From Mail Online, by Jerome Burne, 15 August 2017. This article also made it into the print edition.
How the best treatment for the debilitating condition is one of the most bitterly contested areas in medicine
- Myalgic encephalomyelitis can leave those affected bedridden for years
- It’s linked with 60 symptoms, most commonly a feeling of constant exhaustion
- There’s been a long-running debate between doctors and patients about cause
Myalgic encephalomyelitis (ME) is a debilitating condition that can leave those affected bedridden for years. It’s linked with as many as 60 symptoms, the most common being a feeling of constant exhaustion — ‘like a dead battery’.
The condition first reached mainstream consciousness in the Eighties following outbreaks in New York and Nevada. By then it was officially known as chronic fatigue syndrome (CFS).
For a time, it seemed everyone knew someone who was affected by it, and it was derisively dubbed ‘yuppie flu’ because it seemed typically to affect young professionals.
For years there’s been a long-running and bitter debate between doctors and patients about its cause and how to treat it.
The lack of a clear physical cause meant many doctors dismissed it as all in the mind. This infuriated patient groups who insisted it was all too real and the result of an infection or immune system failure.
Even now, when it is generally accepted that ME/CFS is a genuine condition, it remains one of the most angrily contested areas of medicine. But the battle lines are no longer drawn just between patients and doctors: the medical community itself is at loggerheads.
THE ISSUE: THE BEST WAY TO TREAT ME
This has huge significance for the estimated 500,000 people in Britain affected by it. The official NHS treatment for their condition is delivered by psychologists and involves a combination of cognitive behavioural therapy (CBT) and graded exercise therapy (GET) which involves doing a little more each day.
The idea is that doing regular aerobic exercise would help patients a lot, but that they are held back by ‘fear’ of activity: the CBT is meant to overcome this.
Many patients and doctors claimed this combination provided little if any benefit.
This dispute has now broken out into the public arena in an extraordinary fashion. Two weeks ago the Journal of Health Psychology published what was effectively an attack on the official NHS treatment.
INSULTS TRADED BY BOTH SIDES
Three editors resigned from the journal in protest at this stance. In a leaked email, one of the resigners was described as a ‘disgusting old fat neo-liberal hypocrite’ and an ‘ol’ sleazebag’ by an editor who supported the journal’s approach.
But the insults swing the other way, too — recently, a scientist described patients critical of the CBT approach as ‘borderline psychopaths’ and likened them to animal rights activists.
The row is about a trial published in The Lancet in 2011 that helped form the official guidelines on treating the condition.
This was a large trial, called PACE, involving 641 patients, costing £5 million. It was paid for by the Government and carried out by psychologists at Queen Mary University in London.
PACE found that patients being treated with the combination treatment — 14 sessions with a therapist over a six-month period — improved by 60 per cent, while the ‘recovery rate’ (which implied a ‘cure’) was 20 per cent.
But a new analysis of the data has suggested that patients experience just a 20 per cent improvement, and only 5 per cent are classed as recovered.
PACE TRIAL REANALYSIS
Dr Charles Shepherd…
‘This has cast serious doubts on the recovery rates being claimed,’ adds Dr Charles Shepherd, honorary medical adviser to the charity the ME Association (Dr Shepherd was also a member of the Chief Medical Officer’s Working Group on ME/CFS and the Medical Research Council’s Expert Group on ME/CFS research).
‘The trust of patients has been lost. PACE needs to be withdrawn.’
In fact, patient campaigners have been claiming for years that the psychological approach is profoundly wrong because it implies the problem is the way the patient thinks about it. They consider that they’re suffering from a physical disorder.
The re-analysis of the PACE data has set the cat among the pigeons. A challenge to evidence supporting a NICE-approved treatment is unusual, not least because the data was only made available after a protracted battle by patients.
Ever since its publication in The Lancet, the PACE trial had been questioned by patient groups. They wanted to see all the data the trial had gathered to check the statistics.
For five years patient advocates and some doctors sent letters and Freedom of Information requests to the researchers — Professor Peter White (of Queen Mary University of London), Professor Michael Sharpe (Oxford University) and Professor Trudie Chalder (King’s College London) — without success.
Grounds for refusal included risk of revealing patient identities and claiming the demands to hand over the data were vexatious or a form of harassment.
Indeed, one expert witness for the researchers drew parallels between these ME/CFS ‘activists’ and animal rights groups, suggesting there was a serious risk of violence to researchers if the data was released. But then the Information Commissioner’s Office became involved and the university was ordered to cough up the data. It refused and then spent more than £200,000 to have the order dismissed.
This was rejected by a tribunal (as for the claim of threats being made, under cross-questioning the expert witness admitted there hadn’t been any).
Professor’s Philip Stark, Bruce Levin, Jonathan Edwards and Simon Wessely…
When the trial data was finally re-analysed and checked by two independent academics, Philip Stark, a professor of statistics at the University of California, Berkeley and Professor Bruce Levine from the Department of Biostatistics at Columbia University, it ‘revealed that the study contained little evidence that CBT and graded exercise add anything to standard medical care in terms of patient recovery‘, according to Professor Levin.
This was backed by Jonathan Edwards, an emeritus professor of connective tissue medicine at University College London.
‘The results of the re-analysis shows that the call for access to the PACE data for independent analysis was justified,’ he said. ‘It confirms that this study failed to provide reliable evidence for useful, sustained benefit from either CBT or graded exercise therapy.’
Sir Simon Wessely, Regius professor of psychiatry at King’s College London, has long been identified with the psychological approach. When he was asked about the data re-analysis last year, he was quoted as saying: ‘OK folks, nothing to see here, move along please.’ He added that patients did improve and that the treatments were moderately effective.
COULD IT BE CAUSED BY INFLAMMATION?
At the heart of the issue is what causes ME. Patient activists and some doctors consider it a physical disorder.
This ‘biological’ theory appeared to be reinforced by recent research from Stanford University in the U.S. that identified a new set of ‘messenger’ molecules in the blood that are part of the immune system and behave differently in ME/CFS patients.
New, sophisticated equipment allowed a team to run a very detailed analysis of the blood of 192 patients, comparing it with nearly 400 healthy people.
They found that immune system messenger molecules (cytokines) that trigger inflammation and produce flu-like symptoms were higher in patients with the most severe symptoms.
An independent expert, Gordon Broderick, a systems biologist at Rochester General Hospital in New York, commented that it was a ‘tremendous step forward’.
ARTHRITIS DRUGS MIGHT HELP
The Journal of Health Psychology gave the original researchers the right to respond to the criticisms — they said they stood firmly by their findings, and that ‘the PACE trial… along with other studies provide patients, healthcare professionals and commissioners with the best evidence that both CBT and GET are safe and effective treatments’.
But what about the ‘biological’ theories of ME/CFS and the new research published recently suggesting a link with raised levels of molecules linked to inflammation?
Commenting, Dr Alan Carson, reader in neuropsychiatry at the University of Edinburgh, said what wasn’t clear is whether a higher level of these molecules ‘necessarily make you feel worse’.
He added: ‘It’s highly unlikely it will lead to a blood test any time soon.’
Yet Professor Edwards, who has described the PACE trial as ‘poorly designed, poorly executed and inappropriately interpreted’ believes that studies are needed.
‘Here in the UK we’ve spent far too much on the psychological aspect,’ he says. ‘Understanding the biology is what’s going to lead to an effective treatment.’
Professor Edwards, a rheumatologist, has previously found that patients with ME/CFS as well as rheumatoid arthritis reported great improvement when they were treated with the powerful anti-inflammatory drugs used for their arthritis. A trial of this is now under way.
Meanwhile, PACE continues to have support among psychiatrists and psychologists. It seems unlikely that it will be withdrawn, and so the struggle between the doctors and patients continues.
You can read the complete online version of the Daily Mail article, here.
Please note: The images used above are not from the original article as it appeared in the Mail Online.