Selling RU-486 - Food and Drug Administration rushes approval of abortion drug - Editorial

National Review, August 12, 1996 by Clarke D. Forsythe

### FORSYTHE, CLARKE D.

A COUPLE of years ago promoters of RU-486 hired a PR firm to "sell" the drug to the American public. They had four talking points: it will make abortion totally private, make abortion as easy as taking aspirin, replace surgical abortion, and end the abortion controversy in America. It is now clear that none of these is true. In France, the RU-486 procedure involves at least three trips to an abortion clinic (sometimes as many as seven) for medical supervision, necessary because of the potential for substantial blood loss, and for the confirmation of a completed abortion. After multiple trips to the doctor, some women still have to "pass" the dead fetus at home. In 1 to 7 per cent of cases, the woman has to have a surgical abortion after all.

But Food and Drug Administration head David Kessler, under heat from the Clinton Administration, has promised abortion advocates that his agency would approve RU-486 in a fast-track six-month process, and he seems on the verge of delivering. An FDA advisory committee -- including such longtime abortion advocates as Kenneth Ryan, Ezra Davidson, and Edward Wallach -- has recommended that Kessler approve the drug, which he could do as early as mid September. All of this raises the likelihood that the drug will be marketed with major questions still lingering about its safety:

-- What do the researchers make of data showing special risks for African-American women (who have a higher incidence of uterine fibroids and may be at greater risk of incomplete abortion from RU-486), Asian-American women (who may be at greater risk of heavier bleeding), and obese women (whose larger body mass may entail higher rates of failed abortion)?

-- Will the FDA require the use of ultrasound to make sure that a pregnancy is not past seven weeks? Should the FDA be concerned that RU-486 might only injure, and not kill, the developing child?

-- With nearly 43 per cent of abortions now repeat abortions, what are the medical implications from multiple uses of the drug? What will be the effect on a woman's future pregnancies?

Even the clinical trials weren't always credible. At the conclusion of trials in Iowa, the Des Moines Register published a story last fall stating that the "clinical test of the abortion pill has ended in Iowa, with no complications reported among 236 women." Dr. Mark Louviere was surprised to see this account after treating one woman who had been part of the trials. According to the Waterloo Courier, she suffered life-threatening complications caused by loss of half her blood volume after being administered RU-486 at a Des Moines Planned Parenthood clinic. Planned Parenthood explained that its claim of no complications referred to the trials, not the participants.

The participant who always suffers most from RU-486, of course, is the unborn child. If there is something unseemly, and indeed risky, in the FDA's rush to approve this drug, the deepest shame is that an agency charged with protecting Americans' health would give its imprimatur to a drug designed to destroy the most vulnerable segment of our population. This is a procedure of which it can be said without irony that the operation was successful and the patient died.