External overseers named

A committee of distinguished research scientists from across the country was appointed by President Judith Rodin to review the oversight and monitoring of clinical trials at the Institute for Human Gene Therapy (IHGT) at the Medical Center.

William H. Danforth, M.D., chancellor emeritus and vice chair of the board of trustees at Washington University in St. Louis, will chair the committee, which was formed after the Food and Drug Administration suspended eight clinical trials and cited multiple violations of federal research protocol at the IHGT. IHGT is responding to the citation.

Asked about the effect his committee may have on human gene therapy trials at Penn and nationwide, Danforth e-mailed, “We are collecting documents, but have not as yet met. I have no opinion at this time other than I believe it is admirable for the University to open itself to an outside group.”

The September death of volunteer research subject Jesse Gelsinger at the IHGT triggered the FDA’s action.

It also triggered across the country an examination of the monitoring of human gene therapy clinical trials.

In the wake of Gelsinger’s death, the National Institutes of Health (NIH) has been swamped with more than 600 incident reports from gene therapy trials throughout the country, newspaperd reported.

IHGT reported Gelsinger’s death promptly to both the FDA and the NIH.

Other committee members are:

Joseph B. Martin, M.D., Ph.D., dean at Harvard Medical School;

Edward J. Benz Jr., M.D., Sir William Osler Professor and director of the department of medicine at Johns Hopkins;

Inder Verma, Ph.D., American Cancer Society Professor of Molecular Biology, Salk Institute, La Jolla, Calif.;

Rochelle Hirschhorn, M.D., professor of medicine and cell biology and chief of the division of medical genetics at New York University School of Medicine’s department of medicine; and

Daniel Callahan, Ph.D., director of international programs, The Hastings Center in Garrison, N.Y.

The committee’s charges include evaluating IHGT’s oversight and monitoring of clinical trial programs, with particular emphasis on the FDA’s findings and the IHGT’s response to those findings.


Originally published on February 17, 2000