I testified before legislative committees (state and federal) and quickly learned that everything is for show. The idea that lawmaking bodies are genuinely interested in facts or truth is utterly false. Everything is rigged by special interests long before disinterested academics appear. Plus, the lawmakers are often too ignorant to learn from what we have to say. They read little and do so solely for the purpose of finding things that support their side or undermine their opponents' position.
Thank you for your efforts to combat the inadequacies - and outright failures!- in our current system! I appreciate you and all the information you provide us.
I agree with your analysis, in this specific case and likely many others. But one point is missing from your discussion: why are other physicians not speaking out in instances where the results of a trial or trials are insufficient to support claims of efficacy and/or safety, or when unvalidated surrogate end-points are adopted? And why would reputable physicians prescribe such inadequately tested drugs for their patients.
Hi Vinay. Now you understand my frustration of speaking at FDA ad com meetings for 20 years. Members of public get 3-5 mins and most of the OPH speakers are some how affiliated to astroturf patient/disease awareness groups including the “patients” from their clinic trials. Of course, it’s only the successful ones and not those who dropped out. There is absolutely no interest in debate from a different point of view.
Today I am Consumer Rep on Psychopharmacologic Drugs Ad Com - and am often lone vote. Safety is NOT a priority and is often an afterthought or committee thinks it will get dealt with in post-market or with a REMs program.
I just presented at Wash U about the FDA ad com process and how FDA approval does not guarantee safety or efficacy using Rexulti antipsychotic for Alzheimer’s agitation. I was only NO vote and all but two public speakers supported approval despite the horrible data and double death rates. It is often Public Citizen and National Center for Health Research that offer a critical perspective.
thank you for taking time to do this even though nothing came of it, it is important that it is on the record, unless they are jiggering that too. the problem is not a scientific or medical one, but instead one of politics and greed. most if not all federal agencies are captured by those they are meant to regulate and seem shameless in their indulgence of industry, there needs to be a real shock to the system and a thorough housecleaning
You worry they are beholden to Big Pharma? The FDA and Big Pharma are a revolving door. And they wonder why no one trusts them???
Did they follow their own rules during Covid and allow Docs to repurpose drugs?? NOPE They and the AMA discredited them. There were "alternatives" and they knew that. Should have NEVER been EUA for jabs. At least some of us woke up. Sadly there are a lot that are still asleep!!
The YT link is worth watching. -very well stated counterposition. Given the imminent approval by the FDA, this will be yet another reason to distrust our supposed drug regulators. Look forward to another rise in insurance costs.
Deja Vu...All Over again.... Isn't this EXACTLY what they did with mRNA (that basically did not work). mRNA did not give you immunity (maybe your immune system was boosted for a month or so) did not stop transmission (did not stop the spread). "they" say it made any infection less intense but my understanding ( sorry I'm an economist not an MD) is there are no clinical studies supporting that assertion. So 'they' ( don' cha' love the pronouns??) approved mRNA as a VACCINE by changing the definition of vaccine to 'somethin that created an immune response' rather than something that actually gives you immunity! That's a much lower hurdle - and a much less effective one. And we were locked up waiting for that to be approved and then Joe Biden who said he would NEVER make a vaccine mandate ( And some say Trump lies?) made it mandatory- or his FDA did. - basically the same thing. Fauci endorsed this whole process even knowing he had failed to make a vaccine for HIV. He still pushed for lockdowns until there was a vaccine. Why push to lock down people until there is a vaccine if you are an expert and know vaccines are hard to develop and that developing one might not be possible? The answer is ( seems to be) because you cheat. Fauci endorsed the Big Cheat changing the definition of a vaccine then knowing the hurdle was low and for that reason the vaccine likely would not be as effective as a 'real 'old rules' vaccine. But he promoted it and also endorsed draconian rules for forcing us ALL to get vaccinated. So this is arepeat of all that absurdity.
Since they did it once, they want to do it again. Approve something that creates a physiological response even thought that response is not sufficient to be life saving. It is sufficient to be check cashing promoting...excellent.
You may also recall some Mayor out West I believe who 'learned from the pandemic' and called the killing spree in the area a 'Public Health Crisis' and tried to use the pretext of a health crisis to impose rules usually not enforceable if there is not a medical crisis. This mayor wanted to use the pretext of a killing spree as a health crisis to impound the guns of all the people in that community. Fortunately the courts struck that one down. But make no mistake about it. Covid set a variety of precedents that we may yet see people 'uniquely' enforcing.
This particular Drug gambit is, as Artee Johnson (old SNL) might say...very interesting, but stupid.
Scary to think that lowering standards is every a good thing. Also the FDA should be shut down as they are biased and do not want negative comments and all panel members should be cleared to have no financial incentive which clearly many do. Thank you Vinay for your continuing efforts.
What else is new? They are captured along with most other agencies. Who do I trust? It certainly will never be FDA. I choose to listen to people like you when it comes to health questions and advice. Why do many automatically assume that the "experts" know what they are talking about rather than questioning a procedure and/or a product's safety and efficacy? We know in the long run letting someone else do our homework results in ignorance and reprehensible bowing down to "experts" who haven't put the well being of humankind first on their list.
Keep up the exposure. You are a much better journalist than any in the MSM.
I testified before legislative committees (state and federal) and quickly learned that everything is for show. The idea that lawmaking bodies are genuinely interested in facts or truth is utterly false. Everything is rigged by special interests long before disinterested academics appear. Plus, the lawmakers are often too ignorant to learn from what we have to say. They read little and do so solely for the purpose of finding things that support their side or undermine their opponents' position.
FDA, CDC and all other government alphabet agencies have been compromised.
THANK YOU for standing up, for speaking up, and for sharing it widely, especially when official channels are so corrupted and untrustworthy.
Thank you for your efforts to combat the inadequacies - and outright failures!- in our current system! I appreciate you and all the information you provide us.
Hate to say it, but defund the FDA & CDC too.
I agree with your analysis, in this specific case and likely many others. But one point is missing from your discussion: why are other physicians not speaking out in instances where the results of a trial or trials are insufficient to support claims of efficacy and/or safety, or when unvalidated surrogate end-points are adopted? And why would reputable physicians prescribe such inadequately tested drugs for their patients.
You and all of us know that is NOT their goal.
Their goal is to ensure that they get lucrative paying jobs once they leave government with the pharmaceutical industry and they retire very rich.
Hi Vinay. Now you understand my frustration of speaking at FDA ad com meetings for 20 years. Members of public get 3-5 mins and most of the OPH speakers are some how affiliated to astroturf patient/disease awareness groups including the “patients” from their clinic trials. Of course, it’s only the successful ones and not those who dropped out. There is absolutely no interest in debate from a different point of view.
Today I am Consumer Rep on Psychopharmacologic Drugs Ad Com - and am often lone vote. Safety is NOT a priority and is often an afterthought or committee thinks it will get dealt with in post-market or with a REMs program.
I just presented at Wash U about the FDA ad com process and how FDA approval does not guarantee safety or efficacy using Rexulti antipsychotic for Alzheimer’s agitation. I was only NO vote and all but two public speakers supported approval despite the horrible data and double death rates. It is often Public Citizen and National Center for Health Research that offer a critical perspective.
Here’s my link to Rexulti FDA Ad com vote
Thank you Dr. Prasad for your integrity, and your reporting. You are an important voice on the right side of history.
thank you for taking time to do this even though nothing came of it, it is important that it is on the record, unless they are jiggering that too. the problem is not a scientific or medical one, but instead one of politics and greed. most if not all federal agencies are captured by those they are meant to regulate and seem shameless in their indulgence of industry, there needs to be a real shock to the system and a thorough housecleaning
You worry they are beholden to Big Pharma? The FDA and Big Pharma are a revolving door. And they wonder why no one trusts them???
Did they follow their own rules during Covid and allow Docs to repurpose drugs?? NOPE They and the AMA discredited them. There were "alternatives" and they knew that. Should have NEVER been EUA for jabs. At least some of us woke up. Sadly there are a lot that are still asleep!!
The YT link is worth watching. -very well stated counterposition. Given the imminent approval by the FDA, this will be yet another reason to distrust our supposed drug regulators. Look forward to another rise in insurance costs.
Deja Vu...All Over again.... Isn't this EXACTLY what they did with mRNA (that basically did not work). mRNA did not give you immunity (maybe your immune system was boosted for a month or so) did not stop transmission (did not stop the spread). "they" say it made any infection less intense but my understanding ( sorry I'm an economist not an MD) is there are no clinical studies supporting that assertion. So 'they' ( don' cha' love the pronouns??) approved mRNA as a VACCINE by changing the definition of vaccine to 'somethin that created an immune response' rather than something that actually gives you immunity! That's a much lower hurdle - and a much less effective one. And we were locked up waiting for that to be approved and then Joe Biden who said he would NEVER make a vaccine mandate ( And some say Trump lies?) made it mandatory- or his FDA did. - basically the same thing. Fauci endorsed this whole process even knowing he had failed to make a vaccine for HIV. He still pushed for lockdowns until there was a vaccine. Why push to lock down people until there is a vaccine if you are an expert and know vaccines are hard to develop and that developing one might not be possible? The answer is ( seems to be) because you cheat. Fauci endorsed the Big Cheat changing the definition of a vaccine then knowing the hurdle was low and for that reason the vaccine likely would not be as effective as a 'real 'old rules' vaccine. But he promoted it and also endorsed draconian rules for forcing us ALL to get vaccinated. So this is arepeat of all that absurdity.
Since they did it once, they want to do it again. Approve something that creates a physiological response even thought that response is not sufficient to be life saving. It is sufficient to be check cashing promoting...excellent.
You may also recall some Mayor out West I believe who 'learned from the pandemic' and called the killing spree in the area a 'Public Health Crisis' and tried to use the pretext of a health crisis to impose rules usually not enforceable if there is not a medical crisis. This mayor wanted to use the pretext of a killing spree as a health crisis to impound the guns of all the people in that community. Fortunately the courts struck that one down. But make no mistake about it. Covid set a variety of precedents that we may yet see people 'uniquely' enforcing.
This particular Drug gambit is, as Artee Johnson (old SNL) might say...very interesting, but stupid.
.
Scary to think that lowering standards is every a good thing. Also the FDA should be shut down as they are biased and do not want negative comments and all panel members should be cleared to have no financial incentive which clearly many do. Thank you Vinay for your continuing efforts.
What else is new? They are captured along with most other agencies. Who do I trust? It certainly will never be FDA. I choose to listen to people like you when it comes to health questions and advice. Why do many automatically assume that the "experts" know what they are talking about rather than questioning a procedure and/or a product's safety and efficacy? We know in the long run letting someone else do our homework results in ignorance and reprehensible bowing down to "experts" who haven't put the well being of humankind first on their list.