By David Tuller, DrPH
In recent weeks, the Norwegian tabloid Dagbladet has published a series of articles about ME, which it also calls CFS/ME. These articles have promoted the use of the Lightning Process as an intervention, criticized patients and the Norwegian ME Association for expressing opinions about the Lightning Process and cognitive behavior therapy, and engaged in multiple other stupidities. The first articles ran a couple of weeks ago. The most recent one ran today.
Both Jonathan Edwards and I sent in letters in response to the first round of articles. Neither one was published. At least Professor Edwards received an acknowledgement that his letter had been received. I didn’t–even though the reporter mischaracterized me by omission when she referred to me as a blogger and journalist but forgot to mention the fact that I am a Berkeley academic.
I have posted both of our letters below–first Professor Edwards’, then mine.
I have read with concern recent articles in Dagbladet about a proposed trial of the Lightning Process for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME).
I have no personal or professional interest in CFS/ME but have been asked by a number of bodies internationally to advise on CFS/ME research, including the UK NICE guidelines committee. In my view significant disinformation is being spread by physicians in Norway about this proposed trial. I think it is important to establish certain simple facts.
1. The Lightning Process is a commercial product whose nature is secret and whose value is unproven €“ thus qualifying as an ‘alternative therapy’.
2. The previous trial of the Lightning Process failed to show benefit on its prespecified primary outcome measure. Subjective measures showed some improvement but since the trial was open label and the treatment involves cognitive manipulation this is to be expected as a result of bias. The trial was in other respects badly designed and executed.
3. The Lightning Process is not CBT. Moreover, contrary to suggestions quoted in Dagbladet, the evidence for efficacy of CBT in CFS/ME is not established. The results of the most extensive study, the PACE trial, strongly suggest no useful effect. Again, this was an open label study with subjective endpoints and therefore largely valueless. The improvements seen with CBT were considerably less than those seen in an open label study of the drug rituximab, by Drs Fluge and Mella, which we now know to be ineffective. In other words, CBT appears at best to have a placebo effect inferior to that of a drug that does not work.
4. The theoretical basis for these treatments has been shown to be either unfounded or contradicted by the evidence. There are further extensive problems with development of these treatments that are well documented in publications in peer reviewed journals.
5. The proposed trial of LP in Norway is another open label study and, with subjective end points, will be as valueless as previous studies. No physician would consider such a design adequate for drug therapy and there is no reason to think it is any more valid for therapist-delivered treatments €“ in fact very much the opposite. A robust objective component needs to be built into the primary endpoint.
6. From my perspective, criticism of these trials by patients, physicians and scientists like myself has nothing to do with ‘activism’ or with issues about whether the condition is physical or psychological. It is simply that this is poor research that serves the patient community very badly.
I think it is of serious concern that physicians and researchers in prominent positions are providing disinformation. Norway has been outstanding in its contribution to CFS/ME research in terms of epidemiology and drug studies (where negative results were reported as such). It is disheartening to see this tradition for rigour being abandoned.
Division of Medicine
University College London
Last week, a Dagbladet article regarding the controversy over a proposed Norwegian study of the Lightning Process mentioned me and my work. The reporter identified me as a blogger and journalist. She failed to mention that I have a doctorate in public health and hold an academic appointment at the University of California, Berkeley. (I do not have ME or CFS, nor do I have any family members who do.)
As Senior Fellow in Public Health and Journalism at UC Berkeley’s Center for Global Public Health, my main responsibility is to investigate the integrity of research in this field. My academic position is supported with donations to Berkeley made via the university’s own crowdfunding platform. Many patients and advocates have donated to Berkeley’s crowdfunding campaigns. The list includes the Norwegian ME Association, which publicly announced the donation. It is not uncommon for academic departments to receive funding from charities and patient organizations that support the work of faculty members.
While the Dagbladet article highlighted my funding, it did not address the unacceptable flaws of the 2017 Lightning Process trial. This study, which was conducted by investigators at the University of Bristol, has been cited in support of the proposed Norwegian trial. The Dagbladet article implied that patients’ opposition to the new Lightning Process research was unwarranted and based on prejudice rather than reason.
This is nonsense. The 2017 Lightning Process study, published in a BMJ paediatrics journal, violated core scientific principles. Last summer, a 3,000-word correction acknowledging multiple serious errors was appended to the paper. Last fall, more than 70 scientists, clinicians, and other experts from around the world signed an open letter to Dr Fiona Godlee, editorial director of BMJ, expressing dismay at the study’s ethical and methodological lapses.
To cite this questionable study in support of the Norwegian Lightning Process research is unjustified. To omit relevant information about my professional standing and credibility as a public health academic at one of the world’s leading universities is unacceptable.
David Tuller, DrPH
Senior Fellow in Public Health and Journalism
Center for Global Public Health
School of Public Health
University of California, Berkeley