By David Tuller, DrPH
I have sent the following letter to Jane Bridgwater, Bristol University’s director of legal services and deputy university secretary.
Director of Legal Services and Deputy University Secretary
University of Bristol
Dear Ms Bridgwater:
I have raised multiple concerns in recent years about research conducted by Professor Esther Crawley, a pediatrician at the University of Bristol, into the illness or cluster of illnesses variously known as chronic fatigue syndrome (CFS), myalgic encephalomyelitis (ME), CFS/ME, and ME/CFS, among other names. I have published my findings on Virology Blog, a science site hosted by Vincent Racaniello, Higgins Professor of Microbiology and Immunology at Columbia University.
In June, Archives of Disease in Childhood, a BMJ journal, published a €œnotice of correction and clarification” that ran to around 3,000 words and covered multiple aspects of a study called “Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial.” The review of this paper was triggered by a letter that Professor Racaniello sent to the journal on January 30, 2018. The letter itself was based on my examination of the study, which appeared on Virology Blog on December 13, 2017.
Many other experts, from Harvard, Berkeley, University College London, Queen Mary University of London, Stanford, and elsewhere–co-signed the letter, which outlined serious methodological and ethical violations of the scientific process. These violations, confirmed in the correction/clarification, included the recruitment of more than half of the sample before trial registration and the swapping of primary and secondary outcomes after the collection of data from these early participants, along with the perplexing failure to disclose these salient details in the paper.
Last week, the National Health Service€™s Health Research Authority (HRA) released the results of an investigation, jointly commissioned by the HRA and Bristol, of eleven studies I had flagged for problematic ethics statements. In all eleven cases, the Bristol team exempted the work from ethical review on the grounds that the studies qualified as €œservice evaluation€ and not €œresearch.€ In all eleven cases, this claim was based on a 2007 letter from the local research ethics committee (REC) involving an unrelated study.
In a letter I received from the HRA last week along with the investigative report, the agency noted that €œthe view of the panel [the three-person committee that conducted the investigation] concurs with our view in the HRA that all 11 of the publications contain material which would classify them as research.€ According to the report itself, “in all eleven papers, the REC reference, as cited in the ethics statement, was either inappropriate or inadequate to cover the activity described.” The report requested that, in all eleven cases, these “inappropriate or inadequate” ethics statements be corrected. For its part, the HRA has stated that, in response to this specific situation, it €œhas already made changes to the way that we produce REC minutes and written communications to applicants.”
In my opinion, the various remedies endorsed by BMJ, Bristol, and the HRA are inadequate to address the acknowledged problems with these publications. Nonetheless, the facts themselves are incontrovertible; my critiques of Professor Crawley€™s work have been substantive and well-founded. In light of that reality, I believe Bristol has an obligation to withdraw its complaints to my own academic institution–the University of California, Berkeley–about my €œactions and behaviour.€
To recap: On November 22, 2017, I wrote to Sue Paterson, Bristol€™s then-director of legal services, to ask whether Bristol had sent me a cease-and-desist letter. Professor Crawley had declared as much after I posed a question at a lecture she gave at the University of Exeter. In Ms Paterson’s response to my inquiry, she informed me that Professor Crawley€™s statement was untrue–no cease-and-desist letter had been sent. Ms Paterson added, however, that €œprivate and confidential communication€ at “a senior level” had taken place between Bristol and Berkeley. This communication, according to Ms Paterson, involved my €œactions and behaviour€ toward Bristol personnel.
Since my €œactions and behaviour€ consisted of engaging in robust but accurate criticism of Professor Crawley€™s research, defending myself vigorously against Professor Crawley’s unsupported allegations of libel, and attending a public lecture, I could not imagine what complaints Bristol could have. No one from Bristol€™s legal services team had expressed concerns to me about my €œactions and behaviour.€ I subsequently learned from my academic department that the Bristol vice-chancellor€™s office had sent multiple missives to the Berkeley chancellor. While I have not seen these communications, my understanding is that Bristol did not contest or rebut the facts I had meticulously documented. Nor apparently, did these communications include evidence of wrongdoing.
Given the extensive correction/clarification in one major study and the identified need for corrections in the ethics statements in eleven others, I believe that Bristol, if anything, owes me a debt of gratitude for seeking to ensure the methodological and ethical integrity of papers published by university faculty. From my perspective, it was inappropriate for Bristol€™s administration to register complaints with Berkeley about my efforts to shed light on irregularities in the medical literature. It is past time for these unwarranted appeals to my employer to be formally rescinded.
I am cc-ing Professor Racaniello, since complaints involving my posts on Virology Blog implicate him as well. I am also cc-ing Professor Arthur Reingold, Division Head of Epidemiology and Biostatistics at the University of California, Berkeley, and Co-Director of my academic home, the Center for Global Public Health at the School of Public Health. Finally, I am cc-ing Jami West, executive personal assistant to Bristol University€™s vice-chancellor.
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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