Proposition 71 of 2004 (or the California Stem Cell Research and Cures Act) is a law enacted by California voters to support stem cell research in the state. It was proposed by means of the initiative process and approved in the 2004 state elections on November 2. The Act amended both the Constitution of California and the Health and Safety Code.
In political science, an initiative is a means by which a petition signed by a certain minimum number of registered voters can force a public vote in parliament called an indirect initiative or via a direct initiative, the latter then being dubbed a Popular initiated Referendum.
The Constitution of California is the primary organizing law for the U.S. state of California, describing the duties, powers, structures and functions of the government of California. Following cession of the area from Mexico to the United States in the Treaty of Guadalupe Hidalgo that ended the Mexican–American War, California's original constitution was drafted in both English and Spanish by delegates elected on August 1, 1849, to represent all communities home to non-indigenous citizens. The delegates wrote and adopted the constitution at the 1849 Constitutional Convention, held beginning on September 3 in Monterey, and voters approved the new constitution on November 13, 1849. Adoption of the "state" constitution actually preceded California's Admission to the Union on September 9, 1850 by almost ten months.
The Act makes conducting stem cell research a state constitutional right. It authorizes the sale of general obligation bonds to allocate three 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.
Stem cells are cells that can differentiate into other types of cells, and can also divide in self-renewal to produce more of the same type of stem cells.
A constitutional right can be a prerogative or a duty, a power or a restraint of power, recognized and established by a sovereign state or union of states. All constitutional rights are expressly stipulated and written in a consolidated national constitution, which is the supreme law of the land, meaning that any other laws which are in contradiction with it are considered unconstitutional and thus regarded as invalid. Usually any constitution defines the structure, functions, powers, and limits of the national government and the individual freedoms, rights, and obligations which will be protected and enforced when needed by the national authorities.
In finance, a bond is an instrument of indebtedness of the bond issuer to the holders. The most common types of bonds include municipal bonds and corporate bonds.
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 Act also establishes a governing body called the Independent Citizen’s Oversight Committee (ICOC) to oversee CIRM.
The California Institute for Regenerative Medicine (CIRM) was created in 2004 after 59% of California voters approved California Proposition 71, which allocated $3 billion to fund stem cell research in California.
Proposition 71 is unique in at least three ways. Firstly, it uses general obligation bonds, which are usually used to finance brick-and-mortar projects such as bridges or hospitals, to fund scientific research. Secondly, by funding scientific research on such a large scale, California is taking on a role that is typically fulfilled by the U.S. federal government. Thirdly, Proposition 71 establishes the state constitutional right to conduct stem cell research. The initiative also represents a unique instance where the public directly decided to fund scientific research.
A general obligation bond is a common type of municipal bond in the United States that is secured by a state or local government's pledge to use legally available resources, including tax revenues, to repay bond holders.
The Federal Government of the United States is the national government of the United States, a federal republic in North America, composed of 50 states, a federal district, five major self-governing territories, and several island possessions. The federal government is composed of three distinct branches: legislative, executive, and judicial, whose powers are vested by the U.S. Constitution in the Congress, the President, and the federal courts, respectively. The powers and duties of these branches are further defined by acts of congress, including the creation of executive departments and courts inferior to the Supreme Court.
Proposition 71 states that "This measure shall be known as the California Stem Cell Research and Cures Act”. That is therefore the official citation. However the measure is also headed as the California Stem Cell Research and Cures Initiative. [2] The Act is long and complex. It amends the state constitution by adding "Article 35 – Medical Research". This article establishes the CIRM and guarantees a right to conduct stem cell research. Proposition 71 also amends the Health and Safety Code, by introducing a provision in Part 5 of Division 106 called "Chapter 3 – California Stem Cell Research and Cures Bond Act". This chapter, among other provisions, establishes the ICOC.
CIRM may have up to 50 employees, who are exempt from civil service. CIRM is divided in three working groups.
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". [3] Since then, this type of research has sparked intense controversy in the United States.
The United States of America (USA), commonly known as the United States or America, is a country composed of 50 states, a federal district, five major self-governing territories, and various possessions. At 3.8 million square miles, the United States is the world's third or fourth largest country by total area and is slightly smaller than the entire continent of Europe's 3.9 million square miles. With a population of over 327 million people, the U.S. is the third most populous country. The capital is Washington, D.C., and the largest city by population is New York City. Forty-eight states and the capital's federal district are contiguous in North America between Canada and Mexico. The State of Alaska is in the northwest corner of North America, bordered by Canada to the east and across the Bering Strait from Russia to the west. The State of Hawaii is an archipelago in the mid-Pacific Ocean. The U.S. territories are scattered about the Pacific Ocean and the Caribbean Sea, stretching across nine official time zones. The extremely diverse geography, climate, and wildlife of the United States make it one of the world's 17 megadiverse countries.
Ever since 1996, Congress has attached to the Health and Human Services appropriations bill (which regulates the funding for the National Institutes of Health) a provision known as the "Dickey–Wicker Amendment". This amendment, named after the former representative Jay Dickey, Republican from Arkansas, prohibits the use of federal monies to fund "research that destroys or seriously endangers human embryos, or creates them for research purposes". [4]
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". [4] 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 small 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 represents a response to the federal policy. The idea for this proposition came about after the California legislature blocked a billion-dollar measure to fund stem cell research. Robert N. 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 three million dollars of his own money in the campaign.
The Coalition for Stem Cell Research and Cures comprised a broad group of people and organizations that included: 22 Nobel laureates; celebrities such as Christopher Reeve, Sharyn Rossi, Monica Siegenthaler, Brad Pitt, Saba Motakef, and Michael J. Fox; a number of elected officials such as State Treasurer Phil Angelides, and State Controller Steve Westly, and State Senator Deborah Ortiz; more than fifty patient and disease advocacy groups (e.g., Juvenile Diabetes Research Foundation, Alzheimer's Association California Council, Sickle Cell Disease Foundation of California), medical groups and hospitals (e.g., California Medical Association, Children's Hospital-Los Angeles), groups representing Latinos and African Americans (e.g. National Coalition of Hispanic Organization, California NAACP), women's advocacy groups (e.g., Planned Parenthood, California NOW) and faith-based organizations (e.g. Catholics for a Free Choice).
The Republican Party opposed this initiative, but two key Republican figures endorsed it. They were George P. Shultz, the U.S. 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 $25 million. The contributors included such prominent figures as Bill Gates, who donated $400,000; Pierre M. and Pamela Omidyar, the founders of eBay who together gave $1 million; Gordon Gund, the owner of the Cleveland Cavaliers basketball team, who contributed $1 million; Herbert M. Sandler, chairman of the board of World Savings Bank, who gave $500,000; John Doerr, a Silicon Valley venture capitalist, who donated $2 million; and William Bowes Jr., a founder of Amgen (a biotech company), who gave $600,000.
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 Moorlach. The Hollywood actor Mel Gibson also joined the efforts to defeat this initiative. Conservative groups, however, were not the only ones opposing Prop. 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 almost $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.
Initial analysis and discussion of need for analysis was done in 2007 [5]
Sociologist Ruha Benjamin offers the first in-depth analysis of Proposition 71 in People's Science: Bodies and Rights on the Stem Cell Frontier (Stanford University Press 2013). Too frequently the debate over stem cell research devolves in to simple judgments—good or bad, life-saving medicine or bioethical nightmare, symbol of human ingenuity or our fall from grace—ignoring the people affected. Benjamin moves the terms of debate to focus on the shifting relationship between science and society, on the people who benefit—or don't—from Proposition 71 and what this says about democratic commitments to an equitable society. Benjamin discusses issues of race, disability, gender, and socio-economic class that serve to define certain groups as more or less deserving in their political aims and biomedical hopes.
Choice | Votes | % |
---|---|---|
7,018,059 | 59.05 | |
No | 4,867,090 | 40.95 |
Valid votes | 11,885,149 | 94.40 |
Invalid or blank votes | 704,534 | 5.60 |
Total votes | 12,589,683 | 100.00 |
Registered voters and turnout | 16,557,273 | 76.04 |
Human cloning is the creation of a genetically identical copy of a human. The term is generally used to refer to artificial human cloning, which is the reproduction of human cells and tissue. It does not refer to the natural conception and delivery of identical twins. The possibility of human cloning has raised controversies. These ethical concerns have prompted several nations to pass laws regarding human cloning and its legality.
In genetics and developmental biology, somatic cell nuclear transfer (SCNT) is a laboratory strategy for creating a viable embryo from a body cell and an egg cell. The technique consists of taking an enucleated oocyte and implanting a donor nucleus from a somatic (body) cell. It is used in both therapeutic and reproductive cloning. Dolly the Sheep became famous for being the first successful case of the reproductive cloning of a mammal. In January 2018, a team of scientists in Shanghai announced the successful cloning of two female crab-eating macaques from fetal nuclei. "Therapeutic cloning" refers to the potential use of SCNT in regenerative medicine; this approach has been championed as an answer to the many issues concerning embryonic stem cells (ESC) and the destruction of viable embryos for medical use, though questions remain on how homologous the two cell types truly are.
Embryonic stem cells are pluripotent stem cells derived from the inner cell mass of a blastocyst, an early-stage pre-implantation embryo. Human embryos reach the blastocyst stage 4–5 days post fertilization, at which time they consist of 50–150 cells. Isolating the embryoblast, or inner cell mass (ICM) results in destruction of the blastocyst, a process which raises ethical issues, including whether or not embryos at the pre-implantation stage should have the same moral considerations as embryos in the post-implantation stage of development. Researchers are currently focusing heavily on the therapeutic potential of embryonic stem cells, with clinical use being the goal for many labs. Potential uses include the treatment of diabetes and heart disease. The cells are being studied to be used as clinical therapies, models of genetic disorders, and cellular/DNA repair. However, adverse effects in the research and clinical processes such as tumours and unwanted immune responses have also been reported.
JDRF is a nonprofit 501(c)(3) organization that funds type 1 diabetes (T1D) research and advocates for regulation favorable to medical research and that makes it easier to market new medical devices. It was formerly called the Juvenile Diabetes Research Foundation.
A stem cell line is a group of stem cells that is cultured in vitro and can be propagated indefinitely. Stem cell lines are derived from either animal or human tissues and come from one of three sources: embryonic stem cells, adult stem cells, or induced stem cells. They are commonly used in research and regenerative medicine.
The stem cell controversy is the consideration of the ethics of research involving the development, use, and destruction of human embryos. Most commonly, this controversy focuses on embryonic stem cells. Not all stem cell research involves human embryos. For example, adult stem cells, amniotic stem cells, and induced pluripotent stem cells do not involve creating, using, or destroying human embryos, and thus are minimally, if at all, controversial. Many less controversial sources of acquiring stem cells include using cells from the umbilical cord, breast milk, and bone marrow, which are not pluripotent.
The Alliance for Aging Research is a non-profit organization based in Washington, D.C. that was founded to promote medical research to improve the human experience of aging. Founded in 1986 by Daniel Perry, the Alliance also advocates and implements health education for consumers and health professionals.
The National Psoriasis Foundation (NPF) is the world's largest nonprofit organization serving people with psoriasis and psoriatic arthritis. NPF provides information and services to help people take control of their condition, while supporting research to find a cure. In addition to serving more than 3 million people annually through patient and professional health education and advocacy initiatives, the National Psoriasis Foundation has funded more than $12 million in psoriatic disease research grants and fellowships.
City of Hope is a private, not-for-profit clinical research center, hospital and graduate medical school located in Duarte, California, United States. The center's main campus resides on 110 acre of land adjacent to the boundaries of Duarte and Irwindale, with a network of clinical practice locations throughout Southern California, satellite offices in Monrovia and Irwindale, and regional fundraising offices throughout the United States.
Eva Lucille Feldman, M.D., Ph.D., F.A.A.N., F.A.N.A. is an American physician and the Russell N. DeJong Professor of Neurology at the University of Michigan. She is the Director of the Program for Neurology Research and Discovery, and Research Director of the University of Michigan ALS Center of Excellence. She is annually listed in Best Doctors in America, is a Past President of the Peripheral Nerve Society and the American Neurological Association, and a member of the National Academy of Medicine and Association of American Physicians.
The New York Stem Cell Foundation (NYSCF) is an American 501(c)(3) nonprofit organization, founded in the Spring of 2005, with the mission “accelerating cures for the major diseases of our time through stem cell research.” NYSCF established the first privately funded stem cell laboratory in New York City, where NYSCF researchers and scientific collaborators conduct advanced stem cell investigations. The foundation supports stem cell scientists through the NYSCF Innovator Program, and it engages the academic, medical, pharmaceutical, and biotechnology communities by hosting the annual translational stem cell research conference and other symposia throughout the year. NYSCF aims to educate the public on the importance of stem cell research in new therapies.
Royan Institute is an Iranian clinical, research and educational institute dedicated to biomedical, translational and clinical researches, stem cell research and infertility treatment. It is a public non-profitable organization affiliated to Academic Center for Education, Culture and Research. It was established in 1991 by the late Dr. Saeid Kazemi Ashtiani as a research institute for Reproductive Biomedicine and infertility treatments. In 1998 this institute was approved by Ministry of Health as Cell Based Research Center with over 46 scientific members and 186 lab technicians.
Robert Nicholas "Bob" Klein II, 71, is a stem cell advocate. He initiated California Proposition 71, which succeeded in establishing the California Institute for Regenerative Medicine, of which Klein is now the head.
Stem cell laws are the law rules, and policy governance concerning the sources, research, and uses in treatment of stem cells in humans. These laws have been the source of much controversy and vary significantly by country. In the European Union, stem cell research using the human embryo is permitted in Sweden, Spain, Finland, Belgium, Greece, Britain, Denmark and the Netherlands; however, it is illegal in Germany, Austria, Ireland, Italy, and Portugal. The issue has similarly divided the United States, with several states enforcing a complete ban and others giving support. Elsewhere, Japan, India, Iran, Israel, South Korea, China, and Australia are supportive. However, New Zealand, most of Africa, and most of South America are restrictive.
Stem cell laws and policy in the United States have had a complicated legal and political history.
Proposition 29, the California Cancer Research Act, is a California ballot measure that was defeated by California voters at the statewide election on June 5, 2012.
The Food and Drug Administration (FDA) approved the first clinical trial in the United States involving human embryonic stem cells on January 23, 2009. Geron Corporation, a biotechnology firm located in Menlo Park, California, originally planned to enroll ten patients suffering from spinal cord injuries to participate in the trial. The company hoped that GRNOPC1, a product derived from human embryonic stem cells, would stimulate nerve growth in patients with debilitating damage to the spinal cord. The trial began in 2010 after being delayed by the FDA because cysts were found on mice injected with these cells, and safety concerns were raised.
Paul S. Knoepfler is an American biologist, writer, and blogger. He is a professor in the Department of Cell Biology and Human Anatomy, the Genome Center, and the Comprehensive Cancer Center at the University of California, Davis School of Medicine. In 2013, Knoepfler was named one of the 50 most influential people in the stem cell field.
Jan A. Nolta is an American scientist and the director of the stem cell program at the UC Davis School of Medicine and Institute for Regenerative Cures. She is Scientific Director for the UC Davis Good Manufacturing Practice and editor of the journal Stem Cells. Nolta is known for her work with stem cell-related regenerative medicine. Nolta's current research focuses on treatment of Huntington's disease using mesenchymal stem cells.