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Doctors Skirt FDA To Heal Patients With Stem Cells 394

Posted by kdawson
from the self-supplied dept.
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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Doctors Skirt FDA To Heal Patients With Stem Cells

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  • I imagine both sexes have something to look forward to from this exciting development in the self improvement industry.
    • Misleading Summary (Score:2, Insightful)

      by sycodon (149926)

      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: (Score:3, Funny)

        by Anonymous Coward

        What is this? A late night infomercial?

        No, those have editors.

      • Re: (Score:3, Informative)

        by kkleiner (1468647)
        Good point. Should have been "allowing many patients to easily walk or run who have had difficulty doing so for years
    • by mcgrew (92797) * on Tuesday March 09, 2010 @03:51PM (#31417994) Homepage Journal

      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.

  • cancer worries (Score:5, Interesting)

    by drDugan (219551) * on Tuesday March 09, 2010 @03:02PM (#31417332) Homepage

    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 (Score:5, Insightful)

      by ColdWetDog (752185) on Tuesday March 09, 2010 @03:07PM (#31417406) Homepage
      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.

      • by Yvan256 (722131) on Tuesday March 09, 2010 @03:19PM (#31417580) Homepage Journal

        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: (Score:3, Insightful)

        by Hadlock (143607)

        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 (Score:4, Insightful)

          by Idiomatick (976696) on Tuesday March 09, 2010 @03:33PM (#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 (Score:4, Informative)

            by ColdWetDog (752185) on Tuesday March 09, 2010 @03:50PM (#31417982) Homepage
            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 [quackwatch.org].
          • Re: (Score:3, Insightful)

            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 liberta
        • Re: (Score:3, Insightful)

          by vlm (69642)

          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 (Score:4, Interesting)

            by Hadlock (143607) on Tuesday March 09, 2010 @05:46PM (#31419668) Homepage Journal

            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: (Score:3, Insightful)

            by Chris Burke (6130)

            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

        • Re:cancer worries (Score:5, Insightful)

          by natehoy (1608657) on Tuesday March 09, 2010 @04:01PM (#31418176) Journal

          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.

      • 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 (Score:5, Interesting)

        by Anonymous Coward on Tuesday March 09, 2010 @05:35PM (#31419526)

        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: (Score:3, Interesting)

      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 rat
      • by BobMcD (601576)

        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 (Score:5, Insightful)

        by Khyber (864651) <techkitsune@gmail.com> on Tuesday March 09, 2010 @04:06PM (#31418252) Homepage Journal

        "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 (Score:4, Informative)

          by geekoid (135745) <dadinportland@ya ... m minus math_god> on Tuesday March 09, 2010 @06:07PM (#31419942) Homepage Journal

          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.

    • by DesScorp (410532)

      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 (Score:5, Insightful)

      by Princeofcups (150855) <john@princeofcups.com> on Tuesday March 09, 2010 @03:26PM (#31417666) Homepage

      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 (Score:5, Interesting)

      by natehoy (1608657) on Tuesday March 09, 2010 @03:28PM (#31417686) Journal

      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: (Score:3, Informative)

        by MozeeToby (1163751)

        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.

      • by gangien (151940)

        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).

      • by vlm (69642)

        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 accelera

    • by physburn (1095481)
      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 transp
    • by Tacvek (948259)

      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 mut

  • Not surprising (Score:3, Insightful)

    by MBCook (132727) <foobarsoft@foobarsoft.com> on Tuesday March 09, 2010 @03:03PM (#31417348) Homepage

    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 (Score:4, Insightful)

      by Bill, Shooter of Bul (629286) on Tuesday March 09, 2010 @03:09PM (#31417428) Journal
      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.
      • by timeOday (582209)
        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.

      • by MBCook (132727)

        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: (Score:3, Insightful)

          by ArcherB (796902)

          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 fede

          • Re:Not surprising (Score:4, Informative)

            by MojoRilla (591502) on Tuesday March 09, 2010 @06:13PM (#31419984)
            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 [slate.com] 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 (Score:5, Interesting)

        by natehoy (1608657) on Tuesday March 09, 2010 @03:37PM (#31417818) Journal

        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 (Score:5, Interesting)

      by fusiongyro (55524) <faxfreemosquito.yahoo@com> on Tuesday March 09, 2010 @03:14PM (#31417514) Homepage

      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: (Score:3, Insightful)

        by MBCook (132727)

        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 t

        • 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
        • by LanMan04 (790429)

          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 (Score:4, Insightful)

        by WrongMonkey (1027334) on Tuesday March 09, 2010 @03:34PM (#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 (Score:5, Insightful)

          by fredjh (1602699) on Tuesday March 09, 2010 @03:54PM (#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 (Score:5, Informative)

        by yog (19073) * on Tuesday March 09, 2010 @03:44PM (#31417898) Homepage Journal

        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.

      • by Hatta (162192)

        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.

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

      • Re:Not surprising (Score:5, Insightful)

        by rattaroaz (1491445) on Tuesday March 09, 2010 @04:13PM (#31418348)

        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.

  • by oldhack (1037484) on Tuesday March 09, 2010 @03:09PM (#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.

  • by losfromla (1294594) on Tuesday March 09, 2010 @03:12PM (#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: (Score:3, Informative)

      by TubeSteak (669689)

      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."

      • 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 (Score:2, Insightful)

    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: (Score:2, Insightful)

      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.

    • by MrMista_B (891430)

      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?

    • 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.

  • Medical treatment that skirts federal regulations? Sounds like a lawyer's wet dream. Stem cell treatment has great potential, but they better tread carefully.
    • by fredjh (1602699)

      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.

  • A Real Cowboy (Score:5, Insightful)

    by BJ_Covert_Action (1499847) on Tuesday March 09, 2010 @03:17PM (#31417558) Homepage Journal
    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.
  • by 00Sovereign (106393) on Tuesday March 09, 2010 @03:17PM (#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.
    • by droopycom (470921)

      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...

    • by jbeaupre (752124) on Tuesday March 09, 2010 @04:10PM (#31418304)

      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)

  • by BenEnglishAtHome (449670) on Tuesday March 09, 2010 @03:18PM (#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: (Score:3, Informative)

      by schon (31600)

      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: (Score:3, Interesting)

        by corbettw (214229)

        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.

  • Good luck with that (Score:5, Informative)

    by Hatta (162192) on Tuesday March 09, 2010 @03:29PM (#31417692) Journal

    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.

    • Bad Logic (Score:3, Informative)

      by Prien715 (251944)

      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.

  • Countdown... (Score:3, Insightful)

    by kenp2002 (545495) on Tuesday March 09, 2010 @03:32PM (#31417750) Homepage Journal

    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...

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