Academic journal article
By Hicks, Kristin M.
Harvard Journal of Law & Technology , Vol. 21, No. 2
I. INTRODUCTION. II. THE ARGUMENT FOR MEDICAL SELF-DEFENSE IN THE STEM CELL CONTEXT A. The Theory of Medical Self-Defense B. Application of Medical Self-Defense to Stem Cell Treatments and Stem Cell Research 1. The Imminence Requirement 2. Injury to the Embryo 3. Protection for Stem Cell Research III. THE FUNDAMENTAL RIGHTS ANALYSIS A. Weaknesses of the Medical Self-Defense Theory B. The Medical Self-Defense Right May Be Unique to Abortion C. Framing the Right of Access to Stem Cell Therapies as Medical Self-Defense IV. CONCLUSION
Human embryonic stem cell research has been heralded as a miraculous discovery that will one day help cure some of humanity's most devastating illnesses, such as Huntington's disease and Parkinson's disease. (1) Though still in its early stages, (2) stem cell research holds the potential to help scientists understand the mechanisms of cell development and to provide effective models for developing new drugs and testing them for safety and efficacy. (3) Furthermore, because stem cells can develop into many different types of cells, further research may enable the generation of organs and tissue for transplantation. (4)
Despite the promise of stem cell research, it has nevertheless been the subject of considerable controversy since the technology was first developed. Much of this controversy has centered on the moral status of human embryos. Currently, researchers create stem cell lines by extracting cells from a pre-implantation embryo approximately five days after fertilization. (5) This process destroys the embryo. (6) Some people believe an embryo has the moral status of a person and consequently view stem cell research as killing human beings. (7) As a result of strongly held views on both sides of this debate, supporters and opponents of stem cell research in Congress have reached an impasse; although President Bush has announced that federal funds may only be used for research on a limited number of stem cell lines, (8) currently no federal law supports or bans embryonic stem cell research. (9)
State legislatures have filled the void left by the lack of federal regulation concerning stem cell research. The resulting state laws vary widely. Some states authorize or fund stem cell research, (10) while others ban research on embryonic stem cells from some or all sources, including existing stem cell lines, aborted or miscarried embryos, embryos created for in-vitro fertilization, and cloned embryos. (11) Many of the restrictions focus on therapeutic cloning, (12) one of the most promising methods of creating stem cell lines for research. (13) The restrictions appear to be motivated in part by an apparent fear that engaging in this process will lead scientists down a slippery slope towards reproductive cloning. (14) Currently, at least five states prohibit therapeutic cloning. (15) Furthermore, the Food and Drug Administration ("FDA") has claimed authority to regulate cloning as an investigational new drug ("IND"). (16) Research sponsors are required to submit an IND application to FDA that describes the proposed cloning research, and FDA has stated that it will not approve any human cloning IND applications until an IND appropriately addresses the safety concerns related to the use of cloning technology. (17)
Recent attacks on regulations limiting access to experimental drugs have cast doubt on the legitimacy of stem cell research restrictions. Notably, the Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation ("Abigail Alliance") recently brought suit against FDA, claiming that agency regulations denying access to drugs that had successfully completed Phase I clinical trials violated the constitutional rights of terminally ill patients. (18) Abigail Alliance argued that for patients who have life-threatening conditions and no other treatment options, restrictions on pre-approval drugs amount to a death sentence, which violates the Fifth Amendment protection against deprivation of life without due process. …