By Dennis Thompson
Originally posted April 12, 2016
Here is an excerpt:
The U.S. Congress in 2012 gave FDA the power to designate a drug as a "breakthrough therapy" if preliminary clinical evidence suggests an advantage over existing medications.
But a survey of nearly 700 doctors revealed that many tended to misinterpret "breakthrough." Doctors often believed the drugs were supported by stronger evidence than the law requires to achieve that designation, said lead author Dr. Aaron Kesselheim. He is a faculty member at Brigham and Women's Hospital in Boston.
"When people hear 'breakthrough,' it gives them an inappropriately elevated sense of what the drug might do," Kesselheim said. "It may give physicians false reassurance about the outcomes they might expect to receive when they prescribe it."
The article is here.