Researchers see FDA uncertainty behind hold on ESC work
The news that the FDA had put a ‘clinical hold' on Geron's plans to launch the first U.S. clinical trial of a stem cell therapy is attracting considerable scrutiny from researchers. The agency has yet to spell out exactly why it won't let Geron make the leap from preclinical work to a human trial. But Ole Isacson, a neuroscientist at Harvard Medical School, tells Nature that any outfit in Geron's position would have to offer convincing data that none of the transplanted cells could trigger a tumor or some other adverse event.
The problem in ESC research, he adds, is that no one has firmly established the criteria for that standard. Meanwhile, the FDA is still educating itself on the subject, and that is likely to give the agency pause before any human embryonic stem cell trials can be started.
At least one analyst, Steven Brozak of WBB Securities, has fretted that the Bush administration's objections to embryonic stem cell work may have forced the FDA's hand, but researchers say there's every reason to believe that the FDA simply doesn't know how to make sure the trials can be conducted safely. And that could prove to be a much bigger obstacle than politics for other ESC companies also looking to move into the clinic.
- read the article from Nature
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By Robert Jacklin | Posted 12:28am | May 21, 2008
Over a four year period Geron worked directly with the FDA to structure a test program that was given an unofficial green light by the FDA. It was aimed directly at proving the purity and safety of the derived cells planned for implantation.
It is astounding that after these four years of meetings, after testing more than 2,000 rats, including testing cells that intentionally included undifferentiated ESC's, with over 21,000 pages of test data that only now the FDA is publicly discussing what standard to use!
Incredible. Why did they waste Geron's time and limited money by misleading them for the last four years?
Private companies have limited resources. If the FDA wants to kill off any private sector development of needed therapies all they have to do is craete an atmosphere that approvals for tests will drag on forever to elimnate any company stepping forward, when to do so will guarantee its financial destruction, without accomplishing any good.
It appears the FDA is attempting to destroy Geron by foot dragging and delay, with the suffering patients of no importance. Is the FDA merely an extension of the Bush administration Faith Based Initiative.
Congress needs to hold hearings to get to the bottom of what is behind this problem in the FDA.
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