Popping the bubble of stem cell populism

popping bubble populism
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What happens if we mix stem cells with populism?

From a populist view of stem cells, everyday patients should be able to do nearly anything they want with stem cells without any governmental interference or excessive expense. Even stem cells not proven to be safe or effective. This can sound like an appealing idea to patients looking for hope and also to some companies looking for profits. Stem cell populism poses serious questions and risks too.

What exactly is “populism”? The Internet defines it these ways:

“support for the concerns of ordinary people.

the quality of appealing to or being aimed at ordinary people.”

In what we might call a stem cell populism worldview, stem cells should be available to the everyday folks across the U.S. and the world. It’s a simplistic notion today since for the most part, stem cell therapies haven’t yet been proven safe and effective other than in a few narrow cases such as bone marrow/hematopoietic transplants. Would wider availability of stem cells right now help people or potentially be more likely to hurt them (health-wise and economically)?

At this point, the former is much more likely and there would be concrete harms. To be clear, at some point with future proven stem cells therapies, I believe that such safe and effective treatments should be widely available and not at an exorbitant cost (insurance coverage of stem cells is and will continue to be an important area to discuss including related to cost as well), but that’s not the stem cell populism of 2018.

Some direct-to-consumer stem cell firms that market unproven and non-FDA approved stem cell “treatments” invoke a kind of stem cell populism to draw customers in the door. Certain clinics repeat catch phrases essentially as advertising like “you should be able to use your own cells however you want” and “you have a right to your cells.” In fact, as I’ve written in the past (see, “Our bodies, not our cells?”), our rights to our own biologic materials including our cells are much more limited than most people think.

Often times once a clinic or hospital has your cells, it is unclear who has ownership. More broadly, we don’t have a universal right to use biological products made from our bodies in any way we want. Such a right does not exist in any federal law that I know of nor in the Constitution, etc. So, no, there isn’t a clear inherent right to use (or even own) one’s stem cells that I know of, and that’s especially true if the stem cells have been turned into a drug product by processing or by use in a way unrelated to the intrinsic nature of the tissue from which the cells were isolated (non-homologous use).

Stem cell populism is also related to the Right-To-Try movement, which seeks much broader patient access to unproven drug products than is currently available in most cases, but some promoters of Right-To-Try comes off as being anti-FDA as well. For example, the current Right-To-Try legislation at the federal level has some provisions that would interfere with the FDA’s ability to oversee this arena. It’s also important to note that the FDA already has an expanded access (aka “compassionate use”) program that is streamlined and approves nearly 100% of applications with relatively much less paperwork and time required than in the past.

Notably, from a practical perspective for stem cells, I’m not aware of the various state level Right-To-Try laws having led to proven beneficial outcomes and they are almost never utilized. For some groups like the Goldwater Institute, it’s reasonable to ask the question the following: could Right-To-Try and perhaps also stem cell populism of a sort be more of a philosophical or ideological goal than anything else?

My hope is that in the next 10 years we’ll have a half dozen or so approved, proven new stem cell therapies. If that hopeful vision becomes a reality, again I also hope (and will work to make it a reality if what way I can via advocacy) that they are not so expensive as to fail to be widely available to patients in need. But I believe that the stem cell populism of today isn’t going to help people. Instead it is more likely to make profits for various firms or be used as a political device. In that sense now, it is often a bubble instead of a real thing that can help people.

Some might argue that one type of stem cell populism is already the reality today with ubiquitous stem cell clinics operating across the U.S. and the world without governmental approvals. Are they right?

Note: the idea of stem cell populism came up on Twitter last year, which is what sparked this post, but I can’t find the original twitter conversation.

11 thoughts on “Popping the bubble of stem cell populism”

  1. Corrrection about my previous innacurate post. The 16 year old cardiac patients name was Dimitri Bonnville. His father is Craig Bonnville. The family of Dimitri Bonnville in 2005 or thereabouts was in the process of suing the William Beaumont Hospital for some kind of medical negligence. According to an article in The Scientist. https://www.the-scientist.com/?articles.view/articleNo/16419/title/Use-stem-cells–get-sued/
    Apparently as of about 2005, Dimitri Bonnville’s heart was not doing so well and according to his step mother was operating at about “a little over a third” of its’ capacity despite the stem cell transplant at William Beaumont. The word from the family’s attorney was that Dimitri was in need of a heart transplant.
    That’s all I have. I really don’t know how things turned out for Dimitri Bonnville since that time. My apologies to Dr. Knoepfler and the blog community.

  2. Fat cells and the blood stream. Good point. However, that seems a bit different than extracting and expanding adult stem cells from adipose, blood or bone marrow tissue. Upon doing so later to be utilized for injection/infusion particular, but not limited to, orthopedic conditions. (For instance, read about Craig Bonneville’s cardiac procedure below) I’ve successfully had platelet rich plasma for my knees and would more than welcome the chance for use of my own stem cells especially if they were cultured to expansion. I’ve read in Forbes Magazine about computer entrepreneur Michael Phelan who has experienced quite a bit of success following several infusions of his own expanded (fat) stem cells relative to his MS in, of all places, Panama. Though not cured, it appears pretty likely that he experienced significantly greater improvement regarding Multiple Sclerosis symptoms than he did with previous pharmaceutical therapies. Anecdotal? Placebo? All I know is that data also can be interpreted any number of ways and presented according to bias particularly given expertise in the field of statistics. Since the FDA has a myriad of confusing and arbitrary sounding regulations which claim that stem cell expansion is tantamount to creating a drug, regenerative clinics in the U.S. are forbidden from engaging this procedure and evolving within that particular practice of medicine. The FDA has effectively put the brakes on this though they were never mandated in the first place to regulate the practice of medicine. This is an agency that,as far as public safety is concerned, just does not (to me) have a lot of credibility. In the 1960’s the FDA began to crack down on drug safety and efficacy in light of the thalidomide disaster. They did this in part by instituting new types of clinical trials. Sounds like a good idea. Right? The problem is that cancer immuno-therapy drugs (bacterial toxins) got caught up in this dragnet and were (with the help of Parke Davis) removed from the market. The FDA decided that bacterial toxins which were used to boost the immune system and fight off cancers despite having been on the market for 70 years (since the 1890’s) were now considered to be a “new drug.” Consequently, they would have to undergo enhanced rigorous clinical trials. (Thank goodness the FDA left aspirin alone) As though 70 years on the market was not time enough time to show safety and efficacy. Parke Davis decided that these new enhanced clinical trials were not in their financial best interest. The drugs were referred to as “Coley’s Toxins” after the surgical oncologist Dr. William Coley who lived from about the 1860’s until the 1930’s. A “New Drug” to the FDA sounds about as believable (to me) as labeling our autologous stem cells “drugs”. The idea that the FDA did this for the safety of the American People sounds particularly condescending especially in light of the fact that Parke Davis clearly had a financial interest at stake in taking their bacterial drugs off of the market. Did anybody ask the patients? (A rhetorical question) By the way, bacterial drugs could not be patented which is where the real money is for big pharma clearly demonstrating that safety and efficacy are less meaningful to the business of medicine than generating cash.

    You can read about Dr. Herbert Ley sometime. A former commissioner of the FDA during the Johnson administration and the enormous pressure he received from drug companies to allow their products onto the market. Things have not gotten any better since that time especially after giving the thumbs up to big pharma (during the Clinton years) to begin increased levels of funding the FDA’s annual budget. This effectively gave the private sector even greater leverage over federal regulatory agencies than before. I’m sure you know about the Prescription Drug User Fee Act. (PDUFA)

    I’m a progressive democrat, so I do like the idea of an FDA. However I want an FDA that is accountable to the public and not just by words printed on a mission statement. I am very uncomfortable when their Commissioners are hand picked political appointees (since Reagan) with clear financial conflicts of interest that truly place the safety of the American People at risk. Relatively speaking, regenerative clinic malpractices are almost nothing by comparison to the number of injuries and deaths that occur each year with FDA approved drugs as well as within the standard practice of accepted medicine and surgery. The FDA is an agency that still clings to the mythology of refer madness and refuses to reschedule cannabis and LSD despite these substances tremendous potential in treating traumatized war veterans. I am not telling you anything you don’t already know, Dr. Loring.

    Consider the case of a 16 year old boy (Craig Bonneville) who was accidentally shot in the heart with a rusty nail in Michigan in the early part of this 21st century. The boy began suffering heart attacks. Michigan Doctors began treating the young man by utilizing his own blood stem cells introduced by catheter into his heart. By most accounts this procedure was a success and he is now a healthy young adult. But, the FDA admonished the Doctors who treated the young man “not to conduct any similar procedures” and with their bureaucracy effectively put the brakes on this small Michigan hospital relative to their desire to conduct clinical trials. I’m sure that the FDA with their myriad of CFR’s, rules, regulations, technicalities and armies of attorneys can find some way of claiming that they were only acting in the best interests of the public. But given their history I believe it is more likely the following. They were trying to insert themselves into a ground breaking medical procedure and reacted as gate keepers often times do when success takes place without their blessing. (http://genomenewsnetwork.org/articles/11_03/heart_ste_cells.shtml) This happened all the way back in 2003….15 years ago! That’s an entire lifetime for some unfortunate souls. By any reasonable metric, this stem cell procedure ought to have been thoroughly researched & then cleared of the highest of bureaucratic walls by now. Given the boy’s success, this infusion of stem cells into the heart should have naturally evolved by Cardiac Surgeons and Cardiology Physicians without interference from the FDA. It should have become the standard practice of medicine; not simply something restricted to and then dragged out through clinical trials….15 years later!

    And yes, I can understand why the FDA classifies stem cells as drugs, And it has nothing to do with safety or efficacy or arbitrary standards like homologous use and minimal manipulation. I’ve come to believe that the FDA “Powers that Be” behave in similar ways to that of politicians who respond first and foremost to their donor base at the expense of the majority of the people. Sure. The FDA approve drugs all the time, provided you can afford the exorbitant prices needed to file for an IND & Pre-Market Approval which is itself a bureaucratic nightmare particularly if you are a small institution like this Michigan based hospital. When Big Pharma pay the FDA to then regulate their drugs, that seems to me a kind of shake down. Except such costs are pennies to the revolving door industries that are Pfizer, Merck, Glaxo Smith Klein, Johnson and Johnson, Bayer, Novartis and all the other members of the pharmaceutical club for growth. But, certainly not pennies to a small Michigan Hospital. And yet no action was taken relative to lessening the bureaucratic paperwork for these inventive Michigan Doctors who very likely saved Craig Bonneville’s life…(15 YEARS ago!!!) No real work relative to implementing sliding scales for this small Michigan hospitals’ ability to pay the FDA for an IND/Premarket Approval Process was ever taken to my knowledge. It’s “pay to play” no matter how small you are.
    Predictably, I’ve seen comments from Dr. Knoepfler rushing to the defense of this “stem cells are drugs” rhetoric insisting that hospitals & clinics, no matter how small, should have equal FDA inspection standards as that for much larger pharmaceutical companies. ( http://blogs.harvard.edu/billofhealth/2013/06/02/our-bodies-our-cells-fda-regulation-of-autologous-adult-stem-cell-therapies/) This one size fits all philosophy makes certain scientists seem to me not very scientific at all but rather dogmatic and inflexible. Yet there is consistent refrain on this blog with references to terms like “Vulnerable Patients”, “Dubious Procedures” “Unproven Therapies” and (my personal favorite ) “Predatory Clinics” . The last term seems a bit rich when I consider that the FDA employ armed agents who seem to have a history of abuse. (https://www.reuters.com/investigates/special-report/usa-fda-cases/) Who are is the real predators here? There is very little to no mention on Dr. Knoepfler’s part about the high cost of regenerative medicine relative to “predatory” insurance firms refusal to pay unless the FDA gives them the green light to do so. (Read…Standard of Care). Again. Who are the real predators here? It seems like yet more collusion between the private and public sectors where the government becomes effectively the dog being wagged by the tail of moneyed interests. Some call such arrangements “private public partnerships”.
    Finally, well before Dr. Chris Centeno and Regenexx sciences lost in Federal Court to the FDA’s notion that stem cells are drugs, it was predicted that such would happen by Attorneys Mary Ann Chirba and Stephanie Garfield. But, not on the basis of whether the FDA had it right in calling autologous stem cells drugs. Rather on the basis of the FDA already occupying a position of power and influence within the Federal Government. Really a very shameful decision in a country when the less powerful lose pretty much on the basis that “might makes right.”

  3. Douglas-
    You can understand this – I don’t expect you to know how to reprogram cells, but I do expect you to know that reprogramming skin or blood cells produces induced pluripotent stem cells, which can give rise to every cell type in the body.

    I expect you to know that an entirely different kind of stem cells exist in our bodies for the purpose of repairing damage, and many, but not all, organs have stem cells that are specific to that organ. The clinics that take cells from fat and inject them into people’s bloodstreams know that fat cells don’t belong in the blood, and they don’t stay in the body beyond a day or so. They do believe that they can make money if they claim that their procedures can cure disease.

    I think you can understand why the FDA classifies these cells as drugs. It’s not impossible to get a drug approved by the FDA. Drugs are approved all the time – if one of these clinics shows that the cells they are using are safe and effective for some specific purpose, the FDA will approve them.

  4. There is another point of view that at times I see presented on this very blog. This article, at least to me, exemplifies that perspective. I don’t call it stem cell populism but rather stem cell aristocracy or perhaps stem cell elitism. To me this is the condescending notion that we, the unwashed masses, just don’t have the scientific, technical or legal knowledge or background to decide what is in our own best healthcare interests. For that we have to trust and consult the experts, like the scientists and rely on their data, their number crunching and their point of view to find the way forward. The internet is just too dangerous a place. Don’t trust it! Don’t trust yourselves! For your views will always be far too simplistic and ideal. They will invariably fall short when compared to the practical and very rigorous world of the expert and the scientist. Trust these folks who work in laboratories and take the daunting course work in high school, college, graduate, Medical, Dental, Pharmaceutical and Veterinary school. They know because they have the ability, the credentials and they are working in our best interests. When they, the scientists, the experts and others tell us that adult stem cell therapies are not yet ready for prime time and could even be dangerous, believe them because they are the experts. They are paid to know. They have no financial or any other type of ax to grind and the idea that they do is simply deep state conspiracy theory. Our only hope is in waiting for them to give us the green light even if that day is decades and billions of dollars well into the future. That’s just the nature of science my friends. It has always been that way and always will be. And many will have to perish or suffer along the way. But, time is never on the side of the good scientist or suffering patient.
    Stem cells are drugs. Why? Because the venerable FDA says that they are. This great agency of the people have at their disposal all manner of documentation, rules, draft guidance regulations, CFR’s and federal court decisions to back that assertion and many others up including that your body parts do no belong to you. In a similar sense, to The Supreme Court, corporations are persons and money is speech as well. But, don’t bother to read about it because it is just too complicated for you commoners to understand. Take the experts and their corresponding institutional words for it. Don’t check under the hood!! By default, the experts’ and agency decisions, whether public or private in our free country will, in the long run, always be in the best interests of the people……even-if-it-does-not-seem-that-way!

  5. Cathy raises the key point: That approved stem cell treatments are not available for any but a tiny portion of our afflictions. Much as I would like to blame the religious right (and the religious left), I can’t. In my experience, it’s damned difficult to make a scientific discovery and often grueling to figure out a solution to some problem or other. Way back around 1910 Landau proposed four mathematical problems that could be simply stated. They are still unsolved. In science, as in mathematics, discoveries come when they come. Sometimes they don’t.

    I would add one thing. Many of the accepted medical treatments of today have little evidence to back them up. So I take a different view from Paul. More often than your garden-variety surgeon will admit, he does more harm than good. Finally some are heeding evidence:
    But it’s taken a disgracefully long time. The first publication on the issue was published in The Journal of Bone and Joint Surgery by a guy called Fairbank, way back in 1948. I have a pdf copy on file but I can’t remember from where I snagged it off the web.

    There are circumstances in which a relatively lower risk autologous stem cell treatment might be a better option even if it’s efficacy is not yet “proven”. Indeed, invasive surgery would likely fail if your stem cells didn’t fix what the surgeon has left behind!

    So, there are no easy paths; not for the scientist, not for the MD, and sure as hell not for the patient. Everything must be studied and judged upon it’s relative merit.

  6. Populism is also described on the internet as anti-intellectual, or a political movement that offers unorthodox solutions. The patients I know who’ve gone outside the box to find stem cell solutions to death and disability may seem completely unorthodox to someone who’s not chronically or terminally ill. What choice do patients really have when there are no approved drugs left to try? The choices that we as ‘no option’ patients have made are intelligent, well researched, brave, innovative, and will soon carry the full weight of the law behind them here in Texas. PFSC’s has been at the ‘steakhosders’ table in 2 separate meetings with the Texas Medical Board, and we are very excited to say our Texas doctors and legislators are all on the same page. We all want safe, effective and legal adult stem cell treatments. Education has been key in getting to this point. The TMB was able to bring all interested parties to the table, (scientists, doctors, legislators, industry insiders, advocates, patients, lawyers, lawyers, and more lawyers HA!) The TMB took input from everyone. PFSC’s agrees, not all stem cell providers are legit. Some are selling patients on false claims, such as amnion products advertised as ‘stem cell,’ treatments, or SVF as a systemic treatment for everything. These types of treatments are surely unlawful as deemed drugs by FDA. We are already seeing some doctors in the media claiming they are treating patients now because of HB810 when that is absolutely not possible. The bill is not fully implemented yet. We see clearly what we will be up against. We hope with our Texas model in place to weed out these types of providers allowing for legitimate adult stem cell treatments and providers to finally make their way to chronically ill patients without having to leave the country. We will tackle insurance coverage next, but our primary goal now is accessibility.

    Dr. Delpassand, founder and medical director of Houston-based Excel Diagnostics & Nuclear Oncology Center, has been using Right To Try successfully.

    You call it populism and I can see your point, but sick and dying patients call this hope, at least down here in Texas.

    Jennifer Ziegler
    Founding Member PFSC

    1. Hi Jennifer,
      Thanks for your comment and perspectives. We don’t see things eye to eye on a lot of fronts, but I do agree with some key parts of your comment. Also, I find your comments very helpful in understanding where things are at in Texas and more broadly. If a particular stem cell treatment is ultimately proven safe and effective with good, properly controlled data, I’m all for it being available. Plus, I do not want it to be so expensive and/or not covered by insurance that patients cannot access it. But where we are at today, most folks selling stem cells just frankly don’t have the data to back up what they are selling. I also philosophically don’t believe in charging patients to receive experimental therapies, whether it is stem cell-based or a chemical. It’s sadly ironic that some places requiring big money like $10,000 or more for an unproven stem cell therapy, also invoke a kind of populist mantra that patients should have access to their cells as a fundamental right! But the $10K price tag is a barrier to access for people.

  7. Honestly? The reason that all of these stem cell clinics exist in the first place is that safe, effective, FDA-approved stem cell treatments should already be available by now, and they are not. The reason they’re not is that embryonic stem cell research has constantly been held back by federal funding being banned over and over again– and then, once the ban was lifted, court cases would immediately be filed by groups backed by the “religious” right. If this had not happened, we’d have at least some of these treatments right now, and we’d have a much better idea of what is realistic and possible. We have been held back by cruelty and ignorance masquerading as religion and politics. I’m sorry that scientists have had to deal with this, but it’s been the reality.

  8. I’m grateful to you for these blogs. However, I stand just slightly on the other side of the fence on these issues. I use these blogs as my own personal source for hearing and understanding another perspective. Your expertise does not escape me.

    My opinion is some risk is simply inevitable and necessary. That’s just life, and that’s how progress is made. To me, it’s obvious those in a try or die situation should have the right to attempt these early versions of treatments. I’m satisfied with the FDA’s version of this even if it isn’t being used much yet. From my perspective, little of the general public really knows what’s happening in this field, nor the potential consequences good and bad. Everyone is understandably wrapped up with the latest Trump news or the latest school shooting.

    Yes, let’s minimize the risks, but to a balanced degree. Let’s get there sooner than later when it means saving lives. When taking my meds has risks ranging from dizziness to death, I am to accept slow progress with a completely superior method of dealing with health care that actually prevents sickness instead of just responding to it?

    Let’s also not regulate our way out of the competition worldwide. There are serious consequences to the economy and our ability as a nation to keep up with those like China where they are moving so much faster with less regulations. What happens when China as a dictatorship mandates treatments that lower the economic burden of the countries health costs by trillions of dollars, while America is still playing it extra safe? I guess let’s hope for cooperation and open research papers. Should we count on China sharing their findings? I’m not so sure. From what I hear, we in the states are losing scientists in all kinds of fields to other countries because the action is so much hotter elsewhere.

    I’m reminded almost daily that this field is still in it’s early stages. At the same time there is technological research in progress leading the world toward changes like we’ve never seen before. Why aren’t people talking about the amazingly positive things going on? We are living in an unprecedented time, and I do not believe I’ve been coerced into believing this due to the hype out there. I can tell the difference and I think most people can as well.

    As mentioned, I read these blogs to maintain a balanced perspective. Having said that I do wish you’d throw in more things like, “Here’s a list of what’s great coming from the stem cell world,” or “here’s a significant breakthrough you should know about and this is what it could mean for you.” It seems there are more and more breakthrough’s all the time, and it’s next to impossible to sift through all the information online to get an idea of what’s important, what’s just hype, or how close we are to achieving this or that. You, as opposed to the majority of youtube videos for example, are a direct, expert resource who has the power to inform. I follow websites like CIRM, SENS Research Foundation, Bioviva Sciences, and Sierra Sciences, but honestly not a lot of new news really comes from those sources.

    Sincerely and with the utmost respect,


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