'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