By David Tuller, DrPH
In a welcome display of scientific acumen, Norwegian research ethics authorities have rejected a proposed study of the woo-woo called the Lightning Process as a treatment for ME/CFS. Since Norway generally appears to be a hotbed of biopsychosocial thinking, this excellent decision is a bit of a surprise. It follows a heated public debate about the issue over the last year, both before and after regional ethics authorities granted initial approval to the study in November.
(Dagbladet, a popular daily publication, ran an opinion piece of mine last June about the issue. In April, Codastory.com, an international news site, published my lengthy investigation of the Lightning Process, which highlighted the proposed Norwegian study.)
The regional ethics committee received multiple complaints about the approval from individuals as well as the Norwegian ME Association, but declined to change course. After reviewing the matter during meetings in March and May, the National Research Ethics Committee for Medicine and Health Sciences (NEM) released a statement on June 4th that it was rescinding the approval, noting that the decision was â€˜unanimousâ€ and â€œcannot be appealed.â€ In other words, the researchers would have to redesign their study and develop a new proposal if they choose to proceed with their misbegotten LP research.
The study was to include 120 newly diagnosed patients, with one group receiving the Lightning Process intervention and the other being placed on a waiting list. After an assessment period at ten weeks, the waiting list group was also slated to receive the Lightning Process. While some longer-term outcomes were also part of the proposal, the study design meant that there would be no comparison group at that time period, since all the participants would have undergone the training. Without a comparison group, the long-term outcomes would have been essentially meaningless.
The NEM was unequivocal in its rejection of the application. A major point involved the studyâ€™s reliance on subjective outcomes, with the committee astutely observing that the intervention itself was likely to influence how patients reported their results. (After running the following passages through Google Translate, I have edited them lightly for grammar and clarity.) According to the NEM statement:
â€œA weakness of the project concerns the evaluation of the effects of the interventionâ€™s use of questionnaires, and that the intervention partly deals with how to respond to questions about one’s own health. NEM believes that the method poses a risk that the intervention could have an effect on the responses from the participants for reasons other than real improvement. As NEM perceives the intervention, a key part of what participants learn will be to overlook negative symptoms and to put the spotlight on positive experiences. They are also encouraged to use active language, avoid thinking of [their] own limitations, and to reinforce [their] progress. The change in the way of thinking could significantly color the answers given in the questionnaire immediately after the courseâ€¦NEM believes that it would strengthen the project if there had been several objective, primary endpoints in the evaluation.â€
But the projects â€œgreatest weakness,â€ declared NEM, is that the lead investigator, Live Landmark, is herself a Lightning Process practitioner whose control over the project would have raised serious concerns about the reliability and validity of the findings. The NEM noted that â€œthe research fellow’s active role in all stages of the project, and the conflict of interest that arises because the research fellow has strong business interests in the project providing positive results.â€ In particular, NEM questioned the decision to allow the lead investigator to pre-screen potential study subjects:
â€œThe conflict of interest is most evident in the selection of the participants, which primarily takes place on the basis of a conversation with the research fellow. There is a possibility that method means that only those who initially have the greatest potential for improvement are included. Further, NEM believes that it is a problem that the selection appears to be based on subjective assessments.â€
In other words, if the main investigator is actually helping to select participants to make sure they are appropriate candidates based on her subjective assessments, it would be impossible to extrapolate the findings to a larger pool of ME/CFS patients who were not similarly identified. This, in turn, would lead to widespread distrust of the reported results, according to NEM:
â€œIf society is to listen and have confidence in research results, it is important that there is no doubt that the researcher is primarily guided by a desire to gain new knowledge in an objective and trustworthy manner. Projects where justified and serious questions about conflicts of interest can be asked will not achieve the necessary trust. In a controversial field of research, which research on Lightning process must be said to be, this is particularly relevantâ€¦NEM considers that the project is not to be considered justifiable, and cannot implemented in its current form.â€
Professor Vegard Bruun Wyller, a professor at the University of Osloâ€™s Institute of Clinical Medicine and a leading proponent of the study, has not yet respond to my request for comment on this latest development. I assume Professor Wyller, like other members of the biopsychosocial ideological brigades, is not favorably disposed towards me, especially since I publicly critiqued his bogus study of cognitive behavior therapy plus music therapy for preventing chronic fatigue after mononucleosis (aka glandular fever). That study sure seemed to call out for an investigation into possible or likely research misconduct. However, BMJ Paediatrics Open gave it a pass by publishing an updated version insteadâ€”although the republished paper failed to fixed all of the egregious problems. As with previous actions in this domain of science, this decision undermined any claims from BMJ that it is dedicated to recognized standards of research integrity.
The negative decision will also likely disappoint Professor Esther Crawley, the ethically and methodologically challenged pediatrician and star researcher from University of Bristol. She presumably would have hoped that positive findings would help rehabilitate her earlier study of the LP in kids. Although that study was slapped with a 3,000-word correction two years ago after I exposed its egregious failings, its findings remain in the literature and continue to be cited by proponents as if it were a legitimate source of knowledge. (It is not.)
Besides the Norwegian ME Association, much of the credit for this victory must go to Nina Steinkopf, a Norwegian patient and advocate who has blogged repeatedly about the problems with the study. Way to go, Nina!! She wrote about the rejection of the study here.