Saturday, 17 September 2016

The PACE Trial Fiasco (for ME Awareness Hour blog)

This piece was written for the ME Awareness Hour blog, and you can see it in it’s proper home, here.

Hello my lovely loves,

It’s been a bit of a week filled with an odd mixture of happiness and righteous indignation for us spoonies, because the truth is finally starting to come out about the infamous PACE Trial… but it’s also been a long, exhausting road.
Pretty much all ME/CFS sufferers know all too well what the PACE trial is, but in the interest of friends and family who might not, let me break it down for you.

The PACE trial, run by Queen Mary University London (QMUL), was the biggest study ever into ME/CFS, with over 600 participants, looking into different methods used to "treat" ME/CFS. (I put treat in inverted commas because "manage" would be more accurate, as there’s no treatment for ME/CFS as yet.)

The trial looked at specialised medical treatment (SMT) on its own, and SMT with either CBT (Cognitive Behavioural Therapy), GET (Graded Exercise Therapy), or APT (Adaptive Pacing Therapy), and their outcomes were published in the Lancet in 2011. It was publicly funded to the tune of five million pounds, and the results have influenced the medical treatment of ME/CFS sufferers ever since. Before the trial was even finished, the NHS announced it would be using the methods from it to treat patients.
It’s also probably the biggest load of twaddle ever to give ME/CFS sufferers (and decent scientists, statisticians, and medical professionals) a headache.
I think Dr. David Tuller, of the University of California, said it best when he called the study “a piece of crap.” 

(He also wrote a pretty amazing three part article on the whole thing - far better than I could ever hope to produce - so, if you want to go into detail, I suggest checking it out here.)

White et al, of QMUL, had hypothesised that ME/CFS wasn't actually a disease in and of itself, but that people, after suffering an illness, would get stuck into a psychological state where they believed exerting themselves would make them ill, and that the physical symptoms were just the deconditioned state of the body. I don't need to tell you exactly how ridiculous that is to me, particularly given both the research showing that, yes, it is a physical disease, and my personal experience. How physical deconditioning would've given me the hearing of a bat, for example, I have no idea.

When it was published in the Lancet, in 2011, the study purported to have found that CBT and GET were the most effective treatments, where CBT gave an recovery rate of 59% and GET gave an recovery rate of 61%.
This seemed a little strange, as previously the general consensus of sufferers was that CBT and GET either didn’t really do anything, or actually worsened their symptoms; hardly surprising as they’re really designed for dealing with psychological illnesses and physical reconditioning, not for a physical disease that targets your energy reserves.
The media, however, lapped it up, and, yet again, sufferers were forced to see and hear headlines telling us we just had to think positive, exercise more, and ultimately try harder not to be ill.

However, those following the trial quickly realised that not all the results made sense. Participants were deemed ill enough to enter the trial if they scored 65 or under on a well known scale of physical ability, called SF36PF, or Short Form 36 Physical Function Subscale 
(where 0 is highly disabled, and 100 is completely healthy), but, when published in the Lancet, 60 was deemed to be “the normal range”. The participants’s physical health could actually worsen during the trial and they would still be counted as being in the normal range. 

If 60 was “normal” for healthy people, (or "recovered", the term they used later) then why were people who counted up to five points above that allowed to enter the study in the first place? 13% of the people in the trial were counted as recovered in two areas of its tests before the trial even began.
Obviously, that seemed rather odd, so many people asked questions, both in the medical profession and otherwise, and other inconsistencies and bad scientific practices emerged.

The level of recovery had originally been listed as 85 on the scale of physical ability, but was later dropped, with 60 becoming "normal", later implied as "recovery".

Graph and table from Peter Kemp blog, with permission, link below

The participants were given literature halfway through the trial informing them of the usefulness of CBT and GET in treating ME/CFS, and every participant knew which treatment they were receiving, potentially allowing positive bias towards those treatments (not to mention the possibility of a placebo effect taking place).
The sister trial, FINE's results, which was focused on housebound sufferers (who weren't all eligible to take part in the PACE trial due to not being able to attend sessions), were not mentioned. (The participants in the FINE trial found no real difference in their state when using CBT or GET.)

As I said above, the NHS publicly announced which of the treatments it would be using from the trial, halfway through the trial period, which could've influenced the participants even more. (I’ll not go into how bizarre it is to suggest treatments based on a trial that doesn’t include the worst sufferers of the condition.)

The PACE trial leaders did not properly disclose the close consulting and financial links leaders had with insurance companies when gaining consent. This counts as a conflict of interest and participants should have been made aware of this.

According to an article from the ME Association, "The trial was part-funded by the DWP, and was assessing the value of biopsychosocial interventions at the same time as the DWP was using the biopsychosocial model of disability to help justify cuts to disability spending."

All of the data published was based on subjective questions, and, although there were objective tests the trial had originally deemed suitable (walking for a set number of minutes etc), the trial leaders later deemed them to be unsuitable, even though they were the very people who had chosen them in the first place. This occurred after the trial had finished. 

There was a tiny graph published showing an objective step-test in 2015, but it was so small that you couldn't really get any meaningful information from it. It did, however, appear to show GET and CBT doing worse than the other groups. The community asked to see that information in greater detail, and the request was refused as "vexatious".

The community didn't give up. They kept asking, even when their questions were deemed “harassment”, and they themselves were branded “young men, borderline sociopathic or psychopathic”.

In March 2014, a sufferer named Alem Matthees asked to see the PACE trial data under the Freedom of Information Act.
QMUL still refused to publish the data and has spent £200,000 in legal fees to stop the publishing of said data, stating that they were being harassed by "a community whose members are driven to challenge the outcomes of studies with results which do not comport with their beliefs as to the causes and treatment of CFS/ME”. This was because they received so many FOI requests, and that the intent of the community wasn’t to find out the truth, but to be “vexatious”. They also counted “complaints” and “House of Lords debates” as harassment.

Fortunately, last year the Information Commissioner agreed with us, and ruled in favour of Alem Matthews, and the thousands backing him.
Last week? QMUL published some "first protocol” results, although they’ve tried their hardest not to go through with it, and it wasn’t until a tribunal upheld the commissioner’s decision they actually went through with it. 

Frustratingly, it’s still not the raw data we asked for, but even the information they have released shows a two-thirds decrease in improvers.
The CBT improver rate goes down to 20%, the GET to 21%. 

Graph from ME Action's article, link below

Not only that, but because the specialised medical treatment group had 10% improvement, the difference the CBT and GET actually made is as little as 1 in 10. Hardly the "reversal" the trial claimed.

Graph from Peter Kemp blog, with permission, link below

We still don't know the rates for recovery at the rate it was originally held at (80), or the rates of people who found therapies made no difference, or worsened their condition.

I’d like to say to QMUL, and the leaders of the PACE trial, that the whole point of science is to question things in the attempt to find the truth, and that doesn’t stop just because you’re big and we’re little, and you don’t like the questions we’re asking. 

If you didn't like us seeing the inconsistencies in your research, then you should have done the trial without the obvious flaws your fellow scientists have pointed out to you, so that they weren't an issue.
To say that we didn’t want to know the truth for the truth’s sake is absurd and, quite frankly, insulting, because the outcomes of this trial effect us far more than it ever will you.

If standing on one leg and singing the national anthem backwards would cure this horrible, harrowing illness, then I would do it, and I know all the other sufferer’s feel the same way.

I even think psychological tools like CBT have some uses - in helping sufferer’s to deal with their situation, if not actually doing anything to cure the original, physical problem - and I use them on a regular basis to help me cope with my illness, so it can hardly be said that I’m part of some bizarre conspiracy against psychologists or their tools.

GET I’m less keen on, I’ll admit, but that’s because pushing myself has only ever done me harm while I’ve had this disease, and surveys in the ME/CFS community agree with that view. Adaptive pacing therapy at least has the flexibility that allows the body to recover between activities.
(I’ve said before, and will doubtless say again, the only thing that’s worked for me is allowing myself to see ME/CFS for what it is - a physical illness - and resting accordingly. As soon as I seriously committed to proper rest, without stimuli or stress, I started to see improvement, and my regime of rest, careful nutrition and pacing has seen me come on amazingly in the last two years.)

I believe that the PACE trial has been a really harmful study for the sufferers of ME/CFS, leading us to ineffective treatments and further stigma. The continuation of trials using GET is ridiculous, and, what's more, potentially dangerous to sufferers.

This study is the worst kind of science, and noticing flaws does not mean we are sociopaths or psychopaths. Neither does it mean we're close-minded members of a group that's only interested in our own views.
If you're able to publicly recommend therapies that are useless, or potentially harmful to patients, based on a flawed study to further support your own opinions on ME/CFS, then I'd suggest you take a look in the mirror, because, after all, aren't psychologists meant to know all about Projecting?

If you’d like to take a look at the sources used in this piece, please head on over to the links below. 

Dr David Tuller’s three part article on PACE, October 2015

Article from ME Association: "Break Through on PACE Trial", 19th Aug 2016

Article from ME Action: "QMUL releases the PACE data”, 9th Sep 2016

Retraction Watch: UK Tribunal orders release of data from controversial chronic fatigue syndrome study, 17th Aug 2016

Articles (and graphs, with his permission) from Peter Kemp’s blog: "PACE Trial Participants - were they exploited?”, 10th Sep 2016, and “PACE Trial Improvers”, 12th Sep 2016

Document on Queen Mary University’s arguments regarding the application of section 14 to the request, available here

Wednesday, 7 September 2016

That time I was in The Telegraph

Hello again,

Just a brief note to, firstly, say that I wrote an article that was in the Telegraph this week. Link here. It's entirely possible you already know, either because that's what led you here, or, more likely, because I told everyone I know.
It's a bit strange trying to pare down your situation to 700 words, but I'm pretty pleased with the results, even if the editing took out my favourite line!
I do feel I need to say, however, that I originally made sure to say outright that mental illnesses are real illnesses. It's just that my illness is physical.
The final edit still implied that view, but I think it's important to reiterate that.
I didn't have space to go into the importance of psychological tools in managing physical illness, or the psychological symptoms/tag-alongs of the illness (anxiety etc), and, honestly, I was worried it might muddy the waters on my views about ME/CFS.
ME/CFS is physical, we know that and we have proof, but having a chronic illness plays merry hell with your emotional and mental state, and it's important to make sure that side of your recovery or management is supported. I Skype regularly with both a psychologist and a hypnotherapist and I find both of those things immensely helpful. (Plus they're both really nice.)

Secondly, I'd just like to say thank you to all the responses I've had from people. It's been a little overwhelming and I'm not sure I'm going to be able to respond to everyone (I will try, but no promises!), but please believe that it's very much appreciated.
I will also definitely take the medical suggestions under advisement, but I am currently with the Optimum Health Clinic, getting advice from a nutritionist, and under the care of the local NHS ME/CFS clinic, so worry not, I'm not languishing in the way you might think!
The article was the bare bones of my situation, and yes, my situation is worse than others... but better than some! I'm doing well and I have been slowly improving since I first became housebound.

If you want to continue to follow the discussion on the recent research that shows similarities been sufferers' blood and hibernating animals, there's a radio piece on today on BBC Radio Scotland on the Kaye Adams programme. I think it's around 11am but I'm not positive.
They did ask me to join in via phone, but unfortunately the excitement of the article being published (and the payback from writing it in the first place) have meant that I can't be involved. They might quote my article though, so that's pretty exciting.
As far as I'm aware, Dr Shepherd, the medical advisor for the ME Association will be talking, so it's likely to be good.

Until next time, I'm sending you lots of love.


Saturday, 3 September 2016

A Very Special Book

Hello my lovely loves,

Another post! And so soon! I don't know, it feels like so much is happening at the moment that I need to keep you updated regularly or risk writing a post the length of the Odyssey if I try to save it up!
This is another one of my completed secret project announcements though, so it's been on the back burner for a long time.

You may remember that last year, at the beginning of my "You Don't Look Sick" post, I talked about a friend of mine called Nicky Boardman, who blogged about his battle with cancer in the amazing blog Too Upbeat For Cancer.
You may also remember that he sadly lost that battle. All my friends that knew him were pretty cut up about it, and it was particularly heartbreaking knowing that his wife, Kerry, and his young son, Ethan, were left without him.
I kept thinking about all the great memories we had of Nicky that Ethan wouldn't know about and I had a thought. We should find a way to give Ethan these memories.
I spoke about it with my good friend Dale, and he took my little idea and made it into a rather big idea. He said we should make Ethan a book; a book full of Nicky, so that whenever he missed him he could take out the book and look and remember.
So that's what we did.

It's taken over a year to complete it. We created an email address to gather the stories and pictures, and then I (very) slowly created illustrations for the stories, with more as backgrounds and embellishments. It's all themed around the Avengers, as Nicky was a massive fan of all things Marvel (plus, he was a bit of a superhero himself).
Dale did the lion's share of the formatting and looked into printers and papers and bindings and prices. Once we'd found a place to make it we collected money from all the contributors and a few more who'd heard about what we were doing.
We had enough for a book each for Kerry and Ethan and even enough left over for a donation to one of the many charities Kerry fundraises for in Nicky's name.
We got Nicky's brother involved so he and his family could give our gift to Ethan and Kerry and support them if they needed it.

And last week... Kerry and Ethan finally got their books. And we couldn't be prouder.

Thank you, so much, to everyone who contributed, particularly Dale for all his hard work. 
I know you were all happy to do it, even if it was hard to put your own grief aside to do so, and we couldn't have done it without you.
You've done something amazing. And you know what? So have we.


If you want to see more of the illustrations head on over to my illustration blog, here. To support Kerry's sunshine walk, head here.

Monday, 22 August 2016

Tiny Hannah sets off (and other things)

Hello again my lovely loves!

It feels a bit strange to be writing again so soon, but, as I had such a fantastic response to Tiny Hannah, I thought I'd let you know that she's off on her first adventure today.

She going to Edinburgh first, and then on to Derby, and, as you can tell from the photo below, I seem to be a bit nervous about her trip.

Fortunately, she has her Tiny iPhone with her if she gets in a jam.

As I said, the response to the doll, and the video Mum and I made, has been lovely, including a very nice mention from the Conscious Crafties, who wanted to know if I'd be interested in selling Tiny Humans through their website. (Although they, quite wisely, didn't use that slightly questionable wording.)
Unfortunately, due to the sheer amount of time and spoons it takes to create one of these dolls, it's unlikely that I'll creating a business out of it, but I'll show you how to make your own, bit by bit, on here. Perhaps in the future I'll do occasional commissions if someone really, really wants a doll made by me.
In the mean time, if you're keen to support Spoonies (and their carers) who are unable to work full time due to illness or disabilities, you can head on over to Conscious Crafties and check out their pretty impressive online shop. They're also on Facebook and Twitter.

*plans entire Christmas present list*

In other news I had one of my previous posts featured on The Mighty, which made me feel pretty bloody amazing. You can see it, in all it's glory, here. (the Dutch website that featured a translation of the same piece that the mighty chose to run), also just featured my "What not to say to Sick People" post, so that's available here.

You can keep up to date with Tiny Hannah's adventures on the blog, on my Facebook page, or on Twitter.

Saturday, 13 August 2016

Introducing NEW! Tiny Hannah Doll!

Hello my lovely loves!

I’ve been working on this top secret project for a while now as a way to let me be more involved with all my friends lives. 
It’s really difficult to see my friends having weddings and babies and birthdays and not being able to be there for them… so I created a tiny felt version of myself to go in my stead.
Check out the introductory "advert" above! (With an excellent performance from mum.)

Tiny Hannah has teddy bear joints in her arms, bendable wired limbs and magnets in her hands and temples so she can hold and wear magnetic accessories. Basically I got really, really into this project. It took about five lots of magnets to find the right ones, and so many parcels from the Postman to get this done, but I’m super chuffed with how she turned out.

She’ll be available to visit people so let me know if you want her to wing her way to you. She has two weddings booked already, one in a couple of weeks, and one in October, so she’ll need to be around for that, but otherwise she’s got her tiny suitcases packed and is ready roll.

I will ask that if she does visit you that you take care of her. She’s only made of felt, so please don’t pull her around too much, or give her to children or pets. It took an awful long time (and a lot of spoons) for me to make her, and I want to send her all over the place (and ideally do a photo journal of her travels), so please keep her safe.

I’ll keep everyone updated as to Tiny Hannah’s adventures, and do a series of posts explaining how I made her, so you can make your own Tiny Person.

Wednesday, 27 July 2016

A finished Birthday present (includes a GIF)

Hello my lovely loves!

Just a short one today, as I'm recovering from my latest friend visit. This time from my lovely, honorary sis, Catie.
You may remember that Catie is getting married this year, and I won her and her hubby, Ben, a trip to Venice for their honeymoon (hooray!).
Before I knew about that, however, I started making them a cross stitch to commemorate their wedding day, and potentially display on the day if they wished.
Since we can safely say that I now have their wedding present covered, this cross stitch became Catie's birthday present, and I gave it to her during her visit.
It took my just under a year, but I'm really pleased with how it came out (and the neatness of the back!!). If anyone's interested, the pattern was from an excellent etsy shop called Stitchrovia.



Look at how neat this bad boy is!

Tuesday, 28 June 2016

It's not EU, it's me (us)

Hello my lovely loves,

I know that there has been a lot of talk about the EU and Brexit and you've probably heard enough about it last a lifetime, but this blog is partially to allow me to process and talk about my life, and I have been following the referendum with great interest and worry.
(And unfortunately, this is going to be something that effects us for a long time, so you might as well get used to the term Brexit because, as cringeworthy as it is, it’s not going anywhere.)

I'm pretty heartbroken about us leaving the EU. I've never enjoyed change, although I am pretty good at dealing with it regardless, but i think, for me, this type of change has been more difficult than it might otherwise have been. 
Had this referendum been about moving forward in unity and peace, of finding new ways to improve the world, then I might feel differently. But this doesn't feel like a step forwards, only a step back. 
We've chosen to close ourselves off from the world to try and protect ourselves from unifying changes, and choose a nostalgic world view over a wider picture.
Generally, I'm a big fan of nostalgia, I love 50s fashion and antique items of furniture, but I am careful to fully understand the political situations of those periods. I never say I was born in the wrong era, for example, because while I love dressing like I live in the 50s, I would never want to live a society where there was so much social inequality; for women, people of colour, LGBT people and immigrants.
Nostalgia is only good as long as you recognise a period's faults as well as its positives, otherwise it's just stagnation.

I am also very worried for all my friends who have joined us here in the UK, to live and work, and what this result might mean for them. I don't want them to leave, or feel that they're not wanted, not only because they are some of the most amazing people I know, and that they make this country better, but because no one deserves to be shunned for who they are or where they come from.
Although I believe most people who voted for Brexit are not racist or xenophobic, those that are have taken this collective decision as validation for their own foul beliefs, and there have been many reports of aggression and hatred, to and from people of all ages, to immigrants, and people of colour regardless of their nationality and that's horrifying.
This behaviour is completely unacceptable and it breaks my heart to see that a group of people are considering the UK's decision on Brexit as outright encouragement. They believe that 52% of the country agrees with them in every way, and that should anger the Leavers as much as the Remainers.
(I would briefly mention here that all such acts are classed as hate crimes and should be reported as such.)
Being half Bulgarian, and having a Bulgarian surname, doesn't help either. I might have been born here and lived here all my life, but I doubt that would matter too much to the people responsible for these attacks. Especially as I'm on benefits.

Another fairly large part of my worry (and my remain vote) was that I knew that a lot of the laws that protect disabled and sick people like me would be rewritten by the government. 
We currently have EU guidelines for conduct of disabled people, and our own laws have grown and changed alongside the EU's, as you might expect.
Even with these guidelines and protections in place, the UK government has not always abided by them as well as they should have, and has often left those in need to struggle.

Now we've come out of the EU, our entire legal system will be in upheaval as the government decides on huge swaths of laws, likely without going through parliament (there's just too many to do this).
I can't help but think that this is incredibly undemocratic and could lead to some difficult times for certain groups of people in the future, if they're not properly regulated and the changes aren't made transparent to the public.
If not, I will be completely unsurprised if it leaves the most vulnerable, more vulnerable than they already are.
We know now, of course, that any suggestions that were made as to sums of money that might be spent on the NHS, were just that; suggestions, and have now been debunked by both Farage and Iain Duncan-Smith. The other main draw of the Leave campaign was of course to cut down immigration, and that’s been debunked by Daniel Hannan.
Politicians are so very good at making it sound like somethings been promised when it's only been heavily implied (and unfortunately that makes all the difference when it comes to consequences for said politician).

(On a side note, I'm always surprised when anyone other than the rich vote for right wing governments, especially given the respect and dependence we have on the NHS in this country. Everyone always seems so surprised when history repeats itself and they give business and the rich an easy time and come down hard on the health service and the poor and vulnerable.
The whole ethos of the right wing is the priority of capitalism over socialist ideas, business over the welfare state (and, as an extension, the people reliant on it). As despicable as that might sound, that's what, at it's core, right wing politics is based on. That's why most conservatives MPs are from wealthy backgrounds, they've often never had to worry about what would happen if the NHS crumbled, because they can afford private healthcare. They know that the people most likely to do the biggest business and make the most money are those that are already wealthy, so they do everything they can to incentivise them.
Of course not all politicians, or all conservatives are bad, but... these are the facts. People may be in different places on the spectrum, but right wing politics put business first.
If you were wondering why I'm so sure that's what will happen in the event of further cuts and legislation, that's why; an extremely long list of examples through history. That and personal experience.)

There is of course, the domino effect of right wings groups around the world now calling for their own referendums. I've got mixed feelings about this one: I don't want our decision to shatter the EU (and potentially its continental peace) under any circumstances, but, as someone living in Britain, I also hope that we don't have to become too much of a cautionary tale in order to prevent that from happening.
I don't think the EU is perfect, by any means, but it sprung from a noble idea, to keep Europe from war, and I'm sad, embarrassed, and a little ashamed that we've elected to leave that behind.

Provided the EU is able to weather the storm, I actually think Brexit is a good thing for for the rest of the member states. Britain has always kept itself at arms length from the EU and that must be incredibly frustrating, especially when you're trying to get stuff done.
I just hope the decision to leave, and the continued general arseholery from Farage, doesn’t leave the EU with such a sour taste in it’s mouth that it refuses to work with us in the future. There are so many of us that don't want to leave, and I hope they'll remember us in their talks.

As much as I’d like a second referendum (one where people actually vote for what they want to happen rather than using their democratic power for “protest votes” and then being shocked when the thing they voted for happens), I do think it’s very unlikely.
Even if people regret their actions, everyone was given access to the same information, and the same opportunity to vote for their chosen decision, despite the lies that were peddled and the warnings that were given. 
Unless the petition for a second referendum gains more signatures than the 17 million people who voted to leave the EU, holding a second one would be changing the rules retroactively.
There is of course a possibility Brexit can be blocked by parliament; it is only advisory after all. I’m not sure whether it’ll happen, but we can only hope.
We know Nicola Sturgeon plans to fight tooth and nail against leaving the EU, and would rather break the union of the UK and go for Scottish Independence before Brexit happened, but we’ll just have to see what happens.
I wouldn’t blame Scotland, or Northern Ireland, for wanting out of the UK after the appalling display from the politicians in parliament following the referendum result. Maybe if I ask nicely they’ll take me with them.

If there's one thing this whole debacle has taught us, it's that a vote is not a toy or something to be taken lightly.
Whatever your situation, or your politics (and in light of the upcoming presidential election in the US, I'm particularly looking at you, Americans), you should never vote for an outcome (even in protest) that you would not be 100% happy to live with.
People have made that mistake here, assumed that their vote held no power, found that that wasn't true... and now we must all deal with those consequences. 
As I read online recently, votes do have power. That's why so many countries won't allow their people to have them.


p.s. here are a couple of pieces I created post-result, the first in anger, the second in appreciation. It gave me some nasty Payback, but I felt so emotional I just had to draw something. They’re also available as t-shirts, bags, mugs, and stickers on my redbubble page.