Perhaps a more basic question is why a free, adult, American Citizen needs the approval of a Government agency to take any treatment to treat a potentially lethal disease.
The FDA is a bureaucratic mess. While health related organizations may need to allow for some inefficiency, they do very few drug approvals yearly.
The right to try law in Trump 1.0 helped, but the bureaucratic risk avoidance for the people employed there still holds it back.
Which matters more, the reputational risk to an FDA employee or the risk to life of those in need of treatment?
So often the FDA seems either over or under protective of the public based on personal self interest ... either personal risk avoidance, brown nosing their administration, or showing a company preference to oil the revolving door to high paid industry jobs.
I don't pretend know how to fix this, but the recent new crew of leaders seem to see the problem and may have some impact on fixing the broken bureaucracy.
Sadly though, the US FDA and US CDC still command authority in other countries where their word is taken as gospel by those unaware of their deep corruption.
You should care a little. If the FDA and CDC are captured, as they were, and the rest of the world mirrors their madness then the USA administration will say they are following the WHO guidelines in a circular chain of reasoning. If other countries were more independent and had their own researchers and their results were DIFFERENT and the WHO was not just a rubber stamp of captured public health departments then the false consensus on how to mismanage health could not form nearly as easily, if at all.
I'm not interested in our government trying to control the world. Let everyone make their own decisions. Frankly many of the decisions made on pharmaceuticals and food additives outside the US seem right to me.
More debate, not less, is where I think we should go. Let us evaluate even some of the most widely held beliefs to see if they still hold. Debate should be encouraged not discouraged. The era of institutional control by narrative should be ended.
All of that is a separate and more broad topic than fixing the FDA in and for the USA. If other countries just accept the FDAs opinion without their own evaluation, then isn't it also true that they are using the FDAs services without supporting the FDAs cost?
That's a pretty extreme position, and to the extent others benefit from what the US does for US interests is certainly fine, except when it becomes userous. Like what has evolved over time in trade and defense of the western world.
Well to the extent it helps (and not hurts), great. Each to their own so to say.
I have no say in what some place like the UK, France, or Germany thinks or does, nor do I want one.
To the extent the US may have led others wrong, I apologize, but there is some responsibility for accepting whatever world view a given populace has.
Obviously the truth changes in the US in seemingly large shifts. I'd suggest that things really haven't changed much except in degree. Don't see the results of one election here as permanent, or even lasting ...
The US is naturally somewhat chaotic... as, I think, is intended.
I could agree with question #2 only if (1) all of the liability protection / immunity laws protecting pharma were repealed; (2) the Constitution explicitly forbade government mandates of any medical device/intervention, proven or experimental; (3) federal law explicitly forbade private companies from requiring medical interventions as a condition of employment; and (4) declarations of govt emergencies at every level of governance are made illegal
Adults (of sound mind) should be allowed to collect/extract/buy/take any chemical/treatment they like for treating their OWN medical condition.
Habit forming (morphine), easily toxic (insulin) and socially harmful (doi: 10.31887/DCNS.2003.5.2/rcasagrandetango) chemicals should be restricted in sale and but still available to consenting adults by prescription through an independent duly (credibly) licensed (obviously educated) healthcare practitioner who has the patients interest at heart.
Further there should be almost no restriction on chemicals that a consenting adult formulates or extracts for their OWN USE, it is no one else's business what I do in my house or herb garden. This means ethanol, CBD, psilocybin, mescalin that you make for your OWN USE should be totally acceptable (for other reasons relating to my soul I would not take mind altering substances on my own but will support the right for other and for myself to do so if desired).
When children or those with limited capacity to foresee outcomes, are concerned there should be consultation with the parent and duly (credibly) licensed healthcare practitioner/s who have the patients interest at heart.
Requiring licensing and manufacturing quality standards for drugs should be limited to what is SOLD and PRESCRIBED BY NON-INDEPENDENT practitioners. This is a valuable function that the FDA or similar body could and should perform. Such licensed therapeutics would then be covered by insurance policies backed by the government who licensed them and the hospital/practice that employs the doctor.
Those who use unlicensed or unqualified remedies MUST CARRY the full insurance cover for all the patients that they so treat.
This is a double edge sword. As a result of the EUA, the covid shots were not sufficiently tested and were rushed to market resulting in many people suffering from adverse effects. Safety should be number 1 before efficacy, because if it's not safe, efficacy doesn't matter. I do believe that experimental treatments should be available to anyone who wants it, if it's a life or death situation.
Perhaps a more basic question is why a free, adult, American Citizen needs the approval of a Government agency to take any treatment to treat a potentially lethal disease.
Good point.
The FDA is a bureaucratic mess. While health related organizations may need to allow for some inefficiency, they do very few drug approvals yearly.
The right to try law in Trump 1.0 helped, but the bureaucratic risk avoidance for the people employed there still holds it back.
Which matters more, the reputational risk to an FDA employee or the risk to life of those in need of treatment?
So often the FDA seems either over or under protective of the public based on personal self interest ... either personal risk avoidance, brown nosing their administration, or showing a company preference to oil the revolving door to high paid industry jobs.
I don't pretend know how to fix this, but the recent new crew of leaders seem to see the problem and may have some impact on fixing the broken bureaucracy.
Good luck to them...
Sadly though, the US FDA and US CDC still command authority in other countries where their word is taken as gospel by those unaware of their deep corruption.
Not sure I care...
@Edward GRAY
You should care a little. If the FDA and CDC are captured, as they were, and the rest of the world mirrors their madness then the USA administration will say they are following the WHO guidelines in a circular chain of reasoning. If other countries were more independent and had their own researchers and their results were DIFFERENT and the WHO was not just a rubber stamp of captured public health departments then the false consensus on how to mismanage health could not form nearly as easily, if at all.
Also @MSB
I'm not interested in our government trying to control the world. Let everyone make their own decisions. Frankly many of the decisions made on pharmaceuticals and food additives outside the US seem right to me.
More debate, not less, is where I think we should go. Let us evaluate even some of the most widely held beliefs to see if they still hold. Debate should be encouraged not discouraged. The era of institutional control by narrative should be ended.
All of that is a separate and more broad topic than fixing the FDA in and for the USA. If other countries just accept the FDAs opinion without their own evaluation, then isn't it also true that they are using the FDAs services without supporting the FDAs cost?
That's a pretty extreme position, and to the extent others benefit from what the US does for US interests is certainly fine, except when it becomes userous. Like what has evolved over time in trade and defense of the western world.
You don't need to care. I was actually responding to this because I thought other people who are also not US-based might resonate with that statement.
Well to the extent it helps (and not hurts), great. Each to their own so to say.
I have no say in what some place like the UK, France, or Germany thinks or does, nor do I want one.
To the extent the US may have led others wrong, I apologize, but there is some responsibility for accepting whatever world view a given populace has.
Obviously the truth changes in the US in seemingly large shifts. I'd suggest that things really haven't changed much except in degree. Don't see the results of one election here as permanent, or even lasting ...
The US is naturally somewhat chaotic... as, I think, is intended.
I could agree with question #2 only if (1) all of the liability protection / immunity laws protecting pharma were repealed; (2) the Constitution explicitly forbade government mandates of any medical device/intervention, proven or experimental; (3) federal law explicitly forbade private companies from requiring medical interventions as a condition of employment; and (4) declarations of govt emergencies at every level of governance are made illegal
Adults (of sound mind) should be allowed to collect/extract/buy/take any chemical/treatment they like for treating their OWN medical condition.
Habit forming (morphine), easily toxic (insulin) and socially harmful (doi: 10.31887/DCNS.2003.5.2/rcasagrandetango) chemicals should be restricted in sale and but still available to consenting adults by prescription through an independent duly (credibly) licensed (obviously educated) healthcare practitioner who has the patients interest at heart.
Further there should be almost no restriction on chemicals that a consenting adult formulates or extracts for their OWN USE, it is no one else's business what I do in my house or herb garden. This means ethanol, CBD, psilocybin, mescalin that you make for your OWN USE should be totally acceptable (for other reasons relating to my soul I would not take mind altering substances on my own but will support the right for other and for myself to do so if desired).
When children or those with limited capacity to foresee outcomes, are concerned there should be consultation with the parent and duly (credibly) licensed healthcare practitioner/s who have the patients interest at heart.
Requiring licensing and manufacturing quality standards for drugs should be limited to what is SOLD and PRESCRIBED BY NON-INDEPENDENT practitioners. This is a valuable function that the FDA or similar body could and should perform. Such licensed therapeutics would then be covered by insurance policies backed by the government who licensed them and the hospital/practice that employs the doctor.
Those who use unlicensed or unqualified remedies MUST CARRY the full insurance cover for all the patients that they so treat.
"Let food be thy medicine and medicine be thy food" Hippocrates.
Why FDA does allow toxins in our food" It seems to be FTA - Food with Toxins Administration/
Right on!!!!!
This is a double edge sword. As a result of the EUA, the covid shots were not sufficiently tested and were rushed to market resulting in many people suffering from adverse effects. Safety should be number 1 before efficacy, because if it's not safe, efficacy doesn't matter. I do believe that experimental treatments should be available to anyone who wants it, if it's a life or death situation.
Pam Bondi: Google "Polygraph test of Ella Gareeva"