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New Guidelines for Gene Therapy

Jesse Gelsinger was 18 years old when he died while undergoing experimental gene therapy at the University of Pennsylvania last summer. His death triggered a year of intense public scrutiny of the field of gene therapy, which aims to reverse genetic diseases by manipulating genes. On Thursday, the American Society of Gene Therapy issued new guidelines controlling conflicts of interest in research. Correspondent Elizabeth Kaledin reports.


Among the reasons for the outcry over Gelsinger's death was the discovery that the principle investigator in the trial, Dr. James Wilson, was heavily invested in the company, Genovo Inc., which was funding the research.


The case raised nagging questions over whether gene therapists, people at the helm of a new science with great potential, could be tempted to compromise patient safety in order to advance revolutionary science. A Congressional committee investigating conflicts of interest requested the University of Pennsylvania's related financial records.


"This is a very, very serious concern not only to the field of gene therapy but to all clinical researchers," said Savio Woo, president of the American Society of Gene Therapy.


The society's newly-issued guidelines are an attempt to control conflicts of interest.


A letter sent to all society members says, "All investigators and team members directly responsible for patient selection, the informed consent process and/or clinical management in a trial must not have equity, stock options or comparable arrangements... in companies sponsoring the trial."


Dr. Wilson declined a request from CBS News for an interview.


But he is by no means unique. In gene therapy research around the country there are complicated relationships between universities providing brain power and bio tech companies providing cash.


"You have to get your resources from somewhere," says Dr. Ron Crystal of the Weill Cornell Medical Center. "That's why most of the people who are involved in gene therapy have one sort of involvement or another relating to a bio tech company."


Dr. Crystal, a pioneer in gene therapy to treat heart disease, founded the company GenVec and owns about a two percent share in it. Asked if he had ever concealed adverse events from your trials in the interest of protecting your company, he replied, "Absolutely not."


Dr. Crystal says the new guidelines will affect him directly, but the guidelines are stricter than existing government regulations, and are expected to have a broad impact on the field.


"The key thing is to protect the integrity of the trial...as well as the patient," Dr. Woo says.


Perhaps the move will also restore some badly needed public faith in the science of gene therapy.

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