U.S. Study of Abortion Drug Finds It to Be Safe
The first U.S. study of the controversial “French abortion drug,†RU-486, has found the drug highly effective and safe for terminating early pregnancies, laying the groundwork for the widespread use of the drug in this country.
The U.S. Food and Drug Administration has tentatively approved sale of RU-486, commonly known as mefipristone in this country. With the new findings, “it seems that there is now the quite realistic possibility†that the drug will be available to the public “within a year,†said Cory L. Richards, vice president for public policy of the Alan Guttmacher Institute, which does research and formulates policy on reproductive issues.
FDA approval cannot be completed, however, until a manufacturer is selected and the FDA inspects its facilities.
Until recently, the Population Council, which owns the U.S. patent on the drug and undertook the research, has had difficulty finding a company willing to manufacture the drug in the face of boycott threats from antiabortion groups.
But Heather O’Neill, a spokeswoman for the Danco Group, which has received a license for the drug from the Population Council, said a possible manufacturer has been found and sales are expected to begin in 1999.
That prospect underlines the importance of the new study, in which a team headed by Dr. Ann Robbins of the Population Council’s Center for Biomedical Research in New York City treated 2,015 women at 17 medical centers. The team reports in today’s New England Journal of Medicine that a combination of RU-486 and the already approved drug misoprostol was 92% effective in terminating pregnancies when used within the first 49 days after conception.
The findings “confirm in the United States, with our ethnic groups and mix of women, that we have similar results to what was found in European trials,†Robbins said. “This is a safe and effective method for abortion in the United States.â€
According to Richards, it is possible that in the next year “there will be three methods of early abortion available, whereas a couple of years ago, there were none.â€
The other two methods are methotrexate, a cancer drug that is now being studied as an abortifacient, and early surgery, made possible by advances in ultrasound imaging. Surgeons have traditionally waited until the sixth or seventh week of pregnancy, when it is easier to see the fetus, to perform an abortion. With the new techniques, it could be done as soon as two weeks after conception.
One of the big advantages of mefipristone, experts said, is that widespread availability of the drug would make abortion practical in virtually any doctor’s office. Women would no longer have to run the gantlet of abortion protesters at clinics, and women living in rural areas not now served by clinics would have greater access to abortions.
April Holley, a spokeswoman for the National Right to Life Committee, said the organization had not yet seen the study and had no comment on it.
Mefipristone is already in wide use in France, Sweden and Britain, but those countries are facing a supply problem. The drug’s original manufacturer, now known as Hoechst Marion Roussel, stopped making the drug last year and transferred patent rights in Europe to biologist Edouard Sakiz, one of the drug’s developers.
The three countries have enough of the drug to last another year, according to Dr. Beverly Winikoff of the Population Council, which was given the U.S. patent by the company. Sakiz has not yet arranged production facilities in Europe.
Mefipristone is also used in China, which manufactures its own supply but does not export it.
Hoechst Marion Roussel abandoned the drug after threats by abortion opponents to boycott the company’s other drugs, especially a promising new asthma drug called Allegra. Other companies have refused to manufacture it for the same reason.
How It Works
Mefipristone, discovered in France, is a synthetic steroid that makes it difficult for a fertilized egg to adhere to the lining of the uterus. A woman seeking an abortion is given mefipristone on her first visit to a clinic or doctor, then comes back four days later for the second drug, misoprostol, a prostaglandin that triggers uterine contractions.
The drug combination works best early in a pregnancy. Among women who had been pregnant 49 days or less, the efficacy was 92%. Among those pregnant for 50 to 56 days, the rate was 83%, while for those pregnant 57 to 63 days, the rate fell to 77%. All of those periods are well within the first trimester.
The Population Council is currently applying for permission to use the drug in the first 49 days.
The most common side effects of the drug combination were bleeding and cramping, the same effects a woman would experience while having a natural miscarriage. Almost all women in the study experienced these two effects. Some women also suffered nausea, diarrhea and vomiting in the four hours after administration of the misoprostol. No abnormalities were observed in cases in which the drugs did not work and the fetuses came to full term.
The researchers considered the method a failure if a woman initially chose the drugs, but then had a surgical intervention for any reason within 15 days.
The 92% success rate at seven weeks was slightly lower than the 95% to 96% rate observed in European studies. Robbins attributed this discrepancy to surgical intervention by U.S. doctors who were not yet comfortable with the amount of bleeding caused by the medication.
In a routine suction abortion, “neither the doctor nor the patient sees much blood,†said Dr. Carolyn Westhoff of Columbia University, who participated in the trials. With the combination of mefipristone and misoprostol, the blood flow is slightly heavier than during normal menstruation. Physicians unfamiliar with the bleeding were initially more likely to perform a surgical procedure to halt the bleeding.
“Now, we are hardly intervening at all,†Westhoff said. “We know how safe it is and how to answer patients’ questions.â€
Robbins also noted that the success rate was 2% to 3% lower in women who had undergone a prior abortion. That may have lowered the efficacy, because 51% of the women in the U.S. study had already had an abortion, compared with 25% to 27% in European studies.
In a second paper, to be published this summer in a medical journal, Winikoff will report that both physicians and patients were very satisfied with the procedure, even if it failed. “Once a woman has taken the drugs, surgery [if is required] tends to be very easy,†she said. “The medication softens and opens the cervix, and that is the most traumatic part of surgery.â€
Even if the drugs didn’t work for some patients, “it allowed them to have a little bit more control over their bodies and to participate a little more in their care,†Westhoff added.
