Ghost Writers In The Sky
Medical Papers by Ghostwriters Pushed Therapy
Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known.
The ghostwritten papers were typically review articles, in which an author weighs a large body of medical research and offers a bottom-line judgment about how to treat a particular ailment. The articles appeared in 18 medical journals, including The American Journal of Obstetrics and Gynecology and The International Journal of Cardiology.
The articles did not disclose Wyeth's role in initiating and paying for the work. Elsevier, the publisher of some of the journals, said it was disturbed by the allegations of ghostwriting and would investigate.
The documents on ghostwriting were uncovered by lawyers suing Wyeth and were made public after a request in court from PLoS Medicine, a medical journal from the Public Library of Science, and The New York Times.
A spokesman for Wyeth said that the articles were scientifically accurate and that pharmaceutical companies routinely hired medical writing companies to assist authors in drafting manuscripts.
The court documents provide a detailed paper trail showing how Wyeth contracted with a medical communications company to outline articles, draft them and then solicit top physicians to sign their names, even though many of the doctors contributed little or no writing. The documents suggest the practice went well beyond the case of Wyeth and hormone therapy, involving numerous drugs from other pharmaceutical companies.
"It's almost like steroids and baseball," said Dr. Joseph S. Ross, an assistant professor of geriatrics at Mount Sinai School of Medicine in New York, who has conducted research on ghostwriting. "You don't know who was using and who wasn't; you don't know which articles are tainted and which aren't."
Because physicians rely on medical literature, the concern about ghostwriting is that doctors might change their prescribing habits after reading certain articles, unaware they were commissioned by a drug company.
"The filter is missing when the reader does not know that the germ of an article came from the manufacturer," said James Szaller, a lawyer in Cleveland who has spent four years going through the ghostwriting documents on behalf of hormone therapy plaintiffs.
Sometime in 2003, a DesignWrite employee wrote a 14-page outline of the article; the author was listed as "TBD" -- to be decided. In July 2003, DesignWrite sent the outline to Dr. Gloria Bachmann, a professor of obstetrics and gynecology at the Robert Wood Johnson Medical School in New Brunswick, N.J.
Dr. Bachmann responded in an e-mail message to DesignWrite: "Outline is excellent as written." In September 2003, DesignWrite e-mailed Dr. Bachmann the first draft of the article. She also pronounced that "excellent" and added, "I only had one correction which I highlighted in red."
The article, a nearly verbatim copy of the DesignWrite draft, appeared in 2005 in The Journal of Reproductive Medicine, with Dr. Bachmann listed as the primary author. It described hormone drugs as the "gold standard" for treating hot flashes and was less enthusiastic about other therapies.
The acknowledgments thanked several medical writers for their "editorial assistance," not disclosing that those writers worked for DesignWrite, which charged Wyeth $25,000 to generate the article.
"There was a need for a review article and I said 'Yes, I will review the draft and make sure it is accurate,' " Dr. Bachmann said in an interview Tuesday. "This is my work, this is what I believe, this is reflective of my view."
The doctor needs to think about the words to this song: