Thumbs Up/Thumbs Down: Amgen's silence is deafening; The drug pricing mob is back
Endpoints assesses the big biopharma R&D stories of the week, with a little added commentary on what they mean for the industry.
Amgen bugs out, and they’re making everyone in biopharma look bad.
Just about everyone engaged in drug development loves to talk about positive data and how the most important thing about success is always the patient who benefits. But when the light turns red on a setback, the death star mentality dominates and oozing compassion disappears as they clamp down and hunker down in silence. I’ve seen it a thousand times. Amgen, though, just took the bug-out shuffle to a whole new extreme. Their kidney disease drug Parsabiv (etelcalcetide) was cheered through a big Phase III program, leaving everyone waiting for the inevitable approval. But this week we learned that it was rejected by the FDA. Why? Amgen won’t say, or even hint at it. Those patients they recruited to test the drug for the good of all (and to protect a key revenue source for Amgen)? Well, they don’t need to know either. Frankly, the whole thing disgusts me. Want to know why Big Biopharma has such a seedy rep? It’s shady events like this that put it into perspective. To Amgen: At least try to hold yourselves accountable and explain what happened here honestly. Shame on Amgen CEO Robert Bradway and R&D director Sean Harper for allowing it to happen. You need to do better. Much, much better. There are public responsibilities involved in drug development, and you’re shirking them.
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