I started it all by claiming on Twitter that the FDA was a rubber stamp. From boosters for 6 month old babies (no data), to postpartum depression drugs that are basically Xanax, to bad cancer drug approvals, in my mind, the FDA is failing the American people.
The FDA is deeply corrupt and criminal at this stage of the game.Lax would imply that they wanted to protect the public but were just a little too smug and complacent to dots the i's and cross the t's .In reality the FDA simply accepts bribes to look the other way when signing off on lethal toxins such as the CoVID 19 injections and declaring them safe and effective.
I appreciate you being willing to address the issue of objectivity in trials. It’s been apparent for a long time that there are no strict limits on what will be accepted as proof of safety or efficacy. Anything and everything will be overlooked in the interest of business.
And I’m tired of hearing and reading that randomized clinical trials can’t be done. Please, keep shouting about it—-Do the trials or get out of the business! 👍
As a scientist working in genomics for the past 14 years I found the olaparib study here in pancreatic cancer disgusting. I agree this is unethical to stop chemo when it was having an effect. The PFS games continue...
In my post below, I only addressed the unethical studies in which placebos were given instead of the usual standard of care to cancer patients. But I still didn't understand why the FDA would approve ineffective treatments, and I'm perhaps too naive to think that every one of them is a greedy SOB. So after a little research, I found a possible explanation which I don't recall Vinay ever mentioning. (Sorry if you did and I missed it). For years the FDA was criticized for taking too long to approve drugs and, as a result, many people died waiting for drugs to get approved. So in 1992 the FDA implemented an accelerated approval pathway that allowed investigational cancer drugs to be approved by demonstrating a beneficial effect on a surrogate measure (eg, progression-free survival) that is expected to predict a real clinical benefit (eg, overall survival). However, these drugs must undergo postapproval confirmatory studies to evaluate their actual clinical benefits. But the links below suggest that this has allowed pharma to exploit this loophole, as the studies are not always done, and when done, do not always demonstrate a real clinical benefit. So how much of the problem is from this loophole being exploited and should it be closed?
FDA: corporate tool. Another gift from Ronny Raygun. The FDA was slowing down drug approval and pharma profit projections. Reframed as "depriving people of beneficial medicines". The (neoliberal) Dems crumbled under pressure from their corporate overlords. Pretty simple case of corruption which Citizens United has put on steroids (good for your muscles!).
I agree Citizens United has been a disaster and the amount of $ Senators and Congressmen/women must raise to get elected is insane. Listening to some of them speak candidly, they despise all the fund raising they are forced to do and Representatives have to do it every other year! I don't know why they can't get together to do a bipartisan bill on campaign finance reform, other than the fact a large segment is so polarized that if the other side wants X, they will insist on Y, even if they originally wanted X, while some in the media excoriate anyone who dares to cooperate with the "enemy."
Without the FDA, Pharma will be able to sell whatever it wants, whenever it wants, however it wants. I’m sure Pharma would love it if there were no FDA.
I suspect that Big Pharma actually loves the FDA. The economic history of the US in the late 19th and early 20th centuries reveals many attempts by big business firms to cartelize their industries and thus restrict competition and raise prices. They all failed because it was impossible to maintain a cartel under free market conditions. If a small group of companies colluded to raise prices new competitors would come in and undercut them. They came to realize that cartels could only flourish under the protection of government regulation that imposed disproportionate costs on new smaller competitors or banned them outright. It started with the railroads and this provided an example that was taken up by other industries. The FDA evolved out of various divisions of the Agricultural Department and is interesting but too long to put into a brief comment. The cartelization of the medical and pharmaceutical industries was largely initiated by the Rockefellers. Those interested in more detail can find a complete discussion in "The Progressive Era" by Murray Rothbard.
I would favor a free market as we have for many goods and services. There are abundant sources of information on just about anything one can buy. I don't know how the supplement market is working. Personally. I think people are wasting their money on vitamins and supplements and don't recommend them to anyone. But I am not aware of any problems with them and, heaven forbid, I could be wrong in my low opinion of them.
Question....My understanding is that none of the C-19 vaccines had sufficient evidence to receive FDA approval prior to being pushed on Americans. Is that understanding correct? If so, it is quite amazing that even with the incredibly low standards the vaccines were distributed at scale. A second thought is that it seems like the FDA takes much longer to approve new drugs/methods than other government’s agencies, which logically would make one think it is because they are more rigorous, but that does not seem to be the case...thoughts?
No, I don't think you are correct, but you can review the evidence for yourself, as here's what they based their EUA upon (link below). Also, I'm pretty sure Vinay would have told us that the vaccines are not effective if that's what the data said, because, as you can see here, that's what he does! I have followed him since before he moved over to Substack from the VPZD podcast. While he has often complained that boosters are not needed for healthy young people, he has NEVER stated that the original 2-dose vaccines were ineffective or unnecessary.
I would add that there was no pandemic and no such thing as "Covid". I have given the reasons for that statement a few times on this website and received no counter argument. Possibly because my first recommendation is to actually read the initial study out of Wuhan where they claimed to have identified a novel corona virus. A careful reading of the methods section will show that no actual virus was isolated or cultured. Freedom of Information requests sent to practically all government health agencies around the world (including the CDC) have all replied that they have no samples of the virus. The so-called data on the subject is completely unreliable since it is based on "tests" that are not really tests such as PCR and antibody tests that are equally unreliable.
You are entitled to your opinion, but of course, without supporting data, it's meaningless. There's plenty of data to show they are effective at preventing severe disease, especially in older people and those with certain pre-existing conditions. Vinay would be shouting it to the rooftops if the data said otherwise. He's never been against vaccines of any sort, including the Covid vaccine. He's just against mandates. You can do whatever you want when it comes to vaccines, as can I, and I will always examine the data and act accordingly.
Sorry, but I will never rely on an impeached AG for my source of medical information. As for his claim about unblinding, once demonstrated to be effective, it is considered unethical to NOT allow those in the placebo group to get the vaccine, which requires unblinding, but not prior to demonstrating efficacy. (link #1). As for Paxton's claims about ARR vs RRR, that's a complicated topic requiring more space than this little box, but I agree both should be reported in medical research. But when talking about it with the public, it's important to emphasize the unusual circumstances in which the Covid vaccine was tested. The study was done in the midst of a raging pandemic, and it would have been unethical to instruct participants not to do the recommended mitigation strategies. Also, people who volunteer for such studies tend to demonstrate a healthy user bias and would be more likely to follow such mitigation strategies. The ARR is dependent on the initial absolute risk prior to vaccination. This absolute risk was most likely lower to begin with due to all the mitigation strategies, and this was confirmed in that there were fewer cases of infection in BOTH groups than predicted. Of course, Paxton is not a doctor and never mentioned any of this. But the studies were short and never even studied the endpoint of death, which is the one I care about. There's lots of data now to show the vaccine reduced the incidence of death from Covid among all ages, but especially in older ages. (link #2) So yup, I'll keep getting them and you keep getting your medical advice from an attorney politician. He can start his own Substack, Unsensible Medicine. Yikes, I'm getting snarky like Vinay! Sorry! :)
All but one of the so called vaccines were issued under the umbrella of Emergency Use Authorization. This designation renders the manufacturers immune to lawsuits for damage caused by their products. One product did receive some FDA approval but was not available in the US and only used some places overseas. Not available here because the manufacturers would be legally liable for any adverse effects. Obviously the pharmaceutical companies knew what they were doing---no one ever accused them of being stupid. Voters should be reminded of the malevolence of these companies and the politicians that greased the skids for them when they go to the polls next year.
Thank you Ernest. This is my understanding as well, which is what prompted my question. I wanted to see if I may have a misunderstanding. I have done rather extensive research on the vaccines and the related abuses perpetrated by big Pharma and their political and government operatives. It is clear that we, the American People, are being manipulated by ‘The System’. I am certainly going to use my vote for candidates that are determined to take on this corruption.
I don't work for the FDA, but I do work for another government regulatory agency. I don't feel up to the task of describing the level of dysfunction taking hold in Federal civil service, but I'll attempt to summarize one aspect of it. Things are growing progressively worse as staff loses the distinction between being a political appointee who advances the message of the current administration-any administration-and being civil service, charged with impartially executing the law. What matters now is pleasing the right people, always saying yes, and doing what you're told-even if it's wrong. I imagine that the regulations governing FDA approvals are actually fairly decent, but the idea of someone internal insisting that an agency just follow the regulations is becoming radical. The government is slipping into regulation by feelings. And it probably feels pretty good to the agency higher-ups to approve all these money making drugs and devices.
In the unethical studies in which one group received a placebo, did the study first obtain IRB approval? If so, sounds like that process also needs reform. Did the consent form disclose they might receive a placebo in place of the usual standard of care? A formal complaint should be filed against the companies who conducted the trials, and the IRBs that approved them (links below). Most research conducted in clinical trials is conducted by a team, most of whom are MD's. File complaints with the medical licensing boards about these docs. Contact lawyers who specialize in medical liability claims and encourage them to file class action lawsuits against the companies and individuals involved on behalf of the placebo patients. (Yes, those nasty lawyers are actually sometimes useful!) If you've already tried these approaches and nothing came of it, write about that. Also write your Senators and Congressperson and demand a meeting with them. The word is "activist," not "writeaboutitist." Not saying you shouldn't write, but it does not appear that writing alone will ever change a thing.
How many drugs get FDA approval and then months, or years later are removed from use? Obviously, big pharma always wants to have new and "improved" and much more expensive drugs coming on the market. This is how they make oodles of profit. Especially for virtually useless cancer drugs.
The FDA is easily bought off (money always talks to these super arrogant jerks) for the initial approval and then quietly some of these drugs are removed. There are no checks and balances within the gruesome agency we call the FDA. We do not see anyone policing of this deadly organization. Fines? Firings? Dismantlement?
Sure, the FDA does jettison the more harmful drugs at times before they can be marketed, but then go out of their way to sanction slightly less destructive products.
Why were some of these drugs ever approved in the first place? Simply because big pharma owns the FDA and demands that they are. Big pharma has no concerned about the safety and effectiveness of any drug. We have now witnessed that first hand over the last three years of mRNA injections. What further proof do you need? Another 25 million murdered?
The FDA is deeply corrupt and criminal at this stage of the game.Lax would imply that they wanted to protect the public but were just a little too smug and complacent to dots the i's and cross the t's .In reality the FDA simply accepts bribes to look the other way when signing off on lethal toxins such as the CoVID 19 injections and declaring them safe and effective.
Shut up... You had me at Hello
I appreciate you being willing to address the issue of objectivity in trials. It’s been apparent for a long time that there are no strict limits on what will be accepted as proof of safety or efficacy. Anything and everything will be overlooked in the interest of business.
And I’m tired of hearing and reading that randomized clinical trials can’t be done. Please, keep shouting about it—-Do the trials or get out of the business! 👍
As a scientist working in genomics for the past 14 years I found the olaparib study here in pancreatic cancer disgusting. I agree this is unethical to stop chemo when it was having an effect. The PFS games continue...
In my post below, I only addressed the unethical studies in which placebos were given instead of the usual standard of care to cancer patients. But I still didn't understand why the FDA would approve ineffective treatments, and I'm perhaps too naive to think that every one of them is a greedy SOB. So after a little research, I found a possible explanation which I don't recall Vinay ever mentioning. (Sorry if you did and I missed it). For years the FDA was criticized for taking too long to approve drugs and, as a result, many people died waiting for drugs to get approved. So in 1992 the FDA implemented an accelerated approval pathway that allowed investigational cancer drugs to be approved by demonstrating a beneficial effect on a surrogate measure (eg, progression-free survival) that is expected to predict a real clinical benefit (eg, overall survival). However, these drugs must undergo postapproval confirmatory studies to evaluate their actual clinical benefits. But the links below suggest that this has allowed pharma to exploit this loophole, as the studies are not always done, and when done, do not always demonstrate a real clinical benefit. So how much of the problem is from this loophole being exploited and should it be closed?
https://www.bmj.com/company/newsroom/investigation-finds-nearly-half-of-drugs-granted-fda-fast-track-approval-lack-proven-clinical-benefit/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6547118/
When Pharma is funding the FDA, how can they be trusted?
Exactly .Declaring a drug or injection unsafe would be tantamount to biting the hand that feeds them,
FDA: corporate tool. Another gift from Ronny Raygun. The FDA was slowing down drug approval and pharma profit projections. Reframed as "depriving people of beneficial medicines". The (neoliberal) Dems crumbled under pressure from their corporate overlords. Pretty simple case of corruption which Citizens United has put on steroids (good for your muscles!).
I agree Citizens United has been a disaster and the amount of $ Senators and Congressmen/women must raise to get elected is insane. Listening to some of them speak candidly, they despise all the fund raising they are forced to do and Representatives have to do it every other year! I don't know why they can't get together to do a bipartisan bill on campaign finance reform, other than the fact a large segment is so polarized that if the other side wants X, they will insist on Y, even if they originally wanted X, while some in the media excoriate anyone who dares to cooperate with the "enemy."
Without the FDA, Pharma will be able to sell whatever it wants, whenever it wants, however it wants. I’m sure Pharma would love it if there were no FDA.
I suspect that Big Pharma actually loves the FDA. The economic history of the US in the late 19th and early 20th centuries reveals many attempts by big business firms to cartelize their industries and thus restrict competition and raise prices. They all failed because it was impossible to maintain a cartel under free market conditions. If a small group of companies colluded to raise prices new competitors would come in and undercut them. They came to realize that cartels could only flourish under the protection of government regulation that imposed disproportionate costs on new smaller competitors or banned them outright. It started with the railroads and this provided an example that was taken up by other industries. The FDA evolved out of various divisions of the Agricultural Department and is interesting but too long to put into a brief comment. The cartelization of the medical and pharmaceutical industries was largely initiated by the Rockefellers. Those interested in more detail can find a complete discussion in "The Progressive Era" by Murray Rothbard.
Then what is your alternative to the FDA? People love to complain, but they don’t love to come up with solutions.
What do you think an unregulated medical device and drug market would look like? The supplement market? How well is that working?
I would favor a free market as we have for many goods and services. There are abundant sources of information on just about anything one can buy. I don't know how the supplement market is working. Personally. I think people are wasting their money on vitamins and supplements and don't recommend them to anyone. But I am not aware of any problems with them and, heaven forbid, I could be wrong in my low opinion of them.
Question....My understanding is that none of the C-19 vaccines had sufficient evidence to receive FDA approval prior to being pushed on Americans. Is that understanding correct? If so, it is quite amazing that even with the incredibly low standards the vaccines were distributed at scale. A second thought is that it seems like the FDA takes much longer to approve new drugs/methods than other government’s agencies, which logically would make one think it is because they are more rigorous, but that does not seem to be the case...thoughts?
That is correct.
No, I don't think you are correct, but you can review the evidence for yourself, as here's what they based their EUA upon (link below). Also, I'm pretty sure Vinay would have told us that the vaccines are not effective if that's what the data said, because, as you can see here, that's what he does! I have followed him since before he moved over to Substack from the VPZD podcast. While he has often complained that boosters are not needed for healthy young people, he has NEVER stated that the original 2-dose vaccines were ineffective or unnecessary.
https://www.fda.gov/media/144337/download
I’ll state it- they were ineffective and unnecessary.
I would add that there was no pandemic and no such thing as "Covid". I have given the reasons for that statement a few times on this website and received no counter argument. Possibly because my first recommendation is to actually read the initial study out of Wuhan where they claimed to have identified a novel corona virus. A careful reading of the methods section will show that no actual virus was isolated or cultured. Freedom of Information requests sent to practically all government health agencies around the world (including the CDC) have all replied that they have no samples of the virus. The so-called data on the subject is completely unreliable since it is based on "tests" that are not really tests such as PCR and antibody tests that are equally unreliable.
You are entitled to your opinion, but of course, without supporting data, it's meaningless. There's plenty of data to show they are effective at preventing severe disease, especially in older people and those with certain pre-existing conditions. Vinay would be shouting it to the rooftops if the data said otherwise. He's never been against vaccines of any sort, including the Covid vaccine. He's just against mandates. You can do whatever you want when it comes to vaccines, as can I, and I will always examine the data and act accordingly.
https://x.com/TheChiefNerd/status/1733663016481181747?s=20
Sorry, but I will never rely on an impeached AG for my source of medical information. As for his claim about unblinding, once demonstrated to be effective, it is considered unethical to NOT allow those in the placebo group to get the vaccine, which requires unblinding, but not prior to demonstrating efficacy. (link #1). As for Paxton's claims about ARR vs RRR, that's a complicated topic requiring more space than this little box, but I agree both should be reported in medical research. But when talking about it with the public, it's important to emphasize the unusual circumstances in which the Covid vaccine was tested. The study was done in the midst of a raging pandemic, and it would have been unethical to instruct participants not to do the recommended mitigation strategies. Also, people who volunteer for such studies tend to demonstrate a healthy user bias and would be more likely to follow such mitigation strategies. The ARR is dependent on the initial absolute risk prior to vaccination. This absolute risk was most likely lower to begin with due to all the mitigation strategies, and this was confirmed in that there were fewer cases of infection in BOTH groups than predicted. Of course, Paxton is not a doctor and never mentioned any of this. But the studies were short and never even studied the endpoint of death, which is the one I care about. There's lots of data now to show the vaccine reduced the incidence of death from Covid among all ages, but especially in older ages. (link #2) So yup, I'll keep getting them and you keep getting your medical advice from an attorney politician. He can start his own Substack, Unsensible Medicine. Yikes, I'm getting snarky like Vinay! Sorry! :)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8264198/#:~:text=In early 2021, both Pfizer,vaccine (13, 14).
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10247887/#:~:text=Results,for people aged 90+ years.
All but one of the so called vaccines were issued under the umbrella of Emergency Use Authorization. This designation renders the manufacturers immune to lawsuits for damage caused by their products. One product did receive some FDA approval but was not available in the US and only used some places overseas. Not available here because the manufacturers would be legally liable for any adverse effects. Obviously the pharmaceutical companies knew what they were doing---no one ever accused them of being stupid. Voters should be reminded of the malevolence of these companies and the politicians that greased the skids for them when they go to the polls next year.
Thank you Ernest. This is my understanding as well, which is what prompted my question. I wanted to see if I may have a misunderstanding. I have done rather extensive research on the vaccines and the related abuses perpetrated by big Pharma and their political and government operatives. It is clear that we, the American People, are being manipulated by ‘The System’. I am certainly going to use my vote for candidates that are determined to take on this corruption.
I don't work for the FDA, but I do work for another government regulatory agency. I don't feel up to the task of describing the level of dysfunction taking hold in Federal civil service, but I'll attempt to summarize one aspect of it. Things are growing progressively worse as staff loses the distinction between being a political appointee who advances the message of the current administration-any administration-and being civil service, charged with impartially executing the law. What matters now is pleasing the right people, always saying yes, and doing what you're told-even if it's wrong. I imagine that the regulations governing FDA approvals are actually fairly decent, but the idea of someone internal insisting that an agency just follow the regulations is becoming radical. The government is slipping into regulation by feelings. And it probably feels pretty good to the agency higher-ups to approve all these money making drugs and devices.
Toby Roger’s describes the pharma machine well: https://open.substack.com/pub/tobyrogers/p/what-we-are-up-against?r=578gw&utm_medium=ios&utm_campaign=post
In the unethical studies in which one group received a placebo, did the study first obtain IRB approval? If so, sounds like that process also needs reform. Did the consent form disclose they might receive a placebo in place of the usual standard of care? A formal complaint should be filed against the companies who conducted the trials, and the IRBs that approved them (links below). Most research conducted in clinical trials is conducted by a team, most of whom are MD's. File complaints with the medical licensing boards about these docs. Contact lawyers who specialize in medical liability claims and encourage them to file class action lawsuits against the companies and individuals involved on behalf of the placebo patients. (Yes, those nasty lawyers are actually sometimes useful!) If you've already tried these approaches and nothing came of it, write about that. Also write your Senators and Congressperson and demand a meeting with them. The word is "activist," not "writeaboutitist." Not saying you shouldn't write, but it does not appear that writing alone will ever change a thing.
https://www.hhs.gov/ohrp/compliance-and-reporting/submitting-a-complaint/index.html#:~:text=OHRP recommends that you contact,in the informed consent document.
https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/reporting-complaints-related-fda-regulated-clinical-trials
Vinay’s hyperbole keeps them on their toes
How many drugs get FDA approval and then months, or years later are removed from use? Obviously, big pharma always wants to have new and "improved" and much more expensive drugs coming on the market. This is how they make oodles of profit. Especially for virtually useless cancer drugs.
The FDA is easily bought off (money always talks to these super arrogant jerks) for the initial approval and then quietly some of these drugs are removed. There are no checks and balances within the gruesome agency we call the FDA. We do not see anyone policing of this deadly organization. Fines? Firings? Dismantlement?
Sure, the FDA does jettison the more harmful drugs at times before they can be marketed, but then go out of their way to sanction slightly less destructive products.
Why were some of these drugs ever approved in the first place? Simply because big pharma owns the FDA and demands that they are. Big pharma has no concerned about the safety and effectiveness of any drug. We have now witnessed that first hand over the last three years of mRNA injections. What further proof do you need? Another 25 million murdered?
It is time to defund the FDA, CDC, NIH and others.
Conflicts of interest have run amok.
Is the FDA too lax???? Sorry but maybe I am falling into a trap not gonna read this article if that is your question.