This post follows on from The Fog of a Special Medical Operation.
Joe Biden says we have to resist Putin’s Special Military Operation. If we don’t resist this SMO, we are told, Putin will use it as a precedent to extend his reach beyond Ukraine. I don’t know enough about all this, but, perhaps just manipulated by propaganda, while figuring the War is crazy and there must be Win-Win ways to sort things out, I support the right of (all) Ukrainians to resist.
Joe Biden also has a Special Medical/Military Operation (SMMO), of which the vaccine offensive is the most serious escalation so far. [Unlike Putin (probably), Biden seems likely to be something of a glove puppet in his operation].
This SMMO is something I know a lot more about. Pretty well everyone reading this post can likely see significant changes in healthcare happening around them, rather than just coming their way through the media. The changes you see contrast with the propaganda we are all fed, and point to an SMMO. Unless we resist, this escalation is unlikely to be the last. The US Military Industrial Complex, that Eisenhower warned about in 1960, will be emboldened to take further steps we may not like.
We are facing a relentless advance toward technocracy. Like Putin, Biden thinks he is setting out to help ‘brothers’. Unlike the Ukrainians and Putin, most of Us (in the West) have welcomed Biden’s advances. Putin must envy Joe having it so easy – people laying flowers in the path of his advancing troops.
Military Medicine
Shipwreck of the Singular covers the relatively recent emergence of modern medicine. The defense establishments have been the greatest driver behind this development. In War, armies who lost the fewest troops from disease won. It became clear that to win wars you needed surgery and public health. The first war in which more were lost to combat than disease was the 1904 War in which, availing of medical advances resulting from the American Civil War, the Japanese beat the Russians.
Even modern public health was a military thing – starting with the French wanting to make sure they weren’t outnumbered by the Germans.
The role of the military may not come out as clearly in Shipwreck as it does in The Decapitation of Care, above, because in an effort to contain Shipwreck to a reasonable word limit, I scrapped developments linked to the Korean, Vietnam and other wars leaving the Civil War, and the World Wars to illustrate the point.
For more on this and how the Great War made Freud’s name for instance – see Shipwreck in Maastricht and Shipwreck in Bangor.
The developments that came from War are largely good things but there is another side to the interface between War and Medicine.
Over the last thirty years the US Medical Industrial Complex has steadily encroached on areas once considered sacred to most people working in health. And we have been ever less likely to resist as they have done so.
As outlined in a Letter to Joe Biden on October 4 2021, the medico-military complex now support:
- Sequestering access to clinical trial data on medicines or vaccines.
- Ghostwriting of close to all the medical literature reporting trial results for on-patent drugs and vaccines.
- Turning a blind eye to the negative clinical trials of these treatments that are reported as positive.
- Air-brushing the harms of treatment out of existence – creating a new science to do this Harmatology.
- Tolerating the withholding of trial data from Regulators (FDA, Health Canada, EMA).
- Turning a blind eye to the approval of treatments as working even when more people die on active treatment than on placebo.
- Turning a blind eye to regulators approving medicines on the basis of negative studies and agreeing with companies not to let the wider world know about this.
- Accepting that even for drugs for which there are more deaths on active treatment than on placebo, it is acceptable not to warn about these hazards for fear of deterring people from seeking a commercial benefit to companies.
- Silencing of any clinicians who endorse a link between a vaccine and harm or even mention harms.
Where is the medico-military complex in all this? Well Brook Jackson’s False Claims Act against Pfizer has revealed that it is the US Department of Defense who contracted to get the vaccine and are prepared to tolerate it seems pretty well anything to get their product into us – Military Maneuvers in the Dark.
Public Health
In terms of public health, the approach taken now began with John Graunt’s Bills of Mortality in the 1660s. Prior to Graunt people took responsibility for events that happened. Graunt introduced another truth – that events like deaths in workplaces happened with a statistical regularity. For some this introduced the idea they were going to happen anyway and no one was therefore responsible.
So people injured while working in the new industrial enterprises then opening up for the most part ended up thrown on the scrap heap – looked after by religious orders in the hostels (later called hospitals) for the medically indigent (unable to work).
There was a slow recognition that employers might be responsible for accidents that happened in factory settings like slipping on a banana skin the employer had dropped. This came to a head in a series of deaths in mine disasters in the North of France around 1900, which because these were predictable were viewed in old style thinking as Murder but by others as grounds for health insurance and workers compensation.
The American military led the way on this in setting up services for veterans after the Civil War. For many doctors in America, however, this was later viewed as a problem and any efforts to extend it to the rest of the population were branded as socialized medicine. It was incompatible with the relationship between a doctor and patient needed for good medical care.
So, changing one word from the original, we might say
The web of our history is of a mingled yarn, good and ill together: our virtues would be proud, if our faults whipped them not; and our crimes would despair, if they were not cherished by our virtues.
Decapitation of Care
Military medicine learnt to look after the troops, provided they behaved themselves. Discipline is a central military virtue. An army only functions if people obey orders.
When dealing with the wider world, one way to solve the discipline problem is to replace people with machines. Machines don’t disobey.
After World War II it was clear that Tech would be the way forward. The military had a new need to contract with industry for planes, battleships, submarines, munitions (bombs) etc. Businesses like Boeing had the factories and the skilled workers to provide the goods. Some in the military, however, saw skilled workers as a possible fifth column. They could go on strike. They could tell the bosses they were making mistakes.
Telling the boss he was making a mistake was particularly the case when officers coming home from the War were put through MBA programs and moved into management jobs in the companies the military were working with. These managers who drew up the flowcharts for how the operation – building a missile – would be carried out often figured they knew more than the skilled workers.
The entrepreneurs who had set up the factories, in contrast, knew well that their skilled staff knew more than them – just as the priests and nuns who set up hospitals never figured they knew more medicine than the doctors or nurses they employed.
In manufacturing industries, the new management pushed for increased automation replacing skilled machine operators with machines tended by unskilled staff. The number of people employed in manufacturing plummeted. See Religion, Technology and Management.
Many went into service industries like the Fast Food industry then just starting up. Others went into healthcare which looked like a place where skilled staff would always be needed. A wonderful book – The Next Shift – outlines the fall of manufacturing industry and the switch of staff to the emerging health services in rust belt America.
In healthcare new technologies were appearing. Starting in the 1950s there was a steady increase in technologies for measuring blood pressure or blood sugars initially to sophisticated scanners and now mood and other behavioural Apps. (See Brain Health for what may be a particularly naive and dangerous application of these Apps).
These technologies have slowly transformed healthcare into health services. A skilled diagnostician has been steadily been replaced by someone who oversees the machine and acts on the basis of a print-out.
Someone skilled in taking on the problems we bring them has been replaced by a system that gives us problems we didn’t know we had.
Through the Randomizer
Key to this transformation is the elimination of judgement – both the judgements of doctors and of us who go to them. This was brought about by a parasitization of randomized controlled trials (RCT).
As originally envisaged RCTs hinged on clinical judgements – randomization was just a technique for fair allocation.
Instead randomization has been elevated to an almost mystical entity that delivers objectivity. Objectivity no longer comes from doctors consulting with us or grappling with issues among themselves – in the way juries do – as outlined in The Fault Lies in our Stars and Fawlty Stars.
In 1962, after thalidomide, in an effort to contribute to drug safety, companies were required to demonstrate their drugs worked, which a few thought could now be done by using a new but poorly understood technique – RCTs.
Companies initially protested but soon went quiet when they realised that RCTs could be transformed into Randomized Controlled Assays (RCAs).
What’s an Assay. It’s a test that comes with a standard. If this dipstick turns red you have an acid and if it turns blue you have an alkali. If there is this amount of these fats in this brown material you have chocolate and if not you have Cadbury’s which the European Union said could not be called chocolate.
Rather than a way to evaluate a drug, RCAs transform exercises that look like science into simple systems in which all that is required is to hit a target – such as a lowering of depression rating scale scores slightly more than placebo does in order to be called an antidepressant, or producing antibodies in order to be called a vaccine.
With a box to tick, the bureaucrats in FDA or EMA will license this as an antidepressant or that as a vaccine even if there are more lives lost and more hospitalizations on treatment than placebo, and in the absence of any evidence that function has been restored. The same holds true for lipid lowering, blood sugar lowering, bone thickening and all other drugs.
See The evidence that counts for FDA and in The evidence that counts for Us.
The Eclipse of Judgement
In the modern world, numbers trump judgement. When our weight on a weighing scale, or blood pressure figures, or a country’s rate of inflation deviates from a norm, there is an imperative to restore normality. We feel happiest when normal or when our doctor (or leader) is happy our measurements are normal – even to the point of him being will to give and us being willing individually to take a ‘poison’, or collectively to swallow austerity, to get us there.
This triumph of numbers over judgement underpins economic and medical neoliberalism. Our experience of health services today offers us an up close and personal look at the dynamics of economic neoliberalism – The Deep Neoliberal State and Neo-Medicalism.
Neo-medicalism adds a chilling note to Pfizer’s Science Will Win. This Pfizer mantra gives the game away. Science is a journey into uncertainty. Follow the Science mantras offer us the comforts of certainty – that our vaccine or SSRI has been shown to work, claims supposedly endorsed by the super-scientists in FDA. The reality is that our new sacrament has been certified by some bureaucrats as meeting some artificial criteria and we have no idea if it works, or is safe. But we, the faithful, the people who want a father figure to protect us, swallow it.
In the 1960s, doctors recognized the adverse effects of new drugs within months of them being on the market, often simply by accepting what we who were on the drugs told them was happening. This began changing as RCAs, which are the best possible way to hide adverse effects, took hold. The mantra that the RCTs (RCAs) had not shown this could happen steadily anesthetized doctors and flummoxed us and it now takes decades for adverse effects to be accepted.
The SSRIs brought with them the idea that any discussion of the adverse effects of drugs was misinformation and the authorities had a duty to clamp down on it. In 2000, I mentioned in a lecture in Toronto that SSRIs might have side effects and we needed access to Trial (Assay) data in order to be able to assess and work out how to best manage this. The Dean of Medicine claimed this was like someone crying Fire in a Crowded Theatre and it should not be allowed. I was right but I lost my job – Burn Baby Burn.
In 1968 with the crushing of the Prague Spring, Eastern Europe seemed in the grip of a grim totalitarian system. There were assasinations in the United States and riots in Chicago and Paris but, aside from a few people like Norman Mailer who said America was as totalitarian as the USSR, most of us contrasted Eastern darkness with Western light and freedom.
By the 1970s Eastern Europeans like Vaclav Havel were keenly aware of the constraints on their abilities to live the lives they wanted to live – but they did not want to ‘join’ the West. They saw Westerners as just as unfree as they were. We have an advantage they said – we can see the enemy but you can’t.
While Easterners were becoming ever more keenly aware of the constraints on them, Westerners became less aware of the surveillance state taking over their lives, capabilities dramatically enhanced by DARPA’s creation of the internet.
Censorship
There are Bills currently before Californian and Australian legislatures aimed at stopping doctors from spreading misinformation about medical conditions or treatments. Many doctors are protesting that patients need their doctors to have the freedom to recognize problems and review with them their best options.
The scenario envisaged by those concerned about the developing censorship sees the good doctor as like the Catholic priest Grahame Greene wrote about in the The Power and the Glory scuttling around from safe house to safe house, very aware of his limitations but spurred on by the Mission.
This will come as a surprise to many who write for or comment on RxISK posts, where the central theme is that we take our problems or our children’s problems to doctors, who do not believe us, who laugh at us, but we often to our regret end up doing what our doctor says because we have a residual sense they have our interests at heart.
We are at a point where the question of whether Drug A has caused Problem B has for many been replaced as the central question by Why Do You Not Believe Me?
Perhaps when these bills pass we will be able to see the enemy more clearly. See the soft power and propaganda that we are up against. We may be enabled to look after ourselves better as a result – see our reliance on doctors as a central part of the problem. Without a faithful relationship, Care is not possible.
The military approach to adverse events was brought out very clearly in a recent post If You Wake at Midnight and by posts on RxISK Sanctuary Trauma, the Invisible Doctor, and way back in If I Find You Ten Just Doctors.
With vaccines we have the apogee of a military medicine. Vaccine mandates are like orders given to troops – they must be obeyed. They have copperfastened body-snatching of doctors and us – see Strangers in the Room.
Dance to the Music of Time
There is a certain poetry to all this. Around the time when French mines were collapsing killing miners, a century or more before we began tolerating the death of minors from Covid vaccines or SSRIs, the words immunity and self-defense began to change meaning.
They had been solely legal terms for two millenia. But now when we hear immunity or self-defense systems we are more likely to think in medical terms and in our individual selves rather than communities.
This too has reached something of an apogee with the vaccines.
The worry, though, is that our propaganda techniques are even better than our medical techniques in that the mRNA vaccines don’t seem to do anything useful. Besides leading to many premature deaths, their main consequence seems likely to be an evisceration of Health Care.
Just before the Berlin Wall came down, Helmut Schmidt, then a former German Chancellor, referred to the USSR as Upper Volta with missiles – it had lots of military technologies but was economically and socially backward.
In terms of Healthcare, has the West now become Upper Volta with Vaccines?
After the Berlin Wall came down, Vaclav Havel became the president of the Czech Republic. In 2010, just before he died, he said that he and other Czechs were less free than they had been in the 1980s.
It is not clear that technocracy can be fought with more technologies. Fight may not the right word. We are facing something more like a matter of personal responsibilities.
So, changing one word from Havel’s 1978 original in The Power of the Powerless:
A Specter is haunting Health… the Specter of Dissent. You do not become a ‘dissident’ just because you decide one day to take up this most unusual career. You are thrown into it by your personal sense of responsibility… You are cast out of the existing structures and placed in a position of conflict with them. It begins as an attempt to do your work well and ends with being branded an enemy of society. …
The dissident is not seeking power.He has no desire for office and does not gather votes. He does not attempt to charm the public. He offers nothing and promises nothing. He can offer, if anything, only his own skin— He offers it solely because he has no other way of affirming the truth he stands for.
[Applied to Health, she would be more appropriate than he]
Footnote
With the pandemic, Blogs have been replaced by Substacks, which often note a subscription would help keep things going.
Published by Samizdat, Shipwreck of the Singular. Healthcare’s Castaways rolled out with the Vaccines. Its descriptions of a dystopian medical future seem all too present now.
It is priced at $18.95, and $8.99 in kindle from each of which Samizdat gets $5, and even less as El Naufragio de lo Singular.
Samizdat aims at the middle ground in health, enabling conversations to happen. A copy of any of its books for you or a friend, in lieu of an hypnotic, might help us all find a way to wake up.
Shots and Shelling –
The hour-long story of Bhopal, was unmissable.
Even if you don’t take an interest in this Indian Disaster, the final words played has chilling comparisons –
“Who we choose to believe comes down to our own perceptions, people wanted to believe that Union Carbide’s chemical plant was going to make life better, it didn’t – maybe next time we will listen better”
Bhopal
The story of the journalist Rajkumar Keswani, who foretold the world’s worst industrial accident in the Indian city of Bhopal in 1984. Unfortunately, nobody believed him.
The last few minutes – 8
https://www.bbc.co.uk/programmes/m001bs1r
Keswani was the first journalist to bring attention to the safety lapses and impending Bhopal disaster that eventually came to pass at the town’s Union Carbide pesticides plant overnight on 2–3 December 1984. Keswani had written several articles, from 1982 through 1984, detailing that safety standards at the plant were inadequate and that a catastrophic leak could result.
Life after the disaster
After the disaster, Keswani was interviewed on radio and television shows, as he was the only journalist who knew anything about the Union Carbide Bhopal plant. He was called a “Cassandra” and a “lone voice in the wilderness.”[8] Keswani became the youngest person ever to receive the Indian B.D. Goenka Award for Excellence in Journalism in 1985. In his acceptance speech Keswani noted that he might be the first to receive the award for such a spectacular journalistic failure “had he succeed at his task no one would have ever taken note.”[9] Keswani received the “Madhav Rao Sapre Puraskar” award in 2008.[10] He received the Prem Bhatia Award 2010 for Outstanding Environmental Reporting.[11]
Death
Keswani died from complications from COVID-19 on 21st May 2021.[12]
Shockingly ironic…
So what are we expecting?
That some journalist will write a Headline In the Main-Stream :
‘Covid Jags are Causing Millions of Injuries and Deaths – Wake up People!
‘SSRI’s Kill and Main – Wake up People!
Pfizer faces backlash for creating pro-vaccine Marvel comic: Experts say PR tactic is ‘ethically dubious in the extreme’
Professor Martin Marshall, chairman of the Royal College of GPs, said: ‘Existing evidence shows that antidepressants can be an effective treatment for the distressing and often-debilitating symptoms of anxiety and depression when used appropriately.
‘GPs are highly trained to have open and sensitive conversations with their patients, and when discussing mental health concerns they will consider various treatment options based on the unique needs of the patient, and if prescribing antidepressants, it will generally be at the lowest dose and for the shortest amount of time.”
Brook Jackson
@IamBrookJackson
5h
Did FDA run to Pfizer or go directly to Ventavia to get me out of the way?
Brook Jackson
@IamBrookJackson
13h
Replying to @FLSurgeonGen
Two years ago, I filed a lawsuit against Pfizer for fraud in their trials. The cardiac signals were there & much more, but hidden. I am now bringing participants forward w/sworn testimony & across multiple sites that were included in efficacy analysis of the bogus EUA.
U.S. FDA
@US_FDA
Oct 7
“And that’s part of our world.”
Dan Rather
@DanRather
Oct 7
Please get your COVID booster.
Robert F. Kennedy Jr
@RobertKennedyJr
Oct 9
Judicial Watch obtained 249 pages of records from the U.S. Department of Health and Human Services detailing the extensive media plans for a propaganda campaign to push the COVID-19 vaccine.
ROBERT F. KENNEDY, JR. EXPOSES FAUCI, PHARMA AND THE THREAT TO DEMOCRACY WITH NEW FILM
https://www.prnewswire.com/news-releases/robert-f-kennedy-jr-exposes-fauci-pharma-and-the-threat-to-democracy-with-new-film-301636920.html
The Ducks are not all-in-a-row…
Will you Buy The Long Shot by Kate Bingham, or Moonshot by Albert Bourla because you want to know how We made Medical Progress.and Saved the World. Or Robert Kennedy Jr. where it all miraculously failed.
Or David Healy, Or Patrick D. Hahn, Or Jim Gottstein – “And that’s part of our world.”
Andrew Witty hasn’t written a book.
Matt’s book…
A spokesperson for Hancock said he would publish his version of events in a book to be published later this year, the royalties of which will be given to NHS charities.
https://www.theguardian.com/world/2022/oct/09/ex-vaccine-head-kate-bingham-accuses-matt-hancock-behaviour-in-meeting
“The vaccine effort was a massive success and a huge team effort from the NHS to the vaccine taskforce, Oxford University to AstraZeneca. Matt is proud that he insisted that everyone across the UK had access to a vaccine, and is delighted the vaccine programme got the UK out of the pandemic ahead of almost everywhere else in the world.
‘You’ll have to read Matt’s book to find out what really happened,” the spokesperson said.
The coroner noted that on April 7 2021 the Medicines and Healthcare Products Regulatory Agency, responsible for ensuring medicines are safe, issued new advice to healthcare professionals on a “possible link” between the AstraZenca Covid-19 vaccine and specific types of blood clot.
https://www.msn.com/en-gb/health/other/trainee-solicitor-died-from-e2-80-98rare-complication-e2-80-99-of-astrazeneca-covid-19-jab/ar-AA12IeFH
Shots across the Bows…
Lies My Gov’t Told Me: And the Better Future Coming
(Children’s Health Defense)
Hardcover – November 22, 2022
by Robert W. Malone (Author)
https://www.amazon.com/Lies-My-Govt-Told-Me/dp/151077324X
the FDA is using the COVID-19 Vaccines as a “Platform Technology” for mRNA Vaccine Trials. Which would mean that every male patient aged 18-39 enrolled or about to be enrolled in those trials could be at risk for an 84% increase in the relative incidence of cardiac-related death.
I just hope that these subjects are being provided with a balanced and accurate disclosure of risk as they are presented with their “informed consent” paperwork.
The Calm COVID Truth of Dr. Joe Ladapo
Florida Surgeon Generals’ remarkable calm in issuing updated mRNA vaccine guidance
https://rwmalonemd.substack.com/p/the-calm-covid-truth-of-dr-joe-ladapo?sd=pf
“Today, we released an analysis on COVID-19 mRNA vaccines the public needs to be aware of. This analysis showed an increased risk of cardiac-related death among men 18-39. FL will not be silent on the truth,” Ladapo tweeted, citing an analysis conducted by Florida’s health department that stated that the vaccine poses a “high risk” of death.
2 of 2 (Go to web site to see images of speakers and programme)
Will you be in Copenhagen, 24-25 October 2022?
Inbox
Maryanne Demasi, PhD from
1:47 AM (9 hours ago)
to me
https://substackcdn.com/image/fetch/f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fbucketeer-e05bbc84-baa3-437e-9518-adb32be77984.s3.amazonaws.com%2Fpublic%2Fimages%2Fc6e702ed-5310-47a9-9b90-6cb1c090ffa5_1380x785.pngOpen in browser
Will you be in Copenhagen, 24-25 October 2022?
If not, you can attend the conference virtually via zoom
Maryanne Demasi, PhD
Oct 10
Why?
The decline in scientific freedom has been particularly visible during the COVID-19 pandemic. Those who questioned the narrative were crushed, effectively creating the illusion that there was a ‘scientific consensus’ on how to manage the pandemic.
As governments continue to collude with Big Tech / fact-checkers to control public information, a group of us will gather in Copenhagen to present our research and discuss the current problems with evidence-based medicine and scientific censorship.
Who?
The Centre for Evidence-Based Medicine (CEBM) in Oxford and the Institute for Scientific Freedom in Denmark, present “The lack of scientific freedom: causes, consequences and cures”
If you cannot attend in person, you can register to attend virtually via zoom [HERE]
When?
24th and 25th October 2022
Where?
Copenhagen, Denmark
Day 1 – Community Hall (1st floor), Mellemfolkeligt Samvirke, Fælledvej 12
Day 2 -Mødelokale 1, Kulturhuset, Charlotte Ammundsens Plads 3
2-day program
For those who are attending virtually, you will receive a direct link to join before the sessions.
Informal dinner at 18:00 at your own cost. Please make your booking [HERE]
Hope to see you there!
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Maryanne Demasi, PhD from Maryanne Demasi, reports
1:47 AM (9 hours ago)
Maryanne Demasi, PhD
Oct 10
I really like Havel’s ‘Power of the Powerless’ – and, by gum, have I come up against it this morning!
I’ve come across it online – where ‘tech’, supposedly preferential to paper these days, has let me down miserably.
I have met it at the doctor’s surgery – being told that only “a phone call” between 8 and 11 a.m. will get me an appointment, the receptionist in front of me at 10 o’clock could do nothing about it!
At the same place, a few minutes later, I was told about an appointment of mine for a blood test on Wednesday. I haven’t requested such a thing. A doctor won’t have requested it as I haven’t seen one for years. Where had that come from? I was told ” it’s here, in the system – for Wednesday. What’s your full name, date of birth – yes – here look”, at which point I looked at the screen and told the receptionist to send a reply “to the system” that I will most certainly not be turning up for it!
After that I went to collect medication from the pharmacy. Lined up in a queue right through the shop and almost out on to the pavement. I was lucky – the medication was ready and waiting ( although it couldn’t be found twice last week!) and handed over when it became my turn. Of all those ahead of me in the queue, I was the first one to actually be handed the package for which I had queued. The rest were told a variety of excuses for the no-show of their expected packages. ” Still waiting for that medication to be available”, “still waiting for the doctor to sign the script and send it over”, ” it’s come back from the doctor but it’s now out at the distributors and will be here tomorrow” – these were some of the explanations that I heard given.
If “tech” in all its guises is so wonderful, why have I and countless others had such a horrific morning of it? Bring back ‘accountability’ in human form – we can make sense between us; being able to blame “the tech” lets so many of us off the hook and the rest helpless in finding support where it’s needed.
Children being used as Tech Rats in Cambridge The stuff of nightmares.
Robots could help detect mental wellbeing issues in children, study finds
Although the robots are not intended to be used as a substitute for medical professionals, researchers say they could be a useful addition to methods of mental health assessment.
Thursday 1 September 2022 01:36, UK
Researchers got a child-sized humanoid robot to complete a series of questionnaires with children. Pic: Cambridge University handout/PA
Image:
Each child took part in a one-to-one session with a Nao robot. Pic: Cambridge University handout/PA
Robots could help to detect mental wellbeing issues in children, a study has suggested.
A child-sized humanoid robot was used by Cambridge University researchers to complete a series of questionnaires to assess mental wellbeing with 28 children aged between eight and 13.
The research found that the youngsters were willing to confide in the robot, sometimes sharing information that they had not yet shared via online or during in-person questionnaires.
Although the robots are not intended to be used as a substitute for mental health support, researchers say they could be a useful addition to methods of mental health assessment.
PhD student Nida Itrat Abbasi, the study’s first author, said: “Since the robot we use is child-sized, and completely non-threatening, children might see the robot as a confidante – they feel like they won’t get into trouble if they share secrets with it.
“Other researchers have found that children are more likely to divulge private information – like that they’re being bullied, for example – to a robot than they would be to an adult.”
Each child had a 45-minute, one-to-one session with a Nao robot, which is a humanoid robot around 60cm tall.
The children interacted with the robot by speaking with it, or by touching sensors on the robot’s hands and feet. Additional sensors tracked their heartbeat, head and eye movements during the session.
Children ‘more engaged’ by robots than screens
Professor Hatice Gunes, who leads the Affective Intelligence and Robotics Laboratory in Cambridge’s Department of Computer Science and Technology, has been studying how socially assistive robots can be used as mental wellbeing coaches for adults.
In recent years, she has also been studying how they may benefit children.
She said children are “quite tactile” and “drawn to technology”.
“If they’re using a screen-based tool, they’re withdrawn from the physical world.
“But robots are perfect because they’re in the physical world – they’re more interactive, so the children are more engaged,” she added.
Please help me robot friend I am only 6mths old and we children have no-one we can trust U.S. Food and Drug Administration
FDA NEWS RELEASE
Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age
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For Immediate Release:
June 17, 2022
Today, the U.S. Food and Drug Administration authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age.
For the Moderna COVID-19 Vaccine, the FDA amended the emergency use authorization (EUA) to include use of the vaccine in individuals 6 months through 17 years of age. The vaccine had been authorized for use in adults 18 years of age and older.
For the Pfizer-BioNTech COVID-19 Vaccine, the FDA amended the EUA to include use of the vaccine in individuals 6 months through 4 years of age. The vaccine had been authorized for use in individuals 5 years of age and older. ………………
AntiDepAware
@AntiDepAware
·
Oct 9
Killed by #Citalopram Aided and abetted by the @MHRAmedicines
#FirstAdmitNoHarm
https://judiciary.uk/wp-content/uploads/2021/01/2020-0276-Response-from-MHRA-Redacted.pdf
MHRA replies to Coroner Regulation 28 report to prevent future deaths
https://www.judiciary.uk/wp-content/uploads/2021/01/2020-0276-Response-from-MHRA-Redacted.pdf
The Battle of the Bilge…
The highlighed info doesn’t work (above) Here is the full programme and speakers. And
change of venue.
Lack of scientific freedom: causes, consequences and cures
Monday, 24 October 2022 to Tuesday, 25 October 2022
Copenhagen Denmark
Change of venue
24 October 2022: Community Hall (1st floor), Mellemfolkeligt Samvirke, Fælledvej 12
25 October 2022: Mødelokale 1, Kulturhuset, Charlotte Ammundsens Plads 3
Both venues are within walking distance of recommend hotels Hotel Kong Arthur and Ibsens Hotel
When you arrive at Kastrup airport, take the metro, direction Vanløse, and get off at Nørreport.
For those attending virtually, you will receive a ZOOM link to join before the sessions, please ensure you have the latest version of Zoom
downloaded on to your device.
The lack of scientific freedom: causes, consequences and cures
24 October 2022: Community Hall (1st floor), Mellemfolkeligt Samvirke, Fælledvej 12
25 October 2022: Mødelokale 1, Kulturhuset, Charlotte Ammundsens Plads 3
Centre for Evidence-Based Medicine in Oxford and the Institute for Scientific Freedom in Copenhagen
Lectures: 20 min presentation, 20 min discussion. Abstract sessions: 10 min presentations, 20 min panel discussion
Day One – Monday October 24
08:30 Registration & Coffee
09:00 – 09:40 What does the current system look like? Is it evidence-based medicine?
Carl Heneghan, Director, Centre for Evidence-Based Medicine, Oxford, UK
09:40 – 10:40
Four presentations based on submitted abstracts
David Doat – The misuse(s) of scientific consensus in Covid-19 pandemic
Sara Gandini – The attack on children. The attack on schools. The attack on Gandini.
Manfred Horst – US mortality in the “pandemic” year 2020
Harald Walach – How the Covid-19 pandemic generates censorship – A case study of two falsely retracted studies and
insights from interviewing media experts
10:40 – 11:00 Coffee
11:00 – 11:40 The “three legged stool” of the prevalent COVID 19 narrative: numbers of cases, hospital admissions and deaths
Tom Jefferson, Professor, Oxford, UK
11:40 – 12:40
Four presentations based on submitted abstracts
Manfred Horst – clincal relevance of the Covid-19 vaccine trials
Leemon McHenry – On Censorship and Retraction: Pharmaceutical Industry Sponsored Psychiatric Clinical Trials
Robert Freudenthal – The forced abandonment of relational mental healthcare
Charles Bennett – Davids versus Goliaths: Case series of 26 clinicians and scientists who were intimidated and threatened by
academia and pharma after communicating findings contrary to corporate interests
12:40 – 13:30 Lunch
13:30 – 14:10 Scientific censorship and pervasive corruption in psychiatry
Robert Whitaker, Science Journalist, Boston, USA
14:10 – 14:50 Failure of drug regulation: declining standards, lack of transparency and institutional corruption
Maryanne Demasi, PhD and journalist, Sydney, Australia
14:50 – 15:10 Coffee
15:10 – 16:10
Four presentations based on submitted abstracts
Harvey Risch – Mass messaging of plausibility instead of scientific evidence
Nicolas Vermeulen – Threat and Fear influence individual and Collective Decisions
Pawel Zagozdzon – Paradigms shifts in public health during COVID-19 pandemic
Peter Gøtzsche – Much of what is claimed in psychiatric textbooks is dangerous and amounts to scientific dishonesty
16:10 – 16:50 Silencing whistle-blowers and refusing to retract fraudulent papers
Peter Wilmshurst, Cardiologist, Stoke-on-Trent, UK
18:00 Informal dinner at own cost
Day Two – Tuesday October 25
08:30 – 09:00 Coffee
09:00 – 09:40 The Chinese-US joint cover up of the origin of COVID-19
Peter C Gøtzsche, Director, Institute for Scientific Freedom, Copenhagen, Denmark
09:40 – 10:20
What happens when a scientist gets results about COVID-19 that are unwelcome?
John PA Ioannidis, Professor, University of Stanford, California
10:20 – 10:40 Coffee
10:40 – 11:20 The deadly consequences of ignoring drug utilization data
Joan-Ramon Laporte, Founder and Director, Butlletí Groc, Barcelona, Spain
11:20 – 11:30 Comfort break
11:30 – 12:10 Opening company archives in lawsuits and exposing the fraud in clinical trials
Kim Witczak, Drug Safety and Consumer Advocate, Los Angeles, California
12:10 – 13:00 Lunch
13:00 – 13:40 What might a totally new system look like?
David Hammerstein, Director, Commons Network, previous MEP, Valencia, Spain
13:40 – 14:00 Coffee – Safe journey home
14:00 – 17:00 Faculty Meeting (closed)
Edward DowdReposted
Jane
@Scandy16
Replying to @edwarddowd
We have known this fact but most of the rest of the world still doesn’t. This MEP’s tweet is getting good traction (nearly 40k retweets so far). The Pfizer exec’s dismissive chuckle when she answers is truly despicable.
https://twitter.com/rob_roos/status…
Rob Roos MEP
@Rob_Roos
BREAKING: In COVID hearing, #Pfizer director admits: #vaccine was never tested on preventing transmission.
“Get vaccinated for others” was always a lie.
The only purpose of the #COVID passport: forcing people to get vaccinated. The world needs to know.
Share this video!
https://twitter.com/rob_roos/status/1579759795225198593?s=21&t=ZOv08VzOBH8RSYXqZMCA2A
Pfizer Exec Concedes COVID-19 Vaccine Was Not Tested on Preventing Transmission Before Release
By Jack Phillips
October 11, 2022 Updated: October 11, 2022
https://www.theepochtimes.com/pfizer-exec-concedes-covid-19-vaccine-was-never-tested-on-preventing-transmission_4788577.html
A Pfizer executive said Monday that neither she nor other Pfizer officials knew whether its COVID-19 vaccine would stop transmission before entering the market last year.
Member of the European Parliament, Rob Roos, asked during a session: “Was the Pfizer COVID vaccine tested on stopping the transmission of the virus before it entered the market? Did we know about stopping immunization before it entered the market?”
Pfizer’s Janine Small, president of international developed markets, said in response: “No … You know, we had to … really move at the speed of science to know what is taking place in the market.”
Roos, of the Netherlands, argued in a Twitter video Monday that following Small’s comments to him, millions of people around the world were duped by pharmaceutical companies and governments.
“Millions of people worldwide felt forced to get vaccinated because of the myth that ‘you do it for others,’” Roos said. “Now, this turned out to be a cheap lie” and “should be exposed,” he added.
The Epoch Times has contacted Pfizer for comment.
What Was Said
The Food and Drug Administration wrote in late 2020 that there was no data available to determine whether the vaccine would prevent transmission and for how long it would protect against transmission of the SARS-CoV-2 virus that causes COVID-19.
“At this time, data are not available to make a determination about how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person,” the agency specifically noted.
Meanwhile, Pfizer CEO Albert Bourla, around the same time, said his firm was “not certain” if those who receive its mRNA vaccine will be able to transmit COVID-19 to other people.
”I think this is something that needs to be examined. We are not certain about that right now,” Bourla told NBC News in December 2020 in response to a question about transmissibility.
Former White House medical adviser Dr. Deborah Birx in June revealed that there was evidence in December 2020 that individuals who received COVID-19 vaccines, including Pfizer’s, could still transmit the virus.
We knew early on in January of 2021, in late December of 2020, that reinfection was occurring after natural infection,” Birx, the White House COVID-19 response coordinator during the Trump administration, told members of Congress this year.
‘Not Going to Get COVID’
A number of officials in the United States and around the world had claimed COVID-19 vaccines could prevent transmission. Among them, President Joe Biden in July 2021 remarked that “you’re not going to get COVID if you have these vaccinations.”
Chief Biden administration medical adviser Anthony Fauci in May 2021 said in a CBS interview that vaccinated people are “dead ends” for COVID-19, suggesting they cannot transmit the virus. “When you get vaccinated, you not only protect your own health and that of the family but also you contribute to the community health by preventing the spread of the virus throughout the community,” Fauci said.
Two months later, in late July of that year, Fauci said that vaccinated people are capable of transmitting the virus.
In the coming months, Fauci, Biden, CDC Director Dr. Rochelle Walensky, and others pivoted to say the vaccine prevents severe disease, hospitalization, and death from COVID-19.
Rob Roos MEP Retweeted
GB News
@GBNEWS
‘Pfizer was very clear in speaking out.’ Robert Roos MEP, Vice-Chair of the European Conservatives and Reformists group, speaks to Mark Steyn as the European Union Covid Committee questions Pfizer.
GB News YouTube: https://bit.ly/3vAYaw0
https://www.youtube.com/watch?v=TMFrOIebS0k
Rob Roos MEP
@Rob_Roos
https://twitter.com/Rob_Roos
What a Roos…
GB News Clouted…
GB News faces second Ofcom inquiry into Covid vaccine coverage
Jim Waterson Media editor – 50m ago
https://www.msn.com/en-gb/health/other/gb-news-faces-second-ofcom-inquiry-into-covid-vaccine-coverage/ar-AA12SFNA?ocid=msedgdhp&pc=U531&cvid=b669f056313e4eb487b04001c120dfdc
GB News is facing a second investigation by the media regulator Ofcom over its coverage of the coronavirus vaccine.
The latest investigation relates to an interview with the author Naomi Wolf in which she claimed women were being harmed by Covid-19 vaccines as part of an effort to “to destroy British civil society”.
Ofcom said it would investigate whether the programme broke “rules designed to protect viewers from harmful material” after receiving more than 400 complaints from members of the public.
In the interview, which was originally broadcast on 4 October, Wolf also compared doctors’ support for the vaccine rollout to the behaviour of the medical profession in Nazi Germany and described herself as the “last remaining independent journalist” willing to question this.
She was being interviewed on the Mark Steyn Show, which has repeatedly doubts over the safety of vaccines. Steyn’s claims that the jabs cause “every conceivable kind of damage” have been disputed by factchecking websites. He is already the subject of a separate Ofcom investigation over previous comments about vaccination.
Wolf began as prominent a feminist writer but in recent years her career has taken a hit after she wrote a book partly based on a misunderstanding of English court records. Since then she has veered into the world of conspiracy theories about the impact of 5G telephone masts and the coronavirus vaccine.
Presenter Matthew Sweet, whose BBC interview exposed the flaw in Wolf’s book, has since kept tabs on her work and GB News’s coverage of the pandemic and accused the channel of repeatedly “broadcasting misinformation about vaccines and presenting conspiracy theorists as legitimate experts on medical matters”.
In a letter to Sweet tweeted last month, GB News insisted that at no point had Steyn’s programme adopted an “anti-vax” approach. Instead it said he was conducting probing journalism in the face of people who want GB News to be “more supportive of government policy”.
Mark Steyn confirms second person will receive a vaccine payout after losing dad following AstraZeneca jab
https://www.gbnews.uk/news/mark-steyn-confirms-second-person-will-receive-a-vaccine-payout-after-losing-dad-following-astrazeneca-jab/323222
GB News exclusively revealed earlier this week that Vikki Spit, a woman whose 48-year-old fiancé Lord Zion died two weeks after having the AstraZeneca jab, will become the first person in the UK to receive a Covid vaccine damage payment.
She also paid tribute to the support GB News has provided her, adding: “I’m certain that if we hadn’t kicked up a fuss and come onto GB News with Mark, this never would have happened.”
GBN BRITAIN’S NEWS CHANNEL…
Dr Aseem Malhotra
@DrAseemMalhotra
THIS
GB News
@GBNEWS
·
8h
‘Facebook and Mark Zuckerberg are the enemy of democracy.’ Consultant cardiologist Dr Aseem Malhotra speaks to Mark Steyn after being suspended on the social media site for sharing vaccine data analysis.
Dr Aseem Malhotra
@DrAseemMalhotra
·
7m
THIS
Aaron Kheriaty, MD
@akheriaty
·
4h
FDA is off the rails. Off. The. Rails. Reckless. Endangerment. Of children. Children. twitter.com/MaryanneDemasi…
Maryanne Demasi, PhD
@MaryanneDemasi
·
10h
This is wild! The @US_FDA has violated its oath to protect public health. The FDA grants Pfizer an EUA for its bivalent covid vaccine in 5-11yr olds. It has not been tested in kids, a cohort which has virtually no benefit and likely to experience harm. twitter.com/AlbertBourla/s…
Albert Bourla
@AlbertBourla
·
19h
I’m pleased to share that we have received Emergency Use Authorization from the @US_FDA for our Omicron BA.4/BA.5-adapted #COVID19 vaccine for children aged 5-11. This is an important milestone as we head into the winter months ahead:
https://on.pfizer.com/3MtRKW2
EU Press Conference After Pfizer’s Laughable Showing – Bourla MIA
This press conference took place on Tuesday, under the leadership of Romanian MEP Cristian Terhes with his valiant team of MEPs willing to stand up to big pharma tyranny of over 500 million EU citizens. His team seems to be expanding.
Here is a sample of points made. We recommend listening to the full video of 26 minutes.
Cristian Terhes MEP lets off some ‘Fire-Crackers’
– the video
https://www.europereloaded.com/eu-press-conference-after-pfizers-shameful-showing/
“This is wild!”…
Revealed: PR firm that represents Pfizer and Moderna also sits on CDC vaccine division – sparking major conflict of interest concerns
Weber Shandwick is helping run communications around the vaccine program
But the PR group is already working for Moderna, and has worked for Pfizer
Critics slammed the CDC’s hire today as ‘irresponsible’, it was revealed
By LUKE ANDREWS HEALTH REPORTER FOR DAILYMAIL.COM
PUBLISHED: 17:16, 12 October 2022 | UPDATED: 19:27, 12 October 2022
https://www.dailymail.co.uk/health/article-11303017/PR-firm-represents-Pfizer-Moderna-sits-CDC-vaccine-advisory-committee.html
A PR company that represents Pfizer and Moderna has staff ’embedded’ in the CDC’s vaccine division, it has emerged.
New York-based firm Weber Shandwick has been responsible for elevating Pfizer’s profile since at least 2006. It partnered with Moderna in June this year, after the small biotech firm became a household name following its vaccine success.
Yet questions are being raised about a possible conflict of interest as it emerged the company was hired by the Centers for Disease Control and Prevention (CDC) during the pandemic to boost its ‘health communication’.
It was involved in PR campaigns that encouraged Americans to get vaccinated against Covid.
But a spokesperson for Weber Shandwick told DailyMail.com it had a ‘thorough vetting and mitigation process to avoid conflicts’.
Vaccine makers made more than $34billion in profits last year from the Covid jabs alone — equivalent to $1,000 a second, according to estimates.
They are expected to make billions more from the bivalent booster jabs being rolled out this winter — with the US having bought 171million doses.
Weber Shandwick works for the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD).
The potential conflict of interest was brought to attention in a LinkedIn post by an employee of the PR firm last year.
They wrote on the social media site: ‘So excited to be starting a new role today! I’m joining Weber Shandwick as an Account Director supporting a contract I know well, at the CDC’s NCIRD!’
Today the updated shots — which tackle Omicron variants — got the green light for children as young as five years old. They are currently recommended for all over-12s.
Another employee replied: ‘Welcome back to the team!’
In 2020 Weber Shandwick also won an up to $50million contract from the US Government to promote flu vaccines to the public.
Its responsibilities included distributing social media posts and articles promoting vaccines, and sending press releases to the media.
It was also involved in ‘paid media placement’, a common euphemism for advertising.
The firm was employed by Moderna in June this year alongside two other PR firms to promote its mRNA vaccine – despite being a direct rival to Pfizer.
Weber Shandwick is also a long-time client of Pfizer’s, having been brought on back in 2003 to assist with marketing around Viagra pills and other treatments.
Responding to DailyMail.com today, a spokesperson for Weber Shandwick said: ‘We are proud of the important work we do to advance public health.
‘When we work for organizations in the same sector, we have a thorough vetting and mitigation process to avoid conflicts, including legal review, separate and distinct teams and strong confidentiality protocols.’
DailyMail.com has approached the CDC for comment.
Craig Holman, a lobbyist on Capitol Hill for Public Citizen, blasted the CDC today for the conflict of interest.
‘This is irresponsible of CDC to issue a PR contract to Weber Shandwick,’ he told the site DisInformation. ‘Knowing that the firm also works for Moderna and Pfizer’.
Pfizer and Moderna’s jabs have formed the cornerstone of America’s vaccine roll out, with more than 800million doses ordered at a cost of more than $10billion.
The two companies were also the only ones to sell updated bivalent booster shots to America this year — which target Omicron variants BA.4 and BA.5.
More than 42million doses of these have been delivered so far, at a cost that is yet to be revealed.
But the bivalent jab rollout has got off to a slow start despite calls from the White House for everyone to get doses.
Just six per cent of all over-12s have come forward.
Meanwhile, today the Food and Drug Administration (FDA) revealed it was expanding eligibility of the new vaccine to young children.
It gave the green-light for Moderna’s updated shot to be given to six year olds, and Pfizer’s to those as young as five.
This will still need to be signed off by the CDC, but suggests that the beleaguered program will be expanded to more age groups.
The beleaguered CDC saw public trust in the agency erode during the Covid pandemic after a litany of errors.
It was slow to recommend face masks in the early days, or to warn that Covid was likely spreading through the air.
Later in the pandemic it has also signed off on Covid vaccines for children as young as six months old.
The move has faced criticism from many experts because of the vanishingly small risk very young children face of death or serious disease from the virus.
Um, back to the Roos…
Dr Aseem Malhotra
@DrAseemMalhotra
·
28m
People should listen to the very articulate nurse practitioner John Campbell
Kat A
@SaiKate108
·
20h
Dr John Campbell usually so cool, calm and collected can no longer hide his contempt! ‘I’ll pause and explain what the speed of science means, they haven’t got a flipping clue’
https://www.youtube.com/watch?v=J6VbI8gOnUM&feature=emb_logo
“The Speed of Science –
“Everything at Risk –
“Uh, these, um, you know, we had to really move at the speed of science to really understand what is taking place in the market, and from that point of view we had to do everything at risk. I think Dr Bourla, even though he’s not here, would turn around and say to you himself, ‘If not us then who?’”
‘Um, we’ll leave it there and thank you for watching…
Pflipping clue…
Albert Bourla
@AlbertBourla
·
Oct 12
We’ve come a long way since 2020 in reducing #COVID19 hospitalizations & deaths. Among Medicare beneficiaries, for example, we saw a 39-47% reduction in these outcomes due to vaccinations in 2021. Thanks for believing in the power of science!
‘As I’ve said before, we are operating at the speed of science.’
‘meaning it can help prevent COVID-19 disease in at least a majority of vaccinated patients.’
https://www.pfizer.com/news/articles/an_open_letter_from_pfizer_chairman_and_ceo_albert_bourla
The Pfower and the Speed…
PM: Canada will get millions of doses of Pfizer vax for kids
https://www.youtube.com/watch?v=77j3TUllAF0
“we did a deal with Pfizer”
GB News
@GBNEWS
‘He’s setting people up as being lesser, as being other, as being despicable, as being guilty of things that are socially unacceptable’ Neil Oliver discusses Canadian PM Justin Trudeau’s claims about the unvaccinated with Dan Wootton.
https://twitter.com/GBNEWS/status/1478127096014807042
“borderline criminal”
GBNews
@GBNews
Mark Dolan reacts to Pfizer admitting that the vaccine was never tested for transmission
Take it to protect Granny…
https://www.youtube.com/watch?v=QNLHjbS7FL0
Never Forgive. Never Forget. And. Never Again…
6 Violations for Pfizer since t he beginning of the epidemic although they must have been at it before then to have got pfizzing in time to for the ‘jabbing; to begin. All Consumer Protection Violations. Surely more should be added by now….
For list of Violations by other companies ,with evidence, type in name of pharma co. on ‘Violations Tracker.’
Violation Tracker Current Parent Company Summary
Current Parent Company Name: Pfizer
Penalty total since 2000: $10,268,633,525
Number of records: 91
TOP 5 OFFENSE GROUPS (GROUPS DEFINED) PENALTY TOTAL NUMBER OF RECORDS
safety-related offenses $5,637,024,615 16
healthcare-related offenses $3,373,675,000 10
government-contracting-related offenses $1,148,191,225 20
competition-related offenses $98,166,568 8
environment-related offenses $5,629,098 26
TOP 5 PRIMARY OFFENSE TYPES PENALTY TOTAL NUMBER OF RECORDS
drug or medical equipment safety violation $5,636,840,000 9
off-label or unapproved promotion of medical products $3,373,675,000 10
False Claims Act and related $1,148,191,225 20
Foreign Corrupt Practices Act $60,216,568 3
kickbacks and bribery $34,700,000 3
Notes: Parent-subsidiary linkages are based on relationships current as of the latest revision listed in the Update Log,
Links: Subsidy Tracker data on financial assistance to this company by federal, state and local government agencies can be found here.
For an overview of assistance this company is receiving under the CARES Act, see its Covid Stimulus Watch summary page here.
American Home Products drug or medical equipment safety violation 2002 private lawsuit-federal $3,750,000,000
Pfizer Inc. off-label or unapproved promotion of medical products 2009 FDA $2,300,000,000
Pfizer Inc. False Claims Act and related 2016 DOJ_CIVIL $784,600,000
Pfizer drug or medical equipment safety violation 2004 private lawsuit-federal $750,000,000
Pfizer drug or medical equipment safety violation 2008 private lawsuit-federal $745,000,000
Wyeth Pharmaceuticals Inc. off-label or unapproved promotion of medical products 2013 FDA $490,900,000
Warner-Lambert off-label or unapproved promotion of medical products 2004 FDA $430,000,000
Wyeth Pharmaceuticals, Inc. False Claims Act and related 2016 MULTI-AG (*) $371,351,180
Pfizer, Inc. kickbacks and bribery 2009 MULTI-AG (*) $331,485,170
Pfizer drug or medical equipment safety violation 2013 private lawsuit-federal $288,000,000
Wyeth Pharmaceuticals, Inc. off-label or unapproved promotion of medical products 2013 MULTI-AG (*) $257,400,000
Warner-Lambert off-label or unapproved promotion of medical products 2004 MULTI-AG (*) $190,000,000
King Pharmaceuticals False Claims Act and related 2005 DOJ_CIVIL $124,000,000
King Pharmaceuticals False Claims Act and related 2006 MULTI-AG (*) $124,000,000
Pfizer Inc. off-label or unapproved promotion of medical products 2008 MULTI-AG $60,000,000
Pfizer Inc. drug or medical equipment safety violation 2012 FDA $55,000,000
Pfizer Corporation False Claims Act and related 2002 DOJ_CIVIL $49,000,000
Pfizer Inc. off-label or unapproved promotion of medical products 2012 MULTI-AG $42,900,000
Alpharma Inc. False Claims Act and related 2010 DOJ_CIVIL $42,500,000
Pfizer Inc. False Claims Act and related 2019 IL-AG $41,047,101
Pfizer off-label or unapproved promotion of medical products 2014 MULTI-AG $35,000,000
Wyeth-Ayerst Laboratories Division drug or medical equipment safety violation 2000 FDA $30,000,000
Pharmacia Corporation False Claims Act and related 2013 WI-AG $29,453,247
Pfizer Inc. Foreign Corrupt Practices Act 2012 SEC $26,339,944
Pfizer, Inc. False Claims Act and related 2018 DOJ_CIVIL $23,850,000
Pfizer Inc. False Claims Act and related 2002 MULTI-AG (*) $21,084,700
Pharmacia & Upjohn Company Inc. kickbacks and bribery 2007 USAO $19,700,000
Pharmacia Corporation False Claims Act and related 2019 IL-AG $18,960,210
Wyeth LLC Foreign Corrupt Practices Act 2012 SEC $18,876,624
Pfizer Inc. False Claims Act and related 2013 TX-AG $18,170,000
Pfizer H.C.P. Corporation Foreign Corrupt Practices Act 2012 DOJ_CRIMINAL $15,000,000
Pharmacia & Upjohn Company LLC kickbacks and bribery 2007 USAO $15,000,000
Pfizer Inc. off-label or unapproved promotion of medical products 2011 FDA $14,500,000
Pfizer Inc. drug or medical equipment safety violation 2014 NV-AG $9,500,000
Alpharma Inc. False Claims Act and related 2010 MULTI-AG (*) $8,900,000
Pfizer, Inc. and Pharmacia Corporation False Claims Act and related 2010 HI-AG $8,200,000
Pfizer drug or medical equipment safety violation 2003 MULTI-AG $6,000,000
Pfizer, Inc. drug or medical equipment safety violation 2012 OR-AG $3,340,000
Pfizer Inc. and Pharmacia Corp. False Claims Act and related 2012 ID-AG $2,900,000
Pfizer Inc. False Claims Act and related 2011 MULTI-AG (*) $2,621,154
Alpharma, Inc. price-fixing or anti-competitive practices 2004 FTC $2,500,000
Pharmacia Corporation False Claims Act and related 2011 NY-AG $2,500,000
King Pharmaceuticals LLC environmental violation 2013 EPA $2,200,000
KING PHARMACEUTICALS environmental violation 2013 EPA (*) $2,200,000
Purepac Pharmaceutical Co., n/k/a Actavis Elizabeth, LLC False Claims Act and related 2011 MS-AG $2,010,667
Wyeth benefit plan administrator violation 2013 private lawsuit-federal $2,000,000
Pfizer employment discrimination 2009 private lawsuit-federal $1,365,003
Pfizer Inc. environmental violation 2008 EPA $975,000
Pfizer consumer protection violation 2019 OR-AG $975,000
PFIZER GLOBAL MANUFACTURING environmental violation 2008 EPA (*) $975,000
Alpharma, Inc. price-fixing or anti-competitive practices 2004 MULTI-AG $750,000
Pfizer Pharmaceuticals LLC environmental violation 2014 EPA $728,000
Pfizer Pharmaceuticals, LLC environmental violation 2014 EPA (*) $728,000
Pfizer Inc. consumer protection violation 2018 NY-AG $700,000
Pharmacia & Upjohn Company environmental violation 2005 EPA $676,250
Purepac Pharmaceutical Co. False Claims Act and related 2010 ID-AG $600,000
Hospira Inc. employment discrimination 2015 OFCCP $400,000
Pharmacia Corp. False Claims Act and related 2009 OH-AG $400,000
Pfizer Inc. off-label or unapproved promotion of medical products 2013 MA-AG $375,000
PHARMACIA/SOLUTIA environmental violation 2007 IL-ENV $210,000
Pfizer Pharmaceuticals, LLC environmental violation 2016 EPA $190,000
Pfizer consumer protection violation 2022 CO-AG $137,174
HOSPIRA, INC. workplace safety or health violation 2004 OSHA $132,300
Pfizer consumer protection violation 2022 AZ-AG $124,527
PHARMACIA CORPORATION, et al. environmental violation 2009 IL-ENV $96,000
SEARLE LTD environmental violation 2002 EPA $95,000
Pfizer Inc. consumer protection violation 2022 KS-AG $85,564
Pfizer, Inc. consumer protection violation 2022 KS-AG $85,000
Wyeth Pharmaceuticals Company, Inc. environmental violation 2010 EPA $77,000
Pfizer Pharmaceuticals LLC environmental violation 2005 EPA $55,000
Wyeth Rouses Point environmental violation 2008 EPA $44,500
Pfizer Inc. environmental violation 2006 CT-ENV $40,224
Wyeth Biopharma wage and hour violation 2005 WHD $40,187
Wyeth Ayerst Pharmaceuticals environmental violation 2004 EPA $37,000
Pfizer consumer protection violation 2022 VT-AG $34,564
Pharmacia and Upjohn Company LLC environmental violation 2017 EPA $34,170
Pfizer, Inc. environmental violation 2010 CT-ENV $31,266
PHARMACIA & UPJOHN CARIBE environmental violation 2001 EPA $27,168
WYETH PHARMACEUTICALS COMPANY – OTC environmental violation 2000 EPA $25,000
Pfizer Pharmaceuticals environmental violation 2010 EPA $24,650
PFIZER INC / GROTON SITE environmental violation 2005 EPA $22,500
Pfizer Pharmaceuticals Ltd. environmental violation 2004 EPA $20,025
Pfizer Inc. railroad safety violation 2002 FRA $11,250
PFIZER, INC. workplace safety or health violation 2021 OSHA $10,360
PFIZER, INC. workplace safety or health violation 2012 OSHA $9,600
PHARMACIA CORP environmental violation 2002 NJ-ENV $8,625
KING PHARMACEUTICALS workplace safety or health violation 2001 OSHA $7,200
PFIZER, INC. workplace safety or health violation 2009 OSHA $7,155
HOSPIRA workplace safety or health violation 2006 OSHA $6,750
Pfizer Inc. environmental violation 2012 CA-DPR $6,720
PHARMACIA & UPJOHN COMPANY, LLC. environmental violation 2004 EPA $5,000
(*): Penalty amounts marked by an asterisk are ones announced by more than one agency. Parent penalty totals are adjusted to avoid double-counting.
Social media has been in an uproar since a member of European Parliament posted a video of a hearing in which a Pfizer director admitted the company never tested whether its Covid mRNA vaccine prevents transmission prior to its approval for emergency use.
“Mature” …
Pfizer/BioNTech announce positive early data from trial of BA.4/BA.5 COVID-19 booster
A 30µg dose of the booster demonstrated a ‘substantial increase’ in antibody response
https://www.pmlive.com/pharma_news/pfizerbiontech_announce_positive_early_data_from_trial_of_ba.4ba.5_covid-19_booster_1456809
Commenting on the positive results, Albert Bourla, chairman and chief executive officer, Pfizer, said: “While we expect more mature immune response data from the clinical trial of our Omicron BA.4/BA.5-adapted bivalent vaccine in the coming weeks, we are pleased to see encouraging responses just one week after vaccination in younger and older adults.”
Edward DowdReposted
rwmalonemd
@rwmalonemd
A Look Back at the Demonization of the Unvaccinated
Social media has been in an uproar since a member of European Parliament posted a video of a hearing in which a Pfizer director admitted the company never tested whether its Covid mRNA vaccine prevents transmission prior to its approval for emergency use.
Though the fact that Covid mRNA vaccines do not prevent transmission was, of course, abundantly clear from the data soon after their implementation, this myth was a primary justification for vaccine passes and a primary cause of the unprecedented venom launched at those who refused Covid vaccines throughout 2021 and continuing through today.
Not only did governments exert this pressure through policy, but in many cases politicians and officials used their office to deliberately stoke the social stigmatization of the unvaccinated. Here’s a look back at some of the unprecedented vitriol that was launched at those who refused Covid vaccines from 2021 and beyond.
https://michaelpsenger.substack.com/p/a-look-back-at-the-demonization-of
That some healthy young people were surely coerced into receiving an injection that led to their death or serious injury, when the data showed that the benefits did not outweigh the risks, is an unconscionable tragedy.
Sunday with Laura Kuenssberg :
On this week’s show: Chancellor Jeremy Hunt, shadow business secretary Jonathan Reynolds and vaccine firm BioNTech founders Ugur Sahin and Ozlem Tureci
Guests on the panel are Unison union general secretary Christina McAnea, Tesco chairman John Allan and former Health Secretary Matt Hancock
Why did Sunday with Laura Kuenssberg put on a ‘Pharmaceutical Advertisement” ?
‘With Mr and Mrs, Professor and Professor, Ugur Sahin and Ozlem Tureci’
https://www.youtube.com/watch?v=R83JCXSjvJo
‘There is no doubt though that Covid mRNA vaccines have been highly successful and made billions for BioNTech, Pfizer and Moderna.’
https://www.bbc.co.uk/news/health-63247997
In any other instance, a cure for cancer is fantastic news.
However, the whole narrative was spun on the success of the mRNA vaccine roll-out.
Spun-out on the flagship: Sunday with Laura Kuenssberg.
Carl Heneghan on Pfizer admitting they did not know the vaccine’s effects on transmission
https://www.youtube.com/watch?v=VMARtgauosM
…..and former Health Secretary Matt Hancock –
This is the Big Story –
Link it all together and LK, seems a little out of touch……
1 of 1
No balanced coverage of covid vaccines in legacy media, says Peter Doshi
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Oct 17
Prof Peter Doshi, University of Maryland School of Pharmacy, senior editor The BMJ
Peter Doshi, associate professor at the University of Maryland School of Pharmacy and senior editor at The BMJ, has spoken out about how the mainstream media has ignored important data on covid-19 vaccines.
In a recent interview with German TV, Doshi said, “Our legacy media has not done a good job in providing balanced coverage about the vaccines.”
He said there has been “a lot of nervousness” about how to communicate vaccine harms to people and is concerned that “we’re not getting the information we need to make better choices and to have a more informed understanding of risk and benefit.”
Doshi’s concerns extended to the over-confidence of public health authorities engaged in promoting the covid-19 vaccines.
“It was very unfortunate, that from the beginning, what was presented to us by public health officials was a picture of great certainty…but the reality was that there were extremely important unknowns,” said Doshi who has written and spoken about these unknowns, highlighting that even public health officials were aware of these limitations.
“We entered a situation where essentially the stakes became too high to later present that uncertainty to people.” He added, “I think that’s what set us off on the wrong foot. Public officials should have been a lot more forthright about the gaps in our knowledge.”
A pivotal study
Doshi was part of an international group of eminent academic researchers and physicians who went back and re-analysed the safety data from the original randomised clinical trials that underpinned the FDA’s decision to authorise the mRNA vaccines in December 2020.
I reported on the pre-print study, but since then, it has been published in the peer-reviewed journal, Vaccine.
The authors focused on serious adverse events that occurred in the Moderna and Pfizer vaccine trials, events the sponsors classified as “serious” generally because they resulted in hospitalisation.
In short, their analysis showed that mRNA vaccines were associated with 1 additional serious adverse event for every 800 people vaccinated, which Doshi said is “much more common” than what we’ve traditionally observed for other vaccines where the adverse event rate is in the range of 1 to 2 per million vaccinees.
“Just to put that in some perspective, a rate like that in past years has had vaccines taken off the market. In 1976, we saw Guillain Barre Syndrome after influenza vaccines that were then withdrawn.”
The authors of the study also found the trial data showed that the increase in serious adverse events following mRNA vaccination surpassed the reduction in risk of ending up hospitalised with covid-19.
Preventing transmission
Despite public assurances that covid-19 vaccines would save lives and protect the community by preventing transmission, Doshi knew from the outset that it was never properly tested. In Oct 2020, Doshi published an article in The BMJ:
Hospital admissions and deaths from covid-19 are simply too uncommon in the population being studied for an effective vaccine to demonstrate statistically significant differences in a trial of 30 000 people. The same is true of its ability to save lives or prevent transmission: the trials are not designed to find out [emphasis added]
It was, therefore, unsurprising to Doshi that the vaccines failed to stop the spread.
“One of the big reasons is that it’s an intramuscular vaccine, and this doesn’t produce mucosal immunity. Infections of covid, influenza and other acute respiratory infections, start in the mucosal membranes, a place where these vaccines are not particularly good, historically, at producing immunity antibodies” said Doshi.
Calling for raw data
Doshi and his colleagues have called on public health authorities and drug manufacturers to release the raw data so that we can better understand who is most at risk of a serious adverse event.
“There’s no reason to think that these risks are going away and if it’s in the low-risk population, that’s very bad news, because low-risk people have much less to potentially gain from covid vaccines, so the side effect profile in such people has to be extremely low,” said Doshi, pointing out that Denmark now recommends against routine covid-19 vaccination for people under 50.
The FDA and the vaccine manufacturers have the raw ‘patient level’ data, but they have not released it and we’re now almost 2 years into the roll out of the product.
“They should immediately be warning people about this safety signal that we found, and they should immediately be replicating our analysis — the data are indicating there’s increased risk at a level that is much higher than has previously been realised,” said Doshi.
Throughout the pandemic, we’ve been told to “trust the science” but Doshi says, “How can one recommend responsibly that these products are based on science if the data are not available? Science is about sharing data. We’re in an era of open science, not secret science.”
Doshi and colleagues have penned an open letter to the CEOs of the vaccine companies asking for the raw data, but as yet, they have not received a reply.
See the full interview on mdr.de
I talked to Brook Jackson a couple of weeks ago. She had a lot of interesting things to say.
I am talking to Jen Younes (who is representing the New Civil Liberties Alliance in Missouri v Biden) this Friday. I am sure she’ll have a lot of interesting things to say as well.
Keep up the good fight.
Edward DowdReposted
Disclose.tv
@disclosetv
·
8h
JUST IN – CDC panel unanimously votes to add COVID-19 mRNA shots to the recommended childhood vaccine schedule in the United States.
Brook Jackson Retweeted
Kate
@KateTalksTruth
CDC is trying to quietly include a vote to add the mRNA C•19 vaccine to the annual childhood immunization schedule. This vote takes place in 2 days on October 19th. Here’s why this matters:
https://twitter.com/KateTalksTruth/status/1582112199635783680
Can you sue over a vaccine injury? – RKJr.
‘Freedom of expression was a victim of SARS-CoV-2, the virus of the covid19 pandemic.’ …
Juan Gérvas
@JuanGrvas
La libertad de expresión incluye la de mentir, decir idioteces, imbecilidades, necedades y tonterías, criticar a todo tipo de autoridad (académica, científica, civil, militar, política, religiosa, etc), discrepar de consensos y del pensamiento dominante…
https://www.actasanitaria.com/opinion/el-mirador/libertad-expresion-incluye-derecho-ser-imbecil-y-demostrarlo_2003182_102.html
The cost of the “daring”? To be included among the anti-systems, anti-vaccines, flat earthers, “opposites”, conspiranoics, etc.
Such experts on courageous resistance, ostracized, include Alan Cassels, Peter Doshi, David Healy, Tom Jefferson, Juan Erviti, Peter C. Gøtzsche, Iona Heath, Carl Heneghan, John Ioannidis, Juan Irigoyen, Paul Thacker, Claudina Michael-Teitelbaum, Sergio Minué, Joan Ramón Laporte, Vinay Prasad and Allyson Pollock.
In the words of Sergio Minué, regarding the lynching of Joan Ramón Laporte after his report on covid19 vaccines to the Parliament of Spain: “Joan Ramón Laporte is not the only example. The same lynching has suffered or suffers people like John Ioannidis, Peter Gotzche, Alyson Pollock, Carl Henegan, etc. Anyone who dares to question the “true religion.” The post-pandemic winter is really scary.”
“No, jaja”
https://www.heraldo.es/noticias/salud/2022/10/13/escandalo-pfizer-vacuna-covid-parlamento-europeo-1605529.html?utm_source=twitter.com&utm_medium=socialshare&utm_campaign=desktop
Are fact-checkers liars?
https://www.spectator.com.au/2022/10/are-fact-checkers-liars/
A similar thing happened later in the week when, during a European Union Parliamentary inquiry, Robert Roos asked Pfizer executive Janine Small if Pfizer had investigated their vaccine for preventing transmission before it was made available to the public. Her reply was the now infamous, ‘no’ and ‘we had to move at the speed of science’ including ‘doing everything at risk’.
This matters, because there are countless tweets, interviews, and public releases from Pfizer and associated entities all claiming that – to some extent or other – their vaccine significantly prevented transmission. It was a publicly stated fact that was used as the basis for widely criticised mandatory vaccination requirements, vaccine passports, and isolation orders for the unvaccinated.
Pfizer’s transmission claims caused the largest global abuse of human rights in living memory, so yes – it matters. The revelation that transmission remained a question mark is a public disaster for Pfizer and may lead to legal challenges.
Don’t worry, the Twitter fact-checkers are here. Within 24-hours the social media platform had a sticky-trend (something they pin to the sidebar) stating:
‘Recent claims about Pfizer’s Covid-19 vaccine trial and impact on transmission are misleading, fact-checkers report.’
It was followed by: ‘According to the Associated Press, Pfizer never claimed the clinical trial of their Covid-19 vaccine evaluated its effect on transmission. Reuters also reported that in clinical trials, vaccines were found to give recipients a high level of protection against severe disease – but effect on transmission, due to trial sizes, could not be immediately determined.’
That’s strange.
Pfizer’s official Twitter account posted, ‘The ability to vaccinate at speed to gain herd immunity and stop transmission is our highest priority.
There is a lot of work ahead, and our focus is on supporting points of vaccination, as that’s key to increasing the volume of people getting vaccinated every day.’
Both herd immunity and stopping transmission have turned out to be false for Covid.
You can watch the Pfizer CEO speaking at the World Economic Forum in Davos stating, ‘You vaccinate not only yourself, you vaccinate also to protect society, in particular to protect those that you love the most.’
Such a statement is predicated on preventing transmission.
In various tweets, Albert Bourla has said:
‘Although data shows that severe Covid is rare in children, widespread vaccination is a critical tool to help stop transmission. That’s why I’m excited we have begun dosing participants aged 5-11 in a global Phase 2/3 study of the Pfizer-BioNTech vaccine.’
‘Excited to share that updated analysis from our Phase 3 study with BioNTech also showed that our Covid-19 vaccine was 100% effective in preventing #Covid cases in South Africa. 100%!’
Not only was it stated in dozens of interviews, but the President of the United States said it, our chief health officer said it, the World Health Organisation and CDC said it. Where did these institutions and officials get their claim on preventing transmission, if not from the ‘experts’ that they say were cited?
The grand sleight of hand used in nearly every release to imply transmission is the phrase, ‘reduces symptomatic infection and therefore transmission’ allowing them to make statements like ‘90 per cent effective’ and have that used as a transmission argument. Fact-checkers can moan all they like, but we lived through the last two years and we know what was said.
And if we are so interested in fact-checking why, when it became obvious in the earliest months of the vaccine roll-out, wasn’t the claim rescinded (rather than repeated) by Pfizer and others as Covid spread through fully-vaccinated communities?
There were no fact-checkers rushing to correct the public record when the claims of politicians, health authorities, and Big Pharma were proven false – in fact, it was the fact-checkers who saw to it that the people speaking the truth were banned, ridiculed, or told they were ‘missing context’.
Pfizer CEO on COVID booster uptake: ‘Complacency will get in the way’
Mon, October 17, 2022 at 8:12 PM
https://finance.yahoo.com/video/pfizer-ceo-covid-booster-uptake-191221899.html
Pfizer CEO Albert Bourla joins Yahoo Finance’s All Markets Summit, saying that while we can adapt vaccines quickly, complacency will become a hurdle to controlling the virus.
Video Transcript
We are trying to move, of course, past COVID, but it’s not quite done with us yet. You yourself had COVID a couple of times, I believe, in the August time frame. And I wonder if we’re ever going to get to the point where vaccines can actually prevent COVID and its variants entirely. Is that the end goal? Is it a realistic goal?
ALBERT BOURLA: First of all, I had COVID once in August, and one in October. And the second time was in the UK. I think that the goal is to bring vaccines so that they can last a year.
I think that will simplify things, because I believe that people will not be that diligent to do the vaccinations as they are tired of making too many vaccines. And they want stability.
But if we have a yearly vaccine, which is something that people are used to, like flu, for example, this is something that will take a significant amount of people to be able to get it.
And yes, I think with the right vaccines, we can prevent from infections to hospitalisations to deaths and severe diseases. But of course, the vaccine has shown that death and hospitalization, the prevention is very high. When it comes to infections, so the bar is a little bit lower.
– So it’s more comparable to a flu than, say, a polio, for example, something that you’re just trying to eradicate?
ALBERT BOURLA: Or unfortunately, this virus is very nasty and makes a lot of variations, and [? insists. ?] So I think– although, nobody knows. Most scientists are in agreement that for the years to come the virus will be around us. But we are lucky, because we have a vaccine that can adapt. As much as the virus [? stops, ?] the new technologies allow us, the vaccines, to very quickly follow, and have a vaccine that is very effective against the current virus.
– And indeed you all have just introduced a booster that is targeted at one variant of that virus, Omicron specifically. Do you envision it where everyone, ideally, will get a booster every year, or will it just be recommended for certain portions of the population?
ALBERT BOURLA: I think the health authorities will make those recommendations, while they see what is the severity of the strains that are available. But in many case, I do not expect that people will comply with these recommendations. If they did, maybe in the first months of the pandemic that people were really scared. So [INAUDIBLE] will be getting their way, so I see that the volumes of people that will be getting the vaccine will be less.
Pfizer CEO talks COVID vaccines, vaccine pricing, mRNA technology, and the company’s future
https://www.youtube.com/watch?v=m_B05bg4K30
“No, jaja” …
“The cost of the “daring”?
Juan Gérvas
@JuanGrvas
Resulta q todo el mundo sabía q la vacuna covid19 no reduce ni los contagios ni la transmisión Pero todo el mundo se ha pasado casi dos años difundiendo lo contrario para forzar la vacunación con chantaje emocional Mentira y cinismo al servicio de Pfizer
The Ministry of Health of Spain lies when asking to vaccinate covid19 (and flu) “to protect others”
Juan Gérvas
https://www.actasanitaria.com/opinion/el-mirador/miente-ministerio-sanidad-espana-pedir-se-vacune-covid19-y-gripe-para-proteger-demas_2003558_102.html
This “protecting others” is false and we have always known it, since the summer of 2020, since the development of a Covid-19 vaccine that did not modify the immunity of the mucous membranes or the contagious capacity of the virus that produces covid-19 (SARS-CoV-2). Without mucosal immunity, the vaccinated can be a transmitter of viruses and herd immunity does not occur. Therefore, finally, in the summer of 2022, the Centers for Diseases Control and Prevention (CDC) of the United States established new recommendations making it clear that vaccinated and unvaccinated covid19 should not be discriminated against because they were infected and spread in a similar way. Of course, when the “protect others” narrative fails, new ones are invented as long as the sales machine keeps running.
In fact, in Spain no analysis of the response to the Covid-19 pandemic has been made, but it can be joined to the global set of public health failure that has led to almost 12 million avoidable deaths, only here with special opacity and impunity. We have social killers for leaders, as the British Medical Journal highlighted.
Patrick D Hahn
@PatrickDHahn
“It’s a great reset we can all get behind”
https://catherinecarrigan.com/do-antidepressants-increase-suicide-and-violence/
Patrick D Hahn Do Antidepressants Increase Suicide and Violence?
Thebmj is mostly free to read. Anybody can make a (free)rapid response to an article or to another relevant response
‘Rapid responses are electronic comments to the editor. They enable our users to debate issues raised in articles published on bmj.com.’
Regulatory judgments for toxicity signals of medicinal products: in search of accountability.
Re: Radical transparency in post-market oversight of medicine safety Barbara Mintzes, Colleen Fuller. 379:doi 10.1136/bmj.o2275
Dear Editor ( r.r. by Alain Braillon)
IMHO, the call for “radical transparency” about available evidence of regulatory judgments based upon the article analyzing the “safety signals” identified within the US Food and Drug Administration’s Adverse Event Reporting System” is a cul-de-sac.(1,2)
Indeed, the lack of concordance of regulatory agency judgments about drug toxicity issues among 4 similar countries (Australia, Canada, the United States, and the United Kingdom) has already evidenced that judgments are not reliable and fly in the face of common sense.(3)
Further, the issue is a systemic one. Poor regulatory judgments for toxicity signals are the tip of an iceberg:
Certainly, finding a prudent middle ground to protect patient interests represents an immense tension for drug regulators. However, the system is out of control, having been on a very slippery slope for a long time: going faster and faster for approval, replacing evidence by expectation, while remaining too slow for withdrawal,(4) the latter having not been improved despite the rise in big data technology. E.g., since 2015 the French independent drug bulletin “Prescrire” has been blowing in the wind with its yearly publication of the list of “drugs to avoid” — drugs still on the market in the European Union or in France since 2010 despite being more harmful than beneficial or having been superseded by drugs with a better harm-benefit balance — among a hundred drugs, market withdrawals can be counted on the fingers of a mechanical fitter and several drugs remain among the most prescribed worldwide as citalopram, the 31st most commonly prescribed medication in the United States. Accordingly, faculty members, professional colleges and prescribers are also accountable for this shipwreck.
Last, semantics illustrates that the issue is a deep one, through character flaws or mindsets that are far more complex than conflicts of interests. When we prescribe, benefits are almost for sure while harms are at worst only a “risk”.(6) Similarly, Mintzes and Fuller as Dhodapkar and colleagues (1,2) only used the term “safety signals” while the signals are about toxicity!