Geron ESCR Drug Approved for Human Trial
Well after years of saying it was coming, finally Geron got permission to attempt a human trial of its ESC-derived drug for acute spinal cord injury. (This is not a direct infusion of stem cells, but of a type of adult neural stem cell created by differentiating the ES cells.) This is not an efficacy trial, but a safety trial, and will only target patients with new injuries since it did not work in rats with older paralysis. From the story:
Although the FDA says it does not make decisions based on politics, the company made the decision public just days after Obama was sworn into office. Stem cells are the body's master cells, giving rise to all the tissues, organs and blood. Embryonic stem cells are considered the most powerful kinds of stem cells, as they have the potential to give rise to any type of tissue.The story doesn't mention it, of course, but adult stem cell therapies have been in human trials for several years for paralysis caused by spinal cord injury--and the first peer reviewed study showing a restoration of feeling never received the coverage in the media that Geron has received repeatedly for years about this prospective trial--apparently because our news censors believed they were the wrong kind of stem cells.But they are difficult to make, requiring the use of an embryo or cloning technology. Geron and some other companies have been pursuing the goal without the use of federal funds.
And this part of the story make my Nader genes itch and illustrates vividly what has gone so wrong in this field--it is utterly market/stock obsessed:
Shares of Geron rose nearly 30 percent to $6.75 in premarket electronic trading on Nasdaq.One can't and shouldn't wish this trial bad luck--people's health is involved. But one can hope that if this drug proves safe in humans--still a big if--and if it works--perhaps a bigger if--its benefits are soon swamped by methods of treating spinal cord injury that are ethical and don't require the destroying of nascent humans to help those who are not in the developing stage.
posted by Wesley J. Smith @ 8:12 AM
25 Comments
25 Comments:
Just as important is the mis-representation of this being a true "ESCR trial" which I'm pretty sure most people interpret to mean the actual injection of ESCR cells. That's what I assumed when I heard it on CNN Radio this morning. Since the safety concerns about ESCR has everything to do with their direct injection and cancerous growths and the such, this news is in no way a statement that ESCR is looking more safe than it did in the past.
It would be more likely that its benefits were swamped by more ethical methods if it were addressed that the rats' "older" spinal cord injuries and the rest of what gets done to non-human animals is unethical. Once experimenters have free rein to do as they please to any living being, human life is devalued and gets swept up in the syndrome, and it doesn't matter how noble the objective is; rationalization is never more than rationalization and ethics are ethics, period. This is an example of how our own self-interest is involved in opposition to the use of non-human animals in research. If it's not ethical to do it to us, it's not ethical to do it to them.
Speaking of safety, a hospital that removed someone who wanted to live from life support and has done likewise with others just got fined heavily (by the standards of the amounts for which hospitals get fined, anyway) by OSHA for violations of safety standards re an incident in which a graduate student working in its laser lab sustained a head injury that put him in the Kessler Institute in New Jersey; when he comes home he's going to need round-the-clock care; a few years ago an undergraduate at that university who had volunteered to participate in a paid research study on a new drug died during the course of the experiment. Laxity, incompetence, disorganization, negligence, carelessness, lack of respect, etc. go across the board.
It seems disingenuous for "pro-lifers" to trumpet the success of adult stem cells while claiming that embryonic stem cells have yet to cause a single cure. For the past several years, thanks to the Bush administration's pandering to religious fundamentalists, research in embryonic stem cell technology has been serisouly hampered.
I heard ABC's WORLD NEWS TONIGHT led off its Friday broadcast with this story, with, of course, no mention of olfactory tissue being used by Dr. Carlos Lima to treat spinal-cord injury, nor any other therapy that doesn't involve embryos. This human trial, even if successful, would merely replicate what has been done via other means.
"For the past several years, thanks to the Bush administration's pandering to religious fundamentalists, research in embryonic stem cell technology has been serisouly hampered."
Are you still peddling this fiction, HistoryWriter? There's nothing religious about preventing human beings from being killed.
bmmg: And there's everything right about it.
Another problem with what you're saying, HistoryWriter, is that all the Bush administration did was to stop federal funding for any new embryonic stem cell lines. This does nothing to private funders, so why don't we private funders them pouring all their money into ESCR?
In fact, there are around 40-60 of those embryonic stem cell lines around, and as far as we know, they can produce embryonic stem cells indefinitely. So the next question is, why don't those who one said stem cell lines share them with others so that more people can be working on finding cures? Well, I think Wesley hit on it above, and that is that it is all about money and obtaining a patent and becoming a multi-billionaire. If scientists were REALLY interested in cures, they could share their embryonic stem cell lines and hope that someone is able to find cures with them. But that doesn't happen because it's not, fundamentally, about cures.
Bobby: Again you hit the nail on the head.
If using embryonic stem cells doesn't work, it may be because nature didn't design things to work that way. Those cells belong to another being, at another stage of life, who has another use for them, and whom nature did not design to be accessible to us, and whose cells nature designed to be useful only to itself. As it does for all the other animals, everything we need for health, nature gives us, between the plant world, animals for those of us whose blood types require meat, and our own intellectual and mechanical abilities, and it has made it accessible to us. We've finally figured out that our own adult bodies contain what we need to heal (and we didn't need to bother embryos or other animals to figure that out); by the same logic another person's embryonic cells, whose energy is all geared to the growth of that one particular person, would not work. For this we need a college diploma or graduate degree? I don't think nature intended us to mess with embryos, do fertility treatment the way it's done today, etc., either. We wouldn't even have the kind of fertility problems we have today if we'd used common sense and cooperated with nature rather than creating unaesthetic (there's the index right there), toxic materials and a mess all around ourselves because we're just so, so exceptional and entitled, which equals greed and lack of logic, which equals the COD. In fact now "they" are finding (but the media hardly trumpeted it) that children born via ivf have, surprise, surprised, weakened immune systems. You want a chicken, don't break the egg before it hatches on its own. I am absolutely opposed to fertility medicine and messing with embryos, and I have yet to find good character in any of the doctors I know who practice in that specialty. This business with "research" and "experimentation" can be a sickness, and while I don't believe in the concept of sin, the greed behind it is just plain and destructive, and I think we need to do something about those people and not keep allowing them to have positions of respect and reward in this society.
I hear ya, Lanthe. Well said.
"If using embryonic stem cells doesn't work, it may be because nature didn't design things to work that way. Those cells belong to another being, at another stage of life, who has another use for them, and whom nature did not design to be accessible to us, and whose cells nature designed to be useful only to itself."
Dr. Carlos Lima (I believe) put it well when he explained that the function of embryonic stem cells is to proliferate, whereas the function of adult stem cells is to repair.
bmmg: If only the rest of them had as much insight and honesty as Dr. Lima does. It's common sense. Do they even KNOW that? It doesn't necessitate using laboratory animals to figure it out, either.
Bobby: I just saw your post. Thanks. You too.
Wow, that is a really good insight by Dr. Lima. It touches upon the vampire-esque-ness (if I may makeup a ridiculous word) of creating human life for the sole purpose of destroying it so that WE may live. We need the lifeblood of the weak to preserve ourselves.
Well what did we think would happen when they started using animals in laboratories and we let them, and it wasn't enough to steal dogs and cats from yards and take them out of pounds, no, they custom-breed them for the purpose as well, and breeding the beagles and rats and mice etc. is yet another big business now. As has become the prison system, because watch and see, the laziness, selfishness, and insanity that has corrupted us along with corrupting the scientific establishment is going to end us up with a fascistic state.
It most certainly IS vampiresque, and isn't the fascination with vampires in popular culture in the not too distant past interesting.
Remember when "the rabbit died" was good news and portended a "blessed event"? And look at the world we've ended up with. God forbid pregnancy should be discovered in its own time; people's own sense of control over their own bodies and lives had to be subservient to the doctor's and to the "wonders of science" and a rabbit the value of whose life was beneath consideration had to die. Not even a sacrifice to the gods that provides a feast after the entrails have been burned at the altar, just a rabbit has to die and end up in a medical trash receptacle. Any wonder why we now have to fear medical euthanasia? Women have been giving birth for as long as there have been humans without that malarkey, but now it made it "safer." Tyrranize them with "the wonders of medicine," make labor more of an ordeal with modern methods, mess with their bodies with environmental toxins, unnatural environments, work that isn't natural women's work, and physically disruptive contraception, and set them up to be grateful to "fertility medicine," and the next thing you know, embryos galore to experiment on. Very nice. And stupidly, people have gone along with it. Especially after having become so narcissistic that they feel entitled to "have" a child and willing to, in effect, buy one, and to prey on the weak so that they may "have better quality of life." Which leads right into the COD.
At November 12, 2008 , Blogger Dark Swan said...
ESCr is not HYPE as you repeatedly suggest, it is real and it is progressing rapidly. Soon enough you will be proven very very wrong. Clinical trials using ESCs in human to treat spinal injury are scheduled to begin shortly after the federal ban Bush signed which has prolonged human suffering is lifted by Obama's pen.
November 12, 2008 Blogger Wesley J. Smith said...
DS: As usual, you mix apples and oranges, making it hard to ignore you, since I don't want anyone to receive factually false information on this site. You said: "ESCr is not HYPE as you repeatedly suggest, it is real and it is progressing rapidly. Soon enough you will be proven very very wrong. Clinical trials using ESCs in human to treat spinal injury are scheduled to begin shortly after the federal ban Bush signed which has prolonged human suffering is lifted by Obama's pen."
The human trials are not yet scheduled. Geron has been promising human trials for that product "next year" for about five years now, as I have noted at SHS. The FDA has not yet agreed. It might happen, but it might not happen.
But carry on with your obfuscations. I believe in free speech.
November 12, 2008 Blogger Dark Swan said...
Well quite simply lets wait till spring and see if it happens or not.
-------------------
Well what a coincidence, Obama comes into office and less than a week later, HESC trials are scheduled to begin. Looks like the HYPE is going to get a chance to reach its potential.
Its telling that you even have to address your readership with a message that they shouldn't hope for a spinal cure via HESCs to fail - a sad culture.
"Clinical trials using ESCs in human to treat spinal injury are scheduled to begin shortly after the federal ban Bush signed which has prolonged human suffering is lifted by Obama's pen."
Two lies in one sentence: that Bush banned federal funding and that he has prolonged human suffering.
If the President can have say about this, then the President can ban animal testing. It's long since past time. Deal with that issue and this one won't be a problem.
The scope of Bush's policy towards ESCr is obvious to any genuine and intelligent person paying attention.
Bush severely restricted ESCr by banning federal funding of embryonic stem cell lines that were created after Aug. 9, 2001.
http://www.newscientist.com/article/dn16007-obama-plans-to-sweep-bush-stemcell-restrictions-aside.html
Bush vetoes embryonic stem-cell bill
http://www.cnn.com/2006/POLITICS/07/19/stemcells.veto/index.html
New federal grants, less red tape likely with reversal of Bush ban
http://www.baltimoresun.com/news/nation/bal-te.stemcell01dec01,0,4732524.story
US may lift ban on federal funding for stem-cell research
http://www.timesonline.co.uk/tol/news/uk/health/article617663.ece
Legislation to Reverse Stem Cell Ban Vowed by U.S. Lawmaker
http://bloomberg.com/apps/news?pid=20601124&sid=aybD9QaMvnDE&refer=home
House Votes to Reverse Ban on Funding for Stem Cell Research
http://www.nytimes.com/2005/05/24/politics/24cnd-stem.html
Good idea: quote from "news" sources that have it just as wrong as you do. There was no ban. A limit on the stem-cell lines eligible for federal funding, yes. A ban is something else altogether. I guess it makes it easier for lazy and/or dishonest reporters (of whom you are a de facto member) to call it a "ban" in order to get supporters' dander up.
There sure was a ban on federal funding for all stem cell lines created after Aug 9 2001.
Sorry simple facts are so difficult for you bmmg. You drown in variable semantics instead of focusing on the issue. Its a bad habit you have that distracts from the main point of many topics.
Ban -
2: to prohibit especially by legal means
Besides your distraction has nothing to do with the main point being made. Another failure to add any real contribution on your behalf. Your only interested in arguments it seems, but your arguments are rather boring... do you have anything interesting to say about Geron, (you know, the topic)?
Doubt it.
Dark Swan: I'm getting totally confused here. I thought the issue you are concerned about was animal experimentation and that you saw the same contradiction in the doctrine of human exceptionalism I do, but I guess it's stem cell research and I can't follow what's going on here about that.
"There sure was a ban on federal funding for all stem cell lines created after Aug 9 2001."
Limiting federal funding to those lines created before August 9, 2001 (one of which was used by Geron to lead to this "celebrated" human trial, by the way) does not justify this misleading headline:
"US may lift ban on federal funding for stem-cell research."
Were you awaiting a hearty endorsement of Geron, who's been saying for years that human trials for ESCs against spinal-cord injuries were just around the corner?
bmmg why do you insist on dragging this thread into your meaningless argument over the semantics of ban or limit? Your rant is remedial and has nothing to do with what the adults were discussing.
Geron's effort to bring the first HESC trial after years of effort was successful. I had speculated on this months ago on this blog. Wesley insinuated I was just offering up more unfulfilled promise of ESCR, that he'd heard it before and didn't think it would happen. I said lets wait and see because with Bush gone, the world would go from black and white to color. Again, I was right, so I said so. Then you clumsily interrupt by calling me a liar.
I don't need Geron to endorse me, I endorse them, so step off and recognize that attempting to call me out on a meaningless strawman tangent makes you look like a sour puss. Stick with the point son.
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