Norwegian Lightning Process Trial Ejects Questioning Participant

By David Tuller, DrPH

The administrators of a controversial study of the Lightning Process currently being conducted in Norway have ejected a participant who expressed critical views about the biopsychosocial approach to ME, according to MELivet [MELife], Nina Steinkopf’s invaluable blog. This decision appears to be an acknowledgement that the intervention only works if you believe it will work.

I have written extensively about the Lightning Process. The major pediatric clinical trial that claimed to prove this “mind-body” intervention was effective for ME/CFS was actually an egregious case of research misconduct and arguably fraudulent, in my view. The lead author of the trial was Bristol University’s methodologically and factually challenged grant magnet, Professor Esther Crawley, who has a habit of blatantly disseminating untruths in public presentations. So the fact that the trial was an ethical train wreck is not at all surprising.

As it turns out, Professor Crawley and her colleagues recruited more than half the study subjects before they actually registered the trial. They also swapped primary and secondary outcomes at that time and failed to mention any of this in the paper, which described the trial as if it were 100% prospective. This was, of course, false. These deceptive maneuvers violated core principles of scientific investigation and should have prevented the paper from being published by any legitimate medical journal. When I pointed out these issues to Archives of Disease in Childhood, a major BMJ title, the journal waited more than a year before finally slapping a 3,000-word correction on the paper and adding a 1,000-word editor’s note explaining with tortured logic why the study was not being retracted.

And yet the Norwegians have cited this disaster in promoting their own trial, with Professor Crawley serving as an advisor. And now the study administrators have demonstrated that they are prepared to act in a similarly unethical fashion by ejecting a participant for having some independent thoughts about the effort.  

Dumping participants who investigators believe might not benefit from an intervention is an effective way to skew study results toward the positive. If the trial produces purportedly positive findings, will the indication for the intervention include the requirement that you have to believe in advance that it will work? Unless this participant violated some specific and reasonable provision of the study guidelines, the decision to exclude them is highly problematic. Have any others expressed doubts about the Lightning Process, whether publicly or privately, and also been discharged?

Here’s how the letter explained the decision to remove the participant from the study:

“You were recently included in the study. According to information from some people involved in the study, you have over time […] been active in social media with criticism of a biopsychosocial understanding of ME and of professionals who have such an understanding. You have also been critical of the study in social media. This is of course completely legitimate and it is healthy to have professional discussions.

“On the other hand, motivation and a hope that the treatment will work is necessary for a psychoeducational method such as the one used in the study to be effective. Inclusion of people who have no motivation to participate in the study can create a situation that challenges the quality of the PhD work and the PhD candidate’s study environment, and can affect the other participants. The consequence of this could be that the study is affected in a negative direction, and as the person responsible for research, you understand that I cannot allow that.

“On the basis of possible adverse research-related consequences, I conclude as the research manager that you cannot otherwise participate in the study.”

Here’s part of Nina’s blog:

“The study participant who was excluded, Lena Kjempengren-Vold, says that she has always been open about her approach to the study. Despite her skepticism, she was genuinely motivated to participate and was open to following all instructions on the course in the hope that the method might be of help.

“Kjempengren-Vold has been ill since February 2022 and was diagnosed with ME one year ago. She had been through the first income interview and was approved by neurologist Jone Furlund Owe at Haukeland, who verified the diagnosis. The first round of the questionnaires used in the study had been completed.

“Kjempengren-Vold did not want to disrupt either the study or to influence other participants. Since it suited the travel route better and she had also discussed the study with the PhD candidate on Twitter, she asked if she could apply for admission with another instructor. According to the study protocol, several instructors must hold courses. She never got an answer to this. Instead, she received the letter with information that she is excluded from the study.

She writes: “Having worked in a research institution for 30 years, I am aware of the importance of inclusion and exclusion criteria being met. I also understand that when cognitive methods are used, the patient himself must “own the process” for any effect to be achieved, so yes; I was determined to practice what I learned on the course as well as possible based on my assumptions.”

You can read the rest of Nina’s post here.