Govt. faults IHGT animal research

Federal regulators recently dealt another blow to the University's beleagured Institute for Human Gene Therapy.

On July 3, the Food and Drug Administration sent a 15-page warning letter to IHGT Director James Wilson outlining protocol violations in the Institute's animal research laboratory and ordering the IHGT to respond to the allegations with 15 business days.

University Provost Robert Barchi said yesterday that the IHGT is addressing some of the claims in the letter, noting that the Institute had already made changes in some of the problem areas cited in the warning.

The letter, which was made available on the FDA website on Tuesday, said that, among other things, researchers used outdated, expired viruses to test the material's toxicity. The use of outdated material may have led researchers to underestimate its toxicity, the letter said.

FDA investigators also stated that IHGT personnel euthanized mice, yet reported that they found them dead in their cages. The dead mice, according to the FDA, were missing key tissues.

The report also says that the laboratory improperly stored its data.

And the letter attacked the Institute's animal research data, claiming it was riddled with inconsistencies and errors.

The FDA ordered the IHGT to develop corrective actions to the problems cited by the agency's investigators within 15 business days of receipt of the letter. The warning came as a result of an ongoing investigation of three animal research projects at the IHGT.

This latest warning comes just over a month after Penn ended all IHGT clinical trials in late May.

The FDA had already placed clinical trials at the Institute on hold in January following the September death of 18-year-old Jesse Gelsinger in an IHGT clinical trial. Gelsinger was receiving an experimental gene therapy drug to treat an inherited liver disorder.

"The deficiencies observed during this inspection require corrective action," Director of the FDA's Office of Compliance and Biologics Quality Steven Masiello wrote in the letter. "This letter does not preclude the possibility of a corollary judicial proceeding or administrative action concerning these violations."

Barchi said that the process of responding to the letter would take time.

"It's going to take us probably several weeks to go through the letter in depth and in detail and prepare a point by point response to the letter," he said.

Barchi also noted that he thought that oversight of research at the IHGT could be improved.

"We have already agreed with the FDA that there are instances in which the oversight could be improved," he explained. "We take these matters very seriously, as does everyone in the IHGT. They are committed to taking care of the issues at hand."

An FDA spokesperson said yesterday that the discoveries were serious and needed correction, though it was too soon to tell whether the FDA would choose not to accept data from studies conducted at the IHGT because of the errors.

But Barchi said that the allegations in the FDA letter needed to be put into perspective.

"The toxicology research is only a very small part of the basic science research being done at the IHGT," he said.

"The University remains committed to the concept of gene therapy," he explained. "Gene therapy research at Penn is not just the IHGT."

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