September 2010


Wyeth's Ghostwriters Falsely Promoted Hormone Replacement Therapy

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Medical ghostwriters (sometimes disingenuously known as "editorial assistants") are scientists who are paid to "write" scientific articles, prewritten by a private company, for publication in technical journals. The company's goal is often to market a particular product, giving the false illusion that the product was the subject of independent research.

This is a win for the academic scientist who gets another publication to his or her name, and a win for the company set to profit from its misbegotten promotion. It's clearly a losing situation for everyone else, especially people who may receive medical care based on questionable science.

Adriane Fugh-Berman (Georgetown University, United States) reports on roughly 1500 documents demonstrating how (some) pharmaceutical companies use ghostwriters to promote their drugs. In particular, the former pharmaceutical company Wyeth and its ghostwriters at DesignWrite promoted the use of drugs for purposes beyond their scientifically established intent, minimized the drugs' dangers, and in my mind is criminally responsible for the adverse medical consequences of their marketing campaign.

This research is complimentary to that which has demonstrated many years of unethical and illegal prescription drug advertising in Canada.

Publications and academic marketing.

Many doctors apparently feel that hormone replacement therapy is beneficial for women who show no ill symptoms, despite definitive scientific evidence which counters this assumption. To explain the origin of this myth, we must dive into the bowels of an extremely unethical promotional campaign by Wyeth and DesignWrite.

Wyeth and DesignWrite collaborated to promote Premarin (an estrogen replacement) and other related drugs. This was an unethical collaboration, with possibly shady practices such as DesignWrite's advising on how to market Premarin for maximum influence, to entirely unethical practices such as advising Wyeth on "authors" to ghostwrite publications.

From 1997 to 2003, DesignWrite helped Wyeth publish over 50 peer-reviewed publications. DesignWrite also led over 50 other marketing adventures, e.g. symposia and posters.

Wyeth paid DesignWrite $20,000 for each of 20 "review" articles on Premarin and hormone replacement therapy. Wyeth even specifically instructed an internal committee to increase output of favorable articles.

It's illegal under United States law for a pharmaceutical company to promote a drug for purposes beyond those approved by the Food and Drug Administration. Wyeth cleverly got around this restriction by promoting off-label uses in academic journals and other publications which are not subject to promotional laws.

Reviews, commentaries, and conference presentations often influence clinical recommendations. Fugh-Berman's article lists many ghostwritten commentaries and reviews courtesy of Wyeth and DesignWrite, including but not limited to the following:

Academic scientists were specifically instructed by Wyeth and DesignWrite to slap their name on pre-written publications. The role of the supposed authors was so trivial that DesignWrite, not the alleged "authors" of the manuscripts, replied to the comments which follow peer review.

Wyeth and DesignWrite clearly worked together to unethically promote hormone replacement therapy in academic publications, under the false guise of independent research and independent expert opinion. Their shenanigans went well beyond those in academia, discussed next.

False messaging.

DesignWrite knew in 1997 that hormone replacement therapy is a treatment with no established medical use in non-symptomatic women. They nevertheless aggressively marketed hormone replacement therapy for various clinical applications, including cardiovascular, skin, and psychological conditions.

DesignWrite repeatedly questioned the risk of breast cancer associated with hormone replacement therapy. DesignWrite and Wyeth orginally challenged the efficacy of competitors' drugs and generic variants of Premarin, until Wyeth started developing its own new drug, at which point DesignWrite began writing articles in favor of new drug development.

Wyeth and DesignWrite even went so far as to organize scientific symposia (e.g. "Expert Forum on Breast Cancer Health," in Philadelphia in April 2001) and writing supplements to scientific publications (e.g. "Postmenopausal Hormone Therapy and Breast Health: A Review for Clinicians"), with the explicit goal of marketing hormone replacement therapy. Symposia and supplements project an air of scientific credibility, which in the case of Wyeth added unwarranted scientific weight to shady and possibly illegal drug marketing adventures.


Medical ghostwriting is not limited to Wyeth and DesignWrite. We don't know the extent of this practice, but some medical journals have taken notice and explicitly forbid it.

Furthermore, scientists should learn to view such relationships with drug companies as unethical. These actions, when taken across the board by the medical community, will go a long way towards preventing patients from being the victim of predatory marketing behavior by pharmaceutical companies and their hired goons.

comment added September 15: I feel I should explicitly state that not all pharmaceutical companies are "bad companies;" they perform essential, life-saving functions. Nevertheless, highly criminal behavior among them is unacceptable, as is that of any other company or individual.

NOTE: No funding was reported for this research. Fugh-Berman was a paid scientific witness in legal action against Wyeth, and currently directs a university-based institute committed to countering unethical drug promotion practices.

Fugh-Berman was not paid to research or write the contents of her scientific manuscript. A further competing interest statement is that PLoS Medicine, the techical journal in which Fugh-Berman published her research, was a plantiff in a lawsuit against Wyeth for falsely marketing its hormone replacement drugs. for more information:
Fugh-Berman, A. J. (2010). The Haunting of Medical Journals: How Ghostwriting Sold "HRT" PLoS Medicine, 7 (9) DOI: 10.1371/journal.pmed.1000335