Trial By Error: A Follow-Up Letter to Bristol

By David Tuller, DrPH

Two weeks ago, I sent a letter to the University of Bristol in which I requested that it withdraw its complaints to Berkeley about my “actions and behaviour.” Not long afterwards, I was informed by my academic department that the Berkeley chancellor had received a note from Teresa Allen, the chief executive of the Health Research Authority”“the regulatory body that oversees research ethics for the National Health Service.

In that note, she expressed thanks for my role in shedding light on these issues”“and did not mention my “actions and behaviour.” I thought I should make sure that Bristol knew about the HRA’s message to Berkeley. So earlier today, I sent Bristol the following follow-up letter.

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Dear Ms Bridgwater,

I have not heard back from Bristol regarding my request of October 29th that the university withdraw its complaints to my own academic institution about my “actions and behaviour.” Under the circumstances, I wanted to share with you and the vice-chancellor’s office the gracious letter that Teresa Allen, chief executive of the Health Research Authority, sent on October 30th to Carol Christ, chancellor of the University of California, Berkeley. (As you know, the HRA oversees research ethics as part of the National Health Service.)

Below is the text of the HRA letter:

Dear Chancellor Christ,

You may be aware that we recently responded to concerns that David Tuller shared with us about several research studies involving patients with CFS/ME. This response, made in line with our processes for complaints and concerns, has taken a significant amount of time as we have had to work across a number of organisations and we are grateful to David for his patience.  As the concerns raised with us were wide-reaching, unfortunately we were unable to answer questions which fell outside the remit of the Health Research Authority (HRA). You can read a full statement on our website https://www.hra.nhs.uk/about-us/news-updates/outcome-expert-panel-review-eleven-publications-chronic-fatigue-syndrome-cfs-and-myalgic-encephalomyelitis-me/

We have identified and implemented a number of improvements to procedures as a direct consequence of David’s concerns together with similar questions raised by other individuals. We constantly review, with our Research Ethics Committees, the ways in which we work to ensure that they remain fit for purpose, and we are grateful when potential issues are brought to our attention.

We fully understand and support the need for more comprehensive research into this dreadful condition which affects so many people’s lives.

With Regards

Teresa Allen

The HRA appears to appreciate my efforts, and the efforts of others, to shed light on irregularities in the literature on the illness variously known as chronic fatigue syndrome (CFS), myalgic encephalomyelitis (ME), CFS/ME, and ME/CFS. For my part, I appreciate that Teresa Allen took the time to alert Chancellor Christ to the outcome of this investigation into the work of Professor Esther Crawley, a pediatrician and specialist in this domain. 

In a statement two years ago, Bristol declared that “the University has previously reviewed Professor Crawley’s research projects and found they are being conducted in line with applicable research ethics and governance requirements.” Last June, however, Archives of Disease in Childhood appended a 3,000-word correction to Professor Crawley’s Lightning Process trial. Professor Crawley has since been ordered to correct the ethics statements in 11 other papers. 

It is therefore evident that Bristol’s prior review of Professor Crawley’s research reached erroneous conclusions. Perhaps this failure in oversight will lead Bristol to examine how its internal vetting processes could have missed substantive methodological and ethical issues that were obvious to others. Given the documented facts, it is troubling that Bristol, in contrast to the HRA, has sought to cast blame on those who have highlighted such matters.

I am cc-ing the vice-chancellor’s office on this letter. I am also cc-ing Vincent Racaniello, Higgins Professor of Microbiology and Immunology at Columbia University and the host of Virology Blog, the science site on which I post my findings about research from Bristol and elsewhere. And since the National Institute for Health and Care Excellence is currently creating new guidelines for ME/CFS, I am cc-ing several individuals involved with the process to keep them abreast of relevant research developments. Specifically, I am cc-ing three physicians (Dr Luis Nacul, Dr William Weir, Professor Jonathan Edwards) as well as two patients serving as lay members of the NICE guideline committee (Adam Lowe and Sally Burch).

Best–David

David Tuller, DrPH
Senior Fellow in Public Health and Journalism
Center for Global Public Health
School of Public Health
University of California, Berkeley

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