This is the third case in the Cause and Effect Forum that looks at how we establish if a vaccine or a drug has caused a harm.
On January 7, 2022, there was an extraordinary article in the BMJ by Priyanka Pulla – How Covid-19 vaccines exposed India’s adverse event reporting systems. This outlined a series of injuries and deaths on Covid vaccines in India but was focused primarily on the Adverse Event Following Immunisation (AEFI) reporting system which had effectively just been put in place a short while before and was not yet up to speed. As a result, families were commonly left unclear on whether the vaccine had caused the death of a loved one or what might have happened.
The article maybe leans towards painting the situation as worse in India than elsewhere but my reaction was that things are not really different anywhere else. Nobody who reports to whatever System their country has ever gets a clear answer – other than maybe the vaccines don’t cause problems and yes you should have your next dose.
Some of the cases outlined were compelling. For me the story of Venugopalan Govindan and his daughter Karunya stood out, so much so that I contacted Priyanka to get Venu’s address and then contacted him to find out more. In the article and in real life, it seemed clear that while he was less concerned about the AEFI system he was even more concerned about the vaccine propaganda that had led his daughter to rush into getting treated and left her family and the medical system unaware of what might be happening when things started to go wrong and as a result slow to intervene in ways that might have saved her.
Venu and his wife Sujini and I met by Zoom on January 10. He sent me Karunya’s medical records before we met and his summary of what happened.
For me the interview brought home our common humanity. Venu and his family and their story about Karunya could have been the story of the family next door. Their sorrow and now anger made me feel I had more in common with them than with most of the people I meet these days even though neither I nor the people I meet here have lost anyone to Covid, or anyone close to me to a vaccine.
Karunya was the eldest of 2 children, 20 years old, fit and healthy. The family had annual check-ups as part of their health insurance and she was always the healthiest of them.
Against a background of media coverage that everyone must get vaccinated, her parents, grandparents and other family before her had the Astra-Zeneca Covishield vaccine without harm. Vaccination was opened up to people 18 and up from May and she had the injection on June 8. She had a slight fever that night but went to work the next day.
A week later she developed a fever and a sore throat, so sore she couldn’t eat or drink or talk. Everyone thought she had Covid but a PCR was negative. A local doctor gave her treatment for a sore throat but this was no use and a day later she was admitted to hospital, where her inflammatory markers – C-Reactive Protein (CRP), ESR and d-Dimer results were very high, along with immune markers like white cell counts.
After 4 days without improvement she was transferred to a teaching hospital, where because of her immune markers it was assumed she had an infection and so antibiotics were the mainstay of treatment.
Anticoagulants and steroids were only introduced on July 4 and IVIg on July 7 but these has little impact at this point. She was transferred to ICU. At every stage of this, her family were confident that the next step in treatment was going to make a difference and restore her to normal.
Karunya died on July 10 to her parents bewilderment. They could not believe she would not be coming home.
The diagnosis on her medical record was Multi-System Inflammatory Syndrome (MIS). This can be caused by Covid but repeated tests were negative. The push to get children vaccinated is because of this syndrome – called MIS-C (C for children). Covid is pretty harmless for children but we are told MIS-C can happen and can be lethal. MIS-C is real but vanishingly rare.
MIS leads to pleural and pericardial effusions among other things, all of which Karunya had.
There have now been several cases of MIS-V published, where clinical pictures like this develop against a background of Covid negative tests. This is the kind of case that early steroids, like dexamethasone, can help with. With an early diagnosis she likely didn’t have to die.
While at every step of the way they expected their daughter to recover, after she entered hospital with a negative Covid test, Karunya’s parents began to think the vaccine was causing the problem. Every time they raised this possibility, they were told no – this was not possible.
It was only after her death that the first entry in her medical record raised the possibility that the vaccine might have caused her suffering and death. The family had sensed by this point that the medical team did not have any protocols for treating someone who was having a vaccine induced problem.
Venu contacted the Serum Institute of India, where the vaccine was made, thinking they might have treatment protocols but it seemed a completely new idea to the bureaucrats there, even the doctors, that they might have any role in managing problems like this. [Our vaccines are used in 170 countries around the world, saving millions of lives].
Venu filed an Adverse Event Following Immunization (AEFI) report with the system in India. They did not deny that the Vaccine had caused the event but claimed to be unable to decide for certain whether it had done so or not.
Venu and I engaged in correspondence with a vaccine defender who wishes to remain nameless and does not want his emails published here but you can infer his points from my responses.
In medicine and all science we make judgement calls based on a balance of medical probabilities – just as we do in legal cases. Absolute certainty – beyond all reasonable doubt – is reserved for cases where the outcome is the death penalty.
A balance of probabilities is normal scientific causality. Sure we may be wrong and need to take other evidence into account – which in legal and clinical cases and in science we do all the time so that if fresh evidence comes up we reserve the right to change our mind.
In Karunya’s case, the only reasonable explanation on the face of it, given the sequence of events is the vaccine killed her.
This doesn’t mean there can’t be contributory factors like a prior Covid infection, but even with that she would not have died had she not had the vaccine.
I accept that there are things people should be screened for prior to vaccination should as anti-nucleocapsid antibodies and antibodies that make thrombosis more likely and alpha1-antitripsin deficiencies, but do you really think the authorities are going to advise people to get screened for any of these?
Given the details we have, is it not more likely Karunya died from the vaccine we know she had rather than from an asymptomatic Covid infection she just happened to have at that time and was test-negative for. I’m not ruling out the latter possibility but it strains credibility to think this rather than the vaccine was the cause.
A Covid infection likely produces the same antibodies through its spike protein which the vaccines also produces. It seems increasingly like that across a range of rarely tested antibodies that we have both the infection and the vaccine producing the same antibodies and the same harms.
Another factor is this. The argument you offer can be translated into SSRI antidepressant terms and is used by the defenders of the drugs. These drugs can cause people to commit suicide. One of the many arguments the defenders of the drugs use is that this is because the people who do so were bipolar and were put on the wrong treatment. Face them with the fact that healthy volunteers with no prior mental health history become suicidal and commit suicide on these drugs – they respond that even these people were likely bipolar.
The most solid causal evidence you can find – that increasing the dose of SSRI makes things worse and reducing the dose or stopping clears the problem up and reintroducing treatment brings the problem back and an antidote can ease the problem – does not persuade the defenders.
The SSRI and vaccine defenders trade on a model of absolute causality. You can adopt this if you want but it is not how things work clinically. If I’m treating you with an SSRI and you become suicidal, and perhaps tell me you’ve been suicidal before but this was different, you and I between us (or you or on your own if I’m not listening) need to make a judgement call – reduce the dose and even stop the treatment – or increase the dose on the basis that it is the illness causing the problem. Your life depends on calls like which are made on the balance of medical probabilities.
Re WHO manual and its algorithms – no I don’t agree with you.
I run a website called RxISK.org and on that we use a modified Naranjo algorithm. This is based on a line of thinking that goes back to Robert Koch’s proposal for deciding does the cholera bacillus cause cholera. We accept Koch’s idea that this is broadly how we prove cause and effect (for a germ or drug) even though Max von Pettenkoffer immediately afterwards brewed up a glass of cholera bacilli and drank it and was unharmed
I’m not against algorithms but they essentially remind people of questions to ask and give a score that can steer us toward one line of thinking – sometimes incorrectly. They are like rating scales. New phenomena that turn up don’t do well on algorithms.
In the case of some of these thrombotic phenomena, let me tell you what happened. Neurologists in 2020 were seeing an increase in Carotid Sinus Thromboses, with Covid. They were seeing several in a hospital where in a typical year they might see one. Nobody ever said – no Covid doesn’t cause this. Nobody rushed out to say don’t be alarmed at these misguided stories about Carotid Sinus Thromboses – they haven’t been through an algorithm.
It was totally predictable that when a vaccine that reproduces the Spike Protein began to be used that similar phenomena would be observed and that a bunch of doctors primed by the increased number of these events in the previous year would make a link to the vaccine. There would have been no reports to regulators of this problem unless that was the case and most of the doctors reporting will have only reported because of their certainty the vaccine was causing the problem.
None of these doctors will have gone anywhere near the WHO document – which is a document for bureaucrats not doctors or patients.
Bureaucrats like FDA, CDC, MHRA, EMA etc want paper trails and documents and to be able to say they are adherent to process. They never discover anything. Rarely and reluctantly when the data has become too overwhelming to disagree they might concede a link.
I come back to antidepressants. An antidepressant like imipramine that causes suicide can reduce suicide rates overall by treating severe depressions (in a way that SSRIs don’t). But we should not say these drugs can’t cause suicide because overall suicide rates fall when in individuals the drug can incontrovertibly cause suicide.
When the SSRIs overall in trials had excess suicides and suicidal acts compared to placebo – as the vaccines have excess deaths in RCTs compared to placebo, the drug companies turned to real world data saying suicide rates have fallen since SSRIs were introduced. Suicide rates were falling before SSRIs were introduced but this is better linked to falling autopsy rates than to anything else.
Quite astonishingly, there has been a strong disincentive to have autopsies in people who have had vaccines.
Re not having a biological basis for the vaccine harms – we still don’t have one for thalidomide and the birth defects it causes. Are you saying these aren’t incontrovertible?
Having biological fig leaves can be nice but you need more than a fig leave to be properly covered.
Shortly after this email exchange, the inimitable Bob Fiddaman pursuing a correspondence with the British Regulator – the Medicines and Health Products Regulatory Agency (MHRA – aka CDC, EMA etc) was stopped in his tracks by one of their replies.
MHRA, as usual, were refusing to commit to the idea that there had ever been an adverse event on anything – drug or vaccine – or to specify exactly they go about deciding if there might have been an adverse event. Then all of sudden there was a bit of straight talking from the bureaucrats:
Should a reporter of a Yellow Card, upon reflection or receipt of additional information, no longer suspect that the drug or vaccine was the cause of the adverse reaction(s) reported the MHRA accepts this information.
Just to make this absolutely clear. MHRA are saying they pay no heed to a doctor who says a drug or vaccine caused a problem but they totally agree with a doctor who decides the drug or vaccine did not cause the problem.
On February 24, a Telanga Court issued an instruction to The Wire to take down 14 articles about Bharat Biotech and its Covaxin vaccine.
The Court order was directed at The Wire but also 12 others including Priyanka Pulla. Covering vaccines is a dangerous business wherever in the world you are.
The Wire has said they will defend their position.
Also in India Amar Jesani and the Indian Journal of Medical Ethics have been shining a sophisticated light on all medical ethics issues including what has been happening with vaccines, harms and mandates. For many, the Indian Journal of Medical Ethics has emerged as one of the leading bioethical journals in the world in recent years – in part because of its independent take on serious problems.
In the last two decades, Jacob Puliyel, an Indian paediatrician, has done as much if not more than anyone else in the world to raise awareness of vaccine hazards. Jacob drew my attention to two key Cause and Effect articles which tackle the use of algorithms to solve cause and effect problems – See Bellavita and Pulliyel.
It is very clear that the WHO algorithm for vaccine related injuries, mentioned above, stresses that you need to go out of your way to find some explanation other than the vaccine in the case of injuries that happen after being vaccinated. Three years ago of course, just before Covid, WHO defined vaccine hesitancy as one of the Ten Greatest Threats to Global Health.
Back in 2008 a new virus was described – a Clinical Immune Deficiency Virus (CIV). This virus affects the immune systems of doctors and the media most, making them a threat rather than a support to us. These are the people who consume the idea that the Clinical Trials that bring drugs on the market are Science and we must follow this science even when there is:
It is no surprise that we have had Falling Life Expectancies from the pandemic this has led to which manifested in falling life expectanices 5 years before Covid appeared.