Major charities and individuals have joined WAMES in expressing concern about the nature of the FITNET trial being run by Prof Esther Crawley, the lack of objective analysis in the media coverage and the questionable results from the original Dutch trial.
WAMES does not support the FITNET trial. We do not believe it is a good use of public money. Patient surveys and poor results from the PACE trial raise questions about the effectiveness (and safety) of CBT and GET in adults. The Dutch trial in children with fatigue did not produce better long term results than usual care and it is unclear whether all participants had strictly defined ME.
WAMES recommends caution for young people with ME participating in the ‘intensive activities’ that the FITNET trial requires, as post-exertional exacerbation of symptoms, is the key characteristic of ME.
ME Association, 1 November 2016: ME Association comments on today’s news reports about the online CBT Trial for children,
THE UNACCEPTABLE FACE OF ME/CFS NEWS COVERAGE
Finally, to return to the BBC press coverage this morning, whilst it was encouraging to note that while it was being stressed on several occasions that ME/CFS has a biological basis/cause, it was completely unacceptable to then find that news bulletin coverage on BBC Radio 2 was then referring to an illness that caused children to miss school and have mental health problems. Read the full article
Action for ME, 2 Nov 2016: New FITNET trial announced for young people with M.E.
November 02, 2016
There has been considerable media coverage of the trial, which began recruiting yesterday, though results are not expected for a number of years. Some coverage has suggested that M.E. leads to “mental health problems and missing school” (BBC news), which considerably underplays the devastating effects of M.E. on children and young people with the condition and their families.
Nor should the inclusion of a psychological therapy in the trial be taken as evidence that M.E. is psychological in origin. It is not. M.E. is a chronic, fluctuating, neurological condition that causes symptoms affecting many body systems. Research shows that people with M.E. score lower overall on health-related quality of life tests than most other chronic conditions.
Action for M.E. does not recommend or endorse any individual treatments or management approaches for people with M.E., but instead provides key information to empower those affected by M.E. to make informed decisions.
CBT is not a cure for M.E. but some people with M.E. tell us it helps them cope with the impact of the illness. In 2014, we surveyed more than 2,000 people with M.E and our resulting M.E. Time to deliver report showed that 33% of respondents had tried CBT and of these, 54% said they found it helpful or very helpful, 34% said it resulted in no change, and 12% said it made them a bit or much worse. However, almost all of those surveyed were adults.
Sonya Chowdhury, Chief Executive, Action for M.E., says, “Media coverage has repeatedly described 63% of patients being cured in the Dutch study, but this is misleading, and fails to take into account the long-term effects of M.E.”
Additionally, it is important to note that there has been no reference to a follow-up study that was undertaken by the Dutch FITNET team. This found that, at long-term follow-up (an average of 2.7 years), there was no difference between the recovery rates for the different treatment strategies (FITNET versus any form of usual care) although recovery, as reported by the study, was eight times slower for those not using the FITNET treatment strategy. The results of the UK study are unlikely to be published for six years. Read the full article
Utting-Wolf spouts: PACE part II? Esther Crawley and FITNET
…Costing £1 million, we yet again see large sums of money being spent on studies promoting the biopsychosocial (BPS) model of the disease rather than decent biomedical research. Crawley’s trial draws on a Dutch study which showed no difference between treatment cohorts at long term follow up[2], though the BBC and their scientifically illiterate journalists imaginatively and dishonestly spun this as a 2/3rd cure rate.
Again the laziness and uncritical reporting of any story concerning ME, promoted as usual by the Science Media Centre (SMC), by the UK media is glaring. They even dragged out their old canard, supposed victimisation of the brave researcher (that would be Crawley) by nasty ME activists, said researcher ‘heroically’ carrying on despite abuse from a minority of patients. Such claims were conclusively debunked by the recent First-Tier tribunal Judgement, which ordered the release of the PACE trial data but apparently no one told the BBC.
Today’s coverage of FITNET cannot be treated in isolation and should be compared with earlier reporting of the PACE trial by the British media, which was unfailingly enthusiastic, one-sided and uncritical. Both trials have been strongly promoted by the SMC, whose press releases are repeated more or less verbatim by the media, without any attempt to investigate the accuracy of their claims. This is possible in today’s media due to a combination of laziness, establishment cronyism and a lack of scientific understanding amongst journalists reporting on these issues.
The extensive coverage of studies promoting the BPS model of ME is in stark contrast to the virtual non-reporting of any biomedical research. The failure of the media to cover the recent dismantling of PACE, extensively covered elsewhere but barely mentioned in the UK press, was particularly revealing. One would think there was a media blackout, with such coverage as there was focused more on defending the PACE researchers than exposing their fraudulent study.
Had the media noted the flaws in PACE and the reasoning that underlines such studies so they might have been able to interrogate Crawley regarding the potential flaws in her study. The fact that the participants in the FITNET study will be children, makes it more morally questionable, though her focus on fatigue as the primary symptom suggests many trial subjects probably won’t have ME, as was the case with PACE. No doubt this will flatter her results if/when they are published, not always guaranteed with Crawley as demonstrated by the SMILE trial.
… it has been brought to my attention that James Gallagher, the BBC’s Health Editor who so enthusiastically promoted FITNET, is on the advisory committee of the Science Media Centre that controlled today’s coverage (and pretty much all media reporting relating to ME). I don’t remember his pointing out this potential conflict of interest and I shall be making a formal complaint to the BBC… Read the full blog post
i news post by Scott Jordan Harris, 1 Nov 2016: CBT won’t cure my chronic fatigue, any more than it would cancer – it’s a physical illness
My CBT helped me immensely in that it gave me mental strategies to cope with the physical limitations of my life. I hope it can help others in the same way. But the idea that CBT is a treatment for ME itself is dangerous and unhelpful.
What ME-sufferers in the UK really need is not talking therapy but well-funded, and properly conducted, biomedical research. And the truth is that, when it comes to ME, Britain is a backwater.
As American medical journalist Miriam E. Tucker tweeted from an international conference on ME in Florida last week: “Striking disconnect between the high-level science here at #IACFSMEConf vs. attitude toward ‘chronic fatigue syndrome’ in the med[ical] community.” Read more
Epigram, by Emily Faint, 2 Nov 2016: Backlash for ‘landmark’ University research trials
Interestingly, psychologists Trudie Chalder and Peter White, researchers in the PACE trial questioned the results of the original Dutch FITNET trial back in 2012: Chronic fatigue syndrome: treatment without a cause
What were the limitations of the trial? The main difficulty in the interpretation of the impressive out-comes in this trial was to understand the differences between FITNET and usual care. We are given little information about usual care beyond a brief summary of treatments received by participants. This lack of information means that the different outcomes might have been due to differences in dose (number of sessions or contacts), frequency or duration of the interventions, the involvement of parents in FITNET but not usual care, or some other difference that was not measured.
The other main issue is how to define recovery from an illness that includes symptoms that are sometimes reported by healthy people.8 The investigators defined recovery post hoc. However, the criteria used to define recovery were not stringent and some individuals who entered the study were already attending school fairly frequently. The investigators also used liberal criteria, such as the population mean plus two rather than one standard deviation, as their thresholds for recovery by continuous measures such as fatigue.
Therefore, the 63% of patients reported as recovered might have included those who had a significant improvement rather than being fully recovered. This proportion of patients does not detract from the still impressive difference from the 8% of participants who were judged to be recovered after usual care. Read full comment
