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

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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.

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Shamoo, A.E., Irving, D.N. & Langenberg, P. A review of patient outcomes in pharmacological studies from the psychiatric literature, 1966–1993. SCI ENG ETHICS 3, 395–406 (1997). https://doi.org/10.1007/s11948-997-0043-1

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  • DOI: https://doi.org/10.1007/s11948-997-0043-1

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