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: then let all patient organisations and researchers get together and lobby for those necessarily big funds to be made available. With the skyrocketing costs of indefinite medical care, I would say that, no matter what the cost of such a project, it will be tiny compared with the costs of the failure to treat, into infinity.’
Like Steve, I feel that a focus on the severely affected would be a better idea than the sample which is currently proposed for MEGA. On top of the various concerns I’ve covered in earlier posts, the vast numbers proposed for MEGA seem impractical. Prof Malcolm Hooper and Margaret Williams have observed as follows:
‘The PACE trial had to assess 3,158 individuals to find 641 who met the broadest definition of “chronic fatigue” (the Oxford criteria) and who were willing to participate in the study. If the same ratio applies in MEGA, then about 60,000 people will have to be assessed to find the 12,000 said to be necessary to tease apart the presumed subgroups that fall within such a broadly defined cohort. Furthermore, such a large study group severely limits the range and quality of testing that can be applied to each individual due to budgetary constraints. Would a better understanding of the disease not emerge from more in-depth investigations of a smaller but better characterised cohort?’
If we want to study ME, would it not be best to use a sample based on the cardinal ME symptom of PEM? This would tend to focus on the severely and moderately affected patients but exclude those with other fatigue conditions who are more likely to be mildly affected. It would represent the ‘smaller but better characterised cohort’ that Hooper and Williams suggest.
We are told that a broad sample is required for an ‘omics’ study, but surely there is a need to balance this against the feasibility and expense of building such a sample? Is the 12,000 strong sample that has been suggested in the MEGA publicity really either necessary or feasible? From what we already know of the diversity of ME, would not a rather smaller sample of those with PEM still provide sufficient sub-groups to be discovered? Do we learn any more about ME from also including patients with other forms of fatigue – or do we just generate more expense?
Prof Chris Ponting of the MEGA team explained in the comments on his blog on the Change.org site: “adding a person who clearly does not have ME/CFS will reduce the study’s power”. So presumably the study’s power would be reduced by the patients with other fatigue conditions who would inevitably be included in the sample from the clinics which has been proposed. Prof Ponting adds further: “ The selection of individuals for this study is critical and all that I have heard on this makes me believe that post-exertional malaise criteria should lie at the heart of this. The patient advisory groups that will be set up need to have a strong voice on this issue.” I don’t think any of us will argue with that.
But how to obtain these patients with PEM that Prof Ponting is so clear that we need? Prof Jonathan Edwards has suggested we follow the lead of the existing UK Biobank. He says: ‘The Biobank recruited not from clinics but from primary care. That has the advantage that it picks up everyone in a defined population who is known to the GP to have ME. If someone is not known to the GP to have ME they are not going to be at a clinic either but there will be lots of patients that the GP is aware of but who do not attend clinics. As I understand it the patients were also vetted by a nurse specialist dedicated to the project to ensure that they conformed to various sets of criteria.’
So that’s it then. That’s what we do. I don’t know how big the sample size needs to be but it will be less than the original 12,000 because it won’t include the patients with other fatigue conditions who would be present in the sample from the clinics. The existing biobank has 500 patients to make a start with plus funding to expand. So testing could start right away (at least in a small way) which is more than could be said with the original proposal. So why not get this underway? It’s time to get together and sort this out and get this bird up and flying…