When ‘Breakthrough’ Drugs Aren’t Actually Breakthroughs: FDA’s Approval Pathway Can Be Misleading image

Kaiser Health News, April 12, 2018
KHN Morning Briefing, quoting Jonathan J. Darrow (Student Fellow Alumnus)


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From the article:

In a review of three years of drugs approved by the Food and Drug Administration under a “breakthrough therapy” pathway, researchers argue that some of the compounds are not actually scientific breakthroughs, which they say could be potentially misleading to the public. “You have newly approved breakthrough therapy drugs that may not be any better than existing treatments, and in some cases, it’s possible they could be even worse,” said Jonathan Darrow, lead author of the paper and faculty member of Harvard Medical School. 

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