The $5.5 Billion Stem Cell Proposition: A "Christmas Tree" Measure Loaded With More Than Cash

 Editor's note: The following item was written by the producer of the California Stem Cell Report and was the most-read article carried by the Capitol Weekly online news service in 2020, where it first appeared. 

By David Jensen

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

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

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

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

It creates a building program for treatment centers that could total about $82.5 million. They would be located in areas not now well-served. And the measure locks up $1.5 billion for “diseases and conditions of the brain and central nervous system,” such as autism and schizophrenia. 

Approved by voters in 2004, the agency is already a prodigiously ambitious effort, seeking stem cell cures and treatment for afflictions that backers say burden half the families in California. However, the original $3 billion that voters provided is dribbling to an end. Unless voters provide $5.5 billion more, the agency — known officially as the California Institute for Regenerative Medicine (CIRM) — will begin shutting its doors this winter. 

While Proposition 14 is the cure for what financially ails the agency, the measure also sends CIRM into arenas that some would argue muddle its focus and distract from its original goals.

(Click here to see the Legislative Analyst’s description of the measure, which is going to nearly 21 million California voters )

Details of the changes in CIRM’s mission are tucked away in the complex and murky, 10,000-word initiative sponsored by Robert Klein, a Palo Alto real estate developer and attorney. He oversaw the writing of the initiative as well as the 2004 stem cell measure that created the agency. Klein was the first chairman of the agency and is now leading the current campaign.

The new playing field for CIRM encompasses particularly critical areas of costs to patients and profits for companies. Stem cell therapies are expected to be enormously expensive — $1 million or more in many cases. That’s a figure that makes health insurance companies balk and Medicare blanch.

Proposition 14  would launch a hefty effort to make stem cell therapies more affordable and accessible. The cash behind that drive could run as high as $155 million. And that’s not necessarily going for patients.

The intent is to create and build support for financial models for health insurance companies. CIRM would also be charged with helping to implement them. Such models would justify the cost of the theoretically one-time cures by demonstrating that they would actually save money — ending the need to treat patients in what currently seems to be an endless and expensive cycle.

Proposition 14 speaks of covering patients and, importantly,  their caregivers for medical expenses, lodging, meals and travel. That would help provide access to clinical trials that are located in prohibitively expensive urban areas, which poses financial barriers for persons who live some distance away. The added coverage would additionally help researchers and companies recruit enough trial participants, which can be a problem in some disease areas.

Proposition 14 creates a 17-member, CIRM affordability committee to drive all this. It would work with industry and the federal government to win their support.  The committee would be backed with as many as 15 CIRM staffers. The ballot allows as much as $55 million for their compensation over 10 or so years. 

But if 15 is not enough, more employees could be hired beyond the nominal cap on CIRM employees of 70 if they are compensated through the use of private cash.

The extraordinary cost of stem cell treatments involves something called “reimbursement,” a biomedical industry euphemism for how companies cover the high costs of the research and still make a profit. If money is not to be made, businesses are not likely to be motivated to turn CIRM research into cures.

The measure additionally allows the new affordability panel to hire consultants, capping that expense at about $105 million.

The affordability effort involves important public policy, industry and research issues that concern patient groups and industry. However, the affordability panel would be permitted to operate behind closed doors as it considers the problems and weighs the solutions.

Votes by the committee, however, would have to be taken in public.

Members of the panel would not be required to disclose publicly their economic or professional interests. The committee would be exempt from the state public records act except for material specifically submitted to the CIRM board.

Proposition 14 locks up $1.5 billion for “diseases and conditions of the brain and central nervous system, such as Alzheimer’s disease, Parkinson’s disease, stroke, dementia, epilepsy, depression, brain cancer, schizophrenia (and) autism.”  The $1.5 billion would not be available for research into the No. 1 killer in the United States, heart disease, or other excluded conditions. 

Beyond the affordability program, Proposition 14 gives CIRM new authority to finance research in several additional fields. The authorization is scattered throughout the initiative document. Mental health research first appears on page nine. Depression appears on page 26. Therapy delivery, which is not defined in the measure, crops up in 10 locations. Personalized medicine and “aging as a pathology” surface on page 34.

On a much smaller scale, but important to researchers, the proposition includes up to $27.5 million for a shared labs program that was scrubbed a few years back when CIRM turned more towards clinical trials. And the initiative opens the door to even more programs that are not specifically mentioned. It gives a high priority to supporting pluripotent stem cell research that is unlikely to receive federal funding or where funding is “not timely or sufficient.”

Perhaps the biggest, but not entirely new opportunity for CIRM to expand beyond stem cell research involves “vital research opportunities.”  CIRM calls them VROs. And they are a loophole that allows CIRM to finance almost any kind of research if there are enough votes on the board to do so.

In both the original and current initiative, a  VRO is defined as “scientific and medical research and technologies” that provide “a substantially superior research opportunity, vital to advance medical science.”

Proposition 14 makes it easier for the CIRM board to declare a VRO. Currently, it takes a two-thirds vote of a quorum of the group that reviews applications. Under this year’s ballot measure, CIRM does not need to meet those criteria. The governing board could invoke a VRO on its own. In some cases, it could require only 12 votes or less of the 35-member board, depending on the quorum and the number of board members present.

Proposition 14 specifically added the fields of  “genetics, personalized medicine, and aging as a patholoqy” to VROs. In the 2004 initiative, the phrase “vital research opportunities”  appeared only seven times. In this year’s initiative, it appears 17 times as the possibility of its use has expanded. Significantly, experience involving vital research opportunities is now listed as part of the qualifications for the chair, two board members and 15 members of the group that reviews grant applications.

CIRM has invoked the original VRO clause only twice. A third attempt was rejected last May after directors expressed concern about mission creep. However, Klein’s new emphasis on it points to the likelihood of increased use, especially if he once again becomes chairman of CIRM.

Under existing law, CIRM’s royalties go into the state’s general fund, the source of state expenditures for prisons, schools and health services. Under Proposition 14, the royalties would still go into the general fund, but they would be locked up for use in dealing with affordability. In 2004, the stem cell campaign financed studies that envisioned royalties of as much as $1.1 billion. To date, they have totaled only $462,433. However, it can take years for a scientific discovery to work its way into an actual product. And a particular discovery may well amount to only a tiny contribution to a product, which would reduce the likelihood of major royalties.

In another major move, Proposition 14 would benefit some of the less-than-urban areas of the state in a new “geographic diversity” program. Rural or semi-rural areas suffer from a lack of physicians as well as the high tech facilities needed to make stem cell treatments available for participation in clinical trials. The measure earmarks as much as $82.5 million for new “community centers of excellence.” They would “support clinical trials and…serve as the foundation for the delivery of future treatments,” the proposition states, giving priority to “geographic distribution.”

One of them could well be in Fresno where the University of California, San Francisco (UCSF), has established an outpost. One of the new members on the CIRM board would be from the UCSF operation in Fresno, making it the only institution that has two representatives on the board. Another new member of the board would be from UC Riverside, whose medical school is only seven years old. UC Riverside also serves a community that incorporates large rural and semi-rural areas.

The increase in the size of the board to 35 flies in the face of recommendations by the prestigious Institute of Medicine (IOM). Among other things, it said in 2012 that the current 29 board members are more than sufficient for the agency. CIRM paid $700,000 for the IOM study, which it hoped would help generate voter support for more funding.

If Proposition 14 passes, the measure creates a relatively quick way to begin to overhaul the board. Under the measure, a number of current members of the board could lose their seats if they have served at least half of their terms.

It is not clear whether the CIRM governing board understood the removal provisions when they endorsed Proposition 14 June 26 on a 21-1 vote. The discussion lasted only 30 minutes. “It’s a no-brainer,” said George Blumenthal, chancellor of the UC Santa Cruz campus and a member of the CIRM board..

Proposition 14 is something of a “Christmas Tree” measure — a term used to describe legislation that has something for everyone. Many ballot initiatives are like that. They must run the gauntlet of a ballot campaign, luring millions of voters into voting for them. Backers of initiatives need to satisfy potential donors and potential beneficiaries, all the while not alienating anybody enough to generate well-funded, powerful opposition.   

The 2004 measure fulfilled those needs nicely. Nearly every institution that stood to benefit from CIRM funding gained a seat at the table where the decisions were made — for better or worse. 

Proposition 14 carries on in that tradition and expands it. Plus the initiative attempts to deal with the tough challenges of costs and profits in what many expect to be a revolution in medicine. Voters will begin casting their ballots in early October. Backers of the initiative have only five weeks to catch the early birds in that particular flock.
—
Editor’s Note: David Jensen is a retired newsman who has followed the affairs of the $3 billion California stem cell agency since 2005 via his blog, the California Stem Cell Report. He has published more than 5,000 items on California stem cell matters.

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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.

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It was a draft that was inadvertently published. 

Grand Goals and Record Speed; Hype and Human Biology

 An ad from 2004 ballot campaign that created the California stem cell agency. 

An article in the Los Angeles Times today took on scientific research and "grand goals and grander ambitions, all to be achieved with record speed."

The piece was written by Pulitzer Prize-winning Times columnist and author Michael Hiltzik. He was not writing about the California stem cell program. 

But, as readers know, the stem cell agency hopes voters will approve a $5.5 billion bond measure this fall to allow it to continue its own ambitious pursuit of stem cell cures. 

Hiltzik, author of "Big Science" and the just-published "Iron Empires," wrote about the Trump Administration and its "warp speed" therapies for Covid-19. But he also mentioned the Golden State's stem cell effort. Here is the text of what Hiltzik had to say:

"Hype has become an inextricable part of science because it can generate millions of dollars of support. Consider the 2004 campaign to pass Proposition 71, which created the $3-billion California stem cell program (known formally as the California Institute for Regenerative Medicine, or CIRM).

"As I’ve reported before, the measure 'was sold to a gullible public via candy-coated images of Christopher Reeve walking again and Michael J. Fox cured of Parkinson’s.'

"The hype got the proposition passed, but CIRM has struggled ever since to live up to promises that it has been unable to deliver. That could be a burden this election season, when CIRM is seeking an additional $5.5 billion from voters and will have to explain why all the cures it predicted haven’t materialized. 

"'That still might be a worthwhile public investment,' (Leigh) Turner (of the University of Minnesota) observes, adding that the research actually funded by CIRM has been conducted along responsible scientific lines. 'But you have this disconnect between what’s used to float the entire enterprise, and what the actual results are.'"

Turner, who is a bioethicist, was also quoted as saying, 

“In human biology often as you proceed with your research, as you think you’re getting closer and closer to the finish line, you begin to discover it’s more and more distant. You become increasingly aware of the complexity you’re dealing with.”

California Governor and Proposition 14: Will He Endorse Prop. 14?

California Gov. Gavin Newsom today endorsed three of the measures on the fall ballot but skipped over Proposition 14, the $5.5 billion stem cell bond measure. The move does not necessarily mean he will not take a position, however. 

Newsom was a big supporter of the stem cell agency in 2004 and 2005. When he was mayor of San Francisco, he helped to put together a $17 million package that lured the agency, formally known as the California Institute for Regenerative Medicine (CIRM), to San Francisco. 

When the free rent deal expired, CIRM switched its headquarters to Oakland because of the costs of renting office space in San Francisco. 

It is a good political move to delay an endorsement until next month when the news is less likely to be filled with stories about fire, presidential conventions and Covid 19.  But the endorsement -- if there is one -- should come at least a couple of weeks before voting begins in early October. 

Of course, if Newsom is seriously out of public favor by that time, an endorsement may not help Proposition 14. 

Correction

A item published Oct. 24, 2020, dealing with a UC Irvine panel discussion of Proposition 14 incorrectly said that the event would be Oct. 5. It will be on Oct. 6.  

Beating the Stem Cell Drum: The Quest for $5.5 Billion More

Four significant events are coming up this fall that offer golden opportunities to draw attention to the $5.5 billion ballot measure that would financially revive the California stem cell agency and send it along a new and more expansive road. 

The measure is Proposition 14, sponsored by Robert Klein, the Palo Alto, Ca., real estate developer and attorney who was the first chairman of the California Institute for Regenerative Medicine(CIRM). He crafted the proposal and is leading the campaign.

The measure would provide $5.5 billion more for CIRM at a total estimated cost of $7.8  billion, which includes the interest on the state bonds. The agency was funded with $3 billion in 2004, which will run out this year. In addition to providing more cash, Proposition 14 would make major changes in CIRM itself. (See here for full text.)

August is a bit of a sleepy month for public attention to state ballot initiatives, although much campaign work has long been underway behind the scenes. After Labor Day, activities will step up, especially this year. All of California's 20 million voters will be getting ballots in the mail and can begin voting in early October. There will be no waiting until Nov. 3. 

The Democratic presidential campaign is also urging early voting, which is likely to trigger higher than normal ballot returns in October. So voters need to be persuaded early. 

The online events coming up create an opportunity for voters to learn more about the stem cell agency and its accomplishments. They also create a first-class springboard for generating coverage in the media about the agency. Opponents, as well, could use them to mount their own stories. 

Here are the events that are known so far. More may be coming. If you know of others, please send an email to djensen@californiastemcellreport.com

CIRM's grantee meeting, Sept. 14-15 -- Sponsored by CIRM and which will bring together grantees for an exploration of the work financed by the agency.  Speakers include Maria Millan, CEO of CIRM, researcher Irv Weissman of Stanford and Larry Goldstein of UC San Diego. 

CIRM's Alpha Clinic Symposium, Oct. 8 -- Sponsored by UC Davis, site of one of the clinics, which specialize in delivering stem cell therapies. CIRM kicked off the Alpha network with $50 million.  Topics will include a look at CIRM's $5 million Covid effort, which includes involvement in two clinical trials. Register here. 

UC Irvine panel, Oct. 6, sponsored by UC Irvine. This event is focused sharply on Proposition 14. It is still being organized but expects to feature researchers, opponents and media. We will post more details as they become available. 

Cell and Gene Meeting on the Mesa, Oct. 12-16 -- Organized by the Alliance for Regenerative Medicine, this is an industry event that requires fees.  It has attracted as many 1,200 persons in the past and has a robust preliminary agenda that digs into the future of cell therapies.  The event was previously staged in La Jolla, Ca., but is now online. 

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

(Editor's note: An earlier version of this item incorrectly said that the Irvine panel was Oct. 5.) 

Death of Patient Halts Clinical Trial That Involved California Stem Cell Agency

A clinical trial based on a $4 million award from the California stem cell agency has been suspended after one of the patients died.

The phase one safety trial was being conducted by Poseida Therapuetics, Inc., of San Diego.  In 2018, Poseida received $4 million for the proposed therapy from the California Institute for Regenerative Medicine (CIRM), as the stem cell agency is officially known. 

Clinical trials are the last stage before a treatment is approved by the federal government for widespread use. 

The death of the patient comes as CIRM supporters are backing a measure, Proposition 14, on the November ballot that would provide $5.5 billion more for the agency. 

CIRM is running out of the $3 billion provided in 2004, when it was created via a ballot initiative. It will begin closing its doors this fall without additional funding.

In response to a request for comment, the agency released the following statement:

"Our sympathy goes out to the family of the individual who died and to the team at Poseida. We know how deeply committed they are to the work they are doing and how big an impact moments like this have on researchers.

"We did fund the late stage pre-clinical research, but as we are not involved in this clinical trial itself we have no additional information. The (Food and Drug Administration) has put a hold on the trial to determine what happened and we will continue to follow the results of this matter very closely."

CIRM said in a 2018 news release that the proposed treatment was an effort to "supercharge a patient’s own immune system cells to attack and kill a treatment-resistant form of prostate cancer."

Maria Millan, CEO and president of CIRM, said in the news release:

“This is a promising approach to an incurable disease where patients have few options.

"The use of chimeric antigen receptor engineered T cells has led to impressive results in blood malignancies and a natural extension of this promising approach is to tackle currently untreatable solid malignancies, such as castrate resistant metastatic prostate cancer.

The $4 million was for work that immediately preceded the trial -- not the trial itself -- and led to the preparation of an Investigation New Drug (IND) program.  

On Feb. 28 of this year, Poseida initiated the phase one trial, which is aimed at determining the safety of the proposed treatment, according to documents filed with the federal government. The company hoped to enroll 40 patients. 

In a filing yesterday with the Security and Exchange Commission, Poseida said that the Food and Drug Administration had placed the trial on "clinical hold."

The company said, 

"Although the direct cause of the hepatic failure has not yet been confirmed, the patient developed symptoms consistent with macrophage activation syndrome (MAS). MAS is a serious and potentially fatal overactivation of the immune system which has been associated with CAR-T therapies, but can have other causes such as infection and autoimmune disease. 

"The patient also developed blurred vision which was diagnosed as uveitis. The clinical investigator has assessed the SAE (serious adverse event) as possibly related to P-PSMA-101 pending further investigation."

P-PSMA-101 is the name of the therapy involved. 

CIRM's summary of the review of Poseida's application (CLIN1-10999) in 2018 said the proposed therapy "had the potential to improve survival in this patient group, which faces a poor and fatal prognosis." 

It also said, 

"Some reviewers noted the potential for off-target toxicity with a PSMA CAR-T product, which should be carefully assessed in the clinical studies."

Here is the text of the discussion at the CIRM meeting at which the grant was approved. 

Poseida's stock price plummeted on the news. It closed yesterday $13.00 a share. As of this writing, it was trading at $9.01. 

Just this July, Poseida went public and has traded as high as $17.62. Prior to the stock offering, Novartis invested $142 million in the firm. The public offering valued the company at $1 billion.

CIRM has also backed Poseida with $20 million for a clinical trial involving a different approach for a disease called multiple myeloma. 

(Editor's note: An earlier version of this item did not carry the comment from CIRM, which came after the item was posted. Also added was the link to the CIRM discussion of the award in 2018.)

Text of CIRM Consideration of $4 Million Award to Poseida Therapeutics

Here is the text of the presentation of the application (CLIN1-10999) from Poseida Therapeutics, Inc., to directors of the California stem cell agency.

The presentation was made by Shyam Patel, associate director for portfolio development and review at the stem cell agency. The directors did not discuss the application and gave it the go-ahead July 19, 2018,on a 14-0 vote. 

The application was approved sometime prior to that date by the agency’s grant reviewers in a closed-door session, as is the practice for handling all applications. The agency’s governing board routinely rubber stamps the decisions of reviewers in virtually all cases.

The grant was designed to fund work leading up to the trial in question. The award was closed before the trial began.  

Here is what Patel had to say, based on the CIRM transcript of the meeting.

“This is a late stage preclinical therapy study for a therapy for prostate cancer. The therapy itself is CAR-T cells, and these are stem memory T cells that compose this particular product. 

"The indication is for patients with metastatic castrate resistant prostate cancer. This is the most advanced form of this particular disease. The goal for this particular project is to conduct product manufacturing, conduct the preclinical safety and efficacy studies, as well as prepare and submit the IND. And they're requesting roughly $4 million for CIRM funding, and they're going to be co-funding $1 million.

"To give you an idea about this particular project, we've prepared a few items. First of all, the potential impact for this therapy. There are 165,000 new cases of prostate cancer submitted for this particular year, and roughly 30,000 prostate cancer deaths for 2018 as estimated by the NIH. 

"Now, the particular disease indication that this product is going for, which is the metastatic castrate resistant prostate cancer population, that represents a very small percentage of the overall prostate cancer population, but an overwhelming majority of the deaths for this particular disease. If successful, this particular therapy would target that most needy, highest risk patient population. 

"In terms of the value proposition, over the last decade or so, there has been a steady improvement in the standard of care for prostate cancer. Currently available therapies for prostate cancer for metastatic castrate resistant prostate cancer includes hormone therapy, chemotherapy, as well as an autologous T-cell product, which is an activated T-cell product, all of which have shown modest survival benefit in clinical trials. 

"The proposed therapy has a potential to induce long-term remission with possibly a single treatment. In terms of why this is a stem cell project, as I mentioned earlier, this particular product is composed of memory stem T-cells. 

"To give you a brief overview of the current portfolio for CIRM with respect to related projects, we are not currently funding any prostate cancer-directed projects, but we do have some solid tumor projects, including therapies including therapies of cell-derived therapies as well as small molecule antibody-based therapies, all in early phase or IND-enabling studies. This particular applicant has received CIRM funding before.

"They are currently conducting a phase 1 trial for a CAR-T based therapy for multiple myeloma, which is funded by CIRM. Lastly, the GWG (grant review group)  reviewed this application and unanimously gave it a tier one recommendation. There were 12 scores for tier one, zero scores for tier two, and zero scores for tier three. The CIRM team recommendation follows the GWG recommendation for the award amount of $3,992,090."

Tough Editorial Calls for Rejection of $5.5 Billion Stem Cell Measure; Therapies Have not Materialized

 A hard-hitting editorial this morning ripped this fall's $5.5 billion ballot measure to refinance the California stem cell agency, declaring that the proposal was unnecessary and "out of the question."

The article appeared online in the the San Jose Mercury News and the East Bay Times in the San Francisco Bay Area. It declared: 

"Long-term, sustained funding was never the intent when California voters passed Proposition 71 in 2004, authorizing the state issuance of $3 billion of bonds for stem-cell research....

"It’s time for California’s stem-cell agency to continue its work as a self-sustaining non-profit or close down and allow federal grants and private business to push the industry forward."

The editorial on Proposition 14 was the toughest of the four that have surfaced so far, going point by point through expectations aroused by the campaign of 2004 and CIRM's performance since then. 

On the state vs. federal research, the editorial said,

"Finding therapies for devastating diseases such as Alzheimer’s, Parkinson’s and diabetes should be primarily the federal government’s responsibility."

On theoretical cost savings running as high as $1.1 trillion, it said,

"If those eye-popping, speculative estimates sound familiar, they should. Prop. 14 supporters made similar suggestions in 2004. But 16 years later the savings and life-saving therapies have not materialized."

On financial returns to the state, the editorial said, 

"In 2004, overzealous promoters of Prop. 71 said the state could expect as much as $1.1 billion in royalties from stem-cell research within 35 years. But, so far, the independent Legislative Analyst Office’s reports the state’s stem-cell efforts have provided just $350,000 in royalties."

On conflicts of interest, it said, 

"Prop. 14 does little to eliminate that ethical issue. If anything, it makes it worse by adding an additional six members to its board without substantially altering the selection criteria. Don’t look for elected state officials to provide the needed oversight. Prop. 14 prevents the Legislature from making any amendments to the law without a 70% vote of approval from both the state Senate and Assembly."

The editorial concluded, 

"California’s stem-cell research effort does not merit another $5.5 billion investment of state taxpayer funds. Vote no on Prop. 14."

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

 

Fresh Media Endorsements of Proposition 14: Two Against, One in Favor

Two more media outlets this week took positions on Proposition 14, the $5.5 billion ballot initiative that would save the California stem cell agency from financial extinction. 

One outlet recommended approval. The other did not. 

The Orange County Register came down on the negative side. It declared, 

"For one thing, times have changed and the original rationale — California doing what the feds wouldn’t — is no longer applicable. For another, private enterprise has taken a bigger interest and stepped up research in this field. 

For another, Prop. 14 doesn’t resolve a longstanding lack of oversight and accountability. And finally, imposing new costs on residents is hardly merited when most are struggling....Stem cell research will go on, CIRM or no CIRM. No on Prop. 14."

The editorial did not mention that UC Irvine, which is in its circulation area, has received $125 million from the agency. 

The Bay Area Reporter, which serves the San Francisco area LBGTQ community, said, 

"Continuing medical research is vital. While CIRM board member Jeff Sheehy, a gay man who's a former San Francisco supervisor, has been quoted as saying he is 'troubled' by the proposal because he thinks it might oversell potential benefits of stem cell research, Robert Klein, the real estate investment banker who spearheaded the 2004 initiative, has created an accessibility and affordability working group. The state needs to continue this research."

News media positions on the measure now total three. The Bakersfield Californian is the third. It is recommending a no vote. 

(CIRM, of course, is the anacronym for the official name of the stem cell agency.)

Need Money? California Stem Cell Agency Offering Cash for Clinical Stage Proposals

 Want to be one of the last researchers in the Golden State to get cash from the $3 billion California stem cell agency?

That's a possibility if you act before Aug. 31. The agency has reopened its clinical trial stage round and has issued a special call for proposals.  The agency is running out of money and is hoping that voters will provide $5.5 billion more by approving Proposition 14 on the fall ballot. 

But it has enough left that to be able to finance two proposals in this area. The agency said in an announcement, 

"The objective of this program announcement is to create a highly competitive partnering opportunity to accelerate the completion of a clinical trial for a promising stem or progenitor cell-based treatment that addresses an unmet medical need. 

"Under this program, CIRM will act not only as a funding agency, but will also devote significant internal resources and leverage its external team of world-class subject matter experts to actively advance the project. The result of a successful application will be the formation of a true partnership that both accelerates the program and gives it the greatest opportunity for success."

For more information see here. 

Voting on Life or Death for California Stem Cell Agency Begins in October -- Not November

Don't be fooled by the talk about an election in November. Voting on the $5.5 billion stem cell bond measure, Proposition 14, actually begins early in October -- not Nov. 3. 

That is a critical fact of life for the campaign on behalf of the measure. With voting starting in October, backers and opponents will have to persuade voters early.  Late October or Nov. 3 will be too late to capture the votes of millions. 

It is not as if the folks in the mainstream media are trying to deceive when they refer to the November date. The first Tuesday in November has long been a traditional election day in presidential races. But it is the final day for voting -- not the only one -- something that is well known to political professionals. 

It is especially important this year because all 20 million or so registered voters in California are scheduled to receive their ballots by mail -- not just those who have previously signed up for absentee ballots. 

That means that many voters will be casting their ballots in less than two short months -- not three -- and making their decisions on whether the California stem cell agency should live or die. The agency is running out of its original $3 billion and will begin closing its doors this fall if Proposition 14 fails. 

Quote of the Day

 “I realized early on that when you deal in the heady company of presidents, cabinet secretaries and members of Congress and are asked for advice, you must be prepared to disappoint people with the truth and risk never getting asked back into the inner circle. I accepted that concept. Science is truth, and as a scientist I told the truth.” -- Anthony Fauci, in a speech accepting 2007 Lasker Award, as quoted by UC Davis medical student Samantha Wong in her prize-winning essay, "Science as a Voice of Reason."

Stem Cell Perseverance in California: CIRM Tells Its Jam-Packed Story

A page from CIRM's annual report, which says that the girl is alive today
as a result of a clinical trial at UCLA that CIRM helped to finance.

The California stem cell agency, which is facing financial extinction, this week unveiled its latest annual report, which is a paean to its work and indirectly a pitch to California voters to refinance it with $5.5 billion. 

In an item yesterday on the agency's blog, The Stem Cellar, Kevin McCormack, wrote, 

"This latest CIRM Annual Report covers 2019 through June 30, 2020. Why? Well, as you probably know we are running out of money and could be funding our last new awards by the end of this year. So, we wanted to produce as complete a picture of our achievements as we could – keeping in mind that we might not be around to produce a report next year."

State law requires the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, to produce an annual report, much as publicly traded companies do. State law also forbids the use of taxpayer funds in ballot campaigns. But it does not forbid state agencies from engaging in their normal public information work. 

Dubbed "Perseverance: From Theory to Therapy," the annual report cost $34,000, according to the agency. The document makes a compelling case for adding $5.5 billion to the $3 billion voters provided in 2004 when they created CIRM. 

The multibillion dollar figures, however, do not include the projected interest costs to taxpayers, which bring the total estimated expense to something in the neighborhood of $13 billion. 

The $13 billion is also not mentioned in the annual report from CIRM, which is in keeping with the usual annual report traditions involving both public and private enterprises. They generally do not dwell on information that could be construed as less than upbeat, if at all possible. 

As expected, the report speaks highly of the agency's work, citing the 64 clinical trials in which it is involved. At the same time, a casual reader is likely left with the impression that CIRM financed the total cost of all of those trials, which is not the case. 

In another example of pushing the envelope, the document celebrates a study last fall that said that CIRM had an economic impact of more than $12 billion. CIRM characterized the report as "independent." CIRM actually paid USC, which has received $114 million from CIRM for stem cell research, another $206,000 to prepare the economic report. 

The annual report stated that the agency's efforts had a "significant impact" on the state's economy, which was estimated at $3.2 trillion annually in 2019. Twelve billion is 0.4 percent of that overall figure, something less than significant.  

CIRM's $5 million Covid-19 round is mentioned prominently at the front of the annual report in a move that CIRM hopes will resonate with voters when they are marking their ballots for or against Proposition 14, the stem cell measure. The $5 million is, again, a tiny amount when compared to the billions being spent nationally for Covid research. 

All that is not to say that CIRM has not performed significant work. It definitely has left a major mark on the stem cell field nationally and even globally. Some of the 2,000 people participating in the clinical trials have benefited. The agency has fostered collaboration on stem cell research between institutions that probably would not have occurred without a financial stimulus from CIRM. And it has created a new, speedy, grant-review model that puts research money in the hands of researchers more quickly.  

More can be said, but you can find it all in what perhaps will be the last annual report from an enterprise that is unique in California history and unique in size and scope among all the 50 states.

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