Prospects and Problems of Direct-tgo-Public Genetic Tests

• Yoon PW , ChenB, FaucettA et al.: Public health impact of genetic tests at the end of the 20th century. Genet. Med.3 , 405–410 (2001).
   PubMed Web of Science ®Google Scholar
• Adeoye S , BozicKJ: Direct to consumer advertising in healthcare: history, benefits and concerns.Clin. Orthop. Relat. Res.457 , 96–104 (2007).
   PubMed Web of Science ®Google Scholar
• Ling D , BerndtE, KyleM: Deregulating direct-to-consumer marketing of prescription drugs: effects on prescription and over-the-counter sales.J. Law Econ.45 , 691–723 (2002).
   Web of Science ®Google Scholar
• Wilkes MS , BellRA, KravitzRL: Direct-to-consumer prescriptions drug advertising: trends, impact, and implications.Health Aff. (Millwood)19 , 110–128 (2000).
   PubMed Web of Science ®Google Scholar
• Lyles DC : Direct marketing of pharmaceuticals to consumers.Annu. Rev. Public Health23 , 73–91 (2002).
   PubMed Web of Science ®Google Scholar
• Donohue JM , CevascoM, RosenthalMB: A decade of direct-to-consumer advertising of prescription drugs.N. Engl. J. Med.357 , 673–681 (2007).
   PubMed Web of Science ®Google Scholar
• Prescription Drug User Fee Act: Adding Resources and Improving Performance in FDA Review of New Drug Applications. US FDA, Washington, DC, USA (2005).
   Google Scholar
• Schein D : Liability for adverse events in direct-to-consumer advertising.JAMA289 , 2646 (2003).
   Google Scholar
• Henney JE : MSJAMA: challenges in regulating direct-to-consumer advertising.JAMA284 , 2242 (2000).
   PubMed Web of Science ®Google Scholar
• Kravitz RL : Direct-to-consumer advertising of prescription drugs: implications for the patient–physician relationship.JAMA284(17) , 2244 (2000).
   PubMed Web of Science ®Google Scholar
• Lipsky MS , TaylorCA: The opinions and experiences of family physicians regarding direct-to-consumer advertising.J. Fam. Pract.45 , 495–499 (1997).
   PubMed Web of Science ®Google Scholar
• Sellers JA : The two faces of direct-to-consumer advertising.Am. J. Health-Syst. Pharmacy57 , 1401 (2000).
   PubMed Web of Science ®Google Scholar
• Holmer AF : Direct-to-consumer advertising: education or anathema?JAMA282 , 1226–1227 (1999).
   PubMedGoogle Scholar
• Calfee JE : An assessment of direct-to-consumer advertising of prescription drugs.Clin Pharm Ther.82 , 357–360 (2007).
   PubMed Web of Science ®Google Scholar
• Hoffman JR , WilkesM: Direct to consumer advertising of prescription drugs: an idea whose time should not come.BMJ218 , 1301–1302 (1999).
   Google Scholar
• grave;t Hoen E : Direct-to-consumer advertising: for better profits or better health?Am. J. Health-Syst. Pharmacy55 , 594–597 (1998).
   PubMed Web of Science ®Google Scholar
• Bell RA , KravitzRL, WilkesMS: Direct-to-consumer prescription drug advertising and the public.J. Gen. Intern. Med.14651–14657 (1999).
   Web of Science ®Google Scholar
• Young D : FDA examines direct-to-consumer advertising data.Am. J. Health-Syst. Pharmacy60 , 2420–2421 (2003).
   PubMed Web of Science ®Google Scholar
• Gollust SE , HullSC, WilfondBS: Limitations of direct-to-consumer advertising for clinical genetic testing.JAMA288 , 1762–1767 (2002).
   PubMed Web of Science ®Google Scholar
• Hull SC , PrasadK: Reading between the lines: direct-to-consumer advertising of genetic testing in the USA.Reprod. Health Matters9 , 44–48 (2001).
   PubMed Web of Science ®Google Scholar
• Mouchawar J , Hensley-AlfordS, LaurionS et al.: Impact of direct-to-consumer advertising for hereditary breast cancer testing on genetic services at a managed care organization: a naturally occurring experiment. Genet. Med.7 , 191–197 (2005).
   PubMed Web of Science ®Google Scholar
• Tracy E : Are doctors prepared for direct-to-consumer advertising of genetics tests?Obstet. Gynecol.110 , 1389–1391 (2007).
   PubMed Web of Science ®Google Scholar
• Mouchawar J , LaurionS, RitzwollerDP et al.: Assessing controversial direct-to-consumer advertising for hereditary breast cancer testing: reactions from women and their physicians in a managed care organization. Am. J. Mag. Care11 , 601–608 (2005).
   PubMed Web of Science ®Google Scholar
• Gellad ZF , LylesKW: Direct-to-consumer advertising of pharmaceuticals.Am. J. Med.120 , 475–480 (2007).
   PubMed Web of Science ®Google Scholar
• Abel GA , PensonRT, JoffeS et al.: Direct-to-consumer advertising in oncology. Oncologist11 , 217–226 (2006).
   PubMed Web of Science ®Google Scholar
• Murray EM , LoB, PollackL et al.: Direct-to-consumer advertising: physicians views of its effects on quality of care and the doctor–patient relationship. J. Am. Board Fam. Pract.16 , 513–524 (2003).
   PubMedGoogle Scholar
• Wilkes MS , BellRA, KravitzRL: Direct-to-consumer prescription drug advertising: trends, impact, and implications.Health Aff. (Millwood)19 , 110–128 (2000).
   PubMed Web of Science ®Google Scholar
• Gollust SE , WilfondBS, HullSC: Direct-to-consumer sales of genetic services on the internet.Genet. Med.5 , 332–337 (2003).
   PubMed Web of Science ®Google Scholar
• Wolfberg AJ : Genes on the web – direct-to-consumer marketing of genetic testing.N. Engl. J. Med.355 , 543–544 (2006).
   PubMed Web of Science ®Google Scholar
• Ingelfinger FJ : Advertising: informational but not educational.N. Engl. J. Med.286 , 1318–1319 (1972).
   PubMed Web of Science ®Google Scholar
• Leacock S : The Garden of Folly. Dodd, Mead & Co., NY, USA, 133–131 (1924).
   Google Scholar
• Wolfe SM : Direct-to-consumer advertising – education or emotion promotion?N. Engl. J. Med.346 , 524–526 (2002).
   PubMed Web of Science ®Google Scholar
• Federal Trade Commission Facts for Consumers: At-Home Genetic Test: A Healthy Dose of Skepticism May be the Best Prescription. Federal Trade Commission, Bureau of Consumer Protections, Division of Consumer and Business Education (2006).
   Google Scholar
• The direct-to-consumer advertising genie. Lancet369 , 1 (2007).
   PubMed Web of Science ®Google Scholar
• American College of Medicine Genetics Board of Directors: ACMG statement on direct-to-consumer genetic testing. Genet. Med.6 , 60 (2004).
   PubMed Web of Science ®Google Scholar
• Watson MS : Direct to Consumer DNA Testing: Where it Might Fit in Medical Care. Talk given at Massachusetts General Hospital, MA, USA, 10 March 2008.
   Google Scholar
• Mintzes B , BarerML, BassettK et al.: An Assessment of the Health System Impacts of Direct-to-Consumer Advertising of Prescription Medicines (DTCAAA) (Volume III). Patient Information on Medicines Comparative Patient/Doctor Survey in Vancouver and Sacramento. University of British Columbia Health Policy Research Unit, Vancouver, Canada (2001).
   Google Scholar
• Hollon MF : Direct-to-consumer advertising: a haphazard approach to health promotion.JAMA293 , 2030–2033 (2005).
   PubMed Web of Science ®Google Scholar
• Goelen G , RigoA, BonduelleM, de Grève J: BRCA 1/2 gene mutation testing-based cancer prevention and the moral concerns of different types of patients. Ann. NY Acad. Sci.889 , 240–243 (1999).
   PubMed Web of Science ®Google Scholar
• Vogel VG , CostantinoJP, WickerhamDL et al.: Effects of tamoxifen vs raloxifene on the risk of developing invasive breast cancer and other disease outcomes: the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 Trial. JAMA295 , 2727–2741 (2006).
   PubMed Web of Science ®Google Scholar
• Mann GB , BorgenPI: Breast cancer genes and the surgeon.J. Surg. Oncol.67 , 267–274 (1998).
   PubMed Web of Science ®Google Scholar
• American College of Obstetricians and Gynecologists: Committee opinion: update on carrier screening for cystic fibrosis. Obstet. Gynecol.325 , 1–5 (2005).
   Google Scholar

Websites

• Gene Watch UK: Genovations: genetic tests kits. Accessed 30January2008www.quackwatch.com/01QuackeryRelatedTopics/Tests/genovations.html
   Google Scholar
• Gene Tests homepage. Accessed 21February2008www.genetests.org
   Google Scholar
• Genetic alliance: Promotion of genetic testing services directly to consumers. Accessed 30January2008www.geneticalliance.org/ws_display.asp?filter=policy.tmarket
   Google Scholar
• Terry SF: Comments on behalf of the Board of the Genetic Alliance Secretary‘s Advisory Committee on Genetics, Health and Society. Accessed 17March2008www.geneticalliance.org/policy.genetic.testing.oversight
   Google Scholar
• Charkes JS: At-home testing for fatal diseases: do we really want to know? Accessed 30January2008http://jscms.jrn.columbia.edu/cns/2006-11-14/steadmancharkes-athomegenetictesting
   Google Scholar
• 23andme homepage. Accessed 30January2008www.23andme.com
   Google Scholar
• ScientificMatch.com homepage. Accessed 30January2008www.scientificmatch.com/chemistry.htm
   Google Scholar
• Aitkin KJ: The impact of direct-to-consumer prescription drug advertising on the physician–patient relationship. Accessed 31March2008www.fda.gov/cder/ddmac/aikin/index.htm
   Google Scholar
• American Medical Association Board of Trusteest Report 7, Direct-to-Consumer Advertising and Provision of Genetic Testing. Accessed 26June2008www.ama-assn.org/ama1/pub/upload/mm/471/bot7.doc
   Google Scholar
• Myriad Genetics launches direct to consumer advertising campaign for breast cancer test. 2002. Accessed 30January2008www.myriad.com/news/release/333030
   Google Scholar
• Caplan A: Women should be wary of cancer test campaign: TV commercials exploit fear of breast cancer in the guise of education. Accessed 30January2008www.msnbc.msn.com/id/20761643/
   Google Scholar
• Secretary‘s Advisory Committee on Genetics, Health, and Society: US system of oversight of genetic testing: a response to the charge of the Secretary of Health and Human Services. Accessed 26June2008www4.od.nih.gov/oba/SACGHS/reports/SACGHS_oversight_report.pdf
   Google Scholar
• Lei HH: Commercials for Myriad BRCA analysis genetic test under scrutiny. 2007. Accessed 30January2008www.eyeondna.com/2007/09/11/commercials-for-myriad-brcanalysis-genetic-test
   Google Scholar
• National Human Genome Research Institute: Direct to consumer marketing of genetic tests: direct to consumer advertising workshop summary. 2004. Accessed 30January2008www.genome.gov/pfv.cfm?pageID=12010659
   Google Scholar
• CBS News: Home genetic test for disease. 2005. Accessed 30January2008www.cbsnews.com/stories/2005/03/06/health/main678386.shtml
   Google Scholar
• Heinrich J: Prescription drugs FDA oversight of direct-to-consumer advertising has limitations. United States General Accounting Office 2002. Accessed 18July2006www.gao.gov/new.items/d03177.pdf
   Google Scholar
• Genetics and Public Policy Center Issue Brief: Direct-to-consumer genetic testing: empowering or endangering the public? Accessed 30January2008www.dnapolicy.org/policy.issue.php?action=detail&issuebrief_id=32&print=1
   Google Scholar
• Genetic Alliance: Comments to the Food and Drug Administration on direct to consumer marketing of genetic tests. Accessed 17March2008www.geneticalliance.org/ws_display.asp?filter=policy.fda.test
   Google Scholar
• American College of Medical Genetics. ACMG statement on direct-to-consumer genetic testing: genetics professionals should be part of genetic testing process says American College of Medical Genetics. Accessed 26June2008www.acmg.net/AM/Template.cfm?Section=Search2&section=Home_Page_News_Releases&template=/CM/ContentDisplay.cfm&ContentFileID=144
   Google Scholar
• Harmon A: Congress passes bill to bar bias based on genes. New York Times 2008. Accessed 2May2008www.nytimes.com/2008/05/02/health/policy/02gene.html
   Google Scholar
• Nanosphere SEP17 510(k) Summary of Verigene Warfarin Metabolism Nucleic Acid Test and Verigene System. September 17, 2007. Accessed 26June2008www.fda.gov/cdrh/pdf7/K070804.pdf
   Google Scholar