A review of patient outcomes in pharmacological studies from the psychiatric literature, 1966–1993 [Book Review]

Science and Engineering Ethics 3 (4):395-406 (1997)
Abstract
 A literature search was conducted on studies of new drugs used with patients with schizophrenia reported by U.S. and non-U.S. researchers from 1966–1993, yielding 41 U.S., and a total of 24 other non-U.S. studies, among them 11 British studies. Results of the U.S. and non-U.S. studies were pooled separately and compared. Among several comparable conditions discussed, the lack of any data on suicides in the U.S. studies was observed. For a second statistical analysis of suicide rates ‘person-years’ were calculated to adjust for differing washout durations. The results obtained include findings that the percentage of patients relapsing in U.S. studies was slightly lower (37.9%) than in non-U.S. studies (46%); the percentage of patients dropping out in U.S. studies (10.5%) was higher than in non-U.S. studies (7.6%); known location of dropout patients in U.S. studies was 1.7%, compared to 2.6% in non-U.S. studies. The most interesting finding was that no suicides were reported in U.S. studies, compared to 0.6% of patients reported in British studies. Some U.S. studies used ‘challenge doses’, such as amphetamines or L-dopa; no non-U.S. studies reported their use. Compared to U.S. studies, those by non-U.S., and particularly British, researchers appeared to report adverse events in their studies. ‘Challenge’ drugs were not used; suicides were reported. It is estimated that the probability that no patients suicided who participated in the U.S. is small—one in 500.
Keywords clinical research ethics  protocol design  informed and proxy consent  schizophrenia  relapses  suicides  integrity of research data  Institutional Review Boards
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