Monday, December 12, 2011

Department of Health and Human Services Shows It is Driven by Politics, Not Science; Sibelius Overrules FDA and Bans Over-the-Counter Plan B Access

In an unprecedented move, the Secretary of Health and Human Services - Kathleen Sibelius - overruled an FDA decision that would have removed the age restriction on over-the-counter sales of the morning after pill (also called plan B or emergency contraception), allowing access to the pill for girls below age 17 (the lower limit for sale would have been age 11).

It is thought that this is the first time that the Secretary of Health and Human Services has overruled an FDA action.

There is strong evidence that the morning after pill is safe and effective for girls between the ages of 11-16. Research has shown specifically that 11-16 year-old girls are able to read and understand the directions, use the product safely and effectively, and do both of these without physician consultation. The only significant side effect is nausea, which lasts a few hours (nausea associated with pregnancy can last months). There is no risk of overdose. Moreover, there is strong evidence that availability of the medication does not lead to increased unprotected sex among adolescents or young girls.

In other words, as the American Council on Science and Health emphasized in its Facts and Fears column last Thursday, there is no medical or scientific reason to overrule the FDA's decision.

What was Secretary Sebelius' reason for overturning the FDA's decision? According to several newspaper articles, the Secretary argued that young girls are unable to "understand the instructions." Sebelius noted that: "there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age."

The Rest of the Story

Secretary Sibelius argued that the cognitive differences between older and younger adolescent girls renders the younger girls incapable of understanding and following the instructions for the use of the morning after pill.

Let's examine, then, the instructions to see how hard it might be for an 11- or 12-year-old girl to follow them.

The instructions are as follows: "Take one white pill."

Now I can see where Dr. Sibelius is coming from. The instructions entail taking one pill. That seems far too difficult for an 11-year old to comprehend. Clearly, the girl would need to consult with her physician to understand what she is supposed to do.

For one thing, she may not understand the number one. Her doctor can review her numbers with her and explain what is meant by the number one.

For a second thing, she may not know her colors. The physician can explain to her what "white" means by giving examples of things that are white.

It's hard to fathom how an 11-year-old would be able to comprehend instructions as complicated as "take one white pill."

President Obama supported the Secretary's decision, arguing that the younger girls may not be able to use the pill properly.

I see the President's point here. A 14-year-old might mistakenly think that the pill is designed to be placed into the ear, rather than swallowed. Or she might think that, like snus, the pill is supposed to be placed in the nasal cavity. There are innumerable ways in which girls could use the pill improperly.

Clearly, the arguments being put forward by both Secretary Sibelius and President Obama are a smokescreen. They make no sense. It is quite evident that the real reason for their opposition to the pill are political. They are afraid that the decision to make the pill available could be used against the President in the 2012 presidential election campaign, especially since his opponent is certainly going to be a strong conservative candidate.

This is an egregious example of politics, rather than science, guiding federal public health policy. It is also the reason why I am not optimistic about the federal government - including the current administration - taking any major action that would actually put a dent in cigarette sales. When it comes down to it, politics will outweigh science and we're not going to see any major policy action that would substantially reduce the government's cigarette tax revenues. This is just one reason why I don't think a menthol cigarette ban will see the light of day, and certainly not before the 2012 election.

The rest of the story is that despite the promises when President Obama took office, politics - and not science - is still dictating federal public health policy. This is hardly what I imagine President Obama had in mind when in his inaugural address he called for "science to be restored to its rightful place."

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