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.

California's Five-Buck Stem Cell Mystery and Prop. 14 Campaign Hype

The campaign to save California's stem cell agency with a $5.5 billion cash infusion is peddling a variety of claims that stretch the facts or that the campaign is unwilling to support publicly.  

Leading the pack is the assertion that the multibillion-dollar proposition will cost no more than a bottle of aspirin per person, per year. Unspecified by the campaign, however, is the number of persons and the number of years. The five-buck claim is clearly an attempt to minimize the cost of the proposal, which actually totals an estimated $7.8 billion, according to the state's legislative analyst. 

Robert Klein, leader of the Proposition 14 campaign, made the five-buck claim back in July. It has also appeared on the campaign web site. And Klein brought up the figure again this month in a radio broadcast.

"Proposition 14 will cost the state an average of less than $5 per person, per year – about the cost of a bottle of aspirin" is the way Klein put it last summer.

The California Stem Cell Report has asked the campaign several times to explain how it arrived at that figure. The first request was made 44 days ago (Sept. 1). The campaign has not responded. 

On Oct. 5, Klein brought up another number during a KQED broadcast. He said $4.1 billion was put into CIRM research in 2019 via matching funds. The state stem cell agency declined to verify that figure. A query to the campaign has not been answered. 

The campaign additionally uses a figure of 90 to describe the number of clinical trials in which the stem cell agency is involved. The agency, which is known officially as the California Institute for Regenerative Medicine (CIRM), says that it is  involved in 64.  That is a more than respectable number, more than Klein would have predicted back in 2005 when he was the first chairman of CIRM.

The campaign's justification for using the larger figure seems to be that somehow, someway, that some piece of CIRM-funded research, however tiny, has played a role in some sort of trial. By that criteria, John J. Loud could be also credited with contributing to a CIRM-backed clinical trial. He invented the ballpoint pen in 1888.  

Over the past several years, the agency, during public meetings, has been careful to limit its focus on clinical trials to those that involve meaningful financial participation, for which it deserves ample credit. (It should be noted that the number has grown as CIRM has helped to fund more trials.) 

Pushing the envelope is normal practice for ballot campaigns. It may be unrealistic to expect the stem cell campaign to behave any differently.  Winning is everything in an election campaign. As I have remarked in the past, a ballot campaign is like a war with a deadline. The losers are like so much charnel on the electoral battlefield.

That said, Proposition 14 involves the credibility of science, a matter much in the news nowadays. And backers of the stem cell initiative continue to suffer from the ill effects of the hype of the 2004 campaign, which was also led by Klein. 

The excessive and unrealized voter expectations raised by 2004 campaign are popping up this year in news stories and editorials about Proposition 14 in a way that does not improve its chances of approval, at least for some people. Of course, constant repetition of misleading or bogus information can have an impact on some voters as the country has seen on a national level. 

Art Caplan, a nationally prominent bioethicist, said in 2014, 

“Stem cell research seems, again and again, to go off the rails when it comes to the ethics of research.”

Caplan was speaking mainly about hyped claims involving stem cell research that could not be replicated. The general concern, however, remains alive.

In 2016, five researchers highlighted ongoing issues involving stem cell hype in a piece in the journal Science, They wrote,

"This (trend) raises the risk of harmful consequences, including misleading the public, creating unrealistic expectations, misinforming policy debates, devaluing methodical approaches to research, and driving premature or unwarranted clinical use. This is particularly important in light of mounting concern about the marketing of unproven stem cell treatments. This trend may have led to a gap between public expectations and the actual state of stem cell science and clinical development."

More recently in California, Hank Greely, director of Stanford's  Center for Law and the Biosciences, this week was quoted in an article about Proposition 14.  He said, 

“Politics has a corrupting influence on everything — it pushes toward exaggeration." 

As for what that means for voters evaluating Proposition 14 and the claims of its backers and opponents, the ancient admonition of caveat emptor would seem to be the order of the day -- buyer beware.  That is a deeply unfortunate position for those who believe that the nation should trust science.  

(Editor's note: This is an updated and lightly edited version of an earlier version of this item.) 

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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.

Deletion and Explanation

An erroneous item involving the removal of a CIRM board member appeared very briefly this afternoon on the California Stem Cell Report. It was premised on inaccurate information contained in a CIRM news release from 2012. The item was deleted minutes after we were alerted by CIRM regarding the incorrect information in its press release. 

'Hobby Horse' to 'Stunning Progress:' Two Newspapers Look at California Stem Cell Program and the $5.5 Billion Prop. 14

Does California's stem cell research program, now facing a $5.5 billion referendum, represent one person's "personal hobby horse" or does it represent "stunning progress" in developing therapies and cures?

Those are two questions embodied in two articles in major Californa newspapers this week about Proposition 14. The ballot initiative would provide the billions for the California Institute for Regenerative Medicine (CIRM), as the state stem cell agency is officially known. 

CIRM is running out of money and will begin closing its doors this winter unless Proposition 14 is approved. In addition to the $5.5 billion, the measure sets a new and expanded course for the agency, which has yet to help finance a stem cell therapy that is widely available to the public after working on the matter for nearly 16 years. 

Lisa Krieger, writing in what the San Jose Mercury News called an "analysis," related a number of  CIRM achievements, ranging from providing more than $200 million in "elegant buildings" to familiar anecdotes about patients who have been helped in clinical trials at least partially supported by CIRM. 

She said, 

“'CIRM has supported some really superb research and researchers and built a powerful infrastructure,' said Robert Cook-Deegan of the School for the Future of Innovation in Society at Arizona State University. 'In a field where there aren’t as many other sources of funding, that’s almost certainly, in the long run, a good thing.'"

"This is stunning progress..." Krieger wrote. "Still, it falls far short of Proposition 71’s breathless rhetoric from the 2004 campaign."

In the Los Angeles Times, Michael Hiltzik, a business columnist and author of "Big Science," said Proposition 14 "is a perfect example of the drawbacks of allowing a public program to turn into one individual’s personal hobby horse."

Hiltzik said, 

"In this case, the individual is Robert Klein II, a Northern California real estate developer who drafted and promoted Proposition 71 of 2004, the $3-billion initiative that created the program formally known as the California Institute of Regenerative Medicine, or CIRM, and who led the program as chairman during its formative years. Klein has contributed more than $6.6 million to the initiative campaign.

"CIRM has funded much worthy scientific research. But it has struggled since its creation with the outsized expectations that Klein’s advertising campaign for Proposition 71 engendered — namely, that the program would yield 'cures' for conditions including Parkinson’s, Alzheimer’s and diabetes."

Hiltzik's comments were part of a longer roundup of his thoughts on the ballot propositions that face California voters this month. He said he would vote with "regret" against the measure and referenced a longer piece that he wrote last December dissecting Klein's ballot measure and the issues have troubled CIRM.

In it, he said that Proposition 14 "perpetuates many of the original measure’s flaws and makes some of them worse. 

"That’s dangerous, because although the measure could fuel the stem cell program for years to come, it might also prompt a repudiation by voters sensitive to its many imperfections. Such an outcome would be tragic for California and the advanced science already supported by CIRM." 

The Los Angeles Times claims about 1.3 million readers daily. The San Jose Mercury is part of a newspaper chain that circulates its articles widely in the San Francisco Bay area.

Krieger and Hiltzik both were around for the 2004 ballot campaign that created CIRM in 2004 through Proposition 71, another ballot measure crafted by Klein. It ran only 10,000 words. Proposition 14 contains about 17,000 words.

I should note that Proposition 14 is technically not a ballot referendum but a ballot initiative. However, the measure effectively serves as a referendum on CIRM's past and likely future performance.

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To read more on CIRM, its performance and Proposition 14, see David Jensen's news book: ​California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures. Click here for more information on the author.

Stem Cell Scientist Jeanne Loring on hESC Research, Proposition 14 and California Stem Cell Agency

(Editor's Note: The following commentary concerning the California Institute for Regenerative Medicine (CIRM) and Proposition 14 was submitted to the California Stem Cell Report by Jeanne Loring, professor emeritus from the Scripps Research Institute and co-founder of Aspen Neuroscience, Inc., of San Diego.)

By Jeanne Loring

"Long ago, when Bob (Klein) and Jeff (Sheehy) were both CIRM’s oversight board members, their arguments were legend. I was at the meetings for most of them.

"After listening to the broadcast (KQED’s Forum), I want to make 3 points:

"I want to once more correct the idea that George Bush banned embryonic stem cell research; he did not, and I was disappointed that KQED perpetuated that misconception.

"In 2004 when Prop. 71 was on the ballot, I was already receiving funding from the NIH for human embryonic stem cell research. Bush’s decision was NOT to ban hESC research, but was in fact the opposite. He decreed that hESC research could receive NIH funding for the first time. In effect, he REVERSED A BAN. On the 9th of August 2001, a group of us who had already made hESC lines with private funding became eligible, for the first time, to receive NIH funding. Article: Stem cell research gets federal OK, Aug. 9, 2001.

"In 2004 when voters were approving Proposition 71, there were NIH grants funded for Jamie Thomson in Wisconsin, for Bresagen in Georgia, for several groups in other countries, and for Roger Pederson (UCSF) and me in California. Here’s an announcement from UCSF on September 17, 2002: UCSF begins distributing the first of its two embryonic stem cell lines.

"I supported Prop 71 not because it was necessary, but because it would make California an embryonic stem cell research juggernaut. I believed in the potential of embryonic stem cells and CIRM gave me the opportunity to prove it.

"Bob Klein and I used to talk often, and I admire him for his persistence in getting CIRM established. But as time passed, he seemed to tire of my opinions. Last year I published an opinion piece in Nature that pointed out the unanticipated parallel growth of legitimate stem cell research and charlatan “stem cell” clinics: World View Nature. I immediately received this message from Americans for Cures (Bob Klein’s organization).

'Dear Jeanne,

'On behalf of the organization, I must let you know the following. 

'Unfortunately, Americans for Cures must remove you from its Scientific Advisory Board, effective immediately. Your views in the recent article in Nature are not consistent with the views of Americans for Cures as to CIRM and the importance of CIRM’s accomplishments.'

""I have mixed feelings about Prop. 14. I have benefited greatly from CIRM funding, and after many years of CIRM funding, I was able to attract private venture funding to launch a company developing a cell replacement therapy for Parkinson’s disease.

"'But I agree with Jeff Sheehy that the current measure does not fix the flaws in Prop 71. Having watched the process of approving grants by the oversight board (ICOC) for 13 years, I came to the conclusion that because the Board was made up largely of members representing institutions that were competing for grants, bias was unavoidable, and the large size of the Board, 29 members, was a detriment. The current proposition, Prop. 14, makes the situation worse by increasing the number of board members to 35 and not fixing the conflicts.

"There is a moment at which one’s trust in an organization is dashed. For me this it was this event: the president of CIRM was hosted by a professor at Stanford for at least 2 luxurious fishing trips in Montana and Alaska. This president then argued strongly in favor of large grants to Stanford, and also grants to a company that that same Stanford professor had founded. Finally, when the president stepped down from CIRM he waited less than a week before taking a paid position on the board of the company that he supported for CIRM funding. It was then that the full impact of the intrinsic bias became real to me."

(Editor's note: The reference to the president of CIRM is to its former president Alan Trounson. The reference to the Stanford University professor is to Irv Weissman.)

Proposition 14 Campaign Coverage: George Bush, 'Blatant Giveaway' and $5.5 Billion More

Northern California's respected KQED news site has aired an overview of Proposition 14, the far-reaching, $5.5 billion measure to continue funding of stem cell research by the state of California.

The piece by Danielle Venton covers a bit of the history of the state stem cell agency, the "debt" it owes to former President George Bush and the progress of the agency, known formally as the California Institute for Regenerative Medicine (CIRM). Venton wrote,

"The pace of innovation has been slower than many hoped. As it turned out, grand discoveries were not around the corner, and to date there is no widespread stem cell treatment approved for the public. To date, CIRM has funded more than 64 trials directly and aided in 31 more. Not all have or will result in treatments.

"But despite the lack of a marquee cure like one for Alzheimer’s or Parkinson’s, the agency has seen some notable triumphs."

Quoted by Venton were Jeff Sheehy, a member of the CIRM governing board; Melissa King, field operations manager for the campaign and executive director of the nonprofit Americans for Cures, and David Jensen, author of "California's Great Stem Cell Experiment" and publisher of this blog.

Proposition 14 would save CIRM from financial extinction. It is slated to begin closing its doors this winter as its original $3 billion in funding is running out. The agency was created by Proposition 71 of 2004, which raised high expectations of cures.  Venton wrote,

"Right now the state still owes about $1 billion toward the debt created by Proposition 71. If Proposition 14 passes, the yearly price tag to pay off the new bond would be about $260 million per year for about 30 years.

"Funding needs for stem cell research also are not as acute as they were back in 2004. The federal National Institutes of Health now funds some basic stem cell research, spending about $2 billion a year, with $321 million of that going toward human embryonic stem cell research. And private ventures, like nonprofits started by tech billionaires, are pouring more money into biotech."

Venton wrote,

"Proposition 14 makes it impossible for the state to use profits from its investment on, say, schools or other funding priorities. Instead, any royalties earned must be fed back into programs to make CIRM-funded treatments more affordable. 

"'What it does is it basically takes all of our returns that we get from this and gives it back to the pharmaceutical and biotech companies,' said Sheehy. 'It becomes just a blatant giveaway to these companies when we should be requiring access and requiring fair pricing.'"

King said that "CIRM fills a neglected funding need," Venton wrote.

"'The NIH (federal funding agency) does not fund clinical trials at nearly the rate that CIRM can and has been,' King said.

"She says that's important because of what she calls the 'Valley of Death,' where promising early-stage research frequently fails to translate into promising treatments that can be tested in clinical-stage research. (What works well in a test tube often does not work well in an organism.) This weeding-out process is costly but necessary. And it’s where CIRM focused a lot of its effort."

LA Times Runs Down the Middle in News Report on $5.5 Billion Stem Cell Ballot Initiative

California's largest circulation newspaper, the Los Angeles Times, this week published an overview of the state's $5.5 billion stem cell ballot measure that was headlined:

"With Prop. 14, California voters will be asked for more borrowing to keep stem cell research going"

The article by Melody Gutierrez played the issues pretty much down the middle. However, backers of the measure, Proposition 14, likely are not happy with the headline. They would have preferred one that focused on how they think the measure would save lives. 

The ballot initiative is aimed at refinancing the state stem cell agency, known officially as the California Institute for Regenerative Medicine (CIRM) and which will be closing its doors this winter because it is running out of money. The measure would also substantially widen CIRM's scope. 

The Times piece article carries more weight than most news pieces on the proposal because of the Times' reach and reputation. The newspaper claims a daily readership of 1.3 million and a combined print and online local weekly audience of 4.6 million.

The article said,

"Proposition 14 has no organized opposition and, so far, no one willing to put their money into fighting it — but the measure does have critics. Newspaper editorial boards, including those at the Los Angeles Times and San Francisco Chronicle, have opposed it. Opponents include CIRM board member Jeff Sheehy, who says the state shouldn’t take on new debt while facing a pandemic-induced deficit and that medical advances attributed to the previous stem cell bond have been overstated."

The Times piece captured a bit of stem cell history:

"The campaign to pass the 2004 ballot measure told voters that the bond would save millions of lives and cut healthcare costs by billions. Critics say that’s not been the case to date, although supporters of this year’s measure note that they never intended those results within 16 years."

It should be noted that the "never intended" remark from Klein's campaign reflects a rewrite of history. The 2004 campaign was much criticized for its hype and raising voter expectations that stem cell cures were right around the corner.

Gutierrez also touched on the problem of finding financing at risky stages of research, writing,

"Alzheimer’s disease researcher Dr. Larry Goldstein, who works at UC San Diego, said the state’s stem cell agency fills a void in critical grant funding. He said industry, venture capital and federal funding is available, but often goes toward research showing promising results in late-stage trials. He said money is needed, however, to move a scientific discovery to that point. That gap, which he said is referred to as the “valley of death” in research, has been filled by CIRM grants.

"'It was getting more and more difficult to fund novel, risky and creative scientific projects,' Goldstein said. 'CIRM has done a good job of funding parts of my research that were particularly risky that have led to a particular payoff.'"

 The Times also reported,

"Sheehy said he’s been dismayed by claims now being made by proponents of Proposition 14 that he said mischaracterize some achievements as being the direct result of CIRM funding when the agency’s role was limited. If a major drug was developed with CIRM’s funding, the state would receive a royalty, patent or licensing revenue. To date, the agency has received $462,433, a fraction of what voters were told the state would take in."

Gutierrez concluded, 

'"The state can’t just keep giving money to this forever,' Sheehy said. 'It was never meant to be a permanent thing. It was for a specific unmet need that doesn’t exist anymore.'"

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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.

Head of Prop. 14 Stem Cell Campaign Schedules Internet Appearance for Tomorrow

The leader of the campaign to approve $5.5 billion for stem cell research in California is scheduled to appear on an Internet broadcast tomorrow during which he will deliver what the campaign calls an "important" and "special" message. 

The announcement of the appearance of Robert Klein came on short notice this afternoon. Klein, a Palo Alto real estate developer, not only heads the campaign but sponsored Proposition 14, the 17,000-word initiative that would greatly expand the scope of the California Institute for Regenerative Medicine (CIRM), as the state stem cell agency is officially known. 

The agency was created in 2004 through another ballot initiative, also sponsored by Klein, who became its first chairman under the terms of that stem cell initiative.  The $3 billion provided by the 2004 measure is all but gone, and the stem cell agency will begin closing its doors this winter without more cash. 

The announcement of the campaign event, which involves the campaign's student ambassadors, was made this afternoon by Melissa King, director of field operations for the campaign. King is also executive director of the nonprofit Americans for Cures, a stem cell advocacy group founded by Klein. 

King made the announcement in an email message to campaign supporters. She said  Klein would appear during the last half hour of a one-hour webinar at 12:30 p.m. tomorrow (Oct. 10) at 12:30 p.m. PDT.  Here is the Zoom link to join: https://us02web.zoom.us/j/89031672494

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. 

Head-to-Head on Proposition 14: 'Fatally Flawed,' Life-Saver or Both?

2012 CIRM video of Sandra Dillon (on right) and Catriona Jamieson of UC San Diego

Sandra Dillon says she owes her life to the California stem cell agency, and she wants California voters to give it $5.5 billion more to help save the lives of many more, including someone they love. 

Dillon made her comments in a piece carried last month in the San Diego Union-Tribune. Her article was paired with another commentary in the paper that strongly opposed Proposition 14 on this fall's ballot. It was written by Jeff Sheehy, a patient advocate member of the board of the California Institute for Regenerative Medicine (CIRM), the official name of the stem cell agency.  

Together, Dillon's and Sheehy's commentaries capture the essence of the arguments for and against the ballot initiative and highlight what is at stake this fall. And that is the continued existence of the stem cell agency, which was created in 2004 by another ballot initiative that provided it with $3 billion in money borrowed by the state. That funding is all but gone. If voters reject Proposition 14, CIRM will begin closing its doors this winter. 

(The actual cost to taxpayers, it should be noted, is about $4 billion in the case of the 2004 measure and an estimated $7.8 billion for Proposition 14.)

When Dillon was 28, she was diagnosed with a rare form of blood cancer called myelofibrosis. She wrote in the San Diego paper, 

"Upon learning of my cancer diagnosis, I was left feeling helpless, afraid and searching for answers about how this disease would affect my everyday life, what I could do to fight it, and how much time I had left to live....

"It is because of California’s forward-looking leadership in passing Proposition 71 in 2004 — hoping to find treatments and cures for chronic diseases and illnesses — that has allowed me to still be here today." 

Dillon concluded,

"The passage of Proposition 71 helped save my life. It is unimaginable to think that Californians would vote to discontinue this amazing effort — I don’t know where I would be or what condition I would be in if it wasn’t for the investment Californians made nearly two decades ago."

Dillon's experimental therapy involved research by Catriona Jamieson of UC San Diego, who has received $17.3 million from the stem cell agency.

In the other commentary, Sheehy, who has served on the CIRM board since 2004 and was chairman of its science subcommittee, was deeply critical. He was the only member of the CIRM to votes against endorsing the measure. 

The California Stem Cell Report carried a piece last month summarizing what Sheehy had to say in his piece, which was headlined,  "Why Prop. 14 is unaffordable, unnecessary, fatally flawed and unsupportable."

But to refresh readers, Sheehy, whose article was solicited by the newspaper, said, 

"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."

"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."

"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."

California's Alpha Stem Cell Clinic Network: Online Symposium Set for Thursday

Science Direct graphic

Californians -- not to mention the entire world -- will have a chance Thursday to get a close-up look at one of the signature efforts of the state's $3 billion stem cell agency -- the Alpha Clinic Network, which stretches from San Diego to Sacramento. 

The online occasion is the annual symposium for the network, which was started with $50 million from the stem cell agency, known formally as the California Institute for Regenerative Medicine (CIRM). 

The meetings have not always been available online.  This year, Covid-19 forced the session into cyberspace, making it available to vastly larger numbers of persons. 

CIRM's blog, The Stem Cellar, yesterday highlighted a couple of topics. Kevin McCormack, CIRM's senior director of communications, wrote, 

"One of the topics being featured is research into Covid-19. To date CIRM has funded 17 different projects, including three clinical trials. We’ll talk about how these are trying to find ways to help people infected with the virus, seeing if stem cells can help restore function to organs and tissues damaged by the virus, and if we can use stem cells to help develop safe and effective vaccines.

"Immediately after that we are going to use Covid-19 as a way of exploring how the people most at risk of being infected and suffering serious consequences, are also the ones most likely to be left out of the research and have most trouble accessing treatments and vaccines."

The agenda also includes a look at rare diseases and unmet medical needs. You can register for the event here. It begins at 9 a.m. PDT (4 p.m. Greenwich Mean Time).

"California's Great Stem Cell Experiment: Inside a $3 Billion Search for Cures:" A New Book on the State's Stem Cell Agency

David Jensen

A new book devoted to the life and times of California's nearly 16-year-old stem cell research program is now available on Amazon. The book chronicles the stem cell agency's story from its early days to its current imperiled existence. 

The book is called "California's Great Stem Cell Experiment: Inside a $3 Billion Search for Cures." It was written by yours truly, David Jensen, who has covered the agency since January 2005 and who has published some 5,000 items about the program on this blog, the California Stem Cell Report.

The book explores the agency's performance as 20 million Californians vote this month and next to decide whether to provide $5.5 billion more for the California Institute for Regenerative Medicine (CIRM), as the agency is officially known. Questions addressed include: 

• Has CIRM fulfilled the expectations raised by the 2004 campaign?
• Has its work since then been worth $4 billion (CIRM's cost including interest on the state bonds that finance its work)?
• What are the important elements and new directions created by Proposition 14 in addition to the $5.5 billion ($7.8 billion with interest), and does the measure fit with the state's current priorities? 

CIRM is unique in California's history, which has never seen an enterprise like this. It is also unique nationally. No other state has launched a scientific stem cell program of this magnitude.  And it is an agency that operates outside of the bounds of what many consider normal state government controls and finance. 

At the same time, even its opponent will acknowledge the significance of CIRM's work, which includes helping to finance 64 clinical trials and the creation of what it calls an Alpha Clinic Network throughout the state. 

In 2012, CIRM heard from the Institute of Medicine, which CIRM hired to conduct a $700,000 examination of the agency's work. The book re-examines the IOM findings, which were both laudatory and critical, and reviews CIRM's response.  

Along with critics, the book brings to readers the voices of CIRM supporters, its executives and former officials, including the first president of the agency, Zach Hall; its first chairman and leader of the 2020 campaign, Robert Klein; its current president, Maria Millan; its current chairman, Jonathan Thomas, and former president, Randy Mills, who introduced CIRM 2.0 and who is now president of the Sanford Burnham Prebys Medical Discovery Institute in La Jolla, Ca.

One also cannot forget the CIRM governing board director who early on who looked at the 2004 Proposition 71 governance structure for the agency and called it a "dog's breakfast." 

You can purchase "California's Great Stem Cell Experiment" by clicking on this sentence, which will take you to Amazon.  

Proposition 14: Pros and Cons of Stem Cell Research in California 2020

Editor's note: The author of this piece is Ben Kaplan of Palo Alto, who appeared in a TV ad for the 2004 ballot measure that created the California stem cell agency. I talked with him recently by phone and invited him to submit his thoughts on the latest stem cell ballot measure, Proposition 14. Here is his article. 

 

By Ben Kaplan

Ben Kaplan

My story begins when my twin brother Ollie and I were born ten weeks prematurely. Despite his early birth and low birth weight, Ollie never had any lasting health problems, but I did. Just five days after my birth, I had a brain hemorrhage, or stroke, which caused cerebral palsy, specifically “left hemiplegia,” or weakness and paralysis on the left side of my body. I have been a supporter of stem cell research and regenerative medicine for over 20 years, with the hope it may lead to new treatment for my condition. During this time, I have seen research make great strides, from initially being conducted mostly in laboratory studies, to its application in human clinical trials.

California has been a trailblazer in state ballot initiatives for over 40 years. These have set national trends for issues and are often copied or emulated by other states: Prop 13 (property taxation), Prop 187 (Immigration), 209 (Affirmative Action) 215 (medical cannabis), 227 (bilingual education), etc. Proposition 71 in 2004 did this for stem cell research by establishing the California Institute for Regenerative Medicine (CIRM). Since then, several other states have passed their own ballot initiatives or legislation to fund stem cell research. This has created new momentum for increased federal funding.

Another benefit of CIRM funding is the development of private and philanthropic partnerships. The demonstration of a commitment by California to fund and support research and laboratory construction has led private foundations and other donors to contribute funds, dramatically accelerating the pace of stem cell research. The investment in research following the passage of Prop 71 also attracted researchers, scientists and private companies to California, providing financial incentives to open offices and laboratories in the state. In addition, CIRM created a research infrastructure for California by developing a system to award grants and share research data and results, giving it a major advantage over other states, and some countries. These partnerships are important because embryonic stem cell research cannot always be conducted in facilities built using federal funds due to pro-life and taxpayer groups, who have raised ethical and fiscal concerns about using public funding for research on embryonic tissue. CIRM research centers are a way around this roadblock by increasing scientific freedom, promoting research collaboration and hastening the development of new therapies and treatments.

In addition, CIRM has created economic expansion, providing a major boost to the burgeoning field of regenerative medicine. Progress in research funded by CIRM has led to a growing body of scientific evidence that treatments from stem cells may be available to people with debilitating and life-threatening conditions in the near future.

Stem cell research funding is on the ballot in California in 2020 as Proposition 14. This proposition has both potential benefits and drawbacks. One argument in favor is that it will continue and enhance California’s leadership position in support of stem cell research. It can also boost the state’s economy. Treatments may lower healthcare costs and improve health, which may lead to increased employment, worker productivity and economic growth. While the long-term outcome of stem cell research remains uncertain, new discoveries are producing evidence that is leading to clinical trials, allowing treatments to move closer to realization.

However, the COVID19 outbreak has also made Proposition 14’s fate uncertain. While stem cell research may lead to new treatments, it has placed unanticipated stress on California’s budget. However, new research is demonstrating the potential application of stem cells as a possible treatment for the virus. Given this pandemic, how will Proposition 14 fare? While the ultimate outcome is yet to be determined, it may depend on a delicate balance between potential treatment outcomes in the future versus expenses for the COVID19 pandemic in the present.

Recently, physicians at Stanford University, in a clinical trial partially funded by CIRM, have found that neural stem cells injected in rats with a condition similar to CP will travel to the damaged part of the brain and repair it. A clinical trial is also currently in progress at the Mayo Clinic using neural stem cells derived from bone marrow to treat hemorrhagic stroke. Private companies are pursuing similar research, with an eye to developing new therapies and treatments.

As stem cell science progresses and it becomes possible to implant stem cells into the brain, it is possible that I could have improved mobility in my left hand and foot, balance and coordination. This would enable me to do so many things that are now challenging, if not impossible, and would greatly improve and enhance my quality of life and that of many others.

Today's Marching Orders from the California Campaign for $5.5 Billion for Stem Cell Research

 

A clip from an email pitch by the campaign for Proposition 14

Backers of the $5.5 billion ballot measure to save the California stem cell agency from its financial demise
are working hard to keep their troops on track to build support for Proposition 14.

Today the campaign sent out a pitch (see above) as part of its social media drive to win approval of Proposition 14 in the Nov. 3 election. And it couldn't be more timely. Twenty-million voters are already beginning to receive their mail-in ballots.

The directions are explicit and amount to a daily list of tasks for patient advocates and others who have signed up for information from the campaign. The sign-up request is on the home page of the campaign website and impossible to miss. 

"Join now. Be part of the movement," declares the website. 

Social media is a bit of a loose term, but it includes such things as Twitter, Facebook and blogging. Research shows that about two-thirds of U.S. adults get news from social media sites. "One-in-five get news there often," says the Pew Research Center. 

"Facebook is still far and away the site Americans most commonly use for news, with little change since 2017. About four-in-ten Americans (43%) get news on Facebook. The next most commonly used site for news is YouTube, with 21% getting news there, followed by Twitter at 12%. Smaller portions of Americans (8% or fewer) get news from other social networks like Instagram, LinkedIn or Snapchat," says Pew.

News consumption is only part of the picture for a campaign. What may be more important is the personal connection that supporters can bring via social media. It is a question of trust and who do you listen to. Someone that you are connected to via social media and know even slightly may appear more trustworthy than the professional purveyors of information. 

So far the mainstream media is covering Proposition 14 lightly, a trend that is likely to continue. The presidential campaign consumes most of the traditional news space. State issues are receiving only minor attention, and Proposition 14 even less. That could be good for its chances of passage, but it is hard to tell in this very unusual political year. Under any circumstance, it remains imperative for the campaign to turn out its supporters in large numbers, which is a key goal for the social media effort. 

Los Angeles Times Opposes $5.5 Billion Stem Cell Ballot Measure, Says State Has Higher Priorities

California's largest circulation newspaper, the Los Angeles Times, this morning editorialized against Proposition 14, the $5.5 billion stem cell measure on this fall's ballot, declaring that the state has "other, more urgent spending priorities."

The Times said,

"Now is not the time for a huge new investment in specialized medical research. First, it makes sense to wait until after the election; if Democrats do well, there should be growing support for embryonic stem-cell research at the federal level, which is where such funding should take place. 

"The future of California’s pandemic-battered economy and budget remains to be seen. Waiting also would give voters a chance to find out how well the state’s stem-cell research projects continue without state dollars, and whether some of the promising advances lead to breakthrough therapies and a return on California’s investment."

The Times claims a daily readership of 1.3 million and a combined print and online local weekly audience of 4.6 million.

The Times is the fifth daily newspaper to oppose Proposition 14. The initiative would save the California Institute of Regenerative Medicine (CIRM), as the agency is formally known, from financial extinction. It is running out of the $3 billion it was provided with in 2004 and will begin closing its doors this winter without a major infusion of cash.  

The Times editorial discussed Proposition 14 and the history of the agency in some detail and the role of its sponsor, Robert Klein, a Palo Alto real estate developer. 

Klein sponsored and was responsible for the drafting of Proposition 14 and the ballot initiative that created the stem cell agency in 2004, He ran the campaign then and is doing so again this year. He was the first chairman of the CIRM governing board and served for 6 1/2 years. He also contributed millions of dollars to both ballot measure campaigns. 

The Times wrote, 

"Klein’s role and the bloated structure of CIRM’s super-sized governing board have given rise to some serious ethical mishaps, including a board member who improperly intervened to try to get funding for his organization. (He is no longer on the board.) After this and several other examples of impropriety, rules were tightened. Board members must recuse themselves from votes when there is a conflict of interest, but with 29 members who all want certain projects to receive funding, there is too much potential for mutual back-scratching. Instead of repairing this problem, the new proposition would expand CIRM’s board to 35 members and retain its troubling independence from oversight by the governor and Legislature, leaving it open to further conflicts of interest.

"Proposition 71 hasn’t yet yielded a significant financial return on investment for the state — or the cures that were ballyhooed at the time. Though no one ever promised quick medical miracles, campaign ads strongly implied they were around the corner if only the funding came through. Proponents oversold the initiatives and voters can’t be blamed if they view this new proposal with skepticism."

The Times noted a number of lingering issues involving the agency, including the size of its 29-member board and the fact that members "generally have ties to the advocacy organizations and research institutions that have received most of the money." (For more on that subject, see here.)

The Times credited CIRM with giving "rise to a burst of scientific discovery." It said that CIRM has supported "promising advances in the treatment of diabetes,  'bubble boy' immune deficiency and vision-robbing retinitis pigmentosa, but other efforts have fallen short in clinical trials." The editorial also said CIRM made "the state the 'it' place for stem-cell research."

Unlike other newspaper editorials, the Times suggested that backers of the agency could come back in a couple of years with a revised, scaled-down proposal that would address issues with the agency.  The agency will still be operating during that period on a minimal level, administering multi-year grants with a skeleton staff.

The Times wrote, 

"There would be an opportunity to rethink and rewrite any future proposals, which should include a far more modest ask of taxpayers as well as fixes to the structure and inflated size of the CIRM board. The institute should also be placed under the same state oversight as other agencies reporting to the governor.

"If CIRM needs money for a basic operating budget over the next couple of years, that could be covered by the state’s general fund. The agency still needs to administer already-funded projects and could use that time to discuss a more affordable path forward. Right now, the state has other, more urgent spending priorities." 

For more on the life and times of the stem cell agency, Klein and issues involving the agency, see David Jensen's new book, "California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures."  Jensen has covered the agency since 2005 and written more than 5,000 items on the subject plus a number of freelance articles for Capitol Weekly, The Sacramento Bee, and other publications.

(Editor's note: Our count of newspaper editorials pro and con shows six with five against and one in support. They include the Times, Chronicle, Bakersfield Californian, San Jose Mercury, Santa Rosa Press Democrat and the Bay Area Reporter. If you know of others, pro and con, please email djensen@californiastemcellreport.com.) 

California Stem Cell Backers Fire Up Major Social Media Effort for $5.5 Billion Proposition 14

Backers of the $5.5 billion measure to save California's stem cell research program launched a major social media effort this week, declaring that they could not afford to compete with "the big money campaigns for significant airtime."

The campaign organization behind Proposition 14, the stem cell ballot initiative, sent out an email pitch recruiting sympathizers to help out via Facebook, Twitter, email, and other Internet avenues. The campaign email went to those on the mailing list of the campaign organization, which likely contains thousands of names.  The numbers could be much, much larger if the campaign is purchasing email lists. 

The campaign email (see below) said, 

"There are only 35 days left before election day, and mail-in ballots are already out in many California counties. We need your help to get the word out about Prop 14 and the fight to save stem cell research, treatments and cures in California! With a crowded election we will need to work hard break through the noise and urge Californians to vote “YES” on Prop 14.

"Leading up to the election, we’ll be sending you sample social media posts, newsletter articles and email blasts – and all we need you to do is share what we send with your channels! We are a patient advocate driven movement, so we don’t have the resources to compete with the big money campaigns for significant airtime, and our path to victory relies on the help of other passionate patient advocates like you. Your efforts will make all the difference, and with mail-in ballots already out it is absolutely critical that this work starts today."

The pitch included canned texts for use in emails to general audiences and non-profit organizations. Canned messages to be used on Facebook and Twitter were provided along with appropriate hashtags for Twitter. A "sample email blast" emphasized that "the federal government  WILL NOT save most of the promising research and therapies in development that would be abandoned if Prop. 14 fails."

Social media campaigns are increasingly important in political and ballot measure campaigns, regardless of whether a campaign can afford traditional TV advertising. Such advertising is less useful in generating support for a number of reasons, including segmentation of media consumption. 

So far, no significant, major opposition has surfaced against Proposition 14.

The campaign for the measure is led by Robert Klein, who sponsored Proposition 14 and is responsible for the writing of the 17,000-word measure. Klein also wrote the 10,000-word, 2004 ballot measure that created the California Institute for Regenerative Medicine (CIRM), as the agency is officially known. Klein is a Palo Alto, Ca., real estate developer.

Klein hired FionaHutton &Associates of Studio City, Ca., to handle the bulk of the campaign work.  

2020-09-29 Proposition 14 California Social Media Email by California Stem Cell Report on Scribd

How Does $5.5 Billion Become Only Five Bucks? A Question Yet to be Answered

Call it California's five-buck, stem cell mystery. It could be a case of Proposition 14  campaign voodoo or just simply a boring calculation, but no one knows -- at least anyone who is willing to talk. 

As readers may recall, Proposition 14 is a $5.5 billion bond measure (plus a lot of other things) aiming at saving the state stem cell agency from financial extinction. The folks behind the ballot initiative, including Robert Klein, the sponsor of the proposal, are telling California voters to never mind that billion-dollar stuff. 

"Proposition 14 will cost the state an average of less than $5 per person, per year – about the cost of a bottle of aspirin," Klein said way back in July.

He may be right. 

However, Klein, who has already put up millions for the measure and heads the campaign, has not explained how he or his team devised the bottle-of-aspirin figure. The California Stem Cell Report has asked the campaign more than once to explain the figure, most recently just last Wednesday. But so far no explanation has been forthcoming. 

Arriving at such a per capita cost involves a number of assumptions, including population projections over the next 20 to 30 years and interest rates over the same period. Of course, it also should be noted that the five-buck figure is per capita not per taxpayer. That means that taxpayers -- because they now number only about 18 million compared to the total population of about 33 million -- will be paying perhaps twice what the campaign claims. 

Some might say this is no big deal, and they may be right. But a substantial number of persons could believe that this black-box, five-buck number is real because it has been repeated so often, even though it is unsubstantiated. Certainly, the campaign hopes that it will be effective and move a fair amount of voters into the "yes" column.

At this point, the five bucks is no more than campaign voodoo. But, as the California Stem Cell Report wrote in July, such is to be expected in any ballot campaign. The object is to win. Campaigns can be expected to embellish, push the envelope and release information that may not stand up to real scrutiny. 

As mentioned earlier, the California Stem Cell Report has not received a breakdown from the campaign about how it devised its five-buck figure.  If an explanation comes in, we will carry it verbatim. Meantime, the five-buck countdown stands at 27 days since the first inquiry was made. Readers should stay tuned. 

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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.

San Francisco Chronicle Says No to $5.5 Billion Stem Cell Measure, Proposition 14.

The San Francisco Chronicle today urged its readers to reject the state ballot measure, Proposition 14, that would stave off the demise of California's stem cell agency with a $5.5 billion infusion of cash. 

The Chronicle's headline on its editorial said, 

"No on Prop. 14; no need to replicate California’s disappointing stem cell experiment"

The editorial cited the Chronicle series in 2018 assessing the work of the agency. Written by Erin Allday,  the news story said,

 “Promised breakthroughs used to sell Proposition 71 in 2004 aren’t panning out, a Chronicle investigation found."

The Chronicle is the largest circulation newspaper to editorialize on the Proposition 14. The Chronicle says it has 173,514 daily circulation, mostly in the San Francisco Bay Area, and 306,525 digital circulation. Readership figures for its editorials are not available. 

The impact of newspaper editorials in state ballot measure campaigns is debatable. In the heyday of the newspaper business, editorial page readership was in the neighborhood of 25 percent or less of total readers.  

Here are some excerpts from this week's editorial. (The editorial department operates separately from the news department, which produced the 2018 investigation.)

"Especially in a field as nascent as stem cells, science is slow, incremental and unpredictable, largely incompatible with the leaps forward touted in 2004. While the unique state of the science and politics drew broad support for Prop. 71 — including The Chronicle’s — we shouldn’t make a habit of setting science policy and budgets by state plebiscite."

"While state funds helped support the research that led to two approved cancer drugs and a host of prospective therapies in various stages of development, far-reaching breakthroughs attributed to the stem cell agency have been scarce so far, as a Chronicle investigation found. More than half the original funding went to buildings and other infrastructure, education and training, and the sort of basic research that, while scientifically valuable, is a long way from medical application. There’s nothing inherently wrong with that, but it is at odds with the vision of dramatic advancements put to voters."

"While both initiatives provide for recovering income from approved therapies, the fiscal benefits are a matter of speculation. And with the pandemic, wildfires and more stretching the state’s resources, stem cell research looks like an even more unlikely gamble for a government with more pressing priorities."

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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.