Two longish articles by our old friend Dr. Carl Elliott and by Peter Aldhous:
--raise interesting questions about clinical research on pharmaceuticals.
Dr. Elliott addresses the selection of subjects for research on new drugs, and shows that in many instances, they are taken from places that raise suspicions about the quality of the research--such as homeless shelters, and other places that have a high incidence of mentally ill. Aldhous looks at the credentials of the physicians who do this research and shows that some cases, the physicians have been disciplined for serious violations.
Perhaps the best short summary of these two pieces appears toward the end of the Aldhous piece:
"Some experts agree that the FDA's entire rulebook for clinical trials, with its talk of things like 'institutional' review boards, reflects the academic past of clinical research--not today's industrial juggernaut of for-profit clinical trials firms and for-hire review boards, which oversee a workforce of doctors drawn from regular medical practice. 'They are regulations for a world that doesn't exist anymore,' says Elizabeth Woeckner, president of Citizens for Responsible Care and Research, which campaigns for the safety of medical research volunteers."
Therefore, when one reads that scientists have tested new drugs on patients and have yielded the following information, one has to wonder, first, whether those "patients" actually have the diseases the scientists are studying and have honestly reported their status (as opposed to making up what seems most fitting for payment for inclusion in the study, and getting away alive afterwards); and second, whether those "scientists" are properly trained physicians and can observe the variables required. There seems little concern, presently, to reassure the public that either is the case.
Tuesday, July 29, 2014
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In the early days (1960s - early 1970s) a lot of Phase I drug development studies were done in prisons. No longer.
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