Beyond Blastocysts: 'Simple Stories' and Stem Cell Research Funding

The California stem cell agency this week had some useful advice for telling the stem cell story, be it in Keokuk, Ia., or La Jolla, Ca. 

It is not necessarily just a matter of petri dishes and blastocysts.  It is a matter of "simple stories that illustrate what you did and who it helped or might help."

The advice came from Kevin McCormack, senior director of communications for the California stem cell agency, in an item on the agency's blog, The Stem Cellar. 

The piece grew out of a panel at the meeting this week of the International Society for Stem Cell Research in Los Angeles. McCormack began by briefly recounting the experiences of researchers who carried their pitches into legislative and Congressional arenas.

Those are places where the money is -- the lifeblood of scientific research. 

Money, incidentally, is of particular interest at California Institute for Regenerative Medicine (CIRM), as the $3 billion agency is formally known. On Monday it will shut down applications for new awards because in a few months it expects to run out of cash for them. 

Here is a little of what McCormack had to say concerning communication and scientific research, drawing from the ISSCR panel.

"(P)resenters talked about their struggles with different issues and different audiences but similar experiences; how do you communicate clearly and effectively. The answer is actually pretty simple. You talk to people in a way they understand with language they understand. Not with dense scientific jargon. Not with reams of data. Just by telling simple stories that illustrate what you did and who it helped or might help.

"The power of ISSCR is that it can bring together a roomful of brilliant scientists from all over the world who want to learn about these things, who want to be better communicators. They know that much of the money for scientific research comes from governments or state agencies, that this is public money, and that if the public is going to continue to support this research it needs to know how that money is being spent.

"That’s a message CIRM has been promoting for years. We know that communicating with the public is not an option, it’s a responsibility. That’s why, at a time when the very notion of science sometimes seems to be under attack, and the idea of public funding for that science is certainly under threat, having meetings like this that brings researchers together and gives them access to new tools is vital. The tools they can 'get' at ISSCR are ones they might never learn in the lab, but they are tools that might just mean they get the money needed to do the work they want to."

A Stem Cell Crossroads in California: The Viewpoint From USC

The University of Southern California, co-sponsor of a meeting this week in Los Angeles of 4,000 stem cell researchers and others, has offered up a perspective on its program and the crossroads facing California. 

The lengthy piece by Gary Polakovic captured more than the work being done USC, which has received $111 million in funding from the state stem cell agency, formally known as the California Institute for Regenerative Medicine (CIRM). 

He touted the program at USC but also looked at the state of stem cell affairs in the Golden State.  

Keying off the annual meeting of International Society for Stem Cell Research, Polakovic, research communications manager at USC, wrote, 

"California has proven fertile soil for stem cell research. The state has assumed a leadership role in stem cell science since voters approved Proposition 71 in 2004, which seeded the industry with $3 billion in bond funds. The program is administered by CIRM, which contributes about 30 percent of USC stem cell funding."

The article continued, 

"With progress comes growing pains, and California’s stem cell program is at a crossroads.

"On one hand, gains in the lab have moved stem cell therapies closer to making a significant impact on medicine. Yet, the complexity and cost of cellular medicine has proven a big challenge. Scientists acknowledge it will be difficult to cure major diseases with stem cells. The gap between hype and hope has narrowed, but not closed.

"'Hype can be right, but it’s the time frame when people

Andrew McMahon, USC photo 

expect things to happen that can be wrong,' (Andrew) McMahon (director of the USC stem cell program) said. 'Curing cancer, diabetes, Alzheimer’s and other diseases is taking longer and involves a lot more complication and funding. The progress has been astounding — but it’s never fast enough.'"

Polakovic also tackled the difficult financial condition of the state stem cell agency. He wrote, 

"State funding for stem cell research under CIRM is expected to run out this year. The $3 billion ballot initiative that voters approved — Proposition 71, the California Stem Cell Research and Cures Act — is substantially depleted. Other sources, such as federal funding, private investment and philanthropy, are available but not necessarily dedicated to statewide research. CIRM funds have played a big role in creating and sustaining the USC stem cell initiative.

"Researchers are hopeful California voters will have an appetite to continue funding. Backers of Proposition 71 are planning a $5 billion measure for the November 2020 ballot. With research gains and clinical trials underway, backers are hopeful California will continue to support progress for another decade.

"Yet, voter perception of stem cells could be colored by rogue clinics peddling dubious wonder cures like snake oil. Those businesses operate outside the realm of leading research institutions such as USC. More than 100 such stem cell clinics operate in California alone. The Food and Drug Administration is stepping up enforcement actions against clinics offering unapproved stem cell products that endanger the public.

"At the same time, the momentum toward stem cell therapies at USC and other universities is undeniable. On the trail to finding breakthroughs for big diseases, basic research has unlocked a host of co-benefits — many unforeseen when California embarked on its stem cell program 15 years ago — that are valuable to medicine."

California Stem Cell Agency Pitches for Support; Los Angeles Event Scheduled Tuesday

Just one day before the California stem cell agency announced it was cutting off applications for more research funding, it made an ardent pitch to the public for increased support. 

The appeal concerned a public event that the agency, formally known as the California Institute for Regenerative Medicine (CIRM), is staging on Tuesday in Los Angeles. 

In an item on the agency's blog, The Stem Cellar, Kevin McCormack, senior director of communications, briefly recounted the $3 billion agency's work. And then he wrote,

 "We still have a lot to do. The problem is we are quickly running out of money. We expect to have enough money to fund new projects up to the end of this year....Some may get funding from other sources, but many won’t. We don’t want to let that happen."

Stem researchers, CIRM leaders and others will be there. McCormack said,

"It’s going to be an opportunity to learn about the real progress being made in stem cell research, thanks in no small part to CIRM’s funding."

On the web page for the event, there was also this:

"You'll hear from a woman whose infant daughter was cured of a fatal immune-system disorder, from the doctor who developed that treatment and from stem cell champions who are worried what will happen to the most promising research if CIRM no longer exists."

 The free, public event will be in the Los Angeles Convention Center, 1201 South Figueroa St., Petree Hall C. The event begins at 6 p.m. but McCormack said CIRM staffers will be there at 5 p.m. to answer questions.

Interested persons can RSVP here. But it is unlikely that anyone will be turned away.

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.

Stem Cell Video Flap: A Look at the Firm that Produced the "Docu-Series"

Bobby Sheehan discusses his personal and professional background in this YouTube clip.

Who are Bobby and Sara Sheehan, not to mention Working Pictures? 

It is a question that arises from their controversial "docu-series" that raised a ruckus this week in the small world of stem cell science.

Their online video, "Healthcare Revolution," was an unpleasant surprise for at least 12 scientists and other experts who learned only a few days ago they were appearing in the production. All of them asked to be removed.

They believed that they had been misled about how interviews that they had given many months ago were going to be used. 

They objected to sharing an electronic platform with dubious enterprises that are current targets of the federal government's actions to shut down dangerous and unproven stem cell treatments. 

Executives of those firms also appeared in the video in a manner that was considered a case of "false equivalency."

Earllier this week, the California Stem Cell Report queried Sara Sheehan about the video and their links to a California stem cell firm, Cell Surgical Network, with 100 national affiliates that the Food and Drug Administration is suing. 

The full text of her response runs below. But first a little background drawn from the Internet.

Sara Sheehan is executive producer for Working Pictures, according to its web site.  Her husband, Bobby, is producer, director, writer and cameraman. Their web site says Bobby had a "nomadic and slightly feral" upbringing. It also said, 

Sara Sheehan
 Working Pictures photo

"Collectively, they have produced well over a hundred hours of content in the form of online and conventional TV series, documentaries, and narrative films. Bobby has directed and lensed over 300 commercials…and they have produced three talented children."

The Sheehans are also associated with another enterprise called "Mortal," which deals with death and spiritual awareness. 

The California Stem Cell Report asked Sara Sheehan about the cost of the stem cell docu-series, which was partly financed by Cell Surgical Network, and any other financial ties with that firm.  Here is the verbatim text of her reply.

"I appreciate your asking us to provide additional information and I have answered your questions below: 

"We set out to produce a documentary series about the very complex regenerative medicine landscape. There is a lot of information out there and consumers are faced with a daunting amount of opposing opinions and concerns. We felt that by showing the entire landscape - including advances in research that will be providing hope to patients years down the line, the fact that many consumers are going overseas for treatments, the legislation that has been enacted in this country, patients who have gotten treatments in this country and other countries and their outcomes, and the lawsuits- we would educate the consumers who would see this and allow them to make the best decisions for themselves and their loved ones. 

"We looked for financing for the series, which took a year to make. We had investors, Drs. Berman and Landers (of Cell Surgical Network) were part of that team. Never did they ask to see edits, to control the content or interfere with the story in any way. That was the deal. The rest of the costs we bootstrapped ourselves: our investors did not pay us for our time and we covered many costs ourselves. We are not connected in any other way to Cell Surgical Network or any other regenerative medicine provider, nor do we stand to benefit financially from any procedures or products being marketed. We have no family members connected to Cell Surgical Network or any other regenerative medicine providers. The bottom line is that we are filmmakers who attempted to outline what is clearly a heated and emotionally charged environment. Ironically, Cell Surgical Network is featured most prominently in an episode entitled The Lawsuits, outlining the cases against US Stem Cell and Cell Surgical Network. We had updated that episode to reflect the decision against US Stem Cell. 

"We never paid anyone to be interviewed. In fact I have NEVER paid anyone to be interviewed for this project or any other project.

"After a year of interviewing and editing as many and as varied voices as possible, the resulting series is 12 episodes long. We organized the information by subject and feel we had a comprehensive product that provided a good, basic overview of the field that included many opposing points of view. There is a tremendous amount of information contained in the series that we felt showed as much of the landscape as we were allowed to capture.

"Unfortunately, a number of people expressed concern about being included in the project and we immediately responded that we would honor their wishes to be removed."

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.  

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.)

Text of Loring Letter Asking to be Removed from Stem Cell Video

Here is the text of email that stem cell scientist Jeanne Loring sent to Sara Sheehan in connection with the controversial "HealthRevolution" documentary. 

​"Dear Sara:
"When I was interviewed at the World Stem Cell Summit, I was misled about the context in which my interview would be placed. I was told that it would be an educational video about the progress of legitimate stem cell therapies.

"I am a staunch and outspoken opponent of clinics that flout the FDA regulations for stem cell treatments, and have met many people who have paid many thousands of dollars to obtain unregulated (and therefore unsafe) treatments that claim that stem cells will magically cure any disease.

"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.

"I know you are young, but this is equivalent in history to the Laetrile scam of the 1970s. Thousands of desperate people emptied their wallets and obtained this alleged therapy before the FDA stepped in and banned it. Many were crushed and bankrupt; some died.

"'Stem cell' clinics are worse, because they can market their useless and dangerous products to a far larger audience.

"FDA leaders Scott Gottlieb and Peter Marks have denounced these unregulated clinics as “bad actors”, and I would go further - I think they are criminals.

"I use pluripotent stem cells to generate real cell types to replace cells that have died in disease. I have not seen any evidence that extracts from fat, or bone marrow, or products derived from placentas and umbilical cords have any medical value.

"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.

"I understand that you are good and honest film makers, so this should not be a difficult request. Please respond that you have removed me and I will not trouble you further."

"Sincerely,
"Jeanne Loring"

Stem Cell Researchers Backing Away from Documentary Touting 'Greatest Paradigm Shift in Medical History'

What do Maria Millan, CEO of the $3 billion California stem cell agency, Larry Goldstein of UC San Diego, Thomas Murphy of Harvard/MIT  and Mark Berman of Cell Surgical Network have in common this morning?

They are all loosely listed as "trusted sources" on a website ballyhooing a 10-part documentary involving stem cells. All are identified as taking part in the documentary. Berman's firm, however, is a target of the Food and Drug Administration, which is seeking to halt the enterprise's "unproven and potentially dangerous treatments." 

Erin Allday of the San Francisco Chronicle reported on the connections in a story this weekend that said some of the scientists involved in the documentary, scheduled to be released tomorrow, want out of the online video because it is partly funded by Berman's firm. 

The documentary is titled "The Healthcare Revolution." The Internet address of Berman's firm is stemcellrevolution.com."  It also offers a book called "The Stem Cell Revolution." The business has offices in Beverly Hills and Rancho Mirage, Ca., and is linked to reportedly dozens of similar enterprises.

Allday quoted Berman as saying in an email to patients last week,

“We have a wonderful docuseries coming out. It’s a whole production, not just about us. It’s going to enlighten people."

The website of the documentary features ebullient language about stem cells. "Stem cell technology that is said to be 10, 20 years down the road is actually here --  NOW!" reads one sentence on the video site.  The largest headline on the site said in bold red type, 

"This Must See Documentary Series Unveils the Greatest 
Paradigm Shift in Medical History"

Allday's story said some of the scientists involved in the documentary now say "they weren’t aware of who was backing the project when they agreed to participate...Some scientists said they fear the documentary may promote what they consider junk science."

Allday continued, 

"In fact, many of the scientists listed on the website have said repeatedly that stem cell therapies are still years away from being ready for patients. They have said that the hundreds of providers treating patients at for-profit clinics are selling 'snake oil' products that are worthless and potentially unsafe. No stem cell therapy currently sold at for-profit clinics has been approved by the FDA."

The Chronicle article said the California stem cell agency did not know who was financing the documentary when it agreed to participate.  A spokesman for the agency, known formally as the California Institute for Regenerative Medicine, told Allday that the agency agreed to participate because it would provide an opportunity to promote its work and warn against dubious clinics. 

One scientist who was scheduled to appear in the documentary is Jeanne Loring, professor emeritus at Scripps Research in La Jolla. She told Allday, “I am a stalwart and outspoken critic of unapproved stem cell therapies. I don’t belong in their company."

She said the producers of the video agreed to remove her from the documentary. 

More than 80 physicians and scientists are listed as "trusted sources" or experts on the video website along with a number of major academic institutions, including Stanford, Harvard, John Hopkins, Yale and Oxford.  Also listed is Kristin Comella, chief scientific officer of U.S. Stem Cells, Inc., which earlier this month lost a key ruling in lawsuit filed by the FDA against it. 

California's Stem Cell Agency Smacks Stanford for Failing to Deliver on Financial Promises

The California stem cell agency today delivered an unusual and sharp rebuke to Stanford University, declaring that it needs to stand by its financial commitments to help back state-funded research. 

The message came during consideration of a request for more research cash from a Stanford researcher, Judith Shizuru. She sought $6 million for continuation of a clinical trial to develop a potentially "transformative" product that would eliminate the toxic impact of chemotherapy for a number of diseases. 

"It boggles my mind," said Jeff Sheehy, a member of the agency's governing board and chairman of its Science Committee, that Stanford, which has an endowment of $27 billion, has not stepped forward to provide the co-funding. 

The amount involved is $1.7 million and is due May 1. It is connected to an earlier $19 million award to Shizuru that kicked off her clinical trial. 

Sheehy noted that Stanford and its researchers have received $379 million from the agency since 2005. It is the top recipient of funds from the California Institute for Regenerative Medicine (CIRM), as the agency is formally known. Stanford also has a member on CIRM's board. 

Steve Juelsgaard, chairman of the board's Finance Committee and a former top executive at Genentech, said that Stanford is "very well taken care of in terms of its economics." 

He said that the agency requires all institutions and businesses to sign agreements to deliver on promises of co-funding. CIRM cannot have two standards for its grantees, Juelsgaard said. 

Today was the first time that the $3 billion research agency has publicly rebuked a grantee on co-funding. Recipients of awards, be they institutions or individual researchers, are generally  treated tenderly in public.  (The full transcript of the meeting is available here.)

CIRM directors did not take issue with the quality of the research, which they described as good. Specifically, today's application sought to advance Shizuru's phase one clinical trial to develop a way to avoid the necessity of chemotherapy in a genetic affliction, popularly known as the bubble baby syndrome.

Nine researchers in the field sent letters to the CIRM board praising the work. Several called it "transformative" and said it could have use in afflictions ranging from blood cancer to diabetes. 

Shizuru applied for $6 million. However, the CIRM board reduced the award to $3.7 million and only on the condition that the previous co-funding be delivered.  

Shizuru told the CIRM board she accepted responsibility for raising the co-funding, which she said has been difficult. Board members noted that agreements on awards are signed by both the recipient researcher and his/her insitution. She said she would discuss today's action with Stanford officials.

Her application came before directors in January with a seal of approval from the agency's reviewers, who make their decisions behind closed doors. Normally, approval by reviewers means a rubber stamp by directors.

Action in January, however, was deferred until this month after directors raised questions about research delays and financial matters. The agency also publicly released a slough of information concerning Shizuru's work, most of which she provided to them.  

Here are links to key documents involving Shizuru application. 

• CIRM's news release on today's action
• CIRM's summary of reviewer comments on Shizuru's application, CLIN2-11431. The agency does not disclose the full application.
• CIRM staff's presentation today concerning the application
• Transcript of the January directors' meeting, including a relatively lengthy discussion and comments by Shizuru
• Today's meeting agenda, which includes links to the letters of support, most of them from prominent researchers in the field
• CIRM award details on the $19 million award, including three progress reports 
• Shizuru successful appeal letter on her 2012 application, which had a median score of 50 and was rejected by reviewers. 
• Clinicaltrials.gov information on Shizuru's clinical trial (start date and last update, both Nov. 15, 2016

(An early version of this item misspelled Shizuru's last name.)

A Stem Cell Media Story: The Case of the Missing Mention

Storks and stem cell blessings

California's $3 billion stem cell agency, which is fighting to demonstrate its value proposition, this week received what could be considered some favorable attention in the prestigious journal Nature.

The catch is that the 14-year-old research program was not mentioned by name by Nature.

The question is: How does that work and why it is important?

First things first: It is important because the agency, known formally as the California Institute for Regenerative Medicine (CIRM), is hoping that the voters will bless it with another $5 billion come the November 2020 election.

The agency expects to run out of money for new awards this year and is also trying to raise privately more than $200 million to tide it over until the 2020 election. In both cases, it needs clear successes that demonstrate that it has earned its keep and will do even better in the future. 

Unproven Therapies in Japan

The not-so-odd case from Nature involves an editorial that cited a CIRM-funded clinical trial.  Nature praised it as something to be emulated in Japan as an example of good ethics and good science. 

Nature's editorial zeroed in on how Japan has embarked on "a worrisome approach." The headlines said,  "Japan should put the brakes on stem cell sales. Unproven therapies should not be marketed to patients."

Instead, Nature declared that Japan should focus on the approach taken by Asterias Biotherapeutics, Inc., of Menlo Park, Ca., which arguably owes its existence largely to CIRM. (See here, here and here.)  Nature wrote, 

"Last week, a Californian company called Asterias Biotherapeutics released promising results from a 12-month first phase clinical trial, in which embryonic stem cells are converted into oligodendrocytes — cells of the central nervous system that support neurons and can stimulate their growth — and then injected into the backs of people with a spinal-cord injury. The data show that injected cells do stick around at the injury site, and that most patients (21 out of 22) showed improved movement. 

"But these are still early-stage results. It is not clear yet whether the improvements are the result of the cells, or whether something else, such as the body’s own regenerative capacity, was at work. To find out, the company wants permission to move forward with a randomized, controlled phase II clinical trial. That’s the right way to do things: stepping carefully, slowly and rigorously forward."

It's Not the Stork

The problem for the stem cell agency, of course, is that Nature did not identify CIRM as a player in the Asterias effort, although the agency has pumped more than $20 million into the research. The case of the missing mention is not an unfamiliar situation for the agency, which is often not noticed in news and press releases about the scientific accomplishments that it has backed with tens of millions of dollars. 

Of course, CIRM cannot take full credit for the Asterias work. And federal regulators have rules for clinical trials. But CIRM put up the cash for the research after Asterias' predecessor bailed out.  The agency also partners closely with its grantees and has a clear set of pioneering research standards that it worked out more than a decade ago. 

Obviously, CIRM would have been only a brief note, perhaps only a phrase in the Nature editorial if it had decided to include a mention. But these things add up and are needed by CIRM as it tries to tell California voters that it has been worth $3 billion. Their absence can amount ultimately to a substantial negative. 

One does not have to support more cash for CIRM to recognize that California voters need the full array of information about the agency to make an informed decision in 2020. Currently, however, the traditions and practices of scientific journalism regularly omit significant financial information.

When one reads about scientific advances in the mainstream media as well as journals, it seems as if the research magically materializes without a critical insemination of cash -- much like a baby being brought by the stork.

Perhaps it is time for CIRM, other research funding agencies and patient advocates to have a facts-of-life "talk" with the scientific press about the reality of what it takes to give birth to prodigious medical advances.

(Editor's note: Here is a related item by UC Davis stem cell research Paul Knoepfler on the Japanese program.)

The Golden State's Stem Cell Agency Sells its 'Powerful' Story: 2,700 Discoveries, 50 Clinical Trials, Billions Awarded

Ronnie's California stem cell story

"Something Better Than Hope" -- That's the new anthem of California's $3 billion stem cell research program, which is scheduled this year to run out money for new awards.

The 14-year-old stem cell agency trumpeted its new slogan this morning when it released its annual report for 2018. It's a "powerful story," the agency declared on its blog. 

The 28-page document chronicled the state of affairs at the California Institute of Regenerative Medicine (CIRM), as the agency is formally known. The report is titled "Something Better Than Hope. Right Now." CIRM said, 

"While once there was only hope, now we know that cures are imminent."

Kevin McCormack, senior director of communications, celebrated the agency's annual review on its blog, The Stem Cellar. He wrote,

• "50 clinical trials funded to date, 7 this year alone
• "$2.6 billion in CIRM grants has been leveraged to bring in an additional

• "$3.2 billion in matching funds and investments from other sources.

• "1,180 patients have been involved in CIRM clinical trials"

The report itself said,

"CIRM has funded 1,000 projects at more than 70 institutions in California and is the largest single funder in the world of clinical research for stem cell and regenerative medicine. More than 2,700 medical discoveries have been peer reviewed and published in scientific journals. But, most importantly, lives have been saved, second chances have become possible and cures have risen beyond hope."

Stories of the lives of patients in clinical trials were not neglected, including Ronnie, the toddler in the video at the top of this item.

Maria Millan, the CIRM CEO who was a pediatric surgeon earlier in her career, wrote,

"CIRM’s mission is to accelerate stem cell treatments to patients with unmet medical needs.  

"Think about patients like baby Elianna on page 2. She was treated with stem cells for a life-threatening blood disorder while still in her mother’s womb. Ronnie (page 15), who was born with what was previously considered a fatal immune disorder, is alive and thriving today. These stories inspire and motivate us to continue to build upon the great strides CIRM has already made "

The annual report is expected to serve as an important tool as the agency attempts to raise privately more than $200 million to back its efforts until the fall of 2020. That is when CIRM is hoping that California voters will approve $5 billion more for the agency so it can continue its work. 

Annual reports from businesses and government agencies are predictably tilted towards the most positive view of their performance. CIRM's report is no exception. Nonetheless, the agency has run up a record of accomplishment that is significant and important. However, it has not yet fulfilled the expectations of voters in 2004 who were led to believe that nearly miraculous stem cell cures were right around the corner.

Don Reed is a patient advocate who has not lost faith in the promise of stem cells. The California stem cell agency is also indebted to him for his ability to turn the phrase that adorned the cover of the annual report. He was quoted in the report as saying:

"Today, thanks to the 7.2 million voters who authorized the California Institute for Regenerative Medicine, or CIRM, we have something better than hope; we have results, accomplishments, people made well— and a systematic way to fight chronic disease."

Top Ten Blog Hits by the $3 Billion California Stem Cell Agency

The California stem cell agency produces a blog called "The Stem Cellar," which regularly features fine pieces on stem cell matters in general as well as articles about its own activities.

This week the agency produced a list of the most popular postings on its site. Here is the rundown on the top 10.

• "New stem cell treatment for ALS may slow disease progression
• "Can stem cell therapies help ALS patients
• "Stem cell study holds out promise for kidney disease
• "Your guide to awesome stem cell conferences in 2018
• "Young man with spinal cord injury regains use of hands and arms after stem cell therapy
• "jCyte shares encouraging news update about clinical trial for Retinitis Pigmentosa
• "Stem cell patch restores vision in patients with age-related macular degeneration
• "The 10 most popular stem cell stories of 2017 (is that cheating to include a story about the most popular stories of 2017 in a blog about the most popular blogs of 2018?)
• "Could stem cells help beat multiple sclerosis
• "One-time lasting treatment for Sickle Cell Disease may be on the horizon according to new CIRM-funded study"

Walking a Thin Line at the California Stem Cell Agency

California's stem cell agency has a delicate dance to perform as it edges closer to seeing a $5 billion measure on the ballot to provide more funding for its efforts.

The dance involves a prohibition on state agencies spending public money on behalf of bond measures. The $3 billion agency has a legitimate responsibility to keep the public informed about its activities, but when does that task step over a legal line? 

CALmatters, an online news site devoted to state government matters, touched on the issue this morning. Dan Morain, the site's senior editor, wrote about a couple of cases in the last election.

In his morning newsletter "What Matters," he cited a tiny fine imposed on the Bay Area Rapid Transit District and another case involving an $800,000 expenditure by Los Angeles County board of supervisors, which is unresolved.

As for the stem cell agency, it is certain to be accused of using public money to support any ballot measure that may emerge in 2020. 

That would be part of the political tactics of opponents to the measure -- a portrayal of the stem cell agency as unworthy of voter trust.

The agency is treading lightly in this area right now, a position that will serve it well as more clarity emerges on whether a ballot initiative will actually surface on the November 2020 ballot. 

The Valley of Death and the California Stem Cell Agency: Luring Deep Pocket Investors

The California stem cell agency this week is tooting a $150 million horn and heralding its efforts to assist stem cell businesses with development of therapies that could ease the travails of everything from cancer to blindness.

It is all about a financial "valley of death" that can imperil biotech firms as they seek to turn research into an actual product that can be used by patients. The latest poster child for the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, is a San Diego firm called ViaCyte. 

The enterprise has received more cash -- $72 million -- from CIRM than any other business. CIRM is facing its own valley of death next year, when its taxpayer cash will run out.

Writing yesterday on the CIRM blog, the agency's communications director, Kevin McCormack, said,

"CIRM was created, in part, to help...great ideas get through the valley (of death). That’s why it is so gratifying to hear the news today from ViaCyte – that is developing a promising approach to treating type 1 diabetes – that they have secured $80 million in additional financing.

"The money comes from Bain Capital Life Sciences, TPG and RA Capital Management and several other investors. It’s important because it is a kind of vote of confidence in ViaCyte, suggesting these deep-pocket investors believe the company’s approach has real potential."

McCormack continued,

"CIRM has been a big supporter of ViaCyte for several years, investing more than $70 million to help them develop a cell therapy that can be implanted under the skin that is capable of delivering insulin to people with type 1 diabetes when needed. The fact that these investors are now stepping up to help it progress suggests we are not alone in thinking this project has tremendous promise.

"But ViaCyte is far from the only company that has benefitted from CIRM’s early and consistent support. This year alone CIRM-funded companies have raised more than $1.0 billion in funding from outside investors; a clear sign of validation not just for the companies and their therapies, but also for CIRM and its judgment.

"This includes:

• Humacyte raising $225 million for its program to help people battling kidney failure
• Forty Seven Inc. raising $113 million from an Initial Public Offering for its programs targeting different forms of cancer
• Nohla Therapeutics raising $56 million for its program treating acute myeloid leukemia"

One could argue that these companies could have found backing from other sources than the stem cell agency. One could argue that state government should not be in a business that is too risky for even the vaunted world of venture capitalists.

Nonetheless it is an important part of the CIRM story, one that will be tested perhaps in November 2020. That's when the $3 billion agency hopes to see a measure on the ballot that will give it another $5 billion. So far the agency, created in 2004 by a ballot initiative, has not fulfilled voter expectations that it would produce a stem cell therapy that is widely available. And it will need a good yarn to inspire voters once again in 2020.