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False results from a flawed trial

Posted by IiME on 01 Aug 2012 at 21:41 GMT

From Professor Malcolm Hooper's summary of the Pace trial -prepared for "Briefing Notes for Meeting with BIS Officials About Incorrect Answers to Parliamentary Questions re: the MRC-funded PACE Trial and ME/CFS"

The PIs themselves concede that:
“Our trial had limitations. We excluded patients unable to attend hospital”;
“Results cannot be extrapolated to those who are severely affected”; that “primary outcomes were subjective”
and that
“What this trial isn’t able to answer is how much better are these treatments than really not having very much
treatment at all”.

What the PIs failed to acknowledge was that their ignoring of the biomedical evidence about the disorder they were
supposedly studying (breaching the Declaration of Helsinki B11) invalidated the entire trial in that it was not
grounded on the existing evidence-base and thus contravened the most basic principle of scientific research.

After a trial lasting nine years and costing £5 million, the PACE Trial has not taken us forward: not only have the results
been misrepresented, but safe guidance on management options must address the needs of all patients with ME/CFS
and it is not the case that the PACE Trial results are generalisable to all people with the disorder as claimed by the PIs.

The problematic analysis and selective presentation of data means that the PACE Trial has failed to provide “high
quality evidence”, which is an unacceptable outcome: patients, clinicians and tax-payers have a right to expect higher scientific standards from the MRC.

The PACE Trial failed on a fundamental aspect of clinical research in that the benchmarks used to judge suitability for
entry to the trial and successful outcomes are patently contradictory.

The need for independent statistical re-evaluation of the raw data is overwhelming as, without such an independent
assessment, doubts over the veracity of the claims made by Professor White et al cannot be resolved.

Furthermore, the post-publication admission by the Chief Principal Investigator that the study was ‘not purporting to
be studying CFS/ME’ invalidates the whole study which claimed to be addressing CFS/ME.

Given (i) the inability of the recruitment criteria to distinguish between ME/CFS and psychogenic fatigue, (ii) the illogical
overlap of the entry criteria with “the normal range”, (iii) the failure of CBT to achieve a clinically useful difference for
one of the primary outcomes and the trivial improvement produced by GET, (iv) the failure to recognise that an
“averaged” improvement often masks very different responses to an intervention, and (v) the fact that around two
thirds of participants who received CBT/GET remained in the lowest functioning 10% of the general population, the
international ME community wonders why the PACE Trial is being hailed as a “gold standard” study which
demonstrated the efficacy of CBT and GET for ME/CFS patients (as noted above, although the Protocol refers to it as an
RCT [randomised controlled trial], The Lancet paper at no point describes PACE as a controlled trial, yet it was described
in the press release as “the highest grade of clinical evidence” and as “extremely rigorous (and) carefully conducted”),
which by any standards is risible.

Despite the irrefutably poor results of the trial, CBT and GET are being actively and inappropriately applied to people
with ME/CFS; the PACE press release stated that the results suggest: “everyone with the condition should be offered
the treatment” and that every patient “who wishes to be helped” should be willing to take part in such regimes.
Non-compliance (for example, if a person has already found that exercise exacerbates their condition) is deemed to
demonstrate lack of desire to recover, which in some instances has already led to the withdrawal of state and/or
insurance benefits.

The PACE Trial was not a scientific study and defies reason but, given the considerable investment (Governmental,
financial and professional) in its success, it could not be allowed to fail.

Magical Medicine!

No competing interests declared.