051 PT.1 CANCER How Big Pharma Captured the FDA.

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051 PT.1 CANCER How Big Pharma Captured the FDA.

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The Origins and Role of the FDA Established under the Pure Food and Drug Act of 1906 and expanded in 1938 following a fatal drug poisoning tragedy, the U.S. Food and Drug Administration (FDA) was created to protect public health. Its activities range from evaluating new medical therapies to conducting undercover operations via its Office of Criminal Investigations, such as exposing counterfeit chemotherapy smugglers in Puerto Rico. PDUFA and Industry Influence In 1992, in response to protests by AIDS activists over delayed approvals, Congress passed the Prescription Drug User Fee Act (PDUFA), allowing the FDA to collect fees directly from pharmaceutical companies to fund review personnel. While this reduced average drug review times from over two years to 14 months, it sparked persistent concerns regarding industry influence. Reports cite post-approval financial rewards for advisory doctor panelists, such as one cardiologist receiving over $200,000 from AstraZeneca after approving Brilinta. Furthermore, studies show that expedited cancer drugs carry higher safety label revision rates, and 56% lack evidence of overall survival benefit. The Cancer Market and Controversies The U.S. cancer treatment market generates $100 billion annually. While medical consensus holds that cancer is a complex umbrella of over 100 distinct diseases—making a single universal cure unlikely—critics argue the immense market creates financial incentives to favor chronic management. The agency also combats unproven alternatives, such as the Burzynski Clinic’s $9,000-per-month urine-derived antineoplaston therapy. Whistleblowers and Systemic Concerns Former FDA officials have voiced severe internal critiques. Ex-Commissioner Dr. Herbert Ley Jr. disclosed experiencing relentless industry pressure, while FDA scientist Dr. David Graham alleged the agency deliberately suppressed major drug safety risks like Vioxx. These institutional vulnerabilities set the foundation for examining broader theories surrounding cancer cure suppression.

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IWelcome to the HISTORY AMERICAN podcast. We explore the stories that transformed the opinions of our citizens and shaped our collective memory. Here, we don’t just narrate the past: we analyze and focus on the events that live on in the mind of America. A journey to the heart of the facts that defined us.

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