Sen. Grassley Sends Letters To Wyeth, Medical Communications Firm Seeking Information About Journal Article

Main Category: Primary Care / General Practice
Also Included In: Pharma Industry / Biotech Industry
Article Date: 16 Dec 2008 - 5:00 PST

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

In the letters, Grassley also requested information about the process of selecting the physicians whose names have appeared with 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 a year after the federal Women's Health Initiative study linked the treatment to breast cancer (New York Times, 12/13). NIH researchers ended the WHI study of combination HRT in July 2002, three years earlier than scheduled, because they determined that the treatment might increase the risk for heart disease, invasive breast cancer and other health problems (Kaiser Daily Health Policy Report, 7/24/07).

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).

Investigation
According to the Journal, Grassley also is exploring possible "ghostwriting practices" by other major pharmaceutical companies and is examining medical journals' "role in maintaining scientific integrity for the papers they publish."

In a statement, Grassley said, "The ghostwriting issue is important because it concerns the integrity of the scientific views expressed in medical journals," adding, "Shedding light on the relationships between drug companies and authors helps establish accountability and safeguard the credibility of influential medical journals" (Wall Street Journal, 12/13). According to guidelines from the World Association of Medical Editors, ghost authorship, or a substantial contribution not disclosed in the article, is "dishonest and unacceptable," the Times reports (New York Times, 12/13).

Reaction
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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