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More Women in Studies, But Data Still Lacking

April 19, 2001

WASHINGTON (Reuters Health) - More women may be participating in clinical trials, but there is still little gender-specific information coming out of those studies, consumer advocates complained to Food and Drug Administration (FDA) officials on Wednesday.

At a meeting aimed at encouraging partnership between women's health groups and the federal government, advocates said they are disappointed that the FDA has not done more to require pharmaceutical and medical device manufacturers to analyze whether women respond differently to their products.

FDA officials said determining gender and racial differences requires large studies that most manufacturers have not been willing to conduct. The agency and the industry are working on more efficient and less costly ways to figure out how drugs or devices affect men and women.

But, noted the officials, the medical products industry has become much more accepting of women in studies. New survey data indicates that women are now participating in clinical studies at the same level as men, said Janet Woodcock, head of FDA's Center for Drug Evaluation and Research.

``In the past, women have been underrepresented,"" said Woodcock, adding that they now seem to have reached parity with men.

Much of the increase is due to FDA suggestions and rules encouraging pharmaceutical and medical device makers to include more women in studies, said Woodcock.

In 1993, the agency first suggested that women of child-bearing age could be included in trials. Five years later, the agency began requiring drug and device companies to report the age, race and gender of trial participants.

Then, last year, the agency ruled that women could not be excluded from trials of products for life-threatening disease solely because they were of child-bearing age.

``It is good there are more women in clinical trials, but that comes at a cost,"" said acting FDA Commissioner Bernard Schwetz, who noted that women are still exposed to risks in trials, particularly if they become pregnant while taking an experimental drug.

But he said that FDA is working to minimize those risks.

Theresa McGovern, director of the Women's Health Advocacy Project at Columbia University, said the FDA has done much to encourage drug and device companies to include more women in studies, but said her organization still had many concerns.

Most trials require women of child-bearing age to use a detectable form of birth control, which deters some from participating, said McGovern.

She said drug and device makers should be required to analyze how their products affect people by gender, age, and race and called on the agency to find a way to do so.

Woodcock noted that even as pharmaceutical and medical device makers discover more about how their products work in women, gender may turn out to be a less important factor than genetic variability from individual to individual.

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