Oklahoma and medical abortion

Really interesting piece from Emily Bazelon on the court challenge to Oklahoma’s law that requires abortion providers to “follow FDA protocol” when administering the drug that induces the abortion.  Well, that sounds reasonable enough until you consider the following:

In general, an FDA protocol is written at the time a drug is approved, based on the available research at the time. After doctors start prescribing a drug, more studies come out, and they may well suggest that a drug has other uses, or can be better administered at a different dose or in a different way.  Doctors keep up with the latest findings and shift based on the accumulating evidence. This is what’s called “off label” use. “It’s perfectly legal and acceptable,” says Susan Wood, a public health professor at George Washington University and former FDA assistant commissioner for women’s health. (She quit over the Bush-era fight about approving the emergency contraception Plan B). “It’s also common in medicine.” The American Medical Association estimates that one-half of all prescriptions written are off-label, Yale medical school professor Nancy Stanwood told me.

When the FDA approved medical abortion in 2000, it was already legal in 18 countries. The standard regimen at the time was a dosage of 600 milligrams of Mifeprex, doled out over three clinic visits, and only to women in the first seven weeks of pregnancy. Since then, research has shown that it’s safe to use 200 milligrams, given at two clinic visits and then at home, for up to nine weeks of pregnancy (Here’s a handy comparative table). TheAmerican College of Obstetrics and the World Health Organization now advise 200 milligrams, given up to nine weeks. According to the brief filed in the Oklahoma case by the Center for Reproductive Rights, “96 percent of all medication abortions now involve an evidence-based regimen that departs from” the FDA protocol that’s on the label.  [emphasis mine]

Regardless of your position on abortion, you should be very concerned with the idea of the government micro-managing medicine to this degree (of course, based on yesterday’s post the need for certain basic regulations is damn clear).  Here’s Bazelon’s conclusion, which I think is exactly right:

But the Oklahoma law, and the likely Supreme Court battle over it, turn on a different question (to which Wood answered with a resounding no): Should states single out Mifiprex for different treatment from any other drug? On a deeper level, should states be in the business of ordering doctors to provide what they believe, based on the best medical evidence, is substandard care? Only in the field of abortion does the government interfere in this way with doctors and their patients. Is that really what the Constitution allows?


About Steve Greene
Professor of Political Science at NC State http://faculty.chass.ncsu.edu/shgreene

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