Carlton 2015 Clinical Trial

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http://www.canberratimes.com.au/afl...treatment-20150629-gi08mc.html?skin=text-only

Carlton doctor to help test experimental knee treatment
Date: June 29 2015

Jon Pierik
Carlton Football Club doctor Phil Bloom is involved in what is an experimental — but potentially revolutionary — treatment to ease the short and long-term impact of bone bruising on AFL players.
Bloom will help Melbourne biotech company Paradigm Pharmaceuticals in a clinical trial to test pentosan polysulfate sodium, a drug that has been used to ease clotting and migraines but could now help with leg injuries through a series of injections. The company hopes to test the drug on AFL players – which could raise eyebrows at league headquarters.
"It will be a matter of recruiting both general public and AFL players which is conditional on the AFL allowing us to use it," Bloom said.
"They (players) will then be entered into before-and-after MRI scans and pain surveys and disability surveys to determine if it's helping."
Bloom said the company had not yet approached the AFL's chief medical officer, Dr Peter Harcourt.
"The normal process is, you need to put in a written application to use a medication that is under a trial — that's their (AFL) new rules — and then present all the evidence to the AFL, and they will say whether they are happy to do that," he said.
The AFL has tightened its medical protocols in wake of the Essendon supplements saga, where the players involved still cannot prove exactly what peptides they were given.
Paradigm Pharmaceuticals will need to provide extensive details for the AFL to allow any players to be tested, or for the drug to eventually be used as accepted treatment.

Paradigm Pharmaceuticals chief executive Paul Rennie, a former SANFL player, had trialled the drug on himself and said he was now pain-free. He said the subcutaneous injection process would involve twice weekly injections over three weeks.
Rennie said Melbourne Storm chief medical officer Ruben Branson would also help with the trials.

"There are a number of AFL doctors that do want to participate in the clinical trial. As I said, we'll be looking at players with bone bruising as detected by MRI, then they will be treated," he said.
"I hope it's going to be the start ... for the footballers' sake that if they get these injuries, and concussion is another one, they are just starting to see ... they are having problems later in life. Hopefully these produce better outcomes for athletes later in life."
This material is subject to copyright and any unauthorised use, copying or mirroring is prohibited.
[ Canberra Times | Text-only index]
http://paradigmbiopharma.com/
Graeme Kaufmann is ex-CSL. CSL is a major sponsor of Essendon FC.
http://paradigmbiopharma.com/about_us/company-directors-management/
Graeme Kaufman, Non-Executive Chairman
Graeme Kaufman BSc, MBA, has wide ranging experience across the biotechnology sector, spanning scientific, commercial and financial areas. His experience with CSL Limited, Australia’s largest biopharmaceutical company included responsibility for all of their manufacturing facilities, and the operation of an independent business division operating in the high technology medical device market. As CSL’s General Manager Finance, Mr Kaufman had global responsibility for finance, strategy development, human resources and information technology. Mr Kaufman has also served as an executive director of ASX-listed Circadian Technologies and a non-executive director of Amrad Corporation, and held the role of Executive Vice President Corporate Finance with Mesoblast Limited until 2013. He is currently Chairman of Bionomics Limited and IDT Australia Limited, and non-executive director of Cellmid Limited.
Paul Rennie, Managing Director
Paul Rennie BSc, MBM, Grad Dip Commercial Law, MSTC, has sales, marketing, business development, operational and IP commercialisation experience in the biopharmaceutical sector. Paul’s experience includes working for Boehringer Mannheim (now Roche Diagnostics), Merck KGGA as national sales and marketing manager and Soltec (FH Faulding Ltd) as their director of business development. Paul also led the commercialisation of Recaldent® a novel biopharmaceutical arising from research at the dental school, University of Melbourne. Paul took an R&D project from the laboratory bench to a commercial product now marketed globally as an additive to oral care products. More recently Paul worked in a number of positions with Mesoblast Ltd. Paul was the inaugural COO and moved into Executive Vice President New Product Development for the adult stem cell company. For the past 18 months Paul has worked full time at Paradigm BioPharmaceuticals Ltd.
http://www.medifydaily.com.au/parparadigm-pharmaceuticals-raising-10-13-5m-through-issue-of-35c-shares-to-develop-pentosan-polysulphate-sodium-in-bone-marrow-edema/
http://berlinpharmaceutical.com/2013/en_news_db.php?id_news=4
 

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omg deflection
 

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It is a drug approved for use by WADA and ASADA (note, it took about 30 seconds to check.)

What's the problem?
View attachment 148241
The problem is, it is experimental. They are using it for purposes other than which efficacy has been tested. FFS have we learned nothing?
 
The problem is, it is experimental. They are using it for purposes other than which efficacy has been tested. FFS have we learned nothing?
While it is experimental for the specific purpose it's now being looked at, it has completed testing for it's current use, and been approved for human therapeutic use. It also hasn't yet been used on footballers, and there is a process in place prior to it's use that way.
 
The problem is, it is experimental. They are using it for purposes other than which efficacy has been tested. FFS have we learned nothing?

It looks like everything is on front street though! So yes, we have learned, if players were to participate, they'd know:

A) what they were receiving
B) that it is not banned

It's experimental and being used in a way that hasn't been tested...this would be the test and given they've announced to the world their intention, you'd think it likely the trial will follow relevant protocols!

This doesn't sound like murky Mexico injections
 
While it is experimental for the specific purpose it's now being looked at, it has completed testing for it's current use, and been approved for human therapeutic use. It also hasn't yet been used on footballers, and there is a process in place prior to it's use that way.
And look, yes I appreciate that, but in my opinion, we should not be experimenting on players, full stop.
 
The problem is, it is experimental. They are using it for purposes other than which efficacy has been tested. FFS have we learned nothing?

If it is safe and in the rules doesn't it makes sense to test it on elite athletes? Assuming that the methodology is all honky dory and the players are happy with it.

What we've learned from this saga is:

1. If you're going to run a program like Essendon did there needs to be proper checks and balances on the purchase of supplements.

2. That all injections are administered by the doc.

3. If the doctor, head coach and senior assistant have issues to speak with the players rather than argue among themselves about it.

4. If an employee is given an order to not inject anyone and he does, sack him on the spot.

5. Don't let the AFL stick its head in an investigation.

6. If an investigation like this is running then get an injunction so rampant speculation doesn't get accepted as fact. Then we'd get serious accounts of it after the fact, like Chip's.

7. Don't let the boss of ASADA run around the country publicly pushing for a deal without the trial being heard.
 
The problem is, it is experimental.

Experimental being a poorly monitored ad hoc black ops injectathon with goodness knows what exactly, conducted a bloke like Dank who isn't able to produce records of what was injected and when; versus experimental being a controlled clinical trial being undertaken by medical doctors with AFL knowledge and approval for a specified substance already approved for human use and approved by WADA as not being performance enhancing - might as well be using a different word lest you're trying to illicit an emotive reaction.
 
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