Does The Lancet care about patients? by Leonid Schneider, April 5, 2016
This blog post by a Dutch science journalist questions the Lancet’s track record on a number of issues including the PACE trial. Below is an extract. Read the full article online and comments by a number of people follow the item, including Dr Ellen Goudsmit.
The Lancet, an elite medical journal published by Elsevier, is responsible for a number of controversial publications, on which its Editor-in-Chief Richard Horton and his editorial office have not always acted to everyone’s satisfaction…
The Lancet and data sharing
This clinical trial dealt with medical efficiency of different therapies for chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME, well explained in this recent Guardian article). Just as the aforementioned Le Blanc’s Lancet paper, also the PACE trial apparently passed off patients, who were not sufficiently ill to begin with, as recovered to demonstrate the efficiency of exercise therapy. This, if true, is no minor thing, but puts the integrity and validity of the entire study in doubt.
According to an open letter to the EiC Horton by six critical scientists, PACE trial was based on:
“an analysis in which the outcome thresholds for being ‘within the normal range’ on the two primary measures of fatigue and physical function demonstrated worse health than the criteria for entry, which already indicated serious disability. In fact, 13 percent of the study participants were already “within the normal range” on one or both outcome measures at baseline, but the investigators did not disclose this salient fact in the Lancet paper. In an accompanying Lancet commentary, colleagues of the PACE team defined participants who met these expansive ‘normal ranges’ as having achieved a ‘strict criterion for recovery’”.
Since there were also a number of other heavy concerns about the PACE trial’s set-up, an independent re-analysis of data could surely bring light into the controversy. Yet the authors of this Lancet publication (and a follow-up paper in PLOS One) steadily refuse to share the anonymised patient data (with non-collaborators, that is), citing various reasons. The courts are about to decide on the matter of data release soon.
CFS/ME is not a kind of hysteria it was thought to be, but apparently a very complex and severe clinical phenotype covering a wide range of physiological and psychological disease origins. Yet it is quite clear where Dr. Horton stands: he staunchly defended the PACE trial paper in a radio interview in 2011, insisting that “it’s been through endless rounds of peer review and ethical review” and that “the criticisms about this study are a mirage”. The journalist David Tuller, who was investigating the PACE trial controversy from the beginning, commented to me:
“The Lancet has not explained how this piece of nonsense could possibly pass peer review. It has not even acknowledged that it published a paper with outcome thresholds lower than entry criteria, so that you could be simultaneously “within normal range”–one of the study’s measures for improvement–and disabled enough to qualify the study. That is not hidden or tucked away! It right there in the study.
It should have been noticed by anyone who read the study carefully.
For a paper to include this analysis is absurd. For a journal to publish it and then not acknowledge such a fundamental flaw after it has been pointed out repeatedly, including in correspondence in the journal itself, is also absurd”.