Science in the Public Eye

The Implications of the California Stem Cell Initiative for Science and Ethics

April 20, 2005

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

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

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

Robert Klein

CHI – David Gollaher

“Ingenious Funding Mechanism”

David Gollaher, CHI

Political Support/Opposition

CHI – David Gollaher

Citizen Support/Opposition

Making Health Policy at the Ballot Box: Californians and the November 2004 Election, Public Policy Institute of California, February 2005Mark Baldassare, Renatta DeFever, and Kristy Michaud

50 counties – 22 voted NO

What Does Prop 71 Create?

• California Institute for Regenerative Medicine (CIRM)

• Independent Citizens Oversight Committee (ICOC)

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

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

ICOC Members• 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 PenhoetPhillip A. PizzoClaire PomeroyPhyllis PreciadoFrancisco PrietoJohn C. ReedJoan SamuelsonDavid Serrano SewellJeff SheehyJonathon ShestackOswald StewardLeon J. ThalGayle WilsonJanet S. Wright

Science and Advocacy

CHI – David Gollaher

ICOC Working Groups• 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

Working groups submit recommendations to ICOC. The ICOC makes all final award decision – in public meetings.

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

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

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

Public Funding Comparisons

• 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”

NIH in 2005 = $28.3 Billion or $1.05 B per each of 27 institutes per year, afterfive year doubling effort; in 2000 = $14 BillionNCRR Clinical Center

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

Challenges for Ethics

Mary Devereaux and Mike Kalichman