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Sen. Grassley Questions Wyeth Ghostwriting Practices

Posted by Chrissie Cole
Sunday, December 14, 2008 10:07 PM EST
Category: Major Medical
Tags: Wyeth, FDA and Prescription Drugs, Hormone Replacement Therapy, Prempro, Breast Cancer


IMAGE SOURCE:© iStockphoto/ file cabinet/ blackred

Wyeth, pharmaceutical company, is accused of hiring ghostwriters to produce medical journal articles favoring its hormone replacement therapy (HRT) Prempro, according to Congressional letters seeking more information about the company’s involvement in medical ghostwriting.

The drugmaker hired DesignWrite Inc., a medical coding company, to draft articles related to the Wyeth products and breast cancer risks, according to letters released from Sen. Charles Grassley (R-IA).

Wyeth makes Prempro and Premarin – both hormone replacement drugs.

The inquires came as part of the Senate Finance Committee's ongoing examination of "medical ghostwriting," part of a broader probe into the influence of drug companies on the health-care industry.

In the letters, Grassley seeks information about the arrangement between Wyeth and the company.

Mr. Grassley’s staff released several of internal corporate documents gathered from lawsuits that show the central, previously undisclosed role of Wyeth and DesignWrite in creating articles promoting hormone therapy for menopausal women as far back as 1997.

In May 2003, an “Editors’ Choice” feature was published in The American Journal of Obstetrics and Gynecology, a year after the Women’s Health Initiative, a large federal study, linked Wyeth’s drug Prempro, a combination of estrogen and progestin to breast cancer.

The documents also show Wyeth executives came up with ideas for medical journal articles, titled them, drafted outlines, paid writers to draft manuscripts, recruited academic authors and picked publications to run the articles – all while failing to disclose the companies’ role to journal readers and editors.

“Any attempt at manipulating scientific literature, that can in turn mislead doctors to prescribe drugs that may not work and/or cause harm to their patients is troubling,” Grassley wrote to Wyeth.

Grassley’s inquiry reflects old arguments that have been used in court cases against Wyeth and were rejected, said Michael Lampe, a Wyeth spokesman.

“The authors of the articles in question, none of whom received payment, exercised substantive editorial control over the article content and had the final say, in all respects, over the content,” Mr. Lampe said.

Merck & Co. came under fire for hiring ghostwriters to author studies. An editorial in the Journal of the American Medical Association (JAMA), in April, revealed the company manipulated dozens of publications to promote one of its products, the painkiller Vioxx (rofecoxib).

Based on internal company documents revealed in Vioxx litigation, JAMA authors uncovered how the company, without disclosing it, compensated ghostwriters who aren’t even doctors, to create articles for professional journals that have the potential to influence doctors and popularize drugs prescribed to the public.

Wyeth is facing more than 8,500 legal claims by women across the U.S. who claims the hormone replacement drugs caused breast cancer and other health injuries. #

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