Trial By Error: An Open Letter to Dr Godlee about BMJ’s Ethically Bankrupt Actions

Andy

Andy

Senior Member (Voting rights)
I have sent the following letter to Dr Fiona Godlee, editorial director of BMJ, about Archives of Disease in Childhood’s egregious decision to re-publish Bristol University’s Lightning Process trial with the original findings intact. Given the Bristol team’s flagrant methodological violations, the journal should have retracted the paper.

Failing that, Archives should have required the investigators to re-publish the paper with the initial primary outcome–school attendance at six months, which generated null results–as the final primary outcome. Dr Godlee was well aware of the issues involved, so she presumably endorsed the journal’s actions. The documented facts suggest that BMJ’s ethical compass is broken and that editors are more concerned about possible reputational damage than about the integrity of the medical literature or the health and well-being of children. That is presumably why dozens of scientists, clinicians and other experts from top academic institutions were so eager to sign this letter.
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http://www.virology.ws/2019/08/28/t...godlee-about-bmjs-ethically-bankrupt-actions/
 
chrisb said:
Would that be possible? Is it not all long gone?
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Of course their credibility is long gone in our eyes in our small corner of the medical world, but this takes it up a level, I think. They now have an open letter with international signatories, not just David Tuller fighting a lone battle.
But then it didn't help with the Lancet and PACE, so maybe I'm too hopeful.
 
Trish said:
Of course their credibility is long gone in our eyes in our small corner of the medical world, but this takes it up a level, I think. They now have an open letter with international signatories, not just David Tuller fighting a lone battle.
But then it didn't help with the Lancet and PACE, so maybe I'm too hopeful.
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The signatories are interesting. One or two different ones from U.K. Great to get a foothold in Birkbeck. Anyone know Keith Kahn- Harris’s background?

I just googled him. Useful interest in denialism in latest book.

http://www.kahn-harris.org/books/denial-unspeakable-truth/
 
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Binkie4 said:
https://me-pedia.org/wiki/National_ME_Observatory

I had not heard of this before, mentioned in the Guardian article above. Is it still active, faded away? The Guardian article was written in 2008 by the way.
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It led to the following study, which is probably the best prevalence study that has been done in the UK:
https://bmcmedicine.biomedcentral.com/articles/10.1186/1741-7015-9-91

BMC Med. 2011 Jul 28;9:91. doi: 10.1186/1741-7015-9-91.
Prevalence of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) in three regions of England: a repeated cross-sectional study in primary care.
Nacul LC1, Lacerda EM, Pheby D, Campion P, Molokhia M, Fayyaz S, Leite JC, Poland F, Howe A, Drachler ML.
Author information
1
Department of Nutrition and Public Health Interventions Research, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. Luis.Nacul@lshtm.ac.uk
Abstract
BACKGROUND:
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) or chronic fatigue syndrome (CFS) has been used to name a range of chronic conditions characterized by extreme fatigue and other disabling symptoms. Attempts to estimate the burden of disease have been limited by selection bias, and by lack of diagnostic biomarkers and of agreed reproducible case definitions. We estimated the prevalence and incidence of ME/CFS in three regions in England, and discussed the implications of frequency statistics and the use of different case definitions for health and social care planning and for research.

METHODS:
We compared the clinical presentation, prevalence and incidence of ME/CFS based on a sample of 143,000 individuals aged 18 to 64 years, covered by primary care services in three regions of England. Case ascertainment involved: 1) electronic search for chronic fatigue cases; 2) direct questioning of general practitioners (GPs) on cases not previously identified by the search; and 3) clinical review of identified cases according to CDC-1994, Canadian and Epidemiological Case (ECD) Definitions. This enabled the identification of cases with high validity.

RESULTS:
The estimated minimum prevalence rate of ME/CFS was 0.2% for cases meeting any of the study case definitions, 0.19% for the CDC-1994 definition, 0.11% for the Canadian definition and 0.03% for the ECD. The overall estimated minimal yearly incidence was 0.015%. The highest rates were found in London and the lowest in East Yorkshire. All but one of the cases conforming to the Canadian criteria also met the CDC-1994 criteria, however presented higher prevalence and severity of symptoms.

CONCLUSIONS:
ME/CFS is not uncommon in England and represents a significant burden to patients and society. The number of people with chronic fatigue who do not meet specific criteria for ME/CFS is higher still. Both groups have high levels of need for service provision, including health and social care. We suggest combining the use of both the CDC-1994 and Canadian criteria for ascertainment of ME/CFS cases, alongside careful clinical phenotyping of study participants. This combination if used systematically will enable international comparisons, minimization of bias, and the identification and investigation of distinct sub-groups of patients with possibly distinct aetiologies and pathophysiologies, standing a better chance of translation into effective specific treatments.

PMID:
21794183
PMCID:
PMC3170215
DOI:
10.1186/1741-7015-9-91
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Trial By Error: Calls for Retraction of the LP Study

Last week, when I sent Dr Fiona Godlee an open letter about the untenable decision by Archives of Disease in Childhood to republish the originally reported findings from the Lighnting Process trial, I cc’d many of the 55 signatories. Now three of them–Professor Ola Saugstad from the University of Oslo, Professor Racaniello from Columbia University (and host of Virology Blog), and Professor Elisa Ultra of Universidad Católica de Valencia San Vicente Martir–have sent their own forceful comments to Dr Godlee and the others cc’d on the original letter.

All three strongly support the case against the paper. Professor Saugstad and Professor Racaniello explicitly call for retraction. Professor Ultra questions why such a trial was even conducted, given the paucity of information available about the Lightning Process, and calls the published report “unsustainable.”

I am reposting their comments here.
 
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