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the main US professional society representing gene therapists have argued this week that the clinical trials their maturation area should no longer be required to undergo an examination by a special federal advisory committee. Although others disagree, many say it is time to take a fresh look at the role of the venerable Recombinant DNA Advisory Committee (RAC).
RAC was established in 1974 to oversee all gene splicing experiments, and later moved its primary focus on human gene therapy. In the mid-190s, then-National Institutes of Health (NIH) Director Harold Varmus asked whether the RAC was necessary, and its mission was changed to approve the protocols to offer advice. But all researchers funded by the NIH that provides gene therapy trial is even necessary to send a thick asked 21 researchers, ethicists, public representatives and other RAC members for review. The committee selects approximately 20% of 50 to 100 protocols it receives each year for discussion at public meetings. FCAC also oversees institutional biosafety committees and updates the guidelines of the NIH to work with recombinant DNA.
But now, after 20 years of experience, more than 1000 US trials, and a growing number of successful gene therapy in the clinic, some researchers say it is time to end RAC examination protocols gene therapy. A big reason, they say, is that the proposals are being examined by the US Food and Drug Administration and the institutional ethics and biosafety boards, which now have much experience with the field. "Gene therapy is over-regulated to the point where it is crippling progress," said Xandra Breakefield of Massachusetts General Hospital in Charlestown, elected president of the American Society of Gene Therapy and Cellular (ASGCT).
said ASGCT the two main concerns of safety altering the germ line DNA or by creating a new pathogen havent materialized vector for vectors that most trials are now using. in a recent letter to the RAC and Breakefield read a statement at a meeting RAC yesterday, the company said that instead of examining individual protocols RAC should instead focus on "new research areas."
This proposal got a mixed reaction from RAC members and others who submitted comments online. While many gene therapists agree, including European exchange-ASGCT some have suggested that the RAC exams are valuable to assess the safety and ethics of new therapies and can effectively review of speed other organizations. Commenters also welcomed the RAC value as a forum for public discussion that does not exist in other areas of clinical research. "It would be a mistake to underestimate the importance," said Claudia Mickelson, biosafety officer at the Massachusetts Institute of Technology in Cambridge.
The President of the RAC, Yuman Fong of Memorial Sloan Kettering Cancer Center, New York, urged caution: "To go to the examination most things to see there is a big step." He also noted that because no gene therapy treatments have been approved by the FDA, public confidence is "very important". At the same time, it is appropriate that the RAC should have a "dialogue" to whether it should "pare back" role.
Amy Patterson, NIH Associate Director for Science Policy, said the NIH has no plans to end the RAC "We still believe it is important to have this transparent forum. "But she said NIH is" happy to think of ways to simplify the process of RAC, "and is likely to welcome a broader discussion.
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