AUGUST 1980 - VOLUME 1 - NUMBER 7
Contraceptive Draws FireDepo-Provera, an injectable contraceptive produced by the Upjohn company, continues to be the subject of controversy. Questions remain about its safety, reports pile up about deceitful distributing techniques, and Upjohn and the Agency for International Development press for wider use of the drug.
By Krystyna von Henneberg and Matthew Rothschild
The ongoing controversy over the production and distribution of Depo-Provera, a hormonal contraceptive produced by Upjohn Corporation, has in recent months begun to escalate as women's groups and health centers mount an assault on the use of the drug.
The conflict centers on the means used by Upjohn and multilateral development agencies to promote and administer a drug that a variety of medical studies have linked to a wide range of health hazards. Critics charge that Depo-Provera is being distributed often without informed consent or proper medical facilities.
Depo-Provera is a highly effective and particularly long-lasting contraceptive that is administered by intramuscular injection. One shot provides protection against pregnancy for at least three months. But its side-effects diminish, and some say outweigh, these apparent advantages.
In the short-run, Depo-Provera can cause heavy bleeding, weight gain, decreased libido, headaches, nervousness and depression. The long-run risks, still under investigation, may include infertility, diabetes, and breast, cervical and endometrial cancer. Depo-Provera might also harm children of women who use it. When given to women in early pregnancy, the drug appears to increase the chances of birth defects, and when administered to lactating women, Depo-Provera may interfere with immunoglobins in mother's milk.
The Depo-Provera issue presents a tragic set of trade-offs to many Third World women, who face the cruel choice between the hazards of birth control and unwanted children in families already at the margins of existence. Most supporters of Depo-Provera recognize that such trade-offs exist, but at the same time they tend to discount the long-term and severe risks that Depo-Provera may carry.
Controversy has surrounded Depo-Povera from the moment of its first production as a contraceptive nearly 20 years ago. The current heightened furor reflects a combination of factors. First, sales of the drug are booming; according to Upjohn officials, approximately 10 million women have received injections of the contraceptive. In addition, the feminist movement, both in the U.S. and abroad, has made Depo-Provera a focal point of its emerging reproductive rights campaign. Third,-the U.S. Food and Drug Administration and the Agency for International Development are considering relaxing restrictions on the use of Depo-Provera.
Finally, and perhaps most importantly, troubling reports are pouring in with increasing frequency from the Third World, indicating that women are often being administered the drug in an ethically, if not medically, irresponsible manner.
Depo-Provera has never been approved for use as a contraceptive in the United States, because the Food and Drug Administration has deemed it too dangerous, citing Upjohn's own clinical tests relating injections of the drug to high incidences of cancer in laboratory animals. However, Depo-Provera is being so used in 82 countries through the sponsorship of the International Planned Parenthood Federation (IPPF), the U.N. Fund for Population Activities and the World Health Organization. Upjohn produces and markets the drug through its Belgium subsidiary, thus skirting U.S. government laws prohibiting the export of drugs for uses which are not approved in the U.S.
Recent eyewitness accounts from all over the Third World have seriously questioned whether recipients of Depo-Provera recognize the drug's potential side-effects. "Patients who are administered the drug are for the most part , completely unawake of its dangers," says Viluny Diskin, graduate researcher at Harvard University's School of Public Health. At one Mexican clinic, Diskin saw for herself that doctors administering Depo-Provera didn't tell the women that there would be intermittent bleeding, or that there might be severe cramps, or potential long-term hazards. "When the women returned to the clinic with complaints many of them scared, annoyed, angry they were told that their reactions were very normal," says Diskin.
Similar allegations have come infrom Kenya, Egypt, Botswana. Morocco, Sri Lanka, Bangladesh. Thailand, as well as industrialized countries such as New Zealand, testifying to the biased and scanty information provided to patients.
Moreover, Depo-Provera evidently reaches pregnant or lactating women, for whom it is entirely inappropriate. According to Judy Greenberg of the International Rescue Committee, who recently returned from Thailand working as a midwife in a Cambodian refugee camp, "Depo is being administered with no examination of the patients' health record, often with nothing more than a crude manual pregnancy test. In the meantime, buses with loudspeakers tell the women that Depo will make their figures look better." Community Based Emergency Relief Services, a family planning program in Thailand, uses Depo-Provera extensively, and in its Special Report of June, 1980, it includes a photograph of "a Khmer nursing mother in Khao-l-Lang receiving the injectable contraceptive, Depo-Provera."
Upjohn, with approximately one percent of its total sales coming from Depo-Provera and with a great potential market available, denies acting irresponsibly. "The company has been open and forthright in making all pertinent scientific information, including animal data, available to the appropriate medical and regulatory leadership," Upjohn declared in a press release last year. However, a 1978 letter from Upjohn's New Zealand General Manager beginning "Dear Doctors and Pharmacists"' suggests otherwise. Nowhere does the Upjohn official mention findings of increased rates of cancer in laboratory animals injected with the drug. In fact, the letter states that Depo-Provera has "no reports of extraordinary medical problems associated with it."
Upjohn may have used less subtle methods to procure sales. From 19711976, Upjohn admitted using over $4 million dollars to secure contracts in 29 Third World countries. In a statement filed with the Securities and Exchange Commission in late 1976, Upjohn reported that the bulk of these funds went "to employees of foreign governments or to persons who appear to have been serving as intermediaries for such employers for the purposes of obtaining sales to government agencies or instrumentalities." Part of Upjohn's money also went for "questionable payments" to "hospital officials." Upjohn did not state which countries were receiving payments; nor did the company reveal the products for which such payments were given.
The International Planned Parenthood Federation (IPPF) and the U.N. Fund for Population Activities-the two largest buyers of the drug-have come under heavy fire for their role in administering Depo-Provera. Stephen Minkin, former UNICEF chief of nutrition in Bangladesh and now leading the anti-Depo-Provera campaign for the National Women's Health Network, says the population agencies "don't know what's going on in the field." Diskin concurs: "The drug is distributed cafeteria-style in many places where the doctor-to-patient ratio is very low, and where adequate monitoring facilities are often virtually nonexistent."
An internal IPPF memo of January 1979 substantiates these charges of negligence. Dr. Pramilla Senanayake, medical program advisor for IPPF, stated in the memo: "We do very little... in terms of monitoring the effects of these contraceptives on their recipients."
Currently, the Depo-Provera controversy is entering a critical phase. Upon Upjohn's request, the Food and Drug Administration has agreed to a "Scientific Board of Inquiry" to investigate and vote on Depo-Provera's possible marketing as a contraceptive in the U.S.
In addition, and perhaps more seriously, the U.S. Agency for International Development is considering offering Depo-Provera in its assistance packages. Up until , now, AID has officially followed a policy of refusing to purchase or distribute Depo-Provera, since the agency has a general in-house rule of making available only those drugs approved; by the FDA for similar use in the U.S.
At present, AID contemplates making a policy exception specifically for Depo-Provera. A newly released study commissioned by AID to investigate the Depo-Provera issue has recommended that AID "make [Depo-Provera] available to nations which request it." "This recommendation holds even if the FDA does not change its present stance ..."the report states. AID's commission recommended no extraordinary precautions for delivery or consumption of the drug. "The panel did not feel that there should be any special distribution channel for this drug . . . [and] did not feel that AID should place restrictions on the use of this drug."
Not everyone on the panel agreed with its findings and recommendations. Dr. William Hansel of the College of Veterinary Medicine at Cornell University dissented, citing the gravity of the clinical tests relating Depo-Provera to cancer in beagle dogs and rhesus monkeys. "When a drug has such big effects on two species, one of which is a primate, that is just too much," Dr. Hansel says. "Counter arguments can always be raised," he adds, "but 1 really don't like all the negative arguments. It seems to me they were all in one direction, and they were overdoing the possibilities that the serious occurrences were the result of chance."
In the meantime, the anti-Depo-Provera campaign is picking up steam. The National Women's Health Network has established a Depo-Provera Registry for women who have received injections in the United States. Although Depo-Provera is not approved for use as a contraceptive in the United States, some doctors have so administered it, obtaining the drug which is approved only for palliative treatment of a fatal disease. The Health Network estimates that 10,000 women have been injected in this way in the United States.
In addition, the Boston Women's Health Collective heads an international mailing of information packets to , doctors, government officials, and prospective consumers of Depo-Provera.
In Britain, where the drug is primarily used on minorities and the poor, a "Ban the Jab" organization has formed "to expose the way in which Depo-Provera has been developed, experimented [with] and used on. : women, often without the prior knowledge and consent of the women involved." A similar campaign has sprung up in New Zealand, under the leadership of Sandra Coney. In Bangladesh, Dr. Zafrullah Chowdhury, head of the internationally-known People's Health Center, has come out strongly against the drug after seeing its effects on some of his patients.
Upjohn and sympathetic multilateral agencies appear set on countering their opponents, leaflet by leaflet if necessary. For instance, at the July International Women's Conference in Copenhagen, after representatives from some women's health organizations raised the issue of Depo-Provera, an AID official distributed a paper extolling the merits of the drug. The 11 - page pamphlet claimed that Depo-Provera has the "known advantages" of bringing on "an actual supportive effect on lactation," and "a decrease in individual unpleasant side-effects (such as nausea, dizziness, and mental depression)."
In spite of such public-relations acts, the anti- Depo-Provera campaign achieved some modest gains at the Copenhagen conference. "We took a little step forward by making contact with many uninformed women in Third World countries where the drug is in use," said Saralee Hamilton of the American Friends' Service Committee.
Whether the efforts to curb Depo-Provera will be successful remains to be seen, but it seems likely that they will at least provide some counterweight to present marketing practices. "We want as wide an audience as possible to have access to the facts about Depo-Provera," comments Stephen Minkin. "Up until now, Upjohn and international health agencies have had complete control over the information flow."