Using online platforms such as GoFundMe to solicit donations for health-related needs can help people access legitimate health services and avoid medical debt. But this kind of medical crowdfunding also raises funds for a multitude of scientifically unsupported procedures. We are particularly concerned about crowdfunding campaigns for unproven and unlicensed stem cell interventions, for which there is little or no evidence of safety and effectiveness.
Campaigns that seek donations for unproven stem cell interventions waste donors’ money, spread misinformation, and obscure the significant risks that unproven stem cell procedures can pose to patient safety.
Here’s a typical example from GoFundMe, which lists thousands of campaigns for stem cell therapy. In it, the campaigner describes his wife’s degenerating health as a result of Parkinson’s disease. He describes his search for an “alternative procedure” to help reverse it and the promise of adult stem cell treatment. As a result of this treatment, he writes, they “truly believe that Sharon will experience a far happier life, unhindered by daily struggles such as simply being able to walk or drive.”
The cost for this particular stem cell treatment is listed as $16,900, with other related costs bringing the total sought to $22,300. Evidence for this therapy is given in the form of links back to the website of the company selling this stem cell intervention, thus serving as an advertisement for its services.
The problem is that there isn’t solid evidence that stem cell procedures reverse Parkinson’s disease or even halt its progression.
Such campaigns exploit sympathetic donors by persuading a large number of individuals to give small amounts of money that add up to millions of dollars in support of interventions that are not backed by credible scientific evidence.
As our research shows, many of these campaigns are linked to two companies: StemGenex, based in San Diego, and the Lung Institute, which has offices in Arizona, Texas, Tennessee, Florida, and Pennsylvania. Both companies direct potential clients toward crowdfunding. The Lung Institute, for example, encourages potential clients who “don’t have the cash” for their services to use GoFundMe, calling crowdfunding “simple and effective.” Neither StemGenex nor the Lung Institute are on the FDA’s list of companies with approved cellular therapies. The two companies are currently being sued by former patients who allege they were duped by inaccurate marketing claims.
While there is nothing new about companies marketing dubious stem cell treatments and taking advantage of vulnerable, hopeful, and sometimes desperate individuals, crowdfunding sites are a boon for businesses selling them. Many such companies actively encourage prospective clients to create crowdfunding campaigns and obtain access to funds they would not otherwise possess. In this way, clinics selling unlicensed and unproven stem cell interventions manage to capture funding not only from individual patients but also from social networks of sympathetic donors.
Crowdfunding campaigns also play a key role in propagating and amplifying the misinformation spread by clinics that advertise unproven stem cell therapies. Crowdfunding campaigners often parrot the marketing messages of these clinics by depicting stem cell treatments as safe and effective, spreading such unfounded claims to donors and others exposed to these campaigns online. In one typical campaign, the author describes these procedures as “simple and quick, and with only minimal side effects.” Another campaign repeats claims of “a 92 percent success rate.”
Such misinformation is particularly worrisome because it is often spread by personal connections through social networks, making it more likely to be taken at face value.
To convince potential donors that stem cell interventions are scientifically legitimate and represent a worthwhile investment, many people who seek crowdfunding for stem cell therapies make misleading claims about how their particular treatment will contribute to scientific research.
Some crowdfunding campaigns, for example, inaccurately claim that being treated with an unproven stem cell intervention will contribute to its eventual FDA approval. Other campaigns refer to studies registered with Clinicaltrials.gov. The National Institutes of Health created this database and website as a repository for scientifically legitimate clinical trials, but it does not carefully screen studies before they are entered into the publicly accessible database. As a result, ClinicalTrials.gov now includes “pay-to-participate” trials that appear to be little more than marketing tools used by clinics selling unproven stem cell interventions.
The NIH is aware of concerns about the integrity of the database, and has said it intends to be responsive to criticism that ClinicalTrials.gov is being used as a marketing platform by clinics selling unproven stem cell interventions. To date, though, it has not taken meaningful steps to address clinics misrepresenting that the NIH is overseeing or reviewing their stem cell procedures.
Inaccurate claims clinics make about NIH and FDA oversight, review, or approval proliferate across crowdfunding sites, making these interventions appear legitimate and trustworthy.
Regulators can take several practical steps to address such misrepresentations. While the NIH posts disclaimers on Clinicaltrials.gov (“Listing a study does not mean it has been evaluated by the U.S. Federal Government”), it should stop the practice of listing studies without adequate screening. Until the NIH develops effective tools that ensure submitted trials meet basic ethical, scientific, and legal standards, registration on the site provides an opportunity for companies touting unproven stem cell procedures to associate themselves with reputable federal agencies, mixing their “brands” together in ways that confuse the public.
Another step the NIH should take is to remove from ClinicalTrials.gov “studies” registered by companies selling unproven and unlicensed stem cell procedures and replace them with retraction notices.
The NIH should also make it easier for concerned individuals to identify problematic studies and bring their concerns to the attention of NIH officials.
Finally, the FDA must step up its enforcement actions against clinics selling unproven and unlicensed stem cell procedures. In May of this year, the FDA sought permanent injunctions against two such businesses — Florida-based US Stem Cell and California Stem Cell Treatment Center — for marketing unapproved stem cell procedures. While the FDA is to be commended for taking action against these companies, hundreds of other clinics continue to sell stem cell procedures without FDA approval. To date, there is no record of the FDA taking regulatory action against these other clinics, even though they, too, are selling unlicensed stem cell procedures.
We believe that the phenomenon of crowdfunding is an important factor to consider as the NIH, FDA, and other regulatory bodies develop enforcement priorities for unproven stem cell procedures. While some of the public’s interest in crowdfunding for these services is an organic product of popular interest in stem cell treatments and the visibility and utility of crowdfunding, much of it is the result of a push by specific companies for their customers to crowdfund their services.
By encouraging crowdfunding, such businesses move from exploiting their immediate clientele to extracting revenue from entire social networks. Similarly, they advance from spreading misinformation via their websites, social media, and other marketing tools to deploying their clients and prospective clients as viral marketers of misinformation.
The FDA and NIH should send a strong message that they will not allow crowdfunding campaigns pushed by companies selling unproven and unlicensed stem cell interventions to serve as financial schemes for misleading and exploiting the public.
Jeremy Snyder, Ph.D., is an associate professor in the Faculty of Health Sciences at Simon Fraser University in British Columbia, Canada. Leigh Turner, Ph.D., is an associate professor in the Center for Bioethics, School of Public Health, and College of Pharmacy at the University of Minnesota. On a pro bono basis, he submitted an expert opinion report supporting claims of plaintiffs in litigation filed against the Lung Institute’s Florida clinic. Valorie A. Crooks, Ph.D., is a professor of geography at Simon Fraser University and holds the Canada Research Chair in Health Service Geographies.
Excellent article about these scam artists. Very good recomendation for cleaning up clinicaltrials.gov. It must stop being used to promote these phony treatments.
Agree with Frank. And, to boot, two of the op ed piece authors aren’t even in the US…they’re in Canada. I think my boyfriend would have died had he not been treated in Los Algodones Mexico who was $3k for the treatment, not in the range described in the article.
Seeing that three wrote this opinion that stated their points, then hammered readers by restating. I bristled throughout. The heavy handed “sound the alarm” on every point joined with hurried emergency, are key qualities of a scam.
It’s terrible that you want to control people going about THEIR business. You don’t approve of the way people choose to spend their money, as individuals and group. You want to control mass public communications.
At the NIH study data base, you insult us thinking we are unaware of the meaning and weight of a disclaimer. I got it you don’t like what people choose to read and you believe they are incapable of discerning what is robust and not. You want to catagorically restrict information.
On social media, you want such topic conversations stopped. Desire to force people to grab only on information you value. And just how valuable is it that it can not be among differing inquiry or new directions?
Have you forgotten communication is a two way street. Bad information has as much chance as good information with a sum gain of being self correcting.
How dare you seek to control the public on personal health matters by these ways. Double dare you want to use our collective governmental treasure to do so. People have a right to make bad decisions. A smart one learns from self made mistakes. A wise one learns from mistakes of others.
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