Ariel Bogle and Donna Lu 

The online wellness clinics letting customers ‘add to cart’ experimental peptides without a doctor consult

The growing market for injectable peptides includes many schedule 4 drugs that are not yet approved for use in Australia but can be prescribed by a doctor
  
  

Different medical ampules toned blue on black background.
On one website, customers could browse peptides including MOTS-c, which is not approved in Australia, after completing a health questionnaire and selecting areas of interest such as ‘mood and sleep’. Photograph: Aivolie/Getty Images

Online wellness clinics are allowing customers to browse and select for purchase experimental injectable peptides before any doctor consultation has taken place, Guardian Australia has found.

Approved peptide drugs play a key role in medicine – insulin and Ozempic are some of the best known – but there is now a growing online market for experimental peptides, which proponents claim can help with everything from muscle repair to slowing the ageing process.

Many have not been approved for use by the Therapeutic Goods Administration, which classifies several as schedule 4 drugs, with the added control of being illegal to possess “without authority” such as a prescription.

There are a number of online wellness clinics in Australia that offer prescription services for these medications.

The clinics are not breaking the law by supplying peptides with a doctor’s prescription. But the Australian Health Practitioner Regulation Agency (Ahpra) has expressed concern that health practitioners offering customers “access to a predetermined medicine” might not be meeting the standards of good medical practice.

Peptides, the building blocks of proteins, occur naturally but can also be synthetically made. 

Some are natural human hormones with varied functions in the body, such as insulin, which regulates blood sugar; oxytocin, often referred to as the “love hormone” for its role in social bonding; and endorphins, which are natural painkillers. 

Peptide drugs have played a key role in medicine since the 1920s, when insulin was first discovered and used. Globally, dozens of peptide drugs have been approved for clinical use, including 40 in the last decade. They are used in various areas, including in oncology, for pain management and as metabolic drugs. There are hundreds of peptides being tested in clinical and preclinical studies.   

Among the best-known peptides are a class known as glucagon-like peptide 1 (GLP-1) receptor agonists, which include semaglutide, more commonly known by its brand name Ozempic, and tirzepatide (marketed as Mounjaro). These drugs mimic the natural peptide GLP-1, which is produced in the gut and brain when we eat. 

There is a growing online market for experimental peptides, for many of which there is limited evidence of safety and efficacy in humans. 

Many of these peptides have not been approved for use by the Therapeutic Goods Administration, which classifies them as schedule 4 drugs, with the added control of being illegal to possess “without authority” such as a prescription. 

This category includes AOD‑9604, which is marketed as a fat-burning drug, but which has not been found in human clinical trials to result in weight loss; BPC-157, which has been investigated for wound healing in animals but for which there is little evidence in humans; and thymosin β4, which was implicated in the Essendon and Cronulla supplements scandals.

Guardian Australia made profiles on three websites that promote services aimed at longevity and wellbeing.

All allowed us to immediately browse and “add to cart” injectable peptides that have not been approved by the TGA after completing a health questionnaire and identifying an area of interest, such as anti-ageing – and before speaking with a medical practitioner. This included price and information about potential benefits.

Guardian Australia did not proceed to the next stage of consultation and prescription. There is no suggestion any of the clinics are providing medication to customers without the necessary prescriptions.

One site, Phyx, displayed peptides including MOTS-c and BPC-157 after the onboarding process, with information about their supposed health effects.

These peptides are not currently approved in Australia, and there is limited evidence for their efficacy in humans.

Sign up: AU Breaking News email

In an email sent after sign-up, Phyx said customers could “explore our range of medications”.

“Following your selection and purchase, we’ll arrange a consultation with one of our doctors for the prescribing of your chosen medication,” it went on. “This step ensures that the medication is suitable for you.”

Dr Jack Janetzki, a lecturer in pharmacy and pharmacology at the University of South Australia, said it was “concerning” and against best practice that patients were able to select medicines without first having a medical consultation.

“I would very much advocate for a consultation being the first port of call rather than self-selection of a medicine,” he said.

Janetzki points out that for an unapproved peptide not evaluated by the TGA, greater professional responsibility falls on doctors and compounding pharmacists to determine the medicine’s safety and efficacy.

In response to questions from Guardian Australia, a Phyx spokesperson said its setup was “not a ‘shopping’ process” for prescription medicines, and did not constitute advertising to the public.

“Many individuals who visit our platform have previously accessed peptides through unregulated or black-market sources and may not understand what is clinically appropriate or legally accessible. Allowing them to indicate their ‘interest’ in a therapy gives our medical team context, not approval,” she said.

“Patients are not granted medication because they clicked on a product page; they are granted medication only when a doctor, operating under their own independent clinical judgement, decides it is safe, lawful, and appropriate.”

A spokesperson for Ahpra said clinicians “should only prescribe where clinically necessary, after a thorough assessment, and always put the welfare of the patient first”.

The regulator said it remained “concerned that some practitioners working in health services designed to provide customers with access to a predetermined medicine may be failing to meet the standards of good practice”.

The Phyx spokesperson said the clinic “does not offer predetermined, automatic, or pre-selected medication pathways. Our clinicians undertake detailed assessments and prescribe only when clinically necessary.”

On another site, Ageing Solutions, customers could browse MOTS-c and an “anti-ageing” bundle that included pre-filled syringes of NAD+, or nicotinamide adenine dinucleotide, after completing a health questionnaire and selecting areas of interest, such as “mood and sleep”. On RegenMed, you could similarly browse and “add to cart” NAD+, Epitalon and BPC-157 after completing a health questionnaire.

Ageing Solutions’ FAQ page states that a doctor reviews the “Pre-Medical Screening questionnaire” before granting access to the range of “Integrative Medical Solutions” – for Guardian Australia, this occurred instantly and the doctor’s identity was not disclosed.

“Simply add your choice of products to cart and proceed to checkout,” it goes on. “All orders for Schedule 4 Medications (including peptides) must be reviewed by our medical team and scripted by our Doctor before it is sent to our partnered pharmacy.”

Epitalon is not currently included in the Australian Register of Therapeutic Goods (ARTG), and in Australia, NAD+ is not included in the ARTG as an injectable.

A director and shareholder in the companies operating both Ageing Solutions and RegenMed said in a text message that he was not able to answer questions at this time, but that Guardian Australia needed to complete the process with pathology and consultations to “understand the hoops you need to go through to purchase not only S4 products but also our supplements”.

He said the businesses were closing for Christmas, and that “our processes are changing again where there will be no products including supplement programs seen before pathology and a Dr consultation”.

The advertisement of prescription-only medicine is banned in Australia.

In 2019, a company named Peptide Clinics Australia was fined $10m for advertising schedule 4 substances, including by displaying them for purchase on a part of its website that was accessible to customers after they had completed a health questionnaire.

The TGA told Guardian Australia it could not comment on individual matters, but said the decision to use any medicine should be made jointly by the prescribing medical practitioner and the patient.

“Materials that promote a health service (including telehealth) as a means to obtain a specific prescription-only medicine are likely to amount to advertising of prescription-only medicines and may be in breach of the Act,” the TGA said in a statement.

The Phyx spokesperson said the company “does not advertise prescription-only medicines, nor do we promote access to specific treatments through our website or marketing. Any educational material provided is designed to support patient understanding, not direct them toward a therapy”.

 

Leave a Comment

Required fields are marked *

*

*