California’s stem cell agency has for the first time laid out in some detail its view of the sweeping scope of its new charter -- approved by voters last fall and which directs the program into areas such as personalized medicine and therapy delivery over the next decade or so.
The agency’s perspective will be discussed in public Thursday morning before its 35-member governing board. The new path is charted in the form of 17 pages of slides plus annotations on a 17,000-word ballot initiative, which is more than twice as long as the U.S. Constitution.
The documents were posted online by CIRM yesterday afternoon, two and a half days before this week’s meeting....
You can read the full item here on the new platform for the California Stem Cell Report, the only independent, news and information source devoted solely to the Golden State's stem cell research program, the first of its kind in state history.
This blog's migration to a new platform is aimed at improving service to readers and helping to bring a new focus to our coverage, which began in January 2005 and which has carried in 5,000 items since then.
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Proposition 14, last fall’s ballot measure to save California’s stem cell agency from financial extinction, contains much, much more than the $5.5 billion it sought from the state’s voters.
Added to the agency’s charter is research involving mental health, “therapy delivery,” personalized medicine and “aging as a pathology.“ That is not to mention a greater emphasis on supporting “vital research opportunities” that are not stem cell-related.
The measure enlarged the board from 29 to 35 members — seats not yet filled as of this writing. But even at 29, the board has been much criticized for its large size, which creates more possibilities for conflicts of interest, a long-standing issue for the agency.
Proposition 14 bans royalties that are generated by state-backed stem cell inventions from being used for such things as prisons and schools, isolating the funds from tinkering by lawmakers....
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The California Stem Cell Report is the only independent, news and information source devoted solely to the Golden State's stem cell research program, the first of its kind in state history.
This blog's migration to a new platform is aimed at improving service to readers and helping to bring a new focus to our coverage, which began in January 2005 and which has carried in 5,000 items since then.
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Read all about it in an item posted today on a new platform for this blog, the California Stem Cell Report (CSCR), the only independent, news and information source devoted solely to the Golden State's 16-year-old research program, the first of its kind in state history.
This blog's migration to a new platform is aimed at improving service to readers and helping to bring a new focus to our coverage, which began in January 2005 and which has resulted in 5,000 items since then.
Directors of the $12 billion California stem cell agency will meet on Jan. 28 to examine the new and sweeping scope of their changing enterprise, now remodeled in a major way by voters as a result of the last fall's election.
Affordability, mental health and "aging as a pathology" are all part of the new charter for the California Institute for Regenerative Medicine(CIRM). Its governing board has scheduled a four-hour online session on the 28th that is open to public comment, questions and criticism.
Read about the meeting in an item posted this morning on a new platform for this blog, the California Stem Cell Report (CSCR), the only independent information source devoted solely to the Golden State's 16-year-old research program, the first of its kind in state history.
The blog's migration to a new platform is aimed at improving service to readers and helping to bring a new focus to our coverage, which began in January 2005 and which has resulted in 5,000 items since then.
The appointment of a new member to the governing board of California's $12 billion stem cell research program triggered additional comment and criticism today concerning conflicts of interest at the agency.
The matter involves Larry Goldstein, a well-known scientist at UC San Diego, who has received $22 million from the California Institute for Regenerative Medicine (CIRM), the formal name for the stem cell agency. Goldstein's employer has received $232 million.
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| Marcia Darnovsky CGS photo |
"Proposition 14, which just last fall gave CIRM another $5.5 billion of public funding, should have been a chance for the agency to turn over a new leaf, but it made none of the changes that could have addressed the agency's built-in conflicts or other structural problems.
"Now CIRM has accepted a board member who has personally received some $22 million in CIRM grants, and whose institution has received far more. It appears that CIRM will continue to flout basic principles of good governance, despite being a public agency wholly funded by public dollars. This is a real and ongoing problem."
Last September, Capitol Weekly, California's respected government and political news service, carried an analysis of CIRM awards and their relationship to board members. It showed that 80 percent of the $2.7 billion awarded by CIRM has gone to institutions with links to past and present members of the CIRM board.
The agency's 35 directors are barred from voting on specific awards to their institutions. However, they set the rules, scope and direction for the awards.
UC Davis stem cell scientist and blogger Paul Knoepfler, who supports the stem
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| Paul Knoepfler UCD photo |
"I'm sure that Larry will do an excellent job on the board, and he brings a unique depth of knowledge on stem cell research. However, along the lines of what Aaron said as quoted in the piece, at the very least the appointment presents some challenges of perception of the agency."
Knoepfler's reference is to Aaron Levine, a Georgia Tech biomedical research policy expert who served on the IOM panel that conducted a $700,000 study of CIRM and recommended major changes in its governance and conflict of interest procedures. Levine told the California Stem Cell Report,
“Larry Goldstein is, in many ways, an inspired choice for the CIRM board. He is a well-regarded stem cell scientist and former CIRM grantee with administrative experience and demonstrated interest in public policy. On the other hand, CIRM has, at the very least, a perception problem with conflicts-of-interest and appointing a former grantee to the board so soon after the passage of Proposition 14 seems to suggest that this challenge will persist.”
“More broadly, conflict of interest concerns reflect the structure of the CIRM Board dating back to Proposition 71 in 2004 and the broader challenge facing many organizations of recruiting interested, qualified, and independent board members. CIRM has taken a number of steps to help address conflicts of interest since the IOM report was published many years ago, but I would have liked to see the board structure adjusted as part of Proposition 14 to introduce more independence into the oversight structure and further address these concerns.”
CIRM was running out of money last year and was set to close its doors until voters approved Proposition 14, which provided $5.5 billion more and significantly expanded the scope of the agency.
CIRM had an opportunity to deal with conflict of interest concerns during the formulation of the ballot measure in discussions with the sponsor of the measure, Robert Klein, a millionaire developer in Palo Alto. Klein also directed the writing of Proposition 71 in 2004 and served as CIRM's first chairman after writing into the initiative qualifications for the chair that applied uniquely to him.
The California Stem Cell Report asked Klein this morning whether he had made a recommendation to any party that Goldstein, who is co-chair of a scientific advisory panel to Klein's stem cell advocacy group, be appointed to the CIRM board. Klein replied in an email this morning:
"No. I learned of the appointment after the fact. Dr. Goldstein will be an outstanding board member. Given that he has closed his lab at UC San Diego and he is no longer conducting stem cell research, his extraordinary research record on neurodegenerative diseases and his experience in previously competing for CIRM grants will provide the board with important insights in advancing the search for therapies that are devastating to the brain, the body’s neurological system, and many other disease areas."The State of California’s stem cell therapy development efforts and science generally will benefit greatly by Dr. Goldstein’s sacrifice of the remaining years he could have conducted scientific research, in favor of this new commitment to public service on the CIRM board, that will benefit patients everywhere."
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| Lawrence Goldstein in lab at Sanford Consortium, UCSD photo |
It is technically possible today to make changes in the law dealing with conflicts at CIRM and the composition of its board. However, those would require a super, super-majority vote (70 percent) of both houses of the legislature and the signature of the governor, a politically difficult task.
It was the first time in the history of the 16-year-old agency that a scientist who has received agency awards has been appointed to the board of the California Institute for Regenerative Medicine (CIRM), as the stem cell agency is officially known.
Goldstein's appointment raises once again questions involving conflicts of interest at the agency. Since its inception, CIRM has awarded $2.7 billion to California researchers and enterprises, including UC San Diego. Eight out of every ten dollars has gone to institutions with links to past or present CIRM board members, according to an analysis by the California Stem Cell Report.
Conflict of interest issues have dogged the agency since before voters created it in 2004. In a report in 2012 commissioned at a cost of $700,000 by CIRM itself, the prestigious Institute of Medicine (IOM) said,
“Far too many board members represent organizations that receive CIRM funding or benefit from that funding. These competing personal and professional interests compromise the perceived independence of (the CIRM governing board), introduce potential bias into the board’s decision making, and threaten to undermine confidence in the board.”
The IOM said the composition of the board, which is called the Independent Citizens Oversight Committee (ICOC) makes it neither “independent” nor capable of “oversight.”
In response to a question, Kevin McCormack, senior director of CIRM communications, said,
"Larry is no longer involved in any active CIRM awards and has stepped away from his research work, with the exception of one project for which he does not intend to seek CIRM funds.
"He brings a wealth of knowledge to the board and a different perspective as a leading stem cell scientist and former CIRM-funded researcher. As for conflicts, he is precluded from voting on any applications and cannot even participate in the discussion of applications submitted by UCSD."
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| Aaron Levine Georgia Tech photo |
“Larry Goldstein is, in many ways, an inspired choice for the CIRM Board. He is a well-regarded stem cell scientist and former CIRM grantee with administrative experience and demonstrated interest in public policy. On the other hand, CIRM has, at the very least, a perception problem with conflicts-of-interest and appointing a former grantee to the Board so soon after the passage of Proposition 14 seems to suggest that this challenge will persist.”
“More broadly, conflict of interest concerns reflect the structure of the CIRM Board dating back to Proposition 71 in 2004 and the broader challenge facing many organizations of recruiting interested, qualified, and independent board members. CIRM has taken a number of steps to help address conflicts of interest since the IOM report was published many years ago, but I would have liked to see the board structure adjusted as part of Proposition 14 to introduce more independence into the oversight structure and further address these concerns.”
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| Bob Klein California Stem Cell Report photo |
“I have known Larry for many years and have nothing but the highest regard for him as a scientist, a leader, and a great champion of stem cell research. He is also an innovative thinker and that will be invaluable to us as we move into a second chapter in the life of CIRM.”
Hundreds of California stem cell researchers this week took part in an online exploration of the new, $182 million research plans of the state's newly refinanced efforts to develop therapies for afflictions ranging from cancer to incontinence.
