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Opening Arguments

Right to try

Michigan now has a "right to try" law for terminal patients:

The act allows those suffering from advanced illnesses to receive experimental treatments outside of FDA-approval, if all approved procedures have failed to help the patient. The treatments would only be allowed under a doctor’s supervision. Under the law, medical professionals and health care facilities are protected from liability if the experimental treatment does not have a positive result for the patient.

This is so common-sensical you wonder why a law is needed, and if one is why it isn't a U.S. law instead of the states having to do it themselves (Michigan is the fourth state this year to enact one). The sick people get one more shot at life (desperate though it may be), and the rest of us might learn something that will help us down the road. Remoember those poor cancer-ridden people who had to go to Mexico for those peach-pit treatments?

Here's economist Walter Williams on why the FDA is so pigheadedly reluctant to authorize new drugs and treatments:

The Food and Drug Administration can make two types of errors. It can approve a drug that has dangerous unanticipated side effects, or it can reject or delay approval of a drug that is safe and effective. Let's look at these errors, because to err on the side of under- or over-caution is costly.

It's in an FDA official's self-interest to err on the side of over-caution. People who are injured by incorrectly approved drugs — and their families — will know that they are victims of FDA mistakes, or under-caution. Their suffering makes headlines. FDA officials face unfavorable publicity, perhaps congressional hearings and possible termination.

The story is very different when the FDA incorrectly delays or denies drug approval — errs on the side of over-caution. Here victims are people who are prevented access to drugs that could have helped them. Their suffering or death is seen as reflecting the state of medicine rather than the status of an FDA drug application. Their doctor simply tells them there's nothing more that can be done to help them. This kind of FDA victim is invisible.