The Light of Day

After long opposition (and substantial expense) from the trial investigators and Queen Mary University of London, data from the £5m publicly funded PACE Trial, which studied graded exercise (GET) and CBT therapies for ME/CFS, has finally been released under the Freedom of Information Act. ME patients Alem Matthees, Tom Kindlon and Carly Maryhew, with the support of two prominent US statisticians, have reanalysed the data according to the original trial protocol and illustrated that the recovery results were exaggerated by a factor of four due to unexplained protocol changes. The revised results were in fact statistically insignificant. This means that , in spite of what the investigators claimed, the trial provided no proof that GET and CBT help people with ME/CFS to recover.

Though those who have studied the trial have long suspected that the results as originally presented were grossly misleading, it is still a “gosh- wow” moment to actually witness the proof of this. One is tempted to ask “How did they think they would get away with what appears to be such a deliberate attempt to mislead?”

The answer appears to be that they calculated quite cleverly: they almost did get away with it. The professional reputation of the investigators had led many prominent people to assume that they must be in the right, and that the ME patients who have been fighting to expose the truth (whom the PACE investigators branded as ‘a fairly small, but highly organised, very vocal and very damaging group of individuals’) were unreliable obsessives, eager to discredit the trial simply because its conclusions did not agree with their own beliefs about ME. (In actual fact, the attempt to besmirch the patients in this way appears to have been a classic case of ‘projection’, the investigators having apparently twisted the figures to fit their own mistaken beliefs about the condition.)

Even now, it seems likely that they will stick to the strategy of claiming that black is white and relying on their reputations to carry the day. Just before the release of the data, the investigators put out a revised analysis (according to the original protocol) of the improvements reported by patients in the trial, which when compared to the originals showed that these had been exaggerated by a factor of three in the published paper. In spite of this glaring difference, which rendered the results – once again – statistically insignificant, the investigators announced that these outcomes were ‘very similar’ to the results reported in the original paper.

More recently, in response to the reanalysis by Matthees et al, Sir Simon Wessely, president of the UK Royal College of Psychiatrists, who might be regarded as the godfather of PACE, told statistician and ME patient Julie Rehmeyer that his reaction was “OK folks, nothing to see here. move along please.” So it seems like they are indeed going to keep on pretending there’s nothing wrong and hope that no one important notices. His choice of words (“nothing to see, move along please”) seems chillingly pertinent to this strategy. They are indeed hoping that if they say there’s nothing to see, people will see nothing. What we need is for those in authority to stop and look for long enough to notice that these emperors have no clothes – and to act on the implications of that.

Because there are very important implications. As Metthees et al put it: ‘pending a comprehensive review or audit of trial data, it seems prudent that the published trial results should be treated as potentially unsound, as well as the medical texts, review articles, and public policies based on those results.’

The NICE guidelines currently recommend the use of GET and CBT for people with ME (other than the severely affected). They predate the PACE Trial but nevertheless PACE is seen as the most substantial pillar of evidence supporting their use. There is therefore now a good case for their immediate suspension and review, especially as patient surveys and substantial anecdotal evidence indicate that GET in particular can cause substantial harm to patients. The US Agency for Healthcare Research and Quality (AHRQ) has already adjusted its advice, accepting that ‘there is insubstantial evidence for the effectiveness of GET’ and little for CBT. It is high time the NICE guidelines here in Britain were also put on hold.

The same goes for the MAGENTA Trial, which is effectively a PACE Trial for children. Always controversial, there is surely now no excuse for proceeding with this trial which will subject the young participants to a treatment which patient experience suggests is likely to cause long term harm. The trial seems especially outrageous and unnecessary when there is such substantial anecdotal evidence that children (unlike adults) stand a very good chance of full recovery when they are simply allowed to build back their strength at their own rate.

ME patients, with the help of David Tuller and others, have done a remarkable job in the ‘David and Goliath’ battle to expose the truth about PACE. We owe all those involved a debt of thanks. Now it is time for those in authority to open their eyes to what has occurred and take action. An independent, comprehensive review of PACE is certainly needed, not least to ascertain whether it was an appropriate use of public money. Until that happens, we all have to carry on putting the word out there. It has taken so long but we are starting to get it across…