Comment by eth0up
2 days ago
Because we couldn't possibly modify
"we have no substantive or high-quality evidence that the drug is unsafe." - (damn all the research showing it is)
--to
"we have no substantive or high-quality evidence that the drug is safe." - (damn all the research suggesting it isn't)
Well, that's as good a green light for an ad campaign as one could ask for. "we don't actually know that it does this." ain't never stopped a motivated pharmaceutical rep before. You have my official endorsement for feeding advil and acetaminophen to all. And protection from dementia is just what America needs. !Win / !Win
Maybe restless leg and depression too! And don't tell me fetuses don't get depressed there in that dark womb. We know damn well they get restless.
Drugs are approved for the specific uses based on extremely high-quality evidence. That evidence balances the benefits against the detectable downsides/costs/side-effects. Those downsides are also on the label.
That's almost entirely generated by the highest quality evidence generation system we could possibly have, which is RCTs. And no, pharma reps actually aren't allowed to encourage (or even talk about) off-label uses of drugs.
I get the sense that you don't know much about this space.
>highest quality evidence generation system we could possibly have, which is RCTs.
The "best we have" does not mean it is good enough for the task at hand. Just saying.
Basically what I am saying is that qualifying something by saying "best we have", does not justify its using on its own..
1. I didn't say "the best we have." I said the best we could possibly have. There is no form of evidence generation, real or hypothetical, greater than the randomized controlled trial.
2. That doesn't necessarily make it always "sufficiently good evidence", but the beauty of statistics is we actually can know – quite precisely – whether a given evidence generation method gives us sufficient certainty. When an RCT is used as evidence for approval, it is not "well you did an RCT so I suppose it's fine." Approvals actually are not dependent whatsoever on the evidence generation method. The only thing that matters is whether you prove – to sufficient statistical certainty – the claims you are making. It's very hard to do this without RCTs (again being the greatest evidence generation form that could exist), which is why they tend to be the default. But you can run an RCT that fails to produce certainty, and your drug application will be denied. You can also get approval based on a non-RCT (but again it's hard to do because statistics).
We've had this discussion before and the crux of the issue is that you do not understand statistics while the people who design, run, and evaluate clinical trials do. I highly recommend taking a statistics course or four.
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