By David Tuller, DrPH
Last year, Archives of Disease in Childhood slapped a 3000-word correction on a University of Bristol study of the Lightning Process. The lead investigator was Bristol’s ethically and methodologically challenged pediatrician, Professor Esther Crawley, who failed to disclose to the journal that the study had violated core scientific principles.
As I have previously stated, the study appears to meet both UK and US standards for research misconduct. It is indisputable that the journal would not have accepted the study had Professor Crawley and her team of experienced researchers been honest about the fact that they retrospectively registered more than half the participants and swapped outcomes midway through. The journal’s decision to let the findings stand despite these anomalies was a disgrace–as indicated in the astonishment expressed by more than 70 experts in a letter I organized last fall and sent to Dr Fiona Godlee, editorial director of BMJ.
Nonetheless, according to recent news reports, Norwegian researchers are plowing ahead with a Lightning Process study of their own. A request for funding for a similar study was turned down by federal last year. Now Live Landmark, a long-time LP practitioner and proponent, has revived the proposal as a research project affiliated with her current enrollment in a graduate program in psychology. Although this iteration appears to have received financial support, it has not obtained ethical approval, according to Nina Steinkopf, a blogger and activist who has been tracking the situation.
Here’s a link to what Steinkopf wrote on Thursday. The post below is from Google Translate. I will take a look at the study design in a subsequent post.
Contested LP study is not approved yet
April 30, 2020 · at melivet
For two days in a row, NRK P2 / Ekko has had information about the controversial, planned study in which ME sufferers will be treated with the alternative method Lightning Process:
“Now, large sums will be invested in researching a treatment for ME sufferers”.
I have been in contact with Regional Committees for Medical and Health Research Ethics (REK) at NTNU in Trondheim today and asked if the project is approved. They respond that:
“We have not received any application for this study yet. It looks like the study is in the planning phase and has not started. The study must be approved by us before start-up so I expect there will be an application for us in the near future. ”
The REK’s website states that the next scheduled meetings are May 5, June 9, August 18, September 22, November 3 and December 8. The treatment time is approx. three weeks after the committee has considered the application.
The radio broadcast stated that the strict Canadian criteria should be used in selecting study participants. Prof. Vegard B. B. Wyller, who is a project co-worker in the study, said that the study must have the same strict research method requirements as in drug research.
General Secretary Olav Osland of the Norwegian ME Association was also interviewed. He expressed concern that public institutions are investigating alternative treatment that has been shown to harm patients. To that Wyller replied that:
– In the studies we know of similar techniques, no harmful effects have been detected at all. The research project is there to map this out – well, right ?! The benefits we think are far greater than the disadvantages – we think it is ethically justifiable to do so.
Wyller has long recommended that ME-sick children be treated with LP. Read more in NRK: 13-year-old attempted suicide after ME course
The Research Council granted up to NOK 1,767,000 for the project on April 3. The project manager is Professor of Psychology, Leif Edward Ottesen Kennair. 20 municipalities in Viken are invited to participate. Currently, it is known that 2 municipalities have accepted yes; Lørenskog and Aurskog-Høland.
The project description states, among other things. that “there seems to be a ‘social contagion’ of the diagnosis and incidence may be higher in a small part of the municipality than in the municipality as a whole. This may indicate that there are more factors than the purely medical ones at play. ”
Read more about 17 patient experiences here: Lightning Process is harmful to ME patients