Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: MONDAY, April 15, 1991 TAG: 9104150047
SECTION: NATIONAL/INTERNATIONAL PAGE: A-6 EDITION: METRO
SOURCE: The New York Times
DATELINE: LENGTH: Medium
While the new study does not go so far as to exonerate the Dalkon Shield specifically, it concludes that intrauterine devices in general do not increase the risk of pelvic infection. That finding directly contradicts the conclusion of the original federally financed study.
The latest finding, published in the current issue of The Journal of Clinical Epidemiology, is not meant to suggest a course of action by women. But it is certain to renew debate about the value of IUDs, which are now used by an estimated 1.5 million women in this country, or 3 percent of contraceptive users, less than half the number in 1982. The devices are placed in the uterus to prevent pregnancy, but scientists do not know precisely how they achieve their effect.
The American College of Obstetricians and Gynecologists said it was taking the new report seriously "because it appears to be good solid work and it appeared in a very good journal," said Dr. Harold Kaminetzky, an official of the group in Washington.
A committee will begin evaluating the report this week. "If the argument made is true, it will have profound significance on the use of IUDs in general," said Kaminetzky, whose group publishes Obstetrics and Gynecology, the journal in which reports of the original study appeared.
The latest report, using the raw data from the original study of more than a decade ago, was supervised by a researcher who had been a consultant to the Dalkon Shield's manufacturer, A.H. Robins Co. of Richmond, Va.
The researcher said in an interview that he waited all these years to respond to the original study because he was concerned he would be seen as biased in favor of A.H. Robins, as though "they had hired me to write this paper," and thus his statements "would not get a fair reading from scientists." He also said he was reluctant to publish while lawsuits concerning the shield were still going on.
In response to the newest study, the authors of the original research, known as the Women's Health Study, defended their work as valid.
The Women's Health Study, published in 1981, played a central role in the litigation that led A.H. Robins to seek protection under federal bankruptcy laws. The Women's Health Study was also cited in litigation against manufacturers of other intrauterine devices, leading them to withdraw most such devices from the American market and to reduce research in contraception.
A $2.5 billion trust fund, meant to compensate more than 100,000 women who have sought damages for health problems they attributed to use of the Dalkon Shield, was created when A.H. Robins was acquired by its present parent, American Home Products Corp. of New York. The new study could have some effect on the nearly 100,000 claims still being made on the trust fund, lawyers said.
by CNB