Science in the Public Eye

1. Science in the Public Eye The Implications of the California Stem Cell Initiative for Science and Ethics April 20, 2005

2. Overview • What is Prop 71? • What does it create? • How Will This Science Funding Mechanism Work and How Long? • Immediate Operational Challenges • Immediate Policy Challenges • Immediate Opportunities • Long Range Challenges for Science and Ethics

3. Acknowledgements & Resources • Usual Media Resources • Days of Molecular Medicine, March 17-18 • Zach Hall • Irving Weissman • California Healthcare Institute (CHI) • Public Policy Institute of California (PPIC) • CIRM www.cirm.ca.gov • www.stemcellcommunity.org

4. What is Prop 71? • Failure of Federal Science Policy • Referendum – 400,000 signatures • “Democratization of Science” – CHI – or politization by special interests? • “Ingenious Funding Mechanism” – CHI • Strategy of the Constitutional Amendment • Implications of Support & Opposition

5. Robert Klein CHI – David Gollaher

6. “Ingenious Funding Mechanism” David Gollaher, CHI

7. Political Support/Opposition CHI – David Gollaher

8. Citizen Support/Opposition 50 counties – 22 voted NO Making Health Policy at the Ballot Box: Californians and the November 2004 Election, Public Policy Institute of California, February 2005 Mark Baldassare, Renatta DeFever, and Kristy Michaud

9. What Does Prop 71 Create? • California Institute for Regenerative Medicine (CIRM) • Independent Citizens Oversight Committee (ICOC)

10. California Institute for Regenerative Medicine (CIRM) • Newest NIH Institute • Location? – not in Bethesda -- no labs, no clinics • Goals • Safe, ethical, top quality science • NO human cloning • Benefit California Economy-Biotech • Authority • Leadership • Staffing • Grants Timetable

11. Independent Citizens Oversight Committee (ICOC) • Fiduciary and Policy Control • State Officials • Implications of Monthly Public Meetings • Relationship of Chair to CIRM President • Meet the Members • Working Groups

12. David Baltimore Robert Birgeneau Keith L. Black Susan V. Bryant Michael A. Friedman Michael Goldberg Brian E. Henderson Edward W. Holmes David A. Kessler Robert Klein Sherry Lansing Gerald S. Levey Ted W. Love, Richard A. Murphy Tina S. Nova Edward Penhoet Phillip A. Pizzo Claire Pomeroy Phyllis Preciado Francisco Prieto John C. Reed Joan Samuelson David Serrano Sewell Jeff Sheehy Jonathon Shestack Oswald Steward Leon J. Thal Gayle Wilson Janet S. Wright ICOC Members

13. Science and Advocacy CHI – David Gollaher

14. Scientific and Medical Accountability Standards – 19 5 ICOC Patient Advocacy Group Members Nine Nationally recognized clinicians or researchers involved in stem cell research Four Medical Ethicists Chair of the ICOC Scientific and Medical Funding – 23 7 ICOC Patient Advocacy Group Members Fifteen nationally recognized clinicians or researchers involved in stem cell research Chair of the ICOC Scientific and Medical Facilities – 11 6 members of the Scientific and Medical Funding Working Group Four real estate specialists Chair of the ICOC Citizen’s Financial Accountability Oversight – 5 Controller Treasurer President Pro Tem of the California Senate Speaker of the Assembly Chair of the ICOC CA Stem Cells Research & Cures Finance Committee – 6 Treasurer Controller Director of the State Department of Finance Chair of the ICOC Two ICOC members chosen by the Chair ICOC Working Groups Working groups submit recommendations to ICOC. The ICOC makes all final award decision – in public meetings.

15. Immediate Operational Challenges • January 05 • No Leadership • No Money • Bagley-Keene Open Meeting Act • Continuing Opposition • Judicial Challenges • Citizen’s Petitions – COI, Salary Caps • California Supreme Court

16. Immediate Public Controversies • Conflict of Interest • Intellectual Property and Access Issues • Protections for Women as Egg Donor “The initiative anticipated and the Institute is structured to provide significant conflict of interest regulations AND medical and ethical standards, especially those that protect women.” 3-16-05 Klein-Penhoet Statement

17. Immediate Opportunities • Richard Murphy: “This is an opportunity for public education about stem cell biology and human development. It is also an opportunity to articulate important ethical views different from those of the President’s Council on Bioethics.” March 17, 2005 DMM Mtg. • Scientific: Movement of best to California

18. California $295 Million/year for 10 years NIH in 2003 $25 M New Jersey $400 M New York $100M/$200M 2 yr. Wisconsin Connecticut Massachusetts Maryland -- no Washington – no EU $53M/yr 2002-2006 UK $187.3 M for public-private foundation Singapore $13 M/yr South Korea $22 M/yr over 10 years China – public support for R&D investment; “drive to clinic” Public Funding Comparisons NIH in 2005 = $28.3 Billion or $1.05 B per each of 27 institutes per year, after five year doubling effort; in 2000 = $14 Billion NCRR Clinical Center

19. Challenges for Science • Vacuum of Regulatory and Control Policy and Role of NAS • Creating and Managing Study Sections • Pressure for Open Study Sections • Quality and Control of Science • Balkanization of American Research • Pipeline of Stem Cell Biology Talent in CA • Impact of Media and Patient Advocates – role of public in research decisions -- Science should be published only after it has been replicated and shown to be robust. “Without these rules we would be heating ourselves today by cold fusion. “ • Hippocratic Oath for MD/PhD engaged in publicly funded biomedical research • Impact of basic science initial focus -- Stem Cells are not well differentiated, and intensity of media interest threatens reasonable interpretations of science. • Irving Weissman, DMM, March 17, 2005 • Substantial public research facilities outside federal control

20. Challenges for Ethics Mary Devereaux and Mike Kalichman