Compound Tirzepatide: Time to Stock Up?

Описание: WAYS TO SUPPORT MY WORK ⬇️
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00:00:01 – 00:00:23
Episode agenda preview
• Stocking up on compounded injectable GLP 1 meds
• Zepbound QuickPens via LillyDirect
• Whether the 45 day requirement goes away
• Reddit reports of people trying retatrutide

00:00:46 – 00:01:27
Show intro and mission
• What the show covers, goal is helping people have better doctor conversations
• Calls to like, subscribe, rate the podcast

00:01:27 – 00:08:13
Eli Lilly earnings call takeaways
• Retatrutide timeline and submission plan for obesity, osteoarthritis, obstructive sleep apnea, aiming for availability beginning to mid 2027
• Retatrutide positioned as escalation therapy, not a Zepbound replacement, and likely priced accordingly
• Brinipetide as a next gen GLP GIP, with trials planned in neurological and psychiatric areas (alcohol use disorder, tobacco, bipolar disorder, major depressive disorder)
• Phase 3 trial starting for tirzepatide in type 1 diabetes
• Zepbound QuickPens status, described as launching in coming days, with expectation the 45 day refill requirement drops around spring or aligned with launch

00:08:28 – 00:12:17
Why people are asking about stocking up, the trigger events
• Novo Nordisk earnings call context and Wegovy pill launch performance, 170k prescriptions, mostly starter dose, mostly new therapy patients
• Hims and Hers launches a compounded pill priced at $50 and markets it as the same active ingredient as Wegovy pill
• Explanation of why oral semaglutide is hard, Novo’s absorption technology, low absorption rate, and why “same active ingredient” messaging can mislead on oral bioavailability
• Escalation of reaction from FDA leadership and lawmakers, leading to an FDA letter released Friday

00:12:52 – 00:15:08
FDA letter and what it claims
• FDA intent to take decisive steps to restrict GLP 1 APIs used in non FDA approved compounded drugs that are being mass marketed
• FDA says companies cannot claim compounded products are generic, the same as, or use the same active ingredient as FDA approved drugs
• Framing this as a direct response to Hims and Hers advertising

00:15:08 – 00:23:13
Alliance for Pharmacy Compounding response and what it means for patients
• APC letter to FDA pushes back, argues about prescriber judgment and patient specific care
• APC argues API sourcing framework implies it is the same active ingredient, while also agreeing compounds are not FDA approved and should not be marketed as such
• Discussion of the FDA green list and alleged inconsistency in FDA posture
• Point that enforcement focus appears heavier on regulated compounding versus gray market peptides
• Take that more framework could be good because compounds are still expensive and patients deserve sterility and authenticity
• APC asks FDA to slow enforcement, which is framed as a reason patients should plan continuity of care with their doctor
• Host belief: not an overnight shutdown, but risk of interruption exists

00:21:34 – 00:22:21
Novo also receives an FDA letter
• Bloomberg context that Novo got a letter about Wegovy pill commercials suggesting pills are better than injections
• Framed as FDA reining in marketing on both sides, not just compounding

00:23:25 – 00:25:19
Super Bowl and culture moment around obesity and GLP 1s
• Weight loss ads and obesity narrative during the Super Bowl (Ro, Hims and Hers, Wegovy pill ad)
• Mentions a fat shaming style video and stigma concerns
• Emphasis that obesity is a chronic relapsing disease and creators should be mindful of bias

00:25:20 – 00:30:48
Novo Nordisk lawsuit against Hims and Hers, why it is different
• Lawsuit described as patent infringement, contrasted with the usual trademark or cease and desist pattern
• Argument that some compounders want to challenge peptide patents because these mimic endogenous hormones
• Explanation of why these drugs are patentable in practice, half life engineering, binding affinity, innovation
• Theory that Hims and Hers baited a patent fight through aggressive pill launch messaging and pricing
• Concern about balancing access through compounds with preserving pharma innovation incentives

00:30:49 – 00:31:34
Wrap up and next content teaser
• Lawsuit could take years or settle
• Teases upcoming interview with Dr. Rachel Goldman, an Oprah panelist on the GLP 1 and obesity special
• Final calls to subscribe and share