The rise and fall of a fake decongestant: What phenylephrine tells us about the history of the FDA
Nov 29, 2023
auto_awesome
Deb Chakravarti, a professor with industry experience, discusses the FDA's oversight of phenylephrine in cold medicines. They explore historical cases like thalidomide and Vioxx, while also highlighting new technologies like a capsule to prevent opioid overdose. The episode reveals the complexities of drug approval and regulations, as well as innovative solutions for healthcare challenges.
The FDA's history of drug approval and evolving role influenced the use of phenylephrine in cold medicines.
Reporting drug adverse effects is crucial for FDA to assess safety, as seen in cases like Vioxx.
Deep dives
The Approval Process for Drugs by the FDA
The FDA's advisory panel questioned the efficacy of phenylephrine, a common ingredient in cold medicines, finding it no better than a placebo. The history of drug approval was discussed, including preclinical work, four phases of clinical trials, and the new drug application process. The need for safety and efficacy in drugs has evolved over time, influenced by cases like the Littomide incident.
Phenylephrine's Approval and OTC Drug Monographs
Phenylephrine, approved as a nasal decongestant, faced scrutiny for its oral effectiveness in treating cold symptoms. The FDA uses OTC drug monographs to regulate drug ingredients considered safe and effective without specific approvals. Pharmacists discovered inadequate data supporting phenylephrine's efficacy, leading to further investigations and large clinical trials.
Ensuring Drug Safety and Transparency
The importance of reporting drug adverse effects was highlighted, emphasizing the FDA's role in assessing drug safety and efficacy. A case study on Vioxx revealed the dangers of overlooking safety concerns, leading to its recall. Researchers developed a pill for monitoring vital signs internally, aiming to help prevent opioid overdoses and aid individuals with conditions like sleep apnea.
The FDA drug approval process is known to be a lengthy and rigorous one. But the FDA-approved ingredient phenylephrine — found in common cold medicines like Sudafed, Mucinex, and NyQuil — was recently found to be no better than a placebo. Phenylephrine has been on store shelves for nearly 90 years. How could that happen?
In this episode of Tiny Matters, Sam and Deboki are joined by none other than Deboki's dad, Deb Chakravarti. Deb is a professor with years of industry experience and the current director of the York College FDA Partnership. He helps dissect the FDA's recent findings and how its history and ever-evolving role in the pharmaceutical industry contributed to phenylephrine being used in oral cold medicines for so long.
Deb, Deboki and Sam also unpack pharmaceutical ethics cases, like thalidomide in the 1950s and 60s, and the case of Vioxx in the early 2000s, which led to tens of thousands of deaths.
Sam and Deboki cap off the episode with tiny show and tells about how the nose is really 2 noses (!) and the story of a new, ingestible, vitamin-sized capsule that could protect people from dying of an opioid overdose, sleep apnea, or other conditions that depress breathing.
Check out PNAS Science Sessions here and wherever you listen to podcasts. Links to the Tiny Show & Tell stories are here and here. Pick up a Tiny Matters mug here! All Tiny Matters transcripts are available here.
Get the Snipd podcast app
Unlock the knowledge in podcasts with the podcast player of the future.
AI-powered podcast player
Listen to all your favourite podcasts with AI-powered features
Discover highlights
Listen to the best highlights from the podcasts you love and dive into the full episode
Save any moment
Hear something you like? Tap your headphones to save it with AI-generated key takeaways
Share & Export
Send highlights to Twitter, WhatsApp or export them to Notion, Readwise & more
AI-powered podcast player
Listen to all your favourite podcasts with AI-powered features
Discover highlights
Listen to the best highlights from the podcasts you love and dive into the full episode