Getting Airborne

Steve Hawkins, who often comments here at the blog and quietly does a lot of useful activist stuff behind the scenes, left the following comment/proposal on the OMEGA petition site (and added it here in response to the previous post). I thought it was worthy of a wider audience so I’m reposting it here to kick off today’s blog:

‘It seems unfortunate that there has to be a petition of this kind against what, in the right hands, and with careful preparation of protocols in advance, would undoubtedly be a gathering of very useful data; and I feel uncomfortable that this will discourage some of the very able researchers and research teams who have been brought into the MEGA group but had no part in earlier ill advised research proposals; but it seems that something of this sort will have to be done, to ensure a complete new start, and clean break with the discredited ‘science’ of biopsychosocial egotists.

‘I apologise to the, well-meaning, I’m sure, Prof. Holgate, and those others who I fear have had to be reticent in criticising poor research, because of the binding conditions that were attached to membership of the Research Collaborative, under the direction of the partisan ‘Science Media Centre’, but the time really has come to return to both freedom of speech and information in this research field, after the gambit of crying ‘harassment’ after any honest questioning, has been so clearly shown up for what it was, in the courts.

‘I would advise that a new steering group be set up for a large and inclusive, data gathering and biomic sequencing and typing study with the major emphasis on the severely affected, who are the most likely to yield clear differences worthy of more intensive study. By all means collect data from a quota of less severely disabled/sick patients as well, but only to the number necessary to provide a control match for each of the seriously ill study subjects. A similar number of healthy controls will also be needed.

‘Thus the size and expense of the study should stem from the maximum number of seriously ill participants for statistical certainty… (plus controls). If that turns out to be a very big cost Continue reading “Getting Airborne”

More on MEGA

Following on from their original email and Professor Holgate’s response, Leeds ME Network have sent a further email to Prof Holgate of CMRC about concerns regarding the proposed MEGA project:

Many thanks for your swift response to my previous email regarding the MEGA study and for passing our concerns on to those who are preparing the bid for funding…

It is heartening to hear from your email that the inclusion of very severe patients is under discussion by the MEGA team. I notice, however, that you mention ‘financial limitations’ in this context. The reaction of other patients with whom I have shared this issue echoes my own: that severely affected patients should be the priority. People with ME/CFS in general are offered little in the way of treatment but most of the severely affected are abandoned entirely by doctors. They are left to lie in darkened rooms, often unable even to sit up in bed or converse with their loved ones, and without any prospect of medical intervention. I’m sure you know all this. Though I cannot claim to have taken a scientific sample of opinion, the overwhelming impression I get from patients is that if there are financial constraints regarding MEGA then these should apply to the overall number of samples taken rather than be focussed on the severely affected, who are the ones most in need of help. I am reminded of Prof Ron Davis’ observation that data from severely affected patients is the most important ‘because their biology would show the greatest differences compared with healthy controls’. It seems incongruous to be envisaging such an enormous study yet even at this stage, while the grant submission is still being prepared, to be talking about insufficient money for full inclusion in the study of those most in need of help.

A further issue regarding patient selection occurred to me while reading through the ‘questions and answers’ update on the MEGA petition website:

The update says: “The only way to do this is to recruit patients through NHS clinics throughout England.”

As I described in my previous email, taking patients from the clinics alone would produce a sample of patients biased towards the less severely affected. Continue reading “More on MEGA”

Some Response from MEGA

Following yesterday’s emails to Prof Holgate, Chair of the CMRC, and Sonya Chowdhury of Action for ME, Leeds ME Network has received short responses from both of them including a bit of encouraging news.

Prof Holgate said: “The preparation of the initial outline for this grant is very much ongoing. I am sure the applicants will be as inclusive as possible, and I am already aware of a discussion of how to include very severe house-bound patients. Finance will be a limiting factor.” He says he will pass the email on to those involved in preparing the grant outline.

Sonya Chowdhury said she would leave it to Prof Holgate to respond on behalf of MEGA but was able to confirm the following:“There has never been any suggestion that individuals for the patient advisory group will be Action for ME recruited; indeed I believe I have tweeted to this effect. We completely expect the group to be representative and recruited transparently.”

So, two pieces of encouraging news: about the housebound patients and the recruitment of the patient advisory group. I’m a bit concerned, though, about yet another mention of the limitations of finance when the severely affected are mentioned. This is a massive study with 12,000 patients seeking finance in excess of £5m. Surely with so much invested, we can make sure that the severely affected are adequately represented…

Making the Most of MEGA

In an earlier post, I published an email from Leeds ME Network to Sonya Chowdhury, CEO of Action for ME, expressing reservations about the presence of Profs White and Crawley on the team of the proposed MEGA biomedical research project. Here is the latest update from Leeds ME Network:

In response to our letter to Sonya Chowdhury, we have just received what appears to be a standard letter referring to the latest updates on the MEGA petition page at Change.org. Leeds ME Network have now responded in turn with the following email, slight variations of which will be sent to Ms Chowdhury; Stephen Holgate the CMRC Chair; Dr Charles Shepherd at ME Association; and ME Research UK. Our email follows:

We are grateful to the MEGA team for letting us know about the proposed CFS/ME biomedical research project. We believe it is very important that this study goes ahead but in view of some of the less than helpful research which has taken place in the past (in particular, of course, we are thinking of the PACE trial) we hope you will understand why we patients are keen to voice our concerns about the proposal.

1) The impression has been given that patients for the study group will all be drawn from the NHS Clinics. It seems clear that such a sample would be heavily biased towards less severely affected patients and that the sample would therefore be unrepresentative of the total patient population.

The reasons for this are as follows: Continue reading “Making the Most of MEGA”

A Broader Picture

The last draft post I wrote about the MEGA petition was superseded by events before I finished it, so I’ll try and crack on with this one before the same thing happens again. Of course ‘cracking on’ in ME terms is still kind of slow but I’ll see if I can break the tortoise barrier.

So, what’s happened recently?

Well, we’ve been told that Peter White is retiring from research and will only be an ‘advisor’ to MEGA from now on. This perspective appears to be endorsed by the latest list of MEGA personnel, which no longer includes him. I can only give a muted ‘hurrah’ to this one. Advice is dangerous stuff and you can still do a lot of damage with it. His PACE Trial is swiftly becoming a watchword for bad science (see here, here, and here). Is he really the sort of ME ‘expert’ that either we patients or the MEGA team want around to guide this latest project?

It really is astonishing that MEGA apparently do still want him around after all he has done, and that they clearly expect patients to put up with it. It seems to me that if a passing Martian was given a brief course in English and the full facts, then even he (or she) would swiftly understand why we don’t want Prof White anywhere near this project. Why do the MEGA team not get this?

People with ME have  been left on the scrapheap for decades. I myself have been ill for over thirty years. That’s over half my life. I have no children because of it. I lost my job. My life is very limited. Yet I am one of the relatively lucky ones. I can sit and tap at this keyboard – as long as I take plenty of rests to fend off the shoulder and eye pain and overall exhaustion. There are plenty of others who have to spend all their lives in bed, who can’t stand the light, who can’t even talk to their loved ones. We’ve all heard about Whitney Defoe whose birthday it recently was. He is not alone in his suffering. The vast majority of the severely ill are left to fend for themselves as best they can. Rarely do doctors come near them and they wouldn’t know what to do if they did.

And all this time, all these decades, so little research has been done, in large part because of the fairy story dreamed up by the PACE researchers and their associates: the fairy story that Continue reading “A Broader Picture”

Not Looking Good So Far…

A few preliminary thoughts and questions come to mind in response to the latest update on the proposed MEGA Trial.

  • Question: How are patient advisory groups to be recruited?
  • The update says:

How much data we collect will depend on what our patient advisory group says will be acceptable to consenting patients and how much funding we get.

I’m concerned that this will be used as an excuse not to develop the very important Canadian Criteria cohort – Profs White and Crawley have already decided that the Canadian Criteria are not practicable

  • Clinicians who diagnose at the NHS clinics can often be OTs, nurses etc. Some of these may be very good but some have very little experience of ME/CFS. It seems inevitable that they will be focussing on what they believe to be the key symptoms of ME/CFS and not necessarily taking a full and complete history.
  • We know from experience that NHS notes in general can be inaccurate as often as not.
  • What about the severely affected who can’t get to clinics? Some clinics provide a limited home visiting service or skype/telephone consultations  but the vast majority of the severely affected do not receive these services and so will be excluded from the trial. As Prof Ron Davis says, the severely affected provide the most important data.
  • There is circumstantial evidence that many patients are rediagnosed by some of the clinics as having ‘pervasive refusal syndrome’ or ‘illness anxiety’ or some other ‘psychogenic’ condition if they don’t make progress with GET or GAT or if the clinic doesn’t think they will make progress. These patients may be at the more severely affected end of moderate so their elimination will skew the cohort.
  • Similarly, we know that many patients who drop out of therapy are not followed up on. It seems likely that these will not be included in the project, so once again the cohort will be skewed.
  • The update says:

We don’t think we will have the money to do this for everybody or for everything.

This is already sounding a bit half-baked. We’ve had enough such research. Isn’t it better to set out to do less and do it properly?

  • The clinics in general subscribe to the biopsychosoial model of the illness. Given what has happened with the now largely discredited PACE Trial, it is understandable that informed patients  will be mistrustful of a study which has the NHS Clinics at its heart. In its presently proposed form and on first reading, this project seems to me to be unlikely to obtain the support of the whole ME/CFS community.  This is unfortunate and I hope that another way of proceeding can be found.

MEGA Update

Here’s the latest from the MEGA petition site:

3 Oct 2016 — Two members of the Alliance have retired from the group: Simon Collins, University of Bristol, will be changing universities; Prof Peter White, Queen Mary University, London, is retiring from research at the end of this year and will have an advisory role.

We will be launching a series of blogs this week from MEGA members outlining why they joined MEGA and what their expertise and field/discipline has to offer.

Which doesn’t seem to me to make a whole lot of difference unfortunately. It does make you wonder why, after the PACE trial, anyone running a research study would want to take advice from Peter White… And Esther Crawley remains involved. The other day, at the CMRC conference, she was seeking to justify her use of GET on children by saying there is ‘good evidence that it works for adults’. It doesn’t seem like she’s paying much attention to the recent slippage in the reputation of PACE.

Previous posts related to MEGA:

MEGA Petition

Unsigning

Barefaced