Diary Day 116: Will Publishing The CFSME PACE Trial Data Topple The NHS?

I stand alongside many bloggers, clinicians, academics and interested parties who have been calling for the publication of the PACE trial data.

I am delighted that the last few weeks has seen a legal ‘win’ for all those people and more.

One question predominates: “Why all the fuss about releasing the data anyway? If it’s a valid research study, it should stand up to outside scrutiny”

The NHS Partners

Well, Queen Mary University Of London and Kings College, who jointly own the rights to the data and in Queen Mary’s case did the statistical analysis of the results of the participants in the PACE trial, have a vested interest in keeping the data out of public reach.

In many ways I understand their reasons for denial of access, I’ve been a researcher myself and data confidentiality is a vital ethical consideration but there’s a ‘however’ in this.

The PACE trial came about because of a 5 year study which was funded partly by the UK Government, the Department for Work and Pensions, nonetheless. Those are the guys who make decisions about people’s fitness to work, in case you didn’t know that already.

The other partners in the research budget were UK Medical Research Council, Department of Health and the Scottish Chief Scientist’s Office. I’m not reeling off this list for arbitrary reasons, it’s important. 

I’ve blogged about the dynamics of influence and power here before, follow that link.

Will publication of the PACE trial results bring down the NHS? 

Participants were recruited into the trial from 3 clinical settings; in Oxford, Edinburgh and 3 London hospitals. These are large organisations with millions of pounds of potential research budgets at their disposal and professional reputations that reach far beyond the PACE trial itself.

They are organisations who work in partnership with the NHS in the carrying out and delivery of research findings into health care and are, in that respect, hugely influential in the cogs and whirrings of the largest state run health care organisation in the world.

They are hugely influential in the lives of patients like myself too.

I’ve blogged about my experience of working in the NHS and how my recent, additional experience of being a CFSME patient has clouded, coloured and changed the view of a profession I previously had utmost respect for.

The NHS toppling off the pedestal it was placed on has been compounded by the utter cock up of a research study that would appear to have influenced my ‘care’ – PACE.

I don’t think it is an exaggeration to suggest that with the publication of the results, we are facing a situation where the NHS edifice crumbles as a result…

Inside the NHS are entrenched links between care delivery, the government and partnership organisations. It is, in fact, no surprise to me whatsoever that the list of people who paid for the PACE trial and those who were involved with its delivery is so vast.

These people are called stakeholders, using NHS lingo. They collaborate, inform, respond to and drive initiatives that the NHS implements. The NHS does not stand on its own, its partners in running it are hugely important too.

Picture this scenario: the PACE trial data is released and at that point it is available to the person who made the first Freedom of Information request. After that we can reasonably assume the entire data set will be made public.

Holes or should we say ‘large questions’ about the research study design have already been unveiled by people like Tom Kindlon and that’s without looking at the data.

WITH the data, what more is going to be found out?

Will it reveal that holes in the raw data exist also?

Will it support the findings of people like Tom Kindlon who worked very hard indeed to bring those holes to light?

If that scenario happens, what will that mean for: 

• UK Medical Research Council
• Department of Health
• the Scottish Chief Scientist’s Office
• The Department for Work and Pensions
• The Wolfson Institute
• Queen Mary University
• 3 London hospitals
• 1 Oxford hospital
• 1 Edinburgh hospital
• The ethics committee who passed the research protocol?

Look at that list…..take one long hard look. They worked together, not alone. They were one body, not separate. They were the partners that brough the PACE trial to its conclusion and the NHS worked on their recommendations.

If the scenario plays out that the PACE trial data had so many holes as to make it as leaky as the Titanic after it struck the iceberg, how could it be that not one of those NHS partners noticed?

I feel that it’s not a credible argument that they didn’t notice. But let’s assume that they may not have done.

If they didn’t, why not. That’s exactly what they are trained and employed to do – to notice those gaps, those holes, those issues that may render the PACE trial invalid.

And what does that say about the NHS research base also? 

The publication of these results is as huge in implication for the NHS research partners as it has been for the CFSME patients who have been suffering from the one-size-fits-all care package as a result of the research.

If we are to believe that no-one noticed, what does that say about other research studies that are also the basis of patient care?

In the NHS effective research = effective and safe care

The implications of PACE are enormous.

I for one am watching QMUL’s response to the legal forcing of their hand and will be here to talk about what happens if the worst happens; if it shows once and for all that the PACE trial was corrupt from start to finish.

Copyright Lindy 2016.