Is the ‘Breakthrough Therapy’ Process Putting Dangerous Drugs on Store Shelves? image

Healthline, April 17, 2018
Shawn Radcliffe, quoting Jonathan J. Darrow (Student Fellow Alumnus)

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From the article:

A CNN report last week detailed the deaths of more than 700 patients prescribed an antipsychotic therapy drug for Parkinson’s disease.

The Food and Drug Administration (FDA) continues to monitor the use of Nuplazid (pimavanserin). But at this point, federal regulators see no reason to change the existing warnings placed on the medication, reports the San Diego Tribune.

“We don’t know if the drug is causing those deaths at this point,” said Jonathan Darrow, SJD, JD, MBA, a researcher at Harvard Medical School and Brigham and Women’s Hospital in Massachusetts.

“The evidence base is weaker than it might be perceived to be. The common perception is that you need randomized-controlled trials in order to receive FDA approval, and that is often not the case for these breakthrough drugs,” Darrow told Healthline.

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