May 30, 2012

Medical Professionals Weigh in on Genetic Policy Issues

The American Heart Association (AHA), a leading professional organization focused on cardiovascular (disease) medicine (CVD) has published an interesting and comprehensive overview of many relevant issues at the intersection of genetics, law and medicine that is worth looking at (published in the AHA journal, Circulation). The professional medical organizations (e.g., American Medical Association and others) have lent their expertise and engaged in advocacy on genetic legal issues over the last decade. They have been visible in the gene patent litigation, Association for Molecular Pathology v. U.S. Patent and Trademark Office (AMP v. USPTO) (headed back to court this summer), where they have largely opposed the granting of gene patents and filed amicus briefs in this ongoing litigation. Now, the AHA has provided its professional analysis and policy recommendations on the central legal/political debates in genetic medicine: gene patents (oppose the granting of gene patents); the possible use of genetic information to discriminate in employment and health care (supports the federal Genetic Information Nondiscrimination Act (GINA), and recommends its expansion to life and long-term insurance policies); the very critical issue of regulatory oversight of genetic tests in the marketplace (recommends that the FDA exercise its enforcement discretion to review and advise on the clinical validity of the laboratory-derived tests in genetic testing); further attention to the establishment of solid pharmacogenetic correlations before genetic information is used to guide drug prescribing and to solid research before genetic risk classifications become routine; further work on a consensus patient consent mechanism that would allow study participants to clearly understand the limits and benefits to participation in large-scale genetic studies; some standardization for insurance payment schemes for genetic tests, and, lastly, the AHA calls attention to the need for deeper practitioner training in genetics. Here are links to some earlier stories here on these issues: FDA regulation; pharmacogenomics, genetic discrimination. Some of the issues discussed in the AHA article require legal resolution (gene patents? FDA oversight?) while others are challenges and overtures to the professional field itself (the AHA calls for increasing development of the specialization of CVD and genetics). In sum, this article is a useful cataloging of the issues confronting all practitioners who increasingly make genetically-informed medical decisions (e.g. oncologists, neurologists, etc.) and provides a template and scorecard to monitor these issues.

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