I have not delved into the PACE trial in any detail, but just following on from Esther and Bob's comments if it was a government funded study, then would the data be obtainable under FOI application? If so, it might be worth obtaining and going from there
Also, for those of you have studied it and the report in the Lancet, was the lancet's reporting of the trial accurate and fair on the basis of the material presented in the study itself?
1. Good idea ISO
2. I don't think so. The editorial was particularly dangerous because of its reifying of the claim of CBT/GET being safe for patients with ME.
1. The authors cleverly withheld the data when they published the study, so we couldn't respond to the Lancet with a full analysis. I was expecting them to release the data in time, though, at some point in the future. If they aren't intending to release the data, then I expect we should be able to get it through a FOI. I can't foresee any reason why we wouldn't be able to.
2. The editorial and the conclusions of the paper have a lot to do with the use of wording, such as 'moderately effective' treatments, and 'safe treatments'. It's not straightforward to challenge the use of the word 'moderate' because it's such a vague descriptor, although I believe that it is used incorrectly and there is a very strong case that it should be replaced with the word 'minimal' or 'minimally effective treatments', based on the results of the study. So unfortunately, we are reduced to arguing about semantics, because of the clever use of words by the authors.
With regards to the word 'safe', I think we are in need of the raw data to check this, because they didn't provide the data for exactly how each patient reacted to the treatments, and how many patients got worse after treatment.
It's also not straightforward for us to challenge the words 'safe' and 'moderately effective' because the study was designed to exclude the most severely ill patients from the study, along with using unofficial diagnostic criteria which allows inclusion of patients with idiopathic or psychiatric related fatigue. So the whole basis for the study is flawed, and the results should not be extrapolated to be used in relation to the disease ME, or even to 'CFS' as it is defined in the UK or USA, and they should not be extrapoloated to be used for ME patients with any severity of illness. However, I believe that the authors do
not qualify their statements about 'safe treatments' or 'moderately effective treatments'. They imply that the results of the trial applies to all ME patients.
These are the reasons that I would call it fraudulent, rather than there being discrepancies. Not only has the data been presented in the conclusion with an immense amount of unscientific spin, but the study is set up on a false premise in the first place, and the conclusions have been extrapolated to relate to everyone with ME when they didn't use the official diagnostic criteria, but used a more heterogeneous criteria, and they didn't include severely ill patients in the trial.
But I agree that we don't need to argue about the use of the word 'fraudulent'... If we are talking about it as a legal term, then it would be extremely difficult to prove fraud in a court... I agree with Esther that we all agree on how appalling the study was.
Fraud: "intentional deception resulting in injury to another person". I think that just about covers the PACE Trial! But maybe not in a legal sense.