Was the FDA's ESCR Human Trial Approval Political Rather Than Scientific?
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.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:
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
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.
Labels: Embryonic Stem Cell Research. Human Trials. Geron. FDA. Politics.
posted by Wesley J. Smith @ 2:34 PM
14 Comments
14 Comments:
Sorry, I have long believed that the FDA doesn't do anything really ethical; that its decisions are mostly to protect its own butt in order to keep going as the FDA...in order to protect its own... you get what I am saying.
I do not trust the FDA at.all.
I don't know if it was political either, but the timing was VERY coincidental... it could not have been more perfect...
I'm not an FDA enthusiast either. Nor of animal testing, period. Those poor larger animals, and we don't even know if THAT would be useful.
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This is ugly, but I have to say that there's no reason to be surprised if it was political if you are a veteran pro-life anti-abortion advocate. RU 486, the chemical abortion pill (called a medical abortion because it's a pill)was pushed through faster than it should have. I predict that in the future we will have a biotech version of the abortion movement that crafts a bill to protect the industry like the Freedom of Choice Act. FOCA will wipe out virtually every law/regulation limiting abortion even if it makes it safer for women. There will be biotech advocates likewise urging laws to wipe out all limitations on ESCR and Cloning, even if it is intended to protect the human "subject" partly because they can brook no dissent and too much money is at stake.
The FDA lets through one pharmaceutical product after another that is too new and has lethal side-effects and at the same time blocks things that are harmless and beneficial. On the face of it, it looks as if the FDA panders to the pharmaceutical industry and the U.S. medical establishment, and an agenda seems apparent, plus is just plain lazy and inefficient. The whole agency seems to need a radical revamping.
Sorry, folks, it's nothing that sinister. This is a SAFETY trial, not an EFFICACY trial. It's very preliminary, and its primary purpose is to make sure the treatment is not in and of itself harmful, regardless of any beneficial effects.
If it passes safety tests it will proceed to animal-based efficacy testing, and if the results of that study show promise in translating to humans, then they go to human efficacy testing.
Your point seems to be that larger animals should've been used for research first, such as what animal..?
Shall we capture more monkeys to experiment on when there are willing human volunteers who have a choice? I think no.
What is wrong with using the mouse model that you criticize? What does size of the animal subjects have to do with success in human models?
Mouse DNA is very similar to human, so getting an large bear or rhinoceros to repair a spine wouldn't necessarily help anymore than a mouse, likely less.
DS: My point is that some pro ESCR people apparently think this might be precipitous. If so, the decision might be political. I hope not!
I still think that the non-human animals should be left out of it. If they could be asked and could answer, they'd say likewise, and that they can't makes it even more heinous that they are used.
And being willing to be heinous toward them is what has brought us "futile care," euthanasia, general medical callousness, the death culture, etc. When something is wrong, causes suffering, etc., the same comes out of it and there is no way around that. It's not a matter of survival to do it, it's a matter of "quality of life," and there it goes again, the circle.
I wrote about this elsewhere and wondered why they didn't do the experiment on primates, and then joked that if they kill embryos and then implant the untried risky treatment into the handicapped, everyone calls them a hero.
But if they kill an ape embryo and implant it into a paralyzed primate, they will probably have their house firebombed...
I was joking, but sometimes you wonder about these things.
I'll take the right of the primate, and of the primate embryo, not to be messed with over that of the human embryo. The ape can express objection and obviously can feel, and the ape embryo has the capacity to grow into a being more honest and less capable of acting like creeps than we are.
Boinky: There is no parody far enough out that they won't catch up with you. At least that is what I have learned these last several years.
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