By David Tuller, DrPH
Last last month, I resent Dr Fiona Godlee a letter criticizing BMJ’s decision to republish the Lightning Process study with the same findings. The first iteration, in July, was signed by 55 scientists, clinicians and other experts. This version was signed by more than 70 experts and over 60 patient and advocacy organizations. After I sent the previous version, more than a dozen of the signatories followed up with letters of their own to Dr Godlee.
Below are two more recent ones. The first is from my Berkeley colleague, infectious disease professor emeritus John Swartzberg, who is also editorial director of the Berkeley Wellness Letter and BerkeleyWellness.com. The second is from Dr Susan Taylor-Brown, a retired pediatrician at Golisano Children’s Hospital at the University of Rochester.
Dear Dr. Godlee,
Thank you for your efforts in maintaining the high quality of the BMJ.Â I am a professor in the School of Public Health at the University of California, Berkeley.Â As editor of the UC Berkeley Health and Wellness Publications, I appreciate how difficult it is to uphold the highest standards of journalistic integrity.
I do think the BMJ seriously slipped when it decided not to retract the article â€œClinical and Cost-Effectiveness of the Lightning Process.â€Â The following is a partial list of some of my concerns:Â It was not a randomized controlled trial as the authors stated; protocols are portrayed as predesignated but in fact were not since they were swapped midwayÂ through the study; there was poor participation for questionnaire participation; and the research was conducted in such a way as to increase confirmation bias.
While the above reasons are sufficient to retract this paper, I believe the strongest reason is that it harms the very children it claims to help.Â Its reported findings have the potential to cause severe damage to young ME/CFS patients.Â It can give false hope and potentially cause patients to have a serious relapse.
I urge you to retract this damaged and damaging paper.
John Swartzberg, MD, FACP
Dear Dr. Godlee:
I am writing to address the â€œCorrectionâ€ published inÂ Archives of Disease in ChildhoodÂ and urge you to consider retracting this publication.Â Children are a protected class of research subjects. The Lightning Process article failed to adhere to the principle of protecting vulnerable children who are diagnosed with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).Â There is growing evidence that ME/CFS is a neuro immune disorder that has significant impact on a personâ€™s ability to function (Freidberg, Sunnquist & Nacul, 2019,Â Institute of Medicine, 2015); not a psychosomatic illness as assumed by the Lightning Process authors.
Since the early 1990s, multiple studies have compared patients with ME/CFS with healthy age- and sex-matched controls and found abnormalities of the central and autonomic nervous system (Komaroff & Cho, 2011). An analysis of large international patient surveys (Kindlon, 2011) found that over 50% of patients reported that CBT and GET not only fell short of delivering significant improvements but often let to worsened health due to ill-advised activity and exercise prescriptions. Blease, Carel, & Geraghty (2017) note that the failure to address these negative outcomes appears to be the result of skepticism of ME/CFS. Experienced clinicians do not recommend PACE-type GET or CBT as treatments (Friedberg, Bateman, Bested, Friedman, Gurwitt, Lapp, & Vallings, 2012).
It is unfortunate that the authors of the Lightning article addressed the Lightning Process correction rather than an independent panel of ME/CFS experts. This study appears to be the contemporary example of a poorly designed, unethical research study that fails to protect pediatric subjects. This study will be used as an exemplar of poorly designed and implemented research. As researchers, we are to do no harm; the Lightning Process fails to protect children and must be retracted.
SusanÂ Taylor-Brown, PhD
Blease C, Carel H, Geraghty K. Epistemic injustice in healthcare encounters: evidence from chronic fatigue syndrome. J Med Ethics. 2017;43(8)549â€“557.
Friedberg, F., Sunnquist, M, and Nacul, L. Rethinking the Standard for Care of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. J Gen intern Med (2019)
Friedberg F, Bateman L, Bested AC, Friedman KJ, Gurwitt A, Lapp CW, Vallings R. ME/CFS: A primer for clinical practitioners. Chicago: International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis. 2012.
Institute of Medicine. Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness. Washington, DC: National Academies Press; 2015.
Kindlon T. Reporting of harms associated with graded exercise therapy and cognitive behavioural therapy in myalgic encephalomyelitis/chronic fatigue syndrome. Bull the IACFS/ME. 2011;19(2)59â€“111. Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness. Washington (DC): National Academies Press (US); 2015 Feb.