Was the FDA's ESCR Human Trial Approval Political Rather Than Scientific?
Posted Feb 03 2009 12:43am
When the FDA approved Geron's application to conduct human trials of their embryonic stem cell treatment for acute spinal cord injury, some noted that it might be political, coming as it did within days of the change of the presidential guard. I wasn't among those, but perhaps I should have been more cynical. Science has an article about the decision ("Celebration and Concern Over U.S. Trial of Embryonic Stem Cells Jennifer Couzin Science 30 January 2009: Vol. 323. no. 5914, p. 568--no link). This reaction from a stem cell research supporter should set off alarm bells:
Evan Snyder, a neuroscientist who directs the stem cell research center at the nonprofit Burnham Institute for Medical Research in San Diego, California, warns that a shaky start could set the field back enormously. "There's a lot of debate among spinal cord researchers that the preclinical data itself doesn't justify the clinical trial," says Snyder, who is working on using neural stem cells for drug delivery.
Among the concerns he cited: The rodents Geron studied had more moderate injuries than patients expected in the trial, suggesting that the results might not translate, and the therapy has not been tried in larger animals
Really? Why wouldn't the FDA require such work as they usually do in approving new drugs? Indeed, when the FDA said no to Geron last year, I expected successful larger animal work would be a necessary precondition to obtaining the FDA's approval. Here's the company's response from the article:
Keirstead and Okarma assert that, despite the criticisms, they've done everything they can before taking the next step. "There's nothing we can do but go to humans now," says Keirstead. Animal testing has its limitations, he adds--including the fact that there are no large animal models of spinal cord injury.
Perhaps one should have been devised. In any event, the FDA should be above politics. I hope that it was in this case. Otherwise, if things go wrong, the moral consequences will be on the commissioners' heads.