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FDA Regulating Your Stem Cells As Interstate Commerce
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.
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 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.
Dimethyltryptamine (DMT) is a naturally occuring endogenous neurotransmitter that is also a Schedule I drug.
Give me Classic Slashdot or give me death!
medical marijuana grown and consumed and never crosses state lines can still be regulated because of the commerce clause, according to the Supreme Court.
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.
I've decided to stop wasting my time responding to AC trolls/sockpuppets... so if you want a response from me... login.
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
... to report the issue objectively. It seems to be a rather religious/right-wing kind of a place. That said, could be something here...
The real reason the FDA is trying to step in is that this is a procedure is a medical scam. No different than if I offered to cut off the lobes of your ears to treat deafness.
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...
Understanding the scope of the problem is the first step on the path to true panic.
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A modicum of facts
-Clio
Karma: Bad (mostly from not giving a fuck)
Blog: http://clintjcl.wordpress.com
1) Breathing? ... ...I'll get back to you once I confirm this post meets FDA regulations.*
2)
*(This post only allowed in New York, USA. Do not view, store, or transmit this post unless within the state of New York. Failure to comply may be a federal crime and could result in fines and jail time. By continuing to read this post you accept these terms.)
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.
Compounds in saliva promote healing and immune response. Are those drugs? Will they soon be regulating the practice of licking wounds?
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.
You can't handle the truth.
I lost count, is that 5 things, 6 things, or just 1?
It's the government's "get out of jail free" card to regulate anything they want. If you're doing something involving interstate commerce, clearly that affects interstate commerce. If you choose to avoid doing anything that involves interstate commerce, well then obviously that intentional lack of interaction has an effect on interstate commerce as well!
This Space Intentionally Left Blank
My sunlight comes from out of state, too. Should we that with usage regulations and fees?
Not sure I follow you... from your own link:
It sounds to me like this procedure would surely fall under the medication, biopharmaceutical, or blood transfusion category... can you explain for us slow kids why this treatment would be (or should be) exempted? Genuinely curious, because it seems to me that regulating treatment for a medical condition like this would fall within the FDA's jurisdiction.
Growing wheat for your own personal consumption and the feeding of your own livestock. http://en.wikipedia.org/wiki/Wickard_v._Filburn
Genuinely curious, because it seems to me that regulating treatment for a medical condition like this would fall within the FDA's jurisdiction.
Now you just need to explain how the FDA gets the power to do that from the Constitution.
It's not blood or a blood transfusion, and it's only a drug because they said it'a s drug (like how marijuana is legally a "narcotic" even though that's not at all what it actually is). And since Biopharmaceuticals are medical drugs produced using biotechnology, I think I've adequately covered my bases -- though you had me scared there for a minute.
-Clio
Karma: Bad (mostly from not giving a fuck)
Blog: http://clintjcl.wordpress.com
Name five activities with no possible plausible effect on interstate commerce? None, when you can't even grow food in your garden without it being regulated by the federal government. I mean, I could have sex with my wife and they'd claim it should be regulated because I could have patronized a whore in the next state instead.
Gamingmuseum.com: Give your 3D accelerator a rest.
Glenn Beck's "theblaze.com" is your sole source for this front page post? Thanks slashdot.
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.
A feeling of having made the same mistake before: Deja Foobar
A modicum of facts [wikipedia.org]
A salute you for the diction of your hypertext.
Ceci n'est pas un sig.
It's not commerce if you grow your own wheat and feed it to your livestock.
Oh, wait. Facepalm. http://en.wikipedia.org/wiki/Wickard_v._Filburn
I would love to have a government that stopped thinking so highly of itself.
How about if I clone myself?
Lettem try to arrest me/us I'll/We'll fight on beaches, landing grounds, in fields, in streets and on the hills. I/We shall never surrender!
A feeling of having made the same mistake before: Deja Foobar
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.
Like it or not, this WWII rationing decision is the cornerstone to the present interpertation for interstate commerece.
The pot laws, the laws that limit automatic weapons and clip sizes trace back here - so its not going away.
The only way to get this overturned is to get a Constitutional Amendment. With language like:
Be it the Supreme Court has their head up thine asses when they feltgrowing your own grain on your own property effected interstate commerce and the Congress can't seem to extract it, it is up to the citizens to declare:
Stuff done in the state borders that never leaves the State doesn't effect interstate commerce. And that goes double for that plant growing in yor closet.
Therefore: Go pound sand federalies.
(I'm sure someone else can clean up the verbage. Then all someone has to do is form a 509 (is it 509?) corp to take in donations along with a SuperPAC to get in money and hand it out to various ppl to push the amendment adjenda. Potheads and banna clip advocates united!)
Why thank you! They say it's not the size of your diction, but how you use it.
-Clio
Karma: Bad (mostly from not giving a fuck)
Blog: http://clintjcl.wordpress.com
There are politicans whom want a tighter interpretation of the interstate commerce clause. Ron Paul is one such politician. He is in the Republican Primaries right now. Vote for him.
Actually, the FDA does regulate medical procedures. This is to prevent quackery. It's especially relevant with invasive procedures that transfer tissue from one area to another. Not all cell types are harmless in all areas of the body.
Stem cell treatments are something to which I pay close attention (for obvious reasons). There is a lot of evidence that mesenchymal stem cells can promote healing, but that hasn't been proven in humans. There was an clinic in Louisiana called TCA that was doing MSC trials but the FDA shut them down because they were also selling the procedure outside of the study and against the filed protocol. This is no different except the clinic in TFA isn't even bothering with doing real scientific clinical trials. Preclinical animal data is great, but mice ain't men. There is still much work needed to find optimal dosing levels and tease out other potential hazards.
I have something in common with Stephen Hawking...
Mod parent up: Wickard v. Filburn was the start of the ridiculous expansion of commerce clause overreach.
Redundancy is good And also good.
Constitution grants power to Congress grants power to FDA. Supreme Court affirms that this is the correct interpretation of the constitution, and they are the final arbiters. If you disagree, you're the one who is wrong, by definition.
"Who is the Journal of Quantum Physics going to believe?" --Stephen Hawking
It's extracted from the blood of patients. That extract is then transfused into another body part. It is a treatment for a medical condition. The FDA has regulatory authority over other blood components - plasma, platelets, and whole blood - so why are stem cells in that same blood magically exempted when no other individual fractions of blood are?
Honest question, because this case seems to be much ado about nothing. We can CERTAINLY discuss whether the FDA *should* - as a matter of principle - have the broad authority it's given, but I don't see how this case represents any sort of broad expansion of powers by the FDA - they're asserting that they have the power to regulate this treatment. Given the information in the link you provided, and the simple fact that they oversee & regulate every other use of whole or fractional blood, I'm not sure how you reach the conclusion that the stem cells in that blood belong to some exempt category of blood components.
(As far as the semantic quibble about "narcotic," the Federal code defines the term as it's used. It may not be a 'medically exact' use of the term, but it is defined pretty clearly in the law, where it says "the term narcotic drug is defined as...:")
That's a really bad argument. The Supreme Court can be and is regularly wrong. Their word may be law, but that does not make their work right and everyone else wrong. Big difference.
It doesn't hurt to be nice.
While you may have a point, if I'm allowed to participate in a demolition derby, jump out of an airplane, go skiing down dangerous hills, or drive down gravel roads in a mountain park -- then it seems that morally, I have the right to take risk -- even deadly risk -- of doing something, if I choose to do so. Strange how that right disappears into thin air when expensive medical technology gets involved. The mysticism behind the knowledge of what is safe and isn't safe has been slowly disappearing as more and more information is released publicly, online, where everyone can investigate it themselves. The idea that people are taking risks they aren't aware of becomes more disingenuous with each passing day of the information revolution. But the idea that people are not allowed to take certain risks, unless the government says they can -- is a bit of a joke. This isn't snake oil.
-Clio
Karma: Bad (mostly from not giving a fuck)
Blog: http://clintjcl.wordpress.com
I know there's something in there about regulating something between the States.
What could it be?
Oh yeah, the Commerce Clause. Article I, Section 8.
And do you really want your medical devices and/or pharmaceuticals to be manufactured in the state with the lowest level of safety regulation?
--AC
By the same interpretation, said Commerce Clause grants absolute power over everything. So why pretend the people have rights?
Commerce clause, as I'm sure you know.
Now please explain for us how a return to the pre-FDA muckraker's paradise of food & drug safety is in any way a positive argument for the abolition of the FDA? Or perhaps you meant to say that the FDA should have some regulatory authority, but you disagree with specific regulatory decisions or powers that it's been granted?
The development of Federal power following the creation of the United States is best understood by looking at each constitutional amendment and constitutional case in its historical context. Important cases under the Commerce Clause are no exception. Wikipedia has a great article on this: "http://en.wikipedia.org/wiki/Commerce_clause#New_Deal" . Specifically, the headings "Early Years", "Dormant Commerce Clause", "New Deal", and those that follow.
One case that was particularly difficult for me was Wickard v. Filburn (1942) where the court upheld a New Deal law which mandated that farmers could not grow crops beyond a certain amount on their own land for their own consumption because the EFFECT of consuming their own produce was that farmers would NOT purchase products in interstate commerce and this, was held to have an effect upon interstate commerce such that congress could regulate such production of food for personal consumption.
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.
When Fascism comes to America, it will call itself Anti-Fascism, and tell you to give up your guns.
The Commerce Clause seems to be the wild card of the Constitution which allows the government to justify any law it pleases regardless of the tenuous relationship to actual interstate commerce. I'm surprised that the Commerce Clause has not yet been used to justify the Patriot Act in some twisted way.
How odd it is that today it seems odd to let people have the freedom to make a decision for themselves,
Being able to make a decision requires an ability to understand the facts behind it. Most people today can't understand how to make change without the cash register telling them, much less understand the hazards of introducing blood extracts into various other parts of the body.
- then it seems that morally, I have the right to take risk -- even deadly risk -- of doing something, if I choose to do so.
The difference is that you don't have a licensed expert telling you that you ought to do those things, and when you go to a doctor you do. You don't have a parachuting instructor telling you that you'll die if you don't go up and jump out of a plane. You also have a bit more intuitive insight into the dangers of gravity and being hit by another car than you do over what might happen if some odd bits of cells are injected into various parts of your body. Now, maybe you are a biology major and do understand it, but most people aren't and don't.
You want an example? Most people think that antibiotics are the best solution to whatever ails them. Any antibiotic. Give me something, doctor, for this cold. Cipro is good! Try explaining the concept of adaptation and resistance, and then explain that some antibiotics don't work at all on some infections because the bug you have has never been susceptible to that antibiotic because it doesn't have the metabolic pathway that the antibiotic interferes with to begin with.
It's simple. People say "I hurt. You are the doctor, fix it." They should be able to trust that someone somewhere has determined that what the doctor tells you to do will actually do something other than convert your money into his pocket.
I suppose this means that now I will need FDA approval before inserting sperm into a womans body?
The problem is *why* they claim that power. Specifically, the fact that the process uses imported medical equipment, and therefore everything done with that equipment can be regulated by the Interstate Commerce Clause. It's like saying because home-grown wheat that never leaves the farm means you don't have to buy wheat off the open market, they can regulate that too... oh wait, they've already said they can do that. BTW, this sort of bullshit is why I oh so badly want states to have their constitutionally granted rights back.
"None can love freedom heartily, but good men; the rest love not freedom, but license." --John Milton
You have a right to do as you wish to yourself, but not to others. If you wish to offer a medical service, you have a duty to prove it's safe and effective. Deregulation allowed a huge loophole called "supplements" and people are getting scammed at best and injured at worst (especially when the supplements interact with prescriptions because they didn't tell the doctor "because they are natural"). This loophole is being closed too.
Read some history of the quackery before the FDA and the cost in suffering and lives.
I have something in common with Stephen Hawking...
I can understand if you're a die-hard states' rights advocate, but for everyone else, what's the big deal? I would say that, in general, I put a lot more trust in the FDA -- as much as it may be influenced by politics and money -- than I put in whatever backward regulation agency that may or may not exist in the state of Colorado. I am sure the state-level agency can be influenced much more easily than a federal agency.
When people's lives are at risk, and potentially on the dime of our insurance premiums (even if just for complications), I want to make sure we're doing the best we can of it. At this point, like it or not, it's probably the FDA. They've made some bonehead decisions, but they've also done good things, and I think that in general, we're better off having the FDA than having a hodge-podge of state agencies with different rules.
I'm not really sure I understand the point of states anymore. They made a lot of sense when the country was created, but they make a lot less sense now. I'd rather see a political system where you could vote for representatives-at-large, and the top 435 or 100 get to go to Washington.
"That's quite a diction, but it's not as nice as your dad's."
Ceci n'est pas un sig.
2) "The difference is that you don't have a licensed expert telling you that you ought to do those things, and when you go to a doctor you do." Does the article state that? Often when you need to get a treatment from the *single* place that can give it to you, you are referred to by *another* doctor. If your whole argument hinges on the concept that this specific doctor "made" the people get the treatment by recommending, then I don't readily accept it. Whether a service should be regulated should not be a function of whether the person providing it recommended it or not. That would also seem to imply that you can do whatever you want as long as you don't recommend it. I mean, it works both ways, right? ;)
3) Antibiotic resistance hardly seems a relevant paradigm.
This is joint pain. People in pain. Their lives made worse. Them wanting to do something, and having exhausted so many alternatives that they've now only found one person to help them -- until the government stopped them from doing so by protecting them from their own desires, meanwhile being so slow to approve new therapies, which is great for the insurance companies that do not have to cover such things, who I am sure do not have their fingers involved in this in any way ;)
This isn't a doctor saying "you're going to die if you don't do this". And don't use stupid people as an excuse to take away the rights of the non-stupid. That's not how societies should work.
-Clio
Karma: Bad (mostly from not giving a fuck)
Blog: http://clintjcl.wordpress.com
And it works. The FDA managed to force the Regenexx stem cell culturing labs overseas, but they are still able to perform same day treatments in CO. It's scary that the FDA may have the ability to stop us from utilizing our own cells to heal, and force us into the death throws of FDA approved drugs to treat arthritis symptoms, and not arthritis itself. The FDA would be able to regulate every aspect of biological life if this passes.
You live in a police state. Film at 11.
From the Article, that excerpt seems to be the "Association for Natural Health's" contention that the FDA is just waltzing in and saying "HA HA WE OWN YOUR BODY LOL." That's not the case. You could educate yourself by reading the actual motion for summary judgement here, and see the actual wording of the claims.
The defendants are claiming that their use of the stem cell material constitutes the "practice of medicine" (outside the jurisdiction of the FDA), but they are absolutely extracting and processing blood then re-introducing that extracted material into the body elsewhere as a treatment for a medical condition involving bone and joint pain. This is a therapeutic technique by any stretch of the imagination, and as such the regulation of oversight of that therapeutic technique ARE subject to FDA regulation.
Given that it's a legal brief, the interstate commerce aspect is included as one of SEVERAL points supporting the motion for a summary judgement. It is one of the flimsiest, but the ANH has decided not to address the much stronger claims, and focus on the flimsy ones. This is not a case of FDA over-regulation, this is a case of selective quoting and sensationalistic whinging by a - by all appearances - rabidly anti-FDA "Natural Health" advocacy group. That the FDA asserts its authority to regulate and oversee a treatment technique which uses blood products re-injected into the human body, and which claims to successfully treat / cure specific kinds of joint and bone pain should not be a surprise to anybody who hasn't been asleep for the last 20 years.
1) The internet, which makes researching and verifying information much easier. Why, there are even people who disagree on things, so you can read several viewpoints of $WHATEVER, without having a central authority tell you exactly what is and is not.
2) Science has come a lot farther now, so that there are actual, valid treatments for many ailments, and thus less people with incurable illnessess hopelessly looking for cures that do not exist. (And can now be verified as quackery via point #1.)
3) Regardless of per-capita levels of sickness, there is a much higher population now. Many more total people, and thus many more sick people. But still only one government. So the equation of people saved from quackery (which happens less now, and not just because of the FDA) versus people hurt by failure to approve treatments (which is always going to be at record highs as long as the population goes up and major ailments are not completely cured).
The same decision based on the same factors 100 years apart results in a completely different impact to human suffering AND freedom.
-Clio
Karma: Bad (mostly from not giving a fuck)
Blog: http://clintjcl.wordpress.com
(1) amateur radio signals. by international and national law, no commerce can be conducted on-air by hams.
(2) consensual traditional sex of the "free like beer" variety.
(3) nose picking.
(4) laughing at bureaucrats over any medium, or none except free speech in public air.
(5) Cowboy Neal.
if this is supposed to be a new economy, how come they still want my old fashioned money?
how the fuck can a neurotransmitter be illegal? that makes everyone on earth a criminal, it's totally insane!
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.
Masturbation
If anything, the Internet makes quackery much easier. Trust me that you do not want to go down that road with me. Since 2008 I have been dealing with that issue every day, 365 per year. You really think that people who can barely understand a VCR can make intelligent decisions regarding something as infinitely more complicated as medicine? The empirical evidence says otherwise.
I have something in common with Stephen Hawking...
So if somebody is too stupid to do something, nobody gets to do it. God help us all when even smarter people like you want to drag us down to their level.
-Clio
Karma: Bad (mostly from not giving a fuck)
Blog: http://clintjcl.wordpress.com
The line is easy: anything that can impact someone else.
This is about someone selling modern snake oil, and raing a fit. It's the same ol' thing quacks have been doing forever.
"This is joint pain. People in pain. Their lives made worse" /alternative' health items.
and people take advantage of that. The lie, the cheat, and they will bilk you dry and you might get a placebo effect.And their victim will have no recourse. We see this over and over again with a variety of
The when people see other people doing it, they assume it's legit, even when it is.
They are desperate and glomming on to anything. There is a reason we have an FDA. You might want to look into that.
" which is great for the insurance companies that do not have to cover such things,"
Except, you know, this would SAVE THEM MONEY.
The Kruger Dunning explains most post on
Actually, no. The Supreme court doesn't have a doctrine of SCOTUS infallibility, you're thinking of the Pope.
They can be and are wrong.
Sure, the FDA can regulate the device's movement across state lines. However, once the device reaches it's destination, their power over it is done.
I mean, I've known about this therapy for a long time. I never knew it involved stem cells, or maybe this is a new version that also cultivates those -- but it sounds exactly like platelet replacement therapy (if i can remember the name), something I've been investigating for my chronic foot pain. Not able to stand up more than 10 minutes, burning sensation when I sit ... 24 hours, 5 years now. Because I ran away from mosquitoes on the beach one night. This isn't a witch doctor selling snake oil, this is a doctor with a degree, a license, performing a scientifically accepted treatment. How would disinformation on the internet make that possible again? Maybe a fake diploma mill degree, but how's he going to pay for his medical center if he can't really treat people? How would the lawsuits not show up in public record? How would there not be a bunch of negative Yelp reviews if this doctor was really hurting people? And if what you said was true - then why don't they let people with terminal illnesses who are already dying use drugs that have already passed stage 1 trials? The government appealed and took that right away in 2006 (?). You really think this is about an equation of harm vs harm? That's the excuse. I feel you've been duped. But you also seem to have some of your own anecdotal experience to help clarify your judgment further. However, I feel like you are maybe mis-equating this situation to worse situations you've seen, when in fact all situations are nuanced, and this is not the same as those.
-Clio
Karma: Bad (mostly from not giving a fuck)
Blog: http://clintjcl.wordpress.com
wuddevz
I have something in common with Stephen Hawking...
Bullshit.
The internet is fulll of wrong information and lies regarding medical procedure. Expecting someone to wade through that is unreasonable. Expecting them to go to pubmed and wade through studies is unreasonable, and expecting them to even know what a good study lloks like is unreasonable.
We are in an age of information, not an age of only good information.
People need to be an expert to determine which persons opinion is actual valid.
While the access to data has changes, people haven't.
2) This statement is counter to all the actual facts. Right now there are quacks lying about basic medicine. Since people do not know better, the assume it's true. thousands and thousand of them. There are people they won't vaccinate there children because a playboy centerfold who got famous for picking her nose online tells them they are bad; even when the experts point to mountains of data that show otherwise. CHILDREN ARE DYING because of this. In a world where that happens, how can you expect people to make a good and informed decisions based on internet searches? People still listen to demagogue unquestioningly; see Oprah
3) "which happens less now, and not just because of the FDA"
False. that premise is not correct at all.
" versus people hurt by failure to approve treatments"
a - it's not comparable.
b - You have some weird view that good treatments aren't being approved. I'm not sure what evidence you actually base this on.
You're entire premise flies in the faces of every piece of available evidence in this matter. SO, shut the fuck up.
The Kruger Dunning explains most post on
No. Transportation become easier is why everything applies to the Commerce Clause; as intended.
The Kruger Dunning explains most post on
He is probably doing everything right and performing a useful service. From my cruising the site last night (from a question on Quora) it seems legit. The conditions treated are quite limited, unlike most quack sites.
The problem is that he has a duty to prove himself by doing the required trials. He apparently can't be bothered with that. Sorry, but the rules are in place for a reason. For every legit doctor like we assume he is there are hundreds selling snake oil.
I have something in common with Stephen Hawking...
I made a better comment after that one ;)
-Clio
Karma: Bad (mostly from not giving a fuck)
Blog: http://clintjcl.wordpress.com
The FDAs power even over actual drugs is limited. For example, they can approve drugs or not and they can regulate the marketing of those drugs by the manufacturer. However, they CANNOT regulate when or for what a doctor prescribes those drugs (known as off-label prescriptions) nor can the regulate what doctors say to each other about the drugs as long as they're acting as 3rd parties (not employed by the manufacturer to market the drugs).
As for 'narcotic', their inability to use the term even vaguely correctly just FILLS me with confidence in their ability to make judgements about the medical value of some drugs.
My assumption is also that snake oil is still sold with the FDA -- just like murderers still murder with the police, and even with gun control -- but that with so many legitimate treatments out there that weren't out there 20, 50, and 100 years ago, that it's much less of a problem than it ever was.
My assumption is also that legitimate people are being thwarted from legitimate therapies (also reminds me of gun control in that respect) using the boogeyman of snake oil tactics that simply cannot be effective as they were 50 or 100 yeras ago (Wonder if there's any consistently tracked Justice Department statistics about this sort of thing? Too bad that would probably say more about enforcement levels than cirme levels.).
Basically, smart people are kept from doing as they please because of the actions of stupid people. (Also reminds me of the drug war in that respect.)
Metaphorically, there's a difference between a guard rail protecting you from the bad, and a barbed wire fence keeping you from ever committing any danger you might want to. Unfortunately, respect for rule of law means less and less as the law becomes more and more of an authoritarian, bureaucratic asshole.
And again, if it's truly about harm, why aren't people already slated to die imminently allowed to participate in non-approved drugs that have passed stage 1 trials? What are they being protected from -- dying faster? I tend to think the insurance companies want new treatments treated as rare and as late as possible; gives them more times to pedal actual pharmaceutical drugs, or deny making a payout. And in this specific case, no companies cover it. So the people are intelligent enough to be able to afford to pay for this out of pocket. They aren't paupers tricked by someone lying to them in an information vacuum; this isn't 1912.
-Clio
Karma: Bad (mostly from not giving a fuck)
Blog: http://clintjcl.wordpress.com
Exactly. I am all for the FDA regulating the truth in marketing/advertising of drugs as well as making sure the quality control is adequate. I even support them acting in an advisory capacity on the safety, efficacy, and appropriate use of a drug, but ONLY in an advisory capacity. I could even go so far as to allow them to insist that a manufacturer and practitioner inform the patient of a drug's FDA status (approved, approved for another purpose, disapproved or not evaluated). But ultimately, if I choose to use a drug they don't approve of with or without consulting a doctor, that's my right.
Yeah, I'll be over here holding my breath....
No worries.
FYI, here is the state of the art in MSC studies. Granted it's neurological which is my particular focus, but it's still applicable.
I have something in common with Stephen Hawking...
See you at the black market! ;)
-Clio
Karma: Bad (mostly from not giving a fuck)
Blog: http://clintjcl.wordpress.com
In other words, the government can keep me from having sex with my wife. After all, by having sex with her I am not seeking inter-state sex "services", and therefore affecting the sex trade.
Very cool! I mean, once it's actually used on people ;)
-Clio
Karma: Bad (mostly from not giving a fuck)
Blog: http://clintjcl.wordpress.com
1) By your logic, because I'm not a trained electrician, I shouldn't be allowed to work on the wiring in my house. Where do you draw the line? "I know it when I see it"?
Incorrect. By my logic, you aren't allowed to work on OTHER PEOPLE'S houses for money.
"The difference is that you don't have a licensed expert telling you that you ought to do those things, and when you go to a doctor you do." Does the article state that?
The article also doesn't state that the sky is blue and ice is frozen water.
3) Antibiotic resistance hardly seems a relevant paradigm.
It demonstrates that most people have no understanding of how medicine or medical things work, so need to be able to trust the provider to be correct and accurate. I could have used airline pilot as another example. If you want to go up all by yourself in a small plane, the rules are VERY much different than if you want to be paid to take two hundred souls up on a commercial flight. Most of those people would have no way of judging your flying abilities before risking their lives on your skill. And most of them would have no way of judging your decision to fly above certain altitudes. That's why there are rules that tell pilots how low they can fly. According to you, there should be no rules and everyone on board should just trust that the pilot is making good decisions on his own. The only problem with that, most FAA regulations are there because someone demonstrated that pilots don't always make the correct decisions and need some limits. How dare the FAA put limits on me because some stupid people showed they couldn't fly a plane without running into a mountain!
Them wanting to do something, and having exhausted so many alternatives that they've now only found one person to help them --
Did the article tell you that, or are you making it up?
Is it your argument that it is ok to rip people off if they are coming to you as a last resort? That everyone prior to "last resort" can be regulated, but "last resorts" can do whatever they want to you without any danger of recrimination?
>Did the article tell you that, or are you making it up?
Well, I'm assuming if the procedure isn't covered by insurance, and this doctor is the only doctor that is being prosecuted for it, then the people have already tried alternatives for which insurance would pay (and thus have exhausted many alternatives), and that this doctor is the one person to help them (because he is the only one mentioned in the article).
I see I was right to not want to go into antibiotic resistance, as I find your FAA metaphor just as flawed. Nobody's flying anybody into a mountain or endangering 100s of people who don't know the risks. I'm thinking you probably have to give more information than usual about the risks associated with a non-approved procedure. Hell, I can barely get a root canal without having to sign a waver telling me about the risks. We are not in an information vacuum.
-Clio
Karma: Bad (mostly from not giving a fuck)
Blog: http://clintjcl.wordpress.com
So if somebody is too stupid to do something, nobody gets to do it.
Where did you get that one from? The article? Nope.
If you are so smart and understand the process so well, do it to yourself. It should be simple for someone so smart. The FDA won't care. You just can't charge others for doing it to them.
Or was this "nobody can do it" part of that old joke, "nobody can do it, and I'm nobody...".
The FDA has national regulatory authority, just like any Federal institution. That scope originally required that something be directly involved in an interstate transaction; they had no authority to regulate behavior which did not have an interstate component.
This procedure is in no way directly an interstate transaction. It would be the same as if the Federal government claimed authority to regulate the construction of every structure in the USA simply because some of the materials used to build any structure at one point crossed state lines (or because the construction impacted interstate commerce by not buying anything from out-of-state).
Of course, the above is nothing but theory. Actual current practice is the exact opposite though, and under current precedent those who run the Federal government would certainly believe they had the authority to regulate every structure ever built (or ever to be built) within the USA.
See, I prefer that people be allowed to trust who they want. The alternative that you stated could be reduced to "people less smart can't ask people more smart to do the things they {the smart ones} know how to do, unless the government says they are smart enough."
Reminds me of back-alley abortionists - we can either let a doctor with a license do this, or we can have Inject-Fix-A-Flat-style parties where people do this on the side. At least this is valid science, but I'd much rather not drive people underground when getting what they want.
-Clio
Karma: Bad (mostly from not giving a fuck)
Blog: http://clintjcl.wordpress.com
To be fair, the term "narcotic" is similar in use to the term "assault weapon," in that it is frequently conflated with "opiate" in the way that the latter is conflated with "assault rifle."
A narcotic is anything which has psychoactive effects. It is not a useful term aside from compliance with regulations dealing with drugs so classified.
If you don't like the way the Federal Government manages power, you should move to Oklahoma and deal with the shitkickers there.
More than half the state are Jesus crazed lunatics waiting for the rapture while trying to start their own Taliban like theocracy and living in fear that the communists are going to come over and take their Bibles away.
Even a large number of what passes for moderate, that's slightly to the right of center, considers everything but Christianity, and that's their definition of Christianity whether Catholics qualify or not varies because Catholics pray to the Saints, to be Satanism.
How does a dead person sue someone anyway?
Oh, now I know you're making things up. Who said anything about dead people?
I'm saying if you're going to die in a few months,
I thought you were talking about people in chronic pain. Now you're talking about people you know are going to die in a few months. Was THIS in the article anywhere?
Well, I'm assuming
Yes, you are. You should read the actual brief. It's fascinating.
and that this doctor is the one person to help them
Then let him follow the federal law regarding the manufacture and use of drugs and he can. The FDA didn't just swoop in and say "stop that", they were there on previous visits and told them what was being done wrong. They could have complied. Read the brief. It's fascinating.
And you are assuming that this procedure is anything more than snake oil. You are assuming quite a lot.
Nobody's flying anybody into a mountain or endangering 100s of people who don't know the risks.
So you are actually claiming that every person who gets on an airplane knows exactly what the correct altitude to fly a specific route is and accepts the risks of the decision the pilot makes? Every person on a commercial airliner knows the risks of flying five miles off the centerline of an airway, or 500 feet high or low, when they get on board an aircraft. That they know the risks of exceeding the ATP standards for instrument approaches and accept those risks freely? That the rules and laws regarding those actions are unnecessary because the passengers know the risks and accept them all? And that there is some mechanism in place for passengers who do not agree with a decision of the pilot during the flight to rescind his authorization to act on their behalf?
Have you ever flown on an airliner? Describe for me the "protected zone" for an ILS approach and what, if any, are the hazards that can exist even within that protected area. You need to know that if you are going to evaluate and agree to the risks in any educated manner. How about describing the reason for the "ILS HOLD" lines at the airport, the technical details regarding the area, and what effects there could be were you to enter that area. Or, you could accept that the FAA has issued rules regarding required and minium altitudes and procedures to be used that minimize the risk, and that the FAA has tested the pilot for his understanding of and ability to adhere to those rules before allowing him to pilot the aircraft.
In addition, the FAA has rules regarding the manufacture and use of nuts and bolts and rivets and all kinds of hardware that go into an airplane. According to you, people who get on an airplane know and accept the risks of the use of unapproved hardware and laws are not required. Guess what? Bogus aircraft hardware IS an issue and does cause crashes. A bolt made from cheap steel doesn't hold as well as the proper one and can come apart in midair. You don't just pull over and stop when your wing falls off while flying, like you can maybe pull to the side of the road in your car. The people who get on that airplane have no knowledge of the standards or that the aircraft is safe, sans those regulations, and even then mistakes happen. They're all "stupid", and they deserve protection from cut-rate fly-by-night operations. Just like the people who go to a doctor expect him to be certified and knowledgable, and to be using approved medications where the risks are, if not absent, reasonably well known, and are produced according to health and safety standards that prevent avoidable serious injury or death. (Read the brief. The defendants admitted that microbacterial contamination of the process was likely but didn't take sufficient measures to prevent it.)
Hell, I can barely get a root canal without having to sign a waver telling me about the risks.
You just
Back when I was in the military, it was already being done to speed up climatization of troops.
Blood was drawn from soldiers, and the hemoglobin / red blood cells were extracted and frozen months in advance to troops being deployed to different climates.
Once the troops arrived, they were given their own blood parts back increasing their hemoglobin / red blood cell counts in order to speed up how quickly they adapted to things like temperature and elevation changes.
I believe that athletes and other people have done the same thing when they desired to adapt more quickly to a new area.
So really, this isn't a new process, just doing it with different materials. And since the FDA didn't jump all over the one as commerce, they shouldn't be allowed (ie precedent set already that it wasn't commerce) to jump on this one.
Sure, the FDA can regulate the device's movement across state lines. However, once the device reaches it's destination, their power over it is done.
So, you're saying, once the oxycontin package hits the pharmacist's shelves, the FDA no longer has any jurisdiction to regulate it? That once the 50 pound barrel of oxycontin powder reaches the formulary, the FDA no longer has any regulatory authority over how it is used or mixed with other "devices", as long as it doesn't go back out of state?
Interesting theory. Do you have a newsletter I can subscribe to?
Stem cell treatments are something to which I pay close attention (for obvious reasons).
I keep looking at your handle trying to figure out what the obvious reason might be... I got nothing.
Try clicking my sig.
I have something in common with Stephen Hawking...
I am quite capable (or was...) of driving at 100+MPH but most aren't so we have speed limits quite a bit lower.
I have something in common with Stephen Hawking...
That's how it is SUPPOSED to be anyway. The Sophists in the supreme court have failed utterly to uphold that, but that's how it is supposed to work.
If the FDA would like to put together model laws for state legislatures to consider, they may.
From Wikipedia, on Gonzales v. Raich
"If the Federal Government can regulate growing a half-dozen cannabis plants for personal consumption (not because it is interstate commerce, but because it is inextricably bound up with interstate commerce), then Congress' Article I powers -- as expanded by the Necessary and Proper Clause -- have no meaningful limits. Whether Congress aims at the possession of drugs, guns, or any number of other items, it may continue to "appropria[te] state police powers under the guise of regulating commerce."
and further:
"If the majority is to be taken seriously, the Federal Government may now regulate quilting bees, clothes drives, and potluck suppers throughout the 50 States. This makes a mockery of Madison's assurance to the people of New York that the "powers delegated" to the Federal Government are "few and defined", while those of the States are "numerous and indefinite." "
But Elixir Sulfanilamide was a miracle drug! The FDA got all in a fit because of little naming issue. Turns out that it wasn't technically an elixir since it didn't have an alcohol base. Diethylene glycol tastes much better than ethanol anyway.
Would be an apt metaphor if me getting a stem cell treatment threatened the lives of people around me, but it doesn't.
-Clio
Karma: Bad (mostly from not giving a fuck)
Blog: http://clintjcl.wordpress.com
The point was about the lowest common denominator.
I have something in common with Stephen Hawking...
the federal government is so out of whack, big, complicated, and over-powered. initially, this why i cheered the tea party and a gushing new wave of conservatism. as i've watched the haggling about the budget over the past year, i realized what a mistake it is for us to support conservatives any more. basically, we have teenagers (liberals) doing and spending whatever they want. then we have parents/adults (conservatives) reigning them in and putting them in check every so often. another analogy, we have reckless users (liberals) doing whatever they want with 'the machine'. when the machine slows down or looks like it's going to break down, we send in the maintenance crew (conservatives).
i think the only way to fix all of this mess is to let it actually, completely break. let it bankrupt itself. vote for the stupidest, most 'spend money like a drunken sailor' candidate that you find. when it really does go KA-BLOOWY, then we'll be in a position to fix this mess.
OK, so this is an obvious malinterpretation of law, but I'm surprised that no one has mentioned the potential medical misdirection here. Hematopoietic stem cells are not like embryonic stem cells that can theoretically be engineered to grow into any type of cell -- they can only create blood cells, not tissue, bone, etc.
This is disturbingly reminiscent of a story I read here about people who died from having HSCs injected into their kidneys by snake-oil doctors.
And if you go scan, or - and I know this is a stretch here on /. - read the actual motion for summary dismissal, you see that the Commerce Clause argument is actually a very small (and probably the flimsiest) part of their argument. It is cited by the ANH specifically because they know it'll draw 10 kinds of tin foil hat outrage.
That this procedure is a therapeutic treatment, that it is being marketed as a beneficial treatment for certain conditions involving joint and bone pain, and that it is being marketed with such claims without any certification that the claims are accurate or even remotely true (and that none of these points are disputed other than the defendant company saying that their marketing claims somehow make this treatment a "practice of medicine" and should thus be exempted from FDA oversight) would all seem to be very compelling and legitimate reasons for the FDA to take a role in overseeing & regulating this treatment.
The problem is *why* they claim that power. Irrelevant, they have the power, how they got it is ancient history. The question is, are they using it wisely? - If you think not, then why not?
this sort of bullshit is why I oh so badly want states to have their constitutionally granted rights back
But speaking of history; the ideological absurdity that shifting power from one group to many smaller groups will somehow result in unicorns farting rainbows flies in the face of 10,000yrs of human history. What it generally results in, is a collapse of infrastructure and an abundance of local warlords.
And did you exchange a walk on part in the war for a lead role in a cage? - Pink Floyd.
Opps, fucked up the quote tags.
And did you exchange a walk on part in the war for a lead role in a cage? - Pink Floyd.
"I regret to say that we of the FBI are powerless to act in cases of oral-genital intimacy, unless it has in some way obstructed interstate commerce."
it would have been Armageddon in liberal land....
The FDA apparently thinks human organs as drugs, and surgical operations involving needles as non-surgical operations. Brilliant!
Not directed toward your quote........, but the FDA does jack shit too regulate ANYTHING, 3 out of 5 drugs """"FDA approved"""" get recalled of the market!! The only drugs that get ""noticed"" are the ones the asshole media reports on.. Why the fuck is the even news????? The FDA is complete bullshit, so why do we have to read these """FDA"" approved drugs on slashdot? Come on man!!!! You report this, months later, even a few years later you report how it was pulled of the market. And then act dumb founded as to why?
Unless it was a direct cure for something, "" oh lord, god forbid there be a cure for something""" Usually directed towards gene therapy, oh good lord, not the gene therapy" !!!!!!!!!!!!! Another branch of government in which tax payers money is wasted!!!!!!!
They do nothing to oversee the testing why in the fuck would you trust them to approve anything!!!!!!!!! Same SHIT the FCC, and FAA are at fault for.. Might as well say this shit before Slashdot follows Twitters, and Google's examples of censorship!!!!!!!!!!! Sorry for the dramatics but this FDA bullshit is just that ""bullshit""!!!
Unreal...
Actually, no. The Supreme court doesn't have a doctrine of SCOTUS infallibility, you're thinking of the Pope.
They can be and are wrong.
And have admitted that previous rulings were wrong when they later overturned them, which of course makes efforts to get Supreme Court nominees to pledge fealty to stare decisis wrong. Some of the same people who are today strong proponents of Supreme Court Justices honoring stare decisis also praise Supreme Court judgements which overturned previous Court rulings.
The truth is that all men having power ought to be mistrusted. James Madison
So, because I buy clothes which were manufactured in another state, the government has the authority to regulate what activities I do while wearing them?
The truth is that all men having power ought to be mistrusted. James Madison
If the treatment is done in Colorado, on people in Colorado, with materials that have been put together in the way that the FDA has a problem with in Colorado, why is this not a matter for the state of Colorado to regulate?
The truth is that all men having power ought to be mistrusted. James Madison
You keep minimizing the importance of the Commerce Clause argument, yet without that argument Congress does not have the authority to give the FDA the power to regulate this activity. Or to put it another way, the only way that the FDA has the power to regulate this company's activity is if the Commerce Clause gives Congress the authority to pass laws regulating that activity. So, if this company's activity falls under the Commerce Clause provision, then, yes the FDA has the authority to regulate it. On the other hand, if this company's activity is purely intrastate then Congress does not have the authority to pass any laws which effect their activity. The two relevant recent Supreme Court rulings are Gonzalez v. Raich and United States v. Lopez. If the courts decide this more closely follows Gonzalez v. Raich, they will find in favor of the FDA. On the other hand, if they decide this more closely tracks with United States v. Lopez, they will find against the FDA.
The truth is that all men having power ought to be mistrusted. James Madison
That's a really bad argument. The Supreme Court can be and is regularly wrong. Their word may be law, but that does not make their work right and everyone else wrong. Big difference.
I think the other author's point was that the Supreme Court is not final because they are right, they are right because they are final.
In what way is marketing your unlicensed medical treatment to people across the nation, encouraging them to cross state lines and spend their money in Colorado on said unlicensed treatment... NOT interstate commerce?
Also, from the FAQ section of their web site: "Are you licensed by the state?"
Oops... looks like they just conceded that they're performing their treatment protocols on people who've crossed state lines from New York, at the very least - otherwise why would NY tell them they needed licensure, and why would they apply for a license from NY? If you cross from one state to another to perform a transaction, you're engaging in interstate commerce.
Also, it's generally accepted by the courts that the federal government can also regulate commerce *within* a state when it may impact interstate movement of goods and services.
Also, this is a medical treatment, whose efficacy claims are subject to FDA oversight and regulation.
But they aren't final. Next year's Supreme Court can overrule them.
It doesn't hurt to be nice.