Wednesday, November 06, 2019

Skeptical Look at $5.5 Billion Plan to Refinance California's Stem Cell Research Program

A longtime critic of California's $3 billion stem cell agency this week chalked up pluses and minuses of the research effort, which it said is "essentially broke," and sounded a skeptical note about a plan to refinance it with $5.5 billion more.

The Center for Genetics and Society (CGS) "essentially" agreed with what it described as a "scorching" critique of the proposed ballot initiative to provide the agency with additional billions. In addition to the cash, the initiative would make major changes in the California Institute for Regenerative Medicine (CIRM), as the agency is formally known.

In a post on the CGS blog, Pete Shanks, a consultant with the Berkeley organization, briefly recounted the history of CIRM and some of the past criticism of it. But he focused primarily on the critique last week by longtime CIRM board member Jeff Sheehy. Shanks said,

"Sheehy’s range of concerns is wide. He convincingly criticizes proposed changes in the board structure, in handling conflicts of interest, and in the way CIRM addresses ethical concerns. He objects to the measure’s failure to maximize financial returns to the State from any successful therapies. He is also apparently baffled by the strange requirement that CIRM must expand its (apparently successful) 'Alpha Stem Cell Clinical Program' — seemingly a clear example of fixing what ain’t broke."
Shanks also wrote,
"The original governance scheme of CIRM has been widely criticized, first at the time of its formation by a number of public interest organizations (including the Center for Genetics and Society) and subsequently by the Little Hoover Commission in 2009 and by the Institute of Medicine in 2012.”
He continued,
"One of the main criticisms of CIRM involved widespread conflicts of interest on its governing board and the lack of effective oversight from the legislature, both of which were built into the structure quite deliberately. The proposition amended the California Constitution by specifically adding the establishment of CIRM and the right to conduct stem cell research as Article XXXV . It also required waiting at least three years, obtaining votes from a 70 percent supermajority of both houses of the Legislature, and the Governor’s signature before any amendment could be made. And it exempted the research it authorizes from “other current or future state laws or regulation.” Unfortunately, the new language not only avoids making many needed reforms, but it may also actually make the structural issues worse."
Shanks noted the hype surrounding the 2004 initiative that created CIRM. He said,
“Advocates for the new initiative have already demonstrated that they plan to pin their case for billions of additional public dollars on a dubiously rosy prospect of medical breakthroughs and cures, as they did in 2004. They would no doubt be delighted if they could also do-over the political argument that animated their first campaign, though to date Donald Trump has shown no interest in the issue. How voters will judge the promises, and how much weight they will give to non-monetary issues — built-in conflicts of interest, lack of oversight, outsourcing decisions about ethical standards, and the like — remains to be seen.”
The CIRM governing board has scheduled a Nov. 15 meeting to consider the proposed ballot measure. Changes in it can be made by its sponsor by the end of work Nov. 18. 
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