September 8th, 2010
04:10 PM ET
Pharmaceutical giant Wyeth paid hundreds of thousands of dollars to ghostwriters to write misleading information about hormone therapy, promoted benefits and downplayed the negative effects of hormones, according to an analysis published in PLoS Medicine.
The analysis by Dr. Adriane J. Fugh-Berman of Georgetown University Medical Center says that Wyeth, now part of Pfizer, manipulated media messages when it used ghostwriters to insert desired messages into articles published in medical journals.
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. A federal judge agreed. The documents are part of litigation by 14,000 women who claim their use of the hormones led to their development of breast cancer.
Wyeth is accused of paying a company - DesignWrite - hundreds of thousands of dollars to produce multiple articles about the benefits of Prempro, a brand of hormone therapy that became the first FDA approved treatment for hot flashes in 1942.
The analysis of those articles found that they “implied that estrogen could preserve youth and health." Further, the study says, physicians were prescribing estrogen to millions of women who had no symptoms.
"In 1975, an eight-fold increase in endometrial cancer was linked to estrogen use and estrogen sales decreased," Fugh-Berman wrote. "Today, despite definitive scientific data to the contrary, many gynecologists still believe that the benefits of HT outweigh the risks in asymptomatic women. This non-evidence based perception may be the result of decades of carefully orchestrated corporate influence on medical literature.”
The articles were crafted to downplay the perceived risks of hormone therapy and to promote unproved uses for hormone therapy, such as preventing dementia, Parkinson’s disease, vision problems and wrinkles, according to Fugh-Berman’s analysis.
Use of HRT fell in 2002 after the Women's Health Initiative study linked the use of hormones to increased risk for breast cancer, ovarian cancer, strokes and other problems.
Fugh-Berman was a paid expert witness on behalf of plaintiffs referred to in the paper. PLoS Medicine says the doctor was not paid for any part of writing or researching the paper.
In a written statement, Pfizer said, “The author of this article, Dr. Adriane Fugh-Berman, is a paid expert witness for plaintiffs in hormone therapy litigation, and even with her critical perspective, she could not establish that there were inaccuracies in any of the peer reviewed articles, or that their authors relinquished control over their work. The PLoS article breaks no new ground and fails to acknowledge the significant changes in policy undertaken by Pfizer and other companies to help strengthen disclosure in connection with medical literature. Most importantly, this article completely – and conveniently – ignores the fact that the published manuscripts were subjected to rigorous peer-review by outside experts on behalf of the medical journals that published them, and that their integrity and scientific rigor has even been recognized by multiple courts.”
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