Monday, 25 September 2017
The SMILE Trial and Its Not-So-Happy Aftermath and Mutiny by ME sufferers forces a climbdown on exercise treatment
The SMILE Trial and Its Not-So-Happy Aftermath
A statement from Invest in ME Research
Invest in ME Research has never approved of the Lightning Process (LP) business and its model of operation where former 'recovered' patients pay a lot of money to become practitioners of this Trade Mark training programme.
We view this as a pyramid business – unregulated, unaccountable and unscientific.
Claims that it cures people with ME we find as risible hype.
Since 2010, we have made objections about the SMILE Trial  – an abhorrence in this age when we should be investing in biomedical research into ME in order to find causes for this disease.
Instead, funding is allocated to a commercial business enterprise to test it out on children.
It is shameful that any self-respecting researcher would participate in this.
It is disgraceful that any media outlet with any integrity would just take the press release of a media centre which is known for promoting a false view of ME and then avoid doing even the most basic of journalistic tasks – such as research of the information.
It is especially disgusting to witness the hypocrisy of some organisations who now complain about this training programme - yet all the while seem to be happy to sit in the same “big tent” along with the SMILE Trial PI, in a so-called collaborative organisation which continues to support this sea of research dross.
What a sickening spectacle! Any ME charity or researcher promoting this training programme, or working with the people that carry out this research, is doing a great disservice to ME patients.
On the day after what would have been the 40th birthday of a young woman, whose life was taken far too early by this disease, instead of remembering her ordeal we are, instead, treated to another media blitz from biased editors covering more junk research.
The lemming-like media in the UK perform their usual subservient role and unhesitatingly follow the propaganda issued by the Science Media Centre (SMC) and continue their usual discrimination against people with ME and their families.
Not for the UK media any rational analysis of why people with ME are frustrated for a generation by mindless junk research or by disingenuous spokespeople claiming to represent them.
Instead the media trot out the same lies about death-threats against researchers (normally only two) - yet ignore the plain fact that patient-funded research is thriving with researchers clearly enthused about the possibilities of finding the real cause(s) of this disease.
What the media should really look at is the IIMEC11 pre-conference dinner presentation by Kjersti Krisner .
This clearly shows what harm ignorance about ME can be done when vested interests manipulate and distort the true nature of this disease.
Then the media should follow up by viewing David Tuller’s IIMEC12 pre-conference dinner presentation .
Two presentations clearly showing the failings of establishment organisations and their supporters – and the misery dished out to people with ME.
Effect and Cause.
While Dr Esther Crawley - the SMILE PI – has been congratulated by the chair of the CFS/M.E. Research Collaborative (cmrc) for her stunning and amazing work;
while the chair of the cmrc may be “thrilled” that four years down the line from its inception his organisation merely has a room full of people at its meeting to show for that period – and is unable to avoid the realisation that this organisation has achieved nothing of significance;
while some are sitting happily in the establishment big tent alongside the SMILE Trial PI and do not see anything incongruous in that situation;
while some who never objected to the trial in the first place now seem to want to appear concerned;
while the establishment media centre pumps out more spin about ME,
while lazy journalists do no research on the subject and continue to act as puppets of biased media editors ;
while this entire circus continues people are suffering from this disease.
All of these years have gone past – and nothing has fundamentally changed regarding establishment policies towards research into ME it seems.
And the lives of patients roll by – with many who influence research policies for ME, and their supporters, seemingly oblivious to the waste of life, of opportunity, of any sense of really making a difference to families affected by this crippling disease.
The LP business has no place in serious research and cannot be researched seriously, as it tells people to keep its methods secret, to deny they have ME.
This alone should be a big red flag to anyone.
How funding could have been given to this in the first place ought to be a subject for the media to research.
These quick and dirty solutions to a society increasingly founded on soundbite healthcare will leave a trail of sick patients and despairing carers, and a tragic dystopia.
And everyone, save for perhaps the business practitioners, will be the poorer for it.
4. Crawley EM, Gaunt DM, Garfield K, et al Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial Archives of Disease in Childhood Published Online First: 20 September 2017. doi: 10.1136/archdischild-2017-313375
Apart from the last two paragraphs, it’s encouraging to see this in The Times today -
The Times: Mutiny by ME sufferers forces a climbdown on exercise treatment
By Tom Whipple, Science Editor, The Times, 25 September 2017.
A patient revolt in collaboration with MPs and academics has led to a major review of NHS guidelines on the treatment of ME.
The reassessment of recommendations for the condition will consider the validity of a £5 million taxpayer-funded trial that claimed sufferers could be helped by simple lifestyle intervention.
About 200,000 people in the UK suffer from myalgic encephalomyelitis (ME), also sometimes known as chronic fatigue syndrome (CFS). Its symptoms include debilitating tiredness, joint pain and concentration problems, and its causes are poorly understood.
In 2011 a UK study published in The Lancet found that patients could experience significant improvements through exercise and cognitive behavioural therapy. Its findings have since formed the basis of treatment in the UK and abroad.
However, patient groups claimed that the interventions made them worse and argued that the treatment wrongly implied it was a psychological, rather than biological, illness. Some academics agreed.
In an open letter to The Lancet, more than 40 academics from UCL, Stanford, Columbia and University of California, Berkeley, among others, argued that the trial had “major flaws”, which included changing its criteria for patient improvement midway through.
They said that this was of particular concern “because of its significant impact on government policy, public health practice, clinical care and decisions about disability insurance and other social benefits”.
The severity of CFS means people are often unable to hold down jobs or live normal lives.
Keith Geraghty, from the University of Manchester, said that the apparent improvements in some patients could be better explained by initial misdiagnosis, and that the benefits were marginal. “The problem is, if you look at patients when you do nothing there is a similar level of recovery,” he said.
Because the criteria for measuring recovery was changed, it was also not clear what recovery even meant, he said. “It became farcical because once they did that patients who began the trial as sick could have been deemed recovered when they started.”
The debate about the trial has become one of the most acrimonious in science, with both sides claiming they have been abused by the other. The US has now changed its recommendations.
The National Institute for Health and Care Excellence (Nice) has been receiving strenuous lobbying to do the same, and this month pressure was increased when 30 MPs signed an early day motion urging a review.
This week Sir Andrew Dillon, chief executive of Nice, said that it would carry out a full review, expected to report back after 2020.
Trudie Chalder, professor of cognitive behavioural psychotherapy at King’s College London, was one of the authors of the original 2011 Lancet paper. She welcomed the review and said that subsequent trials showed that exercise and cognitive behavioural therapy remained the best treatment.
“There have been several well conducted trials from independent researchers showing that rehabilitative treatments such as cognitive behavioural therapy and graded exercise therapy improve people’s lives,” she said. “Professionals who provide evidence-based treatments need an update on the state of play.”
Read the article in The Times.