There are now so many clinics selling non-FDA approved stem cell offerings across the U.S. that tens or hundreds of thousands of patients are at risk. How did we get here?
What if we had a way of understanding how stem cell clinics spread across the U.S. in the first place? For example, an animated map showing the spread of stem cell clinics selling non-FDA approved “treatments” across the U.S. would be useful. With publication of our new paper, the recent work of Leigh Turner and I provides just such a map (also see video below).
When Leigh and I published our 2016 Cell Stem Cell study showing almost 600 stem cell clinics selling non-FDA approved offerings across the U.S., many people were surprised at the extent of this for-profit, direct-to-consumer clinic industry in America operating without FDA approval. The first question many readers asked me was similar, “Where did all these clinics come from and when did they first pop up?” The same kinds of questions arose from the piece that came out just a bit later from a team led by John Rasko.
Our newly published Regenerative Medicine paper including the animated map provides a compelling visual answer.
As of 2008 we didn’t find evidence in Internet archives of stem cell clinics marketing on the web. Within the first few years after that there were just a handful of clinics (see screenshot above of 2010) and the early ones were in California, Florida, Texas, and Colorado, but in subsequent years their abundance exploded across the country. In just the last few years, about 100 or more new clinics have popped up yearly on the web leading to today’s seriously problematic situation.
A good portion of this wild growth of clinics selling potentially risky stem cells is attributable to lack of FDA oversight actions in past years along with aggressive expansion efforts by many of the clinics and clinic suppliers to raise profits by spreading in a way reminiscent of franchising. Imagine if the Obama FDA had taken some substantial action in 6-7 years ago on the non-compliant clinics? I doubt that we’d have the scope of problem that we have today. Leigh, I, and others have been pushing the FDA for a very long time to act, but without much luck.
Will the new Trump FDA more actively and successfully rein in the clinic industry so less risk is posed to patients and the stem cell field overall? So far what I’ve seen is hopeful signs, but it’s a huge task that the agency has indicated they may not have the bandwidth to tackle in total. Still, the FDA needs to do relatively more and I’m hopefully they will. Even acting on say the top 20 firms that the agency views as the highest risk could have a positive domino effect.
In our new paper, Leigh and I also found that clinics marketing certain conditions and types of stem cells exhibited specific trends over the years. For instance amniotic stem cell clinics, while lagging behind bone marrow and fat stem cell clinics in numbers, show a sharp upward trend. This spike fits with increasing mainstream media advertising efforts by amniotic clinics.
While Leigh and I documented the nearly 600 clinics as of 2016, my sense is that there are likely to be upwards of 700 clinics today. What will the map of stem cell clinics look like in 2019 or 2020? What do you think? Fewer? More? Or about the same number of clinics? What would similar temporal maps of clinics in other countries look like?
The research we’ve done and published in the last few years hopefully will provide a foundation for future efforts to get additional hard data on the for-profit stem cell clinic arena including the direct-to-consumer marketplace that in my opinion poses the highest risks both to patients and the stem cell field.
1 thought on “Animated map video shows wildfire spread of US stem cell clinics lacking FDA approval”
Looks like the FDA’s bark is bigger than it’s bite.
“Our phones are ringing off the hook,” said Dr. Comella. “Public demand is ramping up quickly, as Americans invest in educating themselves on stem cell therapy and alternatives to opioid protocols for chronic pain.
“We have seen significant revenue increases for the past six straight quarters and market demand is starting to drive revenue even further,” said Mike Tomas, Chief Executive Officer of U.S. Stem Cell, Inc. “We look forward to sharing news of our continued growth and are pleased to see 2018 is starting off so well with the recent milestone of reaching 10,000 units sold for our proprietary AdipocellTM product,” said Tomas. “We believe this is an indicator of continued growth to come.”