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."
Interesting side effects (Score:3)
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.
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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
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I suggest you test out that theory. Call up the IRS and tell them all about your plan to not pay. See how it works out.
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So then take it to SCOTUS.
People smarter than you have tried and failed.
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Not really. Any time you're connecting a device into somebody's veins or putting liquids into somebody's chest cavity, the government should regulate the safety and efficacy of the treatment. It's not like we're talking about foot massages here....
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Dialysis was already governed by the FDA as a device and through drug regulations. The machines are devices, the dialysate is a chemical formulation.
I'm trying really hard not to call you a dumbass. Yes, I will take the higher ground and not call you a dumbass.
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].
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...
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Why not an advisory board instead? (Score:2)
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.
Good thing?? (Score:4, Insightful)
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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
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Even if sale of these treatments was not regulated there is the issue of how someone is supposed to make a rational decision as to what the effectiveness and dangers of the treatment are, and a process for validating the ongoing quality of the products being used.
Right? (Score:4, Insightful)
The FDA [eprci.net], a government bureaucracy, has "rights"?
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Ah, well spotted... This wording is indeed problematic. Government bodies have no rights, only missions, and anything that isn't part of their missions is forbidden to them.
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That's outmoded 18th Century thinking, we're so much more evolved now, and our Living Constitution needs to be rethought in this new age, with so many more smart people in government. Why, the intellectual capacity of 500+ Legislators, not to mention the tens of thousands of bureaucrats, is surely wiser than the handful of technologically ignorant Founders...
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A constitution is not the act of a government, but of a people constituting a government; and government without a constitution is power without a right. All power exercised over a nation, must have some beginning. It must be either delegated, or assumed. There are not other sources. All delegated power is trust, and all assumed power is usurpation. Time does not alter the nature and quality of either.
-Thomas Paine.
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Equal time (Score:2)
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.
It's about time (Score:3, Insightful)
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.
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Right, right. It's better to put someone on opiates to manage the pain and send them driving home, or to inject them with cortizone and cause them to bloat up - and if the patient is female to develop hirsutism. Yes, it's far better to do that than to try something which has a very high potential of actually rebuilding the cartilage.
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How do we know it has a high potential of doing that?
Please show us the studies. What we have instead is you suggesting we try random untested procedures instead of pain management that we know works. I would imagine the risk of unsightly hair is more manageable for the patient than a totally unknown outcome for what may well be no actual improvement at all.
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a very high potential of actually rebuilding the cartilage
Citation needed.
I have a PhD in developmental biology (closely related to stem cell biology). I effectively work in the pharmaceutical industry. If it had been demonstrated that simply extracting, concentrating, and injecting stem cells actually rebuilt cartilage, you would see many legit biotech companies running this through the regulatory process as fast as possible. But you don't.
Also, if you talk to any physician, FDA staffer, or pharma worker, you will realize there is a necessity to balance efficacy
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The theory of how this works is that it is a purified version of microfracture [wikipedia.org], which is now prevalent (especially among athletes) and accepted. Microfrature works because the stems cells from the bone marrow form new cartilage, which produces hyaline cartilage material, but also lots of stuff you don't want, making the result inferior to pure hyaline cartilage (called fibrocartilage). So in theory, if you remove the crap (isolate the stem cells), you can get a more pure cartilage formation.
It makes sens
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I claim I have a magic rock that has an 11000% percent success rate.
I suggest we actually test both of them, with a real double blind study. Some folks get saline some get this crap.
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Hmm. I am going to have to dig through some of the citations in that Wikipedia article. I am a bit skeptical, but need to see the science behind it to know how legit it is. Unfortunately, much of what I saw in the article seemed more like results from case studies rather than randomized trials.
Thanks for the background.
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You said:
"Applied stem cell biology is quite complex,..."
That is the key here. You think it is complex, but looking at the postings above yours, and at least one followup to it, people are thinking that the FDA, scientists, the whole edumacationistic cabal, are making things too complex to preserve their authority. See for example, postings saying there's enough information out there that people can come to their own conclusions and decide for themselves. See how anti-vaccine kooks get copious air-time (any
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Good point. Stem cell biology is complex, and not just because I, or a legitimate authority, says so. But some people don't want to believe that is the case, or think they are knowledgeable enough to review all the information and decide for themselves.
I think the same mentality is at play with nuclear power plants. People think they have enough information to make an informed decision about whether a reactor should be built in their neighborhood, but that is not likely to be the case.
I don't think people s
Wat? (Score:5, Funny)
Quick! I need an ideological purist to tell me what to think about this!
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You should love/hate this without doing anything to analyze it, of course!
Basic truth: most new drugs don't work (Score:2)
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.
Th
Healthcare a right? (Score:2)
The "right to healthcare" officially does not exist as long as government can totally block you from getting the treatment you want.
Re:And not a thing will be done about it (Score:5, Funny)
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.
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I know some doctors that have been having wonderful, and in some cases amazing results with this type of treatment. And now, sadly, you will have federal bureaucrats and miles of red tape standing in the way.
I mean, it shouldn't be that bad...they are only taking YOUR own adult stem cells, and generally, injecting them into your problem areas, and allowing your own body to heal itself.....
Now? Well, the feds will bog thi
Re:And not a thing will be done about it (Score:5, Funny)
Re:And not a thing will be done about it (Score:5, Insightful)
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 [wired.com]. 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.
Re:And not a thing will be done about it (Score:4, Insightful)
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.
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.
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So. Fucking. True.
Apparently some people have never heard of Asymetry of Information. Mostly the same people who babble about the Invisible Hand without knowing anything about what the concept means and is based on.
Re:And not a thing will be done about it (Score:4, Insightful)
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.
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Well, considering that all of these physicians I'm speakng of, have been the heads of their departments at hospitals, VAs and teaching hospitals which do a lot of research....and that these cases they're working on, ARE part of studies ongoing...sure, I think they're qualified.
Or...do you hear the word 'doctor' and automatically think of someone that is a money grubbing quack/charlatan that will do
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.
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Well, considering that all of these physicians I'm speakng of, have been the heads of their departments at hospitals, VAs and teaching hospitals which do a lot of research....and that these cases they're working on, ARE part of studies ongoing...sure, I think they're qualified.
Name one.
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Trouble is..this is gonna stop a LOT of use tx going on now with private physicians!!
I know some doctors that have been having wonderful, and in some cases amazing results with this type of treatment. And now, sadly, you will have federal bureaucrats and miles of red tape standing in the way.
Wait, you know this HOW? Because these doctors TELL you so? (chortle).
If the results are THAT good, they should be able to prove it fairly easily, right?
So no problem. It gets approved.
On the other hand, if (like way way too many) their claims are baseless, they get booted from the market before they can hoodwink people like, well, uh, you.
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Why would you automatically think someone was trying to con someone?
Do you have some kind of knee-jerk, inherit distrust of anyone with the title of Dr?
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Because that is what this ruling is about. It is about charlatans selling a procedure to inject some processed stem sells to cure everything.
A study, even one done by a private company is not what we are talking about. A proper study is going to be paying patients, not charging them. A proper study will not be making advertising claims about the magic of stem cells.
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Do you have some kind of knee-jerk, inherit distrust of anyone with the title of Dr?
No, only those pushing unproven treatments.
Stay up late an watch all those guys with a title of Dr pushing these things on late night TV ads.
If, after a few nights of this, you still trust everyone with a Dr after their name, then Dr. Icebike has some very cheap lake front building lots to sell you on the shores of Central Park Lake, in the heart of NYC.
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Your response only makes sense if you BELIEVE these unproven procedures will work.
Which of course already makes you the sucker that society is trying to protect. Go get a proven treatment, and stop trusting charlatans.
Re:And not a thing will be done about it (Score:5, Funny)
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.
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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.
WARNING: Done by professional drivers on a closed track under controlled conditions. Do not attempt this yourself. Past performance no guarantee of future success.This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease. Do not taunt Happy Fun Ball.
Just thought I'd flesh out your helpful and succinct post.
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Or - back in reality - it would stop desperate patients/relatives being fleeced by 'doctors' promising results from unproven techniques. I assume these kind doctors are not offering a 'no fix no fee' deal?
As for "it shouldn't be that bad" taking cells from one place and putting them somewhere else. Hello, cancer? Endometriosis?
This is the same dodgy reasoning that says 'natural' remedies are better because they're 'natural' and so are we... politely ignoring that what you're putting into yourself has been
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Trouble is..this is gonna stop a LOT of use tx going on now with private physicians!!
I'm sorry, but I have no clue what that sentence means. What is a "use tx"?
As to the coherent part of your comment, I must disagree. You don't know what is going to be the result of ANY medical procedure until it's thoroughly tested. I don't want to be the guinie pig for any medical experiments, but if you're ok with your doctor saying "we're not sure what injecting this stuff into you will do but I think it might help and
This is completely off-topic (Score:2)
Just noticed for the first time that you left a comment on an old submission of mine [slashdot.org] pointing to this blog entry [wavewatching.net]. 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?
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That's the problem here, really. Unregulated market: lots of nasty shit that's either expensive and ineffective (read: scam) or outright dangerous (read: scam that can kill you) diluting the market, so finding life-saving treatment is nigh on impossible. Regulated market: Twenty years to get life-saving treatments to market, prove it looks safe, find out forty years later it's a terrible idea.
At some point we need to stop being so damn protective of human life and let a few things slip by. Seriousl
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The problem is, it is unclear how relaxing human testing regulations would shake out. While it is true that there are certainly people out there who would gladly give something a try, those people are usually desperate. It is extremely easy to prey on people who are either desperate or who can be made to be desperate.
Litigation and publicity-wise, it is also very dangerous as well. Despite the fact that the person may have given permission properly, their relatives may well have decided that you took adv
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Well there's waivers and we can write the laws to protect researchers who follow the proper procedure and provide the proper disclosures.
What's wrong with taking advantage of the desperate for medical research? Imagine living with cancer, in pain every day, as your body rots. The doctor says in 4 months your vital organs will fail, maybe sooner, maybe a month or two later. Now this guy shows up with a treatment that may clear the cancer, but could also destroy your nervous system or cause your vital o
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Ethics not much a concern to you, eh?
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A lot of ethics are imaginary, but on the other hand some ethics are quite arbitrary as a point of necessity. For one thing, you can't save a starving man by feeding him--he's starving for a reason, and if he gets food today that just means tomorrow he will need more food. On the other, there's something to be said for your humanity if you're willing to give it a try against sense. In the same way, we try to avoid blatantly becoming tyrants and monsters to "save" people, because then they get to live i
Re:And not a thing will be done about it (Score:5, Insightful)
I think almost everyone is fine with government regulating dangerous unproven medical treatments with potentially horrific side-effects.
Re:And not a thing will be done about it (Score:4, Insightful)
Re:And not a thing will be done about it (Score:4, Insightful)
" 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.
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" 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.
I am fairly sure that most medical drugs do not require you smoke them. Even if they did, I see no reason why they couldn't smoke them in private. If they deem that smoking is worth the risks, it is their choice to make, stupid decision or not.
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.
Yes. There are stupid people out there. There will always be stupid people out there. That said, I would rather accept the risk that some people are going to make stupid and emotional decisions than to have the government come in and make decisions for everyone.
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Then how do you explain why people still smoke in public places?
People are stupid, which is fine, if their own stupidity only affects themselves, but when their stupidity starts affecting other people the government does have a legitimate role in stepping in to protect other people. It is very difficult to figure out where that line is in many cases.
Right now, there are tons of examples of nutrient suppliments blatently lying a
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Even if they did, I see no reason why they couldn't smoke them in private
Then how do you explain why people still smoke in public places?
People are stupid, which is fine, if their own stupidity only affects themselves, but when their stupidity starts affecting other people the government does have a legitimate role in stepping in to protect other people. It is very difficult to figure out where that line is in many cases.
I was talking about smoking in private. You are correct. I can see some restrictions on where you are allowed to smoke in public.
Right now, there are tons of examples of nutrient suppliments blatently lying about their effect and contents of their suppliments. How can anyone make up their mind in this case? Shouldn't the government step in and require these companies to do proper research?
That is why I said there should be government mandated transparency. Outright lying about the effects or side-effects of a product would be considered criminal. If the business didn't do any real research, the customer has to be told so. If business did do research, the customer has to be told the results. Intentionally, hiding known effects and statistics would be criminal. I see
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.
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In that case, you should lobby for the complete defunding of the Food and Drug Administration.
But failing to achieve that aim, you will have to put up with the majority view that such protection is
in the best interest of society.
There is precious little difference between a teenager and gullible low IQ adults that are easily hoodwinked by medical charlatans.
One key similarity between these groups is the belief that they are fully capable of making their own medical decisions, even
when they haven't the sligh
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You are giving a counter argument by bringing up an extreme version of the contrary.
Government needs the correct balance, more control in some areas and less in others. If you are taking products that are sold to be ingested or said to help cure you of an issue, it should be regulated as to not allow snake oil sales men selling products that give people false hope or makes it worse.
When people are sick they are often desperate for care, and will make rash decisions.
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That assumes, wrongly, that you are capable of understanding the facts in context, and that you would be capable of finding alternatives and assessing facts against those. There's a reason doctors can't just prescribe you any damn thing they feel like, but rather have be to be given a list of allowed and approved medications, it is that they don't have the background even.
It's only a fairly small set of the research community who have enough of a background in both stats and other pharmaceuticals to accurat
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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, e
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).
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Basically it's the left side of the aisle getting revenge for not getting unlimited Federal support for embryonic stem cell research. If they're not allowed to harvest fetuses for stem cells, they won't make it easy to use adult stem cells.
Quid, meet pro quo.
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No one ever harvested fetuses for stem cells. They used medical waste from abortions. No abortions were done just to get some stem cells.
Who told you this stupidity or did you make it up yourself?
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injecting them back into your problem areas in a concentrated form basically.
which does what good exactly? What risks are associated with doing that? Are their risks to the procedure itself rather than just the stem cells?
Sad...this one is a battle that should have been won by the doctors,
this is a battle that should revoke medical licences for anyone who was providing such 'treatments'. If you don't have strong evidence of the risks/benefits of a procedure you shouldn't be allowed to perform it on the general public. That's basic consumer safety. Most of these 'treatments' are at the level of undergraduate guessing in a laboratory, and have
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The market in action? That is your fucking response to people being maimed? You think it is ok that some people get killed so you can save a couple bucks on cosmetic surgery?
You are one sick fuck.
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So because one case slips through we throw out the whole system?
As opposed to your system, were we let everyone do this and chalk up all the deaths to the hand of the free market. Yeah, I am sure the free market which can only act after the deaths from the janitor turned brain surgeon are news will do more to protect those most at risk.
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When was this?
Because under the actual free market, before the government stepped it al all, we had patent medicine and people were dying from it. We founded the FDA because the free market failed to provide care. Instead it provided untested and useless garbage at low low prices.
Lasik eye surgery is not a free market at all. Those are regulated medical devices they use. Pet care comes mostly from human care, the human care paid all the costs. The risks are also much lower as the value of the patient is far
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Patent medicine has nothing to do with patents. You should look into why the FDA was created.
The problem with your idea and it was tried in the past is that the information cannot spread as fast as these folks change their names and companies. If I need to go the ER for bleeding from my anus I cannot read every review on yelp to see which doctor will save my life. The profit the more likely those reviews will be tampered with.
Lasik eye regulations exist and ensure safety. Veterinary care is not cheap, I jus
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Bullshit, if they make any claim at all when selling a product they should be able to prove it. How many thousands of dollars are wasted every year on enzyte and magnetic bracelets, and homeopathic drowning cures?
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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.
I wonder what did the conservatives say, after they discovered that thalidomide caused abnormalities in the new borns?
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Re:And not a thing will be done about it (Score:5, Interesting)
http://www.hoover.org/multimedia/uncommon-knowledge/26936 [hoover.org]
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.
Re:And not a thing will be done about it (Score:5, Interesting)
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.
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The role the FDA is supposed to fill is a desirable one, the problem is that it
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You know that economics as a science is fundamentally flawed when it expects that people are out to serve their best interests.
and realized you were disagreeing with the notion that people try to act in their own best interests. That makes my paragraph (in the post below) about drug companies acting in their own best interests pointless in this context. My bad.
I do actually think it is shocking that you don't think people are out to serve their own best interests (generally). They can certainly fail to actually determine what will serve their interests bests but I still think it is self evident that they are tryi
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How is this an expansion of government? The FDA regulates food and drugs. Most sane people want food and drugs to be regulated because we aren't microbiologists.
This false choice between communism and anarchy needs to end. We can't have proper debates while it's pushed like this.
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How is this an expansion of government? The FDA regulates food and drugs.
Because stem cells are neither a food nor a drug.
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Looks like it is being used as a drug to me...
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A drug is defined by how you use it, not its contents.
Homeopaths use water as a drug. Many people use prayer as a drug. That doesn't make them drugs.
Stem cells are a normal and natural part of your body. Claiming that they are "drugs" is absurd.
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They are drugs as they processed in this fashion.
Also this entire procedure should be regulated in the same way any surgical procedure should be.
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That is only FSTYPIOOYBA (Federal Stuff That You Put In Or On Your Body Administration) just doesn't have a nice ring to it.
Re:Everything (Score:5, Insightful)
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?
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Because, largely, it is not a bunch of hack doctors doing this....I know some very reputable physicians, that are getting some amazing results from this, and since it is your own cells, not that much a problem with side effects.
And no...they don't just 'do' this to un-informed patients...they discuss it with them, risks/benefits...and have signed consent forms.
The majority of doctors
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Yes, as they should if that 'everything' is claimed to have medicinal value.
That is their mandate. Whether or not the FDA does things the right way is another story.
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No, they can't. They can't regulate the homeopathic flim flam because it's not classified as a drug. Which it isn't.
The same thing with vitamins and supplements. Since they aren't classified as drugs, there is no regulation. No one knows what's in these things because the companies don't have to tell you what's in them. Testing has revealed that in most cases, sugar is the number one ingredient.
That's why homeopathic "medicine" isn't real medicine. They
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I see a well appointed cubicle farm and some trees out the window.