On this episode of the podcast, Bob and Kate, filling in for Terry, discuss the attack on Food and Drug Administration accelerated approvals. They point to the recent criticism of the breakthrough Alzheimer’s drug Aduhelm as Exhibit A.
Bob explains how accelerated approvals were introduced during the height of the AIDS crisis. He highlights how accelerated approvals allow drugs to be approved via surrogate biomarkers, yet drugs still must meet final criteria to gain full approval. Kate notes how accelerated approvals are reserved for severe diseases with no therapeutic options. Kate argues that the potential dangers of accelerated approvals must be weighed against the fact that patients face rapidly advancing diseases.
Dr. Paul Langley weighs in on ICER’s recent report on Aduhelm, highlighting how the group invents evidence and uses flawed projections to achieve its conclusion on cost-effectiveness. Bob and Kate discuss the problems with ICER’s Quality of Life Years (QALY) model, which discounts individual patient experiences and allows ICER to project the veneer of objectivity.
Bob interviews Nick Adkins of Pinksocks Life, a charity that gifts love and kindness in the form of pink socks worldwide to drive awareness for rare diseases, patient care, and patient advocacy. Nick illustrates how unconditional gifts can make patients feel seen and make a big difference for patients.
Cancer rights attorney Monica Bryant discusses the shortcomings with the Family Medical Leave Act (FMLA), including how it only entitles people to 12 weeks of unpaid time off work and the significant barriers needed to access it. She highlights how one of the positive outcomes of the pandemic is how it has demonstrated the need to expand paid leave. She addresses the ongoing federal efforts to broaden FMLA and make it similar to the concept of unemployment insurance. And she argues that there’s bipartisan support for this reform and calls on ordinary Americans to tell their stories to support it.