Discussion in 'Action Alerts and Advocacy' started by Countrygirl, Nov 3, 2016.
Here is the application for FITNET.
Interesting selection of co-applicants, including a number of the Dutch researchers who view ME as a condition with no organic cause, and Mary-Jane WIllows.
She quotes PACE as evidence that CBT is successful.
She forgets to mention that the Dutch trial produced a null result at 2 years follow up.
Those children with 3 months of disabling fatigue plus one symptom  (NICE guidance) will be eligible.
Not ME then.
There is no way of knowing, as far as I can tell so far, how many of the fatigued children have ME as PEM is not required. Some will, but they may well be in the minority, based on the definition here of CFS/ME
This stuff is lifted straight out of the Dutch study protocol. Probably a cut-and-paste job.
If I have interpreted this correctly, as relapses are expected as they are characteristic of the illness, they won't be recorded. So, could this mean if a child becomes bedridden during the course, that this won't be noted as an adverse event?
Gird your loins!
It sounds like the results are already in. Is this considered appropriate language at the outset of a "scientific" trial.
Shame that the MIA will be unable to respond.
The problem here is that the word "unexpected" is highly loaded, and extremely subjective. If the raw data were to be made available, then independent peer reviewers could apply independent assessment of what is unexpected or not. It is also very worrying to see "will not be reported to the sponsor", implying no raw data will be released, and that FITNET's published results will be all anyone gets to see. It is breathtakingly crass, given PACE.
"We will inform NICE of the trial results so that results can be included in updated guidance."
@charles shepherd might this mean putting of revision of the NICE guidelines until 2022?
I dont understand how this study then has even been approved. How on earth can one get away with doing a treatment study for an illness and then not reporting if the illness is being made worst by the treatment?
well thought out. I would guess that they could get the NICE guidelines revision put off if they go on about how info backing the current guidelines isnt far off if they are held off of revision for a while.
I see so much bad things with this study. I guess its supposed to keep the seriousness of ME/CFS buried due to the recent exposure of PACE.
It's the UK.
Re the 'expected adverse events', my reading of this is that these will be recorded, but that only non-expected events have to be reported to the trial sponsor. So the data should be there under expected adverse events - but how they choose to report this is another matter. I'm presuming that the expected events will all be lumped together, with no way of telling how serious they are for individuals, and some kind of statement made about how nothing serious happened....
Which is why open access to the raw data is especially crucial. The very fact that "expected" adverse events will not be reported, leaves the door wide open for any published results to mask/obscure such issues that the data itself may hold. If the research was in the hands of highly trusted researchers, would not seem such a worry. It is only very recently that I have become aware of clinical trials' practices, and I am flabbergasted by what seems to be the accepted norm. Sane checks and balances just do not seem to be there.
This seems incredibly presumptive/arrogant to me. Do all trials presume at the outset, that the outcome will be sufficiently successful and worthwhile as to be incorporated into a nation's official clinical guidelines? Or is it just here in the UK?
I'll going to make a psychic prediction , I predict that there will be people trying to get the raw data for this study as everyone of us will want to know about those unreported "expected" side affects they dont want to report. Can I also predict that withholding of data will be tried again here.
We can see from the start that this study is going to be done to try to hide the truth. umm and surely they know that there will be freedom of info requests on that raw data to find things like this out, so that makes me really wonder how they will deal with this?
Maybe they wont record the expected adverse events as surely they will know we will get that info so they could decide its more better for them not to report then have that reported with results which would come out. Unless they are dumb enough to continue to try to mislead, thinking that people wont go to court to try to get it?. or maybe that info will be said to have gone "missing" later on. I've seen "gone missing" corruption before. (is there any steps which could be taken to ensure this info doesnt go missing?)
If anyone running that study reads this post.. all I can say is you'd best get a plan in place as the ME community isnt going to keep allowing biased studies to keep misleading and we will be working to expose anything hidden. The more you try to hide things and deceive, the more obvious it is becoming to us that things are being hidden. You'll be a fool to keep continuing to believe you can get away with this.
I so hope that a court case people are trying to do, can go ahead for that deceptive PACE trial as that will make those others doing deceptive studies think twice about what they are doing.
they already probably have this all stitched up and know exactly what result they wish to come up with and now are probably just planning how exactly they will achieve this desired result. Will we see more study chances mid trial so they can achieve this when things arent working out right for them?
I am racking my memory cell for the name of a document that I read yesterday and intended to post here that has relevance to Barry's observation. I have hunted for it but can't find it. It made reference to the bodies that are funding FITNET and I recall some surprise at finding that the results of the trial are destined by the funding body for NICE and'or other government guidelines. Prof Michael Sharp is part of the organisation who allocated the grant.
Maybe given the nature of the organisation that is funding FITNET and the planned destination of the 'results', it explains why the conclusions have already been announced before the trial has begun. Sorry to be so vague, but maybe someone else also saw the document yesterday. The rest of it quoted chunks of Margaret WIlliam's most recent piece.
It shouldn't too difficult to hunt down or just check the background and purpose of the funding bodies.
Professor Sharpe's connection with FITNET is as the senior investigator for the National Institute for Health Research who have awarded EC the grant. See his description below, although it frustratingly doesn't provide the information I read yesterday. I will post it later if I find it again.
NIHR Senior Investigator
Psychiatric aspects of medical illness and treatment
My research aims to understand the psychiatric aspects of medical illnesses and their treatments, to develop novel interventions for these that are integrated with medical care and to evaluate these in rigorous clinical trials.
My current interests are in developing integrated medical-psychiatric treatments and services especially for people with depression that is comorbid with medical conditions such as cancer and for elderly medical inpatients.
I am a Fellow of the Royal Colleges of Physicians of London and Edinburgh and of the UK Royal College of Psychiatrists.
I serve as a member of the governing council of the American Academy of Psychosomatic Medicine (APM) and as a member of the executive of the European Association of Psychosomatic Medicine (EAPM). I am theme lead for medical-psychiatric multi-morbidity in the Oxford NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC).
You can also try a Google Site Search
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