Policy perspectives on the emerging pathways of personalized medicine

Dialogues in Clinical Neuroscience

Volumn 11, Issue 4, 2009, Pages 377-387

  Downing, Gregory J ^a  

^a U S DEPARTMENT OF HEALTH AND HUMAN SERVICES   (United States)

Author keywords

Clinical decision support; Coverage with evidence development; Genome wide association study; Health information technology; In vitro diagnostic multivariate index assay; Personalized medicine; Pharmacogenomics

Indexed keywords

CARBAMAZEPINE; CYTOCHROME P450 2C9; CYTOCHROME P450 2D6; FLUOXETINE; HLA B ANTIGEN; REDUCED NICOTINAMIDE ADENINE DINUCLEOTIDE (PHOSPHATE) DEHYDROGENASE (QUINONE); SEROTONIN UPTAKE INHIBITOR; TRASTUZUMAB; UNCLASSIFIED DRUG; VITAMIN K EPOXIDE REDUCTASE; WARFARIN;

BREAST CANCER; CIVIL RIGHTS; DATA BASE; DNA POLYMORPHISM; DRUG METABOLISM; GENE EXPRESSION PROFILING; GENE SEQUENCE; GENETIC ANALYSIS; GENETIC SCREENING; GENOMICS; HEALTH CARE DELIVERY; HEALTH CARE FINANCING; HEALTH CARE POLICY; HEALTH CARE PRACTICE; HEALTH CARE QUALITY; HEALTH CARE SYSTEM; HUMAN; HUMAN GENOME PROJECT; INDIVIDUALIZATION; INFORMATION PROCESSING; INFORMATION TECHNOLOGY; MEDICAL DECISION MAKING; MEDICAL PRACTICE; MOLECULAR BIOLOGY; PATIENT CARE; PATIENT PARTICIPATION; PERSONALIZED MEDICINE; PHARMACOGENOMICS; REIMBURSEMENT; REVIEW; STEVENS JOHNSON SYNDROME; UNITED STATES;

DECISION MAKING; DELIVERY OF HEALTH CARE; GENOME-WIDE ASSOCIATION STUDY; HEALTH POLICY; HUMANS; INDIVIDUALIZED MEDICINE; MEDICAL INFORMATICS; PATIENT PARTICIPATION; UNITED STATES;

EID: 75749140916     PISSN: 12948322     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (30)

1. Davis JC, Furstenthal L, Desai AA, et al. The microeconomics of personalized medicine: today's challenge and tomorrow's promise. Nat Rev: Drug Discovery. 2009;8:279-286.
2. Atkinson AJ, Colburn WA, DeGruttola VG, et al. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther. 2001;69:89-95.
3. U.S. Department of Health and Human Services, Washington D.C. Personalized health care: opportunities, pathways, resources, 2007. Available at: http://www.hhs.gov/myhealthcare/news/presonalized-health-care-9-2007.html. Accessed June 7, 2009.
4. U.S. Department of Health and Human Services, Washington D.C. Personalized health care: pioneers, partnerships, pathways. Available at: http://www/hhs/gov/myhealthcare/news/phc-2008-report.pdf. Accessed June 9, 2009.
5. Willard HW. Organization, variation and expression of the human genome as a foundation of genomic and personalized medicine. In: Willard HW, Ginsburg GS, eds. Genomic and Personalized Medicine. Volume 1. London, UK: Academic Press; 2009:4-21.
6. Foster MW, Mulvihill JJ, Sharp RR. Evaluating the utility of personal genomic information. Genet Med. 2009;11:575-576.
7. Christensen C, Grossman JH, Hwang J. The Innovator's Prescription: A Disruptive Solution for Health Care. New York, NY: McGraw-Hill; 2009.
8. Manolio TA, Brooks LD, Collins FS. A HapMap harvest of insights into the genetics of common disease. J Clin Invest. 2008;118:1590-1605.
9. Frueh FW, Amur S, Mummaneni P, et al. Pharmacogenomic biomarker information in drug labels approved by the United States food and drug administration: prevalence of related drug use. Pharmacotherapy. 2008;28:992-998.
10. U.S. Food and Drug Administration. Table of Valid Genomic Biomarkers in the Context of Approved Drug Labels. Available at: http://www.fda.gov/Drugs/ ScienceResearch/ResearchAreas/Pharmacogenetics/ucm083378.htm. Accessed June 17, 2009.
11. U.S. Food and Drug Administration. Voluntary Exploratory Data Submission (VXDS). Available at: http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/ Pharmacogenetics/ucm083673.htm. Accessed June 17, 2009.
12. de Leon J. Arranz MJ, Ruano G. Pharmacogenetic testing in psychiatry: a review of features and clinical realities. Clin Lab Med. 2008;28:599-617.
13. Jain KK. Applications of AmpliChip CYP450. Mol Diagn. 205;9:119-127.
14. Freeman JL, Perry GH, Feuk L, et al. Copy number variation: new insights in genome diversity. Genome Research. 2006;16:949-961.
15. McCarroll SA, Altshuler DM. Copy number variation and association studies of human disease. Nature Genetics. 2007;39:37-42.
16. Redon R, Ishikawa S, Fitch KR, et al. Global variation in copy number in the human genome. Nature. 2006;444:444-454.
17. Chen B, Gagnon M, Shahangian S, Anderson NL, Howerton DA, Boone JD. Good laboratory practices for molecular genetic testing for heritable diseases and conditions. Centers for Disease Control and Prevention (CDC). MMWR Recomm Rep. 2009;58(RR-6):1-37.
18. Ginsburg GS, Burke TW, Febbo P. Centralized biorepositories for genetic and genomic research. JAMA. 2008;299:1359-1361.
19. Mailman MD, Feolo M, Jin Y, et al. The NCBI dbGaP database of genotypes and phenotypes. Nature Genetics. 2007;39:1181-1186.
20. Psychiatric GWAS Consortium Coordinationg Committee. Genomewide association studies: history, rationale, and prospects for psychiatric disorders. Am J Psychiatry. 2009;166:540-556.
21. Blumenthal D. Stimulating the adoption of health information technology. N Engl J Med. 2009;360:1477-1479.
22. National Institutes of Health. Revised Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research. Available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html. Accessed June 18, 2009.
23. National Institutes of Health. Cancer Data Standards Registry and Repository (caDSR). Available at: http://ncicb.nci.nih.gov/NCICB/infrastructure/ cacore-overview/cadsr. Accessed June 19, 2009.
24. Genetic Information Nondiscrimination Act of 2008 (GINA), Pub. L. 110-233, 122 Stat. 881 (codified at 42 U.S.C. 2000ff et seq.)
25. U.S. System of Oversight of Genetic Tests: A Response to the Secretary of HHS. April 2008. Secretary's Advisory Committee on Genetics, Health and Society. Available at: http://oba.od.nih.gov/oba/SACGHS/reports/SACGHS- oversight-report.pdf. Accessed June 3, 2009.
26. Wald N, Cuckle H. Reporting the assessment of screening and diagnostic tests. Br J Obstet Gynaecol. 1989;96:389-396.
27. Haddow JE, Palomaki GE. ACCE: A model process for evaluating data on emerging genetic tests. In: Khoury M, Little J, Burke W, eds. Human Genome Epidemiology: A Scientific Foundation for Using Genetic Information to Improve Health and Prevent Disease. New York, NY: Oxford University Press; 2003:217-233.
28. Centers for Disease Control and Prevention. Evaluation of Genomic Applications in Practice and Prevention. Available at: http://www.cdc.gov/ genomics/gtesting/egapp/about.htm. Accessed June 17, 2009.
29. U.S. Agency for Healthcare Research and Quality. Testing for Cytochrome P450 Polymorphisms in Adults With Non-Psychotic Depression Treated With Selective Serotonin Reuptake Inhibitors (SSRIs). Structured Abstract. 2007. Available at: http://www.ahrq.gov/clinic/tp/cyp450tp.htm. Accessed June 17, 2009.
30. Khoury MJ, Berg A, Coates R, Evans J, Teutsch SM, Bradley LA. The evidence dilemma in genomic medicine. Health Affairs. 2008;27:1600-1611.