In 2004 California ballot measure Proposition 71 was passed, granting $3 billion ($6 billion including interest) in state funds to support politically controversial embryonic stem cell research in California at a time when the federal government was restricting this research. A public agency was established, the California Institute for Regenerative Medicine, to dole out this money across California universities, medical research institutions and biotech companies. During the election campaign, California voters were assured of breakthroughs and cures for conditions like Parkinsons and spinal cord paralysis through celebrity endorsements featuring actors, Nobel prize winners and other notables. Prop. 71 money is dwindling and there is talk about putting a $5 billion renewal initiative on the ballot. So its reasonable to ask what California taxpayers got out of this deal over the past 13 years. Sadly, CIRM hasnt generated a single approved medical treatment. Through September 2016, CIRM has funded only three stem cell research projects that have reached Phase 3 clinical trials (the final step before FDA marketing approval). One of these trials was terminated and the other two are still recruiting patients and are not expected to report out for several years. During the same time, despite embryonic stem cell research restrictions, the federal National Institutes of Health has funded 50 stem cell research projects in Phase 3 trials. The NIH cost per Phase 3 research trial has been five times lower than the state program. Nearly half of the state funding has gone to research infrastructure rather than to actual research.

There also appears to have been blatant conflicts of interest in CIRM research awards. Around 80 percent of CIRM grants have gone to institutions represented on its board of directors. One out of seven CIRM research dollars has gone to Stanford University. One awardee, StemCells Inc., was co-founded by Irving Weissman, Stanfords stem cell program director. StemCells received at least $40 million from CIRM before going belly up. The CIRM board initially turned down a $20 million funding proposal to StemCells, until Bob Klein, the Northern California real estate investor who drafted Prop. 71 and was the first chairman of CIRMs governing board, was reported to have pressured the board to reverse that decision. CIRMs President Alan Trounson abruptly resigned in October 2013, joined the board of StemCells one week later, and then received $435,000 in cash and stocks from them before the company folded last year.

Does it make sense for California taxpayers to fund biotechnology research? Perhaps. A good case can be made that public investments in basic biotechnology infrastructure can have enormous benefits to Californias economy and job growth while generating significant improvements in human health. But public funding should have broader scope and flexibility to go after all promising new technological advances, not just current scientific fads or political controversies. Public funds should be awarded with rigorous oversight and accountability. There should be a sharp line between basic research, which requires public funding and is unlikely to yield short-term tangible cures, despite what celebrity actors say, and getting new medicines to market. Promising new treatments are already well-funded through private venture capital funds and biotech companies, who are much better at picking winners and losers than California taxpayers.

By not providing adequate oversight over potential conflicts of interest and not holding CIRM funding recipients to the same rigorous standards as NIH grant recipients, CIRMs 13 year record of zero new medicines for $6 billion in taxpayer funds is not an experiment that the voters should regenerate at the ballot box.

Joel W. Hay is a professor of Health Economics and Policy at the University of Southern California.

Originally posted here:
Regenerating medical research payouts? - OCRegister