The main U.S. professional society representing gene therapists argued this week that clinical trials in their maturing field should no longer be required to undergo review by a special federal advisory committee. Although others disagree, many say it's time to take a fresh look at the role of the venerable Recombinant DNA Advisory Committee (RAC).
RAC was created in 1974 to oversee all gene splicing experiments, then later shifted its focus mainly to human gene therapy. In the mid-1990s, then-National Institutes of Health (NIH) Director Harold Varmus questioned whether RAC was needed, and its mission was changed from approving protocols to offering advice. But any NIH-funded researcher who proposes a gene therapy trial is still required to send a thick application to the RAC's 21 researchers, ethicists, public representatives, and others for review. The committee selects about 20% of the 50 to 100 protocols it receives each year for discussion at its public meetings. The RAC also oversees institutional biosafety committees and updates NIH's guidelines for working with recombinant DNA.
But now after 20 years of experience, more than 1000 U.S. trials, and a growing number of gene therapy successes in the clinic, some researchers say it's time to end RAC review of gene therapy protocols. One big reason, they say, is that the proposals are already reviewed by the U.S. Food and Drug Administration and institutional ethics and biosafety boards, which now have plenty of experience with the field. "Gene therapy is overregulated to the point where it's crippling progress," says Xandra Breakefield of Massachusetts General Hospital in Charlestown, president-elect of the American Society of Gene and Cell Therapy (ASGCT).