Study plays down risks of abortion pill

5 who took RU-486 died, but article says chance of fatal infection `low'

December 01, 2005|By JONATHAN D. ROCKOFF | JONATHAN D. ROCKOFF,SUN REPORTER

WASHINGTON -- Government investigators studying the deaths of four California women who took the RU-486 abortion pill played down the risks to other users yesterday and said the fatal infection that caused the deaths wasn't particular to women taking the drug.

In an article in the New England Journal of Medicine, the investigators described the risk of the Clostridium sordellii infection as "low" and said it could occur after a woman has taken the pill, undergone a surgical abortion or given birth.

Their findings angered conservative opponents of the abortion pill who have been urging federal drug regulators to suspend sales as a grave threat to women's health. Liberals, who have become increasingly worried that the Food and Drug Administration might buckle to political pressure and restrict access to the drug, welcomed the report.

Supporters of the abortion pill received an additional boost from an associate editor of the medical journal, who in a companion opinion article emphasized the "small" risk to users.

"Regulators should keep this rare complication in perspective and not overreact to scant data by prematurely foreclosing the only approved medical option for pregnancy termination," wrote Dr. Michael F. Greene, a Harvard Medical School professor of obstetrics, gynecology and reproductive biology.

Greene has criticized the FDA for giving in to conservatives opposed to the "morning after" pill. While the morning-after pill prevents impregnation from taking place, RU-486 terminates an early pregnancy.

Since RU-486 was approved five years ago, more than a half-million women have taken the drug, marketed as Mifeprex. Use of the pill, along with a companion drug taken a few days later, is called a medical abortion because surgery isn't required.

Conservative opponents have seized on the four deaths in California since 2003 -- and a fifth in Canada, in 2001 -- to demand that the FDA order an end to sales.

Dr. Donna J. Harrison, chairwoman of the Mifeprex subcommittee of the American Association of Pro-Life Obstetricians and Gynecologists, blames the deaths on medical abortion.

"When you have five deaths, and they're all the same organism, that's like lightning striking the same place five times," she said.

Harrison, of Berrien Center, Mich., has been reviewing 840 reports of adverse events filed with the FDA. She asserted that the risks from taking the drug are higher than thought because many serious problems go unreported.

Dr. Cynthia Summers, spokeswoman for Danco Laboratories, the manufacturer of Mifeprex, praised the articles for highlighting the relative safety of the regimen.

"Fewer than 2 out of 1,000 women treated with Mifeprex have any adverse event reported to Danco," she said in an e-mail. "The vast majority of these adverse events are not serious, not emergencies and are not unexpected."

Scientists at the Centers for Disease Control and Prevention, along with health officials in California, began their investigation last summer after learning of one death. They identified three other deaths in the United States associated with medical abortion but did not find any others that followed use of the abortion pill.

Some physicians and pill opponents assert that medical abortion caused the fatal infection by weakening the body's immune system. The investigators said in their article that more study was needed to determine whether the procedure caused the deaths or whether some other factor was responsible.

In an interview, Dr. Marc Fischer, one of the authors of the journal article, called the deaths "serious and tragic."

But Greene, a CDC epidemiologist, said that "it's important to put these cases in perspective with the hundreds of thousands of medical abortions."

No other deaths have been found, Fischer said, though the investigation will continue. It will also examine whether the four women who died had other exposures that might have led to the infection, he said.

In response to the deaths, the FDA has issued warnings while making clear the abortion pill has not been identified as the cause.

In an interview, Greene said that the journal published the articles to raise the awareness of doctors and patients, so they could recognize symptoms and treat the infection before it leads to death.

Greene served on a committee that advised the FDA about another drug caught up in the abortion debate, the morning-after pill known as "Plan B," which the agency has delayed approving for over-the-counter sales against the recommendations of the committee and staff.

Of the critics, Greene said, "I bet these are the same guys who don't think women should have the same access to emergency contraception, and emergency contraception would have permitted these women to not have needed these abortions."

jonathan.rockoff@baltsun.com

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