In Orders from Nowhere, Vaughan Gething suggested writing to Andrew Dillon of NICE. The correspondence had an Xmas Eve denouement – hence the title.
It seems everybody figures NICE hold all the answers. The doctors who treated Stephen O’Neill claimed to be keeping to NICE Guidelines and only using drugs licensed by MHRA. They also conceded that Stephen was suffering from sertraline toxicity. See if you can spot any hint of NICE Guidance on managing SSRI induced suicidality in this correspondence. Get in touch if you know of any drug any regulator in any universe has approved for the management of SSRI induced suicidality.
Re NICE Guidance
Dear Andrew Dillon
I recently sent versions of the attached letter to a number of Ministers/Departments of Health. Vaughan Gething suggested taking “my” concerns to you and to June Raine – attached. Mr Gething’s Department may not understand MHRA’s brief and so I am copying Dr Raine in here rather than writing separately.
The correspondence arose from a recent inquest at which I testified which returned a conclusion I regard as wrong and potentially compromising of the wider public health. This led to the attached letter to Michelle O’Neill MLA.
A key reason for this incorrect conclusion lay in the patient’s GP and later hospital doctors testifying they did not believe the literature on antidepressants was ghostwritten and they were fully adherent to NICE guidelines. They also stated they had used drugs approved by MHRA, internationally recognised for their excellence in these matters – the implication seemingly being that if approved by MHRA these drugs could do little harm.
Full adherence to NICE Guidelines and using a drug approved by MHRA seems to have persuaded the coroner to override a conclusion that I’d expect most people exposed to the facts of the case would have adopted.
A group of good doctors in this case have been misled by misunderstandings about NICE. In 2004, a NICE group working on Guidelines for the treatment of paediatric depression, drew attention to this hazard in an editorial in the Lancet – Depressing Research.
I testified about this hazard a few weeks later to a House of Commons Select Committee and I have been doing so at regular intervals since under oath in court, in peer-reviewed articles, in books and lectures – for instance in a public lecture in the Welsh Senedd building a year ago – and in an open letter to David Haslam earlier this year and in recent letters.
I can see constraints on any response you might offer and it’s not the job of NICE to police the academic literature. I will write to Mr Gething, telling him it’s my job not yours to alert him to this risk. The public though will likely want someone to tackle it.
Professor David Healy MD FRCPsych
From: Andrew Dillon, Sent: 20 December 2019 12:22
To: David Healy (BCUHB) ; ‘firstname.lastname@example.org’; et al
Subject: RE: Letter to M Hancock
Dear Professor Healy
Thank you for this and your earlier emails. I am sorry that you didn’t receive a response to your letter to David Haslam. He would have referred it to me for action and so the responsibility is mine.
The two main themes in your correspondence touch on the notion of ‘bureaucratic medicine’ and the provenance of the evidence that NICE takes into account when developing its guidance.
I know that you will be familiar with David Sackett’s definition of evidence-based medicine (BMJ 1996; 312:71-72). His description of a “conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients” and his view that “the practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research” continue to be an important reference for NICE. Our guidelines are just one element of evidence-based care, alongside clinical judgement and the values and preferences of individual patients, a position we capture with these words, which appear in each guideline:
The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals and practitioners are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or the people using their service. It is not mandatory to apply the recommendations, and the guideline does not override the responsibility to make decisions appropriate to the circumstances of the individual, in consultation with them and their families and carers or guardian.
The issue of unpublished evidence is a challenge for anyone using evidence to inform treatment options. As you point out, the authors of our Depression in Children guideline drew attention to the problems caused by unpublished evidence some years ago. Since this guideline was published, there has been some progress in addressing the issue of unpublished evidence and positive bias in the published literature. Researchers are expected to follow the Good Publication Practice guidelines, which includes medical writers being named in the acknowledgements of papers.
Since 2016, the EMA has made all clinical data submitted to them for the marketing authorisation applications of new medicines available through a dedicated website (https://www.ema.europa.eu/en/human-regulatory/marketingauthorisation/clinical-data-publication).
This means that all clinical data that was used by regulators is accessible to everyone within 60 days of marketing authorisation (after registering for access to the database), whether or not is has been published.
Of course, these procedures were not in place when most SSRIs were approved, but post-marketing surveillance can trigger regulatory action and the EMA completed a referral procedure on SSRIs and suicide in 2005:
We agree with you that it is not NICE’s role to ‘police’ the academic literature, but we take the matter seriously and we are a AllTrials campaign which calls for all past and present clinical trials to be registered and their full methods and summary results reported.
Chief Executive National Institute for Health and Care Excellence
From: David Healy Sent: 23 December 2019 14:22
To: ‘Andrew Dillon’; ‘email@example.com’; et al
Subject: RE: Letter to M Hancock
Many thanks for your response, which I read as an invitation to push at a partially open door. I might agree with your characterization of my concern as being with “bureaucratic medicine”, if you are willing to extend bureaucratic to include management. Health seems to me to have become a service industry and it’s the management (bureaucratic) processes common to such industries that are now putting us at risk.
In August 2018, I wrote to Vaughan Gething detailing similar concerns. I attach this letter – omitting the local service issues it also covered.
Dr Frank Atherton, the CMO in Wales, responded (letter attached) saying:
I recognise some of the structural constraints you describe – these are not easily corrected, appearing as they do in all advanced healthcare systems. My suggestion would be for you to continue to engage with others who share similar views; collective analysis and advocacy are more likely to change systems than individual efforts.
With this advice in mind, and your response, this email seeks to engage a wider constituency.
We agree on what David Sackett said and I imagine you noted in my response to Leigh Smale that I referred to NICE Guidance rather than Guidelines. I am sure you are also aware that de facto NICE Guidelines have become something doctors either must, or feel they must, adhere to rigidly.
And even for doctors who view NICE as offering Guidance, the influence of the unpublished evidence can seriously skew that Guidance in a manner difficult to gainsay. By unpublished evidence I don’t mean trials that are never published, I am more concerned about trials published claiming efficacy and safety when the unpublished data suggests the opposite.
As regards unpublished evidence in general, I imagine the Dept of Health will be reassured by the points you make. I don’t wish to gainsay the impression that NICE are at least trying to do something, but I do need to spell out how from the point of view of someone concerned about safety, what has been done risks making the problems worse.
In the case of the articles on pharmaceuticals NICE works from, as you note Good Publication Practice boxes are more likely to be ticked than before – by the ghost writers. But the notional researchers (the apparent authors) are less likely to have seen or analysed the data from any of these trials than they were in 2004.
In agreeing with your suggestion that things have moved on since 2004, many readers of your email will likely forget that the pharmaceutical industry and health service companies have more incentive and resources to keep ahead of the game than anyone else – leading to “not easily corrected constraints that apply in most advanced healthcare systems” as Dr Atherton recognises.
In 2004, the BBC in particular were able to assist us all in tackling issues that appeared to be rotten apples in a barrel, but they seem unable now to get any purchase on what seem rotten barrel problems – tellingly illustrated for me in the failed efforts of two recent BBC programs to get answers from NICE on matters involving antidepressants and children.
Although NICE has access to regulatory material it didn’t have in 2004, this is not the raw data. Having been involved in the consultation process regarding access to data that EMA began in 2012 and liaising regularly with colleagues who have availed of EMA’s data offerings, I know that EMA now make available Company Study Reports (CSRs).
They do not make available Clinical Record Forms (CRFs) which are closer to the data. CSRs written in the late 1990s were likely more innocent than CSRs written since companies became aware that their CSRs might later be scrutinized. But, even in 2004, the account CSRs offered were only slightly less rosy than published articles that led to indictments for fraud.
Your suggestion that regulators do not operate on the basis of the raw data accords with my understanding. Their use of any extra data to which they might have access is for audit purposes rather than analysis. In this respect nothing has changed since 2004.
For someone concerned about the safety of drugs, the AllTrials initiative you mention compounds the problems. RCTs and AllTrials focus on efficacy. This focus makes RCTs the gold standard way to hide adverse events – as outlined in a recent BMJ article I co-authored, (as part of a collective effort to analyse the problem). In adding to the premium put on RCTs, the impression generated by AllTrials, that we are now forcing companies to make key data available, as I see it adds to the inability of prescribers to see the harms they are causing – as demonstrated in the O’Neill Inquest.
From my point of view, if AllTrials hadn’t existed the pharmaceutical industry might have had to invent it – and they were quick to sign up to it.
The post-marketing surveillance that might counter-balance the premium put on RCTs isn’t working. My reason for initiating this correspondence was that the recent O’Neill inquest is a telling example of how things are getting worse rather than better.
The SSRIs give the lie to the standard response given to soothe policymakers and others that of course there are some events too rare to be picked up by RCTs, or that happen only after months or years of exposure, for which we need post-marketing surveillance. 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.
This is not a matter of improving our post-marketing surveillance methods – it’s a matter of re-empowering doctors and patients to notice problems happening commonly and in front of them – as Sackett would have wished – and developing methods to manage those problems as we did 50 years ago in the case of drugs like lithium but don’t do now. In the absence of any Guidance on how to handle treatment induced suicidality, the doctors in the O’Neill case flailed around and it seems to me contributed to a death that should not have happened.
I don’t hold industry or regulators to blame for this – I blame doctors and, in particular those who have held themselves out as experts on pharmacovigilance.
Most doctors now are too young to remember that 20 years ago we had a regular stream of publications like Drugs and Therapeutics Bulletins, reminding us that drugs are unavoidably unsafe. Very few of us read NICE Guidelines.
Now every medical student learns NICE Guidelines and parrots them back in order to pass their exams. These essentially only outline the benefits of treatments – and few younger doctors have ever seen a DTB.
Most doctors work in Family Medicine and depend on specialists like me – who are either the very people whose names are on the ghostwritten articles or whom they will feel too uncomfortable to ask back to speak if my message is at odds with NICE Guidance. I’m reluctant to speak to doctors in training as they’d fail their exams if they listened to me.
When it comes to adverse effects, regulators, in practice, strip away the names of patients from reports of problems, transforming these into hearsay and making it impossible for the regulator ever to link an effect to treatment. MHRA have had reports of Post-SSRI Sexual Dysfunction (PSSD) on their books for 30 years, and may now have over 1000 such reports, but seem incapable of regarding these reports of a problem that is leading young people to seek assisted dying as anything other than a signal.
We would all be a lot safer if RCTs, increasingly conducted in developing world settings, with invented patients, and notional investigators unable to attest to the reality of anything that has happened in the trial, were regarded as hearsay.
It would also help if regulators made the kind of efforts that companies make to determine whether their drug causes a problem, which involves consulting with patients and doctors as to what has happened and often deciding their drug has in fact caused a problem.
I have not gone into the details above in order to castigate NICE. We agree this is not primarily a problem for NICE –other than perhaps being seen as a fall-guy for doctors who don’t read or don’t understand the small print in the Guidelines. It’s rather difficult to pinpoint whose problem it is and I’d be grateful for any suggestions you might have in this respect.
As regards my efforts to engage a wider group of stakeholders, I will bundle up the recent correspondence about the O’Neill Inquest and ensure all Depts of Health in these islands get a copy. Unity on important issues seems lacking at the moment. Perhaps all 4 countries will be able to unite – in rejecting, or side-stepping, my concerns.
Other stakeholders that come to mind are some of the Royal Colleges, and the BMA.
From: Andrew Dillon Sent: 24 December 2019 10:32
To: David Healy (BCUHB); ‘firstname.lastname@example.org’ et al ;
I’m not really sure how to respond to this, to be honest. I’m not so naïve as to imagine that clinical trials are always either complete or completely accurate. I know that you’re not implying that, but it’s worth saying anyway. Our advisory committees are not uncritical either. It’s through the committee’s, applying our methods, that we can expose uncertainties and risks and try to reflect them in in our guidance. (by the way, when we refer to NICE ‘guidance’ we mean all the various forms of advice we publish, which includes our clinical, public health and social care ‘guidelines’).
I think you’re being a little hard on NICE. I imagine that you’re some way into your career, but people starting out tell us that they appreciate the steer that our guidance gives them. Interestingly, views are expressed on both sides of the argument about the extend to which our recommendations direct practice, as opposed to encouraging informed judgement. Both have their place, I think; the former particularly when there is a need to communicate a clear signal about safe practice. Through our Fellows and Scholars and prescribing advisors (clinical pharmacists) programmes, we reach significant numbers of health and social care professionals with a message about the extent and the limitations of NICE guidance. I haven’t formed the impression, in the contacts with the people involved, that they apply the guidance uncritically. 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).
I was interested in your point about ‘regulators (making) the kind of efforts that companies make to determine whether their drug causes a problem, which involves consulting with patients and doctors as to what has happened and often deciding their drug has in fact caused a problem.’ If by that you mean we should be tracking the effect of our recommendations, including the extent to which known as well as unanticipated risks have materialised, I would agree. Our ability to do that is limited partly by the availability of data and partly by resources. However, we are investing in an enhanced data analytics capacity, which we hope will put us in a better position to do this.
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.
Unbeknownst to me, Andrew Dillon had indicated a few weeks earlier that after 21 years at the helm he was stepping down as the CEO.
He was widely praised by the Association of the British Pharmaceutical Industry (ABPI), among others, who mentioned his contributions to transparency.
David Haslam, the Chair of NICE, along with Andrew Dillon, an honourable man, is also stepping down.
Twas the NICE before Christmas
When all through the house
not a creature was stirring not even a mouse…
When it comes to the adverse effects of drugs, there is not a stir. The liberal media – the Guardian and New York Times, the BBC and PBS once stirred the shit. No longer. We don’t want to stop people believing in Xmas. They can’t be put off taking the sacraments – things that can only do good and cannot do harm.
And this is in great part down to NICE a creation of the Labour Party – who simply do not want to hear that the academic literature on which Guidelines are based is Fake through and through. A series of honourable men have presided over this, award winning journalists won’t go near the issue, Brenda Hale who tackled Boris Johnson doesn’t want to know and doctors… well doctors.
Meanwhile in terms of Guidance on managing SSRI induced toxicity, or any drug toxicity, you’d be better off asking St Nick before he takes off in his sleigh than anyone in NICE or MHRA, FDA or EMA.
Ask your doctor? Well doctors… BMA have been copied in to all this. Not a peep.Share this:
Copyright © Data Based Medicine Americas Ltd.
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
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/
‘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”.
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 …
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!!
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.
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,”
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.”
As he throws Neil Ferguson … under a bus
Matt Hancock says he backs any police action against Neil Ferguson
Call the police … arrest Matt Hancock
Hancock’s half hour ..
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.
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
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.
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.
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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.
Don’t miss your daily pharmaphorum news.
SUBSCRIBE free here.
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
MHRA 2 NICE
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?
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
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.
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
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
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.”
‘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.
Simon says…on Vimeo..
Where Are They Now?
Helping (themselves) to charities after collecting their gongs https://www.centreformentalhealth.org.uk/about-us
Andrew is here -https://www.theguardian.com/society/2008/aug/29/nhs.health – so are the apalling Mental Elf and Sue Bailey , Wendy Burns is associated
Home News Centre welcomes Professor Kamaldeep Bhui to its Board of Trustees
7 February 2020
Centre for Mental Health is delighted to announce the appointment of Professor Kamaldeep Bhui as our newest trustee. As the Head of Centre for Psychiatry at Queen Mary University of London and Honorary Consultant Psychiatrist at East London NHS Foundation Trust, Kamaldeep brings a wide variety of experience to the Centre’s board. His work has included tackling health inequalities, cultural and preventive psychiatry, and working closely with communities in public mental health.
Kamaldeep’s experience is of assertive outreach and homelessness services, social and cultural psychiatry, epidemiology, health services research and psychological therapies (he is a psychoanalytic psychotherapist as well as a psychiatrist). Kamaldeep is the Editor of the British Journal of Psychiatry. He has a particular interest in young people’s mental health, violence prevention (including gender violence and extremism), and promoting and protecting health and wellbeing.
Speaking about his appointment to the board, Professor Bhui said:
I’m delighted to be joining the Centre for Mental Health, an incredible charitable organisation that has improved practice and policy on mental health for over three decades. I hope to strengthen research and evidence-based practice and policy, especially to protect the interests and welfare of underserved and excluded communities, including those with mental illnesses and other sources of discrimination, stigma and clustered disadvantage.
Chair of Trustees, Professor Dame Sue Bailey ex president coll of psychs..said: “Centre for Mental Health are both fortunate and excited to have Kamaldeep join the Board of the Centre. He brings with him from across all his richness of knowledge, skills and expertise a quality that lies at the very heart of the work of the Centre: a social justice approach to improving mental health outcomes for all.” Clap clap
Using the link provided by Annie recently (thanks very much Annie) re the actions being taken by the Health Minister in Australia I wrote to Vaughan Gething to ask what action is being taken re suicides of children with reference to prescribing of anti depressant in Wales.. And received a piece of nonsense from un-named correspondence office referring me to the letter the above. I replied saying obviously I knew of that response as I had forwarded it myself and repeated a request as to what is being done presently. Also requested to be told who was on the Health Cttee . Maybe he had a word with V G by then as my e mails were then blocked.3 of 6
Mon, Jun 15, 9:32 PM (2 hours ago)
Your message to Vaughan.Gethin@assembly.wales has been blocked.
Date: Mon, 15 Jun 2020 21:32:35 +0100
Subject: Health Minister orders review after study links antidepressants and youth suicide
The attached shows what action other countries are taken to remedy the issue of harms to children from anti depressants
Can you please outline what steps are being taken in Wales
Seems Ann Neagle is Chair of the Childrens’ Cttee. She has expressed concern about thiss and has several twitter messages stating that. This is the report they commissined. Not a squeak about anti depressants. Unfortunately influenced by Papyrus as are the Childrens’ Commissioners of Wales and England:-
Young suicides in Wales due to ‘complex’ reasons, says study
16 December 2019
Research, published by Public Health Wales and Swansea University, examined the deaths of 33 young people aged 13 to 18, over a four-year period.
There was rarely a single reason why they had taken their own life.
The study said stigma related to self-harm was a “major challenge” and could be preventing families seeking help.
Lynne Neagle AM, who chairs the Welsh assembly’s cross party group on suicide prevention, said she believed it was “nothing short of a public health emergency”.
Reducing Adverse Childhood Experiences (ACEs) was among key ways of preventing suicide, the study said.
The major study is a follow-up to a research project which reported in 2014.
It follows evidence from across the UK of an increase in deaths by suicide in young people since 2010. Statistically, it is not possible to detect differences in the suicide rate in Wales because of the small numbers involved.
What were background issues to the suicides?
Adverse childhood experiences
Risk factors in young suicide cases
Category Yes No
Verbal/emotional abuse 5 24
Physical abuse 5 24
Sexual abuse 5 24
Sexual assault 3 26
Parental separation 18 11
Household domestic violence 7 22
Household mental illness 8 21
Household alcohol abuse <3 27-29
Household drug use <3 27-29
Household member in prison <3 27-29
Neglect 4 25
Bullying 10 19
Bereavement 6 24
ACEs in four cases could not be determined
Source: Public Health Wales, Swansea University, 2019
In the study, the youngest of the 33 cases reviewed was 13 years old and 70% were male.
Seventy per cent had experienced at least one ACE. Some of the issues in the background included: substance misuse; poverty – more than half lived in an area classified as deprived; sexual abuse and assault; bereavement; shame; difficulties in education, employment or training; and lack of awareness around self-harm.
Six of the children had expressed their distress on social media beforehand; five had a family history of suicide or suicidal behaviour.
Eight had recently experienced a relationship break-up, while six had experienced issues with attendance at school and truancy.
The review notes there is rarely a single reason why a child or young person takes his or her own life. It's usually due to a variety of risk factors, circumstances and adverse experiences, which the children's commissioner – in her introduction to the report – calls "complex".
Despite this, suicide is potentially preventable.
"A number of young people had episodes of self-harm where parents were unsure of how to respond and so were not accessing services even when this was suggested by schools or healthcare services," the study said.
"Stigma related to self-harming behaviours remains a major challenge to suicide prevention efforts."
'I don't think he wanted to die – I just don't think he wanted to live like that any more'
Josh Merrells was found dead in woodland near his home in Gowerton near Swansea on 6 August. He was 15.
"He struggled in school academically because he was dyslexic – and because of that he found his creativity," she said.
He also had struggles with bullying, had lost someone close to him through suicide last year, and came out as gay.
"We knew Josh was gay before he knew – and embraced it and fully accepted it," said father Michael.
His mother said: "There were a lot of factors, not just one
Michael said: "He admitted he'd tried several times to end it – various methods – and laughed it off, nonchalant. You speak to him, he's normal, happy. In fact, the last weekend, he was the most bubbly and charismatic we'd every seen him."
On the evening Josh died, he left food in the fridge to eat later and went to a friend's home.
"I don't think he wanted to die – I just don't think he wanted to live like that any more."
An inquest will look at the circumstances around his death.
Michael said: "There's too much of a rush to try to label these kids, focus on the condition and not the individual. I discussed this with Josh and he felt that he would give them the answers they needed so they'd leave him alone.
"We begged on occasions – he's going to do this, he's only got to get it right once. The question was constantly raised – 'you don't feel like that now, do you?' And he'd go, 'no, no, of course I don't'. So 'Ok, there you are.' Tick, gone."
What needs to happen?
Review leader Prof Ann John, national lead for suicide and self-harm prevention at Public Health Wales, said suicide was not inevitable and the review offered a framework for tackling some of the issues leading to it.
"We need to be tackling issues such as alcohol and substance misuse in young people and making sure young people who are abused, sexually assaulted or bereaved are able to access the talking therapies that we know can support them," she said.
Lynne Neagle AM, who chairs the Welsh assembly's cross party group on suicide prevention, said the review was the "closest thing we have to hearing the voices of those young people who have died by suicide".
"Nothing is more important than preventing young people dying by suicide," she said. "I believe it is nothing short of a public health emergency."
She said the clear opportunities for suicide prevention needed to be seized with "vigour, determination and urgency".
'Compulsory' mental health education call to tackle suicide in Wales
'Reach out' plea to prevent suicide in Wales
Male suicide rates in Wales 'a national emergency'
'More can be done' to prevent student suicide in Wales
Kate Heneghan, head of the suicide prevention charity Papyrus, in Wales, said it believed "talking about suicide is the only way to challenge stigma and we know that talking openly encourages young people struggling with thoughts of suicide to seek help".
"By asking 'are you having thoughts of suicide?' you have conveyed that you are a safe person to talk to and will help them to seek help."
She added: "What really struck a chord was reading about the number of young people included in the report who had episodes of self-harm where parents were unsure how to respond.
"All too often at Papyrus we hear from bereaved parents who say they felt lost, they didn't know what to do or where to turn and wished they had known about our helpline service when they were struggling to keep their child safe."
Prof Sally Holland, Wales' children's commissioner added: "I am passionate about pushing for earlier and more joined up support for children's mental health and social care needs. This review provides stark evidence of the importance of the need for these changes in Welsh communities."(She has not responded to several e mails re the issue of anti depressants)
Six key suicide prevention opportunities:
Ongoing action to restrict the access of children and young people to alcohol, along with full implementation of guidance to prevent substance misuse.
Continued interventions for children who have experienced ACEs. This should also include greater engagement with safeguarding boards to raise awareness of the importance of protecting children from the effects of domestic violence and sexual abuse.
Management of self-harm.
Raising the age of participation in education, employment or training, including looking at support mechanisms for 16 to 18-year-olds.
Better information sharing, including with private schools and state services.
Better knowledge and awareness of self-harm and other risk factors for suicide
Can you please let me know what actions are being taken in Wales??
Not holding my breath for a response of course – but if and when the shit hits the fan there is loads of evidence that they collectively contributed to the deaths of children by ignoring the potential adverse effects of anti depressants