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. 

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