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WASHINGTON - Following a setback in gene therapy experiments in France, U.S. health advisers are recommending the treatment be given only to children who have no other alternatives.
The Food and Drug Administration convened its advisory panel after a 3-year-old French boy became the third child to develop cancer following gene therapy for treatment of X-linked severe combined immunodeficiency, or X-SCID. The FDA had asked U.S. researchers doing similar work to put it on hold.
Doctors and scientists on the advisory panel said they didn't want to hold up the therapy for children who have already failed to respond to bone marrow transplants, an alternative treatment. But they noted that the number of such children _ who under Friday's recommendation would still be able to have experimental gene therapy _ is very small.
"What is happening here today _ the big picture _ is that it shows the difficulty in developing any new class of therapy," said Dr. Daniel Salomon, a member of the panel and a professor at the Scripps Research Institute.
"There was a period of time that...
The Food and Drug Administration convened its advisory panel after a 3-year-old French boy became the third child to develop cancer following gene therapy for treatment of X-linked severe combined immunodeficiency, or X-SCID. The FDA had asked U.S. researchers doing similar work to put it on hold.
Doctors and scientists on the advisory panel said they didn't want to hold up the therapy for children who have already failed to respond to bone marrow transplants, an alternative treatment. But they noted that the number of such children _ who under Friday's recommendation would still be able to have experimental gene therapy _ is very small.
"What is happening here today _ the big picture _ is that it shows the difficulty in developing any new class of therapy," said Dr. Daniel Salomon, a member of the panel and a professor at the Scripps Research Institute.
"There was a period of time that...