Wednesday, January 23, 2013

Reaction to IOM: California Stem Cell Directors Approve Plan on Conflicts of Interest and More

Directors of the $3 billion California stem cell agency today approved a far-reaching plan aimed at resolving long-standing conflict of interest issues involving the agency's governing board and also at helping to maintain credibility with the public.

Jonathan Thomas
CIRM photo
The framework of the proposal by CIRM Chairman J.T. Thomas moved forward on a 23-0 vote with one abstention. He laid out the plan in response to sweeping recommendations from a blue-ribbon study by the Institute of Medicine. Details will be worked out and come back to the board in March. 

Acknowledging that many board members were not pleased with the IOM criticism of the agency, Thomas said, 
“This is one of those times that we must move forward and compromise.” 
He said issues such conflicts of interest have “stolen focus” from the good scientific work that the agency has funded.

Thomas was reacting to the $700,000 IOM study commissioned by CIRM governing board. The IOM recommendations called for removing conflict of interest problems, cleaning up a troubling dual-executive arrangement and fundamentally changing the nature of the governing board. The IOM proposals would strip the board of its ability to approve individual grants, greatly strengthen the role of the agency's president, significantly alter the role of patient advocates on the governing board and engage the biotech industry more vigorously.

Thomas' plan, which would be put in place for up to a one-year trial period, would not do all that the IOM wanted, but would move strongly in that direction.

State Controller John Chiang, chairman of the only state entity with financial oversight over CIRM, endorsed most of the proposal, said deputy controller Ruth Holton-Hodson. She told CIRM directors that Thomas' plan was thoughtful and positive, although Chiang did not support continued involvement of the chairman in day-to-day operations.

The Thomas plan, which would not require legislative approval, would:
  • Have 13 members of the 29-member board refrain from voting on specific grant applications. The 13 would be from institutions that could benefit from CIRM grants. They would be allowed to participate in discussions. Thomas said this would deal with financial conflict of interest questions. 
  • Increase industry participation of industry in grant application review and step up business involvement internally at CIRM, including development of RFAs.
  • Redirect all scientific appeals to staff to evaluate for possible re-review before they go to the full board.
  • Move “programmatic” review of grants to public sessions of the full board instead of being held behind closed doors during grant review sessions. Patient advocate directors now sitting on the grant review group would no longer be allowed to vote during the closed-door review sessions, but they could participate in the discussion.
It appears, however, that the Thomas plan would do little to deal with the dual-executive problems identified by the IOM.

Consumer Watchdog's John M. Simpson, a long observer of the stem cell agency, welcomed the response by CIRM. Writing on his blog, Simpson said,
 "It looks like the message is finally getting through to California's stem cell agency board....
Part of what is driving the new approach is the realization that CIRM will need to find a new source of funding -- possibly going back to the voters -- if it is to continue.  As Thomas told the board today, 'If we don't have credibility, we won't have a chance of sustaining the agency.'"
During the lengthy debate this afternoon, one director after another said they did not agree with all that the IOM had to say, but said maintaining credibility and trust was the key to the sustainability of the organization.

CIRM will run out of money for new grants in less than four years. Thomas said he is working on a plan to continue the agency's effort into the future. Details of that will be disclosed later, he said.

(Editor's note: An earlier version of this item, based on incorrect information from CIRM, said the vote was 21-0. The correct figure is 23-0.)

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