A Defense of Professional Medical Writers 2

Updated on February 16 with a response by Tom Yates to Karen Woolley.

Editor’s Note: In response to a recent guest post by Tom Yates on industry sponsored editorial assistance, the following comment was submitted  by Karen Woolley on behalf of the Global Alliance of Publication Professionals. This thoughtful statement deserves attention, but I would point out that Woolley does not actually address the problems raised by Yates about industry sponsorship of articles. Specifically, I would invite Woolley and her group to respond to these questions posed by Yates:

  • What expertise do publications professionals have have in the field about which they are writing?
  • Can Woolley point to industry-sponsored publications that do  not recommend prescribing a drug manufactured by the sponsor?
  • Will the industry sponsor or the communications company make public the details of their contract?

Disclosure is necessary, but not sufficient, when it comes to ethical medical writing assistance

As professional medical writers (NOT ghostwriters!) we read the guest post from Mr Tom Yates with much interest. We believe that disclosure of medical writing assistance, whether funded from non-commercial or commercial sources, is necessary, but not sufficient, when it comes to ethical medical writing assistance. The practices that professional medical writers follow involve far more than just disclosure!

In this regard, the freely available “anti-ghostwriting” checklist (1) may be of particular interest to Mr Yates and your readers. When authors sign and submit this checklist, they agree that the writer(s) they used can, if requested by a journal editor, “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).”

The World Association of Medical Editors states that ‘‘editors should make clear in their journal’s information for authors that medical writers can be legitimate contributors.’’ Evidence is now showing that medical writers are legitimate AND valuable contributors. Manuscripts prepared with professional medical writing assistance are rarely retracted for misconduct (2), are more compliant with CONSORT guidelines (3) and are accepted more quickly for publication (4).

Mr Yates raises particular concerns about review articles. As professional medical writers, we assist authors with the often long and laborious effort required to write a review that complies with best practice reporting guidelines (eg, PRISMA). The authors we assist are experts in their field and may receive industry support. We help ensure that financial conflicts of interest are disclosed in a complete and transparent manner. Mr Yates’ proposed solution of banning review articles authored by those with ANY financial conflicts of interest has been tried… and it failed. Indeed, the highly respected New England Journal of Medicine had to change this “blanket ban” policy (5). The editors explained that “…our ability to provide comprehensive, up-to-date information, especially on recent advances in therapeutics, has been constrained.” The current policy states that “…because the essence of reviews and editorials is selection and interpretation of the literature, the Journal expects that authors of such articles will not have any significant [our emphasis] financial interest in a company (or its competitor) that makes a product discussed in the article.”

If we want clinicians to have access to timely and high-quality publications from commercial or non-commercial research, then professional medical writers are part of the solution, not the problem.

Professor Karen Woolley

On behalf of fellow GAPP members Dr Cindy Hamilton, Dr Adam Jacobs, Art Gertel, and Gene Snyder (www.gappteam.org).

Disclosures: All GAPP members have or do hold leadership roles at associations representing professional medical writers (eg, AMWA, EMWA, DIA, ISMPP, ARCS), but do not speak on behalf of those organizations. GAPP members have or do provide professional medical writing services to not-for-profit and for-profit clients.

1. Gøtzsche PC et al. PLoS Med 2009;6(2):e1000023.

2. Woolley KL et al. Curr Med Res Opin 2011;27:1175-1182

3. Jacobs A. Write Stuff 2010;19:196-200

4. Bailey M. AMWA Journal 2011;26:147-152

5. Drazen JM, Curfman GD. NEJM 2002;346:1901-1902

Update (February 16): Tom Yates sent the following response to Woolley’s statement above:

As CEO of a company that makes profit providing medical writing
services to drugs companies, Karen Woolley is poorly placed to give a
balanced account of the evidence around industry involvement in the
writing of review articles. Her comment on my blog [1] is a prime
example of the problem I sought to highlight.

A lot of the points Woolley makes are extraneous. The CONSORT
statement [2, 3] relates to the reporting of randomised controlled
trials rather than review articles and only demands that that funding
of the trial be reported. As I explained in my letter to QJM [4], the
evidence that disclosure offers any protection against funder bias is
mixed. The PRISMA statement [5], again, only demands disclosure of the
funders of the systematic review. I addressed the issue of inadequate
protection against funder bias in systematic reviews in a recent blog
article [6].

The suggestion that the NEJM policy of banning review articles from
conflicted authors ‘failed’ [1] is misleading. The policy stood for
more a decade and former editor Jerome Kassirer describes in his book
[7] chilling examples of the biased review articles it offered some
protection against.

The editor who relaxed the policy, Jeffrey Drazen, stated ‘We would
prefer that therapeutic research not be funded directly by commercial
entities, but we are not the decision makers in this matter.’ [8] His
was a compromise between ease of/ability to source review articles and
funder bias. Drazen’s decision to relax the rule [9] was controversial
with opposition from former editors [7, 10].

In my blog [4], I highlighted Amy Wang’s paper on funder bias in
review articles relating to the Rosiglitazone controversy [11].
Another good example of funder bias in review articles is the
literature on the safety of calcium channel antagonists [12]. My take
on the NEJM policy is, given the potential harm caused by biased
review articles, I would rather see fewer review articles that I can
trust.

These issues are distinct from those I initially raised [4]. Whilst,
tragically, my profession may be so riddled with conflicts of interest
that it is a challenge to source review articles on particular topics
from independent authorities, most of us are capable of stringing a
few sentences together without help from an industry funded assistant.
That we tolerate industry sponsored editorial assistance is shameful.

1. Woolley K. Disclosure is necessary, but not sufficient, when it
comes to ethical medical writing assistance. In: A Defense of
Professional Medical Writers, Cardiobrief, 14 February 2012. Available
from http://cardiobrief.org/2012/02/14/a-defense-of-professional-medical-writers
(accessed 16 February 2012).
2. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux
PJ, Elbourne D, Egger M, Altman DG, for the CONSORT Group. CONSORT
2010 Explanation and Elaboration: updated guidelines for reporting
parallel group randomised trial. BMJ 2010; 340: c869.
3. Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010
Statement: updated guidelines for reporting parallel group randomised
trials. BMJ 2010; 340: c332.
4. Yates TA. Industry Sponsored Editorial Assistance. Sick Populations
blog, 12 February 2012. Available from
http://sickpopulations.wordpress.com/2012/02/12/industry-sponsored-editorial-assistance
(accessed 16 February 2012).
5. Moher D, Liberati A, Tetzlaff J, Altman DG, for the PRISMA Group.
Preferred reporting items for systematic reviews and meta-analyses:
the PRISMA statement. BMJ 2009; 339: b2535.
6. Yates TA. Separate analysis of independent and industry supported
studies would be informative. Sick Populations blog, 4 January 2012.
Available from http://sickpopulations.wordpress.com/2012/01/04/cochrane_reviews
(accessed 16 February 2012).
7. Kassirer JP. On the take. New York: Oxford University Press, 2005.
8. Drazen JM, Curfman GD. Financial associations of authors. N Engl J
Med 2002; 347: 1043-1044.
9. Drazen JM, Curfman GD. Financial associations of authors. N Engl J
Med 2002; 346: 1901-1902.
10. Relman AS. Financial Associations of Authors. N Engl J Med 2002;
347: 1043-1044.
11. Wang AT, McCoy CP, Murad MH, Montori VM. Association between
industry affiliation and position on cardiovascular risk with
rosiglitazone: cross sectional systematic review. BMJ 2010; 340:
c1344.
12. Stelfox HT, Chua G, O’Rourke K, Detsky AS. Conflict of Interest in
the Debate over Calcium-Channel Antagonists. N Engl J Med 1998; 338:
101-106.

Editor’s note: The debate over this topic continues here.

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2 comments

  1. Dear Editor,

    Although the Global Alliance of Publication Professionals (GAPP) cannot answer the questions that Mr Yates posed directly to Isabelle Leach and PAREXEL, we welcome the opportunity to answer the questions you have asked.
    1. What expertise do publications professionals have in the field about which they are writing?
    This question provides a great platform to identify the expertise that professional medical writers do and (typically)* do not bring the publication process. Professional medical writers have scientific communication expertise; the authors have therapeutic area expertise. These areas of expertise complement each other. Is it helpful for a medical writer to be familiar with the therapeutic area? Yes. Is it necessary? No. The authors take full responsibility for the content;* the medical writer’s role is to ensure that content is communicated in a timely and compliant manner. The situation with professional medical writers is analogous to the situation with statisticians. Statisticians do not need to be therapeutic area experts – the authors do. Statisticians need to excel at their job; so, too, do medical writers. Manuscripts are often a team effort and, increasingly, professional medical writers are part of the manuscript team.

    Notably, the international competency model for professional medical writers does not list the need for therapeutic area expertise, but it does include a long list of competencies for scientific communication (eg, knowledge of regulatory, publication, and style guidelines; English language skills; computer skills, project management skills; attention-to-detail etc…).1

    * If a professional medical writer does have recognized expertise in a therapeutic area (eg, worked as a clinician in that area or completed their PhD or post-doctoral studies on the topic) or was instrumental in data collection (eg, for a systematic review manuscript), the writer may meet the criteria for authorship. If so, the medical writer should be listed as an author.

    2. Can Woolley point to industry-sponsored publications that do not recommend prescribing a drug manufactured by the sponsor?
    Yes. The following papers do not recommend prescribing a drug manufactured by the sponsor. Please note that these papers were identified through a quick search of MEDLINE – a proper search of the literature would no doubt identify others.

    http://www.hindawi.com/journals/prt/2011/239501/
    http://bja.oxfordjournals.org/content/103/4/576.full
    http://onlinelibrary.wiley.com/doi/10.1002/cncr.25639/full
    http://jco.ascopubs.org/content/27/5/672.long
    http://www.ncbi.nlm.nih.gov/pubmed/17909804 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2442407/?tool=pubmed

    At a broader level, your question relates to the publication of “negative” trials. The Joint Position Statement from the International Federation of Pharmaceutical & Manufacturers Associations (to which most large pharmaceutical companies belong) directly addresses the issue of negative trials.2 The Statement should be read in full, but we have included a relevant extract below:
    All industry-sponsored3 clinical trials4 should be considered for publication in the scientific literature irrespective of whether the results of the sponsors’ medicine(s) are positive or negative. At a minimum, results from all phase 35 clinical trials and any clinical trial results of significant medical importance should be submitted for publication. This includes investigational clinical products whose development programs are discontinued.
    Industry sponsors are well aware of the need to develop medicines that actually help patients and represent true value to the healthcare system (the “carrot” to do the right thing). Industry sponsors are also well aware of the threat of litigation should one of their employees or contractors do the wrong thing (the “stick” to do the right thing). No industry is without its “bad apples”. Anyone who knowingly pushes inappropriate prescribing faces the threat of fines and litigation – not to mention the lifelong guilt of hurting patients (if these type of people feel such guilt). No professional medical writer wants to work with industry or academic authors who want to publish misleading research. Indeed, the questions that professional medical writers ask and the fact checking they do may dissuade these types of authors from working with professional medical writers. Perhaps this is one of the reasons that papers with disclosed professional medical writing support are rarely retracted from the literature because of misconduct.3

    3. Will the industry sponsor or the communications company make public the details of their contract?
    In the same way that sponsors and authors do not make public the details of their contracts with statisticians, lab assistants, technical support staff etc… sponsors and authors do not make public the details of their contracts with professional medical writers.

    At a very practical level, nobody within GAPP (and collectively we have more than 100 years of experience) has ever come across or signed a contract that includes any clause that requires the medical writer to comply with the sponsor’s wishes – right or wrong; nor have we ever seen any punitive clauses that prevent a medical writer from expressing disagreement.

    Given concerns about “arrangements” between sponsors and authors, it is also worth highlighting the efforts made by advocates of ethical publication practices (including editors, publishers, sponsor employees, and professional medical writers), to develop guidelines that clearly stipulate the roles and responsibilities of publication team members (eg, sponsors, authors, writers). These guidelines were published in the BMJ in 2009.4 Your readers may be most interested in the responsibilities of sponsors and authors (extract below). Authors, as is right and proper, have the most responsibilities when it comes to a manuscript.

    Sponsors

    • Grant authors full access to study data
    • Confirm the authors’ freedom to make public or publish the study results
    • Provide authors with copies of the sponsor’s publication policy.

    Authors

    • Plan and produce articles or presentations that are accurate and complete in a timely manner
    • Avoid premature publication or release of study information
    • Avoid duplicate publication
    • Make decisions about practical issues concerning presentation and publication (for example, choice of congress or journal)
    • Disclose potential conflicts of interest in all articles and presentations
    • Identify funding sources in all articles and presentations
    • Ensure authorship is attributed appropriately
    • Acknowledge in all articles and presentations all significant contributions made by individuals and organisations
    `• Provide the sponsor with copies of publication policies from the authors’ institutions

    We hope these comments from GAPP provide you and your readers with additional insight into the role of a professional medical writer and the environment in which we work. Thank you for your questions.

    Professor Karen Woolley
    On behalf of fellow GAPP members Dr Cindy Hamilton, Dr Adam Jacobs, Art Gertel, and Gene Snyder (www.gappteam.org).

    Disclosures: All GAPP members have or do hold leadership roles at associations representing professional medical writers (eg, AMWA, EMWA, DIA, ISMPP, ARCS), but do not speak on behalf of those organizations. GAPP members have or do provide professional medical writing services to not-for-profit and for-profit clients.

    References
    1. Woolley KL, Clemow D. Development and practical use of a medical writer competency model. DIA Global Forum 2010;2:8-11.
    2. Joint Position on the Publication of Clinical Trial Results in the Scientific Literature; http://clinicaltrials.ifpma.org/clinicaltrials/fileadmin/files/pdfs/20100610_Joint_Position_Publication_10Jun2010.pdf (accessed 15 February 2011)
    3. Woolley KL, Lew RA, Stretton S, et al. Lack of involvement of medical writers and the pharmaceutical industry in publications retracted for misconduct: a systematic, controlled, retrospective study. Curr Med Res Opin 2011;27:1175-1182
    4. 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

  2. Pingback: Industry Supported Editorial Assistance: The Debate Continues « CardioBrief

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