Lake County Record-Bee

Prop. 14: In the COVID age, can California still afford its stem cell research program?

- 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 thenPresid­ent George W. Bush prohibited, on religious grounds, all federal funding of any stem cell research using human embryos.

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.

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.

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 ex

perts 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 de

stroyed 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 Institutef­unded 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.”

 ?? PHOTO COURTESY OF UC DAVIS HEALTH ?? Dr. Gerhard Bauer at the Good Manufactur­ing Practice (GMP) laboratory at UC
Davis Institute for Regenerati­ve Cures in Sacramento, where stem cell therapies are tested and produced.
PHOTO COURTESY OF UC DAVIS HEALTH Dr. Gerhard Bauer at the Good Manufactur­ing Practice (GMP) laboratory at UC Davis Institute for Regenerati­ve Cures in Sacramento, where stem cell therapies are tested and produced.

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