From the ME Association website –
Government-funded ME/CFS trial ‘one of greatest medical scandals of 21st century’ | 20 February 2018
A controversial medical trial part-funded by the Department of Work of Pensions will emerge as “one of the greatest medical scandals of the 21st century” an MP today claimed.
A trial which claimed exercise helped the estimated 250,000 sufferers of the devastating illness, M.E., (myalgic encephalomyelitis) to recover was deliberately flawed to “remove people from long-term benefits and reduce the welfare bill”, a parliamentary debate heard.
Manifesting as unrelenting fatigue and profound pain, the condition, also known as chronic fatigue syndrome, has no known cure and is made worse by exertion.
Sufferers are often confined to their beds, unable to walk, and need help even to shower – an action that could then lay them low for hours, days, weeks or longer.
More than just bad science
When the PACE trial was published in 2011, researchers claimed that graded exercise therapy (GET) and cognitive behavioural therapy (CBT) were “moderately effective” forms of treatment.
But the trial has faced intense criticism from patients, charities – such as the ME Association – clinicians and researchers, over how the results were obtained, analysed and presented.
After a long legal battle, unpublished data from the trial was released and, when independently analysed, it showed no difference between the different treatments being tested and that reported recovery rates had been grossly inflated.
And in surveys carried out by the ME Association, more than half of patients who had followed the recommended graded exercise programme saw a worsening in their symptoms.
Carol Monaghan, the SNP MP for Glasgow North West, worked with the ME Association to hold the debate in Westminster Hall today, and had received nearly one thousand letters and emails from people affected by the condition.
She said: “The failure of PACE… could simply be put down to bad science. But unfortunately, I believe there is far more to this.
“One wonders why the DWP would fund such a trial, unless of course it was seen as a way of removing people on long-term benefits and reducing the welfare bill.”
Westminster Hall heard how people with M.E. struggle to obtain benefits because of treatment guidelines, which wrongly suggest that exercise can lead to recovery.
Former science teacher Ms Monaghan also told how a lack of medical education was leading to late and inaccurate diagnosis – along with absent, inappropriate or even harmful management advice – and that the M.E. field was plagued by a “woeful lack of research”.
She said: “Labels such as chronic fatigue syndrome and post-viral fatigue syndrome simply do not come close to the living hell experienced by many sufferers. A living hell made worse by a lack of understanding towards those seeking help.”
Complete rethink required
Speaking after the debate, the MP said: “The PACE trial was fundamentally flawed as it worked from the assumption that M.E. is a psychological condition.
“To describe somebody with M.E. as suffering from ‘fatigue’ is a gross misrepresentation of the symptoms they experience: debilitating muscle pain, excruciating headaches and exhaustion so severe that some sufferers cannot even chew solid food; is the reality for a person with M.E.
“There has to be a complete rethink of the medical advice given to sufferers of M.E. as even gentle exercise can set them back for weeks and, in some cases, months.
“However, unfortunately for many this is still the advice being offered. Discovering that the PACE trial was funded by the DWP, no doubt with the intention to reduce the amount of people on benefits, should cause great concern.
“As a scientist, I am appalled by the methods used in the trial, which included changing the parameters and success criteria midway through the study. This has been widely discredited in the research community.
“I hope that this debate will be the starting point for new medical advice and guidelines for people suffering from ME. I thank all of those who have taken the time to get in touch with me regarding their personal experiences of both living with M.E. and the PACE trial.”
Listen to what patients have to say
A spokesman for the ME Association, which campaigns for more awareness into the condition, said:
“It is vital the voice of M.E. patients is heard, and we are grateful that their plight, and the flawed PACE trial, has been raised today.
“Many of our members are housebound or bedbound and we cannot allow them to be forgotten about by society.
“Many have seen a worsening in their symptoms after undergoing CBT and GET and it is vital that this advice is no longer given out by medical professionals.
“M.E. patients are not hypochondriacs, hysterical or lazy – they are afflicted with a condition that is devastating and life-changing.”
The PACE trial data was used justify NHS recommendations of exercise and cognitive behaviour therapy and no changes were made as a result.
But a patient revolt has forced the government and NICE (the National Institute for Health and Care Excellence) to review the guidelines used by UK doctors. That review may not be completed before 2020.
An ME Association spokesman added: “We hope that NICE and the NHS will continue to listen to patients and adopt only practices that can truly help people with M.E.”
The government said it wants to put patients at the forefront of any new guideline and said it welcomed high-quality medical research applications into M.E.
For more information about M.E., visit meassociation.org.uk. For press enquiries, contact 07598032845.
For enquiries to Carol Monaghan MP, email firstname.lastname@example.org
To watch the recording of today’s debate at Westminster Hall, visit parliament.tv – it was heard from 11.00-11.30am.