When "they come down hard on you" the reality is that they're doing a huge disservice to patients ... Did I mention that I despise bureaucracies?
It seems that the FDA bureaucracy's job is to come down hard on Ariad so that the company can be destroyed, so that doctors fear their patients are going to die, and so that patients panic.
"Ponatinib was pulled by the FDA under VERY suspicious circumstances. They changed the definition of what constitutes an adverse event, then attributed every event to the drug, despite the fact that these patients were heavily pretreated and in BLAST phase. They came to the study at deaths door after failing all other options." http://news.yahoo.com/fda-cancer-czar-floats-change-drug-review-process-120000099.html
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