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Letter to my MP about MAGENTA and NICE

I've just finished and sent a letter to my MP and felt like sharing it. It seems too long for a forum post, so I thought I'd have a go at copying it as a blog. I hope that's OK.

Dear Oliver Letwin,

I am a constituent of yours and have a serious issue I wish to draw to your attention and ask for your support in righting a major injustice to some very sick people.

I rarely write to you, but ask if you could please spend a little time personally informing yourself about an issue vital to me and others of your constituents, and use your expertise to help to right a serious wrong.

I have suffered from ME (myalgic encephalomyelitis, sometimes called CFS, chronic fatigue syndrome) for 26 years. After struggling to continue working part time as a college lecturer for many years while my ME was relatively mild, my health deteriorated 12 years ago and I was ill health retired. I am now housebound and care for my daughter who has ME also. My main symptoms are long lasting deep exhaustion after minimal activity with muscle pain and general malaise (headaches, nausea, sore throats, dizziness, concentration difficulty etc). I feel like I have bad flu all the time, made worse by activity.

There are estimated to be about 250,000 people with ME in the UK, ranging from those still able to work some of the time, to the 25% or so who are housebound or bed-bound. Some are so ill they have to be tube fed and need constant medical care. Many are not getting the level of care and support that someone with a similar level of disability with other conditions would receive because of the lack of understanding and misconceptions about the causes and appropriate treatment.

ME is a much misunderstood condition, but there is good scientific research ongoing, especially in the USA. Many studies provide evidence of systemic metabolic and functional abnormalities. For example a recent metabolomic study suggested a significant down-regulation of the energy production system in cells, (a bit like what happens in hibernating animals), making normal functioning of muscles, brain etc problematic. It is thought that this is a protective state triggered by an external cause, usually an infection, but that the body gets stuck in this state instead of switching cellular energy production back to normal. Other research has shown evidence of abnormalities in the brain, heart, muscles and the immune system.

I spell all this out because there is a serious problem with the way ME/CFS is understood and treated in the UK. About 30 years ago some psychiatrists hypothesised, on no evidence and without examining the patients, that outbreaks such as that at the Royal Free hospital in the 1950's were a case of mass hysteria. They developed a theory, sometimes called the biopsychosocial model which they applied to all medically unexplained symptoms including ME/CFS. They decided that the cause was false illness beliefs and de-conditioning, and they thought the treatment should therefore be to encourage patients to change these false beliefs using a version of cognitive behaviour therapy(CBT), and to prescribe graded exercise therapy(GET) to overcome de-conditioning. If the theory was correct, these treatments would, indeed be the logical approach, and should be very effective and cause no harm.

The NICE guidelines for ME/CFS, written in 2007, recommend CBT and GET, and clinics have been set up around the country providing them. I understand the treatments involve many sessions and cost the NHS thousands of pounds per patient. The NICE guidelines were written on the advice of the psychiatrists promoting CBT and GET before the large scale research set up to provide the evidence for them reported their findings. The two large trials funded by the MRC, Department of Health and DWP set up in the early 2000's to provide this evidence were called the FINE trial and the PACE trial.

The FINE trial on the more seriously effected housebound patients published its findings a few years ago and the result was clear. There was no difference in outcome between the treatment group and the control group. In other words the treatments didn't work for more severely effected patients.

The PACE trial on mild to moderately effected patients able to attend hospital clinics was published in 2011 with much fanfare orchestrated by the researchers, claiming 60% of patients improved with GET or CBT. This has been accepted by the medical profession as good evidence for use of the treatments, and doctors around the country and around the world tell their patients it's all in their heads and all they have to do is exercise. Patient groups protested that this did not chime with their experience, and that in fact many had been seriously harmed, some becoming bed-bound for months or years, by trying to exercise their way to health.

Recently the conduct and reporting of the PACE trial has been seriously questioned more widely by eminent scientists around the world, saying the conduct of the trial was so seriously flawed it should never have been published. For example, criteria for improvement and recovery were changed so drastically from the approved pre-trial protocol that a patient could be deemed recovered at the end by getting worse!

A freedom of information tribunal ruled last week that anonymised data from the trial should be released to a patient so the data can be re-analysed according to the pre-approved protocol criteria. The day before the data was due to be released the researchers released on their university (QMUL) website a re-analysis of some of the data, showing clearly that their claim of 60% 'improvement' was actually 20%, with the control group on 10%. This level of recovery on a questionnaire based outcome is no more than placebo effect. They still have not published the results for pre-defined 'recovery'. In other words they had grossly exaggerated their claims of success for the treatments. I think this can justifiably be construed as medical malpractice.

If a drug trial had such low success, I'm sure it would not be recommended by NICE especially when the outcome measures were based on subjective questionnaires, and are no better than placebo effect. Add to this the fact that the 2 year followup of the PACE trial showed null effect, ie no between group differences, and it is clear that these treatments are ineffective and should be withdrawn.

So the net result of both the FINE trial and PACE trial is that the treatments are ineffective for ME/CFS. Add this to the good scientific evidence that it is a serious multi-system disease, not a psychosomatic disorder, and the reported harms to patients of attempting to exercise when the metabolic energy production system is damaged, and it is clear that the treatments must be withdrawn with immediate effect before more damage is done to patients. I have been personally effected by taking the advice in the NICE guidelines and pushing myself to keep active, and have been advised by GP's to get more exercise, making my condition worse long term.

There is a particular urgency to this at present because a trial is underway of GET and CBT on children, conducted by Dr Esther Crawley who I understand is based at Bristol hospital. It is called the MAGENTA trial, and was justified and got approval on the strength of what has now been revealed to be fraudulent claims by the PACE trial researchers. Going ahead with the trial under these circumstances could be construed as negligence and medical malpractice. I think with horror of what might have happened to my daughter if she had been forced to undergo GET, as some children have been.

I am asking you to use your considerable skills to help get the MAGENTA trial stopped and to get the NICE guidelines changed.

I can provide you with links to documentary evidence of everything in this letter if you wish, and would be happy to talk to you about the issues I raise, though it would have to be in my home. There is also an ME APPG who could provide you with information.

This could be a opportunity for you to make a real and lasting change for good in many people's lives, and to save the NHS money on ineffective treatments, and the possibility of malpractice suits.

I look forward to your considered response.


Thanks Jaime, I know it's really too long. Too tired to edit down! I will post his response here.
As promised, here's the reply. No more than I expected. I've been slapped in the face with a wet fish!

Dear Mrs Davis,

Thank you for your email of 15th September. I am sorry for the delay in responding to you, but my Secretary was on leave last week.

I am afraid I do not believe that the best interests of patients with ME would be served by any attempt to base treatment on something other than the world-class evidence-based approach to clinical effects that is applied by the National Institute of Health and Clinical Excellence (NICE) to the evaluation for all proposed treatments for all conditions in the NHS.

With best wishes,

Yours sincerely,

Oliver Letwin

Well, a nice try trish, sorry your MP has to be Oliver.

Did he get knighted for leaving confidential waste in a public bin?

www.andycanning.mycouncillor.org.uk. is the web address for the Lib Dem Candidate for the seat if that's any use to you.

https://bridportlabour.org.uk/contact-us/ the contact address for the Labour Constituency Party.

I'm sure a quick send of your correspondence might interest them.

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