The FDA: A Spoonful of Safety Makes The Medicine Go Down

Unbiased Science

@unbiasedscipod

Education, Science, Health & Fitness

4.4 • 644 Ratings

🗓️ 25 October 2023

⏱️ 52 minutes

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Summary

On this week's episode of the pod, we are talking about a drug that's been available for decades but is suddenly being pulled from shelves: phenylephrine (something you've probably reached for when you've been congested). We bring on an expert, Dr. Mikkael Sekeres, a Professor of Medicine and Chief of the Division of Hematology at the Sylvester Comprehensive Cancer Center at the University of Miami who formerly chaired the Oncologic Drugs Advisory Committee of the FDA. Dr. Sekeres helps us walk through the history of the FDA's regulation of the safety and effectiveness of drugs. We discuss some other notable examples throughout history that demonstrate the evolution of the regulatory agency. We know this is a very hot topic and we hope you'll tune in to better understand how the FDA operates. You definitely don't want to miss this! Interested in advertising with us? Please reach out to advertising@airwavemedia.com, with “Unbiased Science” in the subject line. PLEASE NOTE: The discussion and information provided in this podcast are for general educational, scientific, and informational purposes only and are not intended as, and should not be treated as, medical or other professional advice for any particular individual or individuals. Every person and medical issue is different, and diagnosis and treatment requires consideration of specific facts often unique to the individual. As such, the information contained in this podcast should not be used as a substitute for consultation with and/or treatment by a doctor or other medical professional. If you are experiencing any medical issue or have any medical concern, you should consult with a doctor or other medical professional. Further, due to the inherent limitations of a podcast such as this as well as ongoing scientific developments, we do not guarantee the completeness or accuracy of the information or analysis provided in this podcast, although, of course we always endeavor to provide comprehensive information and analysis. In no event may Unbiased Science or any of the participants in this podcast be held liable to the listener or anyone else for any decision allegedly made or action allegedly taken or not taken allegedly in reliance on the discussion or information in this podcast or for any damages allegedly resulting from such reliance. The information provided herein do not represent the views of our employers.

Transcript

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0:00.0	You're listening to an Airwave Media podcast.
0:19.7	Welcome to Unbiased Science, where we bring scientific method to the madness.
0:25.6	We're your hosts, Dr. Jessica Steyer.
0:27.9	And Dr. Andrea Love.
0:29.5	And this week, we are joined by a very special guest to discuss something that's been
0:35.1	splashed all over the news lately, all over the headlines,
0:39.1	something that you probably have in your medicine cupboard right now that you reach for when
0:44.7	you're stuffed up or congested. We'll talk more about that in a moment. Phenalephrin,
0:49.2	or phenylephrin, depending on who you ask. And this is going to be wrapped up in a larger
0:54.0	conversation about the FDA approval process, because we know you ask. And this is going to be wrapped up in a larger conversation
0:54.8	about the FDA approval process, because we know you have a lot of questions. We are joined
1:00.6	today by Dr. Mikhail Sekaris, who is chief of hematology at the University of Miami's
1:06.8	Sylvester Comprehensive Cancer Center, and author of the book, Drugs and the FDA.
1:13.1	He earned his medical degree and a master's degree in clinical epidemiology from the
1:18.9	University of Pennsylvania School of Medicine. Dr. Seckeres completed his post-grad training
1:24.1	at Harvard University, finishing an internal medicine residency at Mass General
1:28.8	Hospital and a fellowship in hematology oncology at the Dana-Farber Cancer Institute in Boston.
1:36.3	He chaired the Oncology Drugs Advisory Committee of the FDA, has been on the editorial boards
1:43.1	for several medical journals and shares scientific
1:46.3	advisory boards for patient advocacy groups and research funding agencies. So we came to learn of Dr.
1:53.6	Seckeres because we read this amazing piece in Vox, which we will hyperlink. Mikhail, we're going to
2:00.0	call him by his first name.
	...

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