“Dr.” Sebelius’s Bitter Pill: A Case of National Malpractice


See all our coverage of the Administration’s 2011 Emergency Contraception Reversal here.

This week Doctor Kathleen Sebelius prescribed us a bitter pill…

But wait, she’s not a doctor, but rather a political bureaucrat, former politician, former lobbyist for the Kansas Trial Lawyers. This week she only played a doctor, and in so doing she ended up committing national malpractice.

Despite the overwhelming recommendation of medical experts, including the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American Medical Association, as well as her own Federal Drug Administration (FDA) Commissioner, Not-a-doctor Sebelius decided to substitute her own medical judgment and continue to limit the accessibility of the Emergency Contraceptive Plan B One-Step.

On the same day that FDA Commissioner Hamburg confirmed that Plan B One-Step had been carefully evaluated for more than a decade and as a result deemed safe and effective for its intended use based on scientific evidence, Secretary Sebelius formally kicked off the 2012 election by siding with the political professionals over the medical professionals.

Even though the Administration’s own FDA Commissioner along with a group of experts from the Center for Drug Evaluation and Research, which included obstetricians, gynecologists and pediatricians “reviewed the totality of the data and agreed…that Plan B One-Step should be approved” for non-prescription, over-the-counter access, Secretary Sebelius thought otherwise.

She ignored the experts, a decision that will have far reaching public health ramifications, not least of which is undermining the FDA decision-making process itself.

And remember, this comes from an Administration that vocally and quite often accused the previous administration of elevating politics over science.

Just newly elected, in March of 2009, the Obama Administration declared: “…in this new administration, we base our public policies on the soundest science…(not) politics or ideology…”

Unfortunately, this week’s decision on whether to grant over-the-counter access to Plan B One-Step confirms that President Obama’s declaration of science first may in fact be nothing but politics.

And today the Obama Administration looks a lot more like the Bush Administration it used to so openly mock for its prioritization of politics over science. And there have to be those in the Administration wondering how politically astute it is to have become Bush Lite on vital national health considerations.

But let’s not allow Secretary Sebelius’ bad advice to the President to diminish just how profound a change this would have been for America’s women.

It would have been the first new contraceptive readily available on store shelves in more than a generation. It would have been a groundbreaking step in normalizing contraception. It would have provided women greater access to safe and reliable contraception, an essential part of basic health care.

On-the-shelf access emergency contraception just makes sense, because things don’t always work out as planned. All women need timely access to a safe, effective backup method of contraception if they (or their partner) failed to use a method, or if their chosen method failed them. And for those concerned about providing emergency contraception to teenagers, the National Campaign to Prevent Unintended Pregnancy has confirmed that there is “no evidence to suggest making contraception, including emergency contraception, available to teens encourages them to begin having sex, to have sex at younger ages, or to have more sexual partners”.

Most of the nation’s medical professionals agree that Plan B One-Step should be available without prescription, just not Doctor Sebelius.

And so when presented an opportunity to take a significant step forward for women and correct the rightwing, ideologically driven decision of the Bush Administration, the Administration has taken two huge steps backward.

They took the bait that the best way to protect teens was to limit access to contraception instead of recognizing that when teens do become sexually active, the best way to protect them is to ensure they have access to safe, effective birth control, including backup methods.

Is this change we can believe in?

It’s certainly not a “common sense” solution.

And now we can only ask that President Obama do what Secretary Sebelius should have done in the first place, listen to the real doctors and the FDA Commissioner, and have this decision driven by science, public health and clinical expertise, not politics.

Because this is a bitter pill no American woman should have to take.

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Reproductive Health Technologies Project advances the ability of every woman of any age to achieve full reproductive freedom with access to the safest, most effective, appropriate and acceptable technologies for ensuring her own health and controlling her fertility.  

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  • prochoicegrandma

    Fabulous article, Kirsten Moore!  

     

    I feel it is important to keep pointing out the lame excuse that Kathleen Sebelius used to overrule the FDA, that young girls might not “understand the label and use the product appropriately”. Here is the Plan B label instruction:   

    “Take the first tablet as soon as possible within 72 hours of unprotected sex. The sooner you take the first tablet, the more effective Plan B will be. Take the second tablet 12 hours later.”

    http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021045s011lbl.pdf

     

    ETA:  If a girl age 11-16 is unable to understand these simple directions, then she certainly would not be able to understand “What To Expect When You’re Expecting”!

  • sschoice

    Back about ten years ago, around the time EC was first made available OTC through PREVEN and Plan B, there was a lot of attention given to certification and training programs to both help pharmacists act as a bridge between OTC access to EC and related care that women, especially teens, would need.  But we haven’t heard much about certification in recent years. 

    Did these certification programs that — to us anyway — seemed to give significant attention to n educating pharmacists on how to talk with customers about EC and act as a bridge to other providers just disappear when Plan B went OTC, or did they maybe become something like a CME (continuing medical education) program, more about teaching simple facts about forms of EC, like a pharmacist might get from a PDR or package insert?

    We’re asking because it’s not clear if these programs still exist or if they are growing or what, from websites we’ve looked through like the American Pharmacist Association (APhA).   These programs existed  in nine states back in 2006 allowed some pharamcists, at least, to dispense EC OTC to minors, as mentioned in this 2006 statement from the APhA:

    APhA Statement on FDA’s Recent Approval of Plan B for OTC Status

    August 24, 2006

    http://www.pharmacist.com/AM/Template.cfm?Section=News_Releases2&template=/CM/ContentDisplay.cfm&ContentID=6569

    If we read the press releases and policy statements of other groups like American Public Health Association (a differnet group with the same acronym as the pharmacist group mentioned above), similar support and concern is expressed about minor’s access, but while it is consistently mentioned it is not much emphasized — like in the following article, for example, try searching for the few occurances of the word “age”:

    Ensuring that Individuals are Able to Obtain Contraceptives at Pharmacies

    Policy Date: 11/8/2006

    http://www.apha.org/advocacy/policy/policysearch/default.htm?id=1335

    What is the status of certification programs that help create collaborative agreements with pharmacists who want to dispense EC OTC to minors? 

    If they still exist, are they growing?

    Would they be something that activists could help support to improve OTC access for minors?

  • kirsten-moore

    Thanks for the feedback. As it happens, the product now on the market and the one that would have gone on the shelf has just one pill. The directions basically say ‘take this pill now’. That’s it.

  • sschoice

    I’d have to do some research to say exactly why collaborative agreements were proposed in the first place between pharmacists and doctors to allow OTC dispensing of EC, but I think it was to ensure that pharmacists asked a structured list of questions that noted the last menstrual period of the woman using EC to ensure she wasn’t using EC if she was already pregnant, and ensure the woman using EC would use a pregnancy test after using EC to make sure it was effective, and to detect pregnancy as early as possible if it occured in spite of taking EC.  I don’t think pharmacists participating in these agreements had to refer women to one particular medical provider for questions, but it may have made it much easier to give information and referral to providers for care beyond the woman simply getting EC.

    Collaborative agreements began as an experiment and I think pharmacy boards in different states implemented them differently.  But they were meant to help improve access for all women, including explictly for minors, as the APhA statement said:

    APhA Statement on FDA’s Recent Approval of Plan B for OTC Status

    August 24, 2006

    http://www.pharmacist.com/AM/Template.cfm?Section=News_Releases2&template=/CM/ContentDisplay.cfm&ContentID=6569

    “In nine states, pharmacists have explicit authority to work with doctors to both prescribe and dispense emergency contraception, so that a patient does not need to visit their physician. When this novel over-the-counter and prescription approach is implemented later this year, women under the age of 18 may go directly to trained pharmacists in those states and, when medically appropriate, receive Plan B directly from the pharmacist. “

    I’m sure I could research this further by calling state pharmacy boards, but does anyone have suggestions for articles or reports on how these programs are doing?  I’ve tried some searches of the APhA website and some related professional organizations and I haven’t found any reports from the last few years, nor any reports of the programs downsizing or disappearing.  I wonder if there may be less interest in them due to Plan B being made available first to women 18 and older, and then 17 and older through that court ruling a couple years ago.  If there is less interest, that’s unfortunate, and it would be seem to be a good idea to encourage participation in these programs.