Experts react to changes in IHGT

The University's decision last week to end all clinical trials at the Institute for Human Gene Therapy has sparked discussion among gene therapists and medical experts nationwide.

The University last week declared that all human gene therapy trials will be conducted through individual departments and overseen by both the Office of Regulatory Affairs and an institutional review board, following suggestions given in a report issued by an external review committee.

The IHGT had already become the topic of nationwide medical debate after the death of 18-year-old Jesse Gelsinger in September as a result of his participation in a clinical trial at the institute.

The move to end clinical trials at the IHGT does not comes as a complete surprise to gene therapy experts.

"I think they had to demonstrate to a lot of people that they were taking [gene therapy protocol] very seriously," explained Matthew During, a gene therapy researcher at Thomas Jefferson University.

This sentiment was echoed by Jeffrey Kahn, the director of the University of Minnesota Center for Bioethics.

"It was in the range of things that many of us thought might happen," Kahn said, noting that the University's decision to end clinical trials at the institute was the "most stringent of all restrictions" it could implement.

Many experts said they thought that the University's actions were appropriate.

"When there clearly had been a breach in protocol, it's always best to halt research until all checks and balances are in place," During said, referring to Gelsinger's death.

But Lawrence Kedes, the director of the Institute of Genetic Medicine at the University of Southern California, said he though the decision was purely administrative and wouldn't have a significant affect on the ability of gene therapists to run clinical trials.

"The upshot of this is that it will have no impact on the quality or progress of trials," he said, adding that the University's decision was "strictly an administrative response."

Kedes also noted that USC follows a similar administrative mechanism in conducting research and that this hasn't impeded the ability of researchers to engage in clinical trials.

"I don't think this is going to affect anything," he said.

However, During said he thought the decision to end IHGT clinical trials was not aimed at the hindering the clinical trials of the University's gene therapists, but at IHGT Director James Wilson. Wilson -- the lead researcher in the study that led to Gelsinger's death -- will continue in his post at the institute.

The University is "rubbing the knuckles of James Wilson and his program -- not gene therapy at Penn," he continued, adding that "it could have happened anywhere to anyone."

This decision comes just months after the Food and Drug Administration halted IHGT clinical trials last January.

Jane Henney, the Commissioner of Food and Drugs, said in a statement that she was pleased with the changes made in the IHGT and the supervision of clinical research at Penn.

"The University of Pennsylvania's serious review of its clinical research operations is welcomed," she said. "This action underscores the importance of research institutions taking full responsibility for protecting and informing research subjects."

The changes made in how gene therapy is conducted at Penn are being felt at similar institutes throughout the country.

Kahn said that "there's been a strong increase in discussion and likely policy changes" since the University's announcement.

During agreed, adding that "the whole experience has put increased heat on all of us," he added.

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