Much ado about nothing: the peptide they say never worked
There is much confusion about the significance of the banned peptide at the centre of the AFL doping scandal - and perhaps that is not so surprising. The company behind AOD-9604 knew back in 2007, after six clinical trials of 925 patients, that the drug had completely failed to treat obesity. But after burning through some $50 million developing the drug, Metabolic Pharmaceuticals Pty Ltd, which owns the patent, has continued to spruik its so-called body-enhancing benefits.
Its published study focuses on the safety data - and not the efficacy data - which basically showed that those on the drug were lucky to lose one kilogram after 24 weeks.
Instead, it has relied on the rumour mill among bodybuilders in the gym and a flourishing black market in the sale of illegal peptides to help the survival of its expensive patent.
The Melbourne-based company, which does not manufacture the drug, claims it is a potential treatment for cartilage and muscle damage and even osteoarthritis, though there is absolutely no clinical evidence of that.
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.
The scandal around AFL club Essendon erupted in February this year when it reported itself to the Australian Sports Anti-Doping Authority over its 2012 supplements program.
This was a day after the Australian Crime Commission released a report confirming the widespread use of illegal drugs, including peptides, in Australian sport and links to criminals, prompting the former head of ASADA, Richard Ings, to call it the "blackest day" in sport.
But what has followed is several confusing months of counter-allegations among football officials, ASADA, the ACC and sports scientists over the drug's legal status.
The Essendon club's former sports scientist, Stephen Dank, has said he only ever injected players with vitamins that were within WADA guidelines, but he has admitted using AOD-9604 on players and claims he was advised last year by ASADA that this was legal.
ASADA denies this. It is now investigating at least five external doctors allegedly used to obtain prescriptions for peptides - among allegations of "doctor shopping" - for Essendon players to determine whether they actually physically examined them.
Essendon doctors Bruce Reid and Brendan De Morton are understood not to have prescribed any drugs used in the Essendon supplement program.
Australian registered doctors can legally prescribe AOD-9604 with prescriptions made up by a compounding pharmacy, says the TGA.
However, it cannot be legally imported without a special permit under the strict Special Access Scheme, which requires a doctor to apply to the TGA for permission to treat a particular patient with the drug, including describing the specific clinical need. "There have been no applications under the SAS for AOD-9604," the TGA spokeswoman confirmed on Thursday.
However, companies such as the Brisbane-based Peptides Direct sell it online with a doctor's prescription, although the company did not return Fairfax Media's calls.
The drug's lack of efficacy on weight loss may raise questions of what the fuss is all about, but there is just one obvious problem: the clinical trials tested a fat-burning pill and allegedly at much lower doses than that given to the footballers.
It was not tested as an injectable because that would be commercially unpalatable.
In short, nobody really knows what capability it has as an injectable, let alone at what dose. And, at any rate, this should only be determined under a properly supervised clinical trial.
Meanwhile, the Adelaide University medical researcher who led the six clinical trials from 2001 to 2007 has expressed his regret that the "negative data" was not published soon after the trial was completed.
Professor Gary Wittert, Adelaide University chair of medicine, told Fairfax Media this week: "I wish we had pushed the issue much harder at the time. There would be far less debate now. It highlights the importance of publishing negative data."
Further, biotechnology company Phosphagenics, which used the drug in an anti-cellulite cream BodyShaper, sold in major stores, revealed this week that it dumped the ingredient last November after 17 months because it was useless and incredibly expensive.
"It wasn't really having an effect, but also the cost was a factor because there were other ingredients in the formulation that from a fat-reduction perspective were more effective," says Phosphagenics' chief scientific officer, Paul Gavin.
"It really is a cost issue for us. All peptides are very, very expensive ... The product performs pretty much the same way without the addition of AOD-9604 because of the other ingredients in there."
This week, documents discovered at Essendon headquarters allegedly show that Metabolic Pharmaceuticals Pty Ltd had been reassuring sports doctors that the peptide would enhance performance, aid in soft tissue recovery and was very popular with bodybuilders.
Metabolic's parent company, Calzada Ltd, has had to deny it was involved in a secret drug trial involving four Essendon players and claims the case notes, from Dank, were to support a patent application and not for any use in a clinical trial.
Despite its announcement to the stock exchange in 2007 that trials showed at 24 weeks participants lost one kilogram at best, only last month Metabolic told its patent holders that it was going ahead with attempting to license the product in the US for use in sports drinks and dietary supplements. It is also pursuing commercial opportunities in the veterinary industry. This is after its chief, David Kenley, admitted several months ago that there is no proof it had any body-enhancing effects in humans.
In a statement to Fairfax Media on Thursday, Calzada Ltd said: "The US generally recognised as safe 'GRAS' status is being explored as another viable commercial path for the company to pursue to potentially derive early revenue. Whilst AOD-9604 was not successful in human trials aimed at obesity, the Company believes there is sufficient efficacy data to enable a potential food, drink or dietary supplement product to be successfully marketed in the US."
ASADA investigators are expected to hand down their report in the next fortnight.