For years, drug companies touted the benefits of HRT. Marketing campaigns for medications like Premarin, Prempro and Provera targeted both women and their doctors, promising that the drugs could perform miracles. Manufacturers boasted these drugs could not only temper bothersome symptoms of menopause, including hot flashes, mood swings, and vaginal dryness, but they had the added benefit of protecting women against heart disease, a serious concern among older women. Use of these drugs was even encouraged for off-label uses, including the prevention of Alzheimer’s disease.
Just as HRT was becoming one of the top selling pharmaceuticals in the nation, the Women’s Health Initiative (WHI) launched an extensive study specifically designed to measure the effects of postmenopausal hormone therapy, diet modifications, and calcium and Vitamin D supplements on heart disease, fractures, and breast and colon cancers in older women. It was a randomized placebo-controlled trial initiated by the National Institutes of Health.
WHI included two different studies as part of its hormone trial: the estrogen-plus-progestin study of women with a uterus, and the estrogen-alone study of women without a uterus. In both hormone therapy studies, women were randomly assigned to either the hormone medication being studied or a placebo. But startling results stopped the study in its tracks.
In 2002, after a review of the initial data, the study on the combination estrogen-plus-progestin HRT was abruptly halted when researchers identified a definite increase in the number of breast cancer cases among women taking combination HRT compared to women on placebo. These women also showed evidence of being at greater risk for developing the condition compared to women on estrogen-only HRT. The data also showed combination HRT increased a woman’s risk for heart attack, stroke, and dementia.
The news caught the public by surprise. Prescriptions for HRT dropped not only in the United States, but also worldwide. Shortly thereafter, the incidence of breast cancer decreased.
Lawsuits against HRT maker Wyeth Pharmaceuticals began mounting, with awards reaching into the millions. Just last month, a Philadelphia, Pennsylvania, jury awarded $72.6 million to three plaintiffs in an HRT case after determining that HRT caused the women’s breast cancer. The case ultimately was settled confidentially. Ted G. Meadows of Beasley, Allen, Crow, Methvin, Portis & Miles, P.C., of Montgomery, Ala., represented the plaintiffs, along with Tobias L. Millrood and Matthew Leckman of Pogust Braslow & Millrood. Beasley Allen shareholders Navan Ward, Jr., and Russ Abney, and associate Matt Teague also worked as part of the trial team for this litigation.
“By marketing these drugs for uses that were never approved by the FDA and downplaying the risk of breast cancer, Wyeth put the lives of thousands of women at serious risk,” Meadows said. “The drug manufacturer hid the risks from thousands of women as well as doctors across the United States.”