Letter to Prof. Hugh Brady, VC Bristol University, Nov 2016

I did not put this on public record when I sent it a year ago. I have had no reply or even an acknowledgement. I sent it by snail mail marked Private and Confidential.
Now that we have a forum for keeping a record of open letters, I've decided to share it here.

29th November 2016

Professor Hugh Brady
Vice Chancellor and Principal
University of Bristol.

Dear Professor Brady,

I am writing to you as a concerned citizen about a medical trial being undertaken at the University of Bristol which is already attracting international attention for its poor quality and for the wide advance publicity making unsubstantiated claims of success rates before the trial has started. There is a serious reputational risk to the University of Bristol, as has happened to Queen Mary University London (QMUL) following the debacle of the forced release of the PACE trial data (see below).

The Bristol trial in question is called FITNET, a trial of internet based therapy for Chronic Fatigue Syndrome (CFS/ME). You may be aware of controversy surrounding this condition and its treatment. Professor Esther Crawley, the principal investigator, favours treatments based on cognitive behaviour therapy and graded exercises / activity management. She claims there is a sound evidence base for these methods and that they are not harmful (both claims incorrect). She defines CFS/ME in children by the single symptom of three months unexplained fatigue. Neither this overly inclusive definition, nor these treatments are accepted as having any validity by international researchers, apart from a small coterie of British and Dutch doctors, most of them psychiatrists.

Rather than spell out the problems with FITNET myself, I urge you to read the two attached articles published by Dr. David Tuller, DrPH. David Tuller is academic coordinator of the concurrent masters degree program in public health and journalism at the University of California, Berkeley.

At the recent IACFSME conference in the USA papers were presented by biomedical researchers from all over the world demonstrating that CFS/ME is a serious biological condition not amenable to psychological or exercise treatment. There are neurological, immunological, genetic, epigenetic and metabolic findings suggesting a hypometabolic state with problems of energy production which make exercise problematic. Internationally recognised research definitions list post exertional malaise (PEM), not fatigue, as the cardinal symptom defining CFS/ME. I attach a Medscape article highlighting some research reported at the conference. I also give a link to a webinar by Professor Anthony Komaroff of Harvard University reporting on the conference.

The QMUL case mentioned above refers to the PACE trial of CBT and graded exercise therapy (GET) in adults. There has been international condemnation of the flawed methodology and distorted reporting of the findings of this trial, which, if properly analysed according to protocol, was a null trial. I attach a letter from many eminent scientists and doctors asking the Lancet to retract the paper. QMUL spent over £200,000 trying, unsuccessfully, to prevent the disclosure of anonymised raw data from the PACE trial, which has now been re-analysed, showing that the treatments did not lead to improved recovery rates as the authors had claimed (see attached report). It may or may not be coincidence, but the Principal of QMUL and the Principal Investigator of PACE announced their retirement shortly after the data was released.

I attach a list of further references to help you understand the saga of CFS/ME research in the UK. This has a long and sorry history, involving psychiatrists at the heart of the British medical establishment, going right to the top, with influence in the Medical Research Council, Science Media Centre, NICE guidelines, Cochrane reviews and government. The story of this scandal is being written as it happens, and will eventually become fully public. I do hope you will not let Bristol University be drawn any further into the scandal and will find a way to stop the FITNET trial before it does further damage to the University’s reputation and to the health of vulnerable children. There are serious questions about all of Prof. Crawley’s research into CFS/ME, which I would urge you to investigate including trials called SMILE and MAGENTA, not yet published.

If you would like to discuss this situation with doctors who are fully informed about it, I suggest you contact the medical advisors to the ME Association, Dr Charles Shepherd and Dr Nigel Speight, and the medical advisor to Invest in ME Research, Professor Jonathan Edwards (Emeritus Professor, UCL).

I would be grateful if you would keep my name and address confidential, as whistleblowers can be vulnerable, and my identity has no relevance to your enquiries.

I may decide in future to publish this letter and (with permission) your reply.
Yours sincerely,

Ms Patricia Davis
(address and e-mail address redacted)

 

This is the list of references I attached.

IACFSME conference reports:

Medscape articles

http://www.medscape.com/viewarticle/871552

http://www.medscape.com/viewarticle/871482

Professor Anthony Komaroff (Harvard) summary of conference webinar:




Countess of Mar’s formal complaint to the BBC about Professor Crawley’s recent media blitz

http://www.margaretwilliams.me/2016/bbc-complaint-mar-nov16.pdf


TYMES trust (The young ME sufferers trust):


I page statement from Dr Nigel Speight ‘Does graded exercise therapy cure ME’

http://www.tymestrust.org/pdfs/vision2011-1insert.pdf


Published paper on harms of forced GET and child protection issues.

http://www.tymestrust.org/pdfs/falseallegations.pdf


Banned from sleeping - 1 page detail about why sleep restriction is counterproductive

http://www.tymestrust.org/pdfs/ttbannedfromsleeping.pdf


List of Tymes publications

http://www.tymestrust.org/tymespublications.htm


Virology blog - including articles by David Tuller:


An open letter to Dr Horton, editor, the Lancet

http://www.virology.ws/2015/11/13/an-open-letter-to-dr-richard-horton-and-the-lancet/

Second letter with full list of signatories

http://www.virology.ws/2016/02/10/open-letter-lancet-again/


Non-recovery data reanalysis of PACE trial data following release

http://www.virology.ws/2016/09/21/no-recovery-in-pace-trial-new-analysis-finds/


Open letter to Principal of QMUL requesting data release

http://www.virology.ws/2016/09/06/open-letter-to-queen-mary-university-london-about-pace/

About harassment

http://www.virology.ws/2016/02/01/trial-by-error-continued-a-few-words-about-harassment/


About FITNET

http://www.virology.ws/2016/11/21/trial-by-error-continued-the-new-fitnet-trial-for-kids/


http://www.virology.ws/2016/11/28/trial-by-error-continued-a-follow-up-post-on-fitness-nhs/


Dr Keith Geraghty - paper in the Journal of Health Psychology on PACE-gate:

http://hpq.sagepub.com/content/early/2016/10/27/1359105316675213.full.pdf.html

Dr. Geraghty’s article in Nursing in Practice June 2016 not all in the mind. Gives good overview of history.

http://www.nursinginpractice.com/ar...gic-encephalomyelitischronic-fatigue-syndrome


Faculty Lounge - a US legal ethicist on PACE-gate and conflict of interest in those promoting a therapy researching it and influencing outcomes - also relevant to FITNET.

http://www.thefacultylounge.org/2016/11/the-pace-study-open-access-and-conflicts-of-interest.html

Open letter to Professor Sir Simon Wessely (key proponent of the now discredited biopsychosocial model of ME and instigator and supporter of PACE.) and his response.

http://www.thefacultylounge.org/201...simon-wessely-defender-of-the-pace-study.html


Information commissioner tribunal ruling

http://informationrights.decisions....iversity of London EA-2015-0269 (12-8-16).PDF

(See p24 for Professor J. Edwards comment on poor quality of trial, and p36-7 for comment on harassment.)


MEAction Network statement about FITNET with useful links. http://www.meaction.net/2016/11/02/...bt-in-treatment-for-chronic-fatigue-syndrome/


Parliamentary questions about ME research and NICE guidelines http://bit.ly/2gyJ0il

 

Reminds me that I had more energy a year ago than I have now. Sigh!

Should I send it again, by e-mail and ask why he didn't reply?

 

Thanks @Esther12 . That part of the letter was particularly addressed to Prof Brady, because, when I looked up his biography, I saw that he is from Dublin, trained in Medicine there, then spent a large part of his career in the USA in academic medical research posts before returning to Ireland as a Professor. He is relatively new to Bristol Uni, and is not part of the 'British Medical/Political Establishment'. I hoped he might therefore have a more open mind on this.