Master of Science (Honours) - ResearchDirect

Changes in direction of cancer research over the 20th century:

What prompted change -

research results, economics, philosophy

Jennie Burke

Master of Science (Honours)

A thesis submitted to the

University of Western Sydney

April 2007

© Jennie Burke 2007

Changes in Cancer Research: Research Findings, Economics, Philosophy Jennie Burke – April 2007

Dedication

This research is dedicated to the cancer patients who have so willingly shared their

stories with me over the last two decades, and to future patients who will hopefully

fare better.

I also dedicate this work to my darling grand-daughter, Sophia, and to her generation

in the hope that, by her adulthood, cancer will be prevented rather than treated. If in

the future treatment for cancer is necessary, my wish is that such treatment will be

humane and patient focused.


Acknowledgements

I wish to thank my supervisor, Stuart Hill, for his patience, support, good cheer and

assistance in all facets of this work. I am indebted to my brother, Michael Howe, for

his support, critiques and his wealth of knowledge of the legal system in Australia.

My thanks and appreciation must go to Dr. Karen Bridgman and Professor Andras

Szasz for their support, wisdom and scholarly advice. My friends who are medical

practitioners have cheerfully spent long hours in discussion relating to this study, and

I thank them for their patience and clear-sightedness. Thank you to Megan Mathews

and Giselle Cooke.

During the writing of this thesis, I have been privileged in having the support of two

exceptional scientists. Firstly, Dr Horace Drew III, a molecular biologist of world

renown, has provided advice on matters of science. I am convinced that his open-

mindedness, intelligence and curiosity, if shared by the majority of scientists, would

improve all areas of science. Dr Maxine McCall has shown amazing patience in

spending time with me in discussion and in listening to my airing of concepts. I

thank you both.

My daughters, Kerri and Moya, have offered support and encouragement in this

endeavour and have never doubted my ability to finish this work. The staff at my

laboratory have also given help and support in large quantities. Jane Howard, Linda

Tutty and all the staff have worked harder to compensate for the time I have taken

off while writing. Their help has been most appreciated.

I would like to express my sincere appreciation for the time given in proof reading by

both Robert Gammal and Sharon Millyard. Without Sharon’s assistance, in

particular, this paper would not have been finished in a timely manner.

I thank you all very much for your assistance in bringing this thesis to reality.


Statement of Authentication

The work presented in this research is, to the best of my knowledge and belief,

original except as acknowledged in the text. I hereby declare that I have not

submitted this material, either in full or in part, for a degree at this or any other

institution.

… …

Jen


Table of Contents

Abstract 1

Introduction 2

The Origin of This Study 2

Investigating Links Between Bacteria and Cancer 2

Challenging Scientific Tenets 3

Questioning Medical Doctrines 4

Addressing the Medical Paradigm 5

Direct Conflict with the Medical Establishment 7

Scope of the Study 9

Organisation of the Research 10

Part I: Background 10

Part II: Research Findings 10

Part III: Economics 11

Part IV: Philosophy 11

The Hypothesis 12

PART I BACKGROUND 14

Chapter 1 Methodology 15

Literature Review Using a Hermeneutical Approach 16

Case Studies 17

Qualitative Interviews 18

Literature Survey: Sources 20

Criticism in the Popular Press 20

Literature that Focuses on Quality of Life 21

Questioning the Medical Power Base 21

Questioning the Influence of Industry 22

Challenging the Halls of Academe 23

Promise or Statistics 23

Sources for Statistics 24

Conspiracy Theories 24

Investigative Journalism 24

i


Historical Sources 25

Philosophical Sources 25

Sources for Social Systems 25

Scientific Sources 26

Newspapers, the Popular Press and Websites 27

Governmental and Legal Sources 27

Interpretation and Bias 27

Literature in the Context of People 28

Chapter 2 A Century of Cancer Statistics 31

19th Century Death Toll from Tuberculosis 32

20th Century Death Toll from Cancer 32

Escalation of Cancer to the Leading Cause of Death 32

Increase of 245% in Cancer Deaths over 60 Years 33

Australian Cancer Rates 33

Future Predictions 33

Demographics of Cancer Increase 34

Increase in Smoking-Related Cancers 34

Increase in Cancers Caused by Infection 34

Effect of Affluence on Survival Rates 34

Increase in Hormonal Cancers 35

Measures of Success: The Death Rate 35

Death Rate Statistics 35

Australian Figures 35

USA Figures 35

Cancer Deaths in the Third World 36

Misclassification of Cancer Deaths 36

Cancer Deaths Classified as ‘Other Causes’ 37

Deaths from Cancer Treatments 37

Disagreement Between Diagnosis and Autopsy Results 38

Are Published Figures Correct? 39

Measures of Success: ‘5-Year’ Survival Rate 39

Are Treatments Increasing Cancer Statistics? 41

ii

Chemotherapy Drugs As Carcinogens 41


Radiotherapy As a Carcinogen 41

Conclusions 42

PART II RESEARCH FINDINGS 45

Chapter 3 History of Cancer Research: Cause and Treatment 46

Early Cancer Research 47

Earliest Mentions of Tumours: Humors or Black Bile 47

18th Century: Tissue Capable of Destructive Growth 47

19th Century: Tumours Derived from Normal Cells 48

Cancer from Normal Tissue, Metastasis via Blood or Lymph 48

1920s: Respiration in Cancer Cells 48

1928: Dismissal of Theory of Causal Parasite in Cancer 49

Epidemiology of Cancer 49

Early Recognition of Tobacco As a Causal Agent 49

1950s: Epidemiological Studies of Smokers 50

Enzymatic Studies of Cancers 50

Genetic Studies of Cancer 51

Gene Repression from Oncogenic Agents 51

DNA and Genome Mapping 51

Discovery of the Breast Cancer Gene BRCA 1 51

Recognition of Viruses as a Causal Agent 52

A Century of Chemotherapy Treatment 52

The First Chemotherapy Drugs 53

Chemotherapy Usage 53

Newer Treatments 54

The ‘Magic Bullet’ 54

A Century of Radiotherapy 54

First Clinical Uses 54

Research into Heavy Particles 55

Utilising Radiation Damage to Cells 55

New Radiation Regimes 55

A Century of Surgery 55

Radical Mastectomy 56

iii


Modern Surgery 56

Success Dependent on Surgeon’s Skill 56

Forms of Surgery 56

Results of Research 57

Losing the War on Cancer 57

Epithelial Cancers Increasing and Difficult to Treat 57

Chemotoxic Agents Have Little Impact on Most Common Cancers 57

A New Paradigm—Understanding Therapeutic Resistance 60

Tamoxifen Has Negative Effects on Survival from Breast Cancer 61

Response Rate to Oncology Drugs Only 25% 61

Postoperative Radiotherapy Increases Mortality 61

Future Harm from Radiotherapy 62

Conclusions 62

Chapter 4 Bacterial Involvement in Cancer 67

Early Research on Bacteria 67

Pasteur: Bacteria as Cause of Disease 67

Koch: The Rise of Bacteriology 68

Koch's Postulates 68

Monomorphism 68

1884: Tumours Contain Parasites, But Are Not Caused by Parasites 69

1889: Parasites Found in Cancers 69

1885: Cancer Vaccine from Bacteria 70

1899: Histology Shows Parasites in Active Parts of Tumour 70

1911: Virally-Induced Cancer 70

1925: Micrococcus Cultured from Breast Cancer 70

1925: Cancer Induced by Virus with an Irritant 71

1930: Pleomorphic Forms from Cancerous Tissue 71

Further Studies on Pleomorphic Forms 71

1941: Pleomorphic Forms from Hodgkin’s Lymphoma 72

1948: Siphonospora from Cancer Tissue 72

1952: Pleomorphic Studies of Micromyces 73

1955: Cancer ‘Virus’ Extracted from 1000 Cancers 73

Early Drugs Utilising Bacterial Effect on Virus 74

iv


1955: Dark Field Microscopy Reveals Pleomorphic Forms in Blood of Cancer

Patients 74

1959: Scientist Self-Inoculates with Carcinoma Isolate 74

1948–1990: Livingston-Wheeler et al, Pleomorphic Studies on Neoplasms 75

1966: Studies on the Rous Virus As a Pleomorphic Form of Mycoplasma 76

1969: Livingston-Wheeler Cancer Clinic and Autologous Vaccine 76

Late 1990s: Positive Responses from Clinic Patients 76

1973: Link Between Bacterial Endocarditis and Colorectal Carcinoma 77

1970s–1980s: Histology of Pleomorphic Forms in Cancers 77

Cell Wall Deficient Forms and Mycoplasmas 77

1993: Mattman on Cell Wall Deficient Forms 78

Late 20th Century: Mycoplasmas in Gulf War Syndrome Patients 78

Mycoplasmas Inducing Chromosomal Instability and Malignancy 79

Affinity of Mycoplasmas for Cancer Cells 79

Stats on Infection of Cancer Patients with Mycoplasmas 80

Connection Between Helicobacter pylori and Gastric Cancer 80

Early Misclassification of Mycoplasmas and Cell Wall Deficient Forms 80

Renewed Interest in Bacterial/Viral Induction of Cancer 81

High Incidence of Infection in Cancer 81

Salmonella Infections Linked to Gall Bladder Cancer 81

Chlamydophila pneumoniae in Lung Cancer 81

Escherichia coli and Streptococcus bovis in Colon Cancer 82

Infection in Oral Squamous Cell Carcinomas 82

Conclusions 82

Chapter 5 Paths Not Followed 86

Environmental Carcinogens 86

Role of Industrial Chemicals in Cancers 87

Cancer Clusters 87

The Danger of Close Proximity to Industry 87

The Danger of Close Proximity to Pesticide Use 88

Endocrine Disrupters in Cancer Formation 89

Known Carcinogens in Foods and Personal Products 89

Talc As Carcinogen 90

v


A Sweet Danger 90

NIH List of Environmental Carcinogens 93

Unconventional Medicine 94

Complementary and Alternative Medicine (CAM) 95

'Fringe' Science? 95

Criteria for 'Alternative' Classification? 96

Herbal Medicine 96

Traditional Healing Methods 96

Effect of Scientific Medicine on Traditional Healing 97

Integration of Scientific Medicine into Traditional Systems 98

Non-Delivery of 'Cure' by Conventional Medicine 98

Obstacles to Proving New Medical Treatments for Cancer 98

Cost of Clinical Trials 99

Resistance to Change 99

Rejection of Herbal Medicine by Orthodox Practitioners 99

Unchanged Attitudes: Dr Rush (18th Century) to Dr Dwyer (21st Century) 100

Synergism in Naturally Sourced Drugs 101

Herbs that Are Cytotoxic to Cancer Cells 102

Andrographis paniculata and Uncaria tomentose 102

Scutellaria barbatae 102

Curcumin 102

Artemesia annua 103

Mistletoe Lectin 1 (Iscador) 103

Modern Use of Mistletoe 104

Nutritional Medicine 105

Gerson Diet 105

Gerson Therapy: Negative Reviews 106

Explanation of Gerson Therapy 106

Controlled Food Intake 107

Lack of Studies on Overeating 107

Therapeutic Foods 107

Attitudes to Nutritional Supplements by Oncologists 108

Studies on Micronutrients in Cancer Treatment 108

vi


Immunotherapy 109

Early Work: Dr Coley 110

Revival of Interest in Immunotherapy 110

Anticancer Effect of Newcastle Virus 111

Newcastle Virus Vaccine 111

Phase II Study on Newcastle Virus 112

Other Research on Vaccines from Bacterial Isolates 113

Hyperthermia 113

Early Use of Hyperthermia in Immunotherapy 113

Electro-hyperthermia 114

ECT (Galvanno Therapy) 115

Patient Choices and Information 116

Sources of Information on CAM 116

Common Choices of Therapy 117

Demographics of CAM Users 117

Interest in Prayer and Spirituality 119

Patients with More Aggressive Cancers More Likely to Choose CAM 119

Paediatric Patients Choosing CAM Therapies 120

Adult Cancer Patients Choosing CAM Therapies 121

Attitudes and Understanding of Oncology Practitioners 121

Oncologists Surveyed on CAM Therapies 121

Lack of Understanding of CAM Therapies 122

Bias in Medical Journals 123

Bias Against Acupuncture 124

Quackwatch 125

Australian Skeptics 126

Conclusions 126

PART III ECONOMICS 138

Chapter 6 Following the Money 139

Growth of Pharmaceutical Companies 139

Wealth and Power of Pharma 140

Excessive Profits on Prescription Drugs 140

vii


Importance of Patents 142

Cost of New Drugs 143

Fair Price? 144

Loss of Patent: Generic Drugs 144

Extending the Life of a Patent 145

Drug Patents and Generic Drugs 145

Extending a Patent for Testing on Children 146

Patent Buyouts 146

Patent Lawsuits 146

Abbreviated New Drug Application (ANDA) 147

The Cost of Protecting Patents 148

Research & Development 149

Decrease in New Drug Development by Pharma 149

R & D in Government Laboratories 150

Public Funding, Corporate Gain 150

How Much Does Pharma Spend on R & D? 151

Profits from New Drug Exploration 152

Pharma and Governments 153

Growth of the US Food and Drug Administration (FDA) 153

FDA Funding for New Drug Approvals 154

Reduced Funding for Monitoring Drug Safety 154

FDA Suppression of Commercially-Sensitive Data: the Vioxx Scandal 155

FDA: Servant of Industry? 156

Lack of Constraints on Pharma 156

British Pharmaceutical Industry—‘Voluntary’ Code of Conduct 156

Ineffectiveness of ‘Naming and Shaming’ 157

Australian Pharmaceutical Benefits Scheme (PBS) 158

Reference Pricing to Keep Prices Low 158

Politics and Industry Put Pressure on the PBS 159

Government Staff Become Industry Lobbyists 159

The Tambling Review 160

Repercussions of the Free Trade Agreement on Australia’s PBS 161

What Price Political Influence? 162

viii


Donations to Australian Political Parties 162

Donations to USA Political Parties 163

Pharma and the Medical Profession 165

Importance of Doctors to Pharma 165

Industry Support of Universities 166

AMA Code of Ethics 166

Medical School Funding by Industry 167

‘Financial’ Barriers to Oral Chemotherapy 167

Discount Drugs 168

Visits From Drug Representatives 168

Managing Drug Company Gifts 169

Payments to Doctors to Prescribe Drugs 169

Drug Samples as a Marketing Technique 170

Effects of Drug Marketing on Level of Medical Care 170

Continuing Medical Education (CME) for Doctors 171

Pharmaceutical Company Funding of CME 172

Prescribing Habits Affected by Industry-Funded Meetings 173

Pharma and the Medical Journals 173

Drug Advertising in Journals 174

Papers by Industry Ghost Writers 175

Lack of Independent Peer Reviewers 175

Pharma and the Patient: Direct to Consumer Advertising 176

Effect of DTC Advertising on Doctors’ Prescribing Habits 176

FDA Allowing Prescription Advertising 177

Third Party Technique by PR Companies 177

Benefit for Patients? 178

Pharma and Marketing 178

Pharmaceutical Marketing Budgets 178

Marketing Through ‘Scientific Experts’ 180

Litigation 181

Fraudulent Drug Pricing and Marketing Conduct: Boston 182

Overcharging US Medicaid Through Relabelling: USA 182

Rigging of Vitamin Prices: USA, Europe and Australia 183

ix


Blocking Access to Generic Drugs: Europe 183

Stockpiling Inventory to Overstate Revenue: USA 184

Off-Label Marketing and Conspiracy: USA 184

Multiple Ill-Effects of Drugs: USA 185

Conspiracy to Inflate Drug Prices: Class Action, USA 185

Misleading the Patent and Trademark Office: USA 186

‘Transfer Pricing’ to Offshore Low-Tax Countries: USA 186

Inadequate Testing of HRT Drugs: Class Action, USA 186

Pharmaceutical Industry has Highest Lawsuit Count in USA 186

Conclusions 187

Chapter 7 Academic Freedom—Academic Funding 195

History of the University 195

Autonomy of Universities Under Threat 196

Following the Corporate Model 197

Bias in Research Reports 197

Governments, Grants, Endowments and Industry 198

Fellowships in Science 198

Growth of Government Funding 199

The Advent of Corporate Sponsorship 199

Corporate Funding in Australia 199

Industry Funding of CSIRO 201

Industry Funding of Teaching Hospitals 203

Money and Ethics—Conflict of Interest 204

Private Funding at the Karolinska Institute in Sweden 204

Private Funding at the University of California Berkeley 204

Concerns from Senate Hearing Into UCB/Novartis Collaboration 205

The Biotechnology Boom and Tax Benefits 206

Congressional Hearings: Concern About Autonomy 206

Case Study: Michigan State University 207

‘True’ Science? 208

Conflict of Interest at Harvard University 208

Academic Staff as Shareholders 210

Further Conflicts of Interest 210

x


Dirty Money 211

Funding from the Tobacco Industry 211

Studies Show Industry-Positive Bias 211

Australia Phases Out Tobacco Company Support 212

Conclusions 213

PART IV PHILOSOPHY 216

Chapter 8 The Philosophy 217

Ethics and Philosophy: Are They the Same? 217

Resistance to Change 218

Conservatism in Medicine: the Cartesian Approach 219

Moral Judgements in Medicine 219

University Ethics Committees 220

Does Medical Philosophy Exist? 220

The Ethics 221

Helsinki Declaration 221

Australian Medical Association (AMA) Code of Ethics 222

Swearing of Oaths in Australian Medical Schools 222

World Medical Association (AMA) Code of Medical Ethics 223

Shift in Responsibility from the Doctor–Patient Contract 224

Ethics in the Legal Profession 224

Protectionism Among Medical Practitioners 225

Self-Regulation within the Medical System 226

Conflict of Interest in Bioethics 227

Doctors’ Relationships with Industry 227

Industry Funding Throws Doubt on Research Results 228

Paradigm Shifts 229

Signs of Self-Delusion? 229

Prevention or Early Diagnosis? 231

Calls for a Paradigm Shift 231

Opposition to Paradigm Shifts 232

A Doctor’s Philosophical Stance 233

Honesty in Discussing Treatment Options 233

xi


Misinformation to Patients 234

Oncologists Lack Interest in ‘Other’ Treatments 235

What Treatments Would Doctors Choose? 235

Informed Consent or Informed Choice? 236

GEMZAR: “Overall Survival Difference ... Not Significant” 237

The Ethics of Accepting Money from Pharma 238

ASIC Recommendations 238

Influence on Prescribing Habits 238

Cancer Care As a Corporate Entity 239

The Patients 240

‘Experts’ Promoting Fear 240

Patients As End-Users 241

Consumer Power: Ford Pinto 241

Consumer Lack Of Power In Medicine: Merck/Vioxx 242

Lack of Impartial Government Regulation 244

Patients’ New Role in Their Own Health Management 244

Changing View of the Doctor 245

Fear of Death in Modern Western Culture 246

Planning for a Good Death 246

Balancing Quality of Life Against Length of Life 247

European Attitudes to Cancer Patients 247

Cultural Differences in Science and Medicine 248

Conclusions 249

Chapter 9 Autopoietic Systems—A Biological Analogy 256

Autopoietic Systems 256

The Concept of Autopoiesis 256

Maintaining Autopoiesis 257

Language As Communication 258

Plain English in Legal Texts 258

Structure of the Medical System 259

Maintaining Autopoiesis by Self-Production 260

Boundaries of the Medical System 260

xii


Self-Regulation Within the Medical Structure 262

Is Self-Regulation in Medicine Working? 263

History of Medicine as a Profession 264

Suppressing the Competition 264

Abuse of Privilege 264

Dealing with Offenders 265

Negative Response to Whistleblowers 265

Medical School Encouraging a Guild Mentality 266

Structural Coupling 266

Structural Coupling with the Pharmaceutical Companies 267

Effects of Divergent Goals of Medicine and Pharma 267

A Biological Analogy 268

Parasitisation by Industry 268

Conclusions 269

CONCLUSIONS 273

Indicative Research Findings 273

Indicative Economics Observations 274

Indicative Philosophy Observations 275

In Conclusion 276

REFERENCES 279

APPENDIXES 304

Appendix 1 World Medical Association: Declaration of Helsinki 305

Appendix 2 Hippocratic Oath—Classical Version 310

Appendix 3 Pledge—World Medical Association 311

Appendix 4 Hippocratic Oath—Johns Hopkins University 312

Appendix 5 GEMZAR Phase III Trial 313

xiii


List of Tables

Table I-1: Publications Indexed in PubMed on Bacterial Involvement in Cancer

1960–2001 4

Table 3-1: Direct evidence from randomised studies on the question of whether

palliative chemotherapy prolongs survival 58

Table 3-2: Indirect evidence on the question of whether palliative chemotherapy

prolongs survival. 59

Table 4-1: Mycoplasma Infections in Cancer Patients 80

Table 5-1: Apoptosis in MOLT-4 Leukaemia Cells 103

Table 5-2: Effect of Miso and Tamoxifen on Induced Mammary Tumours in Rats108

Table 5-3: Effect of Miso and Tamoxifen on Established Mammary Tumours in

Rats 108

Table 6-1: Profits by US Pharmaceutical Companies 141

Table 6-2: Profits by World’s Largest Pharmaceutical Companies 142

Table 6-3: Donations to Australian Political Parties by the Pharma/Health Industry162

Table 6-4: Pharmaceuticals/Health Products — Long-Term Contribution Trends 163

Table 6-5: Pharmaceutical Manufacturing — Long-Term Contribution Trends 164

Table 7-1: Funding of CSIRO 201

Table 7-2: Commercialisation in Universities, Medical Research Institutes and

CSIRO in 2001 202

Table 7-3: Commercialisation in Universities, Medical Research Institutes and

CSIRO in 2002 202

xiv


List of Figures

Figure 3-1: Success Rates for Chemotherapy, Radiotherapy and Surgery 58

xv

Changes in Cancer Research: Research Findings, Economics, Philosophy Jennie Burke – April 2007 Abstract

Abstract

This research examines the changes in cancer research and treatment over the 20th

century through to the present date. The aim of the research is to consider which of

three factors—research results, economics or philosophy—was most likely to have

induced change.

Although it is not an in-depth assessment of the current state of knowledge of cancer

research, the thesis does provide an outline of critical changes in knowledge of both

cancer cause and treatment. Treatments that are used routinely by conventional

medicine are examined. Also investigated are areas of research that aroused interest

in the earlier parts of the last century but were then ignored, only now being

revisited.

I examine whether economic factors guided research and whether that guidance was

directed towards specific ends. The influence and extent of infiltration, if any, by the

pharmaceutical industry into the sphere of medicine was also investigated.

The philosophy of medicine is discussed, with particular emphasis on the differences

between ethics and philosophy. The philosophy of the profession itself (or lack

thereof) may have contributed to decisions on whether to adopt or discard particular

research studies and treatments.

I postulate that the medical system, with oncology as one sub-set, may be viewed

using the Maturana and Varella (1980) concept of an autopoietic system.1 Using this

analogy, the structural coupling of medicine with industry shows the change that this

autopoietic system has undergone to survive. Whether the changes required for

survival by the system then produce benefit for the greater environment—the public

in general and cancer patients as a specific instance—is examined.

1

1 Maturana HR & Varela F (1980), Autopoiesis and Cognition: The Realization of the Living, Reidel,

Dordrecht, The Netherlands.

Changes in Cancer Research: Research Findings, Economics, Philosophy Jennie Burke – April 2007 Introduction

Introduction

Research into cancer has changed significantly during the 20th century. The aim of

this study was to investigate the reasons for this change in direction. Three likely

parameters for change are:

Ü Research findings,

Ü Economics, and

Ü Philosophy.

Each of these parameters was examined for its effect on cancer research.

The Origin of This Study

All my working life has been centred around laboratories, in both hospital pathology

and private laboratories. Over the last 20 years I have seen great changes in the type

of work and in the nature of laboratories themselves.

Training in routine pathology predisposes laboratory scientists towards rigid belief

patterns that support orthodox scientific views. Our science would not work at all if

our beliefs did not form a strong foundation for our actions. It is commonly

assumed that the fundamentals of our laboratory training are indisputable.

As Thomas Kuhn (1962) states in The Structure of Scientific Revolutions:

Normal science often suppresses fundamental novelties because they are necessarily

subversive of its basic commitments.1

Investigating Links Between Bacteria and Cancer

For the past 20 years I have been passionately interested in bacterial pleomorphism,

the phenomenon whereby, under certain conditions, bacteria can change their form

into a different cell type. I have worked with several groups overseas investigating

both pleomorphism and the links between bacteria and cancer.

In my current laboratory, Australian Biologics, we perform Polymerase Chain

Reaction (PCR) testing for the presence of certain species of bacteria that may be

2


present in the blood of patients with a variety of conditions. In 2002, we conducted a

research project with a small number of women with breast cancer and found that

almost 50% of these women tested positive for Mycoplasma species. This figure

correlated with a larger study on multiple cancer types—also examined by PCR for

Mycoplasma—where 39 out of 63 women with breast cancer were positive for

Mycoplasma2.

I became intrigued that there was a long history of investigations into bacterial

induction of cancer, and found it most puzzling that this field of research had

appeared to have been abandoned without earlier studies having been refuted.

One particularly interesting experiment, carried out in 1925, described a gram

positive micrococcus that was cultured from a human breast tumour. This organism,

considered to be possibly one of the streptococcus group, was then inoculated into

mice and dogs, inducing the growth of pre-cancerous lesions in many of the subjects

and, in some cases, resulting in breast cancer. Control mice, inoculated with cultures

of (non-cancerous) streptococcus and staphylococcus, did not develop any lesions.3

Further investigation of the literature led me to many interesting studies that are

discussed further in the History of Cancer Research.

Challenging Scientific Tenets

The presence of bacteria in the blood is considered to be indicative of septicaemia,

which generally causes mortality if untreated. For most scientists working in routine

laboratories, this is such a basic tenet that it is unquestioned. Consequently, research

that has questioned this tenet has generally been ignored.

Mass screening for the presence of bacteria that may be involved in the cancer

process has not occurred, and there has been no systematic testing of cancer patients

for the presence of bacteria. I have not been able to find reports of any study that

tested—and treated—cancer patients for such microbes. Therefore we have no

developed knowledge in oncology of the effect that anti-microbial treatment may

have on the prognosis of such patients.

3


The belief that bacteria have no involvement in the cancer process was not held in

the earlier part of the 20th century, but interest in this possibility lost popularity by

the middle of the century. Now, 50 to 60 years later, research is being done and

papers are being published, postulating that at least some cancers are of viral or

bacterial origin. A search of PubMed4, using the terms ‘bacteria’ and ‘cancer’,

yielded the following:

Table I-1: Publications Indexed in PubMed on Bacterial Involvement in Cancer

1960–2001

Years Number of Publications

1960 – 1970 7

1970 – 1980 127

1980 – 1990 414

1990 – 2000 1222

2000 – 2001 334

2005 – 2006 2252

The loss of so many years of potentially productive research on bacterial

involvement in cancer has led me to question why such interesting fields of cancer

research have been abandoned and taken so long to reappear? Why do particular

lines of research flourish whereas others are neglected?

I felt there was a need to examine the paths research has taken over the last century

and to identify the factors that influence and determine which lines of research are

followed. Was any hierarchical structure involved that contributed to such

decisions? Was it a question of finance, of who would fund such studies or whether

a profit margin might contribute to a decision to follow a particular line of thought?

Questioning Medical Doctrines

The medical science paradigm has patriarchal grounding, which emphasises control

through objective rationality and separation between observer and observed.5

During medical school, students are expected to memorise a massive amount of

detailed information, all provided by lecturers, professors and textbooks and

regurgitated in exams. Critical examination of this information and questioning of

the validity of these so-called facts is not encouraged. This is possibly because of

4


time constraints, but is more likely a result of the assumption that these ‘facts’ are

immutable truths. Teaching methods in medicine tend to encourage the

‘subservience’ of students. A medical practitioner (M.M.) told me in an interview,

“We were expected to stand with head bowed, and hands clasped either in front of or

behind the body”.

This conditioning of the ‘acolytes’ at the beginning of their careers does not promote

critical thinking or questioning of any of the tenets of the medical profession.

Instead, it promotes a devotion to the medical doctrine espoused. As Griffin stated in

1995:

By a linear process of mind that cannot ultimately be separated from the desire for

domination by both church and state, a nearly invisible idea of hierarchy in science has

determined both its epistemology and its methodology. What was once divine authorship

has been replaced by the myth of objectivity, an imagined position which, like the

Christian idea of the divine, is not embedded in nature, and from which truth alone can be

perceived. The absolute truth of religion has been replaced by the abstract principles of

science, as if the numbers or statistics were intrinsically beyond doubt, even by

quantification. And just as religious doctrine placed the sacred above the profane,

scientific theory has been placed above experience itself, while socially the scientific

establishment has come to occupy the same position of authority once held by the

church.6

Addressing the Medical Paradigm

The antagonism of the orthodox medical world to any criticism of medicine was

discussed in an article by Dr Eveleen Richards of the Department of Science and

Technology Studies at the University of Wollongong and quoted by Carter in

Racketeering in Medicine7:

“According to the revised view, these conflicts must be treated as essentially political

issues where there are no impartial experts. The medical expert must be seen as a

necessarily ‘partisan participant’ in a political debate, not as an apolitical arbiter of

medical truth, and this implies a radical review of the expert’s role in therapeutic

evaluation…. The difficulties of the enterprise, however, are not to be underestimated.

The institution of medicine has a great deal invested in the perpetuation of the myth of

objective evaluation. It underpins the cognitive and social authority of its practitioners

and legitimate powerful vested interests, not only in medicine, but in society at large.”

5


In 1998, when invited to address a Rotary Club, I suggested that I call my talk “The

Politics of Cancer”. The audience included three medical practitioners. As I

discussed the monetary interests involved in medicine and the extent to which these

interests may decide the range of research conducted, these doctors became more and

more agitated. Towards the end of my talk, one doctor leapt to his feet, pointed his

finger at me and announced, “You would be the type of person who, if your child

had leukaemia, wouldn’t allow them to have chemotherapy!” I found it

extraordinary that a discussion of possible corruption in the ‘system’ of their

profession would be regarded as a threat, and would provoke such an astonishing

personal attack.

Another experience that caused me to question the objectivity of medical doctors

occurred when, in 1988, a friend (P.S.) organised a talk for medical students at the

medical school of an Australian University. The talk was given by the head of a

holistic cancer clinic based in Mexico.

In the early 1980s, while in her late twenties, P.S. was diagnosed with malignant

melanoma. She underwent surgical removal of the tumour and was told that a clear

margin had been taken and she would be ‘fine’.

Within six months, she had developed a secondary tumour in the lymph node at the

groin. She visited three local oncologists, who all agreed that the melanoma had

metastasised and that she had only around half a year to live. She declined palliative

treatment in her home city and travelled to Mexico, where she underwent several

months of treatment at a hospital headed by Dr. Rodrigo Rodriguez. She returned to

Mexico several times over the next few years to continue treatment. The talk at the

university was arranged by my friend when she had been three years in remission.

I was present at the talk, where Dr Rodriguez discussed the use of intravenous

vitamins, injectable amygdalin and various other complementary treatments used at

his hospital. At the end of the talk, one of the professors from the medical school

launched into a very derogatory critique of these supposedly unscientific methods.

With many of the students laughing in response to the witticisms of their professor,

6


my friend became upset and stood to announce that Dr Rodriguez had saved her life

when he successfully treated her for secondary melanoma. The professor asked her

how long ago this was. On being informed that the metastases had been found three

years earlier, he pointed at P.S. and exclaimed “You have two years to live”. This

professor had been one of the oncologists who had given P.S. a prognosis of around

six months.

I found this display extremely disturbing on two levels. Firstly, there was no attempt

at any rational discussion of the benefits or otherwise of Dr Rodriguez’s treatments.

Secondly, a person charged with instilling the qualities needed in medical students to

make them caring, ethical practitioners seemed to be gleefully wishing death on

another to support his clearly biased position.

Fortunately, the professor’s prediction of two years was as inaccurate as his earlier

prediction of six months. My friend, more than twenty years after the original

melanoma, is still alive and well today.

Direct Conflict with the Medical Establishment

In 1994 I convened in Sydney an international congress (The First World Congress

on Cancer), bringing together scientists and clinicians from 13 countries to discuss

and present cutting-edge research on new cancer treatments. The resulting

interaction and conflict between myself and what appeared to be the organised

cancer business in Australia strengthened my concerns about the cancer

establishment.

The presenters were well-credentialed and reputable, many holding tenure in

universities and others acknowledged as authorities in their own countries. The

speakers included:

Ü Professor Bjorn Nordenstrom, the inventor of both the fine needle biopsy and

ECT, an electro-galvanic treatment for solid tumours,

Ü Professor Wassilij Gudov, a most honoured and decorated scientist from what

was previously the USSR,

Ü Professor Wolfgang Köstler, President of the Austrian Society of Oncology,

7


Ü Dr. Hans Neiper, Past President of the German Society of Oncology, and

Ü Professor Kedar Prasad, President of the International Cancer and Nutrition

Society and Head of the Centre for Vitamins and Cancer Research at

Colorado University.

A telephone conversation with an executive director of a leading cancer research

organisation was one of the first indicators of problems to come. I had approached

the organisation for assistance in notifying appropriate associations and groups of the

congress. When I informed them of the range of treatments to be discussed, he

refused assistance and stated that “all that these people have is anecdotal evidence

from survivors”.

I had assumed that there would be widespread interest in these new and promising

approaches to cancer research among Australia’s oncologists.. I was surprised,

perhaps naively, by their conspicuous absence from the congress and by the

virulence of the attacks that followed.

A media battle ensued that paradoxically helped the congress to become a great

success. It also demonstrated to me the absolute refusal of the medical establishment

to have open discourse with any scientist, clinician or medical researcher who works

outside the narrow world of chemotherapy, radiotherapy and surgery.

Dirty tricks were used in an attempt to sabotage the conference. Although 25 000

brochures were sent by road transport to the offices of the Doctors’ Weekly for

inclusion in their magazine, mysteriously they disappeared and were never

recovered.

Leading Sydney oncologists and members of the NSW Cancer Council suggested

that treatments such as intravenous vitamin C, coffee enemas and vaccines should be

avoided as they could kill patients, and published articles in Sydney newspapers

decrying the congress.

8


This had a major impact on my life and my beliefs. It initiated a growing interest in

the ‘politics of cancer research’ and it certainly played a role in my resolve to carry

out this research.

Since 1985 many cancer patients have been tested in our laboratory. Many are using

a combination of conventional therapy with adjunctive complementary therapies. I

have been fortunate to have developed relationships with many of these people.

Some are short-term relationships: we may only meet a few times. I have come to

know other patients well, after conversations that have spanned a dozen or so visits.

Many have asked questions that are not easy to answer. My resultant search for

answers has also prompted this investigation.

Scope of the Study

It is not in the ambit of this research to provide a complete listing of cancer

treatments and the changes in science that have led us to where we are today. I have

attempted to provide only an overview.

My examination of research paths not followed is intended as an indicative rather

than a definitive guide to promising research that has been ignored.

My intention is not to belittle in any way the dedicated work of doctors. I have the

highest respect for medical practitioners who devote their lives to healing and to their

patients. I do, however have serious concerns as to the state of the medical

profession in its entirety.

My overview of cancer statistics should be regarded as just that—an overview. Any

criticisms of universities, government institutions or regulatory bodies relate to

events that have been often extensively reported prior to this research.

Oncology has increasingly become a reductionist based dogma perpetuated by what

is, in practice, a closed system, imprisoned by its boundary conditions. Medical

science has developed extremely stringent boundaries—maintained by biased peer

review, doctrinal teachings in medical schools and by selective funding—that must

9


conform to the current medical model. Closed systems may tend towards

equilibrium but by their very nature also tend towards entropy.8

Organisation of the Research

Part I: Background

Chapter 1, Methodology, gives background to the researcher and to the methodology

used in investigating changes in cancer research. It also discusses the background

literature that has formed a framework for the investigation and prompted many of

the questions raised.

Chapter 2, A Century of Cancer Statistics, sets out statistics relating to cancer

occurrence and cancer deaths, and analyses the changes and increases in these

statistics over the last 100 years.

Part II: Research Findings

Chapter 3, History of Cancer Research: Cause and Treatment, gives a brief history

of the developments in cancer research over this last century, in particular, the

exploration by science into cell change, DNA, genome mapping, and epidemiology.

It then examines the development and efficacy of the most popular treatments for

cancer: chemotherapy, radiotherapy and surgery.

Chapter 4, Bacterial Involvement in Cancer, examines the cancer research and

treatments that initially showed promise yet have never been fully explored or

developed. The research into a bacterial involvement in cancer has been largely

ignored or even actively discouraged, through the withholding of research funding

and the negating of research results.

Chapter 5, Paths Not Followed, explores the research on chemicals that are known to

cause cancer but to which we are still routinely exposed in our environment. In this

chapter, I also analyse treatments for cancer that have not been integrated into

conventional oncology. The ongoing control of which treatments to support and

which to ignore has created a rift between clinicians: some became ostracised, some

were labelled quacks, but subsequent research has often confirmed earlier discredited

10


claims as valid. There appear to have been many lost years of research and many

worthwhile research projects ignored.

Part III: Economics

Chapter 6, Following the Money, examines the corporations involved in producing

the drugs and equipment used in cancer treatments. The wealth and power of the

multinational corporations is known to the general public. The use of money by

these corporations to influence, buy and pervert has not been common knowledge.

The use of money to influence doctors’ prescribing habits, to encourage practitioners

to lend their names for use in fraudulent research papers, to influence governments

and government departments—established to regulate these same companies—has

not been common knowledge.

This chapter pursues the argument that the companies are not ethical or moral

establishments: It should not be expected that they be altruistic in their corporate life.

They should also not be allowed to walk away unscathed from the illegalities and

breaches of regulations that so many corporations have indulged in over so many

years.

Chapter 7, Academic Freedom—Academic Funding, examines the role of the

universities, medical schools, and government scientific establishments in cancer

education, research, prevention etc. It is the universities who most influence the

thinking of new doctors; it is the universities who are responsible for the training of

doctors and for the inculcation of a truly ethical and moral relationship between

doctors and their patients. Changes to the funding of universities have had a

profound effect on both the research and the end results of this research. Because

governments are contributing less and less to universities, this is forcing them to look

for finances in other quarters.

Part IV: Philosophy

Chapter 8, The Philosophy, provides an overview of medical philosophy; focusing

particularly on how philosophy has been narrowed to the lesser subsection—ethics.

Medical philosophy is compared with that in another profession, and an overview of

cultural changes affecting the way medicine is practiced in other cultures is provided.

11


The lack of a suitable framework of self-introspection as to the ‘why’ of medicine

has contributed to the ‘what we can do’ attitude.

Chapter 9, Autopoietic Systems—A Biological Analogy, offers another viewpoint of

medicine as a social structure and of the requirements of a social structure to be

determined as ‘autopoietic’. I discuss the tentative hypotheses that medicine, as an

autopoietic structure, has formed an intensive version of structural coupling with the

pharmaceutical industry, and how in the process it has given up the goals and

autonomy that are usually implicit in autopoiesis.

Throughout this study I have used numerical referencing to increase and simplify

readability. In Chapter 1, Methodology, I have also introduced the Harvard system

of referencing when alluding to particular books in general rather than to specific

points or text within that book.

The Hypothesis

My hypothesis is that, throughout the 20th century, oncology became an autopoietic

system: it has established strictly defined parameters and is autonomous and self-

maintaining. Although the processes being discussed apply to the whole medical

system, the focus of this research is only on oncology.

As a self-maintaining entity with very defined boundaries, oncology as a social

structure may have a long and useful life. Knowingly or unknowingly, oncology has,

however, incorporated another discrete and more powerful structure into its system:

the corporate structure of the pharmaceutical companies. This incorporation, and

resultant symbiotic relationship, has formed a very unhealthy alliance.

The anticipated benefits of this research are to not only ascertain why we have our

current system of research and treatment, but also to make some sense of the key

players in what has undoubtedly become one of the largest and most influential

industries world-wide.

12


Key starting questions included the following:

Ü Which sectors involved in cancer research have exerted the most influence on

the directions taken?

Ü How was such influence achieved, and what enabled it to occur?

Ü Who are, or should be, the guardians of science or, according to Juvenal, Sed

quis custodiet ipsos? (Who guards the guardians?)

13

1 Kuhn TS (1962), The Structure of Scientific Revolutions, The University of Chicago Press, Chicago,

IL, pp1-10.

2 Huang S, Li JY, Wu J, Meng L & Shou CC (2001), 'Mycoplasma infections and different human

carcinomas', World Journal of Gastroenterology 7(2): 266-69.

3 Nuzum JW (1925), 'The experimental production of metastasising carcinoma in the breast of the dog

and primary epithelioma in man by repeated inoculation of a Micrococcus isolated from human breast

cancer', Surgery, Gynecology & Obstetrics 11: 343-52.

4 (1950 to current date), 'PubMed, National Library of Medicine, and National Institutes of Health',

National Center for Biotechnology Information, <http://www.ncbi.nlm.nih.gov/>.

5 Miller WL & Crabtree BF (2005), The Sage Handbook of Qualitative Research, Sage Publications

Inc, Thousand Oaks, CA, pp609-11.

6 Griffin S (1995), The Eros of Everyday Life - Essays on Ecology, Gender and Society, Anchor, New

York, NY, p35.

7 Carter JP (1993), Racketeering in Medicine: The Suppression of Alternatives, Hampton Roads

Publishing Company, Norfolk, UK, p10.

8 Hubert C, 'Closed/open systems', viewed March 2006,

<http://www.christianhubert.com/hypertext/closed_open_systems.html>.


PART I

BACKGROUND

14

Changes in Cancer Research: Research Findings, Economics, Philosophy Jennie Burke – April 2007 Chapter 1 – Methodology

Chapter 1

Methodology

My investigation is primarily a retrospective evaluation focussed on both general

publications and the scientific literature on cancer research, in which issues within

oncology have been raised over many decades. The purpose of my enquiry is to take

a global view of how we have arrived at the conventional treatment modalities that

are currently dominant and to what extent the main influences (research findings,

economics or philosophy) have determined this situation.

Cancer research and, by extension, the treatments resulting from it, affects directly

and/or indirectly a significant proportion of humanity. Discovering the intent, or at

times the motivation, of such a large scale conglomerate as the ‘cancer industry’ is

only possible through an examination of the literature of all parties involved.

From the documentary evidence, I seek to evaluate and question the actions and

structures of the following interrelated groups:

Ü Medical science (as a discreet organism),

Ü The corporations that supply products (such as pharmaceuticals),

Ü The government agencies that direct and regulate this complex industry,

Ü The profession (primarily the medical practitioner), and

Ü The final user: the cancer patient.

The documentary evidence has been gained through both mediate access (examining

evidence in the form of written texts) and proximate access (through interviews and

questioning)1 of a variety of stakeholders, including cancer patients, medical

practitioners and scientists. Because no single method of enquiry appeared sufficient

for the investigation, I have combined the following three styles of qualitative

methodology:

Ü Hermeneutics,

Ü Case studies, and

15


Ü Interviews.

Literature Review Using a Hermeneutical Approach

The large quantity of data that I’ve accessed over time, and the need to extract and

interpret meaning from this data, led me to adopt a hermeneutic approach.

Hermeneutics was originally used in relation to legal and theological issues, but it

has subsequently been developed, based largely on the work of Heidegger2 and

Gadamer3, into a broader methodology for understanding other human issues.

I have aimed to be objective in assessing the texts I have gathered. It is not possible

to be completely objective, however, because our own understanding and history

always unavoidably impinges to some degree on the interpretation of historical texts.

Hermeneutics allows for the historical retrieval of texts, framing them into a re-

construction of meaning in our society. It enables us to deepen our understanding of

the historical past by including our own interpretation of it, and by framing it within

the context of our specific enquiry. Instead of letting the text be limited by the

author’s intent, hermeneutics can be used to place the text into our own history or life

experience, to contribute to our understanding, interpretation and application.4 Betti,

in Teoria dell’Interpretazione5, has argued that text may be regarded as an

objectified representation of human intention.

Early on I decided that hermeneutics would provide me with the best methodological

framework for interpreting and understanding the events (through examination of the

retrieved literature) that have brought us (Western society) to our current state of

cancer research and treatment. As stated by Wiercinski et al in 2005:

Ideas are nested in historical, linguistic, and cultural horizons of meaning. A

philosophical, theological, or literary problem can only be genuinely understood through

a grasp of its origin. Hermeneutics is in part the practice of historical retrieval...6

Documents are produced by people and are by-products of the thoughts and feelings

associated with human experience, both from the present and the past. Sidney and

Beatrice Webb were quoted by John Scott (1990) as having argued that each such

document is:

16


...an instrument in language which has, as its origin, and for its deliberate and express

purpose, to become the basis of, or to assist, the activities of an individual, an

organisation, or a community.7

I have not only provided the historical basis for our current position in terms of

research and treatment (see Chapters 2 and 3), but have also provided a secondary

historical record of scientific research that fell outside of mainstream enquiry (see

Chapters 4 and 5).

Case Studies

I chose case studies as a second methodology to enable me to address the broad and

complex nature of the topic. Yin (1994) defined the case study approach as:

...an empirical inquiry that investigates a contemporary phenomenon within its real-life

context, especially when the boundaries between phenomenon and context are not clearly

evident.8

Although a single case study can be used to form a hypothesis, it can also contribute

to the systematic testing of hypotheses and to the building of a theory (see Ruddin

citing Caporaso et al9). When multiple case studies are carried out (as in this

research) judgements of their ‘typicality’ can be justifiably made.10

My interest in the issues involved in cancer research and treatment preceded the

formal initiation of my research topic. Because of this I had already begun to collect

case studies as a by-product of this interest. To provide enough data to prove my

hypothesis, however, entailed the use of additional collective case studies.11

My investigation into the role of the companies, in relation to my research questions,

involved not only hermeneutic examination of key texts, but also the use of selected

texts as case studies. Information about the companies’ finances and their promotion

of drugs has been obtained by examining these companies’ own documents as well

as texts written about them.

Chapter 6, Following the Money, focuses on many of these companies and on events

that involve them. These events were influenced by a complex of interrelated

17


contextual factors, including both the political and social conditions at the times they

occurred.

Using case study methodology, I selected cases that focused attention on my research

topic and discarded events that were not relevant to my theme. To show the global

nature of events engendered by these companies it was necessary to document

multiple case studies in which the aims and outcomes were shown to be largely

similar across companies, showing that these events were not singular occurrences.

The actions of the pharmaceutical industry have impacted not only on the patients

who are the end-users of the drugs produced, but also on the people working on

health issues in government, universities and the medical profession, particularly

oncologists. Case study methodology was required to assess the impact on all parties

involved. As the phenomenon being researched is broad and complex, multiple case

studies have helped to show the generality of actions, as opposed to a single case

study showing a singular aberrant event.

This methodology was also employed in Chapter 7, Academic Freedom—Academic

Funding, in which I used multiple events to demonstrate the changes that have

occurred in universities throughout the 20th century and leading into our current

decade.

Case studies have been used to examine how the privatisation and commercialisation

of research, and of the universities themselves, have contributed to the control and

direction of streams of research.

In Chapter 6, Following the Money, and Chapter 7, Academic Freedom—Academic

Funding, my case studies are multi-perspectival: I have examined the interactions of

multiple groups—of those touched or affected by the events—rather than just the

isolated events.

Qualitative Interviews

A small but significant part of my investigation involved conducting a series of

interviews. Qualitative interview methodology has enabled me to pose questions to a

18


variety of people in my effort to understand the significance of research changes

historically, and to gauge the human impact these changes have induced. Qualitative

research interviews may be defined as:

... attempts to understand the world from the subjects’ point of view, to unfold the

meaning of peoples’ experiences, to uncover their lived world prior to scientific

explanations.12

Over the period of time of my candidature, I have been invited to present papers at

two annual meetings of the German Society of Oncology (Deutsche Gesselschaft fűr

Onkologie) and at two breast cancer conferences in Canada (see

http://www.wcbcf.ca/).

As a member of the German Society of Oncology for the last 10 years, I have

attended most of the annual meetings and have forged excellent relationships with

many of the attending oncologists from Germany and Austria. This contact has

allowed me to become involved in a series of discussions with European oncologists

relating to the focus of this research.

Presenting at two World Breast Cancer Congresses in Canada enabled me to not only

listen to presentations by a diverse range of researchers, but also to meet and discuss

my interests with them and with others from around the world.

It becomes clear, when participating in such international conferences, that carefully

constructed questions can reveal much about the cultural differences in medicine and

science. Such discussions have contributed to my research, particularly in the areas

of social structure and cultural variations between countries. Chapter 8, The

Philosophy, focuses on the effects on society (and on cancer patients in particular) of

the dominant directions taken in cancer research and the resultant treatments.

Having a work history that has centred on pathology testing has provided me with a

social circle that is also medical-centric. Many of my friends are medical

practitioners and have willingly allowed me to interview them and use them as

sounding boards for musings on my research topic. I have attempted to maintain a

certain distance from my findings to allow objectivity, but the experiences of my

19


friends in dealing with medical establishments, patients and pharmaceutical

companies has given me access to their diverse views of this world.

Because of the nature of my work, I frequently see cancer patients while they are

undergoing conventional treatment. Some patients are regular visitors to our

laboratory, and over many visits a sense of rapport often develops. Many of these

patients have shared with me their stories of their experiences in the medical system.

I have posed essentially the same questions to both patients and doctors through my

qualitative interviewing, and have found considerable similarity in their answers.

However, because most of the medical practitioners I interviewed are holistic in their

outlook, their views would not be expected to be representative of conventional

oncology practitioners. Many of these holistic doctors are involved in cancer

treatment through the provision of adjunctive treatment and life style care.

Interviews and dialogue have provided the foundation of my proximate access to the

data that has shaped this research. Although I have not included many transcribed

interviews, these interviews have nevertheless contributed significantly to my

understanding gained through this research. The voice of the patient first set me on

this enquiry and the other ‘voices’ I have listened to along the way have helped to

form the direction and framework of this work.

Literature Survey: Sources

Many books have been written on topics relating to the central themes of my

research. I have continually evaluated and had to severely cull to arrive at those that

I selected as supporting references. Key criteria were that the books are well

referenced, and that the findings are verifiable.

Criticism in the Popular Press

Established conventional medicine has often been criticised for its failure to

adequately investigate and promote the prevention of cancer, concentrating its

attention instead on treatment and diagnosis. Neglected areas include the

environmental, workplace and dietary causes (and co-factors) of cancer.

20


Epstein (1998), in The Politics of Cancer Revisited, has questioned whether any

significant improvement in treatment and survival rates has occurred over the last

few decades, and he critiques the politics of the cancer establishment in exhibiting an

indifference to prevention strategies.

The issue of pursuing only a relatively narrow path of research—where ‘other’

causes and treatments have not been considered or adequately researched and, in

fact, have often been actively suppressed—has also been raised in Cantwell’s (2005)

Four Women Against Cancer, in Carter’s (1992) Racketeering in Medicine, in

Culbert’s (1997) Medical Armageddon, and in the many journal articles quoted in

Chapter 5, Paths Not Followed.

The usual reason given by the ‘medical establishment’ for this situation, and in

particular for the narrow research agenda, is lack of funding.

Literature that Focuses on Quality of Life

The question of the quality-of-life effects of cancer treatment has been raised by

many authors, especially in the popular press: Schou and Hewison (1999)

“Experiencing Cancer: Quality of Life in Treatment”. Many authors have promoted

a variety of less damaging and less toxic treatments in place of the conventional

more invasive therapies.

It is not my intent to review or discuss the possibilities of such treatments. However,

Moss (1995), in Questioning Chemotherapy, has ably critiqued the results that

current treatments utilising chemotherapy achieve. Also, Ulrich Abels (1992), in

Chemotherapy of Advanced Epithelial Cancer – a Critical Review, has also critiqued

the use of chemotoxics in epithelial cancers, the most common form of cancer and

one that has a very low response rate to chemotherapy.

Questioning the Medical Power Base

Many authors have wondered aloud about a medical establishment that has prevented

or eliminated alternative forms of treatment to maintain its power base, where

business and money are placed before the wellbeing of the patient. Barlett and Steele

(2004), in Critical Condition: How Health Care in America Became Big Business &

21


Bad Medicine, provided an exposé of how devotion to the profit margin has damaged

the medical system in the USA and lessened life expectancy among the population.

This has been further documented in works such as Brown’s (1986) Aids, Cancer &

the Medical Establishment, Walker’s (1993) Dirty Medicine, and Moynihan’s (2001)

Too Much Medicine.

Questioning the Influence of Industry

The role of the pharmaceutical companies in maintaining what appears to be a status

quo (or merely an extrapolation of it) in cancer treatment has been repeatedly

criticised. The relatively recent rapid growth in the power of corporations has

changed the way science is now carried out

Control is now exerted through monetary power, which is a main deciding factor as

to which research paths to follow, how drugs and treatments are promoted, and what

the public are told in publicity campaigns. Both Bakan (2004), in The Corporation,

and Beder (2000), in Global Spin: The Corporate Assault on Environmentalism,

clearly outline the dangers to public interest that corporate priorities and greed pose.

From Le Carre’s (2001) Constant Gardener, in which a pharmaceutical company

that puts profit before life is cast as the villain, to Marcia Angell’s (2004) critique of

Big Pharma in The Truth About the Drug Companies: How They Deceive Us and

What To Do About It, popular literature shows a growing concern about the morality

of the corporations.

As a former Editor-in-Chief of The New England Journal of Medicine, Dr Angell

was placed in a position that allowed her to see clearly the power that Big Pharma

exerted over both government agencies and the clinical trials of drugs. This

influence has rippled throughout the scientific world with revelations of peer

reviewers with no financial interests in industry being almost impossible to find, and

of scientists signing their name to articles ghost-written by industry employees.13 14

Greider’s (2003) The Big Fix: How the Pharmaceutical Industry Rips Off American

Consumers, Korten’s (1995) When Corporations Rule the World, Moss’ (1999) The

22


Cancer Industry and Wohl’s (1984) The Medical Industrial Complex have addressed

the problems inherent in a system where the primacy of economic power enables

corporations to control our health systems.

Challenging the Halls of Academe

Academia’s position has been shown by Krimsky (2003), in Science in the Private

Interest, to reflect a somewhat tarnished Ivory Tower. As government funding to

universities in most countries has declined, the need for universities to turn to

industry for support has resulted in the establishment of an unhealthily close

partnership between medicine and industry. This connection extends from whole

medical schools and research institutes that receive extensive funding, to individual

scientists and clinicians who are funded with monies from industry without openly

appearing as employees of the companies involved.

Payer (1992), in Disease-Mongers: How Doctors, Drug Companies, and Insurers

Are Making You Feel Sick, shows how marketing techniques can create new illnesses

and new uses for drugs to increase profits. Epstein’s (2005) Cancer-Gate: How to

Win the Losing Cancer War critiques the National Cancer Institute in the USA and

documents the American Cancer Society’s conflicts of interest with industry.

Promise or Statistics

The statistics, used both politically and scientifically, that relate to the success of

cancer treatments have been found wanting by such epidemiologists as John Bailar

III 15 in the USA and Ulrich Abel16 of Germany. According to Bailar, the much

publicised War on Cancer, initiated by President Nixon when signing the National

Cancer Act in 1971, has been a qualified failure and a war that has been lost.

With a World Health Organisation health report17 estimating that by 2020 global

rates of cancer could increase by 50%, it is imperative that more attention be paid to

prevention. Although much of this increase in cancer rate may be linked to life-style

factors and poverty, there is also an alarming world-wide increase in hormonal

cancers. Environmental campaigners have often linked this to the chemicals used in

industry and agriculture.

23


Sources for Statistics

Statistics on cancer occurrence and treatment success have been sourced from the

scientific literature, the World Health Organisation (http://www.who.int/en/), the

Australian Government Bureau of Statistics website, (http://www.abs.gov.au/) and

the SEER (Surveillance Epidemiology and End Results) programme database

(http://seer.cancer.gov/).

Conspiracy Theories

Much has been written in the popular press about ‘conspiracy theories’ relating to

drug companies and their financial hold on governments, for example, Griffin’s

(2001) World Without Cancer and Proctor’s (1995) Cancer Wars.

Although much of the popular literature in this field tended towards conspiracy

theories, such as control of medicine by the Rockefeller organisation and other

powerful groups, this did not constitute part of my research. Whether these claims

have any basis in truth is not what I was investigating. Rather, I was impressed by

more reliable sources, such as Richard Horton’s (2001) editorial—Lotronex and the

FDA a Fatal Erosion of Integrity—in The Lancet, and Coombes’ (2005) article Drug

industry’s new code criticised for lacking teeth in the British Medical Journal.

Investigative Journalism

Several Australian Broadcasting Commission investigative journalism productions

(Four Corners Paying the Price) and newspaper articles on revelations by

whistleblowers in government or industry positions have raised issues relevant to my

research. Also, a British House of Commons report (The Influence of the

Pharmaceutical Industry 2004-2005) found that influence by pharmaceutical

companies was excessive and contrary to the public good, and that the interests of

patients, the National Health Service (NHS) and industry were at odds and did not

serve the public well.

Popular press publications such as Rampton and Stauber’s (2001) Trust Us, We’re

Experts, How Industry Manipulates Science and Gambles with Your Future have

also highlighted the control and power of pharmaceutical corporations.

24


Historical Sources

The short history of oncology has been sourced from textbooks such as the

Encyclopaedia of Medical History by McGrew (1985), from International Cancer

Conference Proceedings (starting from the 1920s), journal articles on the history of

Occupational Health, and from the American Cancer Society’s web site on cancer

treatments.

Philosophical Sources

For papers relating to questions of philosophy and social enquiry, Project MUSE,

(http://muse.jhu.edu.ezproxy.uws.edu.au/) and the Journals of Medical Philosophy

were searched.

Most of the literature I relied on to review the philosophy of medicine was from bio-

ethics and philosophy journals. The seminal work of Ivan Illich (1976) questioned

the mechanistic approach of modern medicine in Limits to Medicine. Medical

Nemesis: The Expropriation of Health.

The work of Thomas Kuhn (1962) in The Structure of Scientific Revolutions, on

paradigm shifts in science, explains the difficulties that all fields of science have with

the introduction of new thoughts and insights.

The writings of Erich Loewy18 19 20, Professor and Chair of Bioethics at the

Department of Philosophy, University of California, and his generous personal

communications, were valuable in directing my searching of ethical and

philosophical papers relevant to my research.

Sources for Social Systems

My exploration into the field of closed and autopoietic systems owes much to the

writings of Maturana and Varela (1973) in Autopoiesis and Cognition: The

Realization of the Living, Luhmann (1986) in The Autopoiesis of Social Systems, and

the theorist Gunther Teubner (1988) in Autopoietic Law: A New Approach to Law

and Society.

25


If oncology in practice, in university and in industry has formed a triumvirate that

has morphed into an autopoietic system, then this needs to be clearly recognised.

Paradigm shifts are difficult and often unpleasant for those holding on to a system

that has become redundant, but often such a shift is required to bring about

‘progressive’ change.

All of these areas of literature are relevant to my enquiry, and much has been written

on each specific issue. The need now is to examine the totality of these parts and to

identify how and why the present dominant system of cancer treatment developed.

Only by examining the interrelationships between the diverse issues and the

organisations involved can we be in a position to judge whether our current cancer

treatments are the product of the best that scientific research could offer us over the

past century. If this is not the case, the knowledge of how we came to be in this

position is needed before any beneficial change can occur.

Scientific Sources

The dominant language of oncology (the mode of communication about cancer) is

evident in the scientific papers and textbooks relating to oncology. To preserve

authenticity and language of the documents used in this research, the scientific

papers quoted have been sourced through the Ovid and Science Direct search engines

or PubMed, the National Library of Medicine. The papers quoted are from high-

ranking, peer reviewed journals that are routinely used world-wide by the scientific

community.

Relevant key words were used in searches and often links to related articles

broadened the fields of the searches. Full articles were obtained rather than any

reliance on abstracts as these often failed to reveal essential information.

Although many of the earlier papers would no longer meet today’s criteria for

publication, it was essential that I examined them, taking into account that they

reflected the science of their time.

26


Newspapers, the Popular Press and Websites

Documentary evidence was also sourced through newspaper articles, some

Australian, but many from international newspapers such as The New York Times,

The Guardian, Wall Street Journal and Forbes. I have also examined relevant web

sites, such as Public Citizen (http://www.citizen.org/) and the Centre for Media and

Democracy (http://www.prwatch.org/). These provided many useful articles and

helped to guide my ongoing searching.

Much of the information concerning monetary factors, particularly relating to the

pharmaceutical industry, had to be accessed, at least initially, from the popular press.

I was well aware that documentation obtained via the printed media required an

assessment as to the possibility of the press being used as part of spin-doctoring

campaigns.

Governmental and Legal Sources

In relation to the pharmaceutical industry, I also examined various court and

government documents, especially from the USA. The 2005 UK House of

Commons Health Committee report21 on The Influence of the Pharmaceutical

Industry was particularly useful.

Interpretation and Bias

Scientists’ choice of guiding theory can depend not only on the evidence gathered,

but also on the particular social and political context. This had to be considered

when examining the nature of the scientific evidence.

Similarly, to gain a deep understanding of the interconnectedness of the groups

involved in this investigation required an interpretative approach in relation to

understanding the various events that have occurred. These ‘events’ are evidenced in

the documents that were produced during the time when they occurred. My various

discussions, both in Australia and overseas, were invaluable in helping me to more

fully understand the scientific literature of the time.

27


I was only able to answer my initial question—what forces had prompted and

enabled change in the direction of cancer research?—by discussing this, where

possible, with the people involved.

Literature in the Context of People

Cancer research, by its very nature, cannot be divorced from humans. Whether terms

such as cancer victim, sufferer or patient are used, our concern should always be

primarily with the people who develop this disease. For most cancer patients, the

type of treatment they receive is decided, usually with no discussion of the full

spectrum of choices available to them, by conventional medical oncologists. Only a

minority of cancer patients decide to seek other forms of treatment. Opinions on the

value of alternative treatments, among both conventional oncologists and patients,

are often diverse and emotionally charged.

I was also driven to better understand the thinking and positions of the scientists

involved, whether they were working in government, industry or university. Their

stories were undoubtedly influenced by their social background and a range of

constraints, whether from peer pressure or social changes in general, and by the

effects of increasing commercialisation of science and medicine.

The third group of interest to me in this research was the companies themselves.

Society places relatively clear moral obligations on its members, but corporations are

not necessarily subject to these same obligations. The employees of corporations

may not be held accountable in the same way as individuals within society.

Directors and executives are often legally protected from the end results of their

decisions.

Bakan (2004) notes, for example, that:

The corporation’s legally defined mandate is to purse, relentlessly and without exception,

its own self-interest, regardless of the often harmful consequences it might cause to

others.22

By the end of the 19th century, particularly as a result of a US Supreme court

decision in 1886, the corporation had gained the status of an ‘entity’, imbued with

28


rights to a ‘due process of law’, as would any individual.23 Because of this, case

studies relating to the moral obligations and practices of corporations should be

viewed in the same way as one might view individuals.

29

1 Scott J (1990), A Matter of Record. Documentary Sources in Social Research, Polity Press,

Cambridge, UK.

2 Carman T (2003), Heidegger's Analytic: Interpretation, Discourse, and Authenticity in 'Being and

Time', Cambridge University Press, Cambridge, UK.

3 Gadamer H-G (1989), Truth and Method, translated by Weinsheimer J & Marshall DG, Crossroad,

New York, NY.

4 How AR (2007), 'The Author, the Text and the Canon. Gadamer and the persistence of Classic Texts

in Sociology', Journal of Classical Sociology 7(1): 5-22.

5 Betti E (1955), Teoria generale della interpretazione, Giufre, Milan, Italy.

6 Wiercinski A et al (2005), 'The International Institute for Hermeneutics', University of Toronto,

viewed October 2005, <http://www.chass.utoronto.ca/iih/AboutHermeneutics.htm>.

7 Scott J (1990), A Matter of Record. Documentary Sources in Social Research, Polity Press,

Cambridge, UK.

8 Yin RK (1994), Case Study Research: Design and Methods, Applied Social Research Methods

Series, Sage Publications, Beverly Hills, CA, 2nd Ed, Vol 34, p13.

9 Ruddin LP (2006), 'You Can Generalize Stupid! Social Scientists, Bent Flyvbjerg, and Case Study

Methodology', Qualitative Inquiry 12(4): 797-812.

10 Flyvbjerg B (2001), Making social science matter: why social inquiry fails and how it can succeed

again, translated by Sampson S, Cambridge University Press, Cambridge, UK, pp73-73.

11 Stake R (1995), The Art of Case Research, Sage Publications, Newbury Park, CA, pp3-4.

12 Kvale S (1996), Interviews. An Introduction to Qualitative Research Interviewing, Sage

Publications, Thousand Oaks, CA.

13 Flanagin A, Carey L, Phil B, Phillips S, Pace B, Lundberg G & Rennie D (1998), 'Prevalence of

Articles With Honorary Authors and Ghost Authors in Peer-Reviewed Medical Journals', The Journal

of the American Medical Association 280(3): 222-24.

14 Mowatt G, Shirran L, Grimshaw JM, Rennie D, Flanagin A, Yank V, MacLennan G, Gotzsche PC

& Bero LA (2002), 'Prevalence of Honorary and Ghost Authorship in Cochrane Reviews', The

Journal of the American Medical Association 287(21): 2769-71.

15 Bailar JC III & Smith E (1986), 'Progress Against cancer?' The New England Journal of Medicine

314: 1226-32.

16 Abel U (1992), 'Chemotherapy of advanced epithelial cancer - a critical review', Biomedicine &

Pharmacotherapy 46(10): 439-52.


30

17

(2003), 'Global cancer rates could increase by 50% to 15 million by 2020', World Health

Organization Media Centre, viewed July 2004,

<http://www.who.int/mediacentre/news/releases/2003/pr27/en/>.

18 Loewy EH & Loewy RS (2005), 'Use and Abuse of Bioethics: Integrity and Professional Standing',

Health Care Analysis 13(1): 73-86.

19 Loewy EH (2002), 'Bioethics: Past, Present, and an Open Future', Cambridge Quarterly of

Healthcare Ethics 11: 388-97.

20 Loewy EH (1999), 'Health-Care Systems and Ethics: What Can We Learn?' Health Care Analysis

7: 309-20.

21 (2005), 'The Influence of the Pharmaceutical Industry', UK House of Commons Health Committee:

The Stationery Office Limited, 1: 1-126.

22 Bakan J (2004), The Corporation: The Pathological Pursuit of Profit and Power, Constable &

Robinson Ltd., London, pp1-2.

23 ibid., p16.

Changes in Cancer Research: Research Findings, Economics, Philosophy Jennie Burke – April 2007 Chapter 2 – A Century of Cancer Statistics

Chapter 2

A Century of Cancer Statistics

After all, facts are facts; and although we may quote one to another with a chuckle the

words of the Wise Statesman, “Lies—damned lies—and statistics,” still there are some

easy figures the simplest must understand, and the astutest cannot wriggle out of.

Leonard Henry Courtney, To My Fellow Disciples at Saratoga Springs1

Over the last century, a steadily increasing flow of funds has been spent on cancer

research, both on the process of cancer and on treatments. This expenditure should

have produced an increasingly beneficial outcome for cancer patients. As scientific

knowledge has increased, as more and more drugs or other treatments are produced

as an outcome of this new knowledge, as more is learnt of cancer induction, one

might rationally expect that the diagnosis and treatment of cancer would have

become more effective and accessible, and that the rates of cancer incidence would

have declined.

In this chapter I will examine the statistics on both the incidence of cancer and

treatment outcomes for cancer patients. In particular I will examine:

Ü Whether research results over the last 100 years have given us lower rates of

cancer and better cure rates than at the end of the 19th century?

Ü What factors may influence any increase in cancer incidence?

Ü The introduction and use of the ‘5 year’ survival rate.

Ü Whether the death rate from cancer has decreased?

Ü Differences in cancer rates between industrialised and third world countries.

Ü Whether cause of death (autopsy) results correlate with what is written on

death certificates?

31


19th Century Death Toll from Tuberculosis

At the beginning of the 19th century, one-fifth of human mortality was caused by

tuberculosis. In cities such as London, with crowded living conditions, the rate was

even higher, often reaching 30%.

The death rate from tuberculosis steadily declined over the next 100 years. From

1812 until 1840, Boston, Philadelphia and New York recorded deaths of

approximately 400 per 100 000, although Budapest, in 1884, lost double this number.

By 1947, the death rate from tuberculosis in England was 69 (per 100 000), Canada

45.8 and the USA 41.3.2

Not only did the death rate decline, but there was also a change in the average age of

those affected by this disease. Where earlier the average mortality of males had

been in their 30s, by the early 1900s the disease was suffered more by the 50 to 60

age group. The only major increase in tuberculosis death occurred during both

World Wars I and II, particularly in those countries that were directly involved.3

We now, however, now experiencing a steady increase in the incidence of this

disease, mainly because of malnutrition and lack of hygiene. The increasing

resistance of bacteria to our armoury of antibiotics also heralds the return of infective

disease as a real danger for human health.

By the early years of the 20th century, as the incidence and death rate of tuberculosis

decreased, there came an awareness of the steadily increasing death toll from cancer

around the world.

20th Century Death Toll from Cancer

Escalation of Cancer to the Leading Cause of Death

According to H.W Keens (London, 1934):

...it appears that the earliest statistical record was made in 1838, and between that date

and 1850 the death-rate from cancer was so small per million people living (roughly 200

per mill.), that no great importance was attached to this, any more than to any other

disease having a similar death-rate.4

32


Increase of 245% in Cancer Deaths over 60 Years

The figures given in the Annual Returns of the Registrar-General for England and

Wales show that the ‘Mortality per Million Living’ for cancer for the years 1856–

1860 was 327. This figure steadily increased year by year and, by 1936, the

mortality rate per million was 1,625.5 This was an increase of 245% in the death rate

from cancer, over a 60 year period.

Australian Cancer Rates

In Australia, in 1921, the proportion of total deaths from cancer in males was 9.1%

and in females, 11.4%6. These figures steadily increased, and by 1988, deaths from

cancer were 25.3% in males and 25.2% in females.

By 1991, cancer became the principal cause of death for females in Australia. It had

already become the main cause of death for men a year earlier. Cancer has replaced

ischaemic heart disease as the primary cause for death in this country.

From 1960, following the introduction of the pap smear test, there was a steady

decline in the death rate from cervical cancer, but the age-standardised death rate

from breast cancer has shown minimal change from 1940 death rates—almost no

change in rates over the last 50 years.7

Future Predictions

This steadily increasing cancer rate is a global trend. According to a World Cancer

Report of 20038, published by the IARC (part of the World Health Organisation), the

global rates of cancer could increase by a further 50% to 15 million by 2020. The

report stresses the need to control this increase through the actions of governments

and health practitioners by the promotion of healthy lifestyles.

This WHO report estimates that one-third of cancers could be prevented by an

improvement in lifestyle—including the reduction of tobacco use, increased

consumption of fruit and vegetables, and increased physical activity—and by

providing screening programmes for such cancers where early treatment is known to

increase survival rates.

33


Demographics of Cancer Increase

Increase in Smoking-Related Cancers

Smoking has been shown to increase the risk of lung cancer by 20- to 30-fold. In

countries with elevated smoking levels, approximately 90% of lung cancers are

attributed to smoking. It is estimated that 50% of bladder and renal pelvis cancers

are from smoking, and cancers of the oral cavity, pharynx, larynx and squamous cell

carcinomas are also increased by tobacco use (as reported in the 2003 IARC World

Cancer Report).

Increase in Cancers Caused by Infection

The IARC report also documents a large variation in the incidence of cancers caused

by infection between developed and undeveloped countries. In developed countries,

approximately 8% of malignancies have infection as a cause; in undeveloped

countries, up to 23% of malignancies are from infectious agents. These infections

included Hepatitis B and C, Human Papilloma Virus and Helicobacter pylori.

Effect of Affluence on Survival Rates

Survival rates for cancer also differ between rich and poor countries. In affluent

countries, approximately 50% of cancer patients die of the disease, whereas in poorer

countries approximately 80% of patients die. Much—but not all—of this difference

reflects later diagnosis in the poorer countries.

Whether or not we presently have the best system of cancer treatment available to us,

our system is obviously more effective at prolonging life than treatments currently

available to the poor. The malnutrition suffered by the poor also contributes to a

lesser chance of surviving the disease.

There is however, an increase in the number of cancer cases in the developed world

as compared to the undeveloped. The developed nations show an earlier use of

tobacco, an earlier exposure to occupational carcinogens, and the Western lifestyle

and nutrition. Whereas the poor may receive little or no treatment and have minimal

nutrition with which to maintain health, our leisurely and well-fed society may be

killing many of us.

34


Increase in Hormonal Cancers

The incidence of hormonal cancers is increasing rapidly. World Health Organisation

estimates for 1997 rank breast cancer as the leading cancer, with a total incidence of

895,000, with 505,000 in the developed world and 390,000 in the developing

world.9

Measures of Success: The Death Rate

What are the crucial questions for a cancer patient? Death rate remains one of the

most important yardsticks by which to judge the success of cancer treatment.

However, quality of life of the cancer patient, which will be addressed in a later

section (see ‘Balancing Quality of Life Against Length of Life’ on page 247) is

equally important.

Death Rate Statistics

Australian Figures

In Australia, according to Australian Government Statistics, by 1995 there had been

a 4% increase in cancer death rate over the previous 20 years. 45% of all cancer

deaths were caused by cancers of the lung, colon, breast and prostate. The most

common causes of death were lung cancer (for men) and breast cancer (for

women).10

By 2002, the leading cause of death in Australia was cancer, with lung cancer and

prostate cancer having the highest incidence for men, and breast cancer followed by

lung cancer the highest for women.11

The figures, according to our Australian Bureau of Statistics, reflect an increase in

longevity causing an increase in cancer death, particularly in older men. However,

breast cancer, the leading cancer for women, tends more and more to be found in

younger women, and is therefore not attributable to increased longevity.

USA Figures

The 1950 US cancer death rate (for all types of cancer) was 194 out of 100,000

people. In 2001, 50 years (and billions of dollars of research funding) later, the death

35


rate per 100,000 people was 196. Any advance in treatment appears miniscule or

nonexistent.12

Cancer Deaths in the Third World

The difference in death rate from cancer between Western countries and the less

developed nations is startling. In Europe, 19% of deaths are attributed to cancer,

whereas in Africa, death from cancer is only 4%.13 There is no doubt that the rate of

cancer is much higher in developed versus third world countries. People in

developed countries live longer and are more likely to get cancer later in life, but the

higher rate has also been attributed to an increased use of tobacco in Western

countries. There is an expectation that, as tobacco use increases in developing

nations, so will the lung cancer rate increase.

Misclassification of Cancer Deaths

There appears to be an issue with the reporting of cancer mortality, which may

impact on the overall statistics of cancer death. Dr Gilbert Welch and Dr William

Black of Dartmouth Medical School have argued that cancer mortality may have

been underestimated by 0.9% in the USA, through the listing of the deaths of cancer

patients within a month of diagnosis and surgical treatment as attributable to ‘other

causes’.14

Welch and Black used data from the National Cancer Institute Surveillance,

Epidemiology and End Result (SEER) programme for 1994 to 1998. They examined

deaths not attributed to cancer in patients with 19 common tumour types who had

died within one month of diagnosis and had received cancer-directed surgery.

Their study showed that, of 4135 patients, 41% were not shown on their death

certificates as having died from cancer. These figures were broken down as follows:

Ü 42% of 1695 colorectal cancer patients,

Ü 34% of 525 lung cancer patients,

Ü 54% of 256 bladder cancer patients,

Ü 24% of 242 ovarian cancer patients, and

Ü 75% of 106 prostate cancer patients.

36


When the time period examined was extended to four months following diagnosis,

the undercounting of cancer deaths was elevated by a further 2%.

The inclusion of deaths such as these on the cancer registers would severely impact

on the apparent decrease in cancer mortality shown over the last decade.

Cancer Deaths Classified as ‘Other Causes’

How does this ‘undercounting’ or ‘misclassification’ of cause of death occur?

Studies of mortality rates taken from the NCI Surveillance, Epidemiology and End

Result (SEER) programme, over the period 1973 to 1987, showed that out of 913,161

cancer patients, 40% were recorded as having died from cancer and 21.4% as having

died of ‘other causes’.

The most common cause of death for the 21.4% of patients who had died of ‘other

causes’ was: circulatory malfunction (i.e. acute myocardial infarction, chronic

ischemic heart disease, cerebrovascular disease, cardiovascular disease, cardiac arrest

and congestive heart failure) and respiratory disease (i.e. chronic airway obstruction,

pneumonia and emphysema). It is unlikely that without the cancer and its

subsequent treatment, these patients would have died of these conditions.

Deaths from Cancer Treatments

Many of the above conditions, resulting in ‘other causes’ of death, may be associated

with certain cancers, but they are also definitely associated with cancer treatments

such as chemotherapy or radiotherapy.

When cancer patients who died from ‘other’ causes were compared with known age-

and sex-specific mortality figures (Population Hazard Rates), it was found that the

overall non-cancer death rate was 1.37 times higher than expected for US age- and

sex-specific mortality figures. These figures were garnered from a study of cancer

patients diagnosed between 1973 and 1987. If these deaths were attributed to cancer,

then the cancer death count would increase by 7.4%.15 This strongly suggests an

increase in death from the effects of treatment; this potential increase is discussed

further on page 41.

37


Disagreement Between Diagnosis and Autopsy Results

Another factor that gives a false (decreased) figure for cancer death rate is the

misdiagnosis of cancer and false reporting on the death certificate. The regular use

of autopsy as a check of cause of death has become a thing of the past. Most death

certificates are now filled in by the attending physician without further verification of

cause. Figures from the USA in 1998 put the number of autopsies at below 9% of

deaths,16 with autopsies of nursing home deaths being only 0.1 to 1.0%.17

The track record of agreement between diagnosis and autopsy results has been rather

poor, judging by published papers. In 1974, the concordance between the ‘gold

standard’—the autopsy—and medical judgement was only 43%.18 This was an

improvement on the 35% correlation achieved in 193819. However, with the vast

changes in laboratory assay ability, equipment for scanning, and DNA technology,

one would expect that diagnostic ability would have dramatically increased.

Unfortunately, the statistics do not support this.

By 1983, the correlation between diagnosis and autopsy had improved to 47%20. As

the following two studies show, one could generously say that by 2003 there had

been no change.

In 1998 in the USA, when 1105 cases were reviewed by autopsy, the discordance

between diagnosis and autopsy findings was 44%. The study showed that 111

malignant neoplasms had been either undiagnosed or misdiagnosed, and that 57

deaths were directly attributable to cancer without this appearing on the death

certificates.21

Another similar study over a 10-year period found that the clinical diagnosis had

been correct in only 40% of cases.22 Figures from Japan indicate that more than 10%

of malignant neoplasms are either misdiagnosed or undiagnosed despite medical

investigations.23 When death certificates and autopsy results at an academic

institute, Vermont USA, were compared it was found that, of 50 death certificates

reviewed, 17 (34%) had a wrong cause or manner of death listed and 82% showed

multiple errors.24

38


If all deaths were to be autopsied, these papers suggest that the recorded cancer death

rate would be increased to frightening levels.

Are Published Figures Correct?

Are the published figures on both the incidence and mortality of cancer generally

agreed and accepted? Obviously the research scientists who carried out the studies

on death rates mentioned above would dispute the published statistics.

There may never be total truth in the production of statistics. The belief and attitudes

of those compiling the data must have an influence on the way that data is viewed

and presented both to patients and clinicians. Compiling data to reflect a ‘best case

scenario’ occurs in many fields of science. The use of the 5-year survival time is an

example of this.

Measures of Success: ‘5-Year’ Survival Rate

The 5-year survival rate is commonly used as a measure of success of treatment and

this has enormous effects on patient longevity statistics. It was originally intended

not to be an end point but rather a point sufficiently removed from original treatment

to allow conclusions as to efficacy of treatment regimes (Sutherland quoting

Hawkins).25

When patients are followed for longer time frames, the statistics generally quoted

begin to seem rather irrelevant. According to Sutherland in Cancer: Significance of

Delay, a 1926 study by Moshcowitz et al showed that a survival rate of 34% at 5

years became 31% at 6 years, 26% at 7 years, and by 10 years from treatment only

4% of patients were still living.

In 1947, Finney, Merkel and Millar followed 298 breast cancer patients. This group

of women at the 5-year point had 49% survival, but 15 years from initial treatments

again only 4% were still living.26 Neither of these two early studies on longevity

stated the age groups of patients followed, so it is difficult to know if the results

given were age-standardised. Later papers are more inclined to use age-standardised

figures.

39


An assessment of age-adjusted mortality rates for the period 1970 to 1994 in the

USA showed that cancer mortality for 1994 (200.9 per 100,000) was 6.0% higher

than the rate for 1970 (189.6 per 100,000).27

Haydn Bush, in a 1984 article in Science, stated:

If you take a close look at the statistics on cancer cures, it soon becomes apparent that

we’re not curing much more cancer than we were a generation ago. The death rates on

the whole just haven’t changed significantly...

... There has been very little progress on the biggest cancer killers of the last 25 years—

cancer of the lung, the breast, the colon, and the prostate. The death rate has not declined

appreciably for any of these, and for lung cancer it has actually risen. Of all the more

common forms of cancer, death rates for only two have declined substantially in recent

decades—stomach cancer and uterine cancer.28

In fact, a 1978 examination of cancer statistics by Hardin Jones, Professor of Medical

Physics at the University of California, led him to state:

My studies have proven conclusively that untreated cancer victims live up to four times

longer than treated individuals.29

When cancer patients discuss their treatment with their practitioners, statistics are

invariably quoted relating to 5-year survival rather than longevity outcome studies.

Certainly, figures for 5-year survival are more encouraging to patients faced with the

possibility of debilitating treatment regimes than studies such as those mentioned

above, but it creates an illusion of success of treatment that is not supported by

current statistics.

An article, published on 12 December 2001 in the Medical Observer Weekly titled

Australia has highest cancer survival rates30, states that the cancer death rates are

continuing to fall. It cites survival improvements in breast cancer, Hodgkin’s

disease, kidney and colorectal cancer, cervical and prostate cancer. All

improvements stated are based on 5-year survival rate rather than death rates or

longevity rates for each cancer.

40


Are Treatments Increasing Cancer Statistics?

Chemotherapy Drugs As Carcinogens

An examination of the Hazardous Substance Fact Sheets31 for chemicals lists the

following chemotherapy drugs as carcinogens:

Ü Dactinomycin (Actinomycin D): Used in the treatment of testicular, ovarian,

germ cell cancers and osteosarcoma.

Ü Adriamycin (Doxorubicin): Used in the treatment of non-Hodgkin’s

lymphoma, multiple myeloma, acute leukaemias, breast, adrenal cortex,

endometrium, lung, ovary, bone cancer and rhabdomyosarcomas.

Ü Cisplatin: Used in the treatment of testicular, ovarian, lung, bone, cervical

and mesothelioma.

Ü Cyclophosphamide: Used in the treatment of lymphoma, leukaemias,

multiple myeloma, mycosis fungoides, neuroblastoma, retinoblastoma, breast,

ovary, rhabdomyosarcoma, bone cancer and childhood non-Hodgkin’s

lymphoma.

Ü Daunorubicin (Daunomycin): Used in the treatment of acute lymphocytic

and myelocytic leukaemias.

This is a very small selection of the chemotoxic drugs available in oncology.

Furthermore their cancer-inducing properties are not the only side effects caused by

these drugs. Information on the use of these chemotoxic drugs is taken from the

American Cancer Society web site at http://www.cancer.org/docroot/home/index.asp.

I do not wish to imply that all chemotherapy drugs are carcinogens, but I have not, to

date, found any chemotherapy drug that has been listed as having no side-effects.

Induction of a future cancer is certainly a most serious side-effect and one about

which most cancer patients appear to be unaware.

Radiotherapy As a Carcinogen

The other main stay of cancer therapy—radiotherapy—is also known to potentially

induce cancer.

41


Radiation treatment for prostate cancer has been linked to a 70% increase in rectal

cancer. As there was no noticeable increase in other cancers in the colon, the effect

appeared to be limited to tissue that received direct irradiation.32 As more than half

of cancer patients treated, receive radiotherapy as part of their treatment, and as

current treatment now uses intensity-modulated radiation therapy, (IMRT), which

involves a larger volume of normal tissue being exposed to lower doses of radiation,

this increases the risk of second cancers at a later date.33

Conclusions

Over this last century the figures do not appear to support any major improvement

for cancer patients as far as real cure is concerned. Not only are we seeing

enormous increases in the incidence of cancer world-wide, but there is only a very

minimal improvement in the long-term survival rates for patients diagnosed with

cancer.

Any industry that has spent enormous amounts of money on cancer research that has

given such poor results would have problems maintaining the illusion that the money

has been well spent. Yet rather than seeing a shift in focus away from the relatively

ineffective treatments (many of which have not changed over the last three quarters

of the century) we have seen only a continuous repetition of the same. Despite the

many calls for more funding to go to prevention, support for this remains minimal

when compared to funding for research into new drugs for treatment (see Chapter 6,

Following the Money).

42

1 Courtney LH (1895), 'To My Fellow Disciples at Saratoga Springs', The National Review, 26: 21-26.

2 McCormick WJ (1947), 'The Changing Incidence and Mortality of Infectious Disease in Relation to

Change in Trends in Nutrition', Lee Foundation for Nutritional Research: 1-9.

3 ibid.

4 Keens HW (1934), 'Annual Returns', Medical World.

5 Bayly MB (1938), 'Cancer - The Failure of Modern Research, A Survey', The Health Education and

Research Council, London, UK.


43

6 d'Espaignet ET, vanOmmeren M, Taylor F, Briscoe N & Pentony P (1991), 'Trends in Australian

Mortality', Mortality Series No 1, Australian Institute of Health, p33.

7 Madden R (1994), 'Women's Health', Australian Bureau of Statistics, 4365.0: Ch 2: Mortality.

8 Kleihues P (2003), 'Global Cancer Rates could increase by 50% to 15 million by 2020', World

Health Organisation, 3 April.

9 Sasco AJ (2002), 'Taking an International Look at Breast Cancer Statistics', 2nd World Breast

Cancer Conference, Victoria, Canada.

10 Jelfs P, Giles G, Shugg D, Taylor R, Roder D, Fitzgerald P, Ring I & Condon J (1994), 'Cancer in

Australia 1986-1988', Australian Institute of Health and Welfare, Australasian Association of Cancer

Registries, p5-6.

11 (2005), '1995 Health - Causes of Death: Cancer Trends', Australian Social Trends, Australian

Bureau of Statistics, 16 September 2003.

12 Bartlett DL & Steele JB (2004), Critical Condition, Doubleday, New York, NY, 52.

13 (2005), 'Growing Ageing Population Drives Global Cancer Rise', Medical News Today, London, 2

May 2005.

14 Welch G & Black W (2002), 'Are Deaths Within 1 Month of Cancer-Directed Surgery Attributed to

Cancer?' Journal of the National Cancer Institute 94(14): 1066-70.

15 Brown BW, Brauner C & Minnotte MC (1993), 'Noncancer Deaths in White Adult Cancer Patients',

Journal of the National Cancer Institute 85(12): 979-87.

16 Lundberg GD (1998), 'Low-Tech Autopsies in the Era of High-Tech Medicine', The Journal of the

American Medical Association 280: 1273-74.

17 Mitka M (1998), 'Unacceptable nursing home deaths unautopsied', The Journal of the American

Medical Association 280: 1038-39.

18 Britton M (1974), 'Diagnostic errors discovered at autopsy', Acta Medica Scandinavica 196: 203-

10.

19 Bean WB (1938), 'Infarction of the heart', Annals of Internal Medicine 11: 2086-108.

20 Zarling EG, Sexton H & Milnor P Jr (1983), 'Failure to diagnose acute myocardial infarction', The

Journal of the American Medical Association 250: 1177-81.

21 Burton EC, Troxclair DA & Newman WP (1998), 'Autopsy diagnoses of malignant neoplasms: how

often are clinical diagnoses incorrect?' The Journal of the American Medical Association 280(14):

1245-8.

22 Ornelas-Aguirre JM (2003), 'Concordance between premortem and postmortem diagnosis in the

autopsy; results of a 10-year study in a tertiary care centre', Annals of Diagnostic Pathology 7(4): 223-

30.

23 Inoue K, Yoshioka K & Kawahito Y (1999), 'Is the Discordance Rate of Malignancy Still High?'

Archives of Internal Medicine 159(9): 1013.

24 Pritt BS, Hardin NJ, Richmond JA & Shapiro SL (2005), 'Death certification errors at an academic

institution', Archives of Pathology & Laboratory Medicine 129(11): 1476-79.

25 Sutherland R (1960), Cancer: The Significance of Delay, Butterworth & Co Ltd, London, UK.


44

26

ibid., p15.

27 Bailar JC III & Gornik HL (1997), 'Cancer Undefeated', The New England Journal of Medicine

336(22): 1569 -74.

28 Bush H (1984), 'Cancer: The New Synthesis', Science 84: American Association for the

Advancement of Science, September 1984: 28-39.

29 Beasley JD & Swift JJ (1989), The Kellogg Report: The Impact of Nutrition, Environment &

Lifestyle on the Health of Americans, The Bard College Center, The Institute of Health Policy and

Practice, New York, 7E: 341.

30 (2001), 'Australia Has Highest Cancer Survival Rates', Medical Observer Weekly, viewed 1 April

2006, <http://www.mydr.com.au/>.

31 (2000), 'Occupational Health Service: Hazardous Substance Fact Sheets', New Jersey Department of

Health and Senior Services, viewed 1 April 2006, <http://web.doh.state.nj.us/rtkhsfs/indexfs.aspx>.

32 (2005), 'Prostate Radiotherapy Raises Risk of Rectal Cancer', Reuters, viewed 1 April 2006,

<http://www.integrarx.com/news/index>.

33 Hall EJ (2004), 'Henry S. Kaplan distinguished Scientist Award 2003 - The crooked shall be made

straight; dose-response relationships for carcinogenesis', International Journal of Radiation Biology

80(5): 327-37.


PART II

RESEARCH FINDINGS

45

Changes in Cancer Research: Research Findings, Economics, Philosophy Jennie Burke – April 2007 Chapter 3 – History of Cancer Research: Cause and Treatment

Chapter 3

History of Cancer Research: Cause and Treatment

Cancer is not a new disease for humanity but it does appear to have more impact

today. This is because of our increased life expectancy, an emphasis on anti-aging

medicine and greater exposure in the media. As shown in Chapter 2, A Century of

Cancer Statistics, the overall rate of cancer in the populations of Western countries

has steadily increased in recent decades.

Accumulated knowledge about the causes of cancer and the cellular changes that

occur in cancerous growth has also steadily increased. Changes in the treatment of

cancer have sometimes, but not always, followed these newer concepts and

understanding of cancer. Are research findings and patient outcomes of treatment

the only—or even the major—factors in the direction that cancer research and

treatment has taken?

Cancer research during the 20th century appears to have followed two streams:

prioritised ‘conventional’ research, and the neglected, unconventional cancer

research. The latter is available to those who search for it, but it has not been given

its due place in the literature. This less known research is discussed in Chapter 5,

Paths Not Followed.

In this chapter, I present findings from the ‘conventional’ cancer research over the

last century. The mainstays of cancer treatment over the 20th century have been the

use of surgery, chemotherapy and radiotherapy. Only a brief history of these

treatment modalities and the results achieved by them is presented.

Of particular importance is the research that has not been done—omissions in

follow-up research on causes or oncogenesis, and in the research of other potential

treatments—and on the many reasons for these omissions.

46


Early Cancer Research

Cancer has probably always existed. The word comes from the Ancient Greek:

Karcinos, meaning the crab. Tumours have been found in dinosaurs from the

Cretaceous Age, and mummies from 3000 to 2500 BC in of Egypt have shown signs

of cancers. A 1600 BC papyrus discussed surgery as a treatment for cancer.1

The following is a basic outline of the history of changes and additions to the

knowledge of cancer causation within conventional medicine.

Earliest Mentions of Tumours: Humors or Black Bile

European literature from the 6th century began to regularly refer to the classification

and treatment of cancer. Hippocratic medicine had introduced the concept of

‘humors’ and, within this framework, cancer was considered to be caused by the

accumulation of the melancholic humor, black bile.

The Roman physician Galen of Perganum (129–199AD) was the author of the only

text from antiquity specifically devoted to tumours: De tumoribus praeter naturam.

It followed the Hippocratic teaching of humors, but specified that cancer is caused

not just by an excess of black bile but by a cool, black bile. Galen’s teachings were

followed2 until the discovery of the lymphatic system in humans by Thomas

Bartholin in 1652.3

Galen’s beliefs were held for almost 2000 years. One of the earliest known

antagonists to Galen’s teachings was Dr Andreas Vesalius, who in 1543 published

findings from his studies and dissections in De Humani Corporis Fabrica. Vesalius

challenged the political, social, academic and church forces of the day, causing such

a controversy that he was eventually forced to resign from the University of Padua in

Italy.4

18th Century: Tissue Capable of Destructive Growth

The next major deviation from Galen’s teaching was by Deshaies Gendron of Italy in

1700. Through observation of cancerous cases, Gendron noted that the growths were

not inflammations caused by ‘humors’ but rather were composed of “nervous,

glandular and lymphatic vascular parts … capable of destructive growth.”5

47


Gendon’s views, however, did not change the dominant thinking within the

profession—the chirgeons and physicians of the day.

19th Century: Tumours Derived from Normal Cells

Research during the 19th century into causes of cell proliferation leapt ahead with the

work of Dr Rudolph Virchow, now referred to as the father of cellular pathology for

his use of the microscope. Virchow was a student of the German pathologist

Johannes Muller, who had found that tumours were composed of cellular tissue and

not the ‘lymph’ as was previously thought. It was Virchow who proposed that

chronic irritation was the likely cause of cancer. This belief carried through into the

20th century.6

Cancer from Normal Tissue, Metastasis via Blood or Lymph

Two papers by Wilhelm Waldeyer, published in 1867, laid the foundations for an

approach to cancer theory that is still in use today. These papers stated that: 7

Ü Cancers develop from normal tissue that grew and multiplied through cell

division.

Ü Cancers can spread throughout a local region by the movement of cancer cells

into adjacent tissue.

Ü Metastatic spread of cancer is caused by cancerous cells moving through the

lymphatic system and/or the blood to distant sites.

These were the prevailing theories in oncology until the environmental and genetic

causes of cancer were discovered in the mid 20th century.

1920s: Respiration in Cancer Cells

In the 1920s, Dr Otto Warburg studied glycolysis in tumours. He found that cancer

cells show variations to their respiratory mechanisms, with an increase in lactic acid

production, which he felt was involved in the neoplastic transformation of cells.

Warburg’s theories became a central part of later treatments that used ozone and

hydrogen peroxide to affect cell respiration.

48


The American Cancer Society web site states that these therapies, based on

Warburg’s theories, have now been discredited.8

1928: Dismissal of Theory of Causal Parasite in Cancer

In a lecture given at the International Conference on Cancer in 1928, Dr James

Ewing, an influential American pathologist, stated:

The theory of a universal cancer parasite stimulating the cell to incessant growth is the

most popular explanation of the cancer process, and seems to satisfy many minds. It

must be ruled out of court on the ground of no evidence. It raises more questions than it

solves, and is inconsistent with the known facts about many tumours.9

Ewing had written a widely used textbook, Neoplastic Disease, in which he noted:

“few competent observers consider the parasitic theory as a possible explanation in

cancer”. This signalled a halt to most research into this area of cancer cause.10

Epidemiology of Cancer

The pioneer of observational epidemiology was Percival Pott (1714–1788), who

proposed that the high rate of scrotal cancers in London chimney sweeps was caused

by soot accumulating in the folds of the scrotum.11 With this observation, Pott gave

birth to the field of occupational health.

In 1915, researchers in Japan found that cancer could be induced in laboratory

animals by the application of coal tar to the skin, and this led to further studies of the

environmental causes of cancer.12

Early Recognition of Tobacco As a Causal Agent

Tobacco was first queried as a cause of cancer in the mid 19th century by clinician

John Hill, a query that was scientifically justified 150 years later.13

Lung cancer was not a common cancer prior to the 20th century. In a publication on

malignant growths of the lung and bronchi, Adler questioned, “Is it worthwhile to

write a monograph on primary malignant tumours of the lung?”.14 Differentiating

between lung carcinomas and other diseases such as tuberculosis and pulmonary

49


disease was difficult, and the consensus of opinion was that primary malignant

neoplasms of the lungs were rare.

The first statistical evidence of the link between lung cancer and smoking was

published in 1929 by Fritz Lickint of Dresden15.

In 1939, the German researcher Dr F. Muller published the paper Tabakmissbrauch

und Lungencarcinom in the Zeitschrift fűr Krebsforschung, in which he provided

clear evidence of the link between smoking and lung cancer.16

1950s: Epidemiological Studies of Smokers

By the 1950s, many epidemiological studies were investigating this link. The

American Cancer Society funded one of the largest studies (beginning in 1959), in

which around one million men and women answered questions about age, diseases

and smoking histories. Questionnaires were updated every four years or so, and a

death certificate was supplied when a participant died.

After about 12 years, the results showed that “the Standard Mortality Ratio from lung

cancer increased dramatically with the number of cigarettes smoked and with the

inhalation of smoke.” It was also found that the Standard Mortality Ratio for ex-

smokers decreased as the time since quitting increased.17

Enzymatic Studies of Cancers

The 1950s also saw the beginning of work on the enzymatic activity of neoplasms.

This eventually led to the ‘convergence hypothesis’ of Dr J.P. Greenstein, whose

experimentation suggested that cancer cells showed increases in their metabolic

pathways.18 It was subsequently found that such increased pathways were common

to many forms of cancers, but not to all.

50


Genetic Studies of Cancer

Gene Repression from Oncogenic Agents

Dr V.R. Potter, in the 1960s, proposed that the proteins lost during carcinogenesis

were vital for controlling the enzyme systems involved in cell division. He proposed

that:

Repressors, crucial to the regulation of genes involved in cell proliferation are lost or

inactivated by the action of oncogenic agents on the cell, either by interacting with DNA

to block repressor gene transcription or by reacting directly with repressor proteins and

inactivating them.

Once repressor gene transcription is blocked, cell regulation is lost, and

proliferation may begin.19

DNA and Genome Mapping

The discoveries of Watson and Crick have driven the direction of cancer research

through the middle to late 20th century. The discovery of DNA, and the later

mapping of the human genome, opened up numerous possibilities for cancer

researchers. Some earlier theories of cancer cause were validated by this work. For

example in 1914, Boveri had published Zur frage der erstehung maligner tumoren,

describing how a “wrongly combined chromosome complex” might cause abnormal

cell proliferation in somatic cells.20

Discovery of the Breast Cancer Gene BRCA 1

The new science of molecular genetics gained an enormous boost with the search and

discovery of a gene associated with breast cancer. In 1986, Mary-Claire King found

a mutation on a particular gene (called BRCA 1) in her study group of women with

breast cancer. The evidence for this had taken Dr King 15 years to accumulate.

In 1984, a special edition of the Journal of the American Association for the

Advancement of Science (AAAS) was published, titled The Making of a Cell:

Cause—Cure—Prevention. On the opening page, editor Allen L. Hammond

acknowledged the great discoveries in cancer in the previous two years, but also

admitted that:

51


People with the leading kinds of cancer are no more likely to survive than they were a

generation ago. The best way to treat cancer, in this emerging view, is not to get it in the

first place.

The first article, Cancer: the New Synthesis, was written by senior editor Boyce

Rensberger with the aid of researchers from the National Cancer Institute, Drs Harry

Gelboin and Stuart Yuspa. Here they argued that the common mechanisms of cancer

causation are chemical carcinogenesis, radiation, viruses and chromosomal

rearrangements.21

Recognition of Viruses as a Causal Agent

That various chemicals and radiation could induce cancer has been known for many

years, and the new era of DNA work has shown that mutations of chromosomes is

also a potential cause. There has been persistent opposition, however, to the idea of

cancer being caused by an infective agent.

The AAAS journal special edition (discussed above) included an interview with Dr

Stuart A. Aaronson of the National Cancer Institute, a geneticist who had isolated a

virus that was capable of causing cancer in monkeys. He speculated that this virus

transferred growth-factor-like genes to the host cells, causing the cells to begin an

endless proliferation.

In this article, the author(s) noted that “Most researchers believe that viruses are not a

major cause of human cancer”22, hence the paucity of research into infective agents

as potential carcinogens.

A Century of Chemotherapy Treatment

Chemical poisons to treat cancer have been investigated and used since the sinking of

the John Harvey, a Liberty ship, in the harbour at Bari, Italy on 2 December 1943.

The John Harvey, which contained 2000 mustard gas bombs in its holds when it was

bombed, had released this poison into the water. The survivors of other bombed

ships were plunged into the water and broke out with skin irritations and ulcers.

After several days, an expert in chemical warfare, Lt. Col. Stewart Alexander,

52


noticed that their white cell counts were decreasing rapidly and they were becoming

anaemic.23

This observation, in combination with earlier investigations into bone marrow aplasia

due to mustard gas exposure during the First World War, led to its initial use in the

treatment of lymphoma.24

The First Chemotherapy Drugs

In 1946, Cornelius Rhoads derived the first alkylating compound from nitrogen

mustard. Over the next 20 years a series of similar drugs were produced.

In 1948, Seymour Farber found that folic acid could disrupt cancer cell metabolism.

This is still used in treatments of leukaemia and certain other cancers.25

In 1954, the forerunner of the National Cancer Institute was established in Bethesda.

Here Charles Huggins experimented with hormones in cancer treatment; George

Hitchings developed purines and pyrimidines that interfere with cell metabolism;

Charles Heidelberger developed fluorinated compounds; and Alexander Haddow

experimented with urethane and other compounds.

Chemotherapy—the use of cytotoxic agents—became a standard treatment in

advanced Hodgkin’s disease26, disseminated testicular cancer27, and as an adjunct

treatment of breast cancer28.

Chemotherapy Usage

Chemotherapy usage is intended to supply enough of the drug to eradicate the cancer

without causing irreversible toxicity in the patient. The border between unacceptable

toxicity and benefit varies from one patient to another, and is subject to a diverse

range of co-factor relationships.

Commonly, a combination of chemotoxic drugs is administered. Each drug differs in

its toxic side effects and in the type of damage it causes to the tumour, with the aim

of making the tumour more susceptible and less likely to develop resistance to the

53


drug regime. However, some patients sadly still succumb to the toxicity of their

treatment regime.29

Newer Treatments

Newer treatments such as monoclonal antibodies are now used to direct

chemotherapy drugs directly to the tumour. Biological agents such as interferons,

interleukins and other cytokines are used to influence the natural immune response,

altering the growth of cancer cells and aiding healthy cells in controlling tumour

growth.30

The ‘Magic Bullet’

The idea of the ‘magic bullet’—miracle medicine—began during World War II, with

the use of antibiotics in managing battle wounds. The use of penicillin, morphine

and sulphur drugs became wide spread, and the concept of high-technology cures

was introduced into the public mindset.31

A Century of Radiotherapy

In 1895, X-rays were discovered by Wilhelm Conrad Röntgen in Würzburg,

Germany. The same year saw the initial therapeutic attempt to use X-rays to treat a

relapse of a breast carcinoma. In 1896, X-Rays were used by Victor Despeignes in

Lyons to treat stomach cancer, and by Léopold Freund in Vienna to treat a skin

tumour.

In 1898, Pierre and Marie Curie discovered radium. This was first used

therapeutically for skin ‘brachytherapy’ at the Hôpital Saint-Louis by Dr Danlos in

Paris. By 1934 Marie Curie had tragically died from pernicious anaemia, induced by

exposure to the radium she had worked on.32

First Clinical Uses

Charged-particle beams were first proposed for clinical use in 1946 by Wilson, and

first used to treat human cancer patients in Uppsala, Sweden, by Leksell and Larsson.

John Lawrence, in 1954, used the Berkeley cyclotron to irradiate the pituitary glands

of patients with metastatic breast cancer, in an attempt to achieve hormonal

54


suppression (Tatter quoting Tobias33.) Lawrence used protons in this way to treat the

first 30 patients, but later patients were treated using helium ions.

Research into Heavy Particles

Research has continued into the use of heavy particles other than protons, such as

neutrons, carbon and neon light ions and pi mesons. Research has not been

successful with pi mesons, but the other particles continue to be examined as they all

exhibit different biological effects on cells. Unlike X-Rays, protons deliver a

radiation dose up to— but not beyond —an energy-dependent depth.

Utilising Radiation Damage to Cells

Radiation causes immense damage to cells, and secondary electrons create an

increase in free radicals in the intracellular material. These radicals can chemically

induce breaks in DNA, causing both malignant and normal cells to die.

There is a small difference between the radiation response of normal and malignant

cells. Although this differential response is not fully understood, it allows for normal

tissue to be preserved while the tumour, and tissue in close proximity, is targeted.34

New Radiation Regimes

New regimes such as ‘external beam radiotherapy’ are used for pain control, and

they have replaced the older prolonged courses of radiotherapy35. Strontium–89 and

Samarium–153 are radioisotopes and radiopharmaceutical products, now widely used

to reduce pain in cases of sclerotic bone metastases, breast cancer and prostate

cancer.36 37

A Century of Surgery

Prior to the discovery of anaesthesia, surgical procedures were grotesquely painful

events that often caused death from shock and blood loss. With the advent of the use

of nitrous oxide as anaesthesia by Horace Wells in 1848, surgery became—and has

remained—a mainstay of medical treatment for many cancers.38

55


Radical Mastectomy

Radical mastectomy was developed at Johns Hopkins University by Professor

William Halsted in the 1890s. Halsted believed that removal of the tumour was

curative and that the appearance of any future tumours were the result of a new

cancer. The radical mastectomy remained the standard medical treatment for breast

cancer for almost a century.39

Modern Surgery

Modern surgery is often combined with radiation therapy or chemotherapy, and is

undoubtedly less disabling than earlier radical procedures. Newer techniques, such

as cryosurgery or cryoablation, are being studied as potential treatments for some

forms of localised cancers.40

Success Dependent on Surgeon’s Skill

The ability of the surgeon has been shown to influence the nature of the outcome for

the patient, as measured in increased survival times.41 Variations in survival rates in

ovarian cancer patients have been found to be dependent on whether surgery was

performed by general surgeons or by gynaecologists.

In one study, median survival time for patients operated on by general surgeons was

9.87 months, as compared to a median survival time of 29.1 months for patients of

gynaecologists, i.e. three times as long.42 The ability of the surgeon is undoubtedly

of gravest importance to the life span of the patient.

Forms of Surgery

There are eight primary forms of surgery:

Ü Radical,

Ü Limited,

Ü Tumour reduction,

Ü Evaluation,

Ü Relapse and metastasis,

Ü Palliative,

Ü Reconstruction, and

56


Ü Pain reduction.43

Results of Research

Losing the War on Cancer

In 1986, John Bailar III, Professor of epidemiology and biostatistics at McGill

University, published a lack-of-progress report on President Nixon’s ‘War on

Cancer’. Later in 1994, he concluded—from data provided by the National Cancer

Institute—that the US cancer death rate had increased by 7% between 1975 and

1990, i.e. the war appeared to have been lost. This increase did not reflect aging of

the population; it reflected increasing death rates from cancers such as non-

Hodgkin’s lymphoma, multiple myeloma and cancers of the prostate, brain, kidney,

oesophagus and breast.44

Epithelial Cancers Increasing and Difficult to Treat

The most common cancers are the epithelial cancers: breast, ovarian, lung, prostate

and colorectal. These cancers are increasing in occurrence and are often the most

difficult to treat, advanced cases responding relatively poorly to chemotoxic

treatments. Ovarian cancer shows some response to chemotherapy, but therapeutic

benefit for the other epithelial cancers is very limited. Response to therapy (i.e.

tumour shrinkage) in these patients does not indicate prolonged survival.45 Less

aggressive treatment is often as effective as the standard, more aggressive regimes.

Chemotoxic Agents Have Little Impact on Most Common Cancers

Chemotherapy has become one of the major treatments for cancer over recent

decades. The debate on whether this increase in usage is justified has continued in

the medical literature for almost as long.

A large amount of chemotherapy is being prescribed with a palliative intent, not just

in the hope of cure. Few studies on the effectiveness of chemotherapy have

produced data that supports palliative use. Kearsley (1986) examined the impact of

cytotoxic chemotherapy on the most common adult malignancies and produced the

following chart showing the estimated number of people who benefit from

chemotherapy in the USA.46

57


2.54% (

3.18% (25,000)

35.6% (280,000) With

inoperable disease or

metastases at presentation

41% (321,850) Cured by

local treatment alone:

Surgery (219,850) 28%

Radiotherapy (90,000) 11.46%

Chemotherapy (12000) 1.52%

Achieve appreciable

prolongation of life (>2 years)

23.4% (183,150) With

recurrence after 1.78% (14,000) With

local treatmentmetastases cured by

chemotherapy alone

20,00

juvan

0) Cured as a

result of ad t chemotherapy

re 3-1: Success Rates for Chemotherapy, Radiotherapy and Surgery

n 19 al review of the benefit of chemotherapy for epithelial cancer was

m the Institute of Epidemiology and Biometrix in

ce for

creased survival through cytotoxic therapy in some of the common epithelial

tumours.47

Table 3-1: Direct evidence from ra ndomised studies on the question of

whether pr

Chemotherapy + X X alone(X = any tr )

Immediate vs deferred therapy

Dose-effect studies

Figu

I 92, a critic

published by Ulrich Abel, fro

Germany. In the following tables, he summarises the direct and indirect eviden

in

palliative chemotherapy olongs survival

Site vseatment

Lung, small-cell + Ø -

Lung, non-small cell (+) - Ø

Colon/Rectum Ø unclear Ø

Stomach - Ø

Pancreas - Ø Ø

Bladder Ø Ø Ø

Breast - (-) -

Ovary Ø Ø unclear

Cervix Uteri Ø Ø -

Endometrium Ø Ø Ø

58


59

of (+) the effect is, if any, small.

Ø: There is no evidence of this type

+ or -: The evidence is definitely positive (negative, response)

(+) or (-): Unclear evidence, on the whole rather positive/negative. In case

Table 3-2: Indirect evidence on the question of

whether palliative chemotherapy prolongs survival.

Site Randomised comparisons of different regimens

Non-randomised comparisons of patient cohorts

Lung, small-cell + -

Lung, non-small cell unclear -

Colon/Rectum - -

Stomach - -

Pancreas - -

Bladder - -

Breast (-) -

Ovary + -

Cervix Uteri - -

Endometrium - -

Explanatory notes: see Table 3-1.

Abel states that there is (as of 1992) no clear evidence that chemotherapy improves

the quality of life of cancer patients, a rationale often used for offering

hemotherapy. He concludes the article, writing that:

de

nts, does not point to a use of therapy which is particularly geared to patients’ well-

being.

adult

-year survivals. The

ials included in the study were from 1990 to 2004.

juvant cytotoxic

chemotherapy to 5-year survival was 2.3% in Australia and 2.1% in the USA.

c

It should arouse concern, however, that according to opinion polls, many oncologists

would decline to accept cytotoxic therapy in their own case. Also, the observation ma

by Holli et al on 252 patients with advanced breast cancer that the “risk” of receiving

cytotoxic therapy was three times as high in the terminal stage as in the remainder of the

patie

A review of randomised clinical trials on 5-year survival—with the benefit

attributable only to chemotoxic therapy—was published recently by Morgan et al

(2004). The authors conducted a systematic review or meta-analysis of trials in

malignancies that reported statistically significant increases in 5

tr

The conclusion reached was that the contribution of curative or ad


60

colorectal, breast,

ies—Kearsley (1986), Abels (1992) and Morgan (2004)—show

inimal change in the efficacy of chemotherapy over 21 years.

may explain the above lack of long-term

otherapy. In 2003, Al-Hajj et al isolated and identified cancer stem

49

nce to

ay accumulate more mutagens than more mature cells with shorter

n normal

ve

When individual malignancies were studied it was found that

prostate, melanoma and lung cancer—the most common cancers that account for

56% of the total cancer incidence in Australia—showed a benefit of only 1.6% in

1998.

The less common cancers, such as Hodgkin’s disease, non-Hodgkin’s lymphoma,

and cancers of the cervix, ovary and testis—that account for only 8.4% of cases in

Australia—remain the most sensitive to chemotoxic agents and gave a benefit of

14%.48 The conclusion reached by Morgan et al was that the newer drugs and

combination regimes have had little impact on survival times.

The three stud

m

A New Paradigm—Understanding Therapeutic Resistance

A new theory has been proposed, which

benefit with chem

cells from a primary human breast cancer.

Cancer stem cells, although comprising only 1% to 2% of the total tumour mass,

have a greater proliferative potential than more differentiated cancer cells. Cancer

stem cells possess many of the same characteristics as normal stem cells, i.e. the

ability to self-renew, to produce differentiated progeny and to exhibit resista

DNA damaging agents. However, because stem cells are the longest-lived cells in

any organ, they m

longevity.

Huang et al (2007) have reviewed data showing cancer stem cells identification in

leukaemia, breast cancer, brain cancer, multiple myeloma, prostate cancer, ovarian

cancer, colon and pancreatic cancer.50

Cancer stem cells however, appear more resistant to chemotherapy tha

cancer cells. Leukaemic stem cells have shown significantly less sensitivity to

daunorubicin than leukaemic blast cells,51 and myeloma cancer stem cells ha


61

kill as

ve therapy, the

possibility of future tumour development increases.

n

ill

?

s the

r breast cancer patients, but

Tamoxifen also increases mortality for women with a uterus, particularly women at

er.53 Tamoxifen gives a

in 2003

at the response rate of drug efficacy in oncology is only 25% is an astonishing

ility of

75% of patients treated with oncology drugs do not gain benefit and, indeed, often

o

esearch Fund in London conducted a study of

the long-term survival of 7 941 patients. The study found no difference in 10-year

shown greater resistance to standard therapies used in myeloma treatment (Al-Hajj

quoting Matsui 2004).52 Most chemotherapy regimes have been developed to

many tumour cells as possible, yet if cancer stem cells survi

Should we expect that this new understanding will be translated into a lessening of

the use of chemotoxic agents for the treatment of solid tumours—the most commo

tumours? Will future research concentrate on treatments that target cancer stem

cells? Will patients with cancers that are now known to contain these stem cells st

be encouraged into chemotherapy regimes

Tamoxifen Has Negative Effects on Survival from Breast Cancer

Tamoxifen is a drug commonly used as a cancer preventive agent. Not only ha

drug made little difference to 5-year survival fo

the lower end of the ‘high risk’ range for breast canc

heightened risk of the development of endometrial cancer.

Response Rate to Oncology Drugs Only 25%

For several years, Dr Allen Roses held the position of vice president of genetics at

one of the world’s largest pharmaceutical companies. His announcement

th

admission of the failure of chemotoxic therapies, and casts doubt on the ab

chemotoxics to effectively treat cancer.54

If

undergo immense pain and suffering from the treatment itself, it is difficult t

understand the continuation of such therapies.

Postoperative Radiotherapy Increases Mortality

Radiotherapy is often given as an adjuvant treatment for breast cancer following

mastectomy. The Imperial Cancer R


62

y patients and simple mastectomy patients, but

r

Radiotherapy of the chest region is known to cause multiple cardiovascular

uch as pericarditis, myocardial fibrosis, muscular dysfunction and

y)

Future Harm from Radiotherapy

ses

er

d carefully. Patients need to not only be given

formed consent, but also an informed choice of treatments and an explanation of all

ficantly since the advent of chemotherapy in the middle

s inherent after-effects and

motherapy has shown its worth in some of the rarer

ancers, but overall improvement in cure rate and long-term survival for the most

common cancers remains low.

survival between radical mastectom

there was a significant excess of deaths in patients given radiotherapy.55

In randomised, controlled clinical trials of patients with intermediate-risk

endometrial cancer, postoperative radiotherapy decreased the incidence of cance

recurrence, but had no appreciable effect on overall survival.56

complications, s

valvular abnormalities. Patients at highest risk were breast cancer (post mastectom

and Hodgkin’s disease survivors who had received radiotherapy. The risk of fatal

cardiovascular disease increased with higher dose volumes of exposure to the heart,

and with the youth of the patient.57

There is no doubt that radiotherapy can shrink tumours. However, eradication of a

tumour as the sole treatment necessary to ‘cure’ a patient is debatable; in most ca

long-term survival is not significantly increased. The possibility of future harm aft

radiation must also be considere

in

future repercussions.

Conclusions

Whether cancer patients are receiving the best treatments possible is a real issue—

especially for the cancer patient. From a patient’s perspective, treatment types and

styles have not changed signi

of the last century. Fear of treatment itself is a significant factor for patients.

Surgery has improved in many ways, helped especially by new guided imaging

techniques. Radiotherapy has also advanced, yet still ha

dangers for the patient. Che

c


63

As discussed in Chapter 2, A Century of Cancer Statistics, the results of current

l of the disease. The journals, books and articles

ight be expected.

t area of

treatments are not indicative of major changes in treatment modes or of increasing

efficacy in long-term contro

body of research into cancer cause, but the reviewed in this research show a vast

thrust of research has not expanded in as many directions as m

The infective causes of cancer have largely been overlooked and ignored by

mainstream cancer researchers. Research into perhaps the most importan

neglect, bacterial induction of cancer, is discussed in the following chapter,

Chapter 4, Bacterial Involvement in Cancer.

1

Information, American Cancer

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27 Einhorn LH & Donohue JP (1977), 'Improved chemotherapy in di

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28 Bonadonna G, Brus

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31 Cody G (1985), 'History of Naturopathic Medicine

Natural Medicine, Seattle, WA, John Bastyr College Pulos.

32 Heron JF (2006), 'Some histori

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ac y

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35 Barton R, Hoskin P & Yarnold J (1994), 'Radiotherapy for bone pain: is a single fraction good

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36 Turner JH, Claringbold BG, Heatherington EL, Sorby P & Martindale AA (1

phase I study of samarium 153 ethylene diaminetetramethylene phosp

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37 Janjan NA (1997), 'Radiation for bone metastases: conventional techniques and the role of system

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38 Finder SG (1995), 'Lessons from history: Horace Wells and the moral features of clinical contexts',

Anesthesia Progress 42(1): 1-6.

39 (2002), 'The History of Cancer', American Cancer Society, viewed 10 September 2006,

<http://www.cancer.org/docroot/CR

40 (ibid.).

41 Sainsbury R, Haward B, Rider L, Johnston C & Round C (1995), 'I

nd patterns of treatment on survival from breast cancer', The Lancet 345(8960): 1265-70.

42 Kehoe S, Powell J, Wilson S & Woodman C (1994), 'The influence of the operating surgeon's

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43 Heron JF (2006), 'Surgery for cancer', Oncoprof: General Oncology, viewed 2006,

<http://www.oncoprof.net/Generale2000/g07_Chirurgie/gb07_ch01.html>.

44 Beardsley T (1994), 'A War Not Won', Scientific American, January: 119-26.

45 Abel U (1992), 'Chemotherapy of advanced epithelial cancer - a critical review', Biomedicine &

Pharmacotherapy 46(10): 439-52.

46 Kearsley JH (1986), 'Cytotoxic chemothe

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47 Abel U (1992), 'Chemotherapy of advanced epithelial cancer - a critical review', Biomed

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48 Morgan G, Ward R & Barton M (2004), 'The contribution of cytotoxic chemotherapy to 5-ye

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49 Al-Hajj M, Wicha MS, Benito-Hernandez A, Morrison SJ

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50 Huang EH, Geidt DG, Li CW & Simeone DM (

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51 Costello RT, Mallet F, Gaugler B, Sain

ute myeloid leukemia CD34+/CD38- progenitor cells have decreased sensitivity to chemotherap

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53 Melnikow J, K Nuovo J (2006),

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54

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logy

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55 Cuzick J, Stewart H, Peto R, Baum M, Fisher B, Host H, Lythgoe JP, Ribeiro G, Scheurlen R &

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57

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13(3): 346-56.

Changes in Cancer Research: Research Findings, Economics, Philosophy Jennie Burke – April 2007 Chapter 4 – Bacterial Involvement in Cancer

Chapter 4

Bacterial Involvement in Cancer

67

In this chapter I present another history of cancer research, an investigation of the

same standing as the methods discussed in the

ormation spread appears to have been actively

discouraged. This suppression of information has occurred in three main ways and

ancer medicine, trivialising and

ds

the dominant approaches.

e to selected papers, chosen on the

urvey of this work is beyond the scope of this research..

s a cause of disease. When Pasteur postulated that disease arose

these tiny

research that has not received the

previous chapter, in acceptance and practical usage, and in the acquisition of research

funding and clinical trials. In particular, the discussion focuses on research that

indicates a bacterial cause of—or involvement in—cancer.

Not only are these lesser-known areas of cancer research not mentioned in most

medical textbooks, but inf

continues to occur:

Ü Failure to fund such research,

Ü Proclamations from people of importance in c

negating such research results, and

Ü Omissions from medical teachings of a complete history of research in fiel

differing from

The following discussion is supported by referenc

basis of the standing of the researcher or the scale of the study. A comprehensive

s

Early Research on Bacteria

Pasteur: Bacteria as Cause of Disease

Louis Pasteur (1822–1895) dominated the scientific community of the day with his

work on bacteria a

from germs attacking the body, his findings were debated hotly amongst the medical

establishment. The notion that large organisms could be endangered by

bodies appeared ludicrous at the time to many medical practitioners.


68

lar

rganism in

weakened state. His work on the cause and treatment of rabies, through

910), eventually giving rise to the discipline of bacteriology.

Ko s

co

ca for

tub

Ko

Ko ing

whether a bacteria could cause a particular disease:

e bacteria is

inoculated into a healthy susceptible host.

rium leprae that causes leprosy cannot be

ed Ferdinand Julius Cohn established the concept of

orphism—meaning that a bacterium has a constant form and does not change.

He continued with this work and later showed that anthrax was caused by a particu

bacillus. Subsequently, he developed a vaccine, produced from the same o

a

vaccination, led to the acknowledgement of his work and his eventual honour and

fame.1

Koch: The Rise of Bacteriology

The discoveries of Pasteur laid the foundation for the work of other scientists such as

Robert Koch (1843–1

ch isolated Bacillus anthracis and inoculated it into mice to cause anthrax, thu

nvincing the medical community that these tiny bodies—bacteria—actually could

use disease. Koch later also isolated and identified bacteria as causative agents

erculosis and cholera.

ch's Postulates

ch is still remembered for his criteria—known as Koch’s Postulates—for judg

Ü The bacteria must be present in every case of the disease.

Ü The bacteria must be isolated from the host with the disease and grown in

pure culture.

Ü The specific disease must be reproduced when a pure culture of th

Ü The bacteria must be recoverable from the experimentally infected host.2

Current bacteriology has subsequently discovered some exceptions to this definition.

For example, the bacteria Mycobacte

grown in ‘pure culture’; and generally-accepted ‘harmless’ bacteria may cause

immense damage if an immuno-compromised patient becomes infected.

Monomorphism

However, there is still an adherence to these principles. The work of Koch, Pasteur

and a botanist nam

monom


69

rax

The monomorphist approach to some extent survives today and becomes relevant to

de the

following statement:

been more or less

ss

the natural tissues of the body, and that they differ only in degree, and,

perhaps, in certain properties which they have acquired from the natural elements.

may not again be applied to malignant tumours, with this difference, that the

ceived to be parasites, but to contain them.4

1889: Parasites Found in Cancers

ther scientists. Dr

of

Cohn3 had been editor of the journal Beitraege, in which Koch’s work on anth

had been published, and he was generally well respected in bacteriology.

the discussion later in this chapter.

1884: Tumours Contain Parasites, But Are Not Caused by Parasites

In 1884, the President of the Royal College of Surgeons, Dr Henry Butlin, ma

The theory of parasitism, applied to tumours, has during centuries

popular with surgeons; for in no other way can some of the most complicated processes

of malignant tumours be so well explained, as by assuming that the tumours or their

elements are parasitic. But of late years the parasitic theory has been discredited by the

discovery that the elements of even the most malignant tumours are derived more or le

directly from

It is quite clear, therefore, that the view, formerly maintained, that malignant tumours are

actually parasites is incorrect. But the recent discoveries of micro-organisms, and of the

part they play in relation to certain diseases, have led me to consider whether the theory

of parasitism

tumours are no longer now con

This is the first reference I have found to the concept of a bacterial cause of cancer.

The term ‘parasite’ was common when referring to ‘bacteria’ in earlier years.

Certainly the search for the elusive ‘parasite’ did not cease then.

This statement was followed in quick succession by several o

Thoma published a paper Ueber-eigenartige parasitare Organismen in den

Epithelzellen der Carcinome (translated as Over-peculiar parasitic organisms in the

Epithelial Carcinoma) in 1889 in the journal Fortschritte der Medicin (Progress

Medicine).


70

arasitarer protozoaartiger

e

ours, but he also produced a vaccine from

He claimed that his vaccine produced cures in cancer patients.5

9

ethods to demonstrate

x year period, he had examined

s only appeared at the growing edges of the tumours where

not where there appeared to be degeneration or reversal of

6

is

925: Micrococcus Cultured from Breast Cancer

tive micrococcus (unidentified but

oup) from a breast tumour. Inoculation

with this bacteria into mice and dogs caused the growth of some pre-cancerous

In 1890 in the same journal, a paper entitled Ein p

Organismus in Carcinomen (A Parasitic Protozoan Organism in Carcinoma) was

published by the scientist Nils Sjobring.

1885: Cancer Vaccine from Bacteria

In 1885, a French scientist Thomson Doyen not only isolated a bacterium (that h

named Micrococcus neoformans) from tum

the bacteria.

1899: Histology Shows Parasites in Active Parts of Tumour

The monograph On the Aetiology and Histology of Cancer, published in April 189

by Dr H.G. Plimmer, outlined various staining and fixing m

cellular inclusions. Plimmer also stated that, over a si

tissue from 1278 cancers (excluding sarcomas) and had found parasitic bodies in

85% of these.

Interestingly, he did not find these organisms spread homogenously throughout the

tumours. The organism

the cells were active, and

the tumours.

1911: Virally-Induced Cancer

In 1911, Peyton Rous published one of the earliest proofs of virally-induced cancer

in A Sarcoma of the Fowl Transmissible by an Agent Separable from the Tumour

Cells7. Significantly, it took until 1966 for him to be awarded a Nobel Prize for th

discovery.

1

Dr J. Nuzum, in 1925, cultured a minute gram-posi

possibly a member of the streptococcus gr

lesions and, in some cases, mammary carcinomas. Control mice inoculated with

cultures of other strains of streptococcus and staphylococcus did not develop such

lesions.8


71

925: Cancer Induced by Virus with an Irritant

hough

rovoking the host cell to multiply.9

cy in microscopy techniques was needed to allow

1930: Pleomorphic Forms from Cancerous Tissue

In 1930, Dr T.J. Glover, working at the Hygienic Laboratory in Washington, found

earing as intra-cellular

s

passage, the rats developed peritoneal

carcinomas with metastases to the upper abdomen, peritoneal endotheliomas with

patients.

1

Also in 1925, The Lancet published a section entitled New Research into the Origin

of Cancer including papers from Gye and Barnard. Dr Gye had come to the

conclusion that cancer was a disease caused by a virus or group of viruses. Alt

he found that the virus alone was insufficient to induce cancer, in the presence of an

‘irritation’ such as coal-tar or paraffin oils the virus would multiply in the cell,

p

Dr. Barnard’s paper was on microscopy techniques for the examination of small

filterable spheroids. Consisten

other researchers to view these small organisms.10

an organism that was shown in subculture to be highly pleomorphic: thus its life

cycle included coccoids, rods, mycelial stages and filter-passing forms. These

organisms were able to be stained in cancerous tissue, app

forms.

He obtained such an organism from an adenocarcinoma of the human breast. He

inoculated the organism into the breast tissue of full-grown female guinea pigs and

female albino rats. Tissue from the resulting lesions was cultured and the organism

obtained were sub-cultured several times, before being passed through four

successive groups of rats. After the fourth

focal infiltration.11

Glover found this organism in 85% of 3000 cases.

Further Studies on Pleomorphic Forms

Glover’s work was reproduced by Dr J.L. Engle in Philadelphia, and, subsequently in

a larger study by Dr George A. Clark. Clark found that he could consistently isolate

a highly pleomorphic organism from blood or tissue biopsies from his cancer


72

esent.12

Canada, O.C. Gruner was also studying pleomorphic organisms and cancer. He

t examination.

.

Ü An organism of the same type was found in seven previous cases.

uman blood.13

941: Pleomorphic Forms from Hodgkin’s Lymphoma

s, mycelia and rod forms. He inoculated blood from a

used cancer. He had

ublished earlier (1934) on this organism, which he had cultured from human

In this study, the organisms were cultured from patient tissue and the filtrate injected

into two guinea pigs. One was given 1 cc of the filtrate and the other 5 cc. The

guinea pig receiving the larger dose died 45 hours later. A drop of blood was

aspirated from the heart and the liver of this guinea pig. The blood was cultured and,

by the next morning, the same motile bacillus could again be shown to be pr

In

isolated such an organism, which he named Cryptomyces pleomorpha, from a breast

tumour. He found that:

Ü The organism could be detected in circulating blood by direc

Ü It was detected amongst tumour cells in the original neoplasm

Ü It resembled a fungoid organism, but with additional distinctive features.

Ü The organism in living cultures mimicked the cell-elements of h

1

Dr Mazet, a French physician, in Extrait de Montpellier Medicalle (1941), wrote of

finding a bacteria in a patient with Hodgkin’s disease. He then cultured an acid-fast

organism from 12 Hodgkin’s patients. He regarded the organism as highly

pleomorphic, with phases varying from small granules to fungal type elements,

including coccoid form

Hodgkin’s patient into a mouse that, when sacrificed 15 days later, yielded the same

organism from its brain tissue.

1948: Siphonospora from Cancer Tissue

In Germany in 1948, Von Brehmer published his work on an organism, which he

named ‘Siphonospora polymorphs’, that he claimed ca

p

blood.14 He found that this organism parasitised epithelial cells, as well as

erythrocytes and leucocytes. Von Brehmer developed a therapy that involved the use

of pooled cultures of ‘Siphonospora’ isolated from several different types of

neoplasm.


1952: Pleomorphic Studies of Micromyces

73

called

le

ugh a fine filter). One of the stages in its life-cycle resembled a

ycoplasma-like organism.15

erous

e effects.16

”

In total, he examined 31 types of cancers and found the virus to be present in all but

d

lthough he obtained positive cultures from 10 lymph nodes of Hodgkin’s

e

and baby chickens: 25% of the injected animals developed cancers. These included

indle cell sarcoma,

ncluded that the

oculations were not cancer cells from the host, but viral forms that induced a

cancer.

From more than 1000 samples of tumour tissue, blood and ascites fluids of cancerous

patients, Franz Gerlach isolated a pleomorphic, filter-passing organism that he

Micromyces blastogenes. He later renamed this organism Micromyces universalis

innatus and regarded it as a micro-fungus. Again, this organism was filterable (ab

to pass thro

M

Gerlach produced a ‘polyvalent’ vaccine by passing the organism through num

passages of culture media. He claimed his vaccine stopped the growth of cancers

enabling many patients to go into remission, without sid

1955: Cancer ‘Virus’ Extracted from 1000 Cancers

Dr John E. Gregory published the last edition of his book “Pathogenesis of Cancer

in 195517. In it he described finding cell wall deficient forms, which he referred to as

a cancer virus, extracted from tissue samples of 1000 human cancers.

eight of the 1000 samples. The negative results were found in five Hodgkin’s bloo

cultures, a

patients. He could not culture the virus from two lymphosarcoma patients’ blood

cultures, but had positive results from five other patients with the same disease.18

Gregory produced a culture from malignant melanoma, which he injected into mic

cancers of the ovary, adrenal gland, breast and stomach, sp

myosarcoma and leukaemia. His control group, which was larger than the research

group by a factor of ten, developed no malignancies.

Gregory found that the virus isolated from the induced cancers was the same as the

injectable form, and could be re-cultured to again produce the same cancer. Because

the types of cancer varied from the original melanoma, he co

in


74

uld affect this virus he

bacteria Bacillus subtilis Tracy 1. He produced a filtrate of this bacteria, mixed it

ts

developed album

this m

Gr d

M acillus subtilis Tracy 1 bacteria.

regomycin was produced from a Streptomycetes and the fourth—called Gregocin—

ed to be

tics that linked them

to Mycobacteria, but that at other times they resembled spore-forming bacteria.19

a Isolate

lara Fonti wrote on the parasitic theory of cancer and the transmissibility of cancer,

s were diagnosed as baso-cellular epithelioma.

Early Drugs Utilising Bacterial Effect on Virus

Gregory experimented with various bacteria to find if they wo

had found, and had some success in his treatment of cancer patients, using the

with a saturated magnesium sulphate solution, and gave this to patients as a daily

injection.

He showed many remissions using this treatment, particularly in late-stage patients

for whom no other treatments were used. Unfortunately, many of the patien

inuria, indicating a renal problem with this drug. It is possible that

ay have been caused by the magnesium sulphate.

egory produced four antibiotics in his search for a cancer treatment. Tracin an

agnesium Tracinate were produced from the B

G

was produced from an unnamed mould. Among these, Gregocin was the most

effective in cancer treatment.

1955: Dark Field Microscopy Reveals Pleomorphic Forms in Blood of Cancer

Patients

In Paris, Dr E. Villequez used dark field microscopy, noting what appear

bacteria in the blood of cancer patients. When cultured, the organisms were noted to

be highly pleomorphic. He wrote that they had some characteris

1959: Scientist Self-Inoculates with Carcinom

C

citing 30 cases from her own practice.20 To demonstrate transmissibility, she

inoculated herself in the chest wall with fluid from a metastasising mammary

carcinoma. After a few days, an erythematous papillary eruption developed between

her breasts, growing into a nut-sized lesion with numerous small ancillary papules.

These papule


75

Wheeler et al, Pleomorphic Studies on Neoplasms

Dr Virginia Livingston-Wheeler worked with many distinguished scientists

nd

at

the non-acid-fast coccal forms could appear as single, double, or as densely-packed round

n to the smallest

re filterable and virus sized.21

n women

Her

r familiarity with the

concept of pleomorphism, and she described some of these variants in her

Fonti’s own blood was then transfused to a patient with multiple abdominal

metastases, giving an amelioration of the patient’s condition.

1948–1990: Livingston-

throughout her long career, including Dr Roy Allen, an expert microscopist a

histologist. In August 1948, Allen published The Microscopy of micro-organisms

associated with neoplasms, in which he stressed the pleomorphic appearance of the

microbe isolated from the blood of cancer patients. Cantwell quotes Allen:

He described it as ranging in appearance from a rod-shaped or coccus shaped form. Th

forms. That these coccal forms could vary in size from 1 micro

microscopic size the eye could detect with a microscope approx. 0.2 microns, and that the

microbe could live both inside and outside the cells, and that the tiniest forms of the

cancer microbe we

Livingston-Wheeler collaborated for many years with three well-know

scientists who undoubtedly influenced her research and career:

Ü Eleanor Alexander-Jackson PhD, a Cornell University microbiologist.

work with the tuberculosis mycobacterium gave he

PhD thesis (published in the American Review of Tuberculosis).

Ü Irene Diller PhD, a cell cytologist at the Institute for Cancer Research in

Philadelphia and editor of Growth, a biological journal.

Ü Florence Seibert, a well-known refereed tuberculosis researcher, famous for

her development of the TB skin test.22

The paper Cultural Properties and Pathogenicity of Certain Microorganisms

obtained from various Proliferative and Neoplastic Disease23 was first published in

1950, a team effort by Virginia Wuerthele-Caspé (Livingston-Wheeler’s name from

a previous marriage), Eleanor Alexander-Jackson, John Anderson, James Hillier and

Roy Allen.


76

om normal controls. When

inoculated into experimental animals, the cultured organisms induced characteristic

riable mycoplasma from the blood

nd tumours of Rous virus-infected chickens and from other sources of the virus.

hic intermittently

acid-fast organism with a mycoplasma transitional L phase, belonging under the Order

ith

Wheeler established her first cancer clinic in San Diego in 1969 and

produced an autologous vaccine (utilising her Progenitor cryptoceides organism) for

, Owen Webster Wheeler,

d

were unreserved in their praise of the treatments

In this they described how they cultured pleomorphic organisms from human and

animal neoplasms, and that these could not be cultured fr

pseudocaseous lesions.

1966: Studies on the Rous Virus As a Pleomorphic Form of Mycoplasma

An important paper was published in 1966 by Eleanor Alexander-Jackson, who had

been working for some time with the Rous virus. She had isolated, many times and

over many years, a highly pleomorphic, gram-va

a

Dr Alexander-Jackson24 postulated that the Rous virus was:

... the virus-size stage and virus-like form of a single type of pleomorp

Actinomycetales.

1969: Livingston-Wheeler Cancer Clinic and Autologous Vaccine

Livingston-Wheeler, in conjunction with Alexander-Jackson in 1970 and later w

her husband Afton Livingston in 1972, published papers on their culturing of

organisms with filterable cycles and acid-fast cycles.25 26

Livingston-

the treatment of cancer patients. Her later husband

developed a malignant lymphoma of the neck in 1972, and he chose to treat it only

with the vaccine. The lymphoma was reportedly gone in six months.27

Late 1990s: Positive Responses from Clinic Patients

In the late 1990s (after her death in 1990) I visited the Livingston-Wheeler clinic an

spoke with several patients being treated there. Most of these patients had been

considered terminally ill by their conventional oncologists. They had gone through

standard treatments and were now seeking ‘other’ treatments in their search for a

cure or prolongation of life. They


77

f the cancer vaccine; several were in

l endocarditis and colorectal carcinoma

as raised in 1973 by Dr Daniel Roses and Dr Arthur Localio, following their

ust be considered as speculative, but the

ch.

Alan Cantwell, a dermatologist who

what his mentor, began to publish on the

d in breast cancer, lymphoma,

Kaposi’s sarcoma.29 30 31 When Dr Cantwell

s histology slides,

learly showing the acid-fast bacteria that he had isolated from many of his

anisms I have

nd

received, which involved primarily injections o

remission and were undergoing maintenance treatment.

1973: Link Between Bacterial Endocarditis and Colorectal Carcinoma

The possible association between bacteria

w

investigation into three patients presenting with bacterial endocarditis and carcinoma

of the colon or rectum.28 Each patient was treated with antibiotics for endocarditis

followed by surgical removal of the carcinoma.

A causal link between the two conditions m

authors suggested that in patients with no history of heart disease, the concurrent

development of these diseases certainly warrants further resear

1970s–1980s: Histology of Pleomorphic Forms in Cancers

Between the late 1970s and early 1980s, Dr

considered Dr Livingston-Wheeler some

presence of pleomorphic organisms he had foun

Hodgkin’s disease and pre-AIDS

retired several years ago, he kindly sent me a collection of hi

c

patients32.

Cell Wall Deficient Forms and Mycoplasmas

I have had a particular interest in pleomorphic forms from my 22 years of work with

darkfield microscopy, examining and comparing the blood of patients with cancer to

the blood of non-cancer patients.

I have been both intrigued and disturbed by the variable forms of org

seen in the cancer patient’s blood but not in the blood of healthy subjects. I have

travelled to many research centres over the last 20 years, discussing my findings a

asking advice and explanations from many eminent scientists. Highlights from my

discussions are presented below.


78

993: Mattman on Cell Wall Deficient Forms

Wall

er knowledge of cell wall deficient bacteria and of the strange group of divergent

in

to work with cell wall deficient bacteria, Professor

phenomenon.

sintegrate totally if fixed on a slide by heating (the standard

method of fixing).

s is exceedingly difficult: They are more

ssical forms of the organisms. The

l form, making

shift

n

ate 20th Century: Mycoplasmas in Gulf War Syndrome Patients

rial

wall

of

1

In 1993, prior to convening the 1st World Congress on Cancer in Sydney, I spent a

week in the USA at the microbiology laboratory of Professor (now Emeritus

Professor) Lida Mattman. I had been intrigued by the ideas in her book on Cell

Deficient Forms.33

H

organisms called Mycoplasmas has been invaluable to most researchers interested

this field. Although not the first

Mattman’s work has added greatly to the body of information on this

Bacteria that become cell wall deficient have the ability to make enormous changes

in their appearance. They have the following characteristics:

Ü They may di

Ü They usually grow on soft agar.

Ü They may grow within red blood cells.

Ü They are often serophilic.

Ü They often grow best in a hypertonic environment.34

Working with cell wall deficient organism

difficult and take longer to grow than the cla

appearance of a cell wall deficient form is totally unlike the classica

them difficult to identify by appearance. Identification may require promoting a

back to classical form, for example, the addition of penicillin induces a reversion i

cell wall deficient Candida to its classical form.

L

The end of the 20th century saw an increase in the investigation of Mycoplasmas.

Mycoplasmas are from the class Mollicutes, and are the smallest of the bacte

forms. Unlike other species of bacteria, Mycoplasmas are unable to make cell

components. They do not enter a cell wall deficient stage, but they do share many

the characteristics of the cell wall deficients.35


79

Gulf War

Syndrome patients showed the pathogenicity of Mycoplasma infection. Infections of

esting. Today, the

erging that indicate that Mycoplasmas may play a major

role in regard to

Mycopla ing Chr bility a ancy

Researchers at the American Regis f Pathology at the Armed Force ute of

Pathology, Washington, have shown that chronic infection, or colonisation by some

Myc ines induced mosomal instability and malign

trans

r growth of

d

ation

Affinity of Mycoplasmas for Cancer Cells

y for

ntaminants of cancer cells does

ot yet appear to be have been answered. Testing for contamination is now

The work of Professor Garth Nicolson on the diagnosis and treatment of

Mycoplasma pneumoniae were identified through antibody t

Polymerase Chain Reaction (PCR) test is considered the ‘gold standard’ for

identification of such organisms. Infections are treated with antibiotic therapy.

Many papers are now em

human disease.

smas Induc omosomal Insta nd Malign

try o s Instit

oplasmas in cell l chro ant

formation.

Their hypothesis was that chronic infection could promote tumou

mammalian cells. They also showed that infection by several—but not all—species

of Mycoplasma would prevent murine myeloid cells from undergoing apoptosis, an

that these Mycoplasma-infected cells gradually underwent malignant transform

over a period of four to five weeks. The two Mycoplasma strains used in this study

were M. fermentans or M. penetrans36.

One the most fascinating characteristics of the Mycoplasmas is their affinit

cancer cells. All scientists working with cancer cell lines must continually check

them for Mycoplasma infection, and many papers are devoted to studies of how to

eliminate Mycoplasmas from these cells.37

Why these particular species are the most likely co

n

recommended, by DNA fingerprinting or cytogenetic analysis, as the effect of

Mycoplasmas in the cell lines may render research data highly unpredictable and

questionable.38 Much research—performed prior to DNA technology, utilising cell


80

by

es.

nable studies have been carried out the results are frightening. A study

from China by Su Huang, published in World Journal Gastroenterology, gave the

ber Positive

lines—should be repeated with attention to possible infiltration of the cell lines

Mycoplasmas, in order to verify the published outcomes of the studi

Stats on Infection of Cancer Patients with Mycoplasmas

The numbers of cancer patients who are infected with these bacteria is unknown, but

where reaso

results shown below.39

Table 4-1: Mycoplasma Infections in Cancer Patients

Cancer Type Number Positive for Mycoplasma

Total Patient Num

Percentage

Breast Cancer 25 63 39.7%

Colon Cancer 32 58 55.1%

Adenomarous polyp 10 49 20.9%

Gastric Carcinoma 50 90 56.0%

Oesophageal Cancer 27 53 50.9%

Lung Cancer 31 59 52.6%

Glioma 38 91 41.0%

Connection Between Helicobacter pylori and Gastric Cancer

s showing its role in the induction of stomach ulcers.

Agency for Research on Cancer.40 H. pylori has a positive association with gastric

world’s population is

articularly prior to 1940, based on their

ability to pass through specific filters. Bacteria were larger so they were trapped by

size of the filters used at that time,

ork by Wainwright42 showed that the presence of the culture medium

affected the ability of bacteria to pass through a 0.2 micron filter. When bacteria

were given overnight incubation in a culture medium on the membrane, they formed

Another bacteria, Helicobacter pylori, has been much in the news lately. A Nobel

Prize was won by researcher

This bacteria was classified as a human pathogen in 1994, by the International

cancer. According to Correa (2003), more than half the

infected with H. pylori.41

Early Misclassification of Mycoplasmas and Cell Wall Deficient Forms

Viruses were distinguished from bacteria, p

the filter, whereas viruses passed through. The

however, allowed bacteria such as mycoplasmas to easily pass through, so they

would have been mistakenly classified as viruses.

Recent w


81

the filter. The

d.

f Cancer

e

viral

.

igh Incidence of Infection in Cancer

veloping countries, the prevention of these infections would lower the

cancer rate by 21%.

llomaviruses are attributed with causing 89% of cervix cancers.43

arcinoma, compared with those who have had typhoid and have

uccessfully cleared the infection.44 45 46

elate

neumoniae has been reported to be associated with a 50% to 100% increased cancer

sk.50

small (cell wall deficient) forms that were able to pass through

bacteria that Wainwright used were all common human pathogens.

This finding has significant repercussions for the field of microbiology, and may

indicate that studies carried out over the earlier part of the 20th century should be re-

examine

Renewed Interest in Bacterial/Viral Induction o

Following the large body of research from the late 19th century through the first thre

quarters of the 20th century, there has been a renewed interest in bacterial and

induction, promotion of, and affinity with neoplasm

H

A 1997 paper by Pisani et al estimated that, in 1990:

Ü 15.6% of the worldwide incidence of cancer could be attributed to infection

with either the Hepatitis B or C viruses, Helicobacter pylori, schistosomes or

liver flukes.

Ü In de

Ü The papi

Salmonella Infections Linked to Gall Bladder Cancer

Strong epidemiological evidence supports a link between infections with Salmonella

typhi and gallbladder cancer. Carriers of S. typhi have 8.47 times the risk of

gallbladder c

s

Chlamydophila pneumoniae in Lung Cancer

Chronic infections of Chlamydophila pneumoniae are now being found to corr

with an increased risk of lung cancer.47 48 49 An elevated IgA antibody titre to C.

p

ri


82

Escherichia coli and Streptococcus bovis in Colon Cancer

everal bacteria have now been linked to chronic infections of the colon and an

n estimated at 18% to

I t for 40

C. When testing

t their

f

r routinely tested for pathogenic

the outcome

fo rst

no u derstanding is gained of the possible

b

al.

S

increased risk of colon cancer. These include Escherichia coli (McCoy and Mason

suggested this in 195151) and, in more recent studies, Streptococcus bovis. Colon

cancer incidence that may be associated with S. bovis has bee

62%.52

Infection in Oral Squamous Cell Carcinomas

Over 90% of oral cancers are oral squamous cell carcinomas (OSCC). These have

one of the lowest survival rates (based on 5-year survival statistics), with no

noticeable improvements in the last few decades.53

n a recent study, Mager et al used DNA identification of oral flora to tes

microbial species. Capnocytophaga gingivalis, Prevotella melaninogenica and

Streptococcus mitis were elevated in the saliva of patients with OSC

the presence of these three species as diagnostic markers, the authors found tha

presence could predict 80% of cancer cases and absence could predict 83% o

controls.54

Conclusions

Patients presenting with a cancer diagnosis are neithe

infections, nor routinely treated for infections at any time during their cancer

treatments. There do not yet appear to have been any studies showing

r patients if such infections are identified and eliminated when cancer is fi

diagnosed.

Ignoring the possibility of bacterial induction of cancer in screening—or as a

requirement in treatment—means that n

enefits of such treatment for cancer patients. Future expansion of treatment

modalities hopefully will answer this question and lead to improvements in surviv

1

(2002). Microsoft Encarta Encyclopedia.


83

h's postulates definition." Medical Dictionary Retrieved 15 June 2006, from

cal Discoveries of

urnal 1.

3-378.

fler HH, Former Investigations into the Microbic Origin of Cancer.

crococcus isolated from human

Associated with

cessful Culturing of Glove s Cancer Organism and Development of

rs in Animals Produced by Cu ures from Human Malignanacy. Sixth

e

roorganismus des Blutes und

roskopie 1 & 2.

astoses)." Der Krebsarzt 2.

ublishers.

e

5). Four Women Against Cancer Los Angeles, Aries Rising Press.

ltural Properties pathogenicity of certain Microorganisms

s 220:

2 (2007). "Koc

http://www.medterms.com/script/main/art.asp?articlekey=7105.

3 Enby E, G. P., Sheehan M, (1990). Hidden Killers - The Revolutionary Medi

Professor Guenther Enderlein. Saratoga CA, Sheehan Communications.

4 Butlin HT (1884). "Malignant Tumours and Parasitism." British Medical Jo

5 Doyen TA (1905). "The aetiology and treatment of cancer." Edinburgh Medical Journal 17: 37

6 Glover TJ, E. J., Clark GA, Lef

7 Rous P. (1911). ""A Sarcokma of the Fowl Transmissible by an Agent Separable from the Tumour

Cells." J. Exp. Med. 13: 397-411.

8 Nuzum JW. (1925). "The Experimental production of metastasising carcinoma in the breast of the

dog and primary epilelioma in man by repeated innoculation of a Mi

breast cancer." Gynecol Obstet. 11: 343-352.

9 Gye WE (1925). "The Aetiology of Malignant New Growths." The Lancet: 109-117.

10 Barnard JE. Ibid."The Microscopical Examination of Filterable Viruses :

Malignant New Growths." 117-123.

11 Glover TJ (1930). "The bacteriology of cancer." Can Lancet Pract 75: 92-111.

12 Clark GA (1953 ). Suc r'

Metastasizing Tumou lt

International Congress of Microbiology, Rome Italy.

13 Gruner OC (1935). "Cryptomyces Pleomorpha: A New Organism Isolated from the Blood of a Cas

of Metastasized Carcinoma of the Breast." Canadian Medical Association Journal: 15-19.

14 Brehmer W (1934). "Siphonospora polymorphs: n.sp., ein neurer Mik

Seine Beziehung zur Tumorgenese." Med Welt 8: 1179-1185.

15 Gerlach F (1952). "Erorterung des Krebsproblems vom Standpuckt der Bakteriologies (Discussion

of the cancer problem from the point of view of bacteriology)." Mik

16 Gerlach F (1961). "Immunbiologische Studien bei malign Tumoren und Hamoblastosen

(Immunlogical studies of malignant tumours and hemobl

17 Gregory JE (1955). Pathogenesis of Cancer. Pasadena, Fremont Foundation P

18 Ibid.

19 Villequez E (1955). Le parasitism latent des cellules du sang chez l'homme, en particulier dans l

sang des cancereux. Paris, Librairie Maloine.

20 Fonti CJ (1959). Etiopatogeneses del Cancro: Diagnosis, Prophylaxis Therapy. Milan-Varese, A.

Nicola and Co.

21 Cantwell A (200 .

22 Ibid.

23 Wuerthele-Caspe V (1950). "Cu and

obtained from various proliferative and neoplastic diseases." American Journal Medical Science

638-648.


84

Acad Sci 174: 636-654.

ts

Compendium - The microbioology of Cancer, Livingston Wheeler

ve of

7.

nt

.

histology sli es. J. Burke. San Diego.

36 Lo SC (1999). "Mycoplasmal Infections Prevent Apoptosis and Induce Malignant Transformation

of Interleukin-3-Dependent 32D Hematopoietic Cells." Molecular and Cellular Biology: 7995-8002.

37 Uphoff CC and Drexler HG (2002). "Comparative antibiotic eradication of Mycoplasma infections

from continuous cell lines." In Vitro Cell Dev Biol Anim 38(2): 86-89.

38 Drexler HG (2002). "Mix-ups and mycoplasma: the enemies within." Leuk Res 26(4): 329-333.

39 Huang S., L. J., Wu J., Meng L., Shou CC. (2001). "Mycoplasma infections and different human

carcinomas." World Journal Gastroenterology 7(2): 266-269.

40 (1994). IARC monographs on the evaluation of carcinogenic risk to humans. Schistosomes, liver

flukes and Helicobacter pylori. Lyons France, IARC

41 Correa P (2003). "Bacterial Infections as a Cause of Cancer." J.N.C.I. 95(7).

42 Wainwright M (2002). "Small Bugs Big Holes." Medical Hypotheses 56(6): 558-560.

43 Pisani P, P. D., Munoz N, Ferlay J, (1997). "Cancer and infection: estimates of the attributable

fraction in 1990." Cancer Epidemiol Biomarkers Prev. 6(6): 387-400.

44 Lazcano-Ponce EC, M. J., Munoz N, Herrero R, Ferrecio C, Wistuba II, Alonso de Ruiz P, Aristi

UG, Nervi F,. (2001). "Epidemiology and molecular pathology of gallbladder cancer." CA Cancer J

Clin 51: 349-364.

45 Welton JC, M. J., Friedman SM., (1979). "Association between hepatolbiliary cancer and typhoid

carrier state." Lancet 1: 791-794.

46 Caygill CP, H. M., Braddick M, Sharp JC,. (1994). "Cancer mortality in chronic typhoid and

paratyphoid carriers." The Lancet 343: 83-4.

24 Alexander-Jackson E (1966). "Mycoplasma (PPLO) Isolated from Rous Sarcoma Virus." Growth

30: 199-228.

25 Livingston VWC, A.-J. E. (1970). "A specific type of organism cultivated from malignancy,

bacteriology and proposed classification." Ann. N.Y.

26 Livingston VWC, L. A. (1972). "Demonstration of Progenitor cryptocides in the blood of patien

with collagen and neoplastic diseases." Trans. N.Y. Acad. Sci 34: 433-453.

27 Livingston VWC (1977).

Medical Clinic Publication US.

28 Roses DF, Richman H, et al. (1974). "Bacterial endocarditis associated with colorectal carcinoma."

Annals of Surgery 179(2): 190-191.

29 Cantwell AR Jr (1981). "Histologic observations of variably acid fast coccoid forms suggesti

CWD bacteria in Hodgkins disease, 4 cases." Growth 45: 168-18

30 Cantwell AR Jr (1982). "Variably Acid-fast Bacteria in a Rare Case of Coexistent Maligna

Lymphoma and cutaneous Sarcoid-like Granulomas." International Journal of Dermatology 21(2)

31 Cantwell AR Jr (1997). "The cancer microbe." Int J Microbiol 1: 7 - 15.

32 Cantwell, A. J. (1995). Collection of d

33 Mattman L (1992). Cell Wall Deficient Forms: Stealth Pathogens. Boca Raton, CRC Press.

34 Ibid. Boca Raton, FL.

35 Ibid. Boca Raton.


85

Koyi H, B. E., Gnarpe J, Gnarpe H, Steen B,. (2001). "An association between chronic infection

with Chlamydia pneumoniae and lung cancer. A prospective 2-year study." APMIS 109: 572-580.

48 Kocazeybek B (2003). "Chron iae infection in lung cancer, a risk factor:

a case-control study." J Med Microbi

49 Anttila T, K. P., Leinon Pukkala E, Paavonen J,

Saikku P,. (2003). "Chlamydia pneumoniae infection and the risk of female early-onset lung cancer."

Int J Cancer 107: 681-682.

McCoy WC, M. J. I., . (1951). "Enterococcal endocarditis associated with carcinoma of the

ates

of cancer-

47

ic Chlamydophila pneumon

ol 52: 721-726.

en M, Laukkanen P, Hakulinen T, Lehtinen M,

50 Littman AJ, W. E., Jackson LA, Thornquist MD, Gaydos CA, Goodman GE, Vaughan TL., (2004).

"Chlamydia pneumoniae infection and risk of lung cancer." Cancer Epidemiol Biomarkers Prev. 13:

1624-1630.

51

sigmoid, report of a case." J Med Assoc State Ala 21: 162-166.

52 Zarkin BA, L. K., Cameron JL, Effron PN, Magnuson TH, Pitt HA,. (1990). "The triad of

Streptococcus bovis bacteremia, colonic pathology, and liver disease." Ann Surg. 211: 786-791.

53 Canto MT, D. S., . (2002). "Oral cavity and pharynx cancer incidence rates in the United St

1975-1998." Oral Oncol 38: 610-617.

54 Mager DL, H. A., Devlin PM, Norris CM, Posner MR, Goodson JM,. (2005). "The salivary

microbiota as a diagnostic indicator of oral cancer: A descriptive, non-randomized study

free and oral squamous cell carcinoma subjects." J Transl Med 3: 27.

Changes in Cancer Research: Research Findings, Economics, Philosophy Jennie Burke – April 2007 Chapter 5 – Paths Not Followed

Chapter 5

86

Paths Not Followed

search—into the cause and

rbed into conventional medicine. In

nvironmental causes of cancer, an area that

ignificance it deserves in attempts to prevent cancer.

earch data, published from the 20th century to the

present, on treatments that have not been integrated into conventional

of why such treatments were proscribed and whether time

has justified their initial rejection.

pment of two contrasting treatment paths in oncology and what

hemicals in our environment have been linked to cancer induction.

been

There are three major criteria required in evaluating the potential of an

esis in humans.

r

This chapter highlights some of the key aspects of the re

treatment of cancer—that has not been abso

particular, I present:

Ü A summary of the chemical and e

has not been given the s

Ü A brief selection of res

oncology. Some of these treatments have been relegated, by the medical

establishment, to the negative category of ‘alternative medicine’.

Ü An investigation

Ü The develo

this has meant for patients.

Environmental Carcinogens

Numerous c

Many of these are used in industrial processes, and convincing evidence has

found to link workplace exposure with various cancers.

environmental chemical to induce carcinogen

1. Does the agent have in vitro mutagenic potential.

2. Do experimental animals show increased incidence of specific types of cance

when exposed to the agent.

3. Do humans show increased incidence of the same types of cancer when

exposed to the agent.1


87

ole of Industrial Chemicals in Cancers

n

g

es,

ancer Clusters

rs is

two

x osed to vinyl chloride at a

manufacturing plant.4

1 81 and 1990, in close proximity to three petrochemical plants.

. The

ithin

two to three kilometres of the plants.

R

Based on studies from the Institute of Cancer Epidemiology, the Danish Cancer

Society, the Cancer Registry of Norway and the Finnish Cancer Registry, it has bee

estimated if industrial carcinogens were eliminated in the world, then the followin

cancers could be avoided:

Ü 70% of mesotheliomas,

Ü 20% of cancers of the nasal cavity and sinus

Ü 12% of lung cancers,

Ü 5% of laryngeal cancers,

Ü 2% of urinary bladder cancers,;

Ü 1% of leukaemias, and

Ü 1% of renal cancers.2

The National Cancer Institute (NCI), and the national Institute for Environmental

Health Sciences (NIEHS), currently suggests that two-thirds of cancers are caused by

environmental factors.3

C

Cancer clusters are at times reported by the public. Investigation of such cluste

difficult for public health authorities as such investigation is difficult and often

inadequately performed. Environmental cause was determined in the following

clusters.

Ü Angiosarcoma of the liver in workers e p

Ü Childhood leukaemias in residents exposed to contaminated drinking water.5 6

The Danger of Close Proximity to Industry

Death certificates were examined for 28 children who lived in a residential area of

Taiwan between 9

An unusually high number of bone, bladder and brain cancers were found

children were aged from birth to 19 years, and all but one of them had lived w


88

piled by the Environmental Protection Agency of the Republic

ontaminant in well-water at levels far

Pesticide Use

pared the home locations of 1,000 cancer patients to that

in

e risk for all brain cancers and

aemia and cancers of the lip

rain cancer rates. A 1993 study

ticides,

7

of Massachusetts, Lowell, found strong

lung, and skin.

Ü Chlorination byproducts such as trihalomethanes and bladder cancer.

Pollution reports, com

of China, showed nine serious air pollution events that had released vinyl chloride

and acrylonitrile. Polycyclic aromatic hydrocarbons were also released from the

plants, and phenol had been found as a c

exceeding government safety guidelines.7

The Danger of Close Proximity to

Living in areas of high pesticide use has also been shown to increase rates of brain

tumours. A 1996 study com

of 1,000 patients dying of other illnesses. The study found that people living with

2,600 feet of a cranberry growing area had twice th

nearly a seven-fold increased risk for astrocytomas.8

Statistical data has shown that there is a higher incidence amongst farmers in

industrialised nations of multiple myeloma, melanoma, prostate cancer, Hodgkin’s

lymphoma, non-Hodgkin’s lymphoma, brain cancer, leuk

and stomach.9

Working with pesticides appears to increase b

followed the health of 2,310 Italian men, working with the application of pes

between 1972-1979. By the time the study ceased in 1988, there had been 20

deaths in the group. Of these deaths, seven were due to brain cancer. This is close to

2.5 times higher than the expected rate of 2.7.10

A summary of scientific evidence of environmental and occupational links to nearly

30 types of cancer was compiled by the Lowell Center for Sustainable Production.

The review, compiled by the Boston University School of Public Health and the

Environmental Health Initiative, University

causal links for: 11

Ü Metals such as arsenic and cancers of the bladder,


89

lioma,

ts, including motor vehicle exhaust

dder, lung, and

Ü Pesticide exposures and cancers of the brain, Wilms tumour, leukaemia, and

lymphoma.

ovary, skin, thyroid, leukaemia, multiple myeloma, and sarcomas.

oma;

cer; and trichloroethylene and Hodgkin’s

ble role in

re

chemicals is found at

ure.com/Basics/chemlist.htm.

re

Ü Natural fibres such as asbestos and cancers of the larynx, lung, mesothe

and stomach.

Ü Petrochemicals and combustion produc

and polycyclic aromatic hydrocarbons, and cancers of the bla

skin.

non-Hodgkin’s

Ü Reactive chemicals such as vinyl chloride and liver cancer and soft tissue

sarcoma.

Ü Metalworking fluids and mineral oils with cancers of the bladder, larynx,

nasal passages, rectum, skin, and stomach.

Ü Ionizing radiation and cancers of the bladder, bone, brain, breast, liver, lung,

Ü Solvents such as: benzene and leukaemia and non-Hodgkin’s lymph

tetrachloroethylene and bladder can

disease, leukaemia, and kidney and liver cancers.

Ü Environmental tobacco smoke and cancers of the breast and lung.

Endocrine Disrupters in Cancer Formation

Endocrine disrupters—such as diethystilbestrol (DES), dieldrin, chlordane,

hexachlorobenzene and triazine herbicides, which all have weak oestrogenic

activity—are being investigated in a range of environments for their possi

the increasing incidence of particular types of cancer.12

The European Commission Union Research on Endocrine Disrupters13 has identified

PCBs (polychlorinated biphenyls), dioxin, benzo(a) pyrenes, phthalates (plasticisers),

Bisphenol A, pesticides and heavy metals as having estrogenic effects. A mo

complete list of these

www.ourstolenfut

Known Carcinogens in Foods and Personal Products

Our chemicalised society is using more and more chemicals, many of which a

known carcinogens, in the environments in which we live and for personal use:


90

ntain talc, saccharins, fluorides,

formaldehyde, dyes and preservatives.

-D).14

alc As Carcinogen

ever,

ng used in powder form, talc is also used in

everal drugs as a colouring agent.16

Ü Clear evidence of carcinogenic activity of talc in female F344/N rats, based

s of

rom talc in B6C3F mice.17

n

found in

e (Nutra-Sweet®), used world wide in diet drinks and foods, has been posed

Ü Foods may contain antibiotics, pesticides, contaminants and additives.

Ü Cosmetics and toiletries may co

Ü Disinfectant sprays may contain orthophenylphenol (OPP).

Ü Weed killers may contain sodium 2,4-dichlorophenoxyactic acid (2,4

T

The situation for talc is another example of the confusion and ambiguity that exists

with respect to the regulation of potential carcinogens within our environment. If it

does not contain asbestos, talc is not considered a carcinogen by the FDA. How

talc on its own is being investigated as a potential cause of ovarian cancer if used

near the genital area.15 As well as bei

s

A 1993 Toxicology and Carcinogenesis Study of Talc by the US National

Toxicology Program found the following:

Ü Some evidence of carcinogenic activity of talc in male F344/N rats, based on

an increased incidence of benign or malignant pheochromocytomas of the

adrenal gland.

on increased incidences of alveolar/bronchiolar adenomas and carcinoma

the lung and malignant pheochromocytomas of the adrenal gland.

Ü No evidence of carcinogenic activity f

Should one err on the side of caution and not use talc? If talc was only available i

talcum powder, it would be an issue for individual choice. However, talc is

many products, from cosmetics to pharmaceutical drugs, making avoidance

extremely difficult.

A Sweet Danger

Aspartam

has having a potential role in the increase in brain cancer rates. Aspartame is

composed of aspartic acid, phenylalanine and methanol. On digestion, the methanol


91

as a safe product for human use is of extreme concern and

as raised questions as to the probity of the FDA in this issue. The original

1970, 11 years prior to the FDA approval for use of aspartame, Olney et al queried

ubmitted to the FDA as a basis for the

eir scientific validity

One of these supporting studies was carried out in 1972. In this study, infant

als

One animal in the

igh dose group died after 300 days of treatment. The cause of death was listed as

e following 218 days of treatment.

ently at various times and were of the grand

al type.22

ement

t me safety or to comment on the design of the studies.23 This

ocumentation is of concern, not only in the sparsity of good science shown in the

y oncluded that one study was

breaks down to formic acid and formaldehyde. Aspartame also decomposes to

produce diketopiperizine (DKP).18 19

The listing of aspartame

h

manufacturer of aspartame was G.D. Searle in the USA.

In

the potential of the chemical to cause neurotoxicity.20 21 Safety studies were carried

out by the manufacturing company and s

chemical’s approval. These studies were questionable in both th

and their results in relation to safety.

monkeys were given three levels of doses of aspartame over 52 weeks. All anim

in the medium and high dosage groups exhibited seizure activity.

h

unknown. Seizures were observed for the first tim

Sporadic convulsions occurred inconsist

m

In 1976, G.D. Searle representatives received FDA permission to hire a private

agency, the University Association for Education in Pathology, to validate 12

aspartame studies, at a cost of US $500 000.

Independent pathologists were informed that they were not to make a judg

about aspar a

d

initial safety studies, but also in the legitimacy of the FDA ruling of aspartame as a

‘safe’ food additive.

In 1980, the FDA convened a Public Board of Inquiry with prominent neuroscientists

W. Nauta, V. Young and P. Lampert, who were asked to evaluate two animal studies

linking aspartame to astrocytic brain tumours. The c


92

izarre and unreliable and that the other appeared to indicate that aspartame

DA

1981, the newly appointed Commission of the FDA, Arthur Hayes, approved

nd study outcome, it was found that:24

er-related (Nutrasweet®) funding.

(92%) of independent studies identified a problem.

It has been shown that the aspartame molecule exhibits mutagenic potential. When

re analysed for the

have reflected improved diagnostic technology, but a

r

ing of the increases paralleled the increased social use of

male and

significant, dose-related increase in

mphomas and leukaemias in the female rats compared to controls. This dose level

was very near those to which humans are exposed.26

b

contributed to brain tumours. They recommended further research. Additional F

experts concurred with the recommendations but studies suggested by the committee

were never carried out.

In

aspartame on the basis that the brain tumour risk was minimal.

When aspartame studies were surveyed in the medical literature for funding source

a

Ü 166 studies were relevant to questions of human safety.

Ü 74 studies had received manufactur

Ü 92 studies were independently funded.

Ü 74/74 (100%) of industry funding studies found the chemical to be safe.

Ü 84/92

A list of referred papers on Aspartame is found at

http://www.dorway.com/peerrefs.html.

brain tumour data (gathered by the National Cancer Institute) we

years 1975 to 1992, increases in incidence occurred in two distinct phases. The

initial modest increase may

secondary increase and shift towards great malignancy required explanation by othe

factors. The tim

aspartame.25

More recently, the European Ramazzini Foundation of Oncology and Environmental

Sciences in Italy administered Aspartame in varying concentrations to

female rats. The experiment followed the animals through to their spontaneous

deaths. It was found that there was a statistically

ly


93

y of aspartame…” EFSA

se that may

ave predisposed them to cancer.27

l. There

ed.

spartame is currently found in around 6,000 products worldwide.

iled

lists of environmental chemicals and metals known to be carcinogenic. This list

lbestrol (DES),

ching, incineration of toxic waste

and smelters,

uels, in

m

The European Food Safety Authority (EFSA) said it had evaluated the trial and

concluded that “there is no need to further review the safet

found that the rats in the study had a high rate of chronic respiratory disea

h

The strength of the science is difficult to ascertain when industry pays the bil

appears to be a plethora of studies on both the toxicity and safety of aspartame. With

this chemical, the precautionary principle does not appear to have been follow

A

NIH List of Environmental Carcinogens

The US National Institutes of Health and National Cancer Institute have comp

includes: 28

Ü Pesticides, such as ethylene oxide, DDT, lindane and lead acetate,

Ü Ionizing radiation , whether from medical procedures such as X-rays and

cancer treatments or from the presence of radon in the soil in or around

homes,

Ü Estrogens, Tamoxifen, and Diethylsti

Ü Solvents, such as benzene (known to cause leukaemia), chloroform and

methylene chloride,

Ü Fibres, fine particles and dust, including asbestos, ceramic fibres and wood

dust,

Ü Dioxins formed as by-products in paper blea

Ü Polycyclic aromatic hydrocarbons produced by burning wood and f

exhausts, and in smoked, barbecued or charcoal-broiled foods,

Ü Metals, such as arsenic, beryllium compounds, cadmium and cadmiu

compounds, chromium, lead and nickel.


94

State of California’s Environmental Protection

Agency provides a more complete listing on the website:

65single120806.pdf.

up we live in contains many potential carcinogens, and this

ancer incidence world-wide.

the environment. However, the increase in

ese carcinogenic chemicals is a new, largely invisible

phenomenon.

icals in most areas of our

on governments and scientific organisations for protection from

ens with potential to increase the incidence of cancer.

Unconventional Medicine

lternative medicine’ in oncology is regarded, by the medical establishment, as an

to

Complementary medicine’, more condescendingly, is

considered to be a “therapy used for symptom management and to enhance quality of

e cancer”.29

referred to collectively as Complementary

eatments discussed may have benefit as

ct therapies, to be used in conjunction with current

Integrative medicine is a title given to the combination of

.

ween treatments that are conventional and those that are

tive

ith legal redress in the case of

The above list is indicative of a much large compilation of chemicals known to be

carcinogenic. For example, the

http://www.oehha.ca.gov/prop65/prop65_list/files/P

The environmental so

may explain at least part of the steady rise in c

Humanity has always known danger from

exposure to most of th

Because we are exposed to synthetic and industrial chem

lives, we must rely

environmental carcinog

‘A

“unproven treatment, promoted for use instead of conventional therapy, claiming

treat the cancer itself”. ‘

life, but is not meant to treat th

In this chapter, these treatments are often

and Alternative Medicine (CAM). The tr

stand-alone treatments or as adjun

conventional therapies.

orthodox treatments with other forms of treatment

The delineation bet

alternative or complementary is fluid. Therapies that are proven safe and effec

may eventually, over time and as prejudices weaken, become absorbed into

conventional health care. Chiropractic and acupuncture were resisted with vigour by

conventional physicians, but they have now—w


95

f

Ü Ayurveda,

me extent),

Ü Hypnosis,

ines,

cted future research possibilities. Being

ioner or scientist is not beneficial to anyone’s career

chiropractic—largely become accepted as a standard health service by the public, i

not by conventional medicine.

Complementary and Alternative Medicine (CAM)

Complementary therapies are regarded as ‘soft’ treatments, and include:

Ü Acupuncture,

Ü Traditional Chinese Medicine (TCM),

Ü Homeopathy,

Ü Chiropractic,

Ü Herbs and nutritional medicine (to so

Ü Psychotherapy,

Ü Meditation,

Ü Massage.

Treatments that may actually kill cancer cells or affect the tumour are classed as

alternative, and include:

Ü Cancer vacc

Ü Injectable glandular extracts,

Ü High dose injectable Vitamin C,

Ü Injectable laetrile,

Ü Mistletoe lectin (Iscador),

Ü Hyperthermia,

Ü Electrochemotherapy (Galvannotherapy).

'Fringe' Science?

The labelling of treatments as ‘alternative’ has not only deprived most cancer

sufferers of access to them, but has also restri

known as an alternative practit

future within the current medical community.


96

ts listed

rly

hen their results are published in mainstream peer-reviewed journals. Once a

hy does a new and interesting treatment become labelled as ‘alternative’? Is it

rrent

al gain

ce and promote a treatment. The R & D must then be funded

by government or by a group motivated by altruism rather than profit. This is not to

medicine. Many companies

n used

y all peoples to treat the diseases that ailed them. Today, the use of western herbal

me n

he

Tr

He e

mo ntly referred to and

ersecuted as witches. Today, herbal medicine is increasingly recognised in the

In 18th century Europe a form of medicine called homeopathy was developed, based

When or why a treatment modality is described as alternative is unlikely to be the

decision of the research scientist or clinician involved. Many of the treatmen

above are regarded—by conventional oncologists—as fringe science or alternative

medicine. The scientists involved do not necessarily share this view, particula

w

modality is used routinely, it becomes conventional regardless of its origins.

Criteria for 'Alternative' Classification?

W

primarily because the new treatment requires such a paradigm shift that the cu

accepted dogma of medicine cannot face such a change (although this may not be the

reason given by those doing the labelling).

Could money be the major reason? If no patent is available, there is no financi

for a company to produ

say that the profit motive is excluded from alternative

and individuals have gleaned large incomes from the sales of alternative and

complementary products.

Herbal Medicine

All civilisations have a history of the use of herbal medicine. Herbs have bee

b

dicine, Traditional Chinese Medicine (TCM) and Ayurvedic Medicine (India

rbal medicine) is increasingly common.

aditional Healing Methods

rbal use in European countries was often the domain of wise women, who (in th

re male-dominated scientific medicine) were subseque

p

health policies of Australian federal and state governments, and courses are available

at several of our universities.30 31 32


97

amuel Hahnemann, a

facets

China, a complex system of medicine was developed over 3000 years, involving

.

eas from Hinduism.

yurvedic means “the science of life”. Their medical practice is based on the beliefs

, it increasingly diminished the

’.

al schools,

prevented from learning Latin (the prevailing language of medicine), and were told they

omen lay

lp, and the church re-sponded by persecuting

women in one of the most vicious rampages in her-story.35

on the “principle of similars”. Homeopathy was founded by S

German physician who developed his treatments by matching the symptoms

produced by a drug to symptoms exhibited by sick patients. He emphasised all

of a person’s health status, including emotional, mental as well as physical.33

In

not only the use of herbs but also of acupuncture, massage, diagnosis by pulse and a

view of the workings of the human body that is quite distinct from the Western view

Ayurvedic medicine was developed in India, based on id

A

that all things in the universe are interconnected, that disease is disharmony of the

person with the universe, and that disruptions may be physical, emotional, spiritual

or a combination of the three. Treatments may be herbal, dietary, massage or

yoga/exercise based.34

Effect of Scientific Medicine on Traditional Healing

When scientific medicine came to the fore in Europe

use of traditional healing. Women were banned from the study of medicine at

universities. Many women who had worked as healers were burned as witches—

primarily because of their religious beliefs, but their use of medicinal herbs attracted

attention and persecution. ‘Wise woman’ was equated with ‘witch woman

Women were excluded from educational institutions, particularly medic

were not allowed to practice because they were not qualified to do so. The w

healers (particularly the midwives) were competition for the guilds so the medical

profession appealed to the church for he

As a consequence, cottage industry competitors in this area were eliminated, leaving

the field open to control by universities and similar organisations.


98

Medicine into Traditional Systems

r

al stigma has

een attached to traditional medicine. In Singapore, for example, for many years it

stuff of witch-doctors and was not

encouraged or tolerated. ‘Proper’ treatment—drug therapy—became something to

ds were available to pay for it.

ing towards

edical

ain obstacles to overcome in proving new medical treatments

Integration of Scientific

Countries such as China and India did not discard their traditional medicine in favou

of the newer ‘scientific’ Western modalities. Over the last century, they have

integrated such approaches into a system of medicine that combines TCM and/or

Ayurveda with modern scientific medicine.

In contrast, in countries that had been colonised by Europeans, a soci

b

was more difficult to obtain TCM treatment than standard Western Medicine. TCM

use was associated with the ignorant and lower classes.

In the late 1990s, I visited Tanzania to discuss the possibility of a congress for HIV

treatments. I was told by the (then) head of the HIV programme for Tanzania that

the use of herbal medicine for HIV was the

aspire to if sufficient fun

Non-Delivery of 'Cure' by Conventional Medicine

If conventional medicine had successfully delivered the expected ‘cures’, then

alternative and traditional medicine would have gradually disappeared, but this has

not been the case. Over the last century there has been an increasing sw

self-treatment and the use of treatments outside the control of the m

establishment. This swing may reflect:

Ü An increase in dissatisfaction with the treatments of science.

Ü A greater tendency for people to take control of their own health.

Ü A steady increase in scientific studies showing efficacy with the use of

traditional methods.

Obstacles to Proving New Medical Treatments for Cancer

There have been two m

for cancer: cost and a social structure in medicine that is resistant to change of the

current scientific paradigm.


99

s.

over trials that meet the requirements of Phase I, II and III levels

f testing are costly ventures. These trials are only affordable by large institutions

e of

Herbs that have been used for millennia cannot be patented. Consequently, unless an

ments or academic

ls without the financial return of a patented medicine.

e

he second obstacle to proving new treatments is the attitude held by many scientists

treatment

or

Re

2005 study, presented in the New England Journal of Medicine (NEJM), found

rch, by a former Stanford physician, Wallace Sampson,

dis

scientific support.

ternative medicine in the USA.

Cost of Clinical Trials

Clinical trials must be large and well designed to satisfy current medical standard

Double blind, cross-

o

that are funded by governments, donations and companies and, especially in the case

of drugs, by pharmaceutical companies that have a vested interest in the outcom

the trials—a patented drug that will repay the investment over time.

active component of the herb can be produced as a new (and patentable) entity, the

funds to run large studies are difficult to source. Only govern

institutions can run large tria

As noted in Chapter 7, Academic Freedom—Academic Funding, this has becom

increasingly less likely to occur over time.

Resistance to Change

T

and doctors in the upper echelons of medicine. When those who have influence and

power at the highest levels are resistant to change, change is only likely to occur

through a paradigm shift. At what stage is a treatment ‘proven’? While a

modality is resisted by the power brokers, it may never be accepted.

jection of Herbal Medicine by Orthodox Practitioners

A

that Echinacea did not prevent colds or ease their symptoms.36 An adjacent opinion

piece on the Echinacea resea

missed herbal and other alternative remedies as implausible and unworthy of

37 Sampson had earlier called for the abolition of NCCAM, the

body set up by Congress to investigate al

A response to the NEJM study—from the American Botanical Council—was that the

dose used was too low, only one species of Echinacea was tested, and the group

tested fell in the category of the healthy young.38 Dr. Sampson’s response is a

common reaction by orthodox practitioners to studies of alternative medicine. It


100

flects the objectivity difficulties one might expect to experience when a group with

ant

-inflammatory effect.

th st y)

niversity from 1769 to 1813, his response to the idea of a healing power that might

icine at

gh to give a scientific encouragement that

something should be tested, so we identify the agent that is responsible, test it, purify it,

d trials and we have a winner.

r went on to state:

To suggest to people that something natural is inherently superior in a pharmacological

lants are highly toxic; the knowledge of toxic plants has been documented in the

re

a dominant paradigm studies the theories and practices of another group, with a

different paradigm.

The World Health Organisation promotes the use of herbs such as Echinacea, based

on over 350 experimental studies showing the herb’s ability to boost import

components of the immune system and for its anti

Unchanged Attitudes: Dr Rush (18 Century) to Dr Dwyer (21 Centur

The prejudicial attitudes of some professors of medicine does not appear to have

changed much over the last two centuries.

In lectures given by Dr Benjamin Rush, Professor of Medicine at Pennsylvania

U

be found in nature was to treat it “in the sick chamber as I would a squalling cat –

open the door and drive it out.” (Caldecott quoting Griggs, page 38).39

More recently, in a 2001 lecture entitled Dangers, Interactions and Adverse Events:

Facts and Fallacies of Natural Therapies, Dr John Dwyer, Professor of Med

NSW University, discussed the use of herbal medicine. 40 He stated that:

Anecdotes flourish, and are strong enou

standardise it, subject it to level one placebo controlle

The slide accompanying this stated, however, that “nature is intrinsically inferior”.

Dr Dwye

sense, or to suggest that because it’s natural, it’s likely to be harmless, that’s nonsense.

Dr Dwyer may be correct in stating that natural does not equate to harmless. Many

p

herbal pharmacopoeias for centuries. I disagree strongly, however, with Dr Dwyer’s

assumption that extracting the active agent in the plant, then purifying and

standardising it for testing, is the only way that these plants should be used.


101

e

cine. Such synergistic

effects are also employed in conventional oncology when combinations of

acy.

ted active fractions and never

the whole herb. Only the extracted fraction can be patented (if it is a new identity)

roduct.

D Dwyer has had a large impact on the attitudes of

n recent years in Australia. This impact occurred as Dr Dwyer

ent or that were already available, were naturally-sourced

ly aware of the

the chemicals in these plants may exert.46

contaminated seafood) may cause diarrhoea, cramping, and nausea, or if entering

There are many active chemicals in herbs, ranging from phenols, alkaloids and

steroids to terpenes.41 42 43 Synergism—where the effect of the combination of the

chemicals in the plant is greater as a whole, or where herbs used in combination giv

a heightened effect—is a time-tested mainstay of herbal medi

chemotoxic drugs are given to improve effic

The belief that only a treatment produced by a pharmaceutical company

(scientifically produced) should be used in medicine seems naïve and simplistic. Dr

Dwyer would seem to promote the use of only extrac

and produced by the pharmaceutical industry as a commercially viable p

Dr Rush44 had a profound effect on North American medicine in the 18th century,

with Pennsylvania University producing 75% of all medical practitioners trained

during his tenure. Similarly, r

medical practitioners i

headed a committee for the New South Wales Government into practices of

complementary medicine in this state. His role was to give guidance and advice on

the growing field of holistic medicine.

Synergism in Naturally Sourced Drugs

It was reported in 1999 that 62% of new anti-tumour and anti-infective agents, either

in late stages of developm

drugs.45

Researchers examining herbal products are learning of the difficulty of extracting all

the active fractions from plants, and are becoming increasing

synergistic and additive effect that many of

A combination of oregano and cranberry extracts was tested for antimicrobial

activity against Vibrio parahaemolyticus. If ingested, this bacteria, (found in


102

robial

by the mixture of the two. The researchers at

e University of Massachusetts then further enhanced the antimicrobial effect by

herbs are being tested for efficacy in the treatment of cancer, an

increasing number of their constituent compounds, alone and in combination, are

ic to cancer cells48, or to stimulate the immune system.

mentose also causes a stimulation of interleukin-1 and interleukin-6, giving an

o

50% of actively-proliferating breast cancer cell lines. As ovarian cancer and breast

cancer are two of the en

diagnosed with cance ly use her s all potential

treatments are

Curcumin

Curcumin is an extract from ices of curry and turm

curcumin have shown it to be a powerful antioxidant, to have anti-inflammatory

properties, and to be a potential anti-carcinogen.

athway required in the development of melanoma

and some other types of cancer. Curcumin allowed an induction of apoptosis in

broken skin, may cause a serious skin infection. Both extracts showed antimic

activity, but the effect was enhanced

th

adding lactic acid to the mixture. They suggested that such synergistic ingredients

would be useful for the food industry in food preservation.47

Herbs that Are Cytotoxic to Cancer Cells

As more and more

found to be cytotox

Andrographis paniculata and Uncaria tomentose

Andrographis paniculata (Indian echinacea) has been shown to contain

immunostimulants49, and Uncaria tomentose (cat’s claw) extract has an anti-

proliferative effect on breast cancer cells.50 Further studies have shown that Uncaria

to

immune enhancement effect.51

Scutellaria barbatae

A 2003 study on the Chinese herb Scutellaria barbatae (Scute Barbata) found that it

was cytotoxic to 100% of the actively-proliferating ovarian cell lines tested, and t

52

most lethal gynaecological cancers, and many wom

r reported bal medicine53, it i timely that

explored.

the common sp eric. Studies on

Researchers at the University of Texas M.D. Anderson Cancer Center have shown

that curcumin blocks a biological p


103

me

ab

Rinaldi et al have suggested that curcumin is an oral cavity chemo-preventive agent

ecause of its ability to inhibit carcinogen bioactivation.55 They also suggest that it

va

tum

nnua, (Chinese Wormwood), has been the subject of extensive research,

-malaria treatment. Many forms of malaria have now

orld

oxic drugs, Artemisinin use has resulted in a higher cancer

eath rate.58 When Professor Singh measured apoptosis in MOLT-4 Leukaemia

lanoma cell lines by shutting down a protein (NK-kB) known to induce an

normal inflammatory response.54

b

has anti-tumour, anti-oxidant and anti-inflammatory effects, can induce apoptosis in

rying cell systems56 and, in combination with cisplatin, gives synergistic anti-

our activity.57

Artemesia annua

Artemesia a

primarily for use as an anti

become resistant to the dominant drug treatments, and the search for clinically

effective treatments has centred on Artemisinin, an extract of Artemesia. The W

Health Organisation now suggests Artemisinin as a last resort treatment for malaria.

Artemisinin appears to be effective for more than malarial treatment. Work by

Professor Neranda Singh at Washington University has shown that, when compared

with other types of chemot

cell d

cells, the Artemisinin killed 100% of the cells in 8 hours, as shown in Table 5-1.

Table 5-1: Apoptosis in MOLT-4 Leukaemia Cells

Treatment % MOLT-4 Leukaemia Cells Killed

Time Taken (hours)

(dihydro) Artemisinin (200 μM) 100 8

Sodium Ascorbate (2000 μM) 63 24

Mitoxantrone (0.5 μM) 55 24

Hydrogen Peroxide (176 μM) 40 8

Novobiocin (800 μM) 23 24

X-ray (100 rads) 9.5 24

Hyperthermia (44°C for 1 hour) 5 24

Control 3.4 24

Mistletoe Lectin 1 (Iscador)

In 1653, Nicholas Culpeper, an English Physician, wrote and published The Engl

Physician, a herbal compendium:

ish


104

this early herbal study, Culpeper states that:

an

d has

nsively in European medicine. Proteins extracted from the

oak mistletoe have been shown to be cytotoxic for leukaemia Molt-4 cells in

ix human malignant melanoma cell lines and in human colon cancer

ver, Büssing et al (2003)63 analysed the same melanoma cell

nes as used by Gabius, but was unable to replicate Gabius’s results. In fact they

lectin from the

iscum (mistletoe) plant induced apoptotic death in cancer cells. They showed that

de, an

generated during this process at a cellular level.64

... being an astrologo-physical discourse of the common herbs of the nation; containing a

complete Method or Practice of Physic, whereby a Man may preserve this Body in

Health, or cure himself when sick, with such things only as grow in England, they being

most fist for English Constitutions.59

In

... both the leaves and berries of Misselto do heat and dry and are of subtle parts; the

birdlime doth mollify hard knots, tumours, and imposthumes.

This appears to be the first published reference to mistletoe as a treatment for hum

tumours.

Modern Use of Mistletoe

The re-introduction of mistletoe as a modern cancer treatment came through

Anthroposophical Medicine, based on the writings of Rudolph Steiner 60, an

since then been used exte

culture61, in s

cell lines.62

A study by Gabius et al (2001) suggested that there was a ‘stimulation’ of tumour

proliferation in melanoma and sarcoma cell lines by clinically-relevant low doses of

mistletoe lectin. Howe

li

were not able to show any stimulation of cell growth by the mistletoe extract.

Most research papers on the use of mistletoe have been written in Europe, but

increasingly research is coming from other areas of the world. In 2003, a study of

mistletoe lectin-II (Park et al, 2003, Korea), showed that a particular

V

the lectin induced the production of pro-oxidants causing cellular death, and that

anti-oxidants inhibited this process. They concluded that hydrogen peroxi

oxidising compound, was


105

gh

elines.

ria, where the use of mistletoe (Iscador) was

f 830

ts

ar response rates.

ax

d

igraines. He was successful in his own treatment and went on to trial the

diet with his patients.

in.

r and

ifficult part was patient compliance with extreme dietary change.66

foods

Many other studies have been carried out, especially in European countries, on the

use of mistletoe, but it has seldom been used in conventional oncology in Western

countries. The common rebuttal from conventional oncologists is that not enou

studies have been carried out or that the study designs do not fit the new ‘evidence-

based medicine’ guid

Only one study appears to fit this crite

compared to the standard treatment of interleukins—low-dose recombinant

interferon-alpha 2 b (rIFN-α2b, 1 MU) or recombinant interferon gamma—and

compared to a control group of malignant melanoma patients. A study group o

stage II and III patients at high risk was randomised and followed from 1988 to

199665. This was a well-planned study showing a good success rate, but did not

show any statistical benefit in overall survival for either arm of the trial: patien

assigned Iscadore treatment or the interleukins had simil

Nutritional Medicine

Gerson Diet

An early proponent of nutritional medicine in the treatment of cancer was Dr M

Gerson of Germany, in the early 20th century. Gerson had developed a specific diet

from personal experience, experimenting with changes in his diet to see if he coul

cure his m

He achieved a recovery in a lupus patient with the diet, leading to its use for

tuberculosis patients in the Charité Hospital and later in the Urban Hospital in Berl

When Gerson saw advanced tuberculosis patients with poor prognoses recove

survive he became even more convinced of the benefits of this regime. The most

d

Gerson’s treatments included juices, fresh liver juice, vegetable broths and

high in potassium. He also had his patients use coffee enemas daily as a

detoxification process67.


106

US Senate

committee investigating cancer treatments. He supplied records of successful

orts, X-Rays, five articulate patients, and testimonials from

New

cancer treatment (Moss

999). Following this testimony, the Gerson therapy was reviewed twice in the

ilation of bile ducts to facilitate

excretion of toxic cancer breakdown products by the liver and dialysis of toxic

e colonic wall”.68 The use of coffee enemas

he end

d

partial explanation of why the Gerson diet may have shown efficacy was provided

very strenuous and posed life and death issues for the seriously

s.

erson. The lower quality of our

Dr Gerson emigrated to the USA, and by the 1940s was treating cancer patients with

his largely nutritional approach. In 1946, he was called to testify before a

treatments, pathology rep

many more patients.

Gerson Therapy: Negative Reviews

At the time of Gerson’s testimony, he was in private practice on Park Avenue in

York, with affiliation to Gotham Hospital, NY. The Senate Committee was headed

by Senator Pepper. Although it was not unfriendly towards Gerson, it did not

subsequently recommend a dietary-prevention approach to

1

Journal of the American Medical Association (JAMA): both reviews, perhaps

predictably, concluded that the treatment had no value.

Gerson published an article describing his treatment regime and the rationale for the

diet and the use of caffeine enemas “to cause d

products from the blood across th

seemed to cause derision from the medical profession (Moss 1999). Even at t

of the 20th century, coffee enema treatments were viewed with both concern an

derision.

Explanation of Gerson Therapy

A

by Cope (1978). Cope suggested that such a high potassium and low sodium diet

may have caused damaged cell proteins to return to their normal undamaged

configuration, partly repairing the damage induced in the tissues by the cancer.69

The Gerson diet was

malnourished patient. Many alternative medicine clinics worldwide have

incorporated selected aspects of the Gerson methods into their treatment regime

However, the results achieved today by these dietary changes do not appear to

achieve the high level of success reported by G


107

cu l

Gerson’s time may provide some expl his

Controlled F

Other forms of dietary m

rofessor Ray Kearney of Sydney University studied PAF (platelet-activating

versely,

a w

uniformly susceptible to f nduced

Dr Gavin Greenoak, a colleague of Professor Kearney’s, took the controlled feeding

tudy further. He exposed immune-competent hairless mice to simulated solar

ice were

70

vereating ‘fast’ food

r one month proved to be extremely damaging to Mr Spurlock’s health.

to

ealth issues. Slowly, there is growing concern

sed cancer rates in our society.

r in

rrently avai able foods and increased exposure to environmental chemicals since

anation for t decreased efficacy.

ood Intake

anipulation have been studied in relation to cancer.

P

factor), a pro-inflammatory mediator of lipid metabolism. He found that test animals

that had access to food for only six hours a day—without any reduction in their

normal caloric intake—became resistant to a lethal challenge of PAF. Con

nimals allo ed to graze throughout the day, with continual access to food, were

atal PAF-i anaphylaxis.

s

radiation. Mice allowed access to food for only six hours a day developed 93%

fewer skin tumours than those allowed to graze throughout the day. All m

allowed the same quantity of food.

Lack of Studies on Overeating

The amount of food and frequency of consumption in developed countries is

undoubtedly higher than in previous human history. The size of servings has

increased dramatically, as shown rather graphically in the movie Supersize Me by

Morgan Spurlock (producer and director, 2004). The effect of o

fo

Most Western governments now encourage ‘good’ eating habits in their citizens

minimise obesity and its associated h

regarding a link between overeating and the increa

Therapeutic Foods

Studies have been carried out on specific foods historically associated with a

therapeutic effect. For example, a trial studying the effect of miso (fermented

soybean) with and without Tamoxifen on chemically-produced mammary cance

rats produced the results shown in Table 5-2:


108

Mammary Tumours (Mean Tumours/Rat)

Table 5-2: Effect of Miso and Tamoxifen on Induced Mammary Tumours in Rats

Test Group Incidence of Multiplicity of Tumours

Regular (control) diet 91% 4.5

10% Miso diet 77% 2.4

Tamoxifen 68% 1.4

Tamoxifen + 10% Miso diet 10% 0.2

A second experiment studied the effect of the combination of miso and tamoxifen in

established rat mammary tum

comparing the size of tumours be

ours that had reached a 10–25 mm stage at 6 weeks,

fore and after treatment. See Table 5-3.

Rats Table 5-3: Effect of Miso and Tamoxifen on Established Mammary Tumours in

Test Group Tumour Size at 6 Weeks vs Pre-treatment Tumour Size

Control 160%

Tamoxifen 141%

Tamoxifen + 10% Miso diet 85%

These studies indicate a protective use for miso with mammary cancer and a po

potent antitumour effect, particularly when combined wi

ssible

th tamoxifen.71

ttitudes to Nutritional Supplements by Oncologists

at the use of antioxidants adjunctively

roups—particularly those led by Professor Kedar Prasad at the

Centre for Vitamin and Cancer Research at the University of Colorado, Denver—

ve treatment in combination with radiation therapy.78

A

The use of high-dose nutritional supplements has become widespread amongst many

cancer sufferers. Most oncologists in Australia do not encourage the use of these

supplements during treatment with radiotherapy or chemotherapy. Some oncologists

believe that high-dose antioxidants protect the cancer cells against radiation or

chemotoxic damage, negating the benefits of treatments.72 73 74

However, a large body of evidence indicates th

with chemotherapy has a demonstrated benefit in reduction of tumour size and,

possibly, increased longevity.75 76 77

Studies on Micronutrients in Cancer Treatment

Studies by several g

have shown a sound scientific rationale for a micronutrient protocol. This protocol

included high doses of Vitamin C, Vitamin E succinate and a natural form of く-

carotene, as an adjuncti


109

ished the International Society of Nutrition and Cancer as a

n

u

ent in their modalities.

of

g indicated a beneficial role for

vitamin C in prolonging life expectancy of terminal cancer patients82. This work was

een overwhelmingly ignored or castigated by

availed themselves of these treatments, with or

—of their oncologists. To have

ent ignored for so long is

contradictory to the professed image of open-minded scientific oncology.

treat cancer originated with the work of Dr William B

oley, who was the attending bone surgeon at Memorial Hospital in New York City

Professor Prasad establ

group of clinicians and scientists committed to researching and publishing in this

area.

A recent study from the NIH in the USA showed that high-dose intravenous vitamin

C has a cytotoxic effect and can kill cancer cells79. This group showed that vitami

C leads to the production of hydrogen peroxide in cancerous tissue, inducing the

death of cancer cells.

Intravenous vitamin C treatment has been an area of contention for many years

between conventional and alternative/CAM practitioners. Many patients have been

warned by conventional oncologists of the ‘dangers’ of intravenous vitamin C. A

Sydney newspaper article published in 1994 listed vitamin C under the heading ‘Yo

can Die of the Cure’, though the text stated only that it might cause ‘dietary

irritation’. It seems unlikely at this time that hospital oncology departments in

Australia will include this treatm

The research carried out by Professor Prasad on the benefits of a particular regime

micronutrients has been in published form for many years80 81. Work carried out by

Dr Ewan Cameron and Professor Linus Paulin

published almost 30 years ago and has b

most in the medical establishment.

Despite this, many patients have

without the encouragement—or even the knowledge

a potentially beneficial and inexpensive treatm

Immunotherapy

The use of bacterial toxins to

C

from 1893 until 1936.


110

d of metastatic cancer

espite radical surgery. He reviewed 100 cases of sarcoma treated at Memorial

t

h t normally produces a superficial infection of the skin.

Coley initially injected live culture of S. erysipelas into 10 patients with sarcoma.

at

Revival of Interest in Immunotherapy

There has been a recent revival of interest in this form of immunotherapy. It has

Ü Augmentation of natural killer cell activity,

patients treated with Coley’s toxins to patients treated with modern conventional

Early Work: Dr Coley

Dr Coley has been called by some the father of immunotherapy83 84 85. He developed

an interest in immunotherapy after a young sarcoma patient die

d

Hospital, and found that patients who had developed bacterial infections following

surgery did much better than those who did not. For example, he found a patien

who had four regressions of his cancer following an infection of Streptococcus

erysipelas, a bacterium t a

With repeated injections he found improvement, in some cases without producing the

erysipelas infection, and postulated that toxins from the bacteria might be producing

the tumour reduction activity. He began working with heat-killed bacteria, but the

reactions were initially not as beneficial. Through trial and error, Coley eventually

settled on a more potent mix of gram positive Streptococcus pyogenes and gram

negative Serratia marcescens.86

In 1896, Dr Coley presented a report outlining the benefits of his toxins to cancer

patients.87 For over 40 years, this combination of bacterial toxins was used to tre

patients with a significant degree of success.

been proposed that the mechanism of action of the toxins includes:88

Ü Induction of interferon,

Ü Stimulation of lymphoid tissues,

Ü Activation of macrophages,

Ü Induction of serum factor causing necrosis of tumours and stimulation of

interleukin II (IL-2).

A retrospective study was conducted in 1999, comparing 10-year survival rates of


111

R

nce Epidemiology End Result) cancer registry. The groups were matched

y age, gender, ethnicity, stage and radiation treatment status.

us,

n’ treatment that William Coley

eveloped in the 1890s.89

terested in this case. He

discovered that there had been an outbreak of Newcastle virus amongst the farmer’s

nown bird virus that usually causes no more

wcastle virus vaccine in a 14-year-old boy, first diagnosed

ith Glioblastoma multiforme, was carried out in September 1994. After standard

en

en the MRI

demonstrated progression of the tumour, the chemotherapy regime was changed to a

therapies: 128 of Coley’s cases were matched with 1675 controls from the SEE

(Surveilla

b

The study showed no statistical advantage for the modern day cancer patients. Th

in over 50 years of science, current treatments have not increased the benefit to

patients when compared to the ‘bacterial toxi

d

Anticancer Effect of Newcastle Virus

In Hungary, a chicken farmer, suffering from a metastasised stomach cancer,

suddenly underwent a complete and lasting disappearance of his tumour. The

treating physician, Dr. Laszlo Csatary, became very in

chickens. Newcastle virus is a well-k

than conjunctivitis in humans.

Dr Csatary began investigating whether this ‘spontaneous’ remission could have

resulted from an infection of Newcastle virus. He first published his findings in

197190 and has devoted his life work to developing a treatment using this virus for

chronic disease patients.

Newcastle Virus Vaccine

The anticancer effect of Newcastle virus was first reported in 1965 by Cassell.91 It

has since shown efficacy in the treatment of Glioblastoma multiforme, a highly

malignant brain tumour with a median survival time of one year.

A study on the use of a Ne

w

treatment, consisting of surgical debulking of the tumour followed by radiation

therapy and adjuvant tamoxifen, the tumour had recurred. Chemotherapy was th

given, using cyclophosphamide and vincristine sulphate. Wh


112

ed enlargement of the

astle virus treatment was discontinued. An MRI

ken in September 1998 showed tumour shrinkage of approximately 95%. By

astle Disease Virus), both

children had rapidly progressive cancers despite receiving conventional therapy. At

s, both were shown to have stable tumours, as measured by MRI.

dy, using Newcastle virus as an oncolysate, studied the progression of

tage II malignant melanoma patients. The progression of the disease was

, a

required

A

rmal

Research continues into the use of this vaccine by Csatary and others at the United

ry,97 and by researchers at the

different cocktail. By March 1996, an MRI again show

tumour.

Treatment with Newcastle virus began in April 1996. By January 1997, all

medication apart from the Newc

ta

March 1999 the boy had returned to school.

Two other children with the same form of brain tumour were also given this

treatment. Prior to treatment with NDV vaccine, (Newc

22 and 24 month

They were to continue the NDV vaccine treatment.92

Phase II Study on Newcastle Virus

A Phase II stu

S

considerably less in patients receiving the oncolysate than in the control group.93

The Newcastle virus was found to induce internucleosomal DNA fragmentation

feature of programmed cell death. Only a brief exposure of 30 minutes was

to induce a full-blown apoptotic response.94

This treatment appears to have no significant toxic effects, nor were neurotoxic

effects noted in the glioma patients. For many years Dr Csatary worked in the US

trying to gain acceptance for this treatment. After almost 20 years of unsuccessful

effort, he returned to his native Hungary to produce and trial his vaccine. He has

since returned to the USA, as the use of Newcastle virus vaccine did not gain fo

acceptance in Hungary.95

Cancer Research Institute in Virginia,96 in Hunga

German Cancer Research Center in Heidelberg, Germany.98


113

nvolvement in Cancer, a large body of research

xists on the possible bacterial cause of cancer. Several of the scientists already

lover and Livingston-Wheeler, for example, showed encouraging results with this

yperthermia is a method of treatment based on the premise that cancer cells—even

er

onjunction with low-level chemotherapy, and is

otherapy without an increase in toxic

es of malignant

his treatment was first

sed by Julius Wagner von Jauregg (1857–1940), an Austrian neuropsychiatrist,

yphilis.

of

io o and Medicine for this discovery of the

erapeutic value of fever induction.101

and most well known use of hyperthermia, early in the 20th century, was the

duction of fever by bacterial toxins—the immunotherapy method of Dr Coley,

Other Research on Vaccines from Bacterial Isolates

As discussed in Chapter 4, Bacterial I

e

mentioned had developed and used forms of vaccination, produced from bacteria

isolated from various tumours.

G

form of treatment. Gregory developed several antibiotics as a response to the

organism cultured from tumours, claiming particularly good results in the treatment

of cancer with one antibiotic that he named Gregorcin.

Hyperthermia

H

though they can reproduce indefinitely—are more fragile than normal cells. Canc

cells die at a temperature of around 43ºC, whereas normal cells survive this

temperature.

Hyperthermia is often used in c

believed to increase the efficacy of chem

reactions.99 It has also been shown to improve survival tim

melanoma patients when combined with radiotherapy.100

Many forms of hyperthermia have been used historically. T

u

when treating a patient suffering from dementia paralytica, the final stage of s

He inoculated the patient with malaria. The patient developed the high fevers

malaria, and the fever stopped the progression of the syphilis. Dr von Jauregg

received the 1927 Nobel Prize in Phys l gy

th

Early Use of Hyperthermia in Immunotherapy

The next

in


114

ss

of the immunotherapy fever was the use by mechanical means of

ising the temperature of the tumour. Early methods used microwaves; later

ia.

The patient was placed inside a cylinder containing electrodes that bombarded the

ents with advanced pancreatic cancer had a significant

sponse to the hyperthermia treatment, given in combination with chemotherapy and

rope.

t design is from Professor Andras Szasz of St. Istvan

niversity, Biotechnics Department, Budapest, Hungary.

as are a common brain

mour, usually with a fatal outcome.103 104

itself has been shown to inhibit angiogenesis105, and may induce

anslocation of apoptosis-inducting factor (AIF) and apoptosis in human glioma cell

already discussed on page 109. This technique was also used with apparent succe

by German physician Dr Josef Issels.

An adaptation

ra

methods used infra-red and then radio-wave induction of heat.

Dr Issels gave patients a ‘fever shot’ once a month to raise the body temperature as

high as 105° F (40.5° C). He induced active fever with the drug Pyrifer, made from

specially-treated coliform bacteria. He then induced passive fever by hypertherm

body with ultra short waves.

Studies carried out by Professor Joan Bull at Anderson University in Texas have

examined the use of infra-red hyperthermia using the Heckel Bed from Germany.

She showed that 60% of pati

re

immune-modulating drugs.102

Electro-hyperthermia

The use of ‘oncothermia’ (electro-hyperthermia) appears to be increasing in Eu

The most popular equipmen

U

A recently-published article examined the use of electro-hyperthermia in the

treatment of advanced brain gliomas, alone and in combination with standard

treatments such as chemotherapy or radiotherapy. Gliom

tu

Hyperthermia by

tr

lines.106


115

therapy and

diotherapy,107 and it may help overcome chemo-resistance in human malignant

re-treated with temozolamide-based

hemotherapy and radiotherapy before hyperthermia was applied. One complete and

hat

ECT (Galvanno Therapy)

ent of Karolinska University in Stockholm,

then

eden and met with Professor Nordenstrom. At that

d been

s.

ad

his method of treatment became known as galvanno therapy or Electrochemical

EC-Systems, Nordic Medical Publications, 1998. His work provided a

As an adjunctive treatment in combination with standard therapies, hyperthermia

may well increase their efficacy, enhancing sensitivity to chemo

ra

glioma cells.

A phase II study, published in 2006, was carried out on relapsed malignant glioma

patients in Florence, Italy. Eight patients were p

c

two partial remissions were achieved with a response rate of 25%, indicating t

electro-hyperthermia may have some effectiveness in relapsed glioma cases.108

While head of the Radiology Departm

Professor Bjorn Nordenstrom began working with the concept of treating tumours by

the insertion of fine needle probes into tumours. A low electrical current was

pulsed through the tumour.

In the mid-1980s I travelled to Sw

time, he had used this method to treat 80 lung cancer patients, all of whom ha

treated by conventional means and were considered to be in their terminal stage

Out of these 80 patients, Professor Nordenstrom had reversed the condition of

approximately 28 of them.

Professor Nordenstrom was quick to correct me when I referred to the treatment as

alternative. He was the head of his department and had previously served as the he

of the Nobel Assembly, and felt that the label of ‘alternative’ was an insult to an

established and well-respected scientist.

T

Therapy (ECT).

His study of the electrical currents in the body was published in his book,

Biologically Closed Electric Circuits, Nordic Medical Publications, 1983, and

Exploring BC


116

cientific explanation of the traditional Chinese medical system of acupuncture, and

China and has since spread to several other

vailable to patients in Australia.

omplementary or alternative treatments do

tional practitioners, but rather through

2005 study by Dr Molassiotis, on haematological cancer patients from 12

ngland presented particularly different results. He stated in his

003 paper111 that most cancer patients received information on non-conventional

pean (British) cancer patients, as

e

T ust When They or Their Loved Ones are Sick, from Pew

8% of

experimental

s

it became widely used by those practicing oncology in China.

Professor Xin Yuling, Head of Thoracic Surgery at the China-Japan Friendship

Hospital in Beijing, adopted this method of treatment. Professor Xin published many

large studies showing the efficacy of this treatment, and by the early 2000s over 1200

hospitals in China were using the ECT method.

The use of ECT has continued in

countries. A small number of Australian patients have travelled to China for

treatment but as yet, this treatment is not a

Patient Choices and Information

Most cancer patients who decide to use c

not do so on the advice of their conven

information from a variety of other sources.

Sources of Information on CAM

A

European countries, found that their main sources of information were friends,

family and the media.109 This study confirmed earlier research (2002) on the

sourcing of information relating to non-conventional forms of treatment.110

Professor Ernst in E

2

therapies from newspapers, books and, increasingly, the Internet. Interestingly,

Professor Ernst sourced his information from Euro

did Dr Molassiotis.

Walji et al (quoting Fox and Rainie, in Vital Decisions: How Internet Users Decid

What Information to r

Internet and American Life Project, Washington, DC (2002)112 suggests that 4

health-related Internet searches are for information about CAM or

treatments.


117

rent therapies, especially herbal medicines, but should

lso increase their knowledge and understanding of CAM therapies so that they can

Common Choices of Therapy

A study on the use of CAM treatments in 126 colorectal cancer patients found that

the most commonly used therapies were:

Ü Herbal medicine (48.7%),

Ü Homeopathy (20.5%),

Vitamins and minerals (17.9%),

Ü Spiritual therapies (15.4%),

tion techniques (12.8%).

an countries and showed that 87% of

ent, and that of this group, 89% underwent

its use was effective. Only two of the 126 patients reported no benefit from their use

the possible benefits

f alternative/CAM treatment in cancer patients.

her

ed in, their own treatments,

Ü To increase their sense of well being and decision making,

Ü To increase their own level of hope as to a positive outcome.

The above papers show a significant difference in patients’ methods of sourcing

information. However, there is general agreement that medical practitioners, be they

oncologists, radiotherapists or surgeons, should not only be aware of possible

interactions between the diffe

a

offer informed and unbiased information to their patients.

Ü

Ü Medicinal teas (15.4%),

Ü Relaxa 113

This study was conducted across seven Europe

the patients received conventional treatm

chemotherapy. Most patients reported satisfaction with the use of CAM and felt that

of CAM therapies.

There have been many conflicting studies published concerning

o

Demographics of CAM Users

A study by Richardson et al (2000) cited several reasons for patients to use ot

forms of treatment: 114

Ü To attempt to control, or at least be involv


118

ound that

d less than 10,000 GBP annually,

Ü The most commonly used type of treatment was homeopathy (39%) followed

at

he choice of homeopathy may reflect the long history of its use in Europe and its

nts 2 and 3 amongst the patients in this

Molassiotis et al (2005) found that patients with colorectal cancer who chose to

incorporate CAM techniques into their treatment regime tended to be younger, with

non-manual jobs, and were most likely to have received previous conventional

treatment for their cancer.115

The 2005 study by Molassiotis on patients with haematological cancers f

CAM users were from a variety of backgrounds: 116

Ü 30% were in professional jobs,

Ü 22% were university educated,

Ü 28% were manual workers,

Ü 25% were retired,

Ü 76% were married,

Ü They generally earne

by psychic therapies (use of mediums/healers) and herbal medicines, both

22%,

Ü A quarter of the herbal usage was with mistletoe.

T

ease of access. The most common reasons for CAM use given by patients were:117

Ü To increase the body’s ability to fight the cancer,

Ü To improve physical well-being,

Ü To improve emotional well-being, hope and optimism.

There was a 44% perception of benefit for poi

study, but it was not within the scope of the study to judge whether benefit was real

or merely perceived. Molassiotis states “It is interesting to see that spiritual

therapies (such as faith healing, Reiki or prayer) have been frequently reported in

the literature as being used by cancer patients.”


119

ty rayer would

or suggests, somewhat surprising.

ients

ent

ncrease in levels of hope.118 It is

teresting that the range of CAM practitioners discussed in the study did not include

an

.

5-year follow-up of the long -term benefits of CAM treatments did not show

ve in this

roup of CAM users.

howed

death rate of patients using these treatments. However, the study

ointed out that the use of CAM treatments was more common among patients with

ts

he authors of the study did not feel that the use of CAM treatments directly

ms

g st a more aggressive disease, hence their turning to other treatments in an

attempt to alleviate suffering.

Interest in Prayer and Spirituality

Having worked with many cancer patients over the past 20 years, I think most

patients who face death tend towards some form of spirituality and prayer. I would

suggest that for most people—when faced with their own mortali —p

be a natural choice rather than being, as this auth

Patients with More Aggressive Cancers More Likely to Choose CAM

Another study that examined patients with a broad range of cancers (127 pat

from three centres in Scotland and England) found similar results. An improvem

of physical well-being was reported by 44% of patients, whereas 67% reported an

improvement in emotional well-being and an i

in

‘holistically-trained’ medical practitioners and that, in most cases, no practitioners

were involved in the choice of treatments, treatments were patient driven rather th

practitioner recommended

A

increased survival rates among CAM users in this particular study.119 However, the

authors of the study stated that this could be because disease was extensi

g

A Norwegian study of the survival rates of patients using CAM techniques s

an increase in

p

symptoms relating to their cancer, those receiving only palliative treatment, patien

with metastatic disease and those diagnosed with cancer more than three months

previously.

T

influenced survival times, but that patients who turn to these treatments may have

suffered worse symptoms during cancer treatment. The more severe sympto

might su ge


120

ies brought psychological

ally

y and a

with conventional treatments.120 121

aediatric Patients Choosing CAM Therapies

e form of CAM

ent, with the most common therapies being multivitamins, aromatherapy,

n CAM usage by children with cancer. In a study

, only 9% of parents indicated that they had used some other

124

366 patients showing that 42% had used some form of CAM therapy.125

ncer had a lower survival chance; 46% of children

using these therapies had suffered a relapse, whereas only 16% of children in

e form of adjunctive treatment in

Patients have reported that their use of CAM therap

benefits—being more optimistic about the future, feeling calmer and emotion

stronger—and an improvement in their physical well-being, with more energ

reduction in the nausea associated

P

A study on the use of CAM treatments amongst paediatric patients in the United

Kingdom122 showed that 33% (of 49 respondents) used som

treatm

massage, diet and music therapy. These therapies played a substantial role in helping

the children through conventional treatments.

There has been a marked increase i

123published in 1977

kind of therapy. By 1994 , a publication from Australia showed an increase in this

level of use to 46%.

This trend in increased use appears in other countries also, with a Canadian study of

A study from the USA in 2000 showed that 84% of children with cancer were

receiving at least one type of CAM therapy while undergoing conventional

treatment.126

From the Netherlands, Grootenhuis et al (1998)127 showed an increased usage of

CAM therapies if the child with ca

remission used such therapies.

The highest reported use of CAM therapies (sourced to date) in childhood cancer

treatment is of 73% of patients using som

Taiwan.128


121

age

were

se

edicine133 134, and that 40% of those were being treated

135 05

Oncology Practitioners

ough studies have shown that most CAM

h

gists’ knowledge and attitudes

py

Adult Cancer Patients Choosing CAM Therapies

For adult cancer patients, studies from the UK estimate that the use of CAM

therapies ranges from 32% in patients undergoing radiotherapy129 to 16% in

unselected oncology patients.130

Five studies undertaken in Turkey since 1998 showed that CAM treatment us

ranged from 39% to 60%, with the most commonly used therapy being herbal

medicine.131

An Israeli study showed that approximately one-third of adult cancer patients

surveyed used CAM treatments. Most patients were satisfied with the results and the

effect achieved by these therapies, and the authors noted that no adverse effects

reported from these treatments.132

In Australia, it has been reported that 22% to 52% of medical oncology patients u

non-conventional m

palliatively. As this last figure was published in 1993, the true percentage in 20

will be much higher if Australia follows world-wide trends.

Attitudes and Understanding of

On the whole, conventional cancer specialists appear to have a very negative

approach to CAM therapies. Even th

therapies are used to assist with the often debilitating and horrific side-effects of

conventional treatments, and that reports of interactions of CAM therapies wit

conventional treatments have been reported only rarely136, many practitioners still

have a strong distrust of their use.

Oncologists Surveyed on CAM Therapies

A study published in 2000 surveyed Australian oncolo

about the CAM therapies used by cancer patients. Of the 265 surveys posted out,

161 oncologists responded as follows:137

Ü Oncologists reported knowing most about acupuncture, antioxidant thera

and meditation.


122

as no

explanation of the reason for concern for the use of Iscador therapy, but it

re was a distinction between therapies being used for palliative as

compared to curative treatment, with acupuncture and the psychosocial

eatments that may have anti-cancer effects.)

ists overestimated the use of CAM therapies amongst

herbal

omeopathy, magneto-therapy and shark cartilage

therapy.

anced cancers.

Ü Even though a large number of the oncologists considered that they had a

n

ote that this study used self-reporting rather than any objective assessment of the

non-

onventional treatments once no hope is left for the patient, when the patient is in

Ü The therapies considered most likely to be harmful were coffee enemas,

psychic surgery, Iscador therapy and diet therapies. (There w

may be because of the injectable nature of the treatment or the perceived

possibility of it having anticancer effect.)

Ü The

therapies considered helpful for palliative patients.

Ü A higher level of harm was feared from the use of therapies that might

actively affect the cancer itself. (Note the distinction between ‘soft’ and

‘alternative’ treatments. The soft treatments do not actually target the tumour,

as opposed to alternative tr

Ü Many of the oncolog

palliative patients, particularly the use of aromatherapy, coffee enemas,

therapies, naturopathy, h

Ü The therapies that oncologists reported knowing most about—meditation,

relaxation, visual imagery and antioxidants—were the therapies most used by

their patients.

Ü The patients likely to use non-traditional therapies were those with the most

adv

good knowledge of the use of antioxidants, there still appears to be no

standard use in Australia of antioxidant/micronutrient therapy in combinatio

with conventional treatments.

N

oncologists’ actual knowledge about these therapies.

Lack of Understanding of CAM Therapies

This survey of oncologists appears to indicate an acceptance of the use of

c


123

nts

’

ls, available through

ubMed.

t read?

e

than with hard science?

rnals against

tion

best, these articles showed a

lack of understanding of th

mi

Pr

on n orthodox treatment, the other as an

nconventional treatment—received quite different responses from journal

palliative care. The hostility shown, even with no understanding of the treatme

used, is not a particularly scientific stance.

Many of the treatments described by this particular group of oncologists as ‘harmful

have been validated by research published in refereed journa

P

Is it a question of scarcity of time in busy practices, so research papers are no

Could the attitude be that if these treatments were acceptable we would all be using

them, so it would be best to wait until all oncologists embrace these treatments?

Could the belief patterns of Australian oncologists have more to do with an emotiv

response

Bias in Medical Journals

The evidence indicates a strong bias in conventional medical jou

alternative forms of treatment.

Two articles on complementary and alternative medicine were published in 1998 in

leading medical journals. One was an editorial on the risks of alternative medicine,

published in the New England Journal of Medicine (NEJM), and the other a study on

‘therapeutic touch’, published in the Journal of the American Medical Associa

(JAMA).

An evaluation was undertaken as to whether the information and opinions presented

in these articles were objective. It was found that, at

e concepts of alternative medicine. At worst,

sinformation was regarded as a possibility.138

ofessor Ernst of Exeter University in the UK showed that two identical papers—

e listing the treatment discussed as a

u

reviewers. The manuscripts referred to a study on treatment for obesity.


124

r the paper should be accepted or rejected. The response

about the ethics of the reviewing

rocess, with its apparent prejudice against alternative interventions. It also

ted by orthodox medicine. What has been viewed as

Ü The efficacy of CAM therapies as stand-alone therapies,

icular,

etween herbal therapies and chemotoxic drugs

should be examined. For example, St John’s Wort, a herb often used for mild

ion, lowers levels of the chemotoxic drug irinotecan, reducing

We conclude that acupuncture continues to be associated with occasional, serious adverse

o

, Director of the Morley Acupuncture

Clinic and Complementary Therapy Centre at West Yorkshire, pointed out that:

Ernst recruited 398 reviewers via Medline searches to receive one or the other

version of the paper. The reviewer graded the paper as (a) 1 – 5 in level of

importance and (b) whethe

rate was 41.7% (141) of reviewers. When responses were compared, Ernst found a

significant difference in favour of the ‘orthodox’ version.139

Such a response from reviewers raises questions

p

highlights the difficulties in producing and publishing good science for any method

outside the standard usage accep

paranoia by alternative practitioners may be the truth regarding current scientific

attitude.

Studies must be funded to fully investigate:

Ü The use of CAM therapies as adjunctive therapies,

Ü Possible detrimental interactions with conventional treatments. In part

the potential for interaction b

depress

effectiveness of the chemotherapy regime.140

Bias Against Acupuncture

A paper entitled “Acupuncture may be associated with serious adverse events” was

published in the British Medical Journal141, stating:

events and fatalities. These events have no geographical limits. Most of these events are

due to negligence. Everyone concerned with setting standards, delivering training, and

maintaining competence in acupuncture should familiarise themselves with the lessons t

be learnt from these untoward events.

A letter of response from John Heptonstall


125

ents.

this

ow Western Infirmary, had

examined the literature regarding acupuncture in 1994–5 and had stated that:

and

Ü A general practitioner practicing acupuncture was able to treat after 250 hours

ch was TCM/acupuncture.143

members of the conventional medical community as an

d scientific medicine by charlatan’s methods. These methods

may pose as medical treatments but lack medical usefulness or scientific validity, and

Be

ies of holistic medicine, research sites and associated government

Ü In 55,000 treatments using acupuncture there had been 44 adverse ev

When compared to the level of adverse events in conventional medicine,

result is miniscule.

Ü Dr Kim Jobst, Honorary Research Fellow at Glasg

“of the comparatively few ADRs to acupuncture most of these were associated

with doctors practicing acupuncture.”142

In the same discussion it was pointed out by Sean Walsh, a post-graduate student

acupuncturist, that in Australia:

of practice.

Ü An alternative practitioner of acupuncture and TCM had to achieve a

minimum of 2500 hours, 1500 of whi

This would indicate that a medical doctor trained in conventional medicine receives

less education to practise outside their field than do alternative practitioners,

sometimes with regrettable results.

Quackwatch

CAM is viewed by some

attempt to replace goo

exist only to take money from the innocent public. CAM is often considered to be

lacking in critical thought and scientific rigour, and is often referred to as ‘quackery’.

A web site of the Lake Macquarie City Council (in NSW) states that one should “

aware that alternative health and healing covers everything from pure hogwash to

promising and proven therapies.”144 This web site then gives links to web sites of

various modalit

sites.


126

he first link shown is to a US site called ‘Quackwatch’, describing it as a

is

n of Claims of the

aranormal. Quackwatch and other related sites show Dr Barrett’s involvement in

ne, including the article titled High Doses of Vitamin C

re Not Effective as a Cancer Treatment.

h (NIH)145,

n C against cancer is

iscussed on page 108.)

to similar sites, including the Australian

tbagsDotCom site. These sites are

ely critical of alternative and complementary therapies, but do not list any

imes or ADRs (Adverse Drug Reactions).

Conclusions

m of

s.147

T

“consumer guide to health fraud, quackery, and intelligent decision making on

traditional and alternative health topics.” This description is taken from the

Quackwatch site itself, a site run by Dr Stephen Barrett.

Dr Barrett is the vice-president of the National Council Against Health Fraud, and

a Fellow of the Committee for the Scientific Investigatio

P

several court cases, as an expert witness giving evidence against practitioners of

alternative medicine (see also www.bolenreport.net).

Dr. Barrett’s Quackwatch web site, has articles deriding most forms of alternative

and complementary medici

a

The recent publication of a study from the US National Institutes of Healt

showing that intravenous vitamin C does kill cancer cells, has not prompted the

withdrawal of Dr Barrett’s article. The kindest explanation is that the web site is not

updated frequently enough to remove articles once scientific studies have validated

the claims of CAM therapies. (The use of high dose vitami

d

Australian Skeptics

In Australia, a group called the Skeptics146 has the stated aim of investigating

subjects such as paranormal and pseudo-science (which includes vitamin

supplements). Their web site provides links

Council Against Health Fraud and the Ra

extrem

articles querying dangerous drug reg

With approximately one-third of cancer patients world-wide now using some for

complementary or alternative treatment, it is imperative that researchers investigate

fully both the benefits and disadvantages to patients of these treatment


127

y this cohort of cancer patients, it

nosed with cancer, but

r

e therapy.

of toxicity (post chemotherapy), a seriously

d

e

easonable state of health.

n turn to alternative treatments as a last

cant and

b

In the papers referred to above, most authors agree that the main use of CAM

therapies amongst cancer patients is by:

Ü Patients in palliative care, when their conventional treatments have been

unsuccessful.

Ü Patients who are seeking higher levels of pain control than others, perhaps

indicating more advanced or serious conditions.

When treatment by CAM therapies is sought b

should be expected that any form of non-conventional treatment has less likelihood

of success. These are not patients who have just been diag

ather patients who have already undergone chemotherapy, radiotherapy, surgery

and/or hormon

Such a patient may have elevated levels

epleted immune system (from chemotherapy, radiotherapy and surgical

intervention) and a tumour that has been changed by chemotherapy and radiotherapy

from the original cancer that was diagnosed. The response from such a patient will

always be different to the response of a patient at first diagnosis who, apart from th

cancer, is more likely to be in a r

To compare the results of treatments on such differing cohorts of patients is likely to

be biased, unrealistic and unscientific. For patients who have already undergone

standard conventional treatment and who the

resort, any benefit from that treatment should be viewed as a signifi

eneficial result.

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108 Fiorentini G, Giovanis P, Rossi S, Dentico P, Paola R, Turrisi G & Bernardeschi

phase II clinical study on relapsed malignant gliomas treated with electro-hyperthermia', In Vivo

20(6A): 721-24.

109 Molassiotis A (2005), 'Complementary and alternative medicine use in patients with

haematological malignancies in Europe', Complementary Therapies in Clinical Practice 11(2)

10.


135

an

stam F, Johnson C & Bernstam E (2005), 'Searching for cancer-

matics 74(7-8): 685-93.

ey N (2005), 'Complementary and

gy 18(13): 2505-14.

i

e medicine use in colorectal cancer patients in seven European countries', Complementary

5-

edicine in patients with cancer: A UK survey', European Journal of Oncology Nursing

e of nonproven

PD, Arnott SJ, Lister TA & Slevin ML (1994),

ent',

, Hanson J & Bruera E (200), 'Complementary therapy use: a survey of community

alternative

Ballentine R, Ballentine L & van Eys J (1977), 'Unproved cancer remedies. A survey of

native

therapies by children with cancer', The Medical Journal of Australia 160(6): 320-22.

110 Shen J, Andersen R, Albert PS, Wenger N, Glaspy J, Cole M & Shekelle P (2002), 'Use of

complementary/alternative therapies by women with advanced-stage breast cancer', BMC

Complementary and Alternative Medicine 2: 8.

111 Ernst E (2003), 'The current position of complementary/alternative medicine in cancer', Europe

Journal of Cancer 39(16): 2273-77.

112 Walji M, Sagaram S, Meric-Bern

related information online: Unintended retrieval of complementary and alternative medicine

information', International Journal of Medical Infor

113 Molassiotis A, Fernandez-Ortega P, Pud D, Ozden G, Platin N, Hummerston S, Scott JA, Panteli

V, Gudmundsdottir G, Selvekerova S, Patiraki E & Kearn

alternative medicine use in colorectal cancer patients in seven European countries', Complementary

Therapies in Medicine 13(4): 251-7.

114 Richardson MA, Sanders T, Palmer JL, Greisinger A & Singletary SE (2000),

'Complementary/alternative medicine use in a comprehensive cancer center and the implications for

oncology', Journal of Clinical Oncolo

115 Molassiotis A, Fernandez-Ortega P, Pud D, Ozden G, Platin N, Hummerston S, Scott JA, Pantel

V, Gudmundsdottir G, Selvekerova S, Patiraki E & Kearney N (2005), 'Complementary and

alternativ

Therapies in Medicine 13(4): 251-7.

116 Molassiotis A (2005), 'Complementary and alternative medicine use in patients with

haematological malignancies in Europe', Complementary Therapies in Clinical Practice 11(2): 10

10.

117 ibid.

118 Scott JA, Kearney N, Hummerston S & Molassiotis A (2005), 'Use of complementary and

alternative m

9(2): 131-37.

119 Risberg T, Lund E, Wist E, Kaasa S & Wilsgaard T (1998), 'Cancer patients us

therapy: a 5-year follow-up study', Journal of Clinical Oncology 16: 6-12.

120 Downer SM, Cody MM, McClusky P, Wilson

'Pursuit and practice of complementary therapies by cancer patients receiving conventional treatm

British Medical Journal 309: 86-89.

121 Oneschuk D

and hospital based patients with advanced cancer', Palliative Medicine 14: 432-34.

122 Molassiotis A & Cubbin D (2004), ''Thinking outside the box': complementary and

therapies use in paediatric oncology patients', European Journal of Oncology Nursing 8(1): 50-6.

123 Faw B,

use in pediatric outpatients', The Journal of the American Medical Association 238: 1536-38.

124 Sawyer MG, Gannoni AF, Toogood IR, Antoniou G & Rice M (1994), 'The use of alter


136

logy patients in British Columbia: prevalence and reasons for use and

f

er', Journal of Pediatric

nt

n

: 55-65.

Wilson PD, Arnott SJ, Lister TA & Slevin ML (1994),

'Pursuit and practice of complementary therapies by cancer patients receiving conventional treatment',

British Medical Journal 309: 86-89.

131 Algier LA, Hanoglu Z, Ozden G & Kara F (2005), 'The use of complementary and alternative

(non-convention) medicine in cancer patients in Turkey', European Journal of Oncology Nursing 9(2):

138-46.

132 Pud D, Kaner E, Morag A, Ben-Ami S & Yaffe A (2005), 'Use of complementary and alternative

medicine among cancer patients in Israel', European Journal of Oncology Nursing 9(2): 124-30.

133 Begbie SD, Kerestes ZL & Bell DR (1996), 'Patterns of alternative medicine use by cancer

patients', The Medical Journal of Australia 165: 545-48.

134 Miller M, Boyer MJ, Butow PN, Gattellari M, Dunn SM & Childs A (1998), 'The use of unproven

methods of treatment by cancer patients: frequency, expectations and cost', Supportive Care in Cancer

6: 337-47.

135 Yates PM, Beadle G, Clavarino A et al (1993), 'Patients with terminal cancer who use alternative

therapies: their beliefs and practices.' Sociology of Health & Illness 15(199-216).

136 Kelly KM (2004), 'Complementary and alternative medical therapies for children with cancer',

European Journal of Cancer 40(14): 2041-46.

137 Newell S & Sanson-Fisher RW (2000), 'Australian oncologists' self-reported knowledge and

attitudes about non-traditional therapies used by cancer patients', The Medical Journal of Australia

172: 110-13.

138 Eskinazi D & Muehsam D (1999), 'Is the scientific publishing of complementary and alternative

medicine objective?' Journal of Alternative and Complementary Medicine 6: 587-94.

139 Ernst E (2000), 'Are reviewers biased against unconventional therapies?' The Scientist, 30 October,

14(21): 6.

140 Mathijssen RHJ, Verweij J, de Bruijn P, Loos WJ & Sparreboom A (2002), 'Effects of St. John's

wort on irinotecan metabolism', Journal of the National Cancer Institute 94: 1247-49.

125 Fernandez CV, Stutzer CA, MacWilliam L & Fryer C (1998), 'Alternative and complementary

therapy use in pediatric onco

nonuse', Journal of Clinical Oncology 16: 1279-86.

126 Kelly KM, Jacobson JS, Kennedy DD, Braudt SM, Mallick M & Weiner M (2000), 'Use o

unconventional therapies by children with cancer at an urban medical cent

Hematology/Oncology 22: 412-16.

127 Grootenhuis MA, Last BF, de Graaf-Nijkerk JH & der Wel M (1998), 'Use of alternative treatme

in pediatric oncology', Cancer Nursing 21: 282-88.

128 Yeh C, Tsai J, Li W et al (2000), 'Use of alternative therapy among pediatric oncology patients i

Taiwan', Pediatric Hematology and Oncology 17

129 Maher EJ, Young T & Feigel I (1994), 'Complementary therapies used by patients with cancer

(letter)', British Medical Journal 309(6955): 671-72.

130 Downer SM, Cody MM, McClusky P,


137

1

Ernst E & White AR (2000), 'Acupuncture may be associated with serious adverse events', British

edical Journal 320: 513.

Jobst K (1998), 'Here's Health', Therapy Update, July 1998: 28.

3 Walsh S (2000), 'An 'alternative's' response', British Medical Journal: Rapid Responses.

4 (2005), 'Alternative Medicine', Lake Macquarie Health, viewed 2005,

http://www.lakemac.infohunt.nsw.gov.au/library/links/inform/Health/alternat.htm>.

5 Chen Q, Espey MG, Krishna MC, Mitchell JB, Corpe CP, Buettner GR, Shacter E & Levine M

(2005), 'Pharmacologic ascorbic acid concentrations selectively kill cancer cells: action as a pro-drug

to deliver hydrogen peroxide to tissues National Academy of Sciences of the

United States of America 102(38):

146 (2005), 'The Australian Skeptics', viewed c ber 2005, <http://www.skeptics.com.au/>.

147 Ernst E & Cassileth BR (1998 entary/alternative medicine in cancer:

a systematic review', Cancer 83:

14

M

142

14

14

<

14

.' Proceedings of the

13604-09.

14 De em

), 'The prevalence of complem

777-82.


138

PART III

ECONOMICS

Changes in Cancer Research: Research Findings, Economics, Philosophy Jennie Burke – April 2007 Chapter 6 – Following the Money

Chapter 6

139

Following the Money

responsible. I can't blame a businessman

who goes to Washington and tries to get special privileges for his company. That’s his

business. He has been hired by his stockholders, as it were, to make as much money for

it.

Few trends could so thoroughly undermine the very foundations of our free society as the

f a social responsibility other than to make as much

with a

arch. In this chapter, I

xamine:

Th

un reet’. To gain some concept of how this has

h of those corporations that have come to

be known as ‘Pharma’.

ompanies, such as I.G. Farben in Germany and the Standard Oil Company in the

USA (owned by the Rockefellers). By 1927, Farben and Standard Oil had formed a

As a believer in the pursuit of self-interest in a competitive capitalist system, I am not

going to bash business for not being socially

them as he can within the rules of the game. And if the rules of the game are that you go

to Washington to get a special privilege, I can't blame them for doing that. I'm going to

blame the rest of us for being so stupid and foolish as to let them get away with

Milton Friedman1

acceptance by corporate officials o

money for their stockholders as possible.

Milton Friedman2

The incidence of cancer has increased world-wide throughout the 20th century,

corresponding increase in the monies invested in related rese

e

Ü The monies associated with treatment and research,

Ü Recipients of the monies generated in cancer research,

Ü Contributors to the funding and the science.

Growth of Pharmaceutical Companies

e amount of money involved in cancer research and treatment is beyond the

derstanding of ‘the man in the st

happened, this discussion follows the growt

The beginning of the 20th century saw the burgeoning of the new chemical

c


140

pany in the world. They then

eld interests in American I.G. Chemical, Lederle Laboratories, Sterling Drug,

ealth and Power of Pharma

o

educational institutions.

o the Fortune

500 analysis of businesses in the USA in 2000,

past few decades. According to David Earnshaw, a former director of SmithKline

Beecham and now leader of Oxfam’s campaign

Put toget market capitalization e four largest (pharmaceu mpanies is

more than the economy of India.4

Excessive Profits on Prescription Drugs

In 2001, the 11 top US pharmaceutical companies showed rates of profit that were

three to fou than the med f all other stries listed in Fortune 500.

cartel agreement, whereby the two companies did not compete with each other, but

agreed to mutually develop and exploit new scientific breakthroughs.

By the 1940s, I.G. Farben was the largest chemical com

h

Winthrop Chemical, Hoffman-La-Roche, Bristol Myers, and Squibb and Sons

Pharmaceuticals.3

By the end of World War II, General Eisenhower reported that I.G. Farben had stock

interests in 613 corporations, 173 of them in foreign countries. When I.G. Farben

was dismantled in 1946, some sections—such as Bayer, Hoechst and BASF—

survived in Germany, whereas others were absorbed internationally into the

Rockefeller empire.

W

Pharmaceutical companies have become among the richest, most influential

businesses in the world, wielding enormous political power through their effects on

national economies and their use of lobbyists and political donations. Their ability t

fund medical research has strongly influenced the direction and the dominant

paradigms in medical research and

Pharmaceutical companies are among the most profitable businesses in the world.

Their worth puts them into the number one or two ranking according t

a rank that has been consistent for the

on access to medicines:

her, the of th tical) co

r times more ian o indu


141

Pfizer has s ease in stock s over the decade of 1,454%. In 2000,

erck, the the US drug com ies, made profits of US $6.8 billion, giving

roduction, metals and hotel/casino/resorts industries.

oney. A US Congress report from the Office of

Technology Assessment (OTA) stated that the pharmaceutical companies were

making excessive profits on prescription drugs

a proportion of this o ion. The ed th 983 New

Chemical Entities (NCE’s) delivered cash fl of US $341 m n per compound.

The net after-tax value of the cash flows for these NCE’s was $230 million.6 The

report stated t revenue and cost assumptions were very uncertain as

they knew little about cash flows from global sales.

The Pharmace rers Association estimated that worldwide drug sales

.7%

ov r-

the with a market

share in the USA of $43 billion.7

000

hown an incr price last

M largest of pan

it higher returns than the combined profits of the airline, entertainment, food

5p

In the early 1990s, it was becoming obvious that the pharmaceutical manufacturers

were making astounding sums of m

, and that they were spending too high

n promot OTA estimat at the 1981–1

ows illio

hat the figures for

utical Manufactu

by US pharmaceutical companies in 1992 was $75.2 billion, an increase of 11

er 1991 sales. Global sales of ‘ethical’ pharmaceuticals—prescriptions and ove

-counter medications—were said to have been $63 billion in 1991,

The sales and profits of some of the larger pharmaceutical companies for 1999, 2

and 2001 (depending on availability of data) are shown in Table 6-1.

Table 6-1: Profits by US Pharmaceutical Companies

COMPANY YEAR SALES (in US$ billion)

PROFIT (in US$ billion)

Abbott 2000 13.7 2.8

Amgen 2000 3.6 N/A

AstraZeneca 2001 16.5 4.2

Aventis Group 2001 5.8 N/A

Baxter 2000 6.8 N/A

Bayer 1999 8.9 N/A

“ “ 2001 10.1 N/A

Bristol-Myers Squibb 2000 20.0 4.7

GlaxoSmithKline 2001 24.8 N/A

Immunex 1999 0.542 N/A

Novartis 2001 19.1 4.2

Pharmacia Group 2000 18.1 N/A


Schering-Plough 2001 9.8 N/A

Sicor Group 2001 0.370 N/A

Not

Cla

In rtune magazine listed the world's largest corporations showing their

steady increase in revenue over the 2001 to 2002 period. The figures in Table 6-2

crikey.com:

(in US$ billion) (in US$ billion)

e: The figures above are in US dollars, and are sourced from District Court documents of Massachusetts in the

ss Action against Multiple Pharmaceutical Companies (Civil Action: 01-CV-12257-PBS).

July 2003, Fo

are taken from www.

Table 6-2: Profits by World’s Largest Pharmaceutical Companies

COMPANY 2002 PROFIT 2002 REVENUE

Pfizer (USA) 3.9 45.9

GlaxoSmithKline (Britain) 7.45 35.0

Bayer (Germany) 1.5 32.3

Novartis (Switzerland) 5.0 24.9

Roche Group (Switzerland) 2.3 23.2

Merck (USA) 6.8 22.5

Bristol-Myers Squib (USA) 3.1 20.9

Aventis (France) 2.2 20.2

AstraZeneca (Britain) 3.0 18.9

According to Harvard Business School Professor Debora Spar, corporations:

...are not institutions that are set up to be moral entities… They are institutions wh

have really only one mission, and 8

ich

that is to increase shareholder value.

fore protected as sources of major value.

obal sales worth of more than US $73 billion per year.

owever, only 14 new blockbuster drugs were expected to acquire patents in 2006.9

therapeutic standbys, whose numbers grew at a much slower rate ... Many of the new

Importance of Patents

The research and development costs associated with bringing a new drug to the

marketing stage are high. The ownership of a patent gives a pharmaceutical

company the length of time needed to recoup its investment. Purchasing patents

gives a company the ability to supply a drug with no competition—if it is a novel

entity—for years. Patents are there

Between 2002 and 2007, it is estimated that 35 patents will expire for drugs that

currently have an aggregate gl

H

After 1899, the flood of new drugs continued to rise for half a century. Few of these

turned out to be safer, more effective, and cheaper than well-known and long-tested

142


143

y

ubstances constitute

valuable contributions to the pharmacopeia used in primary care ... Opinions vary about

umber of useful drugs; some experienced clinicians believe that less than two

tion.

e current examples of costly drugs (prices given in US dollars) are as follows11:

years.

tment of chronic myeloid

leukaemia, costs more than $500 per month.

Ü For patients in the USA who have health insurance, a standard regime for

s of

stance

anies donate free cancer drugs each year—and

Ü The older chemotoxics are not necessarily much less expensive. An eight-

elp pay for future drug development and clinical trials. A spokesperson for Bristol-

drugs (after WWII) were dangerous, and .... few were demonstrably better than those the

were meant to replace. Fewer than 98 percent of these chemical s

the actual n

dozen basic drugs are all that will ever be desirable for 99 percent of the total popula

Ivan Illich10

Cost of New Drugs

With the development of new drugs that appear to extend lives and are less toxic than

those routinely used in standard chemotherapy, the cost to consumers is a growing

issue, at least in the USA.

Som

Ü Iressa, used in the treatment of lung cancer, costs approximately $1,800 per

month. Patients may need to take the treatment for many months, if not

Ü Gleevec, taken for long periods of time in the trea

Ü Erbitux, used in the treatment of advanced colorectal cancer, costs from

$18,000 to $30,000 for a seven-week course, perhaps longer if patient

response is favourable.

advanced colon cancer would cost close to $250 000 for 19–20 month

treatment. The patient would be expected to pay 20% of this cost—around

$50 000. Patients without health coverage may apply for a patient assi

scheme—to which drug comp

hope they will be accepted.

week course of Irinotecan (an older class of chemotoxic) would cost close to

$9,500.

When these high prices are queried, the response from the industry is that the prices

h

Myers Squibb stated, for example, that the price of Erbitux would fund 60 trials


144

rer of

be

was

und to be effective in the treatment of multiple myeloma and other cancers. The

nt for colorectal cancer was Fluorouracil (5-FU)

vastin—costs almost $250 000.

price cannot be put on months of life. However, a gain of another 8 to 11

he loss of a patent—with the resultant rapid decrease in income—is a huge issue for

Pfizer is to create new drugs with

ng patent times in which to recoup their investment.

involving Erbitux. According to a spokesperson for AstraZeneca, manufactu

Iressa, these prices are “in line with other cancer treatments”.

Fair Price?

Whether these prices are realistic and fair becomes questionable when it can

shown that prices have been raised for other reasons. A leprosy drug, Thalomid,

fo

manufacturer, Celgene Corp, raised its price from US $4,000 to more than $35,000

per year, with an average five-month treatment plan. The company spokesman,

Brian Gill, stated that Celgene had “increased the drug’s price to reflect its

therapeutic value.”12

Until recently, the standard treatme

combined with a vitamin, Leucovorin, costing around $500 for a course of treatment.

With the newer drugs, the standard treatment for colorectal cancer—including

Eloxatin, Erbitux and A

Despite the high costs, these treatments do not guarantee a cure. Patients on the

5-FU treatment had on average a life expectancy of around 11 months; the new

treatments give patients a life expectancy of around 19 to 22 months.

A

months—with no assurance that quality of life is improved—for a 500% increase in

cost is not impressive.13 Devastated families may be left to cover these costs

following the death of a loved one.

Loss of Patent: Generic Drugs

T

a company. Loss of patents over the next few years could cost Pfizer up to US $14

billion in annual sales. The only way forward for

lo

It was noted in 2001 that the patents of several large brand-name drugs would

terminate by 2006. Over this five-year period, these drugs would have combined


USA sales approaching $20 billion. The loss of the patent meant that other

companies could manufacture generic forms of the drugs at a fraction of the price.14

Extending the Life of a Patent

145

USA federal authorities have led numerous investigations into whether anti-

stifle the launch of generic drugs.

vestigation was related to a deal between Bristol-Myers Squibb Co. and American

rtrooms

In ersion of the cancer

have saved cancer patients in the USA

0 million annually. Bristol-Myers Squibb, who held the original

t that

the generic

o be produced and marketed.

ls. However, the truth was that Taxol

had been discovered by the National Cancer Institute (NCI), which is funded by

competitive practices have been carried out to

In 2000, seven drug companies were accused of arranging deals, by which they paid

their generic competitors to keep their cheaper drugs off the market.15 16 One such

in

Bioscience Inc. regarding Taxol (Paclitaxel), a cancer drug.

Drug Patents and Generic Drugs

Many battles between companies holding patents on drugs and companies producing

generic (and cheaper) copies of such drugs are being waged currently in cou

worldwide.

2000, Ivax Corporation sought to market a cheaper, generic v

drug Taxol—called Paxlitaxel—that would

more than US $50

patent, challenged Ivax’s right to produce the generic drug.

Bristol-Myers Squibb eventually lost the court case, but the legal process mean

Ivax took 30 months to obtain the legal right to manufacture Paxilitaxel. Bristol-

Myers Squibb earned around US $3 million a day from Taxol sales, so it gained 30

months more sales time—and several billion dollars in sales—before

version was able t

With the generic version available, the cost of the drug fell by approximately one-

third in the first six months and by half after that.

Bristol-Myers Squibb claimed that around US $1 billion had been spent in R & D on

Taxol, including funding for 600 clinical tria


146

t of

ase, as

Patent for Testing on Children

ted on

ch

of o the

co ct was renewed, Rep. Henry Waxman (Democrat,

alifornia) stated:

The worth of a patent depends on the value (and marketability) of the drug involved.

the patent on a pain-killing drug for

tent

enix

harmaceuticals) and $295 million (Eli Lilly and Galen Holdings).19

nt is relatively common,

lbeit expensive. These lawsuits are not restricted to company versus company but

s of research.

taxpayers. Kurt Blum, an NCI scientist, discovered the anti-cancer properties of the

Pacific Yew tree bark in 1963. Bristol-Myers Squibb took over the developmen

Taxol in 1989, receiving FDA approval for its use in December 1992. In this c

in most others, no profit was returned to the taxpayers.17

Extending a

Another way in which companies can extend the life of a patent is to investigate the

potential use of their drugs in the paediatric market. As very few drugs are tes

children, their use in childhood remains scientifically largely unknown.

The USA ‘Best Pharmaceuticals for Children Act’ gives brand-name pharmaceutical

manufacturers an extra six months of exclusivity if they test their products on

ildren. This act, originally passed in 1997, was renewed in 2001 to the discomfort

many legislators: the longer the patent times, the higher the cost of the drugs t

mmunity. When the A

C

If we look at just 25 more drugs that are coming up for exclusivity soon, this law will add

at least $11 billion to $12 billion to the nation’s healthcare bill.18

Patent Buyouts

The US $1.3 million paid by Eisai to Elan, for

cancer patients, is on the lower end of the scale of payments. A patent buyout

between Immunex and Schering AG was settled at US $380 million in 2002. Pa

licensing agreements in 2003 were settled at US $330 million (Novartis and Id

P

Patent Lawsuits

Lawsuits abound in the field of patents, with many speciality law firms devoted

purely to the practice of patent law. Suing for breach of pate

a

have, on several occasions, involved universities as source


147

ed Glaxo Wellcome PLC over the issue of

viral compounds

lowship

ndowment with the royalties generated by sales of Ziagen.

patent will fall upon RCT. A

tatement on the web site for the university outlining these cases ends with:20

e

volved, human nature seems to dictate arguments

the

es.

ting the patent-holding company’s legal interests.

In 1999, the University of Minnesota su

royalties from the drug Ziagen, an AIDS drug containing anti

discovered by researchers at the university. The University received a patent

settlement payment of US $300 million, and established a Graduate Fel

E

The lawsuit involving the Michigan State University and their technology-licensing

company, Research Corporation Technology (RCT), is discussed in detail on

page 207 in Chapter 7, Academic Freedom—Academic Funding. Following the

lawsuit, four generic drug companies are contesting the patent held by Michigan

State University. The responsibility of protecting this

s

In short, Cisplatin has produced not only physical, but also monetary, side effects. In th

past few years, there have been two lawsuits contesting how the profits of Cisplatin

should be distributed.

When large sums of money are in

over the distribution of funds. The amounts involved in such legal action appear

enormous, but in the context of potential earnings from a ‘blockbuster’ drug,

investment may be a justifiable and reasonable outlay for the compani

Abbreviated New Drug Application (ANDA)

The Hatch-Waxman Act, passed by the US Congress (Drug Price Competition and

Patent Term Restoration Act) in 1984, was meant to streamline the approval of

generic drugs, while protec

The Hatch-Waxman Act introduced the Abbreviated New Drug Application

(ANDA), whereby a generic manufacturer could bypass the long and involved

process of safety and efficacy testing if they could show that their generic drug was

the same as, and bioequivalent to, an already patented drug.

To apply for ANDA, the applicant must show that either:

Ü No patent information has been submitted to the FDA on the drug product that

is the subject of the ANDA;


148

on a particular date; or

Ü An existing patent is invalid or will not be infringed by the manufacture, use

ould then give notice to the patent holder of their

application. If the holder of the patent wished to challenge the ANDA, they would

ys. If

arly consumers. This initiative

cting Patents

rotecting a patent against generic alternatives has in some cases proved to be a

emarked Hytrin for BPH), used in treatment of Benign Prostatic Hyperplasia.

eneva filed an ANDA for both capsulated and tablet versions of Hytrin. Abbott

a ould not market

Terazosin HCL until the patent infringement litigation for the tablet Terazosin HCL

was resolved, or until the entry of another generic Terazosin HCL product. Abbot

agreed to pay Geneva $4.5 million per month until the final resolution of litigation.

Ü An existing patent has expired;

Ü An existing patent will expire

or sale of the drug product for which the ANDA is submitted.21

Companies filing for ANDA w

need to initiate a patent infringement notice against the applicant within 45 da

no infringement notice was filed, the FDA approval would proceed according to the

FDA’s expedited schedule. If a patent infringement suit was filed, FDA approval

would be held until the date of the patent expiration.

The Act was intended to benefit all parties, particul

followed a 1998 Congressional Budget Office study that found generic drugs saved

US consumers $8 to $10 billion in retail pharmacy sales in 1994.

The Cost of Prote

P

costly business. In mid–1999, the US Federal Trade Commission settled an

anticompetitive agreement between Abbott Laboratories and Geneva

Pharmaceuticals, Inc., an indirect wholly-owned subsidiary of Novartis Corp.

Geneva had filed an ANDA for the production of a generic version of Terazosin HCl

(trad

G

sued Geneva for patent infringement for the tablet version of Terazosin HCL but,

through error, did not file against the capsule version. When Geneva was granted

FDA approval to market the generic capsule version, they informed Abbott of their

intention to market the drug unless Abbott paid them not to.

Abbott and Geneva then entered an agreement whereby Genev w


149

neric version would cost Abbott over $186

at a

rge percentage of revenue would be directed to R & D, and that innovation would

is

armaceutical analysts at the investment bank Dresdner

ut

rugs had

in

umbers of competing discovery

groups has decreased. It has become easier to use combinatorial chemistry to find

or existing drugs, rather than look for chemical

been

Abbott had estimated that sales of a ge

million in sales in just six months.22

When profit margins for one drug are so high, the lengths to which companies may

go to protect patent rights becomes easier to understand.

Research & Development

Research and Development (R & D) has to be the life-blood of any company

involved in the competitive business of selling drugs. It might be expected th

la

either increase or be maintained at the current level. Over the last few years, th

does not appear to be the case.

Decrease in New Drug Development by Pharma

In 2000, according to ph

Kleinwort Wasserstein, costs for launching a new molecular entity (drug) were abo

US $800 million.

By 2003 this cost had risen to US $1.4 billion and the numbers of new d

fallen ten-fold. This shortfall in output was attributed to a loss of efficiency of

research in the pharmaceutical company laboratories. The fastest growth area

pharmaceuticals became the manufacture of generic drugs.23

Why has research into new molecular entities diminished?

With the new mergers between drug companies, the n

minor variations or modifications f

diversity in natural products. More than half the drugs currently approved have

either natural products or related to them. Eliminating natural products as a source of

new drugs lessens true novelty in the search for new products.24


150

ustry.

T eatment at the National Cancer Institute (NCI) contains a

ection—the Developmental Therapeutics Program (DTP)—that is funded by both

Re

The Laboratory of Drug Discovery R ent assists in the

ent of agents with high priority for the treatment of cancer or HIV.

ent of many cancer therapeutic drugs, such as the following

its

inical studies and a

major role in clinical trials—marketed by Bristol-Myers Squibb

ent

t e National Institutes of Health (NIH)—marketed by Bristol-

Myers Squibb without return to tax payers.27

unding, Corporate Gain

c science, that is,

R & D in Government Laboratories

Not all the cost of research and development is borne by the pharmaceutical ind

The Division of Cancer r

s

government and industry. The DTP includes the Laboratory of Drug Discovery

search and Development and the Drug Synthesis and Chemistry Branch.

esearch and Developm

developm

The Drug Synthesis and Chemistry Branch acquires, screens and evaluates the

therapeutic potential of new compounds.25 This NCI department has assisted in the

successful developm

small sample:26

Ü Hydroxyurea: the NCI discovered this drug and provided major input in

clinical trials—marketed by Bristol-Myers Squibb.

Ü Carboplatin: the NCI played a significant role in the pre-cl

Ü L-Asparaginase: discovered at Cornell University, with significant pre-

clinical and clinical trial assistance by the NCI—marketed by Merck.

Ü Streptozotocin: discovered at the NCI with major clinical trial assistance—

marketed by Upjohn.

Ü Taxol: considered one of the block-buster drugs, Taxol had its developm

funded by h

Public F

In 1997, the Cambridge Healthtech Institute (CHI) followed more than 45 000

references from US patents to the scientific research papers quoted. It was found that

70% of the citations used in US industry patents came from publi

science carried out in universities, government laboratories or other public

agencies.28


151

discovery,

evelopment or testing.29

ealth (NIH) provided $17.8 billion for research, and

the major proportion was expended for basic research; the top 10 pharmaceutical

by the pharmaceutical companies.

owever, the basic research into new molecular entities is funded mainly by

)

agreed generally as being the cost of R & D in pharmaceuticals?

7.

d risen by 12% because of larger numbers

nrolled in trials.31

ral

ounts:

ere

l calculation of the value of the

R & D investment if invested elsewhere;

It appears that most of the drugs passing through the FDA have received money

either from the National Institutes of Health or the FDA to assist in

d

Quoting DeAngelis, in the Journal of the American Medical Association (JAMA):

In 1999, the National Institutes of H

companies spent $22.7 billion, primarily on clinical research. 30

It appears that the commercialisation of drugs—the clinical trials needed to show

improvement over previous drugs—is handled

H

government.

How Much Does Pharma Spend on R & D?

How much pharmaceutical profit is spent on research and development of new

drugs? Are the figures given by Dresdner Kleinwort Wasserstein (see page 149

A study carried out at the Tufts Center for the Study of Drug Development in 2001

stated that the average cost of discovering and developing a new drug had risen to

US $802 million, from the $231 million the same Tufts group had estimated in 198

The leading author of the study, Joseph DiMasi, stated that the largest increase in

cost was for clinical trials, which ha

e

The consumer watch-dog group Public Citizen has queried this study on seve

c

Ü The drugs listed by DiMasi did not receive any government support at any

stage of their discovery and development. This is contrary to the norm, wh

many, if not most, new drugs do have government input;

Ü The estimate of $802 million cost included figures for ‘opportunity cost of

capital’ of $399 million, which is a theoretica


152

e a deduction of 34% of R & D expenses, making the

stify increased pricing of drugs.

venue

ceutical industry projects.

According to Public Citizen, only 12% of revenue went into R & D, whereas 30%

970

$194 million (in 1990 dollars).34

his is markedly less than quoted by DiMasi ($231 million) in his 1987 study.

in the USA was approximately $65 million (in 1990 dollars),

ith each drug taking around 12 years to bring to fruition. This brought the total

ic

were judged as offering no new therapeutic benefit.

Ü Federal Tax laws provid

after-tax outlay around $240 million per drug at that time.32

According to Public Citizen, the Tufts Center for the Study of Drug Development is

funded to a large degree by the pharmaceutical industry, and these figures are used to

ju

The production of new drugs is a hugely expensive affair, yet the amount of re

allocated to R & D may not be as high as the pharma

was spent on marketing and administration33.

The US Office of Technology Assessment (OTA) produced a paper in June 1994,

assessing multiple studies on the costing of pharmaceutical R & D. Between 1

and 1982, the after-tax cost per drug—that successfully achieved FDA approval for

the market—lay somewhere between US $140 and

T

Profits from New Drug Exploration

How financially rewarding is new drug exploration? The after-tax R & D outlay for

new drugs in the 1980s

w

after-tax cost to approximately $194 million, but the return was at least $36 million

more than the R & D investment.35

With the enormous amounts of money—government and industry sourced—spent on

R & D for new drugs, what has been the effect for the end-user, the patient?

The OTA study found that most new drugs being marketed offered little therapeut

advantage over the older drugs already in supply.36 A 1990 European study was

quoted as finding that, between 1975 and 1989, only 30% of new drugs “added

something to therapy”, meaning that over half of all drugs introduced into the USA


153

ion between government, representing the people,

nd industry, representing its own select group of people in a money-making

om harm,

n etween government and the pharmaceutical industry has become

lurred, even in sections of the government charged with the responsibility of

ministration (FDA)

gency

ct was small.

st lots

secret’. The AMA had laboratory tests carried out and

ined that the problem was diethylene glycol.

aged

e drug, 107 people had died. Another death occurred with

f the Massengill chemist who had added the diethylene glycol to the

Pharma and Governments

There has always been a distinct

a

enterprise. Government has a responsibility to its people to protect them fr

whereas industry has responsibility only to its shareholders.

The separatio b

b

regulating the industry and of protecting the public.

Growth of the US Food and Drug Ad

In the USA, the Food and Drug Administration (FDA) oversees the production and

public use of products manufactured by the pharmaceutical industry. The Food and

Drug Act was passed in 1906 to force manufacturers to list ingredients on the

packaging of medicines and to maintain purity of foods. For many years, the a

involved in the enforcement of this A

In 1938, a liquid form of sulphanilamide was found to contain a lethal solvent,

diethylene glycol, which had been added to sweeten the formula. The manufacturers

of the drug, the Massengill Company of Bristol, Tennessee, shipped out the fir

on 4 September, 1937.

In October, Dr James Stephenson asked the American Medical Association (AMA)

for details of the composition of the drug, as six of his patients had died immediately

after taking it. Massengill provided the AMA with the list of ingredients, on the

proviso that they were kept ‘

determ

At the time, the FDA could not legally investigate or prosecute unless it could be

shown that the labelling on the bottles was incorrect. By the time the FDA man

to recall all bottles of th

the suicide o


154

his event resulted in passing the Food, Drug and Cosmetic Act, whereby

dget, but

to 79%. The corresponding increase in the numbers of staff

volved with new drug approval meant that funding was diverted from FDA

he

onetary input by the pharmaceutical industry has also extended to FDA new drug

h

able the most funding to be channelled into

ew drug classification—eliminating half of the FDA in-house scientists and

formulation of the drug. The company was eventually fined $26 000, the largest fine

levied by the FDA to that date.

T

manufacturers had to list all ingredients on their labels and submit a New Drug

Application (NDA) to the FDA, demonstrating that the new product was safe for its

intended use.37

This new law resulted in major increases in the size and duties of the FDA.

FDA Funding for New Drug Approvals

The approval of new drugs has become the largest and most highly funded section of

the FDA. The budget for new drug review in 1992 was 53% of the total bu

by 2003 it had increased

in

laboratories and drug safety experts.

Reduced Funding for Monitoring Drug Safety

The concentration of resources into the drug approval section has meant that the

FDA is less able to efficiently monitor the ill-effects of drugs that are already on t

market. This has meant a reliance on voluntary reporting of problems by the

companies manufacturing the drugs.

M

reviewers. Their budgets gave them the perks of travelling to conferences and

attending courses that were denied to those officers in the drug safety section, whic

is not funded by industry.38

Stripping whole sections of the FDA to en

n

lessening their access to laboratory equipment—does not bode well for patient

safety.


155

d

01 editorial in The Lancet, during a six-year period in the 1990s the FDA

hired close to 700 medical officers for new product review.

stry funding. These new officers—funded by industry—would review new

rugs from their original source of wages. A survey of the FDA medical officers

This problem was revealed on a large scale with the Vioxx scandal. Investigators

in England found that 28 pages of data relating to

ose on

sent

wn

ng the increase in heart risk with the use of Vioxx. Merck had

eveloped a training manual to help company staff fend off questions about safety

This search for more money and staff did not only occur internally. As was pointe

out in a 20

This hiring was made possible through a stipulation in the 1992 Prescription Drug

User Fee Act that allowed US $300 million (required for the hiring) to be sourced

from indu

d

blamed this ‘arrangement’ as a reason for the decline in standards in drug approval.39

FDA Suppression of Commercially-Sensitive Data: the Vioxx Scandal

The FDA has also caused concern with incidents where they appear to have actively

suppressed access to data on prescription drugs, apparently because of its

commercial sensitivity.

from The Independent newspaper

Vioxx—a non-steroidal anti-inflammatory drug (NSAID)—had been removed from

FDA files because of confidentiality. The newspaper also stated that Dr Peter Juni,

who had raised issues concerning the safety of Cox-2 inhibitors, claimed that his

efforts were being obstructed by the FDA, and he was told that data on trials of

Celcoxib (NSAID) and Valdecoxib (NSAID) had been deleted because they

contained trade secrets.

A report by Dr David Graham, Associate Director of the FDA Office of Drug Safety,

stated that patients on Vioxx suffered five times as many heart attacks as th

Naproxen (NSAID). Dr Graham’s supervisors refused permission for him to pre

his findings at a meeting in France. They later attempted to interfere with the

publication of his study in The Lancet.40

The story of the eventual Vioxx recall made headlines world-wide. It became kno

that Merck had used a consistent pattern of intimidation to silence scientists who

were questioni

d


issues. The scandal destroyed Merck’s credibility and led to class actions against

Merck.41

FDA: Servant of Industry?

156

he cosy arrangement between Pharma and government is viewed with scepticism

FDA

n writing on “Lotronex and the FDA: a fatal erosion of

tegrity” discussed the ethical issues raised by the Center for Drug Evaluation and

overseer and

ind re

tha

the lar, as becoming the

ervant of industry.

diminished by adverse publicity and fines. There may be a

drop in share prices, as there was for Merck following the Vioxx scandal, but without

drugs from ethical companies are not

r,

ritish Pharmaceutical Industry—‘Voluntary’ Code of Conduct

alth

ng

T

by many people, with justifiable concern as to the transparency of decisions by

officials.

The editor of The Lancet, whe

in

Research (CDER), a section of the FDA.42 The financial ties between

ustry brings “an impossible conflict for safety issues to be overseen by a cent

t receives funding from industry to review and approve new drugs.” Dr. Horton

n goes on to refer to the FDA, and the CDER in particu

s

Lack of Constraints on Pharma

Perhaps surprisingly, the value of reputation for the pharmaceutical companies does

not appear to be hugely

any lasting effect. Patients who wish to buy

given a choice. The prescription is written by a third party, the prescribing docto

who is unlikely to choose a drug based on company ethics.

B

The UK situation is broadly similar to that in the USA. In April 2005, the

Association of the British Pharmaceutical Industry published a tougher code of

conduct, following criticism that self-regulation had failed to stop misleading claims

being issued about products. The criticism came in the form of a report from a he

select committee, which cited “examples of breaches of advertising regulations;

cover-ups of negative medical information; and giving misleading information to

prescribers.” MPs also criticised the long delays by the industry in investigati

complaints.43


157

lties

only be given

conomy airline tickets and should not be lodged in ‘lavish’ accommodation.

ges; all

promotional material should include information regarding adverse drug reactions;

to physicians in the first

ociation of the British Pharmaceutical

.

aming and shaming’ seems to have provided little incentive for companies to

anies

r, and the film released in 2005,

et a pharmaceutical company as the evil protagonist of the story. The concept of the

ind already has a distrust of the morals of these monolithic companies. The Vioxx

a

This new code of conduct however is a voluntary code: there are no legal pena

for breach of the code. The major changes to the previous code relate to tighter rules

governing hospitality, in that delegates sponsored by companies may

e

The medical advertising for a drug may now be no longer than two pa

and companies should make no more than three mail-outs

six months of a drug launch.

According to Andrew Hotchkiss, the managing director of Lilly UK:

The key thing for us is the reputation of the industry. ‘Naming and shaming’ is the

biggest sanction. At the end of the day any company can pay a fine – whether it be £100

or £10 000 but more valuable is the company’s reputation.

The harshest penalty available to the Ass

Industry for breaking the codes of conduct of the Association would be expulsion

This has never happened. In fact the board has never required a company to publish

a corrective statement.

Ineffectiveness of ‘Naming and Shaming’

‘N

restrain from hard-sell techniques. The reputations of the pharmaceutical comp

do not seem to be held in much esteem world-wide.

John Le Carre’s 2001 novel The Constant Gardene

s

great Pharma giants ruthlessly using and eliminating people reached the public stage

without there seemingly being any disbelief from the public. Perhaps the public

m

scandal confirmed, for many, the lengths to which companies would go to make

profit, but ‘naming and shaming’ of Merck has not resulted in any permanent

economic repercussions for the company.


158

he section titled Litigation (see page 179) shows increasing and unashamed

n

orate decisions.

ften drawn from the industry they

Australia, we have benefited from a unique system of government payment for the

ided

al

PBS),

eference Pricing to Keep Prices Low

in the

rigorous cost-effective analysis, prior to being listed on Medical Benefits.

price of a new drug must be

rug

ter (in profit

rms) may achieve minimal sales on the Australian market unless listed by the PBS.

panies intent is to gain the highest

rice possible, whereas the PBAC tries to obtain the best price for the public.

T

corporate malfeasance, indicating that ‘naming and shaming’ is of no consequence i

any endeavour to induce social responsibility in corp

As staff members of the regulating agencies are o

police, they view their role as one of partners rather than overseers.44

Australian Pharmaceutical Benefits Scheme (PBS)

In

drugs we require. When Howard Florey’s role in discovering penicillin became

known, in a flush of national pride the Labor government of the time (1948) dec

that all Australians should benefit from this drug, regardless of their financi

situation. The government introduced our Pharmaceutical Benefits Scheme (

which ensured that government paid the cost of needed drugs.

R

We are one of the few countries to have such a scheme, one that is dramatically

different to the medical system of the USA. The PBS scheme was revamped

early 1990s, when Professor David Henry became the driving force in the Scheme to

contain the rising prices of drugs. He introduced a system whereby each drug would

undergo a

This system of ‘reference pricing’ means that the

compared with the price of drugs of the same class. If a new drug cannot be shown

to offer more in performance than the cheapest available product, then the new d

receives the same price as the cheapest product.45

Because of reference pricing, a drug with the potential to be a block-bus

te

This has caused many conflicts between the Pharmaceutical Benefits Advisory

Committee (PBAC) of the PBS, and the pharmaceutical companies attempting to

have new drugs listed. The pharmaceutical com

p


159

An gs

tha prior to major changes to the PBAC.46

Po PBS

Pr

Pf very unhappy about the way their

pro

ctor of Pfizer in Australia, Dudley Schleier, developed

l

etails of the meetings of this group were not available to the Pharmaceutical

an

inisters were experiencing

t pressure from the pharmaceutical industry. They later learned that the

ns in the Australian Pharmaceutical Manufacturers Association

d ‘Alan’s Antidotes’.

ABC Four Corners story, Paying the Price, examined the politics and dealin

t occurred

litics and Industry Put Pressure on the

ofessor Henry was visited in 1997 by the new Australian Medical Director of

izer US, who made it clear that Pfizer were

ducts were being dealt with by the PBS of Australia.

The new Managing Dire

strong connections with the current Liberal government and became one of the

founding members of a Commonwealth Government industry work group,

established in June 1998. This group was made up of the CEOs of six drug

companies and two Cabinet ministers—the Minister for Health, Dr Michae

Wooldridge, and the Minister for Industry, Senator Nick Minchin.

D

Benefits Advisory Committee (PBAC) of the PBS. However, Four Corners

accessed ministerial briefing notes showing that most of the discussion had centred

on the PBS and the pharmaceutical companies’ dissatisfaction with their Australi

income.

Government Staff Become Industry Lobbyists

A year later, Professor Birkett (Chairman of the PBAC) and Professor Henry met

with the two ministers, and were informed that the m

significan

ministers’ principal adviser had resigned and joined a pharmaceutical company that

subsequently became involved in legal proceedings against the PBAC.

By early 2000, the first assistant secretary at the Department of Industry, Alan Evans,

had been recruited as a lobbyist for the pharmaceutical companies. Mr Evans began

a series of colum

(APMA) newsletter, title


160

erra for quite some time, I can

recognise policy paralysis when I see it ...

da and

ment set up the Tambling

eview was never

ced on the length of time

at members of the committee could serve, eight years for committee members and

n

on would be pushed

rough the Senate, and that all members who had been on the committee for more

Four weeks prior to th

of the pharmaceutical co

background paper (sourced by ) listed the membership of the PBAC as

n issue and stated that “Industry is greatly concerned about membership of the

A selection from Alan’s Antidotes states:

The pressure to suppress prices is overriding all other factors. It can be and will be

redressed.

…having been at the centre of policy making in Canb

... But in some ways this might not be a bad thing as it will allow us to set the agen

develop policy options which best suit us …

... We might have to break a few eggs to make the omelette, but it will be worth it in the

end.47

The Tambling Review

The industry continued to press for change and the Govern

Review, with an industry wish list on the agenda. Even though this r

made public, Four Corners obtained a copy, revealing that the industry had directly

lobbied government to have one of their representatives positioned on the

Pharmaceutical Benefits Advisory Committee. The Tambling Review concluded,

however, that this “could result in an untenable conflict of interest.”

The Tambling Review recommended that a time limit be pla

th

twelve years for the chairman. Professor Henry had already spent ten years as a

committee member, with two years left of his contract. At their regular meeting i

December 2000, the committee was notified that legislati

th

than eight years would have to leave the committee.

is, the Prime Minister, John Howard, had met with the CEOs

mpanies located in his electorate. A copy of the confidential

Four Corners

a

PBAC, particularly the public hostile attitude of some members and staff to

industry.”


161

o had

s

Clear was, at the time, a director of a

biotech company working in product development.

r

sly judged to

0 million blow-out in the PBS budget,

and Pharmacia. (The scandal over Vioxx

S

Australian–USA bilateral Free T ent. Australians have been repeatedly

assured by our government that this Free Trade Agreement would not change the

PBS. However as be on into the Free Trade Agreement that may

lead to unwante cussio ustrali

Annex 2-C of t Trade relates

titled ‘Transpar nd sub commits Australia to “make available an

independent review process” of decisions by the PBAC.

According to Prof the Australian National University Law

faculty:

If the Australian Government resisted, then there would be the threat of litigation, and if

the threat of l was n e US w ely bring an action because it

would be pre o ry, whi presum bly disappointed by

the outcome of the independ

How this agree ight ch aceutical pricing is as yet unknown.

Australia has o share rld-wid ket. Professor David

Henry has stated that the concern for US drug m rs is that the Australian

system is being copied by other countries, often with referral from orld Health

When the new committee convened, its twelfth member was Mr Pat Clear, wh

been a senior executive with Bayer and Glaxo Wellcome for 20 years, with five year

as the CEO of the industry’s lobby group. Mr

One of the very unsettling outcomes of this story was that the pharmaceutical

industry succeeded in gaining higher prices than had been previously allowed fo

Celebrex and Vioxx, two drugs that the expert committee had previou

be not cost-effective. This resulted in a $15

which boosted the profits of Pfizer, Merck

involving Merck and the FDA is discussed on page 155.)

Repercussions of the Free Trade Agreement on Australia’s PB

On 18 May 2004, Mr Mark Vaile, Minister for Trade (Australia), signed the

rade Agreem

, there h en an inserti

d reper ns for the A an people.48

he Free Agreement to pharmaceuticals. Clause 2 is

ency’ a clause (f)

essor Peter Drahos of

itigation ot enough, th ould ultimat

ssured to do s by US indust ch would be a

ent review.

ment m ange pharm

nly a 1% of the wo e drug mar

anufacture

the W


162

isation. The outcome for Australian pricing of drugs may have serious

ustry.

Donations to Australian Political Parties

given to the two leading Australian political

Organ

repercussions for Australians, but equally importantly it may also have world-wide

significance for the pharmaceutical ind

What Price Political Influence?

Lobbying of political parties occurs in most democratic countries. Most industry

groups participate in some form of lobbying. The more money involved in the

industry, the more there is to give to political parties to curry favour.

The following table shows donations

parties for the years 1998 to 2005, at both federal and state levels (for NSW). These

donations are listed under the Pharma/Health Industry category.

Table 6-3: Donations to Australian Politi cal Parties by the Pharma/Health Industry

YEAR PARTY AMOUNT

ELECTION YEAR

1998/99 Labor Federal $55 000.00 *

1999/00 Labor Federal $20 000.00

200 00/01 Labor Federal $53 2 0.00 *

2001/02 Labor Federal $82 500.00

2002 ederal $7 50/03 Labor F 0.00

2003 a 89 5/04 L bor Federal $ 00.00

2004 a 25 0/05 L bor Federal $ 00.00 *

1998 L/99 abor NSW $10 000.00 *

1999 L/00 abor NSW $2 000.00

2000 L/01 abor NSW $2 200.00

2001 L/02 abor NSW $13 100.00

2002 L/03 abor NSW $55 176.00 *

2003 L/04 abor NSW $65 400.00

2004 L 44 6/05 abor NSW $1 00.00

1998 b/99 Li eral Federal $118 210.00 *

1999/00 Liberal Federal $44 100.00

2000/01 Liberal Federal $127 600.00 *




2004/05 Liberal Federal $216 600.00 *

1998/99 Liberal NSW $135 930.00 *

1999/00 Liberal NSW $23 500.00

2000/01 Liberal NSW $24 800.00

2001/02 Liberal NSW $115 047.00

2002/03 Liberal NSW $125 200.00 *

2003/04 Liberal NSW $266 600.00

2004/05 Liberal NSW $196 900.00


163

Notes

Ü The figures above are taken from www.democracy4sale.org; accessed on 8 September 2004.

a

r arch

bu e t e a

l p d P

t n a d r w

e o t

onations to USA Political Parties

The t

philoso ustralian Liberal

Par is

sim r

www.o ts.org/industries, with thanks to the Center for Responsive Politics.

s

% to Repubs

:

Ü Federal electio

were held in Ap

ns were held in

il 1999 and M

October 1998, N

2003.

ovember 2001 nd October 2004. NSW State elections

Contributions to the Liberal Party have been approximately double that of

contri tions to th Labor Par y, at both f deral and state levels. Given th t the

Libera Party held ower in fe eral politics, whereas the Labor arty was in power in

NSW, he disparity in donatio s clearly h d more to o with pa ty policies than ith

who h ld the seat f power at he time.

D

si uation in the USA is similar, where the two major parties have broadly similar

phical beliefs to the two main Australian parties. The A

ty similar to the USA Republican Party and the Australian Labor Party is

ila to the USA Democrats. The following are figures taken from

pensecre

Table 6-4: Pharmaceuticals/Health Products — Long-Term Contribution Trends

Election Cycle

Total Contributions

Contributions from

Individuals

Contributions from PACs

Soft Money Contributions

Donations to

Democrats

Donations to

Republicans

% toDem

2006* $10 432 530 $3 889 743 $6 542 787 N/A $3 235 336 $7 199 024 31% 69%

2004* $17 897 820 $8 510 111 $9 387 709 N/A $6 021 651 $11 851 794 34% 66%

2002 $29 445 451 $3 335 540 $6 957 382 $19 152 529 $7 686 772 $21 733 672 26% 74%

2000 $26 688 292 $5 660 457 $5 649 913 $15 377 922 $8 225 197 $18 402 165 31% 69%

1998 $13 169 694 $2 673 845 $4 107 068 $6 388 781 $4 722 879 $8 408 570 36% 64%

1996 $13 771 496 $3 430 216 $3 584 217 $6 757 063 $4 693 810 $9 054 632 34% 66%

1994 $7 712 082 $1 940 929 $3 477 146 $2 294 007 $3 388 028 $4 339 984 44% 56%

1992 $7 924 762 $2 389 870 $3 205 014 $2 329 878 $3 442 821 $4 509 323 43% 57%

1990 $3 235 192 $771 621 $2 463 571 N/A $1 497 179 $1 750 973 46% 54%

Total $130 277 319 $32 602 332 $45 374 807 $52 300 180 $42 913 673 $87 250 137 33% 67%


164

Cycle Contributions from Individuals

butions from PACs

Soft Money Contributions

Donations to

Democrats

Donations to Republicans

% to Dems

% to Repubs

Table 6-5: Pharmaceutical Manufacturi ng — Long-Term Contribution Trends

Election Total Contributions Contri

2006* $5 711 219 $1 577 220 $4 133 999 N/A $1 573 720 $4 139 329 28% 72%

2004* $9 887 445 $3 612 266 $6 275 179 N/A $2 913 675 $6 954 645 29% 70%

2002 $21 763 755 $1 533 183 $5 436 068 $14 794 504 $4 328 753 $17 412 495 20% 80%

2000 $19 344 597 $3 231 334 $4 588 705 $11 524 558 $4 364 311 $14 941 356 23% 77%

1998 $9 028 646 $1 214 935 $3 181 744 $4 631 967 $2 807 263 $6 216 658 31% 69%

1996 $9 264 843 $1 393 124 $2 823 154 $5 048 565 $2 708 062 $6 544 977 29% 71%

1994 $5 379 522 $908 086 $2 768 621 $1 702 815 $2 133 172 $3 261 940 40% 61%

1992 $4 903 427 $1 185 783 $2 385 144 $1 332 500 $2 378 054 $2 547 705 48% 52%

1990 $2 341 170 $442 354 $1 898 816 N/A $1 027 861 $1 322 419 44% 56%

Total $87 624 624 $15 098 285 $33 491 430 $39 034 909 $24 234 871 $63 341 524 28% 72%

Notes:

Ü The numbers in Table 6-4 and Table 6-5 are based on contributions of $200 or more from Political Action

Committees (PACs) and individuals to federal candidates, and from PAC, soft money and individual

donors to political parties, as reported to the Federal Election Commission.

Ü Although election cycles are shown as 1996, 1998, 2000, and so on, they actually represent two-year

periods. For example, the 2002 election cycle ran from 1 January 2001 to 31 December 2002.

Ü Data for the current election cycle were releas

29, 2006.

ed by the Federal Election Commission on Monday, May

n their electoral campaigns. It was the Labor Party, not the Liberal Party in

.

e drug companies are afraid he’ll do—authorize the

secretary of Health and Human Services to negotiate prices—I think that would be a

obbying money is often well hidden, and so does not always appear in tables such

Again, a vast disparity exists between donations to the two parties, with almost

double the amount of funding being given to the Republican Party. Both the

Australian Liberal Party and the US Republican Party support business as a major

priority i

Australia, who introduced our PBS system

Prior to the Bush versus Kerry election, there was great unease as to possible

repercussions for pharmaceutical companies and their investors in the event of a

Democrat win. Richard Evans, the pharmaceuticals analyst at Bernstein & Co.,

stated in 2004:

If Kerry were to win, and do what th

fairly constant pressure on the industry, and would change the nature of that investment

forever.49

L

as those shown above. The American Association for Retired Persons (AARP)—a

non-profit organisation for people 50 years and over—reported in their AARP


165

ns

search

Pfizer

ion. These groups were known to

advocate for industry-friendly policies.

ws

hting

ian

per prescriptions

rugs than are available in the USA50.

ns

be some form of connection between medical

ractitioners and the suppliers of the medications they use in their practices. Doctors

Doctors, and the way they are trained, determine the types of treatment that are given

. It is doctors who enrol patients in clinical trials and who find

al process and

Bulletin (2003) that they had examined tax records for three non-profit organisatio

that represented older Americans.

They found that the United Seniors Association received more than one third of its

funding in 2001 from drug industry sources, including the Pharmaceutical Re

and Manufacturers of America (PhRMA)—the trade association for the industry—as

well as Citizens for Better Medicare (a PhRMA-funded non-profit group) and

Inc. The industry contribution was at least $3 mill

PhRMA has not restricted its lobbying to only the US government. CanWest Ne

Service reported, on 9 June 2003, that US $1 million had been contributed to fig

the Canadian drug regulatory system. PhRMA spent $450 000 to target the Canad

Internet pharmacy industry, which provides Americans with chea

d

PhRMA applied pressure through lobbying both the USA and Canadian governments

to prohibit Canadian doctors co-signing prescriptions for U.S. patients and to

introduce new requirements that patients must appear in person to have prescriptio

filled.51

Pharma and the Medical Profession

It would seem natural that there

p

make choices as to which drugs to prescribe in their treatments and, often, which

particular make of drug.

Importance of Doctors to Pharma

for varying conditions

new applications for drugs that result in the use of off-label marketing.

Medical doctors, therefore, are critically important to the pharmaceutical companies.

With influence from the industry exerted throughout the education


166

ater) in the clinics, there must be strong ethical checks and balances in place to

g or marketing tactic is to convince the recipients

(th

co

influenced financially by industry could be cynically likened to non-salaried

alesmen: providing a true bonus to any supplier.

Industry Support of Universities

s is not a new phenomenon. It certainly

t (2000)), it was estimated that ‘the great tax-

ee foundations’ had invested over a billion dollars in the nation’s medical schools.

ment, rather

an a no-strings-attached gift.

have

rmaceutical industry through lectures

and symposia funded by industry. This exposure does not cease once practice

MA Code of Ethics

(l

protect the concerns of the patient.

The primary goal of any advertisin

e doctors) to use the manufacturer’s products. How much influence can a

mpany exert on doctors before ethics and morals are breached? Doctors who are

s

Industry money flowing into universitie

occurred in the earlier part of the 20th century, but it increased greatly over the

second half of the century. Often funding comes from foundations, usually with

strong ties to industry, thus providing companies with tax relief.

By mid-1970 (Griffen quoted in Culber

fr

Half the schools received a part of their income from foundation ‘research’ grants,

whereas 16% of medical schools were funded entirely in this manner. The main

donors were the Ford Foundation, Kellogg Foundation, Sloan Foundation, Macy

Foundation, and the Commonwealth Fund, which has been described as a

Rockefeller ‘interlock’.52 This money was and is regarded as an invest

th

At the end of university life and the beginning of their medical careers, doctors

already had considerable exposure to the pha

begins. If anything, ties may become stronger.

A

The comfortable relationship that exists today between medical practitioners,

research scientists and the pharmaceutical industry has not always been in place.

The initial code of ethics of the American Medical Association (1847) regarded the

patenting and advertising of medicines to the public as unethical.


167

as

rapeutics, founded in

908. According to their bylaws:

, the connections between

industry and academic research are explored, as well as academia’s growing reliance

come, not only for trials but also for the running of departments.

at by prescription; to rely on the

fferings of the manufacturers for medicaments to treat their patients.

I have found relate to choices made by

developed that are easier to use and

ay be used alone or in combination with other chemotherapy products. This study

Early in the 20th century, the peak body representing scientists in pharmacology w

the American Society of Pharmacology and Experimental The

1

No one shall be admitted to membership who is in the permanent employ of any drug

firm… Entrance into the permanent employ of a drug firm shall constitute forfeiture of

membership.

This prohibition was not changed until 1941.53

Medical School Funding by Industry

In Chapter 7, Academic Freedom—Academic Funding

on industry for in

As governments decrease funding for universities and other centres of science, the

shortfall is being made up by industry.

Doctors graduate from teaching schools that meld medical teaching and industry.

From industry comes money to support schools and their expensive research trials.

From industry come the very tools of the modern medical practitioner: access to

pharmaceutical drugs. Doctors are taught to tre

o

How well can an ethical boundary be established between treating a patient by the

best and most inexpensive means and prescribing a treatment for self-benefit?

‘Financial’ Barriers to Oral Chemotherapy

Some of the most disturbing articles

oncologists in prescribing chemotherapy for their patients.

Bowers, Silberman and Mortenson (2002) conducted a study on the use of oral

oncology products by interviewing oncologists in 12 private-practice oncology

clinics.54 Oral forms of chemotherapy are being

m


168

ion

ading “Financial”: they found that interviewees considered loss of

income to be one of the major drawbacks for oral chemotherapy use.

from

n the

f

wer price than the insurance reimbursement.

eted the difference. This

profit margin was the major influence on the choice of drugs prescribed, rather than

to the patient’s particular need.

al representatives in exchange for prescribing a specific drug: the drug

at the representative is selling. The money invested by industry can bring strong

examined issues that could arise such as: patient compliance with taking medicat

on schedule; informing their oncologist as to side effects; payment by insurance

companies for oral chemotoxics; and ease of administration.

In a section of the paper headed “Barriers to Expanded Use”, the primary barrier was

listed under the he

Many oncology practices derive revenue from the treatment of patients with

injectable chemotherapy drugs, both from the administering of the drugs and

the sale of the drugs themselves. If the practice does not dispense the drugs, the

income from providing this service is lost.

Discount Drugs

Another recent study, conducted by the Universities of Michigan and Harvard and

reported in the New York Times, found that although payment variations for

treatment did not cause oncologists to favour chemotherapy over other treatments, i

chemotherapy was chosen as the intended treatment, then the reimbursement figures

did influence the type of chemotherapy given.55 Oncologists can profit from the sale

of these drugs through a chemotherapy concession, and can purchase the drugs at a

lo

The article quoted a government study as saying that discounts were as high as 86%

on some chemotoxics and that the doctors commonly pock

drugs being chosen for their appropriateness

Visits From Drug Representatives

Many studies have examined the ethics of doctors accepting gifts from

pharmaceutic

th

returns, but when the gift process is uncovered it can become a large and expensive

scandal, as elaborated below.


169

o

national

urvey of third-year medical students (from eight medical schools) in 2005 found

had

Managing Drug Company Gifts

doctors in the critical skills needed to

,

acy worldwide)

to the education given to medical and pharmacy students about drug promotion. It

any studies have shown an agreement amongst doctors that there are ethical issues

s

Payments to Doctors to Prescribe Drugs

ain turned whistle blower and

ted

actured

y Abbott.62

g

, 4400

Exposure to pharmaceutical promotion begins in medical school and appears t

continue throughout the working life of most medical practitioners. A USA

s

that 97% of students had eaten lunches provided by the drug companies, 94%

accepted small gifts (cups and pens) and 87% had attended drug company sponsored

Grand Rounds.56

Several papers highlight the need to educate

manage visits from drug representatives (if they are considered necessary)

encouraging them to forego the acceptance of gifts and samples and to refer to

scientific sources for the most reliable information on particular drugs.57 58 59

An international cross-sectional survey was conducted by the World Health

Organisation (with responses from 700 deans of medicine and pharm

in

was found that, throughout their university training, students usually had less than

one day devoted to learning about drug promotion. In almost one-third of cases, the

medical faculties devoted only one to two hours to this. The survey also showed that

medical schools generally gave less time to this topic than did pharmacy schools.60

M

with the acceptance of gifts from industry, but most feel that although ‘other’ doctor

may be swayed by this, they are not personally affected.61

When the former manager of Abbott Laboratories in Sp

instigated legal action against Abbott, it was revealed that Abbott annually budge

US $2.7 million for payments to doctors for prescribing specific drugs manuf

b

Four years later in Italy, there occurred one of the largest inquiries into the marketin

practices of the drug industry. Police listed almost 5000 people to be charged


170

to doctors.

mme involving oncologists,

ases, doctors were receiving a substantial

ro rata payment based on the numbers of patients treated with Hycamtin.63

re to free

ples of drugs. Compared to residents with no free samples, those with access to

their average wholesale price.

Out of the 106 statements examined:

Ü 12 were inaccurate but were favourable towards the drug in question.

of whom were medical doctors, including 1700 specialists. It was found that

GlaxoSmithKline had spent €228 million on such ‘sweeteners’

Of even more concern was evidence of a progra

pharmacists and sales representatives designed to promote Hycamtin, which is used

to treat lung and ovarian cancers. In some c

p

Drug Samples as a Marketing Technique

The giving of drug samples has long been a marketing technique by drug

manufacturers. In 2005, resident physicians at a primary care clinic, associated with

a teaching hospital in Minneapolis, were studied in relation to their exposu

sam

samples were more likely to write prescriptions for the heavily advertised drugs and

less likely than their peers to recommend over-the-counter drugs.64

Other studies have similarly found associations between prescribing habits and the

receipt of free samples. In 1998, it was estimated that 2.4 billion free samples were

distributed to USA medical centres. When a family medical centre was examined in

1992, it was found that over a four-week period there were 5 546 free samples in the

65practice, worth US $19 273, based on

Large sums of money are spent on marketing in this way to doctors. As figures on

this form of promotion have increased over the years, it seems safe to assume that

such marketing is profitable for the companies.

Effects of Drug Marketing on Level of Medical Care

What effect has this drug marketing had on the level of medical help given? Do

doctors easily identify the difference between scientific fact and sales hype?

In 1995, Ziegler et al conducted a study on the accuracy of drug information

provided by pharmaceutical representatives.


171

gnised

false statements by the representatives.

or most doctors, provision of information on drugs by drug representatives has

69 70 71

The most influential driving force affecting the prescribing habits of general

n expanding field. An Australian study from Newcastle on the

alue of industry-funded ‘educational’ meetings found that 62% of general

uch

Ü A large difference was noted between statements relating to competitor drugs:

none were favourable statements but all were accurate.

Ü Only seven of the 27 physicians (the recipients of the presentation) reco

Ü Ten of the physicians said that they were influenced in their prescribing of

drugs by the sales representatives.66

In a much earlier study (1982), Avorn et al found that, although physicians claimed

that scientific sources were more important in influencing their prescribing habits

than pharmaceutical sources, when questioned about two classes of drugs where the

scientific viewpoint was directly opposed to the commercial literature, the

understanding of most doctors reflected the commercial information.67

F

become an important source of education and influence, and this is often accorded

greater weight than the scientific evidence.68

practitioners has been shown to be the pharmaceutical representative, with hospital

consultants and observations of hospital prescribing taking second place.

It was found to be rare for doctors to initiate their own active information search. It

was, however, likely that they would be influenced by a patient request for a specific

drug.72 This fairly new concept of patients requesting brand-name drugs is discussed

in the issue of direct-to-patient advertising of drugs. See page 176.

Continuing Medical Education (CME) for Doctors

The use of industry-funded continuing medical education for doctors has increased

over the years and is a

v

practitioners, 71% of psychiatrists and 24% of physicians attended at least three s

industry-organised meetings every year.


172

ducation (CME) points, and .

provider.73 The HPMI,

ors includes Roche Products P/L., Altana

a, AstraZeneca, Bayer Australia Ltd., Boehringer Ingelheim P/L., Bristol-

Pfizer P/L., Sanofi Aventis, Schering-Plough P/L (Essex Pharma Division), Servier

points has been described as a ‘win–win’

Es, it offers the education

e on its own. It then recruits academic physicians to deliver the lectures.

supplies the necessary accreditation (also

for a share of the grant), and certifies it free of commercial bias.75 Such a situation is

onies spent on marketing and promotion by pharmaceutical

ompanies very difficult to ascertain.

This study showed that the topic and speaker were the most important reason for

attendance, rather than attaining Continuing Medical E

that industry CMEs play an increasingly important role in clinician education.

However, this study was conducted by the Hunter Postgraduate Medical Institute

(HPMI), an independent Newcastle and Hunter Valley CME

according to its web page, receives no money from government and is funded solely

by members and sponsors. The list of spons

Pharm

Myers Squibb Aust. P/L., Eli Lilly Australia P/L., Glaxo SmithKline, Janssen-Cilaq

P/L., Merck Sharp & Dohme (Aust.) P/L., Novartis Pharmaceuticals Aust P/L.,

Laboratories (Aust.) P/L., and Solvay Pharmaceuticals.74

How credible is such a study that shows the benefits of industry-funded meetings

likely to be when it is funded by industry?

Pharmaceutical Company Funding of CME

The use of independent providers for CME

situation in the USA. If the medical education and/or communications company

(MECC) is accredited by the Accreditation Council for CM

programm

Payment to the MECC comes in the form of ‘educational grants’ from

pharmaceutical companies, and the recruited academics are given a small share of the

‘grant’. If the MECC does not have the appropriate accreditation in its own right,

then it goes through a medical school that

clearly open to bias.

The listing of such monies spent in promotion as ‘educational grants’ makes the

deciphering of m

c


Bowman’s paper “The impact of drug company funding on the content of continuing

medical education”, quoted in Lexchin, found that:76

Ü Funded meetings were biased in favour of the sponsoring drug companies’

products.

173

’s drugs were mentioned more often and were more

E

ed independently of such support.

ng attendance of industry-

gs that

om 81

7. Prescription patterns were tracked for 22

acceptance of ‘all-

ed in the above studies have voiced concern in relation to

dustry funding. Whereas the majority of doctors do not expect their own clinical

rketing

harma and the Medical Journals

rs to

Ü The sponsoring company

likely to be attributed with positive clinical effects.

Ü When reference was made to competing drugs, these references were more

likely to be negative.

Katz et al (2002), noted that the range of topics offered by industry-funded CM

providers is narrower than when fund 77

Prescribing Habits Affected by Industry-Funded Meetings

When prescribing habits have been examined followi

funded CME meetings, a marked increase is evident in the prescribing of dru

were the subject of the symposium. One study showed a threefold increase fr

units +/- 44 prescriptions to 272 +/- 11

months prior to the symposium and for 17 months post symposium.78

This increase in prescriptions is also likely to be influenced by the

expenses-paid’ tickets to such symposia.79

Most doctors interview

in

judgement to be influenced in such a manner, the end result unfortunately is, that

when industry has a role in providing education to doctors, it does so as a ma

exercise and profits from this exercise.

P

When an industry-funded symposium is published in a peer-reviewed journal, the

benefit of the investment increases exponentially with the numbers of subscribe

those journals.


T

174

hese symposia have been found in many cases to focus on unapproved therapies of

itted

ves

in Journals

for advertising in those journals that permit this.

mination by three reviewers of 109 full-page advertisements in ten

ading medical journals found that:

advertisements as unbalanced.

ajor changes in another 34% before

publication.81

nti-hypertensive and lipid-lowering drugs

a particular drug, without having undergone the peer reviewed process that subm

papers to a refereed journal would.80 The appearance in a well-known journal gi

a veneer of scientific validity that is worth much to a company.

Drug Advertising

Pharmaceutical companies also pay

When the information given in the advertisements has been critically appraised by

external medical reviewers, doubts have been raised as to their accuracy.

A 1992 exa

le

Ü In 30% of the advertisements, two out of the three reviewers disagreed with

the advertising claim of the ‘drug of choice’.

Ü Reviewers agreed with a balance on efficacy versus side effects and

contraindications in 49% of the advertisements, but regarded 40% of

Ü In 44% of the advertisements, the information given would lead to incorrect

prescribing if physicians relied only on information in the advertisement.

Ü 57% of advertisements had little or no educational value.

Ü The reviewers would not recommend for publication 28% of the

advertisements and would require m

A 2001 study of four major refereed journals (containing 187 advertisements) found

that the advertisements generally did not provide adequate study design and

statistical information to allow an accurate assessment.82

An examination of advertisements for a

published in six Spanish medical journals found that, in almost 50% of the

advertisements, the promotional statement was not supported by the reference

provided, usually because the drug was being recommended for different patient

groups than the approved group.83


175

ers being the ‘hidden’ authors of articles

ical writers,

Writers Association found that 80% of 71

paper that was accredited to another

d evidence of ghost

ler

ated misapplication of authorship criteria and

appropriate assignment of authorship.” These findings were similar to previous

ess of the

roblem. A later study (Mowatt et al, 2002) looked at Honorary and Ghost

s published in the Cochrane Library, and found that 39% of

the ost

an

Lack of Independent Peer Reviewers

he independence of peer reviewers of papers submitted to medical journals is of

cies in place on

reviewers’ conflicts of interest. Fewer than 50% of biomedical journals have any

policy at all, and only 3% publish the reviewers’ conflict disclosures.90

The following two issues for medical journals have emerged in the last decade:

Ü The problem of finding peer reviewers who are independent of industry.

Ü The problem of industry ghost writ

submitted.

Papers by Industry Ghost Writers

Ghost writing in science has become more prevalent over the years. Med

often with a science background, either writing freelance or working for drug

companies or universities, provide papers for publication supposedly written by

scientists.

An informal poll by the American Medical

freelance writers had written at least one

person.84 A 1998 study of 809 articles found that 11% showe

authors, 19% had evidence of honorary authors and 2% had evidence of both.

They found that the ghost-authored papers were more likely to be found in smal

circulation journals, and they were more likely to be reviews.85 This study found that

one in four articles “demonstr

in

studies of this issue.86 87 88

The situation has not improved greatly, even with a growing awaren

p

Authorship in 577 review

reviews showed evidence of ghost authors and 2% had evidence of both gh

d honorary authors.89

T

importance with respect to validity. Many journals do not have poli


176

Ph

The direct-to-consum

pharmaceutical industry garners patient

rying media outlets, particularly print

and television, and

ed below).

lth

n, following an FDA request for comment on direct-

-consumer (DTC) drug promotion. This submission showed that, in 1988, US $25

re only likely to spend money on advertising if the campaigns

crease revenue. The drugs involved are often prescription-only drugs. Not only

rescribing habits of the physicians involved are also

changed by such campaigns.

icians

greed to such a patient request and would prescribe on demand.92

diture in 1999 rose by 38.5% from

the 1.3 bn spent in 1998, and was 33 times the amount spent on media advertisements in

arma and the Patient: Direct to Consumer Advertising

er advertising phenomenon is most prevalent in the USA and,

to a lesser extent, in New Zealand. The

support for particular drugs in two ways:

Ü The advertising of specific drugs in va

Ü The ‘third party technique’ (explain

In 1996, a submission was made to the Food and Drug Administration by the Hea

Research Group of Public Citize

to

million had been spent on DTC advertising, but that this had increased to between

$225 to $250 million by 1994.91

Effect of DTC Advertising on Doctors’ Prescribing Habits

Successful companies a

in

does the patient become more likely to ask for a particular drug following such

advertising campaigns, but the p

According to Public Citizen figures, in 1989 only 84% of physicians said they would

prescribe a particular drug if requested by the patient. By 1995, 99% of phys

a

According to Charatan:

Last year [2002] pharmaceutical companies spent $1.8 bn on ‘direct to consumer’

advertising mostly on television. Advertising expen

1991.93

Does it work? According to Charatan, it works exceptionally well:


177

ers that contributed most to overall drug spending. Doctors wrote only

5.1% more prescriptions for all other prescription drugs.

cription Advertising

he overwhelming success of Vioxx was attributed to its massive PR campaign.

s studying a proposal to relax the rules on advertising, allowing the

ompanies to simplify print advertisements to make them more user-friendly and

n

whether they have benefited in

terms of improved treatments?

Third Party Technique by PR Companies

Th t

op

On

Virus) test kit produced by a USA biotech company, Digene. In 2003, celebrities

an se of Commons in London to

of this test.

Doctors wrote 34.2% more prescriptions in 1999 than in 1998 for the 25 drugs promoted

direct to consum

Later figures (2003) now show a DTC expenditure of around US $3 billion per

year.94

FDA Allowing Pres

T

Following the failure and recall of Vioxx, the FDA in the USA has not restricted

companies’ ability to advertise.

In fact, the FDA i

c

summarising risks with typographical symbols. Prescription advertising has been

allowed by the FDA since 1997, and has grown to a business worth US $3.8 billio

per year in the USA.95

The most important issue, however, for patients is

e third party technique used by PR firms develops a ‘grass roots’ organisation tha

erates with no acknowledgement of the company it serves or that funds it.

e example of this ploy in Europe aimed at selling a HPV (Human Papilloma

d high profile women were enlisted to lobby the Hou

encourage the NHS to support the use

The Observer newspaper in London tracked the origins of this campaign to one of

the world’s largest PR companies, Burson-Marsteller, based in Brussels. The

celebrities contacted by the newspaper had no knowledge that they were in effect


178

Benefit for Patients?

ent for their

of

San Francisco.

t

ed as an industry also-ran. But the US company has powered its way up the

global ranking list to its unassailable position thanks mainly to its marketing prowess…

lar

travel expenses, and payments to doctors,

hospitals and universities in Vermont from the companies.

providing free PR for Digene by pressuring the UK government to introduce the new

screening test.96

The main concern for patients is that they receive the best possible treatm

cancers and have the best possible quality of life available to them. This does not

always occur—indeed, many prescribed treatments tragically have little chance

success.

Many patients with cancer receive chemotherapy at the end of life, even if their kind

of cancer is known to be unresponsive to the drugs, according to a study reported at

the (2001) annual meeting of the American Society of Clinical Oncologists held in

97

Dr Ezekiel Emanuel, at the American Society of Clinical Oncologists, noted that

treatment for a patient at the end of his or her life could cost $38,308 in the final

year, compared to $27,567 for a patient not in the final year of life. What kind of

financial burden may be left to families who have spent their life savings on

treatments for a family member dying of cancer?

Pharma and Marketing

If one company epitomizes the modern drugs industry it is Pfizer. Just a decade ago, i

was regard

...While some of Pfizer’s research has been excellent, its success stems largely from its

ability to turn drugs, often ones licensed in from its competitors – into multi-billion dol

products.

David Pilling (in a 2001 issue of the Financial Times)98

Pharmaceutical Marketing Budgets

The Office of the Attorney General in the State of Vermont has, for three consecutive

years, 2002-2005, released figures on pharmaceutical marketing in his state. These

reports document the monies spent on fees,


179

m the companies and do not include free

ional

July 1st 2002 to June 30th 2003:

44 companies spent $2.47 million with the largest spenders being

ive

physicians and other prescribers receiving 54% of the total.100

ventis and Merck.

These five accounted for 50% of the total expenditure. Physicians and other

410,404.102

hus this enormous marketing expense has been directed at only 0.2% of the US

a

004.103 The State of Oregon passed legislation requiring the disclosure of economic

all countries followed this procedure the amount of marketing money spent by the

g

Disclosures of these figures have come fro

samples, compensation for clinical trials, payments under $25, some educat

scholarships and grants for continuing medical education.

Ü

GlaxoSmithKline, Bristol-Myers Squibb, Merck, Forest Pharmaceuticals and

AstraZeneca. These five accounted for 72% of the total expenditure.99

Ü July 1st 2003 to June 30th 2004:

48 companies spent $3.11 million with the largest spenders being Merck,

Amgen, GlaxoSmithKline, Forest Pharmaceuticals and Eli Lilly. These f

accounted for 72% of the total expenditure. The largest recipients were

Ü July 1st 2004 to June 30th 2005:

68 companies spent $2.17 million with the largest spenders being Forest

Pharmaceuticals, Eli Lilly, GlaxoSmithKline, Sanofi A

prescribers received 81% of expenditure, with hospitals, clinics and

universities receiving 12% of the total.101

Vermont has a population of 623,050. The population of the USA is 296,

T

population.

Recently, the state of Maine approved new laws requiring manufacturers to file

annual reports with their Department of Human Services, beginning on 1 Janu ry

2

benefits provided by the pharmaceutical companies in 2005 with disclosures to be

made annually by the 15th February.104

If

companies would be more easily accessible, rather than being hidden under varyin

headings of expenditure.

http://www.acsh.org/







180

in ter (I believe) form of advertising has been used very

uccessfully: through supposedly independent ‘scientific’ expert groups or think

SH),

s,

en e t was

oposed as a means for bringing common sense views to the public.

the

itially they accepted no industry funding but in 1980 Dr Fredrick Stare, one of the

t.

risks

n, DDT and asbestos, to name just a few.

The ASCH has becom

sts of funding companies, past lists

ely reluctant to

rovide details of the monies spent on public relations (PR) in any form, whether on

upon by the state Pharmaceutical Cost Management Council in November 2005.

However, the move was challenged by the lobby group PhRMA on the grounds that

Marketing Through ‘Scientific Experts’

A slightly more s is

s

tanks.

One such scientific group is the American Council on Science and Health (AC

whose website is http://www.acsh.org/. The ASCH describes itself as “a consumer

education consortium concerned with issues related to food, nutrition, chemical

pharmaceuticals, lifestyle, the environment and health.” Founded in 1978 by a group

of scientists concerned with public policies being based on poor sci c , i

originally pr

ASCH began with a commission from Pfizer to write a paper on the ‘Delaney

Clause’. This is the part of the Food Additive Amendment of 1958 that restricts

addition of cancer-inducing chemicals into the food supply.

In

founders, contacted Philip Morris (tobacco company) requesting financial suppor

Since that time ASCH has produced papers and given interviews downplaying

from chemical pollutants, dioxi

e an influential journalistic source of commentary on public

health. Although they no longer publish li

include: The Bristol-Myers Fund, Inc., Ciba-Geigy Corp., Dow Corning Corp., E.I.

Du Pont de Nemours & Co., Johnson & Johnson, and Merck Co. Foundation.105

The pharmaceutical companies, naturally enough, have been extrem

p

advertising or promotion of drugs, gifts to physicians or direct-to-patient advertising.

A move to legally force this disclosure in West Virginia was unanimously agreed


181

ject to the Freedom of

est

sclosure laws between the pharmaceutical industry and health

rofessionals. In Vermont and Minnesota, payment disclosures are publicly

tify

maintained through market forces rather than by regulation.

orporation is convicted of repeated felonies that harm or endanger the lives of

human beings or destroy our environment, the corporation should be put to death, its

corporate existence ended, and its assets taken and sold at public auction.109

y large and yet do not

all company financial information is confidential and not sub

Information Act.106

Recent legislation in the states of Minnesota, Vermont, California, Maine and W

Virginia mandates di

p

available. A Mount Sinai School of Medicine study found in Vermont, that 61% of

payments were not released to the public as the pharmaceutical companies had

designated them as trade secrets and 75% of the disclosed payments did not iden

the recipient. In Minnesota, only 25% of companies reported data.107 108

Litigation

The commercial morality and ethics of pharmaceutical manufacturers has been

increasingly challenged by legal actions over the last few decades. It seems an

overly simplistic and naïve viewpoint that corporate ethics and social responsibility

would be achieved and

Corporations can be dissolved under charter revocation laws. As stated by New

York Attorney General Eliot Spitzer during a 1999 election campaign, when

commenting on these laws, if:

... a c

What follows is an account of some of the litigation involving pharmaceutical

companies over the last several years. Whether this is a relatively new phenomenon

or whether these companies have dealt in such a cavalier attitude with courts and

settlements through the life-time of their corporations is unclear.

When the monies paid out in fines and settlements are ver

appear to cause any financial distress to the companies—or induce better corporate

morality—it is difficult to imagine what would cause a change in their activities.


182

ing an investigation by the USA Attorney’s Office in Boston, TAP—

joint venture between Abbott Laboratories and Takeda Chemical Industries of

he charges related to TAP’s sales and marketing of the prostate cancer drug Lupron

ould fraudulently bill Medicare for

ents made through the Medicare and Medicaid

MO programmes111.

t in Boston against Abbott Laboratories Inc ,

ing overcharging of drugs estimated at more than US $800 million in 2000

discounts were given to doctors to encourage the use of

bbott’s drugs rather than those of their competitors.112 Doctors could buy Abbott’s

In 2003, Bayer agreed to pay US $257 million to the US government for supplying

Fraudulent Drug Pricing and Marketing Conduct: Boston

In 2001, follow

a

Japan— agreed to pay US $875 million relating to fraudulent drug pricing and

marketing conduct.

T

during the 1990s, when Lupron was competing for the market place with Zolodex,

another prostate cancer drug. Lupron was severely discounted or given as free

samples to doctors, with the intent that doctors sh

the drugs.110

Following the settlement of the government action against TAP, separate actions

have been launched by Empire Health-choice Inc., Blue Cross and Blue Shield of

Massachusetts to recover overpaym

H

In 2001, the Citizens for Consumer Justice (a coalition of consumer groups) filed a

lawsuit in the Federal District Cour

alleg

alone.

The allegations include discounts being given to physicians, ranging from 13% to

34% lower than the AWP costing and, in some cases, reaching between 65% to 85%

for particular drugs. These

A

drugs at reduced cost, sell them to their patients for the Medicare or Medicaid listed

price and pocket the difference.

Overcharging US Medicaid Through Relabelling: USA

the drug Cipro to Kaiser Permanente (a health care organisation) at a lower price

than Bayer was selling to Medicaid. This violates a federal law requiring the


183

to

Bayer hid the cost of the drug sales to Kaiser by relabelling the drugs and giving a

guilty to a criminal charge

,

l charges of overcharging the Medicaid

rogramme for their drugs Paxil and Flonase.113

62

ermany) and Rhone-Poulence (France),

mer director of worldwide

arketing for Roche (Kuno Sommer) was ordered to serve four months in a USA

to

above mentioned 1990s

itamin price-fixing cartel.116

, again in 2005, fined Astra Zeneca PLC

US $73 million for keeping the price of their ulcer drug ‘Losec’ artificially elevated

by blocking market access to generic versions between 1993 and 2000. According to

pharmaceutical industry to supply Medicaid with drugs at the lowest price charged

any customer.

false drug identification number. Bayer also pleaded

associated with the case.

GlaxoSmithKline, in a similar case involving relabelling of medicines for Kaiser

agreed to pay $87.6 million, settling civi

p

Rigging of Vitamin Prices: USA, Europe and Australia

Hoffman La Roche was found guilty of rigging vitamin product prices during the

1990s and in 2005 was ordered to pay fines of US $500 million in the USA and €4

million in the European Union.114

Roche Holdings colluded with BASF AG (G

over at least a nine-year period, to set prices of vitamins and ‘premixes’ used to

enrich cereals and processed food.

Rhone-Poulenc cooperated with authorities and therefore was not held criminally

liable for its participation in the cartel, however, the for

m

prison and fined US $100,000 for fraud. BASF was fined US $225 million for its

role in the price fixing.115

In Australia, a 2006 court action resulted in Roche BASF and Aventis agreeing

pay more than $30 million in compensation relating to the

v

Blocking Access to Generic Drugs: Europe

The European Union antitrust regulators


184

ons “constitute serious abuses of its dominant

Again in 2005, Bristol-Myers Squibb reached an agreement with the USA attorney

stors an amount of US $300

class

he company had been accused of ‘channel stuffing’. Channel stuffing is where

lied with the prosecutor’s demands.118

ff-Label Marketing and Conspiracy: USA

More recently, in August 2006, the

pa

tre

pro

sp

Sc er

$2 e ts of the investigation. With court approval

et to ratify this agreement, a subsidiary, Schering Sales Corporation, has also agreed

ement of

the EU officials, Astra Zeneca’s acti

market position” and that they gave “misleading information” therefore gaining

extended patent protection.117

Stockpiling Inventory to Overstate Revenue: USA

in Newark whereby Bristol-Myers paid to their own inve

million and, in a separate settlement to four investors who sued outside the

action, a further payout of $89 million.

T

wholesalers are paid to stockpile inventories, making it appear as if sales were higher

than the reality. This overstated their revenue by about $2.5 billion from 1999 to

2002. Bristol-Myers negotiated a ‘deferred prosecution’ where charges would be

dropped if the company comp

O

Schering-Plough Corporation was ordered to

y US $435 million for the off-label marketing of Temodar, a drug approved for the

atment of anaplastic astrocytoma (a brain tumour). Schering-Plough had

moted the drug for the treatment of other brain tumours and for cancers that had

read to the brain as secondaries from other tumours.

hering-Plough pleaded guilty to conspiracy in this case and agreed to pay a furth

55 million in resolution of civil asp c

y

to pay a criminal fine of $180 million following a plea of guilty to one count of

conspiracy in making false statements to the government.

This is not the first court settlement for Schering. Two years earlier a settl

$346 million was paid on charges of a kickback to a health insurer, protecting the

market of their allergy drug Claritin.119


185

ilar claims in court. The income from Seroquel in

n .

The most recent and largest legal action to date has been taken against multiple (16)

ultiple

st decade, the Defendant Drug Manufacturers have conspired with others in the

to physicians and hospitals

… to collect inflated prescription drug payments from Plaintiffs and the Class. More

e –

d and Corrupt

&

Multiple Ill-Effects of Drugs: USA

In 2005, Eli Lilly settled against 10,500 lawsuits relating to its anti-psychotic drug

Zprexa and its causing of diabetes or high blood glucose. Seroquel (AstraZeneca’s

anti-psychotic drug) also faced sim

the USA for 2005 was $2.8 billion.120

Conspiracy to Inflate Drug Prices: Class Action, USA

Legal actions against pharmaceutical companies are not only taken by the

government enforcement agencies, but increasingly are being filed by health plans

and consumer coalitio s

pharmaceutical manufacturers in the United States District court in Massachusetts.

This is a Class Action with five subclasses as plaintiffs. It was initiated by m

HMOs and Health Funds.121

Part of the allegation in this case is that:

For the la

pharmaceutical distribution chain, including but not limited

specifically, the Defendant Drug Manufacturers report to trade publications a drug pric

the Average wholesale Price (or “AWP”) – that for many drugs is deliberately set far

above the prices that these drugs are available in the marketplace. The AWPs for these

drugs are deliberately false and fictitious and created solely to cause Plaintiffs and the

Class members to overpay for drugs.122

Charges of breach of the US RICO law (US Racketeer Influence

Organizations Act) have also been brought against the defending companies.

The District Court filed notice of action against the following companies:

AstraZeneca, the Bristol-Myers Squibb group, GlaxoSmithKline, the Johnson

Johnson Group, and the Schering-Plough Group.


186

,

h, however, were set to go to

ial to answer the above charges.

nd Trademark Office: USA

laxoSmithKline settled in the USA District Court on 13 October 2005, over

nt and Trademark Office to obtain a patent for

Re

wa

‘Tr

To

bil nt to the US Internal Revenue Service over ‘transfer pricing’,

nies claim most of their earnings in countries where taxes are low. A

Our estimates would have shown that the

o $15

gs: Class Action, USA

onday 11 September 2006 saw the opening day of a USA federal trial in a class

were $909 million in the USA alone.126

l industry (2,875), the manufacturing industry (3,236), financial services

636) and the insurance industry (1,926) more harm appears to be done by big

One of the defendants, GlaxoSmithKline, agreed (with no admission of liability) to

a settlement payout of US $70 million in August 2006.123 Bristol Myers Squibb

Johnson & Johnson, AstraZeneca and Schering-Ploug

tr

Misleading the Patent a

G

charges of misleading the Pate

lafen, an anti-inflammatory medication. The amount of settlement in this case

s US $75 million.124

ansfer Pricing’ to Offshore Low-Tax Countries: USA

continue the GlaxoSmithKline saga, the latest payout for this company is a $3.4

lion settleme

whereby compa

company spokesperson, Patty Seiff, stated “

potential exposure here—total exposure—could have been $14 billion t

billion.”125

Inadequate Testing of HRT Dru

M

action brought by between 5,000 and 8,300 women against Wyeth, for failing to

adequately test for and warn of potential risks (including breast cancer) with the use

of their hormone replacement drugs Prempro and Premarin. The annual sales for

2005 of the two drugs

Pharmaceutical Industry has Highest Lawsuit Count in USA

The highest numbers of product liability lawsuits in 2005 were taken against the

pharmaceutical industry, with 17,027 cases. The USA is seen by many other

countries as being especially litigious. However, when compared to cases against the

chemica

(2

Pharma than most others.127


187

describe corporations’ control and domination of regulatory agencies

rough lobbying and selective information transfer.

ow much stronger must such ‘regulatory capture’ be when corporations are funding

the agencies?

ed against them; regulatory agencies tend to be understaffed,

I

rugs, Big Pharma has

ps with governments have llowed Pharma to operate with few

ing

O tical

industry, with m

ck

The term ‘regulatory capture’ was introduced by George Stigler, an economist in the

1960s, to

th

H

According to Bakan in 2004:

Many corporations regularly breach regulatory laws, confident that they won’t be caught

or that, if they are, the financial benefits derived from the breach will exceed the costs of

the fines assess

unaccountable, and peopled by bureaucrats – many of whom are drawn from the

industries being regulated – who see themselves as partners with industry, rather than its

overseers.128

Conclusions

n this chapter I have examined the growth in wealth and power of the

pharmaceutical companies. In spite of the decrease in new drug development over

recent years and the ongoing expiry of patents for existing d

thrived and continued to grow.

Close relationshi a

constraints. The courting of the medical profession has proven to be a formidable

marketing tool. Direct-to-consumer advertising has ensured public help in driv

pharmaceutical sales.

vershadowing all this is the high level of litigation involving the pharmaceu

ost of the major companies being under scrutiny for fraud, price

rigging, conspiracy, inadequate testing, and so on. It seems that the needs of the

patient for safe, affordable treatments are being sacrificed for the needs of the sto

holder.

In Chapter 7, Academic Freedom—Academic Funding, the relationships between

universities, governments and industry are examined, to determine if


188

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Pharmaceutica Court for the

District of Massachusetts. MDL No. 1456 Civil Action: 01-CV-12257-PBS.

123 Saris, J. P. B. (2006). Settlement Agreement and Release of the GlaxoSmithKline Defendants,

Un -

CV

124

http hatsNew.asp.

125 aker to swallow $3 billion tax bill. Marketplace. 11 September.

126 Schmit J (2006). More drugs get slapped with lawsuits. USA Today. 23 August.

7

12

n, United States District C

Amended Master consolida

l Industry Average Wholesale Price Litigation, United States District

ited States District Court For The District Of Massachusetts. MDL No. 1456 Civil Action: 01

-12257-PBS: pp1-70.

(2006). "What's New." Spector Roseman & Kodroff Retrieved 15 September 2006, from

://www.srk-law.com/CM/Custom/TOCW

Palmer H (2006). Drugm

12Ibid.

128 Bakan J (2004). The Corporation: The Pathological Pursuit of Profit and Power. London,

Constable & Robinson Ltd.

Changes in Cancer Research: Research Findings, Economics, Philosophy Jennie Burke – April 2007 Chapter 7 – Academic Freedom—Academic Funding

195

Chapter 7

Academic Freedom—Academic Funding

the

es of

as changed greatly over the last century. What

stigate fields of

of the foundation of universities for

istory of the University

The purpose of universities is to develop society's human resources, and to generate,

transmit, and disseminate knowledge1. Historically universities have had considerable

autonomy from regulation because they are supposed to foster academic freedom and

protect it from outside interference.

Marsha Woodbury2

In this chapter, I explore the university and government scientific institutes as

training grounds for future medical practitioners of oncology and as centr

research into cancer cause and treatments. In particular, I discuss the following:

Ü Funding for these institutions h

effect has this had on academic output?

Ü Have funding changes caused any conflict of interest in the institutions, and

how has this affected the quality and type of science in academia?

Ü What effect has the growing power of the pharmaceutical industry had on the

universities and institutes?

Ü To what extent is the patient—the end user of cancer treatments—benefiting

or being disadvantaged by these changes?

The concept of academic freedom—the ability to ethically inve

knowledge without repercussion—has been part

hundreds of years. Universities were established to foster this freedom and protect it

from outside interference, to explore the world around us without undue influence or

manipulation from external bodies.

H

The classical model of the university was a feudal institution, beginning in the 13th

century and changing little until the 19th century. Access to university was mostly


196

e of the

panied by the state actively promoting research at

universities as a supporting mechanism for the national economic interests of the

tion

belonged to the church. Patronage was defined by Burke as “the tribute

age. Thinkers of the

Enlightenment often had many patrons and did not feel obliged to produce to

s,

government institutes and capitalist corporations. Businesses have generally

fund research that would be critical of their activities or

at

fringements of the ‘right of autonomy’ of the university have occurred in the past.

een built into

niversity charters to protect the autonomy of the university from government

cience was once considered an altruistic search for the truth, for the greater good of

confined to the wealthy and was strongly allied to the church. The appearanc

research university3 was accom

country.

Over the last 2000 years, three models of intellectual process have prevailed in the

Western world:

Ü First came the monopoly of the Catholic Church over knowledge produc

and its distribution. Under the feudal system of the Catholic Church, all

opulence owes to genius” and by Rousseau as “the consideration riches owe

to talent”.

Ü The Renaissance and Enlightenment followed, when knowledge was

produced under royal and aristocratic patron

demand for any single patron.

Ü Now knowledge comes from the professional staff of universitie

not been expected to

products, thus bringing a change to the freedom of thought and expression.4

Autonomy of Universities Under Thre

In

For example, in World War II, the governments in totalitarian societies such

Germany, Italy and the Soviet Union,5 sought to impose their state/party lines onto

the activities of the universities, in both research and teaching.

In the face of these infringements, checks and counterbalances have b

u

interference and restriction.

But what of the choice of universities to sell their autonomy to industry? Academic

s


humanity. Today, much of this ‘free thinking’ science is being displaced by

‘controlled’ industry science.

197

Fo

eters and Roberts note the move from the traditional university to one closer to a

s

tive of international competitiveness.

amounts of funding from industry through collaborations,

Bias in Research Reports

Studies have repeatedly shown that research funded by ‘companies’ shows a much

unding company are reported quickly by the

searcher. However, if the trial has a negative outcome—for example, if the test

o

f even more grave concern is when negative results are not released.10 11 A report

t all.

llowing the Corporate Model

P

corporation, with its corporate language, mission statements, performance indicator

and focus on strategic planning:

Contemporary universities function as performance-oriented, heavily bureaucratic,

entrepreneurial organisations committed to a narrow conception of excellence generated

by the impera 6

Universities of the Western world have traditionally gathered funding from student

fees, government grants and donations and endowments. Now these institutions

draw larger and larger

contracts, and partnerships with the private sector.

Can autonomy be maintained by institutions that accept large amounts of money to

carry out research for the commercial gain of the donor corporations?

higher positive outcome for the products of those companies than studies carried out

by independent scientists or institutes.7 8

Trials with positive results for the f

re

product was found to be either harmful or non-beneficial when compared to a

placebo, or was shown to be inferior to another product (e.g. a drug)—it can take

twice as long f r the results to be published as for a positive result.9

O

on clinical trials for cancer therapeutics found that approximately one-quarter of

trials did not reach the public domain for many years after completion or not a


198

tive results are published this can distort medical literature and leave doctors

thinking a treatment is more effective than it actually is.

eigh the benefits. The risks are:

Ü Universities could become totally dependent on commercial funding if

tinue to decrease their contributions to university

d.

ey from the community in some form or

uch as the Guggenheim Foundation. These fellowships were

iven to graduate students wishing to gain research experience in their chosen fields

w st

f money continued to flow into universities, but

monolithic sizes; some campuses with their own police departments (in the USA),

Dr. Richard Sullivan, head of clinical programmes for Cancer Research UK, a

charitable organisation, commented at the group’s Festival of Science that:

If only posi

Although there may well be benefits from industry funding of clinical researchers,

the deleterious effect could far outw

governments worldwide con

coffers.

Ü The full and truthful reporting and publishing of results could be undermine

Ü The agenda of research studies could become driven only by profit and share

prices.

Governments, Grants, Endowments and Industry

Universities have traditionally taken mon

another. Fellowships and grants have been part of university income for the last

hundred years, contributing to the running of the university and to student support.

Fellowships in Science

Following World War 1, in 1925, ‘fellowships’ in science were established with the

creation of institutions s

g

and who met the criteria.

One of the first graduates to receive these monies as Linus C. Pauling, who had ju

graduated from the California Institute of Technology (Carter quoting Donas in The

Circuit Rider12). Pauling has delivered an exceptional return in science for this

modest outlay of fellowship money.

These somewhat small amounts o

only covered costs incurred by individual students. They did not provide the

increasingly large amounts needed to fund institutions that were growing to


and most with multiple research centres, restaurants and car parks. Grants, however,

were often large enough to assist at least in maintaining the existence of the

universities.

199

well as

nt Funding

the

e the major benefactor of

niversities. In 1940, the total USA Government support to universities was worth

a

unded approximately US $17.5 billion for

niversity research in 2000, with corporate sponsors contributing an estimated 12%

14

Cu

Fo und

ha e

‘re

fun

Corporate Funding in Australia

ost universities today accept funding from private sources, some for paid research

work and some as donations or endowments. Australia certainly has progressed

Prior to World War II, the total available funding for scientific research in

universities in the USA came mostly from these endowments and grants, as

from the fees charged to students.

Growth of Governme

The use of science (both good and bad) in World War II—the development of

nuclear energy, chemical warfare and leaps in physics research—and the growing

reliance of governments on the universities in wartime research projects changed

nature of funding. Following the war, government becam

u

US $31 million. Within 40 years, this support had grown to exceed US $3 billion. 13

The Advent of Corporate Sponsorship

During the late 1970s, money from corporations to fund research universities began

steady increase in the USA, rising from US $264 million in 1980 to over US $2.3

billion by 2000. The USA Government f

u

of research funding.

Research grants come from diverse sources. From the initial funding of the

Association of American Medical Colleges in 1876 to the mid 1970s, according to

15lbert (quoting Griffin in Medical Armageddon ), foundations such as the Ford

undation, the Kellogg Foundation, Macy Foundation and the Commonwealth F

d invested over a billion dollars in USA medical schools. By the 1970s, thes

search grants’ covered 16% of the costs of many USA medical schools. This

ding also directly contributed to the income of the research faculty.

M


200

he

he ABC television investigative programme Four Corners aired The Degree

s by

rofessor Ian Chubb, Vice Chancellor of the Australian National University (ANU),

ivatised. He stated that the Australian Government had

dollars in recent years.

nt of

s

slightly different view—of both necessity and outcome of this path—was

A lan Luke, Foundation

ean of the Centre for Research in Pedagogy and Practice at the National Institute of

Education, Nanyang Techn i Professor Luke stated:

In this whole process rporatis marke ot to make sure that

we actually protect the very core functions of the uni h are research and

teaching. We can’ reneuria t to be entrepreneurial for some sake …

Universities will lose their soul. They se some of their very powerful historical

functions as social forms of alternative knowledge, as sources of aesthetic and

intellectual activity th—the of thing that, as corporations come and go,

they’ll never be able to recover.

along the path, first established by the USA, whereby virtually all research institutes,

universities and medical schools now compete with one another for funding from t

private sector.

T

Factories (on 27 June 2005)16, exploring the monetary crises in Australian

Universities, with a discussion of the causes of and solutions to these problem

academics and students.

P

described the decrease in government funding as causing Australian universities to

become very heavily pr

decreased funding by billions of

Professor Peter Doherty (a Nobel prize winner, and a member of the Departme

Microbiology, Melbourne University) was also interviewed on the Four Corners

programme. He stated that Australian universities had not yet caught up to

universities in the USA in acquiring funding from private organisations, but that a

we become more entrepreneurially-oriented we will inevitably head further along

this path.

A

expressed in an interview for the programme by Professor l

D

ological Un versity, Singapore.

of co ation and tisation, we’ve g

versity, whic

t get entrep l jus

’ll lo

critics, as

and weal kind


201

ial

on.

. The next most

equently-mentioned daily activity was dealing with their budget and financial

To what extent have our universities been tran nanci utions that

are selling education?

CSIRO

and Industrial Research Organisation

oughly one of its total external income direct

dustry funding. This figure has been slowly increasing over the past 10 years. It is

Australia’s premier research institute b usiness to an increasing extent for

itself, rather than being a taxpayer-funded scie centre arches for

solutions and scientific advancement for the bene Australians.

RO give the following figures:18

Table 7-1: Funding of CSIRO

It is not premature to reflect whether our universities are already prioritising financ

concerns over educational issues. The Chronicle of Higher Education stated that

university presidents are more preoccupied with financial issues than with educati

How does this impact on the quality of education being offered?

A survey of 764 presidents of universities in the USA showed that more than half of

them spent a significant amount of each day on fund-raising

fr

matters. Only 29% of those surveyed attended to student matters on a daily basis.17

sformed into fi al instit

Industry Funding of

By 1996, the Commonwealth Scientific

(CSIRO) was gaining r -third from

in

highly unlikely, however, that the general public is aware that this has resulted in

eing in b

ntific research

fit of all

that se

The annual Reports for CSI

Year % Income External Sources (in $ million)

1993-1994 29.6 206.7

1995-1996 32.6 201.8

1996-1997 33.2 221.4

1997-1998 32.6 236.8

1998-1999 32.7 221.3

1999-2000 33.3 240.8

2000-2001 32.3 242.3

2001-2002 34.7 267.0


202

e enterprise

ompanies. Australian universities and medical research institutes also establish

p://www.dest.gov.au/sectors/research_sector/policies_issues

SIRO

in 2001

Medical Research CSIRO

CSIRO is also in the business of establishing ‘start-up’ companies, formed on the

basis of research completed in CSIRO laboratories and then sold to privat

c

‘start-up’ companies to provide revenue. Following is data from the Australian

Government’s Department of Education, Science and Training for the years 2001

and 2002 (taken from htt

_reviews/key_issues/commercialisation/nsrc.htm#table2).

Table 7-2: Commercialisation in Universities, Medical Research Institutes and C

Universities

n = 35

Institutes

n = 33

Start-up companies formed 46 8 10

% of companies in which equity was

held at the end of the year.

71% 89% 86%

Value of equity holdings ($m) 91.16 6.25 29.83

Table 7-3: Commercialisation in Universities, Medical Research Institutes and CSIRO

Institutes

CSIRO

in 2002

Universities Medical Research

n = 38 n = 35

Start-up companies formed 45 13 3

% of companies in which equity was 82% 92% 33%

held at the end of the year.

Value of equity holdings ($m) 85.95 10.69 18.99

This has the ring of a commercial business venture, rather than taxpayer-funded

institutions. In 2002 to 2003, the private sector invested $108.8 million in CSIRO

search. This was 40% of all external revenue, with $67.1 million (or 64%) being

We are on a journey from being an

ustralian research institution to a research enterprise with global reach.”19

re

spent by large companies.

On the CSIRO website, “Our Strategy” states “

A


Today’s emphasis in the CSIRO, and in our other academic institutions, is on ways

to increase commercialisation (see http://www.csiro.au/org/ps1gx.html).

203

Does the taxpayer lose anything by this? If research projects now need commercial

ry out the non-profitable

w up on so-called spontaneous remissions?

er?

Ind

he financial position of institutions associated with our major teaching hospitals is

e

Ü 5–13% of their income came from commercial collaboration,

ry ‘other grants’ was not explained in the financial report.

mbers of IP (intellectual

f potential

validation and to be able to show future profits, who will car

research. For example:

Ü Who will research non-patentable cancer treatments?

Ü Who will follo

Ü Who will work on the investigation of non-drug treatments for canc

ustry Funding of Teaching Hospitals

T

similar. The Garvan Institute of Medical Research is the research institute attached

to St Vincent’s Hospital. Based in Sydney, their financial reports show that for th

years 2000 to 2004:

Ü 15–18% came from the NSW Government,

Ü 21–25% came from ‘other’ grants, and

Ü 27–37% of their income was from NHMRC grants.

The catego

Melbourne is the home of the Walter and Eliza Hall Institute, another prestigious

centre of medical research. Whereas the annual report for 1997/98 shows

government support of the institute at 51%, by 2001 the Government funding had

dropped to 31%. To survive, the institute must make up this missing 20% support

from external sources (primarily the industry sector of the community).20

The report for 2003-2004 showed strong increases in the nu

property) transactions. This was attributed to the “growing identification o

commercial opportunities by our scientists.”21


204

e the end result of this commercialisation of our scientists in the health

rena?

ial World,22 raised the issue of changes in attitudes in

intellectual property. However, the

collaboration between industry and academia or the combining of private and public

tes

untries.

fessorships

country’s leading university, are financed by private

companies.

.

given these rights, even

ough some of this research is partially funded by the Swedish National Medical

newly appointed Dean, Dr Gordon Rausser, approached 16 companies with a

Should our science degrees now also include subjects from business and marketing?

What might b

a

Money and Ethics—Conflict of Interest

An anonymous editorial in The Lancet of March 2000, entitled Medicine’s Rude

Awakening to the Commerc

biomedical science:

Today’s universities are increasingly encouraging their scientists and doctors to be

entrepreneurs and to commercialise their

interest can easily end in tears.

Could an example be the restriction of research into only those areas of science that

will produce profits? This trend towards our universities and research institu

becoming commercial places of science appears to be occurring in most co

Private Funding at the Karolinska Institute in Sweden

In Sweden, even though the universities are state-owned, one-third of pro

at the Karolinska Institute, the

The Swedish newspaper Torsdag reported that Astra-Zeneca funds the salary of a

professor of neurology and, in return, has exclusive rights to his research. This

would give Astra-Zeneca the right to refuse publication to any research not

complimentary to their products or, if they so choose, to delay publication of results

Of more concern, however, is that Astra-Zeneca has been

th

Research Council.23

Private Funding at the University of California Berkeley

In 1994, the University of California Berkeley (UCB) found that the state

government would meet only 34% of their budget because of funding cuts. Their


proposal: The university would choose one company with which to form a research

partnership.

205

ging UCB an income of US $25

ed

t

Ü Novartis gained the ‘first right to negotiate a licence’ from any discovery

uld sit on the internal university research committees.

Ü Once confidentiality agreements had been signed by researchers, no

t from Novartis.

Plant

articipate in the

ovartis/UCB collaboration.

artis Collaboration

By t

be

led d Dean Rausser if the University would support a

culty member who had signed confidentiality agreements with Novartis, but who

ist

g did not change the agreement

The partnership went ahead with Novartis, brin

million over the next 5 years. Two-thirds of this funding was allocated for so-call

unrestricted research, with the rest going to infrastructure, costs and so on. The

agreement was as follows:

Ü UCB had rights to any patent coming from any research done by a UCB

scientist and the right to a joint patent if the discovery was made by a scientis

employed by Novartis.

gained by their paid research.

Ü Novartis researchers wo

publications would be possible without agreemen

By December 1998, most faculty members (30 out of 32) in the Department of

Microbial Biology at UCB had signed an agreement to p

N

Concerns from Senate Hearing Into UCB/Nov

2000, the Californian Senate was holding hearings on whether such an agreemen

tween industry and academia would engender conflicts of interest. The hearing,

by Senator Tom Hayden, aske

fa

wished to speak out on results as a matter of conscience.

The response was that the University had no duty or obligation to defend a scient

who broke their contracts with the company.24

The hearing raised concerns as to the compromised role of universities in being able

to deliver independent research. Although the hearin


206

ogy Boom and Tax Benefits

he growth of biotechnology has been a major driving force for the expansion of

echnological innovation. This Act was

followed the next year by the Economic Recovery Tax Act, which gave tax breaks to

ment to universities. It also promised tax

.

42% of all monies being put into US

niversities by big business.25

sional hearings were held to discuss the issues.

al

d Conflicts of Interest Hazardous to Our Health?—was

ining cases reflecting the problems of industry–university collaborations. The

between UCB and Novartis, it underlined the dangers that flow from universities and

industry becoming bedfellows.

The Biotechnol

T

entrepreneurial university science. In 1980, the Stevenson-Wyndler Technology

Innovation Act was introduced to encourage t

companies that contributed research equip

benefits for the development of collaborations between universities and business

Even by 1984, biotechnology research in universities was estimated to be worth US

$120 million per year, approximately

u

Congressional Hearings: Concern About Autonomy

At the time of these developments, politicians in the USA were aware of the potential

dangers inherent in this type of partnership. Between 1981 and 1990, several

congres

At one of the earliest hearings (in 1982), Congressman Al Gore, co-chair of the

proceedings, stated:

We return with a continuing concern that our universities, the source and foundation of

these technologies, may be permanently altered by the increasing number of commerci

agreements they are developing.

By 1990, a study by the US Congress House Committee on Government Operations,

Subcommittee on Human Resources and Intergovernmental Relations—Are

Scientific Misconduct an

exam

chair of these hearings, Ted Weiss, urged the Department of Health and Human

Services to restrict financial ties for researchers who conduct evaluations of products

and treatments in which they held vested interests.26


207

inherent

although the US government

ommittees called for stops and checks to be applied to such practices, the response

g that royalties gained from any discoveries patented by MSU

ould be shared between the two: 15% of royalties would go to the inventors, with

ation, research, experimentation, and education.” The revenue

rought in to Research Corporation by such deals was subsequently given out in

, Barnett Rosenberg and co-workers at MSU discovered Cisplatin,

r

ith over US $160 million in royalties.

This offshoot of Research Corporation, rather than using its income for providing

new companies, in the commercialising

pany,

So, more than 20 years ago, the US government acknowledged the dangers

in universities giving up their autonomy. At this time,

c

was minimal.

There has certainly been more and more public recognition of these issues, but the

problems and scandals continue to multiply.

Case Study: Michigan State University

In 1950, Michigan State University (MSU) signed an agreement with Research

Corporation, statin

w

85% split between the two partners.

Research Corporation was a charitable non-profit organisation, established in 1912

with the stated mission of promoting “the advancement and extension of technical

and scientific investig

b

grants.

In the early 1970s

which was approved in 1978 for the treatment of genitourinary tumours. In 1989, a

related compound of Cisplatin—called Carboplatin—was approved by the FDA fo

ovarian cancer treatment. Between 1978 and 1999, these two drugs had provided

MSU w

In 1985, Research Corporation established a daughter company, Research

Corporation Technology (RCT), to manage dealings related to ‘technology

transfer’.27

research, used it to invest in the creation of

and licensing of new discoveries. RCT became an independent, non-profit com


208

aying tax but with no shareholders. RCT now maintains royalty-sharing

ued

using

ties to invest in new scientific projects, but were giving

rge wage increases to high-ranking administrators within RCT.

ntract

have received the full 70% of royalties from the two drugs

d between the two parties prior to court, with RCT still

es.

rt

w uld otherwise be financially non-

iable.

artnerships, examples are provided below. Money buys compliance and may affect

p

agreements with over 100 universities in the USA.28

RCT and MSU both did very well from this arrangement until 1995, when MSU s

RCT and moved to terminate the contract. According to MSU, RCT were not

the profits made from royal

la

If this legal action had been successful, the termination clause in the original co

meant that MSU would

mentioned above.

A settlement was achieve

managing patent and licensing details, but with changes to the allocation of royalti

MSU received an increase in the royalties on Carboplatin (by 1999, worth more than

six times the royalties of Cisplatin). RCT also agreed to pay MSU $4.5 million over

the next two years.29

This was a somewhat toxic end to a blend of academia and the corporate world.

‘True’ Science?

An early naïve hope was that the monies allocated to universities in these ‘sweethea

deals’ would contribute greatly towards the costs of running the universities, and

would enable research to be carried out that o

v

It was also hoped that such alliances would not result in any unethical compromises

for the universities. However, documented examples do not indicate such clean

p

such fundamental principles of academia as objectivity.

Conflict of Interest at Harvard University

The prestigious Harvard University also has been besmirched with the taint of

compliance for cost.


209

d Corporate America’s Back Door to the Bush White House.

his report was released at the time that John Graham was nominated by Bush to

ublic Citizen was, however, concerned with the record of Graham’s role as

A, had solicited financial contributions

from a cigarette company while the centre agreed to downplay the risks of

ications.

t published by the HCRA also downplayed the risk to children

-A

ical companies producing these

chemicals.

uding DOW, Monsanto and Du Pont, and trade groups such

as the American Chemistry Council.30

in

dably

ccording to Marcia Angell,31 the Harvard Medical School once had the following

for

o other schools.

Public Citizen, in March 2001, released a 130-page report entitled Safeguards at

Risk: John Graham an

T

head the Office of Information and Regulatory Affairs, a part of the Office of

Management and Budget.

P

founding director of Harvard’s Center for Risk Analysis (HCRA). The report

showed the following:

Ü John Graham, on behalf of the HCR

passive smoking.

Ü HCRA had produced a report opposing a ban on the use of mobile phones

while driving. This report was funded by AT&T Wireless Commun

Ü The newslet er

exposed to pesticides and bio-active synthetic chemicals such as bisphenol

and phthalates. The newsletter did not, however, advise readers of the

funding received by the centre by the chem

Ü In 2001, the HCRA received funding from over 100 corporations and trade

associations, incl

Whether companies can give monies to a university and expect no consideration

return from the university is questionable. Most shareholders would understan

consider that giving donations without any expectation of a return would be naive.

A

strict guidelines for its researchers: They were prohibited from owning more than

$20 000 worth of stock in companies whose products they were studying. However,

this guideline has subsequently been softened, according to the executive Dean

academic programmes, to curtail the loss of key faculty members t


210

cademic Staff as Shareholders

nd

tanford University School of Medicine has no fixed limits of stock ownership for

e arge enough to

s of the company’s stock.32

ualms about questions of conflict of interest

tantial equity in this company, which is

also funding research at the university.

any research carried out for

the benefit of Seragen.

urther Conflicts of Interest

35

giving a sample size of 250 medical schools and institutes. These institutions

received over US $5 million in grants from the NIH and the NSF.

A

The Harvard story is not an isolated instance of ‘closeness’ between universities a

private corporations.

S

their academics. It is only when faculty members own more than US $100,000 in

stock, or own 0.5% of a company, that they must notify the university.

Massachusetts Institute of Technology’s ruling on this question is that notification is

only necessary when the academic’s equity in a company may b l

influence price

Boston University apparently had no q

when, in 1994, it established a spin-off pharmaceutical company called Seragen.

David Blumenthal reported in Growing Pains for New Academic/Industry

Relationships that:33

The university itself, individual members of its board of trustees, the president of the

university, and members of its faculty own subs

Positive results of research from the university would provide direct benefit to these

members of faculty. Surely this should raise questions of

F

Krimsky, in Science in the Private Interest34, lists the results of a 2000 national

survey on conflict of interest, showing 127 medical schools and 170 research

institutions receiving monies from the National Institutes of Health (NIH) and the

National Science Foundation (NSF).

In November 2000, the New England Journal of Medicine published a national

survey in relation to conflict of interest. The survey achieved an 85% response rate,


211

n respondents had no policy on conflict of interest. Of those respondents

ith such policies, 92% had instituted them after 28 June 1994, the date the federal

xistent. The

attitude and general response from the centres was “that the management of conflicts

etionary.”36

Funding from the Tobacco Industry

A

Ca funding from the tobacco industry in the

te 1990s. This figure may have been higher if the other five faculties of medicine

r

t

e medical research enterprise.

s or

Fourtee

w

draft guidelines on conflict of interest was released.

A further report, released by the General Accounting Office in November 2001,

found that at that time most universities left the decisions on conflict of interest up to

the faculty in question and that monitoring of compliance was non-e

and the penalties for nondisclosure were totally discr

Dirty Money

2004 study, published in the Canadian Journal of Public Policy, stated that 11 of

nada’s 16 medical schools had accepted

la

in Canada had agreed to disclose whether they also had received research grants o

donations from the tobacco corporations.

The study was conducted by the Ontario Tobacco Research Unit. The authors, no

surprisingly, warned that the acceptance of this money:

...may present major conflicts of interest that undermine public health and have

implications for the scientific integrity of th

Head of the research group, Dr Pamela Kaufman (PhD), stressed that the findings

may underestimate the links between tobacco companies and academia, because the

issues of specific faculty members accepting money for acting as expert witnesse

reviewers for the industry was not included in the study.37

Studies Show Industry-Positive Bias

Most now agree that universities accepting such funding from tobacco companies is

unethical. Professor Simon Chapman of the School of Public Health analysed 484


papers published in Indoor and Built Environment since the journal’s inception in

1992.

212

The analysis showed that 60% of studies on environmental tobacco smoke had

‘industry positive’. In 90% of these cases, at least one author was

e

te and

f the meeting (i.e. by 2001):

lated

to

ded that passive smoking is not harmful to health; this may be

artly explained, however, by the fact that 74% of these reports were written by

uthors with tobacco industry affiliations. The conclusion of this PHAA review was

at the only factor associated with this non-harmful finding was whether an author

was affiliated with the tobacco industry!39

The University of Sydney web site states that, from 1 September 2003, the university

will no longer accept funding from any tobacco manufacturer or agent.40 No reason

was given for the two-year gap between the suggested cut-off point of 2001 for

ceasing tobacco company funding—as per PHAA policy—and the date of the

University of Sydney Senate’s policy statement on this.

The figures given in relation to positive results of trials associated with funding from

the tobacco industry are uncomfortably close to the statistics on the pharmaceutical

industry funding of drug studies, both involving scientists with links to industry. I

findings judged

shown to have links with the tobacco industry. Professor Chapman stated that th

tobacco industry had a long history of using money and sponsorship to infiltra

influence both the scientific community and hospitality industry.38

Australia Phases Out Tobacco Company Support

The Public Health Association of Australia (PHAA), in their 1998 Annual General

Meeting, adopted the stance that the Council of the PHAA would, within three years

o

...take all reasonable steps to ensure that support from tobacco companies and re

entities is removed forthwith from the formula for calculating ‘Mechanism A’ funds

Australian universities.

This step was taken following a review of 106 scientific reviews of evidence on

passive smoking and health from 1980 to 1995. It is hard to believe that 37% of

these reviews conclu

p

a

th


213

am not suggesting that the use or sale of tobacco is the same as the use and sale of

pharmaceuticals, but rather that business is business and most companies will do

what they can to increase profits.

Conclusions

In this chapter, I have examined the relationships between universities, research

institutions, governments and industry. The changes in funding have created

academic institutions that are less and less independent and therefore less free to

provide unbiased comment and critiques of social developments. The science itself,

in many cases, may be tainted as the money buys the results required. As

governments decrease their funding of academia, the corporations are stepping in to

buy the science, with the benefits going to the stock holder rather than to the patient.

There is also a strong secondary effect of this partnering of universities and

industry—the education and training of our future medical doctors. The belief

patterns instilled in them by what must only be seen as the benevolence and natural

working relationship between doctors and the ‘industry’ is examined in Chapter 8,

The Philosophy, with particular emphasis on the current trend towards the use of

medical specialists in both private practice and salaried practices in research projects

funded by industry.

1 Flawn PT (1990), A Primer for University Presidents: Managing the Modern University, University

of Texas Press, Austin, TX.

2 Woodbury M (1994), 'Freedom of Information Laws Affect the Autonomy of American

Universities', Murdoch University Law, E Law: 1(4), viewed 2006,

<http://www.murdoch.edu.au/elaw/indices/title/woodbury_abstract.html>.

3 Stevenson M (2004), 'University governance and autonomy. Problems in managing access, quality

and accountability', ADB Conference, Denpasar, Indonesia, 26 April 2004, viewed 2006,

<http://www.sfu.ca/pres/president/speeches/20045.html>.

4 Andrew E (2005), 'Education and the Funding of Research', Techne: Research in Philosophy and

Technology 9(1): 44-54.

5 (2002), Microsoft Encarta Encyclopedia, Microsoft Corporation.


214

6 Peters M & Roberts P (1999), 'Globalisation and the crisis in the concept of the modern university',

Australian Universities Review, University of Auckland, NZ, pp47-55.

7 Djulbegovic B (2000), 'The uncertainty principle and industry-sponsored research', The Lancet 356:

9230.

8 Dieppe P (1999), 'Funding Clinical Research', The Lancet 353: 9164.

9 Ioannidis JP (1998), 'Effect of the statistical significance of results on the time to completion and

publication of randomised efficacy trials', The Journal of the American Medical Association 179: 281-

187.

10 Dickersin K, Chan S, Chalmers TC, Sacks HS & Smith H Jr (1987), 'Publication bias and clinical

trials', Controlled Clinical Trials 8: 343-53.

11 Rincon P (2004), 'Secrecy penalises cancer patients', BBC News, viewed 2006,

<http://news.bbc.co.uk/go/pr/fr/-/2/hi/science/nature/3632882.stm>.

12 Carter JP (1993), Racketeering in Medicine: The Suppression of Alternatives, Hampton Roads

Publishing Company, Norfolk, UK, p41.

13 Krimsky S (2003), Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical

Research?, Rowman & Littlefield Publishers Inc, Lanham, MD, p14 & 27.

14 ibid., p10.

15 Culbert ML (2000), Medical Armageddon, C & C Communications, San Diego, CA, p192.

16 Fullertown T (2005), 'The Degree Factories', Four Corners, Australian Broadcasting Corporation.

17 (2005), 'At Universities, a Funding Obsession', International Herald Tribune, from New York

Times, 4 November 2005, viewed 2006,

<http://www.iht.com/articles/2005/11/04/yourmoney/mbrf1.php>.

18 (2005), 'CSIRO: Annual Reports', viewed 30 June 2005,

<http://www.csiro.au/csiro/channel/pchew.html>.

19 (2005), 'Our Strategy', CSIRO, viewed 30 June 2005,

<http://www.csiro.au/csiro/channel/pchbf.html>.

20 (2001), 'Walter and Eliza Hall Institute: Annual Report', viewed June 2005,

<www.wehi.edu.au/about/annual_report>.

21 (2003-2004), 'Walter and Eliza Hall Institute: Annual Report', viewed 2005,

<http://www.wehi.edu.au/>.

22 Editor (2000), 'Medicine's rude awakening to the commercial world', The Lancet 355(9207): 857.

23 Krimsky S (2003), Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical

Research?, Rowman & Littlefield Publishers Inc, Lanham, MD, p10.

24 ibid., pp35-37.

25 ibid., p32.

26 ibid.

27 (2005), 'About Rectech', Research Corporation Technology, viewed June 2005,

<http://www.rctech.com/>.


215

Blumenstyk G (1999), 'A Company Pays Top Universities To Use Their Names and Their

rofessors', The Chronicle of Higher Education 45(41): A39-A40.

Chemcases, 'http://chemcases.com/cisplat/cisplat16.htm', viewed Jan 2005, 2005.

Krimsky S (2003), Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical

esearch?, Rowman & Littlefield Publishers Inc, Lanham, MD, p39.

Angell M (2000), 'Is Academic Medicine for Sale?' The New England Journal of Medicine 342(20):

516-18.

Krimsky S (2003), Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical

Research?, Rowman & Littlefield Publishers Inc, Lanham, MD, p48.

33 Blumenthal D (1994), 'Growing Pains fo /Industry Relationships', Health Affairs

13: 176-93.

34 Krimsky S (2003), Science in the Priva s the Lure of Profits Corrupted Biomedical

Research?, Rowman & Littlefield p49.

35 Van McCrary S, Anderson C ugh LB, Wray NP & Brody BA

(2000), 'A National Survey of Policies on Disclosure of Conflicts of Interest', The New England

Journal of Medicine 343: 1621-26.

ibid.

37 Sylvain M (2004), 'Study uncovers med school links to big tobacco', The Medical Post, 27 July

2004, 40(29).

38 (2005), 'Undue influence: smoking out the tobacco industry', Research and Innovation, University

of Sydney, viewed 2005, <www.usyd.edu.au/research/news/2005/feb/28_tobacco.shtml>.

39 (2005), 'NHMRC research funding and researchers who accept money from the tobacco industry or

parties acting on its behalf', Public Health Association of Australia: Policies Index viewed 2005,

<www.phaa.net.au/policy/NHMRC.htm>.

40 (2003), 'Tobacco Industry Funding', University of Sydney, viewed 2005,

<www.usyd.edu.au/senate/policies/Tobacco_funding.pdf>.

28

P

29

30

R

31

1

32

r New Academic

te Interest: Ha

Publishers Inc, Lanham, MD,

B, Jakovljevic J, Khan T, McCullo

36


216

PART IV

PHILOSOPHY

Changes in Cancer Research: Research Findings, Economics, Philosophy Jennie Burke – April 2007 Chapter 8 – The Philosophy

Chapter 8

217

The Philosophy

t to be supported by a narrow, selfish corporate spirit, by a

peculiar formality in dress and manners, or by affected airs of mystery and self-

ork and patients?

hat are the

indications of such differences?

s

e They the Same?

The field of ethics is based on principles that are regarded as true, and that therefore

cannot be challenged. Any concepts that challenge these basic principles are

dismissed as not worthy of consideration.2 This attitude leads to a dogmatic

I apprehend, this dignity is no

importance.

John Gregory 17701

In this chapter, I examine the philosophy of medicine as it applies to cancer research

and treatment, by asking:

Ü What effect could this philosophy have on cancer patients and on doctors’

attitudes to their w

Ü In what ways have changes over the last century been beneficial or

detrimental to both doctors and their patients?

Ü What cultural differences exist in philosophical attitudes and w

Ü In what ways has the philosophy of medicine induced changes in cancer

research?

Philosophy, when used in a particular field of knowledge, denotes the general law

and principles under which all the phenomena and facts relating to that subject are

comprehended.

A search of the medical literature using the search term ‘medical philosophy’ yielded

surprisingly few results. Papers have been written on medical ethics—bioethics—

but ethics is a subset of philosophy, a functional area rather than a self-reflective

stance.

Ethics and Philosophy: Ar


218

Any suggestions that basic

edical

chools; and the ‘brotherhood’ of medicine maintains this conformity throughout the

M

cli rstand and take into

ccount their patients’ psychology, attitudes, values and social standing; areas that

ecome quite set in their ways and do not easily deal with

change or challenges to their belief patterns. Dogmatism, which regards opinions as

a result of a radical paradigm shift.

ociety. The preparation required to become a

ember of that community—by being “rigorous and rigid”—enforces these beliefs

Such

he 19th century witnessed the introduction of ‘positivism’, which sought to separate

to

to rigorous testing.

approach that stifles critical reflection and innovation.

tenets may not be true and correct are vigorously opposed.

The indoctrination of conformity to these unquestionable ‘truths’ begins in m

s

professional life of a doctor.3

edical schools tend to focus primarily on the development of their students’

nical competence. However, physicians must also unde

a

receive much less attention in medical schools today. How can doctors perform

ethically for their patients’ benefit without this understanding?4

Resistance to Change

Most people tend to b

truths, is only likely to change as

Thomas Kuhn5 stated that a scientific community must have a set of received beliefs

to perform its role in science and s

m

strongly in the student’s mind. Challenges and changes to these beliefs must be

resisted by the establishment, for a change may introduce a new establishment.

is the nature and challenge of a paradigm shift.

T

science from any corrupting influence of subjective values.6 Medical science of the

20th century maintains a perception that it is based solely on fact. As we move in

an age of ‘evidence-based medicine’ this may increasingly become its reality.

Despite this, we still use many procedures and hold many beliefs that have not been

subjected


219

has changed, however, in medical thinking. The

evailed.7

veloped

as a

ely

ase,

nd physical data. In this

medicine

mology.

Doctors must make choices in therapy and in disclosure, choices that are based on

iefs, various needs and wants.

y: whether to

a

r philosophical stance of ‘service’ to the

patient.

linical encounters and choices arising from just laboratory reports form a rather

le to form a caring and

Conservatism in Medicine: the Cartesian Approach

For the last five decades, physics has shown that it is not only ‘matter’ that is

important, but also dynamics. Little

conservatism of medicine has pr

Our modern medical science has become a science of reductionism. George Engel,

has described scientific medicine as being based on:

...the notion of the body as a machine, of disease as a consequence of breakdown of the

machine, and of the doctor’s task as repair of the machine.8

This adherence to the Cartesian separation of mind and body—a concept de

over 300 years ago—has meant that medical science regards disease primarily

mechanistic breakdown; and cancer, as a cellular malfunction. Such a view is lik

to neglect the interaction of body and mind, both in the understanding of the dise

and in its treatments.

Moral Judgements in Medicine

Evidence-based medicine relies primarily on laboratory a

way, a positive feed-back loop is established that reinforces the belief that

is abstract, numerical and sterile.

The art of medicine, however—dealing with sick unhappy patients, with illness and

death—cannot be solely reliant on fact. It also requires a moral episte

individual patients, and on their bel

Treatment decisions are necessarily complex and must be made wisel

use a particular drug, to advise no treatment and offer palliation, or to listen to

patient’s enquiries about adjunctive treatments. These decisions are essentially moral

judgements and need to be based on a clea

C

sterile text. However, when the doctor and patient are ab


220

res

vis enough for them to see the patient as a whole

being, rather than just the disease?

Un

Th

Ho

ethicists. The num

but, in my experience, philosophy is rarely discussed at medical conferences.

of the medical

establishment. Their role, however, is limited to helping physicians to make

ut rights and wrongs in treatments or research projects, possibly to

are not

involved in discussions about why

pectful relationship, then the rich text of human encounter develops.9 But do

its to oncologists today last long

iversity Ethics Committees

e philosophers are not readily visible or eminent in the current medical system.

wever, universities have Ethics Committees; and some even have medical

ber of doctors who read papers on medical philosophy is unclear

Today, medical ethicists are regarded as essential members

decisions abo

minimise the possibility of litigation. They provide a service, rather than being

viewed as major components of medicine and medical practices.10

Ethics Committees decide whether the proposed study is ethical. Ethicists

treatments are done:

l of a treatment: To what extent is it the goal of the

How much of a patient’s informed choice is based on the type of information

eld

et of distinctive and defining problems.

With reference to those criteria, Caplan concludes that:

Ü What is the goa

practitioner or of the patient?

Ü What are the rights of the patient in the proposed treatment plan?

Ü

presented by their oncologist and on the way it is presented?

Does Medical Philosophy Exist?

In 1992 Caplan, from the Center for Biomedical Ethics, postulated that for the fi

of Medical Philosophy to exist it must fulfil the following criteria11:

Ü It must be well-integrated with other cognate inquiries and disciplines.

Ü It must have an established canon of key books, textbooks, anthologies and

articles.

Ü It must have a s


221

is fundamentally a normative enterprise. The aim of its inquiries is to

understand ethical problems in health care in order to make recommendations as to

philosophy of medicine tries

ss

edicine, all

at remains is a sub-section of philosophy, that is, ethics.

s an intrinsic part of medicine. The primary reason for the

medical students with the concepts required to address

s to become introspective or to develop

ical lives is seen as beneficial but not necessary.12

guidelines laid out in charters such as the Helsinki Declaration.

that sets out any form of philosophical stance states

ician to promote and safeguard the health of the

people. The physician’s knowledge and conscience are dedicated to the

e words, “the health of my patient will be my first

consideration,” and the International Code of Medical Ethics declares that, “A

care

ct of weakening the physical and mental condition

of the patient.

The philosophy of medicine as it currently exists fails to satisfy these criteria and, thus,

fails to exist as a field of inquiry...

...Bioethics

whether there is a need for normative change or not…. The

to examine how it is that doctors, nurses, public health experts and other medical

professionals believe or know things about health, disease, dysfunction, disability, illne

and suffering.

Until there is a clearly defined field and teaching of the philosophy of m

th

The Ethics

Ethics should be taught a

teaching of ethics is to arm

future patients’ problems. Enabling doctor

their own moral and eth

Helsinki Declaration

Doctors have sets of

The section of the declaration

that:

1. It is the duty of the phys

fulfilment of this duty.

2. The Declaration of Geneva of the World Medical Association binds the

physician with th

physician shall act only in the patient’s interest when providing medical

which might have the effe


222

y ethically be done to human

rld

Ü referral to colleagues,

In

pri

co

he naïve public perception in Australia, however, is that all doctors swear the

wearing of Oaths in Australian Medical Schools

Although medical practitioners may be read the Hippocratic Oath, they are not

required to formally swear to uphold the principles on graduation. (See Appendix 2,

The Helsinki Declaration, however, was never meant to provide a philosophical or

moral stance for doctors, but rather a list of what ma

subjects in the name of research. See Appendix 1, World Medical Association:

Declaration.

Australian Medical Association (AMA) Code of Ethics

On the web site of the Australian Medical Association (AMA) can be found its

(2006) Code of Ethics for Australian doctors. This code has been developed from

two sources: the Canadian Medical Association Code of Ethics and the Wo

Medical Association International Code of Medical Ethics.13

This code covers conduct relating to:

Ü the doctor and the patient,

Ü clinical research,

Ü clinical teaching,

Ü the dying patient,

Ü transplantation,

Ü the doctor and the profession,

Ü advertising,

Ü professional independence,

Ü the doctor and society.

the preamble to the code of ethics, the AMA states that this body of ethical

nciples is to guide doctors in the conduct of their relationships with patients,

lleagues and society.

T

Hippocratic oath on graduation.

S


223

.

Ü James Cook University15 students recite an oath written by the Medical

event, not a university function.

‘oath’ to recite at

a

ix

aring

practitioner, consecrating one’s life to the

ervice of humanity.

es.20 In the French

Code de Déontologie, it states:

ratic Oath, this oath has been established, nearly twenty-

ctor

here appear to be philosophical differences between English and non-English

Hippocratic Oath—Classical Version.) Depending on which university Australian

doctors attend, they may or may not swear an oath:

Ü The University of Western Australia14 does require swearing of the oath

Student Association.

Ü The University of Adelaide16 has a Declaration Ceremony at which an oath

may be taken. However, it is not compulsory to attend or to read the oath, and

the ceremony is an internal faculty

Ü At the University of NSW17 students write their own

graduation.

Ü Monash University18 and Sydney University19 graduates have not taken

formal oath in many years.

World Medical Association (AMA) Code of Medical Ethics

The World Medical Association International Code of Medical Ethics (see Append

3, Pledge—World Medical Association) has an almost identical list of guidelines to

the Australian code, with one interesting difference: the requirement for the swe

of an oath on admission as a medical

s

Both the British Medical Association and the American Medical Association no

longer require the swearing of an oath. However, oath taking on induction as a

medical practitioner is still carried out in many European countri

The new doctors take the Hippoc

five centuries ago, with rules that are always valid; probity and devotion of the do

who must preserve life, do no harm, respect the sick people, their interests, their private

life and medical secrecy, and be just.21

T

speaking countries in their attitude to oath taking.


224

,

ief in England is that an oath is sworn. In reality, this is not done, rather

octors are expected to adhere to a set of ‘Good Medical Practice’ principles.

c

ct was between the doctor and the patient: Either the patient paid for the

treatment or was treated as a charity case.

are answerable not only to their patient but also to the government that acts

ervice of medicine and

umanity. Although these guidelines are posted on the AMA web site, there is no

edical practitioners are not the only profession with a Code of Ethics. The

s

also

er, an oath is taken whereby the applicant sincerely

romises and affirms that they will truly and honestly conduct themselves, in the

practice of a Legal Practitioner of the Court, according to law and to the best of their

According to the Enquiries Officer at the General Medical Council of England22

popular bel

d

Although the major associations in the UK and USA do not require any oath be

sworn on admission, some universities, for example the Johns Hopkins School of

Medicine in the USA23, still continue the tradition (see Appendix 4, Hippocrati

Oath—Johns Hopkins University.)

Shift in Responsibility from the Doctor–Patient Contract

The Hippocratic Oath was developed in a market-place era of medicine, when the

contra

Australian doctors are now paid by government (from Medicare rebates), usually

with additional funds being contributed by the patient. However, this means that

doctors

as their employer. This creates a shift in responsibility and in the nature of the

contract between patient and doctor.

Doctors in Australia are now expected to follow guidelines for ethical behaviour,

rather than swearing an oath dedicating their lives to the s

h

requirement for Australian doctors to be members of the AMA.

Ethics in the Legal Profession

M

Statement of Ethics of the Council of the Law Society of New South Wales declare

that: “The true profession of law is based on an ideal of honourable service.” It

states that the legal profession serves the interests of justice.

On becoming a legal practition

p


225

ath or affirmation is taken that the

uth will be told. A witness is not asked if they hold a Code of Ethics that binds

giving

he taking of such an

oath.

tates:

s

he

s

dical students are less likely to report aberrant behaviour at the

25

External reviews of the inadequacy of health care delivery have been conducted at

at

lind eye to unethical and unprofessional

conduct by their colleagues.26

knowledge and ability.24 The same oath is sworn in all the states and courts of

Australia.

When evidence is given in a Court of Law, an o

tr

them to the truth. The swearing of an oath is to enforce the seriousness of the

of evidence, just as the swearing of the oath of service to the law enforces, for

lawyers, the seriousness of the profession they are entering.

The practice of medicine often entails life and death decisions, and is surely a

profession that should be taken seriously enough to warrant t

Protectionism Among Medical Practitioners

The fraternity of medical practitioners—the brotherhood of doctors—plays a major

role in the professional life of doctors. The Code of Ethics for Australian doctors

s

“Report suspected unethical or unprofessional conduct by a colleague to the

appropriate peer review body.” However, in the recent cases of the Campbelltown,

Camden and Bundaberg hospitals, it was the nurses who were the whistleblower

rather than the doctors. Nurses have invariably been the ones who have raised t

alarm when patients’ lives have been put at risk.

This attitude of the protection of the status quo begins in medical training. It ha

been shown that me

end of their medical training than at the beginning.

the Canberra Hospital (Australia), Mt Druitt Hospital (Australia), Royal Bristol

Infirmary (Britain) and Winnipeg Hospital in Canada. All reviews have shown th

the medical staff—the doctors—turn a b


226

ford University’s School of Medicine blamed the

ower

your patient.” This attitude needs to be instilled in

hat the

oath will always be upheld, but it does raise awareness and make possible the

ce caused multiple malpractice payments

the USA was carried out recently by Public Citizen. The study was based on

o or more malpractice payments were

disciplined by their state board.

Ü 14.75% of doctors who made four or more malpractice payments were

re

In 1976, Professor Holman of Stan

‘professionalization of medicine’ for providing an insulation from criticism and

alternate views, and for creating an establishment protective of its own social p

rather than the selfless pursuit of knowledge.27

The AMA’s Code of Ethics28, however, does state that the physician should:

“Consider first the well-being of

medical school and maintained throughout the professional life of a doctor.

Swearing an oath at the beginning of professional life does not guarantee t

enforcement of what that professional life should represent.

Self-Regulation within the Medical System

The medical system is self-regulating. Unless there is a breach of the law of the

land, any breech of the code of ethics is dealt with internally by the system itself.

The de-registration of a doctor, for example, is carried out only in extreme situations.

An analysis of medical disciplinary actions, such as license suspension or de-

registration, for physicians whose negligen

in

NPDB figures (National Practitioner Data Bank).29 Public Citizen found that:

Ü 89.61% of doctors who made tw

Ü 11.71% of doctors who made three or more malpractice payments were

disciplined.

disciplined.

Ü Only 33.26% of doctors who made 10 or more malpractice payments we

disciplined. This means that two-thirds of doctors in this group were not

disciplined at all.


227

Ye tem,

the

Ü Merck has provided funding for ethics centres in many countries.

m

Project.

airs in 2001 planned to

educate doctors about the ethical problems associated with the acceptance of

in a ‘do as I say not as I do’ manner?

es

ministration. This complaint followed the

ublication of an article regarding this conduct a recent issue of the The Australian.31

Conflict of Interest in Bioethics

Bioethicists are those who provide the framework for the ethics and therefore this

part of the philosophy of medicine. It is the Bioethicists who have written on

conflict of interest in medical practice and in research.

t monetary factors appear to have even invaded this sector of the medical sys

very core of medical ethics:

Ü Centres of Biomedical Ethics, such as the Stanford Center for Biomedical

Ethics, have had programmes funded by SmithKline & Beecham.

Ü The Midwest Bioethics Centre received half a million dollars in funding fro

Aventis Pharmaceuticals in 2000 to establish the Research Integrity

Ü The US AMA Council on Ethical and Judicial Aff

drug industry gifts. This educational programme was funded by monies from

Eli Lilly and Co., GlaxoSmithKline Inc., Pfizer, Astra Zeneca

Pharmaceuticals, Bayer Corporation, Procter and Gamble Company and

Wyeth-Ayerst Pharmaceuticals.30

It appears that ethics may be being taught

Doctors’ Relationships with Industry

It has become well publicised that it is unethical for doctors to accept gifts from

pharmaceutical companies, yet this publicity does not appear to have ended the

practice.

Drug industry rules suggest that hospitality provided to doctors at education events

should be ‘simple and modest’, yet Roche has recently been fined $75 000 for

spending $65 000 on wining and dining doctors at exclusive restaurants. The fin

followed a complaint to Medicines Australia—the drug industry’s overseer of

conduct—from the Therapeutic Goods Ad

p


228

onsumers of the products, they act as agents

r the consumers. It warned against the acceptance of product samples, as this was

g

e provision of lavish dinners

disproportionate to the content of the accompanying scientific presentation.

The guidelines were, however, fairly vague as to which gifts were acceptable and

rely that there is a “gradient of acceptability.”

n between the two has become blurred, and doctors find it

ery difficult to be clear about and maintain a healthy separation. When it is found

d

nsanto for many years. Doll was one of

e first epidemiologists to point to a clear link between cigarette smoking and lung

ic health.

dicine33 showed

at Doll had been secretly retained as a paid consultant by several international

In 1994, the Royal Australasian College of Physicians drew up and released their

guidelines on ethical relationships with the pharmaceutical industry32. It warned

doctors that, although they are not the c

fo

usually:

... a marketing exercise designed to accustom the physician to prescribing a certain

product or to establish a cohort of patients on long term treatments with a particular dru

...

... particular care should be taken in the light of a trend to th

which were not, saying me

Industry Funding Throws Doubt on Research Results

The medical structure appears to be so intrinsically tied to the pharmaceutical

industry that delineatio

v

that a doctor or medical researcher has accepted industry funding and concealed it,

because the potential bias cannot be accurately evaluated, the research results cannot

be regarded as trustworthy.

It has recently been revealed that one of the ‘greats’ in medical research, Sir Richar

Doll, had in fact been on the payroll of Mo

th

cancer. He became a figure of enormous standing in epidemiology and publ

A recent paper, however, in the American Journal of Industrial Me

th

chemical companies. At the same time, he was acting as an impartial scientific

expert investigating and reporting on suspected links between these companies’

products and the development of cancer.


229

uring the 1980s, Doll received $1,500 per day from Monsanto. This was during a

ge

ietnam servicemen who had been exposed to Agent

range. His statement that there was no evidence to suggest that the product was

hly suspect. He did not disclose at that

ly, a subsequent

ained

ning reduces mortality in

o

survival time but

oxifen with high risk women. (Note

mentioned above),

f

D

decade when Monsanto was at the centre of the debate as to whether Agent Oran

(a Monsanto product) is carcinogenic.

During this period, Doll gave testimony to an Australian Royal Commission

investigating claims by V

O

carcinogenic must now be regarded as hig

time or since that he was a paid consultant to Monsanto.

Paradigm Shifts

Signs of Self-Delusion?

When The Lancet published an editorial in 1993 entitled “Breast cancer: have we

lost our way?”34 we may have expected some intense soul searching into current

treatments and attitudes relating to breast cancer and, just possib

small paradigm shift.

The editorial pointed out that the overall mortality from breast cancer has rem

static and that there is no reliable data to suggest that scree

the youngest or oldest groups of patients. It also suggested that researchers were to

impatient to wait for the ultimate end-point of the disease—a long

usually with cancer recurrence causing death—instead relying on markers such as

disease-free survival and early diagnosis.

The editorial discussed primary prevention—not taking steps to prevent the

occurrence of a tumour, but rather using Tam

that uterine cancers can be a side-effect of the use of Tamoxifen.)

The author(s) also discussed secondary prevention—again, not true prevention but

rather early diagnosis through mammography—in the hope of finding cancers prior

to the expression of their metastasising potential. However (as

screening in this way does not reduce mortality in the younger or older groups o

women.


230

nge of Breast Cancer. Was the result of this conference a shift in treatment

po ‘no’,

as ny

for

apers presented included the following:

investigating adhesion molecules such as E-cadherin and the integrins.

ot been pregnant.

Ü Harry Burke from Reno spoke of outcome prediction as a new form of

5 hours

minimum per week had a protective effect against cancer.

Ü Breastfeeding gave a protective effect against premenopausal cancer, Clair

m reported.

l

ted out that, even though there may be

dissatisfaction with the current treatments, we should not dismiss the benefits

towards cellular regulation rather than cell killing.35

The editorial was written to announce the Lancet’s April, 1994 conference, The

Challe

ssibilities or in true prevention of the disease? My answer would have to be

little change eventuated following the meeting, and certainly it did not herald a

m of paradigm shift.

P

Ü Jim Devitt from Ottawa reminded attendees that breast cancer is only a

manifestation of a widespread disorder.

Ü Joyce Taylor-Papadimitriou and Ian Hart, both of London, spoke of

Ü Vincent Guinee of Houston noted that young women diagnosed with breast

cancer during or within a few years of pregnancy have a higher risk of death

from the cancer than those who have n

prognosis.

Ü Valerie Beral reported that there was no evidence to indicate that oral

contraceptives increased the risk of breast cancer.

Ü Leslie Bernstein of Los Angeles encouraged women to exercise, as

Ü N. Krieger of Oakland reported a nested case-control study dismissing the risk

of breast cancer from exposure to organochlorines.

Chilvers of Nottingha

Ü Michael Sporn of Bethesda spoke of primary prevention using severa

chemopreventive manipulations.

Ü Richard Margolese from Montreal poin

of ‘conventional’ chemotherapy and hormonal therapy.

Ü Harvey Schipper from Winnipeg urged that thinking should be moving


231

the post-conference editorial from The Lancet April 30,

994:

reactions of the conference participants … there were few signs of self-delusion and none

ciety web

page, the current standard treatments remain surgery followed by radiotherapy and/or

of Herceptin or hormone-blocking drugs.37

e ‘way was not lost’ stands up to scrutiny.

r

he public perception of prevention may be more about staying healthy and therefore

shift in cancer treatment but also offered a

odel and view of the cancer process.38

The final word came in

1

So, have we lost our way, as we asked in the Lancet editorial that announced the

conference in February of last year? With confidence we can say no, to judge by the

of self-congratulation.36

This conference took place over 12 years ago. Since then, the treatments and success

rates have shown minimal change. According to the American Cancer So

chemotherapy, with the addition

Little has changed in the last decade. The participants of the conference may have

felt no self delusion, but for an outsider it is difficult to see how the conclusion that

th

Prevention or Early Diagnosis?

A disturbing trend is the use of the word ‘prevention’ to refer to early diagnosis.

This concept of prevention has been used in the past in relation to mammography fo

women, and was again referred to at The Lancet conference, noted above.

T

not developing a tumour, rather than having a tumour already, but finding it early

enough to permit a more favourable prognosis.

Calls for a Paradigm Shift

A 1993 paper by Schipper and colleagues from the University of Manitoba,

Winnipeg, not only called for a paradigm

new m

They emphasised the need for a change from the current strategy of hoping for a cure

by killing every last cancer cell. This strategy regards the cancer as an entity, an


232

There are some new chemical agents that may re-regulate cells, such as inhibitors

metalloproteinase inhibitors to block the

en

ha

Op

hen attempting to introduce a new viewpoint in science one invariably must face

a

e similar to

cedure whereby doctors washed their

hands in a chlorine solution after autopsies and before delivering babies. The death

41

auling, the two-times Nobel Laureate, was

‘enemy’ that needs to be eradicated, rather than as a process of aberrant rather than

absent cell regulation.

Their view of malignancy describes cancer as a process rather than a morphologic

entity, thus questioning the long-standing concept of current cancer therapies.39

that block ras-oncogene activation and

zymes involved in tissue invasion.40 Sadly, the suggestion of “rethinking cancer”

s not produced any noticeable shifts in standard oncology treatments.

position to Paradigm Shifts

W

many hurdles. Pressure from peers to conform to standard perspectives is known to

influence not only funding possibilities, but also advancement in academic circles.

Opposition to new thought has been known throughout medical history.

Semmelweis, a Hungarian doctor working in Vienna, observed in 1847 the death of

colleague who had cut his finger during an autopsy. The symptoms wer

puerperal fever. Semmelweis instituted a pro

from puerperal fever at his Viennese hospital dropped from 13% to 2%.

Despite this success, however his actions were seen as a criticism of the hospital

director and Semmelweis’ promotion was blocked. He returned to Hungary,

continued experimenting (washing instruments as well), and wrote of his findings to

overwhelmingly poor reviews. He subsequently suffered a nervous breakdown and

died at the age of 47.

In our modern society, being known as a leading scientist does not make it easier to

challenge standard thinking. Linus P

repeatedly denied grants to study the use of Vitamin C in cancer treatments.42


Protecting the current status and monopoly of the medical profession has, at times,

233

oaching on areas

d slander was

Wilk vs.

in 1987, in which the judge found against the AMA for “systematic, long-term

43

ducation, and social

y. Man would indeed be in a poor way if he had to be

nt and hope of reward after death.

uotes)

When there

sis and treatment options, a happy

ween doctor and patient. However, if the outcome of

suggested treatments is not clear—because of poor prognosis or risk of severe

are ethically required to give patients full disclosure, thus encouraging the

atients’ fully-informed consent to treatments. This is often problematic for doctors,

e

any patients wish to rely solely on the advice of their oncologist, but they are often

s.

rtainty

satisfaction of their patients, and that:

taken regrettable turns. When chiropractors were seen to be encr

belonging to the medical profession, a systematic campaign of libel an

undertaken by the AMA in the USA. This campaign ended in a court case

AMA

wrong-doing with the long-term intent to destroy a licensed profession.”

A Doctor’s Philosophical Stance

A man’s ethical behaviour should be based effectually on sympathy, e

ties; no religious basis is necessar

restrained by fear of punishme

Albert Einstein (2006, in http://www.econsultant.com/q

Doctors are taught to maintain an air of confidence with their patients.

are clear outcomes in relation to a patient’s progno

relationship is maintained bet

adverse effects from the treatment—it becomes increasingly difficult for doctors to

maintain an atmosphere of certainty in this doctor–patient relationship.

Honesty in Discussing Treatment Options

Doctors

p

and can result in nondisclosure, poor discussion techniques and oversimplification.

Patients may misinterpret the doctor’s explanation of prognosis and treatment, or th

doctor may exhibit over-confidence in the treatment being recommended, and

discourage the patient from considering alternative treatments.

M

unaware of the level of certainty associated with the various treatment option

It has been claimed that doctors who are honest with patients about their unce

in the outcome of treatments are more likely to reduce the confidence, trust and


234

evelation of uncertainty.

y be undermined.

44

nd

Ü 84% informed patients of the absence of cure,

ith cancer

atients. I have often been surprised by statements they have attributed to their

ancer

nventional treatments. She was told: “If I had

om and they used proper treatment, at

This was a doctor trying to persuade a

Ü Patients may not understand the statistics relating to uncertainty of outcome.

Ü Patients may be harmed by the r

Ü The doctors’ authority and effectiveness ma

Ü If trust and satisfaction is undermined, patients may sue.

A 2004 survey on a group of patients with advanced cancer evaluated the content a

amount of information given to them by oncologists, as follows:

Ü 53% of the oncologists explained the course of the disease,

Ü 35% spoke of symptoms,

Ü 39% gave a prognosis,

Ü Watchful-waiting was discussed with only half of the patients,

Ü Most discussed ‘active’ treatment plans.45

Misinformation to Patients

Over the last 20 years, I have spent long periods of time in conversation w

p

oncologists, ranging from non-existent statistics to prognoses of x number of months

to live. Patients may be given informed consent, but do not usually have informed

choice.

One breast cancer patient informed her oncologist that she wished to treat her c

with natural therapies rather than co

100 women with your type of cancer in this ro

the end of five years 70 would still be alive, but if they used natural therapies at the

end of five years only five would be alive.”

As there has never been a study on breast cancer patients using only natural

therapies, this was patently untrue. There was no discussion about the type of natural

therapies the patient wished to use. It appeared that for that oncologist only

conventional treatment could be effective.


patient to follow standard protocols, possibly with the best interest of the patient in

mind, but with a blatant lack of ethics.

Oncologists Lack Interest in ‘Other’ Treatments

As discussed on page 121, surveys of Australian oncologists show that most lack any

detailed knowledge or understanding of ‘other’ therapies, such as complementary

and alternative therapies. Most patients find it difficult to discuss these therapies

235

ir oncologists, whose response they generally suspect will be dismissive.

erapies in conjunction with their orthodox

I

titioners, many of whom give such adjunctive

erapies to cancer patients. I asked their opinion on why oncologists do not feel

ere

een raised in the past. In a 1986 study, by

ere themselves diagnosed

with the

The issue is not that oncologists should be required to have this knowledge, but that

they should admit their lack of knowledge to the patient and if requested by their

patient, collaborate with those who do have this knowledge.

Many patients who have used adjunctive th

treatments and who have responded surprisingly well, have reported that their

oncologists have said: “keep doing whatever you are doing”. Nevertheless, to date,

have not been told of any oncologist who has asked for information on any of these

adjunctive therapies, with the view to assist other patients not doing well.

I interviewed a group of medical prac

th

obliged to offer all possible help to patients. Doctors MM and RB both felt that th

is enormous peer pressure to conform to conventional treatments and to offer all

standard protocols, partly to be seen to have ‘treated well’ and partly to avoid

possible litigation.

What Treatments Would Doctors Choose?

Whether oncologists would choose to undergo the same treatments they routinely

offer their patients is a question that has b

the McGill Cancer Center, questionnaires were sent to 118 doctors involved in the

treatment of non-small-cell-lung cancer. The doctors were asked which of six

randomised chemotherapy trials they would enter, if they w

with non-small-cell-lung cancer.


236

he

ors stated that they would not consent to a trial containing

Ü 58 of this 64 stated that they would not enter any of the trials offered because

47

ne

rs in

man or moral aspects. Thus they tend to rely on the scientific data—the

boratory results of tumour markers, scans and so on—rather than considering each

Informed Decisions

bout Medical Procedures: Doctor and Patient Studies49, in which they found that

hould

ce between what is possible and what is

esirable. Medical science in this past century does not have a history of offering

their decisions remain the same? If oncologists—who do understand the expected

Many of the doctors queried were involved in recruiting patients for trials and in t

trials themselves; 79 doctors responded to the questionnaire:

Ü 64 of the 79 doct

Cisplatin.

of the ineffectiveness of chemotherapy in this cancer and the unacceptable

level of toxicity.46

It is known that cytotoxic treatments that do not (and are not expected to) achieve

therapeutic benefit may be offered by oncologists. This is usually justified on the

basis of providing a degree of ‘hope’ for the patient.

Informed Consent or Informed Choice?

The difference between informed consent and informed choice lies at the heart of o

of the dilemmas of medical philosophy (as opposed to medical ethics). Docto

this scientific age increasingly rely on the technical aspects of medicine, rather than

the hu

la

patient’s situation in ethical terms.48

The Law Reform Commission of Victoria in 1989 published

A

information was given to patients to ensure compliance to treatment, rather than to

enable clear decision making by the patient. They found the common attitude

amongst doctors was that the patient’s best interests were served by the doctor

deciding what information should be provided and what treatment the patient s

undertake.

In terms of treatment, there is a vast differen

d

clear treatment choices to their patients.50 51

If patients truly understood the repercussions of the treatment plans offered, would


237

treatments, it is difficult to find a sound ethical basis for their suggestions that

rmed patient

agreeing to use this drug for ovarian cancer. The advertisement produced by Lilly

ay a patient’s decision—unless it is read quickly. It is

ior progression-free survival, in fact, a 49% improvement over

arboplatin alone. Bold letters again claim a 53% improvement in overall response

ificant (p=0.8977).”

ts of each treatment.

he GEMZAR/carboplatin group showed significant increases in most adverse

y

relative or friend with an infection. An increase in most of the unpleasant side

eported.

would be particularly arduous for most people. It is difficult to understand

side-effects and level of efficacy of the drugs—would decline to personally take

these

patients should do so.

GEMZAR: “Overall Survival Difference ... Not Significant”

I have previously mentioned the Lilly Oncology drug GEMZAR (in Chapter 2, A

Century of Cancer Statistics). It is difficult to understand a fully-info

Oncology is unlikely to sw

even more difficult to understand a doctor recommending this treatment to a patient.

The advertisement (see Appendix 5, GEMZAR Phase III Trial) provides data of a

randomised trial comparing carboplatin to carboplatin plus GEMZAR in patients

with advanced ovarian cancer. Bold letters announce that GEMZAR/carboplatin

offers a super

c

rate.

However, with continued close reading, one eventually reaches the statement:

“Overall survival difference between GEMZAR/carboplatin (18.0 months) vs

carboplatin (17.3 months) was not sign

The advertisement also shows a comparison of the adverse effec

T

effects, including anaemia, the need for blood transfusions, and an increase in

neutropoenia and leucopoenia (an abnormally low number of neutrophils and

leucocytes in the blood), which would require the patient to avoid contact with an

effects of chemotherapy was also r

GEMZAR may have given some of the patients an extra couple of month’s survival,

but at what cost? When faced with death, not being able to be close to friends and

relatives


238

t be to

sel

Th

In

pharmaceutical money on universities, research and the medical profession. The

on the best ways to invest, it is

xpected that impartial and proper advice should be given. When financial advisors

e,

oft back practices

has been of concern to ASIC (Australian Securities and Investment Commission) for

al planners received some form of commission 35% of advice

given was not reasonable, compared to 6% of poor advice given when

that all forms of commission—whether in the

rm of free office equipment, overseas trips, share options and cash bonuses—could

by gifts from

e pharmaceutical industry (see Chapter 6, Following the Money). However, there

how such a drug was ever approved for release or how difficult this drug mus

l.

e Ethics of Accepting Money from Pharma

Chapter 7, Academic Freedom—Academic Funding, I discussed the effect of

acceptance of money for favours is often disguised in diverse ways.

ASIC Recommendations

When financial advisors are consulted to give advice

e

take money from investment managers, this has been shown to influence the advic

en to the detriment of the investors. Investigation into these kick

many years.

In April 2006, ASIC released a report on financial planners, after surveying 306

instances of advice given to investors. They found that:

Ü When financi

commission was not involved.

Ü At the corporate level, when commission is involved 32% of advice given was

poor, compared to 11% with no commission involved.52

The recommendation from ASIC is

fo

influence the recommendations of the advisor, and need to be clearly declared53.

Influence on Prescribing Habits

Studies have shown that prescribing habits by doctors are influenced

th

still appears to be reluctance within the medical profession to resist this acceptance

of gifts.


239

a 2006 poll conducted by Medscape, the following question was asked:54

lunch

you favor or oppose the free lunch?”

6%, that is, 2748

were in favour from a total of 4823 responses.

nse from physicians only was 65%.

Cancer Care As a Corporate Entity

e University of California Berkeley wrote, in 1982, that

the

harmaceutical industry. Indeed, the connections over the last 25 years have become

drug-

large

orporate entity in its own right.

e business affairs of the doctors on its books and injects practices with

financial savvy and a competitiveness seldom seen in medicine.” 56

In

“Recent reports have described the practice of pharmaceutical companies providing

to medical practices while reps pitch their drugs to the physicians. The companies say the

lunches are modest and fall within industry guidelines. Opponents say that modest or not,

they still influence prescribing practices. Do

Responses to the poll were from physicians, pharmacists and nurses:

Ü The total response in favour of accepting a free lunch was 5

Ü The respo

In the words of Shirley Chisholm (2006, in http://www.econsultant.com/quotes):

When morality comes up against profit, it is seldom that profit loses.

Professor Fritjof Capra of th

healthcare needed to be liberated from the pharmaceutical industry, and that drugs

would eventually be used sparingly and as specifically as possible, and only in

emergency cases.55

Unfortunately, healthcare has certainly not yet become liberated from

p

even more tangled, and there has been no major move away from our current

based medical system. In fact, at least in the USA, cancer care has become a

c

US Oncology is a large cancer care service company. Founded in 1999, it now

manages 1,000 oncologists and treats one in seven cancer patients. US Oncology

manages th

“

US Oncology is now the largest purchaser of chemotherapy drugs and can negotiate

a 24% discount on the wholesale price of the drugs. This contributes to the profit

margin of the company, which in 2005 showed revenue of US $2.5 billion.


240

h as PET

canners and linear accelerator machines, which would be turned over to oncologists

te medicine with a view to the profit margin, rather than

medicine as an art, with a view of the patient as the sole recipient.

,

eakthroughs in treatment, of the

eed to fight the war: the War on Cancer. That these reports are from ‘experts’

role of the doctor was to encourage healing and ease pain. In the

urrent system, a doctor’s role is to diagnose ‘illness’—whether the patient is aware

d

n to breast

ancer—has changed the way we relate to our bodies. The historian Barbara Duden

has examined the diaries and letters of 18th century women. She found that women

of that era considered health and sickness as being to do with the flow of blood.

The company also sells data on patients, and consults with the pharmaceutical

industry. There is now a move for the company to purchase equipment suc

s

for a cut in the profit from the machines.

This is certainly corpora

The Patients

Socially, we have changed in our view of cancer. The mass media’s continual

reference to ‘cancer cures’, ‘cancer risk’ and ‘cancer prevention’ have brought to the

forefront of our thinking a sense of living with risk and the inevitability of risk

management.

‘Experts’ Promoting Fear

We are continually bombarded with appeals for money to fight cancer: Daffodil Day

Pink Ribbon Day, CanSurvive Day, and the list goes on. Experts are seen on

television and heard on radio, talking of the latest br

n

makes their message seem both more credible and more frightening.

This promotion of fear generates millions of dollars for research centres and

hospitals, and provides income for members of cancer societies worldwide.

Historically, the

c

of it or not—and then treat the illness with purchased products. This is disease-base

medicine.

For women, the constant promotion of fear—specifically in relatio

c


241

he

ippocrates: congestion, non-movement, an internal non-flowing.

ancer patients are the end-users of oncology. In commercial terms, it is usually the

ology

petition in the American small-car market from

o

egan, engineers at Ford discovered a flaw in the design that

aused the Pinto fuel system to explode easily on rear impact. At the time of

n to the design to ensure safety would take the car over these

pecifications.

mates were that each death would cost

the company $200 000, each major burn injury would cost $67 000 in compensation,

be $700.

Women went to doctors not because they were ill but because they felt ‘blocked up

inside’. They were motivated by fear of blockages. This was also the fear from t

time of H

Present-day society has made our breasts a matter of concern, of fear, of risk of

possibilities that may never occur, of malignancy—a fear of possible disease that

may never eventuate.57

Patients As End-Users

C

end-user who chooses the products they will use, but this does not occur in onc

or in medicine generally. Patients rely on third parties—the oncologists—to decide

for them which treatment protocol they should undertake. In other fields this is not

the situation. The Ford Pinto story is an example of consumer power.

Consumer Power: Ford Pinto

In the 1960s, Ford faced strong com

Volkswagen and Japanese competitors. Ford rushed through production of the Pint

in 25 months, when the usual time was 43 months.

Before production b

c

manufacture, Lee Iacocca was head of development. He had specified that the car

was not to weigh over 2000 pounds and should not cost more than $2000.

Modificatio

s

It was estimated that there would be potentially 2100 burned vehicles, causing 180

serious burn injuries and 180 burn deaths. Esti

and the average repair cost for each car involved would


T

242

o correct the fault would cost the company $137 million—$11 per car—which was

ar

te and

e cost of settlements would have been closer to the cost of correcting the problem.)

ade 24% of the cars on

merican roads, yet 42% of collision-ruptured fuel tanks were occurring with Ford

y 1972, the NHTSA had been researching and analysing car fires for four years.

a

the Pinto. One month later, Ford recalled 1.5 million

ad been a conscious decision to put profit before human lives.

ere low for many years after this.

much greater than the cost of compensation and other payouts, calculated at $49

million.

Ford’s cost-benefit analysis found that it was not profitable to make the $11-per-c

changes to the car. (Experts later found that their calculations were inaccura

th

The safety issue was dismissed, as it was decided that trunk space was a larger issue

in the competition to sell cars.

A report by Eugene Trisko, prepared for the national Highway Traffic Safety

Administration (NHTSA), found that the Ford Company m

A

cars. The NHTSA also commissioned a report by Robert Nathan and Associates,

who found that 400,000 cars were burning each year, causing 3000 deaths through

burns.

B

Over that period there had been 9000 deaths and tens of thousands of injuries

involving burns and scarring. This four-year delay allowed over 10 million unsafe

vehicles to be sold.

In May 1978, the Department of Transport, a division of the NHTSA, announced

‘safety related defect’ in

Pintos.58 59

This scandal came close to destroying the Ford motor company, as consumers

realised that there h

Ford sales w

Consumer Lack Of Power In Medicine: Merck/Vioxx

The Ford Pinto scandal is somewhat similar to the Merck/Vioxx situation, in which

Merck failed to alert consumers to the potential for cardiac adverse events associated

with the use of Vioxx.


243

tage trial, eight patients suffered heart attack or

sudden cardiac death, compared with one taking the rival drug Naproxen. This

significant, but Merck did not disclose

mail messages from Dr Edward Scolnick, Merck’s leading scientist, and from Dr

cerns

e

s study could result in the FDA

emanding that the Vioxx label indicate its cardiac risks.

ter the trial and asked to edit the paper.60

ed

tion about the safety of

ey were told not to discuss heart risks associated with the drug with

doctors.61

ciding not to

urchase a particular manufacturer’s product—and patients, who are consumers of

t

During a clinical trial, the Advan

difference in adverse events was statistically

the data. An earlier study, the Vigor study, had also showed that patients taking

Vioxx were more likely to suffer heart attacks than those taking Naproxen.

E

Alise Reicin, vice president for clinical research, indicated that Merck had con

about data that contradicted the safety of Vioxx. In one of Dr Scolnick’s emails, h

expressed concern to other Merck scientists that thi

d

The Advantage trial was published in 2003 with Dr Jeffrey Lisse as first author. Dr

Lisse later declared that, although he was listed as first author, the report had been

written by Merck, and that Merck had designed, paid for and run the trial. He had

been approached af

It has also come to light that Merck attempted to reformulate Vioxx by the inclusion

of a thromboxane inhibitor to provide cardiac protection, filing a patent application

in 2001. According to Rep. Henry Waxman, a review of Merck documents show

that:

Ü 3000 sales people were given misleading informa

Vioxx.

Ü They were instructed to show physicians a pamphlet indicating that Vioxx

might be 8 to 11 times safer than other anti-inflammatory drugs.

Ü Th

There is a large difference here between consumers of cars—de

p

drugs, but who have no say in which manufacturer’s product they use. Patients mus

rely on their oncologist/doctor to make this choice on their behalf. They have some


244

,

ance of Merck has also exposed corruption and weaknesses

the government agencies responsible for regulating the companies and their

rised 32 members, of whom 10 had previously

een paid consultants to the drugs’ manufacturers.

ce

e

the risk of heart attack

nd sudden death.

o

the

Patients put their faith and trust not only in their doctors, but also in the government

aceutical industry. If neither manufacturers nor

ercy

e,

consumer power in medicine: They can change doctors, but this is their only voice

their only source of any choice.

Lack of Impartial Government Regulation

Uncovering the malfeas

in

products.

The FDA advisory committee that voted to continue to allow sales for Cox-2

inhibitors, including Vioxx, comp

b

Much of the information on the FDA’s inaction relating to Merck and Vioxx have

come from a whistleblower, Dr David Graham, a scientist with 18 years experien

working at the FDA. Dr Graham performed a 3-year study with Kaiser Permanent

and concluded that high-dose Vioxx significantly increased

a

Senior management at the Office of Drug Safety attempted to pressure Graham int

changing his conclusions and recommendations. When he resisted this pressure,

FDA refused clearance for the publication of his findings. Shortly after this, the

FDA approved Vioxx for use in children with rheumatoid arthritis.62

Patients’ New Role in Their Own Health Management

agencies that regulate the pharm

government agencies show complete trustworthiness, then patients are at the m

of both.

There is, however, a growing change in the patient’s role in their own health

management, as we enter a third age of information transfer.63

The first age of information transfer was the age of the book, when widespread use

was limited to the elite. We have seen this limitation continue in medical scienc


245

have

To be published in these journals, the

formation must conform to the positions and standards of the ‘gatekeepers’, the

on one’s wealth status)

but information placement is costly. Those with the largest budgets have their

are their stories with other patients. This scale of

patient story-sharing has never been experienced before, and it is starting to have

b n

ncologists, who may only have told them what they felt they

eeded to know. They edited information and often felt that the best interest of the

hanging View of the Doctor

were seen to be endowed with paternalistic qualities,

nd their decisions were acknowledged as being authoritarian and unquestionable.

l e as

where information has remained the prerogative of the elite. Patients rarely

access to full print papers or journals, and the information in these is extremely

specialised, with its own elitist language.

in

editors and reviewers.

The second age of information transfer came with the introduction of television.

Access to television is potentially available to all (dependent

information viewed most often.

The third age is the age of Internet. This new information source has caused the

largest change for patients, where they can now not only access enormous amounts

of information but can also sh

large effects on the treatment choices patients may make.

The quality of information from the Internet is often problematic, ut patients ca

now access abstracts of papers through PubMed and many spend vast amounts of

time learning about their own particular types of cancer. Patients once relied on

information from their o

n

patient was served by the doctor making the decision as to which treatment was best

suited64.

C

Our society has taught us to respect physicians. We grew up with television

programmes that idealised doctors. We watched Dr. Kildaire and others walk the

corridors of hospitals, saving lives and bestowing their blessings on the common

folk. The medical profession

a

To some extent this no longer holds sway, but doctors are stil not treated the sam

veterinarians, engineers or others with a good education. Most people have no


problem with gathering multiple opinions on fixing their cars and electrical

appliances, and with sacking and changing their legal representatives. However, the

choice of doctors does not seem so easy.

246

ve not been happy with the

ist,

e

ws death in ways different both to our ancestors and to non-

estern cultures. In many less industrialised cultures, death is still viewed as an

Our Western culture focuses primarily on living. For most, dying well is a concept

t until we have no other choice. We run

the availability of hospices and the legal right of patients to

fuse life-sustaining care.

gnity, loss of control and of being

burden on their loved ones.

l beliefs.66 Quality of life is

lative to individual patients rather than being an absolute assessment, but often

Many of the patients I have spoken to over the years ha

oncologist treating them. But they have often baulked at seeking another oncolog

in case the first was offended or the second may have been friends with the first. Th

end result is that the patient is unhappy with their treatment.

Fear of Death in Modern Western Culture

Our modern culture vie

w

essential part of life—part of the human experience—that cannot be avoided.

Planning for a Good Death

that is neither spoken of nor thought abou

from death and are taught to fear it, rather than plan a good death.65 Our social

structure is built on the denial of death, our anti-aging medical movement and the

celebration of youth. We are not taught how to deal with dying people, whether they

be relatives or friends.

The last three decades have witnessed various attempts to improve the quality of life

of dying patients, with

re

Medically, the attempt to ease dying and improve care for the dying patient has been

mostly to do with technology for symptom relief. However, surveys of patients

indicate that their concern is mostly about loss of di

a

The experience of dying is not purely physical but is psychological as well, taking in

social relationships, hopes, expectations and spiritua

re


247

r

ts

ainst Length of Life

We now live in a society where death is no longer considered a natural event but

e the dying person was surrounded

lity

nd function. We now undergo aggressive care, rather than accepting death and

o ethics committees examine the effect of treatment rather than the nature of the

ng

ite

different attitude to cancer patients. Many of the clinics I have visited use art and

part

n

e overthrow of communism when hospitals were very poorly funded. I remember

when palliative chemotherapy is offered it is regarded by patients as still striving fo

length of life. There is often a tendency in palliative cancer treatment for oncologis

to focus most attention on discussion of an ‘active’ treatment programme.67 68

Balancing Quality of Life Ag

rather an enemy. Once a ‘good death’ was wher

by their loved ones and died in their own bed peacefully. Death is now regarded as

the enemy and the extension of life is seen as worthwhile, even at the loss of qua

a

taking palliative care.

D

action that brought that effect?69 Should skilled support in other ways, such as

emotional support, help patients face the reality of a cancer beyond cure?

European Attitudes to Cancer Patients

When attending oncology conferences in Germany and Austria, and when visiti

cancer clinics in those and other European countries, I have found that there is qu

a

drama therapy to help a patient express the emotions, fears and concerns that are

of the diagnosis of cancer. In Denmark, a cancer clinic headed by Dr Fin Anderse

holds a weekly dance for, as Dr. Andersen remarked, “How can patients get well if

they are not happy?”

In 1991, I attended a conference in Moscow and was invited to meet for lunch with

Dr. Eugene Stranadko, a leading oncologist in Moscow. This was during the time of

th

there being holes in the walls of the oncology unit.

Dr. Stranadko spoke of having healers working the wards with the patients,

particularly prior to surgery. He said he did not believe that this really did anything,

but he allowed it as it made the patients feel better.


248

hether the healers caused any effect is not the point. Rather, allowing the use of

ing

icine

her book Medicine and Culture, examined differences between

bed the French system of medicine as being Cartesian in its love of logic

nd theory, and as more inclined to emphasise the importance of aesthetic, sexual

elings rather than thinking. German doctors have always been more holistic in

.

f the

ody and that the spiritual world of the body must be healed as well as the physical.

peration. The British tendency is to equate the cause of disease as being external.

W

harmless treatments—solely to enhance the patient’s sense of well-being—is very

much to the point. I cannot imagine a hospital oncology ward in Australia invit

healers into the wards with the blessing of the oncologists, simply because this

makes the patients feel better.

Cultural Differences in Science and Medicine

There are strong cultural differences worldwide in our views of science and med

and, to a large extent, our cultural backgrounds help to define our philosophy.

Lynn Payer, in

English, German, French and North American (USA) medicine.70

She descri

a

and psychological concerns. The French have always valued the thinkers of their

society. French medicine has long been concerned with the terrain of the body, and

treatments meant to boost the body’s own resistance to disease have long been

practised. Immunotherapy for cancer treatment fits well into the French psyche.

The German medical thinking, however, has romanticism at its core and values

fe

their approach to medicine, and are more inclined to look at the whole rather than

just part of the body. A large percentage of German doctors practice homeopathic

medicine and the work of Rudolf Steiner is still held in high regard in Germany

Steiner taught that disease was caused by an imbalance between the polarities o

b

Payer found that British medicine was dominated by a sense of economy. Where

French surgeons were disinclined to radical mastectomy because of their sense of

aesthetics, the British surgeons leaned towards lumpectomy as it was an easier

o

Disease was often regarded as a malevolent entity outside the body, owing nothing to

the terrain.


249

h

n medicine

ppeared to be a result of a difference in the types of students attracted to a medical

social

e

hether cancer patients are now offered the very best treatments possible remains an

ccurred since the

dvent of chemotherapy. There is no doubt that surgery has improved in many ways,

h

own

yet overall—for the most common

ancers—improvement in cure rate or long term survival is depressingly low.

appears

.

onsultations do not allow time for a patient’s wants and needs to be truly

he cessation of swearing an oath on admission as a medical doctor may, in the long

term, make no difference to the morality of the delivery of medical treatment, or to

Medicine in the USA, however, was found to be aggressive and often invasive, wit

an overwhelming need to be doing something, often as much as possible. The

presence of many self-described ‘type A’ personalities in America

a

career. The attraction of being a doctor in the USA was often because of the

and academic prestige. Fear of litigation has influenced much of American

medicine, with a need to act being preferable to a watch-and-wait attitude. Th

‘more is better’ philosophy of American society is reflected in their medicine.

Conclusions

W

issue, not only for the patients but also for the families and the medical teams

involved.

Very few significant changes in treatment types and styles have o

a

with new guided imaging techniques, and radiotherapy has also improved, yet bot

still have inherent after-effects and dangers for the patient. Chemotherapy has sh

its worth strongly in some of the rarer cancers,

c

The philosophy of medicine is taught to students in the form of ethics, but it

to be a dogmatic approach that does not encourage innovation and introspection

New approaches are vigorously opposed and adherence to a standard format is

enforced. The medical view remains essentially reductionist and mechanistic.

C

understood. Visits to the oncologist are timed (Medicare payments are on a time

scale) and explanations in relation to treatments rarely involve giving full disclosure,

therefore not allowing true informed consent or informed choice by the patient.

T


250

eing

, whereas guidelines remain just that—a guide to doing what is allowed

nd expected, and often, in practice, what one can get away with.

M

ph

gif

em ir

incom

advocates for their patients.

The cancer patient, the end-user of oncology practice, is left reliant on the advice of

their doctor and on the regulation by government as to best clinical practices.

Unfortunately the end-user has little say as to treatments offered, and informed

choice for a patient does not fit with our current medical system.

Our Western culture’s view of death and dying encourages dramatic struggles to

prolong life, often with little consideration of the quality of life. Quality of life

issues should be an integral part of oncology.

The choice of whether to administer treatments with inherent risk to the patient,

compared to palliative pain control at the end stages of life, requires a deep

understanding of a patient’s beliefs, values, needs and wants, to ensure the best

possible treatment for a particular patient. Improving quality of life should be the

endpoint aim of palliative cancer therapy.71 Often quality of life is improved by

giving less aggressive treatment.72

There is, I feel, a great need for a paradigm shift in oncology. This would—as is the

nature of paradigm shifts—be exceedingly difficult in its implementation, but would

be extremely beneficial to the cancer patient. The profession of medicine has shown

itself to be highly protective of its status and of its monopoly on cancer treatments.

the morality of individual doctors. It is, however, an indication of a change in the

viewpoint of medicine. Oath taking highlights the serious nature of what is b

undertaken

a

onetary influences are evident not only in the funding of ethics centres by

armaceutical companies, but also in the belief of doctors that their acceptance of

ts from companies is not ethically wrong. Doctors are now partially in the

ployment of government, with Medicare repayments being a central part of the

e. They are therefore government employees, rather than being solely


251

Sadly, the philosophy of medicine, as taught and practiced in most countries, does

not appear to have had any great input into changes that have taken place in

oncology.

If the physician possesses gentleness of manners, and a compassionate heart, and what

Shakespeare called ‘the milk of human kindness’ the patient feels his approach like that

of a guardian angel administering to his relief: while every visit of a physician who is

unfeeling and rough in his manners, makes his heart sink within him, as at the presence of

one who comes to pronounce his doom. Men of the most compassionate tempers, by

being daily conversant with the scenes of distress, acquire in process of time that

composure and firmness of mind so necessary in the practice of physick.

John Gregory.73

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46 Moss RW (1995). Questioning Chemotherapy. New York, NY, Equinox Press.

47 McGrath P (1995). "Is there a better way? Bioethical reflections on palliative cytotoxic drug use."

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50 Frazer E, Hornsby J, et al. (1992). Ethics: A Feminist Reader. Oxford, UK, Blackwell Publishers.

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52 Washington S (2006). Planners order up an extra serving: Investors are being kept in the dark about

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(2006). "Poll Results." WebMD: Medscape Polls Retrieved November 2006, from

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55 Beasley JD and Swift JJ (1989). The Kellogg Report: The Impact of Nutrition, Environment &

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60 Berenson A (2005). Evidence in Vioxx Suits Shows Intervention by Merck Officials. New York

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New Science Library & Shambhala Publications.

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Payer L (1990). Medicine & C nd Sicknessulture. Notions of Health a . London, UK, Victor

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er KW (1987). "Palliative tumour chemotherapy and quality of life: what is op

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Changes in Cancer Research: Research Findings, Economics, Philosophy Jennie Burke – April 2007 Chapter 9 – Autopoietic Systems—A Biological Analogy

Chapter 9

Autopoietic Systems—A Biological Analogy

256

systems that are self-producing and self-constructing—one may draw comparisons

both medicine and the corporate world. The interaction

events

ed

not

ann defined autopoietic systems as systems that use their own output as input

2

ill allow

al events to ‘deform’ its autopoiesis. A ‘deformity’ may then induce some

3

ystem.

Th ords

au n.

To attempt a deeper understanding of ‘how’ and ‘why’ our system of medicine* has

brought us to our current situation, I have sought to use the concepts of Maturana and

Varela1 in their work on autopoietic theory.

Using the biological theory of Maturana and Varela on living systems—that is, on

with the social structure of

of these two differing types of structure may better elucidate the triggers and

that have led to our current system of oncology.

Autopoietic Systems

Living systems are open systems, whereby input from external sources is allow

and expected and causes a response. In closed systems, external influences are

possible. Autopoietic systems, however, have both open and closed qualities.

The Concept of Autopoiesis

Luhrm

and are (in this sense) their own product. Although an autopoietic system does not

allow external events to enter and disturb the entirety of the system, it w

extern

form of adaptation within the system. All operations of the system are self-

referenced and exist within the confines and boundaries of the s 4

e word autopoiesis has been formed through the conjunction of the Greek w

to, meaning self, and poiesis, meaning creation or productio

* For this section, I will use the term “medicine” to encompass the entirety of the social structure, i.e.

medicine, of which oncology is a sub-branch.


257

s that are self-producing or self-constructing—

.

In the 1990s, the sociologist Niklas Luhmann applied the concept to society, together

ystems theory.5 Luhmann also stressed the difference

nication. They relate to other

ocial sub-systems in the environment through this communication.6

n

h

change over time, the system

maintained in its totality rather than as a sum of the individual components.

non-

unther Teubner has been a proponent for the interpretation of the legal system as an

n which it is realized.

The concept of autopoiesis—system

was developed in the late 1970s by Maturana and Varela, both Chilean biologists,

who used the term to describe the nature of living, as opposed to non-living, entities

with action theory and social s

between psychical and social systems, with social systems operating on a foundation

of communication. Social systems evolve, maintain their specific identity and

reproduce themselves through their internal commu

s

Maintaining Autopoiesis

Maturana and Varela consider that autopoietic systems are defined by their

organisation. Once such a system has been attained, it recursively interacts withi

itself to maintain its structure.7

Maintaining the structure may be equated to maintaining power and control.

Whereas an open system must readily adapt to survive, an autopoietic system

maintains stability as an ongoing process, providing members of the system wit

their identity. Even though the members of the system

is

The structure of such a system must identify anything outside of itself as being

self, as established by the demarcation of boundaries of the structure.8

G

autopoietic entity. Whittaker (1995) states that this is seen as:

... the application of cybernetic principles to the ongoing debate among legal theorists

concerning the status of law as either (a) ‘autonomous’ and ‘self-referring’ or (b)

‘derivative’ of the sociocultural setting i 9


258

ral

s that produce the ‘events’ that change the communication boundaries of the

gal structure.

er

is modern law written in the Dickensian

.

y

ecific applications and meanings in the law, and

apply law to fact scenarios that have endless computations.

xpects to understand documentation and laws that affect our lives. This

dian and British

o produce a text in language that is not contemporary restricts public access; it

he legal profession has adapted and changed the boundaries of its system to ideally

Language As Communication

Law and government are intrinsically connected, however it is the social and cultu

setting

le

Plain English in Legal Texts

The legal system in Australia changed its language because of adverse publicity ov

many years and public distrust. No longer

language of the past. The use of Latin has ceased

The principle of the Rule of Law is based on the understanding that those affected b

a law must be able to ascertain its meaning and effect. This use of plain English has

not meant that lawyers are no longer required. Lawyers are needed to interpret law,

to understand and search for sp

to

Our society e

public need was recognised in 1983 when the Australian Government introduced

Plain English and Simpler Forms Programmes. The US, Cana

governments all now have plain language policies.10

T

produces and maintains a hierarchy with the public at the lowest level. This is

similar to the ancient guilds, where access to knowledge was restricted to only the

few.

T

allow access to all, at least in the area of terminology. Where law may have been a

self-contained, self-reproducing closed system, it has been forced to broaden its

language and therefore its boundaries.


259

be

by controlling the concepts of

n

ith medicine the concepts are not quite so clear cut. Medicine is not a system of

e

ring

ingers (2004)13 has outlined two definitive requirements for a system to be

ion of

components that themselves constitute the system.

Th ls at

un ed and

agreed-upon curricula. There is generally little variation in the teachings in medical

f students.

In contrast, medicine has yet to do this. The medical language still tends to

mysterious and unintelligible to those who have not studied medicine or a related

field.

The legal system has gained operational closure

legal/illegal and thus has retained exclusive control of the legal social structure.11

Laws, incorporating the concept of ‘legal/illegal’, are the basis of the constructio

and reproduction of their social system.12

Structure of the Medical System

W

disease/health: There are many stages in between the two. Cancer patients may b

healthy while still having a tumour, and may then become extremely unwell du

treatments to kill cancer cells.

M

autopoietic:

Ü Autopoiesis is concerned with the processes of production: the product

the

Ü An autopoietic organisation has clear demarcations or boundaries that are

constructed and maintained by the system.

e medical system is a total and complete structure, in which medical schoo

iversities begin the process by training young doctors in very well-establish

schools within a country.

Differences in cultural background cause variations in the forms and data used, but

generally medical doctors are easily recognisable as members of a global fraternity.

The new doctors may become researchers or clinicians or may, in turn, teach new

influxes o


The role of medical research is to improve treatments, develop new testing

procedures and improve medical techniques, all of which continue in the system as

tools of the system.

260

autopoietic system by its self-referencing and

sel

res

as

su

Th

pro

reproduce these events over and over again. aintains and directs the

activities and behaviour

Su alth

sy

M

nal closure does not imply interactive closure or isolation from the

nvironment. Clearly organisms do, necessarily, interact with their environment. The

,

sult of

Bo

Bo

ma rk within the medical social structure

and the structure acts as a totality rather than as a collection of individual members.

Th r

identity.

Maintaining Autopoiesis by Self-Production

Medicine has maintained itself as an

f-production. Medicine as a social system produces and provides treatment,

earch and more members: more medical practitioners. This means that medicine

a structure imports energy from the environment—bringing in people, government

pport, diverse resources and so on—then uses this energy to create a product.

e product is the training of new people, the scientific research, the treatments

vided, and the energy required to continually maintain the structure and to

The structure m

of its members.

ch a hierarchical structure allows the discourse of the powerful medical and he

stem to overrule the voice of the less powerful, the public.14 According to

ingers:

Organizatio

e

point is that such interactions also continue the ongoing process of autopoiesis; otherwise

they would not occur. They form part of a circular, self-sustaining process. The re

organizational closure is autonomy – the organization demarcates itself from its

environment and, through its own self-referential processes, maintains its self.15

undaries of the Medical System

rders and boundaries of the medical structure have been clearly delineated for

ny years. The members are trained and wo

is gives the structure stability and provides the individual members with thei


261

the

at

007 with a medical practitioner on

ntly,

medical school was quite a shock. I had expectations that this was a deeply intellectual

ny

aged

educated professionals adhere to the

dogma and continue often unsuccessful patterns of behaviour when there are many

e

ly time to have a stock

response.

ence and my ability to

memorise the long lists of information so I wouldn’t kill patients. However, there was a

thing went wrong I’d be abandoned by my

ssion and

m critiquing the profession or

The boundaries are established through the legal and government acts that define

permitted practitioners of medicine and through the psychological boundaries th

are imposed on the members themselves.

The following is taken from my discussions in 2

the inculcation of such boundaries.

I started medicine after an Arts degree, working and extensive travel. Conseque

and spiritual profession, as it needs to be. But, what I experienced was a rigid dogma and

closely controlled set of stereotypic practices. In fact, the medicine I was taught is

substantially pattern recognition where the patient’s symptoms are fitted into stock

responses of investigations and treatments. And, despite the good intentions of ma

doctors, patients aren’t usually cured of their illness. Rather, their symptoms are man

and a doctor documents their decline into worse health.

The 50 billion dollar question is why do these highly

successful alternative treatments described in the scientific literature? One reason is

Medicare and its support for brief consultations. Five to fifteen minutes isn’t enough tim

to do a thorough history, examination or treatment. It’s on

Another reason is pervasive fear. I began to experience in my first years of med school a

free-floating anxiety. In part, this was a fear around compet

second fear and this almost stopped me from practising altogether on a number of

occasions. This is the well-based fear that if I don’t follow the prescribed pattern of

investigations and treatments then if any

profession and medical insurance. And conversely, if I did follow them it’s unlikely

there’d be any adverse consequences for me.

The fear of medico-legal problems or investigation by the medical profe

government regulatory bodies effectively stops doctors fro

stepping outside its dogma and narrow practices. Little wonder doctors are so

conservative and protective of their own.16


262

d to conform and maintain

cture self-regulates, with the legal demarcation of its powers fixed

ment, each State enacting its own Medical Practice Act.17

,

any situations, are dealt with in Australia by the Medical Board or

e Health Care Complaints Commission. Serious complaints are dealt with by the

fine, suspend or deregister the practitioner. An appeal of a

Co

de

The regulatory capacity of this system replaces many of the normal legal situations

e strength and power of the medical

s two

-regulating professions.18

ce to society. Only people in the

particular profession can render the service, and the service rendered is

alised training.

4. Provides both individual members of the profession and the professional

group with a considerable degree of autonomy and decision-making authority.

The induction of such anxiety to remain within the safety of the system is a very

powerful boundary—it controls and enforces the nee

dogma. Unfortunately it also stifles innovation.

Self-Regulation Within the Medical Structure

The medical stru

by Acts of Parlia

Complaints about medical practitioners, such as unsatisfactory professional conduct

which can cover m

th

Medical Tribunal. The Commission and Tribunal have the power to caution,

reprimand, counsel,

mmittee’s decision is heard by the Tribunal, but an appeal of the Tribunal’s

cision must be taken to the Supreme Court.

for other members of our society, and shows th

system to control its own fate and that of its members.

The British Columbia College of Teachers has published a monograph,

Understanding Professional Self-Regulation in British Columbia, that provide

examples of definitions for self

The first example, from Ryan and Cooper’s book Those Who Can, Teach, 1988,

states that a self-regulating profession:

1. Renders a unique, definite and essential servi

considered so important that it is available to all people in a society.

2. Relies on intellectual skills in the performance of its service.

3. Has a long period of speci


263

ir activities rather than having outsiders set

f r policy in its ranks.

8. Has a code of ethics that sets out the acceptable standards of conduct for its

r, status and other benefits of

in exchange for which they agree to place the welfare of

Professional groups regulate the

policies and enforce adherence to standards.

5. Requires its members to accept personal responsibility for their actions and

decisions.

6. Emphasises the services rendered by its partners more than their financial

rewards.

7. Is self-governing and responsible o

members.

The second example, from Michael Doherty of the BC Public Interest Advocacy

Centre, states that:

(Professionals are) those who are willing to accept the honou

the designation (of professional)

those whom they serve foremost and to avoid any conflicting biases of confounding

relationships. (Emphasis added by the BC College of Teachers.)

Is Self-Regulation in Medicine Working?

There have been failures in medicine relating to both the above definitions.

ccording to Ryan and Cooper’s first point, medicine should provide an essential

certain

e profession may ‘expect’ that its members

for their personal actions, in many cases, where monetary

embers of the

me

offers and ‘gifts’ from

A

service that is available to all members of society. In sections of our society,

groups—because of poverty—are denied the same access to treatment that is

available to wealthier groups.

With respect to the fifth point, although th

will accept responsibility

gain has been involved, this has not been the case.

In this regard, the quote from Doherty is particularly applicable to m

dical profession, as a reminder of how to behave when confronted by monetary

industry.


264

ssion began with the institution of

un

surgeon-apothecaries as general practitioners. The Medical Reform Act of 1858 then

uncil that oversaw all medical practice in the UK, stipulating that only

Such decision m

ov l, economic and institutional areas of medical care. This control

has also extended to influencing the decisions made by associated entities, such as

ate health insurers, other health care practitioners and

by restraining the production and

dissemination of ‘other’ information.

edical profession in

Medicine was further criticized by the lack of openness and transparency in regulatory

History of Medicine as a Profession

The establishment of medicine as a profe

iversity medicine in the 1400s. A parliamentary act in 1815 in the UK recognised

created a co

universities and the established corporations of surgeons, apothecaries and

physicians could grant medical licences.19

aking has been strongly held by the profession, which has control

er most of the lega

hospitals, medical schools, priv

government agencies (as discussed in previous chapters).

Suppressing the Competition

The issue of the medical profession’s control of its own structure and its self-

replication—as in the certification of medical specialists—has potentially suppressed

the emergence of competing sources of information

This suppression has been possible through the assumption that the medical

profession knows best what society’s needs are and how they should be managed.20

This then leads into potential areas of legal wrong-doing, such as anti-trust laws in

the USA and anti-competition laws in Australia.

Abuse of Privilege

The latter part of the 20th century has witnessed abuse by the m

its privileged status and public trust, and in the flaws exposed in its regulatory

processes, as described by Cruess in 2005:

procedures and for the absence of public involvement in them. In short, the system

appeared to lack accountability.21


265

MJ) stated that the General

rial referred to an analysis of the situation by the last president of the GMC,

ir Donald Irvine, who critically stated that:

e

The Medical Tribunal is the body that deals

ith serious complaints; only when an appeal is made on a decision of the Medical

d.

y

ristol Royal Infirmary Paediatric Cardiac Surgery Inquiry,23

aediatric cardiac surgery scandal.24

Ü The Camden and Campbelltown hospitals (NSW), the Canberra Hospital

wers

stems from beliefs instilled in medical school.

A 2005 editorial in the British Medical Journal (B

Medical Council (GMC) of Britain has:

... broken its contract with the public—to protect patients in exchange for the privilege of

self regulation…22.

The edito

S

The culture is wrong. It is reactive rather than proactive, prefers that doctors should be

trusted rather than held accountable, places consensus before leadership, is driven by

expediency and compromise, and in the last analysis will put fairness to doctors ahead of

patient protection.

Dealing with Offenders

The self-regulating capacity of the medical profession is evident in the handling of

offences committed by a member of the medical profession. Most offences are dealt

with internally, rather than in other venues such as legal courts, as set out by th

Medical Practitioner Acts (State Acts).

w

Tribunal is the matter taken to the Supreme Court.

Negative Response to Whistleblowers

The effectiveness of the profession to self-regulate has been criticised, particularly

when external reviews of the adequacy of health care in hospitals have been initiate

Reviews initiated by whistleblowers—all of whom were treated poorly because the

sounded the alarm—were held at the following hospitals:

Ü The B

Ü The Winnipeg p

(ACT) and the King Edward Memorial Hospital (WA).25

The protective position of many in the medical profession toward whistleblo


Medical School Encouraging a Guild Mentality

266

-year

ns being made.

here was a 40% correct response at both beginning and end of four years of ethics

hat we can recognise here is a profession, and structure, that consciously and

needs

y

misconduct to flourish. This code exaggerated the need for and benefits of mutual

not be criticised by anyone

such

A 2003 study of medical students’ attitudes found that—when students were

challenged with identical ethical problems in their first and final weeks of a four

medical course—there was no increase in ethically correct decisio

T

training.

More disturbing, however, is that although only 13% of students at the beginning of

the course confirmed that they would report unethical behaviour, by the end of four

years of training this figure had dropped to less than 5%.26

W

habitually seeks to maintain a guild-style mentality, where devotion to and protection

of other guild members, and their shared organisation, takes precedent over the

of the patient. This establishes and maintains boundaries of the structure and

attempts to internalise any regulation.

There appears to have developed in medicine a culture of ‘us’ and ‘them’ that is ver

similar to the police culture exposed in Queensland by the Fitzgerald Inquiry of

1989. Fitzgerald found that there was an unwritten police code that allowed

loyalty and support. The code meant that police could

outside the police force and that “police [could] not enforce the law against other

police, nor co-operate in any attempt to do so, and perhaps even obstruct any

attempt.”27

Structural Coupling

‘Structural coupling’—in which social sub-systems are linked through the sharing of

selective communications—occurs when ‘deformities’ or ‘irritations’ from their

environment or from another social sub-system impinge upon the system.28


Structural Coupling with the Pharmaceutical Companies

Medicine has formed a permanent structural coupling with the pharmaceutical

companies. There is a common language that is shared, yet the aspirations and

central thrust of each of these structures is intrinsically different.

267

he social system of medicine has developed in response to the greater

e d, for

cause

cellular processes, all ultimately aimed towards

e benefit of the people within the greater social structure.

, to

t that

cal

Effects of Divergent Goals of Medicine and Pharma

stems are structurally coupled over a period of time, they

te,

ucturally coupled with

in goal, this variance created a ‘deformity’ or ‘irritation’

deep within the medical social system. The system then adapted to the deformity

T

environment’s need for health management. The ‘need’ is for people to b cure

help with pain management, for diagnosis and prevention of disease. The science of

medicine is engaged in research into these areas for a greater understanding of

and effect, for the understanding of

th

The ‘need’ or aim of a corporation, however, is not only the self-maintenance of the

corporation, but also for the production of the wealth of that corporation. This

production of wealth is of benefit to the ‘members’ of this social structure, that is

the owners (share-holders) and staff employed by the structure. The requiremen

profit is the end goal of the corporation places economic rationality in an inflated

position. The need for profit downgrades other concerns that are important for the

healthy functioning of a corporation, such as workers’ health and well-being, criti

participation by all members of the corporation, and care for the environment.29

When two autopoietic sy

affect one another’s structures and consequently also the behaviour they both

manifest.30

If medicine had developed into a discrete autopoietic system it could self-replica

self-maintain and self-regulate, because the goals for this system would be shared by

the entire system. However, when medicine became str

systems that have a variance

without changing its structure irrevocably. Thus the divergent goals caused

extensive changes in the system’s structure.


268

he coupling of medicine and commerce has progressed to a level where ‘medicine’

dical

ietic system reaches the stage where the benefit of internalising

ch

d

s a result of this changed situation, it seems likely that the benefits

society might be compromised. Whether this change will be beneficial for the

his comparison of the medical system as a living system enables us to view it as an

bout the sort of transformative

hange that would make an innovative structural shift.

s autopoietic nature. In biological systems, this can

e seen when cells and organisms become parasitised.

T

is dependent upon commerce for a large percentage of its funding. This funding

produces research and new products—products that should be solely in the domain

of the manufacturers. The funding is also needed to run and maintain the medical

system.

Without funding from industry, many medical schools could not survive.31 32.

Industry funding pays for many research projects;33 it pays for a large part of me

continuing education;34 35 and it rewards doctors for prescribing products that

increase profits for the companies.

When an autopo

change does not outweigh the detriment, it must either change or collapse. With the

declining government responsibility for the funding of medical schools and resear

centres, the medical system has chosen to change by seeking alternative funding

rather than collapse. The benefits to industry of this opportunity to increase its

influence and control are obvious—they can be seen within their ledgers in increase

profit margins. A

to

greater society and whether this change will continue to maintain the medical

structure is yet to be thoroughly examined and evaluated.

A Biological Analogy

T

autonomous entity. 36 Thus, as an autopoietic structure, the medical system has

established itself in our society with its own carefully set boundaries, as a self-

regulating and self-maintaining structure. Because of this, it will require major

deformations to its structures and processes to bring a

c

Parasitisation by Industry

The incorporation of industry, the pharmaceutical companies, into this self-

maintaining system is eroding it

b


269

commensals when the

lationship is symbiotic, when there is some mutual benefit to those involved.37

A host and parasite may co-evolve to maintain a relationship that does not kill the

host, as this would also be detrimental to the parasite. Generally, however, the

parasite causes harm to the host, even if the harm is subtle. The host and the parasite

may be forced over time to modify their behaviour to survive.

Conclusions

How long a parasitised structure (or cell) can survive is dependent on many factors.

In a social setting, the change induced in a structure by relinquishing much of its

autonomy to an external body may causes perturbations to the structure, and may

even change the structure’s intrinsic quality and nature. This would certainly appear

to be the case with the expanding intrusion of the pharmaceutical industry into the

medical system.

The basic nature of an industry or corporate structure is one of a commercial, money-

producing system. The ideal nature of the medical structure, however, is one where

the output—the research and practice of medicine—has as its goal the prevention and

treatment of disease for the benefit of the greater environment, the people.

As presented here, it is clear that the current medical system is increasingly a money-

making venture. The amount of money to be made in oncology is enormous.

Billions of dollars can be made from one ‘block-buster’ drug, for example, and

cancer patients may be prescribed many such drugs.

Money as a central theme may be the unfortunate end result for a system that has

changed its ‘intrinsic quality and nature’. This ongoing transformation of the

medical system has resulted from having its core co-opted by an external system that

has money-making as its goal.

The parasite derives benefits from its association with the host cell. Facultative

parasites can survive both in the host and as a free form. If they induce harm in the

host they are termed pathogenic. Parasites are referred to as

re


270

When two systems with divergent goals and different levels of power merge, it is

predicted that the more powerful will increasingly determine the nature of the less

powerful partner. Thus, in this case, the financial goal is overpowering the altruistic

goal of equitably serving the health needs of the population.

1 Maturana HR & Varela F (1980), Autopoiesis and Cognition: The Realization of the Living, Reidel,

Dordrecht, The Netherlands.

2 Luhmann N (1997), 'Globalization or World Society: How to Conceive of Modern Society?'

International Review of Sociology 7(1): 67-80.

3 Viskovatoff A (1999), 'Foundations of Niklas Luhmann's Theory of Social Systems', Philosophy of

the Social Sciences 29: 481-516.

4 Quick T (2006), 'Autopoiesis', Academic Resources, University College London, viewed March

2006, <http://www.cs.ucl.ac.uk/staff/t.quick/autopoiesis.html>.

5 Leydesdorff L (2000), 'Luhmann, Habermas, and the Theory of Communication', Systems Research

and Behavioral Science 17(3): 273-88.

6 Smith C (2004), 'Autopoietic Law and the 'Epistemic Trap': A Case Study of Adoption and Contact',

Journal of Law and Society 31(3): 318-44.

7 Viskovatoff A (1999), 'Foundations of Niklas Luhmann's Theory of Social Systems', Philosophy of

the Social Sciences 29: 481-516.



9 Whitaker R (1995), 'Autopoietic Theory and Social Systems: Theory and Practice', Association of

Computing Machinery - Special Interest Group, viewed March 2006,

<http://www.acm.org/sigs/sigois/auto/AT&Soc.html>.

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Government.

11 Neves M (2001), 'From the Autopoiesis to the Allopoiesis of Law', Journal of Law and Society

28(2): 242-64.

12 Smith C (2004), 'Autopoietic Law and the 'Epistemic Trap': A Case Study of Adoption and

Contact', Journal of Law and Society 31(3): 318-44.

13 Mingers J (2004), 'Can Social systems be Autopoietic? Bhaskar's and Giddens' Social Theories',

Journal for the Theory of Social Behaviour 34(4): 403-27.

14 McMillan JJ (1995), 'Organizational Codependency. The Creation and Maintenance of Closed

Systems', Management Communication Quarterly 9(1): 6-45.

15 Mingers J (1995), Self-Producing Systems. Implications and Applications of Autopoiesis, Plenum

Press, New York, NY, 206.


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16

Mathews M (2007), Dogma in Medicine, Sydney: Personal Communication, Jennie Burke, email 8

March.

17 (1992), 'Medical Practice Act 1992', Australasian Legal Information Institute (AustLII), viewed

2006, <http://www.austlii.edu.au/au/legis/nsw/consol_act/mpa1992128/>.

18 (2006), 'Understanding Professional Self-Regulation in British Columbia', British Columbia

College of Teachers, viewed 2006, <www.bcct.ca/documents/underst_self_regulation.pdf>.

19 Nutton V & Porter R (1996), Cambridge Illustrated History of Medicine, Cambridge University

Press, Cambridge, UK, p74 & p126.

20 Havighurst CC (1983), 'The doctors' trust: self-regulation and the law', Health Affairs 2(3): 64-76.

21 Cruess SR & Cruess RL (2005), 'The Medical Profession and Self-Regulation: A Current

Challenge', Ethics Journal of the American Medical Association 7(4).

22 Smith R (2005), 'The GMC: expediency before principle', British Medical Journal 330(1-2).

23 Bolsin SN (1998), 'Personal perspective. Professional misconduct: the Bristol case', The Medical

Journal of Australia 169: 369-72.

24 Sibbald B (1998), 'Twelve deaths in Winnipeg: judge must ponder 48,000 pages of testimony',

Canadian Medical Association Journal 59: 1285-87.

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Contact', Journal of Law and Society 31(3): 318-44.

29 McMillan JJ (1995), 'Organizational Codependency. The Creation and Maintenance of Closed

Systems', Management Communication Quarterly 9(1): 6-45.



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<http://www.iht.com/articles/2005/11/04/yourmoney/mbrf1.php>.

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1516-18.

33 Henry DA, Kerridge IH, Hill SR, McNeill PM, Doran E, Newby DA, Henderson KM, Maguire J,

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34

Wilson FS (2003), 'Continu oration Between Sponsor and

Industry', Clinical Orthopaedics 412: 33-37.

35

ing Medical Education: Ethical Collab

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sta.htm>.

Changes in Cancer Research: Research Findings, Economics, Philosophy Jennie Burke – April 2007 Conclusions

CONCLUSIONS

273

affected the field of oncology?

he

ents. Ideally these treatments should extend the

ost research needs to be occurring.

ve not substantially

declining use of

autopsy. Correct classification and routine autopsy would increase published

cancer death rates.

t receiving, the emphasis needed to

ic, nutritional medicine,

mistletoe therapy and ECT (electrochemical therapy)—have received little

What factors have shaped the theory and practice of oncology today? What factors

have led to today’s dominant forms of treatment? To what extent has it been the

result of research by well-intentioned investigators; to what extent has economics

influenced both the outcomes and the areas where money has been spent; and how

has the resultant medical philosophy

In an ideal situation, research findings should guide fields of enquiry that are

systematically explored, followed or rejected, and these findings should enable t

adoption of the best possible treatm

life expectancy of cancer patients, be humane and generally support good health.

However, because the ultimate form of cancer treatment is prevention, this is

logically where m

My study has, I believe, clearly shown that cancer research—in the past and

present—is far from the ideal scenario. The following research findings support this

conclusion. Supporting references are provided throughout the thesis.

Indicative Research Findings

Ü Long-term survival rates for the most common cancers ha

improved over the last century. In fact, mortality rates in the USA increased

between 1970 and 1994 by 6.0%.

Ü The incidence of cancers in the world is increasing. Cancer statistics do not

reflect the common misclassification of cancer deaths and the

Ü Prevention has not received, and is no

address this increase. Furthermore, prevention is commonly confused with

early detection.

Ü Potential ‘alternative’ cancer treatments—such as herbal remedies,

Traditional Chinese Medicine (TCM), Ayurved


274

’

and,

e over

ey have not been examined in clinical trials

nt

dequately used by conventional

and, have improved

other

resulted in just 2.3%

of patients benefiting in Australia and 2.1% in the USA.

in the common cancers, the presence of

ect

act

altruistically with respect to patient wellbeing.

serious study by the conventional medical establishment. Their ‘alternative

label has generally been used to relegate them to the fringes of science

largely because of this, they have been ignored.

Ü Modern day conventional treatments have shown no statistical advantag

the use of Coley’s toxins. Other similar treatments—employing bacterial

isolates by scientists such as Glover, Livingston-Wheeler and others—have

shown encouraging results, but th

for efficacy.

Ü Micronutrient use in combination with radiation therapy, and hyperthermia in

conjunction with chemotherapy, may both have potential in future treatme

protocols, yet these approaches are still largely being ignored in current

treatment procedures.

Ü Research into the diverse causes of cancer—such as bacterial induction—has

been largely neglected and has not been a

oncology.

Ü Surgical techniques and radiation therapy, on the other h

over the last century. However, over the last 60 years the focus has centred

on chemotoxic drugs and, more recently, on monoclonal antibodies and

biological agents—even though 5-year survival studies with the most

common cancers, being treated only with chemotherapy,

Ü Recent research has indicated that,

cancer stem cells may provide one explanation for the poor response to

chemotherapy regimes. Will these new findings provide enough stimuli to

induce a paradigm shift in the way most cancers are treated?

Indicative Economics Observations

Ü It must be understood and acknowledged that industry (Pharma) has as its

primary goal the production of profit for shareholders. It is naïve to exp

that this industry’s main aims are to service the community and


275

to be more likely to

h papers has created problems for journals and raised issues as to

tends to the funding of continuing medical

ind journal reviewers who do not have a conflict of

Ü

Ü ave developed between Pharma and government bodies at state,

nd international levels. The movement of personnel between

rnment in

ent of the

seriousness or, indeed, any ‘spiritual’ side of medicine becomes a reflection of

Ü When trials are funded by Pharma, research findings may be suppressed or

delayed if results are counter to these economic priorities of industry.

Pharma-funded trials with their products have been found

show a positive outcome than independent trials on the same products.

Ü The common practice of Pharma hiring professional science writers to ghost

write researc

the validity of published studies.

Ü Pharma funds many universities and corporate ties are held by significant

numbers of academics—many of whom become shareholders—raising issues

of conflict of interest. This ex

education and bioethics centres. This affects the medical system at its core.

Ü Pharma funds advertising in medical journals. Indeed, it is becoming

increasingly difficult to f

interest because of industry connections.

Pharma regularly gives ‘gifts’ to doctors to encourage the use of their

products. This does not support ‘best medical practice’.

Strong links h

national a

Pharma and regulatory bodies, in particular, links industry and gove

ways that may encourage bias and minimise constraint.

Indicative Philosophy Observations

Ü Ethics is a sub-set of philosophy, not a philosophy in itself. The medical

structure has tended to substitute ethics for a ‘philosophy of medicine’. There

has been a de-emphasis on the use of oaths as an enforcement of the bond and

contract between doctor and patient. This failure to take an oath shows that

the medical mindset is, at least to some extent, on other things. The oath is a

‘spiritual’ binding or a binding by sanctions. Lack of enforcem

Pharma being just a business. This does not support and encourage the

concept of medical doctors being ‘in the service of humanity’.


276

current system. Significant

beneficial change would require a major paradigm shift.

a

holistic needs. All Medicare

payments are ‘time-scaled’.

negative consequences.

he theory and practice of oncology. Indeed, they

re amongst the most influential and wealthiest of all industries.

do their

en our ‘health services’ and systems were first

Ü Our medical system is limited by ‘received beliefs’—dogmas—making most

innovation difficult to accomplish within our

Ü Although current ethics guidelines may stop some unwarranted treatment,

they do not necessarily promote a genuine informed ‘choice’ among therapies

for patients.

Ü Inadequate time allotment for consultations (merely sufficient to prescribe

curative drug rather than investigate and address the causes) do not allow for

deep understanding of a patient’s long-term and

Ü Many of the treatments that are commonly given lower the quality of life of

cancer sufferers and some may induce further tumours and result in other

Ü Interestingly, a study by Abel (see Chapter 3, History of Cancer Research:

Cause and Treatment, page 59) indicated that some oncologists stated that

they would refuse chemotoxic treatments if they themselves were diagnosed

with cancer.

In Conclusion

There is no disputing the wealth, political influence and power of today’s

pharmaceutical companies over t

a

We should have no expectation that the pharmaceutical companies will not

utmost to make large profits. However, we should expect them, if only because of

regulations, to pursue profits legally and ethically. The many cases of corporate

malfeasance in Pharma would indicate that the drive for profit commonly

compromises ethics. It is naïve for those in the medical system not to realise that

industry has any greater motive other than the making of money.

There is now no area of medicine that Pharma has not infiltrated. The medical

structure may have been able to resist this push from industry if there had been a

strong enough philosophical base wh


277

he

topoiesis and structural coupling provide a framework for further

search into the increasing integration of medicine and industry. Both oncology and

ny

ese

he structural and procedural coupling of oncology and the pharmaceutical industry

has produced a parasitised structure that has two very divergent goals.

Patients naively rely on a system in which their welfare, health and survival is the

ultimate goal. Monetary, profit-making goals have been shown to be detrimental to

this patient goal. When industry-funded trials give a higher percentage of positive

outcome than independent trials, because of manipulation of the results, then the

patient receiving therapy based on industry-funded research may be at risk. At the

very least, the suppression of research that questions the dogma of the day has cost

us many decades in which potential treatments and identification of causes could

have been thoroughly explored.

My research has focused on systems and structures, with individual cases being

provided as examples of pathology within the larger system of science and

oncology/medicine. For those medical practitioners who read this, I would like to

stress that the problems appearing in the basic functions of oncology are largely

systems problems and not ‘failures of physicians’. I am not inferring that oncologists

lack compassion and care but rather that they are operating within a system in which

their choice of treatments are limited and, as a result, are not generally successful. I

believe that most young doctors commencing their oncology specialisation do so

with a genuine desire to palliate suffering and to cure cancer. Unfortunately the

system does not adequately support this desire and does not enable doctors to put

their patients’ needs above all else.

established. However, once the core of the medical structure had been infiltrated, t

entire structure became increasingly compromised.

The concepts of au

re

the medical system have boundaries that are maintained to exclude and constrain a

threats to the status quo or progressions from it. Medicine has put in place th

boundaries—legal boundaries via legislation as well as psychological boundaries—

to constrain and maintain unquestioning compliance.

T


278

The purpose of this research was not to provide a detailed or definitive analysis of

cancer research, treatment and ph as designed to offer an

overview of these areas using individual cases to illuminate problems within the

basis fo ding of these connections. A deeper

r

theory

ilosophy. Rather it w

dominant system.

The biological analogy of autopoietic systems and structural coupling provides a

r further analysis and understan

understanding of these issues will, I believe, allow for progressive change to occur

and for research findings to become the true arbiter of directional change in cance

and practice.

Changes in Cancer Research: Research Findings, Economics, Philosophy Jennie Burke – April 2007 References

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304

APPENDIXES

Changes in Cancer Research: Research Findings, Economics, Philosophy Jennie Burke – April 2007 Appendix 1 – World Medical Association: Declaration of Helsinki

Appendix 1

305

Ethical

Aam29th W35th W41st W48th W a, October 1996 and the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000

mbly,

N o2

A. INT

1. ysicians and

identifiable data.

3.

4. n

5. tions related to the well-

6. ving human subjects is to

y

World Medical Association: Declaration of Helsinki

Principles for Medical Research Involving Human Subjects

dopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and ended by the

MA General Assembly, Tokyo, Japan, October 1975 MA General Assembly, Venice, Italy, October 1983 MA General Assembly, Hong Kong, September 1989 MA General Assembly, Somerset West, Republic of South Afric

Note of Clarification on Paragraph 29 added by the WMA General AsseWashington 2002

ote f Clarification on Paragraph 30 added by the WMA General Assembly, Tokyo 004

RODUCTION

The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to phother participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or

2. It is the duty of the physician to promote and safeguard the health of thepeople. The physician's knowledge and conscience are dedicated to the fulfilment of this duty.

The Declaration of Geneva of the World Medical Association binds the physician with the words, "The health of my patient will be my first consideration," and the International Code of Medical Ethics declares that, "A physician shall act only in the patient's interest when providing medicalcare which might have the effect of weakening the physical and mental condition of the patient."

Medical progress is based on research which ultimately must rest in part oexperimentation involving human subjects.

In medical research on human subjects, considerabeing of the human subject should take precedence over the interests ofscience and society.

The primary purpose of medical research involimprove prophylactic, diagnostic and therapeutic procedures and the understanding of the aetiology and pathogenesis of disease. Even the bestproven prophylactic, diagnostic, and therapeutic methods must continuouslbe challenged through research for their effectiveness, efficiency, accessibility and quality.


306

ic,

8.

rticular needs of the

e for

quirement should be allowed to reduce or eliminate any of the

B. BA ALL MEDICAL RESEARCH

1. uty of the physician in medical research to protect the life, health,

2.

opriate, animal experimentation.

4.

ce,

be in in which the

r

on

erest and incentives for subjects.

e with

6.

on and never rest on the subject of the research, even though the subject has given consent.

7. In current medical practice and in medical research, most prophylactdiagnostic and therapeutic procedures involve risks and burdens.

Medical research is subject to ethical standards that promote respect for all human beings and protect their health and rights. Some research populations are vulnerable and need special protection. The paeconomically and medically disadvantaged must be recognized. Special attention is also required for those who cannot give or refuse consent for themselves, for those who may be subject to giving consent under duress, for those who will not benefit personally from the research and for thoswhom the research is combined with care.

9. Research Investigators should be aware of the ethical, legal and regulatory requirements for research on human subjects in their own countries as well as applicable international requirements. No national ethical, legal or regulatory reprotections for human subjects set forth in this Declaration.

SIC PRINCIPLES FOR

It is the dprivacy, and dignity of the human subject.

Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and on adequate laboratory and, where appr

3. Appropriate caution must be exercised in the conduct of research which mayaffect the environment, and the welfare of animals used for research must be respected.

The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol. This protocol should be submitted for consideration, comment, guidanand where appropriate, approval to a specially appointed ethical review committee, which must be independent of the investigator, the sponsor or any other kind of undue influence. This independent committee shouldconformity with the laws and regulations of the countryresearch experiment is performed. The committee has the right to monitoongoing trials. The researcher has the obligation to provide monitoring information to the committee, especially any serious adverse events. The researcher should also submit to the committee, for review, informatiregarding funding, sponsors, institutional affiliations, other potential conflicts of int

5. The research protocol should always contain a statement of the ethical considerations involved and should indicate that there is compliancthe principles enunciated in this Declaration.

Medical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinicallycompetent medical person. The responsibility for the human subject must always rest with a medically qualified pers


307

participation of healthy volunteers in medical research. The

8. olving n

9. e e

re healthy

10. e

11.

12. ust always be respected. Every precaution should be taken to respect the privacy of the

e subject's physical and mental integrity and on the

f

r n

onsent cannot be obtained in writing, the non-written

14. ian is in a dependent relationship

7. Every medical research project involving human subjects should be preceded by careful assessment of predictable risks and burdens in comparison with foreseeable benefits to the subject or to others. This does not preclude the design of all studies should be publicly available.

Physicians should abstain from engaging in research projects invhuman subjects unless they are confident that the risks involved have beeadequately assessed and can be satisfactorily managed. Physicians should cease any investigation if the risks are found to outweigh the potential benefits or if there is conclusive proof of positive and beneficial results.

Medical research involving human subjects should only be conducted if thimportance of the objective outweighs the inherent risks and burdens to thsubject. This is especially important when the human subjects avolunteers.

Medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from thresults of the research.

The subjects must be volunteers and informed participants in the research project.

The right of research subjects to safeguard their integrity m

subject, the confidentiality of the patient's information and to minimize the impact of the study on thpersonality of the subject.

13. In any research on human beings, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts ointerest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail. The subject should be informed of the right to abstain from participation in the study oto withdraw consent to participate at any time without reprisal. Afterensuring that the subject has understood the information, the physiciashould then obtain the subject's freely-given informed consent, preferably in writing. If the cconsent must be formally documented and witnessed.

When obtaining informed consent for the research project the physicshould be particularly cautious if the subject with the physician or may consent under duress. In that case the informed consent should be obtained by a well-informed physician who is not engaged in the investigation and who is completely independent of this relationship.

15. For a research subject who is legally incompetent, physically or mentally incapable of giving consent or is a legally incompetent minor, the investigator must obtain informed consent from the legally authorized representative in accordance with applicable law. These groups should not be included in research unless the research is necessary to promote the health of the population represented and this research cannot instead be performed on legally competent persons.


308

to give assent to decisions about participation in research, the investigator

In publication of the

nding, institutional affiliations

1. The physician may combine medical research with medical care, only to the

re,

not exclude the use of placebo, or no atment, in studies where no proven prophylactic, diagnostic or therapeutic thod exists.

3. At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study.

4. The physician should fully inform the patient which aspects of the care are related to the research. The refusal of a patient to participate in a study must never interfere with the patient-physician relationship.

5. In the treatment of a patient, where proven prophylactic, diagnostic and therapeutic methods do not exist or have been ineffective, the physician, with informed consent from the patient, must be free to use unproven or new prophylactic, diagnostic and therapeutic measures, if in the physician's judgement it offers hope of saving life, re-establishing health or alleviating suffering. Where possible, these measures should be made the object of research, designed to evaluate their safety and efficacy. In all cases, new information should be recorded and, where appropriate, published. The other relevant guidelines of this Declaration should be followed.

16. When a subject deemed legally incompetent, such as a minor child, is able

must obtain that assent in addition to the consent of the legally authorized representative.

17. Research on individuals from whom it is not possible to obtain consent, including proxy or advance consent, should be done only if the physical/mental condition that prevents obtaining informed consent is a necessary characteristic of the research population. The specific reasons for involving research subjects with a condition that renders them unable to give informed consent should be stated in the experimental protocol for consideration and approval of the review committee. The protocol should state that consent to remain in the research should be obtained as soon as possible from the individual or a legally authorized surrogate.

18. Both authors and publishers have ethical obligations.results of research, the investigators are obliged to preserve the accuracy of the results. Negative as well as positive results should be published or otherwise publicly available. Sources of fuand any possible conflicts of interest should be declared in the publication. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication.

C. ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED

WITH MEDICAL CARE

extent that the research is justified by its potential prophylactic, diagnostic or therapeutic value. When medical research is combined with medical caadditional standards apply to protect the patients who are research subjects.

2. The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This doestreme


309

Note: Note of clarification on paragraph 29 of the WMA Declaration of Helsinki

The WMA hereby reaffirm aking use of a pla should only be used in the absence of existing proven therapy. However, a placebo-controlled trial may be ethically acceptable, even if proven therapy is available, under the following

se

A he n N i

g

a other

t s d

T olicy document of the as

f( 0 (Edinburgh, Scotland). Note of clarification on Paragraph 29 added by the WMA

9

s its position that extreme care must be taken in mcebo-controlled trial and that in general this methodology

circumstances:

Ü Where for compelling and scientifically sound methodological reasons its uis necessary to determine the efficacy or safety of a prophylactic, diagnostic or therapeutic method; or

Ü Where a prophylactic, diagnostic or therapeutic method is being investigated for a minor condition and the patients who receive placebo will not be subject to any additional risk of serious or irreversible harm.

ll other provisions of the Declaration of Helsinki must be adhered to, especially teed for appropriate ethical and scientific review.

ote: Note of clarification on paragraph 30 of the WMA Declaration of HelsinkThe WMA hereby reaffirms its position that it is necessary during the study planninprocess to identify post-trial access by study participants to prophylactic, diagnosticnd therapeutic procedures identified as beneficial in the study or access to

appropriate care. Post-trial access arrangements or other care must be described in he study protocol so the ethical review committee may consider such arrangementuring its review.

he Declaration of Helsinki (Document 17.C) is an official p

World Medical Association, the global representative body for physicians. It wirst adopted in 1964 (Helsinki, Finland) and revised in 1975 (Tokyo, Japan), 1983 Venice, Italy), 1989 (Hong Kong), 1996 (Somerset-West, South Africa) and 200

General Assembly, Washington 2002. .10.2004

Changes in Cancer Research: Research Findings, Economics, Philosophy Jennie Burke – April 2007 Appendix 2 – Hippocratic Oath—Classical Version

Appendix 2

Hippocratic Oath—Classical Version

310

ses, making them my witnesses, that I will fulfil according to my bility and judgment this oath and this covenant:

to live a

ut fee ll the

e and

injustice.

aw

female and male persons, be they free or slaves.

outside of the treatment in regard to the life of men, which on no account one must spread abroad, I will keep to myself, holding such things shameful to be spoken

Ü If I fulfil this oath and do not violate it, may it be granted to me to enjoy life and art, being honored with fame among all men for all time to come; if I transgress it and swear falsely, may the opposite of all this be my lot.

(Translation from the Greek by Ludwig Edelstein. From The Hippocratic Oath: Text, Translation, and Interpretation, by Ludwig Edelstein. Baltimore: Johns Hopkins Press, 1943.)

I swear by Apollo Physician and Asclepius and Hygieia and Panaceia and all the gods and goddesa

Ü To hold him who has taught me this art as equal to my parents and my life in partnership with him, and if he is in need of money to give himshare of mine, and to regard his offspring as equal to my brothers in malelineage and to teach them this art - if they desire to learn it - withoand covenant; to give a share of precepts and oral instruction and aother learning to my sons and to the sons of him who has instructed mto pupils who have signed the covenant and have taken an oath according to the medical law, but no one else.

Ü I will apply dietetic measures for the benefit of the sick according to myability and judgment; I will keep them from harm and

I will neither give a deadly drug to anybody who askedÜ for it, nor will I make a suggestion to this effect. Similarly I will not give to a woman an abortive remedy. In purity and holiness I will guard my life and my art.

Ü I will not use the knife, not even on sufferers from stone, but will withdrin favor of such men as are engaged in this work.

Whatever houses I may visit, I will come for the benefit Ü of the sick, remaining free of all intentional injustice, of all mischief and in particular of sexual relations with both

Ü What I may see or hear in the course of the treatment or even

about.

Changes in Cancer Research: Research Findings, Economics, Philosophy Jennie Burke – April 2007 Appendix 3 – Pledge—World Medical Association

Appendix 3

Pledge—World Medical Association

311

F THE MEDICAL ROFESSION:

Y LIFE TO THE

Ü I WILL GIVE to my teachers the respect and gratitude that is their due;

confided in me, even after the

noble traditions of the medical profession;

Ü MY COLLEAGUES will be my sisters and brothers;

iliation, race, sexual orientation, social standing or any other factor to intervene between my

Ü I WILL NOT USE my medical knowledge to violate human rights and civil liberties, even under threat;

I MAKE THESE PROMISES solemnly, freely and upon my honour.

http://www.wma.net/e/policy/c8.htm.

AT THE TIME OF BEING ADMITTED AS A MEMBER OP

Ü I SOLEMNLY PLEDGE TO CONSECRATE MSERVICE OF HUMANITY

Ü I WILL PRACTISE my profession with conscience and dignity;

Ü THE HEALTH OF MY PATIENT will be my first consideration;

Ü I WILL RESPECT the secrets that are patient has died;

Ü I WILL MAINTAIN by all the means in my power, the honour and the

Ü I WILL NOT PERMIT considerations of age, disease or disability, creed, ethnic origin, gender, nationality, political aff

duty and my patient,

Ü I WILL MAINTAIN the utmost respect for human life;

Changes in Cancer Research: Research Findings, Economics, Philosophy Jennie Burke – April 2007 Appendix 4 – Hippocratic Oath—Johns Hopkins University

Appendix 4

312

Hippocratic Oath—Johns Hopkins University

which I hold most sacred ...

hat I will be fully committed to those I serve ... and just and loyal to the profession ers ...

hat into whatsoever house I shall enter ... it shall be for the good of the sick ... to the aloof from wrong ... from corruption ... and

y art ... solely for the care of my patients ... and will give no ration ... without justifiable purpose ... far less suggest it

.

l see or hear ... of the lives of men and women ... which is not I will keep inviolably secret ...

gs I do promise ... and in proportion as I am faithful to this my oath ... may appiness and good repute be ever mine ... the opposite if I shall be forsworn.

I do solemnly swear ... by that Tof medicine and its memb That I will lead my life ... and practice my art ... in uprightness and honor ... Tutmost of my power ... holding myself from the tempting of others to vice ... That I will exercise mdrug ... and perform no ope.. That whatsoever I shalfitting to be spoken ... These thinh

Changes in Cancer Research: Research Findings, Economics, Philosophy Jennie Burke – April 2007 Appendix 5 – GEMZAR Phase III Trial

313

Appendix 5

ZAR for Ovarian Cancer

e

6)

te

GEMZAR Phase III Trial

For Oncology Professionals Clinical Data: GEM Pivotal Phase III Trial GEMZAR was studied in a randomized phase III study of 356 patients with platinum-sensitive1 advanced ovarian cancer. Patients were randomized to receiveither GEMZAR plus carboplatin or single-agent carboplatin as the control arm. Randomization Schema and Dosing Pivotal trial design: Randomized phase III study (N=35 Primary Endpoint Progression-free Survival Secondary Endpoints Overall response raDuration of response Overall survival Toxicity GEMZAR Plus Carboplatin Versus Carboplatin in Ovarian Cancer Baseline demographics and clinical characteristics

GEMZAR/carboplatin Carboplatin

Number of randomized patients 178 178

Median age, years 59 58

Range 36 to 78 21 to 81

Baseline ECOG performance status 0-12

94% 95%

Disease status

Evaluable 7.9% 2.8%

Bidimensionally measurable 91.6% 95.5%

Platinum-free interval 3

6-12 months 39.9% 39.9%

>12 months 59.0% 59.6%

First-line therapy

Platinum-taxane combination 70.2% 71.3%

1 Platinum-sensitive patients are defined as those who develop disease progression at least 6 months after completion of

GEMZAR plus carboplatin arm and 4 on the carboplatin arm) did not have baseline Eastern

s recorded.

f

a platinum-based chemotherapy regimen.

2 Nine patients, (5 on the

Cooperative Oncology Group (ECOG) performance statu

3 Three patients (2 on the GEMZAR plus carboplatin arm and one on the carboplatin arm)had a platinum-free interval o

less than 6 months.


314

Platinum-nontaxane combination 5% 28.7% 27.

Platinum monotherapy .11.1% 1 %

In the GEMZAR plus carboplatin arm, dose reductions occurred with 10.4% of GEMZA 1.8% arbo tin injections vs 3.8% on the carboplatin arm. 13. AR doses re om ed an .2% arbo tin d es were omitted the carboplatin doses on the carboplatin arm here were no differ tinuatio ue to verse vents twee ms (10.9% vs 9.8%, re Superior Progression-Free Survival GEMZA oplatin offers su ior pr ression-free survival (PFS) and superior response rates over carboplatin alone, providing better disease control4 with a generally manageable toxicity profile. The addition of GEMZAR to carboplatin resulted ignific imp emen n PF early months), overall response rate, and complete resp se rat hen mpared to carboplatin alone.

.90])

bination with carboplatin offered 49% improvement in PFS vs. arboplatin alone.

verall Response Rate5

esponse Rate6 he combination of GEMZAR/carboplatin doubled the complete response rate when

.3 months) was not significant (p=0.8977).

enerally Manageable Toxicities he combination of GEMZAR and carboplatin is an effective regimen for the 2nd-ne treatment7 of platinum-sensitive advanced ovarian cancer with generally anageable toxicities.

Adverse Events from Comparative Trial of GEMZAR Plus Carboplatin Versus Single-Agent Carboplatin in Ovarian Cancer8 CTC Grades (% incidence)

R injections aZ

nd of c p al7% of GEM we itt d 0 of c pla oscompared to 0% of . Tences in discon ns d ad e be n arspectively).

R/carb per og

in a statistically s ant rov t i S (n 3on e w co

Kaplan-Meier Curve of Progression-Free Survival Hazard ratio = 0.72 (95% CI [0.57, 0 Progression-Free Survival GEMZAR in comc OThere was a 53% improvement in overall response rate. Complete RTcompared to carboplatin alone. Overall survival difference between GEMZAR/carboplatin (18.0 months) vscarboplatin (17 GTlim

as the combination of response rate and progression-free survival outcome.

Company. ONC20060627.

.

ria (CTC) Version 2.0 (all grades ≥10%).

4 Disease control is defined

5 Investigator-reviewed.

6 Data on File, Eli Lilly and

7 Second-line treatment is defined as treatment given to a patient who has not yet been treated for her first recurrence

8 Grade based on Common Toxicity Crite


315

GEMZAR plus carboplatin

N=175 Carboplatin

N=174

All

Grades Grade

3 Grade

4 All

Grades Grade

3 Grade

4 Laboratory F

9F

Hematologic Anemia 86 22 6 75 9 2 RBC transfusionF

10F 38 15

Neutropenia 90 42 29 58 11 1 Febrile neutropeniaF

11F 1.1 0

Leukopenia 86 48 5 70 6 <1 Thrombocytopenia 78 30 5 57 10 1 Platelet transfusionF

12F 9 3

Non-laboratory F

13F

Alopecia 49 0 0 18 0 0 Neuropathy-sensory 30 1 0 27 2 0 Nausea 69 6 0 61 3 0 Fatigue 40 3 <1 32 5 0 Vomiting 46 6 0 36 2 <1 Diarrhea 25 3 0 14 <1 0 Anorexia 16 1 0 13 0 0 Stomatitis/pharyngitis 22 <1 0 13 0 0 Constipation 42 6 1 37 3 0

There were no differences in discontinuations due to adverse events between arms (10.9% versus 9.8%, respectively). G-CSF was not used prophylactically in this trial. Actual use: 23.6% and 10.1%, respectively. Myelosuppression is usually the dose-limiting toxicity with GEMZAR therapy. See the complete Warnings, Precautions, Adverse Reactions, and Dosage and Administration sections in the full HPrescribing InformationH for safety and dosing guidelines. Copyright © 2006 Eli Lilly and Company. All rights reserved. This site is intended for use by United States residents only. For more information about cancer, contact your doctor or other healthcare professional. MG28487

9 Percent of patients receiving transfusions. Transfusions are CTC-graded events. Blood transfusion included both

packed red blood cells and whole blood.

10 Regardless of causality.

11 Grade based on Common Toxicity Criteria (CTC) Version 2.0 (all grades >1% and ≤10%).

12 Regardless of causality.

13 Percent of patients receiving transfusions. Transfusions are CTC-graded events. Blood transfusion included both

packed red blood cells and whole blood.