Source: http://GAPComments@cirm.ca.gov/about-cirm/newsroom/press-releases/10122005/brief-amici-curiae-support-defendants%C3%A2%E2%82%AC%E2%84%A2-motion-judgment
Timestamp: 2013-05-19 21:28:28
Document Index: 106998616

Matched Legal Cases: ['§ 2', '§ 2', '§ 14165', '§ 44213', '§ 65911', '§ 12903']

Brief of Amici Curiae in Support of Defendantsâ€™ Motion for Judgment on the Pleadings O'MALLEY M. MILLER (State Bar No. 071963)
see also NIH Research Priorities, supra note 4 (“funding is usually determined by the scientific
merit of research applications”).7 See American Institute of Biological Sciences, Position Statement: Scientific Peer Review in
Policy Making, July 15, 2004 (“Scientific peer review should be insulated from politics as
much as possible. Oversight of scientific peer review should be vested in scientists and
science managers within the agencies. This adds assurance that the composition of panels is
not being unduly influenced by politics and constitutes a representative subset of the scientists
most competent to review and assess the topic. The agencies must be trusted to perform the
task of constituting and overseeing fair and independent scientific peer review efforts, without
interference from political entities”) (http://www.aibs.org/positionstatements/
040715_scientific_peer_.html).
small number of cell lines existing on that date.8 While some basic research can be accomplished with existing lines, nearly all scientists agree that new stem cell lines are essential to efficiently advance the scientific and therapeutic potential of regenerative medicine.9 The federal directive does not prevent non-federally funded development of new stem cell lines, and some non-profit organizations and corporations have pursued this research.10 But these sources of funding are insufficient without public funding, which the Institute of Medicine has called the “wellspring of medical breakthroughs.”11 Similarly, in 2002 and 2003, the United States House of Representatives passed a bill that would have criminalized somatic cell nuclear transfer, a critical aspect of stem cell research.12 While this bill never received consideration on the floor of the Senate, it nonetheless sent an intimidating message.13
A lack of stable, sufficient funds for research into embryonic stem cell therapies deters young researchers from choosing to pursue a career in this field,14 and prevents institutions from dedicating substantial facilities to the field.15 In addition, as the Institute of Medicine has stated:
8 See Fact Sheet, Embryonic Stem Cell Research, The White House (Aug. 9, 2001),
http://www.whitehouse.gov/news/releases/2001/08/20010809-1.html (describing President Bush’s
stem cell policy).9 Among other reasons, new cell lines are required because federally approved cell lines were
cultured in the presence of animal cells or serum, which may contain viruses and other infectious
agents not normally found in humans. In addition, stem cell lines tend to change over time,
becoming increasingly distant from native human tissues. See Committee on the Biological and
Biomedical Applications of Stem Cell Research, Institute of Medicine, Stem Cells and the Future
of Regenerative Medicine, 3, 33 (2002), http://www.nap.edu/books/0309076307/html [hereinafter
IOM Recommendation] (adding that “while there is much that can be learned using existing stem
cell lines if they are widely available for research, such concerns necessitate . . . the development
of new stem cell lines in the future”).10 For example, Geron Corp. claims to have derived the first human embryonic stem cell line
without direct exposure to animal-sourced products. See Press Release, Geron Corp., Geron
Provides Update on Human Embryonic Stem Cell Programs at International Society for Stem
Cell Research Annual Meeting (June 23, 2005), http://www.geron.com/press.asp.11 IOM Recommendations, supra note 9, at 3.12 H.R. 2505, 107th Cong. § 2 (2002); H.R. 534, 108th Cong. § 2 (2003).13 A similar bill is currently pending in the United States Senate. S. 658, 109th Cong. (2005).14 Insufficient funding in a “young field such as stem-cell research [makes it] difficult . . . to
gather enough preliminary data to make a case for serious study” and obtain grants. See Peter
Aldhous, News Feature: After the Gold Rush, 434 Nature 694, 696 (2005). CIRM plans to
provide “seed” money to attract new researchers to the field. Id.15 Federal dollars may not be used to support any research on stem cell lines created after August [P]ublic funding offers greater opportunities for regulatory
oversight and public scrutiny of stem cell research. Stem cell
research that is publicly funded and conducted under established
standards of open scientific exchange, peer review, and public
oversight offers the most efficient and responsible means of
fulfilling the promise of stem cells to meet the need for regenerative
medical therapies.16
C. Proposition 71
Proposition 71 was specifically designed to redress the restrictions on federal funding for human embryonic stem cell research. The Act authorizes expenditure of $300 million per year for 10 years for stem cell research, filling the gap in federal funding for what is, for millions of patients and their families, the most promising area of medical research of our time.17
The Act establishes a 29-member governing board, the ICOC, to make final decisions on how the research funds authorized by the Act should be spent. Twenty-seven of the ICOC’s members are appointed directly by state officials, including the Governor, Lieutenant Governor, Treasurer, Controller, the Speaker of the Assembly, the President pro tempore of the Senate, and the Chancellors of the five University of California campuses with medical schools. These 27 appointed members then pick a chair and vice-chair from lists of nominees provided by the Governor, Lieutenant Governor, Treasurer, and Controller. The ICOC’s members serve fixed six- or eight-year terms. 9, 2001, so researchers must ensure that projects funded by Proposition 71 are strictly separated
from projects involving federal grants. For example, the Stanford Institute for Cancer/Stem Cell
Biology has initially planned to separate California-funded stem cell research by requesting
grants to remodel or construct new facilities. See 5 Questions: Longaker on Stem Cell Research,
Stan. Rep., April 6, 2005, at 7, http://news-service.stanford.edu/news/2005/april6.16 IOM Recommendations, supra note 9, at 3; see also id. at 52–54 (adding that public funding
fosters stringent peer review); Saira Moini and Bill Kearney, Science & Society: The Promise
and Perplexities of Stem Cells, The National Academies InFocus, Fall/Winter 2001, at 26,
http://www.infocusmagazine.org/1.2/science_society.html (“Without government funding of basic
research on stem cells, progress toward medical therapies is likely to be hindered. Private
industry may be reluctant to fund research that could take many years and with no guarantee of
the results yielding profitable applications.”).17 See IOM Recommendation, supra note 9, at 34-36 (outlining evidence supporting potential use
of human embryonic stem cells in regenerative medicine); Fred H. Gage and Inder M. Verma,
Introduction: Stem Cells at the Dawn of the 21st Century, 100 Proc. of the Nat. Acad. Sci. 11817,
11817 (2003) (describing potential cures); Stem Cell Information, Frequently Asked Questions,
National Institutes of Health, http://stemcells.nih.gov/info/faqs.asp#whatare.
Proposition 71 requires that the ICOC’s membership include informed public and private individuals with a diverse range of backgrounds and viewpoints especially relevant to stem cell research. Five ICOC members are representatives of the University of California medical schools; four are representatives of private California universities with demonstrated leadership in stem cell research; four are representatives of California nonprofit academic or research institutions that have demonstrated leadership in stem cell research; four are representatives of California life science companies with experience in implementing successful medical therapies; and ten are advocates for people suffering from diseases and conditions believed likely to benefit from therapies and prevention strategies developed from stem cell research.
The practical wisdom of these provisions is manifest in the ICOC’s current membership, which includes individuals with long and distinguished careers in the relevant sciences and medical specialties. The ICOC includes several members of the distinguished National Academy of Sciences18 and Institute of Medicine,19 Nobel Prize winner David Baltimore, former U.S. Food and Drug Administration commissioner David Kessler, and Ed Penhoet, biochemist and cofounder of Chiron, the developer of therapies for diseases such as Hepatitis B. In addition, several prominent patient advocates serve on the ICOC, including, for example: Sherry Lansing, chair of Stop Cancer as well as the former chair of Paramount Pictures; Joan Samuelson, founder and president of the Parkinson’s Action Network; and Oswald Steward, Ph.D., chair and director of the Reeve-Irvine Research Center at the University of California, Irvine.20
Plaintiffs challenge Proposition 71’s constitutionality, inter alia, on the ground that the ICOC is “too independent.” Although the precise basis of this argument is unclear, plaintiffs
18 David Baltimore and Robert Birgeneau. See Members, National Academy of Sciences (2005),
http://www.nasonline.org (follow “Members” hyperlink).19 David Baltimore, Brian Henderson, Edward Holmes, David Kessler, Ed Penhoet, and Philip
Pizzo. See Membership, Institute of Medicine of the National Academies (June 6, 2005),
http://www.iom.edu/membership.asp (follow “2005 IOM Public Directory,” then download PDF
directory).20 See ICOC Members List, ICOC Info, California Institute for Regenerative Medicine,
http://www.cirm.ca.gov/icoc.
appear to contend that state officials do not exert “sufficient control” over the ICOC’s members to make the ICOC an entity “under the exclusive management and control of the State” pursuant to Article XVI, Section 3 of the California Constitution.
For several reasons, this argument is without merit. As the Attorney General points out in his moving papers, Proposition 71 itself amends the California Constitution by adding Article XXXV, Section 6. The amendment provides that, notwithstanding any other provision of the Constitution, CIRM (of which the ICOC is the governing body) is established in state government and may spend state funds. The voters thus made sure there was no constitutional impediment to CIRM spending state funds for regenerative medicine. Moreover, all of the ICOC’s members are appointed or nominated by state elected officials or state officials who hold public office, and the Act provides both adequate guidance on the manner in which taxpayer funds are to be spent and adequate external controls to ensure that the funds are spent within the limitations specified in the Act.
The details of issues relating to constitutional and statutory interpretation we leave to the Attorney General. Amici submit this brief to explain why the structure and composition of the ICOC will help ensure that the $3 billion in stem cell research funds authorized by Proposition 71 are expended in the manner the voters desired: to develop meaningful treatment, prevention strategies, and cures for serious diseases afflicting millions of people.
A. The Structure and Composition of the ICOC Ensure That Funding Decisions Will Be Made Based on Scientific Merit.
The ICOC’s structure and composition are carefully designed to produce the same benefits as the peer review process used by the NIH. To ensure that stem cell research funds are spent in a scientifically sensible manner consistent with Proposition 71’s mandate, the Act establishes a two-step process similar to that used at the NIH.
First, all proposals are subject to exacting peer review by working groups that include both nationally recognized scientists and representatives of advocacy groups.21 By virtue of their
21 Section 125290.60(b) (describing Scientific and Medical Research Funding Working Group’s background and experience, these individuals are particularly well equipped to evaluate significant issues: whether the proposal is original and innovative; whether the proposal is scientifically plausible and realistic; whether the proposal’s design is adequately developed; and whether the proposed investigators have the necessary facilities and expertise to conduct the proposed study.22
Second, recommendations by the working groups (including certain dissenting opinions) are then evaluated by the 29-member ICOC, which has final authority to decide which research proposals will be funded. As noted above, the ICOC itself is composed of individuals who are extraordinarily well qualified to make the scientific and health-policy judgments necessary to decide whether to accept or reject the recommendations made by the working groups. Decisions about which research proposals warrant funding are thus made by those with the knowledge and expertise necessary to make informed assessments of both the scientific merit of a proposal and the extent to which a proposal is likely to contribute to the search for meaningful prevention strategies, cures, and treatments.
Plaintiffs fault the ICOC because it “has no members who are elected or public officials.” (Complaint ¶ 12.) But the long history of public funding of medical research has demonstrated the wisdom of using peer reviewers and informed public participants rather than elected officials to assess the scientific merit of a given proposal. Rather than establishing a committee composed of the Governor, Lieutenant Governor, Treasurer, and Controller to make final funding decisions, Proposition 71 sensibly requires these elected officials to appoint to the ICOC members whose background and experience render them qualified to evaluate the scientific merits of competing research proposals.
Moreover, nothing in the California Constitution precludes the State from allocating scientific research funds through a process that insulates individual funding decisions from direct
role in peer review of grant applications and recommendation of awards to ICOC).22 NIH’s five review criteria provide an idea of how peer review generally operates. See NIH Has
Five Review Criteria, Grant Application Basics, National Institute of Allergy and Infectious
Diseases, http://www.niaid.nih.gov/ncn/grants/basics/basics_b3.htm.
political influence. By establishing a governing body whose members serve for fixed terms and cannot be removed at will by the officials who appoint them, Proposition 71 allows members of the ICOC to make assessments governed solely by their view of the objective merits of a particular proposal, without concern for political expedience. The Act thereby ensures that taxpayer funds will be allocated to those research proposals holding the most scientific and therapeutic promise, in a manner similar to the process utilized with great success at the NIH. In this respect, Proposition 71 is no different from an act establishing any other government agency dealing with scientific or other highly specialized matters.23
B. The ICOC’s Structure Helps Ensure Long Term Stability of Funding.
The ICOC’s structure also provides important stability in an area where research and development require a long term commitment. As noted above, the federal government has not been willing to provide that commitment in the area of embryonic stem cell research. Although congressional attempts are underway to relax some of the restrictions currently in place, the prospects for ultimate passage remain uncertain and a veto has been threatened as to any such legislation. Given the highly politicized nature of the subject, embryonic stem cell research remains especially vulnerable to shifts in political winds and the political fortunes of particular officials and candidates.
Further, while regenerative medicine is one of the most promising fronts of medicine today, research and development of practical medical treatments and cures will almost certainly take many years.24 Any uncertainty as to whether a reliable source of funding will exist in future years would make it extremely difficult to attract young and innovative researchers to careers in an otherwise promising new field.25 No one wants to start down a new path of research that 23 See, e.g., California Medical Assistance Commission (Welf. & Inst. Code § 14165.2), State
Commission on Teacher Credentialing (Ed. Code § 44213), Student Aid Commission (Ed. Code
§ 65911), and Fair Employment and Housing Commission (Govt. Code § 12903).24 See Ruth R. Faden and John D. Gearhart, Facts on Stem Cells, Washington Post, August 23,
2004, at A15; Moini and Kearney, supra note 15, at 26.25 See supra note 14.
shows great promise only to have funding for that research thrown into doubt every election cycle.
Proposition 71 addresses this problem first by providing a reliable source of long term funding, roughly $300 million annually over a period of 10 years, and second by providing fixed terms of office for ICOC members. Because the ICOC’s members serve for fixed six- or eightyear terms and are not subject to removal at the whim of the officials who appoint them, their funding decisions cannot be reversed by elected officials who do not agree with the goals of Proposition 71. Thus, researchers whose proposals are selected for funding can be assured that an elected official’s displeasure with a particular funding decision will not result in funding being revoked the following year.
C. The ICOC’s Composition Ensures That a Wide Range of Scientific Viewpoints and Informed Public Perspectives Will Be Represented.
Finally, by specifying criteria for the composition of the ICOC, Proposition 71 ensures that funding decisions will reflect input from a wide variety of scientific and disease advocacy viewpoints. The Act mandates that the ICOC include representatives of the five University of California campuses with medical schools, other leading private or public universities in California, non-profit academic and medical research institutions, and companies with expertise in developing medical therapies. In addition, the Act requires the ICOC to include representatives of organizations concerned with ten specified diseases likely to benefit from stem cell research: spinal cord injury; Alzheimer’s disease; type II diabetes; multiple sclerosis or amyotrophic lateral sclerosis; type I diabetes; heart disease; cancer; Parkinson’s disease; HIV/AIDS; and mental health problems.26 This diverse range of viewpoints and backgrounds ensures that funding decisions will not be dominated by any one narrow perspective and that knowledge will not be pursued solely for the sake of knowledge.
The presence of the disease advocacy representatives has the additional benefit of enhancing the role that non-scientists play in making funding decisions. At the NIH, ordinary 26 Section 125290.20(a)(3). citizens participate in the funding process through service on an Institute’s Council of Public Representatives. The ICOC’s composition guarantees an even broader community perspective, and brings that perspective directly into the decision-making process. Collectively, the disease advocacy representatives provide informed public input into decisions about how stem cell research projects are best prioritized. That function is bolstered by other provisions of the Act, which authorize issuance of majority and minority reports to the public when significant disagreement exists within the peer review advisory process on funding decisions, as well as public hearings to air those disagreements.27
Proposition 71 establishes a constitutionally valid process for allocating the $3 billion in stem cell research funds authorized by California’s voters. Proposition 71’s dedication to a peer review, merits-based decision-making process will help ensure that the public’s money is spent wisely, on those research programs most likely to bear meaningful fruit and to bear it soon. Amici agree with Defendants that nothing in our Constitution precludes the people from adopting such a
27 Section 125290.50(d).
system for funding scientific research. Accordingly, Defendants’ motion for a Judgment on the Pleadings should be granted.
California Institute of Technology, Keck Graduate
Institute, The Board of Trustees of the Leland
Stanford Junior University, University of Southern
California, Burnham Institute for Medical Research,
Cedars-Sinai Medical Center, Children’s Hospital
Los Angeles, Children's Hospital & Research
Center at Oakland, City of Hope, Salk Institute for
Biological Studies, Alliance for Aging Research,
Research & Prevention Foundation, Christopher
Reeve Foundation, Cystic Fibrosis Research, Inc.,
Juvenile Diabetes Research Foundation, The
Leukemia & Lymphoma Society, Michael J. Fox
Foundation for Parkinson's Research, National
Brain Tumor Foundation, National Multiple
Sclerosis Society, Parkinson's Action Network, San
Francisco AIDS Foundation, Southern California
Biomedical Council, Dr. Paul Berg, Nobel Laureate