Poll of the Day > 1/3 of new drugs had safety problems after FDA approval.

(+) Yeah! (+)

https://www.npr.org/sections/health-shots/2017/05/09/527575055/one-third-of-new-drugs-had-safety-problems-after-fda-approval

This article is from a couple years ago but its crazy how many.

The Food and Drug Administration is under pressure from the Trump administration to approve drugs faster, but researchers at the Yale School of Medicine found that nearly a third of those approved from 2001 through 2010 had major safety issues years after the medications were made widely available to patients.
Seventy-one of the 222 drugs approved in the first decade of the millennium were withdrawn, required a "black box" warning on side effects or warranted a safety announcement about new risks, Dr. Joseph Ross, an associate professor of medicine at Yale School of Medicine, and colleagues reported in JAMA on Tuesday. The study included safety actions through Feb. 28.

Also note the articles bias even though its NPR by trying to spin it to blame Trump when they were talking about drugs approved from 2001-2010.

While the administration pushes for less regulation and faster approvals, those decisions have consequences," Ross says. The Yale researchers' previous studies concluded that the FDA approves drugs faster than its counterpart agency in Europe does and that the majority of pivotal trials in drug approvals involved fewer than 1,000 patients and lasted six months or less.
It took a median of 4.2 years after the drugs were approved for these safety concerns to come to light, the study found, and issues were more common among psychiatric drugs, biologic drugs, drugs that were granted "accelerated approval" and drugs that were approved near the regulatory deadline for approval.

Interesting how the left went from being concerned about drugs being approved too quickly to now. Maybe they somehow believe the FDA is doing a better job because Biden is in charge. lol.

Love the shifting goalposts. Never change!

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Jen0125 posted...

Love the shifting goalposts. Never change!

Umm what goalposts have been shifted? Are you just throwing out buzzwords now? I was just posting an article from NPR to help educate and enlighten other posters who arent close minded.

MartianManchild posted...

Umm what goalposts have been shifted? Are you just throwing out buzzwords now? I was just posting an article from NPR to help educate and enlighten other posters who arent close minded.

"We don't like it it's not FDA approved"
"It's FDA approved now"
"Well no one trusts the FDA!"

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It's not worth responding to this fucking shit gimmick, Jen. Anyone who isn't a dense as fuck moron knows what you mean by "shifting goalposts"

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Far-Queue posted...

It's not worth responding to this fucking shit gimmick, Jen. Anyone who isn't a dense as fuck moron knows what you mean by "shifting goalposts"

I know but there are always people out there that aren't in so deep that can read things

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Fighting the good fight

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Far-Queue posted...

Fighting the good fight

Adjl does it better because he's smarter than me

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I haven't trusted the FDA for over a decade.

Zantac was pulled from the market in 2020, after almost 40 years of use due to concerns that the API, ranitidine, causes cancer. Great job FDA.
https://www.health.harvard.edu/blog/popular-heartburn-drug-ranitidine-recalled-what-you-need-to-know-and-do-2019092817911

Anticholinergic drugs increase the risks of dementia in older patients. So safe FDA.
https://www.webmd.com/alzheimers/news/20190624/commonly-prescribed-meds-could-raise-dementia-risk

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SunWuKung420 posted...

I haven't trusted the FDA for over a decade.

Zantac was pulled from the market in 2020, after almost 40 years of use due to concerns that the API, ranitidine, causes cancer. Great job FDA.
https://www.health.harvard.edu/blog/popular-heartburn-drug-ranitidine-recalled-what-you-need-to-know-and-do-2019092817911

Anticholinergic drugs increase the risks of dementia in older patients. So safe FDA.
https://www.webmd.com/alzheimers/news/20190624/commonly-prescribed-meds-could-raise-dementia-risk

That's less the FDA being sloppy and untrustworthy and more a matter of it being completely impossible to assess the safety of any drug over the time periods seen there before releasing them. You simply cannot conduct decades-long longitudinal studies as part of clinical trials. That's not a remotely possible standard to uphold, so citing that as a failure of the FDA is absurd.

I also feel the need to break down some of the specific claims you're making:

SunWuKung420 posted...

due to concerns that the API, ranitidine, causes cancer.

Correction: Because it contains trace amounts of a compound that has been classified as a probable carcinogen because exposing animals to high doses over long periods of time causes cancer, though there have not been enough studies in humans to conclude much of anything. The very article you linked says that the products don't pose any immediate health risk. "Zantac causes cancer" is nothing more than knee-jerk fearmongering that grossly overstates the concerns at play in pulling it from the market.

SunWuKung420 posted...

Anticholinergic drugs increase the risks of dementia in older patients.

Specifically, a correlation (50% higher incidence) was observed between patients who had been prescribed strong anticholinergics and dementia. It is unclear whether this correlation was because the drugs actually increased the risk or because they were prescribed more frequently to treat symptoms associated with early stages of dementia. There was also no association at all found between use of weaker anticholinergics like Benadryl or GI treatments and dementia.

That one, ultimately, is just a risk factor for doctors to consider in prescribing the drugs, not something that should make everyone wary of them. Many of those drugs are prescribed to treat depression, Parkinson's, epilepsy, and other serious conditions that shouldn't be left untreated, so while it's important to make informed decisions about the risks involved with a given prescription and finding safer alternatives is a worthwhile goal, this also is not a matter of categorically saying "these are dangerous and nobody should take any of them." It's just another piece of the risk analysis.

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See? There he is. Doing it again.

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Jen0125 posted...

Love the shifting goalposts. Never change!

Can you try a little harder please. I hate that I have like 3/4 of the trolls on this board blocked. I love trolls! but you're all so bad at this

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why do people keep responding to this gimmick account seriously? Just ignore them and they'll go away...

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SunWuKung420 posted...

I haven't trusted the FDA for over a decade.

Zantac was pulled from the market in 2020, after almost 40 years of use due to concerns that the API, ranitidine, causes cancer. Great job FDA.
https://www.health.harvard.edu/blog/popular-heartburn-drug-ranitidine-recalled-what-you-need-to-know-and-do-2019092817911

Anticholinergic drugs increase the risks of dementia in older patients. So safe FDA.
https://www.webmd.com/alzheimers/news/20190624/commonly-prescribed-meds-could-raise-dementia-risk

Theres also studies that classify dairy as a carcinogen or at least that it correlates with increased cancer, but that never stopped you from making pizzas.

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It's weird that america even has commercials for drugs, the ones listing all the side effects.
Commercials for drugs are illegal in most other countries.
America is a very weird place that seems to ultimately be about money.

SunWuKung420 posted...

I haven't trusted the FDA for over a decade.

Zantac was pulled from the market in 2020, after almost 40 years of use due to concerns that the API, ranitidine, causes cancer. Great job FDA.
https://www.health.harvard.edu/blog/popular-heartburn-drug-ranitidine-recalled-what-you-need-to-know-and-do-2019092817911

I'd prefer they just give me a choice, there is no medicine that works as well as ranitidine does.

Jen0125 posted...

See? There he is. Doing it again.

Is what I do.

Kimbos_Egg posted...

why do people keep responding to this gimmick account seriously? Just ignore them and they'll go away...

Mostly to keep people from being misled. Obviously, TC's not remotely interested in learning more about the subject and realizing how wrong he is about pretty much everything, but until he actually stops spreading misinformation and misinterpreted conclusions, it's necessary to call him out on his nonsense to so readers who lack the scientific literacy to recognize his misinformation don't end up buying into it. As Jen pointed out, this is a blatant attempt to move the goalposts from "this vaccine isn't even approved it couldn't possibly be safe" to "sure it's approved, but the FDA makes mistakes all the time, so it still couldn't possibly be safe." Many people wouldn't notice that, and this would cause them to be more hesitant about getting the shot. TC is blatantly trying to undermine the only way the pandemic is ever going to get better, and it falls to those of us that realize that to make sure as few people as possible get sucked in.

Of particular note is the fact that the AZ/JJ blood clot issues and the Moderna/Pfizer myocarditis issues would both qualify as "safety problems after approval," had the corresponding vaccines been kept off the market until full FDA approval was granted. They would not have been found during the normal clinical trial process (though it is again important to note that the full clinical trial process was completed for these vaccines, the stages were just conducted in parallel to save time) due to their rarity (you can't detect 1-in-100,000 side effects with a sample population of under 10,000), so citing them as an example of regulatory oversight is unreasonable.

That "1/3 of new drugs" figure is not strictly limited to rare adverse effects like those (one of the most notorious examples would be Thalidomide, though obviously that's not an example from the period this study examined), but recognizing that they do make up a non-trivial part of it is an important piece of context in order to respond appropriately to this headline. There is ample room to call for more stringency in the FDA approval process, but that's not cause to distrust what they're saying about the Covid vaccines (especially where other regulatory agencies around the world have approved them with more stringent standards).

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kangolcone posted...

Theres also studies that classify dairy as a carcinogen or at least that it correlates with increased cancer, but that never stopped you from making pizzas.

Also bacon and red meat. Ethanol's carcinogenicity is also very well documented, especially for people that consume it regularly.

BlackScythe0 posted...

I'd prefer they just give me a choice, there is no medicine that works as well as ranitidine does.

By the sound of what they're saying there, I'd expect it back on the market within a year or two. Pulling it seems very much like a matter of "hold up maybe this causes cancer let's study it further before we keep selling it," but given the dosage, relative infrequency of use, and lack of conclusive carcinogenicity in humans, I doubt the final verdict will be to say that it's dangerous.

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adjl posted...

That's less the FDA being sloppy and untrustworthy

But, besides those particular challenges, the FDA is both sloppy and untrustworthy. The FDA has consistently failed to do its job on both fronts -- they failed to assess safety properly, and they blocked life-saving medication from going to market, killing many. Even worse, they initiated programs that gave rights to medications used for thousands of years -- things that cost basically nothing -- to drug companies who charged a small fortune, even when the testing program had no direct connection to what they were taking the rights for.

The entire organization needs to be gutted, and some of its leaders should be probably be criminally investigated to see how they may have profited from interactions with drug companies, etc.

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If you have concerns then whatever TC, that's your deal man but this ain't your audience. You're not going to get anything out of this exchange.

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The 2nd ammendment says you can shoot the virus with your germ guns

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Zeus posted...

But, besides those particular challenges, the FDA is both sloppy and untrustworthy. The FDA has consistently failed to do its job on both fronts -- they failed to assess safety properly, and they blocked life-saving medication from going to market, killing many. Even worse, they initiated programs that gave rights to medications used for thousands of years -- things that cost basically nothing -- to drug companies who charged a small fortune, even when the testing program had no direct connection to what they were taking the rights for.

The entire organization needs to be gutted, and some of its leaders should be probably be criminally investigated to see how they may have profited from interactions with drug companies, etc.

Oh yeah, there's plenty of room to criticize and improve the FDA. The US pharmaceutical industry is a hot, corrupt mess. The fact that post-approval issues arise isn't necessarily cause to distrust them, though. That's just the nature of trials: You're always going to have a more limited scope in trials than you see when the product hits shelves, no matter how hard you try. Establishing robust standards for how hard manufacturers have to try is still important, and the FDA's been eroding those standards for some time, but problems are always going to slip through.

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adjl is smart yeah but I think his greater strength is his immeasurable patience.

Lots of us can put up a decent argument, but speaking for myself here I'll eventually write off the morons for the morons they in fact are, and tell them as much with a few choice words peppered in depending on the level of stupidity of the person I'm arguing with.

adjl stays laying out facts all day long and I rarely see him get exasperated and resort to telling the other person to fuck right off with their bullshit

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Far-Queue posted...

I rarely see him get exasperated and resort to telling the other person to f*** right off with their bulls***

It happens occasionally, but generally only when the person really deserves it.

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Lol, adjl shilling for bad science, bureaucracy and corporate control is awesome.

Remember when alchemists thought liquid metal, aka mercury, was a cure-all.

Ethanol has saved more lives than it has ended.

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SunWuKung420 posted...

Ethanol has saved more lives than it has ended.

I agree with you, my fellow alcoholic. We cant let posters like adjl ruin your argument with stupid shit like facts or appropriately collected data.

SunWuKung420 posted...

Lol, adjl shilling for bad science, bureaucracy and corporate control is awesome.

Remember when alchemists thought liquid metal, aka mercury, was a cure-all.

Ethanol has saved more lives than it has ended.

you want to eat some horse paste don't you

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Cacciato posted...

I agree with you, my fellow alcoholic. We cant let posters like adjl ruin your argument with stupid shit like facts or appropriately collected data.

lmao

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SunWuKung420 posted...

Lol, adjl shilling for bad science, bureaucracy and corporate control is awesome.

I mean, if you feel you can correct anything specific I said, you're quite welcome to. Given that I literally used the sources you provided to debunk your knee-jerk reactions, though, you might struggle with that a bit. Otherwise, I really would not call "The US pharmaceutical industry is a hot, corrupt mess." "shilling" by any stretch of the imagination. But hey, if that's how you want to characterize anything that isn't an oversimplified "FDA bad nature good" sort of mentality instead of actually thinking about the issue and forming a better-reasoned response, I guess that's your prerogative.

SunWuKung420 posted...

Ethanol has saved more lives than it has ended.

Not in the quantities many people (including yourself) consume it today. Even then, during the period when it was saving lives en masse (that is, pretty much the entirety of human history up until we figured out how to sterilize water without brewing something in it), life expectancies were low enough that being exposed to carcinogens often didn't have much chance to have an effect (and if it did, nobody identified it as cancer). It is an undeniable, well-documented fact that ethanol is a carcinogen. Most people that drink in reasonable moderation will never have to worry about developing cancer from it, but that's true of every toxin: Dosage (plus exposure route) is everything.

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Goddammit, there he fucking goes again. Unbelievable. Sunny wont stand for this and the way you treat us alcoholics.

@Cacciato we are not the same, other than both of us being human. Well, I am. It's unclear about you.

@adjl So 100 years of failed human science trumps (no pun intended) over 10,000 years of successful human existence? Keep on shilling, I'll be chilling.

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SunWuKung420 posted...

@Cacciato we are not the same, other than both of us being human. Well, I am. It's unclear about you.

@adjl So 100 years of failed human science trumps (no pun intended) over 10,000 years of successful human existence? Keep on shilling, I'll be chilling.

Thats the spirit, my alcohol-fueled compatriot. Fight the good fight! Make your garbage rhymes and enjoy the fun.

SunWuKung420 posted...

@adjl So 100 years of failed human science trumps (no pun intended) over 10,000 years of successful human existence? Keep on shilling, I'll be chilling.

Are you actually trying to make the claim that ethanol isn't carcinogenic?

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I mean they okayed aspartame, so that says just about everything you need to know.

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