Cardiovascular safety was tested in the original trial. It passed. Nothing in the data during development suggested it was an issue. But trials can’t detect everything.
It wasn’t until it got to market did a safety signal pop up. Then retrospective analyses of large data sets proved it.
No one is under the illusion it’s perfect or ungameable. A drug slipping by every few years is bad and often tragic, but IMO nowhere close to indicative of a systematic problem. It is a system that is worthy of a high degree of trust.
I'm unfamiliar with Vioxx and whether its approval really was a result of mistakes.
Shouldn't we expect some small percentage of failures in these processes given that they are driven by statistics and confidence intervals? Is that even a failure of the process, or is it a known limitation given how much resources and time we are willing to allocate to the discovery process?
refurb|1 year ago
Cardiovascular safety was tested in the original trial. It passed. Nothing in the data during development suggested it was an issue. But trials can’t detect everything.
It wasn’t until it got to market did a safety signal pop up. Then retrospective analyses of large data sets proved it.
llamaimperative|1 year ago
No one is under the illusion it’s perfect or ungameable. A drug slipping by every few years is bad and often tragic, but IMO nowhere close to indicative of a systematic problem. It is a system that is worthy of a high degree of trust.
jackcosgrove|1 year ago
Shouldn't we expect some small percentage of failures in these processes given that they are driven by statistics and confidence intervals? Is that even a failure of the process, or is it a known limitation given how much resources and time we are willing to allocate to the discovery process?