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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