In wake of David Tuller’s investigation, PACE investigators publish follow up study
Last week, journalist David Tuller published a four-part investigative piece on the 2011 PACE trial, a £5 million (US$8 million) non-blind study of cognitive behavioral therapy (CBT) and graded exercise (GET) as treatment for chronic fatigue syndrome.
In his piece, Tuller quotes top researchers in the US and UK who have found the study to be “fraught with indefensible methodological problems.” Emeritus Professor Jonathan Edwards found it “a mass of un-interpretability.” Bruce Levin, a Columbia University epidemiologist called the study “the height of clinical trial amateurism.” Arthur Reingold, an epidemiologist at the University of California stated that an independent review of the study was “very much in order.” Stanford geneticist Ron Davis questioned how it even got through peer review, given its deep methodological flaws.
Today by coincidence, Michael Sharpe and Peter White, the investigators who designed the original PACE trial, published a follow up to their 2011 study on Tuesday in The Lancet Psychiatry in which they claim that two years later, three quarters of the original trial participants who had been assigned to receive CBT and GET were found in a self-reported survey to have maintained their improvements in fatigue and physical function, suggesting that the purported benefits of those treatments were maintained in the long run.
Science reports on the PACE controversy
However as Jon Cohen reports in an article appearing online yesterday in Science, those who were randomized to the other treatment groups (“specialist care” and “adaptive pacing” therapy) also reported similar improvements to those receiving CBT and GET. Sharpe and White write that this may be because those patients who did not receive graded exercise and cognitive behavior therapy in the study later sought them out. (An alternative hypothesis is that all patients in the study reported similar levels of improvement after treatment because none of the interventions in the original study had any meaningful effects.)
The conclusions Sharpe and White draw in this new study are especially troubling given that in the original trial, participants who were assigned to graded exercise walked fewer meters in six minutes than patients with pacemakers, patients with class II heart failure, and cystic fibrosis patients – a level of function they defined as “recovery.”
The Daily Telegraph touts “exercise and positivity”
The Telegraph published a piece today based solely on the contributions of Prof. Michael Sharpe and Peter White’s press conference. The headline of the piece reads “Exercise and positivity ‘can overcome ME.’” This is the article’s lede:[pullquote align=”full” cite=”” link=”” color=”” class=”” size=””]Chronic Fatigue Syndrome is not actually a chronic illness and sufferers can overcome symptoms by increasing exercise and thinking positively, Oxford University has found.[/pullquote]
In it Sharpe describes ME as a “self-fulfilling prophesy” that happens when patients live within their limits. This is in contrast to many patients who find that living within their limits help them to sustain whatever is their baseline level of function.
The Daily Mail reported on the new Lancet Psychiatry study with the headline “All in the mind? ME can be cured by counselling, says Oxford professor who claims some sufferers do not push themselves to recover.”
When asked at the press conference yesterday, Sharpe further said that he didn’t think there was “a growing army of people upset about this” and that he did not understand “what motivates the very vocal minority that gets so upset about this apparently benign bit of moderately helpful treatment.”
In light of Tuller’s investigative piece, #MEAction has launched petition to demand that the journals that have published studies based on the PACE trial data retract their claims about recovery.