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Biomedical subjects

Benjamin S Wilfond

Publications and source records attributed to Benjamin S Wilfond.

8 recordsLinked to original sources

Limitations of direct-to-consumer advertising for clinical genetic testing.

Although direct-to-consumer (DTC) advertisements for pharmaceuticals have been appearing in the mass media for 20 years, DTC advertisements for genetic testing have only recently appeared. Advertisements for genetic testing can provide both consumers and physicians with information about test availability in an expanding market. However, 3 factors limit the value and appropriateness of advertisements: complex information, a complicated social context surrounding genetics, and a lack of consensus about the clinical utility of some tests. Consideration of several advertisements suggests that they overstate the value of genetic testing for consumers' clinical care. Furthermore, advertisements may provide misinformation about genetics, exaggerate consumers' risks, endorse a deterministic relationship between genes and disease, and reinforce associations between diseases and ethnic groups. Advertising motivated by factors other than evidence of the clinical value of genetic tests can manipulate consumers' behavior by exploiting their fears and worries. At this time, DTC advertisements are inappropriate, given the public's limited sophistication regarding genetics and the lack of comprehensive premarket review of tests or oversight of advertisement content. Existing Federal Trade Commission and Food and Drug Administration regulations for other types of health-related advertising should be applied to advertisements for genetic tests.

Advertising↗

Emerging ethical issues in pharmacogenomics: from research to clinical practice.

Pharmacogenomics holds much promise for the application of genetic information to the improvement of clinical care. Ethical issues for pharmacogenomics arise at the intersection of the spheres of drug development and genetic testing. Clinical drug trial designs which use subject selection based on genotype must consider the features of scientific validity, social value and risk-benefit ratio, and later, the impact of this strategy on post-market studies and clinical use of drugs. Although the testing context for pharmacogenomic tests is different from other genetic tests, decisions to use any new clinical tests in medical practice will require evaluation of not only the benefit linked to improved drug use but also the risks arising in part from the scale of testing, predictive value and collateral potential of the genetic test. Integration of pharmacogenomic information into clinical practice will require clinical trials to assess their clinical usefulness, including the impact of tests on therapeutic outcomes. Trials will also be needed to demonstrate the effectiveness of education, informed consent and counseling.

Animals↗

Direct-to-consumer sales of genetic services on the Internet.

PURPOSE The increasing use of the Internet to obtain genetics information and to order medical services without a prescription, combined with a rise in direct-to-consumer marketing for genetic testing, suggests the potential for the Internet to be used to sell genetic services. METHODS A systematic World Wide Web search was conducted in May 2002 to assess the availability of genetic services sold directly to consumers on the Internet. RESULTS Out of 105 sites that offered genetic services directly, most offered non-health-related services, including parentage confirmation testing (83%), identity testing (56%), and DNA banking (24%); however, health-related genetic tests were offered through 14 sites (13%). The health-related genetic tests available ranged from standard tests, such as hemochromatosis and cystic fibrosis, to more unconventional tests related to nutrition, behavior, and aging. Of these 14 sites, 5 described risks associated with the genetic services and 6 described the availability of counseling. CONCLUSIONS The availability of direct sales of health-related genetic tests creates the potential for inadequate pretest decision making, misunderstanding test results, and access to tests of questionable clinical value.

Commerce↗

Screening policy for cystic fibrosis: the role of evidence.

Setting priorities about medical services, including genetic testing services, often occurs in an extemporaneous fashion. Normative assumptions may not be examined critically, although doing so is a necessary component of making health policy decisions about clinical practice. The normative dimension to health policy questions suggests a need for greater public participation in the development of clinical practice guidelines. The experiences of newborn screening and carrier screening for cystic fibrosis in the United States can be examined within the framework of two models of health policy development that help explain the role in health policy development of normative assumptions and public participation. Specifically, this paper focuses on assumptions about what counts as sufficient empirical data to make health policy decisions.

Community Participation↗