By Maryanne Demasi, PhD The US Food and Drug Administration (FDA) has a legal obligation to protect the public and ensure that the benefits of medicines outweigh the harms before being marketed to people. But the agency’s increasing reliance on pharmaceutical industry money has seen the FDA’s evidentiary standards for drug approvals significantly decline.
"the declining evidentiary standards, shortening approval times, and increasing industry involvement in FDA decision-making, has led to distrust, not only of the agency, but in the safety and effectiveness of medicines, in general."
Add to this the generic drug fiasco (e.g. Bottle of Lies, K. Eban) and I find myself in the unsavory place of having to question/doubt both the evidentiary basis AND quality control of any pharmaceutical I ingest.
Dear Ms. Demasi, I am pharmacist from Slovenia (EU member state). This is one of the best articles I have ever read. Factual, correct and simple. Such articles are the hardest to write, because you have to know your subject very well and also have time to make it work. Excelent work! Yours sincerely, Mitja Ferlež
Thank you MaryAnne for providing a succinct window of enlightenment into the declining standards (outright failure?) of the FDA to fundamentally protect the public without conflict of interest. Everyone needs to read this substack and share as widely as possible. I hope that you are able to write a book! Those of us who have seen the direct harms from products now withdrawn (but too late for those suffering or no longer with us) understand where things started to go terribly wrong. I no longer trust the development and approval of any pharmaceutical products.
You've heard the term 'closing the door after the horse left the barn'? That is where I'm at with the FDA. I would not trust a agency (FDA or CDC) that allowed money be their motivation and guide, throwing the people of the world to the wolves... Every one there who did not quit and let this garbage out of the bag is complicit. And there you are naked without a shred of INTEGRITY.
Someone please correct me if I am wrong with this. I was looking at how many drugs were on the market which is 20,000 and how many people would be needed for the clinical trial.
20k × 30k = 600,000,000!
People may argue that some trials would be smaller but there much larger trials too. The Polio vaccine trials of the 50's were massive even by todays standards. 1.8 million children with 600,000 taking the shots.
So 20 vaccines would need 5-10 million people
And there are all the clinical trials of drugs, vaccines, operations(?) And the RCT's of diets and finding out different benefits/harms of drugs and vitamins.
Just vitamin C has probably been tested on millions of people for different conditions.
I guess the whole point of my post is this - has every one on Earth been in a clinical trial at this point? It has to be in the billions of people. Which is strange as I don't know a single person who has been in one!
Imagine if these companies were just doing the trials on 30 people and just added the extra zeros when it came time to publish.
Consider opening up a paid option via substack! I'm subscribed through Paypal but it was a bitch to set up and I tried/failed a couple times before dedicating enough time to set it up. Many months elapsed between efforts. Perhaps there are others like me - FYI.
"the declining evidentiary standards, shortening approval times, and increasing industry involvement in FDA decision-making, has led to distrust, not only of the agency, but in the safety and effectiveness of medicines, in general."
Add to this the generic drug fiasco (e.g. Bottle of Lies, K. Eban) and I find myself in the unsavory place of having to question/doubt both the evidentiary basis AND quality control of any pharmaceutical I ingest.
Thanks for covering this!
Dear Ms. Demasi, I am pharmacist from Slovenia (EU member state). This is one of the best articles I have ever read. Factual, correct and simple. Such articles are the hardest to write, because you have to know your subject very well and also have time to make it work. Excelent work! Yours sincerely, Mitja Ferlež
An outstanding piece of journalism from MD and another nail in the coffin of EBM. Well done.
this is really awesome content i haven't seen anywhere else. welcome to substack.
Thank you MaryAnne for providing a succinct window of enlightenment into the declining standards (outright failure?) of the FDA to fundamentally protect the public without conflict of interest. Everyone needs to read this substack and share as widely as possible. I hope that you are able to write a book! Those of us who have seen the direct harms from products now withdrawn (but too late for those suffering or no longer with us) understand where things started to go terribly wrong. I no longer trust the development and approval of any pharmaceutical products.
You've heard the term 'closing the door after the horse left the barn'? That is where I'm at with the FDA. I would not trust a agency (FDA or CDC) that allowed money be their motivation and guide, throwing the people of the world to the wolves... Every one there who did not quit and let this garbage out of the bag is complicit. And there you are naked without a shred of INTEGRITY.
you mean UP UNTIL 1988...?
"In 1988, only 4% of new drugs introduced onto the global market were approved first by the FDA, but that rose to 66% by 1998"
you mean UP UNTIL 1988...?
״In 1988, only 4% of new drugs introduced onto the global market were approved first by the FDA, but that rose to 66% by 1998״
Someone please correct me if I am wrong with this. I was looking at how many drugs were on the market which is 20,000 and how many people would be needed for the clinical trial.
20k × 30k = 600,000,000!
People may argue that some trials would be smaller but there much larger trials too. The Polio vaccine trials of the 50's were massive even by todays standards. 1.8 million children with 600,000 taking the shots.
So 20 vaccines would need 5-10 million people
And there are all the clinical trials of drugs, vaccines, operations(?) And the RCT's of diets and finding out different benefits/harms of drugs and vitamins.
Just vitamin C has probably been tested on millions of people for different conditions.
I guess the whole point of my post is this - has every one on Earth been in a clinical trial at this point? It has to be in the billions of people. Which is strange as I don't know a single person who has been in one!
Imagine if these companies were just doing the trials on 30 people and just added the extra zeros when it came time to publish.
Consider opening up a paid option via substack! I'm subscribed through Paypal but it was a bitch to set up and I tried/failed a couple times before dedicating enough time to set it up. Many months elapsed between efforts. Perhaps there are others like me - FYI.