Can California stem cell clinics make questionable marketing claims about their experimental, non-FDA approved offerings as long as they are not demonstrably false?
Do such clinics not bear any legal requirement to provide informed consent to patients?
A new court ruling raises such striking questions.
San Diego stem cell clinic Stemgenex sells non-FDA approved experimental stem cell offerings to patients suffering from a variety of conditions and last year a lawsuit was filed against the clinic on behalf of some of their customers. The proposed class suit included a number of allegations and much of it is centered on how the clinic marketed its offerings online on its website. The screenshot above from some months back, for instance, seems to claim 100% patient satisfaction.
A judge has now issued a mixed ruling that part of the lawsuit against Stemgenex can continue, while most other parts cannot. For three different takes on the court ruling see what appears to be a Stemgenex PR here mostly claiming victory, a blog piece by Harvard Law Professor Rebecca Tushnet here, and an LA Times piece here by Michael Hiltzik.
The key take home messages from Hiltzik on the overall ruling:
“Judge Antony J. Battaglia dismissed several claims brought by three former patients at the clinic, including an allegation that Stemgenex has misled patients because it has produced no evidence that its treatments have any scientific basis. He said it’s unclear that the plaintiffs would be able to show that Stemgenex’s representations about the effectiveness of its treatments are “actually false or misleading” because they haven’t shown that the clinic’s claims have “actually been disproved.”
But he allowed the case to proceed on grounds that Stemgenex misrepresented customer satisfaction statistics on its website. The clinic claimed 100% patient satisfaction, even after the plaintiffs themselves complained that they hadn’t seen any improvement in their medical conditions.”
Therefore, as to claims of 100% patient satisfaction, the case can proceed, but most of the rest of the case at least at this point is out.
Aspects of the judge’s ruling are concerning such as this statement:
“False-advertising claims based on a lack of substantiation, rather than provable falsehood, are not recognizable under the California consumer-protection laws.”
Is it then the case based on California law that consumers here at present can be recruited by dubious advertising by stem cell clinics and the state won’t protect them unless the advertising claims can conclusively be proven false?
It may be in this particular case that the plaintiffs did not present enough evidence to make such a claim here, but more generally the court language suggests a very high hurdle for challenges to stem cell clinic marketing and even medical marketing more generally. As to stem cells, context is important. In general, how does one prove a stem cell clinic’s advertising is definitively false when concrete information is hard or impossible to come by? Most clinics never publish their data, they generally won’t share their cells with independent researchers to test, and much of what they are doing is considered confidential.
Was Battaglia’s court aware of FDA broad warnings about stem cell clinics and offerings across the U.S.? The FDA rightly recognizes the potential of stem cells as the basis for new treatments but is very cautionary in general about what is being marketed directly to consumers already:
“the Food and Drug Administration (FDA) is concerned that the hope that patients have for cures not yet available may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful.
FDA cautions consumers to make sure that any stem cell treatment they are considering has been approved by FDA or is being studied under a clinical investigation that has been submitted to and allowed to proceed by FDA.”
That’s strong language in past years from the FDA, but since the FDA has not really subsequently backed this talk up with actual actions related to stem cell clinics marketing non-FDA approved offerings (such as the 100+ clinics here in California), how seriously do people take the language alone? I would hope a court would take it seriously, but it’s hard to say and the lack of FDA action puts more pressure on states and the civil courts in a sense to potentially oversee stem cell clinics. Are states and courts adequately prepared to do so? I also wonder if Battaglia’s court read new 2016 ISSCR guidelines that raise issues regarding stem cell clinics.
Another section of the court statement remarkably suggests that in its view of California law that patient informed consent may not be required by stem cell clinics:
“…the stem cell treatments are at least ‘reasonably related’ to maintaining or improving the health of a prospective customer and do not constitute ‘pure research’…to the extent that stem cell treatments represent a fairly newer body of research and development, the court does not find the innovative nature of the treatment to rise to the level of requiring informed consent under the Code.”
This blows my mind as a scientist, but maybe as a matter of law it is accurate? Maybe not?
What the clinics are doing is highly experimental in most cases and it seems to me that proper consent must be obtained or patients will be at much greater risk. The clinics themselves sometimes outright state that they are doing experimental research and they get their offerings listed on clinicaltrials.gov. They seem to like to think of and portray what they are doing as clinical trials. How can consent not be required in such a context? Is it because of some idiosyncrasy of California law on consent?
The court’s language suggests that California stem cell clinic patients in general may get the worst of both worlds right now as paying research subjects subject to questionable advertising for unproven experimental offerings who nonetheless mostly are without some key state protections. This ruling seems to temporarily create or at least highlight some big potential loopholes that could transcend this one fascinating case.
you see i wonder your stem cell really can help patient like me who is suffering PBP which is progressive bulbar palsy tks and what is the cost sir can i know tks so by the way how is the legal case going on now
@Bill
I have read your cited study, now. Really interesting data. Of course i am no stem cell advocat. I have alread learned here to be sceptical. I just would like to know if it may could work.
The data concerning meniscus treatment is certainly an argument against Regenexx and its stem cell therapy. But the question is, is the therapy not suitable for just meniscal treatment? Or maybe is there maybe a better outcome for cartilage repair? Or is this treatment not suitable at all?
@Bob
Of course there is no evidence and it is not proven by a single study,too. But there are many small studies and case reports. I have not read all, but most I read show encouraging results.
All in all Dr. Centeno has summarized all documented applications and so there is a number of more than 8000 participants.
So in my opinion he is right to say: “So the next time someone tries to tell you that we have little research on bone marrow stem cell use in orthopedics, just quote that number.”
Of course again: no double blind study, no evidence, but this big data is a good sign and of course much more than “meaningless”.
“If I give 1000 patients stem cells when they break a finger and all repair the break – you’re saying the stem cells did it? No control – no proof of efficacy is possible.” I am sorry, but this is not a good example, because modern medicine is able to heal broken fingers, but stem cells in orthopedics and in the above mentioned studies should heal damaged cartilage, avascular necrosis and meniscal tears without surgery – all illnesses or conditions modern medicine is not able to heal without surgery.
I am not sure, if the stem cell therapies in the orthopedics really keep their promise. I am only interested to get this question answered. But in my opinion so much data (more than 8000 documented applications with statistically good outcome) seems to be a good and strong sign for the efficacy of these methods, not more.
I hope some day anybody will do a big double blind trial to answer this question definetly, Until this will be done, we don’t have more than this summary of observational studies with limited relevance.
Your argumentation is self-contradictory. “Of course there is no evidence and it is not proven by a single study” – and – “many small studies and case reports…show encouraging results” These are correct, but the latter does not overcome the former. You still need proof – so what is proof?
The example I gave is perfect – but you must consider it in isolation not by adding information to defuse the question. Try again without adding other information (and replace broken finger with meniscus damage and replace stem cells with drug X). Now – does drug X repair meniscus damage – or did it heal by itself or was it both or was it something else, like diet or physio? The point is that without appropriate cohorts and sufficient numbers in the SAME study – you cannot make a call.
Imagine you are making a decision for state healthcare or a health insurer to cover costs of treatment and you get the example of 8000 n=1 cases with no controls and no peer-review – in fact the only review you have is from the clinic that sells it (!). Are you going to cover these costs with this data alone?
The above argumentation is embedded in something called the scientific method (https://en.wikipedia.org/wiki/Scientific_method) – without an understanding of this you will never be able to sort out the truth from the advertising.
Yes, thanks, you are of course right, but the problem is nobody is doing such a study and so we never will get clarity.
But there is a little difference to your example, because Regenexx says their stem cell therapy is suitable to heal damaged cartilage. Otherwise until today there is no therapy which could heal cartilage defects without surgery. So even n=1 case reports about cartilage healing seem to be a success.
All in all it is really a pity that there is no clinic which is interested in doing this study and to give a substantial answer.
“…because Regenexx says…” Seriously? I really recommend that you spend some time reading about the scientific method and how this delivers support for a hypothesis or nullifies it. Currently you don’t seem to be able to distinguish between credible scientific experiment and advertising.
@Bill, Bob
Of couse the summarized “studies” are all very small and have not many application, but if you take a look inside single studies you can read about good results:
For example just take the last one:
“The intra-articular injection of three consecutive weekly doses of ex vivo expanded autologous BM-MSC to patients with articular cartilage defects in the hip and proved to be a safe and clinically effective treatment in the restoration of hip function and range of motion. In addition, the statistical significance of the above data is in line with the observation that the radiographic scores (Tönnis Classification of Osteoarthritis) of the damaged leg(s) remained without variation in 9 out of 10 patients, after the administration of the cell product.”
All in all there is of course no double blind study and no evidence, but a good sign for efficacy because of the summarized number of patients.
“proved to be…clinically effective” How can a single study prove clinical efficacy with no control to compare to? It cannot.
“a good sign for efficacy because of the summarized number of patients” – absolutely wrong.
If I give 1000 patients stem cells when they break a finger and all repair the break – you’re saying the stem cells did it? No control – no proof of efficacy is possible.
It’s what you call “anecdotal data” and is meaningless for a clinical efficacy conclusion.
According to this study, surgery patients and sham surgery patients both had about a 50% reduction in pain after 12 months. See Figure 2C
http://www.nejm.org/doi/full/10.1056/NEJMoa1305189#t=article
Regenexx had about 55% pain reduction after 12 months, which is almost exactly the same as the sham surgery patients in the study above.
http://www.regenexx.com/wp-content/uploads/2014/01/RegenexxSD-Knee-Meniscus-2014-Registry-Data-v4.pdf
I wonder if this means that Regenexx treatments are no better than placebo?
Bill Jones I tried Regenexx for 7K and it did nothing.
just take a look at this amazing blog post by Dr. Centeno. I remember we have had a very interesting discussion about these stem cell application in the orthopedics.
Now Dr. Centeno has summarized data of 8596 applications.
https://www.regenexx.com/2017-orthopedic-bone-marrow-stem-cell-research-infographic/
Why “amazing”? Go back far enough, you’ll find hundreds of thousands that said their illness was caused by witches and their cures by the church, But no proof, no evidence-based rationale, no control cohorts, no peer-review. Amazing – or meaningless?
Thanks for the detailed information about the case. I want to be sure I understand. The judge said that the clinic’s claims have to have “actually been disproved.” What ethical physician is going to treat patients with adipose cells in order to show that the cells DON’T work? It’s not how science works.
The ethically right thing to do is for StemGenex to follow up on their own subjects and report cases in which their treatment did NOT work.