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FDA Wins Right To Regulate Adult Stem-Cell Treatments 216

Posted by samzenpus
from the big-brother-cells dept.
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 vlm (69642) on Monday July 30, 2012 @11:56AM (#40818727)

    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.

    One interesting side effect is that dialysis treatment is now a drug.

    Law isn't logical, you can't p0wn it and get root permissions (unless you're a 1%er, in which case you are the law). But it is none the less weird that if dialysis was invented today, it would be considered a drug under than doctrine.

    • Re: (Score:3, Informative)

      by Baloroth (2370816)

      Not necessarily. This is a court decision, not a new statutory law. A significant (very very very significant) part of the job of a court is to decide over specific cases and whether the law, in word and in spirit, is supposed to apply to that case. They ruled that in this case (stem cells) it does. In the case of dialysis, they might not (probably wouldn't, since it is a proven long-standing and genuinely routine medical procedure). It is a very fine line, but that is what the courts are for: so that they

    • by dgatwood (11270)

      But it is none the less weird that if dialysis was invented today, it would be considered a drug under than doctrine.

      Not really. Any time you're connecting a device into somebody's veins or putting liquids into somebody's chest cavity, the government should regulate the safety and efficacy of the treatment. It's not like we're talking about foot massages here....

    • by jbeaupre (752124)

      Dialysis was already governed by the FDA as a device and through drug regulations. The machines are devices, the dialysate is a chemical formulation.

      I'm trying really hard not to call you a dumbass. Yes, I will take the higher ground and not call you a dumbass.

    • by Trepidity (597) <delirium-slashdot@@@hackish...org> on Monday July 30, 2012 @12:17PM (#40818979)

      A number of doctors do think dialysis should be better regulated than it is now, to ensure that patients are getting actually good care following scientifically validated practices. The two options are basically to regulate it as a drug, or as a medical device [thekidneydoctor.org].

  • by Schmorgluck (1293264) on Monday July 30, 2012 @12:00PM (#40818767)

    Since one of the FDA's roles is to check medical treatments for safety and efficience, this is consistent with its mission.

    Now it being able to do the job correctly is another matter entirely, regulatory capture seems to be the USA's national sport...

    • by nbetcher (973062)
      Food and DRUG Administration. Enough said.
    • I have a half way solution. Keep the FDA but make it an advisory board. This way you can still sell any herb or crazy therapy you like but those that want things that are proven to be effective can look for things that are FDA approved. If you tried every approved treatment with no results you might be desperate enough to try some crazy stuff.

  • 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.
    • Re: (Score:2, Informative)

      by Anonymous Coward

      The core concept here is that the treatments in question have not demonstrated that they:
      1. Are effective at treating the maladies for which they are prescribed.
      2. Are not likely to cause side effects that aren't well understood.
      3. Have disclosed all known risks to the patients prior to administering treatment.

      The FDA is the agency tasked with ensuring that medical treatments comply with those requirements. They were founded because the free market will left to it's own devices favor snake-oil salesmen who

    • Even if sale of these treatments was not regulated there is the issue of how someone is supposed to make a rational decision as to what the effectiveness and dangers of the treatment are, and a process for validating the ongoing quality of the products being used.

  • 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"?

    • Ah, well spotted... This wording is indeed problematic. Government bodies have no rights, only missions, and anything that isn't part of their missions is forbidden to them.

      • by CptNerd (455084)

        That's outmoded 18th Century thinking, we're so much more evolved now, and our Living Constitution needs to be rethought in this new age, with so many more smart people in government. Why, the intellectual capacity of 500+ Legislators, not to mention the tens of thousands of bureaucrats, is surely wiser than the handful of technologically ignorant Founders...

        • A constitution is not the act of a government, but of a people constituting a government; and government without a constitution is power without a right. All power exercised over a nation, must have some beginning. It must be either delegated, or assumed. There are not other sources. All delegated power is trust, and all assumed power is usurpation. Time does not alter the nature and quality of either.

          -Thomas Paine.

        • by P-niiice (1703362)
          No, no you're right. Plus, since I'm only 3/5 of a person, the medicine wouldn't hurt me as much if the claims were false!
  • Government-encroaching Luddite religion suppressing science and freedom!

    How'd I do?

    Or, maybe it's just a good idea to have some sort of vetting process before people start mass-injecting biological material into themselves.

  • 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 kimvette (919543)

      conditions like joint pain don't exactly warrant unproven treatments in the same way that certain cancers might.

      Right, right. It's better to put someone on opiates to manage the pain and send them driving home, or to inject them with cortizone and cause them to bloat up - and if the patient is female to develop hirsutism. Yes, it's far better to do that than to try something which has a very high potential of actually rebuilding the cartilage.

      • by h4rr4r (612664)

        How do we know it has a high potential of doing that?

        Please show us the studies. What we have instead is you suggesting we try random untested procedures instead of pain management that we know works. I would imagine the risk of unsightly hair is more manageable for the patient than a totally unknown outcome for what may well be no actual improvement at all.

      • a very high potential of actually rebuilding the cartilage

        Citation needed.

        I have a PhD in developmental biology (closely related to stem cell biology). I effectively work in the pharmaceutical industry. If it had been demonstrated that simply extracting, concentrating, and injecting stem cells actually rebuilt cartilage, you would see many legit biotech companies running this through the regulatory process as fast as possible. But you don't.

        Also, if you talk to any physician, FDA staffer, or pharma worker, you will realize there is a necessity to balance efficacy

    • The theory of how this works is that it is a purified version of microfracture [wikipedia.org], which is now prevalent (especially among athletes) and accepted. Microfrature works because the stems cells from the bone marrow form new cartilage, which produces hyaline cartilage material, but also lots of stuff you don't want, making the result inferior to pure hyaline cartilage (called fibrocartilage). So in theory, if you remove the crap (isolate the stem cells), you can get a more pure cartilage formation.

      It makes sens

      • by h4rr4r (612664)

        I claim I have a magic rock that has an 11000% percent success rate.

        I suggest we actually test both of them, with a real double blind study. Some folks get saline some get this crap.

      • Hmm. I am going to have to dig through some of the citations in that Wikipedia article. I am a bit skeptical, but need to see the science behind it to know how legit it is. Unfortunately, much of what I saw in the article seemed more like results from case studies rather than randomized trials.

        Thanks for the background.

    • by Nexus7 (2919)

      You said:
      "Applied stem cell biology is quite complex,..."

      That is the key here. You think it is complex, but looking at the postings above yours, and at least one followup to it, people are thinking that the FDA, scientists, the whole edumacationistic cabal, are making things too complex to preserve their authority. See for example, postings saying there's enough information out there that people can come to their own conclusions and decide for themselves. See how anti-vaccine kooks get copious air-time (any

      • Good point. Stem cell biology is complex, and not just because I, or a legitimate authority, says so. But some people don't want to believe that is the case, or think they are knowledgeable enough to review all the information and decide for themselves.

        I think the same mentality is at play with nuclear power plants. People think they have enough information to make an informed decision about whether a reactor should be built in their neighborhood, but that is not likely to be the case.

        I don't think people s

  • Wat? (Score:5, Funny)

    by Quiet_Desperation (858215) on Monday July 30, 2012 @12:22PM (#40819055)

    Quick! I need an ideological purist to tell me what to think about this!

  • The FDA's job is to require that drugs are "safe and effective". Most new drugs fail those tests during the development process. Some work in test tubes, but not in animals. Some work in animals, but not in humans. Some are unsafe for some fraction of the population. Some look useful in humans at first, but a few years downstream, haven't improved health or survival rates. Only about 13% of small-molecule drugs, and 32% of large-molecule drugs that start phase 1 clinical testing make it to actual use.

    Th

  • The "right to healthcare" officially does not exist as long as government can totally block you from getting the treatment you want.

Do not simplify the design of a program if a way can be found to make it complex and wonderful.

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