5 ms·

They have some incredibly blatant corruption. Notably they protect the maker of epipens by refusing to allow approve competing products: http://slatestarcodex.c

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-drugs-vs-chairs/ 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.

kvb 10y ago
Could you provide a rough cost-benefit analysis?
- Houshalter 10y ago
  http://www.fdareview.org/05_harm.php 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.
voronoff 10y ago
Or they are just underfunded relative to the amount of work they have to do. http://www.npr.org/sections/health-shots/2016/09/01/492235796/fda-fees-on-industry-havent-fixed-delays-in-generic-drug-approvals 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-supplements-at-gnc-walmart-walgreens-and-target-dont-contain-what-they-claim-instead-cheap-fillers-like-wheat-and-soy-powder/ 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-supplements-do-they-help-or-hurt 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 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-outlier-story/ http://slatestarcodex.com/2016/08/31/terrorists-vs-chairs-an...
- Houshalter 10y ago
  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.
popmystack 10y ago
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.
- Houshalter 10y ago
  Yes, right, the FDA approval process is so ridiculous no one can even afford to to try. That's much better.
  - popmystack 10y ago
    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.

kvb 10y ago

Could you provide a rough cost-benefit analysis?

Houshalter 10y ago
http://www.fdareview.org/05_harm.php 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.

voronoff 10y ago

Or they are just underfunded relative to the amount of work they have to do. http://www.npr.org/sections/health-shots/2016/09/01/492235796/fda-fees-on-industry-havent-fixed-delays-in-generic-drug-approvals 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-supplements-at-gnc-walmart-walgreens-and-target-dont-contain-what-they-claim-instead-cheap-fillers-like-wheat-and-soy-powder/ 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-supplements-do-they-help-or-hurt 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 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-outlier-story/ http://slatestarcodex.com/2016/08/31/terrorists-vs-chairs-an...

Houshalter 10y ago
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.

popmystack 10y ago

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.

Houshalter 10y ago
Yes, right, the FDA approval process is so ridiculous no one can even afford to to try. That's much better.
- popmystack 10y ago
  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.