Addressing ethical challenges at the intersection of pharmacogenomics and primary care using deliberative consultations
Abstract
Aim: Primary care physicians will play a central role in the successful implementation of pharmacogenomics (PGx); however, important challenges remain. We explored the perspectives of stakeholders on key challenges of the PGx translation process in primary care using deliberative consultations. Methods: Primary care physicians, patients and policy-makers attended deliberations, where they discussed four ethical questions raised by PGx research and implementation in the primary care context. Results: Stakeholders voiced skepticism regarding PGx funding, commercialization, regulation, maintenance of an equal access healthcare system and restructuring of health research incentives and priorities in the public sector. Conclusion: Deliberants developed governing principles for a PGx-specific charter of ethics, aiming to protect the interests of patients, and outlined recommendations for the future of PGx in primary care.
Papers of special note have been highlighted as: •• of considerable interest
References
- 1 . Pharmacogenomics in clinical practice and drug development. Nat. Biotechnol. 30(11), 1117–1124 (2012).
- 2 . Theranostics in primary care: pharmacogenomics tests and beyond. Expert Rev. Mol. Diagn. 12(8), 841–855 (2012).
- 3 . Defining the opportunity for pharmacogenetic intervention in primary care. Pharmacogenomics 7(1), 61–65 (2006).
- 4 . Improving drug prescribing in primary care: a critical analysis of the experimental literature. Milbank Q. 83(4),
doi:10.1111/j.1468-0009.2005.00435.x (2005). - 5 . Determinants of the range of drugs prescribed in general practice: a cross-sectional analysis. BMC Health Serv. Res. 7(1), 132 (2007).
- 6 The future of genomic testing in primary care: the changing face of personalized medicine. Per. Med. 11(5), 477–486 (2014). •• This perspective article provides further details on the importance of primary care in the clinical application of personalized medicine and particularly pharmacogenomics.
- 7 . Economic evaluations of pharmacogenetic and genomic screening programs: update of the literature. Drug Dev. Res. 71(8), 492–501 (2010).
- 8 Adverse drug reaction risk factors in older outpatients. Am. J. Geriatr. Pharmacother. 1(2), 82–89 (2003).
- 9 . Biobanking in British Columbia: discussions of the future of personalized medicine through deliberative public engagement. Per. Med. 5(3), 285–296 (2008). •• This original research article demonstrates the use of public deliberation as an efficient method for policy input and decision-marking in the field of personalized medicine.
- 10 . Primary care physicians’ knowledge of and experience with pharmacogenetic testing. Clin. Genet. 82(4), 388–394 (2012).
- 11 . Science and society – research ethics and the challenge of whole-genome sequencing. Nat. Rev. Genetics 9(2), 152–156 (2008).
- 12 . Anticipating clinical integration of pharmacogenetic treatment strategies for addiction: are primary care physicians ready? Clin. Pharmacol. Ther. 83(4), 635–639 (2008).
- 13 . Genetics and primary care: where are we headed? J. Transl. Med. 12, 238 (2014).
- 14 . Deliberative democratic theory. Political Science 6, 307–326 (2003).
- 15 . Patient partnership in decision-making on biomedical research – changing the network. Sci. Technol. Hum. Val. 32(3), 339–368 (2007).
- 16 . The value and challenges of participatory research: strengthening its practice. Annu. Rev. Public Health 29, 325–350 (2008).
- 17 . Virtual special issue introduction: public participation in health policy in high income countries – a review of why, who, what, which, and where? Soc. Sci. Med. 71(9), 1537–1540 (2010).
- 18 . When the People Speak: Deliberative Democracy And Public Consultation. Oxford University Press, NY, USA (2009).
- 19 . Biobanking, public consultation, and the discursive logics of deliberation: five lessons from British Columbia. Public Underst. Sci. 19(4), 452–468 (2010).
- 20 . Foundations And Frontiers Of Deliberative Governance. Oxford University Press, NY, USA (2010).
- 21 . Discursive Democracy: Politics, Policy, And Political Science. Cambridge University Press, NY, USA (1990).
- 22 . Democracy And Disagreement. Belknap Press of Harvard University Press, MA, USA (1996).
- 23 . Assessing the quality of democratic deliberation: a case study of public deliberation on the ethics of surrogate consent for research. Soc. Sci. Med. 70(12), 1896–1903 (2010).
- 24 . A framework for assessing the quality of democratic deliberation: enhancing deliberation as a tool for bioethics. J. Empir Res. Hum. Res. Ethics 6(3), 3–17 (2011).
- 25 . Deliberations about deliberative methods: issues in the design and evaluation of public participation processes. Soc. Sci. Med. 57(2), 239–251 (2003).
- 26 . Implementing a public deliberative forum. Hastings Cent. Rep. 42(2), 20–23 (2012).
- 27 . Morality and ethical life – does Hegel critique of Kant apply to discourse ethics. Northwest U Law Rev. 83(1–2), 38–53 (1989).
- 28 . Synthesising the outputs of deliberation: extracting meaningful results from a public forum. J. Public Deliberation 9(1), 8 (2013).
- 29 . Broad versus blanket consent for research with human biological samples. Hastings Cent. Rep. 43(5), 3–4 (2012).
- 30 . Practice-based research – “Blue Highways” on the NIH roadmap. JAMA 297(4), 403–406 (2007).
- 31 . Diffusion theory and knowledge dissemination, utilization, and integration in public health. Annu. Rev. Public Health 30, 151–174 (2009).