BMJ: Pressure grows on Lancet to review “flawed” PACE trial

There were objections to the PACE trial right from the beginning because there had already been studies done in CBT and GET and they were all flawed. We believed that the trial was being rigged right from the start to give the answer they wanted.

I can't remember the details now, but there had been a big meeting where "independent scientists" were meant to decide where research should be headed. One of these was so independent he had published with Wessley, but moving on...

We though that the money was going to go to biomedical research but then the PACE trial was announced.

I truly believed that it was going to show overwhelmingly good results. When it came out I was scared to look and was dumbfounded that the results claimed were so bad.

 

"From ME Essential - July 2004

MEA calls for PACE trial to be scrapped
A number of criticisms concerning the overall value of the PACE trial and the way in which it is going to be carried out have now been made by the ME/CFS patient community. The ME Association believes that many of these criticisms are valid. However, we believe that some are not.

The position of The ME Association is as follows:
We fully agree that research into the use of pacing as a form of management is worthy of further research. However, we believe that the money being allocated to the PACE trial is a scandalous way of prioritising the very limited research funding that the MRC have decided to make available for ME/CFS - especially when no money whatsoever has so far been awarded for research into the underlying physical cause of the illness or for pharmacological approaches aimed at either symptomatic relief or possible disease mechanisms. We therefore believe that work on this trial should be brought to an immediate close and that the money should be held in reserve for research that is likely to be of real benefit to people with ME/CFS."

pdf here vvv

 

New response entitled "No Differences at Long Term Follow-up", https://www.bmj.com/content/362/bmj.k3621/rr-8 - very short so I'm not quoting any of it here.

 

From that same pdf (my highlighting):

 

Thanks for that old magazine issue information. Bit disappointing to see MEA true to form accepting of broadest criteria as a good starting point. That was fraught with risk as obviously it’s the psychiatrists favourite for a reason. I was reading a Peter white paper where he referenced that MEA opposition and that article he was bvery aware of, from onset, dismissively as usual. He also talked of how important getting arme and their CEO deeply involved was important

 

There was a lot MEA did good on as well though.

 

From the perspective of the people who think they are delivering an effective treatment when manipulating the patient's judgement of their health status and expectations, it is not problematic that any other treatment that aims to do the same can obtain similar results. To them it's just a confirmation of the idea that psychogenic illness can be treated by manipulating the psyche. They think a placebo is a useful treatment for CFS.

I think this explains why CBT/GET people seem to be accepting of LP.

It's important to stress that when we weigh the evidence they are successfully treating patients versus the evidence they are fooling themselves by confusing placebo with treatment effect, the latter carries more weight. In studies published so far, the treatment effect on outcomes decreases as reliability of the measurement increases. In a double blind placebo controlled study, CBT had no effect https://www.ncbi.nlm.nih.gov/pubmed/8430715

 

Such treatments are good and fine for people who genuinely do have unhelpful beliefs. The huge problem is applying those treatments to people whose illnesses are nothing to do with having unhelpful beliefs.

 

Yes. If patients genuinely had beliefs that got in the way of getting better, changing those beliefs would be the right thing to do. But they haven't proven that this is the case. Instead they set out to treat patients and then viewed a placebo response as evidence that patients had unhelpful beliefs and that these could be treated by belief modification.

Similarly, campaigning against research is bad if the research is good, but it's good if the research is bad and has a negative impact on people.

 

And thereby saw it as evidence that the root cause of the illness could be treated.

 

With trials of some conditions, maybe TMJ and IBS for example, one might have to depend on subjective measures. However ME/CFS affects levels of physical activity and employment. The PACE team are well aware of the latter from their insurance work, the NHS Plus document on employment they were all involved in, etc. Claiming success solely on subjective measures is less justified in this context.

 

FWIW, I got this banner ad again today above Sharpe's response; but only one time.

 

interesting event:
6th World Conference on Research Integrity (WCRI) to be held on June 2-5, 2019 in Hong Kong.
The conference is now a biennial event, and the University of Hong Kong and RMIT University in Melbourne, Australia are proud to co-organize the next world conference.

RMIT do ME/CFS research. Only did a quick search and found a couple from Psychologist Melinda Jackson (but at least they have objective measures):
https://www.researchgate.net/public...gic_EncephalomyelitisChronic_Fatigue_Syndrome
https://www.researchgate.net/public...tigue_SyndromeMyalgic_Encephalomyelitis_CFSME

no one from RMIT Uni Melbourne seems to have signed the letter(?)
@Simone @dave30th

 

I've often wondered if in their clinics they might be defining CFS broadly and so treating a lot of people they say have CFS with CBT and GET and getting decent results, because a lot of those have idiopathic fatigue and/or undiagnosed depressive or anxiety disorders and actually benefit from CBT and GET.

 

From what I can see there is no reason to be that generous. Listening to and communicating with these people I am pretty sure they fail to understand that patients say they are better because they think its rude not too. Some also say they are better to get shot of a doctor who annoys them. Others say they are better, but with a few caveats, in the hope that they will be able to perpetuate a relationship with a doctor they find comforting. Whatever the reason, most patients, at least in the UK, say they are better as a default. They believe they are getting 'free treatment' so don't want to rock the boat. You have to deliberately avoid any suggestion that you are expecting them to be better to have any hope of getting them to be honest and say they are not.

The problem is that a lot of doctors never learn that patients are in the business of fooling doctors just as much as doctors are in the business of fooling patients.

 

When one looks at the loose entry criteria for PACE and you look at the figures (the real ones, not the hyped), I think PACE demonstrated CBT & GET don't work very well for anyone.

 

I had wondered that but the results from the clinics were worse than in the PACE trial. The 2017 paper included employment data. Barts was one of the clinics in the 2013 study.

 

well I was just trying to provide them with a plausible out. I didn't necessarily know if it was in fact the case.

 

thanks for providing that data. I'd forgotten about the real-world results.

 

I was sure I'd never seen that 2017 paper, but I just found posts where I was commenting on it. Thanks for posting @Dolphin - just reading some of your posts where you pulled out lots of interesting stuff.