Why the PACE trial is bogus

And why Australia is so reliant on it

One of the first things that you learn when you are diagnosed with Chronic Fatigue Syndrome (CFS) in Australia is that there are only two forms of treatment that have been scientifically proven to be successful: Cognitive Behaviour Therapy (CBT) and Graded Exercise Therapy (GET). Unfortunately for CFS fighters, this is not true. Both of these treatments are predicated on false notions of what the disease truly entails.

The ubiquitous use of CBT and GET in Australia can be attributed to the influence of the UK’s PACE trial. The PACE trial is the largest study for CFS treatment, costing around $8 million in total. The very basis of the PACE study revolves around the false assumption that CFS is a physical debility caused by deconditioning. The PACE study ignores robust evidence that reveals CFS is a physical disease characterised by immunological and neurological dysfunctions. Not only this, but the suggestion of CBT as a viable treatment reinforces the ridiculous (and consistently refuted) idea that symptoms of CFS are psychological in origin.

Dr. David Tuller, an academic at the University of Berkeley, has made it very clear that the UK’s PACE trial is a bunch of bogus. His critique of the study is dot-pointed in an article he wrote for the Virology blog in 2015 entitled Trial by Error: The Troubling Case of the PACE Chronic Fatigue Syndrome Study.

Dr. Tuller criticises the PACE trial for focusing on rehabilitative non-pharmacological research. He further admonishes the PACE trial’s attempt to improve the physical abilities of patients (which could potentially make them worse) and the psychological approach it takes to alter patients’ perceptions of their condition.

[Patients] bristled with offence at the suggestion they would get better if only they could change their perceptions about their condition. And pushing themselves to be more active not only wasn’t helpful, they insisted, but could trigger a serious and extended relapse.

Currently, the PACE trial allows a patients’ physical function to worsen during the trial to something reminiscent of the average level of Class II congestive heart failure and still the patient is considered as having received effective treatment.

Experts have examined the study and found it to be fraught with problems.

Ronald Davis, a well-known geneticist at Stanford University and the director of the scientific advisory board of the Open Medicine Foundation, claimed,

“The PACE study has so many flaws … I don’t understand how it got through any kind of peer review’

Jonathan Edwards, a professor researching pharmacological trials for CFS treatment, also pointed out the mistakes made in the PACE trial:

“Not only did the trial rely on subjective measures, but participants and therapists all knew which treatment was being administered, unlike in a double-blinded trial. This unblinded design made PACE particularly vulnerable to generating biased results.”

Dr. Leonard Jason, from DePaul University, said:

“The PACE authors should have reduced the kind of blatant methodological lapses that can impugn the credibility of the research, such as having overlapping recovery and entry/disability criteria.”

The list of complaints and criticisms are endless.

Emerge Australia, an advocacy group for CFS patients, recently wrote to the Queen Mary University of London (QMUL) asking for raw data from the PACE trial. They were refused. QMUL believes the study is exempt from freedom of information laws. You can read their response here.

Emerge Australia is deeply concerned by this response and the fact that “Australian medical practitioners are using the findings from the PACE trial which recommends using Graded Exercise Therapy (GET) to treat people with ME/CFS.”

The president of Emerge Australia, Sally Missing, believes funding for homegrown CFS research is the next step. After all, if Australia allocated some funding for CFS research, it wouldn’t have to rely upon defunct studies from the UK.

“We believe that funding should go towards biomedical research which is uncovering important new findings. There is no good evidence to support the use of graded exercise therapy or cognitive behaviour therapy and there is important emerging evidence on genetic and immune markers for the condition, so we ask the Department of Health not to waste precious research dollars on those studies.”

The problem is, Australia has spent a measly $1.6 million on CFS research since 2000, according to the Australian Department of Health. This number comes after the figure was revised downward by the Department when Senator Scott Ludlum found:

‘About two-thirds of the funding [appeared] to be going into research that, however worthy, actually has nothing at all to do with ME/CFS.’

That’s right. The money that Australia was supposedly putting into CFS was actually going to Hepatitis C and other diseases which are not CFS.

This is despite the fact that there are an estimated 242 000 CFS fighters in Australia.

If you do the calculations — that means that currently each patient is allocated around 40 cents per year in CFS research.

40 cents.

The small amount of research that is actually being done on CFS in Australia is mostly targeted at graded exercise therapy and cognitive behavior therapy programs.

In fact, the University of NSW is proposing a training program for medical practitioners teaching them how to use CBT/GET on CFS patients. They even conducted a micro study of their own testing GET on patients with mild CFS despite the harm it may cause patients. The study conducted had:

• No comparison group.
• No severely ill patients.

The paper claimed:

“…cognitive-behavioral therapy (CBT) and graded exercise therapy (GET) have consistently produced moderate improvements in levels of reported fatigue as well as cognitive and social functioning in controlled trials.”

There was no reference provided for the quote.

Great.

When Emerge Australia asked the Health Department why there is no federal funding for support of people with the condition, advice about medical treatments, training of medical and allied health staff and dissemination of information, the Department took the question on notice (in other words “oh s**t - let’s just leave it and hope they forget about us…”).

To the Department of Health: We will not forget the answers you owe us.

In the meantime, GET and CBT treatments will continue to be administered to Australian CFS fighters, while they wait for the Health Department’s response and the millions of dollars of research funding that they are due.