I’ve seen stem cell clinic ad after ad pop up in the mainstream media in my own hometown in The Sacramento Bee paper, but others are sprouting as well and a friend sent me a particularly striking stem cell advertisement from a recent copy of the San Francisco Chronicle.
Not only does this stem cell clinic say you can come to a free stem cell seminar, but also you get a free lunch and $1,000 off a stem cell “treatment” of some kind if you go to the seminar.
The clinic in question seems to be called Advanced Health Center. The providers mentioned are Dr. Max Wirjo, M.D. as well as Drs. Brian and Jeff Coyle, D.C., F.A.S.B.E. I’m not familiar with these folks, but looked them up on the web. Wirjo seems to be an anesthesiologist. The Coyles, perhaps brothers, are chiropractors. On a quick search I couldn’t find any other links between these three providers and stem cells on the web at least. What kind of stem cell experience do they have?
The ad makes a number of potential medical claims including that the marketed offerings can “fix” a number of medical problems (see the big “FIX IT!” in the ad). The offering is described as effective, which is a medical claim, and in fact is called “most effective”. There are also claims of “long lasting” results. It is at least indirectly implied that the stem cell therapy being marketed can grow new cartilage, ligaments, and muscle, which is a very big claim. On their website on the stem cell therapy specific page, claims are again made in videos from R3 Stem Cell.
Does this seminar being promoted fit into the category of what I call “stem cell clinic infomercials”, which I wrote about recently in a Stem Cells and Translational Medicine article here?
When I see an ad like this, other questions come to mind. What data if any is behind it? How many patients will be experimented upon? How much patients pay? What are the risks and potential negative outcomes? Have they talked to the FDA?
Have you all seen ads like these? If so please send my way. Thanks.
Over the years I’ve been keeping my eyes open for advertising by stem cell clinics and lately the ekspresi dominan is big splashy ads in mainstream media including large daily newspapers such as the SacBee, the San Francisco Chronicle, and now the Seattle times (see below from today’s).
Seattle times stem cell clinic ad
These kinds of big ad buys on front or back pages can cost tens of thousands of dollars or more. What this means generally is that clinics are already earning or hope to make hundreds of thousands or millions of dollars in profit from vulnerable patients. Do the patients get anything real in return in the way of the “stem cells” helping their health conditions? What about safety issues and other risks?
This goes beyond science and medicine to consumer protection as well. Many clinics use seminars that are often mentioned in the ads, what I call stem cell clinic infomercials, to recruit new customers. There’s some evidence that certain clinics do not even have living stem cells in what they inject into patients, although the product is marketed and discussed at seminars in a way to make consumers think it is living stem cells, it definitely works, and is safe. A consumer website called Ripoff Report has posted on a patient’s self-reported negative experience with Stem Cell Institute of America, the sponsor of the Seattle Times ad above. I don’t know the accuracy of the material there, but it does raise questions.
The fact that there are so many of these ads now showing up across the U.S. also is a sign of the continuing geographic spread of the stem cell clinic industry. This proliferation is arguably in part because state medical boards and the CBER branch of the FDA have passively stood on the sidelines for years even though the clinics generally have no FDA approval and little if any data to support what they are doing.
A few clinics’ practices using stem cells are within a narrow window of both homologous use and minimal manipulation (e.g. largely unmanipulated bone marrow cells used only for orthopedic applications) whereby they most often do not need the full FDA drug approval for what they are doing. However, in my opinion most clinics out there today do not clearly fit into that category and so instead should be getting FDA approval in advance of marketing.
The bottom line is that this big collective, unapproved and for-profit human experiment by hundreds of clinics continues…the mushrooming, expensive ads are a flashing neon red flag of just how big this kasus has become.
“Are you a motivational speaker?” is howa recent stem cell job ad for a sales position related to stem cell clinics begins.
This ad that popped up on Monster earlier this summer is a revealing window on stem cell clinic practices. What’s inside, in my opinion, is cause for concern. Lately we’ve seen more and more ads for stem cell clinics targeted to patients, but this particular ad is a job opening and it kind of spills the beans on what the clinics are doing and their financials.
Amongst other things this stem cell job ad promises big money (“the right candidate will earn a very nice 6 figure income!”) for sales people if they can get enough patients in the door and care providers engaged. It asks potential applicants, “Would you like to get paid what you are worth?” and then later more specifically points out that, “Each sale earns a 1%, 3% or 5% commission.”
All that money will be coming from patients, either directly or indirectly, as these procedures are not covered by insurance. Since in general what stem cell clinics are selling is not supported by properly controlled, pre-clinical or clinical studies published in mainstream journals, and is not FDA approved, overall is this kind of offering within the stem cell clinic field fair to patients?
If we do a simple back-of-the-napkin calculation on the suggested income in the ad, assuming $200,000 a year in income and 3% average commission, the desired stem cell sales person would have to sell about $6.6 million in stem cell offerings per year. At the quoted $8,500 per procedure that’s around 750 “treatments” sold by the salesperson, which works out to about two per day, 365 days a year. Even if we cut the possible salary in half to $100K, the lowest 6-figure salary, the number of “treatments” to be sold and patients potentially impact is still very large.
This position seems to be targeted toward getting an inspirational sales person to talk both to patients and to also motivate care providers who will then sell stem cell offerings to patients:
“This job involves 2 days per week in the clinic, educating and teaching prospective patients about Stem Cell Therapy and then getting them to commit and buy this amazing treatment…Your other days will be spent talking with family doctors, Chiropractors, Specialists and Physical Therapists, teaching them about Stem Cell Therapy and soliciting referrals…You will also be “servicing” our doctor clinics taking them coffees, lunches and socializing with the staff. You will do weekly lunch learning workshops and the occasional dinner workshop.”
The verb “servicing” that the ad itself puts in quotes means schmoozing those care providers into selling stem cells?
And what exactly is the “amazing treatment”? Is it safe, and does it work?
As to the clinics that might be some of the customers for the stem cell offerings, who are they and for the “Specialists” what is their training? It’s also not clear whether Chiropractors or Physical Therapists, which are mentioned in the ad, are qualified to administer stem cell treatments.
The fact that the ad mentions in particular “older clientele” as sasaran customers is a concern to me and resonates strongly because many clinics seem to sasaran older patients to recruit new customers. In my view when selling experimental stem cell offerings to either pediatric or older patients, extra care should be taken in the consent process and at other stages, perhaps including consulting a bioethicist.
Who exactly is the employer here behind this job ad?
It’s not clear to me as the ad says, “Medical Sales at Stem Cell Centers Towson, MD 21204”, but I couldn’t find a clinic or other stem cell business there. Perhaps the business running this ad is more of a “middle man” that doesn’t actually do treatments itself? If that is the case, then it may not show up on the radar as much such as via a Google search for “stem cell treatment Towson MD”.
Overall, this job ad reveals some striking aspects of the stem cell clinic industry and highlights the big money perceived to be made from patients.
The five total named patients involved in the suit include four new ones Alexandra Gardner of Colorado, Stephen Ginsberg of California, Jennifer Brewer of Montana, and Rebecca King of Arkansas, and then the original plaintiff Selena Moorer, who is a resident of Florida. Reportedly each StemGenex customer paid $14,900 for their stem cell transplant.
Notably, four of the patients mentioned in the document traveled from other states to the San Diego area to receive stem cells from StemGenex. This seems to be a more general thing with the business and its customers as the amended complaint document quoted the StemGenex website that, “over 70% of patients travel to StemGenex Medical Group from out of state.”
Besides the business itself, the Defendants listed include the following: “ANDRE P. LALLANDE, D.O., SCOTT SESSIONS, M.D., RITA ALEXANDER, and DOES 1-100.” The LA Times recently reported that Sessions was the subject of California State Medical Board action. I think that he is no longer associated with StemGenex. For other archived posts on StemGenex see here. The new court document indicates that the health conditions of the plaintiffs for which they thought stem cells might help include lupus, diabetes, painful spine and joint condition, and Multiple Sclerosis (MS).
More broadly businesses marketing non-FDA approved stem cells to patients claim that stem cells can help a whole array of health problems. In my opinion it is highly unlikely that one or even two types of stem cells could be a safe and effective way to treat so many conditions. The data just isn’t there from properly controlled studies.
The suit against StemGenex makes specific allegations about the clinic’s marketing and practices. The first 3 parts of the action described in the new document provide some sense of the specific major allegations:
“1. This is a class action against STEMGENEX MEDICAL GROUP, INC., and related persons and entities (collectively, “Defendants” or “StemGenex”). This action arises out of StemGenex’s scheme to wrongfully market and sell “stem cell treatments” at their La Jolla, California location to consumers nationwide.
2. StemGenex’s consumers are often sick or disabled, suffering from incurable diseases and a dearth of hope. StemGenex’s marketing makes claims to these consumers that by performing liposuction of a person’s 4dukt fat cells, processing them, and injecting them back into a person as stem cells (the “Stem Cell Treatments”), they effectively treat a multitude of diseases.
3. StemGenex claims that 100% of its prior consumers are satisfied with its service. StemGenex has no reasonable basis to make the claim it has made about 100% consumer satisfaction. StemGenex omits material information from all marketing about the Stem Cell Treatments and the dissatisfaction and complaints of ineffectiveness from people who have purchased the treatments.”
The case remains open and to my knowledge its class status is not yet approved. The specific allegations also have not been addressed in court as to their veracity. The case could be dismissed, it could proceed as a class suit or move forward but not as a class suit, or it could be settled.
How far will stem cell clinics go to market their non-FDA approved “treatments” that they often claim will have miraculous results?
I’ve never seen anything quite as striking as what some clinics in the Seattle area are now doing.
In the past, we’ve seen clinics take researchers’ pictures, quotes, or videos to use for their own marketing. In the last 1-2 years we’ve seen increasing numbers of mainstream media ads for clinics too (see here and here, for example) so the clinics are thinking spending a lot of money on ads is a good strategy. Some clinics also succeed at getting listed on Clinicaltrials.gov even though they mostly aren’t doing IND-based clinical trials.
They’ve been busy!
However, the latest seems particularly striking. Two related Seattle area stem cell clinics are oddly enough marketing their apparently non-FDA approved offerings, using a quote from the new FDA Commissioner, Dr. Scott Gottlieb (a hat-tip on this to Dr. Erica Jonlin of the UW in Seattle.)
In their ad in the Seattle Times (above) and on their website, adipose stem cell clinic Generation Stem Cell is using part of a quote from Gottlieb that expressed his general excitement about stem cells and regenerative medicine. Did Generation Stem Cell get the FDA’s or Gottlieb’s permission to use his quote in their ad? I strongly doubt it.
Perhaps not surprisingly the business doesn’t quote some of Gottlieb’s other, very different recent statements on stem cells including this one about the direct-to-consumer stem cell clinic arena:
“Products that are reliably and carefully developed will be harder to advance if bad actors are able to make hollow claims and market unsafe science. In such an environment a select few, often motivated by greed without regard to responsible patient care, are able to promote unproven, clearly illegal, and often expensive treatments that offer little hope, and, even worse, may pose significant risks to the health and safety of vulnerable patients.”
To be clear, I don’t know if Gottlieb would view Generation Stem Cell as a “bad actor” and I’m not making any allegations about this business. However, there are some issues here warranting questions and discussion.
Like a large number of stem cell clinics across the U.S., again as best as I can tell this firm doesn’t have FDA approval for their adipose stem cell treatments (see more below) and based on recent FDA finalized guidance, adipose stem cells are most often going to be drugs requiring pre-market approval. So is Generation Stem Cell compliant? I tried to learn more from their website.
On the site they have a FAQ section including this question, “Is stem cell therapy FDA approved?” I found their answer to this one to be rather surprising:
“No, stem cell therapy is too new to be approved by the FDA. However, the FDA does have guidelines about treatment and manipulation of a patient’s own tissues. The Generation Stem Cell procedures and protocols meet those stringent guidelines.”
Is “too new” to be approved by the FDA a thing? I don’t believe so.
I’d also ask the clinic, “Have you read the new finalized FDA guidelines including relevant sections on adipose stem cells? Why are you so confident about your clinic meeting the FDA’s guidelines? Has the FDA said specifically to you that you meet their guidelines?” If the clinic has good answers to these questions, I hope that they let me know and I’ll post them.
Generation Stem Cell makes some medical claims in their ad and on their website too including for patients to become “pain-free” and invoking some kind of “miraculous ability” of fat stem cells to repair damage (see my red circle highlighted text in the screenshot from their website). What is the basis for these claims? Is there hard, peer-reviewed data?
Like many other clinics, this place also is offering promotional seminars via their ads to attract new customers. Their website also seems to indicate an affiliation with two other nearby clinic-like entities: Bellevue Pain Institute and NW Pain Relief Centers as you can also see their logos in my screenshot. The former firm itself mentions miraculous effects and quotes Gottlieb too on their site.
Bellevue Pain Institute announced on their website that they are now part of Cell Surgical Network, a large, affiliated group of stem cell clinics selling non-FDA approved adipose stem cell offerings across the U.S. and abroad. Some important medical claims are made on their site too, including of 100% safety:
“Within the Cell Surgical Network over the last 7 years we have performed well over 7000 recorded and tracked adipose derived stem cell procedures and have recently published our safety study showing 100% free of significant side effects.”
One important thing I don’t see on the Generation Stem Cell and NW Pain Relief websites is mention of the specific physicians or other care providers who will be conducting the stem cell procedures. Maybe I missed it. The Bellevue Pain Institute mentions its providers here, including chiropractors and at least one naturopath. Are the providers listed qualified to be giving stem cell transplants? If so, how so?
In the bigger picture, there are clear indications that the for-profit, direct-to-consumer stem cell clinic industry continues to expand across the U.S. Although the FDA has given some encouraging signs about their awareness of the importance of proper oversight of this industry, more needs to be done including concrete steps. Every day I would estimate that many hundreds if not thousands of people are receiving (and paying large sums of money for) unproven, experimental, and non-FDA approved stem cell injections in the U.S. alone. Consumers are being drawn to the clinics via ads and websites like those discussed in today’s post.
Even as some unproven, for-profit stem cell clinics promote themselves aggressively in many ways including now on TV, on the flip side lately we’ve seen more TV journalists covering questionable marketing by the clinics and negative patient outcomes.
Today I saw that CBS This Morning, a national broadcast, had a fairly long TV segment on stem cell clinics. Even though the segment wasn’t perfect, it did a pretty good job overall. It was mostly focused on the case of patient Doris Tyler who alleges she went blind after getting fat stem cells injected into her eyes by a Georgia clinic belonging to Cell Surgical Network. Tyler has filed suit.
She was examined by eye expert Dr. Thomas Albini (pictured in screenshot from the CBS video below), who has reported on a number of patients he has examined who have reported severe adverse side effects after going to clinics or participating in other for-profit experimental stem cell procedures. CBS also mentioned another woman who felt she has had a good outcome from a bone marrow stem cell treatment for vision at an unnamed other institution, but details on that were less clear.
Dr. Thomas Albini, screenshot of CBS This Morning video
In another example of a critical look at for-profit stem cell commercial clinics on TV, just a few days ago NBC San Diego did an investigational piece (including a very effective hidden camera video segment) on a local stem cell clinic there. The piece was focused on West2North Medical Solutions, which sells amniotic or placental “stem cell” therapies that are not approved by the FDA nor in my opinion backed up by hard science. The firm has clinics in multiple states. The stem cell offering is in part marketed with informational seminars and NBC San Diego attended one seminar presented by chiropractor Michael Van Derschelden:
“The Carlsbad presentation was interspersed with videotaped testimonials from clinic clients who said “it worked” for them. Van Derschelden told the crowd he specializes in regenerative medicine and uses “un4dukterated” stem cells taken from placentas from consenting donors. The injections come from “shipments from the same placenta,” improving the quality of the injected materials, Van Derschelden explained.”
Jeanne Loring on stem cell clinic segment on NBC San Diego
In North Dakota, West2North’s stem cell clinic was recently investigated by that state’s Attorney General. As a result, the clinic reached a settlement with the state over patient concerns that involved the firm paying around $20K, some of it to the patients. You can see some of my thoughts on amniotic stem cell offerings in the post I linked to above.
The NBC San Diego piece counters the San Diego clinic’s claims with on-camera statements from stem cell scientist Jeanne Loring of Scripps and Kevin McCormack of CIRM, who both do a great job putting this in helpful context. I share their skepticism.
I expect we’ll see even more coverage of stem cell clinics on TV, but perhaps also more TV advertising by clinics too.
There’s the batmobile for Batman, right, but what about a stem-cell-mobile?
RegenMed of Florida’s “stem-cell-mobile”.
Every so often someone sends me some wild new stem cell clinic thing that they’ve seen that is both real and almost unbelievable at the same time.
The latest is a mobile stem cell “clinic” business called RegenMed of Florida, which is what I’m calling the “stem-cell-mobile”.
There isn’t much gosip on this company on the web including on their homepage, but I did find their Facebook page and a picture of what seems to be the stem cell clinic on wheels. I’m guessing this thing cost more than $100K. Maybe $200K if they did it to extremely careful clinical specifications.
It seems to me that the stem-cell-mobile serves a second purpose as a mobile stem cell advertising billboard too based on how it looks.
I’m not making any statements about the claims of this business one way or another at this point (and actually the claims on the web seem pretty vague anyway), but I couldn’t help but be reminded of one of my stem cell editorial cartoons from years back because of the mobile nature of this new thing (see below).
The RegenMed of Florida owner appears to be a physician assistant, J David Barr. From the Facebook page and the company homepage, it seems they sell injections of PRP and “stem cells”.
Although in other circumstances physician assistants (PA) who are parts of IND-based clinical trial teams can aid in doing stem cell transplants and can be highly-qualified professional medical care providers involved in stem cell infusions, my opinion is that a PA shouldn’t be giving stem cell transplants independently. I feel the same way about chiropractors too as they aren’t trained the same way as MDs and DOs where there is such a heavy emphasis on cell biological mechanisms related to medicine. Does the stem cell on wheels firm have a physician overseeing all of what it is doing? If so, I couldn’t find out who.
Also, no specific type of stem cells is mentioned by this firm that I could see. Living amniotic stem cells? “Dead” reconstituted powder? Something else? Maybe the stem cells in question here are non-FDA approved, which if correct would just up the risk further. In my view, the mobile stem cell clinic nature of this could push risks up yet even further related to sterility or other issues.
From the RegenMed of Florida website:
“Through David’s years of treating joint disfunction (sic), he understands the intricacies of pain and its negative effects on the lives of those it touches. He has been relieving the joint pain of his patients in a formal office setting and is now offering his services in a mobile setting for those who don’t want to travel far and wide to seek joint pain relief.
RegenMed of Florida travels to communities across the Tampa Bay area offering no cost consultations to help patients decide if a minimally invasive, non-opioid joint pain relief treatment plan is right for them.”
As I’ve written before, the idea of stem cells for pain right now mostly doesn’t make a whole lot of sense to me, but I’m not a pain specialist. If you can make a joint healthier then there’s probably going to be less pain, but I’m just not convinced specific kinds of stem cells have been proven to do that. It sure seems like clinics are trying to capitalize on this idea big time based on advertising. Some are really into the idea of stem cells as an alternative to opioids as well.
Overall, I’m not a big fan of the stem-cell-mobile idea.
Over the years, some other businesses have even sold “stem cells” as a standalone product to patients who are then supposed to self-inject, which seems like a really bad idea to me.
What’s next, Uber expands from Uber Eats to Uber Stem Cells?
I’ve seen stem cell clinic ad after ad pop up in the mainstream media in my own hometown in The Sacramento Bee paper, but others are sprouting as well and a friend sent me a particularly striking stem cell advertisement from a recent copy of the San Francisco Chronicle.
Even as some unproven, for-profit stem cell clinics promote themselves aggressively in many ways including now on TV, on the flip side lately we’ve seen more TV journalists covering questionable marketing by the clinics and negative patient outcomes.
