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D
Deleted member 1159
Unconfirmed Member
Google “FDA user fees” and you can see exactly what companies pay for a review. I just paid them ~12k last week for a 510(k) review, which is completely public info. You don’t know what you’re talking about.
Also, if you want to know what’s a complete racket/black box, try finding out what it costs to get a CE mark in the EU. It’s a lot more than FDA gets paid and notified bodies aren’t even government entities
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Nobody_Important
“Aww, it’s so...average,” she said to him in a cold brick of passion
That is complete tinfoil nonsense. It's gone through the same process as everything else. The only difference is that it went faster for obvious reasons. As
EviLore
pointed out a few pages ago there have been over a billion doses administered to great effect in countries all around the globe. There have been no major issues despite billions of doses being given out in such a short period of time. In fact it has been the opposite. The vaccine has been shown by every objective measure to be a success against this virus. The vaccinated have a lower number of cases, lower number of hospitalizations, and a lower number of deaths compared to the non-vaccinated. This has been shown time and time again from data taken from across the globe.- The vaccine works
- The vaccine is safe
- The vaccine is approved by the FDA
- The vaccine is readily available
- The vaccine is free
Those are all indisputable facts no matter how much you wish it were different. No matter how much it flies in the face of whatever nonsense you keep trying to push despite the obvious. You can sit and argue about how the vaccine is implemented and you can argue about whether or not it should be required. But you can no longer question the safety of vaccine or its effectiveness compared to not taking it at all. The FDA has given its approval and no matter how distorted your view of reality is on this subject you should still be smart enough to know that the FDA is not going to approve something based purely on politics. The same goes for your absurd suspicion of the CDC. It is their freaking job to keep track of this stuff and to act accordingly. It is their job to keep the public safe and informed. Situations like this is literally why they exist in the first place. They are not going to magically turn into a purely political organization over the course of less than two years. Moreso than that just like the FDA they are not going to turn a blind eye to possible dangers regarding Covid, its variants, or the vaccines against it just because "poltics".
Your line of thinking may have had a good deal of merit when all this began, but that time has passed. The reality of the situation does not lie. Any attempt to try and paint the vaccine as being dangerous or ineffective at this point and you are just talking nonsense that flies in the face of reality. It's not the FDA or the CDC that is making it political at this point. It's just people like you.
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Thesuffering79
Banned
That is what is set, but pharma can pay more to get ahead of the queue and some other things. As i said those fees arent set in stone.
As a user of quite a few antipsychotic medicines, I can't believe many of them got past FDA approval. Which is why i have been questioning the FDA for a while now.
FDA at a Glance
FDA at a Glance is published annually by FDA’s Office of Economics and Analysis (OEA).OEA’s mission is to provide public health, economic, and strategic analysis and evaluation to inform FDA’s policy and rulemaking decisions.
So stuff like FDA approval for tobacco is 100% user fees.
Human drugs is 65% user fees.
Leads a lot to corruption.
D
Deleted member 1159
Unconfirmed Member
EU approvals are 100% user fees and the EU regs are insanely draconian/more difficult. I’ve never once seen anything remotely close to leveraging the user fees for reviews as some sort of bargaining chip for clearance or approval. This is literally my job, I literally pay these fees, I literally submit these things and have to negotiate with reviewers in the US and out. Not once has there ever been a hint of trying to buy someone off. Nobody wants to go to jail to meet a deadlineThat is what is set, but pharma can pay more to get ahead of the queue and some other things. As i said those fees arent set in stone.
As a user of quite a few antipsychotic medicines, I can't believe many of them got past FDA approval. Which is why i have been questioning the FDA for a while now.
FDA at a Glance
FDA at a Glance is published annually by FDA’s Office of Economics and Analysis (OEA).OEA’s mission is to provide public health, economic, and strategic analysis and evaluation to inform FDA’s policy and rulemaking decisions.www.fda.gov
So stuff like FDA approval for tobacco is 100% user fees.
Human drugs is 65% user fees.
Leads a lot to corruption.
Thesuffering79
Banned
How do i know what you are saying is true though? For all i know you could be lying through your teeth.
For the record I know the vaccines are relatively safe but i have used many medicines that nearly killed me that were approved by the FDA. So you can understand why I am skeptical that the FDA is not corrupt.
pel1300
Member
Here in Brazil it seems that some people have forgotten that there is still an extremely contagious variant circulating. Currently only 25.92% of the population is fully immunized.
This weekend people crowded the beaches due to the high temperatures of the last few days.
The beach on a hot sunny day where you absorb vitamin D while getting exercise (swimming, surfing, volleyball). One of the one of the best places to be - Bill Maher mentioned that it's absurd beaches were targeted as super spreaders.
Also, the idea that you could get the most social and outgoing, people like those in Rio De Janeiro to keep up with not socializing 18 months later is insane.
It's the same here in Mexico - Cancun, Playa Del Carmen, Puerto Vallarta. The beaches have been crowded for over a year now.
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Nobody_Important
“Aww, it’s so...average,” she said to him in a cold brick of passion
Just a mess waiting to happen.Here in Brazil it seems that some people have forgotten that there is still an extremely contagious variant circulating. Currently only 25.92% of the population is fully immunized.
This weekend people crowded the beaches due to the high temperatures of the last few days.
D
Deleted member 1159
Unconfirmed Member
You don’t know what I’m saying is true, but I seem to have an awful lot of specific knowledge and chime in about this one subject and not working oil fields or whatever. And like I said, if you take two seconds to google FDA user fees, you can see exactly what they are.
Pharmaceuticals aren’t a one-size-fits-all solution for everyone, which is why they’re prescribed by order of a physician only. Just because they’re approved, doesn’t mean they’re for everyone. What that means is when used under the care of a physician, the benefits have been shown to outweigh the risks. FDA doesn’t regulate the practice of medicine, however. A doctor can still prescribe the wrong drug to the wrong person or one that has known interactions to someone who might be vulnerable to that by mistake. That doesn’t mean FDA is corrupt (or not).
As vaccination rates approach strong majority thresholds in countries their economic and social tendencies will become means to increase vaccination.
In other words, the majority will see the solution to the threat and there's less patience and time(due to wanting to return to normal without threatening healthcare) to deal with reluctant individuals and holding their hands through their difficulties. There are limited resources for both personal and professional effort to guide the hesitant. There isn't unlimited altruism.
Businesses start mandating, people on the street vent their frustration.
Nobody_Important
“Aww, it’s so...average,” she said to him in a cold brick of passion
Medicines having bad side effects and still getting approved is not proof the FDA is "corrupt". Literally every other medicine on the market has some kind of risks associated with it, but it gets approval because the risk is minimal.
That is not a sign of corruption. That is a sign of extensive testing and statistics.
Thesuffering79
Banned
I already did google the user fees, that is where the graphs came from. I dont know if they vary. Like can an entity pay more for approval, is that at all possible? Can someone take money under the table?
Thesuffering79
Banned
Then if there is a risk at all, if a person is uncomfortable with the risks even though they are minimal, shouldn't they be allowed to not take the drug without being punished for it?
DeepBreath87
Banned
The most fun kind of mess, actually. Have fun not going to the beach though. I just got back a week ago. It was great. Perfect weather, jet skis, the ocean was great. Wouldn’t have missed it.
Nobody_Important
“Aww, it’s so...average,” she said to him in a cold brick of passion
Don't get me wrong on a normal summer I would love to head to the lake, pool, or beach if its available. But I'm not taking that kind of risk these days. It's not worth it.
DeepBreath87
Banned
To each their own. Covid isn’t going anywhere. Assuming you are vaccinated and not elderly, the risk is very very low. You take risks every day just getting in the car to go leave your house. If you’re going to let the risks of covid stop you from enjoying your life at this point, I think that’s actually quite sad.
Nobody_Important
“Aww, it’s so...average,” she said to him in a cold brick of passion
You are right I do take risks getting in the car. That's why I wear a seatbelt. It a basic safety precaution just like social distancing and vaccination. I also NEED to get in my car. I don't NEED to go to the pool.
From my perspective I think its sad that ignorant people refuse to get vaccinated so that I can feel better about going to the pool. But hey "to each their own" right?
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It's difficult to tell in that image if people aren't somewhat well spaced and bubbled. It doesn't look that bad. It's not Lollapalooza crowded.Here in Brazil it seems that some people have forgotten that there is still an extremely contagious variant circulating. Currently only 25.92% of the population is fully immunized.
This weekend people crowded the beaches due to the high temperatures of the last few days.
Advice we got here was that Covid doesn't transmit well outdoors. Still can get it, just reduced chances. Go outside and have fun, just don't bunch up. Looks like Delta's outdoor transmission is still being studied.
DeepBreath87
Banned
The vaccine will protect you just fine. More than enough for you to go to a pool for Christ’s sake. Your reluctance to do so is entirely on you. For someone who loves to tout the vaccine and the authorities who vouch for it, you don’t seem to be acting like you believe the things you say you do. Hell, our actions would say I believe in the vaccine more than you do.
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Nobody_Important
“Aww, it’s so...average,” she said to him in a cold brick of passion
I 100% trust the vaccine to help me, but I'm not a moron. If the vaccine was 100% effective I would be at the pool right now. No joke. But it's not. So I don't take unnecessary risks. Plus since I am in the "great" state of Texas we have some problems down here regarding Covid in case you haven't heard. Especially when it comes to willingness to abide by suggested safety precautions. If I was in a state that actually cared and was properly run then I would feel way safer about getting out like that, but its just not worth it. I have a jacuzzi in the back and I can turn the heat off if I want a relaxing soak. It's not that big of a deal.
It all comes down to how badly I wanna go to the pool, go out to the bars, or the theater despite the circumstances no matter how minimal the risk. The answer is "not enough".
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pel1300
Member
BBC article on natural immunity vs vaccination:
www.bbc.com
It talks about antibodies and memory T-cells. Surprised the BBC allowed this to be published.
Covid: What’s the best way to top up our immunity? - BBC News
Now we have some protection, do we need to keep boosting or can nature take its course?
www.bbc.com
It talks about antibodies and memory T-cells. Surprised the BBC allowed this to be published.
Nobody_Important
“Aww, it’s so...average,” she said to him in a cold brick of passion
And yeah I know it is the smallest of risks, but I take care of my grandparents and their shopping/errands on the weekends. So even if the odds are overwhelmingly in my favor I try not to take risks. I wouldn't be able to live with myself if I somehow managed a breakthrough infection and put them at risk just because I wanted to go to the pool or the bar or something.
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12Goblins
Lil’ Gobbie
BBC article on natural immunity vs vaccination:
Covid: What’s the best way to top up our immunity? - BBC News
Now we have some protection, do we need to keep boosting or can nature take its course?
It talks about antibodies and memory T-cells. Surprised the BBC allowed this to be published.
Why? it's an excellent article.
Kilau
Member
D
Deleted member 1159
Unconfirmed Member
Legally? Absolutely not. Bribery is illegal. And in over a decade of working in the industry, I’ve never seen a hint of anyone trying that and had tons of training on what you can and cannot do when it comes to wining and dining physicians and other KOLs. I’m guessing that in the history of the industry there has been untoward relationships and unethical behavior, of course, but it’s definitely not the rule and financial transactions are heavily scrutinized. FDA fees are about as straightforward as you can imagine and trying to bribe someone is likely to land your ass in jail.
poppabk
Cheeks Spread for Digital Only Future
I'm not seeing anything controversial?BBC article on natural immunity vs vaccination:
Covid: What’s the best way to top up our immunity? - BBC News
Now we have some protection, do we need to keep boosting or can nature take its course?
It talks about antibodies and memory T-cells. Surprised the BBC allowed this to be published.
Impressive amount of enforcement resources.
Nobody_Important
“Aww, it’s so...average,” she said to him in a cold brick of passion
This just blows my mind. People are so stupid that they will take horse medication, but they won't go to CVS and get a vaccine.
Actual.
Fucking.
Morons.
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D
Deleted member 1159
Unconfirmed Member
Bret Weinstein sure is looking out for the public good with his bullshit
Toons
Member
That's how you know a lot of the skepticism over approval and stuff is BS.
If you were skeptical of the stuff coming from the medical field then why do you trust Joe Blow to give you horse medicine?
BadBurger
Many “Whelps”! Handle It!
Yea, basically, if one wants to learn about skepticism read Carl Sagan's collection of essays The Demon Haunted World: Science as a Candle in the Dark. He explains skepticism perfectly throughout. Zefah seemed like a cool, intelligent guy, but he wanted to squat in a position rather than merely following evidence.
BadBurger
Many “Whelps”! Handle It!
"If it doesn't fit the narrative I was fed on Facebook and YouTube, it isn't real. Excuse me while I drive out to the country to buy some horse dewormer".
Edit:
With all of the complaining about CDC and FDA data collection I felt compelled to respond, as an actual healthcare IT worker who has worked with both agencies in the past to connect them to life-saving data in my network.
I just want to remind every doubter that they have limited resources like all other government agencies that rely on actual human beings to collect, parse, and analyze data. Do you really want them wasting time on trying to figure out the exact number of vaccinated people who test positive but never feel the need to check into an overwhelmed hospital just to be sent home because 99.9x% of the time they're going to fine, rather than focusing on how well the vaccines are holding up against a variant (so this data can be shared to tailor future vaccines to fight variants)? Or how well vaccinated people respond when they develop the COVID-19 disease? Which leads to more desperately needed information in responding to future variants?
I really want to invite some of these anti-vaxxers into my daily work life of now 50+ hour weeks, take them on a tour of the massively depressing hospital floors of the overwhelmed doctors, nurses, and technicians, surrounded by the dying unvaccinated during these outbreaks - OF ALL AGES (yes, even our pediatric ICU ward is maxed). We cannot coddle your kind any longer. In the most plain English: you are being stupid and getting people killed. Please stop.
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D
Deleted member 1159
Unconfirmed Member
…wait, so do you know where I can get some?
Yep, read it as a teenager and it helped shape my worldview. Highly recommended.
Thesuffering79
Banned
Didnt need to before. Like before this was there were only a thousand cases total or something.
poppabk
Cheeks Spread for Digital Only Future
Australia almost nailed it, thanks to being an island and a very stringent lockdown. But that meant there was no imperative to get vaccinated and now the extra transmissible Delta just refuses to be contained.
Rentahamster
Rodent Whores
I just listened to some of his radio show clips, and he was using the "why should I get a vaccine against something that's 99.5% survivable" rationalization.
Outspoken conservative radio host Phil Valentine dies after battling COVID-19
Longtime conservative talk radio host Phil Valentine has died from COVID-19.www.newschannel5.com
Bad math can be deadly if applied to personal risk assessment amidst an information deficit. Very sad.
Jaysen
Banned
Havent you heard? If you’re nice to morons, they’ll stop being morons.
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Thesuffering79
Banned
Has there been a case of under 16s getting cytokine storm that was otherwise healthy?
Rentahamster
Rodent Whores
Damn, I just read an article about the plight of a guy in Texas who led anti-mask rallies who is now in the ICU with COVID19. He said he didn't want to get a COVID test lest he become part of the statistics. I can't imagine how stubborn one must have to be to think that way. The article also said he was taking Ivermectin, zinc, vitamin C, and aspirin (I assume he did that in lieu of vaccination), but obviously that didn't help either.
I hope he pulls through and tries to get people to take this more seriously.
And if society basically coerced or mandated that you go to that bar or pool that presents minimal risk to you? That's basically how folks who don't want the vaccine feel right now.
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Rentahamster
Rodent Whores
Facts don't care about their feelings. The facts are that unvaccinated people are a public health danger to both themselves and the people close to them. Public policy must acknowledge this and then balance it appropriately with other first principles like constitutional freedoms.
"Danger" - please quantify that. Because apart from those over 70 years of age, I don't feel COVID is particularly dangerous. You're out here using words like that as if it's an *actual" dangerous disease as one typically conceives of danger. Delta variant kills something like 0.015% of people under 50 who it infects. I don't conceive of that as "danger." I actually think this is one of the main differences between people who are pro-vacine mandates and those who are opposed to them: their conception of what actually constitutes danger, or acceptable risk. Other main differences include their degree of authoritarianism, valuation of independence (granted, these may actually be one category, since authoritarianism and independence can be viewed as points on a spectrum), and their proclivity for independent thought.
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FunkMiller
Banned
If people listened to Sagan and people with his view on the world more, it would be a 1000% better place. Maybe we need a Sagan thread in communities
FunkMiller
Banned
Hard lockdown prevented cases, which led to complacency. Also, country is run by a towering idiot, who genuinely thinks god directly made him prime minister.