Interesting development with the advertising and distribution of drugs/peptides imported into Australia. The Therapeutic Goods Administration (TGA) has issued a claim in the Federal Court against PeptideClinics P/L claiming that they are falsely advertising the benefits of using these medications. In other words they are making false claims of efficacy. Peptide Clinics operate a website that allows access to the information, only if potential customers complete a questionnaire, that they claim is sufficient for a “doctor on staff” who on assessment of the responses to the questionnaire, is able to diagnose the medical condition and then prepare a scrip that will allow legal access to the substances. Sounds very dodgy doesn’t it.
The court documents contains this statement:-
The Website also contains information published by the Respondent that asserts a number of purported benefits of Peptides and Peptide Treatments sold by the Respondent including anti−ageing, body building, body fat and weight loss, injury repair, tanning, heart health, mood regulation (including reducing anxiety and depression), libido/sexual function enhancement, preventing sleeplessness, bone health and optimising health and fitness goals.
And yes, TB4 is specifically mentioned.
A win for the TGA could be at odds with WADA and ASADA as claims of efficacy (performance enhancement) could be scuttled by the TGA.
Call me cynical but it is worth remembering that the TGA and ASADA both come under the Health Portfolio and that bastion of integrity Greg Hunt. Reckon there might be a bit of behind the scenes manoeuvring go on with this. AGAIN.
Peptide Clinics have already stated that they will/have taken down the advertisements.
The TGA have also added TB4 to their Schedules List with statements that TB4 is not registered anywhere in the world, that there is limited research regarding the harm and possible therapeutic benefits of the substance and that it is potentially carcinogenic.
Any drug, peptide. procedure, device that is not registered by any Medicines Regulatory Agency in the world, is, by definition, an unproven substance.
Yes, but they were just scare-mongering without any evidence or support from a government agency.
They could have done even more government endorsed scaremongering if the TGA had said this earlier.
And where do they get their info from that it is “possibly carcinogenic”. There are ZERO references in the medical research literature to any studies of its mutagenicity let alone carcinogenicity.
Did they get their info from all those Wilson beat-ups in the Age?
so if their claims about peptides are false or found to be by the TGA then how can 34 players who didn’t test positive to them in the first place be found guilty of what?? optics??? there needs to be a very large enquiry into this !!
Well, that’s not exactly correct. For example, humans produce acetaldehyde in metabolism of ethanol, which even without drinking, is naturally produced by digestive bacteria (in low levels).
Acetaldyhyde is highly carcinogenic, but with natural production alone (ie: without excessive drinking or other environmental exposures), the level is so low that there is no risk.
The TGA state that the substance is “potentially” carcinogenic so let’s not get too hung up that. WADA may very well claim that TB4 is potentially performance enhancing because athletes take the substance because the marketing hype makes all those efficacy claims. BUT TB4 is not registered so therefore efficacy and safety are unproven. TB4 was added to the banned list on perception or even “a guess”
The suggestion of carcinogenicity would most likely be mentioned because, as others have said, TB4 occurs naturally in the body but in very low concentrations (which is normal for most peptide hormones). Because the product potentially comes from dubious manufacturers in equally problematic facilities there is no real quality control over purity, testing, validated processes, stability and dosage regimes. Overdosing in this scenario can be dangerous to the patient.
The TGA’s case against Peptide Clinics covers a wide range of peptides, some of which are registered but are being marketed as a treatment for other medical conditions (requires extended usage registration). My fear is that the scope of the case for non-compliant marketing of these substances will overlook the specifics of each of the peptides. I would hope that each substance and each claimed efficacy was judged in its merits. But like the 34 Essendon players they will be tried as a job lot.
It is difficult to penetrate the website and look at the claims made about TB4 other than the claim mentioned in the Court File that TB4 is used to treat cardiac patients. One hopes that all the claims made about TB4 are scrutinised. If they are then the TGA would be at odds with their fellow Health Department colleagues at ASADA.
Oh please no, not ASADA…
An example of ASADA in action is below.
FOI Request
Dear (name redacted)
Congratulations. You have won first prize. You will hold the record forever. No one can ever trump the contempt you have shown towards me over my FOI request.
You have redacted every single word on all eight documents and then given me a truck load of legislation to justify the redactions.
How am I supposed to determine whether you have applied the legislation correctly?
I hope you are not suggesting that I should trust you or anyone else at ASADA. It’s hard to image there has ever been a more corrupt organisation than ASADA and it is impossible to believe any government agency ever contained more liars.
For your edification, the OAIC and I were told twice by two separate ASADA liars that there was no such document as the CEO Recommendations.
Then, to my surprise, someone in ASADA came clean and admitted that there was such a document. But that person then lied and said it would be in contempt of court or parliament to release it.
When I proved ASADA had actually released the document to another organisation, ASADA dropped the contempt of court lie and released the 97-page (about 90 pages were redacted) to me. Unbelievably and unconscionably, 30 per cent of the contents page was redacted.
Hopefully, unsurprisingly to you, given the foregoing, I won’t be requesting anyone at ASADA review your shameful decision. I shall make a request to the Information Commissioner this morning to review your unjustifiable decision.
They are a law onto themselves and some want to give them even more power/s.
I wish Bruce all the luck in the world re the Information Commissioner and hope there will come a time when someone with some brains/insight can put a stop to this Star Chamber organisation ASADA is.
