SCIENTIST WHO LEFT THE FDA IN PROTEST OF ITS POLICY
ON THE CONTRACEPTIVE "PLAN B" SAYS THE CASE IS A
"POSTER CHILD" FOR CONCERNS OF POLITICS INTERFERING WITH SCIENCE -- "60 MINUTES" SUNDAY ON CBS
Dr. Susan Wood says foot-dragging at the Food and Drug Administration (FDA) on allowing over-the-counter sales of the emergency contraceptive Plan B is "a poster child" for concerns that conservative politics may be interfering with science in government decision-making. Dr. Wood resigned her post as FDA director of the Office of Women's Health to protest the delays and will appear in a Lesley Stahl report on Plan B to be broadcast on 60 MINUTES Sunday, Nov. 27 (7:00-8:00 PM, ET/PT) on the CBS Television Network.
Dr. Wood says that in failing to decide what to do on Plan B, the FDA ignored her advice and that of her fellow FDA scientists, who recommended the drug be approved for over-the-counter sale. "I think the Plan B decision to cut the scientists out is sort of a poster child of this concern about science and politics," she says. "What I saw was the science being ignored."
The science indicated that the morning-after pill, currently available by prescription, is safe and effective, but only if used within 72 hours of unprotected sex. It can also be used in emergency situations like rape or incest to prevent a pregnancy. But the drug has been labeled an abortion pill by anti-abortion activists -- a claim that Wood and most doctors reject because the pill cannot terminate an established pregnancy. Dr. Wood tells Stahl, "The only connection [Plan B] has with abortion is that it can prevent them by preventing an unintended pregnancy."
Despite that, some anti-abortion rights doctors and pharmacists will not provide Plan B to their patients, even with valid prescriptions. In Stahl's story, one Kentucky pharmacist is seen denying Plan B to a young woman on hidden camera videotape. Stahl confronts the pharmacist, who explains her actions on the basis of her personal beliefs.
The Bush White House asked one anti-abortion rights doctor, Dr. David Hager, to serve on the FDA advisory committee that reviewed Plan B's over-the-counter application, along with two others with similar views. Hager objected to the drug because he felt it could increase risky sexual behavior in teens and subject them to greater risk of disease. But the advisory committee reviewed dozens of studies that did not support Hager's conclusions and voted 23-4 to approve the drug based on studies that said it was safe for all ages.
Despite that vote, the FDA rejected the over-the-counter application. That happened after Dr. Hager filed a "minority report" which he says someone at the FDA asked him to write -- he won't say who. In it, he called for more studies on the use of Plan B by young girls. Many have since accused Hager of letting his religious beliefs influence his vote on Plan B. He denies it to Stahl, despite a speech he gave to a Christian college in Kentucky, excerpted on Sunday's report.
In the speech, Hager says "God has used me to stand in the breach for the cause of the Kingdom," referring to his role in the FDA analysis of Plan B. He goes on to tell the college audience, "I argued it from a scientific perspective and God took that information and he used it through that minority report to influence a decision." Told by Stahl that his speech only fueled the opinion that his religious faith clouded his scientific judgment, Dr. Hager replies, "If the idea�is that a person can't be a person of faith and be a person of science, I strongly disagree with that."
Dr. Wood believes Plan B should be made easily available and treated no differently than other contraceptives. "Are we going to� take condoms behind the counter, make them prescription?" she asks. The choice to use contraception is not one for the government or a doctor to make. "I think most Americans would like to leave those decisions as private decisions," she says.
A second application to sell Plan B over-the-counter has been filed, and again the FDA has postponed a decision, meaning it could be years before the FDA acts on it.