Hormone Therapy Trial Opens in Reno for Six-Week Run

 

On Wednesday, September 12, a drug trial opened in Reno, Nevada to determine whether Prempro manufacturer Wyeth pharmaceuticals was malicious, negligent, or at least insufficiently cautious in its labeling and marketing of hormone-replacement therapy (HRT) drugs Prempro and Premarin. The suit was filed on behalf of three women, aged 64, 67, and 75, who were all long-time Prempro and Premarin users, who were all stricken with breast cancer, for which they claim the drugs are responsible.

In response, Wyeth attorneys claim that the company conducted studies to determine the risks associated with the drugs and worked with federal regulators to write adequate warning labels based on the best science available.

HRT is used to provide comfort for women suffering the adverse effects of menopause. Wyeth Pharmaceuticals has long touted their drugs’ ability not only to provide relief from symptoms including hot flashes, night sweats, and vaginal dryness. In addition, they claimed that HRT protected women against osteoporosis, which they essentially invented in the public’s consciousness as a disease for which their treatment would be a cure. In 1985, the company’s own research showed that 77% of women had never heard of the disease, so they created an aggressive marketing campaign both for the disease and for their drug, similar to one recently conducted for the human papillomavirus (HPV) and accompanying vaccine. Wyeth supported the creation of a National Osteoporosis Week and then a National Osteoporosis Foundation. The firm also claimed that their drug reduced the risk of cardiovascular disease in women.

However, a study conducted by the Women’s Health Initiative (WHI), was prematurely terminated in 2002 when it was concluded that the drug trial was too risky to its participants to be continued. When the results were tabulated, it seemed that the study participants experienced a 41 % increase in strokes, a 26% increase in breast cancer, and a 100% increase in blood clots compared to the control group, similar to what was seen in studies of the Ortho Evra birth control patch. The participants also experienced a 29% increase in heart attacks and a 22% increase in cardiovascular disease, conditions Wyeth had claimed were reduced by their drugs.

Even more damning is the precipitous drop in breast cancer rates since doctors dramatically reduced HRT prescriptions following the reporting of the study’s results.

In the wake of this study, legal arguments are focused on whether or not Wyeth knew or should have known from its earlier studies that these conditions were influenced by its drug. We can only wait and see what the jury decides.

If you believe you or a loved one has suffered adverse side effects as a result of taking medication, you should consult an attorney regarding the viability of any possible claim against the manufacturer or your physician.