But that’s the problem. No regulatory body has perfect judgement, so they’ll all approve some harmful things and ban some helpful things. If you’re so strict that you don’t allow thalidomide, you’ll also ban stuff like beta blockers for an extra decade, causing 80,000 deaths. The argument in favor of loosening restrictions is that it would reduce overall death and suffering.
If you think the fact that thalidomide, a deadly and basically worthless medication, being successfully blocked by the FDA is an example of a problem, then I'm a bit baffled?
If you think that regulatory bodies make mistakes - then surely you want them checking each other's work?
It's very frustrating to feel you are dying just shy of a breakthrough that can save you. I get that. And the author's contention, that they have a right as a human being to join studies that can potentially save them, is entirely reasonable.
But that's an entire universe apart from rubber stamping medications. We should not give the pharmaceutical industry that much credulity.
If pharmaceuticals have improved the length and quality of our lives, it's because they've been kept on the straight and narrow. This isn't a self regulating industry, they have a desperate base of customers and their "sales people" (doctors) are trusted implicitly - they hold a tremendous amount of power and would abuse it at the drop of a hat.
I’m saying that the FDA’s strictness cuts both ways. My beta blocker example was not a hypothetical.
Europe approved the use of beta blockers to prevent heart attacks a decade before the US. Although the FDA approved propranolol in the 1960s, and timolol for glaucoma in 1978, they didn’t approve beta blockers for prevention of second heart attacks until the 1980s. This resulted in the deaths of over 80,000 Americans. Amusingly the New York Times article about this approval brags about how many people will be helped by the previously-banned medicine.[1] Nowhere is it pointed out that so many more people could have been saved if the FDA fast-tracked drugs approved in Europe.
Sure, but they did rubber stamp Fen-phen and Vioxx despite plenty of people within the FDA understanding it should come with a black box warning. The FDA needs a win that's more recent than 1971 if they want to demonstrate their efficacy as regulators.
They approved one drug in under a year in a literal emergency (and it's deeply controversial that they did even that). That doesn't mean they can do that with everything that crosses their desk.
I do buy the author's assertion that people should have right to expose themselves to experimental medicines when it could save their lives though.
But that’s the problem. No regulatory body has perfect judgement, so they’ll all approve some harmful things and ban some helpful things. If you’re so strict that you don’t allow thalidomide, you’ll also ban stuff like beta blockers for an extra decade, causing 80,000 deaths. The argument in favor of loosening restrictions is that it would reduce overall death and suffering.
If you think the fact that thalidomide, a deadly and basically worthless medication, being successfully blocked by the FDA is an example of a problem, then I'm a bit baffled?
If you think that regulatory bodies make mistakes - then surely you want them checking each other's work?
It's very frustrating to feel you are dying just shy of a breakthrough that can save you. I get that. And the author's contention, that they have a right as a human being to join studies that can potentially save them, is entirely reasonable.
But that's an entire universe apart from rubber stamping medications. We should not give the pharmaceutical industry that much credulity.
If pharmaceuticals have improved the length and quality of our lives, it's because they've been kept on the straight and narrow. This isn't a self regulating industry, they have a desperate base of customers and their "sales people" (doctors) are trusted implicitly - they hold a tremendous amount of power and would abuse it at the drop of a hat.
I’m saying that the FDA’s strictness cuts both ways. My beta blocker example was not a hypothetical.
Europe approved the use of beta blockers to prevent heart attacks a decade before the US. Although the FDA approved propranolol in the 1960s, and timolol for glaucoma in 1978, they didn’t approve beta blockers for prevention of second heart attacks until the 1980s. This resulted in the deaths of over 80,000 Americans. Amusingly the New York Times article about this approval brags about how many people will be helped by the previously-banned medicine.[1] Nowhere is it pointed out that so many more people could have been saved if the FDA fast-tracked drugs approved in Europe.
1. https://www.nytimes.com/1982/02/02/science/new-class-of-drug...
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> thalidomide, a deadly and basically worthless medication,
Thalidomide is what is used to treat erythema nodosum leprosum (ENL) better known as just leprosy.
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Sure, but they did rubber stamp Fen-phen and Vioxx despite plenty of people within the FDA understanding it should come with a black box warning. The FDA needs a win that's more recent than 1971 if they want to demonstrate their efficacy as regulators.
I take a derivative, Lenalidomide, for cancer maintenance. I am very glad the FDA approved it.
The FDA can approve a new drug in under a year as we saw with covid vaccines. Every time an effective drug is made and they don't people die waiting.
They approved one drug in under a year in a literal emergency (and it's deeply controversial that they did even that). That doesn't mean they can do that with everything that crosses their desk.
I do buy the author's assertion that people should have right to expose themselves to experimental medicines when it could save their lives though.
Why doesn't it mean that?
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