PACE trial official complaint to the Lancet

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This page covers the offical complaint raised by Professor Hooper to the Lancet regarding the PACE trial.


In March 2011, Professor Hooper submitted a complaint to the Lancet regarding the publication of the PACE trial.

Complaint Document


On the 18 April 2011, Australia's national public broadcaster ABC aired an episode of the radio show 'The Health Report' on the PACE trial. The program was hosted by Dr Norman Swan and consisted of an interview with one of the authors of the trial, Professor Michael Sharpe, and an interview with the editor of the Lancet, Richard Horton. The entire program was devoted to proclaiming the PACE trial was a success and that the reactions from some people who claim to represent patients had been extraordinary. During the program Horton commented that a 43 page complaint had been received by the Lancet and that they would be attempting to conduct a scientific investigation into the claims within. [1]TRANSCRIPT

"Well we have been deluged with dozen's of letters raising serious objections to the conduct and interpretation of the study. Most recently a forty three page diatribe calling for the paper to be retracted based upon the fact that it is entirely invalid and unethical"

"...I think the criticisms about this study are a mirage. They obscure the fact that what the investigators did scrupulously was to look at chronic fatigue syndrome from an utterly impartial perspective"

"...this is where one sees a real fracture in the patient community. One is seeing a very substantial number of patients very willing to engage in this study, desperate to get good evidence on which to base their future treatment. But one sees a fairly small, but highly organised, very vocal, very damaging group of individuals, who have, I would say have actually hijacked this agenda and distorted the debate so that it actually harms the overwhelming majority of patients."

"Well, what we're doing right now is waiting for the formal response from the authors to this forty three page attack on their integrity and the study, and the request for retraction. We plan to publish their response to that attack. We will invite the critics to submit versions of their criticisms for publication and we will try as best as we can to conduct a reasonable scientific debate about this paper. This will be a test I think of this particular section of the patient community to engage in a proper scientific discussion."

Richard Horton, The Health Report: 'Comparison of treatments for chronic fatigue syndrome - the PACE trial' (ABC, 16 mins 40 sec in, 18 April 2011) [2]

On the 18 April 2011, Professor Hooper decided to place his complaint to the Lancet in the public domain as a result of the ABC radio show.

"In view of the content of the "Health Report" broadcast that was hosted by Dr Norman Swan on Australian radio (ABC Radio National) and the comments of Richard Horton, Editor-in-Chief of The Lancet, Professor Hooper has decided to place his complaint in the public domain forthwith so that people can read it for themselves and form their own judgment.

It is important to make very clear that ME/CFS is not a somatoform disorder but a serious multi-system organic disease"

Professor Hooper, FORUM THREAD: 'Formal complaint to Lancet about the PACE trial paper' (mecfsforums, 18 April 2011) [3]

On the 19 April 2011, Invest in ME wrote to Richard Horton to invite him, as editor of the Lancet, to the Invest in ME conference, in order that he may begin to learn about the disease ME.[4]

On the 17 May 2011, eight letters of criticism regarding the PACE trial were published in the Lancet. [5][6][7][8][9][10][11][12] Together with a response from the authors [13] and an editorial from The Lancets' editor, Richard Horton, who complained about having received the letters. [14]

On the 17 May 2011, The Lancet forwarded to Professor Hooper a response from the PACE trail authors. Significantly, in the letter, the authors admitted that they had not studied those who met the umbrella term used by NICE ("CFS/ME") or ME. In an initial response to this letter from Peter White, Professor Hooper pointed out that this was not what the PACE trial authors had previously stated.

"In their letter, Peter White et al state: “The PACE trial paper refers to chronic fatigue syndrome (CFS) which is operationally defined; it does not purport to be studying CFS/ME”.

The sentence continues by stating that the PACE Trial studied: “CFS defined simply as a principal complaint of fatigue that is disabling, having lasted six months, with no alternative medical explanation (Oxford criteria)”.

This is exactly what the ME/CFS community has been saying from the outset, namely that the PACE Trial was not studying those with ME."

“...there thus ought to have been no dispute that the PACE Trial Investigators were not studying those with ME, but the Investigators have persistently confirmed that they were studying those with ME,"

On the 28 May 2011, Professor Hooper sent a detailed response to Peter White's letter to Richard Horton, editor of the Lancet.

Correction to the Comment by Bleijenberg and Knoop in the Lancet

On the 6 June 2011, an email was sent to Zoe Mullan, Senior Editor at The Lancet, highlighting the incorrect statements made by Bleijenberg and Knoop in the article accompanying the published PACE trial. Specifically the claim of a 30% recovery rate with CBT and GET for the participants of the PACE trial. On the 8 June 2011, Zoe Mullan replied, stating that as recovery was not reported in the trial that they would be correcting the comment.


Professor Hooper's complaint to the Lancet regarding the PACE trial + Responses

Professor Hooper's complaint regarding the comment by Bleijenberg and Knoop in the Lancet

Radio interviews after the PACE trial

Response to the ABC Radio interview


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