Tom Kindlon is a strapping six-footer, yet his physical presence belies the reality he is forced to live with every day. He can only stand for just 30 seconds before feeling dizzy, and his mother, Vera, is his full-time caregiver in the family home near Dublin, Ireland. As he can’t stand in the shower, she has to give him bed baths. “I know I only have so much energy and have to be cautious how I use it; I haven’t read a fiction book in over 20 years,” says Tom, 44.
He was diagnosed with CFS/ME (chronic fatigue syndrome/myalgic encephalomyelitis) in 1994, around the time when there was a sudden surge in cases of this mysterious condition. “I can remember how it happened. I developed an infection the day before going on a school trip when I was 16. I decided to still go. We went to an adventure centre, canoeing, hill-walking, abseiling and orienteering. It was February and it was cold and rainy throughout the trip—not the place to be when you’re unwell. I was ill for some days after I came home.”
That was the last time Tom was to feel well. He was able to struggle through the rest of school and university, but always felt tired and his muscles ached. He went to see an orthopaedic surgeon, who recommended exercise, so he started swimming three or four times a week.
But he often had muscle strain afterwards, and after exams at college, he suffered a major relapse, which included a constant sore throat, high temperature and pain in his lower stomach.
A gastroenterologist diagnosed irritable bowel syndrome but, eventually, a consultant pinpointed his problems to ME, or post-viral chronic fatigue syndrome; Tom was a classic case, he said.
Tom was one of the lucky ones; at least he got a diagnosis that recognized a physical cause of his problems. Many were told they had ‘yuppie flu’, a pejorative way of saying they were lazy or attention-seekers.
Doctors tended to agree that CFS/ME was more in the mind of the sufferer, a view shared by their official body, the Royal College of General Practitioners. In fact, it was only as recently as 2008—after much pressure from ME support groups—that it stopped classifying CFS as a mental disorder.
That was a watershed moment. With such acknowledgement, researchers started to see it as a genuine physical problem and began looking for the virus that might be the trigger.
Then in 2011 came the PACE study. This was a game-changer. It was the largest CFS treatment trial ever undertaken, costing £5 million, some of which came from the UK government’s Department for Work and Pensions (DWP), a
strange benefactor and one that, in hindsight, offers a clue as to where the study was going.1
Another clue was the particular team of researchers assembled to carry out the study. Even before the landmark PACE study, they had published hundreds of papers on the problem and were all of a similar mind: yes, it starts with a viral infection that can cause exhaustion and fatigue, but instead of recovering, the sufferer develops “unhelpful beliefs” that stop him resuming a normal life. They were all advocates of the ‘talking therapy’ CBT (cognitive behavioural therapy), which encourages CFS patients to stop having these limiting beliefs.
Lead author Peter White, from Queen Mary University of London, and two other PACE researchers, Michael Sharpe from Oxford University and Trudie Chalder from King’s College London, are all followers of Simon Wessely, a professor of psychological medicine at King’s, who pioneered the use of CBT and graded exercise for CFS sufferers.
The PACE researchers set out to test the Wessely protocols: they gathered together 641 CFS sufferers, who were divided into three groups for either graded exercise, CBT or ‘adaptive pacing therapy’ (APT), which assumes that CFS has a physical cause that can’t possibly be treated, so the sufferer’s life has to be modified accordingly. CBT set out to overcome the sufferer’s fear of physical activity, or ‘fear avoidance’, as the researchers called it.
After a year, exercise and CBT were ‘moderately’ successful in improving CFS symptoms, but APT had no positive impact, suggesting that CFS is not a physical problem. In a press conference when the paper was published, Chalder was more emphatic. She said that “twice as many people on graded exercise and cognitive behavioural therapy got back to normal” compared with results from previous trials.
CBT is the way
The trial caused a furore. The press was quick to tell CFS sufferers to get out of bed and start exercising, and GPs began to adopt the Wessely approach. America’s Centers for Disease Control and Prevention (CDC)—which had collaborated with White and Sharpe for decades—and the UK’s National Health Service welcomed the sea change, and wanted to see CBT adopted as the standard care model for CFS.
It was good news as well for the UK’s cash-strapped DWP, which was paying out millions of pounds in benefits to the country’s 250,000 CFS sufferers. And remember, the department was one of the PACE trial funders. Under conflict-of-interest guidelines, some of the researchers had to reveal that they were paid consultants to insurance companies, who were also paying out to CFS sufferers. As such, for years they had advised insurers that CFS sufferers could return to work after a course of CBT.
In a report to insurer UnumProvident, Michael Sharpe criticized the “ME lobby” for influencing sufferers such that, as a result, “the patient’s beliefs may become entrenched and be driven by anger and the need to explain continuing disability”.
Sharpe concluded: “A strong belief that one has a ‘medical disease’ and a helpless and passive attitude to coping is associated with persistent disability. The current system of state benefits, insurance payments and litigation remain potentially major obstacles to effective rehabilitation.”
Show us the data
Not surprisingly, none of this was sitting well with CFS sufferers. Back in Dublin, Tom Kindlon read and reread the study, unable to believe the results that were completely contrary to his own experience. He wasn’t the only one: CFS sufferer Alem Matthees, in Australia, was so shocked by the findings that he asked the researchers to release the data on which their conclusions were based.
Independent researchers agreed. Six scientists from Stanford University wrote to The Lancet, which had published the PACE study, demanding a full independent investigation, and their letter quickly garnered 42 further signatories when the journal refused
David Tuller, academic coordinator at the University of California at Berkeley’s joint masters programme for public health and journalism, analyzed the study and concluded it was fraught with problems. For one, 13 per cent of the participants had already “recovered”—according to the criteria used by the researchers—even before the trial started. Halfway through, the participants were given a newsletter full of glowing testimonials for the therapies they were receiving, and then the researchers relaxed the protocols for assessing physical function and fatigue. Finally, determination of whether the participants had recovered was entirely subjective and not backed by any objective measures.2
Responding to the criticism, the researchers shared some of their findings—and the underlying data—with a few select academics, and then ‘went public’ with a new analysis of the original data that seemed to only add to the belief that CFS is a mental disorder. The participants who hadn’t improved were simply afraid of exercise, they said.3
Yet, the only way to end this controversy was to make all the data available for independent researchers to review—and this the Queen Mary University of London researchers refused to do. Matthees pushed his demands and made a formal request through Freedom of Information legislation for them to release the data.
A tribunal agreed and upheld his request. The PACE researchers resisted and hired a crack legal team for £200,000 to defend their corner. “The inevitable conclusion is that they have something to hide,” said former British Medical Journal editor Richard Smith.
The case went to an appeal, but again the second tribunal insisted that the researchers release their data. They swept aside protests from the researchers that doing so would reveal the identities of the original participants. As they had already shown the data to a small select group of researchers, they must have already felt confident that the participants’ privacy wouldn’t be compromised.
Sociopaths and psychopaths
The researchers then tried another tack, this time claiming that their critics were “young men, borderline sociopaths or psychopathic”, but as these critics included scientists from Stanford University, the appeals tribunal dismissed the claim as “speculative”.
At this point, the researchers also claimed that they had been threatened and harassed, but under cross-examination, they eventually conceded that “no threats have been made either to researchers or participants”.
An independent team of researchers has reviewed the data to discover that the PACE team had inflated the benefits of CBT and exercise threefold. Just 21 per cent of patients, and not the 61 per cent announced by the study, benefited from CBT, and 10 per cent of those who had no treatment also reported improvements in their symptoms.
Had the true benefits of CBT been reported at the time, the standard therapy may not have changed, and doctors would have agreed that ME truly isn’t all in the head.
What’s in a name?
Around 2.5 million Americans and 250,000 Britons suffer from CFS (chronic fatigue syndrome). Scientists are perplexed; some say it’s characterized by immunological and neurological dysfunction but, recently, researchers at Cornell University have found biomarkers in the gut bacteria and blood inflammatory agents in CFS sufferers. Just by using these markers, the researchers were able to successfully diagnose 83 per cent of cases.1
After an early outbreak at a London hospital in the 1950s, the doctors then came up with the term ‘myalgic encephalomyelitis’ (ME) to describe the condition, which caused extreme muscle fatigue after even slight exertion.
When a similar outbreak happened in the US in the 1980s, American doctors preferred the term ‘chronic fatigue syndrome’.
Today, the US calls the condition ME/CFS, while the UK puts it the other way round. Both are wrong, says the US Institute of Medicine (now the National Academy of Medicine), which instead suggests ‘systemic exertion intolerance disease’, or SEID.