Grassley Requests Information About HRT Drug Prempro Journal Articles

Main Category: Pharma Industry / Biotech Industry
Also Included In: Primary Care / General Practice;  Litigation / Medical Malpractice
Article Date: 17 Dec 2008 - 6:00 PST

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As part of a broader congressional investigation into the possible influence of the pharmaceutical industry on physicians and the health care industry, Senate Finance Committee ranking member Charles Grassley (R-Iowa) on Friday sent separate letters to Wyeth and the medical communication company DesignWrite about the hormone-replacement therapy drug Prempro, the New York Times reports. The letters request information about payments that Wyeth allegedly made to DesignWrite to ghostwrite medical journal articles about Prempro, according to the Times (Wilson, New York Times, 12/13).

In the letters, Grassley also requested information about the process of selecting the physicians who authored the articles about Prempro and Wyeth's other HRT drugs in peer-reviewed medical journals since 1995. Grassley also asked Wyeth to disclose complete information about any articles that were written about its pharmaceutical products by third-party authors and how the company's marketers were associated with the article-drafting process (Wang, Wall Street Journal, 12/13). The letters cite documents obtained by Grassley's staffers from lawsuits filed against Wyeth. According to the documents, Wyeth executives developed ideas for medical journal articles and wrote titles and outlines for them and then paid writers to draft the manuscripts, as well as recruited academic authors. The executives did not disclose the role of DesignWrite and Wyeth in crafting the articles, the Times reports.

One of the articles appeared as an "Editor's Choice" feature in the May 2003 issue of the American Journal of Obstetrics and Gynecology and supported the use of Prempro more than one year after the federal Women's Health Initiative study linked the treatment to breast cancer. The article -- which said that there was "no definitive evidence" that progestin, an ingredient of Prempro, caused breast cancer -- was signed by John Eden, an associate professor at the University of New South Wales in Australia and director of the Sydney Menopause Center. According to the court documents, Wyeth executives in 2000 asked Eden to write a paper using an outline and a draft that was prepared for him, and the article did not include information about links between Wyeth and DesignWrite. The documents also include a "publication plan tracking report" by Wyeth that shows 10 articles for which the company completed manuscripts before sending them to the alleged author for review, the Times reports. Any changes to the articles, which Wyeth prepared for the physicians to review, were subject to final approval from the company, according to a publication tracking report released with the documents, the Times reports (New York Times, 12/13).

Wyeth said it contacts scientists with ideas for articles and offers them the assistance of a medical writer, but gives the scientists complete editorial control (Wall Street Journal, 12/13). Michael Lampe, a spokesperson for Wyeth, said, "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." He said that Wyeth will provide a "full response" to Grassley's request (Blum, Bloomberg/Philadelphia Inquirer, 12/13). Officials for DesignWrite and its parent company JMI Health in New York did not return requests for comment, the Times reports (New York Times, 12/13).

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