Abstract

IMAGINE THAT RESEARCHERS have discovered a genetic biomarker in some breast tumors that can help predict whether a woman will have a recurrence of breast cancer and, therefore, whether chemotherapy will be effective. Women who test positive for the biomarker would receive chemotherapy regardless of their other risk factors, and women who test negative would not. Such a treatment approach could save thousands of lives while sparing some women from the toxic side effects of chemotherapy. The situation is hypothetical, but it is one that oncologists and other physicians are grappling with as genetic testing and personalized medicine become more mainstream. Two key issues have emerged from the debate over genetic-based health care. The first is the concern over patient privacy as more and more genetic data are generated and shared over the Internet. The second is the clamor for the Food & Drug Administration to regulate genetic tests to ensure that they measure what ...

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