The Upjohn Company yesterday asked the Food and Drug Administration to reconsider its ban on an injectable three-month birth control drug, allowing it to be sold in the United States.
The drug, used by more than 10 million women in 80 countries in Europe and elsewhere, was banned in the United States in 1978 after studies showed that beagles and monkeys had developed cancer after taking the drug.
The FDA yesterday convened the second special appeal panel in its history to reconsider its ban on Depo-Provera, a contraceptive made from male hormones.
Upjohn asked the panel to ignore the company's own animal studies because neither of the animals used in the tests is a "good model" for determining whether Depo-Provera can cause cancer in humans.
When asked by one of the special panel members what animal might offer a good model, Upjohn research manager Gordon W. Duncan said he could not suggest one.
Instead, he said, more than 10 million women have been taking the drug for up to 15 years, and he said that apparently neither cancer nor other fatal side effects have appeared in medical literature.
Ron H. Gray, an Upjohn consultant, acknowledged in response to questions that no studies have systematically tracked women taking the drug for 15 years or more to determine whether they develop an unusual rate of cancer or other diseases.
Gray said such systematic studies are under way, however, chiefly under the World Health Organization.
Upjohn's Duncan told The Washington Post that, while some scientists believe it is necessary to study humans for 15 or 20 or more years before determining whether a chemical can cause cancer, "we don't know enough" to be sure of that. He suggested that cancers might be expected to begin appearing in four or five years, as has been the case with some other drugs.
Under the rules of the special appeal procedure, three non-government scientists will hear arguments on the issue for four days, and then give a recommendation directly to the FDA commissioner, Arthur Hull Hayes.
In the only previous case in which this special appeal procedure was used, also under the Reagan administration, the scientific panel recommended rejection of Aspartame, an artificial sweetener, because of its health risks.
Hayes ignored the panel's recommendation and approved the sweetener anyway, saying, "I do not think people expect zero risk" from products.
The decision of the FDA commissioner on Depo-Provera will be one with worldwide effect because a number of international organizations, sometimes lined up against U.S. industries, this time will testify in favor of the drug. A number of countries around the world restrict the sale of Depo-Provera because the FDA disapproves it.
But the international organizations feel the drug is especially useful in underdeveloped nations because it can be injected and remain effective for three months. Thus, doctors who see their patients infrequently still can maintain regimens of birth control without depending on their women patients taking a pill each day.
The Upjohn officials, and the scientists they brought in as consultants to testify, yesterday maintained that it is well known that beagle dogs are extremely sensitive animals and develop spontaneous breast tumors quite easily. Therefore, the malignant breast tumors in two of 16 animals tested should not be considered evidence that the drug causes cancer.
Later, Upjohn carried out a 10-year study in 52 rhesus monkeys. Two of the animals developed unusual cancers for rhesus monkeys--cancer of the lining of the uterus. At the time, Upjohn scientists concluded that "the two neoplasms growths were likely related to treatment with Depo-Provera and were not spontaneous lesions."
Yesterday, however, Upjohn spokesmen testified that the disease in the two animals was triggered in a type of cell that does not exist in humans, and therefore no connection can be made to man.
Further, the Upjohn spokesmen said, Depo-Provera is approved by the FDA in the United States for one use--as a treatment for cancer of the uterine lining. This, they said, casts doubt on a study that suggests it can also cause this cancer.
The special hearing continues today.
As the hearing began at FDA, the National Women's Health Network held a news conference to announce that it is preparing a class action suit against Upjohn Company on behalf of American "victims" of Depo-Provera.
The group said that, although the drug is approved only for use as an anti-cancer drug, doctors have been prescribing it for many uses, including as a contraceptive, for years. The women's group said it has so far located about 525 "victims" who have suffered ill effects, ranging from cancer to birth defects, because they were given Depo-Provera and not warned of its dangers.