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TSOT122: The FDA USUALLY ignores its OWN "Four Pillars" for Drug Safety and Efficacy
Manage episode 493705793 series 2983590
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Mainly discussing topics introduced in The Lever's article "
FDA Approved — And Ineffective"
From 2013 through 2022, 73% of drugs approved by the FDA didn’t meet the agency’s four foundational standards required to show the drugs work as expected.
Fifty-five of the approved drugs met only ONE of those four standards.
39 met NONE of them.
The pillars:
- Control group: Patients taking the drug were compared to a control group that was given a placebo or a comparator drug.
- Replication: At least two “well-controlled” trials showed the drug was effective.
- Blinding: Subjects in the studies and the doctors who cared for them don’t know which patients are on the drug and which are in the control group.
- Clinical endpoint: The studies measured the drug’s effect on patients’ survival or function rather than a surrogate measure.
They're only the basis of good science from what we all learned in about tenth grade. But to the FDA and those that create drugs.. unimportant.
The cancer "treatment" sub-segment was even worse.
This isn't taking into account the likely much worse situation for the legally-protected-from-lawsuits vaccine corner of the market.
Drug companies committed to doing "confirmatory" studies AFTER market release just have not done them.
"Accelerated Pathway" as the foot in the door towards the FDA becoming a "passive observer" instead of a gatekeeper / true regulator / true guardian for consumer safety
"Surrogate outcomes" as a basis for how nearly every drug commercial proves that they in no way take the full calculus into account ("Yeah, but is it good overall?)
Placebos against another drug as something that reduces statistical significance
For those in the know, Demon Fearci at the ground floor of the root of the problem.
- Rexulti
- aducanumab
- Elmiron
- ticagrelor
- AZT
- Avastin
- Lidocaine
-Gardisil
- others
=============================================
"Surrogate outcomes" as a basis for how nearly every drug commercial proves that they in no way take the full calculus into account ("Yeah, but is it good overall?)
Placebos against another drug as something that reduces statistical significance
For those in the know, Demon Fearci at the ground floor of the root of the problem.
- Rexulti
- aducanumab
- Elmiron
- ticagrelor
- AZT
- Avastin
- Lidocaine
-Gardisil
- others
=============================================
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US HSS Office of Inspector General "Delays in Confirmatory Trials for Drug Applications Granted FDA’s Accelerated Approval Raise Concerns"
"Should regulatory authorities approve drugs based on surrogate endpoints?"
"Should regulatory authorities approve drugs based on surrogate endpoints?"
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