FDA Corruption Letter

[Drareg]

Oh wow, can you believe the FDA have corruption issues? As usual it’s at the top of the institution, big pharma executives along with ruling class are clearly dosing their own toxic products like anti-psychotics/SSRI’s etc , the corruption in western institutions is out of control and in the realm of full blown cocaine and hookers territory at this point.
Party boy bomber Obama must have misplaced the letter on the covid riddled dance floor somewhere.

Don’t worry you folks in the covidian cult you can still trust the FDA for vaccines and covid19 diligence, just believe, have faith and you will be saved.

@haidut

FDA "Corruption" Letter Authenticated: Lawyers, Start Your Engines!

Lawyers who want to sue drug companies will be drooling over the news that the FDA has "certified" a 2009 letter sent anonymously by FDA staff to President Obama describing "systemic corruption and wrongdoing that permeates all levels of FDA."

www.cbsnews.com

Lawyers who want to sue drug companies will be drooling over the news that the FDA has "certified" a 2009 letter sent anonymously by FDA staff to President Obama describing "systemic corruption and wrongdoing that permeates all levels of FDA."


The FDA's official recognition of the letter means that lawyers who want to use it to demonstrate that the FDA isn't perfect won't have to go through weeks of tedious discovery demands to find someone at the FDA who can officially say, "Yup, we sent that." That's going to be a headache for drug companies who often defend their drugs in court by saying, "Hey, the FDA said this product was fine and we did everything they asked -- so it's not fair to hold us responsible."

Plaintiffs' lawyers can now hold up the letter in court and argue that drug companies have been on notice that the FDA is riddled with politics, conflicts of interest and outright corruption, and is, as the letter says, "fundamentally broken."

 

[Lollipop2]

This is great news. I do hope like you say it gets used in court cases...

 

[yerrag]

Nice. I hope it can be used well and to the extent the big pharma companies are fined and their top executives face the firing squad.

Haha, we wish, don't we? Not as long as there is a presidential pardon. Z crooks get away because their rabbi will always vouch for their "good" character.

Tweedle dee tweedle dum. Just like Sisyphus.

 

[tankasnowgod]

This is great news. I do hope like you say it gets used in court cases...

Well, I'm sure it has been, seeing as the story is from 2010.

Of course, it can't be used against any of the EUA drugs, seeing as drug companies have immunity with that designation. But, maybe, if one of these drugs gets "full approval," that could change. I can see some lawyer arguing that "systemic corruption" at the FDA led to a new class of drugs with a hugely problematic research and trial history being classified as one of the oldest (brand new 'mRNA drugs" being classified as over 2 centuries old "vaccines"), and as such, should have no immunity from the 1986 National Childhood Vaccine Injury Act. Since mRNA tech didn't even exist in 1986, how could Congress have granted drug manufactures full immunity for those drugs?

 

[Seven]

In a recent interview with Fox's Bartiromo, Trump insinuated that at least one pharmaceutical company "owned" the FDA. He wouldn't say it directly and ruled out JNJ but then started maligning the head of Pfizer. Some other information I read indicates that Pfizer is quite the bully and dictates conditions to other countries to fully relieve itself of any liability.

You can suffer through the interview clip here:

Trump rips Pfizer, accuses CEO of profiteering with vaccine boosters

"That sounds to me like a money-making operation for Pfizer"

www.salon.com

 

[yerrag]

In a recent interview with Fox's Bartiromo, Trump insinuated that at least one pharmaceutical company "owned" the FDA. He wouldn't say it directly and ruled out JNJ but then started maligning the head of Pfizer. Some other information I read indicates that Pfizer is quite the bully and dictates conditions to other countries to fully relieve itself of any liability.

True.

There was a delay in getting Pfizer to the Philippines, and it's because Pfizer wanted to ensure total immunity. A few years ago, Sanofi introduced an mRNA dengue vaccine that resulted in deaths of many children, and Sanofi was sued, or is still being sued. Pfizer had to make its vaccines got here with immunity protection. Our president Duterteis fully behind our health secretary Duque in following the WHO and it's Zionist masters. A true colony of USZ, Duterte surely saw the writing on the wall and he prefers to leave office alive than be a dead hero.

 

[Funnywhensunny]

Oh wow, can you believe the FDA have corruption issues? As usual it’s at the top of the institution, big pharma executives along with ruling class are clearly dosing their own toxic products like anti-psychotics/SSRI’s etc , the corruption in western institutions is out of control and in the realm of full blown cocaine and hookers territory at this point.
Party boy bomber Obama must have misplaced the letter on the covid riddled dance floor somewhere.

Don’t worry you folks in the covidian cult you can still trust the FDA for vaccines and covid19 diligence, just believe, have faith and you will be saved.

@haidut

FDA "Corruption" Letter Authenticated: Lawyers, Start Your Engines!

Lawyers who want to sue drug companies will be drooling over the news that the FDA has "certified" a 2009 letter sent anonymously by FDA staff to President Obama describing "systemic corruption and wrongdoing that permeates all levels of FDA."

www.cbsnews.com

Lawyers who want to sue drug companies will be drooling over the news that the FDA has "certified" a 2009 letter sent anonymously by FDA staff to President Obama describing "systemic corruption and wrongdoing that permeates all levels of FDA."


The FDA's official recognition of the letter means that lawyers who want to use it to demonstrate that the FDA isn't perfect won't have to go through weeks of tedious discovery demands to find someone at the FDA who can officially say, "Yup, we sent that." That's going to be a headache for drug companies who often defend their drugs in court by saying, "Hey, the FDA said this product was fine and we did everything they asked -- so it's not fair to hold us responsible."

Plaintiffs' lawyers can now hold up the letter in court and argue that drug companies have been on notice that the FDA is riddled with politics, conflicts of interest and outright corruption, and is, as the letter says, "fundamentally broken."

But will the corrupt judges ever hear these cases? I have yet to hear...

 

[Lollipop2]

Since mRNA tech didn't even exist in 1986, how could Congress have granted drug manufactures full immunity for those drugs?

Good point. At some point endless immunity from consequences must end - can not be perpetual.

 

[Drareg]

But will the corrupt judges ever hear these cases? I have yet to hear...

Right, what good is legislation when it isn’t enforced, see Wall Street as an example.

 

[haidut]

Oh wow, can you believe the FDA have corruption issues? As usual it’s at the top of the institution, big pharma executives along with ruling class are clearly dosing their own toxic products like anti-psychotics/SSRI’s etc , the corruption in western institutions is out of control and in the realm of full blown cocaine and hookers territory at this point.
Party boy bomber Obama must have misplaced the letter on the covid riddled dance floor somewhere.

Don’t worry you folks in the covidian cult you can still trust the FDA for vaccines and covid19 diligence, just believe, have faith and you will be saved.

@haidut

FDA "Corruption" Letter Authenticated: Lawyers, Start Your Engines!

Lawyers who want to sue drug companies will be drooling over the news that the FDA has "certified" a 2009 letter sent anonymously by FDA staff to President Obama describing "systemic corruption and wrongdoing that permeates all levels of FDA."

www.cbsnews.com

Lawyers who want to sue drug companies will be drooling over the news that the FDA has "certified" a 2009 letter sent anonymously by FDA staff to President Obama describing "systemic corruption and wrongdoing that permeates all levels of FDA."


The FDA's official recognition of the letter means that lawyers who want to use it to demonstrate that the FDA isn't perfect won't have to go through weeks of tedious discovery demands to find someone at the FDA who can officially say, "Yup, we sent that." That's going to be a headache for drug companies who often defend their drugs in court by saying, "Hey, the FDA said this product was fine and we did everything they asked -- so it's not fair to hold us responsible."

Plaintiffs' lawyers can now hold up the letter in court and argue that drug companies have been on notice that the FDA is riddled with politics, conflicts of interest and outright corruption, and is, as the letter says, "fundamentally broken."

Good to see FDA acknowledge its own culpability. There have been a few blatant examples of its corruption, but so far everything had been in the realm of "a few bad apples" stories about a specific drug or specific pharma company acting bad. This letter finally says what we all know - the entire FDA is corrupt from the ground up, and in all likelihood cannot be reformed.

Flagship Blood Thinner Worse Than Aspirin For Preventing Strokes, Trial Halted

Many of you may have seen the ads on TV for the blood thinner Xarelto. Sadly, those ads have lately started to show increasingly younger people with apparent blood clotting issues, some of them clearly in their 20s. Xarelto is the latest attempt of the pharma industry to replace the old and...

raypeatforum.com

And a more recent case is the resignation of the top advisory board members over FDA going against their advice and approving an Alzheimer's drug that was proven to be no better than placebo, while still having bad side effects.

3 Experts Have Resigned From An FDA Committee Over Alzheimer's Drug Approval

In his resignation letter, Dr. Aaron Kesselheim calls it "probably the worst drug approval decision in recent U.S. history." An FDA official says the agency found the benefits outweighed the risks.

www.npr.org

The very purpose of this advisory board is to basically look at the data and decide if a drug is worth approving. They are the "experts", which the FDA hired for this very reason. Yet, when it suited the pharma company the FDA political leaders showed they are free to ignore any science or analysis they don't like. That board itself has been suspected of being bought/corrupt, and the fact that people are resigning from it in defiance of FDA leadership shows that the situation in the agency is much much worse compared to the board.

 

[Kram]

Another good article on corruption issues.

Serious Risks And Few New Benefits From FDA-Approved Drugs | Health Affairs Blog

Let's look at the Food and Drug Administration’s failure to protect the 170 million Americans who take prescription drugs from adverse reactions that are killing more than 2,400 people every week. Annually, prescription drugs cause over 81 million adverse reactions and result in 2.7 million...

www.healthaffairs.org

Specifically:

Institutional Corruption​

These startling results reflect studies from the Edmond J. Safra Center for Ethics at Harvard University, where research fellows have investigated “institutional corruption” in the pharmaceutical industry. “Institutional corruption” refers to systemic, legal ways that social institutions such as medical science, the medical profession, and the FDA become compromised by corporate and special-interest funding and influence.

Peer-reviewed studies already demonstrate how pharmaceutical companies manipulate FDA rules to generate evidence that their new drugs are more effective and less harmful than unbiased studies would show. The industry then recruits teams of medical writers, editors, and statisticians to select and repackage trial results into peer-reviewed articles that become accepted as reliable medical knowledge.

Based on his investigations, Marc Rodwin concludes, “Scholarly studies have revealed that drug firms design trials that skew the results and that they distort the evidence by selective reporting or biased interpretation.” This distorted evidence goes into clinical guidelines that become, Lisa Cosgrove and Emily Wheeler note, “essentially marketing tools for drug companies.”

Often Neither Safe Nor Effective​

The Center for Drug Evaluation and Research (CDER – pronounced “C-DER”) is the FDA division responsible for determining whether new drugs should be approved. Its funding, however, now largely comes not from taxpayers but from the companies submitting their drugs to CDER for review.

This clear conflict of interest and approving so many new drugs with few clinical benefits serve corporate interests more than public interests, especially given the large risks of serious harm. Direct and indirect costs to society far exceed the cost of funding the FDA as a public, independent review body.

New FDA policies to get more drugs reviewed faster so that they can reach patients sooner result ironically in even more drugs being approved with less evidence that they are either safer or more effective. Faster reviews mean the chance that a drug will generate an FDA warning of serious harm jumps from one in five to one in three.

A systematic study of shortened reviews found that each 10-month reduction in review time produced an 18 percent increase of serious adverse reactions, an 11 percent increase of drug-related hospitalizations, and a 7.2 percent increase of drug-related deaths. Only 72 out of 1,300 CDER staff are charged with investigating drug safety, hard evidence that drug safety is a low priority at the FDA.

A recent review of FDA policies in Health Affairs describes how the FDA creates initiatives that ostensibly demonstrate its concern for safety from faster approvals. But the authors then describe how these initiatives frequently fail or backfire. They report no evidence of reduced harm or improved benefit to patients receiving these expedited drugs.

People imagine the FDA has stringent standards that take months or sometimes years for companies to meet. To a degree, that’s true. But the external independent evidence cited here of few new benefits and substantial risks of harm, calls into question what all this costly, lengthy review process is about.

An anthropologist might conclude it’s an elaborate ritual to make the FDA look like a tough watchdog against unsafe and ineffective drugs while it’s an industry-funded lapdog. Consider the easy ride that the FDA gives cancer drugs, requiring little evidence of improved patient outcomes.

For example, approving that new drugs are better than placebo is a low standard when other effective drugs already exist. Placebo trials are also unethical in these situations because they deny subjects in the control arm the use of an effective drug.

Another FDA standard, to prove that approved drugs are “non-inferior,” or not too much worse than an existing drug, does not allow patients to know if the new drug is better than the one they are taking. Using substitute measures for real benefits to patients makes approved drugs look more effective than they are. Allowing randomized trials to be drawn from biased populations that exclude many people who are likely to take the drug and experience an adverse reaction makes new drugs appear safer than they are.

Why does the FDA allow paymasters to design such trials?

 

[Drareg]

Another good article on corruption issues.

Serious Risks And Few New Benefits From FDA-Approved Drugs | Health Affairs Blog

Let's look at the Food and Drug Administration’s failure to protect the 170 million Americans who take prescription drugs from adverse reactions that are killing more than 2,400 people every week. Annually, prescription drugs cause over 81 million adverse reactions and result in 2.7 million...

www.healthaffairs.org

Specifically:

Institutional Corruption​

These startling results reflect studies from the Edmond J. Safra Center for Ethics at Harvard University, where research fellows have investigated “institutional corruption” in the pharmaceutical industry. “Institutional corruption” refers to systemic, legal ways that social institutions such as medical science, the medical profession, and the FDA become compromised by corporate and special-interest funding and influence.

Peer-reviewed studies already demonstrate how pharmaceutical companies manipulate FDA rules to generate evidence that their new drugs are more effective and less harmful than unbiased studies would show. The industry then recruits teams of medical writers, editors, and statisticians to select and repackage trial results into peer-reviewed articles that become accepted as reliable medical knowledge.

Based on his investigations, Marc Rodwin concludes, “Scholarly studies have revealed that drug firms design trials that skew the results and that they distort the evidence by selective reporting or biased interpretation.” This distorted evidence goes into clinical guidelines that become, Lisa Cosgrove and Emily Wheeler note, “essentially marketing tools for drug companies.”

Often Neither Safe Nor Effective​

The Center for Drug Evaluation and Research (CDER – pronounced “C-DER”) is the FDA division responsible for determining whether new drugs should be approved. Its funding, however, now largely comes not from taxpayers but from the companies submitting their drugs to CDER for review.

This clear conflict of interest and approving so many new drugs with few clinical benefits serve corporate interests more than public interests, especially given the large risks of serious harm. Direct and indirect costs to society far exceed the cost of funding the FDA as a public, independent review body.

New FDA policies to get more drugs reviewed faster so that they can reach patients sooner result ironically in even more drugs being approved with less evidence that they are either safer or more effective. Faster reviews mean the chance that a drug will generate an FDA warning of serious harm jumps from one in five to one in three.

A systematic study of shortened reviews found that each 10-month reduction in review time produced an 18 percent increase of serious adverse reactions, an 11 percent increase of drug-related hospitalizations, and a 7.2 percent increase of drug-related deaths. Only 72 out of 1,300 CDER staff are charged with investigating drug safety, hard evidence that drug safety is a low priority at the FDA.

A recent review of FDA policies in Health Affairs describes how the FDA creates initiatives that ostensibly demonstrate its concern for safety from faster approvals. But the authors then describe how these initiatives frequently fail or backfire. They report no evidence of reduced harm or improved benefit to patients receiving these expedited drugs.

People imagine the FDA has stringent standards that take months or sometimes years for companies to meet. To a degree, that’s true. But the external independent evidence cited here of few new benefits and substantial risks of harm, calls into question what all this costly, lengthy review process is about.

An anthropologist might conclude it’s an elaborate ritual to make the FDA look like a tough watchdog against unsafe and ineffective drugs while it’s an industry-funded lapdog. Consider the easy ride that the FDA gives cancer drugs, requiring little evidence of improved patient outcomes.

For example, approving that new drugs are better than placebo is a low standard when other effective drugs already exist. Placebo trials are also unethical in these situations because they deny subjects in the control arm the use of an effective drug.

Another FDA standard, to prove that approved drugs are “non-inferior,” or not too much worse than an existing drug, does not allow patients to know if the new drug is better than the one they are taking. Using substitute measures for real benefits to patients makes approved drugs look more effective than they are. Allowing randomized trials to be drawn from biased populations that exclude many people who are likely to take the drug and experience an adverse reaction makes new drugs appear safer than they are.

Why does the FDA allow paymasters to design such trials?

Thanks, this is interesting.
The only thing for me is Edmund J. Safra was involved with questionable banking practices and possibly Iran/contra, any ethics center set up in his name is questionable particularly when it’s Harvard based.

I feel like the ruling class are looking to bring down old institutions in particular those linked to nation states, they are corrupt for sure but my suspicion is they will replace them with a corporate styled medical establishment, it’s seems this medical tyranny is an integral part of their great reset, the new medical system will be celebrated as a humanitarian inclusive utopia of sorts, we know it’s eugenics via genome editing, nano medical devices etc

 

[Peatness]

View: https://twitter.com/AlpacaAurelius/status/1432485809836511238

 

[Drareg]

View: https://twitter.com/AlpacaAurelius/status/1432485809836511238

This is what the ruling class want, they want us to turn to the big corporate world for saving, fascism, it’s big corporate that corrupted our institutions.

 

[Peatness]

This is what the ruling class want, they want us to turn to the big corporate world for saving, fascism, it’s big corporate that corrupted our institutions.

I didn’t read this as implying that we should turn to the big corporate world

 

[Drareg]

I didn’t read this as implying that we should turn to the big corporate world

It’s the problem, solution, reaction effect working on the general populace, this poster seems to be inclined this way by the continual propaganda, he may not be either but his post reflects a broader learned helplessness creeping into general discourse within the working classes, what can we do they are asking, we should be doing and that’s the realization we need.
The general rhetoric being pumped for years is government are corrupt, bad and incompetent, big tech can solve all the issues is implied, think bitcoin etc, this allows for a big tech solution like the fourth industrial revolution, a faux mediation will take -lace between government alluding to supervising big tech but allowing them greater flexibility to solve societies problems, the NGO’s will also front this in the name of protecting the small guy, it’s a front for fascism, it will sound good and necessary, fascists always use the desires of the masses during the times it arises, it uses the language of the day to imply a great utopia will arrive.

 

[Peatness]

It’s the problem, solution, reaction effect working on the general populace, this poster seems to be inclined this way by the continual propaganda, he may not be either but his post reflects a broader learned helplessness creeping into general discourse within the working classes, what can we do they are asking, we should be doing and that’s the realization we need.
The general rhetoric being pumped for years is government are corrupt, bad and incompetent, big tech can solve all the issues is implied, think bitcoin etc, this allows for a big tech solution like the fourth industrial revolution, a faux mediation will take -lace between government alluding to supervising big tech but allowing them greater flexibility to solve societies problems, the NGO’s will also front this in the name of protecting the small guy, it’s a front for fascism, it will sound good and necessary, fascists always use the desires of the masses during the times it arises, it uses the language of the day to imply a great utopia will arrive.

I agree with you on NGO’s.

I still fail to see how we can jump from calling out institutional corruption to endorsing big corporation. Perhaps people reading that post are asking themselves what can we do rather than looking to a saviour.

 

[Drareg]

I agree with you on NGO’s.

I still fail to see how we can jump from calling out institutional corruption to endorsing big corporation. Perhaps people reading that post are asking themselves what can we do rather than looking to a saviour.

I hope so, I’m not trying to implicate the person writing it as spreading disinformation in any way, Im just conscious of these narratives arising when big tech are waiting in the wings with their solutions.

 

[Lollipop2]

View: https://twitter.com/AlpacaAurelius/status/1432485809836511238

This is an example of the grand awakening. People are slowly waking up to the truth. This gives me hope. The more of these kind of posts. Eventually awakened people will demand a different system. This has been what I have been saying over the last year and a half.

 

[Drareg]

Two senior FDA leaders are stepping down because of booster vaccines, when you consider how delusional the FDA this booster must be poison.

In a major blow to vaccine efforts, senior FDA leaders stepping down

Two of the FDA's most senior vaccine leaders are exiting from their positions, raising fresh questions about the Biden administration and the way that it's sidelined the FDA. Marion Gruber, director of the FDA's Office of Vaccines Research & Review and 32-year veteran of the agency, will leave...

endpts.com

Two of the FDA’s most senior vaccine leaders are exiting from their positions, raising fresh questions about the Biden administration and the way that it’s sidelined the FDA.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and 32-year veteran of the agency, will leave at the end of October, and OVRR deputy director Phil Krause, who’s been at FDA for more than a decade, will leave in November. The news, first reported by BioCentury, is a massive blow to confidence in the agency’s ability to regulate vaccines.

The bombshell announcement comes at a particularly crucial moment, as boosters and children’s shots are being weighed by the regulator. The departures also come as the administration has recently jumped ahead of the FDA’s reviews of booster shots, announcing that they might be available by the week of Sept. 20.