FEBRUARY / MARCH, 1985 - VOLUME 6 - NUMBERS 2 & 3
While the Upjohn Company has been unsuccessfully attempting to get approval for contraceptive use of Depo--Provera in the U.S., it has gone ahead and marketed it in much of the rest of the world. The drug is currently either "approved" or "registered" in at least 80 countries (see box).
A government's approval of Depo--Provera means that the drug has been approved by a health minister who has reviewed information on the drug (often merely information supplied by the drug company). In some countries this approval clears the way for the drug to be distributed by government-subsidized family planning clinics.
Most Third World countries, however, do not have a drug approval process; in those places, the company simply registers the drug shipments with customs. In Mexico, for instance, although the government is currently reserving judgment on approval of Depo-Provera and is not buying any more of the drug for clinic distribution, the drug is still registered, and Upjohn simply sells it directly to pharmacies, where it is freely available (see box, page 11).
Here are glimpses of experiences with Depo-Provera in several countries:
The Role of Population Control Agencies
In most countries, it is through agencies like IPPF and the World Health Organization (WHO) that Depo-Provera is financed and distributed. The U.S. Agency for International Development (AID) is an interesting case unto its own.
AID, which operates under the jurisdiction of the State Department, was set up under the Marshall Plan to support international development and promote U.S. business abroad. Technically, because Upjohn manufactures Depo-Provera in Belgium and Canada, AID could buy the drug from these subsidiaries and supply it abroad. But, because of AID policy-not U.S. law-AID does not buy or promote drugs that have been denied approval in the U.S. However, it does fund programs like IPPF and WHO, which purchase and promote use of the drug.
AID has been involved with the Depo--Provera debate since the mid-1960s, when the contraceptive was being tested in over sixty countries. (In 1971, when the OBGYN Expert Advisory Committee to the FDA was considering the drug, one of the members said that the State Department had been putting pressure on the FDA to approve it because it was necessary in the Third World.)
Throughout the 1970s, it looked as though the FDA would approve the drug. When approval was instead denied in 1978, AID set tip an ad-hoc committee "to review the risks and benefits of DMPA [depot medroxyprogesterone acetate, Depo-Provera's generic name], [and] to advise USAID on appropriate action the agency can take. ..."The committee concluded that in spite of the denial of approval, AID should directly supply Depo--Provera abroad. However, the agency decided not to act on the recommendation, but to await a new decision from the FDA commissioner on the drug.
Organizations and individuals who defend the use of Depo-Provera in Third World countries argue that the risk/benefit analysis there is different than in the U.S. As former IPPF Assistant SecretaryGeneral Fred Sai explained in 1978 Congressional hearings, "You have a situation where mortality related to mere childbirth is at least a hundred fold the mortality rate related to childbirth in this country. [This is] a distinctively different situation which calls for different measures." Dr. Allan Rosenfield, head of the Columbia University Department of Population and Family Health (who also happened to chair the U.S. AID ad-hoc committee on Depo--Provera), apparently agrees. Family health practitioners, he has written, "can more than justify, on ethical grounds, the development of an entirely new set of medical standards for developing countries."
But the Depo-Provera proponents who stress the risks of childbirth in the Third World rarely emphasize the risks of using Depo-Provera in these same countries, where access to routine medical care and long-term follow-up is severely limited. In fact, conditions in the Third Worldinfectious diseases, malnourishment, and lack of sanitary conditions-make women there more vulnerable to Depo-Provera's ill effects. Malnourished women become anemic faster, making heavy menstrual flow more than an inconvenience. Another problem with Depo-Provera in the Third World is its possible effect on breast feeding infants. One Thai study suggests that Depo-Provera in breastmilk lowers children's immunities, making them more sus ceptible to illnesses like diarrheal diseases that kill more than five million children annually.
In addition, if more funds were put into prenatal care, nutrition, and programs to improve health in developing countries, the number of deaths from childbirth would decrease-and there would be less justification for using a risky contraceptive.
Recognizing these problems, Sweden has reversed the more common double standard approach of pushing Depo--Provera in Third World countries. The government approved the drug for use within its own borders, but since 1980 the Swedish International Development Agency (SIDA) has prohibited its shipment to Third World countries. According to SIDA, "The use of Depo-Provera needs continuous medical follow-up by health staff in a well-functioning health system. We know this is lacking in many of SIDA's programme countries. Without a good health infrastructure, there are risks that the clients are not given enough information to make an informed choice of contraceptive method. "
In the U.S., on the other hand, drug companies are pushing for legislation to legitimize the double standard. The bill, sponsored by Senator Orrin Hatch (R-Utah), would allow American or U.S.based multinational drug companies to manufacture and export drugs not approved for use in the U.S. if the drug is approved in a country found to have "an adequate health authority to approve drugs."
The Health Research Group points out the problems of the proposal. "The U.S. has the most stringent drug approval process in the world. The industry's proposal would make American drug companies subject to other countries' less demanding standards. . . . The international practices of the big drug companies have been well documented: drugs are promoted-without adequate warnings of side effects and hazards-for uses not approved in the U.S.; expensive drugs are pushed when cheaper alternatives would be as or more effective: and improper business practices are rampant while enforcement of local laws is minimal. The drug industry's bill would make this critical situation even worse."