Free Republic
Browse · Search
News/Activism
Topics · Post Article

Skip to comments.

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
Navigation: use the links below to view more comments.
first previous 1-20 ... 201-220221-240241-260 ... 321-329 next last
To: ga medic

Pres. Bush was very specific about this research, which was already in progress when he came into office.

His policy was in sync with the high regard for the sanctity of life conservatives hold, and was especially emphatic in discouraging the creation of new life specifically for research, therefore preserving the dignity of life (human beings like we once were) and blunting the opportunities for trafficking in human life and human elements, (a tragic reality which now sadly comes onto our radar screen with the leftists in charge.)

~~~~~

“President Bush’s Criteria

On August 9th, 2001, President George W. Bush announced that federal funds may be awarded for research using human embryonic stem cells if the following criteria are met:

* The derivation process (which begins with the destruction of the embryo) was initiated prior to 9:00 P.M. EDT on August 9, 2001.

* The stem cells must have been derived from an embryo that was created for reproductive purposes and was no longer needed.

* Informed consent must have been obtained for the donation of the embryo and that donation must not have involved financial inducements.”

http://stemcells.nih.gov/policy/


221 posted on 02/03/2009 3:23:39 PM PST by STARWISE ( They (LIBS-STILL) think of this WOT as Bush's war, not America's war- Richard Miniter))
[ Post Reply | Private Reply | To 217 | View Replies]

To: Amelia

You’re exactly right.


222 posted on 02/03/2009 3:57:03 PM PST by Gondring (Paul Revere would have been flamed as a naysayer troll and told to go back to Boston.)
[ Post Reply | Private Reply | To 166 | View Replies]

To: STARWISE

And this research meets President Bush’s criteria, even without use of Federal funding.


223 posted on 02/03/2009 3:58:17 PM PST by Gondring (Paul Revere would have been flamed as a naysayer troll and told to go back to Boston.)
[ Post Reply | Private Reply | To 221 | View Replies]

To: Gondring

How so?


224 posted on 02/03/2009 4:09:31 PM PST by STARWISE ( They (LIBS-STILL) think of this WOT as Bush's war, not America's war- Richard Miniter))
[ Post Reply | Private Reply | To 223 | View Replies]

To: Gondring

I did not make that up. Any who works with cell lines knows that contamination is a constant problem. There are techniques to reduce contamination, but there are not any full proof methods to prevent it.

“Each manufacturing run of GRNOPC1 is subjected to standardized quality control testing to ensure viability, sterility and appropriate cellular composition before release for clinical use. “

They do quality control because there is ALWAYS the potential for cell lines to become contaminated. Again, anyone who works with cell lines knows this.

“The existing master cell bank could potentially supply sufficient starting material for GRNOPC1 to commercially supply the U.S. acute spinal cord injury market for more than 20 years.”

This sounds like some sort of PR release from the company. Their claim that they have a 20 year supply is not a scientifically proven fact, it is just a prediction. Notice how they use the words “could potentially supply.”

Remember, this is from a biotech company that wants to sell their product. This does not include any of the original data that was used to make this claim.

Your accusation that “I just made that up” is wrong.


225 posted on 02/03/2009 4:48:35 PM PST by sarah p
[ Post Reply | Private Reply | To 218 | View Replies]

To: Gondring

Some call it God, others call it natural selection. Whatever you call it, a spontaneous death by natural causes is NOT the same as a death purposefully caused by another human being.


226 posted on 02/03/2009 4:56:07 PM PST by sarah p
[ Post Reply | Private Reply | To 219 | View Replies]

To: sarah p
Thanks for that response, sarah p.

It seems that there should be a course required by all science majors and pre-med, and med students that forced them to think about the deep ethical questions that they might be faced to deal with in their careers.

It is pretty unlikely that any liberal academic institution (are there any that are not, other than a handful of private Christian schools?), would even allow them to think for themselves, but it would be a valuable addition to their education to give serious thought to what they may be doing.

Then again, there is so much mind control from liberals in academia, that who knows if they would even graduate if they bucked the system and concluded that embryos are living human beings.

Part of the problem we are dealing with is that liberalism is so pervasive in our culture that we are fighting a seemingly impossible uphill battle to keep the minds of our young people free from the contamination of leftist thought.

227 posted on 02/03/2009 5:15:16 PM PST by ohioWfan (Thank you PRESIDENT BUSH!!!)
[ Post Reply | Private Reply | To 210 | View Replies]

To: sarah p
Sort of like saying that dying of cancer or a heart attack is the same thing as being murdered.

No comparison can be made in a rational mind.....

228 posted on 02/03/2009 5:16:35 PM PST by ohioWfan (Thank you PRESIDENT BUSH!!!)
[ Post Reply | Private Reply | To 226 | View Replies]

To: pillut48
God is in control. God is in control.
In control of what ?
229 posted on 02/03/2009 5:16:45 PM PST by dbz77
[ Post Reply | Private Reply | To 189 | View Replies]

To: ohioWfan
The problem with that 'pluripotent' cell is that it is a human embryo that could be a scientist, or physician, or mathematician, or musician, or philanthropist, or just a regular old good guy........
Or a rapist, or a murderer, or a war criminal.

It is best to avoid these types of arguments altogether.
230 posted on 02/03/2009 5:18:18 PM PST by dbz77
[ Post Reply | Private Reply | To 191 | View Replies]

To: sarah p
Does that mean that a living embryo that has not been in a uterus that is killed is not an abortion?
Of course not.

An abortion is a termination of a pregnancy. An embryo that has never been attached to a uterus, by definition, was not involved in a pregnancy.

Someone who was shot to death obviously was not killed in a plane crash. An in vitro conceived embryo who, for some reason, does not even attach to the uterus certainly was not killed by abortion.
231 posted on 02/03/2009 5:21:35 PM PST by dbz77
[ Post Reply | Private Reply | To 213 | View Replies]

To: sarah p
I don’t believe that the physical location of the living embryo defines whether it can be called an abortion when it is killed.
Of course it does, just as physical location determines whether or not a death is caused by a plane crash.
232 posted on 02/03/2009 5:23:15 PM PST by dbz77
[ Post Reply | Private Reply | To 213 | View Replies]

To: dbz77
No.

It's a human being whose life is being ended.

If we are afraid of the discussion, then we are the lesser for it. It may be easier to say, "Don't talk about that!" But that doesn't make it the right thing to do.

50 million babies have been killed by abortions, and who knows how many more by destroying embryos or tearing them apart for study.

Many of those babies would have been my children's peers, and they never had the chance to draw their first breath. Many fine people have been denied life because the more powerful person chose to end theirs. Some may have ended up in prison, but is their life any less valuable in the sight of God?

We NEED this discussion, dbz77. We need it badly.

233 posted on 02/03/2009 5:25:08 PM PST by ohioWfan (Thank you PRESIDENT BUSH!!!)
[ Post Reply | Private Reply | To 230 | View Replies]

To: dbz77
Are you any less murdered if it happens in your kitchen or in a ravine?

If another human being is killing you, what difference does the "physical location" make?

It's the same mode of death......your life has been ended by someone else's hand.

234 posted on 02/03/2009 5:47:54 PM PST by ohioWfan (Thank you PRESIDENT BUSH!!!)
[ Post Reply | Private Reply | To 232 | View Replies]

To: ohioWfan

I wouldn’t really call it liberal mind control in academia, it’s more like peer pressure.

I know many liberal educators very well and there is not a mind control conspiracy or anything like that. Many people in academia honestly believe that they know better than people who do not have advanced degrees. They push their liberal ideas because they think they are smarter than others, so they must be right.


235 posted on 02/03/2009 6:00:55 PM PST by sarah p
[ Post Reply | Private Reply | To 227 | View Replies]

To: ohioWfan; sarah p; wagglebee; All
"Since Roe, at least 50 million abortions (equal to the combined populations of 25 states) have been performed........"

(add another million for 2008)

Tragic ... devastating, horrible savagery and untold loss to and for humanity.


236 posted on 02/03/2009 6:04:33 PM PST by STARWISE ( They (LIBS-STILL) think of this WOT as Bush's war, not America's war- Richard Miniter))
[ Post Reply | Private Reply | To 233 | View Replies]

To: sarah p
I agree with you about the motivation of most leftist educators. It's not that they're deliberately trying to brainwash their students (some obviously are), but it's that they are so stinking arrogant and narrow minded that they consider any opinion other than their own to be utterly ridiculous.

But the result is the same with either kind of professor. The kids come out brainwashed without a clue as to how to make ethical choices in any field.

(In case you can't tell, I have enough 'up close and personal' experience with academia to be nauseated by it).

237 posted on 02/03/2009 6:05:59 PM PST by ohioWfan (Thank you PRESIDENT BUSH!!!)
[ Post Reply | Private Reply | To 235 | View Replies]

To: dbz77

>> Or a rapist, or a murderer, or a war criminal.

It doesn’t matter what they might become. It matters what they are. A human embryo is not something to be cannibalized.

Do you know what they call animals that feed on the flesh of their own species?


238 posted on 02/03/2009 6:17:33 PM PST by Gene Eric
[ Post Reply | Private Reply | To 230 | View Replies]

To: dbz77

It seems as though you missed the point of my comment.

I wrote. “Well I guess that depends on what your definition of what an aborted baby is.”

There are multiple accepted definitions for the word abortion. Those who choose to acknowledge that an embryo is a living human being believe that it does not matter where the life is aborted. The location of the embryo is inconsequential to them because they want to protect that life.

Those who choose to ignore the fact that an embryo is a living human being would much rather nitpick at their definition of abortion and try to make the location of the embryo when it is killed seem important. This is an attempt to divert attention away from the fact that these embryos are being killed. This is done to marginalize the life of the embryos so that they can rationalize killing them.


239 posted on 02/03/2009 6:20:02 PM PST by sarah p
[ Post Reply | Private Reply | To 232 | View Replies]

To: ohioWfan

“they are so stinking arrogant and narrow minded that they consider any opinion other than their own to be utterly ridiculous.”

You hit the nail right on the head!

However, they are not all bad. There is an overall sense that they are working toward the common good. Many go into research to help others and cure diseases.


240 posted on 02/03/2009 6:36:02 PM PST by sarah p
[ Post Reply | Private Reply | To 237 | View Replies]


Navigation: use the links below to view more comments.
first previous 1-20 ... 201-220221-240241-260 ... 321-329 next last

Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.

Free Republic
Browse · Search
News/Activism
Topics · Post Article

FreeRepublic, LLC, PO BOX 9771, FRESNO, CA 93794
FreeRepublic.com is powered by software copyright 2000-2008 John Robinson