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The Collapse of the FDA

nytimes.com

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Re: The Collapse of the FDA

#171

Post by Xss3 »

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.

There are serious cyber security implications too.

A recent discovery was a heart rate monitor used in hospitals that sent all data, including full patient details, to Chinese servers, and would accept arbitrary code updates from said servers.

If you wanted to kill a diplomat, muting or spoofing heart rate data while they have a cardiac event in hospital would be a very sneaky way to do it.

Re: The Collapse of the FDA

#172

Post by CleaveIt2Beaver »

jaredhallen wrote: post #153
bayarearefugee wrote: post #134

Earlier quoted context omitted.

> 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.

We get it, all lives matter.

The point they're making is that $currentAdministration ran specifically on a platform countering this behavior and have failed to keep those promises, whereas others which ignored it simply did not mention it.

Re: The Collapse of the FDA

#173

Post by terminalshort »

os2warpman wrote: post #165
terminalshort wrote: post #155

Earlier quoted context omitted.

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.

I was going to say "The FDA, in general, does not tell you which medications you can or cannot take." but often when people make a comment like yours and you press them on it, it turns out they're angry because they can't find a doctor who will inject something insane into an unusual part of their body so instead I am going to ask: What medicine, SPECIFICALLY PLEASE, does the FDA not allow you to have? edit: because…

Good question. I have narcolepsy. There is a medication called TAK-861 which is the first drug to actually treat the root cause of the disease. It has passed phase 1 and 2 trials proving it is safe and effective. My doctor is involved in the research has said he wishes he could prescribe it to me now, but it is still in phase 3 trials and will not be approved by the FDA for another 2 years, so he can't give it to me.

I despise nothing more than these bureaucrats. If I want to take the risk on a new medication then that's my choice. If someone else doesn't then that's fine too. I'm not the one telling other people what to do, these worthless busybody bureaucrats are.

Re: The Collapse of the FDA

#174

Post by UltraSane »

JKCalhoun wrote: post #151
api wrote: 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…

Fox News has been brainwashing people for a very long time now.

Re: The Collapse of the FDA

#175

Post by curt15 »

terminalshort wrote: post #173
os2warpman wrote: post #165

Earlier quoted context omitted.

I was going to say "The FDA, in general, does not tell you which medications you can or cannot take." but often when people make a comment like yours and you press them on it, it turns out they're angry because they can't find a doctor who will inject something insane into an unusual part of their body so instead I am going to ask: What medicine, SPECIFICALLY PLEASE, does the FDA not allow you to have? edit: because…

Good question. I have narcolepsy. There is a medication called TAK-861 which is the first drug to actually treat the root cause of the disease. It has passed phase 1 and 2 trials proving it is safe and effective. My doctor is involved in the research has said he wishes he could prescribe it to me now, but it is still in phase 3 trials and will not be approved by the FDA for another 2 years, so he can't give it to me.…

>I despise nothing more than these bureaucrats. If I want to take the risk on a new medication then that's my choice.

Are there laws that would indemnify the healthcare provider for unexpected adverse outcomes for voluntary recipients of experimental drugs?

Re: The Collapse of the FDA

#176

Post by morgannewman »

roenxi wrote: post #131
3D30497420 wrote: post #80

Earlier quoted context omitted.

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 n…

[dead]

Re: The Collapse of the FDA

#177

Post by s1artibartfast »

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…

This all seems entirely reasonable. This is a cost benefit calculation. If bad drugs kill 1 person, and drug shortage kills 100, what do you choose?

The FDA chose a practical middle ground. Ban what isn't critical, and for those that are, they put additional mitigations in place:

> Exempted drugs were sent to the United States in a “phased manner,” the company said, with third-party oversight and safety testing.

>“The odds of these drugs actually not being safe or effective is tiny because of the safeguards,” said one former FDA official involved in the exemptions who declined to be named because he still works in the industry and fears professional retribution. “Even though the facility sucks, it’s getting tested more often and it’s having independent eyes on it.”

Re: The Collapse of the FDA

#178

Post by Amezarak »

s1artibartfast wrote: post #177
Amezarak wrote: post #95

Earlier quoted context omitted.

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…

This all seems entirely reasonable. This is a cost benefit calculation. If bad drugs kill 1 person, and drug shortage kills 100, what do you choose? The FDA chose a practical middle ground. Ban what isn't critical, and for those that are, they put additional mitigations in place: > Exempted drugs were sent to the United States in a “phased manner,” the company said, with third-party oversight and safety testing. >“Th…

Then they should have been transparent about it.

Re: The Collapse of the FDA

#179

Post by terminalshort »

curt15 wrote: post #175
terminalshort wrote: post #173

Earlier quoted context omitted.

Good question. I have narcolepsy. There is a medication called TAK-861 which is the first drug to actually treat the root cause of the disease. It has passed phase 1 and 2 trials proving it is safe and effective. My doctor is involved in the research has said he wishes he could prescribe it to me now, but it is still in phase 3 trials and will not be approved by the FDA for another 2 years, so he can't give it to me.…

>I despise nothing more than these bureaucrats. If I want to take the risk on a new medication then that's my choice. Are there laws that would indemnify the healthcare provider for unexpected adverse outcomes for voluntary recipients of experimental drugs?

I don't know. I doubt it. This points to a fundamental problem in our liability system that there is no simple "This is my choice and there is nobody to blame but me. I take all the risk and can't sue anybody" contract. Our laws are written by lawyers for lawyers.

Re: The Collapse of the FDA

#180

Post by os2warpman »

terminalshort wrote: post #173
os2warpman wrote: post #165

Earlier quoted context omitted.

I was going to say "The FDA, in general, does not tell you which medications you can or cannot take." but often when people make a comment like yours and you press them on it, it turns out they're angry because they can't find a doctor who will inject something insane into an unusual part of their body so instead I am going to ask: What medicine, SPECIFICALLY PLEASE, does the FDA not allow you to have? edit: because…

Good question. I have narcolepsy. There is a medication called TAK-861 which is the first drug to actually treat the root cause of the disease. It has passed phase 1 and 2 trials proving it is safe and effective. My doctor is involved in the research has said he wishes he could prescribe it to me now, but it is still in phase 3 trials and will not be approved by the FDA for another 2 years, so he can't give it to me.…

>will not be approved by the FDA for another 2 years, so he can't give it to me.

edit: I wrote a bunch of bullshit and then deleted it but the points are:

1. Narcolepsy sucks

2. The FDA can't stop your doctor from giving you TAK-861, the likely culprit is Takeda. It is 100% legal for Takeda to sell Oveporexton so long as they don't claim that it treats narcolepsy until it has been approved, and it is 100% legal for your doctor to give it to you.

3. Have you looked at >>>RIGHT TO TRYhttps://www.fda.gov/patients/learn-about-expanded-access-and...

I know nobody believes me.

Here's an ambulance chaser's blog:

>Unapproved drugs exist in a gray area in U.S. law. Although it is not illegal to prescribe non-FDA approved drugs, it is also not viewed as best practice. If a doctor prescribes an unapproved drug, he or she could face civil liability for the patient’s injuries, illnesses, side effects or death upon taking the drug if the physician reasonably should have known of the potential health risks due to the lack of FDA approval.

https://www.liljegrenlaw.com/can-my-doctor-prescribe-non-fda...

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