FDA favors use of hormones – with caution

WASHINGTON – In an effort to offer clear advice about hormone therapy to worried menopausal women deciding whether to use it, the Food and Drug Administration on Tuesday launched a national education campaign that supports the widespread, if more cautious, use of the controversial drugs.

The campaign, which was mandated by Congress last year, emphasizes the increased risks to women that have become known in the past year. Those risks include higher rates of breast cancer, blood clots and heart disease.

But the initiative also tries to put those risks into a context that some believe was lost during the intense publicity surrounding the more negative findings of the past year. The FDA guidance concludes that because there are few proven alternatives to relieve hot flashes, vaginal dryness and other symptoms of menopause, hormone treatments “have an important role in women’s health.”

FDA Commissioner Mark McClellan kicked off the campaign by saying that women needed better information about the nature of hormone treatment, which has caused great confusion in the past year. “We want a reasoned and not an alarmist message about hormone therapy,” McClellan said.

Susan Wood, director of the FDA’s Office of Women’s Health, said: “Hormone treatment came to be seen by some as a dangerous drug, and our message is that it is not. Like all medications, it has its risks and it has its benefits.”

The recommendations were made after months of meetings among FDA and National Institutes of Health officials and representatives of 29 medical and women’s health organizations. They follow the FDA labeling for hormone treatments – that women should take the smallest effective dose for the shortest possible period of time – and emphasize that each woman must discuss her situation and risk factors with a medical professional.

Some members of the group said the discussions sometimes became heated. One participant, Diana Zuckerman, director of the National Center for Policy Research for Women and Families, said there was direct and indirect pressure on the FDA and the consulting group from the largest maker of hormone products, Wyeth Pharmaceuticals.

“There were some real battles over the wording, with some groups saying the risks were very small and women should be reassured of that,” she said. “But others said the risks had to be given equal importance, and the document is a kind of an uneasy compromise.”

A major study of combination estrogen-progestin hormone therapy by the Women’s Health Initiative came to a sudden end in the summer of 2002 when researchers noticed higher levels of heart disease, blood clots and breast cancer in the group taking hormones. Many doctors routinely had been prescribing the treatments to women in menopause based on research that seemed to find a wide range of health benefits. According to Wyeth spokeswoman Natalie DeVane, 15 million American women were taking some form of hormone treatment before the study was stopped. This past June, she said, the number was 9.2 million.

In a statement, Wyeth welcomed the FDA campaign, saying the company “believes that information about menopause and the appropriate use of hormone therapy helps women make informed decisions – in consultation with their physician or other health care professionals – about their health.”

One of the groups advocating a stronger endorsement of hormone therapies was the Society for Women’s Health Research. According to President Phyllis Greenberger, women need to know that while hormone treatment can have some dangerous consequences, the number of women likely to be affected is very small – about one-tenth of 1 percent of women, she said.

“I think we needed to give a greater explanation of the absolute risks to each woman, rather than to just list the possible harms,” she said. “If they just see the possible benefits and possible risks listed without understanding the size of the risk, they’d have to be from another planet to take the risks.”

The information will be available on a government Web site, www.4woman.gov, and will be distributed as fliers in government offices and by women’s health groups. A purse-size questionnaire for women to use when discussing hormone therapies with their doctors was created as well.