By Sasha Nimmo

Prof Rodney Phillips, Dean of  Medicine at the University of New South Wales (UNSW) denies that Prof Lloyd’s trial would cause harm to participants and refuses to stop the trial or amend it in any way. The university says the people who are protesting harbour ‘resentment against the notion that CFS may have psychological causes’, while there is no evidence for their argument.

The letter from Prof Phillips was in response to the petition protesting a trial of a training module of graded exercise therapy (CBT) and cognitive behaviour therapy (GET) for health professionals. The petition was sent to UNSW’s Vice Chancellor Prof Ian Jacobs; the Mason Foundation; the federal health minister and the National Health and Medical Research Council (NHMRC). It asked them to stop UNSW’s trial of an education module for health professionals which treats chronic fatigue syndrome patients with GET/CBT, despite the evidence showing these therapies have no benefit and often cause permanent harm.

The trial registration says “despite GET and CBT being widely acknowledged as best-practice interventions for CFS, the great majority of patients in Australia are not receiving these appropriate evidence-based interventions. Recent studies have demonstrated that the reason for this documented gap between research and practice is largely due to practicing health professionals lacking the knowledge and skills to provide appropriate care.”

The letter from UNSW explains that the dean believes chronic fatigue syndrome (CFS) to be a subjective diagnosis of exclusion; going against researchers at ANU, Melbourne University, Griffith University and overseas at Stanford University and other leading universities, who use the Canadian or International Consenus criteria and have made significant medical progress. The World Health Organisation also classify it as neurological, not psychological.

“This is a difficult, and often controversial, clinical syndrome featuring disabling subjective fatigue,” said Prof Phillips

“The diagnosis is made after careful exclusion of alternative medical and psychiatric explanations for the fatigue state. The controversy typically relates to the validity of the illness as a separable diagnostic entity, and also whether the illness has a purely ‘psychological’ basis. I do not propose getting into those arguments here.”

It appears that UNSW do not have a clear grasp of the illness in the group of people they are aiming to treat.

“Since listing the trial on the register, the study investigators and the UNSW HREC have been receiving correspondence from critics requesting the trial not go ahead. This response essentially reflects resentment against the notion that CFS may have psychological causes.”

It poses an international risk, as UNSW plan to “disseminate the treatment to other centers nationally and internationally”, according to information the University provided to the National Health and Medical Research Council.

“The scientific evidence base for CBT and GET patients with CFS both individually and combined is very strong,” argued Prof Phillips.

However Geraghty 2016 found “re-analysis showed that the levels of improvement and recovery observed in the released data were much lower than the levels reported in the published report (White et al., 2011a) and other related publications. The released data showed that the effectiveness of cognitive behavioural therapy (CBT) and graded exercise therapy (GET), in comparison to standard medical care (SMC) and adaptive pacing therapy (APT), fell by almost two-thirds.

The New York TimesGetting It Wrong on Chronic Fatigue Syndrome‘ pointed out “when the study’s findings were first published, patients and some scientists noted a stunning problem: The investigators had weakened their outcome measures from their trial protocol so much that participants could actually deteriorate on physical function and still qualify as “recovered.” Thirteen percent entered the trial already having met the definition of “recovered” on that measure.”

Even the head of the USA’s National Institute of Health recognises that reconditioning is not the answer, writing about in the Director’s Blog this month.

“Any exertion just makes you worse,” said Dr. Walter Koroshetz and Dr. Francis Collins.

“A number of studies suggest that abnormalities in cellular metabolism, a complex biological process that the body uses to create energy [3][4][5], may underlie ME/CFS. A recent study of metabolite pathways in blood samples from people with ME/CFS reported a signature suggestive of a hypometabolic condition, similar to a phenomenon biologists have studied in other organisms and refer to by the term “dauer” (a hibernation-like state) [5]. A number of other studies have suggested that changes in the immune system may play a causal role in ME/CFS [6][7][8], either due to a post-infectious autoimmune process or due to a unknown chronic infection.”

It is incomprehensible that UNSW continue to defend the PACE trial, going against more than 120 of the world’s leading researchers and clinicians in the field as well as patient organisations from around the world, who signed an open letter asking for the study to be retracted.

The letter said the PACE trial had null results for recovery, according to the protocol definition selected by the authors themselves. Besides the inflated recovery results reported in Psychological Medicine, the study suffered from a host of other problems, which are too numerous to list in this article.

“The PACE investigators have published analyses refuting all of these concerns,” was the response from the UNSW dean.

Wilshire, Kindlon and McGrath 2017 were clear in the rejoinder after reading the PACE investiagators re-analysis: “the PACE trial provides no evidence that CBT and GET can lead to recovery from CFS. The recovery claims made in the PACE trial are therefore misleading for patients and clinicians.”

Screen Shot 2017-03-30 at 3.23.02 pm

Figure 1 from Matthees, Kindlon, Maryhew, Stark & Levin 2016.

Sense about Science wrote about the problems. “The fundamental [issue], which is that the way PACE was designed and redesigned means it cannot provide reliable answers to the questions it asked. There is really not a lot that can be said to mitigate that; it’s a terminal prognosis.”

“The conclusion of Rebecca Goldin’s 7,000-word analysis on PACE’s design is this: “The best we can glean from PACE,” concludes Goldin, “is that study design is essential to good science, the flaws in this design were enough to doom its results from the start.””

UNSW not only accept this flawed science, but are promoting it.

“There is clear level one evidence for both cognitive behavioural therapy (CBT) and graded exercise therapy (GET), both from the Cochran collaboration and from a recent NIH expert workshop,” said Prof Phillips.

“It is important to emphasise that this trial is not an evaluation of the effectiveness of the CBT/GET intervention but a trial of education for healthcare practitioners on how to conduct CBT/GET intervention for patients with CFS.”

Prof Phillips insisted that there was no risk of harm, despite the petition pointing out that the ME Association found that 74% of people were worse after graded exercise therapy.

He said that the training would safeguard them against any notional risk of harm.

“The concern of harm from GET is not supported by the systematic reviews which state no evidence suggests that exercise therapy may worsen outcomes,” said Prof Phillips.

How can UNSW base their research on the results of a trial with “flaws are so egregious that it would serve well in an undergraduate textbook as an object lesson in how not to design a trial,” Edwards 2017?

“His [Lloyd’s] approach combining pathophysiological research and treatment research underpins his NHMRC practitioner fellowship as it seeks to improve the care of patients with CFS.”

Here in Australia, reported that “incorrectly claiming that a significant number of CFS patients can actually recover from a treatment can cause real harm”.

“Based on the evidence I have outlined above I’m not prepared to require that the study be suspended or abandoned. It is in fact nearly complete in any case,” said Prof Phillips.

“I do not accept that there is any reason to accede to your request.”

Read the full letter: Letter DM0797 – Sasha Nimmo – 22 March 2017-3 .