Stem cell laws and policy in the United States have had a complicated legal and political history.
Science background
Stem cells are cells found in all multi-cellular organisms. They were isolated in mice in 1981, and in humans in 1998.John Ydstie and Joe Palca, "Embryonic Stem Cells Made Without Embryos," NPR, November 21, 2007, found at NPR website story of 11-21-09. Retrieved April 8, 2009. In humans there are many types of stem cells, each with varying levels of potency. Potency is a measure of a cell's differentiation potential, or the number of other cell types that can be made from that stem cell. Embryonic stem cells are pluripotent stem cells derived from the inner cell mass of the blastocyst. These stem cells can differentiate into all other cells in the human body and are the subject of much scientific research. However, since they must be derived from early human embryos their production and use in research has been a hotly debated topic.
Stem cell treatments are a type of cell therapy that introduce new cells into adult bodies for possible treatment of cancer, diabetes, neurological disorders and other medical conditions. Stem cells have been used to repair tissue damaged by disease or age.Joe Neel and Joanne Silberner"Stem Cells Used In Woman's Windpipe Transplant," All Things Considered, November 18, 2009, found at NPR story of 11-18-2008. Retrieved April 8, 2009. Cloning also might be done with stem cells. Pluripotent stem cells can also be derived from Somatic cell nuclear transfer which is a laboratory technique where a clone embryo is created from a donor nucleus. Somatic cell nuclear transfer is also tightly regulated amongst various countries.
Until recently, the principal source of human embryonic stem cells has been donated embryos from fertility clinics. In January 2007, researchers at Wake Forest University reported that "stem cells drawn from amniotic fluid donated by pregnant women hold much of the same promise as embryonic stem cells."
In 2000, the NIH, under the administration of President Bill Clinton, issued "guidelines that allow federal funding of embryonic stem-cell research."
Political beginnings In 1973, Roe v. Wade legalized abortion in the United States. Five years later, the first successful human in vitro fertilization resulted in the birth of Louise Brown in England. These developments prompted the federal government to create regulations barring the use of federal funds for research that experimented on human embryos. ISSN:1549-3199. LCCN:2004212209. OCLC:. In 1995, the NIH Human Embryo Research Panel advised the administration of President Bill Clinton to permit federal funding for research on embryos left over from in vitro fertility treatments and also recommended federal funding of research on embryos specifically created for experimentation. In response to the panel's recommendations, the Clinton administration, citing moral and ethical concerns, declined to fund research on embryos created solely for research purposes, but did agree to fund research on left-over embryos created by in vitro fertility treatments. At this point, the Congress intervened and passed the Dickey–Wicker Amendment in 1995 (the final bill, which included the Dickey Amendment, was signed into law by Bill Clinton) which prohibited any federal funding for the Department of Health and Human Services be used for research that resulted in the destruction of an embryo regardless of the source of that embryo. In 1998, privately funded research led to the breakthrough discovery of human Embryonic stem cells (hESC).
Federal law No federal law ever did ban stem cell research in the United States, but only placed restrictions on funding and use, under Congress's power to spend.
In February 2001, George W. Bush requested a review of the NIH's guidelines, and after a policy discussion within his circle of supporters, implemented a policy in August of that year to limit the number of embryonic stem cell lines that could be used for research. (While he claimed that 78 lines would qualify for federal funding, only 19 lines were actually available.)
In April 2004, 206 members of Congress, including many moderate Republicans, signed a letter urging President Bush to expand federal funding of embryonic stem cell research beyond what Bush had already supported.
In May 2005, the House of Representatives voted 238-194 to loosen the limitations on federally funded embryonic stem-cell research — by allowing government-funded research on surplus frozen embryos from in vitro fertilization clinics to be used for stem cell research with the permission of donors — despite Bush's promise to veto if passed. On July 29, 2005, Senate Majority Leader William H. Frist (R-TN), announced that he too favored loosening restrictions on federal funding of embryonic stem cell research. On July 18, 2006, the Senate passed three different bills concerning stem cell research. The Senate passed the first bill, 63-37, which would have made it legal for the Federal government to spend Federal money on embryonic stem cell research that uses embryos left over from in vitro fertilization procedures. On July 19, 2006, President Bush vetoed this bill. The second bill makes it illegal to create, grow, and abort fetuses for research purposes. The third bill would encourage research that would isolate pluripotent, i.e., embryonic-like, stem cells without the destruction of human embryos.
The National Institutes of Health has hundreds of funding opportunities for researchers interested in hESC. In 2005 the NIH funded $607 million worth of stem cell research, of which $39 million was specifically used for hESC.
During Bush's second term, in July 2006, he used his first Presidential veto on the Stem Cell Research Enhancement Act. The Stem Cell Research Enhancement Act was the name of two similar bills, and both were vetoed by President George W. Bush and were not enacted into law. New Jersey congressman Chris Smith wrote a Stem Cell Therapeutic and Research Act of 2005, which was signed into law by President Bush. It provided $265 million for adult stem cell therapy, umbilical cord blood and bone marrow treatment, and authorized $79 million for the collection of cord blood stem cells.
By executive order on March 9, 2009, President Barack Obama removed certain restrictions on federal funding for research involving new lines of human embryonic stem cells.Obama overturns Bush policy on stem cells on CNN, Added April 14, 2009, Prior to President Obama's executive order, federal funding was limited to non-embryonic stem cell research and embryonic stem cell research based upon embryonic stem cell lines in existence prior to August 9, 2001. Federal funding originating from current appropriations to the Department of Health and Human Services (including the National Institutes of Health) under the Omnibus Appropriations Act of 2009, remains prohibited under the Dickey–Wicker Amendment for (1) the creation of a human embryo for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero.
In a speech before signing the executive order, President Obama noted the following:
In 2011, a United States District Court "threw out a lawsuit that challenged the use of federal funds for embryonic stem cell research." The decision was a case on remand from the United States Court of Appeals for the District of Columbia Circuit.Sherley v. Sebelius, No. 10-5287, D. C. Cir. April 29, 2011), found at US Court of Appeals for the District of Columbia Circuit website.
State law
Legalization and funding S1909/A2840 is a bill that was passed by the New Jersey legislature in December 2003, and signed into law by Governor James McGreevey on January 4, 2004, that permits human cloning for the purpose of developing and harvesting human stem cells. Specifically, it legalizes the process of cloning a human embryo, and implanting the clone into a womb, provided that the clone is then aborted and used for medical research. Missouri Constitutional Amendment 2 (2006) (Missouri Amendment Two) was a 2006 law that legalized certain forms of embryonic stem cell research in the state.
California voters in November 2004 approved Proposition 71, creating a US$3 billion state taxpayer-funded institute for stem cell research, the California Institute for Regenerative Medicine. It hopes to provide $300 million a year. However, as of June 6, 2006, there were delays in the implementation of the California program and it is believed that the delays will continue for the significant future. On July 21, 2006, Governor Arnold Schwarzenegger (R-Calif.) authorized $150 million in loans to the Institute in an attempt to jump start the process of funding research.
Several states, in what was initially believed to be a national migration of biotech researchers to California, have shown interest in providing their own funding support of embryonic and adult stem cell research. These states include Connecticut,http://wireservice.wired.com/wired/story.asp?section=Breaking&storyId=1042210&tw=wn_wire_story Florida, Illinois, Massachusetts,http://wireservice.wired.com/wired/story.asp?section=RelatedStories&pitem=AP%2DMassachusetts+Stem+Cells&rev=20050531&pub_tag=APONLINE&relatedTo=1042210&from=relatedstory&rsNum=1 Missouri, New Hampshire, New York, Pennsylvania, Texas Around The Area, Washington, and Wisconsin.
Bans and restrictions
Other states have (or have shown interest in) additional restrictions or even complete bans on embryonic stem cell research. These states include Arkansas, Iowa, Kansas, Louisiana, Nebraska, North Dakota, South Dakota, and Virginia. Arkansas, Indiana, Louisiana, Michigan (subsequently reversed by constitutional amendment), North Dakota and South Dakota have passed laws to "prohibit the creation or destruction of human embryos for medical research."
States with statutes specifically banning human reproductive and therapeutic cloning Arkansas, [2003 SB 185]; Ark. Code § 20- 16-1001 et. seq. (2004) Indiana, Ind. Code § 1 6-18-2-5.5. -56.5, -128.5, -183.5 (2005) Michigan, Mich. Comp. Laws §§ 333.26401-06, 333.16274, 16275, 20197, 750.430a (2004), reversed by constitutional amendment in proposal 2008-02. North Dakota, [2003 HB 1424]; N.D. Cent. Code §§ 12.1-39-01, 12.1-39-02 (2004) South Dakota, 2004 SB 184 Virginia, Va. Code Ann. §§ 32.1-162.21- .22 (2004) (unclear whether therapeutic cloning is included in the ban)
States with statutes specifically banning human reproductive cloning Iowa, Iowa Code §§ 707C (2007) Maryland, 2006 SB 144
States banning the use of public funding for reproductive and/or therapeutic cloning Arizona, HB 2221 (2005) (human reproductive and therapeutic cloning) Missouri, Mo. Rev. Stat. § 1.217 (2004) (human reproductive cloning)
States with statutes specifically allowing therapeutic cloning California, Cal. Bus. & Prof. §§ 16004, 16105; Cal. Health & Safety §§24185-24187 (2004) Missouri, Mo. Rev. Stat. § 1.217 (2004) New Jersey, [2003 SB 1909/2003 AB 2840]; N.J. Stat. § 2C:11A-1 (2004) Rhode Island, R.I. Gen. Laws §§ 23-16.4-1 - .4-4 (2004) (Sunset provision: July 7, 2010) Connecticut, Public Act 05-149 (2005)
Policy stances of political parties and politicians Policy stances on stem cell research of various political leaders in the United States have not always been predictable.