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Doubts Prompt Reviews of Hormone Therapy

Vaccination News Home Page

http://www.nytimes.com/2002/08/15/health/15HORM.html

The New York Times The New York Times Health August 15, 2002  


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Doubts Prompt Reviews of Hormone Therapy

By GINA KOLATA

Responding to growing doubts about the safety and value of hormone replacement therapy in women after menopause, two federal agencies are reviewing what is known about the drugs and what women and their doctors should be told about them.

The National Institutes of Health said this week that it would hold a public meeting on Oct. 23 and 24 in Bethesda, Md., to discuss questions about the therapy. The Food and Drug Administration is reviewing the labeling of hormones.

The goal of the October meeting, said Dr. Vivian Pinn, director of the institutes' Office of Women's Health, is to address confusion in the wake of a federal study last month that found increased health risks from one hormone combination taken by millions of women. Dr. Pinn said participants would also discuss whether recent findings from that study, the Women's Health Initiative, could be generalized to similar products.

Researchers, doctors and the public will be invited, she said, along with representatives from drug companies, professional groups and federal agencies.

The meeting was announced discreetly on Tuesday on the Web site of the Food and Drug Administration (www.fda.gov/cder/drug/safety/WHI_statement.htm), tucked into the end of a statement on the need to reassess the risks and benefits of hormone therapy. Yesterday, after The Washington Post published an article about the meeting, the health institutes put a notice on its Web site (www4.od.nih.gov/orwh) saying the meeting would take place but providing no details.

Increased concerns about hormone replacement therapy and the labeling of the drugs arose in July after the health institutes abruptly halted a large clinical trial of Prempro, a combination of estrogen and progestin made by Wyeth. Women taking the drug had slightly more cases of breast cancer, heart attacks and strokes than those taking a placebo, and those risks were not counterbalanced by the drug's benefits, a slight decrease in the incidence of hip fractures and colon cancer.

Another arm of the trial, involving women taking estrogen alone, is continuing because the evidence shows neither an overwhelming risk nor an overwhelming benefit. Women who have had hysterectomies generally take estrogen without progestin. For others, taking estrogen alone can lead to uterine cancer.

Prempro is approved for the prevention of osteoporosis and for the relief of symptoms of menopause, like hot flashes, but doctors had hoped it might also protect against heart disease and other diseases of aging, including Alzheimer's. Many women were advised to start taking Prempro at menopause and to continue for the rest of their lives.

But Prempro is not the only hormone replacement on the market, leaving many doctors and women with questions about whether other drugs, which are slightly different formulations, have similar risks. There are also questions about who should take Prempro and for how long.

Prempro's label was written on the basis of older studies that did not provide the sort of precise information as the new study. Those studies did indicate possible risks of heart attacks, strokes and breast cancer, however, and that is included on the drug's label.

Now, the food and drug agency is looking at the new data.

"We are going to conduct a review of the data from the Women's Health Initiative study and evaluate the product and the product labeling in light of those data," said Susan Cruzan, an agency spokeswoman.

Ms. Cruzan said the agency would also consider whether there should be changes in labeling for formulations of the hormones made by other companies. But she added that the work had just begun.

"Until we have more details, there's not a whole lot we can say," Ms. Cruzan said.

Dr. Bruce Burlington, the head of regulatory affairs at Wyeth, said the company was already planning to change Prempro's label. The company began meeting with the drug agency officials as soon as the results from the Women's Health Initiative were announced.

"We told them we needed to get warnings out and solid information out," Dr. Burlington said.

In addition to changing its label to reflect the more detailed information provided by the Women's Health Initiative study, he said, Wyeth would send letters to about half a million doctors informing them of the study's findings.

Dr. Burlington said that Wyeth expected to participate in the health institutes' meeting in October. But he added, "We don't have an agenda and we don't have an invitation as yet."




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