Embryonic stem cells: marrow of the Dickey matter.

• Author: McGuire, Shannon

Cite as 11 J. High Tech. L. 160 (2010)

1. Introduction

   In the United States there are currently over 100,000 people waiting for organ transplants, with only a fraction of those individuals actually receiving them. (1) Recent data shows there were only 14,140 transplants performed between January and June of 2010 and of those transplants only 7,136 recovered. (2) The low recovery rate is caused by immune responses in the recipient triggered by foreign cells and tissue which can lead to a rejection of the transplant tissue or organ. (3) One promising solution for meeting the demand of transplants is stem cell-based therapies, which could provide doctors with a renewable source of healthy cells and tissues to repair failing organs. (4) Not only could stem cell-based transplants meet the high demand of organ transplants, but the rate of transplant rejection could be decreased as well by reducing the recipient's immune response. (5)

   The therapeutic potential of human embryonic stem cells (hESCs) is one of the many reasons why researchers are so motivated to work with various stem cell lines. (6) Unfortunately, with the controversy surrounding the destruction of the fetus for stem cells and the current restrictions on research involving embryos, there are limited stem cell lines available for testing. (7) The budget bill that funds the National Institute of Health (NIH) contains the restrictive language of the Dickey Amendment, prohibiting the use of federal funds for any research that subjects a human embryo to risk of injury or death. (8) The need to revise U.S. law, specifically the Dickey Amendment, is supported by existing data concerning stem cells, the therapeutic potential of cell-based therapies, and the success of Great Britain's administrative program, the Human Fertilisation and Embryology Authority (HFEA). (9)

   This Note discusses the issues surrounding the United States' current research policy involving human embryos and the ensuing negative impact on stem cell research. The main thesis explores the differences between the United States and foreign legal policies concerning research on human embryos, analyzing how the variations affect the economic and scientific potential of stem cell therapies. It presents alternative legal guidelines that permit the use of embryos under specific circumstances, while accounting for the delicate ethical and moral issues involved with human embryonic stem cell research. Following these proposals is a discussion about the advantages of an administrative program similar to the HFEA, and the benefits of having this type of framework.

2. History

   Embryonic stem cell research is one of many controversial issues currently dividing the United States. (10) One contention is that this type of science threatens the sanctity of human life by seeking to destroy the precious foundation of that life. (11) Another argument holds this area of research has seemingly limitless therapeutic potential and the ability to provide many people who are suffering with a better quality of life. (12) Because of the important ethical and traditional moral issues at stake, this topic has sparked a major political debate resulting in legal constraints that will have unfortunate economic and scientific consequences if not carefully analyzed. (13)

   1. Stem Cell Research

      In 1998, Dr. James Thomson from the University of Wisconsin first described the successful isolation of pluripotent stem cells from human embryos, launching the idea of stem cell research into the forefront of the scientific community. (14) Pluripotent stem cells are undifferentiated body cells, meaning they are without a characteristic structure or function and can differentiate into any type of cell. (15) This characteristic makes stem cells a valuable research tool; the therapeutic value lies in the cells' "degree of developmental plasticity," which varies depending on the type of stem cell. (16) Pluripotent embryonic stem cells have the ability to differentiate into all cell types. (17) In contrast, there are multipotent adult stem cells which are limited to the types of cells they can differentiate into. (18) Adult stem cells may be removed by a simple biopsy, so while their use is not legally or ethically controversial, research potential is limited and exhaustive. (19)

      Despite the vast medical possibilities, there are substantial moral, political, and legal obstacles that threaten to impede the advancement of this research. (20) The therapeutic potential of embryonic stem cells is extensive, including cures for heart failure, Alzheimer's disease, and spinal-cord injuries. (21) Moreover, pluripotent embryonic stem cells are economically valuable, offering the potential to generate billions of dollars in revenue for the United States by 20 1 8. (22) In spite of the therapeutic and economic benefits, embryonic stem cell utility is tempered by the fact that destruction of the embryo is required during the stem cell production process. (23)

      An alternative to embryonic stem cells is induced pluripotent stem (iPS) cells, which are adult skin cells that have been reprogrammed genetically to behave like embryonic stem cells. (24) However the disadvantage of using iPS cells is that clinical application is not yet an option for humans because the use of retrovirus vectors to modify the cells creates a risk of cancer development. (25) A recent study using mice was conducted to create iPS cells without the use of retroviruses, but the use of this technique on human iPS cells is still being tested. (26)

   2. U.S. Stem Cell Law

      In response to Roe v Wade, (27) members of Congress addressed concerns of exploiting aborted embryos and fetuses by placing a temporary suspension on federal funding of research that involved the destruction of human fetuses in 1974. (28) There was a political shift with regard to embryonic research in 1993 when a Democratic-controlled Congress was accompanied by Democratic President Bill Clinton. (29) President Clinton supported the NIH's use of federal research funds for embryos left over from in vitro-fertilization procedures. (30) Before a proposal could be approved, Congressional power swung back to the Republicans. (31) As a result, the Dickey Amendment was included in the budget bill which laid out certain restrictions on the type of embryonic research and cell lines that may be created for research purposes. (32) The Dickey Amendment was authored by Representative Jay Dickey, and is a provision to the NIH budget bill that is still in effect today. (33)

      Although many lawsuits were filed seeking answers to questions involving the rights of human embryos with regards to due process and equal protection, they were dismissed as moot for procedural problems once President Bush took office. (34) Thus, the federal questions regarding an embryo's right to due process and equal protection have yet to be answered by the federal courts. (35) In 2001, the Bush Administration instituted a ban on federal funding for embryonic stem cell research that created a scientific and political uproar. (36) This policy limited federal funding to about sixty stem cell lines that had been created prior to August 9, 2001. (37) These federal restrictions led to certain state initiatives, such as the California Stem Cell Research and Cures Initiative (Proposition 71). (38) The California proposition established stem cell research as a state constitutional right, granting $3 billion to research funding over the next ten years. (39) Further, Proposition 71 specifically made embryonic stem cell research the top priority of the state funds. (40) While the states have the authority to pass their own laws that permit embryonic stem cell research with state funds, the importance of federal funding was greatly stressed by scientists. (41)

      In 2009 President Obama lifted the Bush Administration's ban on embryonic stem cell research. (42) The scientific victory was short lived when days later President Obama signed an annual appropriations bill, which included the Dickey Amendment and its restriction on the cell lines used for stem cell research. (43) Despite these legal restrictions, President Obama directed the NIH to issue new stem cell research guidelines which allowed funding of research involving human embryos "that were created using in vitro fertilization for reproductive purposes and were no longer needed for this purpose," and "were donated by individuals who sought reproductive treatment ... and who gave voluntary written consent." (44)

      The revised guidelines were soon challenged in court as being contrary to the Dickey Amendment. (45) After hearing the plaintiffs' arguments against the guidelines, Chief Judge Lamberth of the District Court for the District of Columbia issued an injunction barring federal funding for embryonic stem cell research. (46) While the Department of Justice successfully requested the U.S. Circuit Court of Appeals to stay the injunction while the court reviews the case, research projects will be threatened if the Appeals Court affirms the lower court's ruling. (47) Despite the recent executive grant of federal funding for research, the Dickey Amendment proves to be an obstacle that scientists must maneuver around while seeking to advance the therapeutic potential of stem cells. (48)

   3. Foreign Embryonic Stem Cell Law

      As the United States hesitates to support this advancement in science, other countries with greater research options are threatening to surpass the developments of U.S. researchers. (49) The United Kingdom created the Human Fertilisation and Embryology Authority (HFEA) after passing the 1990 Human Fertilisation and Embryology Act. (50) The statutory functions of the HFEA include supervision of in vitro fertilization clinics, monitoring research facilities involved with human embryos, regulating storage of sperm, eggs, and embryos, and maintaining research licenses held by clinics. (51) The role of...