Documents from the SMILE trial

Aren't they also told to not reveal 'secrets' about the Lightning process itself, else it won't work? I think I heard that somewhere? But someone would have to double check.

 

I wouldn't go that far by any means, but I think there might be some common elements. One possibility being isolation of 'victims' away from people who might otherwise provide sanity checks on what was happening to them.

 

James Coyne commented on this last Sept ...

https://jcoynester.wordpress.com/20...nal-providers-in-esther-crawleys-smile-trial/

But note this does not itself clarify/confirm if the LP given to children does apply such secret-harbouring principles. Would be good to know one way or the other. But crucial to not go off half-cocked until we do.

 

Well put. They're certainly not equivalent things, but the similarity in patterns worries me. @Trish 's query is important to check. If kids were required to lie/keep secrets, that is an exploitative dynamic.

The same worries apply to adult subjects as well, but the calculations with regard to consent are different.

 

My guess is that the trial will ultimately be withdraw because of the technical methodological shenanigans. These were serious violations and would or should doom any study. I think that will make it easier to get traction on the serious and very legitimate questions raised about the LP itself and whether it was ethical to ever allow this trial to happen. My choice to focus on the methodology was pragmatic--not because I wasn't concerned about the ethics of the LP itself. It was easy to make a clear-cut and irrefutable argument against what the investigators did from the perspective of basic scientific principles--like not changing your outcomes based on early results, and then not telling anyone about it.

 

That's part of my problem with it. Who knows the content, and what vetting of it was done by someone with the expertise to spot the potential problems?

As we are not allowed to know, I feel there should be some professional assessment of the potential for harm. I'd be interested in hearing some advice from Jane Colby, if someone would contact her on social media? Who has the authority to audit the content of it in this specific instance, and who in general?

 

Also, thinking further, how do we know that the Lighting Process in the SMILE trial is the same as the one given to children in other instances, even if it was modified in this instance? It's not even a problem with children with ME/CFS, it's potentially a problem for all children who go through it. What a mess.

 

I'm not sure how many people are particularly deeply committed to basic scientific principles (half tongue-in-cheek, half serious).