Rituximab Phase III - Negative result

[Benji]

30 million kroner, which is 3 mill pounds.
Charity (Kavlifondet) donations and the Norwegian state.

 

[Benji]

 

[Benji]

Sorry for the big picture

 

[hinterland]

View attachment 25239

It doesn't surprise me that SW makes this comment. There have been other trials of monoclonal antibodies in medical conditions he considers to involve both physical and mental pathology, like schizophrenia and depression. He is on record as saying the research was probably warranted.

He knows which way the wind is blowing, and is a master at maneouvering himself into position on higher ground. It is also rather a good chess move, when it comes to his role as chief defender of the PACE trial.

 

[hinterland]

- Patients who, after disclosure of the study were found to have received a placebo, received them in the study, indicating that we would try to get a new study with rituximab if rituximab proved to have a safe effect. When this was not the case, we could not let the patient group get out of bed for months and wait for the study to be published, says Olav Mella to Aftenposten.

I'm sure something has gone awry with the translation here. I can guess what Olav Mella is meaning to say, but does anybody know how that part should read exactly?

"we could not let the patient group get out of bed for months and wait for the study to be published,"

 

[Benji]

I'm sure something has gone awry with the translation here. I can guess what Olav Mella is meaning to say, but does anybody know how that part should read exactly?

"we could not let the patient group get out of bed for months and wait for the study to be published,"

Get out of bed, hahahah. That’s a good one.
It was «gå i spenning», which means be waiting in excitement and uncertainty.

 

[fingers2022]

I'm pretty sure that this is what Dr. Davis and OMF are trying to do but the lack of money is limiting them to a very small sample size and stalling the research. I also suspect (and this is just my opinion) that without a bio-marker and having different sub-groups, it is incredibly challenging to know if all of the subjects in any given study actually all have the same disease.

'Small sample size' is kinda at odds with 'big data'
Your second point was exactly what I meant with 'Before treatments could be researched and tested, identification and diagnosis would need firm agreement.'
I think such an approach requires two main phases: 1) understand and define the problem, 2) solve the problem. Possibly with iteration of these two as more data is collected.

 

[fingers2022]

I am pretty sure I read somewhere that the trial cost around £30 million. I now can't find it - but it was some where in the last few days. Now I am wondering if this was krone or dollars but it was a high figure.

That'd be enough to fund a quality study on antiretroviral therapy. One hasn't been done, and many are experimenting with it. Rituxiab has had a shot, ART next folks.

 

[gregh286]

That'd be enough to fund a quality study on antiretroviral therapy. One hasn't been done, and many are experimenting with it. Rituxiab has had a shot, ART next folks.

Wouldnt be surprised if ART did well.
With such low NK numbers and activity between us bound to have high viral loading.
Would love to see an NK improvement trial.

 

[TreePerson]

That'd be enough to fund a quality study on antiretroviral therapy. One hasn't been done, and many are experimenting with it. Rituxiab has had a shot, ART next folks.

@Benji explained that it was kroner - so £3 million. Just in case you hadn't seen that.

 

[Wonkmonk]

Just heard the news. Bitter. But perhaps it's worth pointing out that an article in the New England Journal of Medicine found no effect for Valacyclovir in CFS/ME patients in 1988. Only later did Dr Lerner and Dr Montoya find a subgroup of patients actually do respond and that co-infections also play a role.

So as many others pointed out, the next question is to see if there is a subgroup of patients who respond to Rituximab. As @Gingergrrl pointed out, her reaction is likely no placebo and she probably isn't just one in 8 billion.

 

[ljimbo423]

I also suspect (and this is just my opinion) that without a bio-marker and having different sub-groups, it is incredibly challenging to know if all of the subjects in any given study actually all have the same disease.

That's a really good point. How many have other illnesses and how much does that skew the results? Until a bio-marker is found we can't even be sure of any single studies results.

One of the biggest reasons being that we can't be sure how many in the study actually had CFS. I do my best to put the results of all studies I read, in the context of all the others I have read and try to make some connections.

Jim

 

[fingers2022]

@Benji explained that it was kroner - so £3 million. Just in case you hadn't seen that.

Oh crumbs, we'd have to settle for a 3rd rate researcher then. Somebody like that charlatan Mikovits instead of a true professional like Lipkin

sorry, hate laughing at my own jokes but I've just creased myself up!!!!!!

 

[fingers2022]

Just heard the news. Bitter. But perhaps it's worth pointing out that an article in the New England Journal of Medicine found no effect for Valacyclovir in CFS/ME patients in 1988. Only later did Dr Lerner and Dr Montoya find a subgroup of patients actually do respond and that co-infections also play a role.

So as many others pointed out, the next question is to see if there is a subgroup of patients who respond to Rituximab. As @Gingergrrl pointed out, her reaction is likely no placebo and she probably isn't just one in 8 billion.

If we eventually do get to the point of clearly defining and diagnosing sub-groups, then logically we will have discovered different diseases which have common symptoms. I'm not expert in aetiology (yikes UK spelling shows as correct!), nor pathogenesis, but this would be logically correct...no?
As I type I am questioning myself...what about T1 vs T2 diabetes? Quite similar symptoms, different aetiology and pathogenesis. Different treatment, but with some overlaps, e.g. insulin, but this really isn't the way to go for type 2.

If we start with 'fatigue', then we will be all over the shop...I suggest not to start with fatigue.

Oh no, did it again

 

[Gingergrrl]

Just heard the news. Bitter. But perhaps it's worth pointing out that an article in the New England Journal of Medicine found no effect for Valacyclovir in CFS/ME patients in 1988. Only later did Dr Lerner and Dr Montoya find a subgroup of patients actually do respond and that co-infections also play a role.

I was wondering if you had heard the news yet @Wonkmonk and hoping you were doing okay and not too disappointed. Interesting comparison re: anti-virals and I knew there had been studies on ME/CFS patients with negative results but I also knew from Dr. Lerner's studies and anecdotally that they have helped many people (even though they did not help me).

So as many others pointed out, the next question is to see if there is a subgroup of patients who respond to Rituximab. As @Gingergrrl pointed out, her reaction is likely no placebo and she probably isn't just one in 8 billion.

I know there is a sub-group (or people who actually have a different illness) who are responders b/c they keep contacting me via PM even though very few are sharing publicly.

That's a really good point. How many have other illnesses and how much does that skew the results? Until a bio-marker is found we can't even be sure of any single studies results.

That was my feeling as well.

 

[Wonkmonk]

I was wondering if you had heard the news yet @Wonkmonk and hoping you were doing okay and not too disappointed.

I'm doing OK, I am lucky to have a treatment I respond to (Valacyclovir), at least to some degree. I think it's very disappointing for those who tried everything and nothing worked and Rituximab is the last best hope at the moment.

But I think we should not give up hope entirely. As someone pointed out before, the response pattern in prior Rituximab responders with CFS is similar to those with Rheumatoid arthritis. They get better and then worse again and then better again with the next Rituximab. Is this all a placebo effect? I think not.

CFS is probably not one disease, but perhaps 5-10 diseases with similar symptoms (Typ 1 vs 2 diabetes was cited earlier as an example). I think it's like with the Valacyclovir: Researchers have to better understand for which patients and under which circumstances Rituximab can be helpful. I certainly think not all hope is lost at this point.

 

[Gingergrrl]

I'm doing OK, I am lucky to have a treatment I respond to (Valacyclovir), at least to some degree.

I'm so glad you are doing okay, Wonkmonk, and that you are responding to the anti-viral.

But I think we should not give up hope entirely.

I totally agree.

CFS is probably not one disease, but perhaps 5-10 diseases with similar symptoms

I agree with this as well.

Researchers have to better understand for which patients and under which circumstances Rituximab can be helpful. I certainly think not all hope is lost at this point.

That is my hope, that the researchers will figure out the sub-group that does respond to Rituximab, and why they responded, and this will lead to additional research. I do not think that all is lost b/c they did not get the results that they were hoping for (and we still don't know what the final complete results will say).

 

[justy]

What language is he speaking? German?

He is speaking Flemish - from the Flanders region of Belgium. Its a variation of Dutch. KDM also speaksutch, French and English at a minimum, as do a lot of people in Belgium.

 

[pamojja]

He is speaking Flemish - from the Flanders region of Belgium. Its a variation of Dutch.

Interesting. As a German speaker myself I understood whole parts of sentences as if straight out of a German dialect. Therefore I too wondered. Thanks.

 

[andyguitar]

Probably Krone.