Natalie Boulton – MEGA PAG

I applied to join the MEGA PAG believing that the public specification for the patient advisory group was a serious commitment to ME patients and to PAG members – at least until a more comprehensive Terms of Reference was agreed with the PAG. I also believed that the information given to Forward ME by Prof Holgate, to allay concerns expressed by the Countess of Mar and ME charities about MEGA, could be depended on.

I now find, almost three months since the PAG was formed, that both this public commitment and Prof Holgate’s answers have turned out to be misleading. Furthermore, no terms of reference have been agreed, to enable the PAG to operate effectively, despite this being a priority, and the minutes from the only meeting held while I was a PAG member ( last December) have still not been confirmed or made public.

I am, therefore, concerned that patients and ME charity representatives have been misled. In my view, over the last three months, the PAG has not been permitted to carry out the functions publicly ascribed to it. As an advocate for severely ill ME patients this puts me in a difficult position. Members of the PAG have been working and studying incredibly hard, both individually and collectively, in order to be in the best and most informed position to assist the MEGA team who, as a group, have very little knowledge of ME/CFS. I believe we are all desperate for good quality, relevant research to be done on ME and ME/CFS, so I have found it intensely frustrating to find our efforts to engage thwarted at every step. I have not felt that the PI representing the MEGA researchers has a genuine wish for a meaningful engagement with the PAG, nor for the collaborative relationship many PAG members hoped for and have been working towards. Now, sadly, my impression is that the PAG was hastily appointed at the last minute as a cynical attempt to try to make bioresource bids look more appealing to funders and to reassure patients.

I have not found an honest and open environment for discussion between PAG and PI. At the only official PAG meeting before I resigned, it became clear that critical design issues for the MEGA project had already been decided upon and were non-negotiable: no meaningful discussion of these issues would be permitted. All further research by MEGA researchers, whether a broad ranging Genome Wide Association Study or more in-depth research, will depend on the samples collected for the MEGA biobank, so the selection and identification of patients is crucial, as Prof Holgate and others including Prof Davey Smith have pointed out.

At her recent inaugural lecture, the PI made clear her understanding of ME/CFS in children as being a very common condition, responding very positively to the behavioural management regimes found to be so flawed in adults. She also expressed grateful thanks for the assistance that she has received from Profs. Peter White and George Davey Smith over the last 10 years, with helping her win research funding. Peter White is the psychiatrist who led the PACE Trial. George Davey Smith is an excellent researcher, but says he knows nothing about ME/CFS, even after 10 years of being associated with CFS research as Bristol University. As a PAG member I have seen no evidence that the MEGA biobank PI is willing to allow those who have lived with and developed a more realistic understanding of the severe illness known as ME, to engage in meaningful discussion about the selection of patients and to listen to our concerns about the potential danger of particular groups being under-represented in the biobank and even in a GWAS.

ME has a long history of definitions and criteria being used in a very ‘creative’ manner.
I decided a couple of weeks ago that, as an advocate for those with severe and long lasting ME, I could no longer remain a PAG member in a project whose value to ME patients:
1. relies entirely on how a few significant terms – such as PEM – or ME/CFS – will be defined at some future date
2. where crucial decisions, which will impact on future options, were made without any in-depth discussion being permitted
3. where no working relationship or discussion has been allowed between the PAG and MEGA researchers.

Since impending resignations were known about, there seems to have been a frantic attempt to placate criticism from the PAG, but this does not restore my confidence in the overall MEGA biobank project.

There has been a history of legitimate patient concerns being dismissed as harassment and persecution, even when these concerns are raised at terrible cost to patients own health. I hope that researchers, patients, carers and ME charities will recognise the legitimacy of the serious concerns raised by the resigning PAG members, rather than dismissing them and relegating them to the ’persecution of brave researchers by nasty patients’ narrative.