Genetic research: Are more limitations needed in the field?

• Author: Sosnowski, Kristie

1. INTRODUCTION

   Each year scientists uncover new mysteries, make miraculous discoveries, and perfect processes that will aid them in curing thousands of debilitating and fatal diseases. In the past century, several of the most fascinating discoveries were made in the field of genetic research. For instance, in 1997, scientists cloned a sheep. The infamous cloned sheep became known as Dolly.

   The importance of genetic research today is overwhelming. Although genetic research presents many legal and ethical concerns, the benefits drastically outweigh the costs. For instance over 140 million people stand to benefit from human embryonic stem cell research, including those Americans suffering from Parkinson's and Alzheimer's disease. (1)

   In an attempt to quell the legal and ethical concerns associated with genetic research, legislation has been developed and several administrative committees have been formed. The present restraints placed on the field of genetic research by the Legislature and the administrative committees are sufficient to deal with the legal and ethical issues raised.

   This Note will focus on the medical achievements that have been made, in large part, because of advances in genetic research. Specifically, this Note will focus on the genetic advances associated with the Human Genome Project, Gene Therapy, Genetic Testing, and Human Embryonic Stem Cell Research.

   The last year of the twentieth century brought scientists one step closer to the successful completion of the Human Genome Project. (2) The Human Genome Project is a government-funded project with the underlying goal of sequencing and mapping the entire human genome. (3) Scientists believe that the completion of this project will aid them in answering many questions associated with diseases currently afflicting thousands of Americans. (4)

   Additionally, researchers have made significant advances in the science of gene therapy. Researchers have developed a method referred to as gene replacement therapy. Through the use of gene replacement therapy researchers will be able to replace incorrect genetic material contained in a cell with the correct genetic material. (5) In addition to gene replacement therapy, scientists have also discovered a method of gene therapy that instructs a cell to internally correct a genetic mistake. (6)

   Genetic testing is another area in which scientists have made important advances. One advance is the availability of genetic testing for familial polyposis and non hereditary ployposis colon cancer. (7) Genetic testing is extremely important, because research has proven that early disease detection can drastically improve the quality and longevity of life. (8)

   In November 1998, scientists isolated stem cells in early human embryos. (9) Researchers feel this discovery will lead them to possible therapies for diseases such as Parkinson's and Alzheimer's. (10) Furthermore, scientists feel that they will be able generate human organs from isolated stem cells. (11) This development will enhance the therapeutic advantages of transplantation science. Those individuals drastically in need of organ transplants will no longer have to wait for an organ. With the ability to generate organs, doctors can help more patients, and significantly reduce the number of deaths associated with the unavailability of organs for use in transplantation surgeries.

   In addition to discussing the benefits of genetic research, this Note will outline some of the ethical and legal concerns associated with the field of genetic research. The most prevalent concerns associated with advances in genetic research center around the availability of genetic information and how this information will effect privacy rights and employment and insurance practices. There are several other concerns and many other benefits associated with genetic research; however, this Note does not encompass them. The availability of genetic information has caused people to become concerned about their privacy. (12) Additionally, individuals are concerned about how genetic information will be used by insurance providers in determining insurance coverage. (13) Similarly, the use of genetic information in employment practices presents another concern associated with the availability of genetic information. (14)

   There are special concerns associated with human embryonic stem cell research. Stem cells are isolated from human embryos. (15) Therefore, a major controversy associated with human embryonic stem cell research is the destruction of potential human life. (16) A secondary concern is that human embryonic stem cell research will encourage women to have abortions. (17) This Note will demonstrate how both of these concerns are unwarranted.

   Even though there are some ethical and legal issues associated with genetic research, further restrictions should not be placed on the field. This Note will discuss how the present limitations placed on the field of genetic research, by the Legislature and administrative committees, are sufficient to effectively suppress the aforementioned ethical and legal concerns.

   The Genetic Privacy Act and the Genetic Privacy and Non-Discrimination Act have been developed to address the issues previously raised. (18) The Americans with Disabilities Act is broad enough to cover concerns about the use of genetic information in employment practices. (19) The Health Insurance Portability and Accountability Act of 1996 addresses problems associated with the use of genetic information by insurance providers. (20)

   Additionally, several committees have been developed to specifically address the issues raised by genetic research. For example, the National Institute of Health and the Department of Energy developed the formal Ethical, Legal and Social Issues [hereinafter "ELSI"] programs. (21) These administrative committees are responsible for making policy recommendations to federal and state legislatures. (22)

   The benefits of genetic research clearly outweigh the costs. The present limitations placed on the field, by the Legislature and administrative committees, are sufficient to effectively quash the concerns.

2. SCIENTIFIC BACKGROUND

   The study of genetics dates back to the discovery of the human chromosome in 1870. (23) Following this important discovery, scientists determined that most human traits were heritable. (24) By the early twentieth century, Gregor Mendel developed his law of inheritance. (25) This law of inheritance became known as Mendelian inheritance. (26) With the development of Mendelian inheritance, the term "gene" was used to define the fundamental unit of heredity. (27)

   Expanding on Mendelian inheritance, Oswald Avery discovered that deoxyribonucleic acid or DNA is the chemical basis for inheritance. (28) The unveiling of DNA as the chemical basis for inheritance encouraged scientists to ascertain the structure of this molecule. James Watson and Francis Crick eventually unearthed the structure of DNA. (29) Watson and Crick determined that the structure of this molecule represented a winding ladder. (30) Therefore, the structure of DNA became known as a "double helix." (31)

   Each prong of the winding ladder represents a gene and is composed of nucleotides. (32) There are four nucleotides that make up a DNA sequence. (33) adenine, guanine, cytosine, and thymine. (34) The nucleotides are held together by weak bonds, and once bonded they become known as base pairs. (35) Base pairs consist of adeninethymine bonds and guanine-cytosine bonds. (36) The organization of these base pairs delineates the type of information a gene or piece of DNA will carry. (37)

   Once scientists codified DNA as the chemical basis for inheritance and determined that genes are the fundamental unit of heredity, the term "genome" was coined to refer to the total amount of genes and DNA found within an organism. (38) Scientists have yet to determine exactly how many genes are in the human genome; however, researchers estimate the number to be between 75,000 and 100,000. (39)

   After scientists came to understand the process of heredity, they moved on to more fascinating topics. Researchers began to ascertain why disease affects certain individuals and not others. Additionally, research established that all genetic disorders and many other diseases result from a mutation or change within the DNA sequence of a genome. (40) This change or mutation can be dramatic or slight. (41) Genes are comprised of base pairs, and scientists estimate that there are approximately three billion base pairs in the human genome. (42) Consequently, there are about three billion genetic loci that can be mutated. (43) Because researchers have concluded mutations are the root of many debilitating and fatal disorders, one can see the vast importance of enhanced genetic research.

3. BENEFITS OF GENETIC RESEARCH

   1. The Human Genome Project

      Every individual carries at least twenty harmful genes. (44) Until recent developments in genetics, physicians have been unable to identify these harmful genes. (45) Recognizing this immense problem, Congress developed the Human Genome Project. The Human Genome Project is federally funded and operated jointly by the National Institutes of Health and the Department of Energy. (46) Because of the medical and scientific importance of this project, Congress apportioned approximately $3 billion, or about $200 million per year for fifteen years to aid in its completion. (47)

      The ultimate goal of the Human Genome Project is to sequence, map, and decode the entire human genome. Researchers are striving to reach this goal by creating comprehensive linkage maps, disease maps, gene maps, physical maps, radiation hybrid maps, and body maps. (48) Scientists believe that these maps will prove to be extremely useful in disease gene discovery. (49) Researchers explain that one can look at a genetic map to determine if other investigators have independently placed a disease gene in...