A Food and Drug Administration consultant criticized the Upjohn Co. yesterday for selling an injectable birth control drug to 10 million women around the world without commissioning any scientifically acceptable studies showing that it is safe to use.
Robert N. Hoover, chief of the environmental epidemiology branch at the National Cancer Institute and an FDA consultant, called Upjohn's actions "outrageous" and "unconscionable".
The charge came in the second day of an unusual FDA hearing requested by Upjohn, which is trying to overturn a 1978 ban on the birth control drug so it can be sold in the United States.
The contraceptive, called Depo-Provera, can be injected to last for three months, and is widely used in developing nations where doctors or fertility clinics may not have frequent contact with patients. Upjohn spokesmen said that FDA's ban restricts sales of the product in a number of countries. It is also used in some European nations.
FDA spokesmen said the agency was still opposed to the drug's use as a contraceptive here.
Hoover said yesterday that there was "no relevant information on the health effects of Depo-Provera in humans, even though this drug has been used 20 years in many countries."
He said that if he were a health official in another country and a company sought to market a contraceptive while citing only some early "field trials" done on 50 people years before, "I would be outraged." He said he would "send them back to get the data from those millions of women exposed over 20 years," Hoover told the hearing panel.
Robert J. Temple, acting director of FDA's New Drug Evaluation branch, said Upjohn can attempt to convince the FDA to overturn its ban in three ways: by discrediting the animal studies; by showing "through persuasive human studies that the feared carcinogenic risk is not in fact present; or by showing that some people need the drug desperately despite the possible risks.
"It is our view that Upjohn . . . has not made any of these showings," Temple said.
Hoover testified that scientists judging the issue should consider such factors as whether the drug causes cellular abnormality or cancer in animals; whether this occurs in more than one species; whether its occurs at more than one place in the body; and whether there is a direct relationship between an increase in dosage and increased abnormalities.
"Depo-Provera comes up as a bad actor on all counts," Hoover said.
Both Upjohn spokesmen and FDA spokesmen said that what is needed are carefully controlled studies that follow women who take the drug over a long time. Both agree that no such studies exist, although the World Health Organization is now carrying out one such study.
Hoover cited a number of drugs that appeared to be without severe side effects until such human studies were done, such as the hormone Diethylstilbestyrol, or DES, which causes defects in children of women who take it. The drug was on the market for many years before the effect was discovered.
After the panel of three nongovernment scientists concludes the hearing, it will make a recommendation to FDA Commissioner Arthur Hull Hayes, who will make the final decision.