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.

7 thoughts on “FDA under Scott Gottlieb goes large on stem cell clinics with crackdown likely”

  1. My mistake. I may have been thinking about a bone marrow (allogeneic) transplant. Are these allogeneic mesenchymal stem cells approved to treat graft vs. host disease in the United States?

  2. In my opinion this blog post is in need of some serious perspective. It seems to consist of quite a bit of overblown rhetoric on the part of Dr. Knoepfler. Here are a few examples.
    “The US has been bursting at the seams with unproven stem cell clinics for years.” (“Bursting at the seams”, Dr. Knoepfler?) “these clinics are particularly risky and egregious in their behavior.” “they are responsible for a disproportionate share of risk to patients.” “These clinics also are financially harming vulnerable patients and their families as well.” “If you go to that MMWR webpage it’s a sobering overview of the CATASTROPHE caused here.”(Capitalization mine) ” there are already lawsuits related to this particular TRAIN WRECK.” (Capitalization Mine)

    All of these instances cited in this MMWR report have involved seemingly more of an allogeneic transfer of cellular material into a particular patient rather than the autologous use of a patient’s own body parts; the later of which seems a much safer option to me. And yes. I do realize that cord blood has some special immunological properties. Still the cases cited in MMWR do not comprise an autologous transfer of biological materials which is what most regenerative clinics primarily engage with their patients.
    These instances mentioned in the MMWR report should prompt therefore an investigation on the part of the FDA. Clearly, to me, though, the growing number of “stem cell” clinics nationwide are a testament to their overall safety and efficacy no matter how often times it is repeated that their practices are “unproven” or the institutions referred to as “predatory” throughout this blog.
    Now, at the risk of sounding as though I am blaming these unfortunate patients, I cannot understand exactly why someone would elect to utilize essentially more of an allogeneic procedure rather than an autologous one. Even in mainstream cancer therapies allogeneic stem cell procedures run the very real risk of graft versus host disease and other immunological side effects. And speaking of mainstream medicine, every year, about 1 in 100 patients receiving a hip, knee or other joint replacement may develop an infection after the surgery. For instance, hip and knee replacement operations are very invasive to begin with. But having to correct this type of a surgery gone wrong because of an infection seems a pretty invasive task involving further laboratory and imaging tests, antibiotics and additional revision surgery. (Ouch! And then the recovery…) 1% does not seem like a lot of patients. But, given the number of joint replacement operations that occur in hospitals and other clinics around the nation every year I’ll bet that 1% figure well surpasses the 19 cases mentioned in the above MMWR citation. And, four of these 19 MMWR cases seem also to have taken place in clinics that are decidedly not of the “stem cell” variety often times mentioned in a not so flattering manner on this very blog by Dr. Knoepfler…. This is what I mean by having some serious perspective in this blog.
    Example… (From the citation) ……” joint infections in four patients who had received injections of these same products at an ORTHOPEDIC CLINIC during February 15–August 30, 2018″. (Emphasis Mine) Orthopedic Clinic does not sound like “Stem Cell” or “Regenerative Medicine Clinic” to me.
    Finally, checking the website of the regenerative medicine clinic that I have frequented since 2014, they do not offer these cord blood like procedures to patients.

    1. @Douglas – Allogeneic mesenchymal stem cells are approved to treat graft vs. host disease in several countries. There is fair amount of literature available on the subject.

  3. Good points, Bill. There is no substitute for each person educating themselves as much as possible. My husband and I have learned that it may be necessary become our own advocates, lawyers, physicians, quantum scientists and neurotic-linguistic programmers so that we can navigate. Just for the reasons that you mentioned, we published a rudimentary website sharing our story to help others understand what they may be missing in case they are not doctors, attorneys or silver tongued salesman. http://Www.avoidthestemcellscam.com

  4. For every 20 friendly, informative letters the FDA sends out, 20 more labs and clinics will open. The recipients of these letters will file them in their circular filing cabinets and say, “We manufacture/administer a 351 product so these rules don’t apply to us.” Going after Liveyon won’t stop all the other lab/middleman companies who are distributing stem cell products nationwide. It just temporarily hobbled one of their major competitors, and Liveyon (or a reorganized “Liveyon”) will just come out with a new product line eventually anyways. FDA warning letters work through the fear of what might happen if the letter is ignored or challenged. Once the FDA is not feared, ignored, and subsequently challenged, it gets overwhelmed like it is now. It isn’t equipped to handle situations like this. No company making millions of dollars per month manufacturing stem cell products is going to stop doing anything until they are forced to stop. They will happily defend themselves for several years, even though they will almost certainly lose eventually. A chiropractor who can make more money than an orthopedic surgeon by administering simple injections to a couple dozen patients per month certainly isn’t going to stop anytime soon, not to mention doctors, nurse practitioners, and naturopaths who are raking in small fortunes treating conditions like autism.

    Has the FDA actually shut down a single manufacturer or clinic to date?

    The FDA is sending out these “letters” because they don’t have the bandwidth to anything else. They know who the major players are. They could inspect them and issue warning letters, and yet they won’t do it. Why is that?

    Here is a good example of the FDA being overwhelmed. https://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/medicationhealthfraud/ucm234539.htm

    Perhaps something similar will happen in the stem cell business where the FDA will catch as many as possible and issue a statement like, “Well, it’s illegal, possibly dangerous, and here’s a list of who we’ve caught so far, but we just can’t get everyone so beware.”

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