FDAnews
www.fdanews.com/articles/70322-whi-study-of-hormone-replacement-therapy-has-limitations-expert-says

WHI Study of Hormone Replacement Therapy Has Limitations, Expert Says

March 25, 2005

Before safety concerns over Cox-2 inhibitors and antidepressant use in children made front-page headlines, the pharmaceutical industry had to deal with revelations that widely used hormone replacement therapies (HRTs) posed significant health risks -- a finding that is now being questioned by an industry analyst.

The 2002 Women's Health Initiative (WHI) study linked HRTs to increased risks of heart disease, stroke, breast cancer and blood clots. The study, conducted by the NIH, concluded that the overall risks outweighed the benefits, which included HRT's protection against osteoporotic fractures and colon cancer, according to a new report from Datamonitor, a business analysis firm.

Many experts believe the WHI study had limitations and that HRT is still the best treatment option for menopause symptom management, according to Datamonitor women's health analyst Victoria Williams. "Media-fueled misinterpretation and miscommunication of trial results has led to a culture of fear among patients over the small increases in cardiovascular and breast cancer risks associated with HRT use," she said. "However, the limitations of the study's findings have not received such wide-reaching coverage."

The initial hysteria over the WHI results prompted approximately 66 percent of women to halt their HRT regimes, she said. Between 10 percent and 25 percent of women have since returned to taking HRT, according to Datamonitor. The WHI study lowered the market value of HRT therapies in 2003 by $850 million, according to Datamonitor.

For more information on the study, "HRT: Major Milestones -- Current Perspectives on HRT and Menopause," go to http://www.datamonitor.com/~b04371c699a6450e9c6ca97e3990adec~/industries/research/?pid=DMHC2099&type=Report (http://www.datamonitor.com/~b04371c699a6450e9c6ca97e3990adec~/industries/research/?pid=DMHC2099&type=Report).