Seeking Better Monitoring Of Research On Humans
March 2, 2000
The National Bioethics Advisory Commission, which is reviewing the safety and ethics of human research, wants better monitoring of medical experiments involving people. They are especially concerned over any failure to follow through and identify negative side effects of experimental treatments -- particularly in the field of gene therapy.
Gene therapies are designed to treat inherited defects by giving patients infusions of working genes. Concern with research practices has mounted since the death of a patient undergoing gene therapy at the University of Pennsylvania.
- The National Institutes of Health says there have been 691 "serious adverse events" in gene therapy experiments involving the use of adenovirus -- a weakened cold virus used to carry genes into the body -- but that scientists reported only 39.
- However Lana R. Skirboll, director of the Office of Science Policy, says the number for 1999 was 970 in adenovirus experiments, with an additional 100 in other gene therapy experiments.
- Since 1988, when there was only one gene therapy experiment, the total number conducted has grown to more than 300.
To date, there have been few reports of success in the therapies. But experts say there is still hope for devising treatments for a variety of conditions -- ranging from cancer to hemophilia.
Source: Phillip J. Hilts, "Panel Seeks Better Monitoring of Experiments Using People," New York Times, March 2, 2000.
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