Patients are promised revolutionary therapy, only to find they’ve wasted their money—or worse.
It's a nightmare story: Three women pay tens of thousands of dollars to a South Florida clinic for unproven "stem cell therapy," only to end up blind. At least one thought she was part of a clinical trial—undergoing an experimental treatment, certainly, but presumably with adequate safeguards. Instead, the women found themselves in a much murkier situation, receiving dubious treatment at a clinic that was almost entirely unregulated. The results, in this case, speak for themselves, and critics warn that there's a large and growing problem with patients being promised revolutionary "stem cell therapy," only to find they've wasted their money—or worse.
"It's a big problem because these stories about stem cells are emerging everywhere, and the phrase 'stem cell' now is sort of becoming a proxy for 'cutting edge' and 'breakthrough miracle.' It's become a marketing tool to sell unproven therapies," says Tim Caulfield, research chair in health law and policy at the University of Alberta and a frequent critic of medical hype.
As Caulfield tells it, stem cell research has genuine potential—stem cells are often touted as both "master cells" and "blank slates," capable of developing into any cell within the body. They promise regeneration, rejuvenation, and replacement of the most basic organic structures; rolling back your cells sounds like a scientific gloss on the fountain of youth, and that's a powerful, if simplistic, message.
But science moves slowly. Researchers have been working with stem cells for a long time, but thus far the Food and Drug Administration has approved only one kind of stem cell treatment. Yet clinics around the world offer unregulated procedures, typically using fat cells that are removed from the patient's body, treated, and injected back into it—the process that blinded the three women in South Florida. (The only FDA-approved treatment uses cells harvested from the blood or bone marrow, not from fat.)
Many clinics aren't shy about implying they can provide miracle cures, either. Nearly ten years ago, Caulfield and his co-authors published a study of how clinic websites worldwide described their stem cell treatments. The portrayals, they found, were "optimistic and unsubstantiated by peer-reviewed literature." Researchers were concerned: The emerging trend of "stem cell pilgrimages" to undergo bogus therapies wasn't just wasting patients' money, but creating the potential for real and lasting harm, both to patients and to the reputation of stem cell research.
Yet when they revisited the topic five years later, not much had changed. "In fact, it had gotten worse, in the sense that these clinics were still representing these therapies as effective, still representing them as relatively risk-free," Caulfield says. He suggests that social media, as with so much else, has helped the spread of bad information, making it that much more likely that someone desperate for a medical miracle will be tempted by pseudoscientific treatments. That's the kind of environment that enables three men to make more than $1.5 million peddling false hope to patients with cancer, multiple sclerosis, and other autoimmune diseases. Or spawns around 20 clinics in Tijuana, Mexico, offering adult stem cell therapy, claiming to be running clinical trials while also emphasizing—implicitly promising—predictably happy results.
It's not just social media that's to blame, of course. Caulfield believes researchers have to take more responsibility for how their work is portrayed in the popular press. Public interest in stem cell research has shifted from legal and ethical questions (is it moral to use embryonic stem cells, for example, and if so, how should it be regulated?) to clamoring for the treatment itself, and Caulfield believes media coverage can give readers false hope. He and a co-author found that 69 percent of news reports that provided timelines for stem cell research suggested the benefits were five to ten years away, or even sooner. "Which is lightning speed in the world of biomedicine," he says.
Besides offering extremely optimistic timelines for the translation of research into therapy, journalists can mislead readers about the proven results of stem cell treatments. Caulfield points to the Gordie Howe story as a frustratingly perfect example. Howe, the hockey legend who played the bruising sport until he was 52, suffered a stroke in 2014, followed by other health problems that left him very near death. His family, short on options, sent him to Tijuana for stem-cell treatment. His recovery was nothing short of miraculous; his son was optimistic enough to hope Howe would be even better than he was before the stroke.
It was a feel-good story for sports fans—for anyone, really. When Caulfield tried to place Howe's treatment within the larger issue of stem cell tourism, former sportscaster Keith Olbermann responded by tweeting, "What's next from you, you soul-less bastard? Coming out against vaccines?" (Caulfield responded that he'd spent his career supporting stem cell research and fighting pseudoscience.) Much of the popular press followed Olbermann's lead, taking what Caulfield suggests was an overly credulous approach to Howe's story, because who wants to be the soul-less skeptic? And Caulfield's subsequent analysis found that tweets about the story were overwhelming uncritical, celebrating Howe's recovery without noting that the treatment he'd received was unproven.
Today this sounds like an all-too-familiar problem: "fake news." And indeed, the confusion over what we actually can do with stem cells led the International Society for Stem Cell Research (ISSCR) last year to issue guidelines cautioning researchers against letting their work be misrepresented in the public eye. Caulfield helped author those guidelines and, though he apologizes for how trite it sounds, believes scientists need to be a part of the broader conversation about their work. "We need to be sure that we counter misinformation when we see it in popular culture and when we see it in social media," he says.
Intertwined with that issue, though, is the lack of regulation that allows clinics to exploit patients' ignorance. The Food and Drug Administration has largely been hands-off when it comes to stem cell clinics. Because the procedure extracts cells from the patient's own body and only puts them through minimal treatment before reinjecting them somewhere else, the FDA does not consider it a drug treatment. It's outside the agency's purview.
But clinics have proliferated, and safety concerns have increased. A study published last year in Cell Stem Cell found that 570 clinics across the United States offer stem cell therapies with little to no oversight. "Such commercial activity suggests that regulatory agencies must better oversee this marketplace," the authors noted. Last year the FDA contemplated a crackdown, only to receive complaints from clinic operators and patients who believe the agency would be shutting down access to life-saving treatments. Since then, the issue seems to have stalled. With a new administration in power, it's not likely to move forward, either. "I'm not optimistic that the FDA is going to get involved in regulating this in an aggressive way, which is unfortunate," Caulfield says.
That leaves patients in a tough position, in a place where misinformation meets a lack of oversight. Caulfield encourages scientists, journalists, and educators to promote good information that cuts through the noise, even for people who may be in desperate need of a medical "miracle." It's a slender hope, that responsible, scientifically grounded knowledge can push out hucksterism. In the meantime, for those pinning their hopes on unproven stem cell therapy, the most useful advice is caveat emptor.
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