“T AKE TWO OF THESE AND CALL ME IN THE MORNING · “T AKE TWO OF THESE AND CALL ME IN THE MORNING ” ... inflation rate was 0.6% increase from the previous year and ... conscience

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ARIZONA SUMMIT LAW SCHOOL – LAW REVIEW

ADVANCED WRITING REQUIREMENT

A NEW FUNDAMENTAL RIGHT

“TAKE TWO OF THESE AND CALL ME IN THE MORNING”

A MEDICAL PATIENT’S RIGHT TO CHOOSE A TREATMENT MODE: TRADITIONAL

(ALLOPATHIC), INTEGRATIVE, OR ALTERNATIVE METHODS.

BY: THOMAS J. CHLEBANOWSKI

JUNE 28, 2015

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A NEW FUNDAMENTAL RIGHT

“TAKE TWO OF THESE AND CALL ME IN THE MORNING”

A MEDICAL PATIENT’S RIGHT TO CHOOSE A TREATMENT MODE: TRADITIONAL

(ALLOPATHIC), INTEGRATIVE, OR ALTERNATIVE METHODS.

BY: THOMAS J. CHLEBANOWSKI1

I. INTRODUCTION

Since the days of Greek medicine under Hippocrates, physicians, or men of

medicine, commonly pledged a “Hippocratic Oath.”2 As a central tenet of the early practice

of medicine, doctors promised (in an implied way) to first do no harm and let food be thy

medicine and medicine be thy food, in treating patients.3 Today, in the global practice of

modern medicine, more generalized principles of medical professional ethics replaced the

original Hippocratic Oath, where medical physicians put a patient’s interests first, ahead of

the physician.4 Today, what has been referred to as western science-based medicine has

distorted into a one-sided, myopic physician’s view of patients’ best interest, where the

1 Mr. Chlebanowski (Kleb-a-now-ski) is a third-year Law Student at Arizona Summit Law School (Anticipated graduation date: December 2015). Mr. Chlebanowski has been dedicated to the use, and sought treatment from the alternative medicine arena for over thirty-years, when he attended his first Chiropractic appointment in Illinois. I would like to thank Dr. Bruce Shelton, M.D., M.D.(H) DiHom FBIH., as my personal Homeopathic and Integrative Physician for his knowledge and inspiration. Additionally, I would like to thank Mr. Sherman Cohn, Professor of Law at Georgetown University, who specializes in Complementary and Alternative Medicine Law, for his honorable review and feedback of my draft outlines, and providing his invaluable guidance, legal wisdom, and opinion. Thank you to anyone else who I may have missed, who has contributed to this effort. I would also like to thank my family for the love and support they have offered me through my 18 year desire to attend law school. Finally, I would like to dedicate this article to my recently departed brother Matt, who, although he left this planet early, I know we will meet again someday. 2 Greek Medicine, NAT’L LIBRARY OF MEDICINE, NAT’L INST. OF HEALTH, http://www.nlm.nih.gov/hmd/greek/greek_oath.html (last visited June 15, 2015). 3 Id. 4 World Medical Ass’n (WMA), INT’L CODE OF MEDICAL ETHICS. http://www.wma.net/en/30publications/10policies/c8/index.html (last visited June 15, 2015)

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patient essentially has a limited right to, or is unaware of, a full spectrum of medical

treatment.

For example, in 2010, a dairy farmer from Auckland, New Zealand, Mr. Alan Smith,

at the brink of death, in a hospital intensive care unit, on life support in a medically induced

coma.5 Alan was suffering from the fatal H1N1 Virus (aka: “Swine Flu”) that he contracted

while on vacation.6 Alan’s medical prognosis was grim; his chest x-rays showed complete

infectious fluid build-up within his lungs and he had no air exchange or functionality in his

lungs.7 Just days before, a medical panel of experts – including one expert from the United

States – agreed that Alan would not survive and they agreed to remove him from life

support.8 Alan’s family insisted that the hospital administer high doses of intravenous

Vitamin C to Alan.9 The hospital agreed and within 48 hours, his lungs began to clear,

miraculously gaining about 30 percent usage of his lungs.10 The following day, the medical

panel took Alan off the Vitamin C administration and his condition dramatically declined

to near mortal levels.11 Most notably, the doctors subsequently refused to re-administer

Vitamin C again to Alan.12 This time his family retained legal counsel to force the doctors

and the hospital to begin re-administering Vitamin C to Alan.13 The hospital relented and

5 60 Minutes, New Zealand: Vitamin C, The Miracle Swine Flu Cure (60 Minutes) "Living Proof" (New Zealand broadcast published August 12, 2012) https://www.youtube.com/watch?v=VrhkoFcOMII (last visited June 15, 2015). 6 Id. 7 Id. 8 Id. 9 Id. 10 Id. 11 Id. 12 Id. 13 Id.

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began giving Alan a significantly lower dose of Vitamin C, than before, that significantly

delayed his recovery. 14 Eventually, after nine weeks in a coma, Alan regained

consciousness and fully recovered.15

A. Cost comparison – Western Medicine versus Alternative Treatments

Alan’s nine-week estimated hospital room charges alone (adjusted for 2015 US

dollars16) were $136,570.17 Similarly, the estimated nine-week cost of his administered

antibiotic pharmaceutical drug, Tamiflu, was about $3,135.18 However, by a stark cost

savings comparison, had the doctors and hospital continued under Alan’s original treatment

alternative – the Vitamin C protocol – Alan’s estimated time in the hospital could have

been reduced to only fourteen days, as inferred from Alan’s 48 hour improvement trend.19

Moreover, his estimated cost of his hospital room charges alone, again utilizing the same

analysis above, but under the Vitamin C protocol, would be $30,380, and his estimated

14 Id. 15 Id. 16 US Inflation Calculator, Current US Inflation Rates: 2005-2015, http://www.usinflationcalculator.com/inflation/current-inflation-rates/ (last visited June 15, 2015). (Note that a 2014 inflation rate was 0.6% increase from the previous year and the 2015 estimated inflation rate for the first quarter is -0.1%. When calculating the impact/adjustment for 2015 inflation, the end result amount is negligible; therefore, reporting of 2015 inflation rate is considered a zero percent gain – virtually the equivalent inflation impact as year 2014.) 17 The Henry J. Kaiser Family Foundation, Hospital Adjusted Expenses per Inpatient Day, http://kff.org/other/state-indicator/expenses-per-inpatient-day/ (last visited June 15, 2015). (Provides average United States hospital inpatient room charges for the year 2014. This value was then adjusted for inflation from information obtained from note 16, supra, for a nine week – 63 day – total hospital room charge cost.) 18 Walgreens Pharmacy, Goodyear, Arizona, phone price verification of Tamiflu (Oseltamivir – 45mg, 30day prescription price verification on March 14, 2015. Although no specifics of Alan’s prescription of treatment was provided in the 60 minutes report, for some semblance of cost comparison, this value assumes three doses per day @ 16.59 per dose, for nine weeks – 63 days of hospital stay for the result supra). 19 See supra, n. 5. Id. (This value assumes that in a little over six days, Alan would regain 100% lung functionality, based upon the 30% functionality observed in the first 48 hours of Vitamin C administration. The fourteen days account for the assumption of typical time for initial patient intake, triage evaluation, diagnosis, treatment and subsequent release/discharge fitness evaluation.)

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Vitamin C administration costs are about $20.58 over fourteen days.20 The Doctors’ and

hospital’s appearance of not having Alan Smith’s best interests at hand is best summed up

by the nutritional and orthomolecular21 expert, Dr. Andrew Saul: “Good health makes a lot

of sense, but it doesn’t make a lot of dollars.”22 But for Mr. Alan Smith’s near death as

result of conventional allopathic perversity being averted by his family’s zealous and

vehement advocacy, Alan Smith would be yet another World Health Organizational

statistic of Swine Flu fatalities.23

Today's current medical treatment available to the sick is a no-choice, traditional,

pharmaceutical-based methods by predominantly allopathic doctors in the United States,

treating of a patient's symptoms and not the cause. Thus, leaving the patient subject to

contraindications of veritable side effects up to, and even including, death.24

Over 100,000 people per year are estimated to die due to complications of incorrect

pharmaceutical prescriptions to patients, by way of the western allopathic medical doctor.25

Allopathic medicine is that medicine that is considered medical orthodoxy that is supported

by scientific methods of basis of viability. 26 Conversely, medicine known as a

20 Healthy Habit – Health food Store, Phoenix, Arizona. (Store mean suggested retail price (“MSRP”) price check of oral Vitamin C on March 14, 2015 for powdered Vitamin C crystals (Ascorbic Acid) converted to a three-times per day oral dose – approximate 7500 milligrams – price for over the total fourteen days of hospital infirmity.) 21 Dictionary.com, http://dictionary.reference.com/browse/orthomolecular?s=t (last visited June 15, 2015). (Orthomolecular is being or pertaining to the treatment of disease by increasing, decreasing, or otherwise controlling the intake of natural substances, especially vitamins) 22DVD: James Colquhoun, et al., Food Matters: You are what you eat, Permacology Productions. May 30, 2008. 23 See supra, n. 5. 24 Barbara L. Atwell, Mainstreaming CAM in the Face of Uncertainty, 72 UMKC L. REV. 593 (2003-2004). 25 Id. 26 Michael John Weir, A new model for the regulation of Complementary and Alternative Medicine in Australia, Bond University School of Law, 14, 15 (2003) (Ph.D. Thesis on file with author).

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Complementary and Alternative Medicine (“CAM”) is considered by allopaths to be

medical “unorthodoxy” with more empirical bases for its effectiveness.27

This article proposes a change of law to establish a new fundamental right for a

person to have access, and choose, any available full-spectrum healing/treatment remedies

such as Complementary and Alternative Medicine, by all licensed healthcare providers.

Part II provides the background and development of our nation’s historical

conscience and traditions relating to society’s desire for medical choice freedoms that

never reached full potential benefit or for all. In particular, Part II addresses a 250-year, in-

depth, chronology of legal advances sought by original Founding Fathers, dating back to

the signing of the Declaration of Independence, up to the modern practice of current

medicine. Part II also discusses the self-imposed limitations of access to full spectrum

healing treatments at federal levels and the federal modern day challenges to a person’s

rights as mandated under the Affordable Care Act.

Part III is the states’ building toward a new fundamental right of medical freedom

framework that shows the state’s shift toward medical freedom, with recent Supreme Court

case precedent against self-regulation. The controversy is through western medicine’s

professional licensing restrictions against CAM professionals in free market competition.

Part III finishes with evidence that states have now began to accept CAM’s role, where

alternative medicine disciplines have begun forming and licensing alternative medicine

professionals.

27 Id.

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Part IV provides the legal analysis and justification for finding a fundamental right

of medical choice/freedom. Part IV relies upon prior Supreme Court case precedent

concerning the fundamental right doctrine to develop a legal analysis and demonstration

basis for the establishment of a new fundamental medical freedom/choice right.

Part V Identifies how the current federal structure of the U.S. Food and Drug

Administration is constraining to CAM as market participants – similar to the prior state’s

constraint on CAM as mentioned previously, in Part III. Part V proposes several ways to

restructure the U.S. Food and Drug Administration’s sub-organizations that are more

alternative medicine based into a better fitting, more logical structure under a new US

Department of Food. Finally, Part V proposes the restructuring of the U.S. Food and Drug

Administration to help the transition and recognition of the new fundamental right through

congressional legislative and administrative acts within the U.S. Food and Drug

Administration. Part VI concludes with final words on a change of law needed and the

establishment of a fundamental right of medical freedom.

II. THE FORMATION OF HISTORICAL CONSCIENCE AND TRADITIONS – BUILDING TO A NEW

FUNDAMENTAL RIGHT OF MEDICAL FREEDOM

A. The Genesis of a Medical Choice Fundamental Right in the United States – 1770s

The original basis of a person’s fundamental right to medical choice dates back to

the 1770s when the thirteen original colonies sought independence from the rule of

England.28 Dr. Benjamin Rush, who was the only physician who signed of the Declaration

28 Michael E. Horwin, War on Cancer: Why Does the FDA Deny Access to Alternative Cancer Treatments?, 38 CAL. W. L. REV. 189, 221 (2001).

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of Independence (and a personal physician to the United States first president George

Washington), said:

Unless we put medical freedom into the Constitution, the time will come when medicine will organize itself into an undercover dictatorship. To restrict the art of healing to one class of men and deny equal privileges to others will constitute the Bastille of medical science. All such laws are un-American and despotic.29

B. The Western versus Alternative Medicine Debate and the Flexner Report - 1908

Under the Carnegie Research Foundation, western medicine and the methods of

treatment, as understood today, in the United States established its origin in 1908 with the

publication of the Flexner Report’s recommendations about Medical Education in the

United States and Canada.30 The Flexner Report mandated that medicine would be based

on only proven scientific methods at medical schools affiliated or under a university

program.31 The result was the consolidation, or elimination, of private “store front” medical

schools.32 By 1935, the reduction in the amount of medical schools went from 151 down

to 35 and effectively locked western medicine into a scientific “Allopathic” heuristic –

virtually eliminating CAM, such as: homeopathy, naturopathy, chiropractic from modern

medicine as we know it today.33

29 Id. 30 Abraham Flexner, Medical Education in the United States and Canada: A Report to the Carnegie Foundation for

the Advancement of Teaching, Bulletin No. 4., New York City: The Carnegie Foundation for the Advancement of Teaching, p. 346, OCLC 9795002, Carnigie Foundation Archive, e-library, (1910) http://archive.carnegiefoundation.org/publications/medical-education-united-states-and-canada-bulletin-number-four-flexner-report-0 (last retrieved June 15, 2015). 31 Frank W. Stahnisch, et al., The Flexner Report of 1910 and Its Impact on CAM in 20th Century,1-5, Hindawi Publishing Corporation, Evidence-Based Complementary and Alternative Medicine. Vol. 2012. 32 Id. 33 Id.

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C. The Western versus Alternative Medicine Debate and AMTA in Congress - 1997

In 1997, the alternative medicine debate resurfaced again at the federal

congressional level with the introduction of the Access to Medical Treatment Act

(AMTA).34 Collectively, Congressman Berkley Bedell – before retiring from Congress due

to his disease afflictions – and Senator Tom Daschle, along with Senator Tom Harkin,

sought to advance the Access to Medical Treatment Act for legislative action.35 In support

of the bill, former Congressmen Berkley Bedell testified to a congressional committee

about the choice of western medicine and complementary medicine as related to the

encumbrance of his choice for medical treatment and availability to full spectrum healing

remedies.36 His testimony was:

I left Congress because I came down with Lyme disease. My Lyme disease was cured by a milk product at a cost of about $500 after pharmaceutical treatments costing an estimated $26,000 were not effective. I also came down with prostate cancer, and again it appears that a $600 alternative treatment was successful after it appeared that my surgery and radiation at an estimated cost of $10,000 had not cured my cancer. It breaks my heart to have to tell the Lyme disease patients who contact me because their pharmaceutical treatments are not curing them, that the cow's milk treatment that I believe cured me is not available to them because of government regulations….37

ATMA never made it out of the congressional committee and onto the congressional house

for legislative action.38

34 Michael Cohen, Holistic Healthcare: Including Alternative and Complementary Medicine in Insurance and

Regulatory Schemes, 38 Ariz. L. Rev. 83, 148 (Spring 1996). 35 Id. 36 Id. 37 Id. 38 Initial research showed publications about the 1997 ATMA bill only within secondary sources (i.e., law review articles) and attempts to research and locate any committee congressional annotations/historical notes were deadpan. For further verification, the conscription of an Arizona Summit Law School staff law librarian for further assistance in this aspect of research also proved to be unfruitful. A separate 2011 AMTA bill was introduced but it also was not

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D. The Western versus Alternative Medicine Debate Acknowledged by IRS - 201339

Interestingly enough, the IRS Code recognizes non-prescription remedies, such as

natural supplements, as a medical expense for tax deduction purposes provided the

supplements were prescribed by a licensed healthcare/medical professional.40 The use of

supplements for general health, well-being, and longevity without medical prescription are

not considered medical expenses for tax deduction purposes.41 Utilizing this designation

by the IRS sets some general policy and precedent for acknowledging the use of CAM in

the form of tax implications.

E. Affordable Healthcare Act and Medical Freedom of Choices - 2010

The passage of the Patient Protection Affordable Care Act (“PPACA”) in 2010,

opened the door to challenges in various forms against the mandate that requires either the

person to purchase health insurance or the payment of a shared responsibility payment to

avoid a penalty.42 One of the challenges embedded within PPACA, is the choice, from a

medical freedom standpoint, to not pay for insurance on unwanted medical services or pay

for insurance that covers services against one’s religious beliefs. For example, in 2013, in

U.S. Citizens Ass'n v. Sebelius, the Sixth Circuit Court of Appeals held that unwanted

medical care was not an implication of a fundamental right, in a challenge to the individual

enacted, according to the congress.gov tracking website. Reasons as to why no additional information was available regarding both bills is left to the inference of the reader. 39 Research of the IRS IRC Ruling publications in order to establish the time when the rule was enacted, indicates that this rule (through the IRC rule interpretation) became active sometime in 2013. 40 Internal Revenue Service, Publication 502, http://www.irs.gov/publications/p502/ar02.html#en_US_2014_publink1000179072 (last visited June 16, 2015). 41 Id. 42 U.S. Citizens Ass'n v. Sebelius, 705 F.3d 588, 601 (6th Cir. 2013).

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mandate under the PPACA.43 Also in 2013, in Korte v. Sebelius, a religious challenge to

PPACA, the Seventh Circuit Court of Appeals held that a woman’s contraception was a

substantial burden to a business such that the woman has no choice in health care as related

to contraception. 44 Finally, the wording contained within section 2706 of the Patient

Protection Affordable Care Act provides for no discrimination by providers. 45 This

provision is set for impending litigation, because the terminology within the Act centers on

the legislative intent. Did the legislature mean no discrimination by health insurance

providers and/or did the legislature intend the statement to refer to healthcare providers?46

Both sides of this meaning of intent are in rhetorical debate.47 The intent seems to be for

insurance providers, and is directed at both healthcare providers and patients. This sets the

legal argument for CAM’s coverage under the insurance provider coverage of the patient,

and subsequently mandates a track for CAM providers and users to gain bona fide

coverage, regardless of treatment modes (i.e, allopathic, integrative, or CAM).

F. Current Western Medicine State Regulation and Anticompetition

Currently, today’s western medicine is regulated at the state level through a “state

action” doctrine. A state’s adopted Medical Practice Act typically creates the scope,

43 Id. 44 Korte v. Sebelius, 735 F.3d 654, 687 (7th Cir. 2013) cert. denied sub nom. See also Burwell v. Korte, 134 S. Ct. 2903 (2014). 45 Patient Protection Affordable Care Act, H.R. 3590, 111th Cong. January 5, 2010 49 https://democrats.senate.gov/pdfs/reform/patient-protection-affordable-care-act-as-passed.pdf (last visited June 16, 2015). 46 Ankita Rao, Health Law Boosts Status of Alternative Medicine — At Least On Paper, July 24, 2013 (last visited June 16, 2015) (online interview with Naturopathic Dr. Jane Guiltinan, Dean of Bastyr University College of Naturopathic Medicine). 47 Id.

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authorization, and delegation of police powers to board members.48 The board members

are either appointed by a state’s governor, or elected and a majority of members are

licensed medical doctors who are active market participants in the medical community.49

The theory behind this majority structure is that the delegation made by the state legislature

leaves the regulating and police power to the persons who are knowledgeable in the area

of medicine. 50 In essence, the legislation is not sophisticated enough to regulate the

complex profession of medical doctors. 51 The majority of the board members are

professional members, in this case medical doctors, which provide self-administration and

regulation of professional licensure of the medical practice in order to protect the safety of

the public.52 The problem is that such board regulation, made up predominantly one type

of professionals (i.e., majority members are allopathic doctors), causes the possibility that

CAM practices are effectively and categorically shut out of any ability to effectively

compete with other licensees in the open medical practice market.53 This is analogous to

the contentious debate of non-lawyers practicing law in the context of Legal Zoom or Nolo

Law, whereby alternative access to legal documents that help render legal decisions is not

a viable option for the ABA recognized practice of law.54

48 Ray Anderson - Contributor, ehow.com, What is the Purpose of Medical Practice Acts?.

http://www.ehow.com/about_6391906_purpose-medical-practice-acts_.html (last visited June 16, 2015). 49 Federation of State Medical Boards, U.S. Medical Regulatory Trends and Actions, 6 May 2014 https://www.fsmb.org/Media/Default/PDF/FSMB/Publications/us_medical_regulatory_trends_actions.pdf (last visited June 16, 2015). 50 N. Carolina State Bd. of Dental Examiners v. F.T.C., 135 S. Ct. 1101, 1122 (2015) (from Supreme Court Justice Alito dissenting opinion). 51 Id. 52 See supra, n. 49. 53 Volokh Alexander, The New Private-Regulation Skepticism: Due Process, Non-Delegation, and Antitrust

Challenges. HARV. J. L. & PUB. POL’Y, Vol 37 July 2014 931-37. 54 See e.g., Goldfarb v. Virginia State Bar, 421 U.S. 773, 792 (1975); See also e.g., Bates v. State Bar of Arizona,

433 U.S. 350, 359-60 (1977).

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The paradox here is an administrative regulatory body delegated with professional

self-administration. This body is locked into a western medicine philosophy and is colored

by one heuristic mode of typical medical orthodoxy. Moreover, the body affects those

seeking to gain a healthcare provider license who do not fit within the medical orthodoxy

(i.e., a CAM doctor that is licensed to practice non-allopathic methods such as:

acupuncture, naturopathy, or homeopathy). Additionally, the paradox is framed in antitrust

law that proscribes anticompetition when the state action of the regulatory board is

regulating an industry in which they themselves are active market participants (i.e., medical

doctor board members regulating other medical doctors who compete together in the same

profession).55

For example, this type of state regulatory board behavior has been determined to be

anticompetition and a violation of the Sherman Antitrust Act as affirmed by the recent

United States Supreme Court’s decision in North Carolina State Board of Dental

Examiners v. Federal Trade Commission.56 In North Carolina State Board of Dental

Examiners, the technicians who provide teeth whitening for persons were in direct

competition with dentists and were blocked by the North Carolina Dental Regulation

Board, comprised of a majority of dentists, from providing teeth whitening services to

customers.57 The Court held that a board that is not an extension of a state and that the non-

sovereign actor controlled by active market participants — such as a board — enjoys

immunity, or allowed restraint on competition, only if the challenged restraint “is clearly

55 See supra, n. 54. 56 N. Carolina State Bd. of Dental Examiners v. F.T.C., 135 S. Ct. 1101, 1104 (2015). 57 Id.

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articulated and affirmatively expressed as state policy, and . . . the policy . . . is actively

supervised by the State.”58 In this aspect, the delegation of state regulatory power to a non-

sovereign entity (here, board of market participants that self-regulate) risks that the market

participants confuse their own interests with a state’s policy goals of protecting the public.59

In totality, this anticompetition legal framework foreshadows further mapping or

similarities to the Food and Drug Administration regulatory body. PART V addresses this

issue.60

III. THE STATE’S BUILDING TO A NEW FUNDAMENTAL RIGHT OF MEDICAL FREEDOM

A. The States’ Shift Towards Medical Choice

A legal implication as a result of the recent Supreme Court ruling in North Carolina

State Board of Dental Examiners deductively sets the stage for changes at state medical

boards within each state of the United States. Like the North Carolina State Board of

Dental Examiners, each respective state medical board within the United States a majority

of allopathic doctors, who self-regulate the profession, and could conceivably refuse,

block, mandate, or foreclose any use of CAM.61 Already, some medical boards are only

regulating the practice and unlicensed practice of allopathic medicine, resulting in the

regulation of some practices of CAM (i.e., acupuncture or homeopathy) by their own

58 Id. 59 Id. at 1106. 60 David Balto, Antitrust: The Problem and Solution for Health Care. It's a new world for health care, so old

antitrust solutions no longer work, U.S. NEWS & WORLD REPORT (April 12, 2013), http://www.usnews.com/opinion/blogs/economic-intelligence/2013/04/12/after-affordable-care-act-new-antitrust-laws-needed-in-health-care (last visited June 16, 2015). 61 Id.

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regulatory body of practice and arguably increase competition between the various

treatment/healing models.62

1. The Segue From State to Federal Regulation Anticompetition and its Challenges

Unfortunately, to apply this same heuristic from North Carolina State Board of

Dental Examiners to the federal level of U.S. Food and Drug Administration regulation

would not work, because congressional intent of U.S. Food and Drug Administration

regulatory control is to safeguard the public, which trumps any anticompetiton regulation

at the federal level; hence, the need for different structure that allows a grounding of CAM

and orthomolecular choice option prescribed by the healthcare provider (and paid for by

the insurance provider) that is ultimately demanded by the patient. Even if this model was

applicable, it is frustrated by the fact that possible intellectual property rights of secured

alternatives (i.e., drugs) would reduce the production of products, increase prices, and

ultimately force more regulation and centralization as a consequence.63

IV. THE FUNDAMENTAL RIGHT TO MEDICAL FREEDOM/CHOICE

Arguably, the undercover dictatorship may exist today, as foreshadowed by Dr.

Benjamin Rush in the 1770s. The monopolistic occupation of the western medicine has

outgrown its position of power in medical products, equipment – health care in totality.

The single-form, allopathic method originally founded by Flexner now occupies the field.

Once again, former Congressman Bedell’s testimony spoke of this day of reckoning:

62 See supra, n. 24. Id. at 594 (special attention to Arizona Homeopathic and Integrative Medicine Association (AHIMA) website: http://www.arizonahomeopathic.org/ as an example of the regulatory board that licenses and regulates Homeopathic Doctors). 63 See supra, n. 60.

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Be warned . . . there are some powerful forces that are doing very well financially under the present system. Pharmaceutical firms and some sectors of organized medicine are seriously threatened by alternative treatments. . . there are some powerful interests that would lose a lot of income. . . . [S]pecial interests can be expected to spend whatever is necessary, using their supporters and the press, some of whom they have convinced that all alternative treatments are “quackery.” . . . I am living proof that all such treatments are not “quackery.”64

A. Establishing a New Fundamental Right to Medical Freedom

The fundamental right that establishes the person’s medical freedom right to access

to full spectrum healing remedies can be found in the analytical framework outlined in the

case of Washington v. Glucksberg.65 There, the Supreme Court of the United States put

forth an analysis of substantive due process in determining a new fundamental right for a

person’s fundamental right to die.66 In particular, the Court applied two prongs: (1) the

fundamental right that protects liberties which are deeply rooted in the Nation’s history,

tradition and conscience of the people, and (2) a careful and cautiously worded description

of the asserted fundamental liberty interest (i.e, a detailed description of the fundamental

right).67 Moreover, the Court emphasized that the nation’s history and legal traditions are

crucial guideposts for reasonable determination of a fundamental right/liberty decision

making.68

64 Hearing on S. 2140 Before the Senate Labor/Disability Policy Committee (July 22, 1994) (testimony of former Congressman, Berkley Bedell). 65 Washington v. Glucksberg, 521 U.S. 702 (1997). 66 Glucksberg, 521 U.S. at 720-21. 67 Id. 68 Id.

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1. The New Fundamental Right Analysis

In applying the Washington v. Glucksberg two-prong analysis, the first aspect

protects a fundamental right in the conscience established and rooted by the United States’

early concerns. These concerns about medical freedom are confirmed by Dr. Benjamin’s

Rush’s statements recommending the placement of medical freedom somewhere within the

Constitution or Bill of Rights.69 Additionally, over 100 years later, Abraham Flexner,

during the early 1900’s, developed and revamped medical teaching institutions in order to

standardize and remove chicanery, quackery, and fraud; arguably, Flexner eradicated

virtually all CAM schooling and teachings from western medicine orthodoxy.70 More

recently, in 2013 when the IRS recognized the fundamental medical choice when it allowed

“medical” deductions for prescribed dietary supplements by licensed healthcare

providers.71 And in the 2010 enactment of the Affordable Care Act, and in legal challenges

to the Act involving religious or personal beliefs the medical choices are seen as

fundamental. Additionally, in recent years, looking at states’ separate regulation groups for

licensing CAM Homeopathic doctors, or acupuncturists, for example. With almost 250

years of repeated advocacy and governance, these are historical guideposts as indicated by

the Supreme Court placing a medical “homestead” claim for the people and therefore

satisfies the first prong of Glucksberg.

69 See supra, n. 37. 70 See supra, n. 31. 71 See supra, n. 40.

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The application of Washington v. Glucksberg prong two, careful and cautious

description of the asserted fundamental liberty, gathers aspects of Doctor Rush’s 1770s

medical freedom recommendations and some derivative language from the 2010 AMTA

house bill (not the 1997 bill).72 Such draft language might provide that:

No person’s right, to be treated by a health care practitioner with any medical treatment (including a medical treatment that is not approved, certified, or licensed) so long as treatment is within the practitioner licensing laws, that such person desires, shall not be abridged. No person’s medical freedom shall be denied equal protection or privileges to access full spectrum healing remedies.73

Consequently, the two-prong analysis of Washington v. Glucksberg provides the basis

for recognizing medical freedom as a fundamental right within the Fifth and Fourteenth

Amendments’ right to liberty – medical liberty.

2. Using the New Fundamental Right in the Alternative to Advance a Justiciable Claim

at the Supreme Court Level Under the Affordable Care Act Section 2706 of the Act.

The passage of the Affordable Care Act of 2010 one clause of the health law, in

particular — Section 2706 — is widely discussed in the alternative medicine community,

as an inroads for CAM providers, because it requires that insurance companies “shall not

discriminate” against any health provider with a state-recognized license.74 This means that

any alternative medicine provider that is state licensed – similar to the IRS recognition of

deductions for natural remedies/supplements that are prescribed by a licensed healthcare

72 See supra, n. 38. See also Access to Medical Treatment Act, H.R. 2736, 112th Cong., 1st Session, August 1, 2011 http://www.gpo.gov/fdsys/pkg/BILLS-112hr2736ih/pdf/BILLS-112hr2736ih.pdf (last visited June 16, 2015). See

also supra PART II, Section A: The Genesis of a Medical Choice Fundamental Right in the United States – 1770s. 73 Id. 74 See supra, n. 45.

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provider – must be reimbursed by medical insurance companies.75 Moreover, this section

arguably folds in a person’s implicit right to medical freedom.76 It is this Act that is ripe in

the near future for a person to raise a new fundamental right to medical freedom by utilizing

the Glucksberg two-prong analysis and an equal protection basis as suggested in Doctor

Rush’s medical freedom declaration in the 1770s.77 Finally, the provision of Section 2706

provides for infusion of CAM within other parts of the law in the form of wellness,

longevity health maintenance research.78

V. RESTRUCTURING OF THE FDA FOR FREE COMPETITION AT THE FEDERAL LEVEL

A. Restructuring to Foster the New Fundamental Right.

With the establishment of the new fundamental medical freedom right, comes the

legislative and administrative regulatory changes that would lead to a parallel universe of

existence for both allopathic and CAM/Orthomolecular remedies. The U.S. Department of

Food and Drug Administration, in its approval of new drugs for use in the treatment of

disease symptomology (as the underpinnings of western medicine and in keeping with the

findings and recommendations groundwork laid in the Flexner Report) also carry

derivative anticompetition elements as similarly held in North Carolina State Board of

Dental Examiners.79 However, the legal analysis case study, pre Supreme Court ruling, of

the case of North Carolina State Board of Dental Examiners does shed light on the

75 See supra, n. 46. 76 Id. 77 Glucksberg, See supra, n. 65. 78 See supra, n. 45. 79 See supra, n. 56.

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comparison.80 For example, the U.S. Food and Drug Administration routinely employs

previous pharmaceutical company executives and collects expedited fees from

pharmaceutical companies for expedited review and testing of New Molecular Entities

(“NMEs”).81 Review and testing under these fee payment settings, enable NME drug

approvals in as little as eighteen-months, as opposed to a normal six-year time period,

placing NMEs ahead of other possibly viable, life-saving, drugs when fees were too costly

to be paid.82 Consequently, it stands from this type of structure, that the U.S. Food and

Drug Administration (“FDA”) is self-regulating and has strong control of active market

participants. Furthermore, it follows that the FDA not only has influences in western

pharmaceutical medicine, but also its own sub-organizations: the National Institute of

Health (“NIH”) and the National Council of Complementary and Alternative Medicine

(“NCCAM”) – which CAM is under. 83 This inherently and deductively suggests the

existence of anticompetition by the FDA agency, because of the philosophical differences

between western and complementary medicine.84

1. The Current Federal Food, Drug, and Cosmetic Act – Modified to Topically Include

Dietary Supplements.

80 See supra, n. 53. Id. at 931. 81 MARCIA ANGELL, M.D., THE TRUTH ABOUT THE DRUG COMPANIES: HOW THEY DECEIVE US AND WHAT TO DO

ABOUT IT 26, 35 (2005) (Doctor Angell, for two decades at the New England Journal of Medicine and as the first woman to be former Editor-In-Chief, has had a front seat to the dealings with “Big Pharma” and the nexus between the NIH, FDA, Biotechnical Companies, and Conglomerate Pharmaceutical Companies). 82 Id. at 177-78. See also supra, notes 58-59. (Notice how the framework described in the FDA structure bears a very similar framework at the state level as described as footnotes 58-59 reference. Also this information was obtained as a result of review of the FDA and NIH websites for general organizational structure). 83 Id. 84 Id.

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In 1994, the natural supplement and vitamin industry was on the verge of complete

elimination from western medicine by pressure from the FDA. However, public outcry and

CAM industry leaders gained a small victory when producers of orthomolecular substances

(vitamins and supplements of natural derivation) gained acceptance into the FDA’s system

when it created the Office of Dietary Supplements through the 1994 amendment to the U.S.

Food, Drug and Cosmetic Act.85 Ironically, the concern of the FDA to regulate these

supplements is miss-matched with the fact that the supplements are considered a “food”

item and not a chemical that is subject to rigorous science based proof of effectiveness.86

Similar to the NIH’s research role for research of new pharmacological remedies (i.e.,

drugs), the office of Dietary Supplements is a sub-group under the umbrella of the NIH

and with some funding for research on the effectiveness and safety of proposed

supplements and natural remedies.87

2. The Current FDA New Molecular Entity Drug Approval Process

The current FDA regulates the food, drugs, and dietary supplements.88 The process

of obtaining approval for the use of a drug entails scientific double-blind clinical testing

with remarkable results before the pharmaceuticals are FDA approved and can go to

market.89 The NIH is federally funded institution responsible for sponsoring the research

85 Dietary and Supplement Health and Education Act of 1994, S. 784, 103d Cong., October 25, 1994 http://uscode.house.gov/statviewer.htm?volume=108&page=4325 (last visited June 16, 2015). 86 Protecting the Dietary Supplement Health and Education Act, ALLIANCE FOR NATURAL HEALTH http://www.anh-usa.org/dshea/ (last visited June 16, 2015). 87 About the Office of Dietary Supplements at the National Institutes of Health, NAT’L INST. OF HEALTH http://ods.od.nih.gov/About/ODS_Overview.aspx (last visited June 16, 2015). 88 About the FDA, U.S. FOOD AND DRUG ADMIN. http://www.fda.gov/AboutFDA/Transparency/Basics/ucm192696.htm (last visited June 16, 2015). 89 See supra, n. 76. Id. at 27-29.

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and development of NMEs into viable experimental drugs that ultimately are utilized in

human testing.90 Through federal funding, the NIH administers grant funding to research

institutions, a biotech business entity (typically as part of a university research group).

Pharmaceutical company(ies) partner with a biotech/university research group for optimal

timing of patent application purposes as a way to fast-track FDA and patent approval and

ultimate use as a viable pharmaceutical.91

3. The Current Structure of the FDA – NIH – NCCAM – ODS

The current structure of FDA houses the sub-group of National Institute of Health

(“NIH”) that advocates primarily for science-based research of typical inorganic

pharmaceuticals (i.e., drugs).92 Similarly, the National Center for Complementary and

Alternative Medicine (“NCCAM”) is also a competing interest sub-group directly under

the NIH within the FDA’s organization.93 NCCAM is also a science-based research body

of typical organic substances that promote healing or health (i.e., natural remedies).94

Lastly, the Office of Dietary Supplements (“ODS”) is another research department under

the NIH but appears not to have any monetary or budgetary connection to the NIH.95

Under the current model, the competing medical treatment philosophies are housed

within one operation unit: the FDA. This dynamic between the NIH, the NCCAM, and the

ODS is an intuitive, philosophical frustration between them and is analogous to the “quasi

90 Id. at 104. 91 Id. at 30. 92FDA Organization Overview, U.S. FOOD AND DRUG ADMIN. http://www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/ucm393155.htm (last visited June 16, 2015). 93 Id. 94 Id. 95 2015 NIH Budget appropriation on CAM 124509000 Page OA-4, NAT’L INST. OF HEALTH http://officeofbudget.od.nih.gov/pdfs/FY15/FY2015_Overall_Appropriations.pdf (last visited June 16, 2015).

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separation of powers” constitutional doctrinal framework (where no one branch has sole

and complete power, but when exercised by one branch, the other branches check the

asserting branch) as exhibited by the non-listing of budgetary monies within the NIH

annual budget report.

B. The Integrative Health and Medicine Act – Rebirth of Some Open Market Competition

As part of the federal FDA restructuring, it is logical and reasonable to seek

Congressional action that facilitates the advancement of a person’s fundamental right to

medical choice. One way to achieve this is through enactment of a new Integrative Health

and Medicine Act (“IHMA”) that incorporates derivative components of the last AMTA

bill put forth in 2011, plus key objectives, goals, and protections from Dr. Rush’s post

Declaration of Independence statements made about medical freedom. Although specific

particulars of the legislative act are beyond the scope of this article, the second prong of

the Glucksberg test, would require careful description of the fundamental right, to be

fashioned. The mission is to secure the vision of the fundamental medical freedom right

and yet still allow for inherent competition between allopathic and complementary

alternative medicines where ideally both can exist in an integrative setting.

C. The restructuring of the FDA – The Department of Food and The Department of Drugs

In addition to Congressional action to support recognition of the fundamental right,

essential FDA restructuring into two new separate regulatory agency divisions is needed:

The U.S. Department of Drugs (“USDD”), and The U.S. Department of Food (“USDF”).

The U.S. Department of Drugs would continue within the current structure and framework

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as existing today but with a severance of the National Center for Complementary and

Alternative Medicine and Office of Dietary Supplements from the FDA (the proposed U.S.

Department of Drugs), shifting under the new U.S. Department of Food division. (See

diagram below)

The U.S. Department of Food will utilize the National Center for Complementary and

Alternative Medicine as the research arm and approval process, similar to the National

Insititute of Health’s research division under the current FDA structure, but, instead,

research related to natural, non-allopathic modalities would be addressed, including:

remedies, equipment, and procedures. The Office of Dietary Supplements will also be

structured under the NCCAM as a support role of scientists, researchers, and evaluators

(similar to the old FDA branch) but again with a CAM expertise. Consequently, the idea is

to have two parallel universes that collectively advance medical sciences, in totality, by

each division under the umbrella of the IHMA.

VI. CONCLUSION

The new fundamental medical freedom right is viable within the American

traditions and conscience. The idea is to remove the despotic oppression of one aspect of

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medicine that chills competition by another, Complementary and Alternative Medicine.

Ultimately, the new structure can set the stage for lowering health costs, increasing

competition, raising the standards for health care and wellness, and eventually provide a

system that is in alignment with a person’s fundamental right to medical freedom.

Advancing the IHMA serves to structure harmonious collective medical health and

wellness care that enhances competition, reduces health care costs and promotes a quality

of life sustainable to all Americans.