The NICE before Christmas

May, 6, 2020 | 13 Comments

Comments

  1. Thanks David for your dogged pursuit in the service of patient safety and better medicine. I’m curious re:”With SSRIs a genital numbness happens in close to 100% of people who take these drugs, within 30 minutes of the first pill, but it was close to completely missed by RCTs and is still, 30 years later, not included in the labels of these drugs.” – did not the EMA pharmacovigilance committee, on 16.5.19 mandate, within 6 months or so, somewhat similar information eg “2. What you need to know before you take [Invented name] Warnings and precautions Medicines like [Invented name] (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.” Although this understates, it ought by now be “in the labels” – is it not? I expect no progress with FDA as yet, or we’d have heard.
    With great respect, Rob Purssey

    • Rob

      Thanks for the comment. The point here was not about PSSD and EMA trying to get it in the label – its about the fact that RCTs can totally miss something happening on these drugs to virtually everyone who takes them – genital numbness. And this is still not in the label although there are slow moves to include PSSD.

      This is a point I tried to bring out in what I think is the most important lecture I have ever given – Does my Bias look Big in This – the blog on March 18th – which says that our belief in RCTs is the greatest thing getting in the way of patient safety. See https://davidhealy.org/does-my-bias-look-big-in-this/

      David

  2. ‘Struggle without it’ …

    “If some young health professionals feel that they have to, better that they rely on our guidance than struggle without it, or worse, use less authoritative sources (if you’ll permit me to promote my own organisation)”

    Ah well, so Dillon is admitting that Doctors are unable to think for themselves without ‘authoritative’ NICE guidance..

    These letters are steeped in bureaucracy; Heads of organizations who have been trained to be a bureaucrat since they came out of short trousers.
    Plenty of those around at the moment..

    Bringing Alltrials in to the frame was just fanciful thinking.
    Of course, GSK was the first pharmaceutical company to sign up.
    They know when they have a gift horse in the mouth..

    “I haven’t formed the impression, in the contacts with the people involved, that they apply the guidance uncritically.”

    Where is the evidence for that statement?

    “I don’t know who else you can approach to engage in this. The academic health science networks perhaps? Google, or one of the other new players in the data crunching business? Meanwhile, we’ll keep on going in our admittedly flawed way, to try and keep patients and health professionals safe.”

    GSK hits back over ‘alarmist’ antidepressant analysis

    “it is important to emphasise that “regulatory bodies around the world have conducted extensive reviews of published and unpublished data for licensed antidepressants and have concluded that these medicines provide benefit to patients”.

    http://www.pharmatimes.com/news/gsk_hits_back_over_alarmist_antidepressant_analysis_987597

    Only 16 out of 170 paroxetine trials included

    GSK says that “contrary to what has been reported”, the study has only examined a small subset of the total data available for antidepressants. With paroxetine for example, “this study only considers data from 16 trials out of a total database of more than 170 trials involving at least 14,000 patients”. With regards to Paxil, “.all trial data published and unpublished were submitted to regulators, at the time of registration”, GSK notes, saying that all the data related to paroxetine, “regardless of study outcome”, are available at the company’s clinical trials register on its website.

    A GSK spokesperson added that the firm “rejects any suggestion that we deliberately withheld data on paroxetine” from the UK’s National Institute for Health and Clinical Excellence, which is due to review its guidance on treating depression. The spokesperson said that the firm provided both published and unpublished data as part of the development of the NICE guidelines regarding the licensed use of paroxetine in adults with depression, anxiety disorder, post traumatic stress disorder and obsessive compulsive disorder.

    They are all going about it in an ‘admittedly flawed way’ …

    Skirting around the issues, does not pacify …

  3. Thankyou Dr Healy for all you do.
    And thankyou for sharing this correspondence.

    “Meanwhile, we’ll keep on going in our admittedly flawed way, to try and keep patients and health professionals safe.”

    in other words,… we have no idea what to do but hey the public have been misinformed for decades so why change that now….we are gonna just carry on with delusional thinking, giving directions from nowhere, giving blither and referrals to people who raise questions, and of course continue betraying the publics trust and pushing pharma propaganda.

    In the case of thalidomide they could only get away with blaming the mothers for so long I guess because of the visual horror but in this situation we have a mental thalidomide that has a horror only seen by the one swallowing it or trying to stop swallowing it. And the medical profession is continuing to get away with blaming the patient.

    “people starting out tell us that they appreciate the steer that our guidance gives them”
    what the heck!!

  4. As someone who worked for a good time as a mental health advocate I was so reassured to find the work of Dr Healy – And from this I know that the work has already benefited clients I have worked with. It is clear that there is a growing band of people looking at things straight in the face and speaking and acting with integrity and care.
    Thank you.

  5. The line above Kiwi’s line really tickled me..

    “I think you’re being a little hard on NICE. I imagine that you’re some way into your career,”

    00..

    Health Secretary Matt Hancock added: “Sir Andrew Dillon has made an immeasurable contribution to the NHS during his 20 years as chief executive of NICE.

    “Under his leadership, NICE has become the world’s leading authority for providing clinicians and government with independent, clinical evidence about the effectiveness of treatments and medicines.

    “This has been central to building the UK into the world-leader in life sciences and innovative treatments that it is today.”

    https://www.nice.org.uk/news/article/sir-andrew-dillon-to-stand-down-as-nice-chief-executive

    As he throws Neil Ferguson … under a bus

    Matt Hancock says he backs any police action against Neil Ferguson

    https://www.theguardian.com/world/2020/may/06/neil-ferguson-right-to-resign-for-breaking-lockdown-rules-says-minister-coronavirus

    Call the police … arrest Matt Hancock

    https://rxisk.org/pssd-and-hancocks-half-brexit/

    Hancock’s half hour ..

  6. lol yes annie that line raised my eyebrows too.

    Thought I’d do a wiki on Andrew Dillon.

    “He joined NICE as its founding chief executive in 1999.
    In September 2013 he wrote an open letter to The Times in which he said companies should be sure that all expenses spent on research were necessary in order justify the high prices demanded for new products assessed by health technology assessment (HTA) bodies such as NICE: “If it really does cost £1.2bn to develop a new drug, the question the pharmaceutical industry must be able to answer is this: are you absolutely confident that it needs to?”
    He was said by the Health Service Journal to be the 34th most powerful person in the English NHS in December 2013 and among The 25 most influential people in biopharma today. As of 2015, Dillon was paid a salary of between £185,000 and £189,999 by NICE, making him one of the 328 most highly paid people in the British public sector at that time.”

    My guess Andrew is its about $100,000 for the research and its about $1.1 billion for advertising propaganda.

    Well I can think of some better questions he could have asked, like this one for example…
    The question the pharmaceutical industry must be able to answer is this: What are you going to do about SSRI induced suicidality.

  7. https://hsruk.org/sites/default/files/upload/Changing%20Healthcare%20Event%201%20synthesis%20pack_0.pdf
    https://www.kscopehealth.org.uk/person/david-haslam/We find new solutions to old problems
    We run engaging events, enabling people to learn from each other, free of divisions. Such as our work with Public Health England.
    Next we explored how NICE
    has and continues to practice
    and promote the use of
    evidence so well.
    Through two short talks,
    questions and reflections, we
    considered how NICE has
    previously used evidence in
    system change, the challenges
    it has faced
    Tara Lamont, board member of
    Health Services Research UK,
    explained how NICE has enshrined
    evidence as cornerstone of clinical
    practice through its careful,
    transparent and contextualised
    approach

    Quality of evidence
    ● We need high quality evidence and a way
    to speed up getting it.
    ● We’re not just lacking quality evidence,
    there’s not enough evidence full-stop.
    ● Start using ‘real world data’ to supplement
    RCTs – there’s so much data we cannot
    pick up quickly enough otherwise.

  8. Musical chairs as ever …were Andrew D and Haslam pushed off theirs – Is it murder or suicide ? NICE has some of the guilt for so many avoidable deaths Already these two are spouting the usual blah they soak up
    NICE has appointed Prof Gillian Leng as its new chief executive, completing its top leadership search after new chair Sharmila Nebhrajani was confirmed a few days ago.

    The cost-effectiveness watchdog has looked internally for its new CEO, opting to maintain continuity in its senior management. Leng has been deputy CEO at NICE since 2007 and is also currently director of health and social care at the agency
    “I look forward to working with the Institute’s staff and stakeholders as we enter an exciting new chapter of innovative changes to deliver our portfolio of guidance into the hands of frontline staff in an easy and intuitive way,” said Leng.

    NICE has been searching for a replacement for Sir Andrew since he announced his retirement last year.
    With former chair Sir David Haslam announcing he was also stepping down last year – the organisation has been juggling a big change in top management even as it rethinks its methodology in the light of new developments in pharma.

    At a pre-appointment hearing by the government’s Health and Social Care Committee last week, Nebhrajani said………. were putting NICE under pressure as it tries to Restore Stable Leadership. (interesting give away?)

    At the health technology assessment (HTA) body she has been responsible for setting up and operating the clinical guidelines programme, amongst other duties, and also oversaw the transfer of the National Prescribing Centre into NICE and the establishment of the NICE accreditation programme.

    Don’t miss your daily pharmaphorum news.
    SUBSCRIBE free here.

    Sharmila Nebhrajani has been confirmed as the new chair of the National Institute for Health and Care Excellence (NICE) after a pre-appointment hearing by the government’s Health and Social Care Committee.
    At the meeting, Nebhrajani said the key challenges facing NICE include a hefty workload and a change in both the chair and chief executive roles “after an extended period of leadership stability.”

    There is a need for priorities to be set so that urgent guidance can be updated quickly, and the guidelines prepared for the NHS are “relevant and useful”, she told MPs.
    The new chair should be judged on how quickly strong leadership with the CEO can be restored, ………. said Nebhrajani.

    Risks facing NICE include increased cost pressures from new therapies that will require the agency to change the way it has traditionally operated.
    That includes new personalised medicines that are placing “upward pressure” on its quality-adjusted life year (QALY)

    She stressed the importance of NICE remaining “at arm’s length” from government and ministers and said that her own independence “will be preserved by maintaining an open, even handed but respectful distance from any one set of stakeholders.”
    Nebhrajani will join the agency at a critical time in its history, as it tries to……. and navigates a review of its procedures and appraisal processes.

    She will also step down as a non-executive director of the British Medical Journal (BMJ) on taking up the position of NICE chair, telling MPs the latter role presented “a substantive conflict of interest”, and is taking advice on a voluntary role as a governor of the Health Foundation charity.

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    SUBSCRIBE free here.

  9. As a result of the growth of evidence-based practices across the world, health-care providers and policymakers in the United States, United Kingdom, and Europe have established institutes such as the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) to produce clinical guidelines that physicians are asked to use in their daily practice. This article discusses how the withholding of clinical trial information by pharmaceutical companies and academic researchers affects the reliability of clinical guidelines. It first offers a case study analysis of the U.K. drug regulator’s failure to prosecute GlaxoSmithKline, manufacturer of the bestselling antidepressant Seroxat (manufactured as Paxil in North America), for withholding information on the safety of Seroxat from regulators. It next examines the idea of a “Sarbanes- Oxley for Science,” a recent proposal that seeks to introduce legislation forcing companies to disclose clinical trials that have indeterminate or negative results. Legislation such as Sarbanes-Oxley for Science would solve some problems with the withholding of data, but not all. Until practitioners and policymakers address the political and legal barriers preventing full access to clinical trial data for all medical treatments, the ideals of evidence-based practice will remain elusive.

    DH 2 DH

    https://davidhealy.org/dh-2-dh/

    MHRA 2 NICE

    Sequestered Evidence and the Distortion of Clinical Practice Guidelines
    https://www.researchgate.net/publication/236726522_Sequestered_Evidence_and_the_Distortion_of_Clinical_Practice_Guidelines

    At first, the MHRA’s decision to post trials on its Web site suggested that the
    agency was invested in helping ensure NICE had full access to trial data.
    My interview with Woods, however, suggests this may not have been the case:

    LM: Would you like to see a move to a system where NICE had access to the same data as the MHRA?

    KW: No.

    LM: Why not?

    KW: It’s important to understand firstly what NICE is there for. NICE is an NHS organization. Its job is to give advice and guidance to the NHS. I mean, the NHS is just a very large health maintenance organization.We have a statutory responsibility to the nation as a whole, and therefore our remits are somewhat different. The second thing is that is it far preferable that we are able to communicate to NICE at a confidential level, so that NICE is able for instance to organize their work programme, and to plan when a product is likely to come up for appraisal, than NICE having access to the
    raw data that we see.

    LM: As a former clinician yourself, as an epidemiologist, are you worried
    about what people like Chalmers have talked about, which is the
    general integrity of evidence bases.

    KW: I know one of the things that bothers Iain [Chalmers]. And maybe this is what he has referred to. That companies submit to NICE the data they chose to submit. They submit to us, under legal obligation, all the data they have. And so, in a way, NICE is working
    at a disadvantage.2

    In theory, and in the view of practitioners I have spoken with, there should be a close degree of coordination between NICE, which produces national treatment guidelines, and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) which is responsible for the licensing and post-market surveillance of all medicines and medical devices in Britain.

    This is because the MHRA, as the government drug regulator, has a statutory duty to protect U.K. consumers from unsafe treatments. Clinicians assume that the MHRA and NICE are working in concert to ensure that treatments recommended in NICE guidelines have passed through rigorous safety standards safeguarded by the MHRA. As the case below reveals, however, much conflict exists between NICE policymakers and MHRA staff, conflict that in the case of SSRIs prevented NICE policymakers from accessing clinical trial data necessary for formulating reliable guidelines

  10. The new chair of NICE is a bit confused . Sharmila N. is wondering whether she should step down from her position as voluntary Governor of The Health Foundation which receives funding of £37million,-as well as from her Non Executive Position with thebmj
    – The Health Foundation has these partnerships with thebmj

    What we (H F) do -Funding and partnerships

    BMJ Improvement Hub
    High quality evidence, practical tools and resources designed to help those seeking to improve the quality, safety and person-centredness of health care.

    https://www.health.org.uk/funding-and-partnerships/our-partnerships/bmj-quality-improvement-series

    https://www.health.org.uk/funding-and-partnerships/our-partnerships/bmj-quality-safety
    improvement-series

  11. Shamila N the newly appointed Chair of NICE is wondering whether she should resign from the Health Foundation .She has resigned as Non Executive Director of TheBMJ . but The Health Foundation ( Which receives £37million in funding )still has partnerships with Thebmj. S.N.is seeking advice about her role as Govenor of the Health Foundation.(anybody?)

    What we do (H F) Funding and partnerships

    https://www.health.org.uk/funding-and-partnerships/our-partnerships/bmj-improvement-hub

    https://www.health.org.uk/funding-and-partnerships/our-partnerships/bmj-quality-improvement-series

    https://www.health.org.uk/funding-and-partnerships/our-partnerships/bmj-quality-safety

  12. Yesterday upon the stair
    I met a man who wasn’t there
    He wasn’t there again today
    I wish, I wish he’d go away

    Aye, NICE…

    Interested to find out more, I wrote to NICE Seeking further clarification on this development. NICE outlined that they had offered a meeting to the “authors of the 17th November letter to discuss their concerns with them”. The meeting apparently took place on 27th April and following this “NICE decided to run a second consultation.”
    I asked NICE where the public could access the minutes of this meeting and was informed that “the meeting on 27th April was not minuted or otherwise recorded.”

    Given the call for transparency by this group I was most disappointed to find this. I therefore wrote to one of the signatories of the letter asking if any informal minutes of this meeting with NICE could be shared. I received this reply: “I don’t I am afraid agree that you have any right to see any of minutes, any more than you would have any rights to hear a transcript of a conversation I had yesterday with a bloke in the pub about some recent NICE guideline and what we should do about it.”

    https://holeousia.com/2018/06/24/demand-full-revision-of-nice-guidance-on-depression/

    ‘n correspondence with Professor Sir Simon Wessely he suggested that I make a Freedom of Information request to NICE. I have followed this advice and have now received the following four documents (shared here below as received).

    I also share here, to provide full, open, and transparent context, the correspondence that I had with Professor Sir Simon Wessely. I will let the reader decide on whether this is the correct thing for me to do or not. I have concerns that such a powerful and influential UK medical leader should confuse transparency about a matter of public interest with me as a person and then challenge my probity.

    https://holeousia.com/2018/07/12/transparency-revision-of-nice-guidance-on-depression/

    Simon says…on Vimeo..

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