Some in the ESCR community–and I am referring to those without moral objections–are worried that the coming ESC human trials are premature. From the story:
Scientists are poised to inject cells created from embryonic stem cells into some patients with a progressive form of blindness and others with devastating spinal cord injuries. That is a welcome step for researchers eager to move from the laboratory to the clinic and for patients hoping for cures. But beyond being loathsome to those with moral objections to any research using cells from human embryos, the tests are worrying many proponents: Some argue that the experiments are premature, others question whether they are ethical, and many fear that the trials risk disaster for the field if anything goes awry. “We desperately need to know how these cells are going to perform in the human setting,’’ said John Gearhart, a stem cell pioneer at the University of Pennsylvania. “But are we transplanting cells that are going to cause tumors? Will they stay where you put them and do what you want them to do?’’…
They cite the case of Jesse Gelsinger, whose 1999 death from a gene therapy experiment set that once highly touted field back years. “There’s a lot of angst around these trials,’’ said Evan Snyder, director of the stem cell program at the Sanford-Burnham Medical Research Institute in San Diego. “There’s going to be this perception that if the cells do not perform well, the entire field will be illegitimate.’’ Most of the apprehension focuses on the Geron trial. Safety worries — most prominently fears that the cells could cause tumors — prompted the FDA to repeatedly demand additional data from Geron, including most recently assurance that cysts that developed in mice injected with the cells posed no threat.
It is my understanding that the product has only been tested on small animals like rodents, not larger animals, which seems to be validated by the article. If that is true, it could be a dangerous thing:
While Geron eventually hopes to test the cells on many patients, the first trial will involve 10 people partially paralyzed by a spinal cord injury in the previous one to two weeks. Surgeons will inject the first patient with about 2 million “oligodendrocyte progenitor cells,’’ created from embryonic stem cells, in the hopes the cells will form a restorative coating around the damaged spinal cord. In tests in hundreds of rats, partly paralyzed animals walked…
Officials at Advanced Cell Technology of Menlo Park, Calif., are hoping for the FDA’s go-ahead to start, possibly even sooner, injecting 50,000 to 200,000 cells into the eyes of 12 patients suffering from Stargardt’s macular dystrophy. Retinal pigmented epithelial cells, also made from human embryonic stem cells, should replace those ravaged by the progressive loss of eyesight, usually beginning in childhood. Studies in rats found the cells helped prevent further vision loss and even restored some sight.
It seems to me when tumors are an issue, the follow up to the cell injections should be over years, longer than those that can be done in rats and mice. Moreover, the physiological differences between rodents and humans are such that successful rodent testing is usually followed by tests in large animals such as primates or pigs before human trials begin. If these products haven’t been tested on large animals–in which the subjects could be followed for years–I think a big and potentially dangerous leap of faith has been made.
September 2nd, 2010 | 1:06 pm
[...] This post was mentioned on Twitter by Vince Humphreys, Wesley J. Smith. Wesley J. Smith said: Are Human ESC Trials Premature? » Secondhand Smoke | A First Things Blog http://t.co/y7BKAUT [...]
September 2nd, 2010 | 5:56 pm
Research on the eye has been carried out at ACTC for many years with no sign WHATSOEVER of problems and a 100% success rate on rats. The eye is the only part of the human body where as a result of Stem Cell procedure tumours will NOT develop. and they are not prone to rejection like other parts of the body. All advancements in medical science has to start somewhere and sometime. The results in UK and Europe using Stem Cells has been outstanding to say the least.
September 2nd, 2010 | 10:56 pm
Wesley, for what it’s worth, I must compliment you publicly for the great work that you’re trying to do. Of course not all History Righters will agree with my opinion but then again as you’ve said and shown so often, HR are entitled to their opinion.
I’ll close by saying that all we can really do is pray and hope that no one really jumps the gun cause between you and me, God does not need humanity to defend Himself.
Peace
September 2nd, 2010 | 11:41 pm
Wesley writes: “It seems to me when tumors are an issue, the follow up to the cell injections should be over years, longer than those that can be done in rats and mice.[...] If these products haven’t been tested on large animals–in which the subjects could be followed for years–I think a big and potentially dangerous leap of faith has been made.”
Wesley, I have found your blog to be encouraging because it brings to the fore many of the outstanding issues that have fallen off the radar, but I must say that your statements above all point to agreement with embryonic stem-cell research since by way of your logic testing should be done on a larger animals to be observed for a longer period before it is used on humans. Simply, your post is neither a rejection of embryonic stem-cell research nor an illumination of the lack of understanding which undergirds it. I understand we live in a world where this research does take place and so questioning has to occur, but I think the questions must continue to strive for the heart of the matter or the risk of acquiescing to the terms of debate you yourself have been trying to overcome greatly increases.
I have no doubt that stem-cell research will cure us of what ails us physically. The question that needs to be asked first is not if this kind of ‘leap of faith’ will physically cause harm to humans, but rather, what does all of this show us we have become?
Wesley J. Smith Reply:
September 3rd, 2010 at 12:03 am
Avdotya: I oppose ESCR because it treats nascent human lives as objects and mere natural resources, to the point I wrote a book about it: Consumer’s Guide to a Brave New World. Once such objectification begins, it won’t stop with the early embryo–as I’ve often recorded here.
And I am not at all sure that ESCR will “cure what ails us,” and in fact, believe there is room for significant doubt on that score. But if it is going to be done in humans–and I don’t see any way to stop it legally, there is no political will for that–it should be tested properly and not rushed to the possible physical detriment of test subjects. The two positions are not incompatible. Thanks for writing.
September 3rd, 2010 | 8:17 pm
ANY experimental medical procedure has risks. What’s critical is that there be informed consent on the part of the patient. From a practical standpoint we’ll never really know whether ESC therapy is (a) more or less effective than adult stem cell therapy, or (b) whether it works at all, until human medical problems are addressed. Someone had to perform human trials with adult stem cells; I see no reason not to give embryonic stem cells their “day in court” as well.
September 3rd, 2010 | 8:27 pm
Wesley: You’re concerned that “[i]f these [ESC-based] products haven’t been tested on large animals–in which the subjects could be followed for years … a big and potentially dangerous leap of faith has been made.”
Remember, the treatment is experimental and has presumably received the informed consent of the patient(s) involved. Furthermore, you may be underestimating the efficacy of computer modeling, which has become a major part of the testing protocols for new drugs. A related example: by now you’ve probably flown on a Boeing 777, the first commercial jetliner to receive FAA certification without a prototype having to be built. Both the design and testing were done entirely by computer.
Wesley J. Smith Reply:
September 3rd, 2010 at 10:34 pm
History Writer: These patients will be desperate people with new spinal cord injuries worried about a life of paralysis. If this hasn’t been thoroughly vetted, their consent isn’t the point.
September 4th, 2010 | 6:59 am
The longer some people try to prevent ESC therapy from being tested, the longer they’ll be able to claim it hasn’t produced any cures.
September 5th, 2010 | 11:17 pm
“What shall it profit a man, if he shall gain the whole word, and lose his own soul?”—Mark 8:36.
Isn’t that really the question being debated here today?
Wesley J. Smith Reply:
September 5th, 2010 at 11:37 pm
I think I should note for the record here that commenter “Raven” is not the same person as comenter “Raven Chukwu.” They clearly have different viewpoints and different e mail addresses. I am sure neither wants to be confused with the other. Thanks.
September 6th, 2010 | 12:10 am
Agreed. Just to add a little side note regarding organ transplantation. When I was dating my (future) husband 12 years ago I told him that in the not too distant future people would come to realize that organ transplantation is somewhat akin to the Frankenstein story. He thought I was crazy. (What kind of dating small talk is that anyway?) Nevertheless, he married me.
September 8th, 2010 | 9:39 pm
HistoryWriter writes: “The longer some people try to prevent ESC therapy from being tested, the longer they’ll be able to claim it hasn’t produced any cures.”
In one sense, I agree with you. The argument that “ESC therapy is ineffective” is a short-sighted and not terribly compelling tactic, since, given time and resources, ESC research may well prove to be a productive approach. I’d contend instead that ESC research is problematic because it could succeed. What then? The ends that justified the means in all likelihood would become (for many) justification for more of the means — demand for the raw materials that in Mr. Smith’s apt analysis “treats nascent human lives as objects and mere natural resources.”
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