BBC: Research in Norwich could offer ME/CFS breakthrough

[Invisible Woman]

I love that Prof Carding pointed out that this research has been almost entirely funded by patients themselves.

So at odds with the BPS narrative of false illness beliefs and the condition being maintained by secondary advantages such as benefits.

These are the very patients who are donating what little they have to research because they want to get better.

 

[Sidereal]

Very smart guy.

 

[A.B.]

So at odds with the BPS narrative of false illness beliefs and the condition being maintained by secondary advantages such as benefits.

Bad science is maintained by secondary gain.

Very smart guy.

Do you think he's right that ultimately this disease may be triggered by some process in the gut?

 

[Sidereal]

Do you think he's right that ultimately this disease may be triggered by some process in the gut?

Yes.

 

[Jo Best]

I love that Prof Carding pointed out that this research has been almost entirely funded by patients themselves.

So at odds with the BPS narrative of false illness beliefs and the condition being maintained by secondary advantages such as benefits.

These are the very patients who are donating what little they have to research because they want to get better.

Your post prompted me to look up the March 2014 article by IFR about the founation study and how that was crowdfunded and it was a nice surprise to see their recent posts about the research on their Facebook and Twitter feeds on the right hand side of the page - http://news.ifr.ac.uk/2014/03/crowdsourcing-me-research/

 

[deleder2k]

@deleder2k Thank you so much ! When you say 200 patients, do you know if they are all ME patients ? Is their protocol specifically for ME ?

Not sure if you've seen this. It is a news clip from the clinic

 

[MEMum]

Have just looked on IFR FB page and tonight at 7.30 on ITV 'Save Money: Good Health' IFR say
Lindsay Hall and her team explain how probiotics might work.
Presumably Lindsay is part of their team...

 

[cirrus]

Have just looked on IFR FB page and tonight at 7.30 on ITV 'Save Money: Good Health' IFR say
Lindsay Hall and her team explain how probiotics might work.
Presumably Lindsay is part of their team...

Scientists at the Institute of Food Research (IFR) have uncovered a new mechanism linking bacteria in the gut to Inflammatory Bowel Disease (IBD)
http://www.ifr.ac.uk/news/latest-ne...t-microbes-affect-inflammatory-bowel-disease/

 

[bertiedog]

Scientists at the Institute of Food Research (IFR) have uncovered a new mechanism linking bacteria in the gut to Inflammatory Bowel Disease (IBD)
http://www.ifr.ac.uk/news/latest-ne...t-microbes-affect-inflammatory-bowel-disease/

This is the sort of study that confirms what integrative doctors have been saying for many years. They would go further and say that by eating foods containing gluten we can end up with autoimmune issues as the proteins get through the gut lining which has now become permeable and cause all sorts of problems with the immune system attacking not only the gluten protein but also certain essential glands like the thyroid setting up autoimmune thyroiditis through the process of molecular mimicry.

Pam,

 

[JamBob]

@veganmua, if you're willing to move from the Great city of London to engage in a trial where there is a 50% you'll receive placebo, perhaps you would be interested in getting treatment in Norway? 2 infusions + 4 maintenance infusions is around £16,500. The hospital is located outside of Stavanger, and you can fly from Gatwick or Heathrow non-stop. The flight time is around 1h 45m.

@deleder2k
Just wondering - what time period would 2 infusions + 4 maintenance infusions cover? Is that one year's treatment or less than one year? And how long would you need to live in Norway during and after an infusion?

Also would you need to pay £16,500 a year to stay in remission? (Just wondering how much I'd have to save up to get that kind of help). Thanks

 

[deleder2k]

You get infusions according to the trial: https://clinicaltrials.gov/ct2/show/NCT02229942 I would also advise you to read the studies that is published in PLOSone.

You need to be at the clinic for 1 hour after the infusion is done. Then you can fly home to Great Britain.

 

[JamBob]

Great - thanks for the links - it seem that remission could last a varied period of months depending on the patient. I will start saving!!

 

[Dechi]

@JamBob I wrote to them, here is the letter I received a few days ago :

***************

Treatment with RituxiMab


Who receives the treatment with RituxiMab for ME?

The diagnosis should be informed at a public hospital or with a specialist. There should not be other diseases that can preclude the RituxiMab treatment.


The treatment is based on studies of RituxiMab for ME performed at Haukeland University, hospital in Bergen. The treatment contains two courses of RituxiMab which are given two weeks apart. It is followed by maintenance treatment after 3, 6, 9, 12 and 15 months.


Wewill havea consultation with a clinical examination and blood test at Kolibri Medical before the treatment can start. If necessary there will also be performed a lumbar puncture. You must bring a copy of your medical records to the consultation. The treatment is not approved by public reimbursement and is experimental. The patient will be informed of the result about 2 weeks after the first examination is completed. You must pay the treatment yourself.


About RituxiMab: RituxiMab is a immune substance that have been used for treatment ofrheumatoid arthritis for over 30 years.


Side effects about RituxiMab: It is over long time documented safety and side effects for RituxiMab. You can find more about it if you visitwww.felleskatalogen.no. It is described some serious side effects and even casualties using this medication. Serious side effects are rare and are described in severely ill arthritis patients. RituxiMab has not been used long enough in ME-patients that we have been registered a complete side effect profile.


Oueexperience is that 75% will experience light reactions as itching, rash, tightness in throat, headache or fever during initial treatment. Side effects disappear when the infusion rate is reduced. Allergic reactions are rare in subsequent treatments. After treatment 25% will notice a transient worsening of symptoms of ME. These usually disappear after 1-2 weeks. You must avoid infections the first weeks after treatment. If you notice any symptoms beyond this, please contact your prime doctor or Kolibri Medical tlf: 52696969.


Before the infusion starts you have to sign a consent form.


Prescription on RituxiMab is submitted electronically and can be retrieved at any pharmacy. The medicine should be kept out of light, it must be well packed and can't be stored at room temperature for more than 8 hours. It is recommended that the medicine is picked up at a local pharmacy the same day or the day before infusion.


It is recommended that you bring a companion to the first treatment.


It is not uncommon with light side effects due to the treatment with the medication. You are continually monitored by a nurse and the doctor is available during the entire treatment. The treatment rarely cause serious side effects. You will be informed of this during the consultation and during treatment. We recommend close contact with your GP or another doctor before and after the treatment to ensure a good follow-up. If it occurs complications you can contact Kolibri Medical.


Prices:

- The first consultation with a specialist cost 5000 NOK. In addition you have to take blood samples necessary for eventual follow-up examinations.

- The first treatment with RituxiMab costs 8000 NOK for the infusion. Follow-up with the doctor costs2300 NOK and the RituxiMab costs approximately25000 NOK.

- The second treatment with RituxiMab is the same price.

- Further maintenance treatment with RituxiMab costs 5000 NOK for the infusion, follow-up with the doctor costs 2300 NOK and the RituxiMab costs approximately 12 500 NOK.




Kolibri Medical November 2015

 

[Ben H]

I love that Prof Carding pointed out that this research has been almost entirely funded by patients themselves.

So at odds with the BPS narrative of false illness beliefs and the condition being maintained by secondary advantages such as benefits.

These are the very patients who are donating what little they have to research because they want to get better.

Great point- the fact that many are spending their disability allowance on funding research. Like you say completely at odds with the BPS brigade narrative.

Insane situation, but also beautiful and inspiring too. Each time someone donates to OMF for example, the entire team is so so grateful as they know many have very little funds. It is very heartwarming indeed.


B

 

[nikefourstar]

Didn't this treatment make Whitney worse? As disabled as I am I will wait for dr Davis to come out with his bio marker and treatment. I don't trust this crap

 

[AndyPR]

Bit confused about the clinic currently offering Rxmb treatment;
from Fluges presentation I seem to remember him saying that there was only one infusion, then it was a couple of months or so before the ME patient went into remission, and that this only lasted for 3 months. So are these patients having infusions every three months ad infinitum?

From https://clinicaltrials.gov/ct2/show/NCT02229942 (Stage 3 trial, stage 2 used same dosing schedule)

Rituximab induction (two infusions two weeks apart) and maintenance (infusions at 3, 6, 9 and 12 months)

 

[Murph]

Not sure if you've seen this. It is a news clip from the clinic

Wow, that's pretty amazing and exciting that the Sandnes clinic treating patients, even before the Phase III trial is done. I'd like to see their data.

Even though it won't add to the formal body of evidence, it will add more to the generic body of knowledge about the use of Rituximab. My initial reaction is to be pleased they're offering it, but I really hope there aren't bad side effects that could make authorities crack down...

20,000 NOK [edit: i mean 200,000NOK] is about $A32,000. Not cheap. Especially for an Australian considering travel costs. Out of reach, really, for me. I shall wait and see.

 

[Snow Leopard]

20,000 NOK is about $A32,000. Not cheap. Especially for an Australian considering travel costs. Out of reach, really, for me. I shall wait and see.

Me too, I simply cannot afford it.

If the phase 3 trial demonstrates efficacy there is still going to be a shitstorm debate before it is both approved and able to be funded by insurance (USA) or the PBS...

 

[AndyPR]

"Induction with two infusions two weeks apart, rituximab 500 mg/m2 (max 1000 mg).

Maintenance with rituximab infusions (500 mg fixed dose) at 3, 6, 9 and 12 months."

exactly.........then what? (the guy having the treatment had only had CFS for a year(?)). I think they are jumping the gun a bit.
IMO the best thing about the Rtxmb trials are what they are showing up in terms of how the illness 'works';
a 'cure' would be nice but constant infusions(?)

I'm not sure I follow your understanding of how rituximab is used and tested.

Stage 3 has 150 participants (not clear if 150 patients, so best to say 75 patients receiving Rituximab and 75 controls), and the stage 2 had 29 patient participants.

Results of the stage 2 can be seen here http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0129898#sec016, they report 14 (out of 29) patients as being major responders, 4 patients as being moderate responders.

Among 14 patients with major response, at end of study (36 months follow-up, last patient in February 2014) nine were still in ongoing, stable clinical responses (Table 1, Fig 3, S4 Fig panels A-G, S5 Fig panels M,N). At end of follow-up, four patients had experienced different levels of relapse (Table 1, S4 Fig panels H,I,K,L). In addition, one patient was diagnosed with a T2N0 breast cancer at 24 months follow-up. At that time she had slight symptom worsening but not a clear relapse of ME/CFS, subsequent to a response period following ofatumumab infusions (Table 1, S4 Fig panel J).

Table 1); one when he chose to withdraw from study after 25 months (S5 Fig panel P) and one at the end of follow-up at 36 months (S5 Fig panel R). Two patients with moderate response experienced some symptom worsening before end of study. One of these chose to withdraw from the study after 32 months, however the worsening was transient and she remained in moderate response after end of follow-up (Table 1, S5 Fig panel Q). In one a partial relapse occurred from 32 months (Table 1, S5 Fig panel O).

Of the two pilot patients, one experienced a full relapse at approximately 30 months, 11 months after the last rituximab infusion (Table 1, S4 Fig panel L). One pilot patient is still in complete response with no ME/CFS symptoms even after vigorous exercise, five years after the first, and 3 ½ years after the last rituximab infusion (Table 1, S4 Fig panel A).

My bolding.

So there is nothing else after the 12 month dose, that's it, it either works or it doesn't.
Jumping the gun? If you mean patients getting Rituximab treatment privately before stage 3 results are released then I agree but some people obviously are willing to gamble on a 65% improvement rate from the stage 2 trial. If you mean Fluge and Mella, they are following up the promising results from their stage 2 study that followed patients for 36 months with a much larger stage 3 to test it's efficacy.
Constant infusions don't happen and, so far, it is not a cure for the vast majority of people treated.

 

[nikefourstar]

They are evil drug company's, even if they had a cure they wouldn't sell it. Because then after everyone is cured there is no money left to be made. The best chance we have to a cure is Ron Davis... bless that beautiful man and his family @Rose49