For-profit stem cell clinic secrets are bad news for patients.
Stem cell clinics are in the business of making profits above all else and to make steady money they need a strong flow of patients as their paying customers for their non-FDA approved offerings. In order to keep the money pouring in, some of the clinics may not be completely truthful with patients. These clinic secrets can be directly told to prospective customers or implicit in the operation of the business. Below are the top 10 stem cell clinic secrets that clinics don’t want patients to know because then the businesses would lose money. In many cases the clinic businesses themselves have told me these realities kept from patients over the years.
- Not enough cells. Often there almost certainly aren’t enough living cells in their treatments to do any good. Some of the clinics have actually told me over the years that they are convinced that to really work the treatments require cells have to be grown in a lab first to have sufficient numbers. But, even so they sell the non-proliferated cell treatments that they themselves believe to be underpowered because of too few cells. Nice, huh?
- Even they aren’t believers. They don’t really believe their treatments work. They often are counting on the placebo effect. They have actually said this on rare occasions. They are selling a placebo for $5K, $10K, or even $20K a pop, but mostly don’t want to admit it.
- People have been hurt. Some of their customers have been harmed by them over the years. People have died, been blinded, had tumors sprout up, have bone grow in their eyelid, and more. The clinics don’t tell new customers about this. Some even say the offerings are “100% safe”. Really?
- Millions in profits. Some of the businesses are making millions off of customers. The clinics are roughly estimated to have total costs per treatment of about $1,000. While they generally do not release patient volume stats, estimates suggest that many of the clinics are making millions off of patients in profits. But the clinics portray themselves as just being in it for the well-being of their patients like some kind of “Robin Hoods of stem cells”.
- Stem cell newbies. Some clinics don’t know squat about stem cells. So some clinics have physicians who are long-time experts in stem cells and transplantation, but most don’t. Some even have been trained by folks who don’t have an M.D. or even a Ph.D. or anything.
- Non-specialists. If you have a specific condition, you need a specialist. CNS problem? Do you really want a dermatologist, plastic surgeon or urologist handling your case? Respiratory problem? Don’t you want a pulmonologist? Have M.S.? Do you really want a cosmetic surgeon treating you? It makes no sense. Just because stem cells are involved doesn’t remove the need for speciality training.
- They’ll experiment on kids. Some stem cell clinics have pediatric customers. Providing medical care to kids raises unique medical issues and ethical considerations. Some clinics shouldn’t be treating kids with a 10-foot pole because they just aren’t qualified, but they do it anyway for the money.
- Safety shmafety. “The worst that can happen is that it won’t work” is like a mantra for some stem cell clinics, but it is total B.S. Most of the clinics don’t really know them to be safe conclusively based on properly controlled studies. But they say the treatments are very safe anyway to reassure customers.
- Past-patient or recruiter? There are so many patient testimonials out there and there are some patients who energetically advocate for specific clinics. In some cases, these patients truly believe they’ve been helped and want to spread the word, but sadly in other cases the people portraying themselves as patients are either patients who are receiving payments/discounted treatments from the clinics or not patients at all, but are rather recruiters for the clinic posing as patients. Some claimed patient satisfaction rates at certain businesses also seem a bit too good.
- FDA?  Lately the clinics are adding more disclaimers to their websites such as “The stem cell treatments offered here are not claimed to have any benefit and are not FDA approved”. Sometimes the sites say outright that they do not need FDA approval. At best that’s a highly debatable statement. Some of them don’t really believe they exempt from FDA rules. They’re just hoping to be lost from oversight by the FDA in the herd of hundreds of other clinics. Or they just don’t really give it much thought at all. We’re hoping our new law on stem cell therapies here in California will help with this problem.
Overall, keeping secrets from patients is all about profits, not patient wellbeing.
My daughter was “floxed” late last year and has tendon issues as a result. She knows of doctors in the San Diego area who use stem cells to treat this. She is reluctant to go with them – I generally cite the moderator’s reticence to her which seems to be based on a lack of trial based evidence for its effectiveness in many areas. As far as ameliorating symptoms, she has had some luck with the OTC remedy mitoQ.
@Li You Hu,
What is “floxed” in this context?
Floxxed is fluoroquinolone poisoned. See extensive FDA Black Box warnings.
Can stem cell treatment be used for Fluoroquinolone toxicity…with multiple systemic problems..similiar to Lupus or other autoimmune diseases..I have been in fairly constant pain for 17 years because of overprescribing of Cipro, Levaquin, Avelox, Tequin etc. for sinus infection and UTI…I need help…any information would be appreciated.
Dear Admin:
Thank you for posting Dr. Wesely’s response.
Dear Dr. Wesely:
Thank you for sharing this perspective and experience so eloquently.
It is always easier to frame complex social and government policy controversies as villains vs. saints, though such characterizations are rarely a faithful representation of the real situation. If those, who claim to have the purpose of serving the public good, do not do the harder work of a comprehensive and diligent incorporation of all the significant factors involved, they will deceive and cheat everyone…including themselves.
Dr. Wesely, thank you for modeling a more encompassing representation of the nature and quality of current private clinics in the U.S. that provide “stem cell treatments.” Such honesty and fairness will accelerate achievement of a solution that is generally acceptable, and more important, provides the greatest benefits to patients.
Yours (both) sincerely,
James @ Asymmetrex
Dr. Knoepfler,
I have been a distant follower for some time, and have admiration for your drive to keep treatments in the stem cell space “above board” and free of fradulent deception. Your are also an accomplished scientist who has contributed to the field of stem cell research, and I respect your opinion. Nevertheless, I would have you reconsider your generalized presupposition that all physicians are ingnorant deceivers, have no understanding of basic science, and have no interest except to swindle unsuspecting patients. In my experience, nothing could be further from the truth.
Although one can always find unscrupulous health providers, the same can be said for researchers. As a clinician with over 25 years of practice, I have lived through numerous medication and device approvals, only to see them later recalled after patient injuries and deaths. Vioxx, bone morphogenic protein, and more recently Oxycontin come to mind. Numerous medical devices could also be mentioned. All these products at one point showed “statistical significance” regarding efficacy in large studies, but the treatment endpoint targets and patients were cherry picked to appear better and safer than the raw data showed. Although the FDA process was successfully completed, and therefore these companies could now advertise and market to the public, is a 10% reduction on a scale really meaningful for patients? Lets face it, for many drug and device manufacturers, FDA approval is a golden ticket to start printing money, since our current system does not take cost and value into serious consideration (especially within Medicare). So I ask you, do you have an independent mind when you give your opinions? Or are you trying to agressively dismiss a form of treatment which may not exactly fit within the current medical-industrial complex? Who funds your research? Read the recent book by Dr. Elisabeth Rosenthal “An american Sickness” for more details. I have no doubt than any allogenic stem cell product created by a big biopharmaceutical company, which becomes FDA approved, will carry a tremendous price tag compared to a simple autograft done at point of care.
Regarding scope of practice, I totally agree that any provider considering early adoption of these types of treatments should be practicing in their “wheelhouse” of specialization and experience. My parter and I have over 65 years of experience in treating orthopedic, musculoskeletal, spinal, and chronic pain problems. We do not treat any other types of conditions. We only perform treatments which have shows acceptable safety and efficacy in the literature in human studies. For each and every condition we evaluate, we are fully versed in the scope of treatment options and how stem cell treatments may or may not be a reasonable option. I will typically turn down at least 1/4 to 1/3 of the patients I see, because they are poor candidates for these types of treatments. I recently worked hard to convince one patient to NOT go to any clinic which said they would used stem cells to cure her husbands Parkinson’s, when I refused to treat him.
Regarding stem cell assays and procedures at point of care, this is not that challenging if a clinic is truly committed to quality patient care . Yes, this costs money. Most cities have Universities with biomedical laboratory facilities sporting reasonably good flow cytometry teams which can help characterize one’s preparations with regards to surface markers, and culture characteristics. Obviously, we are not culturing cells. At point of care, we use the Luna-Stem counter (Logos Biosystems) which gives us TNC and viability numbers for both BMAC and ADSC preparations. All of our tissue harvesting and preparation procedures are carried out in an office operating room type setting, and under a pair of 4 ft biosafety cabinets, all of which are regularly independently certified. Nearly all of our injections are carried out with image guidance. In five years of practice, we have not had a single injury, infection, or complaint. “.”Above all else, do no harm.” We are also following our patients (the best we can) with standardized instruments (McGill, WOMAC, KOOS, Oswestry, etc) to see how they are doing over the long haul. In our practice, these treatments appear safe, which is consistent with the clinical literature.
Finally, with regards to money and greed being the only motivator for physicians in this field, let me give you some perspective. We do cover our overhead, but not by much. Personally, I still have “day job” practicing more conventional medicine because our practice is driven by passion for better options for patients, and not because it is a “cash cow” for me. Most physicians would be more profitable practicing conventional medicine, and treating patients with steriod injections and pain medications, until they go on to joint replacement. All of our patients receive a comprehensive evaluation before considering any treatment. Do you honestly think a medical practice, which does not take insurance, can survive long term on slick marketing and the placebo effect alone? I beg to differ. Poor results, injuries, and patient complaints spread like wildfire in any community, and will soon sink any cash based practice which does not deliver reasonable results. Over the long term, an informed market will not be fooled. BTW, both myself and my immediate family members have received these treatments with reasonably good results. I find it a bit insulting that your blog suggests that most physicians advise patients to receive treatments that they would be unwilling (under the same circumstances) to undergo themselves, and don’t believe it works. A very unfair generalization.
Your assessements regarding organizations with business models like XXXXXX are accurate. I called them. No X-Rays or physician evaluation required! Outrageous claims. Marketing a tissue graft as stem cells. Injections not carried out by physicians or supervised by physicians. But please don’t put everyone in the same bucket. Several medical organizations in this field, such as The Orthobiological Institute and the Interventional Orthopedics Foundation are flourishing, and helping to bring clinical data to bear. Remember, there are various ways to arrive at scientific truth. Sometimes a basic science discovery leads to an efective clinical treatment. Sometime we stumble on an effective clinical treatment and the basic science is figured out in reverse. The data guides us both as we stumble along and try to understand.
Cheers,
Dr. Andrew C. Wesely, MD
Dear Dr. Weseley,
Thanks for your comment.
I think we can agree that not all the clinics or providers at such clinics are the same. I’m aiming to discuss such differences more often here on The Niche.
Some clinics/providers are relatively much more responsible, such as by staying in their area of clinical speciality and not willy-nilly testing out high-risk experimental protocols (some that don’t even seem to make common sense) on unsuspecting patients in ways that have no data to support them.
But over the years I’ve seen a very large number of firms that are seriously problematic on so many levels and patients have reached out to me with negative outcomes they have had. It’s a dangerous mess.
I’d be curious of your reaction to the 10 draft recommendations of the working group of the Federation of State Medical Boards:
https://ipscell.com/2018/02/pending-state-medical-boards-group-report-on-stem-cell-clinics-could-be-game-changer/
Paul
Paul,
Thanks for your comments. The draft FSMB recommendations you referenced above are all very good recommendations. In fact, they are similar to the draft Orthobiologic Ethic Statement put forward a few months ago, which our practice signed and agreed to abide by (https://orthobioethics.com/the-orthobiologic-ethics-statement/).
I think the concept of “direct-to-consumer” medical treatment marketing is very interesting. You and I both know the horse is probably long out of the barn. A few years ago, when regulators allowed, Big Pharma started saturating the airways with drug treatment ads. I see no signs of this letting up. Having an extensive background in pain management, I find it remarkable that Purdue only stopped marketing Oxycontin (for nonmalignant pain) to primary care physicians this past week. Remember that opioid misuse kills about 7 people per day, and Oxycontin is FDA approved. Nevertheless, I think the FDA should (and eventually will) crack down on clinics making unsubstantiated claims which have no basis in scientific publications.
Practitioners entering this arena should be willing to invest the ongoing capital and training required to make these autologous tissue preparations as sterile and safe as possible. As noted above, this should at least include the use of biosafety cabinets for processing, sterile rooms for obtaining tissue, sterile surgical technique, and (in our opinion) prophylactic antibiotics. Although our practice has been spared so far, infection remains my most feared complication.
I cannot emphasize enough the need for physicians using these tools to stay within the scope of their training and expertise. The recently well publicized blindness fiasco in Florida was not carried out by an opthamologist. Enough said.
Finally, the scope of stem cell science is a very broad and vast landscape. Using these cells in a petri dish to test drugs is on a different planet compared to using these cells to treat arthritis. If a paper comes out showing promise in treating stroke by intracranial injection using a neuronal stem cell line derived from iPSC’s, does a rational physician think a bone marrow concentrate can be injected into a patient’s brain to treat a stroke? I know this sounds crazy, but these sorts of extrapolations are occaisionally promoted to patients as rational. This should not happen and is not ethical. On the other hand, if I can read several dozen papers which have used intra-articular BMAC as a treatment for arthritis, and these papers show (1) acceptable safety, (2) acceptably low complication rate, (3) acceptable efficacy compared to other treatment options, AND (4) I can make the same autologous tissue preparation detailed in the study, THEN this becomes a treatment option I can discuss with the patient.
Thanks for all the input. I think these sorts of discussions will benefit all interested parties.
Cheers,
Dr. Andrew C. Wesely, MD
I know various people who have really been helped by this treatment, including my husband. He was able to avoid a hip replacement so far.
Dear Admin:
Here’s the number one secret that private stem cell clinics, FDA-authorized clinical trials, and even approved stem cell treatment centers are keeping from their patients:
None of them know the number of stem cells they are giving to their patients, if in fact any stem cells at all! And, yes, knowing stem cell dose is just as important for developing and providing the most effective and efficient stem cell treatments as is knowing drug dose for developing and insuring the most effective and efficient pharmaceutical treatments.
Your readers can learn more about this secret and what some companies and agencies are trying to do about disclosing and addressing it by registering for “Stem Cell Characterization,” a free online panel discussion co-sponsored by RegMedNet and Asymmetrex (the commenter’s for-profit company) on Nov. 30.
To register: visit https://event.on24.com/wcc/r/1535143/98BB62D05EBA779D34ADFA43D150D077?partnerref=asymmetrex
James at Asymmetrex
Patient exploitation has become rampant due to greed and the facility with which untrained but licensensed non-specialists gain access to the procedures. False advertising and fake news draw patients in for experimental treatments that were not meant for every patient who presents for treatment. There are authorities but patients may not be ambitious enough to seek out the best sources for enlightenment. Search engines are dominated by big corporate business who spend hundreds of thousands marketing their clinically inconsistent brand products. The problem is escalating as these same large corporate entities are forming pseudo-foundations to promote their agenda, rather than promoting patient health and well being. One viewpoint. Plenty of others.
Spot on facts!
Regarding no:5, I even saw an online course selling physicians stem cell training “certificates”
“….You will immediately be able to start offering cutting-edge medical procedures to patients, establish yourself as an expert in your field, and enjoy the benefits of this growing industry….”
A few hours of video, 26 case studies, 12 conditions and few pages of theoretical knowledge then you are done you can get your certificate for “establishing yourself as an expert in the field” .. Hands on training is optional…
Well said, Paul. Should we be silent because clinics won’t tell us what they are doing? No. Since the clinics make their customers sign agreements to be silent (unless they are willing to be flattering), we can only glean information from those who will speak anonymously. Not to interject politics, but doesn’t this seem a bit familiar…attempts to silence negative information?
How do you know that all clinics make “customers” sign “agreements to be silent (unless they are willing to be flattering)” (nondisclosure agreements)? If you have evidence to prove this, please share it with us.
I agree with Francois- this kind of information is valuable. There is no alternative source of information except from the people who have paid these clinics to treat them with something that the clinic says will help them.
Hello Admin and readers,
With all due respect, I would disagree with the two first comments; in my personal view this post is valuable. The lack of information regarding treatments (detailed procedures, potential efficacy, risks, costs…), comes from the lack of transparency from the stem cell clinics themselves. Although we all agree that accuracy is a key element in fact-based (scientific) medicine, informing patients of potential risks is an important issue that cannot wait to get statistically valable data, because clinics don’t wait to catch patients.
Every week patients reach out to me to help answer questions and clarify aspects of this complicated arena. I often think about them when I’m brainstorming what to post about.
It’s too bad, but hardly surprising that so many for-profit stem cell clinics marketing non-FDA approved “therapies” aren’t inclined to publicly discuss or publish information on their marketing strategies to recruit more customers, make larger profits, avoid rigorous oversight, etc.
If useful information in this area is nonetheless available in the sense of being discussed behind the scenes and it appears very likely to be accurate to me, then posting it on my blog in my view is a service to patients and the wider stem cell community. I realize there are diverse views about many stem cell-related topics, but I call it like I see it on my blog.
Hello, Admin:
From your listing:
“Some of the clinics have actually told me over the years…”
“They have actually said this on rare occasions.”
“Some clinics…”
“Some stem cell clinics…”
Well, I guess no one should expect personal opinion blogging to approach the standards for responsible reporting.
List on, but you are capable of more responsible, credible, and useful information dissemination when you are emulating scientific integrity as opposed to when you are just spewing forth with your own personal biases, legitimate or not.
Bored this week-end, or did something occur (or not occur) to get you riled up? 😉
James at Asymmetrex
Exactly. Those kind of statements make the whole post completely unreliable. Very shoddy – especially for a scientist. “The clinics are roughly estimated to have total costs per treatment of about $1,000” (citation please). According to @admin himself, there are hundreds of clinics around the world doing all kinds of different treatments. How can the per treatment cost of $1,000 possibly apply to every one of these clinics? I cannot imagine that the “cost” of one adipose treatment i which the doctor is processing the fat using a bedside machine into SVF is the same as the cost of an adipose treatment in which a cGMP lab isolates and expands mesenchymal stem cells and then sends them to another country to be administered to the patient in a clinic. GMP labs and personnel are not cheap. Does this $1,000 account for the clinic’s rent, employees, taxes, insurance, clinic equipment, etc.? (I could go on)