A recent article in the NY Times about the FDA regulator responsible for oncology drugs, and his miraculous epiphany that maybe the glacial pace of approvals wasn’t such a good idea, has hardened my resolve that the FDA is, at best, a neutral organization, and at worst, which means always, is a destructive and retrograde force in health care in America. That Dr. Richard Pazdur’s wife was diagnosed with ovarian cancer, and that the good Doctor’s change of heart with respect to drug approval came at the same time is, of course, just a coincidence.
The proper function of the Food And Drug Administration (if there even is one) is to ensure that the studies done on these drugs were not falsified, and that the drugs themselves meet some minimum requirement for safety — that requirement being different for each class of drugs. By focusing on safety, and not efficacy, the FDA can let physicians do what they are trained to do: evaluate treatment options. Obviously, pimple medication should be held to a higher standard than chemotherapy for metastatic liver cancer or end-stage multiple sclerosis. All other decisions should be made by physicians and patients. That some ivory tower hack can control what my physician can prescribe for me is offensive. “Does it work?” is a question that is immensely difficult to answer, and one that is often not answered in the volumes of data that drug companies submit to the FDA. Yet the FDA got its paperwork, so the drugs are approved.
But Thalidomide! Yeah….I don’t care. Government physicians are by definition less interested in and probably less competent to make these decisions. If I choose the wrong doctor to treat my terminal jock itch and he prescribes the wrong medication, at least I have someone to blame…myself. But the lives that were not saved because of the iron boot of the FDA that rests squarely on the necks of drug researchers and their corporate masters are more important to me than some hypothetical threat to the lives of seriously ill Americans who can’t get drugs that may improve, prolong, or even save their lives because some bureaucrat had a bad day.