New Drug Combination for Abortion Called Safe and Effective
BOSTON (AP) _ The combination of an ulcer medicine and a cancer drug may be as effective as the still-illegal French abortion pill for ending pregnancies at home, a study released today suggests.
If the drugs methotrexate and misoprostol work as well as early research indicates, they could profoundly alter the abortion landscape in the United States.
Even though the two drugs have not been approved for abortion, they can be quietly and legally prescribed by any doctor. That allows women to bypass clinics that have been the main battleground for abortion opponents and end pregnancies without surgery.
``This is an exciting phenomenon because it will provide yet another choice for women,″ said Dr. Richard U. Hausknecht, who conducted the latest study. ``Since there is a paucity of health care providers providing abortions in some parts of the United States, this may have a significant impact.″
But the National Right to Life Committee in Washington feared a harmful mental effect from the procedure, in which the fetus is aborted at home, usually within a day of the second drug being administered by a doctor.
``No one knows the psychological ramifications of a woman seeing her unborn child aborted before her eyes,″ said Laura Echevarria.
A small study published last October in the Journal of the American Medical Association showed the potential of the new two-drug combination. Now a much larger study in this week’s New England Journal of Medicine demonstrates its safety and effectiveness.
Security was increased at the journal’s offices after it received a fax from Operation Rescue leader Randall Terry saying, ``Let Richard Hausknecht and every chemical assassin who follows him be forewarned: when abortion is made illegal again, you will be hunted down and tried for genocide.″
Terry told the Boston Herald the message was not meant as a threat and the response to it was an overreaction. ``They promote child killings and whine when someone confronts them,″ he said. ``Tell them to stop whining.″
Methotrexate, a widely used cancer drug, destabilizes the uterine lining. Misoprostol is an ulcer drug that triggers contractions to expel the fetus.
Hausknecht, a gynecologist at Mount Sinai School of Medicine in New York City, tested the drug combination on women in their first nine weeks of pregnancy.
The combination induced abortions in 171 of 178 pregnant volunteers, or 96 percent. Other studies show that RU-486, the French pill that is not yet legal in this country, is about 95 percent effective.
RU-486 and the new combination have not been compared directly. Neither is likely to work as well as surgical abortion.
The Population Council is testing RU-486 at several hospitals and clinics in this country as a step toward seeking Food and Drug Administration approval. Abortion opponents fiercely oppose introduction of RU-486 and have threatened to boycott any pharmaceutical company that manufactures it.
The pill, also called mifepristone, was developed by the French pharmaceutical firm Roussel Uclaf and has been used in Europe for more than a decade.
Since so few studies about the new two-drug abortion technique have been published, doctors may be vulnerable to malpractice lawsuits if something goes wrong.
``We would urge women and their doctors to use this regimen as part of a controlled clinical trial″ and not do it routinely, said FDA Deputy Commissioner Mary Pendergast.
However, Hausknecht said he knows of several doctors in the United States and Canada, whom he declined to identify, who are helping women abort fetuses this way.
The technique requires two visits to the doctor. On the first, the patient gets an injection of methotrexate. A week later, four misoprostol tablets are placed in the vagina and held in place by a tampon.
Then the patient goes home, and the fetus is usually aborted within 24 hours. The main side effects are bleeding and mild to moderate pain.
Hausknecht said a half-hour counseling session before the abortion is essential. ``The bleeding and cramping can be unpleasant,″ he said. ``They could panic if they don’t know what to expect. I explain it in graphic terms.″
He said none of the women suffered any significant emotional distress or depression as a result of the abortions. They overwhelmingly preferred the medical termination of their pregnancies to surgical abortion.
Dr. Mitchell D. Creinin of Magee-Women’s Hospital in Pittsburgh, who has also tested the two-drug combination, called Hausknecht’s work ``a very important, well-done study.″ But he cautioned that since most of the women were in the very early weeks of pregnancy, when abortions are easiest, it probably overstates the effectiveness of the two-drug combination.
Creinin noted that medical abortions are not as fast or effective as surgical abortions, which work 99 percent of the time.
``There are some women who don’t want to have surgery,″ he said. ``For those women, this is great.″