One source who attended the meeting says the panel raised a lot of questions about the industry’s desire to jump from mice straight to human trials. David Prentice of the Family Research Council says reports are that the FDA seemed skeptical.
“A lot of the evidence they heard had to do with safety. Obviously embryonic stem cells, one of the big risks is tumors.”
Prentice said the FDA appears to still be a long ways away from approving therapies derived from embryonic stem cell research, although some researchers would like them to.
“I think they’re getting a lot of pressure from patient advocacy groups and companies and scientists who want to do human embryonic stem cell research.”
Dr. Michael Sleasman of the Center for Bioethics and Human Dignity says the FDA is going to have to get involved sometime.
“Unfortunately this research is going forward whether or not we like it, and so it is important that the FDA establish safety standards.”
Bio-ethicists will be watching to see that profit-driven pressure from pharmaceuticals don’t convince the FDA to fast-track the process.
“There’s a whole host of issues that surround FDA approval, and I think it calls for us to be extremely vigilant and careful.”
It wasn’t that long ago that the FDA bowed to similar pressure and fast-tracked the abortifacient RU-486. To date seven women in the US have been killed by the drug.