In 2008-2009, 7 young women died in a HPV vaccine trial in India. There was a backlash against the clinical trial industry. Quite apart from Pharma trials, the National Institutes of Health (NIH) had 70 ongoing trials that were abandoned.
It was clear, Indian investigators had to be taught how to assess awkward events properly.
Barbara Bierer, a Haematologist, and founder of MRCT travelled to India in 2014 to help the new Indian Society for Clinical Research (ISCR) with causality assessment. ISCR had been set up by Pfizer in 2010 and company support made the ISCR journal open access.
Causality assessment refers to the ways to assess possible links between a drug or vaccine and harms happening in company trials or other studies, or just clinical practice.
At this MRCT workshop investigators were encouraged to distinguish between adverse events and adverse reactions and to establish if:
- there were similar reports previously linking the drug or vaccine to an event
- there were similar reports in the label of related drugs or vaccines
- the event appeared in the investigator brochure
- the event was consistent with the pharmacological mode of action of the drug
- the event was consistent with the pharmacokinetic profile of the drug
- the event was consistent with peak plasma or overall concentration of the drug
- the event might be consistent with the first sign of a latent illness
- whether there were concomitant drugs
- whether there were concomitant conditions
- whether anything else was happening at the time of the event
- if none of the above consider that the event might have happened but be unrelated to the drug.
In the world of company trials, nothing ever steers an investigator toward linking a harm with a treatment. The entire trial process hinges on a mantra that trials rather than an assessment of individual cases by a clinician offer true cause and effect information. Unless an event has been demonstrated to happen to a statistically significant extent in a controlled trial there is no good evidence that the drug or vaccine has caused it.
WHO guidance on establishing causality for adverse events in vaccine trials now goes even further and states that every effort must be made to link an event following a vaccine to factors other than the vaccine. See Bellavita and Pulliyel.
The result – death after death from myocarditis, stroke or other cause, in Pfizer’s and other Covid vaccine trials that appear in the paperwork companies send to FDA and EMA feature as investigator codes as not-related. FDA reviewers close to universally agree with the ‘investigator’,
If anyone now rooting through any vaccine trials finds a death or serious injury that an investigator or regulator has linked to the vaccine, please send us news of where we can view this unicorn.
Harmatology
Wondering about Bierer, who had no background in adverse events or causality assessment, I texted a Haematology friend to ask if she had ever heard of BB. The predictive text on my phone converted Haem to Harm and a new science was born .
Circe Surrounded by Porkers © Nina Otulakowski June 2022
Harmatology is the science centered on making the harms of treatments disappear. It is key to transformating RCTs into a vehicle to provide a smooth assay system for drug licensing.
Harmatologists convert valid and criticial information about vaccines and drugs into anecdotes and misinformation. They transform the truth we need for our journey through life’s perils, the forced navigations between a Scylla and Charybdis, into ‘porkers’ or ‘porkies’- a porker is London slang for a lie – because it rhymes with the pie in pork-pie.
Porkers conjures up Circe, who famously magicked Odysseus’ men into pigs.
The precision of Harmatology 1.0 processes to ensure efficacy and eliminate harms developed steadily from the 1980s to the point where by 2000 companies could confidently claim that there is no evidence of any harms on any of their drugs.
We have moved on Harmatology 2.0, glimpses of which you can get below.
Step 1:
Embrace Randomized Controlled Trials (RCTs). Without much gaming, RCTs ensure company interests in seeing harms disappear are realized. RCTs necessarily focus on a primary endpoint and hypnotized by this the 99 other effects of a drug are gathered so haphazardly that they disappear even when these effects are immediate and all but universal like the sexual side effects of antidepressants. Mission Accomplished.
In the very first RCT of streptomycin in 1948, deafness and tolerance were missed. And in a 1960 RCT, run by Louis Lasagna, thalidomide showed up as effective and harmless. If only there had been more RCTs then to counter all that misinformation about that great drug. Lasagna was quite a visionary when he pushed to have RCTs incorporated into the 1962 Food and Drugs Act.
Step 2:
Healthy volunteer trials, or Phase one trials as they are called, offer the perfect opportunity to see the hazards your drug or vaccine causes, leaving you time to think, for example, about how to just not collect any information on sexual function in an antidepressant trial or any indications of dependence. These trials are never published so no-one will ever see what has disappeared. Mission ongoing.
Step 3:
Having eliminated anything occurring with any degree of frequency, insist that only effects occurring to a statistically significant extent in trials are viewed as having been established as linked to a treatment. Mission Accomplished.
Given that statistics strictly speaking should only be applied to a primary outcome, this gets rid of any possibility that any event other than the primary outcome can become statistically significant. Statistics can only be applied meaningfully to events that have been measured precisely. Nothing in a clinical trial, other than the primary outcome, is measured precisely.
Step 4:
Some people found it hard to believe when we said our drugs have no adverse events, as in Harmatology 1.0. Vatican 2 (Harmatology 2.0) has come to the rescue.
The vaccine trials have let us roll-out a development we’ve been working on – prepopulated lists of effects other than the primary outcome. These lists of immediate vaccine side effects like a sore arm are delivered on electronic devices for individuals in trials to complete in the comfort of their own homes – see Virtual Research.
The fact that they are collected on all individuals in the trial means that statistics can be applied to them. As a result, it can be claimed that vaccines give rise and only give rise to headaches, mild fevers, aches and pain – all the features of vaccine reactogenicity. The Apps have no space for the registration of other effects. If these are reported in letters or emails, they can be declared reported, they can be reported as expected reports, without conceding evidence for a linkage. Mission Accomplished.
Step 5:
Train investigators in both developing and developed world settings on the lines of the training offered by Bierer above. Mission Accomplished.
Step 6:
Introduce coding dictionnaries. These let us code suicides as nausea, emotional lability or burns. No one spots that they are the first line of authorship. Once the coding is in place, the paper writes itself. Mission Accomplished.
No paper appearing in any medical journal has ever in its methods section dealt with coding bar one – Study 329.
Step 7:
Brand careful analyses of cases that appear to establish that a drug or vaccine has on a balance of probabilities caused a harm as porkers (anecdotes, misinformation). Do this to the extent that journals like the BMJ or NEJM that used to publish case reports stop doing so. Do this with the stick of legal actions for publishing porkers harmful to your company’s interests and with the truffle of large amounts of money for reprints of published RCTs and meta-analyses of RCTs. Mission Accomplished.
Step 8:
Abolish Drugs Bulletins, which mention the harms of treatments, or make their lives harder by for instance requiring doctors to buy them, which the skinflints won’t rather than have them made available for free by health services. Mission Accomplished.
Step 9:
Get legal systems to accept that the only reliable information about drugs comes from clinical trials. When doctors report a harm, who knows how reliable that information is whereas with harms in RCTs we can tell the courts what the margin of error is. We can help courts to get away from prejudiced experts and offer information that every expert has to adopt. Mission still in the Balance.
Step 10:
Create Evidence-Based-Medicine. Mission Accomplished in 1991 by Eli Lilly and the BMJ working in conjunction. See Vampire Medicine.
Step 11:
Relentlessly exhort doctors to practice in accordance with the evidence. Begun in 1965 and continuing.
Step 12:
Outsource the running of Drug Trials to Contract Research Organizations (CROs) who shuttle between investigation centers and return the data from each site to a central repository linked to the CRO and probably offshore. Mission Accomplished.
Where before 1990, all of the assay data was in the lead investigator’s filling cabinet, after 1990 it was sequestered – goodness only knows where.
Step 13:
Embrace Guidelines. We don’t have to write them. The guidelines are based on the published literature, which is ghostwritten, and the bulk of which comes from our ‘trials’, with no access to the data. The guidelines write themselves and health services pay academics to convene and put their names to these standards that promote our drugs. Its a great business model and the greatest concentration of Fake literature on earth. Mission Accomplished.
Relentlessly exhort doctors to practice in accordance with Standards of Care, a.k.a. Guidelines.
Step 14:
Ensure medical trainees in all specialties learn the standards of care. Make it so that they need to parrot these to pass their exams and qualify in the specialty of their choosing. Mission Accomplished.
Even now few young doctors can imagine how a drug or vaccine could cause a problem. If a young aspiring medical student wants to engage with the ‘customer’ enourage them to think about something else – like hairdressing.
Step 15:
Ensure that Patients with Rare Diseases have a place in any forums where access to assay data is being discussed. None of these patient advocates will support access to assay data because the risks of people with a rare disease then being identified is too great. 6ission Accomplished.
Step 15:
One of our greatest weapons has been informed consent forms. They began as a way to inform people they were taking part in an experiment on one of our drugs. We turned them into something that tells people we will never let anyone see their data – not even regulators. Mission Accomplished.
This sounds good to those simple volunteers who think they are participating in a scientific exercise that will advance the health of their families, friends and communities but in fact will create a state of legal jeopardy for their family, friends and community who will not be able to get access to the evidence that our drug caused harms in the assays in which it was tested.
Step 17:
The data are the figures and the boxes ticked, right? Stick to that.
Never admit that people are the data. When we remove their names and contact details, we can invent figures and tick whatever boxes we want. No-one can ever find out that we have airbrushed problems out of existence or created non-existent trial participants
In our trials people come out apparently cured of severe illnesses like depression but commit suicide a few days later or have their sex lives wiped out forever and wish they had never had the drug or become dependent on the drug and are still on it a decade later. We do not want anyone to be able to contact these people. Mission still in the Balance.
Step 18:
Ensure people’s names figure nowhere. Named people willing to come into court and talk about their injuries and be cross-examined are like garlic or crucifixes to us. Mission Accomplished.
Step 19:
Fairly soon all trials will be Virtual. People will participate from their homes on electronic media and we will be able to monitor what is going on in the background and discontinue them from the trial before anything goes seriously wrong. See Virtual Research. Mission in Progess and looks unstoppable.
Step 20:
The Virtual Trial ‘data’ will feed straight through to Artificial Intelligence A.I. enabled medical writing systems who will report the results of the trials without a human hand going near anything. Pure objectivity. The finished article will appear in the New England J of Medicine two weeks after the trial has finished. See Albert Bourla’s Mooning. Mission in Progress – looks unstoppable.
In the meantime, we have Eric and a few others dotted about in all major journals. Every medical journal should have one. Eric rejects any request for access to the data, and all reports of an adverse event – New England Journal.
Step 21:
One of the worries is ensuring that doctors do not spot that if harms disappear they too will disappear – replaced by nurses with both soon replaced by robots – see Caught in the Firing Line. At the moment, with their snouts in the trough they show no signs of noticing what has happened.
Step 22:
American English rules. Make sure we keep spelling it Hematology.
Step 23:
Women-wash. Step up Barbara, Rebecca, Liz and others.
Circe
Circe is one of the more impressive women in Greek mythology. The way she dealt with smitten men and women rivals was impressive. One king was turned into a woodpecker and one rival was turned into Scylla who is mentioned above.
A 2020 book by Madeleine Miller that has had rave reviews seeks to rehabilitate Circe and make her a twenty-first century icon for women.
It will take a really strong woman or group of women to restore truth and dismantle Harmatology 1.0 and 2.0. But women mobilized by harms to their children, parents or friends (partners are a different matter) are perhaps the most powerful force on earth and capable of creating Harmatology 3.0 – the science needed to cut through all the misinformation and recognize harms.
Footnote
Without intervention, ‘superpigs’ could soon invade Alberta cities, researcher warns
This is wonderfully apposite; Alberta has been the Canadian province most concerned about Covid and Vaccine related porkers.
With Respect, Prof Healy, may I suggest a few additions to your schedule?
I am thinking
6(a) Stick to fuzzy dictionaries of adverse events. Examples: Allow “Death” as well as “Cardiac Death”, “Jaundice” as well as “Neonatal Jaundice” as well as “Hyperbilirubinemia”, “Forearm Fracture” as well as “Fracture Forearm” This helps reduce the number of subjects with specified adverse events!
13(a) Mercilessly fund academic departments of “Translational Medicine” – nothing to do with those of us whose mother tongue is not English – these enterprises ensure that ghostly guidelines quickly get turned into clinical practice.
13(b) For wow-factor make sure that the term “Real World Medicine” is used in every clinical trial write up.
There exists a medical word Hamartoma. Hamartomas are, by definition, benign, slow-growing or self-limiting. Which is a shame because otherwise you could apply that term to those medical scientists who make the harms of treatments disappear.
Even benign Meningiomas can kill if they get so big they compromise other vital functions.
In this case the Harmatoma is so big that it is close to killing us all.
Another haematological way to view it is we have a Clinical Immundodeficiency Virus (CIV) – the clinical immune system is not working properly to detect and eliminate viruses giving us all an Acquired Immune Deficiency Syndrome. In this case, like the ticks who transmit Lyme disease, doctors have become the vectors of transmission by brushing too closely up against a fake literature and tolerating a lack of access to trial data. The editorial staff of journals (the ‘best’ journals) have become superspreading ticks – black-legged ticks.
D
“Today pigs were flying.” …..
Does a Leopard really Change it’s Spots?
“Truth is stranger than fiction”
“……it’s just inconvenient for the audit trail if they do……”
The dynamics of ‘D’
https://www.youtube.com/watch?v=oiePiQ_U8e4&t=1s
Pigs Fly As Open Science Comes To Big Pharma
https://www.forbes.com/sites/harlankrumholz/2012/10/11/pigs-fly-as-open-science-comes-to-big-pharma/?sh=1d74b50b7c5b
Just last week, I wrote in these pages that, “I see a day when the companies are competing on science, not marketing – and open science and data sharing are part of their business model.” To be honest, I was not sure when that day would arrive. But today seems to be it – at least for GlaxoSmithKline (GSK), the world’s fifth largest pharmaceutical company. Today is a day to celebrate GSKs decision to share patient-level data from the clinical trials of its approved medicines and discontinued investigational medicines. The press release states that GSK has fundamentally changed its business model to become more open to sharing intellectual property and knowledge. If the company makes good on its pledge, it will change the future of medical research.
GSKs decision to share data occurs within an industry that has consistently held back information that has relevance to understanding the risks and benefits of its products. Patients face decisions every day and their physicians have been denied access to the totality of evidence about products being sold. Review articles, textbook chapters, and guidelines are all based on only a fraction of the evidence that has been produced in the study of these products. And there is plenty of evidence that the data behind closed doors can have an important effect on the assessment of a product’s risks and benefits – sometimes providing more support and sometimes less. We have allowed this system to persist in deference to the fact that the companies own their data and despite the fact that such shielding of information from the public was not in patients’ best interests.
GSK has not always considered sharing to be a good idea. It was forced by litigation to share summary data from its trials and even then did not promote access. It was that forced sharing that led to the recognition that Avandia (rosiglitazone), the diabetes drug, likely increases the risk of heart attacks. For actions in that period, GSK incurred criminal changes and a $3 billion fine in what has been described as the largest case of healthcare fraud in U.S. history.
Andrew Witty, CEO of GSK, has apologized for past behavior – a virtually unprecedented move in the pharmaceutical industry. Moreover, he stated, “We are deeply committed to doing everything we can to live up to and exceed the expectations of those we work with and serve. Since I became CEO, we have had a clear priority to ingrain a culture of putting patients first, acting transparently, respecting people inside and outside the organization and displaying integrity in everything we do.”
Many were skeptical about whether there would really be a change. But today, anything seems possible as Witty is making good on his assertion that GSK is entering a new era in its history .
Several aspects of the announcement are worth noting. GSK is making its trial database available to researchers in an attempt to steer the use toward scientific purposes. It is not merely providing summary data, but is sharing patient-level data, which will support a broader array of research and is a higher level of transparency. This issue will seem like a nuance to some readers, but those in the field of medical research recognize it as a major step forward and a signal that the company is serious about promoting open science. I hope that such disclosure is accompanied by a willingness to share protocols and other key information and data – but this step alone is remarkable.
My hope now is that it becomes increasingly untenable for other companies to resist the call to join the world of open science and data sharing. Medtronic, in a project with Yale that I lead, preceded the GSK move by sharing data on an important product, bone morphogenic protein-2, which has revenues approaching a billion dollars. Although many in industry expressed private support, publicly no other company indicated a willingness to follow the example. GSK has now upped the ante.
I think we will look back on today as a watershed moment – predicated on GSK truly embracing the spirit of what they have espoused. Those of us who have been calling for industry leadership had hoped that such sharing would not require legislation, regulation or litigation – but that the companies would see the wisdom of the approach. We hoped that they would move first and, as a result, begin a process of restoring the public’s trust in them. Academics need to catch up to GSK and also embrace the wisdom of sharing data – in many cases their record is currently no better than industry’s.
Other companies should hear the clock ticking. Witty said clearly, “…the complexity of the science and the scale of the challenge mean that we cannot solve these problems alone. We need to take a different approach – one focused on partnership, collaboration and openness.” Until other companies follow suit, they will be at a disadvantage scientifically. I hope they realize that soon.
Today pigs were flying. The improbable became so, and, if GSK is true to what they have promised, society will be so much better for it.
“Today pigs were flying.” …..
Annie
This is a fabulous development on the theme
D
Just for those of you who aren’t aware, this is Ben Goldacre talking about the foundation of AllTrials, which was outlined in last weeks Mark, and Barb, and Eric and Carole post.
D
I think I saw the pigs flying over Whitty’s house today. They crapped on it,
Is it true by the way that there is a proposal to set up a royal college of harmatologists? Maybe with prince William as patron as he is so impressed with the UK pharma industry (see his silly pompous speech at the UK jubilee).
This used to be the stuff of futuristic SciFi .-
Rebel News
WATCH: The Canadian psyop — an exercise in behaviour modification techniques
Was the federal government involved in ‘shaping’ the beliefs and actions of Canadians during COVID-19?
By Tamara Ugolini June 06, 2022
https://www.rebelnews.com/watch_the_canadian_psyop_an_exercise_in_behavior_modification_techniques#:~:text=WATCH%3A%20The%20Canadian,June%2006%2C%202022
“It is nice to feel trusted and I am grateful for that.
https://www.bbc.co.uk/news/uk-61723492
Sir Patrick also praised the “most amazing scientists and experts” who made sure the public was given up-to-date factual information during the pandemic.
“It has been one of those experiences where you realise the importance of other people, humanity and the goodwill, hard work, passion and expertise,” he said.
“It is nice to feel trusted and I am grateful for that.
“What I have tried to do and what others have tried to do is to make sure we are as honest and straightforward as possible about how we saw the situation at any given moment in the pandemic and to be as realistic as possible – both in terms of treatments and vaccines coming along but also on what the course of the pandemic was.”
The Chutzpah – upgraded
https://www.dailymail.co.uk/health/article-10892679/Governments-chief-scientific-adviser-Sir-Patrick-Vallance-receives-honour-Prince-William.html
2013-06-14 — The RIAT team sends an email to GSK, Sir Andrew Witty (CEO) and Patrick Vallance (President of Pharmaceutical R&D), notifying them of the RIAT article publication and requesting that if they plan to restore any old GSK trials, they respond as soon as possible.
https://study329.org/correspondence-with-gsk/
“We look forward to your participation in helping correct the scientific record.” …
Nature
08 June 2022
Monkeypox vaccination begins — can the global outbreaks be contained?
Some countries have begun to use smallpox vaccines to protect people exposed to the monkeypox virus.
Max Kozlov
As global monkeypox cases continue to rise, public-health officials and researchers are questioning whether the current outbreaks can be contained. The World Health Organization has said that the situation is unlikely to escalate into a full-blown pandemic. But more than 1,000 people have now been confirmed to have been infected with the virus in nearly 30 countries where outbreaks do not usually occur (see ‘Unusual spread’).
Countries including Canada, the United Kingdom and the United States have begun implementing a strategy called ‘ring vaccination’ to try to halt the spread of the virus. This involves administering smallpox vaccines — which are thought to be effective against monkeypox because the viruses are related — to people who are known to have been exposed through close contact with an infected person.
But there are unknowns and challenges that come with using this strategy for monkeypox, says Natalie Dean, a biostatistician at Emory University in Atlanta, Georgia. Although the vaccines are considered to be safe and effective for use in people with smallpox infection,
the vaccines have had limited testing against monkeypox. The strategy also relies on highly rigorous contact tracing, which might not be implemented in every country,
and people must also agree to be inoculated with vaccines that can carry rare, but serious, side effects.
Ring vaccination can be a powerful tool, Dean says, but to be effective it needs to be used early — while case numbers are still manageable. “As the numbers crop up and you think about the number of contacts each individual has, the logistics just become more complicated,”
she says, adding that there is a narrowing window of opportunity to prevent the virus from gaining a more permanent foothold in human or animal populations in countries where the global outbreaks are occurring.
Some countries maintain stockpiles of smallpox vaccines, mainly because public-health officials have been worried that smallpox — a disease eradicated more than 40 years ago that can kill about 30% of people infected — could still be accidentally released from laboratories where samples are kept, or could be weaponized.
These smallpox vaccines are thought to be about 85% effective against monkeypox infection, according to the CDC and the WHO, which both cite “past data from Africa”, where outbreaks have occurred for decades, to support their assessments. But the highly-cited figure is “shaky”, Dean cautions.
scientists think the newer vaccines would have a similar efficacy against monkeypox.
There is also compelling evidence from animal studies that they would work against monkeypox, but they haven’t been directly tested against that disease in people, Dean says.
Unlike how countries responded to COVID-19, public-health officials aren’t currently mulling a mass-vaccination campaign for monkeypox. That’s because the side effects of the second-generation smallpox vaccines, which have been stockpiled by countries at a much higher level than third-generation versions, prevent them from being given to children, individuals who are pregnant, those who are immunocompromised or those with a spectrum of skin conditions that fall under the classification of ‘eczema’.
Third-generation vaccines, which fewer countries have access to, have fewer side effects and could therefore be given to a greater proportion of people.
At the moment, the risk posed by monkeypox to the general public isn’t high enough to warrant mass-vaccination, given the side effects and availability issues, says Daniel Bausch, the director of emerging threats and global health security at the Foundation for Innovative New Diagnostics in Geneva, Switzerland. But if the virus starts spreading in vulnerable populations such as pregnant people or children, or if it turns out to have a higher fatality rate than expected, that risk-benefit calculation could change.
Limited data
Usually, monkeypox causes fever, swollen lymph nodes and sometimes-painful fluid-filled lesions that form on a person’s skin. Left untreated, the infection can clear in a few weeks — especially for those with access to health care.
Bavarian Nordic, a biotechnology firm based in Hellerup, Denmark, that created the third-generation smallpox vaccine MVA-BN, said on 30 May that it has been taking orders in response to global demand. If countries had a larger stockpile of third-generation smallpox vaccines, Raina MacIntyre, an infectious-diseases epidemiologist at the University of New South Wales in Sydney, Australia, says it would be a “no-brainer” to use them for a robust ring vaccination campaign against monkeypox.
And getting people to take vaccines could be difficult. As of 24 May, only 15 of 107 community contacts and 169 of 245 healthcare workers in the United Kingdom opted to take an MVA-BN vaccine after possible monkeypox exposure during the current outbreaks, according to a report in Eurosurveillance2.
doi: https://doi.org/10.1038/d41586-022-01587-1
Monkeypox now recorded here since week 20 page 15, Covid 19 has been removed
https://www.gov.uk/government/publications/notifiable-diseases-weekly-reports-for-2022
Karen Kingston thinks Moneypox is a cover up for this
https://onlinelibrary.wiley.com/doi/10.1111/dth.15595
https://gettr.com/post/p1d2f1nc497
doxycycline for Covid 19 Dr prescribes to 2000 plus – wonder how many became suicidal
https://drtesslawrie.substack.com/p/how-did-this-under-resourced-country?utm_source=%2Fprofile%2F80297209-dr-tess-lawrie-mbbch-phd&utm_medium=reader2&s=r
“Dr Alam prescribed each student a single dose of ivermectin with doxycycline. This time, recovery took just four days for most, five days tops.”
I thought this video was just but here it.
An American nurse talks about what she witnessed in an American hospital during the first year of the pandemic.
https://youtu.be/UIDsKdeFOmQ
😔
I had to share this:
17 June 2022
Dear Friends, Sorry to Announce a Genocide: Dr. Naomi Wolf on the Pfizer “Confidential Report”
It’s Really True: They Know they are Killing the Babies
By Dr. Naomi Wolf
https://www.globalresearch.ca/latest-news-and-top-stories
😠
“Correction”:
I thought this video was lost but here it is.
An American nurse talks about what she witnessed in an American hospital during the first year of the pandemic. https://youtu.be/UIDsKdeFOmQ 😔
“Embrace Randomized Controlled Trials (RCTs). Without much gaming, RCTs ensure company interests in seeing harms disappear are realized.”
Oh, there are sooo many ways that RCTs can be of benefit. I can think of three others off the top of my head.
RCTs can be used to assure that benefits from competitors are hidden. “No statistical evidence of benefit” after an underpowered trial was run. Think of the Boulware trial of hydroxychloroquine.
RCTs can be ghostwritten by a pharma employee with a gloss of professional leaders in the authors section.
RCTs can be run to give competitive treatment too late to be of benefit. Think of the RECOVERY trial arm of hydroxychloroquine.
Re Annie’s comment above – Patrick Vallance ‘It’s nice to be trusted’
From
I Am the Alpha and the Omicron
January, 5, 2022 | 52 Comments
Reply
susanne says:
January 13, 2022 at 3:13 am
from The Conservative Woman
COVID-19Cover-up, deception and our chief Covid advisers
By
Neville Hodgkinson
–
January 13, 2022
MORE evidence of a damaging cover-up by top British and American scientists of the laboratory origin of the Covid-19 virus has emerged in emails released in the US under Freedom of Information laws.
Sir Patrick Vallance, the UK Government’s chief scientific adviser, and Sir Jeremy Farrar, a former senior member of the advisory body Sage and boss of the powerful Wellcome Trust research fund, are among those mentioned.
This Video May Soon Be Banned. Watch Before It’s Deleted
The emails show that as far back as February 2, 2020, Farrar knew the SARS-CoV-2 virus was unlikely to have arisen naturally. He suggested to Dr Anthony Fauci, America’s ‘Covid czar’, that it may have evolved ‘accidentally’ from a SARS-like virus in human tissue in the Wuhan Institute of Virology in China.
But he was told by Dr Francis Collins, then director of the US National Institutes of Health: ‘I share your view that a swift convening of experts in a confidence-inspiring framework is needed or the voicers of conspiracy will quickly dominate, doing great potential harm to science and international harmony.’ Dutch virologist Dr Ron Fouchier (who has subsequently claimed that the Covid pandemic proves the necessity for animal research) wrote that ‘further debate would do unnecessary harm to science in general and science in China in particular’.
The following month Farrar was among 27 scientists who signed a letter published by the Lancet dismissing as ‘conspiracy theories’ claims that Covid-19 had a laboratory origin. The signatories included two other Wellcome scientists.
Farrar has subsequently continued to claim that ‘the best scientific evidence available’ is that the virus crossed from animals to humans.
The Lancet letter set back by more than a year official discussion around the lab origin of the pandemic – vital information for governments globally in deciding how best to respond.
Farrar was also involved in initiating a World Health Organisation inquiry, subsequently dismissed as a ‘whitewash’, which cleared the Wuhan lab of involvement. He wrote to Collins and Fauci on February 5, 2020:
Francis and Tony
Couple of things
*I spoke again with WHO this morning. I believe they have listened and acted. Let me know if you agree.
At the WHO meeting next week they will set up the Group who will ‘look at the origins and evolution of 2019n-Cov’
They have asked for names to sit on that Group – please do send any names
We can have a call this week with a core group of that to frame the work of the Group including – if you could join?
I think this puts it under the umbrella of WHO, with action this week and into next
With names to be put forward into the Group from us and pressure on this group from you and our teams next week.
*The team will update the draft today and I will forward immediately – they will add further comments on the glycans
Does that sound reasonable to you?
Jeremy
(‘Glycans’ is a reference to glycosylation, a key feature of the genetic modification that made a bat virus capable of infecting human cells.)
The email followed an urgent February 1 teleconference, involving both Vallance and Farrar, called to discuss how to respond after WHO declared Covid a global health emergency on the previous day.
Farrar issued a note warning that ‘information and discussion is shared in total confidence and not to be shared until agreement on next steps’. It went to Fauci and Vallance, copied to six others including Paul Schreier, chief operating officer at Wellcome.
The call centred on a document entitled ‘Coronavirus sequence comparison’ and was triggered by a note from immunologist Kristian Anderson of the Scripps Research Institute in California saying that the virus had features which might make it look as if it had been genetically engineered.
In addition, Fauci drew attention to a November 2015 article written by Ralph Baric, an immunologist based in the US and long-term recipient of funds from Fauci’s National Institute of Allergy and Infectious Diseases (NIAID). The paper was described in the email as ‘Baric, Shi et al – Nature Medicine – SARS gain of function’. Shi Zhengli is the scientist who became known as ‘batwoman’ through her research into bat coronaviruses at the Wuhan Institute of Virology.
‘Gain of function’ is the term used to describe laboratory modification of viruses to alter their transmissibility and infectivity. The US government banned such research in 2014 because of concerns about the dangers it could present to human health, such as we have seen with SARS-CoV-2.
Fauci is alleged to have circumvented the ban by paying for work initiated in America to continue at the Wuhan institute.
The case against him was further strengthened this week by the release of documents showing that in 2018 a US Defense Department agency refused to fund the same research on safety grounds. The documents also reveal concern over the suppression of potential treatments such as ivermectin and hydroxychloroquine, and about the mRNA vaccines.
The revelations of cover-up and deception at the highest level call into question whether the UK Government should continue to take advice from Farrar and Vallance over the handling of the pandemic response.
If it had been known that research by US and Chinese scientists gave rise to the pandemic, would governments worldwide have put their trust in the lockdown and mass vaccination policies that have proved so damaging? Especially when promoted by scientists such as Fauci who were among those funding the research.
Farrar, who was a member of Sage from the start of the pandemic, left the advisory body in October, saying he wanted to devote more time to the Wellcome Trust.
As Paula Jardine has described in TCW Defending Freedom, even as the Wuhan lockdown was being imposed by the Chinese government as far back as January 23, 2020, Farrar appeared at a press conference convened at the World Economic Forum in Davos by the Coalition for Epidemic Preparedness Innovations (CEPI), promoting the idea that dramatic interventions of social control might be the only way to control a pandemic pending the development of a vaccine.
Vallance, the UK’s chief scientific adviser since March 2018, is former president of research and development at the pharmaceutical giant GlaxoSmith Kline (GSK). It was announced last June that he is to oversee the new National Science and Technology Council ‘to put science and technology right at the heart of policymaking and strengthen the way we work across government to reinforce the position of the UK as a science superpower’.
Reply
What are they hiding?
At the start of Covid many scientists believed it likely leaked from Wuhan lab – until a conference call with Patrick Vallance changed their minds. We asked for his emails about the call. This is what we got . . .
https://www.dailymail.co.uk/news/article-10052689/Government-condemned-refusing-release-details-key-email-conversations-Covid-origins.html
The Government has been condemned after refusing to release details of key email conversations involving leading scientists over the origins of Covid-19.
This newspaper used Freedom of Information rules to obtain a cache of 32 emails about a secretive teleconference between British and American health officials held early in the pandemic.
But officials blacked out almost every word before releasing the crucial documents.
Before this discussion, several of the world’s most influential experts believed the new virus most likely came from a laboratory – but days later, the scientists began dismissing such scenarios as ‘implausible’ and branding them conspiracy theories.
The critical call is at the centre of concerns that the scientific establishment tried to stifle debate on the pandemic’s origins, as damning new evidence emerges of US ties to high-risk research on bat viruses in Wuhan, where the first cases emerged in late 2019.
The Mail on Sunday requested emails, minutes and notes on the call between Sir Patrick Vallance – Britain’s chief scientific adviser – and its organisers Sir Jeremy Farrar, director of the Wellcome Trust medical charity, and Anthony Fauci, the US infectious diseases expert and presidential adviser.
Yet when the documents were released they had page after page redacted with thick lines of black ink by Whitehall officials. Even the names of experts copied in on discussions were blocked – and exchanges as trivial as one Edinburgh biologist’s ‘thank you’ for being invited – leaving only a few basic details about the call visible.
The lines left intact include a demand for the discussions, involving 13 participants around the world, to be conducted in ‘total confidence’, and an intriguing email line suggesting ‘we need to talk about the backbone too, not just the insert’.
-See full-text of article
But this all begs another question: why is our own Government redacting key documents and refusing to share information it holds on events that might help us grapple with the mystery of the pandemic’s origins after almost five million deaths?
Leslie Manookian suing Pfizer on behalf of Naomi Wolf’s Dailyclout volunteers via their research from the Pfizer documents
https://rumble.com/v180603-lawsuits-on-lawsuits-dr.-naomi-wolf-walks-through-magas-legal-strategy-to-t.html
https://lesliemanookian.com/about/
Where’s the Emergency?
18 Congress Members Demand Answers as FDA Looks to Approve COVID Shots for Kids Under 5
Members of Congress today demanded answers from Dr. Robert M. Califf, commissioner of the U.S. Food and Drug Administration, as the agency reviews Emergency Use Authorization for COVID-19 shots in children age 5 and under.
https://childrenshealthdefense.org/defender/congress-members-fda-approve-covid-shots-kids/
Finally, the letter asks Commissioner Califf to “please list the medical emergencies [among] children 0 to 4 years old that enables the FDA to approve the COVID vaccine for children using its EUA.”
Mary Holland, Children’s Health Defense (CHD) president and general counsel, called the FDA’s Future Framework proposal “quite possibly the worst idea in the history of public health.”
In a video, Holland asked viewers to send a message to FDA and CDC officials, VRBPAC members and elected representatives demanding they reject the EUAs for children and ensure government agencies follow the science:
https://rumble.com/v17kapr-tell-the-fda-no-authorization-of-covid-shots-for-babies-and-children.html
Yes, it is a step by step approach, and it also concerns media and journalists.
Today, the media is just another ‘branch’, in the ‘tree of porkers’, aiding with keeping unwanted voices silent.
The future for ‘open debate’ looks designed by Soviet or CCP, if you do not comply you will be ‘de-platformed’. And Media agrees, because they become enforcers, naming who is allowed a voice.
‘Misinformation’ and ‘fake news’ are used to label critics.
So when Pharma uses its ‘measures’ to assure trial success, there is no one there to question them. And it’s all done in the open.
Ove2022
US: Pfizer COVID-19 shot appears effective for kids under 5
A review by federal health officials says that Pfizer’s COVID-19 vaccine appears safe and effective for children under 5, the only group not currently eligible for vaccination
June 13, 2022, 2:45 AM
https://abcnews.go.com/Health/wireStory/us-pfizer-covid-19-appears-effective-kids-85349843-85349843
The Food and Drug Administration posted its analysis of the Pfizer shot ahead of a Wednesday meeting where outside experts will vote on whether the shots are ready for the nation’s 18 million babies, toddlers and preschoolers. Kids under 5 are the only group not yet eligible for COVID-19 vaccination in the U.S.
Late last week the FDA posted a similar analysis of Moderna’s shots for children under 6.
If regulators clear the shots by one or both companies, vaccinations could begin as soon as next week with the drugmakers ready to rapidly ship doses ordered by the government.
Parents have been pressing federal officials for months for the opportunity to protect their smallest children as more adults shed masks and abandon other public health precautions.
While only about 3% of U.S. COVID cases are in the age group 6 months to 4 years, hospitalization and death rates in that group are higher than those for older children, according to the FDA’s analysis — one reason experts have said protecting this group is important.
The FDA said children who received Pfizer’s shots during testing developed high levels of virus-fighting antibodies expected to protect them against coronavirus. That’s the basic threshold needed to win FDA authorization. But additional testing turned up key differences, with stronger results for Pfizer.
Pfizer’s vaccine, given as a three-shot series, appeared 80% effective in preventing symptomatic COVID-19, although that calculation was based on just 10 cases diagnosed among study participants. The figure could change as Pfizer’s study continues.
Moderna’s two-dose series was only about 40% to 50% effective at preventing milder infections, though the two companies’ shots were tested at different times during the pandemic, when different variants were circulating. Moderna has begun testing a booster for tots.
On Wednesday, the FDA will ask an independent panel of vaccine experts to debate both companies’ data before voting. The FDA is not required to follow the group’s recommendations, but the process is seen as a key step in publicly vetting the shots.
The FDA is expected to make its official decision shortly after Wednesday’s all-day meeting. The next step: the Centers for Disease Control and Prevention, which recommends how to use vaccines, will convene its own expert panel to debate which tots need vaccinations.
It’s not clear how much demand there will initially be for the shots. A recent survey suggests only 1 in 5 parents of young children would get their kids vaccinated right away. Vaccines have been available since November for older U.S. schoolchildren, yet less than a third of those ages 5 to 11 have gotten the two recommended doses, according to government figures.
For the youngest children, each company is offering different dose sizes and number of shots, beginning at 6 months through 4 years for Pfizer and through 5 years for Moderna.
Pfizer and its partner BioNTech plan to offer two shots three weeks apart followed by a third at least two months later — each one-tenth the dose given to adults. Pfizer is currently the only company with a COVID-19 vaccine for older U.S. children.
Moderna is seeking FDA clearance for two shots, each a quarter of its adult dose, given about four weeks apart.
The FDA currently allows Moderna’s vaccine to be used only in adults. But some countries allow full-size doses for teens and half-size shots for kids ages 6 to 11 — a step the FDA also is considering.
More than 30,000 U.S. children younger than 5 have been hospitalized with COVID-19 and nearly 500 coronavirus deaths have been reported in that age group, according to U.S. health officials.
The government allowed pharmacies and states to start placing orders for tot-sized doses last week, with 5 million initially available — half made by Pfizer and half by Moderna.
Tim’s comment on Rxisk blog re ‘fit notes’
tim says:
June 13, 2022 at 10:38 a
……. multi-systems, life-changing and life-limiting injuries have resulted from misdiagnosed akathisia, and then long term, enforced use of highly toxic, prescribed drugs which caused life-threatening adverse reactions. All of these adverse drug reactions were serially misdiagnosed as ‘Severe Mental Illness’.
Diagnostic category: Cascade Iatrogenesis.
When these mandates below are introduced, depending of whether they can be trusted not to add more caveats .it could be an opportunity for people to add Tim’s brilliant ‘Dignostic Category :Cascade Iatrogenesis’
themselves to medical notes. If enough are prepared to ‘Access and Contribute’ to shared records it could make a difference? Even eventually be given an honest code..Cascade Iatrogenesis to be used in training and medical literature.
Government considering ‘mandating’ patient access to GP records
Caitlin Tilley Pulse
13 June 2022
The Government is considering ‘mandating’ access for patients to their GP records, as is done in the United States, it has announced.
This would make it ‘easier’ for GP patients to get hold of their data and records, the Department of Health and Social Care (DHSC) said.
The DHSC’s final data strategy, published today, said the Government is ‘looking at how we can make it easier for patients to access their own data and GP records, including mandating access as they have done in the United States’.
As of April last year, health organisations in the United States are required to share medical records with patients electronically and for free.
(This could be a sticking point) ‘It remains unclear what exactly would be mandated and what this would mean for GPs.
However, the DHSC also today indicated that patient access to GP records on the NHS App is again delayed until November, following rumours it would launch in July this year.
It said: ‘We will improve access to GP records in the NHS App by giving patients access to their latest health information (November 2022).’
Meanwhile, the Government admitted in the document that it had made a ‘mistake’ when it tried to re-launch plans for mass patient data sharing last year.
It said: ‘In the summer of 2021, we made a mistake and did not do enough to explain the improvements needed to the way we collect general practice data.’
It added: ‘Not only did we insufficiently explain, we also did not listen and engage well enough. This led to confusion and anxiety, and created a perception that we were willing to press ahead regardless.’
Government-commissioned review lead Professor Ben Goldacre previously said that trying to re-launch the data sharing programme last year was ‘a mistake’ before a ‘trusted research environment’ had been guaranteed.
NHS Digital is currently analysing results from a survey of GP practice staff about their views on digital data.
The final data strategy also said:
There will be a simplified opt-out process for patients not wanting their data shared as part of General Practice Data for Planning and Research (GPDPR)
Trusted Research Environments (TREs) will be created to allow researchers access to NHS data without compromising patient safety, as recommended by Professor Ben Goldacre in his recent Government-commissioned Goldacre Review.
A digital health and care plan will be published ‘shortly’.
Speaking today at the HealthTech summit, health secretary Sajid Javid said: ‘We will improve trust in data, which is the currency that data-driven technologies need to function.
‘We will work with the public, including people working in health and care, to develop a new pact on data, which will set out how we will use health and care data, and what the public has the right to expect.’
He added: ‘This will include the ability to opt out of sharing data because although we know that most people want their data to be used for good, we will make the opt-out system simpler and more transparent.’
//// the launch date was delayed until April 2022 for both systems, after the BMA wrote to NHSX expressing its concerns about the timing of the rollout.
It was then delayed again, with NHS England recognising concerns around ‘safeguarding’, but it remained unclear when the launch would finally take place.
Under the plans, patients will not be able to make changes to their GP records at this time, although a Government white paper published in February said that plans were ‘underway’ for patients to be able to access and contribute to their shared care record.
Beyond any comment
Operose Health: What I saw working undercover at a GP surgery
By Jacqui Wakefield
BBC Panorama
Published7 hours ago
Share
Jacqui Wakefield
For six weeks I worked undercover as a receptionist in a GP surgery owned by Operose Health, the UK’s biggest GP chain. Most practices in England are privately owned by GP partners, but a rule-change in 2007 allowed bigger companies to buy up partner-led surgeries.
Operose Health has grown rapidly in recent years – it has spent millions buying GP practices. It now runs 70 surgeries with nearly 600,000 patients, making it the biggest GP provider to the NHS.
Across the UK, there is a shortage of GPs and general practice is under unprecedented pressure. Former Operose employees who spoke to Panorama – a dozen doctors, nurses, pharmacists and other staff – said they believed patient safety was being put at risk.
Our investigation found the company let less qualified staff see patients, rather than doctors, without adequate supervision.
Operose denies profit is being prioritised ahead of patient care and says it has a clear process of supervision.
This is the diary of my time working in a busy Operose GP practice in London.
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Thursday 7 April – ‘We run on locums’
It’s my second shift at the practice and already I’m dealing with a serious complaint. A patient came in and told me his GP had been absent and unreachable through his struggles with mental health. Last year, he had spoken to his GP but after this appointment he hadn’t had any engagement from the practice.
He said he hadn’t been able to get his new prescription, or to create a mental health plan with his GP. The patient said he felt completely abandoned.
The other receptionists are telling me this practice “runs on locums”, meaning a lot of the GPs who work here are like freelancers – only working a shift here or there.
1px transparent line
Monday 11 April – The ‘cheaper’ physician associates
Today I met one of the less-qualified clinicians known as a physician associate (PA). I could only speak to her for a few minutes as she rushed to her next appointment, but she quickly opened up about how she felt she was being treated exactly like a GP.
She appeared stressed, telling me that from day one on the job she had been thrown in as if she had the experience of a GP, despite this being her first job out of training.
I hadn’t heard of a PA before this. I asked my manager and they told me they were like GPs but couldn’t prescribe. I asked why we wouldn’t just have more doctors and my managers told me that each PA cost less than half that of a GP and were therefore cheaper.
line
Watch Panorama’s Undercover: Britain’s Biggest GP Chain at 20:00 on BBC One on Monday 13 June
PS worth asking ourselves why Sam Etheringtom was expressing so much shock and surprise on the documentary. This kind of knowledge must have been doing the rounds amongs his contacts Why did he not speak out before this panarama programme was being made??
Professor Sir Sam Everington
Associate Non-Executive Director
Email Professor Sir Sam Everington
Registered interests
Status on NHS Resolution Board
Non-Executive Director
Main occupation/employment
GP, Bromley-by-Bow Partnership
Directorships, partnerships or registrable shareholdings
Partner, Bromley-by-Bow Partnership
Committee Member, North East London CCG
Partner GP, XX Place Health Centre
Partner GP, Bromley-by-Bow
Partner GP, St Andrews
Partner GP, Pauls Way
Deputy Chair, Tower Hamlets Health and Wellbeing Board
Non-Executive Director, East London Foundation Trust
Chair, HEE Medical Apprenticeship Committee
Chair, NHSX Outpatient Referral Committee
Clinical Chair, Tower Hamlets CCG
Deputy Clinical Chair, North East London CCG
Director, Greenlight GP Connect Ltd. (joint venture with Bromley-by-Bow)
Membership of governing bodies or other public bodies
GP Member, GP Care Group CIC
Council Member, British Medical Association
Vice President Queens Nursing Institute
Fellow and Honorary Professor, Queen Mary University of London
Member of NHS Strategic Infrastructure Board
Vice President and Council Member of the College of Medicine
Member of Royal College of GPs
Member of MDDUS
Member of Nesta Advisory Board
Member of HEE GP Pilot Committee
Interests of close family members
Wife is a Partner in Bromley-by-Bow Partnership
Wife is a Board member of Tower Hamlets CCG
Wife is a GP partner member of the MDDUS
Wife is Vice President and Council Member of the College of Medicine
Celebrity Dr’s (Looking and sounding the part) seem to be popping up everywhere. Startled to see last week 3 celebrity Dr’s endorsing and promoting SSRI’s for premature ejaculation. (Channel 4 Embaressing bodies).
FDA Advisers Review Moderna, Pfizer COVID-19 Shots for Kids as Young as 6 months
Kids under 5 are the last remaining age group to get vaccinated
By Lindsey Tanner and Mike Stobbe • Published 14 mins ago • Updated 10 mins ago
https://www.nbcnewyork.com/news/coronavirus/fda-advisers-review-moderna-pfizer-covid-19-shots-for-kids-as-young-as-6-months/3735363/
If the FDA clears the shots, there’s one more step. The Centers for Disease Control and Prevention will decide on a formal recommendation after its own advisers meet Saturday.
If the CDC signs off, shots could be available as soon as Monday or Tuesday at doctor’s offices, hospitals and pharmacies. Roughly 18 million youngsters would be eligible.
Pfizer’s vaccine is for children 6 months through 4 years; Moderna’s is for 6 months through 5 years.
The same FDA panel on Tuesday backed Moderna’s half-sized shots for ages 6 to 11 and full-sized doses for teens. If authorized by the FDA, it would be the second option for those age groups. Currently Pfizer vaccine is their only choice.
@jikkyleaks
If you haven’t already seen Sam Dobson’s 3 minute evisceration of the FDA please watch it or listen to it. Again and again.
They must not be allowed to get away with what they have done.
This is brilliant
@TTLBoats @JesslovesMJK
https://rumble.com/v18l13s-my-feedback-to-the-fdas-attempts-to-inject-5-and-under-for-covid-19.html
FDA Panel Recommends Pfizer, Moderna COVID Shots for Babies and Young Kids, Ignores Risks
https://thevaultproject.org/fda-panel-recommends-pfizer-moderna-covid-shots-for-babies-and-young-kids-ignores-risks/
The U.S. Food and Drug Administration’s (FDA) vaccine advisory panel today unanimously voted 21-0 to recommend Pfizer and Moderna’s COVID-19 vaccines for infants and young children, stating the totality of the evidence available shows the benefits of the vaccines outweigh the risks.
Pfizer’s three-dose vaccine would cover children 6 months to 5 years old, while Moderna’s two-dose vaccine covers children 6 months to 6 years old.
States have already ordered millions of doses made available prior to FDA authorization by the Biden administration.
Depending on whether the FDA and Centers for Disease Control and Prevention (CDC) accept the recommendations of their advisory panels, White House officials have said the administration of vaccines for these age groups could start as early as June 21.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) ignored pleas from experts, the vaccine injured and a congressman representing 17 other lawmakers to halt authorization until questions about the safety and efficacy of COVID-19 vaccines for the nation’s youngest children could be properly addressed.
Brook Jackson Retweeted
World Council For Health (WCH)
@WCH_Org
Dr. Kat Lindley Tells the FDA NO Covid-19 Vaccines for Kids Listen to what she had to say and be sure to share.
https://worldcouncilforhealth.org/news/2022/06/vrbpac-fda-kat-lindley/77161/
Josh Guetzkow
@joshg99
From @TTLBoats : “You might also want to figure out how we’re going to diagnose myocarditis in very young babies who are unable to speak” and tell you their little hearts are hurting.
https://rumble.com/v18l13s-my-feedback-to-the-fdas-attempts-to-inject-5-and-under-for-covid-19.html
Jane
Thank you Dr Guetzkow and I hope that this will aid our own Sir Christopher Chope, in his campaign for the many victims of vaccine injury here in the UK.
To date, his efforts have met with official evasions.
Josh Guetzkow
@joshg99
·
3h
New FOIA Release Shows CDC Lied about Its VAERS Safety Monitoring Efforts. The reason they never found any safety signals is because they didn’t look for them, then claimed absence of evidence was evidence of absence. Disgraceful.
https://jackanapes.substack.com/p/new-foia-release-shows-cdc-lied-about…
@CDCgov
@CDCDirector
https://jackanapes.substack.com/p/new-foia-release-shows-cdc-lied-about
Back in September, I published an article in CHD’s The Defender, where I showed the alarming and unambiguous safety signals coming from the Vaccine Adverse Events Reporting System (VAERS), using the CDC’s own published methodology. In that article, I wondered out loud why, if the safety signals were so blaringly obvious, nobody was doing anything. Was anybody listening?
Well, it turns out the CDC wasn’t even looking for safety signals! They said they were going to use the most basic, standard pharmacovigilance method by calculating what are called proportional reporting ratios (PRR’s) to monitor VAERS (see the article linked above for more details). But it turns out they didn’t. And then they turned around and said they weren’t seeing any safety signals in VAERS. They forgot to mention that they weren’t looking for any.
They took a page from the pharma playbook: don’t look for safety problems, then claim that absence of evidence is evidence of absence. Maybe they think it’s OK if you do it with your fingers crossed behind your back.
Josh Guetzkow
@joshg99
Looks like @SenRonJohnson is demanding answers from @CDCDirector about why they didn’t do the VAERS safety signal analysis they promised the American people, which I uncovered via FOIA request. Doubt he’ll get an answer. Easier to ignore than to own up to dereliction of duty.
Senator Ron Johnson Retweeted
Phil Kerpen
@kerpen
NEW: @SenRonJohnson is asking @CDCDirector why the CDC told @joshg99 in a FOIA response that they failed to conduct their promised PRR analysis. Letter –>
https://www.ronjohnson.senate.gov/services/files/9914278B-A73B-4434-8349-91091138E18B
“Public health agencies’ ability to track and warn the public of potential adverse events connected to the COVID-19 vaccines is dependent on those agencies performing routine and thorough data analyses. As discussed during the October 22, 2020 teleconference on vaccine surveillance systems, a CDC official noted that CDC and FDA planned to use VAERS to conduct “data mining . . . every one to two weeks.”12 That official praised VAERS stating that it can “rapidly detect safety signals and can detect rare adverse events.”13 Indeed, as of June 10, 2022, VAERS reported 28,859 deaths worldwide following COVID-19 vaccination with 7,890 or 27 percent of those deaths occurring on day 0, 1, or 2 following COVID-19 vaccination.14 Given the effectiveness of VAERS to “detect safety signals,” it is unclear why CDC did not generate all the tables using VAERS and other surveillance data on COVID-19 vaccine adverse events even though it initially indicated that it would perform such analyses.”
cc: The Honorable Robert M. Califf Commissioner Food and Drug Administration
Beyond Pills..
Doctors must stop over-prescribing as if there is a ‘pill for every ill’ so money can be better spent on tackling waiting lists, NHS chief says
https://www.dailymail.co.uk/news/article-10925509/Doctors-stop-prescribing-pill-ill-NHS-chief-says.html
At least 15 per cent of the population – 8.4million people – take more than five drugs a day, with primary care prescriptions costing the NHS in England £9.7billion a year.
I’m proof that GPs are too quick to prescribe pills
Today’s Beyond Pills campaign launch aims to highlight the overprescription of ‘unnecessary’ drugs, something I’m all too familiar with
https://www.telegraph.co.uk/health-fitness/body/nation-taking-many-pills-should-know/
This experience is a big reason why I, a health writer for the past 35 years, am adding my support to the Beyond Pills Campaign, which launches today at the Integrative and Personalised Medicine Congress in London. We are campaigning to reduce the overprescription of pills when they might be unnecessary, and to show the value of non-drug alternatives.
I know I’m not alone in having these experiences. Since my involvement in the Beyond Pills Campaign, I have met Debs Teale, who from the age of eight for the next three decades was prescribed a cocktail of drugs for panic attacks. “I was prescribed more and more drugs – antipsychotics, antidepressants and sleeping pills,” she told me. “Some were to counteract the side effects of the other drugs. I was often bedbound because they made me feel so ill. I’d been medically retired from work. I ended up taking 21 tablets every day.
https://www.ipmcongress.com/whole-person-health-conference-draft/beyond-pills-is-over-medicalisation-over-moving-towards-a-less-medicalised-model-of-healthcare
Beyond Pills Campaign – is over medicalisation over? Moving towards a less medicalised model of healthcare.
And; Vaccines…
‘The Ums and Ahs…
“Science by PRESS RELEASE”
Dr. John Campbell
C.D.C. Recommends 2 Covid Vaccines for under 5s
https://www.youtube.com/watch?v=6Z7RyGWLqAM
CDC Recommends COVID-19 Vaccines for Young Children
Media Statement
For Immediate Release: Saturday, June 18, 2022
https://www.cdc.gov/media/releases/2022/s0618-children-vaccine.html
FDA NEWS RELEASE
Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-children
“COVID-19 vaccines have undergone—and will continue to undergo—the most intensive safety monitoring in U.S. History.” …
Strokes, blood clots, wheelchairs: B.C. patients describe rare reactions to COVID vaccines
FOI documents detail health officials responding to bad reactions to COVID vaccines in early days of pandemic
As British Columbians were starting to get COVID-19 vaccinations in December 2020 and the first half of 2021, health officials were behind-the-scenes carefully tracking serious side-effects from the shots, according to documents recently released under the Freedom of Information Act.
Talk about a history of cover up That goes all the way back to early 2021
https://vancouversun.com/health/strokes-blood-clots-wheelchairs-bc-patients-describe-rare-reactions-covid-vaccines?utm_medium=Social&utm_source=Facebook#Echobox=1655680497
“Doctors in B.C. … agree that the vaccine was the catalyst for his stroke. We cannot change this for (name redacted) but investigating this might prevent someone else from suffering the same outcome,” said the email. The sender’s name was removed.
“Henry asked officials to follow up, but Interior Health’s detailed response was also erased from the FOI documents, so it is difficult to tell whether this was an isolated case. The Journal of the American Medical Association, though, published research in November, 2021, showing no increased prevalence of stroke following vaccine shots.
“ a Jan. 17, 2021 email from the Public Health Agency of Canada reported the death of an prisoner in a B.C. prison after receiving the Moderna dose, although the Correctional Service of Canada did “not consider the death to be linked to the vaccine.”
It was impossible to determine the accuracy of all the concerns raised in the FOI. For example, the documents included an email from Dr. Charles Hoffe saying his Lytton-area patients suffered ill effects after getting vaccinated.
The B.C. College of Physicians and Surgeons, though, would later allege that Hoffe had made “misleading, incorrect or inflammatory” statements about COVID, including that vaccinations cause “microscopic blood clots that cause serious neurological harm, female infertility and a high number of deaths.”
Take a look at this article:-
https://mylongcoviddiaries.medium.com/i-finally-have-a-diagnosis-for-long-covid-and-its-shocking-82ddcb214656
The case in question is a ‘Long Covid sufferer’. Notice how many different tests were done and how long it has taken for this “diagnosis” to be given.
A member of our zoom meeting group had suffered for months from protracted withdrawal. Following his second Covid vaccination last May he began to suffer additional symptoms. He was putting them all down to the withdrawal – we were pushing for him to look at all avenues possible just incase there was a physical cause responsible for this increase in symptoms.
He was assessed by a variety of consultants – comments being made on the condition of his heart ( don’t take exercise beyond a gentle walk) and his nervous system ( possibly anxiety related but your legs are really tight at the moment). The assessments details sent to his GP failed to show any of these concerns. Due to this he was treated as a case of “worsening anxiety”.
A month or so ago, he collapsed and was taken to hospital. Within days, it had been established that he had a myriad of tiny blood clots and a number of larger ones in his lungs. Many scans were arranged for other organs where they also expected to find blood clots. He was told that part of one lung had died. Suddenly things changed quite dramatically – the blood clots ( which he had seen with his own eyes on the scans), he was told, were a “false positive” and he was suffering from pericarditis and transferred to the cardiac ward, away from the respiratory team. The pericarditis has since been changed to pleuricy but medications for those two conditions are making not one iota of difference to his condition. Noone seems to offer an explanation for his pain and suffering. He was told to go home and wait for an outpatient appointment to check on his progress in 6-8 weeks’ time. One person told him, quite early on, that “the Government haven’t offered us any guidance on how to treat conditions like yours”.
For weeks now, he has become convinced that his problems stem from the Covid vaccine. Whilst researching on his phone from his hospital bed, he came across the article linked above. He took particular notice as he has recently been in touch with the very doctor mentioned in the article. He should get a zoom-type call within two weeks.
The tests, the lack of understanding what is going on within a patient’s body etc. etc. mentioned in the article, mirrors his condition and treatment so far. To his knowledge, he has not had Covid – just the vaccine and a deterioration in health from the date of that second jab. How many more are stuck in our hospitals without the correct diagnosis and treatment?
Having been in regular contact with this lad through thick and thin for many months now, on reading the article that he sent me I was horrified. It was just like re-reading all the emails that he has sent me over the past weeks. I am so glad that we persuaded him to push for a better understanding of his physical health rather than taking for granted that all of this was down to his withdrawal from antidepressants. I hope that he gets to see his Dr Man – awaiting that appointment is helping him to cope with his present situation.
This is such a sad case – only one of very many I guess but it’s the story of one very special person who was struggling with withdrawal symptoms only to be hit a second time, again, only because he “followed the guidelines” and did his bit for society. We all deserve better care than this!
@mary h
Yes we all do deserve better.
Hopefully his dr can shed more light and give him the medical support he needs.
There are a few support groups that can be very helpful, particularly the one on React19.org website and their fb group.
Loads of information. Although no guarantees, everyone is scrambling trying to one treatment over another. What works for some people might not work for another person
Btw Apologies. Just noticed your comment now
thanks for this information Shall certainly pass it on to him.
Further to my comment above – Dr Man’s appointment happened last evening. This confirms the fact that all his problems are vaccine related. The doctor may have been able to work with our friend if he could have afforded to be a private patient and been well enough to travel to London for tests etc. the doctor is reporting to the local GP confirming his ideas for supporting this person. Noone here offers treatment as such as we know, the best that can be offered is fairly long term use of blood thinners.
I have today passed the information about the website and fb group that you previously included in a comment Nina. Had kept it to myself until he’d had yesterday’s appointment. i hope he will get some relief by sharing with others who are suffering in a similar way.
))ay( Retweeted
Jikkyleaks (Fan account)
@Jikkyleaks
·
4h
The fact that there has been no protest at the @US_FDA following the most corrupt and inept decision ever to emerge from that institution tells them that you never really had a red line.
The children actually don’t matter, as it happens.
Clare Craig vs CDC director // EUA amendment request for Pfizer-BioNTech COVID-19 Vaccine for Children and babies
https://rumble.com/v197mj7-eua-amendment-request-for-pfizer-biontech-covid-19-vaccine-for-children.html
The government has committed to buying Moderna’s vaccines for the next decade.
The Government’s chief scientific adviser Sir Patrick Vallance said the announcement is ‘great news for the UK’s R&D activities and future capabilities’.
https://www.dailymail.co.uk/news/article-10941635/Government-s-Moderna-partnership-bring-1-billion-investment.html
NHS patients to have access to next generation of mRNA vaccines and treatments.
Press release
Moderna to open vaccine research and manufacturing centre in UK
https://www.gov.uk/government/news/moderna-to-open-vaccine-research-and-manufacturing-centre-in-uk
Patrick Vallance, Government Chief Scientific Adviser, said:
The establishment of the Moderna mRNA Innovation and Technology Centre is great news for the UK’s research and development activities and future capabilities.
Rapid cutting-edge vaccines were vital in the response to the COVID-19 pandemic. Developing the next generation of mRNA vaccines will be crucial in boosting our ability to prevent and respond to a wide range of diseases in the future.
Clinical trials are used to determine whether a new treatment is safe and effective. All treatments must undergo three robust stages of trials to gather enough data for medical regulators to approve them for use in humans.
Good to Know – leave One, back Another…
Covid Vaccines More Likely to Put You in Hospital Than Keep You Out, BMJ Editor’s Analysis of Pfizer and Moderna Trial Data Finds
A new paper by BMJ Editor Dr. Peter Doshi and colleagues has analysed data from the Pfizer and Moderna Covid vaccine trials and found that the vaccines are more likely to put you in hospital with a serious adverse event than keep you out by protecting you from Covid.
The pre-print (not yet peer-reviewed) focuses on serious adverse events highlighted in a WHO-endorsed “priority list of potential adverse events relevant to COVID-19 vaccines”.
The authors evaluated these serious adverse events of special interest as observed in “phase III randomised trials of mRNA COVID-19 vaccines”.
https://dailysceptic.org/2022/06/22/covid-vaccines-more-likely-to-put-you-in-hospital-than-keep-you-out-bmj-editors-analysis-of-pfizer-and-moderna-trial-data-finds/
They conclude that there is a need for formal harm-benefit analyses for Covid vaccines, taking into account the different levels of risk of serious Covid and adverse events that exist between demographic groups. Ideally, this would be based on individual participant data, they say, though such data remain frustratingly unavailable.
Vaccine Damage Payment Scheme: The battle for compensation
https://www.bbc.co.uk/news/health-61898694
A group of 95 people who developed health problems or lost relatives as a result of rare side-effects of the Oxford-AstraZeneca Covid-19 vaccine say they have been let down by the “out-of-date” government payment scheme.
One woman whose fiance died after the jab was awarded £120,000 this week.
BBC News has since learned two more people have been told they will receive payments.
But many more are still waiting for their cases to be assessed, despite some having final death certificates meaning senior doctors and lawyers have concluded the vaccine caused their loved one’s death.
Added to which, we should be concerned about the future of those who have survived these damages. Their future needs are likely to become a heavy burden for their families – especially, it seems, if they were already known to the Health Service as suffering from “anxiety”. Not all anxiety sufferers are on Benefits but it’s quite likely that the burden of vaccine damage combined with feelings of helplessness/ hopelessness/ being a burden etc. will tip the scales and leave them at the mercy of the DWP. Whilst doctors/ consultants etc. refuse to state the obvious – that it is vaccine damage – their applications for support from the benefits system will likely be open to very many tests and questioning too.
The Government wanted us all to get vaccinated – the vast majority did – many of that majority have suffered to a larger or lesser degree – yet the attitude towards those unfortunate enough to suffer, once again, seems to be that “the benefits outweigh the risks”, which is fine unless you’re one of the damaged number. Their voices MUST be heard.
On Information Commissioner website
Your right to get your data corrected
You can challenge the accuracy of personal data held about you by an organisation, and ask for it to be corrected or deleted. This is known as the ‘right to rectification’. If your data is incomplete, you can ask for the organisation to complete it by adding more details.
How to get your data corrected
To exercise your right you should inform the organisation that you are challenging the accuracy of your data and want it corrected. You should:
state clearly what you believe is inaccurate or incomplete
explain how the organisation should correct it, and
where available, provide evidence of the inaccuracies.
A request can be verbal or in writing. We recommend you follow up any verbal request in writing because this will allow you to explain your complaint, give evidence and state your desired solution. It will also provide clear proof of your actions if you decide to challenge the organisation’s initial response.
How should I raise my complaint about how an organisation has handled my information?
You can use the template letter below to help begin a complaint
[Your full address]
[Phone number]
[The date]
[Name and address of the organisation]
[Reference number (if provided within the initial response)]
Dear [Sir or Madam / name of the person you have been in contact with]
Information rights complaint
[Your full name and address and any other details such as account number to help identify you]
I am concerned that you have not handled my personal information properly.
[Give details of your complaint, explaining clearly and simply what has happened and, where appropriate, the effect it has had on you.]
I understand that before reporting my complaint to the Information Commissioner’s Office (ICO) I should give you the chance to deal with it.
If, when I receive your response, I would still like to report my complaint to the ICO, I will give them a copy of it to consider.
You can find guidance on your obligations under information rights legislation on the ICO’s website (www.ico.org.uk) as well as information on their regulatory powers and the action they can take.
Please send a full response within one calendar month. If you cannot respond within that timescale, please tell me when you will be able to respond.
If there is anything you would like to discuss, please contact me on the following number [telephone number].
Also
The Patients Association
A guide to formally requesting medical records
Your records include any information about your physical or mental health recorded by a healthcare professional.
Some of the most common reasons for accessing medical records include: understanding a condition, coming to terms with a medical event or preparing to make a complaint.
You have a legal right to see your own records. You do not have to explain why you want to see them.
Your request could be refused if:
A health professional thinks seeing the records would be seriously harmful to your physical or mental health
The records also relate to someone else.
Can I nominate someone else to see my records?
Yes. You can nominate someone else, for example a solicitor, to view your records. You must provide written consent.
Under General Data Protection Regulation (GDPR) accessing your medical records is free.
How to get your GP records
You can view a summary of your GP records online. To do this register for online services.
If you do not wish to use the online service, see section 4 for advice on formally requesting your medical records.
How do I register for online services?
Find out what online service provider your GP uses. You can do this by asking them or visiting the surgery website
Tell your GP surgery you want to sign up for online services either over the phone or in person.
How else can I view my GP records?
You can also view your GP records using the NHS App. See next section for more information.
The NHS App is free to download from the App Store and Google Play.
You can formally request your medical records in writing. You may wish to do this if:
You want hard copies of records
Here is a step-by-step guide to formally requesting your medical records:
Step 2
Write a letter or email making a formal request for copies of your records. Include information on exactly what you want to see. This template letter may be helpful.Your address
Postcode
Email address
Date
Name of GP practice / Hospital
Address
Postcode
Dear Sir/Madam,
I would like to apply to see/have copies of my medical records under the Data Protection Act 1998.
My details are:
Full name and any previous name(s) used
Date of birth
Hospital number
NHS number
GP’s name and surgery address
I would like to see/have copies of all my records/my records from (insert date) to (insert date). I am
particularly interested in any records you have about my treatment for (insert medical conditions,
In Wales – trawl through this lot….
Amending patient and service user records
20 January 2022
amending patient and service user records guidance
This guidance provides advice on patients and service users requesting changes to their health and care records. It also covers how staff should amend records.
Guidance for patients and service users
If you think that the health or care information in your records is factually inaccurate, you have a legal right to ask for your records to be amended. You may also ask for something you feel has been inaccurately recorded, such as a diagnosis, to be corrected. However, it may not be possible to agree to your request.
Sometimes, you may disagree with information written in your record, but the information could still be factually correct. For example, you may disagree with a diagnosis you were given in the past. Whilst you can still ask the organisation to amend the entry that you feel is inaccurate, an organisation should not change it if the health and care professional believes it is factually correct.
In cases where all parties agree that the information is inaccurate, it may still be necessary to retain the information. For example, health and care professionals may have taken the information into consideration when making decisions about treatment or care. This information would therefore be needed to justify and explain health and treatment decisions or to audit the quality of care received. You can, however, request for a comment or entry to be made in the record to show that you disagree with the content and what you think it should say.
If you are unhappy with the decision of a health or care organisation to retain information you wish to have deleted there are some steps you can take. In the first instance, you can make a formal complaint through that organisation’s complaints process. If you are unhappy with the outcome of that process then you might consider making a complaint to the Information Commissioner’s Office (ICO) or consider legal action.
Patients and service users have the right to request for their records to be rectified if they feel inaccurate information is held about them. They may make a request concerning:
their opinion on the health or care information within their record, for example, they may not agree with the initial diagnosis given to them
If you believe that the amendment request concerns health or care information that is factually accurate, you should not amend the record. However, it is good practice to give patients and service users the opportunity to have an entry put into the record to say they do not agree with a particular part and why.
There may be times when information was correct at the time the entry was made but has since changed. For example, there may be an initial working diagnosis which was, at the time of entry, clinically possible, but is later ruled out with a different confirmed diagnosis. Retaining the original diagnosis does not make the record inaccurate, so it is important that this is not amended. It may help when recording information to indicate where something is your opinion rather than a confirmed diagnosis.
If you decide the health or care information in a record is inaccurate and need to amend it, the original entry must not be deleted. It must still be readable. This is because other health and care professionals may have read it and therefore may need to refer to it at a later date to justify their decisions.
Patients and service users have the right to rectification if you hold inaccurate factual information about them. Holding inaccurate information could be seen as a breach of UK GDPR.
Where there is a query from a patient or service user over the accuracy of the health or care information in a record, you should liaise with the health and care professional who entered the information to understand their views. You should seek to determine whether the data entry can be shown to be accurate, and whether their professional opinion was justified on the basis of the evidence that was available at the time the opinion was recorded. If they are not available, you should speak to their manager, professional lead or your Caldicott Guardian.
Where the health and care professional states that the record is correct, amending the record would not normally be allowed. This is because it would affect the authenticity and integrity of the record.
If an amendment is not made, then the patient or service user has the right to have an entry put into the record to say they do not agree with particular content and why.
Even where it is agreed that health or care information is inaccurate, you should advise health and care professionals that information must not be deleted without seeking the advice of the information governance team. This is because it will be necessary to consider who has viewed the inaccurate information and possibly relied upon it to make care and treatment decisions. The inaccurate information may therefore need to be retained so that it can be taken into account at a later date to understand a decision about the care received. Instead, you should add a note to the record explaining that the information is inaccurate and should no longer be taken into account.
If the requestor is unhappy with this decision, they may complain to the organisation. If they are still not happy after this, they can complain to the ICO, and also seek redress through the courts.
https://brownstone.org/articles/the-fdas-future-framework-for-covid-vaccines-is-reckless-plan/
“So Pfizer and Moderna have figured out a way to use regulatory capture to get their reformulated Covid-19 shots approved WITHOUT further clinical trials. Their scheme is called the “Future Framework” and it will be voted on by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 28.”
https://rumble.com/v19mpoi-dr.-toby-rogers-the-fda-wants-to-eliminate-clinical-trials-for-pharmaceutic.html
I thought they wanted to have 100 days trial..who knows let’s see
Meanwhile an art professor writes a book which will exploit young artists will to become famous and sell their work into the metaverse
https://www.artnews.com/art-news/news/magnus-resch-nft-art-market-interview-web3-1234632602/
“ARTnews: What are some of the key reasons that art world insiders are reluctant to enter this market? Aesthetics?
Resch: It’s never a discussion about aesthetics. There’s a few reasons why I think why they’re reluctant. Firstly, they’re turned off because suddenly works from artists which they have never heard of before are selling for millions of dollars. Secondly, it’s very hard to enter: wallets, Metamask, blockchain, these words alone can be scary to people. ”
He forgot vaccine passport to go…
Have to say this is brilliant manipulation and he is as much manipulated with his reference coming from the – all but closed to anyone except the rich – fine art contemporary market.
He said: ‘It’s life-changing but I didn’t do something that caused this. We just did what the government told is to do. I regret getting the vaccine. If I had known there was a chance of getting this, I wouldn’t have gone anywhere near it.
Father-of-two, 58, ‘left paralysed’ by first AstraZeneca Covid jab must use wheelchair and walking frame after 420 days in hospital
https://www.dailymail.co.uk/news/article-10945517/Stoke-grandfather-58-paralysed-Covd-19-jab.html
but since the advent of Covid, anti-vaxx zealots have been able to exert a disturbing influence, writes Prof HUGH PENNINGTON
https://www.dailymail.co.uk/debate/article-10947625/Bitter-price-yummy-mummy-anti-vaxx-mob-Polio-circulates-England-again.html
and partly because of the disinformation campaign against vaccines led by deluded conspiracy cranks and right-on middle-class households.’
Comparing the Covid vaccine roll-out to a recent find of polio, really is stretching a point and using defamatory language does nothing but inflame…
Another ‘Expert’ muddling-up on ‘disinformation’ …
Juan Gérvas
@JuanGrvas
“Eventos adversos graves de especial interés tras la vacunación covid19 con ARNm” El exceso de riesgo de sufrir un evento de salud grave en vacunados (15,1 por 10.000 participantes) supera a la reducción del riesgo de hospitalización por COVID-19.
Study at the universities of Maryland, Stanford, UCLA, and Navarra
(among others) shows that vaccines are neither effective, much less safe
https://extramurosrevista.com/estudio-universidades-maryland-stanford-ucla-y-navarra-entre-otras-demuestra-que-las-vacunas-no-son-ni-eficaces-ni-mucho-menos-seguras/?fbclid=IwAR0dN5_sq_3x-jPowuSJXz77KYDHzp-TUk-mZch_46zM9R7RwiOl-Cog3aw
* Getting vaccinated involves a relative increase of 43% in the risk of suffering a serious health event as a result, compared to the placebo group
* The main health problems caused by the vaccine are: blood clotting disorders, and heart problems (including myocarditis and pericarditis)
* The excess risk of suffering a serious health event in vaccinated (15.1 per 10,000 participants) outweighs the reduction in the risk of hospitalization for COVID-19
* Two other studies already published confirm these results. Observational post-vaccination data obtained by the FDA also confirms this
* The FDA also had this information before the emergency approval, and yet ignored them and made the approval decision.
* “Given the implications for global public health, it is urgent to make public all data from COVID-19 trials, in particular those relating to serious adverses, without further delay”
By Peter Doshi et. to. (*)
In March 2020, the Brighton Collaboration and the Coalition for Epidemic Preparedness Innovations, Safety Platform for Emergency vACcines (SPEAC) created and then updated a “priority list of potential adverse effects of particular interest for COVID-19 vaccine studies.”1 The list includes adverse events of particular interest (AESI) based on the vaccine-specific platform, adverse events associated with previous vaccines in general, theoretical associations based on animal models, and COVID-19-specific immunopathogenesis. The World Health Organization’s Global Advisory Committee on Vaccine Safety endorsed and recommended the notification of EAGEI based on this priority list. However, to our knowledge, the list has not been applied to serious adverse events in data from randomised studies.
We sought to investigate the association between FDA-cleared mRNA COVID-19 vaccines and serious adverse events identified by the Brighton Collaboration, using data from the randomized, placebo-controlled phase III studies on which the authorization was based. We then use the results to illustrate the need for formal harms and benefits analyses of vaccines that are stratified according to the risk of severe COVID-19 outcomes, as well as to contextualize the results against post-authorization observational data.
cont’d
24 June 2022
Jeremy Wight
Re: Consenting children aged under 18 for vaccination and treatment Nina Pollok, et al. 377:doi 10.1136/bmj-2021-068889
Dear Editor,
This article, the authors write, is based on guidance and law applicable in the UK. UK law on informed consent is based on the Supreme Court’s Montgomery judgement in 2015. The General Medical Council updated its guidance on consent in 2020. Both of these sources emphasised the importance of providing comprehensive information about the possible benefits and risks of any procedure, to a person or guardian, before valid informed consent can be given. The article says little on this important aspect.
The authors comment that the covid-19 pandemic “ highlighted common legal and ethical dilemmas..” which is no surprise, as one doubts from many anecdotal accounts, if any of the vaccinated teenagers were informed of the vaccines‘ experimental status, of the lack of adequate safety studies and of any makers’ compensation liability. The MHRA figures on alleged deaths and ADRs following covid vaccination have not been publicised. Without such information, how can UK law, GMC advice, even the Nuremberg Code, have been respected ? (1,2,3)
In the past five years it has been pointed out many times in BMJ rapid responses that we have a dysfunctional system of consent to vaccination in the UK. That opinion, and the justifications for it, have not once been questioned by your global readership. (4,5,6 ) None of the reasons supporting those concerns about the dysfunctional state of consent to vaccination, were identified by the authors of this article.
1 of 1
Call to Action: Please complain to the ASA regarding the NHS poster advertising Covid-19 vaccines for children
Inbox
UK Medical Freedom Alliance office@ukmedfreedom.org via mlsend.com
4:30 PM (19 minutes ago)
to me
UKMFA CALL TO ACTION
Please complain to Advertising Standards Authority re NHS poster advertising Covid-19 vaccines for children 5-11 years
The UK Medical Freedom Alliance is calling on followers and members of the public to complain to the Advertising Standards Authority (ASA) about the recent NHS poster advertising Covid-19 vaccines for children aged 5-11 years
The process for doing this is included below:
Template submission – fill in the ASA form HERE using the following information:
Type of advert: In a personally addressed mailing
Platform: Other
Name of platform: Direct mailing via schools and posters at school
Brand of product: NHS Covid-19 vaccine advertised directly to 5-11 year olds
Describe your complaint:
– Relating to possible breaches of ASA Rules protecting children 5.1 and 5.2.
– Details and poster images in this article.
– Unethical to advertise a medical intervention/treatment directly to children aged 5-11 years. Use of cartoon action figures, the graphics and the typeface/language chosen are clearly aimed directly at children and not their parents.
– Coercive and manipulative to use psychological techniques on children implying they are a superhero to take the Covid vaccine and not a superhero if they don’t. Messaging exploits their credulity, as don’t have the life-experience and maturity to understand this is not to be taken literally.
– Reference to “Superheroes” may lead to children who don’t get the vaccine to believe that they are lacking in courage, duty and loyalty. May also create peer group pressure on an individual child to have the vaccine and potential stigmatisation and bullying of unvaccinated children by vaccinated children.
– The advert is for a medical intervention, yet no mention of potential risks/side-effects of Covid-19 jabs which undermines informed consent and may lead to physical harm. Mounting evidence of known, serious side-effects – myocarditis, clotting disorders, neurological conditions – which appear more common in the young. Long-term health effects are unknown. Children are at almost zero risk from Covid-19 so risks outweigh benefits of vaccines.
We recommend that all submitted complaints demand that this advert is immediately withdrawn.
Many thanks for your continued support
UK Medical Freedom Alliance
In an interview on radio Vikki Spit made the point that no part of the media would listen to what she was saying – and tried successfully at first to cancel her. The interviewer didn’t have the grace, or nerve, to apologise on behalf of them all Now the truth is out they cannot silence people any longer but there is still avoidance of informing the ‘public’ Much of what she said resonates with the way people raising concerns about psychiatric (and other ) drugs are treated. She was fobbed off by medics until her husbands brain became so swollen he was in agony and died.BBC Live 5 Breakfast News 23 June 22) gives a much better truth than this article.
Covid-19: UK makes first payments to compensate injury or death from vaccines
24 June 2022)
Cite this as: BMJ 2022;377:o1565
Jacqui Wise
The first compensation payments in the UK have been made to families who have been bereaved, or to people who have been injured, as a result of a covid-19 vaccine.
Vikki Spit from Cumbria is believed to be the first person to receive compensation, after her 48 year old partner, Zion, became ill eight days after receiving the AstraZeneca vaccine. Zion, a former rock singer, died at the Royal Victoria Infirmary in Newcastle in May 2021.
A handful of other people have received payments in the past few days under the government’s vaccine damage payment scheme (VDPS), which pays out up to a maximum of £120 000 (€140 000; $150 000).
Sarah Moore, a partner at the Hausfeld law firm, which is representing people seeking compensation, told The BMJ it was an important moment. “While the VDPS payments are very modest in amount, and will do very little to alleviate the financial difficulties with which many families are now struggling as a consequence of injury or bereavement, the fact of payment for some will mark a moment of vindication in that it is the clearest statement yet, by the government, that in some rare instances the covid-19 vaccines have caused very significant injury or death.”
However, it was “far too little, too late,” she said. “With a 60% disability eligibility criteria, a historical acceptance rate of 1.7%, and a maximum cap of £120 000, the inadequacies of the scheme mean that some families will have no choice but to look at litigation in order to access substantive financial support.”
Moore added that she believed that most of the payments so far have been made as a result of an individual experiencing vaccine induced immune thrombotic thrombocytopenia (VITT) or cerebral venous sinus thrombosis (CVST) after vaccination. But she said she knew of one payment for someone who had developed Guillain-Barré syndrome after covid-19 vaccination.
The NHS Business Services Authority, the body that handles the VDPS, confirmed that as of 20 May 2022 it had received 1681 claims in relation to covid-19 vaccines. A spokesperson emphasised that the VDPS was not a compensation scheme but one for payments to help ease the financial burden for those people who are severely disabled as a result of vaccination against a specific disease. All claims are medically assessed by an independent, third party medical assessor.
“The covid-19 vaccines are new. Establishing a causal relationship between the vaccines and their potential adverse effects is not a straightforward matter and has taken time,” the spokesperson told The BMJ. “It was vital we didn’t make assessments before the scientific evidence reached a more settled position, to avoid claims resulting in inconsistent outcomes, or disadvantaging claimants.
“We have to follow due process when progressing claims to ensure they are assessed in a fair and consistent way. As part of this process we must ensure that decisions are made based on all the evidence available. This requires gaining access to people’s medical notes and their previous medical history, so that the assessor can, having looked at all the evidence, determine whether there is a causal link and level of disability in each individual claim.”
The spokesperson said that the average (non-covid related) claim takes around six months to process from the date a claimant’s medical records are requested, because of the need to gather records from the claimants’ GPs, medical care providers, local authorities, or other relevant healthcare providers. “This can vary from case to case, and for covid-19 claims it has taken longer. We understand the frustration this is causing for claimants, and we appreciate their continued patience. We have scaled up a dedicated team of caseworkers to help speed up this process, support claimants through the application process, and provide regular updates on the progress of claims.
“Based on current timescales, once medical records have been sent for assessment, we expect to receive an outcome for most cases from the independent medical assessor within 12 weeks.”
Sorry I gave the wrong date above
here is the interview by Vikki Prit herself rather than the very simplified account by J Wise in the BMJ –
on Sounds playback
Radio 5 LiveOpen playback settings menu
5 Live Breakfast – 24/06/2022 – BBC Sounds
5 Live Breakfast
Released On: 24 Jun 2022Available for 28 days
starts at 1:44:43
Is the BMA interfering in what is written in thebmj? This is the second time in recent weeeks J Wise has ommitted serious information about the drugs/vaccines prescribed by medics ,in her articles.
Karen Kingston 3hours 16mins in on Stuftung Corona Ausschuss Corona Foundation Committee
https://gettr.com/streaming/p1fkn69b5ff
Really interesting details
Jonathan Weissman
@AllTheRisks
Documenting #AllTheRisks with the current experimental mass vaccination campaign across toxicology, molecular biology, virology, immunology and epidemiology.
Augusto Roux volunteered for Pfizer’s clinical trial. Did you know Pfizer hid his clinically confirmed diagnosis of pericarditis? How can you trust ANY data Pfizer supplied the regulators?? #AllTheRisks Full video available at http://alltherisks.com. Video banned from YouTube!
https://twitter.com/AllTheRisks/status/1540493046034432000
Jonathan Weissman
@AllTheRisks
·
3h
Sources.
@DrDavidHealy
, Dr David Healy. Disappeared in Argentina. https://davidhealy.org/disappeared-in-argentina/
@joshg99
, Dr Josh Guetzkow. Is Subject #12312982 the Key to Proving Pfizer Vaccine Trial Fraud? https://jackanapes.substack.com/p/is-subject-12312982-the-key-to-proving
Good Stuff, Jonathan..
The UK Health Security Agency is ‘Seek(ing) Us Out ‘
Home News Clinical areas Respiratory GPs asked to seek out immunosuppressed who have not had spring Covid booster
GPs asked to seek out immunosuppressed who have not had spring Covid booster
Emma Wilkinson
17 June 2022
NHS England has asked GPs to run searches for immunosuppressed patients who have yet to have their ‘spring’ Covid booster jab.
It said this formed part of additional ‘urgent steps’ needed, alongside asking GPs to send invites to those who have not yet had a fourth dose, and discussing vaccination and booking appointments with eligible patients during routine clinical care.
A PRIMIS search developed by the UK Health Security Agency and now available in GP IT systems should be used to identify patients, NHS England said in a letter.
As it is not possible to run a national search for eligible individuals, the letter said, NHS England needs GP practices to help find those who have not yet had the spring booster.
But the search is a non-exhaustive list and local searches may also be needed to find additional people not listed due to issues with coding, it said.
If they have not already done so, practices should contact those identified by the search function or local searches of their registered list to offer the booster jab by 27 June.
Practices that have not signed up to the Covid-19 vaccination enhanced service should share a list of eligible patients identified through the searches with the CCG by 23 June, the letter added.
The letter, which thanked GPs and their teams for their support in vaccination, also said the current immunosuppressed cohort list is scheduled to be updated by 17 June.
It comes as the latest surveillance data from the UK Health Security Agency suggest Covid-19 activity is increasing nationally.
Covid 19 makes an encore to go along with Moneypox on pg14
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1085050/NOIDS-weekly-report-week24-2022.pdf
Dr Josh Guetzkow. Is Subject #12312982 the Key to Proving Pfizer Vaccine Trial Fraud? https://jackanapes.substack.com/p/is-subject-12312982-the-key-to-proving
Shame he didn’t clock this as Susanne and Tim did and the seriousness of it.
“The entry states that Augusto had an adverse event of severe anxiety starting on September 23. Dr Polack described this anxiety as not caused by the vaccine, described Augusto as suspecting a conspiracy (between the two hospitals), his anxiety as constitutional, and the ‘volunteer’s’ condition as persisting as he had now taken the matter to ANMAT.
On October 11, there is a further entry by Dr Polack saying that he should have recorded all this on September 23 but he had now transferred his October 8 entry into the ‘volunteer’s’ medical record. This is a note stating that essentially the ‘volunteer’ developed a severe mental illness on or around September 23 and that this was not caused by the vaccine.
There is nothing in any record that indicates that Dr Polack or any other doctor attempted on September 23 to establish whether Augusto had a mental disorder. Augusto points to the notes of October 8 and 11 as evidence that this idea was invented just around the time the ANMAT Hearing was about to happen.”
https://davidhealy.org/disappeared-in-argentina/
https://davidhealy.org/disappeared-in-argentina/#comment-222188
Argy-bargy…
In a stunning irony, Akathisia appeared on Stopping Antidepressants. This insertion was purely down to the appearance at Conference of Wendy Dolin, along with Kristina Kaiser, who travelled from the US to give a presentation on the invitation of Wendy Burn.
Symptoms of antidepressant withdrawal
If you do get any of the symptoms listed below, tell your doctor.
You may notice:
a feeling of inner restlessness and inability to stay still (akathisia).
Produced by the RCPsych Public Engagement Editorial Board.
https://www.rcpsych.ac.uk/mental-health/treatments-and-wellbeing/stopping-antidepressants
Suicide Prevention, Louis Appleby admitted to Dee Doherty in correspondence, that is freely available, that he was aware of Akathisia, but the ‘Government did not want to make changes.’
The RCP Conference this time round has emphasis placed on the safe and effectiveness of antidepressants and other drugs. It threw no relief and had an almost fortress-like appearance to sway-forth exactly where they stood, together.
This conference laid-bare the profound movement to keep all dangers under wraps. It flies in to opposition of real evidence. It was a demonstrably ‘take that’ approach and spoke volumes. It was fiendishly amateurish and out-of-touch.
There has to come a point where this Royal College has gone way too far in its blatant obstructions. Where they cannot continue to rule their roost and put lives in jeopardy.
They have to be called out and may be in time that could involve a legal challenge for the increasing rise in deception.
So proud of @Wesselyas he is admitted as a new Fellow to the Royal Society today – one of only 6 psychiatrists to have become so in more than 400 years. #soproudofyou
There are some people, no matter how much harm has been inflicted, who carry on regardless, covered in garlands … 400 years a slave.
“So proud of @Wesselyas he is admitted as a new Fellow to the Royal Society today – one of only 6 psychiatrists to have become so in more than 400 years. #soproudofyou
There are some people, no matter how much harm has been inflicted, who carry on regardless, covered in garlands … 400 years a slave.”
Imagine him and Burn’s in a psychiatric hospital with akathisia being pumped full of more drugs to treat their ‘mental illness’
Getting all geared up for psychosis and total surveillance.
“Zuckerberg envisioned experiences in the metaverse to be more immersive than text, photos, or videos, noting that people can even make eye contact when meeting in the metaverse. The technology “basically adds up to making it deliver this realistic sense of presence,” the Facebook co-founder added.”
https://news.bitcoin.com/mark-zuckerberg-expects-billions-of-people-to-use-the-metaverse-generating-massive-revenue-for-meta/
“We hope to, basically, get to around a billion people in the metaverse doing hundreds of dollars of commerce each,” he continued, adding that people could be “buying digital goods, digital content, [or] different things to express themselves” in the metaverse.
Some examples of what people can purchase are “clothing for their avatar or different digital goods for their virtual home or things to decorate their virtual conference room,” Zuckerberg listed. He added that people can also buy “utilities to be able to be more productive in virtual and augmented reality and across the metaverse overall.”
Plenty new work for the psychiatrists spying on everyone and ‘treating’ them. Talk about harmatology…
James Roguski on the FDA meeting today, what’s going to happen….
https://rumble.com/v1a7u8q-james-roguski-fda-meeting-on-next-round-of-boosters.html
Toby Rogers – FDA Abandons Science on Covid Shots
https://rumble.com/v1ad489-toby-rogers-fda-abandons-science-on-covid-shots.html
I hope some clips make it online.
So I’ve just seen this:
https://worldcouncilforhealth.org/resources/spike-protein-detox-guide/
Although Dr Tess Lawie gives an important safety warning about St John’s Wort. I don’t think it should be on there at all as it can induce suicide and violence up to homicide, as everyone on here – and few others else where including doctors – know: it induces AKATHISIA. Also on here everyone knows the problem with doctors advice once someone has the beginnings of akathisia – They make it worse with more psych drugs being as it’s seen as ‘mental illness’ – usually severe anxiety and agitation. When presenting at A&E hospital they will go to the loo a lot and pace around saying they feel suicidal. A letter goes to the GP and a life long label is given which usually gets worse with the ‘treatment’. When the whole thing started with someone taking very well intentioned generally good advice.
Josh Guetzkow @joshg99
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One of the few true journalists out there today.
Maryanne Demasi, PhD
@MaryanneDemasi
My latest investigation @bmj_latest
Experts say that drug regulators which are largely funded by the very industries they are sworn to regulate are prime examples of “institutional corruption”
https://bmj.com/content/377/bmj.o1538.full?ijkey=jPIowyCkUJwciSR&keytype=ref…
@DrJBhattacharya @JanJekielek @MartinKulldorff @MartyMakary
From FDA to MHRA: are drug regulators for hire?
BMJ 2022; 377 doi: https://doi.org/10.1136/bmj.o1538 (Published 29 June 2022)Cite this as: BMJ 2022;377:o1538
Maryanne Demasi, investigative journalist
https://www.bmj.com/content/377/bmj.o1538.full?ijkey=jPIowyCkUJwciSR&keytype=ref
“It’s the opposite of having a trustworthy organisation independently and rigorously assessing medicines. They’re not rigorous, they’re not independent, they are selective, and they withhold data. Doctors and patients must appreciate how deeply and extensively drug regulators can’t be trusted so long as they are captured by industry funding.”
https://twitter.com/MaryanneDemasi
Dr Robert Malone – MSM Is An Arm Of Propaganda For The Pharmaceutical Companies and references Maryanne Demasi From FDA to MHRA: are drug regulators for hire? in BMJ at the end
https://rumble.com/v1ari09-dr-robert-malone-msm-is-an-arm-of-propaganda-for-the-pharmaceutical-compani.html
https://www.dailymail.co.uk/news/article-10979601/Copenhagen-shooting-Police-say-no-indication-attack-act-terror.html
“He uploaded several playlists to YouTube entitled ‘Killer Music’ and ‘Last Thing to Listen To’, writing underneath that ‘Quetiapine does not work’.
Quetiapine is a powerful anti-psychotic medication that is used to treat schizophrenia, bipolar disorder and major depression. It can also be used to treat drug addiction. ”
Yeah but it’s very good a causing AKATHISIA which induces violence up to homicide.
For those new to this from the vacine horror department. Quetiapine is also used at high dose 400mg for anxiety and insomnia in psychiatric hospitals which is usually coerced and if that fails it is forced upon the patient by sectioning and if necessary held down and injected.
I can only hope Dr Healy is called as expert witness to get to the root if this latest horror show.
Edward Dowd
@EdwardDowd
‘Friday Roundtable’ Exposing the Fraud With Edward Dowd
https://rumble.com/v1ar9nc-friday-roundtable-exposing-the-fraud-with-edward-dowd.html
“This is about convincing the marginal mind”
“Its the battle for the marginal mind”
“The evidence is in…you can’t claim you didn’t know…its the fraud to end all frauds” …