Clinical pharmacology and therapeutics
-
The biological and medical importance of epigenetics is nowtaken for granted, but the significance of one aspect of it—epigenetic inheritance—is less widely recognized. New datasuggest that not only is it ubiquitous, but both the generationand the transmission of epigenetic variations may be affectedby developmental conditions. Population studies, formalmodels, and research on genomic and ecological stressesall suggest that epigenetic inheritance is important in bothmicro-and macroevolutionary change.
-
Clin. Pharmacol. Ther. · Oct 2012
ReviewWithout an adequate ethical infrastructure, the road to personalized medicine will be rocky at best.
Discovering the genetic variations that create profiles of risk and drive individual responses to drugs and vaccines has proven more difficult than many initially presupposed. Rhetoric about the prospect of personalized medicine has exceeded the ability to deliver on that vision. There also remain significant ethical and policy obstacles that may hinder the arrival of personalized medicine. The emergence of new prenatal genetic tests make the resolution of these ethical challenges imperative.
-
The Orphan Drug Act seeks to meet a utilitarian goal of advancing therapeutic options for patients with rare diseases. However, data show that orphan drugs are often approved with more limited premarket testing than that carried out for nonorphan drugs and consequently expose patients to more risk and less certain efficacy. Therefore, the ethical principles of justice and beneficence may require attention to informed consent among patients receiving the drugs and greater investment in postmarket surveillance and confirmational testing.