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The rise and fall of hormone therapy: what began decades ago with promises of eternal youth for women ended last year with troubling research findings that hormone therapy drugs cause cancer, heart attacks, and other serious side effects. New litigation seeks compensation for injured women.

Article Excerpt
On July 9, 2002, the National Institutes of Health sent shock waves through the medical and scientific communities when it released a study on the benefits and risks of so-called combination hormone replacement therapy (HRT). After decades of promotional claims that long-term HRT use could provide cardiovascular benefits to menopausal women and make them look and feel "feminine forever," the drugs' mystique was shattered: The study revealed that long-term HRT use increased the risk of cardiovascular disease, invasive breast cancer, stroke, heart attack, pulmonary embolism, and blood clots. (1) Almost simultaneously, a separate study by the National Cancer Institute reported that women who take estrogen alone--rather than in combination with other hormones--over a long period are at significantly increased risk of developing ovarian cancer. (2)

Immediately, sales of hormone therapy drugs plummeted, (3) as doctors and patients alike learned for the first time that long-held notions of the drugs' safety and efficacy were misguided. How could millions of women and their doctors have believed for decades that long-term hormone therapy was a prudent course of treatment, without being advised of the risks by the companies that made the drugs? The answer lies in a remarkable marketing campaign orchestrated by the manufacturers that convinced doctors and patients that menopause is a medical disorder that must be treated with prescription medication. As a result, countless women have suffered adverse health effects, and today a new mass tort litigation is emerging.

HRT includes the use of conjugated (chemically modified) estrogens and progesterone (or, more precisely, its synthetic form, progestin), and sometimes androgen, a male hormone. The most prescribed HRT drug available is Wyeth Laboratories' Prempro. Estrogen used alone is known as ERT, or estrogen replacement therapy. The most prescribed drug in this category is Wyeth's Premarin. In all, about 10 companies manufacture the more than two dozen hormone therapy products currently available.

Combination HRT is generally prescribed for women who have made the natural transition to menopause through aging; women who have experienced menopause through surgical removal of their uterus generally use ERT. Despite the terminology commonly used to describe them, hormone "replacement" drugs do not actually replace the natural hormones produced in a woman's body that are lost during menopause. These synthetic alternatives are merely substitutes, not replacements, for natural hormones.

During menopause, a woman's estrogen level drops sharply, resulting in a lower level of calcium in the skeleton. As a result, the risk of osteoporosis and spinal, hip, and other fractures goes up. The rates of heart disease, stroke, and cancer also increase in menopausal women. (4)

Menopause has been described in scientific literature since the late 1800s. By the start of the 20th century, researchers had begun seeking an aid that would help women maintain their youth, health, sexuality, and vitality. Increasing awareness of the physical effects of menopause made a drug to "cure" it a blockbuster waiting to happen. In 1942, Ayerst Laboratories (which merged with Wyeth in the 1980s), received FDA approval to patent and market that blockbuster.

The marketing blitz begins

Ayerst's product was Premarin, a mix of estrogens extracted from the urine of pregnant mares. Almost immediately, researchers began investigating the effects of estrogen therapy on the women who used it. In 1952, an early study showed that hormone treatment may help...

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