PACE Trial: People with ME

Debate between Carol Monaghan and Rachael Maskell

Tuesday 20th February 2018 Westminster Hall

[Carol Monaghan]

I thank the hon. Gentleman for his intervention. It is typical, because the PACE trial had such publicity and was lauded by many as the answer. One participant in the original trial has contacted me:

“I was determined to be a part of the...trial because I wanted to get better—so if this ‘treatment’ could make me better I wanted to give it the chance to do so. I was assigned Graded Exercise Therapy. It never occurred to me that it would actually make me more ill. Nor did it occur to me that decline would not be documented, and that despite patients not recovering (or in some cases worsening), they would publish that the treatment was successful...It was stressed that I would only get better if I tried harder, and even though the graded exercise was clearly making me worse, my struggle and pain was dismissed.”

[Rachael Maskell (York Central) (Lab/Co-op)]

As a former physiotherapist, I recognise that all therapeutic interventions must be patient-led—led by people with the lived experience. Does the hon. Lady agree?

[Carol Monaghan]

Absolutely. In fact, I will be calling for the patient voice to be heard in any treatments.

Calls to publish the raw data—basic protocol in good research—were ignored. Queen Mary University spent an estimated £200,000 on keeping the data hidden. Finally, after a long battle, patients won a court order to force the PACE authors to release the data. It was discovered that the authors had altered the way in which they measured improvement and recovery, to increase the apparent benefit of the therapies. Re-analysis showed that the improvement rate fell from 60% to 21% and the recovery rate fell from 22% to just 7%.

The method of patient reporting has also been questioned. As one participant says:

“After repeatedly being asked how severe...my symptoms were—in the context of…it’s just me not trying hard enough...I started to feel like I had to put a...positive spin on my...answers. I could not be honest about just how bad it was, as that would...tell the doctors I wasn’t trying and I wasn’t being positive enough. When I was completing questionnaires...I remember second guessing myself and thinking for every answer: ‘Is it really that bad? Am I just not looking at things positively enough?’”