Fast-Tracked Drugs Can Save Lives, But Are They Safe?

July 18, 2017

You might have seen the news last week about a breakthrough new drug that's being hailed as an "astounding" second-chance to treat leukemia relapse. An FDA panel unanimously recommended approval because it's shown such promise in early trials — despite the fact that long-term studies have not yet been completed. In fact, any patient that would be allowed to take this drug would have to be registered and tracked for 15 years, if the panel gets its way with the full FDA.

It's a controversial practice in the drug industry called fast tracking. The president declared a few months ago there should be much more of it, but not everyone thinks it's such a good idea.

Jim was joined by Dr. Aaron Kesselheim, an associate professor of medicine at the Center for Bioethics at Harvard Medical School and an associate physician at Brigham and Women's Hospital, and Patrick Lacey, founder of BeatNB — which he founded to raise money for neuroblastoma research after his son, Will, was diagnosed as a baby with the rare cancer, which had no cure; he's now a healthy 12-year-old boy.


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