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.
The paper reviewed 31 drugs designated as breakthrough therapies between 2014 and 2016, noting that some of them may significantly help patients while the benefits of others are unclear. The paper was published Wednesday in the New England Journal of Medicine, and the research was funded in part by the John and Laura Arnold Foundation.
This article is exclusive to STAT+ subscribers
Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts.
Already have an account? Log in
To submit a correction request, please visit our Contact Us page.
