Juno and the FDA screwed up. Peo­ple died. What now?

Let’s say it plain and sim­ple: Juno Ther­a­peu­tics $JUNO and the FDA screwed up and pa­tients died.

The day ahead of Thanks­giv­ing, Juno man­aged to once again stun its in­vestors with the news that its lead CAR-T, JCAR015, killed two peo­ple. They died from cere­bral ede­mas trig­gered by neu­ro­tox­i­c­i­ty. And the death toll from brain swelling trig­gered by its tox­ic com­bo has now reached six, in­clud­ing a death in a sep­a­rate study.

Yes, these were very sick peo­ple. But you shouldn’t gam­ble with any­one’s life, even if they’re liv­ing un­der a death sen­tence. And that’s ex­act­ly what Juno and the FDA did do, if you strip the case down to the bare es­sen­tials.

Do we re­al­ly know what’s go­ing on here? an an­a­lyst asked Juno ex­ec­u­tives last week.

The an­swer is an ob­vi­ous ‘no.’

It all start­ed on Ju­ly 7,  when Juno ac­knowl­edged the first three deaths and an­nounced the clin­i­cal hold. On Ju­ly 12, the FDA gave them the green light to re­sume the study.

I sus­pect that Juno ini­tial­ly de­cid­ed to fin­ger flu­dara­bine, one of the pre­con­di­tion­ing agents used to help the en­gi­neered cell ther­a­py pop­u­late and make it more ef­fec­tive, be­cause it was the sim­plest and fastest way to present a case that they could quick­ly make their treat­ment rel­a­tive­ly safe. The al­ter­na­tive was to go back to the draw­ing board and start all over, try­ing to gauge just the right mix of drugs. The FDA bought off on it in record time — on­ly three work days lat­er — and lift­ed the clin­i­cal hold.

I’m not say­ing that top Juno ex­ecs or FDA of­fi­cials were du­plic­i­tous or didn’t be­lieve that they were right. That would be a crime. But they were clear­ly wrong, and Juno reck­less­ly jumped back in­to hu­man test­ing with­out be­ing re­quired by reg­u­la­tors to prove their case and make the prop­er ad­just­ments.

Just a ca­su­al scan of the field would raise se­ri­ous ques­tions about Juno’s lethal­ly flawed judg­ment. Flu­dara­bine is com­mon­ly used in cell ther­a­pies, and specif­i­cal­ly in the ri­val CAR-Ts that Juno was rac­ing to get through the clin­ic. (Once Juno fell be­hind Kite, which us­es flu­dara­bine in its mix, CEO Hans Bish­op made much of the fact that this wasn’t race. But I’ll guar­an­tee you that that is ex­act­ly how an­a­lysts and re­porters have been view­ing this all along, with Juno’s en­cour­age­ment as it aimed at first-mover ad­van­tage or a best-in-class run­ner-up po­si­tion.)

Com­ing hot on the heels of the FDA’s de­ci­sion to ap­prove Sarep­ta’s eteplirsen while most agency in­sid­ers still view it as a deeply flawed ex­per­i­men­tal ther­a­py that could al­so be dan­ger­ous for pa­tients, it’s clear that the FDA has slipped the leash of com­mon sense. The pen­du­lum has swung from over­cau­tious to over-ea­ger to ac­com­mo­date bio­phar­ma in 5 years.

It is a dan­ger­ous and dis­turb­ing sit­u­a­tion. But in­stead of log­i­cal­ly ap­ply­ing a more cau­tious ap­proach where need­ed, it’s more than ob­vi­ous that the sen­ti­ment of the new ad­min­is­tra­tion — and Con­gress — is to con­tin­ue to speed de­vel­op­ment re­gard­less of the cir­cum­stances. Let’s be clear, though, that these new drugs won’t be the “cures” that the gen­er­al pub­lic may ex­pect. They can some­times al­so kill. And it won’t al­ways be dead or slow­ly dy­ing pa­tients on the list.

The FDA needs to un­der­take an in­ter­nal re­view and de­ter­mine what went wrong. This should nev­er hap­pen again. As it stands now, it al­most cer­tain­ly will.


Bioreg­num is an opin­ion col­umn from the ed­i­tors of End­points News

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