Proposed Changes To Oversight Panel For California's Stem Cell Agency Garner Backing

Supporters of California's $3 billion stem cell research program are endorsing proposed changes to remove conflicts of interest and build public trust.

While the agency has won praise for supporting research on cures for disease and injuries, criticism of the financial and personal conflicts appears to have hit home.

The changes were proposed last month by Jonathan Thomas, chairman of the California Institute for Regenerative Medicine.

Thomas suggested that oversight committee members representing academic or business institutions voluntarily abstain from voting on all grant proposals, even those that don't present a direct conflict. In addition, patient advocates on the committee would lose their votes on a subcommittee that recommends
grants, although they would retain voting rights on the full committee.

CIRM's governing oversight committee is scheduled to consider the changes at a meeting in March.

Critics say it's problematic that the great majority of grants go to institutions represented on the governing oversight committee. They say this smacks of self-dealing with taxpayer money. Defenders say these institutions were chosen to be on the board because they possess needed expertise.

In addition, critics say patient advocates, present on the board by law, could preferentially fund research on their favored diseases. Patient advocates have bridled at that suggestion, and passionately vowed to defend their role at CIRM.

But in the past few weeks, some of the strongest supporters of CIRM say they've concluded that stronger ethical guidelines may be the only way to preserve its mission.

One of those supporters, oversight committee member Jeff Sheehy, said he's reluctantly decided the changes are probably necessary to quell public concerns that the agency is favoring cronies.

"Dr. Thomas' efforts, I hope, will go a long way to addressing people's concerns," said Sheehy, who fills one of the committee's designated patient advocate positions.

Time is one factor behind the change of heart. CIRM was established in 2004 by California voters who approved Proposition 71. Its funds come from bonds sold by the state, and that money is shrinking.

The agency estimates it will grant the last of the $3 billion by 2017. Well before then, it has to decide on how to continue its mission. Supporters and critics alike say raising money, whether by going back to the taxpayers who started it, or through private philanthropy, will be difficult if conflicts or their appearance continues.

Committee member Michael Marletta, who heads The Scripps Research Institute, said the "Draconian" changes are unduly harsh and not warranted. Marletta, the lone abstention from a CIRM vote to put the changes on the March agenda, stopped short of saying he would vote against them.

Thomas issued his recommendations in response to a report given in December by the prestigious Institute of Medicine, outlining conflicts of interest in CIRM's governing oversight committee. The institute, a division of the National Academy of Sciences, wrote the $700,000 report at the request of CIRM.

"This is a way of directly addressing the central concern that the IOM had over the financial conflict question," Thomas said of the abstention proposal. While the abstentions will be voluntary, Thomas said he had no doubt that oversight committee members will comply if the recommendations are approved.

CIRM-funded scientists Jeanne Loring of The Scripps Research Institute and Paul Knoepfler of UC Davis said the changes are acceptable because they don't harm the agency's mission of speeding up development of disease and injury treatment from stem cells.

David Brenner, an oversight committee representative from UC San Diego School of Medicine, said the IOM's criticisms were fair.

"J.T.'s (Thomas) very careful, very thoughtful proposed changes keep the board intact as was intended by the state of California, but eliminates those two areas (institutional voting and patient advocate voting) where there were thought to be conflicts," Brenner said.

Brenner, UCSD's vice chancellor of health sciences and dean of its school of medicine, said it was important to remember that the IOM report also included great praise for CIRM's effectiveness in advancing stem cell research.

"From the San Diego point of view, it's been remarkably successful for us," Brenner said. "All the major institutions in San Diego have benefited tremendously. There're actually drugs that were pushed through, for
myleofibrosis for example, that were largely funded through the concept of cancer stem cells. And the Sanford Consortium for Regenerative Medicine is a spectacular collaborative laboratory, with multiple different institutions interacting."

The Sanford Consortium consists of UCSD, The Scripps Research Institute, the Salk Institute, the Sanford Burnham Medical Research Institute and the La Jolla Institute for Allergy & Immunology. Scientists from all five institutions work in a $127 million building; $43 million of that total came from CIRM.

John Simpson, a longtime CIRM critic, welcomed the proposed changes.

Thomas is more adept at meeting public concerns than his predecessor as chairman, Bob Klein, said Simpson. He is a representative of Consumer Watchdog, a nonprofit that has often criticized CIRM. Klein led the campaign to create CIRM with the passage of Proposition 71 in 2004.

"Under the former leadership, whenever there was criticism from outside, there was a tendency to circle the wagons," Simpson said.

While the recommendations represent a step forward, Thomas and the other board members are "driven by pragmatism," Simpson said.

"They understand that in a year or two, they're going to be out of funding, and they're going have to come back as a credible organization if they want to have any kind of sustainability," Simpson said.

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