Good ME/CFS doctors in Norway?

[Jesse2233]

Does anyone know of any good CFS doctors in Norway?

Obviously Fluge and Mella are there, but as I understand they're researchers and not clinicians.

I found out yesterday that the Ampligen Cost Recovery program has been canceled in the US, I'm considering relocating to Norway because Ampligen is now approved for early access in Europe and I have family in Oslo who could help me.

 

[deleder2k]

I have never heard of anyone in Norway ever getting Ampligen. Please update us if you find a place to buy it, and if you get to know what the price is.

With respect to doctors, there are a few in Oslo that are good. But if you expect them to give you IV of Ampligen, I think you will be disappointed. If you just need a regular doc to do common blood tests and get you medicines to treat sleep/pain and so on you won't have any major issues.

The only doctor that I know of that would consider Ampligen would be dr. Øgreid at Kolibri Medical outside Stavanger in Western Norway. A short 45m flight from Oslo. Kolibri is a private clinic/small hospital that has been treating approximately 200 patients with rituximab. I think it is the only place in the Western world in addition to Open Medicine Institute that does that.

May I ask if you have tried Ampligen before? What about rituximab?

 

[Jesse2233]

Thanks @deleder2k for that run down, it's very helpful.

I've not taken Ampligen or Rituximab, but am interested in both because they have peer reviewed studies showing some efficacy

 

[TrixieStix]

Does anyone know of any good CFS doctors in Norway?

Obviously Fluge and Mella are there, but as I understand they're researchers and not clinicians.

I found out yesterday that the Ampligen Cost Recovery program has been canceled in the US, I'm considering relocating to Norway because Ampligen is now approved for early access in Europe and I have family in Oslo who could help me.

Do be aware that as an american you can only stay in Norway a maximum of 90 days out of every 180 days. So for instance if you stayed there for 90 days straight you would then be required to leave and would not be allowed back into the country until another 90 days had passed. If you need to stay longer than 90 days I would find out if you can apply to the Norwegian government for a non-working visitors visa that would allow you to stay longer than the 90 days based on you being able to prove you have family there to stay with and enough income to support yourself while there.

 

[deleder2k]

I don't know much about Ampligen. I read this and it doesn't look too good: http://forums.phoenixrising.me/inde...od-ampligen-in-the-treatment-of-cfs-me.43961/

And you need regular infusions, don't you? If you respond to Rituximab you can possibly go on after the treatment for a few years in remission. A very small number looks like they are cured. Those that have an effect looks to at least have effect for an year or so. Other patients gradually relapse after 2-3-4 years. I would advise you to read both rituximab studies.

 

[TrixieStix]

I personally think we will know much more about Rituximab's efficacy in PWME and what differentiates responders from non-responders once Fluge & Mella release their clinical trial results next year. Fingers crossed!

 

[deleder2k]

I personally think we will know much more about Rituximab's efficacy in PWME and what differentiates responders from non-responders once Fluge & Mella release their clinical trial results next year. Fingers crossed!

I hope so. I think several researchers are investigating this. I hope and think that someone will be able to predict whether one will respond or not. Lets hope it will be a test that can be made available to the public fast.

 

[Jesse2233]

I don't know much about Ampligen. I read this and it doesn't look too good: http://forums.phoenixrising.me/inde...od-ampligen-in-the-treatment-of-cfs-me.43961/

And you need regular infusions, don't you? If you respond to Rituximab you can possibly go on after the treatment for a few years in remission. A very small number looks like they are cured. Those that have an effect looks to at least have effect for an year or so. Other patients gradually relapse after 2-3-4 years. I would advise you to read both rituximab studies.

Thanks @deleder2k yes I've read the studies.

Since Rituximab has some risks, my plan is to wait on the Phase 3 results and on when more practitioners become familiar with using it for CFS/ME.

In the meantime I'd like to try Ampligen to regain some functionality since it's the only other drug with substantial (albeit somewhat flawed) peer reviewed studies

 

[deleder2k]

But what are the cost of Ampligen? And do we know that it is safer than Rituximab? Rituximab has been a drug that has been used for more than twenty years. It seems like severe side effects are extremely rare in autoimmune diseases.

Ampligen requires two infusions a week, doesn't it? I don't know what state you're in, but getting to the hospital twice a week would have been very fatiguing for me. I don't know the cost of Ampligen, but I imagine that two infusions a week would cost several thousand dollars just in I.V costs per month.

If you were to consider Rituximab the price of the drug looks to under 50% in Norway compared to the US. I calculated the costs of getting RTX at the OMI in CA, and the total "package" with drug, infusions ++ was around 35-40% in Norway compared to getting it at the OMI (with no insurance).

 

[Jesse2233]

Hmm I didn't know about the reduced price in Norway. My understanding is that Ampligen and Rituximab are both ~$40k / year. And yes the twice a week IV infusions for Ampligen are limiting but doable for me with the right support. As far as side effects go Ampligen does have substantial ones, but I've not heard of anyone dying from using it and there are some rare reports of that with Rituximab

 

[deleder2k]

I think approximately 250 patients has been treated with Rituximab in Norway. No serious side effects reported. The most scary side effect with Rituximab is PML, but I don't know if one has seen that in patients that has cancer and is being treated with a cocktail of chemotherapy.

To my knowledge we know much more about the safety profile of Rituximab compared to Ampligen. Perhaps @Jonathan Edwards can elaborate.

Rituximab in Norway is priced at $1629 for 500mg, while it is priced at $4200 in the US. Infusion costs are also way cheaper in Norway (at least compared to OMI).

The the total price of treatment in Norway with accordance to the phase 3 trial design is roughly $19k (includes infusion cost + rituximab).

 

[Jesse2233]

Here's the breakdown as I see it

Rituximab

Pros:

-50-60% effectiveness
-excellent research team
-can produce full recovery
-FDA approved
-widely available drug
-only needed a few times a year
-safe in most cases

Cons:

-only Phase 2 results
-short track record of use (for CFS/ME)
-deadly in rare cases
-some unpleasant common side effects
-not widely available as treatment option (for CFS/ME)
-few positive anecedotal accounts
-expensive
-can make some people worse


Ampligen

Pros:

-30-70% effectiveness
-can produce near recovery
-many positive anecdotal accounts
-long track record of use
-safe in most cases

Cons:

-not FDA approved
-not widely available
-questionable company/research team
-some unpleasant common side effects
-requires two IVs a week
-expensive
-can make some people worse

 

[Jesse2233]

o my knowledge we know much more about the safety profile of Rituximab compared to Ampligen. Perhaps @Jonathan Edwards can elaborate.

Would be interested to hear his feedback on both drugs as well!

 

[Jonathan Edwards]

Would be interested to hear his feedback on both drugs as well!

Rituximab produces no significant side effects in the great majority of people if given by experienced staff. Probably the commonest serious side effect is pneumonitis, which may occur reasonably commonly (maybe one person in fifty or even one twenty). PML occurs in patients receiving other cytotoxic drugs. There may be a handful of cases of autoimmune disease where rituximab seems to be the only risk factor but the incidence is probably even then in the 1:10,000 range (aspirin is as dangerous as that). I do not take the risks of rituximab lightly but I think it is a drug well worth using where there is good evidence of efficacy.

Ampligen I know very little about and I doubt we have anything like the data (tens or hundreds of thousands of rituximab courses have been given). It may be very safe, but that may be because it does not have any significant effect on the immune system anyway. I have to say I do not understand the science behind ampligen if there is any. It seems to be an orphan drug that has ended up with ME/CFS because it has failed in all other situations.

 

[Gingergrrl]

PML occurs in patients receiving other cytotoxic drugs. There may be a handful of cases of autoimmune disease where rituximab seems to be the only risk factor but the incidence is probably even then in the 1:10,000 range (aspirin is as dangerous as that).

Dr. Edwards, I just want to make sure I am understanding this 100% correctly... so in your experience with RTX, the cases of PML were cancer patients who were receiving other cytotoxic drugs at the same time (versus autoimmune patients who were only receiving RTX)? Is this correct? If so, it matches with what my doctor and the nurses at my infusion center (which is a cancer center but I get IVIG there) are saying. And I like your comparison b/c I am allergic to aspirin, and it would for sure be dangerous if I took it, vs. RTX (if I am not allergic) could be okay.

ETA: The test I am going to do is called "Stratify JCV Antibody" (blood test). I know it does not predict someone's risk for PML vs. just past exposure to the JC virus. Do you have any thoughts about or familiarity with this test? Thank you in advance!

 

[Jonathan Edwards]

Dr. Edwards, I just want to make sure I am understanding this 100% correctly... so in your experience with RTX, the cases of PML were cancer patients who were receiving other cytotoxic drugs at the same time (versus autoimmune patients who were only receiving RTX)? Is this correct? If so, it matches with what my doctor and the nurses at my infusion center (which is a cancer center but I get IVIG there) are saying. And I like your comparison b/c I am allergic to aspirin, and it would for sure be dangerous if I took it, vs. RTX (if I am not allergic) could be okay.

ETA: The test I am going to do is called "Stratify JCV Antibody" (blood test). I know it does not predict someone's risk for PML vs. just past exposure to the JC virus. Do you have any thoughts about or familiarity with this test? Thank you in advance!

As far as I am aware JC virus is thought to be commonly present but almost never causes PML unless there is immune suppression. I had assumed that any of us may have it or come across it. It is extremely rare for people given rituximab who do not have any other reason for immunosuppression to get PML but there are a few cases. It would worry me a bit if your infusion centre is not aware of the figures on this. If they use rituximab they should be. But the risk is certainly very low. The risk of pneumonitis is much more significant. I have seen it in several cases.

 

[Jesse2233]

As far as I am aware JC virus is thought to be commonly present but almost never causes PML unless there is immune suppression. I had assumed that any of us may have it or come across it. It is extremely rare for people given rituximab who do not have any other reason for immunosuppression to get PML but there are a few cases. It would worry me a bit if your infusion centre is not aware of the figures on this. If they use rituximab they should be. But the risk is certainly very low. The risk of pneumonitis is much more significant. I have seen it in several cases.

Is it possible professor that taking Rituximab alongside another drug that affects the immune system but isn't classified as an immunosuppressant (I will not use the term immunomodulator ) might activate JCV or cause other complications?

 

[Gingergrrl]

As far as I am aware JC virus is thought to be commonly present but almost never causes PML unless there is immune suppression.

Thank you and this matches what I am being told/reading. Do you have any opinion of the "Stratify JCV" blood test (done prior to starting RTX)?

It would worry me a bit if your infusion centre is not aware of the figures on this. If they use rituximab they should be.

Sorry, I was not clear at all. I am certain that my infusion center is aware of the figures and they administer RTX frequently to cancer patients. They carry out my IVIG order, as per my doctor, and I have gotten to know many of my nurses quite well so I casually asked them about RTX (in case I do it in the future) and they all told me that they had never once seen or heard of a case of PML from RTX. We really did not discuss it beyond that.

The risk of pneumonitis is much more significant. I have seen it in several cases.

Is there a certain type of patient of profile of someone who would be more at risk of developing pneumonitis from RTX (or is it random)?

 

[deleder2k]

I think that most patients who deteriorate after rituximab do so because they spend much energy on preparing, getting to hospital, staying in the hospital for 5-6 hours the first infusion, travelling home and so on. Someone also gets side effects from the glucocorticoids given prior to the rituximab infusion. Even though we don't know yet, there seems to be some patients that react to the drug itself. We don't know why, but the side effects doesn't seem extremely significant for the majority of patients. If one is bedridden I wouldn't gamble with rituximab, but if you're able to fly to Norway and walk around without getting much worse, I would consider it if I had the $ to do so. One could also argue that we'll know the answers to the phase 3 trial in just one short year, and that the best thing would be to wait.

It seems to me that it is difficult to compare the effectiveness of Ampligen to Rituximab. I have not heard of patients recovering compeltely after getting Ampligen. The fact that they give two Ampligen infusions a week seems like something that would have a significantly bad effect on many patients. And how we figured out what the cost is? If the price is 5 times rituximab treatment for a year, is it worth it?

Another question is if someone actually will give you Ampligen. You could send an e-mail or call Kolibri Medical and ask them about it. Tell them about the studies and that it is available through the Early Access Programme. I think one of the reasoning behind Kolibri treating patients with rituximab is that the doctor has used the drug for many years, and knows how to handle it. I have no clue whether he would be willing to prescribe Ampligen.

 

[Gingergrrl]

I think that most patients who deteriorate after rituximab do so because they spend much energy on preparing, getting to hospital, staying in the hospital for 5-6 hours the first infusion, travelling home and so on.

I know this would not be the case for me b/c I travel back and forth to hospital infusion center three days in a row every 3-4 wks for IVIG and do a 7-8 hour infusion each day. So, if I have a reaction to RTX, in my case, I will know that it is from the RTX itself. (Granted however when I say "travel" it is as a passenger by car and not flying on a plane to Norway)!

Someone also gets side effects from the glucocorticoids given prior to the rituximab infusion.

I do agree with this and when I had a high dose of Decadron w/IVIG as a headache preventative I had absolutely horrible side effects and never used it again. I may try it in the future at a very tiny, micro dose but am hesitant even to do this. With RTX, however, I would do the steroid.

If one is bedridden I wouldn't gamble with rituximab, but if you're able to fly to Norway and walk around without getting much worse

For whatever reason, I view it the exact opposite which is so interesting. If I were completely bedridden (which I am not) then I would feel that I absolutely had nothing to lose and would risk death to try RTX. Vs. if I were well enough to fly on a plane and walk around (which I am nowhere even close) then I would not take the risk. My end-goal is to be able to fly on a plane and walk around.

It seems to me that it is difficult to compare the effectiveness of Ampligen to Rituximab

I have to agree although truthfully I do not understand the mechanism of how Ampligen works vs. RTX is for B-Cell depletion to stop auto-antibodies at the production level.

And how we figured out what the cost is? If the price is 5 times rituximab treatment for a year, is it worth it?

I also think with RTX, there is a chance (even if small) that insurance will pay for part of the cost whereas with Ampligen there is zero chance b/c it is not an FDA approved med.