RxISK Manifesto

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October 7, 2019 | 11 Comments

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  1. Re :-https://casereports.bmj.com/content/12/5/e228824
    It’s only about a decade since health workers have been obliged to gain consent for use of their information but it is farcical when an account like this can be written up , with consent obtained, without an accompanying account by the person herself. There is mention of what factors can contribute to suicidal ‘ideations’ (what’s wrong with ‘thoughts’) in general but no description of what specifically contributed in herown case – or from her about her reason for thinking of suicide The woman thanks the clinician for her care ! He claims to have had a long therapeutic relationship with her. All well and good but he was allowed to give her such a poisonous cocktail of drugs .
    The frightning amount of drugs she was given is incredible. The adverse effects of these in different combinations could have been highlighted in a part of the account
    the way accounts (cases)of people’s lives are written up may be couched in kindly terms , it may be honestly admitted that the author was criticised but there does need the massive cultural shift DH and DM propose just as was needed to gain rights to consent to consent or not publications.
    Maybe it is naively assumed or the fact willfully avoided that even ‘case’ histories can be skewed, clinicians will still lie for various reasons – unless independant coroboration (or not) is given in a setting where the person does not feel threatened, embarrassed or beholden to the clinician. It’s both a matter of respect and integrity of what is proposed as learning material which should be opely accessible to everyone.
    This article is described as open access but there are qualifications so am not copying the actual article – ref above

  2. Would people have suffered so much and for so long at the hands of J and J if the suggestions in the (our) Manifesto had been available for people to flag up concerns at an early stage? It seems easier for people in USA to take legal action – wonder why?
    Johnson & Johnson, Risperdal Maker Hit With $8B Verdict
    By The Associated Press
    Oct 8

    PHILADELPHIA — A Philadelphia jury on Tuesday awarded $8 billion in punitive damages against Johnson & Johnson and one if its subsidiaries over a drug the companies made that the plaintiff’s attorneys say is linked to the abnormal growth of female breast tissue in boys.

    Johnson and Johnson immediately denounced the award after the jury’s decision in the Court of Common pleas, saying it’s “excessive and unfounded” and vowing immediate action to overturn it.

    The antipsychotic drug Risperdal is at the center of the lawsuit, with the plaintiff’s attorneys arguing it’s linked to abnormal growth of female breast tissue in boys, an incurable condition known as gynecomastia.

    Johnson & Johnson used an organized scheme to make billions of dollars while illegally marketing and promoting the drug, attorneys Tom Kline and Jason Itkin said in a statement.

    Kline and Itkin said that Johnson & Johnson was “a corporation that valued profits over safety and profits over patients.” Thousands of lawsuits have been filed over the drug, but the attorneys said this was the first in which a jury decided whether to award punitive damages and came up with an amount.

    Johnson & Johnson said in a statement on its website it was confident that the award would be overturned, calling it “grossly disproportionate” with the initial compensatory damage award and “a clear violation of due process
    Johnson & Johnson said the court’s exclusion of key evidence left it unable to present a meaningful defense, including what they said was a drug label that “clearly and appropriately outlined the risks associated with the medicine” or Risperdal’s benefits for patients with serious mental illness. They also said the plaintiff’s attorneys failed to present any evidence of actual harm.

    “This decision is inconsistent with multiple determinations outside of Philadelphia regarding the adequacy of the Risperdal labeling, the medicine’s efficacy, and findings in support of the company,” Johnson & Johnson said. “We will be immediately moving to set aside this excessive and unfounded verdict.”

  3. The return of Vioxx: Can a drug once deemed deadly be relaunched to treat rare disease?

    By Damian Garde @damiangarde

    October 9, 2019

    https://www.statnews.com/2019/10/09/vioxx-relaunched-treat-hemophilia-rare-disease/

    Since its recall in 2004, the pain drug Vioxx has been a symbol of pharmaceutical danger, starring in countless daytime legal advertisements explaining how you, or perhaps a loved one, might be entitled to millions in settlement dollars. But one company believes the infamous drug deserves a second chance, and is plotting to resurrect the former blockbuster as a treatment for a rare, incurable condition.

  4. It is not only boys who may be vulnerable to the alleged injury of antipsychotic-induced hyper-prolactinaemia: with resultant gynaecomastia, and hence breast enlargement.

    Women recipients of such drugs may suffer from the same alleged vulnerability to exquisitely painful and grossly disfiguring breast enlargement.

    Prolactin levels can be monitored.

    Is anyone investigating what (possible) psychotropic drug damage may be/is caused to other endocrine systems, and how such endocrine injuries might be caused at tissue, cellular and/or sub-cellular level?

    Psychotropic drugs have been reported to produce mitochondrial toxicity.
    (Interference with our intra-cellular energy “power-houses”)
    Whether this is a causative factor in multi-systems / multi-organ adverse drug reactions is – (I believe) – unknown.

    In terms of endocrine pathophysiology, where would such injury located?

    Would it be in the hypothalamus, pituitary or endocrine/glands? – All of these?
    (Brain injuries and/or injuries to hormone producing glands/hormone responsive structures)?

    What are the implications of potential breast hyperplasia for men and women over many years of exposure to psycholeptic drugs?

    These are considered by some authors to be primarily drugs of behavioural control, not medicines correcting or reducing a disease process defined by measurable parameters.

    • Additional background, on ‘the Risperdal boys’

      J&J Sees Male Breasts And Quickly Settles Risperdal Suit

      Ed Silverman

      September 11, 2012

      https://www.forbes.com/sites/edsilverman/2012/09/11/jj-sees-male-breasts-and-quickly-settles-risperdal-suit/#3d9c95cdf14c

      Collectively, they have become known as the Risperdal Boys after a handful of the now-grown men agreed to participate in a photo shoot and interviews to help get their story out.

      Makers of Risperdal Sued for Breast Development in Boys

      By
      Barbara Liston

      July 21, 2017

      https://www.madinamerica.com/2017/07/risperdal-sued-breast-development-boys/

    • Intended for healthcare professionals

      Consultant who put risperidone in wife’s tea without her knowledge is suspended for three months
      BMJ 2019; 367 doi: https://doi.org/10.1136/bmj.l6088 (Published 17 October 2019)
      Cite this as: BMJ 2019;367:l6088

      Responses
      Clare Dyer
      Author affiliations
      A locum consultant who told his wife’s GP that he had been slipping the antipsychotic drug risperidone covertly into her tea—and who asked the GP for more risperidone so that he could continue doing so—has been suspended from the UK medical register for three months.

      Chandranath Sarkar was originally suspended for four months in 2018 by a different panel of the medical practitioners tribunal service, but he appealed to the High Court. He argued that his right to stay in the UK would be threatened by suspension, since his tier 2 visa required him to be working in his current post with Cwm Taf Health Board.

      The four month suspension was also appealed by the Professional Standards Authority for Health and Social Care (PSA), for being too lenient, although the General ….(sorry cant get the rest up)

      and at the same hospital where services were known to be dangerous….

      8 October 2019 at 5:30am
      Report into maternity care at scandal-hit Cwm Taf Morgannwg health board to be published
      JAMES CRICHTON-SMITH HEALTH REPORTER, ITV WALES
      Stock photo of maternity ward
      It followed revelations that serious incidents – including the deaths and serious injury of babies – were not being reported Credit: PA
      The first report from an expert panel looking into maternity services at Cwm Taf Morgannwg health board will be published today.

      An Independent Maternity Service Oversight Panel was set up following a damning report into the state of maternity services at the south Wales health board.

      It followed revelations that serious incidents – including the deaths and serious injury of babies – in the maternity units of the Royal Glamorgan Hospital in Llantrisant and Prince Charles Hospital in Merthyr Tydfil were not being reported properly.

      Bereaved mother in baby deaths inquiry speaks out
      In their own words: The parents at the centre of the Cwm Taf baby scandal
      The report by the Royal College of Midwives and the Royal College of Obstetricians and Gynaecologists found systemic failures of governance in the service and health board.

      The oversight panel, led by Mick Giannasi, is now reviewing cases dating back to 2010 to try and establish what went wrong at the health board.

      Cwm Taf’s maternity services are now in special measures, which means there is direct Welsh Government oversight of performance. The health board as a whole has also been put into targeted intervention, meaning there is more scrutiny being placed on it to improve.

      Health board boss Allison Williams resigns following maternity scandal
      Mother fears giving birth after son delivered stillborn
      Last updated Tue 8 Oct 2019
      HEALTH WALES
      Wales
      8 October 2019 at 5:30am
      Report into maternity care at scandal-hit Cwm Taf Morgannwg health board to be published
      JAMES CRICHTON-SMITH HEALTH REPORTER, ITV WALES
      Stock photo of maternity ward
      It followed revelations that serious incidents – including the deaths and serious injury of babies – were not being reported Credit: PA
      The first report from an expert panel looking into maternity services at Cwm Taf Morgannwg health board will be published today.

      An Independent Maternity Service Oversight Panel was set up following a damning report into the state of maternity services at the south Wales health board.

      It followed revelations that serious incidents – including the deaths and serious injury of babies – in the maternity units of the Royal Glamorgan Hospital in Llantrisant and Prince Charles Hospital in Merthyr Tydfil were not being reported properly.

      Bereaved mother in baby deaths inquiry speaks out
      In their own words: The parents at the centre of the Cwm Taf baby scandal
      The report by the Royal College of Midwives and the Royal College of Obstetricians and Gynaecologists found systemic failures of governance in the service and health board.

      The oversight panel, led by Mick Giannasi, is now reviewing cases dating back to 2010 to try and establish what went wrong at the health board.

      Cwm Taf’s maternity services are now in special measures, which means there is direct Welsh Government oversight of performance. The health board as a whole has also been put into targeted intervention, meaning there is more scrutiny being placed on it to improve.

      Health board boss Allison Williams resigns following maternity scandal
      Mother fears giving birth after son delivered stillborn
      Last updated Tue 8 Oct 2019
      HEALTH WALES

  5. Susanne, would I be right in thinking that the J and J subsidiary is their mental health drug department, Janssen? And it was they who promoted Risperidal. In the experience of our son who took it for short periods two or three times and found the effects to be appalling. The first time he took it, to soothe the effects of RoAccutane isotretinoin, (would you believe…) he looked as though he was having a fit, mouth contorted, twitching etc, what we know now to be AKATHISIA, but of course didn’t then. Janssen we believe, funded an Early Intervention project under Suicide Safer projects in universities,and the EI was to treat psychosis fast before it got going, but my question to the Lead on this project was, ‘how sure are you that it’s actual psychosis and not an akathisiac reaction to a previously taken SSRI etc. With the Janssen Risperidal links, it’s surely likely that that drug was the first choice for the ‘early intervenerrs’. I asked if they knew what AKATHISIA was, and my concerns were dismissed. They reassured me by saying they only used low titrations. As if that could make a lot of difference…. in our experience it’s still a ghastly drug as regards side effects.

    • Hi Heather
      Yes you right – you may fingd this ‘interesting’ -they are one of the pharma companies who are duping people and using them to hype their companies reputations. Lots of them are doing it as I guess you know by doing supposed good works and deeds which could also be a way of avoiding taxes but i’m not up on that (see Kantor funder of Freud-Kantor centre of excellence – one of the richest Russion oligarchs funds child developemnt projects))
      The woman herself is remarkable and all best wishes to her but wonder how she got involved with the Janssen project – are healthworkers channelling people into them….
      JANSSEN GLOBAL
      change location >

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      Using Art to Challenge the Stigma of Mental Illness
      DEC 07, 2018

      Janssen proudly features artwork created by people affected by the illnesses and diseases we are dedicated to treating and preventing. Please visit our art gallery to learn more about the artists and view more artwork.
      Michelle Hammer describes herself as “a schizophrenic New Yorker trying to change the way New York City sees mental health.”

      To achieve that mission, Michelle draws upon her passion for design — creating art while advocating to end the stigma associated with mental illness.
      Her approach to creating the complex art that has become her signature style starts quite simply, with a sketch book and magic markers. Once an original drawing is complete, she photographs it, uploads it to her computer and continues to add multiple layers digitally. Each piece of art becomes a visual reminder of what was going on in her mind when it was created
      And, while Michelle recognized early on that she had a passion for art, it wasn’t always clear to her that she had an illness. As a teenager, Michelle found it extremely difficult to trust anyone around her, including her family. After graduating high school and going to college, the same paranoid feelings — this time about her roommate — resurfaced. This is when Michelle realized she needed professional help. It took a few years to find a doctor who correctly diagnosed her condition. But, then the clouds parted.

      “Being diagnosed with schizophrenia was the best thing that ever happened to me,” she says, “because then I could be treated in the right way.”

      Featuring Artwork in Fashion to Raise Awareness

      In May 2015, at age 27, she combined her artistic talents and personal experiences to launch Schizophrenic.NYC, a clothing line with the mission of reducing stigma by starting conversations about mental health.

      “My art and my advocacy work together. My goal is to just start the conversation. Let’s just end the stigma. Let’s just do it
      In addition to the colorful graphic designs based on the concept of Rorschach Test ink splatters, Michelle adds motivational slogans such as “It’s Not a Delusion, You Are Incredible” and “Don’t Be Paranoid, You Look Great.” Michelle sells her artwork and clothing on her website and at pop-up shops throughout New York.
      Making an Impact by Furthering the Conversation

      For the past two years, she has also exhibited her art at the Fountain House Gallery, which supports New York City artists living and working with mental illness — using their art to challenge the
      To further that conversation, Michelle has also participated in the HealtheVoices™ Conference, a groundbreaking leadership conference, created by Janssen, aimed at providing valuable content, thought-provoking conversation and networking opportunities for online health advocates who use social platforms to advocate for themselves and their community
      “HealtheVoices™ has been a great opportunity,” she says, noting that she has participated in the conference the past two years. “It has given me such a confidence
      Not too long ago, Michelle didn’t know what the future held for her. Today, she is a confident, successful, New York City businesswoman who has turned her schizophrenia diagnosis into an opportunity to reduce stigma and improve life for others who are also living with mental illness.
      “I am me. I am Michelle. I am a schizophrenic. I have brown hair. I live in Queens. It’s all a part of me,” she declares. “My art and my advocacy work together. My goal is to just start the conversation. Let’s just end the stigma. Let’s just do it
      You can find Michelle Hammer on Instagram (Schizophrenic.NYC), Twitter (@SchizophrenicNY), and Facebook (Schizophrenic NYC), as well as on her website (Schizophrenic.NYC).

  6. AntiDepAware Retweeted

    John Read‏ @ReadReadj 40m

    NICE GUIDELINES (UK) FINALLY BECOME EVIDENCE-BASED ON ANTIDEPRESSANTS AFTER YEARS OF RELYING ON OPINIONS OF A FEW PSYCHIATRISTS. Well done to all concerned in achieving this. Antidepressants can cause severe side effects that last months https://mol.im/a/7560805  via @MailOnline

    Antidepressants can cause severe side effects lasting months, health bosses admit for the first time

    NHS watchdog made clear coming off the pills can cause long-lasting symptoms
    All patients will now be warned of the risks when they start on the medication
    Campaigners hope this will significantly reduce the over-use of antidepressants 

    By Ben Spencer Medical Correspondent For The Daily Mail

    Published: 00:01, 11 October 2019 | Updated: 00:07, 11 October 2019

    https://www.dailymail.co.uk/news/article-7560805/Antidepressants-cause-severe-effects-lasting-months-health-bosses-admit-time.html

    A step in the right direction, but, unfortunately, no mention of ‘long-lasting symptoms’ aka RxISK Manifesto..

    Antidepressants, which include common brands such as Prozac, Cipramil and Seroxat, are proven to be an effective way of treating moderate to severe depression.

    Also, a questionable statement?

  7. Why are doctors being let off the hook? Some pharma companies trawled the medical profession to look for allies. Maybe the they are willing to take the hit as they can afford it and they cant afford to potentially lose the doctors who are the ones actually doing the prescribing..Janssen is in Rwanda pushing for people diagnosed with ‘schizophrenia’ to be injected rather than given pills – which can be junked or cut of course. The ‘reason being the scarcity of psychs to ‘care for’ people. They are still despite the scandals all over the mental health services in UK. Researchers have to apply for their funding but it is the company which decided who gets it.
    Who would have taken this junk had they known – the bit re ‘if you have allergies is disgusting – people would not necessarily know that they had any but could be blamed as not checking – always a sewer to crawl down
    .http://www.janssenprescriptionassistance.com/risperdal-cost-assistancehttps:/
    /pharmaphorum.com/views-and-analysis/janssen-mental-health-psychiatry/
    https://www.kingsfund.org.uk/publications/outcomes-mental-health-services
    https://www.lshtm.ac.uk/study/fees-funding/funding-scholarships/19-20-jj-gmh
    https://www.prnewswire.com/news-releases/janssen-funds-new-global-leadership-initiative-on-brain-health-300296898.html
    https://www.jnj.com/johnson-johnson-announces-series-of-collaborations-aimed-at-transforming-mental-health-care-in-low-resource-settings Many more…..
    and the one we all know about now
    https://www.irishtimes.com/business/manufacturing/johnson-johnson-fined-8bn-over-marketing-of-anti-psychotic-drug-1.4044979
    By the way talking of withdrawal where are the spcialists Raj Persaud was supposed to be setting up? He’s the psych who was found guilty of pagiarism some while ago but now in a position of ,some little it seems,influence at coll of psychs –

  8. THIS SITE IS INTENDED FOR HEALTH PROFESSIONALs
    – (as I guess we all consider ourselves to be – and we need to have access to all info which may effect our lives – including the opinions of those who ‘treat’ us) Ref to David Healy below .

    NICE revises antidepressant guidance to warn of ‘severe’ withdrawal symptoms
    17 October 2019 By Isobel Sims
    Venlafaxine – Antidepressant – SNRI – Online
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    NICE has revised its depression guidelines to warn of ‘severe’ and lengthy antidepressant withdrawal symptoms, having originally said such symptoms were ‘mild’.

    The updated guidance on treating depression in adults now includes statements on withdrawal symptoms, clarifying that symptoms may be severe and last for months in some patients.

    This is a revision of the original guidance, which advised that symptoms are generally mild and self-limiting over the course of a week.

    NICE delayed the release of the full guideline update in 2018 after the draft guideline came under scrutiny by doctors who said that the ‘flawed’ methodology and out-of-date evidence would ‘seriously impede’ patient care and choice.

    A second consultation was launched last year to address concerns raised by mental health leaders before publication.

    The update also follows a position statement released by the Royal College of Psychiatrists in May, which recommended that NICE guidelines should acknowledge the potential for severe withdrawal and provide evidence-based guidance for gradual withdrawal from antidepressants.

    The updated recommendations say that patients should be advised to talk to their GP before coming off their antidepressants.

    They also say that patients may experience symptoms such as restlessness, trouble sleeping and sweating if they miss a dose or suddenly stop their medication, and that although these symptoms are usually mild and self-limiting, they may last for months and be more severe in some patients.

    Dr Paul Chrisp, director of the Centre for Guidelines at NICE, said: ‘We have amended the guideline to recognise the emerging evidence on the severity and duration of antidepressant withdrawal symptoms.

    ‘The updated recommendations are in line with the statement from the Royal College of Psychiatrists and were agreed by our independent committee.’

    The full guideline update is still in progress, with a publication date to be confirmed.

    READERS’ COMMENTS (9)
    Vinci Ho
    Vinci Ho | GP Partner/Principal17 Oct 2019 10:25am

    It is amazing how long it takes for NICE to come out with an updated and amended version of this guidance since these controversies arose last year( and still yet to publish this long overdue guidance ).
    It is kind of alluding that it was caught off guard completely in the first place and did not foresee and expect such a level of backlash from colleagues. Once again , another example in a professional establishment of having a blind spot keeping it out of touch with our frontline colleagues.
    One wonder how many more lessons NICE has to learn before it is introspective enough to change its ‘culture’ and mechanism of arriving at any new guidance
    Sensible Doc | GP Partner/Principal17 Oct 2019 10:50am

    Isn’t this just scare-mongering?

    To quote NICE: “…there is
    a clear patient voice, as well as support groups, charities and organisations that have highlighted that adverse effects can be particularly
    severe and/or long-lasting …
    While there is some published research showing that symptoms on and after stopping antidepressants can persist for several weeks and longer (Horowitz and Taylor, 2019; Fava et al 2018), there are limited high-quality data in this area.”

    In other words a lobby group has successfully petitioned NICE to increase liability on GPs for side effects that are unusual. NICE has done what it always does and publish edicts on poor quality evidence which we will no doubt be measured against the next time a complaint comes in. NICE is past it’s sell-by date and should be closed.

    CensorshipDistortsReality | Locum GP17 Oct 2019 1:21pm

    I don’t come across ‘severe withdrawal’ in anything but a very small atypical and vocal minority of patients in clinical practice. I don’t find this helpful. Pressure groups and online forums should not be informing NICE guidance. It’s just the world we live in..those who shout loudest get their way. Opiates give ‘severe withdrawal symptoms’ – SSRIs commonly do not

    keitflyer | Locum GP17 Oct 2019 4:45pm

    Of course ssris have bad withdrawal symptoms, as is obvious from the fact that patients by and large dont successfully stop them. We now have around 10% of the adult population taking them, in most cases after their gp dishes out a prescription when patients present with adjustment disorder for which they dont actually work. Patients are rarely warned about the severe side effects and the difficulty coming off them. See anything by David Healy or Peter Goetsche on this subject. We should be ashamed of ourselves in my opinion.

    CensorshipDistortsReality | Locum GP17 Oct 2019 6:06pm

    keitflyer | Locum GP17 Oct 2019 4:45pm
    Do you actually prescribe these things? People stop these them all the time, often they just stop picking them up and don’t even wean off. Given the number of people taking them it’s frankly more surprising how little trouble they cause. Are you a GP?

    David Banner
    David Banner | GP Partner/Principal17 Oct 2019 9:31pm

    Re DeadEndDr,

    Totally agree. We find huge numbers of patients who have stopped taking SSRIs contrary to advice without a jot of trouble. They rock up a year later depressed again looking for more. Compliance has always been poor with these drugs.
    The tiny vocal minority who bitterly complain of withdrawal issues are the usual suspects, often heartsinks who have side effects from paracetamol, pollute social media with their medical mishap nightmares, and should never have received an SSRI in the first place (though they’re often prescribed in desperation 30 minutes into a 10 minute consultation)

    UNSUITABLE OR OFFENSIVE? REPORT THIS COMMENT

    CensorshipDistortsReality | Locum GP18 Oct 2019 1:47am

    This comment has been deleted
    ..what did i say ??

    UNSUITABLE OR OFFENSIVE? REPORT THIS COMMENT

    Harry | GP Partner/Principal18 Oct 2019 8:58am

    “Nice” should be disbanded. As an arm of the nhs, and, by extension, of the government, their guidelines are fraught with conflicts of interest. Their “panels” are of questionable quality not least because they utilise “lay members” lol as well as other people such as pharmacists and quango academics. The medical colleges and specialist medical societies should come up with guidelines for their respective specialities as they see fit, as they do in other civilised and respected countries around the world. What’s happening with NICE is some governmental politburo with its own hidden agendas sets the pace for everyone and this lowers standards. In many instances guidelines become outdated and it may be months or years before the latest research manifests in useful new guidelines. No internationally respected scientific body utilises the “NICE guidelines” as a benchmark for anything. These “guidelines” are useful only for the uk government to pretend that they are some sort of gold standard (when they’re not) and in order to keep uk doctors on a leash. People should really start to wake up a little.

    Dr Cynic | Locum GP18 Oct 2019 10:44am

    keitflyer | Locum GP17 Oct 2019 4:45pm
    i also have doubts as if this is a legit practicing GP

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