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:
- Severely affected patients are not well enough to attend the clinics. A few are reached through home visits or telephone/Skype but most do not have this opportunity. If patients come only from the clinics, this very important group will therefore be largely excluded from the study.
- The clinics select patients with the treatments they have to offer in mind (i.e. GET, GAT, CBT). There is therefore bound to be a selection bias towards patients who they believe will respond well to these therapies. This bias may be unconscious but it will inevitably exist. Once again, this will exclude many of the more severely affected patients.
- Some patients will not respond well to the therapies so it is likely they will drop out of the programme. Feedback suggests that such patients are often not followed up by the clinics so they are unlikely to appear in the sample. Once again, these missing patients will tend to be the more severely affected.
- Some patients will have read about the shortcomings and possible dangers of CBT and GET and therefore will not attend the clinics or will refuse their therapies. These patients will therefore not be included if the sample is drawn entirely from the clinics. These are likely to be long term patients and therefore more severely affected.
- Other patients who have been ill for a long time (and therefore likely to be more severely affected) will often have already been to the clinics some time ago and long since been discharged. The clinics tend to offer a series of so many sessions rather than ongoing support. Patient records are only kept for a maximum of five years.
It is vital that the more severely affected patients (falling into both the severe and moderate categories) are included in the sample, so efforts need to be made to reach additional patients through GPs, through patient support groups and through social media. Prof Newton and her team used many of these avenues to find patients for their own severely affected project so they should be able to provide useful advice. The existing ME biobank, which includes samples from the severely affected, should also be an important source of data and it would seem wasteful to ignore it..
We realise that such measures to obtain a broader sample of patients will entail additional cost but I’m sure you will agree that the study needs to be done properly. It is pointless to spend over £5m on an unrepresentative sample of patients which would only provide further misinformation about this condition.
We have several other important concerns about the MEGA study:
2) How are patients to be selected for the patient advisory groups that are mentioned?
We think it important that:
- The expertise should be utilised of the many well informed (and often professionally qualified) patients who are active on social media and the Phoenix Rising forum. Contrary to the ‘scare stories’ circulated by the PACE authors (and roundly dismissed by the recent Freedom of Information Tribunal) these are intelligent, reasonable people who have done much to expose the shortcomings of the PACE trial and whose only aim is to encourage high quality scientific research into ME.
- The confidence of the patient community will not be gained if patient representatives are simply selected by Action for ME, whose credibility among many patients has been severely diminished by their involvement with PACE. (We accept that most of the current leadership of AfME were not in post at the time of PACE but trust once lost can take a long time to regain.)
3) There are numerous references in the 5th Oct ‘questions and answers’ update to the need to limit the amount of data collection if either finances don’t allow or the patient advisory group objects. The issue seems to be overstated and we are concerned that it might be used as an excuse for not developing a Canadian Criteria cohort, which we feel is vital to the success of the study. These fears are amplified by the knowledge that Profs White and Crawley have already made it clear that they consider the Canadian criteria to be ‘not practicable’.
4) The 5th Oct ‘questions and answers’ update reports that patients from the clinics will have been diagnosed with the NICE criteria. However, our information is that at least some of the clinics – possibly more – consider the NICE criteria to be far too broad and they therefore diagnose instead based on their own clinical experience, possibly taking Fukuda into account. So patients from the clinics, though likely to be less severely affected for the numerous reasons given above, will not be a homogeneous sample and this must be taken into account.
5) We believe it is vital, given the nature of the study, to seek out and include patients from families with more than one member affected by the condition.
6) It is also important to include children from more than one source, not just through Prof Crawley who adheres to the now largely discredited BPS model of the condition promoted by PACE. Tymes Trust and social media etc. are other possible sources of young patients.
7) You will be aware that patients have strong objections to the involvement of Profs White and Crawley with this project. We consider these concerns to be totally reasonable given that Prof White was one of the principal authors of the now largely discredited PACE trial which has done so much to hold back legitimate biomedical research and has led to the use of inappropriate, potentially damaging therapies in Britain and worldwide. Prof Crawley, meanwhile, has been a keen adherent of these therapies for the children in her care. Since many of the MEGA team, though distinguished scientists, are new to the field of ME, we feel there is a danger that they may look upon Profs White and Crawley as ‘experts’ in the field of CFS/ME. We feel it is important they are informed that most patients do not regard Profs White and Crawley as experts in ME, merely in their own simplistic and now effectively discredited attempt to explain it away.
Thank you for reading about our concerns which I hope you will feel free to pass on to other members of the MEGA team as appropriate. Unfortunately we will not at present be recommending our members to sign the petition supporting the MEGA trial, but will change this policy if we can be satisfied that the following measures are to be put in place:
- an informed and representative patient advisory group
- a broad, representative sample of patients including the severely affected
- a cohort assessed by the Canadian Criteria
We believe these measures are necessary for the research to make a worthwhile contribution to the growing body of knowledge about ME. I hope you will agree, and that this important study can move forward with more substantial patient support.
P.S. As stated in the above email, we are not advising our members to support the MEGA petition until the important changes suggested above have been made. Many people who have already signed have chosen to remove their signatures for the time being. Instructions on how to remove a signature can be found here.
Naturally other groups and other individual patients will be sending their own communications. While these will have a lot in common, opinion seems to be divided on whether to press for the project to go ahead with changes (as in our own stance) or for it to be abandoned altogether. We understand both points of view but in spite of our reservations it seems wrong to us to pass up on the opportunity of such a potentially powerful biomedical study without doing whatever we can to make it work.
For some, the ousting of Profs White and Crawley from the project will be a ‘make or break’ issue. This is understandable as their presence on the team after all that has happened – especially that of Prof White – is truly outrageous. But from what we can deduce, Prof White’s presence on the team really is only token, while Prof Crawley (unfortunately) appears to be a major driving force behind the project and so is vanishingly unlikely to get kicked off. The latter would be a major cause for concern except that she won’t have control of the lab test results, so as long as the patient advisory group ensures a representative sample of patients, it should be OK.
So we’re holding out for the three issues which we believe are absolutely vital for this project to be worthwhile: a representative sample of patients; a Canadian Criteria cohort; and a strong patient advisory group to ensure that these are achieved. These factors are absolutely necessary to produce a useful and meaningful study so without them MEGA will not have our support.
That’s what we think anyway, though the situation is far from satisfactory. After all that’s happened with PACE, patients really should not be placed in the position of having to make such difficult choices about important future research.
Update: Leeds ME Network received swift replies to the above email from Prof Holgate and Sonya Chowdhury. See the next post for more information.