Abstract
Objective To characterize the marketplace for direct-to-consumer (DTC) unproven stem cell-based interventions (SCBI) for neurologic diseases and injuries using crowdfunding data.
Methods Search terms were developed from previous empirical studies of DTC businesses and the International Classification of Diseases–11 for neurologic diseases and used to query GoFundMe's internal search engine. Campaigns initiated November 2017–2018 and seeking SCBI for neurologic diseases and injuries (n = 1,030) were reviewed to identify the number of donors, number of Facebook shares, recipient location, funding pledged, funding requested, underlying neurologic condition, treatment location, and treatment facility name.
Results A total of 1,030 crowdfunding campaigns for SCBI for neurologic diseases and injuries requested $33,449,979 and received $5,057,069 from 38,713 donors. The most common neurologic condition identified was multiple sclerosis (MS) (n = 404, 35.5%). Of campaigns naming specific destination facilities (n = 392), the most common clinical settings identified were the Stem Cell Institute in Panama City, Panama (n = 91, 23.2%), StemGenex in San Diego, California (n = 44, 11.2%), and Clinica Ruiz in Puebla, Mexico (n = 36, 9.2%).
Conclusions MS dominated the total number of crowdfunding campaigns. Most campaigns were linked to individuals from regions geographically proximal to destination facilities advertising SCBI for particular neurologic diseases. Most of the clinical destinations were located in comparatively high-income countries such as the United States, Mexico, and Panama. These findings provide considerable insight into the DTC marketplace for SCBI. Analysis of crowdfunding campaigns can be used to develop more targeted patient education initiatives and health policies related to domestic and international travel for unproven SCBI.
Glossary
- ASD=
- autism spectrum disorder;
- DTC=
- direct-to-consumer;
- MS=
- multiple sclerosis;
- SCBI=
- stem cell-based interventions
Over the last decade, businesses engaged in direct-to-consumer (DTC) advertising of unproven stem cell-based interventions (SCBI) have proliferated globally. Clinics selling putative stem cell treatments first emerged in China, India, Mexico, and other countries with relatively weak governance frameworks for cellular therapies.1,2 Such clinics later appeared in Australia, Canada, Japan, the United States, and other nations once thought to have robust oversight of stem cell-based drugs, biologics, and medical devices.3,–,5 These clinics market purported “stem cell treatments” for clinical indications ranging from orthopedic diseases, sports injuries, pain relief, and cosmetic applications to neurologic, immunologic, cardiovascular, and respiratory diseases.1,4
Studies examining promotional claims made by businesses selling SCBI on a DTC basis have found that most such clinics fail to disclose procedure-related risks adequately; make exaggerated and unwarranted claims concerning therapeutic benefits; engage in aggressive “hard sell” sales tactics that exploit the vulnerabilities of ill individuals; rely upon testimonials and celebrity endorsements rather than meaningful forms of scientific evidence; and use assorted “tokens of scientific legitimacy” to persuade prospective clients that they can obtain access to credible stem cell treatments.1,6,–,10 Such commercial activity generates a host of ethical and legal concerns.11,12 Researchers have paid particular attention to manipulative use of “stem cell hype” and sometimes outright misrepresentation functioning as compelling but inaccurate marketing techniques.13,14 Several legal actions allege that clinics selling unproven SCBI used fraudulent advertising claims to prey upon their clients.15,16 Moreover, reports of fatalities and serious injuries reveal that some unproven SCBI pose substantial risks to patients.17
Despite considerable scholarship and news media reports raising serious concerns related to the safety and efficacy of unproven SCBI, many patients and their loved ones are nonetheless interested in accessing what are promoted to them as risk-free and effective therapies. Given the substantial cost of SCBI, accessing these interventions can be challenging. As a result, many individuals engage in online crowdfunding to generate the financial resources needed to undergo such procedures.18,19
Despite the rapid popularization of crowdfunding for health-related purposes, little is known about the relationship between crowdfunding campaigns and specific businesses selling purported stem cell treatments, the geographic location of patients engaged in crowdfunding activity intended to provide financial support for accessing SCBI, and the medical conditions most commonly identified in crowdfunding campaigns of individuals planning to undergo SCBI. In particular, crowdfunding campaigns of individuals seeking SCBI for neurologic diseases and injuries have attracted little critical scrutiny, even though a substantial body of research documents that SCBI for neurologic diseases are an important part of the DTC marketplace and there are documented reports of patients with neurologic diseases having serious complications or loss of personal savings as a result of undergoing unproven SCBI.20,21 To address this gap in scholarship and provide insights into the DTC SCBI marketplace for neurologic conditions more generally, we examined crowdfunding campaigns for purported stem cell treatments of neurologic diseases.
Methods
To create a list of neurologic diseases and injuries for which patients might crowdfund for SCBI, we first reviewed peer-reviewed empirical studies of businesses engaged in DTC marketing of SCBI.4,5,22,23 We augmented this list with neurologic diseases from the WHO's International Classification of Diseases,24 removed duplicate diseases, and combined overlapping terms into simplified disease categories. This process generated 276 distinct search terms.
We then used GoFundMe's internal search engine to identify crowdfunding campaigns created for persons seeking SCBI for neurologic diseases. We selected GoFundMe because of its prominence as a crowdfunding platform and because of the many health-related crowdfunding campaigns it hosts. This search was conducted by identifying GoFundMe crowdfunding campaigns mentioning any of the 276 neurologic disease search terms and “stem cell.” This process resulted in the initial identification of 8,971 campaigns. After duplicate campaigns were removed, 4,428 unique campaigns remained.
To refine our review, we sorted these campaigns chronologically and then reviewed all campaigns initiated in the most recent year since the search was conducted (November 2018), resulting in 1,649 campaigns. After excluding all campaigns not seeking funding for SCBI for neurologic diseases, we were left with 1,030 campaigns. In a small number of cases, these included campaigns to pay to participate in a clinical trial or to receive SCBI outside of clinical trials on an expanded access (or “compassionate access”) basis. We chose to include these campaigns in this analysis as, along with DTC businesses, these clinical studies have prompted individuals to engage in crowdfunding activity with the objective of obtaining access to unlicensed and unproven SCBIs for neurologic conditions.
These campaigns were then individually reviewed to identify the campaign title, number of donors, number of shares on Facebook, campaign location, funding pledged, funding requested, campaign creation date, neurologic disease motivating the campaign, location of desired treatment, name of facility offering the treatment, and type of SCBI sought. When funding amounts were not listed in US dollars, these sums were converted to US dollars at the currency exchange rate for the date the campaign was initiated. In some cases, the campaign location differed from the location of the person meant to receive these funds (e.g., due to GoFundMe not operating in that country); in these cases, the campaign location information was amended accordingly. Each author recorded this information for half of these campaigns and audited 5% of the other author's data entry to ensure reliability and consistency in data entry.
Data availability
Data for this study are available at drive.google.com/open?id=1msHQLNZz_GPtXnh1keKfwdRcHQbQeSnT&usp=sharing.
Results
In total, the 1,030 crowdfunding campaigns for SCBI intended to treat neurologic diseases and injuries requested $33,449,979 (average $32,476) and received $5,057,069 (average $4,910) or 15.1% of the funding requested. This money was pledged from 38,713 donors (average 37.59). The campaigns were shared via Facebook 199,490 times (average 193.68).
These campaigns raised funds for 1,137 instances of neurologic diseases or injuries, a total greater than the number of campaigns reviewed as some campaigns sought funds for SCBI intended to treat 2 or more neurologic conditions. The most common neurologic condition identified in these campaigns was multiple sclerosis (MS) (n = 404, 35.5%). Other neurologic conditions accounting for 5% or more of named conditions were autism spectrum disorder (ASD) (n = 108, 9.5%), spinal cord injury, paralysis, or paraplegia (n = 101, 8.9%), cerebral palsy (n = 81, 7.1%), and stroke (n = 57, 5.0%) (table 1).
Neurologic condition categories (minimum 1% of total)
Campaign recipients were situated largely in a few predominantly English-speaking countries. A total of 803 (78.1%) of the 1,029 campaigns that identified recipient locations were for US recipients. The United Kingdom contributed 74 (7.2%) recipients, Canada 55 (5.3%), Australia 32 (3.1%), and Ireland 7 (0.7%). No other single country contributed more than 4 campaigns. A small number of campaigns were set in other regions of the world: Europe had 27 campaigns, Africa 14, the Middle East and Asia 8, South America 5, and Central America, Mexico, and the Caribbean totaled 4.
Of campaigns naming specific destination facilities (n = 392), the most common clinical settings identified were the Stem Cell Institute in Panama City, Panama (n = 91, 23.2%), StemGenex in San Diego, California (n = 44, 11.2%), Clinica Ruiz in Puebla, Mexico (n = 36, 9.2%), Northwestern University Hospital in Chicago, Illinois (n = 19, 4.9%), Duke University/Children's Hospital in Durham, North Carolina (n = 15, 3.8%), AA Maximov Hospital in Moscow, Russia (n = 10, 3.9%), NeuroGen Brain and Spine Institute in Mumbai, India (n = 9, 2.3%), GIOSTAR USA in Mexico and California (n = 8, 2.0%), and MD Stem Cells in Florida and Connecticut (n = 8, 2.0%) (table 2).
Destination names (minimum 2% of total named)
Destination facility locations were named in 627 campaigns. The largest single destination country was the United States (n = 276, 44.0%), with California (n = 98), Illinois (n = 38), Florida (n = 33), Arizona (n = 17), and North Carolina (n = 17) the most common state destinations. Panama was the second most common destination country (n = 128, 20.4%), followed by Mexico (n = 87, 13.9%), Russia (n = 41, 6.5%), India (n = 22, 3.5%), Thailand (n = 19, 3.0%), and China (n = 12, 1.9%). Europe, excluding Russia, included 16 campaigns, followed by Central America and the Caribbean (excluding Panama) (n = 5), and South America (n = 4). Canada (n = 6), South Korea (n = 4), Turkey (n = 4), Australia (n = 2), and Israel (n = 1) made up the facility locations for the remaining campaigns. A map of these locations is available at drive.google.com/open?id=1msHQLNZz_GPtXnh1keKfwdRcHQbQeSnT&usp=sharing.
The clients of particular destination facilities often had distinct profiles connected to geography and specific neurologic conditions. The Stem Cell Institute was the most diverse facility in these terms, attracting prospective patients largely from the United States, United Kingdom, Canada, Australia, and Europe, and treating them for ASD (n = 32), MS (n = 25), spinal cord injuries and paralysis (n = 12), and cerebral palsy (n = 4), among other conditions. An additional 37 campaigns naming Panama as a destination country but not naming the facility fit this profile and raised $126,166 more. By comparison, StemGenex focused largely on MS (n = 40) and drew clients entirely from the United States and Canada. Five additional campaigns naming San Diego as a destination fit this profile, raising $9,365. Clinica Ruiz similarly focused almost exclusively on MS (n = 35), with clients from the United States, United Kingdom, Canada, and Australia. Twenty additional campaigns fit this profile, raising $161,677. The clinical trials at Northwestern University focused on MS and chronic inflammatory demyelinating polyneuropathy and drew exclusively from the United States whereas the trials at Duke University included hypoxic ischemic encephalopathy, ASD, cerebral palsy, and hydrocephalus and drew from the United States and Canada. Eight additional campaigns raising $24,869 fit the profile of the former facility and 1 raising $7,030 fit the latter. Other facilities drew more from outside North America. For example, AA Maximov Hospital treated only MS and for clients from the United Kingdom, Europe, and Africa in addition to North America. Twenty-seven additional campaigns fit this profile, raising $399,832. The NeuroGen Brain and Spine Institute treated ASD, cerebral palsy, muscular dystrophy, and stroke and drew clients entirely from countries in Africa. Five additional campaigns raising $1,332 fit this profile. A map of recipients organized by destination and neurologic disease or injury is available at drive.google.com/open?id=1msHQLNZz_GPtXnh1keKfwdRcHQbQeSnT&usp=sharing.
Discussion
Our findings document that SCBI for which there is little evidence of efficacy and SCBI for which there is some evidence of safety and efficacy are attracting substantial public interest and prompting crowdfunding efforts. Most crowdfunding campaigns for SCBI intended to treat neurologic diseases and injuries involve individuals planning to visit DTC businesses; however, some campaigns are seeking donations for individuals hoping to either participate in clinical trials at academic medical centers or to obtain access to SCBI in these settings on an expanded access basis. In this latter type of crowdfunding campaigns, donations are sought to cover the cost of travel, accommodations, meals, and medical interventions not covered by clinical study sponsors or insurers. While we do not regard these academic health center–based clinical trial sites as businesses advertising unproven SCBI on a DTC basis, they fall within the scope of this study in part because patients often encounter substantial fees and expenses when they travel to academic medical centers for experimental SCBI.
Of the neurologic diseases and injuries for which we found individuals engaged in crowdfunding, MS dominated in terms of total number of crowdfunding campaigns, the amount requested by those campaigns, and the donations these campaigns generated. This finding is notable in part because the prevalence of MS in the United States (400,000–600,000) is lower than other neurologic diseases for which individuals sought SCBI, including Alzheimer disease and other dementias (7.5 million), stroke (6.8 million), epilepsy (2.8 million), traumatic brain injury (1.4–1.7 million), and Parkinson disease (630,000–1 million).25 These findings might be connected to the growing number of peer-reviewed publications providing evidence of the safety and efficacy of HSCT for particularly aggressive forms of MS.26,27 Such studies, widely covered in popular news media reports, have likely fostered hope that individuals with MS can benefit from SCBI and helped convince prospective donors to contribute to campaigns for SCBI for MS.
One problematic feature of crowdfunding campaigns for SCBI is that often they echo and amplify unsubstantiated claims made by businesses selling such stem cell products on a DTC basis. Moreover, they often utilize language associated with scientific legitimacy, including references to clinical trials and research activities; such language can divert resources from legitimate clinical research and potentially undermine trust in legitimate research.28 Such crowdfunding campaigns also pose a risk of wasting personal savings. In total, the crowdfunding campaigns in our dataset generated $5,057,069 in donations. While some campaigns sought donations for individuals to access SCBI at academic medical centers with longstanding records of contributing to peer-reviewed scientific research, in most instances these donations went to businesses that to date have not made significant contributions to clinical research evaluating safety and efficacy of SCBI for neurologic diseases.
Of the specific clinical destinations we identified, most were linked to crowdfunding campaigns for individuals from geographically proximal regions and treatment of particular neurologic diseases. One business, the Stem Cell Institute, was an exception from this general pattern, both in terms of the geographic spread of individuals engaging in crowdfunding to undergo SCBI at this facility and in terms of the number of different neurologic diseases for which persons engaged in crowdfunding sought treatment. Why businesses draw patients from particular locales and with specific conditions warrants further analysis.
Most of the clinical destinations identified by name in crowdfunding campaigns were located in comparatively high-income countries such as the United States, Mexico, and Panama. However, there was one notable exception to this general trend. NeuroGen Brain and Spine Institute, based in Mumbai, India, was referenced in 9 crowdfunding campaigns.
We found considerable variation in the extent to which crowdfunding campaigns for particular neurologic diseases prompted donations. Campaigns for individuals diagnosed with ALS, MS, spinal cord injury, and cerebral palsy had comparatively high average donation rates. In contrast, campaigns related to stroke, neuropathy, and ataxia had relatively low average donation rates. Why crowdfunding campaigns for particular neurologic diseases are successful at attracting donations while campaigns for other neurologic diseases receive few donations merits scrutiny in future studies of crowdfunding for health-related indications.
While our data are confined to individuals using crowdfunding campaigns to pay for their treatments, health insurers typically do not provide coverage of SCBI for neurologic diseases and injuries because there is insufficient evidence of safety and efficacy for funding such interventions. The widespread lack of health insurance coverage for SCBI intended to treat neurologic diseases means that individuals engaged in crowdfunding activities likely resemble at least to some extent the broader population of patients pursuing these interventions.
Limitations
While these data only capture those individuals using crowdfunding to pay for their treatments, health insurers typically do not provide coverage of SCBI for neurologic diseases and injuries because there is insufficient evidence of safety and efficacy for funding such interventions. Nonetheless, the study has several limitations worth noting. First, it examines crowdfunding campaigns on a particular crowdfunding platform but does not contain data from other crowdfunding websites used to seek donations for medical care. Second, English-language search terms were used to identify crowdfunding campaigns. Searches conducted in other languages, whether on GoFundMe or other crowdfunding websites, would presumably generate different findings. Third, while we attempted to establish and use a comprehensive list of search terms for the identification of neurologic diseases, it is possible that there are additional neurologic diseases for which crowdfunding campaigns have been established on GoFundMe for the purpose of soliciting donations for SCBI. Fourth, our data likely underestimate the overall size and effect of GoFundMe campaigns seeking donations for SCBI intended to treat individuals with neurologic diseases. For example, some of the campaigns we identified had just started at the time they were analyzed and may attract additional donations, be more widely shared on social media, and otherwise have greater effect than our research identified. Other campaigns initiated during our review period would have concluded and closed prior to data collection. Finally, campaigns were analyzed on the basis of online representations made about neurologic diseases and SCBI. Such an approach does not permit independent verification of diagnoses and other claims made in crowdfunding campaigns.
Many individuals with neurologic diseases or injuries use online crowdfunding campaigns to seek donations intended to cover expenses associated with undergoing SCBI. While there is growing evidence that hematopoietic stem cell transplants might in time become standard of care for some patients diagnosed with MS, the majority of these uses of SCBI are unproven, have not been approved by the Food and Drug Administration, and do not fall within the current standard of medical care. Marketing claims used to promote such SCBI often minimize risks, exaggerate the likelihood of benefits, and make it difficult for patients to make informed and evidence-based decisions. Clinicians providing care to patients considering undergoing unproven SCBI for neurologic diseases can play an important role in helping such individuals better understand safety and efficacy concerns related to unproven SCBI. In particular, physicians and other health care providers can help patients become aware of the possibility of serious complications and significant financial expenditures with little or no prospect of therapeutic benefits.
Whether crowdfunding campaigns seeking donations for unproven SCBI intended for treatment of neurologic conditions comply with the terms of service of GoFundMe and other leading crowdfunding platforms is a matter of debate. GoFundMe's Terms of Service stipulate that the site is not to be used for crowdfunding campaigns related to the use of unlicensed drugs.29 With many SCBI classified by the Food and Drug Administration and other national regulatory bodies as unlicensed drugs or biologics, it is fair to ask whether such campaigns violate the terms of service of the crowdfunding sites that host them. Despite this possible violation, to date GoFundMe and other crowdfunding platforms continue to permit such campaigns.
The existence of these campaigns provides considerable insight into the DTC marketplace for SCBI. Systematic analysis of such campaigns provides useful information concerning the countries and specific facilities to which individuals are traveling for SCBI, the countries from which patients are traveling, the sums of money they are attempting to raise, the donations they have successfully solicited, the neurologic diseases or injuries for which they are seeking treatment, the number of individuals who have made donations, and the extent to which such campaigns are shared on social media. To date, empirical study of DTC marketing of unproven SCBI has often focused on the marketing claims of businesses selling SCBI. Our research reveals that analysis of campaigns on crowdfunding platforms can be used to study representations made by prospective clients of such businesses. Such research can be used to develop more targeted patient education initiatives. It can also be used in the development of health policies related to domestic and international travel for unproven SCBI. While our research focuses on crowdfunding campaigns of individuals seeking SCBI for neurologic conditions, this approach can also be applied to other disease categories as well as to other kinds of unproven medical interventions.
Author contributions
Jeremy Snyder: drafting/revising the manuscript, data acquisition, study concept or design, analysis or interpretation of data, accepts responsibility for conduct of research and final approval, acquisition of data. Leigh Turner: drafting/revising the manuscript, data acquisition, analysis or interpretation of data, accepts responsibility for conduct of research and final approval.
Study funding
Study funded by the Greenwall Foundation.
Disclosure
The authors report no disclosures relevant to the manuscript. Go to Neurology.org/N for full disclosures.
Footnotes
Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
- Received February 26, 2019.
- Accepted in final form May 14, 2019.
- © 2019 American Academy of Neurology
References
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