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Despite the legalistic title, this book is the third volume of a series considering the question, "What evidence should be used to accept or reject a drug as a therapeutic agent?" No one doubts that this is a philosophical question. Definitions of "safety" and "efficacy" are at best relative, and the evaluation of the critical ratio between them can be extraordinarily difficult. Recent advances in clinical methodology for evaluating drugs notwithstanding, problems about relevant and accurate measurement of clinical criteria, suitable experimental designs, and appropriate analyses of data still remain. So do others. Should toxicity in animal studies bar a drug from further clinical consideration? If not, how bad should the toxicity be? Is it desirable to find ways, perhaps through a "short-form research index," to bring drugs to limited clinical trials earlier? Lithium, levodopa, and methadone were cited as examples of drugs that were approved for clinical use with
Hollister LE. The Philosophy of Evidence. Arch Intern Med. 1974;134(4):789. doi:10.1001/archinte.1974.00320220191041