‘Tis the Season to Rebel

December, 23, 2019 | 24 Comments



    Pulse 2019 review: Hancock goes Back to the Future with AI
    23 December 2019

    The health secretary has been a big fan of Artificial Intelligence this year. Allie Anderson reports

    ‘Artificial intelligence blunts any residual patient intelligence’ says one GP commenter. It is only one of many offensive comments -over the years, they’ve been toned down but this sort of nonsense can still be published.Any one of us could end up consulting him/her without knowing- with implications on ‘treatment’. Robot or ass….s I would prefer the robot. So it is interesting to see why and when they decide to speak out against Matt H and his obsession with AI. Some of them seem to have seen where things are going – what will they do about it? Make more ‘jokes’. tell M H where to stick his AI – find another job..if more of us are harmed by Elexa there will be even less means of redress – we can’t prosecute a robot presumably. .

    PM pledges £250m for artificial intelligence in NHS
    08 Aug 2019

    Fans of the Back to the Future movie franchise behold, for we’re hoverboarding our way speedily towards a society where technology infiltrates every part of our lives – even healthcare.

    With the most tech-friendly health secretary in history leading the way, the Government is embracing the use of artificial intelligence (AI) to improve outcomes.

    Plans include a £250m investment to boost AI and genomic testing in the NHS, and a national AI lab to help cut waiting times and detect diseases earlier.

    Patients wanting advice about their symptoms will be able to ask Amazon’s virtual assistant, Alexa, and receive health information in response, when an agreed partnership between Amazon and NHS England gets up and running.

    It’s not hard to come up with reasons why this might not be the best idea. Top of the list is that the algorithms for tech-enabled healthcare aren’t fool-proof.

    What if a symptom checker gives a false negative? Patients could be wrongly assured they don’t need medical help, when they do. The potential consequences don’t bear thinking about.

    The opposite scenario, although not as dangerous, isn’t ideal either – and is likely to be much more common.

    If a symptom checker generates a false positive, then worried patients will inevitably end up placing unnecessary burdens on NHS resources.

    That was borne out when Pulse decided to test four symptom checker apps with four hypothetical medical scenarios, each one presented by a theoretical anxious and non-anxious patient. Most of the apps in all eight scenarios bar one advised seeing a GP urgently, going to A&E, or calling 999.

    Perhaps predictably, many of the suggestions would end making the patient more anxious, and ultimately being detrimental to their well-being in the long term.

    And we all know where anxious patients end up one way or another: knocking on their GP’s door.

    But maybe AI will take us several leaps further. If Hancock and co have their way, it certainly will. Who knows, before long we’ll have patients using technology to perform surgery on themselves.

    And where will that leave GPs?

    Where we’re going, we don’t need GPs!

  2. Clocked …

    “The Board of Directors decided that a change in leadership was necessary to restore confidence in the Company moving forward as it works to repair relationships with regulators, customers, and all other stakeholders,” the company said.


    The Starliner returned to Earth, landing in the Army’s White Sands Missile Range, after it was launched by the Atlas V rocket Friday morning. The flight was aborted because the capsule’s clock was not synced up properly with the timing on the rocket — and it ultimately ended up in the wrong orbit.


    “We started the clock at the wrong time,” Jim Chilton, a senior vice president for Boeing, said Saturday. “As a result of starting the clock at the wrong time, the spacecraft upon reaching space thought she was later in the mission and, being autonomous, started to behave that way.”

    …..where he started as an intern in 1985, rising through the company’s defense and services ranks to the top job in 2015.

    Far be it from me to compare comparisons…why hold the holding-pattern – back


    Containing ‘Star-Cameos’

    Richard Brook was actually threatened with legal action –


    ‘the time of your life’

    as this ship docks …

  3. Thank you and Merry Christmas. I used your work on prescriber abuse and some from Pharmageddon to argue my case in court last week. I now am more fully aware of dependence on Risperdone and recovery from this dependence not much different to heroine or alcohol – opening to the world and others with innocence and developing clarity and equanimity. When there is abuse and conflict and violence – it turns it all into a horror story and night mare. I now understand how common institutional abuse is and how it links to families and communities with reputations to protect. I also know how risky putting in a complaint can be and holding to certain views. It can be a personal safety issue.And this links in with higher education which is training the health care work force. I have a prescriber who has a bit of a vendetta against me saying things like I have strong views against biological psychiatry and that my social justice views are abnormal. Prescriber abuse goes into the realms of murder and manslaughter and that is heavy. Judgment comes through on Monday. I hope I get the decision I am after and can be left alone by my prescribe and her associates and can have some peace to move on in my life after losing so much and having so much taken from me. All the best.

  4. There has never been a time in which our rulers cared whether or not common people were “fulfilled” or “self-actualized” – I’m not even sure they should. But they sure as Hell wanted people to be productive. They don’t want that anymore.

    Modern technology has eliminated much of the need for repetitive manual labor, freeing up an enormous amount of human potential. We could be talking about ways to be putting all this untapped human potential towards creating institutions and paradigms that do a better job of meeting actual human needs, but we are not having that conversation. We live in a society in which people are exploited as consumers – of nutritionally barren junk food, of manufactured entertainment, of useless and dangerous medical interventions – as ruthlessly as they once were for their labor.

    • Oh Patrick, when the doctors, entire mental associates, and, indeed, governments and their lackey regulators, have been groomed/duped, in to trusting, I think, your little insight in to philosophical reasoning is a nice refreshment as to how low down in the ticking/pecking order, small matters like life and death from antidepressants fall – too many, as usual, who could do more, do less, and, you might say that it suits, an overall majority, to act as this – to me, it has all happened by accident, a happen chance of fate. Who knew the ‘guilty secrets’, would stir, would make waves, would predispose the relatively ordinary mortal to take up sticks and wave the bloody banner,

      Who knew, who knows – what do you really think about mass extinction of sudden death from a mere pill (s); have you any idea how to take out the philosophical drift, to the treason that is cast?

      In simple words, a world-wide scam, has hoodwinked, those, who, on the face of it, are/were ‘placed’ – how must it feel for those, honoured, on a giant hamster wheel, to go faster, go up the ladder, go, go, go, and, for what, a shallow pit, of primal aggrandisement.

      If this all remains the same, then, life as we know it, has gone, gone, gone and those worshipped and respected, have sunk so low, that the normal everyday way of living is well and truly sunk?

  5. To find the answers we need, and win the so-called battle of good and evil, may I respectfully recommend the unassuming but enlightening insights of another magnificent Irishman, from Dublin no less, another McMahon, a Mr Paddy McMahon and his amazing book, ‘Guided by Angels’. This is well worth a read. It shows us how, not by religion but by a power of good, available to all, we can achieve absolutely anything. And how. Miracles do happen.

  6. And there’s also the ‘principles’ =s we know principled people run everything in a democracy – The college of psychiatry in Ireland even includes the code of Human Rights in their ‘principles’ for practicing psychiatry. And we all know how that fails to protect millions of people all over the globe. Summary of Principles produced by some highly principled people chosen by each other.
    Principle 1 Psychiatrists shall treat every patient with respect.
    Principle 2 Psychiatrists shall not exploit patients.
    Principle 3 Psychiatrists should continue to develop, maintain, and share their
    professional knowledge and skills.
    Principle 4 Psychiatrists should provide the best possible psychiatric care for their
    Principle 5 Psychiatrists shall respect the right to confidentiality of patients and
    their families.
    Principle 6 Psychiatrists shall seek consent with due regard to capacity.
    Principle 7 Psychiatrists should ensure patients and their carers are provided with
    adequate and sufficient information to make informed choices with
    respect to available treatment.
    Principle 8 Psychiatrists shall not misuse their professional knowledge and skills.
    Principle 9 Psychiatrists should comply with ethical principles embodied in both
    national and agreed international guidelines governing research.
    Principle 10 Psychiatrists should promote and support the wellbeing and mental
    health of their colleagues, including trainees and students.
    Principle 11 Psychiatrists shall maintain the compassion, honesty, moral
    principles, and probity of the medical profession.
    Principle 12 Psychiatrists should work to improve mental health services and
    promote community awareness of mental illness and its treatment
    and prevention, and reduce the effects of stigma and discrimination.

    It’s worth reading the whole document even to see how many principles are breached every hour of every day and as we are thinking of Stephen O’Brien lately – how principled was his and his family’s treatment.

  7. Favourite tv programmes over the Christmas period in UK include the fascinating and brilliantly acted series ‘Call the Midwife’ which shows us how the health service worked in the 1950s and 1960s. Some tv channels run back to back earlier episodes for us to enjoy again. I for one never get tired of seeing them. There was one in Christmas week about Distaval, or thalidomide as we know it better, and it was interesting and very heartening to see the reaction of the GP Dr Taylor, who had been prescribing it in good faith, till he was alerted to suspicions about it. There was no covert hushing up of blame. He, (wrongly) blamed himself, and his team of midwives rushed around the district gathering up bottles of pills from every patient they could trace, who had had it. Some of these had shared them with friends and relatives, which made the confiscations even more difficult to pinpoint. Also we saw how much care and extra help was given to those families whose babies had been born with disfigured bodies, due to the drug. And how Dr Taylor moved heaven and earth to help where he could. Distaval had been given as a sedative to pregnant mums. There were presumably other sedatives on the market. Its removal was quick once the association with damage to the unborn was suspected.

    Fast forward to today. We have drugs with similar effects like Accutane/isotretinoin on the market. We know they damage the unborn. This fact is accepted by Roche. Parents of young people who take it for acne, prescribed for them by dermatologists (but following the NICE codes like lemmings) know the damage it is causing, as they watch it change their kids from outgoing normally functioning offspring, into zombies. Where are the Dr Taylor’s now? The kids are suspected of having been depressed before they ever touched the drug, so the drug cannot be blamed for the rising number of suicides – more this year than ever before. (See Sarah Marsh’s article in the Guardian 26th December). Show me anyone who isn’t a bit fed up and miserable about having acne. Is that depression? How does the code work for that? Where does the line begin and end?

    Oh for an army of Dr Taylors now, who put the wellbeing of the patients first, whose integrity was their only code. Thank heaven we can at least remember how things were by seeing it set out for us in ‘Call the Midwife’. Heidi Thomas, who wrote the series and is married to the actor who plays Dr Taylor, was on Desert Island Discs on Radio 4 several weeks ago. She was a delight to listen to. Her luxury item for the desert island was a hot water bottle. It would be mine too.

  8. Home
    Friday, 27 March 2015 13:24 The ‘ninja’ NHS privatisers you’ve never heard of…
    By Tamasin Cave
    Print Email
    The 'ninja' NHS privatisers you've never heard of…
    Meet the shadowy team at the heart of many of the most controversial NHS privatisations to date, including the Staffordshire deal leaked last week to openDemocracy.

  9. The Whistleblower and Penn: A Final Accounting of Study 352

    The letter couldn’t have been more blunt. The second draft of the manuscript was finished, and Nemeroff and Evans were “invited to participate” as authors of the article. Or to put it another way, they were being invited to commit research fraud.

    Nemeroff would become first author on the paper. And when Amsterdam read these letters, he realized that the only investigator in the trials who saw most of the drafts, and was at least slightly involved in analyzing the results, was Gyulai. In 2001, Amsterdam had thought that Gyulai might have been the principal culprit in claiming authorship for work that he had not done, but it was now clear that Nemeroff and Evans were much worse offenders.


    by Peter Simons

    December 29, 2019

    Although the general story of ghostwriting in trials of psychiatric drugs is now pretty well known, the details of the corruption in specific trials are still emerging into the public record, often a decade or more after the original sin of fraudulent publication. The latest study to finally see the full light of day is GlaxoSmithKline’s study 352.

    Perhaps the most infamous ghostwritten study is GSK’s study 329, which, in a 2001 report published in the American Journal of Psychiatry, falsely touted paroxetine (Paxil) as an effective treatment for adolescent depression. The company paid over $3 billion in penalties for fraud.

    After its publication in 2001, the article was cited in hundeds of medical journals, textbooks and practice guidelines as evidence that Paxil could be beneficial in the treatment of bipolar depression. It may still be cited for that “finding,” and in that way, the corruption lives on.

    • This article Annie references is a beautifully written piece – well worth reading, as is the original Amsterdam and McHenry article


      • Over 6 years ago I made this film about Charles Nemeroff:

        Peter J. Gordon December 31, 2019 at 3:48 am

        Dear Peter,
        Thank you for writing such a clear exposition and vitally important account of scientific fraud. The scale of harm resulting from this fraud like this is now being revealed as lives, like mine, are ruined by drugs like Paroxetine.


        Professor Carmine Pariante invited Professor Charles Nemeroff to give inaugural lecture at Maudsley Research Unit.

        Prof Nemeroff was exposed for concealing large payments from drug companies.

        sails blithely …

        • Amsterdam Files New Study 352 Whistleblower Complaint


          Jay Amsterdam, who first blew the whistle on corrupt research practices in a study conducted by GlaxoSmithKline (GSK) eight years ago, has now submitted another whistleblower complaint to the federal Office of Research Integrity (ORI) based on new evidence that has come to light.

          “Because the research performed in the paroxetine 352 study was conducted on behalf of the U.S. taxpayer via NIMH funding, we respectfully request that the misconduct case be re-opened in order to correct the scientific record about errors of fact and judgment in Penn’s prior adjudication of this case,” Amsterdam wrote.

          Mad in America recently published an in-depth report about Amsterdam and the corrupt practices of Study 352.

          This will be Amsterdam’s third attempt to convince ORI that research misconduct occurred. The previous two letters, sent in 2011 and 2012, provided the information that Amsterdam knew at that time: that the study was ghostwritten, and the supposed authors (two of whom were in his department at the University of Pennsylvania) had signed their names to an article they hadn’t written.

          : ORI 2012-33 – Complaint of Scientific Misconduct against

          Dwight L. Evans, Laszlo Gyulai, Charles B. Nemeroff, Gary S. Sachs, and Charles L. Bowden


          Amsterdam noted in his complaint that the study 352 paper has been cited over 500 times in favor of paroxetine, despite the actual results being almost universally negative. The paper also has been cited in influential treatment guidelines. Because this could be harmful for patients, Amsterdam urged the ORI to reopen its case and examine the newly-released documents.

  10. https://powerbase.info/images/9/93/CorporateCaptureRoundtable_Spinwatch-page-001.jpg

    This is a diagram showing how the wheel keeps turning – the same people taking chairs/leads of NHS orgs moving back and fore around private orgs and back again into NHS – or vice versa The information hasn’t been updated but the situation is the same currently

    If the image doesn’t come up see on Powerbase Pharma
    By the way the new ‘Father’ (how quaint) of the house of commons , Peter Bottomley showed without even realising how the political situation is full of cronyism and nepotism by describing how his wife Virginia was given positions by dint of who she knew, including at one time becoming the English health minister. Many of these end up in the house of lords where they carry on lobbying and influencing policies they have self interests in.

  11. There is no drug in the world that has the ‘checkered’ history of Paroxetine.

    The wretched-drug, and the wretched-people, involved with the drug.

    This is where it all started with Paroxetine, when the UK took up the mantle to sue GlaxoSmithKline.

    DRUGS giant GlaxoSmithKline is facing the possibility of a multi-million pound UK-based lawsuit in connection with its controversial anti-depressant drug Seroxat.

    Lawyers acting for the UK Seroxat Users’ Group said yesterday they are just “weeks away” from launching a class action claiming the drug is defective under consumer law.

    They are expected to claim unspecified damages for the group’s 3,500 members and demand information from GSK as to how users can stop taking the drug.

    Last night Mark Harvey, a partner in law firm Hugh James, confirmed he would be writing to GSK over the coming weeks to formally notify it of the action.

    “We think it is a strong case”, he told The Scotsman. “All the evidence we have seen suggests the drug is defective.


    21 June, 2004

    “We want people who are having difficulties withdrawing to be told how to do it safely, warnings that there is an increased risk of suicide and compensation for those affected.”

    Earlier this month a US-based civil action was filed against GSK by Eliot Spitzer, the New York State Attorney General, claiming the company engaged in “repeated and persistent fraud” by failing to disclose information about Seroxat’s safety and effectiveness.

    Harvey said his law firm was representing people who had suffered “significant withdrawal reactions”; those who were unable to quit using the drug and the families of users who have committed suicide.

    A spokesman for GSK responded: “We will assess it [the claim] when we receive something from them.”

    This all fell to dust, and the litigation was subsequently taken over, twice, and is currently running …

    This an interesting ‘tail’, in itself ..

    Let there be no mistake about the dangerousness of Paroxetine and let there be no mistake about all the ghosts within it’s sordid trail.

    The Paroxetine 352 Bipolar Study Revisited: Deconstruction of Corporate and Academic Misconduct


    ‘Thus, GSK was able to take an under-powered and non-informative trial with negative results and present it as a positive marketing vehicle for off-label promotion of paroxetine for bipolar depression. In addition to the commercial spin of paroxetine efficacy, important protocol-designated safety data were unreported that may have shown paroxetine to produce potentially harmful adverse events.’

    in front of a populace, and, yet, those who could, are unyielding …

    Some things never die …

  12. Having, possibly, found more time for in-depth reading recently, I have found MIA to have covered three areas of grave concern. One is the article quoted by Annie which seems to reiterate so much of what we’ve read before – disgusting to read of so many humans who seem to be rotten to the core. Not only the ones who carry out the ‘frauds’ (for that is what they are in my book) but also the other set who fail to stand up and correct all that’s so wrong in the world of research. It worries me when thinking about researchers and statisticians who wish to tread the correct path – could they too be drawn, unknowingly, into this web? Or, if they refuse, does their honest work count for nothing?
    There was also a blog about Zel Dolinsky – extremely tragic but so understandable. He was another who had worked for Pharma but woke up to exactly what he had been peddling on their behalf when he personally fell into the trap of drug dependency and withdrawal. He suffered akathisia which became more than he could bare. The title of that article is ‘I have a Right to Death with Dignity’ – the end of this article is particularly touching.
    Thirdly we had another blog entitled ‘The Invisibles: Children in Foster Care’, possibly of more interest to some of us than to others. Here, again, we have the ‘Authorities’ deciding that the needs of vulnerable children are along the lines of ‘supporting Pharma’ rather than providing love and care by patient adults to heal their emotional needs.
    I could not describe any of the above as ‘comfort reading’ for sure but well worth reading nevertheless. I then came across the article which says it all – ‘Trump Calls for “Keeping very dangerous people off our streets” at Mental Health Summit’. So there we are, back to blaming the individuals for their ills which are so often caused by the misdemeanours of those who should behave better. That attitude of ‘out of sight out of mind’ could soon take solid roots here in the UK too I fear unless we keep speaking up and do our utmost to protect the vulnerable.
    Bring on 2020 – let’s hope for more than 2019 provided for many of us.

  13. Rapid Response: (by Stavros Saripanidas Dec 30th 2019))
    No biological markers correlated to depression
    Dear Editor,

    A systematic review and meta-analysis of 51 randomized controlled trials of psychotherapy for adult depression concluded that numerous objective biological markers were not influenced/changed after successful treatments.

    An extensive systematic review and meta-analysis of 75 published prospective clinical trials on 39,028,432 participants, followed-up for a median of 3 years, revealed that none of the examined hormonal, biochemical, immunological, neurological, oxidative, or anatomical biomarkers was correlated to onset and relapse/recurrence of major depressive disorder.
    The Authors concluded that there is lack of evidence for leading biological theories for onset and maintenance of depression.

    A large systematic review of 29 published relevant scientific studies has clearly demonstrated that there exists no documented biological subtype of clinical depression.

    Competing interests: No competing interests

    Brain imaging of not only adults by youngsters and very young babies is being carried out at UCL UK and in USA. (Some of it in the sci fi named ‘baby labs’). This is an area where massive amounts of money are being awarded from both government and private donors in UK. The group talking an interest in this at UCL include psychoanalysts and those promoting ‘attachment theory’. Psychoanalysis was in danger of becoming extinct from the NHS but they have made a clever strategy for survival by moving into social control, pushing social projects for parents and promoting ‘relational therapy’ for parents/carers diagnosed as inadequately parenting children. The therapy is attempting to alter the brain structure. It is being promoted including by psychiatrists-therapists who have practiced using drugs not just therapy. How soon before they will be unable to resist trying/succeeding in altering the brains of those they decide are potentially ‘at risk’ of becoming whatever they diagnose from these brain images.. UCL has a notorious past history regarding experimenting on vulnerable groups and promoting eugenics. The funding for the work including at the new grossly expensive Anna Freud Centre is provided both by the governmnt and private donation from a billionaire Russian oligarch, Moshe Kantor. He and his family fund projects which conform to their own family values (publicly stated). Why is this allowed? There is a relationship with Peter Fonagay who heads this work at UCL but is that all? (Strangely there is a photo with Kantor standing in a group with Putin. Maybe this is because he made some of his money in agri chemicals in Russia)

  14. The Annual Death Count of the Children –

    Ellie, Shakira, Rachel, Aeryn, Jasmine, Tyla, Jesse, Oliver, Suzie, Aryan, Marcelo, Quinn, Taylor, Grace, Mia, Jacob, Nicole & Ash.
    Just some of the children of England & Wales whose inquests were held last year. http://antidepaware.co.uk/the-lost-children-2019/…

    The Lost Children (2019)
    Posted on January 1, 2020 by Brian — No Comments ↓


    Michael P. Hengartner, PhD

    A few days ago I received a hostile letter from the heads of Swiss psychiatry. They wrote my public statements about AD dependence and withdrawal are absurd and misleading. They state that it‘s as absurd as if I would claim that people with diabetes are addicted to insulin.

    But they won‘t silence me, because we have the scientific evidence that suggests that just like the benzodiazepines, AD too can cause dependence and withdrawal. And user reports confirm these findings. IMO denying this evidence base is absurd and misleading.

    ‘However, until the RCPsych can come up with an efficient strategy to prevent children’s dying by “suicide”, those whose lives are taken from them by SSRI-induced akathisia will continue to be regarded merely as collateral damage.’

    Right …

  15. https://publications.parliament.uk/pa/cm201719/cmselect/cmcumeds/363/36311.htm#_idTextAnchor066
    https://publications.parliament.uk/pa/cm201719/cmselect/cmcumeds/1630/ Contact us Culture, Media and Sport
    Disinformation and ‘fake news’: Interim Report Contents
    1.The term ‘fake news’ is bandied around with no clear idea of what it means, or agreed definition. The term has taken on a variety of meanings, including a description of any statement that is not liked or agreed with by the reader. We recommend that the Government rejects the term ‘fake news’, and instead puts forward an agreed definition of the words ‘misinformation’ and ‘disinformation’. With such a shared definition, and clear guidelines for companies, organisations, and the Government to follow, there will be a shared consistency of meaning across the platforms, which can be used as the basis of regulation and enforcement. (Paragraph 14)

    2.We recommend that the Government uses the rules given to Ofcom under the Communications Act 2003 to set and enforce content standards for television and radio broadcasters, including rules relating to accuracy and impartiality, as a basis for setting standards for online content. We look forward to hearing Ofcom’s plans for greater regulation of social media this autumn. We plan to comment on these in our further Report. (Paragraph 15)

    3.The Government should support research into the methods by which misinformation and disinformation are created and spread across the internet: a core part of this is fact-checking. We recommend that the Government initiate a working group of experts to create a credible annotation of standards, so that people can see, at a glance, the level of verification of a site. This would help people to decide on the level of importance that they put on those sites. (Paragraph 18)

    Hardly engenders trust – who decides who get appointed as an ‘expert’ Things have moved on, the group has already been set up as stated by a woman on r4 who is on the group.butcan’t find any info about them online. Maybe they’ve taken themselves down for spreading fake news about those who won’t be silenced like wonderful Michael Hengartner. It would be interesting to read the actual letter the Swiss sent M H Wonder why Swiss? Is the message about ADsgetting out too successfully in Switzerland.? Holding my breath for a letter signed by all members of psychiatry establishments world wide. Bet they’re all networking like crazy.

    • Samizdat

      Health Writer’s Co-operative

      The Decapitation of Care


      El retorno del empirismo http://nogracias.org/2020/01/05/el-retorno-del-empirismo-por-abel-novoa/…
      Por @AbelNovoa Con @DrDavidHealy @DeeMangin

      El retorno del empirismo. Por Abel Novoa

      por nmurcia | Ene 5, 2020


      Extracts, Google, translate..

      The return of empiricism.

      By Abel Novoa

      The Irishman David Healy has the best critical head of contemporary medicine. Amalgam knowledge about MBE, history of medicine, philosophy and epistemology, health policy and regulatory processes, with clinical experience and an activist, pragmatic and committed vocation.

      I have had the honor and intellectual pleasure of translating a short essay entitled “The Decapitation of Care” – which will be published very soon jointly in English, French and Spanish – where it addresses, extensively, among many other things, the proposal expressed in This BMJ article, “Clinical judgments, not algorithms, are key to patient safety — an essay by David Healy and Dee Mangin”, recently published and which we are going to comment on

      The clinical trial and evidence-based medicine were born to avoid empirical bias. Empiricism is a doctrine “that emphasizes the role of experience (linked to sensory perception) in learning and knowledge induction.” Empiricism or particular experience, along with rationalism (in the form of speculative thinking, as was the theory of moods), were the basis of medicine from the Hippocratic doctors.

      This type of thinking and way of generating knowledge was what allowed the survival during 2000 years of a therapy such as bleeding or phlebotomy. Alexander Louis, of the School of Paris, is the first researcher who statistically studied the results of bleeding by not confusing the empirical-analytical method, demonstrating its uselessness.

      They begin their article – David Healy (of the Department of Psychiatry of the Bangor University of Wales) and Dee Mangin (a professor of the Department of Family Medicine of the McMaster University in Ontario) – recalling as a side effect as well described as the “Sexual Dysfunction Permanent after SSRIs ”continues to be denied in the fluoxetine data sheet with the usual crutch:“ there are no adequate and well-controlled studies examining sexual dysfunction in relation to the treatment of fluoxetine ”.

      That is, for Healy and Mangin, medicine has gone from fetishizing the empirical experience (which led to the maintenance of bleeding for almost 2000 years) to fetishizing the clinical trial:

      “Fetish ECAs as the only valid tool in medicine to establish causal relationships on the effects of medications is a problem.”

  16. Isotretinoin: experts convene to investigate new concerns over suicide risk
    BMJ 2019; 367 doi: https://doi.org/10.1136/bmj.l7085 (Published 31 Decembe
    An expert group has been reconvened to review recent safety data relating to the acne drug isotretinoin (marketed as Roaccutane) and evaluate the risk of sexual and psychiatric adverse effects, including suicide.

    The Medicines and Healthcare Products Regulatory Agency’s isotretinoin expert working group had looked at the risk of psychiatric adverse reactions suspected to be associated with isotretinoin in 2014, but it has now reformed to look at more recently reported adverse reactions. In 2019 12 deaths were recorded among people to whom isotretinoin had been prescribed, 10 by suicide, MHRA data …

    access to ful article is behind a paywall As so often the information we all need is not made accessible in so called ‘open access’ journals even though they couldn’t exist without using individuals’ information.

    • Text here
      An expert group has been reconvened to review recent safety data relating to the acne drug isotretinoin (marketed as Roaccutane) and evaluate the risk of sexual and psychiatric adverse effects, including suicide.

      The Medicines and Healthcare Products Regulatory Agency’s isotretinoin expert working group had looked at the risk of psychiatric adverse reactions suspected to be associated with isotretinoin in 2014, but it has now reformed to look at more recently reported adverse reactions. In 2019 12 deaths were recorded among people to whom isotretinoin had been prescribed, 10 by suicide, MHRA data show.

      The working group will include experts in clinical pharmacology, psychopharmacology, psychiatry, and general practice. It will hold its first meeting as early as possible in 2020.

      As part of its review the group will consider whether regulatory action is needed to minimise risks or raise awareness of the risks, after reports of sexual and psychiatric adverse reactions linked to isotretinoin.

      The group’s findings and recommendations will be passed to the Commission on Human Medicines, another MHRA body, which will advise the MHRA and relevant ministers on whether regulatory action is needed. Action could take the form of restrictions on when to use the drug, updates to the product information, additional risk minimisation materials, further study of the issue, or a communication strategy.

      A Swedish cohort study published in The BMJ in 2010 found an increased risk of attempted suicide up to six months after the end of treatment with isotretinoin but that the risk was already rising before treatment, so an additional risk due to the isotretinoin treatment could not be established.1

      The working group’s 2014 review concluded that “acne, whether or not it is treated with isotretinoin, is associated with psychiatric disorders.” However, it said that the available data were “insufficient to establish a causal association but could not rule out an association between isotretinoin and psychiatric disorders.”2

      It recommended that patients be routinely screened and monitored for psychiatric disorders, and that education on and awareness of risks should be considered for patients and their family and friends.

      The report also called for a “carefully designed prospective study” to look at the possible association between isotretinoin and psychiatric disorders, although it added that “standard epidemiological studies were unlikely to provide sufficient data to establish a causal association.”

      A spokesperson for Roche, which markets Roaccutane, said, “We take the safety of all our medicines very seriously. Millions of patients worldwide have taken Roaccutane, but like most medications it can have side effects. That is why we recommend it is prescribed carefully, with particular consideration regarding any previous history of depression, that patients understand what to expect when they take it, and that they are monitored closely to ensure they get the care they need.”

      ↵Sundström A, Alfredsson L, Sjölin-Forsberg G, Gerdén B, Bergman U, Jokinen J. Association of suicide attempts with acne and treatment with isotretinoin: retrospective Swedish cohort study. BMJ2010;341:c5812. doi:10.1136/bmj.c5812 pmid:21071484Abstract/FREE Full TextGoogle Scholar
      ↵Medicines and Healthcare Products Regulatory Agency. Review of isotretinoin and psychiatric adverse reactions. 2014. https://assets.publishing.service.gov.uk/media/5492db7ce5274a42900002f2/DSU2.pdf.Google Scholar

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