Source: Wall Street Journal (free link).
The writer blames bureaucratic error for the failure he describes, but I suspect the cause is more fundamental.
The story tells of an effective and desirable pain-relief medication that became unusable in practice. I think the root cause of this unfortunate outcome is the misuse of government to perform tasks for which it is not well suited.
It may seem that public safety is a legitimate function of government. Indeed, we explicitly endorse this assumption with respect to law enforcement and police operations. But somehow public safety was not served in the case of ketorolac. People even died.
The reason is that public safety is not a valid model to apply to the practice of medicine. Whereas a police officer can ensure public safety by removing harms, removing harms from the practice of medicine actually stops innovation and improvement.
Consider the problem of testing a new drug. To show that it is safe and effective you must give it to some patients while at the same time not giving it to other patients. If the drug “works” and even if it doesn’t, one or the other of the patient groups will be harmed (at least comparatively) by their participation in the trial.
This is an irreducible reality that no medical policeman can overcome. In effect, the criminal cannot be removed from the scene for the benefit of the residents.
The solution is to accept that government inherently cannot police medicine. It can police bad actors in medicine in all the usual ways, but government is not capable of eliminating harms from the practice of medicine.
One thought on “How the FDA Helped Fuel the Opioid Epidemic”
The FDA serves no useful purpose whatsoever regarding medications.
Efficacy can best be judged by physician’s medical journals and safety assured by the product liability insurers.