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.

*****

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.'"

********

​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).