Abortion opponents are heading to Capitol Hill Wednesday, charging that the U.S. Food and Drug Administration is endangering women’s health by not pulling RU-486 after the deaths of at least five women who took it to terminate their pregnancies.
Drug-safety experts and abortion-rights supporters counter that the pill is safer than many other approved drugs and has not been shown to cause fatal infections. They say banning the pill would be premature.
Nevertheless, opponents have seized on the deaths and other “adverse events” associated with RU-486 as ammunition in their effort to outlaw abortion.
Wendy Wright, president of the conservative Concerned Women for America, said that the FDA has a “lower standard when it comes to women’s health … Death seems to be an acceptable complication when dealing with abortion.”
Wednesday’s congressional hearing was called by Rep. Mark Souder (R-Ind.), an abortion opponent, to “examine the unsafe characteristics of RU-486” and the FDA’s “authority to restrict or withdraw [it].” Anti-abortion forces have been emphasizing the harm abortion inflicts on those who undergo the procedure and portraying themselves as women’s protectors–a role long claimed by the abortion-rights movement. For example, South Dakota’s near-total ban on abortion, signed into law two months ago, is titled the Women’s Health and Human Life Protection Act.
That’s a calculated legal strategy, said Janet Crepps of the Center for Reproductive Rights. South Dakota claims to be protecting women’s health because courts have ruled that abortion can’t be banned based on the argument that the state has an interest in protecting fetal life.
“That’s a bunch of hooey, of course, because they just want to ban abortion,” Crepps said.
Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said the debate over RU-486, also called mifepristone or Mifeprex, is more about politics than safety.
“The ultimate proof of how politicized the debate has become is the number of far more dangerous drugs that are still on the market,” Wolfe said.
“There are 200 accidental deaths a year linked to [the painkiller] Darvon, and it has no unique advantage,” he said. By contrast, “for women in many parts of the country, RU-486 is the only way to terminate a pregnancy” because there is no abortion provider nearby.
Wolfe said the problems with RU-486 “should not be pooh-poohed. But there’s hardly enough for the drug to be taken off the market.”
Dr. Charles Bennett, a drug-safety expert at Northwestern University, agreed. Without a formal risk-benefit analysis, he said, the deaths associated with Mifeprex “would not be enough to make you say this drug should not be on the market. But they would be enough to make you investigate.”
One question, Bennett said, is whether taking the pills intravaginally increases the risk of fatal infection. In all five confirmed deaths associated with medical abortions, women took some pills vaginally. All died of toxic shock induced by Clostridium bacteria within a week.
That’s what happened to Holly Patterson, 18, of California, who had an abortion in 2003. Her father Monty Patterson is backing a bill called “Holly’s Law” that would temporarily ban the drug while its approval process is reviewed.
Patterson is among the witnesses scheduled to appear at Wednesday’s hearing.
The panel also will hear testimony from Dr. Donna Harrison, of the American Association of Pro Life Obstetricians and Gynecologists, who said the drug appears to suppress the immune system and allow certain bacteria to flourish.
Harrison cited a study in which laboratory animals were exposed to bacteria commonly found on the skin. Thirteen percent of the animals died. “But if you pretreat them with mifepristone, 100 percent die,” she said.
Souder’s panel, the Subcommittee on Criminal Justice, Drug Policy and Human Resources of the House Committee on Government Reform, also has invited current and former FDA officials who are expected to be grilled about how the abortion pill won approval in 2000.
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Abortion opponents charge that the agency rushed Mifeprex to the market under pressure from the Clinton administration.
They point out the drug was cleared under a section of the law called Subpart H, which provides for accelerated approval of life-saving treatments.
Dr. Lisa Rarick, who served as director of the FDA’s Division of Reproductive and Urologic Drug Products when Mifeprex was up for approval, said the review took more than four years, about three times longer than average.
Rarick said the agency did not apply the “accelerated approval” provision of Subpart H, but another section that allows the FDA to impose special restrictions.
“In essence, the Subpart H approval was meant to restrict the use of mifepristone,” said Rarick, “not accelerate its availability.”
Anyway, she said, the FDA is actively investigating reports of death and serious side effects associated with Mifeprex.
Drug-safety experts said the decision to ban a drug is typically based on several factors, including the number of adverse events associated with it, how closely the drug is linked to those events, and whether the drug offers any unique benefit.
In 2000, the FDA pulled Lotronex, a remedy for irritable bowel syndrome, after five patients died in the first seven months after its approval. But it was re-approved two years later for extreme cases after patients complained it was the only drug that relieved their symptoms.
Viagra, a popular pill for erectile dysfunction, stayed on the market even after the FDA recorded some 130 deaths of men who had taken the drug in the first eight months after it was approved.
Although there is no evidence that Mifeprex caused the five deaths, they all occurred within a week of the medical abortion in apparently healthy women.
Since nearly 600,000 women have taken the drug since its approval in the U.S., that would suggest a death rate of less than 1 in 100,000 for Mifeprex. That’s about 10 times less than the risk of dying from carrying a pregnancy to term.
The death rate from early-term surgical abortions is estimated to be about 1 in 1 million, prompting abortion opponents to argue that medication-induced abortions are 10 times more dangerous than surgical procedures.
But James Trussell, director of the Office of Population Research at Princeton University, said there is no requirement to report adverse events linked to surgical abortion, as there is for Mifeprex; so the comparison is shaky.
“But even if the risk is 10 times greater,” he said, “it’s 10 times a very small number.”
According to NARAL Pro-Choice America, the adverse reaction rate of Mifeprex is 0.158 percent.
By comparison, the group said, Claritin allergy pills have an adverse reaction rate of at least 12 percent; and Lipitor, a cholesterol-lowering drug, has a rate of more than 10 percent.
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