By David Tuller, DrPH
On February 20th, Carol Monaghan, a member of Parliament from the Scottish National Party, led an extraordinary debate in the House of Commons about the ethical and methodological failings of the PACE trial. The debate included discussion of the debilitating nature of the illness, the conflicts of interests of the PACE authors, the study’s unfortunate reliance on subjective outcomes, the unacceptable outcome-switching that juiced the reported findings, the hundreds of thousands of pounds spent by Queen Mary University of London to avoid the release of raw data, and the trial’s “devastating” impact on patients.
One colleague asked MP Monaghan, a science teacher by profession, about the conduct of the PACE trial and the “cover-up” of the results promised in the protocol. Here’s how she responded: “I think that when the full details of the trial become known, it will be considered one of the biggest medical scandals of the 21st century.” Not surprisingly, the overall debate and that statement in particular heartened the patient community and provided hope that the apparent power of the CBT/GET ideological brigades to shape the PACE narrative is on the wane.
Professor Michael Sharpe, one of the leading lights of those brigades, didn’t seem too happy about the debate. Afterward, he tried to engage MP Monaghan with what can only be described as “PACE-splaining.” In a patronizing tweet, he asked her if she’d actually read the study. “I shall be very happy to send you a copy,” he assured her.
Here’s a Q-and-A I recently conducted with MP Monaghan via e-mail:
What first got you interested in the issue of ME/CFS? Did you have a personal or family connection to the illness?
During my first election campaign in 2015, I visited a constituent at home who had been living with ME for over 30 years. I knew very little about ME and I considered it to be a condition that simply made a person tired. I suppose this is typical; unless an individual has personal experience of ME, it remains very much an unknown condition.
Over the next few years I was contacted by a number of constituents who were living with ME. The thing that struck me most was the lack of support available- the main carer is often an elderly parent and state support is often minimal.
Given the influence of the PACE trial and the reputations of the investigators, what helped you decide that it was a problem?
It was another constituent with ME who persuaded me to look into the PACE trial. Although he had worked in the City and had substantial private health insurance, his insurance company would not pay out because he was unable to complete a program of GET, as recommended by PACE. He asked me, as a scientist, to examine the evidence. I was astounded by what I read about PACE and about the research methods used.
You have referred to it as “one of the biggest medical scandals of the 21st century.” What do you mean by that? Do you think it would be fair to call it one of the biggest medical scandals of the millennium, even though the millennium is less than 20 years old? 🙂
The PACE trial started from an assumption that ME is a psychological condition and this assumption affected all aspects of the research. In science it is fine to start with an assumption but when the evidence doesn’t match the original hypothesis, it must be revised. In PACE the evidence should have forced a rethink of the original hypothesis. The failure to do this has had serious implications for those living with ME. I do believe the trial is a medical scandal; how big a scandal is probably for society to decide.
Do you think this is a case of research misconduct, or is it a case of reasonable differences of opinion?
I believe this has been a very poorly conducted piece of research by some of the most eminent psychologists in the world. It is not for me to say whether or not misconduct has taken place, but I would say that had this been dreamt up and carried out by junior researchers, many more questions would have arisen regarding the methods used and the data gathered.
What aspects of the PACE trial do you find most troubling?
The self-reporting of improvements was particularly troubling. I have been contacted by a number of participants from the original trial. They describe being pressurised to be more positive about their progress than they felt was true. Some describe giving more positive responses to the questions because they didn’t want to let people down, or even because they were so determined to get better that they felt being positive would help. Self-reporting has clearly caused difficulties in PACE.
Why do you think the U.K. academic and medical establishment has refused to acknowledge the self-evident problems with the research?
The trial authors are well-regarded and influential and are, without doubt, experts in their field. Because of this, their results were accepted without question, and The Lancet swiftly published the paper. Because of the influence of the authors, any attempt to question the trial has quickly been silenced. This is continuing to cause difficulties for medical professionals treating people with ME. Whilst the advice given is not the most effective for ME treatment, until there is a different recommended treatment, medical professionals have little to which to refer.
The investigators promised in their protocol to adhere to the Declaration of Helsinki. But then they ignored Helsinki’s requirement that researchers inform prospective subjects of “any possible conflicts of interest.” They failed to include any information in consent forms or other documents provided to subjects about their extensive “possible conflicts of interest.” I have pointed this out to the journals involved but they have ignored this issue. Do you find that problematic?
Of course this is a problem, and this particular point was highlighted during the debate in Westminster. The conflict of interests are troubling, perhaps even sinister.
What was your goal for the parliamentary debate?
The initial intention was simply a starting point to raise awareness. I didn’t expect to secure a commitment to a complete overhaul of treatment methods. However there has been some positive press response as a result of this and I will be pushing for a wider debate in Parliament to keep this issue alive.
What did you think about the response from the government in the debate to the concerns raised about PACE?
The government’s response was predictable and provided no new information. Unfortunately it demonstrated the complete lack of understanding of both the condition and the difficulties with the PACE trial. It is clear that there is much work still to be done.
What was your assessment overall on how the debate went?
I was pleased with the level of support from fellow MPs from every party, with the notable exception of one who tried to make a partisan political point. Many who attended are keen to participate in a longer debate and I will be applying for this debate in the next few months.
What is the next step? Is there a quick way to make sure that no one further gets prescribed treatments that are potentially harmful?
I am currently meeting with patient groups and ME charities to discuss how best to progress. I have a number of MPs on board who are equally keen to see positive development in treatment methods. NICE guidelines are currently under review. We hope to apply enough pressure that patients’ views and the views of experts in the field are considered in the drafting of the new guidelines.
Maureen Bivard says
As a â€œWeegieâ€(ie Glaswegian)Im so proud that a local MP took up the challenge to bring the PACE Trial injustice to Westminster.But now to connect up with David Tuller must surely be THE Dream Team for every PWME.Thank you both for seeing the trial for the fiasco it was,at the expense of people like me ill since 1991,bedridden and still waiting for justice let alone a cure.
(I must of course admit to the conflict of interest in that Carols fellow MP,Alison Thewliss gave little old me a mention….bit of Weegie wit there)
Thank you both SO much and never,never,never give up.
Ken Wyke says
M E is a ticking time bomb of which the powers that be are choosing to ignore. As always, money dictates the situation. Insurance companies, refusing any recognition and denying sufferers much needed pay out.
The Work and Pensions Department and NHS, both turning a blind eye in not taking responsibility for this insidious and debilitating illness.
In the future, when ME is fully recognised and treated, those who scoffed ,”Yuppy Flu, Malingerers”
may feel shame.
“Unrest” the documentary film by Jennifer Brea ,should get wider showing.
We have to recognise and acknowledge that ME is real and devastates lives.