Laetrile: the regulatory challenge of an unproven remedy.

The controversy over Laetrile is nearly at an end, the worthlessness of the drug having been demonstrated beyond reasonable doubt. But the Laetrile experience raised important questions of public policy, some of which remain unresolved and all of which are worthy of examination. Could the Laetrile phenomenon have been prevented? Did the regulatory system perform as intended? Could there be another Laetrile? The drug regulatory system administered under law by the Food and Drug Administration, like any other system carried out by Government in a free society, functions only so long and so far as the public will allow. Survey after survey shows that there is overwhelming support by the American people for the consumer health protection activities of the FDA. But, as the case of Laetrile proves, that support is neither absolute nor permanent. It can be selectively or totally withdrawn. In those circumstances, it would seem that the best, perhaps the only, recourse in a free society is for those institutions and groups that have a responsibility for protection of the public health--institutions outside Government as well as within it--to identify, expose, and halt quackery that threatens the public health and welfare. Their weapons in such a struggle are facts as well as laws, credibility as well as confidence, compassion as well as the scientific method. While the role of a drug regulatory agency may be limited, submission of scientific data as part of application for an investigational permit should be encouraged. If a promoter of an unproven remedy does not follow the usual channels to demonstrate safety and efficacy, consideration must be given by others to sponsoring such studies; however, concurrent regulatory (enforcement)and public education activities are to be encouraged and should not be seen as conflicting.