Stem Cell Video Flap: A Look at the California Firm Backing the 'Docu-Series'

A California physician deeply enmeshed in the national ruckus over a controversial, stem cell video has -- according to his web site -- "achieved world-renown as a pioneer in the area of stem cell research."

He is Mark Berman, one of the co-founders of Cell Surgical Network (CSN), which partly financed the lengthy, online video, "Healthcare Revolution." At least 12 scientists, other experts and institutions reacted with shock last week when they became fully aware of its approach and financing. They asked that they be removed from the film.

Mark Berman,  photo from Berman web site

One researcher called the video an "infomercial." Another said she was placed with "charlatans and thieves."

Berman's firm has been sued by the Food and Drug Administration as part of an effort to curb untested and potentially dangerous stem cell treatments. The number of dubious stem cell clinics has grown sharply in recent years. Estimates are that 1,000 exist nationally, with the highest percentage in California.

On Sunday he emailed the irate scientists and asked them to reconsider their requests for removal. None apparently did. 

What follows is a brief look at Berman's history and that of his firm, which has offices in Beverly Hills and Rancho Mirage, Ca., and about 100 affiliates nationwide and more abroad. 

But first, the text of his response to questions from the California Stem Cell Report about the video and its financing. The "docu-series" was produced by Bobby and Sara Sheehan and their firm, Working Pictures.

"I met Bobby and Sara when they came to interview me at my office for another project they were working on a couple years ago. We were commenting on all the amazing work being done in the field of cell therapy and stem cell research, yet all the surrounding controversy. A lot of this was due to people putting random unmatched cells into patients for a whole host of conditions and not adequately tracking the follow up. We thought it would be really important to show some of the world’s greatest minds, who have devoted, in some cases, decades to advancing this field, and highlight all the great work that’s currently being done to advance healthcare.

"I’m not sure what the entire series cost. We were just a tiny part of this film. Bobby and Sara spent over a year flying around the world to get this project done. they worked completely independently from us. Neither I, nor anyone in CSN, paid anyone that was interviewed or promised them compensation. We have zero financial interest in Working Pictures, nor do they have any financial interest in CSN. 

"This whole project is about educating people on the work being done to advance healthcare and we think it’s important that the word gets out."

Berman's website says he has practiced cosmetic surgery since 1983 and started his stem cell practice in 2010.  He is co-founder of Cell Surgical Network and the California Stem Cell Treatment Center. 

Erin Allday of the San Francisco Chronicle reported last year: 

"For more than three decades, Berman’s focus was breast augmentations and face-lifts. He invented a pocket-like device that can be implanted into the breast to produce better-looking, safer results from augmentation procedures. He calls it his “Sistine Chapel.”

With his business partner, Rancho Mirage (Riverside County) urologist Elliot Lander, Berman has built the largest chain of stem cell clinics in the country. Their Cell Surgical Network has more than a hundred affiliates in 33 states — including 38 clinics in California alone — selling treatments they claim will fix everything from knee pain to symptoms of multiple sclerosis.But over the past eight years, Berman has reached far past his specialty into a realm of highly sophisticated, still-nascent medicine. He’s become one of the country’s most outspoken and notorious providers of so-called consumer stem cell therapies: using human stem cells to treat a wide variety of ailments despite little or no scientific proof that they work.

“As a cosmetic surgeon, it’s kind of a joke that I’m at the center of this universe,” Berman said in an interview last fall (2017). “But I’m kind of ground zero.”

"Seven months later, his words became darkly prophetic: In May, Berman and his partner were targeted by the U.S. Food and Drug Administration. The FDA requested an injunction that, if approved by a federal judge, would stop them from selling stem cell therapies. 

"The FDA issued a similar request against a separate operation in Florida, U.S. Stem Cell Clinic.

"Their clinics, though, are just some among several hundred that have popped up across the country in recent years. They are renegade outposts operating with little legitimacy and oversight at the frontier of what is otherwise a highly promising field of medicine."

Here is a short list of other sources of information involving Berman, his treatments and  enterprises: 

• Stem cell scientist Paul Knoepfler of UC Davis has written extensively about Berman and Cell Surgical Network, going back to 2013 when Knoepfler published this Q&A.
• Vox recently carried an overview of unregulated stem cell treatments, including Berman's firm. 
• A Washington Post story about the 2018 FDA filing against Cell Surgical Network.

LA Times on Stem Cell Video Flap: 'Infomercial,' Hype and How the Hooha All Began

The Los Angeles Times this afternoon reported on the uproar over a stem cell video has left some researchers across the nation incensed and calling the film an "infomercial" that ballyhooed unproven therapies.

Twelve scientists and other experts have asked to be removed from the video that was partly financed by a California firm that is being sued federal regulators to halt the potentially dangerous treatments.

The Times piece was authored by Pulitzer Prize-winning columnist Michael Hiltzik who has written previously about the unregulated stem cell industry. He said,

"If there’s anything that drives legitimate stem cell scientists up a wall, it’s their being lumped in with clinics offering unwary customers supposedly effective disease treatments through stem cell injections."

The firm that helped fund the "Healthcare Revolution" is Cell Surgical Network, which is based in Southern California but has 100 affiliates across the country and more overseas. The Food and Drug Administration has sued the firm to halt the use of what it calls unproven and potentially dangerous treatments. 

The film was produced by Bobby and Sara Sheehan over the period of about a year. Hiltzik wrote,

“'It’s a package that’s very misleading and not balanced,' says Evan Snyder of Sanford Burnham Prebys Medical Discovery Institute. 'It was pitched like it would be a ‘Nova,’' he said, referring to the scientific series produced for the Public Broadcasting System, 'but it came out like an infomercial.' 

"Lawrence S.B. Goldstein of UC San Diego says he was led to believe the producers were making a 'balanced, sober documentary.' The trailer for the series posted on its website, however, was infused with hype—'It sounded like miracle cures from stem cells are here today—‘Give us your money and we’ll fix you up,’ giving false hope to people suffering from terrible diseases.'”

The Times piece laid out how the flap erupted just days before the video was to begin today. Hiltzik wrote,

"It was only last week that the true nature of the project emerged. That’s when Cell Surgical Network sent customers and former customers an email announcing the documentary’s upcoming premiere. The email landed in the in-box of Doris Tyler, a Florida resident who is suing Cell Surgical Network and affiliates for allegedly leaving her blind via a stem cell treatment for an eye condition.

"Tyler alerted her attorney, Andrew Yaffa, who passed the alarm on to Loring at Scripps. Loring scanned the documentary’s website and noticed that she and numerous academic colleagues were featured along with purveyors of unproven treatments. On June 13, she says, “I sent messages to everyone I knew” on the roster of participants.

"Subsequently, Sheehan disclosed that Cell Surgical Network had partially funded the series, deepening the alarm and prompting most, if not all, the academic participants to withdraw. 

“That was the kiss of death for me,” Loring told me. “I do not want to be associated with those guys at all.'”

Loring said in a letter to the Sheehans,

 "You have placed my interview among those of people who are charlatans and thieves...."

Digging into the 'Stem Cell Hard Sell:' Researcher Ventures Into 'Lion's Den'

A California stem cell researcher went "semi-undercover" recently and attended a commercial "educational seminar" that promoted stem cell treatments and handed out requests for credit information from those attending.

Paul Knoepfler -- UC Davis photo

Paul Knoepfler of UC Davis recorded his experience at the session in an article this week in the Stem Cells Translational Medicine, which was founded in 2011 with $600,000 from the California stem cell agency.

Knoepfler did not identify the stem cell clinic that conducted the session. He said he wanted instead to be able to use a "higher degree of frankness" in writing about the session. Knoepfler noted, however, that he was quickly spotted by one of the organizers, some of whom lurked around him during the session. Knoepfler wrote on his blog Monday, 

"It was an intense experience and one where I felt at risk. To some extent it is akin to  going into the lion’s den. I didn’t know what reaction I would get if I were recognized by those running the seminar, which in fact did happen. They did not seem happy at all that I was there even though I wasn’t disruptive in the least. I had hoped to ask a few questions from my place in the audience, but the format did not allow it. Still I wondered if I could be kicked out. That didn’t happen."

The clinic involved is one of at least 570 across the country. Earlier this summer, Knoepfler and Leigh Turner, a University of Minnesota bioethicist, were the first to report on the scope of what passes for the commercial stem cell clinic industry in the United States when they documented the existence of those clinics.

About 30 people attended the session Knoepfler was at, including some who obviously had "serious medical conditions." He wrote,

"The seminar team (mostly dressed in medical scrubs) handed out a clipboard to each attendee with three pieces of paper very much like those that one might be given on arriving at a new doctor's office. We were told to fill in our information and then to return the sheets back to them before we left. Notably, the top sheet was a credit application. On another page, the clinic asked for extensive personal information, including name, age, birthdate, address, e-mail and phone number. Additional questions asked about medical conditions, as well as medical tests that had already been conducted." 

Knoepfler said several medical claims were made during the meeting including that the treatments had no side effects, were safer than the normal standard of care, did not pose immune rejection problems, were federally approved and were specifically effective for arthritis and pain.

The price of the treatment was $5,999 but attendees could get $1,000 off "if you sign up today at the seminar." Attendees were told that the clinic was heavily booked already with a one to two month waiting period.

In the piece about his foray into the "lion's den," Knoepfler wrote,

“Given the growing realization that there are hundreds of stem cell clinics in the U.S. today in 2016 and the observation that many hold recruitment seminars, it is possible that thousands of members of the public each year are attending infomercial seminars that provide misleading or even outright factually incorrect information about stem cells and questionable medical claims. This could not only lead many patients to receive unnecessary, unsafe or ineffectual treatments, but it may also contribute to public confusion about stem cells and the field of stem cell clinical research. These seminars represent only one type of an assortment of recruitment methods, including Internet, radio, newspaper, and television ads for various clinics, which may also contain dubious statements. I believe that such stem cell clinic marketing poses a significant threat to public perception and understanding of the legitimate stem cell translational medicine field.”