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Comment by power2u | Hacker News Reader

>The drugs work by suppressing appetite, by increasing metabolism, and by other mechanisms that are not yet fully understood.

Why would FDA approve something which it we don't fully understand?

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I think you'd be shocked by how little we understand about the mechanism of action of a lot of the drugs out there.

The FDA's job is to ensure that approved drugs are (1) safe and (2) efficacious. Knowing the mechanism of action (MOA) of a drug can help further define the safety/efficacy parameters for a drug, but in it's absence you can still get a very good sense of the risk benefit analysis.

The best example of a lack of understanding of drug MOAs is Lyrica (epilepsy drug from Pfizer). The drug was designed to target the GABAase enzyme. It got approved and then several years later it was realized that the main MAO is the drug's impact on the glutamate neurotransmitter, an entirely different MOA.

There are many drugs where this is true. Antidepressants, especially.

http://en.wikipedia.org/wiki/Pharmacology_of_antidepressants

I was going to say this. Most antidepressants are not really understood. Also I have central sleep apnea (brain forgets to breath when sleeping). They give me a machine but they don't know exactly why the machine helps but it does. It's approved for use.

Because you don't need to understand the mechanism of a drug to have a strong understanding of the effects of a drug. Numerous widely proscribed psychiatric drugs have at best conjectured mechanisms of action.

We also don't understand the mechanisms of a very large number of the drugs we use (e.g. anesthetics).

So, what do you think would be the costs and benefits of waiting to approve a drug until we fully understood how produced it's intended effects? Clearly waiting until we understood every possible interaction for a drug would prevent any sort of mistake, but I'm not aware that we understand any drug in that detail. I hope you wouldn't suggest we abandon antibiotics because theres a chance that any given person taking one for the first time might have a unique allergic reaction.

My best guess on the numbers is that waiting to understand all drugs mechanisms beyond existing testing would, over the course of the FDA's history, have saved dozens of lives at the cost of failing to save millions.

Because they're ultimately beholden to big business? I mean, we have no idea how many drugs work yet the FDA goes after 23andme and other organizations (selling stevia as a sweetner before they allowed it recently, etc), etc with questionable motives. I think there's an obvious double standard when it comes to big pharma.

I'm not attacking the FDA per se, but the entire USG. It seems like the buck stops with congress and congress is simply beholden to their financial backers. It doesn't help that SCOTUS is largely conservative (money is speech, citizens united, etc) and the POTUS's direction of the FDA is mystifying as well.

Ultimately beholden to big business? Tell that to all the drug companies who have either had their drug denied by the FDA or pulled after approval [1].

[1]http://www.fda.gov/safety/recalls/

They played the game wrong. There are counter examples of drugs that should never have been approved rushed to approval.

I think my example is pretty good evidence that the FDA isn't "beholden to big business".

Vioxx, Rezulin

http://www.cbsnews.com/news/fda-whistleblower-resigns/

http://en.wikipedia.org/wiki/David_Graham_(epidemiologist)

I hope no one you know is taking Avandia right now.

Really? The FDA just removed safety warnings from Avandia based on new safety data.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/uc...

I'm not arguing that drugs get approved that shouldn't. My argument is that the FDA is not beholden to the pharma industry. Do the pharma industry lie sometimes and drug get approved? Sure, but that's not "beholden".

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