A procession of health officials from Third World nations has asked a House committee to reverse a long-standing U.S. policy and provide their countries with a controversial injectible contraceptive that the Food and Drug Administration has refused to license for use by American women.
"We were flagellated" by "uniform criticism from Africa, Asia, and Latin America" about American refusal to provide the drug, Depo Provera, said Michael Teitelbaum, staff director for the House Select Committee on Population.
The unanticipated request raises a difficult moral issue, and is likely to open a new chapter in the already disputatious history of Depo Provera. Committee chairman James Schever (D-N.Y.) said last week he is planning to hold hearings on Depo Provera.
In 1974, after extensive study and a unanimous recommendation from its scientific advisory committee, FDA announced it was within days of approving Depo Provera for use as a contraceptive.
Then, abruptly, the agency reversed itself when a House committee disclosed that the drug might be linked to cancer of the cervix.
Last month, FDA announced after a four-year review that it had decided not to approve Depo Provera. While it found no conclusive evidence that the drug is dangerous, FDA cited incidents of cancer, irregular bleeding, and possible birth defects, as reasons for its decision.
There is also some question about whether Depo Provera, a long-acting drug that is administered only once every 90 days, retards the return of menstruation after a person stops using it.
In the United States, it is proposed for use only by women who cannot use the pill, or who want no more children. FDA said there are not enough of such women in America to justify the drug's use.
"The cumulative effects have persuaded as that we no longer have the positive risk-benefit ratio that may have existed relative to the drug in 1974," FDA wrote to Depo Provera's manufacturer, Upjohn Co.
Upjohn has appealed FDA's decision. Testimony by health officials from the developing world last month before the House Select Committee on Population may give Upjohn a boost.
Under a rigid policy of the Agency for International Development, the major source of American family planning assistance abroad, contraceptives not considered safe enough for American women may not be sent overseas for use by women in other nations.
AID officials said the policy avoids a double standard that could open the United States to criticism from "demagogues." Health officials who testified at the Population Committee hearings contended AID's reasoning is self-serving, and ignores the fact that Dr. Frederick Sai, a Ghanian official with the International Planned Partestified at the Population Committee hearings contended AID's reasoning is self-serving, and ignores the fact that women in developing countries are far more likely to die in childbirth than are Western women.
"The U.S. may not use this drug because it does not need it," testified Dr. Frederick Sai, a Ghanian official with the International Planned Parenthood Federation (IPPF). "It does not have the niche within the U.S. that clearly demonstrates the need. We have a clearly demonstrated need, and we have enough scientists to be able to assess the scientific evidence. Let us use the drug."
'Because 66 percent of our population live under one roof - father, mother, daughter-in-law, son-in-law, and grandchildren - there is hardly any privacy for using pills or condoms or any other methods of that type," said Dr. M. A. Sattar, director of family planning programs for Bangladesh.
"There they want simple, quick, cheap and reliable family planning methods like injectibles - Depo Provera - or menstrual regulation when a pregnancy occurs against their wish, or sterilization."
The United States is not the only manufacturer of Depo Provera, but officials said most Third World countries cannot afford to purchase the drug in sufficient quantities to make it a significant factor in their family planning.
"If AID cannot provide Depo Provera, in effect you are denying it," testified Carrie Lorenzana, a Filipino official for Family Planning International Assistance.
An Upjohn spokesman said Depo Provera has been used for more than six million woman-years in England and other countries around the world.
IPPA chairman Jill Sheffield said her organization is the world's largest supplier of Depo Provera, spending about $400,000 a year in 12 countries which permit use of the contraceptive.
AID officials, even those who strongly challenge FDA's decision, said they do not favor sending Depo Provera abroad as long as it is not licensed for American use.
The Third World officials' argument that woman in foreign countries face a greater risk of pregnancy than American women do, said AID's assistant administrator, Sander Levin, "misses a moral issue - the responsibility of this country not to be any kind of a motivating force in anything that would threaten the lives of innocent human beings.
"It's a tighter bind if another government requests Depo, but I'm still worried about a double standard-first-class health care here, and second-class abroad," Levin said.
Levin said he favors Scheuer's proposal to hold hearings on the drug, in hopes they will lead to a reversal of [TEXT OMITTED FROM SOURCE]
The committee is likely to encounter the same problem FDA did - a conflict between different scientists evaluating data on Depo Provera.
The first indications Depo Provera might be linked to cervical cancer came in 1970, when tumors developed in the breasts of beagles treated with the drug.
"This is a tyranny of the beagle dog," charged R.T. Ravenvolt, AID's director of family planning. "There is no substantial evidence that it is unsafe for American women."
"A spokesman for FDA, however, commenting on four years of study, said the agency is convinced that "the risks of Depo Provera do not out-weigh the benefits."