The FDA Should Approve Drugs Based on Evidence, Not Emotions. But a New Law and Trump Spell Trouble.

On Dec. 7, the New York Times ran an inspiring, dangerous story about Celine Ryan, a 50-year-old whose advanced colon cancer was successfully treated with experimental immunotherapy. Inspiring, because researchers repeatedly rejected Ryan’s requests to participate in a clinical trial, but her heroic refusal to accept their verdict led to her eventual admission—and remission. Dangerous, because although the article emphasizes that success in one patient proves very little, Ryan’s story served as powerful anecdotal reinforcement of a widespread and mistaken view that groundbreaking cures are stuck in trial stages, and that patients need to take it upon themselves to fight bureaucratic gatekeepers for access. This type of narrative undermines the necessity of the Food and Drug Administration, whose scientific standards are crucial to keeping medical costs down, preventing health crises, and ensuring objective evaluations of new drugs....
http://www.slate.com/articles/health_and_science/medical_examiner/2016/12/the_21st_century_cares_act_could_be_dangerous_for_everyone.html