Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Opinion
  • Published:

A call for the creation of personalized medicine databases

Abstract

The success of the Human Genome Project raised expectations that the knowledge gained would lead to improved insight into human health and disease, identification of new drug targets and, eventually, a breakthrough in healthcare management. However, the realization of these expectations has been hampered by the lack of essential data on genotype–drug-response phenotype associations. We therefore propose a follow-up to the Human Genome Project: forming global consortia devoted to archiving and analysing group and individual patient data on associations between genotypes and drug-response phenotypes. Here, we discuss the rationale for such personalized medicine databases, and the key practical and ethical issues that need to be addressed in their establishment.

This is a preview of subscription content, access via your institution

Access options

Buy this article

Prices may be subject to local taxes which are calculated during checkout

Similar content being viewed by others

References

  1. Collins, F. S. et al. A vision for the future of genomics research. Nature 422, 835–847 (2003).

    Article  CAS  Google Scholar 

  2. Flordellis, C. S. The emergence of a new paradigm of pharmacogenomics. Pharmacogenomics 6, 515–526 (2005).

    Article  CAS  Google Scholar 

  3. Aharon-Peretz, J., Rosenbaum, H., Gershoni-Baruch, R. Mutations in the glucocerebrosidase gene and Parkinson's disease in Ashkenazi Jews. N. Engl. J. Med. 351, 1972–1977 (2004).

    Article  CAS  Google Scholar 

  4. Altman, R. B, Rubin, D. L. & Klein, T. E. An 'Omics' view of drug development. Drug Dev. Res. 62, 8185 (2004).

    Article  Google Scholar 

  5. Nebert, D. W. & Vesell, E. S. Advances in pharmacogenomics and individualized drug therapy: exciting challenges that lie ahead. Eur. J. Pharmacol. 500, 267–280 (2004).

    Article  CAS  Google Scholar 

  6. Frueh, F. W. & Gurwitz, D. From pharmacogenetics to personalized medicine: a vital need for educating health professionals and the community. Pharmacogenomics 5, 571–579 (2004).

    Article  Google Scholar 

  7. Gurwitz, D. & Weizman, A. Personalized psychiatry: a realistic goal. Pharmacogenomics 5, 213–217 (2004).

    Article  Google Scholar 

  8. Hewett, M. et al. PharmGKB: the Pharmacogenetics Knowledge Base. Nucleic Acids Res. 30, 163–165 (2002).

    Article  CAS  Google Scholar 

  9. Klein, T. E. & Altman, R. B. PharmGKB: the pharmacogenetics and pharmacogenomics knowledge base. Pharmacogenomics J. 4, 1 (2004).

    Article  CAS  Google Scholar 

  10. Ferrin et al. Enhancing data sharing in collaborative research projects with DASH. Pac. Symp. Biocomput. 260–271 (2005).

  11. Gibson, L. GlaxoSmithKline to publish clinical trials after US lawsuit. BMJ 328, 1513 (2004).

    PubMed  PubMed Central  Google Scholar 

  12. Knoppers, B. M. & Chadwick, R. Human genetic research: emerging trends in ethics. Nature Rev. Genet. 6, 75–79 (2005).

    Article  CAS  Google Scholar 

  13. Couzin, J. Drug safety. Withdrawal of Vioxx casts a shadow over COX-2 inhibitors. Science 306, 384–385 (2004).

    Article  CAS  Google Scholar 

  14. International Committee of Medical Journal Editors. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N. Engl. J. Med. 351, 1250–1251 (2004).

  15. Cambon-Thomsen, A., Sallee, C., Rial-Sebbag, E. & Knoppers, B. M. Population genetic databases: is a specific ethical and legal framework necessary? GenEdit 3 [on-line], <http://www.humgen.umontreal.ca/int/GE/en/2005-1.pdf> (2005).

  16. Breckenridge, A. et al. Pharmacogenetics: ethical problems and solutions. Nature Rev. Genet. 5, 676–680 (2004).

    Article  CAS  Google Scholar 

  17. Lunshof, J. E. Personalized medicine: how much can we afford? A bioethics perspective. Personalized Medicine 2, 43–47 (2005).

    Article  Google Scholar 

  18. Harris, J. & Sulston, J. Genetic equity. Nature Rev. Genet. 5, 796–800 (2004).

    Article  CAS  Google Scholar 

  19. Lesko, L. J. & Woodcock, J. Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective. Nature Rev. Drug Discov. 3, 763–769 (2004).

    Article  CAS  Google Scholar 

  20. Falit, B. The path to cheaper and safer drugs: revamping the pharmaceutical industry in light of GlaxosmithKline's settlement. J. Law Med. Ethics. 33, 174–179 (2005).

    PubMed  Google Scholar 

  21. Waller, P. C., Evans, S. J. & Beard, K. Drug safety and regulation. BMJ 331, 4–5 (2005).

    Article  Google Scholar 

  22. Gurwitz, D. Should Third-World countries pay the tab for new drug development? Acad Med. 74, 203 (1999).

    Article  CAS  Google Scholar 

  23. Resnik, D. B. Developing drugs for the developing world: an economic, legal, moral, and political dilemma. Developing World Bioeth. 1, 11–32 (2001).

    Article  CAS  Google Scholar 

  24. Institute of Medicine Report. To Err Is Human. Building a Safer Health System. (Committee on Quality of Health Care in America, Institute of Medicine) (eds Kohn, L., Corrigan, J. & Donaldson, M.) (National Academy, Washington DC, 1999).

  25. Ernst, F. R. & Grizzle, A. J. Drug-related morbidity and mortality: updating the cost-of-illness model. J. Am. Pharm. Assoc. (Wash). 41, 192–199 (2001).

    Article  CAS  Google Scholar 

  26. Dormann, H. et al. Readmissions and adverse drug reactions in internal medicine: the economic impact. J. Intern. Med. 255, 653–663 (2004).

    Article  CAS  Google Scholar 

  27. Pirmohamed, M. et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18,820 patients. BMJ 329, 15–19 (2004).

    Article  Google Scholar 

  28. Humphreys, B. L., Lindberg, D. A., Schoolman, H. M. & Barnett, G. O. The Unified Medical Language System: an informatics research collaboration. J. Am. Med. Inform. Assoc. 5, 1–11 (1998).

    Article  CAS  Google Scholar 

  29. Dolin, R. H. et al. HL7 Clinical Document Architecture, Release 2. J. Am. Med. Inform. Assoc. 2005 Oct 12 [epub ahead of print].

  30. Lussier, Y. A., Rothwell, D. J. & Cote, R. A. The SNOMED model: a knowledge source for the controlled terminology of the computerized patient record. Methods Inf. Med. 37, 161–164 (1998).

    Article  CAS  Google Scholar 

  31. McDonald, C. J. et al. LOINC, a universal standard for identifying laboratory observations: a 5-year update. Clin. Chem. 49, 624–633 (2003).

    Article  CAS  Google Scholar 

  32. Smith, C. L., Goldsmith, C. A. & Eppig, J. T. The Mammalian Phenotype Ontology as a tool for annotating, analyzing and comparing phenotypic information. Genome Biol. 6, R7 (2005).

    Article  Google Scholar 

  33. Altman, R. B. Building successful biological databases . Brief Bioinform. 5, 4–5 (2004).

    Article  Google Scholar 

  34. van Ommen, G. J. Genomics: the human genome, revisited. Eur. J. Hum. Genet. 13, 265–267 (2005).

    Article  CAS  Google Scholar 

Download references

Acknowledgements

The authors wish to thank anonymous referees for their insightful comments.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to David Gurwitz.

Ethics declarations

Competing interests

The authors declare no competing financial interests.

Related links

Related links

FURTHER INFORMATION

Human Genome Project

ClinicalTrials.gov

DrugInteractions.com

EMBRACE Network Of Excellence

European Commission Sixth Framework Decision: Integrating and Strengthening the European Research Area: Life Sciences, Genomics and Biotechnology for Health

GlaxoSmithKline Clinical Trial Register

Human Cytochrome P450 Allele Nomenclature Committee

Mouse Genome Informatics

NIH Pharmacogenetics Research Network

Organisation for Economic Co-operation and Development

P3G Observatory

PharmaGKB

The SNP Consortium

UCSF Pharmacogenetics of Membrane Transporters

Rights and permissions

Reprints and permissions

About this article

Cite this article

Gurwitz, D., Lunshof, J. & Altman, R. A call for the creation of personalized medicine databases. Nat Rev Drug Discov 5, 23–26 (2006). https://doi.org/10.1038/nrd1931

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/nrd1931

This article is cited by

Search

Quick links

Nature Briefing

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing