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FDA Regulating Your Stem Cells As Interstate Commerce 332

Posted by timothy
from the oh-that's-raich dept.
New submitter dcbrianw writes "A non-surgical procedure that treats joint pain involves removing stem cells from a patient's blood and reinserting them into the joint. The facility conducting these procedures resides in Colorado, but because it orders equipment to perform the procedure from outside of Colorado, the FDA claims it must regulate this process and that it can classify stem cells as a drug. This issue opens the debate of what the FDA, or other regulatory bodies, may regulate within each of our own bodies." Quick: Name five activities with no possible plausible effect on interstate commerce.
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FDA Regulating Your Stem Cells As Interstate Commerce

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  • by DoofusOfDeath (636671) on Thursday February 02, 2012 @05:37PM (#38908191)

    Can anyone comment on why the Supreme Court has historically allowed the Commerce clause to apply to absolutely anything that could be remotely, however ridiculously, be considered related to interstate commerce, and thus trample states' rights?

    Is this simply a perennial sin of the Court, or is there a sound Constitutional basis for it?

    • by nschubach (922175) on Thursday February 02, 2012 @05:39PM (#38908219) Journal

      I was always taught that it was enacted to prevent States from restricting trade between neighboring states... not to prevent trade.

      • by hey! (33014) on Thursday February 02, 2012 @06:44PM (#38909109) Homepage Journal

        I was always taught that it was enacted to prevent States from restricting trade between neighboring states... not to prevent trade.

        Nobody advocates regulation to *prevent* trade in general. Some trade is *always* restricted by regulation, but the intent and effect of the regulation may be to encourage trade overall. For example if there weren't federal standards for auto emissions, more states might follow California's lead and develop their own regulatory standards. By establishing a nation-wide regulatory regime, a larger and more efficient market results.

        On the other hand federal laws *do* effectively prevent *in state* trade in recreational drugs. If anything that's much *more* of an overstepping of federal powers, because the intent is not to provide a uniform regulatory regime for trade in recreational drugs across the country, but to *forbid* the use of recreational drugs *anywhere*. It's seldom questioned because both major parties agree that recreational drug use should be forbidden everywhere.

        This is Commerce Clause of the US Constitution: "[Congress will have the power] To regulate Commerce with foreign Nations, and among the several States, and with the Indian tribes. That's it. That's all there is. The plain text of the clause doesn't simply prevent Congress or the States from restricting trade to favor one state's produce over another (that's actually covered in Article 1, Sections 9 and 10). The clause appears to give Congress power to regulate interstate commerce *for any reason it sees fit*. If so, Congress can intentionally *restrict trade* between the states if it believes that trade is not in the national interest. And it does, and will continue to do so. If there's ever successful nation-wide restrictions on abortion, those restrictions will be made possible by the Commerce Clause.

        You could reasonably argue that this is *too* much power to give Congress. It wouldn't be the only case. I think the powers the Constitution grants Congress in copyrights and patents almost certainly enable Congress to pass laws that would be repulsive to the framers. But the framers while intending to create a government with circumscribed and carefully enumerated powers couldn't possibly have anticipated *all* the uses to which any one power could be put.

    • by pscottdv (676889)

      Can anyone comment on why the Supreme Court has historically allowed the Commerce clause to apply to absolutely anything that could be remotely, however ridiculously, be considered related to interstate commerce, and thus trample states' rights?

      Is this simply a perennial sin of the Court, or is there a sound Constitutional basis for it?

      I certainly cannot, since the states rights are enshrined in the 14th amendment and the commerce clause is in the original constitution, it has never made sense to me. The amendments are supposed to supercede the consititution. That's the whole point of having them.

      • by sconeu (64226) on Thursday February 02, 2012 @05:57PM (#38908479) Homepage Journal

        Actually, States Rights are enshrined in the 10th Amendment. The 14th establishes some federal powers over the States.

        • by GodInHell (258915)
          And amendments must be drafted to specifically supersede previous limitations or grants of power in the constitution or amendments in order to have that effect -- but what the fuck, rah rah state's rights -- who cares what the bookish dweebs say.

          -GiH
          • Re: (Score:2, Insightful)

            by Anonymous Coward

            I never understood why some people thinks states rights are oh so wholesome. Some of the most corrupt and evil politics have been enshrined at the state level.

            • by jamstar7 (694492)
              True enough, but that made it a fairly local problem, not a national problem. Once you got across state lines, you were ok. It's like driving from a dry county to a wet county to pick up a 12 pack. Illegal to own at home, but cross the county line and they have package stores lined up just waiting to sell you whatever booze you want.
            • by marnues (906739)
              They're wholesome because we can hide our personal prejudices behind states-rights. Or county-rights if it's the state that's offending us.
            • by tnk1 (899206) on Thursday February 02, 2012 @08:19PM (#38910187)

              Mostly because the state governments are closer to the people they represent, and are probably (slightly) more concerned about the welfare of the individual people they represent. Obviously, some state governments are pretty huge too, so that is going to be admittedly relative. Still, the Federal Government is gigantic, and you will often find that it tends to represent only the key groups for getting elections won, which is ultimately a very small number of people when you consider it.

              I think the best form of democracy consists of the most local form that can get the job done. Having a national army on the Federal level is going to be necessary to protect the whole country from larger aggressors, and certainly it is a bad idea to have localized foreign policy, but do we really need the Federal government to synchronize education, for instance? I'd say not, and the arguments that I hear from some people along the lines of "we can't let the hicks stop teaching evolution," or the like, I think is an invalidation of the principle of government by the People. I also feel that such polarization starts happening when individuals feel they need to become more and more radicalized to even be heard in the larger governmental venues.

              Having government at a local level does not always prevent corruption, but it does allow people to actually have a chance to have a say in government if they try to exert their will and interest. To even be noticed on a state and Federal level, you start needing the massive cash reserves that only things like special interest groups or corporate sponsorships can get for you. There's less diversity in solutions, and they tend to be executed more on a basis of political expediency rather than need or efficiency.

              • by GodInHell (258915)

                I think the best form of democracy consists of the most local form that can get the job done. Having a national army on the Federal level is going to be necessary to protect the whole country from larger aggressors, and certainly it is a bad idea to have localized foreign policy, but do we really need the Federal government to synchronize education, for instance? I'd say not, and the arguments that I hear from some people along the lines of "we can't let the hicks stop teaching evolution," or the like, I think is an invalidation of the principle of government by the People. I also feel that such polarization starts happening when individuals feel they need to become more and more radicalized to even be heard in the larger governmental venues.

                You did catch that whole thing where Texas basically gets to dictate national policy on education because it writes mandates for the publishers and the publishers don't want to make multiple prints of the book -- so we all get what Texas wants. Education policy isn't nationalized by the Feds. It's nationalized by the book publishers.

                -GiH

                • by tnk1 (899206)

                  Well, honestly, if a big state like California wanted separate textbooks, I am certain they could create a market big enough for another textbook publisher to spring up unless that other textbook company complied.

                  The very fact that there can be One Textbook to Rule them All, is indicative that Federal education policy and monies have synchronized the subject matter to such a degree that the differences between state policies are too small to justify having a separate textbook. Since I sincerely doubt that

              • by anagama (611277)

                the arguments that I hear from some people along the lines of "we can't let the hicks stop teaching evolution,"

                One thing to point out to people who make this argument, is that the same blanket law that allows the teaching of evolution, could turn into a blanket law that forbids it. Imagine Santorum setting education policy. And before anyone says the President can't do that -- look at what Obama has done and compare it to his constitutional powers -- GWB was right when he called the constitution "just a p

      • by atriusofbricia (686672) on Thursday February 02, 2012 @08:52PM (#38910527) Journal

        Can anyone comment on why the Supreme Court has historically allowed the Commerce clause to apply to absolutely anything that could be remotely, however ridiculously, be considered related to interstate commerce, and thus trample states' rights?

        Is this simply a perennial sin of the Court, or is there a sound Constitutional basis for it?

        I certainly cannot, since the states rights are enshrined in the 14th amendment and the commerce clause is in the original constitution, it has never made sense to me. The amendments are supposed to supercede the consititution. That's the whole point of having them.

        Point of order... States do not have Rights. States have Powers, People have Rights. :)

    • by Anonymous Coward on Thursday February 02, 2012 @05:51PM (#38908395)

      This came up in a constitutional law class I took. The answer we came up with is that (1) we (the general populace) want the federal government to be able to regulate these things, (2) constitutional amendments are nigh impossible, and (3) it can be justified... the logic is tortured, and I doubt any intellectually honest person would really believe it, but it can be done.

      You probably hate point (1), but think about when it really started happening... the depression was here, people were miserable, they wanted someone to save them, so they turned to the government. And that still happens today. Turn on the news, and when you hear about a major problem, there will be a commentator following hard upon saying "where were the regulators in all of this?!" and people will nod their heads.

      Anyway, that's the answer: the majority of people want it to be the way it is.

    • by crow (16139)

      I'm not a legal historian, but I think the case that convinced the Supreme Court to take a broad view of the Commerce Clause was a civil rights law that required equal access to hotels and restaurants, regardless of race.

      http://en.wikipedia.org/wiki/Commerce_Clause [wikipedia.org]

      Yup. The New Deal was the first expansion of the Commerce Clause, and after the civil rights law was upheld, it was pretty much all over.

      • by Trepidity (597)

        There was another minor opportunity to stem the tide with some federalist arguments about medical marijuana: people growing their own marijuana, legal under state law, noncommercially, for private use on the premises, argued that this could not possibly be "interstate commerce", but Antonin Scalia of all people wrote an opinion arguing that it was. So you can add "the drug war" as the 3rd wave of things...

      • A test case of the New Deal was if the Federal Government could regulate a wheat field that was grown on private land whose purpose was to feed the people who owned the land – and thus would never be sold or transferred across state lines..

        The Supreme Court said yes.

        I can understand and approve that common carriers have to be open for all (see parent’s comment). The wheat case just strains my poor brain.

    • by 0123456 (636235) on Thursday February 02, 2012 @06:00PM (#38908501)

      Can anyone comment on why the Supreme Court has historically allowed the Commerce clause to apply to absolutely anything that could be remotely, however ridiculously, be considered related to interstate commerce, and thus trample states' rights?

      Because it's the only way for a power-crazed Federal government to impose their laws across the country.

      • Generally speaking, because the drafters did not explain what they meant by the term "commerce" when they drafted the Constitution, and the Court has interpreted Congressional power to regulate commerce between the States as encompassing the channels, instrumentalities, and activities of interstate commerce.

        --AC

    • Re: (Score:3, Insightful)

      by JBMcB (73720)

      Blame FDR. The supreme court was striking down his New Deal regulations and reforms left and right as they didn't jive with the whole "regulating interstate commerce" thing. So he packed the court with statists who rubber-stamped nearly every program and rule with tortured interpretations of the commerce clause.

      The side-effect is that the federal government can now regulate nearly everything you do. Unintended consequences and all.

      • by Goobermunch (771199) on Thursday February 02, 2012 @06:19PM (#38908739)

        Please, please, please. Learn your history.

        FDR did not pack the court with statists. In fact, the proposal he had advanced (of adding more justices to the supreme court), never went through. Instead, one justice on the court changed his mind about how to approach these matters and turned what had once been a 4-5 court into a 5-4 court. http://en.wikipedia.org/wiki/The_switch_in_time_that_saved_nine [wikipedia.org]

        But go ahead and blame FDR, that's easier than learning about history.

        --AC

        • Please, please, please. Learn your history.

          FDR did not pack the court with statists. In fact, the proposal he had advanced (of adding more justices to the supreme court), never went through. Instead, one justice on the court changed his mind about how to approach these matters and turned what had once been a 4-5 court into a 5-4 court. http://en.wikipedia.org/wiki/The_switch_in_time_that_saved_nine [wikipedia.org]

          But go ahead and blame FDR, that's easier than learning about history.

          --AC

          That is the only reason he didn't pack the court. The previous post is still correct, you just explained the precise method and did point out the error that FDR didn't have to pack the court to get his way. Either way, it's still the New Deal and FDR's fault. Greatest President my ass.

    • by ackthpt (218170)

      Can anyone comment on why the Supreme Court has historically allowed the Commerce clause to apply to absolutely anything that could be remotely, however ridiculously, be considered related to interstate commerce, and thus trample states' rights?

      Is this simply a perennial sin of the Court, or is there a sound Constitutional basis for it?

      Probably because of that Constitution. Burning is too good for it.

      We should shoot it, too, with our Constitutionally protected guns.

    • by Kohath (38547)

      They wanted to uphold the expansion of Federal power. They used the Commerce clause as a justification to pretend the Constitution allows this Federal power. When you care about power more than you care about anything else, you can always find a justification to convince yourself you're right to have power. Given this reasoning, any basis can be a "sound Constitutional basis".

    • by StikyPad (445176)

      Because there's no limits on (or indeed, definitions of) Interstate Commerce in the Constitution. That's the problem with vague laws that people argue are "straightforward," though if they're defined explicitly and thoroughly, then people complain that they're too complicated.

    • I think they are poised to dial that back quite a bit when they ditch the individual mandate and likely then entire Obama Care Act.

    • by PortHaven (242123)

      What I never understood. Is why the SCOTUS decided that the Balanced Budget Amendment was unconstitutional on the grounds that budget was the responsibility of Congress.

      And yet,somehow does not see any issue with the War Powers Act which has allowed 1/2 a century of wars to go undeclared by Congress.

      Go figure,....hypocrisy.

  • by mosb1000 (710161) <mosb1000@mac.com> on Thursday February 02, 2012 @05:37PM (#38908193)

    I think maybe where they've gone off track is they are thinking they can regulate anything related to interstate commerce, rather than just the commerce itself.

    • Re: (Score:2, Funny)

      by Anonymous Coward

      Your post itself interferes with interstate commerce. I googled your email and you seem to be from california. I was going to take my next vacation there but now that I know you hate america, I will probably not. I will also tell my friends not to go there. I'm sure you clearly see how your terroristic behavior has no place in a free society like ours! The DHS is on the way...

    • by roman_mir (125474)

      They've gone off the track because they moved away from the point of that clause completely, and the point was to ensure that States do not engage in anti-competitive behaviour, so for example it is wasteful and corrupt to require that say a medical or a financial professional has to register as such in every State separately, instead of ensuring that registered once in one State, the person can then practice his trade across State borders.

      The federal government has failed in this completely, why completely

  • DMT (Score:5, Informative)

    by Hatta (162192) on Thursday February 02, 2012 @05:37PM (#38908199) Journal

    Dimethyltryptamine (DMT [wikipedia.org]) is a naturally occuring endogenous neurotransmitter that is also a Schedule I drug.

  • by Karmashock (2415832) on Thursday February 02, 2012 @05:39PM (#38908217)

    Interstate commerce is a catch all the government uses when it has no right to do something and wants to do it anyway.

    What I find amusing about this is that so many people are upset about this stem cell thing but aren't upset by all the things that created the precedence that allowed them to make these claims in the first place.

    if you want this to stop then the inter state commerce clause needs to get it's wings clipped. That's the problem. Go to the source.

    • Re: (Score:3, Insightful)

      by ScentCone (795499)
      At least this abuse of the Commerce Clause involves actual economic activity. Obamacare involves garnishing your wages or potentially landing in you federal prison for not participating in interstate commerce with ... a health insurance company in your own state. It's a good thing we passed that law so we could see what was in it, Nancy!
  • by Anonymous Coward on Thursday February 02, 2012 @05:39PM (#38908223)

    If you grow your own food, you won't buy it from another state. Therefore, growing your own food affects interstate commerce. At least that's what the Supreme Court decided when a farmer fed his own animals with his home grown food.

    http://en.wikipedia.org/wiki/Wickard_v._Filburn

  • by jamstar7 (694492) on Thursday February 02, 2012 @05:41PM (#38908237)
    And here I thought Roe vs Wade claims the State has no right to tell you what you can or cannot do with your body.

    Oh, wait, they're trying to invalidate Roe vs Wade. Too many loopholes, I guess...
  • by NovaSupreme (996633) on Thursday February 02, 2012 @05:45PM (#38908287)

    You cannot do anything without having some effect on interstate commerce.
    Entropy of whole universe must increase with time, so everything is connected including interstate commerce and your poop.
    Alternatively, if you are alive and you breathe, you must be changing composition of air a little bit, and since all air is connected, you are modifying the air composition of the whole country. This promotes traders who sell purified air across states.
    Alternatively, if you buy an out-of-state merchandise, of course you impact interstate commerce. On the other hand, if you dont buy from an out-of-state merchant, of course you impact interstate commerce, as your (lack of) activity will have negative effect on the price of the merchandise.

    Oh, this would be so funny if this clause were not the most abused clause in the constitution, that has been taken WAAAAAY out of its context.

    • by lgw (121541)

      Entropy of whole universe must increase with time, so everything is connected including interstate commerce and your poop.

      Ah ha! So that's where the federal government gets the right to regulate how much water I use when I flush my toilet! I always wondered how they rationalized that.

  • Compounds in saliva promote healing and immune response. Are those drugs? Will they soon be regulating the practice of licking wounds?
    • by Obfuscant (592200)

      Compounds in saliva promote healing and immune response. Are those drugs? Will they soon be regulating the practice of licking wounds?

      If a doctor takes your saliva, extracts certain parts, and uses it as a medical treatment, I sure hope so. Quackery is not a Good Thing in medicine.

      • by pclminion (145572)

        Quackery is not a Good Thing in medicine.

        I thought the distinction between quackery and medicine was sound experimental techniques, solid statistics, reproducible results and peer review. Not a sign-off by a three-letter-acronym government agency. Oh well, silly me.

        • by Obfuscant (592200)

          I thought the distinction between quackery and medicine was sound experimental techniques, solid statistics, reproducible results and peer review. Not a sign-off by a three-letter-acronym government agency. Oh well, silly me.

          That sign-off being based on all the former stuff. Anyone can say they've done all the science and prove whatever they want. Kevin Treudau does it all the time. Makes a bundle selling books about it. Rubbing beets on your butt eliminates cellulite. Drinking frog piss relieves constipation. That kind of stuff.

          Now, you'll have to explain how these folks did that research when there is a ban on stem cell research in the US, which includes Colorado. Oh, sorry, that's a ban on federal funding for embryonic ste

  • Hahahahahaha (Score:5, Insightful)

    by roman_mir (125474) on Thursday February 02, 2012 @05:48PM (#38908335) Homepage Journal

    This is precious, why have a Constitution if you can 'interpret' it at all, so in reality nothing that government wants to do can be prevented?

    I mean, eventually you BREATH AIR, right? Doesn't air cross State boundaries? That's it - your very existence can be regulated by the federal government completely even if you never leave your particular State.

    If you grow your own food in your own garden and you don't even buy anything from anybody - well, by gov't logic (and it's true, it already was argued) you are involved in 'interstate commerce'. Why? Because you aren't buying things from other states, so you are clearly preventing their sales, which means you are interfering with inter-state commerce, which means you are engaged in it.

    Hawaii is one state, yet it has 'interstate highways' in it (H-1), but it's one State. So how is that possible? Well the answer is obvious - when federal government wants to build a highway system in order to interfere with States rights logic exits the doors.

    • This is precious, why have a Constitution if you can 'interpret' it at all, so in reality nothing that government wants to do can be prevented?

      Because the people who wrote the Constitution expected it to be regularly amended, so they wrote it using very vague terms that they though could be amended over time.

      Later, when the Supreme Court established itself as arbiters of what is and isn't Constitutional, most of those same people were still around and could have stopped this... with a Constitutional amendment. But they didn't.

      And then it became way too difficult to get an amendment passed, but there's still a Supreme Court and that vaguely worded

  • by truavatar (2463178) on Thursday February 02, 2012 @06:04PM (#38908569)
    Glenn Beck's "theblaze.com" is your sole source for this front page post? Thanks slashdot.
    • by gewalker (57809) <Gary DOT Walker AT AstraDigital DOT com> on Thursday February 02, 2012 @06:21PM (#38908763)

      I don't care whether it comes from theblaze, huffpost , the national enquirer, or the KKK. If the the story is accurate and relevant (sufficiently interesting, funny, etc.)? If yes, the front page is fine by me. If you have a choice of sourcing the article, a less incendiary source would be a wiser choice.

      • by Obfuscant (592200)

        If you have a choice of sourcing the article, a less incendiary source would be a wiser choice.

        How about using one that doesn't immediately pop up a large white box with a demand that you subscribe to their newsletter, and try opening up a couple of other popup windows at the same time? How about just avoiding sites like that?

        abuse@theblaze.com will probably enjoy the subscription I gave him.

      • I can't remember the exact quote, nor who it was that said it, but it goes something like this:

        Everything he said was accurate, and not a word of it was true.

        Do we really want random doctors performing do-it-yourself stem cell treatments on the fly with no oversight? Just because they come from your body doesn't mean they are harmless, I bet there are any number of chemicals, bacteria, or cell lines that could be isolated from the human body and put back into a different part and would lead to problems. K

        • I can't remember the exact quote, nor who it was that said it, but it goes something like this:

          Everything he said was accurate, and not a word of it was true.

          Do we really want random doctors performing do-it-yourself stem cell treatments on the fly with no oversight?

          Whether "we" want this or not, isn't the issue that was raised. The question was "is this really interstate commerce?" Those who don't want constraints on the scope of Congress' regulatory power should be honest about it, propose an amendment to the Constitution that says "Congress shall have the power to regulate whatever the fuck it wants to regulate", and get it passed. Put an end to the FDR-spawned charade of callings things interstate commerce which, by any non-silly definition, aren't. I doubt that ev

      • Re: (Score:3, Informative)

        by truavatar (2463178)
        It is not accurate. That is my point.

        theblaze.com's sole source is the Alliance for Natural Health's article which grossly misrepresent the FDA's case, as you can see if you read the FDA's motion for summary judgement:

        http://www.hpm.com/pdf/blog/GovernmentSupportforSummaryJudgmentMotion.pdf [hpm.com]

        The article is about as useful as if it had come from the National Enquirer.
      • by geekoid (135745) <dadinportland&yahoo,com> on Thursday February 02, 2012 @08:21PM (#38910217) Homepage Journal

        It isn't. It's twisted and incorrect.

        For the record; when a source has a history of twisting, lying, and making things up, they loose any credibility. I don't want to see them on the front page. By changing their ways, they can earn front page.

  • When I'm sued by some conglomerate, for having the temerity to take my biomass across state lines, donate blood or some such, because they've got some damn patent on it.

  • by aklinux (1318095) on Thursday February 02, 2012 @06:57PM (#38909287) Homepage
    I suppose this means that now I will need FDA approval before inserting sperm into a womans body?
  • by pesho (843750) on Thursday February 02, 2012 @07:32PM (#38909755)

    This is a moronic summary of a stupid article. This is not about FDA regulating your stem cells, it is about FDA regulating snake oil salesmen, before somebody gets hurt.

    Some schmuck finds a loophole in the law that allows him to perform for profit untested medical procedures with questionable (to put it mildly) outcome. FDA has two options:

    1. Ignore him and when somebody gets hurt get dragged to congress as a showpiece of a useless government bureaucracy.

    2. Cover their bases and use all (no mater how questionable) authority that it can muster to try to shut him down.

    Option one is a loosing proposition. Option two is a win-win no-matter how the court decides. If the court allows this to fly (unlikely) they win. If the court laughs at their arguments (more likely) they have covered their asses big time. Now they can turn to congress and say 'We have done what we can, it is your turn now to decide if this should be regulated'. In addition, at any point in the future when a similar situation pops up they are absolved from responsibility.

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