FDA Delays Geron’s Human Embryonic Stem Cell Research Trials, Seeks Data
by Steven Ertelt
LifeNews.com Editor
August 18, 2009
Washington, DC (LifeNews.com) — The Food and Drug Administration is delaying a bid by biotech company Geron to become the first to conduct human trials with embryonic stem cells. The move is drawing applause from pro-life advocates who oppose the use of the cells because they involve the destruction of human life to obtain.
Geron officials said today that the FDA is reviewing new data from studies of the therapy, called GRNOPC1, in its use with animals.
Scientists and pro-life advocates say human embryonic stem cells are not ready for trial because problems associated with the cells in animals haven’t been solved. The embryonic stem cells still cause tumors and have issues with the immune system rejecting the injection of the cells.
Geron had planned to begin the trials this summer but said it will halt that pending the FDA review and did not know how long it would take the regulatory agency to conduct its evaluation.
The FDA initially cleared the trials in January, which would involve 8 to 10 patients.
Embryonic stem cell research has never cured or helped any patients to this point. Only the use of adult stem cells and treatments derived from them have cured or reduced the effects of any diseases or conditions afflicting patients.
Geron Corp., based in California, will use the treatment with 10 spinal cord patients with injuries the company hopes to treat with an experimental drug containing embryonic stem cells.
The patients in the trial will be ones who can receive treatment within 14 days after a spinal cord injury has left them paralyzed. They will need to be followed for a year to determine if the treatments had any effect.
Evan Snyder, a neuroscientist who heads up the stem cell research center at the Burnham Institute for Medical Research in San Diego, warns that the research may not be ready for humans.
"There’s a lot of debate among spinal cord researchers that the pre-clinical data itself doesn’t justify the clinical trial," Snyder, who is working on using neural stem cells himself, says.
Snyder says the mice Geron used to conduct pre-human trial research had more excessive injuries that scientists would normally prefer to see prior to trying the procedure on human patients.
He suggests that Geron should have done experiments involving larger animals before seeking FDA permission to use the controversial embryonic stem cells in humans.
Those concerns existed as early as 2005 and may not have been addressed. https://www.lifenews.com/bio1185.html
Snyder said then that Geron should do more animal testing first to make sure the tests would be on the same injuries humans have.
"I’m not convinced they have done that yet," Snyder said.
Jerry Silver, a neuroscience professor and stem-cell researcher at Case Western Reserve University in Cleveland, told Knight Ridder back in November 2005 that Geron was moving too fast and needed to do more tests on animals before seeking human patients.
"Frankly, I cannot conceive of a human trial with the use of human embryonic stem cells following immediately from experiments in rodents only," he said then. "Many treatments that work in rodents to alleviate disease fail miserably in humans."
Bioethicst Wesley J. Smith said in January that he’s concerned the FDA didn’t make Geron offer more proof its experiments were ready for human trials.
"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," he said.
Smith is worried the decision may have been made for political rather than scientific reasons — ironic given Obama’s complaint that the Bush administration did the same thing.
He said some noted the decision may have been 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," he says. "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."
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