In this interview, Leigh Turner (University of Minnesota; MN, USA) discusses his recent review of Canadian businesses involved in direct-to-consumer marketing of purported stem cell interventions.
Read “Direct-to-Consumer Marketing of Stem Cell Interventions by Canadian Businesses” in Regenerative Medicine now.
Leigh Turner, PhD, is an Associate Professor at the University of Minnesota Center for Bioethics, School of Public Health, and College of Pharmacy. He can be reached by email at [email protected].
What prompted this research?
Many of my recent publications have investigated the U.S. direct-to-consumer (DTC) marketplace for unproven stem cell interventions but I’m a Canadian citizen and I’ve been tracking the emergence of Canadian clinics promoting purported stem cell therapies. It was just a matter of finding enough time to examine the Canadian ‘industry’ in a rigorous, systematic manner. I found some Canadian clinics promoting stem cell interventions back in 2015-2016 when I was conducting searches for a study investigating such clinics in the U.S. and I knew then that when I had the opportunity I would do a similar analysis of Canadian companies advertising and administering putative stem cell treatments.
I find it helpful to study both marketplaces in a comparative manner, examining similarities, differences, and how they connect to one another. Some Canadians travel to clinics in California, Florida and elsewhere in search of what they hope are effective stem cell treatments, some American companies have expanded into Canada, creating affiliate clinics or holding what they advertise as ‘educational seminars’ but what are in fact marketing pitches intended to draw Canadian clients to U.S. clinics, and some Canadian businesses have established ties with U.S.-based ‘stem cell clinics.’ It’s easier to investigate these relationships by studying the DTC stem cell marketplaces in both countries than by viewing them in total isolation from one another.
If the question is why study this topic rather than something else, it’s because I’m very concerned about the risks associated with businesses making dramatic claims about stem cell treatments for a wide range of diseases and injuries without doing the careful, costly, and time-consuming work needed to develop a compelling evidence base for such representations. Such direct-to-consumer marketplaces are typically fueled by hyperbole and inaccurate advertising claims. Often, such claims take advantage of human suffering as well as patients’ sense of hope that maybe effective stem cell therapies do currently exist for such diseases as ALS and Parkinson’s disease.
There’s a genuine risk that patients and their loved ones will be preyed upon by clinics making particularly egregious advertising claims. There’s also the possibility that patients will suffer serious harms as a result of undergoing stem cell interventions that do not fall within an evidence-based standard of care. And then there is the confusion and misunderstanding that exists as a result of companies blurring distinctions between established treatments and unproven, experimental interventions.
I’m not just interested in counting how many clinics in Canada or the U.S. sell purported stem cell treatments, though I do care about the empirical part of my research. But beyond trying to conduct empirical studies of DTC stem cell marketplaces, I’m very concerned about the ethical and legal issues generated by such commercial and clinical activity as well as their implications for health policy and health care systems.
Why do you think Canadian stem cell clinics have avoided the scrutiny that US-based clinics are often subject to?
It depends on what you mean when you refer to avoiding scrutiny. In terms of peer-reviewed scholarship and serious investigative reporting, U.S. clinics marketing purported stem cell treatments have attracted more critical scrutiny than their Canadian counterparts. There wasn’t much coverage of such U.S. businesses three or four years ago — for nearly a decade the rhetoric was all about ‘stem cell tourism’ to clinics based in such countries as China, India and Mexico — but recently the quality and quantity of academic research and news media coverage examining the U.S. DTC stem cell marketplace have increased.
The Canadian DTC marketplace for stem cell interventions has attracted the attention of some academics and journalists — my paper mentions contributions others have made — but to date this topic hasn’t emerged as a significant national science or health policy issue. Maybe my study will help draw attention to some of the risks associated with clinics making claims about ‘stem cell treatments’ that aren’t backed by conclusive evidence of safety and efficacy. Then again, perhaps it will take a tragedy of some kind — a highly publicized fatal outcome or news media coverage of seriously injured patients, as has happened in the U.S. — for Canadian legislators, regulators, policy-makers and other parties to better understand why such businesses need to be subjected to stringent regulatory oversight.
However, if you are referring to scrutiny by federal and provincial or state regulatory bodies, then I would argue that to date most Canadian and U.S. clinics marketing stem cell interventions have been subjected to little serious scrutiny. There are exceptions — the FDA has issued warning letters to some companies and is currently in federal court seeking permanent injunctions against two particularly egregious business operations — but for the most part Canadian and U.S. companies selling putative stem cell treatments have operated with little meaningful regulatory scrutiny.
Anyone with a naÃ¯ve faith that regulatory bodies provide scrupulous oversight of health care markets should familiarize themselves with the literature on DTC marketing of unproven and unlicensed stem cell interventions. It’s striking how little some regulatory bodies do, even when businesses flagrantly violate laws and put patients at risk of serious harm. Furthermore, absent meaningful regulatory oversight, the markets themselves do not somehow “self-correct” by weeding out bad actors.
You recently published research into public perceptions of ‘stem cell treatments’ amongst patients who are crowd-funding their treatment. Do you think Canadian patients perceive ‘stem cell treatments’ any differently?
There hasn’t been much research investigating how Canadian patients perceive purported stem cell treatments or the clinics marketing them. It’s possible that studies focused exclusively on Canadian patients would generate unexpected findings but my suspicion is that studies of patients in other countries provide at least some insight into how Canadians make sense of putative stem cell treatments.
Hope that such interventions will help them presumably draws some Canadians to clinics marketing supposed stem cell treatments, whether these companies are located in Canada, the U.S., or elsewhere. Desperation is likely a factor in at least some cases. It’s understandable that individuals diagnosed with ALS, dementia, or other degenerative diseases that at present are incurable go online and search for therapeutic options outside the current evidence-based standard of medical care.
Some Canadians perhaps think of themselves as savvy and informed consumers, able to make discerning choices and navigate the DTC marketplace. Others might think of themselves as participating in meaningful clinical research and advancing legitimate stem cell science, even if they’ve been charged thousands or tens of thousands of dollars to participate in so-called studies that are little more than marketing devices.
We need detailed analyses exploring just how Canadians perceive supposed stem cell treatments and the businesses that sell them but enough good studies exist on patients’ blogs, narratives of hope, and crowdfunding campaigns to provide some suggestions about how Canadians might make sense of stem cell interventions available for purchase in the DTC marketplace. Whether Canadians perceive such interventions differently than individuals in other countries is something that future research will have to examine. Maybe gender, socioeconomic status, educational background, health status, attitudes toward science, understandings of ‘alternative medicine,’ and other factors shape perceptions more than nationality.
During this research, what surprised you the most?
Among the various companies identified in my dataset and discussed in the article, there’s a business in British Columbia that advertises stem cell treatments for amyotrophic lateral sclerosis, muscular dystrophy, Parkinson’s disease, stroke, multiple sclerosis, asthma, COPD, congestive heart failure, myocardial infarctions and many other diseases and injuries.
The facility is an affiliate of a U.S. ‘network’ of clinics against which the U.S. FDA is in court seeking a permanent injunction. To date, there is no record of this business being the subject of regulatory action by Health Canada. Nor is there any public record of its clinicians being disciplined by the College of Physicians and Surgeons of British Columbia.
For me, this company prompts the question of what marketing claims and clinical activities does it take to trigger regulatory action by Canadian federal and provincial regulatory authorities? Given the breadth of advertising claims related to stem cells and given legal action by the FDA against the network of which this clinic is an affiliate, to some extent I’m surprised this business hasn’t already attracted the ire of Canadian regulatory bodies. Then again, I’ve spent enough time studying such companies to no longer be shocked when regulatory agencies are missing in action.
How did the Canadian clinics identified in this research compare to clinics identified in previous research, which tended to be based in the US?
There are many similarities between Canadian clinics marketing purported stem cell treatments and clinics engaged in such DTC activity in other countries. It’s standard to find most such clinics located in or near large cities, operating in close proximity to their target markets. It’s very common to see patients charged on an out-of-pocket basis because advertised stem cell products are not supported by conclusive evidence of safety and efficacy.
As a result, such interventions typically are not covered by public or private health insurers. While not all studies evaluate claims clinics make about risks and benefits, those studies that examine such representations typically find that clinics marketing stem cell treatments minimize risks and make strong claims about therapeutic benefits.
Canadian businesses fit this pattern of presenting information in a manner intended to reassure prospective clients that they can obtain access to safe and effective therapies. The emphasis on marketing autologous stem cell procedures is also fairly typical, though I’m now tracking more U.S. clinics marketing allogeneic stem cell products reportedly sourced from placentas, umbilical cords, or amniotic fluid than I was back in 2015 and 2016. Maybe such allogeneic products will become more common in Canada if such clinics continue to proliferate.
Of the 30 distinct Canadian businesses marketing stem cell interventions, 26 market them for orthopedic and musculoskeletal indications, 23 promote them for pain relief, and 14 advertise them for sports-related injuries. The dominance of such claims resembles the kind of claims made by comparable clinics in the U.S. Two Canadian companies make advertising claims that fall outside this general pattern. Of the outliers, one business advertises stem cell interventions for such conditions as ALS, Parkinson’s disease, multiple sclerosis, and stroke. The other company markets stem cell procedures for autism, MS, COPD, diabetes, and erectile dysfunction.
These Canadian businesses remind me of the many clinics in the U.S. and other international settings that market purported stem cell interventions for dozens of diseases and injuries. If Health Canada and provincial colleges of physicians and surgeons do not act to regulate businesses making such expansive claims, my guess is that more companies will enter the Canadian marketplace and make similarly broad claims about the diseases and injuries they can treat with stem cells. Regulatory inaction might also result in more Canadian businesses claiming they are conducting clinical studies approved by research ethics boards (the Canadian equivalent of what in the U.S. are known as institutional review boards) and charging patients thousands or tens of thousands of dollars to participate in supposed clinical research.
At present, I don’t see the Canadian DTC marketplace for stem cell interventions as out of control as it is in the United States. Then again, given the lack of action by federal and provincial regulatory bodies and the presence of 30 businesses operating 43 clinics at which purported stem cell treatments can be purchased, I see no reason to be cavalier about the current situation in Canada. The time for regulatory bodies to determine which cell-based products require pre-marketing approval, to clarify terms and regulations, and to act is before such marketplaces spiral beyond their control and patients suffer serious injuries or financial losses.
What lessons can or should Health Canada learn from the FDA in regulating these kinds of clinics?
Health Canada needs to learn from the U.S. FDA’s failure to provide meaningful oversight of the U.S. DTC marketplace for unproven and unlicensed stem cell interventions. Regulatory inactivity functions as a signal for businesses and entrepreneurs to pour into the DTC marketplace. It becomes obvious to everyone that large sums of money can be made with little fear of being subject to criminal charges for fraud, to license suspension or revocation, or to other serious penalties.
Over time, as such DTC marketplaces expand, what was once a relatively manageable regulatory challenge becomes a nearly impossible task as the number of businesses marketing unproven stem cell interventions overwhelms the capacity of regulatory agencies to conduct investigations and take meaningful action
My main message to Health Canada officials would be to look at the U.S. and understand how the Canadian DTC marketplace for purported stem cell interventions is going to expand at a rapid rate if Health Canada doesn’t claim regulatory authority over autologous and allogeneic stem cell products.
Health Canada needs to develop precise and narrow definitions of regulatory exceptions related to homologous use and minimal manipulation of stem cells. It also needs to engage in meaningful regulatory action when businesses require premarketing authorization from Health Canada for the purported stem cell therapies they advertise and yet lack such approval. Health Canada officials need only to look at the situation in such states as California and Florida to grasp what happens when businesses marketing stem cell interventions are not subjected to robust regulatory oversight.
What are your future research plans?
I plan to continue conducting empirical studies of businesses engaged in DTC marketing of purported stem cell treatments. I also intend to continue addressing ethical issues, patient safety concerns, and regulatory challenges related to such commercial and clinical activity. In addition to proceeding with this research program, I have a long list of projects I’d like to pursue, some related to stem cells and regenerative medicine, some connected to other longstanding interests such as cross-border travel for medical care, and some that would represent new directions for me.
Some academics transition into exclusively administrative careers after growing bored with research and writing. I don’t fall into that category. I’ve been fortunate to maintain the sense of curiosity, engagement, and enthusiasm that I think are crucial elements of conducting research, whatever one’s specific academic discipline or particular area of expertise. I’ve also had the good fortune to collaborate with some terrific colleagues in such countries as Australia, Canada, Japan and Singapore. I look forward to working with them in future as much as I’m excited about the specific projects I hope we’ll pursue.