Results for “FDA”

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Brigham Buhler: The Peptide Safety Data Reveals 75,000+ Patients With Zero Adverse Events |TUH #182

Ultimate Human Podcast with Gary Brecka27 views
The discussion highlights a regulatory conflict where the FDA restricts peptide accessibility due to perceived safety data gaps, despite evidence of widespread safe use and low adverse event rates.summaryFDA Decision Context: The FDA banned dozens of peptides not due to proven harm, but citing a 'lack of safety data,' despite approximately 20 million people having used them without adverse events.takeawayBig Pharma Influence: The FDA's historical decisions are influenced by pharmaceutical lobbying; for example, pharma claimed the drug backlog was fixed, but data showed less than 6% of prescriptions were available for filtakeaway

The Project Veritas Whistleblower Justin Leslie l Episode 961

Tin Foil Hat With Sam Tripoli22 views
Justin Leslie, a former Pfizer formulation scientist, details his undercover investigation into the pharmaceutical industry, alleging that Pfizer and the FDA engaged in fraud by approving mRNA vaccines for children withosummaryPfizer FDA Bioequivalence Fraud: Leslie alleges that Pfizer gained FDA approval for a vaccine formulation for children (ages 5-12) by claiming bioequivalence to an adult formulation. He states that while the adult versiotakeaway“I was exposing that Pfizer approved a vaccine that they didn't do clinical trial testing on for kids from the ages of 5 to 12... they gamed the FDA essentially and Pfizer and FDA came together on a bioequivalence agreemquote

Supercharging A New FDA: Marty Makary on Science, Power & Patients

All-In Podcast39 views
FDA Commissioner Marty Makary outlines a comprehensive strategy to accelerate drug approvals, reduce costs, and rebuild public trust by dismantling bureaucratic inertia and challenging medical dogma.summaryClinical Trial Reform: The FDA is moving from a default requirement of two pivotal trials to one, potentially saving companies $100-300 million per drug and significantly shortening approval timelines. They are also adoptakeawayAnimal Testing Reduction: The FDA has eliminated the requirement for chimpanzee studies for monoclonal antibodies, citing low statistical power and misleading data. They are replacing animal models with computational modtakeaway

Dr. Marty Makary: FDA Commissioner on Vaccines, Chronic Diseases & Drug Prices | TUH #229

Ultimate Human Podcast with Gary Brecka125 views
Marty Makary, FDA Commissioner, outlines a mission to shift the US healthcare system from disease management to prevention, focusing on healthier food for children and faster delivery of cures.summaryThe FDA is actively rewriting the food pyramid and dietary guidelines in collaboration with the USDA. Key changes include ending the 'war on natural saturated fat,' emphasizing protein importance, and removing nine petrotakeawayThe FDA is piloting a new program to issue national priority review vouchers, aiming to get drug approval decisions in 4-8 weeks instead of years. This was demonstrated with a gene therapy for congenital deafness that shtakeaway

Vinay Prasad: Public Health in This Country Is So Broken

ReasonTV7 views
Vini Prasad, former FDA CBER director, argues that public health is fundamentally broken due to political capture and a lack of intellectual humility, citing Anthony Fauci’s policy errors and the suppression of scientifisummaryFDA Approval Standards: Prasad rejected Moderna’s initial mRNA flu vaccine application because it used an outdated control arm (an older flu vaccine) rather than the current standard of care (high-dose/adjuvanted vaccinetakeawaySystemic Bias in Safety Data: Observational studies cannot prove safety because they suffer from selection bias (healthier people take new drugs first). True safety requires large-scale, unbiased post-market surveillancetakeaway