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Natural Consequences

Say, here’s a thought: let’s discourage bad behavior by leaving miscreants to reckon with the natural consequences of their actions. If, for instance, you smash up your car and yourself because you were speeding, or had a few too many before getting behind the wheel, we’ll still try to tidy up your victims, but you’re welcome to bleed out on the highway. If you’re shot holding up a convenience store, no traffic-endangering trip in an ambulance to the ER for you — you’ll think twice if you know you’re likely to be applying pressure to holes in your own gut. And how much more seriously will you take your diet and cardio regimen if you know that you’ll need a certified and up-to-date nutrition and exercise log to get admitted for your heart attack?

Do none of these schemes seem attractive? A bit too draconian, perhaps? As a concession to the tender-minded among us, we could provide some of the help that medicine makes available to these offenders, but just keep a little edge on the process — let’s see if weakness of the will doesn’t respond to a dose of surgery sans anesthesia.

Still no takers? Why do you hate responsibility? Or are you just squeamish? Well, how about this for a plan B: if a 14 year old girl has unprotected intercourse, let’s make it as hard as we can for her to get hold of a safe and effective way to ensure she doesn’t become pregnant. Ah, now I can see eyes starting to light up — there’s an idea that the executive branch of a great nation can really get behind. After all, there is nothing like the specter of having to go through an abortion to make a teenager think twice about having sex. Or, rather, undesired pregnancy and parturition, of course — that’ll really get a girl’s attention.

Since 2003, the FDA has turned its back on the best available scientific advice, looked Congress in the face and lied to it, and shed a distinguished senior professional, all in an effort to keep the world more dangerous for erring girls and young women, apparently trusting that keeping their odds of abortion or motherhood higher will lead to fewer of them going wrong in the first place. (Intuitively plausible as this claim might seem, I feel I must note that the literature seems light in pertinent randomized controlled trials.) The agency’s recent apparent volte-face on the nonprescription “morning after” pill — Barr Pharmaceutical’s “Plan B,” a progestin-based agent believed to prevent fertilization by interfering with ovulation — sparked a good deal of skepticism on the Hill and elsewhere, and, given the FDA’s history of prevarication on this matter, understandably so. Interim director Andrew von Eschenbach has issued an invitation to Barr to show how Plan B will be kept out of the hands of some of those who will need it the most — people who are female, sexually active, younger than 18, and without ready access to doctors — but if he thought he’d thereby smooth the path to his Senate confirmation, he was misadvised. There are far too many loopholes more than suitable for accomplished squirmers, and — particularly given just-released depositions from agency officials testifying to pressure to “appease the administration’s constituents” in its regulatory process — no reason to think that squirming won’t remain the order of the day at the FDA. We could all too easily end up with another confirmed FDA director and still no over-the-counter Plan B for anyone.

The real problem, though, is not whether we can trust the FDA to be reasonable about what constitutes reliable enforcement of the 18-year-old age limit it demands. The problem is why the agency insists on that limit in the first place. The Associated Press reported that ratcheting up the age limit from 16 (Barr’s proposal) is required in order to simplify matters for pharmacists, who are accustomed to restricting tobacco sales to those 18 and older. But the FDA’s own independent advisors overwhelmingly recommended over-the-counter availability without age restriction three years ago.

Our best evidence is that Plan B is a safe, nonabortifacient, and highly time-sensitive drug, that it could halve the incidence of unwanted pregnancies in this country, and that its usefulness won’t be confined to women and girls who happen to be under a physician’s care. If there now is good reason for the FDA to believe that its own advisors were mistaken — that, convened again in 2006, they would reverse themselves, or at least show significant weakening in their consensus — that data needs to be front and center. The rationale that pharmacists are more reliable detectors of who’s 18 than of who’s 16 is so blatantly question-begging that our failure to be outraged by it shows how thoroughly jaded we’ve become about the politicization of science under the current administration. Absent solid, squarely relevant evidence that the advisory panel was flat-out wrong, and even granting that the current invitation to Barr is made in good faith, it’s hard to escape a grim conclusion: the administration has effectively enlisted the FDA in the service of those among its constituents eager to single out young women and girls for a punitive attempt at behavior modification of a sort that they would not dream of directing against felons (I sincerely hope). An accusation of misogyny is a harsh charge to lay at anyone’s door. But actions do have their natural consequences.

Published on: August 8, 2006
Published in: Emerging Biotechnology, Health Care Reform & Policy, Human Reproduction

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