A Funny Thing Happened on Plan B One Step’s Way to the Drugstore Shelves…

Headline Washington, Thursday 8 December 2011- President Obama, who took office pledging to put science ahead of politics, averted a skirmish with conservatives in the nation’s culture wars on Thursday by endorsing his health secretary’s decision to block over-the-counter sales of an after-sex contraceptive pill to girls under age 17. www.truth-out.org

No doubt you’ve heard of the Obama Administration’s move to override the FDA’s decision to allow the “morning after pill” to be sold over the counter. It surprised the heck out of Teva Women’s Health, Inc., makers of Plan B One Step, when they heard their preparations to take the drug OTC were for nothing. One word came to mind when I heard about the decision: politics. Supporters of the decision say it’s a good idea because a pharmacist can still sell it to anyone who can prove they are at least 17 years old. Like many others who are uncomfortable with the idea of lifting the age restrictions on the sale of this product, Obama balked at the idea of a 10 or 11 year old being able to buy it “alongside bubblegum or batteries”. But there’s an election year coming up; my guess is that the president is ducking a 100% guaranteed confrontation by making sure One Step remains right where it is – behind the counter.

The FDA’s recommendation that the emergency contraceptive be available over the counter without age restriction was based on their research that said the pill was safe and effective for nonprescription use and that adolescents could use it properly without the intervention of a healthcare provider. Then the secretary of Health and Human Services (HHS), Kathleen Sebelius, stepped in. According to the British newspaper, The Guardian, Sebelius “was concerned that the manufacturer had not studied whether 11-year-olds, some of whom are capable of bearing children, would fully comprehend the product’s label and appropriate use.” Obama was very careful with his response; he voiced support for the Sebelius move while distancing himself from it. “As the father of two young daughters, I think it’s important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine,” he said. He also made it a point to say that he was not involved in the decision; he had left it up to Sebelius.

When it came to issues like stem cells, climate change, sex education and contraceptives, Bush’s administration watered down or outright suppressed the findings of government scientific agencies. So naturally the scientific community rejoiced when Obama vowed to “restore science to its rightful place” in his 2008 inaugural address. He has also said that he would ensure “that scientific data is never distorted or concealed to serve a political agenda.” But the evidence that Plan B is safe, effective and easy to use suggests that the Sebelius decision was not determined by science at all. Plan B works by suppressing ovulation and is 89% effective in preventing pregnancy if taken within 72 hours of unprotected sex. It has no serious side effects and will not terminate a pregnancy that has already begun. Plan B, therefore, is a contraceptive, not an instant abortion pill, as some anti-choice groups would have us believe. Quite the contrary. Research by the University of Chicago shows that since 2006, when emergency contraception was made widely available, it “lowered the risk of unintended pregnancy…and played a significant role in the decline of abortion between 2005 and 2007.” Moreover, a 2009 study in the journal Obstetrics and Gynecology showed that women and girls as young as 12 have consistently demonstrated a good understanding of how the drug is used and when they should use it. Sounds like good scientific evidence to me, but despite the findings of these and other studies, Sebelius nixed greater accessibility to the drug and cited “scientific uncertainty” to justify her action.

I suppose we could argue all day about how certain “scientific certainty” is, anyway. But the fact is that the FDA routinely approves drugs before every bit of research that could be done on them has been done. Many medications on the market have not been assessed for safety and efficacy for use in children, for example, or for women or people over 65. The difference is that with Plan B we’re talking about sexually active 11 year-old girls who are capable of becoming pregnant. There’s an “ick” factor here – discomfort with the idea of adolescents having sex lives and becoming parents. The Washington Post reported that Obama aides admitted that the decision wasn’t about science, but about a “gut feeling that teenagers might not be ready to make decisions about pregnancy.” Guess what, Mr. President, the minute adolescents choose to have sex they are making a decision about pregnancy – no matter how ill-informed or unconscious that decision may be. And speaking of ideas that are of questionable scientific merit – many Americans still believe that providing access to sex education and contraception will give kids the idea sex at any age is OK, so we have curtailed access. My grandson, for instance, just completed a sex ed module in his 7th grade health class. A permission slip was sent home for me to sign, outlining the content of the lessons. The subject of birth control was not mentioned. Parents had objected, apparently – too many kids having sex too early. The American Public Health Association reports that 33% of teens have had sex by 9th grade. That’s age 14, folks. Something tells me that refusing to educate kids about birth control isn’t working.When Obama and Sebelius refused to put themselves on the record by saying that making Plan B available OTC to adolescents made sense, they were simply refusing to grab hold of the teenage sex/contraception/abortion hot potato. Taking a stand means risking controversy, criticism and votes. So as politicians are wont to do, they took the easy way out and rejected the science on Plan B based on claims of “scientific uncertainty”. Slick.

The FDA decision promised to poke a great, big hole in America’s provincial attitude about sex but for now, anyway, Plan B One Step will remain off drugstore shelves. That’s unfortunate because wider access to the drug would be a safe, effective way to reduce the teenage pregnancy rate. And that rate, despite our collective head-burying, is on the rise. As long as the Obama administration continues to make women’s health decisions based on politics, we will continue to maintain the status quo. Looks like religion, emotion and kneejerk reactions trump science once again.

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One thought on “A Funny Thing Happened on Plan B One Step’s Way to the Drugstore Shelves…

  1. I read this blog post right after I read your post on Yaz fudging studies, and convincing the FDA to leave it on the shelves. It puts Obama’s decision to keep it behind the counter in a different light.

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