They Used to Call It Medicine

October, 1, 2021 | 9 Comments

Comments

  1. I think this is a most powerful and moving post and hope at least some of the attendees will take up the call to arms
    This is an example of why I would never disclose adverse events to Bayer Pharmaceutical or any other and why I hope Rxisk will be setting up something independantly which can be used world wide for the individuals’ benefit as well for the general good rather than the benefit of Bayer

    Privacy Statement for Pharmacovigilance Data
    Bayer takes product safety and your privacy seriously

    Our Pharmacovigilance obligations require us to process certain information, which allow to directly or indirectly identify a person, (“Personal Data”) of a patient and/or the reporter of an adverse event that we receive in order to comply with strict obligations to perform benefit-/risk assessments of Bayer Health Products continuously and report suspected adverse reactions or events to relevant regulatory authorities.

    This Pharmacovigilance Privacy Statement (“Statement”) provides important information to you about how we process Personal Data for PV purposes, in line with our obligations under applicable data privacy laws and in particular the EU General Data Protection Regulation ((EU) 2016/679) (“GDPR”).

    If you are a resident of California or Nevada in the United States, you may have additional rights regarding your personal data. found here.(These are described disengenuously as ‘exceptions’ to other states but allow Bayer to process much more personal info)

  2. He is considered by some to be one of the most important intellectuals of the 20th century.

    Havel first rose to prominence as a playwright in works such as The Garden Party

    What about the pharmacy data that’s already being used by PHARMA to track physician’s prescribing patterns? And where are the departments of pharmacology and the schools of pharmacy in following medication efficacy and safety? or the HMOs? or the Health Plans? the VAH? What about the waiting room questionnaires? I’d much rather they ask about the medications the patient is on than being used to screen for depression. It’s really the ongoing data after a drug is in use that clinicians need anyway – more important than the RTC that gets things started.

    So while it’s important to continue the push for data transparency and clinical trial reporting reform, it’s also time to explore other ways of gathering and evaluating the mass of information that might free us from the commercial strangle-hold we live with now – and potentially give us an even better picture of what our medications are doing over time.

    There’s a way out of this conundrum. The task is to find it…

    the commercial strangle-hold…

    Posted on Sunday 22 January 2017

    http://1boringoldman.com/index.php/2017/01/22/the-commercial-strangle-hold/

    And if we find it…

    https://www.youtube.com/watch?v=wQTpmhmQCS4

    Michael P. Hengartner, PhD
    @HengartnerMP

    In sum, the ANTLER trial raises more questions than it answers. Although there were more relapses in the discontinuation group than in the maintenance group, the effect of withdrawal symptoms was not taken into account. Unblinding was also frequent and was not taken into account.

    Melissa Raven
    @psychepi

    re Lewis et al. 2021 ‘Maintenance or Discontinuation of Antidepressants’ Thread by
    @markhoro
    on Thread Reader App

    https://threadreaderapp.com/thread/1443505742842109953.html

    Startling lack of interest in confounding by withdrawal symptoms in this antidepressant discontinuation study in NEJM: bit.ly/3AYzP2Z Withdrawal symptoms in this discontinued group render this study uninterpretable. (1/n)

    The Garden Party…

    “the other good news is that if you do want to come off antidepressants for whatever reason, this can also be done safely over a couple of months.” – Professor Sir Simon Wessely –

    No Time to Die…

    • “I’m gobsmacked,” says @markhoro, who is also, interestingly, at @UCLPsychiatry . “This study is so against the grain. It seems to ignore all the work of the last couple of years, and the explosion of awareness of the trouble people have in #comingoff #antidepressants.”

      Miranda Levy
      @mirandalevycopy 3h

      Last week, we saw an astonishing study about how “long-term antidepressant use is beneficial.” Here is my riposte in @Telegraph, with the fabulous help of @markhoro and @Peter Gordon.

      I’m afraid it’s behind a paywall, but you can register for a free trial.

      https://telegraph.co.uk/health-fitness/mind/antidepressants-life-should-taking-first-place/

      Miranda Levy
      @mirandalevycopy
      ·
      3h

      @DrDavidHealy @stimimi

      If antidepressants are for life, should you be taking them in the first place?

      A new study goes against the scientific grain by suggesting that long-term use of pills can be beneficial, writes Miranda Levy

      ByMiranda Levy3 October 2021 • 12:00pm

      https://www.telegraph.co.uk/health-fitness/mind/antidepressants-life-should-taking-first-place/

      Great article by Miranda Levy, should be read by all – I registered for my free ‘trial’ –

      Expert reaction to study on long term use of antidepressants, discontinuation and relapse

      https://www.sciencemediacentre.org/expert-reaction-to-study-on-long-term-use-of-antidepressants-discontinuation-and-relapse/

      ‘chumocracy’ in action – Aye, Peter – the bright young bucks leave them standing…

      • Featuring the first major in-depth broadcast interview with Sir Patrick Vallance

        Government Chief Scientific Adviser, and the 10th anniversary of The Life Scientific

        Tuesday 12 October, throughout the day on BBC Radio 4

        As Chief Scientific Advisor to the government during the pandemic, Sir Patrick became a household name. His calm, clear summaries of the state of our scientific understanding of the virus were welcomed by many across the country, and the value of science, and scientific advice, were thrust centre stage. Now, as head of the new Office for Science and Technology Strategy, Sir Patrick plans to put science and technology at the heart of policy making in government.

        https://www.bbc.co.uk/programmes/m0010gkl

        The Life Scientific

        3 Nov 2015

        Patrick Vallance on pharmaceuticals

        While GSK is no stranger to scandal, since he joined, Patrick has attempted to tackle the culture of secrecy

        https://www.bbc.co.uk/programmes/b06mdbnq

        17.46You and your CEO Andrew Witty took another radical decision joining Alltrials

        20.42 When researchers got access to the trial data regarding the controversial antidepressant drug Seroxat

        “It’s inevitable that side effect things will occur from time to time and frankly I’d rather know them than not know them” …

        “I’d rather know, I’d rather get it out there” …

        https://study329.org/correspondence-with-gsk/

        2013-06-14 — The RIAT team sends an email to GSK, Sir Andrew Witty (CEO) and Patrick Vallance (President  of Pharmaceutical R&D), notifying them of the RIAT article publication and requesting that if they plan to restore any old GSK trials, they respond as soon as possible.

        From: Peter Doshi

        Date: 14 June 2013 at 19:26

        Subject: Restoring Invisible and Abandoned Trials – your response requested (GlaxoSmithKline)

        Dear Christopher Gent, Andrew Witty, and Patrick Vallance

        ‘side-effect ‘things’ …

  3. addition to info collected by Bayer (above)Effective Date: July 1, 2021

    This Privacy Statement Addendum provides additional information for residents of California or Nevada in the United States regarding what personal data we collect about you, what we do with it, and how you can control it in connection with our websites, mobile apps, or other online services (the “Site”).

    CALIFORNIA PRIVACY RIGHTS
    Categories of personal data we collect
    We collect information that identifies, relates to, describes, references, is reasonably capable of being associated with, or could reasonably be linked, directly or indirectly, with a particular California consumer or household (“personal data”). In particular, we have collected one or more data types in the following categories of personal data from consumers within the twelve (12) months preceding the effective date of this Privacy Statement:

    Category
    One or More Data
    Types Collected?

    A.
    Identifiers such as a real name, alias, postal address, unique personal identifier, online identifier, Internet Protocol address, email address, account name, social security number, driver’s license number, passport number, or other similar identifiers.
    Yes
    B.
    Any categories of personal data described in Cal. Civ. Code § 1798.80(e), such as name, signature, social security number, physical characteristics or description, address, telephone number, passport number, driver’s license or state identification card number, insurance policy number, education, employment, employment history, bank account number, credit card number, debit card number, or any other financial information, medical information, or health insurance information.
    Yes
    C.
    Characteristics of protected classifications under California or federal law.
    Yes
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    No

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    Biometric information, for example imagery of the iris, retina, fingerprint, face, hand, palm, vein patterns, and voice recordings, from which an identifier template, such as a faceprint, a minutiae template, or a voiceprint, can be extracted, and keystroke patterns or rhythms, gait patterns or rhythms, and sleep, health, or exercise data that contain identifying information.
    No
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    Internet or other electronic network activity information, including, but not limited to, browsing history, search history, and information regarding a consumer’s interaction with an Internet Web site, application, or advertisement.
    Yes
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    Yes
    I.

    Professional or employment-related information.
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    J.

    Non-public education information.
    No

    K.
    Inferences drawn from any of the information identified in this subdivision to create a profile about a consumer reflecting the consumer’s preferences, characteristics, psychological trends, predispositions, behavior, attitudes, intelligence, abilities, and aptitudes.
    Yes

    In particular, we collect the following types of information
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    Our business and commercial purposes for collecting personal data
    We use the personal data we collect for our operational purposes or other purposes set out in this Privacy Statement. Those purposes may include:

    Auditing related to a current interaction with the consumer and concurrent transactions, including, but not limited to, counting ad impressions to unique visitors, verifying positioning and quality of ad impressions, and auditing compliance with this specification and other standards.

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    Debugging to identify and repair errors that impair existing intended functionality.
    Short-term, transient use, provided the personal data is not disclosed to another third party and is not used to build a profile about a consumer or otherwise alter an individual consumer’s experience outside the current interaction, including, but not limited to, the contextual customization of ads shown as part of the same interaction.

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    Undertaking internal research for technological development and demonstration.

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    In the twelve (12) months preceding the effective date of this Privacy Statement, we have disclosed one or more data types in the following categories of personal data of California consumers for a business purpose:

    Category A: Identifiers.
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    Category D: Commercial information.
    Category E: Health or biometric information.
    Category F: Internet or other electronic network activity information.
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    Category K: Inferences drawn from other personal data.

    We also use the personal data we collect for our commercial or economic purposes, such as attracting consumers to buy, rent, lease, join, subscribe to, provide, or exchange products, goods, property, information, or services, or enabling or effecting, directly or indirectly, a commercial transaction.

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  4. Heart sink doctors

    OPEN ACCESS PEER-REVIEWED
    Published: October 4, 2021The rise in opioid prescribing in primary care represents a significant international public health challenge, associated with increased psychosocial problems, hospitalisations, and mortality.
    The intervention, the Campaign to Reduce Opioid Prescribing (CROP), entailed bimonthly, comparative, and practice-individualised feedback reports to practices, with persuasive messaging and suggested actions over 1 year. , During the intervention period, prescribing per 1,000 adults fell corresponding to 15,000 fewer patients prescribed opioids. These trends continued post-intervention, although at slower rates.

    Feedback may need to be sustained for maximum effect.

    There are large differences in opioid prescribing between practices, suggesting prescribing is driven by clinician habits rather than patient need.
    We delivered evidence-based and theory-informed feedback reports to 316 general practices in Yorkshire, UK, every 2 months for 1 year, intended to reduce opioid prescribing by prompting physicians to think twice before starting patients on opioid medication and to review patients not currently benefiting from the medication.
    15,000 fewer patients prescribed opioids at the end of the intervention year.
    Prescribing of strong opioids, total opioid prescriptions, and prescribing in high-risk groups generally fell, although effects lessened after the feedback stopped.

    Feedback may need to be sustained for maximum effect.
    October 4, 2021 [1–5]. Prescription opioid use in the US has fallen little from 2010 peaks, despite increased awareness Despite increased awareness of the potential harms in opioid prescribing, prescription rates remain historically high in both North America and Europe [12–14]

    Observed large variations in opioid prescribing, up to 10-fold in a UK study of primary care practices, suggests that physician habits and norms are a major driver, rather than patient need and evidence of benefit [.

    GP prescribing ‘habits and norms’ are a key factor in the increase, rather than ‘patient need and evidence of benefit’.

    Public Health England’s landmark 2019 review into prescription drug addiction concluded that one in four adults – over 11m adults in England – received a prescription for antidepressants, opioids, gabapentinoids, benzodiazepines or z-drugs in the previous year.

  5. John Read Ph.D.

    Psychiatry Through the Looking Glass

    SSRIS

    Tackling the Problem of Antidepressant Withdrawal
    Support for people struggling to get off antidepressants is long overdue.

    Posted October 10, 2021 

    https://www.psychologytoday.com/gb/blog/psychiatry-through-the-looking-glass/202110/tackling-the-problem-antidepressant-withdrawal

    This World Mental Health Day (October 10), nearly 8 million adults in England (17 percent of the adult population) will be on prescribed antidepressants. Sadly, none of them will receive any specialised help from the National Health Service (NHS) with the withdrawal symptoms that more than half of them will encounter when they try to come off the drugs.

    The number of people on antidepressants has risen every year, internationally, for 20 years. The theme for World Mental Health Day this year is “mental health in an unequal world.” In the case of psychiatric drugs, the usual problem of disadvantaged and marginalised groups not getting their fair share of resources is reversed. They are, in many cases, getting too many psychiatric drugs.

    In the U.S. and UK, for example, prescription rates of antidepressants are particularly high for women, older people, and people living in deprived areas. In the part of London where I live and work, Newham, about one in every three women over 60 is on antidepressants.
    These figures reflect the fact that mental health problems are, contrary to psychiatry’s dominant medical model, primarily caused by social adversities.

    Until very recently, governments had the excuse of ignorance for not doing anything about the millions of people suffering withdrawal effects from psychiatric drugs. The American Psychiatric Association (APA), drug companies, and, in the UK, the Royal College of Psychiatrists and the National Institute for Health and Care Excellence (NICE), had all reported, for two decades, that withdrawal from antidepressants was rare, mild, and lasted just one or two weeks. This meant that people trying to tell their doctor about their withdrawal effects were likely to be told their original problem, e,g, depression or anxiety, was returning

    With little or no help available from the NHS, or international equivalents, people have turned, in droves, to the internet for withdrawal support. There has been little research into these peer support communities. But my colleagues and I recently published a study following 13 facebook withdrawal support groups for a year. We found a total membership of 67,125, and an annual growth rate of 28 percent. Group members were 82.5 percent female, as were 80 percent of the administrators and moderators, all of whom are volunteers. The most common reason for seeking out help was failed doctor-led withdrawal.

    We concluded: “Further research should focus on the methods of support and tapering protocols used in these groups to enable improved, more informed support by clinicians. Support from governments and healthcare agencies is also needed, internationally, to address this issue.”

    Two years ago, I served on the expert advisory panel to a report by Public Health England (PHE), into “Dependence and Withdrawal Associated with some Prescribed Medicines.” Dr. James Davies (University of Roehampton) and I published a review of the research on antidepressant withdrawal for the PHE inquiry. We found that 56 percent of people experience withdrawal symptoms when trying to reduce or come off the drugs. Furthermore, nearly half (46 percent) of those people categorised the withdrawal symptoms as “severe,” and several studies reported that these symptoms could last for many months.

    Following the PHE report, the Royal College of Psychiatrists and NICE (but not the APA or pharmaceutical companies) have updated and corrected their guidance. Finally, more people—at least in the UK—will be told about the risks of severe, protracted withdrawal before deciding whether to take the drugs, and more people will be told that they need to come off very slowly, particularly towards the very end of the tapering process.

    Meanwhile, the UK’s psychotherapy, counselling, and psychology associations joined in and produced a “Guidance for Psychological Therapists: Enabling Conversations With Clients Taking or Withdrawing From Prescribed Psychiatric Drugs.” This is important because many therapists and psychologists have paid little attention to clients’ struggles with these issues, often because they see it as “the doctor’s business.”

    The PHE report called for dedicated local support services for people withdrawing from prescribed medicines, and a national helpline. I am now an advisor to the “NHS England and NHS Improvement” task force commissioned to implement these recommendations. In my view, it will be medically, morally, and financially negligent for the government to continue to ignore the long-denied needs of hundreds of thousands of people across the UK, predominantly women, older people, and poorer people.

    My international colleagues tell me that the UK is, on this issue at least, streets ahead of the rest of the world, which is only just beginning to acknowledged the problem exists.

    World Mental Health Day seems like an opportunity to shine a light on this epidemic of unnecessary suffering and the need for those who contributed to it to step up and help fix it.

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