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.
I agree with our policy conclusion, at least instinctively, and due in no small part I will bet on the influence of my wife’s views on the subject.
I disagree with your political calculation. I think it sends the politically beneficial message “We view adolescent sex and our approach to it as a complicated and nuanced issue,” which is overall helpful (whether it should be or not).
But here is a question I have (perhaps nothing more than a stunning display of my own ignorance): Plan B, as I understand it, generally works the same way that Plan A (“The Pill”) does by preventing ovulation and largely by doing the same thing just in the sense of all-at-once rather than as a daily activity.
With that, what is the rationale for this being OTC but The Pill not being OTC? That is the square I am having a hard time circling. Not enough to change my views, but to make me wonder about our general approach to the things I used to be able to and can get off the shelf and the things I cannot. I don’t really know how the FDA addresses these things, nor do I know how they should. From a doctor’s perspective, I’d love to know your thoughts on this more broadly.
Should everything safer than Tylenol be OTC?
Should The Pill?
What about Sudofed?
Do you see a potential danger in self-medicators taking more dangerous “natural supplements” like ephedra because access to things that are more tested require a trip to the doctor? (This one is of particular interest to me, as more than one doctor – including my wife – has suggested that my tobacco use and previous ephedra use might be a part of a self-medicating pattern.)
You can limit this post to OTC vs The Pill, but I’d love to know your broader thoughts in another post.
In brief, standard oral contraceptive pills (OCPs) should not be OTC because they are much less safe than Plan B. Almost all contain some kind of estrogen, which Plan B does not, and thus have a very different side effect profile. They can increase the risk of blood clots, for example, which the low-dose, progestin-only emergency contraceptive pills do not. Plan B is also incredibly easy to use, whereas there are specific instructions for how to take OCPs, which render them much less effective if not followed.
Thanks for the run-down. I’m sold.
Out of curiosity, given that a lot of the side effects of OCP relate to estrogen, I’m assuming that one that relies solely on progestin and not also estrogen is not available/possible?
I had actually thought of the “specific instructions” part, and was wondering if that was the rationale. The timing requirements would have made me an unreliable OCP taker.
There are actually numerous progestin-only contraceptive methods available. The progestin-only pill (or “mini pill”) has been around forever, but a lot of providers don’t use it (myself included) because it’s a very “fastidious” medication — it has to be taken reliably at the same time every day, without missing a pill, to be effective. There are also injections (Depo-Provera) and implanted devices (Implanon) that are progestin-only. All of them have pluses and minuses, but they’re definitely available.
You just keep exposing all that I don’t know about female contraceptives. I thought all OCP was pretty fastidious. Maybe it’s not a coincidence that I thought most were primarily (or solely) progestin-based and most were fastidious. Maybe that’s what I’ve had (errr, second-hand) exposure to.
Out of curiosity, why does the most say “by: blogsdna” down at the bottom? Did you write this whole thing on a phone?!
While all OCPs require a relatively good degree of compliance to work optimally, the progestin-only pill is particularly fastidious. You really can’t miss a pill at all (or even go off schedule much) without significantly diminishing its efficacy. (I’m ~97% sure about that, but am not entirely sure because I prescribe it so little.)
I haven’t the faintest idea what on earth that means, though I noticed it and wondered myself.
Tylenol is fucking dangerous. It’s “gonna kill you” level is very close to the “therapeutic” level.
It’s the sort of thing that shouldn’t be on the OTC list, because most people think of “pain meds” as something they can take five times the amount, and not get sick (husband’s currently on mega-doses of ibuprofen — this view is not without some justification).
I feel like all doctors ought to distribute to their patients: “here’s a list of ‘things that will fuck with medication'” — because grapefruit juice is on that list. (okay, so some of the dry “here’s what not to do with the medication” sometimes says this.)
I didn’t know that. How many suicides were committed using Tylenol?
http://www.medicinenet.com/script/main/art.asp?articlekey=629
“I combined my interest in advocacy with this requirement…”
Dr. Saunders, forgive me for seeing a red flag. I do not doubt your character as a person, or intellectual honesty as much as any man has against his own biases.
Neither am I up on the medical specifics.
http://www.aaplog.org/position-and-papers/emergency-contraception/letter-to-the-fda-regarding-over-the-counter-status-for-plan-b/
I have no idea if any of the above is accurate; I trust you’re aware of these objections and have dismissed or minimalized them as clinically insignificant.
“Two studies examining emergency contraception (EC) have demonstrated that ready availability of emergency contraception does not produce a reduction in either abortion rates or unintended pregnancy rates.”
I don’t know what this means either, but it uses the magic word “studies.” That means science, scientific, all that authority.
I don’t know much about this atall. Let’s move the “11-yr-old” to mebbe 14 or 15 so emotions don’t cloud the issue. I’d say that’s the area of concern, old enough to do the nasty yet far short of adulthood.
I’m willing to explore the issue, with such a clinically qualified and manifest gentleman as yrself.
Best,
Tom
To your first point, all I can really do is shrug sheepishly and acknowledge the red flag. It’s quite reasonable to question the findings of an unpublished study that you can’t review, undertaken by an author who admits his opinions on the issue under investigation. (I decided not to put this on the main page because, while I felt it was worth bringing up, the bit where I discuss my study wouldn’t be forcibly convincing to those who aren’t inclined to take my word for things.) I can tell you in good faith that I got the results I got without manipulation, but I wouldn’t expect you to consider that particularly strong evidence in support of my argument.
Having read the letter in the link, there are a lot of responses. Their concern about the possible increase in ectopic pregnancy rates seems answered by this study. Their comments about emergency contraception causing abortions rely on a very conservative definition of pregnancy, and also on one (unlikely) mechanism of action for the medication. Their comments about patients who purchase Plan B without a prescription missing STI screening presume that those who would do so would overwise see a medical provider, which I dispute.
I concede that, statistically, easy access to EC does not seem to lower rates of unintended pregnancy or abortion. I would counter that this is any area that bears further study, and also that it is not a good reason to keep it out of the hands of adolescents who might individually benefit from it.
Finally, as far as 14- or 15-year-olds go — no, I’m no great fan of their having sex, either. That is a wholly irrelevant factor in whether or not they do have sex. I believe that those who do should have non-prescription access to EC, which I suspect is a belief you do not share.
xxx.lanl.gov. even if it’s not in a journal, why not let someone else see it?
Thx, Dr. Saunders. This is one of the few areas I have not become an expert in.
😉
My questions are [mostly, anyway] unloaded: I don’t know the side effects; it seems a rather harsh tonic. I’m cautious about the effects of misuse, which I’d expect to be sky-high with unsupervised adolescents. Taking it twice in one week? Five times in a month? Long-term effects of frequent use over a year or three? That sort of thing. As I said, it seems to be a harsh tonic.
Undoubtedly there are some minor risks to using EC (very very minor), but when contrasted with pregnancy, the ratio of risk goes to about zero. The rate of complication for pregnancy is around 1/3 (vaguely remembered number from nursing school), and in clinical trials plan B had a test of ~1300 doses, and the most significant side effect was heavy menses (30%) followed by stuff like delayed period, faster period, breast tenderness, dizziness etc.
These, of course, are insignificant side effects when compared to the risks of pregnancy.
EC is safe to take if you’re already pregnant, nursing or a pediatric. If you take it 5 times a month, nothing will happen. Remember, this is one of the same medicines used in birth control, which has been taken bazillions of times since the 60s, with the side effects coming mostly from the estrogens (clots, etc. as mentioned above).
The medication in Plan B is essentially the same as is found in many contraceptive pills. It is very safe, even is used repeatedly. It’s not meant to be used as a primary method of contraception (which is one of the legitimate problems that one could mention with making it OTC), but it’s really not much different than taking a progestin-only contraceptive pill. A woman who used it over and over might experience some unpleasant side effects (mainly vaginal bleeding, not to be graphic), but nothing especially dire.
I am disillusioned to learn that there are lacunae in your expertise, but will try to soldier on bravely.
You’re filling in my lacuna on this nicely, Doctor, and thank you.
Med question: What if she’s already pregnant and doesn’t know it?
I’ll continue to lean against this because I don’t acknowledge the rights of minors to be unsupervised. Neither am I certain that advocates such as yourself have yet fully sussed out the likely parameters of misuse, such as overfrequent use or the contraindications that would turn up had the girl been pre-screened.
And I don’t see how it can be clinically known at this time what the long term effects of misuse [abuse!] might be. I would think the data are sorely lacking on that.
But I do remain squishy in the area of early-term pregnancy as a whole, and so you’re helping me calibrate my outrage meter—so far, downward. There are many things worse in this world, and one must save his outrage for that which is truly outrageous. This seems to be falling below that threshold.
Cheers, mate, and again, thx.
My pleasure.
If she’s pregnant and doesn’t know it? She remains pregnant. The effects of Plan B on a gestating pregnancy are nil.
And an adolescent girl could take Plan B every day for years and suffer no particular ill effects, other than a higher likelihood of irregular vaginal bleeding. Again, Tom, the medication in Plan B is nothing more than progesterone, which is prescribed regularly in much higher doses as a non-emergency contraceptive. All forms of hormonal birth control contain it in some form, and we have decades worth of data about its safety and efficacy. Even if an adolescent were to use Plan B repeatedly (though that’s not how it’s supposed to be used), it would have no particularly worrisome side effects.
Thx much, Dr, Saunders, and you even answered my dosage question without me having to ask.
I shall research further on my own, but your answer appears to me to be that there is no negative effect on the reproductive health of the “patient.”
[Although I think you’ll stipulate that the data are lacking for the long-term effects of prolonged misuse.]
And on the moral level, that any moral objection must first hold the absolutist position that a “baby” is a baby from the moment of conception, and not at some later point thereafter.
You & I are miles apart on these things, but it’s gratifying to know—and to show other people—that it’s possible for two gentlepersons of good will to discuss such things, perhaps anything.
Short of who to vote for for president, of course.
;-P
That’s… not necessarily true. Even if what occurs at the moment of conception is not a baby, it might be something to which we have a moral obligation to protect. That’s a little off-topic, but the second is potentially more on-topic:
If the widespread availability of Plan B is not resulting in fewer unwanted pregnancies, then there are (off the top of my head, feel free to add more) at least three reasons for it:
(a) OTC or not, it’s not being used widely enough to have a statistical impace.
(b) It is being used in lieu of other contraceptives.
(c) The presumed safety of a Plan B alternative is resulting in more behavior that leads to unwanted pregnancies and the increase of this behavior is compensating for the protection that Plan B does provide.
In the event of “c”, and with a moral philosophy that holds that sex outside of relatively narrow contexts is morally wrong, then Plan B does represent a moral problem.
(I do not ascribe to this moral philosophy, and I think (a) is more likely true than (c), but it’s there.)
I’m glad to be having the conversation, Tom.
I will respectfully disagree with one of your stipulations. As I’ve said, the medication in Plan B is nothing more than low-dose progesterone. While it’s not the exact same one as in the progestin-only contraceptive pill (or “mini pill”), its side effect profile is about the same. Thus, we have reliable information on long-term use of medications very similar to Plan B that indicate long-term use (or misuse) may result in imperfect contraception or menstrual irregularity, but no significant adverse effects.
I will agree that, if you hold the belief that human life begins at the moment of conception, then one could argue that a possible mechanism of Plan B’s contraceptive effect (preventing implantation) is analogous to abortion. I do not hold that view, but if you do then I would understand a possible source of moral objection. I suspect you are right that we are rather too far apart on this particular subject to come to an agreement.
That said, I’m always glad to have your opinions. Hell, you can even tell me who you think I should vote for, though I can’t imagine you’d make much headway.
Stress is a strong influence on the odds of pregnancy (hence why “first time and pregnant” is relatively rare). This emergency contraception seems most useful for people who are otherwise unable/unwilling to risk getting on more conventional means of birth control — cases of incest, cases where they don’t want to tell a doctor/their parents that they’re sexually active on a relatively continual basis.
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.
An incredibly small number? Yeah. I can confidently say zero.
Sounds about right to me.
… because the people who won’t even sell condoms don’t exist? their happy little communities without birth control…?
I don’t think they vote Obama under any circumstances, mind.
I think this is close to the mark. If Sebelius had made a better decision, her decision might have rallied the conservative base even more against Mr. Obama. I think that’s also partially behind his decision to go after medical mairjuana distributors.
I still think this was dumb, dumb, dumb ( pace Will above). The social conservative base already hates Mr. Obama with the white-hot heat of a thousand suns. I have a very hard time believing that any of them are going to be more sympathetic to him in a meaningful way (ie. in eleven months) because of this, whereas his supporters who care about this issue are now needlessly angered (myself included).
I think that perhaps you’re right; however, it does deny Limbaugh, Hannity, et al., yet another opportunity to fan the flames and create a series of ready-made li(n)es with which the Republican candidates can rouse the base (the Obama administration wants your 11-year old daughter to have sex!!). I think the Obama administration is largely content for the moment with the prospect of Gingrich and Romney going at each other with fire and sword and is reluctant to distract the public with anything that might direct its anger at the White House instead. It might not change a statistically significant number of people’s minds about whether they’s vote for Obama, but given the current Republican enthusiasm gap with respect to their candidates, why motivate more of them to vote [i]against[/i] Obama, when they might just stay home? This particularly when the administration is trying to develop a narrative about how they are for the American middle class and not just the pointy-headed, effete, chardonnay-swilling East Coast elite types like me.
Nakedly political? Of course. Lily-livered? That too. But the 12th of Never? Assuming an Obama victory, I’d say more like February 2013.
doubtful. his base is conserva-dems. Still, I really see no reason why you couldn’t card a 14 yr old, and say — go talk to a doc, and get a note first, to the 9-13 set (this is NOT to say that they need a prescription each time, but that they ought to see a doctor For The Lecture Alone.)
Not sure the 14 yr old being raped by her step-father is going to go find a doctor – or knows how. Even with ‘consensual’ sex, ‘maturity’ in one adult area does not mean capability in others, like finding a doctor. I live in rural America, which has different problems than life in the big city.
Russell:
I agree that it is dumb but I guess they decided that it was better to do something that might anger their base rather than energize their opponents. That being said, even though you don’t like the decision you are still going to vote for Barry so in the end does the decision really matter?
Sure. Considering my choices on the GOP side, and the undeniable reality that neither of the candidates I would even begin to consider supporting (Huntsman and Johnson) have a snowball’s chance in hell of winning the nomination, I’m going to vote for Obama.
But perhaps, when approached by callers from the DNC asking for money, I’ll explain my disappointment, and why I don’t have the cash on hand to support a candidate whose agenda I find inconsistent on issues I care about. Or I’ll chose one of a number of options to soften my support.
Yes, cash in important but you will still vote for him and he will gladly piss folks like you off in an attempt to tip the balance with other voters. If you will always vote for him, are you really any different from those that will never vote for him?
Perhaps I’ve created the wrong impression. I won’t “always” vote for him. Were he, say, to try to revive support for the Federal Marriage Amendment, or invade Iran, or any number of deal-breaker decisions, I’d be unlikely to vote for him. (I’d either not vote, or pick some third-party candidate and cast a protest vote.) As pissed as this decision may make me, it’s not nearly a big enough issue to sway my vote in the direction of a GOP whose agenda I oppose almost without exception.
Well, Dr. Saunders, this may not be a deal breaker for you, but it sure is for me. It is a trivial decision that any smart 11 year old girl will be able to evade. But why go there? What is wrong with the Obama Administration is that they do not even try to do the right thing. I happily voted for him in 2008, but I have decided not to vote at all in 2012. If the inglorious Newt is what we get, it may be what we deserve. By the way, I am 65 years old and have never, heretofore, failed to vote in a national election. I am seriously annoyed.
Re: raw political calculation
Watching Colbert King (WaPo columnist) on Inside Washington this evening (the JV version of Washington Week), I think there’s as underestimated benefit in shoring up support in the African American community for Obama’s re-election, culturally conservative as it tends to be.
Card a 13 year old with what form of ID? Absent a passport, how is anyone under 16 going to prove her age?