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The Collapse of the FDA

nytimes.com

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Re: The Collapse of the FDA

#61

Post by zer00eyz »

dmm wrote: post #9

Reading "Bottle of Lies" by Katherine Eban, I'd argue that the collapse of the FDA was well underway before the current administration. The FDA was completely unable to regulate overseas drug manufacturers, resulting in many, many problems. Sincere attempts to inspect overseas drug makers with random inspections universally results in shutdowns, which cause politically unpopular drug shortages, making enforcement pol…

Chiron: 2004, the UK government shut down their flu vax plant (it was in the UK). It later came out that the FDA knew what was up and basically let it slide. It was one of the early ani-vax movements torches... Crunchy moms pissed about shots for kids and parents on Oxycodone were not happy with Pharma (or corporations in general: Enron etc..)

> politically unpopular drug shortages ...

Ask your ADHD friends about how they get their meds.

One side wants to keep it, the other side wants to get rid of it. No one wants to fix the problem.

Re: The Collapse of the FDA

#62

Post by teepo »

cosmicgadget wrote: post #17
dmm wrote: post #9

Reading "Bottle of Lies" by Katherine Eban, I'd argue that the collapse of the FDA was well underway before the current administration. The FDA was completely unable to regulate overseas drug manufacturers, resulting in many, many problems. Sincere attempts to inspect overseas drug makers with random inspections universally results in shutdowns, which cause politically unpopular drug shortages, making enforcement pol…

That seems more like an "underfunded and underjurisdictioned" problem for a portion of what they do, rather than collapse of the agency.

It feels to me like the tyranny of small differences. The fact that the various watchdogs amplified such specific issues greatly overshadowed their support of the mission. From what I've read, the FDA is a backwater from a funding perspective, and yet a punching bag from a regulatory point-of-view.

  *He and his colleagues had also been engaged in a decades-long debate with a sprawling community of watchdogs — mostly doctors, lawyers and scientists from outside the agency — who were often broadly supportive of the agency’s mission but who fought with officials like Califf, sometimes bitterly, over the specifics: How should the F.D.A. be financed? What kind of evidence should new drugs and medical devices require? How should regulators weigh the concerns of industry against the needs of doctors, patients and consumers?*

Re: The Collapse of the FDA

#63

Post by TylerE »

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.

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

Re: The Collapse of the FDA

#64

Post by HenryBemis »

vel0city wrote: post #52
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.

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 wisely, courts will enforce any 'parliamentary' and/or executive order to ban the advertisements of medicine.

But they won't. Not until push-comes-to-shove, and the true bosses will reposition to 'the next thing' (smoking, sugary-foods, medicine) and then they will allow the politicians to finally block meds ads. In which case the 'next wave' will begin. Story as old as time...

Re: The Collapse of the FDA

#65

Post by aspenmayer »

zer00eyz wrote: post #61
dmm wrote: post #9

Reading "Bottle of Lies" by Katherine Eban, I'd argue that the collapse of the FDA was well underway before the current administration. The FDA was completely unable to regulate overseas drug manufacturers, resulting in many, many problems. Sincere attempts to inspect overseas drug makers with random inspections universally results in shutdowns, which cause politically unpopular drug shortages, making enforcement pol…

Chiron: 2004, the UK government shut down their flu vax plant (it was in the UK). It later came out that the FDA knew what was up and basically let it slide. It was one of the early ani-vax movements torches... Crunchy moms pissed about shots for kids and parents on Oxycodone were not happy with Pharma (or corporations in general: Enron etc..) > politically unpopular drug shortages ... Ask your ADHD friends about how…

> No one wants to fix the problem.

That’s not what wedge issues are for. They’re not meant to be solved, because then they’re used up, and there’s airtime to fill in the meantime.

Re: The Collapse of the FDA

#66

Post by grues-dinner »

Aloisius wrote: post #15
hinterlands wrote: post #11

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."

"Heavy metal" in general is a bad term, but especially when used as a proxy for toxin. There is no universal definition of heavy metal and there is no inherent connection to toxicity in any specific organism.

Then again, pretty much every metal is toxic at some relatively low body-mass concentration, even iron (which actually can and does kill people, especially when children eat adult iron supplements).

Even lovely unreactive gold does have compounds that are toxic.

Re: The Collapse of the FDA

#67

Post by const_cast »

monero-xmr wrote: post #34
sorcerer-mar wrote: post #31

Earlier quoted context omitted.

Anyone who has worked in drug development knows how vital FDA is. The FDA costs taxpayers less than $4 billion per year. If FDA is a net negative, next time you need a medication you're aware you can go participate in a Phase I study, and get paid to take a cutting edge drug for it? Why bother looking at the stuff on the medicine shelf that costs you money? Can you give us all an idea of your experience working with…

Should allow pharma to sell drugs to the market. Allow people to sue if they are harmed. Do not care about a government agency preventing access to new drugs. They can gatekeep government funds at best, limiting Medicaid / Medicare to those that want to pass their hoops My experience is in selling tech to government. Disgusting and corrupt.

> Should allow pharma to sell drugs to the market. Allow people to sue if they are harmed.

This is a comical extreme vision of libertarian politics. Everything gets worse, lots of people die, but it's okay because we have a small principle of freedom. Yeah. Great.

If you're trying to persuade people you're doing a very shit job.

Re: The Collapse of the FDA

#68

Post by const_cast »

SV_BubbleTime wrote: post #55
nine_zeros wrote: post #35

Earlier quoted context omitted.

> Government agencies that spend massive amounts of tax dollars while accomplishing nothing and being net-negative for society. Anyone who has worked for or dealt with the government for extended periods of time will clearly know how fucked it is This is only true of republican governments. Republican-led governments are truly appalling in their spending, and wasteful tax cuts. Democrat governments are far far more e…

[flagged]

BBB is the most recent example of this. We cut spending across the board, shit on American, and in exchange we... raised the deficit by Trillions of dollars? What? How?

Republican fiscal policy.

Re: The Collapse of the FDA

#69

Post by TFYS »

monero-xmr wrote: post #34
sorcerer-mar wrote: post #31

Earlier quoted context omitted.

Anyone who has worked in drug development knows how vital FDA is. The FDA costs taxpayers less than $4 billion per year. If FDA is a net negative, next time you need a medication you're aware you can go participate in a Phase I study, and get paid to take a cutting edge drug for it? Why bother looking at the stuff on the medicine shelf that costs you money? Can you give us all an idea of your experience working with…

Should allow pharma to sell drugs to the market. Allow people to sue if they are harmed. Do not care about a government agency preventing access to new drugs. They can gatekeep government funds at best, limiting Medicaid / Medicare to those that want to pass their hoops My experience is in selling tech to government. Disgusting and corrupt.

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 with its resources would guarantee that most abuses would go unpunished and suffering would certainly increase compared to an environment with well functioning FDA.

Re: The Collapse of the FDA

#70

Post by rwmj »

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.

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.
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