Yesterday, one of the people following this blog shared a story that had just hit the papers in California: Mark Berman, MD, the co-founder of Cell Surgical Network has died. It was a little strange because the story was that Berman had died in mid-April, but that the family hadn’t previously made a public announcement. The cause of death was Covid. He apparently contracted it in January and had stopped seeing patients.
Does this have any effect on the FDA’s pending case against him?
Beyond the obvious that death is the ultimate unbeatable personal defense, his death will have no effect on the case. His partner Eliot Lander is still a defendant in the case, as is their business Cell Surgical Network (“CNS”). Also, the relief sought is a permanent injunction stopping the defendants from using their SVF (and related products) on patients. There is no monetary damage claim in the case, as far as I can tell, so Berman’s estate is not a potential target. The judge will note Mark’s death in his opinion, but apart from that footnote, the decision will be what it was always going to be.
And to remind everyone what the critical issue is
You will recall from prior posts that Judge Bernal denied the FDA’s motion for summary judgment. His decision strongly inferred that he was going to rule in the Defendants’ favor (at least on the core question) if, as he indicated the material removed was the same material that was reimplanted. (It’s more complicated than that, but I explained all that in prior posts).
The rub was that a Florida federal judge granted summary judgment to the FDA on almost identical facts in the US Stem Cell case. Ok, different federal district courts can come to different conclusions. Nothing unusual about that. However, after the CSN trial, the Eleventh Circuit affirmed the Florida district court’s opinion. So, now there is somewhat persuasive but not binding authority that the SVF (stromal vascular fraction) stem cell product used by both US Stem Cells and CSN is an unapproved new drug (and is misbranded and adultered, which is what I refer to as the trifecta of FDA illegality).
So, the question is whether Judge Bernal is going to change his view in light of the Eleventh Circuit’s decision. For what it’s worth, I thought the judge was pretty hard on the government during the trial.
A few words about Mark
I knew and interacted with Mark over the years, from the time he first got involved in the stem cell field. We spoke and attended some of the same seminars and events. On occasion, we would speak on the phone and email about general issues, about his case, and some of my stem cell cases.
I have encountered many medical mavericks over the past few decades. That is basically what I do, i.e., work with medical mavericks and their patients. Not coincidentally, the title of my (so far) only book is “Galileo’s Lawyer”). Like most medical mavericks, Mark had an unshakable belief in what he was doing. He thought he was helping his patients and collecting the data to prove the benefit of SVF.
And speaking of collecting data
About five years ago, we both were invited and attended a small meeting of mostly conventional stem cell thought leaders from around the country. All the big acronym stem cell organizations were there, (you know, the self-appointed, self-important protectors of stem cell research and the protectors of the “public”), along with some of the top academic research institutions. On the other side were three docs from the unregulated stem cell business, (Mark, his partner, Eliot, and Chris Centano). I was there for the legal side of the unregulated clinics. All twenty-five or so participants gave a little talk about their perspective and how to advance the field and help make treatments available sooner. The specific focus was whether to try to integrate data from the unregulated stem cell clinics into the conventional stem cell registry.
Mark talked about the software data collection program he and Eliot developed for use by CNS’s affiliated doctors, all the data he could capture, and the checks and double-checks.
You have to understand, to this group, he was basically a pariah, “experimenting on patients for profit” was (and is) the common mantra. Despite his pariah status, I think the stem cell institutionalists were blown away by his presentation and what his data collection system could do and capture.
Why do I think this? After his presentation, all these big institutional players wanted his company to give his program to them all so they could use it. Apparently, it was a quantum level more sophisticated than the way these august-lettered groups (and their affiliate organizations and academic institutions) were collecting data. Mark pointed out that the program was proprietary and very costly to create and keep fresh. But as I recall, he offered to license it to them, or maybe they should all join CSN! The guy had chutzpah.
From my side of the street, Mark was a medical pioneer and hero. He was a bold thinker, (though sometimes bumptious). He had an unwavering belief that stem cell treatment should be a much bigger part of medical therapeutics than it is and that it is being held back by narrow-minded institutionalists. He had this dream and plan to create an international cadre of hybrid, for-profit, private stem cell clinics which would collect and publish data about the results of the treatment. In that regard, it was a direct challenge to the medical epistemological notion that clinical trials had to be double-blinded and have a control arm (one group or cohort receiving another or no/placebo treatment). Houston cancer doc Stan Burzynski created this model back in the 1980s.
Mark and Eliot turned that idea into a franchise model to supercharge the data collection efforts, with the goal of publishing data faster and better than the institutionalists using the FDA clinical trial model. Because of the FDA’s lawsuits, I think this iteration of this hybrid model will not survive, at least with this type of stem cell product.
And I doubt that any new version will take its place in the stem cell field because of the FDA’s definition of “minimal manipulation” and “homologous”. Basically, you can’t do anything other than wash human tissue (HCT/Ps) and you can only use the product for the very specific purpose it had in the body. Anything else turns your own body part into an unapproved new drug (as crazy as that may sound). Such is the state of the law now, depending on what Judge Bernal says in his (eventually) forthcoming opinion in the case. Still, I am a strong proponent of the model.
Further, to tie in another of my areas of interest, I would like to see that model adopted in off-label covid treatments programs, but that’s another story.
RIP Dr. Mark Berman, a formidable medical pioneer. You will be missed.
Rick Jaffe, Esq.