Plan B One Step (762 x 476)

By now, you probably have heard that HHS Secretary Kathleen Sebelius instructed FDA Commissioner Margaret Hamburg not to approve the application to make Plan B One-Step, a single pill emergency contraceptive, available to all women. (Hamburg wasn’t happy.)

Right now, Plan B is available OTC only to women who are at least 17 years old. In a terrific commentary in the January 12, 2012 issue of the New England Journal of Medicine titled “The Politics of Emergency Contraception,” Alastair J.J. Wood, MD, Jeffrey M. Drazen, MD, and Michael F. Greene MD deride the decision, saying it is “once again…a situation in which political considerations are forming the basis of public health policy – resulting in another sad day for women.”

 

Here is what they say about the product:

  • Plan B One-Step consists of a single 1.5 mg tablet of levonorgestrel, a progestin.  It prevents pregnancy mainly by delaying or preventing ovulation, but, “prevention of implantation cannot be ruled out.”  It does not cause abortion – the termination of an established pregnancy.
  • It has a long and well-studied history of being safe, regardless of whether it was obtained with or without a prescription.
  • It works best if taken as soon as possible after an episode of unprotected intercourse.  Inserting the need to get a prescription will add a significant delay before the drug can be taken. Further, the process of showing your ID to prove you are old enough to get it is humiliating and may discourage access, particularly in tightly knit communities where the young woman’s neighbors or peers could be behind the counter

Despite this, Sibelius stated in her missive to Commissioner Hamburg, that “based on [her] review, [she] has concluded that the data submitted for this product do not establish that prescription dispensing requirements should be eliminated for all ages.”  Why? This drug is safe, pretty effective, and easy to use. In fact, 15 and 16-year-olds can purchase much more dangerous drugs OTC anytime they want – think acetaminophen or aspirin.

 

According to the authors, it is pure politics.

“Any objective review makes it clear that Plan B is more dangerous to politicians than to adolescent girls.” This was a pure political play designed to appeal to social conservatives.  But why?  I say it is time for the Dems to wake up and realize that this constituency is not going to vote for Obama et al regardless of whether the administration sells out women and girls. Hey, guys, haven’t you figured out that you are not, pun intended, their Cup O’ Tea.

Kudos to the authors for a writing such a strong statement (no shrinking violets, this crew) and to the NEJM for publishing it (I guess it helps that two of the authors are Editors of the Journal.)  We need more people and more journals (and more bloggers, tweeters, etc) to keep on outing offenders who try to disguise politics as science.

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