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Unsealed Docs In Prempro, Premarin Lawsuits Highlight Wyeth Ghostwriting Efforts

Aug 5, 2009 | Parker Waichman LLP

accordant switch who did not contribute much to the actual piece.

According to the Associated Press,  a federal judge overseeing hormone replacement therapy lawsuits on Friday ordered that thousands of pages of documents regarding Wyeth's ghostwriting practices be unsealed.  The New York Times was among the parties that had petitioned to have the documents unsealed.   Over 8,000 lawsuits have been combined before U.S. District Judge Bill Wilson that focus on Wyeth's hormone replacement drugs Premarin and Prempro,  and their link to  breast cancer, the Associated Press said.

According to the Associate Press, "ghostwriting is when a drug company conjures up the concept for an article that will counteract criticism of a drug or embellish its benefits, hires a professional writing company to draft a manuscript conveying the company’s message, retains a physician to sign off as the author and finds a publisher to unwittingly publish the work".  The published articles are then presented to "physicians as independent proof that the companies’ drugs are safe and effective". As we have reported in the past, critics claim it is a common practice.

According to the New York Times, Wyeth managed to publish 26 such ghostwritten articles supporting hormone replacement therapy. In many cases, the articles purported to analyze existing research and offer treatment recommendations, the Times said.  The true authors of the articles were not disclosed.  They emphasized the benefits of hormone therapy and de-emphasized the risks.

The 26 articles were published in 18 medical journals including The American Journal of Obstetrics and Gynecology and The International Journal of Cardiology between 1998 and 2005, the Times said.

We have long been reporting on the frequent use of ghostwriting by drug makers. For instance, earlier this summer we reported that Zyprexa maker Eli Lilly apparently asked doctors to put their names on articles written by company officials in an effort to promote the drug. The company’s alleged strategy to use ghostwritten articles to increase Zyprexa sales was revealed when more than 10,000 pages of internal documents were unsealed in May in lawsuits alleging Eli Lilly exaggerated Zyprexa’s effectiveness.

Last April, the Journal of the American Medical Association published analysis of court documents uncovered in the course of Vioxx injury lawsuits that found that Merck & Co. employees worked alone or with publishing companies to write Vioxx study manuscripts and later recruited academic medical experts to put their names as first authors on the studies.

According to the Times report, Wyeth adopted a policy in 2006 requiring that listed authors must become involved early in the publication process.  Under the policy, financial assistance by Wyeth or contributions by medical writers must be acknowledged in the published text.

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