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...."

Stem Cell Video Flap: CEO of California Stem Cell Agency Backs Out of Internet 'Docu-Series'

The president of the $3 billion California stem cell agency has removed herself from a controversial online video that placed her in the electronic company of leaders of firms targeted by federal regulators.

In an email early today to the producers of the lengthy video, Maria Millan referred to an appeal for her to reconsider her previous request to back out of the "docu-series."

"I am not swayed by the letter from Mark Berman of Cell Surgical Network and, in fact, it deepens my concern. I maintain the same position and concerns expressed in my note dated June 15. Please remove my interview from the documentary and my picture and name from any associated materials —including this link- please remove me as an “episode expert” on https://www.healthcarerev.org/?inf_contact_key=efe318f527b6ecd43046adebf597cfd9."

The video, titled the "Healthcare Revolution" was partly financed by Cell Surgical Network, which has offices in Beverly Hills and Rancho Mirage, Ca., plus about 100 affiliates nationwide. The Food and Drug Administration(FDA)has sued the firm to halt what the FDA says are unproven and potentially dangerous treatments.

A number of researchers and others pictured in the video have also asked to be removed, saying they were misled about how their interviews would be used. San Diego-area stem cell researcher Jeanne Loring declared that being in the video placed her among "charlatans and thieves" who prey on desperate patients.

Kevin McCormack, senior director of communications for the California Institute for Regenerative Medicine (CIRM), as the stem cell agency is formally known, explained what led to the agency's involvement with the video producers, Bobby and Sara Sheehan. In response to questions from the California Stem Cell Report, McCormack said, 

"When the Sheehans asked us to be part of the series we looked at previous work they had done and reviewed the questions they wanted to ask. We knew they were going to talk to a wide range of people for the series but we were sufficiently reassured that we initially agreed to the interviews feeling it was important to have our voice heard.

"However, once we learned who was partially funding the project and saw the trailer we felt it risked giving a distorted view for anyone who saw it and that it inadvertently legitimized opportunistic, bad actors. It’s unfortunate these so-called 'clinics' are trying to hijack the reputation of legitimate stem cell therapies and cash in on scientists who are doing serious, scientifically sound research....

"I think the fact that virtually all of the highly regarded scientists interviewed for the series have withdrawn from it, people like UC San Diego’s Larry Goldstein and Scripps Jeanne Loring, says everything that needs to be said. None of us who have spent years warning the public about the dangers of going to clinics offering unproven and unapproved stem cell therapies want anything to do with something that equates FDA-sanctioned clinical trials with unsanctioned and unregulated stem cell therapies."

The flap over the video comes as the number of dubious stem cell clinics is estimated to exceed 1,000 nationally, with the highest percentage in California. The state has been slow to regulate the clinics whose treatments have reportedly led to illness and blindness. Legislation aimed at the clinics is all but dead in the legislature, leaving the regulation solely in the hands of the state Medical Board. 

The board said today that it has no authority over clinics -- only physicians. The board has been mulling over the matter for about 11 months. But its two-person "task force" has yet to schedule a public meeting.  

California State Medical Board Says it Has No Authority to Regulate Dubious Medical Clinics

The California state Medical Board wants to make it clear that it does not regulate stem cell clinics -- only physicians. 

An email from its spokesman this morning said it is concerned that readers might misunderstand an item on the California Stem Cell Report last week dealing with the pace of state regulation of "snake oil" enterprises.

Carlos Villatoro said,

"I would like to request a correction/clarification in your story. The Board does NOT regulate stem cell clinics and has no authority take ANY action against stem cell clinics. "The Board’s sole jurisdiction lies in the physicians who work at the clinics, who may or may not be performing stem cell procedures.   The statement in your story,  'A spokesman for the California Medical Board, Carlos Villatoro, said this week that a task force of the board is expected to hold its first meeting this summer to deal with stem cell clinics,' is inaccurate and we are concerned that your readers will think that we regulate stem cell clinics, which we do not. "The Board would appreciate a correction/clarification. Please let me know if you have any further questions."

In a response to Villatoro, David Jensen, publisher of the California Stem Cell Report said, 

"Thank you. I will run a separate item containing your email comments. The board's position is important and significant. However, I do not think a correction is necessary. The clinics are mostly run by physicians. 'Dealing' with clinics means dealing with those who run them, i.e., physicians. I would glad to discuss this with your executive director or the chair of the board if you wish. Thanks."

Stem Cell Video Flap: World Stem Cell Summit Withdraws from 'Docu-Series'

The chairman of the World Stem Cell Summit today said that he has asked that his organization be removed from any mention in a controversial online video about stem cell therapies.

Bernard Siegel, chair of the Summit, said,

"My organization's stand on the 'Bad Actors' is clear from the numerous posting and interviews. We support the FDA in enforcement actions and condemn the actions of the purveyors of bogus treatments, false and misleading claims."

Siegel's remarks came in response to questions this morning from the California Stem Cell Report. He said that he also asked that his interview be withdrawn from the 10-part "docu-series." Some of interviews that appear in the video were done at one of the Summit conferences. 

A number of researchers and others have also asked that they be removed the video, "Healthcare Revolution," because of its ties to a California stem cell firm, Cell Surgical Network (CSN), that is the target of federal regulators. The CEO of the California stem cell agency is also listed as an interviewee in the video. 

Siegel said that the World Stem Cell Summit has no financial connection to CSN, which partially financed the video. He also said the Summit had no financial ties to Working Pictures, the firm that produced the video or its principals, Bobby and Sara Sheehan.

The Food and Drug Administration (FDA) is seeking to halt treatments provided by CSN, which has about 100 affiliates nationwide and more overseas.  CSN has offices in Beverly Hills and Rancho Mirage, Ca. (For more information on the FDA action, see here and also here.

Here is the full text of Siegel's response to the California Stem Cell Report.

"The Sheehans appeared to be, by all accounts, legitimate filmmakers with a long track record of quality productions. They did film several interviews at the World Stem Cell Summit for their documentary. The Summit team was unaware of any links the production had with Cell Surgical Network. We were surprised last week when the trailer was released and saw how the series was being framed promotionally.

"The Summit, or any other organization that I am affiliated with, certainly has no connection to the Cell Surgical Network financial or otherwise. Upon learning that CSN funded the production, I withdrew my own interview from the project and requested the removal of any reference to my organization.

"We have no financial ties to the Sheehans or their production company. I have spoken to Sara and Bobby Sheehan who instantly agreed to remove any individual who sought to remove his or her interview from the series. They have proven themselves totally cooperative to date in that regard. They appear to be caught in the middle of a war, unfortunately lacking the depth of understanding.

"My organization's stand on the 'Bad Actors' is clear from the numerous posting and interviews. We support the the FDA in enforcement actions and condemn the actions of the purveyors of bogus treatments, false and misleading claims."

Stem Cell Video Flap: California Firm Asks Concerned Scientists to Reconsider Requests for Removal

This is a clip from the web site for the video "The Healthcare Revolution."

More details emerged late today about a controversial Internet video backed by a California stem cell firm that is being sued by federal government to halt what allegedly are "unproven and potentially dangerous treatments."

The video features the CEO of the $3 billion stem cell agency, Maria Millan, and more than 80 other researchers and academics. The video website displays logos of academic institutions ranging from Stanford to the University of Cambridge. The site says the video will reveal that "stem cell technology that is said to be 10, 20, years down the road is actually here – NOW!"

Some of the researchers who appear in the video have asked to be removed because of its connection to Cell Surgical Network(CSN), which has offices in Beverly Hills and Rancho Mirage, Ca. The firm said it has funded a portion of what it called "this important docuseries." CSN today asked concerned scientists to reconsider their requests. 

CSN has been sued by the Food and Drug Administration to  halt its treatment practices.

Jeanne Loring, professor emeritus from Scripps Research, is one of those scientists whose remarks were carried in the video. In an email, she said she only learned that she was in the video last week. The recording of her came from an interview that she did at the World Stem Cell Summit. 

Loring has been a longstanding foe of unregulated stem cell clinics. She wrote the producers of the video, Sara and Bobby Sheehan:

"As I have explained many times, to print reporters, community groups, and in video interviews, as a scientist with a moral compass, I cannot condone exploitation of desperate people who are led to believe that they will be cured or even helped by a clinic or a pill or any purported therapy that is not based in science.... 

"You have placed my interview among those of people who are charlatans and thieves, and I request that you remove all reference to me in the video and on your website." 

(See here for the full text of Loring's letter.)

The firm initially granted Loring's request but then late today appealed to her to change her mind. Loring refused. 

In her email today to Loring, Sara Sheehan cited a letter sent out today to "concerned stem cell scientists and doctors" by Mark Berman, co-founder of Cell Surgical Network. It appeared to be addressed to other researchers filmed for the video. 

Berman said his firm made "no effort to control (the) production" of the video. 

Berman told the researchers,

"Personally, I think a lot of the participants who want to drop out know little and/or nothing about the work CSN has been doing worldwide. They do not know about some of the amazing basic science research we have funded, nor do they know about the hundreds of patients that we have treated at no cost and hundreds at markedly reduced rates including dozens of patients that have had multiple deployments at no cost."

(The full text of Berman's letter can be found here.)