Rodin: charges 'strong'

An external committee to review the IHGT will be in place by Monday. University President Judith Rodin acknowledged yesterday that the federal government's recent allegations of research protocol violations by Penn's Institute for Human Gene Therapy are serious and demand investigation. "At this point, we believe the allegations of the FDA are strong and merit consideration," Rodin said in an interview yesterday. Rodin would not comment on how the study's 18 alleged procedural violations could have been committed at Penn's Institute, which until now was considered one of the best in the world. The allegations include not fully disclosing to patients the risks involved with the study, including patients who were ineligible to participate and failing to tell the FDA about setbacks that could have caused the agency to halt the study. Penn has an internal Institutional Review Board, which approves all human research trials before they begin, and Rodin would not say how the alleged violations could have been committed with this check system in place. "We have every reason to believe and expect that the review process was complete," she said. An external institutional review committee -- which Rodin requested last week in response to the U.S. Food and Drug Administration's decision to place a moratorium on all gene therapy studies at Penn -- will be in place by Monday at the latest, she said. Rodin said the University is taking the FDA findings "very seriously" and that Penn has been cooperating with the FDA and other agencies in their investigations. Provost Robert Barchi is currently in the process of appointing outside experts to the committee, which will advise Rodin on the IHGT's procedures for conducting gene therapy studies and give her information on how to proceed in the future with gene therapy research at Penn. The panel will consist of five or six scientists and investigators not associated with the University, Rodin said, and will attempt to conclude its review in the shortest time possible. "We're going to ask them to work quickly," she said, adding that the committee will be expected to complete its work in six to eight weeks. Professor Emeritus of Infectious Diseases Nicholas Kefalides, who serves as executive chairman of all of the University's Institutional Review Boards, said he did not know of any other case in the past 30 years in which outside experts had been called in to review research conducted by Penn. "It is obvious that if the University decides to review the gene therapy process, there has to be a committee of experts, non-biased individuals, to advise the president accordingly," Kefalides said. Several other professors said yesterday that they supported Rodin's decision to have a group of outside experts look into the IHGT's practices, noting that people not affiliated with Penn would provide an unbiased view of the situation. "I think it is an excellent idea," Chief of Neuroradiology Robert Grossman said. "Sometimes it is much easier for individuals outside an institution to investigate these issues." The FDA halted all Penn gene therapy studies last week after citing "numerous serious deficiencies" in the Institute's oversight and monitoring of the clinical trial in which Gelsinger was enrolled. In their two-page letter, the agency wrote that similar deficiencies in other studies could expose patients to a "significant and unreasonable risk." Rodin said the IHGT would be responsible for responding to the FDA's findings, adding that she did not know when the response would be made. A spokeswoman for the FDA said yesterday that the agency did not set any deadline by which the IHGT must respond, but that the studies would be allowed to start again only "when we have assurance that the trials are in accordance with FDA regulations." Paul Gelsinger, father of the Arizona teenager who died while participating in the study, was scheduled to testify before a U.S. Senate hearing about the field of gene therapy today, but officials postponed the hearing because of yesterday's snowstorm. Also yesterday, The Philadelphia Inquirer reported that Genovo Corp., the major backer for the IHGT, was considering withdrawing its funding from Penn. IHGT Director James M. Wilson's financial involvement with the company -- which has a deal to develop gene therapies for lung and liver disease -- has been criticized since Jesse Gelsinger's September 17 death, with some saying that his incentive to test a product prompted unethical behavior. But yesterday, Genovo spokesman Fred Spar disputed the article, saying that the corporation "has no plans to change its funding relationship" with the Institute. Daily Pennsylvanian staff writers Eric Dash and Joshua Liez contributed to this article.