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Susan Sherry says she and her colleagues at Community Catalyst were "blown away" to learn that Estratest, a combination of estrogen and testosterone that has long been prescribed to treat menopause symptoms, has never been approved by the Food and Drug Administration.
"It literally left me speechless," says Sherry, deputy director of the Boston-based health advocacy group.
In the first half of 2006, women in the USA spent nearly $90 million on unapproved estrogen-plus-testosterone pills, says IMS Health, a pharmaceutical information company. Estratest, made by Solvay Pharmaceuticals, represented 75% of the market.
In an e-mail to USA TODAY, Solvay spokesman Neil Hirsch said the company "stands behind the safety and efficacy of Estratest brand products. After more than 40 years of patient use and 39-plus million prescriptions written for the product, Estratest continues to serve as an important therapeutic alternative."
Yet, in April 2003, the FDA stated in the Federal Register that it no longer believed there was "substantial evidence" of the hormone combination's effectiveness. The FDA invited manufacturers to ask for a hearing if they disagreed. Solvay and Breckenridge, maker of Syntest, quickly did so. The hearing has yet to be held, so the makers can keep selling their products.
In 2003, some consumer groups, part of Community Catalyst's Prescription Access Litigation Project, sued Solvay in California Superior Court in Los Angeles. The suit partly seeks to stop "false and misleading advertising related to the marketing and sale" of Estratest. "Physicians all over the country think this is an approved drug," says Steve Berman, a Seattle attorney for the plaintiffs.
The Washington, D.C.-based National Women's Health Network petitioned the FDA last month to ban estrogen-plus-testosterone pills. The petition notes that one Estratest or Syntest pill contains as much as eight times the testosterone in one Intrinsa testosterone patch, developed to treat low libido in women. Concerned about long-term safety, an FDA advisory panel unanimously recommended not approving Intrinsa in 2004.
Reid-Provident, now Solvay, did seek approval for Estratest and lower-dose Estratest H.S. in 1981, but the FDA has never acted on those applications.
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