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Doctors Skirt FDA To Heal Patients With Stem Cells

kdawson posted more than 4 years ago | from the self-supplied dept.

Biotech 394

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."

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394 comments

Implants are a thing of the past? (2, Insightful)

losfromla (1294594) | more than 4 years ago | (#31417312)

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

Misleading Summary (2, Insightful)

sycodon (149926) | more than 4 years ago | (#31417604)

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 (3, Funny)

Anonymous Coward | more than 4 years ago | (#31417652)

What is this? A late night infomercial?

No, those have editors.

Re:Misleading Summary (2, Informative)

kkleiner (1468647) | more than 4 years ago | (#31417708)

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

Re:Implants are a thing of the past? (1, Interesting)

repka (1102731) | more than 4 years ago | (#31417672)

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

Re:Implants are a thing of the past? (1)

Golddess (1361003) | more than 4 years ago | (#31417972)

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? (4, Funny)

mcgrew (92797) | more than 4 years ago | (#31417994)

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.

No Surgery Required? (0, Offtopic)

spun (1352) | more than 4 years ago | (#31417328)

Does that mean we just crack open the fetuses and suck out the stem cells? [southparkstudios.com]

Re:No Surgery Required? (5, Insightful)

natehoy (1608657) | more than 4 years ago | (#31417442)

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.

Re:No Surgery Required? (4, Interesting)

fahrbot-bot (874524) | more than 4 years ago | (#31417596)

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:No Surgery Required? (1)

Aeros (668253) | more than 4 years ago | (#31417702)

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:No Surgery Required? (2, Insightful)

natehoy (1608657) | more than 4 years ago | (#31417872)

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:No Surgery Required? (1)

Aeros (668253) | more than 4 years ago | (#31417934)

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.

cancer worries (5, Interesting)

drDugan (219551) | more than 4 years ago | (#31417332)

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 (5, Insightful)

ColdWetDog (752185) | more than 4 years ago | (#31417406)

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 (4, Funny)

Yvan256 (722131) | more than 4 years ago | (#31417580)

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 (2, Insightful)

Hadlock (143607) | more than 4 years ago | (#31417678)

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 (3, Insightful)

Idiomatick (976696) | more than 4 years ago | (#31417770)

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 (2, Insightful)

vlm (69642) | more than 4 years ago | (#31418010)

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 (1)

Idiomatick (976696) | more than 4 years ago | (#31417874)

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 (0)

Anonymous Coward | more than 4 years ago | (#31418168)

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

In these cases I always side with the safe "snake oil quack" and i'm never particularly. Funny how that works, as much as I dislike the FDA, the people who skirt it for "magical" reasons are so much worse...

Re:cancer worries (0)

Cazakatari (1403081) | more than 4 years ago | (#31417448)

That is one reason it has been so difficult to be officially approved, but now that it is at least starting, this information will begin to come out. New procedures always involve risk. It is unfortunate when 1 in a 1000 treatments kill or adversely affect a patient, but if you want to walk again and are faced with those odds, I think the choice is clear.

Regardless, these kinds of procedures are routine or nearly so already in other animals, I see no reason why it would be much different in people.

Like my old man on testosterone (0)

Anonymous Coward | more than 4 years ago | (#31417488)

Me and his urologist know that his PSA rises on the stuff and we think we may be stirring up a hornets nest in his prostate, but on balance, the anaerobic effects, higher blood counts, and cognitive effects outweigh the downside of giving an 81-year-old, a potentially few less years.

Even if stem cell treatment was demonstratively resulting in increased cancer risk, a whole class of older patients could still benefit.

Dad's double-knee replacement surgery took a lot out of him. If we could resurface his knees with a treatment that might cause him cancer in his 90's, we would probably go for it.

 

Re:cancer worries (2, Interesting)

JustinOpinion (1246824) | more than 4 years ago | (#31417626)

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 [benthamdirect.org] . 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 (1)

BobMcD (601576) | more than 4 years ago | (#31418042)

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 (1)

DesScorp (410532) | more than 4 years ago | (#31417644)

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 (5, Insightful)

Princeofcups (150855) | more than 4 years ago | (#31417666)

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 (1)

Aeros (668253) | more than 4 years ago | (#31417774)

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 (4, Interesting)

natehoy (1608657) | more than 4 years ago | (#31417686)

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 (2, Informative)

MozeeToby (1163751) | more than 4 years ago | (#31418078)

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 (1)

gangien (151940) | more than 4 years ago | (#31418104)

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 (1)

physburn (1095481) | more than 4 years ago | (#31417742)

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 [feeddistiller.com] Feed @ Feed Distiller [feeddistiller.com]

Re:cancer worries (0)

Anonymous Coward | more than 4 years ago | (#31417878)

If we, as a species, proceeded at speeds stymied by 100% safety measures, most of the human race would be dead by now.

That this procedure is any more dangerous than the questionable long term food we eat, water we drink, or air we breathe, remains to be seen. It's risky breakthrough's like this, that give me just a little hope that the entire medical industry isn't completely fucked. Frankly, having some bone marrow extracted, processed, then shot into my knee sounds a hell of a lot easier than a full on synthetic knee replacement that I'm looking at in about 10-15 years.

Re:cancer worries (0)

Anonymous Coward | more than 4 years ago | (#31417936)

Mmm. Delicious, delicious tumors.

How great (0)

vikingpower (768921) | more than 4 years ago | (#31417342)

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

Re:How great (4, Informative)

Red Flayer (890720) | more than 4 years ago | (#31417506)

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.

Re:How great (3, Interesting)

Red Flayer (890720) | more than 4 years ago | (#31417592)

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 [state.co.us] .

Re:How great (5, Interesting)

clarkkent09 (1104833) | more than 4 years ago | (#31417704)

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.

Re:How great (2, Insightful)

wizardforce (1005805) | more than 4 years ago | (#31418026)

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 (1)

TooMuchToDo (882796) | more than 4 years ago | (#31418100)

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 (5, Informative)

Mirlas (760973) | more than 4 years ago | (#31418102)

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 (0)

Anonymous Coward | more than 4 years ago | (#31417812)

If I understand the article correctly, they are right in saying that the FDA does not apply to them.

The FDA only regulates the *manufacturers* of medical devices, drugs, etc... They do not regulate doctors. Doctors can do whatever they want, but if they stray too far from the standard of care and end up causing harm to a patient, they are opening themselves up to be sued and losing their license and other crap that has nothing to do with the FDA.

Since they are not a manufacturer, but rather a private practice who has come up with this method of treatment on their own, I don't think the FDA applies.

Re:How great (1)

Red Flayer (890720) | more than 4 years ago | (#31418030)

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.

Daring? Really? (5, Informative)

DesScorp (410532) | more than 4 years ago | (#31417832)

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 [wikipedia.org] 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.

Not surprising (3, Insightful)

MBCook (132727) | more than 4 years ago | (#31417348)

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 (3, Insightful)

Bill, Shooter of Bul (629286) | more than 4 years ago | (#31417428)

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 (1)

timeOday (582209) | more than 4 years ago | (#31417656)

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 (1)

MBCook (132727) | more than 4 years ago | (#31417688)

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 (5, Interesting)

natehoy (1608657) | more than 4 years ago | (#31417818)

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 (5, Interesting)

fusiongyro (55524) | more than 4 years ago | (#31417514)

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. [wikipedia.org] 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 (2, Insightful)

MBCook (132727) | more than 4 years ago | (#31417670)

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.

fetal stem cell use & research not illegal (1)

SethJohnson (112166) | more than 4 years ago | (#31417984)

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 [nih.gov] . 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

Re:Not surprising (0, Troll)

Hatta (162192) | more than 4 years ago | (#31418052)

I'm aware of all that, and I still think that fetal stem cells shouldn't be used.

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

Re:Not surprising (3, Insightful)

WrongMonkey (1027334) | more than 4 years ago | (#31417786)

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 (1)

maxume (22995) | more than 4 years ago | (#31417822)

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 (4, Insightful)

fredjh (1602699) | more than 4 years ago | (#31418050)

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 (5, Informative)

yog (19073) | more than 4 years ago | (#31417898)

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 (1)

Hatta (162192) | more than 4 years ago | (#31418006)

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.

Baby Eating Advocacy (1)

srobert (4099) | more than 4 years ago | (#31418014)

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

Re:Not surprising (1)

maxume (22995) | more than 4 years ago | (#31417724)

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 (1)

badboy_tw2002 (524611) | more than 4 years ago | (#31417930)

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.

Political Landscape (1)

MortimerGraves (828374) | more than 4 years ago | (#31417950)

> 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".

Re:Not surprising (0, Troll)

Citizen of Earth (569446) | more than 4 years ago | (#31418028)

When you start getting these kind of great results, the moral argument gets harder.

You mean like "God wants you to stay a cripple." Gee, God, why did you invent stem cells?

It's a shame... (-1, Troll)

Anonymous Coward | more than 4 years ago | (#31417358)

That medical breakthroughs in this field had to be restrained for almost a decade. What did that do to help anybody?

 

 
 

 

 

 
 

 

 

 
 

 

Re:It's a shame... (0)

Anonymous Coward | more than 4 years ago | (#31417388)

But..but.. it meant that all those precious fetuses that would have been otherwise thrown into the incinerator weren't "killed" in order to harvest stem cells! Think of the unborn children!!

Re:It's a shame... (4, Informative)

natehoy (1608657) | more than 4 years ago | (#31417838)

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.

Slashdot Shopping Network (4, Funny)

oldhack (1037484) | more than 4 years ago | (#31417430)

"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.

Implant some grammar cells (0)

Anonymous Coward | more than 4 years ago | (#31417440)

FTFA: "How can Centeno and Schultz flaunt the lack of federal approval?"

Personally I'd flaunt it in the trade press!

Geez (0, Offtopic)

JumpDrive (1437895) | more than 4 years ago | (#31417456)

The next news story is a large group of people in Colorado are uncontrollably chasing cars. Didn't these stem cell researchers learn anything from Toyota?

alternative treatment (3, Insightful)

losfromla (1294594) | more than 4 years ago | (#31417476)

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 (2, Informative)

TubeSteak (669689) | more than 4 years ago | (#31417710)

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 [benthamdirect.org] and the Article [benthamdirect.org] (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 (1)

losfromla (1294594) | more than 4 years ago | (#31417916)

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 (1)

MightyMartian (840721) | more than 4 years ago | (#31418038)

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.

Ends & Means (2, Insightful)

hardwarejunkie9 (878942) | more than 4 years ago | (#31417518)

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 (1, Insightful)

Lunix Nutcase (1092239) | more than 4 years ago | (#31417578)

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 (0, Troll)

tthomas48 (180798) | more than 4 years ago | (#31417738)

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

Actually it's the same logic that could lead to the outlawing of masturbation, menstruation and miscarriages. People tend to gloss over the "implanting in the uterine wall" as the moment of conception, when that's really a much more key element than fertilization.

The slavery analogy doesn't really hold. Other than the fact that in your world slave owners could sue for the rights to the stored embryos. I think. I find you comparison somewhat confusing.

Re:Ends & Means (1)

MrMista_B (891430) | more than 4 years ago | (#31417752)

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 (1)

TooMuchToDo (882796) | more than 4 years ago | (#31418136)

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.

Patients aren't the only ones excited (1)

T Murphy (1054674) | more than 4 years ago | (#31417526)

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 (1)

fredjh (1602699) | more than 4 years ago | (#31417608)

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 (0)

Anonymous Coward | more than 4 years ago | (#31417868)

The FDA really can't win.

FDA doesn't approve miracle new procedure : BOOO! The FDA are getting in the way of progress.
FDA approves new miracle procedure, then 10 year later everyone has cancer : BOOO! Fire the head of the FDA, we want heads to roll, why didn't they think of the children.

Determining whether or not a new medical procedure is safe is hardly an overnight job, let alone ones that include the use of stem cells. The problem is people are too bloody impatient.

A Real Cowboy (5, Insightful)

BJ_Covert_Action (1499847) | more than 4 years ago | (#31417558)

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.

Not to be the bad guy but... (5, Insightful)

00Sovereign (106393) | more than 4 years ago | (#31417562)

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... (1)

droopycom (470921) | more than 4 years ago | (#31418170)

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...

Guns and weed, too. How big is this trend? (2, Interesting)

BenEnglishAtHome (449670) | more than 4 years ago | (#31417564)

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 [panamalaw.org] 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:Guns and weed, too. How big is this trend? (2, Informative)

schon (31600) | more than 4 years ago | (#31417920)

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 [wikipedia.org] , 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:Guns and weed, too. How big is this trend? (0)

Anonymous Coward | more than 4 years ago | (#31418036)

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 [wikipedia.org] , 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.

And the other part is that nobody else does this.

gov't (0)

Anonymous Coward | more than 4 years ago | (#31417654)

FTA
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.

Boo! There are lot of people on this planet... it's time to let the willing take risks in the name of advancing science and medicine instead of throwing up procedural and monetary barriers.

Good luck with that (4, Informative)

Hatta (162192) | more than 4 years ago | (#31417692)

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 [wikipedia.org] 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.

Countdown... (2, Insightful)

kenp2002 (545495) | more than 4 years ago | (#31417750)

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...

Re:Countdown... (0)

Anonymous Coward | more than 4 years ago | (#31418008)

That's very funny. Dr. Centeno is a frequent speaker at the Colorado Trial Lawyer's Association conventions.

Americans skirted the FDA for years, via Mexico (1)

snadrus (930168) | more than 4 years ago | (#31417792)

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.

ABOMINATION! (0)

Anonymous Coward | more than 4 years ago | (#31417850)

This is an abomination! God will surely strike down (either in this life or the next) those who would be Him. SHAME on them.

FDA is a joke (0)

Anonymous Coward | more than 4 years ago | (#31417888)

There are so many things that people put in their body that the FDA refuses to regulate.

What job is it of the FDA to decide how I want to use my own body's stem cells within my own body. I will put them where I please.

So, the way to improve health care (0)

Anonymous Coward | more than 4 years ago | (#31418088)

So, the way to improve health care is to _bypass_ the Federal Government. Somebody should tell Obama!

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