`...would rather lose a lot of good drugs than approve a bad drug.`
Thanks for saying this, and rightfully so! Approving a bad drug in the world where distribution channels are very well set up could have disastrous effects.
We can point to things like the opioid crisis in the USA right now - a drug that is so addictive it should have never been put into use the way it was.
It is a matter of diminishing returns already somewhat accounted for in the approval process. Cancer drugs are under far more lax standards given the alternative is death by cancer as even an ironically carcinogenic cancer treatment which gives it again later is preferred to dying of it now.
As opposed to a slightly better allergy pill which more caution may be afforded. Not perfect by any means but it isn't totally blind.
Not sure what sort of evidence you're looking for. There are certainly approved life-saving and other valuable drugs. If they had been approved sooner they would have had a greater benefit. There is an institutional bias towards avoiding costs due to approving a bad drug versus delaying approval and incurring unseen costs.
This seems like a difficult thing to test maybe even unethical. In order to detect the rate of false negatives you would have to re-test drugs that were shut down for being too risky.
The public seems able to understand that there is a cost/benefit tradeoff in driving cars. They could probably understand that idea in the case of drug approval also.
People accept the risk of driving because they feel like they're in control and can prevent a bad outcome. The same is not even remotely true about a drug.
I agree. I think this is why self driving cars will be difficult for society to accept. It's an odd topic because most people would never want to drive their own plane, yet willingly get on airplanes with some % chance they will crash.
The notion that there is some % of cars that will crash seems more palatable when you're the one driving rather than some robot. Or maybe that's just because I pretend I'm a better driver than the self driving cars. This sort of "I could do it better..." psychology is probably what drives these behaviors.
I can't build a better drug; .'. I trust that medical professionals will keep me safe.
I can't fly the plane in a safer manner; .'. I trust that pilots will keep me safe.
I might be able to drive in a safer manner; .'. I don't trust a self driving car.
>Thanks for saying this, and rightfully so! Approving a bad drug in the world where distribution channels are very well set up could have disastrous effects.
Denialism's Michael Specter disagrees. Vioxx was one solution to the pain problem but 2.4% of participants showed heart problems when using it, so it was pulled off shelves. That's like saying no, 97.6% of the population can't have penicillin because 2.4% are allergic to it.
Yes, exactly. Seems better than a blanket ban. As pointed out elsewhere, the FDA is basically trying to keep dramatic risks/outcomes low, to maintain confidence in approved drugs, but tends to have a high false negative rate. What's interesting is that Vioxx was approved, but later appeared to have huge negative impact when it was given to large numbers of people (and apparently, it was also evident in the raw clinical trials data which was submitted to FDA).
It's an entirely non-trivial, multi-dimensional, systemic problem.
Thanks for saying this, and rightfully so! Approving a bad drug in the world where distribution channels are very well set up could have disastrous effects.
We can point to things like the opioid crisis in the USA right now - a drug that is so addictive it should have never been put into use the way it was.