Is there a doctor in the house?: The presence of physicians in the direct-to-consumer genetic testing context

Journal of Community Genetics

Volumn 3, Issue 2, 2012, Pages 105-112

  Howard, Heidi Carmen ^a,b   Borry, Pascal ^a,c  

^a UNIVERSITY OF LEUVEN   (Belgium)

^b UNIVERSITY OF BASEL   (Switzerland)

^c VU UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

Direct to consumer; Ethical; Genetic testing

Indexed keywords

ALCOHOLISM; ALZHEIMER DISEASE; BIOMEDICINE; BIPOLAR DISORDER; CONTINUING EDUCATION; DIRECT TO CONSUMER GENETIC SCREENING; DNA DETERMINATION; DOCTOR PATIENT RELATION; FOOD AND DRUG ADMINISTRATION; GENETIC COUNSELING; GENETIC SCREENING; GENOME ANALYSIS; GENOMICS; HEALTH CARE ACCESS; HEALTH CARE COST; HEALTH CARE PERSONNEL; HEALTH CARE SYSTEM; HEALTH PROMOTION; HUMAN; LABORATORY TEST; MEDICAL CARE; MEDICAL DECISION MAKING; MEDICAL EDUCATION; MEDICAL ETHICS; MEDICAL SOCIETY; PHARMACEUTICAL CARE; PRESCRIPTION; PRIORITY JOURNAL; REVIEW; SCHIZOPHRENIA; SOCIAL ASPECT;

EID: 84860778374     PISSN: 1868310X     EISSN: 18686001     Source Type: Journal    
DOI: 10.1007/s12687-011-0062-0     Document Type: Review

References (56)

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 28:633
4. American College of Obstetricians and Gynaecologists (2008) ACOG Committee Opinion No. 409: Direct-to-consumer marketing of genetic testing. Obstet Gynecol 111:1493-1494
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 11:701
8. Berg C, Fryer-Edwards K (2008) The ethical challenges of direct-to-consumer genetic testing. J Bus Ethics 77:17-31
9. Borry P (2008) Europe to ban direct-to-consumer genetic tests? Nat Biotechnol 26:736-737 (Pubitemid 351961437)
10. Borry P, Howard HC, Senecal K, Avard D (2009) Direct-to-consumer genome scanning services. Also for children? Nat Rev Genet 10:8
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 1:101-106
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 9:51-59
13. Burke W, Emery J (2002) Genetics education for primary-care providers. Nat Rev Genet 3:561-566 (Pubitemid 34746881)
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 319:274-278
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 2011
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 18:1271-1273
22. Field A, Krokosky A, Terry SF (2010) Direct-to-consumer marketing of genetic tests: access does not reflect clinical utility. GeneTest Mo Biom 14:731-732
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 24:795-801
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 5:399-404
25. Foster MW, Mulvihill JJ, Sharp RR (2009) Evaluating the utility of personal genomic information. Genet Med 11:570-574
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 14:246
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 361:245
30. Harris R, Challen K, Benjamin C, Harris H (2006) Genetic education for non-geneticist health professionals. Public Health Genomics 9:224-226 (Pubitemid 44448902)
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 9:161-182
32. Howard HC, Borry P (2009) Personal genome testing: do you know what you are buying? Am J Bioeth 9:11-13
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 11:579-582
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 81:635-637
35. Human Genetics Commission (2010) A common framework of principles for direct-to-consumer genetic testing services. http://www.hgc.govuk/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 87:576-577
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 82:593-599 (Pubitemid 351726114)
38. Ledley F (2002) A consumer charter for genomic services. Nat Biotechnol 20:767 (Pubitemid 34836743)
39. Lee SS, Crawley L (2009) Research 2.0: social networking and direct-to-consumer (DTC) genomics. Am J Bioeth 9:35-44
40. Lurie P (2009) DTC advertising harms patients and should be tightly regulated. J Law Med Ethics 37:444-450
41. MacDonald C, Walton N (2009) Personal genomics: democratization, or empowerment, or 'something'. Am J Bioeth 9:46-48
42. McGuire A, Diaz CM, Wang T, Hilsenbeck S (2009) Social networkers' attitudes toward direct-to-consumer personal genome testing. Am J Bioeth 9:3-10
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 11:588-594
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 20:967-980
45. Mintzes B (2002) For and against: direct to consumer advertising is medicalising normal human experience: for. Br Med J 324:908
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 30:829-846
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 38:807-815
52. Salari K (2009) The dawning era of personalized medicine exposes a gap in medical education. PLoS Med 6:e1000138
53. Singh I, Rose N (2009) Biomarkers in psychiatry. Nature 460:202-207
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 142:284-292 (Pubitemid 44747456)
56. Wadman M (2008) Gene-testing firms face legal battle. Nature 453:1148-1149 (Pubitemid 351913566)