Sorry Saga - “It’s actually quite funny people thinking they know more than they actually do”


#7361

The TGA are the gatekeepers of all medicines, drugs, medical devices that are manufactured in Australia or imported for use in Australia. They work under a very strict Code and set of Regulations and Protocols. And so they should.

Up until 2016 TB4 had no status on the TGA databases. It was not registered or listed on the Australian Register of Therapeutic Goods (ARTG), it was not listed on any TGA Schedule which includes all poisons , substances not registered, experimental substances, dangerous goods.

Without going into the complexity of all this can I just repeat myself again that TB4 is not a registered substance anywhere in the world and has therefore not be subjected to a strenuous review by independent scientific and medical experts from Regulators like the TGA (Aust, the FDA (U.S.) and MHRA (UK). Evidence would include clinical trials in Humans. This has not been done

ASADA and the TGA both come under the control of the Health Department (Greg Hunt).

In 2015 an application for the Scheduling of TB4 was submitted by an unnamed applicant citing the reason that TB4 was on the WADA Banned List because it was performance enhancing and for this reason TB4 should Scheduled. The application can be found on the TGA website.

The TGA were clearly concerned about the manner in which TB4 was being advertised, sold and accessed without legitimate purpose (see later). I absolutely support this rationale.

If you read further down the web page the TGA list the reasons why they want to include TB4 on the Schedules List which include limited research data on efficacy, not registered anywhere in the world, experimental substance, concerns on safety etc. Then it claims that the substance is used as a performance and image enhancing agent which, to my mind, is contradictory to the other reasons.

The application contains no visible supporting scientific/medical references for this performance enhancing claim.

In relation to the legitimate concerns of the TGA about the advertising and sale of TB4 it is worth noting that the TGA (Dept of Health) has lodged a claim before the NSW Supreme Court to have an Australian Company (Peptide Clinics) withdraw all products and claims made on their webpage claiming unsubstantiated efficacy about their products. One of these substances is TB4.

I have heard that these claims have been removed but I can’t confirm them as access to the webpage is restricted. I also understand that the case is still before the court because of other illegal practices (issuing of prescriptions).

The TGA have been questioned about the contradiction and although they have acknowledged that the reasons for Scheduling could be viewed as contradictory they say that their statement does not imply performance enhancement. My response was that as the gatekeepers of medicines for Australia their decisions, which become part of the regulatory framework, should not be open to interpretation or question. I have been invited to submit an application to review the Scheduling of TB4 (a bureaucratic nightmare).


#7362

Just to make it quite clear I am not supporting the view that the Players were given TB4. My view has always been that it is more likely some were given thymomodulin.

I also believe the applicant was ASADA (McDevitt).


#7363

If you submit your application, might it then be possible for you to get access to others for instance the one you mention which you think could have been submitted by McDevitt?


#7364

The Application involves following a strict protocol and does not have much flexibility in the way it must be presented. The application involves presenting an argument to challenge the decision made by the TGA which is based on what was presented as evidence by the applicant in support of it being performance enhancing.

I am challenging the ambiguity in their reasons for Scheduling TB4, I am not challenging TB4 being Scheduled, if that makes sense.

Before I prepare this document I need to find out the full content of the application, which includes the medical and scientific evidence that TB4 is performance enhancing. I know there is none and so do the TGA I believe.

But, as I mentioned in the post, the TGA have many reasons why they want to Schedule TB4, but the performance enhancement claim made by the applicant cannot be supported without validated efficacy data. I am after the full application (from ASADA I believe) to prove that no such supportive data was provided. The only information given was that TB4 was on the WADA Banned List in 2015. Which is not true because it was not identifiable on the WADA Banned List as a stand alone substance until January 2018.

We know that nobody can challenge the validity of the WADA Banned List. We also know that only 5 of the 23 sub-classes of substances on the WADA Banned List have any medical or scientific evidence of performance enhancement effect. WADA has not carried out, either through their own Laboratories or subcontract to external research facilities, a brief to study the PE effects of TB4. The Cologne lab was asked to prepare a test method for detection of TB4 but could not establish a baseline or differentiate between exogenous and endogenous TB4. Yet the CAS was able to introduce data about elevated levels of TB4 in some Essendon players.

The TGA have admitted to me in an email that their statement on the reasons for Scheduling TB4 being that TB4 is used for performance and image enhancing benefits does imply efficacy. I want that clearly articulated in the Scheduling document. If that is achieved then the rationale for Scheduling is consistent. And by logical argument challenges the validity of TB4 being on the Banned List.

The devil is in the detail.


#7365

You will recall that, at Senate Estimates, the ASADA lawyer intervened to state that TB4 was classified under both SO and S2 in the WADA Code.
That line was also run by Handelsman at the AFL Tribunal, although Handelsman conceded that his view that TB4 was not registered for use in any country was an opinion rather than an evidence backed fact.
Seems to me that ASADA/WADA were having an each way bet in case there was no evidence of performance enhancement. SO would pick up the potential health aspect - one of the two criteria legally deemed necessary for inclusion on the WADA banned list.
Of course ASADA did not provide any response to the Senators questions as to health and performance enhancing effects of TB4, despite having taken the questions on notice - flagrant disregard of the obligations of public servants. Mc D May have left but the lawyer may still be there.


#7366

But didn’t ASADA already know that there were other players from AFL clubs who had higher TB4 levels in their test than most Essendon players tested?

These were from the last lot of tests done that the players and the EFC supposedly knew nothing about. How did ASADA explain that? And; did the AFL know was the information shared?


#7367

Just to note that inclusion on the WADA banned list requires two of three criteria - health, performance enhancement, against the spirit of sport.
I can appreciate that the unregulated use of TB4 without medical supervision could raise health concerns. That in itself could be sufficient reason for the TGA to schedule TB4.
But is it practice for the TGA to take into account the performance enhancing effects of a substance?
The TGA was involved in the ACC investigation of potential criminal links to the use of PIEDs. As TB4 was widely promoted on bodybuilding sites, I presume that is why it was included in the ACC inquiry. That might be the extent of TGA knowledge - ‘implied efficacy”.
As to the TGA applicant, I would not rule out a Handelsman role, given that he holds down a position in WADA and has represented Australia at scientific meetings of the UNESCO treaty.
As a Professor of endocrinology he has carved out a niche in the sports world ( including for the IAAF). For all I know his scientific expertise may qualify him in the area of perfomance enhancement in sport, but he has a conflict of interest and cannot be regarded as an independent expert. . His objectivity was even found wanting by CAS in the E34 case.


#7368

What about Dr. Harcourt who works for the AFL. He talked about the Essendon players and named them before they appealed the CAS decision.


#7369

And where is he now? Still with AFAIL and/or does he have side gigs?


#7370

It is an interesting observation that here we have the organisation that is responsible for anti-doping in Australia with their CEO (McDevitt) and Chief Legal Counsel (Perdikogiannis) both informing the Senate Estimates Committee that TB4 is classified under SO and S2. And then we have Handelsman, a highly regarded Medical Scientist, and a person who sits on the Advisory Panel that determines whether substances should be placed on the WADA Banned List, agreeing with them.

That says a lot about the knowledge, integrity, honesty etc of these people when it clearly states in the WADA Code that a substance cannot be in 2 categories. It is astounding that these people, who pursued the Essendon players for 2 years, did not know this.

Handelsman’s “expert” evidence was found to be lacking in substance at the players hearing but he still remains on the WADA payroll.


#7371

The TGA would have been called into the ACC investigation to provide advice on the entry of these substances into the country. There are thousands of drugs that are imported into the country either under prescription or for over the counter sales. The TGA have a database that identifies each importer/distributor, how the substance is transported, stored, labelled and packaged, how much is imported. They would probably advise the Border Protection, Federal Police, etc on the legitimacy of the shipment.

Also the TGA would be concerned and provide advise to the relevant authorities on the advertising, sales and distribution of substances where claims of efficacy and safety are not supported by clinical data. The other issue of concern is the Facility, Country of Origin, Method of Manufacture, and Quality Assurance System under which the substance is made (Big Concern).

The safety issue will always be a concern for an unregistered, experimental substance. However, during my research into TB4 I have not found any real evidence that indicates it is unsafe. Afterall, TB4 occurs naturally in the body. The TB4 used in research studies is manufactured in TGA (or FDA) accredited facilities such as Mimotopes, founded here in Melbourne and now a global company supplying custom made peptides worldwide.

The concern from TGA’s point of view is when the substance is made in countries where there are few, if any regulations, and the quality and consistency of manufacture is not guaranteed. Another TGA concern would be the uncontrolled use of the substance by the end-user, either dosage or administration (especially if the substance is delivered by injection).

The TGA would not specifically be interested in performance enhancement which is a rather nebulous term medically, but is a perfect fit for the WADA Banned List. If the claim was that TB4 facilitated lean muscle growth (anabolic), or stopped inflammation, or made your hair grow then they are specific clinical outcomes.

The question everybody, even your run of the mill sports fan, should be asking is how is performance enhancement measured. With all the other performance elements in the output of athlete how does one single out the impact of a drug on that output. For anabolic steroids it is well established. For most of the other substances on the banned list it is based on perception. If an athlete believes that by taking a substance they are better able to perform then it must be performance enhancing. That is the WADA way.

The TGA, in my view, should be clear and unambiguous in their rulings. The Schedule states use for performance and image enhancing purposes but also that it is unregistered anywhere in the world (and by definition has no proof of efficacy and safety). They might say to me in an email that their statement does not imply efficacy but I say that this caveat should be included in their document.

In could be anyone or any organisation that has submitted the Scheduling application but my money would be on ASADA.


#7372

Anyone know if there is any in depth documentary in production about the saga?

I kind of expected one by now, but im not sure if the saga is completely over??
I have not really been keeping up in depth about it… is there anymore outstanding legal cases surrounding that have to be completed?
Maybe trying to get interviews for it with those involved and negotiating them… imagine someone got Dank… 60mins would pay him 100grand for interview for sure…


#7373

Last time I checked, Harcourt was Chair of a WADA sub committee on sport specific doping issues


#7374

How interesting about the two categories. And still they haven’t recognised their error.

Interesting too that Harcourt is still on the WADA pay roll. Just like the AFL, WADA it seems, also looks after its loyal employees.


#7375

The WADA classification of TB4 is covered in paragraphs 224-231 of the AFL Tribunal report, mostly based on Handelsman’s opinion . In para 224, Handelsman cautions against the S2 classification because of the absence of studies on the benefits of TB4 to humans (as compared to animals). He favours S0.
Much later and well after the TGA decision, WADA lists TB4 under the current equivalent of S2. Why? Has there been subsequent scientific evidence to persuade H to change his mind?
So, leaving aside the technical legalities, there appears to have been no evidence at the time that the players took any performance enhancing drug in the event that they may possibly have taken TB4.


#7376

Up until 31st December 2017 TB4 could not be found on the WADA Banned list as a stand alone entity. Up until that time it was allegedly covered under a catch-all definition in Section 2.4 “”"… and other growth factors" So in 2012 and even later in 2016 when McDevitt lied to the Senate Estimates Committee TB4 would not provide a response if entered into the ASADA website search engine. So even if all the 34 players looked TB4 up on the ASADA website in 2012 they would not have found it.

McDevitt lied to representatives of the Australian Parliament.

A Paper published in Sports Medicine (2018) by Heuberger and Cohen found that only 5 of the 23 classes of substances on the WADA Banned List showed any positive performance enhancing effect. TB4 was not one of the substances.

One significant observation from the authors was the rather scant amount of clinical data that was available on many of the substances (performance enhancing wise).

And both Handelsman and Harcourt sit on the WADA Advisory Panel that advises on additions (or omissions from the Banned List). Given Harcourt’s unprofessional and inaccurate accusations at the November 2013 Zurich Sports Science Seminar about the Essendon players and Handelsman’s unconvincing testimony at the AFLADT and the CAS hearing it must be very comforting for our athletes to know that they well supported by medical scientists of such knowledge and integrity.


#7377

I found this article from The Age (Jon Pierik), July 2014

"In his speech, Harcourt feared “35-odd” players could eventually suffer from ‘‘hormonal issues or cancers’’ as a result of the injecting program run by sacked sports scientist Stephen Dank.

It emerged on Thursday that Harcourt had said this without any specific knowledge of what side-effects may or may not be felt by the players.

On their show-cause notices issued by ASADA, the players are alleged to have taken the banned peptide Thymosin beta-4.

Little said it was “regrettable” that Harcourt “chose to engage in irresponsible speculation about the health of our players at an international conference, without talking to the club and its players”.

“Independent medical experts have provided information and feedback on the supplements issued to players, and given the club a high level of comfort regarding the short and long term health of our players,” he said.

“Dr Harcourt also suggests our players ‘passively’ accepted the use of supplements. This statement is offensive - our players took considerable steps in this regard.”

Little said players had insisted on consent forms. The players had insisted that club doctor Bruce Reid approve all supplements and that all supplements be WADA approved.

“In 2012 and 2013, we conducted comprehensive medical evaluations of our players and we continue to provide ongoing monitoring,” he said.

AFL Players Association acting chief Ian Prendergast also defended the players against Harcourt’s claims and criticised him for speculating on the players’ health.

“We also believe Dr Harcourt’s comments with regards to potential health consequences are unhelpful and have the potential to create unnecessary stress and anxiety for players and their families,” Prendergast said."


#7378

My blood boils yet again from reading about this charlatan’s despicable actions. (I read this article the first time around).


#7379

Yes AT. And neither Harcourt or Handelsman were held accountable for their mistakes. Both continue to feed at the OIC trough.


#7380

before they had even been given show cause notices too if I remember correctly …had the against the rules interim report even been issued at that stage???