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First Human Embryonic Stem Cell Study Approved
dogmatixpsych writes "The FDA recently approved a privately funded study where human embryonic stem cells will be transplanted into subjects with complete spinal cord injuries. All trials will be paid for and conducted by researchers working for Geron Corporation. The stem cells come from the existing lines Pres. Bush approved federal funding for in August 2001. With Barack Obama now president, many scientists believe federal funding will soon become available for embryonic stem cell research on new cell lines, resulting in additional similar studies."
Would stem cell therapy be considered drug therapy? I wonder why the FDA provides approval? Is that the only government agency that enforces this type of research? Me thinks it's great that this "work toward curing disease such as Alzheimer's, Parkinson's and diabetes." is finally getting the approval it deserves.
Namaste
Gotta love the FDA. How long has this technology been around before they finally approved the first human tests of it? Did you know that if current FDA regulations had been in place at the time, neither penicillin nor aspirin would have ever been approved for human use?
Liberty in your lifetime
What exactly is BS in what you quoted? Are you disputing the well-known fact that Bush disallowed funding for new stem cell lines beyond those already established? Or are you disputing the claim that many scientists believe that with the new administration that this will be changed? You're going to have a hard time claiming either as BS.
Bush disallowed GOVERNMENT funding of new cell lines, not private funding. If embryonic stem cells were the miracle cure that people have been claiming, you'd think there'd be plenty of private money for it.
"As God is my witness, I thought turkeys could fly." A. Carlson
"Thanks Bush for making it so life-saving treatment research got delayed so much. You stupid fuck."
Fuck Yeah! Because we KNOW it will work, and we KNOW that the existing lines are useless, and we KNOW that the only thing stopping the miracle cures was lack of Federal funding, and we KNOW there won't be side affects, and we KNOW that adult stem cell research will amount to nothing.
"As God is my witness, I thought turkeys could fly." A. Carlson
At least we can safely say that Democrats have no problem with corporate welfare either. Yep, all of these embryonic stem cells are miracle cures, but, god forbid, every biotech company feels the need to pony up to Washington so Obama can pay for the research.
Right and like 10 TRILLION in bailouts thanks to REPUBLICAN screwups isn't corporate welfare? At least R&D funding has a decent chance to make our lives better. The bailouts are just going to office redecoration, golf trips, spa trips and fat bonuses.
"Is there a way to stop with the political jabs and bullshit that has been floating around /. for the past few days? It's annoying."
You ARE aware this is Slashdot, right?
"As God is my witness, I thought turkeys could fly." A. Carlson
Nice, how the wording got changed so that it says the opposite of what is conveyed by the CNN article!
Slashdot article says:
The source article actually states:
And thus:
As someone who works in biological research I sort of agree with you. Not that we shouldn't be funding scientific research, but no one should be able to patent research done with public money. I like the NIH rule that any federally funded research must be published in an open access journal. I would argue for another rule, that any patents from federally funded research must be licensed freely, if granted at all.
Give me Classic Slashdot or give me death!
No one is forcing anyone to stop researching promising treatments based on adult stem cells. Adult stem cells are good at some things, and they have produced successful treatments. Since we've produced successful treatments with adult stem cells, it stands to reason that we can also produce successful treatments with embryonic stem cells. It would be wrong of us to ignore those treatments and allow people to suffer unnecessarily.
Let me also mention that ALL stem cell research requires the destruction of life. A stem cell, whether embryonic or adult, is alive.
Give me Classic Slashdot or give me death!
The REPUBLICANS weren't behind the "affordable housing mission". Democrats blocked regulation in 2004, attacking the regulator, and defeated the Federal Housing Enterprise Regulatory Reform Act of 2005, cosponsored by John McCain. Democrats like Barney Frank cried racism whenever the republicans suggested regulating Fannie Mae and Freddie Mac, and had control of the house financial services committee which oversees the GSEs.
"I worry, frankly, that there's a tension here. The more people, in my judgment, exaggerate a
threat of safety and soundness, the more people conjure up the possibility of serious financial losses to the Treasury, which I do not see. I think we see entities that are fundamentally sound financially and withstand some of the disastrous scenarios. And even if there were a problem, the Federal Government doesn't bail them out . But the more pressure there is there, then the less I think we see in terms of affordable housing."
Rep. Barney Frank (D., Mass.)
House Financial Services Committee hearing
Sept. 10, 2003
"I think this is a case where Fannie and Freddie are fundamentally sound, that they are not in danger of going under. They're not the best investments these days from the long- term standpoint going back. I think they are in good shape going forward. They're in a housing market. I do think their prospects going forward are very solid. And in fact, we're going to do some things that are going to improve them."
Rep. Barney Frank (D., Mass.)
July 14, 2008
"I join as a cosponsor of the Federal Housing Enterprise Regulatory Reform Act of 2005, S. 190, to underscore my support for quick passage of GSE regulatory reform legislation. If Congress does not act, American taxpayers will continue to be exposed to the enormous risk that Fannie Mae and Freddie Mac pose to the housing market, the overall financial system, and the economy as a whole.
I urge my colleagues to support swift action on this GSE reform legislation."
John McCain
May 26, 2006
Here are some additional quotes from the Fannie/Freddie Fraud Investigation in 2004
BAKER (R-LA): It is indeed a very troubling report, but it is a report of extraordinary importance not only to those who wish to own a home, but as to the taxpayers of this country who would pay the cost of the clean up of an enterprise failure.
WATERS (D-CA): Through nearly a dozen hearings where, frankly, we were trying to fix something that wasn't broke, Mr. Chairman, we do not have a crisis at Freddie Mac, and particularly at Fannie Mae, under the outstanding leadership of Mr. Frank Raines.
MEEKS (D-NY): As well as the fact that I'm just pissed off at OFHEO, because if it wasn't for you, I don't think that we'd be here in the first place, and now the problem that we have and that we're faced with is: maybe some individuals who wanted to do away with GSEs in the first place, you've given them an excuse to try to have this forum so that we can talk about it and maybe change the, uh, the direction and the mission of what the GSEs had, which they've done a tremendous job. There's been nothing that was indicated that's wrong, you know, with Fannie Mae! Freddie Mac has come up on its own. And the question that then presents is the competence that -- that -- that -- that your agency uh, uh, with reference to, uh, uh, deciding and regulating these GSEs. Uh, and so, uh, I wish I could sit here and say that I'm not upset with you, but I am very upset because, you know, what you do is give -- you know, maybe giving any reason to, as Mr. Gonzales said, to give someone a heart surgery when they really don't need it.
ROYCE (R-CA): In addition to our important oversight role in this committee, I hope that we will move swiftly to create a new regulatory structure for Fannie Mae, for Freddie Mac, and the federal home loan banks.
CLAY (D-MO): This hea
You don't make the poor richer by making the rich poorer. - Winston Churchill
There are over 400,000 frozen embryos stored in IVF clinics around America that won't be used for pregnancies. Some of them won't be released by the people whose gametes were used to create them, some won't be in a condition usable for science. But there's a lot that could be used for science. They should be, immediately. Actual people with actual diseases are already waiting for the therapies that research will bring, and the line forming behind them lines up forever into the future.
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make install -not war
Why, Obama didn't do anything specific on this. The ban on stem cell research was always dealing with public finds. This article, even in the summery, says that it is being privately funded.
Also, the timing is just too close to Obama's term to be something he has done. The FDA requires some pretty stringent studies and tests before it will allow something to be tested on humans. The request to the FDA for approval for the trials/stufy was probably filed months ago with tests and stuff being done years before that. It's been less then a week since Obama took office and I doubt that is enough time to submit, review, qualify and approve something with the FDA.
If you need to cheer something, cheer private industry that didn't sit around waiting for the government to hand them money to get what they wanted to do done. Hurray for capitalism and private charity.
To put it simply, not all stem cells are created equal. It comes down to potency. By the time a baby is born, stem cells have done a lot of differentiating. They can only create a limited number of tissues. Still useful, but not as useful as early embryonic stem cells. For a quick description of the varying utility of stem cells, try http://en.wikipedia.org/wiki/Stem_cell#Potency_definitions
The world is made by those who show up for the job.
I'd mod you if I had the points, but this will have to do. I have found it hilarious how many people blame Bush for the problems with our economy (blame him for the mistakes in Iraq, that's legit) when in fact the Democrats, going all the way back to Clinton, are the ones who have put us in this mess.
I will blame the Republican majority in the House and Senate in the 90's and early this decade for not doing something about it, although admittedly they did try a few times to fix it (McCain among others). However, apparently they didn't try hard enough. People talk of wanting Bush to get tried for war crimes, but in my opinion it's people like Barnie Frank who should be impeached or recalled for willful disregard when it comes to oversight of the housing market, chiefly as it concerns Fannie and Freddie.
It has been made crystal clear that the stimulus package, while having saved the credit industry from collapse, did little good other than to keep the majority of major banks from folding. Lending has not increased but instead continues to retract, and there is no evidence that supports the big three auto makers avoiding collapse as well (other than possibly Ford, assuming their sales recover). The handling of the economy and in particular spending has been an absolute joke over the past 4 years, and while people would love nothing better than to blame Bush, who submits yearly budgets, it is Congress, who approves the budget, who should really be at the forefront of blame. Republicans lost their mandate due to the handling of the war in Iraq. Unfortunately, most voters are too dumb to realize that the other party, the Democrats, were as clueless on the housing and credit crisis as the Republicans were on fighting a lengthy conflict in the middle east. If we only had more people who cared about the economy and the government's incompetency in managing it's duties, both parties would've been ejected from office and we'd have gotten a few more forward lookers in Washington. Too bad that'll never happen in my lifetime.
How ironic is it that Iraq eventually turned around, whereas we're just beginning to really see the seams crack in our economy?
I think patenting work done with public money is okay, as long as, like you said, the patent is licensed freely. This protects the work of the scientists, doctors, etc, as it pertains to credit for their work, but at the same time doesn't allow them to derive obscene profits off of public money.
There is a common belief that embryonic stem cells, because they have the potential to differentiate into any cell line instead of just one or two, are somehow "better" than the other myriad types of cells. This ignores the fact that it's much harder to stop ESCs from continuing to differentiate, which is why you get tumors at an alarming rate.
This is in turn rooted in another common incorrect notion, namely that stem cells repair injury by differentiating into new cells and tissue. The first decade of research in this field has largely disproved this notion. Instead, stem cells seem to alter the host response to injury, such that normal repair mechanisms function much more effectively. Stem cells tend to get stuck in the lungs when given intravenously, but still result in improved repair at remote sites; conversely, after direct injection of cells into a site of injury, most of those cells are someplace else in the body after 24 hours.
This is why the Geron trial is limited to spinal cord injuries that are less than two weeks old. Once scar formation has occurred, this therapeutic target is gone, and there is currently no notion of how to truly "reconstruct" a spinal cord in a long-standing paraplegic patient.
Bush disallowed GOVERNMENT funding of new cell lines, not private funding.
Bush actually disallowed any lab which receives government funding from doing research with new stem cell lines. That effectively meant that private funding didn't just have to pay for the research, but BUILDING AN IDENTICAL LAB for any university or organization that had a single government research grant.
Let me also mention that ALL stem cell research requires the destruction of life. A stem cell, whether embryonic or adult, is alive.
You are twisting the debate of the use of embryonic stem cells. It has nothing to do with objections over the destruction of the stem cells, it is how they are derived. All cells derived from humans are alive at some point, but the objection from many over using embryonic stem cells for research is the fact that they come from aborted people. As far as I'm concerned, that's what they are once they have a heartbeat. That fetus is then no longer just a fetus, but a human being. The debate to whether abortion is morally right is another argument for another time, but don't make this into an argument of whether using embryonic or adult stem cells are the same thing, because they are not. An adult willingly allows the use of their stem cells for research, whereas an unborn infant cannot make that decision.
"Bush is the devil!"
"Everything's the devil to you, Mama!"
So you are saying that adult stem cells are not as useful to treat health problems as embryonic stem cells? If that is the case, why are there treatments already in use that use adult stem cells, but this is the first clinical trial using embryonic stem cells?
The truth is that all men having power ought to be mistrusted. James Madison
Hurray for private charity, yes. But capitalism? I fail to see what capitalism has to do with with this. What makes you so sure this wouldn't have been done a long time ago if capitalism weren't around?
Tylenol can easily destroy your liver. There is a very small difference between the effective dose and the poisonous dose. Add alcohol, and the situation is even worse.