Teclistamab for ME/CFS

[Utsikt]

Data is Not entirly useless.

For all intents and purposes it is, as JE explained above. And the minuscule value it might produce doesn’t outweigh the risk of harm by any reasonable standards.

You do not know the individual cost functions of people, I think its unreasonable to assume that Out of all patients, there are Not some for whom It makes sense.

I severely doubt the patients are given sufficient information to give proper consent.

Regardless of that, it simply isn’t ethical to do medical experiments on people just because they are willing to say yes to it, if the experiments doesn’t produce any meaningful information. This has nothing to do with what any one individual patient wants or not, it’s about the ethical, moral and legal duty of HCPs to do no harm.

Yes, not here, but Its still making quite a wave right ?

I can’t answer for anyone else, other than giving you my impression of the sentiment in the Dara threads. Besides, if uninformed people are gazing over something has no bearing on the merit of doing that or similar things, so I don’t understand its relevance to this discussion.

Scheibenbogen hypothized this,
(…) Its insane to introduce so much uncertanty in the results just because you do not get funding for the same Dosis as in the Phase 1 Trial.

It doesn’t look like this holds up under scrutiny (from this thread):

I heard people suggest that the dosage might be different (and that the Norwegian trial couldn't provide the dosage because of lack of funding). Not sure if this is true. Here's what I could find online:

Fluge et al. 2011 (pilot RCT, n=30)
Rituximab 500 mg/m2 given twice two weeks apart, with follow-up for 12 months

Fluge et al. 2015 (phase-2, open-label, n= 29)
2 infusions (500 mg/m2) 2 weeks apart, followed by maintenance rituximab infusions after 3, 6, 10 and 15 months

Fluge et al. 2019 (phase-3, RCT, n = 152)
2 infusions of rituximab (500 mg/m2 of body surface area), 2 weeks apart
followed by 4 maintenance infusions with a fixed dose of 500 mg at 3, 6, 9, and 12 months

Japanese trial (RCT, crossover, n = 30)
four times at weekly intervals during the first three weeks of the primary and secondary evaluation periods.
(375 mg/m^2/week iv. x 4 times)

Not sure if this is a significant difference.

 

[Jonathan Edwards]

but we do Not need to be "päpstlicher als der Papst".

Nicht nötig, ich bin der Papst.

 

[someUsername]

For all intents and purposes it is, as JE explained above. And the minuscule value it might produce doesn’t outweigh the risk of harm by any reasonable standards.

You would be SOOO unhappy about the Treatment protocol that I am pushing my doctor to do

To get Back to topic,
I do not understand the point about the Data Not being valuable?
Afaik Habets will publish the "results" of the first 10 cases soon. And I think It is safe to assume that he will Not conciously doctor those.
Ofc a rct would be better, but why should this data be meaningless ?

 

[Utsikt]

To get Back to topic,
I do not understand the point about the Data Not being valuable?

JE has already explained that here:

Post in thread 'Teclistamab for ME/CFS'

Yesterday at 2:03 PM

Could you elaborate? As far as I know, I don't know what data they have nor what diagnostics, inclusion criteria etc they use. If done properly, why would it not generate useful data? Genuinely curious.

The first thing you want to know is improvement in the condition but for ME/CFS the measures are so subjective and placebo and relate issues so big that you are not going to get any direct data. There are not going to be any indirect or surrogate data because there are no abnormalities like raised CRP that we know to be surrogates. There are no known relevant autoantibodies so they...

• Jonathan Edwards

• 

It’s not about data being doctored, I have no reason to assume bad faith, but that we have no good measurements for «improvements» in ME/CFS so it’s difficult to track. And we know that saline can be followed by what appears to be substantial improvements, even in quite rigorous trials by Fluge and Mella. Without doing blinded RCT with placebo, you have no way of knowing if you’re actually achieved anything with the drug. But you get all the risk of using the drug.

 

[Jonathan Edwards]

I do not understand the point about the Data Not being valuable?

As Richard Feynman said (to quote Google AI):

"The first principle is that you must not fool yourself—and you are the easiest person to fool," emphasizes the importance of self-honesty and critical self-reflection, especially when pursuing knowledge or attempting to understand the world. It highlights the tendency for individuals to unconsciously distort information or hold biased beliefs that align with their desires, making them their own worst enemy in the pursuit of truth.

Science is 90% that. A few make it through to the 10%.
And it is also pretty easy to fool other people, especially now we have social media.

 

[someUsername]

It’s not about data being doctored, I have no reason to assume bad faith, but that we have no good measurements for «improvements» in ME/CFS so it’s difficult to track. And we know that saline can be followed by what appears to be substantial improvements, even in quite rigorous trials by Fluge and Mella. Without doing blinded RCT with placebo, you have no way of knowing if you’re actually achieved anything with the drug. But you get all the risk of using the drug.

These seem to me like reasons why the Data needs a certain Prior to be understood in context, but Not at all a reason to completly disregard it.
I do think that this will be an indication If further Investigation ist warented.

Maybe this is the first step to having the results of a tecil Phase 3 rct in approx 7 yrs.

 

[Utsikt]

These seem to me like reasons why the Data needs a certain Prior to be understood in context, but Not at all a reason to completly disregard it.

If the data is exposed to substantial sources of bias, it can in most cases be completely disregarded. That’s why we need to do trials properly.

And due to the risk of the interventions, we need a good rationale for even doing a trial, and alternative methods of testing the hypotheses should always be considered.

I think we’re going in circles here.