Monday, December 12, 2016

Psychologist Prof Coyne: PACE trial's CBT for ME/CFS is condescending pseudoscience

Psychologist Prof Coyne on #PACEtrial's CBT for #MEcfs: condescending pseudoscience presented to convince patients that their problems were in their heads

from Danish RCT of cognitive behavior therapy for whatever ails your physician about you | Mind the Brain http://blogs.plos.org/mindthebrain/2016/12/07/danish-rct-of-cognitive-behavior-therapy-for-whatever-ails-your-physician-about-you/

Saturday, December 10, 2016

Sir Simon Wessely (the godfather of PACE): The PACE trial simply made whatever adjustments they needed in order to get the results they wanted



Sir Simon Wessely (the godfather of PACE): The PACE trial simply made whatever adjustments they needed in order to get the results they wanted

By spoonseeker 9 December 2016:

  As for the PACE authors themselves, I doubt that anything will make a difference. They had clearly decided how the trial was going to turn out before they even started it, and I can’t see anything changing their views about it now, whether peer reviewed or otherwise.

PACE was not a voyage of discovery. As the godfather of PACE, Sir Simon Wessely, inadvertently revealed, they always knew exactly where they wanted to get to.

They simply made whatever adjustments they needed in order to get there. They live in a world where they are right, patients are wrong, and the facts can be changed to support that. I doubt they’re open to any kind of reason.

Or as Professor Steven Lubet, a Professor of Law at Northwestern University, recently stated:

"Finally, you point to your own blog post, which ironically undermines your very point. You compare the PACE Trial to an ocean liner plotting a course from Southampton to New York, and express satisfaction that it made the trip “successfully across the Atlantic,” despite course corrections along the way. 

But surely you realize that a randomized controlled study is not supposed to have a fixed destination, but rather should follow wherever the evidence – or the current, to maintain the metaphor -- leads. 

You thus virtually admit that the PACE Trial was always intended to reach a particular result, and that adjustments along the way were necessary to get it there.  Just so."



Monday, November 21, 2016

LSE: The medical and psychiatric establishment has to admit and apologise for abusing ME/CFS patients

LSE: The medical and psychiatric establishment has to admit and apologise for abusing ME/CFS patients

  LSE, 21 November 2016:

  "the psychiatrisation of conditions like Myalgic Encephalopathy/Chronic Fatigue Syndrome (ME/CFS) where organic and physical conditions become ‘all in the mind’. Here, whilst there is a complex inter-relationship between the mind and body, psychiatric reductionism has resulted in a catalogue of instances of maltreatment, neglect and abuse."  

  "The medical and psychiatric establishment has yet to come clean, admit to or apologise for these abuses."

 

Friday, November 11, 2016

The inaugural Dr. Speedy health award goes to ...

The inaugural Dr. Speedy health award for a lifetime dedication to improving the health and quality of life for people with ME/CFS goes to a man who has taken on the mighty Pinocchio Psychiatrists; a fight based on scientific evidence, an essential part of modern day evidence based medicine against people who have ignored all scientific evidence for decades (even if they have produced it themselves) and have made a fortune out of opinion, non evidence-based medicine .

And the winner is, yes yes yes, Tom Kindlon. Congratulations Tom from everybody at the Dr. Speedy Network of Clinical Excellence, a well-deserved award.


PS: Please do not confuse us with NICE from the UK: the National Institute of ignoring Clinical Evidence

Tuesday, November 8, 2016

Bogus FITNET trial is a GET trial in disguise being tested on children who don't have #MEcfs



Bogus FITNET trial is a GET trial in disguise being tested on children who don't have #MEcfs

FITNET trial is an unblinded trial (not a RCT) using subjective outcomes which uses their own "ME/CFS" criteria so that they can select patients who do not have the disease but then label them as if they do ...

Which is not surprising as Crawley, Bleijenberg and Knoop are involved who make Diederik Stapel look like an honest man. Pinocchio research from Britain and Holland. And the medical councils are still hibernating.

If you want to make yourself sick have a look at their protocol but make sure that you've got a bucket ready or better still ask your GP for an antiemetic before you read it. You will need it.



Monday, October 31, 2016

Breaking news: Cause of ME/CFS is in the blood


By Cort Johnson (@CortJohnson) tweeted at 1:18 PM - 29 Oct 2016 live from the ME/CFS conference in Florida: #IACFS/ME #ME/CFS: ME/CFS cells put in healthy serum do fine; healthy cells put in ME/CFS serum poop out - something in the blood is cause (http://twitter.com/CortJohnson/status/792196306072633345?s=17)

Sunday, October 2, 2016

Does "the President of The Royal College of Psychiatrists condones what is widely considered to be scientific fraud?"



Posted on behalf of Margaret Williams:
Simon Wessely is at pains to distance himself from involvement with the PACE trial, but once again he seems to have overlooked the facts.
The Trial Identifier is clear:
“Section 4. TRIAL MANAGEMENT
4.1 WHAT ARE THE ARRANGEMENTS FOR THE DAY TO DAY MANAGEMENT OF THE TRIAL?
The trial will be run by the trial co-ordinator who will be based at Barts and the London, with the principal investigator (PI), and alongside two of the six clinical centres. He/she will liaise regularly with staff at the Clinical Trials Unit (CTU) who themselves will be primarily responsible for randomisation and database design and management (overseen by the centre statistician Dr Tony Johnson), directed by Professor Simon Wessely, in collaboration with Professor Janet Darbyshire at the MRC CTU.
4.4. WHAT WILL BE THE RESPONSIBILITIES OF THE NAMED COLLABORATORS?
Prof Simon Wessely will oversee the CTU”
It also needs to be recalled that the post of Statistician Clinical Trials Unit Division of Psychological Medicine Ref No: 06/A09 was described as the “Johnson_Wessely_Job” (07/07/2006) at The Institute of Psychiatry where: “The team works under the direction of Professor Simon Wessely, the Unit Director. The team is supported by the regular input of a Unit Management Group from within the Institute of Psychiatry. The statisticians within the Unit also have regular supervision meetings with Dr Tony Johnson from the MRC Clinical Trials Unit. The post holder will be directly responsible to the CTU Manager (Caroline Murphy), supervised by the CTU Statistician (Rebecca Walwyn) and will be under the overall direction of the Head of Department, Professor Simon Wessely”.
So please, Professor Wessely, stop dissembling, as you are fooling no-one but yourself.
Despite the fact that post-hoc changes showed reported results that were up to five times better than those derived from the original protocol, you continue to defend what has been described by many as “fraud” in the PACE trial.
Can it be said that the President of The Royal College of Psychiatrists condones what is widely considered to be scientific fraud?





Friday, September 30, 2016

Classical case of projection: PACE trial's Peter White accuses Prof Stark and Levin and Matthees, Kindlon and Maryhew of scientific misconduct

Classical case of projection: PACE trial's Peter White accuses Prof Stark and Levin and Matthees, Kindlon and Maryhew of scientific misconduct. And at the same time he still claims that 22% of patients with this disease recover due to CBT and GET; Pinocchio Psychiatry at its best. That and More in today's Guardian; article by Peter himself:









"Our research, and that of our colleagues in this field, has attracted its fair share of criticism. Some campaigners have even called for the research to be stopped, the findings retracted, and CBT and GET abandoned completely as they cause harm. One recent focus of criticism has been whether CBT and GET can actually bring about recovery or remission from the illness, not just reduce the symptoms. And by recovery we mean recovery from a patient’s present episode of illness – which is not necessarily the same as being cured, as someone might fall ill again.

To address this we did another test on the data, and found that 22% of people could be considered as recovered with either CBT or GET. Though not a large proportion it was about three times more than the recovery rates achieved by the other two treatments. Other studies showed similar proportions recovering after CBT.

"In the latest step in this saga, a blog  that hasn’t gone through the rigours of scientific peer-review, or being published in a journal claims that CBT and GET are not as effective as we reported. The authors got their figures by tweaks such as increasing the pass-grade for what counted as recovery, and excluding patients who had reported themselves as “much better”."

https://www.theguardian.com/commentisfree/2016/sep/30/me-chronic-fatigue-syndrome-patients-suffer-put-off-treatments-our-research



PS: A review of the PACE trial by Vink, that has gone through the rigours of scientific peer-review, and was published in a Medical journal found that CBT and GET are INEFFECTIVE, aka a NULL effect. You can read the excellent PACE trial review here

  PS 2: I hope that somewhere in the UK there is still a psychologist who hasn't gone to sleep to give PACE trial's Peter White emergency CBT to cure his false Therapy beliefs and turn him into an honest psychiatrist

Tuesday, September 27, 2016

"You can't ignore me now" Naked Millions missing protest at Whitehall to demand better care for M.E patients



By Reya El-Salahi (@_Reya) 27 Sep 2016:
"You can't ignore me now" Naked protestor demands better support for M.E patients. Details on @LondonLive before 2pm #MillionsMissing https://t.co/o9SIbwSO1q (http://twitter.com/_Reya/status/780728125181353984?s=17)

Saturday, September 24, 2016

PACE trial's principal investigator Peter White has retired from clinical practice with immediate effect to avoid ...



PROOF POSITIVE ? (REVISITED)
Margaret Williams, 14th September 2016  

"The role of Professor Peter Denton White OBE
In 2004, Professor Peter Denton White was awarded an OBE for “services to medical education”;
notices circulating at the time proclaimed him as leading the research into “CFS/ME” and said his OBE was “a well-deserved honour and acknowledgement of his contribution to work on CFS/ME”.

He was born in November 1952: aged only 64, he suddenly retired from clinical practice just before he was compelled by an order of the court to release the raw data from the PACE trial, so any
investigation by the General Medical Council for alleged professional misconduct is unlikely to be
pursued, but is he guilty of misfeasance in public office?

According to the Crown Prosecution Service (CPS) website, misfeasance in public office is a cause of
action in the civil court against the holder of public office, the allegation being that the office-holder
has misused or abused their power: such misuse or abuse is an affirmative act that causes harm to
another party without reasonable justification. The NHS is a State body as it provides public health
care, so this matter is one in which the public has a significant interest.

Facts to be considered
1. Peter White has used his own money, as well charitable money and public money, in order to
lobby support for his belief that ME/CFS is a psycho-behavioural disorder that can be
overcome through “cognitive restructuring” and graded aerobic exercise
2. he has egregiously used large sums of public money (£250,000) to prevent the disclosure of
data that would falsify his belief
3. for nearly 30 years, he has ignored evidence that disproves his belief, including evidence from
his own trials
4. he has failed to correct errors of fact after being alerted to them
5. he has consistently failed to disclose significant financial, institutional and ideological
conflicts of interest
6. he has been in breach of his NHS contractual obligations in that he has persistently ignored
mandatory directives and has wilfully encouraged other clinicians to do the same
7. as a consequence of his actions:
 money which should have been used for biomedical research into the aetiology of
ME/CFS has been diverted to fund studies into therapies which were already known
to be ineffective and even harmful
 patients have been stigmatised as sociopaths and malingerers who refuse to accept
they have a behavioural disorder
 patients have been denied financial support from private insurers for whom Peter
White and his colleagues work (for example, he was Chief Medical Officer for the
giant re-insurer Swiss Re and was also CMO to Scottish Provident) and from the" ...

Proof positive (revisited) .pdf

Friday, September 9, 2016

The statement which we should have issued



Statement: Disclosure of PACE trial data under the Freedom of Information Act
http://www.qmul.ac.uk/media/news/items/smd/181216.html


The statement which we should have issued

We sincerely apologize for not releasing the data earlier. We now realise this was a big mistake; even more so as the trial was funded with more than 5 million pounds of public money and therefore the public has a right to see the raw data.
We also sincerely regret ignoring our own NULL effect and making it make it look as if our two favorite treatments ie CBT and GET are moderately effective; it was a major oversight on our side to suggest that 22% of people recovered courtesy of CBT and GET;
We now realise that we have been exposing people with this disease for at least 25 years to ineffective and harmful treatments and that hundreds of thousands of patients have been severely harmed by especially GET;
We also regret decades of ridiculing patients with a debilitating neuro immune disease and pretending it to be a functional disorder, MUS, PPS or words to that effect;
The only function that served was making ourself important so that we could pretend to be experts of this disease and that no one would listen to the patient;
We realize that we cannot make up for all the mistakes we have made over the last 25 years including coming up with the Oxford criteria so that we could select patients who do not have the disease but label them as if they do, in an effort to improve the effectiveness of our treatments;
A very nice side effects of these treatments for this disease was that no doctor will take a disease seriously or ask critical questions if we pretend that it can be cured with behavioral and exercise treatment;
We realize that we have not only let the patients down but also our Universities and our Medical colleagues worldwide; we fully understand that after 25 years of being very economical with the truth and spinning our results people will call us the British Diederik Stapel;
The only way we can make up for our mistakes is by resigning from all our posts with immediate effect and together with our universities and sponsors, we will donate 5 Million £££ ie the equivalent spent on the PACE trial to proper biomedical research as done by the Norwegian oncologists and for example by Stanford's Professor Ronald Davis in an effort to get patients with this debilitating disease effective treatments ASAP;
Our Biopsychosocial model as an explanation for this disease will go down in the history of Medicine and Great Britain as one big ego trip and we sincerely apologize once again for letting patients, our universities and the medical profession down in the biggest possible way;

Sincerely,

The three principal investigators of vested interest psychiatry who have now handed  back their professorships and more

Saturday, September 3, 2016

Psychiatrist Dr. Henderson: proponents of the biopsychosocial model do not want to accept the evidence that ME/CFS is a physical disease and that their model is wrong

Psychiatrist Dr. Henderson: proponents of the biopsychosocial model do not want to accept the evidence that ME/CFS is a physical disease and their model is wrong

Dr. Thomas Henderson - September 2016 @ psychiatryadvisor.com:

  In conclusion, we appear to be entering the type of shake-up in the field that Thomas Kuhn referred to as a “paradigm shift.”7 All of the elements are there.

  A well-established concept about a phenomenon fails to account for a growing number of non-conforming bits of evidence. The examination of the bits of evidence reveals a new theoretical model that better explains the phenomenon. 

  Lastly, the resistance by the established community (in this case the medical community) to give up the old paradigm generates attacks on those who promulgate the new theoretical model, dismissal of the evidence that does not fit the old paradigm, and dogmatic rigidity. Only with great effort is the new paradigm recognized and accepted as correct. We shall see...

 

Monday, August 29, 2016

ME/CFS has an objectively identifiable chemical signature in both men and women 

ME/CFS has an objectively identifiable chemical signature in both men and women 

  By: Robert K. Naviaux a ,b ,c ,d ,1 , * Jane C. Naviaux a ,e , * Kefeng Li a ,b , * A. Taylor Bright a ,b , * William A. Alaynick a ,b , * Lin Wang a ,b , * Asha Baxter f , * Neil Nathan f ,2 , * Wayne Anderson f , and * Eric Gordon

  "Patients with CFS showed abnormalities in 20 metabolic pathways. Eighty percent of the diagnostic metabolites were decreased, consistent with a hypometabolic syndrome."

"We studied a total of 84 subjects using these methods. Forty-five subjects (n = 22 men and 23 women) met diagnostic criteria for ME/CFS by Institute of Medicine, Canadian, and Fukuda criteria. Thirty-nine subjects (n = 18 men and 21 women) were age- and sex-matched normal controls. Males with CFS were 53 (±2.8) y old (mean ± SEM; range, 21–67 y). Females were 52 (±2.5) y old (range, 20–67 y). The Karnofsky performance scores were 62 (±3.2) for males and 54 (±3.3) for females."

Saturday, August 27, 2016

A doctor diagnosed with MUS (a diagnosis used by incompetent doctors) was actually dying from cancer ...



A doctor diagnosed with MUS (Medically Unexplained Symptoms) who was actually dying from cancer ... Highlighting the fact that MUS is a diagnosis of incompetent doctors as evidence that something is MUS or psychosomatic does not exist ...

Dr Lisa Steen: the wilderness of the medically unexplained


This patient perspective essay was written by Lisa Steen. She has since died. We have permission to publish the piece from her husband, Raymond Brown.
I am a GP, formerly a trainee psychiatrist and now 43 years old. In July 2014, I was diagnosed as having kidney cancer with multiple bone metastases. The cancer was extremely rare, associated with a succinate dehydrogenase B (SDHB) mutation. This genetic condition was later also found to be the cause of my carotid body paraganglionoma which had appeared when I was 18 and was finally excised when I was 27.
I had felt unwell in terms of dizziness and visual symptoms since August 2012, and presented to my GP in September 2012, nearly two years before my diagnosis was made in July 2014. So I spent two years wandering in the wilderness of the medically unexplained.
In fact I had been feeling tired for several months even prior to this presentation in August 2012, and had felt like I was lacking concentration. I had been put on a series of antidepressants, each of which caused “side effects” which may have been symptoms of illness all along. Fluoxetine caused headaches, sertraline caused diarrhoea, and dosulepin caused visual disturbance—at least that’s what I thought at the time.
I had considerable difficulty describing my symptoms: primarily visual disturbance; a sense of being behind a wobbly TV camera; also of diplopia—another image slightly below causing blurring, and negative palinopsia, prompting the GP to refer me to the eye clinic urgently, where all examinations were shown to be normal.

There were many other minor symptoms too: fatigue, palpitations, cramps in my hands and feet, subtle cognitive impairments, difficulty finding words, memory problems, difficulty coping at work. I had time off sick even though I previously had an intact sick leave record. I had headaches which were worse on standing, also an altered sensation in a glove and stocking distribution, mild tremor, and gradual weight loss without dieting.
My GP insisted on sending me to a psychiatrist mainly because I had been on so many antidepressants, and we didn’t know which to choose next. But also because I had initially interpreted these symptoms as SSRI withdrawal or dosulepin side effects.
The psychiatrist’s immediate instinct was that the illness seemed “organic” not psychiatric, and neither was it SSRI withdrawal or dosulepin side effects.
A neurologist’s advice was sought and her first thoughts were of hypothyroidism or low calcium. The neurologist also requested an ultrasound of the neck as I had concerns that it was something to do with my previous carotid body tumour, and I wondered if it had returned.
The ultrasound and bloods proved normal. The neurologist did not find anything abnormal on examination apart from a Horner’s syndrome (longstanding and related to the previous carotid body surgery). An MRI of my head was subsequently normal.
The psychiatrist made a diagnosis of depression and health anxiety, but without much psychiatric evidence, I felt. This diagnosis not only perplexed me, and I wandered away from my own further diagnostic enquiry, but it impacted on consultations following this diagnosis.
I did not entirely believe my psychiatrist however, mainly because the visual symptoms were so florid. I considered myself very psychologically aware and was not convinced about the anxiety/depression diagnosis. Though, unfortunately I had proved a highly suggestible subject during the cognitive behavioural assessment, due to having been trained in CBT myself.

The symptoms did indeed get worse with stressful situations, but this was partly because those situations occurred whilst standing—such as presenting patients on the morning ward round. This had been a factor in stopping work, because there were problems with my word finding and memory. On reaching the patient’s bedside I found myself almost hallucinating in terms of palinopsia, purple haze and blotches, all of which was very distracting whilst trying to contribute to the ward round. It was impossible really to continue working without working life becoming a total humiliation. This did indeed lead to low self worth and anxiety. The low level acute confusional state, as I now see it, meant that I was functioning at a suboptimal level at work, for no clear reason, this then led naturally to anxiety and concern. It was then difficult for me to untangle my own symptoms from psychiatric ones.
Since I was being paid to be off sick, I felt it my duty to follow orders. So therefore to pursue psychological cure—though at the same time I was reading about the physical causes of my symptoms.
I spent the next few months trying to address my apparent mental health problems with a psychologist, and I mainly considered myself to have a psychosomatic illness maybe some sort of conversion disorder. Unusually, I worked backwards, as it were, to exclude a psychiatric illness so as to realise I had a medical illness.
But I gradually became convinced that exertion and not anxiety caused the visual symptoms to worsen, I also thought that the nature of the symptoms “felt” organic because of the pronounced and ongoing visual symptoms.
I then started to look for threads, clues, and a way forward to get treatment. This was thwarted by my earlier diagnosis of health anxiety and having medically unexplained symptoms. One could not be dogmatic in further requests for investigations for fear of looking even more “anxious” or suffering from “health anxiety,” aka a hypochondriac. I wanted to ask the GP for a chest x-ray and abdominal ultrasound, and thought about paraneoplastic syndromes but I always tended to think it was not cancer, in view of the normal inflammatory markers and the length of time it had gone on. But I suspect also it was a pitfall of being forced into the “physician heal thyself” situation.
I saw a vascular surgeon, privately, wondering if the carotid was narrowed by scar tissue from the previous surgery, thinking maybe inadequate blood supply to the brain/retina could be occurring—which is the cause of physiological palinopsia. The carotid was not narrowed, but the vascular surgeon who performed the duplex ultrasound suggested that I might have a genetic disorder and have a phaeochromocytoma, which was something that impacted on his field. I persuaded my GP to order a 24 hour metanephrine test which frustratingly came back negative. At my behest the heart-sunk GP also did blood tests for SLE, and infectious serology screen.
In Spring 2013, I presented to Poole A&E in Dorset with palpitations, whilst on holiday (the palpitations unhelpfully disappeared on arrival in A&E). The heart rhythm was normal, but the A&E doctor was convinced she heard a third heart sound, and suggested a follow up.
So the next relevant thing seemed to be referral to a cardiologist, in June 2013. I suggested to the cardiologist the possibility of a genetic syndrome related to carotid body tumours. The cardiologist was a kindly man, but after exclusion of any cardiac conditions with an echo and 24 hour tape he began to consider the initial health anxiety diagnosis—or at least it looked like that to me. Once again a kind of consulting room glazing occurred and I was left once more looking like a goldfish. My mouth moving but no sound conveyed to the doctor’s ears. This was by now a familiar feeling to me.
The cardiologist did at least acquiesce to my suggestion that I may have POTS syndrome: postural orthostatic hypotension and suggested referral to a specialist. So I could have some excuse for being off sick.
By now I had gone back to work. There had been a rotation, and I was assigned to a consultant psychiatrist, who made it her mission to rehabilitate me back to work.
By August 2013, I hoped that I had found a thread, something tangible that the specialist could investigate secondary causes of. The POTS specialist did at least do a full examination, though he was not worried about my concerns of a possible pulsatile mass on the left flank, and thought my aorta was just rather left of centre. A tilt table test was organised which was “borderline positive.” In February 2014 further urinary and blood metanephrines were normal. All bloods were repeated and normal. The ESR and CRP remained very low.
At this point I gave up my quest: I was back at work, part time with a benevolent boss, and coping, though tired. I had adapted to my visual disturbance and could now function with it, though I was still embarrassed by my word finding difficulties. I tried to be more organised, and write everything down.
I still knew there was something wrong, but it seemed so fruitless going to see specialists. It was so humiliating, feeling like a goldfish with no voice. Watching doctors’ faces glaze over at the multitude of symptoms. Trying to fit it all in with work and looking after my family.
I decided it would have to wait for clinical events to become more diagnosable. I had tried as hard as I felt reasonably possible. It is also taboo to discuss one’s own health in any depth at work, and I was so exasperated by it all that I felt I would cry if anyone were too sympathetic—which doctors might then interpret as a psychiatric symptom.
In February 2014 I had a follow up with an occupational health doctor. This time the occupational health doctor became concerned, and noticed that I had lost weight and suggested seeing a bowel specialist in relation to a change in bowel habit and to see a neurologist about my numb hands and feet.
I went home and gave myself a full examination. This time I was sure. I found a large mass in my left flank.
I saw my GP, but they couldn’t feel it. I saw my POTS specialist a couple of weeks later and he thought it might be an enlarged spleen. He ordered a routine ultrasound.
One evening in June 2014 the junior radiology technician, working on a waiting list initiative, found a solid/cystic mass 10cm in diameter arising from the left kidney.
I was initially jubilant thinking this would turn out to be a phaeochromocytoma—maybe dopamine secreting. And now I could have an “anxietyectomy.” An urgent CT of the abdomen and pelvis was recommended.
The result was not cause for celebration. The CT showed that the mass was arising from the left kidney and was reported as looking like a renal cell carcinoma. There were also multiple sclerotic lesions in the spine, ribs, and pelvis reported as metastases.
By then I had abandoned my psychiatric training. I had felt unable to study because of “brain fog,” however I had managed to get over the many hurdles to get back my GP status, which involved three exams and six months of retraining.
I had just landed a job as GP Lead for Inclusion service, treating patients with drug and alcohol problems. But the news came just a few days after my interview and offer of the post. My progression through medical services was much more efficient after that and I saw an oncologist and the urologist urgently.
***
I do not know how long I’ll live. It probably won’t be for many weeks. But right now I am glad to be alive, I am grateful for the expensive drug which is holding back the cancer. I am angry at being left in the medically unexplained wilderness and I did not like the way my colleagues looked at me, when they believed me to have health anxiety.
If anyone of the doctors I saw had gone another mile they would’ve stumbled upon it. I almost told them the answer; I repeated over and over my belief of a genetic syndrome linked to the carotid body, something related to it, but they were unable to hear the answer from a patient. They were reluctant to lay their hands on and examine a fellow medic. I was disappointed in finding a very poor appetite for a diagnostic hunt, which may in part be the result of protocolisation and superspecialism. I disliked being unable to order my own tests, and I regret not pulling more strings. I was too embarrassed about my “psychiatric” condition, too confused by not having the whole answer ready.
My story is a cautionary tale to all of us health professionals when we get ill. Illness is somehow not the done thing. It upsets our “them/us” belief system, which helps us cope with the horror of what we see. “We do not get ill, they are ill.” We are a lot more military than we realise.
We are trained to keep going, as if there was a war on. Our workloads are superhuman, and we seriously do not appreciate it if those around us “slack off,” particularly those taking sick leave with depression or stress. “Heaven knows the rest of us are depressed and stressed, all right for some putting their feet up.”
I felt deeply ashamed of being too unwell to work.
The communication was different, it didn’t go the same way that it would have if I was a non-medic. Doctors do not like being told what to do, and if you try obliquely they don’t notice. They don’t worry much as they assume you’ll come back. But it is hard getting to appointments when one is working, and just how many times can you come back if it gets worse? I was beginning to think that our etiquette for being seriously ill is to drop dead on the job—it is fairly common practice, anecdotally anyway.
Mine is a cautionary tale to those treating health professionals, and those of us who are unwell—doctors do get ill, they don’t always know what is wrong with themselves: give them a class A service because it is actually harder getting treated as a doctor than a lay person.

Friday, August 26, 2016

Please Sign this PETITION: ME is not MUPS or SOLK (PACE trial proved ME/CFS is physical)



PACE trial proves ME/CFS is physical; it's not MUPS (Medically Unexplained Physical Symptoms) or SOLK  

A quick history:

56000 signatures were collected by very ill patients several years ago (Dutch Patient/Citizen Initiative Recognize ME) to get Parliament to listen. They asked Dutch Health council to write a new advisory report about state of the knowledge about ME. However serious conflicts of interest of the members of the Dutch Health Council (ie Dutch PACE colleagues) are ignored.

There are members on there who think along the lines of the Wessely school of vested interest psychiatry, ie the biopsychosocial model, a hypothesis disproven by 1000s of research articles and by Wessely's PACE trial itself !!

ME is a chronic complex multi-system disease, anyone who claims otherwise has no place in health care. Health care and treatment can no longer be based on people clinging to old paradigms, based on non-evidence based treatments. Lets Raise our voice together as this problem affects ME patients around the world.

Please SIGN this petition @  petities.nl

  Thank you for considering and / or signing !

Please remember the outcome of the INDEPENDENT review of the PACE trial, which amongst things showed that the real conclusions of this trial, based on the published results, contrary to the published conclusions, are that: 1. CBT and GET are ineffective to treat people with ME (also known as CFS or ME/CFS) also called a NULL effect; 2. A discovery by the trial which proves yet again that ME/CFS is a physical disease; 3. The disproval of the biopsychosocial model favored by the British (PACE trial) psychiatrists and their Dutch Nijmegen friends.

The full article "The PACE Trial Invalidates the Use of Cognitive Behavioral and Graded Exercise Therapy in Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome: A Review" with it's other conclusions can be read here, free of charge.

 

Tuesday, August 23, 2016

In Argentina, Ampligen has just been commercially approved for severe ME/CFS



PHILADELPHIA, Aug. 23, 2016 (GLOBE NEWSWIRE)

  "“In Argentina, rintatolimod (Ampligen) has just been commercially approved for the severe disabling form of ME/CFS.  The number of patients with ME/CFS is estimated to be over three million worldwide, however, only a portion of these have the severe and disabling form of the disease which we are targeting with this drug,” stated Tom Equels."

  "Several post-approval activities are required to be completed before product launch, including manufacturing site inspections and reimbursement evaluation by the Health Services Authority (SSS), the central health authority in Argentina."

 

Thursday, August 18, 2016

OMG: Prof Chalder admits that they made up the death threats themself to ridicule patients



Prof Chalder admits that they made up the death threats to ridicule patients in trying to make sure that the PACEtrial data doesn't get released. Therefore it doesn't take a genius to conclude that the data is much worse than what they have presented and published because if it would have backed up their claims they would have long shared it ...

P 36 @ informationtribunal.gov.uk

Wednesday, August 17, 2016

Prof Chalder: Cochrane review not independent at all as all principal investigators of the PACE trial sat on it ...


P31:
"Professor Chalder states that disclosure to the Cochrane review does not count as disclosure to independent scientists as all three of the PACE principal investigators sat on the review panel."

 Which means that the principal investigators of the PACE trial were reviewing their own trial ...

So it is becoming clearer and clearer that the PACE trial is a bridge too far for the psychiatrists who have been lying about a debilitating neuro immune disease for decades.

More @ informationtribunal.gov.uk

Tuesday, August 9, 2016

That moment you realize there is an overlap in entry and recovery criteria in the 8 million dollars costing thing of beauty




The real thing of beauty is the review of the PACE trial, which amongst things showed that the real outcome of this trial, contrary to the published conclusions, is that:

1. CBT and GET are ineffective to treat people with ME (also known as CFS or ME/CFS) also called a NULL effect
2. A discovery by the trial which proves yet again that ME/CFS is a physical disease
3. The disproval of the biopsychosocial model favored by the British (PACE trial) psychiatrists

The full article "The PACE Trial Invalidates the Use of Cognitive Behavioral and Graded Exercise Therapy in Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome: A Review" is available free of charge.

Sunday, July 31, 2016

Spinal fluid abnormalities in patients with ME/CFS

Spinal fluid abnormalities in patients with chronic fatigue syndrome

  @ PubMed:

  Natelson BH 1, Weaver SA , Tseng CL , Ottenweller JE . Spinal fluid abnormalities in patients with chronic fatigue syndrome. Clin Diagn Lab Immunol.  2005 Jan;12(1):52-5.

  Abstract

  Arguments exist as to the cause of chronic fatigue syndrome (CFS). Some think that it is an example of symptom amplification indicative of functional or psychogenic illness, while our group thinks that some CFS patients may have brain dysfunction. To further pursue our encephalopathy hypothesis, we did spinal taps on 31 women and 13 men fulfilling the 1994 case definition for CFS and on 8 women and 5 men serving as healthy controls.

  Our outcome measures were white blood cell count, protein concentration in spinal fluid, and cytokines detectable in spinal fluid. We found that significantly more CFS patients had elevations in either protein levels or number of cells than healthy controls (30 versus 0%), and 13 CFS patients had protein levels and cell numbers that were higher than laboratory norms; patients with abnormal fluid had a lower rate of having comorbid depression than those with normal fluid.

  In addition, of the 11 cytokines detectable in spinal fluid, (i) levels of granulocyte-macrophage colony-stimulating factor were lower in patients than controls, (ii) levels of interleukin-8 (IL-8) were higher in patients with sudden, influenza-like onset than in patients with gradual onset or in controls, and (iii) IL-10 levels were higher in the patients with abnormal spinal fluids than in those with normal fluid or controls.

  The results support two hypotheses: that some CFS patients have a neurological abnormality that may contribute to the clinical picture of the illness and that immune dysregulation within the central nervous system may be involved in this process.

Tuesday, July 19, 2016

Neuromuscular Strain causes symptom flare-ups in ME/CFS

RESEARCH ARTICLE

Neuromuscular Strain Increases Symptom Intensity in Chronic Fatigue Syndrome

Peter C. Rowe , Kevin R. Fontaine , Megan Lauver , Samantha E. Jasion , Colleen L. Marden , Malini Moni , Carol B. Thompson ,Richard L. Violand

 * Abstract* Chronic fatigue syndrome (CFS) is a complex, multisystem disorder that can be disabling. CFS symptoms can be provoked by increased physical or cognitive activity, and by orthostatic stress. In preliminary work, we noted that CFS symptoms also could be provoked by application of longitudinal neural and soft tissue strain to the limbs and spine of affected individuals. In this study we measured the responses to a straight leg raise neuromuscular strain maneuver in individuals with CFS and healthy controls. We randomly assigned 60 individuals with CFS and 20 healthy controls to either a 15 minute period of passive supine straight leg raise (true neuromuscular strain) or a sham straight leg raise. The primary outcome measure was the symptom intensity difference between the scores during and 24 hours after the study maneuver compared to baseline. Fatigue, body pain, lightheadedness, concentration difficulties, and headache scores were measured individually on a 0–10 scale, and summed to create a composite symptom score. Compared to individuals with CFS in the sham strain group, those with CFS in the true strain group reported significantly increased body pain (P = 0.04) and concentration difficulties (P = 0.02) as well as increased composite symptom scores (all P = 0.03) during the maneuver. After 24 hours, the symptom intensity differences were significantly greater for the CFS true strain group for the individual symptom of lightheadedness (P = 0.001) and for the composite symptom score (P = 0.005). During and 24 hours after the exposure to the true strain maneuver, those with CFS had significantly higher individual and composite symptom intensity changes compared to the healthy controls.

We conclude that a longitudinal strain applied to the nerves and soft tissues of the lower limb is capable of increasing symptom intensity in individuals with CFS for up to 24 hours.

These findings support our preliminary observations that increased mechanical sensitivity may be a contributor to the provocation of symptoms in this disorder.

Citation: Rowe PC, Fontaine KR, Lauver M, Jasion SE, Marden CL, Moni M, et al. (2016) Neuromuscular Strain Increases Symptom Intensity in Chronic Fatigue Syndrome. PLoS ONE 11(7): e0159386. doi:10.1371/journal.pone.0159386

Editor: Ute Vollmer-Conna, University of New South Wales, AUSTRALIA

Received: March 17, 2016; Accepted: July 3, 2016; Published: July 18, 2016

More @ Plosone

 

Saturday, June 25, 2016

Professor Hanson: further evidence against the ridiculous concept that ME/CFS is psychological


Professor Maureen Hanson: "our detection of a biological abnormality provides further evidence against the ridiculous concept that the disease is psychological in origin"

By Krishna Ramanujan, June 24, 2016, Cornell University:

  ksr32@cornell.edu

  Indicator of chronic fatigue syndrome found in gut bacteria

  In a study published June 23 in the journal Microbiome, the team describes how they correctly diagnosed myalgic encephalomyeletis/chronic fatigue syndrome (ME/CFS) in 83 percent of patients through stool samples and blood work, offering a noninvasive diagnosis and a step toward understanding the cause of the disease.

  “Our work demonstrates that the gut bacterial microbiome in ME/CFS patients isn’t normal, perhaps leading to gastrointestinal and inflammatory symptoms in victims of the disease,” said Maureen Hanson, the Liberty Hyde Bailey Professor in the Department of Molecular Biology and Genetics and the paper’s senior author.

  “Furthermore, our detection of a biological abnormality provides further evidence against the ridiculous concept that the disease is psychological in origin,”

  More @ cornell.edu

Friday, June 3, 2016

Ester Crawley given a million pounds to replicate FITNET's NULL effect


Ester Crawley given a million pounds to replicate FITNET's NULL effect

http://www.nets.nihr.ac.uk/projects/hta/14192109

Ester Crawley's Study will be based on the following Dutch study also called FITNET which ignored their own NULL effect just like the PACE trial did.




Because it's obviously more important to make sure that people who are severely ill do not get proper treatment and to make sure that their kingdom which is based on fake tan doesn't come tumbling down. The Sad State of Affair of greed and denial medicine ...

  Nijhof SL, Priesterbach LP, Uiterwaal CS, Bleijenberg G, Kimpen JL, van de Putte EM, Internet-based therapy for adolescents with chronic fatigue syndrome: long-term follow-up. Pediatrics. 2013 Jun;131(6):e1788-95. doi: 10.1542/peds.2012-2007. Epub 2013 May 13.

  ( Bleijenberg G aka the Dutch Peter D White or Simon Wessely and van de Putte EM aka the Dutch Ester Crawley)

  "Cognitive behavioral therapy (CBT) is known to be an effective treatment of adolescents with chronic fatigue syndrome (CFS), but its availability is limited." No it's not known to be effective but they want us to believe it is effective which is a totally different thing ... The reality is, as a recent review of the PACE trial showed, that CBT and GET are totally useless !!! But the BIG LIE must obviously continue ...

  "Fatigue in Teenagers on the Internet (FITNET), an Internet-based CBT program for adolescents with CFS, has been developed as an alternative to face-to-face CBT. Recently, its short-term effectiveness has been proven in a randomized clinical trial. Here we aimed to assess the long-term outcome of CFS in adolescents after FITNET treatment and after usual care."

  "Conclusion: The short-term effectiveness of Internet-based CBT on adolescent CFS is maintained at LTFU. At LTFU, usual care led to similar recovery rates, although these rates were achieved at a slower pace."

  "At LTFU, usual care led to similar recovery rates" aka as a NULL effect ...

  http://www.ncbi.nlm.nih.gov/pubmed/23669515

 

Tuesday, May 17, 2016

Unexpressed feelings towards lying psychiatrists? Then here is the reason why ...

Unexpressed feelings towards lying psychiatrists? Then here is the reason why ... If you have some unexpressed feelings towards lying psychiatrists like Simon Peasley, Pizza White, Michael Blushing and Trudies Itchyshoulder then here you can read why you have them ... Please make sure you have got a bucket ready otherwise you will need some urgent CeeBeeTea If you are really desperate then here is the link to the study http://psycnet.apa.org/psycinfo/2016-23898-001/

Wednesday, April 20, 2016

Great letter by Professor Hooper asking for retraction of the PACE trial 

Great letter by Professor Hooper asking for retraction of the PACE trial via meactionuk.org.uk, April 15, 2016:

  Dear Dr Horton,

  I write to call again for the retraction of the PACE study paper by White PD et al. (Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. "Lancet "2011;377:823-836).

  MORE @ meactionuk.org.uk

 

Friday, April 8, 2016

Published, independent review of the PACE trial‏

The PACE Trial Invalidates the Use of Cognitive Behavioral and Graded Exercise Therapy in Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome: A Review


Corresponding author: Vink, Family Physician, Soerabaja Research Center, Amsterdam, The Netherlands
E-mail: markvink.md@outlook.com

Abstract
The main findings reported in the PACE trial were that cognitive behavioral therapy (CBT) and graded exercise therapy (GET) were moderately effective treatments for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), and fear avoidance beliefs constituted the strongest mediator of both therapies. These findings have been challenged by patients and, more recently, a number of top scientists, after public health expert Tuller, highlighted methodological problems in the trial. As a doctor who has been bedridden with severe ME for a long period, I analyzed the PACE trial and its follow-up articles from the perspectives of a doctor and a patient. During the PACE trial the eligibility criteria, both subjective primary outcomes, and most of the recovery criteria were altered, creating an overlap of the eligibility and recovery criteria; consequently, 13% of patients were considered “recovered,” with respect to 1 or 2 primary outcomes, as soon as they entered the trial. In addition, 46% of patients reported an increase in ME/CFS symptoms, 31% reported musculoskeletal and 19% reported neurological adverse events. Therefore the proportion negatively affected by CBT and GET would be between 46% and 96%, most likely estimated at 74%, as shown in a large survey recently conducted by the ME Association. Medication with such high rates of adverse events would be withdrawn with immediate effect. There was no difference in long-term outcomes between adaptive pacing therapy, CBT, GET and specialist medical care, and none of them were effective, invalidating the biopsychosocial model and use of CBT and GET for ME/CFS. The discovery that an increase in exercise tolerance did not lead to an increase in fitness means that an underlying physical problem prevented this; validates that ME/CFS is a physical disease and that none of the treatments studied addressed this issue.

FULL article in Journal of Neurology and Neurobiology

Tuesday, March 29, 2016

RIP Mr Cicero; German jazz singer Roger Cicero has died after being diagnosed with ME/CFS #PACEtrial #NOmorePsychiatricLIES


RIP Mr Cicero; German jazz singer Roger Cicero has died after being diagnosed with #MEcfs #PACEtrial #NOmorePsychiatricLIES

  dw.com, Mar 29, 2016:

  Germany's best-known jazz performer has died after being diagnosed with chronic fatigue syndrome. His career spanned almost 15 years, making him one of Germany's most beloved musical celebrities.

Friday, March 25, 2016

Thursday, March 24, 2016

#PACEtrial Psychiatry is much worse than #DiederikStapel psychology: Two great articles about the seriously flawed PACE trial

Two great articles about the seriously flawed PACE trial

  Editorial: On PACE by Trevor Butterworth, Mar 21, 2016: "And the thing about patients who either suffer from a rare disease, or a more common and inexplicable one as with ME/CFS, is that they are usually a formidable resource—a network of distributed experts who have sifted and weighed the scientific research with the kind of avidity you would expect, given that their lives depended on it. In pharmacology, rare disease patient groups are highly respected and are seen as partners in research rather than just subjects and consumers of studies."

  MORE @ stats.org

  AND

  PACE: The research that sparked a patient rebellion and challenged medicine by Professor Rebecca Goldin, Mar 21, 2016 :

  "The results from PACE (including these) have been published in prestigious journals and influenced public health recommendations around the world; and yet, unraveling this design and the characterization of the outcomes of the trial has left many people, including me, unsure this study has any scientific merit. How did the study go unchallenged for five years? And how could journalists have recognized the problems before reporting unqualified, but unjustified, good news?"

  MORE @ stats.org

Tuesday, February 16, 2016

Nice explanation of PACE trial nonsense and Wessely psychiatry

Nice explanation of PACEtrial nonsense and Wessely psychiatry by @dwbarlow: "If the only tool you have is a hammer you tend to see every problem as a nail"

Saturday, February 13, 2016

Dr Esther Crawley acknowledges in the MAGENTA protocol that ME/CFS patients will not benefit from graded exercise therapy


The MAGENTA trial aka the PACEtrial for children involves "Children between 8 and 17 years old who have been diagnosed with CFS/ME." So they will be experimenting and using their unethical and harmful treatment on 8 year olds ...

"The aim of this study is to find out how successful and cost-effective GET is ... in children" with ME/CFS.
We do know that subjective outcomes are not reliable so what does the magenta trial use?  "The children and their parents are then interviewed in order to judge how well the treatment is working." So no objective measures are used as usual ... However the principal investigator of this trial also writes that "What are the possible benefits and risks of participating? Participants will not benefit directly from taking part in the study" which means that children with ME/CFS who are getting treated with GET will not benefit from it ... Why waste a million £££ on it if she already knows that the treatment doesn't work ?? If you don't know the answer to that question just read on or scroll down ...

Furthermore GET causes severe relapses if patients do have ME/CFS unless the diagnosis is wrong or people are in remission which happens in 5 to 7% but even they have to be careful with exercise therapy. So if you subject people with ME/CFS to exercise therapy you are basically torturing patients. Yet what do they write in the protocol? "it may prove enjoyable contributing to the research. There are no risks of participating in the study."
So if you acknowledge that the treatment doesn't work like the principal investigator Dr Esther Crawley is doing in the protocol then you are basically wasting shedloads of money to make sure that people with this debilitating neuroimmune disease do not get proper treatment; shameful doctoring as usual from the denial Brigade who have been ignoring evidence for decades. And according to medical boards doctors should not ignore evidence which goes against the duties of a doctor ... Which means that the denial Brigade should be suspended or struck off ...
You can read the delightful protocol here: http://www.isrctn.com/ISRCTN23962803

Thursday, February 11, 2016

"I’m tired of having to counter the same propaganda ad nauseum."

"I’m exhausted by the politics and the endless endless lies and spin. I’m tired of having to counter the same propaganda ad nauseum." YES that sounds like the denial psychiatrists Simon Wessely, Peter White, Michael Sharpe, Trudie Chalder and their PACEtrial propaganda but as a matter of fact it's from the juniordoctorblog explaining why they strike.

Just posted this on Action for ME Facebook site to get behind the PACE trial data sharing

Well guys it's pretty simple you take a big black marker and you anonimise the data; when patients signed the consent form to take part in the trial they consented for the data to be released in an anonymous way to independent researchers etc; if however some patients change their mind you just exclude their data from release. It's that simple. And as you probably know patients can withdraw their consent at anytime. It's time that you as Action for ME take a stand against the BAD PACE trial "science" which is hurting hundreds of thousand people worldwide.

Wednesday, February 10, 2016

The sickening hypocrisy of the PACE trial and it's Researchers


Feb 5th, 2016

Why the PACE researchers and their institutions affectation of concern for participants is particularly sickening hypocrisy


In 1990 Sir Iain Chalmers wrote in the Journal of the American Medical Association, “Failure to publish an adequate account of a well-designed clinical trial is a form of scientific misconduct that can lead those caring for patients to make inappropriate treatment decisions.”
(Iain Chalmers. JAMA. 1990 Mar 9;263(10): 1405-8.doi:10.1001/jama.1990.03440100121018)

It could be argued that any Clinical Trial which omits to publish the Primary Outcome Measures as declared and approved in the Protocol ‘is a form of scientific misconduct’; especially if tampering with the outcome measures skews the data and the skewed data is then spun in the media to further exaggerate the findings.

The Declaration of Helsinki states: “36. Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research.Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports.”

The World Health Organization (2004), A Practical Guide for Health Researchers states: “Writing the research protocol
“… once a protocol for the study has been developed and approved, and the study has started and progressed, it should be adhered to strictly and should not be changed. This is particularly important in multi-centre studies. Violations of the protocol can discredit the whole study…”
(http://whqlibdoc.who.int/emro/2004/9290213639.pdf)

The Research Councils UK Policy and Code of Conduct on the Governance of Good Research Conduct states:
“All research should be conducted to the highest levels of integrity, including appropriate research design and frameworks, to ensure that findings are robust and defensible. [] This code therefore concentrates on entirely unacceptable types of research conduct. Individuals involved in research must not commit any of the acts of
research misconduct specified in this code.”
Falsification
This includes the inappropriate manipulation and/or selection of data, imagery and/or consents.”
Misrepresentation, including: misrepresentation of data, for example suppression of relevant findings and/or data, or knowingly, recklessly or by gross negligence, presenting a flawed interpretation of data;”
(http://www.rcuk.ac.uk/documents/reviews/grc/goodresearchconductcode.pdf)

The Medical Research Council (MRC) Guidelines for Good Clinical Practice in Clinical Trials states: “2.5 Clinical trials should be scientifically sound and described in a clear detailed protocol.
2.6 A trial should be conducted in compliance with the protocol that has received prior Ethical Committee favourable opinion.”
(https://www.mrc.ac.uk/documents/pdf/good-clinical-practice-in-clinical-trials/)

Ben Goldacre remarked in The Guardian, “…in a trial, you might measure many things but you have to say which is the “primary outcome” before you start: you can’t change your mind about what you’re counting as your main outcome after you’ve finished and the results are in. It’s not just dodgy, it also messes with the statistics.”  Goldacre added, “You cannot change the rules after the game has started. You cannot even be seen to do that.”
(Ben Goldacre. Clinical trials and playing by the rules.  The Guardian, Saturday January 5, 2008)

Most of the £5 million that the PACE Trial has cost, came from public money allocated through the Medical Research Council (MRC); whose Guidelines for Good Research Practice (2005) state: “The MRC’s mission can only be fulfilled if the results of research are communicated effectively. The MRC therefore expects those it supports to play their part in disseminating balanced information on scientific advances and their potential implications for society to the health professionals and policy makers who will be involved in applying them, and to the wider public.”

Now let us see what our fine British Institutions say about the PACE Trial, starting with the MRC themselves.  The very institution which handed over millions of pounds of our money. Their website states:

“In 2011, the first findings from the PACE trial showed that CBT and GET benefit around 60 per cent of patients with CFS/ME”
(http://www.mrc.ac.uk/news/browse/two-effective-treatments-for-cfsme-are-also-cost-effective/)

Then there are Queen Mary University of London and Kings College London who both declare on their websites:
(http://www.qmul.ac.uk/media/news/items/smd/44140.html)
(http://www.kcl.ac.uk/newsevents/news/newsrecords/2011/02Feb/SafeandeffectivetreatmentsforCFSME.aspx)

“Two effective treatments benefit up to 60 per cent of patients with Chronic Fatigue Syndrome or Myalgic Encephalomyelitis”

The 60% figure claimed by these institutions is false.  Furthermore, the claim is in breach of the Declaration of Helsinki and every credible research guideline, including the MRC’s own.

This 60% figure is not just false information about ideas or about objects; it is false information about research participants.  It is not just disrespectful, it is an attack on their person and their autonomy.

Anyone with sincere concern for the welfare of PACE Trial participants, who was in a position to do so, would take steps to correct this false representation of participants as a matter of urgency.

The true figure for participants having a treatment affect in the PACE Trial is 15%.

The 15% figure can be calculated from the data published in the Lancet.  15% is even supported in a statement made by Professor Michael Sharpe*: “We have a number needed to treat; I think it's about seven to get a clinically important treatment benefit with CBT and GET.”  A ‘number needed to treat’ (NNT) of 7, correlates with only 15% of treated patients getting any benefit.
The whole point of doing a Controlled Clinical Trial is the ‘Control Group’.  Their results are subtracted from the treatment arms to give the true treatment effect.  15% is somewhat less than the 60% that is claimed by the MRC, KCL, QMUL; and reports in national and international media who were fed their information by the PACE Trial researchers and the Science Media Centre.
(*http://www.abc.net.au/radionational/programs/healthreport/comparison-of-treatments-for-chronic-fatigue/2993296)

The General Medical Council state in their Good Practice in Research Guide:
·      You must help to resolve uncertainties about the effects of treatments. (Paragraph 14f)
·      Research involving people directly or indirectly is vital in improving care and reducing uncertainty for patients now and in the future, and improving the health of the population as a whole. (Paragraph 70)
·      If you are involved in designing, organising or carrying out research, you must put the protection of participants’ interests first, act with honesty and integrity and follow the appropriate national research governance guidelines. (Paragraph 71)”

When researchers misrepresent data from trial participants, it exploits the trust and generosity of the volunteers and may involve them, most likely against their will and without their knowledge, in misleading other patients, the public and the medico-scientific communities.

Participants are entitled the protection of the Declaration of Helsinki.  Tampering with their data and misrepresenting it breaches their right to autonomy and nullifies Informed Consent.  For example, a PACE Trial participant whose outcome SF36PF score was 60 and Chalder Fatigue Scale score was 18 would evidently be suffering significant illness and restrictions.  How would they feel about researchers claiming that according to their new-fangled criteria, the participant’s health was ‘normal range’?  Did they consent to this?

An SF36PF score of 65 was considered bad enough to JOIN the PACE Trial – so participants could get 5 points WORSE but then be called ‘Normal Range’.  How is that showing respect to participants?

How might this misrepresentation impact on participant’s medical treatment or entitlement to state benefits?  What impact could it have on their trust of medical professionals and researchers?  How might it impact on their moral and social and religious values – that they have been used, exploited in a way that could harm the health and interests of their fellow patients and their families?

PACE Researchers and their institutions affect concern for participants as a ploy to refuse sharing the PACE Trial data; even though for 5 years they have misrepresented those same participant’s data.  It is a particularly sickening hypocrisy.

Peter Kemp MA

https://docs.google.com/document/d/1x5w52E63CZ2OrQ5c0x1rC3jm_dhw_5mi0sONeaWqmvU/edit

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