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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: Amelia

...not necessarily. Federal funding can be used for lines derived prior to 2001.


101 posted on 02/03/2009 7:30:44 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: Humal
Because of the restrictions, embryonic stem cells have not shown the promise that was hoped...the existing lines are contaminated. So this move by 0bama will open up other lines.

A better approach than President Bush's might have been to keep up with the science and support the techniques (that were developed later) that don't require fetus destruction. By the Administration being so rigid and dogmatic instead of reality-based, more embryos have been killed in private and overseas research.

This is a big winner issue for Obama. The Bush Administration's mishandling of this issue has alienated a lot of Americans. Many wonder why federal funds couldn't be used for research that doesn't destroy any fetus, yet has the potential of saving lives and alleviating suffering.

102 posted on 02/03/2009 7:37:09 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: Hildy

Yes they do


103 posted on 02/03/2009 7:38:54 AM PST by Mo1
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To: Gondring

All of the embryos are destroyed once the stem cells are harvested.


104 posted on 02/03/2009 7:42:49 AM PST by ga medic
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To: ican'tbelieveit
Why does it actually have to act on that coding before you classify it as human?
If genetic coding were sufficient, cancer cells would be human.
105 posted on 02/03/2009 7:44:08 AM PST by dbz77
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To: ohioWfan
The President's ban on the funding of embryonic stem cells is what has led scientists to look for other means of developing stem cells

I am sorry but this is incorrect. The President's ban did not lead scientists to look for alternatives. Alternatives were being researched well before the president got involved.

In my opinion this issue has always had less to do with finding actual cures than with 'researchers' getting their work funded.
106 posted on 02/03/2009 7:50:21 AM PST by dmartin (Not the 'Change' you were 'Hoping' for?)
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To: maryz
Anyone sane has to realize that autochthonous stem cells are the way to go!

Anyone sane and educated realizes that we have progressed best when following multiple lines of research.

E.g., why did we research optical storage, when magnetic showed such promise?

107 posted on 02/03/2009 7:56:37 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: dbz77

So which organ is good enough? I really want people to consider this.

How about not justifying this as acceptable because it is just a clump of cells and admitting that you are willing to experiment on human life and accept the consequences of your behavior.

When it is justified as acceptable because it is just a clump of cells, it speaks volumes in comparison to other justifications for tragedies in human history.


108 posted on 02/03/2009 7:58:20 AM PST by ican'tbelieveit ((Join FreeRepublic's Folding@Home team (Team# 36120), KW:Folding))
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To: STARWISE

If a blastocyst is “a human” and not just “human,” why aren’t those cells being injected into someone else “a human,” too?


109 posted on 02/03/2009 8:00:54 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: DoingTheFrenchMistake
Science like everything else simply moves offshore out of the reach of American Luddites.

It's like the protectionist ostriches who seem to think we can (and should) control everyone else. Leftism under a "conservative" nameplate.

110 posted on 02/03/2009 8:03:50 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: ican'tbelieveit
So which organ is good enough? I really want people to consider this. How about not justifying this as acceptable because it is just a clump of cells and admitting that you are willing to experiment on human life and accept the consequences of your behavior. When it is justified as acceptable because it is just a clump of cells, it speaks volumes in comparison to other justifications for tragedies in human history.
What is the objective test for humanity?
111 posted on 02/03/2009 8:06:46 AM PST by dbz77
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To: Gondring
If a blastocyst is “a human” and not just “human,” why aren’t those cells being injected into someone else “a human,” too?
How can they not be a human?
112 posted on 02/03/2009 8:07:58 AM PST by dbz77
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To: STARWISE
"I like the idea of the American people's representatives expressing their views on an issue like this," Obama told CNN.

IOW, if the public ever turns against this idea in sufficient numbers, O could blame Congress.

113 posted on 02/03/2009 8:13:36 AM PST by Constitutionalist Conservative (Two blogs for the price of none!)
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To: Gondring

“Many wonder why federal funds couldn’t be used for research that doesn’t destroy any fetus, yet has the potential of saving lives and alleviating suffering.”

I also think some of the frustration is a lack of consistency in this policy. GWB put limitations on stem cell research funding, yet there are many other types of research, such as fertility treatments, that still qualify for federal funding. This research routinely destroys embryos as well.

IVF clinics routinely destroy embryos in large numbers. Thousands a day are simply washed down the drain, or frozen indefinately. Yet, we rarely hear of efforts to change policies and procedures used in the assisted reproduction processes.


114 posted on 02/03/2009 8:16:01 AM PST by ga medic
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To: ga medic
All of the embryos are destroyed once the stem cells are harvested.

Nope. Good guess, though.

That's the way it was in the past...but not now. First of all, as was pointed out, once the initial harvesting, there are no more embryos destroyed, but now, the blastocyst is unharmed.

Klimanskaya I, Chung Y, Becker S, Lu SJ, Lanza R. (2006). "Human embryonic stem cell lines derived from single blastomeres". Nature 444 (7118): 481–5. PMID 16929302 doi:10.1038/nature05142

The current attack on embryonic stem cell research is all a sham. It uses problems of the past to fool people into coughing up $, at the cost of compassion for the suffering.

Besides, many, many, many embryos are destroyed anyway (IVF)...it's a shame that no good can come from that loss.

115 posted on 02/03/2009 8:16:26 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: JSteff

They want to use Maruta and assist clients as the same time. It’s the liberal idea of killing two birds with one stone.

Banzai!


116 posted on 02/03/2009 8:16:30 AM PST by Soothesayer (The United States of America Rest in Peace November 4 2008)
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To: sarah p

on stem cells?


117 posted on 02/03/2009 8:17:23 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
GWB put limitations on stem cell research funding

Acutally, GWB opened up federal funding for stem cell research where funding had not existed before, including embryonic stem cell research.

118 posted on 02/03/2009 8:22:55 AM PST by ican'tbelieveit ((Join FreeRepublic's Folding@Home team (Team# 36120), KW:Folding))
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To: Sun

who is experimenting on embryos?


119 posted on 02/03/2009 8:29:07 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: dbz77

Is every drop of blood you shed a separate human?


120 posted on 02/03/2009 8:32:03 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: omega4179

“The maruta must be conserved!”

-Dr Shiro Ishi,
commander of Unit 731


121 posted on 02/03/2009 8:33:18 AM PST by Soothesayer (The United States of America Rest in Peace November 4 2008)
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To: ga medic

Obviously, I am referring to how research could be conducted, not how it is currently done. It’s easier to go offshore than to stop killing embryos, with the way the current restrictions are.


122 posted on 02/03/2009 8:34:19 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
” Many wonder why federal funds couldn't be used for research that doesn't destroy any fetus,”

Wasn't this what adult stem cell research did? They did have a number of embryonic cells that they were using. If I remember correctly, and without looking it up, I believe President Bush's plan said no additional embryonic cells could be developed than what was already had. They could use existing cells, and they did not prove to be as effective as adult stem cells.

I remember that he called in scientists, who gave their view on adult stem cell research vs. embryonic stem cell research. Then, he called in clergy (can't remember if he went outside the Christian faith), and they gave their opinion on the morality issue of when life begins and using embryonic stem cells.

See
http://www.frc.org/get.cfm?i=IS06H01

http://www.frc.org/get.cfm?i=IS07L01

http://www.frc.org/insight/adult-stem-cell-sucess-stories-2008-jan-june

http://www.freerepublic.com/focus/f-news/2176333/posts (Can't access the original source. This may be what they are going to do in my friend who is scheduled for back surgery.)

http://www.sciencedaily.com/releases/2009/01/090128160933.htm

There are more articles, but this gives you an idea of where my views were coming from.

123 posted on 02/03/2009 8:37:28 AM PST by Humal
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To: arealconservativeforachange
Sorry, but John McCain is just on the wrong side. (I'm pro-suffering.)

</sarc>

124 posted on 02/03/2009 8:39:12 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: Humal

It was discovered that the existing embryonic lines were contaminated.


125 posted on 02/03/2009 8:40:26 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: Syncro

LOL!


126 posted on 02/03/2009 8:41:14 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: littlehouse36
This is sad beyond belief.

Yes, potential hope for spinal cord injury victims always brings me down.

127 posted on 02/03/2009 8:42:10 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: nutmeg
Yeah, good thing we got that Pro-Embryonic Stem Cell guy McCain instead of that Pro-Life nut Ron Paul! </sarc>
128 posted on 02/03/2009 8:44:12 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 all for the use of techniques that do not result in the destruction of the embryo. However, if this is the study that I am thinking of, the embryos were actually destroyed in this research, even though the method of extraction was not the cause of this destruction.

I wasn’t clear whether this was just an initial requirement, until the research reached a certain point, or whether the embryos were destroyed because they did not have an alternative for preserving them.

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.

It is my great hope that pluripotent stem cell lines can one day be extracted from embryos without damaging the embryo in any way. I think we are several years away from such a possibility, but scientists should be working hard towards this possibility.


129 posted on 02/03/2009 8:44:36 AM PST by ga medic
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To: Gondring

No.


130 posted on 02/03/2009 8:47:29 AM PST by dbz77
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To: benjibrowder
I hope this falls flat on its ass. The Embryonic Stem Cell Research gets us nowhere.

Do you likewise cheer for more people to get paralyzed, you wonderfully compassionate slug?

131 posted on 02/03/2009 8:48:07 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: ican'tbelieveit

Technically you are right, but there hadn’t been requests for embryonic stem cell research funding prior to GWB’s administration.

He did allow the funding, but limited the reseach to existing lines, which proved infeasible due to extensive contamination of the lines created.


132 posted on 02/03/2009 8:55:19 AM PST by ga medic
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To: dbz77
Presumably when it organizes into organs.

One standard I like is to use the medical profession's own definitions. That way, it's pretty hard for them to deny.

What's the medical definition of death? Something like: no heartbeat and/or lack of measurable brain activity? Well then the inverse could certainly define life: Measurable brain activity and a heartbeat.

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.

(That also handily defeats the "fetus is just another organ" idiocy. Does an organ have its own brain and heart?)

133 posted on 02/03/2009 8:55:21 AM PST by TChris (So many useful idiots...)
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To: dbz77

“It depends on how the cells are organized into tissues and organs.”

No, it doesn’t depend on how the cells are organized. These “clumps of cells” and even single fertilized egg cells fit all of the scientific parameters required to classify something as alive.

If these cells are not alive, and they certainly are not dead, what are they?

Even single-celled organisms, such as bacteria, are alive, and they never organize into tissues and organisms. How can one argue that bacteria are alive, but human embryonic cells are not.

Some are trying to classify these cells as something other than living to suit their own social agendas.


134 posted on 02/03/2009 9:02:15 AM PST by sarah p
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To: Gondring

yes, on stem cells. Scientist have been doing research with embryonic stem cells using animal models, such as rats, for awhile. Using animal cells to study human diseases is the precursor to most human cell research. These studies indicate that adult stem cells show far more promise than embryonic cells to treat diseases.

There is also the larger ethical question of advancing any research that could lead to the large scale dependence on the destruction of human life. The ethical and more practical course should be to provide more funding for adult stem cell research.


135 posted on 02/03/2009 9:13:43 AM PST by sarah p
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To: Gondring
Do you likewise cheer for more people to get paralyzed, you wonderfully compassionate slug?

Thanks for the reminder of one of the reasons why I stopped posting here, Gondring. (Or is that John Edwards out there......if only John Kerry had been elected, think of all the paralyzed folks who would now be walking....sobbing here.....)

Seriously........liberalism under the guise of "compassion" is still liberalism.

Ending human life for the purpose of research when other methods are available and more productive is the opposite of compassion.

If that's your position, then you are the polar opposite of compassionate, and therefore unable to determine that quality in others.

It is the pro-life movement that cares about not only the unborn, but the mothers, the negative effect that ending their lives has on the culture, and therefore the country. It is we who care, not our foes.

Believing that ending life when other options are not only available, but more productive, is not only liberal, but it is senseless.

Embryonic stem cell research is senseless.

136 posted on 02/03/2009 9:16:50 AM PST by ohioWfan (Thank you PRESIDENT BUSH!!!)
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To: ga medic

There were requests for funding. And limitations on funding through congress, etc.


137 posted on 02/03/2009 9:23:18 AM PST by ican'tbelieveit ((Join FreeRepublic's Folding@Home team (Team# 36120), KW:Folding))
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To: dbz77

“If genetic coding were sufficient, cancer cells would be human.”

If they come from a human, cancer cells ARE both human and living.


138 posted on 02/03/2009 9:25:20 AM PST by sarah p
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To: dmartin
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.

As a result, it has been discovered that adult stem cells are more productive, and there is no need to end one human life to save another. I am correct. The President's ban on funding indeed led to expansion on alternatives.

So, of course, yes, it's about funding. But denying funding to death has led to enormous success in other areas of research.

The ethical answer in medicine will always be the most successful in the long run. The ethical answer is to err on the side of life.

139 posted on 02/03/2009 9:29:12 AM PST by ohioWfan (Thank you PRESIDENT BUSH!!!)
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To: Gondring

“Yes, potential hope for spinal cord injury victims always brings me down.”

Why don’t you give them hope and donate some of your own spinal nerves? Or why don’t we remove them from criminals in prison? Or how about from poor people that are a “burden” on society?

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


140 posted on 02/03/2009 9:34:35 AM PST by sarah p
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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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