Thoughts on death of stem cell clinic leader Dr. Mark Berman

Over the past dozen years as I've written about stem cell clinics here on The Niche I've gotten to know many of those running the clinics including Dr. Mark Berman of Beverly Hills.

It was therefore kind of a shock to learn that Berman died of last month. Michael Hiltzik of the LA Times reported yesterday that Berman's death was related to COVID-19. I haven't seen any obituary yet despite Berman reportedly dying about a month ago.

I always thought of Berman as this robust physician with limitless energy. However, COVID has taken about a million American lives and many of those deaths have seemed unexpected.

Dr. Mark Berman and Cell Surgical network

Dr. Berman and his business partner Dr. Elliot Lander have run the largest chain of unproven stem cell clinics in the U.S. for many years. This controversial chain, called Cell Surgical Network, is headquartered out of Beverly Hills.

I've written about Cell Surgical Network many times and interviewed Lander and Berman more than once. The network sells unproven "fat stem cells" for many different health conditions. These cellular preps from adipose tissue are also called stromal vascular fraction or SVF. The FDA has defined SVF as a drug requiring premarket approval. Berman and Lander did not have that approval, but disagreed that the material was a drug.

I have been an outspoken critic of Cell Surgical Network. Even so, our many interactions over the years were almost entirely cordial. I think we only talked once on the phone, but Berman was polite and friendly.

Berman proposed to treat COVID with stem cells

There had been a sense from the clinic network leadership of the almost limitless potential of the fat-based cellular preps to treat human diseases.

I was skeptical due to lack of strong data for almost any condition.

Most recently they had proposed treating COVID-19 with stem cells and may have already been testing such an unproven intervention on patients, but I'm not 100% clear on that.

More broadly, the idea of cell therapy for COVID has captured some scientists' hope. However, a student and I found that most clinical trials of cell therapy for COVID were not designed to provide robust assessments of safety and efficacy.

Some have also been proposing the idea of stem cells as a preventative measure against getting COVID-19. There are no data to support that idea.

Cell Surgical Network future without Berman

What happens now?

Will the big network chain be able to continue largely as is without Dr. Berman?

A major court case here in California is pending on an injunction against Cell Surgical Network sought by the FDA. The Cell Surgical Network lawsuit could go either way. Much but not all of the case centers on the question of whether SVF is a drug.

Even if the clinic network prevails, things will be more challenging without Berman. My sense was that he was a huge source of energy and enthusiasm.

While his son Sean has been active in the stem cell space, he is not a physician. Who will inherit Dr. Berman's share of Cell Surgical Network and the local stem cell clinic(s)? I don't know if Dr. Berman had more than one child.

The FDA will almost certainly appeal if they lose this California court case. With the appeals court siding with the FDA in the other similar case in Florida, the agency might ultimately prevail here in California federal district court too. We just don't know. That uncertainty could be hanging over things for the network moving forward.

If the network loses the California injunction case they might appeal. In that scenario it's going to be much harder to imagine them continuing on the same large scale in some modified form without Dr. Berman. In that scenario, is it possible they wouldn't appeal the ruling?

However the court case turns out, more broadly the unproven stem cell clinic world has lost arguably one of its most passionate advocates.

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