The International Publication Planning Association’s 2010 ... · 6 Nolan C. The International Publication Planning Association’s 2010 Midwest Meeting. May 2010. About the author

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The International Publication Planning Association’s 2010 Midwest Meeting:tackling the authorship debate in publication planning

in-depth report from a meeting held in Chicago, Illinois, USA, 25–26 February 2010

by Clare Nolan

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The International Publication Planning Association’s 2010 Midwest MeetingFirst published May 2010 by NetworkPharma Ltd 89 Oxford Road, Oxford OX2 9PD, UK Tel: +44 (0) 1865 865943 Web: www.networkpharma.com email: [email protected]

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Nolan C. The International Publication Planning Association’s 2010 Midwest Meeting. May 2010. www.KeywordPharma.com 3

The International Publication Planning Association’s 2010 Midwest Meeting:tackling the authorship debate in publication planningin-depth report from a meeting held in Chicago, Illinois, USA, 25–26 February 2010Executive summary

The global landscape for medical publications planning is changing dramatically. With guidelines and regulations acknowledged as the most prominent tools for implementing sound scientific publication practice, the regulatory environment has been tightened in recent years while further recommendations are on the horizon.

Critics allege that nowadays it is difficult to separate the pharma industry’s advertising and marketing from the science. Confidence in the industry is low. So how can progress be made? Developing a global one-size-fits-all policy is compromised by significant differences in global and local requirements. Without a uniform approach, self-advocacy is highlighted as a key route to cleaning up the industry’s act and re-establishing confidence. Transparency, integrity, accountability and disclosure are heralded as the best means of achieving success. Introducing more guidelines, however, is not considered to be the answer. Instead, collaborative working between organisations who share the objective – to ensure that publications policies are completely explicit – is seen as the way forward.

This Conference Insights review provides an in-depth review of The International Publication Planning Association’s 2010 Midwest Meeting: tackling the authorship debate in publication planning. It details the most salient issues driving publication planning in a much-scrutinised and ever-changing environment. In particular it focuses on:

• current and imminent regulations• author selection• the battle to distinguish between scientific exchange, education and promotion• developing an adequate audit trail• defining the role of the agency• the importance of disclosure• developing and sharing a comprehensive publications policy.

It looks at the latest legal and compliance issues, providing perspectives from editors, authors, pharmaceutical companies, agencies and regulators seeking to establish how standards can be improved.

ContentsProgramme 4About the author 6Managing global publications: the publication planner’s toolbox 7Managing global publications 9How can we re-establish confidence in the industry? 10Legal and compliance issues for publication planners 12Do you have an adequate audit trail? 13

Balancing the value and perceived bias inherent in review articles 14What makes an efficient, effective relationship? A medical communications agency perspective 15Authors’ perspectives on the changing landscape 16Conclusion 17References 17

4 Nolan C. The International Publication Planning Association’s 2010 Midwest Meeting. May 2010. www.KeywordPharma.com

The International Publication Planning Association’s 2010 Midwest Meeting – Programmein-depth report from a meeting held in Chicago, Illinois, USA, 25–26 February 2010

Day one

The publication planner’s toolbox: an interactive workshopSession Leader:Tricia Deja (Senior Manager, Medical Publications, Astellas Pharma Global Development, Inc.)

Managing global publications – an application of the conceptsSession Leaders: Maureen Garrity (Director of Publications, Astellas Pharma Global Development, Inc.)Keith Veitch (Head Global Publications, Novartis Vaccines)

Day two

Chairperson: Maureen Garrity (Director of Publications, Astellas Pharma Global Development, Inc.)

Can we re-establish confidence in the industry? The case for self-advocacyPanelists: Dr Tony Delamothe (Deputy Editor, BMJ)Cindy W Hamilton (Immediate Past President, American Medical Writers Association)Jennifer L Riggins (Board Member, Drug Information Association)Gene Snyder (Division Lead, UBC-Envision Group and Past President, ISMPP)

Moderator: Art Gertel (VP, Strategic Regulatory Consulting, Medical Writing & QA, Beardsworth Consulting Group, Inc.)

Update! The latest hot-button legal & compliance issues for publication plannersSpeaker: Alan G Minsk (Partner, Arnall Golden Gregory LLP)

Do you have an adequate audit trail? Crucial steps to ensure your level of transparency stays ahead of the curveSpeaker: Gene Snyder (Division Lead, UBC-Envision Group and Past President, ISMPP)

Balancing the value and perceived bias inherent in review articlesSpeaker: Dr Tony Delamothe (Deputy Editor, BMJ)

A medical communications agency perspective on what makes an efficient, effective relationship: the good, the bad, and the uglySpeaker: Neil Matheson (Chief Executive Officer, Huntsworth Health)

Panel discussion: authors share their perspectives on the changing landscapePanelists: Larry H Danziger (Interim Vice Chancellor for Research, University of Illinois at Chicago, Professor of Pharmacy Practice, Co-Director of the Section of Infectious Diseases, College of Pharmacy, Department of Pharmacy Practice)Jay L Goldstein (Professor of Medicine, Vice Head for Clinical Affairs, Department of Medicine, University of Illinois at Chicago)Michael A Becker (Professor Emeritus of Medicine, University of Chicago)

Moderator: Elizabeth Crane (Senior Manager, Medical Publications, Astellas Pharma Global Development, Inc.)

Open forum: the take awayModerator: Maureen Garrity (Director of Publications, Astellas Pharma Global Development, Inc.)

www.ThePublicationPlan.comIncludes details of future events

for publication planning specialists

www.publicationplanningassociation.org


About the author

Clare Nolan is a co-founder of The Recognition Academy, a training company that helps physicians and the pharmaceutical industry work together. She has over 20 years’ experience in drug development and brand commercialisation within academia and the pharmaceutical industry.

After obtaining a degree in pharmacy and a PhD in prostate cancer drug development from Cardiff School of Pharmacy and Medicine, UK (sponsored by the Cancer Research Campaign), Clare worked at Eli Lilly & Company and Lilly Research in neuroscience product development, clinical

trial design and sales. As a Regulatory Manager at GSK, she led European license submissions for new cardiovascular products and in-licensing agreements in respiratory products. At Strategic Consultants International, she led clinical development advisory boards and continuing medical education programmes throughout Europe, the USA and Asia. At AstraZeneca, she was responsible for global publications and communications from early pipeline and prelaunch to postlaunch for products in oncology, urology, immunology and cardiovascular and infectious diseases. On behalf of academia and industry, she has established global opinion leader networks, profile management tools and company-wide opinion leader relationship management systems. Clare has trained global cross-functional teams on publications issues and challenges, internal policies and external guidelines. Most recently, as Director of Professional Development with Lionsden Communications, she has trained opinion leaders and emerging leaders in spoken communication, to their peers. She is a member of ISMPP.

As a Director at The Recognition Academy, Clare trains physicians on how to partner with the pharma industry so they can gain recognition for their contribution to medicine with enhanced reputation and credibility. The Academy also trains industry professionals to partner effectively and ethically with physicians, enabling them to advance patient care whilst upholding their reputation.

Clare can be contacted at [email protected] or via www.recognitionacademy.com; Twitter: @clarejo Linkedin: http://uk.linkedin.com/in/clarenolan

www.ThePublicationPlan.comThis is a freely accessible online resource for everyone

involved in publication planning

Special 20% discount offer for members of our community

GETTING RESEARCH PUBLISHED: an A-Z of publication strategy 2nd Edition

Written by Elizabeth (LIz) Wager

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ISBN: 9781846194085 Published March 2010

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Managing global publications: the publication planner’s toolbox

With many different stakeholders to consider, publication professionals must navigate their way through a sea of guidelines and regulations, and be cognisant of what is ahead. With new recommendations and requirements on the horizon, it is clear the publications industry is changing dramatically.

Tricia Deja (Astellas Pharma) opened the first pre-conference workshop, on behalf of Liz Wager (Sideview), who was unable to attend the meeting, with an overview of existing publication guidelines and regulations, placing emphasis on the differences between them (Table 1).

The International Committee of Medical Journal Editors (ICMJE) guidelines1 provide guidance on a wide range of topics, including authorship/contributorship, overlapping publications, prior publication, conflicts of interest, dealing with the press and trial registration among others.

The Good Publication Practice guidelines (GPP1 and GPP2)2,3 have the widest scope of all the guidelines currently available, addressing areas such as publication bias (suppression of negative findings), redundant publication, relations between investigators and trial

sponsors, the role of professional medical writers, data access, publication steering groups, publication agreements, disclosures, payment for authors and defining the role of publication professionals and publication planning.

The American Medical Writers Association (AMWA) guidelines7 are aimed at individual writers (rather than the companies they work for), and cover ethics, contributorship and acknowledgements when assisting with peer-reviewed publications. The European Medical Writers Association (EMWA) guidelines4 are also aimed at individual writers, and are similar to the AMWA guidelines and GPP in that they include specific emphasis on competing interests.

Developed by the World Medical Association with regard to the ethics of medical research involving human subjects, the Declaration of Helsinki (2008 revision)5 states that every clinical trial must be registered and that authors, editors and publishers have ethical obligations. Authors have a duty to make results publicly available and are accountable for the completeness and accuracy of the reports. Negative as well as positive results should be published or made publicly available, and sources of funding, affiliations and conflicts of interest should be declared.

Deja drew participants’ attention to an anti-ghostwriting checklist, published in February 2009.8 A series

The International Publication Planning Association’s 2010 Midwest Meeting:in-depth report from a meeting held in Chicago, Illinois, USA, 25–26 February 2010

International Committee of Medical Journal Editors (ICMJE)1

Good Publication Practice guidelines (GPP1 and GPP2)2,3

European Medical Writers Association (EMWA)4

Declaration of Helsinki5

Pharmaceutical Research and Manufacturers of America (PhRMA)6

Authorship X X X X

Acknowledging funding X X X X

Professional writers X X

Redundant publication X X X

Publication bias X X X

Sponsor control of publication/veto X X X X

Table 1. A summary of the coverage offered by some of the publication guidelines currently available. Reproduced with permission from Liz Wager (Sideview).


of articles entitled ‘What should be done to tackle ghostwriting in the medical literature?’, posed a series of questions to both the medical writer and the author. These include establishing whether the author meets the criteria specified by the ICMJE and ensuring that the funding source for the medical writer is clearly identified (Table 2).

New regulations involving clinical trial registration and results posting have also come into force. The latest enactment of the US Food and Drug Administration Amendments Act (FDAAA) mandates that adverse event data should now be reported as part of the results posting and further rulemakings are pending in 2010. Also in 2010, the US state of Maine has introduced new requirements for the disclosure of ‘observational’ studies and post-hoc analyses. In Europe, the roll-out schedule for registration and results posting of all applicable European clinical trials commencing on or after 1 May 2004 onto the European Database on Clinical Trials (EudraCT) has now been released. Trial registration

must be complete by Q2 2010 and results posting is scheduled for 2011. Further information is provided at eudract.emea.europa.eu.

New regulations involving clinical trial registration and results posting have been enacted

For those needing information, there is an online subscription database providing information about public clinical trial registration and results disclosure requirements for individual countries around the world. TransparentCT® (transparentct.com) is a comprehensive source of information that will save trial sponsors and others valuable time and resources by providing browser-based access to, among other things, information on different country requirements, registries and results databases, and laws and regulations.

As additional agencies institute other mandates relating to results reporting, the publication climate is likely to change dramatically. Currently, the ICMJE do not consider results data posted in the tabular format required by ClinicalTrials.gov to be prior publication, as the data have not undergone independent peer review. However, the ICMJE may need to amend their recommendations if agencies institute other mandates that require more detailed descriptions of trial results beyond those currently included in ClinicalTrials.gov.

As an aside, Deja went on to talk about science journal editors’ views on publication-related guidelines and regulations. A 2009 international survey (Table 3)9 involving 524 (231 responding) Wiley-Blackwell journal editors from the medical, healthcare, life science and social science sectors found that most editors were not very concerned about publication ethics.

Editors were also generally unfamiliar with the current guidelines (Table 4) and mostly believed that problems occurred only rarely in their journals (less than once a year). Reassuringly, perhaps, the survey also found that journal editors would appreciate more training and resources.

Questions

1.

2.

3.

4.

5.

(a) Did the medical writer meet the three criteria for authorship, as specified by the ICMJE?

(b) If not, has the writer been identified in the acknowledgements or as directed by the journal?

Has the source of funding for the medical writer’s services been identified in the acknowledgements or as directed by the journal?Did the author(s) make the final decision on the main points to be communicated in the manuscript, particularly in the conclusion?Did the author(s) make the final decision on the primary and secondary outcomes and the relevant data to be reported in the manuscript?If requested by the journal, can the medical writer provide evidence that the manuscript was prepared in accordance with international guidelines for ethical medical writing (e.g. Uniform Requirements for Manuscripts Submitted to Biomedical Journals; Good Publication Practice for Pharmaceutical Companies; Position Statements from the European or American Medical Writers Associations or the International Society for Medical Publication Professionals?)

Table 2. An anti‑ghostwriting checklist. Reproduced from Gøtzsche PC et al. PLoS Med 2009;6:e23,9 under a Creative Commons Attribution License.

• Falsified or fabricated data

• Image manipulation

• Plagiarism

• Redundant publication

• Duplicate submission

• Gift authorship

• Ghost authorship

• Disputed authorship

• Undisclosed author conflicts of interest

• Undisclosed commercial involvement

• Undisclosed reviewer conflicts of interest

• Reviewer misconduct

• Unethical research design or conduct

• Concerns over supplements

• Concerns over advertising

• Editorial interference by journal owner

Table 3. An international survey of journal editors covered awareness of and concerns about 16 publication ethics issues. Reproduced with permission from Liz Wager (Sideview); adapted from Wager et al.9


Science journal editors are not very concerned about publication ethics

Other significant changes include the move toward implementing authorship agreements/contracts to outline expectations in alignment with company publication policies, a uniform approach by journals regarding conflict of interest disclosures and, potentially, the public reporting of payments made to physicians and patient advocacy groups.

As well as a US national payment programme, as suggested in a recent Institute of Medicine report,10 there is the possibility of US legislation. The Physician Payments Sunshine Act of 2009 could mandate disclosure of industry gifts and payments to physicians on a federal website. The first report is due 31 March 2011, with public disclosure from 30 September 2011. Penalties will range from $1000 to $100,000 for payments that are not reported.

In addition, an increasing number of journals are beginning to demand trial registration, submission of (or access to) trial protocols, details of contributions, details of payment/competing interests, information about the article ‘background’ and data disclosure statements. For example, Annals of Internal Medicine now publish a statement with every original research article indicating the authors’ willingness to share with the public the study protocol (original and amendments), the statistical code used to generate the results and the dataset from which the results were derived.

Annals does not require the sharing of these items, but the journal does require authors to state their willingness to share, and any conditions for sharing. Access to these items may range from completely unrestricted (e.g. free availability of all the items via posting on an open-access website) to restricted (e.g. availability of certain portions of the items to approved individuals through written agreements with the author or research sponsor).

Deja concluded by stating that guidelines and regulations are the most prominent ‘tools’ for implementing good, sound scientific publication

practice. Further exposure to and training in these tools will encourage their adoption. Deja also predicted that publication professionals should watch out for a range of future changes, including some relating to:

• authorship of reports

• identification of the principal investigator

• the use of trial identifiers in abstracts

• peer reviewer conflict-of-interest disclosures

• requirements for reporting payment to third-party vendors for publication support

• the publishing of reviewers’ comments.

Guidelines and regulations are the most prominent ‘tools’ for implementing good, sound

scientific publication practice

Whatever the future holds, being aware of all new recommendations and requirements will facilitate preparedness for any impact on both companies and the role of publication professionals.

Managing global publications

Keith Veitch (Novartis Vaccines) and Maureen Garrity (Astellas Pharma) led a second pre-conference workshop on the biggest issues publication professionals face in their role today.

On enquiry to the audience, one-third of company participants indicated that they have a global publications policy in place. For the remaining two-thirds, the barrier to establishing a global one-size-fits-all policy was the difference between global and local requirements.

By way of example, participants were asked to consider the following: a manuscript has four authors and is intended for publication in a journal with global readership.

Guidelines Unaware (%) Aware but not used (%) Used (%)

ICMJE 55 21 24

GPP 67 24 9

EMWA 71 22 7

Council of Science Editors 80 13 7

World Association of Medical Editors 79 11 10

Committee on Publication Ethics 51 20 29

Wiley-Blackwell guidelines 31 32 37

Table 4. The results of an international survey of science journal editors’ awareness and usage of publication‑related guidelines. Reproduced with permission from Liz Wager (Sideview); adapted from Wager et al.9


Two authors are from the USA and two are from Germany. With no global policy in place, the conventions and expectations for determining authorship for the US authors might differ from those for the German authors. If the target journal for this manuscript is Indian, which policy should publication professionals use as their guiding principle? Certainly, publication professionals need to educate regional and global colleagues about the requirements for US authors, especially as there is increased anxiety among US authors themselves when contacted by company publication professionals from outside the USA.

There was general agreement that a global model would be the best approach. However, if such a model is based on ICMJE guidelines, the issue of regional variations due to local interpretations and language differences will remain. So what else would the policy contain other than ICMJE criteria? Would it be all-encompassing and apply to all functions, including clinical and outcomes research? What about redundant publications? How would they be handled?

The audience recognised that educating and influencing top management to give global publication policy their top priority is no small feat.

How can we re-establish confidence in the industry?

Following a heartfelt welcome to the main body of the meeting, Chairperson Maureen Garrity (Astellas Pharma) introduced a dynamic and experienced panel, whose challenge was to guide us through the thorny issue of how to re-establish confidence in the publications industry. “Is self-advocacy and networking the way to move forward?” she asked the panel.

Reflecting on a time when science from the pharmaceutical industry was admired, Art Gertel

(Beardsworth Consulting Group), a Past President of AMWA, and a Fellow of both AMWA and EMWA, talked about an image that had been tarnished and a need to bring the industry’s reputation back to what it was.

The ghostwriting controversy has featured repeatedly in The Wall Street Journal, The Lancet, BMJ and many other journals. In November 2002, former New England Journal of Medicine editor Arnold S Relman stated “You cannot separate their [the pharmaceutical industry’s] advertising and marketing from the science any more”. An article in The New York Times11 called for a ban on pharma adverts in medical journals. Their most recent article by John Tierney published in January 201012 heralded that conflict-of-interest accusations have become the simplest strategy for avoiding substantive debate.

Self-advocacy was proposed as a way forward and defining the realm in which we operate is therefore important. Gertel stressed that we should be clear about advocacy. What is advocacy? To whom should we advocate? How should we advocate? For whom should we advocate? As advocates, publications professionals can bring a perspective that will impact on how well the industry’s publication efforts are received.

Cindy Hamilton (a Past President of AMWA) described how AMWA has been promoting excellence in medical writing since 1940. A code of ethics, educational programmes (Fig. 1) and research promotion are central to AMWA’s approach to medical writing. Yet, despite these long-standing efforts, a recent Wall Street Journal13 article implied that measures such as these were not working. AMWA has duly responded by raising quality standards in its educational programme and by adding a third level. The first level will focus on essential skills for all medical communicators and will be a prerequisite for the other levels. An ethics workshop is now mandated at each level. Another key difference is that the Code of Ethics is included on the AMWA membership form. Lastly, AMWA expanded its awards programme to include two new awards created to further promote and

What’s the history of AMWA’s Code of Ethics?

What’s the history of AMWA’s Educational Programme?

Fig. 1. The histories of AMWA’s Code of Ethics and Educational Programme. Reproduced with permission from Cindy Hamilton (a Past President of AMWA).

• Code adopted (revised 1989, 1994 and 2009)1973

2002• Position statement adopted

2009

• Code added to membership form

• First annual conference (open sessions)1941

1979

• Core certificate programme

2010

• Expansion of certificate programme


support research. About ghostwriting, AMWA’s position is clear:

1. acknowledge the contribution of the medical writer

2. disclose the funding.

Discussions moved on to AMWA’s European counterpart, EMWA (the European Medical Writers Association). EMWA is an established European network of medical communicators. Created in 1992, it also has an Educational Professional Development Programme and more than 100 workshops in place for training its 900-strong membership across 35 countries.

So, have the initiatives these organisations have implemented made a difference? The results of a survey presented at the International Congress on Peer Review and Biomedical Publication in 200914 show that there was a reduction in the number of ghost authors between 1996 and 2008, from 11% to 8%, suggesting that the changes that have been implemented, albeit small, have had a positive impact.

Despite these increased efforts, there remain some journals that add fuel to the fire by not accepting articles if medical communicators disclose their involvement. Sometimes collective lobbying from organisations such as AMWA and EMWA is required to change a journal’s policy, as was the case with The Clinical Journal of Oncology Nursing. After receipt of a combined letter from AMWA and EMWA, the journal repealed their ban.

A survey of AMWA and EMWA membership15 found that an increase in familiarity with and awareness of GPP1 and ICMJE guidelines produced increases in acknowledgements of editorial support. The survey also showed that the absence of acknowledgement of writing support is more likely with review articles or with articles written by freelance writers.

Now in its sixth year as a non-profit organisation, the International Society for Medical Publication Professionals (ISMPP) has become an established

advocate for the publications professional, with a vision to be a recognised and respected authority for the profession. It is setting standards by its framework to advance advocacy through education (Fig. 2). Gene Snyder (UBC-Envision Group), a Past President of the ISMPP, stated that the society promotes the adoption of transparency about what publication professionals do and how they do it. He said that “Our education initiatives will help to combat the misperceptions surrounding the role among stakeholders and the public, as well as raise standards in the profession itself. ISMPP is passionate. We care, we are proud and whilst we want the profession to be represented properly we acknowledge that advocacy takes both time and money.”

“ISMPP is passionate. We care and we are proud”

The third organisation represented on the Panel was the Drug Information Association (DIA). As a global multidisciplinary professional association, the DIA provides neutral educational forums for the four major pillars of the drug development community, namely academia, government/regulatory, industry and patients. It fosters knowledge exchange and innovation to raise the level of health and well-being worldwide. Representing the DIA Board of Directors, Jennifer Riggins emphasised the need to establish and adhere to core values in publications. Top of the DIA’s list of values are transparency and integrity, accountability and trust. These are values they share with AMWA, EMWA and ISMPP. DIA also define core competencies within the medical writing special interest area community (SIAC). The medical writing SIAC core competencies are expertise in science, writing and communication, along with project and relationship management, leadership and influencing skills.

The final member of the panel was Tony Delamothe, Deputy Editor of the BMJ. Delamothe said that he was “fascinated”

Fig. 2. ISMPP’s advocacy platform by audience. Reproduced with permission from Gene Snyder (Past President, ISMPP).

ISMPP Members

• Clearly demonstrate advocacy support that ISMPP is providing to profession

Profession• Continuing to educate and raise standards related to best practices & specific areas of misunderstanding

All external parties

• Improve understanding of the value of medical publications & the role of MPPs

Press and public

• Proactively educate on ethical standards & best practices; respond to professional scrutiny & criticism


by the perceived need to re-establish confidence in the publications industry, as this suggests that there was once a Golden Age. In his opinion, there had never been a time when there was complete confidence in the medical writing and publications industry. As an editor, he had no current anxieties about the publications industry, and was impressed with the ethics and competence programmes already in place. He pointed out, however, that it was no surprise that people choose the easiest option and elect to submit articles to journals with fewer disclosure regulations.

However, Delamothe admitted that, until recently, journal editors have had little direct interaction with the publications industry and, hence, their knowledge of and relationship with the industry have been non-existent. Journal editors therefore remain ignorant about who the publication stakeholders are, and how their roles, responsibilities and experience relate to the publication of an article. Realising that journals are now perceived to be part of this industry, and are perhaps being tarred with the same brush, editors are recognizing that they have to work with other members of the industry in order to protect their reputations.

More guidelines are not the answer

Whilst AMWA has been ahead of the game with its code since 1940, Delamothe was of the opinion that more guidelines are not the answer. He made the point that several organisations were represented at the meeting, all attempting to do the same thing, with striking consistency. Delamothe suggested that these organisations should come together to collaborate on strategy and make the aims within the medical writing and publications industry completely ‘explicit’. While acknowledging that collaboration will require extensive coordination and commonality of purpose (including interaction with the Council of Scientific Editors), he asked the panel and meeting participants whether there was now enough common ground for individuals to speak on behalf of everyone as one body? Whilst there may be a lot more work to be done, would this be the right time for a coalition of efforts as a joint force? Is there also an opportunity to collaborate and initiate a research project looking into some specific cases? He suggested that the findings of such a project could form part of the AMWA Research Award.

Reflecting on the discussions of the panel, Delamothe wondered whether the journey already gone through had created a community that would metamorphose into something even more wonderful.

Legal and compliance issues for publication planners

From a legal perspective, Alan Minsk (Arnall Golden Gregory) talked about hot button legal and compliance

issues for publication planners: what can be done, what can’t be done and what (for US firms) the attorneys will ask.

Currently, the focus is on author selection. Attorneys are asking companies how they went about selecting clinical investigators and authors. They want to know who picked a particular author and whether marketing personnel had been involved. They are asking about payments, standard operating procedures and corporate integrity agreements (CIAs). Minsk advised that it is important to engage authors for the right reasons, to ensure that they can bring appropriate clinical perspective and that they have the authority from their academic institutions to write an article. He suggested including representatives from the medical, legal, compliance and regulatory departments in the selection process, and to avoid author selection by a single person. It is important that everyone in the company knows who their compliance officer is, should they have any questions.

In August 2009, US Senator Charles Grassley sent a letter on behalf of the Senate Finance Committee to the National Institutes of Health (NIH) expressing concern over recent news stories about the professional ghostwriting of articles on hormone replacement therapy for a major pharmaceutical company. The letter requested that NIH report its policies on ghostwriting for NIH researchers and grant recipients. This government communication follows a wave of scrutiny of the relationship between companies, academic institutions and authors.

Some medical and academic institutions are responding to concerns about ghostwriting by imposing restrictions on personnel. In 2009, Columbia University implemented a new policy prohibiting medical school faculty, trainees and students from authoring or co-authoring articles written by employees of commercial entities in cases where the author’s name or Columbia affiliation is used without substantive contribution. The policy also requires any article written with a for-profit company to include full disclosure of the role of each author, as well as any other industry contribution.

“Don’t overstate, understate or misrepresent. Tell the entire story”

The FDA acknowledges the use of publications for information dissemination, and is currently interested in setting up a contextual framework for the dissemination of articles about unapproved uses of drugs or medical devices. In a bid to distinguish between scientific exchange, education and promotional spin, the FDA has released a guidance document, ‘Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices’.16

ISMPP has clearly defined the boundaries and parameters for the development of medical publications


in GPP2. Whilst there are some areas of commonality between the FDA guidance and GPP2, it should be noted that letters to editors, abstracts, phase I clinical trial reports and reference publications containing little or no substantive discussion of the investigation are not included in the FDA’s guidelines. The FDA does allow companies to hand out books/articles about off-label use under certain circumstances. However, Minsk cautioned companies to be careful not to abuse the guidance by orchestrating an unlawful seeding/pre-approval/off-label promotional campaign. “Don’t overstate, understate or misrepresent. Tell the entire story, not only the good news”.

The fact remains that about 80% of FDA enforcement letters relating to product promotion involve minimisation or ommision of risk information. The scenario of a group of experts invited by industry or an industry third party to write a white paper to use with a patient group with the aim of changing treatment guidelines is seen as a false claim. If the product label says ‘no’ to an indication but a publication says ‘yes’, this is seen as intent.

So, as Government looks into publications more closely, what are the implications for non-compliance with regulations? In 2009, a major US pharmaceutical company entered into a CIA with the Office of the Inspector General (OIG), who required the company to:

• develop disclosure policies for authorship of articles

• ensure that health professionals or entities that produce articles are properly listed as ‘authors’

• maintain written author agreements describing the scope of work, fair market-value fees and compliance obligations

• establish a publication-monitoring programme to audit activities and report to the OIG

• oversee author compliance with ICMJE criteria regarding authorship and corporate relationship disclosure.

Corporate integrity agreements notwithstanding, the implications of non-compliance include the potential for loss of credibility with consumers and the medical community, bad publicity or the need for corrective advertising, US state prosecution and a potential negative impact on the stock price.

Do you have an adequate audit trail?

Minsk’s expert knowledge of the latest legal and compliance issues was the perfect lead into a presentation from Gene Snyder about the world of audit within the publication planning space (Table 5). He asked the meeting participants a number of thought-provoking questions, including: do you believe you are prepared for an audit? Do you have an adequate

audit trail? Could you prove that you have followed your publication policy? Do you have any comments that suggest inappropriate influence?

Audit is a good thing and Snyder encouraged all publication professionals and their teams to support it. As a test of the validity and reliability of internal policies and controls, an audit can extend for up to 10 years. It gives you reasonable assurance that your controls are being met and therefore adds credibility to the publications process and role.

The International Organization for Standardization (ISO) is an international standard-setting body. A company or organisation that has been independently audited and certified to be in conformance with ISO 9001 may publicly state that it is ‘ISO 9001-certified’ or ‘ISO 9001-registered’. This is not a guarantee of compliance (and therefore quality); rather, it certifies that consistent business processes are being applied.

Auditors want to know if what the company is telling them is true. Are there instances when they have gone outside the policy and process? Are there any emails to the marketing department requesting a review? What information has been removed from one version of a manuscript to the next? Where is the author identification trail and has there been any mid-stage addition of authors? Are there any inconsistencies across the organisation (it only takes one good example)? Has there been any violation of the publication timeframes specified by the FDAAA?

An auditor is looking for fewer internal reviews and any comments suggesting inappropriate influence from the company.

For a publications professional to feel comfortable and secure that the company will not have to pay a monstrous fine, they need to be sure of their team’s understanding of policies and how policy becomes practice. Consider if the same processes are being used across different functions as well as across different regions or geographies. Were the authors involved throughout and have any authors been dismissed? Defining an external agency’s role is fundamental and ensures that the agency understands its as well as the company’s role. Have study funding, internal author identification and medical writer contribution been disclosed?

• An official examination and verification of accounts and records, especially financial

• A report or final statement of account

• An inspection or examination of a building or other facility to evaluate or improve its appropriateness, safety, efficiency, or the like

Table 5. Official definitions of an audit.


The audit lifecycle (Fig. 3) is a useful tool that breaks down the process into its four component phases:

• development

• adoption

• action

• improvement.

More than 50% of companies represented at the meeting would be classed as being in the development phase as they do not have a comprehensive publication policy in place.

Emphasis is placed on implementing a publication policy and then ensuring that there is continuous training for new and existing team members. Recently, a company failed a voluntary internal audit to determine their adherence to public disclosure of clinical trial data across the board, despite having an established global publication policy. The reason: they had failed to train internal teams, agencies or investigators about the company’s policies and processes.

It may be possible for company publication professionals to help the compliance team define the compliance standards in relation to the policy. When it comes to author audits, some companies have put in place author agreements that describe their working relationship with authors. They have created databases for author disclosure and author sign-off sheets that ask authors to acknowledge that they have seen all the data and have contributed substantially to the publication. When companies are discussing strategy and plans, the advice is not to document ‘author to be determined’ in relation to any specific publication concepts. It is increasingly common for steering committees and publication advisory councils working across disease areas to be involved in publication planning.

The education and training of authors is equally important. Clarity and understanding of the publications role, policy and standards is essential, and furthermore supports the transparent partnership integral to the profession. Situations in which university authors are unable to be involved in authoring review articles if a third-party writer is used and if any funding is provided by industry are less likely to occur when the right policies, training and education are in place.

Audit is a good thing

By way of guidance, the publications professional may wish to look for, monitor and be prepared to respond to, 10 considerations (see Table 6).

Snyder concluded his talk by suggesting that companies and publications professionals should consider auditing themselves as a sound preparation for any future external audit.

Balancing the value and perceived bias inherent in review articles

As a stakeholder in the publications industry, medical journals are interested in the context of the scrutiny of the relationship between medicine and the pharmaceutical industry. The issue of competing interests remains an area of significant controversy and if they are to achieve the status of a ‘trusted source of information’, disclosure is almost a panacea. As with an auditor, there are things a journal wants to know. Whose idea was it? Who did what (authors, contributors)? Who funded it? What was the journal’s role and are there any conflicts of interest?

Tony Delamothe (BMJ) shared journal insights in a talk balancing the value and perceived bias inherent in review articles. He described how journals are keen to establish provenance and peer-review history, with no ambiguity about authorship or contributorship. Authors submitting or offering unsolicited reviews and editorials to the BMJ on potentially commercial topics are asked three questions:

1. Has anyone (particularly a company or public relations agency) prompted or paid you to write this article?

2. Would/did a professional writer contribute to the article, and to what extent?

3. Would the article be original, or would it be similar to articles submitted or published elsewhere?

Even if the answers to all three questions were ‘yes’, however, BMJ wouldn’t necessarily reject the proposal or article, as the journal appreciates that companies can commission some excellent evidence-based work, and that professional writers can present that evidence in a particularly readable

ACTIO

N PHAS

E IM

PROV

EMEN

T PHASE DEVELOPMENT PHASE

ADOPTION PHASE

Refine

Retrain

Adjustprocess

Understandexternal

influencesApply

internalconsiderations

Establishpolicy

Communicatepolicy

Train onpolicy

Assessadherenceto policy

Trackpolicy criteria

Reporting

Auditprocess

Fig. 3. The audit lifecycle. Reproduced with permission from Gene Snyder (UBC‑Envision Group).


and clear way that benefits readers and learners. The expectation, however, would be that the contributions of the companies and writers are mentioned in the article.

The ICMJE is currently trialing a unified approach to disclosures whereby the author needs only to complete one disclosure that is submitted to each journal complying with the ICMJE guidelines. But is disclosure enough, asked Delamothe, or are journals now part of a name-and-shame game using incorrect disclosure as a tool for retribution? Recently, an author who failed to make complete financial disclosures in three publications, an editorial, an article and a letter, was publicly named and shamed by JAMA, who published his letter in which he acknowledged how he had misinterpreted the journal’s requirements (Table 7).

Finally, Delamothe stated that although the percentage of journals publishing articles written by ghostwriters has fallen over the past few years, the number of guest authors has actually increased. The fact remains that not all journals require contribution to an article to qualify for authorship.

What makes an efficient, effective relationship? A medical communications agency perspective

Neil Matheson (Huntsworth Health) took a somewhat provocative approach when considering the relationship beween agency and client within the context of GPP. As a member of the ISMPP Issues and Actions Committee and an author of a GPP guide aimed at medical communications agencies,18 he is well placed to reflect on the good and the not so good aspects of the client/agency relationship.

What are the characteristics of a good medical communications agency and what is its role? A medical communications agency should demonstrate/have in place:

• a strategic perspective

• a thorough knowledge of regulatory issues

• a GPP policy

• an ability to create appropriate author relationships

• scientific/clinical expertise

• therapeutic area expertise

• writing talent

• professionalism

• discipline

• access to resources

• a good track record.

Monitor this: Take a look at this: To be prepared to respond to this:Authorship When are the authors identified? Ghostwriting, ghost authorship; accountability

Authorship agreements Author contracts, final approval of submitted document

Author participation

Company transparency Disclosure Funding and internal author affiliations clearly identified

Adherence to FDAAA disclosure policy

Are you publishing before disclosing and disclosing before 12 months after last patient last visit?

Accusations that you are withholding data

Redundant publishing Overzealous repurposing of the same information Salami slicing (Note – encore is okay within reason and for good purpose)

Version participation Author participation This was not ghostwritten

Financial commitment What did we pay for and how much? Justification of payment for work completed

Investigator-sponsored research Are the studies we sponsor getting published? What has your role been in the development of publications of investigator-sponsored research?

How has marketing been involved? Like it or not, marketing is generally persona non-grata in audit situations

Implications that marketing inappropriately influenced development of a manuscript

Agency participation What role is the agency playing in the development of documents; is it consistent with your policy? Are they skipping steps, documenting appropriately, etc.?

You pay third-party writers to do your work; buying their time to write positive manuscripts

Table 6. Ten considerations that publications professionals may wish to look for, monitor and be prepared to respond to. Reproduced with permission from Gene Snyder (UBC‑Envision Group).

“I would like to report incomplete financial disclosures related to an Editorial,....a Clinical Crossroads article,...and a subsequent reply to a letter to the editor...published in JAMA. This resulted from my misinterpretation of JAMA requirements for reporting conflicts of interest...”

Table 7. Letter published in JAMA 2010.17


Are such agencies a strategic partner, an advisor or publication planner, a provider of editorial and medical writing support or a member of a publications steering committee? Or are they all those things? What exactly are the client’s expectations and what is the reality surrounding the role of the agency with respect to the functionality of the client publication team?

Huntsworth Health encounters a broad spectrum of publication teams. Some are dysfunctional, with no common sense of purpose and a lack of commitment to achieving a common goal. The biggest problems usually stem from the perceived ownership of the clinical data. There is often a lack of agreement as to who ultimately determines the way in which the data are presented. Questions such as ‘Can we really say this?’ ‘Do the data support this?’ and ‘Is this an accurate statement?’ are commonplace during internal review, and the publications agency partner is not the appropriate decision-maker. There must be a clear and effective process for managing the review process to ensure that GPP is implemented.

The second biggest problem is the frustration arising from a divergence in what the membership of the publication team thinks it is doing versus the reality of what it is actually doing. Clear concise and timely communication between client and vendor via a key point of contact is essential.

The mismatch in expectations means it can and sometimes does all go wrong. Does the following scenario sound familiar? The outline of a manuscript is agreed with the author in an appropriate way and the first draft is created. In the meantime new data are published that have an impact on the way the data should be presented. The agency reaches out to the author to determine the changes required, resulting in a revision to the original draft, and the client sets about deciding internally how best to move forward strategically. The agency is now placed in a position of arbitrating between the parties – the client owns the data and the author is responsible for disseminating it in an appropriate, scientifically credible manner.

The friction between those who ‘own’ the data and those who disseminate

the data can be significant

The friction between those who ‘own’ the data and those who disseminate the data can be significant. Sometimes an agency is briefed before the client’s publications professional has gained internal consensus on a number of issues relating to the data and their presentation. When the first draft of the manuscript is not as per the publication team’s expectations, the agency is sometimes used as the scapegoat. This impacts timelines and budget, and creates yet another source of friction – between the various client team members and the agency – impacting the partnership dynamic.

Surprisingly, clients have misconceptions about the agency’s ability to influence journal acceptance, make a ‘silk purse’ from a ‘sow’s ear’ or polish something that is dull and get it to shine. There are also frequent misconceptions about turning around revisions overnight, or writing and submitting an abstract the day before the deadline.

Conversely, it is important for companies to ask seemingly difficult questions about the medical communications agencies they are considering hiring. One such question might be, ‘what is the agency’s retention policy for documents?’

When a pharmaceutical company is subpoenaed, the agency is subpoenaed as well. The US Attorney’s office will ask for an exhaustive list of documents relating to the issue being investigated. The agency must be prepared to respond effectively as a party to the investigation of it’s client by providing a clean publication planning paper trail. This can be an expensive process, with costs ranging from $50,000 to $80,000 for copying, consecutive numbering and compiling the submission documents. Matheson stated that hiring a good lawyer who asks the right questions can be invaluable in helping to reduce the costs and amount of work involved in responding to these subpoenas.

Clients are urged to define their expectations, specify team roles and responsibilities, define who is calling the shots, stick to the disciplined internal review process, communicate and trust each other.

In a business that is under fire from many angles we, as professionals working together, must make trust the foundation of the client/agency relationship.

Authors’ perspectives on the changing landscape

In view of how some universities and academic institutions are re-evaluating their disclosure policies for authors who collaborate with the pharmaceutical industry, it is prudent to listen to the authors’ perspective on the changing landscape. A moderated discussion between Larry Danziger (University of Illinois at Chicago and College of Pharmacy), Jay Goldstein (University of Illinois at Chicago) and Michael Becker (University of Chicago) was led by Elizabeth Crane (Astellas Pharma).

Crane opened the session by asking the authors to describe their experiences of working with the pharmaceutical industry. Having collaborated with industry on research projects as well as publications, all three authors were of the opinion that, on the whole, their interactions with industry have been good, but not entirely so. Goldstein’s view was that the publication of a clinical trial is the beginning of a dialogue not the end. These sentiments were echoed during the ensuing discussion and the panel concurred that the industry should just present


the data, don’t explain them, over-explain them or over-present them.

The consensus of opinion was that when authoring a publication the experts want to see all the data, both positive and negative. They want to conduct their own due diligence and formulate their opinions before entering into discussions with industry. The panelists had different approaches to writing a publication: some write everything themselves, others involve colleagues and others accept the support provided by a medical communications agency or freelance writer. Although the panelists expressed different preferences, they shared a common clear view about taking ownership and accountability for the clinical trials they are involved with and the publications they author.

The panelists viewed their relationship with industry as a positive partnership

and welcomed the move toward increased transparency

The panel was aware that the publications industry is under increased scrutiny. They expressed a basic awareness of the changing environment involving authorship, transparency and disclosure. The consensus of opinion was that they would like pharmaceutical companies to inform them upfront of all required disclosures as well as the format of all intended data presentations. They are aware of the desire for clinical trial posting to be aligned with the publication of results, and advocate an improvement in the contextual format of the posting to facilitate this. As experts they need to balance their roles as consultants, investigators and authors, manage their conflicts and limit the number of hats worn at any one time. Overall, the panelists viewed their relationship with industry as a positive partnership and welcomed the move toward increased transparency.

Conclusion

Maureen Garrity wrapped up the TIPPA 2010 Midwest Meeting by saying that, despite a degree of overlap between TIPPA and ISMPP, delegates appeared infinitely eager to continue to engage with each other and share best practice. As advocates for the publications profession, the unanimous aim of the audience was to continually improve and find better ways to approach novel challenges that will have a positive impact on how well the publications industry is perceived. The closing remarks acted as a ‘rallying call’ encouraging delegates to go out and confront the challenges head on. Progress will, of course, be collectively evaluated at TIPPA 2011.

References

1. International Committee of Medical Journal Editors. Uniform requirements for submission of manuscripts to biomedical journals, 2003. Available at icmje.org

2. Wager E, Field EA, Grossman L. Good publication practice for pharmaceutical companies. Curr Med Res Opin 2003;19:149–54.

3. Graf C, Battisti WP, Bridges D, et al. Research methods & reporting. Good publication practice for communicating company sponsored medical research: the GPP2 guidelines. BMJ 2009;339:b4330.

4. Jacobs A, Wager E. European Medical Writers Association (EMWA) guidelines on the role of medical writers in developing peer-reviewed publications. Curr Med Res Opin 2005;21:317-22.

5. WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. Available at wma.net/en/30publications/10policies/b3/index.html

6. Pharmaceutical Research and Manufacturers of America. Principles on communication of clinical trial results, 2002. Available at phrma.org

7. American Medical Writers Association (AMWA). AMWA Position Statement on the Contribution of Medical Writers to Scientific Publications. Available at amwa.org

8. Gøtzsche PC, Kassirer JP, Woolley KL, et al. What should be done to tackle ghostwriting in the medical literature? PLoS Med 2009;6:e23.

9. Wager E, Fiack S, Graf C, et al. Science journal editors’ views on publication ethics: results of an international survey. J Med Ethics 2009;35:348–53.

10. Institute of Medicine of the National Academies. Conflict of interest in medical research, education, and practice, 2009. Available at iom.edu/conflictofinterest

11. Harding A. Researchers call for ban on pharma ads in medical journals. The New York Times 15 May 2006.

12. Tierney J. Corporate backing for research? Get over it. The New York Times 26 January 2010.

13. Mathews AW. At medical journals, paid writers play big role. The Wall Street Journal 13 December 2005.

14. Wislar J, Flanagin A, Fontanarosa PB, et al. Prevalence of honorary and ghost authorship in 6 general medical journals, 2008. Available at ama-assn.org/public/peer/abstracts_2009.html#7

15. Hamilton C. Presented at the 2009 AMWA Conference, 22–24 October 2009, Dallas, Texas, USA.

16. US Food and Drug Administration. Good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses of approved drugs and approved or cleared medical devices, 2009. Available at fda.gov/oc/op/goodreprint.html

17. Whitley RJ. Incomplete financial disclosures in an Editorial, Clinical Crossroads, and Reply Letter related to herpes zoster. JAMA 2010;303(8):(doi:10.1001/jama.2010.109).

18. Bareket-Samish A, Denny M, Ruzicka B, et al. Good publication practice guidelines for medical communications agencies: a MedComm perspective. Curr Med Res Opin 2009;25:453–61.

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The International Publication Planning Association’s 7th Annual MeetingA KeywordPharma Conference Insights review by Elizabeth Wager Published September 2009

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An in-depth report from the 7th Annual Meeting of the International Publication Planning Association (TIPPA) held in San Francisco, CA, USA, 15–16 June 2009

Executive Summary

The reputation of publication planners continues to require defence against accusations of ghostwriting and ghost management. Demands for increased transparency remain prevalent, while the age-old issue of industry sponsorship still provokes unwarranted prejudice. Companies are responding positively, with the introduction of new policies on the disclosure of results and an increased focus on compliance. However, this has, in turn, led to a diverse range of guidelines and new challenges for publication planners in interpreting them. The emergence of online communication channels such as blogs, which can often contain misinformation or imbalanced commentary, lends new complications for company communication strategies.

The International Publication Planning Association’s 7th Annual Meeting, covered in depth in this Conference Insights review, looked at the regulatory, ethical and operational challenges in publication planning, and presented an industry in transition. Beginning with an overview of the evolving regulatory frameworks for trial registration and results disclosure, and their impact on publication planning, professionals shared insights into how the industry is responding and what more can be done to enhance its reputation among health professionals and journal editors.

The meeting also explored critical issues such as risk mitigation, budget management and the issues of authorship and developments in health economic and outcomes research from the perspectives of journal editors, publication planning professionals and medical communications experts.

Contents

• Programme• About the author• Current challenges in publication planning• The FDA Amendments Act• Risk mitigation in publication planning• Doing more with less• Coping with a global organisation• Clinical trial disclosure requirements• Generating and communicating economic and

humanistic value to payers and decision makers• Editors’ panel

• Senate Finance Committee inquiries• GPP and GPP2• Tackling the authorship debate• Reprints and supplements• Publication and reporting bias• Firewalls: responding to the current regulatory

environment• The TIPPA member survey• Conclusions• References

About the author

Elizabeth (Liz) Wager is the author of books on ‘Getting Research Published: An A to Z of Publication Strategy’ and ‘How to Survive Peer Review’. She is a co-author of ‘Good Publication Practice For Pharmaceutical Companies’ and the European Medical Writers Association’s guidelines on the role of medical writers.

After obtaining a first-class zoology degree from Oxford in 1983, she worked for Blackwell Scientific Publications, Janssen-Cilag then Glaxo-Wellcome. In 2001, she set up her own company, Sideview, which provides training, writing, editing and publication consultancy services. Since going freelance, Liz has run courses on publication strategy, medical writing and publication ethics on five continents.

She is the Chair of COPE (the Committee on Publication Ethics) and a member of: the BMJ’s Ethics Committee, the World Association of Medical Editors Ethics Committee and the World Health Organization Scientific Advisory Group on trial registration. She is also a Visiting Fellow at the UK Cochrane Centre.

She can be contacted at: [email protected] or via www.lizwager.com

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