November 30, 2020

The Niche

Knoepfler lab stem cell blog

FDA under Scott Gottlieb goes large on stem cell clinics with crackdown likely

The US has been bursting at the seams with unproven stem cell clinics for years, which in my view necessitates some kind of bold action by the FDA and other governmental agencies so I’ve wondered what new FDA Commissioner Dr. Scott Gottlieb would do on this front.

The lead up to and beginning of a likely crackdown

Dr. Scott Gottlieb
Dr. Scott Gottlieb, Commissioner of the FDA, has led a pronounced increase in activity on unproven stem cell clinics so far during his tenure.

A subset of these clinics are particularly risky and egregious in their behavior. While this subset constitutes may be “only” one or two hundred such clinics out of maybe a thousand such firms today, they are responsible for a disproportionate share of risk to patients. Thousands of patients are at real health dangers just from these clinics. These clinics also are financially harming vulnerable patients and their families as well. Furthermore, they also pose a threat to the legit stem cell field.

While possible stepped up action by the FDA has been called for and speculated about for years including by me here on this blog and in publications such as my piece in Cell Stem Cell earlier this year, it seems the FDA under Scott Gottlieb means business this time. My sense is that we are most likely witnessing the beginning of a real crackdown on the narrower subset of the riskiest few dozen stem cell clinic firms out there.

What’s different this time?

We’ve seen Gottlieb’s FDA issue more warning letters already. Not a flood of them, but more than in past years. Also this FDA has used much bolder language on stem cell clinics. Most importantly, the latest warning letter to umbilical cord supplier Genetech related to it and marketer Liveyon having been involved in documented serious adverse events in many patients was accompanied by a press release from the FDA that was historic in some ways. For instance, the agency indicated it’s going to be sending out letters potentially to many stem cell firms, focusing on those posing the greatest risks.

These letters, which admittedly are not official warning letters, still by the sound of it should be interpreted by the 20 or so clinics that get them as warnings of a sort. It makes sense that FDA picked the clinics it was most concerned about to send these letters to rather than sending them to all of the nearly 1,000 clinics in the US.

The door is closing on clinics to get compliant

So, I’d say if you are one of the clinics that got such a letter, don’t be stupid.

Stop being non-compliant.

You are fully on the FDA and perhaps also FTC radar screens, and you can’t beat them. Even just to fight them in court will cost you millions of dollars and generate massive negative publicity. In some cases there may be risks of losing your medical license as medical boards shown signs of increased interest. You may even face criminal liability. If your product suppliers, other clinic operators, or additional people in your industry are telling you otherwise (e.g. arguing that you can fight and win) they are wrong. From what we’ve seen the past 1-2 years, the “senior” folks in the stem cell field are not giving others great advice plus if you use a product from a supplier, you cannot trust that that product is safe for your customers, putting both the customers and you at huge risk.

November 2020 (when the 3-year implementation period ends of new FDA guidance) is not so far off and I predict substantial FDA action on clinics prior to that for the riskiest clinics. Keep in mind that FDA does not have to wait until 3 years are up to take action on what it sees as risky stem cell clinic situations.

Genetech warning letter: 12 patients ended up in hospital

Take a look at that warning letter to Genetech. It is quite striking and disturbing. It documents how a dozen patients had serious adverse events from their umbilical product administered at stem cell clinics. They ended up in the hospital for long periods of time with major health effects:

“The FDA and the Centers for Disease Control and Prevention have received numerous reports of safety issues including those involving microbial contamination and are aware of 12 patients who received Genetech products from Liveyon and subsequently became ill due to blood and other infections caused by a number of bacteria, including Escherichia coli (E. coli), as described in a Morbidity and Mortality Weekly Report (MMWR), titled “Notes from the Field: Bloodstream and Joint Infections in Patients After Receiving Bacterially Contaminated Umbilical Cord Blood-derived Stem Cell Products for Non-hematopoietic Conditions — United States, 2018.”

If you go to that MMWR webpage it’s a sobering overview of the catastrophe caused here. Twelve patients seriously harmed by stem cell clinic offerings. It’s not surprising there are already lawsuits related to this particular train wreck. You can also see how a “stem cell” supplier is in a sense potentially much more dangerous than a single clinic because they might supply many clinics with a contaminated or otherwise risky product. However, some clinics see hundreds of customers a year so they can pose major risks too.

Looking to the future

I expect that some clinics will keep on doing what they’re doing anyway, but if I had to bet I’d say now may be one of the last chances for certain firms to get while the getting’s good.

Finally, I expect the FDA action involves not just birth-related clinic and supplier firms, but also many adipose stem cell clinic-related firms. These “fat stem cell clinics” are clearly non-compliant under new FDA guidelines and some have already been linked to numerous patient harms.

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