Saturday, December 10, 2011

Plan B still slightly out reach for women of child-bearing age.

On Wednesday, December 7, 2011, U.S. Health and Human Services Secretary Kathleen Sebelius overruled the U.S. Food and Drug Administration’s recommendation that women 16 and under can purchase Plan B, an emergency contraception, without a prescription. Sebelius explains in her statement that “In order for the contraception to be switched from prescription to over the counter, there must be “enough evidence to show that those who use this medicine can understand the label and use the product appropriately.” Sebelius believed that this standard was not met, and therefore, overruled the FDA’s recommendation for the prescription to over the counter switch.

At a press conference on December 08, 2011, President Obama was asked if he “personally intervened in any way in halting the sale of the "morning after" pill to those under 17, and whether you think politics trumps science in this case.” Obama made clear that he supports Sebelius’ decision and that the issue is about whether women 12-13 were capable of taking the medicine properly. If not taken properly the medicine can have adverse effects. Obama said that “[w]hen it comes to 12-year-olds or 13-year-olds, the question is can we have confidence that they would potentially use Plan B properly. And her judgment was that there was not enough evidence that this potentially could be used improperly in a way that had adverse health effects on those young people.”

Interestingly enough, the FDA maintains that it did take into account whether women 12-13 are capable of taking the medicine properly. Amy Nieman, the Vice President of Teva Women’s Health Inc, the company that submitted to the FDA the application for the drug to be made available over-the-counter said that “[p]art of FDA's consideration was a Teva-funded study that tracked 11- to 17-year-olds who came to clinics seeking emergency contraception. Nearly 90 percent of them used the pill safely and correctly without professional guidance.” But, as an Editorial in the L.A. Times points out, “Sebelius waited until the eleventh hour to make her decision, rather than asking the FDA for more data earlier in its deliberations.” With an eleventh hour move like that, one can’t help but ask if politics trumped science.

And science appears to be on the side of the FDA’s decision. In a recent statement, the Union of Concern Scientists expressed concern that Sebelius’ decision was a political move. “This is the first time a HHS secretary has overruled an FDA commissioner on a drug approval decision. Noting that Sebelius is not a scientists, the Director, Francisca Grifo, expressed concern that “The secretary’s decision undermines the ability of FDA to make drug approval decisions based on the best available science. The president’s support for the secretary’s decision is unfortunate, as it is inconsistent with his own March 2009 memorandum on scientific integrity.”

In the March 2009 statement Grifo refers to, Obama said science “must inform and guide decisions of my Administration on a wide range of issues, including improvement of public health.” And one would be hard pressed to argue with his statement that the public must be “able to trust the science and scientific process informing public policy decisions.” However, this is one of those situations where the administration lost the public’s trust.

In a piece entitled Obama’s Science Fictions, Michael Specter hints that this is just what has happened: the administration is losing the public’s trust. In the piece, Specter contrasts Obama’s previous statements pledging to bring science back to the center of the Executive Branch's decisions with his conscious choice not to do just that in this instance. He concludes by posing the question: “If you don’t accept the recommendations of your most able and well-trained scientists, if you reject research results that have been endorsed heavily by dispassionate experts, then where do you end up?”

Let me tell you where you end up: with a lot of upset people. The Vice President of the National Organization for Women, Erin Matson, expressed discontent, interpreting Obama’s statement supporting Sebleius as being overly paternalistic: “In saying that he thinks he knows what’s best for women … and then [he] goes on to trivialize emergency contraceptives.”

Andrea Grimes, a blogger who writes about “sex, gender and feminism in Texas,” delineated how she is disappointed and downright crushed by how the Obama Administration has handled making Plan B available to young women. She expresses her frustration with Sebleius’s decision to overrule the FDA’s decision and her anger with Obama supporting that decision – pledging to remove her Obama/Change sticker from her car.

Hether Corinna was filled with hope when the FDA finally got on board with making Plan B available to women 16 and younger w/out a prescription. This hope was lost with Sebelius’ decision and the Obama Administration’s support. Corinna is now encouraging young people and women to speak out and express their disconnect

What I find interesting is that Hilary Clinton has been a long-time activist of making Plan B available to women of childbearing age, but she remains silent on Sebelius’ decision and Obama’s support. Susan Wood, who was the top official of the FDA, lauded Clinton’s activism and her work with two other Senators in who were "champions for science driving FDA-decision making." Clinton played an active role in securing access of Plan B without a prescription for women. In 2005, Clinton stated that she believed Plan B should be made widely available to women. A Clinton spokesperson did not return a request for comment. I am curious to know if her trust in the Administration is equally as wounded as everyone else’s’.

1 comment:

S said...

Side note: Someone's translation of Obama's statement on Plan B.