California's Quest for Stem Cell Therapies: $5.5 Billion Reboot Kicked Off Today

California's ambitious stem cell agency today launched itself on a new, $5.5 billion journey, approving a plan to hand out $182 million to researchers by the middle of next year and beefing up its efforts to bring equality to therapies and scientific labs.

The moves came courtesy of Proposition 14, the ballot initiative that saved the financial life of the California Institute for Regenerative Medicine (CIRM), as the agency is officially known.  Just 12 months ago, CIRM was dealing with its possible demise as it was running out of the $3 billion that voters gave it in 2004. 

Proposition 14 sets the agency, which currently has only 33 employees, on a sweeping course that extends its work into areas such as mental health and "aging as a pathology." The agency's new, 17,000-word charter also provides up to $155 million for work dealing with affordability and access to possible stem cell therapies. 

CIRM was created 16 years ago by another ballot initiative following a campaign that raised voter expectations that stem cell therapies were right around the corner. The agency has yet to help finance a stem cell therapy that is approved for widespread use by the federal government, although CIRM is backing 68 clinical trials, a number that was considered unimaginable in 2004, the year the agency was born. 

During its online meeting today, the agency's governing board approved, as expected, a $182 million plan to make 36 awards during the next six months. It calls for $100 million for clinical work, $22 million for basic research and $60 million for translational research, which involves attempts to move discoveries into the clinical stage, the last stop before they are approved for general distribution. 

A call for applications is expected to be posted soon. 

The board took its first step to address the affordability and access issues identified by Proposition 14. Eight persons were named to CIRM's new Affordability and Access committee. It will be led by CIRM's vice chair, Art Torres, a former state legislator and who also serves on the board of Covered California, a state body designed to deal with affordability issues in connection with the federal Affordable Care Act. More persons are expected to be named to the affordability committee next month. 

The CIRM board approved changes in how it evaluates applications for awards to require scientists to specifically address diversity and equity issues. Under its new rules, applications will be scored on how well the research deals with underserved communities. Applicants will also be scored on the diversity of their research teams. 

The agency's new operational budget calls for the hiring of 10 more employees between now and the end of June, ranging from a vice president for science to an administrative assistant. Job listings are expected to be posted soon. 

CIRM Chairman Jonathan Thomas laid out some details for crafting a new strategic plan for the next five years. It includes action on the plan by the end of June, which will mean that requests for applications will be issued soon thereafter.  The June date has been moved up from later in the summer.

The public and researchers will be able to weigh in with comments and suggestions during the development of the plan. 

Today's session stood in sharp contrast to the agency's first meeting this month in 2004, just after the voter approval of the ballot measure that created CIRM.  The fledgling agency did not have a single employee. It had no bank account, no offices and no phones. Spectators, interested parties and news reporters, nonetheless, crowded into the CIRM board's first meeting. Major stories appeared in the media throughout the state. 

Today, CIRM's online session was watched by only about 30 to 40 persons, most of whom were likely associated with the agency itself. And the meeting drew virtually no media attention.

No. 1 Read: A 'Deep Dive' Into the Sweeping Changes Made in California's $12 Billion Stem Cell Program

Capitol Weekly's Twitter item on its most
read story of 2020

Capitol Weekly, the respected online news service devoted to state government and politics, this week reported that its most-read story of the year is an article headlined "Proposition 14: There’s much, much more than meets the eye."

The piece was written by yours truly and dealt with the successful ballot initiative that saved the state stem cell agency from financial oblivion with a $5.5 billion infusion of borrowed money. 

The 17,000-word measure, however, also involved a sweeping expansion of the scope of the agency and made a host of consequential changes. The freelance piece began: 

"Proposition 14, the fall ballot measure to save California’s stem cell agency from financial extinction, contains much, much more than the $5.5 billion that it is seeking from the state’s voters.

"Added to the agency’s charter would be research involving mental health, 'therapy delivery,' personalized medicine and 'aging as a pathology.' That is not to mention a greater emphasis on supporting 'vital research opportunities' that are not stem cell-related.

"The measure would enlarge the board from 29 to 35 members. Even at 29, the board has been much criticized for its large size, which creates more possibilities for conflicts of interest, a long-standing issue for the agency.

"Proposition 14 would ban royalties generated by state-backed stem cell inventions from being used for such things as prisons and schools, isolating the funds from tinkering by lawmakers."

The Aug. 31 article was drawn from my new book, "California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures."  The book is a product of 15 years of coverage of the stem cell agency and posting of more than 5,000 items on its activities on the California Stem Cell Report.

Other stories in Capitol Weekly's top ten, most-read articles include the governor's plans for a stricter Covid lockdown, the tough sell facing California ballot measures and Capitol Weekly's list of the state's 100, top unelected political power players.

Capitol Weekly has been around for decades, originally as a print publication. It is now part of Open California, a nonprofit that helps to fill a gap left by diminishing coverage of state issues by the mainstream media. 

On its website, Open California says, 

"Our mission is to inform, enlighten and educate Californians about public policy and state governance, and to provide a platform for engagement with public officials, advocates and political interests.  To meet this goal, Open California publishes continuing, in-depth, nonpartisan coverage of current policy and political issues, and hosts regular forums for public discussion of policy and California politics."

Save the Goose: California's Stem Cell Story and the 'Army of 900'

Is the stork bringing stem cell billions?

More post-election coverage is trickling out regarding the activities of the $12 billion California stem cell agency, including a lengthy and compelling piece in the Los Angeles Times, the state's largest circulation newspaper. 

The hitch is that the Times piece does not mention the stem cell agency until the 21st paragraph, a fact that carries more weight than the 40 words in the paragraph itself. 

The article in the Times, written by columnist Sandy Banks, was not really about CIRM per se. But it was a story that might not have been told without a $13 million check from CIRM. 

The piece dealt with sickle cell disease. Banks' entry point was a patient named Evie Junior, whose harrowing experiences are certain to resonate with nearly all the paper's readers. 

Banks wrote,

"As a child, (Junior) grew accustomed to frequent hospital stays. But the disease got progressively worse as he moved through his teens; the bone pain was so disabling, he often had to be sedated with heavy-duty opioids."

Banks continued,

"At one point, the bones in both his legs were so damaged by the disease, doctors thought he might not ever walk normally again. Junior battled back."

Banks wrote,

“'I want to be cured of this disease,' he said. 'And I wish the world was more understanding about the people who are struggling with it.'”

Junior is a patient in a UCLA clinical trial led by Donald Kohn, whose research has been supported by a total of $52 million from the stem cell agency -- a figure not noted in the story. 

The stem cell agency comes into the story ever so briefly at paragraph 21. "The trial is funded by the California Institute for Regenerative Medicine (CIRM), the stem cell agency created by voters in 2004 and infused with $5.5 billion in new research money by voters who narrowly approved Proposition 14 this fall," the Times reported.

That is the first and last mention of California's stem cell program in the Times' story. However, that is better treatment of CIRM than is found in most stories in the media over the last few years -- the ones that deal with accomplishments tied to the agency's cash. (See here and also here.) The articles rarely mention where the money comes from. It could be flown in by stork, for all the readers know. 

Why is this important? The answer has to do with CIRM's reliance on tenuous, ballot-box financing and the sustainability of the California stem cell program.  The situation should be of interest to a little known state entity, which is the only state panel that has a legal charge to review the stem cell program.  

The panel is the Citizens Financial Accountability and Oversight Committee (CFAOC). It was created by the same ballot initiative that established the stem cell agency 16 years ago. Last month, at the CFAOC's once-a-year meeting, its members urged the agency to make itself better known. 

Proposition 14 saved the agency from financial extinction. But the measure was a squeaker, and it set the stage for another life-or-death ballot initiative. The money from Proposition 14 runs out in about 11 years. No other source of funding is provided. If CIRM goes to the ballot again in less than a decade or so, it will need a strong base of support from California voters, 8.2 million of whom voted last month to cut off funding for CIRM.

Building a solid base takes years. It also requires something of a change involving the scientific community and science journalism, which is a big ask. The tradition in scientific journals regarding funding is to relegate mention of the sources of money to a tiny footnote as if it were not the lifeblood of research.

Science writers -- the few that now exist in the mainstream media -- follow that ancient and tired public tradition of ignoring what makes research happen. They focus on "exciting" results from the bench and clinic -- not the "filthy lucre" that pays scientists, their institutions, the post-docs who labor behind the microscopes, the equipment suppliers and keeps the lights on.

Recipient institutions write the news releases -- the starting point for most journalists -- without mentioning the many, many billions that taxpayers (state and federal) have provided. Even the stem cell agency itself does not mention dollar amounts in its blog items dealing with significant results from CIRM research. (For an example, see this item from the agency's blog on the UCLA/Kohn sickle cell trial, which CIRM is funding with $13.1 million. That figure is not directly revealed in the blog item.)

Like most state agencies, CIRM is ignored by the media with only occasional exceptions. Its activities are not well known. That is not likely to change over the next decade despite the best efforts of CIRM's tiny staff. The exception would be a major or even minor scandal or development of a major breakthrough that would resonate with the people of California.

The folks in the media have a vast array of topics to cover, all of which CIRM competes with for attention. The news industry is, in fact, overwhelmed by matters that need public scrutiny: schooling for children, jobs for parents, affordability for housing, vaccines for Covid-19, homelessness, climate change, wildfires and much, much more. Meanwhile, the industry is struggling with its own sustainability issues, laying off thousands of reporters, closing outlets and desperately searching for new business models.

Breaking through this wall of issues to generate favorable, regular coverage of the stem cell agency's good works is a herculean task. And so far, the reality is that CIRM's good works are quite minor in terms of how they affect the lives of the vast majority of the people in California. 

The CIRM team, from top to bottom, has provided a prodigious amount of positive information that can resonate with the public. Building positive relationships with voters, however, is a long-term task that requires commitments that go well beyond CIRM's stalwart staffers, who currently weigh in at only 33 for a multibillion dollar program. 

CIRM has major budget and legal limitations, courtesy of Proposition 14. Its outreach team is small, again an outgrowth of ballot initiatives. Nonetheless, CIRM has a potential army of more than 900 available plus more in the future, given the agency's expansive, new responsibilities authorized by Proposition 14. And that doesn't count the patient advocates or their allied organizations.

The army of 900 consists of the researchers and institutions that have received cash from CIRM -- all potential missionaries who can carry the CIRM message from Yreka in the north to Calexico in the south. 

The institutions could highlight CIRM funding in their news releases, instead of burying or omitting it. Researchers could reach out regularly to the various affected communities to help keep the cash flowing. Grantees could pony up $2,000 each and send it off to a new, broad-based nonprofit that might be called something like "Friends of CIRM."

But more immediately, the army of 900 could -- one by one -- resolve to make six new contacts in 2021 with the public or media to tell the CIRM story. Doing so would serve science and CIRM not to mention themselves.

The next statewide election best suited for approval of another bond measure is fast approaching. It is only eight years away. That is much less time than it takes to complete the preclinical work and clinical trials needed for a federally approved stem cell treatment, which is, ultimately, the only thing that voters really want. 

If the army of 900 needs an inspirational motto, it could be something like "Save The Goose."  You know, the one that lays the Golden Eggs. It is better than relying on the stork. 

Prop. 14: California Voters Like Bond Measures Most of the Time -- At Least in the Past

If the past is any guide, the $5.5 billion ballot measure to rescue the state of California's stem cell program from financial extinction is likely to win approval today from voters.

Golden State voters have been generous with bond measures since 1986, approving them more than a majority of the time in statewide elections. 

According to figures compiled by the state's Legislative Analyst, 67 bond measures on statewide ballots have been approved in the last 34 years. Twenty-seven were rejected. 

That said, considerable caveats abound. These are not ordinary times.  

The state is reeling from wildfires, severe economic disruption, Covid-19, overstretched local and state budgets not to mention pandemic fatigue. 

And just how all that will translate to action on Proposition 14, the stem cell ballot initiative is unclear. No polls have been published on the measure, which has been eclipsed by much higher profile measures, not to mention the presidential race. 

But it could well be that the public wants more certainty in terms of medical care and cures, which the backers of Proposition 14 promise.

"Proposition 14 continues vital funding to find treatments and cures for life-threatening diseases and conditions that affect someone in nearly half of all California families – such as cancer, Alzheimer’s, and diabetes," says the campaign website.

"Stem cell research is restoring health and improving lives in California," the site says.

Oddly enough the heavy promotion in past years of snake-oil "stem cell" therapies may well benefit the measure. Everybody loves miracles. And significant segments of the public do not distinguish between legitimate and illegitimate medical claims.

That said, it could cut the other way as well, with some voters thinking Proposition 14 is a close cousin of the rogue "stem cell" clinics, which number in the hundreds across California and are almost totally unregulated. 

Election results are likely to be slow to surface this evening after polls close at 8 p.m. PDT. The mainstream media will be focused on other races that will go unmentioned here. The California Stem Cell Report, however, will be digging into the returns most of the evening and will bring Proposition 14 results to you right here on this site both tonight and again tomorrow morning. 

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​Read all about California's stem cell agency, including Proposition 14, in David Jensen's new book. Buy it on Amazon: California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures. Click here for more information on the author.

Prop. 14: USA Today Looks at UCLA Gene Therapy and California's Stem Cell Program

The Lagenhop family in Los Angeles for a clinical
trial to treat their children for a fatal affliction
Harrison Hill/USA Today photo

USA Today has published a lengthy piece involving initial, favorable results from a more than $12 million clinical trial backed by the California stem cell agency and involving a rare disease that usually ends the lives of children before they reach kindergarten age.

The article comes on the eve of the final day for voting on a ballot initiative, Proposition 14, to save the agency from financial extinction by giving it $5.5 billion more. Officially known as the California Institute for Regenerative Medicince (CIRM), the 16-year-old agency is running out of its original $3 billion and is scheduled to begin closing its doors this winter without a boost from the initiative.

The research involves three children from Ohio who are being treated at UCLA in a trial being conducted by Donald Kohn, who has performed other genetic therapy procedures for rare diseases. For the work, CIRM awarded Rocket Pharmaceuticals, Inc., a publicly traded, New York-based firm, $6.6 million in May 2019. The firm provided co-funding of $5.6 million. (Here is a link to the summary of the review of the application, CLIN2-11480.)

Over the years, CIRM has supported Kohn's work with $52 million, not including the Rocket funding. 

The USA Today article by Karen Weintraub began with the case of the family of Alicia and Jon Langenhop of Canton, Ohio. The piece delved into the history of the California stem cell program, but did not mention the agency or its official name.  Proposition 14 was mentioned twice, once in the headline. 

USA Today is a national newspaper. Circulation figures for California are not available, although it reports national, weekly circulation of 726,906. Today's story, which would resonate with many voters, was tucked away in its health section.  

The affliction involved is Leukocyte Adhesion Deficiency-I (LAD-I. 

"Patients with severe LAD-I can develop life-threatening infections because their white blood cells are unable to leave the bloodstream to fight them. Without a successful bone marrow transplant, severe LAD-I is most frequently fatal during the first 2 years of life," the Rocket web site said.

The company's stock price today closed at $28.74, up 70 cents. Its 52-week high is $30.43, and its 52-week low is $9.01. 

USA Today quoted some researchers as saying taxpayer spending has put the Golden State in "the forefront of global stem cell research." The article said, 

"George Daley, a stem cell biologist who is dean of Harvard Medical School, said he's envious of the California researchers who have access to this pot of money.

"'California has always been a very exciting place to pursue science, but prior to (the taxpayer funding), it wasn't exactly the place that was the first on the tip of your tongue as a powerhouse community for stem cell science,' he said. 'But there's no way that today it wouldn't be listed in the top three.'"

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Read all about California's stem cell agency, including Proposition 14,  in David Jensen's new book. Download it from Amazon:  California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures. Click here for more information on the author.

Prop. 14 in the Media: Supporters Plugging Away with Opinion Pieces

The ballot measure to rescue the California stem cell agency with $5.5 billion drew a few more opinion articles of support online this weekend as the opposition to Proposition 14 continued to be all but invisible. 

Supporters, however, are not likely to rest easy during the next two days. As the sponsor of the measure, Palo Alto real estate developer Robert Klein, has remarked, the impact of Covid-19 on voters, with all its economic and emotional ramifications, is the biggest question mark involving approval of Proposition 14.

The campaign has attracted little news coverage in the media with the exception of one-off pieces. No polls have been taken on the proposal, which would send the state stem cell agency into new areas that go well beyond the direction of the agency since 2004, when it was created. The agency was provided with $3 billion at the time but is scheduled to begin closing its doors this winter as the funds run out.

Here is a rundown on articles by supporters that have appeared in recent days.

Don Reed, a patient advocate and longtime supporter of the agency, continued with a parade of items on his blog, Stem Cell Battles. The most recent focused on hearing loss work at Stanford by Alan Cheng, who has received $4.5 million from the stem cell agency, officially known as the California Institute for Regenerative Medicine (CIRM).

Reed quoted Cheng as saying, 

“We see regrowth of hair cells in the mouse balance organs — and the balance function appears to improve, according to how many hair cells come back.” 

Writing on online on IVN was Alysia Vaccaro, who said, 

"In 2012, when my daughter Evangelina, “Evie,” was just six weeks old, she was diagnosed with severe combined immunodeficiency (SCID). More commonly known as “bubble baby” disease, the rare genetic disorder left her at risk of death from any infection, even a diaper rash or the common cold. Born alongside a healthy twin, we were told Evie would likely not make it to her second birthday.

"However, thanks to Proposition 71 in 2004, California voter’s initial investment in stem cell research and the California Institute for Regenerative Medicine, a groundbreaking treatment was discovered at the University of California Los Angeles that saved my daughter’s life and 49 other babies born with the same rare disease – giving them all functioning immune systems and a second chance to live a long, healthy life."

Larry Goldstein, a UC San Diego researcher who has received $21.5 million from CIRM, wrote on the Times of San Diego, 

"A yes vote on Proposition 14 is crucial to continue the pace of medical research and our state’s journey to save lives. For millions of Californians who live with a chronic disease or condition, and who need new therapies, this may be their last hope.....There is a glaring funding gap between early lab work and late-stage clinical trials — known as “The Valley of Death” — that often ends promising stem cell research."

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​Read all about California's stem cell agency, including Proposition 14,  in David Jensen's new book. Download it from Amazon:  California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures. Click here for more information on the author. 

Prop. 14 News Coverage: Los Angeles Times and Politico Take a Crack at the Stem Cell Measure

A $5.5 billion ballot measure to save the California stem cell agency from financial extinction popped up in coverage this week in the Los Angeles Times and Politico, a national political and government news service. 

Both pieces raised questions about the agency and its history, not to mention whether it fits with California's current government priorities.

The proposal is Proposition 14. It would provide the billions to the agency,  expanding its scope significantly into such areas as mental health and therapy delivery that are not necessarily related to stem cells. 

In his piece, George Skelton, a longtime political columnist for the Times, the largest circulation newspaper in the state, noted that the agency was funded in 2004 with $3 billion, which is now running out. Skelton wrote, 

"That’s a ton of money for a little-noticed agency that provides a questionable state service. But many of the research projects have been very worthwhile." 

In the article, the Proposition 14 campaign, headed by Palo Alto developer Robert Klein, also continued its pattern of making exaggerated or misleading claims.  

"If we don’t continue the state funding, lots of facilities would have to close their doors,” says Kendall Klingler, the Proposition 14 spokeswoman....

"'We have more than 90 stem cell trials underway,' she says.

"The agency does have a record of some success: funding research that has led to treatments approved by the Food and Drug Administration (FDA) for blood and bone marrow cancers, for example."

Regarding the number of clinical trials funded by the research program, the agency itself only claims 64. The additional 30 or so trials are not funded by the California Institute for Regenerative Medicine (CIRM), as the agency is officially known. They utilize a piece of CIRM-financed research, however tiny, someplace along the way. And not necessarily a significant piece. 

The FDA treatments mentioned are not stem cell treatments, which is what was promised by the 2004 campaign. The agency has not funded any research that has resulted in a stem cell therapy that is available to the general public. 

And it is simply not accurate to say that "lots" of stem cell facilities partially financed with CIRM cash will be closing. All of them are occupied and fully in use. The recipients of the facilities grants, such as Stanford and UC San Francisco, are exceedingly unlikely to close the buildings.

Skelton concluded that CIRM has "failed to live up to its original hype." He said, 

"It was aloof to Sacramento, and not subject to oversight by the Legislature and governor. There’s been a lack of transparency.

"There was also an odor of interest conflicts among agency board members who seemed to steer grants toward their own institutions, even though they recused themselves from voting."

(In the interest of full disclosure, I worked for Skelton in the Capitol bureau of United Press International in the 1970s when he was bureau chief there.)

Over at Politico, Victoria Colliver wrote,  

"It's not clear that the Yes on 14 campaign's $15 million, even with a campaign that features actor Seth Rogen as “Stemmy the Stem Cell," will get the job done.

"'We’re running against Covid-19. That’s our real opposition,” said Robert Klein, the wealthy real estate investor and attorney who authored both measures and is the main funder of Prop. 14, along with Dagmar Dolby, the widow of inventor and sound engineer Ray Dolby.

"The differences between 2004 and 2020 are stark.

"Back then, Klein and other proponents had a ready-made argument by pointing to President W. Bush's prohibition on federal funding for embryonic stem-cell research, a stance supported by the religious right. In the nation's biotech capital — with an electorate dominated by Democrats and independent voters that support abortion rights — stem-cell backers made the case that California needed to step in to keep research alive.

"Many of the promises made 16 years ago, including its projections in royalties and state revenues from new treatments, have not borne out. Funding from the agency has supported more than 60 clinical trials, but CIRM has yet to fund a single stem-cell therapy approved by the U.S. Food and Drug Administration for widespread use."

Proposition 14: The Latest News and Opinion, STAT to Capitol Weekly

The national biomedical news service STAT today took a look at California's $5.5 billion stem cell measure, declaring it was backed by a "well-financed campaign that’s making heady promises about curing diabetes, paralysis, cancer, and Parkinson’s and Alzheimer’s diseases."

The headline on the story by Usha Lee McFarling said,

"With wildfires burning and Covid-19 spreading, can California afford stem cell research? Voters are set to decide"

McFarling's story was one of the more detailed that have appeared so far either nationally or within California.

She had this observation from a Los Angeles specialist on ballot initiatives, which is the direct democracy tool that Robert Klein, a Palo Alto real estate developer, used to place Proposition 14 on the ballot.

"John Matsusaka, an economist who heads the Initiative and Referendum Institute at the University of Southern California. He said federal funding restrictions that fueled support of Proposition 71 are no longer a major concern, proponents have not done a great job demonstrating that voters got their money’s worth from the first $3 billion, and the measure is coming to voters during tough fiscal times." 

In 2004, Proposition 71, also created by Klein, established the state stem cell agency, known officially as the California Institute for Regenerative Medicine (CIRM), and provided it with $3 billion. The money is nearly gone.  CIRM is set to begin closing its doors this winter unless Proposition 14 is approved. 

Mentioned or quoted in the STAT story were Alan Trounson, former CEO of CIRM, researchers Larry Goldstein of UC San Diego, Irv Weissman of Stanford, Jeanne Loring of Aspen Neurosciences, Inc., Andy McMahon of USC, and Jan Nolta of UC Davis. Others included CIRM governing board members Joe Panetta and Jeff Sheehy, and Melissa King, executive director of Americans for Cures and the head of field operations for the campaign group "Yes on 14." 

The STAT piece dealt with the range of pro and con arguments, including conflicts of interest. 

"'The people who decide who is going to get funded are the people who get funded. That’s a built-in conflict of interest they made no attempt to fix,' said John Simpson, who monitored CIRM for many years as stem cell project director for the group Consumer Watchdog. 'They need to go back to the drawing board and fix these structural flaws.'"

"Some of the conflicts have been so flagrant as to be almost comical. For example, former CIRM President Alan Trounson once asked prominent biochemist Leroy Hood to be a reviewer of a grant by Irv Weissman, the director of Stanford’s Institute for Stem Cell Biology and Regenerative Medicine, after the three men spent time fly fishing together on a Montana ranch jointly owned by Weissman and Hood."

Also appearing today was an opinion piece on the Capitol Weekly online news service by Pete Shanks, who has written about CIRM for years on the blog, Biopolitical Times. 

He cited the much-discussed issues surrounding the stem cell agency and wrote 

"Proposition 14 could have addressed these defects. Instead, it made them worse: It enlarges the board to 35 members, still mostly drawn from representatives of the universities, companies, and research institutes that receive its grants."

Shanks also said, 

"The 2004 proposition campaign has been widely criticized for hype: over-promising the imminence and certainty of breakthroughs. The advocates called their operation 'Cures for California,' but these have been in short supply. They also said that stem cell research would enormously reduce California’s medical costs, but there’s no sign of that.

"The campaign for Proposition. 14 follows the same pattern. It claims that the new multibillion-dollar investment has 'massive savings potential' and a 'low impact' on the budget. Skepticism is definitely in order."

*****

​Read all about California's stem cell agency, including Proposition 14,  in David Jensen's new book. Download it from Amazon:  California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures. Click here for more information on the author. 

Proposition 14: Stem Cell Balderdash at Sacramento Bee

Has California's stem cell program "relieved the suffering of millions?” The Sacramento Bee thinks so, but the assertion is totally false. 

It was contained in an editorial today that endorsed Proposition 14, which would save the state stem cell program from financial extinction along with broadly expanding the scope of the agency, known formally as the California Institute for Regenerative Medicine (CIRM). 

The agency was created in 2004 and was given $3 billion that the state borrowed. The cash is now running out. And the agency will begin closing its doors this winter without a massive infusion of money. Proposition 14 provides $5.5 billion. 

During its nearly 16 years, the agency CIRM has not yet funded research that has led to a stem cell treatment widely available to the public and approved by the federal government. 

It has helped to fund 64 clinical trials, which are a necessary prelude to commercializing a therapy. Some 30,000 patients would have to be enrolled in each of those trials to bring the "relieved-suffering" figure to two million.

The “suffering of millions” rhetoric was not the only case where the editorial echoed campaign hype. The Bee also said that the measure would cost only “$5 per person per year for 30 years,”  repeating an unsubstantiated assertion by the campaign. It may or may not be accurate, but it would involve a series of calculations and assumptions that the campaign is unwilling to share with the public. 

The California Stem Cell Report asked the campaign 53 days ago how it came up with the figure. The campaign still has not responded, which is a reasonable indication that the campaign lacks confidence in the number, to put it mildly.   

The editorial is behind a paywall. If you would like to see a copy, please email djensen@californiastemcellreport.com.

Prop. 14 Media Coverage from Capitol Weekly and California Healthline

The campaign on behalf of a $5.5 billion stem cell ballot measure this week placed an opinion piece on Capitol Weekly, and California Healthline separately offered up a news overview of the proposal, Proposition 14. 

The measure would save the California stem cell agency from financial extinction and broadly expand its scope into new areas ranging from mental health to "aging as a pathology." The agency is running out of the $3 billion that voters provided nearly 16 years ago and will begin closing its doors this winter without a major cash infusion. 

The piece on Healthline referenced the 2004 ballot initiative that created the agency. The article by Rachel Bluth said,

"During that first campaign, voters were told research funded by the measure could lead to cures for cancer, Alzheimer’s and other devastating diseases, and that the state could reap millions in royalties from new treatments.

"Yet most of those ambitions remain unfulfilled."

The article continued,

"The campaigns for both bond measures may be giving people unrealistic expectations and false hope, said Marcy Darnovsky, executive director of the Center for Genetics and Society. 'It undermines people’s trust in science,' Darnovsky said. 'No one can promise cures, and nobody should.'

"Robert Klein, a real estate developer who wrote both ballot measures, disagrees.... He said some of (the agency's) breakthroughs are helping patients right now.'

"'What are you going to do if this doesn’t pass? Tell those people we’re sorry, but we’re not going to do this?' Klein said. 'The thought of other children needlessly dying is unbearable.'"

California Healthline is independently published by Kaiser Health News for the California Health Care Foundation.

The Capitol Weekly piece was written by Tracy Grikscheit, chief of pediatric surgery at Children’s Hospital Los Angeles, who has received nearly $15 million from the stem cell agency. Children's has received more than $32 million from the agency. It has a longstanding relationship with the University of Southern California, which has received more than $114 million from the agency and which has also had a representative on the agency's board for a number of years in the past.

The Capitol Weekly article largely consisted of well-worn information from the campaign for Proposition 14.  Capitol Weekly is an online news service covering state politics and government.

Prop. 14 News Coverage: The 'Nuanced Track Record' of the California Stem Cell Agency

California's $3 billion stem cell agency, which is facing a life-and-death test on this fall's ballot, was described this week as chalking up a "nuanced track record" in an article carried by the online news service CalMatters. 

The article recounted the history of the agency since 2004, when it was created by a ballot initiative, Proposition 71. Today, the agency is running out of money and hopes voters will approve Proposition 14, a $5.5 billion ballot measure that also makes extensive changes in the scope of the agency. Without substantial funding, it will begin closing its doors this winter. 

CalMatters is a nonpartisan and nonprofit online news site devoted to state government and politics. The piece by Barbara Feder Ostrov said,

"This time, embryonic stem cell research is in a much different place, with federal funding no longer blocked and more funding from the biotech industry.

"Voters will want to consider what California’s previous investment in stem cell research has accomplished. It’s a nuanced track record.

"While many scientific experts agree that Prop. 71 (of 2004) was a 'bold social innovation' that successfully bolstered emerging stem cell research, some critics argue that the institute’s grantmaking was plagued by conflicts of interest and did not live up to the promises of miracle cures that Prop. 71’s supporters made years ago. Although the agency is funded with state money, it’s overseen by its own board and not by the California governor or lawmakers."

The "social innovation" comment was contained in a 2012 blue-ribbon study of the agency, commissioned by the agency itself for $700,000. The study also said that the agency has substantial built-in conflicts of interest on the governing board of the California Institute for Regenerative Medicine (CIRM), as the agency is officially known. 

The California Stem Cell Report last month performed an analysis of CIRM awards that showed that 79 percent of the $2.7 billion in grants has gone to institutions that are linked to members of its governing board. 

Ostrov's article additionally said, 

"A June 2020 analysis by University of Southern California health policy researchers estimated that taxpayers’ initial $3 billion investment in the research institute helped create more than 50,000 jobs and generated $10 billion for the state’s economy."

The stem cell agency commissioned the report at a cost of $206,000.

Ostrov noted substantial opposition in editorials in California newspapers. 

"The editorial boards of some of California’s biggest newspapers...have opposed the measure, including the Los Angeles Times, the Orange County Register, the San Francisco Chronicle and the San Jose Mercury News/East Bay Times. The Fresno Bee, Modesto Bee, and San Luis Obispo Tribune newspaper editorial boards support Prop. 14." 

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​Read all about California's stem cell agency, including Proposition 14,  in David Jensen's new book. Buy it on Amazon:  California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures. Click here for more information on the author.

Tangling Over $5.5 Billion Stem Cell Measure: CIRM Board Member vs. its Former Chairman

Robert Klein is on the left, Jeff Sheehy on right at CIRM
directors meeting. Art Torres, vice chair of the board is in
the middle. CSCR photo

The two men once worked together over the last 16 years to spend $3 billion in state funds on stem cell research in California. This week, however, they were very publicly on opposite sides of a ballot initiative to spend $5.5 billion more. 

The initiative is Proposition 14, which would require the state to borrow the additional billions. The measure would also substantially expand the scope of the state stem cell agency, known formally as the California Institute for Regenerative Medicine (CIRM).  

Both men, Robert Klein and Jeff Sheehy, served on the CIRM board, regularly approving hundreds of millions of dollars in research awards annually. Klein is a Palo Alto real estate developer and was the first chairman of the agency. He directed the writing of Proposition 14 and now heads the campaign.  He left his post as chairman in 2011.

Sheehy continues to serve on the CIRM board and has since 2004. He is a patient advocate member of the board, its former Science Subcommittee chair and a nationally recognized HIV/AIDs advocate. Sheehy was the lone dissenting vote when the CIRM board endorsed Proposition 14 in June, although he says the agency has done "tremendous" work.

They came together "remotely" when they participated Oct. 5 in a public radio show, KQED's Forum with Michael Krasny, that is heard throughout California on public radio stations. 

Klein and Sheehy bristled at times during the 38-minute broadcast. Klein said figures presented by Sheehy were "completely false." Sheehy said Klein's financing mechanism in Proposition 14 was "very dodgy" and "ridiculous." 

In the initial years of financing, Sheehy said, "It's like getting a credit card and then getting another credit card to carry the interest (from the first credit card)."

Longstanding issues were also raised concerning conflicts of interest on the CIRM board and other deficiencies identified in an evaluation of CIRM by the prestigious Institute of Medicine (IOM). The 2012 study was commissioned by CIRM itself at a cost of $700,000. Both Klein and Sheehy supported funding the study as a way to secure what they thought would be a gold standard endorsement of the agency. 

Klein's initiative does little to deal with the issues raised by the study, which said "inherent conflicts of interest" exist on the board. The report also recommended that the 29-member board be overhauled completely and not expanded.  Proposition 14 would increase the board size to 35, however, increasing conflicts of interest. The measure also does not address the management and governance problems cited by the study.

An analysis last month by the California Stem Cell Report showed that 79 percent of the awards approved by the CIRM board went to institutions that had links to board members even though the "institutional" members are not permitted to vote on awards to their institutions. Conflicts of interest have been so pervasive at times that only six or seven members were allowed to vote on awards. 

Sheehy and Klein also talked briefly about state spending priorities in the Covid year and the state's ongoing affordable housing, education and homeless problems. Overall, the KQED program provided only a tiny peek at the issues involved in Proposition 14. 

Klein's position can be fully explored on his campaign's web site. Over the last 12 months, Sheehy has aired his position at CIRM board meetings and in submissions to the California Stem Cell Report. Here is what Sheehy wrote regarding his no vote on endorsement of the ballot measure.

A detailed look at the findings of the IOM report and the current status of CIRM's response is contained in the new book "California's Great Stem Cell Experiment: An Inside Look at a $3 Billion Search for Cures."  The book was written by the publisher of this blog and grew out of more than 15 years of close observation of the stem cell agency. 

CIRM Board Member Calls Proposition 14 'Fatally Flawed' and 'Unaffordable"

The San Diego Union-Tribune this morning carried an op-ed piece by a long-time director of the California stem cell agency that said this fall's $5.5 billion ballot stem cell ballot measure is "unaffordable, unnecessary and fatally flawed." 

The article was written by Jeff Sheehy, an HIV/AIDS patient advocate member of the agency's board and who was also chair of the board's Science Subcommittee. He has served on the board since the agency was created in 2004 and funded with $3 billion that is now nearly gone. 

The ballot measure, Proposition 14, would save the agency from financial extinction. 

Sheehy's column began:

"It must seem odd that someone who has spent countless hours over the last 15 years as a member of the governing board of the California Institute for Regenerative Medicine (CIRM) would oppose Proposition 14, which seeks to provide $5.5 billion in new funding for the stem-cell agency. While I value CIRM and its work to date, Proposition 14 commits California to spending money it does not have — $7.8 billion including interest for research that is already well-funded. Plus, CIRM’s pre-existing flaws are actually exacerbated by new provisions in the measure."

(The stem cell agency is officially known as the California Institute for Regenerative Medicine.) 

Sheehy's views are not entirely unknown, but the newspaper piece reaches a significantly different and larger audience. Plus San Diego is a hotbed of biotech. Its institutions and businesses have benefited mightily from funding by the agency.

UC San Diego has received $232 million, Salk Institute $53 million, Scripps Research Institute $51 million, the Sanford Consortium $43 million and Viacyte, Inc., $72 million. Among businesses supported by CIRM, Viacyte is No. 1. 

Sheehy said,

"And after spending all of that money, not a single U.S. Federal and Drug Administration-approved product has materialized on which CIRM’s funding played an important role." 

 Sheehy cited the financial costs of the agency as one major reason for his opposition to Proposition 14.  Combined with the $3 billion in state bonds provided in 2004, Sheehy said, 

"Proposition 14 will add at least another $260 million a year in annual repayments. That means California taxpayers will be on the hook for $587 million a year for stem-cell research. Remember state imperatives such as education, health care and housing are not only chronically under-resourced, but with a looming deficit, will be starved for funding because bonds must be repaid first. Cuts have already happened and more are likely on the way. Critical needs will go unfunded."

Sheehy also said that Proposition 14 fails to fix "severe flaws" in the measure that created CIRM. including the "absurd requirement" for a super, super-majority of the legislature to make even tiniest corrections in the existing law. 

He said the state is not receiving an adequate financial return on CIRM-funded inventions. He said "in practice" the provisions of Proposition 14 would undermine existing CIRM rules about "access and fair pricing." He said,

"It would require that any returns from the state’s investment in new therapies are given back to pharmaceutical and biotech companies, thus freeing them from any price restraints since CIRM will be making up the difference. This change is a blatant giveaway to those companies."

Sheehy concluded, 

"Unaffordable, unnecessary and fatally flawed, Proposition 14 is unsupportable. If California is going to continue to spend billions to fund stem-cell research, the Legislature should draft a new measure that does it the right way."

Sheehy said the San Diego newspaper solicited the article. Sheehy was the lone dissenting vote in June when the CIRM board voted to endorse Proposition 14.  His views on the proposition have been aired at some length on the California Stem Cell Report.  The text of his comments last October can be found here. The remarks in June can be found here.

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​Read all about California's stem cell agency, including Proposition 14,  in David Jensen's new book. Buy it on Amazon:  California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures. Click here for more information on the author.

Bakersfield Californian Says No to Proposition 14, the Multibillion-Dollar Stem Cell Measure

The Bakersfield Californian is likely the first paper in the state to take a stand on the $5.5 billion California stem cell measure, advising its readers to reject the "mega-bond" as financially unwise. 

In an editorial published online yesterday, the newspaper said, 

"As California continues to struggle under the catastrophic burden of the coronavirus pandemic, increasing state budget deficits loom, public service cuts are likely and economic recovery is likely to take more than a decade.

"In 2009, President Barack Obama lifted most of the restrictions on federal funding for embryonic stem cell research and demand for the cells has been greatly reduced as other research and technologies have advanced.

"Adding $5.5 billion to the state debt for just stem cell research would be unwise in these economically dire times. Vote NO on Proposition 14."

The newspaper also said that the agency, officially known as the California Institute for Regenerative Medicine (CIRM),  "created an impressive infrastructure of research institutes." The Californian continued,

"Stem cell research greatly advanced in California, but the promised spectacular breakthroughs have lagged – a result of the tedious and time-consuming nature of research.... 

"Voters and earlier proposition advocates should be proud of the progress the initial $3 billion stem cell investment has accomplished. But times have changed and passage of another mega-bond now would be unwise."

How important are newspaper endorsements nowadays? They are one concrete standard that campaign managers can be measured against, so they may take on outsized importance. But newspapers are a dying breed, reaching fewer and fewer readers. Even in their heyday, decades ago, only about 25 percent or so of readers turned to the editorial pages on a regular basis. 

However, a wave of negative editorials could take on a life of its own, leading to mentions in the coverage of Proposition 14 as an indicator that the measure is in trouble.  That said, don't expect heavy coverage of the proposal. 

Both print and online news media are short-staffed. Most of their efforts will focus on higher-profile issues, including presidential matters, local ballot races and other propositions, such as rent control and property taxes involving the state's sacrosanct Proposition 13. 

And for the record, Proposition 14 will cost taxpayers an estimated $7.8 billion because of the interest on the $5.5 billion that the state will have to borrow.

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Read the California Stem Cell Report regularly for the latest and most in-depth coverage of the effort to save the stem cell agency from financial extinction. 

Saving CIRM: $5.5 Billion Ballot Campaign, Rhetoric and Winning

The campaign to save California's financially strapped stem cell research agency said this week that voter approval of a $5.5 billion rescue measure "has never been more important to the future of California’s health care, for the patients and their families, than it is now."

The pitch came in an opinion piece carried on the Capitol Weekly online news service. The article appears to be the first "op-ed" piece that the campaign has placed since qualifying the ballot initiative, Proposition 14. 

The article carried the byline of Robert Klein, chairman of the campaign effort, Californians for Stem Cell Research. Klein is the Palo Alto real estate developer who led the 2004 ballot campaign and directed the writing of the original initiative as well as the current one. He also was the first chairman of the agency, known officially as the California Institute for Regenerative Medicine (CIRM). 

Klein's article echoed rhetoric from the campaign web site, in some cases using identical phrasing, which is to be expected.  He wrote,

"CIRM funding has advanced research and therapy development for more than 75 different diseases and conditions, more than 90 clinical trials, more than 1,000 medical projects at 70 institutions across California and nearly 3,000 published medical discoveries. This investment has already saved and improved lives, including a high school student who was paralyzed in a diving accident and was able to regain function in his upper body and go on to college, a mother who went blind from a genetic disease has had some of her eyesight restored, two FDA-approved cancer treatments are already saving lives, and many more."

Klein's campaign piece pushed the envelope in some cases. One example is the mention of "more than 90 clinical trials." The agency itself only claims 64. The key to Klein's figure of 90 is the phrasing "CIRM funding has advanced ... more than 90 clinical trials." That is a different criteria than used by the agency. Klein is basing his figure on any kind of research connected in any way to any kind of trial. 

Klein's number of 90 has also climbed from 80 just 16 days ago.  

Additionally, Klein's claims in his article for the agency's economic benefits are based on studies that the agency itself has paid for as opposed to independent, third party analyses. The most recent example came last fall; the study cost CIRM $206,000. 

The 2004 campaign that established the agency was widely criticized for its hype. Most ballot campaigns can be criticized on the same grounds. However, none have dealt with science in the way that Proposition 14 does. But Klein's job is to win approval of the proposal. Without a victory in the fall, CIRM will begin to close its doors. 

California voters can expect to see more rhetoric like Klein's over the next three months or so, intensifying significantly in October. The same sort of rhetoric is  already coming from the opposition and can be more extreme. As the ChurchMilitant web site said on June 29, 

"California state officials have confirmed a ballot initiative that, if approved, would give a state biomedical agency $5.5 billion to kill human embryos in order to extract their stem cells."

All this -- Klein's envelope-pushing and opponents' emotional, religious screeds -- is part of the way ballot campaigns work in California. Cautious, deliberative discussions cannot be expected to carry the day for the partisans on both sides. It is war with a deadline. 

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​Read all about California's stem cell agency, including Proposition 14,  in David Jensen's new book. Buy it on Amazon:  California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures. Click here for more information on the author.