Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: TUESDAY, April 16, 1991 TAG: 9104160301
SECTION: NATIONAL/INTERNATIONAL PAGE: A1 EDITION: STATE
SOURCE: The New York Times
DATELINE: LENGTH: Medium
An unfortunate result of the Dalkon Shield story has been a narrowed choice of contraception for American women and a decline in the research to develop new methods of family planning.
A report last year from the National Research Council and the Institute of Medicine in Washington stressed the need for new contraceptive methods because those on the market are not well-suited to the religious, social, economic or health circumstances of many Americans.
Further, because women remain fertile for 35 years and men longer, contraceptive methods appropriate at one stage of life may not be at another.
Nursing mothers, teen-agers and older women may have differing contraception needs, and many women cannot use some contraceptive methods like the birth control pill because they have high blood pressure or diabetes, or they smoke. New contraceptives for men are also a goal.
But the U.S. legal system has slowed the development and marketing of new contraceptives, the report said. Loss of consumer acceptance of IUDs has led many manufacturers to abandon research in contraceptives.
"Without changes in the product liability rules and procedures, it appears likely that even fewer firms will allocate even fewer resources to contraceptive research and development," the report said.
Perhaps the biggest price of the IUD litigation is the number of unintended pregnancies, which also carry risks of illness and death.
By one estimate, the lack of IUDs will lead 160,000 American women to have unintended pregnancies each year. More than half will elect to have an abortion.
The report urged that liability for contraceptive products be preserved. But it urged Congress to pass legislation recognizing the importance of the careful review the Food and Drug Administration performs before it licenses a drug or device.
In effect, the National Research Council said, the FDA's review process is a quality control mechanism that should protect the manufacturer.
Nevertheless, experts have faulted as inadequate the FDA's surveillance system, which is aimed at detecting problems after a contraceptive product is marketed.
The FDA's authority over the marketing of devices has changed from 1971, when the Dalkon Shield was introduced, based on research data that were so skimpy and flawed that it is highly unlikely that it would lead to approval today.
Although many experts believe the Dalkon Shield was faulty in its design, they say the defect in one device does not necessarily apply to other IUDs.
Shortly after the Dalkon Shield was introduced, doctors began reporting life-threatening infections among users. Experts did not know whether the device caused the infections or whether the women had independently developed sexually transmitted infections.
Beginning in 1976, federal health officials sponsored the Women's Health Study to evaluate the risks of pelvic infection developing among women who used IUDs.
Lawyers for women who contended they had been harmed by the Dalkon Shield said data from the studies played a central role in the litigation against the device's manufacturer, A.H. Robins of Richmond.
Douglas E. Bragg, a lawyer in Denver who has represented more than a dozen plaintiffs, said the studies were among the most important evidence in the litigation because they were government-sponsored, involved several medical centers and were considered carefully designed.
Although the studies "certainly were a strong piece of evidence in support of our cases," Bragg said, he won two cases before they were completed.
Now a team headed by Dr. Richard A. Kronmal, a biostatistician at the University of Washington in Seattle, has raised serious questions about the methodology used in the Women's Health Study, which found a 60 percent increased risk of pelvic infection among IUD users.
Two of the three authors of the study, Kronmal and Dr. Stephen Mumford, were consultants to A.H. Robins. The Dalkon Shield problem led to the removal of other IUDs from the market, even though the FDA did not raise questions about their safety and very few successful lawsuits had been brought against manufacturers other than A.H. Robins.
At a recent meeting in Finland, Dr. Sheldon Segal, an expert in contraception, said he was struck by displays of more than a dozen different types of IUDs that were marketed outside the United States. Only two IUDs are now approved for use in the United States.
Many American doctors are surprised at the extent of use of IUDs in other countries. Dr. Harold Kaminetzky, an official of the American College of Obstetricians and Gynecologists in Washington, attributed that in part to the provincialism of American medicine.
by CNB