Traber out; U. seeking successor

The University's troubled Institute for Human Gene Therapy faced more than its share of difficulties this summer as Penn administrators decided to end all of its clinical trials and federal regulators issued a warning letter against the Institute's animal research laboratory. In addition, officials announced that Genovo, Inc. -- a provider of 20 percent of the Institute's funding and whose relationship with IHGT Director James M. Wilson had been perceived as a conflict of interest -- will be acquired by Targeted Genetics Corporation. In a prepared statement, Wilson -- who received Targeted Genetics stock worth about $13.5 million with the deal -- said he had no role in the merger decision and added that he will remain a full professor at Penn. The IHGT has been highly scrutinized by the media for most of the past year following the September 1999 death of 18-year-old Jesse Gelsinger in an IHGT clinical trial. The Food and Drug Administration placed a hold in January on all clinical trials at the Institute, which until then was one of the largest and most respected of its kind. At the end of May, University officials 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 same month. And on July 3, the FDA sent a 15-page warning letter to Wilson outlining protocol violations in the Institute's animal research laboratory and ordering the IHGT to respond to the allegations within 15 business days. The letter said that, among other things, researchers used outdated, expired viruses to test the material's toxicity -- a move that may have led researchers to underestimate its toxicity. FDA investigators also stated that IHGT personnel euthanized mice, but reported that they found them dead in their cages. The letter also attacked the Institute's animal research data, claiming it was full of inconsistencies and errors. The warning came as a result of an ongoing investigation of three animal research projects at the IHGT. "We have already agreed with the FDA that there are instances in which oversight could be improved," Provost Robert Barchi explained in July. "We take these matters very seriously, as does everyone in the IHGT. They are committed to taking care of the issues at hand." University spokesman Ken Wildes said this week that Penn has replied to the FDA's letter, but would not reveal its contents. The merger of Genovo and Targeted Genetics, which was announced early in August, put the media spotlight back on the IHGT. Speculation on conflicts-of-interest concerning Wilson's involvement with an outside company and his academic research at Penn had surfaced with Gelsinger's death but may have ended with the merger. Wilson, the founder of Genovo, will receive Targeted Genetics stock worth about $13.5 million at closing on August 9, according to The Philadelphia Inquirer. The University is also reported to be receiving stock worth about $1.3 million at the closing. According to Stephen Eck, the co-director of cancer gene therapy programs at the IHGT, the IHGT's funding will not be impacted by the merger. Eck defended Wilson's involvement with Genovo during the Gelsinger trial. "This is a very well-paved road," Eck said about partnerships between university researchers and private companies, citing the University of Wisconsin's benefit from the use of some very common drugs developed there. "The system that is in place was very well worked out by the University. It's hard to call a foul on that," Eck said. "I don't think there is any credible data to suggest that anything was fudged.

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