Only a few stem cell therapies have been shown through clinical research to be safe and effective for treating medical conditions, mostly cancer and blood and immune disorders.
Yet, that hasn’t stopped a growing number of clinics across the United States — including some here in Minnesota — from marketing unapproved stem cell therapies for a long and widely diverse list of other conditions, including aging skin, sports injuries, sexual dysfunction, autism, dementia and multiple sclerosis.
A study published last week in the journal Cell Stem Cell shows just how pervasive these clinics have become. Using Internet key-word searches, Leigh Turner, a bioethicist at the University of Minnesota, and Paul Knoepfler, a stem cell researcher at the University of California, Davis, identified 351 companies that are engaging in direct-to-consumer advertising of stem cell therapies at 570 individual clinics across the country.
Those numbers are probably on the low side, say the researchers, for it’s unlikely that all clinics offering unapproved stem cell “treatments” advertise that fact online.
Serious ethical issues
Turner and Knoepfler do not charge that the clinics they identified in their study are operating illegally, but do say that the Food and Drug Administration (FDA) and other regulatory bodies need to increase their oversight efforts.
“We are particularly concerned that we found many advertising claims related to [amyotrophic lateral sclerosis (ALS)], Alzheimer’s disease, Parkinson’s disease, and many other conditions for which there is no established scientific consensus that proven safe and efficacious stem cell treatments now exist,” the researchers write.
“The best way to address ethical, legal, and scientific issues related to such businesses is to acknowledge their existence, examine and evaluate their marketing claims, and conduct public debates and policy discussions in the most evidence-based manner possible,” they add.
To delve deeper into the implications of the study’s findings, MinnPost spoke with Turner on the phone late last week. The following is an edited transcript of that interview.
MinnPost: Were you surprised by the number of U.S. companies and clinics you found that were engaged in direct-to-consumer marketing of unproven stem cell treatments?
Leigh Turner: I was. I would have picked a much lower number. Those seem like really high numbers to me.
MP: How do your findings affect the idea of “stem cell tourism”?
LT: If you look at the academic literature or media coverage, the core story has been — at least in the United States — that an American makes the decision to go to Mexico, India, China, Ukraine or somewhere else to what’s often described as an “international stem cell clinic,” where they have an intervention of some kind. It’s not so much that that story is over. It’s just that it’s not quite accurate. If you’re here in the United States, you don’t have to go across the border to Mexico to find a clinic that’s making claims about stem cell interventions. If you live in California, there are an extraordinary number of businesses you can go to [113], or in Florida [104], Arizona [36], Texas [74] — really, all across the country. Although these businesses seem to cluster in certain places [Beverly Hills, Calif., has 18, for example, and New York City has 14], they are pretty spread out.
MP: There are about half a dozen here in Minnesota.
LT: Yes. We did find some in Minnesota. That surprised me as well. We found a lot of these places in Florida and California, but they were pretty close to home as well. I had no idea of that when we started [the study].
MP: What exactly are the stem cell interventions that are being marketed through these businesses?
LT: That’s a great question. What are patients actually having administered to them? What is actually going into their bodies? Are individuals even truly receiving stem cell interventions? And is there any reason to think that it’s safe? My co-author and I can’t really answer those questions because we were looking only at the marketing claims these businesses made on their websites.
One of the things we spent a lot of time looking into were the claims about the kinds of cells the businesses said they were using, as well as the claims they were making about the diseases, injuries and conditions that they said they could treat. A great many companies market autologous stem cells. Autologous means that when a patient goes to one of these clinics, tissue is removed from that person’s body. Often, it’s fat tissue from someone’s belly or abdomen. Or it might be bone marrow. [The cells are] then processed, and [injected] back into the individual.
We found other clinics making claims that weren’t [about] autologous cells. Some businesses market claims about amniotic products — amniotic fluid, amniotic tissue. We also found marketing claims about embryonic stem cells. One clinic made marketing claims, quite remarkably, about pluripotent stem cells [adult cells that have been genetically re-programmed to act like embryonic cells].
We also found two businesses that were advertising bovine [cow] stem cells. Those would be cross-species stem cell transplants.
MP: You found that these treatments were being marketed for 35 different conditions. That seems to be a red flag right there.
LT: There are different businesses out there in the marketplace. Some are what I would call “boutique” stem cell clinics. They are operating, say, a cosmetic surgery clinic, and maybe they have a bit of a sideline where, in addition to doing cosmetic surgery procedures, they’ll advertise things like stem cell facelifts, stem cell breast augmentations or stem cell buttock augmentations. Then you have quite a lot of orthopedic and sports-medicine facilities. They may pitch themselves as a stem-cell center, or it could also be a run-of-the-mill orthopedic clinic or a sports medicine clinic that is also making marketing claims about stem cells.
The clinics that most concerned us — that really got our attention and raised a lot of very serious ethical and regulatory issues, as well as concerns about patient safety — were the ones offering what looks like an awful lot of stem cell panaceas. These clinics will have a long list of conditions [that they treat]— neurological, immunological, cardiac, ophthalmologic, orthopedic, cosmetic, sexual enhancement. The list goes on and on and on. They may have the cosmetic component, or they may have the orthopedic component, but they also claim to offer “stem cell treatment and therapies” — and that’s their language — for ALS, multiple sclerosis, Parkinson’s disease, Alzheimer’s, dementia, autism, cerebral palsy, spinal cord injuries. Those strike me as the most problematic and the most deserving of close scrutiny by regulatory bodies.
MP: What are the potential risks associated with these treatments?
LT: If you think about the kinds of harms that can flow from going to clinics of this kind, the most obvious worst-case scenario is having a fatal outcome. There is a clinic in Florida, for example, where a doctor lost his medical license after treating patients with stem cells, and two of the patients died. Then you can have things like complications, injuries — say, a cell mass where you don’t want it or the cells are not the kinds that you want. Or you can have an infection or fever — not the worst kind of outcome, but also not a desired one.
And then you’ve got things like financial harm. If you have a very serious health problem — perhaps, you’re near the end of your life and you have limited life savings — when [a stem cell clinic] takes $15,000 or $20,000 dollars from you, I think we can think of that as a harm. Also, offering false hope, which then becomes dashed hope — that can be a harm.
And what if somebody is going to a clinic to get a treatment that they think is safe and efficacious, and then, after they spend their money, they find that they haven’t really seen significant improvement, so they look for a well-designed clinical trial that they could become part of? There’s a very strong likelihood that the [clinical trial’s] exclusion criteria will say that, well, if you have already had a cell-based therapy, you can’t be part of this study because that will be a confounding factor.
MP: What kinds of questions should people be asking? What are the warning signs?
LT: Patients and their loved ones can do things to try and protect themselves from the most predatory corners of the marketplace. If you see a business that’s offering one type of stem cell procedure for 20 or 30 different diseases, I would say that is a significant warning sign. If it’s a business where a person is making claims about being an individual with a background in stem cells, but it’s basically, say, a cosmetic surgeon who’s done no meaningful stem-cell research of any kind but is just making promotional claims about it, [that’s another warning sign.]
The International Society for Stem Cell Research [ISSCR] and other organizations have spent a lot of time trying to help patients and patient advocates think about what to look for. They tend to focus on clinics outside the United States, but a lot of their guidance applies to businesses inside the United States as well.
The problem is that this imposes a lot on patients. The challenging thing about many of these businesses is just how compelling and credible they look. When you go to the websites, they look like credible businesses. All of the marketing and promotional rhetoric looks quite persuasive. Sometimes, for example, you’ll find testimonials. People will tell stories about how bad things were for them and how great things are now because they’ve had the stem cell procedure. Also, you’ll sometimes find links to articles in the scientific literature, which makes it look like there’s a scientific basis for what’s being done. It’s only when you look carefully do you begin to realize that, oh, this is an article that’s about stem cells that were administered in rat models, or it’s pre-clinical research. It has nothing to do with [the treatments being offered by the clinic]. It has nothing to do with these doctors. It’s just trying to confer legitimacy on what those businesses are doing.
MP: So it’s caveat emptor.
LT: I would say that it’s important to have a public conversation that isn’t just about caveat emptor — that doesn’t just say to people, “You’re on your own, so good luck.” I think we need to ask tough questions about why we aren’t seeing more regulatory activity by the FDA, by the [Federal Trade Commission], by state medical boards, by consumer protection agencies. Why is it that so much of the burden seems to fall on the shoulders of patients, many of whom are already suffering from serious health problems? Why aren’t we seeing these other kinds of bodies do what they’re legally empowered to do — clamp down not only on the marketing claims but also on the manufacturing and sale of these unproven interventions?
There is an awful lot that regulatory bodies could do. And, yet, the FDA has issued very few warning letters. That raises the question: Why don’t we see more effective regulatory activity by the FDA? The entire marketplace has exploded in the United States, and we have the most relevant federal agencies standing on the sidelines, for the most part.
MP: Why do you think they’re not acting?
LT: It’s a really perplexing question. One thing is that the FDA has regulatory authority over a significant part of the U.S. marketplace. A great deal is asked of the FDA, and many people would say they are not given the resources they need to do what they are legally mandated to do. Maybe the FDA needs more funding for the FDA center that is responsible for dealing with these kinds of businesses. Maybe they need more resources to develop a database like the one we created and to pay more attention to marketing claims. Maybe they need more inspectors who can go on site and do the inspections.
The FDA will claim that they have to make difficult decisions about allocating their resources, that they have to prioritize their efforts, and yet the FDA has issued [plenty of] warning letters to cosmetic companies marketing one or two cosmetic products that are just being applied to people’s bodies. Meanwhile, there are businesses that are injecting or infusing stem cells into what seem to be substantial numbers of patients in 30 or 40 disease categories, and no one from the FDA seems to be showing up on their doorstep.
MP: You raise ethical concerns in your study about how many of these patients are quite vulnerable, particular children and adults with dementia.
LT: Some people say that adults should be able to make their own decisions [about stem cell treatments]: They’re autonomous, so get the FDA out of the way and let people take on any level of risk that they want. That kind of glib remark doesn’t take into consideration that these businesses target interventions to children, who do not have a decision-making capacity, and to adults who may have cognitive deficits, memory loss or other neurologic conditions that mean we shouldn’t be assuming they have decision-making capacity. So, yeah, there is some concern that some businesses are targeting individuals who we think of as being unable to provide informed consent.
But I would also say this: Are you truly making autonomous choices if a business is making misleading marketing claims? If it’s making exaggerated marketing claims? If it’s providing reassurances that something is safe and there’s little or no risk of complications when they haven’t done the clinical research that provides conclusive evidence of efficacy or safety?
When information is packaged and torqued that way, when it’s framed that way, that strikes me as being closely bound up with people’s decision-making.
FMI: Turner and Knoepfler’s study can be found at the Cell Stem Cell website. For detailed patient-focused information about stem cell therapies, including a list of questions you should ask of anyone marketing such therapies, go to the ICCR’s website and read their “Patient Handbook on Stem Cell Therapies.”
It’s more sophisticated
…but it’s still snake oil that’s being sold.
The FDA (and the CDC) are both seriously underfunded, largely because a Republican-controlled Congress:
A) Hates regulation, whether the regulation makes sense or not;
B) Worships profit, which is usually diminished by A), above; and
C) Suffers from a wholly misplaced faith in a nonexistent “free market” wherein consumers of health-related services are easily able to make informed choices.
A, B and C are interrelated, and go far to explain why our health care system is the world’s most expensive (though not “the best”) while producing results that qualify as mediocre.