Academic journal article Rutgers Computer & Technology Law Journal

Personalized Genomics: A Need for a Fiduciary Duty Remains

Academic journal article Rutgers Computer & Technology Law Journal

Personalized Genomics: A Need for a Fiduciary Duty Remains

Article excerpt


A. Introduction to Personalized Genomics / Pharmacogenomics

Following the completion of the Human Genome Project (1) ("HGP"), genomics has come to the forefront of biomedical research. (2) Genomics refers to the study of genomes and individual DNA gene sequences. (3) Genomic scientists utilize an organism's genomic information to develop new research technologies and correspondingly use the research information to improve disease treatments. (4) Genomic research technologies include gene expression microarrays, (5) comparative genome hybridization, (6) and single nucleotide polymorphism ("SNP") databases. (7)

Since the HGP was only comprised of a few DNA donors' genomes, (8) researchers are currently undertaking efforts to sequence the genomes of many more individuals. (9) One such effort is the Personal Genome Project, initiated by Dr. George Church at Harvard University, who seeks volunteers to donate their DNA to be sequenced and later stored in public databases for biomedical research. (10) Church has stated that "[p]ersonal genomic research may be the key that unlocks preventative and therapeutic solutions for such life-threatening conditions as cancer, Alzheimer's disease, and heart disease...." (11)

In addition to public efforts like the Personal Genome Project, private personal genome sequencing companies have sprouted up. Knome, Inc., founded in 2007, provides full genome sequencing to its customers. (12) Other personal genomic companies include: 23andMe, (13) Illumina, (14) Navigenics, (15) deCODE Genetics, (16) and DNA Direct. (17) Such private companies sequence individuals' personal genomes for a fee, giving customers access to their genomic data. Over time, prices for personal genome sequencing have continued to decline. (18)

Pharmaceutical companies are also becoming increasingly involved in personalized genomics. Although large pharmaceutical companies do not offer personal genome services to customers, many drug companies now are involved in pharmacogenomic studies. (19) Pharmacogenomics is the study of how particular genomes and/or gene variants affect individuals' responses to particular drugs. (20) For instance, "[g]enetic variants in drug metabolizing enzymes can have a significant effect on the way a person responds to a drug." (21) Pharmacogenomics allows physicians to treat particular individuals with specific drugs exhibiting increased efficacy due to the patient's genetic profile. (22) Also noteworthy is that such pharmocogenomic studies have not only been the focus of independent research centers and private companies, but also of the Food and Drug Administration ("FDA") (23), the National Institutes of Health ("NIH") (24), and even the Secretary of Health and Human Services. (25)

B. Public Personalized Genomic Research

After receiving new funds through the American Recovery & Reinvestment Act of 2009, the NIH allocated $200 million for the 2009-10 fiscal years toward a new initiative called the "NIH Challenge Grants in Health and Science Research." (26) Many of the Challenge Areas and Challenge Topics identified by the NIH involve personalized genomic research, including not only how to effectively use such data, but also bioethical concerns over personal genomic databases and personal privacy. (27) In addition, the National Human Genome Research Institute ("NHGRI") at NIH recently committed $9.5 million toward genomic sequencing innovation, continuing the institute's drive to create a $1000 genome (hereinafter, 1000 Genomes Project). (28) The ability to sequence an individual's genome for $1000 would be a significant development in personalized medicine, especially considering the initial cost of the HGP. (29) Also, the Center for Disease Control ("CDC") and NIH co-hosted a workshop in 2008 which focused not only on the promise of personalized genomics, but also on the foundational scientific need to transform personalized genomics from mere laboratory research to everyday medical practice. …

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