Unsealed Court Documents Reveal Details Of Lawsuits Over Hormone Therapy

The New York Times on Sunday examined recently unsealed court documents from lawsuits arguing that drugmaker Wyeth oversold the benefits of its menopausal hormone drugs while failing to warn of their risks. Lawyers released some of the documents earlier this year, and the New York Times and the Public Library of Science successfully filed motions to unseal thousands more. According to the Times, the documents paint Wyeth as company that "over several decades, spent tens of millions of dollars on influential physicians, professional medical societies, scientific publications, courses and celebrity ads, inundating doctors and patients with a sea of positive preventive health messages that plaintiffs' lawyers say deflected users' attention from cancer concerns." Over the last seven years, 13,000 people have sued Wyeth -- absorbed earlier this year by Pfizer -- alleging that Prempro and other hormone drugs caused breast cancer and other health problems.

In the mid-1990s, the labels for Wyeth's Prempro and Premarin hormone drugs said that the medications were FDA approved for treating moderate to severe menopause symptoms, such hot flashes, and to prevent osteoporosis. However, after studies found that the drugs had a protective effect on the heart, Wyeth began marketing hormone therapy as a preventive treatment for warding off heart disease and other conditions, court documents state. Commercials for the drugs emphasized a link between menopause and heart disease, memory loss and sight loss and suggested that the drugs could reduce those risks. Wyeth paid millions of dollars to doctors and medical groups to develop abstracts for medical conferences and articles for journals touting the drugs. Sales of the drugs peaked in 2001 at about $2 billion, making them a blockbuster for the drugmaker, but they plummeted after a 2002 Women's Health Initiative study linked the drugs to breast cancer, heart attack, stroke and blood clots in the lungs.

Today, many doctors limit hormone therapy to women with specific menopause symptoms and avoid prescribing the drugs beyond menopause. "Right now, the big difference is we do not recommend hormone therapy for good health or health promotion or anti-aging," Lynne Shuster, director of the women's health clinic at the Mayo Clinic, said (Singer/Wilson, New York Times, 12/13).


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