Latest / Peptides Weekly / Ep 7: A coroner links a 75-year-old's cardiac arrest to CJC-1295 and ipamorelin.

Transcript

Ep 7: A coroner links a 75-year-old's cardiac arrest to CJC-1295 and ipamorelin. · Peptides Weekly

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  A coroner links the 75-year-olds cardiac arrest to CJC-1295 and Ipa Morellin. This is Peptides Weekly,
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  episode 7, education and evidence, never-dosing advice. After that finding, a U.S. enforcement
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  change on six unapproved peptides, two company diabetes reports, then compounding copies
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  and what published checks actually show. Richard Norton was an Australian actor, stuntman,
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  and fight choreographer. The Guardian reports he went into cardiac arrest in March 2025 after
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  injecting CJC-1295 and Ipa Morellen that a doctor had prescribed even though they were unapproved.
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  Victorian coroner David Ryan treated that sequence as a coronal finding, not as a clinical trial.
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  He was not satisfied those peptides should stay available for medical practitioners to prescribe.
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  In March 2025, Norton asked practitioner Jersey Muchnicki about peptide therapy.
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  The report says they talk through the experimental nature of the treatment, the risks and the absence
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  of therapeutic goods administration approved alternatives.
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  Another practitioner had already prescribed peptides for fatigue, shoulder pain, and
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  loss of muscle mass.
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  Blood tests checked baseline health and contraindications.
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  Norton signed a consent form that listed anaphylaxis among the risks.
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  The injections were prescribed on the 19th of March. Ryan asked the Therapeutic Goods Administration
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  to review benefit and safety. He suggested considering a move from schedule 4, prescription
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  only, to schedule 10, limited to clinical trials or other experimental use. His reason was
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  uncertain therapeutic benefit and safety risks that are not fully known. ABC News frames
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  the death as possibly the first confirmed fatality tied to unapproved peptides. Health and
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  Human Services has now published an enforcement discretion policy.
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  A week after compounding rules were still an open question rather than a finished rule.
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  The BBC reports that Secretary Robert F. Kennedy Jr. released federal registered plans
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  letting compounding pharmacies prepare six peptides the Food and Drug Administration has
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  not approved.
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  Those six are BPC-157, TB-500, KPV, MOT-C, Semmax, and Epitalon.
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  This is a regulatory action, not evidence the drug's work.
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  The draft came from the Health Secretary's Office, not from the FDA.
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  A two-week public comment period follows official publication.
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  An FDA advisory panel voted in July to loosen restrictions, and FDA staff recommended against
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  that step.
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  HHS says it will not pursue state licensed pharmacies, federal facilities, or licensed
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  doctors who compound those six if they meet rules on ingredient quality, manufacturing,
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  monitoring, safety reporting, labeling, and prescriptions written for an individual patient.
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  The policy is temporary while the FDA finishes formal rulemaking on the bulk substance list.
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  Compounders must report serious adverse events and quality problems such as contamination.
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  Compounded drugs are not FDA-approved.
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  Kennedy has called himself a big fan of the drugs and has described using BPC-157 for
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  a muscle injury, which is a personal report, not a study.
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  The partnership for Safe Medicine said the decision leaves a gray area.
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  It said FDA scientists had recommended against the substances because of evidence concerns.
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  It also said many newly appointed pharmacy compounding advisory committee members appear
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  to have conflicts of interest.
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  PSM filed a citizen petition last week urging the FDA to disregard the vote, citing insufficient
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  evidence and arguing the committee was constituted in violation of the Federal Advisory Committee
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  the Act, and the Ethics and Government Act.
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  BBC reporting ads that unregulated injectable peptides are marketed online for unproven
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  uses, including to teenagers, and that experts point to missing human trials and unknown
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  long-term effects.
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  Eli Lilly told Stat its investigational drug Reditrutide was more effective at lowering
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  blood sugar and cutting weight than novel Nordisk's ozempic in a large diabetes study.
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  That is a company report of a head-to-head study in people with diabetes, not a peer-reviewed
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  paper in this week's sources.
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  Retitrutide remains investigational.
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  OZMPIC is the FDA-approved semiglutide brand for type 2 diabetes.
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  Esclidus, in a PR Newswire announcement, reported a placebo-adjusted HBA-1C reduction of 1.7
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  percent at 12 weeks for ASC-30.
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  ASC-30 is an investigational oral small molecule GLP-1.
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  not a peptide. The setting was a U.S. Phase II study in participants with diabetes, and
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  the material here is the company announcement, not an independent journal report. MedScape
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  reports that hair loss associated with GLP-1 receptor agonists appeared similar by race.
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  That framing is an observational association, not a randomized trial, and it does not
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  prove the drugs cause hair loss equally in every group. Also today, a large cohort study
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  observational and not randomized, Link tears epitide to a lower short-term risk of endometrial
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  cancer.
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  In male mice, an animal study, and not a human result, Semaglutide showed an early bone
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  building signal.
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  Medical Republic reports that the peptide-related death has spurred a call for a telehealth inquiry.
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  This week's spotlight is compounding, shortages and copies, and a 2025 search of compounding
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  websites found 33 semaglutide or terzepatide products whose strength, root, or added ingredients
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  differed from FDA-approved versions.
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  That map is a product survey in the annals of pharmacotherapy, not a trial of patients.
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  Compounding means a pharmacy prepares a medicine instead of dispensing the manufacturer's approved
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  product.
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  Shortage rules had been the practical opening for semaglutide and terzepatide copies.
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  Semaglutide is a glucagon-like peptide-1 receptor agonist, a peptide that acts as
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  that receptor. A narrative review in the American Journal of Managed Care states it is FDA-approved
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  as ozemic for type 2 diabetes, and as wagovi for overweight or obesity. Demand, social media
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  attention, shortages and costs then drew both legal and illegal compounded versions. Once the
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  innovator shortage was resolved, the analyst paper says pharmacies could legally sell only unique
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  products, a different route, a different dosing approach, or extra ingredients, not a simple copy.
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  The survey ran from February 3rd to March 20th, 2025.
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  Two-thirds of the 33 products contained semiglutide and one-third contained tersepotide.
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  Forty-eight percent combined one of those drugs with some mix of cyanocabolamine, glycine,
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  niacinamide, docusate, or on dancetron.
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  Of 17 single ingredient products, 82 percent were sublingual and 18 percent were oral
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  disintegrating tablets.
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  Only 18% reported a beyond-use date, and 28% reported preferred storage conditions.
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  The authors found little justification for adding nutrients or docusate sodium to combination
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  subcutaneous products. They saw a rationale for on-dancetron, but not evidence that giving
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  it under the skin works for this purpose. They also saw a rationale for sublingual or
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  disintegrating tablets without a finding that those forms beat innovator oral tablets.
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  Their conclusion is that safety and efficacy of these compounded products are largely unknown.
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  A laboratory analysis, not a human study, tested compounded tersepatide mixed with vitamin B12 analogs from US sources.
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  Expert opinion on drug safety reports a widespread, previously unidentified impurity formed when tersepatide reacts with certain B12 analogs, present at substantial levels.
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  Those combinations had been mass-marketed as comparable to FDA-approved
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  terseptide without evaluation of potency or impurity profiles and sold as
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  personalized treatments. Clinical effects of that impurity are unknown. The
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  chemistry shows a quality defect, not what the defect does in a person. Human
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  evidence in these papers is thinner than the marketing. A retrospective study in
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  diabetes, obesity, and metabolism followed 94 people, 81 women and 13 men,
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  mean age 46.57 years at a commercial wellness studio. They received once
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  weekly compounded semagglutide with cyanokobolamine between June 2023 and
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  January 2024. After three months average weight loss was 4.11 kilograms or 4.57
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  percent. Fat mass fell by 2.67 kilograms and trunk fat by 1.10 kilograms. Lean
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  mass fell by 1.43 kilograms and skeletal muscle mass by 0.88 kilograms.
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  As a share of total weight, fat mass decreased while the proportions of lean mass and skeletal
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  muscle increased.
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  That study is observational and uncontrolled, not a randomized comparison with FDA-approved
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  semagglutide, and it cannot show the compounded product matches the approved drug.
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  Harms appear in a case series in the Journal of the American Pharmacist Association.
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  3 adverse event reports reached a regional poison control center after incorrect administration
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  of semi-glutide obtained for weight loss from compounding pharmacies and an aesthetic spa.
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  2 patients self-administered 10-fold dosing errors.
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  All 3 had nausea, vomiting, and abdominal pain, with most symptoms lasting days.
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  One also had headache, anorexia, weakness, and fatigue.
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  One sought care and responded to an anti-emetic and intravenous fluids.
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  One received a vial and syringes with no pharmacist counseling.
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  One reported measuring in milliliters and units rather than milligrams.
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  The author's note that vials lack the safety features of pre-filled manufactured pens
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  and can allow large overdoses.
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  The American Journal of Managed Care Review, narrative rather than new patient data, adds
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  that marketed compounded semi-glutide may lack historical quality controls and that fraudulent
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  batches have appeared worldwide.
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  No paper here shows a compounded copy has the potency, impurity profile, or clinical effect
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  of ozempic, wagovii, or approved tirsepatide.
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  Advantage of those sublingual or disintegrating compounded tablets over approved oral tablets
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  are not determined.
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  The 94-person weight change is not proof of safety or equivalence, and three poison center
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  cases cannot estimate how often errors occur.
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  Ozempic and Wagovi remain the FDA-approved semiglutide products for the uses named above.
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  The compounded semiglutide and tear-zepetide products in these papers are not FDA-approved.
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  After the innovator shortage resolved, only unique products were described as legally
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  sellable by compounding pharmacies.
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  Unapproved combinations carry purity, contamination, dosing error, and fraud risks that approved
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  pens were built to limit.
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  One thing worth knowing is that a coroner's finding, not a trial, treated prescribed CJC-1295
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  and Ipa Morellen as unapproved drugs with uncertain benefit and incompletely known risk.
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  Company reports on redotrutide and on oral ASC-30 are early human signals and diabetes,
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  not settled comparative evidence.
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  People given compounded semiglutide outside a trial lost weight and also lost some lean
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  and muscle mass, an observational pattern rather than a randomized result for an approved
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  pen.
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  A three-patient case series shows vial and syringe compounded semaglutide can be measured
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  wrong, with days of nausea, vomiting, and pain, which is a harm signal and not a rate.
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  That's peptides weekly.
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  This show is education, not medical advice.
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  Talk to your own clinician before acting on anything you heard.
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  I'm Patrick in Vancouver.
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  See you next week.
• 11:48
  A rating on Apple Podcasts or Spotify takes 10 seconds, and it is how new listeners find
• 11:54
  this show.
• 11:55
  One more thing.
• 11:56
  If you like today's episode, our sister show AI Chips & Data Center's Daily is worth
• 12:01
  a spot in your feed.
• 12:02
  The daily on accelerators, memory, and the data centers being built to run them.
• 12:07
  It's one of the Narin Network's daily briefings, all free at NarinNetwork.com.
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  Following the long arcs, story trackers on NarinNetwork.com follow major programs across
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  episodes. Tesla, SpaceX, AI, Space Science, and more. This episode used AI voice synthesis
• 12:24
  of my voice. Editorial selection and analysis are my own.