The AP Says Prop. 14 -- the $5.5 Billion California Stem Cell Measure -- Wins Approval

Robert Klein, sponsor of Proposition 14
California Stem Cell Report photo

California voters have bailed out the "nearly broke" state stem cell agency by approving $5.5 billion more for the 16-year-old program, The Associated Press has declared. 

The AP yesterday called the election on Proposition 14 with 51 percent approval of the measure. This morning, state election officials said the figure still stood at 51 percent (8,025,624) with 49 percent against (7,700,870). An estimated 1,054,820 ballots remain to be counted. 

AP reporter John Rodgers  described the agency as "nearly broke." He wrote that the approval was the narrowest margin of any proposition on the ballot. The result was also a far cry from the 59 percent vote for creation of the agency in 2004. 

At the time, the stem cell program was provided with $3 billion, but the money was nearly gone by this year. The agency was scheduled to begin closing its doors this winter without additional funding. 

The campaign of 2004 raised high expectations among voters that miraculous stem cell cures were just around the corner. However, the agency has yet to help finance a stem cell treatment that is widely available to the general public, although it is helping to finance 64 clinical trials. 

CIRM Chairman Jonathan Thomas said in a statement (full text below) that the agency was "thrilled" by the election result which he said showed that the people of California "recognized our historic achievements."

The official sponsor of Proposition 14 is Robert Klein, a Palo Alto real estate developer. He directed the writing of the 17,000-word proposal as well as directing  the campaign and contributing millions of dollars to the effort. Klein served an identical role in 2004 and became the first chairman of the agency as a result of language that he wrote into the 2004 proposition. 

It is unclear what role, if any, Klein will have at the agency in the next several years. Thomas' term is not set to expire until Dec. 13, 2022.

In a statement, Klein said, 

"The success of Propositon 14 sends a clear message from California voters that one of the most important investments our state can make is in the future health of our families." (full text below) 

Ironically, while Proposition 14 provided for $5 billion-plus in "new," borrowed money (state bonds), it does not provide any funding beyond that amount for the California Institute for Regenerative Medicine (CIRM), as the agency is formally known. That means that CIRM will need another bond measure in 10 to 15 years unless it can devise a plan for financial sustainability, a task that it has failed at over the last 16 years. 

Proposition 14 also significantly expands the scope of the research that CIRM can support and increases the much-criticized size of its governing board from 29 to 35. And it provides a mechanism to hire substantially more employees. 

CIRM's staffing peaked at about 56 and stood at 33 at last report. It will need to begin hiring more soon if it is to ramp up its award program to levels of previous years.

The CIRM board is scheduled to meet next month when it may take up revisions in its strategic plan and other forward-looking matters. 

Here is the full statement from Thomas, chairman of the CIRM governing board: 

“We are thrilled to see Proposition 14  approved by the voters of California. We are proud of what we have achieved so far - the cures and therapies we helped develop, the billions we brought into the state in additional investments, and the tens of thousands of jobs we created – and we look forward to continuing that work.

 

"We are honored by the trust the people of California have placed in us, and by the support of our extraordinary patient advocate community and by the many Chambers of Commerce around California who have all recognized our historic achievements.

 

"We are already working on ways to repay that trust and bring stem cell and regenerative therapies to all the people of this great state, particularly for communities that have traditionally been overlooked or underserved.” 

Here is Klein's statement from the campaign website:

“The success of Prop. 14 sends a clear message from California voters that one of the most important investments our state can make is in the future health of our families. Over the past decade, California has made incredibly thoughtful and impactful investments in developing stem cell therapies and cures for diseases and conditions like diabetes, cancer, blindness, Parkinson’s, paralysis and many more; now we know this progress and work to mitigate human suffering, restore health and improve the human condition will continue,” said Robert and Danielle Klein, Chairs of Californians for Stem Cell Research, Treatments and Cures.

“A special thank you to California’s voters and our supporters in passing this critical measure. Today would not have been possible without our historically unprecedented coalition of patient advocate organizations and individuals – the heart and soul of this campaign – who worked tirelessly to overcome all obstacles and help secure a victory for patients and their families, and deliver hope to those searching for a cure for generations to come.”

“YES on Proposition 14 was outspent by a majority of the other measures on the ballot, but from day one, our mission has been too important to give up. Patients and their families looking for cures and treatments for their loved ones do not understand the meaning of impossible, and neither did the YES on Prop. 14 campaign. This measure would not have overcome these challenges without the patient advocacy community that refused to take no for an answer and continued to fight for their loved ones; patient advocates, along with the empathy, foresight and continuing commitment of California voters, have delivered a victory for YES on Proposition 14 and secured funding to improve or save the lives of millions.”

California's $5.5 Billion Stem Cell Campaign and Covid-19: How Science and Politics Marry

Editor's note: The following item written by the producer of the California Stem Cell Report appeared yesterday on the Capitol Weekly online news service. 

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The California stem cell agency has just finished pumping $5.3 million into the fight to save the lives of COVID-19 victims. And — in a ballot-box bonus — its efforts are already surfacing in the ballot campaign to rescue the agency from its own demise.

The agency is running out of money. It will begin closing its doors this fall without major financial support that it hopes will come from Proposition 14, a $5.5 billion bond measure on the November ballot.

The $5.3 million in the fast-track, Covid program is tiny by comparison. But the awards are likely to play a heftier role than might be anticipated based on their size. Stories about the Covid awards have appeared on the campaign website in a move to tap into the deep public concern about the coronavirus.

The Covid research piggybacks on the federal “warp speed” drive to develop Covid treatments and is aimed at demonstrating that the agency is part of what CIRM officials describe as a worldwide, “all-hands-on-deck” effort.

Three clinical trials have been funded, which involve actual patients as opposed to laboratory research. If the trials are successful, patients who have benefited are likely to surface in campaign video advertising aimed at refinancing the agency, formally known as the California Institute for Regenerative Medicine (CIRM).

CIRM sorely needs research results that will resonate with voters. The 2004 ballot campaign that created the $3 billion program raised expectations that stem cell therapies were right around the corner. But the agency has yet to produce a stem cell treatment that is widely available to the public.

The agency launched its Covid round on March 27 when CIRM board chairman Jonathan Thomas declared, “The coronavirus is creating an unprecedented threat to all of us, and, as one of the leading players in regenerative medicine, we are committed to doing all we can to develop the tools and promote the research that will help us respond to that threat.”

Indeed, failure by CIRM to respond to the COVID-19 threat — it could be argued — would be a breach of CIRM’s public responsibilities.CIRM’s Covid research financing is a case where an urgent medical need marries nicely with ballot-box politics. The agency is forbidden by law to campaign for the ballot measure. But its charter also allows it to pursue a wide range of research possibilities.

Late last month, CIRM directors capped off the round by approving two awards and adding nearly $300,000 to the original authorization of $5 million. All of the awards have been made under an emergency process that requires awardees to be ready to begin research within 30 days and achieve “a clear deliverable within six months.”

The final awards went for basic level research. Earlier, CIRM approved funds to assist in the three clinical trials, which are the final stage before a treatment can be approved for widespread public use. The trial awards range from $1 million to $701,000 each, a bargain price for joining a trial. Most of CIRM’s previous clinical trial awards run into many millions.

CIRM now counts a total of 64 clinical trials that it is helping to finance. Two of the Covid trials are taking place at the University of California, San Francisco-UC Davis and the City of Hope in the Los Angeles area. The third involves a New Jersey firm called Celularity, Inc., which has failed to respond to multiple questions about the California location of its trial. The agency is limited to funding activities within the state. CIRM directors approved the Celularity award on June 26, more than 30 days ago.

The Celularity award has another interesting angle. It involves a treatment supported by President Trump’s personal attorney, Rudi Giuliani. 

You can find more information about all the awards in a series of items on CIRM’s blog, The Stem Cellar, using the search term “covid.”   Five CIRM/Covid stories, including CIRM blog items about the Covid round, have been placed on the campaign website by the campaign staff. 

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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.

Juggling California Stem Cell Scenarios: Rebirth or RIP?

Directors of the $3 billion, California stem cell agency on Friday will be engaged in a curious mix of end-of-life planning plus a serious look at the possible rebirth of the 15-year-old program, which is unprecedented in state history.

On the meeting's agenda is a proposed budget for the 12 months beginning in July, which amounts to a wind-down plan if voters reject a $5.5 billion bond measure this fall that would refinance the agency. The agency has run through nearly all of the $3 billion provided by voters in 2004.  The spending plan would wrap up ongoing multi-year grants, archive records and help to assure that the state receives any royalties for stem products that it has helped to finance. 

On a positive note, the 29 directors will discuss the $5.5 billion ballot initiative and almost certainly endorse it.  The measure is more than money. The initiative would not only provide cash via the issuance of state bonds but charge the agency with more specific responsibilities, such as spending at least $1.5 billion on "diseases and conditions of the brain and central nervous system, including but not limited to Alzheimer's disease, Parkinson's disease, stroke, dementia, epilepsy, schizophrenia, depression, traumatic brain injury, brain cancer, and autism." 

The measure is also aimed at ensuring accessibility to any new stem cell therapies, whose prices could run to $1 million or more. The agency, however, has yet to participate in funding a stem cell therapy that is widely available to the public.

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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.

A campaign organization called Californians for Stem Cell Research, Treatments and Cures has already been created. It has a website and is soliciting contributions for what could be a $50 million campaign. Interested persons can also sign up for its mailing list. No opposition campaign group has surfaced, although the Center for Genetics and Society in Berkeley has raised serious questions and reservations.

The ballot initiative has not yet qualified for the November ballot. However, short of an extraordinary event, it seems all but certain to be placed before voters. 

The California Institute for Regenerative Medicine (CIRM), as the agency is formally known, was created in 2004 by voters through the use of the state's ballot initiative process, a "direct democracy" tool that permits those who can gather hundreds of thousands of signatures to take their proposals directly to voters.  Initiatives bypass the legislature and the governor.  CIRM also operates effectively outside of the control of the governor or lawmakers under the terms of the initiative that created it.

A scientific research state agency funded with billions of dollars has never existed in California history. It is the largest such state stem cell effort in the nation. At one point it was the single largest source in the world for funding human embryonic stem cell research. 

Friday's online meeting, which begins at 9 a.m. PDT, is open to members of the public who can comment on any issue. Full directions for the online access are on the agenda.  If you haven't logged into a meeting of the agency previously, it would be helpful to review the instructions on the agenda 15 minutes in advance. 

Signature Drive Ends for $5.5 Billion California Stem Cell Initiative; Will it Qualify for the Ballot?

Backers of a $5.5 billion ballot initiative to save the California stem cell research program from financial extinction said today that they had finished their petition drive to qualify the measure for the November ballot and expressed confidence that they had the more than 600,000 signatures needed. 

The announcement came after the campaign had missed three of its self-imposed deadlines for collecting 950,000 signatures as well as the state-recommended deadline of April 21.  The campaign said that the petitions have been delivered to county election officials around the state for verification of the signatures, a lengthy process that must be completed by June 15. If the work is not finished by then, the measure will not appear on the ballot. 

The initiative needs 623,212 valid signatures to qualify. The campaign's news release today said it had 925,000, down from its goal of 950,000. However, disqualification rates can run as high as 50 percent. Early last month after its public signature-gathering was halted because of coronavirus restrictions, it said had only 915,000. The campaign then kicked off what it called an "unprecedented," Internet, mail-in campaign to solicit signatures.  Later it began a direct mail effort, also unusual for an initiative qualification drive. 

The stem cell agency was created in 2004 by another ballot initiative and financed with $3 billion in state borrowing. It is now running out of money and will begin closing down in the fall if substantial funding is not received. 

Robert Klein, chairman of the campaign, said he was "confident" that the campaign had enough valid signatures to qualify for the ballot. He said, 

“Submitting signatures in time to qualify for the general election would not have been possible without our coalition of patient advocates, who banded together to help us
overcome the unprecedented challenge of signature gathering during a global pandemic – the effort is emblematic of our movement that has been widely supported and driven by patients and their families from the beginning”

Klein, who led the 2004 ballot campaign that created the agency, also cited the $5 million special, Covid-19, grant round now being conducted by the stem cell agency as example of the valuable work performed by the agency, officially known as the California Institute for Regenerative Medicine (CIRM).

One of the recipients of  a $750,000 award in the covid round, John Zaia of the City of Hope, was quoted in the campaign news release as saying,  

“We could be on the brink of medical discoveries that could save the lives of patients impacted by Covid-19 and other diseases, and this research simply would not be possible without the initial investment Californians made in the state’s stem cell program in 2004.

“Now, it is absolutely critical that this investment is renewed, allowing researchers like myself to continue to discover treatments and cures that can improve or save the lives of patients today and for generations to come.”

The City of Hope and many other recipient institutions have had a seat on the CIRM governing board since its inception.  According to CIRM figures, the City of Hope has received $117 million in grants since 2005. Zaia has received $33 million. 

The process of verifying and counting signatures is tedious under normal circumstances. County officials are now further hampered by work-related restrictions created by the coronavirus crisis. 

It is not clear whether enough signatures can be verified by June 25. That's the state deadline for qualifying for the November ballot. Two other unrelated initiatives failed or were withdrawn yesterday, state election officials said. Ironically one of the proposals would have allowed for the gathering of signatures online as a way to speed the task. 

The campaign has removed from its web site the outdated information concerning its petition solicitation effort, including the phrase "time is running out," which ran on its home page. But here is a link to the petition page from April 22 as archived by the California Stem Cell Report:  

A Stem Cell Ballot Initiative in Your Mailbox: Thank you Montgomery Ward

The campaign to refinance California's stem cell agency took a tool from Montgomery Ward in its effort to qualify a $5.5 billion measure for the ballot this fall. The unusual -- for a ballot initiative -- tactic was part of a last gasp push to secure 950,000 signatures. Whether it was successful will be determined in the upcoming weeks. Here is a piece from Capitol Weekly, where it was initially posted, that examined how the direct mail effort worked. The article was written by yours truly.

For survival, stem cell agency hunts for ‘wet signatures’

BY DAVID JENSEN POSTED 05.05.2020

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The folks who are trying to save the $3 billion California stem cell agency from financial extinction are using a well-worn technique that goes back to ancient Egypt, at least by some accounts.

It is expensive, depending on what you are peddling, and generates a return as low as 1 percent. It is direct mail, but with a significant twist. It involves the collection of “wet signatures” and the signing of documents that must be produced in a fussy, legal fashion.

The process requires a bit more commitment from voters than, say, returning a pitch from the Readers Digest Sweepstakes. And it is likely that the effort is the first time that anyone has made a major push — both by direct mail and online — to collect tens of thousands of voters’ signatures to qualify an initiative for the ballot in California.

It is a life or death matter for the California Institute for Regenerative Medicine (CIRM), otherwise known as the state stem cell agency. CIRM is running out of money and will begin to close its doors next fall unless it receives a life-preserving jolt of cash. The proposed ballot initiative would do that nicely with an injection of $5.5 billion.

Ordinarily, qualifying a measure for the ballot in the Golden State is simple. All you need is money. The cash goes to firms that hire hundreds of people to solicit hundreds of thousands of signatures in public places. The coronavirus put a stop to that sort of public behavior back in March.

The result was a big crimp in the plans of the “Californians for Stem Cell Research, Treatment and Cures,” as the campaign has dubbed itself.

It announced that 35,000 more signatures were needed. “Time is running out,” the campaign warned on its web site.

On hand were 915,000 signatures. Qualifying the measure for the ballot requires only 623,212 signatures of registered voters. But disqualification rates for ballot initiative signatures can run as high as 50 percent, and the campaign wanted a bigger cushion.

It fired up what it described as an “unprecedented,” effort online, but one that is a tad complicated.

First, someone interested in finding a stem cell petition to sign must know that they can find one on the Internet, which is a big ask. Then, if their search leads them to the proper web site, they will encounter lengthy instructions.

The process is not simple. The campaign’s web site mentions “wet signatures,” ones that are signed in ink. Then there is the need to print out the 16 pages of the petition from the web site and the need to complete the “circulator declaration.” A seven-minute, “sign-at-home training”  video was posted by the campaign to guide wandering supporters along the signature trail. 

About April 13, the campaign quietly boosted its cyberspace pitch with direct mail, presumably targeting households likely to be sympathetic to spending $5.5 billion for stem cell research via the ballot initiative.

A packet of the direct mail material surfaced recently in Santa Barbara.  The California Stem Cell Report subsequently asked the campaign about the direct mail effort, but it has remained all but mum, with the exception of providing a rough start date for direct mail effort. Unanswered are such questions as how many packets were mailed, their return rate and cost and whether there is a precedent for mailing out petitions in this fashion?

The campaign’s direct mail effort is significant and holds some promise. But the  tasks for recipients take time and pose some barriers that can lower a response rate.

The question is whether the unusual effort will pay off?  To answer that, let’s assume that the direct mail pitch generates a 2% return with an average of one signature per household, which may be generous based on what is known about direct mail efforts. Let’s assume that the campaign would like to gather by direct mail only a portion of the 35,000 signature shortfall, for example, about 15,000. That would mean producing and mailing 750,000 packets to collect 15,000 signatures, which, of course, also need to come from verified registered voters.

Costs are not insignificant. Aside from postage, one web site estimates that production costs for business direct mail range from 30 cents to $10 each, depending on size and complexity.

Direct mail does work. That’s why it has been around in a significant way for many decades and fills your mailbox every day. It is not clear who in the campaign came up with its direct mail plan. But the campaign is very much the creature of Robert Klein, a Palo Alto real estate developer who also directed the 2004 campaign that led to the creation of the stem cell agency. He spent more than six years as its first chairman and is the chairman of his own stem cell advocacy group, Americans for Cures, which has offices in Klein’s Palo Alto building.

Klein is acutely aware that next November could mean the extinction of an enterprise he has devoted years to. Few good alternatives exist beyond passage of this year’s initiative. It’s this year or never, he basically told CIRM directors in 2017.  No one, however, could have predicted the coronavirus crisis that halted normal signature gathering. So today Klein is emulating the direct marketing examples of a landowner in ancient Egypt and of a man named Aaron Montgomery Ward who launched his first one-page catalog in 1872 and who can be considered the father of modern direct mail.

California will soon know whether Klein has been as successful as Mr. Ward, whose catalog became imbued in American culture as the nation’s “Wish Book.”

News Coverage of Capricor and California Stem Cell Agency Less Than Abundant

Capricor Therapeutics' stock price retreated today after soaring 253 percent yesterday on the news that one of its products had successfully treated a small group of critically ill, Covid-19  patients.

The price closed today at 7.00, down from yesterday's close of $8.50. That was the highest price for the Beverly Hills firm since 2018.

While the news about its CAP-1002 treatment excited investors, it did not stir the news media. In the glut of hundreds of stories about the coronavirus, the mainstream media did not even mention Capricor. Nor did the Los Angeles Times, virtually the home town paper for the firm. As for the California stem cell agency, which has pumped nearly $25 million into Capricor-related research, the role of the agency was also among the missing.

The Los Angeles Business Journal did carry a tidy and straight forward story, again one that did not mention the stem cell agency, which is hoping that California voters will save its financial life next fall. That is, if they approve a proposed, $5.5 billion, ballot measure that has already missed one state-recommended deadline (April 21) for qualifying for the ballot. BioWorld also had a story that did not mention the California agency's role. 

The agency is running out of the $3 billion that voters provided for it in 2004 when they created the unprecedented state research program. It will begin closing its door in six months unless major funding is found.

The sparse news coverage of the agency will be a challenge for the agency's backers as they seek voter approval of the ballot measure, assuming it qualifies.

Two Deadlines Missed by Supporters of $5.5 Billion, California Stem Cell Measure

Backers of a $5.5 billion stem cell research proposal in California today have once again missed a self-imposed, but critical deadline as they continue to struggle with securing enough signatures to place the measure on the November ballot.

The campaign's website this morning listed what is now its third deadline for gathering the signatures of 950,000 voters. Previously, the campaign had set an April 11 deadline and then an April 18 deadline. The latest deadline is tomorrow (April 21). The rolling extensions do not augur well for its "unprecedented" attempt to collect signatures via a combined online and mail-in effort. 

In response to questions from the California Stem Cell Report, Sarah Melbostad, a spokeswoman for the campaign, declined to elaborate on the campaign's progress or lack of it beyond a statement she released on Friday.

The questions ranged from just how many signatures the campaign currently has in hand to when they might be presented to election officials. (Here is a link to the text of all the questions.)

The campaign's ballot initiative is aimed at staving off the financial demise of California's stem cell agency, which has all but run out of the $3 billion that it was provided by voters in 2004, also through a ballot initiative.  Known formally as the California Institute for Regenerative Medicine (CIRM), the agency has no other significant funding source than state-issued bonds.

The coronavirus crisis has blocked the usual method of gathering of ballot initiative signatures at shopping malls and other public locations. The campaign said earlier it needed another 35,000 signatures to hit its goal of 950,000. The legal requirement is only 623,212 but many signatures are disqualified as invalid, sometimes as high as 50 percent.

Another obstacle involves officials in the state's 58 counties, who must certify the signatures. Most, if not all, are short-staffed because of the coronavirus and/or must provide a working environment that is likely to slow the signature count. If the count is not completed by June 15, the stem cell measure will not be on the November ballot and the agency will begin closing its doors.

Time Running Out for $5.5 Billion California Stem Cell Ballot Initiative

Backers of a proposed $5.5 billion, stem cell ballot initiative are pressing on with their cyberspace campaign to assure that the measure will qualify for the November ballot despite "a landscape (that) is changing on a daily basis."

But as the campaign's website notes, "Time is running out."

No fresh figures for the number of signatures have been released since early this month. The campaign has also extended to this Thursday its self-imposed deadline for collecting 950,000 signatures. The campaign originally hoped to have the signatures in hand last Saturday.  

At stake is the financial life of the California stem cell agency, which is running out of money and is expected to begin the process of closing its doors next fall unless it receives an infusion of cash. The ballot initiative needs 623,212 signatures of registered voters to make the November ballot.  At last report, it had 935,000. However, the disqualification rate of signatures on petitions can run as high as 50 percent. 

County election officials are also working under Covid-19 conditions, which can mean a reduced work force and limited hours for verifying signatures. At some point, moreover, the mechanics of printing and delivering the ballot information that must go to nearly 20 million voters come into play for state election officials. 

Responding to a query from the California Stem Cell Report, campaign spokeswoman Sarah Melbostad released a statement yesterday that said:

"This new virtual signature gathering effort was launched just last week, and as it takes time to count the incoming signatures by mail, we do not have an updated number to share. 

"The campaign is aiming to give the counties as much time as possible to verify signatures, however the landscape is changing on a daily basis, and adapting to new challenges during these uncertain times requires nimble decision-making and flexibility. 

"Voters can continue to visit our website https://caforcures.com/help-us-qualify/ to sign the petition and learn how they can help ensure the continuation of treatments and cures that could save or improve the lives of millions."

The stem cell measure is not the only initiative that is facing problems. It could well be that the governor may take some sort of emergency action to extend deadlines for all of them. 

Earlier this month, the stem cell campaign launched an "unprecedented" electronic, mail-in effort to gather the final number of signatures that were judged to be needed. It is a daunting process to conduct online and then have the petitions returned in the mail. 

The campaign web site stresses the urgency and pressing need for more signatures. "The campaign must gather the last 35,000 signatures through mail-in submissions by April 16th," the web site says. 

A Grim Picture? Nuts and Bolts of California's Ballot Petition Pinch and $5.5 Billion for Its Stem Cell Research Program

Here is a not-so-hypothetical question: In these days of the coronavirus crisis, is it safe to touch a mailed-in petition to place a $5.5 billion stem cell research proposal on the November ballot?

While some may consider the question dubious, it is in, in fact, a real question for enterprises attempting to win a position on the ballot next fall. And it illustrates the difficulties facing backers of the proposed stem cell ballot measure, which is aimed at saving California's stem cell agency from financial extinction. 

The agency is running out of money and will begin to close its doors next fall unless more cash is coming in.

Lisa Renner wrote yesterday about California's ballot petition pinch for Capitol Weekly, a respected online news service that follows state governmental and political affairs. She said,

"It’s never easy to get initiatives qualified for the ballot, but this year of the COVID-19 pandemic is the worst ever....

"While organizations technically have until April 21 to turn in signatures to qualify for the November ballot, the shutdown effectively means that those that didn’t collect enough signatures by mid-March probably won’t make it. At best they can hope for possibly qualifying for November 2022."

Renner painted a vivid picture of the nuts-and-bolts of the petition business. She quoted Fred Kimball, owner of Kimball Petition Management.

"Kimball is faced with the challenge of confirming the signatures to make sure they are from unique registered voters. In a normal year, he said he has 75-100 people crammed in his office checking signatures. But this year, he has only six workers in house while the rest are looking at petitions from home.

"'I haven’t done this ever,' he said. 'Usually the petitions never leave the site of the office. There’s a lot of trust you put into the workers. It’s very difficult.'

"Some employees have quit because they don’t want to touch papers that have been handled by so many people and thus could be contaminated with the virus. To deal with that concern, Kimball has set a new rule that new signatures pages that come in his office must sit for one week before anyone touches them again. He also requires employees in house to wear masks and gloves."

Kimball's firm is working on the ballot proposals dealing with kidney dialysis and medical negligence. But his comments bear on any proposed initiative. 

In the case of the stem cell measure, it needs 623,212 valid signatures of registered voters to qualify for the ballot. Backers say they have 915,000 and need another 35,000 in order to account for disqualified signatures. They have launched an ambitious and "unprecedented" effort to circulate petitions via the Internet.

"Proponents usually seek at least 50 percent more than the legal minimum number of signatures to compensate for possible duplicate or otherwise invalid signatures," according to Wikipedia.

Capitol Weekly's Renner also reported on the stay-at-home orders facing county elections officials.

"Most have shut down all offices, requiring initiative supporters to set up appointments to drop off petitions. Much of their staff is also working at home, which sets up the new burden of getting the petitions to employees."

She continued,

"Joseph Holland, the Santa Barbara County clerk, recorder, assessor and registrar of voters, said his office hasn’t even finished certifying the March 3 election and is facing employees out sick and suddenly charged with taking care of their children after schools closed. “We are operating with a skeleton crew,” said Holland, who also serves as president of the California Association of Clerks and Elections Officials. 

"While his employees are considered essential under the shut-down order, figuring out logistics about where they sit is an issue. They can no longer sit side by side at cubicles as that would violate the 6-foot social distance rule. “It has reduced our capacity by half.” 

"For petition signatures that come in on a single page, the county is able to scan them and electronically send them to employees working at home for validation. But the county is not able to scan petitions that come in booklet form. Those must still be validated by employees at the office, Holland said."

The verification process involves random samples, which can trigger a full check of each signature, slowing the process considerably. There is a possibility that the current legal requirements could be modified, but that change would likely involve the governor and the legislature. 

The campaign for the stem cell measure has set for itself a deadline of this Saturday to finish collection of signatures. 

Final Cyberspace Dash Underway for $5.5 Billion California Stem Cell Initiative

Above is the instructional video from the stem cell initiative campaign web site. 

The campaign to save California's stem cell research program from financial extinction is making an "unprecedented," electronic sprint to gather the final signatures to qualify its $5.5 billion rescue measure for the November ballot. 

In the next eight days, the campaign says it needs 35,000 more signatures to be sure that the multi-billion-dollar ballot initiative is presented to voters next fall. 

The stem cell agency, officially known as the California Institute for Regenerative Medicine (CIRM), is running out of money. It will begin closing its doors in November without more funding.  The campaign's web site says, 

"Over 915,000 voters have already signed petitions to help qualify our initiative for the November 2020 ballot. In the last full week before public signature gathering was shut down due to the coronavirus, over 120,000 voters signed – a tremendous response. But we need at least 950,000 signatures to secure a place on the California ballot this fall. 

"Help us meet our goal by signing and returning a petition today. The campaign must gather the last 35,000 signatures through mail-in submissions by April 11th."

In response to questions from the California Stem Cell Report, campaign spokeswoman Sarah Melbostad described the online move as "unprecedented." She said,

"What’s happening right now across the world is unprecedented, which means the innovative changes we’re making to gather signatures through a mail-in option are unprecedented as well." 

The campaign's unusual Internet pitch is aimed at putting petitions in the hands of its supporters. The effort requires downloading documents, reading detailed instructions on filling them out and then returning them by regular mail. Normally, paid signature gatherers take care of all that.

The process is not simple and is likely to be daunting for some.  The campaign's web site mentions "wet signatures," the importance of printing out the 16 pages of the petition and the need to complete the "circulator declaration." A seven-minute instructional video has also been posted by the campaign (see above). 

The campaign's message stresses speed. 

"Time is of the essence; a fast response is needed to preserve our opportunity to guarantee our ballot position."

The legal minimum of valid signatures of registered voters is 623,212. The extra hundreds of thousands of signatures are needed because many are disqualified by election officials during the certification process.

The campaign's online pitch also includes a schedule of 30-minute webinars aimed at building support and answering questions. They begin tonight at 6:15 p.m. PDT and continue on April 5, 7 and 11. 

California Pumps $5 Million into Search for Stem Cell Treatment for Covid-19

Coronavirus

California's stem cell agency, in an emergency action, has allocated $5 million for research into treatments for Covid-19 and set the deadline for the first applications for one week from today. 

The agency, formally known as the California Institute for Regenerative Medicine (CIRM), approved the funding last Friday during an emergency meeting of its governing board. 

In an item yesterday on the CIRM blog, Maria Millan, CEO and president, said,

"California researchers have made us aware that they are pursuing potential stem cell based approaches to the Covid-19 crisis, and we felt it was our responsibility to respond by doing all we can to support this research and doing so as quickly as we possibly can."

The agency set accelerated timetables for action, both by the agency and applicants. It said it would expect winning applicants to begin work within 30 days of being approved. 

CIRM's move comes as itself is facing a mortal financial threat. It was created by voters CIRM in 2004 with $3 billion. It is now down to its last $27 million and is hoping voters will approve $5.5 billion more via a proposal that is yet to qualify for the November ballot. Otherwise CIRM's doors will begin to close in the fall. 

Presumably, billions of private and public dollars are already pouring globally into the search for various aspects of Covid-19, so the $5 million is a relatively tiny amount. CIRM has developed a speedy process, however, for bringing funds to bear on research and is acting to accelerate that even further. 

Jonathan Thomas, chairman of the CIRM board, said, 

"The coronavirus is creating an unprecedented threat to all of us and, as one of the leading players in regenerative medicine, we are committed to doing all we can to develop the tools and promote the research that will help us respond to that threat." 

The campaign to qualify the $5.5 billion initiative for the ballot released a statement heralding the action by CIRM. Robert Klein, the Palo Alto real estate developer behind both the original ballot measure and this year's funding initiative for CIRM, said, 

"The investment by California’s stem cell institute to combat Covid-19 highlights the remarkable potential of this research and therapy development to impact the lives of every Californian. ...We urge Californians to think back on this moment, when they decide the fate of future life-saving stem cell discoveries and treatments come November."

The campaign said 10 days ago that it has suspended the gathering of signatures. It is not clear whether it has enough to qualify for the fall ballot. More than 600,000 valid signatures are required. 

Here are links to additional CIRM information on its Covid-19 program:

• Concept statement
• Application information and timetables
• Presentation slides from last week's meeting
• CIRM's news release

California's Big Research Tent: Beyond Stem Cells and Into VROs

California's $3 billion stem cell research program is unprecedented in state history, and it is now ready to mark another first: Backing a couple of clinical "VROs"  with $13.5 million.

VRO is a term that only a policy wonk could love or perhaps a researcher seeking funding under the rubric. It is not exactly posted on the home page of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known. It is nestled comfortably among the 10,000 words of the 2004 ballot initiative that created CIRM.

VRO stands for vital research opportunity. It is fair to say that few persons are aware of the language or know that CIRM's funding authority is something of a big tent that can go well beyond stem cells. Or that CIRM's program could be more expansive under a new, proposed $5.5 billion ballot initiative.

CIRM's governing board set the stage for the awards last November when it approved a VRO process for gene therapy research that did not involve stem cells but involved an aspect of regenerative medicine.

According to the meeting transcript, an application for an award would be considered a VRO if, among other things, "the approach is intended to replace, regenerate, or repair the function of aged, diseased, damaged, or defective cells, tissues, and/or organ. This basically constitutes the definition of regenerative medicine and brings that as a requirement."
 
A VRO designation also requires a two-thirds vote of the grant reviewers, who conduct their meetings behind closed doors.

On Thursday, the board is expected to approve its first two VRO proposals. One for $8 million targets Parkinson's disease. The summary of the review said the research has "the potential to slow disease progression and provide amelioration of motor symptoms."

The other is a $5.5 million award for treatment of a rare autoimmune disease called IPEX. The summary of the review said the research offered "a valuable alternative to the current standard of care options, which have significant toxic side effects."

VRO awards are permitted under the 2004 ballot measure, which says:

"The institute shall have the following purposes: (a) To make grants and loans for stem cell research, for research facilities, and for other vital research opportunities to realize therapies, protocols, and/or medical procedures that will result in, as speedily as possible, the cure for, and/or substantial mitigation of, major diseases, injuries, and orphan diseases."

Currently on file with state election officials is a proposed ballot initiative that would provide an additional $5.5 billion for the agency, which is soon expected to run out of cash for new awards.

The measure would make a number of changes in CIRM, including permitting the agency to venture even farther afield than permitted under the 2004 language.

The measure would impose a new requirement that the agency support training programs for "careers in stem cell research and other vital research opportunities." It would establish experience in "other vital research opportunities" as acceptable criteria for the selection of governing board members and the chair of CIRM. The criteria would apply also to the grant review group and appointments to a new scientific advisory board.

The proposed ballot measure also defines a VRO as including personalized medicine, genetics and aging. Here is the proposed, new language:

"Vital research opportunity means scientific and medical research and technologies, includinq but not limited to qenetics, personalized medicine, and aqinq as a patholoqy, and/or any stem cell research not actually funded by the institute under paragraph (3) of subdivision (c) of Section 125290.60 which provides a substantially superior research opportunity, vital to advance medical science as determined by at least a two-thirds vote of a quorum of the members of the Scientific and Medical Research Funding Working Group (reviewers) and recommended as such by that working group to the ICOC (the governing board),or as determined by the vote of a majority of a quorum of members of the ICOC. Human reproductive cloning shall not be a vital research opportunity."

The language still can be modified by the initiative backers prior to being certified for the November 2020 ballot. Here is how that mechanism works. 

California Stem Cell Health Dividends: A Whopping $900 Billion? Maybe Only $175 Billion?

A team of University of Southern California researchers said today that work by California's stem cell agency could pay off with nearly $900 billion in "health dividends" by 2050 by treating or curing afflictions ranging from diabetes to heart disease.

The study, commissioned by the agency, acknowledged the difficulty in forecasting the benefits of research backed by the the state program, which is unprecedented in California history. But the report said,

"We find that nearly half of Californians aged 50 and older will develop diabetes during their lifetime. Furthermore, more than one-third will experience a stroke, and between 5 and 8 percent will develop either breast, colorectal, lung, or prostate cancer.  

"Taking into account the high prevalence and the social and economic burden of these diseases, an intervention that reduces the incidence of these selected cancers, diabetes, and stroke by 50 percent would generate almost $900 billion in social value between 2018 and 2050.  

"A more modest 10 percent decline in incidence translates to $175 billion in social value during the same period. Put in this context, the CIRM investment would be worthwhile if it increased our chances of success even modestly. Against the billions of dollars in disease burden facing California, the relatively small initial investment is already paying dividends as researchers work to bring new therapies to patients."

The agency, known formally as the California Institute for Regenerative Medicine (CIRM), was created by voters in 2004, who provided it with $3 billion. It has yet to fund a product that is widely available to the public. However, the agency is involved in 56 clinical trials, which are the last stage before a treatment is certified for widespread use.

CIRM expects to run out of cash for new awards by the end of this month. It hopes that a proposed initiative for the November 2020 ballot will provide it with an additional $5.5 billion. 

Today's report, titled "Future Health Dividends for California," and its companion study last week on the agency's economic impact are likely to be significant topics during the 2020 campaign. 

The 22-page study came up with a "social value" calculation using the Future Elderly Model -- "a microsimulation model of health and economic outcomes for older Americans." Basically it involves quality of life outcomes as well as more straight forward financial projections. The study also lays out its methodology and limitations including an acknowledgement that the projections are not guaranteed. 

Today's report and last week's economic study cost CIRM a total of $206,000. The work was performed at USC's Leonard D. Schaeffer Center for Health Policy & Economics. The authors are Bryan Tysinger, Karen Mulligan, Henu Zhao, Alwyn Cassil  and Dana Goldman.

Here is a link to an item on the CIRM blog about the study.

USC vs. UC San Diego: Unprecedented $50 Million Settlement in Academic Recruiting War

The University of Southern California in Los Angeles is coughing up $50 million and publicly apologizing for its tactics in recruiting a star Alzheimer's resarcher from UC San Diego, it was reported Thursday.

The Los Angeles Times story about the unprecedented settlement described the case as an "ugly academic war." It had the potential of bringing $340 million in research grants to USC.  

The move settled a $185 million lawsuit that at one point involved two directors of the $3 billion California stem cell agency, along with researcher Paul Aisen.

The Times story said the "unprecedented litigation in which UC accused its private rival of repeatedly stealing away top scientists and their lucrative research grants with 'predatory' practices and a 'law-of-the-jungle mind-set.'"

Aisen was a neurology professor at UC San Diego. He and his lab staff left the La Jolla school in 2015. The Times reported that the departures were secretly orchestrated by top administrators at USC.

The Times story, written by Harriet Ryan and Teresa Watanabe with additional reporting by Bradley Fikes, said,

"The self-described 'quarterback' of Aisen’s recruitment was then dean of USC’s Keck School of Medicine Carmen Puliafito, subsequently revealed to have been using drugs and partying with criminals during the time he was courting the scientist."

At the time, Puliafito and David Brenner, dean of the UC San Diego medical school, were both members of the governing board of the California Institute for Regenerative Medicine (CIRM), as the stem cell agency is formally known. Aisen, however, has not received funding from CIRM, which has financed $56.5 million in other Alzheimer's research. 

According to the Times, the apology said that the recruitment tactics "did not align with the standards of ethics and integrity which USC expects of all its faculty, administrators and staff."

The Times story continued,

"UCSD Chancellor Pradeep Khosla welcomed the settlement and said he was open to working with USC in the future.
"'For California and the country, it’s good that two great research universities can work on the Alzheimer’s problem,' he said in an interview. 'I look forward to a constructive collaboration in the future in solving other societal problems.'
"It is not unusual for professors to move to other institutions, but it is often a collegial process in which the universities work together to transfer grants and research."

The Aisen case was not the first instance of USC researcher poaching. The Times wrote,

"In 2013, Puliafito lured two well-funded brain researchers from UCLA, outraging the state university, which complained to government regulators. USC agreed to pay UCLA more than $2 million in a confidential settlement."