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The Collapse of the FDA

nytimes.com

151–160 of 220 posts

Re: The Collapse of the FDA

#151
post #133

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.

> cultlike ideologies, political tribalism

It didn't use to be like this. I've considered a number of things in our society that I could point a finger at as the cause but often when I dig just a little below the surface the one thing that I always seem to uncover in all cases is fear.

How did we (U.S.) become such a fearful country? The pace of change? A media narrative? Starting with cable television and 24-hour news?

Re: The Collapse of the FDA

#152
post #133

Earlier quoted context omitted.

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.

> cultlike ideologies, political tribalism It didn't use to be like this. I've considered a number of things in our society that I could point a finger at as the cause but often when I dig just a little below the surface the one thing that I always seem to uncover in all cases is fear. How did we (U.S.) become such a fearful country? The pace of change? A media narrative? Starting with cable television and 24-hour ne…

The US became a fearful (and hateful) country because of the media, both traditional and tech/social.

Fear, hate, and other base emotions maximize engagement. A negative story that inspires fear or hate will get often thousands of times more clicks than a neutral or positive one. Media tends to be ad supported and run on attention maximizing KPIs, therefore the media pushes fear and hate.

Social media added a layer of personalized algorithm-driven amplification that dialed this way up, which is why politics has become hyper-polarized and dominated by insane narratives. It drives engagement.

Edit: the reason for this is probably an evolutionary bias toward negativity and paranoia. As the saying goes: If your ancestor mistook a bush for a lion, they lived. If your ancestor mistook a lion for a bush, they are not your ancestor. We are all the descendants of paranoids. Negative media pushes that button.

Re: The Collapse of the FDA

#153

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.

> current administration

Or previous ones.

Re: The Collapse of the FDA

#154

Earlier quoted context omitted.

"We do our peers, countrymen, students, and children a grave disservice by admonishing them to think for themselves without also giving them the critical thinking tools to do so, for in so doing we foster a culture where "independent thought" is equated with "contrarian thought". This gives rise to an anti-intellectual, anti-science paradigm that supports an idea not because it meets a basic standard of evidence, but…

Excellent statement, but who is the "great man" who once said this?

To tell the truth, I don't remember. I've kept a "quotes.txt" file for the last two or three decades where I paste in anything I feel is worth remembering. It's been in there as long as I can remember, but I apparently didn't bother with a proper attribution.

I want to guess Oliver Wendell Holmes for some reason, but it doesn't read like something he said. Sorry I can't be more helpful.

Re: The Collapse of the FDA

#155

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.

And if they had stuck with making sure medicine sold is exactly what it says on the bottle instead of expanding to telling me which medications I am allowed to have, I would be their biggest supporter.

Re: The Collapse of the FDA

#156

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…

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.

Re: The Collapse of the FDA

#157

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…

> 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 think that the FDA in practice exhibited dysfunctional characteristics in markets? With the longevity of the players and the deep pockets associated with health care, is it a stretch to see large changes to the institution as constructive in the long-run?

Re: The Collapse of the FDA

#158

Earlier quoted context omitted.

Excellent statement, but who is the "great man" who once said this?

To tell the truth, I don't remember. I've kept a "quotes.txt" file for the last two or three decades where I paste in anything I feel is worth remembering. It's been in there as long as I can remember, but I apparently didn't bother with a proper attribution. I want to guess Oliver Wendell Holmes for some reason, but it doesn't read like something he said. Sorry I can't be more helpful.

I don't know who said the above, but the following is from Isaac Asimov:

"Anti-intellectualism has been a constant thread winding its way through our political and cultural life, nurtured by the false notion that democracy means 'my ignorance is just as good as your knowledge'"[0]

[0] https://www.goodreads.com/quotes/84250-anti-intellectualism-...

Re: The Collapse of the FDA

#159

Earlier quoted context omitted.

Excellent statement, but who is the "great man" who once said this?

To tell the truth, I don't remember. I've kept a "quotes.txt" file for the last two or three decades where I paste in anything I feel is worth remembering. It's been in there as long as I can remember, but I apparently didn't bother with a proper attribution. I want to guess Oliver Wendell Holmes for some reason, but it doesn't read like something he said. Sorry I can't be more helpful.

And I'd add that as Peter Medawar correctly pointed out[0][1]:

"The USA is so enormous, and so numerous are its schools, colleges and religious seminaries, many devoted to special religious beliefs ranging from the unorthodox to the dotty, that we can hardly wonder at its yielding a more bounteous harvest of gobbledygook than the rest of the world put together."

[0] https://www.azquotes.com/quote/1064507

[1] As a middle-aged American who's lived their whole life in the US, this quote is spot on.

Re: The Collapse of the FDA

#160

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…

It can be true that not every function of the FDA works as intended, while it still does provide functions that are crucial to American society and are being removed.
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