Twas the NICE before Christmas.

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December 22, 2022 | 15 Comments

To the Sounds of a Drum © Nina Otulakowski November 2022

This letter, which has had no response, needs to be read in conjunction with Can you Hear the Suzerain Call?

Letter to Dr S Roberts, CEO, Ms Nebhrajani, Chair, NICE
November 30 2022

Dear Drs Roberts and Ms. Nebhrajani

I wrote to your predecessors Dr Haslam and Mr. Dillon just under 3 years ago about the issues of ghostwriting in clinical trials along with lack of access to trial data – the material on which NICE base their Guidelines.  Mr. Dillon replied, acknowledging the issue, but adding it was difficult to see what NICE could do (1).

Over a decade earlier in 2004, with NICE in the middle of writing Guidelines on the treatment of paediatric depression, a crisis blew up centred on the ghostwriting of clinical trials and lack of access to trial data. Evidence of a deliberate intention to mislead doctors and the public in the case of a ghostwritten publication of Study 329, a study of paroxetine in adolescent depression, led New York State to take a fraud action against GlaxoSmithKline (GSK). Study 329 also had a part in a later Department of Justice action against GSK that was resolved for $3 Billion.

This crisis, in addition, produced evidence of a doubling of suicidal event rates in adolescents on active treatment compared to placebo.  Around 2004-2006, pretty well the entire literature on paediatric depression was company written and constituted the greatest known divide, to me at least, in any branch of science between what the published literature said and what the data from trials, when accessed, indicated.

These events led to a celebrated Lancet editorial in June 2004 – Depressing Research (2). Between the lines, this editorial appeared to ask if it was possible, against the backdrop of a comprehensively ghostwritten literature at odds with the data it purported to represent, to write any guidelines for anything.

The NICE Guideline writers involved in the Lancet editorial appear to have been advised to adopt a more politically mature position.  NICE, presented with an opportunity to advance the health of all, continued to do as it had previously done – basing its Guidelines on a dodgy literature, making them essentially a free marketing tool for pharmaceutical companies.

I mentioned these points at a House of Commons Health Select Committee in 2004. Richard Horton, Lancet Editor, and Iain Chalmers, Cochrane Collaboration Founder, rushed in to assure the committee that these problems were rare and only applied to peripheral journals – the New England Journal of Medicine has been one of the lead offenders for over a decade.

Cochrane also opted for political maturity and continued to view company studies as valid evidence. When following a complaint to the European Ombudsman Professor Peter Gøtzsche secured access through EMA to company Clinical Study Reports, Cochrane continued to prefer ghostwritten articles. This arguably contributed a little over a decade later to a collapse of Cochrane’s reputation in many quarters.

FDA and MHRA, who had approved fluoxetine for depressed minors before the 2004 crisis blew up, rushed to assure the world that doctors could use it. The two published fluoxetine trials underpinning approval were company written and claimed efficacy, where FDA reviews report them as negative on their primary outcome.

Peter Gøtzsche and I have recently written an article, linked below, reanalyzing the data from the original fluoxetine trials in children and young people (3). It details the suicidal events, as well as cardiac and other problems found hidden in those trials, problems that kill children, in addition to confirming that fluoxetine is ineffectual.

You should know that in 2002 FDA issued an approvable letter for paroxetine, on the basis of 3 negative trials. This approval was aborted when the 2004 crisis blew up, but it was too much it seems for regulators to admit to a prior mistake in the case of fluoxetine.

FDA also agreed with GSK not to mention these negative trials in the label of paroxetine. It seems likely that GSK and other companies were acutely aware they could get sued for fraud if the label mentioned Study 329 was negative given their published claims that it demonstrated paroxetine worked well and was safe.

In a 2008 article, Erick Turner, who had formerly worked in FDA, along with colleagues showed that one third of negative trials done in adults with antidepressants then on the market were published as positive – just as Study 329 had been, with no mention of this in the label of these drugs.  FDA have never commented on any of these articles.

Meta-analyses, by Cipriani and others, have since argued we should think of using sertraline as a first line antidepressant.  This makes some sense when looking at Turner’s table of published results.  Looking at Turner’s table of FDA reviews, sertraline is the last drug anyone would use.

There is one study of fluoxetine in adolescents, run under the auspices of the NIH, but run on Lilly headed forms and rating scales. This has 34 suicidal events on fluoxetine compared to 3 on placebo, something the 7 publications on this trial side-step. Duke University, listed as holding the trial data, claim the adverse event data has all been destroyed.

As long ago as 2016, Jeremy Hunt, when Minister for Health said:

“Children’s mental health is possibly the biggest single area of weakness in NHS provision at the moment” (4).

An outcome like this is surely to be expected when services are trying to operate on the basis of a published literature and guidelines that assure them of one set of outcomes, when the inaccessible data suggest exactly the opposite will happen.  Guidelines that palter with us in a double sense – that keep the word of promise to our ears but break it to our hope.

Things have got worse since with the National Institute of Health and Care Research suggesting that doctors, in the habit of dishing out these medicines to minors, are paying little heed to NICE Guidelines (5).  The NICE Guidelines recommend referring to psychotherapy for milder cases, unaware that psychotherapists commonly recommend antidepressants. The recommendation to reserve these drugs for severer cases of depression, likely suggests to many that if they work for severer cases, they will work for milder cases.  Exactly this principle has underpinned pharmaceutical company marketing strategies for drugs like alprazolam.

Many children given these drugs, while on waiting lists, will present to mental health services with much more disorganized behaviour than if left untreated. They present to clinicians who have no training in how to assess or manage such consequences and who are likely to prescribe further medicines. This situation has recently led the New York Times to write a feature on adolescents, primarily women, who end up on up to ten psychotropic drugs simultaneously with no obvious benefit (6). The same is happening in Europe (7).

The NIHR research makes clear that the UK is not spared. This year’s Office of National Statistics (ONS) figures show a recent increase in suicides in females under the age of 24 in the UK, a sufficiently clear cut change to attract a specific ONS editorial comment (8).

Greta Thunberg’s generation who are doing so much to draw our attention to the polluting effects of an excessive use of chemicals on the outer environment are having their inner environment polluted to a greater extent than ever before.

The BMJ have just published a piece on the need to combat the infodemic of misinformation we have seen with COVID and its vaccines (9). There is no better example of a misinformation infodemic than the trials of antidepressants in adolescents. There are few, if any, anti-vaxx groups, with the resources to match pharmaceutical company capacities to create a mismatch between reality and propaganda.

I am copying MHRA, BMJ and other professional bodies in to this letter. When initially drafting this, I had little hope that any of you are likely to do anything, let alone collaborate to solve this problem. I think I have even less hope now with the establishment of the Vaccine Taskforce Model to tackle Health Challenges (10). Regretfully, writing is more a case of letting the public see that nothing is being done or likely to be done about a problem outlined here that all parties acknowledge is happening. The situation seems more likely to get worse.

Yours sincerely

David Healy MD FRCPsych

Cc

MHRA: J Raine
BMJ: K Abbasi. M McKee
Royal Coll Psychiatrists: A James
Royal Coll Paediatrics: C Kingdon  health.policy@rcpch.ac.uk
British Medical Association:  P Banfield. M McKee
Minister for Health UK: S Barclay
Minister for Mental Health Scotland: K Stewart

References Cited:

  1. Andrew Dillon Correspondence re Ghostwriting and Access to Data.
  2. Whittington C, Kendall T, Fonagy P et al. Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data.  2004; 363: 1341-1345
  3. Gøtzsche and Healy: Restoring the two pivotal fluoxetine trials.
  4. Gammie J, Linton S. Hunt vows to act on NHS’s biggest area of weakness. Health Services Journal 2016.
  5. National Institute of Health and Care Research: Antidepressants for Children.
  6. New York Times 2022. This Teen was Prescribed Ten Psychotropic Drugs.
  7. Varimo et al 2022. Polypharmacy in children and adolescents. Nordic J Psychiatry.
  8. ONS 2022. Office of National Statistics Suicides in England and Wales
  9. Wang et al 2022 BMJ Infodemic
  10. Vaccine Taskforce Model to tackle Health Challenges – Gov.UK

See Can You Hear the Call of the Suzerain? for the significance of these images.

 

 



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Comments

  1. An entire treatise on logical fallacies could be written using just examples culled from that BMJ paper. Some examples follow:

    Flipping the script:

    “Some [covid skeptic organizations] benefit from generous funding from those opposed to what they term ‘big government.’”

    Arguing from authority:

    “Inevitably, given the complex technical issues, differentiating fact from fiction can be difficult.”

    Guilt by association:

    “This was set in the Brussels Declaration, which was drafted with substantial input from the tobacco companies.”

    Begging the question:

    “In times of crisis, people are more susceptible to misinformation, disinformation, and conspiracy theories, probably because their important psychological needs are unfulfilled, leading to frustration.”

    Straw man argument:

    “5G technology having deleterious health effects were also mentioned.”

    More flipping the script:

    “Given the lack of transparency in allowing academic researchers to examine the potential harms of these platforms…”

    The piece mentions the tobacco companies three times but never gets around to telling us that forty-five percent of the candidates and lobbying groups receiving money from Pfizer — the nation’s biggest pharmaceutical donor since 2010 –have also received money from Altria, the parent company of R.J. Reynolds.

    These people hate us.

    Reply

  2. Check your inbox Prof Healy!
    I can’t believe there wont be be a reply from someone nice at NICE along the lines:

    Dear Prof Healy
    Thank you for your letter.
    We have since looked at your peer-reviewed article that shows that fluoxetine is useless and perhaps dangerous in kids and adolescents. We will be revising our guidance to take this into account.

    Reply

  3. I like to be quite specific, and not too wordy, and I would like to Herald Peter Gordon who not only attempted to take his life with Paroxetine, but who was openly and publicly thoroughly distressed from persons, Simon Wessely, Wendy Burn, John Crichton from the Royal College of Psychiatrists.

    https://holeousia.com/2022/12/14/attacks-on-antidepressants/

    https://holeousia.com/2022/12/21/promulgating-therapeutic-recommendations/

    https://holeousia.com/2022/12/09/a-generation-in-crisis/

    Peter has a wide variety of interests with wonderful cinematography on Scottish history, architecture, wildlife, researched with love and dedication.

    https://holeousia.com/about-me/

    Peter’s story about Paroxetine has been widely reported in the Press; you might have thought he would disappear quietly, but how enormously impressive that despite his catastrophic experience, he can meander quietly along doing what he does that probably keeps him quite sane.

    Messrs. Above, who put Peter in an impossible situation, should probably have been sued and it is unlikely that that the Other Messrs. Above, were even aware of UK Litigation against GSK by a group of 105 litigants.

    The failure of that UK litigation was down to no appetite in the UK for UK litigation.

    Reply

  4. Extraordinary , (maybe not), that only 5 responses were published by Thebmj
    to
    Covid Inquiry
    Understanding and neutralising covid-19 misinformation and disinformation
    BMJ 2022; 379 doi: https://doi.org/10.1136/bmj-2022-070331 (Published 22 November 2022)-

    1 was A defence by the authors against the criticisms made by the targets of their article .

    4 were responses by the main targets of the article

    I know for sure that at least 1 more critical response was not published We can have no idea how many critical responses to the article, or supportive for that matter , were not published . (This applies to all journals, blogs and so on of course )But it could be suspected, rightly or wrongly, that there was a bit of censorship going on when in other outlets there was a great deal of anger expressed against such a shocking decision to it.

    Reply

  5. The last two sentences of this letter says it all. Indeed I would have phrased the last one as ‘The situation can only get worse’.
    I see this as inevitable. This is something that I think needs to be better understood so as to avoid waisting time tilting at windmills (fighting imaginary enemies).
    To use an analogy. After a number of years a computer system may no longer meet all the new needs of its users. It takes increasing amounts of time to upgrade it further and the software has had so many ad hoc fixes that the whole system is a nightmare to maintain. Eventually these failings impacts on the productivity of the company or organisation. It serves no useful purpose to holla and shout at the IT guys! It is no fault of theirs that you’re locked out of your database or what-ever. The only solution is to start with a fresh sheet of paper and design a new system (or go out of businesses).
    Likewise. Our social/economic world is a complex system of interdepend information systems. Analogously, the organization software are the thick files of policy notes, which describe each incumbent’s duties and responsibilities. Like computer software they often get modified from time to time to keep up with changes in the world around us. Like a computer system, over time the organization becomes evermore moribund in the execution of it’s functions to further it’s original raison d’etre . Nearly all our social/economic/science systems and regulatory systems are now moribund and very close to death.
    Against this mêlée played out on the MSM it is way too easy to see the liveware (human individuals) who hold office in these organizations as the problem itself. For they like we, are only endeavouring to satisfy their Maslow’s hierarchy of needs.[1] It is wise to keep separate too, any thoughts as to their competence, morality, etc. and realise such pondering waists thinking time which can be better used for other things. Also, banish thoughts that removing one from their post would help, it only opens up a slot for another equally as bad or worse replacement. Personally, I like to avoid the frustration such musings tend to evoke, it drains one of the energy to take gleeful action when ever a crack opens.
    In the higher echelons for whom all of Manslow needs are especially met and assured for life, they too seek to simplify and reduce uncertainties for their genetic descendants (if freedom from illusions and delusions permit).
    In short. It is just the growing infirmity of the systems that can not prevent bad decisions from within (brought on by trying to adapt to changes from without) being enacted. Furthermore, guided by the illusions and delusions from higher up the hierarchy of power and influence will insure things will get far, far worse before they get better.
    The UK’s Vaccine Taskforce Model initiative is connected to (and subservient to) the World Health Organization’s ‘One Health’ initiative.[2] Built into this is vaccine passports which will no doubt include social credit scoring, carbon footprint allowances, and digital currency etc. Obesity ceases to be a problem too if one can limit an individual’s buying of food at the click of an administrators mouse. Worried your patent may get addicted if you prescribe pain killers? Its OK! We are developing opioid vaccines against addiction, our app will spot addiction before you do and intervene on your behalf. [3] Why don’t they add statins to the water whilst they’re at it? It could save millions of lives and the UCL can create a computer model to prove it. Oh isn’t technology wonderful for the wrong reasons sometimes.
    Although history never repeats exactly, the pattern appears to remains the same (as I have mentioned on previous post here). They say: to be fore warned is to be fore armed, so for those who may like a little light reading over Christmas to gain more insight as to ‘what’ the real enemy is, I recommend:
    The Fate of Empires and Search for Survival by Sir John Glubb (1976) http://people.uncw.edu/kozloffm/glubb.pdf

    References:
    [1] Maslow’s hierarchy of needs
    https://en.wikipedia.org/wiki/Maslow%27s_hierarchy_of_needs
    [2] One Health: Approach for action against neglected tropical diseases 2021–2030
    https://www.google.com/search?q=who+one+health+approach+pdf&rlz=1C5CHFA_enGB982GB985&oq=who+%22one+health%22&aqs=chrome.6.69i57j0i512l9.27887j0j15&sourceid=chrome&ie=UTF-8
    [3] An Advance in Prescription Opioid Vaccines: Overdose Mortality Reduction and Extraordinary Alteration of Drug Half-Life
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6434689/

    Reply

  6. What a truly depressing read.

    As someone who’s been diagnosed with PSSD, I find that people, including Drs, still disbelieve me based on the notion that if PSSD existed, it would’ve been flagged in drug trials or the MHRA would catch it via the Yellow Card scheme. When I point out the institutional impotence, complacency and corruption similar to that outlined in this letter, I am disbelieved again.

    On social media, I have been following the responses from medical professionals to the news that adolescents are increasingly being prescribed SSRIs without following NICE guidelines. Faced with ridiculous waiting lists for teens needing MH services, professionals ask ‘What else can we do?’, rather than ask why they think that NICE suggest extreme caution when prescribing SSRIs to minors in the first place.

    Reply

    • ‘What else can we do?’

      As I see it, teenagers per sa have not changed much over the decades. They still posses strong motivations to ‘feel they fit in’ to the world as they perceive it and are also under the same great peer pressure (as we experienced) to conform to whatever they think they need to conform to.
      The internet has replaced the magazines and TV commercials which tried beguiling us as to what to wear, what records to buy and so on. Just like some of us growing up back in the 1960’s, they too receive reassurances equivalent to “10 minutes from the sirens going off is plenty of time to get out of your gym gear and under your school desk” and we perceive clearly that the teachers were unwilling to discuss any question about that advice which didn’t make sense to us.

      The difference back then was we still had a nuclear family of the social type. By eating together round a table and frequently visiting relatives, there was ample time available for teenagers to express what conflicting information was bothering them and seek the views from older members of the family to help them unknot the pickle for themselves. A lot of teenage MH problems appear to me not due to anything organically wrong with their brains but simply to be a case of their immature and developing minds becoming log jambed with negatives and double binds. Also, during late teens their neurons are undergoing another processes of pruning so it is important that they receive prompt, meaningful help.

      In short, families had more opportunity to care for each other back then as it takes time to listen attentively before one can ask the ‘right’ questions, which by the very act of thinking of the answers they start to see their own solutions. There is much about how the world works that they can’t be expected to know yet and is a habit that doesn’t come naturally, it needs to be learnt. More over, state schools do not teach critical reasoning and they covertly actively discourage it. And pseudo skepticism has replaced true skepticism.

      Some of us are beginning to wake up to the fact they we really do need to take back all those responsibilities which are better held in our own hands rather than our impersonal, faceless governments. The UK government has even appointed a Loneliness Minister rather than acknowledge the causes. [1] It should not be the job of the family health provider to cope with societal/government imbalances. Even if a troubled individual does get to see a specialist, the system appear designed to neuter the best efforts of the therapist.

      One might also ask why religious leaders no longer mingle with their flocks, offering a listening ear, practical suggestions, opening doors (enabling), reassurance and the willingness to answer difficult questions.

      Well. Its easy to point to problems and as for every problem there is a solution that is simple, neat—and wrong — I won’t offer any. However, I will ask a question. Has such a family with a teenagers suffering problems have thought of giving him or her a copy of Dr Eric Bern’s book entitled “What Do You Say After You Have Said Hallo?” ? It lays out a simple schema of the mind, enabling one to discover how to use one’s head properly, both to think coherently and talk with other people on a level playing field. This is an area that most teens struggle with (although the book is not aimed at any particular age group). It is written in an easy to read style that anyone can follow and comprehend. People have noted that it was hard to pick up but even harder to put down once they started reading, and the whole family then has to read it, which I suppose is why it has become a classic.
      In my opinion it should be on every schools reading list. Of all the books I’ve lent to people (and over the years I have lent many dozens) this is the one I never get back and I’m glad of it.

      Likewise, a good book on critical reasoning skills is a must to give a teenager, to make up for scholastic failing. Who coming out of college today can dissect Yuxi Wang and colleagues BMJ article like Patrick D Hahn did? And by his own admission, he wasn’t even trying that hard. It is a skill that most people today automatically assume they have but don’t.

      We need to carry on doing what we are doing here and encourage other people to care more for each other. For homo sapiens is a social animal and we are most contented when following our true nature of mutual caring which includes education, from the Latin Educere “bring out, lead forth”

      A Merry Christmas to you all.

      Ref
      Press release (17 June 2021) Loneliness minister: “It’s more important than ever to take action”
      https://www.gov.uk/government/news/loneliness-minister-its-more-important-than-ever-to-take-action

      Reply

      • There are a few differences to when you were a teenager. One is teenagers have mothers who are on SSRIs and who will often push for their teen to take them also – this means the compliant teens rather than the rebellious may be more likely to end up on meds. Mothers are a potent conduit.

        The teens are also a time for cult like behaviour. There is pressure now to go to the gym, be vegan and take an SSRI from this quarter also. Back in the 1960s we could be saved and then leave the Children of God or the moonies – its harder to leave an SSRI behind.

        D

        Reply

        • Yes, another difference I can think of which is different today if you remember. In a city like London in the 1960’s, it was the era of doctors over proscribing barbiturates – mostly to women. A compliant teen with an addicted mother was at greater risk to seek relief in self medication (substance abuse) due to the resultant intolerable home situation.

          The first Brain Committee Report (chaired by Lord Brain if your wondering about the title) stated that enough of the drug was distributed each year to provide twenty tablets a head for the entire population. The GP’s habit upon seen a TNP (Thick Note Patient is UK medical slang for any patient that visit their doctor frequently) coming through the door was to immediately start writing a repeat prescription to end the consultation quickly, whilst no doubt reasoning “what else can we do?.” I remember seeing multiply brown tubs full of the same drugs in bathroom and kitchen cabinets. This is were many of the 60’s street drugs came from to my knowledge. It was exchange and barter, using whatever pills were available at home, to trade with for one’s drug of choice.

          As a doctor you will know the effect which this class of drug has on some people who may already have some psychiatric or social issues. The features I remember (retain clear mental pictures of) about their detrimental effect on people were extreme moods swings and forgetfulness, but of course there were worse aspects which were kept hidden from outsiders as much as possible by those families. For instance, bringing friends home for them was difficult in case Mom had one of her turns. This was so common that the question ‘why’ was never asked as we knew from what we heard on the grape vine that their Mom was ‘not feeling quite herself at the moment’. Jacqueline Susann’s 1966 novel, Valley of the Dolls (doll is slang for barbiturate) was poplar with us long before the film version hit the screens as it resonated so much with our life in the 1960’s (only we didn’t have swimming pools in our back yards).

          Another danger was that drug pushers are astute observers and manipulators of others emotions and I’ve watched how they can home in on anyone down in spirit – as compliant teens often are from such homes. Finding that a stranger you’ve only just met, is interested in all the things your interested in, doesn’t always ring alarm bells, so in the city one has to be streetwise as to peoples motives before they hook you. I didn’t think of it as pressure at the time but ‘it’ was there all the time – in retrospect.

          As you will know better than most, barbiturates too, are very hard to get off and many addicts had to continue taking them for life if the drugs didn’t destroy them first and the family unit. Therefore, I don’t see those times as having been any safer.

          Reply

  7. The Life of a Teen, as I learnt from my own teen, is expressly private.
    Although as a teen, myself in the 60s, my own life was expressly private from my own parents as, as much as I loved them, much of my life had not a lot in common with the ‘parents’.

    The books I read at the time from Catch-22, The Carpet Baggers, to James Joyce to The L-Shaped Room, some of which I ‘borrowed’ from my brother who was six years older; I devoured these books taking me in to a grown-up world which seemed a million miles away from…

    I introduced my teen to Cormac McCarthy, Annie Proulx, and she introduced me to Twilight.
    Her Canadian father had so many books, we could hardly house them.

    All these diagnosis that today’s kids are given, PTSD, Bipolar, Personality Disorder, etc. spawned by the drug companies and sucked up by the Royal College of Psychiatrists and GPs, etc., should widen their field to contemporary fiction bought in a bookshop near you.

    Samizdat has published great books, who are our nearest and dearest, but doesn’t a history of good reading put us in a place others don’t see, especially when fiercely attacked because we were on an SSRI.

    Veganism is great, let’s not be old-fashioned…

    Reply

  8. “NICE presented with an opportunity to advance the health of all, continued to do as it had previously done – basing its guidelines on dodgy literature, making them essentially a free marketing tool for pharmaceutical companies”.

    “NICE has announced two new proposed QOF (Quality and Outcome Framework) indicators for the 2023/24 QOF, covering physical health checks and anticoagulants.
    The first potential new indicator aims to ‘increase the number of people with severe mental illness that receive the range of physical health checks recommended by NICE’.
    ‘People with severe mental illness are at a greater risk of poor physical health and die on average 15 to 20 years earlier than the general population’, NICE said”.

    “These annual checks help GPs identify and address modifiable risk factors linked to premature death”.

    (Above text from Pulse Today – GP Magazine).

    “There are other significant adverse effects from SGAs (Second Generation Antipsychotics) including drug induced parkinsonism, akathisia, dystonias, significant weight gain, prolactin elevation, hyperlipidemia, hyperglycaemia, onset of type 2 diabetes and more”.
    (Ref. Use of Antipsychotics: Risk of Tardive Dyskinesia. D. N. Osser MD.
    Psychiatric Times. 39. 12. 2022).

    Add on the Increased risk of pneumonia/covid with respiratory dyskinesia and naso-pharyngeal dyskinesia (Antipsychotics and SSRI/SNRI ADS r.), also PSSD. PGAD. Lithium renal/other toxicity and multiple ‘Mood Stabiliser’ -ADRs/teratogenesis risks: No wonder there is premature death, ‘economic inactivity’ and social isolation.

    I find it hard not to consider that NICE are recommending GPs screen annually for life-limiting and life-destroying iatrogenesis? (Perhaps there might be more detail in the NICE proposal not covered in this review)?

    I remain deeply concerned that some, perhaps, many of these people with acknowledged, reduced life expectancy are not suffering from/have never suffered from ‘Severe Mental Illness’ but have had their psychotropic drug induced akathisia, emotional blunting, disinhibition and Rx-induced suicidal ideation misdiagnosed/serially misdiagnosed as S.M.I.

    Isn’t this a missed opportunity for recognising and correcting misdiagnosis, and then managing iatrogenesis by meticulous and individually designed (hyperbolic?) dose reduction and eventual withdrawal, (where possible) of the causative ‘medications’ on a selective, one by one basis?

    How much pressure on a grossly over-stretched N.H.S could be achieved by such genuinely evidence-based and compassionate, patient-centred care?

    Where there has been a relevant diagnosis, surely morbidity and mortality improvement would be achieved by using the minimal dose of psychotropic drugs
    for the minimum time?

    It is emphasised that all psychotropic drug withdrawal should take place under expert medical supervision in view of serious and life-threatening withdrawal syndromes. Perhaps best practice in prescription drug-withdrawal could be addressed during Specialist Training and Vocational Training in General Practice, as well as in continuing professional development.

    Reply

  9. Florida governor seeks grand jury investigation into Covid vaccines
    Ron DeSantis asks state supreme court to investigate undefined ‘wrongdoing’ related to vaccinations
    Ron DeSantis
    Associated Press in Miami
    Tue 13 Dec 2022 22.13 GMT
    The Florida governor, Ron DeSantis, said on Tuesday he will petition the state supreme court to convene a grand jury to investigate “any and all wrongdoing” with respect to Covid-19 vaccines.

    The Republican governor, often mentioned as a possible presidential candidate in 2024, did not say what wrongdoing the panel would investigate, but he suggested it would be in part aimed at jogging loose more information from pharmaceutical companies about the vaccines and potential side effects.

    He made the announcement following a roundtable with the Florida surgeon general, Joseph Ladapo, and a panel of scientists and physicians.
    “We’ll be able to get the data whether they want to give it or not,” DeSantis said. “In Florida, it is illegal to mislead and misrepresent, especially when you are talking about the efficacy of a drug.”

    Vaccine studies funded by pharmaceutical companies that developed Covid vaccines have been published in peer-reviewed journals like the New England Journal of Medicine, and government panels reviewed data on the safety and effectiveness of the shots before approving them for use.

    Statewide grand juries, usually comprising 18 people, can investigate criminal activity and issue indictments but also examine systemic problems in Florida and make recommendations. Recent such panels have tackled immigration issues and school safety.

    DeSantis noted that Florida recently “got $3.2bn through legal action against those responsible for the opioid crisis. So, it’s not like this is something that’s unprecedented.”

    That money came largely through lawsuits and settlements with drug makers, retailers and distributors.

    DeSantis said he expected to get approval from the supreme court for the statewide grand jury to be empaneled, probably in the Tampa Bay area.

    “That will come with legal processes that will be able to get more information and to bring legal accountability to those who committed misconduct,” DeSantis said.

    DeSantis also announced that he was creating an entity called the public health integrity committee, which will include many of the physicians and scientists who participated in the roundtable on Tuesday. The group includes prominent opponents of lockdowns, federal vaccine mandates and child vaccinations.

    He said that over the course of the pandemic some people had lost faith in public health institutions, including the US Centers for Disease Control and Prevention. The governor has frequently spoken out against CDC directives, including mask and vaccine mandates, and filed lawsuits to stop many from taking effect in Florida.

    Additionally, the governor announced that Ladapo would conduct research through the University of Florida to “assess sudden deaths of individuals in good health who received a Covid-19 vaccine
    DeSantis also said the Florida department of health would utilize disease surveillance and vital statistics to assess such deaths.Intended for healthcare professionals

    and an article commissioned by Thebmj
    Why is Florida’s governor ramping up his anti-vaccine rhetoric?
    BMJ 2022; 379 doi: https://doi.org/10.1136/bmj.o3061 (Published 23 December 2022)
    Cite this as: BMJ 2022;379:o3061
    Gavin Yamey
    Author affiliations
    Duke University, Durham, NC, USAOn

    13 December 2022, Florida Governor Ron DeSantis held what he ominously called a “Covid-19 mRNA vaccine accountability roundtable.”1 The event featured his surgeon general, Joseph Ladapo, and Martin Kulldorff and Jay Bhattacharya, authors of the Great Barrington Declaration and now senior scholars at the Brownstone Institute, a libertarian think tank.

    The roundtable was a high visibility opportunity for the governor to escalate his opposition to covid-19 vaccines. As Dylan Scott, health care reporter for Vox noted, the roundtable was part of an intensifying campaign by DeSantis to “discredit the covid-19 vaccines, the drug companies that produced them, and the public health officials and government leaders who urged Americans to get them.”2

    The event did not come out of the blue. DeSantis and Ladapo have previously alarmed the public health community, both in Florida and nationwide, with their sceptical statements about covid-19 vaccines and their suggestion that the public has been misled about the value of vaccination.3 In February 2021, Ladapo called universal covid-19 vaccination “a chimera” and questioned the vaccine’s safety and effectiveness.4 In March 2022, the two men stood side by side as Ladapo proudly announced that Florida would be the first US state not to recommend covid-19 vaccination for children.5

    DeSantis ramped up the rhetoric even further at the roundtable, announcing the formation of a statewide grand jury investigation into alleged “crimes and wrongdoings” related to the vaccines, though he offered few details on what the jury would examine. Asked what he thought DeSantis hopes to accomplish with the investigation, Anthony Fauci, outgoing White House medical adviser, told The Hill: “I don’t have a clue … what he’s asking for. I mean, we have a vaccine that, unequivocally, is highly effective and safe and has saved literally millions of lives.”6

    Benjamin Mazer, assistant professor of pathology at the Johns Hopkins University, pushed back against the Florida governor’s suggestion that the public has been misled. “To believe the covid vaccines have serious hidden safety issues,” he wrote, “is to believe in conspiracy theory. It requires not just distrusting FDA (they’re fallible) but regulatory agencies around the world, all of whom have approved the vaccines and recommended them for the general population. This is to say nothing of the broad peer reviewed literature supporting vaccination, and an almost universal consensus among doctors and scientists. There are specific vaccine policy questions in which there is real debate, but not about their fundamental safety and efficacy.”7

    Why, then, is the Florida governor taking his vaccine scepticism to the next level? It only makes sense as a political ploy. As Albert Lin, cardiac electrophysiologist at North western Medicine, said, the grand jury investigation is “a purely political exercise that is 99% likely to not enlighten public policy over C19 [covid-19] vaccination.”8 DeSantis is widely expected to run for US President in 2024, and pushing vaccine scepticism plays well with the conservative base who he will need to win over if he is to beat Donald Trump to be the Republican presidential nominee.

    DeSantis holds an early lead over Trump in polling among Republican primary voters.9 He could shore up this lead if he can pry away more conservative voters. Pushing a message that government vaccine campaigns—in cahoots with companies—are over reaching is likely to play well with voters who reject “big government.”

    This anti-vaccine message also helps to detract from the Florida governor’s own disastrous performance in averting covid-19 deaths. As Oliver Johnson, mathematician at the University of Bristol, noted, if Florida were a country, its covid-19 death rate (3,874 covid-19 deaths per million) would put it at “10th worst in the world, behind Peru and various East European countries that got slammed pre-vaccine.”10

    As the US heads into winter, and is seeing rising covid-19 hospital admissions and deaths, concentrated in older people, Florida is doing particularly poorly at protecting its most vulnerable citizens from death.11 Booster coverage rates among residents of nursing homes in Florida are the second lowest among all states in the country—which is entirely unsurprising given the stances of the Florida governor and his public health team. It is a great irony that the Florida governor enthusiastically adopted the debunked Great Barrington Declaration, which argued for “focused protection” of older people; a strategy that, without vaccination, has not been proven to work.12

    And there’s another irony. On the day DeSantis held his roundtable, a new study was published by researchers at the University of Maryland, York University, and Yale School of Public Health that estimated that the US. Covid-19 vaccination campaign prevented over 18 million hospital admissions and over three million deaths.13 The study authors also noted that the campaign “saved the U.S. more than $1 trillion in medical costs, and has preserved hospital resources, kept children in school, and allowed for reopening of businesses and other activities.”

    DeSantis could have embraced the study’s findings. But instead of encouraging more Florida residents to get vaccinated, or announcing a strategy to get boosters to older Floridians in nursing homes, he doubled down on his anti-vaccine rhetoric. It’s a political stunt that plays well to the right wing of the party, but leaves many of the most vulnerable people unprotected.
    Footnotes
    Competing interests: GY has received four doses of mRNA vaccination, and believes that Covid-19 vaccines are very safe and effective. He was a member of an unpaid advisory group during the design of COVAX, the global multilateral mechanism that aimed to achieve global vaccine equity. He has received research funding from the Carnegie Foundation for a two-year study aimed at understanding key design features of a future global pandemic vaccine facility.
    commissioned, not peer reviewed.

    He also has connections to Thebmj
    Yamey moved to San Francisco in 2001 to become the deputy editor of the Western Journal of Medicine while also remaining an assistant editor for The BMJ. By 2004, he was appointed as a founding senior editor of PLOS Medicine and was the principal investigator on a grant from the Bill & Melinda Gates Foundation to support the launch of PLOS Neglected Tropical Diseases.[1] A few years later, Yamey received a Kaiser Family Foundation Mini-Fellowship in Global Health Reporting

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