Predatory stem cell clinics are winning the war; what can we do?

For years I have been working to educate the community about the predatory stem cell clinics out there. These clinics prey on vulnerable patients and their families. The clinics use hope as a marketing tool.

A weapon.

As the number of such clinics has mushroomed in the US and elsewhere the risk to both patients and to the larger stem cell community proportionately rises too. We are in a situation today where the dangers from such clinics have never been higher.Stem cell facelift comic

They are making millions in profits with little-to-no accountability. Their therapies don’t have to work or even be proven safe. It’s odd because many consumers seem to expect more from non-health-related businesses such as McDonald’s or computer companies than from stem cell clinics.

Thousands of patients just in the US alone are regularly being subjected to experimental, non-FDA approved interventions. They are spending millions of dollars and being put at substantial risk.

Many patients are desperately looking for hope so they are very driven to find something that may help and are often willing to take unknown risks.

Some of us in the stem cell community are working to try to make some positive impact in this area. I believe we are making a difference, but overall the dubious stem cell clinics are winning the war.

Why are the clinics prevailing so far?

In part it is because they’ve been very smart about how they do business.

For instance, they do PR like pros, they manipulate some members of the media to almost in essence work as their spokespeople, they use social media to great effect, and they’ve won over some powerful allies in the form of certain patient advocates who have become in effect stem cell clinic advocates.

An illustration of the cleverness of the clinics is their move to take advantage of to list their non-traditional, profit-driven business as if it were real clinical trials. They even go so far as to say that just because their work is listed in that database that their offerings are FDA-approved. They aren’t.

The stem cell clinics are also winning because the FDA has been so passive and ineffective, particularly during the last two years. Further in the past the FDA and more specifically the CBER division within the FDA that is tasked with dealing with stem cells took steps to regulate the stem cell clinic industry through actions such as warning letters. In contrast, lately CBER hasn’t done anything (at least apparent in the public domain and via FOIAs I’ve submitted) on the stem cell clinic problem.

This apparent regulatory passivity couldn’t come at a worse time either as the stem cell clinics proliferate like crazy in the US. There’s certainly a connection there. Less regulatory action = more dangerous clinics. It’s frustrating because CBER of course remains very active with the good citizens of the stem cell world such as those in academia and legit biotechs with appropriately high expectations for them.

Hello, CBER, are you home? Are you paying attention? Patients need to be protected.

I’ve tried talking with the FDA to get at the root of the stem cell clinic problem, but things remain nebulous. Are they afraid of being sued? Just too slow? Don’t have the budget? Maybe part of the problem is the leadership transition at the FDA where there hasn’t been a commissioner…but I think that’s only part of the story.

The FDA took a healthy step last year in issuing draft guidance (see my interview here with the FDA on the draft guidance) to regulate fat stem cell products that are almost certainly biological drugs requiring approval, but that’s been about it and those draft guidances have not been finalized. Until finalized, the draft guidances have no teeth. Meanwhile the fat stem cell clinics and others that sell unapproved stem cell biologics of various kinds such as amniotics, take advantage of this gray area to milk patients for millions of dollars all the while putting such patients at risk. The clinics are literally laughing at the FDA all the way to the bank.

Why should you care about this as a stem cell researcher, patient advocate, or other interested party? As has happened in the past, people are going to get hurt or killed at these clinics, and not only is that a tragedy unto itself, but also it will reflect badly on the whole stem cell arena. This magnifies the negative impact.

The unchecked stem cell clinic industry also has other negative effects such as muddying the waters for patients over just what is (and what isn’t) a legit stem cell therapy and research. We are also seeing some at academic institutions starting to give in to temptation and work with the dubious clinics too probably for the big bucks involved. In short, the war isn’t going well and the risks are growing.

So what do to?

We need to push the FDA to act more consistently, quickly, and forcefully on this problem. Maybe they think they are acting on it, but from my view it seems to be in slow motion. A recent poll on my blog indicates a larger sense within the stem cell community that the FDA isn’t being effective on stem cell clinics. And by my own calculations, the number of stem cell clinics in the US alone is skyrocketing. The FDA doesn’t have much time.

If more patients are injured or even die after getting questionable stem cell therapies, in a sense the FDA will bear part of the blame because of their ineffectiveness.

We also need organizations to step up to the plate and confront the clinics as well. When individuals such as myself and others including Leigh Turner and Doug Sipp do this, we have had some positive impact, but at great risk to ourselves. It is literally dangerous for us. I have been threatened with litigation and literally threatened to be attacked or killed.

Educational efforts can also be helpful and that is a major mission of this blog.

In the absence of timely FDA action, an out of control stem cell free market is churning. In January of this year I called it a “wild west” of medicine. It really feels that way. There’s demand so there will be supply. Something fundamental needs to change or the war is over and patients lose out, as does the stem cell field.

41 thoughts on “Predatory stem cell clinics are winning the war; what can we do?

  1. Paul I believe one of the problems is that people like me, who are looking for treatment would like to discuss options with a researchers or doctor who is doing work in the area that they wish to seek treatment rather than a person running a clinic. I have email 2 people including you to try and find information and never got a reply. Yes we all play the hope game as none of us want to die but some of us are also willing to go out on a limb to try new or part experimental treatments knowing full well they may not work. Money is just money and you can’t take it with you but one’s health and a future is paramount to most of us. Why should we have to wait for the last breath before we are offered treatment which many times may still experimental? Is this so you can say, oh we tried but he was too far gone to help?? I would rather start before I get to that position.
    On the 31st January 2009 I had an anterior STEMI complicated by VF arrest x 2
    o Extensive anterior akinesis.
    o 16 January 2010 – PCI to severe LAD stenosis
    o 11 June 2010 – angiography unchanged from post PCI angiogram 2010.

    Since then I have had 2 treatments of Adipose Derived Stem Cell (ADSC) treatment via IV done in New Zealand. One in April 2012 which improved my heart and kidney function by about 15% and the second in March 2014 which also gave me improvement but unfortunately not as much. As mentioned in my email I would like to know of anyone who is working on heart stem cell treatment as I feel this has potential.
    Someone to talk to as I mentioned may help but not sure how this could ever be achieved as I know you all are extremely dedicated and busy.

    Thank you for your great work in keeping us informed via your blog.

    • @David,
      Thanks for the comment and sharing your story.
      I apologize for not replying to your email. I don’t see it in my email. It might have gotten filtered out. I’m not sure. I get a kajillion emails and I do try to reply to as many patient emails as possible, but I’m only human.
      I get what your saying. I’ve been advocating also for FDA reforms including quicker decisions and better communication by the agency. I also put out there a stem cell patient’s bill of rights.
      Take care,

  2. What you can do is let patients make their own health care decisions, just like David did and thousands of others. You constantly try to claim that patients are at great risk, but provide no real proof of that. You fail to understand that the very disease that one might suffer from and all the horrible FDA approved drugs that one is given to treat the symptoms, are far riskier than trying an experimental stem cell treatment. There are numbers to prove that.

    As David mentioned, many patients are willing to try. The risk is mainly financial if the treatment should deliver no improvements. As David said, you can’t take it with you.

    I’m just disappointed that you have made this a constant theme. We all get that you are frustrated that things aren’t going the way you want with the FDA. I don’t know why anyone would threaten to hurt you, but if your mission is too dangerous, why are you taking such a risk? It’s not worth it considering that you have had little impact apparently on stopping the proliferation of clinics or in getting the attention of the FDA.

    • @Barbara,
      I have a great deal of respect for patients and their rights to make decisions with their personal physicians.
      Our system of healthcare it isn’t anarchy where patients have to go it alone. We have laws and rules that healthcare providers, clinical experimenters, and organizations such as clinics must follow. These laws and rules are in place in part to protect patients. One of my goals is to inspire positive changes and increase dialogue overall with the FDA, which could definitely use some reform in multiple ways including being less glacial in how it does things. I get that for some patients there is a legitimate sense of not having time to wait for the slow wheels to turn at the FDA. On the other hand without the FDA and without physicians following the rules, patients can be as serious risk. I do not agree with you that the risk is mainly financial. While there is financial risk, there are also health risks to going to many of these clinics and being part of what is a for-profit, unapproved experiment.
      Why do I keep on advocating despite the challenges? I feel passionately about education and legitimate uses of stem cells to help people.

  3. I do believe the FDA is doing more than enough, and they are shutting down clinics.
    If new entrants misbehave og do not follow the rules set by the FDA they are shut down. You can not set regulations, and then deny patients treatment because you and your mighty ethics do not like it – your thoughts are truly communistic! Sorry, but trying to regulate like you want is.
    Since you wanted to know what to do I strongly suggest that you take a hard look at your ethics and hopefully you will learn that this is not based on the patient best interest, and therefore should be looked at as unethical.

    • @Bjorn,
      We disagree. That doesn’t make either one of us “unethical”. I’m not aware of the FDA shutting down any clinics in the last few years.

  4. Hi Paul,
    First of all I want to thank you for doing what you do,both professionally and here with your blog.I read this blog and every other piece of news about stem cells every day to see what is happening both in the U.S. and elsewhere.
    I have Parkinsons and I don’t want to wait until Hell freezes over to try and get something that could help me.I won’t bore you with what it is like to have your own brain turn against you.For me,current treatments give me 3 or 4 hours a day where I’m not miserable.
    I have to say that this post reminds me of last nights Republican debate.Many of the candidates try to use fear and threats of calamity to get votes.We are told that the world is coming to an end if we don’t change course.It’s what if this and what if that.
    As I read every day, I don’t see the dangerous complications and deaths that we’re being told will happen.While stem cell treatment may not work for everyone,it does seem to be safer than we are being led to believe.Personally,I think the failures have more to do with the type of stem cells being used.
    HESC’s are called the Gold Standard,yet we continue not to fund them and force patients to undergo inferior treatments of adult stem cells just to appease the Mythologists.Why would drive a Yugo when you have a Porche in the garage?Opponents would rather throw embryos away than use them to help suffering patients.We don’t have to destroy embryos to get stem cells.That’s a choice the NIH has made.
    So besides the lady that grew a nose on her back, I just don’t see where all the fear is coming from.Properly differentiated cells don’t seem to cause tumors and we are even finding out that all this immune suppression does more harm than good.
    It should be my decision whether or not I want to try this technology.I should not have to leave the country to get treatment.I can give my life for this country if I want to go half way around the world to fight terrorism,but I can’t do the same to try and save my own life or maybe the next poor smuck that gets this disease.

    What happened to life,liberty,and the pursuit of happiness?
    It’s my life and should be my choice.

    • Hi Edward,
      Thanks for your comments and adding to the discussion.
      The comparison to the Republican debate is interesting, but here there are no votes and there’s no competition.
      In many ways we are definitely on the same side on this issue philosophically, but just have different ideas about the risks involved and the best way to get to a better future for the stem cell field where patients can be helped in a way that maximizes possible benefit and lowers risks.
      Of course there will always be risks with any new medical treatment and especially one in an experimental kind of phase such as stem cells. This is also true of gold standard clinical trials as well as a strip mall stem cell clinic with a doc who doesn’t have any training in stem cells other than a weekend golf course “training”.
      The stem cell clinics generally do not use differentiated cells and they often do not follow rigorous standard protocols. Instead usually they directly inject stem cell drugs made from patient’s fat straight into the patient and it’s pretty much a shot in the dark. To be clear, the cells that are the focus of the discussion here are not HESCs or IPS cells.
      As a patient one should have freedom to make choices, but in our system an experimental medical product such a stem cell concoction needs some degree of evidence of safety and efficacy before it is used, and it needs regulation.
      All the best,

  5. “Predatory stem cell clinics are winning the war; what can we do?”

    Dear Paul,
    In my opinion, your blog can be used to advocate the victims to sue the clinics, “If more patients are injured or even die after getting questionable stem cell therapies”

  6. Paul Knoepflerr, it is not like FDA is at your beck and call and will suddenly move into action in response to your whimsical polls or each time you vent. I am sure you want some spark in your life and need scandalous stories to gossip. Why do you say clinics offering stem cell therapies milk patients out of millions and are laughing all the way to the bank? Are you not familiar with Regenexx, Stemedica, Celltex etc and their success stories? I am sure hundreds of patients went to other clinics and benefited from it. You think these clinics are predatory in their practice, or just years ahead of you perpetually academic-minded folks in translating technology to benefit patients. California funded 3 billion dollars in the same period, without even close to comparable success stories. Millions of dollars are handed to people, including yourself, who are forever researching, while patients are dying, despite the promise of stem cells we see all around in other countries. Patients and general public are smart enough to judge for themselves who else are also laughing all the way to the bank. Our citizens spend top dollars with hope that we will become the first in the world for cutting edge treatments and not to standby and applaud other countries moving ahead of us, as is surely happening now. The best argument in favor of those you support is to come up with demonstrable technology and treatments that work and capture the market, shouldn’t that be the winning argument that will please all patients? Why does it take you so long to bring to market the exact same technologies that Regenexx, Celltex etc have already brought? What do you guys lack in expertise or business acumen that you guys lag so far behind in market application. Are you saying that scientists who are funded by federal/state tax dollars are not using grant money to start for-profit companies to enrich themselves?? What is this predatory attitude that you are attributing to successful stem cell clinics? Can you define that a little better for the benefit of all the patients seeking stem cell therapies? Your only argument seems to be that legitimate clinical trials will not charge patients.

  7. Paul: Thank you for starting this very vigorous dialogue. Backing up a few years, stem cells were touted as the next cure for everything, in part because of California asking voters to approve the funding for same in California. Years have passed and people are frustrated, for after all the money spent, there are almost no approved treatments. The gap has been filled by entrepreneurs with mixed results. I believe that it would be great to have your institution sponsor actual dialogues among patients, FDA reps, academic stem cell researchers, physicians, and the entrepreneurs who are selling the “cures”. The more we understand the positions of each, the more profound the actual treatment can be.

  8. Evidence of safety and efficacy?
    How about 17 of 18 very very blind patients with AMD having their progression stopped.10 of 18 having life changing vision improvements with no safety issues except from unneeded immune suppression.
    6 dogs at Tufts cured with HeMSC’s of something like Lupus.Safe even in a different species for Pete’s sake.
    We also need to know where the new FDA commissioner stands.Is he on board with this new technology or with Big Pharma and their money machines.

    Thanks again,

  9. Paul – If you are truly being threatened with bodily harm and even murder, then it is hardly what I would consider a “challenge”. I assume you have contacted the proper authorities. Personally, I believe that in light of such threats, you are being very foolish to expose yourself to such danger on such a continued basis. Like I said, we all get that you don’t like the FDA ignoring you. We don’t need the message repeated so frequently. Quite frankly, it’s having little impact and certainly is not worth risking your life over.

    You of all people who continue to lecture endlessly on risk should take some of your own advice. No matter if we disagree, I certainly wish that no harm comes to you.

  10. Paul,

    I am a scientist myself and I feel like you are being a little short-sighted on this issue. The major health risks would be tumor formation or severe systemic inflammatory response of some sort, but these adult stem cells don’t form tumors and since they are autologous there is little/zero chance of systemic rejection. Adult stem cell (MSC) products exist (i.e. prochymal from Osiris) and have been tested in preliminary trials in humans as I’m sure you know – and that product is ALLOGENEIC. If there were safety concerns there would be people screaming bloody murder. From that viewpoint, while efficacy is not clearly known, it is not likely that these treatments are UNSAFE. There is also massive evidence of antinflammatory activity/immunomodulation, which seems to be the main goal with many of the conditions for which autologous adult stem cell treatment is being explored. I have gone back and forth on this issue, but I think there is a very clear line of logic suggesting the potential efficacy of these treatments and no real evidence to suggest they may be unsafe. Thus, people may be wasting money on something that won’t cure them, but if they are in pain and they have the money – and the police aren’t arresting the service provider (clinics) – it should be their choice. If the FDA is not cracking down on the clinics it may be for a reason…perhaps they don’t feel there is enough danger to disrupt the emergence of treatment modalities (and avenues to access them) that are potentially beneficial. There is an unofficial large scale clinical trial with eager volunteer participants taking place that would be impossible to facilitate with the current regulatory red tape. That is pure speculation, but there is a natural order to things, and this is all going on – with the FDA fully aware – and it continues to go on, so perhaps we should focus on educating people about the science…as you have done so admirably through your blog and books.

    Just my opinions…keep up the great work.

  11. My first question is:
    How can I differ between a serious and a non serious stem cell clinic?
    I believe there are already good ones.
    For example some time ago, we talked here about Dr. Chris Centeno. After this i have read many of his amazing publications and I think he is certainly a good and serious stem cell doctor.

    But there are many others and it is not possible for potential patients to judge them?

  12. Paul,

    Great post and this discussion is very engaging, despite the emotions being pretty high. With regards to the FDA role in regulating medicine, I am in full support of their efforts. Outside the context of medical regulation, the prospective patients could be taken advantage of by unethical “snake oil” salesmen.

    That being said, the biggest difference between a legitimate trial and the predatory stem cell clinics (in my opinion) is that a legit trial is done with a sponsor institute and a separate clinic. The clinic reports the results and does not benefit from its success so there is no conflict of interest. A predatory clinic does both, which helps to save them money and also generate income. But, here is the predatory part, they don’t report adverse effects (AE) if they don’t want to.

    Granted, the FDA is pretty slow and inefficient. If only there were some way to have these alternative clinics report AE’s. I recall a few years ago speaking with a young lady at the World Stem Cell Summit in San Diego. She was probably early 20’s and from Mexico. She looked like she should be gracing the cover of the swimsuit issue of sports illustrated. It turns out that she was a doctor and performed the surgeries on patients. I have no issue with beautiful Mexican doctors at all, my qualm is it seemed like she was more a PR person. And when I asked what type of cells she used, she said fat stem cells. I attempted more clarification, pre-adipocytes or fat derived MSC’s? She didn’t know what I meant so I asked where she got the cells. She said that she was the surgeon and had no idea where the cells came from, and she didn’t know what the term autologous meant. I asked how the patients were doing that she injected and she said great, all their ailments were gone. From arthritis to Alzheimer, she cured everything. I asked if there were any patients that didn’t fare so well, and she said no. Apparently, she had 100% efficacy and safety. I know, incredible right?!?!?!? Also, turns out that she only followed the patients for 2 weeks. Oh, and her results just so happen to not be published…

    Not saying every stem cell clinic operates this way, but controls must be in place to track AE’s. Of course, my opinion may be colored by the fact that I was never able to meet my grandmother because she died from a very expensive dose of Laetrile administered outside of the US…

  13. @ scientist with a sick mom – I think you made some balanced points regarding the right of patients to decide to spend their own money on treatments, but you based this in an apparently safe and efficacious therapeutic without giving context.

    For example, MSC may be safe when injected into the knee for support of regeneration of muscle or tendon damage, but are they safe if a clinic offers to inject them into your brain to treat Parkinson’s? That’s a completely different issue.

    “If there were safety concerns there would be people screaming bloody murder.”
    There are safety concerns and many, like Paul, are trying communicate this. Another example – allogeneic MSC are not immunogenic (hence no rejection) because they don’t express major histocompatibility antigens – but if they differentiate in your body they will become immunogenic, so patients are getting a bunch of loaded potentially immunogenic cells. I guess that’s why MSCs only work short-term as anti-inflammatory and supportive agents before they are cleared out or die – but if they are not cleared what then?

    I work in a biotech developing traditional anti-inflammatory drugs and one of the major concerns is that suppression of the immune system blocks surveillance and destruction of cancer cells. A side-effect of long term treatment with strong anti-inflammatory drugs is hence, cancer. If MSCs are anti-inflammatory did anyone do a cancer study to see if they prevent immune surveillance? No – not yet – and this is a 3-5 year preclinical study that must be done for any normal drug. This is a major concern and it seems the FDA is willing to let people be the lab rats – guess we’ll find out in 5 years.

  14. Jack I support partially what you are saying but I also think the person wanting treatment should also have the right to decide if to try or not. The main problem I see is for any of us who are looking for treatment of any ailment would like to have the availability to communicate with specialists in each the field. The only people we seem to be able to talk to are the marketing people and maybe later the doctor who will do the treatment. I want to get far better information about any treatment that I may want from someone who is working in the specific area I want treated.

    I am not good at putting thoughts into words but here goes. It’s just a idea. Regarding reporting of treatments, maybe one way to resolve would be that EVERY treatment done in any clinic must be reported to a stem cell body at time of treatment signed by both patient and doctor/clinic. Then a further written brief report of condition or outcome should be made by both patient and doctor each 12 months for a minimum of 3 years. If patient does not agree to do this then treatment will not go ahead. I fully realise it would be a lot of extra work for doctors/clinics but those that are willing to work under this sort of undertaking may actually find it helps in getting clients. I certainly don’t have any problem reporting on my condition whether better or worse as I think anyone who goes for stem cell treatment realises it is still experimental and any assistance each person treated can give will only help other people and maybe even one’s self at a later date.

    The other thing I really would like to see is a web site where those that have had stem cell treatment can go and blog with other people. It may be a person who has had similar treatments wishes to talk about results good or bad, or someone who would like to find out news about who are doing what sort of treatments and where. I certainly would like to talk to anyone who has had a heart attack and had stem cell heart treatment.

    • @David,
      On the organizations running the trials (and this would include stem cell-related work) that are listed are required to post data on results, but rarely do. They should also publish their results.

  15. David – A national registry has been suggested in the past. The FDA does have the capability (thank you digital age) to do this, but so far there has been no indication that it’s an idea that they would embrace. This would be especially helpful in the case of any adverse reactions.

  16. David you say a person wanting treatment should have the right to decide if to try or not. I don’t think anyone is proposing that they should not – but any government is bound to protect their citizens from danger, misinformation and scams. That is why clinical trials are performed and medicines approved by FDA and others.

    But at the other extreme, would you want that patients be conned out of their life savings for something that simply will not work according to current understanding of medicine and also carries a potential health hazard? I guess they have a right to be scammed and put in danger if they so choose.

    I am very exited by the potential of stem cell therapeutics, but they must undergo controlled clinical trials in order to be able to give the right patients the right therapy – you would like “to communicate with specialists in each field” but these guys also need to have the right info and currently research is still ongoing. As a drug developer, the analogy for me is that we have a compound that works a bit in rats and now we make pills and market them for Parkinson’s. That’s illegal and for good reasons. Research and clinical trials must be completed to obtain the right info.

    Those dubious fat stem cell clinics that have never run a controlled trial and have no intention of doing so are selling those untested pills for money. While there are some illnesses that have obviously benefited from MSC therapies and data in clinical trials defines how, how much, how long, and what side-effects to expect, it is not a simple extrapolation to take the same MSCs and put them in the brain and expect cures. It would be like saying insulin injections work in diabietics so it should work for Parkinson’s or ALS. Crazy right? Well that’s what is going on in some clinics.

  17. Jack I agree and understand some of your comments of potential problems but I still feel that people should have the right, freedom and control to decide when they’re making their healthcare decisions. It is the reporting of treatments or health care given which I see as the problem.

    Yes the government has a right to protect but it should be by offering information not closing the door on everything. Overprotecting people does not work as it makes them naive when it came to assessing risk and it promotes a risk-averse society. Also a many people hide behind these overprotected laws and don’t venture outside the box for fear of being sued. We need risk takers, entrepreneurs, scientists, researchers and guinea pigs ect. If we had stopped these people over the last centuries with all the laws around today, where would we be?

    As reported in the Daily mail in August 2008 relating to over protection of children. “Half of children aged seven to 12 have been stopped from climbing trees, one in five are forbidden to play conkers and 17 per cent are not even allowed to play tag, researchers found.

    While 70 per cent of parents said their own greatest childhood adventures were among rivers, trees and woods, only 29 per cent of today’s children said their favourite play experiences were outdoors.” This is what is and will continue to happen in health and medicine and force a very narrow mind set from researches and patients.

    I totally agree with Barbara’s comments re a national registry. The FDA would certainly have the capability and this idea should be embrace. It certainly would be helpful in the case of any adverse reactions and it may also help in seeing positive outcomes that have not shown up in any trials.

    Having a FDA register of treatments and outcomes that is accessible for anyone seeking treatments may allow people to evaluate if it is worth taking a treatment being offered. It is then their decision relating to risk, chances of improvement and money.

  18. Paul, If organizations running trials are supposed to do what you posted, then WHY aren’t they forced to or lose their licenses?

  19. David – people do “have the right to decide when making healthcare decisions” – they choose from tested and regulated medicines. But governments cannot allow citizens to be exposed to unproven therapies with unknown health risks – can you imagine the public outcry there will be when the first child is killed by an unregulated fat stem cell therapy gone wrong? People will then be blogging about why the government doesn’t do anything to protect them from medical charlatans.

    Btw – children have already died in these clinics in other countries (see, X-Cell Center controversy; Nature 2010 24;465, Strange lesions after stem-cell therapy). There are about 30 such reports of deaths after unregulated stem cell therapies – people just don’t blog about them so much.

    But if people want to play lab rat, risk their lives and pay for the pleasure on top, they can visit these dubious fat stem cell clinics, offering cures for Alzheimer’s and Parkinson’s, all over the world. In my opinion none of them will receive any real medical benefit and unfortunately, they will also not contribute to the knowledge base as these clinics do not report results (for obvious reasons). The only problem I have with this scenario is that the patients are clinging to a hope that cannot be fulfilled and are being exploited for it. If they still agree, well OK.

    I agree completely with you that, at this point where real therapies are still in development, the issue for patients is where to get the right information (definitely not the Daily Mail ;-)). But how can any non-clinician interpret clinical results? They are never black and white and are always presented in a positive light where possible. Whatever you think of the FDA it is only their approval to market a product that gives us an idea if the drug works and is safe.

  20. Richie – The International Society for Stem Cell Research (ISSCR) has published a document, which exactly addresses your question: What should a patient in a serious situation do?

    Part 10. “What should I look for if I am considering a stem cell therapy?” and part 11. “What should I be cautious about if I am considering a stem cell therapy?” are of particular relevance to the issues most often discussed in this blog.

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  22. Patients feel like pawns and lab rats for those who stand to profit and rightly so. There is little doubt why patients seek stem cell treatment outside of clinical trials. They are trying to improve or save their lives and don’t have decades to wait. Here is a sad commentary on some patients who are forced to beg for their lives while battling the bureaucracy.

  23. @ Barbara
    Let’s have some balance, please.
    Patients electing to pursue these kinds of experimental treatments are also absolutely lab rats, just in a less controlled setting. Your position as an advocate is sympathetic, but statements like that reek of ‘woe is me’. Also, they are not begging for their lives, they are seeking an opportunity to pursue a treatment that may improve their quality of life – but the outcome can’t be known. Your statement is a fallacy because it implies that there is an option that will 100% save their life that they are being denied. That is false, inflammatory and outright dangerous to readers that don’t have the intellectual defenses to think for themselves. Please continue to push for advancement of stem cell therapies for patients, but stop the propaganda, it’s damaging.

  24. @scientist with a sick mom I’m not just an advocate, I’m a patient with a progressive disease for which there is presently no cure. I have had many quality of life improvements from stem cell therapy. I doubt I would be alive today if not for a couple of innovative doctors that have helped me. Frankly, it is tiresome dealing with such a narrow minded group of “intellectuals” who believe that they know what is best for those of us who are sick.

    I think it is disingenuous of you to post under something other than your real identity and then call me out. It makes it impossible to know what your conflicts of interest may be. And shame on you for claiming that patients are too stupid (not having the intellectual defenses as you put it) to think for themselves.

  25. Mr. Knoepfler’s blog definitely has a way of bringing opposing views to light. We as stem cell recipients/patients definitely have a different view of what the FDA’s roll should be in all of this. But @Barbara is right, patients do feel extremely frustrated in the seemingly endless bureaucratic red tape going on in this country regarding cell therapy. There has also been endless dialogue with paternalistic attitudes that patients can’t make medical decisions for themselves. This is far from reality. I for one went looking for an alternative. I can’t think of a single person I know who would just sit back quietly and say “OK this is it for me!” Patients speak to other patients about doctors and clinics. We share the good, the not so good and everything in-between. We now know what clinics are getting good results and what stem cell doctors are amazing. Unfortunately this is all done as a medical tourist in another country. No one wants unsafe treatment, but maybe the FDA is regulating the wrong things?

    • @Jennifer and Barbara,
      I know we do not see eye-to-eye on some things, but I want to thank you for your comments. They definitely add a great deal to the discussion.

  26. You need to realize there are dying patients, and yes, they may be desperate and willing to take their chances with experimental treatments. However, your conclusion on how desperate patients are gullible and dismissive on facts is not entirely true. It may be the case in the research world, but not in the medical procedure world. Stem clinics like any other medical treatment has an evolutionary progression too reach its pinnacle protocols and procedures. Hundreds of medical treatments have had their uphill battles, and yes, terminally ill patients have expired like the countless heart transplants in late 60s and early 70s, and this is just one example of a medical procedure. Those that lose their lives are not lost in vain, PK. They are pioneers that make wave for future generations with medical innovations that can save millions. Here is where the ideological differences lie between academic research for chemical drugs and medical procedures. Needless to say, stem cell treatments in comparison to hundreds of other more venturesome treatments are in diapers in comparison to the much risker procedures like heart transplants, liver transplants, brain surgery, and host of other treatments. Just let the doctors handle it, they’ve done a great job so far.

  27. Like everyone I do not know the answers but I do know that many people have died or been harmed by drugs that have supposedly been tested and approved by the FDA. The FDA are not perfect by any means and if we seek treatment with drugs we rely on the doctors who have been filled in with the entire bumph from a drug company as to how good and safe the particular drug is. Drugs have killed many people too!! How many people have been killed by stem cell treatment?

    I like a post that was put forward by Bob on another site where he posted. “If you look closely at what the FDA does you’ll see it “protects” American companies interests causing American consumers to pay twice what all other countries consumers pay, under the guise of “safety”.
    In pharmaceuticals Americans pay twice the prices of all other countries “to keep us safe”. I believe this is true.

    Another post from a person via goes onto say; – “Medications approved by the United States Food and Drug Administration result in 100,000 deaths every year from what the federal agency describes as “Adverse Drug Reactions”, or ADRs. Worse, over 2 million Americans suffer non-deadly adverse reactions to drugs every year that the FDA has approved “safe”. ADRs refer to negative reactions that Americans suffer from taking drugs as directed by their doctor or the drug’s manufacturer. These cases DO NOT include overdoses or drug abuse.” Why are stem cell treatments being picked out when many people are dying due to drugs?

    I believe that the play-it-safe attitude in stem cell research and clinics –even at the expense of human lives–is slowing the potential of helping many people to improve their lives. Why do we have to wait till we are on the last breath before we may be accepted for an approved trial? At that time it is a life or death situation and you are totally in the hands of doctors and hospitals plus if you are that ill does this help in recovery. I would rather do my own research by talking to other patients, doctors, researchers and anyone else I can find so I can decide if I wish to take the risk of a new treatment while I am not desperate and fully aware of possible outcomes.

    I feel people should have the option to decide on any stem cell treatment so long as all metal and physical evaluation have been researched, relayed to patient and reported on. I certainly don’t see many of the stem cell treatments being offered today from reputable clinics fall in the life threatening area.

  28. Paul,

    What you are witnessing is the evolution of a parallel system of healthcare.

    Plain and simple: people are very dismayed by the fact that they can become a “no option” patient in the year 2015, where global spending on healthcare is closing in on $7 trillion, $1 trillion spent on pharmaceutical products alone, with $200 billion of new R&D annually.

    And the cures are where? Not to be found via traditional channels

    On top of that, the safety argument has been obliterated by the systems own actions.

    Today there are literally hundreds of FDA approved products that can prolong QT and/or Cause Torsades De Pointes resulting in sudden cardiac death; which are IARC Group 1 and 2 carcinogens; which have significant ”black boxed” SAE warnings; not to mention the 2+ million ADEs (100K+ fatalities annually in U.S. alone) which come from products that have gone through decades of human testing.

    Animal models remain poorly predictive for humans, yet remain a mandatory cornerstone behind years and millions of dollars of early drug development activities. Penicillin kills guinea pigs and produces birth defects in rats, aspirin is poisonous to cats, cancer has been “cured in mice” thousands of times, and dozens of drugs found safe in animals are later withdrawn from market due to adverse drug events in humans.

    Additionally, we continue to spend billions of dollars on traditional “gold standard”, population level clinical studies, despite the fact that they use definitions of disease that are excessively inclusive (based upon disease characterizations from literally decades ago), while at the same time are excessively exclusive of major segments of the patient populace.

    What people have begun to understand is that it is pretty much all a big gamble, any way you slice it – so why not become an “n-of-1”?

    One only needs to survey the landscape where such dynamics exist in “stealth mode” in current society to see where these concepts are already permeating our lives.

    From a therapeutic perspective, current FDA initiatives regarding expanded access, off-label use, “animal rule only” development, and botanical drugs, as well as their public written position on personal importation, all highlight examples of various degrees of clinical, “let the patient beware” freedom that the agency is quietly willing to grant subjects today who seek out such products or who engage in related studies.

    Further afield from pharmaceuticals, markets such as dietary supplements, cosmetics, processed ingredient foods/beverages, tobacco, legalized marijuana, and pesticide/herbicide usage, all technically represent large, uncontrolled clinical experiments on the general public, that we all are quite willing to accept today as personal choices.

    It is a new era

  29. Ira – If I could give you several thumbs up I would. You have made some excellent observations bringing new perspective to this conversation. I believe you have hit the nail on the head.

  30. Barbara I more than 100% agree in your comments if that was possible. There are many drugs that have been approved that either kill or maim but also have saved many lives. Why is stem cell so different?

    In reply to Jack post on September 20 re children I agree as they do not have the ability to decide for them selves. Any agreement to take any risky treatment no matter what needs to be by an adult who has all metal functions and awareness of the potential risk. For many of us who are willing to try are over 30 years of age and we should be able to decide for ourselves.

  31. @Ira – you’re talking about an era that we already had – it was the medieval era.

    “And the cures are where? Not to be found via traditional channels” – Unfortunately not yet – but they are also not to be found in unproven, uncontrolled, non-powered trials. Your argument for the n=1 patient is that there are already drugs with adverse effects out there – but that doesn’t make the n=1 patient any better off – it exposes them to even greater risk.

    I have nothing against folks spending their savings on unproven therapies if they can afford it, but for others to be sold lies because they are vulnerable is unacceptable – or is this the era you look forward to?

  32. But if there is no other chance … ?

    But please consider, there are also stem cell patients, who have not a big choice. What would you do if a member of your family has suffered a serious stroke?
    In this situation I would think about a stem cell therapy, although nobody knows if this therapy could work. Until today there are only a few case reports (see for example reports about the amazing recovery of Gordie Howe and Bart Starr on this blog). I am very sceptic, but this therapy is maybe the only chance for a good recovery…
    By the way the results of the first study concerning stroke treatment (by stemedica, who treated Gordie Howe) will come in May 2016. Hope they will be successful.

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