PACE Trial: People with ME

John Howell Excerpts

Tuesday 20th February 2018 Westminster Hall

[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?’”

[John Howell (Henley) (Con)]

I thank the hon. Lady for securing this debate. The PACE trials have been roundly condemned by many scientists as being totally inappropriate. Does she have a feel for what an appropriate trial might have found?

[Carol Monaghan]

Yes. I will come on to how an appropriate trial could be done. First, I will mention the self-reporting that was a part of the trial. Questionnaires provided the data and measures of success. There were no physiological or scientific measurements. For patients the damage was done. I am a science teacher by profession and I always told my pupils that there are a number of stages to any scientific investigation: “Start with a hypothesis. Decide how you will test this theory, what measurements you will make, how you will record your results and how you will use these results to draw your conclusions. Those conclusions, which might be different from the original hypothesis, must be based on the evidence you have gathered.”

That did not happen in the PACE trial, which relied on patient self-reporting, rather than measurable physiological parameters. Furthermore, when the results were not as expected, rather than revise the original hypothesis, the investigators simply changed the success criteria. Thus patients participating in GET who had deteriorated during the study were considered recovered.

There are, of course, ways of measuring the physiological impact of exercise. The two-day cardiopulmonary exercise test can objectively measure post-exertional malaise. We know that a person with ME can perform adequately—sometimes even well—on the first day, but can have greatly reduced cardiopulmonary function on the second. The test requires the participant to exercise on a static bicycle, and allows data on oxygen consumption, workload and gas exchange to be measured. Two identical tests, separated by 24 hours, must be carried out to properly measure the impact of exercise. Results from a single test could be interpreted as a lack of fitness. Two tests change that to something quite different. A healthy person will perform better the second time; an ME sufferer will most likely be worse.

Of course, the failure of the PACE trial to do that could simply be put down to bad science, but unfortunately I believe that there is far more to it. One wonders why the DWP would fund such a trial, unless it was seen as a way of removing people from long-term benefits and reducing the welfare bill.