Lightning Process study in Norway - Given Ethics Approval February 2022

The research director at the Norwegian Institute of Public Health - Signe Flottorp from the Dagbladet article on twitter

https://twitter.com/user/status/1261713001163501568

 

https://twitter.com/user/status/1261967067206516736

 

Exactly.. And As Tuller found out Wyller just did a PACE by changing the primary outcome (steps), when there was no effect on it. He will do it again im sure

 

And that newspaper article cites the Bristol creepy one's research into LP too, to try prove it's a good idea to do this research.

 

https://twitter.com/user/status/1261718899541913601

 

Dr Flottorp misses the point that we need DBRCTs or cast iron objective endpoints.
The rituximab study was a DBRCT.
'The RCT' of LP had a null result.
Sometimes I wish I was on twitter but most of the time I do not.

Perhaps someone should tell the lady that the man who got rituximab for autoimmunity started with a DBRCT does not think that the trials of LP bear any relation to trials of rituximab.

 

If that is the case, more than placebo, LP is getting at root cause of ME according to Flottorp. Am I right? And it’s happening almost instant, with long lasting and quite dramatic effect. So what exactly does that mean then? That the cause of ME is fear/avoidance/unhelpful wrong thought pattern for whatever reason. So ME is solved, then? Well, I don’t accept that explanation on a group level. And that is often what these people tell. So much of dialogue could be better if they nuanced and moderated they’re claims.

What about all people who have done LP and experienced the harmful sides of it? Where does these patients fit in in that model?

 

I'm wondering about Flottorp's response in a tweet posted above where she states that several people with ME long term have been helped by LP.

Two problems I see are what exactly does 'helped' mean. Helped is not recovery. And is she following those people long term. ME is a chronic condition. Long term follow-up is necessary to know that the treatment is effective especially as symptoms can fluctuate.

 

They fit into the model as people who didn't do it right.

 

With regard to the same tweet -

If the GP has recommended LP and a patient struggles with it, is told by their LP practitioner that they are responsible for their own lack of progress or deteriorating, how likely is it the patient will feedback the problems with the GP? Aren't they more likely to assume the GP will also tell them it's their own fault?

It's fairly staggering that a GP can't see the potential to trigger mental health problems in vulnerable patients who deteriorate after LP.

 

In my opinion the potential for harm to patients is large.

Patients are typically financially dependent and often rely on family members. This relationship relies on trust because it's not possible to prove that someone is as disabled as they say they are.

It is very toxic to suggest that patients are doing the illness and could snap out of it in three days. On these forums you don't hear often about cases where patients are disbelieved by their own family but it does happen and it's very bad. There is the potential to make these kinds of situations horribly worse. I think it's not an exaggeration to say the consequence of zealous promotion of claims that LP cures ME and is now backed up by science could include suicide and deprivation of care.

This could make it harder to advance actually useful research.

There's also potential for harm by the therapy setting goals that are impossible to meet.

 

Yes, I wasn't clear. Any follow-up needs to be measured in years. I expect that would be impossible for any BPS person to understand the need to do that.

 

But not on a randomized sample. Not everyone is susceptible to this kind of manipulation, even discounting the fact that they select for the mildest patients and, mostly, not even ME patients. You have to pledge belief in the treatment, this is a required selection process for LP. This cannot be randomized and so it won't. They will pretend it is randomized because allocation will be randomized after the selection process but obviously that's nonsense. This is baked-in the LP so it can't be avoided and neither is the pledge of silence, for which ethical approval is beyond absurd.

Which disqualifies even trying to make a formal trial, which this isn't at all. It's a biased financially-conflicted experiment that makes no pretense of being legitimate.

I'd actually be OK with a legitimate trial run by an independent group making objective assessments. Nothing this ridiculous can withstand formal scrutiny so an actual formal clinical trial would be just as much a formality as whatever this is here, the outcome would be entirely predictable. And it's not even subtle with having newspapers run PR while the alternative medicine industry is basically saying "yeah, this is too much woo for us you really should chill it here" to the medical authorities.

It's a sign that so much downright fraudulent practices have been normalized in BPS research that multiple individual fatal flaws are essentially barely noticed. There are dozens of major flaws that by themselves make the entire effort disqualifying and they are skipped over because past fraud has normalized future fraud. This is the destruction of the formal practice of clinical research. At this point let's just go back to shamans if that's how medical authorities behave.

 

Why is this newspaper blatantly doing PR here? Really weird and hard to justify.

 

Religious-like conviction. "I've seen anecdotes" + misrepresenting a methodologically-flawed experiment that is obviously not a proper RCT and actually showed the opposite of what she argues. Also a few positive anecdotes of dubious applicability somehow far outweigh thousands and thousands of formal negative testimonies. Absurd.

I must point out once more that this person's apparent topic of expertise is reliability of evidence. I'm sorry but this is simply not acceptable. This level of mediocrity is simply incompatible with a rigorous profession that deals with matters of life and death. The cult of psychosomatics is completely out of control and seems to be frying people's brains whole.

 

I know several people who have been more re less bullied by family members wanting them to do this. The old " if you really wanted to get better.... "

Some expected to fund it themselves out of the tiny amounts of money they have adding even more money worries - not an inconsiderable harm in itself if they don't miraculously recover enough to suddenly earn an income.

Other's had offers of money from family. They're in a catch 22 - if they don't do it they're perceived as wilfully, actively trying to stay sick. Or they accept the financial help & if they don't recover not only are the family frustrated, they feel that the patient has wilfully squandered the money by but not making the most if it - because if they don't get better it's because they still insist on "doing" ME.

The thing is like a heavy goods vehicle without brakes or a horn- nothing but pressure to participate and complete abdication of duty when it comes to informed consent. Once underway, there is no mechanism to warn anyone it's off course and out of control. It is literally designed so you cannot have an open and honest conversation about any harms.

How can it be ethical or legal for a GP to suggest a course of treatment without giving enough information for informed consent and no means of reporting harm?

 

This is a really important point.

For a randomised trial patients should not undergo the usual screening process & if Flottorp had a clue she would realise that. The criteria for entry should be a recognised criteria for diagnosing ME- preferably one of the better ones. Then those patients randomised to the treatment group or the other group.

As it stands this is not an adequately controlled trial because the control group are simply on a waiting list & will be aware of that. This will bias any answers they give while they await their turn and confound follow up which is woefully inadequate anyway.

 

Good points.

Personally I find this blame game disgraceful. It is a classic case of adding insult to injury. In retrospect it is hard having to put up with the rationale behind LP that just don’t fit in at all. Then it is hard being told that you are to blame if it doesn’t work, also harms you. It is hard on the double, when knowing that before LP, you have actually done exactly what is required by medicine itself, lived up to Churchills standard of going through hell and kept on going, no less, also fulfilled the approach expected from society as well. You have done exactly what is expected and considered the right thing for a very long time and deteriorated. If you on top of that experience the relentless propaganda of a quick-fix, and it is only up to you, although you already have tried by actually doing/actions, well...? So here we are. And we can deal with that to. But it better be in silence, in thankful respect to these people that sacrifice so much in the name of pseudoscience.

 

https://twitter.com/user/status/1262130998684327942