My colleague Susan F. Wood had an excellent op-ed in the Washington Post over the weekend about the Obama administration's overruling of the scientifically grounded FDA decision to approve emergency contraceptive Plan B for over-the-counter sale without age restrictions. She begins by going back in time to a much more promising moment: President Obama's signing of a Presidential Memorandum on scientific integrity:
It was a proud moment, in the East Room of the White House, on a beautiful spring day in March 2009. In the room were leading scientists, Nobel laureates, the president's science adviser and heads of organizations that had fought in support of scientific integrity in research and in government. I was excited to have been invited to watch President Obama sign a memorandum on scientific integrity.
The directive signaled that decisions about public health would no longer be blocked for reasons beyond scientific and medical evidence. Agencies such as the Food and Drug Administration would no longer have their decisions overturned by leadership that disregarded the science.
That promise was betrayed this past week when Health and Human Services Secretary Kathleen Sebelius overruled the FDA commissioner -- and all of the physicians and scientists at the FDA -- in blocking the agency's decision to allow an emergency contraceptive to be available over the counter for all who need it.
I resigned from the FDA in 2005 after serving for five years as assistant commissioner for women's health. I left because of my frustration that this safe and effective emergency contraceptive pill, Plan B, had been repeatedly blocked from going on sale over the counter. It was clear to me at the time that the recommendations of all the medical and scientific experts, both inside and outside the FDA, were being overruled by ideology, to the detriment of women and limiting their access to medicines.
Many of us thought the scientific integrity memorandum signaled the administration's willingness to restore science to its rightful place in addressing climate change, contraception, and other public health issues that have been contentious. In his remarks at the memorandum signing event, Obama even stated (emphasis added):
This Order is an important step in advancing the cause of science in America. But let's be clear: promoting science isn't just about providing resources - it is also about protecting free and open inquiry. It is about letting scientists like those here today do their jobs, free from manipulation or coercion, and listening to what they tell us, even when it's inconvenient - especially when it's inconvenient. It is about ensuring that scientific data is never distorted or concealed to serve a political agenda - and that we make scientific decisions based on facts, not ideology.
FDA scientists determined that Plan B is "safe and effective and should be approved for nonprescription use for all females of child-bearing potential" -- but the Obama administration did not listen. And while the decision to overrule the FDA's approval decision came from Department of Health and Human Services Secretary Kathleen Sebelius, President Obama made clear that he agrees with her decision, because he doesn't want to see 11-year-olds going into drugstores and being able to buy "a medication that potentially, if not used properly, could have an adverse effect."
As Susan Wood points out in her op-ed, the potential for adverse effects from improper use doesn't determine what we sell over the counter; if it did, acetaminophen (sold in brand-name form as Tylenol) wouldn't be available so freely. To compare Plan B and Tylenol, check out the National Library of Medicine's drug information on levonorgestrel and acetaminophen. Levonorgestrel's is fairly standard, but acetaminophen's begins with an IMPORTANT WARNING outlined in red:
Taking too much acetaminophen can cause liver damage, sometimes serious enough to require liver transplantation or cause death. You might accidentally take too much acetaminophen if you do not follow the directions on the prescription or package label carefully, or if you take more than one product that contains acetaminophen.
To be sure that you take acetaminophen safely, you should:
* not take more than one product that contains acetaminophen at a time. Read the labels of all the prescription and nonprescription medications you are taking to see if they contain acetaminophen. Be aware that abbreviations such as APAP, AC, Acetaminophn, Acetaminoph, Acetaminop, Acetamin, or Acetam. may be written on the label in place of the word acetaminophen. Ask your doctor or pharmacist if you don't know if a medication that you are taking contains acetaminophen.
* take acetaminophen exactly as directed on the prescription or package label. Do not take more acetaminophen or take it more often than directed, even if you still have fever or pain. Ask your doctor or pharmacist if you do not know how much medication to take or how often to take your medication. Call your doctor if you still have pain or fever after taking your medication as directed.
* be aware that you should not take more than 4000 mg of acetaminophen per day. If you need to take more than one product that contains acetaminophen, it may be difficult for you to calculate the total amount of acetaminophen you are taking. Ask your doctor or pharmacist to help you.
* tell your doctor if you have or have ever had liver disease.
* tell your doctor if you drink 3 or more alcoholic drinks every day. Talk to your doctor about the safe use of alcohol while you are taking acetaminophen.
* stop taking your medication and call your doctor right away if you think you have taken too much acetaminophen, even if you feel well.
Talk to your pharmacist or doctor if you have questions about the safe use of acetaminophen or acetaminophen-containing products.
As far as anyone can tell, this is the first time the Secretary of health has publicly overruled the FDA Commissioner. The Obama administration has not only failed to live up to the President's 2009 commitment to listen to scientists even when it's inconvenient to do so; it has also set a dangerous precedent for future administrations to trump science with politics.
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Not quite, although the considerations I will discuss may not be the FDA's job to do. Deciding what people can do, especially minors (I hate that term but it has legal ramifications) is not just "science", it's about social and legal issues. Pure "science" would just be, things like judging the relative cost-benefits of effects versus side effects etc. But whether young people can buy X, includes a judgment call about how that affects the society, whether their parents want them to be able to do that, our traditions of presumptive mature judgment etc. The issue is a bit like, how to decide to end life etc - what do we use to judge by? It just can't be compared to pure medical science, that's that - right or wrong or unknown or unknowable as the decision itself may be.
I have my own pet peeves, like allowing medical marijuana (or just allowing it) but there is a judgment call about what "we" will consider an acceptable effect on people and society - a value judgment of the effects. These things are just not pure facts.
FWIW, I have dealt with the FDA various times as part of medical manufacturing, and food/bev./cosmetic/medical import/export/registration.
I see what you're saying, Neil, and it's true there are issues that require more than science to address. In this case, though, FDA's job was to examine scientific evidence to make a determination about the safety and efficacy of making a drug more readily available to a larger population (e.g., can 11-16-year-old girls understand the drug instructions and take the drug as directed). FDA did that job.
Sebelius claims that she's overruling FDA based on the scientific evidence, but her justification on those grounds is weak, and the most plausible explanation is avoidance (possibly at Obama's behest) of the political consequences of having Plan B available over the counter.
OTC sale of pseudoephedrine is actually a great example of a drug-regulation approach that accounts for the drug's broader effect on society. FDA was satisfied that pseudoephedrine-containing drugs are safe and effective enough to be sold over the counter, and for many years they were. However, after it became clear that such drugs were being used in the production of methamphetamine, Congress passed a law restricting how such drugs could be purchased (from a pharmacist, presenting identification, and only in limited quantities).
In the case of pseudoephedrine, there is a clear distinction between 1) the science-based decision about the drug's safety for individuals taking it and 2) Congressional action based on its larger impacts on society.
"there is a judgment call about what "we" will consider an acceptable effect on people and society - a value judgment of the effects"
Except you're not told about the effects.
Which, if bad, are only bad for some business interests.
The effects of marijuana is minimal, even nonexistent compared to accepted drugs like tobacco and alcohol.
But you're not allowed to know those effects. Any report that says so is ignored.