Wall Street Journal examines women's health initiative findings on HRT's effect on heart attack risk

The Wall Street Journal on Monday examined findings from the 15-year, $725 million NIH-sponsored Women's Health Initiative on hormone replacement therapy's effects on heart attack risk.

According to the Journal, in the five years since the study was released, many in the medical community have said "some aspects" of the initial findings "were either misleading" or "overgeneralized in large part because they excluded many of the study's own investigators and physicians from the first review" (Parker-Pope, Wall Street Journal, 7/9).

NIH researchers in July 2002 ended the WHI study on combination HRT three years early because they determined that the treatment might increase the risk for heart disease, invasive breast cancer and other health problems. A later WHI analysis, published in the April 4 issue of the Journal of the American Medical Association, found that HRT use among women in their 50s does not increase their risk for heart attack (Kaiser Daily Women's Health Policy Report, 4/4).

In addition, a study published last month in the New England Journal of Medicine found that women in their 50s who took estrogen on a regular basis were 60% less likely than those who took a placebo to have large amounts of plaque in their arteries, an indicator of heart attack risk. Participants who took estrogen were 30% to 40% less likely than those who took a placebo to have large amounts of plaque in their arteries. However, participants who took estrogen had a higher risk for stroke than those who took a placebo, according to the study (Kaiser Daily Women's Health Policy Report, 6/22).

According to the Journal, the WHI's 40 researchers in 2002 were told 11 days before the initial WHI study report in JAMA was released that it had been halted early. Although some of them were concerned that the results were "too broadly interpreted," it was "too late to make meaningful changes" to the JAMA article, the Journal reports. Two ongoing studies are examining the role of estrogen in the development of heart disease, the Journal reports. Both studies also will examine whether using natural progesterone, instead of synthetic progestin used in WHI, reduces or eliminates breast cancer risk.

Comments

Jacques Rossouw, a physician with the National Heart Lung and Blood Institute who had overseen the WHI since its inception, said it was an "NIH decision supported by the WHI executive committee to keep it to a small group because we realized it was a sensitive paper." He said that the handling of the study's results was "based on what we knew at the time," adding, "Our main job ... was to turn around the prevailing notion that hormones would be useful for a long-term prevention of heart disease." It was a "worthy objective, which we achieved," Rossouw said.

Robert Langer -- former principal investigator for WHI's clinical center at the University of California-San Diego, who has since spoken as a witness for HRT maker Wyeth -- said, "I think that had the initial report been written by a broader group, as almost all of our later papers have been, it would have been framed differently."

According to the Journal, key questions about long-term use of HRT are "far from resolved." Most experts agree that HRT is a reasonable option for women to treat menopausal symptoms, but the "bigger question" is whether the drugs should be used to prevent heart-related conditions, the Journal reports. NHLBI says that HRT should not be used to prevent heart disease because of its potential to increase risk for breast cancer, blood clots and strokes. According to the health care information company IMS Health, HRT sales have declined 30% since the WHI results were published in 2002 (Wall Street Journal, 7/9).