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Well-Meaning Concern That Went Too Far : Government reverses drug-research policy regarding women

March 28, 1993

The Food and Drug Administration's longstanding policy of barring women of childbearing age from being subjects of medical drug research began with the best of intentions. But an announcement from the agency last week clearly acknowledged that, however well-intended, the policy was misguided: The FDA now will require that research submitted for approval of new drugs include data about effects on women.

The now-canceled policy evolved after medical tragedies stemming from the use of drugs during pregnancy, tragedies that reverberate decades later.

During the late 1950s hundreds of babies were born with severely deformed limbs to women in England and Europe who had taken the sedative thalidomide, which never gained approval in the United States. From the late 1940s through the early 1970s thousands of "DES daughters" were born in the United States to women who took that synthetic hormone, which was then believed to prevent miscarriage. The drug was later found to cause cancer and other serious reproductive problems in those children.

LIVING REMINDERS: These tragedies, among others, ultimately prompted physicians to warn women against the use of any drugs or alcohol during pregnancy for fear of damaging the fetus. And the children born with these defects, now adults, have also served as haunting reminders of the dangers of drug research on young women who may become pregnant during testing. Thus what began as an informal agency custom of excluding young women from testing became formal policy in 1977.

As a direct though unintended consequence of that policy, the FDA now says, up to half of all drug safety experiments conducted in recent decades excluded women altogether. Even when women were included, generally in the later stages of drug testing, the data was often not analyzed to see if the drugs affected women differently, thus risking health damage in women if side effects were not noticed. Well-intentioned efforts to avoid more reproductive calamities have, inadvertently, extracted a high price.

A growing body of research in recent years clearly demonstrates that many drugs do indeed act very differently in women's bodies because of physiological differences from men such as hormones and the proportion of body fat. Without accounting for those differences, physicians can prescribe the wrong drug dosages for women, making those drugs useless or worse. For example, oral contraceptives, now used by millions of American women of childbearing age, sometimes block the effects of other drugs, or those other drugs can compromise the effectiveness of the contraceptives.

A WELCOME SENSITIVITY: So the FDA has wisely done an about-face. Drug companies will now have to conduct analyses by sex in virtually all applications for new drugs except those that will probably be given only to men, such as drugs designed for prostate cancer.

To ensure that there are adequate precautions against birth defects, the agency will require companies to include a special statement in the informed-consent documents signed by test participants; in that statement, a participant must affirm that she is taking contraceptive pills or for some other reason is unlikely to become pregnant during the test.

In recent years, the FDA, along with the National Institutes of Health, has become more sensitive to the special health needs of women. Research on heart disease in women and on the causes of and treatment for breast cancer, too long ignored, now commands more attention and funds. With a new effort to carefully weigh the risks for women against the significant benefits, the FDA is taking an important step forward to promote American women's health.

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