Trial by Error: My E-Mail Exchange With NICE Chief Executive

By David Tuller, DrPH

On Friday, I had an e-mail exchange with Sir Andrew Dillon, chief executive of the NICE Guidance Executive. The other seven Guidance Executive members are various directors within the NICE hierarchy, including the communications director. This group will make the final decision about whether to accept the provisional decision of a NICE surveillance review team to leave as is CG53, the guidance for CFS/ME released in 2007. (I have written about the NICE review process on CG53 here, here and here.)

That ten-year-old CFS/ME guidance recommends treatment with graded exercise therapy and cognitive behavior therapy. NICE reaffirmed the guidance after the 2011 publication of the first PACE results, which were taken as evidence that these treatments were effective. As part of the current review process, NICE provided stakeholders with a two-week window last month to submit comments about the provisional decision not to change CG53. Not surprisingly, this recommendation has alarmed many patients and advocates.

I didn’t expect to get answers to my questions from the Guidance Executive, but I felt an obligation to pose them anyway, given the importance of the issues. In fact, Sir Andrew responded to my e-mail within an hour. He explained that no comments would be forthcoming while the Guidance Executive was reviewing the situation. I have posted his response below my initial e-mail.

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Sir Andrew Dillon
Chief Executive
National Institute for Health and Care Excellence
 
Dear Sir Andrew:
 
I am a journalist and public health researcher at the University of California, Berkeley. I have reported on the current review of CG53, the NICE guidance for CFS/ME, for the science site Virology Blog, which is hosted by Professor Vincent Racaniello, a microbiologist at Columbia University. I have previously reported for Virology Blog on the PACE trial and other issues related to graded exercise therapy and cognitive behavior therapy. Earlier this year, I co-authored a commentary about the serious problems with PACE for the Sunday opinion section of The New York Times. 
 
In my role as a journalist covering this issue, I have some questions for you and the other members of the NICE Guidance Executive about the decision-making process concerning the provisional recommendation to make no changes to CG53: 
 
1) For many years, the U.S. Centers for Disease Control recommended GET and CBT as treatments, citing PACE. In late June or early July, the agency removed all references to these therapies from its main pages on the illness. Does the Guidance Executive plan to consult with American public health officials about what prompted this major “dis-endorsement” of these two therapies that NICE continues to promote? 

2) In 2015, both the U.S. National Institutes of Health and the Institute of Medicine (now the National Academy of Medicine) released reports on the illness (they call it ME/CFS). These reports both concluded that it is a serious organic disease involving pathophysiological processes and not a psychological or psychiatric disorder—a determination that would have significant impact on treatment options. Does the Guidance Executive plan to consider these two reports and consult with any of the members of the panels that wrote them?
  
3) Other fields of medicine have abandoned the use of the trial design favored in this entire body of research, including PACE: open-label studies with subjective outcomes. That’s because other fields of medicine recognize that the combination of those two features in one study inherently produces bias. Does the Guidance Executive share these concerns about results from open-label studies with subjective outcomes, or does it believe that such studies can produce reliable and unbiased evidence suitable for clinical decision-making?  
 
4) In PACE and other studies from this field, objective measures have largely failed to support the subjective results that have generated claims of “recovery” or significant clinical improvement. Does this pattern of sharp contradiction between objective and subjective results raise questions for the Guidance Executive about whether patients are objectively getting better?
 
5) In the 2011 Lancet paper, 13 % of the PACE participants had already met one of the study’s outcome thresholds at trial entry—that is, although assessed as “disabled” enough in physical function to qualify for the study, they were also found to be “within normal range” for physical function, before any treatment at all. In the 2013 Psychological Medicine paper, the same 13 % were already “recovered” for physical function at baseline, before any treatment at all—that is, they were simultaneously “disabled” for physical function and “recovered” for physical function. These facts were not included in the published papers but emerged later through a patient’s freedom-of-information request. Does the Guidance Executive have confidence in the reported results of a study in which a significant minority of participants have already met a key outcome threshold at baseline? If so, can the Guidance Executive point to other studies in the clinical trial literature in which a significant number of participants have already met a key outcome threshold at baseline? Does the Guidance Executive believe that the published PACE papers should have mentioned the fact that a signifiant minority of participants had already met a key outcome threshold at baseline? 
 
6) In February 2016, forty-two leading scientists and clinicians signed an open letter to The Lancet in which they outlined the methodological lapses of the PACE trial, stated unequivocally that “such flaws have no place in published research,” and demanded an independent investigation. In March 2017, more than 100 experts signed an open letter to Psychological Medicine, asking the journal to retract immediately its core finding that GET and CBT helped patients “recover.” Does the Guidance Executive plan to review these open letters and consult with any of the signatories–from Columbia, University College London, Harvard, Stanford, Berkeley, etc.—about their reasons for publicly dismissing the PACE findings as invalid? 
 
7) Both GET and CBT, as described in PACE and other studies from this field of research, involve telling participants that the treatments can reverse the illness and return them to a state of health. Is the Guidance Executive concerned that telling study participants repeatedly about the effectiveness of the treatments could bias their responses, augmenting any bias already inherent in open-label studies with subjective outcomes? 
 
8) Some defenders of PACE note that CBT is also recommended for patients with cancer and other chronic diseases. But the approach advocated in PACE and related studies is not the kind of CBT focused on helping patients adapt to the reality of their illness. Rather, this form of CBT is specifically designed to alleviate patients of their purportedly “unhelpful” beliefs of having an ongoing medical disease that can be exacerbated by activity and exercise. Is the Guidance Executive aware of this critical distinction between CBT as normally administered in the case of other chronic illnesses and the adapted form of CBT investigated in PACE and other studies in this field? 
 
9) The PACE trial used the Oxford criteria to identify participants. This case definition requires only six months of unexplained fatigue, so its use could result in the selection of participants with depression or other unidentified fatiguing illnesses. Some of these other illnesses might resolve spontaneously or respond to behavioral and psychological interventions like GET and CBT. In fact, the NIH report noted that using the broad Oxford case definition could “impair progress and cause harm,” and recommended that it be “retired.” Is the Guidance Executive concerned that populations derived using the Oxford criteria might contain many participants experiencing prolonged fatigue for a range of reasons unrelated to the illness being investigated? Is the Guidance Executive concerned that such heterogeneity in study samples could lead to erroneous findings about treatments?
 
10) The U.S. Agency for Healthcare Research and Quality found evidence to support GET and CBT for ME/CFS in its review of multiple studies. However, when the agency subsequently removed Oxford criteria studies from this analysis, it found no evidence that GET provided any benefits and almost no evidence that CBT provided benefits. Is the Guidance Executive considering this AHRQ re-analysis in its decision-making? Does the Guidance Executive plan to consult with officials at the agency to discuss why they conducted this re-analysis and how it subsequently led them to downgrade their assessments of the therapies? 
 
11) The surveillance review team cites Cochrane reviews of GET and CBT to support the recommendation to leave the 2007 guidance as is. Many of the trials included in these Cochrane reviews rely on a broad case definition like the Oxford criteria. Is the Guidance Executive comfortable relying on Cochrane reviews for confirmation of controversial findings when the reviews themselves include the studies that feature the methodological problems being questioned? Will the Guidance Executive consider asking Cochrane to follow the lead of American public health officials and conduct a re-analysis of its GET and CBT reviews with Oxford criteria studies removed from the sample? 
 
12) In the PACE trial protocol, the investigators promised to follow the Declaration of Helsinki, which requires researchers to tell prospective participants about “any possible conflicts of interest.” The three main PACE investigators have had longstanding relationships with insurance companies, advising them to offer GET and CBT to claimants diagnosed with the illness. Yet the investigators did not tell prospective PACE participants about these extensive consulting and financial links with insurance companies or include the information in consent forms. Is the Guidance Executive concerned that this clear violation of the investigators’ protocol promise to disclose “any possible conflicts of interest” to prospective participants means that they did not obtain properly “informed” consent? Does the Guidance Executive believe it should base clinical guidelines on studies that have not obtained properly “informed” consent? 
 
13) More than 15,000 people signed the ME Association’s online petition outlining their concerns with the 2007 guidance and their objection to the provisional decision to leave it unchanged. Is it unusual for that many people to sign a petition protesting a NICE guidance? 
 
14) Surveys of patients who have undergone GET have routinely found that more patients report harms from the intervention than benefits. In making its decision, does the Guidance Executive plan to consider these reports based on the clinical experiences of patients receiving GET in the real world? 
 
15) The conduct and findings of the PACE trial have become a worldwide controversy. The study has been presented as a paragon of bad science at conferences of epidemiologists and statisticians and in graduate-level seminars. Leading scientists and clinicians have publicly denounced the trial’s perplexing irregularities. The CDC has removed references to PACE and has dropped the associated treatment recommendations. In making its decision about the 2007 guidance, does the Guidance Executive plan to consider that large segments of the scientific and public health worlds have already rejected the evidence base for GET and CBT as interventions for CFS/ME, ME/CFS, or whatever the disease entity is called? Given the public health stakes involved, will the Guidance Executive consider commissioning a more extensive, authoritative, independent and unbiased review of the evidence–and perhaps even a review in which the reviewers read the actual studies on which they are basing their recommendations, and not just the study abstracts?   
 
I have other questions, but will leave it at that for now. I would be delighted should you and/or other members of the Guidance Executive choose to respond.
 
Kind regards–David
 
David Tuller, DrPH
Senior fellow in public health and journalism
Center for Global Public Health
School of Public Health
University of California, Berkeley

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Sir Andrew’s réponse to me:

Dear Dr Tuller,

Thank you for your enquiry.

It looks like you are aware that we have recently concluded a public consultation about our provisional decision on the review of this clinical guideline. We are in the process of reviewing the results of that consultation and will make our final decision in due course. We will make that decision public, together with any other statements we think will be helpful to contextualise it. Until then, we don’t intend to respond to enquiries about the provisional decision. It may be that our final decision, when placed in the public domain, will help you with some of your questions, but if not, we will endeavour to answer them as best we can at that time.

Yours sincerely,

Andrew Dillon
Chief Executive
National Institute for Health and Care Excellence
10 Spring Gardens | London | SW1A 2BU | United Kingdom

Comments on this entry are closed.

  • Anne 14 August 2017, 12:20 pm

    Awesome letter. I hope it will help crack the wall.

  • TeaJunkie 14 August 2017, 12:22 pm

    That was a non-answer if I’ve ever seen one! It’s great if they’ll answer the questions on a post-hoc basis, when the guidelines could be cemented for yet another decade. Thank you for so succinctly and forcefully putting the case forward; the patient-community is forever in your debt, for so courageously and unflinchingly siding with the science, but more importantly, those of us experiencing this waking nightmare. I’ve only lived with this condition for a decade, but given the discourse amongst academics much of this has been so incredibly disheartening; for the first time in ten years I truly feel a sense of hope, and justice, and I pray that you and your colleagues are successful in shining a light on the rotten science as well as the manhandling of patients over the decades. Thank you from the bottom of my heart.

  • Lisa Petrison 14 August 2017, 12:40 pm

    They need to be talking to a wider range of experts on this disease.

  • Scott Simpson 14 August 2017, 12:54 pm

    Thanks you David for keeping the pressure on the UK leaders. We need you to also shine a light on the Canadian Health Minister, essentially a disease denier to the 1.9% of the Canadian population diagnosed with ME and also cross-the-pond victims of the PACE trial.

  • Sam Crowther 14 August 2017, 1:00 pm

    They seem to have no intention of changing anything, despite mounting evidence against their views and practice, and despite patient harm and deaths. I don’t know how they can justify any of this ethically, legally, or morally?

    I am sick of hearing about evidence based medicine, that isn’t based on evidence. The fact that any of this happened in the first place is appalling. But, their lack of ability to make changes and do the right thing by vulnerable people, is…. beyond words to me. To then continue to lack transparency in their process, tells me that what they are doing would not hold up to public scrutiny.

    Their current evidence doesn’t stand up to scientific rigour… or even moral demands. This is murky politics, power, and money at play. If it is anything other than that… then they need to prove it.

    I don’t want to hear anymore about damage to reputations…. I honestly don’t care. Try watching people that you love die, because the UK has decided that we just need to move more, and change our thinking. Try feeling your own body giving up on you while you watch the life that you built crumbling. Then on top of that… to then experience the abuse from the medical system, the social and welfare system… and everything, and everyone else that conforms to the notion that ME is psychological.

    There is no evidence to support the theory that ME is psychological in nature. Yet, if we dare to feel hurt or angry, or upset about how badly we have been treated by so many… then even this is used against us.

    This all needs to stop. Even other countries are distancing themselves from the UK based psychological theory of ME, there is simply no evidence to support it.

    It doesn’t seem to matter what anyone says to these people… they are in power and they will continue to do what they want… regardless of evidence, or public demand, or deaths, or morality. But, I offer a heartfelt thank you, to every single person that continues to try and force the powers that be, to behave like human beings.

  • Lady Shambles 14 August 2017, 1:04 pm

    Tumbleweed. Personally I’d be amazed if you get anything resembling “.. we will endeavour to answer them as best we can at that time.” apropos your very detailed questions.

  • Sandra 14 August 2017, 1:08 pm

    The facts and concerns couldn’t have been stated any more clearly. Brilliant! Thank you.

  • Anil van der Zee 14 August 2017, 1:13 pm

    Wow that was some email. Just amazing. Just as amazing how much of a non-response he gave to you. These questions deserve a real good answer. It’s about peoples lives ffs.

    Anyways, I love the fact that you added the “other studies from this field of research”. It really shows that it’s not only PACE that has been wrong. It’s the whole freaking CBT/GET model itself.

    Dank je wel David!!!

  • Wendy Boutilier 14 August 2017, 1:29 pm

    What they really wanted to say is this: “We are a group of powerful officials who don’t need to answer to you in light of the fact that we enjoy no accountability. Our choices are our own to make and your inquiries make no difference to us. Kindly shut the door behind you and don’t trouble us again.”

  • Joanne Tatum 14 August 2017, 1:47 pm

    Of course, consulting with the specialists and patients would provide the reality of this disease. Many of the sick have tried GET and CBT, and soon crash and become bed bound. It is horrible mistreatment to continue suggesting it! It is criminal!

  • Tina Rodwell 14 August 2017, 1:52 pm

    You are a hero David!

    Right ME association have had a response to their question of who was on the surveillance report that had been compiled in association with certain ‘topic experts’ they are not looking to include charities or patients. http://www.meassociation.org.uk/2017/08/nice-guideline-review-we-hear-back-from-nice-about-the-identity-of-topic-experts-13-august-2017/

    They are also waiting for FITNET to feed data back, considering that SMILE trial has not released the data we could be in for a long wait. Although Andrew Dillon has said they are in the process of reviewing the results of that consultation, it would very much appear they have already have made a decision not to review.

    Furthermore if you look in https://www.nice.org.uk/guidance/GID-CGWAVE0800/documents/draft-guideline which will be reviewed in 2018 it states that recommendations 36-37 page 78 “Chronic Fatigue Syndrome, Fibromyaligia is a functional neurological disorder? Functional symptoms are complaints that are not primarily explained based on physical or physiological abnormalities”. Which goes against WHO and the Department of Health. So what is their game and who is responsible for their actions? we will be waiting for the reply to this from Dr Shepherd?

    So it would seem that;despite all the science, there is no evidence that ME/CFS has any explained physical or physiological abnormalities?

    The response they gave me is here http://tillymoments.blogspot.co.uk/ with my added thoughts for anyone interested, but it was just a load of fluff and nonsense.

    Head brick wall

  • Maggie Wallace 14 August 2017, 1:57 pm

    I’ve lived with ME for 25 years now. Initially I guess I’d be classified as “mild”, but even so I had to give up my part time work as a med lab technician at a time when I had just started looking for full time work when both my daughters were in school. Basically I’ve gone downhill ever since.

    For some reason my GPs have always been kind and supportive, but I’ve heard enough stories from my (mostly online) friends about how badly they’ve been treated by their GPs and other doctors. Not just the ME, but other life threatening conditions that anyone, including ME patients, can have the misfortune to suffer from. I really don’t think NICE have a leg to stand on any more, so I’d like to thank you from the bottom of my heart David Tuller for all that you are doing to bring this travesty of so-called science to public scrutiny.

  • Joan Byrne 14 August 2017, 2:00 pm

    An excellent email David. First class. It covers just about everything thats wrong with the NICE guidelines and why they must be reviewed without the pathetic excuse of waiting on the FITNET fiasco. These people know what they are doing. They cannot claim lack of knowledge or ignorance when the proverbial truly hits the fan. More and more, a legal case is being built up and when the time comes all of those who colldued in protecting their power, privilege, careers and income at the expense of seriously damaging, and in some cases causing the death of, some very ill people, will have to answer for that. I hope its in a court of law.

  • Freespirit 14 August 2017, 2:14 pm

    We need to go above their heads, I presume to the department of health?

  • leelaplay 14 August 2017, 2:15 pm

    Despite the rather snotty response, I’m sure that your detailed list of major concerns about the NICE Guidelines will encourage a more thorough review. Thank you for making clear that the gig is up and the whole world is watching.

    Another point is the “experts” that they asked for advice are from neurology (2), psychiatry (3), paediatrics (1), patient representative (1). They are refusing to give names. However, the balance of ‘experts’ is off for a disease NICE to date has confirmed is not psychological. Charles Sheppard details more concerns in his reply. I think that in interests of transparency, NICE should indicate whether each ‘exert’ holds a biomedical or psychological view of ME and CFS, and where the patient rep is from as none of the major patient groups know of it.

    Also, I believe one of NICE’s initial communications said that they were awaiting the FITNET research to be finished to guide how they revised the guidelines, which in itself seems biased.

    Finally – too tired to check, but didn’t some of the PACE authors take part in one of the Cochrane Reviews that included their own papers?

  • Sean 14 August 2017, 2:29 pm

    The main thing is that Andrew Dillon is now quite aware of the concerns about NICE guidelines in the patient community and will be held to account.

    Whether he chooses to try to change the status quo, we’ll see in time…

  • clark ellis 14 August 2017, 3:06 pm

    NICE will leave the guidance as it. They will say that 1) it was created before PACE and those studies still stand 2) That the treatments do not mean the condition is psychological and 3) that although the treatments are not as good as we would like they are the best we have at present and better than nothing. And 4) that the evidence is that the treatments are safe. I think in tackling NICE it’s important to predict now where they are likely to go with things and start destroying these fallacies before they present them.

  • Sheila Campbell 14 August 2017, 3:15 pm

    Wowee! Brilliant email to NICE, an absolute stotter! Thanks so much Dave.

  • Yvonne 14 August 2017, 3:35 pm

    That is a great letter David. Thank you so much for your persistence and clarity.

  • Barry 14 August 2017, 3:40 pm

    NICE one.

  • Lady Shambles 14 August 2017, 3:44 pm

    Another tack they seem to use is to discard evidence from outside the UK. If they do use this as a reason I would be curious to know whether other disease Guidelines are at the mercy of the same constraint. For eg: cancer , HIV… etc and so on…

  • Alicia Butcher Ehrhardt 14 August 2017, 4:26 pm

    And it doesn’t matter how many people are harmed while you wait.

  • Stephen Wheeler 14 August 2017, 4:56 pm

    Keep on! ……..it’s a physical disease NOT and mental one!…….We must keep the pressure on these idiots!

  • Graham McPhee 14 August 2017, 5:38 pm

    Thanks David. NICE really will have to be watched closely on this one, particularly now that we know that the topic expert group reviewing the evidence consists of three psychiatrists, two neurologists, one paediatrician (and who could that be?) and one patient representative. It’s far from a balanced group!
    http://www.meassociation.org.uk/2017/08/nice-guideline-review-we-hear-back-from-nice-about-the-identity-of-topic-experts-13-august-2017/#comment-6826

    In their guidelines for CFS/ME, NICE say “there is insufficient evidence that complementary therapies are effective treatments for CFS/ME and therefore their use is not recommended,” and yet they also advise “sleep management strategies should not include daytime sleeping and naps.” I have yet to see any evidence to support that advice. My interpretation of that is that “evidence” means either good quality studies or the unsupported beliefs of a researcher with high status.

    As for CBT being recommended for other conditions, I carried out a quick search of their guidelines, and apart from clearly psychological areas, only found three references to CBT: one was for MS, where it was mentioned in one sentence – “Consider mindfulness-based training, cognitive behaviour therapy or fatigue management for treating MS-related fatigue”: one was for those who have suffered a heart attack – “do not routinely offer complex psychological interventions such as cognitive behavioural therapy”: and the third was, of course, for CFS/ME where they dedicated nearly 120 lines to CBT and graded exercise.

  • nancyblake 14 August 2017, 5:51 pm

    The ‘experts’ are a closed and well-protected psychiatric lobby, embedded in the British establishment, the Science Media Centre controlling information to journalists, the Medical Research Council, controlling access to research funding, the BBC, Channel 4, and with influence enough to threaten careers in universities, medicine and the media.
    And, clearly, the NICE Surveillance Committee.
    The experts will be Simon Wessely or a representative, the pediatrician will be Esther Crawley, the neurologist may very well be Jon Stone, who writes and lectures about ‘medically unexplained symptoms’, and is an admirer of Michael Sharpe, who may be another of the unnamed experts. Peter White, the lead author of PACE is now Chief Medical Officer of Swiss Re, a major medical reinsurer, may be another of the ‘experts’.
    In the meantime, Professor Wessely has authored a ‘Guidance for Joint Commissioner of mental health services for patients with medically unexplained symptoms’, a document proposing NHS-wide services for this constructed condition, within which is included CFS/ME, Fibromyalgia, IBS, and pelvic pain – a massive inappropriation of funds which are needed to provide services for the genuinely mentally ill.
    These psychiatrists are defrauding even the agencies who employ them, with the claim that they can cure CFS. The irony is that if we accept this is a viral/autoimmune disorder in which exertion creates damage, but also rest can conserve the energy needed by our immune system to fight it, and therefore, as Ramsay recommended, prescribe complete rest from the start, followed by physical aides and assistance to facilitate improvement, even possibly recovery…..how much money would that save?
    The response of Andrew Dillon makes it absolutely clear that he is in the pocket of this group, and that it is their interests and influence that will drive the outcome. Neither legitimate science, the evidence of patient experience, nor the benefits of appropriate treatment will have any impact whatever.
    Until the establishment itself divests this group of it hegemony over the definition and treatment of this disease, patients will remain endangered by the NICE recommendations, and public funds will continue to be wasted on pointless ‘research’ and ‘services’ which turn mildly ill patients into irreversible severe incapacity.

  • @Tweetyaccount 14 August 2017, 6:10 pm

    Thanks for fighting these dinosaurs! How did they climb to the top of that ivory tower anyway?

  • Jen 14 August 2017, 7:37 pm

    Ditto! I’m too tired to write more than a big thank you, David and ditto what teajunkie said!

  • Steve Hawkins 14 August 2017, 7:39 pm

    In short: a whole industry of CBTologists is almost entirely dependent on keeping us ill for the survival of their cult.

  • Jen 14 August 2017, 7:45 pm

    Invest in ME Research are getting close to funding 2 trials in the U.K. One studying gut microbes and a rumixatab (?) trial. I’m hoping this could help change things in the UK.

  • Peter Trewhitt 14 August 2017, 7:55 pm

    It continues to look like that NICE plan to tow the Psychosocial model party line: to ignore the fact that this unevaluated theoretical model fails to describe the condition and is contradicted by thousands of peer reviewed studies, to ignore the lack of any objective outcomes supporting CBT and GET, to ignore the extensive reports of harm resulting from GET and to ignore the abuse inflicted on patients and more particularly children and their families based on the NICE guidelines.

    The current NICE guidelines are resulting in real harm, are causing avoidable increases in the financial burden of ME/CFS to society as a whole, are wasting scarce health resources by providing demonstrably ineffective treatments and are in practice blocking appropriate assessments and other treatments with a genuine evidence base. The guidelines effectively block the treatment and management of the actual symptoms patients experience, which is the most appropriate response whilst we await a fuller understanding of the mechanisms underlying the condition.

    Further this highjacking of management and treatment of ME/CFS in the UK by an ‘ideologically’ motivated minority has held back the development of any models of good practice and research into the condition itself.

    I am not optimistic that such as David’s very pertinent and direct email will influence them, but it piles the pressure on, and, should we get to the stage where class action law suits are undertaken on behalf of those harmed by these guidelines, makes it much harder for NICE to claim they were just reflecting the best research available at the time.

  • Steve Hawkins 14 August 2017, 8:20 pm

    This whole system of approving highly important, life changing, quasi-legal medical guidelines, by secret committees negotiating behind patients’ backs, has to go.

    How come, in planning and development guidelines and plans, that are not as life or death important as health guidance, there are opportunities to debate the draft proposals at public inquiries, or ‘examinations in public’, after which there still may be a judicial review if matters are not dealt with satisfactorily: yet, when it comes to our health, the public is just told to shut up and leave it to nameless ‘experts’?

    This is a major miscarriage of justice and invites abuse by vested interests in both medical and commercial spheres.

    We must campaign to bring medical guidance notes within a similar system of public accountability to that seen when the planning system was at its best (It is only a shadow of what it originally was after decades of industry lobbying, but it is still at least keeping up more of a pretence of accountability than the health service.).

  • Fay Farmer 14 August 2017, 8:27 pm

    Great email. Keep up the good work David.

  • BaileyFarstad 14 August 2017, 9:40 pm

    Thank you so much for all your hard work for those of us who are too sick to fight for ourselves.

  • Stephanie Kays 14 August 2017, 10:12 pm

    I have been a victim of NICE. I got ME/CFS when accidentally poisoned in utero by highly toxic chemicals that were banned in 1991 just before i was diagnosed in 1994. I was a patient at what was The Royal London Homeopathic Hospital in Great Ormond Street. I was totally revived by my treatments there over time. It all starting going wrong for me in 2011 with austerity cuts by our government. I was turfed out of the hospital when i turned up for my treatment in 2012 with no warning of when that would happen. I was devastated!! I spent a year trying to find ways of getting my treatment replaced, but with only partial success. I was then lifeless for a year & had some extra strange symptoms resulting in a massive subarachnoid brain hemorrhage & Tersons, loss of vision in my right eye & a hemorrhagic stroke leaving my left side not knowing if something is hot or cold, i was in a coma for five days. I have numerous neurological problems, cognitive problems & no appetite or hunger pains now for four years. I walk like a 100 year old Weeble if you remember them. All my ME/CFS symptoms were the worst as was my Fybromyalgia which i had since aged 9. Now i’m slowly on the mend but have an unresolved problem with the what was a 12mm aneurysm, only 9mm has ruptured so i am being monitored for a pending rupture, ticking time bomb. All thanks to NICE.
    The hospital has reopened as the Royal London Hospital for Integrated Medicine & after 6 years i’m allowed back there to see my doctor that i had for 11 years but he can only offer me CBT & GET i have a video for gentle physio
    Many thanks to David for standing up to NICE it’s much appreciated by me!

  • Wendy Matthews 14 August 2017, 11:54 pm

    Thank you!!!! Don’t give up, there’s a heap of us out here who are so grateful you advocate for us when we can’t. Agree that GET and CBT are harmful treatments.

  • Richard Smallfield 15 August 2017, 1:01 am

    Thanks David. A great letter.

    I’ve not read all the comments, but why was the Cochrane Review done by their ‘Common Mental Disorders Group’?

  • Paul_Watton 15 August 2017, 4:06 am

    If NICE really are planning to leave things as they are, then the fear of being taken to another judicial review ought to be made to loom large in his mind

  • Lady Shambles 15 August 2017, 7:23 am

    The results from the Rituxan/ rituximab phase III trials from the Norwegian cohorts are due to be published soon. If I have correctly understood some of what I perceive to be ‘hints’ coming from people associated with B cell depletion / Rituxan research in pwme I’m looking forward to something of significance.

  • Alex Young 15 August 2017, 9:28 am

    I take the view they have declared that they will answer these questions when the decision becomes public. This is an opportunity to hold them to that, and to point out their failure if they do not supply adequate answers.

  • Alex Young 15 August 2017, 9:30 am

    For PACE author involvement in the Cochrane reviews, thedy did things like collaborating on data sharing, reviewing the first paper, and writing the protocol for the second one? The first involvement is expected, the other two put the Cochrane reviews in a bad light.

  • Alex Young 15 August 2017, 9:34 am

    The Rituximab data might be unblinded in about two months. Publication will take time, but we might see a press release by the end of the year.

  • Steve Hawkins 15 August 2017, 9:44 am

    Bit of a sidetrack here: But do you think that you and Vincent could start a ‘TWiME’ podcast? It wouldn’t have to be actually every week, but it strikes me that we could do with a TWIV-style conversation among scientists mode of information exchange.

    I’m listening to the Open Medicine Foundation symposium videos from Stanford and finding it well meaning but unsatisfying in its presentational style and information content. I understand that there were meetings between the scientists earlier in the week, but they then produced these more entertaining–trying not to say dumbed down–slide shows for the general public. I am finding that I’m getting to the end of each presentation having only been given a superficial or even allegorical idea of what each research team is actually doing, and it is beginning to feel rather like time wasting when I could be reading papers from the teams. When one knows they do have unpublished ideas to discuss this is rather frustrating.

    I don’t want to criticise the Stanford videos, as they are following a format that can be found all over the web, and it is fine for people who are coming completely new to a subject, but, to people who are living the life, they are really only useful to see what the researchers look and sound like.

    I don’t think it would be necessary to redo the whole series from the symposium with presentations as they are given to fellow scientists (though it would be good if they were available), and I don’t think that an extended Q&A after the public versions will cover very much ground as it would not thrash out the points as happens in the conversational format. What is needed is a TWiV-style podcast conversation between scientists that would bring out a lot more of the detail of what the researchers are trying to achieve and how it affects our understanding of the disease and fits in with the bigger picture.

    Such a podcast could fit in the latest developments with NICE, PACE, ‘XMRV’-type debates as well as the pure research papers. Having such a platform for debating the science, hosted on a scientifically respected and reliable podcast channel as has been brilliantly built up by Vincent, would be a great asset to the M.E. research world, and become the ‘go to’ place for the latest in unbiased information on progress towards solving this dreadful illness.

    I can understand that Vincent himself would find it hard to host yet another podcast, but I’m sure that a representative ‘TWiME Team’ could be assembled from among the keener researchers and patient advocates/lay scientists and journalists.

    What do you think?

    (I do notice that Vincent already seems to have made a start, in getting all the M.E. linked podcasts and blogs together! Very good!)

  • Peter 15 August 2017, 12:32 pm

    Thanks David. Great letter addressing the many problems with PACE.

    It is nice to see some coverage from U.K. media, but still a long way to go there. Interest is positive, but wouldn’t like to see a shift from describing the

  • Peter 15 August 2017, 12:40 pm

    ….would like to see a shift from describing the “climate” among scientists and “scientists” to more digging into the substance of PACE and all the harm experienced by many patients. It is easy to point out and focus on the climate, but it is not that helpful. So come on UK journalists interested in healthcare and science. Dig deeper!

  • Dx Revision Watch 15 August 2017, 12:44 pm
  • Milo Paradiso 15 August 2017, 1:58 pm

    I would like to know if NICE receives benefit from the BPS lobby in any kind, from gifts, money, schmoozing, awards (knighthood?). I am also wondering who is on that committee who review these guidelines (of course they will not tell us) and whether they are actually considering biological based papers

  • Robert Christ G 16 August 2017, 2:52 pm

    Does seem like a double standard here, if these same authors did a study of the same quality showing vaccines caused autism they would have been tarred, feathered, struck from the register, and drug through the streets. Instead it’s “OK folks, nothing to see here, move along please.”

    Unlike with anti-vax rhetoric which has so far only the potential to do harm, this type of misleading pseudoscience almost certainly destroyed millions of lives over multiple generations.

    And very few give a dam unless it has impacted them directly.

    Thanks David!

  • Leigh 17 August 2017, 6:48 am

    It might be worth someone going through the list of members from the guideline committee and of those that we think are being used on this group take a look at the conflicts of interest they have declared to NICE (available on the ME pages) and see if they are accurate or not. It may be that they have missed out things that they should have declared – even giving expert testimony counts as per the recent court case and The Committee on Publication Ethics. I think this is applicable but brain can’t put it together at the moment!

  • JustinReilly 18 August 2017, 11:51 am

    Thank you so much, David. This is brilliant!

  • GQ 22 August 2017, 12:17 pm

    NICE and Sir Andrew Dillon managed to threaten the claimants in the 2009 judicial review of NICE CFSME Guidelines (CG53) with various threats to the claimants and their legal team. These threats were successful last time. The BPS psychiatrists and NICE are attempting to try to use the same tactics again. The newly uncovered and overwhelming damning evidence about the the PACE trial and its psychiatrists (Sharpe, White, Wessely and Chalder) and the influence of the insurance industry now clearly shows that the original verdict of 2009 was a major travesty of justice. Another High Court Judicial Review appears likely and the biopscychosocial cabal will not succeed this time.

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