Human Drug Trials: How they work and why they are done that way, and attendant ethical issues
A feeling of responsibility to subjects in drug trials and that he is making a contribution to safe drug led Dick Kelley ten years ago to become a member of the Institutional Review Board at Newark's Beth Israel Hospital. He is one of the two non-scientist members of the board.
Kelley described the methods in use today to test drugs for toxicity and efficacy and that his role on the IRB is to determine if the test results are as actually reported.
Phases 1-4, starting after animals have had drugs tested on them, help drug companies to determine the safety of their products before being approved by the FDA for general use. In these phases toxicity, efficacy, side effects, and specific uses are tested using human subjects. These subjects today are always voluntary, informed and, at some stages, actually suffering the diseases the drug is designed for. In spite of this rigorous regimen, Kelley stated that he sometimes does not think that the procedure is as good as it can be.
The attendees at the dialog expressed some doubts as to the procedures also, but generally were reassured by the presence of people on the board such as the speaker that here in the United States all possible is being done to assure drug safety and efficacy.
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UNITARIAN UNIVERSALIST CONGREGATION OF MONMOUTH COUNTY