"A Mockery of the FDA's Safety Mandate"

It is estimated that over 15,000 women have used or are currently using DepoProvera in the U.S. Although the problem was more serious in the 1970s, this use continues today. Women get access to Depo-Provera through a loophole in the U.S. drug approval process.

As long as a drug is on the market in the U.S., approved for one use (Depo-Provera is approved as a palliative for endometrial and kidney cancer), a doctor can prescribe it for any other use. According to the Institute for the Study of Medical Ethics, a California-based patients advocacy group, this practice "makes a mockery of the FDA's mandate to make sure that only safe and effective drugs reach our marketplace."

There are several problems with the loophole. In the case of Depo-Provera, the drug is approved to ease the pain of a dying patient. Since the patient already has cancer, the tests that Upjohn must submit to prove the drug's safety and effectiveness for cancer treatment do not have to include long-term cancer studies. But while an unknown cancer risk may not pose a problem for a patient who already has cancer, it can be serious for a healthy woman in search of a safe contraceptive. And although doctors are theoretically vulnerable to malpractice suits if things go wrong, it is extremely difficult for an individual patient to prove that a particular drug, like DepoProvera, later caused a health problem like cancer or reproductive abnormalities.

The problem of doctors prescribing a drug for an unapproved use is exacerbated because the package insert often does not alert the doctor to the problems associated with using the drug that way and in that dosage. In the case of Depo-Provera, which is administered as an injection in the doctor's office, the woman may never see the literature about the drug's risks. And, since technically the drug is not being tested, doctors prescribing it aren't required to give patients informed consent forms.

After a recent Cosmopolitan magazine article mentioned the fact that Depo-Provera has not been approved for contraceptive use by the FDA, the National Women's Health Network received daily requests for further information. "These women are angry that they were given the drug for an unapproved use," says April Pace,. "and that they weren't fully informed by their doctors."

Since 1979, over 800 women have responded to the Network's Depo-Provera registry. Over 90 percent of the women said that they were never informed that the drug lacks FDA approval as a contraceptive. About the same number said they were not told about the drug's potential risks. Half of the respondents had been prescribed the drug for contraceptive use. The other women were given the drug to treat endometriosis or to prevent miscarriage. (The drug has been found ineffective for both uses.) More than half the women complained of effects like irregular bleeding, depression, weight gain, loss of balance, and decreased sex drive.

The Institute for the Study of Medical Ethics also investigated the use of DepoProvera in the U.S. in the 1960s and 1970s. The group interviewed over 150 women in California who were using Depo-Provera or who had recently used it, and conducted a random survey of 50 gynecologists in the greater Los Angeles area, which disclosed that over 30 percent of them were prescribing Depo-Provera for contraception. Over 85 percent of the women who contacted the Institute had not signed a consent form.

"Needless to say, many of the women were outraged that their physician would treat them in such a callous manner," the organization wrote in the findings of its investigation. "The unethical use of DepoProvera is further pointed out by the average age of the women in this survey. Even when the FDA had considered approving the drug in 1974, it was only going to be approved for the limited use on women who wanted no more children. This was due to the possible sterility connected with the drug. Yet the average age among the women who contacted us was 28. Most of these women were in the prime childbearing period of their lives and most of them wanted more children. To illustrate this point, Depo-Provera was given to 16 year old girls in two documented cases and to a 17 year old girl in another case. These girls had certainly not reached a point in their lives when they could say they wanted no more children. "