I was joined by Kat Gower, Linda Hending, and Steve Topple to record a podcast about the need for a new reporting system to report harms from non-pharmaceutical ‘treatments’. In case you are unfamiliar with ME Foggy Dog’s campaign, you can read all information and find all relevant links here – Shake It Up
I’m well aware that many people are unable to listen to podcasts and so, because it is such an important issue, I have transcribed the podcast episode below (I usually don’t have the energy to transcribe podcasts but have made an exception – payback imminent!)
If you would like to listen to the podcast you can listen to it here – FogPod Episode on Patreon
Welcome to Fog Pod. This episode is about the campaign I’m currently running called Shake It Up. The campaign is asking for a new reporting system to report harms from non pharmaceutical treatments. The campaign includes a petition.
We are asking Sajid Javid and Amanda Pritchard who is the CEO of the NHS, to implement a new reporting system. We’re also asking UK-based MECFS patients and other patient groups to contact their MP or equivalent, depending on where you are around the UK. Patient power, I believe will bring about this change. Because for too long, our complaints to the NHS CCGs and the PALS service have gone unheard. We need change. I recorded the conversation with a few people from the MECFS patient community earlier this week. Enjoy, you’ll hear that about the need for this reporting system through the lived experience of these people. Thank you for listening.
Okay, so I’m now joined by three members of the MECFS patient community in one form or another. I just want them to introduce themselves to you before we get on to the main topic of today.
Okay, hello, everyone. My name is Steve Topple. I’m a journalist and broadcaster. But my relationship with the M.E community began in 2018, when I started reading about the story of PACE trial, and then started writing about it. Ironically, my partner was then later diagnosed with M.E, and we’ve been trying to deal with the situation for really for nearly three years now. So I have both professional and personal interests in the subject. And, yeah, it’s, it’s been one of the most eye opening experiences, delving into the story behind M.E, and what’s gone on, but also living with someone who lives with it has been one of the most eye eye opening experiences of my life, I would have to say, so it’s, yeah, it’s a extremely personal and raw subject for me.
Hi, I’m Kat. I’ve had MECFS for seven years now. And over the seven years, the condition has fluctuated. Currently, I’m in a position where I can work part time, mainly from home. And I’ve recently had a reaction to the COVID vaccine. So I’m also going through that process as well, which has impacted my M.E somewhat.
Hi, I’m Linda Hending. I had first brush with post viral fatigue syndrome in 2001. And I recovered from that. But then with sepsis in 2013, it then made me relapse. And I’ve been an M.E patient since then. I do a lot of work with my local group and work on raising awareness on Twitter and social media.
Right. So today’s topic, for those who are unaware is the campaign that I’m running for the creation of a new system to report harms from non pharmaceutical treatments. It started out as a petition but has now broadened thanks to Kat’s help. And it’s now part of the Shake It Up campaign. It’s a combination of a petition and asking the MECFS long COVID and other patient communities to contact their MPs, or equivalent wherever they live around the UK, asking for support in their creation of this new system. Because having nowhere to report harms is a massive issue for our community. And when the only ‘treatments’ we’re offered, and I’m saying ‘treatments’ with bunny ears around it, the only ‘treatments’ we’re offered for MECFS, and at the moment long COVID, are non pharmaceutical. There seems to be this massive false belief that non pharmaceutical treatments cannot harm patients, which is simply untrue. You just have to look at the comments on the petition to see that there are other conditions outside of MECFS and long COVID that have experienced harms from non pharmaceutical treatments. So this is an issue that needs to be tackled. It’s something that came to the fore really from the nice guideline review. Because too often it was said that there are no reported harms from Graded Exercise Therapy or Cognitive Behavioural Therapy. The reason for that is patients, for more than a decade, have been complaining to the Patient Advice and Liaison Service (PALS), their complaint gets flagged to the medic concerned, they explain themselves and the complaint goes away. The fact that in 2020/2021, NICE saying that there were no reported harms, from Graded Exercise Therapy and Cognitive Behavioural Therapy shows that there is an issue with complaints to the Patient Advice and Liaison service, not being centralised. Complaints are not being collated or counted.
So that’s the starting point. And I would like these three lovely people to answer a couple of questions for me. The first one is have you ever had to report non pharmaceutical harms yourself? Where did you complain to and what were the outcomes?
I haven’t been officially offered anything. So I haven’t officially been told, you know, you need to go to this place to participate in GET or to have CBT. So whilst that isn’t right, you know, and there’s no pathway and I’m stuck in a position where there’s, there’s no how – I haven’t been prescribed, quote, unquote, any kind of damaging, non pharmaceutical treatments, I, there hasn’t been a need to complain.
Your GP has never said ‘you need to exercise’ or anything like that? Because mine has always been on an informal level. I’ve never had Graded Exercise Therapy recommended to me either. But I did have a M.E nerve issue. And the GP basically said, the talking therapies you’re having will help you with that pain, that kind of thing. But I knew that that was absolute claptrap. So I knew that that simply wasn’t the case. But if your GP had said ‘go and increase your activity levels’, would you have felt comfortable complaining about that or not?
Okay, so that’s interesting. So yes, I’ve had quite a few GPS that have said that go for more walks and eat a healthier diet and take extra vitamins has been said in the past, and a few other things, but I just turned around and said, I’m not doing that. And then the GPs gone ‘Okay, fine’.
If you think the exercise is bad, and you avoid, you can’t complain, because you haven’t done it. It hasn’t harmed you. But if you did it, many people that aren’t on social media and don’t know that it’s harmful, you’re screwed, because the messaging simply isn’t there. So this reporting system for non pharmaceutical harms, will help those people who are told to exercise by their GP, they will have a place to log that harm, which is what I’m hoping but unfortunately, it’s only people that take part in these treatments and get harmed that will be able to.
Yeah, and this is it. And I think because there’s been no kind of official… and nobody’s kind of really followed me up on that either. And when I said ‘no, I’m not doing that, because I know my my baseline and I know that this is going to do X y&z to me’ the GP or the medical professional at the time has never said anything or never kind of forced me into it. And never said ‘but this is what we’re telling you to do’. They’ve just kind of sat back and said ‘All right, well, I’ve recommended this to you if you’re not doing it that’s on your head’. So why I think that I’ve never felt that that’s a strong enough reason to, to report when maybe it should have been, I don’t know, maybe I’ve been just a bit too, kind of, I don’t know, uncomfortable and going ‘well actually, it’s just going to be too much of an effort to try and prove that that’s what they’ve said’ if that makes sense?
Yeah. Also, if you haven’t got a lot of energy, sort of having to advocate for other people because you know, well, I’m not doing that – it doesn’t affect me. You need amount of energy to advocate for other people. I think.
So, I I often speak on Nicola’s behalf amplifying her story. On this occasion though, the details are sketchy. It’s not something we’ve discussed at length. However, Nicola was prescribed Graded Exercise Therapy about a decade ago. I think however, it was in the context of Fibromyalgia, she didn’t have an M.E, or an Ehlers-Danlos Syndrome diagnosis at that time. So she was prescribed Graded Exercise Therapy for Fibromyalgia, which is I mean, that’s another whole podcast in itself. Sally, the way Graded Exercise Therapy has been utilised on chronic illnesses. But she was prescribed it and she knew, and has said ever since, that it made her worse. However, I’m not sure what, what she did about this, I’d have to reel through her medical records. But I think on that there’s a sort of very important point to be made that there was a study in 2011 which pulled all the research together on Graded Exercise Therapy, and it found that out of 4300-odd patients. 51% of them had reported harms. And at the time, in 2011, this paper said that hopefully this will bring about a new reporting mechanism for harms from non pharmaceutical treatments. And here we are 10 years later discussing this issue still, and nothing’s been moved forward. And I think you, you made a really important point, Sally, which was that it’s all very well, for those of us who either live with M.E or who care for someone with it, or who are advocates of it, to to have this knowledge, we are in the minority. Most people with an M.E diagnosis are not as engaged on social media as us lot. I mean, if you look at the size of some of the Facebook groups, I think the biggest one for M.E in the UK is around 14,000 people. We know, there’s, well if we believe official statistics, 250,000 people with M.E, which is of course a nonsense, therefore people won’t know. And, as you alluded to also, there’s this, there’s this conundrum, quite often, that people who are harmed by non pharmaceutical interventions, like Graded Exercise Therapy, won’t report it, because they just won’t go back to the practitioner. And so it’s it’s a myriad subject that we’re discussing here. But I think that, I think that there are several factors, which you picked up on very well, which need to be factored into this. But yeah, Nicola’s done it. It made her worse. And I don’t think she did, because as you say, there wasn’t a mechanism in place. And also, there’s an element of distrust for- certainly- people with the NHS and the systems as well. When you have been harmed by it, there’s the fear of the fact that if you do complain, then treatment is going to be withdrawn. There was a huge case, it was back in the late 90s, GPs were blacklisting patients who complained. And in the end, there’s, there’s so much to unpack with this with this issue. But um, yeah, I think it’s sorely needed.
In my own case, I didn’t realise that I had been harmed until a couple of years after the event. I had, what was in effect, I was offered, Graded Exercise Therapy, I didn’t do as I was told, because I’ve got too much common sense. I knew that going for a walk every day, and I kept trying to keep it at that pace of what I could manage. And then I did try to increase it. And sometimes it worked. But it wouldn’t necessarily be, I wouldn’t necessarily be able to do that for the next few days. So I’d go back to where I’d been originally. It wasn’t until a few years later that I realised that I had been going to a clinic for the treatments, at the same time as going through a 16 months worth of occupational health procedures, because obviously, I wasn’t working, that led to dismissal. And then I had a fight with the benefits to try and get contribution contribution based ESA. And that ended up going to tribunal. So I had about two years worth of increased pressure on myself at a time when I was very fragile. And it wasn’t until everything had finished and I wasn’t doing anything that I started to feel better, you know, sort of 6-12 months later, and I was thinking, you know, I was driving to clinic appointments. They were asking me to do things, but there was no accounting for real life, if you’ve got to make some dinner because there are children who need feeding, you know, that takes priority over some exercises that have been given. And there was also this thinking that every day is identical. Well, if you live in a busy family, then no, every day isn’t identical. And you have to do what you have to do not not what they’re prescribing.
So I’ll just jump in, sorry Sally, just think an important point to be made from this. The very fact that the three of us have no experience of complaining about harm from non pharmaceutical interventions really does sum up the problem.
Okay, so the campaign is petitioning Sajid Javid MP and Amanda Pritchard who, those of you who don’t know, is the CEO of the NHS, I’m doing both because the government has got a habit of ignoring petitions. So I thought if I do it two different places that will raise awareness for the CEO of the NHS of the issue, because she may not be aware. So they are the two people that we’re targeting with our petition and our campaign. Amanda Pritchard has responded to an email that I sent a couple of weeks ago now when I launched the campaign. One of the key things that ties into what we’ve just talked about is, I’ll read you a snippet of the email that she sent me. ‘The NHS has a patient public reporting route for patient safety incidents. However, given the therapy will depend to a large degree on the individual’s own situation and tolerance, it may not be appropriate to use this for CFS/ME. If a patient believes that a treatment they have received has not been effective or has had side effects, their normal first route to report this should be the organisation that provided the treatment through the Patient Advice and Liaison Service PALS. This should enable adjustment of the treatment. It also provides feedback to that organisation that may enable them to adjust the treatment they offer for other similar patients. That ties in to what Steve said two seconds ago. If a patient has been harmed by a non pharmaceutical treatment, there is no way on earth they are going to put themselves through it twice. So they can adjust the treatment, but it won’t benefit that particular patient. So the next patient won’t know that a complaint has just been made and they are offered exactly the same treatment in my mind anyway. So, with that in mind, why do you believe a new system is necessary when the NHS CEO seems to think the existing routes of complaint are sufficient?
Amanda Pritchard’s comments are mind blowing. I read it, because you, Sally, kindly forwarded me the email prior to recording this podcast, they’re absolutely mind blown. But they’re not actually surprising. For me, the main takeaway from what Amanda Pritchard said, was the comment where she said that ‘the NHS has a patient public reporting route for patient safety incidents. However, given the therapy will depend to a large degree on the individual’s own situation and tolerance.’ Unquote. That phrase is key. Because for me, it sums up everything and all the harm that has been done to M.E patients since, and before, PACE trial was published. Because essentially what Prichard is saying there is that, well, if it harms you, it’s kind of your own fault, or you’re the owner of that harm, because the therapy depends to a large degree on the individual’s own situation and tolerance. In other words, well, if it’s harms you, it’s kind of down to you really, it’s on your head. And this is this whole mantra and ethos and mindset, which has infected the NHS because of PACE trial and the psychologization of M.E and countless other conditions. Therefore, even with the updated NICE guidelines, which have explicitly removed Graded Exercise Therapy, this is from the CEO of the NHS, and that whole mindset, says that mindset still exists. And as I’ve repeatedly said about the NICE guidelines at the time, it changes very little, because you cannot get into these powerful people’s heads and tinker with the way they think. And so therefore, a reporting system, which isn’t just based around the patient, saying, ‘well, I feel like this and this has done this to me’, which can then be immediately batted back to the patient as ‘well really, it’s your fault for doing it wrong, or you or you did too much, or it’s your circumstances, etc, etc’. A reporting system that is robust and rigorous, like the current Yellow card system for pharmaceutical treatments, this reporting system is needed now, because it will play a part in changing that mindset which still pervades the NHS in the in the way it deals with M.E patients and other patient groups who are saying ‘we are not well and these things, these treatments, these interventions are making us worse.’
Yeah, just to drop this in another snippet from her email. She said ‘NHS England and Improvement supports the NHS to monitor patient outcomes locally to ensure high quality care is provided. The new NICE guidelines should help guide appropriate provision’ which is absolutely rubbish because since the 29th October, clinics are still offering Graded Exercise Therapy and Cognitive Behavioural Therapy, and now MECFS patients have been referred by GPs to independent gyms to do exercise-based rehab. How is that in accordance with the NICE guideline at all?
Exactly. And and as NICE admitted in the legal documentation from the person who was challenging, they’re delaying the guidelines with the judicial review, NICE explicitly stated that, and I’m paraphrasing here that ‘well, we do these guidelines, but medical professionals don’t have to follow them.’ So it there’s, it’s a nonsense from Pritchard to make make that kind of statement. And moreover, I mean, this is a separate issue, but it does intersect with this. If you look at the health care bill that’s currently going through Parliament, where the radical shake up of how the NHS is structured. The way the NHS organises itself is about to change anyway. CCGs are going and in their place are now the merging of health and social care. So the NHS is going, it’s coming down to a huge reorganisation anyway, how that’s going to affect what Pritchard is saying remains to be seen. But that that’s another factor in this entirely. There’s half a book on this, Sally, I think.
I know. I had hoped to keep it short, but I don’t think we can! Have you got any thoughts on this?
So I yeah, I think Steve’s kind of summed it up really well. I think like as an M.E patient, I think it’s really desperately needed to help empower the M.E community or any other community to actually start reporting harms in the first place. I think then, I think you’ll find that there’s a majority of us, like I said, earlier, I said that I never reported any non pharmaceutical harms when actually, I was probably in the right to. Because there was no, you know, I didn’t know what to do. I didn’t know where to go. I just kind of sat back and took it, it was almost like this gaslighting and ‘oh you know, M.E is, there’s nothing physiological with M.E, it’s all in your head’, but also now gaslighting with ‘you have to accept what I say because I’m a GP’ and if you don’t like it, you don’t do it. But at the same time, ‘you can’t say anything bad against me, because you’re refusing that treatment’ – if that makes sense. So I mean, like having some way, kind of an easy, simple way that people can actually report these harms will empower the community. So you know what, actually, that is not okay. The way you spoken to me is not okay. What you’re referring me to is not okay. And I will highlight that in a system because that shouldn’t be happening and that needs to stop.
I wonder, if they haven’t taken part in it, I wonder if it is reportable. That’s the only thing we’re going to come on to that. Linda, what are your thoughts?
I just wanted to bring out that the new NICE guidelines. On page one, it says your responsibility, all problems. Bracket adverse events, close bracket related to a medicine or medical device used for treatment or unapproved procedure should be reported to the Medicines and Healthcare Products Regulatory Agency using the yellow card scheme. Now, that is actually quoted on the first page of the new NICE guideline, despite the fact that obviously our treatments in inverted commas or previous treatments aren’t actually a medicine or medical device. But they’ve agreed that any problems or adverse events should be reported. Now that to me, says, well, that’s fine. Give us a yellow card scheme that we can actually report it to then please, it’s as you said before, it’s not just the M.E community, there are so many people with long COVID And with mental health issues, who have had various treatments in inverted commas, that have not been beneficial, and all these people need to have the opportunity to be able to, to report harms caused.
Yeah, you’ve just nicely moved over to long COVID. That’s what I was just about to mention. Also in Amanda Pritchard’s email, she said ‘the NICE MECFS guideline should not be used for long COVID. The guideline was created before COVID and most of it was created before COVID-19’ So it’s not to be used for long COVID. So in my email this morning, I said are you aware that 70% estimated 70% of long COVID now have post exertional malaise? Post Exertional Malaise is not included, as far as I know, in the long COVID NICE guideline. So that means when long COVID Patients are recommended exercise there is nothing written down to say that actually should be contraindicated and I know as a long COVID patient, that they are recommending exercise because, my very first referral, so I got COVID on the 23rd of March, my first referral anywhere was November. And that was to respiratory. When she checked that my lungs weren’t knackered. She said, ‘Oh, it’s deconditioning, you need to exercise 30 minutes, five times a week’. Now, if I hadn’t had M.E, if I wasn’t an M.E advocate, if I didn’t own an MECFS online training company, I would have done that exercise. God knows what I would be like now, if I’ve done it. I did complain about that to the respiratory consultant and she said ‘Well, obviously with M.E, you would use your own common sense and only increase your activity as appropriate. But you can’t assume that M.E patients know about Post Exertional Malaise. She didn’t know about it either. It was only after I sent her the Workwell Foundation, bits and bobs and all the other resources I could lay my hands on. But the fact that she’s now said, the NICE guideline should not be used for long COVID, when 70% have the key characteristic of M.E, whether they’ve got M.E or not, they’ve got the key characteristic. So surely she can see the recommending exercise to long COVID patients is not good. And that’s why the campaign is for MECFS, long COVID and many other patient groups, because I’m not an expert on every single patient group there is and I’ve learned about conditions that react badly to non pharmaceutical treatments. Across the board, if you’ve had a non pharmaceutical treatment recommended to you and you’ve deteriorated as a result, report it here, whatever illness you got. So, that leads me nicely onto the last bit, what do you think the new system should look like? So, in my mind is a very simple, easy to fill in database with dates, times, names, addresses, and outcomes that are relatively easy to fill in for patients. They aren’t overly technical, you don’t have to put too much information in and you put contact information for it to be followed up. That’s what it looks like in my mind. Steve, what would you want a new reporting system to look like?
Exactly that, I would say. Well, what I would also add is that, and obviously you’ve thought of that, but I think it just needs to be explicitly said that this information needs to be pooled centrally, by the relevant authorities. So we can start having a proper database on exactly the real number of people who are being harmed by non pharmaceutical interventions. Because while the 2011 study was all well and good, and it was very eye opening, it was just based on other research papers, that’s not the real world, we need real world data on how people are being harmed by non pharmaceutical interventions. Therefore, it will directly lead to us being able to start to break down the narratives and the mantra that still exists within the health service about that somehow, if people are harmed by these interventions, it’s their fault, which as I said earlier, maintains the notion that a lot of chronic illnesses are somehow partly or fully psychosomatic. So we’re everything you said, Sally, but with the caveat that this information has to be pooled, and there has to be someone has to step up and take responsibility and accountability for this somewhere within the divisions of the Department of Health and Social Care.
Yeah, I don’t care who runs it. I’ve contacted the Department of Health and Social Care, NHS, CQC Care Quality Commission, and other people. Loads of charities that aren’t M.E, just broader national charities that deal with health and policy, have said ‘Oh, we’ll create a database patients can can complain to us, and it’s like, no, we’ve got that already. We’ve got anecdotal, I guess, folders in an office somewhere with lots of stories in it. But we need somewhere central official attached to government and or healthcare.
You just made a very important point there. We have anecdotal evidence, which is the qualitative evidence. And this was something that NICE picked up on and as I wrote at the time, the draft version of the NICE guidelines from November 2020, very much focused on the qualitative evidence, the anecdotal evidence – it’s finalised guidelines changed and it explicitly stated about the quantitative, these researched and evidence and measurable facts and figures, on the harm that Graded Exercise Therapy caused. What this caused was a complete meltdown of the proponents of Exercise Therapy and the psychologization of illnesses, and I think that’s in part what provoked such a backlash from the Royal Colleges. Therefore, my point is that is extremely important that you highlighted the fact that we have qualitative evidence, we don’t need that. We need quantitative fact based pooling of data from patients which is, which is specific and measurable, which again, can be used to rebuke the narratives that are coming out from certain quarters in the medical establishment.
Now, I wonder what that could be? Is it things like heart rate?
Yeah, exactly. heart rate, blood pressure,
Glucose tolerance testing would be another important one, especially within M.E, it could be stuff like SPO2 and tidal co2, there’s so much that can be done. And a lot of this can be done at home by patients, if necessary. You can monitor your SPO2, you could monitor your own tidal co2, blood pressure, heart rate, all these things can be self monitoring. So there, you have, you only need to look at the research surrounding cardiopulmonary exercise testing and M.E to realise what you can actually show quantitatively about harm from Graded Exercise Therapy, all the information is there, as all three, or our four of us are aware. So it can be done, but whether people have the volition to do it within the Department of Health and Social Care in its independent agencies remains to be seen,
I had a fitness tracker for my birthday this year, I couldn’t understand why I’d had new symptoms. And within a couple of months of wearing the fitness tracker, I could see that my heart rate goes wild and whether that’s getting up to make a cup of tea, or particularly bad if I’m in the shower or climbing the stairs. So that’s really identified a lot of things for me. So, you know, I can use a stool in the bath to have a shower. You know, you can spot things and identify, oh, you know, I’ve been standing up for too long or I sit down to chop some vegetables. So, exactly what Steve said there are plenty of things that can be done quite simply to provide that evidence
Kat, what do you want the system to look like?
I think it’s genuinely all be covered in a really kind of clear and concise way. Yeah, just needs to be you know, easily accessible and easy to use, I think is, and then obviously everything else on top. Yes, that’s literally everybody said everything else that I was gonna say
Just thinking about the MHRA. Patients don’t actually have proof, do they, that they’ve been harmed by drugs? Or devices? Do they? When you reported your harm to the MHRA, Kat, what did it ask for? Because you haven’t gone to a doctor for specific tests or anything so you’re reporting your own personal experience and this is what happened.
Yeah, obviously, yeah, so it was like the vaccine batch number, where I lived, what symptoms I had, and how it affected me, and if I had a diagnosis, what was it? Essentially, is what it said.
Exactly, so if they are prepared to take that amount of information for a drug or a device. Why can’t they take a similar amount of information for a non pharmaceutical treatment?
I just thought I’d stay Sally. I think you’re doing great work on this. I find it frustrating that not not enough people are picking this up and I think also not enough people are seeing the intersections and the crossovers between M.E and other conditions and the reporting of harms. I think it’s extremely important, I know from not only Nicola’s experience with M.E, but also experience with Ehlers Danlos Syndrome. That’s a whole other area, on the NHS, Ehlers Danlos – most of the treatment options are non pharmaceutical interventions. So, and now I mean that’s without even going into the kind of the the frontline emerging treatments for EDS surrounding the cranial cervical and atlantoaxial instabilities and what can be done about them, so it’s it’s a really it is a really important topic Sally and it and it broadens out into so many other conditions and it, but it also addresses inadvertently the issues as I kept referring to around psychologization of illnesses, and I think it’s crucial in this so all power to your pen on this one.
Thank you, it is hard work, trying to get people to engage with it.
It’s ridiculous. You shouldn’t even be in this position in the first place. But that’s another podcast entirely.
I’d just like to say, I just echo what Steve said, I think you’re doing an amazing job. I think you’re doing a fantastic job and it is frustrating seeing people kind of shout that they want their experiences heard and shared. But at the same time they’re not engaging in something which could essentially make that happen.
Sharing everything and, and encouraging everybody you know, patient power and all that, just everybody try, do your little bit and sign a petition or write to an MP.
Yeah, I just think every signature and every letter to an MP or Lord Kemal, the better really, all in it together. Anyway, thank you to all three of you for talking to me today. Very interesting.
Nice to see you all.
Thank you for your ongoing support with this campaign.
Love Sally and Foggy (OBVIOUSLY)