Yesterday, journalist and public health expert Dr. David Tuller published on Virology Blog a list of 68 questions for the authors of the controversial PACE trial. The trial studied the effects of graded exercise and cognitive therapy on chronic fatigue syndrome.
Dr. Tuller has, he said, been seeking answers from the PACE researchers for more than a year but they have declined to discuss the trial with him.
In October, Dr. Tuller published a detailed exposé of serious problems with the trial that sparked an explosion of critical interest in PACE among scientists outside the ME/CFS community. With others, he has submitted a request for data from the trial but says, “the numbers will not provide answers to the questions I find most compelling. Only the researchers themselves can explain why they made so many ill-advised choices during the trial.”
The list, divided into 26 sections, consists of those questions that Dr. Tuller had compiled towards the end of his investigation of the trial and most, he says, remain unanswered. He says that he had noticed the “non-responsive responses” given by the PACE authors to patients’ “cogent and incontrovertible points” in journal correspondence. The researchers, he said, “appeared to excel at avoiding hard questions, ignoring inconvenient facts, and misstating key details” and so his list of questions was designed to “push past the PACE team’s standard portfolio of evasions”.
The list opens by asking whether the authors share the concerns raised by a US National Institutes of Health report that the Oxford definition of chronic fatigue syndrome used in the PACE trial is so non-specific that it impedes research progress and could cause harm to patients. It goes on to ask whether the researchers have a response to criticism that PACE’s use of subjective outcomes in an unblinded trial renders its results valueless.
Further questions include whether the authors agree that they violated the ethical research guidelines of the Declaration of Helsinki in failing to disclose their conflicts of interest to potential study participants; and why the authors have issued no correction to their paper in The Lancet concerning their acknowleged mistake concerning their calculation of a key threshold for recovery of physical function in the trial.
Dr. Tuller says that although he suspected that he would never get the chance to pose the questions to the researchers himself, he hoped that the list “would be a useful guide for anyone who wanted to conduct a rigorous interview”.
Despite his publication of a 14,000-word investigation of the PACE trial, Dr. Tuller says, “I still don’t have the answers to my questions.”