Dr’s Fluge and Mella had produced a breakthrough and they had a new problem. Over 60% of the ME/CFS patients they gave the powerful immune drug Rituximab significantly improved but they tended to relapse when they were off the drug. Plus some patients didn’t react to the drug.
Rituximab is having an effect. The only question that remains is on how many…
In this study the two Norwegian doctors a) tested the drug on more patients, b) tried to make the improvements permanent and c) have more patients repond.
Rituximab is the hottest treatment possibility out there. Check out how it did in it’s second major trial and see what’s next in the Rituximab/ME/CFS saga in the Simmaron Research Foundation sponsored blog
Thanks again, Cort, for the updates. Hats off to the Norwegians for following up on this discovery with trial studies. Seems like we should have good hope that the next phase will hold promise. Can we have also have hope that others in the medical research field will want to take the clue of B cell dysfunction and further explore the more precise mechanism of failure? And of course the needed therapy to correct it.
It’s my hope that other researchers aren’t so locked into their own bubble of work that nothing else will be looked at regarding this discovery for the next 5 or so years until this latest trial is wrapped up.
Can the N.I.H. still defend their paltry allocation of CFS research $ after these kind of results?
I hope they can’t!
Thanks, Cort. Your comments on the US situation are particularly interesting.
I wonder if US advocates should be pushing for a US multi-centre rituximab trial?
We’re going to need several trials to provide enough confidence to regulatory bodies to approve rituximab in our various countries and it’s not clear that it makes any sense to wait for the end of the Norwegian trial, and then add several years onto the wait for patients to get the drug. Two trials in Norway (30 patients and 152 patients) are unlikely to be enough. Dr Charles Shepherd of the UK MEA (who has ME himself) is pushing for a multi-centre trial to start in the UK now.
Glad to hear it about Dr. Shepherd. Yes, I think advocates should be pushing for a large multi-centre trial and a lot of other things. 🙂
As mentioned here above earlier this is a great discovery of a treatment for a grop very ill people, of course.
But I wonder, when it takes 10 years from discovery, to “end trail” and out in the hands of the sick people, how can it almost tak another 10, when the medication have soon been out there for 20 years with know risks.
With these results… it’s just don’t make sense to me. I am sorry.
..and from 2009, now soon we enter 2016. ..and another two years? The patent is there. Then what can be the problem? The biomarkers? …or what?
As I of course now, it is reasearch on humans, but how is it possible. I just ask myself. Is it all about the money?
I wish everyday, that this discovery was made in 1920, a time when we used common sense with it came to medicine for the benefit of the people.
I think there are still reasearch on HIV allthough they allready have medications working well.
Now Hep. C is curable. How long did they have to wait? It was just a drug combo. This is not even a drug combo…
Their theory around vessels is very interesting.
The UK’s ‘Invest In ME’ Rituximab trials will be running in London – I’m going to do my best to get on it, when it finally starts recruiting!
My family have all sorts of auto-immune issues, one way or another, and 3 (perhaps 4) of us have ME/CFS, so I’m not surprised to hear that this is showing signs of success. I remember telling my GP that I actually felt better when I was ‘properly’ ill with a cold or whatever. Perhaps my B cells found some real work to do for a time.
in the meantime, I’ll be doing some NLP work to see if I can persuade my immune system that it can relax…
Good luck Penelope!
While there is certainly promise, the cost right now makes it essentially unavailable to those who need it. The ‘list price’ of each infusion is just shy of $30K. The protocol calls for two infusions 30 days apart followed by another two infusions in 6 months. That’s $120K. Even after insurance the patient will likely have to pay around $5K out of pocket. And it may have negligible results. Trials should continue by all means but this kind of money is a non-starter to people who are likely disabled to start with (IMHO of course).
So expensive!
I looked up news on generic versions of RItuximab. It’s not particularly good..
There is hope for a generic but there are some barriers standing the way. It will take some time…
http://leukemia.emedtv.com/rituxan/generic-rituxan.html
Because Rituxan (rituximab) is considered a “biologic” medication, it is subject to rules and laws that prevent any generic versions from being manufactured.
However, these laws will probably be changed to allow for generic biologics to be made. When these rules change, patents could still protect Rituxan from generic competition, so it’s hard to say when a generic form of the drug could become available.
It belongs to a group of drugs known as monoclonal antibodies, hence the “mab” (an acronym for “monoclonal antibody”) at the end of the name “rituximab.” This drug is administered intravenously (by IV).
Rituxan is manufactured by Genentech, Inc. Technically, it is considered a “biologic,” and is therefore under different rules and laws than most other medications.
When Will Generic Rituxan Be Available?
Although new laws have cleared a path for the possibility of generic biologics, there is still quite a bit of rulemaking to be done. However, even once all the official business of allowing generic biologics is completed, it is likely that Rituxan will still be protected from generic competition by patents. It is not exactly clear when the patents expire, as the United States Food and Drug Administration (FDA) does not yet list applicable patents for biologics, as it does for other medications.
Is Rituximab a Generic Rituxan?
No — rituximab is the active ingredient in Rituxan, but is not a generic version of it. What can be confusing is that oftentimes, the active ingredient of a drug is referred to as the “generic name.”
The generic name is different from a generic version of a medicine. In order for there to be a generic version, the original medicine must have gone off-patent and another company besides the original manufacturer must make the product.
Except I looked further and there’s some good news! A Rituximab generic is being eagerly pursued by a number of big pharmaceutical companies. The European patent expired in 2013 and expires in the US in 2018.
Check out more here – http://www.cortjohnson.org/forums/threads/generic-rituximab-possible-but-a-ways-off.2753/
I will also say that there are a handful of financial aid programs out there backed by Genentech and others. It all depends on if you are insured, are on medicaid and exactly what condition you have. If you think it might help you, it’s worth checking the Genentech site. http://www.genentech-access.com/patients
Good point Jim. Needymeds has a list of drugs one can get help with…
Can one go to Norway to get the infusions & is it as expensive?
Can one go to Norway to get the infusions & is it as expensive there? How about Canada?
No idea Lynne. My experience (actually my wife’s) is limited to what we’ve been able to find in Atlanta. I certainly would caution against spending any amount of travel money just to save Rx money unless you absolutely know for certain it will significantly improve your well-being. She monitored things daily and looking back at the data, I can make a case that she saw a slight improvement over a 5 month period but I can also make a case it had no impact. Bottom line for her was that it wasn’t an “OMG” type of relief. She’s found much better results using LDN.
I sure hope they can figure out who is most likely to respond…
Thanks Jim! I had not heard of LDN, but just did some research.
I will approach my rheumatologist about it. Thank you again!
Lynne,
Don’t be surprised if your Rheumy has never heard of it or thinks it’s an opiod or plain poo-pooh’s it. It’s a generic that you have to get from a compounding pharmacy so the major frame co. don’t push it (and that’s where doctors get 98% of their “drug” knowledge). I can point you to some resources that may help but I don’t want to cross a line Cort doesn’t want crossed.
Jim: Thank you for all your helpful information and for caring. I will print out some studies & info on LDN and send it into him before my appt. He’s good about reading what I give him–not
a cookie cutter dr. You’ve been so helpful, I can’t thank you enough!! How limited is your wife & much improvement did the LDN give her?
Lynne
Hi Lynne,
LDN made a huge difference to my wife. Gave her back her life. That said, it’s not a cure and it’s not magic. She doesn’t have to take pain meds at all and it has lessened the fatigue (seems to have a greater impact on pain than fatigue).
The main thing to understand is that there is no one size fits all and figuring out your dosing is largely trial and error. There’s no danger as you can’t OD on LDN but you do need some patience while it starts to do it’s thing and then listen to your body (and others who have experience) to make adjustments in dosing as you go forward.
Jim
Definitely go for it. It’s helped a lot of people and it’s pretty cheap. If your rheumy doesn’t go for it go to LDN research trust and find a doctor who will prescribe it.
Good luck!