Science Has the Answer -- Depending on the Question

In making her decision on Plan B, Kathleen Sebelius did not say that the FDA's science was wrong or that she had her own experts who disagreed with the FDA. She was making a policy decision, not a scientific decision.
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Science and politics have an uneasy relationship in the U.S. In part this stems from a lack of recognition of what questions science can answer and what questions it can't. The result can be legitimate disagreements on policy in situations where the policy questions are related to but are not scientific questions.

To bring out the issues, two medical examples will be discussed. Scientists like to use gedakens, thought experiments, to understand problems. In trying to understand the effect of temperature on a physical phenomenon, we will frequently ask what happens if the temperature goes to infinity and what happens if the temperature goes to absolute zero. Such black and white temperatures are useful to look at possibilities even though they are not physically realizable. Here I may make the scenarios black and white to clarify issues in the same vain as taking the temperature to infinity and absolute zero in a physic's gedanken.

Consider the situation of a new drug for women diagnosed with advanced stage breast cancer. The drug looks very promising in initial clinical trials. Because the need is urgent, the FDA fast tracks the approval, and the drug begins to be widely used. After several years of wide use, very detailed large scale clinical studies show first that the drug has absolutely no efficacy, and second that it has serious side effects that actually shorten the average patients life and degrade the quality of life, completely opposite of the intent of the drug. The FDA pulls the drug from the market.

The FDA's decision is strictly scientific. Why? Everyone agrees that advanced breast cancer is bad. Everyone (well almost everyone) agrees that a drug that can help with advanced breast cancer is good. Then the question is, does the drug help with advanced breast cancer? This is a scientific question. As described above, the evidence is indisputable. The FDA's decision is not controversial. The drug manufacturer may be unhappy because of the financial implications, but who wants to give a patient a drug that makes her worse off with no benefits?

Now let's consider another drug, Plan B. Again, I am going to assume for this discussion that the scientific evidence is incontrovertible. The drug is effective. It has little or no side effects. Even young girls (hypothetical eleven year olds) are capable of reading and understanding the directions, and using the drug as directed. Let's even go further and say that scientific studies show that the availability of Plan B does not increase sexual activity among girls, and it does reduce the number of abortions that are performed each year. The FDA approves the drug for over the counter sale, which means even young girls can buy it without involvement of adults. Nonetheless, the Secretary of Health and Human Services, Kathleen Sebelius, overrules the FDA and President Obama supports her decision. There is a loud outcry that the President has gone back on his promise that his administration would not overrule scientific decisions.

However, Plan B is fundamentally different from the breast cancer drug discussed above. While everyone agrees that a drug that helps with advanced breast cancer should be provided to patients, the same is not true of Plan B. There is large segment of the population that will acknowledge that the drug is effective, but they do not believe that children should be allowed to make the decision of whether to take the drug without adult involvement. Such considerations depend on personal beliefs involving the structure of the family and the role of parents in children's lives. There are philosophical, moral, and religious arguments on both sides of the question as to whether Plan B should be provided to girls without adult involvement. But philosophical, moral, and religious questions are not scientific questions. Science can address whether the drug is safe and effective. But the fact that the drug is safe and effective does not answer the question as to whether it should be offered as an over the counter drug. In making her decision, Sebelius did not say that the FDA's science was wrong or that she had her own experts who disagreed with the FDA. She was making a policy decision, not a scientific decision. We may disagree with her decision or agree with her decision, but it was not a decision in which science has the answer.

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