According to the New York Times, Wyeth, a giant pharmaceutical company, paid ghostwriters to produce medical journal articles favorable to its female hormone replacement therapy Prempro. Wyeth admitted this in response to a Congressional inquiry investigating the company’s involvement in medical ghostwriting. At least one of these articles was published after a federal study found the drug raised the risk of breast cancer.
“Any attempt to manipulate the scientific literature, that can in turn mislead doctors to prescribe drugs that may not work and/or cause harm to their patients, is very troubling,” Mr. Grassley, an Iowa Republican, wrote Friday to Wyeth’s chairman and chief executive, Bernard J. Poussot.
Mr. Grassley’s staff on the Senate Finance Committee released dozens of pages of internal corporate documents gathered from lawsuits showing the central, previously undisclosed connection between Wyeth and DesignWrite in creating articles promoting hormone therapy for menopausal women as far back as 1997.
At the peak of hormone replacement therapy, in 2001, more than 126 million prescriptions for such drugs were written for women in the United States. Sales that year, primarily by Wyeth, were $3 billion. But after the federal findings of cancer risks, sales of the hormone drugs plummeted. The drugs, which contain cancer warnings on the label, are still approved to treat severe symptoms of menopause, but their use is advised at only the lowest possible doses.
The medical journal articles all involved reviews of clinical studies and other research. While such reviews are common in medical publishing, what Mr. Grassley contends happened with the Wyeth-commissioned articles is that those expert authors whose names appear on the articles became involved only after outlines or drafts of the articles were already written.
Two months before the negative findings of the federal study were released, a May 2002 memo to DesignWrite employees said that Michael S. Dey, who was president of Wyeth’s Women Healthcare Business unit, asked a committee to increase the number of positive journal articles related to another of its hormone replacement drugs, Premarin. “Mike would like us to publish at least 1 study per month,” the memo said.
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