Despite getting what appeared on the surface to be a good sleep last night, I am really tired today. All my recent adventures catching up with me no doubt.
Today I want to talk a bit about some of the controversy and misunderstanding surrounding CFS/ME, particularly in regard to exercise, Graded Exercise Therapy (GET) and Cognitive Behavioural Therapy (CBT).
A lot of the controversy in the UK has stemmed from a piece of research published in the Lancet in 2011 called ‘The PACE Trial’. “Ooh, The Lancet!” I hear you say, “It must have been peer reviewed and respectable” I hear you say….. well hold on, you might be surprised.
The (very simplified) conclusions of the Trial were basically that if you have CFS/ME you just need to get your body moving (exercise) and see a shrink to talk you out of your unhelpful beliefs and that if you did, you would have a 60% chance of improving with a 20% chance of full recovery… but the scientists refused to issue their data and something was whiffy in the state of Denmark!
The gut feeling of people who actually have CFS/ME was that this research didn’t ring true with their lived experience, for example I know that if I undertake any activity, never mind exercise, pretty much all of my symptoms go through the roof. But the shrinks argued that we had just let ourselves get ‘too deconditioned’ or that we had ‘unhelpful’ beliefs and feelings about exercise and that if only we would build up slowly enough, we would be fine. And that if we weren’t fine we were just doing it wrong or not trying hard enough. And if we were previously gym bunnies or enjoyed the outdoors or, god forbid, had been athletes, then we were just ‘outliers’ in the experiment.
So a years long legal battle under the freedom of information act began to try to get the data but in the meantime this idea took hold in the media and in some sections of healthcare (who have a vested interest $$$, cough cough, psychiatry cough, big pharma, cough). Not least because the guy who was on the government committee who recommended the approach to the NHS was actually the same guy who conducted the research and wrote the paper (to the tune of £5m in his pocket). He made his career on it… conflict of interest much?
The ideas presented have gone on to influence treatments which have caused sufferers to be disbelieved, treated poorly and made more ill. Parents of children with CFS/ME have been accused of ‘enabling’ bad behaviour and threatened with having their children removed and some severe patients (who make up around 25% of us) have even died as a result. I am not joking, you can Google this.
Now, I am speaking from personal experience as someone who has been sent on a “Lifestyle Management Course” at the Thistle Foundation as a ‘treatment’ and sent for shrinkage at a specialist CFS/ME clinic, here in Edinburgh, at the Astley Ainslie. I can tell you that the former is extremely patronising and unhelpful (I am talking primary school stuff about eating fruit and veg and going to bed on time and that sort of thing) and the latter, whilst helping me come to terms with my situation (for which I am grateful) didn’t offer any real treatment of the disease at all.
Meanwhile in the USA, some seriously hardcore scientists and very respected universities and hospitals like Stanford, Columbia, Johns Hopkins and the Mayo Clinic were finding unusual and concerning physiological patterns in the immune systems and mitochondria of CFS/ME patients and gene expressions were being identified to explain why this runs in families. Pretty much no one over there (or in other respected studies like the Norwegian one) were doubting that this is a physical disease just like Lupus or MS….. but there is a lot of money tied up in protecting this GET and CBT idea in the UK.
Fast forward to last year and an Australian called Alem Matthees won a court case which ordered the data released after the university (where the lead researcher worked) repeatedly denied FIA requests on the grounds that they were “vexatious, a threat to patient anonymity and that they had received death threats.”
What has been discovered about the PACE Trial since is horrifying and testifies to our lived experiences. I would go so far as to say that the people involved should be prosecuted for the mistreatment it has caused but the bigger problem for me personally is that it’s much harder to fight an idea.
A stupid, implanted, ingrained, prejudiced idea that too many people in the UK believe because it makes better ‘news’ than the truth. They have a six-year head start and not enough people are listening to the debunking of the trial and the new research, least of all the NHS and the Doctors within it that move at a snail’s pace when it comes to taking on board anything new.
Actual quote from my actual doctor; “I am not going to read every crazy thing you bring me off the internet”. But I don’t want to get started on this. That’s story is for another day.
I don’t want to bore you to death with loads of technical stuff, so I will try to keep it brief but here are the main findings from the data release. There were 641 participants btw.
Before the study started, like with most experiments, the scientists set standards for the outcomes like “if we see x or y being reported, it means recovery”. It’s just simple good science, like in school when you start out with your hypothesis, your aim, you experiment etc. but only on a big expensive scale!
Well, after the experiment started they changed all the measures and definitions when they weren’t getting the results they wanted.
You might think it’s not such a big deal BUT because they changed it mid experiment and by so much, someone could actually have got worse but be reported to have ‘recovered’. For example, the physical function measure became so low that it was considered an average 70-80 year old could meet it.
Another thing, and this is big, was that the only evidence the researchers used that patients were recovering was the patients’ own questionnaires. They couldn’t find ANY significant improvements based objective measures, for example how many patients got back to work or how many came off benefits, or on levels of fitness such as how far they could walk without pain and that kind of thing.
The problem with the questionnaires being the only real evidence is this; it was kind of like brainwashing. Imagine for a second; you go in and are asked to self-rate symptoms. Then, you are browbeaten over a year of treatment to pay less attention to symptoms because your beliefs are ‘unhelpful’ to your recovery. Then you’re asked to rate the symptoms again. What do you think would happen?
We all know that if you’re told something enough you might start to conform to the idea, even if it doesn’t feel true and that’s not to mention the other factors like not wanting to fail, or to be judged etc. There are so many experiments to prove this happens it’s not even funny! I saw one on Duck Quacks Don’t Echo just recently where people were sitting in a room being asked which line on a board was longer and even though there was an obvious right answer, the test subject doubted themselves and went with the answer of everyone else in the room!
I’m telling you, I stuck to my guns about how I was feeling (no one tells me what to think) and I was treated like a hypochondriac paraiah!
A lot of the participants and other patients tried to bring this to light: They wrote blogs, contacted the press, they submitted carefully worded critiques back to The Lancet and other medical journals. They even published their own papers in peer-reviewed scientific journals. But to no avail. They were called crazy crusaders and hijackers of the debate, such has been the refusal of the British Establishment to consider that they might have got it wrong.
A lecturer from the University of Berkeley in California, David Tuller had even spent his own time and money reviewing the Trial and totally trashed it in a famous Virology Blog. You can read it here (http://www.virology.ws/2015/10/21/trial-by-error-i/).
Then some other scientists wrote an open letter to The Lancet about how flawed and embarrassing to the scientific community it was and one by one the voices started to build against this Trial and its rotten data and outcomes.
Now the data has been reanalysed and the results are shocking. It basically proves that GET and CBT do not work in any statistically scientifically significant way;
The original university that did the study (Queen Mary University of London) tried to smooth things over by reanalysing the data using the original measures (damage control if you ask me) and it showed that only 20 percent of patients improved with CBT or GET in addition to medical care, not 60 percent as claimed originally. And even that might be misleading, because the reanalysis also found that 10 percent of participants improved after receiving only standard medical care. That means that 10 percent in each of the treatment groups might have improved anyway, leaving only 10 percent who were helped by GET or CBT.
Finally, the claim that 22 percent of patients who received either treatment made a full recovery was analysed independently by statisticians Philip Stark of the University of California, Berkeley, and Bruce Levin of Columbia University. Their analysis showed that had the researchers stuck to their original standards, only 4.4 percent of the GET patients and 6.8 percent of the CBT patients would have ‘qualified’ as having recovered, along with 3.1 percent of control patients that received neither therapy.
Believe it or not the British Shrinkage Establishment are STILL defending the study and that is evident in what happened last week with the Joint Commissioning Board for Mental Health (England) and why I was so angry and upset. But there is copious evidence that they are wrong and all they are doing is damaging the chances of finding a real treatment in my lifetime.
You can, of course, do your own research into what I’ve said here but this piece should give you plenty to go on the next time some ignorant twat tells you that CFS/ME is all the head. We need more friends and supporters out there…
My piece is based on several articles that I have read over time but I want to specifically credit Julie Rehmeyer who wrote a great piece on the history of the subject for STAT news in September last year called “How bad science misled CFS patients”. It has lots of great references and links which are very useful.