The Banality of Health Service Evil

Print Friendly, PDF & Email
January 9, 2020 | 39 Comments


  1. After reading this article, I want to write so much however, I am left speechless.
    What has really changed since Nazi Concentration Camps?
    Some of us, if we catch the wrong train, are still human guinea pigs being experimented on however, it is so subtle that one cannot notice things for what they truly are?
    For those who have never experienced what we endured, you have no right to judge us!
    If you have never experienced pain or suffering , which goes beyond ones ‘pain threshold’ from a medicine(s) that are perceived as beneficial, it is best to refrain from speaking.
    I am very disappointed, to say the least, how I and many innocent people have been maltreated especially, when we did not understand what was happening to our good health however, putting everything aside, I am blessed (I am sure that many are not as privileged, as I am), to be alive.
    For those who displayed so much humility, even if it was a kind word, it gave us the courage to soldier on, although at the time, it was indeed, very unbearable.
    How I and others came this far, is beyond my comprehension however, many of us have decided to put it behind us (the best way we know how) and get on with helping others see what we have learnt from this journey called ‘life’, which is an experience, that no one will have to go through, if the necessary changes take place.
    Perhaps, all can learn from their mistakes (including myself) and pave a positive legacy for future generations, to come…………..

    • Hi Carla There are many mistakes i’ve learned but re your comment about being experimented on – for sure especially perhaps but not only, referrals to ‘prestigious’ ‘world renowned’ hospitals have taken advantage of the lack of knowledge and of the trust people put in clinicians. At one major Trust in London groups of doctors had /have an interest in psychosomatic medicine. I was one of those who got caught up in that by without knowing what the clinician ‘s interest was, by being referred by a GP who had contacts/friends/relatives in the field of therapy and all needed referals to gain funding. It was confusing and frightning to find what I was describing was being ignored and the responses were being dealt with as psychological asI became more and more ill and lost my job.. After a long kafkaesque period I insisted on seeing a specialist , The GP
      was furious but I immediately went through a serious operation. There was never any apology, forget sympathy just anger that they had been found out. Obviousy I had to make major changes including by moving out of the area as they had networks which made itimpossible to register with another practice. Although a GP in another practice who had heard what had gone on offered to register me with her. Lessons learned include – for me but not many will be so extreme, don’t go near doctors at all, (there have been other consequences on my health),, trust my intuition, I thought maybe it was some prejudice that I didn’t like or trust the GP so gave it too long , should have moved sooner, always read medical notes , mine were full of dishonest entries such as having received therapy, I hadn’t ,and these days it is much easier to get some background info about them on the net. It can still go on though when so many people can be chanelled to doctors who practice therapies (or any other interest group) or end up with GPs who are obssessed with psychology. The GP.s wife eventually left her job at a centre where funding was dependant on GPs referrals ,including from his practice and she practices privately as do many of the cohort who were trained at that hospital using naive clients as training and so called ‘research’ fodder. The lessons they learned were forced on them as I wouldn’t shut up afterwards but they changed not as a matter of decency or morality . Also that the ‘research’ is not verified and relies on publications without evidence to properly support theories being promoted – and practiced on clients. Just a reminder to clients who haven’t been told – there is a right to therapists’ files even though one well known practitioner advises trainees and others that they should be given only if requested. Playing on necessary ignorance intead of openly informing people before they begin a course of therapy at all that they have a right to know what is being recorded – and shared between GPs. Importantly make Advanced Decisions – I used to circulate these – a good free form is produced by Dignity in Dying but they are not just about dying they include decisons made about other health issues to be followed by medics and others and are pretty much binding, with some exceptions. , One last unsavourary note for now. Another ‘top dog’ therapist/analyst , furious at having been told he and his friends could no longer publish without consent of clients, suggested they might publish their books under pseudonyms to make it less likely that clients would read and recognise themselves – and take legal action as therapy is still not included under regulation covering ‘other professionals’ They have their own codes – and are still laughing about that These are often presented as on the compassionate people centred end of services … ever some are but it can’t be taken for granted.

  2. David, from an experimental perspective, if some researchers and drug manufacturers get away with harming people, of course this futile ‘carry on’ will continue.
    As for some people who make lots of money from prescribing and manufacturing, rogue medicines, it totally makes me question the principles of ones actions.
    Yes, if there are no fines or infrastructures put in place to STOP corruption, what are innocent people like you and I meant to do?

    • The experiments show its not some people – its almost everyone who co-operates with the system. All the bureaucrats and managers and middle managers – everyone.

      We all get on the train figuring someone somewhere will spot a mistake has been made. They don’t.


      • If no one within the system is likely to raise their head above the parapet and try to bring about the needed changes, we need to target certain people or organisations that are capable of making the changes, and find a way of forcing the change.

        Asking them politely to change because the overwhelming supporting evidence shows these drugs are causing harm so far hasn’t worked; they always seem to find some way to wriggle out of making any real change.

        We need to somehow get the hard evidence that cant be argued with, and then find a way of forcing the change.

        As the American Feminist Gloria Steinem said; “Power can be taken, not given. The process of the taking is empowerment in itself”

  3. There’s a lot of work to be done. Teaching pharmacovigilant practice is my passion. So deprescribing, educating patients about meds ADRs risk vs benefit all so important. I go so far as to list all black box warnings & serious SEs for meds on discharge instructions, review with patients and encourage my colleagues to do the same. I speak as a clinician and also someone harmed from medications. I’ve worn the shoe. It sucked, still sucks (have cold dysthesia in face right now and tingling in feet – could have died thankful I didn’t) and I feel a personal responsibility to teach educate and protect my patients. One major concern is the misrepresentation of trial data and big pharmas control over meds. I don’t prescribe anything new to anyone unless it’s to save their life. 7 year rule at least. I educate my colleagues -Drs. nurses PA NP alike about what reality is with medications and that less is more. I’ve a bit of a reputation as a med Nazi. I honestly don’t know how doctors ever let big pharma take over but unfortunately money prestige apparently talks. The system in so many ways is fundamentally flawed. Psychiatrists are the worst for underestimating harms of their meds and they seem to know the least about them yet prescribe them by the boat load. They hardly ever recognize drug to drug interactions. They worry about teaching people about a prolonged QT interval (saw this by a psychiatrist on Twitter earlier) instead of things we more commonly encounter. While that’s important, they don’t recognize the stuff that happens all the time or they minimize it – benzo and AD withdrawal, TD akathisia and horrible weight gain metabolic syndrome caused by atypical AP etc etc. and then there is the cascade prescribing of meds for symptoms caused by other meds. Then they make a patient the diagnosis in the DSM and believe in the myth that pharm created. The myth is now reality. I almost fell over when I read that Bipolar II (which imo shouldn’t even exist as a diagnosis) was placed in the DSM to prevent AD prescribing to those patients for fear of induction of mania. This is taken verbatim from a leading doc who created DSM V. Saw it posted on his twitter account. I’m still shaking my head at this because that IS insanity. But while I have complete disrespect for those who causally prescribe I hold more anger and lay more responsibility for the mess we’re in with those high up in big pharma Drs and executives whose bottom line is their bankroll. People like Nemeroff and those who think ghostwriting isn’t such a big deal. Everyone needs a Dr. eventually. Therein lies the rub.

    • Jayme,

      Perhaps you could read through this paper, produced by the UK Royal College of Psychiatrists relating to ‘Personality Disorder’.

      I would welcome your views as to its ‘established authenticity’ as a disorder, and if you think that they are going the right way about ‘educating psychiatrists’ and others in the recognition of this ‘disorder’ ?

      Thanks, great comment, btw

      • Hi Annie,

        I’m not a psychiatrist or a psychologist so not trained to that regard. My comment regarding Bipolar II is informed by reading on the topic including David’s book on Manic Depression, the epidemiology & consequence of that actual disease and it’s morph into Bipolar Disorder with the expansion of that diagnosis in the 90s in the advent of mood stabilizers etc etc. propagated by big pharma. I will read the article and happy to share my unprofessional opinion. Having the power to label is a scary thing imo because it reduces a person to a diagnosis. Depending on who is doing the labeling, creating the “disease” people’s lives are inextricably altered. Again in someone who has absolute mania, perhaps lithium or an antipsychotic benzo brings relief so not denying labels drugs not valuable in some settings. These are much more exceptional cases than most of those who’ve been diagnosed Bipolar. Seems like everyone has a touch of some “mental illness” today that needs a pill. John Nash (diagnosed schizophrenic) did quite ok eventually without meds. Nearly killed by insulin shock treatment given by “experts” with the power to label diagnose.

      • Just breezed through the personality disorder guidelines. I don’t really get how labeling a person with a personality disorder is at all helpful in solving their issues if they want them to be solved. Seems a bit rudimentary and this labeling seems to miss the complexity of people’s motivations. I used to date a guy whose brother had Tourette’s. First date we had a double date with his brother and his wife. Matt, his brother, was having some tics and obviously had Tourette’s. So we had a good time dinner and as we were walking to the car I said hey you didn’t tell me your brother had Tourette’s. So interestingly Matt had never been officially diagnosed and well good for him. He functioned just fine and made a living and had a good life. His family accepted him as he was and never acted like he was ill & this is what he learned that he was ok. I’m weary of labels.

        • Unfortunately, in mental health terms, a ‘personality disorder’ tends to be a ‘get out clause’ – faulty patient, learn to live with it.
          Labels serve one purpose only in my opinion – better understanding; never to be used as an excuse for unacceptable behaviours – by patient nor physician!

  4. ‘everyone needs a Dr. eventually. Therein lies the rub.’ These words of Jayme’s hit the nail firmly on the head. It’s not fashionable to say what I’m going to offer as a reason, and I’m nervous to do it, but people only do things they should, according to conscience, when they FEAR not doing so. ‘Their bottom line in their bankroll’. Absolutely, Most people’s bottom line is their bankroll. In the olden days there was primitive religion and the fear of hell if we did wrong. Of course, different religious types’ views on what was ‘wrong’ could be, and was manipulated, to fit more bankrolls etc.

    The Nazis, I was told, by some of those who lived in Germany in the War, made you do what they wanted because otherwise you might be killed yourself. So, fear of death was the reason to abandon common sense and do whatever you had to, to conform to the regime, to stay alive.

    Fear of death is what makes people venerate doctors. Doctors offer us ways of staying alive. Except it’s going the wrong way all the time, and many of them, by doling out the Guidelined poisons, are instead killing us horribly, and maybe unsuspectingly, in droves. Because the crusader Knights out there, have all been put into a kind of magician’s stupor by a Pharma Merlin.

    We shouldn’t be so afraid of death. I don’t mean, in the regulated religious sense. But I mean, if we believe in SOMETHING other than manmade science, it’s quite amazing what miraculous things can occur. There is, I am certain, some divine form of intelligence out there. Those of us who’ve lost loved ones to medical poisons badly used, can assure you that death absolutely isn’t the end. Many of them communicate with us, they have an overview.. (I know many reading this will assume this is ridiculous, I take a risk even daring to mention it).

    My firm belief is this. We are only here to learn. We have choices. We won’t be going to an old fashioned kind of hell if we don’t learn, but we even so, we haven’t really got the knowledge to understand what this life is all about yet. Except it’s surely a battle between the good we can do and the possible evil. So, I don’t think you can appeal to consciences generally unless people think there will be punishment, and if they believe that ‘when you are dead you are dead’ and that there’s no retribution of any intelligent kind at all, then whatever they can get away with in this life, remembering the bankrolls, most of them will. They are in for one hell of a surprise….

    • My god Heather your comment blew me away because I believe exactly what you do.

      I would like to tell you when my father died suddenly, the night before I woke up in the middle of the night sat up in my bed and saw a young man that I knew and loved in a bright light staring down at me with love pouring out from him that wrapped around me like a warm blanket. I reached out to touch his face to see if he was real. He then looked up as if to be looking at someone else (maybe his guardian angle) looked back down at me one last time then disappeared. I then fell back down on my bed as if still in a deep sleep, my body feeling very heavy then woke up properly to wonder what that was all about. I eventually went back off to sleep. The following day I found out my father had been found dead at home. I knew then that was my dad coming to say goodbye.

      Heather I too believe there is something divine out there that we cannot explain, I also believe we are here to learn. Maybe as you say we will all find out one day when our time comes.

      It saddens and angers me that there are so many uncaring people in the world but especially when it comes to governments and departments that are supposed to be there for our well being that are doing us more harm than good.

      I worked in the NHS for nearly 20 years and I can honestly say it not only matured me as a human being it taught me just how precious life is. Every single human being is unique and is just as important as the next person.

      I don’t understand why so many medical people in positions of power think otherwise that profit should come before life. I really just don’t get it, they have no moral conscious at all.

  5. Heather, we are all programmed to believe everything we hear and read.
    What if life is eternal and we never die?
    I love this quote by Albert Einstein:

    Education is not the learning
    of facts, but the training
    of the mind to think.

    When I challenge myself to think outside the box, it is quite extraordinary how I never stop learning.
    Is experience one of my best teachers?
    Without experience, whether positive or negative, how can one impart invaluable knowledge to another?
    Perhaps that ‘spark of knowledge’ frightens many because we shatter their whole perceptions of what they have been programmed to believe.
    If we don’t fit the mould, (whatever this may be), many will denigrate us for an experience that goes beyond their beliefs.
    Many times, I sit back in awe and am fascinated how knowledge is imparted?
    All I know is that there is an omnipresent divine being, far greater than one can ever imagine, whom is all seeing and knowing. This is an education that does not come from learning.
    It comes from the divine.

  6. Annie, I’ve tried to read the paper you’ve asked Jayme to comment on, on Personality Disorder. I’m totally confused, drowning, in fact. I just don’t ‘get’ what this whole Personality Disorder thing is about. Aren’t we just pulling every little bit of ‘unstable’ behaviour down to the lowest common denominator and lumping it all together, into some kind of druggable disease?

    As to manic depression morphing into bi-polar, isn’t that just another example of the same. Anyone who has been in close contact over a long period of time with a genuine manic dresssively-afflicted person, will know the true extremes of their behaviour, the bizarre situations they find themselves, and land others, in. The horror and terror of trying to reason with someone who is REALLY manic, in the old sense of the word. When their brain seems to be firing brilliantly at ten times the speed of yours, when every argument you put up is defeated with their logic which actually stops you in your tracks and has you eventually privately questioning your own sanity. And then the long periods of deep static depression when all the havoc the person created seems to have been forgotten by them as they gaze blankly into space, for weeks on end. THIS is manic depression.

    Bi-polar* is not this. Manic depression**, of the real variety, i understand, is rare, thank goodness. ‘Bi-polar’ seems to afflict a high proportion of the population. It’s like comparing flu* with pneumonia**. And therefore, by the same token, isn’t Personality Disorder simply a label stuck on anyone who has had the temerity to be a bit tricky to get along with? But we have to find a reason for everything, diagnose and ‘fix’ it. Is this because some of us feel a desperate need to analyse everything that crosses our radar, put it in a box and write a label on it, so that we feel we are in control?

    Is this what our leisure time has brought us, this wonderful gift of leisure we were told was coming in the 1950s, when life would be easier, when inventions to take the grind out of our lives would free us up to do wonderful things with our free time. Is this where we’ve ended up, dosed up on loads of pills and feeling unsatisfied with life so we need to be labelled and boxed. How sad is this..

    • Excellent post Heather. I love ❤️ that “a little bit tricky to get along with”. Yep not a disorder just maybe not folks you’d want to keep company with all the time.

      • Or, even worse, just someone who is damaged by the medication supplied to them and therefore doesn’t fit any of the tick boxes – after numerous attempts to label, without success,slap a ‘personality disorder’ label on them and carry on drugging. It happened to Shane for 15 years!

    • Terribly sad Heather In a small village I used to live a young lady had been given the job of traffic warden – she stopped the traffic at the zebra so children could cross the road to school. She was treated with utmost respect and was paid for her job. The children saw her as another adult in charge and looking after them. These days she would be labelled as ‘autistic’ and no doubt channeled into some scheme/project where her talents would never be recocognised . But some group would get funded. A group in Manchester Uni is currently investigating the failures of the social programmes now being promoted as high numbers of people referred to them either dont take up the ‘offer’ thanks very much or drop out. The funds given to them amount to several million which a spokesperson from Manchester says are being wasted. So often these projects are set up, then they need yet more groups to research them, then they need more people to experiment on, then the groups are tweaked then another thing becomes the plaything of ‘professional;s, ad infinitum….How many should be screaming ‘leave us alone;! given the freedom from interference so many could avoid any offensive labels hung on them.

    • New health secretary pledges £4.5m towards GP social prescribing
      23 Jul 2018

      GP practice social prescribing scheme receives £3m lottery grant
      20 Jun 2018

      GP practice-based financial advisers secure extra £850k in patient benefits
      02 Oct 2017

      GP workload to be tackled with £130k social prescribing scheme
      13 Apr 2017

      Hundreds of thousands ploughed into GP social prescribing schemes
      06 Feb 2017

      GP social prescribing can reduce appointments ‘by over one fifth

      GP practices could receive £1 per patient to fund social prescribing adviso
      A social experiment: How GPs will ease the care crisis

      Social prescribing scheme ‘did not cut GP workload or improve patients’ health’
      08 Aug 2016

      New £30m development programme ‘will free up 10% of GP time’

      The Government’s drive to get GP practices to refer patients for help with social problems like housing and loneliness is not supported by research evidence and is an ‘unacceptable’ use of precious NHS resources, health policy experts have warned.

      Researchers said their systematic review of such schemes showed the evidence base was ‘a mess’, with biased reports being used to promote the agenda on social prescribing.

      Social prescribing programmes involve a range of models whereby GPs can refer patients – usually to a linkworker employed by the practice or a local group of practices – for help with non-medical problems, such as chronic loneliness or finance and housing issues.

      We need less rhetoric and more reality on social prescribing
      Several CCGs across England are rolling out such programmes with encouragement from NHS England, which promoted the programmes in the GP Forward View after they received the backing of health secretary Jeremy Hunt. NICE has also endorsed the approach, calling for GPs to refer vulnerable people to singing, dancing and art classes.

      The systematic review, carried out by researchers based in York, Leeds and Manchester, and published in BMJ Open, looked at UK studies of such programmes that were published between 2009 and 2016.

      The investigators identified 15 eligible studies in which patients were referred to a range of interventions such as exercise, housing and welfare advice, adult education, befriending, counselling, self-help groups, luncheon clubs and art activities.

      They found none of the studies could be trusted because they were highly likely to be biased from the outset, while most were small scale and poorly designed and reported.

      Yet, ‘despite clear methodological shortcomings, most evaluations presented positive conclusions’, the authors wrote.

      They concluded: ‘Social prescribing is being widely advocated and implemented but current evidence fails to provide sufficient detail to judge either success or value for money.

      ’If social prescribing is to realise its potential, future evaluations must be comparative by design and nconsider when, by whom, for whom, how well and at what cost.’

      Co-author Paul Wilson, a senior research fellow at the University of Manchester, told Pulse: ‘The reality of the evidence base for social prescribing is it is a mess. As such, we are not yet able to reliably judge which, if any, social prescribing programmes are worth pursuing further and or what the added value may be to existing services.’

      He added that ‘in the current financially constrained climate this is unacceptable’.

      ‘New ideas and ways of working are not without cost or consequences. They compete with existing services for finite resources,’ Dr Wilson said.

      It comes as NHS England’s appointed lead on social prescribing has called for every practice to be given £1 per patient to fund such schemes, and Pulse has revealed that several CCGs are already investing heavily in the programmes, although large-scale evaluations are yet to report their outcomes.

      NHS England was approached for comment but had not responded at the time of publication.

  7. Some disorders are concocted by those who do not want to have the TRUTH exposed.
    I am sure they have a label for being TOO HONEST.
    Like someone mentioned, they will use any excuse to dish out a pill for anything!
    There have been some who have warned me that if I write a book, it will not be published???
    Suzanne and Heather, there are so many people who have been unjustly treated and they will do everything to discredit ones good name!
    I believe in natural justice ~ There is nothing more to say.
    I feel pity for those who ruin peoples lives because of their wretched DISHONESTY.

    • Could you use the pseudoanonymised trick Carla. It’s what medics are allowed to do when publishing confidential information as ‘case histories’. I’m sure you’d sell millions!

  8. ‘Drowning’ is just the right word, Heather

    Drowned-out, is another…

    Over the last few years, the UK Royal College of Psychiatrists has been drowning, largely from groups of unqualified non-experts, a sea of amateurs, spilling out more and more non-evidenced information to largely an uninformed public.

    Why not push on with a push for further non-evidenced disorders, as the ones they have been pushing have seemingly reached saturation point, in their eyes?

    Quite why Dr. Adrian James put his name to this latest ‘directive’ – a heavyweight, an expert in all things psychiatrical, practising for his new world order …

    When even the ex President, soon to be ex ex, looks it all over, looks over their shoulders like a mother hen over her brood; it is all very incestuous …

    This was all pretty shocking :-

    Three good comments from Marion, Peter and Fiona


    This is an expert view of Bi-polar which I thought you might like to listen to.

    History of Psychiatry

    Podscast Series

    Bipolar disorder is a complex psychiatric disorder of mood and behaviour that has been recognised for thousands of years. It probably affects about 1 in 50 individuals worldwide and is characterised by episodes of depression alternating with episodes of mania. In this podcast we discuss the presentation, diagnosis and treatment of bipolar disorder. We highlight the strengths and limitations of current diagnostic classifications and we consider the need for a multidisciplinary treatment approach that integrates medications (such as lithium) with psychosocial approaches (such as group psychoeducation). We also consider the intriguing link between bipolar disorder and creativity and we conclude with an optimistic discussion of latest research in the field and how this will ultimately lead to improved diagnosis and new treatments in the future.

    Stephen Fry

    Bi-polar light …

  9. Wendy B recommends taking up knitting. And maybe Adrian who has been/is until he gets his gold badge , the media prefect for the coll of psychs has been giving her tips on how to get the message across by telling a lovely human story .We could all do it – eg – only last week I walked in and found my friend collapsed on the floor – her husband had hanged himself because the drugs he had been forced to take as part of ‘care in the community’ had led him to the despair of committing suicide’. Add that to your store of stories Wendy

    Wendy Burn: There is a long way to go to securing the mental health workforce that we need
    In The BMJ January 10, 2020
    A workforce crisis has left mental health staff at “breaking point.” Wendy Burn discusses what can be done to recruit more doctors into the specialty

    A stitch in time saves nine. Prevention is better than cure. You’ve heard it before, but who can argue with this?

    Sadly, many people seeking support for mental illness, like Jane, who told us that she needed to wait 12 weeks to see a psychiatrist, are not able to benefit from this wisdom. During this time, she became more and more unwell, and eventually was detained under the Mental Health Act to an inpatient ward.

    Due to shortages of permanent staff, during one hospital stay, Jane ended up receiving care from three different locum psychiatrists. Frustratingly, each doctor changed the way that she was cared for and Jane’s depression continued to deteriorate.

    Experiences like this are highlighted in the BMA’s mental health workforce report which finds 63% of mental health professionals surveyed have rota gaps across their team, and almost half of doctors said that there was a shortage of at least one medical staff member during their last shift.

    These figures chime with the early findings of RCPsych’s latest census (published in December 2019) which found one in 10 consultant psychiatric roles are unfilled. I’m worried that there will be many more people like Jane across the country left waiting too long to get help, and that workforce shortages are affecting clinicians’ workload, wellbeing, and morale.

    Progress has been made in recent years with an increase of more than a third in trainees taking up core training in psychiatry in England between 2017 and 2019 following the success of our #ChoosePsychiatry campaign, as recognised by the BMA.

    Despite this our census finds that the vacancy rate for consultant psychiatrists has doubled in the last six years. In addition, between March 2017 and March 2019 only 120 consultant psychiatrists have been added to the NHS workforce which means 450 still need to be recruited to meet HEE’s mental health workforce targets by 2021. Upsettingly, areas prioritised for investment including eating disorders, child and adolescent mental health services, and perinatal services have particularly high vacancy rates.

    There is clearly a long way to go to securing the mental health workforce needed. I fully support ambitious plans set out by NHS England last year to improve mental health care. They build upon significant investment already made, which is increasing access to many specialist services. But in the bluntest terms—without people in place to deliver improved and expanded services, the plans will fail.

    I do not want the people who stand in line to be helped by these plans, to be let down.

    Immediate action is needed to make practical changes like providing computers that are ready to use within a few minutes, places to sleep after night shifts and buildings that are safe for patients and that we are not ashamed of. The pension crisis is still not fully solved and yesterday I heard of another person leaving the workforce due to this. These things might seem basic, but I assure you they are essential to keep existing people in the NHS. Improving staff wellbeing and morale will also be key: at RCPsych we are developing standards for a wellbeing section to be included in psychiatrists’ job descriptions.

    In terms of having the people to deliver services, looking closest to home is best. The BMA identifies the ongoing practice of sending patients out of area for treatment as a major challenge in mental health services. New figures out this week find that 675 patients at the end of October 2019 were receiving treatment far from home. This is a reduction from previous months which I am very pleased to see but there is further to go—out of area placement should be a Never Event. Not only is this extremely detrimental for patients, but it also adds extra strain on staff who are required to make what can seem like futile attempts to find their patient a bed. They may also be left with the terrible dilemma of a patient who is willing to accept a local bed but who refuses to go to a hospital miles from their home and who then might require detention under the Mental Health Act to keep them safe.

    Independent research commissioned by RCPsych identified 13 areas experiencing significant struggles with sending patients out of area to receive care or with extremely high levels of bed occupancy and showed that more mental health beds are needed. RCPsych is calling for additional beds across these areas, aligned with workforce and service delivery plans so they are properly staffed and resourced.

    Looking to the future, the road from applying to medical school to helping patients as a fully trained psychiatrist is long. To meet demands across the NHS and guarantee adequate supply of doctors to help people with mental illness, the government must double the number of medical school places in the next decade.

    What is then important is that a good chunk of these medical students opt to pursue psychiatry. Without the stigma of previous generations, more and more young people are interested in helping others with their mental health. We must tap into this interest.

    As the BMA recommends, it is crucial that all medical students get a better understanding of mental illness and psychiatry. RCPsych found that students’ experience at medical school has a huge impact on the specialisms they choose to work in, particularly the content of courses taught to students and the quality of their placements.

    In order to achieve parity of esteem between mental and physical health, we need any new medical school places to be allocated to medical schools with concrete plans to raise students’ interests in shortage specialties, like psychiatry. RCPsych has developed guidance to help medical schools develop such plans. They should include giving students access to high quality placements in mental health services and revising curricula so that psychiatry is brought into courses consistently—led by psychiatrists and as early as possible—rather than as an obscure add-on.

    I want people to choose psychiatry and choose to listen, to see possibility and to make a difference. To give an example from my own experience—can you imagine how it feels to watch your elderly patient start (and hold down) a job as a result of having finally received support for a psychotic illness which had left her unable to work for forty years?

    It’s incredibly uplifting. Yet too many others are not half as lucky. This is exactly why a stitch in time is needed now, to secure the mental health workforce and to secure the mental health of future generations.

    Wendy Burn, President of the Royal College of Psychiatrists and a consultant old age psychiatrist.

    Competing interests: None declared

  10. Gabapentinoids: has reclassification really solved the problem?
    BMJ 2020; 368 doi: (Published 13 January 2020)

    Reclassifying pregabalin and gabapentin only moves the problem onto other drugs

    Related content
    Elisabeth Mahase
    Author affiliations
    The government’s reclassification was expected to reduce prescribing of gabapentinoids, but Elisabeth Mahase finds that a lack of support for GPs and patients is limiting its impact
    In October 2018, the UK government announced that it would be reclassifying gabapentin and pregabalin1—known collectively as gabapentinoids—after experts pointed out the rising numbers of deaths linked to the drugs.

    Gabapentinoids—which are indicated for the treatment of epilepsy, peripheral and neuropathic pain, and generalised anxiety disorder in adults—were officially reclassified as class C controlled substances in April 2019. Reclassification has made it illegal to supply pregabalin and gabapentin through repeat dispensing, and pharmacists now need to dispense the drugs within 28 days of a prescription being written. Doctors must also hand sign prescriptions.2

    In the UK, the rate of patients newly treated with gabapentinoids in primary care tripled between 2007 and 2017, according to research published in JAMA.3 By 2017, 50% of gabapentinoid prescriptions were for an off-label indication and 20% had a co-prescription for opioids.

    The numbers of prescriptions are rising

    In 2015 Risk .org published 209 responses to this editorial by Johanna Ryan
    About Us
    Complex Withdrawal
    Drug Checklist
    Guides & Papers
    Drug Interaction Checker
    Post-SSRI Sexual Dysfunction
    RxISK Map
    Too Many Drugs?
    Kicking Lyrica
    Print Friendly, PDF & Email
    August 24, 2015 | 209 Comments
    Editorial Note: This post was put together by Johanna Ryan from reports to RxISK on Lyrica – Pregabalin. Lyrica is closely related to Neurontin. Many anticonvulsants such as carbamazepine have been used for forty years for pain syndromes such as trigeminal neuralgia. Neurontin but especially Lyrica have been promoted heavily for this. Both cause dependence and withdrawal and because pain and burning sensations are such a feature of withdrawal, they can both become the problem they are used to treat.

    Burning feet

    Please describe the side effect, and its impact, in as much detail as you can
    Memory prob:

    I developed really bad constipation. My skin started peeling on my hands. I packed on about 20 pounds in two months with no change in my diet or exercise. I’m a high school teacher and had trouble remembering the names of my students. I had significant problems learning new material that I needed to teach. I felt like my emotions were completely shut off. Looking back on it, I turned into a brain dead zombie.

    Did you continue taking the drug? Why or why not?

    NO: “The side effects while taking Lyrica were intolerable. I was a brain dead zombie but didn’t realize how bad things were until I was completely off the stuff and was able to reflect back on how I was when taking the stuff.The withdrawal was absolute hell. I tapered in 20 mg doses (the smallest available dose) over the course of about 4 months. I experienced agitation, skin crawling, major depression (I spent most of the summer in bed), panic attacks, and became severely suicidal. About a month after my last dose, in the space of maybe a day, I felt like I had walked out from under a dark cloud that I had lived under for two years (I took gabapentin before switching to Lyrica). I could feel emotions again, the depression lifted, the suicidal thoughts disappeared, and, I could think again! My neuropathy flared up badly as I decreased my dosage but it settled down after a few months (with the help of Lidoderm patches and a B-vitamin/ alpha lipoic acid supplement) and I found that the pain I was left with was way better than the side effects from Lyrica.”
    What advice would you give to someone who was considering taking this drug?

    “Lyrica does work for neuropathic pain but, in my experience, there are far better solutions for neuropathy. The side effects while taking it are terrible, you won’t know how badly the stuff affects you until after you get off of it, and the withdrawal is absolute hell. If you need to take a prescription neuropathy drug, take gabapentin at the lowest dose you can manage since the side effects aren’t as severe nor is the withdrawal as bad.Here is what I wish I would have known when I first started dealing with severe neuropathy:
    If you are experiencing localized neuropathic pain, stabbing or burning in spots that you can point to, use prescription Lidoderm patches on those spots every day for several days. It may take a couple of days but it’ll work wonders. My localized neuropathy was horrifying, 100 (no, I’m not exaggerating!) on the 1-10 pain scale, and when I finally tried it, Lidoderm patches made it completely disappear within about 6 weeks.
    For the more diffuse pins and needles type of neuropathy that spreads over an entire limb, try a B vitamin and alpha lipoic acid supplement. There are several published medical studies that show that this works. I take a supplement that I order online called Neuropathic Support Formula. I really didn’t have much hope for it but I was desperate and finally decided to try it. About an hour after my first dose, I was surprised to notice that the constant pins and needles had diminished. I take it twice a day, I experience no side effects, and after a few months, I barely notice the pins and needles anymore. If I forget to take it for more than a day, I notice an increase in pain.

    If the Lidoderm and B vitamin/ alpha lipoic acid isn’t enough then try gabapentin (not Lyrica). If you’re thinking about increasing your dose, test out if you will experience withdrawal when you want to get off the stuff. On one of your doses, take one capsule less than you usually do. You’ll know in about 5-6 hours how bad the withdrawal is for you. Some people have no problems with decreasing the dose while others, like myself, experience significant withdrawal (racing heart, skin crawling, agitation, etc.). It’s good to know what you’re facing so you can weigh the advantage of less pain if you increase your dosage vs a longer withdrawal period when it’s time to get off the stuff.

    I had neuropathic pain from a broken pelvis I got from a major bike accident and from Cauda Equina Syndrome as a result of a failed back surgery. I took gabapentin for a long time and kept increasing the dose and then switched to Lyrica on the advice of a pain management doctor. I’ve since discovered that all my doctors except one have no idea about the potential severe side effects and withdrawal problems with both gabapentin and Lyrica. None of them had me try Lidoderm patches for severe localized neuropathy (my physical therapist told me about it) and none of them know about B vitamins and alpha lipoic acid.

    So, my doctors had things completely backwards. Instead of starting me on treatments with no side effects or withdrawal risk (Lidoderm patches and B vitamins/ alpha lipoic acid) and then adding gabapentin as needed, they started me on gabapentin, kept increasing the dosage until I was at the maximum and then switched me to the even worse Lyrica. I figured out the much better solution on my own and of course, went through the hell of Lyrica withdrawal on my own with no support from any of them. I’m not sure if they really believed me when I told them how bad the side effects of Lyrica and Lyrica withdrawal was.

    If you are already taking Lyrica and want to taper off, ask your doctor for a dose equivalent prescription for gabapentin since it’s significantly easier to taper off of then Lyrica. I figured this out towards the very end of my Lyrica taper and it made my last couple of tapers much easier.”

    There is a Lyrica Survivors group that is very active on Facebook. It is a closed group so you will have to ask to join the group. There are currently over 1300 members from all over the world. It’s a great place to ask questions and find support if you are struggling with the side effects and/or withdrawal from Lyrica.

  11. This gets at the very nub, of ‘Suicide Prevention Strategies’ …

    AC 17 hours ago Reply

    Peter Gordon to me and many others you are an absolute fearless ‘Hero’ Anyone that swims against the tide is ‘Punished’ look at what happened to Professor Goetche, Professor Healy, You… Professor Healys Blogs are always worth looking at.. You are quoted frequently there. DH talks about Knights… Not ‘Sirs’ Not sure who will be ‘King Arthur’ but there are many Knights and Knightesess… Your patients will be the poorer for not having you as their Dr…. As to activism if it helps your mental Health do it, if not don’t… Or take a break…. People like Michael Hencher, Bob Fiddaman, Marion Brown, Terry Lynch, Lucy Johnson, Mark Horowitz all are fellow Knights… Take care and God bless you and your family Peter….

    Jan 15, 2020

    A timeline of missed opportunities

    This film presents a timeline from 2002 to 2019 in relation to England’s National Suicide Prevention Strategy.

    The film presents missed opportunities, in particular the potential role of prescribed medications as risk factors for suicide.

    This film is for all those affected by suicide.

    louis appleby

    Everyone is in favour of evidence-based policy but what happens when evidence isn’t there – in #suicideprevention we have few decent trials. Do we go with partial facts? Popular opinion, expert consensus, cost? Or values – and if so, whose?

  12. Re; – Drug Sfety Update by MHRA April 2019 Vol 12 Belimumab (Benlysta▼): increased risk of serious psychiatric events seen in
    Clinical trials, including interim findings from a randomised trial,
    of depression, suicidal ideation or behaviour, or self-injury in patients with systemic
    lupus erythematosus receiving belimumab compared with those receiving placebo in
    addition to standard therapy. Assess patients for these risks before the start of
    treatment with belimumab and advise them to promptly seek medical attention if they
    develop new or worsening depression, suicidal ideation or thoughts about injuring
    Advice for healthcare professionals:
    • an increased risk for serious psychiatric events (depression, suicidal ideation or
    behaviour [including death by suicide], or self-injury) has been observed in
    patients receiving belimumab from clinical trials, including recent interim findings
    from a randomised trial
    • carefully assess the risk of depression and suicide, considering the patient’s
    medical history and current psychiatric status, before belimumab is started
    • monitor all patients for new or worsening signs of these risks during treatment
    • in patients with new psychiatric symptoms or if existing psychiatric symptoms
    worsen, assess the benefits and risks of continuing treatment
    • report any suspected adverse reactions, including alterations of mood,
    associated with belimumab to the Yellow Card Scheme
    Advice to give to patients (and caregivers if appropriate):
    • people taking belimumab may experience changes in their mood or behaviour,
    and should promptly seek medical attention if they experience new or worsening
    depression, suicidal ideation, or thoughts about injuring themselves
    • patients may wish to let family and friends know they are taking belimumab so
    they can look out for any changes in mood
    Letter to
    March 2019.
    Risk of suicidal thoughts and behaviour
    An imbalance in rates of psychiatric events was observed in the clinical studies that led
    to the approval of belimumab. Assessment found the benefits of belimumab to outweigh
    the risks. However, as a condition of its licence, the marketing authorisation holder for
    belimumab was requested by regulators to conduct a randomised, placebo-controlled
    clinical trial (BEL115467) to evaluate all-cause mortality and pre-specified adverse
    events of special interest, including selected serious psychiatric events. The study is
    global and currently ongoing.
    1-year data from this study show that, compared with patients who received placebo
    plus standard therapy, more patients who received belimumab plus standard therapy
    reported events of serious depression and suicidal ideation or behaviour or self-injury
    1. Data
    derived by
    MHRA, in
    March 2019,
    Table: Patients reporting serious depression or suicidality (as-treated population,
    study BEL115467)
    Belimumab IV
    10 mg/kg (N=2002)
    Number of patients reporting serious
    depression* 1 (<0.1%) 7 (0.3%)
    Number of patients reporting suicidal
    ideation or behaviour or self-injury* 5 (0.2%) 15 (0.7%)
    *As per study investigator report

    Belimumab is authorised for the treatment, as add-on
    therapy, of adults with active, autoantibody-positive systemic lupus erythematosus with
    a high degree of disease activity (for example, positive anti-dsDNA and low
    complement) despite standard therapy. In 2018 the UK estimated exposure to
    belimumab was 102 patient-years.1

    Re; Pregabalin and gabapentin
    new scheduling requirements from 1 April
    As of 1 April 2019, pregabalin and gabapentin are controlled under the Misuse of Drugs
    Act 1971 as Class C substances
    Advice for healthcare professionals:
    • to reflect growing concern about abuse, both pregabalin and gabapentin are
    now classified as Class C controlled substances (under the Misuse of Drugs Act
    1971) and scheduled under the Misuse of Drugs Regulations 2001 (as
    amended) as Schedule 3, but are exempt from the safe custody requirements
    (see new legal requirements and resources for prescribers and dispensers
    • evaluate patients carefully for a history of drug abuse and dependence before
    prescribing pregabalin and gabapentin
    • observe patients on pregabalin and gabapentin for possible signs of abuse and
    dependence, for example, drug-seeking behaviour, dose escalation, and
    development of tolerance
    • ensure patients are aware of the risk of potentially fatal interactions with other
    medicines that cause CNS depression, particularly opioid medicines, and with
    • report suspected adverse drug reactions to pregabalin and gabapentin on a
    Yellow Card,
    The product information for gabapentin and pregabalin contain warnings about cases of
    abuse and dependence. Patients should be carefully evaluated for a history of drug
    abuse and observed for possible signs of misuse, abuse, or dependence. These
    include, for example, drug-seeking behaviour, dose escalation, and development of
    As for all medicines, patients should be given information on the expected benefits and
    potential risks of pregabalin and gabapentin, including through provision of the Patient
    Information Leaflet at dispensing. Prescribers should be aware of all medicines
    (including any over-the-counter products or illicit drugs) patients are taking to minimise
    or avoid drug interactions.
    Cases reported of abuse and dependence in the UK
    The MHRA monitors the benefits and risks of medicines in the UK and asks healthcare
    professionals and patients to report cases of abuse and dependence associated with
    Since authorisation and up to 10 April 2019, we have received 113 reports
    of abuse and 98 reports of dependence with pregabalin. Since authorisation and up to
    10 April 2019, we have received 11 reports of abuse and 9 reports of dependence
    associated with gabapentin

    Gabapentin and pregabalin can cause depression of the central nervous system,
    resulting in drowsiness, sedation, and potentially fatal respiratory depression,
    particularly if used concomitantly with opioid medicines and alcohol.
    New legal requirements for pregabalin and gabapentin
    As of 1 April 2019, pregabalin and gabapentin are classified as Class C controlled
    substances (under the Misuse of Drugs Act 1971)

    As for all medicines, the MHRA will continue to closely monitor the benefits and risks of
    pregabalin and gabapentin and take action as required.
    Gabapentin (Neurontin) is indicated as monotherapy or adjunctive therapy for partial
    seizures with and without secondary generalisation. It is also indicated for peripheral
    neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia (see
    NHS website guidance for patients)
    Pregabalin (Lyrica) is indicated as adjunctive therapy for partial seizures with or without
    secondary generalisation. It is also indicated for peripheral and central neuropathic pain
    and for generalised anxiety disorder (see NHS website guidance for patients).
    Call for reporting
    Report suspected adverse drug reactions, MHRA Drug Safety Update volume 12, issue 9: April 2019: 4.

  13. Pregablin is now prescribed for anxiety in the UK. I came off benzos and after a 2 year taper I jumped off. I descended into Hell…. DR/DP, severe insomnia, inner restlessness, suicidal idealisation. Instead of identifying withdrawal, I was diagnosed with GAD and TRD, Mirtazipine, Effexor and Pregablin were chucked at the problem. Oh and quetipine. It is so hard to taper pregablin as it is prescribed in powder form, though if I pay they may consider a liquid prescription. Quote Pregablin is the ‘New benzo but safer’ Pregablin slows the heart down but is not as ‘Nice’ as a benzo… Severe brain fog, headaches, weight gain and probably loss of libido… Though that too is Effexor… Poly drugging as a means of ‘covering’ up withdrawal is such pants… Thanks for the tip about gabapentin.. I thought they were the same. Pregablin has a street value in the UK and is being used a lot too in prisons….. As usual no-one especially PHE is really saying or doing anything. I don’ t think Pregablin is yet prescribed for GAD in the US… Who recommended it’s use here……?

    • Anna, what a mixture you’ve been put on! You say that Quetiapine was also added to the mix – have you withdrawn from that at all? Just wondering how you found it – as a ‘medication’ but more especially in withdrawal. None are easy in withdrawal are they but maybe some are harder than others?

      • Thanks Mary I tapered quetipine after 8 weeks. It was a horrible drug and made me feel so hungry…. I would be interested if prescribing for ‘withdrawal’ follows a predictable route… For benzo withdrawal… Prescribe anti-depressants.. First Mirtazipine, if that does not work prescribe Effexor…. For insomnia try melatonin, if that does not work try quetipine, as a last(Not first) resort try Zopiclone. For anxiety prescribe Pregablin… I wonder if it is a similar pattern for Anti-depressant withdrawal….. Currently I am slowly withdrawing Effexor… and Pregablin….

        • Hi Anna, so many seem to go through similar experiences don’t they. My only experience with such drugs is watching my son trying to withdraw from Quetiapine and Depakote – neither of which he has completely withdrawn to date. You seem to have a very clear view of the role of each drug that you’ve been on. Did doctors share the routines with you or are these your own deductions? My son’s experience is that they’d change dose or medication in an attempt to get him more stable. HE decided that it was time to try reducing Quetiapine when his latest increase, to 400mg daily, failed miserably – in fact, it made matters much worse. From that point on, he was very lucky to change psychiatrist and to have DH’s support to withdraw. That started over 3 years ago. He is now down to 125mg. daily. Withdrawing was horrific and he really doesn’t know if he can continue to do so in the future – he certainly won’t try for a good long while.

  14. An official website of the European UnionHow do you know?
    Court of Justice upholds EMA’s approach to transparency Share
    Press release 22/01/2020
    EMA welcomes today’s two appellate judgments by the Court of Justice1 that confirmed, in clear and unambiguous terms, the right of citizens for access to clinical study and toxicology reports submitted to EMA for the purpose of the granting of a marketing authorisation for human and veterinary medicinal products.
    “Transparency is an important feature of the Agency’s operations. We welcome today’s judgments and will continue to work to secure transparency on medicinal products in the EU, in the interest of patients and public health”, said Guido Rasi, EMA’s Executive Director. “I would like to thank all EU institutions and external stakeholders who have publicly endorsed our policies, as well as our staff who have been defending our approach to transparency for the past eight years”.
    The Court of Justice reiterated the principle of the widest possible public access to documents held by Union institutions, bodies, offices and agencies. An exception to that principle may be applied for the protection of commercial interests only if it is proven by the marketing authorisation holder/applicant that the disclosure of documents would pose the risk of a concrete harm to the commercial interests of the persons concerned. The Court of Justice agreed with EMA that such harm was not established in respect of the disclosure of the clinical study and toxicology reports at stake. The judges confirmed that transparency must be the rule and exceptions must be applied and construed narrowly.

  15. Re: Helen Salisbury: The gaps in our knowledge Helen Salisbury. 368:doi 10.1136/bmj.m161
    Dear Editor
    I was deeply dismayed to read Helen Salisbury’s article ‘the gaps in our knowledge’ about medically unexplained symptoms – and especially in context the of training junior doctors (1). I note that Dr Salisbury uses only two references. Please may I draw attention to the e–letter responses to her second reference (2).
    Please may also I draw attention to the 2017 BMJ feature on medically unexplained symptoms – and the large collection of responses there too including some of my own
    I and fellow campaigners have, for several years, been actively trying to engage the medical profession – and especially GPs – with the issue we are seeing very clear evidence of: that of patients being made ill by medicines believed by prescribers to be ‘safe and effective’ and ‘non-addictive’ and the fact that ‘effects’ of these (medicines ‘taken as prescribed’) are being further medicated – leading on to all manner of other problems and polypharmacy. Patient experiences (of the effects of the medicines) are being disbelieved by doctors as ‘medically unexplained’, as I initially wrote about, as an ‘Outsider’s observation’ in 2016 (4). As described in a previous BMJ response we have gone on to gather and put together patient evidence, drawn from a large collection written testimony submitted by patients to the Scottish and Welsh Parliaments: “The aetiology of the huge burden of ‘medically unexplained symptoms’ experienced can be clearly seen in the published patient testimony, analysed in this report” 2018 (5) (6).

    The BJGP has also published a number of my responses to various further articles about medically unexplained symptoms, such as this ‘Unexplained physical symptoms: What is being missed?” (7): “Doctors, psychiatrists, psychologists and therapists are clearly being actively trained to believe that their patients are ‘somatising’…. in fact, many are actually suffering the serious physical effects of commonly prescribed ‘safe and effective’ (sic) ‘antidepressant’ medicines, which (effects) are therefore remaining dangerously unrecognised by prescribers – with serious consequences.”
    Patient experience from our own report (Guy A, Brown M, Lewis S, Reid S, Epsley K, Cope D, et al. The Patient Voice: an analysis of personal accounts of prescribed drug dependence and withdrawal submitted to petitions in Scotland and Wales. : All Party Parliamentary Group for Prescribed Drug Dependence; 2018) (6) is quoted and formally referenced (Ref 109) in the Public Health England Review report published September 2019 (8).

    Please may I urge Dr Helen Salisbury and her colleagues to NOT train doctors to ‘not know’! And instead to really start to explore what is really happening to far too many people: being made very ill by ‘medicine’. Please see this ‘Patient Journey’ Infographic – and perhaps use it in your training for doctors? (9).
    (If you need this infographic in a different format, please email
    Competing interests: No competing interests

  16. News
    US electronic records company fined $145 million for pushing doctors to prescribe opioid
    Janice Hopkins Tanne
    Author affiliations
    Practice Fusion, an electronic health records company, agreed to pay $145m (£110.7m; €131.5m) to settle civil and criminal charges with the US Department of Justice for encouraging doctors to prescribe opioids. The company got a $1m kickback from pharmaceutical company “Pharma X” to promote opioid prescribing through its programmes for doctors.1

    Most of the fine will go to the federal government and other payments will go to individual states. Pharma X, a major opioid company, was not identified in the settlement.

    From 1999 to 2017 the US opioid epidemic has killed more than 700 ​000 Americans.2

    Practice Fusion offered free electronic health records software and sometimes computers to small and single doctor practices. Its electronic health records received certifications from the Office of the National Coordinator for Health Information Technology

  17. Re: Should we be worried about the NHS selling patient data?
    Dear Dr Bhatia,
    Thank you for your comments, and for highlighting this. The statement you mention has been removed from the article to avoid misleading readers, and a correction has been issued to make this change clear.
    Tom Moberly
    Competing interests: No competing interests
    30 January 2020
    Moberly Tom
    UK Editor
    The BMJ
    Re: Should we be worried about the NHS selling patient data

    Dear Editor,
    At the end of the article, mention is made of “Opting out could affect their health services, as many third parties are involved in processing data and care delivery”.
    That is misleading.
    Patients have every right to prohibit the release of personal, confidential, identifiable data (which includes pseudonymised data) from a data controller such as their GP surgery or NHS Digital, for secondary purposes (that is, beyond their direct medical care)………….

  18. The WHO Malaria Vaccine Trial: a bioethicist responds
    Dear Editor,

    In its response [1] to Peter Doshi’s article on the malaria vaccine trial,[2] the WHO does not challenge the facts presented. They do, however, dispute the ethical conclusions drawn from these facts, asserting the malaria vaccine trial was “conducted in accordance with established and recognized national and international ethical standards.”[1] In the following, I examine the WHO’s claims about the ethical ramifications of the study.

    The WHO consistently denies that the malaria vaccine trial as a whole is research, describing it instead as a “systematic evaluation of programmatic implementation” that is “good practice—not medical or scientific experimentation.”[1] Data collection is described as “independent of the vaccine implementation by the EPI programme.”[1] In fact, from the start the WHO designed this study as cluster randomized trial to address the effectiveness, safety and feasibility of the novel malaria vaccine. In their March 2017 presentation to the WHO’s Malaria Policy Advisory Committee, David Schellenberg and Mary Hamel described the study as using a “cluster randomized design.”[5] The use of a cluster randomized design indicates that it was always intended to be research. Further, since the malaria vaccine program and data collection are constituents of a randomized trial, they both constitute research and are subject to international ethical guidelines.

    This puts the WHO’s claims about the use of randomization in a new light. Citing a scarcity of vaccine supply, the WHO contends that the rollout of malaria vaccine to districts in Ghana, Kenya and Malawi was randomized as a “fair way to allocate limited vaccine doses.”[1] In his response, Peter Doshi finds the claim “at odds with every other WHO document I have reviewed.”[3] He notes that the WHO’s website reports “GSK is donating up to 10 million doses of RTS,S [malaria vaccine] for use in the pilot programme”[4]—more than enough for the 360,000 children enrolled in the malaria vaccine trial annually. If vaccine supplies are indeed scarce and randomization was not for research purposes, why didn’t the WHO choose one of the more obvious paths of either vaccinating all children in one country, so that no child is denied access to a government program, or providing vaccine to districts across several countries with the highest rates of malaria in children? Indeed, it is plain that districts were randomized to receive the malaria vaccine program or not because the WHO and its host country partners were conducting research.

    International ethical guidance specific to cluster randomized trials is found in the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials[6] and the CIOMS/WHO International Ethical Guidelines for Health-related Research Involving Humans (especially guideline 21).[7] The WHO malaria vaccine trial violates ethical requirements in both international ethics guidance documents.

    The Ottawa Statement says that “[r]esearchers must submit a CRT [cluster randomized trial] involving human research participants for approval by a REC [research ethics committee] before commencing.”[6] “This includes CRTs conducted outside health care settings, such as…public health research.”[6] The CIOMS/WHO guidelines add that in “externally sponsored research, ethical review must take place in both the host and the sponsoring institution.”[7] In its response, the WHO makes clear that only “observational studies to evaluate the routine use of the vaccine” were submitted for research ethics committee review.[1] Randomized implementation of the malaria vaccine was approved by the Ministries of Health of Ghana, Kenya, and Malawi and not the research ethics committees.[1] Thus, host country research ethics committees were not given the opportunity to review questions of equipoise or consent for vaccination for the WHO malaria vaccine trial.

    Why would the WHO not submit the full cluster randomized trial for research ethics committee review? It appears that the WHO is labouring under the misapprehension that government programs do not require research ethics committee review even when these are part of a cluster randomized trial. After all, governments have a democratic mandate to provide routine public health programs to citizens. But in randomizing districts to receive malaria vaccine or not, the government was not implementing the vaccine routinely; it was conducting research. As we explain elsewhere, the “government is collaborating with researchers to randomly allocate provinces [or] communities…to intervention or control…so the program may be evaluated.”[8] “Even if the government is the author of the program, researchers are the authors of the study design. And it is the design that triggers equipoise [and consent] issues…that must be assessed by the research ethics committee.”[8]

    Further, both the Ottawa Statement and the CIOMS/WHO International Ethical Guidelines require consent for drug or vaccine interventions in cluster randomized trials.[6,7] Indeed, the CIOMS/WHO guidelines consider a hypothetical cluster trial of a school-based vaccination program and analyze the role of parental consent. They say, “parents will not be able to consent to their children’s school being randomized to a vaccination program or to being allocated to that cluster, but they could consent or refuse to consent to their child’s vaccination at school.”[7] This same reasoning applies to the WHO malaria vaccine trial. Parents cannot meaningfully consent to health districts being randomized to the vaccine program, but they can—indeed they must—consent to their child receiving the malaria vaccine.

    In their response, the WHO tells us that “parents receive information about the vaccine from the ministry of health and can decide to present for, or to opt-out of, any or all vaccinations.” But there is no requirement that parents attend a community information session. Crucially, no parent is informed that their child is to be a research participant in a cluster randomized trial. Thus, the response from the WHO only provides further confirmation that the malaria vaccine trial represents a serious breach of international ethical standards.


Leave a Reply to Anna