Plenary Session - inactive due to federal service - podcast cover

Plenary Session - inactive due to federal service

Vinay Prasad, MD MPHsoundcloud.com
Dr Prasad currently serves as the Director of the Center for Biologics Evaluation and Resesarch (CBER) at the US FDA. The audio on this platform were posted before my FDA employment and do not necessarily represent the views of the FDA or the United States. This site will be inactive during my federal service. A podcast on medicine, oncology, & health policy. Host: Vinay Prasad, MD MPH from University of California San Francisco. Tweet your feedback to @Plenary_Session or e-mail [email protected]
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Episodes

1.66 Employing Medical Writers & Frequentist vs Bayesian Methods with Dr. Allen Pannell

This week we open with a critical take on our current system of disseminating scientific research, specifically focusing on the prevalence of -- and dependence on -- medical writers. In the second half of the episode, we interview Dr. Allen Pannell of the Haslam College of Business at the University of Tennessee on using a Frequentist approach vs a Bayesian approach in the context of a single clinical trial. Frequentist vs Bayesian: doi.org/10.1136/bmjopen-2018-024256 Dr. Pannell's breast cancer...

Jun 20, 20191 hr 4 min

1.65 BONUS! Focusing and Building Your Presence on Twitter

In this BONUS episode we give advice on how to use Twitter effectively: how to focus your content, how to build your Twitter following, and how to conceptualize of the platform as an information network. Back us on Patreon! www.patreon.com/plenarysession

Jun 12, 201940 min

1.64 Effectiveness of Cancer Screening with Dr. Joaquín Chapa and POLO with Dr. Emerson Chen

This week we discuss the recent paper "Interpreting the Effectiveness of Cancer Screening From National Population Statistics: Is It Sound Practice?" with its author, Dr. Joaquín Chapa of OHSU. We then revisit the POLO trial with Dr. Emerson Chen of OHSU, who disagrees with last episode's analysis. Effectiveness of Screening: doi.org/10.1016/j.mayocp.2019.02.016 POLO: doi.org/10.1056/NEJMoa1903387 Back us on Patreon! www.patreon.com/plenarysession

Jun 06, 20191 hr 8 min

1.63 POLO, TITAN, & from ASCO: FDA Approval, Surrogate Endpoints, and Patient Experience

This week we cover some of the highlights from this year's ASCO annual meeting. We discuss the POLO study "Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer" and the TITAN study "Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer", both recently published in NEJM. We end with a presentation titled "Expedited Program Use and Patient Experience in Trials", which was given in a shortened version at ASCO. POLO: doi.org/10.1056/NEJMoa1903387 TITAN: doi.org/10.1...

Jun 04, 20191 hr 23 min

1.62 Rates of Cancer Screening, BILCAP Outcry, Waterfall Plots and Response Rate, & Dr. Jeff Sharman

We begin this episode by responding to listener feedback from episode 1.61's discussion of clinic appointment time and rates of cancer screening. We also tackle listeners' outcry over our take-down of BILCAP (spoiler alert: BILCAP is still a null trial) and how outcry like this highlights the need to train clinicians to think probabilistically. From there, we move on to discussing the recent paper by Myung Sun Kim in JAMA Network Open on waterfall plots and how they are a visual distortion of re...

May 23, 20191 hr 32 min

1.61 Postpublication Metrics of RCTs, PCP Appointment Time, Bortezomib, & Dr. Christopher Booth

This week we cover three papers -- "Postpublication Metrics of Randomized Clinical Trials With and Without Null Findings" by Murray et al. in JAMA, "Association of Primary Care Clinic Appointment Time With Clinician Ordering and Patient Completion of Breast and Colorectal Cancer Screening" by Hsiang et al. in JAMA Network Open, and "Exceptional responders with invasive mucinous adenocarcinomas: a phase 2 trial of bortezomib in patients with KRAS G12D-mutant lung cancers" by Drilon et al. in Mole...

May 15, 20192 hr 35 min

1.60 I-PREDICT, Flawed Phase I Trials, & the Cost of Drugs with Dr. Daniel Hartung

We revisit I-PREDICT, discuss the "Imputability of Adverse Events to Anticancer Drugs" (a letter published recently in the New England Journal of Medicine), and interview Dr. Daniel Hartung of Oregon State University's College of Pharmacy on his vast knowledge of the cost of drugs, specifically addressing Acthar gel and multiple sclerosis drugs. Imputability of Adverse Events: doi.org/10.1056/NEJMc1900053 Back us on Patreon! www.patreon.com/plenarysession

May 09, 20191 hr 20 min

1.59 BONUS! Should Evidence Come with an Expiration Date? with Palmer Greene

In this BONUS episode, we interview Palmer Greene, a fourth-year medical student at the University of Chicago Pritzker School of Medicine, on his recent paper: "Should Evidence Come with an Expiration Date?", published in the Journal of General Internal Medicine. Expiration Date?: doi.org/10.1007/s11606-019-05032-4 Back us on Patreon! www.patreon.com/plenarysession

May 08, 201919 min

1.58 Magic Mouthwash with Dr. Arjun Gupta & Precision Oncology with Dr. Talal Hilal

This week we discuss three paired papers on precision oncology published in Nature Medicine and then, later in the episode, go in-depth on the implications of these negative studies with Dr. Talal Hilal of the Mayo Clinic. We also discuss the use of magic mouthwash for oral mucositis with Plenary Session fan, Dr. Arjun Gupta of Johns Hopkins University. WINTHER: doi.org/10.1038/s41591-019-0424-4 TARGET: doi.org/10.1038/s41591-019-0380-z I-PREDICT: doi.org/10.1038/s41591-019-0407-5 Magic mouthwas...

May 07, 20191 hr 34 min

1.57 BONUS! Control Arm Quality in RCTs Leading to Anticancer Drug FDA Approval with Dr. Talal Hilal

In this BONUS episode, we interview Dr. Talal Hilal of the Mayo Clinic on his paper that was published today in JAMA Oncology, titled "Analysis of Control Arm Quality in Randomized Clinical Trials Leading to Anticancer Drug Approval by the US Food and Drug Administration". Control Arm Quality: doi.org/10.1001/jamaoncol.2019.0167 Back us on Patreon! www.patreon.com/plenarysession

May 02, 201934 min

1.54 Association of Patient Characteristics and Tumor Genomics with Clinical Outcomes & SABR-COMET

In this week's episode, we break down two recently published papers. The first is "Association of Patient Characteristics and Tumor Genomics With Clinical Outcomes Among Patients With Non–Small Cell Lung Cancer Using a Clinicogenomic Database" by Singal et al., published in JAMA. The second is "Stereotactic ablative radiotherapy versus standard of care palliative treatment in patients with oligometastatic cancers (SABR-COMET): a randomised, phase 2, open-label trial" by Palma et al., published i...

Apr 18, 201934 min

1.53 CALGB 50303, REMoDL-B, & REMS, Orphan Drug Act, and Role of the FDA with Dr. Ameet Sarpatwari

We begin this episode with a discussion of two recent clinical trials in lymphoma: CALGB 50303 and REMoDL-B, respectively published in the Journal of Clinical Oncology and The Lancet Oncology. We include a primer on the history of lymphoma and the development of R-CHOP. We follow that with an in-depth interview with Dr. Ameet Sarpatwari of the Harvard Medical School on Risk Evaluation and Mitigation Strategies (REMS), the Orphan Drug Act, and, broadly, the purpose of the US FDA. CALGB 50303: doi...

Apr 11, 20191 hr 46 min

1.52 BILCAP & DOACs for Thromboprophylaxis in Patients with Cancer with Dr. Sven Olson

In this week's episode we critique the statistics of the recent trial "Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study" that was published in The Lancet Oncology. Then, with Dr. Sven Olson of OHSU, we break down the two papers published in NEJM on thromboprophylaxis with direct oral anticoagulants (DOACs) for patients with cancer: "Rivaroxaban for Thromboprophylaxis in High-Risk Ambulatory Patients with Cancer...

Apr 04, 20191 hr

1.51 BONUS! Study Time Reduction Using Surrogate End Points with Dr. Emerson Chen

In this BONUS episode, we sit down for a quick interview with Dr. Emerson Chen of OHSU on his recent paper in JAMA Internal Medicine on how using surrogate end points as opposed to overall survival for FDA approval for oncology drugs only results in a reduced drug development time of approximately 11 months. Study Time Reduction: doi.org/10.1001/jamainternmed.2018.8351 Back us on Patreon! www.patreon.com/plenarysession

Apr 02, 201926 min

1.50 Replacing RCTs, Physicians on Twitter, Open-Access, & Orthopedics with Dr. Kathryn Schabel

This week we tackle the recent paper published in the Journal of Clinical Oncology titled "Comparison of Population-Based Observational Studies With Randomized Trials in Oncology" as well as a couple papers lamenting physicians' use of Twitter and the open-access model for journal publishing. We end the episode with an in-depth interview with Dr. Kathryn Schabel of OHSU on orthopedic surgery and how she practices. Observational Studies vs RCTs: doi.org/10.1200/JCO.18.01074 Back us on Patreon! ww...

Mar 29, 20191 hr 56 min

1.49 Student Questions, Boeing 737 Max, Pancreatic Surveillance, Leukemia Drugs with Dr. Elihu Estey

We begin this episode by answering questions from a med student who is a Plenary Session fan. We transition from there to a discussion of the recent news stories on the FAA's handling of the Boeing 737 Max controversy and how this reflects on other USA regulatory agencies like the FDA. After a critique of the recent paper "Deleterious Germline Mutations Are a Risk Factor for Neoplastic Progression Among High-Risk Individuals Undergoing Pancreatic Surveillance" published in the Journal of Clinica...

Mar 22, 20191 hr 55 min

1.48 Falsified Data in Meta-Analyses and the Expert Halo Effect with Dr. Stephanie Halvorson

This week we dive deep into an article in JAMA IM on falsified data in meta-analyses. We also discuss the recent JAMA viewpoint "Reducing the Expert Halo Effect on Pharmacy and Therapeutics Committees" with its author, Dr. Stephanie Halvorson of OHSU. Falsified data: doi.org/10.1001/jamainternmed.2014.7774 Expert Halo Effect: doi.org/10.1001/jama.2018.20789 Back us on Patreon! www.patreon.com/plenarysession

Mar 13, 20191 hr

1.47 BONUS! Medical Reversal: Class Lecture

This BONUS episode is a lecture on medical reversal that was pre-recorded for a class at Harvard Medical School. The recording was played for students in February of 2019 and followed by a Q&A. The slides referenced are available to Patreon supporters. Back us on Patreon! www.patreon.com/plenarysession

Mar 11, 201957 min

1.46 BONUS! Personal Finances with Dr. Tom Beer

In this bonus episode, we bring back Dr. Tom Beer of OHSU from episode 1.33 to discuss how to manage your personal finances. The interview is aimed at young physicians, but there is something for all audiences as we cover a broad range of topics: paying off loans, optimizing retirement savings, buying a home, and investing. Back us on Patreon! www.patreon.com/plenarysession

Mar 08, 20191 hr 17 min

1.45 Real-World Data, Gottlieb, & Using the EHR for Meaningful Improvement with Dr. Deborah Cohen

This week's episode begins with praise for the recent article by Booth CM, Karim S, and Mackillop WJ on real-world data published in Nature Reviews Clinical Oncology. Next, we tackle the resignation of Scott Gottlieb as FDA commissioner and how we can measure the success of the FDA. Finally, we have an interview with Dr. Deborah Cohen of OHSU on effective communication between the clinician and the patient and how we can use data from the Electronic Health Record to make meaningful improvements ...

Mar 06, 201959 min

1.44 BONUS! Screen Time and Children's Performance

This BONUS episode is the recording of a lecture given as part of the medical school class Appraising Medical Literature, taught at OHSU. This clip from the class critiques the recent JAMA Pediatrics paper "Association Between Screen Time and Children’s Performance on a Developmental Screening Test". Screen Time: doi.org/10.1001/jamapediatrics.2018.5056 Back us on Patreon! www.patreon.com/plenarysession

Mar 01, 201947 min

1.43 Andexanet Alfa with Dr. Tom Deloughery & National Medicaid Policy with Dr. John McConnell

In this episode we discuss the controversy over the recent article in NEJM, "Full Study Report of Andexanet Alfa for Bleeding Associated with Factor Xa Inhibitors", with Dr. Tom Deloughery of OHSU. We end with an interview with Dr. John McConnell, also of OHSU, on health economics and Medicaid. Andexanet Alfa: doi.org/10.1056/NEJMoa1814051 Back us on Patreon! www.patreon.com/plenarysession

Feb 22, 20191 hr 42 min

1.42 Caplacizumab for TTP with Dr. Sven Olson & Economics of Drug Pricing with Dr. Inma Hernández

In the first half of this episode, Dr. Sven Olson of OHSU joins us to help critique the recent NEJM paper, "Caplacizumab Treatment for Acquired Thrombotic Thrombocytopenic Purpura". In the second half, we interview Dr. Inmaculada Hernández of the University of Pittsburgh on her work on the economic principles behind runaway drug prices. Caplacizumab: doi.org/10.1056/NEJMoa1806311 Back us on Patreon! www.patreon.com/plenarysession

Feb 13, 20191 hr 17 min

1.41 Geneva Oath and Financial Relationships Among Guideline Authors with Dr. Joshua Niforatos

We feature two interviews this week: the first is a hallway conversation with [soon-to-be] Dr. Antonious Hazim of OHSU on the Declaration of Geneva and the second is a discussion with [soon-to-be] Dr. Joshua Niforatos on his recent paper in The American Journal of Emergency Medicine, titled "Financial relationships with industry among guideline authors for the management of acute ischemic stroke". Financial relationships: doi.org/10.1016/j.ajem.2019.01.037 Back us on Patreon! www.patreon.com/ple...

Feb 09, 201957 min

1.40 The World of Hematology with Dr. Thomas Deloughery

This episode features an interview with hematologist Dr. Thomas Deloughery of OHSU. We cover a broad range of topics including 23andMe, wilderness medicine, academia, and Twitter. We'll be back next week with our regular introductory monologue! Back us on Patreon! www.patreon.com/plenarysession

Feb 06, 20191 hr 5 min

1.39 Looking Back On a Tenure in Medicine with Dr. Alex Denes

In this episode we interview Dr. Alex Denes of OHSU on his decades-long career in medicine: what practices have changed and what have stayed the same. No monologue this week - we'll be back next week with more insights! Back us on Patreon! www.patreon.com/plenarysession

Feb 02, 20191 hr 4 min

1.38 Lartruvo, New Directions for Cancer Trials, Gene Expression Profiling, & Dr. Miriam Knoll

In this episode we tackle Eli Lilly's drug Lartruvo (olaratumab) and the under-powered phase II trial that led to its FDA accelerated approval; a viewpoint in JAMA on new directions for cancer trials; and gene expression profiling for carcinoma of unknown primary. We end with an interview with Dr. Miriam Knoll of Hackensack Meridian Health on employment after residency or fellowship, residency training, and the medical specialty pipeline. Back us on Patreon! www.patreon.com/plenarysession

Jan 26, 20191 hr 38 min

1.37 BONUS! Medical Reversal for a General Audience

This BONUS episode is the recording of a talk given at the Salem City Club on January 11, 2019. It's the talk on medical reversal that has been featured in previous episodes, but this time the format and content have been updated for a broader, more general audience. Back us on Patreon! www.patreon.com/plenarysession

Jan 18, 201944 min
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