Comment by chroma

3 years ago

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.

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chroma

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maxbond  3 years ago

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.

  • chroma  3 years ago

    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...

    • maxbond  3 years ago

      It's one thing to say they should approve drugs faster and another thing to say they should rubber stamp anything that Europe and Canada approve.

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  • dghughes  3 years ago

    > thalidomide, a deadly and basically worthless medication,

    Thalidomide is what is used to treat erythema nodosum leprosum (ENL) better known as just leprosy.

    • maxbond  3 years ago

      It used to be regarded as a miracle drug that could be used over the counter in many circumstances, and as they looked into it they discovered it just couldn't be used safely.

      That they've narrowed it down to some use case is more of a testament to the thoroughness of the investigation, I'm sure there are many chemicals that could treat leprosy this just happens to be the one we understand how to manufacture and when it is safe to use.

      I'm sure it's very meaningful for the people who do take it, but that is what I meant by "basically worthless."

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