By David Tuller, DrPH
On Friday, I sent the following request to the University of Bristol. I cc-d Sue Paterson, the director of legal services. I received an automatic reply alerting me that Bristol was behind in responding to FOI requests, meaning that a response is unlikely within the mandated period of twenty working days.
One point of this request is to try to find out if Bristol took any action when it learned of the concerns about the conduct and reporting of the Lightning Process study. The seriousness of the documented ethical and methodological violations should have alarmed anyone at Bristol who found out about them.
Dear Freedom of Information Office–
I am requesting information related to the trial of the Lightning Process as a treatment for pediatric CFS/ME, which was conducted by investigators from the University of Bristol (UoB) and published in Archives of Disease in Childhood (ADC) in 2017.
In January 2018, ADC received a letter signed by multiple experts expressing concerns about the conduct and reporting of the trial. In response, ADC promised to review the matter. In June 2018, ADC posted an editorâ€™s note about the trial that referred to â€œclarificationsâ€ the investigators provided in response to the concerns raised.
1. Did the investigators notify UoB that ADC had raised concerns about the conduct and reporting of their trial? If so, on what date did the investigators notify the university?
2. Have the investigators provided UoB with the formal responses they gave ADCâ€”â€œclarifications,â€ per the editorâ€™s note–to the concerns raised about the conduct and reporting of their trial? If so, can you provide a copy of the formal responses or â€œclarificationsâ€ that were given to ADC?
3. Given the nature of the concerns raised by ADC, did UoB set up a review or investigation into the conduct and reporting of the trial? If so, can you provide a copy of the results of this review or investigation?
I would be happy to receive this information in electronic format.
David Tuller, DrPH
Senior Fellow in Public Health and Journalism
Center for Global Public Health
School of Public Health
University of California, Berkeley