Ron Winslow’s “Is there a Heart Attack in Your Future?” published in last week's The Wall Street Journal recently introduced the public to Navigenics, Inc., a California based corporation offering direct to consumer genetic testing services. For $2,500, a customer may order a kit to collect a saliva sample to send to Affymetrix, Inc., which uses a SNP sorting chip and returns results to Navigenics. With a username and a password, customers may then view the results of their genetic predisposition to twenty genetic diseases and compare their risks to those of the generalized population. The fee includes telephone consultations with a genetic counselor and one year of updates on new SNP disease validations.
Navigenics professes a dedication to presenting “complex scientific and medical information to you in an easy-to-understand format.” Yet the very nature of evaluating disease risk based on a single SNP is inherently complicated. Disease risk must be interpreted in the context of an individual’s complete genetic sequence in addition to environmental factors. These limitations may frustrate consumers expecting immediate and definitive results from this online service.
Several critics of direct to consumer genetic tests (DTC), including David P. Hamilton of VentureBeat, have pejoratively referred to the process as “corporate genomics.” By selling these DTC genetic tests and services as merely another online product, these companies by-pass the physician-patient relationship and do not benefit from this traditional way of assessing the importance personal genetic and medical information. Navigenics’ co-founder and chief scientific officer Dietrich Stephan noted that eliminating this relationship may minimize individuals' concerns about breaches of patient confidentiality and the loss of genetic privacy. Responding to a deficiency of legal protection for the privacy of genetic information by attempting to circumvent recording and communicating that information with one’s physician constitutes a logically faulty solution and could lead to even more adverse effects to members of the public. Lay understanding of these tests may lead to over-inclusive or under-inclusive interpretation of the results, which (in both instances) potentially leaves the individual confused and isolated. Based on a (mis)understanding of their personal results, Individuals may be less likely to seek face-to-face treatment from their physicians and genetic counselors. Other individuals, burdened by an unnecessary anxiety, will increase their visits to primary care physicians and thereby exacerbate the inequitable allocation of health care--patients with more pressing medical needs may wait longer and pay more for treatment.
A survey published earlier this year by the Genetics and Public Policy Center (download the PDF) shows that some state legislatures have attempted to address the complexity of DTC genetic tests by placing restrictions on whether the state will allow consumers to circumvent physicians in the receipt of information about their genetic predisposition to disease. As Steve Murphy, of The Gene Sherpa, recently noted, several state laws explicitly prohibit DTC testing, or require an individual’s consent to perform each individual genetic test and a separate consent to retain the individual’s genetic sample. These extensive statutory requirements for separate consent reflect the principle that individuals should fully understand the limitations and implications of each genetic test- preferably through in-person interaction. This purchase has inordinately more significance than most other online transactions, and the law is designed to reflect this difference. What is the benefit of more genetic information, if patients lack the training to interpret its significance? And what will be the personal, legal and social consequences of evading of current informed consent requirements? -- Katherine Drabiak
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