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Abstract
Objective 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. The involvement of complementary and alternative medicine practitioners in the marketing of stem cell therapies and stem cell-related interventions is understudied. This research explores the extent to which they are involved and collaborate with medical professionals. This knowledge will help with identifying and evaluating potential policy responses to this growing market.
Design Systematic website analysis.
Setting Global. US and English-language bias due to methodology.
Main outcome measures Representations made on clinic websites in relation to practitioner types, stem cell therapies and their targets, stem cell-related interventions. Statements about stem cell therapies relating to evidence of inefficacy, limited evidence of efficacy, general procedural risks, risks specific to the mode of therapy, regulatory status, experimental or unproven nature of therapy. Use of hype language (eg, language that exaggerates potential benefits).
Results 243 websites offered stem cell therapies. Many websites advertised stem cell transplantation from multiple sources, such as adipose-derived (112), bone marrow-derived (100), blood-derived (28), umbilical cord-derived (26) and others. Plant stem cell-based treatments and products (20) were also advertised. Purposes for and targets of treatment included pain, physical injury, a wide range of diseases and illnesses, cosmetic concerns, non-cosmetic ageing, sexual enhancement and others. Medical doctors (130), chiropractors (53) and naturopaths (44) commonly work in the clinics we found to be offering stem cell therapies. Few clinic websites advertising stem cell therapies included important additional information, including statements about evidence of inefficacy (present on only 12.76% of websites), statements about limited evidence of efficacy (18.93%), statements of general risks (24.69%), statements of risks specific to the mode(s) of therapy (5.76%), statements as to the regulatory status of the therapies (30.86%) and statements that the therapy is experimental or unproven (33.33%). Hype language was noted (31.69%).
Conclusions Stem cell therapies and related interventions are marketed for a wide breadth of conditions and are being offered by complementary and alternative practitioners, often in conjunction with medical doctors. Consumer protection and truth-in-advertising regulation could play important roles in addressing misleading marketing practices in this area.
- stem cells
- complementary medicine
- marketing
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Strengths and limitations of this study
The involvement of complementary and alternative medicine practitioners in the marketing of stem cell therapies and stem cell-related interventions is understudied, and this research helps us understand the extent to which they are involved, and also the extent to which they collaborate with medical professionals.
The methodology was designed in such a way that human error was minimised; manual searching of websites was largely replaced by automated domain searches by Google, which helped coders to achieve near perfect agreement in Cohen’s kappa reliability testing.
The search terms selected did not fully encompass the gamut of existing complementary and alternative medicine practitioner types, omitting some less common types such as reiki providers and reflexologists.
Because the coding frame was applied solely to the specific webpages on web domains where the term ‘stem cell’ was found by Google, and not to the entirety of existing content on a given domain, it is possible that broad disclaimers and other relevant information were excluded.
Introduction
Stem cell research has considerable clinical potential and scientific discoveries continue to advance our knowledge in this field.1 2 Yet, despite enthusiastic media coverage of the field,3 only a few stem cell-based therapies are currently ready for clinical application.4–6 This reality has not stopped the proliferation of clinics around the world advertising a wide array of unproven stem cell-based interventions.7–9 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,12 it is currently spreading to jurisdictions throughout the world.9 13 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.10 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,15 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.16
While there are services that seek to encourage websites to provide accurate health information,17 the continued proliferation of misleading marketing highlights the need for additional steps.16 Indeed, there may be a relationship between low-quality health information and the presence of marketing for products and services.17 18 A key skill for individuals is the ability to distinguish between trustworthy sources of health information and unreliable purveyors of misinformation. Misinformation is a concern for various reasons, particularly where it may be relied on by people making health-related decisions. Consumer protection and truth-in-advertising laws have been proposed as potentially useful avenues of response to health misinformation,19 as has greater use of professional discipline to govern the conduct of providers who are members of regulated health professions, with a particular focus on physicians.20
In order to evaluate the potential utility of these and other related strategies, it is important to understand, first, what kinds of healthcare providers (beyond physicians) are purportedly providing these unproven interventions, and second, how these services are being marketed to the public (ie, are the claims being made potentially inaccurate or misleading?). Identifying the professional status of those involved in the marketing of unproven stem cell-based interventions is necessary for ascertaining whether or not they are subject to professional regulation, and if so, what relevant rules govern their conduct in this field. At the same time, gathering data on the specific nature of the claims being made will highlight where existing consumer protection and truth-in-advertising laws may be triggered.
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. This raises potential safety concerns, particularly if the practitioner is not adequately trained in the relevant procedure. In addition, marketing of this kind raises the issue of ‘scienceploitation’.24 ‘Scienceploitation’ occurs when popular scientific ideas, such as stem cells, are used to take advantage of the social capital associated with them and induce consumer interest in products or services. It is a potentially harmful practice that can mislead the public and damage public trust in legitimate science. ‘Scienceploitation’ is related to but distinct from hype as the former goes beyond mere exaggeration and creates misunderstandings and/or posits false connections.
Improving understanding about CAM involvement in the private stem cell market will support identification and evaluation of available policy options in this field and will also contribute to broader considerations of issues associated with the marketing of CAM products and services in general. Accordingly, the goal of this research was to identify CAM providers advertising stem cell-related interventions via publicly accessible websites, and then to map the types of claims being made about those interventions. We first sought to identify relevant clinic websites using search terms focused on CAM practitioner types (eg, ‘naturopaths’) and common CAM terminology (eg, ‘holistic’), and then to analyse the information presented on those clinic websites about stem cells and stem cell-related therapies.
Methods
In order to establish a data set of web domains owned by relevant clinics offering stem cell-related interventions, multiple searches were undertaken in November 2016 on http://www.google.com/, with personalised results disabled. The search terms were naturopath stem cell, acupuncturist stem cell, homeopath stem cell, chiropractor stem cell, midwife stem cell, natural stem cell, alternative stem cell, holistic stem cell and complementary stem cell. For each search term, we attempted to identify 60 clinic websites in order of appearance; however, in some cases (eg, for the search ‘complementary stem cell’) the Google search results terminated before producing 60 clinic websites. Only web domains for clinics or practitioners with physical addresses were included as results. Supplement shops lacking a clinical component were excluded.
Once all the websites were collected, duplicates were identified and removed. Websites were shortened to their basic domain name (eg, http://www.stemcellclinic.com/about_us would be shortened to http://www.stemcellclinic.com/), and combined into a unified data set of 403 unique web domains. We chose in our methodology to sort the clinic web domains by coding categories, such as practitioner type, rather than by the search terms under which they appeared. This prevented miscategorisation in instances where a practitioner type appeared that was different from the search term. For example, naturopath clinic websites were found in the ‘acupuncturist stem cell’ search. Therefore, information connecting a web domain to the search term in which it occurred was discarded.
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.25 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.
During coding, it became clear that several of the domains had become non-functional, had redirected to a different unrelated domain, no longer contained any mention of stem cells or on closer analysis were not clinic websites (eg, blogs, online stores). These domains were excluded, leaving a final sample of 368 web domains to analyse.
Coding frame summary
In what country is the physical address listed on the clinic website located?
What practitioner types are listed as clinic staff on the web domain? Choose all that apply (see table 5 for coding categories).
What types of stem cell therapies or products, as defined by the claimed source of the stem cells and their mode of usage, are marketed? Choose all that apply (see table 4 for coding categories).
What categories of conditions are targeted by the therapies advertised? Choose all that apply (see table 3 for coding categories). Notes on coding categories:
The ‘other illness/disease’ category is defined as diseases or maladies including autoimmune disorders, degenerative conditions, genetic disorders, infectious diseases and environmental harms, other than chronic conditions primarily affecting on the bones, joints and muscles.
The ‘ageing’ category includes issues related to ageing that are not cosmetic or aesthetic. This clearly distinguishes it from the ‘cosmetic’ category.
What other treatments mentioning stem cells but not actually using them are marketed? Choose all that apply (see table 2 for coding categories).
Are there any statements relating to the stem cell therapy or therapies indicating there is evidence of inefficacy?
Are there any statements relating to the stem cell therapy or therapies indicating there is limited evidence of efficacy?
Are there any statements relating to the stem cell therapy or therapies indicating the general risks of the procedure? (eg, minor risk of infection from injection, minor risk of allergic response, side effects of pain or soreness)
Are there any statements relating to the stem cell therapy or therapies indicating the risks specific to the mode of therapy? (eg, worsening joint pain or joint malfunction caused by the injection of stem cells, unintended growth of different tissue)
Are there any statements relating to the stem cell therapy or therapies indicating regulatory status? (eg, U.S. Food and Drug Administration approved or not)
Are there any statements relating to the stem cell therapy or therapies indicating that the therapy is experimental or unproven?
Are there any statements relating to the stem cell therapy or therapies that use hype language? This is defined as exaggerated or extreme language when speaking about potential benefits, for example, breakthrough, revolution/revolutionary, cure, incredible, amazing and magical.
Results
Of the 368 web domains, 243 marketed stem cell therapies, and 116 marketed other interventions where stem cells were mentioned in the description of the treatment or its effects (eg, stem cells were ‘activated’ or ‘stimulated’), including platelet-rich plasma injections (88), prolotherapy (19) and others (9). Many websites advertised stem cell transplantation from multiple sources, such as adipose-derived (112), bone marrow-derived (100), blood-derived (28), umbilical cord-derived (26) and others. Plant stem cell-based treatments and products (eg, skin creams) (20) were also advertised. Tables 1 and 2 summarise the types of therapies offered and provide excerpts from selected websites as examples.
Modes of stem cell therapy offered (among web domains marketing stem cell therapies, n=243)
Other treatments offered that reference stem cells (among all web domains, n=368)
Treatment targets for stem cell treatments varied, but were most commonly pain/injury relating to the bones, joints and muscles (182), illness (diseases or maladies including autoimmune disorders, degenerative conditions, genetic disorders, infectious diseases and environmental harms, other than chronic conditions primarily affecting the bones, joints and muscles) (82), cosmetic concerns (52), non-cosmetic ageing (44) and sexual enhancement (18). Table 3 summarises treatment targets and provides excerpts showing examples of claims noted.
Advertised stem cell treatment targets (among web domains marketing stem cell therapies, n=243)
The majority of the clinics from the sample were located in the USA (see table 4). 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). Table 5 summarises the practitioner types noted in the results.
Clinic country of origin (as noted on web domain)
Practitioner types noted on web domains
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.
Claims and language used (among web domains marketing stem cell therapies, n=243)
Intercoder reliability testing was completed for 79 of the 368 entries, or 21.47% of the sample. Kappa scores were calculated based on intercoder agreement and are summarised in table 7. The scores reflect substantial to perfect agreement between coders.26
Cohen’s kappa scores for intercoder reliability (79/368 recoded=21.5%)
Selected examples of stem cell-related claims, sorted by practitioner type listed on the relevant web domain, are included in table 8.
Selected examples of stem cell-related claims made, by practitioner type listed on website
Discussion
This research was undertaken to determine the extent to which CAM practitioners are involved in online advertising of stem cell-related interventions, what kinds of claims are made and what relevant scientific, ethical and legal disclosures accompany these representations. The results show that CAM practitioners are now highly involved in advertising these interventions, often advertise medically serious procedures such as autologous bone marrow stem cell transplantation and largely fail to make reasonable and essential disclosures.
Indeed, it is concerning that the majority of the web domains advertising stem cell-related interventions did not include disclosures about scientific evidence of efficacy (or lack thereof), about general and/or specific risks associated with the intervention(s) offered, about the experimental nature of the treatments or about their regulatory status. This finding is consistent with past research on the marketing of stem cell therapies, which has indicated similar deficiencies and potentially problematic advertising practices.12 13 27 28 Failing to provide accurate and complete information may impact potential patients’ ability to give informed consent to treatment, and exaggerated claims, including potentially false, misleading or deceptive promotion, may risk running afoul of marketing regulations.
Adipose-derived autologous stem cell transplantation was the most common type of therapy advertised (table 1). This may reflect the fact that the procedure to remove fat tissue is generally less intensive and invasive than extracting bone marrow, though the latter was also popular. Together, these two forms of therapy comprised the dominant offerings observed. Yet, there can be safety issues with these therapies as noted by bodies like the International Society of Stem Cell Research, and many are not approved by national regulatory institutions.4 5
The health targets of stem cell therapies largely consisted of chronic conditions like musculoskeletal pain and deterioration, and this extended to the ‘other illness/disease’ category, where conditions like chronic obstructed pulmonary disorder and congestive heart failure were targeted. This distribution reflects a common demographic of individuals who may have unmet medical needs (eg, pain not satisfactorily remedied by conventional treatment), for whom conventional medicine can provide neither an effective solution nor satisfactory relief from daily symptoms.29 A strong secondary focus on arguably less medically serious conditions related to ageing, cosmetics and sexuality also reflects the creep of these multibillion dollar industries into the realm of stem cells.30
It is notable to see how many CAM practitioners are offering stem cell-related interventions or are in some other way using stem cells to market their products or services. Of course, it is important to distinguish interventions involving stem cell injections and those that merely reference stem cells for advertising effect (or in some cases, potentially for scientifically justified reasons). The former can present serious physical risks to patients receiving injections, and while the latter can also cause harm, they tend to be less invasive and lower risk. Stem cell science, research and clinical application are very specialised, and it is highly unlikely that the broad array of CAM practitioners noted in this study each have the requisite expertise to work with stem cells in a safe and effective manner.6 In some cases, and depending on the jurisdiction, these practitioners are either unregulated, regulated less stringently than medical doctors or have been granted self-regulation but have failed to either establish and/or enforce any clearly defined evidence-based standard of care.31 Professional regulation—including self-regulation—of CAM providers is growing,32 33 though there remains concern about a lack of appropriate oversight.12 Where a particular category of CAM practitioners is professionally regulated, employing professional oversight and discipline may be one option for controlling problematic practices. However, the ability and willingness of CAM regulators to set and enforce relevant standards in this context remains to be seen. At present it seems likely that other strategies—such as the use of consumer protection and truth-in-advertising laws—may be more readily available and broadly relevant.
Despite our focus on CAM in the methodology and the presence of many CAM practitioners marketing stem cell therapies in our results, we were surprised that medical doctors were still the most common practitioner type noted. These 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.8 16 34–36
In this research, we found that 116 web domains advertised non-stem cell interventions with language that references stem cells (see table 2 for examples), which was arguably done in order to leverage the excitement surrounding stem cell science in order to market products. The application of truth-in-advertising laws may be one way to ensure that claims made are not false or misleading in a material respect,37 and thus do not contribute to this kind of inappropriate ‘scienceploitation’.
Many countries around the world have laws and policies, supported by enforcement agencies, prohibiting demonstrably false or misleading marketing claims.18 For example, in the USA, the Federal Trade Commission regulates marketing claims using the Federal Trade Commission Act and prohibits ‘deceptive and unfair acts or practices’, that is to say, those that mislead consumers and affect their ‘behavior or decisions about the product or service’.38 39 Similarly, in Canada, the Competition Bureau enforces the Competition Act which requires that representations must not be false or misleading ‘in a material respect’, that is to say, in a manner that could ‘influence the ordinary consumer to buy or use the advertised product or service’.40 41 Although not without their challenges in terms of application and enforcement, these consumer protection and truth-in-advertising governance frameworks are certainly relevant to, and in some cases should be triggered by, the questionable claims found in this study, especially those regarding the safety, efficacy and the supposedly ‘revolutionary’ quality of some interventions advertised.
Limitations
While the study covered the majority of the most common types of CAM providers used in the USA (excepting massage therapists which were not specifically searched for given the context of stem cells, but were nonetheless noted),42 the search terms selected did not fully encompass the gamut of existing CAM practitioner types, omitting many less common types, including reiki providers and reflexologists. Moreover, given the fact that the search was undertaken in the English language on the American version of the Google search engine, there may have been an overrepresentation of American and/or English-speaking clinics. As mentioned in the methods, the coding frame was applied only to the specific webpages on web domains where the term ‘stem cell’ was found by Google, and not to the entirety of existing content on a given domain. It is possible that broad disclaimers and other relevant information were therefore excluded. Finally, our research focus was on exploring how, and by whom, stem cells are used to market health services and interventions. Though we did not evaluate claims against peer-reviewed scientific literature and thus cannot make any definitive statements as to the accuracy of any of the marketing claims, in future research this important task could be undertaken.
Conclusion
Our research indicates that clinics using stem cell language to advertise their services do so in many different forms, for many different conditions, and often without disclosing evidence, risks or regulatory information. Many CAM practitioners are now actively involved in offering and advertising stem cell-based interventions, often alongside physicians. Professional regulation may provide one avenue of oversight and enforcement for problematic conduct, but its application will be limited to regulated health professionals and impacted considerably by the strength (and will) of the regulatory regime. The questionable nature of many of the claims we found, along with the absence of important qualifying information, suggests consumer protection and truth-in-advertising regulations are highly relevant to this market and indeed could prove very useful in constraining some of the more egregious marketing practices identified. The applicability of these regulatory regimes do not depend on the professional status of those advertising the services and rather typically focus on the general impression the representation conveys to the public.43
The use of consumer protection and truth-in-advertising regulation to curtail misleading advertising in the private, direct-to-consumer market for stem cell interventions is an area well worth further research and consideration. Important questions will include how existing legal and policy tools could be used to regulate the claims made by clinics advertising stem cell-related interventions and how to effectively enforce the law among clinics or individual practitioners that engage in misleading marketing practices, particularly given the cross-border nature of this market. A related issue that also bears monitoring is how the practices of clinics offering unproven stem cell interventions relate to concerns about ‘scienceploitation’ and its potential harms. Many clinics seem to be engaging in scienceploitation, which can seriously obfuscate public discourse, mislead the public and make it difficult to discern real science from marketing claims that merely reference scientific sounding terminology. The marketing of unproven stem cell therapies has the potential to harm patients and to harm the reputation of stem cell science. It is incumbent on regulators and policymakers to take a proactive approach to managing the risks associated with the growing private market for stem cell-related interventions, and addressing misleading marketing practices is an important part of this strategy.
Acknowledgments
The authors thank Robyn Hyde-Lay for her advice and guidance, and for her aid in developing applications to secure funding for this project. The authors would also like to thank research assistants Daniel Downie, Yassine El Balhouli and Corinna Liu for their help with data collection.
References
Footnotes
Contributors All authors designed the study, analysed the data and wrote the article.
Funding This work was supported by the Stem Cell Network, grant number FY17/PP1 RES0032389, and the Trudeau Foundation, grant number RES0019335.
Competing interests None declared.
Patient consent Not applicable.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Original data set and time-stamped screenshots of all example statements found in the tables are available upon request to the corresponding author.