Lee Rosebush

@JCanNuSH @ZachShurtleff We didn’t stay with just manufacturing. We went straight to clinicians and pharmacists as well. Then, we reviewed poison control center data and public records even with the risk of duplication

I do question to what degree these manufacturers solicited adverse event data from their patients and how a patient would even know to which manufacturer they should report their issues, given the non-traditional manner in which these meds are currently being distributed. How many patients know the manufacturer of their peptide product and are they even reliably labeled so that patients can report those issues? In addition, with no prescribers are involved, I’m uncertain to what degree anyone is actually motivated to do the reporting. Can these manufacturers state unequivocally that whatever they shipped was fully labeled and not repackaged down the road to obscure the original source? Does the packaging provide info on a point of contact for adverse event reporting? I’m also doubtful many patients would even consider checking with the poison control center for a med they know is unapproved/unlicensed, etc. This seems to be the lone sentence in the matter in AAPM’s executive summary on their package: “In addition, AAPM engaged Aquila Health to review public poison control records associated with peptides; in a sample of approximately 30,000 records, the review identified NO adverse events associated with the substances under consideration.” Ultimately, no information on the criteria used to identify the 30,000 samples and reviewed poison control records is given. Were these any records at all involving “peptide” or just a random selection of 30,000 records? What dates were included? No idea.

People keep saying there’s “no evidence” for the peptides voted on at PCAC. The real-world data, the patent problem, and why compounding is a complementary system (not a rogue challenge to the FDA) are all in this piece. This is bigger than just a vote. x.com/i/article/2081…

@JR_Lang @JCanNuSH @ZachShurtleff Thank you. Check out pharmacyaccreditation.com for even more on the topic. We are working with NABP and various members from state boards of pharmacy to address even more.

There is no doubt adverse events are grossly underreported, but it’s tough to do any better when it’s operating outside of the current legal framework. There is a certain subset of AEs that come even with placebo. I was thoroughly impressed that @LeeRosebush was able to compile that dataset for the FDA and PCAC.

Thank you @NEWSMAX for having me on this morning and discussing peptides! newsmax.com/newsmax-tv/con…

Not just a pricing question but also about to serve individual patient and provider needs! Thank you @WSJ for this perspective! wsj.com/opinion/the-fd…

350,000+ Semax doses. Zero adverse events in the analysis. At the FDA’s PCAC hearing, Lee Rosebush, chair of AAPM, said the organization’s retrospective analysis reviewed more than 350,000 doses and returned zero adverse events. Important context: this was evidence reported by AAPM during public testimony, not an FDA finding or proof that Semax carries no risk. @LeeRosebush

@JGdeIx17 @JR_Lang @DrJesseMorse @PeptideBase @DrAlexTatem @ferrisbuhler81 Or, worse didn’t review the science or information provided to them before the deadline.

@JR_Lang @DrJesseMorse @LeeRosebush @PeptideBase @DrAlexTatem @ferrisbuhler81 Yeah but on the flip side, I’d rather have a predetermined “yes” from a clinician who actually prescribes these therapies and sees patient outcomes every day than a predetermined “no” from someone with no clinical experience in peptide medicine.

The voting for which way a person would vote for the PCAC’s committee peptide meeting was pretty obvious, especially since I was physically in the room. @PeptideBase created a beautiful tracker that makes it obvious. The clinicians who see patients regularly and have experience with peptides, including understanding the issues with the gray market, for the most part voted yes. Nearly all the pharmacists and non-clinicians voted against. They were focused on the wrong things. Do the peptides work? A small random study from 30 years ago with conflicting variables. Many of them didn’t even include the massive 30+ years worth of data regarding multiple peptides because it was completed in Russia/Soviet Union, and they ‘didn’t trust translation.’ 🤣 Multiple people who voted no, in their explanation thereafter, admitted the reason they voted no was because the peptide didn’t seem very effective. The problem is, they were repeatedly told that that was not an inclusion criteria. This vote was about safety and access. Not about efficacy. Don’t like the compound? Don’t prescribe it. But to completely remove access from the American people because you don’t think it works well is just selfish. Wouldn’t be surprised if many of the ‘no’s’ are Big Pharma employees. For many of them I don’t even think they listened to a single thing the presenters said. Their vote was no before they even arrived in the room. Nonetheless the ‘good guys’ prevailed. Congrats @LeeRosebush @ferrisbuhler81 @DrAlexTatem and the many others for your hard work and ability to deliver clear, understandable facts. The United States is in a better place now as a result. Excited to see the next steps unfold.

Several have asked, what are the questions I should be asking if I am interested in Peptides? Well, @ferrisbuhler81 and I, along with @tonylyonspub have you covered. Check out The Peptide Revolution: Past, Present, and Future a.co/d/083Xfx6v if you are truly interested in this hot topic.

Millions of patients will benefit from what Lee and American Academy of Peptide Medicine members accomplished this week. This win didn’t just happen. It took countless hours over YEARS with no promise of success. Contributing my small part was an honor. God bless America.

@MitchT42 Thank you brother. Scary how far we have come from those Mishawaka roots!

I have known Lee for over 30 years. Lee is the chairman of the American Academy of Peptide Medicine. If you’re interested in peptides and their legal status, give him a follow @LeeRosebush

@DrAlexTatem Thank you brother. Your presentations the last 2 days were unreal. This doesn’t happen without you. I am so proud to work with you on this. This is just the beginning!

GLP-1s (NuSH peptides) are just one pathway for fighting obesity. For those who have already redlined those pathways and still struggle to keep the disease at bay, the future lies in targeting additional biological pathways. Optimizing metabolic and mitochondrial function may be just as important as targeting insulin and appetite. Ask me how I know. Kudos to @LeeRosebush and @ferrisbuhler81 Et al for getting their hands dirty in this fight for patients. I know this app gets hung up on the economics of it all, but for patients, this week was a huge deal.

There are a lot of narratives of what happened the last 2 days at the FDA’s PCAC hearing. This video sums it up perfectly. I have literally fought with blood, sweat and tears for years to get to this moment. And, I admit, I cried listening to this.

@AbudBakri Completely agree

@LeeRosebush 100% As long as state medical boards don’t get too aggressive…

The drug approval process doesn’t meet the current population it seeks the protect. This is what people are missing The current model of is designed to approve drugs to treat specific conditions How do you get drugs approved that are.. to improve performance and “wellness”, whatever that means to you. SS-31 got approved for a rare condition but millions more doses will be used for “mitochondrial health” Tesamorelin is approved for HIV lipodystrophy but actual usage is in the performance space These were glitches that get drugs through We need a process to get safe usage of performance and longevity medicine compounds. Not just this batch of peptides There will be hundreds more A regulatory space needs to develop

Semax approved. 6/7. I’ll take it.

Today the FDA's Pharmacy Compounding Advisory Committee recommended Semax for inclusion on the 503A Bulks List, choosing patients over the status quo. It's a recommendation, not the final step, but it moves safe, legal, pharmacy-based access one step closer for the patients and providers who've been asking for it. This is medical freedom in action.

Day 2 PCAC Update: The FDA’s Pharmacy Compounding Advisory Committee voted 7–4 (with 1 abstention) to recommend Epitalon for inclusion on the FDA’s 503A Bulk Drug Substances List following its review for insomnia. This is an important milestone, but it’s not the final step. The recommendation is advisory, and the FDA must complete the formal rulemaking process before licensed pharmacies can compound with Epitalon.

FDA Compounding Advisory Committee Update (Day 2) The Committee voted 6–7 (1 abstention) against recommending Emideltide (DSIP) for the FDA’s 503A Bulk Drug Substances List, a one-vote difference. What this means: The Committee’s recommendation is advisory only. The FDA makes the final decision through its formal rulemaking process. What it doesn’t mean: Emideltide is not banned. This vote does not make it unlawful or change its current regulatory status.

Another huge step for medical freedom!! Semax is a yes!!!! 6 of 7…major steps for patients and providers!