Wednesday, October 24, 2012

Texas Science Flap Cited as California Stem Cell Agency Eyes its Own Processes

OAKLAND, Ca. – Meeting against a backdrop from Texas that involves conflicts of interest and mass resignations of grant reviewers, a task force of the $3 billion California stem cell agency today began a partial examination of its own grant approval process, specifically focusing on appeals by rejected applicants.

The president of the California organization, Alan Trounson, told the task force that it was dealing with a “very serious matter” that in some ways is similar to what happened in Texas. He said the science community is “very much concerned.”

The situation in Texas involves the five-year-old Cancer Prevention and Research Institute, which like the California stem cell agency, formally known as the California Institute of Regenerative Medicine (CIRM), has $3 billion of borrowed money to use to finance research.

The chief scientific officer of the Texas organization, Nobel laureate Alfred Gilman, resigned Oct. 12 during a flap about its attempts “to simultaneously support basic research and nurture companies.”
Gilman's departure was triggered by a $20 million award made without scientific review. Reviewer resignations followed with letters that accused the Texas group of “hucksterism” and dishonoring the peer review process. (Writer Monya Baker has a good overview today in Nature.)

The situation in Texas came to a head AFTER the governing board of the California research group created its task force. The problems in Texas are bigger and not identical to those in California, which mainly involve the free-wheeling nature of the appeal process, not an entire lack of scientific review. Nonetheless, this past summer, directors of the California agency for the first time approved an award that was rejected twice by reviewers. The award went to StemCells, Inc., of Newark, Ca., which now has won $40 million, ranking the company No. 1 in awards to business from CIRM.

Earlier this month, Los Angeles Times business columnist Michael Hiltzik characterized the StemCells, Inc., award as “redolent of cronyism.”

Today's session of the CIRM task force focused primarily on an aspect of the agency's appeals process that CIRM labels as “extraordinary petitions.” They are letters which rejected applicants use to challenge decisions by grant reviewers. The researchers follow up with public appearances before the governing board, often trailing squads of patients making emotional appeals.

Both researchers and patients have a right under state law to appear before the CIRM board to discuss any matter. CIRM, however, is trying to come up with changes in the appeal process that will make it clear to researchers on what the grounds the board might overturn reviewers' decisions. The agency is also defining those grounds narrowly and aiming at eliminating appeals based on differences in scientific opinion.

At today's meeting, CIRM Director Jeff Sheehy, a patient advocate and co-vice chair of the grants review group, said peer review is an “extraordinary way of analyzing science, but it is not always perfect.” However, he also said that “as a board we are not respecting input” from scientists and thus allow the perception that we can be “persuaded against the judgment of scientists.”

CIRM Director Oswald Steward, director of the Reeve-Irvine Research Center at UC Irvine, agreed with a suggestion by Sheehy that board must act with “discipline” when faced with appeals by rejected applicants. Steward said, 
“The process has gotten a little out of hand.”
It was a sentiment that drew no dissent at today's 90-minute meeting.

Missing from today's meeting, which had teleconference locations in San Francisco, Irvine, La Jolla and Palo Alto, were any of the hundreds of California scientists whose livelihoods are likely to be affected by changes in the grant approval process. Also absent were California biotech businesses, along with the only representative on the task force from CIRM's scientific reviewers.

Our comment? When researchers and businesses that have millions at stake fail to show up for key sessions that set the terms on how they can get the money, it is a sad commentary on their professional and business acumen.

Bert Lubin, a CIRM director and chairman of the task force, indicated he would like to have two more meetings of the task force prior to making recommendations to a full board workshop in January with possible final action later that month. Lubin, CEO of Children's Hospital in Oakland, said the matter is “really important for the credibility of our whole organization.”

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