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C- for the California stem cell research program

Genetic Crossroads
January 27th, 2006

The Center for Genetics and Society's new report, The California Stem Cell Research Program at One Year: A Progress Report, was extensively covered in major California newspapers after its release last week. The 32-page study documents the numerous ways in which the California Institute for Regenerative Medicine (CIRM) has failed the public interest during its first year of operation. The report recommends major changes in the CIRM's policies, and calls for the chair of its governing board, Robert Klein, to step down. The overall grade it assigns to the institute for its first year is C-.

The combination of exaggerated promises, political polarization, and insufficient oversight makes this an especially critical time to put in place the regulations that are needed if research on stem cells and other emerging biotechnologies is to be pursued in a responsible and effective manner.

A sharply worded critique of the CIRM by the Los Angeles Times editorial board, which strongly endorsed Proposition 71, echoed the concerns raised by the Progress Report.

Media coverage of the CGS Progress Report

The Progress Report, authored by Jesse Reynolds and Marcy Darnovsky of CGS, calls for action in three broad areas. First, the CIRM should fulfill its campaign promises, such as ensuring financial returns to the state. Second, the CIRM should move quickly to establish accountable and responsible governance. Towards this end, Robert Klein should step down as chair of the CIRM's governing board. Finally, the CIRM should adopt enforceable ethical safeguards and research standards, such as those that will protect women who may provide eggs for the research.

The California stem cell program and the recent cloning scandals hold important lessons for legislators in other states and in Congress. A number of other states are considering their own stem cell research programs.

Who will benefit from publicly funded stem cell research?

Since the launch of the California stem cell program, CGS and other public interest groups have been pressuring the agency to ensure that the state of California will receive a share of profits generated by any successful CIRM-funded research, and that any treatments resulting from the research are broadly accessible.

CGS's Progress Report faults the agency's leadership for backtracking on campaign promises on those points, and recommends that the CIRM "develop and adopt intellectual property policies that ensure financial returns" and "ensure the affordability and accessibility of any successfully developed stem cell-based treatments." Another report, issued last week by the Foundation for Taxpayer and Consumer Rights, advocates intellectual property policies rooted in "affordability, accessibility, and accountability."

Now CIRM has proposed a plan for managing the ownership of inventions that addresses these areas.

This week, a task force of the CIRM's governing board recommended an intellectual property policy that would require a quarter of each grantee's share of revenues to be returned to the state. The policy also calls for a double track for ensuring the affordability of any treatments. The manufacturers of any product developed with CIRM-funded research would be required to offer it to state health programs, such as Medi-Cal, at the lowest available price. And the manufacturers would be required to develop and implement plans for offering the products to the state's uninsured population. The state could "march-in" and revoke a license if a manufacturer failed to follow through with its plan.

The plan still must be approved by the full governing board. It is on the agenda of its February 10 meeting in Palo Alto.

Reform plan likely to be reintroduced by California legislator

California Senator Deborah Ortiz (D-Sacramento) may reintroduce her legislation to reform the state stem cell research program. A supporter of the initiative that created the state program, she tabled part of her reform package last year after negotiations with the CIRM. Another part was vetoed by the Governor. In a recent speech, she outlined where she feels the CIRM still falls short, and said that she would devote her last year in office to strengthening these areas by reintroducing her proposals.

Related articles:

"Stem cell effort mired in legal bog, global scandal," San Francisco Chronicle (January 22)

Editorial: "Stem Cell Fallout," San Francisco Chronicle (January 20)

"Cash on hold, but stem cell work on," Oakland Tribune (January 17)

Opinion: "What California can learn from Korean cloning scandal," San Francisco Chronicle (December 13, 2005)  


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