How quacks sell dubious stem cell therapies

Over the years, I’ve written quite a few times about dubious stem cell clinics and the treatments they offer. One time, I even managed to earn the ire of Keith Olbermann for questioning whether an anecdote involving the use of stem cell therapy to treat hockey great Gordie Howe’s severe stroke and the credulous reporting on it that basically swallowed the claims of Stemedica (the San Diego stem cell company that provided the stem cell treatments in one of its Mexican partner’s clinics, basically as a publicity stunt) and the Howe family, whose hope appeared to me to have blinded them to the reality that the stem cells probably very likely didn’t help him. I’ve documented families going down the road of too many families trying to raise money to pay for stem cell therapies, bankrupting themselves if necessary, as families have done for cancer quackery and other forms of pseudoscientific medicine. I’ve talked about stem cell therapies for autism, locked-in syndrome, and a wide variety of other conditions for which there is no evidence for their efficacy. I’ve discussed stem cell tourism, in which quack stem cell clinics set up shop in countries with—shall we say?—laxer and more permissive regulations (more so even than US regulations), where stem cell quacks can basically do anything they want, damn the consequences and the harm to patients.

More importantly, I’ve noticed that more and more reporters and government agencies are taking note of just how poorly regulated stem cell treatments are. For instance, Gordie Howe, as I pointed out, was enrolled in a dubious stem cell trial in a dubious clinic in Mexico by a dubious company that does run trials in the US but shunts patients who don’t qualify to its Mexican affiliates, which are not well regulated at all. Despite the FDA, even right here in the good U.S. of A., there are plenty of quack stem cell clinics using unethical hard sell techniques to recruit patients. Many are in Florida. Some have even run scientifically worthless clinical trials listed on ClinicalTrials.gov as an advertising tool to attract paying patients. In this, they’re basically following a trail blazed by cancer quack Stanislaw Burzynski, with devastating consequences. True, the FDA has made a move recently to crack down on these unregulated stem cell clinics, but it remains to be seen how much of an effect that the FDA’s interest and change in policy will have on the stem cell business. Certainly it would be good for lawyers.

Perhaps the scariest aspect of all this stem cell quackery is that real quacks, like naturopaths, have entered the stem cell field in a big way. As I put it at the time, if physicians who don’t know what they’re doing administering “stem cells” is scary, imagine how much scarier it is for alternative medicine practitioners like naturopaths to be selling stem cells. Well, Tim Caulfield did, and while I was otherwise occupied last week with my day job to the exclusion of the blog, he and his collaborators published a study in BMJ Open, Exploiting science? A systematic analysis of complementary and alternative medicine clinic websites’ marketing of stem cell therapies. The objective was to identify the frequency and qualitative characteristics of stem cell-related marketing claims made on websites of clinics featuring common types of complementary and alternative medicine practitioners and to explore the extent to which alternative medicine practitioners are involved and collaborate with medical professionals. They did this through a systematic website analysis of English language websites offering stem cell therapies.

The researchers set the stage in the introduction:

Stem cell research has considerable clinical potential and scientific discoveries continue to advance our knowledge in this field. Yet, despite enthusiastic media coverage of the field only a few stem cell-based therapies are currently ready for clinical application. This reality has not stopped the proliferation of clinics around the world advertising a wide array of unproven stem cell-based interventions. Many of these clinics use a direct-to-consumer marketing system based on an online presence.10 11 While much of the early growth in the commercial market for unproven stem cell-based interventions occurred in Asia, it is currently spreading to jurisdictions throughout the world. Furthermore, complementary and alternative medicine (CAM) practitioners have begun to offer stem cell-based interventions, marking a further expansion of this market.

Many of these interventions are marketed despite lack of approval by relevant regulatory bodies like the US Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research. The market also continues to flourish despite denunciation by research bodies like the International Society of Stem Cell Research,5 cautions issued by professional societies14 and legislative attempts to constrain it, among other efforts. The apparent resilience of this market suggests regulators and policymakers need to explore diverse approaches for addressing the various concerns associated with it.

“Resilient” is a good word. No matter how little evidence for stem cells for the specific conditions being treated, no matter how much government regulators try to crack down, somehow stem cell clinic operators stay in business. There is, after all, lots of money to be made. Recall that Gordie Howe’s stem cell therapt would have cost him $30,000 had Stemedica not made it available to him for free. Many stem cell clinics charge $10,000 or more a pop for each stem cell treatment, and many times multiple treatments are “required.”

As much as I like Caulfield, I am going to tweak him a bit over this passage:

The ways in which CAM practitioners (as well as interdisciplinary clinics featuring CAM practitioners) use stem cells to market their services and the nature of the claims they are making are understudied. Given the trend of CAM practitioners framing themselves as primary care providers,21 22 and their tendencies to offer unproven interventions,23 we hypothesised that such practitioners have begun to offer unproven stem cell therapies and that they might make potentially misleading marketing claims about them.

Here’s the minor tweak: That’s what we in the biz like to call a “Well, duh!” hypothesis, one that’s virtually certain to be true because it’s so obvious. That doesn’t mean it’s not worth studying. Indeed, I agree with Caulfield that it’s worth knowing how many alternative medicine or “integrative medicine” clinics are offering unapproved stem cell therapies, what kind of claims they are making, and how often. I wouldn’t have framed it as a hypothesis-testing study, though. I would have simply said what it is: An observational study. We know some clinics with naturopaths and other alternative medicine practitioners are, with or without real physicians, offering these therapies. I’d have just said that I wanted to know how many. There’s nothing wrong with that.

That is, however, a minor complaint and arguably a matter of style more than anything else. In order to attack the question, the investigators undertook Google searches with personalized results turned off using a number of search terms relevant to alternative medicine practitioners and stem cell treatments, such as:

• naturopath stem cell
• acupuncturist stem cell
• homeopath stem cell
• chiropractor stem cell
• midwife stem cell
• natural stem cell
• alternative stem cell
• holistic stem cell
• complementary stem cell

I would have included “integrative stem cell”” myself, because a lot of these sorts of clinics refer to themselves as “integrative medicine” clinics. That’s the new lingo. It’s hip, it’s happening, and “complementary and alternative medicine” (CAM) mavens are trying very hard to lose the word “alternative.” Not including that search term was definitely an oversight. Be that as it may, the above terms represent a good sampling of the sorts of clinics likely to be offering alternative medicine and stem cells.

The websites found, after duplicates and clinics not actually offering stem cell treatments were weeded out and analysis to see what sort of alternative medicine practitioners were offering stem cell therapy, were then subjected to content analysis:

A coding frame—that is, a framework for analysing specific language content on the websites and converting it to numerical data for analysis—was developed using both inductive and deductive methodologies, and content analysis was then performed. The coding frame is summarised in box 1. Coding of the websites was undertaken between February 2017 and May 2017. Initially, each web domain was manually searched to determine the country in which the clinic was located, as well as the type(s) of practitioners advertised (eg, naturopath, midwife, medical doctor). Subsequently, domain-specific Google searches were undertaken in the form of ‘stem cell site:URL’, to identify all mentions of stem cells in each domain. Coders then applied the coding frame to the domain by analysing all webpages linked from the Google search results. Excerpts were copied to note examples of the statements and claims present.

The investigators found 368 web domains, of which 243 marketed stem cell therapies and 116 marketed other treatments in whose description of treatment or effects (e.g., stem cells were “activated” or “stimulated”). Prolotherapy and platelet-rich therapy were included. Caulfield and colleagues found that many websites advertised stem cell transplantation from multiple sources, such as adipose-derived, bone marrow-derived, blood-derived, umbilical cord-derived and others. The also noted that “plant stem cell-based”” treatments and products (eg, skin creams) were also advertised.

Some examples are included, but one stopped me cold: Martha DeMarco’s website. The reason is that she’s a homeopath. It wouldn’t surprise me if there are no stem cells in the treatment, because homeopaths believe that diluting things make them stronger. (I know, I know, it’s the obvious joke, but ho can resist when it’s homeopathy?) In any event, these clinics offered stem cells for the usual litany of conditions: aging, musculoskeletal pain/injury, sexual enhancement, chronic obstructive pulmonary disease, congestive heart failure, cancer, and the like. Depressingly, the majority of the clinics were located in the US. Also:

Also, despite using CAM-focused search terms and not searching specifically for medical doctors, over half of the web domains marketing stem cell therapies featured medical doctors (130). Also, 66 of the 368 websites featured medical doctors along with at least one CAM practitioner. Other common practitioner types included chiropractors (53), naturopaths (44) and acupuncturists (20).

But what about the actual claims made? You won’t be the least bit surprised:

A low percentage of the domains advertising stem cell therapies stated that there was limited evidence of efficacy of the interventions (18.93%) or that there was evidence of inefficacy (12.76%). Only some domains mentioned general risks associated with an intervention (such as the small risk of infection or allergic reaction from injecting a substance with a needle) (24.69%), and even fewer mentioned risks specific to the mode of therapy (such as the potential to cause further damage to a joint by injecting cells into it) (5.76%). A minority of domains mentioned the regulatory (eg, FDA) status of the intervention (30.86%), and only 33.33% noted that the therapy is experimental or unproven. Hype language, defined as exaggerated or extreme language when speaking about potential benefits (eg, breakthrough, revolutionary, cure, incredible, amazing, magical) was found on 31.69% of the web domains offering stem cell therapies. See table 6 for greater detail on the disclosures made on the web domains and for examples of excerpts.

So what we have here is a picture of clinics that don’t tell the truth. They regularly don’t point out that there is little or no evidence for the efficacy of their treatments. They regularly don’t mention potential risks and adverse reactions. They often don’t mention that a treatment is experimental and not FDA-approved.

In the discussion Caulfield notes that the authors were “surprised that medical doctors were still the most common practitioner type noted.” He shouldn’t have been. Thanks to the infiltration of “integrative medicine,” with doctors who’ve gone to the dark side of woo or with doctors teaming up with alternative medicine practitioners. Basically, there are lots of physicians who, in addition to practicing some real medicine, offer treatments like acupuncture, herbal medicine, cupping, and more. He is correct to not afterward that their “results highlight again the critical role the medical community and its regulatory bodies, such as medical colleges, have in ensuring physicians are not engaging in unprofessional conduct with respect to their clinical or marketing practices.” And it’s true. The whole model of quack stem cell clinics is unethical, particularly those using hard sell techniques.

Caulfield and his co-authors are also correct to warn about how these unproven stem cell treatments have the potential to harm patients and damage the reputation of emerging science of stem cells. In fact, I’d go beyond that. the reputation of stem cell science is already so tarnished by all these quacks using it as part of their quackery or using the hype around stem cells to market other quackery that I don’t know how it can recover.