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Advisors Raise No Stop Sign to Gene Therapy


Still, after considerable discussion, RAC panelists insisted that the scientists provide more data about how this new treatment delivery system would work in animals and whether the replacement gene would really function correctly. The situation proved particularly frustrating for the Karlins, because they feel they know the risks and the benefits as well as anyone.

Ironically, the Karlins believe Jesse Gelsinger's death may have created an environment that is endangering their daughter. "Unfortunately, the bureaucratic element often interferes in these protocols, and what happens is that the ethical rights of these children ... [are] violated," says Helene Karlin.

Though the Karlins say they hope that their daughter will get started in a new gene trial in a couple of months, the process has made them angry. "Death doesn't wait for meetings, and that's what we object to," says Helene Karlin.

In spite of the pressure to come up with new procedures to publicize adverse events from gene trials, the committee couldn't reach a consensus on how much information researchers should report and when, even though it was a top priority of the meeting.

"We'll pound it until we come to agreement, and the things to agree on initially are, 'What will we do with the data and what purpose will it serve?'" RAC chairwoman Claudia Mickelson, PhD, tells WebMD.

But for Paul Gelsinger, the wait for answers about what happened to his son has already been agonizing. "I think it's remarkable that they don't have real answers yet," he tells WebMD. "That to me is totally amazing."

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