Those knives should have been snakes.
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Taken from a comment posted on J34 fb page
Credit: @bomber5au
Given the below article, some interesting observations:
The drug is not registered by the TGA or the FDA
The drug is performance enabling or a “recovery agent” so from first glance, if the claims about TB4 are true, should be banned. In simply terms it stimulates the synthesis of the molecular matrix which forms cartilage at the ends of the long bones and strengthens it. Cartilage is like a damper for the joints that absorb the physical stress of movement. In WADA speak any mention of the words synthesis or stimulation indicate performance enhancement
No comment about WADA compliance. On the ASADA site it states that Pentosan Polysulfate is not banned.
It appears that Clinical trials have not been completed and reviewed by regulators and therefore the drug is not registered on the ARTG.
The drug has been given what is known as “orphan status”, i.e. there is evidence that it does what it claims to do and the TGA has approved the release of the drug on a restricted basis. That means that the club doctor can apply for a limited supply of the drug under prescription to a specific patient (one patient only for each application/prescription).
If, as is suggested, Harcourt has approved the use of the drug under what looks like a TUE (WADAs Therapeutic Use Exemption) and club doctors take advantage of this then it is possible that multiple players from one club could receive the drug under their own exemption status. Could this be defined as a team based injections program.
The drug is claimed to be a pain killer that allows players to train and play “normally”. Given that the clinical trial currently still running specifically targets osteoarthritis patients then what are the safety issues associated with the using the drug for “other joint,tendon and muscle pain relief”
Same question that always arises when talking about the use of pain killers and the further damage inflicted on the athlete and his/her life after sport.
Now the cat is out of the bag every club will not want to be missing out so the TGA can expect mulitple TUE’s from all 18 clubs. One would suggest that the AFL supports the use of an unapproved drug for its players and, if the AFLPA had any guts, the players would raise a big red flag right there. The TGA should recognise the TUE protocol is being abused and withdraw the status of the drug until the clinical trial is completed, reviewed and the drug registered.
Paradigm Biopharmaceuticals would be jumping over the moon at the free publicity and great marketing by the AFL. Expect your ordinary person in the street, who suffers acute pain from osteoarthritis, and cannot access this drug from his local GP because the protocol for gaining access to the drug is beyond most GPs, to be outraged.
Injectible painkillers should be banned in the AFL and all sports for that matter.
The AFL does not value the health and well-being of the players who, at the end of the day, are the very reason the AFL exists.
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I’m admin on fb site now. Thanks to bomber5au for the comments.
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Andrew Walker saying his use of the substance was approved - that AFL are confusing things. (Gee, where have I heard that before?) Only read the byline, can’t get past the HS paywall.
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Wow. He says he has a letter from Harcourt saying was ok!
I’ll post article shortly
The AFL are utter hypocrites & liars not that we didn’t already know that. JT can add this example to his case as the AFL came out this week and lied already on what Harcourt had said.
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Retired Carlton star Andrew Walker says approval was given for miracle drugSAM EDMUND, MICHAEL WARNER, Herald Sun
9 minutes ago
Subscriber onlyRETIRED Carlton star Andrew Walker has hit out at the AFL for clouding the status of a breakthrough pain drug being used by up to 50 AFL players.
Walker was the first player to receive injections of pentosan polysulfate sodium, which he says cured a chronic knee condition that cruelled his 202-game career.
But the former Blues champ told the Herald Sun he was angered by an AFL statement on Wednesday night which declared the league had not approved its use.
Walker, 31, said he had a letter from AFL chief medical officer Dr Peter Harcourt giving it the tick.
“I’m pretty frustrated — it’s really unfair on the players,” Walker said.
“We are expected to go to through the process, we do that, and yet we still have to talk to you guys (about the legitimacy of the treatment).”
Asked about the letter from Harcourt, Walker said: “I’m not in a position where I can forward on any of that stuff - that’s a privacy issue.“But speak to him mate. Has anyone actually spoken to Peter Harcourt? He is the one who needs to talk.”
The drug company behind pentosan polysulfate sodium on Thursday revealed it had notified the Australian Stock Exchange in late 2015 that the AFL had “cleared” the drugs use by players.
Paradigm Biopharmaceuticals told the ASX: “Before the patient was treated, clearance was also sought from the Australian Football League as the patient is a current AFL player.
“The AFL cleared the use of Zilosul (pentosan polysulfate sodium) in treating the patient.
“During the treatment, involving a total of six intramuscular injections … there were no adverse events and the product was well tolerated"
Dr Harcourt has not returned Herald Sun calls, but in the statement on Wednesday night, the AFL said “Dr Peter Harcourt did not approve this medication”.
“It is a misrepresentation of the role and the views of the AFL medical director to say he approved this medication.”
The AFL Prohibited Treatments List bans “any experimental treatment or treatment as part of a research project, unless approved by the AFL”.
An AFL spokesperson declined to state its position on the ongoing use of pentosan polysulfate sodium by players.
Paradigm chief executive Paul Rennie called on AFL boss Gillon McLachlan to “make it absolutely clear that the appropriate steps were taken” before players were injected.
“We have copies of all of the emails that have gone back and forward between us and the AFL, including Peter Harcourt,” Rennie told SEN.
“I’ve asked to speak to Gill McLachlan, I can’t speak to him.
“He’s up there in the ivory tower and can only be contacted through an email.
“I think the AFL has created an absolute storm because of semantics. Clearly, our company adheres to every and all of the highest possible standards in clinical process. We just don’t go and say: ‘Here - use this drug’.”
Paradigm BioPharmaceuticals chief Paul Rennie says the “appropriate steps were taken”.
Rennie added: “In 2015 an AFL club doctor and myself approached Dr Peter Harcourt … and we informed him that the doctor wanted to treat this particular patient with this drug.
“Peter Harcourt reviewed the drug and said it that it did not appear on any ASADA or WADA banned substances (lists) and therefore it is cleared for use by elite athletes.
“Peter Harcourt was well aware that this drug was going to be used on an AFL player.
“At no stage was there any opposition given by Dr Harcourt, although he’s now saying in his statement that he didn’t give express authority.
“We can say categorically that Dr Harcourt was aware a club doctor wanted to use the drug.”
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Fixed
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Peter Harcourt reviewed the drug and said it that it did not appear on any ASADA or WADA banned substances (lists) and therefore it is cleared for use by elite athletes.
OK then.
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Makes you wonder if what was rumoured at the time was true in that Hamilton took our program to the AFL and we were given the all clear also.
Nice cushy job he has at the AFL now also & Robson too allowed a free pass on to next role.
They know what really happened
IMO AFL was and still is happy for supplement programs to be pushing limits if it keeps players on the park and able to run faster and further so long as no one else knows about it.
Made an example of EFC because they had to.
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Understand Harcourt is on the Gold Coast as Commonwealth Games OIC for TUE exemptions. Probably also making sure that no-one gets cancer what with all his expertise in that medical field.
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Was having a look around and saw that, according to his linkedin profile, Branson was with Collingwood 2006-2010 but since 2016 has been Sydney’s match day doctor in Melbourne.
Had been Melbourne Storm’s chief medical officer Dec 2011 - 2014 too.
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Bigallan, it is an interesting observation about the section of the banned list under “Banned Methods” I would suggest section M1.3 could be applied to pentosan polysulphate as it is a mild anti-coagulant and therefore complexes a key blood component to interfere with the clotting cascade. It changes the blood chemistry.
Your mention of the education of the athletes is worth expanding. Informed consent is a critical part of the SAS protocol. The practitioner has a duty of care to not only explain to the athlete about the benefits of the drug but also the side effects and dangers of using the drug. PPS is designed for use in patients with a specific medical complaint (bladder inflammation and associated pain). However, the danger in athletes using the drug, especially in collision sports like AFL, is that a knock may cause uncontrolled bleeding in the joints or even worse. It might sound dramatic but medicine and drug development is based on good, rigorous science and proper risk management.
Using PPS in athletes to treat joint soreness or bone bruising is not a proven mode of action. Hence the need for clinical trials to be completed and the results reviewed by the Regulators (TGA).
It is pretty simple really. Pentosan Polysulphate is not approved for use by the TGA for the treatment of arthritic or pre-arthritic joints. The AFL should not be subjecting their biggest asset to what could be called an experiment.
Harcourt has form for not being professional or thorough. Every chance that all club doctors have SAS applications in at the TGA to include PPS in their medikit. - player by player. Such an act undermines the essence of what the SAS was set up for.
The TGA and the AFL need to be put on notice because this just doesn’t fly with the supporters of any sport.
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According to the sportsmedbiologic site and current Collingwood staff list, Branson is currently contracted club doctor at Collingwood.
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“Take bits out”
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If Gil and Harcourt are unavailable, what about Andrew Dillon? I thought he was in charge of such issues, including prohibited forms of treatment ( at least he signs off on such matters).
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According to an article of 16 September 2017 in the Riverine Herald quoting Walker, there was a 4-5 month process to get TGA and WADA approval ( as he was playing with Echuca).
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Good find BA
Walker is captain/coach of that side this year no doubt on good coin and back enjoying life again. If an ASADA ban came after he’d been told by the AFL it’s ok would not go down well.
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Go fark yourself with a rusty flagpole Peter Harcourt.
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I’m lost for words. This must be devestating for rhe essendon 34. The mongrels that hung them out to dry are doing the same thing themselves.
You’d love to think there will be consequences but we know it won’t happen
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is this gear any good? that’s all i care about, my ankles are farked.
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