June Raine featured in the international media last week as the public face of Britain’s MHRA (drugs regulatory agency) when they became the first agency to license a Covid vaccine. A journalist, who had unearthed a letter of mine from 20 years ago, got in touch with me asking to talk by phone about whether I would be confident about JR’s claims that we all could have confidence in the vaccine. We never got to talk.
Dr June Raine, Director of
Post-Licensing Division, MCA
Market Towers, 1 Nine Elms Lane
LONDON SW8 5NQ
7 June 2000
Dear Dr Raine,
You may or may not have heard that yesterday in Cheyenne, Wyoming a Court found Glaxo SmithKline guilty on several accounts including the count that Paroxetine can cause suicidality, that it specifically did so and contributed to the wrongful death of Don and Rita Schell as well as Deborah and Alyssa Tobin and that the company had been responsible for a failure to test and a failure to warn. You may also be aware of a verdict in the Hawkins case in New South Wales some weeks ago where a Supreme Court Judge made it clear that in his opinion Mr David Hawkins would not have murdered his wife but for the influence of Sertraline.
In the course of my work as an expert witness in Tobin versus SmithKline I got the chance to look at SmithKline’s healthy volunteer database in Harlow. Their characterisation of this for you was that: “There were no reports of suicidal thoughts in any of the volunteer studies. There were few reports of ’emotional lability’, however these reactions were not found to be related to suicidal thoughts or behaviour. Some volunteers reported anxiety, nervousness and agitation while taking paroxetine, however the most commonly reported adverse events were nausea, diarrhoea, drowsiness and insomnia”.
What I found was that approximately 25% of the volunteers in the studies that I reviewed which were all of the healthy volunteer studies done prior to the filing of this drug for registration in the US and in the UK – 34 studies approximately in all. These yielded a 25% agitation, nervousness/akathisia rate. Some of the multiple dose studies in healthy volunteers lasting 2-3 weeks yielded an up to 85% withdrawal rate in the volunteers.
All of their healthy volunteer studies were supposed to have been made available to me but not all were. Of the ones that were missing there was trace correspondence left in once indicating that the investigator had never witnessed such a level of problems in a study with healthy volunteers. Another study was a single dose study which in a dose dependent fashion yielded a 75% rate of severe adverse events most of which involved the central nervous system. There were other disturbing indications from one of the other missing studies.
Volunteers who had participated in the programme went on to suicidal acts. The relationship between their intake of paroxetine and later suicidal acts is a matter about which neither you nor SmithKline Beecham should be sanguine.
These studies were for the most part done on company employees. None of the studies bar the missing ones were done by investigators with a background in psychiatry. The investigators were general physicians with a primary interest in gastrointestinal problems who could not have been expected to detect mental problems of this sort that have concerned me and I would have thought should concern you.
My testimony in this case also bore witness to sealed studies and other unreported data. It commented on the Montgomery Baldwin Study which yielded a projected rate of 45 suicide attempts in a group of recurrent brief depressive disordered patients on paroxetine per annum versus 12 on placebo. The figures were not statistically significant in great part one has to suggest because the company had terminated the study early. This termination and subsequent non-publication I would imagine the jury will have found and others will find significant.
[Addition Dec 2020: Montgomery was a member of the CSM-MHRA apparatus at the time licensing these drugs – see attached Montgomery Notes].
Dr Hudson, currently of the MCA, was a witness for SmithKline in this case. He may well be able to give you further details on some of the issues involved. His testimony involved repeated reference to the fact that SmithKline Beecham cannot decide whether their drug had caused problems such as the wrongful death of Don and Rita Schell or Deborah and Alyssa Tobin or the wrongful deaths of many other people whose deaths have been reported to SmithKline even when these reports have been accompanied by the opinions of their treating physicians that the drug had indeed contributed to the problem. Dr Hudson’s testimony was that until controlled trials or other similar studies had proven in general that paroxetine could cause such problems that the company could not make decisions on any specific case.
[Addition Dec 2020: Hudson left GSK in the midst of this trial and joined MHRA later becoming its CEO – succeeded now by June Raine].
This appears to me a Black Hole defence. It is entirely conceivable that tens of thousands of suicides could disappear into this Black Hole without either SmithKline Beecham, Pfizer or Eli Lilly being called upon to make any judgements as to whether their drug was contributing to the problem. The lack of evidence from randomised controlled trials or epidemiological studies in this context is not evidence of a lack of a problem. It stems explicitly from failures of SmithKline Beecham, Pfizer or Lilly to do the requisite studies. Both David Wheadon and Christine Blumhardt from SmithKline as well as Roger Lane from Pfizer and Charles Beasley from Eli Lilly along with outside experts such as Daniel Casey and John Mann have testified under oath in the course of the last year that there have been no studies undertaken by any of these companies or others that have been designed to test whether the SSRIs could cause a problem. I believe that this will in due course be seen for the extraordinary state of affairs that it is.
I think what will also be clear is that SmithKline Beecham recognised the presence of withdrawal syndromes in their volunteers from the early to mid 1980s. That withdrawal syndromes occurred at a much higher rate than occur on benzodiazepines. Nevertheless they applied for and have received from you and other regulators a licence to claim that their drug is effective in the prophylaxis of depression and these claims have been based on designs which almost certainly are designs better suited to show the presence of a withdrawal syndrome than designs suited to demonstrate prophylaxis in depressive disorders. A great number of people have in recent years been told that when they begin to feel ill on discontinuing treatment that this is the recrudescence of their mood disorder rather than a discontinuation syndrome from their drug. I would imagine that a great many such people and others on their behalf will feel extraordinarily let down and angry when faced with the evidence that I’ve been faced with.
David Healy MD FRCPsych
Director, North Wales Department of Psychological Medicine
A copy of the Original Letter is Here.
Copyright © Data Based Medicine Americas Ltd.
.The UK is in deep trouble having to rely onthe MHRA as your letter reveals Goodness knows why Faucci in the USA could be intimidated into withdrawing his criticism of them recently On TV he criticizised the speed of approving vaccines – next day stating it was a misunderstanding – as if people couldn’t see through them. Trust is not a word June understands – first comes the truth.
A ressuring video from June with nice but firm lady voice She’s missed out the bit about the advertisment she put out in nov. Might scare more people and create even more mistrust more than they have already Over 50% are said by polls to mistrust the way Covid is being handled . The MHRA included
In MayHome > News and events > Press releases 2020 > May 2020 > Site launched for reporting of COVID-19 treatment side effects
The Medicines and Healthcare products Regulatory Agency (MHRA) launched the new online reporting site this week dedicated to reporting any suspected side effects or incidents related to any treatment options connected with COVID-19.
7 May 2020
The named Yellow Card COVID-19 reporting site aims to monitor the safety of healthcare products being used in COVID-19 treatment.
Both healthcare professionals and patients are encouraged to use the site to report any suspected side-effects from medicines, future vaccines and incidents involving medical equipment relating to COVID-19 treatment.
The MHRA says on its website that the launch of the reporting site means that there will be rapid identification of new or emerging risks connected with COVID-19 medication and treatment, which might not have been previously known about.
MHRA chief executive Dr June Raine stated:
“I encourage healthcare professionals and patients to use our new dedicated site to report problems with medical equipment, including ventilators or testing kits, as well as any suspected side effects from medicines used to combat COVID-19.”
Leigh Day product safety partner Jill Paterson commented:
“As the COVID-19 virus has spread across the world in just three months, so the response of science and technology has by necessity been urgent. It is therefore vital that the necessary safeguarding measures are equally as strong.
“It is positive to see that measures have been quickly taken to ensure that all of the new developments in medicine, treatments, tests, vaccines and ventilator equipment are being monitored by the responsible body, the MHRA.
“We encourage patients and health professionals alike to make good use of the Yellow Card COVID-19 reporting site.” Knwing full well what a disgraceful farcical con the yellow card is.
Then in Nov has to come clean about the number of adverse events expected No mention on the video or previous announcements
PRESENTED BY: HEALTHCARE IT NEWS & HIMSS MEDIA
AI Powered Healthcare
UK turns to AI to monitor reactions to COVID vaccines
According to officials, the need for a powerful tool to sort through what may be significant numbers of adverse reactions speaks to the scale of the COVID vaccination effort.
Jeff Rowe |Nov 04, 202001:46 pm
Public health officials around the world are waiting for at least a vaccine that will help them battle COVID-19. But given the speed with which tentative vaccines are being developed, officials are looking for ways of monitoring and responding to potential adverse reactions once any vaccine is being given to the general public.
In the UK, for example, the Medicines and Healthcare Regulatory Authority (MHRA) has paid a software company to develop an AI tool to “process the expected high volume of Covid-19 vaccine adverse drug reaction (ADRs) and ensure that no details . . . are missed”.
As the UK’s Financial Times puts it, “the need for a powerful tool to sort through what are forecast to be a huge numbers of adverse reactions, speaks to the scale of the vaccination program in the months ahead.”
In addition to the scale, many of the vaccinations being developed are new, which means that even after clinical trials there will be plenty of questions about the reactions of potentially millions of people.
“You’re talking about vaccines that have potential liabilities, it’s an unknown unknown,” said Gary Nabel, chief scientific officer at pharmaceutical company Sanofi, which is currently working on two Covid-19 vaccine candidates. “As big as a 30,000-person trial is, when these go out into the world of millions of people, things will happen.”
Indeed, Nabel cited one famous vaccine developer, Maurice Hilleman, telling him, “every time I launch a new vaccine, I hold my breath for the first 30m doses”.
According to the MHRA, based on previous vaccination campaigns, they expect between 50,000 and 100,000 reports of suspected side effects for every 100m doses over a 6-12 month period.
“The AI tool will be employed as part of the MHRA’s yellow card scheme for coronavirus, through which patients and healthcare professionals report suspected side effects and negative reactions. These are then evaluated to identify where updated advice or regulatory interventions are needed to protect the public.”
Noting that the scale of its Covid-19 vaccination campaign wiill be much larger than any past adult program, the MHRA said the absence of an AI tool would “hinder its ability to rapidly identify any potential safety issues . . . and represents a direct threat to patient life and public health”.
According to FT, Mr Nabel and other experts consider the move by the MHRA a positive sign of proactivity by the UK’s regulator.
So Where is Hudson now? Ian Hudson
Senior Adviser, Integrated Development, Bill and Melinda Gates Foundation
London, England, United Kingdom 500+ connections Contact info
The Bill & Melinda Gates FoundationLanguage
OUR GOAL: to strengthen regulatory systems and expedite the development, regulatory approval, and manufacturing of innovative new drugs, vaccines, diagnostics, and devices that advance global health.
The time it takes for a novel idea or discovery to result in a viable global health product can be years, even decades. Numerous obstacles stand in the way, from the time-consuming clinical trial stage to the regulatory approval process and the search for cost-effective manufacturing options. Lack of access to other researchers’ data can also stymie efforts to innovate and can lead to repetitive efforts and inefficiency.
We serve as a “solutions shop” within the foundation to help troubleshoot complex challenges across all stages of the product development process, in areas ranging from regulatory planning and policy to clinical trial design and manufacturing.
We work to reduce the time needed for novel medical products to gain regulatory approval so they can more quickly reach the people who need them most.
We create platforms for knowledge sharing and collaboration so researchers can analyze large amounts of data from widely dispersed sources and get to insights and discoveries faster.
We support the development of technologies that facilitate drug discovery, low-cost drug manufacturing, and drug delivery.
Our Integrated Development strategy is led by Dan Hartman and is part of the foundation’s Global Health Division.
If product development processes can be made more streamlined, life-saving products can more quickly reach the people who need them most. The Integrated Development team was formed in 2012 to address shortcomings in the product development and regulatory ecosystem in order to better serve the foundation’s global health programs, our partners, and the global health community at large.
The Integrated Development program serves as a “solutions shop” within the foundation to help troubleshoot complex challenges across all stages of the product development process, in areas ranging from planning and clinical trial design to manufacturing and regulatory approval. This includes providing guidance on evaluating drug and device candidates at predetermined points in the development cycle to inform go/no-go decisions related to efficacy, risk, cost, and other factors. We also create platforms for knowledge sharing and collaboration so researchers can analyze and interpret large amounts of data from widely dispersed sources and get to insights and discoveries faster.
Strengthening Regulatory Systems
Data Analytics for Decision Making
Chemistry, Manufacturing, and Controls
Strengthening Regulatory Systems
The push to improve global health depends on having reliable sources of high-quality medical products—including vaccines, drugs, and diagnostics—at prices that are affordable for people in developing countries. Many of those countries, as well as multilateral organizations such as Gavi, UNICEF, and UNITAID, require that the medical products they buy meet standards set by the World Health Organization (WHO).
We work to reduce the time needed for a novel medical product to achieve WHO prequalification and other regulatory approval, by taking the guesswork out of the process and fostering an ecosystem in which products can more quickly proceed through the regulatory pipeline. We also strive to improve monitoring and surveillance of medical products after they have been licensed for use, in order to identify any adverse reactions.
Data Analytics for Decision Making
We provide data analysis support to other foundation programs and to our partners and grantees to inform their decision making. One key effort is an initiative that integrates massive amounts of existing data—covering 12 million children in 34 countries—about risk factors affecting birth, growth, and neurodevelopment. Researchers can analyze this data set to generate insights and facilitate rapid progress.
We apply this same data-driven approach to our model-informed drug development platform and our dose-selection platform for vaccines and therapeutic drugs. Another key initative is our support for data collection and research on infecting Aedes aegypti mosquitos with Wolbachia bacteria, which renders them less able to transmit dengue, chikungunya, and Zika. Other projects include support for development of long-acting oral and inhaled drugs, including contraceptives.
Chemistry, Manufacturing, and Controls
We provide technical expertise to other foundation programs on manufacturing, delivering, and seeking regulatory approval for drug candidates, with the aim of accelerating timelines and increasing the probability of success. We also work with the foundation’s country offices to facilitate partnerships with low-cost regional manufacturers and invest in promising low-cost manufacturing technologies. In addition, we make grants to support the development of technologies that aid in drug discovery and low-cost drug manufacturing and drug delivery devices.
Today very frail and elderly people with many health conditions will be given a vaccine which hasn’t been properly trialed or regulated. Are they being cared for or being used in a mass experiment by corrupt inept networks who seemed more concerned to boast about being first than protecting all citizens. As one European spokesperson said – this is not a competition or a game of football – we are all in this together = seems not.
David Phizackerley has a background in evidence-based prescribing and therapeutics. He trained as a pharmacist and has worked in primary and secondary care. For many years he provided advice and support to GP practices on cost-effective, rational prescribing. Since 2009 he has been Deputy Editor of Drugs and Therapeutics Bulletin
D P publicly stated very serious concerns tonight about the way the Covid vaccines are being handled in UK – at 34:34 on iPlayer
Duration40 minsFirst shown10:45pm 7 Dec 2020Available for 29 days
D P’s concerns included that there is a lack of data; no public data dossier available; no information leaflett being given to people before being vaccinated – therefore no way of making informed consent. That Drs are not able to answer questions being raised by people considering vaccination including there is no data available for sub groups in the population eg those who have already had the disease have not been included in trials, He said there is a need for comparative data for different vaccines which is not available and significantly – considering that Faucci in US had strangely made a rapid retraction of his criticism of the UK regulators recently , Faucci had proposed this back in the Spring but no agreement was reached regarding the protective effect. Ended with a statement by government minster that the MHRA is world leader and from the MHRA that they are advised by
The Commission on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products.
CHM is an advisory non-departmental public body, sponsored by the Department of Health and Social Care.
“I would imagine that a great many such people and others on their behalf will feel extraordinarily let down and angry when faced with the evidence that I’ve been faced with.”
I can still remember going through withdrawal induced suicidal horror.
i sensed to share this with someone who had prescribing priveleges would be mistake.
Yet I confided in the local family pharmacist …..i just dont know whats wrong with me, ive never felt this way before, i just want to …..
The pharmacist leaned forward and whispered, ‘i’m not supposed to tell you this but i want you to know that its not you, its the drug! ‘
That was the moment the lightbulb went on. Of course it was how could i have been so ignorant!! Of course it was!!
As i drove home that day the humiliation, horror and betrayal that flooded over me will never be forgotten. It was then 6 years of being unemployed and unemployable while i fought to survive each day.
Thankyou Dr Healy for all the brillantly written truth telling letters you have sent out. How people in positions of responsibility just do nothing when confronted with the truth is beyond my understanding.
I cant help but feel Trumps response to covid deaths ‘it is what it is’ seems to be the medical professions response to ssri harm. The medical profession should be deeply ashamed!
“MHRA should ensure Pfizer puts the raw data on the vaccine trials in the public domain. Trust has to be earned and not taken for granted. This starts with transparency and publishing all the data now.”
Had to smile at this….. what chance.
25mins in – BBC Interview with Allyson Pollock Director of the Institute of Health and Society, Newcastle University.
“If you look at the information sheet for the tests the government has been using – and they have spent billions of pounds on these tests – they say they are not to be used on healthy people with no symptoms, there not tests of infectious disease they are only to be used as a support for doctors who are making a clinical diagnosis. In other words, in people with symptoms.” It’s hugely unethical this experiment. It’s rolling out these that have never been validated for use in the community and used on healthy well people. And it’s spending billions of pounds on this project and it’s why it needs to stop.”
In Dr’s Karina Reiss an Sucharit Bhakdi’s book Corona False Alarm facts and figures page 111 under mRNA vaccines the last two words are: “simply terrifying”.
As for our Govt knowledge of the RT PCR test – they describe it as: real time PCR test
Someone should tell them RT stands for:
We certainly need to reverse this massive operation of brain washing insanity.
Swimming down the Hudson River…
Dear Dr Raine,
Our Ref: DH/JT
I wrote to you almost half a year ago on issues to do with suicidality and SSRIs as well as physical dependence on SSRIs. I followed up the original letter a month later enquiring about the review of healthy volunteer studies that the MCA/CSM were scheduled to undertake in July of this year.
I haven’t had a reply to either letter.
Tuesday, March 27, 2007
Dr June Raine, MHRA knew 7 years ago!
Social Audit Ltd
Correspondence with J. Raine
The terms of reference of the SSRI Working Group duck the most important issues: could this crisis have been avoided, and what might now be done to avoid similar problems in future?
For the record, our view is that the regulators themselves played a major part in creating the problems now being addressed. We believe that nothing short of a thorough overhaul of the drug safety monitoring system is essential and that comparable problems will arise in future unless and until that is done.
The present crisis has been looming for years (Teicher et al., 1992; Healy 2003; Medawar 1994, 1997). We believe the regulatory response was inadequate for three main and related reasons: over-reliance on misleading definitions and on data represented as ‘scientific’ and reliable, at times to the point of defying logic and common sense; a chronic tendency to marginalise, dismiss or ignore critical comment; and inadequate, sometimes incompetent analyses of the available data.
P.S. I wasn’t joking about the FAX machine; while receiving your letter it choked and then expired. I’d be grateful if you could use email instead.
The more we read, the more frightening it gets. I guess we could say that about most matters – but this is to do with our lives. Here in the UK everything is going swimmingly – or so we would believe if all we did was listen to the news or read the papers. We have been so clever, we’ve managed to be the first to use a vaccine. This morning, a 90 year old lady has been interviewed widely because she is the first person IN THE WORLD, apart from the trials guinea pigs, to have a Covid vaccination. “Excellent news” they all report – why can’t they just stop and wonder whether we’ve actually been conned into being the “first in the world” in this event? It’s happened because “we’re smarter than many other countries”, cried one Cabinet member and there’s even talk of the PM being inoculated live on TV. “Even the Queen is up for the jab” they shout – “and she’ll tell you so after she’s had it”.
Oh dear, I thought we’d gone through the worst that 2020 could throw at us but I guess that looking towards 2021, we fare no better! “We’re at the beginning of the end” is another quip coming our way – I only hope that that phrase doesn’t hold a sinister truth for mankind.
Here in Wales, we cannot even get the calls for ‘home testing kits’ sorted to a decent standard. I was advised by a GP Nurse that I needed to apply for such a kit. I had a bad chesty cough – a regular winter occurrence – for which I suggested that I possibly needed an antibiotic or a course of steroids to strengthen my lungs ( for the fight against Covid should it come my way!). Oh yes, I needed a course of antibiotics and a Covid test. I would need to self-isolate from that moment until I received a negative response to the test. Phoned the appropriate number only to be asked did I have a high temperature – no, a sustained very dry cough – no, then why did I think I should be tested? She really couldn’t send out a kit without the expected symptoms. Explained in full. We eventually agreed that a kit would be sent and would be with me within two days. Did I need to self-isolate whilst I wait – no, not until I did the test apparently.
That was last Wednesday – I am still waiting for its arrival! Phoned them again this morning – there is nothing they can do to chase up a non-arrival; did I need a new order made out – do I still have “the symptoms”! I AM NOW FREE TO ROAM – as far as my country’s rules will allow me.
Have faith in the ‘system’? Not an easy ask!
Hi Mary – hope you’re feeling better if not thanks to NHS in Wales…the energy required to get what you needed would put of lots of people while Covid is raging around Wales.
Vitamin D seemed to be flavour of the month for a few weeks I decided it won’t hurt to take a supplement myself. England is to get free deliveries for vulnerable people – not so in the dark days of Wales it seems….
This site is intended for health professionals only
Millions of vulnerable people to receive free Vitamin D deliveries
28 November 2020
The Government is offering millions of vulnerable people in England free supplies of Vitamin D for the winter.
Around 2.7m clinically extremely vulnerable individuals and care home residents are set to receive the deliveries.
The Department of Health and Social Care (DHSC) said this is because they are at higher risk of suffering from a Vitamin D deficiency, due to spending more time indoors this year as a precaution against Covid-19.
Making the announcement today (28 November), the DHSC clarified that care homes will automatically receive provision. However, it will send invitations to individuals considered clinically extremely vulnerable to Covid to ‘opt in’ for a supply to be delivered directly to their homes.
The deliveries, lasting from January until May, will be free of charge. The aim of the winter supplements is to support health in general, but particularly of the bones and muscles.
It comes as health secretary Matt Hancock has asked NICE and Public Heath England (PHE) to again review the evidence so far on the relationship between Vitamin D and Covid. The findings are expected at the end of this year, but researchers currently investigating the link require larger-scale trials.
The Scottish Government has previously advised vulnerable people shielding from the virus to take a daily supplement of the vitamin.
Commenting on today’s news, Mr Hancock said: ‘The Government is taking action to ensure vulnerable individuals can access a free a supply to last them through the darker winter months. This will support their general health, keep their bones and muscles healthy and crucially reduce the pressure on our NHS.
‘A number of studies indicate Vitamin D might have a positive impact in protecting against Covid-19. I have asked NICE and PHE to re-review the existing evidence on the link between Covid-19 and Vitamin D to ensure we explore every potential opportunity to beat this virus.’
PHE currently advises everybody to take 10mcg of Vitamin D a day between October and early March.
Meanwhile, a Spanish study earlier this month suggested that more than 80% of hospitalised Covid patients have a Vitamin D deficiency.
Just a little follow up, Susanne. In the last phonecall mentioned in my comment above, I asked what I should do if the test eventually showed up. The answer was to dispose of it as we wouldn’t know where it had been during its travels. Plus the fact that I had no “covid symptoms” therefore no need for a test.
A few days later a package was delivered. I had, by then, forgotten all about the lost kit – but, lo and behold, here it was, having started its journey on December 3rd. as promised. It was now the 10th of December. Guess where it had come from? AMAZON! I was shocked. It seems then that we, UK as a whole I guess, are now paying Amazon to deliver these kits!
I had a read of the instructions ( a glossy booklet affair!) before binning. Good grief, it was enough to frighten the toughest individual. Should I use it, I had to take it to a registered post office ( known by its covid signage apparently) no earlier than one hour before collection from that office; I was to speak to noone on my way there or back; I was to walk as quickly as possible to avoid contact and to self-isolate until the results came through and under no circumstances should I leave the house until a negative test result was received!
Thanks for your concern Susanne – I am fine thank you, still have my chesty cough but that’s not unusual. During normal times I would not have contacted the GP surgery about it, I often manage to clear it up simply by letting it run its course. This year, things being so far from normal, I felt the need to make sure that my chest was as clear as possible just incase of Covid. I should have known better!
This is exactly what happens when in their haste to jab everyone, questions are not asked –
Why put two potential candidates for a side-effect through this when had they been asked, the jab should have been refused –
They will now investigate these cases in more detail to understand if the allergic reactions were linked to the vaccine or were incidental.’ –
expert reaction to reports of allergic reaction in two healthcare workers who had a history of serious allergies and who received the Pfizer COVID-19 vaccine
‘We know from very extensive clinical trials that this wasn’t a feature,’ she said.
Patrick D Hahn
#GlaxoSmithKline claimed #Paxil was safe and effective for treating major #depression in adolescents. Their own data showed otherwise. #Study329
Great Book, Patrick – Punchy, Direct, Evidential –
Shoot First, Ask Questions Later –
Statement from Pfizer UK:
“We have been advised by MHRA…
From Public Citizen – a petition in the US:
Yesterday, a 90-year-old British grandmother named Margaret Keenan became the first person in the world to be given a coronavirus vaccine outside of a clinical trial.
On the same day, Donald Trump conducted a self-aggrandizing publicity stunt in the form of issuing a ludicrous executive order that attempts to compel manufacturers to prioritize vaccine access in the U.S. before working with other countries.
Of course, Trump is pushing a false — and immoral — choice.
The people of the world are all fighting the same virus, which doesn’t know an American from a Zimbabwean.
Instead of pitting us against each other, the President of the United States should be advocating global access to vaccines.
The fact is the U.S. government has the power and resources to expand the supply of vaccines everywhere — by scaling-up manufacturing, sharing technology with the World Health Organization, and teaching the world to make safe and effective vaccines.
That would help shorten the pandemic, save lives, and restore jobs. And not just in America, but around the world.
Urge President-Elect Joe Biden:
If we don’t share the vaccines, we know what’s going to happen. It will take years for people in poor countries to get access. Tens or hundreds of thousands will die needlessly. But if we end corporate monopoly control and share the technology with qualified manufacturers around the world, we’ll quickly have enough to vaccinate everyone on the planet.
It’s a crazy world. Great to see your book is still on sale Laurie
Goodreads helps you keep track of books you want to read.
Start by marking “Crazy And It Was: Surviving the Corporate Pharmaceutical Corruption of Western Medicine” as Want to Read:
Want to Read
Crazy And It Was: Surviving the Corporate Pharmaceutical Corruption of Western Medicine
Want to Read
Rate this book
1 of 5 stars2 of 5 stars3 of 5 stars4 of 5 stars5 of 5 stars
Crazy And It Was: Surviving the Corporate Pharmaceutical Corruption of Western Medicine
by Laurie Oakley (Goodreads Author)
4.75 · Rating details · 8 ratings · 6 reviews
CRAZY AND IT WAS is a frighteningly compelling, multi-layered story of one individual’s lost years in the prescription drug-saturated medical and mental health care systems. The book details how corporate forces are influencing healthcare decisions for the millions who take the advice, “talk to your doctor.” The author, who is no conspiracy theorist and still relies upon medication, shows through her own research, medical records and journal entries, an up close and personal account of how and why these systems alarmingly fail so many whom they aim to help. Written solely for her own catharsis, this page turner is also an eye-opening source of information for anyone reexamining the widely-pervasive, social assumptions regarding the reliability of pharmaceuticals and the systems that bring them into our lives.
How much stock should one place in the strategically used phrase, research shows…
Research shows that the prescription pain-reliever, Vioxx, is a safer alternative to aspirin, yet Vioxx was withdrawn from the market in September of 2004 after leading to at least 88,000 heart attacks and strokes, and after contributing to the deaths of an estimated 38,000 individuals.
Research shows SSRI anti-depressants like Paxil and Zoloft are safe and effective treatments for depression, yet there have been an alarming number of suicides connected with the drugs, one of many known side-effects that have been repeatedly downplayed by drug manufacturers.
And now, “new and exciting” research shows that a freshly patented anti-anxiety medication similar to Klonopin holds promise for treating autistic behaviors even though a key benzodiazepine researcher, more than thirty years ago, called for follow-up studies to confirm or rule out suspected brain damage for millions who had suffered after taking the drugs. Those studies have yet to be undertaken.
The science-as-sales-tactic, research shows, delivered a bill of goods to returning college student and single parent, Laurie Oakley. One she never bargained for. Anti-depressants prescribed by her general practitioner were the gateway drugs that landed her squarely into the mental health system where she continued to experience the side-effects of multiple medications, side-effects that were repeatedly misdiagnosed as a worsening mental illness. After even her medical doctors labeled her a hypochondriac while overlooking the side-effects of medications clearly listed in her chart, she decided to do some research of her own. She recovered her health, save for persistent insomnia that sent her back for more treatments. This time, when presented with medication treatments that she knew could cause harm, she would insist upon accountability. While her story may not manage a happy ending, she nevertheless closes on an unexpected high note. (less)
Thank you Suzanne!
One of the things that struck me about Public Citizen’s call was the idea of making this a ‘people’s vaccine’ since taxpayers funded it. I’m thinking that would have to entail full transparency and the passing along of the company’s so-called intellectual property.
Public Citizen suggests other scientists have access to Pfizer’s information so the vaccine can be manufactured and distributed more equitably.
This to me seems like the kind of taking back of power we have long been seeking. Might this open the way for more transparency generally? In the least it might cure (or if need be create) hesitancy since more eyes would be on the vaccine studies.
Psychiatrists and the pharma industry are to blame for the current ‘epidemic’ of mental disorders
142,934 views•11 May 2015 https://youtu.be/GlFbuqunb1I?t=9
with a challenge about the claim of the MHRA to be independant
Conflicts of interest among the UK government’s covid-19 advisers
BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4716 (Published 09 December 2020)
I dont undertand what the allergic response means? What were they allergic to ? So What is in the vaccine to trigger a dangerous response People should know so that they can protect themselves What if people are allergic to the vaccines alone ie not allergic already to anything they know about -and the vaccine alone triggers it off.
Can anyone explain please?
GP networks forced to pull out of delivering Pfizer vaccine due to new guidance
guidance putting plans at risk
10 December 2020
Exclusive At least one GP network has had to pull out of delivering the Covid vaccine next week because of new safety guidance, with PCNs around the country forced to urgently reconsider their plans.
This comes in light of new MHRA guidance stating that patients need to be kept for observation for 15 minutes following their vaccination with the Pfizer/BioNTech Covid vaccine to rule out anaphylaxis.
Around 280 PCNs were due to join the vaccination programme next week (15 December), after around 50 hospital hubs began vaccinating over-80s and at-risk hospital staff this week.
GPs within the North East Derbyshire PCN has been due to begin vaccinations from Thursday next week, however they have now had to stand down from administering the Pfizer vaccine due to the new guidance.
PCN clinical director Dr Steve Rossi told Pulse: ‘We have had to pull back, primarily but not solely due to the reintroduction of the 15-minute observation period, which makes our site unusable.
‘We are therefore standing down until there’s further guidance or if the AstraZeneca one comes in and doesn’t have that 15-minute observation – which we sincerely hope it doesn’t – then we’re confident that we can then get involved.’
He added: ‘The long and short of it was that even though there are lots of other questions with regards to how the whole thing’s going to work with call and recall, and booking, and the input from the CCG, the thing that really has been the nail in the coffin, certainly in the short term, is this 15-minute observation.’
Describing the decision as ‘disappointing’, with ‘all the work put in’, Dr Rossi stressed that the PCN wants to provide the vaccination ‘as locally as possible’ for its patients, but has to do this ‘safely and follow the guidance’.
He added: ‘We’ll be ready to stand up as soon as it is feasible.’
Nine PCNs in Kent which are due to start vaccinating patients from next Monday are also having to ‘rethink their plans’ due to the new guidance, Pulse has learned.
Kent LMC medical director Dr John Allingham said the MHRA’s new stipulations means that GPs will ‘have to slow down their clinics dramatically’, which is anticipated to be a ‘major problem’.
He told Pulse: ‘What I know already is that there are a number of practices who are having to completely rethink their plans.’
He said this comes as only some of the bigger venues can fit more than ten people into the waiting rooms.
He also pointed out that the new requirement will increase the number of staff required at vaccination sites.
Dr Allingham added: ‘Quite a few are practices and PCNs are probably going to make a loss on this’.
Kent GP Dr Yvette Rean, whose PCN had been due to start vaccinations next week, said on Twitter that her site now ‘can’t do it’.
However, she told Pulse that they were still in discussions with the CCG about how it could be made feasible.
The MHRA’s new guidance, which was published in full last night, followed news that two NHS staff suffered allergic reactions upon receiving the Pfizer vaccine on Tuesday – the first day of vaccinations in England.
.In thebmj ……… from 1 January 2021 (when) the MHRA will become responsible for handling all applications for new drugs and vaccines to be authorised in the UK.
rapid response 11 dec
FDA panel approved (and showed their working); EMA had a hack of a day in their security measures
Re: Vaccinating the UK: how the covid vaccine was approved, and other questions answered Elisabeth Mahase. 371:doi 10.1136/bmj.m4759
I apologise to those readers who may be annoyed by what appears to be my rolling commentary on the vaccine approvals but if the MHRA can do their work in similar fashion… (albeit in secrecy)
FDA’s advisory panel of experts voted to allow emergency use of Pfizer/BioNTech’s COVID-19 vaccine and the FDA is expected to authorise its approval (ref 1). Unlike UK’s MHRA, the FDA also released their working, the briefing document dated 10 December 2020 (created 7 December) (ref 2).
Does the FDA panel’s decision vindicate MHRA’s approval process?
Without adequate disclosure of their process, it is akin to saying you got the target number using numbers from a preselected collection on an episode of Countdown without showing your working: no cigar for MHRA, in my opinion.
Of further interest is the details of information provided to FDA by the sponsors of the vaccine.
The Phase III study for vaccine efficacy has 2 endpoints:
First primary endpoint: COVID-19 incidence per 1000 person-years of follow-up in participants without serological or virological evidence of past SARS-CoV-2 infection before and during vaccination regimen – cases confirmed ≥7 days after Dose 2
Second primary endpoint: COVID-19 incidence per 1000 person-years of follow-up in participants with and without evidence of past SARS-CoV-2 infection before and during vaccination regimen – cases confirmed ≥7 days after Dose 2
The protocol did not appear to specify the time or numbers threshold (duration after vaccination or cumulative numbers of positive cases) for interim analysis. In this case the sponsors appeared to choose the cut off date related to the FDA’s EUA (Emergency Use Authorisation) submission data cut-off date of November 14, 2020, and “as the entire enrolled study population had a median follow-up of less than 2 months” by this date, only those 170 confirmed COVID-19 cases by then are considered in the interim analysis as they would have been in the final efficacy analyses (page 17, ref 2).
I have no particular qualms about this decision by the FDA in handling the data, but it offers an interesting perspective upon the decisions made at MHRA.
There is no full briefing published by the MHRA detailing the evidence review that lead them to conclude in approval of Pfizer/BioNTech’s vaccine. However the limited inference so far from their document for health professionals (ref 3) showed the same total confirmed COVID-19 cases of 170, as in the sponsors’ press release as well.
If the MHRA document reflects the true limit of the access of data, this meant that the information that MHRA had reviewed was shaped by FDA’s 2 month median follow up rule as well as the EUA submission date (set arbitrarily) of 14 November 2020 rather than due diligence to getting as much data and information before MHRA is due to make their final determination.
Hence the statement from MHRA’s spokeperson that their vaccine approval is “on the basis of efficacy data submitted between 1 October and 2 December 2020” may well be factually correct in broad terms, but could have been misleading to suggest the possibility that efficacy data between 15 November and 2 December 2020 may have been considered by the MHRA.
The interest in the efficacy data of this vaccine is not simply limited to this forum; there In the bmj rapid responses 11 dec
is such an impetus to gain access to this information that hackers “unlawfully accessed” the vaccine document after a cyber-attack on European Medicines Agency (EMA).
It is uncertain what form of evidence or data was submitted by the sponsors to the EMA earlier this month and if it actually involved the same raw data demanded by the FDA process.
Judging by EMA’s previous performance in assessing RECOVERY trial data (ref 5), I am not certain the EMA will specifically ask for full raw data (as in FDA) and perhaps then the documents at risk of cyber hacking at the agency would not have provided more details than FDA’s own published briefings.
In the meantime, the other interesting piece of information is that “drug reviewers at the agency’s Committee for Medicinal Products for Human Use are scheduled to meet Dec. 29 to decide whether they have seen enough data to grant the shot a conditional approval” (ref 6). Obviously the pressure upon FDA’s reviewers is different from that on EMA’s.
Re Allergic Reactions –
DECEMBER 9, 202011:24 AMUPDATED 2 DAYS AGO
UK issues anaphylaxis warning on Pfizer vaccine after adverse reactions
By Alistair Smout
LONDON (Reuters) – Britain’s medicine regulator said anyone with a history of anaphylaxis to a medicine or food should not get the Pfizer-BioNTech COVID-19 vaccine, giving fuller guidance on an earlier allergy warning about the shot.
The Medicines and Healthcare Products Regulatory Agency (MHRA) said there had been two reports of anaphylaxis and one report of a possible allergic reaction since rollout began.
“Any person with a history of anaphylaxis to a vaccine, medicine or food should not receive the Pfizer BioNTech vaccine,” MHRA Chief Executive June Raine said in a statement.
“Most people will not get anaphylaxis and the benefits in protecting people against COVID-19 outweigh the risks… You can be completely confident that this vaccine has met the MHRA’s robust standards of safety, quality and effectiveness.”
Anaphylaxis is an overreaction of the body’s immune system, which the National Health Service describes as severe and sometimes life-threatening.
The fuller guidance, clarifying that the main risk was from anaphylaxis specifically, was issued after consulting experts on allergies. The MHRA had initially advised anyone with a history of a “significant allergic reaction” not to take the shot.
Pfizer and BioNTech said they were supporting the MHRA’s investigation.
Last week, Britain’s MHRA became the first in the world to approve the vaccine, developed by Germany’s BioNTech and Pfizer, while the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) continue to assess the data.
A top U.S. official said on Wednesday that Americans with known severe allergic reactions may not be candidates for Pfizer’s COVID-19 vaccine until more was understood about what had happened.
Canada’s health ministry said it would look at the reported adverse reactions in Britain, but said adverse events were to be expected and would not necessarily change the risk/benefit of the shot, after the country approved the vaccine.
MHRA chief Raine told lawmakers such allergic reactions had not been a feature of the Pfizer’s clinical trials.
Pfizer has said people with a history of severe adverse allergic reactions to vaccines or the candidate’s ingredients were excluded from their late stage trials, which is reflected in the MHRA’s emergency approval protocol.
However, the allergic reactions may have been caused by a component of Pfizer’s vaccine called polyethylene glycol, or PEG, which helps stabilise the shot and is not in other types of vaccines.
Imperial College London’s Paul Turner, an expert in allergy and immunology, who has been advising the MHRA on their revised guidance, told Reuters: “As we’ve had more information through, the initial concern that maybe it affects everyone with allergies is not true.”
“The ingredients like PEG which we think might be responsible for the reactions are not related to things which can cause food allergy. Likewise, people with a known allergy to just one medicine should not be at risk,” Turner told Reuters.
The EMA said in an email that all quality, safety and efficacy data would be taken into account in assessing the vaccine, including data generated outside the EU.
In the United States, the FDA released documents on Tuesday in preparation for an advisory committee meeting on Thursday, saying the Pfizer vaccine’s efficacy and safety data met its expectations for authorization.
The briefing documents said 0.63% of people in the vaccine group and 0.51% in the placebo group reported possible allergic reactions in trials, which Peter Openshaw, professor of experimental medicine at Imperial College London, said was a very small number.
“The fact that we know so soon about these two allergic reactions and that the regulator has acted on this to issue precautionary advice shows that this monitoring system is working well,” he said.
However, Gregory Poland, a virologist and vaccine researcher with the Mayo Clinic in Rochester, Minnesota, said that the MHRA and NHS had overreacted initially.
“I would not have broadened to the degree they did,” he said.
“It’s reasonable to let the world know about this, and to be aware of it in terms of people who have had reactions like this to vaccines. I think to say medicines, foods or any other allergies is past the boundary of science.”
Rapid Response by John Stone
PEG in the Pfizer vaccine: not a good start
Re: Vaccinating the UK against covid-19 Azeem Majeed, Mariam Molokhia. 371:doi 10.1136/bmj.m4654
The day after the roll out of the Pfizer vaccine commenced the MHRA were forced to issue a belated warning about the risk of anaphylaxis with particular suspicion surrounding the ingredient Polyetheline Glycol (PEG). MHRA Chief Executive June Raine said in a statement:
“Any person with a history of anaphylaxis to a vaccine, medicine or food should not receive the Pfizer BioNTech vaccine”
It was indicated that the issue may not come to light because people susceptible to allergic reactions had been excluded from Pfizer’s trials in the first place .
It is troubling this issue should have been revealed only after the product was offered to the public since it is apparent from the Reuter’s report that it was a known risk. In particular, I would point out that Children’s Health Defense, an organisation with which I am associated, including its chairman Robert F Kennedy Jr, wrote to the US government alerting it to the issue of PEG in relation to the rival Moderna product in August [2,3].
 Alistair Smout, ‘ UK issues anaphylaxis warning on Pfizer vaccine after adverse reactions’, Reuters 9 December 2020, https://uk.reuters.com/article/health-coronavirus-britain-vaccine/vaccin…
 Lyn Redwood, ‘ Breaking: CHD Responds to News of Life-Threatening Reaction to Pfizer COVID Vaccine. Will Regulators Take Action?’, Children’s Health Defense 9 December 2020, https://childrenshealthdefense.org/defender/pfizer-covid-vaccine-allergi…
 Robert F Kennedy Jr, Lyn Redwood, Harold Gielow, Letter to Dr Jerry Menikoff (Director, Office for Human Research Protections, Department of Health and Human Services), 26 August 2020, https://childrenshealthdefense.org/wp-content/uploads/Letter-to-OHRP-8-2…
Competing interests: AgeofAutism.com, an on-line daily journal, concerns itself with the potential environmental sources for the proliferation of autism, neurological impairment, immune dysfunction and chronic disease. I receive no payment as UK Editor. I also moderate comments for the on-line journal ‘The Defender’ for which I am paid. I am also a member of the UK Medical Freedom Alliance
¿Qué dice la ciencia respecto a las
Now as countries prepare to vaccinate millions of citizens with #coronavirus #vaccines that have been developed faster than any other in history, what does the evidence tell us so far?
¿Qué dice la ciencia respecto a las #vacunas #covid19?
9:23 am · 12 Dec 2020
The Institute of Scientific Freedom
Elation or caution over COVID-19 vaccines? The evidence so far.
Published on December 11, 2020
Maryanne Demasi reflects on the reports published this week about two corona vaccines.
The new vaccines have offered some hope that, sometime down the road, our lives can return to normal.
Science by press release
Much of what we initially learned about coronavirus vaccine safety and efficacy data came from drug company press releases.
In response to the frenzied media coverage, Dr Richard Horton, editor-in-chief of The Lancet commented on Twitter; “Publishing interim results through a press release is neither good scientific practice nor does it help to build public trust in vaccines. An announcement should come with full publication of a peer-reviewed research paper in a scientific journal.”
Fiona Godlee, editor-in-chief of the BMJ also commented; “Science by press release is just one of many flaws in the way new treatments are evaluated,” she wrote, pointing to previous fiascos involving anti-viral drugs such as remdesivir and Tamiflu.
What about harms?
A week after the UK became the first western country to grant EUA for Pfizer’s vaccine, the US FDA released a 53-page public report, showing the vaccine has high efficacy (~90%), noting that six deaths had occurred during the trials, although, they say none were linked to the vaccine.
Oxford/AstraZeneca vaccine hits a snag
Of note, not included in these three trials, is the trial underway in India with the Oxford/AstraZeneca vaccine, known as “Covishield”. A participant developed acute neuroencephalopathy ten days after receiving a single shot of vaccine (not the placebo), and later sought compensation for his injuries.
The company manufacturing the vaccine (Serum Institute of India, SII) said the claim was “malicious and misconceived,” and has threatened to sue the trial participant for damages. The company has powered on, just announcing that it has applied for emergency use approval of the Covishield vaccine.
Patrick D Hahn
#Eli_Lilly re-coded suicide attempts in #Prozac trials as “#depression,” “#overdose,” or “no drug effect.”
Patrick D Hahn
#Eli_LIlly hid information about suicide attempts in #Prozac trials.
Will those who are giving the vaccines be informed of individual’s medications? Who will be responsible for that?
Will they be taking note ? Lets hope so. At present there are ‘about half’ (re ITV news) of care workers who don’t trust taking it for themselves . They gave no pokk results for Drs. Those they care for are not being given the information the care workers have – and the carers won’t be allowed to inform them of concerns.
Published in Rxisk earlier this year. I’ve had to delete the the parts which need translation but google translation can be used on the blog itself.
Covid and the Market in Research
Print Friendly, PDF & Email
April 13, 2020 | 20 Comments
There are 3 bits to this post – an interview with Joan-Ramon Laporte. An article by Ariane Denoyel and a Q and A with Laporte and Healy.
As part of a series for ROAR Magazine, Frank Barat has run some striking interviews about aspects of the Covid pandemic not usually mentioned.
Here is Joan-Ramon Laporte talking about the market in research for drugs or vaccines that we have in lieu of the solidarity needed to do the job in a trustworthy way.
The full interview is Here. Some of the key points Joan-Ramon made are:
At the end of Jan the WHO recommended trials of already known drugs with known effects such as adverse effects, dosage, contra- indications.
Hydroxychloroquine has been researched in 50 separate trials and 400 studies although there is no evidence it works as a successful treatment for people humans. ( recorded on a link to Covid on the Register for Clinical Trials.gov.)
The ‘Marseille’ clinical trial claiming hydroxychloroquine works is at odds with trials carried out in China.
The Marseille trial is seriously flawed. It does not conform to a genuine clinical trial. A series of patients 50 people in good health with good prognosis were given Hydroxychloroquine and it was stated there were zer0 deaths and all discharged. In fact 1 or 2 did die but were excluded from analysis. There was no comparative group included in the trial. And the group behind the claim are not willing to publish the results.
By comparison a separate trial completed in China found there were no favourable results from taking Hydroxychloroquine.
Joan-Ramon describes the way pharma companies approach different research establishments with incentives in the way of offers of payment to carry out certain trials – the priority is decided by pharma with the payments on offer being according to type of research they want eg 500 Euros for one condition 2000 for another.
They set up a competitive market. It is not known how much is being paid for Covid trials. This is causing harm to the public health and older people in particular who are prescribed massive amounts of unnecessary medication. Patients like this may be excluded from trials claiming the vaccine works.
All these drugs prescribed for other conditions need to be investigated to see how much they influence the chance of catching Covid and responding to a vaccine.
The ‘sacred cows’ of clinical research should be replaced with a collaborative system for clinical research overseen by international authorities.
Meanwhile the public can best protect themselves by keeping things simple , Cutting out or reducing all the dangerous cocktails of prescribed drugs which will then reduce the chance of contracting Covid
The full interview is HERE
Ariane Denoyel wrote an article linked to last week’s post on medicines compromising our responses to Covid in L’Arriere Cour. The google translation is not too bad.
Laporte – Healy Thumbnail Interview
Would you take any of the following prophylactically to ward off the risk of Covid infection, manage stress or other risks
JRL No (unless new evidence turns up)
JRL Same as chloroquine
JRL No (unless new evidence turns up)
JRL Perhaps (well tolerated)
DH No – because of neurological side effects
Other Prophylactic Antibiotics
To manage other conditions
DH No – because of cognitive and muscular problems
JRL Depends on whether severe
DH Would minimise steroids but important to keep good control. Would avoid montelukast and other leukotriene antagonists
DH No – except for acute injury – a fracture perhaps. Would use clonidine to withdraw from these if I had been on them chronically
DH Never. Would try to minimise the dose if I had already been on them. This may be very difficult to do
DH In the case of drugs like biologicals for arthritis or inflammatory bowel disease, patients often have to pause when they get infections – so they know if they are likely to have a flare of their condition if they pause. If not likely to have a flare, I would consider pausing – otherwise no.
Gabapentin – Pregabalin
DH Tricky. Perhaps if sleepless because of an acute shock, as sleep is likely important. Would not take routinely. Withdrawal makes stopping difficult
Proton Pump Inhibitors
DH No. If already on them, stopping can cause reflux and anxiety and needs to be done slowly using a sodium alginate-bicarbonate mix (Gaviscon).
DH Would not start one now. Would reduce the number of antihypertensives if already on one, and particularly would stop a beta-blocker. A modest elevation of blood pressure is not a problem.
DH This is a time to be on less than 5 medicines. A time when less will offer greater efficacy than more
If you contract Covid, would you take any of the following if initially ill
DH No. Covid is heat sensitive – it might be a better bet to get a dose of malaria than take this anti-malarial drug (chloroquine).
DH No. See chloroquine response.
JRL Would depend on ECG – more acceptable than chloroquine and hydroxychloroquine
JRL I suppose yes
DH Will monitor the evidence – possible if only for a few days
JRL No – would take paracetamol
DH Yes – low dose – I am more NSAID than paracetamol responsive
Steroids – Immunosuppressants
JRL Depends on the condition
DH Would pause if possible
Annie – – thanks for link
Taking a risk of accepting a vaccine for the common good – and paying for the potential harms which the MHRA has flagged up as potentially significant. The government’s record on assisting people who have been harmed by prescribing policies is disgraceful, they are more concerned to save money than protect citizens.
To encourage uptake of the COVID-19 vaccine, it is recommended that compensation
schemes should be in place in case of a rare but serious event resulting from the vaccines.
The UK government has granted Pfizer a legal indemnity protecting the drug company from
being sued by patients in the event of any complications. Instead, people are able to claim a
“Vaccine Damage Payment”, as stated on its website:
“If you’re severely disabled as a result of a vaccination against certain diseases, you could
get a one-off tax-free payment of £120,000.” It goes on to explain that the payment could
affect entitlements to other benefits such as income support, housing benefits and
employment / support allowance.
The UK’s Independent newspaper reported that Pfizer’s UK managing director refused to
explain why the company needed an indemnity, saying, “We’re not actually disclosing any of
the details around any of the aspects of that agreement and specifically around the liability
In the US, there is already a law, the National Childhood Vaccine Injury Act of 1986, which
was created as a no-fault compensation program. The purpose of the Act was to eliminate
the potential financial liability of vaccine manufacturers in the event of vaccine injury claims.
The Australian government has committed to indemnifying two COVID-19 vaccine
manufacturers (AstraZeneca and Commonwealth Serum Laboratories) against any potential
lawsuits, but is mostly silent on the details, except to say, that it will cover the cost of
Severe disablement in UK means 60% If this claim is carried out by agencies such as dealing with disability benefits presently they will make life even more of a nightmare. Especially as weasel wording is used eg ‘could’ get a payment, The guidance people are referred to on the gov. site as to how to make a claim for vaccine damage makes no reference specifically to Covid
This meanspirited shabby scheme designed to protect pharma and governments would make it not worth risking losing benefits for some people .
It should be made transparent within the consent process when (and if as it’s doubtful if that will always take place ) a discussion of severe harms is honestly made. The media never mentions them , they downplay potential adverse effects.
re above – So here it is – Consent will just be a thumbprint on a scrap of paper soon. Or let’s have a tick on the pinnacle system , which on its own will give even less proof of consent More haste less speed is aready causing publicly stated concern and mistrust , This is yet another thing to add to it.
In Pulse Today (free to view)
11 December 2020
GP teams delivering Covid vaccinations should visit care homes a ‘minimum’ of four times, NHS England has said.
New guidance also clarified that written consent is not required for each patient.
It comes as the patient group direction under which GPs will deliver Covid vaccinations has today been published – ahead of rollout next week.
In new standard operating procedures for practices signed up to deliver the programme, NHS England said that a ‘minimum four visit schedule is recommended’ to vaccinate care home residents and staff.
This is ‘subject to the vaccine being approved for deployment in care homes’, it added.
The guidance said: ‘As a principle, providers should seek to minimise the number of unnecessary visits to care homes to mitigate potential risk to residents. A minimum four visit schedule is recommended.’
The first would be to deliver the first dose to ‘all or most’ residents and staff on site, with a second one week later to vaccinate those unavailable on the first day, it added.
The third visit would be to deliver a second dose to the first cohort, scheduled according to the time period specified by the vaccine manufacturer, and the final visit would ‘capture outstanding doses one week later’.
The guidance added: ‘A regular follow up visit until mass population coverage has been achieved may be required, PCN’s should agree an ongoing rolling process with care homes.’
PCNs should consider a mobile or ‘roving’ vaccination team to deliver the service to care homes as well as ‘what assistance other providers such as community/district nursing teams could’ provide to vaccinate the cohort, it said.
However, providers are ‘responsible’ for ensuring any staff are ‘appropriately trained and the appropriate documentation is place for indemnity purposes’, such as honorary contracts or staff sharing arrangements, it added.
And PCNs and roving vaccination teams should ‘consider’ Covid testing before visiting care homes to ‘mitigate the risk of vaccinators testing positive on arrival’, NHS England said.
It added: ‘[This] could have implications for the whole vaccination team leading to disruption of the planned session and potential vaccine waste’.
The guidance also said that for care home vaccinations:
PCN clinical leads should be ‘available for advice’ but the registered GP practice ‘would normally be the first contact for advice around adverse reaction’
PCNs should ‘encourage’ care homes to ‘maximise’ staff and resident flu jabs ahead of Covid vaccination to ensure seven days between flu and Covid jabs
PCNs should encourage care homes to begin ‘informal conversations’ regarding consent, including with relatives, ahead of formal consent when vaccine type is confirmed
Care homes should seek informed consent four to five days before the vaccination team attend.
Meanwhile, the document also confirmed that there is no need for written consent from patients in any setting.
It said: ‘Chapter 2 of the Green Book states consent must be obtained before administration of all vaccines. The guidance in this chapter is based both on the current legal position and the standards expected of health professionals by their regulatory bodies.
‘There is no legal requirement for consent to immunisation to be in writing and a signature on a consent form is not conclusive proof that consent has been given, but serves to record the decision and the discussions that have taken place with the patient or the person giving consent on a child’s behalf.’
However, it added that informed consent should be recorded on the online Pinnacle system and the patient should be provided with written information about the vaccine.
GPs were last weekend given the green light to start delivering Covid vaccinations in the week commencing 14 December.
However, NHS England last week said that the rollout of the Pfizer vaccine would not begin in care homes, despite residents and staff being the JCVI’s first priority group.
It followed the Welsh Government announcing that they are not yet able to vaccinate care homes, while care home residents in Scotland will be vaccinated against Covid from 14 December.
Peter Roderick: Transparency in approving covid-19 vaccines
December 17, 2020
Transparency is generally regarded as essential for public trust in medicines, and likely to lead to better decision-making. Yet lack of transparency has been a hallmark of the regulation of medicines. Modest improvements have been made over the last decade, but the spotlight is being shone again on how the regulatory system operates as approvals are being given or considered for several covid-19 vaccines.
In the US, the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) held live-streamed public meetings to discuss the issue generally on 22 October 2020, and specifically for the Pfizer/BioNTech vaccine, with an FDA analysis, on 10 December ahead of the FDA’s decision. That meeting voted 17/4, and one abstention, in favour of emergency use approval, which was issued the next day. A further meeting is scheduled pre-licensure for the Moderna vaccine on 17 December. As the FDA head, Stephen M. Hahn has said, “The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines”.
Comparing this with the UK is like comparing chalk with cheese. Vaccine approvals in the UK are given on behalf of ministers. The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care. It performs the Secretary of State’s duties in licensing medicines under a framework agreement with the Department, but has no separate legal status. A temporary authorisation for the Pfizer/BioNTech vaccine was announced on 2 December. Three documents, including authorisation conditions, were posted on the MHRA webpages, but these do not include any analysis, evidence submitted by the companies such as clinical study reports, or the pharmacovigilance plan. MHRA’s public assessment report was published on 15 December.
Approval was given “with advice from the Commission on Human Medicines.” The Commission has a statutory duty to advise ministers on the safety, efficacy and quality of medicines. No public meetings were held by the Commission or its expert sub-groups. The Commission’s advice to ministers has not been published. The sub-groups’ advice to the Commission has not been published. Scant “summary” minutes of private meetings of the Commission and expert advisory groups have been published. Commission minutes are usually prefaced with a statement that “Information is being withheld, under Section 43 of the Freedom of Information Act 2000, on the grounds that information regarding the issue under consideration and advice from the CHM remains confidential at the date of this summary and will remain so until a final decision has been taken. There is no overriding public interest to release such information in advance of the regulatory process being completed (sic).”
But no Commission minutes have been published for any of its meetings since 30 July 2020. Under the heading “Update from the Covid-19 Expert Working Group”, the summary minute of that meeting merely states that “The Commission agreed with the conclusion of the EWG minutes.” According to the Commission’s website, there is no such body as the Covid-19 Expert Working Group, but there’s a COVID-19 Therapeutics Expert Working Group, a COVID-19 Vaccines Safety Surveillance Methodologies Expert Working Group and a COVID-19 Vaccines Benefit Risk Expert Working Group. No minutes of meetings are published for any of these working groups. We now know from the MHRA assessment report that the Benefit Risk EWG gave advice to the Commission on five occasions between 11 September and 30 November 2020.
Moreover, declarations of interests of the members of the Commission and its sub-groups have not been updated since 2018. No declarations of interest have been published for the three covid-19 working groups.
The secrecy around SAGE in the spring should not now be repeated for vaccines. Kindly show, not just tell. The advice of the Commission and its sub-groups on covid-19 vaccines must be published, along with the evidence submitted by the companies and the pharmacovigilance plan, and, in time, safety reports. Clinical study reports, usually redacted, are made available generally by the European Medicines Agency, both reactively and proactively. The MHRA’s practice post-Brexit is unknown. The Freedom of Information Act will apply, but proactive publication of the reports by the MHRA is necessary now. Fuller and timely publication of meeting minutes that provide meaningful information, and of declarations of interest, is also necessary. More widely, the Medicines and Medical Devices Bill currently going through Parliament is an obvious opportunity to establish the MHRA as a statutory regulator free from direct ministerial control and to set out transparency and public dialogue obligations. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases in the US, apologised for his comment that the UK “did not do [vaccine approval] as carefully” as the FDA: perhaps he was being polite.
Peter Roderick is a Principal Research Associate in the Population Health Sciences Institute at Newcastle University, UK
Competing interests: None declared
None of our business
The EMA covid-19 data leak, and what it tells us about mRNA instability
BMJ 2021; 372 doi: https://doi.org/10.1136/bmj.n627 (Published 10 March 2021)
Cite this as: BMJ 2021;372:n627