I was ready to crash when I came home on Friday. It had been a busy week of starting a new job and I was ready to celebrate by slowly sinking into the sofa with my feet up with a cup of redbush!
I was tipped off that Twitter was about to get lively and even for 5pm on a Friday evening it certainly did with possibly the biggest ME breaking news! After years of wrangling, suffering, fall out, cover up and hundreds of thousands of pounds of public money, the hotly contested PACE trial was to finally be put under the microscope!
My discovery of GET and PACE
In Sept 2013 I suffered a major ME relapse. It was almost twenty years since my first diagnosis of ME so I was keen to learn what new treatment options there were. The options were mind-boggling and ranged from the pure bonkers to the extortionately expensive!
I tried to keep an open mind about all ‘therapeutic techniques’ and I decided to restrict options to ‘cheap/affordable’ and ‘least likely to cause extra harm.’
It seemed like NICE (National Institute for Health & Care Excellence) guidelines would be a good, safe place to start. This is where I first came across the term Graded Exercise Therapy (GET). It sounded perfect for me. I’ve always loved sport and physical activity and getting better wasn’t going to be enough for me, I wanted to get back to physical activity.
If it wasn’t for a trusted friend who warned me about the great dangers involved in GET, that would have been the path I would have taken and I dread to think of the consequences. She had gone from ‘mild’ to ‘severe’ from GET and years later is still housebound with ME, and only able to leave the house once or twice a month in a wheelchair.
I researched further and it turned out she was far from alone and GET quickly slipped from the top of my option list and I chose a safer route of diet and pacing instead.
NB Pacing is about managing one’s own energy levels and involves lots of rest and shouldn’t be confused with the beleaguered PACE study!- Pacing, graded Activity, and Cognitive behaviour therapy; a randomised Evaluation)
As I became more connected to others with ME on Twitter I became shocked at how many reported becoming far worse and often wheelchair/housebound after taking GET. This wasn’t just unfortunate it was becoming scandalous. (Listen to BBC Radio Scotland phone in here for patient experiences of GET) How could GP’s be recommending something that had the potential for doing such harm?
The answer only pointed to a wider controversy. CBT and GET encourage patients to change their illness beliefs and gradually increase their activities. It has long courted controversy as an effective ‘treatment.’ Dr Ian Gibson, former MP and prominent campaigner for MEcfs raised the shortcomings of this approach in a judicial review of NICE in 2007. His witness statement reads:
“The NICE guidelines give the false impression, to doctors, politicians, and the MRC, that effective treatments are available for ME patients. NICE would do better honestly to admit that their core therapy recommendations [of GET/CBT] are not evidence-based, and to use this admission as the starting point for an adequately funded search for a cure.”*
However, despite the misgivings from many prominent scientists, ME charities and patient advocates recruitment for a £5 million PACE trial, part funded by the DWP was already underway and finally published in the Lancet in 2011. The results raised more questions than it addressed. In a nutshell, the selection of subjects, methodology, statistics and outcome measures, impartiality and conflict of interests have all been questioned, not just by people within the ME community but by other eminent researchers and journalists. (For detailed analysis click here for David Tuller’s excellent Virology blog)
The level of dubious questions that surrounded the PACE trail combined with the reports of harm that GET was causing had left patients in fear, confusion and were frustrated to say the least. Biomedical science is already starting to demonstrate why activity can be harmful for people with ME. (E.g Keller et al)
Myself, like many others weren’t prepared to take the risk and Doctors had little else to offer. PACE was therefore already discredited in patients eyes unless the data was made available for further scrutiny. It seemed the only logical solution to restore trust. The public, ME patients and science had a right to know if the study claims were valid and 12,000 of them signed a petition asking for the data to be released
However, requests were repeatedly rejected and patients legitimate questions and concerns (including Freedom of Information requests and parliamentary questions) were considered as vexatious harassment and patients were discredited. QMUL (Queen Mary University London) spent a staggering £200,000 in legal fees to prevent the release of it’s data, which left everyone asking why?
Maybe QMUL protested too much. It began to attract attention from those with a wider interest in civil liberties and the small, discredited voices of patients were being elevated and amplified by veteran campaigners such as Peter Tatchel.
The controversies surrounding PACE have been getting deeper and more entrenched for years but it felt like change was close. Resignations were being reported and finally, late on a Friday afternoon came the news that the PACE trail data WOULD be released! Hooray!
Optimism for the future
It has been a fantastic few weeks for people with ME. Dr Naviaux’s groundbreaking research into metabolomics could be a real game changer. This alongside the increasing findings of biomedical research could soon render psychological therapies outdated and redundant. There’s much to celebrate and be extremely relieved and thankful for but we mustn’t stop now.
There are many people and organisations that have played a role in getting the PACE trial released. You know who you are and thanks to everyone who has given support, no matter how small. I’m not going to name individuals for fear of missing anyone out but a HUGE special thanks must go to Alem Matthees in winning this case.
BUT – Our children are at risk.
As I’m writing this, a further study is already under way to trial GET on children and adolescents
“to find out more about Graded Exercise Therapy and Activity Management and whether young people think they are “OK” treatments.”
If it was a drug trial, there is no way this would have been allowed to go ahead. It’s totally unacceptable for our children to be used as guinea pigs in this way. Approval for the MAGENTA study (Managed Activity Graded Exercise in Teenagers and Adolescents) was given based on the positive outcomes of the PACE trail. I would like to see it scrapped altogether, but at the very minimum, to put it on hold whilst PACE is being re examined. Please sign the petition to stop trials of graded exercise here
So whilst celebrating one victory I also wanted to flag up the ongoing risk to our children. So lets not celebrate for too long -just yet!
For more details see ME Action Network PACE trial press release
Since writing this post and the release of the data prominent scientists and researchers across all disciplines, alongside patient groups and charities signed an open letter calling for a retraction of the study in March 2017 (click here) The fight for transparency, honesty and ultimately help for people with ME continues!
NICE have also brought forward their plans to review their guidelines in summer 2017 partly due to the to the “new information about the 2011 PACE trial” (click here)
*Gibson I. Witness statement in support of the Judicial Review case of the NICE “CFS/ME” Guideline (CG53) online brought by ME patients:Re: Douglas Fraser & Kevin Short v NICE Case Number: CO/10408/2007.Exclusion code 9.