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New Rituximab ME/CFS open-label phase II study with rituximab maintenance treatment

charles shepherd

Senior Member
Messages
2,239
The problem with this statement is, if it's easily available for patients with lymphoma, and in rheumatology, and if governments and insurance companies approve if for these conditions, if it's deemed appropriate and indicated for patients with ME who might actually return to their productive and thriving living, then why is "very expensive drug" a problem? Why are patients with ME not worthy of a treatment that has 2 chances out of 3 to be successful? It is better than lottery!

There are therapies out there which cost much more, for intance the new drugs for Hepatite C, for which my government approved last month.

We are worth the investment. And please leave it to patients to decide whether the potential side effects are worth the risk. An informed decision as part of the consent to treatment is important. Patients ned to read the 'fine print'.

At the local clinic, the bio-psycho-social approach reigns. Definitely, this is a cheaper model than offering treatments like Ampligen, Valcyte, IVIg and Rituximab.

Food for thought. we are worthy of serious medical treatments.

Kati

The very basic point I was making in this short MEA press statement, certainly in relation to the future possible use of Rituximab as a treatment for ME/CFS here in the UK, is that this is an expensive drug in relation to most drugs that doctors prescribe on the NHS and it does have a potential to cause serious side effects - although it appears to be generally well tolerated by those involved in the Norwegian clinical trials.

So as far as the UK is concerned, the bodies that license medicines and recommend their use in specific conditions (ie NICE) will need good quality replicated evidence relating to both efficacy and safety from some large multicentre (phase 3) clinical trials before people with ME/CFS could have access to Rituximab.

Large scale phase 3 trials are very costly to set up and in the case of Rituximab, where evidence on longer term maintainance treatment would also be required, this means that from start to finish and publication of results you may well be looking at three years.

So I think we need to be persuading someone who could afford to fund a decent phase 3 clinical trial to do so here in the UK....sooner rather than later and certainly before late 2017/early 2018 when we will hopefully have the results of the phase 3 Norwegian trial that is now in progress.

And if we have the whole spectrum of medical opinion on board here, including the psychiatrists, then the prospect of setting up a phase 3 trial here in the UK does look far more encouraging.

If this doesn't happen, it could well be 2020 before people in the UK start to benefit from the first effective form of drug treatment aimed at the underlying disease process in ME/CFS,
 

Kati

Patient in training
Messages
5,497
Kati

The very basic point I was making in this short MEA press statement, certainly in relation to the future possible use of Rituximab as a treatment for ME/CFS here in the UK, is that this is an expensive drug in relation to most drugs that doctors prescribe on the NHS and it does have a potential to cause serious side effects - although it appears to be generally well tolerated by those involved in the Norwegian clinical trials.

So as far as the UK is concerned, the bodies that license medicines and recommend their use in specific conditions (ie NICE) will need good quality replicated evidence relating to both efficacy and safety from some large multicentre (phase 3) clinical trials before people with ME/CFS could have access to Rituximab.

Large scale phase 3 trials are very costly to set up and in the case of Rituximab, where evidence on longer term maintainance treatment would also be required, this means that from start to finish and publication of results you may well be looking at three years.

So I think we need to be persuading someone who could afford to fund a decent phase 3 clinical trial to do so here in the UK....sooner rather than later and certainly before late 2017/early 2018 when we will hopefully have the results of the phase 3 Norwegian trial that is now in progress.

And if we have the whole spectrum of medical opinion on board here, including the psychiatrists, then the prospect of setting up a phase 3 trial here in the UK does look far more encouraging.

If this doesn't happen, it could well be 2020 before people in the UK start to benefit from the first effective form of drug treatment aimed at the underlying disease process in ME/CFS,

Hi @charles shepherd I thank you for your answer.

It is very sad that countries such as UK and Canada need to look at cost of treatments when it comes to deciding on a potential effective treatment for patients with ME. Here in British Columbia the terminology 'sustainable health care' is increasingly popular when it comes to approving new therapies and treatments and in terms of health policy.

But this ideology is somehow skewed from what is already funded and cuts to these programs (cancer, HIV, Hep C, etc) is not going to happen. However the policy of sustainable health care comes on full force when it comes to ME, FM and Lyme. Undeniably it costs much less to not fund biomedical treatments for these populations. So let's offer them a holistic model. Let it be meditation, acupuncture, learning how to eat right and learning how to cope with what you got. Cheap, and that sends the message back to the patients that it's their own fault and they have to take responsibility for perpetuation of symptoms.

Sustainable? as long as there are customers, I guess so. Ethical? Not one bit. Fair? Not one bit.

Good science (and good moral) must always prevail.

Medicine works on what's effective. No one question just one bit how much it costs for the HIV drug therapy. No one would actually decide on a cheaper but compromising regimen. There is so much ingrained double standards with patients with ME.

'Too expensive' 'too risky' '
Thing is the research coming from Norway is the best we've had ever in our disease history. It is very inconvenient for governments and for policy makers. We shouldn't have to settle for cheap and useless treatments.
 
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snowathlete

Senior Member
Messages
5,374
Location
UK
Anyone want a good laugh? This comes from @Firestormm on Twitter:

View attachment 11705


It seems we have reached an important threshold with this study where denial is no longer seen as tenable. Simon Wesley is ahead of the curve; some will hold onto their sinking positions longer yet. Most will eventually adapt their stance and claim they always said that sufferers should be "taken seriously," - which sounds good but ignores all the important facts. Such a tragedy. And in a similar way to Orwell's 1984 it will soon become hard for people to be sure of the truth regarding what really happened; what individuals actually said and did.
 

snowathlete

Senior Member
Messages
5,374
Location
UK
I think it was a good move to include those patients from the placebo group in the first study in this subsiquent open label study. Not only good from a ethical point of view, but because it strengthens the case that it really is the drug creating this result.

Regarding cost, I dont think it is an expensive drug at all when you consider that it is a drug for a chronic and debilitating disease. It's expensive in comparision to say a round of antibiotics for an accute bacterial infection but that's not what we should be comparing against here. It's expensive in comparrison to say insulin for diabetes, but then diabetics have lots of other medical needs which require drugs and surgeries and care and so on. I expect the yearly cost for most diabetics would be much higher than ME/CFS patients if they were given rituximab. So it's really not expensive at all from the government point of view. Of course, on a personal level it is out of most people's price range, so access to the drug may well depend on where you live and what the medical system is like there. I do accept Charles Sheperd's point that the liklihood of NICE aproving the drug in the UK, goes up the more robust evidence we have that the drug delivers a worthwhile benefit. I think we need to be proactive about achieving what we want to achieve in that area and not wait until the phase III trial is complete before taking action, so pleased to see the MEA thinking about that already.
 

SOC

Senior Member
Messages
7,849
Does anyone else find it a bit odd that Lerner also reported a 66% response rate for his antiviral protocol?
Not particularly. My guess is that approximately a third of the people currently diagnosed with ME/CFS, even under the best definitions we have, have a different illness than the other two thirds. In both cases the illness is very serious. The symptoms are similar, possibly because of secondary effects (inflammation, cytokines, neurological impacts), but the root of the illnesses may be different.

For example (not saying I think this IS the case, just pointing out how it COULD happen), if chronic EBV were the root cause for 2/3 of ME/CFS patients, antivirals and B-cell depletion might help them, while if Lyme was at the root of the other 1/3 of cases, those treatments might not help, but the right antibiotic treatment might. I'm sure the real situation is a great deal more complex, but the point is that the 67%/33% pattern we're seeing could simply be an indicator of subsets (or distinct conditions).
 

SDSue

Southeast
Messages
1,066
Maybe he needs to see a psychiatrist
Best laugh in days. :rofl:

Does anyone in Norway want to marry me? :p
When you find a candidate, please make sure they are into polygamy - we can all go to Norway together! :lol:

Given that now even Simon Wessely is saying there might be something to this, we might not have to wait that long.
What! Wait just a second. Was Alex just optimistic about the timing of treatment possibilities? Surely hell hath frozen over! ;)
 

Nielk

Senior Member
Messages
6,970
Just because a specific medicine works for one patient but not the other doesn't mean that they suffer from different diseases.
Take for example Rituxumab for RA only works for 70% of RA patients. As a matter of fact it is not unusual for an RA patient to try 4 or 5 RA meds until they find one that works.
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
I think we need to be proactive about achieving what we want to achieve in that area and not wait until the phase III trial is complete before taking action, so pleased to see the MEA thinking about that already.
It took many years for antibiotics to be used for H. pylori induced gastric ulcers. This arose because of huge numbers of patients insisting on it. The science is part of it. WE are the other part. With something substantial to fight for, advocacy will have a very tightly focused goal.
 

barbc56

Senior Member
Messages
3,657
This is incredible news even for those of us who may not qualify. It's hope and it's grounded in science! That's a biggie and will hopefully convince many doubters. I would drink a toast if I could tolerate alcohol so maybe I'll have some chocolate instead,

I also find it reassuring that they are reading the work of others, notably Lipkin, Maes and Gottfries.

Well I hope they are reading Lipkin. That's a big plus! He pulls a lot of weight in the scientific world which is what we need. His dedication is truely appreciated!

I have to look up Gottfries. I just might not be recognizing his name

@Firestormm

You are missed! Thanks for the tweet!

Barb

ETA Deleted comment about a researcher I may have misidentkfied.:bang-head::bang-head:
 
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alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
Thing is the research coming from Norway is the best we've had ever in our disease history. It is very inconvenient for governments and for policy makers. We shouldn't have to settle for cheap and useless treatments.
Nor should society. These useless treatments actually cost society much more as patients are just parked in the Cant Cure Zone, with all associated costs. Its not just patients who suffer, its everyone.
 

lansbergen

Senior Member
Messages
2,512
Not particularly. My guess is that approximately a third of the people currently diagnosed with ME/CFS, even under the best definitions we have, have a different illness than the other two thirds. In both cases the illness is very serious. The symptoms are similar, possibly because of secondary effects (inflammation, cytokines, neurological impacts), but the root of the illnesses may be different.

Or the disease process has more progressed or taken a different turn. .
 

medfeb

Senior Member
Messages
491
If I understand the ClinicalTrials.Gov record, it looks like this trial is not being funded by the pharmaceutical industry. Is that correct?

At some point, I'd expect them to get interested once there is some reasonable demonstration of proof of concept, clear mechanism to define the disease and also agreement on how to measure treatment efficacy. How close are we to that with the work that's being done in Norway? At least in the U.S., I'd think it would be difficult to get the studies needed for approval until pharmaceutical companies get involved.

Edit
I know that costs can vary for Rituxan in the U.S. - my son's cost 8500 per infusion (1000 g) including infusion costs, which I think is about $500.
 

Denise

Senior Member
Messages
1,095
@medfeb - With the patent on Rituxan set to expire this year (don't know exactly when), would that particular pharma company still be interested in funding/have time to fund studies of Rituxan as a means of possibly extending their patent?
 

Nielk

Senior Member
Messages
6,970
@medfeb - With the patent on Rituxan set to expire this year (don't know exactly when), would that particular pharma company still be interested in funding/have time to fund studies of Rituxan as a means of possibly extending their patent?
I heard that because of the patent expiration, it would not pay for them to invest money in trials. Is it possible to extend a patent?
 

Sean

Senior Member
Messages
7,378
Sounds promising so far. :thumbsup:

Even if Rituximab turns out to not be a great treatment, it is sure giving us some important clues.

I see his [Wessely's] quotes and I really just want to slap the dude.
Wessely must not be allowed to get away with rewriting history to make himself look good and avoid accountability. The thought of him riding to glory (or at least safety) on the back of the hard work by other people on underlying biomedical processes, is just appalling, given his track record over the last 30 years of extreme partisan propagandising for a primary psychosomatic explanation, and the consequences that has had for science, patients, and broader society. :depressed::depressed::depressed:

Weasels and sinking ships. :meh::meh::meh: