Vaccines – Kendrick on benefit, risk and moral hazard

By Marika Sboros

Scottish GP Dr Malcolm Kendrick wades once more into the murky, stormy waters of vaccines. He targets the drug industry, medical profession and researchers that enthusiastically promote vaccines – without robust evidence on safety.

He opens with a quote from John Locke’s A letter concerning Toleration: “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.” 

That sets the tone for a topic not liberally endowed with free-speech options.

This is Kendrick’s second blog on vaccination and he thought just as long and hard about the first as this one. He says that vaccination is the most brutal area for discussion that he has ever seen. He calls it a “reputation shredder”.

Dare to hint of the slightest issue with any vaccine and people come down upon you like a ton of bricks, he says.

That’s putting it mildly because they don’t stop even after flattening you with bricks. They stamp on your head over and over to ensure that they have shut you up forever.

That’s said figuratively, of course, and it’s not figurative hyperbole. Kendrick knows that by daring to write on this subject, there will “inevitably be people moving behind the scenes” to take down his blog.

But Kendrick is made of sterner stuff and he is no “anti-vaxxer”.

Anti-vaxx is a defamatory smear that drug industry-led MDs and others resort to when they lack scientific, moral or ethical argument against a colleague. Ditto for anyone who dares to suggest that, like all pharmaceuticals, vaccines just may have a teeny, tiny downside.

First, do no harm

Kendrick writes against the backdrop of a changing, unstable, increasingly authoritarian world. It is one, he says, where all governments are about to pass laws mandating vaccination for everyone. It is one in which they levy fines or fire people for speaking out about or refusing vaccination.

Once something becomes mandatory any research into possible harms moves strictly off-limits, he says. And when that happens, we need to be absolutely 100% certain there is no possibility that we may be doing harm. Or that we are reducing any potential harm to the lowest level possible.

Click here to read: Tim Noakes REALLY ‘anti-vaxx’? Fat chance!

 

In his blog, Kendrick takes aim at the pharmaceutical industry and governments who give the industry a free pass. His book, Doctoring Data, How To Sort Out Medical Advice From Medical Nonsense, is a must-read.

He also targets MDs who act as industry proxies. And he reminds them of an important principle that many appear to have forgotten – and probably wrongly attributed to Hippocrates.

It is primum non nocereLatin for above all, first do no harm.

Kendrick is not alone among MDs who believe that we must discuss the risks of vaccines.  But he is one of few  globally brave enough to say so in public. The recent death of a top UK top cancer researchers, Prof Martin Gore, following a “rare reaction” to a yellow fever vaccination, should be a spur, he says.

Read a media report on Gore’s death carefully enough,  Kendrick says, and it “becomes inarguable that the yellow fever vaccine was the direct cause of his death”.

So, buckle up and read on for another provocative look at essentially vexed questions: Can vaccines do harm? And if so, what price is worth paying for that harm?

By Malcolm Kendrick

 ‘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.’ 

A tragedy for a brilliant medical researcher and his family.

However, even here, we can see the toning down and deflection of any criticism of vaccines. The writer carefully avoids the words ‘caused by’. The report states that he died following a yellow fever vaccination. Which could mean that he had a vaccination 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.’ (Doctoring Data pp 228 – 9 ISBN 978-1-907797-46-0)

Vaccines – price worth paying?

Yes, the numbers are relatively small – although by no means vanishingly small. In a 15-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.

My 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 we should restrict personal liberties 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 and 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 

These are not my words; these are the words of the PEI.

‘Potential brain damage’

This list obviously raises the issue of potential brain damage following vaccination. It’s something that we saw 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.’ (Doctoring Data pp 228 – 9 ISBN 978-1-907797-46-0)

A finding not seen in any safety testing prior to the launch of Pandemrix.

Thus, vaccines can not only cause severe reactions up to and including death. They can also lead to neurological damage, such as narcolepsy. Is this specifically to do with the vaccine itself, the preservative it is carried in or something else?

Who knows?

Yet despite apparently indisputable evidence that vaccines can and do cause neurological damage we can find articles such as below. I chose it pretty much randomly but it sums up 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. 

Vaccines – myth versus reality

‘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”.

What the authors state 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.’

This is… I am not sure what it is.

Vaccines versus autism

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 in 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 led 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.  (Doctoring Data pp 228 – 9 ISBN 978-1-907797-46-0)

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 vaccines may aggravate this problem, with potentially serious consequences.

Vaccines may aggravate mitochondrial dysfunction?

Some researchers believe that narcolepsy, for example, is 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. And that various viral infections and, therefore, possibly vaccination, are triggers.

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, such as chicken pox, or rubella (in boys) in these individuals.

To me, these things seem eminently sensible areas for study.

Paradigm trap?

However, it seems that we are trapped within a paradigm where it is impossible to suggest an association between any vaccine with or cause of 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 the crushing of what I believe to be important and valid questioning, 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 are 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.

Raising red flags

Any of these things should be a very large red flag.

Looking specifically at efficacy, on that list, the experts usually state 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 who previously had vaccination suffered from measles.

Which means that we need to read very carefully the statement from the Vaccine Knowledge Project…. and provides evidence that the vaccine can actually reduce the number of cases’. We could take that to mean: ‘provides all the evidence needed’ – which is what those who crafted it have implied.

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, then vaccinate 100,000 people against a disease. Do not vaccinate another 100,000 people (matched and randomised). And then see what happens.

The real test

Then you will know how well your vaccine works.

This is a requirement of all other forms of medical intervention (with provisos) but not for vaccines. A true efficacy study does not simply look at a “surrogate” marker. It needs to study hard endpoints, such as 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.’ 

What that says here is that there is no uncertainty that vaccines work. So, there is no need for a randomised controlled trial. The counter-argument is simply to turn it inside out:

Myth versus evidence

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 the experts considered so inarguably beneficial that no trials were ever done. These include strict bed rest following an MI (myocardial infarction, aka heart attack), the radical mastectomy, x-ray screening for lung cancer, PCI in the non-acute setting.

Bernard Lown was a man who dared to 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.

The real bottom line?

His blog on this, A Maverick’s Lonely Path in Cardiology, 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.’

Bernard Lown is 100% 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 is because evidence from controlled clinical trials (with all their inherent flaws) is the only tool that we possess to properly assess benefit versus harm. Without such evidence, we are simply hoping and praying that benefits truly outweigh any downsides.

For example, with the Pandemrix vaccine, if researchers had done an RCT, it is possible, even probable, that they would have picked up the adverse impact on narcolepsy. Therefore, it would not have been used. Therefore, many thousands of people would not have been harmed – above and beyond narcolepsy.

The key issues

A BMJ article, ‘Pandermix vaccine: why was the public not told of early warning signs?’ discussed some of the key issues:

‘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).

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.

Product safety

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 effects 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 does 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.

Vaccines and the ‘moral hazard’

 

A manufacturer makes a product that you believe may have damaged or killed a loved one and you cannot do anything about it. Or you cannot sue those who made the product.

In banking, they have a phrase for this. They call it moral hazard, a “lack of incentive to guard against risk where one is protected from its consequences, e.g. by insurance”. In this case, there is no requirement for insurance. 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.”