Which heart rate monitor for ME/CFS?

heart-rate-1375324_1920There’s a very interesting discussion about wearable heart rate monitors on Science for ME. I’m not going to reproduce those discussions here but you might want to check them out. It’s free to become a member and it’s a very good forum.

There’s some research which suggests post exertion malaise (the cardinal symptom of ME) occurs, or worsens, in response to exercise and that it may be lessened or avoided by maintaining a lower heart rate. This may explain, at least in part, why people with ME cannot tolerate exercise. Exercise, including graded exercise therapy (GET) is the most dangerous thing a person with ME/CFS can do. So theoretically, by keeping your heart rate down to around 50-60% of maximum you have less symptoms. Or to put it a better way, you can avoid an increase in symptoms. This may still be difficult, or in fact impossible, for some sufferers as their resting heart rate is already close to that 50-60% range and very minor activity, something simple like standing up may push the person over it, but for some it may be possible.

If you do have a little leeway then you may even be able to safely carry out very light exercise (such as stretching, or light resistance training) without inducing a crash if you can keep your heart rate below 50-60% of maximum. I’m not sure there’s enough scientific evidence for that, so tread carefully, but it might be worth exploring, with the caveat that you cannot exercise your way better from ME/CFS. All you might be able to achieve is a small increase in fitness without a worsening of your ME/CFS. Maybe.

A rough calculation of maximum heart rate is 220 minus your age. Multiply that result by 0.60 (60% of your maximum heart rate) and try to stick below that, or 0.50 (50% of your maximum heart rate) may be better but harder to achieve. Each individual is different and it’ll probably require some trial and error.

I have been meaning to get a heart rate monitor for a while but was overwhelmed when I first began looking. There are lots of devices on the market nowadays. The market is largely fitness orientated but it is still finding its feet and some devices are more niche  than others. I think the market still has some maturing to do, bugs to iron out both in terms of hardware and software and that means you need to exercise caution when buying a device because chances are a lot of them will have major design and manufacturing faults, particularly in the lower price brackets.

From what I can see the main thing to avoid are fundamental product killers like irreplaceable rubber straps which are known to snap, meaning the product goes in the bin a few months after you buy it. And you want to be careful not to pick a heart rate monitor that is totally inaccurate too. Although heart rate monitors are very common on these devices I think this is where most technological improvement is still required and there are certainly some limitations to be aware of which I’ll touch upon.

I’ve looked at what devices are reviewed if they look suitable or not. That’s a bit further down in this article but first I started by listing my must-have features. Your list may vary to mine. In terms of budget I’m looking roughly in the range of £80-£120. That rules out all the true smart watches such as the Apple Watch which are more expensive, instead I’m looking really at fitness trackers, some of which are bands and some are more watch-like. Most will provide notifications from your mobile phone for example, but will not allow you to respond via the device. Some do have native GPS in the watch while others require you to have your phone with you in order to use that functionality. This isn’t actually an issue for me either way as I won’t be using GPS to log where I’ve been on my runs because running – walking even – is totally out of the question for me.

Essential features:

  • Decent heart rate monitoring
  • Ability to set heart rate threshold alerts (beep, vibrate, or both)
  • Heart rate recording over time with data I can access
  • Real-time continuous heart rate monitoring with good update frequency
  • Waterproof (I don’t want to have to take it off when I have a shower)

Nice-to-have features:

  • Decent sleep tracking
  • Bedtime alerts (to encourage me to get to bed earlier)
  • Decent battery (I don’t need this as I don’t get out much, but come on, who wants to have to plug it in every day?)
  • SP02 (I’d like to know my oxygen saturation because I get breathless and it’s a useful measurement for sleep monitoring)
  • Gentle wake up alarm in light sleep
  • Recurring alarms (I have to take medication each day, I often forget and this might help)
  • Activity tracking (I don’t do much but it might be useful to know how small activities impact me)
  • My preference is for a watch rather than a band/bangle and a changeable strap rather than a rubber one.
  • Apps – with some devices you can load third party apps onto them, which make use of the sensors and data they collect to do bespoke stuff that the watch doesn’t do out of the box. I don’t know how useful this will be in practice but in theory someone with the right skills might code an app or two that provides functionality useful specifically for people with ME/CFS.
  • Heart rate rhythm/variability – I doubt think this is likely to be available via a wrist-based device though, so I’m not expecting to get this.

As an aside: most wearable need to be paired with your smartphone and/or computer so that you can easily set things and view data. Most of the time you can do this, or some of this, using just your watch but it’s easier on device with a larger screen. Compatibility with smartphones tends to be good for most devices but if you buy one you might want to check first that it’s compatible with the phone or computer OS you use.

Things I don’t need:

  • GPS
  • Exercise tracking and goals
  • Notifications from your mobile phone

Focusing on the features I do want, here is a bit more detail on how they work and why I want them:

Heart rate monitoring and threshold alerts

There are two main forms of heart rate monitoring: electrocardiography (ECG) and photoplethysmography (PPG). ECG is what is used in a hospital setting and that’s because it’s accurate. ECG directly measures the electrical signals from your heart. You can buy devices with chest straps to measure your heart directly and they are very accurate, but it’s not convenient and a lot of people with ME struggle to breath enough already without a strap around their chest to make it even harder. PPG is less accurate than ECG, using a light to sense subtle changes in blood flow. PPG can be used on your arm which is why all wrist-based wearables we’re looking at use this technology. Essentially this means it’s very important that the algorithm that interprets the PPG signal is good so that it accurately calculates your heart rate. There may also be some hardware considerations, as the sensor needs to be able to touch your skin and block out ambient light to get a good reading. Some devices manage these things better than others. The good news is that the main drawback of PPG is in measuring accurately when people move around a lot, meaning the technology can struggle to perform when people exercise but the technology should cope just fine with me lying in bed or sat on my sofa.

If you can measure your heart rate then you can avoid too high a heart rate and going into your anaerobic threshold. You don’t want to have to watch your watch all day long for when your heart rate gets too high, what you want is a device which can alert you if you go over that specified threshold. I’m hoping I may have capacity to try some very light and careful exercise, maybe just stretching; after a decade of inactivity I am very unfit, my weight’s likely to become a problem. I won’t be able to get fit, but if I can improve my fitness even a little that might put off development of other health problems.

Real-time continuous heart rate monitoring with good update frequency

This is important. Not all fitness trackers measure your heart rate 24/7. And even those who do may not do it quite how you expect. What many trackers do is they regularly take your heart rate, say once every ten minutes, and they do this because it saves on battery power which you’ll understand is a limiting factor on these small wrist-worn devices. The problem is this won’t meet my needs. I want to know in real-time if I am heading into anaerobic territory, not after it is too late. Some trackers also give averages rather than true readings, so they sample continuously but every 30 seconds work out an average and report that. That also isn’t what I want.

Sleep tracking

Typically wearable devices guess at this quite a bit. They tend to assume you are asleep if you have not moved your arm for about 1 hour. I think this is a bit rubbish. Some devices also look at your heart rate to help work it out, or you specifically tell the device when you are going to go to sleep.

Most also do not cover daytime naps. One or two do. I tend not to nap in the daytime so this isn’t a problem for me, but it’s something to be aware of if you are a napper, which I know a lot of people with ME are.

In terms of what they are measuring, some measure heart rate, but most measure movement, and some measure breathing (I guess through recording noise via a microphone?), and some (but none of the ones I review below) also measure ambient temperature, which I figure might be useful but it’s not that commonly tracked by most devices.

What I’d really like from a tracker is something to tell me to go to bed! I struggle so much with getting to bed early – or rather, not late. I think because my brain functions a little better late in the day, which I suspect may be due to higher blood flow (we’ll see) and because once I lay down for sleep I have no distraction from my symptoms, they flood into my consciousness and I hate it. Still, a prompt to go to bed half an hour earlier than last night in order to optimize my sleep based on sleep data recording would be very welcome.

Finally, some devices can gently wake you up when they think you are in a light phase of sleep within a specified period of time. That might be handy, I’m not sure. At the moment I wake up eventually and then typically dose until I have enough energy to roll out of bed. But I’d be interested in trying this, maybe it would help.

SP02

SPO2 is a measure of oxygen saturation in the blood. I’ll tell you now that none of the devices I review below provide this feature, which surprised me – I know SPO2 monitors traditionally have a cord and device which you attach on your finger but I thought some watches may have this as a plug-in accessory. Or that maybe someone had figured out a way to measure this on the wrist rather than the finger (is that really beyond the capabilities of man?). I have a simple and cheap SPO2 finger monitor which I wore a few times at night in the past and I found that my oxygen level drops sometimes for a short number of seconds (into the 80%s, which is bad). I’m pretty sure this was accurate too because my heart rate (also measured by the device) would increase to try and compensate at the same time. But the device is not the sort of thing you can wear comfortably all the time. I’d like it on a wrist-based device (which would have to have true second by second recording otherwise it would miss it). Oh well, maybe in the future.

VO2 Max

Those who are familiar with ME/CFS research will know about the two day cardiopulmonary exercise testing (CPET) studies suggesting that those with ME cannot perform to the same level as the healthy subjects. Part of this test involves VO2 max. Some wearables are able to estimate this. Basically they have you exercise at a maximal rate (usually measured by ensuring the wearer is exercising within a certain heart rate rate zone that the wearable is measuring) for a certain period of time and distance (typically measured by the wearable using GPS to track distance). I wouldn’t use this – I wouldn’t be able to as I cannot exercise at anything like the rate required – but I’d be intrigued by this measure if I was only mildly affected as I could potentially carry out my own version of a 2 day test of my own to see PEM in action.

Ruling devices out with fundamental problems

There are a lot of different wearables out there, all a little different. I found it pretty overwhelming at first and had to work through the options which took me some time. I started by ruling out the devices with fundamental issues.

I don’t trust positive reviews you find on the internet, and maybe not all negative reviews either, but the negative reviews often do tell you if a product like this has known issues if they come up over and over again. What I discovered is that many wearables are plagued by poor design and cheap quality parts – watch straps often are made of rubber and snap, and if the strap cannot be replaced this means a fault like this kills your device.

This ruled the following devices out:

Fitbit Alta HR – as above, basically the same problems. What’s the point in a device if the strap breaks? Also reports that the screen scratches easily and cracks. Specific reports of sleep tracking being rubbish.

Jawbone Up3 – the company has gone/is going under from what I heard, which is why you can pick these up so cheap, but as with the Fitbit a lot of these rubber strap designed products just don’t last and it sounds like you’ll be lucky to get 6 months use out of it before the strap snaps and you have no choice but to pop the whole thing in the bin.

Garmin Viviosmart 3 – another with rubber straps that break and can’t be replaced. Looked quite good apart from that, but the device’s other features cannot rescue it from the major design flaw in how the thing attaches to your body.

Garmin Viviosmart HR+GPS – Straps which according to some reviews cause skin rashes/reactions. Not much better than a snapping strap really. Complaints of inaccuracies in activity tracking and bad GPS. Oh, and Bluetooth connectivity problems.

These might work for some and might be very good, but I want to avoid the hassle when they break and you have to try and get it fixed/replaced/refunded.

The finalists

Moving on, the remaining devices may have some common faults which I will highlight but nothing that fundamentally means I should avoid buying them full stop. Hopefully not anyway. Target prices below are based on the lowest price the device has been on sale at recently from Amazon.co.uk

Huawei Band 2 Pro – target price ~£50

s6-huawei-band2-2The Fitbit Alta HR didn’t make it this far, but if you like the look of the Fitbit device then you’re in luck because this band from Huawei looks very similar indeed, another sleek, minimalist device. Only, the Huawei device doesn’t snap. It’s well put together, and the touch screen is responsive. Reviews praise it for its accuracy of activity tracking (step counters etc) and although I won’t really be using those features much it suggest Huawei know what they’re doing because it’s hard to get right – or at least the majority of manufacturers appear to get this hopelessly wrong. While other devices add thousands of fake steps while tracking this device seems to get it right almost all the time. Another thing I won’t use much on account of not getting out much is the GPS but reports are that it is very good compared to the competition.

The strap seems reliable enough although it is a mix of silicone and plastic and doesn’t appear to be changeable. It also has a somewhat insecure fixing method where button fasteners pop into place and if you catch the strap on something it can un-pop accidentally. May not be much of a problem for me but for those more active it may not be ideal. It’s waterproof to 5ATM. As an added bonus it has a breathing coach, where you can complete breathing exercises and it scores you on how well you stay focused. I’m dreadful at meditation/breathing type stuff but maybe this will be valuable, to be honest even a breathing exercise is a physical workout for me, so maybe it would be a place to start in my case.

Heart rate tracking, heart rate limit alert, sleep tracking which includes analysis of your heart rate to assess the quality of your breathing, supports daytime naps too, native GPS, VO2 Max…This is a really good list of features and add to that up to 21 days battery life and this is starting to look like an impressive device for the money. The retail price of this device since it launched in the UK in September 2017 is £80 and that seems quite reasonable for what you get, but it’s been at around £50 at Amazon recently, which seems an absolute bargain. I think the main reason for this is because Huawei, although they are a massive company are not well known in the UK, they area a Chinese company and they have to overcome that brand problem where everyone follows the crowd and buys the familiar brands even if they aren’t as good.

The one area where the Huawei does fall behind the competition in real terms is the app — although it has everything promised, and isn’t in any way bad – it still isn’t as refined as most of the competition. I don’t mind this too much though, as long as the data is there, I’ll get used to how to access it. There aren’t that many complaints of fundamental faults that seem to plague the competition. My only gripe is that I wish it was more watch-like than band like, but you can’t have it all.

Fitbit Charge 2 HR –target price ~£90

charge2-black-silver-tpu-regular-0-89079973ccd38c8059a0a68eb21fc858I originally had this item ruled out as there are reports of significant inaccuracies in tracking (mainly activity tracking with isn’t much of an issue for me anyway) but more worryingly there are lots of reports of the straps snapping/falling apart, and I thought the device did not have changeable straps. Turns out I was wrong about that as pointed out to me by a reader – thank you “zzz”.

You can change the straps and there’s a good selection at a reasonable price.

The device is quite comparable to the Huawei Band 2 Pro in terms of features. It doesn’t have native GPS but that was never a big deal for me anyway. Although the screen is similarly small to the Huawei the Fitbit gives you the option to customize the clock face a little, which is nice. It also tracks sleep and looks almost as good in that respect.

From what I can see it claims to measure HR about every 5 seconds in standard operation, though there is some good info to suggest it’s really achieving something more akin to every 10 seconds in practice. Still, that is a lot better than Huawei Band 2 Pro, which I can’t find official data on but I am collecting data on and will post about once I’ve figured it out a bit more (it’s nowhere near as frequent). Both bands are similar in that you can set an exercise mode and then it tracks every second.

The other advantage of Fitbit is that the app is more refined.

This looks a good device in my mind, there are only a few drawbacks to the Fitbit: There is no heart rate alert (this might become less of an issue for me in time once I learn my limits), it is not waterproof (it is described as splash proof but you can’t shower in it), and there is no integration with the Apple Health app.

A good device though which might suit a lot of readers.

Huawei Fit Smart watch – target price ~£115

fit-kv-watchIt’s the design that looks the most watch-like, and you can change the design of the watch face display. The materials used seem pretty good according to the blurb. Decent quality glass on the watch’s touchscreen so that it shouldn’t smash or scratch. Stainless surround which looks of good quality and a strap made of materials that have been tested not to cause allergy. The battery will last up to six days apparently. There are some reports of the rear glass which houses the heart rate sensor delaminating/cracking though, which is a concern. There are also some reports of connectivity problems with iPhones which is also a concern, though it’s possible later firmware updates have fixed this. These problems almost make me want to rule it out but it does come with a two year warranty in the UK (as does the Band 2 above) so that at least offers some protection should you run into problems.

The clock face on the watch is always on as opposed to most smart watches which is more convenient. Huawei seem to be able to afford this feature because the watch’s battery use seems to be quite efficient (though not as efficient as the Band above). Most other smart watches turn on when you rotate your wrist, which is acceptable, but on all the time would be better.

You can tell the watch to constantly monitor your heart and when you do this it displays data over the last four hours including curve, minimum and maximum, but not the current measure. I think this is rather odd and makes me suspicious they aren’t sure it’s terrible reliable as a real time monitor – because PPG technology can be inaccurate manufacturers prefer to use an average measure rather than a real-time measure. You can see the real time heart rate but only in the app, not on the watch itself (at least not in the continuous measure mode).

Like the Band 2 above you can easily set a maximum heart rate alert to ensure your heart rate doesn’t go too high and kick off PEM.

The watch is waterproof to 5ATM, and unlike a lot of other devices I haven’t read any stories of this waterproof claim being a myth – it looks like Huewai can be trusted on this. It’s promoted as suitable for swimming. I used to swim and would have loved – LOVED! – a watch like this back then, but although I can’t swim any longer it’s good that this will survive a shower (not hot!) or some accident that sees a glass of water pour over it.

This watch doesn’t have native GPS – that is the main thing is doesn’t have compared to the Band 2 from the same company. It can use your phone’s GPS instead which means if you go on a run you’ll need to take your phone with you to use this feature – not a problem for me as I rarely leave the house and haven’t run for 15 years.

Garmin Forerunner 35 – target price ~£105

sc-02-lgAttractive if a little bulky looking, this watch is designed primarily for the runner. It does everything necessary, and is waterproof to 5ATM. It has good battery life, lasting up to 9 days. It comes with a silicone strap but like the Huawei Fit Watch above you can change the strap if you want to, which is great. It has music controls for your phone, which is a nice feature if that’s what you’re after.

Quite a number reporting the heart rate monitor isn’t very inaccurate. That’s a bit of a concern although it’s always hard to judge these comments because these devices have to be fitted correctly in order to work, and there are lots of positive reviews also, but it’s potentially an issue. There are also a fair number of complaints about problems syncing the watch to your phone.

The heart rate is recorded every second in an exercise mode, but otherwise the measurement is variable, certainly not constant.

Garmin Vivoactive HR – target price ~£125

cf-lgFitted with a colour screen, it looks quite an attractive display. The battery lasts up to 8 days which seems pretty good. Like the other devices we’ve looked at it’s got the essential features and like the Garmin Forerunner it has changeable straps. That’s important because like with their Vivosmart offering there are complaints that the rubber strap causes them a rash. It is only because the strap is replaceable that this item made it this far in my review. The most concerning thing is that a fair number of people report that the screen can suddenly crack for seemingly no reason – the watch is sold with “chemically strengthened glass” so that’s particularly disappointing. And there’s also reports that it is not properly waterproof despite a 5ATM rating, which if true is a big problem in my eyes. I’d say this device was right up there but the faults might kill it, especially as it is one of the most expensive I’m looking at.

Like the Garmin Forerunner, heart rate is not measured constantly unless it’s in an exercise mode. It will periodically record your heart rate but it’s not clear how often.

Summing up

I’d have liked to have considered a Huewai Watch 2 but it was just a little too expensive for me. I’d also have liked to try a full-on smart watch like the Apple Watch, Garmin Fenix 5 or Samsung Gear Fit 2 but these were all more expensive and I just couldn’t justify it. If money is no object maybe check them out and see how they compare.

I went ahead and bought the best device, which is the Huawei Band 2 Pro. I didn’t buy it because it was the cheapest, that was just a happy coincidence (I’m not a cheapskate, honest!). The only thing it lacks is the ability to install third-party apps. I’ll report back how I get on.

Looking further ahead I hope the market matures, particularly with regard to getting rid of the fundamental flaws with straps that snap or cause skin reactions. Even though I’m looking at the lower end of the market those sorts of faults are still unacceptable. Hardware and software will improve, the same as how mobile phones matured a decade ago – you can’t afford to have hardware or software that doesn’t work, people will never buy from you again if their experience is poor. I don’t know who else will survive in the market as it matures, but it will be a difficult balancing act between keeping costs down and producing a high quality product and delivering more features – that’s what people want: lots of features that are relevant to them (but the fundamentals must be right first).

It’s an interesting market because it’s only going to grow. There is so much further technology can go with basics like sleep and heart rate tracking. And health tracking is the most interesting growth area in my opinion. Sure, anything to do with social media, fitness, information, and conveniences such as payment via your watch (already available on some devices) are going to sell but you compete with the mobile phone, with the laptop…wearables that tell us more about the body itself is the interesting area of the market. The FDA have shown an interest in this and sound like they are going to make it easier (and I guess cheaper) for companies to innovate and market their health-focused product. That’s absolutely necessary because otherwise the sorts of innovations that could be commonplace in ten or twenty years’ time won’t happen. I want to wear a watch that will inform me and the emergency services if it detects me having a heart attack, to measure glucose without needles if you have diabetes, to tell the wearer about their hormones, inflammation, medication even, that’s what I’m interested in seeing develop. For now though, I’m looking forward to taking a closer look at my heart and a few other basics.

Regardless of whether my experience with the Huawei Band 2 Pro is positive or negative I’ll write a blog post on how I get on and whether it proves helpful from an ME/CFS point of view.

edit: there are some comments from readers below and also some further comments/discussion of this article on a new Science for ME thread: https://www.s4me.info/index.php?threads/blog-clark-ellis-which-heart-rate-monitor-for-me-cfs.1567/

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NIH funds ME/CFS research: Thanks, but… Please, Sir, I want some more.

dollar-517113_1920

Good news

Earlier this week the NIH announced funding of three collaborative research centers, along with a data management center. According to the NIH’s announcement the initial cost in 2017 will be $7 million. It’s actually around $30 million over five years to these centers.

Here is a very brief breakdown of the teams that won funding with links to information on their projects:

It’s great to see both new and existing researchers getting funding to study ME/CFS. I’m particularly interested in the work of Dr Unutmaz, an immunologist who got his first grant to study ME/CFS in the last year. He is active on Twitter and appears to take an interest in the wider issues in the community – as a lot of the other researchers above also do, I might add, I’m just encouraged to see new researchers getting properly involved also. Having new people join the field is essential.

Huge congratulations to all those who won these grants. Well done NIH for funding some promising-looking research.

There were a number of other research groups who missed out on funding in this round of applications. I hope they will all apply again in the future for more funding, and that other groups will see it is worth researching this disease, because the NIH needs to fund much more research into ME/CFS and is going to be under pressure to do so.

Not having published on ME

One of the most notable groups to miss out on funding was that of Professor Ron Davis at Stanford University.

It’s been reported that one of the reasons Ron Davis’ team were rejected was because he hadn’t published on ME/CFS before. Naturally you would expect the NIH to look at this when assessing applicants. But it sounds like one of the purposes of this NIH funding is to encourage new researchers into the field. By default then, why would we expect researchers to have published on ME already?

It isn’t just Ron Davis anyway, it’s his whole team in the application and it includes other researchers who have published work on ME/CFS. So it seems a flawed criticism.

A child with ME

It’s widely known that Dr Davis has a son with ME. It’s been reported that this was noted in the review of his application.

I don’t know the context. If I’m being generous, maybe it was noted and meant as a positive, but it sounds like Dr Davis’s impression is that it was meant as a negative. If that’s the case then I think the NIH might need to get a bit more up to date. If we look at the most backward place on Earth – no not North Korea, I’m talking about the UK – even the UK with its persistent focus on outdated and unscientific behavioral based models of ME/CFS does not consider an expert having a family member with the disease they are working on to be a conflict of interest.

Stanford a mediocre facility

It was also reported that Dr Davis’ facility was described as “mediocre”. Again, I’d like to know the context of this comment, but this is Stanford we’re talking about, one of the very top facilities in the world. I think if I was a reviewer of applications I’d be too embarrassed to write such a thing.

So did the NIH get this wrong?

Competition was strong; those who got funding got it because they deserved it. Their projects look great, maybe the best projects the NIH has ever funded into ME/CFS. Someone else not getting funding does not mean their research proposal was poor.

Given what we’ve heard about the review comments it suggest that maybe the problem is with whoever was assigned to review his team’s application; it may be that Dr Davis and his team just got really unlucky this time round. None of the others who got rejected have raised concerns about the reviews comments they received. Maybe the NIH needs to look at whoever reviewed Dr Davis’s application because it seems at least some of the review comments were unreasonable – silly even.

I haven’t seen the research proposal, the actual application, and I haven’t seen the actual review documents relating to that application. That makes it difficult for me to reach any kind of firm conclusion but supporters of Dr Davis’s research are always going to question decisions not to fund his work, particularly when it has happened several times before already. It is frustrating.

But I don’t believe that the NIH has it in for the ME/CFS community, or has a bias against one of the most reputable researchers in the field. When I first got sick this was definitely the case, the NIH was guilty of neglect, and even abuse toward the ME/CFS community. But there is evidence that attitudes have changed at NIH over the last few years. They are funding appropriate research at last and there seems to be a recognition that there is a huge unmet need in this disease. They must do much more, I’m not about to go easy on the NIH, but the tide seems to have turned.

Dr Davis and his team are smart and experienced; I’m sure they’ll take the right steps to increase their chances going forward. This may mean jumping through some hoops; publishing in a peer-reviewed journal for instance. If they tick the NIH’s boxes and couple that with a bit of luck in the application review process I think it’s only a matter of time before they win NIH funding.

The bigger issue, I think, is that there were more research teams that missed out on funding than those who got funding. I imagine all those who lost out feel they made great applications and deserved funding. I expect it is normal that two thirds of applicants miss out, but this is a field which is in serious need of support and nurturing to get it off the ground. There’s a valid argument, I think, that the NIH should  be awarding funding to more than 3 out of 10 applicants in these circumstances.

Summary

Some excellent researchers have got funding for high quality biomedical research and there are new faces brought into the field.

The NIH has begun to follow through on its promise to change its approach to ME/CFS research, to fund appropriate biological research. Credit to the NIH for that, and thank you to the individuals who helped make it happen.

There must be more though. It’s a good start, I recognized that, but ME/CFS research funding still makes shocking viewing if you look at the numbers against any other comparable disease. The NIH funded around a third of applicants this time around. Great, but we need more from the NIH. And from congress, who can compel the NIH to do more.

Every day more people get this disease. It is indiscriminate. It is devastating. Tomorrow it could be your loved one. Too many are children. Some have had it for decades on end. Many are severely sick, suffering a death like state, but without the release of death. Some do die.  There is no treatment at present. None. This is unusual for a disease of this magnitude.

So please accelerate your efforts. We really need to be getting research funding into the hundreds of millions of dollars bracket very quickly. Thanks for working hard for us to make this happen.

Graded Exercise Therapy causes harm in ME/CFS. Everyone knows that, right?

harmful

Graded Exercise Therapy should come with a warning, like dangerous drugs do.

What is patently obvious to the majority of ME/CFS sufferers is not at all obvious to most others. It is not obvious to NHS staff. It not obvious to academics and politicians. It is not obvious to the public.

There are many reports of GET causing harm to ME/CFS patients. I myself was harmed by GET and you can read my brief story here on #MEAction. These accounts are not without value but the problem is that these reports are anecdotes, individual cases which have not been formally validated.

Patients are not seen as reliable witnesses when it comes to the treatments they themselves experience – at least not until a qualified academic validates that experience. But I don’t want to moan about that here, I see the need for pragmatism; we have to work within this reality to expose the harm GET causes.

 
This week saw a paper published in the Journal of Health Pyschology from Keith Geraghty et al, an analysis of a large survey from the ME Association (n = 1428) looking at symptom changes following GET, CBT (cognitive behavioral therapy) and pacing in ME/CFS. The results were also compared with similar data from other patient surveys (n = 16,665). One of the most significant findings of this review was that graded exercise therapy caused significant negative results in patients (54%–74%) across surveys. The review also found that CBT was associated with deterioration, but I am focusing this blog post on GET. The review stated that:

Where GET was the main content or included in combination with any other treatment course (CBT or PT), patients tended to state that their symptoms worsened more frequently than improved.

Some people may not yet recognize it but this paper is a big deal because it formalizes and validates the experience of patients in a form that scientists and officials can take seriously. This paper, on its own, will not convince everyone that GET is harmful to patients, but what it will do is highlight that there is a question that needs to be answered: Is graded exercise therapy really safe in ME/CFS?

That is a significant step forward. But if GET harms patients, we need to do the work to demonstrate that, and that means more papers in peer-reviewed journals. I asked Dr Geraghty about that and this is what he had to say:

“Doctors and scientists rely on a limited number of randomised controlled trials that suggest graded exercise is a safe treatment for ME/CFS when patient surveys consistently find high levels of negative response to GET. We know that RCTs use strict criteria to define serious adverse events, like hospitalisations, however such methods may miss the types of bad reactions ME/CFS sufferers experience after exercise.

“We must also remember that GET therapists are instructed to teach trial participants to ignore symptom flare and push beyond limits, as the theory behind GET suggests patients must overcome anxiety related to activity and view negative thoughts as dysfunctional cognitions. This might bias how patients report adverse events.

“Much more research is needed, particularly from the patient perspective and I will be focusing on potential harms in the near future in my own work.”

Dr Geraghty makes some good points, and I know other researchers I have spoken with have similar concerns. I’m encouraged that researchers are looking in this area and I’m pleased that Dr Geraghty is planning more research on potential harms.

The existing evidence for GET’s safety is woefully insufficient. Smith et al in their review of treatments for ME/CFS conclude that:

Harms were poorly reported in exercise trials, and no subgroup analyses were performed. One trial reported small but significantly more serious adverse events (17 exercise versus 7 usual care; P = 0.04) and more nonserious adverse events (992 GET versus 977 usual care versus 949 adaptive pacing versus 848 CBT) in the GET versus comparison groups, although adverse reactions attributed to the intervention were similar between groups (48). In a smaller trial of GET compared with placebo or fluoxetine, total withdrawals were greatest with GET (37% versus 22%) (23). In addition, in a trial of GET, 20% of patients declined to repeat exercise testing because of perceived harm of testing (52).

This is not a surprise because trials of behavioral interventions, across medicine, have long failed to live up to the same standards that pharmaceutical drugs have to meet when trialed for safety.

Take Rituximab for comparison, a drug currently in phase 3 trials in ME/CFS – this drug, like others, have had to prove they are safe enough to justify the benefits they offer. The safety of the drug has been scrutinized, both under trial conditions and in post-marketing surveillance. This is because no drug is safe, no one would ever claim that a drug is completely safe. No one would expect it to be and no one would believe it if they told it was. Yet we have people claiming GET is safe and they are given a free pass, presumably because it’s a behavioral treatment aimed at patients who they believe are suffering from fear avoidance behaviors and de-conditioning.

In contrast, Rituximab has proven itself to be a relatively well tolerated treatment. There are many papers dedicated to evaluating side effects of the drug. These side effects can be very serious but are not very common. It is a drug that has been used for a long time in diseases such as rheumatoid arthritis and lymphoma, with many hundreds of thousands of patients treated and followed up in large numbers across the globe. This does not remove the necessity, of course, to look at the drug’s safety in ME/CFS, and that is what the current trials are doing. And it appears they are doing a much better job of it than any CBT or GET study ever has.

Why is it that pharmaceutical drugs have to meet these high standards but behavioral interventions do not? Is anyone even monitoring harm in the clinical setting from these treatments? Judging by the looks of the survey data reviewed by Dr Geraghty, the answer appears to be a big fat NO. If GET was a drug, it probably wouldn’t have made it outside a clinical trial in the first place, and if it did it would have been withdrawn long ago.

I am not scared at the prospect of one day having Rituximab to treat my ME, I would be terrified at the idea of every having to undergo GET again. This doesn’t stop my GP from trying to send me back for more.

Despite it’s many failures and limitations the best evidence we have of adverse events in an exercise trial is PACE. It provides only a tiny pool of data compared to many drugs, but it’s all we’ve got. 48 “severe” adverse events were recorded in the PACE trial (according to the researcher’s chosen criteria and methods of reporting and evaluation). A paper from Tom Kindlon earlier this year highlighted shortcomings of the safety data from the PACE trial:

the researchers identified 48 [severe adverse events] during the trial, though without detailing which trial arm they occurred in. This seems unfortunate especially given that the authors stated that there was a statistically significant difference between the number of SAEs that occurred in the GET group (17) compared to the specialist medical care (SMC)-only group (7).

Some of these SAE’s could, according to the investigators, “be considered to be causally related to the interventions themselves.”

It seems to me that the PACE evidence highlighted by Kindlon shows that GET does cause harm, even in the carefully controlled environment of a clinic trial. And of course you would expect the implementation of these treatments outside of clinical trial conditions to result in even greater levels of harm.

A big obstacle we face is the safety narrative from those promoting these treatments. Seemingly with growing frequency, GET is profusely stated to be safe by its proponents – when talking on the radio or giving quotes to papers, in presentations at conferences, in blogs and articles – this indoctrination fixes the belief that GET is safe in people’s minds and I think most people simply assume it has been scrutinized as carefully as drugs are.

Despite the lack of evidence that GET is safe, until more evidence is provided that GET is potentially harmful, the “GET is safe” narrative will continue to be effective.

GET and CBT sit precariously on a platform which has been eroded by exposure – exposure of the poor quality research on which the treatments are based. If GET is shown to cause harm then it is over – GET will be finished as a treatment for ME/CFS.

I don’t believe proponents of GET can prove it is safe, they can claim it, but they can’t prove it, because it isn’t. The harm GET causes however, can be proven, and we need to do that with more papers in journals. I hope more researchers and advocates will focus on this area, and those able to help fund such essential efforts will see the merit in those efforts.

Even if the risk is low (and Keith Geraghty’s paper suggests it is not low) then patients must be properly informed of that risk. Now children are beginning to be subjected to the same treatment under the NHS. Every day GET harms more patients.

We need more research of harms in journals before that is going to stop. No one pays attention to the sick, because the voice of the sick belongs to an individual, probably a benefit scrounger, with a disorder of dubious merit, and besides, everyone already knows GET is safe, right?

Why I am signing the petition to oppose MEGA

mega

MEGA has many facets: is it a thing of beauty or are its flaws too great?

MEGA is a proposed study into ME/CFS. There are good and bad aspects to it, so reaching a conclusion on whether to support it, or not, is not straightforward. But after careful consideration I have decided I am going to sign the petition opposing the study.

The MEGA alliance asked patients to endorse their study by signing a petition in support of them gaining funding to take the project forward (yes, there are two separate petitions). In the bit at the bottom were details about who was involved which includes the principal investigator of the PACE trial, and another researcher who has spoken highly of PACE and is running a trial similar to PACE in kids. Both promote a biopsychosocial (BPS) model of the disease.After some debate, someone launched a counter petition opposing the study. Right now what we have is a binary choice:

– Support the petition endorsing the study

OR

– Support the petition in opposition to the study.

You can of course do nothing but then you get no say at all, stuff just happens to you.

There are lots of potential problems with MEGA and these have been discussed on Facebook pages, blogs and forums such as Phoenix Rising. But these are the things that for me mean that I cannot support MEGA:

* Peter White’s involvement – he led the PACE trial. He promotes a BPS model of the disease that his own research does not support.

* Esther Crawley’s involvement – she ran a treatment trial of the Lightning Process on children with ME. She is now doing a graded exercise therapy trial on children despite there being concerns over the safety of the treatment.

* AYME involvement – Esther Crawley is an adviser for this organization so there is a clear conflict of interest. In my view AYME does a bad job of representing the interests of patients, one recent example I wrote about on my blog this spring.

I also have concerns over the definition that will be used to pick patients for the study, though I believe this may be something that those involved in the study may be willing to change, so it is not currently a reason why I am signing the petition. I don’t see any realistic prospect of them resolving the three issues above though, hence I will be signing the petition to oppose MEGA.

Some have pointed out that there are some good people involved in this study too, and I agree that is the case. There are researchers involved who have a track record of carrying out good quality science and I hope these people will do research into ME/CFS in some form. I want to find myself in a position where I can support them wholeheartedly.

I would like to specifically state that every patient I have interacted with wants these new researchers involved. The concerns are solely with certain individuals and organizations that I feel have let patients down over the years.

It has also been pointed out that as well as mental health questionnaires for 12,000 patients we will also get some omics data, and I think if genuine patients are picked this will be very interesting. The problem though is that patients are being asked if they want this study as it is and we are not being given a one or the other option. We are being told we get the good bits but must also accept the bad bits.

Given the new researchers involved are not considered experts in ME/CFS the study will be dependent on the advice of the so called experts White and Crawley. This could limit the good side of what we could potentially get out of this study and given its size and cost, if this study is not done properly it will set in stone an omics view of the disease forever. No one is going to be given funding to do something similar on this scale again if this study fails to show compelling evidence of something going on in omics. So the stakes are high.

Additionally, omics research takes time, a lot more time than it takes for mental health questionnaire and chalder fatigue scale results from the same study to be published and start being applied to all of us. If lots of people without ME/CFS but with mental health problems are entered into the study (highly likely based on the definition they tell us they will use) then a lot of those 12,000 study participants will demonstrate mental health dysfunction and not have ME/CFS.

It would probably seem quite reasonable to add these questionnaires to the study (it’s not hugely expensive). But off the back of the biggest ever study of mental health in ME/CFS (even though that is not the primary aim of the study) White, Crawley and other researchers who promote behavioral models of the disease will use this data to further research in that area rather than biological models.

So the question is, are you willing to take the risk of endorsing the bad as part of the deal to potentially get something good? Right now, as it stands, I cannot support it.

Some people who I like and respect a lot are in support of MEGA. I understand their reasons, and I too would love to support large-scale biomedical research into ME/CFS from some of the names involved in this project. I have found it very tempting to ignore the major problems I’ve raised, because of my desire for some of the big names involved in this project to have a crack at the disease. But I simply can’t do so under the present circumstances, I feel the downsides are currently too significant.

It was also very tempting to sit on the fence. This is not the same situation as PACE, for instance. This is not PACE 2. PACE was 100% bad, there were no redeeming features. MEGA, in contrast has both good and bad features. But I felt it was my responsibility to reach a conclusion and to voice it and my conclusion is that there is too much bad wrapped up with the good.

Also, as you can remove your signature from these petitions if you change your mind, if the issues blocking my support of MEGA are resolved — and I hope they are — I will happily withdraw my signature and support the study. That gives me the confidence to make a decision based on the information I have right now.

I welcome comment on my blog from both sides of the debate, it’s not something that patients should fight over, it’s OK to disagree on such important matters. There is no clear right or wrong, and even if we disagree on this I am sure we will continue to agree on a great deal else.

PACE and the interests of trial participants

disabled courtA tribunal has recently ruled that anonymous data from the controversial PACE trial must be released, rejecting an appeal from Queen Mary University of London (QMUL).

The data in question has been discussed on this blog before and you can read here to understand exactly what data we are talking about. It includes no personal identifiers.

The release of this data would allow for a reanalysis of the primary outcome measures according to the thresholds pre-specified in the researcher’s own published protocol. The recovery analysis in their published papers diverged from their own protocol, and included them lowering the recovery thresholds – this had the effect that more patients appeared to “recover” than if they had stuck to the planned thresholds for recovery. It’s possible that against the original recovery thresholds PACE may fail to demonstrate any significant recovery in patients – which would make the trial a failure.

QMUL can potentially appeal the tribunal’s decision and try again to block the release of the data that would allow this analysis. QMUL have already spent over £200,000 on legal fees on this tribunal case alone, which seems extraordinary considering they are a public institution. Following the tribunal’s decision they released this statement on their website: Disclosure of PACE trial data under the Freedom of Information Act

Prior to the tribunal, QMUL released a similar statement in which they said they were “seeking…the advice of patients”: Release of individual patient data from the PACE trial which led me to write to ME/CFS charities asking them to speak on behalf of patients. I asked patients to do the same, and you did! The effort was a success with 29 charities across the globe writing to QMUL on the request of patients to call on them to release the data and drop their appeal. This was submitted to the tribunal as evidence of the public interest in the data being released. Regarding the clear public interest in the release of the data, the tribunal stated:

“There can be no doubt about the Public Interest in the subject matter which is evident throughout the course of this appeal, and beyond, and we are grateful for the assistance that has been given to us in this regard.”

It was surprising that QMUL chose to ignore such strong public interest in the release of the data, which included thousands of patients, patient organizations, and academics. It appears they were not sincere in their wish to take account of the advice of patients, after all and I note that in their most recent statement, this time they do not invite the views of patients. But their most recent statement does say this (my emphasis added):

“We are studying the decision carefully and considering our response, taking into account the interests of trial participants and the research community.”

Perhaps QMUL will be consulting with participants then. QMUL surely do not mean to decide what is in the interests of participants without consulting them? To not consult participants would seem quite remarkable to me, but for all I know QMUL have been keeping participants informed and are seeking their views following the tribunal decision.

Given the Judge has ruled that they “…are satisfied that the risk of identification has been anonymised to the extent that the risk of identification is remote”, and that there is “…a strong public interest in releasing the data…” it is hard to see how QMUL could claim the interests of participants could be furthered by another appeal.

It must never be forgotten that trial participants are also patients, and members of the public too. However, this has not stopped QMUL in its various submissions from making a number of accusations of harassment from patients. In a separate FOI case, under a section they entitled “Harassment,” QMUL have pointed to the 12,000 strong petition calling for PACE claims to be retracted – most of those signatures are patients and some may be from patient participants in the PACE trial.

QMUL has accused patients in their “further skeleton” submission to the tribunal, where they claim “’highly critical’ and ‘vitriolic’ patient/activist groups” have tried to discredit the research.

One such activist group, according to QMUL, is the patient forum Phoenix Rising. Professor Jonathan Edwards, a member of the Phoenix Rising Board of Directors, appears to have been displeased with this accusation, as evidenced by his submission to the tribunal, referred to in the tribunal’s decision:

“Professor Edwards takes issue with the assertions that Phoenix Rising is allowing inappropriate behaviour, and further takes issue with the  term  ‘activist’ being used for its audience. He distinguishes highly motivated data requesters from those acting inappropriately or unreasonably. He accepts that certain individuals have expressed their frustrations with the misinterpretation of the PACE trial on the website in abusive terms, but this pales  in  comparison with four years of “intelligent and measured critique” provided by the other patients. Rather, the campaign to discredit or hijack the issue has come from the PACE authors and their colleagues in a series of attacks in review articles in the national press, online and in public presentations.”

The tribunal decision notice shows that one of QMUL’s arguments against disclosure of the anonymous PACE data was that “It would cause unwarranted distress to participants and open them to criticism or harassment.”

One document submitted by Alem Matthees as part of the evidence to the tribunal was a document collating the publicly available comments from PACE trial participants who had voluntarily come forward to express their views in public. A copy can be found here. It was submitted to dispute the claims of QMUL that patient participants were in danger of being harassed, and shows that in all cases where patient participants have come forward they have not been harassed, but rather have been praised, thanked and supported. This is no surprise, as we are all patients and we all just want to get better.

The Judge, considering this, and other evidence, found QMUL’s assessment of activist behaviour to be “grossly exaggerated” and QMUL were forced to admit at the hearing that “no threats have been made either to researchers or participants.”

But understandably, patients – including patient who are participants in the PACE trial – may feel rather upset with QMUL about their negative stereotyping of patients.

The tribunal decision includes a sentence about the responsibility of QMUL to participants when it comes to information about the anonymous data, the Information Commissioner pointing out that ” It would be up to QMUL to explain to participants that their data has been anonymised so that they could not be identified from it so as to allay fears that they themselves [QMUL] seem to be attempting to stoke up.”

Again, this makes you wonder what QMUL have been telling patient participants, if anything.


 

 

image credit: welsnet
creative commons licence
changes made to original image

PACE Trial’s Forbidden Fruit: AYME Make Final Statement

by-their-fruit

By their fruits you will know them

Following an action from patients asking their representing organizations to support their interests, ten have come out in support by writing to Queen Mary University London calling on them to release the anonymous PACE trial data.

One, the Association of Young People with ME (AYME) ignored patients at first. I wrote them an open letter, and they  finally said they would discuss the issue at their Board meeting in March and make a final statement on the matter. That statement, which I just received by email, is copied below:

QMUL research data: Chair of Trustees states Board’s final decision

In recent weeks, the Board of Trustees of the Association of Young People with ME (AYME) has received requests from individuals within the ME community that they write to Queen Mary University London (QMUL), asking them to release the anonymised PACE data to researchers. At the board meeting, held on the 3 March, the matter was discussed, with the board unanimously agreeing on the following:

The QMUL data has already been released to and reanalysed by the Cochrane Collaboration (perhaps the most rigorous of research teams), which came to the same conclusion as the original researchers. This release to a bona fide researcher who has an ethical duty of care for the data complies with a condition of MRC funding.  For the same reasons, it remains open to other bona fide researchers to request the data, subject to the same ethical undertakings.  Therefore there is no requirement for AYME to write to QMUL and we will not be doing so.

AYME continues to care for, connect with and campaign on behalf of all children and young people affected by M.E./CFS, and this decision is fully in line with our work. No further comment will be made regarding our position on this matter.

M Ellis Chair of Trustees, on behalf of the Board

[to avoid confusion M Ellis is their Chair and is unrelated to myself]

This is a very surprising statement as it flies in the face of patients’ interests. AYME have isolated themselves by taking a stance in opposition to all the other charities. When the PACE data is released, and if it shows that ‘recovery’ was inflated several-fold by the post-hoc changes in recovery criteria then everyone’s first question will be, who took action to keep that a secret? And the second question will be, why?

I will investigate and attempt to answer that second question in my next blog posts. As a patient I cannot accept a charity that has conflicts of interest that trump patients’ interests. It’s time to bring the facts into the light.

PACE Trial’s Forbidden Fruits: An open letter to AYME

sitting-on-fence-1

On 1st February, I wrote to each of the ME/CFS charities in the UK asking them to back patients up in calling on Queen Mary University of London (QMUL) to release anonymized PACE trial data. Lots of other patients joined the effort and contacted the charities too and this was important as collectively we patients can be heard. Most of the charities responded quickly and made public statements that QMUL should release the data. But one of these charities not only did not take action but did not reply to me or other patients I have spoken with.

Despite my chasing them up, the Association of Young People with ME (AYME) ignored my message for over two weeks. I was about to publish this blog post when they finally acknowledged receipt of my message, but their reply failed to address my concerns. I have today sent them the letter that appears below. If you have yet to contact AYME on this issue, I encourage you to contact them to ensure your view is heard. The email address they have requested people contact them on is info@ayme.org.uk .

 

Dear board of Trustees,

As you are an ME/CFS charity I contacted you to make sure you were aware of how I, and many other patients, feel about the importance of anonymous data from the PACE trial being released and asked you to take action in support of patients. A copy of that letter can be found in my earlier blog post. Thank you for acknowledging my original message today, I hope we can have a constructive dialogue on this matter. Largely, I am left guessing at your thinking on these matters, which is unfortunate, but I will address some of the possibilities here in case any of them are relevant to your own considerations.

The value in a letter to QMUL

I stated in my previous letter that “Even if they [QMUL] do not contact you I think you should contact them so that patients’ views are accurately conveyed.” You may be thinking that QMUL would not be likely to submit evidence to the tribunal hearing that does not support their position. A reasonable assumption. However, should you decided to write a letter, and make it public, it could then be used by the side defending the Information Commissioner’s decision that the data be released. It would be a powerful statement of support for a patient who is representing the interests of all ME/CFS patients. So there is no question as to the value of such a letter. I have now reached out to Mr Mathees who has confirmed that a letter would be useful. Should you need to hear from Mr Mathees directly, I can ask him to contact you.

I would also reiterate that QMUL have stated that they are interested in the view of patients, therefore you have a duty to report the consensus among patients and I maintain that a letter to QMUL expressing the desire from patients that the data be released, would be important for them to receive.

No risk of re-identification

Although there are patient participants who are in favour of the anonymous data being released, it is possible that some individual patient participants may have contacted you with concerns, perhaps following contact from those at QMUL who are keen to avoid transparency that would result in further scientific scrutiny. If this has occurred then have you engaged with them to explain that the Information Commissioner considers there to be no risk of re-identification when he ordered the data to be released? Here is a link to his decision notice in which he provides detailed explanations for his decision to reject QMUL’s arguments on re-identification. He is very clear in rejecting the merits of those arguments. If you have not already done so, you must surely take the time to read the decision notice to ensure you can dispel any misinformation patients might hold when contacting you on the matter, and so that you understand these matters yourselves.

The general consensus

As a charity you likely hear a wide range of views from patients, but it would not be appropriate to try and stand behind such a generally true position in this case. Patients’ views have been expressed in an 11,900-signature petition hosted by the ME patient-advocacy organisation #MEAction, which included a call for “the study authors… to give independent researchers full access to the raw data (anonymised by removing trial identifiers and all other data superfluous to the calculation, such as age, sex or location)”, and with the growing controversy over the PACE trial, release would clearly still be in the interests of the vast majority of patients even if a minority were against it. With so many patients and charities all united in their position that the PACE data be released, it would surely be a mistake for AYME to be the only charity not to support that.

Release of anonymous data does not require consent

One of QMUL’s arguments has been that patient participants did not consent to the data, anonymized or not, being released and you may rightly be uncertain as to whether you can call on the data to be released if that would mean consent being broken. The Information Commissioner’s decision notice examines this very question in great detail, about whether or not consent would be broken were this data released. Pages 21 and 22:

(b) Would disclosure of the withheld information constitute an actionable breach of confidence?
70. In order to determine whether disclosure would constitute an actionable breach of confidence the Commissioner considered the following questions:
(i) Does the withheld information possess the necessary quality of confidence?
(ii) Was the withheld information imparted in circumstances importing an obligation of confidence?
(iii) Would unauthorised disclosure cause a detriment to the party providing the information or to another party?
(iv) If parts (i)-(iii) are satisfied, would the public authority nevertheless have a defence to a claim for breach of confidence based on the public interest in the disclosure of the withheld
information?​
The document then provides a summary of QMUL’s arguments put to the Commissioner on this question which is a bit lengthy, and having considered those arguments the Commissioner gives his decision, which I will quote for you here:
75. In order for section 41 to apply it is necessary for all of the relevant elements of the test of confidence to be satisfied. Therefore if one or more of the elements is not satisfied then section 41 will not apply. The Commissioner has explained, in relation to the application of section 40(2), why he does not consider it possible to reliably identify an individual as the subject of the withheld information from its contents or if it is linked with other material available to the general public. In such circumstances he does not consider that there can be an expectation of confidence or that disclosure would cause detriment by way of an invasion of privacy. Therefore it follows that there can be no breach of confidence to action and section 41 does not apply.​
In short: the legal requirements of the Data Protection Act do not apply to anonymised data and so it is not considered “personal data” under law. Therefore no consent is required to release it. It is important that any patient participants are pointed to this information so they understand that it is not personal data that could reveal their identity, and that their consent was not required for anonymized data to be released. Indeed, the PACE authors have already released some of the de-identified data, both in their published papers (individual data on adverse events are given in the appendix of White et al, 2011 and to an outside research team who are currently writing a new paper for publication. So even if we believed QMUL’s masquerade that de-identified data is subject to the consent agreement (which it is not, as has been demonstrated above) then they have already broken that consent agreement at least twice. If any patients have raised concerns with AYME over consent issues have you made the patient participants aware that some de-identified data has already been released without consent being requested by QMUL?

 

Sitting on the fence

Many patients have been in contact with you about this matter by letter and via social media. In your acknowledgement to my message you state:

As the Chief Executive of the Association of Young People with ME (AYME), I acknowledge receipt of your email.

 We will support the outcome of the legal process relating to this action, and are taking steps to add the petition to our website, as soon as possible. The petition will sit in the members-only area of our site and will be available for our members to access as they wish and respond should they choose.

The matter will be further discussed at our next board of Trustees meeting, to be held in early March, and we will issue a further statement after this time.

I presume that this statement is AYME’s interim position as the board have not yet met to discuss this properly. However, as you made this statement I must point out the significant problems with. Your statement is concerning as supporting the outcome of the legal process is the very definition of sitting on the fence. The judges do not require your support. Patients do. As a patient charity you cannot faithfully take an impartial position as you should be committed to speaking up on behalf of patient’s interests in the hope of achieving a better outcome for us. Adopting a passive role would clearly not be a credible outcome in a situation where patients have made their position so very clear.

Additionally, although I welcome the fact you will be putting a link to the petition in your members area, this petition campaign ended some time ago. We don’t need more individual patients to sign the petition, we need charities to back up patients.

If the data are released (only 9% of appeals against the ICO are upheld by tribunals (2014/15 figures) so the ICO’s decision is likely to stand), it is probable that re-analysis will show that recovery rates have been exaggerated several-fold; further critical attention would follow from the scientific community and people will ask who supported the data not being released. There is already a strong and widely held perception that AYME is not on the side of patients and it would be a shame if that perception was reinforced by your inaction. I therefore urge you to publicly ask QMUL to withdraw their appeal of the Information Commissioner’s decision and release all anonymised trial data.

I would suggest that AYME can safely stand behind the ICO’s existing decision, and should do so in the interest of patients. I encourage you to do this in your own interests also. This is a watershed moment for ME/CFS and recent events have put a spotlight on the charities and drawn in many outside observers. The scrutiny of your decision is more intense as you are the last to announce it and anything other than certain support for patients would be in stark contrast with the position of the other charities. Everyone is watching to see what action you take.

Sincerely,
Clark Ellis


Previous posts in this series:
Part 1: Why We Must Be Allowed A Look Inside
Part 2: Is The Data Really Poisonous?
Part 3: Charities Must Echo Patient Calls For Data Release
Part 4: The Fruit Of Your Labour