By Barbara Feder Ostrov | CalMatters
For the second time in 16 years, California voters will decide the fate of the state’s multi-billion dollar stem cell research program that established the state as a worldwide leader.
How the times have changed.
In November, as the pandemic drags on, Proposition 14 asks voters to spend nearly $8 billion to continue the program during a period when the research environment has significantly evolved and coronavirus has battered the state’s budget.
The bond measure would approve $5.5 billion in bonds to keep the state’s stem cell research agency running and grants flowing to California universities and companies.
At least $1.5 billion would be earmarked for brain and central nervous system diseases like Alzheimer’s and Parkinson’s. The overall cost of the bonds and their interest totals about $7.8 billion, according to the state legislative analyst. The state would pay about $260 million annually for 30 years, or about 1 percent of California’s annual budget.
Proposition 14 is essentially a repeat— with a bigger price tag and a few tweaks – of Proposition 71, which California voters approved in 2004 after then-President George W. Bush prohibited, on religious grounds, all federal funding of any stem cell research using human embryos.
The institute has nearly used up its original funding, so Prop. 71’s author, real estate investor and attorney Robert N. Klein II, led a new effort to get Prop. 14 on the November ballot. That groundbreaking measure authorized $3 billion in state bonds to create the state’s stem cell research agency, the California Institute for Regenerative Medicine, and fund grants for research into treatments for Alzheimer’s disease, cancer, spinal cord injuries and other diseases.
This time, embryonic stem cell research is in a much different place, with federal funding no longer blocked and more funding from the biotech industry.
Voters will want to consider what California’s previous investment in stem cell research has accomplished. It’s a nuanced track record.
While many scientific experts agree that Prop 71 was a “bold social innovation” that successfully bolstered emerging stem cell research, some critics argue that the institute’s grantmaking was plagued by conflicts of interest and did not live up to the promises of miracle cures that Prop. 71’s supporters made years ago. Although the agency is funded with state money, it’s overseen by its own board and not by the California governor or lawmakers.
The agency had “done a very good job” of setting priorities for stem cell research, including research using human embryos, and doling out $300 million annually to build up California as a regenerative medicine powerhouse, according to a 2013 evaluation by the National Academies of Science, Engineering and Medicine.
But the report also found that because the institute’s board is made up of scientists from universities and biotech firms likely to apply for grants, board members had “almost unavoidable conflicts of interest.”
Because human stem cells can develop into many types of cells, including blood, brain, nerve and muscle cells, scientists have long looked to them for potential treatments for currently incurable diseases and injuries. Researchers use two types of stem cells: embryonic stem cells, derived from unused human embryos created through in vitro fertilization, and adult stem cells, which are harder to work with but in some cases can be coaxed in a lab into behaving more like embryonic stem cells.
From the start, stem cell research has been ethically charged and politically controversial because human embryos are destroyed in some types of studies. Federal restrictions on the research have waxed and waned, depending on which political party holds power. While former President Bush restricted federal money for embryonic stem cell research, former President Obama removed those restrictions.
The Trump administration has restricted government research involving fetal tissue but not embryonic stem cells. However, anti-abortion lawmakers have called on the President to once again end federal funding for embryonic stem cell research.
California-funded research has led to one stem cell treatment for a form of Severe Combined Immunodeficiency known as the “bubble baby” disease. Children with the rare disease don’t make enough of a key enzyme needed for a normal immune system. Without treatment, they can die from the disease if not kept in a protective environment. The U.S. Food and Drug Administration is now reviewing the treatment but has not yet approved it for widespread use.
Although many of the agency’s early grants were for basic science, the institute also has supported 64 clinical trials of treatments for many types of cancer, sickle cell disease, spinal cord injuries, diabetes, kidney disease and amyotrophic lateral sclerosis, commonly known as Lou Gehrig’s disease.
A June 2020 analysis by University of Southern California health policy researchers estimated that taxpayers’ initial $3 billion investment in the research institute helped create more than 50,000 jobs and generated $10 billion for the state’s economy.
Gov. Gavin Newsom has endorsed Proposition 14, and other supporters include the Regents of the University of California, the California Democratic Party, the Juvenile Diabetes Research Foundation, patient advocacy groups like the March of Dimes, and some local politicians and chambers of commerce.
Supporters have raised more than $8.5 million, including about $2 million from billionaire Dagmar Dolby, to pass the measure, according to California Secretary of State campaign finance reports.
“The passage of Proposition 71 helped save my life,” Sandra Dillon, a blood cancer patient, wrote in a San Diego Union-Tribune commentary supporting Proposition 14. She wrote that she had benefited from a drug developed with Institute-funded research that has been designated by the FDA as a “breakthrough therapy.”
“It is unimaginable to think that Californians would vote to discontinue this amazing effort — I don’t know where I would be or what condition I would be in if it wasn’t for the investment Californians made nearly two decades ago.”
Lawrence Goldstein, a UC San Diego professor of cellular and molecular medicine and stem cell researcher, said the grants were instrumental in furthering his research on treatments for Alzheimer’s disease and that Prop. 14 will help create new jobs. The agency has “funded a great deal of very important stem cell medical research that’s already produced terrific results and has the prospect of saving many more lives in the decade to come,” he said.
Opponents include one member of the institute’s board and a nonprofit that advocates for privacy in genetic research. They contend that the proposition seeks too much money and does not sufficiently address the conflicts of interest that cropped up after Prop. 71 was passed. They also note that private funding, including venture capital, for stem cell research has grown in recent years. Opponents had raised only $250 by late September, from a single contribution by the California Pro Life Council.
The editorial boards of some of California’s biggest newspapers also have opposed the measure, including the Los Angeles Times, the Orange County Register, the San Francisco Chronicle and the San Jose Mercury News/East Bay Times. The Fresno Bee, Modesto Bee, and San Luis Obispo Tribune newspaper editorial boards support Prop 14.
Jeff Sheehy, the only institute board member not to support Proposition 14, told CalMatters that the research environment has changed since voters initially approved state funding for stem cell research in 2004 and that California should prioritize other needs like education, health care, and housing.
“I think the agency’s done good work, but this was never planned to be funded forever with debt,” Sheehy said. “At this point the state can’t afford it; we’re looking at a huge deficit.”
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