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Risk to trial subjects
Risks To Subjects 3 Mar 2k Lancet, 12 February 2000;560 (news item): Serving as a trial subject for a new drug or treatment protocol isn't always a free ride. The death of a gene-therapy (for liver disease) participant led to a lawsuit where plaintiffs claimed they were misled about efficacy and safety of the trial drug. Although federal rules require adverse trial events be reported to both FDA and NIH, they often are not. The FDA may order a halt to a trial, the NIH can only cut off funding. Responding to this case, the US Senate also got into the act, with a hearing on gene therapy. Cheers, Joe -- J. R. Bruman (818) 789-3694 3527 Cody Road Sherman Oaks, CA 91403-5013
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