How can drugs like Ingrezza be allowed to be prescribed if the way they work isn’t understood? Shouldn’t we understand how a drug works before the FDA clears it for use?

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How can drugs like Ingrezza be allowed to be prescribed if the way they work isn’t understood? Shouldn’t we understand how a drug works before the FDA clears it for use?

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This is much more common than you might think. There are many common drugs whose mechanism of action isn’t fully understood. You probably have Tylenol in your medicine cabinet – we don’t know how that works, either.

We don’t know how a lot of drugs work, but that doesn’t mean they don’t. Most trials are done to check for adverse side-effects, rather than to determine the exact chemical pathways used. You don’t know exactly how your iPhone works, but you can still use it to accomplish your goals. Anesthetics used in surgery are famously bizarre and not very well understood at all, but they generally work very well the vast majority of the time. If we waited to have 100% understanding on all drugs, virtually none would be approved. Even Asprin boggles are minds in some applications.

FDA authorization isn’t about making sure of *how* it works, it’s about making sure that it *does* work. “Does what they say” and “is generally safe at *this* dose” are what they’re concerned about.

We still don’t know how turbulence works and we’ve been flying people across oceans for almost a hundred years.

Just because you don’t completely understand how something works doesn’t mean it might not still be useful.

Also, money talks. And selling drugs has been making people money since the dawn of civilization.

Lol, like half of all drugs wouldn’t be available. Surgery wouldn’t be very fun if nearly all our general anesthesia drugs weren’t available. LOTS of drugs have MOAs that aren’t well understood. What matters is that it DOES WORK and that it is SAFE.

Medical drug studies are based on outcomes… understanding how it works isn’t critical to that. At least how the drug is metabolized is usually very well documented.