by George Santayana
The Declaration of Geneva of the World Medical Association binds the physician with the words, “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act in the patient’s best interest when providing medical care.”From the General Principles in the Declaration of Helsinki.
Let me start with a couple of confessions.
My first confession is that I work in the pharmaceutical industry and have done so for far more years than I’d like to admit (a Big Pharma Shill as one BTL commentator so kindly put it!). My second confession is that I’m a big fan of vaccination. I believe that clean water, vaccinations, and antibiotics are the three greatest medical innovations and together have probably saved more lives than all other medicines put together. But that said, I’m a supporter of vaccinations in the same way that I’m a proponent of any medical treatment… when it is the right treatment for the right person at the right time.
So, with those confessions off my chest, you can see that when I say that I believe that the proposed vaccination of healthy 12-15 year-olds against COVID-19 is morally, clinically and ethically wrong I am doing so from the perspective of a boringly mainstream industrial scientist and someone firmly on the inside of the large pharma Evil Empire.
Like many things in life, medical treatments come with some level of risk to the person receiving them and these risks need to be balanced against the benefit to this person. The balance of benefit and risk for a treatment can be a very individual affair and it is one of the skills of the doctor to make this judgement for their patient. In my world, understanding the balance of benefit/risk for new medicines is one of the main aims of drug development and the aim of good quality clinical trials is to try and fairly demonstrate that the benefits of a new treatment outweigh the risks to the patients who will be receiving it.
Benefit/risk can be quite nuanced, but in the case of vaccinating 12-15 year-olds against SARS-CoV-2, it is very clear. You can read the JCVI’s statement on COVID-19 yourself and form your own judgement based on the figures which are presented in the report, which I have reproduced below.
First, the benefits. There are approximately 3,200,000 12-15 year-olds in the U.K. and so we can convert the figures from the tables which are presented as X/million in the JCVI report into a number of cases based on this population. From Table One, one vaccination dose is predicted to prevent seven children ending up in the paediatric ICU, 278 hospitalisations and 49 cases of paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 infection (PIMS-TS). You can straight away see from Table Two that there is almost no additional benefit to a second dose which means that after two doses (Table Three), we only prevent eight kids ending up in the paediatric ICU, 296 hospitalisations and 88 cases of PIMS-TS.
It is unclear if these benefits are accumulative or over-lapping, i.e., are the ICU patients in addition to non-ICU hospitalisations and are the PIMS-TS patients counted separately or do some end up in hospital? I suspect there is some double-counting here. Also, the long-term outcomes of the hospitalisations and PIMS-TS cases are not discussed and so we don’t really know how many of the prevented outcomes would result in long-term problems for the children involved if they weren’t prevented. Clearly, the ICU cases are serious, but what about the other hospitalisations? Do these range from day-cases to long-term, more serious stays? The “T” in PIMS-TS is “temporally” so does this suggest that this syndrome resolves and, as unpleasant as it might be, is not life-threatening? Also, the word “syndrome” means that it encompasses a huge range of symptoms and so, one assumes, comes in a range of severities. Overall, these benefits are not well quantified in this summary document but taken at face value it does appear that there is some rationale to vaccinating 12-15 year-old children to avoid serious COVID-19 related illness.
But that’s just one side of the equation. What about the risks? Or more specifically, what about the risk, because the JCVI seems to have only really focused on the risk of myocarditis… but to be honest, they don’t really need to go much beyond this.
The risk of developing vaccine-induced myocarditis (inflammation of the heart muscle) (Table Four) ranges from approximately one in 330,000 to one in 60,000 following one dose rising to one in 83,000 to one in 30,000 after two doses. So, again assuming there are about 3.2 million 12-15 year-olds in the U.K. and we vaccinated all of them, we could expect between 9-54 cases of vaccine-induced myocarditis following one dose and between 38-108 cases if we double vaccinated. Serious enough in itself but compound by the fact, as highlighted by the JCVI, that we don’t know what, if any, the long-term consequences are for the children who develop myocarditis after vaccination.
No wonder the JCVI wasn’t supportive. To say that the benefit/risk is marginally positive is to be generous. Even for one vaccine dose the lower estimates of vaccine-induced myocarditis exceed the predicted reduction in the number of severe hospitalisations (CPU cases) and generating potentially long-term cardiac issues in healthy children to avoid a small number of serious COVID-19 cases in this cohort seems to go against the principle of “first do no harm”. For two doses it’s much worse because we gain almost no additional benefit but more than double the risk of adverse cardiac events. And this is only considering this one adverse event and ignoring all the other potentially serious safety problems.
Under normal circumstances, there is no way this would be approved as a treatment for this group. Yet here we are with the U.K. Government about to embark on the vaccination of 12-15 year-olds.
Something that is often glossed over as some kind of “detail” by those strongly advocating immunising as many people as possible against SARS-CoV-2 is that these are not approved medicines but are being used under emergency legislation. This means they are experimental treatments, not because they have never been trialled but because they haven’t completed the normal suite of clinical studies that are required for a vaccine to be authorised for use as a medicine in normal clinical practice. For their use in children, we also need to remember that youngsters are not just small adults but have their own unique physiology and so we can’t assume that adult results are relevant. Paediatric drug development is not a simple case of scaling down the adult dose but requires a whole host of dedicated studies and specific assessments. Which means that for the paediatric use of these vaccines the prior clinical data on their safety and efficacy is extremely limited despite millions of adults receiving the vaccine.
The bottom line is that, until approved, these vaccinations will remain experimental treatments, and far from this being a “detail” it means that ethically and clinically we should treat them as medicines in development and not as established drugs.
Experimental treatments are developed within the framework of good clinical practice or GCP. Within the U.K. and Europe, GCP is described in the nattily titled document “ICH E6 (R2) Good Clinical Practice”. This document defines the roles and responsibilities needed to develop a new medicine and is not just a guide to best practice but sets out some of the legal frameworks that anyone developing drugs here must adhere to. I’m not intending to describe ICH E6 (R2) in any detail but have provided a link for those interested in learning more about what goes into a clinical trial… or perhaps suffering from insomnia. What I want to highlight is that GCP is underpinned by some core ethical principles, explicitly those described in the Declaration of Helsinki which itself is founded upon the principles in the Nuremberg Code.
So, when we consider the use of the current COVID-19 vaccinations, it is the principles of GCP that I believe should be guiding us. Principles that the vaccination of children against SARS-CoV-2 ignore.
The Nuremberg Code was developed by the war crimes tribunal after the Second World War and put down 10 standards to which physicians must conform when experimenting on human subjects. It is this code that articulates the core requirement of voluntary informed consent. Informed consent isn’t some nice-to-have, but a fundamental human right that enshrines the rights of an individual to control what happens to their own body. It is also a right that has been undermined through the use of rewards and coercion in order to achieve a perceived societal benefit from COVID-19 vaccination. In fact, as I have discussed in a previous article, the destruction of informed consent is the logical consequence of assuming that society has some rights to decide which medical procedures are in the best interest of the population and once we do decide that this is ok, we start down a rocky road to a very unpleasant destination.
The Declaration of Helsinki was adopted by the World Medical Association in 1964 and builds on the Nuremberg Code to develop a set of ethical principles for medical research involving human subjects. I’ve started this article with the first of the General Principles in the Declaration which essentially asserts that it is the heath and best interests of the patient that must be the paramount consideration for a physician. Just like the Nuremberg Code, the Declaration of Helsinki focuses on the individual patient’s rights and how, regardless of the broader aims and benefits of the medical research, it is unethical to do this research if the individual’s rights are broken. And, like the Nuremberg Code, the rights described in the Declaration of Helsinki are just as open to erosion and destruction as soon as we start to consider potential societal needs over and above those of the individual.
In the Declaration of Helsinki, there is a section dealing with “Vulnerable Groups and Individuals” into which 12-15 year-old children would clearly fall. This states:
Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research.
It is explicit from this principle that the vulnerable group must be the main beneficiaries of the treatment and so any justification of vaccinating children to help protect others outside of this group destroys this principle and so is unethical. As described above, in the JCVI’s assessment there are some potential benefits associated with COVID-19 vaccination to 12-15 year-olds, but are they a health need or a priority? The loss of a young life is a tragedy and so avoiding this loss, if possible, would seem sensible but we cannot forget the risks of the treatment in our drive to achieve this benefit. A point that the Declaration of Helsinki makes clear in its section on “Risks, Burdens and Benefits”:
Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed. (My emphasis.)
And this is the key reason why vaccinating healthy 12-15 year-olds is so emphatically wrong.
When it comes to the vaccine-induced safety risks, such as myocarditis, we do not have enough data to adequately assess what they mean for this vulnerable group and, as a result, we do not know how to satisfactorily manage them. This was the point the JCVI was making when raising concerns about the long-term risks. I must also emphasise again; children are not small adults and for 12-15 year-olds with hormones racing and puberty in full swing we cannot necessarily transfer any knowledge or assessment of risks from the adult population to this group. It may be that the risks are short-term, manageable, and acceptable and so the balance of benefit/risk is okay… but the fact is we simply do not know, and finding out by immunising 100,000s of children in uncontrolled circumstances is no way to discover the truth. One cannot ignore these risks just because “they are very rare”, especially when the significant benefits may also be “very rare”.
This is a clear case of where the precautionary principle should be applied and where we should assume the worse outcomes and manage the situation accordingly. Here, we’d assume there will be long-term issues associated with vaccine-induced myocarditis, put in place a routine monitoring plan for those who have already suffered this adverse event to ensure they remain healthy and detect any issues as soon as we can, and not vaccinate anyone else in this group until we understand what, if any, long-term issues there may be. It is ironic to me that the precautionary principle has been wielded by the Government and their advisors to justify a whole host of unproven interventions during the COVID-19 pandemic (think masks, think lockdown), but it appears that when it gets in the way of a desired policy implementation it is something that can just be forgotten. As Groucho Marx once said: “Those are my principles, and if you don’t like them… well, I have others.”
I can perhaps understand politicians not being au fait with the details of ICH E6 (R2), but they should be aware that with experimental treatments like the COVID-19 vaccinations, they are in effect the sponsors of a massive real-world clinical trial:
[The sponsor is] An individual, company, institution, or organisation which takes responsibility for the initiation, management, and/or financing of a clinical trial.(ICH E6 (R2), Section 1.54)
As sponsors, the Government and politicians are ultimately responsible and accountable for what happens to people taking this experimental treatment. Even trying to make 12-15 year-old children somehow legally competent to make the decision about being vaccinated does not abrogate them of their responsibilities. So I’d suggest that they familiarise themselves with the principles in the Declaration of Helsinki and the Nuremberg Code and read about GCP, because you never know but perhaps at some future point a competent authority could come knocking on the door.
The ignorance of politicians is one thing, but ignorance of these frameworks and their ethical principles cannot be an excuse used by senior clinicians who are recommending using partially tested treatment on youngsters. Inventing additional benefits not directly related to treatment, such as positive impacts on mental health, to try and justify the use of these vaccinations might help them sleep at night but doesn’t change anything. They are still, in my opinion, breaking ethical and professional principles… principles which they swore to uphold. Unfortunately, it wouldn’t be the first time that doctors have given a political decision a veneer of medical respectability. History will be the judge.
What can we do? Probably not a lot. If the Government and their senior advisors are going to ignore the clear recommendations of their own experts, then individuals outside of these circles have no chance. Perhaps, send your MP a copy of the JCVI’s assessment and point out that the precautionary principle means that vaccinating children where there is a clear, poorly understood safety finding is unethical and immoral, irrespective of how rare the finding might be. Send them the Declaration of Helsinki and point out that they are ultimately responsible for what happens in these vaccination campaigns and to reflect on which side of the ethical argument they want to be on. Probably a futile endeavour, but at least they might understand that they are no longer “following the science” and hiding behind the recommendations of a group of politically connected senior doctors and academics is not going to wash their hands of any issues that arise with this policy. Ultimately though, COVID-19 vaccination of our children will now go ahead and although some parents and children will refuse the jab, I suspect many more won’t and so the only thing really left to do is to pray that the Government and their advisors turn out to be right… right that vaccinating 12-15 year-olds is actually in their best interests and that any vaccine-induced adverse events are rare, transient and do not have any long-term consequences. The alternative is one I shudder to contemplate.
George Santayana is a pseudonym. The author is an executive at a pharmaceutical company.