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."

Comments

And not a thing will be done about it

[Anonymous Coward]

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.

Re:And not a thing will be done about it

[tnk1]

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.

Re:And not a thing will be done about it

[Baloroth]

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

[fufufang]

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?

Re:And not a thing will be done about it

[MickyTheIdiot]

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.

Re:And not a thing will be done about it

[cayenne8]

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.

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 this down, and of course, you'll somehow involve big pharma (which does have its place)....and take what is proving to be an effective, low cost tx for many diseases....and make it more costly, and harder to perform.

Re:And not a thing will be done about it

[ShanghaiBill]

How is this an expansion of government? The FDA regulates food and drugs.

Because stem cells are neither a food nor a drug.

Re:And not a thing will be done about it

[Githaron]

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.

Re:And not a thing will be done about it

[cayenne8]

I think almost everyone is fine with government regulating dangerous unproven medical treatments with potentially horrific side-effects.

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:And not a thing will be done about it

[MickyTheIdiot]

Looks like it is being used as a drug to me...

Re:And not a thing will be done about it

[demonlapin]

It is possible to oppose the FDA's current mission without simultaneously wanting to abolish safety testing. The FDA is far too wrapped up in making sure things are safe and effective, which sounds like the sort of thing you would want them to do until you look at how the process actually works. The FDA as it is now turns down drugs it shouldn't. (I'm still pissed off about sugammadex.)

Re:And not a thing will be done about it

[Anonymous Coward]

So what you're saying is - don't mess with tx.

Re:And not a thing will be done about it

[englishknnigits]

Milton Friedman addresses 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.

Re:And not a thing will be done about it

[jellomizer]

" 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.

Re:And not a thing will be done about it

[Baloroth]

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:And not a thing will be done about it

[CptNerd]

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.

Re:And not a thing will be done about it

[jellomizer]

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:And not a thing will be done about it

[gmack]

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.

Re:And not a thing will be done about it

[Sir_Sri]

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 accurately assess data from trails, and trials themselves need layers of regulation so you don't kill any more people than is absolutely necessary. And even then they take far too long to even document the risk/benefit rewards of drugs for anyone on an individual basis to wait on their work.

Also, companies would simply lie or obfuscate any facts about their drugs that are inconvenient to sales (they try and do that already to doctors and drug approval boards). The only real way to deal with that is to make sure you have a layer of experts who are supposed to have working bullshit detectors between the pharma companies and the public.

Re:And not a thing will be done about it

[fustakrakich]

What happened? Your doctor was shut down?

Re:And not a thing will be done about it

[Sir_Sri]

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 no place in the general public, and anyone so reckless as to perform them should not be practicing medicine.

Stem cell therapy is very promising, but that doesn't give you the right to sell someone the chance to be a poorly thought out lab experiment. That could go real badly real fast. Offering a procedure without any proven benefit is nothing but theft.

Re:And not a thing will be done about it

[Githaron]

" 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.

Re:And not a thing will be done about it

[ShanghaiBill]

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.

Re:And not a thing will be done about it

[Rob Riggs]

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.

Re:And not a thing will be done about it

[h4rr4r]

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.

Re:And not a thing will be done about it

[h4rr4r]

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?

Re:And not a thing will be done about it

[icebike]

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.

Re:And not a thing will be done about it

[Bill, Shooter of Bul]

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.

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?

Re:And not a thing will be done about it

[h4rr4r]

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.

Re:And not a thing will be done about it

[P-niiice]

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.

Re:And not a thing will be done about it

[cayenne8]

You know some doctors that are having amazing results, but can't manage to prove it in a double blind study?

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 anything to a patient/sucker for a buck?

You know...most of your doctors out there, went through shit for med school, many came out with debt that would make the people complaining about undergrad college debt puke...and aren't getting rich due to all the complications of medicine these days.....and yet they still do the job they love, to help people out....and because it is interesting and ongoing human science.

Re:And not a thing will be done about it

[P-niiice]

Hm yes this works perfectly with our election process so why not

Re:And not a thing will be done about it

[h4rr4r]

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.

Re:And not a thing will be done about it

[cayenne8]

I worked in medical research for a number of years....associated with a major teaching university, and the work by these doctors IS research, now in private clinics. Along with published results, etc.

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?

Re:And not a thing will be done about it

[h4rr4r]

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.

Re:And not a thing will be done about it

[P-niiice]

And posts like this are precisely why we need to have rational people regulating medical procedures.

Re:And not a thing will be done about it

[kenorland]

I think almost everyone is fine with government regulating dangerous unproven medical treatments with potentially horrific side-effects.

That's not the problem. The problem is deciding what actually is a "dangerous unproven medical treatment with potentially horrific side-effects", and that's far from clear. A big part of our medical costs goes into attempting to ensure an unnecessary degree of safety for drugs and treatments, while problems that kill people in large numbers remain un-addressed.

So, how many thousands of dollars is it worth to you a year to have your risk of death from bad drugs reduced from 1:100000 to 1:1000000?

Re:And not a thing will be done about it

[h4rr4r]

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.

Re:And not a thing will be done about it

[Mister_Stoopid]

If the results are THAT good, they should be able to prove it fairly easily, right?

If by "fairly easily" you mean, ten years of clinical trials and hundreds of millions of dollars.

I guess I'll just have to hope I don't need any of these treatments in the next decade.

Re:And not a thing will be done about it

[h4rr4r]

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?

Re:And not a thing will be done about it

[icebike]

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

[roman_mir]

So because one case slips through we throw out the whole system?

- yeah, you have already threw the hole system based on a small percentage of people who had problems, you created this monstrosity of a system that is falling apart under its own weight and is taking the economy with it, you have done it as a response to a small number of cases where people had problems given a much freer market. Of-course they had other forms of solutions then, there was actual charity, doctors were working pro bono, this was the norm.

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, bullshit. Under the free market the prices were falling, choices were growing, so was quality. Choices were growing and quality was growing in the health care the way the choices and quality are increasing in mobile phones today.

The relatively free market for lasik eye surgery, and definitely much freer market for veterinary care for pets shows that the free market is much more efficient, the prices are falling or at least not going up at all, which given the insane inflation caused by gov't money printing is equivalent to falling prices if the money was stable.

Re:And not a thing will be done about it

[fufufang]

I think almost everyone is fine with government regulating dangerous unproven medical treatments with potentially horrific side-effects.

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.

You do know that the injected stem cells could easily become cancerous and kill the patient? Regulating medicine is what FDA set out to do.

http://blogs.discovermagazine.com/80beats/2009/02/18/embryonic-stem-cell-therapy-causes-cancer-in-teenage-boy/

Proper regulation gets rid off snake oil, so the patient can pick those proven treatments. In this particular situation, it is more than getting rid off snake oil. It is about safety.

Re:And not a thing will be done about it

[icebike]

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

[h4rr4r]

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 lower.

Any other bullshit you want me to debunk for you.

Re:And not a thing will be done about it

[englishknnigits]

I would suggest reading his arguments then responding. He clearly stated (even in this excerpt) that the FDA does do some good things and does protect us from bad food and drugs. His primary point is that the FDA also protects us from safe, effective drugs and safe food. His argument is that it does more damage than good, not that it doesn't do good or that there wasn't a legitimate reason for wanting something like the FDA.
The role the FDA is supposed to fill is a desirable one, the problem is that it doesn't do it well.
You are correct that people generally act in their own best interests. Drug companies are no different. If they poison and/or kill people they will lose vast amounts of money through lawsuits and lost of future customers due to destroyed trust. Drug companies like making money so it is in their interest to test their own drugs.

As for your arguments about people being idiots, who do you think runs the FDA? Robots? No, they are the very same people you don't trust to make decisions for themselves. If you don't trust people to make decisions for themselves, which they have a huge vested interest in, why do you trust people to make decisions for other people, of whom they have little vested interest?

Re:And not a thing will be done about it

[icebike]

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.

Re:And not a thing will be done about it

[englishknnigits]

Doh, just re-read:

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 trying to do so.

Re:And not a thing will be done about it

[Rob Riggs]

I *do* think that people *intend* to serve their own best interests. I also think that people are intensely manipulated while pursuing that goal. My wording is less precise than I would have preferred. People fail to serve their own best interests because of information manipulation. The FDA exists in order to prevent the most egregious abuses against the most vulnerable of us -- those that are sick and dying.

Re:And not a thing will be done about it

[bluefoxlucid]

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. Seriously, it shouldn't take lots of experimental tests, animal tests, petri dish pre-clinicals on human tissue, then clinical trials that are still ridiculously hard to get approved, then another decade of bullshit before we can get things to the market. Clinical trial: this is risky as hell, the treatment may be ineffective or dangerous, we've somewhat-kinda tried it on mice and on human tissue, aiming for an exclusive experimental group of volunteers. Experimental stage: Worked out in the clinical trials and after a year or three nobody is showing signs of terrible side-effects, still experimental but we can advise you try this with reasonable certainty that you won't die. Established: It's established, essentially a meaningless upgrade.

Oh, people died? The treatment has problems. Yeah my cancer treatment killed 20 people but let's be realistic: they all had like 4 months to live anyway, no big loss. On the fourth or fifth try I'll get it working right, and then hundreds of thousands of lives will be saved; that's worth a handful of old dudes that were gonna die horribly anyway. Besides, I told them if it didn't work they might die horribly a few months faster; the ones that stayed around flatly did not care, so no sweat off my ass.

Re:And not a thing will be done about it

[h4rr4r]

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 just paid $1500 for a dental procedure on an animal. It would have been more on a human, but that is again because of the value of the patient. Even at $1500 many humans could not afford such a treatment.

Re:And not a thing will be done about it

[LuckyLuke58]

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? And it's nonsense to ban it on the basis that some clinics might promote it with 'disregard' for safety .. firstly because patients are grown-ups, not children - adults are capable of knowing and understanding that there are risks with new treatments (really, do you really think ALL adults are such braindead children mentally that they'll honestly believe it's a "magic cure"? Don't be fucking stupid.) .. and secondly, because many physicians are actually responsible.

Re:And not a thing will be done about it

[LuckyLuke58]

Ha ha, I guess if you can't use facts and reason to rationally rebuke an argument, then resort to childish insults like calling it "groupthink". Could you explain why the argument is wrong instead of just resorting to ad hominem logical fallacy?

Re:And not a thing will be done about it

[LuckyLuke58]

I am currently watching my mother die of a completely uncurable disease for which some of stem cell treatments have shown promise in controlled, properly conducted scientific studies. Of course it's not your family member dying, so naturally you don't give a shit, but thanks for forcing your preference onto others, potentially killing some.

Re:And not a thing will be done about it

[DNS-and-BIND]

In other words, people have freedom of choice...until they make the Wrong Decision[tm]*. This freedom you speak of, I do not think it means what you think it means.

* Wrong Decision to be determined by a committee of your betters, the committee is guaranteed not to be stuffed with SWPLs.

Re:And not a thing will be done about it

[Githaron]

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 no reason why a third party businesses could not arise that performs a similar function of the FDA without all the government entanglements and government mandates. They would come up with their own rating and standards. If a company wants to be able market their drug with an "official seal of approval" from one of these rating businesses they have to follow the business's standards. Multiple standard of approval could be formed. Consumers could decided which standards they trust and which they don't. They can decided which drugs they trust and which they don't.

Re:And not a thing will be done about it

[Githaron]

Since when is the US government transparent?

Re:And not a thing will be done about it

[mutube]

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 processed and altered (dried, heated, distilled). Likewise for stem cell treatments: Transplantation requires a lot more than sucking them out and putting them back in - not least of all sorting and phenotyping. All cells grown in culture change and over time and most tend towards a cancer-like phenotypes absent control of their environment. It's forbidden to work on your own cells in a lab for this very reason: if you inadvertently transform the cells in vitro then self-innoculate they will not be killed (*effectively).

Seems exactly like the kind of thing where you'd want someone to know what they're doing.

Re:And not a thing will be done about it

[ColdWetDog]

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.

Re:And not a thing will be done about it

[tnk1]

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 advantage of that person and try and either bring you to court, or shame you publicly.

The simple fact that the process is so stringent helps ensure fewer cases of litigation and bad publicity. If you make the trial harder to enter, you eventually get to the point where the subject and even his family is begging you to let them enter. Heck, you might have even enlisted the media to pressure the study to let you in. At that point, if the subject dies, there's not much the family or the media can say: they begged you to let the subject in, you tried to warn them off. It's not your fault they died.

While can be heartbreaking to not be able to treat someone, it is worse for a researcher to have actual dead people on their hands. They're not going to want to open the pool to just anyone, and they certainly will not want some journalist comparing them to Dr. Mengele.

Re:And not a thing will be done about it

[P-niiice]

Since when is the government an electoral candidate?

Re:And not a thing will be done about it

[mutube]

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

[ColdWetDog]

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.

Re:And not a thing will be done about it

[ColdWetDog]

Ethics not much a concern to you, eh?

Re:And not a thing will be done about it

[mcgrew]

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 I'm trying it anyway", go ahead. But I want my doctor held to strict medical standards that have been tested and shown effective and safe.

Re:And not a thing will be done about it

[bluefoxlucid]

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 in a world full of tyrants and monsters who care nothing about numbers.

On the other hand, if the whole world is going to die, maybe it's better that a tyrant save it ... painfully. Try reading Brandon Sanderson's Mistborn series; it's not a straight shot, this happens partially in a few incarnations.

More subtly, we have the natural progression of the original point. We can't let people get taken advantage of, but then we write all these ethics rules and it gets to the point that 10,000 people die painfully a month from something we have 50 cures for but need 10 years to get a tentative approval for small scale clinical testing on. That's 1,200,000 people dead before we start testing? And then more time to review those tests... and if it doesn't work out, any adjustments take years to get approval because we're not going to keep sending people to the slaughter (you said this was gonna work last time, what's different now? Yes but how is that DIFFERENT?).

I don't see a severe ethical problem when we have people suffering and dying in great quantity and we take a few of the desperate ones that won't finish out the year and give them a candidate treatment that probably won't kill them and might cure them, or at least lessen the disease so they live longer and with less pain. If they die, who cares? They were gonna die soon anyway, and we can move on and figure out what went wrong. If we come out ahead, we come out ahead by millions of lives saved; and if we come out behind, in six months we won't be behind anymore because all those people who died in the attempt would have been dead by now anyway.

Not only that, but we warned them and they said try it anyway--they get a chance at life and even if it's a complete and utter failure they become part of the cure, which when you're dead doesn't really matter but when you're facing possible death it's comforting to know that if you don't come out of it alive, you'll still come out of it a hero. You'll find plenty of people who'll take either outcome because that kind of thing means something to them. Sure, being arbitrarily executed for some greater cause at 20 when you have a whole full life ahead of you sucks, regardless of whatever it achieves; but if you've got no way to live for more than a couple months and suddenly we can make your life meaningful on the scale of thousands of lives, that's a hell of a lot more than you could achieve just waiting to die. To some people, it's like giving them their life back--either way they cheat death and accomplish something they weren't given time for.

The loss is small, the gain is great, and the people are strictly volunteers. They stand to gain much, they stand to lose little, and some may find a deeper meaning in being part of medical research if things don't turn out well. I don't see the ethical problem here.

Re:And not a thing will be done about it

[bluefoxlucid]

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 organs to fail outright. It's a good try, at least.

What's the value of 4 months of a dying man's life? The primary value of a life is wages, and in this state you're not working so you're worthless. The primary philosophical value of a life is the struggle to live, which in this case is completely pointless because you're going to die. That an experimental medical procedure might kill you is plainly of no concern: it won't cost you anything, it won't cease your non-existent income, and it's the last possibility you really have for actually living. You might live, or you might just live longer--which both satisfy the survival drive of a dwindling life. It might kill you, but at least somebody tried.

Desperation. It comes when you face death. The cancer is going to kill me in 40 years? Shit I'll be dead in 40 years anyway, who cares? I don't need cancer treatment.

Re:And not a thing will be done about it

[jellomizer]

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.

Re:And not a thing will be done about it

[jellomizer]

You have the freedom of choice. However you should have people who are offering you the goods and services to be sure they are on the Up and Up.

Re:And not a thing will be done about it

[richpoore]

A large function of regulating is determining what is unsafe and regulating that it cannot be done until it's gone through batteries of testing (which has proven to grow the cost of medicine and treatments we have now). I would like the government to stay out of what I'm choosing to do with my own body unless it's harming someone else.

Re:And not a thing will be done about it

[richpoore]

Mod Parent Up This seems to be one of the most balanced approaches, concern for people without making decisions for them.

Re:And not a thing will be done about it

[richpoore]

Your analogy is flawed. First, the government does not have a parental role over adults. That's not its job. Your example is of a teenager with a prefrontal cortex not formed completely to be able to make rational decisions, not an adult.

Re:And not a thing will be done about it

[curiousJan]

tx is a medical abbreviation for treatment; just as rx is an abbreviation for a prescription medication. Although I will agree that I want my doctor held to strict medical standards, if I am in a terminal situation and there's an experimental tx out there, I want my doctor to be able to go through the pros and cons with me so that _we_ are able to make as informed a decision as to my care as is possible. The FDA has too much history of protecting the pharma companies rather than their actual customers, the patients (drug) and consumers (food). As someone who hasn't smoked for more than 2.5 years thanks to electronic cigarettes that the FDA fought tooth and nail to ban, my sentiments toward the FDA are that they can get the frack off my lawn!!

Re:And not a thing will be done about it

[Bill, Shooter of Bul]

This is pretty close to what the government is doing in this case, slapping down a medical prodcedure that doesn't have the benifits and risks well known. But yes, I would like there to be more idividual choice when all of the information is known. A painkiller recently was removed because the fda decided that the known side effect of a very small increase in heart attacks was no longer accepted due to the existence of other painkillers on the market. This pain killer was the only one that worked well for one of my siblings suffering from cronic pain. It didn't get them high, was non addictive and releived the pain without any appreciable side effect that is common with others. When its a known, small risk, the FDA should leave it up to physicians and patients.

Re:And not a thing will be done about it

[icebike]

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 slightest clue about the underlying biology.

Re:And not a thing will be done about it

[richpoore]

You're right, I'm having to put up with the seeming majority view that the government should keep protecting people from their own stupidity. I would advocate freedom to make my own choices over parenting governments making decisions for everyone because someone might make a bad decision and get hurt.

Re:And not a thing will be done about it

[P-niiice]

Not being considered an FDA drug IS telling the public about the lack of research and effectiveness. The red tape is to ensure that claims are true, drugs are safe and effective.

It's idiocy to remove the process. There is certainly room for improvement, I think everyone can agree.

Re:And not a thing will be done about it

[Tanktalus]

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.

Re:And not a thing will be done about it

[icebike]

Be careful what you wish for.

Imagine a situation where nobody ever thought of creating a food and drug agency, and every bit of food you purchased, and every medicine you needed could never be assumed to be either wholesome or effective. Anyone could put something on the market, make any claim they wanted, and sell it.

Buy a crappy Cell phone? Get a new one, and count it as a lesson learned.
Buy an crappy anti Cancer drug? Well, there is always re-incarnation to hope for....

There are some issues in the real world where no regulation is deadly.

Yours is a very short sighted view.
You essentially are claiming people can't band together to protect one another by keeping shysters out of the market place. Yet there has never been a time in human history where this was not done at some level, even if it just meant stoning the vendor trying to pawn off ropy flour or spoiled meat. That banding together is what we did when we created the Food and Drug administration, the FTC, the NRC, and a few other agencies entrusted to keep unsafe things out of the market place.

You can still vote with your feet. You can still buy unlicensed untested drugs. Perhaps just not here.

Re:And not a thing will be done about it

[cayenne8]

Stay up late an watch all those guys with a title of Dr pushing these things on late night TV ads.

The doctors I'm speakng of, that are doing stem cell therapy...are not the tv quacks you speak of....but all qualified physicians, with MORE than a few published studies to each of their names...all of those published are peer reviewed and approved!!

This isn't something you see advertised on late night TV my friend....

Re:And not a thing will be done about it

[cayenne8]

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.

Hmm..all the studies I participated in helping run, at a state educational learning center....didn't pay patients...the did inform them of the risks and benefits, made sure they understood, and consent forms signed.

That's what the doctors I'm talking about are doing...but in a private practice setting. They certainly aren't advertising this....only giving the options to patients that come in with qualifying problems. THey aren't advertising the options to have people come in....?

Re:And not a thing will be done about it

[icebike]

So then what's the problem?

The ruling does not affect studies, and with their sterling credentials they should easily be able to get their methods approved and go on to license the technology or make millions selling seminars and training. Wouldn't government approval be a gold mine for them both in money and prestige?

What precisely is the problem?

Re:And not a thing will be done about it

[Man On Pink Corner]

Thus demonstrating, yet again, that it doesn't pay to be the only sane guy in the asylum.

Re:And not a thing will be done about it

[kenorland]

Bullshit. I don't want to have to pay ten times as much for a simple drug just because people like you insist on an unreasonable level of safety. And I certainly don't want to die because some potentially effective treatment is kept from the market just because it causes lab mice to develop cancer. Risk assessment should be between me and my doctor, and it should be my decision, not yours or the government's. There should be strong labeling requirements, like "FDA certified" or "did not pass FDA certification", but the ultimate decision should be up to me.

Re:And not a thing will be done about it

[Schmorgluck]

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 processed and altered (dried, heated, distilled).

On this specific matter, it's more often a matter of being not processed enough

For example, digitalin, an extremely useful drug for some heart conditions, and is an extract from digitalis, a very toxic plant.

Another case is aromatherapy, which means using essential oils as therapeutic drugs, or components of therapeutic drugs. There are two problems with this stuff.

First, essential oils need to be extracted, and some methods are quite dirty, leaving plenty of shitty chemicals in the final product (including traces of acetone). Seriously, in the EU, the efforts to correctly label, and enforce said labelling, of actual best practices in the production of essential oils, have only started rather recently (ten years ago or so).

Second, many gullible people think that, because essential oils are just simple extracts of plants, they are inoccuous. And that lead them to unsupervised automedication. While pharmacologists have recently been making genuine efforts to scientifically assess the efficiency of essential oils, they also found out that some can be very toxic at high dose. And some, not even at high doses. An overdose of melissa essential oil can be lethal, for example. Don't take my word for it, but I seem to remember sassafras essential oil can cause photosensitive allergies. That's my point, actually. Essential oils are effectively active drugs, and should be taken with caution, like every active drug.

And I'm saying this as someone who's been raised in a fairly phytotherapy/aromatherapy household. But when I see a website about essential oils that doesn't start with a word of warning on its first page, I feel like burning it down.

Re:And not a thing will be done about it

[penix1]

I would like the government to stay out of what I'm choosing to do with my own body unless it's harming someone else.

Which it does when you end up with the very expensive treatments for the cancer this can cause. You are driving up the price of healthcare for us all. I would call that harming someone else.

Re:And not a thing will be done about it

[Schmorgluck]

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

[Schmorgluck]

What's wrong with taking advantage of the desperate for medical research?

Taking advantage of the desesperate, basically. That's not what medicine is supposed to do, FYI. Primum non nocere.

Re:And not a thing will be done about it

[Schmorgluck]

Because Darwinism has nothing to do with politics, economy, and sociology. That's why.

Re:And not a thing will be done about it

[khallow]

agine a situation where nobody ever thought of creating a food and drug agency, and every bit of food you purchased, and every medicine you needed could never be assumed to be either wholesome or effective.

Sounds like a market for an Underwriter Laboratories. Or it might require a bit of testing on my part. A grocery or restaurant could differentiate itself by offering testing and standards as part of its offering.

I use these in a hypothetical sense, but they are of obvious, considerable value and IMHO someone would implement them to get an edge over their competition. It doesn't happen in our reality because government has dominated that issue completely. One can compete on quality of foods and such, but not safety since everything has to meet a standard of safety already, it's pretty hard to stand out.

Re:And not a thing will be done about it

[nbauman]

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.

That is such bullshit. If they were having amazing results, they would be reporting them at scientific conferences and publishing their results, so other doctors could see whether it really was that great, and adopting it if it were any good.

If a doctor could produce results like that, venture capitalists would be throwing millions of dollars at him.

Re:And not a thing will be done about it

[nbauman]

You know some conmen, not doctors.

But he was wearing a white coat!

Re:And not a thing will be done about it

[nbauman]

You know some doctors that are having amazing results, but can't manage to prove it in a double blind study?

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.

Re:And not a thing will be done about it

[nbauman]

Place the vessel into a centrifuge but if you don't have that use a good clothes washer on the spin setting.

You can also use a bicycle wheel. Make sure to put one bottle on each side of the wheel for balance.

Re:And not a thing will be done about it

[nbauman]

This came up in a congressional hearing, with Sam Peltzman, another University of Chicago economist.

Peltzman claimed that there were effective drugs that weren't available because of excessive government regulations.

A congressman asked Peltzman to name one.

Peltzman said he didn't know specific drugs. That wasn't his job. He was an economist, not a pharmacist.

That illustrates one of the differences between economists and scientists. Scientists have an idea that sounds good, so they form a hypothesis, They test the hypothesis in the real world to see if it's true. If it doesn't work in the real world, they ditch it and work on another idea.

Economists come up with ideas that sound good. But instead of testing it in the real world to see if it's true, they just insist that it's true because they're so brilliant and the free market is so wonderful. At least, that's the way University of Chicago economists work.

Re:And not a thing will be done about it

[nbauman]

They're biological products. Blood is a biological product regulated by the FDA.

Re:And not a thing will be done about it

[Anonymous Coward]

It doesn't happen in our reality because government has dominated that issue completely. One can compete on quality of foods and such, but not safety since everything has to meet a standard of safety already, it's pretty hard to stand out.

Competition on safety can be found on black (and sometimes grey) market, where you can find unregulated goods and services (and their price/availability largely determined by free market, as the definition of black market is one that is outside of government control/interference). Prohibition showed that if the demand is there, a supply will be created even if it's illegal.

So you're wrong that government has dominated that issue (or any issue) completely. You can always go the illegal route.

Oh yea, there will be consequences doing illegal things, but that's just another risk to take. You already want to take the risk to try unregulated products/services on your own body, why fret over taking the risk of going against government?

If anything, the fact you'll face consequences would mean you have individual freedom - you and you alone bare the responsibilities of your own choices and actions. It's what libertarians want right? People make their own choices and own up to them, not have some nanny government subsidizing the risks and liabilities for you.

Re:And not a thing will be done about it

[bluefoxlucid]

Oh psh. Medicine is supposed to cure or lessen peoples' ailments, and medical research is supposed to further our ability to do just that. These aren't bankers giving loans at 30% interest to people who need money right now or they'll be out on the street, coming back to leech away their last life savings and take their homes in foreclosure. When medical researchers find someone that desperate, they have three possible outcomes: refuse experimental treatment and die now; accept experimental treatment and die now; accept experimental treatment and get miraculously healed for free.

Journey before destination, always. But when it comes to medical research, the service in trade is valuable experimental data. This doesn't cost a dying man anything: if the experiment ends in your death, what have you lost? Butchery it may be, but butchering the young and healthy would be functionally useless. We want to butcher the old and sick.

Re:And not a thing will be done about it

[h4rr4r]

I said nothing about safety, only labeling.

If they make claims they should have to prove them.

Otherwise I can sell a drug that claims to cure your inability to read, then convince your doctor by sending over a hot pharma rep and charge you thousands for sugar pills.

Re:And not a thing will be done about it

[h4rr4r]

They do not mean the same thing at all.
No one harvested a fetus via abortion then took stem cells from it.

Re:And not a thing will be done about it

[h4rr4r]

Normally early trial patients are paid, they normally have no medical problem to treat they are safety Guinea pigs. Clearly the doctors you are talking about are skipping some steps.

Re:And not a thing will be done about it

[jellomizer]

Because not everything boils down to Genetics. The environment has a major factor too.

Re:And not a thing will be done about it

[Coffeesloth]

I agree with you and I have not had the time to read every comment but has anyone considered that this ruling now means anyone that travels across a state line can now be regulated as interstate commerce?

It is a close question but ultimately the Court concludes that the Regenexx Procedure is subject to FDA enforcement because it constitutes a “drug” and because a drug that has been shipped in interstate commerce is used in the solution through which the cultured stem cells are administered to patients.

...your stem cells are a drug that has been shipped in interstate commerce. This had better be overturned or there could be taxes for everyone traveling out of state.
I wonder how this affects blood drives. If the occasional stem cell gets inadvertently transferred in the blood to another person does that constitute dispensing a drug without a license?

Re:And not a thing will be done about it

[englishknnigits]

You aren't too far off, Paul Krugman is another good example of what you are talking about. Although he usually replaces "the free market is so wonderful" with "the government is so wonderful." Part of the problem with economics is that it is in the same category as psychology and other "soft" sciences. It is impossible to change a variable and hold everything else constant within a group of people or an economy (really just a group of people and their interactions) so every experiment is different and they are rarely repeatable. It is also quite difficult to do things like create great depressions, let alone with similar causes and attributes, and try to fix them by different means to see which approach is most effective.
As for problems the FDA has caused, in 1998 the average approval time for a drug was 7.3 years. If it was a life saving drug, that would mean deaths during those 7.3 years even if the drug was eventually approved. If you sum up the deaths and suffering from delayed drugs (100% of drugs) then that is undeniable harm the FDA is causing. Either the drugs aren't effective or the FDA is causing harm by delaying them. One of those two things has to be true. You don't need specific examples for that to be undeniably true.

Re:And not a thing will be done about it

[kenorland]

You said nothing about labeling, and you were responding to a thread on regulation. But I'm glad that you now agree with me that regulation is too strong and that the FDA's powers should be limited to labeling in many cases, leaving the decision up to the end user. Unfortunately, that's not the case right now.

Re:And not a thing will be done about it

[nbauman]

Nope. There's a third option.

Most drugs aren't life-saving. Even a successful cancer drug like bevacizumab (Avastin) extends life in metastatic colorectal cancer by about 3 months, as I recall. (It costs $100,000 for that treatment, so you're buying life at $400,000 a year.) It's very frustrating to read the New England Journal of Medicine about a successful new drug that only extends median survival from, say, 12 months to 16 months. So people with metastatic colon cancer haven't been dying over 7.3 years for lack of a new drug. They've lost (at best) 3 months.

A lot of the new drugs (like Avastin) have life-threatening adverse affects. For example, there are anti-immune drugs that are used to prevent rejection in kidney transplants. If you don't give enough, the kidney is rejected. If you give too much, the patient can't fight off infections and dies. There's an anti-immune drug for multiple sclerosis that is very effective against multiple sclerosis, but frequently allows a normally dormant virus to activate with an incurable fatal brain infection.

After the Food and Drug Administration Safety and Innovation Act was passed, which allowed pharmaceutical companies to pay user fees to get their drugs approved more quickly, the FDA did approve drugs much faster. However, they also approved a lot of drugs that turned out to kill more people than they saved, like Rosiglitazone and Vioxx.

Most of the doctors who follow this issue, who made FOIA requests and read the internal FDA debates, believe that the FDA approved these dangerous drugs because they were under more pressure to approve new drugs faster. Vioxx is a good example. It wasn't a life-saving drug; it was a treatment for the pain of arthritis, and wasn't any better than competing drugs. They got it to market faster and it killed people.

When we loosen regulations, and pressure the FDA to approve drugs faster, we get more drugs that kill people and we don't get any miracle drugs that save lives.

(Can't blame the Republicans for this. The SIA was a bipartisan bill, BTW, and some Republicans actually opposed it.)

This isn't a randomized controlled trial, It's more like a historical control. But it's the best evidence we've got. And it's better evidence than Peltzman had.

And besides, when we do get a new drug that's really promising, the FDA puts it on a fast track and approves it as quickly as possible -- consistent with careful science. Their average approval time is under 7 months. http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm (And I don't know where you got that 7.3 years from. This table says it took 1 year in 1998. You may be counting the entire development time from patent to FDA approval.)

I think economists like Peltzman get things completely wrong because they create a free-market economic model for widgets and plug drugs into their model. I once read a book called Structure of the Chemical Processing Industry. They made the point that products aren't widgets. The pharmaceutical industry has a different structure than the automobile industry. Significantly, most customers don't have enough information to know whether a drug is effective. Significantly, the human (or mouse) body is much more complicated than cars, and there's no predictable way to find new drugs. Significantly, you can spend billions of dollars (as we did with the AIDS vaccine), and get nothing. Significantly, most pharmaceuticals depend on basic research by scientists who usually don't profit directly from the final drug. Significantly, most of that basic research is funded by the government.

Peltzman's theories about how the free market works don't correspond to reality. That's the point in science. You do need specific examples -- empirical evidence.

Speaking for Krugman, he never said, "the government is so wonderful"

Re:And not a thing will be done about it

[englishknnigits]

That's not a third option, that's an additional point.
Good things the FDA does:
A. Disallow bad drugs.
Bad things the FDA does:
B. Disallow good drugs. (or discourage their development)
C. Delay the use of good drugs.

"A" is obviously a good thing. "B" is obviously a bad thing. "C" is a bad thing whether you could have "only" given someone 3 more months to live or you could have cured their disease and prevented their death from it. Yes, there are varying degrees of "C" but it is a negative effect (bad thing) no matter how you spin it.

The question is, do the positives ("A") outweigh the negatives ("B" and "C").
Citing specific examples of "A", "B", or "C" does not prove anything other than they happen. I can't see how there would be disagreement that they all happen/exist. The disagreement is about the frequency and impact of "A", "B", and "C". To prove anything about the net effect, you would need to look at every drug ever approved, disapproved, or not developed due to the FDA process and sum of their net effects.

As for Krugman, I can't help but think you are trolling by actually googling "the government is so wonderful." Read his articles regularly and you will understand that is the message he is sending, not the exact phrase he is uttering. Yes, it is an overstatement but so is "the market is so wonderful." As a side note, Friedman (and other libertarians), also think the government does (or should do) important things that the market can't do. An environmental example is at ~8:50 into this video: http://www.hoover.org/multimedia/uncommon-knowledge/26936

Re:And not a thing will be done about it

[khallow]

You already want to take the risk to try unregulated products/services on your own body, why fret over taking the risk of going against government?

Going to jail and losing your stuff is a pretty hefty risk.

Re:And not a thing will be done about it

[tragedy]

Abortions? I don't think too many researchers (if any at all) were using stem cells from aborted fetuses for research. The embryonic stem cells were coming from medical waste from in vitro fertilization clinics. For every successful implantation, multiple embryos are created and then discarded.

Re:And not a thing will be done about it

[nbauman]

To prove anything about the net effect, you would need to look at every drug ever approved, disapproved, or not developed due to the FDA process and sum of their net effects.

There certainly are lots of doctors who have carefully followed every drug approved, delayed or not developed over the last few decades. (The FDA almost never rejects a drug; they usually say that more evidence is needed. If a company can't get evidence that the drug works, then they drop the drug because it's a market failure, not because of the FDA.)

I've read articles by those doctors in the medical journals. A cardiologist, for example, doesn't have to look up the drugs. There are cardiologists who have followed every prospective and approved heart drug during a career of 20 or 30 years. They have a pretty good idea of what works and how well it works, based on their own experience and on the clinical trials. They have well-established ways of quantifying the benefits. (Peltzman and the other U. Chicago economists have said that doctors are able to assess the value of new drugs in the marketplace alone, even without the randomized, controlled studies that the FDA requires.)

Look up Steven Nissen's writing, and Marcia Angell's writing. Cardiologists like Steven Nissen point to many FDA-approved drugs over the past decades that have done more harm than good (in terms of lives saved vs. lost), and published the kind of analysis that you describe in the New England Journal of Medicine and elsewhere. He thinks that the number of drugs that had to be withdrawn for safety reasons has increased as a result of the user fees, and that the FDA is approving too many dangerous drugs.

As for drugs in development, the cardiology meetings are full of reports on promising new drugs, and there are lots of cardiologists who follow them from tissue culture to mice to human trials. Nobody is hiding these things. I haven't seen any mainstream doctors complaining that there are promising drugs that aren't being developed, for FDA reasons or any other. That's something that conservative economists say, but it's not something that pharmacists and doctors say.

I can't convince you of this. You just have to go to the medical literature and read the articles yourself. I can't summarize 25 articles for you. And I don't think that would convince you. All I can say is, look at the facts.

As for Krugman, I can't help but think you are trolling by actually googling "the government is so wonderful." Read his articles regularly and you will understand that is the message he is sending, not the exact phrase he is uttering. Yes, it is an overstatement but so is "the market is so wonderful." As a side note, Friedman (and other libertarians), also think the government does (or should do) important things that the market can't do. An environmental example is at ~8:50 into this video: http://www.hoover.org/multimedia/uncommon-knowledge/26936

Yes, it is an overstatement. Krugman is a liberal, not a socialist. Even the socialists and Communists (in China, Cuba, etc.) don't believe that the government can do everything. The issue is whether the U.S. government is too big, and should be starved to death (no exaggeration) as the Wall Street Journal editorial page and Grover Norquist say, or whether it's already smaller than the optimum efficient size. Krugman says that taxes particularly on the rich are lower than they've been in a century, lower than they've been during the times of greatest industrial development, and lower than any other developed country. He says that in the past government has invested in things like the Erie Canal that private operators wouldn't have invested in, that returned their investment many times over, and it would be good for the economy to make more investments like that right now. I agree. If you want more new drugs, increase the budget of the National Institutes of Health (which the Republican congress has reduced, in constant dollars). Don't weaken the FDA safety regulations; that won't raise any incentives for new drugs.

Interesting side effects

[vlm]

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.

Re:Interesting side effects

[Baloroth]

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:Interesting side effects

[dgatwood]

But it is none the less weird that if dialysis was invented today, it would be considered a drug under than doctrine.

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....

Re:Interesting side effects

[jbeaupre]

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

[Trepidity]

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.

Re:Interesting side effects

[h4rr4r]

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.

Re:Interesting side effects

[h4rr4r]

So then take it to SCOTUS.

People smarter than you have tried and failed.

Re:Interesting side effects

[roman_mir]

So that shows another reason why you are not very smart. SCOTUS is in on the deal, that's why they still pass laws as supposedly Constitutional based on very narrow and specific interpretation, while they are supposed to be looking at the spirit of what the law is intended to do and then based on the past performances of the government abuse of SCOTUS narrow decisions that are generalised to grab power that the government isn't supposed to have, and SCOTUS should deny the government all new laws. They are supposed to protect the Constitution, it's their mandate. Not to protect the power, not the government, not Senate, not Congress, not POTUS and not even the people, SCOTUS is there to protect one thing: the Constitution, and it is failing miserably and not because they are not smart enough for the job, they are doing it to be popular with the government, media and the crowd.

Taking this to SCOTUS is a worthless idea from every perspective.

Re:Interesting side effects

[Crosshair84]

Equivocation logical fallacy on your part.

http://i.imgur.com/GLV7s.jpg

The point being made is that "Incomes" was defined by the SCOTUS as "Profits". The government and you are using a different definition of the word, "gross wages" which the SCOTUS rejected.

Gun control advocates do the same thing in regards to the second amendment. "Well regulated" in that usage means kept in proper working order. They deliberately use a different meaning of the word to mean "Heavily government controls." A very Stalin-esque thing to do.

Just because people like Irwin Schiff are right on the issue doesn't mean they are going to win. It was wrong for whites to take the Indians land, doesn't mean it didn't happen. The holocaust was wrong, that didn't stop the German government from doing it. Interring Japanese-Americans and effectively stealing their property was wrong, but the US government still did it anyway. They fact that they ARE getting away with it doesn't make it right either. If it did then you would have to say that Stalin murdering tens of millions of people was right because he got away with it.

A rather logical move

[Schmorgluck]

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:A rather logical move

[nbetcher]

Food and DRUG Administration. Enough said.

Re:A rather logical move

[Seedy2]

Blood, platelets, and bone marrow have all been under the FDA's control for decades, why would stem cells derived from those products not be?

Re:Everything

[MozeeToby]

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?

Re:Everything

[macbeth66]

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.

Good thing??

[ZenDragon]

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.

Re:Good thing??

[Anonymous Coward]

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:Good thing??

[the eric conspiracy]

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.

Re:Everything

[smooth wombat]

Thus the FDA can regulate everything.

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 don't have to show their stuff works under standard, clinical trials and so get to fleece people of their money with miracle cures, ala Kevin Trudeau.

Right?

[J'raxis]

The FDA, a government bureaucracy, has "rights"?

Re:Right?

[Schmorgluck]

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.

Re:Right?

[CptNerd]

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...

Re:Right?

[the eric conspiracy]

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.

Re:Right?

[P-niiice]

No, no you're right. Plus, since I'm only 3/5 of a person, the medicine wouldn't hurt me as much if the claims were false!

Re:Right?

[khallow]

It's worth noting that the judge uses the word "rights" only once in his ruling and that was used in the proper constitutional sense of the word. Just some rather careless reporting.

Re:Right?

[Schmorgluck]

Ah, worth noting indeed. I'm not familiar with English legalese, and IANAUSC; so I may have got a bit carried away in general concepts.

Would you be so kind as to point me to some reliable and layman-accessible resource about that proper constitutional sense of the word "right"? No sarcasm, I'm genuinely interested.

Re:Right?

[khallow]

I'm not an expert in the area, but I suggest Wikipedia, not for the articles (though those are well done), but for the bibliographies. The articles on the US Bill of Rights and natural and legal rights have a considerable breadth of material for your enjoyment.

For me, the language of the actual Constitution is instructive. The original Constitution only uses "rights" once with respect to the IP of authors and inventors. The Bill of Rights (which was an immediate addition to the Constitution and IMHO properly thought of as part of the original Constitution) and subsequent amendments use "rights" on occasion, usually in connection with "the People", "citizens", or voters. Only once in all that mess does any government entity have a "right". In Amendment 20, the House of Representatives is said to have "right of choice" when they are authorized by the Constitution to appoint a US President. But the amendment doesn't actually grant that.

For the most part, the People, citizens, and voters have "rights" and government bodies have "powers". Further divisions create the federal government which has "enumerated" powers and the state governments (which supposedly have broad powers constrained only by the Constitution and the powers it grants the federal government) and the three famous branches of the federal government (legislative, executive, and judicial) which further divide up federal level political power.

Past that, things get tricky. It's generally agreed that rights tend to override powers and that most of government's authority is limited, but even that is in some dispute and there's little agreement past that. Even if one attempts to preserve the strict meaning of the Constitution (which is frankly, a bit more consistent than interpreting it in one's favorite way), we still have the problem that there was considerable disagreement at the time of the creation of the Constitution as well. So there's no particular meaning of the parts of the Constitution or how things were to operate to the founders any more than there's a particular meaning to us today.

An interesting study is the evolution of the US federal court system. In the beginning, there was just the Supreme Court. Congress created a network of subordinate courts to lessen the load on the Supreme Court. The Supreme Court also carved a more dominate role for itself as the official arbiter of what is and isn't Constitutional as well as occasional rulings bordering on legislation (such as corporate personhood or modern civil rights).

Equal time

[Empiric]

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

[drunken_boxer777]

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.

Re:It's about time

[kimvette]

conditions like joint pain don't exactly warrant unproven treatments in the same way that certain cancers might.

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.

Re:It's about time

[randallman]

The theory of how this works is that it is a purified version of microfracture, 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 sense and Regenerative Sciences is claiming something like an 80% success rate. Microfrature was controversial at its infancy, but the results spoke for themselves and the sports industry took notice and became early adopters. A similar thing is happening now with stem cell therapy as athletes have taken notice (Bartolo Colón, Jarvis Green). I've been watching Regenerative Sciences for 3-4 years looking for the negative reports to come on (fraud, etc) and haven't seen them. Instead I've seen them rise in popularity, branching out and publishing (results as well as safety and complication data). They're claiming very good results and behaving responsibly as far as I can tell.

Re:It's about time

[Nexus7]

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 kooks, for that matter) - just because they can't see why the FDA is correct must mean the FDA is wrong.

And there's also this anti-government/libertarian sentiment (why do we need medical regulation, why do we need the dept of education, etc.). In some cases, there is over-regulation and some times regulation does lead to beneficial drugs getting to market later than otherwise, but the FDA exists because the record of the free market in medicine has only debilitating injury and death to show for it.

And I think we're finding this out with there off-shore stem cell facilities too. Only the failures never make it to the marketing material, so these treatments always work, so why should the FDA not let everyone get the benefit, right?

Re:It's about time

[h4rr4r]

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.

Re:It's about time

[drunken_boxer777]

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 versus safety. Any treatment for a lethal condition is granted far more leeway in safety profile and adverse events by the FDA, physicians, and patients than a non-lethal condition. Joint pain is non-lethal. Untested therapies, like stem cell therapy, are unwarranted in treating joint pain: the unknown potential for serious problem (cancer) is not offset by the upside of successful treatment. In cancer, you have compassionate use programs that allow drugs to be used on types of cancer they've never been tested in. Why? Because the upside (living) outweighs all the horrible side effects these drugs typically have.

Don't get me wrong, opioids are a real problem. Joint pain can be debilitating. But is curing it worth risking cancer or some unknown serious adverse event? Well, to reasonably answer that question we need to conduct clinical trials to determine the efficacy of the treatment and the type, severity, and frequency of adverse events.

But until there is any scientific proof that this procedure works, it is best if the average person does not have access to it.

*I am very hopeful about the promise of stem cells, but believe they should be tested properly.

Re:It's about time

[h4rr4r]

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.

Re:It's about time

[drunken_boxer777]

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.

Re:It's about time

[drunken_boxer777]

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 should blindly submit to the authority of scientists or experts, but any well-educated person knows when they don't know enough.

As an aside, don't get me started on the anti-vaccine crowd. Sadly, ironically, and for our benefit, their genes don't always get passed on more than a generation.

Wat?

[Quiet_Desperation]

Quick! I need an ideological purist to tell me what to think about this!

Re:Wat?

[Anonymous Coward]

Quick! I need an ideological purist to tell me what to think about this!

As a Free Thinker, I can only advise you to educate yourself as best you can and come to your own (possibly incorrect) conclusions. Sorry.

Re:Wat?

[dkleinsc]

You should love/hate this without doing anything to analyze it, of course!

Re:Everything

[cayenne8]

Why do we have people running around defending hack doctor's rights to inject them on unsuspecting and uninformed patients?

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 out there are dedicated to helping people...their main job.

They'd have to be...with all the crap they have to put up with local hospitals, govt regulations, constant litigations by people trying to get rich quick...they'd have to love the job and be dedicated to it to stick with it.

You're not likely to be rich being a Dr like in the old days...

Too bad the enormous evidence isnt cited here.

[Anonymous Coward]

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.

This is what Kobe an many other athletes have done

[danparker276]

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.

Basic truth: most new drugs don't work

[Animats]

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.

Re:Basic truth: most new drugs don't work

[danparker276]

Yeah, but this really isn't a drug. There are many other surgical procedures where they use your own body parts or fluids. Athletes are doing it now, so there's your clinical testing. We'll know the results in a few years. I personally wouldn't get it done until I see more positive results like Kobe and Bartolo Colon.

Healthcare a right?

[snsh]

The "right to healthcare" officially does not exist as long as government can totally block you from getting the treatment you want.

Re:Healthcare a right?

[Seedy2]

"Want" has nothing to do with medical treatment.
A doctor can frequently determine what you need.
Unless you are a doctor you are unlikely to know what you need.
Want is a word that gets used when people listen to advertisers.
One of the many reasons I think ads for prescription meds don't belong anyplace except medical professional publications.

Re:Healthcare a right?

[snsh]

"Unless you are a doctor you are unlikely to know what you need."

A blanket statement like that is clearly not true.

Re:Healthcare a right?

[Seedy2]

So I sacrificed a little precision for brevity...

Barring chronic conditions, it is clearly true. (a patient who takes a drug every day know they need it)
Yes, if I have a cold I need decongestant, as long as there are no other issues to complicate the matter.
Yes, it's a blanket statement, that is true in almost all non-trivial cases.
Else being a doctor would require considerably less schooling.

Re:Everything

[kenorland]

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

Care to cite any studies/evidence?

Re:Big brother knows best ?

[ajlitt]

I see a well appointed cubicle farm and some trees out the window.

Why not an advisory board instead?

[trout007]

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.

Regulate happiness next?

[Liamecaps]

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."

This is completely off-topic

[quax]

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?

Re:This is completely off-topic

[mcgrew]

I'm glad you enjoyed it. It's still a work in progress, that's mostly what I've been putting in my journal lately.

Re:Power Tits!

[UltraZelda64]

I know that was a troll post, but I have to admit it was so damn random and funny I just had to laugh.

this ruling is mass murder

[Anonymous Coward]

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?

yes, yes...shabaz

[slick7]

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?

Re:Everything

[khallow]

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?

If you know the above, then you are informed. There's always things that even the doctors don't know about. If that uncertainty is enough to disqualify someone as an informed patient, then to be blunt, there is no such thing as an informed patient and we need to come up with a new standard of informed consent that reflects that.