By David Tuller, DrPH
The National Institutes of Health is making a $2.1 million grant to the UK ME/CFS Biobank–a huge endorsement of this important project run by CureME and housed at the London School of Hygiene and Tropical Medicine. Hereâ€™s what the ME Association wrote on its website:
â€œThe funding represents the biggest ever single investment in biomedical research to happen in the UK and it will enable a current project, that is searching for disease biomarkers, to be extended for another 4 years â€“ until 2021.
The project is a longitudinal study that is measuring changes in the immune system and genetic profile of individuals in a disease whose symptoms are known to fluctuate over time. The initial Â£1 million project, which began in 2013, was over 3 years and had also been made possible by funding from NIH.â€
The announcement comes a few weeks after the annual conference of the CFS/ME Research Collaborative, which has backed a parallel project called the ME/CFS Epidemiology and Genomics Alliance (MEGA). At the CMRC gathering, the organizationâ€™s chair, Professor Stephen Holgate, extolled his colleague, Professor Esther Crawley, for her â€œamazingâ€ and â€œstunningâ€ work on MEGA–even as he announced that the project had failed its recent bid for funding from the Medical Research Council.
The MRC rejection followed Wellcome Trustâ€™s rejection of an earlier MEGA application. But this second decision was particularly surprising, given that Professor Holgate himself has longstanding ties with the MRC. An MRC representative also sat on the CMRCâ€™s executive committee. That the agency chose not to fund MEGA was clearly an unwelcome public embarrassment for the CMRC, Professor Holgate and Professor Crawley.
In his remarks, Professor Holgate tried to mitigate the negative impact by promising that MEGA would regroup, learn from the MRCâ€™s comments, and pursue other funding opportunities. In particular, he highlighted the organization’s upcoming meeting with Vicky* [corrected from Vicki] Whittemore of the NIH as an exciting opportunity–raising the expectation that this event might lead to positive developments for the CMRC and its pet project.
Vicky* [corrected from Vicki] Whittemore â€œhas taken a great interest in what this collaborative is doing, and wants to talk to us about how we can…form collaborative initiatives between the National Institutes of Health and the researchers here in UK,â€ Professor Holgate noted in his remarks. â€œWhat shape that might look like and where it goes I donâ€™t know because we havenâ€™t had the conversation yet, but the mere fact that sheâ€™s giving up a whole morning to meet with us…is incredibly encouraging, and weâ€™ll let you know how it all goes.â€
Now we know how it all went. The NIH is funding the UK ME/CFS Biobank.
Earlier today, I sent the following e-mail to Professor Holgate (and other members of the CMRC executive committee), seeking comment on this exciting new funding development:
â€œAt your opening remarks at the CMRC conference, you mentioned that the group would be meeting soon with Vicki [sic] Whittemore of the National Institutes of Health. You called the prospect of having the meeting and exploring collaborative initiatives ‘incredibly encouraging.’Â
You presumably hoped, when you announced the upcoming meeting, that the NIH would take an interest in the CMRC and MEGA. Since MEGA’s grant applications to two major UK funders–the Wellcome Trust and the Medical Research Council–were both turned down, it makes sense to regroup and seek links with a large overseas funding agency like the NIH.Â
Given that context, I wonder if you (or anyone on the executive committee) would like to comment on the announcement that the NIH is providing $2.1 million to the UK ME/CFS Biobank, at the London School of Hygiene and Tropical Medicine. That is obviously a huge investment in biomedical research and a major endorsement of the UK ME/CFS Biobank’s vision and leadership. So:
Why do you think the NIH chose to provide such substantial support to the UK ME/CFS Biobank? Are you surprised at the NIH decision, or did you learn about it in the meeting that took place after the CMRC conference? Has the NIH given any indication that it might offer CMRC and MEGA similar support in the future?Â
And a few more questions: Given the CDC’s recent “dis-endorsement” of the CBT/GET treatment approach to ME/CFS, do you think NIH officials are likely aware of the international uproar over the conduct and findings of the PACE trial and related biopsychosocial research? Do you think US public health officials might be reluctant at this point to fund investigators who are firmly associated with the CBT/GET camp and who declare PACE to be a “great, great” trial?Â
Furthermore, do you think US public health officials might be reluctant to fund investigators who believe patients seeking access to public information are “vexatious,” or who publicly advise other researchers how to avoid their obligations under British freedom of information laws? Do you think US public health officials might be reluctant to fund investigators who make false accusations of “libellous blogging,” and then refuse to either provide evidence for the charge or apologize? Do you think they might be reluctant to fund organizations that affirm “full support” for investigators who engage in such behavior?Â
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As before, I have not included Professor Crawley in this e-mail, since I am aware that she considers messages from me unwelcome. However, I would of course be pleased to post any comment from her about this issue. It goes without saying that I would also still welcome any explanation or documentation of her accusation of “libellous blogging.” So please feel free to forward this e-mail to her!â€
Since MEGA first came about my feeling has been that the psychobabblers were afraid that Nacul’s biobank, using the CCC for participant selection for the biobank and research, was a threat to their papers based on Oxford or less. So they came up with the MEGA idea to make their own biobank of anyone tired. Really glad MRC finally didn’t back them, and biomedical research prevailed!
Anton Mayer says
One of the goals of MEGA was presumably to ensure funding and access to patient data for BPS oriented projects.
Diane Kirk says
Love this, David!
CMRC a funding vehicle for Crawley who is second behind White in MRC funded research
I do love those emails to Stephen Holgate & co. 🙂
Lady Shambles says
I’m very glad Vicky Whittemore presumably had the intelligence to use the information she had gleaned from her attendance at recent Invest in ME Conferences to best use, enabling her to assess where the genuine collaborations reside and where those with a vested interest (which are not in the interest of pwme) play their little games. I sincerely hope she continues in this vein and never uses her position to encourage the NIH to fund MEGA at any point in the future, or fund any projects associated with any personnel of the ‘BPS’ variety.
I am pleased to hear that Nacul et al are endowed with this recent NIH grant which can extend their work for the next 4 years. However if they are reading this I would implore them to tag an extra criteria option to their cohort, this being the ICC, (of which I know they are aware having used it as a reference in a recent article) to bring them into line with other researchers who are presently using it as well as attracting the gratitude of patients internationally who see ICC as the best standard for properly defining authentic ME.
Joan Byrne says
Its a tonic reading these blogs David. I do hope Mr. Holgate responds to your very valid questions. I’m sure there are many that would like to see that response. I do hope he passes your email on to Ms. Crawley too. I can’t help feeling he really should be encouraging her to become more widely read. It’s not a good thing to be stuck in a bubble because we all know that bubbles eventually burst. Perhaps those standing beside her should consider the fallout from such a burst. They might be wise to take cover now….
Anil van der Zee says
Rub it in haha
I am not surprised that the MEGA project has not been funded if, as I assume, it is for a genome-wide association project which is unlikely to have any impact on the understanding of ME.
You need large numbers of patients and matched controls to make it worthwhile, but most gene variants found in genome-wide association studies are in genes that do not code for proteins, and most have a very small effect on the disease. The studies done in other diseases, such as diabetes and arthritis, comprise a small proportion of the research activity, and the results may complement the research findings from hundreds or thousands of studies using other techniques. In contrast, there has been relatively little research into ME (particularly in the UK). Because of the paucity of research, it makes no sense to spend money on an activity that is unlikely to yield useful results. And, without the groundwork of research that directly investigates the biological mechanisms underlying the symptoms, there is a lack of basic understanding of the disease necessary to guide and interpret a GWAS project. It is not surprising, given who is involved in MEGA, that the approach is so misguided.
The LSHTM Cure ME Biobank project is a complete contrast, working from the ground up, using multiple techniques from different disciplines to learn more about the disease, which is exactly what we need. I am delighted that the NIH has awarded this funding.
Erik Johnson says
It might just be that the NIH understands that the real problem is environmental, investing in a biobank would be a terrific diversion.
It would create the impression that they are doing something, when in reality it would sideline investigation into things like the Sick Building Syndrome connection to CFS.
Erik Johnson says
I do understand that the ME/CFS community wants all the early history of the CFS syndrome, from 1984 through 1994 at least, to be eradicated.
I don’t know why, but every attempt to talk about the old evidence creates a totally adversarial “hostility” response of antipathy or dead silence.
This information could have been useful, but the desire to have it all disappear is massively evident.
Jerrold Spinhirne says
The question of what criteria will be used to select subjects, or samples, and what the disease, or condition, studied is called still remains critical. If the disease studied is not called “ME” (myalgic encephalomyelitis) and subjects are not selected using ME research criteria (the ME-ICC) exclusively, can a study be considered ME research?
Chronic fatigue is not a characterizing symptom of ME, or required for its diagnosis. How then can research on subjects characterized by fatigue (chronic, persistent, profound, recurrent, etc.) and required to have reported 6 months of unexplained chronic fatigue be considered ME research?
We have yet to see contemporary research on subjects who unequivocally have ME with their disease called solely “ME” â€“ without an extraneous fatigue-based condition attached to its name.
As someone who has closely followed research in the field for many years, I find the alphabet soup of various sets of criteria used, often in a single study, very confusing. I can’t imagine what journalists, doctors, and the general public make of them.
I think it harms the credibility of ME as a distinct, serious neurological disease not to have the ME-ICC used exclusively for ME research, or to have the ME-ICC placed among various sets of conflicting fatigue-based criteria. The ME-ICC do not require fatigue as a symptom and call for ME to be removed from the various overly inclusive groups selected by other criteria.
As the 2012 IC Primer states:
“It is counterproductive to use inconsistent and overly inclusive criteria to glean insight into the pathophysiology of ME if up to 90% of the research patient sets may not meet its criteria (Jason 2009).”
“Research on other fatiguing illnesses, such as cancer and multiple sclerosis (MS), is done on patients who have those diseases. There is a current, urgent need for ME research using patients who actually have ME.”
Its great you are persuing the truth of this and asking the uncomfortable questions David, thanks, its a breath of fresh air.
Fallout can take many forms it seems and the extent is only just beginning to be realised!
Joan, how true, “Perhaps those standing beside her should consider the fallout from such a burst. They might be wise to take cover now…. ”
I think this has already happened; with one key EC colleague (formally based at Bristol University) responding to my information inquiry on the CMRC and the National Outcomes Database (NOD), stating , “I am no longer working in the field of ME and CFS research, so I am sorry I can be of no further help to you.”
I was also told the “NOD” has not been operational for 2 years, due to funding problems; not all 27 clinics who had registered as members of the Collaborative did returns reliably; some not at all, thereby (they said) rendering the Collaborative Database NOD unreliable for research use. …hum.?
Yet our Local Clinic cite the Collaborative and NOD initiative to be a crucial part of their daily ongoing work and a key objective measure of their success! The fact that they are wasting patient’s precious energy completing copious complex repetative forms, then “uploading them” to something that is defunct now and non operational makes me wonder if service and clinical management and fit for their job! As for the criminal waste of precious service monies or data protection of the information ……?
Joan,how true, “Perhaps those standing beside her should consider the
fallout from such a burst. They might be wise to take cover now…. ”
Fallout can take many forms it seems and the extent is only just beginning to be realised!
I think this has already happened; with one key EC colleague (formally
based at Bristol University) responding to my information inquiry on the
CMRC and the National Outcomes Database (NOD), stating , “I am no
longer working in the field of ME and CFS research, so I am sorry I can
be of no further help to you.”
I was also told the “NOD” has not
been operational for 2 years, due to funding problems; not all 27
clinics who had registered as members of the Collaborative did returns
reliably; some not at all, thereby (they said) rendering the
Collaborative Database NOD unreliable for research use. …hum.?
Yet our Local Clinic cite the Collaborative and NOD initiative to be a
crucial part of their daily ongoing work and a key objective measure of
their success! The fact that they are wasting patient’s precious energy
completing copious complex repetitive forms, then “uploading them” to
something that is defunct now and non operational makes me wonder if
service and clinical management and fit for their job! As for the
criminal waste of precious service monies or data protection of the
……’was” I think is now the order of the day?!