TAILIEUCHUNG - Personalized Medicine: Issues affecting adoption of personalized medicine

The objective of medicine is to address people’s unavoidable needs for emotional and physical healing. The discipline has evolved over millennia by drawing on the religious beliefs and social structures of numerous indigenous peoples, by exploit- ing natural products in their environments, and more recently by developing and validating therapeutic and preventive approaches using the scientific method. Public health and medical practices have now advanced to a point at which people can anticipate—and even feel entitled to—lives that are longer and of better quality than ever before in human history. Yet despite the pervasiveness, power, and promise of con- temporary medical science, large segments of humanity either cannot access its benefits or choose. | PMC PM Issues 03 21 07 Final Personalized Medicine Issues affecting adoption of personalized medicine Introduction Personalized medicine offers a new paradigm for the development of drugs and the practice of medicine. While the potential benefits ofpersonalized medicine include development of drugs that are safer and more effective for specific disease populations such benefits cannot be realized until certain obstacles to adoption are removed. Obstacles in public policy include uncertain regulatory requirements insufficient insurance reimbursement for diagnostic tests linked to pre-emptive care incomplete legal protections to prevent genetic discrimination the lack of a comprehensive healthcare information technology system and a medical education system that has not taught physicians how to incorporate personalized medicine diagnostics or pharmacogenomics into their practices. A supportive public policy environment would address each of these issues and provide incentives to reinforce emerging business models that accelerate the co-development of drugs and diagnostic tests. Understanding all of these key factors - from obstacles to incentives - is a necessary step in determining how to apply resources to influence the direction of personalized medicine and its progress. Genetic privacy and non-discrimination Key issues Federal and state laws provide only a patchwork of protection against misuse of genetic information. The Genetic Information Nondiscrimination Act would fill gaps in current laws protecting genetic information . HIPAA but it has not yet been passed by Congress. Surveys indicate that the public may be inhibited from full participation in personalized medicine research or clinical care unless full genetic privacy protections are put into place. Currently federal and state laws offer only a patchwork of protection against the misuse of genetic information Council for Responsible Genetics 2004 . A number of key acts of federal legislation provide .

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