Monday, October 26, 2020

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." 

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