Jez & Dodga's AOD Playpen

New thread title had me worried for a second 

love the thread title

 

and that's me done with it.

I would've gone with AOD Dungeon

Even the AFL-accredited media don't mention AOD any more and yet people here do.

 

Let that sink in for a second.

 

To be fair, it started with JBomber having a go at BomberJez. He was only replying to the jibe. Check the first post in the thread.

 

Then someone said to me that it was ok to inject because it was in a cream in Myers and its in food in the USA. Just needed to remind them that isn't what got us off the hook.

 

Approved for human use is what happens in stage 0-1 of the clinical trial process. It cannot proceed to human trials without actually being approved for human use - AOD is & was at stage 3 & therefore is & was absolutely approved for human use & was already beeing sold comercially in Aust & particularly the USA where it had GRAS approval & was sold in foods. Its basic stuff thats been explained here for 2 years. Everyone who's not a ignorant troll knows this. I stand by my claim that you are either a troll who ignores reality OR you are unable to comprehend truth.
Your comments in the Winders thread was that he was leaving because of the supplements saga. Since he's now staying continuing to stand by your comments highlights the weakness of your character.


1. GRAS approval conditionally came in June 2012. We were injecting it BEFORE it was even allowed as a 1mg insertion in food in the U.S...which is completely irrelevant anyway.
2. It did not receive full GRAS approval until 2014.
3. The WADA code states you can compound it. True. It also states that it does not have TGA approval then it is banned. Which way do you want it?
4. AOD is not approved for human use. I quote.. 'The drug has not been granted approval by Australia's Therapeutic Goods Administration, or any other health authority in the world, for human use and is therefore banned by the World Anti-Doping Agency'
5. The fact players like Winders and Ryder consider leaving is an absolute tragedy.
6. Drugs aren't often approved before clinical trials are completed.

 

 

Not approved by the TGA does not equal not approved for human use.  There are literally thousands of substances legally sold in Australia that have not gone through the 10+ year extremely expensive process to get TGA approval.  You have to provide conclusive proof of a therapeutic benefit & for example the alternative & Eastern medicine field does not see this as viable.   It can't be put any more plainly to you.  If you want to believe media spin over reality then again I believe you are a troll.  BTW drugs are always approved for human use as part of the clinical trial process.  You can't progress to human trials without it.  Why is that so hard for you to comprehend?

 

BTW the WADA code does not state that every substance without TGA approval is banned.  It doesn't work like that.  Part of the code refers to substances without TGA approval but there are also parts of the code that state that a substance has to also meet the criteria for a Ped.  The code like just about every law, regulation or  guideline is open to ambiguity & therefore interpretation.  Dank claims he sought & was given approval by ASADA & they are the ONLY statutory authority in Australia who can make that call.  Again this has all been explained before & all the non-trolls understand it. 

Well done mods!!!

Should’ve done the same with the debate that killed the previous ASADA thread.

Jez,

 

You need to read very carefully what you have stated in your point 3 above. The TGA have at this stage not approve the manufacture of the AOD 9604 molecule. However they have approved the compounding of AOD9604 by a suitably qualified person, i.e. they can add other non therapeutics such as salts, stabilisers, and other compounding substances (this process is well characterised in the pharma industry).

 

Point 4 you talk about AOD9604 being a drug. Now you need to understand the definition of a drug. Drugs are chemical entities, often referred to as APIs (active pharmaceutical ingredients) that either on their own or compounded have been proven in the treatment, cure, prevention or diagnosis of a medical condition/disease or otherwise used to enhance physical or mental well-being.

 

At this stage the jury is still out on the physiological benefits of AOD9604. Dank, as a qualified Biochemist, would have found some studies that convinced him of the benefits but he would have many others who would not share his optimism. Trials have shown negligible side effects which is good news. At this stage AOD9604 probably fits in the sports supplements cupboard.

 

Also on Point 4 you might want to consider that the reason the TGA has banned the production of AOD9604 is that firstly the facility in which it might be manufactured must have a TGA license. The facility must meet many very strict regulations (just read some of the cGMPs for pharmaceuticals and maybe then you will realise this is not a simple process). And it could cost upwards of $100,000 just in regulatory costs alone, let alone setting up a manufacturing process. Secondly AOD9604 is not a commercially viable product. The cost of such an exercise would be prohibitive. Hence why the TGA has allowed limited manufacture of a powder/pill by a licensed compounding chemist. Also consider that if the drug or supplement is an injectable then it must be manufactured in a validated cleanroom or even sterile facility. Now your talking upwards of a $10mill for a very small, compliant facility.

 

Finally on your point 6. I don't know if you have ever worked in the pharmaceutical industry at a technical/scientific or regulatory level but I can assure you that majority of drugs, and I mean drugs, have not been subjected to a clinical trial. Many drugs because of their chemical structure are grouped together and slight structural modifications to an existing drug to provide differentiation from a rival company's product can be piggy-backed on clinical trials of similar drugs. Maybe a small scale animal study to provide assurance of safety might be all that is required. A good example is Viagra - manufactured by Pfizer for people with a particular heart condition and turned out to have another beneficial outcome underwent full clinical trials in human subjects but other similar products are now available (because Pfizers patent expired) that did not require the same registration process.

 

Clinical trials involving studies in human subjects is reserved for the new and novel drugs that are seen to provide break-through treatments of serious diseases, such as diabetes, cancer, Alzeimers etc. The big pharmaceutical companies can afford to pay the $50mill to $100 because they know that have a huge commercial market to get a quick return on their investment. Regulators like the TGA in Australia and the FDA in the U.S. work very closely with companies in ensuring that these drugs can be made available as soon as possible whilst ensuring they are safe and effective but providing assistance in managing the cost of producing these products using risk based strategies.

 

The TGA and WADA are mutually exclusive. WADA may choose to take advice from the TGA but given they were setup to look after the Olympic sports one has to question their integrity and by association ASADA's as well. The TGA are the sole arbitrators in Australia of the status of drugs, supplements, medical devices whether they be prescription or OTC.

 

Perhaps this whole AOD9604 saga could have been avoided if somebody went to the TGA website and looked at the status of AOD9604. Certainly ASADA didn't know about it and either did WADA because they both fluffed around with it whilst Jobe was being booed every time he went near the ball in that game in the West.

 

This entire saga has been polluted and corrupted by people who profess to be experts because they read what is written in newspapers and what they see and hear in the media. Unfortunately the media have no idea what they are talking about when it comes to scientific and medical terminology. And unfortunately the people who listen to, read and watch this rubbish believe it to be true. Just ask Lindy Chamberlain and the Y2K bug.

You clearly understand the complexities of it more than me.

 

There's a lot of info above which will probably take a few days to get my head around and address.

 

Can someone link me to the compounding pharmacy provision in the code that we used? I'm having trouble finding it my guess is that ASADA/WADA buried it.

 

Something must have gone wrong with the flux capacitor if AOD is still being discussed.

 The current head of ASADA said that AOD was never being investigated. Why on earth are people even discussing it?

 

How funny is it that ASADA are yet to nail down their star witness Shane Charters. They are beyond incompetent.

 

Didn't she also say there was insufficient evidence to charge the players for TB4 usage!

I can't recall

New thread title had me worried for a second


The title alone makes it worth a visit.

Gonna enjoy swinging the ban hammer once they don't mention AOD in any charge forms.

Is this the new asada thread?

Jez,

 

You need to read very carefully what you have stated in your point 3 above. The TGA have at this stage not approve the manufacture of the AOD 9604 molecule. However they have approved the compounding of AOD9604 by a suitably qualified person, i.e. they can add other non therapeutics such as salts, stabilisers, and other compounding substances (this process is well characterised in the pharma industry).

 

Awesome post bomber5au. I've just taken a snippet as this is an important point.

 

BTW, I'm keen to move on from this too but seeing others raised it. If we move on, we should move on with the correct understanding.

 

Can we get your honest view of the S0 clause as it relates to AOD.

 

S0 -Any pharmacological substance which is not addressed by any of the subsequent sections of the Prohibited List and with no current approval by any governmental regulatory health authority for human therapeutic use (eg drugs under pre-clinical or clinical development or discontinued, designer drugs, substances approved only for veterinary use) is prohibited.

 

To me it seemed that maybe Dank played on the term "use"  in the above definition. 

 

One of the reasons I imagine WADA were angry and made a stance was that if something wasn't approved for manufacture that they assumed sports scientists would stop there and not look to administer substances that had been approved for compounding. Whilst that does pass the English definition of use. The counter is that they go further to give clarification on what they mean by specifically giving the example that  drugs under pre-clinical or clinical development or discontinued ....(are) prohibited.

 

Could you clarify that compounding is done pursuant to a doctors prescription. 

 

I will apolgise for getting involved in the AOD discussion but I felt the need to respond on the posts by others because they thought compounding element meant we passed S0. 

 

It is my understanding that is incorrect because AOD fails the drugs under pre-clinical or clinical development or discontinued element.

 

The Garnham article and explanation was that we got off because of the "not addressed by any of the subsequent sections of the Prohibited List"  part of the S0 definition. ie. due to ASADA giving out advice that it wasn't in breach of S2, it meant that it had been considered by subsequent sections of the Prohibited List

 

Its crap to have to bring it up but I think its important that we understand the history accurately.

How come there are more interesting and better researched posts on this thread compared to the other one?

Nice reply, dodga.

 

My whole issue with AOD is that we simply should have not been taking it.

 

It's not TGA approved for human use and that's pretty black and white in s0.

 

I'm sure Reid wasn't the only one aware of how taking such a substance looks. We can see Dank's workaround with the compounding pharmacy but even that just makes our decision making look even worse.

 

I'm hoping the email Dank sent where he asks WADA if its banned and they say "not under s2 but see ASADA regarding s0" isn't the only check we did. You can see Danks reply as a clear deliberate misinterpretation of the rule and I would go as far as saying a deliberate attempt to cheat.

 

While the AOD issue is over from an infraction perspective it will never be over from a PR/historical view.

FFS can we at least say it's not approved for THERAPEUTIC use. It's a pretty ■■■■■■■ massive distinction.

I can’t believe you morons are still even talking about AOD…and it’s no use replying to me. I’m not reading this thread. Just accidentally clicked on it.

some of you should watch dallas buyers club and see a dialogue that many drugs/peptides etc are not approved purely because of politics and the power of drug companies..

Every team in the AFL would have been pushing the boundaries on the use of supplements/peptides etc. A number of coaches have already admitted they were experimenting with peptides. In fact the AFL's own investigation revealed that 11 other clubs were heavily involved in supplement experimentation. Dank is no dill. He has set up a very lucrative wellness and anti aging business where I'm sure many well to do people are paying plenty in an attempt ward off old age. Working in the pharma business Dank would be acutely aware of the TGA and what substances are on the ARTG (Australian Register of Therapeutic Goods). The TGA are the threat to his business not ASADA or WADA. I have no doubt he knew exactly the status of AOD9604 with the TGA and knew he could have small batches of a compound containing AOD9604 and not be in breach of TGA regulations.

 

WADA are not that particular. I am confident that WADA made an all encompassing decision to ban AOD9604 outright, no matter in what form it was presented. ASADA took the "courageous" decision to follow WADA and when challenged by Dank on the exemption for compounded material got confused and flustered and threw their hands up in the air. Then we had conflicting statements by different representatives at ASADA and WADA. In the meantime Jobe was being booed.

 

Bomberjez, you say that AOD9604 is banned by the TGA and that's pretty much black and white in S0. That statement better represents the WADA view not the TGA because, as already stated it can be compounded and it may be ordered through a doctors prescription (I hope that answers your question Dodga)

 

For a substance that is not an issue for us you seem to be creating a huge problem in your own mind about appearances, thought processes and motivation of individuals that is just pure speculation on your behalf and/or maybe influenced by what is being dished up by the media.

 

Of course you are entitled to your opinion but really let it go. Save your energies for next season.

 

Dodga, I'm no expert on the WADA code and how it is interpreted. The document is rather vague at best and from what I have read seems to have been written with a degree of arrogance. There is a reason why most sports in the US have told WADA and USADA to ■■■■ off and I have no doubt that the AFL will go it alone once our saga concludes.

 

You mention "drugs under pre-clinical and clinical development". In my opinion this refers to novel or new drugs that are still being characterised and efficacy and safety issues defined. AOD9604 is well known as being a small peptide that mimics a small section of hGH molecule (about 10% of the molecular weight). Researchers thought that this section (the AOD9604) would aid in weight loss without the anabolic impact of the hGH. They got it wrong as indicated by the clinical trials in which the AOD9604 was administered as a food supplement.

 

The world of science and medicine with its ethics, regulations, procedures, systems and many, many fields of endeavour are captured in documents, papers, journals, pharmacopeia, books etc. that would fill the MCG many times over. I have spent 45 years and 2 post graduate degrees in trying to understand less than 1% of it and these journos reckon they know it all from reading some info on the internet.

 

I share your interest in understanding what happened but do you really think we will ever know the full truth. Sure we did the wrong thing and we have been punished with the most comprehensive list of sanctions ever in the history of AFL/VFL footy and one of our greatest ever players bullied and slandered for nearly 18 months. It is a disgrace.

But Bomberjiz and Lord Darth Dodga want more punishment for all those at the Club. Even though AOD is off the ■■■■■ list, these two intellectual still want to whip up a frenzy over it.

And on the other thread the big question is TB4 orTB500, doesn’t anyone write in English anymore !!