411: Capricor's data clash and a fugitive in the C-suite

The Read Out Loud episode opens with updates on biotech industry news. Sarepta Therapeutics has appointed Michael Severino as its new CEO, replacing Doug Ingram who led the company through the approval of three Duchenne muscular dystrophy treatments but faced scrutiny over their efficacy and safety. GSK's new CEO Luke Meals is implementing $2.5 billion in cost cuts over three years while increasing late-stage trials from 10 to 20 phase three studies to hit a $53.2 billion sales target by 2031, navigating loss of patent protection on an HIV franchise. The episode addresses Anthony Fauci's Senate testimony where he invoked his Fifth Amendment right regarding COVID-19 origins before a committee headed by Senator Rand Paul.

The main regulatory story concerns an FDA advisory panel's 9-3 vote against approving Capricor Therapeutics' Daromyacel for Duchenne muscular dystrophy treatment in older boys and teenagers. The FDA's blistering critique focused on disagreement over whether the drug met its endpoints. A central point of contention was Capricor's changes to its statistical analysis plans during the study—though before unblinding—which the FDA viewed as problematic. The company submitted multiple statistical plans, with the FDA using the original pre-specified plan, while Capricor used a revised version that presented the data in a more favorable light. Notably, data published in the Lancet the day after the panel meeting revealed the drug was not statistically significant even under Capricor's chosen analysis plan, information that would have changed the discussion had it been known earlier. Hosts discuss the apparent inconsistency with FDA's previous approvals of Sarepta's Duchenne drugs without proven efficacy, questioning whether FDA standards vary across patient populations and leadership eras. The discussion notes that skepticism of Capricor's drug persists among FDA staff even after the departure of controversial former regulator Vinay Prasad, suggesting the rejection reflects broader agency concerns rather than individual leadership preferences.

The episode's second major story involves investigative reporting by Adam Feuerstein on Ronald Fisher, a Rhode Island physician convicted of rape in 2005 who jumped bail and remained a fugitive for over 20 years. He was caught on a sailboat off New Jersey in July 2024 under the assumed identity Richard Graydon. Feuerstein's expanded reporting reveals Fisher operated extensively in the biopharma industry under this false persona, working as a contractor for Takeda Sankyo for three years (2016-2019), serving as interim chief medical officer at Atassa Therapeutics, becoming chief medical officer of IMIX Biopharma, and working with Bristol Myers Squibb and Johnson & Johnson. His fabricated CV claimed a Stanford medical degree, Harvard training, and board certification as a hematologist-oncologist, when he was actually an anesthesiologist. A healthcare recruiter who interviewed "Graydon" multiple times beginning in 2020 for a Bristol Myers Squibb position noted his credentials placed him at the top of candidate lists. Background checks appear to have been insufficient—companies claimed to conduct them but missed obvious red flags like fake degrees and mismatched Social Security numbers. Fisher's home address listed on his CV was actually a UPS store in lower Manhattan. The yacht's registration used the Graydon alias, and he may have listed a Manhattan address while actually living on the boat. Feuerstein reports speaking with someone who sailed with Fisher in 2024, indicating he wasn't living exclusively on the vessel during all his fugitive years.

The episode concludes with announcement that producer Hyacinth Empanada is leaving for The Conversation, a nonprofit news outlet, to become global health video producer. The hosts express gratitude for her work since the podcast's inception in March 2018 and her contributions during COVID coverage. The Read Out Loud will take a hiatus for August and return in September.