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

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

[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

[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

[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

[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

[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

[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

[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

[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

[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

[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.

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

[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

[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

[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

[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

[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.

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: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.

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

[idontgno]

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

See also "loose cannon".

Re:A Real Cowboy

[fuzzyfuzzyfungus]

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

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...

[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: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.

Re:Misleading Summary

[Anonymous Coward]

What is this? A late night infomercial?

No, those have editors.

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: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.

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: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: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: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

[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.

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: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.

Re:Misleading Summary

[longhairedgnome]

The FDA doesn't control drugs worldwide

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.