Let's bring some science into all this talk about #medetomidine. 🧵

TLDR: Expect unexpected sedation.

We predicted it would soon emerge in illicit supply, and @US_FDA agreed, and so we have this grant to investigate its pharmacology, etc. @nanopharmNC

fda.gov/science-resear… We first observed #medetomidine in NC in a sample collected in October 2022, in Raleigh. Combined with xylazine, and traces of fentanyl and meth. @LunaJBear
streetsafe.supply/results/p/3004…

1 🚨Attention please: Turns out #xylazine is a kappa opioid. This validates experience from frontline folks and PWUD. Fresh science from collaborators @nanopharmNC @MadiganLBedard @zenbrainest
Pre-print:
Public health 🧵 below
#TwitteRx #harmreductionbiorxiv.org/content/10.110… Check out @nanopharmNC's explainer on the lab science. I'll breakdown the #publichealth implications.

https://twitter.com/nanopharmNC/status/1700595751397605528?s=19

Let's talk #nalmefene for OD reversal, an old generic drug in new expensive clothes. FDA approved Rx-only nasal spray today. Will this help prevent overdose deaths in the fentanyl-xylazine-strongbenzo era?

🧵👇

fda.gov/news-events/pr… Nalmefene was developed in the 1980s by erstwhile Key Pharma in Miami, with help from scientists at @UVA
europepmc.org/article/med/39…

Based on our lab data, I reckon #xylazine shows up in the drug supply 5 specific ways:
🧵👇 1. Veterinary diversion is rare, niche, and localized to interconnected Caribbean communities:

Philly

https://twitter.com/moraffreports/status/1541826000941711361?s=20

Puerto Rico
link.springer.com/article/10.118…

Y'all ready for this? 🍿👊
#NarcanAdCom about to pop off
Use this # to follow today's updates

CONCEPT
The culmination of 2 decades of advocacy to make naloxone OTC

REALITY
2 decades of advocacy erased by overdose crisis profiteers $EBS

Right out the gate, FDA frames this as a solution for saving kids from overdose. Guess that’s why there are so many pediatric anesthesiologists on the AdCom

🚨 Something huge happened today. 🚨

@US_FDA @DrCaliff_FDA listened to harm reduction programs and made it infinitely easier to purchase #naloxone in bulk. With 100,000+ overdose deaths each year, we need BIG solutions.

w/@RemedyAlliance @ejwheeler9 @coreysdavis
🧵 1/26 @US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis The FDA Guidance provides clear federal support for bulk purchase and distribution of naloxone to meet one of the biggest public health challenges of our times.

Full text via link below, but let's break it down.

https://twitter.com/FDA_Drug_Info/status/1572947464793083912?s=20&t=8PucNNbFN9Pf-qjBchCzrg

2/26

“There are a lot of abandoned people who were on pain medications, who cannot get access to adequate pain management anymore, and are therefore, increasingly, turning to the street. We hear those stories every day.”

time.com/6214811/overdo… Thanks to @ibdgirl76 @LelenaPeacock and others who have shared with me many stories about abandoned CPP. This article from @TaraLaw27 is a solid starting point to recentering folks in pain who can’t get the help they deserve.

To initiate over-the-counter status for prescription drugs, FDA prioritized *anti-flatulent drugs* and *ingrown toenails* over life-saving antidote naloxone. I daresay preventing 93,000 overdose deaths should have been first. 🧵 with Maya & @ejwheeler9
accessdata.fda.gov/scripts/cder/o… @ejwheeler9 We have an incredible opportunity. A generic pharma is willing to make a harm reduction-only naloxone. They have filed for the new NDC. If we have an injectable naloxone that can only be accessed by syringe exchange programs, why do we need the antiquated Rx requirement?

Finally attention to xylazine. But these reports miss the point because they aren’t actually talking to people who use drugs.

Xylazine in dope is intentional. PWUD like it because it holds of withdrawal. Yet it may cause fatal iron depletion.

cdc.gov/mmwr/volumes/7… There appears to be some mu opioid agonism, or similar pathway that prevents withdrawal without causing an opioid high. (Tho usually mixed with fentanyl.

We are unveiling new findings about MME/day calcs for #opioids @US_FDA Workshop today. Live blogged in thread below.

Lab notebook, code, equations:
opioiddata.org/studies/equati…
With @chris_delcher @yanningwang @AlanKinlaw @ToskaCooper @BrookeChidgey
#epitwitter #RxEpi #medtwitter @US_FDA @chris_delcher @yanningwang @AlanKinlaw @ToskaCooper @BrookeChidgey Apologies in advance... this is experimental live blogging... sometimes twitter scrambles images on long threads

== 8 tips for bringing people with lived experience into health research ==
Applies equally to patients with chronic pain and people who use drugs.
Thread below from my presentation today at #NCOpioidSummit @OpioidSummit
OpioidPreventionSummit.org with @nc_usu @OpioidSummit @nc_usu Here's our shared big goals: Generate the best information and reduce drug related harm.

Does naloxone help with xylazine-heroin-fentanyl overdose? Great question from @JessTilley7

Thread below on what we do and don't know from the scientific lit with @mary_figgatt @WeezieBeale @nc_USU

Would love @VetFinals to provide clinical insight too @JessTilley7 @mary_figgatt @WeezieBeale @nc_usu @VetFinals 2. At issue is this flyer where we say "Naloxone works on opioids. It may work on xylazine, but the evidence is unclear. Always use naloxone in the event of an overdose."

https://twitter.com/nabarund/status/1381694109216165891?s=20

I'm seeing epidemiologists make a logical fallacy about the COVID vax + blood clots. Saying the risk (or rate) is "1 in a million" = misleading
Here’s a quick breakdown on how to do better by #pharmacovigilance (PV) stats
Audience: #epitwitter #datascience #RxEpi 2/ Comparing to birth control risks isn't proper. The *type* of clot is different. But also, quantified risk of clots from The Pill are from studies where each patient was assessed for the outcome (side effect). That's not so with COVID vaccine data now

https://twitter.com/nabarund/status/1382006242680438786?s=20

Xylazine, a veterinary tranquilizer, is showing up in heroin and other dope today.

🚨 xyalzine is NOT levamisole 🚨

Pay attention, this is something different. A brief 🧵 timeline below by @mary_figgatt @UNCpublichealth @UNC_IPRC 1962- xylazine synthesized by Bayer in Germany, possible medicine for high blood pressure in humans
doi:10.1136/vr.85.19.512

What happened when politicians promoted #hydroxychloroquine as a cure for COVID? People died from unnecessary side effects.

I reviewed the recent data from the Pfizer Global Safety Database in @DrugSafetyJ

link.springer.com/article/10.100…
open access

thread below #pharmacovigilance Original data from Beyzarov et al. in
@DrugSafetyJ

link.springer.com/article/10.100…
(open access)

While this America settles in the mould of its vulgarity, heavily thickening
to empire And protest, only a bubble in the molten mass, pops and sighs out, and the
mass hardens,

Excited for Priya Bahri’s plenary session on #scicomm at #ICPE20 #RxEpi starting at 11:15am ET today

#pharmacoepidemiology @ISPE_Exchange Here we go! #icpe2020

It's been 10 years since #OxyContin was re-engineered to make it hard to crush. But #publichealth benefits are still unclear. Here is a brief video of the epidemiology challenges.

vimeo.com/456967594

As guest speaker at FDA Advisory Committee

#RxEpi
#pharmacoepidemiology A *product-centric* worldview, holds that abuse deterrence is primarily the property of the drug, and that that is the PRIMARY thing that changed with the reformulation, especially in the immediate aftermath.