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Advisors Raise No Stop Sign to Gene Therapy

WebMD Health News

March 10, 2000 (Bethesda, Md.) -- At the end of a grueling three-day meeting here, and without taking a formal vote, an advisory committee on gene therapy turned down a proposal Friday that would have halted gene treatments except for patients in life-or-death situations.

The move is not a direct affirmation of the controversial type of research. But allowing it to continue sends the message that there still is value in this type of study -- even when no one is sure of its benefits or what it might cost to achieve them.

"What we don't want is another Jesse Gelsinger," activist Jeremy Rifkin told the committee. Rifkin's group, the Foundation on Economic Trends, has been a long-time critic of gene research. Gelsinger, the 18-year-old who died after suffering a severe reaction to an experimental gene therapy last September, captured headlines and shocked researchers who had touted the gene therapy's relative safety for the last decade. It was the first death attributed to genetic treatment. The FDA halted the trial in January.

Rifkin's original letter to the Recombinant DNA Advisory Committee (RAC) last November asked that the RAC "impose an immediate moratorium on the consideration of any future human ... gene therapy ... except where the protocol can legitimately be considered a treatment of last resort for a life-threatening illness."

Committee members, however, argued against stopping gene research on people, fearing such action also would stop some useful, but low-risk, research. "I think [a moratorium] comes perilously close to saying that terminally ill subjects are expendable," panelist Nancy King, JD, of the University of North Carolina, told the committee.

In a surprise move, Jesse Gelsinger's father, Paul, appeared before the RAC earlier in the day and made a plea for a national center to protect patients' rights. He told the RAC he thought his son was doing everything right. However, the senior Gelsinger later came to believe that the researchers at the University of Pennsylvania who performed the treatment to correct an inherited liver disorder glossed over the experiment's risks. Those risks proved to be fatal.

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