Our Unequal Struggle with Health Systems

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November 23, 2022 | 17 Comments

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  1. When Kevin Stewart got the job, he was not particularly well-versed in his job title.

    You might have thought that someone new to this role, would have an open mind and would like to listen to those who have more experience than him. In the interview below, he was planning to listen to other bureaucrats.

    “I know folks who unfortunately have committed suicide. And it’s sometimes very difficult to understand why they took that course of action.”

    “and an updated suicide prevention action plan”

    Is it likely that in this respect, he will become another Louis Appleby, who in all the years of addressing Suicide Prevention always misses the Elephant in the Room.

    In fact, suicide is the wrong word.

    Driven to death, usually in horrific circumstances, from drugs your doctor has given you, is not a choice. Propelled to take actions that you would normally never do, is more like murder. Who in their right-mind would jump in front of a train, jump from a tall building or stab themselves.

    If Katinka had not been on the drugs, she would not have waved a kitchen knife around, with the very real attempt to harm herself.

    Paroxetine, Fluoxetine, Citalopram, and more, can lead to horrific outcomes for the unwitting patient.

    Is it more trouble than it’s worth for the doctor to open his mind; is every book, newspaper article, ghostwritten article, fraudulent clinical trial, legal case, too hot to handle – are they just out-of-their-depth and medicine just something they use as a plumber uses a wrench.

    Square Peg – Round Hole…

    Listening first: interview with mental wellbeing and social care minister Kevin Stewart

    https://www.holyrood.com/inside-politics/view,listening-first-interview-with-mental-wellbeing-and-social-care-minister-kevin-stewart

    Given the focus on both social care and mental health as a result of the COVID-19 pandemic, Kevin Stewart, the new minister for mental wellbeing and social care, has a pretty significant portfolio on his hands.

    This includes a consultation on the creation of a national care service, one of the Scottish Government’s highest profile first 100 days commitments, as well as the need for improvements to mental health waiting times and social care services generally – the latter brought to the fore by deaths in care homes and discussions of poor pay in the sector.

    It’s a bit of change from his previous portfolio of local government. But Stewart is looking forward to it.

    “Nobody can say that I don’t like a challenge,” he says. “And I have to say that I am very, very excited about helping to shape a national care service.

    “You know, I think that this is probably the biggest change in our public sector landscape possibly since 1948, since the formation of the National Health Service. So that’s very, very exciting indeed.”

    Stewart says he already has a “fairly good understanding” of social care, having previously been local government minister and before that, convener of the local government committee, but on the mental health side “it would be fair to say I have a little bit of a learning curve”, although he brings his own life experiences to the role.

    But Stewart is very clear that he won’t be making any decisions in either side of his portfolio without first hearing from the people affected by them.

    “In this role, like in my other roles in the past, one of the things that I am very keen to do is to ensure that the voices of those folks with lived experience are brought to the fore and heard, whether that be in the mental wellbeing side or in the social care side.

    “I think in my previous ministerial role we’ve seen some real differences in terms of homelessness policy and legislation, and I think if we hadn’t had the voices of lived experience at the table, then we might not have got all of that right.

    “And, you know, I’m not saying that everything is perfect, because we always need to tweak, but a lot of the things that we have done in recent times in that area has greatly benefited from the experiences of people. And I want the same thing here.”

    With the creation of a national care service being so high profile, there is a risk that could dominate over everything else, but Stewart says he will not lose sight of the need for improvement across the board.

    “We’ve got to get this absolutely right in terms of the national care service, but that’s not going to blind me or stop me from dealing with what we need to do in the here and now,” he says.

    “As you can well imagine, I’ve spent the last number of days talking to a lot of folk, in particular, the civil servants, and I’ve made it very clear in all of this that we have got these top lines, key policy planks that were in our manifesto, and we must deliver on them, but also, we need to continue to look at the service delivery on the ground and how we can improve that, even before we reach the stage of a national care service.”

    And given that the Scottish Government recently went through the process of setting up another national agency, Social Security Scotland, from scratch, under the leadership of former health secretary Jeane Freeman, Stewart says he will also be seeking to learn lessons from that.

    “I think it would be fair to say that I’m likely to have a fair few conversations with Jeane Freeman and others who were at the forefront of that. You know, there is absolutely no point in trying to reinvent the wheel.

    “I will go to the offices of good folk, even those folks who have supposedly retired, and seek their advice and views.

    “That is the right thing to do without doubt. So Jeane might get a bit sick fed up of me over the next wee while. I hope that’s not the case.”

    On the mental health side, there are a number of commitments to spending, including a 25 per cent increase in mental health funding over the course of the parliament, bringing it up to 10 per cent of the total health budget – a “big shift”, Stewart says – and, in the short term, £120m has been allocated for the Mental
    Health Recovery and Renewal Fund, of which £34.1m is going towards improving child and adolescent mental health services (CAMHS).

    Discussions are ongoing about how best to use the remaining unallocated funding and Stewart is clear that he wants to take the time to see that used well rather than just out the door quickly.

    Mental health charity SAMH has called for an end to CAMHS rejections. When asked about that, Stewart says that he will “have to look very carefully at what is currently going on out there”.

    He notes that as a constituency MSP he was previously getting a lot of complaints about services in Grampian, but there seems to have been an improvement there that perhaps could be learned from.

    “I want to see that best practice exported so that we get this right for people, so that we can see folks’ satisfaction rates go higher and so we have less folks saying, we’ve gone through this and yes, we’ve had the help but that last bit of the jigsaw they feel is missing.

    “Let’s see if that last piece of the jigsaw is really missing first of all, and if it is, what do we need to do to make that improvement.”

    Other pressing issues in mental health include following up on the Eating Disorders Services Review, which was published in March and included 15 recommendations for action, including an urgent request for COVID funding, and an updated suicide prevention action plan, due this year.

    Stewart says he’s “not going to be pushed into timelines” on responding to the recommendations around eating disorders, having only been in the job one week at the time of the interview, but being a close friend of former SNP MSP Dennis Robertson, whose daughter died of an eating disorder in 2011, he will make sure that they do the right thing.

    “You will know that I’ve spoken in a number of debates in parliament on the subject of eating disorders.

    “You’ll know that Dennis Robertson, former MSP for West Aberdeenshire, and I were the greatest of buds. And obviously, I know about the Robertsons’ family experience of all of this, which is extremely sad.

    “And I said to Dennis when he left parliament that I would continue to highlight these issues, and a number of colleagues have done likewise, because obviously hearing that first-hand experience on a regular basis keeps that up there.

    “So I’m going to make sure that we do the right thing so that others don’t have to face the kind of pain that Dennis and Anne Robertson have faced, and the family have faced.”

    We both get a bit teary talking about the Robertsons’ experience, and I note that it is an emotionally challenging portfolio Stewart has been given.

    “I think you can look at these things a number of ways,” says Stewart. “And some folk have looked at the remit that I have and gone, ‘Oh my, I could never do that.’

    “However, the thing is that somebody has to do these things.

    “And the key thing for me in all of this is that we all have had experiences of folk that we know that had been affected by poor mental health.

    “I know folks who unfortunately have committed suicide. And it’s sometimes very difficult to understand why they took that course of action.

    “And, you know, I think that we need to do all that we possibly can to improve mental health and support in this country.

    “I think in some regards we’re in a better place now because people are more willing to talk about their own mental health more.

    “Not everyone. I think we’ve still got a long way to go in terms of destigmatising some aspects, some views of folk, but we have come a long way in what I think is a fairly short time… And we need to get to a stage that we talk about our mental health much, much more.

    “And where bad things happen, rather than box it up and keep it to yourself, we have to be able to have that release and be able to talk to one another about how we’re feeling about these things too.”

    Stewart is unsure whether he has suffered poor mental health as such, but he can certainly relate to the experience of struggling emotionally.

    Asked about his own experiences, he says: “I’ve never been diagnosed as having any poor mental health, but, you know, it’s often difficult to say, not having a diagnosis of depression.

    “Have I ever been depressed? And the answer to that is probably yes.

    “You know, I spoke a number of times during the course of the equal marriage debate around about how I’d kept myself closeted for too long and I talked then about my unhappiness.

    “Now, was that just unhappiness or was it something more? I don’t know, is the answer. I don’t.”

    But he is also influenced by the experiences of others he knows.
    “The fact [is] that all of us know someone who has either been diagnosed with depression or has gone through various other things.

    “I don’t want to identify people… but I know folks who have been diagnosed with a number of things and sometimes hearing the journey that they’ve been on to try and get, first of all, recognition of what it is, and then the right treatments, and often the treatment in some cases is not quite so easy to get to either, and some of that, it’s very tough to listen to.

    “A lot of those bad experiences are from yesteryear, and you do hear much better outcomes for some folk now with similar difficulties, so again, I think we’re getting better, but we need to continue that improvement.”

    With regards to what he personally wants to focus on in the new role, Stewart says that’s a luxury he doesn’t have.

    “I don’t think that you can have the luxury of choosing your own personal favourite things in any portfolio.

    “I think our manifesto sets out a clear pathway around about what we need to do.
    “Obviously, the 100 days stuff is extremely important, but that wider commitment of delivering over the course of this parliamentary term, there will be a major focus in that.

    “However, I come back to the point… [that] this is about continuously improving delivery. Because at the end of the day, whether it be any of the mental health services or whether it be delivery of social care, you know, we are talking about people.

    “A frustrating thing for me always is, sometimes people talk about numbers, you know, everything is a stat, but the key thing in all of this that we canna lose sight of, that I can’t lose sight of, is that we are dealing with people, and we need to get these services right for folks.”

    Kevin has made it clear in his own mind, that he is not interested, in fact his rather cavalier attitude predisposes him to give out the wrong signals.

    Giving out the wrong signals, is acutely dangerous for patients – most doctors do it and none, to my knowledge, live to regret it.

    https://holeousia.com/2022/11/21/depression-pills-and-dependence-a-timeline-following-a-letter-in-the-times/

    Why are they so trusting of these drugs, with no cause for alarm – they mostly trust the vaccines and so, in their minds, Pharma are now the saviour –

    An About-Turn is Due…

  2. Today Sorry I am not able to open the file but coincidently this is on BBC radio SOUNDS today. There is a gut wrenching account from one woman about her experience which mirrors everything so many of us have been saying about lack of humanity, of ignorance and lack of knowledge or willingness to earn. This time of what is being claimed to be an increasingly almost common illness., of over drugging including forced drugging and of course not being believed that she knew what she was talking about to the increasing number of psychiatrists and nurses she was referred to. She was clued up about the drugs she was prescribed for example that mixing them was harmful to the point of turning depression into bi-polar,( But by the time people are clued up the damage has often been done.Nothing has changed in that respect). What has changed according to the programme is the number of people being diagnosed as Bi-Polar after many years of experiencing the characteristic depression and mania. What is puzzling though is how can the diagnosis be reliably said to have begun so many years ago for a growing number of people.. Maybe in some cases it wasn’t bi-polar but drugs on top of drugs but have have clouded the possibility of a reliable diagnosis. If doctors were monitoring people they prescribe medications for properly the cascade could maybe be avoided but how is that to happen when experts are not available . the college of psychs are promoting a scheme for consultants to work full time from home The interviews for medics used to probe into their reasons for wanting the job, a common reason obviously being partly at least an interest in ‘caring for ‘ people in different ways ,Tt almost sounds archaic when what they should be saying to get the job is an interest in tech to assist in keeping a distance from human beings .

    Diagnosing bipolar disorder and the launch of the 2023 All in the Mind Awards
    All in the Mind
    AllInTheMind-20221122-DiagnosingBipolarDisorderAndTheLaunchOfThe2023AllInTheMindAwards.mp3
    https://aod-pod-uk-live.akamaized.net/mpg_mp3_med/modav/bUnknown-d25b46ab-0487-485b-bdb4-05d149de9463_p0dj2ggl_cUnknown_1669142672769.mp3?__gda__=1669244674_ea4153a41951d920b20113d78e74e1b1

  3. Think Kevin Stewart may consider he’s too small a fish to dare ask the sharks such questions in what has become a polynational pond. To digress for a moment.

    Having watched parts of Canadian Parliamentary sessions where the opposition gets stonewalled when asking to see the pharmaceutical contracts for vaccines, EU sessions asking the same thing and getting no where, the Italian opposition getting copies of vaccine contracts so redacted that nothing can be gleaned from them etc., and multiple lawyers letters to the FDA pointing out they are braking their own rules, revelations that the collapsed FTX was funding the methodically questionable ‘Together Trials’ which found no difference in outcome for Ivermectin, I was about ready to relapse and go back on my Anticonspiritol capsules when I viewed the latest webcast of Trail Site News.

    “A legal framework has been set up to merely toss away all the standard laws, regulatory compliance norms, and more associated with traditional FDA regulated medical product development and commercialization, argues Sasha Latypova.

    I think this sums up the state of many a nations’ health care system today.
    Sasha has quite an impressive résumé with much experience having worked for many pharma companies and contract research organizations, so I’m inclined to think she knows what she’s talking about. She also campaigns against the Weaponization of Public Health Through State Legislation.

    Now going back to err… Oh darn! Just the vapour from the opened bottle of Anticonspiritol has taken effect and can’t seem to remember what I was going to say.

    References:
    Example of one of the lawyers letters to the FDA:
    https://icandecide.org/wp-content/uploads/2022/11/Peter-Marks-Nov-2022-Just-a-Minute-videos-lack-disclaimer-final.pdf

    Trail Site News: Emerging Federal/Pharma ‘Cabal’? Organic Evolving State-Influenced Capitalism or Something Else?
    https://www.youtube.com/watch?v=CcU-ZaJetMA

    Same thing as above but in but in the form of an article.
    https://www.trialsitenews.com/a/emerging-federaldefensepharma-cabal-organic-evolving-state-influence-capitalism-or-something-else-f4360af6

  4. Someone on Facebook says;-
    Get Me Out of The State Hospital! – Facebookhttps://en-gb.facebook.com › Facebook Groups

    The PR from Carstairs

    Carstairs: The truth behind psychiatric revolution at Scotland’s State Hospital
    20th June 2021
    By Ally McLaws
    4 Comments
    Scotland’s State Hospital is revolutionising judicial systems across the world
    Scotland’s State Hospital at Carstairs is achieving international recognition for outstanding success in treating and rehabilitating some of the most complex patients in the world.

    Far from housing prisoners, the State Hospital is part of the NHS and has been undergoing a quiet revolution over recent years and is now being studied by foreign Government’s looking to change their penal systems.

    The building blocks to transform it into a world leader in the treatment and rehabilitation of desperately ill mental health patients are threefold.

    First was the policy change to streamline law and mental health into a single approach enabling mentally disordered offenders to be taken out of the court system which is designed specifically for criminals.

    The Millan Principles, the latest changes came into force in June 2017 unlocking further the door for independent advocacy enshrining in legislation the right for a patient to have a “named person” who can act on their behalf and that all treatment under the Mental Health Act must comply with the Human Rights Act 1998 giving patients the right not to be treated in an inhumane or degrading manner.

    The second key development was to replace the barbed wire and accommodation that was built in the late 1930s and was, to all intents and purposes, a carbon copy of a prison of war camp to the naked eye and so the NHS delivered a total rebuild of purpose built facilities.

    The third element has been empowering the clinical teams with the freedom to develop and participate in groundbreaking new approaches to treatment and rehabilitation that has sparked ownership, pride and partnership between all staff disciplines and patient groups.

    Trailblazing treatments
    FOR the very first time some of these patients are being offered and are responding to psychiatric treatments, compassionate care and respect.

    This multi-layered programme fueled by NHS staff enthusiasm, skill and compassion is delivering gold standard results in the most challenging of circumstances.

    HeraldScotland:
    For these patients psychiatric help alone cannot adequately help rehabilitation success.

    Violence levels have dropped dramatically, communication skills and practical skills have developed, and there are increasing levels of success in moving patients on to lower security hospitals designed specifically to progress rehabilitation to the next level.

    Where once a placement at the State Hospital was regarded as a “sentence” to be locked up and the key thrown away… it is now an NHS care system offering hope and recovery.

    In many ways it is difficult to feel sympathy for them … but the power of extreme schizophrenia on the mind, its ability to create compelling voices and violent actions, is a cruel and often tragic health issue.

    These men, the State Hospital only treats male patients and usually there are just over 100 of them at any one time, desperately need help.

    But in many other countries the systems in place are very much outdated Pakistan’s penal institutions, for example, made no allowances for mental health.

    Influencing Pakistan
    NOW Pakistan’s government legislators, its legal profession and the country’s mental health experts have turned to Scotland to see how they can change things and replicate our policy approach, emulate our treatments and adopt our care regimes.

    At Scotland’s State Hospital at Carstairs it is Consultant Forensic Psychiatrist Dr Khuram Khan who is leading this work under a Global Citizen programme designed to support Scotland’s international reputation and role in the world as an exporter of knowledge and expertise.

    He and colleagues are working very closely with peers in Pakistan to usher in an education programme. Dr Khan explains: “Scotland is decades ahead of Pakistan. We have strong partnerships and co-ordinated working between mental health and law and linked training, unified approaches to patient needs and true co-operation. “Here in Scotland law and psychiatry are on the same page with the school of forensic mental health right at the centre of things.

    “Through international seminars and networks Pakistan learned of Scotland’s pioneering approaches and requested support to achieve what is being delivered here.”

    Over the past 18 months Dr Khan and others have delivered webinars, training sessions and facilitated visits… and already things are starting to change.

    Last year Pakistan changed law to end capital punishment for blasphemy…a common reason for psychiatric patients to be arrested, convicted and locked up. Now the next steps are being taken to develop the system to give those same patients the proper care rather than being treated as criminals.

    The revolution of care in Scotland had to start with the creation of the appropriate facilities and NHS Scotland invested significantly in the total demolition and rebuild of the State Hospital which was completed in 2012.

    The new purpose-built facility features the highest levels of security – safety is paramount for patients, staff, volunteers and the public – but this has been achieved sympathetically with healthcare an equal focus for design and implementation. The vast majority of security staff are re-trained healthcare professionals ensuring that the healthcare ethos runs through the entire hospital from clinical staff teams through the facilities and other support functions and right into the security teams.

    Rooms are designed to deliver segregation when required and social areas for rehabilitation when appropriate.

    ‘Harmony’ aim
    GYM equipment is available with great emphasis is placed on enabling patients to exercise with groups or individuals they can be with in harmony and avoid tensions.

    There is even an animal assisted therapy area and security systems built into modern architecture and landscaped grounds – all to achieve maximum efficiency with minimal intrusion and visibility.

    This combined total “team” approach to care and treatment creates the multi-disciplinary input to treatment planning and rehabilitation goals.

    Dr Gordon Skilling has worked in the State Hospital as a consultant forensic psychiatrist for the past 11 years but it has been in the last couple of years that he has seen the most remarkable changes in successful outcomes – and it is all down to an approach termed within the hospital as “Realistic Medicine”… in a nutshell it recognises there can be times when there is “over diagnosis” and “over treatment” and “too much medicine”.

    “The most important resource is our staff and how we work together for patients and their families. Our approach is much more about recognising the challenges to patients and to staff and to the development of care and understanding.

    “First and foremost, our staff volunteer to take part in Realistic Medicine group sessions with patients and get to know them in a way that no-one else has previously.

    “These patients – yes some have done terrible things – but so many of them have lived such awful lives of neglect and abuse and no-one has worked with them to give them confidence or show care and respect. “Gone are the days when treatment evolved around a set and timed session with a psychiatrist.

    “It’s about empowering these groups to be innovative and creative and practical. Changes that really matter and where taking part is a huge aspect of the process of success – bringing everyone together as a team with equal opportunity to make a real difference. Many small changes bringing about a notable transformation in approach and treatment and care and respect and experience.

    “Facilitating improved menus, access to gym equipment, quality improvement across the entire hospital regime – getting involved in plastic free canteens delivered opportunity and responsibility out with health but hugely rewarding for everyone involved to achieve – patients themselves entrusted and participating in areas that are not directly to do with treatment but have direct spin-off effects from being involved in decisions and influencing change.

    Creating new collaborations between staff groups and between staff and patients. The enthusiasm spread and fantastic levels of participation.” But even this level of innovation and personal team approach by wide sections of staff cannot work for those patients with extreme complex needs above and beyond their mental ill-health. And this is where Dr Jana De Villiers as the State Hospital’s Forensic Psychiatry Intellectual Disability specialist comes in to add another layer of expertise to the care and treatment regime.

    ABOUT a dozen of the patients have significant disability issues – apart from severe mental health issues such as schizophrenia – including epilepsy, speech, sight or hearing loss vulnerable and HDHD. – they are highly complex.

    Dr De Villiers: “They are a risk to others… these are people who, in some cases, have had the most appalling childhoods possible. They can be violent and frustrated. They find communication very difficult. These patients need special approaches and that’s exactly what we have developed – and are still improving on – … and over the past few years we have witnessed remarkable success. Despite their often un-imaginable backgrounds of misery and neglect we work to offer them hope and support and education and prepare them to move forward with their lives.

    “This cannot be a quick fix – it could take six years – sometimes longer to achieve real progression in rehabilitation but that is the aim we have for every patient. We are offering hope and progression where before there really wasn’t any.”

    “Four years ago there were high rates of violence amongst these patients.

    “Some of them have done awful things. They could be very violent and dangerous and attack staff – try to strangle them. “But we have worked very hard with this group to educate and deliver clinical solutions/treatments and we have reduced dramatically the levels of violence … some who were very violent are now able to have good conversations with other patients and with staff and to participate in games and sport.

    “We now have a fairly peaceful regime. Me and my team see progress…and we are hugely encouraged to continue to develop our approaches further.”

    One of the longest serving members of the clinical team at Carstairs is Consultant Nurse Practitioner Pat Cawthorne. After 30 years of nursing – 21 of them at the State Hospital – her energy and enthusiasm for her work has never been higher: “It’s just the very best job to work with these patients and see the success.

    The old way was to lock them up and throw away the key. Now people talk about mental health – it is so important to normalise it – to emphasise that those who suffer mental ill-health are not alone and discuss experiences.

    There have been dramatic changes in the past 20 years. The biggest change has been in last 21 years. Changes to the legislation, changes to psychiatry and to evidence based psychological therapies too.

    And now at the State Hospital we see dramatic reductions in violence, the delivery of structured clinical care to a standard that is equal to the best anywhere in the world.

    I am really proud of what the staff here are achieving and it is a recognition of those achievements that teams from other countries in the world are coming here to learn from what we do.”

    Calmly and effectively leading his team at the State Hospital is the Chief Executive Gary Jenkins who arrived at Carstairs two years ago from directing services at the Beatson West of Scotland Cancer Centre and the Regional Institute of Neurosciences.

    Within his first year in charge the State Hospital won Psychiatric Team of the Year Award for Quality Improvement. Gary adds: “There is much more that we can still do to improve the experience of staff, patients, carers and volunteers. My senior leadership team and the Board are committed to achieving continued improvement and success in the months and years ahead … and to replace the reputational tag in Scotland of “notorious mental health prison” with how it is regarded worldwide: A leading hospital setting new standards and successes in treating the most challenging patients in society”.

    Hello Barry Noticed your comment on the blog. Great to read your comment here as well.
    Barry Gale says
    23rd June 2021 0:00 am

    How can this be an “investigation” when the only sources of information are the managers and staff of the hospital you are investigating? Where are the commendations from patients, their relatives and the international community? What awards has the hospital received for this ground-breaking work? Which seems to consist of nothing more than starting to treat patients more like human beings – welcome to the 21st Century Mr Jenkins. This is really a PR campaign on behalf of the hospital.

  5. Last month I spoke with a woman who was so pro-vax she volunteered for a covid vaccine trial, and she experienced horrifying toxic effects ON THE RIDE HOME after her first jab. She was diagnosed with “anxiety” and prescribed benzos.

  6. In regard to those conditions the medical profession calls “mental illnesses,” the whole notion of agnosia seems preposterously self-refuting. If the drugs they prescribe for these conditions are curing “mental illness” — in other words making the patient more rational — why is it that the patient in his (presumably) more rational state cannot see this?

  7. This Thriller That Calls Out Pharma and FDA Is a Chiller

    https://medshadow.org/paul-john-scott-malcharist-review/

    Pharmaceutical company executives do not take a vow to “first, do no harm.” In fact, pharma firms are nearly all for profit companies. If they are corporations with shareholders, too, the firms have a legal responsibility to maximize profit. 

    Malcharist is a book about how pharmaceutical companies allegedly can harm patients with their drugs and get away with it, while profiting mightily from their unethical ways. While Malcharist is fiction, it promises to deliver a “fact-based” exposé about a fabricated drug company, which knowingly unleashed a medicine that caused dreadful side effects. Malcharist is a made-up word that means “bad power” or “bad spirit,” according to its publicity material.

    I received Malcharist during the summer of COVID-19, July 2020, and then set it aside. The year was so dark and the news was continuously sad. It was a time I needed to trust that our medical system could save us all from the pandemic. I couldn’t handle learning about evildoings, which I realized even before reading the book, probably do occur. 

    Exposés, whether factual or fictional or some of both, are often imbued with so much hate for the perpetrator, that the humanity of the rest of the world fades away. And especially in the summer of 2020, I was depending on my belief that there are very few truly bad people in the world. People may be weak or gullible or misguided, but I cling to my belief that very few set out to do harm.  

    When I did read Malcharist, I found it to be much more engaging and readable than I expected, except for the first chapter. Be warned, that the book’s beginning is harrowing. It depicts the inner life of a man, Mark Barry, experiencing akathisia brought on by using a drug approved by the Food and Drug Administration (FDA). Akathisia is an uncontrollable urge to move with a constant sense of restlessness, and it has been linked to suicides in people with no history of suicidal ideation. I’ve never understood the power and pain of akathisia, but this chapter is as close as I hope to ever get. 

    Mark was taking the drug as part of the drug company’s clinical trial, designed to persuade the FDA to broaden its approved use to a new, much bigger, category, which would be much more profitable than the narrow use the FDA had already okayed. 

    The rest of the novel centers on a woman who ghostwrites medical journal articles for doctors. From there the story takes off and becomes a fascinating dive into the complex world of clinical trials and manipulated scientific data. 

    The plot moves briskly, too, as a key character evolves and matures. It wraps up with a bit of an unlikely happy ending, which, luckily, helped me sleep better that night. It would have been reassuring if the plot had been countered with a subplot of a pharma company that displays an ethical spine. But that was not to be.

    Read this book if you believe that the FDA completely protects you from dangerous drugs. Read this book if you are concerned about the side effects of the medicines you take. While I knew that much of this goes on, it was powerful to take in the scenario in the full context. 

    There are medicines that can cause devastating side effects in patients. The FDA is in charge of ensuring that all drugs are both safe and effective before approved. However, the FDA makes its decisions based on studies conducted and reported by drug companies. Malcharist makes it painfully clear exactly how flawed that system is

    Scott, Paul John, (2020), Malcharist, Samizdat Health Writer’s Co-operative Inc. ISBN-13 : 978-1989963005

    Denmark Is the Only European Country Where the Usage of Depression Pills Has Dropped

    https://www.madinamerica.com/2022/11/denmark-depression-pills-dropped/

    I am therefore convinced that it is primarily due to my tenacity that the usage went down in Denmark. I say this to encourage people to fight for a good cause, which is that depression pills should not be used by anyone. As I have explained in my Critical Psychiatry Textbook, which will soon be serialised on Mad in America, it is indisputable that depression pills do much more harm than good. Since doctors cannot handle them, they should be taken off the market.

    Prof. Peter C Gøtzsche
    @PGtzsche1
    ·
    6h

    Psychiatric patients are forced by the court in sham trials to take drugs and doses that are dangerous. Human rights violations in Alaska ignore previous Supreme Court rulings. The power imbalance and abuse are extreme. See our preprint research paper

    https://www.medrxiv.org/content/10.1101/2022.11.22.22282650v1

    We assessed the records for 30 consecutive petitions for mental health commitment in which an involuntary medication order was requested from Anchorage, Alaska. In 29 cases, the commitment petition was granted. One patient requested a jury trial and the jury found in her favor. The forced medication order was granted in 27 of the 30 cases. In 26 cases, in violation of previous Supreme Court rulings, the patients’ desires, fears, wishes and experiences were totally ignored even when the patients were afraid that the drugs used for psychosis might kill them or when they had experienced serious harms such as tardive dyskinesia. The ethical and legal imperative of offering a less intrusive treatment was ignored. Benzodiazepines were not offered. Psychotherapy was not offered or mentioned in fifteen of the 30 cases. The providers claimed it does not work, even though that statement is blatantly false. The legal procedures can best be characterized as a sham where the patients are defenseless. The power imbalance and abuse were extreme and several of the psychiatrists who argued for forced treatment obtained court orders for administering drugs and dosages that were dangerous. Forced medication should be abandoned.

  8. The farce of access to records roll-out – rolls on . With both sides throwing their weight around . It’s going to be easier to get hold of paper records for some time yet.

    Pulse Today
    BMA gives Government seven-day ultimatum over online patient access to GP records
    Costanza Potter
    25 November 2022

    Exclusive The BMA has given the Government a seven-day ultimatum to address concerns over online patient access to GP records before it takes ‘significant action’, Pulse has learned.

    Automatic access to patients’ prospective patient records is due to be switched on by Wednesday next week, following delays related to concerns about patient safety.

    But a letter sent to practices on Tuesday, seen by Pulse, said that the BMA ‘continues to have significant concerns about the rollout’ and suggested that it has threatened to block it.

    England GP Committee deputy chair Dr David Wrigley, who is leading on the issue, said: ‘The BMA sent a letter written in the strongest terms last Friday to the Government and we have given them seven days to respond otherwise we will consider further significant action.

  9. ” it was a better alternative to “blowing your brains out.”

    For: Professor Allen Frances

    https://twitter.com/KingsIoPPN/status/1595061029264064512

    Allen Frances Retweeted

    Tania Gergel
    @DrT_Gergel

    Looking forward to joining @arun_chopra @AllenFrancesMD
    & Theo van Willigenburg to debate the pros and cons of allowing people to use advance directives to commit to future involuntary treatment.

    Chaired by the IoPPN’s new ‘Professor of Practice’ – Sally Marlow – @northactually

    Institute of Psychiatry, Psychology & Neuroscience
    @KingsIoPPN

    Join the @MaudsleyDebates on ‘#SelfBindingDirectives: This house believes that people should be able to commit themselves to future involuntary treatment.’
    Date: 23 Feb 2023.
    Register: https://bit.ly/3f6U7l4

    18 June 2021

    Do service users with bipolar disorder want to choose enforced treatment ahead of future episodes?

    https://www.kcl.ac.uk/news/do-service-users-with-bipolar-disorder-want-to-choose-enforced-treatment-ahead-of-future-episodes

    A new study from researchers at the Institute for Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London, in partnership with the charity Bipolar UK, has explored how people living with bipolar disorder feel about the idea of a ‘self-binding directive’. This would give people the opportunity to choose in advance the care they would receive on becoming unwell including giving instructions to clinicians to overrule treatment refusals during future episodes of severe illness.

    Self-binding directives are designed to give an individual autonomy over their care during future periods when illness renders them unable to make an informed decision about medical treatment. This study was co-produced within a multi-disciplinary team, including ethical, clinical, and legal expertise, as well as lived experience of bipolar disorder and advance decision-making.

    This paper, published in The Lancet, shows substantial support among people with lived experience of bipolar disorder and analyses their reasons for endorsement. At the same time, it explores the reasons given by a significant minority of respondents who were either ambivalent to, or actively against, the idea of such directives.

    https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(21)00115-2/fulltext

    463 (82%) of the 565 participants endorsed self-binding directives, of whom 411 (89%) describing a determinate shift to distorted thinking and decision making when unwell as their key justification. Responses indicating ambivalence (37 [7%) of the 565 responses) were dominated by logistical concerns about the drafting and implementation of self-binding directives, whereas those who rejected self-binding directives (65 [12%] of the 565 responses) cited logistical concerns, validity of their thinking when unwell, and potential contravention of human rights.

    Tania Gergel
    @DrT_Gergel
    ·
    6h

    V important thread on #MAiD / euthanasia in Canada

    Trudo Lemmens
    @TrudoLemmens
    ·
    11h

    1/ Veterans exposed to violence & trauma serving our country are offered suicide via #MAID to solve PTSD… But blame is directed towards individual counsellors, rather than to those who normalized this in law…

    Canada’s shame exposed 1/ @BryanPassifiume

    https://msn.com/en-ca/news/canada/canadian-veterans-were-offered-assisted-suicide-in-five-instances-committee-hears/ar-AA14w6fT?ocid=msedgntp&cvid=f38bb496f4a14be7b27d81d2371b3221

    Canadian veterans were offered assisted suicide in five instances, committee hears

    Story by Bryan Passifiume • Yesterday 11:13 p.m.

    https://nationalpost.com/news/canadian-veterans-assisted-suicide

    ” it was a better alternative to “blowing your brains out.”

    “You’ve called it inappropriate, it’s potentially criminal because you’ve referred it to the RCMP, there is at least one veteran who has lost their life because of this, and you’re telling me that this isn’t grounds to fire this employee?” Richards asked.

    “This employee is still employed at Veterans Affairs? That is completely unacceptable, Minister.”

    Tania Gergel
    @DrT_Gergel

    Replying to @TrudoLemmens and @BryanPassifiume

    Already reaching the bottom of the slippery slope and the new expansion to include mental illness hasn’t even happened yet!

    but ‘SelfBindingDirectives’ are AOK…

  10. In Afghanistan parents are feeding their children anti depressants and anti anxiety meds to stave off hunger and keep them too lethargic to cry The other option is to sell their babies. The cost of an anti depressant is less than a slice of bread. The cess pit of Pharma , worth zillions are doing nothing to aid the population except to make drugs available.

    • Had these reports not been published our trusted and fact-check western main-stream-media, I would not have believed it. Healthcare providers every where else, find it difficult and most often fail, to convince those of the Islamic Faith to take psychiatric drugs.

  11. Mad in America SCIENCE, PSYCHIATRY AND SOCIAL JUSTICE
    Denmark Is the Only European Country Where the Usage of Depression Pills Has Dropped
    By Peter C. Gøtzsche, MD -November 22, 20228
    1680
    Between 2010 and 2020, the consumption of depression pills increased by 37% in 24 European countries. Denmark was the only country where usage dropped (a 4% drop):

    A bar graph depicting countries with their change in consumption of antidepressant drugs. Denmark is at the bottom of the list with a -4% decrease; all others are increases..

    For children, the drop in use in Denmark has been much bigger, a 41% drop in only six years between 2010 and 2016. In Norway and Sweden, usage went up by 40% and 82%, respectively, in the same time period:

    A graph depicting the number of children on depression pills in Denmark, Sweden, and Norway. Denmark shows a steep decline beginning around 2010. Norway and Sweden show steady increases.

    So, what happened in Denmark? Due to concerns about the suicide risk, the Danish National Board of Health reminded family doctors in the summer of 2011 that they should not write prescriptions for depression pills for children, which was a task for psychiatrists.

    At the same time, I began to warn strongly against the suicide risk of the pills. I repeated my warnings countless times in the following years on radio and TV, and in articles, books, and lectures. It started with an interview with the managing director of Lundbeck who, in 2011, claimed that depression pills protect children against suicide. The interview took place while Lundbeck’s US partner, Forest Laboratories, was negotiating compensation with 54 families whose children had committed or attempted suicide under the influence of Lundbeck’s depression pills. I have described Lundbeck’s irresponsible behaviour in my 2015 psychiatry book.

    The huge drop in usage among children occurred against all odds. Even though depression pills cause suicide, indeed at all ages, leading professors of psychiatry in Denmark continued to propagate their false claims that depression pills protect children against suicide, which they continued claiming also after 2016.

    The Danish National Board of Health had issued several warnings against using depression pills to children before 2011. Furthermore, official warnings from authorities have very little impact on prescribing. The average reduction in prescribing is 6%, and interviews with doctors suggest limited awareness, uptake, and at times belief in these warnings. This is exactly the case with depression pills and children. Key opinion leaders among doctors generally do not believe in the warnings; they believe that depression pills protect against suicide, a belief which they propagate everywhere, in scientific articles, in the media and in lectures. This erroneous belief is lethal.

    I am therefore convinced that it is primarily due to my tenacity that the usage went down in Denmark. I say this to encourage people to fight for a good cause, which is that depression pills should not be used by anyone. As I have explained in my Critical Psychiatry Textbook, which will soon be serialised on Mad in America, it is indisputable that depression pills do much more harm than good. Since doctors cannot handle them, they should be taken off the market.

  12. Institute for Scientific Freedom
    Books
    Updated 19 July 2022

    These are the most recent books by Peter C Gøtzsche:

    Critical psychiatry textbook (2022). See just below how to buy it.
    The Chinese virus: Killed millions and scientific freedom (2022). See just below how to buy it.
    The decline and fall of the Cochrane empire (2022). Freely available, see below.
    Mental health survival kit and withdrawal from psychiatric drugs (2022, in 7 languages, see below).
    Vaccines: truth, lies and controversy (2021, with an updated corona chapter)
    Mental health survival kit and withdrawal from psychiatric drugs (2020, now sold as print book, see just above).
    Vaccines: truth, lies and controversy (2020, in 7 languages).
    Survival in an overmedicated world: Find the evidence yourself (2019, in 7 languages).
    Death of a whistleblower and Cochrane’s moral collapse (2019).
    Deadly psychiatry and organised denial (2015, in 9 languages).
    Deadly medicines and organised crime: How big pharma has corrupted health care (2013, in 16 languages). Winner, British Medical Association’s Annual Book Award, Basis of Medicine in 2014.
    Mammography screening: truth, lies and controversy (2012). Winner of the Prescrire Prize in 2012.
    Rational diagnosis and treatment: evidence-based clinical decision-making (2007).
    Drugs That Kill and Organized Crime (2013) and Psychoactive Drugs That Kill and Organized Denial (2015) are now freely available (see bottom of this page).

    Below is a description of some of the books.

    Critical psychiatry textbook (2022)
    My book describes what is wrong with the psychiatry textbooks used by students of medicine and psychology. I read the five most used textbooks in Denmark and uncovered a litany of misleading and erroneous statements about the causes of mental health disorders, if they are genetic, if they can be detected in a brain scan, if they are caused by a chemical imbalance, if psychiatric diagnoses are reliable, and what the benefits and harms are of psychiatric drugs and electroshocks. Much of what is claimed amounts to scientific dishonesty. I also describe fraud and serious manipulations with the data in often cited research. I conclude that biological psychiatry has not led to anything of use, and that psychiatry as a medical specialty is so harmful that it should be disbanded.
    Pdf (234 pages): DKK250 (about €33). See contents. Please wire DKK250, IBAN no. DK5867710005437934, swiftcode LAPNDKK1 (Laegernes Bank, Dirch Passers Allé 76, DK-2000 Frederiksberg) and supply your email address on the transfer, or send it to: pcg AT scientificfreedom.dk. You can avoid the fee for a wire transfer by using my crowdfunding option but remember to supply your email address.

    The Chinese virus: Killed millions and scientific freedom (2022)
    This book documents the US-Chinese cover up for the origin of the COVID-19 pandemic, the worst cover up in the history of medicine, for one of the worst catastrophes ever, which has so far killed 6 million people. It is extremely likely that COVID-19 was caused by a lab leak in Wuhan and that the virus was manufactured there. But China and Beijing’s useful idiots, which include Lancet, Nature, Science, New York Times, US presidential advisor Anthony Fauci, and previous director Francis Collins from the National Institutes of Health, led the whole world astray. All the key players lied about the facts. The book describes many other attacks on scientific freedom and common sense, also outside healthcare, and explains the deplorable role social media censorship has played via their so-called fact checkers.

    Pdf (235 pages): DKK250 (about €33). See contents. Please wire DKK250, IBAN no. DK5867710005437934, swiftcode LAPNDKK1 (Laegernes Bank, Dirch Passers Allé 76, DK-2000 Frederiksberg) and supply your email address on the transfer, or send it to: pcg AT scientificfreedom.dk. You can avoid the often large fee for a wire transfer by using my crowdfunding option.

    The decline and fall of the Cochrane empire (2022)
    This is the story about institutional corruption and the rapid transformation of a prosperous democracy into a brutal tyranny. It explains why one of the most important organisations ever in healthcare, the Cochrane Collaboration, now seems to be doomed because the wrong man was employed as CEO in 2012. He systematically destroyed Cochrane, particularly the highly respected Cochrane centres, and a weak Governing Board let him do it. In April 2021, he suddenly left without a farewell message, seven days before the UK funder announced a major budget cut. Many of the things he did were highly bizarre and difficult to understand. Journalists have therefore asked: Did he have powerful friends in the drug industry? Was he planted to destroy Cochrane?
    Download for free

    Mental health survival kit and withdrawal from psychiatric drugs (2022)
    This book will help people with mental health issues survive and come back to a normal life. The general public believes that drugs against depression and psychosis and admission to a psychiatric ward are more often harmful than beneficial, and this is also what the science shows. Even so, most people continue taking psychiatric drugs for many years. This is mainly because they have developed drug dependence. The psychiatrists and other doctors have made hundreds of millions of people dependent on psychiatric drugs and yet have done virtually nothing to find out how to help them come off them safely again, which can be very difficult. The book explains in detail how harmful psychiatric drugs are and tells people how they can withdraw safely from them. It also advises about how people with mental health issues may avoid becoming psychiatric “career” patients and lose 10 or 15 years of their life to psychiatry.

    Buy here. See Contents here

    Mental survival kit and withdrawal from psychoactive drugs (2020)
    This book can help people with mental health problems to survive and return to a normal life. Citizens believe that medication for depression and psychosis and admission to a psychiatric ward are more often harmful than beneficial, and this is also what science shows. Yet most patients continue to take psychotropic drugs for many years. This is mainly because they have developed drug addiction. Psychiatrists and other doctors have addicted hundreds of millions of people to psychoactive drugs and yet have done virtually nothing to figure out how to help them safely come off again, which can be very difficult. The book explains in detail how harmful psychotropic drugs are and tells how to stop using them. It also provides advice on

    See the table of contents here (on MIA) .

    Pdf edition (217 pages): Transfer DKK 150 (incl. VAT) to the Institute for Scientific Freedom, account 67715437934 (Lægernes Bank), and write your e-mail address in the note field. As there may not be room for the entire address, also send an email to pcg@scientificfreedom.dk
    Printed book (217 pages, Dispuks publishing house): DKK 249.95. Can be bought here . Press release

    Mental health survival kit
    and psychiatric medication withdrawal
    This book will help people with mental health problems survive and return to normal life. The general public believes that medication for depression and psychosis and admission to a psychiatric ward are more often harmful than beneficial, and this is also what the science shows. Even so, most people continue to take psychiatric drugs for many years. This is mainly because they have developed drug addiction. Psychiatrists and other doctors have made hundreds of millions of people dependent on psychiatric drugs and yet they have done virtually nothing to figure out how to help them get off them safely, which can be very difficult. The book explains in detail how harmful psychiatric drugs are and tells people how they can safely withdraw from them.
    PDF edition (242 pages): DKK150 (about €20).

    Please: transfer DKK150 using IBAN account number DK5867710005437934 with swift code LAPNDKK1 (Laegernes Bank). Write your email address in the message field. If applicable, account holder is: Peter Gøtzsche, bank address: Dirch Passers Allé 76, DK-2000 Frederiksberg

    Survival kit for mental health and withdrawal of psychotropic drugs
    This book will help people with mental health problems to survive and return to a normal life. The general population is convinced that drugs against depression or psychosis and admissions to psychiatric units are more often harmful than beneficial, and this is also what science shows. Even so, most people continue to take psychiatric medications for many years. This is mainly because they have developed a dependency on these substances. Psychiatrists and other doctors have contributed to hundreds of millions of people dependent on psychiatric medications, and yet have done virtually nothing to figure out how to help them safely come off, which can be very difficult. The book explains in detail how harmful psychiatric medications are and teaches the public how they can be safely withdrawn. It also reports on how people with mental health problems can avoid becoming labeled psychiatric patients for life and losing 10-15 years of their life to psychiatry.
    PDF edition (234 pages): DKK150 (about €20).

    Please: Transfer DKK150 using IBAN account number DK5867710005437934 with swiftcode LAPNDKK1 (Laegernes Bank). Type your email address in the message field. If necessary, the account holder is: Peter Gøtzsche, bank address: Dirch Passers Allé 76, DK-2000 Frederiksberg

    Mental Health Survival Kit and Withdrawal
    from Psychiatric Drugs
    This book will help people with mental health issues to survive and return to normal life. The general public believes that medications for depression and psychosis and admission to a psychiatric ward are more often harmful than beneficial, and this is also what science shows. Despite this, most people continue to take psychiatric drugs for many years. This is mainly because they have developed an addiction to the drug. Psychiatrists and other doctors have made hundreds of millions of people addicted to psychiatric drugs and yet they have done next to nothing to discover how to help people get off drugs safely, which can be very difficult. The book explains in detail how harmful psychiatric drugs are and tells people how to safely withdraw from them. He also gives advice so that people with mental health problems manage to avoid becoming “career” psychiatric patients and not lose 10 or 15 years of their life because of psychiatry.
    Edition Pdf (249 pages) : 150 DKK (environ 20 €).
    To order, please transfer 150 DKK using IBAN account number: DK5867710005437934 with swift code: LAPNDKK1 (Laegernes Bank). Write your email address in the message field. If required, the account holder is: Peter Gøtzsche, bank address: Dirch Passers Allé 76, DK-2000 Frederiksberg

    Survival kit for psychiatry and
    weaning off psychiatric drugs
    The general public believes that drugs for depression and psychosis do more harm than good, as do admissions to psychiatric wards or institutions. And that is true, according to scientific research. Yet many take medication for mental disorders for many years. This is mainly because they can no longer stop. Hundreds of millions of people have become dependent on psychotropic drugs from psychiatrists and other doctors. In this book, leading expert Peter C. Gøtzsche explains how harmful these drugs are and how people can safely stop taking them. He also advises people with psychological problems on how to prevent them from remaining a patient for a long time.

    Walburg Press. Number of pages: 278. Order this book € 24.99

    Drugs that kill and organized crime
    The Spanish translation of my book “Deady medicines and organized crime” is now freely available.
    you can download it here

    Psychotropic drugs that kill and organized denial
    The Spanish translation of my book “Deady psychiatry and organized denial” is now freely available.
    you can download it here

  13. This has the Edge…

    The Perfect Killing Machine

    Somewhat like a lobster being slowly boiled as opposed to one dropped straight into boiling water, we have learned to co-exist with and ignore a Perfect Killing Machine in our midst which takes far more lives than the Covid pandemic – without it featuring anywhere in the news.

    https://davidhealy.org/the-perfect-killing-machine/

    2,377 views 17 Apr 2020

    Almost all regulators and government health officials and guideline makers – Sir this and Lady that – know that the literature on medicines is almost completely ghost-written and dangerous. But they say its not their job to police this problem. This is what killed Stephen O’Neill – its time for the nobles to act nobly or perhaps that should be gallantly.

    https://www.youtube.com/watch?v=2RnPN0pAbX8

    There is nothing better than a Solid-Case, a Clear Description, a Prescription, and eight minutes of Sheer Clarity on behalf of Stephen O’Neill whose death was precipitated by Sertraline.

    Rock-Solid for Stephen…

  14. Intended for healthcare professionals

    Toggle navigation
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    Opinion
    When I use a word . . . . Too little healthcare—coroners’ concerns
    BMJ 2022; 379 doi: https://doi.org/10.1136/bmj.o2873 (Published 25 November 2022)
    Cite this as: BMJ 2022;379:o2873

    Jeffrey K Aronson
    In England and Wales, coroners are legally required to send reports to interested parties when they believe that actions should be taken to prevent deaths other than those on which their conclusions are based. These reports are known as Coroners’ Reports to Prevent Future Deaths (PFDs), and they are mandated under paragraph 7 of schedule 5 of the Coroners and Justice Act 2009, and regulations 28 and 29 of the Coroners (Investigations) Regulations 2013, previously having been described as Rule 43 reports. Individuals or organisations that receive a PFD are statutorily required to respond to the coroner within 56 days of receiving the report, outlining actions proposed or already taken to tackle the concerns that the coroner has expressed.
    Since 2013, 19% of 3785 PFDs have reported deaths associated with medicines, with opioids (22%), antidepressants (9.7%), and hypnotics (9.2%) being most commonly involved.1 Concerns that coroners expressed about these deaths often related to patient safety (29%) and communication (26%), including failures of monitoring (10%) and poor communication between organisations (7.5%).
    Yet coroners received responses to only 49% of these medicines-related PFDs, suggesting that too little attention is being paid to their reports. Opportunities to avoid future deaths may therefore be being missed. This implies too little healthcare.

    Too much or too little?
    In recent columns I have been exploring areas of healthcare in which one can have too much of a good thing—too much healthcare,2 or, as some have it, too much medicine.3

    The topics have included overdetection,4 overdefinition,5 overdiagnosis,6 technology,7 overconfidence,8 underconfidence,9 self-assessment,10 incompetence,11 biomarkers,12 monitoring,13 and observational studies.14 Other topics await exploration.

    Yet there are also areas in which we have too little healthcare. I am not referring to the fact that we have too few healthcare practitioners, overlong waiting lists, and longer waiting times for ambulances and clinics, among many deficiencies of service provision in the NHS, but to areas of healthcare that are being neglected.

    Preventing future deaths
    In England and Wales, coroners are legally required to send reports to interested parties when they believe that actions should be taken to prevent deaths other than those on which their conclusions are based. These reports are known as Coroners’ Reports to Prevent Future Deaths (PFDs), and they are mandated under paragraph 7 of schedule 5 of the Coroners and Justice Act 2009, and regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. Individuals or organisations that receive a PFD are statutorily required to respond to the coroner within 56 days of receiving the report, outlining actions proposed or already taken to tackle the concerns that the coroner has expressed.

    Rule 43
    Originally, reports of this kind were issued under Rule 43, “Prevention of similar fatalities,” as stated in the Coroners Rules 1984.15 Rule 43 stated that “A coroner who believes that action should be taken to prevent the recurrence of fatalities similar to that in respect of which the inquest is being held may announce at the inquest that he [sic] is reporting the matter in writing to the person or authority who may have power to take such action and he may report the matter accordingly.” Note the use of the word “may.”

    In 2008, Rule 43 was amended under the Coroners (Amendment) Rules,16 as follows:

    For rule 43 substitute—

    “Prevention of future deaths

    Where—

    (a) a coroner is holding an inquest into a person’s death;

    (b) the evidence gives rise to a concern that circumstances creating a risk of other deaths will occur, or will continue to exist, in the future; and

    (c) in the coroner’s opinion, action should be taken to prevent the occurrence or continuation of such circumstances, or to eliminate or reduce the risk of death created by such circumstances,

    the coroner may report the circumstances to a person who the coroner believes may have power to take such action.”

    Coroners were required to send a copy of the report to, among others, the Lord Chancellor; and “to any person who the Lord Chancellor believes may find it useful or of interest.”

    Furthermore, anyone to whom the coroner sent a report was required to “give the coroner a written response to the report, containing:

    (a) details of any action that has been taken or which it is proposed will be taken whether in response to the report or otherwise; or

    (b) an explanation as to why no action is proposed within the period of 56 days beginning with the day on which the report is sent.”

    Later amendments
    Further changes were later made under the Coroners and Justice Act 200917 and the Coroners (Investigations) Regulations, 2013.18 The newer provisions were essentially the same as before, but the Lord Chancellor was replaced by the Chief Coroner, since responsibility for the reports was transferred from the Ministry of Justice to the Chief Coroner’s office in April 2013.19 Furthermore, the requirement that the report should deal only with cases similar to those detailed in the report was dropped.

    Although the reports are known as Prevent Future Deaths (PFDs) and are referred to as such in most documents, the 2013 regulations referred to them as “Action[s] to prevent other deaths.” The main features are that a report should be issued when:

    “anything revealed by the investigation gives rise to a concern that circumstances creating a risk of other deaths will occur, or will continue to exist, in the future, and

    “in the coroner’s opinion, action should be taken to prevent the occurrence or continuation of such circumstances, or to eliminate or reduce the risk of death created by such circumstances, the coroner must report the matter to a person who the coroner believes may have power to take such action.”

    A written response is required by law within 56 days, and copies of the report and of the response to it must be sent to the Chief Coroner.

    Since 2013 copies of the reports and the responses to them have been posted on the Courts and Tribunals Judiciary website.20 They are also available through the Preventable Deaths Tracker.21

    Two examples
    Here are two illustrative cases.

    A coroner issued a PFD after a patient died from clozapine toxicity, writing that “it appears that many staff are not aware of the significance of [clozapine] particularly when considering potential side-effects and warning signs of deterioration.”22

    A PFD was issued after a woman died of uterine rupture, having been given misoprostol, to induce labour after an intrauterine death, in doses in excess of the national guidelines of the Royal College of Obstetricians and Gynaecologists.23 In her PFD, the coroner noted that the hospital had subsequently changed its protocol for administering misoprostol but “has not yet taken any steps to ensure that there is learning at a national level of the increased risk of rupture in a multigravida mother.” She did not, however, send a copy of the PFD to the royal college.

    Frequency of medicines-related PFDs
    Cases of this kind are not unusual. When they reviewed the records of 3277 corners’ inquests for 1986–91, Ferner and Whittington found 10 deaths that had been identified as being due to errors in prescribing or giving drugs and 36 deaths caused by adverse drug reactions.24 Ferner and colleagues later surveyed 500 PFDs and identified 99 reports (100 deaths) in which medicines or a part of the medication process or both were mentioned.25

    Since 2013, 19% of 3785 PFDs have reported deaths associated with medicines, with opioids (22%), antidepressants (9.7%), and hypnotics (9.2%) being most commonly involved.1 Concerns that coroners expressed often related to patient safety (29%) and communication (26%), including failures of monitoring (10%) and poor communication between organisations (7.5%).

    Yet coroners received responses to only 49% of these medicines-related PFDs, suggesting that too little attention is being paid to their reports. Opportunities to avoid future deaths may therefore be being missed. This implies too little healthcare in this area.

  15. ‘If you have thoughts on how to improve the drug regulatory system, then please leave comments below.’

    Inbox
    Maryanne Demasi, PhD from Maryanne Demasi, reports
    3:35 AM (45 minutes ago)

    My recent talk in Copenhagen
    Failure of drug regulation; declining standards and institutional corruption
    MARYANNE DEMASI, PHD
    NOV 29

    At the conference L to R: Leemon McHenry, David Hammerstein, John Ioannidis, Peter Gøtzsche, Maryanne Demasi, Michael Baum, Kim Witczak
    Recently, I presented a talk in Copenhagen, Denmark, titled, “Failure of Drug Regulation: Declining standards and institutional corruption”

    It was hosted by the the Centre for Evidence-Based Medicine (CEBM), Oxford and the Institute for Scientific Freedom, Denmark.
    SLIDES below:

    “Safe and effective” is a phrase adopted by drug regulators to assure the public that the pills we reach for in our medicine cabinets, or the vaccines injected into our arms, have proven benefits that outweigh the risks. And we assume this is based on a rigorous, independent assessment of the trial data. But the information I will present today, demonstrates that drug regulators have fallen victim to institutional corruption and have often violated their sworn oath to protect public health.

    My recent investigation for The BMJ analysed six major international drug regulators, comparing aspects such as conflicts of interest, proportion of industry funding, transparency of data and drug approval pathways.

    A summary of what I found is in Table 1. Notably, you will see in the top row, that all the major drug regulators are largely funded by the very industries they are sworn to regulate, with the Australian TGA receiving 96% of its funds from the drug industry. In this talk, however, I will focus on the US FDA, because it is the most well-funded, well-resourced regulator in the world, and low to middle income countries look to the FDA for regulatory decisions.

    Following the HIV/AIDS crisis in the 80s there was concern, especially from advocacy groups, that it was taking too long to get drugs to market. US Congress passed the 1992 Prescription Drug User Fee Act allowing the FDA to accept industry funding. Fees increased 30-fold from $29m in 1993 to $884m in 2016. Now, 65% of funding for drug evaluation comes from industry fees. The FDA hired more staff so that it could speed up approvals. It worked. In 1988, only 4% of drugs introduced onto the market were approved first by the FDA, but that rose to 66% by 1998 after its funding structure changed.

    Now, 68% of drugs approved by the FDA are via expedited pathways. Advocacy groups are especially pleased because it means that people gain faster access to medicines. The downside however, is that expedited approvals require a lower burden of proof.

    One example is how the FDA accepts changes in a ‘surrogate marker’ rather than a ‘clinical outcome.’ The drug Aducanabab for Alzheimers was approved on the basis of lowered beta-amyloid proteins, without any meaningful improvement to the patients symptoms.

    It means drug companies require fewer, smaller, less robust trials to get their drugs into the marketplace.

    The FDA also allows drugs onto the market before efficacy has been proven, on the condition that drug companies perform “confirmatory trials”. However, these trials are often not carried out, or they take years to show the drug doesn’t work, all the while, the drug is being sold on the market under the pretense of ‘safe and effective.’

    Consequently, drugs approved via expedited pathways, are more likely to be withdrawn for safety reasons or have black box warnings.

    During the drug approval process, the FDA convenes advisory panels to provide insight and credibility to the decision-making process. But a recent analysis shows that the FDA is seeking this independent advice, less frequently. In 2010, 55% of drug approvals were reviewed by advisory panels, but in 2021, that dropped to just 6%.

    The FDA conducts random inspections of clinical trial sites to ensures the integrity of data from those trials. If there are any violations or objectional practices, the FDA writes up an inspection report. The reports are not proactively shared with the public, and often, details are only obtained by filing an FOIA request. FOIAs can take several months to be processed, and reports end up highly redacted, and of limited value (as shown on the slide).

    In 2007, the Office of Inspector General determined that the FDA only conducted inspections at 1% of trial sites and there was no database for how many sites were operating across the US and abroad. The FDA says it doesn’t know how many trial sites are operating and that keeping track of them all is ‘too resource intensive.’

    During the pandemic, things went from bad to worse for the FDA. While vaccine manufacturers ramped up their operations, the restrictions meant that the FDA’s onsite inspections of trial sites ground to a halt for a period of time. Regulatory documents show that the FDA only inspected 9 in 153 trial sites for Pfizer and 1 in 99 sties for Moderna [CORRECTION: only 1 site was inspected for prior to full approval, but 9 were inspected for EUA, making a total of 10 sites]

    Notably, a whistle-blower named Brook Jackson, lodged a complaint with the FDA about falsified data at three of Pfizer’s mRNA trial sites, based in Texas. She was the regional director at the three trial sites and witnessed falsification of data, the unblinding of patients, and inadequately trained vaccinators who failed to follow up on adverse events. Alarmingly, the FDA never conducted an onsite inspection of those sites after Jackson’s complaint.

    It is clear that the FDA’s evidentiary standards have declined over the decades. The agency relies heavily on drug industry money, which has led to faster drug approvals but the drugs are more unsafe. The FDA is relying less on its external advisory committees when approving drugs and its no secret that the agency has endured enormous pressure from the White house during the pandemic. Not just from the Trump administration, but from the Biden Administration too. Top vaccine officials, Marion Gruber and Philip Krause resigned in October last year, after Biden pushed a widespread booster roll out in spite of the evidence. A Government accountability report this year revealed that staffers at the agency were under enormous political pressure, which they say, resulted in the “suppression of scientific findings” regarding covid-19.

    Reform is tricky – some suggest incremental improvements in transparency of data and conflicts of interest. Others suggest there needs to be an independent body assessing the FDA’s drug approval decisions. It has also been suggested that the FDA needs a major overhaul, that the agency needs to ‘clean house’ and rid itself of bureaucrats who are simply biding their time until retirement. There are no clear answers but most of the people I interviewed over the last few months agree that the agency is “broken”.

    If you have thoughts on how to improve the drug regulatory system, then please leave comments below.

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  16. Preventable Deaths Tracker

    A platform to explore concerns raised by coroners to prevent future deathsMENU

    Preventable Deaths Database
    SUBMENU
    Dissemination
    Preventable Deaths Tracker
    A platform to explore concerns raised by coroners to prevent future deaths
    In August 2021, the WHO published the Global Patient Safety Action Plan (2021-2030) to eliminate avoidable harms in healthcare. In England and Wales, legislation is in place to capture information on preventable deaths. Yet little is being done to use this information to reduce premature deaths.

    We have created the Preventable Deaths Tracker to collate this information and make it accessible for all. Our Tracker also shares systematic analyses of this information, to warn against repeat hazards and highlight important lessons, to improve public safety, reduce avoidable harms, and prevent premature deaths.

    What’s in the Database?
    As of 22 June 2022, the Courts and Tribunals Judiciary had uploaded 4001 Prevention of Future Deaths reports (PFDs). The graph below illustrates the number of PFDs published over time. You can see the latest individual data here.
    ……..
    Number of Prevention of Future Deaths reports (PFDs) published on the Courts and Tribunals Judiciary website from inception (July 2013) to 22nd June 2022.

    Richards, GC. Preventable Deaths Tracker. 2022. https://preventabledeathstracker.net/

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