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Response from the International Society for Medical Publication Professionals (ISMPP)
Posted by plosmedicine on 31 Mar 2009 at 00:15 GMT
Author: Larry Hirsch
Additional Authors: Gene P. Snyder – President-Elect, ISMPP
Submitted Date: November 02, 2007
Published Date: November 5, 2007
This comment was originally posted as a “Reader Response” on the publication date indicated above. All Reader Responses are now available as comments.
We wish to correct the misperceptions of ISMPP resulting from the commentary by Dr. Sismondo(1), and address some other issues. Founded 3 years ago, ISMPP is a 501(c)(6) non-profit organization, whose mission is to educate members on best practices in medical publication. Speakers in our programs have included bioethicists, chaired academic professors, ICMJE editors, AAMC officials, and other critics of industry such as Dr. Aubrey Blumsohn, all of whom vigorously debate controversial issues(3). We would welcome Dr. Sismondo to attend our meeting next April. With increasing technical and prescriptive demands for “transparency” and short publication time frames, responsible medical writing support and publication planning benefit medical publications. ISMPP unambiguously supports full disclosure of medical writing assistance and funding for such support, when applicable(2). We recommend use of the contributorship model to clarify roles of all participants in preparation of medical publications. However, disclosure and acknowledgment of writing support when the named authors do not control manuscript content violates the letter and spirit of authorship criteria. The ISMPP Code of Ethics calls on our members to provide accurate, complete, and balanced reporting of clinical trials-named authors are responsible for the content of any manuscript on which an ISMPP member might provide assistance.
Sismondo’s depiction of the manipulation of peer-reviewed publication with pharmaceutical-controlled ghost-writing, guest authoring, etc. rehashes previous anti-industry critiques(5-6). These are problems of industry-sponsored research, he argues, but apparently accepts and excuses questionable authorship practices common within academic, non-commercial research such as inclusion of senior professors/department chairs as honorary authors(1). We contend honorary or guest authorship violate the basic tenets of authorship promulgated by the ICMJE(7).
“Ghost authors” can be either voluntary (knowing they won’t be named) or involuntary (a deserving contributor is removed for reasons including hierarchy, politics and appearance). Sismondo argues that the latter is common in industry-sponsored trials(1). In fact, it is common throughout academic medicine(8). There are strong biases against clinical manuscripts with industry funding or analysis(9), so not surprisingly companies may limit (or prevent) naming their scientists as authors. ISMPP believes the practice of withholding deserving contributors as authors only perpetuates the negative perception of industry scientists (many of whom came from academia). However, change is unlikely(9) unless journal editors/reviewers treat manuscripts based on their content, not on authors’ affiliations - as advocated by the Council of Science Editors(10).
Sismondo writes that results of pharma-sponsored clinical research strongly favor the sponsoring company’s product(s), bias the published literature and that ghost management amplifies this(1). Is this bias, or an accurate reflection of medical product development? Companies predominantly fund trials (often placebo-controlled) with higher perceived likelihoods of success. Industry-sponsored trials are methodologically high quality(11) and, if positive and approved by regulators, may be used in product promotion. What is the alternative-Anecdote? Data on file? Perhaps no promotion at all? In reality, publication alone does not change medical practice, where under-diagnosis and use of evidence-based interventions is so common. Promotion is synergistic with peer-reviewed publication to improve physician prescribing(12). Even the N Engl J Med promotes purchases of published articles as “the most effective way to influence physician [prescribing] behavior”(13).
ISMPP remains committed to educating our members on the challenges of authorship and facilitating medical publication, while respecting generally-accepted standards and best practices for disclosure and for authorial control of manuscript content. This facilitates efficient and effective communication of clinical trial findings to prescribing physicians.
1. Sismondo S. (2007) Ghost Management: How much of the medical literature is shaped behind the scenes by the pharmaceutical industry? PLoS Medicine 4:1429-33.
2. International Society for Medical Publication Professionals (www.ismpp.org). Accessed on October 19, 2007.
3. Blumsohn A. (2006) Authorship, ghost-science, access to data, and control of the pharmaceutical scientific literature: Who stands behind the word? AAAS Professional Ethics Report 29:1-4.
4. Norris R, Bowman A., Fagan JM et al. (2007) International Society for Medical Publication Professionals (ISMPP) position statement: The role of the professional medical writer. Curr Med Res Opin 23:1837-40.
5. Moffat B, Elliott C. (2007) Ghost marketing: Pharmaceutical companies and ghostwritten journal articles. Perspect Biol Med 50:18-31.
6. Elliott C. (2004) Pharma goes to the laundry: Public relations and the business of medical education. Hastings Center Report 34:18-23.
7. International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to medical journals: Writing and editing for biomedical publication. Available: http://www.icmje.org/ Accessed October 15, 2007
8. Bhopal R, Rankin J, McColl E, et al. (1997) The vexed question of authorship: Views of researchers in a British medical faculty. BMJ 314:1009-13.
9. Rothman KJ and Evans S. (2005) Extra scrutiny for industry funded trials: JAMA’s demand for an additional hurdle is unfair-and absurd. BMJ 331:1350-51.
10. Scott-Lichter D, and the Editorial Policy Committee, Council of Science Editors. CSE’s White Paper on Promoting Integrity in Scientific Journal Publications. Reston, VA: CSE; 2006.
11. Lexchin J, Bero LA, Djulbegovic B, Clark O. (2003) Pharmaceutical industry sponsorship and research outcome and quality: Systematic review. BMJ 326:1167-70.
12. Majumdar SR, McAlister FA, Soumerai SB. (2003) Synergy between publication and promotion: Comparing adoption of new evidence in Canada and the United States. Amer J Med 115:467-72. 13.Sismondo S. Linking research and marketing, a pharmaceutical innovation. Page 6. http://post.queensu.ca/~s... Accessed October 18, 2007.