FDA Wins Right To Regulate Adult Stem-Cell Treatments 216
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."
A rather logical move (Score:5, Informative)
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...
Re:Interesting side effects (Score:3, Informative)
Not necessarily. This is a court decision, not a new statutory law. A significant (very very very significant) part of the job of a court is to decide over specific cases and whether the law, in word and in spirit, is supposed to apply to that case. They ruled that in this case (stem cells) it does. In the case of dialysis, they might not (probably wouldn't, since it is a proven long-standing and genuinely routine medical procedure). It is a very fine line, but that is what the courts are for: so that they can walk that line, and the legislature doesn't have to (of course, the legislature often does, but that is a different problem).
Re:And not a thing will be done about it (Score:3, Informative)
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.
Re:Interesting side effects (Score:4, Informative)
A number of doctors do think dialysis should be better regulated than it is now, to ensure that patients are getting actually good care following scientifically validated practices. The two options are basically to regulate it as a drug, or as a medical device [thekidneydoctor.org].
Re:And not a thing will be done about it (Score:5, Informative)
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).
Re:Good thing?? (Score:2, Informative)
The core concept here is that the treatments in question have not demonstrated that they:
1. Are effective at treating the maladies for which they are prescribed.
2. Are not likely to cause side effects that aren't well understood.
3. Have disclosed all known risks to the patients prior to administering treatment.
The FDA is the agency tasked with ensuring that medical treatments comply with those requirements. They were founded because the free market will left to it's own devices favor snake-oil salesmen who sell "miracle cures" that are cheap to make required no R&D (because they don't actually work) and are marketed as having vague health benefits so as to side-step advertising fraud legislation. Think "head on (apply directly to the forehead)", only in "injecting stuff into your bloodstream" form.
Re:And not a thing will be done about it (Score:4, Informative)
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.
Re:And not a thing will be done about it (Score:5, Informative)
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 [hss.edu] 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.
Re:And not a thing will be done about it (Score:5, Informative)
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.