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The Collapse of the FDA

nytimes.com

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Re: The Collapse of the FDA

#191

Post by [deleted] »

nosianu wrote: post #82
ineedaj0b wrote: post #76

i know this is a very political thing now but i've had friends (smart phd people who work industry) very annoyed at the fda for many years, and maybe this collapse is good! the fda started with a noble mission but they've been getting heavy handed. or better cliched - slow handed with getting things certified. you can solve this one or two ways: drop regulation or increase staffing. so many institutions have unnecess…

If you would give a balanced PoV you would not only count the good drugs that could have been, but also list all the bad ones that were fortunately prevented from being released on the public. If you only list one side, your argument is missing something essential. Loosening regulations has an effect not only on drugs that turn out to be very net positive, we will also see more bad ones. Now I'm just waiting for some…

[deleted]

Re: The Collapse of the FDA

#192

Post by freejazz »

mistrial9 wrote: post #157
KaiserPro wrote: post #86

Earlier quoted context omitted.

> why do i need environmental review to stick a shed in my backyard?? Because cowboys make cowboy decisions, which leads to loss of lives. "We're going to build on a flood plane, don't worry we've put in protection" turns out they didnt and the things they did made the flooding worse. > companies have a strong incentive not release bad drugs now Given that fentanyl exists and managed to get through, and was widely pr…

so cowboys meet Darwin and their population drops. An alternative is a "nanny state" where every personal choice must pass regulation. This is as old as the hills, but add new abilities to monitor for compliance at scale; new orders of magnitude advantages for certain high-tech; and new amounts of money in an active and massive economic system. Without prescribing any solution here, is it that much of a stretch to th…

>so cowboys meet Darwin and their population drops.

I'm not sure why you think "let people poison others for profit, their customers will die" is a good argument.

Re: The Collapse of the FDA

#193

Post by rstuart4133 »

JKCalhoun wrote: post #143
LadyCailin wrote: post #87

Earlier quoted context omitted.

It really feels like the US is a failed state at this point, but it just hasn’t had full impact yet. Not really sure how all this destruction (in only half a year!) can be reversed in any meaningful timeframe in the future.

Sadly, I expect it has to founder on the rocks before things will turn for the better. I'm channelling Great Depression —> FDR here. Hopefully a world war is not required.

> Hopefully a world war is not required.

We've already come close to Trump causing a war [0]. However, there is one aspect of the man (that's on display here) that gives me hope. He is a moron who can't take advice, and who appoints other morons (to make him look good?).

If it was Stalin, or Hitler, or Erdoğan or god help us Xi, the USA would be in real trouble. All of them are very competent leaders, who could take their countries in the direction they desired for a decade(s). Trump, well you just have to look at his popularity ratings, or the economy shrinking 0.5% in his first quarter. He could have poured money on the economy and had everyone getting high and merry on debt, while he took in billions in bribes via is cryptocurrencies. But nooooo, no one has a clue why he is perusing his economic policies, probably because there aren't much in the way of clues to be had.

It could have been so much worse. As it is, it looks like most countries have his measure and are working around him. I don't know what made me cringe more: Netanyahu showing Trump his letter of recommendation for the Nobel Peace price, or Trump lapping it up. Before that is was the European leaders showering gifts on him. It was disgusting. And it worked. Such is the art of politics, I guess. If you are dealing with pigs, it must appear to the pig that you enjoy rolling in their shit just as much as they do. All leaders except Putin that is. Putin played him for such a fool that even Trump picked up on it.

[0] https://theconversation.com/trumps-first-term-lies-at-the-he...

Re: The Collapse of the FDA

#194

Post by kevin_thibedeau »

tehwebguy wrote: post #137
temporallobe wrote: post #115

Earlier quoted context omitted.

It’s baffling that TV ads for alcohol and cigarettes are illegal, but pharmaceuticals? That’s free speech!

Pretty sure the cigarette companies are stoked they can’t / don’t have to spend any money on TV ads

Transport yourself back to the 60s when America was great and Fred Flintstone was hawking Winston's.

Re: The Collapse of the FDA

#195

Post by dude187 »

CleaveIt2Beaver wrote: post #172
jaredhallen wrote: post #153

Earlier quoted context omitted.

> current administration Or previous ones.

We get it, all lives matter. The point they're making is that $currentAdministration ran specifically on a platform countering this behavior and have failed to keep those promises, whereas others which ignored it simply did not mention it.

> We get it, all lives matter.

I don't understand what you're getting at here

Re: The Collapse of the FDA

#196

Post by dude187 »

Xss3 wrote: post #171
pedro_caetano wrote: post #71

Worth reminding everyone that, on top of pharma and food, the FDA also regulates medical devices. Insufficient regulation both on approval _and_ inspection of medical devices (thinking surgical applications and implantables for example) is as impactful on patient safety as drugs.

There are serious cyber security implications too. A recent discovery was a heart rate monitor used in hospitals that sent all data, including full patient details, to Chinese servers, and would accept arbitrary code updates from said servers. If you wanted to kill a diplomat, muting or spoofing heart rate data while they have a cardiac event in hospital would be a very sneaky way to do it.

But the FDA didn't stop that...

Re: The Collapse of the FDA

#197

Post by AdieuToLogic »

monero-xmr wrote: post #123
AdieuToLogic wrote: post #51

Earlier quoted context omitted.

>> So you advocate a costly post-harm remediation instead of a preemptive solution provided by governmental regulations > Absolutely. Such solutions tend to be much cheaper and more effective. This is not supported by any credible analysis I am aware of, as the cost of rectifying a problem post hoc has historically been far greater than preventing it in the first place. > If we sold oxycontin over the counter we woul…

People with opiate addiction have access to the cheapest and strongest narcotics ever available on the street. Unfortunately they are of uneven strength and cut with horrors that make their body shut down. I would much prefer they could just buy clean drugs from the pharma companies.

> People with opiate addiction have access to the cheapest and strongest narcotics ever available on the street. Unfortunately they are of uneven strength and cut with horrors that make their body shut down. I would much prefer they could just buy clean drugs from the pharma companies.

Fair point.

This is a complex societal problem having no simple solution. Unfortunately, what you proposed:

  Should allow pharma to sell drugs to the market. Allow 
  people to sue if they are harmed. Do not care about a 
  government agency preventing access to new drugs.
Is not a viable solution either. Government agencies and regulations would be needed in order to ensure pharma's do not increase drug addictiveness or otherwise engage in nefarious activities. Agencies are also an avenue for accountability in distribution, a much cheaper and effective enforcement mechanism than civil lawsuits, and can provide options for people wanting to address their addictions.

Remember, every person who dies from an overdose cannot "sue if they get harmed" as they are dead.

Re: The Collapse of the FDA

#198

Post by amy214 »

kevin_thibedeau wrote: post #33

I wish someone would convince RFK that prescription drug ads are bad for his brand of quack medicine. We could at least get rid of that societal cancer while the rest is torn down.

forget that - suppose ozempic, blood pressure, cholesterol meds were made OTC

I would wager cardiac and arterial disease would plummet.

Re: The Collapse of the FDA

#199

Post by sorcerer-mar »

throwawaymaths wrote: post #187
sorcerer-mar wrote: post #168

Earlier quoted context omitted.

The point is that it's nowhere close to a crapshoot. 99.99999% of drugs ever created are unsafe or ineffective. 99%+ of the drugs you will ever encounter in your life are both safe and effective. That is not a crapshoot. Obviously.

if you are in doubt, propublica has done a huge expose in the major, deliberate lapses of FDA regulation for foreign manufactured drugs https://www.propublica.org/article/fda-drug-loophole-sun-pha...

How is that relevant to my point?

Despite its failures (however many you want to point out), our regulatory regime converts a pipeline of almost universally ineffective and/or dangerous compounds into a marketplace of almost universally safe and/or effective compounds. This is a fact.

Unless you think no one is trying to, would try to, or would deceive themselves into accidentally releasing a dangerous or ineffective compound to consumers?

Re: The Collapse of the FDA

#200

Post by mistrial9 »

freejazz wrote: post #192
mistrial9 wrote: post #157

Earlier quoted context omitted.

so cowboys meet Darwin and their population drops. An alternative is a "nanny state" where every personal choice must pass regulation. This is as old as the hills, but add new abilities to monitor for compliance at scale; new orders of magnitude advantages for certain high-tech; and new amounts of money in an active and massive economic system. Without prescribing any solution here, is it that much of a stretch to th…

>so cowboys meet Darwin and their population drops. I'm not sure why you think "let people poison others for profit, their customers will die" is a good argument.

no - I said nothing like that
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