Live data from Hacker News

The Collapse of the FDA

nytimes.com

81–90 of 220 posts

Re: The Collapse of the FDA

#81

Earlier quoted context omitted.

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.

Iron, copper, zinc, cobalt, manganese and selenium are "heavy metals."

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 "toxins" caused this, find the compound that is legitimately used to remove toxins, and administer enough to end the autism. By stopping their child's heart.

I don't particularly like the FDA, but restricting the availability of EDTA is not something I'd criticize.

Re: The Collapse of the FDA

#82

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 someone to point out that all we need is perfect regulation that exactly lets through all the good ones and filters all the bad ones....

Re: The Collapse of the FDA

#83
post #63

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.

They were illegal up until quasi recently… mid 90s IIRC. I believe it was right around the time of Viagra - probably not a coincidence.

Close, 1982 for print, 1983 for TV. You’re thinking of Rogaine, I think.

https://en.wikipedia.org/wiki/Direct-to-consumer_advertising

> Merck published the first print DTC ad for a pneumonia vaccine targeting those aged 65 years and older, and Boots Pharmaceuticals aired the first DTC television commercial in 1983 for the prescription ibuprofen Rufen.

But that sentence was worded weirdly, so I checked the sources. This is one of the two for that part:

https://web.archive.org/web/20250114005757/https://adage.com...

> While 2006 marks the 10-year anniversary of the Claritin ad, it was actually 24 years ago that the FDA unwittingly opened the door to DTC. Speaking at the American Advertising Federation conference and addressing the Pharmaceutical Advertising Council, then-FDA Commissioner Arthur Hull Hayes Jr. summarized the state of drug advertising, saying it "may be on the brink of the exponential-growth phase of direct-to-consumer promotion of prescription products."

> Drug companies jumped on the phrase "exponential growth" and took it to mean the FDA, however tacitly, supported DTC.

> 'Opening a closed door'

> "It was viewed by the industry as FDA opening a closed door," said Kenneth R. Feather, a former associate FDA commissioner.

> A year later, in 1983, Boots Pharmaceuticals aired the first direct-to-consumer TV ad when it promoted its prescription ibuprofen medication, Rufen. The company also ran newspaper ads at the same time. That was in May; by September, the FDA asked the industry for a voluntary moratorium on drug advertisements. (Ibuprofen actually went over the counter a year later.)

> In 1984, Upjohn sponsored a major conference on DTC advertising in Washington, D.C., where it made no bones about expressing its opposition to the practice. But less than five years later, Upjohn was touting the merits of DTC after its hair-restoration medication, Rogaine, was approved by the FDA and needed to be marketed.

Re: The Collapse of the FDA

#84
post #82

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…

I will go further. In the snake oil market, trying to produce actually good novel drugs is a loosing strategy. You wont be selling more, because you will have exactly the same footing as those who just lie and exaggerate over their results. Except they will have more funds to spread those lies and to convince people, because they did not wasted money on research.

Re: The Collapse of the FDA

#85
post #78

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.

I wonder if it would be possible to ban visuals on these ads. To allow only text.

[deleted]

Re: The Collapse of the FDA

#86

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 prescribed by doctors, and the whole industry setup to encourage prescription, I think thats not really true. Its not even like its that effective as a pain relief (https://www.bjanaesthesia.org/article/S0007-0912(17)37428-7/...)

Re: The Collapse of the FDA

#87
post #73

Reject modernity. Return to the old ways Pity the old ways are > You’ve died of dysentery

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.

Re: The Collapse of the FDA

#88

Earlier quoted context omitted.

Iron, copper, zinc, cobalt, manganese and selenium are "heavy metals."

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 certainly didnt help or something similar. A bit like reversal to medieval times when cruel public executions were a spectacle for whole town and families and life of individual was truly worthless.

If thats the case, let the dumb die including offsprings, just don't let their bills to be picked up by society. Extremely cruel, but it seems we are heading that way, and we have this little thing called overpopulation. Extreme freedom with extreme consequences.

Re: The Collapse of the FDA

#89
post #70

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.

It was a very strange experience once when I was in the US, at a hotel reception, suddenly hearing an advert for a sildenafil drug on TV behind the receptionist.

"Didn't you have ads in the 20th century?"

https://www.youtube.com/watch?v=XPGgTy5YJ-g

Re: The Collapse of the FDA

#90
post #73

Reject modernity. Return to the old ways Pity the old ways are > You’ve died of dysentery

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.

Well. There is measles epidemic right now...
Post reply on HN