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Monday, March 03, 2003The suspended trials were a small but marquee group among the more than 200 US gene therapy patient experiments underway, cleverly using a common virus to deliver genes inside cells that could potentially treat cancer, HIV, multiple sclerosis, immune disorders, and other ailments. The use of the virus had actually worked well in treating so-called ''bubble boy syndrome,'' but the cancer cases made clear that the virus can do damage as well. But yesterday, a research panel convened by the Food and Drug Administration agreed the technique's healing potential outweighed the cancer risk. They voted, with only one ''nay'' among 21 members, to green-light the suspended trials. The endorsement, however, came with a caveat: Each gene therapy researcher involved in those trials must convince federal officials that all patients undergoing the experimental treatments are amply warned of its cancer risks. The gene therapy trials of severe combined immunodeficiency (the "bubble boy" disease), however, won't continue. Too great a risk of cancer in those. There was one lone dissenter in the vote to continue the research, however: The lone dissenter on that vote was John Coffin of Tufts University, who said that researchers still know little about the biology behind the cancerous side effects, and approvingly cited the cautious approach of another high-profile scientific probe. ''We're not going to send space shuttles up until we find out what happened to the Columbia,'' he said. It's true that no one understands what went wrong yet with the bubble boy gene therapy experiments, but it's also important to remember that these are experiments, and that they have inherent unknown risks. As long as the patients who are willing to take part in them understand that, then they should be able to go ahead. If we tried to eliminate all risks in experimental therapy, we would have no experiments. posted by Sydney on 3/03/2003 07:55:00 AM 0 comments 0 Comments: |
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