Plan B needs a plan D, for 'data'

I trust you know what "they" say about opinions: everybody has one. Just like everybody has a ... well, you know what they say.

But when it comes to policies with the potential to impact the health of the population, we should generally aim to do better than opinion. Invariably, I have mine, but I don't consider it a better basis for policy than anybody else's. Instead, my opinion is that opinions aren't good enough to guide policy. Evidence should guide policy. Epidemiology, not ideology. Data, not diatribe.

The particular issue that has my opinions about opinions stirred up at the moment is the recent action by the Department of Health and Human Services regarding morning-after contraception. U.S. Secretary of Health Kathleen Sebelius overruled the FDA and decided to keep "Plan B" accessible to girls younger than 17 by prescription only. The FDA had recommended, in a split vote, to make the agent available over-the-counter without an age cut-off.

This is simply the latest chapter in a long-simmering controversy. So, a bit of history:

In April 2009, in accord with a ruling by a federal judge, the FDA lowered the age requirement for over-the-counter access to Plan B from 18 to 17. And thus Plan B, conceived in controversy, gestated in controversy as well.

In 2005, the controversy was whether to make this last-ditch defense against unintended pregnancy available over the counter (OTC) to anyone. At that time, the product--essentially a concentrated dose of the hormones used in oral contraceptives that prevents implantation, and thus pregnancy, if taken within 72 hours of intercourse--was available by prescription only. Making Plan B available OTC was recommended by a scientific advisory committee to the FDA, the agency's regulatory staff and the head of the agency's drug center.

But instead, the FDA Commissioner at that time announced that a decision on Plan B would be postponed indefinitely while the agency wrestled with the unprecedented policy implications. I believe the real story, however, was all about political opinions infused into what should have been science-based action.

Dr. Susan Wood, who was assistant FDA commissioner and director of the agency's office of women's health at that time, resigned in protest over the agency's handling of the Plan B issue. Dr. Wood contended that abortion politics, rather than science, were behind FDA decisions regarding Plan B, which was rather self-evident to anyone paying attention.

Eventually, Plan B was made available over the counter, but to women 18 and older. With the official lowering of the age restriction to 17 in 2009, Plan B reentered the news and reignited controversy.

Age, in fact, was always the centerpiece of the Plan B controversy, or, as I see it, at least the pseudo-controversy used to stall any action. The FDA acknowledged in 2005 that OTC Plan B was appropriate for those over age 17, but not for anyone younger. The contention then was that it could not be made available over the counter at all without the risk that younger girls would buy it.

But that reasoning would suggest that cigarettes and alcohol should be sold by prescription only, since they, too, come with an age restriction! Yet both are, of course, sold "over the counter." The notion that placing an age restriction on an OTC product had "unprecedented policy implications" was eventually exposed as the nonsense it always was.

But that left us with age-restricted access to Plan B, just a nominally lower cut point. Whether Plan B should have any age limit is a debatable issue in its own right. Personally, I don't think so. Don't get me wrong. I am not advocating sexual licentiousness. As the father of five children, four of whom are young women and teenage girls, I find my views on juvenile sexual activity to be quite conservative!

But it seems self-evident to me that if and when an injudicious sexual encounter does take place, compounding it with a safely preventable, unwanted pregnancy--or an abortion--makes little sense. Plan B is quite safe and very effective, having been used by millions of women in the U.S. and Europe. Once a girl is old enough to decide to have sex, however ill-advised her decision may be, then it seems to me she is old enough to buy and take Plan B. The more portentous of these two decisions is clearly the former, not the latter.

And let's face it: a young girl who ill-advisedly has unprotected sex on Friday night may have some difficulty getting to the pediatrician on Saturday morning.

While long embroiled in the passions and politics of abortion, Plan B is not an early abortion. Immediately after intercourse, there may not even be an egg, let alone a fertilized egg, in the fallopian tube. Plan B can prevent pregnancy if taken between intercourse and ovulation. It works post-ovulation, prior to implantation, as well. This is contraception, just applied a bit late. Earlier contraception is better for many reasons, the most significant of which is that the right kind protects not only against pregnancy, but also against sexually transmitted diseases, including HIV. Plan B does not. That's exactly why it is plan B, and not plan A.

Plan A is either abstinence from sex, or the use of barrier contraception (e.g., condoms) that can safely prevent both pregnancy and sexually transmitted disease. Plan B is just what it should be: a contingency plan when better options are no longer available. Plan B is far from ideal, but once it becomes a relevant consideration, the other options are decidedly less so.

The principal argument I have found against dropping the age restriction for Plan B is that young girls will rely on it as their preferred form of contraception.

While I can generally see the merits on both sides of such arguments, and am respectful of the range in perspectives on ethical matters, I really think this opposition is feeble. It defies reason to think that girls will be sufficiently well informed about Plan B to rely on it for contraception, yet not informed of its clear limitations relative to the better methods of Plan A. Pharmacies that sell Plan B also sell condoms, and at lower cost.

The considerable research on the topic of teen sex indicates that informing young people about sex and its consequences, and empowering them to avoid those consequences, are associated with lower, not higher, rates of sexual activity. Any messaging associated with the marketing of Plan B should be an opportunity to highlight the hazards of unprotected sex.

Which makes a strong case for Plan A. I support Plan A for the prevention of unwanted pregnancies among teenage girls.

But when the chance for Plan A has come and gone, I support the availability of Plan B to any girl old enough to have made the decision that makes contraception a relevant issue in the first place. In moving to plan b for Plan B in 2009, I believe the FDA did the right thing in my opinion. Better still would be the removal of an age restriction altogether.

But that is just opinion, which leads us to Plan D, for data. Studies could readily be conducted in which populations of young girls are given differential access to Plan B, and the outcomes tallied. If the removal of age restriction resulted in no discernible harms, a reduced rate of unintended pregnancy and a reduced rate of abortion, the data would argue strongly for the very action the FDA recently recommended. If, however, the results were contrary, showing net harm, the DHHS action would be defensible as public health science without the taint of political intrusion.

I have an opinion about Plan B. It's that we can, and should, do better than opinion when making decisions that affect health, and have the potential to change the course of lives. So here's to Plan D: getting the data we need to elevate evidence and epidemiology above ideology and the political fray. Here's to the primacy of proof.

Because everyone has an opinion. And you know what they say ...

David L. Katz, MD, FACP, MPH, FACPM, is an internationally renowned authority on nutrition, weight management, and the prevention of chronic disease, and an internationally recognized leader in integrative medicine and patient-centered care. He is a board certified specialist in both Internal Medicine, and Preventive Medicine/Public Health, and Associate Professor (adjunct) in Public Health Practice at the Yale University School of Medicine. He is the Director and founder (1998) of Yale University's Prevention Research Center; Director and founder of the Integrative Medicine Center at Griffin Hospital (2000) in Derby, Conn.; founder and president of the non-profit Turn the Tide Foundation; and formerly the Director of Medical Studies in Public Health at the Yale School of Medicine for eight years. This post originally appeared on his blog at The Huffington Post.

Labels: abortion, contraception, David Katz, FDA, guest post, health policy, lifestyle, women's health

posted by David L. Katz, MD at 9:00 AM