Journal of Community Genetics

, Volume 3, Issue 2, pp 105–112

Is there a doctor in the house?

The presence of physicians in the direct-to-consumer genetic testing context
Original Article

Abstract

Over the last couple of years, many commercial companies, the majority of which are based in the USA, have been advertising and offering direct-to-consumer (DTC) genetic testing services outside of the established health care system, and often without any involvement from a health care professional. In the last year, however, a number of DTC genetic testing companies have changed their provision model such that consumers must now contact a health care professional before being able to order the genetic testing service. In discussing the advent of this new model of service provision, this article also reviews the ethical and social issues surrounding DTC genetic testing and addresses the potential motivations for change, some barriers to achieving truly appropriate medical supervision and the present reality of DTC genetic testing for some psychiatric and neurological disorders. Since the advent of these commercial activities, critics have pointed a finger at the lack of medical supervision surrounding these services. The discussion herein, however, reveals how difficult it may be, despite the addition of a physician, to actually achieve adequate medical supervision within the present context of DTC genetic testing.

Keywords

Direct-to-consumer Genetic testing Ethical 

References

  1. 23 and Me (2011a) 23 and Me democratizes personal genetics. https://www.23andMe.com/about/press/20080909b/ Accessed 29 Apr 2011
  2. 23 and Me (2011b) Health reports: complete list. https://www.23andMe.com/health/all/ Accessed 22 Feb 2011
  3. Allison M (2010) Genetic testing clamp down. Nat Biotechnol 28:633PubMedCrossRefGoogle Scholar
  4. American College of Obstetricians and Gynaecologists (2008) ACOG Committee Opinion No. 409: Direct-to-consumer marketing of genetic testing. Obstet Gynecol 111:1493–1494CrossRefGoogle Scholar
  5. American Medical Association (2008) Direct-to-consumer advertising and provision of genetic testing. www.ama-assn.org/ama1/pub/upload/mm/471/bot7.doc Accessed 23 Feb 2011
  6. American Medical Association (2011) AMA letter to the FDA regarding molecular and clinical genetics panel of medical devices advisory committee. http://www.ama-assn.org/ama1/pub/upload/mm/399/consumer-genetic-testing-letter.pdf Accessed 27 Apr 2011
  7. Anderson EE (2009) Direct-to-consumer personal genome services: need for more oversight. Virtual Mentor 11:701Google Scholar
  8. Berg C, Fryer-Edwards K (2008) The ethical challenges of direct-to-consumer genetic testing. J Bus Ethics 77:17–31CrossRefGoogle Scholar
  9. Borry P (2008) Europe to ban direct-to-consumer genetic tests? Nat Biotechnol 26:736–737PubMedCrossRefGoogle Scholar
  10. Borry P, Howard HC, Senecal K, Avard D (2009) Direct-to-consumer genome scanning services. Also for children? Nat Rev Genet 10:8PubMedCrossRefGoogle Scholar
  11. Borry P, Cornel MC, Howard HC (2010a) Where are you going, where have you been. Direct-to-consumer genetic tests for health purposes. J Comm Genet 1:101–106CrossRefGoogle Scholar
  12. Borry P, Howard HC, Senecal K, Avard D (2010b) Health-related direct-to-consumer genetic testing: a review of companies’ policies with regard to genetic testing in minors. Fam Cancer 9:51–59PubMedCrossRefGoogle Scholar
  13. Burke W, Emery J (2002) Genetics education for primary-care providers. Nat Rev Genet 3:561–566PubMedCrossRefGoogle Scholar
  14. Council of Europe (2008a) Additional protocol to the convention on human rights and biomedicine, concerning genetic testing for health purposes. http://conventions.coe.int/Treaty/EN/Treaties/Html/TestGen.htm Accessed 22 Feb 2011
  15. Council of Europe (2008b) Explanatory report to the additional protocol to the convention on human rights and biomedicine, concerning genetic testing for health purposes. http://conventions.coe.int/Treaty/EN/Reports/Html/TestGen.htm Accessed 22 Feb 2011
  16. Couzin J (2008) Gene tests for psychiatric risk polarize researcher. Science Magazine 319:274–278Google Scholar
  17. Department of Health and Human Services (2011) Summary from the molecular & clinical genetics panel meeting–March 8 & 9, 2011. U.S. Food and Drug Administration, Silver Spring. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MolecularandClinicalGeneticsPanel/UCM246907.pdf, Accessed 22 Aug 2011Google Scholar
  18. DNA Direct (2011) New resources for genetic testing. http://www.dnadirect.com/web/consumers, Accessed 17 Feb 2011
  19. Food and Drug Administration (2010a) FDA/CDRH Public meeting: oversight of laboratory developed tests (LDTs), Date July 19–20, 2010. www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm212830.htm#webcast. Accessed 22 Feb 2011
  20. Food and Drug Administration (2010b) Letters to manufacturers concerning genetic tests. www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm219582.htm Accessed 22 Feb 2011
  21. European Society of Human Genetics (2010) Statement of the ESHG on direct-to-consumer genetic testing for health-related purposes. Eur J Hum Genet 18:1271–1273CrossRefGoogle Scholar
  22. Field A, Krokosky A, Terry SF (2010) Direct-to-consumer marketing of genetic tests: access does not reflect clinical utility. GeneTest Mo Biom 14:731–732CrossRefGoogle Scholar
  23. Fischer MA, Keough ME, Baril JL, Saccoccio L, Mazor KM, Ladd E, Worley AV, Gurwitz JH (2009) Prescribers and pharmaceutical representatives: why are we still meeting? J Gen Intern Med 24:795–801PubMedCrossRefGoogle Scholar
  24. Foster MW, Sharp RR (2008) The contractual genome: how direct-to-consumer genomic services may help patients take ownership of their DNA. Persona Med 5:399–404CrossRefGoogle Scholar
  25. Foster MW, Mulvihill JJ, Sharp RR (2009) Evaluating the utility of personal genomic information. Genet Med 11:570–574PubMedCrossRefGoogle Scholar
  26. Genetics and Public Policy Center (2006) Direct-to-consumer genetic testing: empowering or endangering the public? http://www.dnapolicy.org/policy.issue.php?action=detail&issuebrief_id=32. Accessed 17 Feb 2011
  27. Genetics and Public Policy Center (2011) http://www.dnapolicy.org/resources/AlphabetizedDTCGeneticTestingCompanies11.10.pdf. Accessed 17 Feb 2011
  28. Gilbody S, Wilson P, Watt I (2005) Benefits and harms of direct to consumer advertising: a systematic review. Qual Saf Health Care 14:246PubMedCrossRefGoogle Scholar
  29. Green RC, Roberts JS, Cupples LA, Relkin NR, Whitehouse PJ, Brown T, Eckert SLR, Butson M, Sadovnick AD, Quaid KA (2009) Disclosure of APOE genotype for risk of Alzheimer’s disease. New Engl J Med 361:245PubMedCrossRefGoogle Scholar
  30. Harris R, Challen K, Benjamin C, Harris H (2006) Genetic education for non-geneticist health professionals. Public Health Genomics 9:224–226Google Scholar
  31. Hogarth S, Javitt G, Melzer D (2008) The current landscape for direct-to-consumer genetic testing: legal, ethical, and policy issues. Annu Rev Genom Hum Genet 9:161–182CrossRefGoogle Scholar
  32. Howard HC, Borry P (2009) Personal genome testing: do you know what you are buying? Am J Bioeth 9:11–13PubMedGoogle Scholar
  33. Howard HC, Knoppers BM, Borry P (2010) Blurring lines. The research activities of direct-to-consumer genetic testing companies raise questions about consumers as research subjects. EMBO Rep 11:579–582PubMedCrossRefGoogle Scholar
  34. Hudson K, Byers P, Burke W, Javitt G (2007) ASHG statement on direct-to-consumer genetic testing in the United States. Am J Hum Genet 81:635–637CrossRefGoogle Scholar
  35. Human Genetics Commission (2010) A common framework of principles for direct-to-consumer genetic testing services. http://www.hgc.gov.uk/Client/document.asp?DocId=280&CAtegoryId=10. Accessed 17 Feb 2011
  36. Humphreys G (2009) Direct-to-consumer advertising under fire. Bull World Health Organ 87:576–577CrossRefGoogle Scholar
  37. Janssens AC, Gwinn M, Bradley LA, Oostra BA, van Duijn CM, Khoury MJ (2008) A critical appraisal of the scientific basis of commercial genomic profiles used to assess health risks and personalize health interventions. Am J Hum Genet 82:593–599PubMedCrossRefGoogle Scholar
  38. Ledley F (2002) A consumer charter for genomic services. Nat Biotechnol 20:767PubMedCrossRefGoogle Scholar
  39. Lee SS, Crawley L (2009) Research 2.0: social networking and direct-to-consumer (DTC) genomics. Am J Bioeth 9:35–44PubMedGoogle Scholar
  40. Lurie P (2009) DTC advertising harms patients and should be tightly regulated. J Law Med Ethics 37:444–450PubMedCrossRefGoogle Scholar
  41. MacDonald C, Walton N (2009) Personal genomics: democratization, or empowerment, or ‘something’. Am J Bioeth 9:46–48PubMedGoogle Scholar
  42. McGuire A, Diaz CM, Wang T, Hilsenbeck S (2009) Social networkers’ attitudes toward direct-to-consumer personal genome testing. Am J Bioeth 9:3–10PubMedGoogle Scholar
  43. Mihaescu R, Van HM, Sijbrands EJ, Uitterlinden AG, Witteman JC, Hofman A, van Duijn CM, Janssens AC (2009) Evaluation of risk prediction updates from commercial genome-wide scans. Genet Med 11:588–594PubMedCrossRefGoogle Scholar
  44. Mihaescu R, Detmar SB, Cornel MC, van der Flier WM, Heutink P, Hol EM, Rikkert MGMO, van Duijn CM, Janssens ACJW (2010) Translational research in genomics of Alzheimer’s disease: a review of current practice and future perspectives. Journal of Alzheimer’s Disease 20:967–980PubMedGoogle Scholar
  45. Mintzes B (2002) For and against: direct to consumer advertising is medicalising normal human experience: for. Br Med J 324:908CrossRefGoogle Scholar
  46. Mitchell PB, Meiser B, Wilde A, Fullerton J, Donald J, Wilhelm K, Schofield PR (2010) Predictive and diagnostic genetic testing in psychiatry. Clin Lab Med 30:829–846PubMedCrossRefGoogle Scholar
  47. Navigenics (2011a) Find a physician. http://www.navigenics.com/visitor/about_us/find_a_physician/. Accessed 17 Feb 2011
  48. Navigenics (2011b) How our services work. http://www.navigenics.com/visitor/what_we_offer/how_it_works/. Accessed 17 Feb 2011
  49. Pathway Genomics (2011) Pathway’s genetic insights. https://www.pathway.com/dna-reports Accessed 17 Feb 2011
  50. Psynomics (2011) Psynomics. http://www.psynomics.com/products.php. Accessed 22 Feb 2011
  51. Rodwin MA (2010) Drug advertising, continuing medical education, and physician prescribing: a historical review and reform proposal. J Law Med Ethics 38:807–815PubMedCrossRefGoogle Scholar
  52. Salari K (2009) The dawning era of personalized medicine exposes a gap in medical education. PLoS Med 6:e1000138PubMedCrossRefGoogle Scholar
  53. Singh I, Rose N (2009) Biomarkers in psychiatry. Nature 460:202–207PubMedCrossRefGoogle Scholar
  54. SureGene (2010) SureGene, LLC. http://www.suregene.net/. Accessed 22 Feb 2011
  55. Wade CH, Wilfond BS (2006) Ethical and clinical practice considerations for genetic counselors related to direct-to-consumer marketing of genetic tests. Am J Med Genet C Semin Med Genet 142:284–292Google Scholar
  56. Wadman M (2008) Gene-testing firms face legal battle. Nature 453:1148–1149PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag 2011

Authors and Affiliations

  1. 1.Centre for Biomedical Ethics and LawKatholieke Universiteit LeuvenLeuvenBelgium
  2. 2.Institute of Bio- and Medical Ethics BaselUniversity of BaselBaselSwitzerland
  3. 3.Department of Medical Humanities, EMGO Institute for Health and Care ResearchVU University Medical CenterAmsterdamThe Netherlands
  4. 4.Department of Clinical Genetics, EMGO Institute for Health and Care ResearchVU University Medical CenterAmsterdamThe Netherlands

Personalised recommendations