The international community of people with myalgic encephalomyelitis - also called chronic fatigue syndrome or ME/CFS - are celebrating a long awaited victory this week.
The Queen Mary University of London (QMUL) has been ordered to release previously withheld data from a treatment trial under the UK Freedom of Information Act. Patients and advocates hope the ruling will lead to more rigorous critique of the trial’s controversial treatment recommendations.
To understand the significance of this ruling, a quick ME/CFS primer may be needed. A complex disease impacting the immune, digestive, cardiac, endocrine and autonomic nervous systems ME/CFS can be debilitating. I speak from 11 years of experience. Imagine having the flu with a hangover the day after competing in a triathlon and you’ll have some idea of the impact. Many with ME/CFS are too ill to care for themselves. Some must be tube fed and no longer leave their beds.
One would imagine that a treatment trial would be good news to such a patient body, but in 2011, when the PACE trial was published in The Lancet, the ME/CFS community responded with a collective sigh of dismay.
The PACE trial is, to date, the largest study on ME/CFS treatments ever conducted, and recommends cognitive behavioural therapy (CBT) and graded exercise therapy (GET) as the most effective treatments, claiming a modest 22 percent recovery rate. These treatments were developed in the nineties on the assumption that ME/CFS symptoms were maintained by erroneous illness beliefs which could be interrupted with intervention (basically encouraging chronically ill people to think positive and do more). The treatments are controversial because they essentially place responsibility on the patient for both the state of their health and any potential recovery, and seem to ignore the wealth of scientific evidence demonstrating that ME/CFS is actually a physiological disorder. GET is also considered to be quite dangerous in patient circles. When surveyed, 74 per cent of respondents who had tried GET indicated it had worsened their condition.
"Pushing at the limits can result in extended “crashes” that can last days or years."
A defining symptom of ME/CFS is a physical overreaction to exertion, usually involving pain, weakness and cognitive dysfunction. Small activities require disproportionate recovery time. Pushing at the limits can result in extended “crashes” that can last days or years.
Imagine you went to your doctor with two broken legs and were told the only proven treatment was to see a psychologist and start jogging. Broken legs should not hold you back. It might hurt, but putting weight on broken bones can’t actually do you harm. You just need to get motivated.
That sense of incredulity is how a lot of people with ME/CFS feel when their medical professionals start suggesting CBT and GET, so when a large study (and accompanying media campaign) began recommending them widely, patients with scientific backgrounds, including Australian Alem Mathees, began to scrutinise PACE to deduce how such unexpected results had come about.
Their findings were troubling. The trial was riddled with flaws, detailed here by US public health expert David Tuller, but the most shocking find was that the trial’s definition of “recovery” had been broadened. Now 13% of participants were considered “recovered” on one or two outcomes before receiving any treatment. Working-age participants were considered “recovered” with the functionality of the average 75 year-old, or someone with class II congestive heart failure. Most incredibly, it was actually possible to worsen over the course of the trial, and still be considered “recovered” by the end.
How they would have fared with their own original definition of recovery is still a mystery, as the raw data has been kept tightly under wraps. Hence Alem Mathees filed his Freedom of Information (FOI) request for that very data.
"Imagine you went to your doctor with two broken legs and were told the only proven treatment was to see a psychologist and start jogging."
QMUL has now spent over £200,000 ($340,000 AUD) on legal fees to protect that data from independent scrutiny, making one wonder just how damning a reanalysis might actually be. They have also attempted to have FOI requests dismissed as a form of harassment against the PACE investigators, framing Mathees and his colleagues as "borderline sociopathic or psychopathic" in their attempts to hold QMUL to account. This sentiment was dismissed by the Information Commissioner as "wild speculation” and “gross exaggeration” when sufficient supporting evidence of harassment was not forthcoming.
But ultimately, the fight for good science, transparency and open data sharing has prevailed, as the final QMUL appeal has now been dismissed and the PACE investigators ordered to release the anonymised data for public scrutiny.
“Both the Tribunal’s decision and commentary are a long overdue victory for the patient community,” says Mathees, now a successful claimant of the trial. “This case ended up costing me greatly in time, energy, and health (currently bedridden) … but false or misleading claims of recovery or remission from debilitating illness simply have no place in the scientific literature.”