Doctors Skirt FDA To Heal Patients With Stem Cells

kkleiner writes "For many years countless individuals in the US have had to watch with envy as dogs and horses with joint and bone injuries have been cured with stem cell procedures that the FDA has refused to approve for humans. Now, in an exciting development, Regenerative Sciences Inc. in Colorado has found a way to skirt the FDA and provide these same stem cell treatments to humans. The results have been stunning, allowing many patients to walk or run who have not been able to do so for years. There's no surgery required, just a needle to extract and then re-inject the cells where they are needed. There has always been a lot of hype around stem cells, but this is the real deal. Real humans are getting real treatment that works, and we should all hope that more companies will begin offering this procedure in other states soon."

Comments

Implants are a thing of the past?

[losfromla]

I imagine both sexes have something to look forward to from this exciting development in the self improvement industry.

Re:Implants are a thing of the past?

[repka]

IMO parent has a point, what's flamebait about it?

Re:Implants are a thing of the past?

[Golddess]

While it may not be flamebait, it's probably at least offtopic. I'm not so sure stem cells could "cure" what is purely an aesthetic thing (breast/dick size). At least it sounds to me like that is what OP was hinting at.

Re:Implants are a thing of the past?

[mcgrew]

I have a device implanted in my left eye that not only allows me to see, but gives me better than 20/20 vision at all distances. Ther's at least one other cyborg here with a cochlear implant. There are implanted pacemakers, implanted filibrators, implanted joints, all sorts of cybernetic implants. You will be assimilated, resistance is futile.

Your attempt at humor is futile as well. Going for "funny" is dangerous to your karma, unless your karma's alrady excellent.

Re:Implants are a thing of the past?

[mcgrew]

Do your worst. It's doubtful you'll do much more than bury a few comments, and you may not even succeed at that.

Re:Implants are a thing of the past?

[SlippyToad]

I have devices in both my eyes that allow me to see at better than 20/20 vision. They're flexible plastic discs that I attach to my corneas.

Every two weeks I throw them away and get a new pair.

I never knew I was a cyborg!

Re:Implants are a thing of the past?

[Nefarious Wheel]

I have devices in both my eyes that allow me to see at better than 20/20 vision. They're flexible plastic discs that I attach to my corneas.

I think GP was referring to acrylic replacement lenses, the sort that replace your own when they turn yellow and opaque like an old convertable car's plastic back window. They reside behind the pupil, and are a cure for cataract blindness. I wear a pair of those too. Visual acuity with them is astounding, better than before I went blind.

Re:Implants are a thing of the past?

[srothroc]

Yeah, I have a cochlear implant, though I'd love to be able to hear with just one simple injection. The cochlear implant is large, annoyingly bulky, takes money to maintain, vulnerable to weather, and not exactly great for any kind of impact sport (including running quickly).

Re:Implants are a thing of the past?

[longhairedgnome]

You would be surprised at how few noncyborgs running around

Re:Implants are a thing of the past?

[jamesh]

once I get a girlfriend, I mean.

You could always create one out of your own stem cells. Technically she'd be your twin sister, but God made Eve out of Adam's rib so you can at least cite precedent.

Re:Implants are a thing of the past?

[mcgrew]

I think GP was referring to acrylic replacement lenses, the sort that replace your own when they turn yellow and opaque like an old convertable car's plastic back window.

Exactly, and I'm not sure the definition of "cyborg" would even cover the old monofocal IOLs. The new ones sit on struts, and actually focus; they're clearly "devices", as they move, powered by your normal focusing muscles. You don't even need reading glasses with them.

Re:Implants are a thing of the past?

[mcgrew]

True; most folks have at least one cyborg grandparent.

cancer worries

[drDugan]

I'm bullish on these techniques, and feel strongly that they will usher a new wave of medical breakthroughs, redefinitions of disease states, and significant increases in longevity.

However, there are real concerns about neoplastic growth from stem cells - that older cell used to create "autologous" transplants (cell lines that start from the given subject and are re-injected back into that subject) may have damage that leads to uncontrolled growth. Real safety testing is very, very difficult to do in a controlled way.

Re:cancer worries

[ColdWetDog]

Might be the reason you can get away with doing things on horses and dogs. For animals with shorter life spans, the risk of a cancer might be lower. Hard to tell.

Also hard to tell if this doc is just another snake oil salesman or is God's Gift to Medicine. FTFA:

Caption from a pair of MRI images: A severely damaged knee healed to a remarkable degree. Must be stem cells.

Right. Must be stem cells. Couldn't possibly be natural healing of an acute injury - which is exactly what it looks like. Seems to be a T1 weighted image which shows localized edema. Wait awhile and magically the body heals itself. Take another MRI and profit!

Nice thing about bypassing the FDA - you don't have to prove safety or efficacy. Just take people's money.

Re:cancer worries

[Yvan256]

Nice thing about bypassing the FDA - you don't have to prove safety or efficacy. Just take people's money.

So you're saying that on top of it all, it's a green process? Hurray!

Re:cancer worries

[JustinOpinion]

I have to agree. I'm a big believer in stem cell research, and think that it will play a crucial role in future life-saving medicine.

However, I also know researchers at the FDA, and these guys are not dumb. If they are cautious about approving a new procedure, it is usually because there is insufficient data to really declare it safe. In other words, more research is certainly needed before stem cell therapeutic techniques become widespread. Giving someone back their ability to walk is fantastic--but rather less so if we discover in 5 years of lethal side-effects.

TFA does link to a study published by the doctors offering these treatments. They describe that for the 227 patients studied, none had neoplastic complications. This is encouraging, but again I think more research is needed: first these kinds of results need to be double-checked by others, and secondly over longer timespans (the study in question only followed patients for ~1 year).

Re:cancer worries

[DesScorp]

This may have a wonderful ending, and maybe it wont, but you know, there's a reason that the FDA takes a long time to approve treatments. You might want to consider that before you try to beat the system, so to speak. Now, if you're going to definitely die without it, then I could see taking the risk. Otherwise, I'd be vary wary.

Re:cancer worries

[Princeofcups]

Real safety testing is very, very difficult to do in a controlled way.

The only way to test on humans is to actually test on humans. People are always willing to take a risk when they are living with constant pain, as are these people. I wonder if the real culprit on the delay is the insurance companies? Or is it the established medical community who are not tooled up yet for maximum profit on the procedure?

Re:cancer worries

[Hadlock]

I too am a bit worried about the cancerous implications of this. Of course, if you're age 40+ have a gimp leg (knee), and you gain use of it for 10 years, but then have to have it amputated due to it going cancerous, is that better or worse than hobbling about during the last active years of your life? That's a hard decision to make, but I think I would rather have 50 good years with a leg and lose functionality later, than lose most of the functionality now and be hobbled for the rest of my life.

Re:cancer worries

[natehoy]

Well, we apparently have a pool of willing volunteers who are knowingly accepting medical treatment from a doctor that is not FDA approved. You know for sure this guy's malpractice insurance isn't going to cover it if his patients all end up with sudden cases of terminal cancer, and in the meantime his procedures on willing subjects are going to give the FDA tons of useful data. So, studies are being done, no worries about malpractice insurance rates going up. Sounds like a winner to me.

I just hope the risks have been explained to the patients who are receiving the treatment. I mean, REALLY explained. Not in terms of the vacuous testimonials on this site, but in terms of "we don't know how big the risk really is yet, because we don't do this a lot in humans."

I know a few people who are suffering from severely reduced mobility (permanent crutches) who get far less exercise than they would if their legs worked properly. If you told them there was a $10,000 cash treatment that gave them an 75%+ chance of significant improvement within a year year, but a chance they could eventually develop cancer, I expect at least a couple of them would go for it. One of them is in her 40s and due to weight (brought on by 15 years of waiting to qualify for surgery) is a relatively poor candidate for knee replacement. She can't exercise because she can barely get out of bed, and she can't get surgery because she can't exercise (any movement = pain), so she's in a nursing home. I think she'd gladly trade a risk of dying of cancer a couple of decades from now for the ability to get some exercise and at least enjoy those decades.

Re:cancer worries

[physburn]

Patients of the company probably know that they be guinea pig, which won't be much consolation if the come down if cancer. Stem Cell Medicine does need the safety testing, it won't be until thousands have had it and aged, till we know how safe it is. I hope safety fears don't put people off research stem cell, almost all of us, could potentially use it to slow the aging process. There must be ways to test for damaged cells, and perhaps even engineer for reduced rates of cancer in the cell lines to be transplanted.

---

Stem Cells Feed @ Feed Distiller

Re:cancer worries

[Idiomatick]

This. People should be informed and make a decision. You wil probably be able to walk again but there is a slight slight chance of getting cander in a few years which may or may not be treatable. I imagine a large number of people would be signing on the dotted line.

Re:cancer worries

[Aeros]

Insurance companies sometimes seem to require as much data (possibly more) than the FDA does when it comes to approving things. There have been a few things I looked at having done on my back but since they have only been around for 5 years in the US (20+ in Europe) they were still waiting to cover it.

Re:cancer worries

[Idiomatick]

For animals with shorter life spans, the risk of a cancer might be lower. Hard to tell.

Why not allow older people to test it then? Better to risk a year or two of lost life.

Re:cancer worries

[ColdWetDog]

Quite possibly. But without decent data you won't be able to make an informed decision. Unless this guy actually publishes something, one ought to be very suspicious. This is an extraordinary treatment. Extraordinary claims (should) require extraordinary proof.

Re:cancer worries

[vlm]

Isn't it much easier to cut a cancer out, than to wish flesh into existence? Cancer of the tendon or whatever isn't all that common anyway.

Now realize the cancer rate will NOT be zero, because the cancer rate of human flesh, natural or otherwise, is not zero. Therefore people whom get stem cell therapy will get cancer and die. Therefore, their Drs will get sued out existence. That will be the problem.

Re:cancer worries

[BobMcD]

I'd point, though, that patients are not dumb either. If they're being told the risks, including the fact that the FDA hasn't signed off on it yet, then I see absolutely no problem with it.

Re:cancer worries

[MozeeToby]

Repeat after me: "You do not need excercise to lose weight". Calories in Calories out. Being bedridden might reduce calories out to 1200 or so, but you can always eat less. It might not be enjoyable, but if the choice is being hungry every day for 6 months or being bedridden for the rest of my life, I for one would rather be hungry.

Re:cancer worries

[gangien]

These are all reasons why i say the FDA causes more harm then good.

People should be free to make their own choices. hell, even if we keep the FDA, people should allowed to use things not approved by the FDA.

But people always look blankly at you if you suggest the FDA doesn't really protect you, and we should get rid of it. (or in slashdot's case, it's mock you or mod you down).

Re:cancer worries

[natehoy]

Except that injecting stem cells doesn't necessarily mean all of them will stay nicely in the area where you injected them. If they're naughty enough to turn into cancer cells, you can bet they won't be nice enough to stay in place.

So, would you risk not only losing that leg, but your liver as well? How about an unknown risk of a fully-metastasized cancer all through your body? Does that change the equation?

I imagine stem cells would make an easily-metastasized base from which to develop cancer. I'm not a doctor, but if you ask a competent one they'll tell you they don't know yet either. It hasn't been fully tested in humans. Hence why the FDA is freaking out.

And, to head off the inevitable question of "well, what's the risk, then?".. Medical science appears to lack that information right now. This is why the FDA has not yet approved this procedure - they don't know the risks and they need human trials, and getting human trials on risky procedures is HARD.

These patients are going to find out for the rest of us. We should thank them for that. Hopefully they understand what they are getting themselves into. I really hope this pans out as a viable procedure. There's a good chance it will. And it could help so many people.

But right now this procedure could just as easily be a relatively short term death sentence for an unknown percentage of these patients.

THESE are the human trials. They are happening right now.

Re:cancer worries

[vlm]

but a chance they could eventually develop cancer

she'd gladly trade a risk of dying of cancer a couple of decades from now

If they're alive, they already have a chance to develop cancer.

Everyone alive now, has a risk of dying of cancer a couple decades from now, unless they already have a short term terminal diagnosis or are very elderly (someone in their 90s now will almost certainly will not live another half century, etc)

Look at how effective printing "The surgeon general has determined that ... a dramatically higher chance of cancer" on cigarette packs has been.

You can scare people with one per ten million sticking accelerators. You can scare them into anything by telling them there's a terrorist hiding behind every tree stump. They even verbally say they're scared of cancer because they know its the culturally correct thing to say. But in practice, virtually no healthy, non elderly people are genuinely scared of cancer to the point that it'll affect their decisions, even if their relatives die of it.

Re:cancer worries

[Tacvek]

I'm wondering about that. Bone marrow by nature is about as highly protected as any cell source from outside forces that tend to cause mutations, such as high energy photons (UV light (skin cancer) though gamma rays at the very least).

as for internal forces, I'm not aware how well carcinogens can penetrate bones, but I would suspect it is harder to do so then to get into most other tissues.

Thus I would tend to guess that excepting cells that have ceased dividing, cells in bone marrow probably have fewer mutations than most other cells.

That would imply that injecting them elsewhere would not increase the risk of cancer, as the other cells in the injection area likely aready have more cancer friendly mutations than the stem cells.

Now, I do see several areas where this logic could go wrong.

Perhaps the marrow is more likely to be mutated, as a result of carcinogens that make it in to the marrow are unlikely to leave, so they continue to damage cells.

Perhaps the dozen to two dozen generations of cell growth used in this procedure significantly overcome any additional mutation protection bone marrow may provide. After all, ever cell division is another opportunity for mutation.

Perhaps these cells being normally protected by the bone are more susceptible to external mutation than other cells are, thus the transplanting being a danger in that regard, at least until the stem cells fully specialize.

Is there any evidence or reason to believe one of those three cases, or something similar is true? If not, I'd tend to question worries of cancer.

Re:cancer worries

[Khyber]

"If they are cautious about approving a new procedure, it is usually because there is insufficient data to really declare it safe."

That doesn't stop them from taking bribes and pushing bullshit pharmaceuticals into the market without required testing - Vioxx, anyone?

Re:cancer worries

[CrimsonAvenger]

I just hope the risks have been explained to the patients who are receiving the treatment.

That would be nice.

It would be even nicer if we had any way of knowing whether the patients "who are receiving the treatment" are actually receiving the treatment....

Re:cancer worries

[c 0xFF]

The problem with choice is information and education.

I, for one, and glad that the FDA exists to protect me, because I know absolutely nothing about medicine. I wouldn't have guessed on my own that this treatment might cause cancer, for example.

Now, I'm not saying the FDA is perfect by any means. But given the number of people that use worthless natural/homeopathic/eastern/etc remedies, I foresee a future with rampant disregard for proper medical science were we to simply throw out the FDA.

With proper disclosure, I suppose most any treatment should probably be allowed. But who do you trust more: the government (run by politics and bureaucracy) or companies (run by greed and greenbacks)?

Re:cancer worries

[thedudethedude]

well, it's a good thing we have objective journalism like this piece. Oh wait...

Re:cancer worries

[Xtravar]

Indeed, am I the only one thinking that maybe she should be hooked on hydrocodone instead of Ho-Hos? There are plenty of reasons for over-eating, and one of them is dopamine insufficiency. Since she's in pain, she could easily get a prescription for some good narcotics and solve both problems.

Re:cancer worries

[cyberkreiger]

It isn't just as simple as that, see http://www.youtube.com/watch?v=AVvZP2av5Mk

Re:cancer worries

[cthulu_mt]

but there is a slight slight chance of getting cander

If there were a chance I'd personal pay for the treatment of the entire US Congress.

Re:cancer worries

[fuzzyfuzzyfungus]

The trouble is that, unless somebody bothers to do a real study(and no, filling a brochure with flattering anecdotes doesn't quite cut it) nobody is informed.

History is full of novel treatments that turned out to work, that is why we aren't still sacrificing chickens to Aesculapius; but it is even fuller of treatments that didn't work, were actively counterproductive, or were initially promising but didn't pan out.

Unless these guys step up with some science, I'd say that this article is just a libertarian snake-oil infomercial. "The Exciting Cure that the fascist FDA DOESN'T WANT YOU TO HAVE!!!!"

Re:cancer worries

[assert(0)]

1. What makes you think fasting is any more enjoyable than light to moderate exercise? Repeat after me: "Starvation is painful." With exercise you get pain modulation in the form of endorphines. Fasting ... well, no such luck... Your genes are SCREAMING at you to FEED. Constantly.
2. How are you planning to avoid gaining when going back to your body's set-point caloric intake after fasting for 6 months?
3. The less you eat, the smaller the margins and the higher the risk of not getting the nutrients you need. And no, supplements will not magically fix a deficient diet.

Re:cancer worries

[Beezlebub33]

They can't be told the risks, because nobody knows what the risks are. Just saying "Well, it might cause cancer someday" isn't telling someone the risks. What sort of cancer? With what probability? What are the chances that it will metastasize? What are the other possible side effects? Until you have some idea about the answers to these questions, then you cannot have informed consent.

Re:cancer worries

[BobMcD]

Sure you can.

"We cannot know all the risks, and you are proceeding under the condition that it is impossible to fully understand the impact of your choice."

We, by the way, make those kinds of choices every day. Nobody is psychic, and studies lie.

Besides, in a world where informed consent is impossible in these circumstances, how do you ever get any testing done? If those being experimented on cannot consent, is all testing no longer ethical?

Re:cancer worries

[Hellpop]

Its all good until someone gains an extra eyeball on their kneecap.

Re:cancer worries

[natehoy]

Weight is one of the smaller of her problems. In fact, her doctors aren't really worried too much about her weight.

She's got to exercise to strengthen her muscles (and heart, and lung capacity) to increase her chances of surviving surgery. But she's on heavy duty painkillers (occasionally up to and including morphine) just to be able to get out of bed to go to the bathroom.

Something like this, if it was really true, might allow her to start building cardio capacity without screaming in pain. I imagine she'd GLADLY accept the risk of cancer, because her prognosis at surgery is not good and getting worse.

Re:cancer worries

[randallman]

Wait awhile and magically the body heals itself.

Except that cartilage loss doesn't heal; at least not that significantly. My wife is a radiologist and I'm going to see what she thinks about the images this evening.

I hope this is for real. I've worn the cartilage in my knees over the years and while I don't regret the activities that caused the wear, it sure would be nice to get some more life out of the joints. All of the methods used now, like micro-fracture are just not very good.

Re:cancer worries

[natehoy]

I can't go that far. In this case, the FDA should at least be ensuring that the patients are informed that that their insurance companies now have valid cause to deny claims, and that the treatment is not proven to do any good, and that it might actually kill them, but that no one really knows for sure.

If, at that point, the patient wishes to proceed, I agree - the FDA can be heavyhanded on this sort of thing, and informed consent of the patient should trump FDA authority.

The patient should then be able to proceed.

Oh, one little detail. After canceling their insurance policy, signing a wavier saying that Medicare/Medicaid don't have to spend tax dollars to cover them. Once those little details are covered, they can proceed as they like.

Suicide isn't covered.

Re:cancer worries

[Chris Burke]

You know for sure this guy's malpractice insurance isn't going to cover it if his patients all end up with sudden cases of terminal cancer, and in the meantime his procedures on willing subjects are going to give the FDA tons of useful data.

Personally I'm not going to assume that a guy who is willing to ignore the FDA and start administering this treatment and advertise it with vacuous testimonials is going to make sure that he follows all the proper procedures to ensure that hs work constitutes a valid study that can be reviewed by the FDA and others.

There's a big difference between the way in which your personal doctor diagnoses and treats your ailments, and how this would be done within the context of medical research. Your doctor is making use of the results of medical research to do their best to make your life better, but your interaction with them does not constitute a valid way to recreate that research.

This guy seems to be operating in the mode of physician, not researcher. He seems to already be convinced that his treatment works and is safe, and not trying to falsifying either of those hypothesis as a researcher does.

Not in terms of the vacuous testimonials on this site, but in terms of "we don't know how big the risk really is yet, because we don't do this a lot in humans."

"Because we don't do this a lot in humans, and because what we are doing doesn't constitute a valid risk assessment study."

I really, really hope the procedure does turn out to be safe since I don't get the impression he's out to find out if it isn't.

Re:cancer worries

[Mister Whirly]

We all already have a slight risk of cancer without stem cells. Examining your family history may also help in determining if you are more susceptible to getting cancer.

I recall many people having the same opinion about laser eye surgery when it was new - that seems to have worked out quite nicely for the majority of folks. But it is all relative. If you are one of the small percent that has major problems, your perspective will be different.

Re:cancer worries

[Anonymous Coward]

I am a musculoskeletal radiologist.

On the pair of MRI images, which are probably proton density fat saturated images, the bone at the top of the pictures is the patella, shown here near the center where there is complete cartilage coverage, some of which is included in the circle. This cartilage is slightly irregular or frayed on the left, and smooth on the right. The bone near the bottom of the image is the femur, which is shown at a level above the cartilage. The dark signal material near the femur, more of which is included in the circle than patellar cartilage, is fat. Note that the patellar cartilage is different brightness than all of the fat (subcutaneous, or suprapatellar pouch) in these images.

In my opinion, there is no change between the two images. The knee didn't look severely damaged to begin with, and the area adjacent to the femur wasn't even cartilage.

Re:cancer worries

[Anonymous Coward]

A research group I worked for was tasked with analyzing the Vioxx data from the APPROVe study, which was the study that led to Vioxx being withdrawn from the market.

Fact: Vioxx did double the risk of MI, stroke, or CV death.

Fact: Vioxx improved arthritis with fewer GI issues than naproxen.

Fact: Vioxx reduces incidence of colon polyps. (APPROVe trial primary endpoint)

My point:

*All* drugs are risk/reward, including Vioxx. Drugs much the same as Vioxx remain on the market with warnings. Patients have told me they would 100% be willing to accept the doubling of the risk of CV event to have daily relief from arthritis.

Re:cancer worries

[Hadlock]

Cancer of the tendon isn't common, until you start injecting stuff like stem cells in there. Even if one in 10 million stem cells is cancerous, you've still got cancer in that region. If one in 20 million is cancerous, you've still got a 50/50 chance of getting cancer there immediately, and whos to say our stem cell techniques don't cause cancer 10 years down the road?

Re:cancer worries

[Chris Burke]

Now realize the cancer rate will NOT be zero, because the cancer rate of human flesh, natural or otherwise, is not zero. Therefore people whom get stem cell therapy will get cancer and die. Therefore, their Drs will get sued out existence. That will be the problem.

Unless they conduct an actual scientific study and determine that the cancer rate for those who received the treatment is the same as in the general population accounting for other risk factors, science yadda yadda.

At which point their Doctors won't be sued out of existence just like they aren't for anything else that could hypothetically cause cancer but, uh, doesn't.

So as far as I'm concerned the problem is "rebels" like this guy fighting the evil FDA who doesn't want to let him administer the treatment merely because there have been no human safety or efficacy trials.

I mean good for him if he helps people by not waiting for the studies to be done. On the other hand fuck him royal if he hurts people by not waiting for the study to be done. And when the first patient gets cancer after receiving treatment, and they sue him out of existence, hey, who's to say that isn't completely appropriate? The whole point is he doesn't know.

Re:cancer worries

[geekoid]

"slight slight chance of getting cander" *assuming you meant cancer

Except it's an unknown. Is it slight? NO one knows. And no, people are not a good source3 for making these kinds of desisions.
They don't understand risk, the don't understand statistics, and they are an easy mark for snake oil salesmen.

We have already seen immense damage from your line of logic with 'alternative' remedies.

Re:cancer worries

[geekoid]

Why do you assume cancer of the tendon? could cause cancer at any part in your body.

"That will be the problem."
No, it won't.

Re:cancer worries

[BJ_Covert_Action]

Well, he has this paper that he wrote: Safety and Complications Reporting on the Re-implantation of Culture-Expanded Mesenchymal Stem Cells using Autologous Platelet Lysate Technique

I don't know how credible that particular journal/magazine is as I am not familiar with it. But it is published openly.

Re:cancer worries

[geekoid]

All you have shown is that even with all the safety procedures, sometimes something may get through.
Of course, the actual risk of Vioxx is still debated.

Rofecoxib was tested. No the testing is perfect. Congratulation, you have shown that medicine is hard.

The risk of heart attack from Vioxx is no greater then ibprophen.

No one has shown any scientific evidence of anyone dying from it. Court awards were not around evidence, but around pity.
evidence

It's a problem of litigation. One that had prevented a helpful drug from being on the market.

Re:cancer worries

[Attila Dimedici]

But who do you trust more: the government (run by politics and bureaucracy and greed and greenbacks) or companies (run by greed and greenbacks)?

There fixed that for ya.
The answer is, I don't trust either one, but with companies I can usually figure out where their interests lie and determine whether their interests are in conflict with mine. With government, I find that much harder.

Re:cancer worries

[geekoid]

Haha, yes, dn't let your ignorance of the industry stop you from making stupid ass posts.

If this works, the insurance companies would embrace it. Hell, they embrace crap that doesn't work.
This treatment would be cheaper.

"Or is it the established medical community who are not tooled up yet for maximum profit on the procedure?"
That really makes you sound like a conspiracy nut. ..also it showcases you inability to think thoughts through.

It would mean that every company in the medical industry is working together in order to NOT make more money then the other guy.
Idiot.

Re:cancer worries

[geekoid]

They can do human studies; properly done their risk is LESS then using it as an unapproved treatment.

Why do you assume the risk is slight? Why do you even think this works?

I reread you post, and it's clear you don't understand risks and percentages.

Re:cancer worries

[geekoid]

And if you're bed ridden, it's even easier. Some ELSE is fixing your food. They can control your intake. Completely removes will power from the equation

Re:cancer worries

[geekoid]

1) Don't fast. Eat properly, understand your basic maintenance calories.
2) Discipline?
3) Proper eating training, education.

It's a known science. No magic.

And yes, supplements can help with a deficiency...that is why they are recommended to people who are deficient. However, you can get a proper diet that give a person the nutrients they need.

AS a side note, pretty much every healthy American gets all the vitamins and minerals through there normal diet.

Re:cancer worries

[geekoid]

How about the risk of spending her life sentence for something that has never been shown to work?

Re:cancer worries

[geekoid]

History shows that you are wrong.

You might want to study up on why there is an FDA, look into non-regulated countries, and realize that people are no damn good at making informed decisions about areas outside their expertise.

The only people who don't want the FDA are ignorant people, and people who want to bilk innocent people out of there life saving based on a promise. Which one are you?

Re:cancer worries

[martin-boundary]

No, it's a real ethical issue. When people are in pain, then they are willing to take more risks, but that's because they no longer think rationally.

If you let any two bit snake oil company offer them completely random treatments that don't actually work, then those people won't just be in pain, chances are that they will be dead and destitute as well as their family. That's a real economic cost to the country.

The only logical answer is to impose some standards on the treatments offered, and that eventually comes down to nationally forbidding some practices and not others, even if it takes a few years until proper testing has been performed.

Re:cancer worries

[butchersong]

I'm curious why on earth she would have had to wait 15 years to qualify for surgery. Was that for medical reasons?

Re:cancer worries

[jmorris42]

> ..there's a reason that the FDA takes a long time to approve treatments.

Yes there is, but you won't like it.

It is all in the incentives. If the FDA sits on a new procedure/drug/whatever another decade one of two things happen. One, they find a problem and everyone at the FDA is a hero. Two they don't find a problem and they approve the new treatment and the FDA is a hero anyway. Now consider the case where they see really promising initial results and fasttrack the treatment. If a decade later everything is good the FDA is a hero, but if anything goes wrong and they didn't put up every last roadblock to approval somebody at the FDA isn't a hero and probably gets sacked. Bottom line, the people who suffer and/or die during a prolonged approval process get no voice and thus can pose no harm to the career of an FDA official while victims of a mistake in approval get face time on TV and can cause much harm to a career.

Everyone is quick to get a pity party on for the hapless victims of a new drug that shows an unexpected side effect when it goes into general availability but until we ALSO pay equal attention to the ones who died waiting the year before a new treatment gets approved we will continue to misplace the balance point in the equation.

Re:cancer worries

[gangien]

The only people who don't want the FDA are ignorant people, and people who want to bilk innocent people out of there life saving based on a promise. Which one are you?

that generalization, is pretty ignorant, don't you think?

You might want to study up on why there is an FDA, look into non-regulated countries, and realize that people are no damn good at making informed decisions about areas outside their expertise.

well you're non regulated countries.. that could mean a lot of things.

I don't know a lot about cars, yet I bought a decent car.

I don't know how to make bread, yet i can buy bread.

I don't know how to make medicine, yet i can buy medicine.

I'm not an expert on almost any of the crap i buy. Yet most of the stuff I buy, is what i want, and of decent quality. Why? because of market forces. very little to do with regulations by government. Because guess what? people tend not to waste their money on crap that doesn't give them what they want for what they spent on it.

Re:cancer worries

[gangien]

if the FDA didn't exist, there would be people like consumer reports, underwriters laboratories, ect. that will fill that role. So you could still wait for whatever you want.

But who do you trust more: the government (run by politics and bureaucracy) or companies (run by greed and greenbacks)

the companies need to make a decent product, to get my money. That's pretty good motivation.

Re:cancer worries

[natehoy]

Well, there is certainly that risk. 50% chance with surgery, 75% chance (from an untrusted source) with this doc, unknown chance of complications. It's not an easy choice.

Re:cancer worries

[Cruciform]

If I had a painful injury that altered my quality of life, and I had the chance of healing it now with a higher risk of cancer in 10 years, I'd take that shot in a second.

I could have an aneurysm tomorrow, be hit by a car next weekend, or die of a completely unrelated cancer in a year.

Living should be about quality of life, not about hedging your bets that you're going to live to be XX years old.

Re:cancer worries

[Idiomatick]

I would be looking to the incedents of cancer in animals that have been having these treatments for many years to give an estimate of cancer rates.

I think I'd approve it for use for the elderly. Cancer is less of an issue if you only get light cancer for a few years before you die. Cancer isn't like a cold, you dont generally get it suddenly, you might get it 10years later (with your chance of getting it increasing each year). And currently the other option is surgery; For the elderly surgery could be worse than cancer. Or they could be inneligible for any option. So for at least one group there are minor downsides, huge upsides. That should be enough to get it pushed forward.

Re:cancer worries

[BigSlowTarget]

Green? Injected into people? Material could go beserk and cause rapid growth of tumors? The company is testing quietly to avoid government intervention? Now we know Racoon City is actually in Colorado. Watch out, you all know what happens next.

Re:cancer worries

[Wolfier]

A 90 years old wants to walk again after years of immobility probably wouldn't care any cancer that may or even WILL come up 10 years down the road. However, a 25 years old probably has a different opinion.

This is the problem. FDA either approves or disapproves a treatment for everyone, it doesn't say, "if you think you have maybe 10 years to live anyway this should be okay".

Re:cancer worries

[kcelery]

I know you're gonna say it : "if they don't have back pain, we'll give them one".

Re:cancer worries

[hackingbear]

Don't you think they have thought about that and put it in the release forms? In this country, no doctor will give you any big treatment without collecting release forms. I signed plenty.

Re:cancer worries

[Pigeon451]

One cancer cell doesn't necessarily develop into a tumor. Generally the body is capable of disposing of rogue cells regularly, but it depends on many factors.

Re:cancer worries

[Aphoxema]

It's not just about losing weight... Hell, it's not about losing weight at all! How much and what you eat is irrelevant compared to the necessity of regular activity on your health. The number on your scale Does Not Fucking Matter. What exercise is important for is virtually every function of every system of the body. Be careful when you help to inform people otherwise; you might be helping to give them an early heart attack with misinformation. You don't have to be an Olympic athlete or even once experience getting high on exertion, just a 20 minute walk every day would massively benefit people who've gotten too comfortable with their computers and could help them avoid diabetes, cardiac muscle damage or loss of kidney function. Even things we take for granted, like pooping or sitting can be made far more comfortable by improving digestion and building new blood capillaries.

Re:cancer worries

[repapetilto]

Bone has living cells in it that secrete hydroxyapatite crystals and connective tissue (forming the hard bone part) as well as a bunch of relatively rapidly dividing cells that replenish many of your blood cells. All the blood vessels needed to support these cells are there too. While UV radiation may not have much effect on bone mutation rate, there are many chemicals generated naturally in the body as a natural part of cellular metabolism (oxidants like H2O2, superoxide, peroxynitrate) that can also cause DNA damage and thus mutations. Also since there is a blood supply, any mutagenic chemicals that get into your blood stream can also access your bone (some chemo drugs even actually preferentially collect there if I remember right). Cancers do often develop from the cells of the bone, especially the rapidly dividing ones. Leukemia is an example of this.

Also the treatment involves removing the precursor cells to your bone creating cells and stimulating their rate of division in a flask to above normal levels. When in the flask the cells are possibly more exposed to environmental carcinogens like UV light or chemicals during the time when DNA is most vulnerable (while being replicated), plus they may have undergone physical damage during the removal, culturing, and reinjection processes leading to cellular stress and excess oxidant production. They have also been removed from an environment in which immune cells are constantly surveying looking for mutant cells to kill, so any mutants that do arise are more free to multiply.

As a result it should be expected that stem cell therapy, even using bone stem cells, carries with it an increased risk of cancer. These people say they've shown that's not what is happening, ultimately fact trumps theory so it comes down to how strong the proof is that someone provides and how much you trust them. They've only waited 2 years and it can take awhile for a cancerous cell to divide enough times so that a tumor is detectable, I'm not sure how long this would be for the types of cells theyre growing or how many cells were used or anything so I'm not sure if that should be long enough to judge or not.

Re:cancer worries

[Matrix14]

Then it's AWESOME.

Re:cancer worries

[RMH101]

Market forces don't care about long term safety. See melanin in baby milk, Chinese Heparin production, etc.

Re:cancer worries

[gangien]

yes they do. see all the companies making profits off of organic food and such(even though i think that's bullshit), see people investing for retirement. I think it's a little weird you would try to cite an example from china.

Not surprising

[MBCook]

I don't remember anyone saying stem cells were bad, it's always embryonic stem cell that caused controversy.

This doesn't surprise me. I always figured some other country would start doing this, get amazing results, and then the laws would change fast once it stopped being claims of future magic and became real, testable results. When you start getting these kind of great results, the moral argument gets harder.

Re:Not surprising

[Bill, Shooter of Bul]

Uhm, these results are being achieved with adult stem cells. Non controversial to anyone. No need for any laws to be changed, they extract stems cells from a person, and inject them back in the place needed.

Re:Not surprising

[fusiongyro]

Results don't have anything to do with the moral argument. Proof that eating babies gives you laser vision would not lead to legalization of baby eating.

Furthermore, embryonic stem cell research was never actually banned. The federal government just wasn't willing to pay for embryonic stem cell research, which seems like a fair response to morally questionable research. At any rate, my understanding is that adult stem cells have produced more and better results anyway, and that's exactly what this doctor is doing: taking your own stem cells and giving them back to you. No fetuses = no moral problem. What's actually being skirted here is federal regulation over medical and drug procedures, not anything specific to stem cells.

I personally think people should be permitted access to experimental medical procedures, as long as they understand that as they are experimental, they're waiving their right to sue for wrongful death or medical malpractice, as well as any federal mandate for it to be covered by their insurance. If you have money and want to take the risk, by all means have at it. As for me, the state can pay for it when I'm reasonably convinced of the scientific validity—which includes that the long-term side effects do not outweigh the short-term benefits.

Re:Not surprising

[timeOday]

I think we're supposed to assume that the FDA hasn't approved these techniques due to ethical concerns, and get all worked up about fundamentalist Christianity hampering scientific progress.

Of course the truth is the FDA hasn't approved it because nobody knows whether it really works and what the side effects might be. I suppose it's possible the Singularity Hub found the fountain of youth, and it's as simple as just shooting up with stem cells, but somehow I doubt it.

Re:Not surprising

[MBCook]

I'm aware of all that, and I still think that fetal stem cells shouldn't be used. But I think many politicians who were willing to stand up and say "we shouldn't do this, think of the children" would back down if amazing results started coming in. I just don't think most believe those positions strongly enough to keep up the fight.

This is an interesting development, but I expect they'll be shut down. Either way, the big question is do the people end up tumor-ravaged 5 years later. Even if everyone agreed this was as legal as drinking water, it couldn't become a normal treatment for years due to testing.

Re:Not surprising

[MBCook]

I know, I like to inject that word (embryonic) into these conversations. Some groups really love to go around with that "they hate saving people with stem cells" argument, leaving out that crucial word; completely changing the meaning of the statement.

I was aware embryonic cells weren't used here, but re-reading my post I see that wasn't clear.

Re:Not surprising

[maxume]

How do the moral arguments change with the efficacy of the treatments?

Are there really people who believe the lump of cells has a soul, but it is okay to destroy it to fix cancer in papa?

Re:Not surprising

[WrongMonkey]

If you allowed patients unrestricted access to experimental procedures, you're removing any incentive for companies to spend the time and money to thoroughly test anything. People will still pay, because their desperate for any sliver of hope and the pharma industry would be automatically protected from lawsuits.

Re:Not surprising

[natehoy]

It's not embryonic stem cell issues at work here, it's the unknown effect of taking stem cells from the marrow, concentrating them, and re-injecting them into the patient. Stem cells might grow into the material you want, or they might go all cancerous. Testing it is hard because people die if it goes badly, and without testing the FDA isn't about to put a seal of approval on it.

So, on one hand this guy's a maverick boldly testing out a new procedure and helping his patients in the short term, and doing clinical trials on real patients to determine the risk levels. On the other, he's putting each and every one of them at an unknown level of risk of dying of a virulent strain of cancer.

Only history will tell if he was a heroic maverick, bucking the system and getting good medicine done a' la hundreds of bad American cop movies (and we'll all point and laugh at the slow stupid FDA for not making a faster decision and wasting our tax dollars delaying real help to real people), or a reckless asshole who ended up killing a bunch of patients with particularly virulent strains of cancer and, by doing so without FDA approval, managed to screw up their medical coverage of that condition so they ended up dying in pain and broke (and we'll all point at the FDA for not stopping this nefarious villain like they were supposed to and wasting our tax dollars allowing real people to be killed by dangerous experiments).

Re:Not surprising

[maxume]

It removes one 'incentive' for testing (the government requiring testing is really more of a requirement than an incentive). It doesn't remove incentives like certification by an independent body (say, the AMA or whatever, maybe they aren't independent enough).

(The notion being that the certified treatments would be more reliable, and thus easier to sell)

Re:Not surprising

[yog]

Fusiongyro,
ESC research funding was cut off completely and entirely. No lab that accepted federal funding could do ESC, and they couldn't even use existing equipment for privately funded ESC if that equipment had been paid for in any way by federal funds. Effectively, the research was banned in every sense but the literal one.

Relevant to the article, which is a poorly written promotional piece of fluff, this clinic that is offering stem cell therapy should warn its patients that there is strong evidence of cancer resulting from stem cell injections. This is one of the main reasons stem cell therapy has not made it into mainstream medicine (it is being used in Brazil with some success).

Religious fundamentalism aside, there's a reason for caution in the approval of new treatments such as stem cell therapy. For example, tysabri is a promising new drug for treating multiple sclerosis, but after several human deaths it was discovered that it activates a normally dormant virus in the brain in a few people, killing them. It was taken off the market, then allowed back under stricter controls. Thalidomide was handed out all over the world in the 1950s, resulting in horrible birth defects. Fortunately, the FDA blocked its approval in the U.S., probably saving thousands of children from disfigurement.

I'm all for stem cell research, and I think the Bush Administration and the fundies were idiotic for blocking it, but we can't just approve every new treatment that comes along without some rigorous testing. On the other hand, if patients are adequately informed of the risks, and I'm not the one paying for the side effects they may encounter, more power to them.

Re:Not surprising

[badboy_tw2002]

No, its just that their convictions weren't that solid to begin with. Its easy to say "I'm against that, and I'm hopping mad about it" when its something abstract that doesn't really affect you. Its a much bigger deal when its "You're Dad has cancer. We can cure him but we'd need to destroy these cells we were going to leave sitting in a freezer for later disposal." There are a lot of people who would stand by their convictions to the bitter end (true believers) and theres' a lot of sheep who will break at the first sign of being personally affected by their belief system.

Re:Not surprising

[Hatta]

Furthermore, embryonic stem cell research was never actually banned. The federal government just wasn't willing to pay for embryonic stem cell research, which seems like a fair response to morally questionable research

When you look at how research is funded, withholding federal funds might as well be a ban. Meanwhile all those stem cells end up in an incinerator instead of potentially yielding knowledge. That's not morally questionable, that's flat out wrong.

Re:Not surprising

[fredjh]

People will still pay, because their desperate for any sliver of hope and the pharma industry would be automatically protected from lawsuits.

So, your answer is to create a decades long bureaucratic process that removes all hope whatsoever.

I don't think I like that alternative. Oh, I know I just presented a false dichotomy and that's probably not what you meant, ideally things can move along faster than that, but in practical terms they don't.

So we have the ongoing cases right now of people wanting to take experimental drugs for their cancer... the government won't let them. On the one hand, they may die if they take these experimental drugs; on the other, they most assuredly will if they don't. Shouldn't it be their choice?

Full disclaimers, of course... patients need to know the drugs or procedures are not vetted by the FDA, that's fine, it's the government telling me I CAN'T do something that bothers me... if they want to warn me before letting me make my own decision, that's fine with me.

Re:Not surprising

[LanMan04]

I still think that fetal stem cells shouldn't be used.

They don't do anyone any good sitting in a biohazard disposal bag. What the issue? Fetus is already dead.

Re:Not surprising

[vlm]

managed to screw up their medical coverage of that condition so they ended up dying in pain and broke

Wait a second, at first you said this dude was a doctor, but then you give the job description of an insurance company, especially the last bit of my quote.

Or, if we accept that everyone eventually ends up like that, regardless of this doctors actions, then what exactly is the downside of what this dude is doing? That they died in a great adventure? That they didn't die for nothing? That both the dr and the patients had more guts than the average pile of quivering flesh and we're all supposed to be conforming cowards, thus they're bad examples for us?

Re:Not surprising

[rattaroaz]

Results don't have anything to do with the moral argument. Proof that eating babies gives you laser vision would not lead to legalization of baby eating.

This is a straw man argument though. Not really talking to you, but rather, others who make this argument against fetal stem cells. The stem cells from fetuses are from already dead, aborted fetuses. No one, that I know of, is advocating killing fetuses for the sake of getting the stem cells. But since they are already dead, why not harvest them instead of throwing them in the trash? Kind of like harvesting organs from a dead guy, only aborted fetuses usually do not have funerals or viewings. I think the bigger question is "is abortion moral?" Talking about taking the stem cells seems to be just dancing around the topic. If abortion is immoral, then certainly taking the cells is too. If abortion is not immoral, then not sure why throwing the fetuses in the trash is an more moral than experimenting with them.

Re:Not surprising

[ArcherB]

This doesn't surprise me. I always figured some other country would start doing this, get amazing results, and then the laws would change fast once it stopped being claims of future magic and became real, testable results. When you start getting these kind of great results, the moral argument gets harder.

Remember that the "moral argument" against stem cells only deals with stem cells derived from by starting an embryo and destroying it. Embryonic stem cells from existing stem cell lines, embryonic stem cells derived from other methods such as cord blood, and adult derived stem cells have not "moral argument" against them.

Since the results discussed here are from adult stem cells, it actually supports the "moral argument" and makes the argument for embryonic stem cells that much harder. Even the "Father of Stem Cell Research", James Thomson now believes that there is no point in pursuing treatments from embryonic stem cells because of the risks involved and the superiority of adult derived cells from the actual patient.

Re:Not surprising

[Tenek]

No, we don't need history to tell. If it turns out to be a miracle cure then he'll have been lucky, but no less a reckless asshole. If you want to practice 'good medicine' you establish that it works safely before you start using it on everyone.

Re:Not surprising

[cdrguru]

The problem with embryonic stem cells is that for any treatment to really exist, the cells would have to be a genotype match with the person being treated. This brings into focus a small, tiny, little problem - if you can make embryonic stem cells to order that match a specific genotype, you have just solved the problem of human cloning.

Now you have a real choice indeed - do we treat the heart condition with stem cells, or do we simply replace the heart with a newly grown one? I suppose an argument could be made that as the cells more or less came from the person being treated the clone (that grew the heart) doesn't really have any right to exist apart from the original. I don't think I would like to review the court transcript that would be involved with this decision, as it might be really, really thick.

How about demonstrators chanting "Freedom for Clones!" This and many other things follow from embryonic stem cells. I don't really care when you kill off the bunch of cells - once you have the ability to on-demand make genotype specific cells, you have human cloning. If this provides meaningful treatments, there will be no stopping it - there will be cloning. And we better figure out how exactly to deal with that little problem. Burying your head in sand isn't a solution.

The Bush solution was simple - just say no for a variety of reasons without getting into the specifics. Obama may (or may not) understand the real ramifications of success here, but by repealing the ban we are clearly opening the door to a discovery that leads to human cloning. And it will be pretty much unsupressable once it is discovered.

Want Bill Gates to live forever through clones? How about Warren Buffet? John McCain is probably got enough money to go for it, if a solution gets found soon enough. So, no, it isn't just about killing babies. It is about human cloning and all that goes with it. Personally, I think the risks outweigh any possible benefits because the risks are so incredibly large.

Re:Not surprising

[ArcherB]

I know, I like to inject that word (embryonic) into these conversations. Some groups really love to go around with that "they hate saving people with stem cells" argument, leaving out that crucial word; completely changing the meaning of the statement.

I was aware embryonic cells weren't used here, but re-reading my post I see that wasn't clear.

That's the argument that kills me. I've heard people that should know better claim that Bush made stem cell research illegal. For example, on Dr. Dean Edell's radio show, he rails against Bush and the Church for halting stem cell research when he should know that it's simply not true. Bush made a compromise. He didn't outlaw stem cell research. He didn't ban federal funding for stem cell research. He authorized for the first time stem cell research limited it to existing stem cell lines only. No federal funds would go toward research involving new embryonic stem cell lines. People like Edell got pissed, even though there was no federal funding before this like a spoiled 16 yr-old girl who is mad that her new Ferrari is the wrong color.

Re:Not surprising

[Daxx22]

No, but stem cells to the the average joe have achieved a similar status as nuclear power. AKA while there is are perfectly safe(nuclear) and morally fine (stem cells) way, they both suffer from their earlier associates. After all, ask yourself whats the first thing that comes to mind when you say stem cells? Usually it's the embryo controversy.

Re:Not surprising

[badboy_tw2002]

Whats the problem with cloning exactly? So Bill Gates wants a child with most of the same genes he has, who cares? Its not him. It might not even look a whole lot like him due to other factors we can't control. And growing body parts does not equal cloning anyways. If you grow a heart, its just an organ ready to be transplanted, not a whole person. A clone would still have to be embedded in a woman and birthed as normal. It would have all the same rights as any other person.

Re:Not surprising

[BlueParrot]

Only history will tell if he was a heroic maverick, bucking the system and getting good medicine done a' la hundreds of bad American cop movies (and we'll all point and laugh at the slow stupid FDA for not making a faster decision and wasting our tax dollars delaying real help to real people)

Nonsense. The outcome of a gamble does not affect the information upon which the decision was made. If he happens to get lucky that does not mean he did not act irresponsibly, and conversely if the treatments end up going bad it does not mean it wasn't worth a shot. Whether his actions are responsible or not is a matter of the evidence at hand when he decided to try it, and I doubt anybody here is qualified to comment on that.

It's a bit similar to a trial. If you execute somebody without any evidence of their guilt, then even if it is latter found out the guy did in fact murder a lot of people it does not mean the judgment was just, because it was little but sheer luck that the accused was in fact guilty. The same applies in this case. He may be acting responsibly or not ( I'm not able to tell ), but which it is does not depend on the result of his experiment.

Re:Not surprising

[Beezlebub33]

But, that's silly because we are going to figure out human cloning. Eventually, if it can be done (and I don't know of any show stoppers), someone will figure it out, regardless of whether we used embryonic stem cells or adult stem cells. So, the moral questions about human cloning are relevant, regardless of the moral questions about ESCs, which appear to be highly entwined with moral questions about abortion.

So, we're going to be able to make human clones, we're going to be able to make organs, and might as well start figuring out how to deal with it. Putting your finger in the dike isn't going to work on this issue. As usual, the people who have been thinking about this sort of thing are the sci-fi writers. Maybe we can have William Gibson or Bruce Sterling help us work through the implications. Actually, it would be nice to have a clone of Asimov that we can have ponder the issues, but maybe he'd be biased.

Re:Not surprising

[drunkenoafoffofb3ta]

I don't really think people should have "moral problems" with embryonic stem cell research. Human embryos left over from IVF are (mandated by law) thrown in a bin. Is IVF immoral?

Embryonic stem cells have many, many reasons going for them over adult stem cells, not least of which a lower potential for developing into cancer. In terms of basic medical research, they are - for want of a better phrase - a godsend. Adult stem cells are not as good.

Why should "moral issues" about trash from a process that brings the joy of children to many stop genuine medical advances?

Anyhow, clinical trial entry in the US is dependent on the person receiving the trial therapy signing a waiver saying that they understand what they're doing. The worrying thing in this circumstance is that these people are desperate, which never helps clear judgement.

Re:Not surprising

[natehoy]

No, what I'm saying is that, if you engage in treatments that are not FDA approved and your insurance company finds out about it, they can screw with your coverage.

The FDA exists to approve substances as "reasonably safe". If you take something that is not found to be "reasonably safe" and you die of it, your insurance company could very feasibly deny claims.

Re:Not surprising

[natehoy]

Sorry, that was an attempt at sarcasm.

In reality, he's a reckless asshole. But, for his patients' sake, I hope he's right.

Re:Not surprising

[DaFallus]

Proof that eating babies gives you laser vision would not lead to legalization of baby eating.

Then only criminals will have laser vision! Think of the children! The tasty tasty children...

Re:Not surprising

[shutdown -p now]

Unused embryos aren't "killed children". And we have already set certain implications by allowing in vitro fertilization that routinely produces and then discards those embryos; so long as it is not morally objectionable, neither is using the cells harvested from such embryos.

Re:Not surprising

[MojoRilla]

Bush's decision on stem cells might have been a good compromise at the time, but it was one that ignored further science. Read this analysis from slate.com. There were supposed to be 78 stem cell lines available after Bush's decision, but by 2005 there were only 22 that were available, and some of those had degraded to the point they weren't viable. The science was clear that the existing cell lines weren't enough, and even Bush's own NIH Director disagreed with the policy by 2007.

Re:Not surprising

[geekoid]

'moral questionable' is cultists way of saying 'we don't like it, so no one should get it'.

" adult stem cells have produced more and better results anyway,"
false. However they may, eventually. sadly if they could get federal funding for embryonic stem cells(cells that were going to be thrown away anyways) we would be a decade farther along, and probably wouldn't need them anymore.

It got stopped by a bunch of lies from the hypocritical neo-cons.

Re:Not surprising

[Ironhandx]

Yay for Troll 2.0

Accuse someone else of trolling while actually trolling yourself.

You can do better, really. I hear some people have upgraded to Troll 4.0 already!

Then again, maybe /you/ can't do better.

Re:Not surprising

[coredog64]

Actually, by the time you get to the age where a fetus can be detected and aborted, it's too late to grab stem cells. The source was left over fertilized eggs. Now, today we might be able to get all the ESC we need from this source, but there's a bigger moral question: Do you allow the creation of fertilized eggs solely so that you can harvest them for ESC? And what happens if/when a viable treatment that requires ESC comes on the scene? At that point, demand would certainly outstrip the current supply.

Re:Not surprising

[THENate]

Federal funding was ended for new embryonic cell lines. Research involving existing lines was not banned or restricted at all.

You were correct about the separation of research, of course, but recall that private funding spiked. Less funds total than if the federal government funded it? Probably. Effective ban? No.

That's certainly not a complete ban, without a stretch of imagination applied.

Re:Not surprising

[TrisexualPuppy]

And we have already set certain implications by allowing in vitro fertilization that routinely produces and then discards those embryos

The notion that YOU have set some precedent does not imply that an action is moral or ethical.

Re:Not surprising

[dissy]

You'd rather the stem cells end up in an incinerator instead of a lab?

Yes.

In an incinerator, the value of those stem cells becomes zero.
This means we are not increasing the value of stealing babies to harvest for stem cells on the black market.
This is a good thing.

There are other ways to obtain stem cells that do not involve the unborn and very recently born.
(Some even say those other ways work better)

Re:Not surprising

[Spykk]

Results don't have anything to do with the moral argument. Proof that eating babies gives you laser vision would not lead to legalization of baby eating.

If you don't legalize baby eating, then only the criminals will have laser eyes.

Re:Not surprising

[dissy]

The stem cells from fetuses are from already dead, aborted fetuses. No one, that I know of, is advocating killing fetuses for the sake of getting the stem cells.

The only problem is, that is Exactly what you are advocating in a capitalist nation by placing a value on something.

Granted, I doubt that was ever the governments intent there, but it is still a concern. The government can only outlaw the practice (well, more so than it already is) but as we all know that doesn't always stop a thing from happening, it can only punish those who did after the fact.

 

Re:Not surprising

[bit01]

Shouldn't it be their choice?

It's difficult for them to make an objective choice, if for no other reason than the drug company is the only source of information about a drug early in a drug's life cycle. For obvious reasons drug companies are notorious for overselling their products and that "choice" you talk about is pointless if objective information to base it on is not available. In addition one of the biggest problems with the current system is that the drugs are tested by the drug companies themselves, not an objective third party. With the best will in the world they're still biased. No easy solution.

It's not either-or of course. It should be possible to create an intermediate level of auditing that gets experimental drugs out reasonably quickly giving new patients some level of objective safety and assurance of efficacy.

---

Windows and closed source software. The US intelligence agencies back door to every network connected country and business on earth.

Re:Not surprising

[shutdown -p now]

My point was that this is no more "down the slippery slope" than we already are. If you believe that what we are doing today is fine, then using stem cells is fine, too. If you think that what we're doing is wrong, then this is the "same kind of" wrong.

Re:Not surprising

[rattaroaz]

The only problem is, that is Exactly what you are advocating in a capitalist nation by placing a value on something.

I don't think my point was clear. I haven't heard anyone preaching "get your abortions here for the sake of stem cells." Nor have I hear anyone say "I'm getting an abortion so I can give the tissue to science."

If someone gets knocked up and wants an abortion, more likely than not, they will want an abortion for personal reasons, not so they can donate the tissue. But one man's trash is another man's treasure. Since they are throwing the fetus away, why not harvest the organs? I'm pretty sure these stem cells are still good, despite another post. Maybe not same quality as embryonic stem cells, but still usable.

Re:Not surprising

[repapetilto]

What makes you think embryonic stem cells are less likely to develop into cancer?

Re:Not surprising

[argStyopa]

"I think the bigger question is "is abortion moral?" " ...and I think you're absolutely right.

I think the Bush administration felt this was one small issue that they could 'take the risk on' and make a moral stand against something-somewhat-in-relation-to abortion, and perhaps it would be a camel's nose situation.

People seem to instinctively understand this, and the split over embryonic stem cells mirrors perfectly (in all the folks I've talked to) the split on abortion.

Personally I have deep qualms about abortion, and I also had deep qualms about the use of embryonic stem cells.

Re:Not surprising

[argStyopa]

"Proof that eating babies gives you laser vision would not lead to legalization of baby eating."

That's a rather sweeping, unqualified statement.

Let's think of all the morally objectionable things that humans have done over the centuries. Logically, the people that did them, did them for some reason more tangible than simply 'motivated by evil', no? One might posit that with enough reward, people can be induced to do almost any abhorrent thing.

Thus I think it's a far more reasonable and historically supportable conclusion to say that if you had incontrovertible proof that performing an abhorrent act would give you some irrefutable personal gain, SOME people would, indeed, try to perform that act.

Re:Not surprising

[fredjh]

Of course it's hard to make an objective choice when you're given a "death sentence" by your doctor, but at that point does it really matter?

Slashdot Shopping Network

[oldhack]

"Now, in an exciting development, Regenerative Sciences Inc. in Colorado has found a way to skirt the FDA and provide these same stem cell treatments to humans."

And if you call in the next 15 minutes, you get 5 plastic syringes, absolutely free.

Call now.

* The free syringes may or may not be new pending supply.

Re:No Surgery Required?

[natehoy]

Just in case you were asking a serious question, and not looking to insert a South Park reference...

These are autologous stem cells (meaning YOUR OWN). No harvesting from anyone other than you.

They harvest a small amount of your own bone marrow, extract the stem cells from it, and inject them into the spots where they are needed.

Having said all that, this is a really glowing report that claims to be taking a harsh look at the company, then uses testimonials and reference materials from their own web site to "prove" it. It may be legit, but I smell just the faintest tang of green-colored artificial grass product.

alternative treatment

[losfromla]

I am all for this therapy, but the hard numbers they talk about say things like "%x patients feel %y better..." I know that it will receive a standing ovation in slashdot but, these are not hard results, they are anecdotal. I'd like to see x-ray or cat scan evidence of, say % regeneration after x months, etc. If the topic were alternative eating regiments or differences from eating organic vs non-organic (spare the rants, we know that words mean different things in different contexts and we're not talking o-chem), or improvement from chiropractic care, then I'm sure no one here would accept their "hard numbers" easily.

Re:alternative treatment

[TubeSteak]

I am all for this therapy, but the hard numbers they talk about say things like "%x patients feel %y better..." I know that it will receive a standing ovation in slashdot but, these are not hard results, they are anecdotal. I'd like to see ...

RTFA noob. They've published a paper detailing the outcomes of 227 patients.
Abstract and the Article (PDF)

"Serial MRI's at 3 months, 6 months, 1 year and 2 years failed to demonstrate any tumor formation at the re-implant sites."

Re:alternative treatment

[losfromla]

RTFA? On slashdot? And you call me a noob? All the same, I did so earlier. Lack of tumor formation does not address improvement, it merely covers lack of harm being introduced. Go swallow your favorite snack/name, you wannabe elitist with utter lack of reading comprehension.

Re:alternative treatment

[MightyMartian]

When someone else can replicate the results, then you can say "They've done something!!!" Until then, this looks too good to be true (and certainly flies in the face of experience with stem cells thus far), so probably is.

Re:alternative treatment

[sjames]

They're using figures similar to those used for surgical procedures including replacement. It's necessary to use those procedures for replacement since all an MRI can say there is yes, there is an artificial implant there. For this, they're trying to avoid apples to oranges comparisons.

The problem with % regeneration over x months is that we don't CARE about the volume of the tissue so much as what that does for the patient. We care about how much less pain the patient feels during daily activities and whether or not the patient is able to return to activities they had to give up before due to their condition.

Re:alternative treatment

[natehoy]

Great, except of course cancer doesn't always play nice and develop immediately, or even within a couple of years. Plus, he's injected millions of stem cells per patient. Cancer may not develop immediately around the injection site, the cells might migrate somewhere else before a few of them mutate.

This is something that the FDA has been trying to get long-term controlled studies on. Eventually, this guy's new "study" will be one of them, no doubt, but I certainly hope that the worst that comes of this is that the FDA looks like they were slow and dim-witted waiting for data before making a decision.

Because the alternative is ugly. Unlikely, true, but ugly.

Re:How great

[Red Flayer]

Finally. One daring little company, and we finally move forward. Thumbs up for the Colorado mavericks.

Hah. Shutdown pending in 3... 2... 1...

The clinic that is using this treatment is claiming that the FDA does not apply to them, because they the treatment is within their clinic and has nothing to do with business outside of Colorado.

Good luck with that claim.

For example, is the clinic aware that the State of Colorado requires medical practitioners to comply with federal regulations in order to maintain their license? Please see this document for the legal requirement (PDF; specific location of federal compliance language begins on page 60 of the legal document, which is page 63 of the pdf).

That "one daring little company" is gonna get shut down, which is a good thing. Clinical testing of their treatment method has yet to be completed, and a lot of people could get hurt if it turns out there are problems.

Ends & Means

[hardwarejunkie9]

Do not rule out the importance of ethics in science. They guide us in possible repercussions of our actions. The interesting point is that there are more kinds of stem cells than just embryonic. To argue that embryonic cells are the only way is to ignore equally viable options. Simply to say that embryos aren't people is to apply the same logic used to pardon the continuation of slavery. I say that if there's a way to get scientific results while avoiding ethical concerns, then that should be our main focus.

Re:Ends & Means

[Lunix Nutcase]

Simply to say that embryos aren't people is to apply the same logic used to pardon the continuation of slavery.

Except that under the law one has to actually be born to become a citizen and gain the rights of citizenship. So no, they aren't "people" in the legal sense. Also, your argument is just the same slippery slope nonsense as the people who argue that the decriminalizing of consensual homosexual sex is going to lead to widespread beastiality and pedophilia.

Re:Ends & Means

[MrMista_B]

The result of not acting is that people are unnecessarily suffering and dying. You think that's a good thing? You think that's even something that can be called ethical?

Re:Ends & Means

[eabrek]

Please see Dred Scott. Legal != Moral

Re:Ends & Means

[TooMuchToDo]

Simply to say that embryos aren't people is to apply the same logic used to pardon the continuation of slavery.

Please do not compare a mass of cells to a human being. They are not the same thing.

Re:Ends & Means

[eabrek]

The slavery analogy is referring to the law. The current law is that some human beings can be killed, while shifting those same people 1m in any direction suddenly gives them full rights.

Sex cells are not people. They have only 23 chromosomes, and all of those are taken from the parent/host. Embryos have ~46, and do not match either parent.

Re:Ends & Means

[vlm]

Except that under the law one has to actually be born to become a citizen and gain the rights of citizenship.

You sure about that dude, "born" like corporations? Don't forget, corporations are citizens too, in fact superior to us second class human being "consumers" since they are above most criminal law, cannot be imprisoned, etc. I can think of several corporations that need aborting, if you'd like to collect their "stem cells". SCO, GM, Goldman Sachs, etc etc etc.

Re:Ends & Means

[vlm]

Please do not compare a mass of cells to a human being. They are not the same thing.

Not fair to only look at the start of life. How bout the end? That brings up all kinds of fun arguments about vegetative states, and the exact date and time you can euthanize an Alzheimer patient.

But the main problem is, your argument is nothing more than "TooMuchToDo" says so. If you got too much to do, slow down a bit and take the time to enlighten us, not just preach.

Re:Ends & Means

[IICV]

Using embryonic stem cells is not at all ethically questionable. They come from the left-over embryos from IVF treatments that would otherwise be thrown away or stored until someone else is willing to try using them.

When it becomes questionable is when these embryos are generated specifically for their stem cells. This is not, however, something that will happen in the foreseeable future.

IVF protocol involves creating multiple embryos, and attempting to implant them a few at a time. Because there's little marginal cost in generating many embryos over generating one embryo (while you're extracting eggs, you might as well get as many as you can), there are almost always leftovers which the genetic parents do not need. These are either disposed of or stored for people who cannot generate embryos.

There are something like 700,000 IVF treatments a year. That's enough to both supply people who cannot create their own embryos as well as any researchers, and if the scientists don't discover anything worthwhile with embryonic stem cells it won't be an issue - and if they do find some treatments that are worth the effort, then we can discuss the ethical implications.

Re:Ends & Means

[TooMuchToDo]

But the main problem is, your argument is nothing more than "TooMuchToDo" says so. If you got too much to do, slow down a bit and take the time to enlighten us, not just preach.

Actually, my argument is based on what is written into US Federal Law. Now, you may be able to make some sort of vague argument that "life", or rather consciousness begins at some point before birth. And I'd agree with you. But until you can scientifically observe the moment consciousness and self-awareness begin/occur in an embryo, I believe for most purposes (abortion, medical research, law) birth is going to be considered when you become a person. This of course doesn't take into the states where they have coded in law that a fetus is a person. http://www.ncsl.org/IssuesResearch/Health/FetalHomicideLaws/tabid/14386/Default.aspx

Re:Ends & Means

[tthomas48]

I am impressed by the strong scientific backing for your completely arbitrary belief system. I personally couldn't call two fertilized cells that had failed to adhere to the uterine lining a person. But perhaps that's because I don't enjoy viewing sex as genocide.

Re:Ends & Means

[eabrek]

I'm not sure I understand your point.

Science is not arbitrary. A fertilized embryo (one cell, where there were two gametes) is a new "person" for any measurable use of the term (avoiding arguments over "personhood" or "sentience").

Failure to implant is a death sentence. But being under a death sentence doesn't make you not a person.

Re:Ends & Means

[eabrek]

Some argue self-awareness does not begin until age 1 or 2. There is no mental difference between a child at 9 months in the womb and out (not to mention, children born extremely prematurely often survive).

Our current laws are illogical, and should be overturned.

Re:Ends & Means

[alan_dershowitz]

Slaves weren't citizens either. Also, you become a natural born citizen at birth, it doesn't say "person" at birth under the law.

Re:Ends & Means

[Lunix Nutcase]

Of course, but his claim is just a fallacious slippery slope argument.

Re:Ends & Means

[Lunix Nutcase]

The point of my statement was one that his claim that using embryos for stem cells leads to the notion that slavery is okay is fucking stupid. It's the same nonsense that the same right-wing fucktards say when they try to claim that decriminalizing consensual homosexual sex was supposed to lead to this widespread beastiality and the legalizing of pedophilia. They're both fallacious arguments with no basis in reality.

Re:Ends & Means

[tthomas48]

Listen if we're talking about the lack of arbitrariness in science, then a human being definitely does not become a human being until they're born and take their first breath. That's the most absolute measurable standard.

If you want to debate at what phase it is ethical to abort a human embryo, we can do that. But let's not confuse what a "person" is. Ethics and science are different, and just because we arrive at an ethical conclusion does not mean that it changes the scientific one.

The wikipedia entry you're looking for is "Developmental Biology"

Re:Ends & Means

[eabrek]

What is on the slope here? We're saying it is unethical to kill embryos for research purposes.

Re:Ends & Means

[eabrek]

What?

Are you seriously suggesting a human being breathes atmospheric oxygen, while those who breath oxygen dissolved in liquid are not human?

Re:Ends & Means

[Stradivarius]

Using embryonic stem cells is not at all ethically questionable. They come from the left-over embryos from IVF treatments that would otherwise be thrown away or stored until someone else is willing to try using them.

So if someone dies, we should be able to harvest their organs even if they didn't volunteer them, because otherwise they'll just be thrown away and buried?

I think a lot of people would have ethical issues with that. Which is why we require consent for such things (and obviously an embryo can't consent itself, though maybe its parents could on its behalf)

The only way there is no ethical issue with embryonic stem cells is if you don't believe embryos are human beings, with the corresponding rights and dignity that go with being human. Which is of course what the whole debate is about.

Re:Ends & Means

[tthomas48]

Yes. All humans that I know of do. And all the ones that I've read about through history have.

But we're debating language not science. And I'm not helping things. I'll agree with you that zygotes are humans if you'll agree with me that gametes are half-human and maybe we can agree that this has jack to do with the issue of abortion.

I am curious where your science stands on babies with down's syndrome though. Since they're not human by the "measurable" standards of humanity you set earlier in this conversation.

Re:Ends & Means

[eabrek]

I don't know what "half-human" means. People with Downs syndrome are human beings (note the approx in my ~46).

I would define "human" as: "Any viable set of cells with common DNA and common experiences descended from a human." With all citizens of all countires grandfathered in as de facto "humans". So twins are two people (different experiences), parasitic twins are also two people, with a serious medical condition. You're arm is not (a whole, independent) human, but your upper torso (including your head) is.

The issue is not abortion per se, but what is means to be human, and when we confer rights on a human being.

Re:Ends & Means

[IICV]

By your argument, fertility clinics should also get the fertilized egg's consent before disposing of it, or before freezing it (which may lead to the destruction of the egg). We're already doing that no matter what; why is being used for science worse than being destroyed or frozen with only a slim chance of being revived before you are destroyed?

On the other hand, I think it is entirely appropriate to leave the decision of whether or not the egg can be used for science up to the egg's progenitors.

Re:Ends & Means

[tthomas48]

So a fetus with a genetic defect that causes it to not develop a heart is not human since it is not viable?

I think it's easier to confer rights on what I call a human - a homo-sapiens who has been born and is still living. And discuss the ethics of abortion, and various cell harvesting techniques on human cells as a separate ethics issue. It's really easier and more scientific that way.

Re:Ends & Means

[MillionthMonkey]

But perhaps that's because I don't enjoy viewing sex as genocide.

I had a cognitive leap in my teenage years.

Before then, I almost did view careless sex as genocide. Although I've never been like most idiots... People who are always looking for some instant in time [snaps fingers for effect] upon which they can neatly hinge their moral decision making- because before then it's cells, and after then it's a person, right? There is no moment like that, because zygotes only become people gradually. It calls for continuous judgment. But I did view it as more and more immoral as the kid developed. I suppose I still feel that way at some point during development, but I don't think human cells become persons with such ridiculous immediacy.

What makes a huge difference in your outlook, I think, is whether you realize that the abortion war is between people who have sex and people who don't. And as far as that goes, the greatest teacher is experience.

Re:Ends & Means

[eabrek]

Good catch. By viable I meant alive. If the cells are consuming resources, growing, and dividing, they are alive.

The problem is, you attach some sort of miracle to birth. There is nothing special about birth. The child at nine months inside the womb is nearly identical to the child already born. To make this distinction smells of special pleading.

Re:Ends & Means

[Jedi Alec]

So if someone dies, we should be able to harvest their organs even if they didn't volunteer them, because otherwise they'll just be thrown away and buried?

I think a lot of people would have ethical issues with that. Which is why we require consent for such things (and obviously an embryo can't consent itself, though maybe its parents could on its behalf)

Actually, now that you mention it, yes. Even though civilization might start with the way we treat our dead, getting all hung up about the sanctity of the human body once it's dead is really rather silly imo.

Then again, in my country we recently switched to opt-out wrt organ donorship...

Re:Ends & Means

[tthomas48]

Leaving aside the bizarre contention that there's nothing special about birth, I'm not talking about miracles.

I'm talking about a completely dependent bundle of cells proving it's viability and becoming an autonomous organism. That's not special pleading. If anything it's special pleading to say that a 9 month old fetus and a born baby are "nearly identical". They're very close to the same exact for the massive facts that the fetus is still getting all nutrition and oxygen through its mother's blood stream, floats in a sac of water and doesn't use it's digestive or respiratory system. Nearly identical, but ignoring massive differences.

Re:Ends & Means

[eabrek]

Being dependent doesn't make you not a person. We are all dependent on other people (farmers, oil workers, auto workers, grocers).

Nearly identical from an information theory point of view (DNA, life experience).

Re:Ends & Means

[tthomas48]

I could become a survivalist tomorrow and never depend on another human being again. That is a ridiculous comparison only made possible through the non-specificity of the English language.

A dead person is nearly identical to a living person from an information theory point of view also. Except they're dead. With none of the rights of a living person. Sure there are ethical concerns about what happens to a dead body. But the body is dead and is no longer a "person". Some bodies that are physically dead can be resuscitated through various means. At that point they are a "person" again. It's like the reverse of birth. Going from a non-person status to a person status. Like birth, in reverse.

Re:Ends & Means

[eabrek]

If you can be resuscitated, you're not really dead. Just unconscious (and dying). "Dead" should be reserved for people whose brains have degraded beyond any chance of resuscitation. Then you have an information delta (the information in their brain is lost).

Re:Ends & Means

[tthomas48]

So by your standard a person is not a person until they have developed a brain. And thus personhood does not being at the moment of conception.

Re:Ends & Means

[eabrek]

Not at all, as I said "information". New information is created at conception.

Re:Ends & Means

[tthomas48]

Decomposition rearranges chemical pathways and creates new "information" as well, in much the same way that an atrophying living body will. Cell division is still occurring. New cells are being created. Old cells are sloughing off. New pathways are created in the brain.

But you're doing a fantastic job defending a completely asinine arbitrary position. I look forward to seeing what you come up with next.

Re:Ends & Means

[eabrek]

1. Unless you have an absolute standard, all positions are arbitrary.
2. Your position is extrinsic (what can you do). It is a moving target, based on what those in power decide is good enough for you to earn your rights (say, "lawyers have full rights, while coders shall toil endlessly in the data mines").
3. My position is intrinsic (what you are). It can never be taken from you.

Patients aren't the only ones excited

[T Murphy]

Medical treatment that skirts federal regulations? Sounds like a lawyer's wet dream. Stem cell treatment has great potential, but they better tread carefully.

Re:Patients aren't the only ones excited

[fredjh]

The problem isn't with the treatment (as long as there is full disclosure to the patient), the problem is with federal regulators getting in the way of progress, as is increasingly common.

I'm wondering if people think progress like this will increase or decrease under "Obamacare." Yes, as a serious question.

Re:Patients aren't the only ones excited

[fredjh]

AC misses the point.

If the FDA approves something, after all that bureaucratic bullcrap, they damn well better be sure it's safe.

But if they haven't approved something, then it ought to ONLY come with a disclaimer that it either hasn't been approved or it's still be evaluated by the FDA, they shouldn't be able to RESTRICT it's use.

If I'm a cancer patient, dying and in pain, then F%$# you if you want me to wait ten years for some drug or therapy to be approved.

A Real Cowboy

[BJ_Covert_Action]

I can't speak to the medical benefits/drawbacks of stem cell therapies as I am not a doctor. However, I have to say that the attitude and gumption displayed by Dr. Centeno in his field is inspiring. Despite all the legal bullshittery and political asshatting going on around the country with regards to stem cell therapy, he managed to pioneer forward, develop some techniques and facilities, and find enough of a technicality to bring an actual treatment to his actual patients. That's a classic American cowboy attitude on display right there. He didn't let his exhaustion or cynicism get him down. He pioneered and worked hard and now ~80% of his patients are reaping the benefits. I have to say, that is very inspiring.

Folk like Dr. Centeno deserve a lot of recognition and thanks. I, for one, wish him luck. As soon as the blood-sucking lawyers get ahold of him, he's going to need it.

Re:A Real Cowboy

[MightyMartian]

I'm thinking it's bullshit, myself.

Re:A Real Cowboy

[idontgno]

In most sane and civilized contexts, "Cowboy" is not a compliment.

See also "loose cannon".

Re:A Real Cowboy

[vlm]

In most sane and civilized contexts, "Cowboy" is not a compliment.

Not fair to quote out of context. The problem is your subgroup of "sane and civilized contexts", has devolved into behavior that he (accurately and eloquently) describes as "legal bullshittery and political asshatting". Being aggressively rebellious against that sort of behavior is very complimentary.

Re:A Real Cowboy

[evilviper]

That's a classic American cowboy attitude on display right there.

Actually, I was thinking more along the lines of "Classic American Snake-Oil Salesman."

and now ~80% of his patients are reaping the benefits.

Nobody who has ever heard of a placebo puts any faith in the numbers provided. Without double-blind tests, we have no way of knowing if there is ANY positive effect, and we certainly don't know what the long-term consequences will be.

When we find these people getting WORSE, and perhaps developing cancer or other growths, the story will take a huge swing the other way: "Greedy doctor tricked desperate people into spending money on unsanctioned and untested medical treatment..."

Re:A Real Cowboy

[natehoy]

Unless significant numbers of his patients develop cancer, I have to agree.

Oh, wait, we don't know.

That's the point.

I wish him and his patients luck. But the fact is, he's risking his patients using this procedure. There's a very good chance the procedure will turn out to be safe, but .. there's a chance it won't. I certainly hope he's doing a better job of disclosing the risks to his actual patients than his PR firm is doing with this article.

And in that disclosure I hope he's mentioning that health complications brought on by unapproved procedures are not covered by most insurance policies, so if one of his patients develops cancer their insurance company has a really good way to disqualify them from coverage. Even if the cancer is unrelated to the treatment, the question can be raised.

I salute the doctor, and more importantly the patients, for taking the risks in the name of expanding medical knowledge. I hope they know that's what they are doing.

Re:A Real Cowboy

[fuzzyfuzzyfungus]

"classic American cowboy attitude"... "bullshit"... I think that we can reconcile these two positions fairly easily.

Re:A Real Cowboy

[ErikZ]

Screw Med school, I'm going to Placebo school!

Re:A Real Cowboy

[MightyMartian]

I'm thinking more "classic American snake oil". That's a part of the Western motif, too, and a part that seems much more fitting.

Re:A Real Cowboy

[BJ_Covert_Action]

A fair point. That's why I said I can't really testament to the medical benefits/drawbacks. I just find the attitude displayed by the doctor to be, while reckless, somewhat refreshing in the States these days.

Now, the article does say:

Importantly, RSI seems to be upfront with patients about the limits of their own technique. The website FAQ clearly states that not all results will be like the testimonials, and they even have a dedicated page explaining that stem cell therapies won’t work for everyone. Furthermore, RSI has published the largest study of risks and complications associated with stem cell treatments yet produced in the US (N=227). That paper demonstrates the very low harm associated with stem cell therapies – much lower than the alternative surgery(published in Current Stem Cell Research & Therapy).

Which at least seems to imply that Dr. Centeno is trying to be honest with his patients. Unfortunately, the paper linked to in the article (which claims to show that there are not harmful complications involving this particular therapy) is authored by Centeno. So its hard to say that the paper is unbiased. However, the full paper does appear to be available for download and is linked to in the article. I would hope that someone with a medical background would shoot it down if it is, indeed, BS.

At first glance, the major flaw that I can find in the paper is that it is based on a study where follow up times on patients treated was 10.6 months (mean, +- 7.3). That said, that probably is not enough time to see if cancer is going to develop in a significant number of the patients. At least, it doesn't seem like enough time to me. However, I don't have a biological background so I can't claim to know how fast it would take stem cells to develop into a cancer.

What it comes down to, therefore, is a matter of time. As you said, time will tell how dangerous/effective this particular treatment is.

I will still stand by my original claim, however, that this kind of, 'get-shit-done,' attitude is a refreshing break from the norm for US society. Sometimes progress requires risk. Sometimes those risks get the better of us and we all pay the consequences. Sometimes those risks get us to new heights. Dr. Centeno is, very obviously, a risk taker. His patients, too, are risk takers (supposing they have been properly informed about the subject). For that, I praise all of them, and wish them luck.

Re:A Real Cowboy

[natehoy]

His patients, too, are risk takers (supposing they have been properly informed about the subject).

Me, too, but I doubt they have been. You yourself have probably done more research than many of his patients, and what you've found would give the the screaming willies.

He's got an insignificantly-sized study that he authored himself stating that no complications happened over a short enough amount of time that the kinds of complications we're worried about wouldn't have happened yet?

Oblig. car analogy:

"In my study, which I did myself, 100 2-year-olds were sent off with cars onto the freeway. 75% of those 2-year-olds were still driving in a straight line and obviously enjoying themselves ten seconds after starting off. 25% of them drifted harmlessly into the breakdown lane and became stuck. So I can conclude that a great way to entertain a 2-year-olds is to have them drive on the freeway!"

The outcome of a study is frequently associated with the length of the followup term. That goes double for cancer-risk studies.

Re:A Real Cowboy

[geekoid]

He is a con man bring shit that doesn't work to the people. A modern snake oil salesmen who has a cure fro what ever ails ya.

YOU are praising a guy who can not back up his claims. He offers NO PROOF what so ever.

Re:A Real Cowboy

[DragonDru]

In most sane and civilized contexts, "Cowboy" is not a compliment.

See also "loose cannon".

In much the same way that "Republican" is a damning swear word. *Some* people like Cowboys.

Re:A Real Cowboy

[Ironhandx]

This is so true. Experimental treatments need to not have quite so many regulations around them. I agree that some regulations are necessary, but there are way way too many. It currently takes something like 10 years to get a drug from development just to the human testing stage plus another 10 to get it to treatment? Plus all of the expenses associated with even getting it into trials?

The whole process seems to be built around people with gobs of money abusing the system to make even more gobs of money. People yelling "Conspiracy" on the stem cell front have a good bloody reason to. Most people don't seem to have a single clue about how MUCH stem cells could potentially CURE. We're talking 10's, even 100's of billions of dollars of current drug/treatment revenue streams disappearing. There are trials in Canada right now that have cured people of cancer. Now, this is anecdotal evidence, but I know one woman who had lung cancer, the only treatment she received was the stem cells. She's cancer free right now. Nothing else would have saved her, the best they could do with other treatments was extend her life.

I mean shit, if they take the gloves off the research on this stuff who even /cares/ if it causes cancer in a few people, the more its used the better it will be understood, the faster it can be adapted and used to treat any new cancers it creates.

Re:A Real Cowboy

[BJ_Covert_Action]

In most sane and civilized contexts, rebel, hacker, and free thinker are not compliments either. Luckily for us both, the world is not always a sane and civilized place.

See also, "aristocrat"

Re:A Real Cowboy

[BJ_Covert_Action]

I would make a comment that folk shouldn't go through with such an invasive treatment without thoroughly researching the possible consequences. Then again, we are talking about folk with degenerative joint conditions that have been given the possibility to walk again. That said, I can see how the patients would have made a less than rational assessment. So, yeah, another fair point.

Re:A Real Cowboy

[Goobermunch]

Isn't that the nature of an experiment, though? I mean really, when you do the experiment, you don't have proof to back up your claims. You have a hypothesis.

Now, in his case, there is actually some proof. Apparently, these kinds of stem cell treatments have been shown to be efficacious in animal trials, right? So actually, there is some basis for believing that they will do so in human trials as well.

At the same time, however, he doesn't have data showing that his treatments work. But he is gathering that data and publishing his studies in peer-reviewed journals. So, in fact, he is engaged in the science of medicine.

In a few years, if he's right, he'll be a pioneer in stem cell treatment. If he's wrong, he'll have to face the legal, ethical, and professional consequences of his failed experiment.

But, I'm sure you'll agree, it's a bit hasty to claim that he is "a con man bring shit that doesn't work to the people." As you must acknowledge, there is no proof EITHER WAY as to whether the treatments work in human beings.

Please, do try to restrain yourself from defaming people you don't know.

--AC

Re:A Real Cowboy

[Goobermunch]

Great. How do we get the data for those long-term studies?

Do we do the experiment and then check the patients for an extended period of time? But before we can get there, we have to do the experiment.

Also, how do you know what Dr. Centeno tells his patients in the process of obtaining informed consent. I know the man professionally, and have found him to have the highest ethical standards. I don't know the precise information he provides when he obtains informed consent, but neither do you.

--AC

Not to be the bad guy but...

[00Sovereign]

As a biomedical researcher, I'm glad to finally see some of the promises of stem cells. However, this must be tempered by knowing that there exists a fine line between stem cells and cancer cells. Both grow outside of the normal controls that keep excess cell division in check. For stem cells, this is developmentally controlled by the neighboring cells. I wonder how these stem cells will respond when moved to a new environment and what the long term effects will be. I guess that FDA sanctioned or not, we're going to find out.

Re:Not to be the bad guy but...

[droopycom]

Unfortunately, since this seem to be limited to one practice which claim they are not regulated by FDA, I'm not sure we will ever see a serious study on the long term effects of their treatment.

It looks like they are basically operating outside any control...

Re:Not to be the bad guy but...

[jbeaupre]

As someone who has made stuff regulated by the FDA, I can shed a little light on what they regulate.

The first rule of thumb is that doctors can do any medical treatment. There are rules and customs that limit doctors on what they do, but legally once they are a doctor, they can do pretty much anything. So in theory, a podiatrist could do brain surgery (if he could find a patient dumb enough, a hospital dumb enough, staff dumb enough, etc). States tend to have enough rules to prevent it, but they aren't as rigid as you might imagine. And it does mean that doctors can prescribe pretty much any chemical legally available, and some that aren't

The second rule of thumb is that the FDA regulates drugs and devices, not treatments or surgery. Some people argue that autologous cell transplants are surgery maybe with a few drugs tossed into the mix. You're just moving stuff around and using drugs.

The third rule of thumb is that the FDA focuses on medical claims. You've heard the term "off label use?" It means that the product is approved for market, and cannot be marketed as useful for anything but what it was approved for, but doctors can use it for something else. Botox used to be sold that way. Even mentioning off label use by a company is a big no-no.

So what you have here is a doctor, who can do pretty much what he wants, and may not even subject to the FDA. But if his company is making marketing claims, the FDA might still go after him (presumably he is an officer of the company, which makes him subject to criminal arrest by the FDA. Unlike ISO, FDA agents carry badges and can slap cuffs on you)

Re:Not to be the bad guy but...

[Chris Burke]

I wonder how these stem cells will respond when moved to a new environment and what the long term effects will be. I guess that FDA sanctioned or not, we're going to find out.

But are we? That's my question.

Somehow I doubt a Doctor who has already decided that their treatment is safe and effective enough to give to paying customers in spite of the FDA is going to be worried about making sure his practice also constitutes a valid long-term scientific.

I mean I don't know exactly what he's doing, but I think we can rule double-blind clinical trials right out. If what he was doing was even close to the kind of research that the FDA requires before approving something, then it seems like it wouldn't be that hard to go the extra mile and apply for approval. Getting FDA approval is expensive, but a lot of that is because valid, meaningful clinical trials are expensive. Which is why I doubt he's doing them.

What I worry about is that when all is said and done, we still won't know anything more than the anecdotal testimonials of his happy customers, and maybe some other anecdotes from people who claim he gave them cancer.

You're a medical researcher, what do you think the odds are that simply looking at a practicing non-research physician's records after ten years will duplicate the work that actual medical research would have produced?

Guns and weed, too. How big is this trend?

[BenEnglishAtHome]

Per the article:

They claim that Regenexx is solely used as a part of their medical practice, only within the state of Colorado (emphasis added), and as such is no more regulated by the FDA than it would be by the FAA or the Department of Motor Vehicles.

So at least part of their legal claim that the FDA can go jump in the lake is based on the notion that their work is limited to one state. Others are saying the same thing. Gun-rights activists are pushing legislation, some of which has been passed into law to make firearms made and sold in a single state exempt from federal regulation. (That's an odd link, but it was one of the first I found. Google a bit and you'll see lots of pages devoted to this stuff.)

How many other issues are being pushed in this way? There's medical marijuana, of course, (I didn't figure I needed to find a cite for that one) but are there any others?

I'm curious about how widespread this trend is.

Re:How great

[Red Flayer]

Helps if I screw up the link when I try to insert it (boo me, I forgot to preview).

Document referenced in above post is here.

Re:No Surgery Required?

[fahrbot-bot]

They harvest a small amount of your own bone marrow, extract the stem cells from it, and inject them into the spots where they are needed.

With the addition of one more step in that they cultivate the stem cells after extraction to increase their numbers before re-injection. Many other clinics already do extract, spin, inject. The higher numbers of stem cells after cultivation is what they say improves their effectiveness rate.

Misleading Summary

[sycodon]

Summary: ...allowing many patients to walk or run who have not been able to do so for years

Reality:
Within months some patients can walk or run in ways they haven’t been able to in years.

What is this? A late night infomercial?

Re:Misleading Summary

[Anonymous Coward]

What is this? A late night infomercial?

No, those have editors.

Re:Misleading Summary

[kkleiner]

Good point. Should have been "allowing many patients to easily walk or run who have had difficulty doing so for years

Re:Misleading Summary

[garcia]

What is this? A late night infomercial?

Depends on your timezone I guess.

Re:Misleading Summary

[Anonymous Coward]

It is a late night informerial.

They are neglecting many of the serious health implications of effectively cloning a few stem cells into many (copy erros occur). I can count at least 30 scientific flaws in the data they present, and ever more suspect items (such as the 'journal' they published to).

I will be glad once the beast known as the FDA gets on them :)

Re:Misleading Summary

[longhairedgnome]

The FDA doesn't control drugs worldwide

Re:Misleading Summary

[repapetilto]

why is this insightful? While everything the AC said may be true and sound like informed skepticism, nothing is said to support his claims...

Re:Misleading Summary

[h4rm0ny]

It is not a late night infomercial, it's just the usual piss-poor editing hyping stuff up. Don't know why you got an insightful mod - TFA is actually quite candid about the facts of the matter and also links to a paper examining possible risks. They aren't making wild claims like the summary and are shortly publishing a peer-reviewed paper detailing their results.

The particular item of interest not alluded to in TFS, is about two-thirds of the way down and is this:

The FDA seems to have taken the stance that all stem cells (whether used autologously or not) are drugs. As such, they would need FDA approval, and would likely only be developed by large pharmaceutical companies.

That might partly explain the delay in delivering this therapy to humans - the big pharmaceuticals want in on what could be an enormous opportunity to make money out of people. As usual.

Re:Misleading Summary

[h4rm0ny]

Argh! Apologies - the last paragraph was not intended to be quoted - it was not from the article, those are my words.

Re:Misleading Summary

[longhairedgnome]

I found your language to be loaded and ignorant. Thats what prompted me to comment it in the first place, let me call the wahhhhhhhmmmbulance for you, now I read some butthurtness

Re:Misleading Summary

[longhairedgnome]

blah blah blah

Good luck with that

[Hatta]

They claim that Regenexx is solely used as a part of their medical practice, only within the state of Colorado

If the Supreme Court can rule that a man growing and consuming wheat entirely on his own property is covered by the Interstate Commerce Clause, then everything is. The FDA will have no problem asserting jurisdiction here.

Re:Good luck with that

[nedlohs]

Except that that reasoning doesn't apply in this case.

Not that that will matter of course, but it isn't a slam dunk by that case.

Re:Good luck with that

[Anonymous Coward]

Let me guess... You are not a lawyer.

The case you cited did indeed happen. However, you left out a VERY important word.
"

man growing and consuming excess wheat entirely on his own property is covered by the Interstate Commerce Clause..."

Roscoe was growing and selling wheat on the open market, and then claimed that only the excess was used for him. See the difference?

Re:Good luck with that

[StikyPad]

Exactly. This same ruling has been the bane of medical marijuana efforts vis-a-vis the DEA, as well as countless other seemingly local matters that are extrapolated into Federal affairs -- quite literally. By the rationale of Wickard v Filburn, for those unaware, anything that affects or potentially affects supply and demand on a national level (which is literally everything), is subject to the Interstate Commerce clause, and thus falls under Federal jurisdiction. If you're growing wheat locally, consuming it locally, and disposing of it locally, you're affecting demand for products from out of state. If you're growing marijuana locally, then you're affecting the government's ability to regulate the market for marijuana nationally (where elimination is a form of regulation). Likewise, if you're performing a procedure in Colorado, you're affecting the government's ability to eliminate the market for that treatment on a national scale.

This is clearly beyond the intent of the framers, as indicated by all available documents of the period, but laws often have unintended consequences. Many people blame the USSC, although essentially they did their job: They said, "Well, this is simply an unintended consequence of the law, but the law is still valid." The real problem, as always (in a democracy) lies with an electorate which either does not know or does not care about the rights they are willfully surrendering. The feet of Congress should be held to the fire to narrow their jurisdiction and to tailor laws as specifically and narrowly as the Supreme Court tends to tailor its decisions these days.

Note that I'm not holding my breath...

Re:No Surgery Required?

[Aeros]

Having dealt with bad back issues plus working only 20 minutes away from this place I kind of want to check them out. Unfortunately I can't afford that kind of dough ... bummer.

Re:How great

[clarkkent09]

That "one daring little company" is gonna get shut down, which is a good thing. Clinical testing of their treatment method has yet to be completed, and a lot of people could get hurt if it turns out there are problems.

In general I agree, you have to do clinical tests. However, I don't see why patients should not be able to voluntarily accept this or other untested treatments provided that a full disclaimer is made. In a case where the approval of a treatment with a great deal of evidence in it's favor has long been delayed due to political or religious reasons as is the case with human stem cell therapies, working around the FDA might be a good thing.

Countdown...

[kenp2002]

beginning countdown till a lawsuit drives the cost to do so so high that only the elite can afford it... lawyer litgation gold rush in 10... 9... 8...

Face it, without real tort reform this will get litigated into oblivion...

Americans skirted the FDA for years, via Mexico

[snadrus]

Right on the other side of the border are fancy all-English-speaking hospitals with American doctors doing procedures the FDA bans.

As long as you're avoiding regulation, go where it's been done for years.

Daring? Really?

[DesScorp]

Finally. One daring little company, and we finally move forward. Thumbs up for the Colorado mavericks.

Medical history is replete with "mavericks" that hawked miracle cures. The common thread was their claim that the Man was engaged in a conspiracy to surpress their wonderful new miracle treatment. You may or may not be too young to remember the whole Hydrazine Sulfate scam. Bob Guccione (the publisher of Penthouse) sent his wife to a quack named Dr. Joseph Gold, who sold them on Hydrazine Sulfate... formerly an industrial chemical... as a miracle cancer treatment. Guccione railed in Penthouse about how the National Cancer Institute was suppressing this vital new treatment out of greed and jealousy. His wife took the stuff anyway, telling everyone how much better she was feeling.

She died of breast cancer soon afterwards. And to this day, the FDA says there's no evidence for the benefit of that compound.

I'm well aware that sometimes a clique mentality can settle in among scientists. They're human, after all, and are as fallible as anyone else. And in the end, perhaps these stem cell guys will be hailed as heroes. But when someone is crying "conspiracy!", I'd at least be careful before taking what they're selling.

Re:Daring? Really?

[wizardforce]

It is very difficult to protect people from themselves. The drug war being a good example of this.

Re:It's a shame...

[natehoy]

Embryonic stem cells had nothing to do with this. Read the article. They are extracting stem cells from the patient.

This has been delayed because of the risks to the patient, not because of the pro-life/pro-choice debate.

Re:No Surgery Required?

[natehoy]

Stick with the back pain for now. Stem cells are still in the experimental stage on humans, hence this doctor's flaunting of FDA regs.

Unless you have a particular desire to be a guinea pig, or your quality of life is so poor that it's worth the risk of dying of cancer (and having your health insurance able to bail out on coverage because you had a non-FDA-approved procedure that contributed to it)...

Re:Guns and weed, too. How big is this trend?

[schon]

So at least part of their legal claim that the FDA can go jump in the lake is based on the notion that their work is limited to one state.

Unfortunately thanks to Wickard v. Filburn, while they are factually correct, they are not legally correct. Basically the Supreme court ruled unanimously that if you make something that someone in another state sells, it can be regulated by the Federal government under the Interstate Commerce clause of the constitution.

Re:No Surgery Required?

[Aeros]

yes some days its a toss up. Well i cant afford it so it wont happen but I definitely will keep an eye on this company to see where they go. Will be interesting to see where this goes.

Political Landscape

[MortimerGraves]

> Are there really people who believe the lump of cells has a soul, but it is okay to destroy it to fix cancer in papa?

No necessarily. The efficacy of the treatments may or may not change the moral position of individuals but is likely to alter the political landscape. Consider the hypothetical position of a Politician before and after stem cell treatments shown to be efficacious:

[Before] Politician faced with one vocal constituent who believed that the "lump of cells has a soul' along with two apathetic ones.

[After] Politician faced with same one vocal constituent who still believes that the "lump of cells has a soul' along with two who are clamouring for treatments to be approved to "fix cancer in papa".

fetal stem cell use & research not illegal

[SethJohnson]

Just to be clear here. I'm not formally involved in this field, but I not believe that research using fetal stem cells is illegal. The only restriction I know of is that federal funded research can only use certain pre-existing strains of cells.

You might think this was spearheaded by christian lobbying groups. Nope. They were pawns and puppets of pharma. This was a field showing great promise. If federal dollars developed tools and procedures to use stem cells, that technology would exist in the public domain. The right-to-lifers' perspective was amplified to hide the real agenda-- keep stem cell therapy research in the exclusive hands of the private pharma corporations. The resulting proprietary treatments will be far more expensive and lucrative than if the federal government had made the breakthroughs in this science.

Seth

Baby Eating Advocacy

[srobert]

I'd have to say that I'm opposed to this "baby eating" that you advocate, laser-vision notwithstanding.

Re:How great

[wizardforce]

That is a good idea but I doubt that there's much chance of it being allowed for any amount of time because it doesn't allow for forcibly protecting people from themselves. See the drug war for details.

Re:How great

[Red Flayer]

It's not just the FDA (thought the FDA can be involved).

The Colorado State Board of Medical Examiners is the oversight board for medical practitioners in CO. Among other things, the SBME uses FDA guidelines for common treatments in order to determine whether a specific practice falls within allowable treatments by a licensed practitioner.

So regardless of whether the FDA steps in directly, FDA regulations apply to how the State of Colorado enforces its licensing system. Typically, by default, treatments proscribed by the FDA would be considered to NOT be a commonly accepted medical treatment, and thus a medical practitioner using that treatment would be subject to sanctions by the Colorado SBME.

Re:How great

[TooMuchToDo]

I have to agree. If the FDA is there to protect me, I should be able to sign on the dotted line to accept treatment that may kill me or may heal me (as long as I waive the right to sue, etc).

Re:How great

[Mirlas]

In general I agree, you have to do clinical tests. However, I don't see why patients should not be able to voluntarily accept this or other untested treatments provided that a full disclaimer is made. In a case where the approval of a treatment with a great deal of evidence in it's favor has long been delayed due to political or religious reasons as is the case with human stem cell therapies, working around the FDA might be a good thing.

This is actually how medical research studies are performed. The process is called "Informed Consent" and the prospective participant is given a full rundown on the proposed treatments, including a full disclosure of possible risks. However, the research study itself has to conform to various regulations and is subject to the oversight of various bodies who approve the study protocol and also the materials used in the consent process. There are quite a number of hoops to jump through prior to enrolling participants in the study. On the other hand, offering an unapproved procedure as a treatment, rather than as the subject of a research study is a different thing entirely.

Re:How great

[CptNerd]

What religious reasons have been used to prevent adult (autologous) stem cell research (which this apparently uses)?

Re:Guns and weed, too. How big is this trend?

[faboo]

Um, all of them? That's how it was supposed to work, you know, when we put together The Law (that'd be the Constitution): The federal government gets a small, well-defined set of powers, and the states decide everything else individually. In practice, however, the Feds use the interstate commerce clause to lord over anything and everything you might toss over a border.

Re:FDA is a joke

[GodfatherofSoul]

The FDA doesn't exist to stop you from killing yourself. It exists to stop businesses from killing you.

FDA, What purpose?

[SolarStorm]

A theme I read in many of the replys were centered around "I should be able to make my own choices". Yes to a certain extent. But how many of these people will run back to the gov't when they develop bone cancer? How does the average person who has trouble with their VCR make an informed decsion on a new experimental medical procedure. Medicine will turn into (if not already there) a salemanship game. "Cures baldness, impotence and raises IQ's, come one come all, only 10 cents". The FDA ensures a standard of research and documentation required to provide some common level of proof. Its not perfect, but I dont trust the masses to make informed decisions. There were a whole bunch of women who thought Thalydimide was a wonder drug, until their babies were born. But for every bad story there is also a good one. If the treatment has the success purported, why not get some investors, and get the approval required and own the procedure, instead of the cowboy approach. This is only going to lead to a legal battle, someone else will find the investors, but the treatment itself could end up in court for years as well as the FDA process.

Odd, Colorado of all places?

[scorp1us]

I'll finally be able to clone a Shakey's, and have one for myself!

Re:ABOMINATION!

[PIBM]

Was that supposed to be funny ? Sarcastic ? Or are you really trying to bring this down with people beliefs ?

Re:How great

[c 0xFF]

And don't forget that you miss out on a ton of research data by using unapproved procedures instead of going through a proper research study.

If the patients from the article get cancer (or other complications), it would be a shame for the rest of us if not enough data was collected beforehand to identify risk factors, etc.

Sham Surgery?

[meehawl]

I am unimpressed by that MRI image before-and-after, which simply shows localised swelling resolving later on. Cancer risks have been explored enough in this thread, but what about any randomised testing against placebo or sham surgery? It's not like orthopaedics hasn't had repeated booms in lucrative, minimally invasive "treatments" that RCTs have later shown to be no better than placebo, or worse if you take the risks into account.

I smell quackery...

[assert(0)]

http://www.quackometer.net/?suspectquack=Dr.+Centeno:

This person may be associated with Quackery.

Re:How great

[dmoynihan]

Yeah, they'll probably get shut down. And I too look askance at the firm's claims.

On the other hand, FDA's constant ass-dragging (largely a bureaucratic procedure to protect themselves from criticism) means in the future rich people'll be going to China/India for similar treatments, as they already are for certain U.S.-invented cancer treatments that never could get approved here (thinking Onyx-015, but there are dozens of examples).

Patients of this firm should be well-informed of all risks, and allowed to go for it should they so choose; screw your paternalism. /And no drug testing beyond Phase II. //I know, I know, FDA halted thalidomide, saving hundreds. And how many hundreds of thousands have died in the extra years it takes for cancer-fighting biologics to hit the market, after such products had shown efficacy?

Experimental medicine licensing

[Beryllium Sphere(tm)]

>I personally think people should be permitted access to experimental medical procedures, as long as they understand that as they are experimental, they're waiving their right to sue for wrongful death or medical malpractice, as well as any federal mandate for it to be covered by their insurance.

_Astounding_ editor John Campbell once suggested that quack doctors should be allowed to practice under a special quack license, which would alert patients to the fact that they weren't going to a mainstream doctor. He added a really interesting wrinkle, which was that a quack license would be conditional on keeping lab-grade records of treatments and results, so that quack treatments would get empirical testing with informed volunteers.

Re:How great

[Dr_Barnowl]

The problem is the matter of informed consent.

I have a medical degree, and an understanding of molecular biology. I therefore understand the potential consequences of the treatment.

What I don't understand, and what no-one can until extensive trials have occurred, are the risks, which are not quantifiable without statistical data. Since the risks are the only information accessible by those people without an understanding of molecular biology and medicine, there can be no informed consent by the layman.

There is a third option

[NotSoHeavyD3]

The middle road of course. That the idiot came up with a treatment that doesn't really do anything except the complications of having a big freaking needle shoved in a joint. (Which will probably amount to quite a bit of pain, some infection, some bleeding, but mostly just waste alot of the patients' money.)

Re:There is a third option

[natehoy]

You do realize, of course, that stem cells don't always turn into what scientists want them to?

The short-term complications are as you describe, but the long-term complications could include cancer.

Re:There is a third option

[NotSoHeavyD3]

Yes I realize that. They could turn into what the scientists want, they could turn cancerous, or they could just die.

Commerce Clause will do them in

[Rene S. Hollan]

They claim to skirt the FDA because they operate solely in state.

The Commerce Clause of the U.S. Constitution serves to ensure that there are no inter-state trade wars (e.g. due to tarrifs at state borders).

However, it has been used broadly within states when an argument can be made that internal commercial activities affect commerce outside the state's borders.

In this case, it could be argued that stem-cell treatment within Colorado affects the markets for prosthetics outside of Colorado and therefore falls within the purvue of the Commerce Clause.

You can read more on the Commerce Clause but the main problem is that the Feds decide what constitutes "commerce". In fact, the Commerce Clause has been use to require sex offender registration outside the states where they were convicted. This is a contentious issue and the circuit courts are split on the matter, leading to a likely ruling by the U.S. Supreme Court (expected in 2010).

Re:How great

[Artagel]

The FDA has known about this for quite a while... http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/ucm091991.htm And yes, there is a Mr. FDA Man. The Office of Criminal Investigations. http://www.fda.gov/ICECI/CriminalInvestigations/default.htm They tend to prioritize based on danger to the public, so at least they have not lumped him in with the adulterated-drug people. Yet.

Re:FDA is a joke

[natehoy]

The FDA has not approved this, because they have not tested it and do not know if it is effective AND safe.

You may feel free to continue to get this kind of treatment, and take the risks that are involved in it. The FDA exists to make sure you are aware of those risks, and to stop businesses who make unsupported claims from doing so. Your insurance company can also deny any claims you may make that could feasibly have been caused by buying this procedure.

This guy is making claims that are currently unsupported by a properly documented body of science, selling a procedure that has not been fully tested in humans and may have unknown side effects, including death by cancer. The FDA exists to make sure that, should you choose to engage in a procedure, you understand the risks involved in that procedure and how likely it is you will benefit.

You may continue putting your stem cells where you please. No one says everyone who does things to you needs to be a doctor. Maybe along with chiropractor, homeopathic consultant, and crystal therapist, we'll have a stem cell therapy technician. But understand that your insurance company might not be terribly happy with you making body modifications they don't understand and haven't been approved, so if you come down with cancer and it metastasizes from your knee to your liver, they aren't on the hook for the millions of dollars it will take to make you comfortable in your last few years.

The FDA exists to try and identify what things are good for people, and what things can harm them. They try to encourage the former and discourage the latter. If something is harmless but not effective, they allow its sale as long as no claims are made that cannot be supported. If something is harmful, they have the power to regulate its sale and use. Until something is proven safe, it is necessary for them to treat it as potentially harmful.

If you don't like the nanny state bullshit that involves, please do feel free to engage in any treatment you choose. You want to go off and engage in experimental and unproven stuff and you've got the money? Go for it! I'm not trying to be mean, though, when I say that if it doesn't work out for you please don't expect my insurance rates to cover you on it, and don't expect a lot of sympathy.

If this doctor is not disclosing the risks of the procedure to his patients, he must be stopped until he discloses the risks fully. If his patients are knowingly taking this risk, then more power to 'em.

Re:Guns and weed, too. How big is this trend?

[corbettw]

Wickard v. Filburn dealt with a fungible commodity (wheat). This guy is performing a specific service that must be done under specific circumstances, so Wickard may not apply. Regardless, I'm sure we'll find out when the FDA comes knockin' in the not-too-distant future.

Re:Guns and weed, too. How big is this trend?

[Artagel]

This is first-year constitutional law in law school. Wickard v. Filburn. http://en.wikipedia.org/wiki/Wickard_v._Filburn This is during the Roosevelt administration. Roosevelt is trying to keep supplies of food low so the price stays high enough for farmers to stay in business as opposed to prices dropping until they are all out of business. Filburn grew wheat for his own use to feed his own chickens. The idea was that since Filburn was not buying from the limited supply of wheat allowed, he was depressing prices in interstate commerce. The Supreme Court accepted this argument. This has been the basis of interstate commerce ever since with just a few notable exceptions. (United States v. Lopez for example. Ok, you say, this wheat and chickens things is silly. But what about a meal at a lunch counter? Guess what. Civil Rights laws depend on this expansive notion of Interstate Commerce. This is not a small or trivial issue. The doctor will not win it.

Re:No Surgery Required?

[natehoy]

I hear ya. I have a few friends who would benefit greatly from something like this, and one just ended up taking some really risky surgery (for her) so she could start exercising and get healthy enough for knee surgery. Something like this would be nothing short of miraculous.

I honestly hope this works out, and all the current patients do well and end up with normal cancer rates, and in a decade or so this becomes a commonplace treatment.

But I'd have to be in a big shitload of pain and wealthy enough to pay my own medical bills from here on in to take a risk on an untested procedure.

Re:How great

[Hurricane78]

Finally. One daring little company, and we finally move forward. Thumbs up for the Colorado mavericks.

Hah. Shutdown pending in 3... 2... 1...

Better than you, asshat! I bet you would have said the same about the guy who tried to assassinate Hitler.

Cut your crab mentality! An attitude like yours is the reason we can’t change anything in the countries of the world. It’s the reason people did not stand up and chased Hitler, or Mobutu, or Cheney, or Kim-Jong Il or Stalin out of the country.

You should be ashamed of yourself. If only for not doing something.

Re:How great

[RobinEggs]

...I don't see why patients should not be able to voluntarily accept this or other untested treatments provided that a full disclaimer is made.

Because even with full disclaimers which absolve the patient, doctor, or insurance companies of various liabilities, it's still everyone's problem if the tests go horribly wrong. We're not actually going to ban them from insurance coverage or Medicare payments for side-effects of the experiments based on those waivers; even if they signed a document to accept the risk it would be disheartening, distasteful, and somewhat inhumane allowing them to suffer untreated for decades, or die in agony, should the treatment end horrifically.

Re:How great

[Stradivarius]

The problem is that by protecting the desperately ill against snake oil salesmen, you're also "protecting" them from legitimate cures that could save their life.

It really comes down to who owns your body - you, or the government? Right now our system says the government does.

It doesn't matter if you're terminally ill, and have tried all the approved treatments to no avail, the FDA still denies you potentially life-saving care. So rather than having a, say, 90% chance of dying from the disease, they guarantee you have a 100% chance of dying from it. That's not protecting patients.

I think most people would be fine if the FDA said you had to try all the approved alternatives first. But if you've tried all that and nothing works, then they shouldn't forbid you from trying something experimental. Because at that point, they're not protecting you, they're killing you.

Re:No Surgery Required?

[Civil_Disobedient]

hence this doctor's flaunting of FDA regs

The word is flouting, FYI.

Re:How great

[frank_adrian314159]

I don't see why patients should not be able to voluntarily accept this or other untested treatments provided that a full disclaimer is made.

Because until the studies are done, you don't know the limits of disclaim. I tell you there's always some chance you'll die in five years from cancer - hey! I don't know any different and, besides, people always find ways to die. Then, in four years, when 75% of the patients are turning up with cancer, you're PO'ed because now you're going to die in a year. More importantly, because this doctor is now being sued into oblivion by people who felt that 75% > "some", your medical costs are going to be picked up by someone else. And, I doubt you're going to go as far as to say no to palliative care, let alone the possibility of having the public (or others in your insurance pool) pay for actual treatment of iatrogenic illness brought on by your desire to experiment on yourself.

Yes, the FDA approval process sucks. In fact, it is the worst one around, except for all the other ones.

Re:No Surgery Required?

[besalope]

Stick with the back pain for now. Stem cells are still in the experimental stage on humans, hence this doctor's flaunting of FDA regs.

Unless you have a particular desire to be a guinea pig, or your quality of life is so poor that it's worth the risk of dying of cancer (and having your health insurance able to bail out on coverage because you had a non-FDA-approved procedure that contributed to it)...

They've been doing this type of stem cell work in Asia and Europe for awhile. The FDA is cock-blocking quality care for no good reason. The tech has been proven to work in other countries, and it's about damn time we start playing catch-up.

There was a young girl (middle school) about a decade ago that had been dropped from a cheerleading pyramid at a rally back in my hometown. She was paralyzed from the neck down. A couple years ago her family took her to China to get stem cell therapy to begin restoring damaged nerves, and from what I've heard it's working.

Re:No Surgery Required?

[Anachragnome]

"These are autologous stem cells (meaning YOUR OWN). No harvesting from anyone other than you."

And, finally, we come to the heart of the matter.

TFA states: "The FDA seems to have taken the stance that all stem cells (whether used autologously or not) are drugs."

THIS is what is at issue here. The good Doctor is simply forcing the FDA into a position to either back down from that assertion or validate it somehow. He is forcing debate on the issue.

Just what, exactly, constitutes a drug. The Doctor argues that this is a "treatment" or "therapy", no different then a skin-graft or banking your own blood supply, and he makes a valid point. The actual substance used is from the body it came from. Did it become a "drug" simply by removal from the patient's body?

MASSIVE amounts of money are on the line here, especially if the very definition of the term "drug" is altered as a result as it would also alter the markets associated with drugs. The BigPharma are already trying (and succeeding) in getting patents for stuff that we ALL already possess, and seek to make a profit from those patents.

Who, exactly, do you think their competition will be in this market? Who ELSE might be able to supply YOU with the stem cells needed for such treatments? You! The only viable means the Pharma have to compete is growing their own supply and then make it harder to use your own cells. Enter the Lobbyists and FDA Guideline Revisionists.

I hope the good Doctor has good lawyers.

Reporting bias...

[clone53421]

If this had been done with embryonic stem cells, I have little doubt they’d have prominently featured this in the headline. But since it was an adult stem cell treatment, this pertinent fact is not considered worthy of mention in the headline, or even the summary.

And then there are the typical responses about how the evil Republicans were trying to prevent these treatments just to save a few embryos, which of course are completely irrelevant because no embryos are involved in these treatments and Republicans, to my knowledge, are not opposed to research in adult stem cell treatments.

In fact, the whole situation here was that the typically slow-moving FDA just hasn’t decided whether the treatments are safe yet.

Re:Reporting bias...

[eabrek]

Well said, clone.

Re:Reporting bias...

[clone53421]

At last, someone understands me.

Re:Reporting bias...

[Slashcrap]

And then there are the typical responses about how the evil Republicans were trying to prevent these treatments just to save a few embryos, which of course are completely irrelevant because no embryos are involved in these treatments and Republicans, to my knowledge, are not opposed to research in adult stem cell treatments.

LOL, you think the average Republican would be willing or able to understand the difference? No. The top few percent of Republican intellectuals would be able to understand it, but why should they be willing to understand it when failing to do so lets them rant about liberal baby killers? You talk about them like they're rational people, for God's sake.

Re:Reporting bias...

[clone53421]

True to your name, slashcrap.

Re:No Surgery Required?

[natehoy]

Oops. You're right. Thanks for the correction.

Bad Logic

[Prien715]

If the Supreme Court can rule that a man growing and consuming wheat entirely on his own property is covered by the Interstate Commerce Clause, then everything is. The FDA will have no problem asserting jurisdiction here.

He was feeding the wheat to the chickens he on the open market. It's not exactly "self-use" if you're using it to make another product you then sell. Any other ruling would have forced all chicken growers to grow their own food since they couldn't compete in the market otherwise.

So, who is more evil ?

[frog_strat]

A company rushing a new treatment to make quicker money. Or an malfunctioning government agency that often resembles a whorehouse ?

Re:Guns and weed, too. How big is this trend?

[TheSync]

But what about a meal at a lunch counter? Guess what. Civil Rights laws depend on this expansive notion of Interstate Commerce.

Really? What about the 14th Amendment ("No State shall...deny to any person within its jurisdiction the equal protection of the laws.") ?

(that and I'd hope that most states have their own Civil Rights laws as well by now)

Re:How great

[moosesocks]

Because the decisions we make about our own health often extend far beyond our own lives, whether we want them to or not.

If you consent to the procedure, you also need to make sure that your spouse and children also consent to giving you the treatment, as they're the ones who are going to be forced to care for you if you become severely ill as a result of the treatment.

The FDA has historically been very good at what they do. I'd be inclined to trust their word.

Re:How great

[geekoid]

I like how they thing that if you had a Jumbo Jet, and never left the state, the FAA wouldn't apply to you.

Re:How great

[geekoid]

Because the test isn't controlled properly if you do that.
People won't make good decisions, they will make knee jerk decisions based on a lack of understanding statistics, and emotional appeal.

Plus, a good sales person can hook just about anyone into buying anything.

Re:How great

[geekoid]

Been tried, hucksters convince people to sign and explain details in a way that may make them sound better, but arent..

There are people out there that make spammers seem like angels. Think about social engineering.

I sued to agree with you. Then, for completely different reasons, I did some research into pre FDA medicine. Ho-boy. SO many people dies because someone lied to them, or explained thing is a positive way.
Add to that the fact that most people are not trained to think logically. They think they can, but they can't.

Re:How great

[geekoid]

You should be ashamed for posting your statement using an emotional appeal instead of logic.

Of course, if you could actually use logic, you would understand why you are wrong.

The reason nothing is getting change is because the Republican refuse to do anything or cooperate in any way.

Even when the republican propose a bill, they will refuse to vote for it if Obama says he will sign it.

What kind of fucked up party does that?

Re:No Surgery Required?

[Chris Burke]

Just what, exactly, constitutes a drug. The Doctor argues that this is a "treatment" or "therapy", no different then a skin-graft or banking your own blood supply, and he makes a valid point.

Well I don't know what the correct legal ruling would be vis a vis the FDA's mandate and the definition of "drug".

What I do know is that I think that treatments and therapies should be required to demonstrate both efficacy and safety in controlled clinical trials before they're allowed to be administered at your physician's discretion. I don't think that this should only apply to drugs, because obviously drugs aren't the only thing that can potentially harm you while providing no benefit.

Take this procedure for example. I would agree that stem cells, particularly your own stem cells, are not a "drug". Yet this procedure carries significant hypothetical risk of cancer, and the actual risk is unknown. But because it's not a drug, it's a "therapy", this shouldn't matter and this doctor should be able to administer it to anyone who wants it?

I don't buy that.

Safety and efficacy are issues that apply to all medical procedures.

The only viable means the Pharma have to compete is growing their own supply and then make it harder to use your own cells. Enter the Lobbyists and FDA Guideline Revisionists.

Okay I hate Big Pharma as much as anyone, but the FDA is not why Big Pharma is your only source for certain drugs and treatments. That's the patent problem you mention. If the FDA approved this procedure, then there's nothing stopping your doctor from extracting your own stem cells and using them without Big Pharma getting involved.

I hope the good Doctor has good lawyers.

I hope that behind the facade of a guy selling treatments for profit and a web page full of schlocky-sounding testimonials, he has a team of good medical researchers performing the actual double-blind studies needed to quantify the risk/efficacy issues, and if the results come out contrary to what he has assumed, that he'll stop.

But since I'm doubting that's the case, yeah, he's going to need good lawyers.

Re:No Surgery Required?

[ars]

They can't.

This is probably not patentable, and therefor no one will do the necessary trials to get it approved.

Unpatentable but useful procedures are a big hole in FDA policy, and I think the whitehouse should fund the HIH to get approvals for such procedures.

Re:Guns and weed, too. How big is this trend?

[lwsimon]

As part of the firearms community, there have been high profile cases dealing with machine guns, food products, and narcotics that have reached the community's radar, so to speak.

There was a guy a while back that made a Sten - a simple but effective submachinegun - in his basement and declared that it was exempt because it nor the materials used to make it ever crossed state lines. If I recall, the case was summarily dismissed after a decision in Raich, which was a similar situation, but with marijuana. Raich, in turn, built on Wickard v. Filburn, which makes my head hurt.

In Wickard, the court ruled that a commodity produced (grain) wholly inside a state, for personal consumption, could be regulated as interstate commerce because if it had not been produced, the consumer would have purchased it in interstate commerce. Raich takes the leap to say that this also applies when the interstate commerce of the product is illegal, as is the case with marijuana.

From a firearm's advocacy POV, this whole thing revolves around clearing out federal restrictions on firearms, such as the National Firearms Act of 1934. We are making progress in this arena today via direct challenge, though - first with DC v Heller, which affirmed the Second Amendment as an individual right, and now in McDonald v. Chicago, where we are seeking incorporation of this right against the states, either under the "privileges and immunities" clause or the "due process" clause of the 14th Amendment. It looks like we're going to get it under "due process", but be denied under "P&I".

Re:No Surgery Required?

[TheNarrator]

Unpatentable but useful procedures are a big hole in FDA policy, and I think the whitehouse should fund the HIH to get approvals for such procedures.

EXACTLY! If there is a medical procedure or drug that one must spend millions to prove is effective, and it can't be patented, it will never be developed no matter how well it works. That's because its use without approval will be illegal and it will cost millions just to give it away. This is the biggest problem in all of medicine and why we have DSHEA and other regulations.

Lawyer worries

[A nonymous Coward]

1. People need enough good info to make an informed decision, as the previous poster says.

2. Lawyers are going to get in on the act. It doesn't matter what kind of agreement is signed. All the lawyer has to do is show some lack of good information to win.

Aye, there's the rub. You have a bum leg at age 30, sign up, and ten years later it has to be amputated. Turns out there was some vague info out there ten years ago that under certain rare circumstances involving patients with red hair who ate more candied apples than most, the infusion turned cancerous. You have black hair and eat lots of sundaes with caramel, and claim you should have been told of the possible link to too much sugar.

It's no good arguing about personal responsibility. Maybe the doctor should have dumped a hundred research articles in your lap. Maybe you would have said that's too much, just give me the essentials. The lawyers will step in and screw it up because the boundaries are so vague.

Re:Lawyer worries

[Idiomatick]

Off topic but related:
I believe cars could be driven by computer as well (hell they are racing at pikes peak..). But the legal load would fall on whom? The software devs? So it becomes a legal impossibility even if it would be safer. And hence isn't worked on that much.

Re:How great

[MMC Monster]

Don't forget the power of the randomized double (or triple) blind trial.

Re:No Surgery Required?

[Chris Burke]

This is probably not patentable, and therefor no one will do the necessary trials to get it approved.

I thought that was the argument for why nobody would ever develop a non-patentable treatment in the first place. And yet, here it is. I doubt we got to the point of an actual stem cell therapy without expending lots of money on the research.

FDA approval costs a lot of money, it's true. Valid scientific clinical trials cost a lot of money even if you aren't trying to get approval, it's true. Maybe NIH funding the trials themselves for cases where industry won't is the answer.

Whatever the solution to this conundrum is, it isn't to forgo the clinical trials.

Re:Guns and weed, too. How big is this trend?

[Al Dimond]

Whatever the merits of the legal argument, I can only chuckle at what sort of clients this LAW FIRM is trying to attract by suggesting that Montana is likely to secede from the US on a public document on his web site.

Message from a stem cell advocate

[BarbaraH]

I'm pretty surprised at some of the naive comments on here. Many seem to be completely in the dark about the differences in stem cells and stem cell therapies. Several years ago, there were few visionary doctors and scientists out there willing to stick their necks out. Fortunately, for those of us with serious chronic and terminal diseases, there may be a renewed campaign to allow us to opt for stem cell therapy if we wish. So much research nowadays is to me, nothing but a jobs program or a way for a university to get more money through grants. It has to stop.The FDA has ties to Big Pharma and everyone knows that. The safety cry is getting old when the public is well aware of the Vioxx and now the Avandia boondoggles by the FDA. They are short on funds they claim. I suspect they are also short on science and too influenced by drug companies to be effective any more. It is time to clean house. Other countries are surpassing the U.S. in stem cell clinicals and treatment clinics. We not only lose economically, but we lose as far as being a country that is visionary and caring about its citizens, be they well or sick. I have never seen so many armchair critics who don't give a hoot about those of us that are very ill who believe that stem cell therapy may halt the progression of our disease and heal and regenerate. Dr. Centeno is a respected doctor. I live in Colorado. We are proud of him. I also am co-founder of the Stem Cell Pioneers. This is a patient moderated forum. Dr. Centeno has devoted a great deal of his time to ICMS, an organization that advocates safe stem cell therapy with guidelines and a patient registry that member doctors must agree to. Instead of spending valuable time conjecturing or bashing or keeping your head in the sand, I would invite you to join ICMS and get active. Millions of people are dying in this country. The medications I can get, no longer help with my disease. I have gone offshore to have stem cell therapy and it has saved my life. Others are not able to physically travel to offshore clinics. We need to be able to make the decision to have autologous stem cell therapy with our doctors, not a regulatory agency. Prior to my becoming ill, I probably would not have realized the magnitude of the problem that chronically and terminally ill patients face in this country. To deny us treatment or use scare tactics to convince us we are likely going to get cancer or something else quite dreadful from stem cell therapy is ridiculous. No, the long term (20-30 years down the road) is not known, but if stem cell therapy can reverse my disease that is 20-30 years I would never have in the first place. I'll take my chances thank you. Read the ICMS guidelines for safe stem cell treatment. I think you would agree that this is something that makes far more sense than hit and miss clinical trials that involve billions of dollars and many long years to be completed. Fertility clinics have been operating for years with such guidelines. Why the double standard? I think we all know the answer to that.

Re:No Surgery Required?

[pwfffff]

It has to do with the way they copy your stem cells, I believe. Every copy raises the risk of an error in the DNA being made into a new stem cell. I don't know how it would increase the cancer rate more than if you just waited for the stem cells to grow on their own, but that's the argument I've heard.

Re:No Surgery Required?

[pwfffff]

usage Although transitive sense 2 of flaunt undoubtedly arose from confusion with flout, the contexts in which it appears cannot be called substandard . If you use it, however, you should be aware that many people will consider it a mistake.

Re:No Surgery Required?

[LrdDimwit]

They also wax poetic about how awesome it is to be accountable to no one, and specifically gloat over not answering to the FDA. Now, IANAL, but I doubt their claim will stand up in court if/when the FDA says "Oh, really? We'll see about that." But leave that aside for a minute.

Why would being answerable to no one ever be a positive thing? Especially in the medical field! The entire reason the FDA exists is because people were selling sugar water for $30 a bottle and claiming it would cure any disease. Or worse, they would sell a folk remedy that turned out - once rigorous testing was done - to be poisonous. Anyone remember Vioxx? Or Fen-phen? History is replete with dozens of examples of serious complications like this.

Look at asbestos for example: it took decades of painstaking research to uncover the connection between asbestos and the diseases that are caused by exposure to it over very long periods of time, and not right away. But now? It's so hazardous entire specialized industries exist that serve no purpose but to know how to safely clean up asbestos-contaminated sites.

Similarly we have no idea what this therapy's non-obvious long term implications are. None. There is no way of knowing whether this treatment is going to lead to uncontrolled cell growth (that is, cause cancer) or somehow cause an auto-immune disease. Sure, using the patient's own cells makes this unlikely, but introducing bone marrow cells where they're not normally found might confuse the immune system. The FDA approval process is designed to mitigate these risks, and ensure that the procedure actually does what they say it does. Openly bragging about circumventing the FDA makes you a quack automatically, for that alone.

Re:No Surgery Required?

[Miamicanes]

> The BigPharma are already trying (and succeeding) in getting patents for stuff that we ALL already possess,
> and seek to make a profit from those patents.

Er, we all possess blood, and people give it up for free. Nevertheless, there are thousands of patents related to its collection, screening, processing, storage, and injection. "Big Pharma" isn't robbing the human race by "patenting stem cells", the companies are patenting the commercial processing of stem cells, and the equipment and chemicals used to do it. If your doctor wants to collect your stem cells and inject them elsewhere in your body, there's not a thing any IP lawyer can do to stop him... but they most certainly CAN do their best to prevent him from buying medical equipment (say, China) that infringes on one or more American patents.

Contrary to popular misconception, the FDA has NO role in the enforcement of IP law. If you seek approval for a drug protected by one or more patents, the FDA will go right ahead and process the application just like any other. If it's equivalent to a brand-name drug and you've documented everything properly, they'll approve it without so much as a grunt. The FDA doesn't HAVE to care about IP law, because they know that long before you sell your first tablet to a pharmacy, the patented drug's owners will have an injunction against you if they think there's the slightest chance their lawyers might be able to convince a judge (and possibly a jury) that your drug infringes against their patent.

Re:No Surgery Required?

[Metasquares]

The process of inducing the cells to replicate may cause mutations, and some cells also undergo pre-malignant changes when exposed to an environment they weren't meant for. Stem cells may be exempt from this second issue, as they're not really "meant for" anything yet: they have yet to differentiate. What would be considered a metaplastic change in another cell would be perfectly normal for a stem cell.

Re:No Surgery Required?

[kimvette]

Stem cells are still in the experimental stage on humans, hence this doctor's flaunting of FDA regs

Is it any more risky than having vertebrate fused, or having teflon discs inserted in the place of natural cartilage?

Re:No Surgery Required?

[kimvette]

Anyone remember Vioxx [usatoday.com]? Or Fen-phen [wikipedia.org]?

. . . both approved by the FDA.

Re:No Surgery Required?

[jnork]

If it's injected via a needle, it must be a drug.

Expect to see salt water on the controlled substances list soon.

No more suffering

[lukasevenn]

It is really like a miracle for the patients. Now there will be no more misery in this world. http://www.articlesbase.com/health-articles/colopure-cleanse-review-faster-weight-loss-supplement-1961267.html

Re:Yes, it is.

[CyberZen]

The most common gastric bypass surgery (the RnY type) actually has two modes of action: a restrictive component, which you address, and a malabsorptive component. That is, not only is the size of the gastric pouch restricted, but a section of the small intestine is completely bypassed.

Operations which restrict intake only (like gastric banding, for example) are not as effective. It has also been observed that the intestinal bypass impacts incretin response, and has other metabolic effects.

I won't deny that we, as a people, eat way too much. But more and more research is showing that this _might_ be more complicated than calories in, calories out.

Re:No Surgery Required?

[repapetilto]

While I don't know the exact procedure (only scanned the article)... In general you would fear cancer because the cells are being extracted then cultured in a flask and being stimulated to divide (using growth factors present in your own blood platelets I'm assuming) moreso than usual. Since theres something like 3-300 errors everytime a cell divides (but compare that to the 3 billion nucleotides in each of your cells, and that most of the mutations won't lead to cancer and its not that big a deal), the logic is that the more times a cell divides the more likely a set of mutations can happen that makes a cell start doing its own thing which is grow whether the other cells around it tell it not to (cancer). Within the body you also have immune cells surveying everything making sure cells arent expressing mutant proteins or in the wrong place and killing them off before they become an issue. This isnt occuring in the flask. Also the cells in the flask may be more exposed to whatever UV radiation or chemicals are around thus increasing the mutation rate. Disclaimer: thats just off the top of my head. I don't know very much about stem cell culturing in particular, its just what I would expect to happen.

language

[binarybum]

"and we should all hope that more companies will begin offering this procedure in other states soon." ..and we should all be weary of this kind of language.

and we should all drink the kool-aid.

Re:How great

[jamie(really)]

Except the FDA's job is to make sure that big pharma can maintain its patents. If any doctor can just cure you, where will Athersys and their "stem cell derived drug", be? Hell no. You will get your cure from a properly paid up lobbying company, not a couple of geniuses who have the nerve to avoid indentured service and signing away their ideas.

Re:How great

[clarkkent09]

I understand the issue but still as somebody who considers the freedom of individuals to do whatever the hell they like with their own body in the same league as the freedom of speech, I don't see what gives the government any right to make this kind of decisions for them. Regulate the labeling all you like, make them print the fact that the risks are unknown in big bold letters etc. Still, the final decision should be with the patient. In the cases where there is not approved treatment and the patient is certainly going to die anyway, denying them untested treatments is criminal.

Re:No Surgery Required?

[ultranova]

I'm kind of surprised that big pharma arn't getting into the whole stem cell thing.

It's not really all that surprising. Stem cells need to be extracted from the patient himself, then re-implanted; in other words, it's a surgical procedure, not medicine. It could be performed by a doctor with a one-time operation, rather than having the patient keep paying for medicinal treatment for the rest of his life.

It's starting to sound more and more like a miracle cure for everything from paralysis to acne.

And if it really is, once the patent runs out, how will the big bad pharma keep on selling nonworking cures for these conditions?

About time . . .

[Alan R Light]

. . . about damn time.

Banned in 5... 4... 3...

[WoollyMittens]

I'm pretty sure our patriarchy will decide against the practice of miracle cures. After all... only Jesus was supposed to do this stuff.

Cost:Benefit analysis

[crmarvin42]

For me, the issue is quality vs quantity. Avoiding cancer will increase the quantity of your life (+years), but if you have debilitating injuries that severely limit your motion then you'll probably have a dreased quality of life for the years you have left to you. In the example of knee injuries, they can make you just this side of crippled. The obligatory sedentary life that results brings with it a host of other health concerns so that the increased risk of cancer might be offset by the reduced risk of say, cardiovascular disease.

I think that this clinic is playing russian roulette with the FDA, but I hope these therapies aren't rejected out of hand because of the potential for increased cancer. Cancer will get you eventually assuming nothing else kills you. The sooner we find cures/treatments for all other illnesses, the sooner we can divert all biomedical research into curing cancer. (Yes I realize it's a pipe dream)

Re:FDA is a joke

[powerrc]

I completely understand what you are saying and I seriously considered taking my 5 year old son to Germany to have stem cell treatment - he has dilated cardiomyopathy and may need a heart transplant at some point - I was and still am desperate. So what has stopped me? Well a few reasons really. But ultimately this - Stem cells are ultimate cells that can turn into any other kind of cells - but what if they caught onto bad cells, abnormal cells could they start to generate more of those cells? And we all know what abnormal growths can be. The problem is we can't inject the cells and say "in you go boys" then say "out you come boys you have done your job now" how do we switch them off? so until they have had thorough adult stem cells trials on humans, and they are happening over here in the UK – so we are on our way, then we can't be convinced that we won't just be making matters worse by having them injected – we could be creating more problems. I feel I need to wait as long as I can before I consider going ahead with stem cells for John. We have had to make life and death decisions for John and I never ever forgive myself if I decided to opt for stem cells and as a result he got cancer in doing so and this is a real possibility.

Re:No Surgery Required?

[yabos]

The FDA is a friggin joke. They've been caught numerous times falsifying data and approve drugs that later turn out to kill people. This is because the FDA does not actually do a full examination of each new drug. They just rubber stamp a lot of drugs based on what the pharmaceutical companies tell them.

I wouldn't be surprised if we hear that the FDA is going after this company within the next month or so, even if they think they have gotten around the rules.

Re:No Surgery Required?

[yabos]

The FDA states, anything that is used to treat a disease or condition is a drug. If you were to try selling vitamin C to treat scurvy, congratulations, you can be attacked by the FDA for selling an unapproved drug. That is no joke btw. This is exactly why every supplement you buy says "this product is not intended to treat, or cure any disease and is not approved by the FDA"

Re:No Surgery Required?

[profplump]

You realize that both Vioxx and Fen-phen were approved by the FDA, right? And that asbestos is a naturally-occuring, ubiquitous fiber that is not dangerous unless you're exposed to high levels or for an extended period? And that there are many installations of asbestos that are not being removed because they pose no significant danger as installed?

Re:No Surgery Required?

[MistrBlank]

You insensitive clod, some stem cell treatments are used to treat cancer:

http://www.cancercenter.com/stem-cell/stem-cell-allogeneic.cfm

Mmmmmm

[pugugly]

This theory of the FDA's scope smells way too much like the theory of anti-tax nuts that claim Ohio is not a state (Or my favorite version, an anti-tax nut that claimed a paragraph noting the IRS jurisdiction "including U.S. Territories" limited the IRS to those territories.)

I want stem cell research, but this is a bad idea.

Pug

Cool, but why so long if no side effects

[hesaigo999ca]

I wonder if this really is just about the supposed moral issue that goes along with cell cloning, or if just being the tissue is being created as needed and not as a whole human being cut up, can it still fall under the moral grounds issue of not being acceptable?
Has anyone bothered to show the politicians this point, and how absurd this is now because you can clone cells and then help regenerate tissue, nerves and what not, without cloning the whole individual or even the whole body part...?