New Use for Abortion Pill Unlikely To Speed Access in United States
DANIEL Q. HANEY
Oct. 08, 1992
BOSTON (AP) _ The discovery that the French abortion pill is also a highly effective morning-after contraceptive is unlikely to bring the treatment any closer to availability in the United States, experts said Thursday.
A study in Thursday's New England Journal of Medicine found the pill RU-486 completely effective in preventing pregnancy when women took it within three days of having unprotected intercourse.
This represents an entirely new use for the pill, which until now has been approved in a few countries to induce abortions early in pregnancy. However, physicians, stock analysts and others interested in the pill say they doubt its maker will seek approval for it in the United States any time soon.
Anti-abortion groups said they considered RU-486 to be an abortive agent if used immediately after intercourse to prevent the development of a fertilized egg.
''Basically, pharmaceutical companies are reluctant to conduct research on abortion and to market these products in this country,'' said Dr. Irving Spitz of the Population Council. ''There are issues of liability, a lack of financial incentive and opposition from highly conservative organizations.''
RU-486 is made by Roussel-Uclaf, a French subsidiary of the German drug firm Hoechst AG. It has not asked permission from the Food and Drug Administration to sell the drug in the United States.
Dr. Andre Ullman, the company's medical director, was traveling Thursday and could not be reached for comment. However, the company has said repeatedly it will not sell the medicine in any country with wide hostility to abortion.
In New York, analyst Hans Christian Haas of ABD Securities predicted the company ''will wait for the government to make a move to encourage them to file for approval. It's more or less a political issue.''
He and others also said the company is unwilling to leave itself open to boycotts and other actions by anti-abortion groups if it asks approval to sell RU-486.
Whether the drug might someday be approved for other medical conditions is less clear. Gary Fendler, an FDA spokesman, said the agency has approved 19 requests for experimental use of the drug against a variety of diseases. He said Roussel-Uclaf is cooperating with these studies by supplying the drug.
However, some said they believe the company will be reluctant to try to get approval to sell the drug even for conditions that have nothing to do with pregnancy.
''I don't think they'll come close to asking for any indication,'' or use, of the drug in the United States, said Samuel Isaly, an analyst at Mehta & Isaly in New York. ''And if they do, they will be repelled by those who do not believe abortion is right. They will chain themselves to the gates of the FDA and everything else.''
However, Richard Glasow of the National Right to Life Committee said he knows of no groups that oppose testing RU-486 for conditions other than abortion.
Preventing childbirth is only one possible use of RU-486. Several experts said they are intrigued by the possibility that the drug's main action, blocking the the body's production of the hormone progesterone, might help them treat a variety of diseases, including endometriosis, depression, glaucoma, adrenal cancer and AIDS.
Dr. William Regelson, a cancer specialist at the Medical College of Virginia, said he and other U.S. researchers have tried in vain to persuade Roussel-Uclaf to pay for studies of RU-486's potential use against breast cancer.
''It is too controversial for them to get involved in the United States, and I understand their position,'' he said. ''The right-to-life people have sworn they will stop it in any way they can.''
The FDA also has approved the use on RU-486 on a case-by-case basis for people suffering from conditions that might be relieved by the drug. However, the drug cannot be routinely prescribed unless its maker wins agency approval to sell it in the United States.
The drug is on the FDA's ''import alert'' list, which directs customs agents to seize small quantities of the medicine brought into the United States for personal use. The agency contends the medicine could be hazardous if used without a physician's supervision.
Last July, a pregnant California woman tried to bring RU-486 into the country to test the prohibition. Customs agents seized the pills at Kennedy International Airport, and the Supreme Court declined to order the government to return the medicine.