The whistle-blowing article by Dr. Adriane Fugh-Berman recounts how the author was approached to serve as the front author on a manuscript already written by a "medical education company" on behalf of a pharmaceutical company. The manuscript purported to be a review of interactions between warfarin and herbal remedies. The manuscript was provided to Dr. Fugh-Berman in essentially complete form, with her name on the first page as first author. The pharmaceutical company that sponsored the writing of this manuscript had developed a new oral anti-coagulant, already approved for use in France, and with a New Drug Application pending before the US Food and Drug Administration (FDA). Presumably, the company expected that the new drug would compete with warfarin. Thus, the apparent goal of the manuscript was to disparage warfarin, the drug with which the pharmaceutical company's new product would compete.
Dr. Fugh-Berman rejected the offer from the medical education company. As luck would have it, however, the company recruited another front author, who submitted the manuscript to the Journal of General Internal Medicine, who in turn forwarded the article to Dr. Fugh-Berman as a peer-reviewer. When she recognized the manuscript for what it was, she notified the journal editors.
Prompted by this incident, Dr. Fugh-Berman began investigating the relationships among pharmaceutical and biotechnology companies and medical education companies. Based on this investigation, she made the following points:
- "Pharmaceutical companies routinely seed medical literature with revews or commentaries that advantageously frame a marketed drug, but some sponsored articles never mention the targeted drug."
- "Companies regularly fund articles and talks that never mention the targeted drug, but are meant to disadvantage the competition."
- "Articles are usually written by a medical education company (MEC) that receives funding from the pharmaceutical company."
- " Academic physicians are recruited to sign these articles. The division of labor for such acorporate-sponsored article is rarely equal: although the signed author is invited to make changes, the primary obligation of the academic coauthor is to claim authorship."
- "The primary author from the MEC remains anonymous, and any instructions given to the primary author regarding tone or emphasis are not shared with the named author."
- "True incidence of corporate ghost authorship is unknown: anecdotally, many of my colleagues who speak at national meetings have been approached with such offers."
- "The placement of articles in peer-reviewed journals is a valued marketing technique. For example, an industry conference, titled "Publication Planning 2003: Utilizing ScientificallyAccurate, Commercially Relevant Strategies for Optimal Drug Exposure" had a conference brochure that stated, "'For a manufacturer, having research published in a highly regarded peer review [sic] medical journal or presented at a leading conference is desirable.'" One workshop described changes in how pharmaceutical companies handle publishing so that "'These changes have seen publications shift from being an academic, data-driven pursuit to adopting a message-driven model that is part of a broader communication strategy and integral to pharmaceutical life-cycle management.'"
Dr. Fugh-Berman has done us the important service of describing a previously undisclosed kind of attack on the scientific basis of medical practice.
An accompanying editorial in JGIM called the events described by Dr. Fugh-Berman "an egregious case of unethical behavior by an author, a pharmaceutical manufacturer, and a medical education company." Furthermore, it charged "Publishing biased literature is not simply 'getting the message out' for the pharmaceutical client of the medical education company. It injects bias and untruth into the scientific dialogue in order to enhance corporate profits." "How much is sullying the medical literature worth in market share?"
The editorial noted that JGIM has changed its policy to require all real authors of articles to be acknowledged, and all financial arrangements among authors and other interested parties to be revealed. Apparently, the World Association of Medical Editors (WAME) will also be similarly changing their policy.
Dr. Fugh-Berman went further, suggesting developing a "publicly available, regularly updated database of conflicts of interest and ethical transgressions." "And we need a mechanism foracademicians to expose the more subtle strategies used by drug companies to affect prescribing."
In my humble opinion, the issues are even more global, and the strategies needed to combat thisegregious assault on the scientific basis of medical practice need to be broader as well.
- The scope of this practice, as Dr. Fugh-Berman noted, is unclear. We cannot assume that its use is restricted only to pharmaceutical companies. We have seen that mismanagement and unethical behavior occurs in a variety of health care organizations. It is therefore quite possible that organizations other than pharmaceutical companies use stealth techniques to inject marketing and propaganda into the scientific literature.
- Although revising journal policies is a worthwhile first step, it is doubtful that asking authors who have already agreed to front for ghost authors to tell the truth will have much effect.
- Dr. Fugh-Berman's call for a database of conflicts of interest and ethical transgressions and to facilitate whistle-blowing about them are excellent ideas. One could view Health Care Renewal as a crude first attempt to develop such a database and such a mechanism.
- We need to develop watch-dog organizations within health care to cope with what now seems an epidemic of mismanagement, conflicts of interests, dishonesty, unethical behavior, and outright crime and corruption. Main-line medical organizations have so far been reluctant to step into this fray, but maybe they can be persuaded. If not, we need to develop new organizations to fight external attacks on medical professsionalism.
Addendum: Dr. Fugh-Berman today also published a commentary in the Manchester Guardian on this case. In it, she names names, which she did not do in her JGIM article. The medical education was the British RxComms. On its web-site is the statement that RxComms writes "everything from abstracts to full manuscripts; from clinical trial reports to sales aids and slide kits." The pharmaceutical company was AstraZeneca, and the drug they hoped would compete with warfarin was ximelagatran. Dr. Fugh-Berman noted that RxComms claimed that the manuscript sent to her was actually written by the person named as first author in the version sent to JGIM. AstraZeneca claimed that it follows strict guidelines that require authors to take responsbility of the content of the articles they write. Nonetheless, "Most pharmaceutical companies, including AstraZeneca, use professional writers to assist in manuscript development, when the named authors lack the time or expertise to produce a well-written publication."