Looking Ahead to obtaining Rituximab Treatment

[OverTheHills]

I am hoping, providing the UK & Norwegian studies turn out as expected, to try Rituximab in 1-3 years time.

I am in my mid 50s and have had ME/CFS for 10-12 years depending on where you count the start point. My appetite for risk is increasing as I age and therefore don't have as many more good quality years to hope for. So I am thinking to go for Ritux not wait for better treatments to be identified further down the line.

I'd like to suggest this thread to discuss/speculate on the realities/issues of making that happen. Also to think about anything we patients need to organise, prepare or lobby for.

For example: where? will any NZ rheumies be prepared to do this? I can enquire of Dr Vallings who runs the national ME society here. Otherwise it will be UK or US depending on cost. UK might be preferable as the experience of the first trial will already be there.

Paying: I expect public health services/insurance companies will regard the treatment as experimental for some years so if I can't get in on a study I will need to fund it privately. I am prepared to mortgage house/cash in pension/take a loan.

Paying 2: Is there a way to get an extra research bang for our buck if patients club together? ie leveraging some research extra from early adopters rather than our individual experiences being mere anecdote? Obviously there would be all sorts of selection bias/control issues but is there anything this sort of data could help explore - such as comparing different dosing schedules or adjunct treatments (non scientist - you can tell right?).

Any answers/other questions?
OTH

 

[daisybell]

I'm thinking like you...!
Have just arranged to see Dr V to ask about treatment options here in NZ... and am also thinking seriously about leaving to go to the UK. I want to be as close as possible to the front of the queue if Rituximab becomes a possibility. Beg, borrow, steal.....

 

[OverTheHills]

I'm thinking like you...!
Have just arranged to see Dr V to ask about treatment options here in NZ... and am also thinking seriously about leaving to go to the UK. I want to be as close as possible to the front of the queue if Rituximab becomes a possibility. Beg, borrow, steal.....

You go for it Daisybell. Can you post or PM me when you have spoken to her? No point in us all asking the same thing individually.

I'm thinking I will most likely end up in UK (being a Brit should make it easier). We can queue together and have a PR queue party

 

[Little Bluestem]

I am not a scientist either, but I think that trial get bigger as they go along. You might ask what the chances are of getting one of the next round of trials done in NZ (with you two as the first two participants admitted).

 

[OverTheHills]

No-one else from anywhere else speculating and plotting about Rituximab treatment?

 

[ukxmrv]

I've been speculating for years. Not in NZ of course, but in the UK. 1-3 years is a little optimistic maybe? There are plenty of patients travelling to the USA for tx or in the USA. However, if you follow their progress it's not be too positive so far. Obviously we don't always hear from them.

If you do get a trial set up in NZ there is no guarantee that you will be selected as patients. It would take years sadly.

As far as I know NZ has never funded a research treatment trial into anything for ME or CFS. The only person doing research now is Dr Tate? Otago Medical School/ Uni/ Professor Murdoch would be good people to talk to.

A quicker /cheaper option might be to see if there is a clinic in Thailand or similar that could do the infusion for you cheaply?

 

[snowathlete]

I'm not convinced the UK is the place to go, except for the possibility of getting on a trial. It's a heavy drug. Well worth the risk you can argue, from the patients point of view, but there's regulation in the UK and with the way the NHS currently looks at ME, you'd have to be mad to be a doc in the UK offering Rituximab before trials have finished and been published and ultimately, replicated.

The Norway trial is, if my iffy memory is right, two years from completion then another year till publication. Have the UK trials even started recruiting yet? Probably a year behind weigh those initial results. Will that be enough?

Once enough trials have finished, NICE will drag their heels for a year or more. There may be some UK docs willing to offer it privately in that time I guess but that's got to be four or five years away, best case, I'd have thought...

I'd explore options elsewhere if it was me. Eastern Europe?

 

[deleder2k]

I think 1-3 years is not very realistic. It will probably take another 3 years before the phase 3 study from Norway is completed. After it is published, I believe that treatment can start rather quickly in Norway.
I hope that some private clinic can start treating people with it. It is not a new drug, and we know it works. I don't understand why some clinic in India or something haven't started treatment with rtx.

 

[vli]

I don't understand why some clinic in India or something haven't started treatment with rtx.

Perhaps because ME is rarely diagnosed in India?

I am from Hong Kong and I can tell you that ME is basically never diagnosed in HK/China. Most doctors do not even know the name for it.

 

[deleder2k]

Perhaps because ME is rarely diagnosed in India?

I am from Hong Kong and I can tell you that ME is basically never diagnosed in HK/China. Most doctors do not even know the name for it.

India was just an example. I just recall that a few Norwegians with progressive M.S went there to receive stem cell therapy.

 

[alex3619]

I have raised this issue a few times in various threads. I am glad we now have one devoted to it.

My guess is that for most we will not get access for at least 3-5 years. Even then we might have to pay cash. Insurance might not cover it for an additional time period.

So there are issues on the science, on the medical use of it, and on the cost and reimbursement of it. All of these involve different questions.

I will say more later.

 

[deleder2k]

Compared to the benefit of Rituximab, it is cheap. Very cheap. Remember that one can get Rituximab for Psoriasis in many countries.

 

[OverTheHills]

I think 1-3 years is not very realistic. It will probably take another 3 years before the phase 3 study from Norway is completed. After it is published, I believe that treatment can start rather quickly in Norway.
I hope that some private clinic can start treating people with it. It is not a new drug, and we know it works. I don't understand why some clinic in India or something haven't started treatment with rtx.

I am sure you are all right thinking either a trial or a private clinic is the only way to go to get treatment on a 3 year timescale.

I don't see public/mainstream health providers jumping into this early and I don't think NZ will be a leader in this because our population base is small. How on earth did Norway manage to be a leader with 5 million people? have you got a particularly strong track record in medical research or are you just lucky with Fluge and Mella?

I'm a bit wary of going to random places to get Ritux cheaply, I wouldn't know how to judge their experience with using it. Is that foolish?

It is interesting that only one of our existing ME/CFS clinicians is showing signs of offering Ritux as a treatment option. I suppose when more start doing that I'll know its time to phone the bank for a loan.

Thanks for the replies guys. I just want to talk about it, its so hopeful.
OTH

 

[ukxmrv]

Perhaps because ME is rarely diagnosed in India?

I am from Hong Kong and I can tell you that ME is basically never diagnosed in HK/China. Most doctors do not even know the name for it.

I was thinking of India because they make cheap generic drugs. One of the Indian companies currently has a tie-in with a large international drug company to make one. I think it might be Dr Reddy's but there are other Indian drug companies.

http://www.bloomberg.com/news/2013-...oche-s-rituxan-in-europe-corporate-india.html

http://www.medindia.net/doctors/drug_information/rituximab.htm

Wasn't Rituximab coming to the end of it's license or something soon, which was why we were told that the drug companies wouldn't be interested in funding trials?

 

[deleder2k]

I am sure you are all right thinking either a trial or a private clinic is the only way to go to get treatment on a 3 year timescale.

I don't see public/mainstream health providers jumping into this early and I don't think NZ will be a leader in this because our population base is small. How on earth did Norway manage to be a leader with 5 million people? have you got a particularly strong track record in medical research or are you just lucky with Fluge and Mella?

I'm a bit wary of going to random places to get Ritux cheaply, I wouldn't know how to judge their experience with using it. Is that foolish?

It is interesting that only one of our existing ME/CFS clinicians is showing signs of offering Ritux as a treatment option. I suppose when more start doing that I'll know its time to phone the bank for a loan.

Thanks for the replies guys. I just want to talk about it, its so hopeful.
OTH

They had a patient with lymphoma and ME/CFS. Chemotherapy made her CFS go away for a while. Pure luck
I am very happy that they continued to pursue the idea that it was the killing of b-cells that caused the remission.

 

[ukxmrv]

Norway has the oil money and is a wealthy country but unlike other doctors when faced with a patient who had a change in her CFS symptoms they (Fluge and Mella) paid attention to this and decided to do something.

Have a look at how Rituximab is licensed in New Zealand. It may be running out of it's patent.

New Zealand isn't a third world country and you need to be asking questions about why ME patients aren't getting treatment. NZ was the first country in the world to give women the vote. They have a system of compensating injured people - so why are people sick with ME being ignored?

If the results of the Rituximab continue to be good I'll be looking at countries to supply it. Buy other drugs from India.

At this time of my life and after 30 years of non-stop ME I am willing to take chances - after doing my homework first of course.

 

[catly]

They had a patient with lymphoma and ME/CFS. Chemotherapy made her CFS go away for a while. Pure luck
I am very happy that they continued to pursue the idea that it was the killing of b-cells that caused the remission.

Doesn't either Fluge or Mella also have a sister-in-law with ME? I seem to recall reading that on one of thier presentations. I think a lot of Drs. that take interest in research and treatment of MECFS patients do so because of some sort of personal connection to the illeness.

 

[deleder2k]

Olav Mella had a sister-in-law, but she passed away before the discovery.

He mentiones it here: Olav Mella speaks about the Rituximab study and ME/CFS future 12.05.2014

 

[daisybell]

Norway has the oil money and is a wealthy country but unlike other doctors when faced with a patient who had a change in her CFS symptoms they (Fluge and Mella) paid attention to this and decided to do something.

Have a look at how Rituximab is licensed in New Zealand. It may be running out of it's patent.

New Zealand isn't a third world country and you need to be asking questions about why ME patients aren't getting treatment. NZ was the first country in the world to give women the vote. They have a system of compensating injured people - so why are people sick with ME being ignored?

If the results of the Rituximab continue to be good I'll be looking at countries to supply it. Buy other drugs from India.

At this time of my life and after 30 years of non-stop ME I am willing to take chances - after doing my homework first of course.

Unfortunately, the majority of doctors in NZ still view ME as a psychosomatic problem, and apart from Warren Tate at Otago Uni, I don't know of anyone with research interest. Plus Pharmac, who fund medicines will I think take a hard line on Rituximab.

I think our chances are better overseas!

 

[OverTheHills]

Also there appears to be no advocacy base in NZ. As far as I can see our national ME organisation takes a.... 'softly softly' approach not a lobbying or confrontational one. I'd happily add my voice if there were more pushy people but I don't feel like I can take a national leadership role.

Happy to be proved wrong if there are activists and I just haven't heard about them.
OTH