FDA-designated ‘breakthrough’ therapies may not actually be scientific breakthroughs image

Stat, April 11, 2018
Ike Swetlitz, quoting Jonathan J. Darrow (Student Fellow Alumnus)


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From the article:

WASHINGTON — 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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