Medical ghostwriter

The American Medical Writers Association speaks to the topic as follows:^[1]

"Ghost authoring" refers to making substantial contributions without being identified as an author. "Guest authoring" refers to being named as an author without having made substantial contributions. "Ghostwriting" refers to assisting in presenting the author's work without being acknowledged. The term "ghostwriting" is often used to encompass all three of these practices.

With medical ghostwriting, professional writers and other parties are paid — commonly (but by no means always) by pharmaceuticals and medical devices manufacturers — to produce manuscripts for conference presentations, scientific publications, explicitly promotional distributions, patient education materials, continuing professional education activities' contents, and other communications. In the pharmaceuticals and medical devices industries, physicians and other scientists are frequently^{[citation needed]} permitted or paid to attach their names to these manuscripts, which are then promulgated at meetings, distributed to patients and caregivers, presented as marketing instruments, or published in textbooks and medical journals. These scientists or physicians may have little involvement in the research or the writing process.^[2]

Criticism

Medical ghostwriting has been criticized by a variety of professional organizations^[3][4] representing the drug industry, publishers, and medical societies, and it may violate American laws prohibiting off-label promotion by drug manufacturers as well as anti-kickback provisions within the statutes governing Medicare.^[5] Recently, it has attracted scrutiny from the lay press^[6][7] lawmakers^[8] the Institute of Medicine,^[9] and the National Institutes of Health.^[10] as well. It is permitted at some institutions, including the University of Washington School of Medicine,^[11][12] while it is prohibited and considered a particularly pernicious form of plagiarism at others, such as Tufts University School of Medicine and the University of Pennsylvania School of Medicine.^[13][14]

Scandals involving prominent physicians researchers have been reported at over a dozen universities in the United States, however, there have been no reports of any professors being disciplined.^[15]. Professor Trudo Lemmens of the University of Toronto School of Law argues that ghostwritten papers help protect companies when they are sued in court.^[16]

Professional medical writers can write papers without being listed as authors of the paper and without being considered ghostwriters, provided their role is acknowledged. The European Medical Writers Association have published guidelines which aim to ensure professional medical writers carry out this role in an ethical and responsible manner.^[17] The use of properly acknowledged medical writers is accepted as legitimate by organisations such as the World Association of Medical Editors^[3] and the British Medical Journal^[18]. Moreover, professional medical writers' expertise in presenting scientific data may be of benefit in producing better quality papers.^[19]

Prevalence

It is difficult to determine how frequently ghostwriting occurs due to its covert nature. A 2009 New York Times article estimated that 11% of New England Journal of Medicine articles, 8% of JAMA, Lancet and PLoS Medicine articles, 5% of Annals of Internal Medicine articles and 2% of Nature Medicine were ghost written.^[20] Between 1998 and 2005 Wyeth had 26 papers promoting hormone replacement therapy (HRT) published in scientific journals.^[21] Previously secret internal Wyeth documents providing evidence of this are viewable on the Drug Industry Document Archive. It also appears to have occurred in 75% of industry funded trials between 1994 - 1995 approved by the Scientific Ethical Committees for Copenhagen and Frederiksberg.^[2] Of the articles published from 1998 to 2000 regarding sertraline, between 18% and 40% were ghost written by Pfizer.^[2] A questionnaire using comparable methods in 2005 and 2008 with a 14-28 % response rate found a decrease in number of people who reported ghostwriting among professional medical writers.^[22]

Most pharmaceutical companies have in-house publication managers who may either manage the writing of publications on the company's drugs by a team of in-house medical writers or contract them out to medical communication companies or freelance medical writers. Reprints of the articles can be distributed to doctors in their offices or at medical meetings by drug company representatives in lieu of product brochures. This practice might be illegal if it effectively constitutes advertising or advocating use of the drug for non-approved indications or dosages. Payments to medical ghostwriters may be augmented with consulting contracts, paid trips to teach continuing medical education courses, or grants. The academics or doctors are known as "KOLs" ("Key Opinion Leaders") or "TLs" ("Thought Leaders").^{[citation needed]}

Senate Investigation of Medical Ghost Writing

On June 24, 2010, Senator Charles E. Grassley, Ranking Member of the United States Senate Committee on Finance issued a report on medical ghost writing. The report said, "The Committee was provided with documents from recent lawsuits involving Wyeth’s hormone therapy products. The documents showed that Wyeth hired a medical communications and education company, DesignWrite Inc. (DesignWrite), to draft review articles regarding the breast cancer risk of hormone therapy products and then invited academic researchers to sign on as the primary authors."^[23]

References

1. ^ AMWA Ethics FAQs, Publication Practices of Particular Concern to Medical Communicators"[1]
2. ^ ^{a b c} Sismondo S (September 2007). "Ghost management: how much of the medical literature is shaped behind the scenes by the pharmaceutical industry?". PLoS Med. 4 (9): e286. doi:10.1371/journal.pmed.0040286. PMC 1989751. PMID 17896859. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=1989751. 
3. ^ ^{a b} World Association of Medical Editors (2005) Ghost writing initiated by commercial companies. J Gen Intern Med 20: 549 (also available athttp://www.wame.org/resources/policies#ghost)
4. ^ Rennie D, Flanagin A (1994) Authorship! Authorship! Guests, ghosts, grafters, and the two-sided coin. Jama 271: 469-471.
5. ^ Studdert et al., (2004) Financial Conflicts of Interest in Physicians' Relationships with the Pharmaceutical Industry — Self-Regulation in the Shadow of Federal Prosecution, NEJM 351:1891-2000
6. ^ Mathews, "At medical journals, paid writers play big role", Wall Street Journal December 13, 2005
7. ^ Elliot Ross, "How drug companies' PR tactics skew the presentation of medical research", Guardian 20 May, 2000 http://www.guardian.co.uk/science/2011/may/20/drug-companies-ghost-writing-journalism
8. ^ House of Commons Health Committee (2005) The influence of the pharmaceutical industry. London: The Stationery Office Limited.
9. ^ Project On Government Oversight, "Frequently Asked Questions about Medical Ghostwriting", June 28, 2011 http://www.pogo.org/pogo-files/alerts/public-health/ph-iis-20110620.html
10. ^ Project On Government Oversight, "Frequently Asked Questions about Medical Ghostwriting", June 28, 2011
11. ^ Boseley, the Guardian, February 7, 1992
12. ^ Giombetti, 1992, "UW's Friendly Corporate Ghostwriter", Eat the State Vol. 6, No. 19
13. ^ Krimsky, Science in the Private Interest, Rowman-Littlefield Publishing Co., 2003
14. ^ Project On Government Oversight, "Frequently Asked Questions about Medical Ghostwriting", June 28, 2011 http://www.pogo.org/pogo-files/alerts/public-health/ph-iis-20110620.html
15. ^ Project On Government Oversight, "Frequently Asked Questions about Medical Ghostwriting", June 28, 2011 http://www.pogo.org/pogo-files/alerts/public-health/ph-iis-20110620.html
16. ^ Thacker, Paul, "How Scientific Literature Has Become Part of Big Pharma's Marketing Machine and How Being Nice Hurts Canada: 5 Questions with Ghostwriting Expert Trudo Lemmens", Project On Government Oversight, Jun 22, 2011
17. ^ 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(2):317–321
18. ^ Article requirements — BMJ resources
19. ^ Schultz HY, Blalock E. Transparency Is the Key to the Relationship between Biomedical Journals and Medical Writers. Journal of Investigative Dermatology (2007) 127, 735–737
20. ^ Wilson, Duff; Singer, Natasha (September 11, 2009). "Ghostwriting Is Called Rife in Medical Journals". The New York Times. http://www.nytimes.com/2009/09/11/business/11ghost.html. Retrieved May 12, 2010. 
21. ^ Singer, Natasha (August 5, 2009). "Ghostwriters Paid by Wyeth Aided Its Drugs - NYTimes.com". The New York Times. http://www.nytimes.com/2009/08/05/health/research/05ghost.html. Retrieved May 12, 2010. 
22. ^ Jacobs A, Hamilton A. Decreased evidence of ghostwriting in a 2008 vs 2005 survey of medical writers. The Write Stuff 2009;18(2):118-123. Available online at http://www.emwa.org/JournalArticles/JA_V18_I2_Jacobs1.pdf
23. ^ Grassley, Charles, ed (June 24). "Ghostwriting in Medical Literature". Minority Staff Report,111th Congress,United States Senate Committee on Finance. Washington, DC. http://grassley.senate.gov/about/upload/Senator-Grassley-Report.pdf. Retrieved 2010-07-11