The term "orphan drug" usually denotes a drug found to be effective against a rare disease. Since the potential market, and profit, are so small, the manufacturer elects not to distribute the drug. The new French drug RU-486 is also an "orphan drug," although it is effective in treating a very common condition: pregnancy. But it has been orphaned by politics, not unprofitability.
The most frequent means of elective abortion in the United States is suction curettage. In this simple procedure, the cervix--the entrance into the uterus--is stretched open to a small diameter, and the contents of the uterus are removed by suction through a small plastic tube. This procedure has been found to be extremely safe and effective, but no substantial improvement in the technology of early abortion has been made in more than 20 years. Hence, RU-486, or mifepristone, is a development of great importance.
RU-486 is the first of a new class of compounds, the antiprogestins. It is a steroid that blocks the action of the naturally occurring hormone progesterone on the internal lining of the uterus. Since progesterone is required to sustain an early pregnancy, if this support is blocked, the products of conception separate from the uterus and are expelled.
Developed in France, the drug has been used with great success by tens of thousands of French women. Several hundred women in Los Angeles have also taken part in early trials. From 1984 to 1990, volunteers received RU-486 for abortion at Women's Hospital, part of Los Angeles County-USC Medical Center, under research protocols. Our experience with the drug corroborated that of other scientists around the world: RU-486 is safe, effective and popular.
Marketing of RU-486 is anticipated soon in the United Kingdom, and its use in other European nations is expected to follow. The California Medical Assn. and many other medical organizations support the drug. Why, then, is RU-486 not on the horizon for American women? A small but vocal minority opposed to abortion is keeping the drug at bay. Roussel Uclaf, the French manufacturer, appears unwilling to market the drug in the United States until the intensity of the controversy subsides.
Critics of RU-486 seem to have three concerns. Some allege that it is dangerous--the Dalkon Shield of the '90s. Unlike the Dalkon Shield, RU-486 has been rigorously tested by the international scientific community under the auspices of the World Health Organization. The drug is closely related chemically to norethindrone, one of the components of birth-control pills, taken on a daily basis by millions of women in the United States.
In the largest report from France, the rate of serious complications from abortion with RU-486 was one case per thousand abortions. In a recent randomized clinical trial in Los Angeles, we found the side effects of RU-486 to be comparable to those of a placebo, which was an over-the-counter pain pill.
Second, some abortion opponents fear this drug because it could make abortion increasingly private. Abortions with RU-486 might be widely available through physicians' offices rather than through abortion clinics. In that case, opponents of abortion might lose their targets for picketing, harassment and violence. For example, since 1977, 110 abortion clinics have been burned or bombed in this country.
Finally, some abortion opponents claim that RU-486 would promote abortion by making it "too easy." Implicit in this claim is the notion that abortion should be "difficult" or punitive for women, who should suffer for their indiscretion by undergoing both anesthesia and surgery. No mention is ever made of any punishment for the men responsible for these pregnancies.
RU-486, which induces a miscarriage, is apparently not sufficiently noxious. In our trials with RU-486 in Los Angeles, most volunteers had had a prior suction-curettage abortion. These women reported that abortion with RU-486 was "two thousand times better" and "far less violent" than the surgical alternative.
RU-486 has a number of potentially important medical uses aside from abortion. By blocking the action of progesterone, it helps to soften and open the cervix, which may induce labor for childbirth or facilitate surgery inside the uterus. When given in larger doses, RU-486 blocks the action of a hormone made by the adrenal glands. Studies at the National Institutes of Health have shown RU-486 to be effective medical treatment for a serious disease caused by excessive secretion of this hormone. Some breast cancers may also be treatable with RU-486.
For several decades, scientists have known that methotrexate, a highly effective drug used in chemotherapy for certain cancers, could also be used to induce abortion. What would have happened had anti-abortion activists persuaded its manufacturer not to market that drug merely because they disagreed with one potential use? To the extent that politics meddles with medical science, all Americans suffer.