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The Collapse of the FDA

nytimes.com

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Re: The Collapse of the FDA

#131

Post by roenxi »

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.

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 nimbleness and low costs is a much better path to take rather than optimising for something that is presented as a statistical rounding error.

If people don't think a drug manufacturer is safe they don't have to buy drugs from them.

Re: The Collapse of the FDA

#132

Post by [deleted] »

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…

[deleted]

Re: The Collapse of the FDA

#133

Post by api »

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.

My concern is that today this could happen and people wouldn’t care. Peoples cultlike ideologies, political tribalism, and belief systems are more important to them. There was a father whose child died of measles in Texas who continues to be anti vax.

Re: The Collapse of the FDA

#134

Post by bayarearefugee »

Amezarak wrote: post #91
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 don't think any convincing is needed. https://x.com/RobertKennedyJr/status/1793144103800361050 > We are one of only two countries in the world that allow pharmaceutical companies to advertise directly to consumers on television. Not surprisingly, Americans consume more pharmaceutical products than anyone else on the planet. > As I told @JoePolish, on my first day in office I will issue an executive order banning ph…

> Unfortunately, this is probably illegal.

Since when has something being illegal/unconstitutional stopped the current administration from doing anything?

So its still a choice they are making, just one that further shows that with the current administration (and ultimately SCOTUS with their shadow docket bullshittery) the rights of corporations are protected far more than the rights of individuals.

Re: The Collapse of the FDA

#135

Post by TFYS »

monero-xmr wrote: post #125
TFYS wrote: post #69

Earlier quoted context omitted.

Insanity. Do you honestly believe the average person (probably a sick one at that) has the resources and time to fight a large pharmaceutical company in court? And do you really believe that during the time between releasing the drug and losing in court the faulty drug wouldn't make the company much more money than they'd have to pay as compensation? The amount of organization it would require to beat a large company…

All of that still happens even with the FDA approving drugs. Luckily we have class action process

Not to the same extent, and the solution to that is to improve the FDA, not to demolish it and let companies poison and fool people freely.

Class action is what I meant with the difficulty of organizing. To make a class action happen and win, the damage done must be massive enough to get enough people to notice it and take action, and must be easily and cheaply provable. A class action is not going to fund expensive scientific studies that prove their problem was caused by the company they're suing. Your solution would only prevent the absolute worst cases. Any damage that's rare, hard to notice or prove, small, long term, etc would not get compensated and would cost society much more than properly funding FDA.

Re: The Collapse of the FDA

#136

Post by paul_milovanov »

Vinay Prasad, the new FDA chief medical and scientific director, is an extremely sensible guy and a co-author of a great 2013 book on evidence-based medicine targeting the lay audience (Ending Medical Reversal)

Here's an EconTalk podcast with the other co-author, Adam Cifu, talking about the book. https://www.econtalk.org/adam-cifu-on-ending-medical-reversa...

The NYT article presents his COVID vaccine policy changes as yet more crazy MAGA shit, whereas in fact he holds nuanced views, based on up-to-date review of available evidence. He has published in NEJM and elsewhere on the topic:

https://www.nejm.org/doi/full/10.1056/NEJMsb2506929

A short take on the above from Adam Cifu, whom I respect greatly: https://www.sensible-med.com/p/prasad-makary-and-an-evidence...

With all of that, I suspect that the rumours of FDA's death are greatly exaggerated.

Re: The Collapse of the FDA

#137

Post by tehwebguy »

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!

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

Re: The Collapse of the FDA

#138

Post by chasd00 »

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 about but here we are.

Re: The Collapse of the FDA

#139

Post by jrs235 »

bayarearefugee wrote: post #134
Amezarak wrote: post #91

Earlier quoted context omitted.

I don't think any convincing is needed. https://x.com/RobertKennedyJr/status/1793144103800361050 > We are one of only two countries in the world that allow pharmaceutical companies to advertise directly to consumers on television. Not surprisingly, Americans consume more pharmaceutical products than anyone else on the planet. > As I told @JoePolish, on my first day in office I will issue an executive order banning ph…

> Unfortunately, this is probably illegal. Since when has something being illegal/unconstitutional stopped the current administration from doing anything? So its still a choice they are making, just one that further shows that with the current administration (and ultimately SCOTUS with their shadow docket bullshittery) the rights of corporations are protected far more than the rights of individuals.

Every dollar needs equal representation.

P.S. I don't subscribe to the above but I believe it's where the owned government officials are at.

Re: The Collapse of the FDA

#140

Post by sorcerer-mar »

monero-xmr wrote: post #126
sorcerer-mar wrote: post #108

Earlier quoted context omitted.

Tell me: how do you prove that a drug hurt you? Spoiler alert: you cannot. The reason clinical trials are so expensive and complicated is because it's extremely hard to isolate signal of "what is this drug doing to people." So on what basis would you possibly sue a company? As another commenter said, we have an entire industry of the form you desire: supplements. Go take them to treat your next illness so you can rea…

Insurance companies will not cover ineffective drugs. Pharma will have to prove efficacy. Allow free people to spend their own money how they want

What incentive does an insurance company with an expected coverage period of 4 years have to prevent a drug with long term harm from reaching its patients?

What about drugs that people do not buy via insurance? Just have a free for all there?

Why wouldn't pharma just release the drug to the public at very low cost to use the unwitting public as its test subjects instead of running trials to satisfy insurance companies? If a bunch of people die then welp, you know not to pursue "insurance approval?"

Can't see how we could go wrong by making it very difficult to sell a working, expensive drug, and make it extremely cheap to sell a mass-market ineffective/unsafe drug...

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