An­oth­er price-goug­ing CEO proves the sys­tem is bro­ken, un­der­scor­ing need for prin­ci­pled re­form at the FDA

End­points News as­sess­es the big bio­phar­ma R&D sto­ries of the week, with a lit­tle added com­men­tary on what they mean for the in­dus­try.

Our new poster boy for drug prof­i­teer­ing proves the sys­tem is bro­ken

Last week­end, I looked over a slide de­tail­ing the clin­i­cal tri­al work that Marathon did to win an ap­proval for de­flaza­cort as a treat­ment specif­i­cal­ly for Duchenne mus­cu­lar dy­s­tro­phy. The steroid is used out­side the US for all sorts of dis­eases, in­clud­ing rheuma­toid arthri­tis. And it’s cheap. Marathon gath­ered some old ef­fi­ca­cy da­ta on Duchenne, added some new stud­ies re­lat­ed to drug ac­tiv­i­ty and so on, and then priced it at $89,000. I’m not a tri­al ex­pert. I don’t de­sign and run stud­ies. But I’ve been talk­ing to biotech ex­ecs about ex­act­ly this kind of work and what it costs for 14 years. One look at the slide they put to­geth­er for Duchenne fam­i­lies would tell any­one, even with the lim­it­ed ex­po­sure I have, that they paid a rel­a­tive­ly small sum for the work they did. Two ex­perts I know agreed.

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