Politics & Policy

“Safe” as a Car Accident

RU-486 fallacies.

According to the Time headline last week, a new study finds that the abortion pill RU-486 is “safe.” The only drug approved by the FDA that is designed to end human life, rather than improve it, “doesn’t increase risks” said the Chicago Tribune headline.

These headlines take deception in journalism to a whole new level. During the last Congress, I served as counsel to the House subcommittee on drug policy that investigated the FDA’s approval of RU-486. Anyone who seriously examines the highly irregular approval process and the serious adverse events associated with this drug can only conclude that it poses a deadly danger to women and should be removed from the market.

Following confirmation by the FDA in late 2005 that four women died from a rare bacterial infection after taking RU-486, Congressman Mark Souder, then-chairman of the House Subcommittee on Criminal Justice, Drug Policy and Human Resources, initiated a year-long investigation of how the FDA was handling RU-486 and addressing the adverse events associated with it. The subcommittee gathered thousands of documents from the FDA, conducted dozens of interviews, and held a congressional hearing, “RU-486: Demonstrating a Low Standard for Women’s Health?” Ultimately, the subcommittee published an extensive staff report on the drug, recommending its immediate removal from the market.

The report, “FDA and RU-486: Lowering the Standard for Women’s Health summarizes a mountain of evidence about this drug’s serious and unpredictable danger to women, detailing the reasons that the drug should be immediately withdrawn from the market. Here are just some highlights: RU-486 was fraudulently approved; it has caused the deaths of at least eight women (that are known); and it is at least ten times deadlier than its surgical alternative.

RU-486 is actually a two-drug combination that first blocks nutrition from the developing embryo, which kills it, then causes the uterus to contract and expel the contents. It was approved in the waning days of the Clinton presidency under a highly unusual and specialized federal provision called Subpart H, which applies only to drugs that treat “serious or life-threatening illnesses and that provide a meaningful therapeutic benefit” over existing treatments.

RU-486 doesn’t even come close to meeting the Subpart H criteria: a normal pregnancy is not a serious or life-threatening illness (RU-486 is contraindicated for ectopic pregnancies); and surgical alternatives are safer for the mother. In short, FDA violated its own regulations to approve RU-486. (The advocacy group Judicial Watch has a detailed report on the Clinton administration’s drive to approve RU-48; and a Citizens Petition filed against the FDA on behalf of Concerned Women for America, the American Association of Pro-Life Obstetricians and Gynecologists, and Christian Medical Association offers a comprehensive account of the approval violations committed on behalf of RU-486 approval.)

RU-486 has caused a tremendously high rate of adverse events relative to the number of women who have taken the drug. As of last year, when the FDA provided information to the Subcommittee for its investigation, RU-486 had caused the deaths of at least eight women, nine life-threatening incidents, 232 hospitalizations, 116 blood transfusions, and 88 cases of infection. In total, we knew of more than 1070 adverse event cases associated with RU-486, out of only 575,000 prescriptions at most. This is even more alarming in light of the fact that adverse event reporting is notoriously low for any drug, much less a drug associated with abortion, for which reporting is expected to be even lower.

Finally, as explained in detail in The New England Journal of Medicine, RU-486 abortion (sometimes called “medical abortion”) is at least ten times more fatal than its surgical alternative. The figure, based on the most conservative numbers available, compares deaths from RU-486 abortion (a rate of 1 per 100,000) to surgical abortion before eight weeks (a rate of 0.1 per 100,000).

Now, just a few interesting facts about the business and manufacturing of this drug: Danco, the company that imports and distributes RU-486 (under the trade name of Mifeprex), is not a U.S. company, but is based in the Cayman Islands; RU-486 is its only product (making a voluntary withdrawal highly unlikely); and Danco imports RU-486 from that paragon of safe-product production, China.

So what are the options for actually withdrawing this drug from the market? There is a bill in the House that would suspend approval of RU-486 pending a Comptroller General review of the FDA’s initial approval. But approval could be reinstated after a favorable Comptroller General review. The FDA has authority, under a few provisions, for withdrawing a drug unilaterally, such as when a drug cannot be used safely despite restrictions, but it’s highly unlikely the FDA would pursue this course of action. The best current option for withdrawal of RU-486 rests with the Secretary of Health and Human Services, who has “Imminent Hazard” authority to remove a drug from the market under certain criteria (such as the unpredictability and severity of adverse events associated with a drug).

Returning to the mendacious headlines claiming RU-486 is “safe,” the careful reader will note that the study prompting this recent PR blitz lauding the abortion pill was not about the safety of RU-486 as a drug, or even as a form of abortion. The study was a comparison of subsequent pregnancy outcomes among women who had prior abortions, concluding that there was no difference between surgical or medical abortion on the impact on subsequent pregnancy.

However, abortion in general poses some risk to subsequent pregnancy; so to say there is no difference in long-term risk after having a medical versus surgical abortion is like saying there is no difference in long-term risk after getting into a traffic accident in a sedan versus a motorcycle. It ignores the fact that traffic accidents are dangerous, and motorcycle accidents are much more deadly.

–Michelle Gress served as counsel to the House Subcommittee on Criminal Justice, Drug Policy and Human Resources that investigated the FDA’s approval of RU-486. She is currently director of Operations for the Westchester Institute for Ethics and the Human Person.

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