The Secretary of Health and Human Services has decided to keep Plan B, the emergency contraceptive pill, prescription-only for adolescents under the age of 17. Her reasons:
In her own statement, Ms. Sebelius said, “After careful consideration of the F.D.A. summary review, I have concluded that the data submitted by Teva do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age.” She was referring to Teva Pharmaceuticals, the pill’s maker. She noted that 10 percent of 11-year-old girls can bear children, so they needed to be studied as well.
Let me begin my discussion of why I think this is a preposterous decision by establishing my bona fides. As it happens, contraceptive management for adolescent patients is a subject about which I know a fair amount. Before I entered the real world as a practicing pediatrician, I completed a fellowship in adolescent medicine at a large academic medical center in New York City. I am board-certified in both general pediatrics and adolescent medicine, and during the three years of my fellowship I worked in a clinic that focuses largely on reproductive health.
During my time there, the subject of whether emergency contraception should be made available to anyone without a prescription was a hot-button issue. As part of qualifying for certification from the American Board of Pediatrics, I was required to do an original research project. I combined my interest in advocacy with this requirement, and studied whether patients at our clinic were more likely to use emergency contraception inappropriately or incorrectly the younger they got. My study found that, given over-the-counter access to emergency contraception, the likelihood of using the medication incorrectly or inappropriately did not increase with younger patients.
One of my more salient regrets from my professional life is that I never revised and resubmitted my paper for publication after it was peer-reviewed. My fellowship was over, I was already in practice, and I didn’t need to do the work, so I didn’t. Thus, the paper never got published. While the reviewers wanted some edits in how I stated my conclusions, the methods and results themselves were sound. However, those of you who don’t feel inclined to take my word about a study I never bothered to revise are making an entirely reasonable decision. One thing about the study that made it hard to generalize its findings was the nature of the setting where it was conducted. While our patients could be described as higher risk, and thus more likely to use non-prescription Plan B, they were also more likely to have had contact with a health educator who would have explained how to use it correctly. All that being said, my findings indicated that younger adolescent girls were just as likely to use the medication safely and effectively as older adolescent and young adult women.
Whether or not you think younger adolescents would use the medication right, one thing that is not open to serious question is whether the medication is safe: it is. It is safer than a great many medications that are sold without a prescription, including Tylenol, Benadryl and aspirin. If (as he said when defending the Secretary) the President is worried about selling medications to young girls that may “have an adverse effect,” he should probably start with those. Having dispensed Plan B personally to hundreds of patients, I have never seen a single case of a serious adverse side effect. By way of contrast, I have taken care of at least three cases of near-fatal Tylenol overdose.
Ms. Sebelius’s statement is a canard. Gesturing toward the vanishingly small number of 11-year-old girls who would seek non-prescription emergency contraception (and who, assuming they were genuinely capable of becoming pregnant, have reproductive systems similar to older adolescent girls) is handy way of putting off this politically unpalatable decision until the 17th of Never. Ms. Sebelius surely knows that getting a sufficient number of fertile 11-year-olds to power a high-quality efficacy and safety study is nigh impossible, as would be getting any institutional review board to approve a study of sexually-active 11-year-olds that didn’t also include lots of very complicated safeguards to determine why these girls were sexually active in the first place.
On that note, the whole “11-year-old girl” question is as maddening as it is recurrent. It implies the existence of an indifferent medical establishment that views all sexual activity among adolescents as equally acceptable, and that blithely dispenses contraception to all with no questions asked. This is all stuff and nonsense. I am personally or professionally acquainted with dozens of medical providers who work either mostly or entirely with adolescents, and I cannot think of a single person who would not express grave concern upon meeting an 11-year-old who reported being sexually active. Nobody I know endorses a sexual debut at age 11.
Now, one might argue that allowing emergency contraception to be dispensed to anyone without a prescription means that there might be some small number of sexually-active 11-year-olds who will buy it, and thus will side-step the trip to see a medical provider that would have led to the above concerns being raised. True, some very, very small number of sexually-active 11-year-olds might do this. But using this as an argument presumes that these same 11-year-olds would have availed themselves of a medical visit to obtain it were it not available without one. I call that highly, highly improbable, and a poor reason to keep this medication out of the hands of older adolescents who might benefit from it. Numerous organizations that work for the health and well-being of children and adolescents have endorsed making emergency contraception available without a prescription (one in particular here), and would presumably not do so were there reasonable chance that it would lead to some pernicious effect on the health of pre-teen girls.
Ms. Sebelius’s decision is as nakedly political as any that has come out of Washington in my memory. Festooning it with the trappings of scientific concern is transparently ludicrous. Further, in my humble opinion, this is an incredibly silly decision from even a political perspective. The kind of social conservative voters who want to keep emergency contraception out of the hands of adolescents and would be exercised enough about the issue to change their vote because of it must firstly be incredibly small in number, and almost certainly already have enough reason to vote against Barack Obama that this decision can hardly be expected to change their minds. Conversely, this decision is sure to piss off voters who care about reproductive rights issues for no benefit. Yes, those same voters will probably vote for Obama anyway, but many not be inclined to support him with their time and money, and this just gives more credence to all those memes out there about flagging liberal support for the President.
I can only guess that the administration simply didn’t feel like another headache right now, and decided this one could go. I certainly care far more about this issue than the overwhelming majority of Americans, and no doubt this issue hardly registers with most people at all. While I think it was a dumb decision, it certainly isn’t a grievous one. But it is a depressing reminder that, in more than one area, Obama isn’t quite the improvement from his predecessor that I hoped he would be.