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Prempro Risks Downplayed by Ghostwriters

Oct 21, 2010 | Parker Waichman LLP

A study published in September has concluded that Wyeth Pharmaceuticals used ghostwritten articles to hide the risks of hormone replacement therapy. Wyeth, now a unit of Pfizer, makes Prempro, which like other hormone replacement therapy drugs, has been associated with a higher risk of breast cancer.

As we’ve reported in the past, ghostwriting involves the act of a drug company producing a journal article aimed at either counteracting criticism of a drug or embellishing its benefits. Usually, a drug maker hires a professional writing company to draft the article, and recruits a physician to sign off as the author. Once the article has been published, drug sales reps often present copies of the piece to physicians as evidence that the drug covered in the article is safe and effective. Critics of the pharmaceutical industry claim ghostwriting is a common practice.

A recent survey published just last month in the Journal of the American Medical Association found that 7.8 percent of 900 research articles, reviews, or editorials that appeared in six general medical journals in 2008 were written by un-credited ghostwriters. So-called “Honorary Authors” were also listed in about 20.6 percent of medical journal articles the researchers reviewed. An Honorary Author is someone credited with an article, but who in reality contributed very little.

According to an analysis published last month in PLoS Medicine, Wyeth used ghostwriters to insert desired messages into articles published in medical journals. According to a CNN report, the documents became public when PLoS Medicine and the New York Times argued that ghostwriting undermines public health and that documents backing this practice should be unsealed. The documents were part of litigation brought by women who claim they developed breast cancer because of hormone therapy.

According to CNN, the lawsuits allege Wyeth paid a company called DesignWrite to produce multiple articles about the benefits of Prempro. The PLoS analysis states that these articles “implied that estrogen could preserve youth and health.” They played down the drug’s risks, and promoted Prempro for unproven uses.

While this was going on, Prempro was being prescribed to millions of women who had no symptoms. According to the PLoS article, some women may have paid a steep price for this practice: “In 1975, an eight-fold increase in endometrial cancer was linked to estrogen use and estrogen sales decreased.” The authors point out that even today, many doctors still believe the benefits of hormone therapy outweigh the risks in women without menopause symptoms.

In 2002, the true risks of hormone therapy were made apparent when the Women’s Health Initiative (WHI), a major study conducted by the National Institutes of Health (NIH), determined that Prempro and similar drugs significantly increased the risk of stroke, blood, clots, heart attacks and breast cancer. The results were so alarming that the NIH canceled the study, citing risk to the study’s participants.

Just yesterday, we reported that a follow up to the WHI found that use of drugs like Prempro was associated with double the risk of death from breast cancer.

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