In recent years, the wisdom of investing the FDA with so much power has been called into question. AIDS patients, unable to get access to experimental drugs, have invaded the FDA’s Washington headquarters in protest. Alzheimer’s disease patients, unable to obtain the drug THA, have filed a class action suit. Breast cancer patients have formed an anti-FDA lobbying group, and even the National Cancer Institute has complained about FDA tardiness in approving new drugs.

Such complaints are not new. In the professional literature in the 1970s, the FDA was accused of responsibility for 10,000 heart-related deaths a year because it kept beta-blockers off the U.S. market long after they had proved successful in Europe. The current policy of denying people on death’s doorstop an opportunity to take risks would seem unwarranted and in need of change.