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The Collapse of the FDA

nytimes.com

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Re: The Collapse of the FDA

#111

Post by sorcerer-mar »

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.

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.

So uhhh, maybe we think in reality instead of offloading to metaphor.

Re: The Collapse of the FDA

#112

Post by infecto »

Amezarak wrote: post #95
Skates1616 wrote: post #42

Earlier quoted context omitted.

I’m very familiar with this space, specifically parenteral manufacturing. The real challenge lies in the expectations the FDA has set for manufacturing. Over time, the regulatory space has been heavily influenced by academic-driven theoretical scenarios for microbiological contamination. While well-intentioned, these theoretical risks often drive overly stringent requirements that don’t always reflect real-world manu…

https://www.propublica.org/article/fda-drug-loophole-sun-pha... > Digging through company records and test results, they found more evidence of quality problems, including how managers hadn’t properly investigated a series of complaints about foreign material, specks, spots and stains in tablets. > Those unknowns have done little to slow the exemptions. In 2022, FDA inspectors described a “cascade of failure” at one…

I think it can be both actually. The FDA through over regulation scared local manufacturing from generics which are generally low margin. Overtime you become dependent on Indian generics which have a horrible track record, this is a country that has massive lead contamination from spices and the government does nothing about it. Too late now the ship has sailed and you are now forced to utilize these. No doubt it’s a structural problem in the FDA but it can also be one where perhaps the stakes were kept too high for manufacturing in the US.

Re: The Collapse of the FDA

#113

Post by more_corn »

alejohausner wrote: post #49
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.

I’ve heard RFK say that it’s hard to ban TV ads for drugs. They are “speech” according to the 1st amendment, or something like that. Too bad. News broadcasts are full of those ads, and hence TV journalists are loath to investigate the people that pay their salaries.

The biggest war advertising ever won was manipulating us into classifying their manipulation as speech.

Convincing people to buy things they don’t want or need shouldn’t be protected speech. Convincing people to take medication they don’t need is the pinnacle of idiocratic capitalist absurdity.

Re: The Collapse of the FDA

#114

Post by ourmandave »

3D30497420 wrote: post #80
UltraSane wrote: post #77

The FDA's creation was directly triggered by multiple mass poisoning incidents in the early 1900s.In 1937 over 100 people died from diethylene glycol-contaminated medicine, leading to the 1938 Food, Drug, and Cosmetic Act that significantly expanded FDA authority.

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.

Like before his confirmation, when RFK wanted to Make Polio Great Again.

And Mitch McConnell, who suffered from polio when he was 2 years old back in 1944, had strong words, but confirmed the anti-vaccine halfwit anyway.

Good job Mitch!

Re: The Collapse of the FDA

#115

Post by temporallobe »

alejohausner wrote: post #49
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.

I’ve heard RFK say that it’s hard to ban TV ads for drugs. They are “speech” according to the 1st amendment, or something like that. Too bad. News broadcasts are full of those ads, and hence TV journalists are loath to investigate the people that pay their salaries.

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

Re: The Collapse of the FDA

#116

Post by alistairSH »

HenryBemis wrote: post #64
vel0city wrote: post #52

Earlier quoted context omitted.

There's loads of precedent pointing to commercial speech such as marketing as having some specific carve outs on the right to free speech. After all we have limits on tobacco marketing and food labeling requirements.

The politicians are getting funded/paid (lobbying/donations) by the very same people/companies that pay the ad revenue to those media. Why on earth would politicians legislate against their actual bosses? (As a real life reminder - a dog that bites the hand that feed him is put down). Courts btw don't make up shit.. they 'judge' (verb) with the criteria of 'what does the law define'. So if politicians legislate wisel…

They used to be paid of RJ Reynolds, etc as well.

The problem here is the drugs that are advertised as generally considered "good things". Anybody attempting to regulate the display of these ads would likely need to prove the ads are more harmful than any positive from the ads.

Re: The Collapse of the FDA

#117

Post by brookst »

temporallobe wrote: post #115
alejohausner wrote: post #49

Earlier quoted context omitted.

I’ve heard RFK say that it’s hard to ban TV ads for drugs. They are “speech” according to the 1st amendment, or something like that. Too bad. News broadcasts are full of those ads, and hence TV journalists are loath to investigate the people that pay their salaries.

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

TV ads for cigarettes are not legal in the US at least. And alcohol ads have a bunch of weird regulations like they can’t show people in the act of drinking (holding the booze is fine).

Re: The Collapse of the FDA

#118

Post by msgodel »

hinterlands wrote: post #11
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…

It's about EDTA. It can be legitimately used to treat heavy metal poisoning, plus some other things. Some people (who are probably misguided) want to self-medicate. The FDA won't let you. Hence, drama.

Not allowing self medication was probably a mistake.

Re: The Collapse of the FDA

#119

Post by msgodel »

jajko wrote: post #88
Tuna-Fish wrote: post #81

Earlier quoted context omitted.

EDTA removes all metals. It's simply a compound that forms water-soluble complexes with metal ions, removing them from the body. The way idiots kill their children with it is that among other metals, it removes calcium ions, and those are necessary for life, with low enough concentration in blood eventually resulting in cardiac arrest. So said idiots have an autistic child, read junk online that tells them that "toxi…

If you have such parents, you basically lost the game of life without having a chance to participate much. The only real solution would be to forcibly and permanently take children away from such people, not something I see flying in US if we don't include ie physical abuse or pedophilia. I feel like a basic human life value has decreased recently. Be it ongoing brutal wars, news pushing doom and gloom 24/7, covid ce…

Yeah this is one of those situations where people freak out about their neighbor's behavior and try to change who they are with administrative policy. It's really just counter productive.

I think better would be for people to be more personally picky who they share spaces with.

Re: The Collapse of the FDA

#120

Post by jghn »

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.

Also "medical device" is a broader term than most people realize. For instance: a blood draw or tissue biopsy, followed by DNA sequencing, followed by data analysis, leading to a report for personalized cancer treatment.
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