Is “snake oil” too harsh a term for some of what is sold at some of the worst stem cell clinics?
Is the phrase “stem cell clinics” itself accurate and useful in a broad sense?
When we read or write the phrase “stem cell clinics”, most people generally know what we’re talking about, but it is not a very precise use of language, especially these days with so many different clinics out there, and there is a lot of room for error. There are many kinds of stem cell clinics too so they don’t easily fit together under the umbrella of just one term.
Taken together, these naming issues represent a challenge.
A “stem cell clinic” might on one end of the spectrum be fully compliant and legit. It could be a CIRM-funded alpha stem cell clinic that is rigorous and follows FDA regs very careful or could be part of an institution that provides fully validated hematopoietic stem cell transplants related to blood cancers.
However, in the middle and on the other end of the spectrum a “stem cell clinic” would generally be a very different thing. It might infuse patients with any of a number of things loosely affiliated with “stem cells”: most commonly some gmish of cells extracted from your fat and processed supposedly to treat a whole medical dictionary’s worth of ailments. No FDA approvals at play here. Perhaps it’s a place that injects even animal stem cells or a non-living reconstituted powder extract from some baby’s amnion supposedly to “treat” aging or anything from head to toe…or it could just saline marketed as “stem cells”… or many other things.
In theory, we need a better name or names for these entities than just “stem cell clinics,” but it’s a challenge.
Over the years, some of us have tried out different phrases or nomenclatures for what might accurately but clunkily be referred to as “for-profit, direct-to-consumer, unproven stem cell clinics that lack FDA (or a similar agency, abroad) approvals.” While these various phrases we use more commonly have been shorter than my super long one above, they haven’t really seemed to fit the bill that much better than the long one and generally are less precise.
Here are some examples of phrases used in the arena and that I myself have used. Insert “stem cell” before “clinics” in each case below:
- “Dubious clinics.” This isn’t ideal because in many cases clinics aren’t “dubious.” For quite a few it is 100% clear that they are running afoul of FDA regs and have other major issues.
- “For-profit clinics.” Most clinics are focused on making money off of patients. However, some people have rightly pointed out that many hospitals, biotechs, etc. are for-profits too. Still, one common feature of “stem cell clinics” is that they charge patients, whereas the clear majority of traditional clinical trials do not charge participants huge fees.
- “Direct-to-consumer (DTC) clinics.” This phrase might work…but in the “chemical” drug industry, DTC marketed offerings are generally FDA approved so this could be confusing. Witness the massive number of drug commercials on TV that are a form of DTC marketing.
- “Predatory clinics.” In many cases this is accurate as clinics take advantage of vulnerable patients including older folks and young families, but in other situations this is perhaps too harsh.
- “Unlicensed clinics.” This term reflects the lack of FDA approvals and licensing such as a BLA, IND, etc. but it may suggest to some that the care providers lack individual state licensing such as from medical boards, when often times the providers are themselves fully licensed (although not always and some aren’t physicians).
- “Non-FDA approved clinics.” This isn’t a bad phrase (and is similar to the above) and I often use it, but some clinics out there do not need full FDA drug approval (e.g. with autologous and homologous use of unmodified bone marrow), whereas others do need such approvals so it’s still arguably not ideal in some cases.
- Unproven clinics. I like this term even if it isn’t perfect. The point of this descriptor is that there generally isn’t solid, properly controlled data to back up what is sold at many stem cell clinics. This means that what is sold is unproven. However, “unproven” is kind of a vague term. Who decides what is proven? In science we rely on data and a community consensus over time.
- Snake oil clinics. Some clinics probably are selling basically snake oil, but this term carries a lot of baggage. If one is talking about a specific clinic, using the descriptor “snake oil” in the public domain might get you a threatening letter from a lawyer too.
So, what should we do?
What’s a good, concise way to refer to “for-profit, direct-to-consumer, unproven stem cell clinics that lack FDA approvals.”
One shorter combo is “unproven, for-profit stem cell clinics”. This nomenclature highlights the lack of rigorous data at almost all of the clinics and the focus on generating profit from patients for still experimental offerings, which again differs from traditional clinical trials.
Another option is just to stick to the simpler, most dominant present “stem cell clinic” terminology and for the rare instances of a rigorous, FDA-approved stem cell clinic (which are much rarer today), other adjectives could be added to its name for clarification.
I’m still on the fence as to the different options.
What do you think? Take our poll above. And if you don’t see what you think best, weigh in with a comment on the post.
17 thoughts on “What should we call “stem cell clinics” & is “snake oil” too harsh for some?”
FDA approval? Certainly the fall back and let us not forget how well they have served us. Where were they on opioids? Shingles? Vioxxx?
22 drugs that FDA failed to act on https://www.ptcommunity.com/news/20170515/fda-report-examines-22-drugs-passed-phase-2-flopped-phase-3
Stem Cell is real. To the articles defense, the opportunity for swindling exists because the general public has no idea what they are being injected with. Dosage? Biologic content?
But for someone that has done close to 40 hours of research, companies, and is being injected by one of my own specialists with the highest quality of product I was able to find in the highest concentration I remain hopeful. The pain is real and cortisone or joint replacement is not going to happen. I will update…….
“What’s a good, concise way to refer to “for-profit, direct-to-consumer, unproven stem cell clinics that lack FDA approvals?”
Just pure evil.
Call them “dubious” is like calling a mass murderer a little anti-social. And anything that interferes with clearly criminalizing these scams is equally evil. That includes most of the medical community. You can even find these scammers advertising, in effect, in Clinicaltrials.gov. The reaction to being informed of this is “Oh really.”
Intentionally putting people at risk, both from the “treatment” and by steering them away from actually therapy, is only part of the crime. Taking advantage of the gullible is only part of the crime. The greater crime is the harm done to the potential of stem cell research. The majority of experience and press in the use of stem cells, other than hematopoietic stem cell transplants, is taken up by clearly criminal scammers. The entire field suffers as a result. Who would want funding to go to chondrocyte replacement therapy for arthritis if they associate it with scams?
I’m glad you don’t have the last word on Regenerative Clinics. Michael. I’ve benefited from the one I’ve been to on several occasions. As a regenerative medicine patient, I have never felt at risk for having the procedures I’ve had performed on me. So you do not speak (or write) for me and many others as well. The idea that regenerative clinics are harming the potential of stem cell research is completely backwards. From what I’ve read on this blog it seems to me that in fact it is a number of those in stem cell research who are trying to do exactly that to the practice of regenerative medicine. Your notion that patients who frequent these clinics for medical help are gullible is at the very least condescending. It really smacks of a kind of stem cell aristocracy or scientific elitism which I have written about before on this blog. If you are one of those who is healthy enough to not seek out regenerative therapy, then fine. Don’t seek out regenerative therapy. But don’t put thousands of patients down for making our own healthcare decisions without your or the FDA’s blessing.
I think that legitimate clinics (there are less than 10 by my count) should identify themselves (like we do) as orthopedic surgeons who have orthopedic surgery fellowship training in sports medicine with expertise in immunology and stem cell biology (unless you don’t have any).
I want to introduce the term Musculoskeletal Immunobiology for how I practice and for what my hobby has been since 2006. I’m not an injection salesman but I think it’s really funny how you pile on all of the losers who are. I for one, appreciate your personal consideration and respect.
This is a great article to read and understand for anyone who wants to practice Musculoskeletal Immunobiology. Agree that when you see “stem cell clinic” without an obviously reliable surgeon with everything to lose if your result is bad, you should save your money.
It’s all about mechanotransduction. Understanding this and the relevant mechanisms are critical to identify excellent patients and enhance prognostic skills. If you want to maintain significant relief of symptoms for more than 5 years, have to unload the joint. Diffusion weighted MRI tells you what you need to know. Simple as that.
Additional elaboration of the mechanisms behind arthritis and autologous biologics available upon request.
I’d like to see citations in respected journals, as well as published results of peer reviewed clinical trials.
So would I with regard to embryonic and induced pluripotent stem cells proving safety and efficacy despite all of the research money thrown at it having taken place for well over a decade. Something beyond just how excited researchers are about the latest revolutionary breakthrough and how clinical applications will possibly one day perhaps quite likely in the distant or not so distant future maybe come to fruition…… with continued funding! CIRM comes to mind which “has yet to finance a therapy that is available for widespread use” http://www.mygovcost.org/2017/09/29/stem-cell-scam-still-redistributing-money/
The clinic that I’ve frequented in times past has in its’ title the words “Regenerative” and “Medicine”. They provide services that utilize bone marrow as well as adipose tissue (The last I checked though I haven’t been in a while) They also use Platelet Rich Plasma or PRP which I believe I have responded to favorably. Why not just call them Regenerative Medicine Clinics or Regenerative Clinics? Those seem like fairly neutral terms to me not designed either way to suggest to potential patients a particular bias. Many of the previous names listed above seem anything but neutral. Predatory Clinics? That name sounds to me as though it originated from somebody with a serious ax to grind. It just doesn’t seem to me to be in keeping with objectivity.
I would not use the term “stem cell “ clinic at all. An enormous majority of these clinics are delivering a mish mash of dead tissues/ cells/ debris. If you can’t prove that you have at least 1 million MSCs with greater than 70% viability in your product, then you are falsely advertising, unethical and putting patients at risk. Let’s get the nomenclature straight. If a physician relies on a sales rep to tell them that they are injecting “stem cells “ then they should turn in their medical license.
THANK YOU VERY MUCH DR. GARZA, FOR SPEAKING OUT FOR THE “PEOPLE”, WHO, OUT OF DESPERATION, CAN PLACE THEMSELVES IN A SITUATION OF “DOOM”!!!!!! I FOUND YOUR COMMENT TO BE SO INSPIRING, THAT I WROTE IT DOWN TO PRESENT TO ANY “STEM CELL” CLINIC WE CONSIDER INTERVIEWING. IF YOU ARE AWARE OF ANY REPUTABLE DOCTOR, WHO IS CAPABLE OF SUCCESSFULLY REGENERATING WHAT IS DAMAGED, DUE TO A DIAGNOSIS OF MS, PLEASE NOTIFY ME. WE ARE DESPERATELY SEEKING HELP, BUT CANNOT AFFORD FURTHER ISSUES FROM MISHANDLED TREATMENT! THANK YOU AGAIN FOR YOUR INPUT!
Don’t most practicing doctors rely on those without scientific or medical degrees (drug sales representatives) to tell them even in a pharmacologic sense how particular medications function based upon their ingredients? I’d be interested in finding out where you pulled your figures from regarding “An enormous majority” of what these clinics are delivering . Did you work in a regenerative clinic where you were centrifuging blood for platelet rich plasma injections? Did you work with adipose tissue or bone marrow aspirate? I’ve never had stem cell injections at the clinic that I frequent. However, there’s never been in my experience any doubt that the blood being drawn from me is exactly that which is being returned in the form of knee injections centrifuged to a higher concentration of growth factors. The clinic that I’ve been treated at does consult with a plastic surgery practice for adipose tissue removal and processing. To me it just does not seem in a clinic’s best interest as a medical practice to deliver anything other than what is being requested and agreed upon between doctor and patient. However, I would be cautious about receiving any allogeneic transfer of bodily fluid and/or tissue, I can certainly understand the need for FDA regulation with regard to proper labeling in this instance. But that ought to happen well before such materials find their way into a medical practice of any sort.
I prefer the term quackery but have also been struggling with this. I’ve been considering the term “Disproven and Unproven Medicine”, abbreviated DUM. Everyone should call these clinics DUM.
I think words typically used in the mainstream like complementary, integrative, and alternative are confusing marketing terms.
I got rooked to be tune of $4,500. Hopefully a class action suit will eventually be brought against Dr AB and I might recoup some $$.
Editor: Dr’s name changed to AB
I don’t think that any sort of name calling will really do the job. Perhaps, instead, a list of specific criticism of clinic/treatment.
Here is the catch: Any specific criticism may result in legal action. Any nonspecific criticism is really just a general slur, not helpful.
Jeffrey Beall published a list of “predatory” journals/publishing companies. But even for such a relatively straightforward thing as publishing, the issues are not so straightforward…
The way I see it, we are a small-group animal. Whereas evolution found a solution in which termites in large colonies are regulated by biological/chemical means, we seek to do it with strange, ad hoc, and arbitrary things called “laws” and “culture”. Beyond a certain point, it just doesn’t work.
By “called” I didn’t mean “name calling”, but rather what nomenclature to use both for specific or broader cases.
Didn’t Beall have to disassociate himself from that list due to threats of litigation or something?
@Paul, While I am a firm believer in the future of the success of groundbreaking stem cell therapies, it has to be be backed by science. My article yesterday about an additional $56 million investment in Atherys by Japan based Healios is evidence of the field moving forward in the proper manner to treat more than one malady: https://seekingalpha.com/article/4156157-athersys-gets-56-million-healios-stem-cell-deal As far a name that captures the essence of stem cell clinics that don’t go through this process yet charge patients for expirimentaion? I think Stem Cell Hype Clinics is appropriate.
As a six-time patient of ABC, I voted for the second choice in the poll, “Stem cell clinics”. The ABC uses only autologous stem cells, i.e. stem cells harvested from the patient by medical techs and treated at the clinic for re-injecting them into the patient during their visit. I am a stage-four COPD/Emphysema patient aged 77 years.
I actually visited another “Stem cell clinic” closer to my home recently, and was shocked to learn that their “clinic” did not do the treatments. They said that the patient does the treatment, with or without the help of another person that the patient had to find to do it.
I have found only the most professional procedures at the ABC, and will probably never leave it for another clinic, especially if those others are as unprofessional as the one I mentioned. I withold their name out of fear of a law-suit.
I have discussed the ABC with all my doctors, and I have never heard any derogatory remarks about the ABC from any of them, with the exception of the un-named clinic referred to above.
I have never heard of a medical clinic of any kind make a written guarantee of success for any patient, but it seems like that is what some people seem to think they get when they agree to have treatments at the ABC, which has a couple of pages of possible bad results from their treatments in the bunch of documents required before treatment is rendered.
The professionalism at the ABC is the reason I voted for “Stem cell clinic” in your poll. The ABC is in my opinion a classic model for a well-run, above board clinic. But I would advise using the same term for any clinic which is in the same type of service business. There is no Yellow Pages section reserved for “Crooked Used Car Sales”, and there are good reasons for that, even though we all know that some do exist. I think those reasons apply to stem cell clinics as well.
A poll that would be of interest and value to the entire stem cell industry and its public and patients would be to poll patients of all the clinics to determine how they would rate many aspects of the overall experience of their stem cell treaments.
Editor’s note: The repeated use of the name of a specific for-profit clinic was replaced in this comment with “ABC” to avoid a potential promotional outcome for a particular firm.
With regard to “for profit” versus “non-profit” medical care providers, my charges from “non-profit” institutions have been dramatically higher than charges from “for-profit” providers on an apples-to-apples basis for comparable services provided. The non-profits where I have received care have been major university teaching / research hospitals. Admittedly my experience is only anecdotal, but for me when I think about “non-profit” versus “for-profit” the for-profit medical practitioners typically charge me far less. I have noticed that non-profits have a tendency to uplift the CPT codes to produce higher charges. Again, this is based on my personal anecdotal experience, but it happens consistently enough that there seems to be a pattern.