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Sorry, but Australia is going to have to be Geoblocked 7 years 9 months ago #16837

Hazel wrote: Precisely Paul. There is no discretion and there is good public reasons for that. The law can't envisage all the situations it will be applied to. We know ourselves what an unusual situation this is, what an unusually good doctor James is, and what an unusual health peer support and advice forum this is. That the TGA regs captures that is unfortunate, not incompetent or sinister. Complainants are a different matter.
The reason they have strict liability is to avoid any wrangling and to create a situation that is clear to everyone in it- no defence. Sounds terrible, but think in terms of workplace safety: too bad if the boss wasn't there, if they told their worker not to do something- if something happens, it is still the bosses fault because something has happened so they must not have done enough. No argument, no buck passing.
In other scenarios it is what we mostly want the law to achieve. No High Court Judge can get off drink driving any more by saying they were called to an emergency, because it is strict liability - alcohol in breath, driving- there is no more to the story no matter who you are.
In fact, the TGA are exercising the only discretion they have, which is to give a warning/time period for compliance.


I wholeheartedly disagree. Every case should be judged on its own merits. Governments are great at 'one size fits all' , but any engineer knows the fallacy in that way of thinking. In the US they now want to remove urinals in the mens room out of fear of 'discrimination' Puhleeese.....

"....that the TGA regs captures that is unfortunate, not incompetent........" So, knowing it's wrong, but doing it anyways is 'the best way'? Unacceptable in my book.
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Genotype 3
VL 4,100,000
ALT 101 AST 71
Treatment Naive
Started Sof/Dac Jan 12, 2016
VL= <15 4 weeks in. AST/ALT normal.
VL=UNDETECTED 8 weeks in.
SVR4= Virus back. 3,300,000

Started generic Epclusa Sep. 23, 2017

4 weeks in <15 *Detected.
12 weeks in <15 *Not Detected.
16 weeks in <15 *Not Detected.
Finished 24 weeks treatment 3-17-18
SVR5 <15 Not Detected.
SVR 20 <15 Not Detected.
SVR 44 <15 Not Detected.

Thank you Jesus.
Thank you Dr. James
The following user(s) said Thank You: beaches

Sorry, but Australia is going to have to be Geoblocked 7 years 9 months ago #16842

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It’s simply bureaucrats being ordered to flex their muscles by vested interest groups.

Bureaucrats are the same the world over. They can make things happen over night, or frustrate things until the cows come home ... hoping that attrition wears you out and you give up.

They all act the same way, no matter where in the world their desk is or what language they speak…

1983: Hospitalised with Acute non-A, non-B Hepatitis after ICU blood transfusion 3mths earlier => HCV GT2
22/02/16: (pre-tmt) ALT 61, VL 2.48 IU/ml Hepascore 0.32 (F1/2), fatigue, brain fog, bloating (Treatment Naïve)
10/04/16: (Start tmt) Sofovir +DaclaHep (SOF + DCV) by Hetero Labs in India
09/05/16: ALT 34, VL: NOT Detected :cheer: :) , FBG 11.9 :huh:
17/6/16 FBG 5.7; PPBG (@14.22) 6.9 (@ 20.45) 7.1; BP 124/72
:) (Accu-Chek Mobile & Omron Auto BP Monitor) :)
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Sorry, but Australia is going to have to be Geoblocked 7 years 9 months ago #16843

Exactly. It's actually the beginning of socialism. Same medical treatments, same car, same income, same opportunity, etc. After all, we're all the same. Hogwash. That promotes mediocrity, at best. The individual is the smallest minority. "Individuals, unite!!!" Wait......... ;)
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Genotype 3
VL 4,100,000
ALT 101 AST 71
Treatment Naive
Started Sof/Dac Jan 12, 2016
VL= <15 4 weeks in. AST/ALT normal.
VL=UNDETECTED 8 weeks in.
SVR4= Virus back. 3,300,000

Started generic Epclusa Sep. 23, 2017

4 weeks in <15 *Detected.
12 weeks in <15 *Not Detected.
16 weeks in <15 *Not Detected.
Finished 24 weeks treatment 3-17-18
SVR5 <15 Not Detected.
SVR 20 <15 Not Detected.
SVR 44 <15 Not Detected.

Thank you Jesus.
Thank you Dr. James
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Sorry, but Australia is going to have to be Geoblocked 7 years 9 months ago #16845

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I haven't been on line for a while, so just seen this.
It honestly makes me SO sad.

What's wrong with people in power?
Fixhepc has saved my boy, my only child, who I thought would get sicker & sicker.
He is a different child now, happy & full of life AND HEP FREE.


THANK you James, and thank you Fixhepc for always being there for me & my son.

I'm ashamed of my country, I used to be proud, but the high & mighty have taken our freedom away.
Sydney became a nanny state, now the whole of Australia seems to be.

Really sad to think what the future may be like.
Money seems to be the only thing that matters. :(

Cindi x
J the young dragon slayer is:
HepC 1a since birth
Male aged 15
VL 2000000
Started Twinvir/ 10-11-15-then Sof/led.
NO sides so far !
after one week VL : 37
after 4 wks VL : UND !
EOT 2/2/16 UND.!
4 wks. post tx results....pending....
7/3/16 VL result : 4 week post tx: SVR !
12 weeks SVR !
24 wks SVR yeeaa!!
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Sorry, but Australia is going to have to be Geoblocked 7 years 9 months ago #16848

CJ you just said it so well!

I haven't read here for awhile either and I've been sitting here reading and feeling just plain sad :(

Such a wealth of information on this site. It has been a highlight in my life to have seen such integrity, selflessness and the strive to help and save lives that I've seen here. All I can say is 'hear hear' to what everyone has posted, and thank you Dr Freeman for being a man of integrity, courage and for all you have given!
reg nurse and wife of:
genotype 3 (probably since '75), f4, cirrhosis, Tx naive
Oct '15 - Dx hcc
Pre Tx -- VL: 330,000......, AST 202, ALT 137, Bil 24, ALB 30
04/11/15 -Sof & Dac
30/11/15 -VL: 80................, AST 28, ALT 18, Bil 12, ALB 32
06/01/16.-VL: not detected, AST 29, ALT 16, Bil 13, ALB 34
01/02/16 -VL: not detected, AST 28, ALT 16, Bil 13, ALB 36


.
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Sorry, but Australia is going to have to be Geoblocked 7 years 9 months ago #16849

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Hi Tricia, I agree. James is a man of integrity &courage.
A very rare human being in this big greedy world.

Also thanks to all the lovely people on this forum.
Such a special place.

xo
J the young dragon slayer is:
HepC 1a since birth
Male aged 15
VL 2000000
Started Twinvir/ 10-11-15-then Sof/led.
NO sides so far !
after one week VL : 37
after 4 wks VL : UND !
EOT 2/2/16 UND.!
4 wks. post tx results....pending....
7/3/16 VL result : 4 week post tx: SVR !
12 weeks SVR !
24 wks SVR yeeaa!!
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Sorry, but Australia is going to have to be Geoblocked 7 years 9 months ago #16851

James-Freeman-Facebook wrote:

Redirecting to an overseas forum seems sensible and suggestions are welcome as to which one (or ones) we should suggest to Australian users so they can find mutual support somewhere in cyberspace.


I hesitate to suggest other sites in case in so doing I merely bring down on someone else's head the legal difficulties that Dr Freeman and FixHepC have encountered. And one of the unique attractions of this forum has been that Dr Freeman, through his numerous posts, has generously given us the benefit of his unrivalled expertise on matters to do with hepatitis c and its treatment.

But, nevertheless, in case anyone is unable to take advantage of the technical means to evade the post 15th June geoblocking (perhaps because, like me, they don't know how to) there are some potential alternatives which may be worth exploring.

There is mgalbrai's site which I assume is based in the US:

forums.delphiforums.com/generichcvtx/messages/1/fixhepc

and also Alsdad's site which I assume is based in the UK:

killthedragon.freeforums.net/

(I believe the original reason Alsdad set up this site was precisely for this contingency: to act as a potential refuge in case of FixHepC being closed down in whole or in part.)

However, fleeing to another site may only prove to be a stopgap unless the underlying legal problem can be addressed. Alsdad's site in particular could be vulnerable because the UK/EU regulations seem to be similar to the Australian ones.

If the FixHepC forum can be geoblocked in Australia because of alleged infringement of Australian medical advertising laws could we also see it, sometime in the future, being blocked in some or all of the EU countries? This would be not because the forum is based in those countries but because it would otherwise be accessible there infringing their own respective national/ EU drug advertising laws.

Greedfighter informs us that Harvoni is openly advertised on American TV. This prompted me to google the issue. It seems that amongst developed countries only the USA and, I think, New Zealand don't ban DTC (direct-to-consumer) advertising of prescription only medicines. So on the basis of worst possible case thinking could we end up in a situation that this forum, or forums like it, are blocked in every developed nation apart from the USA and New Zealand?
Male Geno 1a F3-4 Tx Naive
Contracted early 1970s Diagnosed 2012
Started 12 wks TWINVIR (Sof/Led) on 15 Nov 2015
Pre-treatment VL 1.8 million
UND at 8 Dec 2015; UND at 12 Jan 2016
Ended 12 wks TWINVIR on 6 Feb 2016
9 Feb 2016 EOT VL test <15 PCR Negative
UND at 3 May 2016 SVR12
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Sorry, but Australia is going to have to be Geoblocked 7 years 9 months ago #16852

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Hi Thurl,

It is more a case of FixHepC in Myanmar choosing to geoblock Australia (rather than the other way around) in order to allay the assertion from the Australian TGA that FixHepC is engaged in advertising in Australia.

That way, FixHepC can carry on its mission until the day that the Myanmar government also decides that it doesn't want to help cure the rest of the world of HCV.
Diagnosed Jan 2015: GT3, A0+F0/F1. Fatigue + Brain-Fog.
Started Sof+Dac from fixHepC 10-Nov-2015. NO sides.
Pre-Tx: AST 82, ALT 133, Viral Load 1 900 000.
Week4: AST 47, ALT 58. VL < 15 (unquantifiable).
Week12 (EOT): AST 30, ALT 26, VL UND
Week16 (EOT+4): AST 32, ALT 28, GGT 24, VL UND
Week28 (EOT+16): AST 26, ALT 22, GGT 24, VL UND
Ever grateful to Dr James.

Relapsed somewhere after all that... Bummer!

Jan 2018: VL 63 000 (still GT3).
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Sorry, but Australia is going to have to be Geoblocked 7 years 9 months ago #16854

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Hello Tricia and CJ,

Reading your posts made me think on the fact that greed is indeed a strong force against which one may not so easily oppose.
Looking into the past history however, greed was challenged / opposed by spiritual leaders. They do have a kind of additional power that the normal people may not exercise with full efficiency.

I would imagine a nice round table with living spiritual leaders, like Dalai Lama, Deepak Chopra, Pope Francis, Paulo Coehlo, Thich Nhat Hanh and why not Rhonda Byrne :) talking about Harvoni vs generic drugs from India. I wonder what would they sustain? The profit of pharmaceuticals companies or the lives of the 150 million patients with Hep C which cannot get the treatment because of the greed....

Too bad that reaching such spiritual leaders is in fact a kind of mission impossible, I doubt one can simply write them an e-mail.....

Cheers,
RHF
In fiecare an HCV ucide peste 500000 oameni.Medicamentele generice pentru hepatita C functioneaza. Nu deveni statistica! Cauta pe Google “medicamente generice pentru hepatita C”.
HCV kills more than 500000 people every year. HCV generic drugs work. Don't become a statistic.
By sharing this Youtube video you might save someone’s life!
My TX: HEPCVIR-L[generic Harvoni]-India
SVR52 achieved
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Sorry, but Australia is going to have to be Geoblocked 7 years 9 months ago #16855

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Hi Thurl,

Vororo is correct in that it will only be those with an Australian IP address who will be geoblocked, so mostly applicable to Aussies who would be the only ones seeing a redirection to an alternative forum that can provide them with support and answers to their questions. This has been brought about due to a combination of strict Australian prescription drug laws and Dr Freeman being an Australian resident doctor to whom those laws apply.

So someone like yourself in the UK (or any other country) won't be affected by this action and will still have full access to FixHepC without needing to either understand the technical means or google 'how to avoid geoblocking'.
G3a since '78 - Dx '12 - F4 (2xHCC)
24wk Tx - PEG/Riba/Dac 2013 relapsed
24wk Tx - Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx - 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 - 22/06/17 UND
SRV12 - 27/07/17 UND
SVR24 - 26/10/17 UND
:cheer: :cheer: :cheer:
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Sorry, but Australia is going to have to be Geoblocked 7 years 9 months ago #16862

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Gaj,
We can copy things from this forum and post them on our sites right? There's nothing that stops us from doing that. This forum is public.

Whatever happens, I want to thank all of you, for your acceptance and willingness to help others. You're an amazing bunch.

P
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Sorry, but Australia is going to have to be Geoblocked 7 years 9 months ago #16872

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I caught up with this morning and have been reading through all of your responses since the first post by Dr James. Through you all I have had a quick ride through all of the emotions: shock, anger, sadness, observations, more anger, acceptance? (not likely!), options, technical talk, ways forward. I used to be a bureaucrat in a past life so tried to work through the logical reasons for the TGAs decision but realised that I don't think so much like a bureaucrat anymore.

I have had a lot of firsts since reading that first article about generic HepC treatment in the SMH last year. My first consultation with a doctor using Skype (in Tassie no less!) the first time I have ordered medication from overseas, my first Hep C treatment, my first post on this forum when I shared my status with people other than close family and friends, the first time I realised what an exceptional forum this is, my first blood test in years that had a Hep C undetected result and the first time I realised how much better I feel.

The first time I realised that Dr James is not only an exceptional doctor but an exceptional human being. I'm still in awe of his bravery, compassion and capacity for what must be an enormous workload. Underpinning all of these posts is the absolute commitment to supporting and protecting Dr James and his team. It's not often you can say that someone literally gave you your life back.

I'm still reading through the reasons and legalities of the TGA decision and it may take me a while to work through the techo stuff but there are too many compassionate and driven people on this site for it not to continue.
G1a probably early 1980's, Biopsy F1(2010), F2-F3(2015). VL 5+mill; 2+mill (2014) Tx naive. Accessed Sof/Led through Dr Freeman at GP2U and Buyers Club (lifesavers!!!)
Commenced tx 12/11/15. 9 wk: VL <15 Detected but LFT = Normal 12 week results: UND (Yay!) Due to slow response commenced Sof/Dac 4 Feb for 12 weeks. EOT @ 24 weeks 27 April 2016. (With thanks to Dr Freeman et al). SVR11 result: VL 1,950,000. It's back!
New tx 030916 (Viekira Pak, Solvadi, Ribavirin UND @ 111116. EOT 170217.
SVR12 and SVR 24
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Sorry, but Australia is going to have to be Geoblocked 7 years 9 months ago #16877

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I don't often write to politicians but I think I will over this. I'm guessing that the TGA is part of the Health Minister's portfolio?
Genotype 1a
Diagnosed in 2004, had HCV for all my adult life. Until 2016!!!!
Harvoni treatment, started 19 March 2016
4 week results Bilirubin 12 down from 14 pre treatment,
Gamma 25 down from 52, ALT 19 down from 63, AST 19 down from 47,
VL <15 down from a lazy 6 million or so

EOT Results
Bilirubin 10, GGT 18, ALT 19, AST 21, VL UND

12 Weeks post EOT
Bilirubin 11, GGT 16, ALT 22, AST 20, VL UND
Cured baby
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Sorry, but Australia is going to have to be Geoblocked 7 years 9 months ago #16879

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Yes TGA is under Department of Health. Read all about them - www.tga.gov.au/sites/default/files/tga-b...s-plan-2015-2016.pdf
M 61yo HCV+ ~ 30 yrs Gt1a F2 VL 223,000 ALT 54 AST 42 Tx start Sof/Dac 17Dec15.
SVR4 at 7Apr16 ALT 22 AST 22
SVR12 at 9Jun16 ALT 23 AST 25
Melbourne, Australia
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Sorry, but Australia is going to have to be Geoblocked 7 years 9 months ago #16880

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Page11 - "advertising complaints responded to in a timely manner using a risk-based approach and measures taken to support compliance by advertisers".... So, who has complained?
Heading get down to page 21 it seems Dr Freeman is mitigating a known risk (public access to therapeutic products is restricted or delayed) but still is being hounded
Genotype 1a
Diagnosed in 2004, had HCV for all my adult life. Until 2016!!!!
Harvoni treatment, started 19 March 2016
4 week results Bilirubin 12 down from 14 pre treatment,
Gamma 25 down from 52, ALT 19 down from 63, AST 19 down from 47,
VL <15 down from a lazy 6 million or so

EOT Results
Bilirubin 10, GGT 18, ALT 19, AST 21, VL UND

12 Weeks post EOT
Bilirubin 11, GGT 16, ALT 22, AST 20, VL UND
Cured baby
The following user(s) said Thank You: GT2
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