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California Stem Cell Research Program (4)

Country: 
USA
Partner Institute: 
Institute for Global Health (IGH), University of California Berkeley/San Francisco
Survey no: 
(7)2006
Author(s): 
Anke Therese Schulz (UCSF) and Carol Medlin (Institute for Global Health, UC Berkeley and UCSF)
Health Policy Issues: 
New Technology, Pharmaceutical Policy, Funding / Pooling, Others
Reform formerly reported in: 
California Stem Cell Research Program
California Stem Cell Research Program (3)
California Stem Cell Research Program (2)
Current Process Stages
Idea Pilot Policy Paper Legislation Implementation Evaluation Change
Implemented in this survey? no no no no yes no no
Featured in half-yearly report: Health Policy Developments 7/8

Abstract

Since the previous reporting period, a lawsuit has temporarily halted implementation of the California Stem Cells Research Program. Despite this legal challenge, the California Institute for Regenerative Medicine (CIRM) has successfully obtained private funding and allocated it to stem cell researchers. Hearings for the court trial concluded on March 15, 2006. The judge is expected to announce a decision in the next few months.

Recent developments

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Characteristics of this policy

Degree of Innovation traditional innovative innovative
Degree of Controversy consensual highly controversial highly controversial
Structural or Systemic Impact marginal rather fundamental fundamental
current current   previous previous

The ratings have not changed since the previous survey.

Purpose and process analysis

Current Process Stages

Idea Pilot Policy Paper Legislation Implementation Evaluation Change
Implemented in this survey? no no no no yes no no

Initiators of idea/main actors

  • Government: The state government maintained its supportive position.
  • Civil Society: The Independent Citizen?s Oversight Committee (ICOC) maintained its strong support for the stem cells research program, while anti-abortion and pro-life groups continued to strongly oppose the measure. Public interest groups continued to support stem cell research, but some advocates strongly criticized the CIRM?s performance.
  • Scientific Community: The scientific community maintained its strong support for Proposition 71, but more researchers and bioethicists began to call for increased oversight. In addition, the scientific community was scandalized by a well-known South Korean researcher who falsified stem cell research results.
  • Others: During this study period, the courts became the most significant actor involved in the implementation of Proposition 71.

Stakeholder positions

Government

State legislature: Since the last reporting period, there has been no change in the state legislature's position toward Proposition 71.

Civil Society

The Independent Citizens' Oversight Committee (ICOC):  The ICOC maintained its strong support for the stem cells program, and ist oppositional stance toward government regulation (please see previous surveys for further details on the the ICOC).  In this study period, the ICOC has continued to raise private funds for stem cell research.  CIRM Chairman, Robert Klein, also directed much of his attention toward the court trial, presenting evidence and testimony to support stem cell research and Proposition 71.

Anti-abortion/pro-life groups: Lawsuits filed during the previous study period by anti-abortion groups are still pending.  These groups have not changed their position toward Proposition 71.

Public interest groups:  Public interest groups (e.g., Common Cause of California, the California Public Interest Research Group, Californians Aware and the California Tax Reform Association.) continued their support of stem cell research.  One group, on the other hand, expressed strong dissatisfaction with the CIRM and Robert Klein during this study period.  In January, a biotechnology advocacy group based in Oakland, the Center for Genetics and Society, released a progress report on the CIRM, and awarded  it a grade of C- for the way it has implemented Proposition 71. Robert Klein was faulted for "overly hyping" the promise of an early-stage science, for confusing voters as to some of the technical and financial details of Prop. 71, and for overestimating the likelihood that stem cell research will produce financial returns anytime soon. 

Separately, John Simpson, stem cell project director at another advocacy group, the Foundation for Taxpayer and Consumer Rights, said it would be a mistake to focus too much attention on Klein's leadership.  To newspaper reporters, Simpson said "I certainly understand the public outrage that led to the call for Bob Klein to step down, but the stem cell institute's problems go beyond personalities. We'll just have a revolving door of Bob Kleins until the structure is fixed." Simpson's group released recommendations on intellectual property rules, proposing that companies that go to market with their Prop. 71-financed research return a portion of their profits to the state. The state would then use that money to subsidize stem cell treatments to lower-income Californians.

Both advocacy groups maintained that the stem cell effort needs to operate more as a typical state agency, by expanding public oversight and adopting stricter policies against conflicts of interest.

Scientific community

Researchers: During this study period, despite legal challenges to Propostion 71, scientists continued their stem cell research efforts at a rapid pace. According to Dr. Arnold Kriegstein, Director of UCSF's Institute for Stem Cell and Tissue Biology, "..within universities throughout the state, scientists representing a broad array of disciplines have joined forces to move the science forward. They are developing strategic plans, organizing programs and recruiting pre-eminent scientists to their faculties. They are exploring partnerships with other universities, biotech companies and pharmaceutical companies, and are investing in lab space and equipment." Kriegstein argues that, the potential of stem cell research to reveal fundamental processes of human development and provide treatments for incurable diseases is simply too great to ignore or defer. He states that Prop. 71 funding would be a tremendous boon, providing a fertile environment for carrying out this research. Even without that money, however, stem cell scientists are pressing on.

The scientific stem cell community also suffered a highly-publicized scandal.  In January, an academic panel investigating embattled scientist Hwang Woo Suk concluded that the claims he and his research team made in 2004 about creating the world's first stem cells from a cloned human embryo were fraudulent, discrediting what appeared to be one of the biggest scientific breakthroughs of the decade. The dramatic claim that Hwang's team had cloned a human embryo and extracted stem cells from it was published in a landmark paper in the journal Science, heralding the stunning prospect of human cloning and the promise of using stem cell therapy to treat incurable diseases. But the findings of a monthlong investigation into Hwang's results by an eight-member peer review panel at Seoul National University, where most of the research was conducted, indicated that DNA studies on the two preserved stem cells did not match those from the published study and were not cloned human embryonic stem cells.

The panel's conclusions meant that the promising field of stem cell research is years behind where scientists thought it was. Medical researchers in the United States, reacting to what they described as one of the most significant scientific frauds in history, said they would now resume their own attempts to produce stem cells from cloned embryos -- widely considered a key to making stem cells more medically useful.

The legal community

The courts: Attorneys for taxpayer organizations and a conservative bioethics group urged Alameda County Superior Court Judge Bonnie Sabraw to invalidate sections of the 2004 initiative Proposition 71, claiming the initiative would allow billions of dollars in state bond money to be spent by an independent committee saddled with conflicts of interest and free from meaningful state control.  Judge Bonnie Sabraw took the case under submission on March 15, 2006.  She has not yet announced a decision.

Actors and positions

Description of actors and their positions
Government
State legislaturevery supportivesupportive strongly opposed
Civil Society
Independent Citizens' Oversight Comittee (ICOC)very supportivevery supportive strongly opposed
Anti-abortion/Pro-life groupsvery supportivestrongly opposed strongly opposed
Public interest groupsvery supportivesupportive strongly opposed
Scientific Community
Researchersvery supportivevery supportive strongly opposed
Bioethicistsvery supportivesupportive strongly opposed
The legal community
Alameda County Superior Courtvery supportiveneutral strongly opposed
current current   previous previous

Influences in policy making and legislation

The terms of Proposition 71 have not changed since the last reporting period.

Actors and influence

Description of actors and their influence

Government
State legislaturevery strongneutral none
Civil Society
Independent Citizens' Oversight Comittee (ICOC)very strongvery strong none
Anti-abortion/Pro-life groupsvery strongstrong none
Public interest groupsvery strongstrong none
Scientific Community
Researchersvery strongvery strong none
Bioethicistsvery strongstrong none
The legal community
Alameda County Superior Courtvery strongvery strong none
current current   previous previous
Independent Citizens' Oversight Comittee (ICOC), ResearchersState legislaturePublic interest groups, BioethicistsAlameda County Superior CourtAnti-abortion/Pro-life groups

Positions and Influences at a glance

Graphical actors vs. influence map representing the above actors vs. influences table.

Adoption and implementation

The CIRM , the ICOC, the scientific community, and one court are the primary actors currently involved in the implementation of Proposition 71.  Given that the implementation has been put on hold for months, it appears that pro-life activists have succeeded in at least temporarily blocking the implementation of Proposition 71.  On the other hand, the legal challenges have also galvanized stem cell researchers, who have developed creative ways to finance and conduct their work, even without state funding.

Monitoring and evaluation

Guidelines for monitoring the implementation of Prop 71 are now being drafted and negotiated among stakeholders. Monitoring and evaluation studies have yet to be conducted, pending the outcome of the court trial.

Expected outcome

The primary goal of Proposition 71 is to support stem cell researchers who are working on new treatments for debilitating human illnesses, such as paralysis and Alzheimer's disease.  This initiative has yet to be fully implemented. Stem cell research is also an emerging biotechnology with an unclear future at this stage of development.

Impact of this policy

Cost Efficiency very low neutral very high
current current   previous previous

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References

Sources of Information

Reform formerly reported in

California Stem Cell Research Program
Process Stages: Legislation, Idea
California Stem Cell Research Program (3)
Process Stages: Implementation
California Stem Cell Research Program (2)
Process Stages: Implementation

Author/s and/or contributors to this survey

Anke Therese Schulz (UCSF) and Carol Medlin (Institute for Global Health, UC Berkeley and UCSF)

Suggested citation for this online article

Anke Therese Schulz (UCSF) and Carol Medlin (Institute for Global Health, UC Berkeley and UCSF). "California Stem Cell Research Program (4)". Health Policy Monitor, 31/3/06. Available at http://www.hpm.org/survey/us/d7/1