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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 Baloroth ( 2370816 ) on Monday July 30, 2012 @12:02PM (#40818785)

    I think almost everyone is fine with government regulating dangerous unproven medical treatments with potentially horrific side-effects.

  • Re:Everything (Score:5, Insightful)

    by MozeeToby ( 1163751 ) on Monday July 30, 2012 @12:03PM (#40818803)

    Injecting stem cells randomly into the body is probably not a good idea. Stem cells aren't magically fix everything machines. There's a significant risk of cancer if nothing else and I'd be shocked if there weren't other potential issues as well. Why do we have people running around defending hack doctor's rights to inject them on unsuspecting and uninformed patients? And don't say the patients are informed, the research on risks hasn't even been completed yet, how could they possibly be informed of risks that the administering doctor doesn't even know about?

    Lets go to an extreme, how would you feel about the FDA telling a doctor that they can't inject stomach acid into a person's blood stream? Other than the risks being more obvious, what's the difference?

  • Good thing?? (Score:4, Insightful)

    by ZenDragon ( 1205104 ) on Monday July 30, 2012 @12:05PM (#40818829)
    This doesn't really sound like a good thing. I understand the desire to want to regulate unproven stem cell therapies. However, if history has shown us anything it is not regulation that they seek, but to stifle the industry entirely. Likely so the large pharma stock holders can hold on to their dividends. Maybe I am understanding this wrong? Anybody with more understanding of the matter, feel free to enlighten me.
  • by cayenne8 ( 626475 ) on Monday July 30, 2012 @12:10PM (#40818883) Homepage Journal
    Trouble is..this is gonna stop a LOT of use tx going on now with private physicians!!

    I know some doctors that have been having wonderful, and in some cases amazing results with this type of treatment. And now, sadly, you will have federal bureaucrats and miles of red tape standing in the way.

    I mean, it shouldn't be that bad...they are only taking YOUR own adult stem cells, and generally, injecting them into your problem areas, and allowing your own body to heal itself.....

    Now? Well, the feds will bog this down, and of course, you'll somehow involve big pharma (which does have its place)....and take what is proving to be an effective, low cost tx for many diseases....and make it more costly, and harder to perform.

  • by Githaron ( 2462596 ) on Monday July 30, 2012 @12:12PM (#40818897)
    I would think there should be government mandated transparency but the government should not decide which drugs we are allowed to take. If you are given all the known facts upfront, you should be able to make your own choice.
  • Right? (Score:4, Insightful)

    by J'raxis ( 248192 ) on Monday July 30, 2012 @12:13PM (#40818919) Homepage

    The FDA [eprci.net], a government bureaucracy, has "rights"?

  • It's about time (Score:3, Insightful)

    by drunken_boxer777 ( 985820 ) on Monday July 30, 2012 @12:19PM (#40818997)

    But perhaps it is too little too late. There are dozens, if not hundrends of these clinics set up outside the US. Many are in Asia or islands in the Caribbean/Atlantic. Who knows how many people have been defrauded.

    On the other hand, some of these shops might have reason to believe that stem cells only need to be extracted and applied to do their work. Jenner's small pox "vaccine" was just ground up scabs that he rubbed into a cut that he made in the patient's arm. Ridiculously crude by today's standards. But it worked. So perhaps (in their minds) some of these stem cell treatments could have merit.

    But I don't think that is likely the case. Applied stem cell biology is quite complex, particularly since the body tries to keep stem cells from becoming cancer. In humans, it is more of an issue because we reproduce relatively later in life and rear our young for far longer than most animals. In other creatures, like newts, it is less of an issue and they can regenerate entire limbs.

    Nearly all of these companies are probably well aware of how unlikely it is their treatment will help anyone, but can't say no to the truckloads of money. They don't want to perform the science that will lead to stem cell cures, and go after the crude "Jenner" method. The problem is that medical science has advanced significantly since the 18th century and conditions like joint pain don't exactly warrant unproven treatments in the same way that certain cancers might.

    I, for one, look forward to the FDA shutting these operations down.

  • by jellomizer ( 103300 ) on Monday July 30, 2012 @12:34PM (#40819179)

    " If you are given all the known facts upfront, you should be able to make your own choice."

    Yet people still start to smoke, tobacco. When learned about how it effects others in the area who shown not to make the choice, they still continue.

    Or you have stupid parents who believe some crazy nut job and will not vaccinate their children. In fear of a 0.001% increase of an other illness, while the vaccine will have a 5% chance of saving the child's life.

    Given the Fact there will be a charismatic conspiracy nut that will refute the claims, that will attract a big following.

  • by gmack ( 197796 ) <gmack&innerfire,net> on Monday July 30, 2012 @12:39PM (#40819239) Homepage Journal

    Shouldn't be that bad? They are taking cells and injecting them where they don't naturally occur. That can have side effects such as cancer [wired.com]. I'm not saying it's not promising but there have been far too many wild claims about it and far too many clinics treating it as some magic cure without any regard for patient safety.

  • by h4rr4r ( 612664 ) on Monday July 30, 2012 @01:14PM (#40819671)

    You know some doctors that are having amazing results, but can't manage to prove it in a double blind study?

    You know some conmen, not doctors.

  • by mutube ( 981006 ) on Monday July 30, 2012 @03:37PM (#40821265) Homepage

    They're not banning it, they're regulating it.

    I'd absolutely condone last-ditch treatment for individuals but then that's often done anyway - in a controlled and reportable manner. In that way we can learn something from the outcome and improve the treatment in the future so everyone benefits.

    This is about preventing organisations using stem cells as the latest snake oil cure-all while circumventing regulation on a 'oh but it's just your own cells so it's not a medical procedure' which is patently false.

    It's either an effective medical procedure and needs regulating, or isn't and they're guilty of false advertising.

Adding manpower to a late software project makes it later. -- F. Brooks, "The Mythical Man-Month"