Unbiased Analysis of Today's Healthcare Issues
That is the title of a paper I published today in Journal of Market Access & Health Policy with co-authors by Karim EI-Kersh, Nadine Zawadzki, Catelyn Coyle, Shurui Zhang, Dhruv Dalal, Anna Watzker, and Dominik Lautsch. The abstract is below: Pulmonary arterial hypertension (PAH) and cancer share high mortality and complex prognoses. Due to PAH’s…
Regulation and Theory of the Adjacent Possible. Alex Taborrok on Trump pharmaceutical plan. Double negotiation? IRA + MFN. Mass General Brigham will provide AI pre-visits. Are ‘mobile crisis’ teams in crisis?
FDA’s January 2026 draft guidance on Bayesian methodology in drug and biologics trials signals a clear willingness to see Bayesian methods used for regulatory decisionmaking around clinical trials. The guidance lays out how sponsors (i.e., pharmaceutical manufacturers) should pre-specify priors, success criteria, and simulations so that Bayesian designs remain interpretable, control error rates when needed,…
Let’s say that there is a very severe disease—let’s call it horriblitis—with significant impacts on patient morbidity and mortality. The only available treatment for horriblitis is drug called BlackPill. BlackPill improves health outcomes by 1 QALY over best supportive care (BSC), but costs $500,000 over the patient’s lifetime. While not cost effective by traditional standards,…