Marketing Abroad

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:

• In India, women's groups are concerned about imminent government approval of the drug. "The government is about to introduce the drug through some women's organizations," says Gayatri Singh, of the Lawyer's Collective in Bombay. "They'll be using it in villages, where people will not be aware of the side effects. Doctors will give vitamin tablets and the [Depo-Provera) injection; people will believe it's a vitamin so they'll take it." The Indian government claims that its approval is based on recently completed Indian studies of Depo-Provera, but will not make the studies public. The Lawyer's Collective is suing the government for failure to release the documents, and is trying to get a court injunction to prevent use of the drug until women's health groups have a chance to review the studies.

• In New Zealand, the Minister of Health estimates that at least 10,000 women receive Depo-Provera annually. According to the women's organization, Campaign Against Depo--, use is concentrated in mental hospitals, maternity homes, family planning and abortion clinics, student health services, and "some particularly enthusiastic `liberal' general practitioners." Upjohn is currently conducting a five-year Depo-Provera study in New Zealand. Philleda Bunkle, of the Campaign Against Depo--, explains, "Upjohn's consultants listed five advantages of doing the study in New Zealand. The first four amounted to the fact that this is one of the few countries which allows Depo-- to be used on white middle class women, and where there is an addition in a public health care system that will pick up the tab."

• In South Africa, the drug is supplied at government-funded family planning clinics. In a single study reviewed by the FDA board, over 19,000 women were given the drug. According to prominent black physician Dr. Nthatlo Motlano, "Agencies are administering Depo-Provera shots to young black girls without even asking their consent."

• In Bangladesh, says British journalist Joseph Hanlon, "The big aid sponsors, especially the World Bank, are putting considerable pressure on Bangladesh to show quick results in its family planning program. In practice that means sterilization and injection, which can be done with little involvement of the women themselves and without setting up a proper family planning and maternal health service."

• In Jamaica, according to a study conducted by Wilma Bailey at the Harvard School of Public Health, in 1963 18 percent of the women receiving Depo-Provera were under 19 years old. By 1975, over 27 percent of the women using the contraceptive were under 19, and over 56 percent were under 24.

• In Thailand, at the Kao-I-Dong refugee camp on the Cambodian border, women have been given a chicken for their families if they agreed to take a shot of Depo--Provera.

• In the Philippines, until recently Depo--Provera use was allowed for "research" purposes only, but it is now approved. Between 10,000 and 15,000 women currently use the drug. Organizations like Population Services in London, the U.S.based World Neighbors, and the International Planned Parenthood Federation (IPPF) all fund private family planning agencies in the Philippines which use Depo--Provera. In addition, the United Nations Fund for Population Activities (UNFPA) supports government family planning agencies promoting the drug.

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.

"Risk/benefit" Arguments

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."