IHGT to no longer run clinical trials

The Institute for Human Gene Therapy will no longer conduct clinical trials, the University announced yesterday.

Instead, all trials will be run through the researcher's department, and will be overseen by the Office of Regulatory Affairs and an institutional review board. James M. Wilson will continue in his role as the director of IHGT.

"In my continuing role as Director of Penn's Institute for Human Gene Therapy, my colleagues and I will refocus our efforts in the preclinical area --ÿwith the goal of developing a foundation of science necessary to assure the ultimate success of this field," Wilson said in a statement.

Penn's gene therapy program has been under intense scrutiny since September, when 18-year-old Jesse Gelsinger, a participant in an IHGT clinical trial, died as a result of his treatment.

The Food and Drug Administration had already halted clinical trials at the institute in January.

Yesterday's decision by the University came in response to the release of a report by an external committee charged with examining the FDA's conclusions.

In its report, the six-person committee -- chaired by Washington University board of trustees vice chair William Danforth -- questioned both the necessity for the institute and the training level of institute staffers.

"Does it make sense to have an entire Institute devoted to gene therapy?" the committee asked in its report. "Are the risks well enough understood to promote widespread testing in inexperienced hands?''

Rodin said she agreed: "While we have moved aggressively in a variety of areas, we recognize that we have considerable work to do to ensure that we structure the best possible climate for clinical trials, one that always ensures the interests of our patients are of paramount importance.

"Penn and IHGT have jointly decided that IHGT can best serve the important future of gene therapy by resolutely focusing on molecular and cellular work and animal model experimentation."

Among other changes, the University will create a review board with special expertise in gene therapy, and will conduct a comprehensive review of the ethical decision-making surrounding using human subjects at Penn.

The existing Center for Bioethics will become an independent Department of Bioethics within the School of Medicine.

The Danforth committee, whose sole charge was examining monitoring procedures at IHGT, met twice in Philadelphia and interviewed twenty people familiar with IHGT clinical trials before making recommendations.

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