Nobody disputes that Depo-Provera is a highly effective contraceptive. The synthetic version of the female hormone progesterone, Depo-Provera works by blocking ovulation. It needs to be injected only once every three months. And it has a failure rate lower than that of oral contraceptives. But the FDA denied U.S. approval in the 1970s after test beagles on the drug developed breast cancer and two rhesus monkeys developed endometrial cancer. Upjohn contends those findings were not relevant to humans. But a rare FDA Public Board of Inquiry that reviewed Upjohn’s appeal in 1983 criticized many of its studies and found insufficient data to determine Depo-Provera’s long-term risks.
This time Upjohn came armed with evidence from the World Health Organization, showing that women using Depo-Provera in Kenya, Mexico and Thailand had no increased risk of breast, cervical, ovarian or liver cancer; the drug may even prevent some endometrial cancer. But critics note that the WHO study did find a slightly higher risk of breast cancer in young women, as did studies in Costa Rica and New Zealand. A 1991 study in New Zealand also suggests that Depo-Provera may increase the risk of developing osteoporosis.
Depo-Provera is already approved for treating certain kidney and uterine cancers in this country-and nothing legally prevents doctors from prescribing it for unapproved uses. Sharon Camp of the Population Crisis Committee claims that at least 10,000 U.S. women currently use it for contraception-and that she herself has taken it for 13 years. " Like me, these women are satisfied users," she testified. “On behalf of millions of American women who want additional choices, let me put this very bluntly. You, the FDA, have now screwed up three times on this issue. Don’t do it again.” But the National Women’s Health Network countered with reports from hundreds of Depo-Provera users who had reported side effects ranging from prolonged bleeding to depression, weight gain, loss of libido and infertility long after they stopped using the drug.
Proponents argue that women should decide for themselves if such side effects, and the still-unsettled cancer risks, outweigh the benefits of an effective, convenient method of birth control. " There are no perfect contraceptives," said Camp. “Let’s not make the perfect the enemy of the good.” But critics are concerned that poor and illiterate women may not get adequate information to make an informed choice–and they called on the FDA to require consent forms and to keep a registry of users’ long-term health if it does approve the drug. That question now rests with FDA Commissioner David Kessler, who has inherited more than his share of controversial decisions.
