The Regional Committees for Medical and Health Research Ethics (REK) in Trondheim, Norway, has received an application for ethical approval of a study in which 100 ME patients will be treated with the alternative method Lightning Process (LP). PhD candidate is LP instructor Live Landmark.
This is a collaborative project with researchers from the Norwegian University of Science and Technology (NTNU), the University of Oslo, as well as the National Institute of Public Health (Fhi) and the University of Bristol. In addition, it is stated that The Norwegian Labour and Welfare Administration (NAV) will inform and recruit clients, and also contribute with information about the participants. The Research Council of Norway has funded the project with 1.8 mill. NOK.
I have evaluated the application and found that there are a number of serious concerns associated with the study. Here are some key points:
- The method is called «A 3-day biopsychological intervention for chronic fatigue/myalgic encephalopathy (CFS/ME) in adults: a randomized, controlled trial». The project application is 61 pages long. It’s not until page 51, in the invitation to study participants, that it is informed that «We will use the course Lightning Process» (LP).
- The method is called a «biopsychological intervention». That’s misleading. There is nothing «bio» about either the method or the study’s measurement points.
- The research group fails to inform that the Norwegian Directorate of Health, the Norwegian Consumer Authority and Norway’s National Research Centre for Complementary and Alternative Medicine (NAFKAM) classify the method as alternative treatment.
- The study is described as randomized and controlled. That’s misleading. There is no real control group, all participants receive the same intervention.
- The research group fails to mention that the candidate is not a trained health care worker. It is unjustifiable that seriously ill people are to be treated with an alternative method by someone who is not subject to the requirements of the Health Personnel Act.
- It is unethical that the research group give the impression that it is not known that many have had a negative effect of the method, and that they do not disclose reported side effects.
- It is not true that the method can be compared to, or may be reminiscent of cognitive therapy. It is also not true that cognitive therapy has shown a positive effect on ME, or without documented side effects.
- Patients are to be included according to the Canada criteria. In the studies to which the research group refers, these criteria have not been used. In other words, the project is based on research that has been done on other patient groups than those that are to be included in the study.
- The research group fails to inform of the controversies surrounding, and the warnings regarding, the studies which they refer to.
- The project is based on a hypothesis that ME is “sustained arousal”. This hypothesis has been tried for 15 years without success. It has not been documented that ME is a psychosocial or psychosomatic disorder.
- The application claims that «Extended rest after listening to the body is an example of inappropriate adaptation and mislearning.» This is harmful false teaching and contrary to current knowledge about the disease.
- The core symptom of ME is post exertional malaise. In LP courses, participants learn that the method works on the condition that they tell themselves and others that they are healthy. The consequences are that they do not listen to the body’s signals, override the symptoms and extend beyond the tolerance limits – which in turn can lead to worsening of symptoms – in worst case; severe and permanently.
- Reporting of side effects will be difficult for the participants as it is contrary to what they are told about the condition and for the method to have a positive effect. Measurement of effect will therefore hardly be accurate.
- The candidate influences all participants with pre-screening, selection, psychoeducation, intervention and in follow-up interviews. It is worrying that the participants are given incorrect information about the disease, and that they are influenced in advance with such hypotheses.
- It is worrying that the candidate wants recently diagnosed patients («new» cases). These patients may have less knowledge about the disease and may to a greater extent have faith in what they are told about the disease and the method.
- Lack of or negative effect is in advance attributed to the participants ‘personality and their alleged «fear». The responsibility for negative or lack of effect is thus transferred from the method to the patient. This is very worrying.
- The organization Recovery Norway shall contribute with «user involvement». It is not mentioned that RN was created by i.a. LP instructors or that the manager is a MD and not a patient. How genuine is external user involvement from a user organization that the candidate herself helped to establish?
- The effect of the method shall be measured by school- and work attendance, and by the answers from 13 questionnaires (132 questions) which shall be completed 4 times. The questions are related to physical function, fatigue, pain, post exertional malaise, mental well-being, quality of life, anxiety and depression, quality of relationships, personality, illness perception and insomnia. One of the questions is: «How sexually intense is your relationship?»
- According to the candidate, 5,000 Norwegians have taken the course. There are approx. 30 people with a ME diagnosis in Norway who have registered a positive effect. NAFKAM’s study on the effect of the method on patients according to the Canadian criteria showed that 40% had a negative effect. Would a drug study with a similar side effect rate be approved by REK?
Professor of Psychology Brian Hughes at the National University of Ireland, Galway:
«I do not describe the Lightning Process as a biopsychological intervention. To describe LP as «biopsychological» assumes that it is partly biological and partly psychological. This is incorrect. Both biology and psychology are evidence-based sciences. LP is clearly not.
A better description would be Alternative Medicine, or indeed Alternative Science. It is grounded on assumptions about the human body and mind that have no scientific basis (for example, the principles of Neurolinguistic Programming — scientifically discredited for many years). In that sense, LP is an unambiguous example of pseudoscience.
I recognise that even pseudoscientific interventions should be subjected to scientific scrutiny. However, there is an ethical question regarding the use of known pseudo-therapies in vulnerable groups, even for research purposes. In my view, LP presents a significant ethical challenge in this regard.»
REK states that «the application shall be assessed by the committee at a meeting on 19th August 2020″ and that it usually takes seven weeks from the deadline for which the application is submitted until the applicant receives a decision with REK’s assessment.
I hope REK also considers how a study on LP is justifiable in relation to the several thousands of Norwegian and international studies where physiological findings have been made; findings showing that ME patients have a failure in the mitochondrial energy production, inflammation in the central nervous system and abnormalities in the immune system.
Written by Nina E. Steinkopf
Former Health, Safety- and Quality Director in international petroleum industry, now; ME-patient and patient advocate
Read more: Researchers claim NAV has an active role in a controversial study. NAV rejects this.
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