Measuring the value of pharmacogenomics (original) (raw)
Collins, F. S. Shattuck lecture — Medical and societal consequences of the human genome project. N. Engl. J. Med.341, 28–37 (1999). ArticleCAS Google Scholar
Collins, F. S. & McKusick, V. A. Implications of the human genome project for medical science. JAMA285, 540–544 (2001). ArticleCAS Google Scholar
Varmus, H. Getting ready for gene-based medicine. N. Engl. J. Med.347, 1526–1527 (2002). Article Google Scholar
Khoury, M. J., McCabe, L. L. & McCabe, E. R. Population screening in the age of genomic medicine. N. Engl. J. Med.348, 50–58 (2003). ArticleCAS Google Scholar
Phillips, K. A. & Van Bebber, S. L. Regulatory perspectives on pharmacogenomics: a review of the literature on key issues faced by the United States Food and Drug Administration. Med. Care Res. Rev. (in the press).
Phillips, K. A., Van Bebber, S. L., Veenstra, D. & Sakowski, J. The economics of pharmacogenomics. Curr. Pharmacogenomics1, 277–284 (2003). ArticleCAS Google Scholar
Phillips, K. A., Veenstra, D., Van Bebber, S. L. & Sakowski, J. An introduction to cost-effectiveness and cost–benefit analysis of pharmacogenomics. Pharmacogenomics4, 231–239 (2003). Provides an overview of methods for analysing the value of pharmacogenomics. Article Google Scholar
Phillips, K. A., Veenstra, D. L., Oren, E., Lee, J. K. & Sadee, W. Potential role of pharmacogenomics in reducing adverse drug reactions: a systematic review. JAMA286, 2270–2279 (2001). ArticleCAS Google Scholar
Phillips, K. A., Veenstra, D. L., Ramsey, S. D., Van Bebber, S. L. & Sakowski, J. Genetic testing and pharmacogenomics: issues for determining the impact to health care delivery and costs. Am. J. Manag. Care10, 425–432 (2004). PubMed Google Scholar
Danzon, P. & Towse, A. The economics of gene therapy and of pharmacogenetics. Value Health5, 5–13 (2002). Article Google Scholar
Robertson, J. A., Brody, B., Buchanan, A., Kahn, J. & McPherson, E. Pharmacogenetic challenges for the health care system. Health Affairs21, 155–167 (2002). Article Google Scholar
Roses, A. D. Pharmacogenetics and the practice of medicine. Nature405, 857–895 (2000). ArticleCAS Google Scholar
Ingelman-Sundberg, M. Pharmacogenetics: an opportunity for a safer and more efficient pharmacotherapy. J. Intern. Med.250, 186–200 (2001). ArticleCAS Google Scholar
Fishbain, D. A. et al. Genetic testing for enzymes of drug metabolism: does it have clinical utility for pain medicine at the present time? A structured review. Pain Medicine5, 81–93 (2004). Article Google Scholar
Shah, J. Economic and regulatory considerations in pharmacogenomics for drug licensing and healthcare. Nature Biotechnol.21, 747–753 (2003). ArticleCAS Google Scholar
Evans, W. & Relling, M. Pharmacogenomics: translating functional genomics into rational therapeutics. Science286, 487–491 (1999). ArticleCAS Google Scholar
Holtzman, N. & Marteau, T. Will genetics revolutionize medicine? N. Engl. J. Med.343, 141–144 (2000). ArticleCAS Google Scholar
Holtzman, N. A. & Marteau, T. M. Will genetics revolutionalize medicine? Author response. N. Engl. J. Med.343, 1498 (2000). Article Google Scholar
Lindpaintner, K. Pharmacogenetics and the future of medical practice. J. Mol. Med.81, 141–153 (2003). Article Google Scholar
Issa, A. M. Ethical perspectives on pharmacogenomic profiling in the drug development process. Nature Rev. Drug Discov.1, 300–308 (2002). ArticleCAS Google Scholar
Issa, A. M. Ethical considerations in clinical pharmacogenomics research. Trends Pharm. Sci.21, 247–249 (2000). ArticleCAS Google Scholar
Clayton, E. W. Ethical, legal, and social implications of genomic medicine. N. Engl. J. Med.349, 562–569 (2003). Article Google Scholar
Ries Merikangas, K. & Risch, N. Genomic priorities and public health. Science302, 599–601 (2004). Evaluates the population impact of genomics on complex diseases. Article Google Scholar
Haga, S. B. & Burke, W. Using pharmacogenetics to improve drug safety and efficacy. JAMA291, 2869–2871 (2004). Assesses need for evidence and incentives to move pharmacogenomics forward. ArticleCAS Google Scholar
Webster, A., Martin, P., Lewis, G. & Smart, A. Integrating pharmacogenetics into society: in search of a model. Nature Rev. Genet.5, 663–669 (2004). ArticleCAS Google Scholar
Lesko, L. J. & Woodcock, J. Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective. Nature Rev. Drug Discov.3, 763–769 (2004). ArticleCAS Google Scholar
Lesko, L. J. et al. Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: report of the first FDA-PWG-PhRMA-DruSafe Workshop. J. Clin. Pharmacol.43, 342–358 (2003). ArticleCAS Google Scholar
Salerno, R. A. & Lesko, L. J. Pharmacogenomics in drug development and regulatory decision-making: the Genomic Data Submission (GDS) proposal. Pharmacogenomics5, 25–30 (2004). Article Google Scholar
FDC Reports. FDA Pharmacogenomics Advisory Committee Will Oversee Data Submission. The Pink Sheet 22 March (2004).
US Department of Health and Human Services & Food and Drug Administration. Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products [online], <http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html> (2004).
Secretary's Advisory Committee on Genetics Health and Society. Second Meeting, October 22–23 (2003).
Kaiser, J. FDA puts the brakes on Roche's gene array Test. Science302, 1134 (2003). ArticleCAS Google Scholar
Steimer, W. & Potter, J. M. Pharmacogenetic screening and therapeutic drugs. Clin. Chim. Acta315, 137–155 (2002). ArticleCAS Google Scholar
Phillips, K. A., Veenstra, D. L. & Sadee, W. Implications of the genetics revolution for health services research: pharmacogenomics and improvements in drug therapy. Health Services Research35, 1–12 (2000). Google Scholar
Phillips, K. A. & Van Bebber, S. L. Cost-effectiveness of pharmacogenomic interventions: a systematic review of the literature. Pharmacogenomics5, 1139–1149 (2004). Provides a review of cost-effectiveness analyses to date. Article Google Scholar
Gold, M., Siegel, J., Russell, L. & Weinstein, M. Cost-Effectiveness in Health And Medicine (Oxford Univ. Press, New York, 1996). Google Scholar
Drummond, M. F. Cost-of-illness studies — a major headache. Pharmacoeconomics2, 1–4 (1992). ArticleCAS Google Scholar
Rice, D. P. Estimating the cost of illness. (Public Health Service publication, US Gov. Printing Office, 1966). Google Scholar
Rice, D. P. Cost of illness studies: what is good about them? Inj. Prev.6, 177–179 (2000). ArticleCAS Google Scholar
Varmus, H. Evaluating the burden of disease and spending the research dollars of the National Institutes of Health. N. Engl. J. Med.340, 1914–15 (1999). ArticleCAS Google Scholar
European Society of Human Genetics. Polymorphic sequence variants in medicine: technical, social, legal and ethical issues — pharmacogenomics as an example. Background document. (Draft Version as per June 10, 2004) [online], <http://www.eshg.org/ESHG-IPTSPGX.pdf> (2004).
Meyer, U. A. Pharmacogenetics — five decades of therapeutic lessons from genetic diversity. Nature Rev. Genet.5, 669–676 (2004). ArticleCAS Google Scholar
Klein, T. E. et al. Integrating genotype and phenotype information: an overview of the PharmGKB project. Pharmacogenomics J.1, 167–170 (2001). ArticleCAS Google Scholar
Ingelman-Sundberg, M. Human drug metabolising cytochrome P450 enzymes: properties and polymorphisms. Naunyn-Schmiedebergs Arch. Pharmacol.369, 89–104 (2003). Article Google Scholar
American Heart Association. Heart Disease and Stroke Statistics — 2004 Update [online](2003).
National Institute of Mental Health. NIH Publication No. 01-4584. The numbers count — mental disorders in America: a summary of statistics describing the prevalence of mental disorders in America [online], <http://www.nimh.nih.gov/publicat/numbers.cfm> (2001).
Gibbons, R. J. et al. ACC/AHA 2002 guideline update for the management of patients with chronic stable angina: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for the Management of Patients with Chronic Stable Angina) [online], <http://www.acc.org/clinical/guidelines/stable/stable.pdf> (2002).
American College of Cardiology & American Heart Association Inc. ACC/AHA/ESC Pocket Guidelines for the Management of Patients with Atrial Fibrillation [online](2002).
DuPont, R. L., Rice, D. P., Shiraki, S. & Rowland, C. Economic costs of obsessive–compulsive disorder. Cited in Anxiety Disorders: Obsessive–Compulsive Disorder (MDchoice.com) [online], <http://mdchoice.com/Pt/consumer/anxOCD.asp> (1996).
Chan, E., Zhan, C. & Homer, C. J. Health care use and costs for children with attention-deficit/hyperactivity disorder: national estimates from the medical expenditure panel survey. Arch. Pediatr. Adolesc. Med.156, 504–11 (2002). Article Google Scholar
Rice, D. P. The economic impact of schizophrenia. J. Clin. Psychiatry60 (Suppl. 1), 28–30 (1999). Google Scholar
Adams, P. F., Hendershot, G. E. & Marano, M. A. Current estimates from the National Health Interview Survey, 1996. National Center for Health Statistics. Vital Health Stat 10(200) [online], <http://www.cdc.gov/nchs/data/series/sr_10/10_200_1.pdf> (1999).
Fendrick, A. M., Monto, A. S., Nightengale, B. & Sarnes, M. The economic burden of non-influenza-related viral respiratory tract infection in the United States. Arch. Intern. Med.163, 487–494 (2003). Article Google Scholar
Stewart, W. F., Ricci, J. A., Chee, E., Morganstein, D. & Lipton, R. Lost productive time and cost due to common pain conditions in the US workforce. JAMA290, 2443–2454 (2003). ArticleCAS Google Scholar
Lethbridge-Çejku, M., Schiller, J. S. & Bernadel, L. Summary health statisticsfor US Adults: National Health Interview Survey, 2002. National Center for Health Statistics. Vital and Health Statistics Series 10 [online], <http://www.cdc.gov/nchs/data/series/sr_10/sr10_222.pdf> (2004).
Pirmohamed, M. et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18,820 patients. BMJ329, 15–19 (2004). Article Google Scholar
Gasche, Y. et al. Codeine intoxication associated with ultrarapid CYP2D6 metabolism. N. Engl. J. Med.351, 2827–2831 (2004). ArticleCAS Google Scholar
Higashi, M. K. & Veenstra, D. L. Managed care in the genomics era: assessing the cost-effectiveness of genetic tests. Am. J. Manage Care9, 493–500 (2003). Google Scholar
Ingelman-Sundberg, M. Pharmacogenetics of cytochrome P450 and its applications in drug therapy: the past, present and future. Trends Pharmacol. Sci.25, 193–200 (2004). ArticleCAS Google Scholar
Collins, F. S., Green, E. D., Guttmacher, A. E. & Guyer, M. S. A vision for the future of genomics research. Nature422, 835–847 (2003). ArticleCAS Google Scholar
Evans, W. E. & Relling, M. K. Moving towards individualized medicine with pharmacogenomics. Nature429, 464–468 (2004). ArticleCAS Google Scholar
Zineh, I. et al. Availability of pharmacogenomics-based prescribing information in currently approved drugs. Pharmacogenomics J.4, 354–8 (2004). ArticleCAS Google Scholar
Kirchheiner, J. et al. Pharmacogenetics of antidepressants and antipsychotics: the contribution of allelic variations to the phenotype of drug response. Mol. Psychol.9, 442–73 (2004). ArticleCAS Google Scholar
Klein, T. E. & Altman, R. B. PharmGKB: the pharmacogenetics and pharmacogenomics knowledge base. Pharmacogenomics J.4, 1 (2004). ArticleCAS Google Scholar
Drug Information Association. Co–Development of Drug, Biological, and Device Products (meeting announcement) [online], <http://www.diahome.org>(2004).
Feigal, D. W. & Gutman, S. in Pharmacogenomics: Social, Ethical, and Clinical Dimensions (ed. Rothstein, M. A.) 99–108 (John Wiley & Sons, Inc, New Jersey, 2003). Book Google Scholar