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.
A list of stuff for your weekend reading enjoyment ranging from research pubs to news to commentary.
Human neural stem cells (green) guided by electrical stimulation migrated to and colonized the subventricular zone of rats’ brains. This image was taken three weeks after stimulation. JUNFENG FENG/UC DAVIS, SACRAMENTO AND REN JI HOSPITAL, SHANGHAI
FDA new post on its plans for guidance docs in 2017. Hmm, what does the part on tissue and advanced therapies relevant to stem cells mean exactly? Is no mention of the four draft guidances from past years related to stem cells and regenerative medicine a bad sign? Who knows?
And as a bonus, a very old, somewhat wacky and in-your-face post of mine on “Dr. No” and peer review of science manuscripts and grants. I still hate your paper….
New FDA Commissioner Dr. Scott Gottlieb, M.D., has in the past touched on stem cells and regenerative medicine therapies in speeches or written comments prior to starting his tenure at the agency. Now that he is Commissioner, he is poised to have direct impact on our field rather quickly and potentially with major changes in store.
How might that unfold?
In one of his first statements that includes stem cells and regenerative medicine as Commissioner, Gottlieb perhaps gave us some hints within a new blog poston the FDA siteentitled, “How FDA Plans to Help Consumers Capitalize on Advances in Science”.
Here is the part of his post related to stem cells and regenerative medicine:
“Our Center for Biologics Evaluation and Research (CBER) is implementing the Regenerative Medicine Advanced Therapy, or RMAT designation. This new process provides another pathway to access FDA’s existing expedited programs, and is available for certain cell therapies, therapeutic tissue engineering products, and certain combination products. The goal of these efforts is to help foster the development and approval of these novel products. We’ve already received almost two dozen requests for RMAT designation and granted four such designations to date. To continue to advance these opportunities, we’ll be announcing this September a comprehensive framework for the development and proper FDA oversight of regenerative medicine. This new policy effort will comprise a series of new guidance documents covering many aspects of the regulation of regenerative medicine products. It will be announced as part of our Innovation Initiative. It will delineate our policies for appropriate and efficient regulatory oversight of regenerative medicine products, in order to demonstrate their safety and effectiveness. It will also create an accessible framework that will enable providers to more easily collaborate on proving these principles for regenerative products that are advanced within local medical institutions. We want to help facilitate these scientific advances, which hold out tremendous potential for treating and even curing diseases. To achieve these goals, we need to make sure that we have a modern regulatory framework in place that can allow innovators to meet the statutory requirements for demonstrating safety and effectiveness.”
Can one read any tea leaves in there?
While we will have to wait until September to get more clarity, this text has some interesting tidbits. The first thing that jumps out at me is the rapid timeline in terms of CBER having new, hopefully clear frameworks by September (that’s only 2 months from now) on specific types of regenerative medicine. I see that as a positive. Second, the concept of an “accessible framework” suggests perhaps the FDA will include guidances (finalized or draft at that time?) that are clear to the public and to a diverse group of stakeholders, and hopefully include concrete examples of various scenarios. For instance, are fat stem cell products like SVF by definition biological drugs? If sometimes not, will that depend on their homologous use? What about non-homologous use of bone marrow products? Where do the amniotic products increasingly popular with clinics fit in here? I could go on probably with 20 questions.
Finally, the last sentence of the quote above has the verb “allow” as pertains to regenerative medicine practitioners, which struck me. The use of that verb suggests a smoother path at the FDA for accelerating investigative stem cell therapies perhaps also with a lower initial hurdle for entry into the FDA review process for investigators and their products. The stakes are big here. I’m very curious to see if the FDA’s new framework on regenerative medicine will hit a sweet spot of promoting innovation while not lowering oversight standards. That’s not an easy task. Whatever the framework, it’d be refreshing if CBER actively enforces its policies on stem cells and regenerative medicine in a prompt, consistent, and clear manner.
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.
Right-To-Try laws have been passed in many states across America, paving the way in theory for gravely ill patients to have the right to try unproven treatments of various kinds, and now there is a serious push underway for a national Right-To-Try law.
What is a Right-To-Try law?
Typically, these Right-To-Try laws allow for a patient facing serious illness, with consent of their physician and the business that makes the still investigational therapy, to not have to wait for full vetting of the new treatment. They can take the risk, for example, on a new chemical drug or stem cell-based regenerative medicine therapy before it is proven to work or definitely to be safe. For a patient with a fatal illness such as ALS, it seems reasonable that they should have a right to try different options, but it should be noted that the FDA already has a aktivitas for this kind of situation called compassionate use or as the agency calls it, “expanded access”.
On the stem cell front, one of the biggest concerns over Right-To-Try is that it could be exploited by some of the hundreds of stem cell clinics out there. The new stem cell law in Texas, which in an earlier incarnation as a bill I called “Right-To-Profit” for stem cell clinics, has some Right-To-Try elements. Another concern is that some proponents of Right-To-Try don’t want it limited to fatal illnesses.
Overall, the campaign for a federal Right-To-Try law is gaining momentum via a legislative push called the Trickett Wendler Right to Try Act. Yesterday, for instance, Sen. Ron Johnson (R-Wis.) released a statementsaying Right-To-Try should be included as part of the FDA reauthorization bill. Johnson is a sponsor of Trickett Wendler and has threatened to hold up FDA funding over this cause.
I asked stem cell scientist Sean Morrison, who is also the Chair of the ISSCR public policy committee, for his take on the push for a federal RTT law, particularly as it relates to stem cells, and here is what he said:
“1. These right to try bills are bad for patients because most of the new therapies patients will be able to access as a result of these bills would be expected to prove unsafe or ineffective once additional clinical testing is done. This is because we know that most therapeutics that seem successful in phase 1 clinical trials prove to be unsafe or ineffective upon additional testing in phase 2 and 3 clinical trials.
2. These bills are often introduced by well-meaning legislators who have very little understanding of medical research or clinical testing. They don’t realize these bills will victimize patients by opening the door to snake oil salesmen to sell unproven therapies to patients. Patients will be forced to make life and death decisions without the benefit of clinical data on whether the therapies are safe or effective.
3. These bills have been introduced nationwide as part of a general assault on FDA regulation. Most people who support these bills don’t realize that the FDA already has a very effective, and efficient, accelerated access aktivitas under which patients can get therapeutics prior to FDA approval. Most don’t realize the extent to which the FDA protects Americans from snake oil salesmen trying to make a buck by exploiting the hopes of desperate patients, by selling unproven and often scientifically implausible therapies that are promised to cure all manner of incurable diseases.
4. There are scores of companies in the United States who want to sell unproven and scientifically implausible stem cell therapies to patients, some of whom are among the main supporters of right-to-try legislation.”
It’s better than 50-50 that Right-To-Try will become federal law, but it’s not a done deal and if it does become law it isn’t entirely clear what the practical impact would be since state laws of this kind haven’t to my knowledge led to dramatic changes in terminal patient access to investigational drugs plus many drug manufacturers do not want their experimental treatments utilized in this manner for various reasons. For stem cells specifically, I expect that if there is a federal Right-To-Try law that we’ll start seeing “Right-To-Try” popping up in clinic advertisements, which wouldn’t help matters.
University of Minnesota bioethicist Leigh Turner has been threatened with a lawsuit by a stem cell clinic-related business. Threats in this arena come up every so often and as much as they are unpleasant realities, they can also reveal some important aspects of the stem cell arena. Ars Technica reported yesterday that Leigh’s recent paper on stem cell clinics and businesses associated with them with listings of non-FDA approved offerings in Clinicaltrials.gov was the impetus for the threat of a lawsuit and intention of asking for a retraction/correction.
An email to Leigh from Duncan Ross, the president of The Kimera Society (one of several organizations discussed in Leigh’s paper), included the reported litigation threat, which was quoted in Ars this way:
“I encourage you to amend your publication or I am going to bring suit against the institution for defamation or slander. I am going to lobby the journal for the retraction of this publication. I followed the letter of the FDA as it exists at this time and I am not going to have my name disparaged because of your lack of interest in due diligence…You continue to assume I’m being devious in some way and I’ve had enough.”
As someone who not only does stem cell research, but also writes about stem cell research and clinics, this struck me as an important development and I wanted to learn more about it. I asked Leigh for comment on this situation and he sent me his perspective along with his view of the larger context (you can read his full comment here):
“My article accurately states that the Kimera Society registered on ClinicalTrials.gov a pay-to-participate study in which adipose derived stem cells are administered to individuals with Chronic Obstructive Pulmonary Disease. The ClinicalTrials.gov listing does not disclose that study subjects are charged but this information is in the public domain and Duncan Ross, founder of Kimera, acknowledges that study subjects with COPD pay to participate in this study. My article also argues that studies involving administration of autologous adipose-derived stem cells to individuals with COPD appear to require an Investigational New Drug application that has been submitted to the FDA for review and cleared by CBER. In response, Duncan Ross has called for a retraction of my article and threatened that he will sue for libel or defamation if the article is not corrected or retracted.”
For balance I also asked Duncan Ross for a comment on this situation. I thought this was particularly important to do since Leigh and I have published work together, and share some concerns about direct-to-consumer marketing of stem cells. Here’s the comment that Ross emailed me for this piece:
Duncan Ross, Kimera Society
“My issue with Dr. Turner’s approach is this. Even in the case of your one page blog post, you chose to reach out to me to understand what I, personally, hoped to achieve and/or had done to support the publication of the trial. In fact, I had received IRB approval, whereas Dr. Leigh insinuates throughout his publication that no IRB approval is needed for publication on clinicaltrials.gov. By writing these types of sensational articles, without due diligence, he piques the interest of journalists. These journalists write an article based on a DRAFT guidance, not fully understanding what that means. Then in an email back and forth that I have limited time to attend to, I send only the 2015 approval. That get’s printed. In fact I renewed the IRB every year but didn’t care to continue my discussion with Leigh. What you end up with is someone with a non-scientific background, taking all his time to research and call out companies by name, making them look illegal when in fact I have been in contact with the FDA and done what they require AT THIS TIME. I stood up at the scientific meeting, not public, and suggested that there should be some mechanism to regulate stem cell clinics. There is none at this time. I would pursue it myself through my non-profit. SO failing a pathway, and if IRB approval is not good enough for Leigh, he is going to continue to run around half-cocked and telling half truths. If someone, and I suppose it is going to be me, does not highlight his wholly negative approach, then we might end up curtailing the positive clinical outcomes that the pharmaceutical industry is taking note of and working towards. In fact, my research and the direction of my company is wholly focused on exosome therapies now, a discovery that came out of my experience with these types of autologous stem cell therapies.
If you would like a big red box that says “paid trial’ on clinicaltrials.gov then lobby for its inclusion. If you would prefer stem cell clinics NOT get IRB approval, which I doubt you do, then state that to. I don’t see how choosing the only groups actually working through the requirements available to fulfill today is helpful or professional. Why not discuss the warning letters that were issued and how they were based in large part on sterility.”
Overall, there are hundreds of clinics and associated businesses marketing fat stem cell and other kinds of stem cell treatments for any of a whole medical encyclopedia worth of health conditions. Leigh and I reported on this in our paper in Cell Stem Cell last year. In my opinion, Leigh’s overall scholarship in this area is meritorious and has unique, positive impact. Even so, writing about stem cell direct-to-consumer businesses in any form whether it’s an academic paper or blog can be dicey.
In his comment to me, Leigh highlighted the possible impact that litigation threats can have:
“Mr. Ross’ threat is all-too-representative of the responses that emerge from individuals associated with businesses that charge patients for unproven stem cell interventions. When critiqued, they have a habit of attempting to threaten critics and intimidate them into silence. Such threats have a chilling effect on scholarship. In particular, they make academic journals and researchers wary of identifying businesses by name and critiquing specific commercial practices. The threat of litigation has impeded the ability of researchers to conduct research on such business and publish articles that address important ethical, legal, and scientific issues associated with their marketing claims, business practices, and clinical activities.”
However, one of the challenges for potential plaintiffs in such situations is that just the filing or even threat of a suit poses the risk of bringing them a hefty amount of often negative media attention a la “The Streisand Effect”.
Beyond the potential litigation issue, the Ars piece provides helpful background and new quotes from various parties including stem cell clinic leadership. One of the other interesting aspects of the Ars piece was that it got a meatier FDA quote on stem cell clinics than pretty much anything else I’ve seen from the agency in the recent past:
“We recognize that there are a number of clinics operating, which do not register with FDA. Consumers are encouraged to contact FDA and the appropriate state authorities in their jurisdictions to report any potentially illegal or harmful activity related to stem cell based products. We also encourage patients and health care providers to report adverse events associated with cellular therapies to FDA.”
Does this mean the FDA soon will actually do something concrete to bring more clarity and order to the stem cell commercial arena?
I doubt it, at least most likely not any time soon. We’ll see if as indicated in the new FDA Commissioner’s blog post the upcoming policy statements from the agency in September and then in later months might clarify the regulatory path forward for stem cell offerings such as adipose stem cells as well as other big issues such as non-homologous use and minimal manipulation. One of the rare areas of relatively greater agreement amongst many of the various stakeholders involved in or discussing stem cell clinic practices is the desire for more clarity and consistency from the FDA.
Will Kimera follow through and actually file suit against the University of Minnesota or Turner? If history is any guide, such threats almost always do not result in an actual lawsuit, but it’s possible. Regardless, I’d ask you readers a couple more questions: what is this situation telling us about the stem cell commercial arena today, and what risks and considerations are involved in being a public critic of specific commercial or other practices in the life sciences?
It’s definitely not for the faint of heart.
Note: This piece has been updated since its original posting with a few edits to reflect new information that arose in the comment thread including from Kimera’s Duncan Ross that Kimera may be more of a stem cell clinic-associated business (e.g. supplying cells to clinics) rather than a clinic itself.
The FDA took some big action last week and issued a major statement today on stem cell clinics (see my post here). I asked Dr. Mark Berman of the Cell Surgical Network if he had any statement regarding the recent action and statement from the FDA today that involved flagship network member clinic, California Stem Cell Treatment Centers.
Dr. Berman sent me the new press release from Cell Surgical Network, which you can read here.
Amongst other things, the Cell Surgical Network PR makes some strong statements that I’ve got as bullet points below:
The PR defended the work with StemImmune, which it said involved many top doctors.
The PR said that the Department of Defense was involved.
The PR said there was no charge to patients for participation in this particular interventional work. I’d be curious how it was funded then.
It mentioned “multiple IDE and IND applications” having been submitted, which is notable. What is the status of these at the FDA? Wouldn’t the work with StemImmune require pre-approval from the FDA in the form of an IND (not just submitted, but favorably reviewed by the FDA), BLA, and more before experimenting on patients? In my view, it sure seems that way.
The PR singled out FDA Commissioner Gottlieb, saying, “His comments show a lack of understanding surrounding autologous surgical procedures.” Really? That’s an aggressive statement in my opinion.
It said regarding Cell Surgical Network interaction with the FDA inspectors, “After sharing with and educating the inspectors as much as we did…”
In short, Cell Surgical Network is responding vigorously to the FDA with this PR.
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.
New FDA Commissioner Dr. Scott Gottlieb, M.D., 
Right-To-Try laws have been passed in many states across America, paving the way in theory for gravely ill patients to have the right to try unproven treatments of various kinds, and now there is a serious push underway for a national Right-To-Try law.
The FDA took some big action last week and issued a major statement today on stem cell clinics (