Science Is Not Enough

Lessons from the California Stem Cell Initiative

Just because California’s Proposition 71 passed in 2004 with 59 percent of voters favoring state-funded stem cell research does not mean that the science is poised to take off. In his talk at the sixth annual Seidman lecture at HMS, Zach Hall, president of the California Institute for Regenerative Medicine, the governing unit of the stem cell program, said the initiative is also navigating major political and cultural issues that go hand-in-hand with the science.

Photo by Liza Green, HMS Media Services

At the Seidman lecture, Zach Hall, who leads the California stem cell research program, emphasized the need for major political and cultural efforts to move the science along. Hall appears above with Barbara McNeil (left) and Nancy Andrews.

“Stem cell research offers the possibility of replacement cell therapy for type 1 diabetes, for neurodegenerative disease, for heart disease, for a variety of diseases,” Hall said. “And it is this broad scale of possibilities and the idea of its broad application that has been so exciting.” Though these potential therapies are many years away, stem cell research offers more immediate prospects of technological advances such as human cellular models for studying disease pathology, identifying drug targets, and screening for therapeutic compounds.

Despite the excitement, Hall said, there are serious ethical concerns. The most complicated involve beliefs about the nature of embryonic stem cells and the connection between reproductive and therapeutic cloning.

The law established by Proposition 71, the California Stem Cell Research and Cures Act, which authorizes $295 million a year for 10 years to fund stem cell work in the state, explicitly forbids reproductive cloning, the duplication of whole human beings.

The act also creates the Independent Citizens’ Oversight Committee (ICOC), which helps establish a broad network of stakeholders. Its 29 members include 10 patient advocates, four private-sector representatives, and 15 representatives of research institutions. And the bill provides for the California Institute for Regenerative Medicine (CIRM), of which Hall is president, that is responsible for administering grants. CIRM, to have 50 employees when full, is aided by three working groups, one for standards and ethics; one for facilities; and one for grants review, which is chaired by Stuart Orkin, a Howard Hughes investigator and the David G. Nathan professor of pediatrics at HMS and Children’s Hospital Boston.

These core components work with dozens of patient advocacy and other organizations, an arrangement that has posed both political and cultural challenges in determining how best to make progress.

What has the initiative accomplished so far? CIRM has organized its working groups, adopted administrative procedures, drafted medical and ethical standards, and established an intellectual property policy for nonprofit institutions that goes beyond the watershed Bayh–Dole Act.

Yet CIRM has not funded any grants. “The reason is that we are under litigation,” Hall said. “Last May, several of the organizations that oppose Proposition 71 filed suit against us on the grounds that we were giving away the state’s money but we weren’t really a state agency. And the net effect of that has been that we are unable to issue bonds as long as there is a possibility that we will be declared legally unconstitutional and out of business.” He said that CIRM does not expect to be out of litigation for another 12 to 15 months. The organization is now making progress in raising more than $50 million in bridge funds for grants and scientific programs.

“Success for stem cell research in California, and I would argue by extension in the United States, is more than a scientific matter,” Hall said. “It really requires imagination and vision and the political will to make things happen, and it requires the support of the public.”

Hall was introduced by Barbara McNeil, chair of the Department of Health Care Policy, which hosts the Seidman lecture each year.

—Robert Neal

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