Minor Thoughts from me to you

In American politics today, there is a simple question that divides us: who makes our choices? Do we make our own choices or do we stand aside and let someone else make our choices for us? This is the question that fuels the debate over school choice, over ethanol mandates, over FDA drug approvals, and over a host of other issues.

There are those that believe that only government employees can be trusted to make decisions. They believe that parents cannot be trusted to choose a school for their own children. They believe that drivers cannot be trusted to choose the best fuel for their vehicles. They believe that patients cannot be trusted to choose which medicines to take. As a result, they established the FDA to pick and choose our medicines for us. They established local School Boards to run the schools, making it as difficult as possible for parents to use non-government schools. They support ethanol mandates, to make us use the fuels they like best.

This governmental paternalism is always presented as a benevolent service. A service that government willingly provides to its citizens. But is it benevolent? Does government paternalism really make our lives better? Are we really better off if the government makes our choices for us?

Let me make this entire issue more personal: do you trust the FDA to make the right decisions about your drugs? Be cautious how you respond. The FDA has two criteria for approving drugs: is it safe and does it work? Every drug must be tested thoroughly -- a process that often lasts 10 years or more. Some drugs make it through these tests and are approved for sale, most don't.

What does it mean when a drug fails its tests? It means that the drug doesn't work more often than it does. It means that the drug hurts more people than it helps. It doesn't mean that the drug never works and it doesn't mean that the drug always causes harm. FDA employees look at the test results and make a decision. Does the drug work often enough, in a safe enough manner to be sold? In some manner, these decisions are arbitrary. There is no hard and fast line that can determine whether or not a drug is appropriate for human usage.

FDA doctors look at all of the variables, all of the tests, all of the evidence and make one decision. This decision is binding on all 300 million American citizens. This decision is no mere recommendation. It is a crime to use a drug that the FDA has not certified as being safe and effective. Both the patient taking it and the doctor prescribing it can be thrown into jail if their usage of the drug does not meet FDA "guidelines".

Is the FDA's decision really that valid? Is it really valid for all 300 million Americans? Probably not. There are tradeoffs involved in the decision to take any drug. Is it going to work? How well will it work? What side effects will there be? How severe will the side effects be? Is there a danger of death? How big is that danger of death? What benefits does the drug offer? How dramatic are those benefits? Are those benefits worth the danger of death? These are questions that don't have a one-size fits all answer. Some drugs may be very dangerous for some patients and very safe for others. Some drugs may have no effect on one person and a life-changing effect for another person. And yet, the FDA makes the same decision binding on both people.

Case in point: yesterday, the FDA heard testimony from patients with multiple sclerosis about a called Tysabri. This drug has been called a breakthrough for the treatment of M.S. Multiple sclerosis is a neurological disease that affects about 400,000 Americans. It wouldn't be surprising if a drug that treats neurological defects has neurological side effects. So it is with Tysabri. Tysabri has been linked to P.M.L. (progressive multifocal leukoencephalopathy), a rare but deadly neurologic virus.

On the one hand, we have a drug that's been hailed as a breakthrough treatment for a debilitating disease. On the other hand, we have a drug that can kill those who take it. Should it be available for patients to take or not? The FDA is currently deciding. The FDA is currently deciding whether or not M.S. patients can take a potentially life-changing (and possibly life threatening) drug. Why is the FDA deciding this issue? Why can't these patients make their own decisions? Pamela Clark of Salt Lake City told the agency that "We understand the risks of using experimental drugs, but we also understand the risks of doing nothing." She also reported that "Tysabri had allowed her to walk to a duck pond with her two 5-year-old sons and stand up long enough to cook dinner."

Tysabri has made Pamela's life better. It's allowed her to enjoy life again. She weighed the risk and decided that the benefit of the drug was worth the risk. Unfortunately for Pamela, she's not allowed to make that decision. She has to wait for the FDA to make the decision for her.

Do you think that's right? Do you think that Pamela should be prevented from deciding for herself? Do you think that her illness distorts her judgment in such a way that she is incapable of making her own decision? Would your answer change if you were in Pamela's shoes? Are you willing to turn control of your life over to government employees?

It's time to make a choice.