FDA’s crackdown on unproven stem cell therapies isn’t working

 In 2019, the Food and Drug Administration won a major victory when a judge shut down a clinic in Florida claiming to treat everything from back problems to heart diseases with stem cells. The decision was additional juice for the FDA to regulate the growing industry, which sells risky, unproven stem cell procedures as cure-alls.

But despite the high-profile success in Florida, the problem has gotten worse. There are more than four times as many businesses in the United States advertising unproven stem cell therapies now than there were four years ago, according to an analysis published today in the journal Cell Stem Cell that used online searches and Google Maps to find clinics. That’s despite a common perception that there’s been an FDA crackdown on the clinics offering these procedures, says study author Leigh Turner, a professor of health, society and behavior at the University of California, Irvine. As Turner sees it, with nearly 1,500 businesses operating 2,754 stem cell treatment clinics in the US in March 2021, whatever warnings regulators have issued to try and rein in the industry aren’t working.

“It kind of raises the question, is there really meaningful regulatory oversight at all?” Turner says. “There is on the books, but in reality, does it exist?”

Stem cell therapy, a broad term covering any treatments that use specialized cells that can morph into any cell type, has some real, evidence-based applications. Stem cells are used to treat some blood cancers, for example. There are efforts to develop stem cell-based treatments for conditions like amyotrophic lateral sclerosis, and stem cells from patients in need of an organ transplant have been used to bioengineer one, lowering the risk of rejection.

But most of the other ways people try to use stem cells are unproven, experimental, and risky. Medical practitioners selling these treatments claim the cells, which are usually taken from patients’ own fat or from donated umbilical cords, can treat everything from joint pain to degenerative eye conditions. There isn’t evidence to back up those claims, and the supposed treatments aren’t FDA-approved.

And the products have a dubious safety record. People have gone blind after receiving unregulated stem cell treatments. Non-FDA-approved treatments have also been linked to kidney failure and bacterial infections. Unproven and potentially dangerous therapies have become so prevalent that in 2019, Google announced it would ban ads for them.

Many of the clinics promoting stem cell therapies argue that repurposing someone’s own cells does not qualify as a new drug product, meaning they don’t need FDA approval. But the FDA says the cells are processed and manipulated enough that they become a biological drug product that the agency has to oversee — an interpretation that was affirmed by the 2019 case in Florida. In addition to winning the case to shut down the Florida clinic, over the last few years, the agency has sent letters to dozens of businesses warning them that the stem cells they use need approval before they’re marketed. The Federal Trade Commission and states attorneys general have also sued clinics over deceptive advertisements for claiming they can treat diseases.

These high-profile actions haven’t stopped the clinics from proliferating. There were only 351 businesses selling unproven stem cell therapies in the US in 2016 when Turner first investigated the matter. Now, according to his updated analysis, there are around 700 claiming to treat orthopedic injuries alone. Nearly 100 businesses say they can use stem cells to treat erectile dysfunction, and 23 say they use stem cells for autism spectrum disorder — and that they administer them to children. Most clinics included in the analysis didn’t list prices, but of those that did, the average cost was $5,118.

Turner thinks the spike in businesses offering stem cell therapies might be because the practice became normalized over the past few years, even as federal agencies tried to crack down. In addition to stem cell clinics, the businesses advertising stem cell therapies included chiropractors’ offices, sports medicine clinics, and other medical or quasi-medical practices.

“There seems to be a kind of move that’s taking place where it’s not just a kind of a couple of rogue clinicians who are way over the edge,” he says. “It’s much more run-of-the-mill: podiatrists, chiropractors, and naturopaths have moved into this space.”

Stem cell treatments are profitable. The barriers to entry are low, and there’s a steady supply of people who are suffering from conditions that standard medicine doesn’t have good answers for. People with spinal cord injuries or chronic pain can be targets for businesses claiming they can cure these problems. And the rise in the number of businesses offering the treatments even in the face of FDA action shows that the odds of someone facing consequences are, on the whole, fairly low. It’s a risk many businesses appear willing to take. “I think some people see this as it’s an opportunity to make a lot of money,” Turner says.

That could continue as long as the regulatory landscape stays the same. Experts have been waiting for the other shoe to drop for years, Turner says. But instead, things have gone in the opposite direction.

An FDA spokesperson said in an email that the agency doesn’t comment on individual studies, “but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”

It’s not clear whether the agency will respond more decisively in the next five years or if the market for these products will continue to spiral, Turner says. “I do find myself wondering — when you have a marketplace this large that isn’t well regulated, can you ever get it under control?”

https://www.theverge.com/2021/11/4/22761580/stem-cell-clinics-fda-oversight