The Eclipse of Health Care

November, 29, 2021 | 13 Comments

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  1. A Golden Oldie…

    GSK’s Transparency and Access Journey

    November, 4, 2013 | 10 Comments

    https://davidhealy.org/gsks-transparency-and-access-journey/

    “At GSK we firmly believe that making more information available, including clinical study reports and anonymised patient-level data, will enable researchers to study the science behind today’s medicines more closely, to learn more about them and how they can best be used.

    For GSK the transparency and access journey [i] started with online clinical trial studies in 2004 and has so far led us to the endorsement of the AllTrials Campaign last year, as well as access to anonymised patient data launched in May 2013. Ultimately this has the potential to improve patient care and drive open innovation.

    When patients volunteer to take part in research they have a legitimate expectation that the data will be used to enhance knowledge and improve patient care. Our actions towards transparency are an essential part of meeting those expectations. By being open and accessible we become an even stronger and more trusted partner for society, patients and health care professionals and at the same time improve patient care.

    We have been open in describing the steps we have taken. Our initiatives has been acknowledged and welcomed by governments, NGO’s and research institutions.

    The recently published report from the Science & Technology Committee in UK, states regarding patient level data: “We recognise the efforts of some members of the pharmaceutical industry, particularly GSK, to increase clinical trial transparency and hope that other companies will act in the same spirit in implementing industry-wide principles for responsible clinical trial data sharing”.[ii]

    Our initiatives have been commended by campaign groups as setting a new standard for greater transparency. In response to our commitment to develop a system for access to patient level data, Ben Goldacre, (author of “Bad Pharma” and co-founder of AllTrials) said: “It is a great initiative; I call for it in the book, I hope it happens at GSK, consistently, and I hope it is copied”.[iii]
     
    Similarly, in response to GSK signing up to AllTrials, where the Cochrane Institute is one of the partners, and committing to post CSRs, Tracy Brown from Sense about Science said: “GSK signing up to the campaign is very important, off course, because they are a large global player in clinical research so they have a lot of potentially useful information to share, but also because they are finding a way to put in place the infrastructure needed to do this. Which makes it realistic for others and sets a new standard”.[iv]

    In a BMJ article published March 2013, CEO Andrew Witty explained our commitment to transparency[v] and our global position is also reflected in the recent submission of our views as part of the consultation process with respect to EMA’s ‘Policy 0070 on publication and access to clinical-trial data’.

    We regret that you find a personal meeting irrelevant and would like to repeat our invitation. In GSK we find dialogue very valuable and ultimately to the benefit of patients, and thus our dialogue should be continued in a face to face meeting either in London or in Copenhagen.’

    The Chalmers-Vaillance editorial justified GSK-style in part by making a case that patient confidentiality was extremely important and that the risks of identification were great. This is a strategy Pharma have deployed from the start of the current Data Access Debate –

    1boringoldman has also covered this ground and the apparent growing links between GSK and AllTrials, and how GSK are using their model of transparency to block access to the data.

    [see roaches…]

    http://1boringoldman.com/index.php/2013/10/29/an-addendum/

    Because there is a mismatch between the CSRs and CRFs, the Study 329 RIATers are at a point where they require the raw data – the CRFs. GSK refuses to hand over the CRFs.

    What would the now 35-year-old or so children who participated in Study 329 think should happen at this point?

  2. What’s ‘UP’ Doc…

    GlaxoSmithKline poaches Pfizer vax leader Dormitzer after hemorrhaging vaccine R&D talent

    by Ben Adams | 

    Nov 30, 2021 9:00am

    https://www.fiercebiotech.com/biotech/glaxosmithkline-poaches-pfizer-vax-leader-phil-dormitzer-after-hemorrhaging-vaccine-r-d

    That name is Phil Dormitzer, M.D., Ph.D., who joins the British company as its new global head of vaccine R&D and was previously vice president and chief scientific officer for RNA and viral vaccines at rival Pfizer.

    In that role, he worked on Pfizer and BioNTech’s now world-famous COVID vaccine Comirnaty as well as on Pfizer’s experimental RSV vaccine and its early RNA work on influenza (which was also being done alongside BioNTech).

    Pfizer refuses to share vaccine knowledge as it announces $US36 billion in vaccine revenue

    By Patricia Ranald|November 30, 2021

    https://www.michaelwest.com.au/pfizer-refuses-to-share-vaccine-knowledge-as-it-announces-us36-billion-in-vaccine-revenue/

    Australian Fair Trade and Investment Network (AFTINET), Amnesty International Australia, Médecins Sans Frontières (MSF) Australia, Oxfam Australia, the Public Health Association of Australia (PHAA) and others rallied outside Pfizer offices in Sydney on November 22 to tell Pfizer to stop profiteering from the pandemic, to stop lobbying against the WTO waiver and to share its vaccine knowledge.

    @samizdathealth
    @DrDavidHealy

    19 of 29 “authors” on Pfizer-BioNTech’s key vaccine study are employees; few are clinicians. ICON, a private CRO, ran the study and wrote the @NEJM article. Our tools for evaluating the product are broken.
    Given this reality, “mandates” are madness.
    https://rxisk.org/there-was-a-young-woman-who-swallowed-a-lie/

    ICON has provided clinical trial services to Pfizer over the past 30 years and formed a strategic relationship with the company 

    https://www.iconplc.com/news-events/press-releases/icon-pfizer-biontech/

    Sir Patrick Vallance is the Chief Scientific Adviser in the United Kingdom. Vallance worked for GSK between 2006 and 2018. By the time he left GSK, he was a member of the board and the corporate executive team. The fines and so on which I have listed took place while Vallance was working as a senior figure at GSK. The last time I looked Vallance still held a big chunk of shares in GSK.

    https://www.vernoncoleman.com/malariavaccine.htm

    ICON s…

    • ‘But I sense a growing number of doubters,

      https://hitchensblog.mailonsunday.co.uk/2021/12/peter-hitchens-posing-in-one-of-our-few-tanks-liz-truss-is-not-the-same-as-being-an-iron-lady.html

      Our moronic response to the Omicron threat 

      I wonder why hardly anyone has pointed out that the anagram of ‘Omicron’ is ‘Moronic’. It is quite easy to work out, and I suspect that the reason is the sort of hushed reverence everyone has now for everything to do with Covid.

      Any sort of mockery or criticism of the authoritarian state we are building on the basis of virus-fighting is now treated as a wicked heresy. Voice such doubts and you will be falsely accused, at top volume, of desiring the deaths of the vulnerable and of wanting to let the virus rip, or of being a crazed ‘anti-vaxxer’. But there is something idiotic, if not actually moronic, about the response of this country to the new variant. We simply do not know enough to justify this level of alarm.

      As even the pro-panic semi-official newspaper The Times explained on Friday:
      ‘There is so little data that everything is informed conjecture – back of the envelope calculations with uncertainties so large that the same figures can be used to give succour or presage doom.’

      You should know that when The Times says ‘informed conjecture’, it is trying to avoid saying ‘guesswork’.

      We have already seen, as I predicted long ago, the ghastly long-term damage done to such things as cancer treatment by the subjection of the whole state machine to Covid priorities.

      I mourn for the businesses, small and large, struggling to stay above water through repeated restrictions, and for the children and students whose education has been ripped apart by the same thing.

      Not to mention the sinking of this country and Europe into unbelievable and increasingly permanent restrictions on our personal freedom.

      I must ask again, have we really got this in proportion? I know many people were, to begin with, completely overcome by the fear of the unknown. But I sense a growing number of doubters, no longer persuaded that the measures work or that they are worth it. Or both.

      Make your voices heard, reasonably and patiently, please. It may not save Christmas but it might save Easter.

      ‘Wall of secrecy’ in Pfizer contracts as company accused of profiteering

      US company faces scrutiny over Covid profits after UK agrees to secrecy clause

      https://www.theguardian.com/uk-news/2021/dec/05/wall-of-secrecy-in-pfizer-contracts-as-company-accused-of-profiteering

      The revelation comes as Pfizer is accused by a former senior US health official of “war profiteering’’ during the pandemic. In a Channel 4 Dispatches investigation to be broadcast this week, Tom Frieden, who was director of the US Centers for Disease Control and Prevention under Barack Obama, said: “If you’re just focusing on maximising your profits and you’re a vaccine manufacturer … you are war profiteering.”

      Vaccine Wars: The Truth About Pfizer is on Channel 4 at 7.30pm on Friday

  3. Recently I saw a reply from the GMC addressing concerns raised by an appearance on GMB, by Dr Ellie. The GMC vigoursly defended her position on anti-depressants. Seemingly referring to current NHS guidelines to reinforce their stance.
    This week Dr Alex George, an Ambassador for young people’s MH, appointed by the UK Govt took to Twitter to promote destigmatising psychotropic ‘medication’. Under the hashtag ‘Post your Pills’ He posted a picture of himself holding an anti-anxiety pill. His post had 275,000 likes and literally thousands of others posted images showing how proud they were of their pill taking. Dr Alex was then quoted by the UK’s top MH Charity MIND. There were hundreds of images on Minds website too.
    The narrative in the main was these pills keep me well, functioning, they save lives!. The analogy of Insulin and diabetes was being used extensively though no mention of a chemical imbalence. More like if I don’t have these Meds I will get unwell, I will be ill.
    No where (In the main these posts were by people under 35) was there any mention of serious side effects, the risk of dependence, the risk in pregnancy or the dangers of tapering/withdrawal.
    The hashtag should have been ‘Pop a pill for life’ Because that was what seemed to be being advocated.
    Quote I take Sertraline, and am unlikely to ever come off it. It makes me function and have capacity to be a functioning member of society. The stigma has to end.
    Malin Anderson (Another former Love Island contestant) posts a picture of herself promoting a pill.. revealing she had been suffering pre-natal depression.
    Dr Alex’s words :’I really feel we are starting a movement here. Medication Stigma has gone on for far too long. You have the right to control and look after your health.’
    Dr Alex has 2 million followers…
    With Vaccines being mandated, what next those with depression, anxiety, being mandated to take their Meds in order to function as workers, parents, members of society…

  4. George hardly represents ‘young’ people He looks well into middle age…and talks like a dinasour spouting what he is told to say by his bosses. What people will do for a job eh

    Ellie was on a news prog stating several times that she was not an expert on the subject she was asked to contribute to. Obviously been told to be more careful either by the GMC or her agent. But an action being taken to defend Ellie has been quite successful it seems
    Have had no reply myself to the formal concern forwarded to them weeks ago.
    Sent them a reminder today and asked who is on the decision making panel. Not that there will be any objective investigation of course.

  5. recovery&renewal
    @recover2renew
    ·
    36m

    Oh yeah The meaning of #safe and effective seems hopelessly corrupted.

    Allen Frances
    @AllenFrancesMD

    9h

    I hate Pharma as much as anyone- but there’s no doubt #COVID19 vaccines are miraculously safe & effective. Refusing vaccines now is both foolishly self destructive & selfishly spreads virus to the vulnerable. twitter.com/RxISK/status/1…

    RxISK
    @RxISK

    Oct 18

    Not all vaccine-hesitancy is based on politics, or tall tales on Facebook. Patients who’ve already suffered harm from taking approved Rx drugs “as prescribed” find it hard to believe PhRMA promises: https://rxisk.org/prescribed-harms-and-vaccine-hesitancy/

    What’s going on Here?

    https://davidhealy.org/whats-going-on-here/

    “Your job is to change this so both those not getting care and those not getting justice get a better deal”

    ‘Miraculously’ safe and effective is somewhat close to ‘Remarkably’ safe and effective, as in the GSK Paroxetine Patter…

    https://www.bmj.com/bmj/section-pdf/905402?path=/bmj/351/8025/Feature.full.pdf

    after a marketing campaign that characterised Study 329 as demonstrating “REMARKABLE Efficacy and Safety.” …

  6. Re comment above dec 5th.
    The response from the GMC has been received 2 days later – . I doubt if anyone expected a ‘striking off’ decison .but at least she has been scrutinised once again and likely to have been ‘advised’ off the record.
    GMC – E2-5273BC
    Inbox

    FPD Decisions
    Attachments
    3:27 PM (2 hours ago)
    to me

    7 December 2021

    Thank you for your complaint form of 5 November 2021.

    We have carefully considered the information you provided, and while we appreciate your reasons for writing to us, we don’t feel that these are issues that would warrant further GMC action being taken. We are sorry if this is not the outcome that you were hoping for.

    Our Role
    Our role is directly related to the registration of doctors. Our responsibilities are all connected to keeping the Medical Register. We oversee medical education; we give entry to the Register for those suitably qualified; we advise on good medical practice while registered; and we remove or restrict registration in response to fitness to practise concerns where there may be a risk to patient safety.

    An investigation can only be opened if the concerns raised are so serious that the doctor’s fitness to practise medicine is called into question to such an extent that action may be required to stop or restrict the way in which they can work to protect future patient safety.
    The purpose of an investigation is to determine if or to what extent we need to restrict the doctor from working. We are not a general complaints body and we have no legal powers to intervene in or resolve matters for patients.

    Our decision
    We have been unable to identify any issues that would cause the GMC to launch a full investigation of Dr Cannon’s overall fitness to practise as a doctor.
    In reaching this decision we have also taken into account comments a senior, medically qualified member of the GMC staff has made in respect of the information about anti-depressants, as conveyed by Dr Cannon during the ITV ‘This Morning’ television programme.
    The Daily Mail article essentially reiterates points Dr Cannon had made about anti-depressants during the ‘This Morning’ programme.
    The TV excerpt in question was not a documentary dedicated to establishing the relative pros and cons of anti-depressants. Rather, it was a six-minute piece within a daily ‘magazine-type’ programme that appeared to be designed to provide some ‘general’ information about anti-depressants, and possibly de-stigmatise the use of this medication.
    The piece included reference to Dr Cannon’s personal experience of taking anti-depressants.

    Dr Cannon mentioned that treatment options (other than anti-depressants) were also available. Most importantly, Dr Cannon advised viewers to speak to their own doctor/GP should they want more information about:

    Whether they might be a suitable candidate for taking anti-depressants

    The side-effects of taking anti-depressants

    Steps patients should take when seeking to come-off anti-depressants

    Overall, it would be for a patient’s own doctor/GP to provide advice that was pertinent to the individual patient’s symptoms and circumstances.

    We note you have raised your concerns with the programme-makers and with Dr Cannon’s GP surgery (the latter via a local Councillor and the Patient Advice and Liaison Service (PALS) affiliated with a London-based Clinical Commissioning Group) and we consider this to be an appropriate course of action to take under these circumstances.

    Reviewing Our Decision
    We have an internal review mechanism (‘Rule 12’) which lets us look at certain decisions again. Attached is an FAQ document which explains more about the process
    We will only ever review a case if there is a serious mistake with the decision which, if corrected, could lead to a different outcome. Or if there is significant new information that we haven’t seen before, which might have led to a different decision. We would then only review if at least one of those grounds was met and a review is necessary to protect the wider public. Any review needs to start within two years of the original decision, unless there are exceptional circumstances.
    To request a review, please complete the attached questionnaire and return either via post or email, using the address provided on the form.

    We can only take action when we believe a doctor is not fit to practise and we do not consider this to be the case. We are sorry that we are unable to assist you any further with these matters.

    Yours sincerely

    The Enquiries Team
    On behalf of the Assistant Registrar
    The General Medical Council
    3 Hardman Street, Manchester, M3 3AW

  7. ‘Exotic beliefs’ …

    Hardcore vaccine refuseniks could need deradicalising like terrorists – expert

    A “deradicalisation” programme like those given to former terrorists or cult members might be the only way to dissuade some hardcore antivaxxers from their beliefs, according to one psychology expert.

    https://www.standard.co.uk/news/uk/people-university-of-bristol-hillary-clinton-facebook-newcastle-b970587.html

    Around six million eligible people in the UK have not received a single jab a year on from the first Covid vaccination being given in the UK.

    Professor Stephan Lewandowsky, chair in cognitive psychology at the University of Bristol, was keen to stress that many of those are likely to be “marginalised” people who are “very difficult to reach for anything”, and for whom access is likely to be the biggest issue rather than psychological or ideological factors.

    But for a small section of “hardcore refuseniks”, he said, it may be difficult to reach them by conventional means because their beliefs are so ingrained.

    He told the PA news agency: “They’ll refuse anything – ‘I’m not going to wear a mask’, ‘I’m not going to get vaccinated’, ‘I don’t think climate change is happening’, ‘Covid is a hoax’, and, you know, ‘Hillary Clinton is actually a reptilian shapeshifter’.

    “You’re getting to people who hold a cluster of very exotic beliefs – now, they’re very difficult to reach.”

    Measures that could be used to reach more moderate people who remain unvaccinated, he said, include assigning vaccine appointments to people rather than asking them to book their own, or setting up pop-up clinics in places like supermarkets or shopping centres.

    Another measure would be introducing a vaccine mandate, which he said “will disgruntle a few people” but “can be effective”.

    But for those with more extreme views, he said, those methods may not be effective.

    He added: “In the ideal world, time and money permitting, you can engage even those people in a very slow, long-term process where you affirm their right to have those beliefs… rather than telling them something about themselves they don’t want to hear, let’s put it that way.

    “So you tell them something positive, and then engage in what is effectively the same as a deradicalisation process for former terrorists, or cult members.

    “Because we’re really talking, when we get down to that small number of committed refusers, we’re talking about the psychology of cults and extremism, and it’s a very similar psychology.”

    Mr Lewandowsky said online misinformation is a contributing factor, adding that while some steps had been taken to remove false claims, sites like Facebook and YouTube are “not doing enough”.

    “One of the reasons these hardcore refuseniks exist is because they can live in their own ecosystem of misinformation,” he said.

    Among those who continue to refuse the Covid vaccines is 44-year-old Paul Barrett from Newcastle who believes they are “dangerous”.

    Mr Barrett said he has researched the topic by watching videos and reading articles online and believes the public is “being lied to”.

    “Nothing could make me decide to have this jab, it’s dangerous,” he told PA.

    “I’ve had Covid and it’s true I was very ill and could barely breathe for over a week but I survived through my immune system, I’m willing to continue to trust said immune system rather than a jab with so many cases of bad, life-ending side affects.

    “I believe we’re being lied to.”

    Online Covid misinformation is “a very serious public health issue”, according to one expert.

    Imran Ahmed, chief executive of the Centre for Countering Digital Hate, told PA: “People have died, and more still are at greater risk of suffering from Covid, because they got their medical information from Facebook and other social media sites.

    “These platforms are chronically polluted because anti-vaxxers have been allowed to dump toxic misinformation into people’s feeds on a daily basis for years with impunity.

    “Most people who haven’t been jabbed aren’t what you might refer to as ‘committed anti-vaxxers’ – they are merely vaccine-hesitant, because they’ve been deliberately and cynically targeted with a steady campaign of half-truths, baseless conspiracy theories and outright lies.”

    • Many people who decline being vaccinated research information especially from thebmj which has been updating readers all through the pandemic. Does 44 year old Barrett read it?

  8. – there seems to be a lot of troubled personalities like Amrin and Stephan who are jumping on a bandwagon , ramping up hate against people they don’t like or who don’t share their views. Pots calling the kettles black – They are behaving like sad rather weird people who sit in their bedrooms dreaming up hate campaigns . Using words lile ‘pollution’ toxic’ ‘terrorists’ against those they diagree with isn’t exactly sophisticated Communications like this from a psychologist is a bit dodgy- shouldn’t Stephan and Amrin be forced to enter a re education programme – not run by Bristol uni though if this is what students are being subjected to.

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