Medicine, stem cells, the FDA, and the Commerce Clause

[zahc]

http://singularityhub.com/2010/03/09/colorado-doctors-skirt-fda-jurisdiction-to-provide-human-stem-cell-therapies-video/

From what I understand, this clinic is attempting to use a stem-cell treatment process that is not FDA approved, because they say that they are only using it in their own clinic, thus, since it stays within the borders of Colorado, the FDA has no  authority to tell them they can't.

The FDA has yet to approve stem cell therapies for general use in medicine, but that hasn’t stopped doctors in Colorado from providing them anyway. Chris Centeno and John Schultz have boldly formed Regenerative Sciences Inc. in Broomfield, Colorado. RSI provides its patients with the Regenexx procedure, an adult stem cell transplant that uses your own cells (autologous) to treat joint injuries and bone damage. There’s no surgery needed. A needle extracts bone marrow, RSI isolates the stem cells and cultures them in your own blood, and then these cells are injected into the area where they are needed. They’ve treated 348+ patients with 800+ injections and show no signs of slowing down. According to RSI’s own surveys, 89% of their knee patients showed marked improvement, as did 75% of their hip patients! Within months some patients can walk or run in ways they haven’t been able to in years. We’ve seen these kinds of results from stem cell treatments before, but only in horses and dogs. That’s because human stem cell therapies like this one aren’t approved by the FDA. How can Centeno and Schultz flaunt the lack of federal approval? They claim that Regenexx is solely used as a part of their medical practice, only within the state of Colorado, and as such is no more regulated by the FDA than it would be by the FAA or the Department of Motor Vehicles.

Very interesting!

[RaspberrySurprise]

Sounds like the same general reasoning that Montana and some other states are using with their intrastate firearms laws. Sadly I have a feeling the Feds are gonna say that they have power over it even though the Constitution says otherwise. They have the most power and guns which means they have the control.

[Brad Johnson]

They have the most power and guns...

Actually, they don't.  "We, the People" do.  It's just that a bunch of "W, the People" have forgotten that tiny tidbit and assume the .gov is the locus of power and control.

Brad

[zxcvbob]

Since it's a surgical procedure rather than a drug (or food additive), I'm not sure the FDA has jurisdiction anyway.

[RevDisk]

Since it's a surgical procedure rather than a drug (or food additive), I'm not sure the FDA has jurisdiction anyway.

Bet you they assert jurisdiction anyways. 

I'll have to see if I can find any peer reviewed papers on this procedure.

[mellestad]

Stem cell injections really do work in many cases.  From what I have read though adult stem cells may not always turn into what they are supposed to turn in to, and if they don't you get another type of cell that grows without control: cancer.

Since the cancer might not show for years and years, the FDA has not been willing to give the treatments the go ahead without very long clinical trials.

Best thing I read about it: In fifty years this guy will either be a hero who fought, 'the man' and scored a victory for fontrier medicine, or he will be a monster who doomed people with an untested treatment that turned out to be highly dangerous because he was greedy and stupid (or reckless).

[Tallpine]

According to RSI’s own surveys, 89% of their knee patients showed marked improvement, as did 75% of their hip patients! Within months some patients can walk or run in ways they haven’t been able to in years.

OMG!  Think of all the orthopedic surgeons and nurses and physical therapists that will be out of work! 

Since the cancer might not show for years and years, the FDA has not been willing to give the treatments the go ahead without very long clinical trials.

Let's say you're 60 years old with bad knees.  So, in maybe twenty years you will get cancer from this treatment.  In the meantime, you can now actually walk and run and climb mountains and ski and bulldog steers 


Stem cell treatment: ask your veternarian 

[sanglant]

yeah but you could really find yourself hurting at 80. man what are these dopes smoking, and where can i get some.

[RevDisk]

yeah but you could really find yourself hurting at 80. man what are these dopes smoking, and where can i get some.

At 80, in my opinion, the statistical few that are still alive will be comparatively hurting anyways. 

Personally, I'd be willing to trade 20 good years from 60-80 (or whatnot) for a bad time at 80+.  Assuming that it's a factor (both that there is a guaranteed heightened risk of cancer after X years and risking that medical science won't advance whatsoever in the course of X years).  Now I'm aware that not everyone agrees.  That's perfectly fine.  But individuals should have the right to make those decisions for themselves. 

Kinda like having a terminal "No kidding, you WILL be dead in six months" situation.  I should be able to a) volunteer for any experimental procedure/drug/whatever I want to (assuming informed consent, etc) and b) should be allowed to be blitzed out of my mind on every painkiller known to man.  Current drug laws regarding the terminally ill, especially in pain management, often range from asinine to "the folks responsible should be detained for crimes against humanity". 

[roo_ster]

The whole embryonic vs adult stem cell controversy is such a ridiculous set-up by the pro-abortion folk, who just want an excuse to conceive babies to be slaughtered on general principle.  Truly, to enshrine the principle of baby/fetus slaughtering as the standard.   

First off, the most (number) and most (promising) therapies are with adult stem cells.

Second, for those potential therapies most likely to be successful with "embryonic" stem cells, there are millions of viable, non-controversial sources of stem cells available each year that harm not a hair on any baby's head: umbilical cords...which are currently disposed of as biohazardous waste.   

I think the best move pro-life folk could make would be to push to harvest all those umbilical cords that currently are incinerated.  Babies & parents get first dibs, but make it easy and routine to donate the umbilical cord to science or experimental clinics that specialized in "embryonic" stem cell therapies.

[sanglant]

At 80, in my opinion, the statistical few that are still alive will be comparatively hurting anyways. 

Personally, I'd be willing to trade 20 good years from 60-80 (or whatnot) for a bad time at 80+.  Assuming that it's a factor (both that there is a guaranteed heightened risk of cancer after X years and risking that medical science won't advance whatsoever in the course of X years).  Now I'm aware that not everyone agrees.  That's perfectly fine.  But individuals should have the right to make those decisions for themselves. 

Kinda like having a terminal "No kidding, you WILL be dead in six months" situation.  I should be able to a) volunteer for any experimental procedure/drug/whatever I want to (assuming informed consent, etc) and b) should be allowed to be blitzed out of my mind on every painkiller known to man.  Current drug laws regarding the terminally ill, especially in pain management, often range from asinine to "the folks responsible should be detained for crimes against humanity". 

that's the horse tallpine killed, and i just had to stomp. well that and the quality of the smoke the libs are managing to find.

[tyme]

The whole embryonic vs adult stem cell controversy is such a ridiculous set-up by the pro-abortion folk, who just want an excuse to conceive babies to be slaughtered on general principle.  Truly, to enshrine the principle of baby/fetus slaughtering as the standard.   

The entire problem is that we do not agree with you that an embryo has rights or a "soul", and by definition if it is an embryo it is not a fetus yet.  Just because you feel strongly about it does not make us "ridiculous" nor do we want an excuse to slaughter anything.

You can rant about it all you want...

Second, for those potential therapies most likely to be successful with "embryonic" stem cells, there are millions of viable, non-controversial sources of stem cells available each year that harm not a hair on any baby's head: umbilical cords...which are currently disposed of as biohazardous waste.   

...but you are not changing any facts.  You might also note that embryos do not have hair to be harmed.

I'm in favor of using all available sources of stem cells.  Embryonic stem cells wouldn't even work AFAIK for these kinds of treatments (in the OP) without immunosuppressants, the whole point being using the patient's own adult stem cells avoids that problem.  However, that doesn't mean that there is no possible future use for embryonic stem cells that won't be able to be satisfied by other stem cell sources.  And for people like me who don't think an embryo has "rights" or a "soul", there is no downside to allowing and funding embryonic stem cell research, if scientists deem it useful.  If they don't think embryo-derived embryonic stem cells are useful, they can always use stem cells from other sources and both you and I will be happy.

You simply don't know if stem cells derived from adults can be reprogrammed to be sufficient for any future medical stem cell therapies.  It may turn out that even umbilical cord derived pluripotent stem cells are not quite the same as embryonic stem cells from a several day old embryo.  That's what we in Baby Killers Anonymous object to: your desire to slam doors when we don't know what's behind them, on the basis of moral and ethical judgments that we don't share.

[Perd Hapley]

The entire problem is that we do not agree with you...Just because you feel strongly about it does not make us "ridiculous"...

You can rant about it all you want...

...but you are not changing any facts.   

...on the basis of moral and ethical judgments that we don't share.

That pretty much sums up my point of view on the recent legitimizing of homosexuality. Folks can say it's right or normal all they want. I have no obligation to play along.

But anyway, the argument fails for Mr. tyme.  The law should default to protecting human lives.  It's that simple. 

[Seenterman]

That pretty much sums up my point of view on the recent legitimizing of homosexuality. Folks can say it's right or normal all they want. I have no obligation to play along.

That's fine, but your not actively trying to stop homosexuals from doing their own thing. I don't understand why its taboo to experiment  / harvest embryonic cells of fetuses that were aborted, there may be conditions / disabilities where it is unfeasible to harvest enough adult stem cells from the patients own body for treatment, that a surplus of embryonic stem cells would be about to cure. Lets try and tread lightly on the abortion issue, this isn't the thread for that.

[Nick1911]

But anyway, the argument fails for Mr. tyme.  The law should default to protecting human lives.  It's that simple. 

To you, maybe.

There are societies where cows are considered sacred.  Doesn't stop me from eating beef, though, because I don't share that system of morality.  It's a frame of reference thing.

Anyway.  abortion hamburgers are murder! 

[tyme]

That pretty much sums up my point of view on the recent legitimizing of homosexuality. Folks can say it's right or normal all they want. I have no obligation to play along.

But anyway, the argument fails for Mr. tyme.  The law should default to protecting human lives.  It's that simple.  

Sure, it is that simple.  Where we disagree is whether an embryo is a "human life" (with its attendant political and legal rights and protections).

[mellestad]

......Where we disagree is whether an embryo is a "human life" (with its attendant political and legal rights and protections).

That is the sticky question isn't it.  The problem is, the side that says life begins at conception and the side that says anything else simply can't reconcile.  There isn't any middle ground, so all either side can do is lobby politicians and try to control the cultural outlook of the next generation.  There is no argument to me made that can convince anyone to switch sides, at least none I have ever heard.

[RevDisk]

That is the sticky question isn't it.  The problem is, the side that says life begins at conception and the side that says anything else simply can't reconcile.  There isn't any middle ground, so all either side can do is lobby politicians and try to control the cultural outlook of the next generation.  There is no argument to me made that can convince anyone to switch sides, at least none I have ever heard.

Well, if life begins at fertilization, you could not PAY me to be a lab tech at an IVF lab.  One dropped petri dish and you're facing manslaughter charges.   

[mellestad]

Well, if life begins at fertilization, you could not PAY me to be a lab tech at an IVF lab.  One dropped petri dish and you're facing manslaughter charges.   

That is an interesting point!

[MicroBalrog]

Even if we agreed (I don't) that life begins at conception, moral issues exist with abortion.

Suppose I woke up with fistful - who is very much a human being and alive, and whose humanity is not in doubt - medically attached to my body. Perhaps fistful suffers from some kind of medical issue which requires him to be attached to my body for nine months to survive. (Such a condition doesn't exist. Though experiment.)

Would it be murder for me to rip out the cords connecting me to fistsful and get off the scene?

[sanglant]

Sure, it is that simple.  Where we disagree is whether an embryo is a "human life" (with its attendant political and legal rights and protections).

not to start an argument but, how about, "once it can live outside the womb, it's a human being." ?

[Tallpine]

not to start an argument but, how about, "once it can live outside the womb, it's a human being." ?

That's a changing definition, as neo-natal care improves 

[mellestad]

That's a changing definition, as neo-natal care improves 

And what happens when we can grow people in a vat?

[RevDisk]

And what happens when we can grow people in a vat?

Dude, who's gonna care because they'll be too busy building Clone Armies.

[mellestad]

Dude, who's gonna care because they'll be too busy building Clone Armies.

True.

Clone rights now!  Clone rights now!