How did this heart drug get approved in the first place?

In case you believe that the medicine you’re taking has been adequately tested on real live patients before being legally approved, you might want to consider new research published this month in The New England Journal of Medicine*. A heart drug called nesiritide that for the past 10 years has been given to acute heart failure patients in hospital has failed to show any improvement compared to placebo.

But the drug had somehow received FDA approval in 2001 for use on these patients – after initial non-approval. Continue reading