Attorneys for the research center argued that the data, which is the most recent information collected in a follow up of the Women’s Health Initiative (WHI), had not yet been analyzed, peer-reviewed or published and that allowing Wyeth to sort through the raw data was simply “preposterous.” The Cancer Research Center had been resisting Wyeth’s requests for the information through subpoenas but will now have to surrender the data.

WHI, conducted by the Department of Health and Human Services, National Institutes of Health, and the National Heart, Lung and Blood Institute, was launched in 1991 and consisted of a set of clinical trials and an observational study that involved more than 160,000 generally healthy postmenopausal women. The major 15-year research program was designed to address the most common causes of death, disability and poor quality of life in postmenopausal women – cardiovascular disease, cancer and osteoporosis.

Preliminary results of the 2002 WHI showed that women who took HRT to relieve symptoms of menopause were at an even greater risk for serious diseases and conditions such as breast cancer, ovarian cancer, cardiovascular disease, stroke and blood clots.

As a result of the study, numerous lawsuits have been filed against makers of HRT, including Wyeth. To date, there are about 8,000 plaintiffs with cases pending against Wyeth, of which 7,000 plaintiffs are part of the multidistrict litigation that falls under Wilson’s pretrial oversight.

Source: NWAnews.com

SOURCE: Hormone Replacement Therapy › Judge orders WHI follow-up data be released to Wyeth