Pharmaceutical giant Wyeth is under scrutiny for its practice of paying ghostwriters to draft scientific journal articles favorable to its products and publishing them under the names of academic researchers. Some of the ghostwritten reports involve Wyeth’s hormone replacement therapy, Prempo, and deny the results of a federal study that linked the drug to an increased risk for breast cancer. The inquiries come as part of the Senate Finance Committee’s examination of “medical ghostwriting,” part of a broader probe into the influence of drug companies on the health-care industry [Wall Street Journal].
The investigation is being spearheaded by Senator Charles E. Grassley of Iowa, who last week sent a letter to Wyeth’s chairman requesting documentation of the company’s ghostwriting and publishing procedures. The letter [pdf] said Wyeth’s publications resembled “subtle advertisements rather than publications of independent research” and that “any attempt to manipulate the scientific literature, that can in turn mislead doctors to prescribe drugs that may not work and/or cause harm to their patients, is very troubling.” In response, a Wyeth spokesman accused Mr. Grassley of recycling old arguments and insisted that “The authors of the articles in question, none of whom were paid, exercised substantive editorial control over the content of the articles and had the final say, in all respects, over the content” [New York Times].
Previously released documents from Wyeth and DesignWrite, a medical writing company, reveal that Wyeth executives came up with ideas for medical journal articles, titled them, drafted outlines, paid writers to draft the manuscripts, recruited academic authors and identified publications to run the articles — all without disclosing the companies’ roles to journal editors or readers [New York Times]. The controversy centers around Wyeth’s Prempro, a combination of estrogen and progestin, and similar hormone therapies that pulled in $3 billion a year for Wyeth until a large federal study in 2002 found the drug to increase breast cancer risks. Wyeth and DesignWrite proposed and drafted an article supporting Prempro that was published in May 2003 in The American Journal of Obstetrics and Gynecology [subscription required] under the name Dr. John Edenon, an associate professor at the University of New South Wales, with no mention of ties to Wyeth or DesignWrite.
Wyeth as of Oct. 29 faced about 8,700 legal claims from women in the U.S. who contend the hormone replacement drugs caused breast cancer and other injuries, according to a company regulatory filing last month [Bloomberg]. Other pharmaceutical companies have faced accusations of unethical ghostwriting in the past. The most well-known involved Merck’s Vioxx, a painkiller that was withdrawn in 2004 after it was linked to heart problems. Currently, Wyeth’s Preempro is still on the market, although only prescribed for severe symptoms of menopause.
DISCOVER: Delay in Recalling Vioxx Points to Problems in FDA Approval Process
80beats: Drug Companies Keep Quiet on Drugs that Don’t Work
Reality Base: Drug Company Pocket-Padding: The Latest Chapter
Image: flickr / bluehorizon99