For years, Geron promised that human trials for its ESCR derived product to treat people with new spinal cord injuries would begin–next year. Then approval was obtained from the FDA. Then it was off. Now, it is back on again. From the story:
Geron Corp. said Friday it was notified by the U.S. Food and Drug Administration that a clinical hold placed on the company’s Investigational New Drug application has been lifted and the clinical trial of GRNOPC1 in patients with acute spinal cord injury may proceed. Menlo Park-based Geron (NASDAQ:GERN) said it can now move forward with the world’s first clinical trial of a human embryonic stem cell (hESC)-based therapy in man. The Phase I multi-center trial is designed to establish the safety of GRNOPC1 in patients with “complete” American Spinal Injury Association Impairment Scale grade A subacute thoracic spinal cord injuries.
Adult stem cells have been used, so far with amazing success, in early human trials to restore feeling in long term spinal cord injury patients–with no fanfare at all in the MSM. But let’s focus on a different issue here: What if Geron’s product ultimately works?
ESCs are obtained by destroying nascent human life. This presents a problem for many medical professionals who believe it is wrong to destroy human life–even in the cause of treating the illnesses and disabilities of other human lives. Should physicians be able to refuse to prescribe ESC-derived products (or, years hence, products derived from gestating fetuses in artificial uteri or from euthanized infants) as a matter of conscience? I say yes, IF they advise patients ahead of time that there are certain approaches in which they will not engage based on conscience. Otherwise–and I think many would celebrate this turn of events–people who take traditional Hippocratic and/or pro life views to the practice of medicine, nursing, and pharmacology, will be driven out of health care. If that happens, society will be much the poorer for it. (More on my views on medical conscience, here.)
Health care did not used to involve such conflicts of interest. Now, with some procedures involving the active taking of human life, it does. And that is going to increasingly create profound conflicts of conscience in the medical sphere with which society is going to have to contend.
July 30th, 2010 | 4:35 pm
[...] This post was mentioned on Twitter by Vince Humphreys, Stand In The Gap and J. Robert Howell, Wesley J. Smith. Wesley J. Smith said: Geron On Again, Off Again ESCR Human Trial, On Again: What if Doctors Oppose? » Secondhand Smoke | A First Things Blog http://shar.es/mLN7p [...]
July 30th, 2010 | 4:48 pm
Mr. Wesley J. Smith:
I just read your story “Geron On Again, Off Again ESCR Human Trial, On Again: What if Doctors Oppose?” and noticed it contains the statement, “ESCs are obtained by destroying nascent human life.”
This statement is inaccurate, and needs to be corrected. While in the
past it was correct that HESC generation required human embryo
destruction, this is no longer the case. It has already proven that
human embryonic stem cell lines can be generated without harm to the
embryo by using techniques similar to the techniques used for pre-
implementation genetic diagnosis (the screening for diseases done in
fertility clinics) which have resulted in many thousands of healthy
births over the last few decades. Please review the most current
research & correct your story by removing that erroneous statement, it
is a myth that has endured for far too long.
Please see links below for reference:
links:
Cell lines NED1-NED4 being reviewed by NIH for federal funding
eligibility – NED stands for “no embryo destruction”
http://grants.nih.gov/stem_cells/registry/pending.htm
Peer-reviewed journal article:
http://www.cell.com/cell-stem-cell/abstract/S1934-5909(07)00330-X
http://www.advancedcell.com/documents/0000/0193/Lanza_Cell_Paper.pdf
(full article with study data)
There are many more links and news stories about this technology that
you should be able to easily locate with a Google search. Let me know
if you need assistance, ethical stem cell research is an interest of
mine.
Thank you for you prompt attention in this matter.
Best Regards,
D.M. Soboslay
Wesley J. Smith Reply:
July 30th, 2010 at 6:20 pm
Oh, please, DM Sobaslay. That’s a gimmick approach by ACT to get around the old Bush funding limits. Besides, the Geron lines were not obtained using the technique to which you are referring.
July 30th, 2010 | 7:34 pm
Mr. Wesley J. Smith,
While it may be true that Geron did/does not derive its’ hESC’s using ACT’s non-destruction methods your blanket statement that “ESCs are obtained by destroying nascent human life.” is still incorrect.
Whatever Advanced Cell Technology’s motivation, the fact remains they have developed a process of hESC derivation without destroying the embryo.
Wesley J. Smith Reply:
July 30th, 2010 at 8:07 pm
That won’t be used. And when human cloning rolls around, we will be into creating human life for the purpose of destroying it.
July 30th, 2010 | 9:41 pm
[...] term spinal cord injury patients (see here, here, here, here, here and here). All, as Wesley Smith points out, without the fanfare of the [...]
July 30th, 2010 | 9:45 pm
[...] term spinal cord injury patients (see here, here, here, here, here and here). All, as Wesley Smith points out, without the fanfare of the [...]
July 30th, 2010 | 10:18 pm
D.M. Soboslay, the ACT claim was false. Nearly all if not all of the embryos in their experiment were destroyed. They did not find a way to isolate ESCs without destroying the embryos.
Wesley J. Smith Reply:
July 30th, 2010 at 11:33 pm
bmmg39: After the initial false report, they did, actually.
July 31st, 2010 | 6:15 am
Wesley: Your statement “[t]hat won’t be used” is odd to say the least. Few if any business organizations go through the trouble and expense of developing a new technology without intending to use it, yet you’re able to make a blanket statement that Geron won’t. What they MAY do or WON’T do in the future about “creating human life for the purpose of destroying it” seems to be just so much idle speculation. Are you so committed to the adult stem cell camp that you’ve closed your mind to any other options? It sounds almost like the mindset at the turn of the 20th Century when some folks suggested that we ought to close the Patent Office because just about everything that could be invented had been.
July 31st, 2010 | 6:13 pm
Blastomere transfer is a “gimmick”?
Hahaha, yep, that settles it. gimmick… despite the fact that it works and can be done. Makes sense to me.
Soboslay:
Excellent, excellent posts.
We can obtain ESCs without destroying the embryo. I pointed blastomere transfer out to this blog a long time ago. It speaks of one’s scholarship and knowledge of the issue that such mistakes are continued. It’s interesting to watch those in opposition continue to ignore this reality and wonder why they are not taken seriously where it matters and when it counts.
Wesley J. Smith Reply:
July 31st, 2010 at 6:24 pm
David, we were discussing that approach long before you were ever heard of around here.
August 1st, 2010 | 10:03 am
Soboslay, so every spinal cord injury patient undergoing this treatment must create a cloned child so as not to destroy the embryo? That hardly solves the ethical issue does it? Or is the idea that the left over cloned embryo will merely be frozen forever, but not technically destroyed? That wouldn’t be possible, eventually it would unfreeze and be destroyed.
August 2nd, 2010 | 12:41 am
HW, I think your comments about Wesley not being open to other techinques needs some recent historical perspective. He was one of the guys in the thick of it, talking about other pluripotent alternatives for a couple years when the ESCR/SCNT proponents and their politicians said ESCR/SCNT was THE best chance and those who stood in the way were luddites, religious ideologues etc who would let people’s kids die of diabetes and other diseases. Believe me, it wasn’t fun. They downplayed if not ridiculed pluripotent alternatives. But then one day in November 2007 Wesley posted to SHS that he had some really big game changer news that he couldn’t talk about and that it was embargoed until the morning. It wasn’t hard to guess because Dolly the Sheep Cloner Ian Wilmut had just said he was leaving ESCR/SCNT to go work with the Japanese Scientist Yamanaka who had figured out how to create pluripotent stem cells by direct reprogramming in animals and a leading British stem cell researcher-I think he was from the UK-said he’d heard there was a breakthrough with humans. He was one of the first to announce and comment on the breakthrough that pluripotent stem cells that don’t require cloning/SCNT had been discovered and created by direct reprogramming. James Thomson himself was saying it was probably the end of an era and unless you knew where they came from, you couldn’t tell these pluripotent cells from ones derived from embryos. What a game changer that was. It was like Kobe Bryant knocking down a game winning three pointer in Boston garden. It almost silenced the crowd. All of the sudden, Edwards, Clinton and Obama weren’t saying anything about ESCR/SCNT in their speeches.
You can call Wesley close minded, but you had to be there between 2003 and 2007 and into 2008 to appreciate how untrue your charge is and how he was on the leading edge of discussing these things and commenting on the new technique when it came out. He was promoting other alternatives and he turned out to be right, along with GWB who funded things like this by EO when Congress wouldn’t, and he turned out to be right. There could be ethical pluripotent alternatives to ESCR and there were.
The volume has come WAY down since that day and you’d hardly know iPSCs existed unless you follow this stuff all the time. That’s for obvious reasons just like you don’t hear much protest against the Iraq war now that it’s Obama’s war.
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