Since the mid-2000s, clinics are expensive, unproven stem cell treatments for all patients desperate enough to believe their claims for treatment for everything from arthritis to autism. At first these clinics work almost entirely overseas. But for ten years, they have flowered in the United States Regulators without much fight, even though the experimental therapies they use have been linked serious infections, several cases of blindnessand one the patient's death.
But the federal government is no longer on the sidelines. Earlier this month, the US Food and Drug Administration won a landmark lawsuit against American stem cell, a company that runs three large clinics in Florida where at least four patients have been treated would have blinded The decision of injunction On June 3, the agency has the power to prevent the private clinic from injecting patients with a cellular cocktail centrifuged from their own fat liposuccée. This controversial practice is common in clinics across the country. Unless the decision is overturned on appeal, this confirms the FDA's position that anyone who acts in this area is illegally peddling an unapproved drug.
In the past two years, the FDA has intensified the application of these clinics. It has also been a collection of clinics based primarily in California called Cell Surgical Network (this case is ongoing). But he faces a tough battle against the viral marketing tactics that the burgeoning stem cell industry is employing to keep patients flocking in.
"Rather than melting, business is growing – it's the anomaly," says Leigh Turner, a bioethicist at the University of Minnesota, who studies the stem cell industry. In 2016, I calculated that 570 clinics offered untried treatments to stem cells in the United States. In 2018, I reported in a study The number had climbed to 716. Today, Turner is comfortable to say that the United States has crossed the threshold of 1,000 clinics. "Despite the rule changes and public hearings, as well as more inspections, warning letters and lawsuits, the market continues to grow rapidly."
It is possible that there is just one shift; It could take years for these FDA ripples to reach the market. More likely, says Turner, is that there is too much money to be done with too few potential consequences. The FDA can not expect the 1,000 clinics to submit applications and the fines that the agency may charge in the event of non-compliance will likely be quickly recovered by clinics charging between 3,000 and 15 $ 000 per treatment.
Then there is the ease with which stem cell clinics reach potential patients online. They advertise their treatments directly to customers almost exclusively on the Internet, flooding their search on Google with vague but hopeful promises. Often this is the patient's testimonial video, one of the most effective marketing strategies used by stem cell clinics. You can find them on the websites of clinics, blogs, Facebook groupsand Youtube.
A study of 159 of these videos, published this week in Stem Cell Reports, found that in 95% of cases, patients were praised for the way that stem cells helped them – pain reduction, increased mobility, stopping seizures, recovery in strength and improved vision, between other effects. Only 10% of the videos mention potential risks. On average, the videos attracted an audience of 3,546 views. Most seemed to have a very low budget, but no special effects were required to convey the passion felt by patients. There are patients with multiple sclerosis, 11 of whom have triumphed in front of walkers and parents in tears who can not even tell how happy they are with the results of their children's treatment.
The authors of the study wrote that by producing these extremely personal and emotionally powerful videos and sharing them with potential patients, clinic providers could develop an appealing message and avoid drawing on drawbacks. "Compared to educational videos from reputable scientific organizations, videos presenting patient testimonials will likely have a broader reach and a significant impact on health behavior," they concluded. That's a problem, not because anyone suspects that these patients are lying, they really felt much better after the treatments. But there is no way to know if they are only feeling the placebo effect. Anecdotes invite you to narration, but they are not data.
YouTube itself has left its policy on such ambiguous videos. Under the section Prohibiting videos that make exaggerated or misleading marketing claims, the company gives the example of a "miracle cure that can cure a chronic illness such as cancer". In some testimonial videos commented on by WIRED, patients explicitly cite stem cells as a miracle, while resorting to biblical analogies about Jesus healing the blind. A YouTube representative did not respond to WIRED's inquiries at the time of publication.
To ignore the rules would not be quite wrong for the vast majority of stem cell clinics. At least a dozen and a half have registered Clinical trials "sponsored by the patient", studies that pretend to be legitimate science while charging high fees. Another common strategy for creating a superficial glow of scientific rigor is for patients in stem cell clinics to complete quality of life surveys and publish their findings. pay to publish predatory journals.
That's why, just like Turner, we are only very cautiously optimistic that the latest FDA victory will bring about a long-term change. "It's a significant step and I'm comforted by the fact that people are attentive," he said. "But once the spotlight disappears, the market will still be there, and from what I can tell, the damage that results from it seems to worsen."
More great cable stories
(tagsToTranslate) stem cells (t) health (t) regenerative medicine</pre></pre>