‘No man can be forced to be healthful, whether he will or not. In a
free society, individuals must judge for themselves what information they
choose to heed and what they ignore.’ John Locke. ‘A letter concerning Toleration’
Here, I am going have another look at
vaccination, before scurrying away from the subject for a bit, and getting back
to the safe ground of cardiovascular disease. Much to the relief of some of the
regular readers of this blog, no doubt.
I have to say that I thought long and hard about blogging on vaccination.
It is the most brutal area for discussion that I have
ever seen, and a reputation shredder. If you even dare to hint that there may
just be the slightest issue with any vaccine, people come down upon you like a
ton of bricks.
I also know that by daring to write on this
subject, there will inevitably be people moving behind the scenes to have my
blog taken down. I cannot imagine WordPress management going to the wire to
protect my right to free speech. A little flick of a switch, and I will be gone
from the airwaves.
However, as we move towards a world where it seems that all Governments
around the world are going to pass laws mandating vaccination for everyone, and
people are fined, or lose their jobs, for speaking out, or refusing to be
vaccinated, then I feel that some attempt to discuss the area is essential.
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Because,
once something becomes mandatory, and any research into possible harms moves
strictly off limits, we really need to be absolutely one hundred per-cent
certain that there is no possibility that we may be doing harm. Or, that we are
reducing any potential harm to the lowest level possible.
Can vaccines do harm?
‘Prof Martin Gore, 67, one of
the UK’s leading cancer scientists, has died, the Royal Marsden NHS foundation
trust has said. His death was following a yellow fever vaccination.’ 1
A
tragedy for a brilliant medical researcher and his family. It was brought to my
attention by my wife, who knew him quite well.
However, even here, we can
see any criticism of vaccines being toned down and deflected. The words ‘caused by’ were carefully avoided. It was reported that
he died following a yellow fever vaccination – which could
mean he was vaccinated, then got hit by a bus. In fact, if you read a little
more deeply, it becomes inarguable that the yellow fever vaccine was the direct
cause of his death.
Yes,
such an event is rare, but such events do occur. People can die following
vaccinations, as a direct cause of that vaccination, although the information
can be very difficult to find. In Germany, the Paul-Erlich Institute [PEI] is
the organisation responsible for the reporting of vaccine security/safety.
‘Between 1978 and 1993
approximately 13,500 cases of undesired effects resulting from medications for
vaccinations was reported to the Paul Erlich Institute (PEI) which is the
institute which is responsible for vaccine security; the majority was reported
by the pharmaceutical industry. In 40% of cases the complications were severe,
10% pertained to fatalities on account of the effects.’ 2
Yes,
the numbers are relatively small – although by no means vanishingly small. In a
fifteen-year period that is 1,350 deaths. If the Germans are preventing tens of
thousands of deaths a year through vaccination, then a thousand severe
complications and a hundred deaths or so, per year, may be a price worth
paying? Discuss.
Primum non nocere
My
own view is that you should never compel people to undergo a medical procedure
that could result in severe damage – or death. But my philosophy is very much
on the radical libertarian end of the spectrum. Others feel that personal
liberties should be restricted for the overall good of society. A central
philosophical divide, I suppose.
One
of the other interesting facts from the Paul-Erlich Institute is that ‘severe
cases’ of vaccine damage, that occur, that must be reported, include:
- Encephalopathia: Encephalopathia is frequently overlooked as
it does not always entail severe symptoms. However, there can later be
developmental retardation. Encephalopathia can also trigger cri
encéphalique
- Seizures
- Epilepsy
- Autism
- Sleeping sickness 2
These
are not my words; these are the words of the PEI.
This
list obviously raises the issue of potential brain damage following
vaccination. Something that was seen with Pandemrix, used to protect against
Swine Flu (HIN1).
‘An increased risk of
narcolepsy was found following vaccination with Pandemrix, a monovalent 2009
HIN1 influenza vaccine that was used in several European countries during the
HIN1 influenza pandemic. Narcolepsy is a chronic neurological caused by the
brain’s inability to regulate the sleep-wake cycles normally. This risk was
initially found in Finland, and then some other European countries also
detected an association. Most recently, scientists at the United Kingdom’s
Health Protection Agency (HPA) have found evidence of an association between
Pandemrix and narcolepsy in children in England. The findings are consistent
with studies from Finland and other countries.’ 2
[A
finding not seen in any safety testing carried out prior to the launch of
Pandemrix]
Thus, not only can vaccines cause severe
reactions up to, and including, death. They can also lead to neurological
damage such as narcolepsy. Is this all specifically to do with the vaccine
itself, or the preservative it is carried in, or something else? Who knows?
Yet,
and yet, despite the apparently indisputable evidence that vaccines can, and
do, cause neurological damage we can find articles such as this below. Chosen
pretty much at random, but it sums up the current mainstream thinking.
The “urban myth” of the
association between neurological disorders and vaccinations
‘In modern society, a
potentially serious adverse event attributed to a vaccination is likely to be
snapped up by the media, particularly newspapers and television, as it appeals
to the emotions of the public. The widespread news of the alleged adverse
events of vaccination has helped to create the “urban myth” that vaccines cause
serious neurological disorders and has boosted antivaccination associations.
This speculation is linked to the fact that the true causes of many
neurological diseases are largely unknown. The relationship between
vaccinations and the onset of serious neuropsychiatric diseases is certainly
one of coincidence rather than causality. This claim results from
controlled studies that have excluded the association between vaccines and
severe neurological diseases, therefore it can be said, with little risk of
error, that the association between modern vaccinations and serious
neurological disorders is a true “urban myth”. 3
What is being stated here, very
forcefully indeed, is that there is no causal relationship between vaccination
and neurological damage. It is simply a myth. I find the two bodies of evidence
here impossible to reconcile.
Just
to give two examples, the Paul Erlich Institute records encephalopathia,
seizures, epilepsy, deaths and suchlike, following vaccination. The Pandemrix
vaccine, in turn, has been proven to cause narcolepsy. Even the manufacturers,
GSK, admitted that it did.
‘The 2009 H1N1 influenza
pandemic left a troubling legacy in Europe: More than 1300 people who received
a vaccine to prevent the flu developed narcolepsy, an incurable, debilitating
condition that causes overpowering daytime sleepiness, sometimes accompanied by
a sudden muscle weakness in response to strong emotions such as laughter or
anger. The manufacturer, GlaxoSmithKline (GSK), has acknowledged the
link, and some patients and their families have already been awarded
compensation. But how the vaccine might have triggered the condition has been
unclear.4’
This is… I am not sure what
it is. The evidence clearly says one thing, yet we are told we must believe
that this evidence is simply an ‘urban myth.’ I feel
as though I have been transported to Wonderland, or some scary totalitarian
state, where the truth cannot be spoken.
Even
when it comes to the most contentious area of all, vaccines and autism, it
appears to have been accepted – at least in one case in the US – that
vaccination lead to autism, with a girl called Hannah Polling.
‘Officials at the US Department
of Health and Human Services investigating Hannah’s medical history said that
vaccine had ‘significantly aggravated an underlying mitochondrial disorder,
which predisposed her to deficits in energy metabolism’, causing damage ‘with
features of autism spectrum disorder’. 2
The final part of the statement was very difficult to understand. ‘The officials said that the vaccine didn’t cause her autism, but
‘resulted’ in it.’ The vaccine resulted in her autism. Or, her
autism resulted in her vaccination?
I have tried that statement a few different
ways around, and I have no idea what that means. A lead to B, but A did not
cause B. Because B resulted in A…
“Then you should say what you
mean,” the March Hare went on.
“I do, “ Alice
hastily replied; “at least I mean what I say, that’s the same
thing, you know.”
“Not the same thing a bit!” said
the Hatter. “Why, you might just as well say that “I see what I eat” is the
same thing as “I eat what I see!” Alice in Wonderland.
However, the Polling case
does raise a further potentially important issue. Namely, that it seems
possible that some people have underlying ‘mitochondrial dysfunction,’
and that vaccination may aggravate this problem, with potentially serious
consequences.
Narcolepsy,
for example, is believed by some researchers to be a problem with energy
production in the mitochondria. Others feel that ME/CFS (myalgic
encephalomyelitis/chronic fatigue syndrome) could be the result of a
mitochondrial dysfunction triggered by various viral infections and, therefore,
possibly vaccination?
All of which means that the possibility
exists that vaccination could trigger, or exacerbate, significant mitochondrial
dysfunction in susceptible individuals. This may or may not be true, but it
must surely be an area for research?
To my
mind it would be extremely important to establish if mitochondrial dysfunction
represents a ‘risk’ for vaccination. We could then identify, using some
genetic/epigenetic test, those individuals who are more likely to be damaged by
vaccination. At which point we could look at ways to prevent the risk of damage
– however small that risk may – be in a susceptible population.
For
example, it could be possible to space out the vaccines, or only give separate
vaccinations to these individuals. Maybe we could avoid vaccinating against
relatively mild conditions e.g. chicken pox, or rubella (in boys) in these
individuals. To me, these things seem eminently sensible areas for study.
However, it seems that we are
trapped within a paradigm where it is impossible to suggest that any vaccine,
for any disease, may be associated with/cause any degree of harm. In such an
environment, objective scientific research becomes impossible. ‘As vaccine can harm no-one, we cannot try to find out who may be
harmed. Thank you, comrade.’
As
you can probably tell, I find this all very worrying and deeply, deeply,
disturbing. If science has any purpose it is to seek the truth – however much
that upsets the current status quo. When I see, what I believe to be important
and valid questioning being crushed, I find it almost physically painful.
If that questioning results in the finding
that vaccines truly do not cause any adverse effects, then that is fine. I
would be more than happy with that outcome, although it currently seems
inarguable that vaccines do cause adverse effects. However, as I see it, we
currently have a situation whereby:
- Pharmaceutical companies do their own
safety testing on vaccines (somewhat like Boeing did on the 737 Max 8).
The regulatory authorities have been, effectively, side-lined.
- Many safety studies have only lasted
days, with little or no research on any long-term effects. In fact, as far
as I can establish, there has been no long-term safety research [see under
Pandemrix]
- Some vaccines have been proven to
cause neurological damage
- The preservatives and adjuvants in
vaccines have not been studied for safety
- There has never been a randomised
controlled clinical study on the efficacy of any vaccine – beyond looking
for a raised level of antibodies
- Some/many people can suffer from the
diseases they have been vaccinated against – and this is not monitored in
any way.
Any of these things should be a very large
red flag.
Looking
specifically at efficacy, on that list, it is usually stated that vaccines are
rigorously tested for efficacy. Here is what the University of Oxford has to
say in its site ‘Vaccine Knowledge Project.’
‘Phase III trials gather
statistically significant data on the vaccine’s safety and efficacy (how well
it works). This means looking at whether the vaccine generates a level of
immunity that would prevent disease, and provides evidence that the vaccine can
actually reduce the number of cases.’ 5
However,
this does not actually test whether a vaccine really does reduce the number of
cases of a disease. As I wrote in the previous blog, even in population with a
98% vaccination rate against measles, a school population still suffered a
measles outbreak, and many of those previously vaccinated suffered from
measles.
Which means that the statement
from the Vaccine Knowledge Project…. and provides evidence that the
vaccine can actually reduce the number of cases’ needs to be
read very carefully. It could be taken to mean ‘provides all the evidence
needed.’ Which is what it has been crafted to imply. However, it
actually means ‘provides evidence regarding a ‘surrogate
end-point’ which suggests that vaccines may reduce the number of cases.’
If
you want to know if a vaccine really works, vaccinate a hundred thousand people
against a disease. Do not vaccinate another hundred thousand people (matched
and randomised) – and then see what happens. Then you will know how well your
vaccine works.
This
is a requirement of all other forms of medical intervention (with provisos),
but it is not a requirement for vaccines. A true efficacy study does not simply
look at a ‘surrogate’ marker. It needs to study hard endpoints e.g. how many
people are truly protected against the disease. Also, what the rate of adverse
events may be.
Of
course, there are those who think that such a trial would be ridiculous and
unethical. Here, I quote from a website KevinMD:
‘….as some have actually
demanded, we must have a randomized controlled trial (RCT), the gold standard
of clinical research. RCTs use random assignment of subjects to one group or
the other, in this case vaccine or a placebo (fake vaccine), and ensure both
the subjects and evaluation team be blinded to who got what.
Think about this for a minute.
They are demanding parents agree to subject their child to a trial in which
they have a 50/50 chance of getting a fake vaccine. All this to satisfy the
concerns of vaccine deniers.
It would be incredibly
unethical to do such a study, and no institutional review board (aka human
studies committee) would ever approve such a thing. For such trials, there must
be reasonable uncertainty about which group is getting the better treatment,
and in this case, there is none. The bottom line is any vaccine skeptic who
demands proof like this is being massively disingenuous. It’s akin to demanding
a randomized controlled trial of parachutes.’ 6
What is being said here is that there is no uncertainty that vaccines
work, so there is no need for a randomised controlled trial. The counter
argument to this is simply to turn the argument inside out. Without an RCT, how
do you know that vaccines work? Where is your evidence? Or does ‘just knowing that it works’, count?
Medicine is littered with examples of
interventions that were considered so inarguably beneficial that no trials were
ever done. Strict bed rest following an MI, the radical mastectomy, x-ray
screening for lung cancer, PCI in the non-acute setting.
Bernard
Lown was a man who dared challenge the ‘unquestionable’ benefits of coronary
artery bypass surgery. He had a long and arduous battle to publish his evidence
that CABG may cause more harm than benefit. His blog on this, ‘A Maverick’s
Lonely Path in Cardiology (Essay 28)’, is well worth a read. As he concludes:
‘A new treatment, whether
involving drugs or procedures, is improper without indubitable supporting
evidence of benefit. The patients’ well-being must not be compromised by
imagined good when countervailing interests are at the same time being served.
Our forty-year struggle essentially concerned medicine’s first and inviolate
principle, primum non nocere. “First do no harm” is the litmus test sanctioning
the privilege to practice medicine.’ 7
Bernard Lown is one hundred
per cent correct, and I find it difficult to conceive that anyone who has the
slightest understanding of science could write the words ‘The bottom line is any vaccine skeptic who demands proof like
this [an RCT] is being massively
disingenuous.’
Disingenuous… Personally, I demand
proof like this for all medical interventions, wherever possible, and so should
everyone else. The reason why, is because evidence from controlled clinical
trials (with all their inherent flaws) is the only tool that we possess to properly
assess benefit vs. harm. Without such evidence we are simply hoping and praying
that benefits truly outweigh any downsides.
For example, with the
Pandemrix vaccine. Had an RCT been done, it is possible, even probable, that
the adverse impact on Narcolepsy would have been picked up. Therefore, it would
not have been used, therefore many thousands of people would not have been
harmed – above and beyond narcolepsy. Some of the key issues around Pandemrix
were discussed in the BMJ article ‘Pandermix vaccine: why was the
public not told of early warning signs?’
‘Eight years after the pandemic
influenza outbreak, a lawsuit alleging that GlaxoSmithKline’s Pandemrix vaccine
caused narcolepsy has unearthed internal reports suggesting problems with the
vaccine’s safety.
‘…the raw numbers of adverse
events were not small. Although it is often said that perhaps only up to 10% of
adverse events are reported to national reporting systems, by late November,
GSK had received 1138 serious adverse event reports for Pandemrix—a rate of 76
per million doses administered. By mid-December, there had been 3280 serious
adverse event reports (68/million doses). The last report seen by the BMJ,
dated 31 March 2010, shows 5069 serious adverse events for Pandemrix
(72/million doses).’ 8
As
the article goes on to say:
“What is the purpose of
pharmacovigilance if nobody is acting on the information? This information took
eight years to come to light through academic work and litigation. Is this
acceptable? If the information at our disposal is partial, that is the direct
consequence of secrecy, which should not surround any public health
intervention.”
Pandemrix and Arepanrix were
designed for a pandemic and were removed from global markets after the
pandemic. Whatever adverse events they may have caused, they are vaccines of
the past. But the events of 2009-10 raise fundamental questions about the
transparency of information. When do public health officials have a duty to
warn the public over possible harms of vaccines detected through
pharmacovigilance? How much detail should the public be provided with, who
should provide it, and should the provision of such information be proactive or
passive?’
All good questions.
Had
Pandemrix not caused narcolepsy in large numbers, litigation against GSK would
not have taken place – in Ireland. Had this not happened, data about the high
rate of other adverse effect would never have seen the light of day. It seems
that the European Medicines Agency had little interest in the matter.
‘What EMA knew—or could have
known—about the comparative safety of GSK’s pandemic vaccines is hard to
discern. It told The BMJ that “EMA does not perform comparative benefit and
risk evaluations between products approved in the EU, or between EU products
and products approved or used outside the EU.”
So,
if monitoring product safety is not of interest to them, what exactly do the
EMA do? Central here, however, is the fact that we had a vaccine causing a high
number of serious adverse events and no-one did, or said, anything. Had there
not been a lawsuit, we would still have been unaware of any problems. At least
that is my understanding of what happened here.
Does
anyone care? Well, in many countries you cannot even sue the manufacturer if a
vaccine damages you – as also mentioned in the BMJ article.
‘Another element, adopted by
countries such as Canada, the US, UK, France, and Germany, was to provide
vaccine manufacturers indemnity from liability for wrongdoing, thereby reducing
the risk of a lawsuit stemming from vaccine related injury.’
Quite extraordinary. In my view, beyond extraordinary.
A
manufacturer makes a product that you believe may have damaged or killed a
loved one, and you cannot do anything about it. Or, those who made the product
cannot be sued. In banking they have a phrase for this. They call it moral
hazard.
‘lack of incentive to guard
against risk where one is protected from its consequences, e.g. by insurance.’ In
this case no insurance is required. Governments have given pharmaceutical
companies a free pass. Depending on your belief in the inherent ethical
standards of pharmaceutical companies you may – or may not – find this
reassuring.
Personally, I find it extremely
worrying that people, and the entire medical profession, appear willing to
accept that all vaccines, for all conditions, are entirely effective and have
no adverse effects…. Even when it has been demonstrated, beyond doubt, that
they do.
Anyway, I feel I should
probably stop here. Others have gone much further than me, others have been
braver. But there should be nothing ‘brave’ about asking legitimate scientific
questions. As Richard Feynman
said. ‘I would rather have questions that can’t be answered than answers
that can’t be questioned.’
—
2:
Doctoring Data pp 228 – 9 ISBN 978-1-907797-46-0
Reprinted from DrMalcolmKendrick.org.
Copyright © 2019 Dr. Malcolm Kendrick
