Remember all the contrarians complaining about the FDA taking too much time with clinical trials? Well, here's what happens when you skip Phase 2 and cut Phase 3 short. This has risks and would cost $50,000 annually, but we can't tell if it sort-of works or doesn't work at all.
https://twitter.com/PamBelluck/status/1401347077360259073
It's disconcerting. Typically, a drug is approved on surrogate markers because the condition's rarity or the drug's narrow indication make it difficult to do robust clinical trials.
Here that's no issue. The lack of data is due to the company and the FDA.
Here that's no issue. The lack of data is due to the company and the FDA.
https://twitter.com/megtirrell/status/1401918905824784386
The resignations probably need to go farther down the chain as well. The FDA's decision to approve aducanumab was plainly irresponsible.
https://twitter.com/gregggonsalves/status/1403092389359669262
Totally broken drug approval system:
1) Drug could've been tested via clinical trials, but they were cut short, leaving ambiguous results.
2) Drug approved on a hunch.
3) Price is then made up out of thin air because Medicare can't negotiate it down.
1) Drug could've been tested via clinical trials, but they were cut short, leaving ambiguous results.
2) Drug approved on a hunch.
3) Price is then made up out of thin air because Medicare can't negotiate it down.
https://twitter.com/nicholas_bagley/status/1403346115194331137
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