Skip to main content
Log in

The Personalized Medicine Coalition

Goals and Strategies

American Journal of Pharmacogenomics

Abstract

The concept of personalized medicine — that medical care can be tailored to the genomic and molecular profile of the individual — has repercussions that extend far beyond the technology that makes it possible. The adoption of personalized medicine will require changes in healthcare infrastructure, diagnostics and therapeutics business models, reimbursement policy from government and private payers, and a different approach to regulatory oversight. Personalized medicine will shift medical practices upstream from the reactive treatment of disease, to proactive healthcare management including screening, early treatment, and prevention, and will alter the roles of both physician and patient. It will create a greater reliance on electronic medical records and decision support systems in an industry that has a long history of resistance to information technology.

Personalized medicine requires a systems approach to implementation. But in a healthcare economy that is highly decentralized and market driven, it is incumbent upon the stakeholders themselves to advocate for a consistent set of policies and legislation that pave the way for the adoption of personalized medicine. To address this need, the Personalized Medicine Coalition (PMC) was formed as a nonprofit umbrella organization of pharmaceutical, biotechnology, diagnostic, and information technology companies, healthcare providers and payers, patient advocacy groups, industry policy organizations, major academic institutions, and government agencies. The PMC provides a structure for achieving consensus positions among these stakeholders on crucial public policy issues, a role which will be vital to translating personalized medicine into widespread clinical practice.

In this article, we outline the goals of the PMC, and the strategies it will take to foster communication, debate, and consensus on issues such as genetic discrimination, the reimbursement structures for pharmacogenomic drugs and diagnostics, regulation, physician training and medical school curricula, and public education.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Table I
Fig. 1
Fig. 2

Notes

  1. 1The structure for achieving a consensus begins with a draft statement introduced by PMC members or the executive director. The draft is presented to the Public Policy Committee, which reviews the statement and issues a document to the membership. The document would include context, background, pros and cons, and a recommended statement/position. Revisions may be made by the PMC membership or executive director, and sent back to the Public Policy Committee for endorsement by a two-thirds majority vote. Final approval is made by a two-thirds majority vote from the PMC Board of Directors.

References

  1. Stearns V, Davidson NE, Flockhart D. Pharmacogenetics in the treatment of breast cancer. Pharmacogenetics 2004; 4: 143–53

    CAS  Google Scholar 

  2. Marsh S, McLeod H. Cancer pharmacogenetics. Br J Cancer 2004; 90: 8–11

    Article  PubMed  CAS  Google Scholar 

  3. Webster A, Martin P, Lewis G, et al. Integrating pharmacogenetics into society: in search of a model. Nat Rev Genet 2004; 5: 663–9

    Article  PubMed  CAS  Google Scholar 

  4. Personalized Medicine Coalition: news and events [online]. Available from URL: http://www.personalizedmedicinecoalition.org/newsevents/news.php [Accessed 2005 Sep 1]

  5. Genomics and population health: United States, 2003. Atlanta (GA): Centers for Disease Control and Prevention, Office of Genomics and Disease Prevention, 2004 [online]. Available from URL: http://www.cdc.gov/genomics/activities/ogdp/2003.htm [Accessed 2005 Sep 1]

  6. Pharmacogenetics Research Network. Goals for the Pharmacogenetics Research Network [online]. Available from URL: http://www.nigms.nih.gov/Initiatives/PGRN/Background/Goals.htm [Accessed 2005 Sep 1]

  7. Guidance for industry: pharmacogenomic data submissions. Rockville (MD): US Department of Health and Human Services, US Food and Drug Administration, March 2005 [online]. Available from URL: http://www.fda.gov/cder/guidance/6400fnl.pdf [Accessed 2005 Sep 1]

  8. Our inheritance, our future: realising the potential of genetics. London: National Health Service, Department of Health, 2003 [online]. Available from URL: http://www.dh.gov.uk/assetRoot/04/01/92/39/04019239.pdf [Accessed 2005 Sep 1]

  9. Duke Institute for Genome Sciences and Policy [online]. Available from URL: http://www.genome.duke.edu [Accessed 2005 Sep 1]

  10. Genetics and Public Policy Center, Johns Hopkins University [online]. Available from URL: http://www.dnapolicy.org [Accessed 2005 Sep 1]

  11. Burton H. Addressing genetics, delivering health: a strategy for advancing the dissemination and application of genetics knowledge throughout our health professions. Cambridge: Public Health Genetics Unit, 2003 [online]. Available from URL: http://www.phgu.org.uk/resources/educ_project/addressing_genet-ics_full_300903.pdf [Accessed 2005 Sep 1]

    Google Scholar 

  12. Suther S, Goodson P. Barriers to the provision of genetic services by primary care physicians: a systematic review of the literature. Genet Med 2003; 5(2): 70–6

    Article  PubMed  Google Scholar 

  13. Wideroff L, Thomas VS, Greene MH, et al. A hereditary breast/ovarian and colorectal cancer genetics knowledge in a national sample of US physicians. J Med Genet. Epub 2005 Mar 22

  14. Elliott VS. Genetic testing issues land in primary care practices. Am Med News 2004 Nov 8 [online]. Available from URL: http://www.ama-assn.org/amednews/2004/11/08/hll11108.htm [Accessed 2005 Sep 1]

    Google Scholar 

  15. Pharmaceutical industry profile 2005. From laboratory to patient: pathways to biopharmaceutical innovation. Washington, DC: Pharmaceutical Research and Manufacturers of America, 2005 [online]. Available from URL: http://www.phrma.org/publications/publications//2005-03-17.1143.pdf [Accessed 2005 Sep 1]

  16. Gollust SE, Hull SC, Wilfond BS. Limitations of direct-to-consumer advertising for clinical genetic testing. JAMA 2002; 288(14): 1762–7

    Article  PubMed  Google Scholar 

  17. Physicians slow to adopt IT for patient care [editorial]. Drug Benefit Trends 2004; 16(11): 535

    Google Scholar 

  18. Koppel R, Metlay JP, Cohen A, et al. Role of computerized physician order entry systems in facilitating medication errors. JAMA 2005; 293: 1197–203

    Article  PubMed  CAS  Google Scholar 

  19. Javitt JC, Steinberg G, Locke T, et al. Using a claims data-based sentinel system to improve compliance with clinical guidelines: results of a randomized prospective study. Am J Manag Care 2005; 11(2): 93–102

    PubMed  Google Scholar 

  20. Bush pushes computerized medical records. Associated Press 2005 Jan 27 [online]. Available from URL: http://msnbc.msn.com/id/6876192/ [Accessed 2005 Sep 1]

  21. What do Newt Gingrich and Hillary Clinton agree on? Fed money for health IT. InformationWeek 2005 May 11 [online]. Available from URL: http://informationweek.com/story/showArticle.jhtml?articleID=163101097 [Accessed 2005 Sep 1]

  22. In unexpected Medicare benefit, U.S. will offer doctors free electronic records system. N Y Times 2005 Jul 21; Sect. A: 14 (col. 1)

  23. Schoonmaker MM, Bernhardt BA, Holtzman NA. Factors influencing health insurers’ decisions to cover new genetic technologies. Int J Technol Assess Health Care 2000; 16(1): 178–89

    Article  PubMed  CAS  Google Scholar 

  24. The Lewin Group. The value of diagnostics: innovation, adoption and diffusion into health care. 2005 Jul [online]. Available from URL: http://www.advamed.org/publicdocs/thevalueofdiagnostics.pdf [Accessed 2005 Sep 1]

  25. Drug-diagnostic co-development concept paper. Rockville (MD): US Department of Health and Human Services, Food and Drug Administration, 2005 Apr [online]. Available from URL: http://www.fda.gov/cder/genomics/pharmacoconceptfn.pdf [Accessed 2005 Sep 1]

  26. Lesko LJ, Woodcock J. Pharmcogenomic-guided drug development: regulatory perspective. Pharmacogenomics J 2002; 2: 20–4

    Article  PubMed  CAS  Google Scholar 

  27. Issa AM. Pharmacogenomic profiling in postmarketing surveillance: prospects and challenges. Pharmacogenomics 2003; 4(5): 647–55

    Article  PubMed  Google Scholar 

  28. Ratner ML. Pharmacogenomic data and labeling: a less-safe harbor for existing drugs? Windhover’s Update 2003 May 25 [online]. Available from URL: http://www.windhover.com/update/05252003/2003800094.htm [Accessed 2005 Sep 1]

  29. Feigal DW, Gutman S. Drug development, regulation, and genetically guided therapy. In: Rothstein MA, editor. Pharmacogenomics: social, ethical, and clinical dimensions. Hoboken (NJ): John Wiley & Sons, 2003: 99–108

    Google Scholar 

  30. Roses AD. Pharmacogenetics and future drug development and delivery. Lancet 2000; 355: 1358–61

    Article  PubMed  CAS  Google Scholar 

  31. Robertson JA, Brody B, Buchanan A, et al. Pharmacogenetic challenges for the health care system: genetically based drug prescribing could decrease overall health costs and fuel new drug development. Health Aff 2002; 21(4): 155–67

    Article  Google Scholar 

  32. Phillips KA, Veenstra DL, Sadee W. Implications of the genetics revolution for health services research: pharmacogenomics and improvements in drug therapy. Health Serv Res 2000; 35(5): 1–12

    Google Scholar 

  33. Phillips KA, Veenstra DL, Ramsey SD, et al. Genetic testing and pharmacogenomics: issues for determining the impact to healthcare delivery and costs. Am J Manag Care 2004; 10: 425–32

    PubMed  Google Scholar 

  34. Veenstra DL, Higashi MK, Phillips KA. Assessing the cost-effectiveness of pharmacogenomics. AAPS PharmSci 2000 Sep 14; 2(3): article 29 [online]. Available from URL: http://www.aapspharmsci.org/articles/ps0203/ps020329/ps020329.pdf [Accessed 2005 Sep 1]

    Article  Google Scholar 

  35. Nuffield Council on Bioethics. Pharmacogenetics: ethical issues. London: Nuffield Council on Bioethics, 2003 [online]. Available from URL: http://www.nuffieldbioethics.org/fileLibrary/pdf/pharmacogenetics_report.pdf [Accessed 2005 Sep 1]

    Google Scholar 

  36. Epps P. Policy before practice. Am J Pharmacogenomics 2003; 3(6): 405–18

    Article  PubMed  Google Scholar 

  37. Breckenridge A, Lindpaintner K, Lipton P. Pharmacogenetics: ethical problems and solutions. Nat Rev Genet 2004; 5: 676–80

    Article  PubMed  CAS  Google Scholar 

  38. Vaszar LT, Cho MK, Raffin TA. Privacy issues in personalized medicine. Pharmacogenomics 2003; 4(2): 107–12

    Article  PubMed  Google Scholar 

  39. Freund CL, Wilfond BS. Emerging ethical issues in pharmacogenomics: from research to clinical practice. Am J Pharmacogenomics 2002; 2(4): 273–81

    Article  PubMed  Google Scholar 

  40. Moldrup C. Ethical, social and legal implications of pharmacogenomics: a critical review. Community Genet 2001; 4(4): 204–14

    Article  PubMed  Google Scholar 

  41. Zick CD, Mathews CJ, Roberts JS, et al. Genetic testing for Alzheimer’s disease and its impact on insurance purchasing behavior. Health Aff 2005; 24(2): 483–90

    Article  Google Scholar 

  42. Hall MA, Rich SS. Laws restricting health insurers’ use of genetic information: impact on genetic discrimination. Am J Hum Genet 2000 Jan; 66(1): 293–307

    Article  PubMed  CAS  Google Scholar 

  43. America’s Health Insurance Plans. Use of genetic information [online]. Available from URL: http://www.ahip.org/content/default.aspx?.bc=39|341|326 [Accessed 2005 Sep 1]

  44. Collins FS, McKusick VA. Implications of the human genome project for medical science. JAMA 2001; 285(5): 540–4

    Article  PubMed  CAS  Google Scholar 

  45. Frueh FW, Gurwitz D. From pharmacogenetics to personalized medicine: a vital need for educating health professionals and the community. Pharmacogenomics 2004; 5(5): 571–9

    Article  PubMed  Google Scholar 

  46. Burton H, Shuttleworth A. Genetics education for pharmacists. Pharm J 2003; 270: 84–5

    Google Scholar 

  47. Centers for Disease Control and Prevention (CDC) awards funds for genetics programs [online]. Released 2001 Oct 18. Available from URL: http://www.cdc.gov/genomics/activities/fund2001.htm [Accessed 2005 Apr 30]

  48. Rothstein MA, Hornung CA. Public attitudes toward pharmacogenomics. In: Rothstein MA, editor. Pharmacogenomics: social, ethical, and clinical dimensions. Hoboken (NJ): John Wiley & Sons, 2003: 3–28

    Google Scholar 

  49. Wideroff L, Vadaparampil ST, Breen N, et al. Awareness of genetic testing for increased cancer risk in the year 2000 National Health Interview Survey. Community Genet 2003; 6(3): 147–56

    Article  PubMed  Google Scholar 

  50. Wideroff L, Freedman AN, Olson L, et al. Physician use of genetic testing for cancer susceptibility: results of a national survey. Cancer Epidemiol Biomarkers Prev 2003; 12: 295–303

    PubMed  Google Scholar 

Download references

Acknowledgments

We would like to thank Marcia Kean, Christine Mackenzie, and J. Brian Munroe for their keen insights and assistance in preparing the manuscript. We report no funding or other sources of support that would create a conflict of interest with the content of this review.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Edward Abrahams.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Abrahams, E., Ginsburg, G.S. & Silver, M. The Personalized Medicine Coalition. Am J Pharmacogenomics 5, 345–355 (2005). https://doi.org/10.2165/00129785-200505060-00002

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2165/00129785-200505060-00002

Keywords

Navigation