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Biotech Science

First Human Embryonic Stem Cell Study Approved 139

Posted by ScuttleMonkey
from the new-things-to-argue-about dept.
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."
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First Human Embryonic Stem Cell Study Approved

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  • About time (Score:0, Informative)

    by Anonymous Coward on Friday January 23, 2009 @02:13PM (#26578871)

    Thanks Bush for making it so life-saving treatment research got delayed so much. You stupid fuck.

  • by Anonymous Coward on Friday January 23, 2009 @02:22PM (#26579027)

    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?

    Ummm... They may be slow and crappy, but ever? Methinks you may exaggerate...

  • by J'raxis (248192) on Friday January 23, 2009 @02:23PM (#26579053) Homepage

    Chapter six [ruwart.com] of Healing Our World: The Other Piece of the Puzzle by Dr. Mary J. Ruwart.

  • Re:Food nor Drug (Score:5, Informative)

    by Retric (704075) on Friday January 23, 2009 @02:25PM (#26579085)
    The FDA also approves medical devices like pacemakers. While the name might not cover such things the agency covers a lot of ground.
  • by J'raxis (248192) on Friday January 23, 2009 @02:27PM (#26579103) Homepage

    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.

  • Re:About time (Score:3, Informative)

    by R2.0 (532027) on Friday January 23, 2009 @02:32PM (#26579183)

    "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.

  • by cabjf (710106) on Friday January 23, 2009 @02:34PM (#26579201)
    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.
  • by cosmicaug (150534) on Friday January 23, 2009 @02:37PM (#26579261)

    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."

  • Re:Food nor Drug (Score:5, Informative)

    by CrimsonAvenger (580665) on Friday January 23, 2009 @02:46PM (#26579375)

    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.

  • by jcnnghm (538570) on Friday January 23, 2009 @02:55PM (#26579513)

    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

  • by Doc Ruby (173196) on Friday January 23, 2009 @03:03PM (#26579639) Homepage Journal

    There are over 400,000 frozen embryos [ivf.net] 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.

  • by jbeaupre (752124) on Friday January 23, 2009 @03:13PM (#26579803)
    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 [wikipedia.org]
  • by Phortune (1455837) on Friday January 23, 2009 @03:58PM (#26580665)
    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.
  • by mr_mischief (456295) on Friday January 23, 2009 @04:07PM (#26580801) Journal

    IANA physician or pharmacist, so this isn't qualified medical advice. Do research from better sources than Slashdot when health is concerned. This is just a tip to a couple of those sources.

    They actually recommend against aspirin as a
    fever reducer in children under the age of about 16, too. Reye's syndrome is a rare but dangerous sickness that can be triggered in victims of the chicken pox or flu viruses when given aspirin.

    Any viral infection, particularly one in which the first symptom is fever, should not be treated with aspirin. This is true according to the NIH even in adults, but I've always heard it was especially true for children.

    See the pages about Reye's at MedicineNet [medterms.com], WebMD [webmd.com], or the US National Institutes of Health [nih.gov] or ask your doctor for more info.

    Aspirin also has other contraindications, but it has many positive uses as a medicine. Very little in life is without drawbacks, unfortunately.

  • Re:Food nor Drug (Score:2, Informative)

    by plnix0 (807376) on Friday January 23, 2009 @08:15PM (#26584077) Homepage

    ah hah, I see, like botulinum toxin and other toxic medicines. Yes that makes sense now. thanks!

  • the others are worse (Score:3, Informative)

    by r00t (33219) on Saturday January 24, 2009 @01:29AM (#26585939) Journal

    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.

  • Re:Food nor Drug (Score:1, Informative)

    by Anonymous Coward on Saturday January 24, 2009 @01:32AM (#26585963)

    > it could have been done at any time during the
    > Bush

    No. They filed the IND (investigational new drug) application over a year ago. The FDA placed a hold on the start of the clinical trial. Not until after Obama's inauguration was it lifted.

  • by Phortune (1455837) on Saturday January 24, 2009 @08:44AM (#26588021)
    Outside of the US, Tylenol is known as paracetamol; one of the metabolic intermediates of which is extremely toxic and since paracetamol is metabolised in the liver, it is there that it accumulates and has its toxic effect. The toxic dose of paracetamol varies among individuals because of the polymorphic nature of the genes for the enzymes involved and because of differing rates of metabolism of this toxic intermediate. That said, the fatal toxic dose for a given individual is fairly high compared to the 500-1000mg (4000mg max. daily) recommended dosage. It would be considerably lower for a developing foetus, however, I am unsure as to how much paracetamol would be able to cross the placental membrane into the foetus' bloodstream; or indeed if the foetus would be able to metabolise the paracetamol (and thus produce the toxic intermediate, NAPQI). Pregnant mothers should know better than to drink more than a small glass of wine, and certainly not in conjunction with any painkiller. Paracetamol is the lesser of many possible evils. I hope this clears matters up?

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