You will never see any tweets on Whately’s twitter account that challenge him. Many other journos do, even Jon Ralph occasionally!
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He will do nothing.
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Ah…the good old days when the game, clubs, players and media weren’t owned by the AFL
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Needs to be a concerned parent to get any traction.
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The question to ask is not, Is PPSNa on the banned list. The question that should be asked is have the performance enhancing properties of PPSNa been assessed by the WADA Prohibited List Expert Group (of which Harcourt is a member). Careful examination of the research projects funded by WADA into prohibited substances since 2012 does not contain any research on PPSNa.
Also of interest is that a literature search of PPSNa indicates that apart from the main mode of action being wound healing and use as a recovery drug it is described as an agent that stimulates the synthesis of new tissue and the extracellular matrix which makes up the bulk of cartilage material. It also stimulates the synthesis of fibroblasts, critical in the wound healing process. Finally PPSNa restricts the damage to existing tissue by hindering enzymes that destroy damaged tissue.
Bit of basic biochemistry - synthesis/stimulate/regeneration, fibroblast activity = anabolic processes???
TB4 = wound healing, synthesis of new tissue, recovery aid = anabolic process???
Remember section 2.5 of the WADA Banned List words like regeneration, synthesis, Fibroblast growth factors ETC.
And TB4 is a naturally occurring endogenous peptide hormone so safety is not an issue. PPSNa is a drug and an unregistered one at that. Need I say any more.
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And, the latest WADA call for research is primarily about detection, no focus on review of performance enhancing properties or health.
On detection, if WADA can come up with a technique in the future that separates endogenous and exogenous generation of TB4, what if the Essendon samples were retested? Until then no-one could be comfortably satisfied that the players used TB4.
As to safety, TB4 is manufactured in the body, as I understand it, PPS is not.
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Fixed.
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I was talking to my doctor about this stuff the other day, where can I get more info to give him?
I would suggest not doing the work for him. He has access to literature searches that you don’t. He also has direct access to the TGA Medical Regulation Division. As a GP he could apply under the SAS to release the drug for you. But this would not be easy given the amount of specific medical information and data he would need to provide. But it can be done. We know that at least 50 odd AFL players have availed themselves of the same opportunity.
That’s why I would suggest that most GPs wouldn’t get involved in the SAS process as it would involve a substantial commitment from them in an area of medicine most would not have a great deal of knowledge. They would more than likely refer your case onto a doctor that specialises in musculo-skeletal medicine or anorthopedic surgeon.
Didn’t Walker say that it took over 4 months to gain TGA approval? Each application is assessed on its individual merits. The other key element of Walker’s case was that the Carlton doctor was a specialist and had/has an interest in Paradigm.
It could be viewed as unethical but certainly Paradigm approached players, who had exhibited early stage OA, experiencing knee and joint soreness and pain after games, as part of a longer term marketing strategy for PPSNa. There are probably 8 million people in Australia who are desperate for the efficacy and safety of this drug to be proven and the success of the clinic trial is vital to that success. The TGA would not give approval under SAS if they were not convinced that the benefits far outweighed the side effects. But the fact remains that the drug is not registered.
However, the clinical trial demographic, does not include elite athletes playing a high stress game involving heavy physical contact. PPSNa possesses anti-coagulant properties and therefore there is potential for bleeding at the site of the wound as mentioned by Peter Larkins.
The AFL have stated that in 2015 Andrew Dillon had put together a policy and set of rules and protocols for all AFL clubs and players so that a there could never be a repeat of the Essendon fiasco. Here we have Dillon, McLachlan, and Harcourt not talking to each other and not singing from the same hymn book on a key issue that has everything to do with the AFL actually being active in protecting the health of its biggest asset - the players. But not only doing it but providing the perception that they are doing the right thing . No, they can’t even do that. And the media are obediently silent.
Harcourt needs to provide a clear scientific argument why PPSNa is not performance enhancing. I have always stated that if injections of exogenous TB4 could be proven clinically to repair and/or synthesise new tissue to replace the damaged tissue then I would accept that TB4 was performance enabling NOT performance enhancing. That evidence has never been produced.
I
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Thanks for the clarification. There are certainly ethical issues in regard to the promotion of PPS as a wonder drug , potential conflict of interests and the marketing focus on AFL players. I have not seen any reporting on its use in sports other than Australian rules.
There might also be some grievance on the part of physiotherapists - including sports physiotherapists - in regard to their contributions to mobility for those suffering from osteoarthritis.
Do you know of other countries providing for TGA type SAS approvals for PPS?
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Thanks for that thoughtful and informative summary.
I have one quibble: you say:
'the AFL actually being active in protecting the health of its biggest asset - the players.’
The players should be the AFL’s biggest assets but the AFL doesn’t’t treat them that way. Players are expendable in the AFL’s eyes. The way they have designed the tiers below the AFL competition gives them a constant stream of ‘cattle’ and thus the individual doesn’t count. Any player can be and is replaced.
The AFL’s biggest asset is the spectacle they sell to the media and sponsors. That’s because the more money they rake in the more the likes of McLachlan can cream off and the more power accrues to those running the show
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So your saying rich guys have stolen our game and and using it to futher enrich themselves. Ok agreed
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Maybe we should get advice from Lukin she’s knows all about this stuff.
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Who can you coach to ask Whatley questions?
Agreed. Most people would think the AFL are pro-active about all the players health. They are not but they know how to make it look as though they are because; “the look and the brand” are all important for the money making machine. The cattle are not.
It is also the breeding ground for a “groomed culture” for new staff at AFL House, they need to have a way of seeing and being and that is a specific qualification.
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Very true. Bit like the military. There are always plenty more "cannon fodder’ or in the AFL’s case, players.
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From what I have read Paradigm have a patent on the drug for use on patients who have been identified with bone bruising, a strong predictor of the onset of OA. My brief scan of relevant literature indicates that there are no other SAS like status for PPSNa for OA. In the U.S. and Europe a drug such as PPSNa would be granted what they call “orphan drug” status if no other treatment was available.
I may have already mentioned this but the cost to have a drug registered can take years from inception through to registration with costs running into the tens of millions of dollars. Clinical trials are not cheap. But the upside is that the potential gain financially is enormous.
There are many presentations and severities of OA and it is quite reasonable that a physios could successfully treat certain patients without the need for drugs that have side effects.
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From my understanding paradigm is an EDM festival.
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Go Bob!
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