Personalized medicine: part 2: ethical, legal, and regulatory issues.

lion per hospital, depending on size.1 A report from the National Academy of Sciences, published in 2009, emphasized the need to apply a new approach to allow monitoring of each patient’s health status and to treat any malfunction in a manner that is tailored to that individual.2 Thus, the promise of PM, if fully realized, has the potential to significantly influence the nation’s health care. We are inching our way to pharmacogenomics-based prescribing, and we can now offer tests to determine whether patients might benefit from certain drugs—for example, warfarin (Coumadin, Bristol-Myers Squibb), the protein thio purine methyltransferase (TPMT), and several tricyclic antidepressants (TCAs); however, such testing is, for the most part, research-based. In two or three cases, though, the FDA has required testing prior to drug administration, as in the case of trastuzumab (Herceptin, Genentech), yet test-based prescribing is far from the standard of care. In the coming years, advances in pharmacogenetics will convert the “art” of prescribing into a “science,” and with this knowledge, we will no longer need to rely on the dangerous methods of trial-and-error prescribing. Current methods of determining the safety and efficacy of medications, in other words, will eventually become a historical footnote. Today we face significant challenges in adopting safe and effective, personalized diagnostic and therapeutic approaches. Physicians will be the key to achieving the promise. Although tests and companion diagnostics exist to improve prescribing and care outcomes, physicians typically do not have the detailed analyses of clinical information needed to select optimal drug treatments and dosages on the basis of a patient’s unique genetic profile, physiology, and metabolic processes. In the absence of what is needed to know to deliver PM, physicians can easily continue to use a certain amount of trial-and-error methods when they evaluate treatment approaches.