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We at the Bureau of Drugs would like to comment on Dr Spence's suggestion for dealing with the laetrile problem. We have recently seen several similar proposals to legalize the drug. Some, as Dr Spence, would have it made an over-the-counter product to keep it out of the domain of charlatans; others would make it a prescription drug that could be offered together with effective methods of treatment. The idea that the laetrile problem can be disposed of by making the drug freely available is like the notion that corruption can be eliminated by legalizing graft. We cannot accept it.Neither laetrile nor any other drug may be placed on the market in this country unless there is evidence from well-designed, well-controlled studies showing that it is safe and effective. The evidence standard is a good one. The United States led the way in adopting it as the
Levanthal CM, Crout JR. Comments on Laetrile-Reply. Arch Intern Med. 1977;137(7):964-965. doi:10.1001/archinte.1977.03630190104032