By Marc Kaufman
Washington Post Staff Writer
Wednesday, May 17, 2006
Opponents of the abortion pill RU-486 are mounting a renewed campaign to force the Food and Drug Administration to pull the drug from the market, arguing that it has proved to be unexpectedly dangerous to women.
The effort focuses on the deaths in recent years of four to eight young women who had taken the medication, and especially the four deaths that involved a common but rarely fatal bacterium, Clostridium sordelli . A congressional subcommittee has scheduled a hearing today on what it called "the unsafe characteristics of RU-486."
But research into those lethal infections has unearthed new information that makes it less clear that complications from the abortion pill, sold as Mifeprex, caused the deaths.
The FDA and the Centers for Disease Control and Prevention have implicated the clostridium bacterium in the deaths of more than a dozen other women after childbirth or miscarriage -- making it unclear whether there is a cause-and-effect relationship between the abortion pill and the infections.
"We think it's premature to say there is any direct relationship between [RU-486] and these clostridium deaths," said Sandra Kweder, deputy director of the FDA's Office of New Drugs. "The situation is far more complicated than we originally imagined, and far more broad than anything limited to this drug."
Nonetheless, opponents of abortion and the abortion pill say the risk of clostridium infection after medical abortions warrants immediate withdrawal of the drug. Today's hearing before the House Government Reform subcommittee on Criminal Justice, Drug Policy and Human Resources, chaired by Rep. Mark Edward Souder (R-Ind.), is intended to highlight the drug's alleged dangers.
"Considering the evidence we have of deaths and serious side effects, the maker of this drug should have taken it off the market long ago," said Michelle Gress, counsel to the subcommittee and spokeswoman for Souder. "Since they have not, that leaves it up to the FDA to act, and we want to see what they've done and what they haven't done, and why."
Souder is one of 83 co-sponsors of a bill that would force the drug off the market. Called Holly's Law -- after Holly Patterson, an 18-year-old California woman who died of a virulent infection after using Mifeprex -- the legislation has a companion bill in the Senate.
RU-486 was approved by the FDA in 2000 for medical abortions for women pregnant as long as 49 days. The drug blocks production of the hormone progesterone, which nourishes the fetus, and, when the drug is taken in conjunction with a medication that induces contractions, an abortion results.
Abortion rights advocates welcomed the long-awaited approval of the drug -- in the last days of the Clinton administration -- as a way to make abortion services more broadly available, especially to women in areas where there are few, if any, abortion providers. The maker of Mifeprex, Danco Laboratories, says that about 575,000 U.S. women have used the drug since its approval, and that millions more have used it worldwide.
Within the first few years of Mifeprex's use, complications with it led to a number of FDA warnings and the announcement late last year that four U.S. women had died after taking the drug. That led Souder to write to the FDA for additional information about the deaths and other adverse reactions.
In the committee's briefing paper, the staff wrote that "the FDA has acknowledged the deaths of eight women associated with the drug, nine life-threatening incidents, 232 hospitalizations, 116 blood transfusions, and 88 cases of infection. These and other cases have added up to a total of 950 adverse event reports as of March 31, 2006."
As a possible explanation for some harmful side effects, National Institutes of Health investigator Esther Sternberg reported at a recent CDC-FDA meeting on clostridium that the immune systems of rats exposed to RU-486 were badly compromised, suggesting that the same might be happening with women.
Opponents of RU-486 point to the numbers and Sternberg's theory as indications that the drug is unusually dangerous. But Susan F. Wood, former director of the FDA's Office of Women's Health, said they tell a different story.
"The deaths are clearly serious and tragic, but the overall rate of adverse reactions is actually low," said Wood, who is to testify at today's hearing. She said that although serious side effects are often underreported with many drugs, strict reporting requirements required for RU-486 resulted in a full accounting.
The fact that the CDC has identified at least 12 women undergoing miscarriages or childbirth who died from the same clostridium bacteria, she said, indicates that the problem is more widespread than imagined and not limited to users of RU-486.
The RU-486 deaths "are important events that need to be examined," Wood said, "but I believe some people are most interested in trying to identify reasons to pull the drug off the market."
Another scheduled speaker at the hearing is Monty Patterson, father of Holly Patterson. Since she succumbed to a clostridium infection after a medical abortion, her father has pressured federal officials to investigate the risks of RU-486, which he believes should be immediately taken off the market.
"I've been pushing for answers, and there are still many to be given," he said. "I think it's important to look at everything associated with the drug -- how it was approved, whether all the adverse events are being reported, and the science behind its relation to clostridium."
The RU-486 controversy is sometimes confused with the ongoing dispute over Plan B, the "morning after" emergency contraceptive that its manufacturer wants to sell without a prescription. Although RU-486 does cause an abortion, the FDA describes Plan B as a contraceptive that prevents, rather than ends, a pregnancy.