In April 2016, an FDA committee voted not to recommend acceptance of eteplirsen, a drug designed to treat muscular dystrophy. In September, however, the FDA did approve the drug, following a heated internal debate.
This wasn’t the end of the story, however. What followed was an unusual scientific controversy that played out in the peer-reviewed literature, discussed in a Retraction Watch post this week.
Following the approval of eteplirsen, Ellis Unger and Robert Califf wrote a let