Thursday, June 25, 2020

'War With a Deadline' and Its Casualties: A California Stem Cell Perspective

One way to look at campaigns for such things as a $5.5 billion stem cell ballot initiative or a political race for governor is that they are "war with a deadline."  

The bottom line is to win -- in the case of the stem cell measure -- by Nov. 3. If the proposition fails, the California stem cell agency dies.

Many commentators argue that often the first casualties of such "wars with deadlines"  are "facts" and "truth." And then there are matters that are arguable, at least in the eyes of some. 

Consider the monetary description of the initiative. The proposal is dubbed a $5.5 billion measure. That is the amount of state bonds that would be issued. But bonds are simply borrowing by the state. There is interest that needs to be paid by California citizens -- an estimated $2.3 billion. 

So is it a $5.5 billion or $7.8 billion measure? Which is correct? Which figure should the mainstream media use? Which figure should the California Stem Cell Report use? Is it a "lie" to indicate that the measure amounts to only $5.5 billion? We are deeply interested in how this is perceived. It will affect how we write about the measure over the next four months. Please send your responses to djensen@californiastemcellreport.com. 

In all fairness, we have used a $5.5 billion figure almost entirely, and a $3 billion figure for the last 15 years for a quick shorthand reference to indicate the size of the effort since 2004. We have had qualms about using the figures and have laid out the interest costs from time to time. 

Another possible casualty of the "war with a deadline" involves what seems to be simple: the number of clinical trials that have been backed by the California Institute for Regenerative Medicine (CIRM), as the stem cell agency is formally known. 

The campaign issued a news release on Monday that reported 80 trials. The CIRM website says only 63. What gives? 

We asked the campaign about the matter yesterday. It responded quickly with an explanation that basically said it was counting all clinical trials anywhere that somehow involved results generated from CIRM-financed work. 

Is that a "factual" way to describe to voters how many clinical trials the state of California/CIRM is participating in or has participated in? Or is it exaggeration/hype that will ultimately discredit the campaign or the stem cell agency? Especially when it becomes part of a host of claims that seem to push the envelope. 

Again, I invite readers to weigh in at djensen@californiastemcellreport.com. Or you can respond by using the comment function at the end of this item. 

Here is what the campaign sent the California Stem Cell Report yesterday on the clinical trial question. Our thanks to them for a quick and straight-forward reply.
"Our news release from earlier this week said 'CIRM’s program has already saved and improved lives through the advancement of more than 80 clinical trials.'

"This has been done through CIRM directly funding 60+ clinical trials and another 20+ trials conducted based off CIRM funded scientific discoveries. Please see below for list of trials and their clinical trial ID that would not have been able to advance to clinical trials without the initial funding from CIRM."

Disease Category
Clinical Trial ID
1
Brain Cancer
NCT02192359
2
Blindness/Macular Degeneration
NCT01691261
3
Hematologic Malignancies
NCT01546038
4
Myelofibrosis 
NCT01420770
5
Myelofibrosis
NCT00631462
6
Myelofibrosis, Polycythemia vera
NCT01523171
7
Polycythemia Vera and Essential Thrombocythemia 
NCT01420783
8
Polycythemia, Essential Thrombocythemia 
NCT01437787
9
Cardiomyopathy (CADUCEUS)
NCT00893360
10
Cardiomyopathy (DYNAMIC)
NCT02293603
11
Spinal Cord Injury 
NCT01772810
12
Advanced Malignancies 
NCT01697527
13
Cancer
NCT04023071
14
Solid Tumors
NCT02216409
15
Ovarian Cancer
NCT03558139
16
Non-Hodgkin's Lymphoma
NCT02953509
17
Hematologic Malignancies (CAMELLIA)
NCT02678338
18
Bladder Cancer
NCT03869190
19
Acute Myeloid Leukemia
NCT03922477
20
Non-Hodgkin's Lymphoma
NCT03527147
21
Knee/Hip Arthroplasty
NCT03981419
22
Alzheimer's Disease
NCT03765762
23
Parkinson's Disease
NCT03713957
24
Danon Disease
NCT03882437
25
Hematologic Malignancies
NCT03833180

Tuesday, June 23, 2020

A Look at What Lies Ahead for the $5.5 Billion California Stem Cell Ballot Measure

Editor's note: This is an extended version of a piece by yours truly regarding the landscape of the ballot campaign for the initiative to refinance California's $3 billion stem cell agency. A shorter version appeared yesterday on Capitol Weekly, the well-regarded, online news service that deals with California governmental and political news. This version includes more on such things as campaign fundraising, justification for the agency and the overall political environment.


A $5.5 billion stem cell bond measure qualified yesterday for the November ballot, but the campaign to win voter approval is facing an array of hurdles that its supporters never envisioned last summer when they were formulating the initiative. 


Call it the Covid-19 crunch. The pressures include a $54 billion hole in the state budget, looming cuts involving schools and medical assistance for the poor, unemployment now standing at more than three million and predictions by the Federal Reserve that things could get worse. Even California’s famed Rosebowl is facing losses of up to $20 million


That is not to mention that the wealthy folks who support such things as stem cell research are also feeling a squeeze from Covid. These are the donors who are usually called upon to help finance what is predicted to be a $50 million campaign on behalf of the measure.


All in all, it is not an environment that would seem to support what some will argue is unnecessary spending. 


The initiative is largely aimed at saving the state stem cell agency from financial extinction. Formally known as the California Institute for Regenerative Medicine (CIRM), voters provided it with $3 billion in state bonds in 2004 to finance research and development of stem cell therapies. Today that cash flow is dribbling to an end. CIRM will begin shutting its doors next fall without a major financial infusion. 


Little noticed so far, however, is how the initiative will also expand the scope of the agency and allow CIRM to venture into arenas that some will argue are a bit remote from scientific research. 


Not unexpectedly, the campaign, Californians for Stem Cell Research, Treatment and Cures,” was pleased with placement of the initiative on the fall ballot. The campaign issued a news release quoting Robert Klein, a Palo Alto real estate developer and chairman of the campaign, as saying, “During the past decade, California has made incredibly thoughtful investments and significant progress along our journey to developing therapies and cures, for diseases and conditions like diabetes, age-related blindness, cancer,  epilepsy, Parkinson’s, Alzheimer’s, and heart disease.


He continued, “It is critical to California families that this vital therapy development pipeline continue to be funded. Our state has always been a leader in medical and scientific research and therapy development, ranking second in the world when evaluated as a nation. Continuing to fund that mission is essential to the health of our families while stimulating the economic recovery for California, with good paying jobs, created by this program.”


The news release also quoted Sandra Dillion, a clinical trial participant and cancer patient advocate. She said, “Since I was diagnosed with a rare form of blood cancer in 2006, there has been a tremendous amount of advancement in research and discovery that has allowed me to be here today, sharing my story, in large part due to the California Institute for Regenerative Medicine supporting the science that saved my life.


 “Without California’s investment in advancing stem cell research and cures, I would not have the same energized, healthy life that I have been able to once again experience.”


The Center for Genetics and Society in Berkeley, Ca., which opposed the 2004 initiative that created CIRM, offered a different perspective.  In response to a query, Marcy Darnovsky, executive director  of the group, told Capitol Weekly that the initiative “does little to ease the serious concerns about CIRM that have been voiced for years by the Center for Genetics and Society, other public interest advocates, and researchers, and echoed by several policy bodies. 


“It does nothing to address CIRM's built-in conflicts of interest, or its lack of legislative oversight -- despite it being an agency supported wholly by public funds. The new proposition makes some things worse; for example, it outsources critically important decisions about ethical standards to an unaccountable national committee. 


“While stem cell research is valuable, there are no longer federal limits on its funding, which was the justification in 2004 for asking California voters to allocate the first multi-billion-dollar pot of money. In the meantime, that campaign's shameless over-promising and hype set the stage for the hundreds of under-regulated commercial stem cell clinics now offering unapproved ‘treatments’ that have caused tumors and blindness.  


She continued, Today, California faces an enormous budget deficit and proposals to slash high-priority social programs that benefit all of us. It remains to be seen whether voters will approve a new multi-billion-dollar measure for CIRM, instead of investing in healthcare, housing, jobs, education, and other pressing needs.”


CIRM declined to comment on the announcement that the measure had qualified for the ballot. The agency’s governing board is scheduled to discuss  the initiative at a meeting Friday and approve a contingency plan if it fails to pass. 


California is still only beginning to reckon with the economic impact of Covid crisis on services ranging from schools to health care for the poor.  Gov. Gavin Newsom has already announced a $54 billion shortfall in the budget. Lawmakers this week sent him a budget for the next 12 months that papers over the worst problems and assumes the federal government is likely to help out later this year, perhaps during the fall election season. 


If federal funding fails to surface, the fate of the ballot measure could become entangled in voter concern over public priorities. Some voters are likely to ask: Should scientists at well-endowed Stanford University, which is the No. 1 recipient of CIRM funding ($388 million in all), receive more millions while poor people throughout the state are squeezed still further on health care?


One CIRM director, Jeff Sheehy, who has served on its governing board since day one, recently raised scientific and public policy questions. In a May email to the California Stem Cell Report, he said, “I'm not sure that the board has a clear, coherent view of the scope of CIRM's research.  And I am not sure the board has a clear idea of what the scientific mission of CIRM should be in the event that new funding comes from the voters.


"I would note as an aside that CIRM has never submitted its scientific program, including all grants made and their impact, to a rigorous, independent scientific review.  In short, I don't think we really know at CIRM where we've been and where we want to go.  We have anecdotes…."(The ellipses are Sheehy’s.)


The multibillion dollar size of the measure -- $7.8 billion with interest payments on the bonds -- is only one financial issue for the initiative’s backers. In 2017, Klein estimated the cost of the campaign at about $50 million, but has more recently declined to update that figure. The 2004 campaign cost about $34 million. 


Paying for all the accoutrements of a campaign seeking the favor of 20 million voters -- TV ads, website, direct mail, etc. -- will require major campaign contributions at fa time when even the wealthy are feeling the Covid crunch. The financial markets, where much of the wealth of the well-to-do resides, are erratic and more than usually unpredictable. Even prior to Covid, an effort by CIRM to raise $200 million in private funding was unsuccessful. 


At the same time, biomedical companies are increasingly interested in stem cell product development, which they shied away from in 2004.  Just this spring, Gilead Sciences, Inc., of Foster City, Ca., bought a firm backed directly and indirectly by CIRM with $45 million. The purchase price was $4.9 billion, a deal that would have been unheard of in 2004. 


 The agency saw the deal as a validation of its judgment and work, a reason for Californians to vote to sustain CIRM’s operations. But others see the rising private sector investment as easing the need for additional funding from California taxpayers. 


The changing nature of the political scene on a national level could also come into play in the fall. In 2004, also a presidential election year, conservative and fundamentalist forces that might have launched a strong anti-stem cell campaign were more focused on re-electing George Bush. This year a strong California turn-out against President Trump could mean more support for the stem cell agency. Gone too are the Bush administration restrictions on federal funding of human embryonic stem cell research, a rallying cry in the 2004 campaign.  


Klein has said he has a poll that shows that 70 percent of Californians support stem cell research. But he has declined to provide a copy of the poll or provide the name of the firm that performed the work. 

 

One of the products that CIRM has supported successfully over the years is hope. Indeed, its new slogan in 2018 was “Something Better Than Hope.” It was emblazoned on the CIRM annual reports in 2018 and continues to appear on CIRM documents.


The agency has a flock of videos of patients appearing at its meetings over the last 15 years and asking for more research. It gives them hope, they say, during the sometimes tearful, emotional appeals. They are powerful presentations that are available on the Internet and are likely to generate support from many voters. 


To date, the agency is helping to support 63 clinical trials, a number that Klein and CIRM supporters would have scoffed at in the early days. The total cost of trials is high and even the $3 billion goes only so far. Clinical trials are the last and key stage before the Food and Drug Administration approves a stem cell treatment for widespread use. The 2004 campaign raised expectations that such treatments were just around the corner. So far, that has not proven to be the case. Nor has the agency yet generated a stem cell treatment that can be used widely.


Society’s experience with Covid-19, however, could generate a positive sentiment for more research aimed at treating the full array of afflictions that bedevil us. The campaign makes it clear on its home page that is the goal and promise of the stem cell initiative -- “to accelerate development of treatments and cures for life-threatening diseases and conditions that affect someone in nearly half of all families.


It is a “motherhood-and-apple pie” argument that is hard to disagree with. November 3 will tell us whether the voters of California do. 

                                                 ##################

















Monday, June 22, 2020

Qualified: California Voters Will Choose in November Whether the State's Stem Cell Agency Lives or Dies

A $5.5 billion stem cell bond measure this afternoon qualified for California's November ballot, where its backers hope that voters will approve it and rescue the state stem cell agency from financial extinction. 

State election officials released a simple statement declaring that the initiative would be presented to the state's 20 million voters, as expected. The measure gathered 716,964 valid signatures of registered voters, according to the count by local officials. The campaign had submitted 924,216 .

The proposal would refinance the California Institute for Regenerative Medicine (CIRM), as the agency is formally known. It is running out of the $3 billion that voters provided for it in 2004. The agency will begin to close its doors next fall without additional funding. 

"A $5.5 billion stem cell bond measure qualified this afternoon for the November ballot, but the campaign to win voter approval is facing an array of hurdles that its supporters never envisioned last summer when they were formulating the initiative.

"Call it the COVID-19 crunch."....

Editor's note: Fresh material has been added to this item since it was originally posted shortly before 4 p.m PDT today. 


California's $5.5 Billion Stem Cell Countdown: Last Week's Hiccup/Drop Explained by State

Clerical error -- That's what happened in the apparent, sudden setback last week in the effort to qualify for the fall ballot a $5.5 billion initiative to refinance the California stem cell agency.

The problem lay with Fresno County, according to state election officials this morning. Fresno submitted to the state a signature count last Wednesday that really was for another initiative and then withdrew it on Friday.   

A new figure has been submitted for Fresno, but the state did not immediately disclose it. 

Even if all of Fresno's signatures were disqualified, the stem cell measure could make the ballot if San Diego County validates 78 percent of its raw signatures. That percentage is the average qualification rate so far for all the counties that have already reported. 

Under the current process, the initiative needs 685,534 valid signatures of registered voters. State election officials last Friday reported 618,362. 

San Diego has 99,899 raw signatures. Seventy-eight percent would be 77,921, which would provide a statewide total of 696,283 when added to Friday's total.

Here is what happened to the number of valid signatures last week. On  Wednesday June 17, the California Secretary of State, which is the state's top election office, reported 635,298 valid signatures of registered voters on the petitions seeking to place the bond measure on the ballot.

Late Friday June 19, the secretary of state, however, reported a total of only 618,362 valid signatures with no elaboration on why the number had dropped.  The listing of all of 58 California counties showed, however, that the count by Fresno election officials had changed significantly. On Wednesday, Fresno was reported as having 23,175 valid signatures. On Friday, that number been zeroed out and removed.
   
Counties are responsible for verifying the number of valid signatures on the petitions to place initiatives on the ballot. They report to the state, which ultimately determines whether the proposal will come before voters. The state reports daily online on the number of valid signatures, usually around 5 p.m., when it closes its  public operations, but sometimes later. 

The process currently underway relies on both an actual count and random samples. 

The state has set Wednesday as the deadline for counties to complete their tally. The state's deadline for itself is Thursday.

Look for the next update on the count this evening or early tomorrow on the California Stem Cell Report, your only independent source of information and news about the stem cell agency for the last 15 years.

Sunday, June 21, 2020

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.

*********

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. 

Saturday, June 20, 2020

California's $5.5 Billion Stem Cell Countdown: Critical Qualification Numbers Drop on Friday with No Explanation

The effort to qualify a $5.5 billion stem cell bond measure for the November ballot unexpectedly lost ground this week in an unexplained drop in the critical count of the number of voter signatures that have been verified on initiative petitions supporting the proposal.

Whether the drop will endanger the qualification of the measure is unclear. State election officials did not respond to queries late Friday nor did the campaign. 

Here is what happened to the number of valid signatures this past week. On  Wednesday June 17, the California Secretary of State, which is the state's top election office, reported 635,298 valid signatures of registered voters on the petitions seeking to place the bond measure on the ballot. It needs 685,534 at this point to be on the ballot. 

Yesterday (Friday June 19), the secretary of state, however, reported a total of only 618,362 valid signatures with no elaboration on why the number had dropped.  The listing of all of 58 California counties showed, however, that the count by Fresno election officials had changed in a major way. On Wednesday, Fresno was reported as having 23,175 valid signatures. On Friday, that number been zeroed out and removed.   

A minor change was reported in Contra Costa county, whose valid signature count increased by 21 between Wednesday and Friday. San Mateo and Inyo counties also reported their verified counts for the first time, respectively 5,699 and 520.

Counties are responsible for verifying the number of valid signatures on the petitions to place initiatives on the ballot. They report to the state, which ultimately determines whether the proposal will come before voters. The state reports daily online on the number of valid signatures, usually around 5 p.m., when it closes its  public operations, but sometimes later. 

The process currently underway relies on both an actual count and random samples. 

The disappearance of the Fresno count could be simply a clerical error or something of that sort.  But that will not be known until Monday when government offices open for normal business.  Two other initiatives currently pending also show no valid signatures being reported from Fresno. 

The state has set next Wednesday as the deadline for counties to complete their tally. The state's deadline for itself is next Thursday.

Look for the next update on the count Monday evening or early Tuesday on the California Stem Cell Report, your only independent source of information and news about the stem cell agency for the last 15 years.

Friday, June 19, 2020

California's $5.5 Billion Stem Cell Countdown: No Fresh Numbers, Still Short of Qualifying

State elections officials reported this morning that there is no change in the figures concerning the qualification of a $5.5 billion stem cell bond measure for the November ballot. 

The measure remains 50,236 signatures short of being placed on the ballot with six counties outstanding. San Diego has the largest number of raw signatures, 99,899 unverified.

The proposed ballot measure, which appears all but certain to qualify, is aimed at financially saving the state stem cell agency, which is running out of cash. It will begin closing its doors in the fall without more funds. 

The state has set next Wednesday as the deadline for counties to complete their tally. The state's deadline for itself is one week from today.

Look for the next update on the count this evening or early Saturday on the California Stem Cell Report, your only independent source of information and news about the stem cell agency for the last 15 years.

Thursday, June 18, 2020

Ballot Initiative Advisory

As of 8:43 p.m. today state election officials had not posted fresh figures on the count that will determine whether a $5.5 billion stem cell bond measure will qualify for the November ballot. The California Stem Cell Report will be monitoring the situation this evening and will post an item on any new figures if and when they become available.

Stem Cell Contingency Planning in California: Winding Down a $3 Billion Operation


The $3 billion California stem cell agency has put together a "wind down" budget for its coming fiscal year -- a spending plan that takes into account the possibility that voters will not refinance the effort with more billions this fall. 

The budget was approved by the agency's governing board finance committee last week. It proposes spending $12.3 million for the 12 months that begin July 1. Should voters reject a $5.5 billion refinancing of the agency in November, the plan anticipates a 42 percent staff reduction at the end of this year. 

The agency is now down to 33 employees, who have numbered more than 50 in past years. 

Maria Millan, CEO of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, said that details of the plan will be fleshed out as the year progresses.  It will also be discussed at a governing board meeting on June 26.

She said that CIRM has $854 million in awards under current management. They would be phased out over the next several years. Millan said that $47 million is available currently for research awards. Decisions on the use of the money will come before the board, also on June 26. 

If the ballot measure is approved, the agency's budget will require substantial modification and hiring to deal with the increased funding and new activities provided for in the ballot measure. 

During the public comment period, David Jensen, publisher of the California Stem Cell Report noted the  significance of CIRM both as an historic state enterprise and for its scientific impact on the stem cell field. He said, 
"Preserving the CIRM story digitally in a readable and accessible format should not be all that costly. And it would be a significant contribution to helping those who come after us learn about how this $3 billion effort came about and navigated with considerable success through the early days of what some may ultimately call the stem cell revolution. It would be a sad day if the complete record of the California Institute for Regenerative Medicine is not preserved for posterity." 
Several CIRM board members expressed enthusiasm for the suggestion. Millan said that archiving the data and information that CIRM has gathered is part of the wind down proposal under its public communication component. 



*This item has been brought to you by The California Stem Cell Report: The only independent source of information and news devoted solely to the stem cell agency for the last 15 years.*

Wednesday, June 17, 2020

California's $5.5 Billion Stem Cell Countdown: 50,236 More Signatures Needed

A $5.5 billion stem cell initiative this afternoon remained shy of qualifying for California's November ballot with only five business days remaining before the count must be complete.

The proposed ballot measure is aimed at saving the state stem cell agency, which is running out of cash. It will begin closing its doors in the fall without more funds. 

State officials today reported 635,298 verified signatures of registered voters, up from yesterday's 610,742. The campaign's goal is 685,534. The qualification rate is steady at about 78 percent. 

The measure needs only 50,236 more to hit 685,534. Six counties with a total of 115,400 raw signatures have not completed their verification. The largest is San Diego, with 99,899 unverified. The others are Butte, 6,502; Inyo, 610; Kings, 1,756; San Mateo, 6,491, and Trinity, 142. 

The state has set June 24 as the deadline for counties to complete their tally. The state's deadline for itself is June 25.

(It is too late for more persons to sign petitions for the campaign.)

Look for the next update on the count tomorrow evening or early Friday on the California Stem Cell Report, your only independent source of information and news about the stem cell agency for the last 15 years.

Text: State Summary of 2020 Stem Cell Ballot Initiative

Here is the text of the summary of California's $5.5  billion stem cell ballot measure from the secretary of state's office.

"Authorizes $5.5 billion in state general obligation bonds to fund grants from the California Institute of Regenerative Medicine to educational, non-profit, and private entities for: 
"(1) stem cell and other medical research, therapy development, and therapy delivery;
"(2) medical training; and 
(3) construction of research facilities. 

"Dedicates $1.5 billion to fund research and therapy for Alzheimer’s, Parkinson’s, stroke, epilepsy, and other brain and central nervous system diseases and conditions. 

"Limits bond issuance to $540 million annually. Appropriates money from General Fund to repay bond debt, but postpones repayment for first five years. 

"Summary of estimate by Legislative Analyst and Director of Finance of fiscal impact on state and local governments:

"State costs of $7.8 billion to pay off principal ($5.5 billion) and interest ($2.3 billion) on the bonds. Associated average annual debt payments of about $310 million for 25 years. The costs could be higher or lower than these estimates depending on factors such as the interest rate and the period of time over which the bonds are repaid. The state General Fund would pay most of the costs, with a relatively small amount of interest repaid by bond proceeds."

(Boldface by secretary of state's office.)

Tuesday, June 16, 2020

California's $5.5 Billion Stem Cell Countdown: Only 74,792 Signatures Left to Go

The effort to qualify a $5.5 billion stem cell initiative for California's November ballot gained 24,606 signatures this afternoon with only six business days remaining before the count must be complete.

The proposed ballot initiative is aimed at saving the state stem cell agency, which is running out of cash. It will begin closing its doors in the fall without more funds. 

State officials today reported 610,742 verified signatures of registered voters, up from Monday's 586,136. The campaign is hoping for 685,534. The qualification rate is steady at about 78 percent. 

The measure needs only 74,792 more to hit 685,534. Eight counties have not completed their verification, including San Diego, with 99,899 unverified. 

The state has set June 24 as the deadline for counties to complete their tally. The state's deadline for itself is June 25.

Look for the next update on the count tomorrow evening or early Thursday on the California Stem Cell Report, your only independent source of information and news about the stem cell agency for the last 15 years.

Monday, June 15, 2020

California's $5.5 Billion Stem Cell Countdown: San Diego County, With 99,899 Raw Signatures, Still Working on Verification

An effort to place a $5.5 billion stem cell initiative on the November ballot in California notched another 48,578 signatures this afternoon with only seven business days left until the count must be complete.

The proposed ballot initiative is aimed at saving the state stem cell agency from financial extinction. The 15-year-old program is running out of cash and will begin closing its doors in the fall without more funds. 

Last week, the California Stem Cell Report analyzed the trends in the tally, concluding that qualification is in the "virtual bag."

Today's tally from state officials showed 
586,136 verified signatures of registered voters, up from Friday's 537,558. The campaign is hoping for 685,534. The qualification rate is steady at about 78 percent. If the qualification rate stays fractionally above 67 percent, the measure will be placed on the ballot. 

The measure needs only 99,398 more to hit 685,534. Ten counties have not completed their verification, including San Diego, with 99,899 unverified. Fresno follows with 29,073 and Contra Costa with 23,167. The remaining counties have much smaller numbers of raw signatures.

The state has set June 24 as the deadline for counties to complete their tally. The state's deadline for itself is June 25.

Look for the next update on the count tomorrow evening or early Tuesday on the California Stem Cell Report, your only independent source of information and news about the stem cell agency for the last 15 years.

Covid-19 and Stem Cell PR: Informing Voters, Loosening Their Pursestrings

The California stem cell agency often has trouble making it into mainstream media coverage, but last week it popped up in a piece involving its special Covid-19 round. 

Some of the "normal" grants from the agency run upwards of $20 million. But in this case, it involved only $701,049. The award carried extra news heft for the San Francisco Chronicle because it went to a local institution, UC San Francisco, and was connected to the hottest medical story in the world. 

Michael Matthay of UCSF was the recipient of the cash on May 15 from the California Institute for Regenerative Medicine (CIRM). Matthay has a phase two clinical trial 
Michael Matthay
UCSF photo

underway for 
acute respiratory distress syndrome, which can kill patients with severe cases of Covid-19. He is using intravenous doses of mesenchymal stem cells (MSC) to help damaged lungs repair themselves. Results will not be known for probably about a year. 

The award will largely be used to expand the clinical trial to UC Davis

"UC Davis serves a population that includes underserved patients, and therefore adding UC Davis as a clinical site will serve the CIRM mission well. Also, please note that our UCSF Alpha Stem Cell application was focused on underserved patients in the East Bay (Sickle Cell Disease) and in San Francisco (Zuckerberg San Francisco General Hospital)."
Running the Davis site will be Rachael Callcut, who led the site at San Francisco General until joining Davis in March, and Tim Albertson,  chair of internal medicine at UC Davis. 
Rachael Callcut
UC Davis Photo
In  Matthay's letter he defended his application (CLIN2COVID19-11823) against criticism by the anonymous reviewers who evaluated it for CIRM. The application was initially not approved by the reviewers, who gave it a score of 72 out of 100. The score was so low that it fell outside the range of normal funding. Among other things, the review summary said that reviewers disagreed about the rationale of the research and expressed concerns about whether enough Covid-19 patients could be enrolled. 

Matthay said in a letter to the CIRM board that 11 Covid patients were already enrolled. As for the rationale, he said, 
"There is substantial pre-clinical data that MSC therapy can decrease lung injury from bacterial and viral pneumonia and hasten lung repair. Our group and other investigators have reported several pathways by which MSCs can reduce inflammation in the lung." 
After receiving the letter and hearing from Matthay via telephone at the meeting, the board overrode the reviewers' action and approved the proposal. 

While Matthay's work received favorable notice in the Chronicle article (written by J.D. Morris), for CIRM it was a mixed bag. The first mention of the state funding said, 
"California has invested billions of dollars in public funds to advance stem cell therapies over the last 15 years or so and, while researchers have made some important progress, a 2018 Chronicle series found that the advancements did not live up to the original promise of the 2004 ballot measure that funded the scientific endeavor."
CIRM fared somewhat better in the next mention in Morris' story: 
"Matthay has no guarantee that the stem cells he’s studying will be useful in treating COVID-19. But it’s worth a shot, said Jonathan Thomas, the board chairman of the regenerative medicine institute. 
"'Given that we’re dealing with something the world’s never seen before, it behooves everybody who has potential ideas to be heard,' Thomas said. 'The notion of stem cell-related treatments ... is something that at least we have to give the opportunity to have a full consideration.'"
Why does the play in the story, its use of photos (three in all) and wording matter?  CIRM is all but unknown to California voters today.  As the proposed, stem cell ballot initiative gains more attention, ongoing media coverage will become increasingly important. It will shape the perceptions of voters who are going to be asked in November to provide $5.5 billion more for CIRM, which is running out of money. The agency has handed out nearly all of the $3 billion that voters provided it in 2004. 

The CIRM story has plenty of plenty of pluses and minuses. CIRM and its backers hope that voters will see more pluses than minuses in the media and vote to continue to finance the agency's search for stem cell treatments for everything from cancer to incontinence. 

Sunday, June 14, 2020

$500,000 to Fight Covid-19 from California's Stem Cell Program

The California stem cell agency on Friday awarded a total of $500,000 to two UCLA scientists to help in the fight against Covid-19, including early stage research aimed at boosting the immune response of older persons. 

The grants are part of a $5 million, "emergency" Covid round that is aimed at fast-tracking promising research. 

Song Li (left) and Vaithilingaraja
Arumugaswami, UCLA photos
Vaithilingaraja Arumugaswami
received $350,000 for work dealing with Berzosertib, a therapy targeting viral replication and damage in lung stem cells. 
Arumugaswami said in a UCLA news release
"Clinical trials have shown that Berzosertib blocks the DNA repair pathway in cancer cells, but has no effects on normal, healthy cells. For this reason, we think this drug shows great promise for treating COVID-19 patients and could be rapidly and safely be deployed in the clinic."

Song Li received $150,000 to help develop an injectable biomaterial that can induce the formation of T memory stem cells, which are important in generating an immune response. 

Li said that if his work is successful, it could have applications well beyond Covid-19. A summary of reviewer comment on his application (DISC2COVID) can be found here. 

Directors of the agency rejected six applications in their action on Friday. Summaries of all application reviews can be found here. 

The stem cell agency, which is running out cash, is now supporting 11 Covid-19 projects, including two clinical trials. The fast-track Covid round is accepting applications every two weeks. More awards are expected when agency directors meet again on June 26. 

The agenda at that time will include other matters such as the budget for the coming 12 months, including a wind-down schedule should voters reject a $5.5 billion ballot measure to refinance the agency, which is running out of money. 
  

Friday, June 12, 2020

California's $5.5 Billion Stem Cell Countdown: Total Now up to Nearly 540,000

California county elections officials have been tallying
signatures on stem cell initiative petitions for one month.


Nearly 27,000 signatures were added today as the $5.5 billion effort to rescue the California stem cell agency moved slowly towards an all-but-assured position on the November ballot

The proposed ballot initiative is aimed at saving the agency from its financial demise. The 15-year-old program is running out of cash and will begin closing its doors in the fall without more funds. 

Earlier this week, the California Stem Cell Report analyzed the trends in the tally, concluding that qualification is in the "virtual bag." 

Today's figures from state officials showed 537,558 
verified signatures of registered voters, up from yesterday's 510,930. The campaign is hoping for 685,534. The qualification rate is steady at about 78 percent. If the qualification rate stays fractionally above 67 percent, the measure will be placed on the ballot.  

Look for the next update on the count Monday evening or early Tuesday on the California Stem Cell Report, your only independent source of information and news about the stem cell agency for the last 15 years.

Thursday, June 11, 2020

California's $5.5 Billion Stem Cell Countdown: Campaign Not Likely To Sue for Deadline Extension

Solano County contributed 7,670 signatures this afternoon to the snail-like progress of a $5.5 billion stem cell research proposal towards a virtually assured position on the November ballot.

The measure is aimed at saving the California stem cell agency from fiscal extinction. The 15-year-old program is running out of cash and will begin closing its doors in the fall without more funds. 

Earlier this week, The California Stem Cell Report analyzed the trends in the count, concluding that qualification is in the "virtual bag." 

Today's figures from state officials showed 510,930 verified signatures of registered voters, up from yesterday's 
503,260. The campaign is hoping for 685,534. The qualification rate is steady at about 78 percent. If the qualification rate stays fractionally above 67 percent, the measure will be placed on the ballot.  

Only 14 counties out of 58 have not filed their verification numbers.

If the stem call initiative comes up short, it could join the effort to force the state to extend the deadline. Two groups have already sued seeking more time. One effort involves sports betting at Native American casinos. The other involves data privacy. The basic argument is that the Covid-19 crisis seriously and unexpectedly hampered the signature gathering which is constitutionally protected process. 

However, in response to a query, campaign spokeswoman  Sarah Melbostad today said,
"We have been pleased with the validity rates we’ve seen so far and are still confident that we are going to qualify for the November 2020 ballot. We have no plans to join these lawsuits or to file our own."

Look for the next update on the count tomorrow evening or early Saturday on the California Stem Cell Report, your only independent source of information and news about the stem cell agency for the last 15 years.

Wednesday, June 10, 2020

California's $5.5 Billion Stem Cell Countdown: Inching Towards November 3

San Francisco stepped up today to provide 10,900 signatures to help the California stem cell agency refinance itself through a $5.5 billion initiative that is headed for the November ballot. 

What's at stake is qualifying the proposal so that it will be presented to voters in the fall. Earlier this week, The California Stem Cell Report analyzed the trends in the count, concluding that qualification is in the "virtual bag." 

Today's figures from state officials showed 503,260 verified signatures of registered voters, up from yesterday's 492,349 . The campaign is hoping for 685,534. The qualification rate is steady at about 78 percent. If the qualification rate stays fractionally above 67 percent, the measure will be placed on the ballot.  

Only 15 counties out of 58 have not filed their verification numbers. For stem cell history buffs, San Francisco, once known as Baghdad by The Bay, also was once known as the home of the stem cell agency for a number of years. The city won the headquarters in a bidding war after it promised $18 milion, including 10 years in free rent. The agency moved to Oakland when the free rent ran out because of the high cost of office space in San Francisco.

California Gov. Gavin Newsom was then mayor of San Francisco and played a major role in reeling in the stem cell agency. He has not spoken publicly about whether he supports the $5.5 billion initiative. 

Look for the next update on the count tomorrow evening or early Friday on the California Stem Cell Report, your only independent source of information and news about the stem cell agency for the last 15 years.

Tuesday, June 09, 2020

California's $5.5 Billion Stem Cell Countdown: The Official Tally Creeps Towards the Certainty of November


Watching the Signature Numbers
* The campaign is seeking 110 percent of the
legal requirement of 623,212 to avoid going to a 
prolonged full check. Sources: Secretary of State
June 9, 2020,
California Stem Cell Report


The $5.5 billion initiative to save the California stem cell agency from its financial demise today made more slow progress in the official state count that is nearly certain to qualify it for the November ballot. 

The numbers already show that the measure is headed for the ballot unless something extremely unusual occurs. The California Stem Cell Report yesterday  analyzed the trends in the signature count, concluding that qualification is in the "virtual bag." 

Today's figures from state officials showed 492,349 verified signatures of registered voters, up from 484,973 on Monday. The campaign is hoping for 685,534. The qualification rate is steady at about 78 percent. If the qualification rate stays fractionally above 67 percent, the measure will be placed on the ballot.  

Only 16 counties out of 58 have not filed their verification numbers.

Look for the next update on the count tomorrow evening or early Thursday on the California Stem Cell Report, your only independent source of information and news about the stem cell agency for the last 15 years.
Editor's note: An earlier version of this item said Monday's count of verified signatures was 481,689, which is actually from Friday. The correct figure for Monday is 484,973.

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