Bioregnum

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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