438
Views
0
CrossRef citations to date
0
Altmetric
Review

Beyond the Clinic: ‘Direct-to-Consumer‘ Genomic Profiling Services and Pharmacogenomics

&
Pages 403-412 | Published online: 25 Feb 2013

References

  • Topol E . The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care. Basic Books, NY, USA (2012).
  • Wright C , MacArthurDG. Direct to consumer genetic testing. In: Molecular Genetics and Personalized Medicine – Molecular and Translational Medicine. Best DH, Swensen JJ (Eds). Springer, NY, USA (2012).
  • Imai K , KrickaLJ, FortinaP. Concordance study of 3 direct-to-consumer genetic-testing services. Clin. Chem.57 , 518–521 (2011).
  • Zehnbauer B . Direct-to-consumer genetics testing – fair comparisons? Clin. Chem.57 , 369–371 (2011).
  • Eriksson N , MacphersonJM, TungJY et al. Web-based, participant-driven studies yield novel genetic associations for common traits. PLoS Genet. 6 , e1000993 (2010).
  • Do CB , TungJY, DorfmanE et al. Web-based genome-wide association study identifies two novel loci and a substantial genetic component for Parkinson‘s disease. PLoS Genet. 7(6) , e1002141 (2011).
  • Tung JY , DoCB, HindsDA et al. Efficient replication of over 180 genetic associations with self-reported medical data. PLoS ONE 6(8) , e23473 (2011).
  • Howard HC , BorryP. Direct-to-consumer genetic testing: More questions than benefits? Per. Med.5(4) , 317–320 (2008).
  • Feero WG , GuttmacherAE, CollinsFS. The genome gets personal – almost. JAMA299 , 1351–1352 (2008).
  • Hunter DJ , KhouryMJ, DrazenJM. Letting the genome out of the bottle – will we get our wish? N. Engl. J. Med.358(2) , 105–107 (2008).
  • Kraft P , HunterDJ. Genetic risk prediction – are we there yet? N. Engl. J. Med.360(17) , 1701–1703 (2009).
  • Caulfield T , McGuireAL. Direct-to-consumer genetic testing: perceptions, problems, and policy responses. Annu. Rev. Med.63 , 23–33 (2012).
  • Khoury MJ , BergA, CoatesR et al. The evidence dilemma in genomic medicine. Health Aff. (Millwood) 27(6) , 1600–1611 (2009).
  • Caulfield T . Direct-to-consumer genetics and health policy? A worst-case scenario? Am. J. Bioeth.9(6) , 48–50 (2009).
  • James KM , CowlCT, TilburtJC et al. Impact of direct-to-consumer predictive genomic testing on risk perception and worry among patients receiving routine care in a preventive health clinic. Mayo Clin. Proc. 86(10) , 933–940 (2011).
  • Nordgren A . Neither as harmful as feared by critics nor as empowering as promised by providers: risk information offered direct to consumer by personal genomics companies. J. Community Genet. doi:10.1007/s12687–012–0094–0090) (2012) (Epub ahead of print).
  • Howard H , BorryP. Direct-to-consumer pharmacogenomic testing. Pharmacogenomics12(10) , 1367–1370 (2011).
  • Leighton JW . The general public‘s understanding and perception of DTC genetic test results. Public Health Genomics15 , 11–21 (2012).
  • Vayena E , MauchF.Personal genomics: are we debating the right issues? Praxis (Bern 1994)101(15) , 961–964 (2012).
  • Hudson K , JavittG, BurkeW, Byers P; ASHG Social Issues Committee. ASHG statement* on direct-to-consumer genetic testing in the United States. Am. J. Hum. Genet.81(3) , 635–637 (2007).
  • European Society of Human Genetics (ESHG). Statement of the ESHG on direct-to-consumer genetic testing for health-related purposes. Eur. J. Hum. Genet.12 , 1271–1273 (2010).
  • Committee on Genetics, American College of Obstetricians and Gynecologists; Committee on Ethics, American College of Obstetricians and Gynecologists. ACOG Committee Opinion No. 409: direct-to-consumer marketing of genetic testing. Obstet. Gynecol.111(6) , 1493–1494 (2008).
  • Foster MW , MulvihillJJ, SharpRR. Evaluating the utility of personal genomic information. Genet. Med.11(8) , 570–574 (2009).
  • Myers MF . Health care providers and DTC access and advertising of genetic testing in the US. Genome Med.3(12) , 81 (2011).
  • Udesky L . The ethics of direct-to-consumer genetic testing. Lancet376(9750) , 1377–1378 (2010).
  • Colaiacovo M , GrimaldiKA. Personal genetics, the European regulations maze and the way out. Per. Med.9(5) , 515–522 (2012).
  • Borry P , van Hellemondt RE, Sprumont D et al. Legislation on direct-to-consumer genetic testing in seven European countries. Eur. J. Hum. Genet.20(7) , 715–721 (2012).
  • Soini S . Genetic testing legislation in western Europe – a fluctuating regulatory target. J. Community Genet.3(2) , 143–153 (2012).
  • Lee SS , CrawleyL. Research 2.0: social networking and direct-to-consumer (DTC) genomics. Am. J. Bioeth.9(6) , 35–44 (2009).
  • Juengst ET , Flatt,MA, SetterstenRA Jr. Personalized genomic medicine and the rhetoric of empowerment. Hastings Cent. Rep.35 , 34–40 (2012).
  • Howard HC , BorryP. Is there a doctor in the house? The presence of physicians in the direct-to-consumer genetic testing context. J. Community Genet.3(2) , 105–112 (2012).
  • Evans JP , BergJS. Next-generation DNA sequencing, regulation, and the limits of paternalism: the next challenge. JAMA306(21) , 2376–2377 (2011).
  • Howard HC , BorryP. To ban or not to ban? Clinical geneticists‘ views on the regulation of direct-to-consumer genetic testing. EMBO Rep.13(9) , 791–794 (2012).
  • McBride CM , WadeCH, KaphingstKA. Consumers‘ views of direct-to-consumer genetic information. Annu. Rev. Genomics Hum. Genet.11 , 427–446 (2010).
  • McGowan ML , FishmanJR, LambrixMA. Personal genomics and individual identities: Motivations and moral imperatives of early users. New Genet. Soc.29(3) , 261–290 (2010).
  • Vayena E , GournaE, StreuliJ, HafenE, PrainsackB. Early users of direct-to-consumer genomics in Switzerland. Public Health Genomics15(6) , 352–362 (2012).
  • Chua EW , KennedyMA. Current state and future prospects of direct-to-consumer pharmacogenetics. Front. Pharmacol.3 , 152 (2012).
  • Kitzmiller JP , GroenDK, PhelpsMA, SadeeW. Pharmacogenomics testing: relevance in medical practice. Cleve. Clin. J. Med.78(4) , 243–257 (2011).
  • Gurwitz D , Bregman-EschetY. Personal genomics services: whose genomes? Eur. J. Hum. Genet.17(7) , 883–889 (2009).
  • Rose N . The Politics of Life Itself: Biomedicine, Power, and Subjectivity in the Twenty-First Century. Princeton University Press, NJ, USA (2008).
  • Prainsack B , ReardonJ, HindmarshR, GottweisH, NaueU, LunshofJE. Misdirected precaution? Nature456 , 34–35 (2008).
  • Gurwitz D , LunshofJE. Personalized participatory medicine: sharing knowledge and uncertainty. Genome Med.3(10) , 69 (2011).
  • Wysowski DK , NourjahP, SwartzL. Bleeding complications with warfarin use: a prevalent adverse effect resulting in regulatory action. Arch. Intern. Med.167 , 1414–1419 (2007).
  • Budnitz DS , PollockDA, WeidenbachKN, MendelsohnAB, SchroederTJ, AnnestJL. National surveillance of emergency department visits for outpatient adverse drug events. JAMA296 , 1858–1866 (2007).
  • Kim MM , MetlayJ, CohenA et al. Hospitalization costs associated with warfarin- related bleeding events among older community-dwelling adults. Pharmacoepidemiol. Drug Saf. 19 , 731–736 (2010).
  • Frueh F . On rat poison and human medicines: personalizing warfarin therapy. Trends Mol. Med.18(4) , 201–205 (2012).
  • Cohen JP . Overcoming regulatory and economic challenges facing pharmacogenomics. New Biotechnology29(6) , 751–756 (2012).
  • Harper AR , TopolEJ. Pharmacogenomics in clinical practice and drug development. Nat. Biotechnol.30(11) , 1117–1124 (2012).
  • Flanigan J . Three arguments against prescription requirements. J. Med. Ethics38(10) , 579–586 (2012).
  • Higgs JE , AndrewsJ, GurwitzD, PayneK, NewmanW. Pharmacogenetics education in british medical schools. Genomic Med.2(3–4) , 101–105 (2008).
  • Gurwitz D . Pharmacogenetics education: 10 years of experience at Tel Aviv University. Pharmacogenomics11(5) , 647–649 (2010).
  • Dias MM , DepalaK, WardHM et al. Reforming pharmaceutical education to enhance the global uptake of pharmacogenomics and personalized medicine. Curr. Pharmacogenomics Person. Med. 10(3) , 231–238 (2012).
  • Lunshof JE , GurwitzD. Pharmacogenomic testing: Knowing more, doing better. Clin. Pharmacol. Ther.91(3) , 387–389 (2012).
  • Stanek EJ , SandersCL, TaberKA et al. Adoption of pharmacogenomic testing by US physicians: results of a nationwide survey. Clin. Pharmacol. Ther. 91(3) , 450–458 (2012).
  • Haga S , BurkeW, GinsburgG, MillsR, AgansR. Primary care physicians‘ knowledge and experience with pharmacogenomics testing. Clin. Genet.82(4) , 388–394 (2012).
  • Haga SB , O‘DanielJMO, TindallGM, LipkusIR, AgansR. Survey of US public attitudes towards pharmacogenetic testing. Pharmacogenomics J.12 , 197–105 (2011).
  • Mesko B , ZahuczkyG, NagyL. The triad success in personalised medicine: pharmacogenomics, biotechnology and regulatory issues from a central European perspective. Nat. Biotechnol.29(6) , 741–750 (2012).
  • Paré G , MehtaSR, YusufS et al. Effects of CYP2C19 genotype on outcomes of clopidogrel treatment. N. Engl. J. Med. 363(18) , 1704–1714 (2010).
  • Mega JL , SimonT, ColleetJP et al. Reduced-function CYP2C19 genotype and risk of adverse clinical outcomes among patients treated with clopidogrel predominantly for PCI. JAMA 304(16) , 1821–1830 (2010).
  • Simon T , VerstuyftC, Mary-KrauseM. Genetic determinants of response to clopidogrel and cardiovascular events. N. Engl. J. Med.360(4) , 363–375.
  • Mega JL , CloseSL, WiviottSD et al. Cytochrome p-450 polymorphisms and response to clopidogrel. N. Engl. J. Med. 360(4) , 354–362 (2009).

▪Websites

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.