Cecil L. Wittson

Hazards of drug evaluation: trials of 84 non-approved drugs.

1. If sufficient medical care is provided, compounds on which adequate animal toxicity studies have been done, do not appear to involve hazards in clinical trials. This conclusion is based on 93 drugs evaluated over a 4-year period in 1,704 patients; 84 of these drugs had not been approved by the Food and Drug Administration. 2. Other factors which tend to delay drug evaluation efforts include: the isolation of the chronically mentally ill from medical research centers, the lack of status associated with this type of research, the peculiarities of psychiatric practice and the source of the new compounds available for evaluation.

DRUG EVALUATION AND BASIC RESEARCH UNITS IN STATE HOSPITALS

To the Editor:— The number of new drugs being introduced for the treatment of the mentally ill, the lack of a standardized system of reporting treatment results, and the conflicting reports as to the effectiveness and indications for the various preparations require that a state establish its own continuing drug evaluation program. In order that such a system of evaluation may function efficiently, personnel must be trained to evaluate behavioral change, this evaluation should be based on direct observation that may be communicated, patients must be categorized to allow for the comparison of comparable groups, and a pattern of procedure must be established to avoid delay in implementing the testing of new products. In addition to the immediate need for the determination of the effectiveness of a recommended therapy, a basic research program must be encouraged by providing specialized personnel and the necessary laboratory facilities for the psychiatrist and those