CFS - research plans - PACE flaws action taken future research- more mental health practitioners? Any biomedical research by biomedical experts?

The request was partially successful.

Dear Medical Research Council,

I am seeking information on:

a) MRC's investigations into the flaws in the PACE trial and the misleading claims made by the authors/advisers ( Simon Wessley, Peter White, Trudie Chaldler and Micheal Sharpe).
See http://me-pedia.org/wiki/PACE_trial

Minimal (if any) objective measures of outcomes; use of entry criteria (rejected in the USA) so broad that the study includes people with mental health disorders and not ME/CFS; setting/changing outcome measures after the data has been seen; conflicts of interest with insurance companies.

b) Plans by the MRC to fund any further studies into ME/CFS, in the next 5 years, led/influenced by the above mental health practitioners and/or Ester Crawley (another mental health practitioner) whose trials show the same pattern of flaws.

c) Plans by the MRC to fund biomedical studies, in the next 5 years, led and implemented by biomedical experts from relevant fields e.g. biochemists, geneticists, neurologists, neuroimmunologists.

Yours faithfully,

George Jenson

National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
Objective:
The primary objective is to explore the clinical and biological phenotypes of post-infectious myalgic encephalomyelitis/chronic fatigue syndrome (PI-ME/CFS). The secondary objective is to explore the pathophysiology of fatigue and post-exertional malaise (PEM).

Design:
This is a single-center, exploratory, cross-sectional study of PI-ME/CFS. Participants will have a phenotyping visit, which will encompass a 2-5 day long inpatient admission at the NIH Clinical Center. Case status for ME/CFS participants will be determined after the phenotyping visit by a case adjudication process utilizing an expert physician committee and published guidelines.
Adjudicated participants meeting inclusion criteria will be invited back to participate in an exercise stress visit, which will encompass a 5-10 day long inpatient admission. Detailed subjective and objective measurements and biological specimens will be serially collected before and up to 96 hours after a peak exercise test capable of inducing post-exertional malaise during this visit. All procedures will be completed on all three study groups to allow for optimal inter-group comparisons.

Outcome measures:
Characterization of the immune system and inflammatory signaling in blood and cerebrospinal fluid (CSF)
Characterization of the pattern of microbiome in gut, blood and CSF
Characterization of physical and cognitive fatigue using functional magnetic resonance imaging and transcranial magnetic stimulation
Effect of maximal exertion on neurocognition
Effect of maximal exertion on brain function and connectivity
Effect of maximal exertion on markers of immune dysfunction and inflammation
Effect of maximal exertion on metabolic function
Effect of maximal exertion on autonomic function
Effect of maximal exertion on gene expression profiles in blood and CSF
https://clinicaltrials.gov/ct2/show/NCT0...

Dear Mr Jenson,

 

MRC Reference FOI 2016-046

 

Thank you for your Freedom of Information request. We will investigate
what information is available and respond in due course.

 

Yours sincerely,

 

Corporate Affairs Group

Medical Research Council

 

www.mrc.ac.uk

 

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Dear Mr Jenson,

 

MRC Reference FOI 2016-046

 

Thank you for your Freedom of Information Act request of 13 December 2016
in which you asked questions relating to the PACE Trial and the policy of
the Medical Research Council (MRC) relating to the funding of research
into Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME). 

 

I will answer your questions in turn.

 

 

Question 1: MRC's investigations into the flaws in the PACE trial and the
misleading claims made by the authors/advisers ( Simon Wessley, Peter
White, Trudie Chaldler and Micheal Sharpe).

See  [1]http://me-pedia.org/wiki/PACE_trial   

Minimal (if any) objective measures of outcomes; use of entry criteria
(rejected in the USA) so broad that the study includes people with mental
health disorders and not ME/CFS; setting/changing  outcome measures after
the data has been seen; conflicts of interest with insurance companies.

 

The PACE Trial (A Randomised Controlled Trial of CBT, graded exercise,
adaptive pacing and usual medical care for the chronic fatigue syndrome)
was funded between June 2004 and May 2011 through a grant to Queen Mary
University London (QMUL).

 

The MRC has not undertaken a formal investigation of the PACE Trial. 
However, the MRC has received correspondence raising detailed questions
and concerns about the study which we have responded to. An example can be
found at [2]http://www.investinme.org/Article400%20M...

 

The MRC requires the host research organisation to have mechanisms in
place to investigate concerns relating to the studies we fund. Thus, any
concerns relating to the PACE trial should be raised with QMUL to enable
them to investigate and respond directly.  Investigations of complaints
about specific individuals would be a matter for their employers.

 

 

Question 2: Plans by the MRC to fund any further studies into ME/CFS,  in
the next 5 years, led/influenced by the above mental health practitioners
and/or Ester Crawley (another mental health practitioner) whose trials
show the same pattern of flaws.

Question 3: Plans by the  MRC to fund  biomedical studies, in the next 5
years,  led and implemented by  biomedical experts from relevant fields
e.g. biochemists, geneticists, neurologists, neuroimmunologists.

 

Research into CFS/ME is a current MRC priority area. We welcome
applications into all aspects of the condition and also have a Highlight
Notice in place, which identifies specific areas of CFS/ME research where
proposals are particularly encouraged. Highlight Notices aim to encourage
applications in areas identified by the research community to increase
research capacity and bring together multidisciplinary teams to tackle key
research challenges in the area(s) identified. The priority areas
identified in the current CFS/ME Highlight Notice for researchers
emphasise the need to understand the mechanisms underlying chronic changes
related to CFS/ME. This includes:

-             Immune dysregulation.

-             Pain.

-             Improved sub-phenotyping and stratification of CFS/ME.

-             Mechanisms of CFS/ME in children.

-             Neuropathology.

 

Applications for MRC funding are generally submitted by the research
community in ‘response mode’. Thus, while we welcome applications
addressing all aspects of a disease or a health condition, we do not
normally commission research or invite proposals on specific projects or
from individual researchers.

 

Thus, we have no specific plans, but would consider any proposals
submitted under our normal mechanisms.

 

Further details of the Highlight Notice can be found at:
[3]http://www.mrc.ac.uk/funding/how-we-fund...

Further details of how research proposals are assessed and how funding
decisions are made can be found at:
[4]https://www.mrc.ac.uk/funding/how-we-fun....

 

 

I hope that this information answers the questions that you have.  Please
do contact me if you require any clarification, or have any further
questions.

 

I hope you are satisfied that this response has been handled
appropriately; if not you may appeal using the MRC's complaints procedure.
Details are on the MRC website at:
[5]http://www.mrc.ac.uk/about/information-s... You may
contact the MRC Complaints Officer at:

 

The Complaints Officer,

Medical Research Council,

14th Floor, One Kemble Street.

London,

WC2B 4AN.

email: [6][email address]    

 

If you remain dissatisfied with the handling of your request or complaint,
you have a right to appeal to the Information Commissioner at:

 

The Information Commissioner's Office,

Wycliffe House,

Water Lane,

Wilmslow,

Cheshire,

SK9 5AF.

Telephone: 0303 123 1113.

Website: [7]www.ico.org.uk   

 

There is no charge for making an appeal.

 

Yours sincerely,

 

Rosa Parker

 

Corporate Information and Policy Manager

Corporate Affairs Group

Medical Research Council

 

[8]www.mrc.ac.uk

 

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Dear foi,

Thank you for your response. Unfortunately the link provided does not work.

Could you please advise how I can access the information.

Yours sincerely,

George Jenson

Dear Mr Jenson,

 

MRC Reference FOI 2016-046

 

Thank you for bringing this to my attention.

 

I have checked the response that I sent and found that the links did work,
but when I went to the version that was published on the What Do They Know
Website I found that one of the links (the example of correspondence that
we had responded to) was not working. 

 

Here are the full set of links that I provided in my response to you, both
in full, text only (to copy into your browser), and in shortened link
format.

 

1. Link to an example of correspondence that the MRC has responded to:

[1]http://www.investinme.org/Article400%20M...

investinme.org/Article400%20Magical%20Medicine.htm

[2]Correspondence example

 

2. The MRC CFS/ME Highlight Notice:

[3]http://www.mrc.ac.uk/funding/how-we-fund...

mrc.ac.uk/funding/how-we-fund-research/highlight-notices/cfs-me-highlight-notice/

[4]MRC CFS/ME Highlight Notice

 

3. Information on how the MRC funds research:

[5]https://www.mrc.ac.uk/funding/how-we-fun...

mrc.ac.uk/funding/how-we-fund-research/

[6]How the MRC funds research

 

4. The MRC complaints policy (which includes the contact e-mail address):

[7]https://www.mrc.ac.uk/about/information-...

mrc.ac.uk/about/information-standards/complaints/

[8]MRC Complaints policy

 

5. The Information Commissioner’s Office:

[9]www.ico.org.uk

ico.org.uk

[10]ICO

 

6. The MRC’s website

[11]www.mrc.ac.uk

mrc.ac.uk

[12]MRC

 

If you are still unable to access any of this information then please do
contact me again and I will provide you with copies of the information
that you have been unable to access.

 

Yours sincerely,

 

Rosa Parker

 

Corporate Information and Policy Manager

Corporate Affairs Group

Medical Research Council

 

[13]www.mrc.ac.uk

 

 

show quoted sections

Dear foi,

Information outstanding - clarified. I only seek the information from around 2015 - until now.

a) MRC's investigations into the flaws in the PACE trial and the misleading claims made by the authors/advisers and colleagues (Simon Wessley, Peter White, Trudie Chaldler, Micheal Sharpe) as detailed in peer reviewed publications, online blogs by eminent scientists outside the UK, open letters to the Lancet by eminent scientists, at the IAMECFS conference etc... These personal ignore objective outcomes and measures, fail to report on physiological measures, "massage" data in order to make it fit their own beliefs, and publish misleading papers.

See http://me-pedia.org/wiki/PACE_trial for references

b) How the MRC plans to prevent such misuse of public monies, as described above from re-occuring in the future.

c) Whether or not the MRC will continue to fund personal and organisations associated with personal, who have mislead the public and the medical profession on the nature and severity of ME/CFS e,g, Simon Wessley, Peter White, Trudie Chaldler and Micheal Sharpe with their PACE trial, Esther Crawley with her Bristol study that conflates depression and chronic fatigue with the neurological disease chronic fatigue syndrome. who ignore biomedical findings, objective physiological data, massage data in order to make it fit their own beliefs.

d) The MRC provided a link to the investinME website which details some of the concerns raised by Professor Hooper and Margaret Williams. The information I seek, however, is how is the MRC, responded to these concerns.

e) Worldwide objective, measurable, repeatable, biomedical findings and governmental bodies such as those in the USA, have clearly determined that ME/CFS is NOT a mental health disease.
I seek information on which speciality/specialities the MRC sees as able to lead productive research into ME/CFS.

Yours faithfully,

George Jenson

Dear Mr Jenson,

Thank you for your e-mail. We will respond to you as soon as we are able.

Yours sincerely,

Corporate Affairs Group
Medical Research Council
 
www.mrc.ac.uk

show quoted sections

Dear Mr Jenson,

 

MRC Reference FOI 2016-046

 

Thank you for your request for clarification and your specification that
you were seeking information from 2015 to the present date.  I will
address your questions in turn.

 

Question 1: MRC's investigations into the flaws in the PACE trial and the
misleading claims made by the authors/advisers and colleagues (Simon
Wessley, Peter White, Trudie Chaldler, Micheal Sharpe) as detailed in peer
reviewed publications, online blogs by eminent scientists outside the UK,
open letters to the Lancet by eminent scientists, at the IAMECFS
conference etc... These personal ignore  objective outcomes and measures,
fail to report on physiological measures, "massage" data in order to make
it fit their own beliefs, and publish misleading papers.

See [1]http://me-pedia.org/wiki/PACE_trial   for references

 

As outlined in our response on 13 January 2017, the MRC has not undertaken
a formal investigation of the PACE Trial. 

 

 

Question 2: How the MRC plans to prevent such misuse of public monies, as
described above from re-occuring in the future.

 

The MRC has two ways in which it seeks to prevent the misuse of public
funds. 

 

The first is through the Research Councils UK Funding Assurance Programme
which examines compliance with the terms and conditions which accompany
research funding.  Further information can be found at:
[2]http://www.rcuk.ac.uk/about/aboutRCUK/ai....

 

The second is that the MRC requires the host research organisation to have
mechanisms in place to investigate concerns relating to the studies we
fund.  Thus, any concerns relating to the PACE trial should be raised with
Queen Mary University of London (QMUL) to enable them to investigate and
respond directly.  Investigations of complaints about specific individuals
would be a matter for their employers.  If a case of Research Misconduct
were proven to be true there are a number of outcomes that may be applied
depending on the circumstances which may include sanctions against the
Research Organisations or Investigators. 

 

Further information on the MRC’s expectations regarding the governance of
good research conduct can be found at:
[3]http://www.rcuk.ac.uk/funding/researchin....

 

 

Question 3: Whether or not the MRC will continue to fund personal and
organisations associated with personal, who have mislead the public and
the medical profession on the nature and severity of ME/CFS  e,g, Simon
Wessley, Peter White, Trudie Chaldler and Micheal Sharpe  with their PACE
trial, Esther Crawley with her Bristol study that conflates depression and
chronic fatigue with the neurological disease chronic fatigue syndrome. 
who ignore biomedical findings, objective physiological data, massage data
in order to make it fit their own beliefs.

 

As outlined in our response on 13 January 2017, the MRC welcomes all
applications for funding that address any aspect of a disease or a health
condition, from all eligible researchers.

 

 

Question 4: The MRC provided a link to the investinME website which
details some of the concerns raised by Professor Hooper and Margaret
Williams.  The information I seek, however,  is how is the MRC, responded
to these concerns.

 

The example provided in our response on 13 January 2017, was one where the
MRC had responded to an individual who had raised concerns with the MRC
regarding the PACE Trial.  As stated above in response to question 2,
specific concerns relating to the conduct of the PACE Trial should be
raised with QMUL to investigate.

 

 

Question 5: Worldwide objective, measurable, repeatable,  biomedical
findings and governmental bodies such as those  in the USA,  have clearly
determined that ME/CFS is NOT a mental health disease.  

I seek information on which speciality/specialities the MRC sees as able
to lead productive research into ME/CFS.

 

As outlined in our response on 13 January 2017, the MRC has a live
cross-Board Highlight Notice, which outlines the MRC’s current priorities
(as identified by the research community) relating to research into
CFS/ME.  This notice reflects our vision -  that in order to improve the
mechanistic understanding of CFS/ME and to uncover the complex biomedical
pathways involved, we need multidisciplinary teams with diverse expertise
to come together and tackle this enormous challenge.

 

As such, and as outlined in response to Q3, we welcome applications from
all eligible researchers to address any aspect of a disease or health
condition.  With respect to the lead investigator, we expect the
applicants to follow the MRC guidance.  For further information please
refer to Section 1.3.1 of the MRC’s Guidance for Applicants which is
available at:
[4]https://www.mrc.ac.uk/documents/pdf/guid....    

 

I hope that this information has clarified the questions that you had.

 

Yours sincerely,

 

Rosa Parker

 

Corporate Information and Policy Manager

Corporate Affairs Group

Medical Research Council

 

[5]www.mrc.ac.uk

 

 

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A Baldwin left an annotation ()

Francis Rawle (head of governance at the MRC) did an investigation (or responded to letters of complaint) and said that the outcome switching was ok and also dismissed other complaints.
She is quoted as following up complaints in a BMJ article

http://www.bmj.com/bmj/section-pdf/18726...

She then gave evidence at the FoI trial to try to suppress access to the PACE data. Of course her failure to act earlier would not have motivated her willingness to give evidence.