Crowdfunding campaigns for unproven stem cell treatments exaggerate the benefits and underemphasize the risks, all the while raising considerable funds and generating social media buzz. According to a study published in JAMA this week, researchers discovered 408 funding campaigns, conducted via GoFundMe and YouCaring, seeking over $7 million in donations for stem cell treatments. And they succeeded: Over 13,000 donors gave almost $1.5 million and the campaigns had been shared more than 100,000 times on social media.
The researchers used a database of 315 direct-to-consumer stem cell businesses operating 570 clinics in the U.S. compiled a couple of years ago and published by Leigh Turner, Ph.D., a bioethicist, and Paul Knoepfler, Ph.D., a biologist, stem cell expert and guest poster on SBM, who said at the time:
Direct-to-consumer marketing of unapproved stem cell interventions is a well-known phenomenon in countries with lax medical regulations. However, an examination of Internet-based marketing claims revealed widespread promotion of such interventions by businesses based in the United States. Such commercial activity suggests that regulatory agencies must better oversee this marketplace.
David Gorski blogged about the study in detail on SBM and it received widespread media attention. Media outlets have also published several exposés, one of which was covered by Steve Novella just last week.
Unfortunately, the public remains gullible to stem cell pitchmen, who are aided by weak regulation of the industry, the FDA’s promise to “spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy” notwithstanding. The stem cell industry has been booming while FDA enforcement action remains anemic. As Drs. Turner and Knoepfler found in another study published earlier this year:
Between 2009 and 2014, the number of new US stem cell businesses with websites grew rapidly, at least doubling on average every year. From 2014 to 2016, approximately 90–100 new stem cell business websites appeared per year. In contrast, from 2012 to the present, regulatory activity in the form of FDA warning letters has been limited. These data point to a problematic disconnect between a rapidly expanding US direct-to-consumer stem cell industry and limited FDA oversight of this marketplace. More consistent, timely and effective FDA actions are urgently needed.
For the crowdfunding study, Dr. Turner and Jeremy Snyder, Ph.D., also a bioethicist, used the list of stem cell businesses generated in the 2016 study to search (from August to December, 2017) for mentions of each of these businesses on GoFundMe and YouCaring. In addition to extracting data on the amount of funding requested and pledged, number of donors, and shares on Facebook and Twitter, they looked at statements about the perceived risks and benefits of stem cell interventions. Of the 408 campaigns,
- 178 (43.6%) made statements that were definitive or certain about the intervention’s efficacy;
- 124 (30.4%) made statements optimistic or hopeful about efficacy;
- 63 (15.4%) made statements of both kinds;
- 43 (10.5%) did not make efficacy claims.
As well,
All mentions of risks (n=36) claimed the intervention had low/no risks compared with alternative treatments.
Dr. Snyder told The Washington Post that he was “surprised by the scope of it.”
There’s no blame for the individuals. They’re kind of trapped. . . They want to believe a lot of the times that this is going to really cure me. It’s absolutely a heartbreaking situation.
The researchers concluded that the unproven claims of crowdfunders simply reflect the unproven claims of DTC stem cell marketers:
The situation parallels that of DTC marketing of unproven stem cell-based interventions, which has been shown to make hyperbolic claims about efficacy and minimize risks associated with their use. . . These findings suggest that individuals interested in purchasing unproven stem cell interventions may reflect DTC marketing messages in crowdfunding campaigns, thus potentially helping propagate them.
And, in a statement that certainly will ring true for regular SBM readers,
These claims may be especially powerful when embedded within compelling personal narratives.
Unfortunately, the compelling personal narrative is both a favorite marketing come-on for purveyors of pseudoscience (like Stanislaw Burzynski) and an effective fundraising technique, no matter how innocently pitched. In fact, both GoFundMe and YouCaring advise crowdfunders that the compelling personal story is essential to successful fundraising.
Compelling personal stories
The FDA, which takes the position that it has the authority to regulate all stem cell products in the U.S., has approved products consisting of blood-forming stem cells derived from cord blood, which is approved only for limited use in patients with disorders affecting the body system involved in the production of blood (the hematopoietic system). (There are narrow approval exceptions for minimally manipulated stem cells for homologous use.) A number of clinical trials involving other types of stem cells to treat other diseases and conditions are ongoing. As the FDA warns, any legitimate clinical trial should be able to give you the FDA-issued Investigational New Drug (IND) Application number and a chance to review the FDA communication acknowledging the IND. The agency recommends asking for this information before getting treatment even if the stem cells are yours.
My search for “stem cell” on GoFundMe yielded over 8,000 hits. Not all were pleas for funding stem cell treatments (some just mentioned stem cells) and some asked for help with incidental expenses incurred in participating in legitimate clinical trials. Nevertheless, it wasn’t hard to find examples of unproven claims and uses unapproved by the FDA. Note that some of these do not mention a specific stem cell business and likely would not have been uncovered in the crowdfunding study, a limitation the researchers themselves noted as an indication that their study underestimated the total number of crowdfunding campaigns.
Dr. Snyder is right. These are truly heartbreaking, both in the suffering of the patients and their families as well as their being bamboozled into expensive, unproven and possibly risky treatments. Here are some of the examples I found where funding is sought for the use of stem cells to treat a variety of conditions (links to the source pages are in the first couple words of each quote; minor tidying of formatting and spelling but these are largely copy-pastes from the original pages).
Cerebral palsy
Recently we found a Dr. here in San Antonio that does nonembryonic stem cell treatment. This treatment has a 77% chance success rate in patients with cerebral palsy. This treatment could help heal Lia and she could possibly be off all medications. The procedure is $4,500 and insurance does not cover this procedure.
And:
Dawid and his parents are humbly asking for donations because he is a candidate for Stem Cell Treatments [for cerebral palsy]. The Doctors think this can help him to be much more functional and independent.
But, according to the National Institute of Neurological Disorders and Stroke:
Stem cell therapy is being investigated as a treatment for cerebral palsy, but research is in early stages and large-scale clinical trials are needed to learn if stem cell therapy is safe and effective in humans.
ALS
We are now trying to raise money for Jeff to get treated [for ALS] with his own stem cells. Please help in funding his first injection in Florida which is $10k. The harvested cells that will grow will be injected out of country. Every time they do another injection of his own cells it will be around $2k. We a praying this will at least slow the process of this disease and rebuild back some of the lost muscles and nerves.
From the Emory University School of Medicine:
ALL stem cell therapies for ALS are currently in the experimental phase, and there is no conclusive evidence that any of the stem cell procedures now being offered provide benefit for patients with ALS.
“Chronic Lyme”
A treatment that a lot of [apparently, “chronic”] Lyme Disease patients have had great success with and Okie would like the option to consider would be Stem Cell Therapy. This would not be covered by insurance at all so majority of the goal of this would go towards providing him that opportunity. . . This would help his body continue to heal, repair and help his Immune system so he can eventually get off of all of the medications and supplements.
And:
My wife, Ronda, has [again, apparently “chronic”] Lyme Disease and co-infections. She was diagnosed almost 3 years ago after 2 years of endless trips to doctors with no answers for her list of 50+ symptoms. . . In July, we are traveling to Germany to do an autologous Bone Marrow Stem Cell treatment [for $50,000] that will help to heal and repair these areas of her body in hopes that she can once again live a normal life.
According to the NIH’s National Institute for Allergy and Infectious Diseases, the only proven treatment for Lyme disease is antibiotics. “Chronic Lyme disease” is not a legitimate medical diagnosis, meaning those getting stem cell treatments for it are doubly deceived by practitioners.
Multiple sclerosis
It is our prayer that this Stem Cell Transplant will put Alexa’s (rapidly progressing) MS into remission as it has done for many people all over the world.
And:
My request from you is support for Stem Cell Therapy. I found a clinic in Los Angeles and met the Chief Science Officer at a convention in 2017. This treatment is currently not FDA approved; however, I’ve heard tremendous stories of those with MS who’ve had it done with major improvements.
The National Multiple Sclerosis Society advises:
Although cell based therapy has generated a great deal of interest and holds promise, the field is in its infancy and much more research is needed before cell based therapies become a MS treatment option.
Spinal cord injury
I met Dr. Badday. (http://www.drhasanbaddaymd.com/) a man who looks at alternatives to opiods. Ways to manage pain. He, being a strong supporter of new technologies, recommended stem cell therapy. Donated Umbilical stem cells, NOT anything un-ethical. With the severe damage done to my nervous system, he feels this is a way to regenerate and repair the damage caused by my accident.
And:
In 2011 Skye Morris was life-flighted to Harborview Hospital after a life-threatening accident while participating in an equestrian competition. Initially, we didn’t know if she was going to live through this and didn’t know the extent of her Brain Injuries We are so grateful that she is alive, however, she is confined to a wheelchair and communicates using her IPad. . . Stem Cell Replacement Treatment looks promising and has given us hope. …
Actually, while stem cell therapy for spinal cord injury is promising, it is still in its early stages and remains unproven.
Arthritis
As most of you know, he has been suffering from Osteoarthritis and Rheumatoid Arthritis for several years. These diseases have progressed to a point where he is in constant pain and is unable to do many of the things he loves to do.
After researching many options, I have found one that looks extremely promising. Of course it is not covered by insurance but if this therapy is successful which there is over a 75 percent chance that it will be, it could greatly improve the quality of my dad’s life by easing his pain and actually helping his cartilage to regenerate with the help of stem cells.
Here’s Dr. Knoepfler’s view:
stem cells for arthritis from clinics directly marketing to consumers is most often going to be a big waste of money for patients. This is not to say that there’s no hope of stem cells for arthritis or specifically for knee arthritis, but caution is in order right now on this front.
And, unfortunately, so on.
What about the fundraising sites?
Neither GoFundMe nor YouCaring caution fundraisers or donors about unproven medical treatments. Should they?
In case it makes a difference to you in answering that question, YouCaring does not take a percentage of donations to crowdfunding campaigns. GoFundMe used to charge 5% but has stopped that practice for personal fundraising. Transaction fees are charged by processors on both sites and both rely on donations to the site support their services.
As one “Viewpoint” author commented in JAMA last year about crowdfunding for medical treatment:
Many of the legal and ethical issues that make this problem so challenging remain largely unexplored. To this end, further discourse and empirical research around this topic is long overdue, and will only increase in importance.
The Washington Post asked Dr. Jeremy Sugarman, a bioethicist at Johns Hopkins, who suggested
crowdfunding sites might be able to help rein in some of the problem by recommending that patients and families seeking funds consult with their doctors about treatment claims, or refer them to other reputable resources.
And, I would add, warn donors to do some research too.
In a written statement to the Post, GoFundMe said
it removes any campaigns that violate the site’s service terms but that it allows pleas for funding medical treatment that is experimental and part of legitimate research. The company says it refunds donors if misuse is detected.
None of the examples the researchers found or that I list are “part of legitimate research.” Does that mean GoFundMe would return donors’ money? Probably not, because the policies of both GoFundMe and YouCaring seem to address only those crowdfunding campaigns where the beneficiary is misleading donors, not those where the beneficiary himself is misled by others.
A warning about unproven therapies with guidelines on evaluation of medical claims would be a beneficial addition for both crowdfunders and donors, but the real problem lies upstream. Until the FDA and state regulatory boards up their game in fighting unproven claims, the stem cell business will continue to boom and desperate patients will find a way to pay for it.
For legitimate information on stem cell therapies see:
- FDA Warns About Stem Cell Therapies
- The Niche: Knoepfler Lab Stem Cell Blog (includes information on legitimate stem cell trials and a patient’s guide to treatment)
- National Institutes of Health: Stem Cell Information
