California Proposition 71, Stem Cell Research (2004)

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California Proposition 71 was on the November 2, 2004 general election ballot in California as an initiated constitutional amendment. Voters approved it. The measure has been codified as Article XXXV of the California Constitution and is also known as the California Stem Cell Research and Cures Initiative.

The initiative makes conducting stem cell research a state constitutional right. It authorized the sale of general obligation bonds to allocate $3 billion dollars over a period of ten years to stem cell research and research facilities. Although the funds could be used to finance all kinds of stem cell research, it gives priority to human embryonic stem cell research.

Proposition 71 created the California Institute for Regenerative Medicine (CIRM), which is in charge of making “grants and loans for stem cell research, for research facilities, and for other vital research opportunities to realize therapies” as well as establishing “the appropriate regulatory standards of oversight bodies for research and facilities development.”[1] The initiative also established a governing body called the Independent Citizen’s Oversight Committee (ICOC) to oversee CIRM.

Election results

Proposition 71
ResultVotesPercentage
Approveda Yes 7,018,059 59.1%
No4,867,09040.9%

Aftermath

The funding generated by the $3 billion in bonds authorized by Proposition 71 is expected to allow the agency it created (CIRM) to continue to give new grants through 2016 or 2017. The grants are typically multi-year grants, which means that the last money would actually be spent in about 2021.[2]

In 2011, CIRM's first chairman, Robert Klein, began talking about going back to the voters to get more money for stem cell research.

Accomplishments

An Associated Press review of the agency's accomplishments published in March 2012 said that the main accomplishments so far are:

  • "the opening of sleek buildings and gleaming labs at a dozen private and public universities built with matching funds."
  • "Stanford University unveiled the nation’s largest space dedicated to stem cell research — 200,000 square feet that can hold 550 researchers."
  • "There are no cures yet in the pipeline and CIRM has shifted focus, channeling money to projects with the most promise of yielding near-term results."[2]

Reality vs expectations

Has the CIRM lived up to its promise?

  • According to Roger Noll, professor emeritus of economics at Stanford, "CIRM spent a lot of money and there’s a lot of stuff going on, but it’s too early to know whether it was worth it."[2]
  • John Simpson of Consumer Watchdog says, "The impression you got was, if you just passed this bond measure, Christopher Reeve will be jumping out of his wheelchair and walking next week. They’re having to live down the super high expectations that they raised."[2]

Michael Hiltzik, a columnist for the Los Angeles Times, wrote in 2012 that Proposition 71 "was sold to a gullible public via candy-coated images of Christopher Reeve walking again and Michael J. Fox cured of Parkinson's...The implication was that these miracles would happen if voters approved a $3-billion bond issue for stem cell research."[3]

Alan Trounson and Jonathan Thomas, the president and chairman of the stem cell program, objected to Hiltzik's characterization. They said, "No ads for Proposition 71 promised miraculous cures."

Hiltzik then wrote another column reviewing the ads used in the campaign. The ads included this material:

  • Christopher Reeves saying in an ad, "Stem cells have already cured paralysis in animals. Stem cells are the future of medicine."
  • Michael J. Fox saying in an ad, "Vote yes on 71, and save the life of someone you love."
  • Joan Samuelson, a Parkinson's patient advocate, saying in an ad, "There are more Americans than I think we can count who are sick now, or are going to be sick in the future, whose lives will be saved by Prop. 71."[3]

Hiltzik concluded from this review of the ads:

"Yes, this is the language of advertising, not research, but for Trounson and Thomas to pretend that the ad campaign somehow promised merely "good science" and not specific outcomes, as their letter suggested, is (at least) miraculously disingenuous. The campaign made a direct link between the creation of the $3-billion stem cell program and the discovery of definitive cures for specific diseases. It's true that science takes time and patience, but you wouldn't have known that from the Proposition 71 ad campaign."[3]

Geron Corp.

CIRM had loaned Geron Corp. $25 million to support a trial of the use of embryonic stem cells to heal spinal cord injuries. This was the first embryonic stem cell medical trial approved in the U.S. In 2011, Geron Corp. announced that it was abandoning that trial, and the embryonic stem cell field altogether. This was regarded as a blow to CIRM.[2]

The Los Angeles Times reported that the day after Geron announced that it was abandoning research on stem cells, "Geron's shares fell 20% the next day, but that was probably nothing compared with how far spirits must have fallen at the California stem cell agency, which just a few months earlier had made its highest-profile investment ever by awarding Menlo Park-based Geron a $25-million loan to help fund the first human trial of stem cell-based spinal cord therapy."[4]

Conflicts of interest

By December 2012, CIRM had handed out $1.7 billion. 90% of this money went to institutions with representatives who sit on the CIRM board.

The editorial board of the Sacramento Bee wrote, "The built-in conflicts have become all too apparent. In 2007, the CEO of the Sanford-Burnham Medical Research Institute in San Diego, a member of CIRM's oversight board, intervened to endorse a grant application to his institution. The incident – brought to light by David Jensen, the dogged author of the California Stem Cell Report blog – eventually led to the disqualification of grant applications from 10 institutions that were the focus of improper lobbying by oversight board members."[5]

CIRM paid $700,000 to the National Academy of Science to have a report done by its Institute of Medicine on how CIRM functions. This report recommended a number of steps CIRM can take to eliminate conflicts of interest in how it gives out grants. The Sacramento Bee wrote, "if it fails in that task, it will only affirm the view of many voters that they should never again endorse a California research initiative, especially one like Prop. 71 that lacks proper controls and accountability over taxpayer dollars."[5]

Howard Shapiro, a former president of Princeton University, chaired the panel at the Institute of Medicine that wrote the report on CIRM issued in December 2012. He said, "The kind of conflicts that exist now are very direct and very major." Shapiro also said, "They make proposals to themselves, essentially, regarding what should be funded...They cannot exert independent oversight."[6][7]

Jonathan Shestack, a member of the CIRM board, rejected the report from the Institute of Medicine (IOM), saying, "I don't believe the (report's) conclusions on conflicts of interest or bias could be more incorrect. There isn't a whiff of bias, actually."[7]

In late January 2013, CIRM said it would make some changes to respond to the report from the Institute of Medicine. However, CIRM's board rejected the most significant of the IOM's recommendations regarding conflicts-of-interest. This led Michael Hiltzik, a columnist at the Los Angeles Times, to write, "The CIRM board has never done more than pay lip service to its duty of public accountability...Shapiro's recommendations showed CIRM the path to cleansing itself of its aura of connivance and influence trading. That the board can't even bring itself to place the proposals before the voters or their elected representatives only shows how much money it's willing to waste to keep living in its own little world."[8]

The new Institute

The California Institute for Regenerative Medicine (CIRM) employs 50 people and has an annual operating budget of about $18 million.[2]

Citizen’s Oversight Committee

Members of the committee created by Proposition 71 -- the California Institute for Regenerative Medicine (CIRM) -- include:

Proposition 71 county vote distribution
  • (5 members) the chancellors of University of California at San Francisco, Davis, San Diego, Los Angeles, and Irvine.
  • (12 members) the Governor, the Lieutenant Governor, the Treasurer, and the Controller each appoints a member from each of the following three categories:
    • A California university, excluding the ones mentioned above.
    • A California nonprofit academic and research institution that is not part of the University of California.
    • A California life science commercial entity that is not actively engaged in researching or developing therapies with pluripotent or progenitor stem cells.
  • (2 members) the Governor appoints two members, each from the following disease advocacy groups: Alzheimer’s and spinal cord injury.
  • (2 members) the Lieutenant Governor appoints two members, each from the following disease advocacy groups: type II diabetes and multiple sclerosis, or amyotrophic lateral sclerosis.
  • (2 members) the Treasurer appoints two members, each from the following disease advocacy groups: type I diabetes and heart disease.
  • (2 members) the Controller appoints two members, each from the following disease advocacy groups: cancer and Parkinson’s disease.
  • (1 member) the Speaker of the Assembly appoints a member from a mental health disease advocacy group.
  • (1 member) the President pro Tempore of the Senate appoints a member from a HIV/AIDS disease advocacy group.
  • (2 members) A chairperson and vice chairperson who shall be elected by the ICOC members.

Institute of Regenerative Medicine

Members of this committee include:

CIRM may have up to 50 employees, who are exempt from civil service. CIRM is divided in three working groups.

  • Scientific and Medical Research Funding Working Group; has 23 members:
    • Seven ICOC patient advocates who must be from California.
    • Fifteen stem-cell experts who cannot be from California.
    • The ICOC chair.
  • Scientific and Medical Accountability Standards Working Group; has 19 members:
    • Five ICOC patient advocates who must be from California.
    • Nine stem-cell experts.
    • Four ethicists.
    • The ICOC chair.
  • Scientific and Medical Research Facilities Working Group; has 11 members:
    • Six members from the Research Funding Work Group.
    • Four real estate specialists who must be from California.
    • The ICOC chair

Background

Human embryonic stem cell research became a public issue in 1998 when two teams of scientists developed “methods for culturing cell lines derived, respectively, from: (1) cells taken from the inner cell mass of early embryos, and (2) the gonadal ridges of aborted fetuses.”[9] Since then, this type of research has sparked intense controversy in the United States.

Ever since 1996, Congress has attached to the Health and Human Services appropriations bill—which regulates the funding for the National Institutes of Health (NIH)—a provision known as the “Dickey Amendment.” This amendment, named after the former representative Jay Dickey of Kansas, prohibits the use of federal monies to fund “research that destroys or seriously endangers human embryos, or creates them for research purposes.”[9]

In 1999, however, the General Counsel of the Department of Health and Human Services issued a legal opinion arguing, “that the wording of the law might permit an interpretation under which human embryonic stem cell research could be funded.”[9] This interpretation stipulated that the government could fund this research so long as the embryos used had been destroyed by researchers privately paid. Although the Clinton administration adopted this interpretation and wrote the corresponding guidelines, it did not have the time to enforce them. The issue would pass on to the next administration.

On August 9, 2001, President George W. Bush announced his administration’s policy regarding human embryonic stem cell research. The President opted to fund only research on the existing 60 cell lines. The large number of cell lines quoted by the President surprised many scientists. Furthermore, they were concerned about the availability and quality of these lines. Scientists also worried about the impact the president’s policy could have on the American research community. The United States, they argued, lags behind other countries where governments support stem cell research. This, in turn, could cause American scientists to move to these countries.

Proposition 71 represented a response to the President’s policy. The idea for this proposition came about after the California State Legislature blocked a billion-dollar measure to fund stem cell research. Robert Klein II, a real-estate developer from Palo Alto, whose son suffers from diabetes and whose mother has Alzheimer’s, became the leader of the campaign effort to pass Proposition 71, and spent two million dollars of his own money in the campaign.

Constitutional changes

Proposition 71 amended the California Constitution by adding Article XXXV.

Supporters

"Yes on 71" website banner

The main campaign effort for Proposition 71 was led by the "Coalition for Stem Cell Research and Cures." This organization included or was endorsed by 22 Nobel laureates; celebrities such as Christopher Reeve, Sharyn Rossi, Monica Siegenthaler, Brad Pitt, Saba Motakef, Bahereh Lajvardi and Michael J. Fox; a number of government officials such as California State Treasurer, Phil Angelides and California State Controller, Steve Westly; several state legislators such as State Senator Deborah Ortiz; more than 50 patient and disease advocacy groups; medical groups and hospitals, and groups representing Latinos and African Americans.

The Republican Party opposed Proposition 71, but two key Republican figures endorsed it. They were George P. Shultz, a secretary of state in the Reagan administration and California Governor Arnold Schwarzenegger. Although Schwarzenegger did not endorse it until October 18, 2004, his support may have helped to solidify the proposition’s lead in the polls.

This campaign raised approximately $34 million. The contributors included:

  • Robert Klein: $3 million
  • John Doerr III: $1.9 million
  • Marion and Herb Sandler: $1.18 million
  • Juvenile Diabetes Research Fund: $1 million
  • Pierre M. and Pamela Omidyar, the founders of eBay: $1 million
  • Gordon Gund, the owner of the Cleveland Cavaliers basketball team: $1 million
  • William Bowes Jr., a founder of Amgen: $600,000.
  • Bill Gates: $400,000[10]

Opposition

Website banner of "No on 71" campaign

Those who opposed Proposition 71 included the Roman Catholic Church, Orange County Republicans, and the California Pro-Life Council, an affiliate of the National Right to Life Committee. Among the politicians in this group were State Senator Tom McClintock (R-Thousand Oaks) and Orange County Treasurer-Tax Collector John M.W.Moorlah. The Hollywood actor[Mel Gibson also joined the efforts to defeat this initiative. Conservative groups, however, were not the only ones opposing Proposition 71; organizations such as the California Nurses Association (CNA), the Green Party, the Center for Genetics and Society, Our Bodies Ourselves, among others, were also against the initiative.

Two prominent groups campaigning to defeat the initiative were the Pro-Choice Alliance Against Proposition 71 and Doctors, Patients, and Taxpayers for Fiscal Responsibility. These two groups lacked the wide range of endorsements that the proponents had (however, the Pro-Choice Alliance Against Proposition 71 was endorsed by seven organizations and a number of university professors). On the Doctors, Patients, and Taxpayers for Fiscal Responsibility website (which no longer exists) there were only fourteen members listed. Among these members were Dr. Vincent Fortanasce, a physician; Diane Beeson, a medical sociologists; Carol Hogan, a spokesperson for the California Catholic Bishops; and Dr. H Rex Greene, an oncologist and hospital administrator.

The four organizations campaigning against the initiative raised about $400,000. The main contributors were the United States Conference of Catholic Bishops, which donated $50,000 and Howard Ahmanson Jr., founder and president of Fieldstead & Company, who gave $95,000.[11]

Relevance

Proposition 71 is unique in at least three ways. First, it uses general obligation bonds, which are usually used to finance brick-and-mortar projects such as bridges or hospitals, to fund scientific research. Second, by funding scientific research on such a large scale, California is taking on a role that is typically fulfilled by the federal government. And third, Proposition 71 establishes the state constitutional right to conduct stem cell research. This initiative also represents a unique instance where the public directly decided to fund scientific research.

Text of measure

Title

The ballot title was:

Stem Cell Research. Funding. Bonds. Initiative Constitutional Amendment and Statute.

Question

The question on the ballot was:

"Should the "California Institute for Regenerative Medicine" be established to regulate and fund stem cell research with the constitutional right to conduct such research and with an oversight committee? Prohibits funding of human reproductive cloning research."

Summary

The summary of the ballot measure prepared by the California Attorney General said:

  • Establishes "California Institute for Regenerative Medicine" to regulate stem cell research and provide funding, through grants and loans, for such research and research facilities.
  • Establishes constitutional right to conduct stem cell research; prohibits Institute's funding of human reproductive cloning research.
  • Establishes oversight committee to govern Institute.
  • Provides General Fund loan up to $3 million for Institute's initial administration/implementation costs.
  • Authorizes issuance of general obligation bonds to finance Institute activities up to $3 billion subject to annual limit of $350 million.
  • Appropriates monies from General Fund to pay for bonds.

Fiscal impact

See also: Fiscal impact statement

The California Legislative Analyst's Office provided an estimate of net state and local government fiscal impact for Proposition 71. That estimate was:

  • State cost of about $6 billion over 30 years to pay off both the principal ($3 billion) and interest ($3 billion) on the bonds. Payments averaging about $200 million per year.
  • Unknown potential state and local revenue gains and cost savings to the extent that the research projects funded by this measure result in additional economic activity and reduced public health care costs.

External links

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Stem cell agency websites:

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References