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Hormone Drug Basis For Lawsuit

May 21, 2004 | The Cincinnati Enquirer

Ten Ohio women filed a lawsuit Thursday against several major pharmaceutical companies three with offices in Cincinnati saying the hormone therapy drugs manufactured by the companies caused their breast cancer and, in one case, a debilitating stroke.

The lawsuit was filed in Hamilton County Common Pleas Court. Other cases with similar allegations have been filed recently in U.S. District Court.

Named as defendants are: Wyeth and its division Wyeth Pharmaceuticals Inc. of Columbus; Pharmacia and Upjohn Corp. of Cleveland and Pharmacia Inc. of Cleveland; Pfizer Inc. of Cincinnati; Greenstone Ltd. of Cincinnati; Solvay Pharmaceuticals Inc. of Cleveland; Barr Pharmaceuticals of Columbus; and Duramed Pharmaceuticals Inc. of Cincinnati and Columbus.

Duramed, now owned by Barr Pharmaceuticals, has a plant in Pleasant Ridge.

The women accuse the pharmaceutical companies of negligence, producing a defective product, not providing adequate warnings and misrepresenting themselves.

The case centers on the drug Prempro, a hormone therapy medication marketed to menopausal women.

Wyeth could not be reached for comment Thursday night. The company Web site cautions that estrogen increases chances of a heart attack, stroke, breast cancer and blood clot.

In 1942, the FDA approved Premarin, an estrogen drug made by Ayerst, now Wyeth and Wyeth Pharmaceuticals.

The company has promoted the hormone therapy by sponsoring medical journal articles, using sales representatives and hiring experts to speak to doctors, and through press releases and advertisements, according to the lawsuit.

"Through its marketing and advertising efforts, Wyeth convinced doctors and patients that menopause was not the natural process of aging, but instead turned this process into a disease in need of drug treatment," the lawsuit said.

With regard to breast cancer risks, Wyeth represented in a video seminar that the benefits of taking estrogen far outweighed the risks for women unless they faced a particularly high risk of breast cancer.

From 1990 to 1995 Premarin became the most frequency dispensed prescription drug in the United States as a result of the marketing, the lawsuit says.

In 1994, Wyeth got approval for Prempro, a once-a-day pill that combines estrogen and progestin.

Some studies now show hormone therapy poses substantial health risks.

"It is clear these warnings and labels provided by manufacturing defendants were inadequate, misleading and inaccurate," the lawsuit said. "Manufacturing defendants minimized the risks of these drugs to the prescribing physicians and ultimate users while simultaneously exaggerating the purported benefits.

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