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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."

14 of 139 comments (clear)

  1. Food nor Drug by planckscale · · Score: 3, Interesting

    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.

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    Namaste
    1. Re:Food nor Drug by Retric · · Score: 4, Informative

      The FDA also approves medical devices like pacemakers. While the name might not cover such things the agency covers a lot of ground.

    2. Re:Food nor Drug by CrimsonAvenger · · Score: 5, Informative

      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.

      It should be noted that, since this study is privately funded, it could have been done at any time during the Bush or Clinton Presidencies.

      It should be further noted that, since this study uses one of the "approved" stem cell lines, it could have acquired Federal funding during the Bush Presidency (but not during the Clinton Presidency, since when Clinton was President NO stem cell research was getting Federal funding).

      In other words, this particular study provides no evidence whatsoever that anything has changed in any way, however slight.

      --

      "I do not agree with what you say, but I will defend to the death your right to say it"
  2. Gotta love the FDA by J'raxis · · Score: 3, Insightful

    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?

    1. Re:Gotta love the FDA by J'raxis · · Score: 3, Informative

      Not at all. I posted the full source above, but I'll excerpt the important part to demonstrate my point: "Aspirin deforms the unborn young of almost every animal species but humans and could not be marketed today if it had to go through FDA evaluations." In other words, its beneficial effects never would have been demonstrated because it would have been rejected before it even made it to human trials.

    2. Re:Gotta love the FDA by cabjf · · Score: 3, Informative

      Actually, they still advise against taking Aspirin while pregnant. Pretty much all my wife was allowed to take was Tylenol for her first trimester migraines. I bet Aspirin could have past those trials with warnings not to consume while pregnant or possible pregnant being the outcome.

    3. Re:Gotta love the FDA by Phortune · · Score: 3, Informative

      In fairness, aspirin is fairly hazardous for quite a few people because of, among other things, its blood thinning properties (e.g. bad for anyone on warfarin or other anti-coagulants); as well as for people with stomach ulcers, because of the irritation it can cause. There are so many other pain-killers available now, that are comparatively safe, that aspirin's use for its analgesic properties has all but died out in my country (UK). Like gad_zuki! said before me, lots of drugs are prohibited during pregnancy for myriad reasons. There are usually plenty of alternatives and the benefits seldom outweigh the risks for pregnant mothers.

  3. Re:Political BS by R2.0 · · Score: 3, Insightful

    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
  4. Re:About time by R2.0 · · Score: 3, Informative

    "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.

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    "As God is my witness, I thought turkeys could fly." A. Carlson
  5. Way to change the wording! by cosmicaug · · Score: 4, Informative

    Nice, how the wording got changed so that it says the opposite of what is conveyed by the CNN article!

    Slashdot article says:

    The stem cells come from the existing lines Pres. Bush approved federal funding for in August 2001.

    The source article actually states:

    The tests will use stem cells cultured from embryos left over in fertility clinics, which otherwise would have been discarded.

    And thus:

    Okarma said Geron did not use any federal funding for its research, and that the Bush restrictions had "devastated the field."

  6. Re:Another big corporate handout in the making. by jcnnghm · · Score: 5, Informative

    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
  7. Re:Yay Obama! by sumdumass · · Score: 5, Insightful

    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.

  8. Re:Speaking as a pro-life person here by jbeaupre · · Score: 3, Informative

    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

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    The world is made by those who show up for the job.
  9. Re:Another big corporate handout in the making. by pcolaman · · Score: 3, Insightful

    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?