Take politics out of science

Last May, the Food and Drug Administration rejected an application by a drug company to sell an emergency contraceptive without a prescription. Against the advice of his own scientists, acting FDA Director Steven Galson said Barr Pharmaceuticals had not sufficiently supported its contention that women under the age of 16 could safely use the product, called Plan B. He also stated that Barr’s application to limit over-the-counter sales to customers 16 years and older was inadequate.

Barr has reworked and resubmitted its application and expects to hear from the FDA this month. In the meantime, the most comprehensive study on the topic was reported this week in the Journal of the American Medical Association and it debunks the fear that ready access to emergency contraceptives, often called morning-after pills, increases the likelihood that young women will engage in risky sex.

Social conservatives have used the risky-sex argument to combat any move to increase access to emergency contraceptives. Only six states, including Washington, allow such pills to be sold without a doctor’s prescription. Thirty-one countries allow over-the-counter sales.

When the FDA turned down Barr’s initial application, Wendy Wright of Concerned Women of America applauded the decision, saying, “Morning-after pill proponents treat women like sex machines.”

But the new study in JAMA found that the sex habits of women ages 15 to 24 were unchanged when they had ready access to emergency contraceptives. Study groups were randomly assigned pills from three sources – a clinic, nearby pharmacies without a prescription and pre-stocked supplies in their homes. Rates of unprotected sex and sexually transmitted diseases were the same in all three groups. The surprising finding was that pregnancy rates for those women supplied in advance were the same as the other two groups.

None of the groups used the pills as often as researchers thought they would. That’s a phenomenon that could be turned around with increased education, but it should not be a factor in the FDA’s decision on access. The agency is supposed to base its decisions on science, not politics and sociology.

But, of course, politics is the hold-up. A conservative administration does not want to be seen as promoting promiscuity, even if that claim has been refuted. But it can approve over-the-counter-sales with another conservative argument: a reduction in unwanted pregnancies means a reduction in abortions.

The FDA’s role is to assure that drugs are safe and effective. Its worry that young women will misuse the contraceptives looks specious when you consider that just about all drugs sitting on grocers’ shelves can be dangerous if used incorrectly. The fact that this drug maker has to clear an extra hurdle in trying to assuage that fear is evidence that this is about politics not science.