Massive economic, health impact from WHI trial

The National Institutes of Health (NIH) issued a report last week on the massive economic and health impact of the landmark 1992-2002 clinical trial that considered the health consequences of combined hormone therapy (CHT). The trial was conducted by the Women’s Health Initiative (WHI).

The disease-simulation modeling report, published in the current issue of Annals of Internal Medicine, found that the WHI trial has provoked a sea change in women’s medical treatment, saved thousands of lives and, for an upfront cost of $260 million (in 2012 dollars), produced a net economic return of $37.1 billion — a return of $140 for every dollar invested in the trial.

The CHT trial, one of the most expensive studies ever funded by the NIH, was conducted from 1992-2002 in 40 clinical center locations throughout the United States, including the Buffalo WHI Center headed by Jean Wactawski-Wende, professor in the Department of Epidemiology and Environmental Health, UB School of Public Health and Health Professions.

“The NIH report highlights the importance of funding medical research and conducting large-scale clinical trials,”
Wactawski-Wende says. “We now know that as a result of the decline of combined hormone therapy, a projected 126,000 women were spared a breast cancer diagnosis and many thousands more spared diagnoses of cardiovascular disease and deep vein thrombosis.

“We are proud to be a part of this research,” she says, “and it’s important that we acknowledge the women who joined this study. They have had a positive impact on the lives of many other women.”

To date, more than 160,000 women have participated in the WHI studies, nearly 4,000 from Western New York. Of these, 27,000 women participated in the CHT trials — about 700 from Western New York.

Wactawski-Wende explains the CHT trial was conducted between 1993 and 2002, and its outcomes reported in the Journal of the American Medical Association (JAMA) in 2002. The trial was stopped in July 2002 when it was found that, although CHT did combat bone loss, hot flashes and other symptoms of menopause, it also significantly raised a woman’s chance of developing cardiovascular disease, stroke, blood clots and breast cancer.

When the negative consequences of CHT were reported, it provoked a fast decline worldwide in the use of menopausal hormone therapy. Shortly after this, a national reduction in breast cancer was seen. Similar findings were reported worldwide.

Joshua A. Roth of Seattle’s Fred Hutchinson Cancer Institute, first author of the NIH report, says it cites certain down sides to the drop in CHT use.

These include 263,000 more women who reported having an osteoporotic fracture and 15,000 more diagnosed with colorectal cancer. However, Roth says he and his colleagues concluded that the quality of life, mortality and cost impacts of these increases were more than offset by decreases in breast cancer, cardiovascular disease and blood clots. The study pointed out that other therapies can help prevent fracture, with fewer side effects than CHT.