Stem cells policy and politics
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Stem cells: policy and politics. Mark M. Rasenick, Ph.D. Distinguished UIC Professor of Physiology & Biophysics and Psychiatry [email protected]

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Stem cells: policy and politics

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Stem cells: policy and politics

Mark M. Rasenick, Ph.D.

Distinguished UIC Professor of Physiology & Biophysics and Psychiatry

[email protected]

1995 President Bill Clinton signs a law known as the Dickey Amendment preventing the Department of Health and Human Services (HHS) from funding research that causes destruction of human embryos.

1996 Scottish scientists announce the birth of Dolly the sheep, the first animal cloned from an adult animal cell (July).

1997 Clinton appoints a presidential commission — the National Bioethics Advisory Commission — to study the ethics of human cloning. As a result of their findings, he signs a five-year moratorium on the use of federal funds for research involving cloning.

The California Legislature passes the first law banning reproductive cloning.

Stem Cell Timeline

1998 James A. Thomson and colleagues at the University of Wisconsin report the successful harvesting of human embryonic stem cells.

Michigan becomes first state to ban all human cloning, including research and therapeutic cloning.

2000 Louisiana enacts a law prohibiting all research involving surplus human embryos from fertilization clinics.

2001 President George W. Bush limits federal funding for embryonic stem-cell research to cells lines created before the date of his order, Aug. 9, 2001.

California becomes first state to enact a law establishing the legality of all forms of human embryonic stem-cell research, including cloning techniques known as somatic nuclear cell transfer (SCNT).

2002 Iowa enacts a Michigan-like prohibition on all forms of human cloning, including research and therapies.

Stem Cell Timeline (continued)

2003 Arkansas, North Dakota and South Dakota prohibit all forms of human cloning, including research and therapies.

2004 New Jersey becomes the first state to fund embryonic stem-cell research, appropriating $10 million over 10 years for research grants. It also enacts a law permitting human cloning for research purposes. (January)

California voters approve Proposition 71 (PDF), providing $3 billion in state funds over 10 years for stem-cell research. (November)

2005 Connecticut appropriates $100 million over 10 years for stem-cell research.

Illinois Gov. Rod Blagojevich (D) sets aside $10 million in existing public health funds for stem-cell research.

Massachusetts legislature overrides a veto by Gov. Mitt Romney (R) to permit human cloning for research purposes.

2006 Maryland appropriates $15 million for stem-cell research.

Stem Cell Timeline (continued)

2006 cont. Bush vetoes a bill — the Stem Cell Research Enhancement Act of 2005 — aimed at lifting federal restrictions on funding of embryonic stem-cell research.

Missouri voters approve ballot measure amending the state constitution to guarantee scientists the right to conduct any stem-cell research allowed by the federal government and to ensure citizens the right to therapies that result.

2007 Iowa lifts ban on embryonic stem-cell research.

New York appropriates $600 million over 11 years to fund stem-cell research.

Massachusetts Gov. Deval Patrick (D) proposes a bill appropriating $1 billion for stem-cell research and other bioscience projects over 10 years

Bush vetoes a second bill that would lift federal funding restrictions on embryonic stem-cell research.

Massachusetts regulators reverse a rule adopted by former Gov. Romney that prevented scientists from using human embryos produced by in-vitro fertilization, even if the embryos were created out of the state.

Stem Cell Timeline (continued)

Legal with funding: California, Connecticut, Illinois, Maryland, New Jersey, New York and Wisconsin. Massachusetts likely soon.

Legal without funding: Iowa, Massachusetts and Missouri.

Prohibited or Restricted: Arkansas, Indiana, Louisiana, Michigan, North Dakota and South Dakota

States and Human Embryonic Stem Cell Research

`(1) HUMAN CLONING- The term `human cloning' means human asexual reproduction, accomplished by introducing nuclear material from one or more human somatic cells into a fertilized or unfertilized oocyte whose nuclear material has been removed or inactivated so as to produce a living organism (at any stage of development) that is genetically virtually identical to an existing or previously existing human organism.

`(b) Prohibition- It shall be unlawful for any person or entity, public or private, in or affecting interstate commerce, knowingly--

`(1) to perform or attempt to perform human cloning;

`(2) to participate in an attempt to perform human cloning; or

`(3) to ship or receive for any purpose an embryo produced by human cloning or any product derived from such embryo.

`(d) Penalties-

`(1) CRIMINAL PENALTY- Any person or entity that violates this section shall be fined or imprisoned for not more than 10 years, or both.

`(2) CIVIL PENALTY- Any person or entity that violates any provision of this section shall be subject to, in the case of a violation that involves the derivation of a pecuniary gain, a civil penalty of not less than $1,000,000 and not more than an amount equal to the amount of the gross gain multiplied by 2, if that amount is greater than $1,000,000.

Human Cloning Prohibition Act of 2007 S 1036: Brownback

No bills to regulate this have been introduced in Congress

> $1M US funds given to Snowflake Foundation for “embryo adoption”

La. Rev. Stat. Ann. § 9:126 An in vitro fertilized human ovum is a biological human being which is not the property of the physician which acts as an agent of fertilization, or the facility which employs him or the donors of the sperm and ovum. If the in vitro fertilization patients express their identity, then their rights as parents as provided under the Louisiana Civil Code will be preserved. If the in vitro fertilization patients fail to express their identity, then the physician shall be deemed to be temporary guardian of the in vitro fertilized human ovum until adoptive implantation can occur. A court in the parish where the in vitro fertilized ovum is located may appoint a curator, upon motion of the in vitro fertilization patients, their heirs, or physicians who caused in vitro fertilization to be performed, to protect the in vitro fertilized human ovum's rights.

Prohibition on discarding of embryos

  • S5 Stem Cell Research Enhancement Act of 2007 - (Sec. 2) Amends the Public Health Service Act to require the Secretary of Health and Human Services to conduct and support research that utilizes human embryonic stem cells, regardless of the date on which the stem cells were derived from a human embryo. Limits such research to stem cells that meet the following ethical requirements: (1) the stem cells were derived from human embryos donated from in vitro fertilization clinics for the purpose of fertility treatment and were in excess of the needs of the individuals seeking such treatment; (2) the embryos would never be implanted in a woman and would otherwise be discarded; and (3) such individuals donate the embryos with written informed consent and receive no financial or other inducements.

  • Directs the Secretary to: (1) issue final guidelines to carry out this Act within 60 days; and (2) submit annual reports on activities and research conducted under this Act.

  • (Sec. 3) Requires the Secretary to develop techniques for the isolation, derivation, production, or testing of stem cells that are capable of producing all or almost all of the cell types of the developing body and may result in improved understanding of treatments for diseases and other adverse health conditions, but that are not derived from a human embryo. Requires the Secretary to: (1) provide guidance concerning the next steps required for additional research; (2) prioritize research with the greatest potential for near-term clinical benefit; and (3) take into account techniques outlined by the President's Council on Bioethics and any other appropriate techniques and research.

  • Sets forth reporting requirements.

  • Authorizes appropriations. Passed Senate and House 6/7/2007

Stem cell legislation in 109th and 110th congress

  • HR810 Stem Cell Research Enhancement Act of 2005 passed 7/18/06 Bush vetoes 7/19/06

  • S5 Stem Cell Research Enhancement Act of 2007. Passed 6/7/2007. Bush vetoes 6/20/2007

  • 2/21/08 Sen. Clinton calls for an end to the President’s War on Science.

Votes on S5: Stem Cell Research Enhancement Act of 2007

NIH-funded scientists can only work on stem cell lines that were created prior to August of 2001. No new lines can be created from embryos.

Multiple attempts to overturn this prohibition (most recently S5) have passed House and Senate, only to be vetoed by the President.

NIH has been essentially flat-funded for the past 4 years while biomedical research costs have escalated at close to 4%/year. The President’s FY2009 budget calls for a further decrease in biomedical research funding.

Stem Cell Policy and the NIH

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