From Gaia Hypothesis to Pandora

June, 13, 2021 | 7 Comments


  1. Blood Red – moving the needle …

    ‘if the jar is full of evils, then what is expectant hope – a blessing – doing among them? 

    ‘Pandora opened a jar left in her care containing sickness, death and many other unspecified evils which were then released into the world.[4] Though she hastened to close the container, only one thing was left behind – usually translated as Hope, though it could also have the pessimistic meaning of “deceptive expectation”.[5]’

    ‘and the huge amount of hurt that companies like Glaxo have already suffered over drug safety controversies might move the needle.’

    Matthew Herper

    But the reality is probably that top executives will frequently be insulated from being directly connected to bad decisions at drug companies. This is partly because many of these decisions are made by lower level executives. The best hope is really that changes in the pharmaceutical industry’s business model, which make mass-market pushing of medicines less appealing, and the huge amount of hurt that companies like Glaxo have already suffered over drug safety controversies might move the needle. The reality is that there may not be a fix – there will always be bad actors – but that both companies themselves and patients and doctors will need to remain vigilant of the risks and benefits of new medicines.

    My Portrait of Sir Andrew Witty, CEO of Glaxo Smith Kline (GSK), as Frankenstein. for Dr David Healy’s post, Brand Fascism, which tells the story how pharmaceutical marketing seems to be perverting, or limiting, the power of medical science, because it places the interests of corporate investors, before the health of their customers.

    Pills of Hope

    Pills you can believe in

    14th illustration –

    moving the needle…

    Where is the smoking bat? 

  2. Just some higgledy pigglydy thoughts – there are now more elderly folks as well as all ages than ever doing star jumps in leisure centres., counting steps rather than enjoying a walk. Many find the communal activity and health benefits enjoyable But do we need a population being made to feel guilty if not as obssessed with health . There is loads of money to be made there but also there is a way of using health as a control over lives .This is no way to spend leisure after a life time controlled by the authoritarian god of work. Although the pandemic has highlighted that many missed the world of work others , the dispensable , now understood to be the indespensable were driven to risk and lose their lives So now much more of the population has become even more fearful of becoming unfit of not heeding health messages and pressured into taking the vaccines and so on. .People who can afford them of all ages now use fitness apps which have a preventative message which will be useful to some extent but again is another controlling feature on individuals’ lives.
    James Lovelock was something of a cult amongs a minority of us who were attuned to his teaching , he is still found on the shelves of dusty specialist bookshops – His message got lost and is now being promoted again by such as Attenborough the darling of climate change who came to it a bit late . In time to scare just enough but not enough to effect those who have the power and leaves the majority feeling helpless Bit Like having a message from the royal family. There is a royal family of the good with as ever leaders of climate change attending fuel guzzling rallies where masses of people applaud them and march behind them, They do give an indication of how much support there is or how divisive a campaign might be but it is difficulat to guage how much change is brought about. It requires a level of optimism to take part.In a way it’s similar to how blogs have spread the message in health care -there is success to be measured by how far the message and growing opposition to the damage being caused has come over the past few decades especially since use of the internet. There is the undesirable side of how individuals rather than the collective become lesser gods and godesses depending how deep a tunnel or high a tree house or how the yacht is paid for..Green Peace and other organisations became big business all campaigning for more and more donations to fund ever expanding organisations and their expenses The warnings expand from more and more experts while forests burn or are cut down by climate enthusiasts who are unable to learn from the people who actually live in places which they love and understand -where they create more harm than good. eg draining peat bogs, cutting down swathes of forests causing landslips and floods or forcing farmers to change practices which have cared for the land for centuries with passed on knowledge and wisdom. In Wales massive diesel stinking machinery is everywhere ‘managing’ the countryside which has managed itself for eons with the help of these people in a Gaia like fashion not understood by the young ‘experts’running their projects today..
    In dealing with climate change we need a collaboration between men and women and young and old just as in medicine. We have never needed doctors to behave like daddy knows best – but now they have reverted to acting like children doing as teacher tells them ignoring the aquired wisdom of lesser ‘experts’ ‘ordinary people’, with some useful wisdom from experience and certainly from what they know of their own bodies, We need medics who don’t just pay lip service to ‘listening’ who can find pleasure in achieving an adult level of maturity in inclusive dialogue. It is interesting though that the majority of the leaders who are public figures regarding the campaigning for the sort of health care described here – are admirable men, while admirable women tend to be behind the scenes. Could it be seen that the men are still taking a traditional masculine protective role while still promoting change – which wouldn’t necessarily be a bad thing.


    The Robber Bridegroom
    This might be the most disturbing Grimm story yet. A man sets out to marry a miller’s daughter.
    A bird whispers to her to leave but she decides to enter the house anyway. After looking she finds an old woman who tells her if she stays then the only thing she’ll marry is her death. She offers to help the girl and hides her. While the girl is hiding, a group of robbers, including her betrothed, come in dragging a girl with them. The girl, crying and pleading, was given wine, then killed and cut up into pieces to be eaten. .
    With a modern twist by the brothers and sisters Grimm at the MHRA

    Covid-19: US regulator raises “significant concerns” over safety of rapid lateral flow tests
    BMJ 2021; 373 doi: (Published 14 June 2021)
    Cite this as: BMJ 2021;373:n1514
    Gareth Iacobucci

    The US Food and Drug Agency (FDA) has raised concerns about the safety and the marketing of rapid lateral flow covid-19 tests, which are the cornerstone of the UK’s mass testing programme.

    On 10 June,1 the agency warned the public to stop using the Innova SARS-CoV-2 antigen rapid qualitative test for detecting infection and suggested the tests should be destroyed and binned or returned to the manufacturer.

    The FDA published a class 1 recall of the test after an investigation carried out between March and April uncovered “significant concerns that the performance of the test has not been adequately established, presenting a risk to health.” Class 1 is the most serious kind of recall and indicates that use of the tests may cause serious injury or death.

    In addition, the FDA said that “labelling distributed with certain configurations of the test includes performance claims that did not accurately reflect the performance estimates observed during clinical studies,” and that the test “has not been authorised, cleared, or approved by the FDA for commercial distribution or use in the US, as required by law.”

    In a warning letter to the manufacturer,2 the agency wrote, “The clinical performance estimates reported in the labelling of the 25T configuration and 7T configuration devices are false or misleading as they do not accurately reflect the performance estimates observed during the clinical studies of your devices.” The FDA also noted that the clinical study data Innova submitted in its emergency use authorisation (EUA) request for the test was “identical to data previously provided by other manufacturers” in separate requests. “The data reliability and accuracy problems noted herein raise significant concerns that the performance of the SARS-CoV-2 antigen rapid qualitative test has not been adequately established, and that the products distributed by Innova without FDA approval, clearance, or authorisation could present a serious risk to the public health.”

    In a statement, Innova said it has “worked diligently and proactively to tackle the FDA findings,” adding that “none of the inspectional observations concern the performance of the test.” The company said, “We have voluntarily recalled the products as a result of labelling that was not consistent with FDA regulatory requirements. We are confident that we are on the pathway to fully comply with FDA requirements.” Innova added, “Since Innova rapid antigen tests have not received EUA in the US, Innova is not shipping these products for commercial use. We intend to seek FDA authorisation to commercialise our rapid antigen test in the US.”

    The FDA’s notice came just days after the Royal Statistical Society (RSS) called for new standards for diagnostic tests in the UK3 in response to regulatory gaps identified during the covid-19 pandemic.

    Following the FDA’s warning, Jon Deeks, professor of biostatistics at University of Birmingham, who co-chaired the RSS’s working group on diagnostic tests, said, “There have been many problems with transparency in the evidence to support the government’s policies for use of this lateral flow test, which negatively impacts on uptake. Given the more serious concerns identified by the FDA, it is essential that full explanations and data are provided to explain decisions made about its continued use, if that is the decision made.”

    The Department of Health and Social Care said it had confidence in lateral flow tests. “The Innova test has already gone through the UK’s rigorous Porton Down assessment process, and we have a robust quality assurance process in place,” said a spokesperson.

    Graeme Tunbridge, Medicines and Healthcare Products Regulatory Agency (MHRA) director of devices, said, “The MHRA are reviewing all available information and are working closely with NHS Test and Trace to ensure that a full risk assessment is undertaken, as is our normal process, to understand any implications for products being used in the UK. Patient safety is our priority and we will publish safety information as and when necessary.”
    I decline taking the vaccine and before going near a relative recently took three tests at intervals of 1 every 2 days thinking this would give a good chance of revealing a negative if infected All negative but I still wore masks and recommended distancing. The tests are promoted and are freely available in UK to citizens who are only now being told the above -so many people have not had the advantage on knowing the MHRA is not reliable in it’s advice regarding the tests.

  4. This is a copy of a letter which can be easily copied by anyone concerned to send to MPs in UK :-

    Medical Freedom Bill
    my stuff

    Save Our Rights
    Mon, Jun 14, 10:18 PM (13 hours ago)

    Dear (name of constituent MP with address or they will ignore/fobb off)

    I’m writing to you today as your constituent and in favour of Save Our Rights UKs Medical Freedom Bill Campaign. This campaign is further supported by Lawyers for Liberty, UK Medical Freedom Alliance, World Freedom Alliance and Workers for England Union.

    This has been an ongoing campaign for many months with two large scale protests in the name of Medical Freedom occurring on both 24th April and 29th May. These have been the largest protests of these types as Medical Freedom is not something people are willing to give up.
    We are seeing many concerning examples of infringements upon our Medical Freedom already. Trials of Covid Status Certifications by private companies, coercing people into having tests or vaccines to enable them to partake in society. Talk of mandating vaccines for certain professions. GP’s refusing to treat people who are medically exempt from wearing masks despite being told that they cannot do so. Hospitals refusing to treat people who are not symptomatic and would choose to not take a test. Calls for the vaccinated to be given freedoms whereas the ones who feel the vaccine is not right for them at this time to have their freedoms restricted. And lastly the Government putting out surveys questioning whether a vaccine requirement for school attendance ought to be brought in.

    As my MP I urge you to consider what this truly means. This is a HUGE infringement upon our rights, in fact your rights too. We are already in dangerous territory and it cannot go any further.

    Parliament’s job is to uphold our Human Rights therefore I believe it is imperative that a Medical Freedom Bill is brought before Parliament as a matter of urgency.

    The Medical Freedom Bill would prevent:

    Mandation of medical procedures

    Introduction of vaccine passports or Covid-19 status certifications by Government, companies, corporations or any other body

    Coercion into consenting to medical procedures by way of withholding services and/or freedoms

    Discrimination against a person based upon their decision to partake in any medical procedure

    All of this is covered in the likes of UNESCOs Universal Declaration on Bioethics and Human Rights 2005 Articles 3 and 6 yet the Government seem to be taking little notice of such international precedent which means that it is necessary to have it written into British legislation.
    Let me know your stance on the matter and how you will protect your constituents Medical Freedom

    I would ask that my behalf oppose any such measures in the House

    I also ask that you write to Boris Johnson on my behalf and request a Medical Freedom Bill as a matter of urgency

    Kind Regards

  5. Baum Hedlund Aristei & Goldman
    15 Jun

    So proud of you and others who helped make a difference on this incredibly important day.

    Kim Witczak

    · 13 Jun

    Going through files and stumbled on this 2004 photo of group of families, lawyers, and @DrDavidHealy. We had meeting with FDA’s Dr.Tom Laughren and Dr. Bob Temple to discuss antidepressants & suicide day after @US_FDA Ad Com. Fun watching Healy & Temple debate facts. Healy won.

    Given that Paxil has been linked to a greater frequency of adverse event reporting for withdrawal reactions than any other psychotropic drug in history, this proposed method of demonstrating efficacy, which current data suggest would be unquestionably effective in the short run, might do FDA and medicine in general a great deal of harm in the longer run.

    There seems to be a wider crisis also, in that arguably there is no greater divide anywhere in therapeutics between the evidence base and its representation than there is between the representations of the adverse effects of SSRIs in pediatric populations in the scientific literature and the evidence from the raw data taken from clinical trials as to what the true frequency of those adverse effects actually was. This makes it difficult for FDA to rely on input from academic clinicians.

    These issues need careful consideration given the very real indicators from the clinical trial database that SSRIs may be effective for some children with nervous disorders. It will take me about 20 minutes to present the material for consideration that I believe would be most constructive for the purposes of your review.

    David Healy MD


    APA at odds with FDA Advisory Panel

    Journalists on Prozac and “black box” warnings

    The ‘running’ picture …

  6. O.M.G. Another Guideline! How NICE
    Shared decision making underpins good healthcare
    Shared decision making between service users and healthcare professionals is an integral part of healthcare, says NICE, in new guideline recommendations published today.
    17 June 2021
    Healthcare worker and patient having a discussion

    The new recommendations advise that shared decision making should be part of everyday practice across all healthcare settings. The guideline sets out ways for healthcare professionals to work with people using services to make decisions about their treatment and care, and to ensure this is best practice at an organisational level.

    Shared decision making is a collaborative process that involves a person and their healthcare professional working together to reach a joint decision about care.

    Prof Gillian Leng, NICE chief executive, said: “We’re delighted to see this shared decision making guideline published and we hope it will help people using healthcare services feel more confident in discussing care and treatment options with their healthcare teams. These recommendations should help healthcare professionals to embed good practice in all their interactions with the people they are caring for and at an organisational level.

    “We view these recommendations as underpinning the implementation of all NICE’s work, and it’s important that these recommendations are put into practice at all levels across the system to support patient care.”

    The new guideline offers advice on how to engage people accessing care in the shared decision-making process through honest conversation and by providing information resources before, during, and after appointments. The use of posters and patient decision aid leaflets are recommended to help the process.

    The guideline suggests that, where possible, organisations should consider appointing a patient director to support the embedding of shared decision making at the most senior levels of the organisation and to help ensure the voice of service users is heard.

    The guideline also includes recommendations on organisational planning, training and healthcare delivery to help organisations improve staff awareness of the importance of patient involvement, and ensure they are willing and able to embed shared decision making in organisational culture and practices.

    Alongside the shared decision making guideline, NICE has collaborated with NHS England and NHS Improvement to develop a standards framework to determine whether the quality of shared decision-making support tools, including patient decision aids, is sufficient. The framework is designed for people who use patient decision aids, whether they are patients or clinicians. It also includes a simple self-assessment tool for people who produce patient decision aids so that they can quality check their processes and products.

    James Sanderson, Director of Personalised Care at NHS England and NHS Improvement, said: “We very much welcome the new shared decision making guidelines and framework published today by NICE, which encourages this very important conversation between clinicians and the people they are supporting, so the patients we look after get the most appropriate and effective care.

    “This is critical in giving people choice and control over their mental and physical health, as we have committed to in the Long Term Plan, ensuring better experiences for people using health services based on partnership, and is particularly important as we recover from the COVID-19 pandemic.”

    In addition to this, as part of a package of resources to accompany the shared decision making guideline, NICE has collaborated with Keele University to develop a learning package, aimed at healthcare professionals, to help with implementing these recommendations.

    Prof Katie Maddock, Head of Keele University’s School of Pharmacy and Bioengineering, said: “The School of Pharmacy and Bioengineering is delighted to have been able to share our expertise in both shared decision making and the delivery of online education with the specialists at NICE to develop this new learning package. This new resource will enable practitioners from all healthcare professions to develop and put into practise the skills required for shared decision making which is a fundamental component of person-centred care. We are very much looking forward to the release of the education package alongside the new NICE guideline and also to evaluating its use within healthcare.”

    Prof Leng added: “We’ve been delighted to collaborate with our partners to develop this guideline, the patient decision aid framework, and the learning package to fully support bringing these recommendations to the healthcare system.”

    The guideline and accompanying tools and resources can be read here.

    A blog by Siân Phipps, lay member of the NICE shared decision making guideline committee, can be read here.

    These recommendations should help healthcare professionals to embed good practice in all their interactions with the people they are caring for and at an organisational level

    Prof Gillian Leng, NICE chief executive
    We very much welcome the new guidelines and framework published today by NICE, which encourages this very important conversation between clinicians and the people they are supporting.

    James Sanderson, Director of Personalised Care at NHS England and NHS Improvement
    This new resource will enable practitioners from all healthcare professions to develop and put into practise the skills required for shared decision making

    Prof Katie Maddock, Head of Keele University’s School of Pharmacy and Bioengineering

  7. There’s Something about Leonie.

    And GOSH, there’s something about Katinka…

    The running Commentary, and the running Comments…


    Hi, this is to do with, specifically to do with Study 329. The BMJ took a year to publish the Restoring Study 329, the reanalysis of Study 329. I was just wondering what you thought of the fact that, would it be a factor that the BMJ clinical editor is married to a partner in Ropes and Gray, the same law-firm that GSK paid to defend them in the US department of justice action?

    Ben Goldacre

    I don’t know – also I don’t care.

    Ben Goldacre

    Yeah, I mean I think it should probably be retracted. BUT, again, what’s the purpose of a retraction, because anybody switched on knows that Study 329 was crap – and, also are we going to retract the tens, possibly hundreds of thousands of clinical trials that also switched their main outcomes?  I mean, maybe we should, but that’s a really big piece of work and why would we, why would we be more interested in Study 329, than the tens or hundreds of thousands of trials which we know switched outcome?  I mean this is a systemic structural problem. I mean Study 329 has rhetorical value for getting the media interested and engaged. But why are we trying to retract that one trial, rather than a hundred thousand trials that also switched outcome?

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