Monday, June 29, 2009

CIRM Director Responds to Hoover Commission Recommendations

Jeff Sheehy, who has served on the board of the California stem cell agency since its inception and as acting vice chair of its grant review group, prepared the following piece on the Little Hoover Commission's report on the agency. Sheehy is a communications manager at UC San Francisco and is a nationally known HIV/AIDs patient advocate. Here is Sheehy's article.

Last Thursday, the Little Hoover Commission issued a report, "Stem Cell Research: Strengthening Governance to Further the Voters’ Mandate," recommending changes to Proposition 71, the initiative establishing the state’s stem cell research funding agency, the California Institute of Regenerative Medicine (CIRM).

CIRM has already mounted a vigorous negative response, which I, as a member of CIRM’s governing board (the Independent Citizens’ Oversight Committee or ICOC), find disappointing.

So while my preferred method of responding would have been through processes of the ICOC, that avenue has not been made available. Therefore, I am taking this opportunity to express my views.

To begin, I should flesh out the three underlying principles implicit in the report. First, CIRM is a tremendous success. While it will take time for the cures to emerge, incredible, innovative science in the new field of regenerative medicine has been funded, a dozen state-of-the-art research facilities are being built around the state, scores of scientists have been recruited to California from around the world, and networks have formed around the state that are the seeds for new Silicon Valleys, but of biotech not chips. Having established itself as the world’s hub for regenerative medicine, California is already reaping the benefit from the initial investments.

Second, Robert Klein has earned the gratitude of California for his incredible leadership in passing Proposition 71 and in leading the establishment of CIRM. His unimaginable level of effort has been the single biggest ingredient in CIRM’s success. If it were up to me, I would honor his service by naming CIRM after him upon his retirement.

Third, given CIRM’s success and Mr. Klein’s announced retirement upon completion of his term, we need to institutionalize CIRM as we plan for a longer future, sustained either by the proceeds of its loan program, additional voter approved funds, or appropriations from the Legislature. By the time the initial tranche of funding is exhausted, CIRM will have moved several potential therapies far down the developmental pipeline, and the economic stimulus from placing California ahead of the world in regenerative medicine will be obvious to everyone. Eventually there will be cures for chronic and life-threatening diseases that will save healthcare dollars. California will reap the economic benefit of being the home of many of the companies that provide those cures.

The Little Hoover Commission offers some reasonable suggestions for improvements that could help the functioning of CIRM and further institutionalize the agency. The 29-member ICOC is too big and too cumbersome—that’s obvious to anyone who regularly attends our meetings and sees us struggle to attain a quorum. The report seems to suggest an organic transition to a smaller board as terms end in 2010 and 2012.

Twelve members’ terms expire in 2010—4 from non-UC research institutions, 4 from non-UC universities, and 4 from the life sciences industry. I would recommend halving that number in proportion, which would reduce the ICOC by 6. The chair and vice-chair terms also expire in 2010 and the Little Hoover commission recommends not reappointing someone to those positions. Rather, they recommend that the chair and vice-chair be nominated from the membership of the ICOC and then voted in by the members. Two-year rotating terms are recommended. This would reduce the size by 2.

In 2012, the 5 UC medical school appointments expire along with the 10 patient advocate terms. I would alter the Little Hoover recommendations by reducing the UC medical school number to 3 and the patient advocate slots to 6 seats with 6 designated alternates. My rationales are that UC is part of the state of California and should be well represented, and that patient advocates currently fill 12 slots since the chair and vice-chair must have patient advocate credentials, so 6 would be the appropriate proportional reduction. Creating 6 alternates addresses persistent complaints of patient advocates that they are not allowed to appoint proxies. In addition, the participation of patient advocates in the working groups has been an extremely positive innovation in Prop. 71 and the alternates would be available for the working groups.

This would give the ICOC, hopefully renamed the Board of Directors for CIRM, 15 members. I would set a quorum of 9, which should be more easily attainable, especially with proxies and alternates. If prospective members cannot commit to adequate attendance, they should decline appointment, and non-attendance should be grounds for removal. I would strongly urge maintaining the original diversity, which has been strength, not a hindrance.

In addition, I would define the pool of conditions and diseases from which the patient advocates are drawn more broadly and not specify which conditions or diseases an individual advocate must be drawn from, but merely state that each patient advocate must be drawn from a different disease or condition. Further, I would recommend that either the chair or vice-chair should be a patient advocate member. And to address the inequitable and immense economic burden of service for lower income ICOC members, I would increase the per diem by a reasonable multiple.

Little Hoover recommends 4-year terms. Again, this makes sense. The transition should occur organically as proposed above and that would give staggered terms so the entire Board does not turn over at once. I think the non-UC appointment process should be considered carefully. It should reflect a balance of power between Legislature and the Governor and/or other constitutional officers such that individuals are appointed for merit and desire to serve CIRM’s mission and not to fulfill any political agenda.

In eliminating the appointed chair and vice-chair, I agree with the Little Hoover commission on eliminating the operational aspects of those positions. The new Board should be focused exclusively on oversight and not day-to-day management, which belongs in the hands of a president hired by and accountable to the Board. This is not intended nor should it be construed as any criticism of Mr. Klein. I believe that if a successful restructuring is accomplished, his dual role will be properly perceived as a heroic sacrifice for CIRM’s mission and an essential feature of its success in initiating its operations. If we try to fill Mr. Klein’s shoes, I believe we risk the success of the entire enterprise.

The Little Hoover ccommission recommends expanding the size of the agency beyond 50 employees. I do not know anyone who does not think this is reasonable. I would suggest a cap, but that number should be determined after thorough analysis.

I also think most agree that the 15-member limit for scientist grant reviewers is too low. This should be expanded, again after thorough analysis. In addition, the current staff-led triage process should be eliminated in favor of a process within the structure of an expanded Grants Working Group. I must reject other changes to the peer review process. The operation of the Grants Working Group has been an outstanding success, and CIRM staff should be commended.

Finally, I heartily support a performance audit by the Citizens’ Financial Accountability Oversight Committee, an entity established by Prop. 71.

In short, I wish the report by the Little Hoover Commission could be perceived and advanced as the beginning of a dialogue about governance structures that results in the strengthening and institutionalization of CIRM and sets it on a path towards a long and fruitful existence.

2 comments:

  1. At any rate, I liked some of the vadlo biology cartoons!

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  2. Anonymous11:20 PM

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