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FDA Wins Right To Regulate Adult Stem-Cell Treatments
ananyo writes "A court decision on 23 July could help to tame the largely unregulated field of adult stem-cell treatments. The US District Court in Washington DC affirmed the right of the Food and Drug Administration (FDA) to regulate therapies made from a patient's own processed stem cells. The case hinged on whether the court agreed with the FDA that such stem cells are drugs. The judge concurred, upholding an injunction brought by the FDA against Regenerative Sciences, based in Broomfield, Colorado. The FDA had ordered Regenerative Sciences to stop offering 'Regenexx', its stem cell treatment for joint pain, in August 2010. As Slashdot has noted before, they are far from the only company offering unproven stem cell therapies."
And just about everyone will be pleased that they won't see an infomercial for these unproven treatments and get swindled because they can't apply critical thinking to their own purchases.
Of course, they will just change the treatment to being labelled as a homeopathic stem cell supplement and the profits will return.
Just remember! Never trust Western Medicine or Big Pharma! Trust us instead.
Since one of the FDA's roles is to check medical treatments for safety and efficience, this is consistent with its mission.
Now it being able to do the job correctly is another matter entirely, regulatory capture seems to be the USA's national sport...
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I think almost everyone is fine with government regulating dangerous unproven medical treatments with potentially horrific side-effects.
"None can love freedom heartily, but good men; the rest love not freedom, but license." --John Milton
Injecting stem cells randomly into the body is probably not a good idea. Stem cells aren't magically fix everything machines. There's a significant risk of cancer if nothing else and I'd be shocked if there weren't other potential issues as well. Why do we have people running around defending hack doctor's rights to inject them on unsuspecting and uninformed patients? And don't say the patients are informed, the research on risks hasn't even been completed yet, how could they possibly be informed of risks that the administering doctor doesn't even know about?
Lets go to an extreme, how would you feel about the FDA telling a doctor that they can't inject stomach acid into a person's blood stream? Other than the risks being more obvious, what's the difference?
This doesn't really sound like a good thing. I understand the desire to want to regulate unproven stem cell therapies. However, if history has shown us anything it is not regulation that they seek, but to stifle the industry entirely. Likely so the large pharma stock holders can hold on to their dividends. Maybe I am understanding this wrong? Anybody with more understanding of the matter, feel free to enlighten me.
I would think there should be government mandated transparency but the government should not decide which drugs we are allowed to take. If you are given all the known facts upfront, you should be able to make your own choice.
The FDA, a government bureaucracy, has "rights"?
Liberty in your lifetime
Trouble is...this isn't the case here.
Most of this type of treatment..is your doctor, taking your own stem cells, isolating them, and then, injecting them back into your problem areas in a concentrated form basically.
Using your own body to treat itself....and now, well, the progress being made across the country will be halted largely, and it will now cost more money, etc.
The issue in the courts there is, that Dr's were arguing that they were using your own body to treat itself, which they are...much like a skin graft..the FDA isn't involved there. The FDA wants its hands in this...and somehow have successfully gotten the courts to say that taking your own cells out...and putting them back in...is a foreign drug being introduced into the body...and in there jurisdiction.
Sad...this one is a battle that should have been won by the doctors, as that it has been showing great progress in many areas....hope this can be appealed and overturned.
Light travels faster than sound. This is why some people appear bright until you hear them speak.........
A number of doctors do think dialysis should be better regulated than it is now, to ensure that patients are getting actually good care following scientifically validated practices. The two options are basically to regulate it as a drug, or as a medical device.
10 PRINT CHR$(205.5+RND(1)); : GOTO 10
So what you're saying is - don't mess with tx.
Quick! I need an ideological purist to tell me what to think about this!
http://www.hoover.org/multimedia/uncommon-knowledge/26936
Here is the excerpt:
ROBINSON: The Food and Drug Administration which regulates everything from the drugs that pharmaceutical companies may put on the market to the ingredients in items we purchase off the grocery store shelves. Let me give you an example- Thalidomide [FRIEDMAN Everybody's favorite example...] Well I may be leading with my chin on this one but I'm going to lead with it anyway. 50's and 60's it is marketed in Europe as a drug to help women get through the nausea that they sometimes experience during pregnancy. The Food and Drug Administration said it had been inadequately tested in the United States and forbade it to be marketed in this country with the result that thousands of children were born with horrible birth defects in Europe to mothers who had used Thalidomide but that didn't happen to American children, because the FDA had intervened and kept that drug off the market. Thank god for the FDA, right?
FRIEDMAN Wrong [ROBINSON Alright, why?] this is a case in which they did save lives, this was a good case, but suppose they are equally slow in adopting a drug which turns out to be very good and beneficial. How would you ever see the lives that are lost because of that? You're an FDA official, you have a question of whether to approve or disapprove a new drug. If you approve it and it turns out to be a bad drug like Thalidomide, you're in the soup, your name is going to be on every front page [ROBINSON cost me my job, I get hauled up to Congress to testify..] right. On the other hand if you disapprove it, but it turns out to be good, well then later on you approve it four or five years later, nobody's going to complain about the fact that you didn't approve it earlier except those greedy pharmaceutical companies that want make profits at the expense of the public, as everybody will say. So the result is that the pressure on the FDA is always to be late in approving. And there's enormous evidence that they have caused more deaths by late approvals than they have saved by early approval.
" If you are given all the known facts upfront, you should be able to make your own choice."
Yet people still start to smoke, tobacco. When learned about how it effects others in the area who shown not to make the choice, they still continue.
Or you have stupid parents who believe some crazy nut job and will not vaccinate their children. In fear of a 0.001% increase of an other illness, while the vaccine will have a 5% chance of saving the child's life.
Given the Fact there will be a charismatic conspiracy nut that will refute the claims, that will attract a big following.
If something is so important that you feel the need to post it on the internet... It probably isn't that important.
From TFA:
The court disagreed on both counts, noting that “the biological characteristics of the cells change during the process”, and that this, together with other factors, means the cells are more than “minimally manipulated”.
Leigh Turner, a bioethicist at the University of Minnesota in Minneapolis, agrees. “It is much too simplistic to think that stem cells are removed from the body and then returned to the body without a ‘manufacturing process’ that includes risk of transmission of communicable diseases,” he says. “Maintaining the FDA’s role as watchdog and regulatory authority is imperative.”
They aren't just taking pieces from one part and injecting them into another. They are taking pieces, modifying them, and then re-injecting them. It's quite possible that a procedure that didn't modify the cells would be fine with the FDA: in fact, TFA mentions that the company in question offers 3 other processes that have much quicker turn-around which the FDA has not taken issue with (they have also not approved them, so we'll see if they decide to tackle them later as well or not).
"None can love freedom heartily, but good men; the rest love not freedom, but license." --John Milton
Shouldn't be that bad? They are taking cells and injecting them where they don't naturally occur. That can have side effects such as cancer. I'm not saying it's not promising but there have been far too many wild claims about it and far too many clinics treating it as some magic cure without any regard for patient safety.
I wonder it Friedman remembers why the FDA was needed in the first place? The FDA *was a response* to an imperfect market. If it's doing what Milton says it's doing, then the FDA is doing exactly what it is supposed to do!
You know that economics as a science is fundamentally flawed when it expects that people are out to serve their best interests.
People are idiots. A person may be smart, but people are stupid and have no idea what is in their best interest. People's rational and irrational fears and impulses can be preyed upon. Marketing is all about making people make *stupid economic choices* with limited and biased information. Economics might actually work if marketing didn't exist to exploit humanity's fundamental frailties. Until then, pardon me if I don't listen to the likes of Friedman when it comes to government policy on this topic. Our must fundamental fear is fear of death. And the FDA exists to prevent that natural fear from being preyed upon by the unscrupulous.
the growth in cynicism and rebellion has not been without cause
You know some doctors that are having amazing results, but can't manage to prove it in a double blind study?
You know some conmen, not doctors.
It's not that bad. You can do it yourself at home.
Get a syringe and remove some blood from yourself. Put it in a bowl. Add some deionized water, but if you don't have that, just use tap water or whatever well water you have around the house. Warm it gently on your stove until it's slightly warm, then place the blood/water mixture into a sealed vessel - if you don't have that use a mountain dew bottle with a good cap on it. Place the vessel into a centrifuge but if you don't have that use a good clothes washer on the spin setting. Remove the blood cells with the same syringe you used earlier if you don't have a clean one. Add some chemicals to seperate the stem cells from the 'regular cells'. If you don't have the real thing crush up some mentos and a pinch of baking soda and mix it in. There will be a thin layer of clear liquid to form on the surface - thos are your stem cells. Inject those cells where it hurts.
If you are given all the known facts upfront, you should be able to make your own choice.
You need only apply this line of reasoning to other endeavors to realize it simply is not true.
Many, if not most people can not possibly make a rational decision even when presented with "all the known facts" simply because they can't
interpret the research, due to inadequate education and training.
One of the best services government supplies (other than keeping the roads patched) is preventing con artists from selling useless and dangerous products to uneducated and gullible people. This prevention costs far less than attempting to give each gullible and uneducated person a doctorate in biochemistry so that they could understand "all the known facts".
Your 14 year old daughter comes home and tells you she wants to run off with this charismatic pimp and get rich being a prostitute. You sit her down and explain "all the known facts". She rolls her eyes and runs upstairs to pack her suitcase. Do you sit idly by and say "well, she was given all the known facts upfront, it's her choice"? Most parents (perhaps not you) say no way, call the cops, because they see it as their job to protect those who can not understand, or refuse to believe "all the known facts".
Society has take the same stance with highly complex technical medical practices.
You can still find and obtain these unproven medical treatments, but society is not going to allow them to be sold in the market until they are proven. This is done because 1) there are real pimps in the world, 2) when it comes to extremely complex medical procedures a very large percentage of us are 14 years old.
Sig Battery depleted. Reverting to safe mode.
And I know lots of doctors (and other researchers) who are sure that the work they've spent years on is having great results - only to find out that finally, when decent studies are done, the results are no better than chance - if that.
Confirmation bias, placebo effect and other human fallacies often blind researchers -- and patients. For years both doctors and patients had thought that arthroscopic debridement of osteoarthritis was an effective treatment. Turns out that once you actually do the proper study (with sham surgical sites and anesthesia) it doesn't help.
The big issue with stem cell work is indeed cancer. After all, you are taking a cell that has been largely shut down in terms of it's ability to produce any gene product or regulatory molecule and then opening some of those pathways up again. The basic definition of cancer is uncontrolled cell growth and we really don't know the control pathways very well at all.
Cancer can take years to occur, so even if you actually have an effective treatment you don't know it's safe until you have studied it for quite some time. A length of time that is ecumenical to making money off of something you've spent potentially millions of dollars on.
So yes, you need someone to make sure that people aren't being conned out of money and life.
Faster! Faster! Faster would be better!
They're not banning it, they're regulating it.
I'd absolutely condone last-ditch treatment for individuals but then that's often done anyway - in a controlled and reportable manner. In that way we can learn something from the outcome and improve the treatment in the future so everyone benefits.
This is about preventing organisations using stem cells as the latest snake oil cure-all while circumventing regulation on a 'oh but it's just your own cells so it's not a medical procedure' which is patently false.
It's either an effective medical procedure and needs regulating, or isn't and they're guilty of false advertising.
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If you're dying from an uncurable disease anyway, and the only hope is a new stem cell treatment with unknown risks and side effects, why shouldn't you be allowed the choice to at least try a treatment that *might* extend your life (knowing the risks), as opposed to the alternative of *definitely* dying?
Well, as long as that's the criteria, why not allow anyone to sell anything to the dying on the pretense that it might extend their life? Cocaine, meth, tobacco, homeopathic remedies (i.e., water), waterboarding (uncomfortable, but who knows, it might extend your life!), seances, or real snake oil, anything might extend your life if you're already dying! All for the low, low price of $4999! No, we're not merely trying to drain your bank account, what's a few bucks if it might extend your life? And if it doesn't work, you won't need it anyway.
Or, maybe we should watch out for people making unsubstantiated claims in an attempt to swindle the desperate out of their money? Sure, they may not need the money anymore, but I'm sure they'd rather it go to their heirs than a swindler.
So, I'd rather medical advances were done in medical trials. I'd like to see more people accepted into the trials, sure, when it's based on proper risk acknowledgement, and not on the boatloads of cash being generated (that comes later if it's actually proven, and then we get into a "what the market will bear" situation).
Remember that capitalism only works if both sides of the transaction are properly informed. Fraud and deception defeat that, which is why anti-fraud laws are on the books: to allow capitalism to work. If you're selling an apple for $1, I may choose to buy that apple based on knowing what an apple is, and what $1 is worth to me. If, however, that apple, sold as produce, actually is made of plastic and weights, that's fraudulent. Or, if my $1 is a counterfeit, that's fraudulent as well (though it likely falls under different laws, it's illegal for much the same reason). If a desperate person is told by someone that there is a treatment that can, or even merely might, extend their lives, but has no evidence for it, we generally rely on the government to punish them if they're lying that there is even a chance of success. The FDA is simply going to enforce this.