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Comment by seehafer | Hacker News Reader

> The other part: FDA is controlled by the companies that come under its umbrella. Think of the fox guarding the hen house.

People who work at companies that come under its umbrella wish that were true. It's not. There is a revolving door and a lot of pressure back and forth but the relationship is a lot more complicated than "pharma owns the FDA". There are some fire-breathing regulators there (who think they're the only thing preventing Big Pharma from selling us poison) who would slap your face if you told them that.

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No no no, we people who come under its umbrella wish that it wasn't a FOX guarding the henhouse, but rather, a reliable dog. Instead, if we extend the metaphor, the fox that's guarding the henhouse is taking measure to make sure that the chickens are safe from everyone but him, and that fox is getting HUGELY STRONG from chicken dinner ever night, and walks back out into the forest and beats up all us other foxes. We'd love him to be locked out of the henhouse, or even, if necessary, for all us foxes to equally be able to access the henhouse, but instead we've got a massive, roid-raging fox terrorizing the forest, and it's freaking annoying.

The idea here is that small, powerful parts of BIG pharma do functionally control the FDA, and they use the FDA to manipulate the market in their favor - and to the detriment of all smaller players in that space. The fire-breathing regulators out there, they're useful idiots in that battle - convince them of some threat, and like an attack dog, they'll go after it. That wouldn't be so bad, but it's just that some players in big pharma are holding the leash and dictating (or at least strongly influencing) which targets to hit and how to hit them.

(edit: I don't mean to say that some people who work under the FDA's oversight don't feel like you said in your comment, but I'm asserting that in my experience, we feel somewhat differently than that - I felt I should clarify, because you may work there yourself, and the way I put it up above, I sort of excluded the possibility of anyone feeling that way. It's not that I don't disagree with you here, it's that I don't mean to disagree disagreeably. :) )

They have some incredibly blatant corruption. Notably they protect the maker of epipens by refusing to allow approve competing products: http://slatestarcodex.com/2016/08/29/reverse-voxsplaining-dr...

I'm sure there are some people at the FDA that believe they are still doing a good job by preventing bad drugs. But even there they kill far more people than they save by preventing life saving drugs from reaching terminally ill patients, and vastly increasing the cost of producing drugs. They need to be shut down.

They're not refusing to approve competing products. The products refuse to go through the process of being vetted by the FDA.

Get your story straight.

Yes, right, the FDA approval process is so ridiculous no one can even afford to to try. That's much better.

It's not ridiculous. In fact sometimes it's not even thorough enough.

If you can't understand the problems with vetting a device to be used by quite a few people, then you're just being foolish.

Could you provide a rough cost-benefit analysis?

http://www.fdareview.org/05_harm.php

I also recently read The Right to Try about how the FDA delays the approval of drugs for terminal diseases costing countless lives. This is less statistics based, but it shows many absurd decisions by the FDA. Terminally ill people are more than happy to take risks for drugs even if there is a small chance of them working.

The FDA delays approval of drugs even when they are known to be safe, because they haven't yet proven efficacy, which is just silly. In one case they wouldn't approve a drug because they demanded a clinical trial larger than the number of patients that existed with that disease, and way larger than necessary to establish statistical significance.

They ignore data from previous studies and from other countries. So there are cancer drugs that are known to be very effective and have been used for decades in Europe, but still aren't approved in the US. The death toll of this decision alone is enormous. Thousands of people could have been saved if this treatment was allowed in the US, but we are stuck with much less effective, older treatments.

Or they are just underfunded relative to the amount of work they have to do. http://www.npr.org/sections/health-shots/2016/09/01/49223579...

The Slate Star Codex article fails to make the case that lowering the general regulatory thresholds for medical devices or drugs improves societal outcomes. It makes a compelling, if possibly flawed, case for the EpiPen, but assumes generalizability rather than showing it.

We know the costs of not having something like the FDA. All one has to do is look at the supplements industry and imagine if real drugs were like that.

Oh, you thought you were getting what was on the label? Silly you. https://healthyfoodusa.com/fda-finds-majority-of-herbal-supp...

You thought you'd get something that would help? Silly you. http://www.health.harvard.edu/staying-healthy/dietary-supple...

You thought you'd get something that didn't have major unknown side effects? Silly you. http://emedicine.medscape.com/article/817427-overview

Edit:

Also ignored is how the FDA is a major incentive to create something new that both helps with the problem and doesn't generate an unreasonable amount of other ones. If the barriers to market entry are removed, you are putting the informational cost on the consumer. If it's cheaper to fool them than to do the due diligence in development, that's what will be done. And it's pretty clear from the supplement industry that it is cheaper.

Scott Alexander likes to make the future costs of a lack of new medications argument a lot. He has to account for the costs of a lack of new effective medications as well.

Edit 2:

Scott Alexander doesn't try to make the case the FDA is corrupt. He talks about how Mylan uses the court system and lobbies congress. And his point about costs is undercut by a later post he made about coming up with the chairs statistic: http://slatestarcodex.com/2016/08/31/terrorists-vs-chairs-an...

First of all, see my comment above. The FDA costs way more lives than it saves.

Ideally I would like the FDA to be replaced by a more efficient regulatory agency. Europe's system seems to work a bit better. I dream of something like prediction markets, where people could bet on what medicines would work and not work. At the very least, some system designed to make regulators accountable for lives cost due to not approving drugs, just as much as they are accountable for approving bad drugs. Both sides of the tradeoff need to be explicitly acknowledged.

But I'm not confident that nothing at all would be worse than what we have now. Snake oil wouldn't be legal as victims could sue the companies that produced bad medicines for millions. Bad drugs would still be banned on a reactionary basis, rather than preemptively banning all drugs and only approving the ones that can meet a ridiculous threshold. Doctors are not idiots and would do their best to make sure their patients aren't getting snake oil.

I'm not saying this is a perfect system, I'm saying the FDA is so bad it manages to be worse than this.

Agreed. Just take a look at some of the recent FDA decisions that absolutely slapped down the biggest pharma companies. I've worked in the industry for a while and I would say most big pharma tiptoes around the FDA since they can literally make or break you.

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