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The Collapse of the FDA

nytimes.com

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Re: The Collapse of the FDA

#181

Post by terminalshort »

os2warpman wrote: post #180
terminalshort wrote: post #173

Earlier quoted context omitted.

Good question. I have narcolepsy. There is a medication called TAK-861 which is the first drug to actually treat the root cause of the disease. It has passed phase 1 and 2 trials proving it is safe and effective. My doctor is involved in the research has said he wishes he could prescribe it to me now, but it is still in phase 3 trials and will not be approved by the FDA for another 2 years, so he can't give it to me.…

>will not be approved by the FDA for another 2 years, so he can't give it to me. edit: I wrote a bunch of bullshit and then deleted it but the points are: 1. Narcolepsy sucks 2. The FDA can't stop your doctor from giving you TAK-861, the likely culprit is Takeda. It is 100% legal for Takeda to sell Oveporexton so long as they don't claim that it treats narcolepsy until it has been approved, and it is 100% legal for y…

It may not be the FDA that is directly responsible here, but if the FDA approved it tomorrow, all my problems will go away. That's because, as you mentioned, our system relies on bureaucratic stamps of approval to adjudicate responsibility rather than anything real. Doctors who prescribed oxycontin and harmed their patients get off scot free because they can just say "but I was told it wasn't addictive" because it has this stamp of approval.

I will certainly take a look at those links as they may help me, but this doesn't change my opinion on the state of things. It infuriates me that I have to jump through all these bureaucratic hoops to get what I need. There is a company with a product they want to sell, and a customer who wants to buy it. The fact that they won't just sell it to me is an indication that our system is fundamentally broken.

I put little weight on the fact that the FDA in particular isn't outright banning me access. They are just one arm of the bureaucratic squid that is strangling me. The FDA says "take this at your own risk" which is on the face of it a fair statement. But they know that the civil liability system, which is just the other arm of the squid, will deny me the ability to actually take my own risk. And they know that the arm of the squid that mandates Takeda can't sell me the medicine without the approval of a doctor means that I won't be able to get through that bureaucratic gatekeeper. So the whole system works together against me while ensuring that no part of it can be blamed because it isn't the decision of any one part that prevents me from getting it, but rather the interaction between these parts. This is why "burn it all down" is such a popular position.

Re: The Collapse of the FDA

#182

Post by s1artibartfast »

Amezarak wrote: post #178
s1artibartfast wrote: post #177

Earlier quoted context omitted.

This all seems entirely reasonable. This is a cost benefit calculation. If bad drugs kill 1 person, and drug shortage kills 100, what do you choose? The FDA chose a practical middle ground. Ban what isn't critical, and for those that are, they put additional mitigations in place: > Exempted drugs were sent to the United States in a “phased manner,” the company said, with third-party oversight and safety testing. >“Th…

Then they should have been transparent about it.

I probably agree with transparency, there is very little information on the ways in which the FDA was not transparent.

the article states "And the agency kept the exemptions largely hidden from the public and from Congress."

How so, are the examples?

The FDA maintains a public red list of companies with import bans, and a green list companies operating under exemptions.

What transparency are we talking about?

Re: The Collapse of the FDA

#183

Post by shadowgovt »

terminalshort wrote: post #156
shadowgovt wrote: post #145

Earlier quoted context omitted.

People tend to be annoyed by things they interact with frequently. I get annoyed by web development, but I wouldn't want to see the solution be a federally mandated burning to the ground of the HTML standard.

Would you like to see a HTML standard imposed by law and that takes years and billions of dollars to amend? I don't think you would like that either. If I had to choose between the two, I'll take the wild west no standard option.

You're asking me if I, as a full-time web developer, would like to see an HTML standard that is incredibly expensive to modify? A standard that could be relied upon to be bedrock atop which you could build frameworks and polyfill to bridge any arbitrary issue you may encounter between the underlying interface and the developer's interface, for years if not decades? A concrete, unyielding standard the browser implementers could forever optimize towards, confident their optimizations won't run afoul of a change to the standard coming down the pipe, or an entirely new feature in the standard that demands novel support at the cost of breaking abstractions that supported the existing standard?

... is there, like, a change.org petition I can sign in favor of this? ;)

Re: The Collapse of the FDA

#184

Post by KaiserPro »

LorenPechtel wrote: post #170
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…

Fentanyl is not a bad drug. It's deadly *on the street* because of it's tendency to clump, meaning that your average drug dealer is not competent to dilute it properly. That's not a problem when handled by professionals.

my friend, opiods out of acute settings are super bad.

Being prescribed opiods to take home, is a sure fire way to get someone addicted https://www.gov.uk/drug-safety-update/opioids-risk-of-depend...

What is even more bad is companies running competitions to encourage family doctors prescribe opiods for long term use.

sure heroin on the streets is bad, don't get me wrong, but giving it to unsuspecting patients, getting them addicted and then effectively forcing them onto the streets is even worse.

Advertising of drugs is fucking stupid, bribing doctors is even more stupid. But as thats where a lot of money comes for politics, its not going to change.

Re: The Collapse of the FDA

#185

Post by atmavatar »

roenxi wrote: post #131
3D30497420 wrote: post #80

Earlier quoted context omitted.

As the adage goes, "regulations are written in blood". The problem is the blood was spent before many people can remember (or bother to remember). They just know the "limitations" imposed by those regulations and therefore want to get them removed.

They also would like it if occasionally everyone reviewed legislation in light of whether it actually had a positive cost-benefit. The claim has to be something significantly more valuable than a few 100 people dying from poisons each year for the thousands to millions of deaths caused by inefficiencies in the biomedical industry. 3,000,000 people die in the US each year right now. Optimising the medical system for n…

> The claim has to be something significantly more valuable than a few 100 people dying from poisons each year for the thousands to millions of deaths caused by inefficiencies in the biomedical industry.

It's extremely misleading to argue with confidence that even a significant fraction of those thousands to millions of deaths would be prevented if only we had the good sense to eliminate medical regulations entirely and that doing so would only result in a few hundred deaths.

It's not just about poisoning deaths from toxic medicine -- it's also about additional deaths from people taking snake oil treatments over proven effective treatments. If the US response to COVID shows us anything, it's that this latter group can be quite significant.

A big problem that's led us to where we are is that many in the right wing fringes that brought us the current administration make their fortunes off selling snake oils in the form of supplements. And while I'm sure some will immediately point out that left wing fringes have their own bullshit cures (e.g., essential oils, healing crystals, etc.), the difference is that this group is still treated as the kooks they are.

Re: The Collapse of the FDA

#186

Post by KaiserPro »

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…

The point of the nanny state is to stop aggressive actors causing widespread harm.

not allowing companies to poison people for profit, ensuring people are qualified to do safety critical jobs. Making sure that companies can't cut OSHA for profit, ensuring that buildings are built to withstand the weather properly, even though it costs more.

A lot of the "nanny state" shit is there because people died. Now, of course some of it is because conservatives/liberals/that class you don't like got their knickers in a twist as well. But that tends to disappear pretty quick.

But that means that big money can use that as a spring board to remove expensive regulation.

You want clean air? but thats expensive! nevermind, soot spewing engines is manly, everything else is what those people you don't like do.

You want social media to stop sending porn to tweens? freedom of speech my friend! thats what makes america better than communism. You want your child to read the great american novels? oh did we say freedom of speech? no we meant don't do our country down.

All of that is theatre, what matters is the food and drugs you eat are safe, effective and well controlled so that the most amount of good is allowed with the least amount of harm

Re: The Collapse of the FDA

#187

Post by throwawaymaths »

sorcerer-mar wrote: post #168
throwawaymaths wrote: post #163

Earlier quoted context omitted.

> We know for a fact (like actual empirical fact) that FDA prevents vast numbers of unsafe and ineffective drugs from reaching the market. This is absolutely indisputable. we also know for a fact that the FDA lets unsafe and ineffective drugs into the market, especially from overseas, slapped with a label that its safe according to the FDA. if its a crapshoot, what's the point really?

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...

Re: The Collapse of the FDA

#188

Post by lcnPylGDnU4H9OF »

kelseyfrog wrote: post #53
sorcerer-mar wrote: post #20

Earlier quoted context omitted.

Sooo that sounds like there's a whole lot of ways for it to get way, way, way worse. The existence of problems does not imply there cannot be more plentiful, more diverse, and more severe problems in the near future.

If Chesterton's fence doesn't have a working latch, then it's appropriate to remove it entirely.

This doesn't really make sense, especially to the Chesterton's Fence parable. If it doesn't have a latch and you don't know why it doesn't have a latch...

Re: The Collapse of the FDA

#189

Post by andrewflnr »

sorcerer-mar wrote: post #109
andrewflnr wrote: post #37

Earlier quoted context omitted.

They obviously weren't referring "specifically" to the FDA at that point.

It seems to me they were referring to FDA as a member among other "oppressive regimes" that fail in this way.

The FDA didn't take 250 years to build up.

Re: The Collapse of the FDA

#190

Post by missedthecue »

chasd00 wrote: post #138
clumsysmurf wrote: post #8

“FDA’s war on public health is about to end,” Kennedy wrote. “This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can’t be patented by Pharma." Anyone know what chelating compounds he is talking about…

The raw milk thing is funny to me in a semi-morbid way i guess, i find it for sale all over the place and more expensive then just regular, even organic, whole milk. Pasteurization doesn't seem to be some evil ultra-processing of milk, it just kills bacteria that can make you sick. There's no preservative or other additives that i'm aware of. Pasteurization just doesn't seem like something anyone would get worked up…

Well the thing is that they want the enzymes and bacteria that pasteurization kills. There is limited (but existing) published research that shows the naturally existing enzymes aid digestion and immune function.

Back about 15 years ago before it became a weird culture war issue, my sister, who had a diagnosed casein allergy (casein is the main protein in milk), found that she could consume raw milk without any adverse effects.

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