Monday, January 21, 2013

'Insular and Somewhat Incestuous:' California Stem Cell Agency Grant Review Process

How can the Institute of Medicine's (IOM) conclusion about the grant review process at the $3 billion California stem cell agency be summarized? “Insular and somewhat incestuous” is the way one nationally known expert on medical ethics describes it.

The characterization was offered by Arthur Caplan, director of NYU Langone Medical Center’s Division of Medical Ethics, in a piece in the San Diego U-T, the dominant newspaper in that Southern California hotbed of biotech research.

In the article posted online late yesterday by reporter Bradley Fikes, Caplan said,
“Rather than getting into an ongoing debate about the adequacy of the existing peer review process, it should suffice to say that a distinguished, independent review found the current process to be insular and somewhat incestuous.” 
Fikes also reported,
"Michael Kalichman, director of the Center for Ethics in Science and Technology in San Diego, said the IOM report offers 'thoughtful' and constructive criticism. 
"'As funding becomes more limited, and this is likely, it will be necessary to make hard choices about what is and is not worth funding,' Kalichman said. 'Even if the decisions made are truly the best possible decisions, there is a high risk of the perception that particular voices represented on the ICOC (the agency's governing board) are heard better than those who are not represented.'”
Fikes' article is a preview of Wednesday's and Thursday's meetings in Berkeley during which the 29 directors of the agency are scheduled to discuss the IOM's $700,000 report, paid for by the agency itself, and determine a course of action.

Fikes' piece provided the first public IOM comment from Robert Klein, the former chairman of the stem cell agency. Klein directed the writing of the 10,000-word ballot initiative that created the stem cell agency eight years ago. He additionally crafted good portions of the measure including detailed qualifications for the chairman that appeared to restrict the choice to only one person in the state. Klein also lobbied his former colleagues vigorously and successfully last year for $40 million for StemCells, Inc., of Newark, Ca., 

Fikes reported that Klein  “said fears that grants would be awarded by favoritism have been disproved by experience. And patient advocates on the committee cooperate instead of compete, because research on one disease often proves useful for other diseases.”

One of the StemCells, Inc., applications was rejected twice by reviewers, whose actions were ultimately overridden by the board. Last year saw a record level of lobbying involving reviewer-rejected applications and patient advocates who sought to overturn decisions. At one meeting last fall, some board members expressed their displeasure with “arm-twisting,” lobbying and “emotionally charged presentations.” The board is also working on a new policy that would restrict “ex parte communications” – contact outside public board meetings – with board members.

The IOM additionally recommended that a majority of the agency's governing board consist of independent members. Currently the board has many conflicts of interest built in by Prop. 71, the measure that created the agency. About 90 percent of the $1.7 billion that the board has awarded as gone to institutions connected to persons who sit on the board, according to compilations by the California Stem Cell Report. Board members are barred from voting on applications from their institutions, but they set the agenda for what type of research is to be pursued and also approve detailed concepts of proposed requests for grant applications.

Fikes quoted UC Davis stem cell researcher Paul Knoepfler on the IOM recommendations for changes in composition of the board. Knoepfler said,
“Who exactly would be qualified to be on such a IOM-approved board and why should we Californians (and stem cell scientists and other stakeholders) trust them to be informed and passionate about stem cell research the way the current ICOC(the agency governing board) has shown itself to be over and over again? The IOM provides no answer to this question.”
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