$5.5 Billion California Stem Cell Measure Holding Steady for Approval; Stem Cell Agency Set Today to Give Away $24 Million

 As directors of the $3 billion California stem cell agency are scheduled to meet later this morning, narrow voter approval of a ballot measure aimed at saving the agency's financial life is nearing a conclusion. 

The latest count by state election officials  at 8:18 a.m. PDT today continues to show Proposition 14 holding steady with 51.1 percent of the vote, a figure that has been virtually unchanged since last week. The percentage translates to 7.9 million votes. 

Negative votes are running at 48.9 percent or 7.6 million. State election officials are estimating that "unprocessed" ballots are running at 1.5 million. The figure is the latest from the state. H however, it is old, dating back to Tuesday at 6 p.m. PDT.

The agency is running out of the $3 billion originally provided by voters in 2004. Proposition 14 would provide the agency with $5.5 billion more over the next 10 to 15 years and make major changes in the agency, including a significant expansion in what it can fund.  The money would be borrowed by the state. No provision for funding the agency is provided after the money runs out again. 

The new ballot measure will not go into effect until after it is officially certified, which may not happen for another 28 days.

The meeting of the stem cell agency's board begins at 10 a.m. PDT today and is open to the public, including questions. Its agenda includes the award of as much as $21.7 million in clinical level grants and $2.5 million for basic research.  Several researchers have sent letters to the board appealing rejection of their applications by reviewers, who make the de facto decisions on the awards.

The meeting agenda also includes a proposal involving a possible loan to Viacyte, Inc., of San Diego. The agency has already pumped $52 million into the firm. Information on the meeting agenda concerning the loan is a bit laconic. The California Stem Cell Report has queried the agency for more details. 

Latest Prop. 14 Count: 51.1 Percent Yes, 48.9 Percent No

As of 7:05 a.m. PDT today, the count for Proposition 14, the $5.5 billion California stem cell measure, stands at 51.1 percent for and 48.9 percent against. It is not clear when election officials will stop counting, but certification is required within 30 days.  An estimated 2.7 million votes remain to be counted, according to election officials. 

Vote Margin Tightens on California Stem Cell Measure

California Secretary of State graphic

The margin of approval for California's $5.5 billion stem cell ballot measure has narrowed very slightly with the latest figures showing 51 percent of voters in favor, down from 51.1 percent last week. 

The "semi-official" vote count at 9:08 a.m today from the Secretary of State's office tallied 7,085,881 (51.0 percent) in favor of Proposition 14 and 6,802,604 against (49 percent). State election officials, however, did not have a count for the number of all outstanding ballots, as of last night.

The total number of ballots reported cast at this point is about 13.9 million. About 22 million persons are registered to vote. A significant percentage of those are not expected to have voted at all. Many vote only on races important to them, such as the presidential contest. Still others simply don't work their way through the ballot to the propositions. 

Some readers may ask: Is it a possibility that Proposition 14 could ultimately lose in the official, certified count that is not due until December? The answer is the usual one for questions of possibilities: Anything is a possibility. 

However, at this stage in the count, it is more likely than not that the remaining outstanding votes will break in the pattern already established, with Proposition 14 being approved.  But, as noted, anything is possible.

Regarding the map below, it is a static version of the one on the Secretary of State's site. Red indicates counties that did not support Proposition 14. If you click on this sentence, the link will take you to an interactive version that opens up each county.  

Prop. 14 Campaign Says Race Still Too Close to Raise Victory Flag for $5.5 Billion Measure

California voters have apparently approved spending $5.5 billion more on stem cell research over the next 10 to 15 years and significantly broadening the scope of its state stem cell agency, according to unofficial figures this morning. 

The refinancing of the agency, officially known as the California Institute for Regenerative Medicine (CIRM), was approved by 51.1 percent of the voters compared to 48.9 percent against, with 99 percent of the votes in, state election officials reported. 

(However, a spokeswoman for the Proposition 14 campaign said following publication of this item that the vote is too close to call. "There are at least 4 or 5 million votes that still need to be counted, she said.) 

CIRM was created by voters in 2004 who also provided it with $3 billion in borrowed money. However, the cash began to run out last year, and staffers were leaving. The Oakland-based agency was planning to begin closing its doors this winter in the event that Proposition 14 was not approved. 

Approval of Proposition 14 means the revival of an enterprise that is unique in California history and in the nation. No other state has mounted a stem cell program on the scale of CIRM. Voters 16 years ago endorsed it with 59 percent of the vote following a campaign that raised optimistic expectations that stem cell cures were right around the corner. 

However, CIRM has not financed a stem cell therapy that is widely available to the general public. It is helping, however, to finance 64 clinical trials.  

In addition to providing $5.5 billion in state bonds, Proposition 14 authorizes CIRM to expand its operations into such areas as mental health, therapy delivery and "aging as a pathology." Its 29-member board will be expanded to 35, raising the likelihood of more conflicts of interests involving the board. 

An analysis this summer by the California Stem Cell Report showed that 79 percent of the agency's awards have gone to institutions with links to members of the CIRM board. The board members cannot vote on awards to their specific institutions. But they vote on and can change award "concept" programs that can benefit their institutions. 

In 2012, a $700,000 evaluation of CIRM, commissioned by the agency itself, recommended a major restructuring of CIRM and was critical of the conflict of interest issues posed by its structure. Proposition 14 does little to address those recommendations from the prestigious Insitute of Medicine. 

The 2004 ballot initiative also deliberately structured CIRM to avoid oversight by the governor and legislature. Funds flow directly to CIRM without requiring legislative approval. 

The immediate task now facing the agency is to adopt a new strategic plan for spending the $5.5 billion and hiring additional staff. The number of its employees dwindled to 33 this summer, down from a high of 56. 

The CIRM board yesterday scheduled a public, online meeting for Nov. 12. Its agenda currently does not include approval of the new strategic plan that its CEO Maria Millan and CIRM staff have been devising. 

Proposition 14 also could mean the removal of some board members whose terms are 50 percent expired. But that would depend on the pleasure of the appointing authorities. 

Prop. 14 Ballot Results: Narrow Lead for the $5.5 Billion Measure

Proposition 14, the $5.5 billion California stem cell measure, is winning approval from about 52 percent of voters with slightly over half of the state's precincts reporting. 

But the margin is too small to declare a win for supporters of the measure. Look for an update on the vote early tomorrow morning (Wednesday). 

Voting on Proposition 14

(10:25 p.m. PDT)

Geographic Area	Percentage Yes	Percentage No	Percentage of Precincts Reporting
Statewide	52.0	48.0	50.3
Los Angeles County	52.5	47.5	NA
San Diego County	54.1	45.9	NA
Orange County	48.9	51.5	NA
Riverside County	49.5	50.5	29.0
San Bernardino	50.2	49.8	NA

Election Results Prop. 14: Returns are Mixed and Very Preliminary

Early returns on voting on Proposition 14, the $5.5 billion California stem cell measure, are mixed and too preliminary to make firm conclusions about its fate. The counties listed are the five most populous in the state. Polls closed at 8 p.m. PDT.

These early returns do not necessarily indicate the final result, which may not be known for days, depending on how close the margin is.

Voting on Proposition 14

Geographic Area	Percentage Yes	Percentage No	Percentage of Precincts Reporting
Statewide	51.3	47.57	2.2
Los Angeles County	54.9	45.10	NA
San Diego County	54.26	45.74	NA
Orange County	48.85	51.5	NA
Riverside County	49.81	50.18	26
San Bernardino	NA	NA	NA

Prop. 14 Narrrowly Leading in Extremely Early Returns

Voting on Proposition 14

Early returns on voting on Proposition 14, the $5.5 billion California stem cell measure, showed that the measure was running ahead with  the state's voter. The counties listed are the five most populous in the state. Polls closed at 8 p.m. PDT.

These early returns do not necessarily indicate the final result, which may not be known for days, depending on how close the margin is. 

Geographic Area	Percentage Yes	Percentage No	Percentage of Precincts Reporting
Statewide	51.3	48.7	2.2
Los Angeles County	NA	NA
San Diego County	NA	NA
Orange County	NA	NA
Riverside County	NA	NA
San Bernardino	NA	NA

Looking for Results on the $5.5 Billion Stem Cell Measure in California? Find Them Right Here

The California Stem Cell Report will carry results tonight on Proposition 14, the $5.5 billion stem cell research ballot initiative, beginning shortly after 8 p.m. PDT. 

The mainstream media will be focused on other races that will go unmentioned here. The California Stem Cell Report, however, will be digging into the returns most of the evening and will bring Proposition 14 results to you right here on this site both tonight and again tomorrow morning.  

Prop. 14: California Voters Like Bond Measures Most of the Time -- At Least in the Past

If the past is any guide, the $5.5 billion ballot measure to rescue the state of California's stem cell program from financial extinction is likely to win approval today from voters.

Golden State voters have been generous with bond measures since 1986, approving them more than a majority of the time in statewide elections. 

According to figures compiled by the state's Legislative Analyst, 67 bond measures on statewide ballots have been approved in the last 34 years. Twenty-seven were rejected. 

That said, considerable caveats abound. These are not ordinary times.  

The state is reeling from wildfires, severe economic disruption, Covid-19, overstretched local and state budgets not to mention pandemic fatigue. 

And just how all that will translate to action on Proposition 14, the stem cell ballot initiative is unclear. No polls have been published on the measure, which has been eclipsed by much higher profile measures, not to mention the presidential race. 

But it could well be that the public wants more certainty in terms of medical care and cures, which the backers of Proposition 14 promise.

"Proposition 14 continues vital funding to find treatments and cures for life-threatening diseases and conditions that affect someone in nearly half of all California families – such as cancer, Alzheimer’s, and diabetes," says the campaign website.

"Stem cell research is restoring health and improving lives in California," the site says.

Oddly enough the heavy promotion in past years of snake-oil "stem cell" therapies may well benefit the measure. Everybody loves miracles. And significant segments of the public do not distinguish between legitimate and illegitimate medical claims.

That said, it could cut the other way as well, with some voters thinking Proposition 14 is a close cousin of the rogue "stem cell" clinics, which number in the hundreds across California and are almost totally unregulated. 

Election results are likely to be slow to surface this evening after polls close at 8 p.m. PDT. The mainstream media will be focused on other races that will go unmentioned here. The California Stem Cell Report, however, will be digging into the returns most of the evening and will bring Proposition 14 results to you right here on this site both tonight and again tomorrow morning. 

****

​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.

Prop. 14: USA Today Looks at UCLA Gene Therapy and California's Stem Cell Program

The Lagenhop family in Los Angeles for a clinical
trial to treat their children for a fatal affliction
Harrison Hill/USA Today photo

USA Today has published a lengthy piece involving initial, favorable results from a more than $12 million clinical trial backed by the California stem cell agency and involving a rare disease that usually ends the lives of children before they reach kindergarten age.

The article comes on the eve of the final day for voting on a ballot initiative, Proposition 14, to save the agency from financial extinction by giving it $5.5 billion more. Officially known as the California Institute for Regenerative Medicince (CIRM), the 16-year-old agency is running out of its original $3 billion and is scheduled to begin closing its doors this winter without a boost from the initiative.

The research involves three children from Ohio who are being treated at UCLA in a trial being conducted by Donald Kohn, who has performed other genetic therapy procedures for rare diseases. For the work, CIRM awarded Rocket Pharmaceuticals, Inc., a publicly traded, New York-based firm, $6.6 million in May 2019. The firm provided co-funding of $5.6 million. (Here is a link to the summary of the review of the application, CLIN2-11480.)

Over the years, CIRM has supported Kohn's work with $52 million, not including the Rocket funding. 

The USA Today article by Karen Weintraub began with the case of the family of Alicia and Jon Langenhop of Canton, Ohio. The piece delved into the history of the California stem cell program, but did not mention the agency or its official name.  Proposition 14 was mentioned twice, once in the headline. 

USA Today is a national newspaper. Circulation figures for California are not available, although it reports national, weekly circulation of 726,906. Today's story, which would resonate with many voters, was tucked away in its health section.  

The affliction involved is Leukocyte Adhesion Deficiency-I (LAD-I. 

"Patients with severe LAD-I can develop life-threatening infections because their white blood cells are unable to leave the bloodstream to fight them. Without a successful bone marrow transplant, severe LAD-I is most frequently fatal during the first 2 years of life," the Rocket web site said.

The company's stock price today closed at $28.74, up 70 cents. Its 52-week high is $30.43, and its 52-week low is $9.01. 

USA Today quoted some researchers as saying taxpayer spending has put the Golden State in "the forefront of global stem cell research." The article said, 

"George Daley, a stem cell biologist who is dean of Harvard Medical School, said he's envious of the California researchers who have access to this pot of money.

"'California has always been a very exciting place to pursue science, but prior to (the taxpayer funding), it wasn't exactly the place that was the first on the tip of your tongue as a powerhouse community for stem cell science,' he said. 'But there's no way that today it wouldn't be listed in the top three.'"

****

Read all about California's stem cell agency, including Proposition 14,  in David Jensen's new book. Download it from Amazon:  California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures. Click here for more information on the author.

Prop. 14 in the Media: Supporters Plugging Away with Opinion Pieces

The ballot measure to rescue the California stem cell agency with $5.5 billion drew a few more opinion articles of support online this weekend as the opposition to Proposition 14 continued to be all but invisible. 

Supporters, however, are not likely to rest easy during the next two days. As the sponsor of the measure, Palo Alto real estate developer Robert Klein, has remarked, the impact of Covid-19 on voters, with all its economic and emotional ramifications, is the biggest question mark involving approval of Proposition 14.

The campaign has attracted little news coverage in the media with the exception of one-off pieces. No polls have been taken on the proposal, which would send the state stem cell agency into new areas that go well beyond the direction of the agency since 2004, when it was created. The agency was provided with $3 billion at the time but is scheduled to begin closing its doors this winter as the funds run out.

Here is a rundown on articles by supporters that have appeared in recent days.

Don Reed, a patient advocate and longtime supporter of the agency, continued with a parade of items on his blog, Stem Cell Battles. The most recent focused on hearing loss work at Stanford by Alan Cheng, who has received $4.5 million from the stem cell agency, officially known as the California Institute for Regenerative Medicine (CIRM).

Reed quoted Cheng as saying, 

“We see regrowth of hair cells in the mouse balance organs — and the balance function appears to improve, according to how many hair cells come back.” 

Writing on online on IVN was Alysia Vaccaro, who said, 

"In 2012, when my daughter Evangelina, “Evie,” was just six weeks old, she was diagnosed with severe combined immunodeficiency (SCID). More commonly known as “bubble baby” disease, the rare genetic disorder left her at risk of death from any infection, even a diaper rash or the common cold. Born alongside a healthy twin, we were told Evie would likely not make it to her second birthday.

"However, thanks to Proposition 71 in 2004, California voter’s initial investment in stem cell research and the California Institute for Regenerative Medicine, a groundbreaking treatment was discovered at the University of California Los Angeles that saved my daughter’s life and 49 other babies born with the same rare disease – giving them all functioning immune systems and a second chance to live a long, healthy life."

Larry Goldstein, a UC San Diego researcher who has received $21.5 million from CIRM, wrote on the Times of San Diego, 

"A yes vote on Proposition 14 is crucial to continue the pace of medical research and our state’s journey to save lives. For millions of Californians who live with a chronic disease or condition, and who need new therapies, this may be their last hope.....There is a glaring funding gap between early lab work and late-stage clinical trials — known as “The Valley of Death” — that often ends promising stem cell research."

**** 

​Read all about California's stem cell agency, including Proposition 14,  in David Jensen's new book. Download it from Amazon:  California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures. Click here for more information on the author. 

Prop. 14 News Coverage: Los Angeles Times and Politico Take a Crack at the Stem Cell Measure

A $5.5 billion ballot measure to save the California stem cell agency from financial extinction popped up in coverage this week in the Los Angeles Times and Politico, a national political and government news service. 

Both pieces raised questions about the agency and its history, not to mention whether it fits with California's current government priorities.

The proposal is Proposition 14. It would provide the billions to the agency,  expanding its scope significantly into such areas as mental health and therapy delivery that are not necessarily related to stem cells. 

In his piece, George Skelton, a longtime political columnist for the Times, the largest circulation newspaper in the state, noted that the agency was funded in 2004 with $3 billion, which is now running out. Skelton wrote, 

"That’s a ton of money for a little-noticed agency that provides a questionable state service. But many of the research projects have been very worthwhile." 

In the article, the Proposition 14 campaign, headed by Palo Alto developer Robert Klein, also continued its pattern of making exaggerated or misleading claims.  

"If we don’t continue the state funding, lots of facilities would have to close their doors,” says Kendall Klingler, the Proposition 14 spokeswoman....

"'We have more than 90 stem cell trials underway,' she says.

"The agency does have a record of some success: funding research that has led to treatments approved by the Food and Drug Administration (FDA) for blood and bone marrow cancers, for example."

Regarding the number of clinical trials funded by the research program, the agency itself only claims 64. The additional 30 or so trials are not funded by the California Institute for Regenerative Medicine (CIRM), as the agency is officially known. They utilize a piece of CIRM-financed research, however tiny, someplace along the way. And not necessarily a significant piece. 

The FDA treatments mentioned are not stem cell treatments, which is what was promised by the 2004 campaign. The agency has not funded any research that has resulted in a stem cell therapy that is available to the general public. 

And it is simply not accurate to say that "lots" of stem cell facilities partially financed with CIRM cash will be closing. All of them are occupied and fully in use. The recipients of the facilities grants, such as Stanford and UC San Francisco, are exceedingly unlikely to close the buildings.

Skelton concluded that CIRM has "failed to live up to its original hype." He said, 

"It was aloof to Sacramento, and not subject to oversight by the Legislature and governor. There’s been a lack of transparency.

"There was also an odor of interest conflicts among agency board members who seemed to steer grants toward their own institutions, even though they recused themselves from voting."

(In the interest of full disclosure, I worked for Skelton in the Capitol bureau of United Press International in the 1970s when he was bureau chief there.)

Over at Politico, Victoria Colliver wrote,  

"It's not clear that the Yes on 14 campaign's $15 million, even with a campaign that features actor Seth Rogen as “Stemmy the Stem Cell," will get the job done.

"'We’re running against Covid-19. That’s our real opposition,” said Robert Klein, the wealthy real estate investor and attorney who authored both measures and is the main funder of Prop. 14, along with Dagmar Dolby, the widow of inventor and sound engineer Ray Dolby.

"The differences between 2004 and 2020 are stark.

"Back then, Klein and other proponents had a ready-made argument by pointing to President W. Bush's prohibition on federal funding for embryonic stem-cell research, a stance supported by the religious right. In the nation's biotech capital — with an electorate dominated by Democrats and independent voters that support abortion rights — stem-cell backers made the case that California needed to step in to keep research alive.

"Many of the promises made 16 years ago, including its projections in royalties and state revenues from new treatments, have not borne out. Funding from the agency has supported more than 60 clinical trials, but CIRM has yet to fund a single stem-cell therapy approved by the U.S. Food and Drug Administration for widespread use."

Prop. 14 News Coverage: Campaign Chicken Feed and Editorials

The Biopolitical Times this week briefly explored campaign spending on Proposition 14, newspaper editorials and opposition to the $5.5 billion stem cell research measure on this fall's California ballot.

The piece by Pete Shanks, who has followed the state stem cell agency for a number of years and opposes the measure, called the $18 million spent on behalf of Proposition 14 "almost modest." It is actually chicken feed compared to the more than $700 million spent so far on California on all ballot propositions.

Indeed, the $18 million is smaller than many grants from California's stem cell agency, which would be refinanced and significantly expanded under Proposition 14. A substantial number of the agency's grants run about $20 million. 

Several years ago, Robert Klein, the Palo Alto real estate developer heading the campaign, told the California Stem Cell Report that the effort would cost $50 million. However, the more modest $18 million may be the product of a difficult fundraising environment this year rather than reflecting what is needed to win approval of the measure. Or it could be a lack of enthusiasm among potential major donors.  

Known officially as the California Institute for Regenerative Medicine (CIRM), the agency is scheduled to begin closing its doors this winter without a substantial infusion of cash.

Shanks also tallied up newspaper editorials on Proposition 14 and said, "Overall, the  'NO' publications seem far more impressive." Many of the major newspapers in the state oppose the measure, including the Los Angeles Times, the state's largest circulation newspaper. The San Francisco Chronicle, which spent months in 2018 analyzing the operations of the stem cell agency, also opposed Proposition 14. 

Shanks noted that Zach Hall, the first president of the agency, says the agency has served its purpose and no longer is needed. The California Stem Cell Report on Monday first reported Hall's position. 

The Biopolitical Times is produced by the Center for Genetics and Society in Berkeley, Ca., which opposed creation of the stem cell agency in 2004.  

*****

Read all about California's stem cell agency, including Proposition 14,  in David Jensen's new book. Download it from Amazon:  California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures. Click here for more information on the author.

Proposition 14: The Latest News and Opinion, STAT to Capitol Weekly

The national biomedical news service STAT today took a look at California's $5.5 billion stem cell measure, declaring it was backed by a "well-financed campaign that’s making heady promises about curing diabetes, paralysis, cancer, and Parkinson’s and Alzheimer’s diseases."

The headline on the story by Usha Lee McFarling said,

"With wildfires burning and Covid-19 spreading, can California afford stem cell research? Voters are set to decide"

McFarling's story was one of the more detailed that have appeared so far either nationally or within California.

She had this observation from a Los Angeles specialist on ballot initiatives, which is the direct democracy tool that Robert Klein, a Palo Alto real estate developer, used to place Proposition 14 on the ballot.

"John Matsusaka, an economist who heads the Initiative and Referendum Institute at the University of Southern California. He said federal funding restrictions that fueled support of Proposition 71 are no longer a major concern, proponents have not done a great job demonstrating that voters got their money’s worth from the first $3 billion, and the measure is coming to voters during tough fiscal times." 

In 2004, Proposition 71, also created by Klein, established the state stem cell agency, known officially as the California Institute for Regenerative Medicine (CIRM), and provided it with $3 billion. The money is nearly gone.  CIRM is set to begin closing its doors this winter unless Proposition 14 is approved. 

Mentioned or quoted in the STAT story were Alan Trounson, former CEO of CIRM, researchers Larry Goldstein of UC San Diego, Irv Weissman of Stanford, Jeanne Loring of Aspen Neurosciences, Inc., Andy McMahon of USC, and Jan Nolta of UC Davis. Others included CIRM governing board members Joe Panetta and Jeff Sheehy, and Melissa King, executive director of Americans for Cures and the head of field operations for the campaign group "Yes on 14." 

The STAT piece dealt with the range of pro and con arguments, including conflicts of interest. 

"'The people who decide who is going to get funded are the people who get funded. That’s a built-in conflict of interest they made no attempt to fix,' said John Simpson, who monitored CIRM for many years as stem cell project director for the group Consumer Watchdog. 'They need to go back to the drawing board and fix these structural flaws.'"

"Some of the conflicts have been so flagrant as to be almost comical. For example, former CIRM President Alan Trounson once asked prominent biochemist Leroy Hood to be a reviewer of a grant by Irv Weissman, the director of Stanford’s Institute for Stem Cell Biology and Regenerative Medicine, after the three men spent time fly fishing together on a Montana ranch jointly owned by Weissman and Hood."

Also appearing today was an opinion piece on the Capitol Weekly online news service by Pete Shanks, who has written about CIRM for years on the blog, Biopolitical Times. 

He cited the much-discussed issues surrounding the stem cell agency and wrote 

"Proposition 14 could have addressed these defects. Instead, it made them worse: It enlarges the board to 35 members, still mostly drawn from representatives of the universities, companies, and research institutes that receive its grants."

Shanks also said, 

"The 2004 proposition campaign has been widely criticized for hype: over-promising the imminence and certainty of breakthroughs. The advocates called their operation 'Cures for California,' but these have been in short supply. They also said that stem cell research would enormously reduce California’s medical costs, but there’s no sign of that.

"The campaign for Proposition. 14 follows the same pattern. It claims that the new multibillion-dollar investment has 'massive savings potential' and a 'low impact' on the budget. Skepticism is definitely in order."

*****

​Read all about California's stem cell agency, including Proposition 14,  in David Jensen's new book. Download it from Amazon:  California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures. Click here for more information on the author. 

Proposition 14: First CEO of California Stem Cell Agency Says $5.5 Billion Stem Cell Measure Not Needed

Zach Hall, UCSD photo

The first president of the California stem cell agency, Zach Hall, says that he would vote against the $5.5 billion ballot measure to save the research enterprise from financial extinction if he still lived in California.

Hall, now retired and living in Wyoming, says a justification for agency existed in 2004 when it was created by voters via another ballot measure, the $3 billion Proposition 71. 

But, according to the new book, "California's Great Stem Cell Experiment," Hall says "that the rationale and need are not so evident today for a state-supported agency dedicated to stem cell research."  

The creation of induced pluripotent stem cells has largely supplanted the use of cells derived from embryos, Hall said. The Bush Administration restrictions on human embryonic stem cell research were major drivers for Proposition 71, but those have now been lifted.

Hall said that the National Institutes of Health could likely support most of the stem cell work that is now backed by CIRM.

Proposition 14, the $5.5 billion ballot initiative, would refill the stem cell agency's coffers. The program is running out of the $3 billion provided in 2004 and will begin  closing its doors this winter without major funding. 

Hall was president and CEO of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, from 2005 to 2007 and drew up the agency's first strategic plan. During his long career, Hall was also director of the National Institute of Neurological Disorders and Stroke in the 1990s, executive vice chancellor at UC San Francisco, CEO of En Vivo Pharmaceuticals and a director of the New York Stem Cell Foundation.

Interviewed for the book, which was authored by this writer, Hall said that he has no regrets about serving as its first president, a job he largely enjoyed. 

Hall said that Proposition 71 of 2004 served an important and useful purpose. It helped to re-energize the stem field at a time when it was “disheartened and demoralized” by the restrictions of the Bush Administration.

While the 2004 measure had significant flaws, he said it was very successful at a critical time in attracting stem cell researchers to California.

“The idea that California would make this sort of commitment, I think, had a huge impact on the field,” Hall said.

 “It's certainly true that because of Proposition 71 that California continues to play a stronger role in stem cell research than it otherwise would have. But, contrary to some expectations, it is not the center of the universe of stem cell research in the same way that Silicon Valley is for information technology.

“It is one of many global centers of excellence for stem cell research. One perhaps naïve expectation that has not been met is an explosion of profitable California biotech companies specializing in stem cell research.”

Hall said, however, that Proposition 14 “is searching for a rationale to continue CIRM.” Hall mentioned the “amorphous” research avenues provided for in the measure: mental health, personalized medicine, “aging as a pathology” and “vital research opportunities.”

“You can use the money for almost anything,” Hall said. “This takes off a lot of the brakes on how the money can be spent.”

Given what has been learned over the last 15 years, he said he would have thought a new initiative would have attempted to improve governance and try to make CIRM work better, be more efficient and more strategic. “There's just no sense of thoughtfulness of using the expertise of getting relevant people together to think about it and come up with a plan,” Hall said.

He also said that Proposition 14 does not provide a good or transparent mechanism for making decisions about how the money is going to be spent.

“My guess is that all the board positions will be filled by constituents, people who depend on CIRM money in some way and who will be very pliable about what is to be done. Exactly the wrong way to do it.”

The California Stem Cell Report asked Hall last week if he would like to add anything to his earlier comments for the book. "One thought I might add," he replied, "concerns the idea that Proposition 14 will address the issue of the 'Valley of Death', i.e. the gap between discovering a possible therapeutic and being able to 'de-risk it' enough to attract the interest of big pharma.  What is being proposed, it seems, is that CIRM wants to act as a kind of VC (venture capitalist) with the state's money.  

"In my view, a much better approach to this problem is to find ways to encourage academic and industry scientists (both biotech and big pharma) to work together starting from an early stage of the work. This has been done effectively (and much more cheaply!) by several private philanthropic organizations.  The Michael J. Fox Foundation and Target ALS are two examples that I know of."