Two new medical reports yesterday recommended that the Food and Drug Administration immediately approve the controversial injectable contraceptive Depo-Provera.
Separate groups of doctors and scientists, both of which included representatives of the federal Centers for Disease Control (CDC), said in two articles in the Journal of the American Medical Association that the drug is apparently safe according to tests so far.
However, Dr. Robert Hoover, environmental epidemiology chief at the government's National Cancer Institute, said he continued to believe that the drug should not be marketed yet because no truly valid studies have been conducted on its health effects. He called the situation "outrageous."
Depo-Provera, which is manufactured by Upjohn and used by more than 10 million women in 80 nations, but was never approved in the United States, has been under fire since some cancers were discovered in the 1970s in test animals to which the drug had been given.
It is a situation, said one of the new reports, where there is "honest disagreement" among scientists, but also "misrepresentation" and "misinterpretation" by some opponents.
Joining in this statement in the AMA Journal were Dr. Allan Rosenfield and Deborah Maine of Columbia University; Dr. Roger Rochat, CDC director of reproductive health; Dr. James Shelton of the federal Agency for International Development (AID), and Dr. Robert Hatcher of Emory University.
They pointed out that advisory committees to the FDA, World Health Organization and AID have all said that the unfavorable animal evidence--cancers in some beagles and monkeys--is unconvincing, and recommended human use.
Rosenfield chaired a recent ad hoc advisory panel for AID, which has been eager to expand use of the drug--effective for three months after injection--in countries undergoing population explosions.
The Rosenfield group conceded yesterday that future cancers in users cannot be ruled out, and there are other possible side effects. But it said: "Reviewing the scientific literature on the risks and benefits . . . we find no reason to deny . . . approval, provided studies of its possible side effects are continued and women use it only after having made an informed choice" between this and other contraceptive methods.
Also in the AMA Journal, a group headed by the CDC's Dr. Arthur Liang--and including scientists from the CDC, Emory, AID and the International Fertility Research Program--describe the drug's use by 5,000 black women at an Atlanta family planning clinic from 1967 to 1976.
After four to 13 years' follow-up of more than half the women, only seven breast cancers, one uterine cancer and one ovarian cancer had been discovered, fewer or no more than would be expected in a group of women who did not take Depo-Provera..
Most of the women took the drug for less than a year, and the report's authors concede that the study may therefore have limited meaning. Still, they conclude, it "indicates there is not likely to be a strong association between Depo-Provera injections and cancer of the breast, uterine corpus or ovary."
In an interview, Hoover--who testified strongly against immediate approval of the drug in hearings early this year--said that the women were observed for too few years, and took the drug for too short a time, to make the study meaningful.
At the CDC, Rochat called Hoover's concerns "valid and legitimate." But, he said, until the drug is approved and marketed in the United States and given closer scientific scrutiny, "we'll never be able to do the kind of studies both he and we would like." Compared with other drugs, he said, evidence now justifies approval of use in humans.