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New Interest in IUDs Triggered by Claims Old Study Was Flawed

April 16, 1991

WASHINGTON (AP) _ Intrauterine devices, once the birth control method for millions of American women, are being re-examined after a report published this week claimed that an earlier study critical of IUDs was flawed.

The new report, published in the Journal of Clinical Epidemiology, prompted a committee of the American College of Obstetrics and Gynecology to readdress the use of IUDs and could lead to further studies.

Kate Ruddon, a spokeswoman for the physicians’ group, said the new study ″appears to be something to take seriously.″

″It’s an issue that we are seriously considering and it is being reviewed by our gynecological committee,″ she said.

The new report contended that the Women’s Health Study, published in 1981, wrongly concluded that IUDs increased the risk of pelvic inflammatory disease, a condition that can cause infertility.

Dr. Amy E. Pollack, associate medical director for the Planned Parenthood Federation of America, said that if new research shows IUDs are safe, it will be good news for women because it would provide another contraceptive choice.

″Our goal is to find the best birth control method for subgroups of women,″ said Pollack. ″The IUD may be right for certain groups.″

She said IUDs now are being prescribed in the United States for women who are at low risk of pelvic inflammatory disease. These generally are women who are in a stable relationship with one sex partner.

Pollack said the new study ″revives the debate about IUDs″ but still leaves unanswered questions about an expanded use of the devices. What is needed, she said, is still another study by an impartial scientific group.

Richard A. Kronmal, co-author of the new report, said the Women’s Health Study was ″really inconclusive″ because of flaws in its selection of the women included in the study.

″Those studies were unable to show a real effect,″ Kronmal said Monday. ″It was such a heavily politicized situation with so much emotion and it was so tied up in the courts that I don’t think it was really looked at scientifically very well.″

Kronmal said he examined the raw data collected for the study and found mistakes in the selection of women to study and in the interpretation of findings.

As a result, he said, ″there are so many flaws, the study in effect tells you nothing.″

Dr. Ronald T. Burkman, head of the groups that conducted the Women’s Health Study, disputed Kronmal’s findings and said in a published rebuttal that the new report ″is replete with factual error, misrepresentation and overstatement.″

Burkman, of the Henry Ford Hospital in Detroit, said the Women’s Health Study did show that IUD users were at a higher risk of developing pelvic inflammatory disease than those who did not use IUDs.

″Although the (study) was imperfect, it contributed substantially to our understanding of the morbidity associated with use of an IUD,″ Burkman said.

The Women’s Health Study was widely used in court suits against A.H. Robins Co., the firm that manufactured the Dalkon Shield, one of the IUDs. The study also resulted in other companies removing IUDs from the market.

IUDs were a popular form of birth control in the 1970s and came in a variety of shapes and materials. The devices are inserted into the uterus and prevent conception through a manner that experts acknowledge they don’t understand.

The devices required no approval by the Food and Drug Administration when they were first marketed, but in 1974 the FDA said there were reports of infection among women using the Dalkon Shield.

Now, only about 1.5 million American women, about 3 percent of those using birth control, choose IUDs. The devices are widely used in Asia, South America and parts of Europe. Only two U.S. companies currently sell IUDs.

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