Monumental task of building state stem cell institute steadily inches forward
Members of the oversight committee for the stem cell institute at their meeting last month in Fresno.
BY MICHELLE L. BRANDT
Last November, when Californians approved the stem cell measure Proposition 71, few voters likely grasped the magnitude of the undertaking that was to be launched.
The pre-election chatter was largely about stem cell research's potential to treat devastating illnesses, not on the nuts and bolts of administering the institute that would fund such research. There was little public discussion about the challenges of setting up what could be the world's largest stem cell research foundation.
Only now, six months later, as the new California Institute for Regenerative Medicine is beginning to consider grant applications, are people becoming aware of the enormity of what state stem cell officials are poised to achieve.
"California put itself in a position to have to recreate in a fairly short period of time a funding apparatus and structure," said Dan Perry, president of the Coalition for the Advancement of Medical Research, a pro-stem-cell-research advocacy group in Washington, D.C. "These were things that the federal government took decades to develop and refine."
Members of the institute's oversight committee, including Philip Pizzo, MD, dean of the medical school, have had to build from scratch an agency that will award $3 billion in stem cell research grants over the next 10 years—a figure that dwarfs the current $25 million in federal support. They have encountered obstacles, most notably the legal challenges to the sale of the state bonds that raise the grant money and run-ins with state legislators who believe that the institute needs to be more accountable to the public.
Nonetheless, the group has made steady progress. Since the first oversight committee meeting in December, the group has named an interim president; launched an extensive search for a permanent leader, and selected San Francisco as its headquarters. It has adopted tough interim conflict-of-interest guidelines to ensure that its members' decisions are in no way perceived as tarnished by financial interests. At the same time, it has put in place ethical rules for researchers to guarantee that donors of eggs and embryos, which are needed to produce stem cells, are not exploited.
What's more, top scientists from other states have been recruited for a committee to award grants. Indeed, a call has been issued for applications—with a goal of distributing the first grants in the fall.
"Given the many challenges it faces, I believe that the institute and the Independent Citizens Oversight Committee (ICOC) have made remarkable progress in moving this process forward," Pizzo recently said.
Critics raise objections
Uphill battles are nothing new to Pizzo and his fellow ICOC members. From the beginning, the institute faced huge challenges—starting with the tasks of selecting scientists to review grant applications and developing protocols and ethical standards to govern the studies.
The committee also had to balance its desire to move quickly with the need to deliberate. During the board's first meeting, ICOC chair Robert Klein said the institute hoped to issue grants as early as May, and this drew fire from critics. "They can't just give out grants in six months—there is a lot of foundation to be laid," said Jesse Reynolds of the Oakland-based Center for Genetics and Society, which supports stem cell research but opposed Prop. 71. "If they go too fast they run the risk of stumbling and even failing."
The criticism faded when Klein acknowledged that the May deadline was too ambitious, but the committee faced numerous other complaints. Several groups have criticized the ICOC for its alleged failure to adhere to open meeting rules; its decision not to implement even more stringent conflicts-of-interest policies for themselves and institute staff, and the details in its safeguards to protect women who donate their eggs for research.
Problems in Sacramento
Even state Sen. Deborah Ortiz (D-Sacramento), a backer of Prop. 71, recently turned on the institute and proposed a state constitutional amendment that would dramatically alter the way it does business. Among other things, her measure would set even tougher conflict-of-interest provisions and require almost all institute meetings to be public—even ones where grants are reviewed under a peer-review process.
During the May 23 ICOC meeting, committee members called the proposed amendment "crippling" and "counterproductive." Guest speaker Paul Berg, PhD, the Robert W. and Vivian K. Cahill Professor of Cancer Research, Emeritus, said that a closed-door peer review process is critical; without it, he said, reviewers will be "mute" and "circumvent," and lesser research will ultimately be funded.
There are signs that Ortiz is ready to soften the language in her bill, but she isn't the only one posing a challenge. Several groups, including an anti-abortion organization, recently filed a lawsuit arguing that state government officials don't properly oversee the institute's finances. Due to this challenge, the state is unable to sell bonds to raise the $3 billion authorized by Prop. 71; the ICOC is now considering alternative ways to find money, such as borrowing from non-profit organizations.
"We are poised to move forward and we're being weighed down by regulations and challenges that aren't necessary," said Zach Hall, PhD, interim president of the institute. "Frankly I'm discouraged."
The nation is watching
Despite these hurdles, the ICOC has persevered. A small group of ICOC members, including Pizzo, recently began interviewing candidates for the institute's president. And last month it selected scientists and ethicists to serve on two working groups—one to review grant proposals, the other to finalize ethical standards and conflict-of-interest guidelines.
The institute may have also spawned pro-stem cell research activity in other states. Fearing the loss of scientific talent to California, leaders in more than two dozen states have introduced legislation to encourage stem cell research.
Irving Weissman, MD, director of the Stanford Institute for Cancer/Stem Cell Biology and Medicine, said that other states view the institute "with great envy." And Perry agreed that the institute—despite the bumps—has a lot to be proud of.
"I think they're doing it about right," Perry said of the ICOC and institute staff. "They're doing this all under intense scrutiny—from parties both friendly and unfriendly—and they're following complex rules that govern everything from meetings to members of grant committees.
"They're threading the needle quite skillfully."
