Health Affairs April 13, 2018
Gillian Woollett, Bruce Pyenson

Perhaps the greatest turning point in the history of medicine occurred sometime in the 20th century when medical practice started doing more good than harm. While “First, do no harm” is always sound advice, it may not lead to optimal outcomes. Today’s regulators have succeeded fabulously in their charge by minimizing the risks of large-scale catastrophes such as the tragedies caused by the administering of sulphanilamide elixir, (an improperly prepared sulfanilamide medicine, which led to the 1938 Food, Drug, and Cosmetic Act) or thalidomide, but that has not saved us from the opioid epidemic. Meanwhile, critics complain that the Food and Drug Administration’s (FDA’s) deliberate processes delay approvals at the expense of patients. Is there an alternative that can better...

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