Rituximab in Australia

[Sea]

Given that the Griffiths University team seem to be the most active in ME research, given they have a clinic and given that they have done some work on B cells, they seem to be the most likely to be interested in running a trial. They were also represented at the recent London conference I think and so will know all about the Rituximab trials.

I'm flagging some of you who I know are based in Australia. I know some of you are close to the Griffiths team. Is there any indication that they are thinking about a trial? Any ideas on how we might encourage them if the Phase 3 trial looks good? What would be the factors slowing down the establishment of such a trial - other than funding?

I haven't heard them mention Rituximab at all. The researchers are mostly PhD students, under supervision, looking for a breakthrough in finding a biomarker. I don't know if there will be any interest in treating based on others findings. I would imagine if Rituximab were made available to us it would be delivered by those who are already familiar with its use in other illnesses.

I haven't worked out yet what the point of their clinic is. They are not offering treatment of any kind. The Dr said they cannot discuss the research at the clinic appointment because they are funded separately (Clinic appointments are reimbursed by Medicare, research is Government grant funded)

 

[alex3619]

I don't know why anyone would expect the Griffith clinic to be cutting edge treatment oriented. That was not going to happen. Where it differs, I think, is that you are not likely to find a doc that says "ME, whats that?" like happened to me only a few years ago. We have not had a lot of stories from the clinic though.

As for research, they have mentioned Rituximab but only in passing. Its a maybe. To do that they would need a successful grant application.

 

[EtherSpin]

whilst I hope Griffith come up with a biomarker interviews early on did not encourage me about their potential for advocacy or expanding beyond their initial aim, too much sympathy for the 'CFS is not real' position from general public and medical professionals - the Griffith rep being interviewed said that because of the elusive nature of CFS these positions were very understandable rather than taking the opportunity to stand up for the patient population who are constantly undermined.

 

[redaxe]

whilst I hope Griffith come up with a biomarker interviews early on did not encourage me about their potential for advocacy or expanding beyond their initial aim, too much sympathy for the 'CFS is not real' position from general public and medical professionals - the Griffith rep being interviewed said that because of the elusive nature of CFS these positions were very understandable rather than taking the opportunity to stand up for the patient population who are constantly undermined.

A lot of it would depend on the resources their given; that means money and people.
If we want a Rituximab trial in Australia we need both the dollars and doctors/scientists experienced in Rituximab. From what Jonathon Edwards has said some time back regarding the UK - few doctors are comfortable in working with that drug. And that obviously makes it harder to have a large trial.

So yes part of the problem is public perception and still most of the doctors and treatment clinics for ME/CFS in Australia are holistic doctors and GET/CBT clinics for god sake!!!!!
We're not going to get anywhere until we get more immunologists on board. We seem to have followed the UK approach.

On that subject though are there any rituximab trials being planned in the USA? They have Stanford University (Montoya), Columbia Univeristy (Lipkin) and the Open Medicine Foundation all doing work on ME. It should be easier to get a trial going in the USA. They have a lot more researchers and scientists onboard now than ever before.

 

[Sea]

I don't know why anyone would expect the Griffith clinic to be cutting edge treatment oriented. That was not going to happen. Where it differs, I think, is that you are not likely to find a doc that says "ME, whats that?" like happened to me only a few years ago. We have not had a lot of stories from the clinic though.

The expectation came from the way the clinic has been promoted.

From their website:
https://www.griffith.edu.au/health/national-centre-neuroimmunology-emerging-diseases/clinic

Aims of the Clinic
The CFS/ME Specialised Clinic at Griffith University aims to provide individualised management and care to patients with CFS/ME.

Clinicians assess patients based on the following criteria:
§ clinical history
§ physical examination
§ blood sampling

An initial consultation will be used to determine if the patient meets currently accepted CFS/ME criteria, which will consist of consultation with an on-site registered nurse and a clinician with expertise in CFS/ME.Following the initial consultation, the patient may be:
§ referred to a specialist
§ scheduled for a follow-up appointment at a later date, based on clinical need.
Patients attending the clinic may also be invited to participate in research.Please note that this is not an out-patient clinic and a referral is required from your GP to attend.

And this from the Griffith uni website:
https://app.griffith.edu.au/news/20...cialised-clinic-for-chronic-fatigue-patients/

The Griffith Health Centre is home to the National Centre for Neuroimmunology and Emerging Diseases (NCNED), which is dedicated to research on the interaction between the nervous system and the immune system and is led by one of Australia’s foremost authorities on CFS, Professor Sonya Marshall-Gradisnik.

“We now have the capacity, not only for advanced research but also the potential to provide a clinical service to people who have been unable to find appropriate care in the past,” says Professor Marshall-Gradisnik.

“Our research is leading the way internationally to uncover the causes of this illness based on our unique immunological discoveries.”

 

[alex3619]

None of that actually says to expect cutting edge treatment. None of it. Its about not getting the usual very bad treatment, or that is how I interpret it. The research side may be cutting edge, but the clinical side is different. Doctors who blur the two get shut down by the health insurance watchdogs, though I do wonder if they could do it by going outside of medicare or private insurance, and with full fee.

In the early 90s I tried to take legal action against the insurance watchdogs via the Discrimation Tribunal. That however is a complicated story.

In any case there are no fully validated treatments for ME or CFS just now. It makes it hard for doctors to act. Now in patients with active viral infection they can use antivirals. Similarly for other issues for which treatments exist and are recognized.

What I was hoping for, and which appears not to be the case, is cutting edge immune testing. Sigh.

 

[AndyPandy]

well actually it could be much sooner (election) Abbott in my opinion was trying to wedge labor on a few topics that would allow him to paint them as soft on terrorist threats and knock them down in the polls so he could use the triggers he had sitting around to launch a double dissolution election. the other thing to watch, in the post spill party meeting he was warned to have the polls in better shape by september (they are similar,a little worse?) so he might try to preempt moves against him.

I like this stuff though, Rudds wife Therese actually tweeted my election graphics to her 40k+ followers on the night before the last election and Tony Burke has retweeted my stuff a couple of times. I want to meet with Jenny Macklin about DSP inadequacy at some point too - things like no super contributions for us when we are on something that (medical costs taken into account) is worse than minimum wage

Good on you @EtherSpin. My tip is a federal election before the next budget (May 2016). Budget figures won't be good. Anytime between now and then that appears opportune to the Government. Maybe even before MYEFO - around December?

 

[EtherSpin]

Maybe even before MYEFO - around December?

I think you are on the money, approx 3 weeks ago Hockey was questioned by Barrie Cassidy about whether he would deliver a third budget and hockey laughed and refused to answer - some of the signs they put up in Melbourne about East-West link and Labor are pretty transparent as federal campaign ads.

I was a bit desperate in 2013, it was before I got all my BP meds sorted to be able to be upright and I was getting serious PEM just from the trip to my CFS doctor - they use video conferencing (two of my doctors do actually) and we were due to get fibre to the home in early 2014 if the government hadnt changed,our court has particularly bad copper wires - we arent even marked at all on the rollout map now so as soon as the election is announced or more policy is described by the majors I'll get out the tablet again and get working on pro PWME / general disability propaganda

does anybody know of an MP in the coalition, labor party or greens with a close relative or other personal experience of CFS ?

 

[AndyPandy]

Yeah we disappeared from the rollout map too.

Maintain the pro PWME/Disability rage!

 

[Sea]

In any case there are no fully validated treatments for ME or CFS just now. It makes it hard for doctors to act. Now in patients with active viral infection they can use antivirals. Similarly for other issues for which treatments exist and are recognized.

That is true, but if they don't test they can't treat. I have not had viral testing and I wasn't offered any further testing at the clinic.

What I was hoping for, and which appears not to be the case, is cutting edge immune testing. Sigh.

Yep, me too. Hopefully it is coming in the not too distant future.

 

[alex3619]

That is true, but if they don't test they can't treat. I have not had viral testing and I wasn't offered any further testing at the clinic.

You can get viral testing. Proper viral testing used to cost about $1200, that's a discounted test price from some years back, but its cash only. Most insurance here might not cover it except under very specific circumstances. Antibody testing is a lot cheaper. Its hard to be sure if you have eradicated a virus using antibody testing, all you can say is that you might not have had the virus, and you probably don't have an acute infection.

That is a huge problem with the Australian system. The rules under which tests are covered, especially by our Medicare etc., are very strict.

Which is one problem we might have with rolling out Rituximab, or trials. Some viral infections contraindicate the use of Rituximab. If we have never been tested then how can we know if Rituximab is safe for us?

 

[Sea]

You can get viral testing. Proper viral testing used to cost about $1200, that's a discounted test price from some years back, but its cash only. Most insurance here might not cover it except under very specific circumstances. Antibody testing is a lot cheaper. Its hard to be sure if you have eradicated a virus using antibody testing, all you can say is that you might not have had the virus, and you probably don't have an acute infection.

In theory I can get viral testing. In reality I have had to push hard for every test I've had and I still don't have a doctor who knows anything about ME/CFS.

What is the viral testing you mentioned? I didn't know there were tests other than antibody tests. I would travel and pay for testing if I knew where to go.

 

[alex3619]

What is the viral testing you mentioned? I didn't know there were tests other than antibody tests. I would travel and pay for testing if I knew where to go.

Many large hospitals can give you viral titres. These measure how much of a virus, not the antibodies, are in the blood. Its very expensive though.

 

[redaxe]

Many large hospitals can give you viral titres. These measure how much of a virus, not the antibodies, are in the blood. Its very expensive though.

Can you please elaborate on that? When you mean viral titres are you referring to a PCR or is another form of test.

I gather the problem with ME/CFS is that viruses are generally unlikely to be present in the blood - at least that's what Lipkins study showed. Which is why they want to look deeper into the tissues - do hospitals have the means to do that sort of testing?

 

[alex3619]

No, not PCR. They use something that I think (my knowledge is out of date and this was years ago i was looking into this) a high throughput scintilographer. Basically they tag antibodies that are specific for a virus with a fluorescent part, add them to your blood, then pass the blood through the machine. It counts how many times it gets a light flash.

Most hospitals don't do tissue testing, especially not without cause.

PCR can be used though, but I think its hard to get viral titres from it.

Mostly to get an idea on tissue I think they still stain it with specific antibodies and a marker attached to the antibody, then use a light or other microscope. Again, I am a decade out of date on this stuff now.

 

[redaxe]

I see - that's sounds expensive. I doubt any doctors would gives us that unless we presented with obvious infectious related life-threatening symptoms.

Edit - regarding PCR does it give more accurate information if it is run using Cerebral Spinal Fluid?

 

[alicec]

I haven't worked out yet what the point of their clinic is.

Me either. I was totally underwhelmed by my visit there at the beginning of the year. Fortunately I didn't have high expectations so wasn't disappointed.

The only useful purpose I could see was for someone in the early stages of the disease or unsure of diagnosis - I imagine they would at least get sympathetic diagnosis here. They claim to offer individualised management plans so again this might be helpful for such a person. In my case they simply said they couldn't suggest anything I wasn't already doing.

What I was hoping for, and which appears not to be the case, is cutting edge immune testing. Sigh.

Yep, me too. Hopefully it is coming in the not too distant future.

Me three but all that was offered to me was FACS analysis of NK and Treg cells sometime in the future. Their results to date showed that the former were reduced and the latter were elevated in CFS/ME patients and there was a suggestion that this latter finding could be linked to an autoimmune response. On reflection later I thought the opposite might happen if an autoimmune process was going on but in any case they didn't follow up with me and I didn't bother to pursue it.

My impression was that they were extremely conservative and minimalist in their approach so I wouldn't be holding my breath about their taking an initiative with Rituximab.

 

[hixxy]

@alex3619
i think NCNED are mostly looking into ways to diagnose cfs/me with proper biomarkers etc.

NCNED is also looking at treatment. I've heard not so long ago that they will be starting in vitro experimentation with drugs to treat ME/CFS. So they may have already started this process.

 

[Lynne B]

Hi, all,

I see that much of this thread is several months old, however, this is just a point about info on Google: I just typed non hodgkin's lymphoma + rituximab + australia and got lots of sites. From it I understand that Ritux is currently being used in Australia for rheumatoid arthritis and non-hodgkin's lymphoma plus one other form of leukemia. Trials are currently recruiting at several sites such as Concord hospital, for ritux treatment of lymphomas such as non-hodgkin's etc. (I only skimmed, don't have much time. Roche was mentioned in auspar-rituximab-130813.docx, etc.

Worth a look.

Cheers,

 

[alex3619]

Rituximab has been used here for a long time. Its just not been used for ME.

On PCR, its only about detecting the presence of viral RNA/DNA etc. Its not about titres.The kind of technology that used to be available for PCR simply gave you a yes or no ... its there or its not. It does not tell you about severity or titres, unless there is something new I do not know about.

Due to the way that viral nucleic acids are amplifed ( cloned) in PCR, in order to raise numbers, its almost impossible to do a reverse analysis and be sure of original numbers. That requires other technology.

In vitro testing, such as NCNED might be doing, is many many years away from clinical use even if successful. Unless the drug is already safety approved, in which case things can be fast-tracked, it will be many years to a decade or two for a new drug to be approved. In some cases this can be fast-tracked, but that requires substantive political will.

By new drug I mean a new drug for clinical use. Many (most?) drugs are not approved, and not used clinically, but still available for research - though I suspect not easily available for human trials. There are lots of steps between in vitro research and clinical trials. I will likely hit retirement age before such a drug is available.

Now, if its repurposing an already approved drug, that can be just a few years from testing to trials to public use. My best guess is that it will still be about five years or so. However some doctors might be happy to prescribe such a drug for off-label use much earlier than regular approval is granted.