Have we crossed the tipping point to stem cell disaster?

Earlier this year, Dr “LookGood” aka Dr. Steven Victor, cosmetic surgeon to the stars, received a warning letter from the FDA over how his clinic was handling stem cell-related procedures. The FDA listed 16 issues as problems.

On April 20, Dr. Thomas E. Young of Young Medical Spa in Pennsylvania also received an FDA warning letter. You can read it here. The FDA cited 14 specific failures by Young Medical Spa that need to be addressed.

I expect we’ll see a growing stream of FDA warning letters to purveyors of stem cell cosmetics.

At some time soon, if we are not already there, however, we will reach a tipping point.

At that time, there will be so many dubious stem cell cosmetics and stem cell sports medicine clinics and other stem cell clinics out there, that the FDA  and state regulatory agencies will no longer be able to keep up with them. The situation will spiral out of control leading to an increasing number of deaths. For background see these important posts:  ‘From Boobs To Baldness‘ and ‘From Boobs to Baldness 2.0‘ and stem cell sports medicine.

What’s the solution?

I don’t know for sure, but we are close to this tipping point or perhaps even past it, and this poses serious risks to the health of Americans and to the stem cell field overall.

We are in trouble and people need to start talking about this.

35 Comments

  1. [email protected]
    May 3, 2012 at 10:36 am

    Yikes! Everyone head for the hills, stem cells are coming, stem cells are coming!
    The FDA is looking out for you so don’t pay any attention to stem cells unless they say they are safe. After all they know about stem cells, they can cause cancer, death, or worse the dreaded placebo effect. They know that ESCs work, because given the right environment, the womb, and enough time, 9 months, they form over 220 different cell types, better known as a baby. So they’ll allow clinical trials on that, but the rascally little autologous adult stem cells are very bad, they need to take that very slowly. Don’t come down from the hills until they tell you it’s safe.
    I agree we should clamp down on unproven claims, but pa lease don’t throw the 220 cell types out the window with the bath water. Autologous cells are not going to cause death, they will not cause the placebo effects, and they will not even cause cancer. People who are scientists will agree, it’s the most wonderful time in medicine since the antibiotic, perhaps even better. So here is my advice, if you have congestive heart failure, pay attention to the FDA, go home till they tell you it’s safe. If you are a career sports professional and you want another year in your chosen profession, just don’t be greedy, go home until they tell you it’s safe. If you have early signs of wet macular degeneration, go home till they tell you it’s safe. If you have pain in your joints and early signs of arthritis they know doctors that will cut out your old bone and replace it with titanium. Go home to they tell you it’s safe. After all they know best. Trust them, they are looking out for you.


    • Greg,
      Thanks for the creatively written comment.

      The reality is that this is a very serious situation.

      People have died from dubious stem cell treatments including children. As a stem cell scientist and someone who sees stem cells revolutionizing medicine in the future, I’m the last one to say anything like we should wait forever. I’m also a patient advocate so I know waiting indefinitely is not an option, but unsafe, dubious stem cell treatments being allowed to go unchecked and quite literally kill many people will surely in the end damage the stem cell field and ultimately kill innovation.


      • Paul, seriously. The tipping point? Kids have died FROM STEM CELLS? Does it even matter to you if the evidence supports your claims? Malcolm Gladwell’s metaphor is *just right* for your harangue about the FDA tipping point. How about we wait and see what the FDA actually FINDS when it does its careful examinations, and what the court says about FDA’s position on aMSCs in the Centeno case, and what comes out in the tidal wave of MSC literature on phase I/II trials and other clinical studies THIS year before you post another comment about the sky falling. It’s getting REALLY tiresome hearing about the horrifying[ly unsubstantiated] deaths that are occurring from aMSC use in humans from a guy working with embryonic stem cells, and it’s even more fun reading Sipp, who, sans PhD (or MA) in ethics, runs an ethics institute in an embryonic stem cell group, scream about the evil of ANYONE who believes that adult stem cell progress is absolutely overwhelmingly amazing and getting better. Nobody wants to see unregulated stem cell use. But if you want to get worked up about unregulated cell modification, how about talking about the kids whose long term outcomes are totally unknown, produced through the MAXIMUM modification of embryos in PGD, ICSI etc., none of which is regulated at all or has been through any trials in US FDA. This nonsense has gone far enough. People are dying? Put up or shut up.


        • Glenn,
          Thanks for your comment.
          I think adult stem cells are absolutely amazing so let’s get that clear and I believe that is something that you and I agree upon totally.
          I just favor an inclusive approach to the stem cell field that allows us try to develop all the tools we can to fight the greatest diversity of diseases for the greatest number of people.
          Regarding your comment, yes, in fact people have died from stem cell treatments including at least two kids abroad (in Germany and that Israeli boy). Here in the U.S. at least two deaths are linked to Dr. Grekos and I suspect there are a substantial number of additional stem cell deaths in the U.S. due to dubious clinics that to date simply remain unrealized. Certainly out of control doctors and pseudo-doctors injecting people helter-skelter with all kinds of “stem cells” substances ( e.g. placental extracts http://tinyurl.com/3bm8zts ) poses potentially deadly risks from infection and immune reactions (and possibly tumors) right here in the U.S. not to even get into what is going on around the world outside the U.S.
          So, yeah, the stakes are high and include people dying.
          Paul


          • But Paul the problem is that bad doctors practice bad medicine. This is a problem with practicing bad medicine, not with stem cells. If some guy with no license gets arrested for practicing medicine using stem cells without a license, duh, that is a problem. But it isn’t a problem with stem cells, it is the EXACT problem we have ten orders of magnitude more with inappropriate off label prescribing practices and so forth. To argue that these deaths are caused by stem cells, not by Grekos’ pal perforating somebody’s abdomen, or some X-Cell person sticking a needle in the brain stem, is like saying that deaths from traffic accidents prove that seat belts don’t work. I’d love to see the statistics that merit “adult stem cell exceptionalism” (whereby you can ignore the fact that autologous MSCs have not caused any deaths of which anyone is aware – certainly none that a forensics or peer-reviewed scientist writing in a journal has documented as being related to a stem cell). The problem in this debate is that stem cell exceptionalism has successfully persuaded otherwise rational people into terror that MSCs themselves are lethal.


            • I believe it must be teased apart. There are stem cells and then there are stem cells.
              “Stem cells” is akin to an advertising slogan for many clinics and doctors these days. Using the name stem cells (who knows what they are really injecting) to drum up business many doctors and clinics are injecting patients with “stuff”. What’s in there? I don’t know. Sometimes, yes, it is MSCs. Sometimes it simply adipose tissue. Sometimes it is PBS probably. Sometimes it may be dead cells. Whatever it is, they call it “stem cells” and market it that way. It’s out of control.

              Then there are places really using stem cells so I suppose that is some consolation, but not just limited to MSCs (although there is even debate over exactly what MSCs are and I’ve heard very exceptional scientists saying that each doctor’s “MSCs” are different). Are MSCs safer than undifferentiated ESCs? For sure. Are MSCs by definition safe? No.
              It’s not just actual death that is possible but many other problems.
              Based on some of these FDA warning letters, basic medical SOPs are not being followed including such things as labeling, documenting, sterilizing, etc. I can easily see how these could cause disasters. Hence the need for regulation.


            • I’d love to re-phrase you:
              “stem cell exceptionalism has successfully persuaded otherwise rational people into marketing that MSCs themselves are effective.”
              It works both ways LOL


              • Excellent point, Alexey!
                Glenn, how about proving that any given clinic’s “MSCs” are non-tumorigenic, non-immunogenic (as prepared in that clinic), etc?
                When we are talking about injecting things into people, the responsibility should be to prove safety not for concerned citizens to prove a lack of safety.


  2. @Glenn McGee
    There are many cases of death in hematology-oncology after autologous hematopoietic stem cell transplantation. In this case, physicians, can’t provide direct evidence that stem cells caused the death, but there are enough evidence that it is procedure-associated, conditioning (TBI-neutropenia)-associated and so on. I don’t think today anyone can prove that autologous “MSC” specifically caused a death. Mostly because we don’t have information about patient’s cases who had gone for “stem cell treatments offshore”.

    But on the other side of the plate,
    A few questions to you –
    1. Is there any evidence that auto- adult stem cells effective in any indication outside of hematopoietic cells for homologous use?
    2. Is there any evidence that stem cells injected into the patients exclusively cause therapeutic effect, but not their progeny (progenitor cells) or mature cell types?
    3. Is there any evidence that “cultured mesenchymal stem cell”, in fact stem cell?
    4. What can provide us (professionals) an evidence of efficacy of the “autologous stem cell treatment”? Controlled trials? Any trials? Publications only + conference reports? Physician’s experience?


    • It isn’t hard to see how, once the “sky is falling” claim fails, miserably, because there are no cases where forensic pathologists or physicians attributed death to MSCs, which, despite all this parsing of language, is nonetheless claimed in this blog over and over and over again, you might want to flip the question and ask me to prove the contrary. This is a simple, effective logical fallacy. Republicans love to use it: the burden to prove that MSCs have caused a death is on you, and your attempt to flip the burden of proof is a great example of how effective a rhetorical strategy it is to, in the absence of evidence, yell “prove the contrary!” But induction isn’t quite the same activity, is it…if you claim there are black swans among the white ones, and cannot provide evidence of one, you’re wrong. So you flip it and say “prove that there are no black swans!” This is a strategy that one only employs when one is unable to defend one’s claim, and it is usually employed alongside ad hominem attacks…which I must say I am delighted has not happened yet in this at least civil conversation.

      Alexey, your questions as to efficacy (and whether there is *any* efficacy are legitimate questions to which more than 200 authors have provided answers in more than 50 published articles in the more than 10 stem cell-germane peer-reviewed ISI-ranked journals that are thriving under an avalanche of data — more every year. There is so much evidence that I think maybe, just maybe, we should have another “thread” in the blog to discuss the problem of “evidence blindness” among those who discuss MSCs. How could you possibly be unaware, if you know how to type pubmed.org, of the volume of articles chronicling study and positive effects from MSC use in clinical trials? There aren’t enough slots to publish all the articles that get approved by peer reviewers in the decent stem cell journals and subspecialty journals that document efficacy. If we can find a way I will gladly, just for fun, paste 200 links to such articles into a post ON ANOTHER THREAD.

      Doug, again setting aside the question of this “mainstream” acceptance by the public of “unsupported claims,” which is of course a claim you make without any evidence, since all published evidence suggests exactly the opposite, you do address the question at hand. So, first, let’s get clear that the fact that people have died after a stem cell procedure (with or without scare quotes) is not the same as the non-fact that MSCs have themselves caused people to die. People have died during illegal abortions, clinical trials, and upon tripping on their way to the emergency room. They have died while on the table receiving a transplant. How many of them have died from a reaction to MSCs? Can you identify one. Just one. Please. We’ve all read tons of data that you could be referring to when you write that “several others have developed suspicious benign tumors, at least one of which was shown to be allogeneic in origin.” You could be making reference to all sorts of things. What ARE you making reference to, and what do you know that the peer-reviewed journals haven’t published, i.e., regarding any death ever caused by a tumor that is benign, suspicious, and pathologically determined to have been associated in any important respect with an MSC?
      I’d like to think that I’ve read every safety-related publication associated with MSCs, but if I’m wrong, please correct me. The remainder of your post is of the “change the subject” variety; in your case by way of a pivot to change the burden of proof: “Serious iatrogenic infections are also commonly reported. What worries lots of people is that the vast majority of such “stem cell” procedures are conducted without a solid basis in evidence.” No question that iatrogenic infections happen. Is there data that I am missing that suggests that they happen in greater frequency in infusion or injection of MSCs? (no). But that has nothing whatsoever to do with your next sentence about efficacy. Being worried about efficacy doesn’t mean being worried about death from stem cells. Let’s run another thread on efficacy and regulation and findings to date. For now the issue is simple. No logical tricks. Where’s the data, where are the cases? If you are going to post that the adult stem cells are lethal, and report that there have been many deaths, where’s the data about stem-cell specific deaths. Stem cell exceptionalism is really just rhetorical strategy. If we all agree that adult stem cells are enormously exciting, that they are presently subject to regulatory complexity that will be resolved using what are basically philosophical questions about the scope of the authority of regulatory bodies, and that there are bad people who do bad things who provide stem cells, we’ve not discovered that stem cells are on the tipping point. To prove that, we’d need to first demonstrate that absent unsanitary and/or incompetent medical practice, people die FROM STEM CELLS. And don’t get me started on the conflicts of interest here…

      I do appreciate the courtesy in the conversation though and there is much to be gained from an exchange about data and risk.


        • The burden of proof is on me? I didn’t allege that a tipping point leading to many dead people from stem cells was about to be reached. The trick about flipping burden of proof is that it *is* a trick. When called on the question, those who can’t prove the convenient fiction that MSCs kill people are not entitled to say that their statement is true until proven false. Nonetheless, since this point seems to be lost on you, let’s assess what we know. There have been thousands upon thousands of aMSC injections and infusions. There are many reports of autopsy and other study of deaths, by governmental and other inspectors in Europe, Asia and the U.S. at a minimum, in which alleged MSC toxicity was not established. There are many pre-clinical and human safety studies of MSCs. There are no published reports of deaths caused by MSCs. Now, mind you, these are just inconvenient facts. You can still continue to claim that corpses are piling up from lethal MSCs. But the burden to prove that claim is on those who make it. The regulatory burden to prove that MSCs are safe is on those who advance that claim. The difference is that the peer-reviewed literature is on the side of those who claim the safety (and existence) of MSCs.


      • Dr. McGee,
        I daily scan a PubMed and know the whole situation. I dedicated a whole project for tracking trials and published data –
        http://twitter.com/#!/CellTrials
        http://hematopoiesis.info/2011/05/09/tracking-clinical-trials-cases-cell-therapy-regenerative-medicine/
        There are no clinical trials which completed phase 2/3, and therefore proved to be effective. That’s why I’ve asked, what is the evidence for you? If not trials, don’t refer us to it. If you think publication of observations is enough, just say it. The problem is that more than 90% of professionals in the field currently think, that only trials can provide an evidence.
        I flip the coin, because popularization of the notion that everything is safe could lead to opposite – a belief that it’s effective and worth paying for. As I re-phrase you:
        “stem cell exceptionalism has successfully persuaded otherwise rational people into marketing that MSCs themselves are effective.”
        There is no black and white, and we frequently fall into extremes. So, is that safe – we still don’t know. Is that effective – we still don’t know.
        If you think, I’m wrong, please give a couple of links. I know pretty much all of them.


        • Mary,
          As you use pubmed you are well aware that there are hundreds of articles regarding animal and human safety and efficacy of MSCs, and 2011 was a record year with many papers published documenting clinical trials. One of them, which Turner cites above, involving a team from Korea and Germany (and RNL Bio) was described by leaders in stem cell research at Duke, Tulane and LSU, in their article about the study in the same issue of Stem Cells & Development, as a model for the demonstration that MSCs are safe, and praise the article for offering up a smart way to build regulatory frameworks. The bottom line is that this thread is not about efficacy. The thread is about a supposed tipping point after which there will be “piles of bodies.” I made a simple point. There are no studies that demonstrate that autologous MSCs themselves have been causal in a single death, even though there have been studies in great journals. Further, with all the forensics done in any case where allegations of harm have been made, governmental investigations — regardless of what ICMS or others concluded — have yet to find causal ties to MSCs. Can you imagine if a wonder drug prescribed off label to kids (which would be what percentage of prescriptions to kids??) had a record like that? NO ONE is alleging that physicians who engage in malpractice have not hurt or killed patients. Nor that this is irrelevant. I’m merely making one point which is that alleged blindness of the public toward huge risks of MSCs is nonsense, or rather, an inductive claim without evidence, no matter how eloquently it is made.


  3. Alexey beat me to just about every comment I was going to make. As I understand it, the “tipping point” Paul is referring to is the point at which unsupported claims about “stem cells” of various sorts for the treatment of various conditions becomes so mainstream that the pseudoscience drives out, or at least drowns out, legitimate study. Regarding deaths, clearly there have been numerous cases of people who died immediately after, even during, a “stem cell” procedure. Several others have developed suspicious benign tumors, at least one of which was shown to be allogeneic in origin. Serious iatrogenic infections are also commonly reported. What worries lots of people is that the vast majority of such “stem cell” procedures are conducted without a solid basis in evidence. This type of activity has been commonplace in other countries for a decade or so, but over the past 2-3 years, it has increased enormously in the US, particularly, as Paul notes, in cosmetic surgery, orthopedic, and “anti-aging” clinics.


    • Thanks, Doug. Yeah that’s part of what I mean by tipping point, but also I mean the point at which stem cell clinics reach a certain abundance that the FDA practically speaking simply is incapable of monitoring them. I think we may already be there or close….


  4. It appears that Dr. McGee lives in a bubble of convenience when discussing ethics, and the broader picture of how these so called “imaginary” corpses stack up. The patients and families both here and abroad are threatened, legally coerced, and shamed retroactively (after raising money in their communities) in to keeping their mouths shut. For example: (Copy and paste to browser) http://www.croydonguardian.co.uk/news/9531837.Family_wants_foundation_in_memory_of_paraplegic/r/

    The mother of this patient was driven to the airport to accompany her son’s body home by the Dr. that killed him. Telling her, that if she kept quiet, he would take care of the other expenses from hospital after he put him in a coma and showing her some YouTube video of an animal study on the drive there no less. I’m confident that this is not the first time that has happened based on other conversation’s I have had with parents regarding coercion.

    What is consistent is that those that would prefer this to not be known; They shout in CAP’s and talk in circles, are what I would identify as greedy, lacking in ethics and slink behind the skirt of a lawyer at the mere mention their small reality is questionable at best, while being willfully ignorant of the global damage to legitimate science they will ultimately be held accountable for. Very reminiscent of carnival barkers on the midway.


  5. Paul,

    Thanks for your thoughtful post concerning the proliferation of stem cell clinics within the United States. I’ve noticed the same trend as sports medicine clinics, cosmetic surgery facilities, and other businesses market various “stem cell” procedures. As the FDA warning letters to Young Medical Spa and Intellicell Biosciences reveal, many of these businesses pitch stem cells to patients even though safety and efficacy have not been demonstrated and the companies do not have valid biologics licenses or investigational new drug applications in effect. These practices raise numerous ethical, legal, and scientific concerns. Some patients pay tens of thousands of dollars for interventions that do not provide the benefits marketed by stem cell clinics. Of even greater concern, in both news reports and peer-reviewed publications there are accounts of patients who died following administration of stem cells. Given the emergence of stem cell clinics across the U.S., you are right to ask whether the FDA has the resources required to regulate these businesses and ensure that they conform to federal regulations. I hope you continue to address this subject despite Glenn McGee’s patronizing and insulting comments. I see that McGee now self-identifies as an Adjunct Professor in the Department of Bioethics at Kansas City University of Medicine and Biosciences. Were I a faculty member in that department I would be horrified to discover a colleague responding to you (and Doug Sipp) in this fashion.

    McGee asks, “Where’s the data, where are the cases?” Less than three months ago Glenn McGee was an executive at Celltex Therapeutics. Celltex’s corporate partner is RNL Bio. McGee writes, “If you are going to post that the adult stem cells are lethal, and report that there have been many deaths, where’s the data about stem-cell specific deaths.” RNL Bio, provider of the “stem cell technology” used by McGee’s former employer, is reported to have administered stem cells to over 10,000 individuals. And yet, of the few studies published by RNL Bio scientists, one article mentions 8 stem cell recipients and another one describes ten individuals who were administered autologous adipose tissue derived mesenchymal stem cells for “autoimmune hearing loss, multiple sclerosis, polymyotitis, atopic dermatitis and rheumatoid arthritis.” It appears that RNL Bio has not publicly disclosed safety and efficacy data on the other 9982 (and counting) stem cell recipients. In addition, there appear to be no peer-reviewed publications addressing reports of two RNL Bio clients who died after receiving stem cells as well as additional accounts of patients who experienced complications following administration of stem cells. “Where’s the data?” McGee asks. Yes, exactly. It is impossible to make informed assertions about safety and efficacy when stem cell clinics and other businesses with commercial interest in selling “stem cells” either drop all pretense of studying safety and efficacy and sell stem cell interventions outside the context of ethical, scientifically legitimate clinical trials or conduct poorly designed studies and selectively publish only results that advance their commercial interests.

    Federal regulations provide an ethical, legal, and scientific framework that helps protect patients by insisting that companies meet numerous standards before administering stem cells. The warning letters sent by the FDA to Young Medical Spa and Intellicell Biosciences provide insight into the operation of clinics that reportedly fail to meet these standards. Let us hope that we have not passed “the tipping point” and the FDA remains capable of responding to companies that market stem cells while failing to conform to federal regulations. And let us also hope that in future bioethicists promote patient safety and protection of research participants instead of attacking you and other stem cell researchers for warning that commercial interests could lead to a “stem cell disaster.”

    Leigh Turner


    • Leigh, I simply will not respond to your ad hominem arguments. I will say that you certainly have not in any way demonstrated that anyone has died from MSCs. Your confusing reference to RNL is actually quite helpful: the KFDA and Korean Ministry of Health BOTH conducted investigations to determine whether or not MSCs were in any way causally related to the deaths and both concluded that there was no evidence to suggest that the cells caused death.

      You write: ” It is impossible to make informed assertions about safety and efficacy when stem cell clinics and other businesses with commercial interest in selling “stem cells” either drop all pretense of studying safety and efficacy and sell stem cell interventions outside the context of ethical, scientifically legitimate clinical trials or conduct poorly designed studies and selectively publish only results that advance their commercial interests.” This is just an astonishing claim. Only someone who has not read the literature could make such a claim. The number of phase I, phase II, and phase III studies underway in MSCs is huge, and growing, and I personally have spent much of the last year working with people in many different labs and foundations and groups and yes, companies who want to, or have, develop[ed] comprehensive research programs. Your general view, which you’ve stated many many times, that ethics has no place working with anyone in industry, is preposterous and the vast majority of bioethics scholars disagree with you and have argued as much. As soon as you publish your first peer-reviewed article about stem cell research ethics and/or policy we can debate our respective positions but mine are on the record in books, articles, encyclopedia etc. and I think I’ve been pretty much fair minded and careful. Your conflation of journalism (which would typically involve fact checking) and scholarship (which would typically involve publishing and doing research) lets you say things about how someone’s colleagues should be ashamed, etc. But frankly I’m not going to play your game…I don’t care whether your colleagues enjoy reading your twitter and blog scholarship. Let’s keep it to the facts.


  6. Mary, that is a terrible story. The newspaper account sounds awful and you add details for us, and frost the whole thing with an account of how heartless I must be as the “corpses pile up.” But really, there should be some place for an actual conversation about the question as to whether or not there is a shred of evidence (in this case, say, from an autopsy) that MSCs have killed anyone? Including this young man? We’ve established that bad people can prey on the hopes of the vulnerable and, unqualified to practice medicine, hurt them by doing things that had nothing to do with stem cells. But one investigation after another, by governments, forensic pathologists, etc. has shown that in deaths associated with stem cells, the purported danger *of aMSCs* doesn’t exist. Hucksters use dirty needles and bad doctors and ridiculous surgical technique. So why isn’t your concern about ensuring that physicians who use MSCs, which have been subjected to phase I, I/II and II trials widely available in the peer-reviewed literature, do not commit malpractice? You certainly have given a great example of what malpractice causes. But “stem cell blindness,” which perhaps might be treated with hESCs, seems to prevent you from seeing that there is no — quoting you — “pile of corpses” caused by MSCs. In fact, there’s no corpse. Which is pretty astonishing, given the number of people who’ve received aMSCs globally.


  7. Documented greed would be the point I was making, as you provide nothing but conjecture to make your point. You seem perfectly at ease with your plausible deniability on the marketing aspect, which most definitely rides on the coat tails of corpses. As I understand, the Dr. from Ecuador in the Mr. Chick death is a member of the ICMS. So, where is that report?


    • Documented greed would be a great thread and there is no question that there are people who practice medicine (or even pretend to practice medicine) who are motivated by greed, dangerous, engage in malpractice, and hurt patients. The problem is that once you engage in stem cell exceptionalism and fault the cells for the problem, you miss the facts. Greed results in malpractice which results in deaths. Yup. Greed does not make MSCs unsafe. As to Mr. Chick, why are you asking me about ICMS? I don’t work for ICMS, but even if I did, ICMS is not the government. Ecuador and the US have responsibility for the related issues here and they will conduct the appropriate investigations at the appropriate levels if that is called for. I don’t know this case, which proves precisely one thing: I don’t know this case.


      • @ Glenn
        I’m asking you about the Mr. Chick case because the death occurred in August of 2009. You are clearly listed as a Director on page 7 sec (A) of the publicly assessable 990 IRS tax report submitted by ICMS for the fiscal year of 2010. I’d say that puts you (and others) exactly where you say you weren’t.


        • I’m sorry, are you asserting that because during 2010 I was on the board of directors of ICMS, I am responsible for the death in 2009 of Mr. Chick, or in some way greedy? I do not recall having encountered this case in 2010 nor is there any reason I would have. I am also on the editorial board of several stem cell journals. Am I responsible for the actions of every author who publishes in them? I am on the faculty or board of several organizations. Am I responsible for the actions of everyone with whom they relate? What is your specific claim, if any? It’s awfully easy to accuse anyone of anything. But accusing the person who worked on developing ethics programs at ICMS of complicity in the death of a patient in Ecuador strains credulity even on the most extraordinary account of fiduciary responsibility, don’t you think?


  8. Dr McGee,

    I didn’t see any autopsy reports on the investigations you collaborated on with ICMS? Surely you did not provide comprehensive reports without a full autopsy and medical records or allow your name to be attached to this?

    Do you realize what the impact of giving a report by a first world nation expert will have in a developing nation for families seeking compensation for wrongful deaths. It is not pretty, do you suppose ICMS or your buddies will pick up the tab…I think not , but surprise me…they claim to be there for the patient and safety….well how exactly?

    I agree it may be quite tiresome for you to hear the death rants until you see it face to face. I think that is the position often taken when ignoring the vulnerable and human suffering of others.

    Until then how about supplying well planned research with blinding, controls and relevant safety statistics.

    I am surprised that a bio-ethicist of your caliber would associate yourself with organizations that use your cells = drugs and other such nonsense to create sedition against the federal agency assigned to regulate safety.

    Vulnerable patients are too valuable to be used for human foils. Why not work with regulatory agencies to enact meaningful change and consider aligning your self with groups worthy of your intellect , passion, and experience.


    • Dear Amy,
      (1) As has been published numerous times, in fact so many that even the ICMS has noted it on its page, I did not participate in an investigation with ICMS. More important, the investigation to which you refer was autonomous, did not reach the conclusion you apparently think that it did, and had no power within any nation or among physicians or scientists because they are not a regulatory body. The relevant investigations were done by the governments of China, Japan and Korea, and all found that there was no discernible causal relationship between MSCs and the deaths. If you are worried about lawsuits in the developing world against physicians who commit malpractice, I can’t see why you’d think that my having been on the board of ICMS or having conducted a review of ethics practices would have any negative effect. Perhaps you did not read my report.
      (2) You write “Until then how about supplying well planned research with blinding, controls and relevant safety statistics.” As I noted above, there have been many published safety studies. If you would like to write me offline I would be happy to send you a bibliography of the ones that I’ve identified; I noted one above that should figure prominently in your analysis (it does in the 23 articles that cite it), since you attack the group that did that study.

      I believe that bioethics belongs everywhere and that bioethicists around the world who work with industry and government and foundations should do so without shame. Bioethics practiced by armchair is fine and I have been in a couple of those chairs in my 20 year career in bioethics. I’ve also participated in many studies of vulnerable subjects in research including in the developing world, in gene therapy etc. I believe that the notion that companies should “go it on their own” without a bioethicist in the field of stem cells is ridiculous and that with any luck there will not be a group in the world that works with humans and stem cells that does not have bioethics research among its priorities.

      The bottom line is that if you want me to apologize for working with stem cell companies to help them develop ethical research programs and education programs for their staff and policy analysis, I won’t. I’m a pragmatist and I’ve spent the last three months being attacked in every conceivable way by a small gang of people who absolutely positively believe that industry is evil. If you’re among them, count me as unsurprised that you’d think that bioethicists shouldn’t have anything to do with stem cell industry. Either way, the data is out there and it is obvious that main line approved drugs cause many many more deaths, from their own toxicity, than are experienced by those who have received MSCs, and moreover that toxicity is demonstrably causal, whereas the article suggesting that MSCs are lethal to humans has yet to be published — among many that suggest the contrary.


  9. It seems advisable to address the Black swan issue apart from stem cells to add a little humor and perspective:
    The Bayesian story reminds me of an old joke:

    A child, a philosopher, a statistician and a mathematician are on a train to Wales. The child looks out of the window, sees a black sheep standing in a field, and squeals delightedly, “Oh look. Welsh sheep are black.” “Tut, tut” admonishes the philosopher “No, you can only conclude that some Welsh sheep are black.” The statistician shakes his head at the lack of precision and says “At least one sheep in Wales is black”, the mathematician rolls his eyes at such sloppy thinking and says, “In Wales, there is at least one sheep, which has at least one side that is black, or appears to be black from here.”

    And we could add to this: an economist would say, “Let’s assume that all sheeps are black, which is an empirically true assumption, and then we could develop a model to predict the movement of sheep based on its color.” Afterward, a financial economist will sell you a white paint to “achieve competitive advantage”.

    To say things clearly the assumption seems to be that Bayesian methods don”t require randomised trials. RCTs are all about getting rid of bias and confounding – this is sound scientific method, where it is ethically appropriate and logistically feasible, to test the effects of interventions. This is true whether you are going to use frequentist or Bayesian methods to interpret the results.

    Moreover the need for trials does not conflict with the need for registries – registries can be useful and serve a different purpose to randomised controlled trials e.g. follow up for rare adverse events. And, yes, animal models can be misleading if they don’t reflect the reality of a situation (e.g. IV fluid replacement – the original animal model involved removing blood until the animal was hypotensive and seeing whether it survived better if saline was infused. It did. However this was a “closed” system and most human trauma the patient is still bleeding. The later animal models modelled this by nicking the aorta so that the animal was still bleeding.) Neither of these however has anything to do with Bayesian versus frequentist methods so why bring them up?

    One last fable to assist your reason:

    “A young turkey was brought into a farm and was fed regularly every morning at the same time with a fresh supply of grass. Like any other being interested in the future, he wanted to convincingly predict the future and not use the first few days of his life as an indicator of things to come. Having an erudite lineage, he figured he should not commit the fallacy of jumping the gun to reach a conclusion and instead would gather a large data set for his observation.

    After 364 days, drawing from the specific instances, he concluded the obvious generalization – he would be well fed every morning until he grew old and died. Unfortunately, the very next day was Thanksgiving and the turkey was slaughtered and became the star meal of the day at the farmer’s house.”

    So Please all anyone is asking here is for scientific method appropriately applied without getting off on rabbit trails. We should not need to see or hear about deaths before we track safety and efficacy, the goal is to deliver quality science and medicine not to wait for the worst and then argue about fixing it … real data for safety and efficacy. Now how hard is that?


    • The jokes are funny, the point is well taken that RCTs are important and most of all we must not accept anything less than good strong safety data. However, when we are staring the good strong safety data in the face, pre-clinical and clinical, we also must not ignore it. At least as far as aMSCs are concerned here are a few of the studies that “don’t exist” regarding safety, characterization, ‘homing’, etc. Extraordinary research teams at Penn and Cambridge have published more recent safety data in more recent publications (phase I and II respectively) but I don’t have my library ID with me so I’ll just paste a few:
      Ra JC et al. (2011) Safety of intravenous infusion of human adipose tissue-derived mesenchymal stem cells in animals and humans. Stem Cells Dev. 20(8): 1297-1308. 2011. PMID: 21303266.
      Gimble JM, Bunnell BA, Chiu ES, Guillak F. (2011) Taking stem cells beyond discovery: a milestone in the reporting of regulatory requirements for cell therapy [Editorial regarding (1)] Stem Cells Dev 20(8): 1295-1296. 2011.
      Chamberlain, G., J. Fox, et al. (2007). “Concise review: mesenchymal stem cells: their phenotype, differentiation capacity, immunological features, and potential for homing.” Stem Cells 25(11): 2739-2749.
      Crespo-Diaz, R., A. Behfar, et al. (2010). “Platelet lysate consisting of a natural repair proteome supports human mesenchymal stem cell proliferation and chromosomal stability.” Cell Transplant.
      Francois, S., M. Bensidhoum, et al. (2006). “Local irradiation not only induces homing of human mesenchymal stem cells at exposed sites but promotes their widespread engraftment to multiple organs: a study of their quantitative distribution after irradiation damage.” Stem Cells 24(4): 1020-1029.
      Lapidot, T., A. Dar, et al. (2005). “How do stem cells find their way home?” Blood 106(6): 1901-1910.
      Levi, B., A. W. James, et al. (2010). “Depot-specific variation in the osteogenic and adipogenic potential of human adipose-derived stromal cells.” Plast Reconstr Surg 126(3): 822-834.
      Liras, A. (2010). “Future research and therapeutic applications of human stem cells: general, regulatory, and bioethical aspects.” J Transl Med 8: 131.
      Maijenburg, M. W., W. A. Noort, et al. (2010). “Cell cycle and tissue of origin contribute to the migratory behaviour of human fetal and adult mesenchymal stromal cells.” Br J Haematol 148(3): 428-440.
      Malgieri, A., E. Kantzari, et al. (2010). “Bone marrow and umbilical cord blood human mesenchymal stem cells: state of the art.” Int J Clin Exp Med 3(4): 248-269.
      Meyerrose, T. E., D. A. De Ugarte, et al. (2007). “In vivo distribution of human adipose-derived mesenchymal stem cells in novel xenotransplantation models.” Stem Cells 25(1): 220-227.
      Mitchell, J. B., K. McIntosh, et al. (2006). “Immunophenotype of human adipose-derived cells: temporal changes in stromal-associated and stem cell-associated markers.” Stem Cells 24(2): 376-385.
      Mizuno, H. (2009). “Adipose-derived stem cells for tissue repair and regeneration: ten years of research and a literature review.” J Nippon Med Sch 76(2): 56-66.
      Mizuno, H. (2010). “Adipose-derived stem and stromal cells for cell-based therapy: current status of preclinical studies and clinical trials.” Curr Opin Mol Ther 12(4): 442-449.
      Pelacho, B., M. Mazo, et al. (2010). “Adult Stem Cells: From New Cell Sources to Changes in Methodology.” J Cardiovasc Transl Res.
      Ra, J. C., I. S. Shin, et al. (2011). “Safety of intravenous infusion of human adipose tissue-derived mesenchymal stem cells in animals and humans.” Stem Cells Dev.
      Sensebe, L., P. Bourin, et al. (2011). “Good manufacturing practices production of mesenchymal stem/stromal cells.” Hum Gene Ther 22(1): 19-26.
      Shi, M., J. Li, et al. (2007). “Regulation of CXCR4 expression in human mesenchymal stem cells by cytokine treatment: role in homing efficiency in NOD/SCID mice.” Haematologica 92(7): 897-904.
      Tat, P. A., H. Sumer, et al. (2010). “The efficient generation of induced pluripotent stem (iPS) cells from adult mouse adipose tissue-derived and neural stem cells.” Cell Transplant 19(5): 525-536.
      Vilalta, M., I. R. Degano, et al. (2008). “Biodistribution, long-term survival, and safety of human adipose tissue-derived mesenchymal stem cells transplanted in nude mice by high sensitivity non-invasive bioluminescence imaging.” Stem Cells Dev 17(5): 993-1003.
      Yoshimura, K., T. Shigeura, et al. (2006). “Characterization of freshly isolated and cultured cells derived from the fatty and fluid portions of liposuction aspirates.” J Cell Physiol 208(1): 64-76.
      Zou, Z., Y. Zhang, et al. (2010). “More insight into mesenchymal stem cells and their effects inside the body.” Expert Opin Biol Ther 10(2): 215-230.
      Zuk, P. A. (2010). “The adipose-derived stem cell: looking back and looking ahead.” Mol Biol Cell 21(11): 1783-1787.
      Zuk, P. A., M. Zhu, et al. (2001). “Multilineage cells from human adipose tissue: implications for cell-based therapies.” Tissue Eng 7(2): 211-228.

      And just because it refuses to die in this thread, I picked one area where numerous studies have been done regarding effect, that of cardiac damage, and pasted a few citations:

      Amado, L. C., A. P. Saliaris, et al. (2005). “Cardiac repair with intramyocardial injection of allogeneic mesenchymal stem cells after myocardial infarction.” Proc Natl Acad Sci U S A 102(32): 11474-11479.
      Arom, K. V., P. Ruengsakulrach, et al. (2008). “Intramyocardial angiogenic cell precursor injection for cardiomyopathy.” Asian Cardiovasc Thorac Ann 16(2): 143-148.
      Ayala-Lugo, A., A. M. Tavares, et al. (2010). “Age-dependent Availability and Functionality of Bone Marrow Stem Cells in an Experimental Model of Acute and Chronic Myocardial Infarction.” Cell Transplant.
      Bai, X. and E. Alt (2010). “Myocardial regeneration potential of adipose tissue-derived stem cells.” Biochem Biophys Res Commun 401(3): 321-326.
      Bai, X., Y. Yan, et al. (2010). “Both cultured and freshly isolated adipose tissue-derived stem cells enhance cardiac function after acute myocardial infarction.” Eur Heart J 31(4): 489-501.
      Bai, X., Y. Yan, et al. (2010). “Tracking Long-Term Survival of Intramyocardially Delivered Human Adipose Tissue-Derived Stem Cells Using Bioluminescence Imaging.” Mol Imaging Biol.
      Berry, M. F., A. J. Engler, et al. (2006). “Mesenchymal stem cell injection after myocardial infarction improves myocardial compliance.” Am J Physiol Heart Circ Physiol 290(6): H2196-2203.
      Carr, C. A., D. J. Stuckey, et al. (2008). “Bone marrow-derived stromal cells home to and remain in the infarcted rat heart but fail to improve function: an in vivo cine-MRI study.” Am J Physiol Heart Circ Physiol 295(2): H533-542.
      Chen, G., M. Nayan, et al. (2010). “Marrow stromal cells for cell-based therapy: the role of antiinflammatory cytokines in cellular cardiomyoplasty.” Ann Thorac Surg 90(1): 190-197.
      Dai, W., S. L. Hale, et al. (2005). “Allogeneic mesenchymal stem cell transplantation in postinfarcted rat myocardium: short- and long-term effects.” Circulation 112(2): 214-223.
      Danoviz, M. E., J. S. Nakamuta, et al. (2010). “Rat adipose tissue-derived stem cells transplantation attenuates cardiac dysfunction post infarction and biopolymers enhance cell retention.” PLoS One 5(8): e12077.
      Forrester, J. S., M. J. Price, et al. (2003). “Stem cell repair of infarcted myocardium: an overview for clinicians.” Circulation 108(9): 1139-1145.
      Grauss, R. W., E. M. Winter, et al. (2007). “Mesenchymal stem cells from ischemic heart disease patients improve left ventricular function after acute myocardial infarction.” Am J Physiol Heart Circ Physiol 293(4): H2438-2447.
      Guo, J., G. S. Lin, et al. (2007). “Anti-inflammation role for mesenchymal stem cells transplantation in myocardial infarction.” Inflammation 30(3-4): 97-104.
      Gutierrez, E., R. Sanz-Ruiz, et al. (2010). “General Overview of the Seventh International Symposium on Stem Cell Therapy and Cardiovascular Innovations.” J Cardiovasc Transl Res.
      Hare, J. M., J. H. Traverse, et al. (2009). “A randomized, double-blind, placebo-controlled, dose-escalation study of intravenous adult human mesenchymal stem cells (prochymal) after acute myocardial infarction.” J Am Coll Cardiol 54(24): 2277-2286.
      Hwangbo, S., J. Kim, et al. (2010). “Therapeutic potential of human adipose stem cells in a rat myocardial infarction model.” Yonsei Med J 51(1): 69-76.
      Ii, M., M. Horii, et al. (2010). “Synergistic effect of adipose-derived stem cell therapy and bone marrow progenitor recruitment in ischemic heart.” Lab Invest.
      Joggerst, S. J. and A. K. Hatzopoulos (2009). “Stem cell therapy for cardiac repair: benefits and barriers.” Expert Rev Mol Med 11: e20.
      Kraitchman, D. L., A. W. Heldman, et al. (2003). “In vivo magnetic resonance imaging of mesenchymal stem cells in myocardial infarction.” Circulation 107(18): 2290-2293.
      Leobon, B., J. Roncalli, et al. (2009). “Adipose-derived cardiomyogenic cells: in vitro expansion and functional improvement in a mouse model of myocardial infarction.” Cardiovasc Res 83(4): 757-767.
      Lin, Y. C., S. Leu, et al. (2010). “Early combined treatment with sildenafil and adipose-derived mesenchymal stem cells preserves heart function in rat dilated cardiomyopathy.” J Transl Med 8: 88.
      Miyahara, Y., N. Nagaya, et al. (2006). “Monolayered mesenchymal stem cells repair scarred myocardium after myocardial infarction.” Nat Med 12(4): 459-465.
      Mohyeddin-Bonab, M., M. R. Mohamad-Hassani, et al. (2007). “Autologous in vitro expanded mesenchymal stem cell therapy for human old myocardial infarction.” Arch Iran Med 10(4): 467-473.
      Okura, H., A. Matsuyama, et al. (2010). “Cardiomyoblast-like cells differentiated from human adipose tissue-derived mesenchymal stem cells improve left ventricular dysfunction and survival in a rat myocardial infarction model.” Tissue Eng Part C Methods 16(3): 417-425.
      Planat-Benard, V., C. Menard, et al. (2004). “Spontaneous cardiomyocyte differentiation from adipose tissue stroma cells.” Circ Res 94(2): 223-229.
      Psaltis, P. J., A. C. Zannettino, et al. (2008). “Concise review: mesenchymal stromal cells: potential for cardiovascular repair.” Stem Cells 26(9): 2201-2210.
      Rigol, M., N. Solanes, et al. (2010). “Effects of adipose tissue-derived stem cell therapy after myocardial infarction: impact of the route of administration.” J Card Fail 16(4): 357-366.
      Ripa, R. S., M. Haack-Sorensen, et al. (2007). “Bone marrow derived mesenchymal cell mobilization by granulocyte-colony stimulating factor after acute myocardial infarction: results from the Stem Cells in Myocardial Infarction (STEMMI) trial.” Circulation 116(11 Suppl): I24-30.
      Rodriguez-Serrano, F., P. Alvarez, et al. (2010). “Promotion of human adipose-derived stem cell proliferation mediated by exogenous nucleosides.” Cell Biol Int 34(9): 917-924.
      Schenke-Layland, K., B. M. Strem, et al. (2009). “Adipose tissue-derived cells improve cardiac function following myocardial infarction.” J Surg Res 153(2): 217-223.
      Sheikh, A. Y., S. A. Lin, et al. (2007). “Molecular imaging of bone marrow mononuclear cell homing and engraftment in ischemic myocardium.” Stem Cells 25(10): 2677-2684.
      Tao, Z. W. and L. G. Li (2007). “Cell therapy in congestive heart failure.” J Zhejiang Univ Sci B 8(9): 647-660.
      Valina, C., K. Pinkernell, et al. (2007). “Intracoronary administration of autologous adipose tissue-derived stem cells improves left ventricular function, perfusion, and remodelling after acute myocardial infarction.” Eur Heart J 28(21): 2667-2677.
      Valina, C., K. Pinkernell, et al. (2007). “Intracoronary administration of autologous adipose tissue-derived stem cells improves left ventricular function, perfusion, and remodelling after acute myocardial infarction.” Eur Heart J 28(21): 2667-2677.
      Wang, L., J. Deng, et al. (2009). “Adipose-derived stem cells are an effective cell candidate for treatment of heart failure: an MR imaging study of rat hearts.” Am J Physiol Heart Circ Physiol 297(3): H1020-1031.
      Zhu, Y., T. Liu, et al. (2010). “Enhancement of adipose-derived stem cell differentiation in scaffolds with IGF-I gene impregnation under dynamic microenvironment.” Stem Cells Dev 19(10): 1547-1556.

      Perhaps you would be so kind as to paste the single citation that *suggests* lethality of aMSCs?


      • Sorry — meant to post this adjacent to the original list of citations:

        Sorry — here are the cites I couldn’t get to without an ID.
        1) safety and efficacy of MSCs in treatment of Multiple Schlerosis: http://www.ncbi.nlm.nih.gov/pubmed/22236384
        Autologous mesenchymal stem cells for the treatment of secondary progressive multiple sclerosis: an open-label phase 2a proof-of-concept study.
        Connick P, Kolappan M, Crawley C, Webber DJ, Patani R, Michell AW, Du MQ, Luan SL, Altmann DR, Thompson AJ, Compston A, Scott MA, Miller DH, Chandran S.
        Source
        Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK.

        2) MSC study at Penn – news release describing study published in Cell: http://www.upenn.edu/pennnews/news/university-pennsylvania-researchers-adult-stem-cells-are-touchy-feely-need-environmental-clues-

        3) MSC study I was thinking of which was actually at Penn State (oops): http://www.bbmt.org/article/S1083-8791(10)00195-3/abstract


        • Dr. McGee,
          You wrote: “There are many reports of autopsy and other study of deaths, by governmental and other inspectors in Europe, Asia and the U.S. at a minimum, in which alleged MSC toxicity was not established.”

          Can you please provide links to those reports or cite them here? How many have you seen?

          I’m studying peer-reviewed literature daily and didn’t see autopsies reports after MSC infusion/ transplantation.


          • What my group did was take reports of adverse events related to stem cells and then make open records requests for autopsy records where available and where findings had not been summarized in the print media with quotes from the forensic official/agency. This “content analysis” methodology is difficult — much more so than one expects going in — and inter-coder reliability is less the problem than getting the materials in a form that allows for a body of literature that is of the same kind. Upshot is that we never published it and it was last updated in June of 2011. I’d be happy to send it along by email though with the proviso that it is not for publication or citation; please just email me the email address to which you’d like it sent. You can do much of what we did using Lexis/Nexis if you want to update. I’d welcome a collaborator in that effort as the group that worked on it has disbanded long ago. ~ g


            • Actually I should also put the question back to you — have you identified a single autopsy report, or reference to such a report, that in any way linked MSCs themselves to deaths?


        • Dr. McGee,

          Thank you for taking the time to post these cites. I will read them carefully and consider how to get back to you offline. I am glad you liked the jokes. I did reread your posts and sense I may have misunderstood your focus and for that I apologize.

          Could it be said that you wish to establish that the cells themselves when delivered responsibly in clean labs and with appropriate specialist care from cell to patient are not being reported as the cause for deaths but rather it is operator error when these arrangements break down that are creating the reported problems? Are you saying it is unreasonable to make the cells themselves culpable for operator error and you are concerned that the cells themselves are being repeatedly put on trial?

          If my interpretation is now accurate we share an important focus for safety in respect to laboratory conditions, the level of medical care and follow up provided plus the form of clinic ‘ORs” where they are administered, processed and at times cultured.

          I read the report that was combined with the ICMS. It co-existed since the investigation with no clear lines of demarcation until recently. My personal observation was that the investigation did not go deep enough and the recommendations were too little, too late and with too much time given to those investigated to resolve existing and patient harming issues. I would be happy to reread the portions of the report authored by you as it may be that the surrounding copy influenced my overall perspective.

          When people are harmed by unethical practice my sense of justice is aroused. My contribution was to reiterate only that crowd sourcing vulnerable persons and turning them against the FDA so they can manipulate the tide of public opinion to the vulnerable one’s own hurt is not an ethical position I celebrate or endorse. This in my opinion amounts to hiding behind patients and using them for human shields. To use your cells = drugs slogans along with the rhetoric that the FDA takes away your right to use your own cells is a dichotomous over simplification that is bad science and unacceptable medicine. It is the philosophy and mindset behind this thinking I address not any one organization in particular. The rhetoric is widespread and who knows where it started.

          Many of the papers you cite here were conducted with more appropriate oversight than what is happening in clinics across the nation. There it is a much different picture.

          It is difficult to remain only an armchair critic when I see people up close who have been harmed through the treatment of cells received in unregulated labs and accompanied by substandard medical care. This hurts people and funding for those trying to do their best within an existing regulatory framework.

          I do not expect you to apologize for anything. I would only hope that you would seriously consider the fruit of your labor and how well your recommendations are respected by how thoroughly they are acted on. Even in situations where the results are not as strong as would be hoped the final call and responsibility rests with the decision maker. Many scientists and academics follow you and they respect your opinion and they practice what you endorse. I agree that bio-ethicists are needed within industry to promote best practice.

          I am not opposed to a re-examination of regulation or expediting due process and I see the need to explore collaborative pathways. I feel the present climate is ripe for change and there is considerable unrest. I am concerned that combative collaboration with those that choose to defy present regulation is not the pathway to excellence in science, medicine or ethics.


          • I appreciate your extremely thoughtful comment and I will take a bit to try to see if I have anything to add to what seem reasonable and smart observations. I think that this exchange (the entire 30+ messages) demonstrates the difficulty introduced by both the inherent difficulties in identifying ‘what’ one is discussing in the area of stem cells, which since 1998 (at least) has been such a problem as we all attempt to find ways to describe “what’s in the dish” as well as “what is happening” and “who is doing it”. But even after those problems are presented, there are so many others, many that you’ve mentioned, that involve not only well intentioned yet divergent views on the introduction of these technologies and the regulations to govern them but also less well-intentioned views grounded in politics, money, or philosophical views that go unstated but inform ill-considered suggestions (the person who believes industry is evil seems to always say that the ethicist working with industry is evil by association, even though that person’s own salary is paid by university money from untoward sources including industry). The most abrasive claims, in general, also seem to come from those least published in the field. I am just as worried about the U.S. going “guns blazing” into a rampant, ill-considered regulatory enforcement fury, before truly examining the philosophical and scientific questions at hand, as I am about the supposed rush to build “clinics” across the nation. Temperance is called for and carefully critical exchange. And for the most part that is what this thread has been, and your comment shows that those dedicated to responsible stem cell progress can “get along” and work toward mutually held goals…I think so, anyway!


  10. Paul, The FDA will certainly be able to “keep up with them” They can take that to the bank or to jail, it is their choice.

    As for deadly consequences of stem cell transplants, do you live in s cave? These have been not unexpected, not insignificant and well publicized. A new product must be both safe and effective to meet FDA approval. As ALEXY suggests, stem cells seem to work wonders in people’s minds, but not in the clinic. You are a voice in this field that has defined inappropriate hype in theraoy, How long after Dr, Salk developed the polio vaccine was FDA approval delayed? It was not, It met approval befire Dr. Salk’s clinical trial ended, It ended because it was terminated after only 4 months, The studry was proposed to last a year, Geron took a lot longer to reach the conclusion that despite an earlier derining report that everyine seems to forget the video that captured national interest when shown against the background of the heroic and parakysed actor CHris Reeves. The author would later become CEO of Geron, And he eventually published his resuts in JCI. What he failed to emphasize is that the rats he treated with human “gastrational” stem cells didnt have a severed spine; they had a totally reversible consussion injury. Slight difference? GIve me a break.

    It is clearly time for stem sellers to as you ask detractors “put up or shut up”. No prospective randon studies show –despite report after report of case history and praises from individual patients– that stem cell therapy benefits anyone but the physician selling it, This will certainly change when the basic problem is identified. Unfortunately the rush to the clinic, and its attendant highly inappropriate critiue of responsible FDA staffers who are under fire from everyone from Peyton Manning to the Goverenor ot Texas and who well trained to stop catstrophic therapy before it reaches that level and who I am fairlh sure have put a lot more professional experience, thought ane evaluation into this matter than the combined members of this group obviously — obviously Paul–see a tragedy about to happen and they are not goiing to allow it. Have they been mistake before?

    I really dont think so.

Comments are closed.