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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."
Liberals are happy with the expansion of the government.
Conservatives are scared shitless that without this power someone might smoke something they found in their backyard.
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.
One interesting side effect is that dialysis treatment is now a drug.
Law isn't logical, you can't p0wn it and get root permissions (unless you're a 1%er, in which case you are the law). But it is none the less weird that if dialysis was invented today, it would be considered a drug under than doctrine.
"Science flies us to the moon. Religion flies us into buildings." - Victor Stenger
Everything in existence can have a biological effect. Thus everything is a drug. Thus the FDA can regulate everything.
Better known as 318230.
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...
There's nothing like $HOME
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.
The FDA, a government bureaucracy, has "rights"?
Liberty in your lifetime
Government-encroaching Luddite religion suppressing science and freedom!
How'd I do?
Or, maybe it's just a good idea to have some sort of vetting process before people start mass-injecting biological material into themselves.
~ Whence do you come, slayer of men, or where are you going, conqueror of space?
But perhaps it is too little too late. There are dozens, if not hundrends of these clinics set up outside the US. Many are in Asia or islands in the Caribbean/Atlantic. Who knows how many people have been defrauded.
On the other hand, some of these shops might have reason to believe that stem cells only need to be extracted and applied to do their work. Jenner's small pox "vaccine" was just ground up scabs that he rubbed into a cut that he made in the patient's arm. Ridiculously crude by today's standards. But it worked. So perhaps (in their minds) some of these stem cell treatments could have merit.
But I don't think that is likely the case. Applied stem cell biology is quite complex, particularly since the body tries to keep stem cells from becoming cancer. In humans, it is more of an issue because we reproduce relatively later in life and rear our young for far longer than most animals. In other creatures, like newts, it is less of an issue and they can regenerate entire limbs.
Nearly all of these companies are probably well aware of how unlikely it is their treatment will help anyone, but can't say no to the truckloads of money. They don't want to perform the science that will lead to stem cell cures, and go after the crude "Jenner" method. The problem is that medical science has advanced significantly since the 18th century and conditions like joint pain don't exactly warrant unproven treatments in the same way that certain cancers might.
I, for one, look forward to the FDA shutting these operations down.
Experience proves otherwise.
But in the end, people get the government they deserve.
Look around you, if you live in the US, and what do you see ?
If you are honest, you must admit that you see a vast ocean of human waste.
Quick! I need an ideological purist to tell me what to think about this!
The problem thats not covered is there is enormous pressure to bring products to market and make money. Without some backstop, the drug companies would end up testing their wares on the populace.
We have seen plenty of instances of companies that continue to ship products even -after- they know they are dangerous. Vinyl Chloride propellant for instance.
I am not sure if there are different "tracks" through FDA. One for cosmetics, vs another for life-saving medicine. Maybe that is a way to load the system for maximum benefit. Or if this is a new system that will replace an existing system without benefit on cost or safety it should go to the back of the line.
Regenexx is doing what many athletes are doing to their knees or shoulders to repair cartilage. A lot of athletes including Kobe have done a lot better because of this. They'll be the guinea pigs I guess.
The FDA's job is to require that drugs are "safe and effective". Most new drugs fail those tests during the development process. Some work in test tubes, but not in animals. Some work in animals, but not in humans. Some are unsafe for some fraction of the population. Some look useful in humans at first, but a few years downstream, haven't improved health or survival rates. Only about 13% of small-molecule drugs, and 32% of large-molecule drugs that start phase 1 clinical testing make it to actual use.
This is why there's a need for so much clinical testing, data collection, and feedback. Without that, nobody knows what really works, and there's no forward progress.
The "right to healthcare" officially does not exist as long as government can totally block you from getting the treatment you want.
Put people in charge who dont do anything but fuck up everything they touch because its a business for making money instead of a institution for that helps improve peoples lives through medicine and science. What a fantastic idea!
I still blame christians for the severe lack of stem cell research and useage. If it werent for those close minded and moronic assholes that cock blocked stem cells for decades we could be so much further ahead than we are now. And now the FDA has a say in this. Whoopie.
This wont help squat though. FDA will still stiffle stem cells in order to keep pharmaceutical companies and medical supply companies in their money because they are major donators for all government bribery.....I mean donations /wink
I have a half way solution. Keep the FDA but make it an advisory board. This way you can still sell any herb or crazy therapy you like but those that want things that are proven to be effective can look for things that are FDA approved. If you tried every approved treatment with no results you might be desperate enough to try some crazy stuff.
I love Jesus, except for his foreign policy.
I wonder if endorphins released during happiness will be considered a drug next. "Beat cop officer Joe sees little Sally on the corner smiling. Hey little girl, you better turn that smile off, right now! She doesn't. Okay little girl, cuffs on wrists, you're going downtown. We'll have no endorphin releases on my watch."
Just noticed for the first time that you left a comment on an old submission of mine pointing to this blog entry. For some reason didn't get a notification on that at the time and now this thing is archived. Hence my abuse of this comment thread.
Anyway, just wanted to let you know that I enjoyed reading the chapter of your SF story that you linked to, and was wondering if you ever completed that story?
I know that was a troll post, but I have to admit it was so damn random and funny I just had to laugh.
FDA took a decade longer than the rest of the first world to permit beta blockers.
Consequently, about 100k people died in the USA who would otherwise have lived many years longer.
They now have regulatory control of the most fundamental medical technology of all, stem-cell treatments.
They will for sure stop some harmful treatments and by doing so save some lives - lives of people who knowingly chose their treatments.
They will equally delay and discourage an unknown number of treatments which would save many lives - probably many many more lives.
Instead of a market where companies race forward to develop new technology, we have a market where the dead hand of the State stifles innovation.
This is the worst, the worst news.
Am *I* going to die now, when I'm older, where I would otherwise have lived for the technology which now will *not* be developed in time?
Another strike for freedom, um, er...I mean for Corporate Pharma! Just think of it, it's for the children you know. Any corporate treatment is not harmful, has no bad side-effects, until the stockholders meeting. Who says the 1% doesn't have the other 99%'s interest at heart?
The mind conceives, the body achieves, the spirit manifests.
I am not an expert and I am not connected with this stem cell treatment facilities either. You see, I have seen one interview on TV (TFC) from my country about individuals who have gone through stem cell treatment in Europe (where it is allowed) and they tell their stories of how they were relieved of all pain after several years of suffering. One woman even consider it as a fountain of youth because after treatment she can do everything which seems impossible to do prior to her treatment. The only negative feedback about the treatment is the cost, which is extremely high, which means an ordinary person like me who works to death to make money to support my family, the treatment may seems like a dream .
Yes, it is the responsibility of FDA to regulate this sort of things to protect the citizenry of United States, But my question is, what can FDA say about a lot of drugs sold in the market back up with several years and tons of research studies, but was later found out to have bad side effects, sometimes even death?
... Because EMBRYONIC stem cell treatments are the only chance we have to cure hundreds of degenerative diseases. Adult stem cell treatments are ineffective and dangerous, causing cell mutations and host to graft rejections, as well as costing over twenty thousand dollars per treatment and not covered by insurance. It has taken 8 years longer than it should have to get the first hESC retinal studies approved, and the results are everything they were predicted to be in animal trials (and more.) Safe, effective, and helping blind people regain vision!
There is only ONE reason why adult stem cell treatments are being pushed-- the Catholic church is supporting them, funding research, and spreading misinformation about embryonic treatments, the only ones that offer real hope. This is the worst case of church pushing into state and science going on today.