A Public Participation Forum for the FDA Center for Tobacco Products and its Federal Advisory Committee (TPSAC)

For the first time ever, a Secretary of the Department of Health & Human Services has overturned a Food and Drug Administration drug approval.Secretary Kathleen Sebelius overturned the FDA’s recent approval for over-the-counter use of Plan B One-Step for girls 16-years-of-age and younger.

In “dueling press releases” by Sebelius and FDA Commissioner Margaret Hamburg, the latter cited studies showing Plan B safety below the age of 16, while Sebelius claimed insufficient testing in 11-year-old girls, of whom 10 percent are capable of becoming pregnant.

Many people are crying foul, wondering whether the Obama administration is appealing to centrist voters and smoothing over turmoil with Catholic bishops about requiring health insurance to provide contraceptives without co-pays.

What seems clear is that politics influenced Sebelius’s decision, even while she appealed to a scientific rationale, inadequate testing in 11 year-olds. (We leave aside moral questions of finding 11-year-old pregnant girls and aborting their pregnancies for the purposes of science.) It is, of course, quite convenient that, by the time any studies are done, the election will be over.

Science cannot be unlinked from politics; the two have always been inter-related. As Francis Bacon noted, science is always directed at the social/political world, “to relieve the human estate.”

Bacon served as Lord Chancellor of Britain, and was a life-long political operative. From funding choices (HIV vs. breast cancer) to the dawn of the space age (the race to the moon), science and politics are twins born of core human interests.

Consider also the politics of smoking and sex. Every state bans the sale of tobacco products to underage children. Advertisers are forbidden to market products to children, banning cartoon characters, such as Joe Camel.

Further, retailers are obliged to remove tobacco products from the clear view of children. Impressionable children are protected from perceived inappropriate decisions that might harm their health interests.

In contrast, there are growing calls for easy access to contraceptives for children without parental permission, and a burgeoning literature from some circles that encourages children to engage in sexual experimentation.

Yet, numerous studies demonstrate the dangers of high-risk sexual activity among teenagers, such as STDs and virally mediated diseases, including HIV and HPV-related cancers.

Why protect adolescents from tobacco, while failing to protect them from the myriad of health risks associated with high-risk sexual activity?

Adolescents are not generally mature decision-makers. A significant body of neurobiological evidence suggests that the adolescent brain is not fully developed in its cognitive and affective capacities.

Executive functions slowly develop during adolescence. In emotional charged situations (such as sex), the more mature emotion centers of the brain dominate the less mature rational control system.

Consequently, adolescents and late teens are very routinely driven to make more risky decisions given the emotional context.

If all we cared about was scientific data, policy would discourage both underage smoking and underage sexual activity. We would obviously require prescriptions for Plan B One-Step for minors and parental consent to encourage responsible adult-directed decision-making.

The point here is to draw attention to the fact that politics has always influenced the scientific questions asked by researchers, the studies funded by the NIH, how we reason to conclusions and how we interpret scientific data. It seems obvious that Sebelius has made a politically calculated judgment.

An honest understanding of the relationship between politics and science reveals that the two are deeply intertwined. Obama’s aspirational statement in his inaugural address, that he would “restore science to its rightful place,” should be seen as his administration’s implicit recognition that science always will be fraught with politics.

Sebellius’s decision proves that point.

Jeffrey P. Bishop, Ph.D., is author of The Anticipatory Corpse: Medicine, Power, and the Care of the Dying. Mark J. Cherry, Ph.D, is author of Kidney For Sale By Owner: Human Organs, Transplantation, and the Market.