White In Denial

We’ve had to put up with decades of nonsense about ME in the press but today’s Guardian article by Peter White of the PACE Trial has to be the worst I’ve seen. It wasn’t easy to leave a comment on the article while shaking with anger but I did my best. Here’s what I wrote. I’m pleased to say that many others were making powerful points at he same time.

Following the recent release of data from Peter White’s PACE trial (by order of a Freedom of Information tribunal, £250,000 having been spent in attempting to stop it) PACE has finally been revealed as the travesty of the truth it always has been. Rather than give the appropriate heartfelt apology, however, Prof White continues in denial.

The blog to which he disparagingly refers was written by patients who have used energy they can ill afford to spend in a David-and-Goliath struggle to reveal the truth about this reprehensible study. With the aid of expert statisticians they have not distorted the figures, as Prof White implies. What they have done is to use the newly released data to analyse the results in line with the trial’s original protocol, which White and his fellow authors originally declared they would use but then changed their minds as it didn’t give them the outcomes they wanted. They never gave a satisfactory explanation for this change but it now seems pretty obvious why it happened. The newly reanalysed results show that GET and CBT are of no more use than a placebo. They are worthless for ME/CFS, but White and his associates refuse to admit it as they have built their life’s work on these therapies. Therapies which, moreover, have been shown to be harmful for patients with ME/CFS in numerous surveys. Patients have ended up housebound or bedbound for years on end because of the efforts of White & Co, but still they refuse to admit they have done anything wrong.

This change of protocol was only the tip of the iceberg in terms of the study’s shortcomings. The Criteria used to select subjects for the study included patients with other fatigue conditions; the numerous changes in protocol meant that patients could be ill enough to join the study, deteriorate during it, yet still be classed as ‘recovered’ at the end; objective outcome measures which actually measured patients’ abilities were abandoned in favour of questionnaires; conflicts of interest on the part of the investigators were not disclosed to study participants, the list goes on and on…. In years to come, PACE will be used as an example of how NOT to conduct a research study.

 

P.S. The most complete analysis of the many shortcomings of the PACE trial is by David Tuller. The article, Trial By Error,  is in several parts. There are links to all of them here. If you just read the summary though, at the opening of part one, that tells you a lot.

MEGA Petition

Here is a copy of an email from Leeds ME Network sent to Sonya Chowdhury, CEO of Action for ME concerning the petition which she has been circulating regarding the proposed ‘big data’ study by the UK CFS/M.E. Research Collaborative. It is another situation, similar to the NIH study in the US – where the research sounds very promising but some of the personnel involved sound alarm bells. Leeds ME Network are therefore requesting more details and – hopefully – reassurances.

Dear Sonya – I am writing because I find it difficult to know how to respond to the MEGA petition which you have been promoting. Of course I am in favour of more biomedical research into ME. Normally I would sign this petition, circulate it to our members, and publicise it more widely on social media. Yet I am concerned about the presence of  Profs White and Crawley in the MEGA team. I am sure you are aware that many other patients share my reservations.

Following the recent release of data, it is now clear that Prof White and his PACE team deliberately manipulated the data to get the result they wanted, thereby deceiving patients, doctors, and decision makers both in this country and worldwide, Action for ME included. I know that your predecessor, Sir Peter Spencer, expressed surprise at the results of the PACE Trial. Well he might have done, because it is now clear that the published results were a travesty of the truth.

As for Prof Crawley, as you will be aware she is now about to test GET on children in the MAGENTA trial (in spite of widespread concerns about the PACE trial plus substantial reporting by patients of harms from this therapy), has recently been testing the quack therapy the Lightning Process on children, and has added to the substantial body of misinformation about ME by conducting a study of the prevalence of CFS at age 16 by using subjects who were ‘diagnosed’ by questionnaire and without the involvement of doctors.

In view of these issues. I’m afraid I have no confidence in any research involving either Profs White or Crawley and am therefore loath to sign or distribute the petition. But on the other hand, I would very much like to support biomedical research. I therefore feel I am caught between a rock and a hard place and it seems that many other patients feel the same.

I notice that ME Research UK have put a slightly different list on their web site: a ‘main MEGA team’ which does not include Profs White and Crawley. This makes perfect sense, as it is hard to see why either of them, given their skill sets and the nature of their previous work, should be involved in biomedical research anyway. So I wonder if their presence on the petition page is a token one only, acknowledging their membership of the Research Collaborative perhaps? If this were the case, if Profs White and Crawley were not actually to be involved in the big data project (and therefore not at liberty to subvert it), I might well feel able to support and publicise the petition. I wonder if you are able to advise me on this or else pass this email on to someone else who can?

I have just being listening to your presentation at the Research Collaborative conference in which you spoke very tellingly of the need for an appropriate level of funding for ME research. I am grateful to you for making this case and am sorry if you feel that I – and perhaps others – are ‘shooting ourselves in the foot’ by expressing such reservations about who is in charge of research. But experience has taught us that bad research is even worse than no research. The efforts of Prof White and the biopsychosocial school have been one of the main factors in reducing investment in biomedical research in recent years. It has taken patients many years – and a lot of energy we could ill afford to spend – to get to the stage where we are finally starting to expose the PACE Trial for the sham that it is. We cannot afford for the same thing to happen again.

 Note: I’ve been asked to include details of ‘unsigning’ in case you previously signed the MEGA petition and wish to un-sign pending further information about the study. I covered it here

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 Continue reading “The Light of Day”