Eck, the codirector of the Cancer Gene Therapy Programs of IHGT and the Ann B. Young Assistant Professor of Medicine, stood in for James Wilson, M.D., director of IHGT, who was originally scheduled to speak. Because of issues surrounding the Sept. 17 death of 18-year-old Jesse Gelsinger, a participant in an IHGT experimental gene therapy trial,Wilson was unable to attend.
The speakers touched only lightly on the specific subject of Gelsingers death, which caused the federal Food and Drug Administration to shut down human trials at IHGT Jan. 21. The hour-and-a-half forum, titled Will the Re-Engineering of Human Beings Re-Engineer Human Nature?, covered subjects such as discrimination based on genetics, eugenics, and human nature and its malleability, as well as some general topics related to Gelsingers death whether human trials were properly monitored and whether subjects were sufficiently informed of possible dangers.
Caplan, who is also chief of bioethics at the Health System and Trustee Professor of Bioethics, stated, It would be a miracle if any subject in a Phase I clinical trial, the type Gelsinger participated in, received any benefit from the experiment. He said that scientists do not do enough to inform their subjects about the risks in these trials. He stated that the monitoring of human subjects overall, not only in gene therapy trials, was very poor.
These statements drew sharp criticism from audience member Matthew During, M.D., director of Jefferson Medical Colleges Gene Therapy Center and a professor of neurosurgery. A Phase I trial does not mean an individual will not get any benefit, he said. Human trials have tighter regulations and control over them than any other trials, he said.
Eck characterized some of Caplans statements as purely ridiculous. He said, There is a grain of truth in what Arthur said, but its not the whole truth and nothing but the truth.
Originally published on February 17, 2000