Sex, Drugs and a Leap Year Proposal

January, 25, 2021 | 13 Comments


  1. One trick pony –

    Look before you Leap…

    Boeing 737 Max cleared to fly again ‘too early’

    Regulators in the US and Europe insist their reviews have been thorough, and that the 737 Max aircraft is now safe.

    In his report, Mr Pierson claims that regulators and investigators have largely ignored factors, which he believes, may have played a direct role in the accidents.

    Investigators believe both accidents were triggered by the failure of a single sensor. It sent inaccurate data to a piece of flight control software, called MCAS.

    “Boeing and the Federal Aviation Administration (FAA) must finally become more transparent, and begin to provide information and data, so that independent experts can determine the worthiness of the work that’s been done.”

    Howeverm he adds that “taking the limited information in any accident report… and making fresh interpretations of it, is not the same as conducting a new investigation”.

    Boeing itself will not comment on whether the electrical and flight control problems highlighted by Mr Pierson may have played a factor in the two accidents, on the grounds that this is a matter for the investigating authorities.

    But relatives of those who died aboard ET302 are continuing to urge the agency not to allow the 737 Max to operate in Europe, “until continuing concerns about the aircraft’s safety have been fully and openly addressed”.

    Boeing’s $2.5BILLION payout for 737 MAX crashes: Aviation firm is ordered to pay $1.4million to EACH family of the 346 people killed in two airline disasters and $1.7billion to airlines who purchased the planes

    Prosecutors described Boeing’s failings in withering terms, accusing the company of putting ‘profit over candor’ and of engaging in a ‘half-truths’ and a ‘cover up.’

    Cleared to fly …

  2. ….”hide behind risk benefit mumbo-jumbo, which, deployed in sonorous tones like the Wizard of Oz once used, they hope will stop awkward questions.”

    Just brilliant.
    This can be applied to most of what pdocs are feeding patients these days.

    Thanks for all you do and are doing Dr Healy.

  3. Ugh the whole Risk Benefit argument drives me nuts. Who determines this number? Is there a percentage thats decideds? If 99% of the people that take these drugs benefit and 1% will experience permanent life destroying side effects than its ok for the market.

    I would personally like to see these Governments that have somewhat recognized PSSD Have a press release and national ad campaign warning about it. The way Health Canada basically said ok we’re aware of it and continue to monitor it in the future. No fuck heads you need to warn Canadians of this and reassess the safety of these. Not just sit back and wait for more people’s lives to be destroyed before taking it seriously.

    • Risk Benefit appeared in the early 1990s and scored big in the defense of Prozac in 1991. Pharma persuaded regulators that the RCT data provided the perfect cover for them to justify approving a drug and continuing to keep it on the market despite thousands of people being injured and killed. No journalist or academic would be able to argue without seeming irrational


  4. With reference to next weeks post on sex drugs and suicides , there is a load of research published and being called for by International Association for Suicide Prevention (IASP) It would be surprising if there aren’t more people who suffer from PSSD dying of suicide or who are contemplating suicide as a result of the restrictions imposed by Covid. And they have compiled huge amounts of information which could be useful by this org. depending on how they use it – or not- of course.

    There is nothing in the guidelines of this organisation to suggest they even admit SSRI;s and other drugs can be a factor When suicide could be exacerbated by Covid
    this sis a serious ommission

    Responding to global suicide-related risk arising from the COVID-19 pandemic
    Statement from the Executive Committee of the International Association for Suicide Prevention.
    On 11 March 2020, the WHO declared the COVID-19 virus a global pandemic. ………

    However, evidence relating to previous public health emergencies, while limited, gives reason for concern.
    Deaths by suicide increased in the USA during the 1918–19 influenza pandemic (Wasserman 1992), and studies on
    Severe Acute Respiratory Syndrome (SARS) found an increase of suicide among the elderly (Cheung et al, 2008; Yip et
    al, 2010, Chan et al, 2006), associated with social disengagement, mental stress, anxiety, and fears of being a burden
    on the family. Recent informed commentaries suggest that the COVID-19 pandemic may lead to an increase in suicidal
    behaviour due to the development or exacerbation of known risk factors for self-harm such as mental ill-health, social
    isolation, entrapment, grieving, loneliness, hopelessness, unresolved anger, stigma, unemployment, financial strain,
    domestic violence, and excessive alcohol consumption (Holmes et al, 2020; Gunnell et al, 2020)………..

    The IASP urgently needs your help to develop and implement a strategic plan to
    reduce COVID-19-related suicidal behaviour. We call upon you to work in collaboration with the IASP, sharing research
    and other evidence from your country about the impact of the pandemic on suicidal behaviour so that we can collectively
    integrate sources of key information and insights from your membership, from external stakeholders and, wherever
    possible, from governments.
    IASP is building a central pool of resources (expertise, research, guidelines for good practice)

    The intention is to shut down certain aspects of reporting, some ‘advice’ reasonable enough maybe……but if people from the PSSD ‘community’ report – it would be interesting to see their response..
    ‘We call upon you to work in collaboration with the IASP, sharing research and other evidence from your country about the impact of the pandemic on suicidal behaviour so that we can collectively integrate sources of key information and insights from your membership, from external stakeholders and, wherever possible, from governments.’…
    Read the entire statement here.

    COVID-19 Suicide Research Studies
    To share and inform on studies and research being undertaken in respect of suicide prevention and COVID-19, details of such studies are being collated and compiled in the directory below.

    If you are running a relevant study please use the button below to share your study details.

    Click here to submit a research study
    You will find below a curated selection of research and publications related to suicide, suicide prevention and COVID-19. View the IASP Newsletter for further research and publication news beyond COVID-19.

    The impact of the COVID-19 pandemic on self-harm and suicidal behaviour: a living systematic review. Given the likely rapidly expanding research evidence base on the pandemic’s impact on rates of suicide, suicidal behaviours and self-harm and emerging evidence about how best to mitigate such effects, it is important that the best available knowledge is made readily available to policymakers, public health specialists and clinicians as soon as is possible. To facilitate this, we are conducting a living systematic review focusing on suicide prevention in relation to COVID-19. Daily automated searches will feed into a web-based screening system. Following initial screening, articles will be reviewed daily by suicide prevention experts in our team. Key publications and evidence summaries will be shared with policy makers in the UK, Ireland and Internationally. The review is jointly lead by researchers from the University of Bristol and Swansea University. It is a collaborative effort involving colleagues from the Universities of Cork, Oxford, Manchester, Glasgow, and Ulster.

    (Note the ‘initial screening by ‘experts’ – they are not listed – would be interesting to see who they block)
    COVID-19 Suicide Research Studies Register
    Register your COVID-19 Suicide Research Study

    Please use the fields below to register and provide information on the study you are involved in. Once you have submitted your study you will receive an email confirmation. The directory itself is updated weekly.

  5. I think NICE uses Qualys to draw up some of their quidelines. Another weird concept unless individuals are involved in making their preferences count

  6. Benefits and risks of drugs: a wrong concept

    EMA’s executive director Guido Rasi writes in a letter from 26 February 2020 to psychiatrist David Healy that, “In line with current legislative requirements, EMA’s role is to establish full benefit-risk analyses for medicines.”

    Healy replies that drug regulators, other institutions like NICE and politicians “hide behind risk benefit mumbo-jumbo, which, deployed in sonorous tones like the Wizard of Oz once used, they hope will stop awkward questions.”

    The terminology is misleading, as it implies that drugs always have benefits but not necessarily have any harms, only risks of harms. It is the other way around. Drugs always cause harm and sometimes they also cause benefits.

    Thus, a more appropriate terminology would be possible benefits and certain harms, and since the harms are certain, they should be flagged first: certain harms and possible benefits.

    Many years ago, I advocated for a change in terminology, both in CONSORT (which John Ioannidis also did) and Cochrane, and this was accepted so that at least some people now ask the more appropriate question: What is the balance between benefits and harms?

    Unfortunately, many people – undoubtedly “inspired” by industry – use the illusive construct benefit-harm ratio, which can only exist if benefits and harms are measured on the same scale, e.g. total mortality, which is very rarely the case. In all other cases, it will be subjective and arbitrary what people think of the balance between benefits and harms according to the values they attach to various outcomes and how common they are.

    • Trying to weigh up all the factors to come to a desicion can be very complicated especially if one of the factors is persuation by others to take (or not) a drug. Years ago on a course I was shown a decision aid which could simplify decisions to some extent by writing down the various factors on a ‘decision tree’ and attaching a weight for difference preferences. I have never heard of it actually being used but it is horrendously difficult to keep all the factors/possibilities in our heads – are they a good idea – if they were to be used of course?

  7. Pick a Pocket or Two …

    ‘since the harms are certain, they should be flagged first’

    ‘Watchful Waiting’

    “These are the methods of the mob.”

    Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Health Care

    “How come we have allowed drug companies to lie so much, commit habitual crime and kill hundreds of thousands of patients, and yet we do nothing? Why don’t we put those responsible in jail? Why are many people still against allowing citizens to get access to all the raw data from all clinical trials and why are they against scrapping the whole system and only allow publicly employed academics to test drugs in patients, independently of the drug industry?

    “I know some excellent psychiatrists who help their patients a lot, e.g; David Healy uses watchful waiting before giving drugs to first-episode patients. I also know that some drugs can be helpful sometimes for some patients. And I am not ‘antipsychiatry’ in any way. But my studies in this area lead me to a very uncomfortable conclusion:

    “Our citizens would be far better off if we removed all the psychotropic drugs from the market, as doctors are unable to handle them. It is inescapable that their availability creates more harm than good.”

    Richard Smith, Former Editor-in-Chief of the British Medical Journal, reviews Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare
    “Most of Peter’s book is devoted to building up the case that the drug industry has systematically corrupted science to play up the benefits and play down the harms of their drugs.

    “As an epidemiologist with very high numerical literacy and a passion for detail, so that he is a world leader in critiquing clinical studies, Peter is here on very solid ground. He joins many others, including former editors of the New England Journal of Medicine, in showing this corruption.

    “He shows too how the industry has bought doctors, academics, journals, professional and patient organisations, university departments, journalists, regulators,  and politicians.
    “These are the methods of the mob.”

    Dr. Gotzsche says there’s no legitimate reason for doctors to prescribe antidepressants and many other psychiatric drugs to their patients. He says the drugs would have to incur “colossal” benefits to justify their use, given their terrible and toxic safety profiles.

    But those “colossal” benefits just don’t exist.

    Did regulators fail over selective serotonin reuptake inhibitors?

    GlaxoSmithKline’s recent letter to doctors points to a sixfold increase in risk of suicidal behaviour in adults taking paroxetine.1 This contrasts with the data in the UK Medicines and Healthcare Products Regulatory Authority’s expert working group report on suicide and antidepressants published in December 2004.2 Many people expect drug companies to be slow to concede that a drug causes hazards, but we do not expect our regulators to be even slower, so any hint that this might have been the case needs to be examined.

    Regulatory problem

    In February 1990 an article raised concerns that the recently licensed fluoxetine might trigger suicide acts in depressed patients.3 A series of meta-analyses of published and unpublished antidepressant trials subsequently failed to show benefit in terms of suicidal acts with active treatment compared with placebo.4–9 In fact, each analysis showed a small excess risk with active treatment for all classes of antidepressants, although the increases are compatible with chance and the original authors concluded there were no differences. For much of the 1990s campaigners were saying trials with placebo controls in depression were unethical, and these analyses were attempts to justify placebo controlled trials.

    I recently participated in a cumulative meta-analysis of published trials that found an excess of suicide attempts in patients taking selective serotonin reuptake inhibitors (SSRIs) compared with those taking placebo.10 The numbers in the individual trials are small, so that although from 1988 onwards the point estimate indicates roughly a doubling of the risks of suicidal acts with SSRIs, the effect has only recently been consistently significant. Nevertheless, the trend should have been seen by both companies and regulators as something that required investigation before …

    Analysis and Comment

    “This failure, along with an apparent selection of data, and flouting
    of basic scientific norms, can only deepen the questions hanging over
    regulatory involvement in this issue.”

    Kent Woods
    Chief Executive, MHRA

    Healy’s article ‘Did regulators fail over selective
    serotonin reuptake inhibitors’ makes allegations about failure of MHRA to
    warn about suicidal behaviour with SSRIs which require response1.
    The MHRA moved swiftly …

    ‘since the harms are certain, they should be flagged first’ …

  8. With thanks to the H H C which has published this book and so much else to reveal and publish – on similar lines to Samizdat Health
    The Hidden History Center is a project of the Museum of Hidden History, a 501(c)(3) non-profit, established in Washington D.C. in April 2012.

    What we do not see because of our assumptions and mis-education
    What we cannot see because of our paradigms and lack of counter-narratives
    What we are not allowed to see by the National Security State
    At the Center, we will present narratives of the U.S. historical record that you’ve never heard – secrets about powerful figures, operations performed under the radar, and actions hidden from the public, that changed our country.

    The Zyprexa Papers: Big Pharma Meets Big Diagnosis, Big Courts, and Big Psychiatric Hospitals
    This book chronicles the battles on behalf of Bill Bigley, the psychiatric patient whose ordeal by Eli Lilly’s product made possible the exposure of the Zyprexa Papers. Written by James B. Gottstein, Esq. and published in 2020, The Zyprexa Papers are crucial documents in the fight to hold Eli Lilly accountable for hiding harm caused by Zyprexa and their illegal marketing of it.

    It was just a normal day before Dr. David Egilman called me out of the blue on November 28, 2006. The days are short that time of year in Anchorage, Alaska, and it was getting dark by mid-afternoon. Dr. Egilman told me he had been hired as an expert witness by one of the law firms representing patients who had taken Zyprexa and contracted diabetes or other metabolic problems. He wanted to know about documents relating to Zyprexa I might have. In truth, he was feeling me out to see whether I might be willing to subpoena him, so he could legally send me secret documents. These documents revealed the pharmaceutical company Eli Lilly (Lilly) had from the beginning suppressed information showing Zyprexa caused these life-threatening conditions. In addition, they showed Lilly had illegally marketed this powerful and dangerous drug for use in children and the elderly. He wanted me to then send them to Alex Berenson, a reporter for The New York Times with whom he was already working on a Zyprexa exposé.

    On December 17, 2006, The New York Times began a series of front-page stories about documents obtained from Alaska lawyer Jim Gottstein, showing Eli Lilly had concealed that its top-selling drug caused diabetes and other life-shortening metabolic problems. The “Zyprexa Papers,” as they came to be known, also showed Eli Lilly was illegally promoting the use of Zyprexa on children and the elderly, with particularly lethal effects. Although Mr. Gottstein believes he obtained the Zyprexa Papers legally, the United States District Court for the Eastern District of New York in Brooklyn decided he had conspired to steal the documents, and Eli Lilly threatened Mr. Gottstein with criminal contempt charges. In The Zyprexa Papers, Mr. Gottstein gives a riveting first-hand account of what really happened, including new details about how a small group of psychiatric survivors spread the Zyprexa Papers on the Internet untraceably. All of this within a gripping, plain-language explanation of complex legal maneuvering and his battles on behalf of Bill Bigley, the psychiatric patient whose ordeal made possible the exposure of the Zyprexa Papers.

    Bill Bigley (25 Apr 2012)


    Heroes and Villains Populate the Pages of The Zyprexa Papers, by Susan Rogers, Key Update, May 18, 2020.
    “The Zyprexa Papers” is a deep dive into the Bizarro World of psychiatry, Big Pharma, and the judicial system. As Jim writes, “To me, it is crystal clear locking people up and drugging them against their will is not ‘for their own good’ but instead very harmful to them. One of my goals in writing this book is to show this truth.” Mission accomplished.

    David Healy, MD, Review on Samizdat Health Writer’s Co-operative, March 21, 2020.
    This much is well-known. The papers have been widely distributed and have opened some peoples’ eyes. Gottstein doesn’t detail the content of these papers — what every non-person knew about the capacity of these drugs to cause diabetes, metabolic syndrome, suicidality and other problems. The fascination lies in how little of this appears to be known by the psychiatrists who might lock you and me up and inflict treatment on us and how pharma takes psychiatrists for idiots.

    It’s rather like how little Germans during World War II knew about what was happening in their country. And just like German functionaries drew up specifications for drainage in vehicles to transport people to concentration camps, much as they would have done for transporting animals, so also Judge Weinstein dealing with Gottstein’s actions stuck rigidly to the legal specifications without questioning what in fact was going on. And if that sounds grimly American, everything we know about what pharma gets up to comes from legal actions in the US and a handful of lawyers like Gottstein. The rest of the world has made no contribution to what we now know.

    Many people coming to this book might figure that the Bigley saga plays second fiddle to what is after all called The Zyprexa Papers. A switch from the dizzying heights of New York courtroom drama to an Alaskan backwater. But Bill Bigley’s case is the beating heart of this book. The Zyprexa papers are the bait for Gottstein’s masterly portrayal of how the system treated Bill and will treat you and anyone you know who comes into contact with it.

  9. Pathways to Suicide One of the most obvious questions has just not been included . Which if any ,medications had been prescribed.

    HomeJournalsBJPsych OpenVolume 7 Issue 1
    First-person accounts of the processes and planning involved in a suicide attempt on the railway
    Published online by Cambridge University Press: 20 January 2021

    Ian Marsh
    Lisa Marzano
    David Mosse
    Jay-Marie Mackenzie

    To understand from first-person accounts the processes and planning involved in a suicide attempt on the railway.

    By giving people free reign to describe in their own words the processes they went through in planning and undertaking a suicide attempt, and by not interpreting such accounts through a lens of deficit and pathology, we can arrive at important insights into how people come to think and feel about, plan and enact a suicide attempt. The findings have implications in terms of understanding suicide risk and prevention more broadly

    B1 ‘… I just couldn’t sleep. It was impossible, every waking second I had these thoughts racing around my head and I just couldn’t stop it. I was on the internet, I was trying to figure out what was going on, couldn’t sleep and I suddenly thought about suicide. And my mind calmed down. That was the only way that I could describe it. Absolutely calmed down, and I went on the internet and started to research suicide methods basically.’ [survived a suicide attempt by another method, having considered but rejected a rail suicide]

    A5 ‘They knew that I was having issues because I was shouting and throwing stuff about in my room and I’ve never done anything like it before, I was just going by feelings and thoughts. So I didn’t say, I don’t remember saying, but they knew that I was heading towards the train station, so that’s why they called, because I think they assumed the worst.’ [survived a suicide attempt on the railways]

    A6 ‘I was very frightened because I was scared of the police from previous experiences, it was a horrible, horrible experience. And I got more and more frightened and I started to make my way to this bridge’ [survived a suicide attempt on the railways]

    The interview approach we used may also have played a part in the creation of a particular narrative. We did, however, strive to ensure as much as possible that participants were given the time and space to recount their stories in their own words and in their own way.

    First-person accounts may allow us to better understand how people decide upon a particular method, time and place for a suicide attempt. By giving people free rein to describe in their own words the processes they went through in planning and undertaking a suicide attempt, and by not interpreting such accounts through a lens of deficit and pathology, we can gain important insights into how people come to think about, experience, plan and enact a suicide attempt. These insights, we believe, have implications for how we understand the ‘suicidal process’ and people’s planning of suicide attempts.

    The interviews also affirmed the importance of paying attention to the personal meanings involved in suicidal behaviour, ……….
    Suicide, in the accounts from our participants, is described most often as a way out of profound psychological pain and distress. Ways to alleviate the suffering and pain experienced by people vulnerable to suicide should undoubtedly remain the focus of prevention efforts. However, if we interpret people’s accounts of their experiences (clinically and from a research perspective) only through a lens of individual deficit and impairment, our understanding of how people actually come to think about, plan and enact a suicide attempt may be unnecessarily limited.

    Data availability
    The Results section of this article provides illustrative examples of our data which have been anonymised. Owing to the qualitative nature of this study, we cannot make full transcripts, footage or survey data available as these could potentially identify our participantss.

    It might be worth contacting the lead researcher to suggest a futher publication as despite being obviously sensitive they have completely missed that the turmoil described by some people who contributed might have been caused by the drugs some had probably been prescibed . For example A5
    Dr Lisa Marzano
    Associate Professor in Psychology
    +44 (0)20 8411 6998

  10. Knock knock – who’se there – not anymore on the basis of a video call

    Mental Health Act: doctors should not use video assessments to detain patients during pandemic, say judges
    BMJ 2021; 372 doi: (Published 25 January 2021)

    Guidance from NHS England that doctors may lawfully use video assessments during the pandemic to decide whether patients should be detained in hospital under the Mental Health Act was wrong, two High Court judges have ruled.1

    The act makes it a legal requirement that doctors must “personally examine” a patient before recommending detention. A code of practice requires “direct personal examination of the patient and their mental state.” But guidance from NHS England just after the start of the first lockdown last March said that “temporary departures from the code of practice may be justified in the interests of minimising risk to patients, staff, and the public.” Revised guidance in May 2020 included a section drafted jointly by NHS England and the Department of Health and Social Care for England (DHSC) “for use in the pandemic only.” This stated, “It is the opinion of NHS England and NHS Improvement and the DHSC that developments in digital technology are now such that staff may be satisfied, on the basis of video assessments, that they have personally seen or examined a person ‘in a suitable manner.’ ”

    The guidance added, “While NHS England and NHS Improvement and the DHSC are satisfied that the provisions of the Mental Health Act do allow for video assessments to occur, providers should be aware that only courts can provide a definitive interpretation of the law.” It went on, “Even during the covid-19 pandemic it is always preferable to carry out a Mental Health Act assessment in person. Decisions should be made on a case-by-case basis and processes must ensure that a high quality assessment occurs.”

    The Devon Partnership NHS Trust asked the High Court for declarations that requirements in the act to have “personally examined” or “personally seen” the patient could be fulfilled by doing so remotely, if that was deemed sufficient in the judgment of the person applying the guidance.

    Fenella Morris QC, for the trust, told the court that the guidance was ambivalent and “expressly steps back from providing certainty on the matter to professionals and the public.” She said the trust had carried out only one video assessment and, with one exception, other trusts had taken a similarly cautious approach.

    Morris said doctors faced a choice of either carrying out a remote assessment and being found to have failed to comply with the act, “so that a patient is wrongly detained and the professional exposed to the risk of allegations of false imprisonment or, on the other hand, of carrying out an in person assessment and thereby jeopardising their health and that of their patients and the public.”

    The other party to the case, Matt Hancock, the health and social care secretary for England, agreed with the trust in seeking the declarations. That meant that nobody was arguing the opposing case, so an advocate to the court was appointed to make sure the two judges heard all the arguments.

    The judges, Dame Victoria Sharp, president of the Queen’s Bench Division, and Mr Justice Chamberlain, concluded that the phrases “personally seen” and “personally examined” required physical attendance on the patient, and refused the declarations. “We are acutely aware of the difficulties to which the statutory provisions—as we have construed them—give rise for the trust and for others exercising functions under the Mental Health Act,” they wrote in their judgment. “Nothing we have said should be taken as minimising those difficulties. Whether and how to tackle them will be for parliament to decide.”

    The DHSC said NHS England would be revising its guidance on video assessments following the judgment.

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