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FDA approves first human embryonic stem cell safety trial (3 days after Pres. Bush left)
Scientific American ^ | 1-23-09 | Jordan Lite

Posted on 02/02/2009 7:07:22 PM PST by STARWISE

Federal regulators have green-lighted the first trial of an embryonic stem-cell treatment in humans.

The U.S. Food and Drug Administration (FDA) gave the go-ahead for Geron Corporation to start a phase I safety trial of its therapy GRNOPC1 for spinal cord injuries, the Menlo Park, Calif.–based company announced today.

It first sought permission for the trial four years ago and spent much of the last year trying to satisfy the FDA’s concerns about it.

"This marks the beginning of what is potentially a new chapter in medical therapeutics—one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells,” Thomas Okarma, Geron's president and CEO, said in a statement today.

The trial will involve up to 10 patients and will test whether it is safe to inject nerve cells from embryos into the site of their injuries, according to Geron. A study published in 2005 in the Journal of Neuroscience found that giving rats the injections seven days after a spinal cord injury improved their motor function.

Wise Young, director of The W. M. Keck Center for Collaborative Neuroscience at Rutgers University, hailed the FDA’s decision, but says his expectations are tempered.

“It’s a big deal—it’s a long time in coming. There’s a lot of hope riding on this,” Young tells ScientificAmerican.com. But he cautions that people should not expect "a miraculous result" from this initial trial.

"I do believe cellular therapy will have a beneficial effect," he says, "but it’s very important to understand that we’re just starting. We have a long road to go.”

Geron and FDA officials told The Wall Street Journal that it was a coincidence that the announcement came just three days after George Bush left the White House. Bush restricted federal funding of embryonic stem cell research.

"The FDA looks to the science on these types of issues, and we approve [such applications] based on a showing of safety," FDA spokesperson Karen Riley told the Journal. “Political considerations have no role in this process."

Pres. Obama said during his campaign that he would lift the ban on federal funding of research on embryonic stem-cell lines produced after August 9, 2001. But he told CNN on January 18 that he may ask Congress to undo it.

Lawmakers passed legislation three times during the Bush administration that would have erased the limit and allowed research on stem cells from embryos at fertility clinics (with donors' consent) that would otherwise be discarded; Bush vetoed them all.

"I like the idea of the American people's representatives expressing their views on an issue like this," Obama told CNN.

That may not be a bad thing, Young says. “If he were to reverse this on his own, it takes Congress off the hook.

It’s much more important that Congress makes sure this doesn’t happen again,” he says. “What is worrisome is that if Obama did just reverse the rule, stem cells would be a political football in Congress to trade for something else.

It’s really important from the viewpoint of the advocacy community that legislation is passed so other presidents don’t come in and say, ‘I will forbid this.’”


TOPICS: Breaking News; Constitution/Conservatism; Front Page News; Government; Politics/Elections
KEYWORDS: abortion; abovemypaygrade; ameirca2point0; bho44; bhoabortion; bhoethics; cloning; cultureofdeath; culturewar; deathindustry; embryonicstemcells; embryos; fda; firsthundreddays; geneticcannibalism; ghouls; graverobbers; infanticide; junkscience; notbreakingnews; obama; obamatruthfile; prolife; pseudoscience; slaughter; suckers
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To: gondramB; STARWISE; Admin Moderator; Amelia; Sun; jveritas; swmobuffalo; Intolerant in NJ; ...
I am thoroughly disgusted with the knee-jerking that goes on here these days (just some folks...I'm certainly not meaning everyone I pinged!). I am including a Moderator ping since some folks like to hit the abuse button when they can't support their position, and I just want to be proactive in making it understood why I am posting my viewpoints and why they are the way they are. Let's look at a few items...

I'm saddened that FR has become proudly anti-science and proudly knee-jerk, it seems. It truly hurts our cause to display such irrationality. I hope that some people will stop and think and get informed instead of just screaming.

(Of course, some folks get it...e.g., Intolerant in NJ at #15 :-)

141 posted on 02/03/2009 9:44:03 AM PST by Gondring (Paul Revere would have been flamed as a naysayer troll and told to go back to Boston.)
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To: ga medic
I was very excited about this research, because I don’t believe those who claim that there are no benefits to be derived from pluripotent stem cells. I believe they have tremendous potential for all kinds of cures, but there is much research to be done.

Agreed.

142 posted on 02/03/2009 9:44:50 AM PST by Gondring (Paul Revere would have been flamed as a naysayer troll and told to go back to Boston.)
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To: sarah p
Why don’t you give them hope and donate some of your own spinal nerves?

Because I'm not an ignorant fool, so I realize that my spinal nerves don't have as much potential to help as this, and I also realize that there's no need for anyone to be killed to allow this research to proceed.

Who are we to classify which human lives are ok to sacrifice?

Please tell me, since you seem so intent on sacrificing someone even when there's no need.

143 posted on 02/03/2009 9:47:24 AM PST by Gondring (Paul Revere would have been flamed as a naysayer troll and told to go back to Boston.)
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To: Gondring
Please tell me, since you seem so intent on sacrificing someone even when there's no need. An excellent argument against embryonic stem cell research, Gondring. Bravo!

There is no need to sacrifice human life when other avenues are not only available, but more productive.

144 posted on 02/03/2009 9:50:45 AM PST by ohioWfan (Thank you PRESIDENT BUSH!!!)
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http://www.weeklystandard.com/Content/Public/Articles/000/000/006/136wxrww.asp

WE HAVE HEARD IT STATED SO OFTEN it has become a media mantra: Embryonic stem cells (ESCs) offer the greatest hope for cures; adult and umbilical cord blood stem cells have far less potential; the Bush administration's embryonic stem cell funding restrictions have caused America to fall behind in the great international race to develop effective ESC treatments.

Baloney, baloney, and pure baloney: The problems with harnessing embryonic stem cells as treatments appear to be growing, not shrinking.

By contrast, the umbilical cord blood and adult stem-cell breakthroughs keep on coming. Human trials are ongoing for heart disease, spinal cord injury, eye afflictions, and many other diseases. And here's a bit of potentially very big news: A just-published peer-reviewed study (Cytotherapy, Vol. 7. No. 4 (2005), 368-373) reports that scientists have used umbilical cord blood stem cells to restore feeling and mobility to a spinal cord injury patient.

http://www.lifesitenews.com/ldn/2006/aug/06081804.html

UK Researcher: Cord Blood Real Potential for Cures, Not Embryonic Stem Cells -

There is another motive for this move by Obama.Either Eugenics, more abortions, or more ridicule to Bush.

145 posted on 02/03/2009 10:00:45 AM PST by OafOfOffice
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To: ohioWfan
You had requested I stop pinging/posting to you and I have complied. I had requested the same courtesy.

I take it that since you are replying to me, you will not mind me replying to you and pointing out that you're full of ___.

Whether they stick these cells into these peoples' backs or not, there will not be a single difference in the number of embryos destroyed.

I don't believe you are pro-life or compassionate. Based on your repeated ignoring of reality, evidence, and logic, I believe you are pro-disruption and anti-compassion.

But that's simply my conclusion based on your actions. You might be a wonderful person just doing a fine acting job.

146 posted on 02/03/2009 10:03:22 AM PST by Gondring (Paul Revere would have been flamed as a naysayer troll and told to go back to Boston.)
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To: Gondring

I am not intent on anyone being sacrificed. If you have read my posts, you would see that I am for advancement of research that does not depend on the destruction of human life.

Also, how do you know that your spinal nerves don’t have potential to help? Of course I was being sarcastic in asking that.

My point was that there are ethical lines to what type of research should be done. There is no public outcry for research that would require the destruction of already born humans because it is obviously wrong.

If we advance embryonic stem cell research, it is only going to increase the demand for more embryos. There are also many more problems that need to be resolved using embryonic cells with rejection from the patients immune system. This problem does not exist when adult stem cell from the patient are used.

It makes more sense ethically, scientifically and financially to develop adult stem cells instead of embryonic.


147 posted on 02/03/2009 10:03:39 AM PST by sarah p
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To: ohioWfan
An excellent argument against embryonic stem cell research, Gondring. Bravo!

Only to the ignorant or dishonest.

But let's hear you explain how this research that is in the article and was proceeding under the Bush Administration was going to result in a single death.

148 posted on 02/03/2009 10:05:40 AM PST by Gondring (Paul Revere would have been flamed as a naysayer troll and told to go back to Boston.)
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To: Gondring

I wasn’t trying to be anti-science at all, I was more concerned with the legalities... with which I was somewhat unclear.

Short point: I’m tired of certain people or groups being treated differently because they happen to line up with some political line. (Why did that guy who had the FBI marked monies in his freezer NOT go to jail? How did he get re-elected? Why did nothing come of the multiple federal investigations of ACORN?)

Some animals are more equal than others. [/cynic]


149 posted on 02/03/2009 10:07:28 AM PST by OneWingedShark (Q: Why am I here? A: To do Justly, to love mercy, and to walk humbly with my God.)
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To: sarah p
If we advance embryonic stem cell research, it is only going to increase the demand for more embryos.

Oh? Support this claim, please.

How does that in with the research that is the topic of this thread?

150 posted on 02/03/2009 10:07:32 AM PST by Gondring (Paul Revere would have been flamed as a naysayer troll and told to go back to Boston.)
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To: Gondring; FlingWingFlyer; ohioWfan; Humal; sarah p; Marysecretary; wagglebee; nutmeg; Gene Eric; ...

Am I off base with these speculations ?

###

When does the Chicago Board of Trade open the FCX (Fetal Cell Exchange) window for trading?

When does subtle solicitation (for remuneration) targeting women for hired pregnancies begin?

With the Dims running Congress, I can only imagine the
perverse commercial empires that could be built in the bio-science community.

Planned Parenthood = harvester of choice?


151 posted on 02/03/2009 10:08:49 AM PST by STARWISE ( They (LIBS-STILL) think of this WOT as Bush's war, not America's war- Richard Miniter))
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To: OneWingedShark; jan in Colorado
I'm right with you!

Some animals are more equal than others.

We have our little Napoleon in office now. :-(

One of the reasons things are unequal, though, is that the right has allowed faux conservatives to take over, as they put their nanny-state big government ideas in place, pushing voters over to the Dem side.

While many FReepers complain about the MSM, I don't see many of them founding good, counterbalancing newspapers like I did. If we knock down the institutions that can investigate both sides, we are left with nothing. When we alienate the electorate, we are left with nothing.

It might have felt good to have GWB make dogmatic, idiotic proclamations, but it didn't do the long-term goals any good.

And I am sick and tired of keeping quiet on this. If people want to shoot the messenger, fine, and if they want to ignore the message, fine, but they can't blame me for not saying anything. See my tagline. :-)

152 posted on 02/03/2009 10:14:21 AM PST by Gondring (Paul Revere would have been flamed as a naysayer troll and told to go back to Boston.)
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To: sarah p

So why should it matter what happens to these cells?


153 posted on 02/03/2009 10:14:37 AM PST by dbz77
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To: All
Obama Lied About Vote Against Live-Birth Abortion Ban, Media Mum

By Warner Todd Huston
August 13, 2008 -

Jill Stanek has done yeoman's work (MUST read)on uncovering the fact that Barack Obama and his surrogates have been outright lying about Obama's constant votes against the Live-Birth abortion bills when he was in office in the State legislature.

His claims have been a staple of Old Media reports from the beginning, but now that Stanek has revealed the truth we will have to see if the Old Media corrects the record or if they suddenly just go mum on the subject like they have so far.

The Born-Alive Infants Protection Act (BAIPA) both in the Illinois and Federal legislatures was meant to make illegal death by neglect of born but unwanted infants.

These bills were opposed by the bulk of the Democrat Party because of the fact that the original bills could have been construed to say that a pre-birth fetus was a "person" that was protected by law. So, the bill in Congress was altered to address that concern by adding a "neutrality clause" that made it clear that the bill would not protect a fetus in utero.

As Obama continues to tell the tale, as a State Senator he said he voted against the Illinois bill because the Federal "neutrality clause" was not included and that therefore he could not support the Illinois bill.

Turns out he is not telling the truth about this fact. Even worse, he knows better because he was part of the legislative committee that added that very "neutrality clause" to the very bill he voted against in 2003.

As Stanek found, Obama not only was part of that committee adding the Federal "neutrality clause" to the Illinois bill, he was the chairman of that committee.

The documents prove that in March 2003, state Senator Obama, then the chairman of the IL state Senate Health and Human Services Committee, presided over a committee meeting in which the "neutrality clause" (copied verbatim from the federal bill) was added to the state BAIPA, with Obama voting in support of adding the revision. Yet, immediately afterwards, Obama led the committee Democrats in voting against the amended bill, and it was killed, 6-4.

It strains credulity to believe that Obama was unaware that the "neutrality clause" was added to the bill if he was the chairman of the committee that put it in there, doesn't it?

So we are forced to realize that Obama knows the truth but is trying to rewrite history and with the willing accomplices in the Old Media he has succeeded in doing so thus far.

(Rest at link)

~~~

Obama has proven his twisted bona fides on this issue.

154 posted on 02/03/2009 10:16:40 AM PST by STARWISE ( They (LIBS-STILL) think of this WOT as Bush's war, not America's war- Richard Miniter))
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To: sarah p
If they come from a human, cancer cells ARE both human and living.
Does this mean that they deserve legal protections?
155 posted on 02/03/2009 10:17:11 AM PST by dbz77
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To: Gondring

It is simple, when more embryonic research is being conducted, then more cells are required to do the research.

Existing cell lines will eventually become contaminated and new ones will have to be created. Contamination is almost impossible to prevent over time. Also, human cell lines are not immortal. After a certain number of cell divisions they die off cease to divide.

So, it is obvious that an increased demand for embryonic stem cells would result in an increased demand for embryos.


156 posted on 02/03/2009 10:18:33 AM PST by sarah p
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To: TChris
I understand that this doesn't match the Catholic view, but it would certainly be a significant improvement if the legal definition of a protected human life was the presence of a heartbeat and measurable brain activity.
How is death defined by the Roman Catholic Church?
157 posted on 02/03/2009 10:18:41 AM PST by dbz77
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To: ohioWfan
As has been previously stated, the lack of funding for embryonic research, so wisely enstated by President Bush, led to a more vigorous research in areas where funding was available......i.e. adult stem cells.

I am correct. The President's ban on funding indeed led to expansion on alternatives.


I am sorry but you are still incorrect. Adult stem cell research was taking place well ahead of the election of President Bush and his ban was limited in scope.

From the WSJ - 'Recall what the President's August 2001 decision actually did. It allowed federal funding for research on existing stem-cell lines where, he said, "the life and death decision has already been made." But it forbade funding for research into new lines, which entailed both the creation and destruction of human embryos.'

While the former President did take the right stand on this issue your suggestion that advances in adult stem cell research was a result of his action is naive.

Your reply to me began with 'As has been previously stated'. Do you have a source or is this just conjecture?
158 posted on 02/03/2009 10:18:43 AM PST by dmartin (Not the 'Change' you were 'Hoping' for?)
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To: All
This article by a Hollywood actor (Ambassador Soval on StarTrek) is well worth your time to read:

Gary Graham - Flashpoint! A Woman’s Right To Choose


159 posted on 02/03/2009 10:23:41 AM PST by STARWISE ( They (LIBS-STILL) think of this WOT as Bush's war, not America's war- Richard Miniter))
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To: ohioWfan
Ending human life for the purpose of research when other methods are available and more productive is the opposite of compassion....Embryonic stem cell research is senseless.

The biggest source of embryos for research right now is not abortions, as some seem to believe, but the in-vitro fertilization industry. It is not unusual for a couple to have many more embryos than they could possibly use created, only to be left in storage indefinitely or destroyed (or used for research) when that couple has completed their family.

There's an argument to be made that using "leftover" embryos for research is more compassionate than simply destroying them, which is the other most-likely option for couples who don't want any more children, and don't want unknown genetic full-siblings of their children out there either.

Perhaps the United States should enact regulations such as those in Britain that limit the number of embryos a couple can have created at one time.

160 posted on 02/03/2009 10:29:14 AM PST by Amelia
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