As I broke the news yesterday, the high-profile fat stem cell clinic firm U.S. Stem Cell (USRM) just lost a groundbreaking court case.
Here is the FDA’s official reaction today to the court ruling.
Also, since the ruling major media have been covering the court ruling. Here are some examples:
- From the Washington Post from William Wan and Laurie McGinley we have FDA wins groundbreaking case against for-profit stem cell company.
- Michael Hiltzik of the LA Times has a blunter headline. Backing the FDA, a federal judge delivers a blow against bogus stem cell clinics.
- The New York Times headline for Denise Grady’s piece is FDA Can Act Against Stem Cell Clinic, Judge Rules
Here is stem cell clinic attorney Rick Jaffe’s take on the news on his blog.
USRM is a publicly traded company and not surprisingly its stock has tanked today, losing about half of its value just so far this morning (see screenshot). It’s an understatement to say that the financials of the company are uncertain moving forward. One slight glimmer on the financial front is that it appears the SEC investigation of the company may be winding down without any action.
So far I have not seen an official response from USRM to the court decision, but if I do, I will try to post it. Update: I now see an updated version of the NYT piece with this USRM quote:
“While we believe there is substantial evidence to prove the efficacy of this protocol, we must immediately comply with the court as we review the decision,“ the company statement continued. “US Stem Cell Inc and US Stem Cell Clinic will continue to operate business as usual, but will no longer offer the adipose/SVF procedure.”
Can we learn anything from past statements?
About a month ago on Twitter, an account that appears to be USRM leader Kristin Comella seemed to me to be invoking some kind of supposed nefarious plot involving the FDA, Michael Cohen (yes, that Michael Cohen, who was formerly Trump’s attorney), and oddly the pharma company Novartis to specifically stop USRM, or what Comella referred to as “my stem cell treatments”. See screenshot of the Tweet.
I haven’t seen any evidence to support this in my opinion wild allegation and she lost her case in court yesterday, although an appeal is likely.
In the big picture, this ruling is really about much more than just the company USRM or its leadership.
Overall this court order makes it likely that many other fat stem cell clinics will shut down, even if admittedly some will continue too until they are directly forced to stop.
Furthermore, in my view now it’s now more likely that the big fat stem cell clinic chain Cell Surgical Network and its co-defendants in the other major federal lawsuit by the FDA will also lose. The main elements of that still pending case are in my view similar to the USRM case.
But I’m not a lawyer so what do I know, right?
Still, it’ll be important to see if a significant fraction of the scores of clinics that are part of Cell Surgical Network abandon fat stem cell injections in the relatively near future given the USRM court outcome even if the Cell Surgical Network case is still pending.
More broadly, do some of the hundreds of American fat stem cell clinics then switch over to the equally dubious or worse perinatal “stem cell” universe of direct-to-consumer offerings?
Maybe some will adopt unproven bone marrow offerings instead, which are at least often FDA compliant depending on how they are prepped and used?
Do others solely focus on platelet rich plasma, which isn’t really even a stem cell therapy at all?
Unproven stem cell exosomes?
Homeopathy?
Leave the U.S. and still offer fat stem cells?
It’s clear that some of these folks are going to try to continue to make money from unproven biological “therapies.”
Overall, still this court verdict news is a major step forward for science-based stem cell and regenerative medicine.
I personally have two very good friends who received treatment at US Stem Cell Clinic. One now no longer needs knee replacement and the other was halfway through treatment when the FDA shut them down but he saw a 30% improvement in lung capacity’s after years of battling COPD from Vietnam era related lung damage. Interestingly the US medical and pharmaceutical system was not able to do ANYTHING for these two people except charge exorbitant amounts of money for what amounts to “pain management”. They are now free. One happens to be a very good friend of the President … I hope he is listening and calls off his FDA hounds!
I think the definition of a drug is the main point.
Do I detect some reporting bias here? The judgement wasn’t about “unproven” treatments, it was about US Stem Cell Clinic, LLC not following cGMP standards and not labelling their product.