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Biotech Government Medicine Science

FDA Wins Right To Regulate Adult Stem-Cell Treatments 216

ananyo writes "A court decision on 23 July could help to tame the largely unregulated field of adult stem-cell treatments. The US District Court in Washington DC affirmed the right of the Food and Drug Administration (FDA) to regulate therapies made from a patient's own processed stem cells. The case hinged on whether the court agreed with the FDA that such stem cells are drugs. The judge concurred, upholding an injunction brought by the FDA against Regenerative Sciences, based in Broomfield, Colorado. The FDA had ordered Regenerative Sciences to stop offering 'Regenexx', its stem cell treatment for joint pain, in August 2010. As Slashdot has noted before, they are far from the only company offering unproven stem cell therapies."
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FDA Wins Right To Regulate Adult Stem-Cell Treatments

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  • by Anonymous Coward on Monday July 30, 2012 @11:52AM (#40818681)

    Liberals are happy with the expansion of the government.

    Conservatives are scared shitless that without this power someone might smoke something they found in their backyard.

  • by englishknnigits ( 1568303 ) on Monday July 30, 2012 @12:30PM (#40819133)
    Milton Friedman addresses this:
    http://www.hoover.org/multimedia/uncommon-knowledge/26936 [hoover.org]

    Here is the excerpt:
    ROBINSON: The Food and Drug Administration which regulates everything from the drugs that pharmaceutical companies may put on the market to the ingredients in items we purchase off the grocery store shelves. Let me give you an example- Thalidomide [FRIEDMAN Everybody's favorite example...] Well I may be leading with my chin on this one but I'm going to lead with it anyway. 50's and 60's it is marketed in Europe as a drug to help women get through the nausea that they sometimes experience during pregnancy. The Food and Drug Administration said it had been inadequately tested in the United States and forbade it to be marketed in this country with the result that thousands of children were born with horrible birth defects in Europe to mothers who had used Thalidomide but that didn't happen to American children, because the FDA had intervened and kept that drug off the market. Thank god for the FDA, right?

    FRIEDMAN Wrong [ROBINSON Alright, why?] this is a case in which they did save lives, this was a good case, but suppose they are equally slow in adopting a drug which turns out to be very good and beneficial. How would you ever see the lives that are lost because of that? You're an FDA official, you have a question of whether to approve or disapprove a new drug. If you approve it and it turns out to be a bad drug like Thalidomide, you're in the soup, your name is going to be on every front page [ROBINSON cost me my job, I get hauled up to Congress to testify..] right. On the other hand if you disapprove it, but it turns out to be good, well then later on you approve it four or five years later, nobody's going to complain about the fact that you didn't approve it earlier except those greedy pharmaceutical companies that want make profits at the expense of the public, as everybody will say. So the result is that the pressure on the FDA is always to be late in approving. And there's enormous evidence that they have caused more deaths by late approvals than they have saved by early approval.

  • by Rob Riggs ( 6418 ) on Monday July 30, 2012 @01:08PM (#40819607) Homepage Journal

    I wonder it Friedman remembers why the FDA was needed in the first place? The FDA *was a response* to an imperfect market. If it's doing what Milton says it's doing, then the FDA is doing exactly what it is supposed to do!

    You know that economics as a science is fundamentally flawed when it expects that people are out to serve their best interests.

    People are idiots. A person may be smart, but people are stupid and have no idea what is in their best interest. People's rational and irrational fears and impulses can be preyed upon. Marketing is all about making people make *stupid economic choices* with limited and biased information. Economics might actually work if marketing didn't exist to exploit humanity's fundamental frailties. Until then, pardon me if I don't listen to the likes of Friedman when it comes to government policy on this topic. Our must fundamental fear is fear of death. And the FDA exists to prevent that natural fear from being preyed upon by the unscrupulous.

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