FDA holds Depo-Provera hearings

Erica Gollub attended the hearings and filed this report.

In 1978, the FDA found the injectable drug too dangerous for use by American women. FDA's decision was based on a study done by Upjohn at the agency's request, which found that rhesus monkeys and beagles injected with the drug developed cancer.

But the agency came under heavy fire from other governmental and private agencies involved in the drug's distribution in the Third World. Led by the Agency for International Development (AID), these groups feared the impact of the FDA decision on the "image" of Depo and family planning programs abroad. They also opposed any constraints on its overseas distribution.

After years of delay, the FDA finally agreed to hearings on the drug. From the beginning, Upjohn insisted on a scientific inquiry, an approach that limited the scope of issues considered - particularly the more significant ethical and policy considerations raised by the use and promotion of the drug. Nevertheless, evidence presented by opponents of the drug showed that Depo-Provera is considerably more dangerous than Upjohn is willing to admit.

Dr. Christopher Rhodes, called to testify by the National Women's Health Network, listed the "constellation of defects" that women can experience, ranging from severe menstrual irregularities to permanent sterility to high blood pressure and blood clots. Sybil Shainwal, president of the Network, accused Upjohn of "risking the health of American women with a drug that has never been proven safe." Public Citizen's Health Research Group charged that "no reliable studies" have been done on the long-term use of Depo on humans.

In defense, Upjohn cited the conclusions of "three international panels of experts" associated with AID and the World Health Organization. These groups claim that animal studies - the basis of nearly all the evidence on Depo - are "inappropriate" for judging the drug's effects on women.

But Steve Minkin, former Chief Officer of Nutrition at AID quoted studies from the Office of Technology Assessment and the National Research Council affirming the reliability of animals in cancer research. Minkin worked with some of the first Depo users in Bangladesh in 1979.

National Women's Health Network witness Dr. Ruth Shearer also disagreed with Upjohn's "experts." A cancer and genetics expert, Shearer charged that the AID and WHO groups "were not impartial panels of concerned scientists. They represent organizations which have been responsible for widespread use of Depo Provera." If they admitted to the hazardous nature of the drug, she said, they "would be admitting their responsibility for future massive human illness."

Another issue raised at the hearings concerned the use of Depo on women whom doctors say cannot be "trusted" with other forms of contraception. Depo critics have charged that the drug has been used on "powerless groups" such as mentally retarded women and welfare mothers. At the hearings, witnesses described two groups recently "targeted" by doctors: the predominantly Hispanic population at University of Southern California Medical Center in Los Angeles, and the "SS-95%" Black population at Grady Memorial Hospital in Atlanta.

According to Dr. Robert Hatcher of Grady, 11,000 women have been treated with Depo at his hospital since 1967. Usage started several years before any animal testing had taken place.

Dr. Sidney Wolfe of the Health Research Group found this double standard of safety "morally offensive and unacceptable." Mentally retarded women, said Wolfe, are "the least appropriate candidates for a contraceptive such as Depo-Provera. (They) are the least likely to be able to weigh the benefits and the risks of the drug and give true informed consent."

But Dr. Hatcher and other family planning practitioners said that their consent form and information booklet accompanying the shot justifies the use of the drug. "Our booklet mentions 11 problems related to Depo-Provera," Hatcher said. He reasoned that as long as women "know" what they're getting, the injection should be used.

Dr. Wolfe, however, pointed out that "the whole question of informed consent is a moot question" since the full extent of risk is still unknown. Another witness cited how the drug is administered at one clinic in northern Thailand, where women "are processed in from 60 to 90 seconds," with little time for "amenities" like consent.

Some population officials used the consent argument to attack the opponents of Depo. Dr. Malcolm Potts of Family Health International said that anti-Depo forces "oppose people having a choice" in contraception. "I see modes of contraception like modes of transportation," said Potts, and compared Depo with a Volkswagon: "It's sturdy, dependable, it might rattle and does have some problems, but it should be available."

But health activists countered that these same "pro-choice" officials spend little time and money promoting the safer, barrier methods of contraception, and often endorse money or food "incentives" for Third World women "choosing injection or sterilization". "Their priority," said one activist, "is expediency in population control.

A number of consumer, women's and human rights groups are mobilizing to stop the spread of Depo-Provera. The National Women's Health Network maintains a registry of women having received unauthorized shots of Depo, which they say circulates in the blood for three months or longer. The Network recently announced their intention to sue Upjohn for compensation to women injured by the drug.

United Presbyterian Church and the Maryknoll Fathers, members of the Interfaith Center on Corporate Responsibility, have recently submitted a shareholder resolution to Upjohn concerning Depo. Other groups working on the issue include Public Citizen's Health Research Group and the Boston Women's Health Book Collective.

Whatever the outcome of the Depo hearings, Upjohn has little to lose and much to gain. FDA approval would mean greater sales for the company on a product whose annual sales already exceed $25 million.

Erica Gollub is a feminist and health activist living in New York City. She has been researching the Depo-Provera issue since 1981.