Thursday, September 06, 2012

Arm-twisting and Emotion: Stem Cell Directors Move to Reform Appeals on Multimillon Dollar Grants

Frustrated with politicking, “arm-twisting,” lobbying and “emotionally charged presentations,” the governing board of the $3 billion California stem cell agency today approved short-term changes in its grant appeal process and ordered up a study to prepare long-term reforms.

The moves followed a prolonged series of appeals on grant applications that began in July and continued through today, setting records for the number of appeals and generating hours of sometimes tearful and emotion-laden presentations from members of the public.

The board adopted changes in the appeal process for its next few meetings that are aimed at curbing its free-wheeling nature and making it more understandable to the public and applicants. The board also directed creation of a panel to make recommendations by the end of the year for more wide-ranging reforms.

Directors of the agency were clearly not happy with the appeal process this summer. However, it has been a problem since 2008 when Bert Lubin, now a director of the stem cell agency and CEO of Childrens Hospital of Oakland, Ca., was the first applicant to make a public pitch before the board to overturn reviewer rejection of his application.

One director, UCLA medical school dean, Gerald Levey, said at the time,
"I don't think we can run a board this way. If we do, it would be chaos." 
Today, CIRM Director Carmen Puliafito, dean of the USC School of Medicine, said that “lots of lobbying” was going over the last couple of months. He predicted there will more lobbying and “more politicking.” Puliafito said,
“On big money grants, people will be calling their friends.”
The name of former board chairman, Robert Klein, was not mentioned during this afternoon's discussion. But Klein vigorously and successfully backed an appeal (see here, here and here) by StemCells, Inc., of Newark, Ca., for a $20 million application that had been rejected twice by reviewers. Last night the board approved the award on a 7-5 vote. It was the first time the board has approved an award that was rejected twice by its reviewers.

Director Jeff Sheehy, co-vice chairman of the review group and a communications manager at UC San Francisco, said the agency is dealing with “big money grants” that are “incredibly complex.” He also referred to “certain arm-twisting by certain individuals.”

Several board members made references to appearances by persons who have diseases or conditions that might be affected by CIRM-financed research. Director Duane Roth, head of CONNECT, a San Diego business development organization, said the board is making decisions in “an emotionally charged setting.”

Other issues cited by directors include the integrity of review process, fairness, consistency, shifting appeals procedures, transparency and board discipline on appeals.

James Harrison, outside counsel to the board, said the board's action today includes "eliminating the reference to unpublished data in the discussion of 'material new information," imposing a 3-page limit on other correspondence, explaining that applicants should have seven business days from the time the (grants review group) recommendation is made available to them to file an (extraordinary petition), and posting all of the information regarding these policies in one place on CIRM’s website."

For a list of articles and CIRM documents dealing with the appeal process, see here.

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