Description

Howie and Harlan discuss Dr. Vinay Prasad's departure from the FDA after a backlash against his decisions on Sarepta's Duchenne muscular dystrophy gene therapy. Also examined: AI in clinical settings, changes in NIH grantmaking, and the 60th anniversary of Medicare and Medicaid.

Links:

Sarepta and the FDA

"STAT breaks down the confusing, heartbreaking Sarepta saga"

"Sarepta Therapeutics' Duchenne therapy faces 'arduous' path back to market, senior FDA official says"

"For many Duchenne families, halt to gene therapy is heartbreak upon heartbreak"

"FDA launches probe into new Elevidys death as Sarepta, Roche stress gene therapy not at fault"

"FDA Recommends Removal of Voluntary Hold for Elevidys for Ambulatory Patients"

"FDA takes U-turn on Sarepta's Elevidys, backing Duchenne gene therapy again in ambulatory patients"

"Controversial FDA official Dr. Vinay Prasad departs agency"

"Top F.D.A. Vaccine Official Resigns, Citing Kennedy's 'Misinformation and Lies'"

"Vinay Prasad Is a Bernie Sanders Acolyte in MAHA Drag"

"Timeline: The Rise and Fall of Vioxx"

"What have we learnt from Vioxx?"

THC in pizza dough

"C.D.C. Ties 85 Cases of THC-Related Symptoms to Wisconsin Restaurant"

"Tetrahydrocannabinol Intoxication from Food at a Restaurant — Wisconsin, October 2024"

NIH funding

"NIH is shrinking the number of research projects it funds due to a new Trump policy"

NIH: Supporting Fairness and Originality in NIH Research Applications

"Fearful of AI-generated grant proposals, NIH limits scientists to six applications per year"

"Trump budget draft proposes NIH consolidation and 40% spending cut"

Raw milk

"Outbreak of Salmonella Typhimurium Infections Linked to Commercially Distributed Raw Milk — California and Four Other States, September 2023–March 2024"

"The Dangers of Raw Milk: Unpasteurized Milk Can Pose a Serious Health Risk"

AI in healthcare update

"Ambience Healthcare Announces $243 Million Series C to Scale its AI Platform for Health Systems"

"As ambient scribes face off, Doximity lures doctors with a free option"

Aidoc: "AI Empowering Radiologists"

"Clinical Implementation of a Combined Artificial Intelligence and Natural Language Processing Quality Assurance Program for Pulmonary Nodule Detection in the Emergency Department Setting"

"Large Language Models as an Inexpensive and Effective Extra Set of Eyes in Radiology Reporting"

"Current Trends in Remote and Flexible Work Options in Radiology and Perception of Impact on Radiologist Well-being"

Medicare and Medicaid 60th anniversary

CMS' program history

"Medicare and Medicaid turn 60 – and face historic cuts decades in the making"

UnitedHealth and Medicare Advantage

"UnitedHealth says 2025 earnings will be worse than expected as high medical costs dog insurers"

"UnitedHealthcare to exit certain Medicare Advantage markets as costs balloon, impacting 600K enrollees"

"Novo Nordisk slides further on US competition, new CEO concerns"

"Dems Must Really Fix Medicaid, Not Just Undo Trump's Damage to It"

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