Does Sars-Cov-2 exist?

I ask this question because a number of people have claimed the entire Covid pandemic was a made-up event. A ‘plandemic’ If you like. There was no new virus, it never existed. Others question whether or not viruses actually exist, as ‘they have never been seen.’ I get these comments quite a lot on my blog. I also see people on X, and elsewhere, making similar claims. Conspiracy theory?

I am also often accused of being a conspiracy theorist. That lazy, lazy, form of attack, which never requires any evidence. Nor any attempt to define what a conspiracy theorist may actually be. It is just a ‘catch all’ insult and dismissal. Which continues to be enormously effective. Strangely.

However, when we get into the ‘viruses don’t exist,’ or ‘Sars-Cov-2 doesn’t exist’ territory, I too find myself tempted to dismiss such comments as a conspiracy theory. I try to resist. Everyone is entitled to their opinion. But …

Here I want to try to explain why it is that I am pretty much one hundred per cent certain that viruses exist and that Sars-Cov-2 was a new strain/variant of coronavirus not seen been before.

Do viruses exist?

Some may think this is a stupid question to ask. ‘Of course they exist …you idiot. Don’t you know anything.’ However, it is always worthwhile taking the time to challenge things you believe to know, to be sure. If not all the time, then at least from time to time. A stress test, if you like.

After all, most people are convinced that a raised cholesterol level causes heart disease, and there appears to be a vast mountain of data to support this hypothesis. Only an idiot, or conspiracy theorist, could think otherwise.

Well, ahem, disclosure of interest …. I have spent forty years studying this area, and I am absolutely certain that cholesterol (or LDL – Low Density Lipoprotein) does not cause heart disease. If the mainstream medical research world can get it wrong about something this fundamental, then perhaps they can be wrong about other seemingly inarguable facts?

One of my somewhat geeky hobbies is studying medical ideas from history, which turned out to be complete bunkum. There are many. They include the knowledge that blood does not circulate round the body, that Miasma causes infectious diseases, and the absolute requirement for strict bed rest following a heart attack. To name the first three that spring to mind.

One thing I learned very early on was that the person who first dared challenge the prevailing dogma would be ruthlessly attacked, their reputation stomped into non- existence. Or, in the case of … ‘could doctors please wash their hands to stop spreading horrible diseases’ Semmelweis … beaten to death in a secure mental hospital.

Luckily, someone would finally come along to change things around. Who then succeeded in garnering all the praise. But how did they succeed when others ended as smoking ruins? I have never really managed to work this out.

I certainly wish I knew. Perhaps it was simply a combination of time and persistence. Maybe those who succeeded had terrific communication skills. Maybe the pile of contradictory facts simply grew too enormous to be ignored?

Alternatively, it could be that those established ‘experts’ who had most to lose grew old and gave up the fight to maintain the status quo – then died. As Max Plank once remarked. ‘Science progresses one funeral at a time.’

Back to viruses – and their existence

Here follows information that I can find no reason to doubt.

The first virus ever to be identified was the tobacco mosaic virus. To be more precise, an ‘agent’ was identified. Something far smaller than a bacterium. It was initially called ‘Contagium vivum fluidum.’ Which sounds like something from Harry Potter. A rough translation could be: ‘a contagious living thing that can move about – and infect, and harm, living things.’

Early researchers could not see it, whatever it was. But they knew it had to exist because of the carnage it left behind on their highly valuable tobacco plants. They had previously worked out how to fix bacteria in a gel, which gained bacteria the name ‘contagium fixum.’ And bacteria could be seen under an optical microscope. At least from the late nineteenth century onwards.

However, this agent could not be fixed, nor seen. So, it had to be something else, very, very small – perhaps not even a solid. Which is why we ended up with the term fluidum.

Beijerinck, in 1898, was the first to coin the term, ‘virus’. Virus is Latin for poison or noxious liquid. Which is not a terribly accurate name for a tiny wee solid thing.

‘Investigating the cause of mosaic disease of tobacco, previously shown to be an invisible and filterable entity, Beijerinck concluded that it was neither particulate like the bacteria implicated in certain infectious diseases, nor soluble like the toxins and enzymes responsible for symptoms in others. He offered a completely new explanation, proposing that the agent was a “living infectious fluid” whose reproduction was intimately linked to that of its host cell.’¹

That last bit about reproduction was certainly a good guess. As for the living infectious fluid bit … not so much.

However, it was not until the 1930s that anyone started to pay much attention to ‘viruses.’ No-one knew much about them, even if they truly existed. Virology wasn’t a research area until the second half of the twentieth century,

The first time a virus was ever spotted was in 1939. This was almost immediately after the first electron microscope was created, by Siemens, in 1939. You could say that that the moment it became technically possible to see a virus, they were seen. And lo, vaccination was born. Sorry… couldn’t resist.

Thus, when people state that viruses have never been seen, I tend to sigh gently to myself. This is simply not true. You can see hundreds of different types. Thousands, even millions.

A CORONAVIRUS

For the last eighty-five years, we have been seeing them in ever greater detail. You can also grow a virus in the lab. You can define their exact RNA, or DNA, sequence. You can construct a new virus from lab created RNA – if you so wish.

In addition, you can add bits to existing viruses to make them more, or less, infectious to humans. This is known as gain of function research. In many ways there is little that we don’t know about them.

We know what they look like, how they replicate within host cells, what their gene sequence is, how they attach to cells in order to gain entry. Yet, and yet, their ineluctable essence remains difficult to grasp.

In what direction, exactly, will they mutate? Why do they sometimes spring back to life? I am thinking of my cold sores here. Will they jump across from animal hosts to kill us all? And why don’t we have any decent drugs to stop them being so damned deadly? I am thinking more Ebola here.

It is simply because they are so tiny, that is hard to get a handle on them. They float around us, unknown and in important ways unknowable. I remember reading an article where someone tried to work out, at the peak of the Covid pandemic, how large a container you would need to hold all the Sars-Cov-2 viruses in the world.

The answer was, a can of Coke, as reported by the BBC.

‘If you collected up every Sars-CoV-2 virus particle in the world, it would fit inside a soft drinks can.’ ²

Which I find pretty mind-boggling. It also gives you some idea of how small they are. And how little, in terms of volume, is required to infect and potentially kill someone. But what of Sars-Cov-2 itself. Is it real, was it real, was it a new virus that had never been seen before? I believe the answers here to be yes, yes, and yes.

The evidence that supports Sars-Cov-2 as a ‘new’ virus

You can argue about when a new strain of an existing virus becomes a distinct ‘new’ virus. Or even what to call each variant. Naming things has never been a precise science:

‘The issue of naming the coronavirus had arisen about twenty years back and the need for a standard nomenclature system was asserted after the emergence of SARS in 2002–2003 . However, the issue resurfaced in early 2020 when a novel coronavirus (SARS-CoV-2), deadlier than the previous, brought the world to a halt. Over the years, no solid standard naming system has been developed and implemented.’ ³

But, for now, I will say Sars-Cov-2 represents a distinct ‘new’ virus and leave it at that. Clearly coronaviruses themselves are not remotely new. They have been around, and known about, for a long time. They are called a ‘corona-virus’ because of the crown, or halo, of protruding spikes (the spike protein). There are four main subgroups. Alpha, beta, gamma and delta – although this will doubtless change. I think it may have already happened.

They can infect other animals. Cats, for example, die from coronavirus infections. In humans they have been causing the common cold for many years.

Coronaviruses are an RNA virus, which means they only contain a single strand of genetic material. Some viruses have DNA – two strands. DNA viruses mutate relatively slowly. However, RNA viruses tend to mutate rapidly, and veer all over the place. Which means that:

Vaccines are likely to become ineffective pretty rapidly (see under influenza)
They can more easily avoid host immune defences, so you can become infected again and again.

Be afraid of the mutations. One form of coronavirus that mutated was MERS-CoV. [Middle-East Respiratory Syndrome – Coronavirus]. It had a reported infection fatality rate of thirty-five per-cent. It came, it is believed, from camels. MERS scared the bejesus out of the virologists. Luckily it did not prove highly infectious between humans. So, it faded away. Although it has not gone.

We also had SARS-Cov-1 (Severe Acute Respiratory Syndrome – Coronavirus, mark 1). Which kicked off in 2002, in China – quelle surprise. It spread to nearly thirty countries but caused only nine hundred reported fatalities. Why did it not kill more, and spread more widely? The widely believed answer is that it was only infectious – could only be passed on – when people had symptoms. So, if you isolated people who had symptoms, no-one else got infected. End of viral spread.

Then we had Sars-Cov-2, or Covid19, or just Covid. Call it what you like. It was new. Why do I believe this?

One of the main reasons is because I had very direct experience of the effects it had. I was working on the front line during Covid, helping to manage the elderly in rehabilitation units and nursing homes. I went in, every single working day. I saw over thirty people die of this ‘new’ virus. Possibly more. I kind of lost count.

Their deaths were often strange. I have seen a lot of people die over my decades working as a doctor. Some sudden, mostly slow. But with Covid people died ‘differently’. The most unusual thing was when their oxygen saturation levels – the amount of oxygen contained in red blood cells – started to fall, dramatically. Despite this, they often had no symptoms.

Maximum oxygen saturation is 100%. People with a level of 80% are in trouble and need to get into hospital a.s.a.p. They will be struggling badly and usually need oxygen. With Covid, I was sticking on a probe and getting levels of 70%. Which would normally mean – almost dead, or just about to die. Instead, there was nothing to see. Breathing rate normal, fully conscious and alert. Smiling and chatting even.

Then, less than ten minutes later, in two cases. Dead. Bang, gone. What the …?

This observation, of very low saturation levels in otherwise well people, was described all over the place. According to what I had been taught, it should not have been possible. But clearly it was, because it happened.

Here from the University of Boston. ‘Three Reasons Why COVID-19 Can Cause Silent Hypoxia.’

“We didn’t know [how this] was physiologically possible,” says Bela Suki, a BU College of Engineering professor of biomedical engineering and of materials science and engineering and one of the authors of the study. Some coronavirus patients have experienced what some experts have described as levels of blood oxygen that are “incompatible with life.” ⁴

Then there was the sudden loss of smell. Our next-door neighbours have five boys. One of whom was working in Macao at the start of it all. He came back in March 2020. The boys all then reported sudden loss of smell. One of them farted and the others could smell nothing. They were otherwise well.

Pretty much the same thing happened with my son. It started when my wife cooked him some scrambled eggs and they tasted of almost nothing. About which he complained bitterly. Then, everything tasted of nothing. Apart from things the tongue can sense. Salt, sweet, bitter, sour and umami. Then my daughter, who did have symptoms of Covid, lost her sense of smell completely. She was working as a junior doctor on a Covid ward in Wales.

This occurred very early on, before anyone had even mentioned loss of smell, or very low oxygen saturation accompanied by a complete lack of symptoms. This was not a case of me seeing things I had been told I would see. These were signs and symptoms that I had neither come across, nor read about.

I knew very early on that a loss of taste/smell was diagnostic of Covid. It was ‘pathognomonic’, to use the medical term. Although it took about nine months for this symptom to be accepted by the mainstream. Having said this, it never happened to me, despite the fact that I was surrounded by Covid every working day, for months. And I lit up Lateral Flow Tests from time to time.

Anyway. To see one set of symptoms you have never seen before could be considered coincidence. To see two. that’s new. Then there were the blood clots, and the cytokine storms. Yes, the latter two can be seen with other viral infections. But not to the same extent. To my mind, these were also new, at least in their intensity.

You would have to work pretty damned hard to convince me that Covid was not a new disease, caused by a new virus Sars-Cov2. Things that you have never seen before, seen with your own eyes, tend to be the most convincing.

More science

More scientific support for the fact that Sars-Cov2 comes from the way it caused damage, and the specific type of cells that it damaged. Which fits with the known structure of the virus itself.

One fascinating thing about viruses is how they manage to gain entry to a cell. In almost all cases they attach to a protein, or proteins, on the cell membrane. This allows them to be absorbed/invaginated into the cell. This represents a ‘lock and key’ mechanism.

HIV, for example, locks onto a receptor called the ‘C-C chemokine receptor type 5 (CCR5’). Then, and only then, is it granted entry from the outside world into the cytoplasm – the inside world of a cell.

There are some people, not many, who have a mutation of the CCR5 protein called the Delta-32 mutation which prevents CCR5 from being expressed on the outside of the cell membrane. So, HIV cannot attach, therefore you cannot get AIDS.⁵

The Ebola virus also attaches to CCR5 protein. If you have the Delta-32 mutation, you can’t get HIV or Ebola. Or to be slightly less black and white, you are almost entirely resistant to them. There is now much work being done in the area.

‘The triad “CCR5, extracellular vesicles and infections” is an emerging topic.’ ⁵

It is why viruses that affect animals e.g. bird flu, usually cannot infect us. We have different proteins on our cells. There is no lock, and therefore entry is barred. However, if the virus mutates just a little bit, then you can end up with a key that fits a human lock and then … watch out. Species jump is what keeps virologists awake at night. Ebola is a species jumper. Luckily, it does not spread very easily.

When it comes to Sars-Cov-2, the virus gains entry to human cells by attaching to a protein known as the ACE2 receptor. A common protein/receptor found on many cells. Once the virus latches on, this triggers downstream processes that ‘open up’ the cell to viral entry. The specific ‘key’ in this case is the S1 protein that sits on the spike protein.

As a quick jump sideways, the lock and key system is precisely how LDL molecules gain entry into cells. They attach to a protein receptor ‘lock’ known as the LDL receptor. The key here is the ApoB-100 protein ‘key’, which is attached to all LDL molecules. After locking onto the protein receptor, the LDL molecule is accepted into the cell. LDL molecules and viruses are just about the same size. [Getting into a cell would be impossible for either of them, without a magic key].

Anyway, back on track. Certain cells in the body have far more ACE2 receptors than others. They are most abundant in ‘epithelial’ cells lining the lungs, blood vessels and the small intestine.

‘ACE2 was shown to be abundantly present in human epithelial cells of the lung and enterocytes of the small intestine as well as in endothelial cells of the arterial and venous vessels.’⁶

Knowing the type of cell that Sars-Cov2 is designed to lock onto you would expect to see the following triad. Lung damage, diarrhoea (caused by damage to cells lining the intestine) and vascular damage – creating blood clots, causing heart attacks and strokes and suchlike. Which is exactly what we did see.

Once you knew that the new spike protein fitted perfectly onto ACE2 receptors, it became possible to predict what would happen. Including, almost certainly, the loss of sense of smell, caused by damage to the ‘epithelial’ lining of the nose.

At this point I am not sure what else I can say. I think the evidence is overwhelming that viruses exist. Equally I find it virtually inarguable that Sars-Cov2 is/was a new coronavirus not seen before. We can see it, we can grow it, we can test for it, and it causes damage predicted by the type of cells it gains entry to – and therefore kills.

Was it made in a biolab in Wuhan, or did it start off in a wet market in Wuhan – having evolved from a bat virus – then travelling a thousand miles across China … without any sign of it on the way? Dum de dum, taps fingers on desk.

I shall let you decide on that one. Bear in mind that the biolab leak explanation would place greater blame on China, and the Chinese authorities are the only ones who have the evidence to support, or fully refute, this theory … So, I wouldn’t hold my breath on that on. But in many ways, it doesn’t’ really matter where it came from. It was a virus, it was new, it arrived. It did its thing.

Although, having just said that, the main purpose of an enquiry should be to try and learn how to stop bad things happening again. If the virus was made in a lab, and then escaped, we need to ensure that man-made viruses like this never escape again. Or are never made again?

Alternatively, if the virus evolved on a long and winding road across China, on its way to a wet market, well, we probably need to ask China, and other countries with wet markets to close them down. Or do something else. Not quite sure what the something else would be. Autoclave all bats? Death to all pangolins?

Summary

I never like to say that something is true, or false, or a fact, as this makes it very difficult to examine that thing again with an open mind. I prefer to define ideas as probable, possible and unlikely. However, I will say that it is just about 100% certain that:

Viruses exist.
Sars-Cov2 was/is a ‘new’ version of a coronavirus.

Next, the reasons why I believe that many people were convinced that Covid was a plandemic. And remain convinced of it, to this day.

1: https://pubmed.ncbi.nlm.nih.gov/30003445/

2: https://www.bbc.co.uk/future/article/20210210-why-the-entire-coronavirus-would-fit-in-a-can-of-coca-cola

3: https://pmc.ncbi.nlm.nih.gov/articles/PMC8577721/

4: https://www.bu.edu/articles/2020/3-reasons-why-covid-19-can-cause-silent-hypoxia/#:~:text=Despite%20experiencing%20dangerously%20low%20levels,of%20breath%20or%20difficulty%20breathing.

5: https://www.sciencedirect.com/science/article/pii/S0168170220302938

6: https://pubmed.ncbi.nlm.nih.gov/33626315/

THE KENDRICK COVID ENQUIRY (As I humbly call it)

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Part One (a): Are the facts, facts?

‘The great enemy of the truth is very often not the lie, deliberate and contrived and dishonest, but the myth, persistent, persuasive and unrealistic.’ John F. Kennedy.

I do not think that anyone can write about Covid without first recognising that the facts, may not actually be ‘the facts.’

My trust in medical research has been gradually draining away for the past forty years or so. I am uncertain how much remains. I do not have a handy ACME ‘trustometer’ to slap on my forehead, but I sense my levels are certainly below fifty per cent – and falling. I shall let you know when they reach zero.

There was certainly a rapid drop during Covid. Accelerated by the emergence of ‘fact checkers.’ If a group of people could be more ironically named, then I would love to hear of them. The idea that someone can be an officially verified ‘checker of the facts’ is so inimical to science that they should have been laughed out of existence the moment they appeared. Sadly not. Soviet Union anyone?

Richard Feynman believed that the very definition of science is the process of questioning, and that scientists must be sceptical. Or, as he once said. ‘Science is the belief in the ignorance of experts.’ I have regularly been ‘accused’ of being a professional sceptic. My reply is usually ‘thanks, I consider that a great compliment. You, on the other hand …’

As I delved into medical research papers over the years, one painful reality emerged. Which is that you need to be wary of the findings contained therein. I came to learn that, at least in certain cases, I only needed to look at which institution the research came from and who the authors were, to know which ‘camp’ they were in. At which point I could tell you everything the paper was going to say – to paraphrase. ‘We have found that everything we previously said was absolutely correct.’ No need to read it.

Of course, this only works for areas I have been studying for many years, where the terrain is very familiar. Give me a paper on quantum physics and I would have to read the whole damned thing. Then accept that I have not the slightest idea what they are talking about.

In the world of Covid research, two camps emerged very rapidly. There was ‘establishment’ camp, or the ‘accepted narrative’ camp and the ‘alternative’ camp’. Or, as I initially thought of them, the roundheads and the cavaliers [English civil war analogy – for my overseas readers]. As far I could tell, fact checkers were fully paid-up supporters of the roundheads.

Which meant that you could write an article wildly overestimating the infection fatality rate, and nothing would be said. The fact checkers would rouse themselves momentarily, then airily wave it through. However, dare to suggest the Infection fatality rate was lower than the mainstream view, and all hell would break loose. Or, at the beginning of the Covid sage, dare to suggest that the Sars-Cov-2 emerged from a biolab in Wuhan. ‘Off with his head’.

It didn’t take too long before I decided to rename the two camps the ‘Faucistas’, and the ‘Partisans.’ Although I know there should not be two sides in a scientific discussion. We are not at war. Those who question, and probe, have a vital role to play in science.

They, we, are trying to ensure that the accepted ideas are as robust as possible. If the mainstream facts are correct, they will resist all assaults. If they cannot resist, they should wither and die, to be replaced by something far stronger. Or at least that is how I hope it works.

This is a slightly long-winded way of saying that, when it comes to Covid the first thing you have to do with any ‘fact’ is to ask where it came from. A Faucista, or a partisan. Then apply the ‘Kendrick bias constant’ to determine its validity. A figure that only exists in my head, and even I am not sure what size it is, which way round it goes, or how to use it.

You also need to accept that research is often far from clear cut, and the findings may simply be … wrong. Twenty years ago, John Ioannidis published his seminal paper called: ‘Why most published research findings are false.’ It is one of the most widely read medical research papers, ever.¹

‘There is increasing concern that most current published research findings are false … Simulations show that for most study designs and settings, it is more likely for a research claim to be false than true. Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias.’

The prevailing bias. I like that term. Perfectly polite yet still damning.

Was he correct, are most research findings false? Well, he has his own biases, as we all do. I still like to believe that the majority research can be relied on, at least to some extent. Boring, but reliable – yet still boring. However, there are areas where he is right about the influence of prevailing bias. Places where findings are more likely to be false than true.

I believe that Covid became one such area very quickly. Within a matter of weeks, you were a Faucista – the group which certainly had the support of the vast majority. Or you were a partisan. We few, we happy few, we band of brothers.

I believe the polarisation in this area was so rapid and intense in large part because of the huge amount of money that was getting burned, and the need to justify that cost. The UK spent around four hundred billion pounds (~$500Bn) on Covid measures. Maybe even more – I think it was more. Enough to fund the NHS, in its entirely, for three years. The figure from the US was ‘officially’ four point six trillion. Four …point …six …trillion … gasp, thud.²

In addition to the money, there was the unprecedented disruption of everyday life. Far greater than anything seen outside a full-scale war. There was also the damage to children’s education and everyone’s mental health. The other diseases left undiagnosed and untreated, the massive debt and residual damage to public services, the clampdown on human freedoms … The list is long. More harm than good? That is the question.

A huge amount was at stake. So many reputations, both scientific and political, became bound to the ‘accepted narrative’ camp. If the narrative went down, so did they, with all hands-on deck. Thus, all the measures taken had to be found worthwhile, or at the very at least, excusable. ‘It was all very difficult, no-one knew what was going on. We had to do something … A big boy made me do it.’

Very rapidly, the Faucistas built themselves a mighty citadel, bristling with armaments, and fact checkers. Everyone within that citadel became hair trigger sensitive to the slightest perceived ‘enemy’ touch. Ready to react with ruthless bombardment. Along with personal attacks on whoever stated them.

The Great Barrington Declaration for instance, which proposed focussing protection on the elderly, and allowing the virus to take its course in younger populations. Where the risk of death was exceedingly low. This was universally condemned. Along with its authors. Here is one press release, out of many, many…

20 public health organizations condemn herd immunity scheme for controlling spread of COVID-19.

‘If followed, the recommendations in the Great Barrington Declaration would haphazardly and unnecessarily sacrifice lives. The declaration is not a strategy, it is a political statement… What we do not need is wrong-headed proposals masquerading as science.’³

‘Unnecessarily sacrifice lives…Wrong-headed proposals masquerading as science …’ Who dares pop their head over the parapet after such attacks? Only the brave, or foolhardy. As for debate … you must be joking. I was invited to talk at an anti-lockdown rally in September 2020, in Edinburgh. I gave a talk. The organiser was threatened with five years in jail. Luckily that has all gone very quiet.

Sweden, alone amongst European countries, decided not to lockdown, or perhaps you could call what they did lockdown ‘lite’. Schools, restaurants and bars remained open. People travelled on public transport. This approach, too, was universally condemned. It was stated that Dr Tegnell (chief epidemiologist) and Stefan Löfven (the prime minister), were…

‘…playing Russian roulette with the Swedish population,” Carlsson said. “At least if we’re going to do this as a people … lay the facts on the table so that we understand the reasons. The way I am feeling now is that we are being herded like a flock of sheep towards disaster…

… Leading experts last week were fiercely critical of the Swedish public health authority in an email thread seen by state broadcaster SVT, accusing it of incompetence and lack of medical expertise.’⁴

But the Swedes held out. Which took some nerve, whilst their own medical experts were screaming blue bloody murder in the background. Things changed. Now the accepted wisdom is that the Swedish people effectively locked themselves down, without being told to. Being such a great public-spirited people. ‘Oh yes, I think that fully explains their figures … ahem, don’t you?’

Why this change in outlook? From outrage to a widely accepted explanation, and a collective shrug. I suspect it may be that, in comparison to other European countries, Sweden ended up with a death rate below that of:

Bulgaria
Hungary
Bosnia Herzegovina
North Macedonia
Croatia
Montenegro
Georgia
Czechia
Slovakia
San Marino
Lithuania
Greece
Latvia
Romania
Slovenia
UK
Italy
Poland
Belgium
Portugal
Russia

They were within touching distance of Spain, Ukraine and France and – just to mention another Nordic country – Finland. Certainly, a long way below the US.

If lockdowns needed to be so harsh, or even instituted at all, why was Sweden not at the very top of this, and every other list? Answer, whisper it …. Because lockdowns were ineffective? ‘Off with his head.’

No, don’t be silly, it is because the Swedes locked themselves down. And here is the evidence … [insert non-existent evidence here]. Memo to self. Just saying a thing does not make it true.

‘Overall, there’s no evidence that Sweden had a “voluntary lockdown”. Mobility changed far less there than in most other Western countries.’ ⁵

But what was it that drove the lockdowns around the world?

The Covid Infection Fatality Rate?

The accepted narrative around Covid developed very rapidly. It is a highly contagious and deadly disease with an Infection Fatality Rate (IFR) of close to three per cent – you may have forgotten that figure. Perhaps you were unaware it ever existed.

The WHO provided an early estimate that eleven million Americans may die, discussed as part of a masterful essay by Jay Bhattacharya. One of the authors of the Great Barrington declaration, and now director of the National Institutes of Health. Oh, the irony. ⁶

The worldwide population is approximately eight billion. Using the initial WHO figures we would have seen two hundred and fifty million deaths. Equivalent to the Spanish flu – which is where I suspect the 3% figure was initially plucked from. Hospitals around the world would be overwhelmed. Millions would die if we did not act fast and hard. Something had to be done.

That ‘something’ was lockdowns. It included the widespread use of masks, restriction on travel, closed borders, closed schools, closed entertainment venues and restaurants, workplace closures, social distancing, test and trace, the rush to bring out vaccines, and so on. These actions became unquestionable and inseparable. All of them had to be equally defended.

Trying to get a handle on the Infection fatality rate

The three per cent IFR figure was downgraded rapidly and ended up hovering at around one per cent – or thereabouts. An IFR of one per cent means that, if one hundred people become infected with the SarsCov2 virus, then one will die. Is this … was this, does this remain a fact? At the start of Covid I became obsessed with trying to work out what the Infection Fatality Rate might be. Does it really matter?

I believe it drove everything. The 1% IFR is, to quote from Lord of the Rings: the one ring that finds them, and in the darkness binds them. If the IFR was 1%, then I think everyone can just about manage to assure themselves that all their actions were justifiable.

An IFR of 1% would have meant nearly three million deaths in the US, and well over half a million in the UK. Yes, it might not have been the Spanish flu, but ‘things’ obviously had to be done?

What about half a per cent? At this level the argument begins to look pretty damned shaky. An IFR of half a per cent, or below, would be the iceberg that sank the great lockdown ship Titanic. This, the IFR, is probably the most important fact that we need to establish.

Can we ever know the infection fatality rate of Sars-Cov2?

I know that most people would love a concrete fact here. Confirmation that the IFR of Covid was 0.213, or 0.934, or whatever. But I don’t think that is possible. Concrete facts here are very difficult to find. Or at least, facts that you can rely on. Read journal A you get one figure. Read journal B, and you get another. I can give you a thousand figures.

It also does very much depend on the age you are looking at. In the age group, nought to nineteen, the IFR was 0.00003% – in the first scientific paper that comes up on a Google search. That is three per million.

In the UK there are approximately twelve million in that age group. Which means that Covid may have resulted in thirty-six deaths. If, that is, everyone of that age ended up infected.⁷ Almost the same number who drown yearly – in that age group.

Moving back to the overall fatality figure rate, Imperial College London (ICL) in late 2022 concluded that it was 1.15%. But we already know which camp Neil Fergusion and the ICL was in. They were the original Faucistas. In this study they found that everything they said previously was absolutely correct. By the authority of … them.⁸

A well-known, and reasonably reliable worldwide resource is Worldometer, which kept a running count of Covid cases and deaths from every country. It stopped counting in April 2024. The grand totals on Worldometer, now frozen in time, were that there had been seven hundred million coronavirus cases worldwide, with almost exactly seven million deaths. Which represents an IFR of precisely one per cent.⁹

My goodness, independent verification that Neil Ferguson and Imperial College were bang on with their modelling. Well, Ferguson did predict an IFR of 0.9% but what’s 0.1% between friends. And if we look at China on Worldometer, it tells us we had almost exactly five hundred thousand cases, with five thousand deaths. Again, an IFR of one per cent, bang on.

Case closed? Hang on, you might wish to probe a little deeper into, for instance, the Chinese figures. According to Worldometer, the population of China is around one point four billion and there were five hundred thousand reported cases of Covid. Which means that one in three hundred people caught Covid [precise figure 0.36%].

In comparison, sixty per cent of the population in Greece caught Covid. Which is two hundred times greater. This seems a remarkably large difference. The sort of difference you may struggle to believe.

What of the death rates? China ended up with four deaths per million of the population. A figure very similar to DPRK (the Democratic People’s Republic of Korea), which had three deaths per million. Strange that.

In Greece, on the other hand, they had four thousand deaths per million. One thousand times higher than China.

As for total deaths.

Greece: with a population of ten million had 37,869 deaths.
China: with a population of one point four billion had 5,272 deaths.

Personally, I find one of these figures to be more believable than the other.

Turning back to the overall figures from Worldometer. There were just over seven hundred million reported cases of Covid in total. Which means that around 9% of the world’s population became infected. Seven hundred million out of eight billion.

This is a very long way off the ninety per cent figure that Neil Ferguson predicted in his model. He predicted 90%, Worldometer says 9%. Once again, a bit of an echoing gap.

If Worldometer is right, and only 9% of the population did become infected, and the IFR was 0.9%, the UK would never have seen five hundred thousand deaths – as predicted by Neil Fergusion in his hugely influential model.

His model was, essentially.

IFR 0.9%, percentage infected 90%. Population of the UK 69m:

69,000,000 x 0.9% x .9 = 558,900

However, if only 9% become infected, this figure falls by a factor of ten:

69,000,000 x 0.9% x .09 = 55,890

This is not a great deal more than a bad flu year.

Returning to the age group nought to nineteen, if only 9% of them became infected we would have seen four deaths instead of a possible thirty-six. Which would have made school closures and the social isolation of children virtually indefensible. Sorry, leave out the word virtually.

As you can gather, the overall rate of infection, and the IFR, are intimately linked when it comes to the overall impact of an infective disease. An issue little discussed. But do you think it might be important? Answer…yes.

Which facts are facts?

At this point I suppose I need to ask. Do you believe that the coronavirus figures collated by Worldometer are ‘facts?’ Or do you believe some of them are, and others are not. In which case, which ones would you like to believe. To quote the late, great, singer songwriter John Martyn. ‘Half the lies you tell me are not true.’

Wherever you look, there is uncertainly, and disagreement. Completely different facts and figures can be found everywhere. When it comes to IFR, John Ioannidis came up with an IFR figure of 0.23% for higher income countries.¹⁰

Nature published a figure ranging between 0.79 – 1.82% (for higher income countries). The average between 0.79 and 1.82 is 1.3%.¹¹ As you have worked out for yourself, 1.3% is nearly six times more than 0.23%.

Which IFR is correct? Which is a fact? And why did the Nature study only look at higher income countries? Surely lower income countries should have fared worse – in that they could not afford to lockdown, and did not, and the standard of medical care would have been significantly lower, so more should have died?

I suspect lower income countries were ignored because, on paper, they all had very low death rates. Or very low reported death rates anyway. Just to choose a lower income African country at random … Chad. They reported one hundred and ninety-four covid deaths out of a population of seventeen million. Which is eleven deaths per million. In fact, according to Worldometer, Covid passed Africa by.

How could this be? In most higher income countries people of African origin were significantly more likely to die than the surrounding population. In the UK, Black British had a mortality rate of 273 per 100,000. Whereas those identifying as White, had a rate of 126. Less than half.¹² [Figures from the office of national statistics, and as you may have noticed these figures demonstrate and IFR of 0.273% for Black British, and 0.126% for White British].

Given this, it is difficult to argue that Black Africans, in Africa, were genetically protected, in some way. Although, it has to be added that the average age in African countries is significantly lower than in, say, the UK – and that would have had an impact on Covid related deaths – although nothing that could remotely explain the reported figures.

I also lean towards Ioannidis because I believe him to be a well-established objective seeker of the truth. He has long been a thorn in the side of what I shall call, politely, ‘official narratives.’ Other researchers, and journals, have a strong tendency towards those twin curses of human thought. Confirmation bias and groupthink. As for the fact checkers, which figures do you think they prefer? The higher, the better.

Which leads us inevitably to the question who, or what facts, do you choose to believe … or not believe. In later articles I will tell you what I believe to be the most probable IFR for Covid. And I will tell you why this figure is reasonably accurate.

Before we reach that point, I want to highlight some more of the many issues that make it difficult to be certain about anything. There are so many of them. Just to list a few important ones:

PCR testing – how accurate is it/was it?
False positive, false negatives. Did they raise, or lower, the IFR?
How do you determine if someone died of Covid – or simply died with Covid?
How many times were people infected – and how much would this affect the IFR?
Could you be exposed to Covid, and brush it aside, without becoming ‘infected’ or raising detectable antibodies?
The impact of continuing to count Covid deaths for more than three years – over the lifespan of many different variants – did this create an artificially high IFR?
What protection did vaccination provide?
Financial benefits of diagnosing Covid, did this lead to overdiagnosis?
Could aggressive treatment have been damaging, and possibly fatal?
How many people reported they had Covid, when they did not?
Which countries may have been economical with the truth about their Covid statistics?
Does the Sarv-Cov2 virus exist?

Each of these issues represents a minefield, with conflicting ‘facts’ stretching to the far horizon. Each of them capable of shifting the IFR significantly – downwards.

Does this mean we can never really know what happened with Covid? Even to answer such a superficially straightforward a question as how many died is tricky. Indeed, most facts about Covid tend to crumble when you apply a little pressure. But I think we can navigate a course, or sorts.

Next. Starting with an easy one. Does the Sars-Cov-2 virus exist? Easy …?

1: https://pmc.ncbi.nlm.nih.gov/articles/PMC1182327/

2: https://www.gao.gov/products/gao-23-106647

3: https://www.bigcitieshealth.org/newsroom-great-barrington-declaration/

4: https://www.theguardian.com/world/2020/mar/23/swedish-pm-warned-russian-roulette-covid-19-strategy-herd-immunity

5: https://unherd.com/newsroom/the-myth-of-swedens-voluntary-lockdown/

6: https://www.jospi.org/article/88046-dr-jay-bhattacharya-reveals-stanford-university-s-attempts-to-derail-covid-studies?ref=truth11.com

7: https://www.google.com/search?q=what+is+0.00003%25+per+million&oq=what+is+0.00003%25+per+million&gs_lcrp=EgZjaHJvbWUyBggAEEUYOTIGCAEQBhhA0gEJMTUxNTlqMGo3qAIAsAIA&sourceid=chrome&ie=UTF-8

8: https://www.imperial.ac.uk/news/207273/covid-19-deaths-infection-fatality-ratio-about/

9: https://www.worldometers.info/coronavirus/

10: https://iris.who.int/bitstream/handle/10665/340124/PMC7947934.pdf?sequence=1&isAllowed=y

11: https://www.nature.com/articles/s43856-022-00106-7

12: https://www.gov.uk/government/publications/covid-19-reported-sars-cov-2-deaths-in-england/covid-19-confirmed-deaths-in-england-to-31-december-2020-report

What went on during Covid?

146 Replies

Brevity? [Not my strong point]

Today, it is almost as if it never happened. The time of COVID-19 (which I shall simply call Covid from here on). It came, it went, it is now ancient history. Hardly anyone wants to talk about it anymore. Why not? I suppose you could say, what’s the point? You can’t do anything about it. What is done, is done.

True, but maybe you can help to prevent most damaging things from happening again. Which, I think, remains mission critical, because there are strong signs that those who drove the Covid nonsense are itching to do it all, once more. If given half a chance. Monkeypox anyone? Or Disease X.

In the UK we have massive Covid enquiry going on. It consists of ten ‘modules’, one of which has been finally completed, the other nine grind on. The chair hopes to conclude public hearings by the summer of 2026. Yes, 2026… Four years after it the enquiry started. [I would place a small wager that this deadline will be missed].

After this, a majestic report shalt be written. Which will take several more years, no doubt? By which time we will all have lost interest or died of old age. Last time I looked, the enquiry had cost well over one hundred million pounds (~$125m). I guess it will end up costing close to quarter of a billion by the time it is finished. All taking longer to complete than WWII.

Sweden wrapped up their enquiry by February 2022, in well under two years. Done and dusted, before ours even got started. There is a summary of it entitled: ‘How Sweden approached the COVID-19 pandemic: Summary and commentary on the National Commission Inquiry’ ¹

The whole enquiry probably cost them a couple of million, at most. One thing that did amuse me can be found in the commentary paper written by Jones Ludvigsson, a professor of paediatrics. He mentioned that:

‘I think the Swedish COVID-19 commission inquiry is a well-written summary and critique of how Sweden approached the pandemic. The pandemic disrupted society and drawing lessons from the report is crucial for our future pandemic preparedness. Despite the importance of the inquiry, I have so far not met any colleague who has actually read the 1700 pages.’

What is the point of these enquires and their enormous reports if no-one ever reads the damned things. Not even the medical professionals who are most likely to be called up to deal with a pandemic in the future.

Or perhaps the unreadable length is the point. Create thousands of pages of dead, passive-voice writing. This will draw a veil over the events because no-one can raise the energy to find out who was responsible for anything.

No one can possibly doubt that the UK report will be far, far, longer than the Swedish one. It will also contain hundreds of recommendations. Probably thousands. When it is finally published there will a great, yet momentary, fanfare. For a whole day journalists will wave bits of the report in the air and announce its recommendations Without ever reading the whole damned thing, who could. After which it be filed, recommendations forgotten. The end.

In the meantime, any politician involved in the Covid shitshow can deflect all questions and criticism. ‘I cannot possibly comment until the Covid enquiry has concluded. And I do not wish to prejudice it in any way.’ Which is the perfect political defence.

As has been said by others over the years. If you want to ensure that no-one is blamed for anything, and nothing is done, then commission an enquiry. It kicks the problem so far down the road that everyone loses interest. ‘Oh yes that, I remember that… sort of.’

Or, to quote the fictional Sir Humphrey Appleby in the UK comedy classic Yes Minster.

‘Minister, two basic rules of government: Never look into anything you don’t have to. And never set up an enquiry unless you know in advance what its findings will be.’

However, I do think enquiries can be helpful, so long as they are done quickly. That the report is short, and no politician is allowed within a million miles of it. In my view we should all pay attention to what Winston Churchill had to say on writing reports.

With Covid there will be no short, crisp report. It will be a Leviathan, crushing every last vestige of interest beneath a million tons of dullness. Sentences will stretch far beyond the horizon. Subjunctive clause sir? Why certainly, I would like a hundred, in so long as it can be heretofore suggested that it may, or may not be appreciated that the wishes of the majority can be associated with the conditions subjected to the possibility that….thud.

It will most certainly lay the dead hand of bureaucratic language upon us. To use Churchill’s phrase, utilising ‘the flat surface of officialise jargon.’ With terms such as ‘considerations should be given to the possibility of carrying into effect…’

Despite my concerns about reports, I still think that an attempt to understand what went on during Covid remains highly important. We still need to try and understand how we ended up in, what I consider, a bloody mess.

We also need to understand what drove Governments around the world to thrash about in panic, using heavy handed authoritarian weapons to control the public, and silence dissent. With no discernible benefit to anyone. Only massive costs and long-term harms.

But official enquiries are going to tell you nothing of this. If you can summon the energy to read the Terms and Conditions of the UK report it does sound superficially reasonable. The sort of deadly dull thing that no-one can really disagree with.

Here are the stated aims²:

In meeting its aims, the Inquiry will:

a) consider any disparities evident in the impact of the pandemic on different categories of people, including, but not limited to, those relating to protected characteristics under the Equality Act 2010 and equality categories under the Northern Ireland Act 1998.

b) listen to and consider carefully the experiences of bereaved families and others who have suffered hardship or loss as a result of the pandemic. Although the Inquiry will not consider in detail individual cases of harm or death, listening to these accounts will inform its understanding of the impact of the pandemic and the response, and of the lessons to be learned;

c) highlight where lessons identified from preparedness and the response to the pandemic may be applicable to other civil emergencies;

d) have reasonable regard to relevant international comparisons; and

e) produce its reports (including interim reports) and any recommendations in a timely manner. [A timely manner…ho, ho]

What’s missing from these aims?

Just about every question you would wish answered. Plucking a few from the air:

What is the evidence that lockdowns did any good
What is the evidence that lockdowns were harmful
What is the evidence that wearing masks provided any protection
Were the models created by epidemiologists inaccurate, if so why, and why did we listen to them – and should we do so in the future
Should we have had a behavioural unit within SAGE (Scientific Advisory Group for Emergencies) which used messages of fear to control the public response
Were the vaccines rushed through without sufficient consideration to safety
Were experts who disagreed with the official narrative attacked and silenced when it would have been more effective to listen to them

Yes, these sort of questions. The sort that you probably would like to have answered. Questions that the UK enquiry will go out of its way to avoid. Instead, it will be almost entirely concerned about process. Which departments should have spoken to each other. Should there have been a different oversight committee. Not, God forbid, any analysis of outcomes.

I do not need to be Nostradamus to confidently predict that the only aspect of the response that will be criticised will be the one that allows everyone to be let off the hook. Namely, the astonishing ‘finding’ that we should have locked down sooner, and harder.

But, of course, it will be pointed out that this was no-one’s fault. At the time, it was not clear what actions should be taken, due to the rapidly changing situation that we all had to deal with. The end. Nothing to see here, move along.

One thing for certain is that there will be absolutely no attempt answer what is perhaps the key question. Did lockdowns do more harm than good? Or should we ever attempt them again?

Given the fact that you are not going to get any answers from the official channel, I am going to try and tell you, in plain language, what I think went wrong, and why, and how to stop them happening again. My report will be far from all inclusive, but I hope that it will be readable. And it will not cost quarter of a billion pounds. Unless someone is offering?

Next. Part one.

1: https://pubmed.ncbi.nlm.nih.gov/36065136/

2: https://www.gov.uk/government/publications/uk-covid-19-inquiry-terms-of-reference/uk-covid-19-inquiry-terms-of-reference

Finally – the end (of the trial process)

139 Replies

And so, we reach the final end to the court case. You may think it all finished months ago, not so. The final, final act is when we have the reading of the Statement in Open Court (SIOC). This took place Thursday the 5^th of December 2024. Which is five years and nine months after the articles in the Mail on Sunday were published.

I could not talk or write about the SIOC before it happened, or the Judge would be most upset and angry. And you don’t want an upset or angry Judge. I have also been constrained, until today, in what I could write or say. You may not think so, but I have. The entire legal process is exceedingly slow, controlling and thin-skinned. There can be no criticism of any aspect whatsoever. There we go.

You may wonder what a statement in open court (SIOC) is. I find myself virtually unable to put it in plain English because I am not entirely sure myself. The first thing to say is that the defendants in a libel case are not obliged to make any apology. Something I did not know until recently.

So, the Mail on Sunday, and/or Barney Calman did not need to apologise. And you will note that Barney Calman, the gentleman – and I use this word loosely – who devised and wrote the articles has remained tight lipped. The word ‘sorry’ has not, and I suspect never will, pass his lips.

Had you ever met him, this would not surprise you. The word unpleasant does not do justice to the man. In this case, he basically accused me of being a mass murderer and clearly thought it rather amusing. Oh titter, titter. ‘Yes, sweetie a dry martini would be gorgeous.’

In lieu of an apology, the party that wins the case – in this case me and Zoe Harcombe, are entitled to have ‘their’ statement read out in open court. This has to be signed off by the Judge and read out in court. Which means that it represents the approved ‘legal’ summary of the findings of the case. The defendants can argue for changes – and they have done so. But it is not far off what we wanted, if rather dull.

Our lawyers, Carter Ruck, who I must say have been utterly brilliant and clever, also crafted a Press release, to go along with the SIOC. It is below. Further down is the SIOC itself.

What are my thoughts on what happened? Firstly, the articles were clearly a hatchet job designed to destroy my reputation. And Zoe Harcombe’s reputation. And quite possibly drag the GMC in, so that I would lose my job. In Barney Calman’s own words ‘we’re planning a big takedown of statin deniers.’

But what did he base the take down on? At one point in the planning stages for the articles Barney Calman wrote. ‘I must admit I have not read Malcolm Kendrick’s book.’ Yes, he decided to attack me, without reading my latest book at the time ‘A Statin Nation’.

In court he also admitted he had not read any book or paper I had written. The only thing he managed to quote was some words from the back cover of ‘A Statin Nation.’ Pretty exhaustive research there, Barney.

My arguments and scientific papers were of no importance to him, for his mind was made up. Based on … a fly cover. At another point, during a WhatsApp conversation with a mysterious cardiology expert called ‘X’ he asked the question of her. ‘So, Kendrick is right?’ They replied. ‘I’ve never actually read him Mea Culpa.’

It seems that no-one involved in writing these articles had made any effort to find out what I had so say, about anything, I was to be found guilty of the terrible crime of – something or other. For which, I was to be duly punished. There could be no discussion, or argument. My guilt had been established on the basis of … nothing! Further clear evidence of my guilt was to be accused of authoring a scientific paper – which I had nothing to do with.

In truth the entire episode would have been funny, had it not been so serious. The Keystone Cops of the mainstream media world. Don’t bother to read anything, don’t bother to try and discuss anything with your intended targets. Get your facts wrong. Admit you have no idea how to read and understand clinical papers… in court under cross-examination. Then accuse Zoe Harcombe, who did a degree in mathematics at Cambridge, of making up statistics to suit her arguments.

Why on Earth did Associated Newspapers (the publishers of the Mail on Sunday) not give up immediately? It would sure as hell have saved them a lot of money. Amazingly, as long as two years after we sued it appears their lawyers had not bothered to speak to Barney Calman.

What actually happened?

In my opinion, or should I say ‘allegedly’ what actually happened here was that Barney Calman had heard from various cardiology experts that cholesterol and statin ‘deniers’ were causing people to stop taking their drugs. This was clearly a dreadful thing, ‘worse than the MMR scandal’ according to Professor Sir Rory Collins. Such people needed to be exposed for the dangerous idiots that they are.

Barney clearly thought this was the basis of a good story, as part of his ‘fake news’ series. Heroic researchers, such as Professor Sir Rory Collins had dedicated their lives to the good of humanity. Their brilliant and groundbreaking research had proved that statins were wonder drugs that saved thousands of lives and had no side-effects whatsoever. All the evidence supported this. Had Barney ever read any of it?

Despite this mountain of unimpeachable evidence, there were still this band of unscientific unbelievers who dared to question the mighty statins, and even the mighty cholesterol hypothesis itself. They needed to be crushed and humiliated in public, in one of the most widely read newspapers in the world.

Barney Calman almost certainly thought this would be a slam dunk. On one side he had lined up various professors, including the chairman of the British Heart Foundation itself. As icing on the cake, he got a quote from the Secretary of State for Health, Matt Hancock. A man whose knowledge of cardiology literally has no beginning.

On the other side he had a few pipsqueaks who were never going to able to fight back. Too costly and dangerous for them. The lawyers who checked the piece almost certainly thought the same thing. Yup, probably libellous, but we have all these professors supporting us. Off you go Barney, publish away – allegedly.

Bong!

We did fight back, and we won. We won because of the lazy assumption that all the ‘experts’ must be right. Therefore, we must be wrong. There was no need to check facts, or to find out what we were saying, or why we were saying it? Waste of time, clearly unscientific idiots.

To quote from the SIOC itself:

“in the context of the public interest defence, perhaps the most serious omission of Mr Calman was his treatment of the Claimants’ right-to-reply responses”. The failure to consider the responses and the materials in them properly was said by the Judge to have “rendered the right-to-reply process hollow and superficial”, and the Judge also described Mr Calman’s attitude towards the Claimant’s responses as “dismissive”.

Sadly, this is how a great deal of ‘scientific’ debate now takes place. There is the agreed mainstream narrative, and here are all the ‘experts’ who support it. They do not need to defend their position, they just band together to attack and ridicule anyone who dares question them.

Luckily, when you go to court, this defence counts for little. Judges are unimpressed by eminence. The ‘do you know who I am’ argument cuts little ice with them. I imagine Judges have seen enough eminent people spouting lies and rubbish to last a lifetime. Justice is, or at least tries to be, blind.

And so, the Judge decreed that Barney was talking libellous nonsense. The punishment for Barney? As our lawyers had predicted, almost immediately after the Judgement was made – he was promoted. This, allegedly, is the way that Associated Newspapers says *$%k you.

I can only hope that a little voice whispers into his ear at night.

What I mainly hope, and one of the main reasons why I took on this fight, is that ‘others’ will take note that. First, that you don’t attack me, or Zoe, ever again. More importantly, you cannot just spout libellous nonsense on the basis that the ‘experts’ have your back.

You might, horror, of horrors, have to debate the science itself.

Press Release

Date: 5 December 2024

The Mail on Sunday apologises and pays substantial damages to doctor and academic in “statins” case

Dr Zoë Harcombe PhD and Dr Malcolm Kendrick have secured a full apology, substantial damages and their legal costs from the publisher of The Mail on Sunday, as their long-running libel claims come to a successful conclusion.

The case related to articles published in March 2019, containing allegations that Dr Harcombe and Dr Kendrick had made knowingly false statements about the cholesterol-lowering drug, statins; and that they had thereby caused large numbers of people not to take statins, causing harm to public health.

A statement in open Court, read today on behalf of the Claimants, recorded that these allegations were and are completely untrue, as The Mail on Sunday has now acknowledged. Dominic Garner of Carter-Ruck told the Court that in particular, “neither Dr Harcombe nor Dr Kendrick is a challenger or a ‘denier’ of scientific fact, or a purveyor of lies about cholesterol or statins”. To the contrary, the Court heard that the two Claimants “have always been passionate believers in evidence-based science and open scientific debate, who defend the principle that impartiality and objectivity are called for in the evaluation of scientific evidence, including in relation to the use and prescription of statins”.

Each of them considers strongly “that the debate about the balance of the benefits and harms of statins remains ‘alive and kicking’”. However, they “do not believe that the Defendants treated them fairly in the articles of which they complained”.

The conclusion of the case, through agreed settlements, follows a landmark judgment delivered in June this year, in which Mr Justice Nicklin dismissed the The Mail on Sunday’s public interest defence. The Judge found among things that The Mail on Sunday’s right-to-reply process had been “hollow and superficial” and that the journalist’s attitude towards Dr Harcombe’s and Dr Kendrick’s responses had been “dismissive”, whereas the journalist’s own experts had been allowed to have “a very significant”, and “undue”, influence over the editorial process and the terms of the articles.

In agreeing now to resolve the claims – more than five years following publication – The Mail on Sunday has withdrawn its articles and published a full apology to the Claimants, accepting that its allegations “are untrue and ought not to have been published” and recording that the publisher is “happy to set the record straight, and apologise to Dr Harcombe and Dr Kendrick for the distress caused”.

The Mail on Sunday has undertaken not to repeat its allegations and agreed to pay the Claimants substantial damages, as well as their legal costs.

Dr Harcombe said of the conclusion of the case:

“I am delighted and relieved that this case has been resolved in our favour. This has been a long and complex case, but one that I felt compelled to bring given the scale – and unfairness – of The Mail on Sunday’s public attack on our integrity.”

Dr Kendrick has said:

“I am very happy, and relieved, to have secured complete vindication for what were unfounded smears on my reputation and professional integrity. The Mail on Sunday’s articles should never have been published. The publisher chose to rely on the views of experts who sit squarely on one side of the statins debate, without even acknowledging that there is a legitimate public debate about the use and efficacy of one of the most widely prescribed drugs. Those who do not hold mainstream views on statins should not have their views rejected out of hand or be wrongly cast as dishonest propagandists, as the Mail on Sunday did here.”

Dr Harcombe and Dr Kendrick were represented by Claire Gill and Dominic Garner of Carter-Ruck and by Adrienne Page KC and Godwin Busuttil of 5RB.

NOTES:

Dr Zoë Harcombe is a professional researcher, writer and public speaker on the subject of diet, health and nutritional science. She is a graduate of the University of Cambridge in economics and mathematics and has a PhD in public health nutrition.

Dr Malcolm Kendrick is a recently retired general practitioner, writer, and lecturer, with a specialist interest in the epidemiology of cardiovascular disease. He has authored books including “The Great Cholesterol Con” (2008), “Doctoring Data” (2015), “A Statin Nation: Damaging Millions in a Brave New Post-Health World” (2018) and “The Clot Thickens: The enduring mystery of heart disease” (2021).

IN THE HIGH COURT OF JUSTICE Claim Nos. QB-2020 000799

QB-2020-000801

KING’S BENCH DIVISION

MEDIA AND COMMUNICATIONS LIST

BETWEEN:-

ZOË HARCOMBE PhD

First Claimant

-and-

ASSOCIATED NEWSPAPERS LIMITED
BARNEY CALMAN

Defendants

AND BETWEEN:-

DR MALCOLM KENDRICK

Second Claimant

-and-

ASSOCIATED NEWSPAPERS LIMITED
BARNEY CALMAN

Defendants

STATEMENT IN OPEN COURT

Solicitor for the Claimants

My Lord/Lady, I appear for the Claimants in this matter, Zoë Harcombe PhD and Dr Malcolm Kendrick.

Dr Harcombe is a professional researcher, writer, and public speaker on diet, health and nutritional science. She is a graduate of the University of Cambridge in economics and mathematics and has a PhD in public health nutrition. Her thesis was titled “An examination of the randomised controlled trial and epidemiological evidence for the introduction of dietary fat recommendations in 1977 and 1983: A systematic review and meta-analysis.”

Dr Kendrick is a general practitioner, writer, and lecturer. As a medical practitioner, he worked in general practice, intermediate care and out of hours for two NHS Trusts in Cheshire, the East Cheshire NHS Trust and the Central Cheshire Integrated Care Partnership (CCICP). As a writer and lecturer, he has a specialist interest in the epidemiology of cardiovascular disease. He has authored books including “The Great Cholesterol Con” (2008), “Doctoring Data” (2015), “A Statin Nation: Damaging Millions in a Brave New Post-Health World” (2018) and “The Clot Thickens: The enduring mystery of heart disease” (2021). He was an original member of the Centre for Evidence Based Medicine at the University of Oxford and of The International Network of Cholesterol Sceptics, the latter comprising scientists, doctors and researchers who share the belief that cholesterol does not cause cardiovascular disease. He has also worked for the European Society of Cardiology and the National Institute for Clinical Excellence.

In the course of their research and publications in their specialist fields, both of the Claimants have, to different degrees, contributed to ongoing public debate concerning the use and efficacy of statins, the cholesterol-lowering drugs widely prescribed for cardiovascular disease.

The First Defendant, Associated Newspapers Limited, is the publisher of The Mail on Sunday, and the operator and publisher of the MailOnline website and associated applications. The Second Defendant, Mr Calman, is the Head of Health for The Mail on Sunday, having formerly been the publication’s Health Editor.

On 3 March 2019, the Defendants published in The Mail on Sunday a series of articles as part of a special report under the headlines “Deadly Propaganda of the Statin Deniers”, “Statin Deniers are putting patients at risk, says Minister”, referring to the then Secretary of State for Health and Social Care, Matt Hancock MP, and “There is a special place in hell for the doctors who claim statins don’t work”. The articles were published in similar form online on the MailOnline website on 2 March 2019, where they remained until June 2024. The articles featured prominent photographs of both Dr Harcombe and Dr Kendrick, who were identified as so-called “statin deniers” who published “fake news” about statins.

Several paragraphs of the articles included reference to remarks given to the Defendants by Mr Hancock, known as “the Hancock Statement”. Other paragraphs referred to a scientific paper produced primarily by researchers working at the London School of Hygiene and Tropical Medicine in the University of London and published in the British

Medical Journal known as “the LSHTM Paper”.

Following substantial pre-action correspondence aimed at resolving the Claimants’ complaint without the need for litigation, the Claimants issued proceedings for libel against the Defendants in February 2020. In answer to the Claimants’ claims, the Defendants relied upon substantive defences of honest opinion; truth; reporting privilege under Section 15 of the Defamation Act 1996 (in respect of the Hancock Statement); reporting privilege under Section 6 of the Defamation Act 2013 (in respect of the LSHTM Paper); and publication on a matter of public interest.

The Claimants’ claims went to trial in July 2023 to determine a series of preliminary issues, including the public interest defence; privilege; meaning; whether the publications contained defamatory statements of fact or of opinion; and if and insofar as opinion, whether Mr Calman had held these opinions. A finding that he did not would invalidate a defence to the claims of honest opinion.

The Court was not asked to determine, nor did it determine, who is “right” in the statin debate.

In a Judgment of 25 June 2024, the Court dismissed the Defendants’ public interest defence in its entirety. The Judgment itself may be found in full on the National Archives and Bailii websites. In relation to the way in which the Defendants had gone about the preparation of the articles, the Court found that there had been a number of significant failings in the Defendants’ approach.

The Court held that Mr Calman was an honest witness who had approached his work honestly, and an allegation of malice against him was dismissed. A key issue for the Court was whether or not Mr Calman reasonably believed that it was in the public interest to publish the articles. In that context the Court assessed Mr Calman’s journalistic approach: “what inquiries were made, what did [Mr Calman] know, what information did he receive, what opportunity did he give to the Claimants to comment and respond to the allegations to be made against them and how ultimately did he present all of this material in his Articles?”

After a detailed analysis of how Mr Calman went about writing his story, the Court concluded amongst other things:

The use made by the Defendants of the Hancock Statement “gave readers a completely misleading impression of what Matt Hancock had said” and “Mr Calman knew that”. This was described as a “serious error” on the Defendants’ part.

The portrayal of a patient “case study” used in the coverage – which referred to a heart attack patient at Hammersmith Hospital in London identified as “Colin” – was “misleading”.

That “in the context of the public interest defence, perhaps the most serious omission of Mr Calman was his treatment of the Claimants’ right-to-reply responses”. The failure to consider the responses and the materials in them properly was said by the Judge to have “rendered the right-to-reply process hollow and superficial”, and the Judge also described Mr Calman’s attitude towards the Claimant’s responses as “dismissive”.

That Mr Calman had allowed the experts who had helped him with his story to have “a very significant”, and “undue”, influence over the editorial process and the terms of the articles.

That “[w]hilst there is an important area for editorial judgment in what is reported in any article, it is not in the public interest for a publisher to misstate (or ignore) the evidence it has available. That remains the case even if the underlying material or evidence is complex.”

Informed by these conclusions, the Court held that although Mr Calman believed that publishing the articles was in the public interest, the Defendants had failed to demonstrate that this belief was, in all the circumstances, reasonable, with the consequence that the Defendants’ public interest defence failed. Dr Harcombe and Dr Kendrick welcome that finding, since each of them believes, and has always believed, that the debate about the balance of the benefits and harms of statins remains “alive and kicking” as Dr Fiona Godlee, a former editor-in-chief of the British Medical Journal, put it^[1], and that accordingly where the press wishes to criticise individuals who hold non-mainstream views on statins the public interest demands that the scientific evidence supporting their views should be properly and fairly scrutinised and presented to their readership, not rejected out of hand. They do not believe that the Defendants treated them fairly in the articles of which they complained.

At trial, the Court found that the articles defamed the Claimants by conveying to readers the defamatory meaning that each of Dr Harcombe and Dr Kendrick had repeatedly made public statements about cholesterol and statins that they knew to be false; that there were strong grounds to suspect that each had made these knowingly false statements motivated

by the hope that they would benefit from doing so either financially or from enhanced status; and the direct effect of the publication of these knowingly false statements by Dr Harcombe and Dr Kendrick was, first, to cause a very large number of people not to take prescribed statin medication; and second, thereby to expose them to a serious risk of a heart attack or stroke causing illness, disability or death; that in consequence, each of Dr Harcombe and Dr Kendrick was rightly to be condemned as a “pernicious liar”, for whom there was “a special place in hell”, whose lies, deadly propaganda, insidious fake news, scare stories, and crackpot conspiracy theories, had recklessly caused a very large number of people to stop taking statins, risking needless deaths and causing harm.

These allegations were, and are, completely untrue. In particular, neither Dr Harcombe nor Dr Kendrick is a challenger or a ‘denier’ of scientific fact, or a purveyor of lies about cholesterol or statins. To the contrary, they have always been passionate believers in evidence-based science and open scientific debate, who defend the principle that impartiality and objectivity are called for in the evaluation of scientific evidence, including in relation to the use and prescription of statins. Accordingly, the articles’ allegations went to the core of the Claimants’ personal and professional reputations, by directly impugning their academic integrity and motivation, and attributing to them a risk of having caused a serious public health scare, on a scale said to have been worse than the infamous MMR vaccine scandal.

In particular, to have such allegations made of a dedicated practising GP, Dr Kendrick, was a particularly serious and unjustified slur.

In fact, neither of the Claimants has knowingly made false statements as alleged by the articles. Indeed, Mr Calman acknowledged in his evidence at trial that he did not intend for the articles to allege dishonesty on the part of Dr Harcombe or Dr Kendrick, nor had he seen anything in his research that would suggest Dr Harcombe and Dr Kendrick were dishonest. It is therefore highly regrettable that articles were published by the Defendants which went so far beyond what they said they had intended in terms of a critique of the Claimants and that this serious error on their part was not recognised by them sooner than it was. The Claimants are appalled that, until they were removed from the MailOnline website in June 2024, these grave libels continued to be published there – in unqualified and unamended form, despite requests by them for qualification and amendment – for more than five years.

Furthermore, there is no evidence linking any published views of Dr Harcombe or Dr Kendrick about statins to a reduction in statin uptake, let alone any evidence linking their published views to illness, disability or death consequential upon a reduction or cessation

of usage of statins. Specifically, the LSHTM Paper, to which the articles referred, did not have as its subject matter anything that Dr Harcombe or Dr Kendrick had said or written, but rather was concerned with a general debate on statins taking place in the mainstream media following publication of two papers in the British Medical Journal in October 2013 which were not authored by either Dr Harcombe or Dr Kendrick. The LSHTM Paper simply should not have been deployed against Dr Harcombe or Dr Kendrick by the Defendants in the way it was; there was no justification for doing so.

Finally, the books that Dr Harcombe has written are about diet, not about cholesterol or statins. She does not blog regularly about cholesterol and statins. She has not – and there were no grounds for alleging, contrary to what was implied in the articles, that she had – profited financially from having a stance on statins. As for Dr Kendrick, while he has written several books, articles, blogs and scientific papers about statins, there were no grounds to allege in his case either that he had profited financially from his stance on statins. At the time he wrote and published the various books, articles and papers about statins, he was working in full time employment as a GP, and that was always his primary concern and almost exclusively his source of income. He has derived only modest income from his books and none at all from his articles, blogs and scientific papers.

In its Judgment, the Court stated that in consequence of its decision on the preliminary issues the Defendants’ pleaded defences of truth and honest opinion could not be maintained in the form in which they had been advanced. The Defendants were afforded an opportunity to amend their Defence to bring it in line with the decisions made on the preliminary issues.

The Defendants did not seek to do so, but instead offered to settle the Claimants’ claims in their entirety on terms which the Claimants accepted. As well as undertaking not to repeat those allegations that the articles were found by the Court to bear, the Defendants have published an apology both online and in the print edition of The Mail on Sunday, which accepted that the allegations are untrue and ought not to have been published. The Defendants have also agreed to pay each of the Claimants very substantial damages, in addition to their legal costs.

On this basis, and on the footing that this statement will be read publicly on their behalf in open court, Dr Harcombe and Dr Kendrick are satisfied that they have secured proper vindication in this matter, and feel they are able finally to draw a line under these proceedings

[1] https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(17)30721-3.pdf

A little more on the trial

120 Replies

When the background information leading up to the libel trial was released to us, there was one trail of e-mails that struck me as very damning. It emerged that Barney Calman was very keen to find case histories where people had stopped taking statins and then suffered a catastrophic event, such as a heart attack or stroke, or dying. This ‘stopping statins and dying’ concept was pretty much central to the articles.

Barney Calman asked a Samantha Brick (no idea who she is) to find case histories. Real life stories are always considered to be very powerful by the mainstream media. Which they are. Barney also told her she could offer people money to people who came forward with tales to tell.

Unfortunately for him, the only two case histories she got hold of were people who had started taking statins, and then died. [I believe the information has been sufficiently anonymised so that no-one can work out who these two people were. Although they are already in the public domain, in the court documents bundle, so I am revealing nothing here that is not already open for scrutiny].

The first case concerns a young woman who was put on a statin. Then died from liver failure. Liver failure is a known, although relatively rare, serious adverse effect of statins¹. The second case is less clear cut, but also seems to point directly to a statin ‘caused’ death. [I have tidied up the e-mails a bit to make them easier to read but I have not changed any of the words used].

From: SAMANTHA BRICK [mailto:[email protected]]

Sent: 25 February 2019 18:29

To: Barney Calman <[email protected]>

Subject: possible statins case studies – both died after stopping them*

External Sender~~

Hi Barney,

These 2 replied to my £500 alert. I can probably reduce them to £200 each if you use them both. They are quite similar though in terms of what happened. I’m not sure if this is what you’re after? 39, married mum of two who lives in North London. She lost her sister 16 months ago.

She says:

My sister was 39 when she was prescribed statins. She was a mum of 4 and worked as a manager of a dairy company. When she was diagnosed with high cholesterol, she was advised to change her diet and exercise. Her Dr also told her to take Fluvastatin. She was reassured that even with her busy lifestyle it would lower her high cholesterol.

She took the tablet as prescribed for six months. She began to vomit a lot and had pain in her chest. On more than one occasion she called an ambulance. Each time she was admitted to hospital she was told there was nothing wrong with her heart.

The vomiting episodes began to increase. She was eventually diagnosed with a fatty liver. She stopped taking the statins on the doctor’s advice (a month before she died) and went to see her brother who lives in Berlin. There she was admitted to hospital. By now she still struggled to keep food down and was fed via a tube She was in hospital for a fortnight when she suffered a stroke and died.

This was 16 months ago. The whole family were devastated because her demise came out of the blue. She’d never had problems with her liver beforehand.

————————————————————————————————————————-

Lady 30, is married mum of one who lives in London (waiting on a picture of her with her dad).

She says:

My Dad died two years ago after he had stopped taking statins. (just waiting to find out exactly which ones he was taking) He’d had a heart by-pass in 1998 and was prescribed simvastatin afterwards. He’d been taking others since. He’d been taking them for over 16 years without – seemingly – any problems.

During that time, he’d call ambulance because of pain in his chest. But he was discharged each time without issues. He was also diabetic and taking medication for that. Three years ago, he was diagnosed with liver problems. Straightaway he told to stop taking the statins. At the time he was also throwing up and struggling to keep food down.

Mum would try to feed him jelly or mashed potato but he couldn’t keep it down eventually he was admitted to hospital and was fed via a tube.

While he was in hospital the focus was on the issue with his liver (need to confirm what this was –she thinks that they had to drain fluid from it – will know overnight). While the investigations into the liver problems were carried out, Dad had a heart attack and died.

He’d been on the tablets for years – was it stopping them that caused this. Or were they behind everything that snowballed. I’m worried because my mum also takes statins for her health too – she is on avastatin (I assume atorvastatin). They were married for 50 years mum is still grieving.

Samantha Brick

My book: “HeadOver Heels in France” is out now

Twitter: @samanthabrick

Instagram: Sammy brick

Facebook: Sam Brick

*this e-mail should have read. Both died after taking them.

In the first case I think it is clear cut that this young woman died as a direct result of statin induced liver toxicity. The second case is a little more confused, but the history of throwing up and struggling to keep food down is identical to that of the young woman. Loss of appetite, nausea and vomiting are well recognised symptoms of liver failure. It is also known that it can take months, or years, for statins to cause liver failure. [The final ‘event’ in liver failure is often a cardiovascular event].

Unfortunately for him, the case histories Barney Calman received totally contradicted his argument. At this point you would think Barney may have taken stock. He had two case histories, and two deaths, both almost certainly caused by statins. And it gets worse.

It’s not as if he didn’t understand what he was reading. To use his own words. ‘We’ve had two quite dramatic stories of patients who have been taken off statins by their doctors because of developing serious liver problems, and then died.’ So, he can’t claim he didn’t see them Or, that he failed to understand what he was reading.

But the very next day, he took it away and redoubled his efforts.

From: Barney Calman

Sent: Tue, 26 Feb 2019 08:44:40 +0000From: “Barney Calman” To: “Fiona Fox” , “Rory Collins” , “Colin Baigent” , “[email protected]” , “Sever, Peter S” ,

“Liam Smeeth” CC: “Greg Jones” Thread

To: Fiona Fox Rory Collins Colin Baigent [email protected] Sever, Peter S Liam Smeeth

Cc: Greg Jones

Sensitivity: Normal

Dear all, thank you again for all your input into this article so far. I wanted to readdress the issue of finding a case study. One of the key factors in your collective argument is that criticism of statins discourages use amongst high-risk patients, and this is a public health threat.

Since putting calls out we have been inundated by stories of people who have stopped taking statins and felt far healthier (I put this comment in bold). We’ve had two quite dramatic stories of patients who have been taken off statins by their doctors because of developing serious liver problems, and then died. The families themselves both naturally question whether statins caused the problems. What we haven’t had is a single story which backs your thesis (I put this comment in bold) and obviously I’m concerned.

I think it makes us look rather weak to use a very historic story about Clinton [Bill Clinton stopped his statin then had a heart attack]. What I do not want this piece to be is simply another exercise in singing to the choir and I fear without a real-life example, we may be veering towards it all just seeming like scary theories and doctors saying ‘because I said so.’

What has struck me is that the reason Kendrick, Malhotra, Harcombe and their ilk have really struck a chord is because they are great, emotive communicators. What we’re offering is a chance for you all to be that too, and we are planning to devote an unprecedented amount of space to this.

Have any of you heard a real-life example of someone who has suffered a heart attack or stroke because they declined/quit statins because they thought they didn’t really work anyway, or similar? I really want us do everything we can to make this work. Please do ALL let me know asap today your thoughts about how to move forward. BC

_________________

Barney Calman

Health & Lifestyle Content Director

Mail on Sunday

As you can see, in addition to his two incompatible case histories, Barney was also ‘inundated’ with stories about people giving up statins then feeling far better. Concerns, he still had none. He only had eyes on the prize.

And what of glorious professors, such as Professor Peter Sever, who had proven themselves so eager to assist Barney in putting together his libellous articles. Did he feel the slightest nagging doubt at this point. Nope, nothing of the sort. In fact, this is what Professor Peter Sever had to say

From: Sever, Peter S

Sent: Tue, 26 Feb 2019 09:20:05

To: Colin Baigent Barney Calman Fiona Fox Rory Collins [email protected] Liam Smeeth

Cc: Greg Jones

Subject: Re:

Sensitivity: Normal

External Sender~~

I’m afraid I disagree [Professor Baigent had argued against using case histories, as they were not scientific].

We (my bold) are not trying to convince a scientific audience. This is a communication to the public and they are influenced by case reports and anecdotes whether we like it or not. This is precisely why our opponents* are so successful.

If we are to be successful in countering their claims I’m afraid we have to play by their rules. I’m all for scientific integrity as Colin and Rory opine but this doesn’t work when dealing with the public

Look how many scientific reports have countered the Wakefield claims with so little effect. May I remind you that we all use case reports to illustrate optimal treatment strategies when are teaching. Perhaps not a perfect analogy but not far off!

I support Barney’s point and think we should find a case report (or two!)

Barney what is the timeline?

Regards

Peter**

*note the use of the words our opponents. Yes, ‘our’ opponents. This e-mail was sent to Barney Calman, amongst others. So, whose side do you think Barney Calman is seen to be on? I also made the word ‘we’ bold in the text. At one point during the hearing our barrister asked the question, ‘who is, or are, ‘we’ in this case? Yes, you can damn your defence without even realising you are doing so. It is difficult to claim you are writing a personal opinion piece when your collaborators are using terms such as ‘we’ and ‘our’. And they are including you. Whose opinion is it anyway?

**note how friendly they have all become

Of course I knew, or suspected, that discussions like this had been going on in the background. I did not know who all the collaborators were. However, Barney did let me know, on the 1^st of March 2019 that a critical article was going to be published, naming me. I had less than 24 hours to respond. One part of my reply was – as follows.

‘Listen, we all know where this attack is coming from. The CTT* and Professor Rory Collins and Baigent et al. They attacked Aseem Malhotra and Professor Abramson, then the BMJ, for publishing articles by Aseem and Abramson suggesting statins caused adverse effects in around 20% of people. Collins attacks were severe, and the BMJ was require to hold an investigation, in which Collins attacks on these papers were judged to be unfounded.’

*The Cholesterol Treatment Triallists Collaboration in Oxford. Headed by Collins and Baigent, among others.

As it turns out, I was bang on the money. Which was not difficult. These two lash out at anyone, or anything, who dares criticize statins in any way. It was Collins who first came out with the ‘worse than Andrew Wakefield and the MMR scare’ meme. If he wasn’t the first, he sure uses it a lot. Be careful about the language you use, for it can come back to bite you on the backside.

Next time. Let me have a think. So much to choose from. And, oh, by the way. How are things going Rory and Colin? [I have been told that they read my blog – through gritted teeth].

1: https://www.ncbi.nlm.nih.gov/books/NBK548067/#:~:text=(Review%20of%20safety%20of%20statins,and%200.04%25%20with%20placebo).

The legal case – naming a few names

148 Replies

When the Mail on Sunday published their libelous articles about me on March 3^rd, 2019, I was expecting it. I wasn’t expecting them to arrive on that precise date, or in that specific newspaper. But I had been waiting for something very unpleasant to appear, somewhere. Although I have to say that the level of malice was far greater than anticipated.

But it was entirely predictable what the main thrust of any article was going to be.

I, Dr Malcolm Kendrick, with or without other co-conspirators, would be accused of spreading misinformation about cholesterol and statins. This misinformation would have resulted in many thousands of people giving up their medication and suffering heart attacks and strokes as a result. With thousands dying.

The spectre of Andrew Wakefield and the MMR ‘scandal’ would be raised. With the words ‘far worse than’ to be found somewhere.

I make no claim to be Nostradamus 2.0. But I am capable of adding two and two to make four. I had also taken note of many other attacks around the world. Storing away the accusations made, and phrases used. So, I was well aware of what was heading my way. At least some of it. It was simply a matter of time.

Why do these attacks happen?

The hypothesis that a raised cholesterol level causes heart disease [atherosclerotic cardiovascular disease (ASCVD)] is possibly the single most powerful idea in medicine. If not the most powerful. It has long since reached the hallowed status of a ‘fact’. It is also entirely resistant to all contradictory evidence. To quote from the film Inception.

‘What is the most resilient parasite? Bacteria? A virus? An intestinal worm? An idea. Resilient… highly contagious. Once an idea has taken hold of the brain it’s almost impossible to eradicate. An idea that is fully formed – fully understood – that sticks; right in there somewhere.’

The pharmaceutical industry put their weight behind this idea very early on and shoved mightily. They recognised there were vast fortunes to be made in lowering the cholesterol levels of hundreds of millions of people, if not billions…for life. The perfect money-making machine, sorry medicine.

And lo, the search began for drugs capable of doing this. Starting with nicotinic acid, then clofibrate in 1958. The first drug capable of blocking cholesterol synthesis in the liver was Triparanol, introduced in 1959. It was rapidly withdrawn due to horrible adverse effects. Which could have acted as a warning – but didn’t.

However, it wasn’t until statins were first launched in the 1980s that the money really started to flood in. Statins became the most widely prescribed and profitable medications ever. With sales of nearly one trillion dollars. Today, there are several new cholesterol lowering drugs to keep the party going – and the money flowing.

And while there were nasty attacks on anyone who questioned the mighty ‘cholesterol hypothesis’ from early on, it wasn’t until the mid-1980s that they became truly vicious and seemingly coordinated. A strange coincidence… or perhaps not.

In parallel, a massive nutritional market grew. Low fat foods claiming to reduce cholesterol created a modern day trillion-dollar industry today. And if you dare to suggest the idea that low-fat foods do not protect against heart disease, you get much the same treatment. Which can be distilled into the following statements.

‘You are stupid and dangerous and understand nothing about science. You are also a conspiracy theorist, and your actions are killing thousands.’ Message ends.

Of course, you can never engage with anyone over the science itself. The attacks are lobbed over the castle walls, where your enemy sits safely, refusing to engage on the battlefield. ‘Just pour a little more boiling oil on their heads, if you would be so kind? Their criticism is becoming tiresome.’

Why do these attacks happen. Money, mainly.

Who got attacked first?

I think it was John Yudkin – but I know someone will almost certainly correct me on this.

In 1972 Yudkin wrote the book ‘Pure white and deadly’ where he outlined why sugar was a probable cause of heart disease, not fat(s). Even before this he had been subjected to the full boiling oil treatment. As outlined by the Telegraph newspaper in the UK:

‘The British Sugar Bureau put out a press release dismissing Yudkin’s claims as “emotional assertions” and the World Sugar Research Organisation described his book as “science fiction”. When Yudkin sued, it printed a mealy-mouthed retraction, concluding: “Professor Yudkin recognises that we do not agree with [his] views and accepts that we are entitled to express our disagreement.”

Yudkin was “uninvited” to international conferences. Others he organised were cancelled at the last minute, after pressure from sponsors, including, on one occasion, Coca-Cola. When he did contribute, papers he gave attacking sugar were omitted from publications. The British Nutrition Foundation, one of whose sponsors was Tate & Lyle, never invited anyone from Yudkin’s internationally acclaimed department to sit on its committees. Even Queen Elizabeth College reneged on a promise to allow the professor to use its research facilities when he retired in 1970 (to write Pure, White and Deadly). Only after a letter from Yudkin’s solicitor was he offered a small room in a separate building.

“Can you wonder that one sometimes becomes quite despondent about whether it is worthwhile trying to do scientific research in matters of health?” he wrote. “The results may be of great importance in helping people to avoid disease, but you then find they are being misled by propaganda designed to support commercial interests in a way you thought only existed in bad B films.”

And this “propaganda” didn’t just affect Yudkin. By the end of the Seventies, he had been so discredited that few scientists dared publish anything negative about sugar for fear of being similarly attacked. As a result, the low-fat industry, with its products laden with sugar, boomed.’¹

Lesson number one. If you launch a really venomous attack on one scientist, it tends to deter all the others. Can’t think why.

Then we had Dr George Mann. At one time he was the associate director of the Framingham Study. Which remains the single most influential study on cardiovascular disease, ever. But…

But then he realised there was no relationship between dietary fat or ‘cholesteremia’ – as a high blood cholesterol was called at one time – and heart disease. He discovered this by using the conspiratorial activity called…research. He went to Africa to study the Masai. The men ate almost nothing but meat and drank blood and milk… yuk. As for heart disease, there was none.

Following these, and many other contradictory findings, he formed the Veritas society and edited the book ‘Coronary Heart Disease – the Dietary Sense and Nonsense.’ Of which I have one of the few remaining copies. It cost me fifty pounds…fifty pounds, can you believe it. The things I do for science.

At one point George Mann attempted to arrange a meeting of scientists who agreed that the diet-heart/cholesterol hypothesis was bunk. He ran into problems:

‘Many declined because they felt that participation would jeopardize their grants and perks or, sadder still, because they believe their academic positions would be threatened… when he tried to organize a conference he was told. ‘I believe you are right, and that the diet-heart hypothesis is wrong, but I cannot join you, for that would jeopardize my perks and funding.

As he went on to say: ‘Vast profits are made selling products with trumped up, dishonest health claims. Physicians are co-opted by the media and the “detail men” (salesmen) to prescribe worthless diets and dangerous drugs.’

In the book itself, Professor James McCormick stated:

‘Future generations will look back at this present preoccupation with cholesterol with the same mixture of horror and incredulity with which we now regard colonic irrigation, bleeding and purging.’

James McCormick was a GP and professor of community health at Trinity College Dublin. He was especially critical of health promotion and health screening.

As he once wrote. “Health promotion mixes the obvious and widely known with the questionable and unproven.”. Good man. He described himself, and a few colleagues, as ‘abominable no-men.’ A few brave souls who dared to question the inexorable drive to ever greater health promotion and screening.

Most people are unlikely to have heard of Mann, or McCormick, or the few other brave souls who did turn up to the conference – which was held forty years ago. But they are all heroes of mine. Shunned, de-funded and attacked – in no particular order. I know exactly how they feel.

I could give many more examples of those who have been obliterated. And I will, in later articles. But it is not just personal attacks that are used to underpin profitable ideas and keep science at bay. Scientists are paid directly to promote what are, in essence, corporate lies. I have written about this before:

‘Influential research that downplayed the role of sugar in heart disease in the 1960s was paid for by the sugar industry, according to a report released on Monday. With backing from a sugar lobby, scientists promoted dietary fat as the cause of coronary heart disease instead of sugar, according to a historical document review published in JAMA Internal Medicine.

Though the review is nearly 50 years old, it also showcases a decades-long battle by the sugar industry to counter the product’s negative health effects.

The findings come from documents recently found by a researcher at the University of San Francisco, which show that scientists at the Sugar Research Foundation (SRF), known today as the Sugar Association, paid scientists to do a 1967 literature review that overlooked the role of sugar in heart disease.’²

Just in case you think this sort of thing died out years ago, of course it did not. In the Sunday Times of April 23^rd, 2017, this article appeared, entitled ‘Kellogg’s smothers health crisis in sugar – The cereals giant is funding studies that undermine official warnings on obesity.’ Just to choose a few paragraphs.

‘One of the food research organisations funded by Kellogg’s is the International Life Sciences Institute (ILSI). Last year if funded research in the Journal Annals of Internal Medicine that said the advice to cut sugar by Public Health England and other bodies such as the World Health Organisation could not be trusted.

The study, which claimed official guidance to cut sugar was based on “low quality evidence”, stated it had been funded by an ILSI technical committee. Only by searching elsewhere for a list of committee members did it become clear that this comprised 15 food firms, including Kellogg’s, Coca-Cola and Tate and Lyle.

In 2013 Kellogg’s funded British research that concluded “regular consumption of cereals might help children stay slimmer.” The study, published in the Journal Obesity Facts relied on evidence from 14 studies. Seven of those studies were funded by Kellogg’s and five were funded by the cereal company General Mills.’

Just one small area filled with corruption, corruption and yet more corruption. It is a swamp.

Those behind the attacks

When Barney Calman wrote his articles attacking me, Zoe Harcombe and Aseem Malhotra, I wasn’t really bothered about him. I knew he was simply the patsy who had been dressed up in armour, given a shiny new sword to hold, and kicked out of the castle gate to attack us on behalf of his masters.

‘You go get them, you brave seeker of the truth. Hack away. Sever a few limbs. We may enjoy a few more glasses of red wine before joining you. Can’t tell you exactly when my dear boy. But don’t worry, we have your back. Toodlepip.’

Unfortunately for Barney, to mix metaphors, he hadn’t the slightest idea that he had turned up at a gun fight with a knife. He clearly believed this was going to be a one-sided battle where his victims would put up little or no resistance. And if we did fight back, he had the great knights of the castle to back him up if needed. [Rule One, never trust the knights].

Maybe he really thought he had truth and justice on his side. I have no idea what he thought, and I don’t much care. Whatever his motivations, he set out to do as much damage to me/us as he possibly could. His aim was to destroy. He hacked and sliced about him with gay abandon. He clearly believed himself to be invincible, and untouchable.

Unfortunately for him, one good thing about going to court is that all the discussions leading up to the articles have to be revealed to the prosecution. This would expose all the background discussions.

As Barney stated in an e-mail of the 4^th of Feb 2019 to a fellow Mail on Sunday employee:

‘Can you take a look at this – we’re planning a big takedown of statin deniers.’ This comes from the media and communications list.³

‘A big takedown’… It was rather more than that. Virtually every insult known to man was brought to bear. In case you think I am exaggerating about the sheer vitriolic nastiness of what he wrote, here are some sections from the judgement.

These outline what the Judge considered the articles said about us. A distillation of their intent, if you like. This is taken directly from the Judgement itself, words unedited:

‘….the direct effect of the publication of these knowingly false statements by the Claimant(s) was (a) to cause a very large number of people not to take prescribed statin medication; and (b) thereby to expose them to a serious risk of a heart attack or stroke causing illness, disability or death;

..and in consequence, each Claimant was rightly to be condemned as a pernicious liar, for whom there was a special place in hell, whose lies, deadly propaganda, insidious fake news, scare stories, and crackpot conspiracy theories, had recklessly caused a very large number of people, like Colin, for whom the proven benefits of taking statins were demonstrated by indisputable scientific evidence, to stop taking them risking needless deaths and causing harm on a scale that was worse than the infamous MMR vaccine scandal.’

‘…each Claimant had made false public statements, knowing that they were false.’

‘Put shortly, the Articles alleged that the Claimants had a venal* motive for their lies. This was one of the aspects that made them so deserving of contempt, and a “special place in hell”.⁴

Yes, according to the judge, Barney Calman stated that we lied, and that we knew were lying in order to make money – our ‘venal motive’. Our pernicious lies, deadly propaganda, fake news, scare stories and crackpot conspiracy theories caused needless deaths. For which we were fully deserving of contempt and a ‘special place in hell.’ That is the Judge’s summary of the article’s intent. And if you are going to suggest that is not what the articles actually said, you could find yourself in contempt of court.

Well, I don’t know about you. But where I come from that there’s ‘fighting talk.’

So, we fought, for five and a half years. Yes, obviously I wanted to clear my name, but I was also keenly interested in something else. Which was to reveal the ‘experts’ lurking in the background. Those who I believe represent the organ grinders to Barney Calman’s dancing monkey. To mix my metaphors once more.

Fortunately, the Judge ordered that all e-mails and WhatsApp messages, indeed everything, and everyone involved, would be made available to the public – should they ever wish to read such things. Nothing here is confidential. Which means I can publish all three thousand pages, give or take, should I so wish. Praise be.

And lo, the great knights from the castle hove into view. Of course, I already knew who they would be. They included the usual suspects from the University of Oxford. Professor Sir Rory Collins and Professor Colin Baigent were two of the leading lights, baying for our blood.

This is one message that Professor Sir Rory Collins sent to Barney Calman after the articles were published.³

Dear Barney

What a pleasure to see such a hard-hitting evidence-based article on fake news related to statins … and the page 2 article with Matt Hancock’s very direct comments was an unexpected bonus.

Best wishes.

Rory

But, but…but. There was nothing in the articles that could prove to be an ‘unexpected’ bonus for Rory. Because he played a considerable role in editing the articles. Below are a couple e-mails taken from the Court Disclosures. One page among several thousand.

[I intend to publish a great deal more, to make it entirely clear that there were a group of ‘experts’ working hard in the background to destroy us.]

Yes, the great knights were brought together to terminate us, or at least terminate our reputations. And to be fair to them, they did a damned good job. In addition, they all played a significant part in editing the articles. As the Judge commented on this issue:

‘Although they were not able to dictate what Mr Calman included in the Articles, they nevertheless had (and Mr Calman allowed them to have) a very significant (and in my judgment, undue) influence over the editorial process and the terms in which the Articles were ultimately published.’

Where was the money lurking behind this? Well, Professor Sir Rory Collins and Professor Colin Baigent run the Clinical Trial Service Unit in Oxford. Which is, essentially, a contract clinical trial research organization.

It now sits under the banner of Oxford Population Health… in some complicated way, no doubt designed to throw people off the scent. The funding from Industry can be seen here ⁵. Under the heading ‘Independence of Research.’Hollow laugh.

I added up the funding this unit has received over the last nineteen years (although the CTSU has been around longer than that). After checking a few times, the figure I arrived at was £311,549,300.00p [See Appendix]. This is just over three hundred million pounds (~$400m).

Yes, Professor Sir Rory Colin and Professor Colin Baigent of the University of Oxford run an organisation that has received hundreds of millions in sponsorship. The vast bulk of which comes from the pharmaceutical industry, and the vast bulk of that is used to study drugs designed to lower cholesterol.

This, of course, has not had the slightest influence on anything they say or do with regard to statins, other cholesterol lowering agents, or the cholesterol hypothesis. How could anyone possibly think such a thing of the great knights in their mighty Oxfordian Castle. These eminent figures. Sir this, Professor that, Professor the other. The great and the good.

Of course, they are all desperately insistent that industry funding does not, indeed cannot, have the slightest influence on their research, or what they way. After all, no-one working there receives a penny directly from industry. Emphasis on the word, directly.

‘Research at Oxford Population Health is funded in a number of ways. Much of the funding is peer-reviewed*, which involves other experts independently assessing the Department’s planned research. Such support is provided by a number of government institutions and charities, including the Medical Research Council, National Institute for Health and Care Research, Department of Health and Social Care, British Heart Foundation, Cancer Research UK and Wellcome. In addition, funding is obtained from healthcare companies, particularly for large studies of the treatment and prevention of disease. The department’s research is conducted independently of the funding sources**.⁵

*How do you peer-review funding, exactly? What does this mean? It is simply gibberish made up to make all the commercial funding seem above board. This is not just pharmaceutical company money. It is ‘peer-reviewed’ pharmaceutical company money. Who did the peer-review. A bunch of hedge fund managers? Rory Collins’ bank manager?

**So, a pharmaceutical company provides forty million quid to study their drug in heart disease, and Oxford Population Health (OPH) then heads off to use their money to study another drug in cancer research? I don’t think so. And OPH have absolutely no discussions with the company about the study, at all? I have read some utter bollocks in my life. This sits very near the top.

Maybe I should hire someone to go down and find out where Professor Sir Rory Collins lives and how much his house is worth. And spy on him to see who he hangs out with and suchlike. It would only be fair, as this is what the Mail on Sunday did to me.

Here is an e-mail to Barney Calman from Mark Wood. Barney had asked Wood to find out details about me. Where I lived, how much my house was worth, where I got my income from. I include part of the -email here. [I blanked out my address, as I think that is getting a little close to home, so to speak].

—————————————————————————————————————————–

From: mark wood

Sent: Wed, 13 Feb 2019 18:55:43

To: [email protected]

Subject: statin deniers

Sensitivity: Normal

Hi Barney

Below are some details on your three statin deniers which I’ve been able to collate so far. Got home addresses for all three, and Company House records on any directorships they have or have previously held.

I appreciate the thrust of this is to try and discover how they are benefitting financially from their anti-statin stance…

Dr Malcolm Kendrick

DoB: 17/09/1958 (Age 60)

On his blog describes himself as ‘a GP living in Macclesfield, having graduated from Aberdeen medical school many moons ago.’

He lives in executive detached house at

Property Location:

XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

Property Description:

Detached

Council Tax Band: G

Average Property Value:

£ 733,709

Socio – Demographic Code:

Business Class – Alpha Territory

Property Sale Date:

27/09/1996

Property Sale Price:

£ 217,000

Author of: The Great Cholesterol Con…etc. [There is more].

——————————————————————————————————————————-

No doubt what they really wanted a picture of me lolling about in my luxury apartment in St Tropez, quaffing champagne and laughing uproariously in the company of Andrew Wakefield, whilst lighting a cigar with a fifty-pound note. I wish.

My wife calculated that, given the hours I spent working in my study on research and writing, I have earned about £5/hour from book sales, and the occasional lecture. I think that may be overly optimistic.

Next. A roll call of previous attacks on the ‘statin deniers.’ Then, what should we do about the ever-increasing corruption of medical research? Pitchforks at the ready. Burning torches will be provided to all those who turn up.

1: http://www.telegraph.co.uk/lifestyle/wellbeing/diet/10634081/John-Yudkin-the-man-who-tried-to-warn-us-about-sugar.html

2: https://www.theguardian.com/society/2016/sep/12/sugar-industry-paid-research-heart-disease-jama-report

3: KINGS BENCH DIVISION IN THE HIGH COURT Claim Nos. QB-2020-000799 QB-2020-000801

4: Neutral Citation Number: [2024] EWHC 1523 (KB) Case No: QB-2020-000799 QB-2020-000801

5: https://www.ndph.ox.ac.uk/about/independence-of-research

APPENDIX ONE – FUNDING

Received by the Nuffield Department of Population Health, University of Oxford, since 2005

ACE trial of acarbose (2008-2017)

Bayer: £135K *

ASCEND trial of aspirin and fish oils (2004-2017)

Abbott/Solvay/Mylan: £2.1M plus drug supply Bayer: £1.8M plus drug supply

ASCEND PLUS (2021 – ongoing)

Novo Nordisk A/S: £39.4M

Assessing the potential for SenseCam to fight the current global health crises of increasing obesity and physical inactivity (2010-2013)

Microsoft: £69K

ATLAS trial of tamoxifen duration (1997-2018)

AstraZeneca: £1.0M plus drug supply

BEST-D pilot trial of vitamin D (2012-2014)

Tishcon: free drug supply only

Big Data Institute (2018-2021)

Novartis Pharma AG Switzerland: £272K

Can wearables improve the prediction of all-cause mortality, cardiovascular disease, and cancer in UK Biobank? (2022-25)

Swiss Reinsurance Company: £645K

China Kadoorie Biobank (2002-ongoing)

AstraZeneca: $300K

Bayer AG: £300K

GlaxoSmithKline: £3.6M

Merck: £200K

Novo Nordisk A/S: £341k

Development of digital biomarkers for dementia (2016-2022)

Eli Lilly and Company USA: £600K

Development of digital biomarkers for dementia (2016-2022)

Roche: £600K

Diabetic Peripheral Neuropathy Treatment with Dorsal Root Ganglion Stimulation a Randomised Controlled Trial (2018-2020)

St Jude Medical Europe Inc: £52K

Doctor Referral of Overweight People to Low Energy Treatments (2015-2020)

Cambridge Weight Plan Ltd: £35K

DYNAMIC CONSENT USCF (2015-17)

Oxford University Innovation Ltd: £28K

Economic burden of malignant neoplasms in the EU (2011-2012)

Pfizer: £36.5K

Elinogrel feasibility trial (2010-2011)

Novartis: £500K

EMPA-KIDNEY (2017-ongoing)

Boehringer Ingelheim: £106.3M

Establishing Fuwai-Oxford research centre (2010-ongoing)

Merck: £1.1M

Estimating acceptable non-inferiority margins for antibiotic stewardship interventions using discrete choice experiments (2021-2023)

Mars Petcare UK: £25k

EXSCEL trial of exenatide (2009-2017)

Amylin: £473K *

FOXFIRE trial of chemotherapy with or without radioembolisation for bowel cancer that has spread to the liver (2009-2017)

Sirtex: £228K *

Genomic Data Working Group (2020-2025)

Regeneron Pharmaceuticals Inc: £107K

Heart Protection Study follow-up studies (2003-2010)

Merck: £1.2M

GlaxoSmithKline: $400K

Liposcience: £50K

HPS2-THRIVE trial of niacin/laropiprant (2005-2015)

Merck: £53M plus drug supply

HPS3/TIMI55-REVEAL trial of anacetrapib (2010-2022)

Merck: £108M plus drug supply

HPS 4/TIMI 65 – ORION-4 (2017-ongoing)

Novartis Pharma AG Switzerland: £73.7M

HPS 5/ORION-17 (2020-ongoing)

Novartis Pharma AG Switzerland: £1M

Integration of medical imaging and genetic data using machine learning for identification of micro and macro vascular disease targets (2021 – ongoing)

Novo Nordisk A/S: £1.2M

Large-scale multi-omics assays in China Kadoorie Biobank (2020 – 2023)

Bayer AG: £1.58M

LENS trial in Non-proliferative retinopathy in Scotland (2016-2022)

Mylan: free drug supply only

MaatHRI Project (Ultromics) (2018-2022)

Ultromics Limited: £79K

Measuring sleep characteristics using machine learning in wearable datasets (2020-2023)

Novo Nordisk A/S: £135K

Mexico City Prospective Study (2021 – ongoing)

AstraZeneca UK Ltd: £1.81M

Regeneron Pharmaceuticals Inc: £1.78M

NAVIGATOR trial health economics analysis (2013-2014)

Novartis: £15K *

Next generation sequencing analysis – a clinical study (2011-2014)

Life Technologies: £125K *

Non-invasive rapid assessment of liver disease using magnetic resonance (2016-2019)

Perspectum Diagnostics: £273K *

Novo-Nordisk Postdoctoral Fellowship Programme (2021-2023)

Novo Nordisk A/S: £221.3K

Observational study of a multi-cancer early detection test (2021-2023)

Grail Bio UK Ltd: £101k

Oxford-Janssen Human Genomics Fellowship Programme (2020 – ongoing)

Janssen Biotech: 1.22M

Oxford Participation & Activities Questionnaire (Ox-PAQ) Phase 2 Study (2014-2017)

Actelion: £58K

OxPod (2021-27)

Podium Analytics: £75K

Pandemic Science Institute Investigator Allowance (2022-23)

AstraZeneca UK Ltd £5k

Pharmacogenomic analysis of the Heart Protection Study using a CAD polygenic risk score (2020 – 2025)

Regeneron Pharmaceuticals Inc: £143K

PROCARDIS genetic study (1998-2011)

AstraZeneca: £1.7M

SEARCH trial of simvastatin dose (1997-2010)

Merck: £22.7M plus drug supply

SHARP trial of simvasatin/ezetimibe (2002-2013)

Merck/Schering: £40M plus drug supply

SHARP3 (2022-23)

Boehringer Ingelheim: £1.8M

Small open reading frames in drug discovery: from genetics to mechanisms to new therapies (2022-24)

Novo Nordisk A/S: £49K

STICS trial of rosuvastatin (2011-2014)

AstraZeneca: $100K

TECOS Trial Evaluating Cardiovascular Outcomes with Sitagliptin (2008–2022)

Merck & Co Inc: £140k *

Therapies for Influenza (2019-23)

Oxon Epidemiology Limited: £77K

The Transthyretin (ATTR) Amyloidosis Questionnaire (ATTRAQ) (2020-2022)

Pfizer: £147K

Thrombotic Microangiopathy associated Pregnancy Acute Kidney Injury in the United Kingdom: Incidence, Outcomes and Risk Factors (2021 – 2022)

Alexion Pharmaceuticals Inc: £32K

UK-HARP-III pilot study of LCZ696 (2013–2018)

Novartis: £2.6M

Using data from wearable devices to identify novel targets for cardiometabolic disease (obesity, T2DM, NAFLD, & heart failure) (2021 – 2024)

Novo Nordisk A/S: 1.25M

Using Whole Genome Sequencing Datasets to Identify Novel Disease Genes and Mechanisms (2020 – 2022)

GlaxoSmithKline Research & Development £359K

3-C trial of transplant rejection (2009-2017)

Pfizer: £530K

Novartis: £350K

* Funds received by the department’s Health Economics Research Centre for trials led by other Oxford University departments or Institutions.

A Win

209 Replies

21st October 2024

Finally, the dust settles. Zoë and I won our case against the Mail on Sunday. The judgement came out a few weeks ago, but the legal wrangling continued – and still continues. The Mail on Sunday did print an apology. Legally, they do not have to print an apology, but they did, which says something.

There is still a statement in open court to come (SIOC). What is a statement in open court?

‘A statement in open court on settlement of action is an important mechanism for vindication for the claimant in, inter alia, libel proceedings and also for the correction of false and/or defamatory statements.’¹

It is a much longer thing, which lays out in more detail, what was wrong with the article, and may contain sections such as:

‘Mr Calman allowed the experts who had helped him to have “a very significant”, and “undue”, influence over the editorial process and the terms of the article. ‘

The SIOC has to be agreed by the judge, and this has not yet happened. Boy, do these things take ages. I have been sitting on my hands for months. I still am.

But some names are going to be named. We know who you are. The behind the scenes activity was quite outrageous. Eventually, all will be revealed. Because none of this is confidential anymore. The rock was lifted to see the creatures squirming in unaccustomed sunlight.

Revenge is a dish best eaten cold.

1 https://www.lexisnexis.co.uk/legal/glossary/statement-in-open-court#:~:text=A%20party%20can%20apply%20for,accompany%20the%20notice%20of%20application.

A little more on the trial

100 Replies

11th July 2024

As regular readers will know, Zoë Harcombe and I sued the Mail on Sunday (Associated Newspapers) and Barney Calman for libel. This is a saga that began over five years ago. Which has explained much of my recent silence on this blog, following a hearing in July last year.

We won on almost all points. Some of them very technical. The entire judgment can be seen here https://www.bailii.org/ew/cases/EWHC/KB/2024/1523.pdf

Here is one part, section 509

“Before turning to the remaining issues, I should repeat that the exercise of determining the objective single natural and ordinary meaning of the Articles, and whether the Articles are or contain allegations of fact and/or expressions of opinion is wholly different and distinct from the assessment of Mr Calman’s subjective assessment of the meanings that the Articles bore (see [247] above). I have necessarily had to deal with many issues, in great detail, in the earlier part of this judgment. I put all of that to one side. Save for necessarily identifying those passages of the Articles that I have found to be privileged (or are agreed by the parties to be privilege) for the purposes of Curistan, the resolution of these other issues has no bearing on the objective assessment of the natural and ordinary meaning of the Articles and fact/opinion. In that respect, my task in the next part of the judgment is to apply the well-established principles as set out in G(5) ([380]-[387] above).”

Much of the judgement is rather similar. So, unless you suffer from insomnia, I would not recommend it as a cracking read. However, there are some gems to be found.

You may ask, and many have, why did you go ahead with this case. It was risky, costly, and you might lose. And, in the end, it will pass. People will forget it was ever written. Today’s news is tomorrow’s fish and chip supper wrapping.

Well, maybe. I think Judge Nicklin summed up what he felt were the main messages in the articles we complained about. This passage. Paragraph 254.

‘…the presentation of these articles, as a whole, reinforced this message. The “devastating investigation” exposed the “fake news” by “unequivocal science”. The “‘fake claims’ about proven medicines”, amounted to “deadly propaganda”, a “wanton spread of medical misinformation”, and a “vastly overstated” case by the “statin deniers”. The science showed that “none of which is right” and was contradicted by “researchers who have devoted their lives to understanding how to treat heart disease” and who had produced “the highest quality scientific evidence on the subject”. The “pernicious lies” of the ‘statin deniers’ “needlessly risked lives”, and damage to public health, that was “worse than the MMR scare”.

Essentially, in his finding about meaning [para 516], Judge Nicklin basically made clear we were accused of being pernicious liars spreading deadly propaganda – suspected to be for our own venal reasons. We had, potentially, killed many thousands. Someone did say to me ‘At least you weren’t accused of being a paedophile.’ This did not go down well with me.

‘So, killing thousands is better than being a paedophile, really?’

I consider that to be blamed for killing thousands is the worst possible accusation you can make against anyone, especially a doctor. Not only that, but the articles directly implied we were only doing this– in order to make money. Does it get worse. Can it possibly be worse?

Well, it could have been worse in that I could have been struck off, and not allowed to practise medicine ever again. After all, if what I did was ‘worse’ than the MMR scare, and we all know what happened to Andrew Wakefield who was struck off and can no longer work as a doctor. I have been waiting for the letter from the General Medical Council to drop through my letterbox for over five years now. So far, nothing.

In essence I could not possibly let this go, and nor could Zoë.

Where are we now? The initial judgement has been made, but the defendants (Associated Newspapers and Barney Calman) have indicated they intend to seek permission to appeal. And the appeals process can go on, and on. Ending up at an appeals court. Will the appeal be successful. I have no idea. Will they give in and accept the judgement. I hope so. I hope others can understand that if you are accused of killing thousands, simply in order to make money for yourself, then you really have to take a stand. If not, what?

We have a judgment (Part 1)

172 Replies

25 June 2024

In the case against the Mail on Sunday (Associated Newspapers) and Barney Calman, Health Editor of the Mail on Sunday.

I have written nothing on this blog for a while, because of my on-going legal case. Now we have a judgment, part one.

Step backwards for a moment. Zoë Harcombe and I are suing the Mail on Sunday and Barney Calman for libel. This goes way back to March 2019, yes over five years. The Mail on Sunday published article(s) that we felt were very damaging and defamatory.

In short, we were effectively accused of being liars, and ‘purveyors of misinformation’ about statins (drugs that lower LDL/cholesterol). Because of our lies hundreds of thousands of people had stopped taking statins, resulting in (potentially) many thousands of heart attacks, strokes and deaths. Which, as a doctor, is the worst ‘crime’ it is possible to be accused of.

There was much discussion, in the articles, of this being far worse that the MMR scandal involving Andrew Wakefield. You may remember that he was stuck off as a doctor for his papers and articles on the MMR vaccine. This could obviously have happened to me. If what I did was worse. This threat has hung over me for over five years.

In his judgment I think that the following statement was the most powerful

There is perhaps a palpable irony in the fact the Defendants, in Articles that so roundly denounced those alleged to be the purveyors of misinformation, so seriously misinformed their own readers

The Judge has basically ruled that the Mail on Sunday misinformed its own readers. And as he also said.

I have found that Mr Calman did not believe that the Claimants were dishonest, yet this is the core allegation that the Articles made against them, as Mr Calman must have known (or a reasonable journalist in his position would inevitably have realised).

We were not dishonest, yet Barney Calman wrote articles where the core allegation is that we were. I will write more on this issue over the next few weeks and months. The legal issues were ridiculously complicated and so I include my lawyers’ statement below, which explains a bit more as well as a link to the judgment itself. The full judgment – all 255 pages of it – can be seen here.

High Court dismisses Mail on Sunday’s public interest defence in “statin deniers” libel case

In a major Judgment delivered on 25 June 2024, Mr Justice Nicklin has dismissed a public interest defence advanced by The Mail on Sunday in a libel claim brought by Dr Zoë Harcombe and Dr Malcolm Kendrick. The decision follows a preliminary trial last year in what the Judge described as “the most significant piece of defamation litigation” that he had seen in a very long time.

The case relates to articles published in March 2019, which contained allegations that the Claimants had made knowingly false statements about the cholesterol-lowering drug, statins, causing a large number of people not to take prescribed statin medication with the harm to public health that flows from this (allegations which Dr Harcombe and Dr Kendrick assert are both highly defamatory and false). The Mail on Sunday refused to apologise or even remove or alter its articles. The Claimants therefore issued High Court proceedings in February 2020.

Dismissing the newspaper’s public interest defence, the Judge observed (at paragraph [457]) of his judgment) that:

“There is perhaps a palpable irony in the fact the Defendants, in Articles that so roundly denounced those alleged to be the purveyors of misinformation, so seriously misinformed their own readers.”

The case will now move on to its next phase, as the Court was not at this stage adjudicating on other aspects of the case such as the Truth defence which the Mail on Sunday is attempting to put forward, albeit the Court’s findings mean that the Defence as currently formulated, and subject to any appeal, “cannot be maintained” [562].

Dr Harcombe PhD, a writer and speaker on diet health and nutritional science, has said of the judgment:

“I am delighted by the findings of the court today, in what is a hugely complex case. I am grateful to the Judge for his detailed and careful analysis of all of the facts and pleased that he has recognised the enormity and unfairness of the public attack on our integrity.”

Dr Kendrick, a General Practitioner and author with a special interest in the epidemiology of cardiovascular disease, said:

“I am very pleased that the Judge has found in our favour, and that he has dismissed the public interest defence. It was always our position that we had not been treated fairly by the publishers, and the Judgment sets out clearly how badly we were in fact treated.”

Dr Harcombe and Dr Kendrick are represented by Claire Gill and Dominic Garner of Carter-Ruck, and by Adrienne Page KC and Godwin Busuttil of 5RB.
Links

Read the full judgment here.
Read the summary of the judgment here.

What’s wrong with the NHS? – part five

118 Replies

29th December 2023

The underlying forces

In the last few blogs, I have been writing about the proliferation of guidelines, targets, and regulatory work in the NHS. Hopefully I have managed to give you a sense of how much time and effort these pile on to everyday work. Time and effort which eats away at clinical time, erodes morale and drives down productivity.

None of this is unique to the NHS. It is not unique to healthcare, and it is certainly not unique to the UK. An ever-tightening regulatory framework is affecting almost everyone, worldwide. ‘Ratchet world’ as I call it.

However, I believe that healthcare, specifically the NHS, represents the highest regulatory pinnacle. The Mount Everest in the target and regulation world. This is because it is driven by three different, but interconnected forces:

The risks attributed to medico-legal/patient harm.
Complexity – and the desire to micromanage.
The size of the organisation.

Medico-legal pressure to record absolutely … everything

In this blog I am only going to start looking at the first of these forces. Medico-legal/patient harm. Even here I can barely scratch the surface.

‘The provision for claims against the NHS increased from £85.2 billion ($108 Bn) to £128.6 billion ($163Bn) n March 2022.’ ¹

More and more people are suing the NHS for damages. More and more people are complaining about their treatment, whether or not they go on to sue.

Is care getting worse, or does this represent a rise in complaint culture? ‘No-win no-fee’ lawyers are certainly advertising harder than ever. And if you think your care went wrong, why not sue? There’s nothing to lose, and you could end up several thousand pounds richer. Maybe far more.

Whatever the underlying reasons, complaints clog up the machine, directly and indirectly. Even if they are not ‘successful’, they take up vast amounts of time to resolve. Not that long ago I received a nasty complaint about my poor care for a patient. I was on holiday at the time and could easily prove it.

I still had to spend many, many hours dealing with it. So did my manager, and the complaints team at the hospital. And the unit manager and …One phone call by the General Medical Council was all that was needed. ‘Yes, he was on holiday all week.’

Leaving that to one side. The issue I want to look at here is the downstream, or indirect impact, that the threat of litigation creates. The moment any complaint arrives, management circle the wagons, then pore through the patient’s notes to check that all guidelines and regulations were followed – to the letter.

Was the falls audit done? Were all the Water Lows done? Were all care indicators filled in. Below is an example of a ‘Water Low’ chart. It has to be completed within six hours of admission, repeated if there is any change in the clinical condition, and done at least weekly otherwise, in some cases up to three times a week. God help you if it is missing.

And, no, I don’t know why it is called Water Low. I think it should actually be Waterlow.

There can’t be any gaps in ‘excellent’ patient care. All cups of tea offered, and drunk, with the correct number of sugars stirred clockwise. Everything will be scrutinised. The mantra here, as always, is that: ‘if it isn’t written down, it wasn’t done.’

Recording everything, no matter how unimportant, is how lawyers believe a perfect world should be ordered. Their view is that you cannot possibly defend yourself by saying. ‘Of course I did that, it’s what all doctors do. What we are trained to do. Now, you need to prove I didn’t. I shouldn’t need to prove I’m innocent, you need to prove I’m guilty’… Jurisprudence page one, paragraph one. In England least. [Scots law is subtly different]

When I started out in GP-land, all consultations were written out by hand, and we had seven minutes per appointment. Which included the patient’s agonisingly slow walk along the corridor, trying three wrong doors along the way, taking a history, the examination, making a diagnosis, and writing notes. Then, finishing with a prescription. Along with any friendly chat.

If someone had a cough, and possible chest infection, the entire consultation could be written up as. LRTI. Rx Amoxicillin 500mg TDS. Review 1/52 if symptoms no better. MK. 12/6/1993

[Translation: Lower respiratory tract infection. I prescribed amoxicillin 500mg three times daily. I advised the patient to come back in a week if symptoms were no better. My initials and date at the end].

This would now be considered indefensible medical practice. Why did I fail to record the respiratory rate, the oxygen levels, the blood pressure, what did I hear in the chest? Were there signs of possible sepsis, and on and on and on.

You know, if there had been anything important to find, I would have written it down. And if I believed the patient was ‘proper’ ill, I would have sent them to hospital. Or asked them to come back in the next day to make sure they were not getting worse. But no, not now. All shall be written down.

Inexorably, we have ended up with endless drivel in the notes, from all and sundry. ‘I went into the room and introduced myself as George, a physiotherapist. I checked how the patient would like to be identified. They said their name was Mabel, but they like to be called Iris. They consented to my examination ….’ And on, and on. Names changed for patient confidentiality.

In my view anyone writing nonsense like this inpatient notes should be taken to one side and told, in no uncertain terms, to stop writing this bilge … right now, immediately, and never do it again.

It is a complete and utter waste of everyone’s time. It is not clinically relevant in any way. It also makes it almost impossible to find anything that might be important buried in there somewhere. Such as, what you thought was wrong with the patient, what you actually did, and what happens next, and anything you would like me to do …George.

However, management absolutely love this exponential expansion in record keeping. Indeed, they want more, and more … and more. When a complaint comes in, they can point to this endless verbiage.

The chest was examined for fifteen minutes, all negative findings meticulously recorded. Nothing was actually found anywhere else, meticulously recorded. Although they complained of a headache, I spent ten minutes examining their abdomen, all recorded.

I do not want to know what is ‘not’ wrong with the patient. I want to know what is wrong with the patient. This nonsense comes to a head with NHS 111. This is the service that patients can call, outside of GP surgery opening times. If they are unwell, but do not need an ambulance.

NHS 111 staff record everything, every breath taken. They are especially keen on capturing information about what the patient does not have wrong with them. The patient had not suffered a head injury, the patient was not pregnant, and on, and on.

Their reports now run to nineteen pages, with a great deal of information about what the patient did not have. Sitting on the receiving end, I do not even bother to read them. Because it is almost impossible to find out why the patient called in the first place.

It will be in there somewhere. But it should be page one, line one. ‘The patient called the service because they had a bad headache.’ This may be buried on page five. After two pages recording when the patient called, who took the call, when it ended, what phone numbers were used. What service the patient was referred to, by whom, when. Sigh. Followed by another two pages of conditions that the patient does not have. The patient was NOT hit by an asteroid.

When the patient arrives in my room, having been directed to see a doctor by NHS111, I just ask. ‘What seems to be the problem today?’ They always look aghast. ‘But I have already told NHS 111 all this.’ Yes, but there is not the time in the day for me to read such endless, pointless, garbage… I think this, but do not say it. I just smile in a kind and reassuring way. Whilst snapping a pencil in two under the desk.

The function of medical records is not for them to be written in such a way that they can be used to defend against litigation. It is to pass clinically important information between medical professionals, to enable them to do their job better. Therefore, it must be brief – and to the point.

Try saying that to a manager in the NHS. It is a concept so alien to them, that they almost certainly cannot understand what you just said. Blink! Hard disk reset.

I was recently told that I should write something in the patient notes, every day. Such as what? ‘Clinically, the patient is exactly the same today as they were yesterday. So I didn’t examine them, or prescribe anything.’’ What of patients attending hospital out-patients for a review when I go to see them? ‘The patient was not in the unit today, so I do not know if they are clinically unchanged since yesterday.’

Is that the type of thing you’re looking for?

Yes, was the answer.

Can we row this back?

Perhaps we could start with Winston Churchill who, as always, puts it best.

Churchill knew, as we all know, that pages of meaningless guff serve only to block effective communication. For example, the notes that arrive with patients from the local hospital are, still, written out by hand. It is literally impossible to gain any useful information.

If I do manage to raise the enthusiasm to read them, I find that I often have no idea why the patient was admitted, what happened to them, or why. But, by crikey, you need to go the gym regularly to lift them.

Brevity is what we need. But endless recording, of everything, is what we get. Along with a massive increase in the ‘everything else’ that simply must be done. It is a great burden to carry. It gets heavier every day. It is driven by a number of forces, but the strongest driver is litigation, and the threat of future litigation.

My estimate, plucked from thin air, is that ninety per cent of what is written down is never read by anyone, ever again … ever. The only time anyone shows any interest is if there is a complaint. Then, the interest becomes obsessive, and the management demand that ‘everything’ must be recorded grows.

My other estimate is that medical staff now spend far more time writing, than doing. ‘Doing’ meaning clinical work. Looking after patients – perish the very thought. I have idly tried to work out how much time the physios in our unit spend writing vs. doing. I think it is currently around 80:20.

And what do patients and relatives complain about most? It is almost always that no-one had any time to look after them or pay attention to their needs. I have yet to hear of anyone complaining that medical staff did not spend enough time writing in their notes.

My prediction would be that, if we spent more time doing, and less time writing, there would be far fewer complaints. Because more care could be provided, the patients and relatives would be happier, and so would the staff. Improving morale, and thus patient interaction.

However, this will not happen until we decide to turn the burden of proof round though one hundred and eighty degrees. As I may have mentioned a few times, the current mantra is that ‘if it is not written down, it was not done.’

My counter-mantra would be. ‘We are highly trained professionals, you (Mr Lawyer) need to prove that we did not do our job, properly.’

This does not mean that you can get away without recording anything at all. Clinical notes are still needed. But they need to be clinical notes that are of use to fellow clinicians, not lawyers.

NHS 111 reports should be a few lines max. ‘Mr X has had a cough for three weeks. He reports that is bringing up green sputum, he recorded his temperature at 38.5⁰C. Chest feels tight. No other relevant symptoms. Past medical history of asthma and COPD. Has not yet seen a GP.’’ The end. I need no more than this.

Imagine such a thing. A note that Winston Churchill might have approved of:

‘The discipline of setting out the real points concisely will prove an aid to clearer thinking.’ 1: https://resolution.nhs.uk/2022/07/20/nhs-resolution-continues-to-drive-down-litigation-annual-report-and-accounts-published-for-2021-22/#:~:text=The%20amount%20spent%20on%20claims,billion%20to%20%C2%A3128.6%20billion.

Very high LDL no impact on plaque progression

159 Replies

10th December 2023

A very important study – please watch

Very high low density lipoprotein levels with no impact on plaque progression

I interrupt my series on what is wrong with the health service to bring you breaking news. I was sent the e-mail below, directing me to a short YouTube presentation by Dr Shawn Baker.

It highlights a study which provides very strong evidence that a very high LDL (as seen in some people who go on a keto diet), has no impact on coronary artery plaque progression.

It was sent to me by Brian Fullerton MD, for which I shall be eternally grateful. E-mail below. I have edited the e-mail somewhat, but there is no change in meaning.

‘Transcript (ish) from video:-

“Professor Matt Budoff MD at UCLA recently presented a collection of data soon be published in the journal Metabolism. Abstract to be published shortly. What he looked at was a collection of people on very low carb ketogenic diets who also happened to have extremely high LDL cholesterol. As high as 600 milligrams per decilitre (15.5mmol/l).

They did a coronary CT angiogram study looking at the coronary vessels in the heart to find out how much plaque/calcium was in their arteries, and compared this to age matched controls, who were essentially, identical, in every other way.

Their body mass index was the same, as were ages. Average age was close to fifty-five in both groups. They were all healthy with none of them having diabetes, or hypertension, meaning that they were well matched.

The one major difference being that one group had high LDL cholesterol, and the other had “normal” LDL cholesterol. In those with the very high cholesterol it had been at that level for at least five years.

Matthew Budoff the principal investigator is arguably the world’s leading authority on how rapidly you can detect plaque accumulation in the coronary vessels over time. He states that five years is more than sufficient to detect any difference in plaque progression.

The prediction was that the group with the highest LDL-cholesterol levels should have considerably more plaques and/or calcification in their arteries.

They did not find any statistically significant difference between the two groups. So, it did not appear to matter if you had ‘super high LDL’ or ‘normal” LDL cholesterol. In fact, the trend was that the people with the high cholesterol had less plaque in their arteries.”

The presentation can be seen below:

What’s wrong with the NHS? – Part 4

61 Replies

8th December 2023

Nothing can simply be ‘good enough’. Before beginning this blog, I thought I would introduce you to the first two laws of regulation ‘regulation-omics’:

I know that many of the things that are obliterating productivity in the NHS are happening in all health care services, everywhere. A couple of blogs back I mentioned a US study which looked at all the guidelines primary care practitioners (PCPs) are now required to follow. If they were to do all the work required, it would take them twenty-seven hours a day.

So, clearly, they don’t.

Which raises a few interesting questions that I shall just let hang there at present. For example, what are these PCPs doing? Making stuff up? Hoping no-one notices? As for those creating these endless guidelines. Does it bother them that the vast majority are being quietly ignored?

Or do they simply announce. ‘Hear ye, hear ye, hear ye. The mighty guidelines hast been written; our work is done. Now, make it so.’ Snapping of fingers, courtiers shuffle off, heads bowed, hidden and exasperated eyebrows raised.

Very recently a conference for GPs in England debated a motion. One that was easily passed. It was reported in Pulse magazine – a weekly magazine for GPs – as: ‘NICE ‘out of touch with reality of General Practice, say GP leaders.’ The motion was:

‘That conference applauds the aspiration for clinical excellence across the NHS but believes:

(i) that NICE guidance is often out of touch with the reality of working in general practice

(ii) in the current climate practitioners should be judged against ‘good enough’ rather than unrealistic ‘gold standards’

(iii) that the GMC and NHS Performance teams should not be judging practitioner performance against NICE guidelines

(iv) that GPC England should lobby for professional and clinical standards to be aligned to current workforce and workload capacity.’¹

As Voltaire once said. ‘The excellent is the enemy of the good.’

Good enough is no longer… good enough. In the NHS it is now demanded of everyone that all workers should constantly strive for excellence. Woe betide anyone who dares let their standards fall below perfect excellent-ness.

This is where all those one hundred and twenty-six organizations [one hundred and twenty-five, plus NICE] who are involved in regulating the NHS – cause so much pain. Whatever they look at, it requires constant improvement. You must now do this better, and this, and this, and most certainly this. No bed sore shall ever be missed. No patient shall ever fall over. Falls audits shall be completed relentlessly.

All patients shall be asked each and every hour if their every need is being met. At all times all staff shall be attentive, and smiling and helpful and, and, and….and? All guidelines will be met, at all times. All sinews shalt be strained in a constant drive for improvement. To quote Joseph Stalin at the First Conference of Stakhanovites in 1935:

‘These are new people, people of a special type … the Stakhanov movement is a movement of working men and women which sets itself the aim of surpassing the present technical standards, surpassing the existing designed capacities, surpassing the existing production plans and estimates. Surpassing them – because these standards have already become antiquated for our day, for our new people.’

There is nothing wrong in asking people to provide a good, and safe, standard of care. But there comes a breaking point in striving for ‘the excellent’. A point that has long since disappeared in the rear-view mirror.

I have not analysed the time it would take GPs in the UK to meet NICE guidelines, but I strongly suspect it would be far more than twenty-seven hours a day. Here, for example, plucked at random, is a reference to the latest NICE guidelines on the management of hypertension (high blood pressure) in adults. This, the short version document, runs to fifty-two pages.²

Have I read the entire document. No. Has anyone. Possibly. But this, the primary guideline on hypertension for adults, is but one of many. There are associated guidelines on hypertension in pregnancy. In addition, there are links to formal risk assessment in cardiovascular disease. With bonus hyperlinks to NICE’s guidelines on hypertension in chronic kidney disease and type I diabetes and type II diabetes and on and on.

In short, this fifty-two-page document is but the tip of a massive iceberg when it comes to high blood pressure, monitoring, measuring, and treating. Which, in turn, is one very small part of the totality of medical practice. No-one can read all this stuff. No-one can keep up. You sure as hell can’t remember it all. It is, truly, impossible.

So, what do GPs actually do when presented with such demands? Well, at present, many of them are considering RLE. Retire, leave, emigrate. “RLE” is now popular trope in GP discussion fora. This is because the sheer stress and overall unpleasantness of the job has become overwhelming.

There was a time when being a GP was an enjoyable job. No more. Those days are gone my friend. Twenty years ago, a partnership in General Practice attracted hundreds of applications. Today, many adverts result in no applications at all.

If you set people an endless barrage of targets and guidelines that can never be reached, it drains people of any, and all, enthusiasm. Every day at work becomes a day of failure. Rolling that great rock up a slope, only to see it roll straight back down again.

Yet, those who drive this catastrophic system just can’t stop themselves from cascading more and more guidelines, and targets, upon a workforce that long since gave up trying to meet them all.

Not only does this crush morale; it also obliterates productivity. So very many pointless tasks. So much time doing work that has only the most tenuous link to patient care, and benefit. I have focussed on GPs in this blog, but everything I have written is much the same, everywhere. Primary care, secondary care.

I think nurses have it worse than doctors. Indeed, from chatting to them, I know they do. Whilst doctors have still managed to cling onto some small scraps of clinical freedom. By which I mean the ability to manage and treat the patient in the way they think best. Nurses have no such freedoms. Their guidelines, and targets, are cast from hard, unbending iron. You do it, or else. And do not dare deviate.

Why can’t these organisations just, stop? Even better go into reverse. Can they not even attempt to define what is ‘good enough.’ No, we the mighty, have told you what constitutes perfect care for raised blood pressure. So, this is what you must do. Even if it takes about ten hours per patient, per year – for one condition.

How long does a GP get with each patient? On average, ten minutes, six times a year. That is, to deal with everything.

There are a number of interconnected reasons why regulations and targets and guidelines cannot, currently, be reversed, and I intend to look at a couple of the most important in the next blog.

1:https://www.pulsetoday.co.uk/news/workload/nice-out-of-touch-with-reality-of-general-practice-say-gp-leaders/

2: https://www.nice.org.uk/guidance/ng136/resources/hypertension-in-adults-diagnosis-and-management-pdf-66141722710213

What is wrong with the NHS? – Part 3

78 Replies

27th November 2023

Relentlessly falling productivity (Part a).

Regulatory constraints.

I was in the midst of writing another blog on what is wrong with the NHS, happily highlighting a few of the many pointless tasks that get in the way of clinical work. But my attention kept being drawn to the more general issue of the widespread fall in productivity.

Here, from the report: ‘Is there really an NHS productivity crisis?’

It is certainly true that measuring productivity in the health service is wrought with difficulty. But in our view, the available evidence strongly points to the NHS – or, at the very least, NHS hospitals – having an ongoing productivity problem.¹

Productivity is by far the biggest problem the NHS faces. The one ring that binds them all. And it must be dealt with. If productivity continues to fall, the NHS will steadily become less and less efficient. Until … until what?

In truth, I am not entirely sure. Nor I suppose is anyone else. The NHS cannot just go bust like a commercial business. Mainly because it has a hundred and fifty billion pounds pumped into it every year (~$200Bn). Which means it is doomed to stumble on for years. Kept upright by massive infusions of money? Until …

One trend already picking up pace is that and more people are paying for private medical care. Either directly, or through health insurance. At some point in the future, we will end up with a fully established two-tier system. The rich getting good medical care, the poor … not so much.

Whilst people going private will relieve some pressure on the NHS, it won’t impact on the fundamental issue. Which is that the UK taxpayer is throwing ever more money at the NHS, whilst getting less and less in return.

Why is it happening? Are staff working less hard?

‘Fewer patients being treated per staff member should not be interpreted as NHS staff working less hard. Staff are not the only input into the system. The point is that if there are more staff, or staff are working more hours, but the system is providing less care, then something appears to be going wrong.’

There is no evidence here for the staff slacking. So, what is this something of which they speak.

To see if anyone else had any brilliant insights, I read a few different reports. Here is one from the Institute for Government (whatever this institute is, exactly). It was entitled: ‘The NHS productivity puzzle. Why has hospital activity not increased in line with funding and staffing?’

It droned on for sixty-two pages, before limping to three main conclusions. First, that we don’t have enough beds, so hospitals are running above capacity, which make them more inefficient. True.

Quite how much more inefficient was not entirely clear. But we certainly could do without running hospitals full to bursting point. Just to give one example of why this damages productivity. If a hospital is completely full, then planned operations will have to be postponed, even cancelled. Because there are no beds available for recovery. Fewer operations = decreased productivity.

Second conclusion. The NHS is losing too many experienced staff who can’t stand working in the NHS any longer (my words). Due to ‘staff burnout, low morale and pay concerns’ (their words). Experienced staff tend to get things done faster, and better. When you lose them, things slow down, get done worse, and cost more.

This is also true. So, you would think staff retention should be a ruthless focus – but it is not. Not even remotely. ‘You want to leave… well then leave. There’s the door. Bye! … and good bloody riddance.’ This, by the way, is the current NHS staff retention strategy.

Finally, the report concluded that the NHS is badly undermanaged … cough, splutter, strangled gasp of disbelief. Although the authors also discovered the following…

‘We found that hospitals that had more managers or spent more on management were not rated as having higher quality management in the staff survey, nor did they have better performance. The implication being the overall hospital performance is dictated by clinical actions and behaviour, while hospital management is focused on administrative tasks ensuring regulatory constraints are met. The number of managers in each hospital was largely determined by the administrative tasks that needed to be fulfilled, with the scope of management circumscribed to these well-defined tasks.’²

As with many such reports, it managed to contradict itself from one sentence to the next. In one section it claims that the NHS is undermanaged, but when the authors looked at hospitals that spend more on management, there was no difference in performance.

Anyway, apart from a couple of relatively minor issues, there was nothing much in either report here, or indeed anywhere else, to explain the widening productivity gap. Which is a common finding of such high-level reviews. Report writers very rarely bother to visit hospitals and speak to the staff, who might be able to enlighten them.

So, I thought I would have a go. I began by going back to basics, starting with two key facts.

Fact number one. There are far more clinical staff working in the NHS:

‘Hospitals had 15.8% more consultants, 24.6% more junior doctors, 19.5% more nurses and health visitors, and 18.5% more clinical support staff in January to July 2023 than in January to July 2019….’

Overall, around twenty per cent more clinical staff:

‘But in the first nine months of 2023, they had 4.3% fewer emergency admissions and 1.3% fewer non-emergency admissions than over the same period in 2019. They carried out 1.8% more outpatient appointments and 0.8% more treatments from the waiting list than in 2019. This means that the number of patients treated per staff member – one crude measure of productivity – has fallen substantially.’¹

Fact number two. There has been no increase in clinical output.

Which means that in the last four to five years, productivity has fallen by around twenty per cent. If it keeps going down at this rate, in twenty years’ time, the NHS will be doing nothing at all.

By the way, clinical output means activities such as, seeing a patient in accident and emergency, or in the outpatient department. Or carrying out an operation, or doing a scan, and so on and so forth. Otherwise known as clinical activity. Consulting, scanning, diagnosing, treating, operating. Which is what hospitals, and GPs of course, are there to do.

Was there any evidence to be found in this second report that the staff were working twenty per cent less hard? Nope. My own observation is that clinical staff are working harder than ever. Work, work, busy, busy, chop, chop, bang, bang.

A view reinforced by the fact that healthcare workers are suffering a crisis of ‘burnout and low morale’ … and also taking far more sick leave. In addition, they are quitting, in droves. These are hardly strong indicators that the workers are all lounging about in cushy jobs.

Bringing these facts together, what we have is twenty per cent more staff, working just as hard, probably harder. Yet, they are creating no additional clinical outcomes. Where does this leave us?

There is only one possible conclusion. Which is the following. At least twenty per-cent of the work that clinical staff are doing is non-productive.

I suppose this is another statement of the bleeding obvious. But at least it does get us looking in the right direction, towards non-productive work. At which point the next obvious question arises. What is all this additional, non-productive work?

One clue is to be found in the report I quoted earlier, and two key statements that it contains.

Statement one: ‘hospital performance is dictated by clinical actions and behaviour.’

Statement two: ‘hospital management is focused on ‘administrative tasks’ ensuring regulatory constraints are met.

Here, I believe, we find ourselves looking directly into the heart of the problem. The underlying disease. The dichotomy, the split. The war within healthcare. Whatever you want to call it.

Which is that clinical staff do clinical work, and produce clinical outcomes, and therefore drive productivity. On the other hand, the primary role of management is to do something else. Namely, fulfil administrative tasks.

‘The number of managers in each hospital was largely determined by the administrative tasks that needed to be fulfilled, with the scope of management circumscribed to these well-defined tasks.’

As a manager might say, but never would. ‘You do clinical stuff; we will do management.’ And never the twain shall meet.

One of the first things people say to me, whenever a discussion turns to the NHS, is that there are far too many managers. ‘They don’t do anything. We should sack them all.’ Well … it certainly sounds tempting. The truth is that I have no idea if we have too many managers, or not enough managers, or just the right number.

What I can tell you is that, instead of having a tight focus on helping clinical staff do more productive work …

‘…hospital management is focused on administrative tasks ensuring regulatory constraints are met.’

And what is a regulatory constraint when it’s at home? Don’t you just hate language that means almost nothing, to almost everyone. A regulatory constraint is something that regulators insist has to be done before you can get round to all that pointless clinical stuff, like seeing a patient. Regulatory constraints, in turn, are met by the many and varied administrative tasks.

Where to start in attempting to explain how administrative tasks play out in the day-to-day life of any healthcare worker? On the basis that I know what I do best, I lay before you a few minor examples from my own work. I do realise each of them may seem trivial. With every additional task only adding a few minutes to each working day.

However … (exclamation mark) please bear in mind that I am only talking about one tiny area of medical practice, in one very small part of the NHS. Multiply this a thousand times, at least.

To begin.

In the GP Out of Hours department we used to have a locked drug box on the wall of a small side-room. It held a limited number of commonly prescribed medications. Having this stock meant that when the pharmacies were shut overnight, we could open the box, and hand out drugs directly to the patients. This saved them waiting till eight or nine the next morning to start treatment.

It used to be a pretty simple job. We wrote out a prescription, got the key to the box, opened it up, then handed the drugs to the patient. We left the prescription in the box to allow the used-up medications to be replaced.

There is now a behemoth of a multiple drawer thing in the department, that must have cost thousands. It looks a bit like those lockers where people can pick up on-line orders for Amazon. Somewhat smaller, yet vastly more complicated.

This locker has a touch-screen interface. It requires a smart card, two sets of key-codes – which keep changing, and no-one can remember what they are. A nurse must also accompany you, to ensure that … what? We don’t nick the drugs, I suppose. Locum doctors have no access to this locker and have to get another doctor to open it up.

This new, and vastly more complex system, adds about three to five minutes to the job in hand. Which, when you have fifteen minutes to see each patient, represents a very significant increase in time spent per patient. Up to thirty-three per cent.

Okay, yes, I can almost hear you thinking … trivial. Suck it up. Work a bit faster.

Here is another small thing from out of hours. In days gone by, when we went out on home visits, we plucked a handwritten prescription pad out of a drawer, then brought it back when we returned to base. Minus the scripts we had written.

Now, we can only take six scripts out with us, maximum. Not an entire pad – perish the thought. Once you have seen six patients you have to return to base to pick up more. And if you make a couple of mistakes, in writing out a couple of scripts, you can only see four patients before being dragged back to base. Which may be a half hour drive away, or more.

There is also an additional sign-out procedure for the prescriptions. On a good day this adds an extra couple of minutes. On a bad day, which is most days, we have to stand around and wait for the nurse to finish a phone consultation before they can countersign the book. Then the script prescriptions must be painstakingly counted out, with all serial numbers double checked. These must be matched up with the case numbers of the patients seen.

Sticking only to drug prescribing here. We have printers in each room for the electronic prescriptions we use at the base. At one time, if the paper for these electronic prescriptions ran out, we would pick a few new ones from boxes lying about the nurses’ room and load them back in the tray.

Now, the printable prescriptions are locked away, and the printer trays are also locked shut. Today, if you run out of paper for the printed prescriptions, which happens frequently, the task of re-filling the tray can take about ten minutes. Assuming the keys can be readily located.

Yes, yes, small additional tasks. Suck them up, see the patients faster. Make room in your day, lazy scum. But these few tasks add about half an hour to each working day, yes, I added them up. Thirty minutes out of each eight hours. You do the math(s).

In Japan they have a word for incremental improvements in the way work is done to improve quality and productivity. It is called Kaizen. Improvement in a gradual and methodical process. In the NHS we have anti-Kaizan. Anti-Kaizan means a reduction in productivity as a gradual and methodical process. Grinding, relentless.

My own term for this is ratchet world. It seems that almost every day, some new additional new regulatory constraint has been met .‘Click’, new task, goes the ratchet. The ratchet clicks ever tighter, the workload increases. Tomorrow ‘click.’ The next day. ’Click.’ Eventually all these clicks can no longer be sucked up. Inexorably they cut into real work.

In parallel with this, there is no longer any free time, for anyone. No moment for a chat and a cup of coffee. No time for bonding and creating a team. No fun, no joy left in work. Everyone is just head down, working harder and harder. In some A&E departments, doctors are being followed around by clipboard wielding managers, ensuring that they don’t dare to stop working. No cup of tea for you, scum.

Can I, as a doctor, announce. ‘I am not doing any of this crap, it is a waste of bloody time, and it is stopping me from seeing patients.’ No, I cannot. Because regulatory constraints take precedence over everything else. Absolute priority number one.

If you fail to meet a few regulatory constraints then, when the Care Quality Commission comes to visit – knives sharpened – you will FAIL your inspection. You will be MARKED DOWN. Your hospital trust will be deemed INADEQUATE!

There will be shame and public humiliation. The chief executive will have his head placed on a spike outside the hospital … maybe not quite. But failed inspections in other areas, such as schools, have recently led to suicides.

Unsurprisingly therefore, regulatory constraints are what managers relentlessly focus on. It is also what they demand that clinical staff focus on. So, I, like everyone else, sigh gently and get on with it. Do these endless additional administrative tasks make me happy in my work? Have a wild guess on that one.

Of course, it is not the managers who do the vast bulk of actual additional work. This is almost entirely done by clinical staff. It is the clinical staff filling in forms, and completing audits, and ticking drug boxes, and checking every patient for bed sores – no matter what age. Which means that ‘Administrative tasks’ are what clinical staff spend much of their time doing. The job of managers is to ensure that all regulatory constraints are met. Or else.

Although I do remember listening to the chief executive of a hospital trust on the radio saying that she employed eight people just to put together all the reports and audits that were demanded of her by the organisations above. This managerial workforce, alone, was costing her hospital trust two million pounds a year. Two million pounds worth of pure unadulterated productivity … not.

Winding back the ratchet I could write a hundred pages, a thousand pages, on all the additional paperwork, the additional forms, the clicks on the ratchet that have been introduced over the last few years. Instead, I give you a picture of Dr Gordon Caldwell, who is an A&E consultant. In this picture he is demonstrating the paperwork that has to be filled in when a patient arrives at the department. He is using his body as an indicator of scale. He is not dead.

These are the forms that now have to be completed to admit one patient in Accident and Emergency. He wrote an article about it all entitled ‘The NHS is drowning in paperwork.’³

Once again, I hasten to add that this is not the fault of hospital managers. They are simply following the orders handed down to them by others. And who, exactly, are these others?

They are the regulatory bodies that sit above the hospitals, controlling their every action. And there are a hell of a lot of them, churning out regulatory constraint after regulatory constraint. How many? Here from a report in the British Medical Journal:

‘We found that in total, more than 126 organisations are engaged in safety related regulatory activities in the NHS.’ ⁴

Here are the names of but a few. The Care Quality Commission (CQC), and NHSE (NHS England) and the Integrated Care Boards (ICBs) and NICE (The National Institute for Health and Care Excellence). The four horsemen of the apocalypse, as I like to think of them.

These bodies carry greater power and influence than most others. But each and every one of those one hundred and twenty-six is eternally busy, thinking up new regulatory constraints. New targets to be met, regulations that MUST be fulfilled. Administrative task after administrative task, my precious.

All of these tasks have one thing in common, and only one thing.

The all take time away from clinical work. They all reduce productivity. Every single one of them. These are the ‘anti-Kaizan’ jobs. Ratchet click after ratchet click.

Are they all necessary?

Would the NHS fall over sideways if we just stopped doing some of them, or all of them? Next time I will look at the rationale for the introduction of these million new anti-Kaizan jobs that are dragging the NHS – and social care – to their knees.

1: https://ifs.org.uk/articles/there-really-nhs-productivity-crisis

2: https://www.instituteforgovernment.org.uk/sites/default/files/2023-06/nhs-productivity-puzzle_0.pdf

3: https://www.spectator.co.uk/article/the-nhs-is-drowning-in-paperwork/

4: https://bmjopen.bmj.com/content/9/7/e028663

What is wrong with the NHS? Part two.

203 Replies

20th October 2023

(With lessons from, and for, all other health services around the world)

The Quality and Outcomes Framework

The Quality and Outcomes Framework (QOF) was to be the glittering triumph of Evidence Based Medicine. Many of the commonest and most deadly diseases afflicting humanity would be picked up early, then treated. Almost entirely by using medications which had proven benefits.

People at risk of cardiovascular disease would have their cholesterol levels checked. Then, if high, put on statins. They would have their blood pressure measured and put on antihypertensives. Other drugs to be added as required.

Anyone with diabetes would be prescribed blood sugar lowering medications. The entire list of QOF indicators is long, the funding large. The workload vast. General Practitioners gain QOF points for achieving certain targets, or ‘thresholds. For example, the percentage of their patients with high blood pressure where it is successfully lowered to achieve the required level e.g., < 140/90mmHg – or less¹.

In my view this is not medicine, it is accounting. It is also stultifyingly boring. Yet, at the same time, stressful, as you desperately attempt to record ever possible point, during a consultation. And patients wonder why their GP never looks up from the computer screen. They are probably playing QOF bingo.

Each point is worth a couple of hundred pounds, and several hundred points are on offer. The average UK practice, which has just over nine thousand patients, can earn around £135K (~$200K). Money which goes directly to the GP partners. It makes up a significant portion of their income.

The aim of all this? The aim is to reduce death and damage from nasty things such as heart attacks and strokes. With diabetes, the aim is also to reduce heart attacks and strokes… additionally kidney failure, and amputations, and blindness. All exceedingly worthwhile. There are many other QOF areas.

You could argue that GPs should have been bloody doing this anyway. It’s their job, after all?

Well. Possibly. Pushing that issue to one side (Conflict of Interest statement, I am a GP) I am more interested as to whether it has worked… whether it could ever have worked. Or why it is yet another reason why the NHS is falling over sideways, burdened with an ever-increasing workload, which is of almost no use whatsoever.

The supporters of QOF, and there are many, would argue that all this activity must do good. We have all the evidence we need from rigorously controlled clinical trials, no less. We know that lowering blood pressure is highly beneficial, as is lowering cholesterol and blood sugar levels. We simply know these things.

We do, we do, we do we do.

Or maybe – we don’t.

QOF was introduced in 2004. In 2017, a study in the BMJ reported the following:

‘England’s incentives that pay GPs for performance have not delivered better care for people with long term conditions, a systematic review of evidence has found.

The study said that there was “no convincing evidence” that the Quality and Outcomes Framework (QOF) influenced integration or coordination of care, self care or patients’ experiences, or improved any other outcomes for these patients. Rather, QOF may have “negative effects,” the reviewers said, and abolishing it may allow practices “to prioritise other activities which could lead to better care.” ²

A system that has added up to payments to GPs, since its introduction, of something in the region of £20Bn ($25Bn). The end result? It may have had ‘negative effects’. Which is a polite way of saying … not only does it do no good, but it is more likely to be causing harm.

In truth, it has cost a great deal more than £20Bn. One thing the NHS never, ever, considers is the time and money it takes to do such additional work? It is something economists call opportunity cost. What else could you be doing, if you were not doing this (useless) thing?

How much time has it swallowed up? I have no idea. I have not seen anyone attempt to quantify this. Or, if they have, I have failed to find it.

From my own experience I would estimate that, at a bare minimum, QOF takes up an hour each day. An hour of GP time is worth approximately £100. This figure is not GP pay. Despite what you read; we do not get paid that much. It includes building costs, other staff costs e.g., receptionists, heating, lighting – and all the other stuff you need to run a small business.

Now for a quick, back of a fag packet calculation. There are around thirty thousand GPs. Which means that, over and above the money directly paid out for meeting QOF ‘thresholds’, there are an additional three million pounds that need to be covered each and every day to do QOF work. Which is close to a billion a year. Another twenty billion or so, since introduction in 2004.

For which princely sum the NHS has gained, absolutely nothing at all. Apart from burnt out GPs, enormous waiting lists to see GPs. Annoyed and upset patients who end up going straight to overflowing A&E departments because they can’t be bothered to wait and see their own GP.

Here, right here, we see another reason why the NHS is going so badly wrong. And the underlying problem that drove the thinking behind QOF is mirrored in other health services around the world.

Other countries may not have the formalised system of QOF, but they too have guideline after guideline for managing long-term diseases. And meeting guidelines takes up vast amounts of time and effort. As mentioned in the previous article, it has been calculated that if Primary Care Physicians (GPs) in the US, were to follow all the treatments guidelines, it would take twenty-seven hours a day, all day, every day.

A stitch in time

QOF, and all other guidelines are based on the same principle which I shall call ‘the stitch in time strategy.’ Pick up diseases early, treat them early, and this will prevent downstream illnesses and death. Huzzah. This idea seems to mesmerise both doctors and politicians.

In truth, if you choose not to think about it too carefully it does sound good…must work surely. And, if it did, I would call it… a good thing. Bring it on. But no-one made any effort to find out if QOF was going to work, before rolling it out nationwide. There was no pilot study. There was no study of any sort. It was simply assumed that we had all the facts we needed We had all the evidence required. Such hubris.

There were those, and I was one of them, who were concerned that we were about to embark on the most gigantic healthcare experiment ever. One that could, potentially, do far more harm than good. I had many concerns, but I will just stick to one here.

Whilst we had evidence (from drug company sponsored clinical trials) demonstrating that certain actions e.g., taking an ACE-inhibitor after a heart attack, reduced the risk of future heart attacks. We did not know whether or not giving four different drugs – together – would result in greater benefit. Or, if the interactions between all four drugs might cancel out any benefit. Indeed, possibly cause harm.

Currently, after any heart attack, standard therapy includes four different medications. Often five, and if you have a raised blood sugar level, which many people are found to have, you get a couple of additional of drugs to lower blood sugar at the same time.

Has there been any trial looking at the cumulative benefit, or harm, of taking so many different drugs together? Compared to taking only one, or none? Nope. Never. The term for giving a large number of drugs simultaneously is polypharmacy.

Here is a recent study published in Nature:

‘Polypharmacy, hospitalization, and mortality risk: a nationwide cohort study’

‘Polypharmacy is a growing and major public health issue, particularly in the geriatric population. This study aimed to examine the association between polypharmacy and the risk of hospitalization and mortality,,,

Polypharmacy was associated with greater risk of hospitalization and death… Hence, polypharmacy was associated with a higher risk of hospitalization and all-cause death among elderly individuals.^’³

My main current job involves working in a unit looking after elderly people who, for one reason or another have ended up in hospital. Usually as a result of a fall, and a resulting injury of some sort. Our job is to fix them up and get them back home again.

In this unit we use drug charts called a wardex. These have sixteen spaces available for regular medications. Last time I looked, fifty per cent of patients needed two drug charts, because they were taking more than sixteen different medications. Ergo there was no room for them all on a single wardex This explosion in the number of medications prescribed is mainly a result of GPs trying to meet QOF thresholds.

It is now widely accepted, by anyone who has looked at this issue, that polypharmacy increases mortality. However, if I dare to take patient off a single drug then, when that patient goes home, there are often howls of protest. I have had several letters of complaint.

It seems that we are stuck with a system that costs billions, takes up a huge amount of GP time, and effort, and has achieved nothing other than ‘negative effects.’ It has also created mass polypharmacy which I know (from a great deal of other research) does harm.

1: https://www.england.nhs.uk/wp-content/uploads/2023/03/PRN00289-quality-and-outcomes-framework-guidance-for-2023-24.pdf

2: https://www.bmj.com/content/358/bmj.j4493.full 3: https://www.nature.com/articles/s41598-020-75888-8#:~:text=Hence%2C%20polypharmacy%20was%20associated%20with,cause%20death%20among%20elderly%20individuals.

What is wrong with the NHS?

134 Replies

9th October 2023

(With lessons from, and for, all other health services around the world)

Whilst awaiting the Judgement on my libel trial – three months from the hearing and counting – I decided to write about things other than statins and cholesterol. Lest I damage our case in some unforeseeable way. I do this humbly, as a public service. To keep people informed, and perhaps amused. Today, I shall touch upon the issue of:

Spending vast amounts of time on things that are almost completely useless.

Guidelines. Guidelines, guidelines, and more guidelines – and other mandatory stuff. These cascade down upon all health services from on high. As a starting point, and mainly because it is the most recent thing to hit my desk, we can cast our eye over gambling.

It’s true that many people’s lives are destroyed by gambling. But is it an illness, or a disease? NHS mental health director Claire Murdoch certainly thinks so. In the most recent missive from National Institute for Health and Care Excellence (NICE) Dr Murdoch not only describes gambling a disease, but a ‘cruel’ disease. Unlike all those cute and cuddly diseases we deal with on a daily basis. As she states:

‘Gambling addiction is a cruel disease that destroys people’s lives. We will work with NICE on this consultation process.’ ¹

Here from the draft guidelines:

‘Health professionals should ask people about gambling if they attend a health check or GP appointment with a mental health problem, in a similar way to how people are asked about their smoking and alcohol consumption, according to new draft guidance from NICE.’

As you may have gathered from this, asking people about their gambling hasn’t happened yet, but it will. Once NICE has reached the dread stage of a consultation process, it is basically a done deal. ‘We shall consult with all relevant ‘stakeholders*’, then do exactly what we have already decided to do’. Yes, I do love a consultation. ‘We consulted, but we heard only what we wanted to hear, and ignored everything else.’

*stakeholder is a word that, in my humble opinion, should be removed from the Oxford English Dictionary. It increases my BP to dangerous levels.

As for asking about gambling, and all the additional work that will inevitably be associated with this. Forms to be filled, appointments to be made, audits to be done. But if it helps people with gambling then this is all fine, wonderful, super great?

Or maybe not. As I say to nurses, when some new ‘thing’ – which absolutely must be done – thuds onto their desk. Ask them (whoever them may be) what you can now stop doing. If we assume that nurses are busy, and they sure are, you can’t simply squeeze extra stuff into their working day. Something has to give.

But in the health service nothing ever gives. Everything is additional work. Everything is an add-on to a service that is, currently, on its knees. Does anyone ever think. Hold on. It would be nice to do this, if there was any time left in the day. But right now, there isn’t.

Last week I spent two hours of my life, that I shall never get back, doing the Oliver McGowan Mandatory Training course on learning disability and autism. This was recently introduced by another body, the Care Quality Commission (CQC) – don’t ask. The CQC employs dementors, who descend upon their victims and suck out their very soul. ‘And why have you not met the falls audit target of 99%.’ Evil cackle.

As for the Oliver McGowan training itself:

‘The requirement states that CQC regulated service providers must ensure their staff receive training on learning disability and autism which is appropriate to the person’s role. Employers can refer to The Oliver McGowan Mandatory Training.’

Again, fine, wonderful, super great? We should all know how to work with these people better. In truth I found it repetitive, dull and patronising. And I learned nothing that I did not already know. In my opinion it could be summed up in nine words ‘Be nice to those with learning disability, and autism.’ Or else?

However, it is mandatory. Which means I had no say in the matter. Nor do the other 1.27 million people who work in the NHS. The on-line system also detects if you have wandered off for a chat and a coffee, then takes you right back to the beginning. Bastards.

I feel that you can look at this a couple of ways.

One: It is just two hours of around two thousand or so that make up your working year. One thousandth of your working life. So, suck it up and stop complaining. Get with the programme.

Two: 1.27 million people spending two hours on a mandatory training course represents 2.54 million hours. This is one thousand three hundred years of NHS staff time. Gone, never to return. At a cost of many, many, many, millions. Millions that could have been spend on something else. Such as patient care?

Earlier this year I was interested to discover the following fact. If every doctor in the US were to follow all the guidelines for disease management that are issued by various medical groups, it would require them to work twenty-seven hours a day.

‘Primary care providers (PCPs) were estimated to require 26.7 h/day, comprising of 14.1 h/day for preventive care, 7.2 h/day for chronic disease care, 2.2 h/day for acute care, and 3.2 h/day for documentation and inbox management. With team-based care, PCPs were estimated to require 9.3 h per day (2.0 h/day for preventive care and 3.6 h/day for chronic disease care, 1.1 h/day for acute care, and 2.6 h/day for documentation and inbox management).’ ²

I am just guessing here. But I don’t believe that primary care providers in the US are actually working twenty-six point seven hours a day. Ergo, these lazy swines are not following all the guidelines. So, which ones are they not doing? And does it matter? Has anyone noticed?

In the UK NICE guidelines cascade upon doctors in the UK like confetti… silage, the plague (insert metaphor of choice here). Some of the individual guidelines are more than six hundred pages long. I read one once, from start to finish once. By the time I finished it, I had forgotten why I bothered in the first place. It took well over a week. I ended up none the wiser.

But it does not stop with NICE and the CQC. A couple of years back, there was a study in the British Medical Journal entitled: ‘Patient safety regulation in the NHS: mapping the regulatory landscape of healthcare.’

Their main finding:

‘We found that in total, more than 126 organisations are engaged in safety related regulatory activities in the NHS.’ ³

All of them, I presume, have but one aim. To introduce new stuff that simply must be done, by order of the management. Ideally by making it mandatory. Each activity, I suppose, has some evidence to back it up. Evidence that is, if you care to look, often very weak. It sometimes just seems to be someone’s hobby-horse, picked up by a politician who wants to bask the glow of introducing some ‘wonderful’ new life saving thing.

Weak or not, on it goes. And on and on….Gradually the proportion of time left to look after patients shrinks ever further. After all, it is the only part of the working day left from which you can steal time. All else is filled with audits, and measurements, and various complex scoring charts, and meeting targets and writing and writing, and writing and writing. And writing and writing.

In this short blog, I have but scratched the surface of the endless additional work that is required in NHS, and all other health services around the world. It leads to, what I call ratchet world. Each day brings an extra piece of work ‘click’. This ratchet never loosens, it only ever tightens. The pressure and stress increases with each malignant click. More and more work, less and less useful activity can be done.

Next time I will introduce you to QOF. Perhaps the greatest waste of time and resources in the history of medicine.

You may also enjoy my metaphor of the Terrible Trivium. Stolen shamefacedly from the book ‘The Phantom Tollbooth.’

1: https://www.nice.org.uk/news/article/nice-recommends-healthcare-professionals-ask-people-about-gambling-in-new-draft-guidance-out-for-consultation-today

2: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9848034/ 3: https://bmjopen.bmj.com/content/9/7/e028663

Libel Case

4th June 2023

I have been silent and off-line for a while. I am not unwell, but thanks for asking. There is a court case coming up in the High Court in London on the 3^rd of July. I am suing the Mail on Sunday, along with Zoe Harcombe. This is complex and highly time-consuming case, and there are many sensitive issues on the line.

It was reported in the BMJ last year:

The controversy over the benefits of statins is set to be aired in the High Court in London, in what the senior libel judge has described as the “most significant piece of defamation litigation that I have seen in a very long time.”

Mr Justice Nicklin made the comment in a preliminary ruling in a libel action by Malcolm Kendrick, a GP, and Zoe Harcombe, a researcher, author, and blogger with a PhD in public health nutrition, against Associated Newspapers, publishers of the Mail on Sunday and Mail Online, over articles that labelled them “statin deniers” whose “deadly propaganda” had endangered lives.

In the judgment Nicklin ordered that the case should be heard in two tranches: a preliminary trial of certain issues, followed by a main trial. “It is no exaggeration to say that the parameters of this litigation are very substantial,” he said.

Kendrick and Harcombe are suing over articles published in the print edition of the Mail on Sunday and in Mail Online in March 2019. A news story in the paper was headlined “Statin deniers are putting patients at risk says Minister.”

https://www.bmj.com/content/376/bmj.o741

Watch this space, as they say.

Dr Zoë Harcombe and Dr Malcolm Kendrick have brought libel proceedings against both the publisher of The Mail on Sunday and the newspaper’s Health Editor, Barney Calman, over a series of articles first published in March 2019 in the news and health section. Dr Harcombe and Dr Kendrick complain that the Mail on Sunday made a series of libellous allegations, attacking their professional integrity with reference to their public statements and writings concerning the use and efficacy of statin therapy. Due to the unusual complexity of the case, it has been split into two trials. At a trial in July (Trial 1) , the court will decide, among other central issues, the meaning of the articles of which complaint is made, whether they were an expression of opinion by Mr Calman or a statement of fact and whether the defendants are entitled to rely on a public interest defence. The court at Trial 1 will not have to determine the truth or otherwise of the published allegations, and the question of what the defendants have to prove to be true, and whether they can defend their statements as expressions of opinion will depend on the outcome of Trial 1. The focus is on what was said by Mr Calman about the claimants and whether that can be defended.

Please note that comments have been disabled as this is an ongoing case.

Broken Science Initiative

247 Replies

17th March 2023

Recently, I was in Phoenix Arizona for a few days to attend the Broken Science Initiative Conference. This organisation was set up by Greg Glassman, who founded CrossFit, and Emily Kaplan, a media expert. The title of the organisation may give you a clue as to its purpose.

For my part I gave a presentation on medical research, and where I believe it has gone wrong. How I had once been a happy medic believing everything I was told … well almost.

Then, one day I took the red pill. Suddenly, I became uncomfortably aware that we were all being kept in a vast goo-filled factory, guarded by evil metallic robots who were trying to harvest our electricity for their own ends. Nothing was as it had seemed.

In the film, the Matrix, I was never quite sure why solar panels wouldn’t do the job of electricity generation. Also, I was never quite sure what the ‘ends’ of the robots were either. But hey, why ruin a perfectly good yarn.

In truth my conversion was not that sudden. It was a rather more gradual descent through the layers Dante’s Inferno. A painful and growing realisation that medical research was horribly …. broken. Biased and corrupted.

This was not, and is not, a comfortable place to be. In part because I am surrounded by fellow doctors who seem perfectly content with the way things are. They simply do not question any of the research which drives the guidelines that their practice is based on. The Broken Science.

Having said this, I do feel the need to say that not all medical research is broken. Some is excellent. And there are many good people out there. However, within those areas of medicine, where there are vast sums of money to be made, medical science took a fateful turn towards the dark side.

Luckily for me – and this is something that has kept me sane – I have come across many other fantastic people on my lonely travels. Bruce Charlton for example, with his masterful paper ‘Zombie science: a sinister consequence of evaluating scientific theories purely on the basis of enlightened self-interest.’

‘…most scientists are quite willing to pursue wrong ideas for so long as they are rewarded with a better chance of achieving more grants, publications and status.’

I fully agree with this sentiment. When people ask me, what has gone wrong with medical research my reply is usually. ‘Money’. When they ask me what else, I reply, ‘More money’. Yes, but what else? ‘Even more money’. Yes but…

The end result of replacing science with money has been a terrible distortion of research. Followed by distortion of clinical guidelines, followed by people taking medications that very often do more harm than good. Followed by people dying – early.

Why do I believe that medicines may now be doing more harm than good? The honest answer is that I can’t know for sure, because nothing is absolutely certain in this life.

However, what I do know is that the US has by far the greatest healthcare expenditure in the world. $4,300,000,000,000.00 per year (four point three trillion dollars, or $12,914 per person). Yet, life expectancy in the US is around five years lower than in any comparable country. Lower than in Poland, for example, which spends just over $1,000 dollars per year.

In the US there are certainly more and more, and more and more drugs. Polypharmacy is now the norm. If all these medications were truly as wonderful as they were supposed to be, life expectancy should be going up. At the very worst, there would be stasis, i.e., no improvement.

Instead, despite these trillions of dollars being spent, life expectancy has been falling. It was falling before Covid, and the downward trend has continued. Perhaps most telling is that Covid had a catastrophic impact on life expectancy in the US. Not simply due to Covid deaths, but from everything else as well. You spend $4,300,000,000,000.00 a year and what do you get? A system so rotten that it falls apart in a strong wind.

The graph below demonstrates that during the Covid years, the US suffered a greater fall in life expectancy than Poland. This is despite spending twelve times as much per head of population. Compare this disastrous result with, say, Sweden – here’s a clue, look towards the top of the graph. The country that famously did not lock down¹.

Yes, Sweden … Regarding that country, here is an article from the Guardian Newspaper in March 2020. Headline: ‘’They are leading us to catastrophe’: Sweden’s coronavirus stoicism begins to jar.’

It feels surreal in Sweden just now. Working from my local cafe, I terror-scroll through Twitter seeing clips of deserted cities, or army trucks transporting the dead in Italy, surrounded by the usual groups of chatty teenagers, mothers with babies and the occasional freelancer.

Outdoors, couples stroll arm in arm in the spring sunshine; Malmö’s cafe terraces do a brisk trade. On the beach and surrounding parkland at Sibbarp there were picnics and barbecues this weekend; the adjoining skate park and playground were rammed. No one was wearing a mask.

The global pandemic has closed down Europe’s economies and confined millions of people across the continent to their homes. But here, schools, gyms, and (fully stocked) shops remain open, as do the borders. Bars and restaurants continue to serve, and trains and buses are still shuttling people all over the country. You can even, if you wish, go to the cinema (it’s mainly indie fare: The Peanut Butter Falcon and Mr Jones were on at my local arthouse over the weekend).

The precautions that Swedes have been advised to adopt – no gatherings of more than 50 people (revised down from 500 last Friday), avoid social contact if over 70 or ill, try to work from home, table service only in bars and restaurants – seem to have allayed public fears that the shocking images from hospitals in Italy and Spain could be repeated here.

The prime minister, Stefan Löfven, has urged Swedes to behave “as adults” and not to spread “panic or rumours”.

Panic, though, is exactly what many within Sweden’s scientific and medical community are starting to feel. A petition signed by more than 2,000 doctors, scientists, and professors last week – including the chairman of the Nobel Foundation, Prof Carl-Henrik Heldin – called on the government to introduce more stringent containment measures. “We’re not testing enough, we’re not tracking, we’re not isolating enough – we have let the virus loose,” said Prof Cecilia Söderberg-Nauclér, a virus immunology researcher at the Karolinska Institute. “They are leading us to catastrophe.” ²

Ah yes, the ‘science’ of lockdowns. The medical and scientific community of Sweden, the Nobel Foundation, the Karolinska Institute were all of one voice. They all agreed that …. ‘They are leading us to catastrophe.’ Yup, a catastrophe indeed. So catastrophic that you cannot see any change in overall mortality over the two pandemic years. Look towards the bottom of the graph for the US.

In this case, the medical and scientific community were not driven by money to enforce stupid and damaging actions based on Broken Science. At least not at first. They were driven by panic, and the need to fit in with their peers, and desperate need to do something, anything.

Evidence that what they were doing was probably useless was (and remains) swept aside by a scientific community no longer capable of independent thought. Broken science indeed. Money came to this party rather later on, when there were hundreds of billions to be made from vaccines. And boy, if you really want to see Broken Science in full cry…

Getting back on track. What happens next with the Broken Science initiative? A lot, I hope. I shall be writing articles for them, and giving talks. I shall be making as much noise as possible. We will work hard to try and bring science back from the dark place it finds itself in. And if we don’t. Well, at least we tried.³

1: https://www.scientificamerican.com/article/why-life-expectancy-keeps-dropping-in-the-u-s-as-other-countries-bounce-back1/

2: https://www.theguardian.com/world/2020/mar/30/catastrophe-sweden-coronavirus-stoicism-lockdown-europe

3: https://brokenscience.org/

Returning to COVID19

417 Replies

31st January 2023

With the resignation of Jacinda Ardern, my thoughts were dragged back to Covid once more. Jacinda, as Prime Minster of New Zealand was the ultimate lockdown enforcer. She was feted round the world for her iron will, but I was not a fan, to put it mildly. Whenever I heard her speak, it brought to mind one of my most favourite quotes:

‘Of all tyrannies, a tyranny sincerely exercised for the good of its victims may be the most oppressive. It would be better to live under robber barons than under omnipotent moral busybodies. The robber baron’s cruelty may sometimes sleep, his cupidity may at some point be satiated; but those who torment us for our own good will torment us without end for they do so with the approval of their own conscience.’ C.S. Lewis

At one point she actually said the following:

“We will continue to be your single source of truth” “Unless you hear it from us, it is not the truth.’

If I ruled the world, anyone who said, that, or anything remotely like that, would be taken as far as possible from any position of power, never to be allowed anywhere near it again. Ever.

Yet, there are still many who believe her to have been a great and caring leader. She certainly hugged a lot of people with that well rehearsed pained/caring expression on her face.

Enough of that particular woman. But it got me thinking about lockdowns again and the whole worldwide madness of Covid. This was a time of such blundering idiocy that I find increasingly difficult to believe it ever happened. A bad dream.

‘The sky is falling, the sky is falling…’ Cue, everyone running about in panic. People, allegedly, dropping dead on the streets. Mortuaries, allegedly, overflowing. Freezer lorries, allegedly, stacked with dead bodies. Bring out your dead!

I worked with doctors who strode around the wards in positive pressure protective gear. There were GPs who simply refused to visit elderly residents in nursing homes. On my patch this was all GPs and all nursing homes. Meanwhile I happily visited away with a mask stuck to the top of my head.

During the Covid pandemic I travelled far past angry, to reach a point of utter weariness. Instead of becoming outraged by the latest rubbish that was being pronounced, I very nearly washed my hands of it. However, after learning of Jacinda’s resignation I roused myself to have another look at what actually did happen. Or to be more specific, what was the impact of Covid on overall mortality. The only outcome that really matters.

Rid your mind of the numbers claimed to have died of Covid. The, never to be clarified distinction between those who died ‘of’ or ‘with’ Covid. Or those who read an article on Covid and then, overwhelmed with fear, stepped out in front of a bus. Thus, becoming a Covid related…associated, something, anything to do with Covid, death.

Over time the Covid figures became so ridiculous and unreliable as to become meaningless. I should know, I wrote some of the death certificates myself. Let me think… ‘She died of COVID, she died of COVID not. Eeny, meeny, miney mo…’

I am not saying that Covid did not kill a large number of people. But the fact that deaths from influenza disappeared completely for two years tells me all I need to know. ‘Roll up, roll up, Ladies and Gentlemen, to see the amazing lady influenza disappear before your very eyes.’ An astonishing trick, all the way from La La Land. ‘You expect me to believe that? Ho, ho, ho, very funny….Oh, sorry, you actually do.’

Anyway, to clear my internal database of horribly unreliable figures, I went back to look at my favourite graphs on EuroMOMO. This website looks at overall mortality, and only overall mortality. Their data comes from countries who do know how to record deaths, honestly. Unlike some others, who shall be nameless … China.

However, the main reason to focus on EuroMOMO is that overall mortality is something you cannot fake. About the only thing you can do to manipulate the figures is hold back data for a month or two – which has been done, but not to any great degree. So, without further ado, let us move onto EuroMOMO. Below is a recent graph. I have deliberately removed most of the information you need to know what it is showing. I wanted people to avoid jumping to conclusions … that they might then find it difficult row back from.

I found myself examining this graph idly and thought. Imagine if you had no idea what you were looking at here. What would you think? It’s a squiggly line, yes. Very good, gold star. What else?

To give you a bit more detail. This is a graph of overall mortality, across a large number of European countries. All of those who provide data to the EuroMOMO database anyway. Norway, the ultimate European lockdown champion, has mysteriously disappeared from the database. Maybe they shall return …. I have begun to see everything as a conspiracy nowadays.

The graph itself begins in January 2017 and finishes in January 2023. As you can see (if not terribly clearly) there are two wavy dotted lines. These lines rise up in the winter, and then fall back down in the summer. Something seen every year. This is because, every year, more people die in the winter than in the summer.

Everyone thinks they know the reason for this winter summer effect, but I am not so sure they do. But that is an enormously complicated topic for another time.

The lower, dotted lines represent the ‘average’ mortality you would expect to see [with upper and lower ‘normal’ limits] year on year. Above those wavy dotted lines sits a solid spikey line. This represents the actual number of deaths that occurred. Not just from Covid, but from everything.

This does raise an immediate question. If we keep seeing more deaths than we would expect in the winter, year on year, then the ‘average’ number of deaths should rise? Thus, the wavy dotted lines ought to be going up and up, in the winter. But they don’t.

I am not entirely sure why this is not the case. But it is a statistical question of such mind-boggling complexity that I am, frankly, unable to answer it. I have looked into it, but I was scared off by the sheer scale and difficulty of the mathematics involved. Too many equations for my poor wee brain.

Anyway, this graph starts in the winter of 2017 and ends about now. The vertical lines are drawn at midnight on Dec 31^st each year. Which means that we have almost exactly six years of data. Excellent data, not manipulated in any way. I say this because, whilst the diagnosis of ‘Covid death’ may be disputed, the diagnosis of death cannot.

What stands out? Well, there was a very sharp peak of deaths in early 2020. This, as you have probably worked out, was when Covid first hit. I find it fascinating that it was so transient. It came, it went…gone. For a bit anyway.

Was the precipitous fall due to strict lockdowns? Some will doubtless argue this. However, we all locked down again in autumn 2020 and the death rate went up, and stayed up, for about six months. Until, that is, January came along, and it all settled down again. Which follows pretty much the pattern of 2017, 2108 and 2019. And the pattern of all pandemics. They come, and they go. Some a little earlier, some a little later.

What else do you see – now that we are all pretty much fully vaccinated? I think another thing that stands out is the sudden and sharp rise in mortality in November 2022. Which is virtually identical to the spike in 2020. Strange?

However, to my mind, the thing that shouts most loudly about this graph is that the years of Covid pandemic panic really do not look that much different from the previous three years. Half close your eyes, and there is almost nothing to see. The Covid peaks were a little higher, and a little longer – maybe.

If you knew nothing about the Covid pandemic I don’t think you would exclaim. ‘My God, look at these vast waves of death in 2020, 2021. What amazing, never seen before thing, happened here?’ Yes, first spike of early 2020 was certainly sharp, and unusual, but it was short. And very little different to the spike at the end of 2022. As for the rest?

Now, I would like to turn your attention to Germany. The most populous country in Europe. Here it is even more clear that the years of the Covid pandemic are not remotely unusual. If I had removed the calendar years off this graph, you would be hard pressed to spot the Covid pandemic. In truth, you would be more than hard pressed. You couldn’t.

The 2018 influenza spike was equally dramatic to Covid peak of 2021, if not more so. [You may have noticed that there was no peak in 2020] In addition, at the end of 2022, we have the highest peak of all. Future historians might well look at this graph and ask. ‘Tell me, why did the world go mad in 2020, and remain mad through 2021? Why did everyone lockdown in March 2020, and then do nothing whatsoever in December 2022?’

It almost goes without saying that, had we locked down again in November 2022, it would have been claimed that lockdown saved us all. Look at how quickly it came, then went. Well, they could have claimed it. But we didn’t lock down again, did we? In direct contrast to Germany. What of the people living in Luxembourg?

Luxembourg is surrounded by Belgium France and Germany. People move freely from one to the other, always have done, and still do. The ‘deadly’ Covid pandemic raged all around them. Here, absolutely nothing happened. Mind you, they also seem to have been unaffected by influenza.

Whilst the Germans were dying in large numbers in 2018, the Luxembourgians carried on serenely, not an extra death to be seen. Why? Discuss. [It seems that most/all countries unaffected by Covid, were also unaffected by earlier flu epidemics].

I know some of you may be thinking that Germany is much bigger than Luxembourg so … so what? If you are going to see an effect on mortality, you are more likely to see it happen, more dramatically, and rapidly, in a country with fewer people.

I should explain that the figures on the left axis, on the German and Luxembourg graphs (unlike the first one), do not represent total deaths, they are the ‘Z score’. That is, the deviation from the mean.

The upper dotted line represents a Z score of five. That means, five standard deviations above the mean. It has been decreed that if you hit more than five standard deviations above the mean, for any length of time, this is a signal that ‘something bad’ is happening. The alarm starts goes off, and epidemiologists run around bumping into each other. ‘The sky is falling… etc.’

If you use the Z score it makes no difference how large the population is. It has been specifically designed to make it possible to compare changes in overall mortality, in populations of very different sizes. I feel the need here to make it clear that Luxembourg is not that small. It has more than twice the population of Iceland, for example.

Enough of the maths already.

So, deep breath, and trying to bring all these random thoughts together. What does EuroMOMO tell us? It tells us that Covid was a bit worse than a bad flu season, with 2018 being a good reference point. [There have been far worse flu epidemics than 2018, and I am not talking about 1918/19].

What EuroMOMO makes most clear, at least to me, is that Covid was not, repeat not, a pandemic of unique power, and destructiveness. It could have never have remotely justified the drastic actions that were taken to combat it.

Belatedly, this is becoming recognised, as has the damage associated with lockdowns. Here is the abstract of an article from 2022. A bit dry, but worth a read. ‘Are Lockdowns Effective in Managing Pandemics?’

‘The present coronavirus crisis caused a major worldwide disruption which has not been experienced for decades. The lockdown-based crisis management was implemented by nearly all the countries, and studies confirming lockdown effectiveness can be found alongside the studies questioning it.

In this work, we performed a narrative review of the works studying the above effectiveness, as well as the historic experience of previous pandemics and risk-benefit analysis based on the connection of health and wealth. Our aim was to learn lessons and analyze ways to improve the management of similar events in the future.

The comparative analysis of different countries showed that the assumption of lockdowns’ effectiveness cannot be supported by evidence—neither regarding the present COVID-19 pandemic, nor regarding the 1918–1920 Spanish Flu and other less-severe pandemics in the past.

The price tag of lockdowns in terms of public health is high: by using the known connection between health and wealth, we estimate that lockdowns may claim 20 times more life years than they save. It is suggested therefore that a thorough cost-benefit analysis should be performed before imposing any lockdown for either COVID-19 or any future pandemic.’ ¹

In the face of such evidence, the argument for lockdown seems to be transforming into a somewhat pathetic whinge. ‘We didn’t know. It’s all very well people saying we shouldn’t have locked down now. We didn’t hear you saying it at the time. We were just following The Science, don’t blame us. Better safe than sorry. Don’t blame us …I think you’re being very nasty to us.’

This, of course, is nonsense. There were plenty of scientists arguing against lockdown at the time. However, they were all ruthlessly censored, attacked, and silenced. Experts such as Prof. John Ioannidis, Prof. Karol Sikora, Prof. Sunetra Gupta, Prof. Carl Heneghan. These last two UK professors argued very strenuously against lockdowns. They were ignored, then vilified. Here from an article written in January 2021:

‘…Sunetra Gupta. She’s been getting flak from the mob for months but it reached a crescendo yesterday when she was on the Today programme. Why is the BBC giving space to a nutter, people asked? She isn’t a nutter, of course. She’s an infectious disease epidemiologist at Oxford University. But she bristles against the COVID consensus and that makes her a bad person, virtually a witch, in the eyes of the zealous protectors of COVID orthodoxy. Professor Gupta has written about the barrage of abuse she receives via email. ‘Evil’, they call her.’

‘…her chief crime, judging from the hysterical commentary about her, is that she is critical of harsh lockdowns. She is a founder of the Great Barrington Declaration, which proposes that instead of locking down the whole of society we should shield the elderly and the vulnerable while allowing other people to carry on pretty much as normal. It is this perfectly legitimate discussion of a social and political question — the question of lockdown — that has earned Gupta the most ire.’ ²

I would like to point out that I was arguing against lockdown, right from the very beginning. Yes, I do enjoy saying, ‘I told you so’ from time to time. It is one of the few satisfactions I get in life nowadays. Here is a section from a blog I wrote in March 2020. Once again, right from the start:

‘…However, there is also a health downside associated with our current approach. Many people are also going to suffer and die, because of the actions we are currently taking. On the BBC, a man with cancer was being interviewed. Due to the shutdown, his operation is being put back by several months – at least. Others with cancer will not be getting treatment. The level of worry and anxiety will be massive.

Hip replacements are also being postponed and other, hugely beneficial interventions are not being done. Those with heart disease and diabetes will not be treated. Elderly people, with no support, may simply die of starvation in their own homes. Jobs will be lost, companies are going bust, suicides will go up. Psychosocial stress will be immense.

In my role, working in Out of Hours, we are being asked to watch out for abuse in the home. Because we know that children will now be more at risk, trapped in their houses. Also, partners will suffer greater physical abuse, stuck in the home, unable to get out. Not much fun.

Which means that we are certainly not looking at a zero-sum game here, where every case of COVID prevented, or treated, is one less death. There is a health cost.

There is also the impact of economic damage, which can be immense. I studied what happened in Russia, following the breakup of the Soviet Union, and the economic and social chaos that ensued. There was a massive spike in premature deaths.

In men, life expectancy fell by almost seven years, over a two to three-year period. A seven-year loss of life expectancy in seventy million men, is forty-nine million QALYs worth. It is certainly a far greater health disaster than COVID can possibly create…’ ³

And lo, the damage is coming to pass. Maybe not so many people dying of starvation as I predicted, at least not in the West. In poorer countries, however …

Another terrible thing that happened during lockdown was the vilification of anyone who dared question the official narrative. Yet almost everything they predicted has come true. Have the likes of Professor Gupta been forgiven and welcomed back into the fold? Have a wild guess on that one.

What of those who deliberately whipped up the panic and led the dreadful behavioural psychology teams. They quite deliberately frothed the population into a state of terror. What of those, whose ridiculous models kicked the whole damned thing off? The Professor Neil Fergusons of this land? Yes, you.

These people are all still comfortably ensconced, advising away. Their positions fully secure. In the UK they were mostly given knighthoods, damehoods, and other shiny gongs to impress their friends with. This, I find hard to swallow.

More worrying is that there will never be an honest review on the pandemic. Why, because so many people in positions of power would be seriously threatened by it. Which means that any such review will end up as a completely bland whitewash. ‘In general the actions taken were reasonable, and in a situation where so much was unknown, it was better to try and protect the public … blah, blah.’ Case closed.

The reality is that these lockdowns were a complete disaster. A complete disaster. The fact that we will never have a proper debate about them, means that we will learn nothing from what happened. This, in turn, means that another disaster is on the way. Those who should be listened to will be attacked, silenced and censored, again.

Those who got it all horribly wrong last time will be handed even greater powers … next time. The reason why lockdowns did not work, they will argue, is because they were not strict enough, or long enough. We need proper lockdowns next time. You have been warned. Cast your eyes over China.

I will leave you with the conclusion of the paper ‘Are lockdowns effective in managing pandemics?’

Neither previous pandemics nor COVID19 provide clear evidence that lockdowns help to prevent death in pandemic
Lockdowns are associated with a considerable human cost. Even if somewhat effective in preventing COVID19 death, they probably cause far more extensive (an order of magnitude or more) loss of life
A thorough risk-benefit analysis must be performed before imposing any lockdown in future.

Which can probably be summed in in the words: Primum non nocere. First, do no harm.

The central guiding principle of medicine that was hurled out of the window in March 2020 by people who seem not to exhibit a scrap of humility, or humanity. Nor apology.

1: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9368251/

2: https://www.spectator.co.uk/article/the-censorious-war-on-lockdown-sceptics/

3: https://drmalcolmkendrick.org/2020/03/29/a-health-economic-perspective-on-covid-19/

What is corruption – and why does it matter so much?

378 Replies

12th January 2023

Taking a small detour for the moment, I thought I would try and look at bit more closely at corruption. How do you define it? What is it? I believe if you are going to defeat something, you first need to understand what it is. Know thine enemy, as they say.

I began by looking up the word corruption in a dictionary, which defined it thus:

Corruption: ‘dishonest or fraudulent conduct by those in power, typically involving bribery.’

However, that is not really what I think of, when I think of corruption. An occasional trip to the theatre, or nice meal in a restaurant from time to time. Whilst imperfect, actions like this are not enough to constitute a major problem.

Corruption, to me, is when the entire system is taken over. Where almost everyone either takes part, or instead chooses to remain silent. At which point no actions can be trusted.

This is the situation that developed within FIFA (Fédération internationale de football association meaning International Association Football Federation) under Sepp Blatter’s leadership. Where hosting the football World Cup became an exercise in bribery from which no-one, and nothing, was immune.

Any man, or woman, who refused to take a bribe from FIFA was the exception, not the rule. Envelopes stuffed with cash were handed out in hotel rooms. At which point we had a completely corrupt organisation. Which is bad enough, on a relatively small scale, in an organisation that deals only with football.

On a larger scale, what happens when corruption affects everything? According to a global corruption index, the worst five countries in the world for corruption are:

Syria
North Korea
Congo, Dem. Rep
Yemen
South Sudan

The lowest five ‘risk’ countries for corruption are – starting with the best:

Norway
Finland
Sweden
Denmark
Estonia

It is no coincidence that the quality of life, and the wealth and happiness of people in these countries, indeed every country in the world, is closely tied to how corrupt those countries are. Indeed, the association between corruption, and quality of life, moves virtually in lock-stop.

Which means that corruption represents one of the gravest problems humanity faces. The worse it becomes, the more everything else falls apart. Given time, it eventually eats out the very structures that allowed it to exist in the first place. See under “The Roman Empire”.

Moving onto the bribery part of corruption. I also believe that bribery is about far more than just money. Whilst money represents the most obvious way to ‘bribe’ people. there is also power.

I quote you, Frank Underwood, the main fictional character in House of Cards.

‘Such a waste of talent. He chose money over power. Money is the Mc-mansion in Sarasota that starts falling apart after 10 years. Power is the old stone building that stands for centuries. I cannot respect someone who doesn’t see the difference.’

Then there is status. To stand tallest amongst your peers.

‘A good reputation is more valuable than money.’ Publilius Syros.

Nelson Mandela was uninterested in money, but at one time he was probably the most influential and highest status man in the world. Not, I hasten to add, that I think Nelson Mandela was in any way corrupt. But had he chosen to be …

Whilst it is difficult to define corruption perfectly, I would try to define it as … people doing things that are ‘paid’ for by others. Those who are paid gain what they greatly desire. Status, reputation, authority, power – all the same sort of thing, but not quite. And, of course, money. Those paying also gain what they want – usually more money.

For a system to be considered ‘corrupt’ a large number of those within it must take part. Those not actively taking bribes are also complicit, in that they have chosen to do nothing about it. They put up and/or they shut up. Worst of all, I think, is when they try to excuse it.

Money

Sticking to money for the moment and directing the discussion more specifically to the medical world. There was a time when the pharmaceutical industry was happy to pay doctors, and researchers, directly. Straight into the old bank account. No questions asked. Kerrching!

We would like you to give a lecture. Ten grand…kerrching! We want you to chair a think tank on the use of drugs in rheumatoid arthritis. Twenty grand … kerrching! We would like you to act as a consultant over the next two years in order to assist in our drug development programme. Fifty grand a year … kerrching! Run a clinical trial (put your name up as one of the main authors anyway). Don’t worry, you won’t actually have to write anything – or probably even read it. Two hundred grand … kerrching!

Or, taking a real-world example, let us have a look at Oxford Professor Sir Richard Doll. This is the man who, along with Bradford Hill, proved that smoking causes lung cancer. He is a hero to many within the medical profession.

As it turns out he was also paid $1,500 a day, for twenty years, by Monsanto. Which is a total of eleven million dollars. Kerrching!

At one point the Chemical Manufacturers Association, along with Dow Chemicals and ICI, dropped £15K into his bank account. This was for a review which cleared vinyl chloride of causing cancer – of any kind. This review was then used to defend the use of this chemical – now well recognised to be a cancer-causing agent – for over a decade.¹

In addition:

‘While he was being paid by Monsanto, Sir Richard wrote to a royal Australian commission investigating the potential cancer-causing properties of Agent Orange, made by Monsanto and used by the US in the Vietnam war. Sir Richard said there was no evidence that the chemical caused cancer.’

How does that make you feel? I have to say I was disappointed, to say the least. Up until this revelation I thought he was one of the good guys. A benevolent, Nelson Mandela-like figure:

However, following these revelations, he was not criticised. Instead, he was robustly defended – which I take as a key signal that corruption has taken over the system:

‘Professor John Toy, medical director of Cancer Research UK, which funded much of Sir Richard’s work, said times had changed and the accusations must be put into context. “Richard Doll’s lifelong service to public health has saved millions of lives. His pioneering work demonstrated the link between smoking and lung cancer and paved the way towards current efforts to reduce tobacco’s death toll,” he said. “In the days he was publishing it was not automatic for potential conflicts of interest to be declared in scientific papers.’

It might not have been automatic to declare conflicts of interest Professor Toy. But that does not make it right. If you are paid tens of millions by the industry, you are no longer a disinterested scientist, and you cannot pretend otherwise. It was wrong at the time, just as it is now, as it always will be. [Nowadays conflicts of interest are far more carefully hidden away].

There were other defenders, from Oxford University.

‘Yesterday, Sir Richard Peto, the Oxford-based epidemiologist who worked closely with him, said the allegations came from those who wanted to damage Sir Richard’s reputation for their own reasons. Sir Richard had always been open about his links with industry and gave all his fees to Green College, Oxford, the postgraduate institution he founded, he said.’

This statement was from the same article which began with these words

‘A world-famous British scientist failed to disclose that he held a paid consultancy with a chemical company for more than 20 years while investigating cancer risks in the industry.’

So it seems, Sir Richard Peto, that Sir Richard Doll was not open about his links with industry. Not in the slightest. No-one in the wider world had the faintest idea. Did those in Oxford University really know? If so, did they actually condone his work on Vinyl Chloride and Agent Orange? They certainly did not breathe a word of criticism.

Instead, we get … ‘the allegations came from those who wanted to damage Sir Richard’s eruption for their own reasons.’ In short, it is those making the allegations who are the bad guys. See under … children accusing priests of sexual abuse in the early days. ‘How dare evil children accuse these noble men of such things?’ Such things that they actually did, you mean.

And what reason could anyone have for damaging the reputation of man who was already dead, with these terrible ‘allegations?’ None was given, because there are no such reasons. Also, these were not ‘allegations’, they were facts. What should they have done, kept their mouths shut?

No, here is what those who worked with Sir Richard Doll should have said, or something very like it.

‘Sir Richard Doll did highly important work in proving that cigarettes cause lung cancer. Work that has benefitted hundreds of millions. However, he took large sums of money from commercial companies and then wrote papers in support of those companies, which resulted in a great deal of harm. We cannot condone these actions. This has seriously damaged his reputation, as it should. We will work to ensure that this type of situation never happens again.’

However, it seems that if you are seen as a ‘great’ person, who has done great work, you cannot possibly be accused of corruption. Even if the evidence is laid out before us all, in black and white.

Perhaps you think I am being rather harsh here. Focussing my attack on one ‘great’ man, now dead. In truth, I picked on this case for a couple of reasons. First, I want to make it clear that corruption is not a new thing in medical research – although it has greatly worsened – and gone undercover. Second, I hope to make it clear that those with a reputation for doing ‘great work’ are just as likely to be corrupt as anyone else.

In truth, they are the most likely to be corrupt. How so? Because they have achieved such high status that they have risen beyond suspicion. In addition, the ‘great ones’ have made themselves immensely valuable. Which means that they are actively sought out. They have both status, and influence.

Authority = power = influence

Influence ↔ money.

Influence is the currency here. And currency is very easily converted into money, and back again. If you can find the most influential ‘great person’ or ‘great institution’ or great ‘great medical journal.’ You pay them the money, and you get the influence you desire.

‘Sir Richard Doll himself says that vinyl chloride is perfectly safe, and how dare you argue with him – you pathetic nobody.’

Or, to quote the industry view on such matters:

‘Key Opinion Leader is regarded as the mastermind in the pharma industry. They’ve put in the time and research to be recognized by their peers as experts in their field. As a result, they have gained a reputation as a thought leader within their specific niche. Their expert opinions and actions can significantly affect the adoption of a new product/brand or the ability to influence consumer purchasing decisions.

Key Opinion Leaders are sort of like the avengers of the clinical research world. They can fill many different roles, and their skill sets are highly sought after by those in the know. A key opinion leader can be critically important in helping to educate physicians about a new drug. They can provide information about the working of drugs, which patient demographics can benefit the most, and what treatment regimens are most effective. KOLs can also offer their unique insights as early adopters of new therapies, which can help to identify and create brand acceptance in healthcare.’²

Nowadays there are entire companies dedicated to nurturing and developing Key Opinion Leaders and helping them work with pharmaceutical industry. Or vice-versa. Here, from the horse’s mouth. An article entitled: ‘KOL management in Pharma and Life Sciences.’

‘As pharmaceutical and life-sciences companies search for the most effective, efficient ways to manage collaboration with the physicians who conduct research, write articles, or speak on their behalf, relationship management of the interaction with these elite physicians, or key opinion leaders (KOLs), has ultimately emerged as an individual business discipline. Similar to CRM, KOL management is an essential component for marketers and medical staff throughout the life-cycle process of a specific drug or product.

By sustaining a business process that creates and maintains meaningful and collaborative relationships between KOLs and business functions from marketing to medical affairs, pharmaceutical and life-sciences companies can experience increased share of voice and accelerated adoptions at the global, national, and regional levels. A CEO of a major pharmaceuticals company recently told a group of analysts that effectively managing KOL relationships was essential to companies’ future products and market expansion.’ ³

Today, almost all of the great people (Key Opinion Leaders), institutions, medical societies and medical journals have been captured by the industry – to a greater or lesser extent. As far back as 2009, the long-time editor of the New England Journal of Medicine wrote these words. Words that I have quoted several times before, but they need almost endless repetition.

‘It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.’

What happened following this scathing attack? Nothing. Yet these words come from the editor of the most influential (highest impact factor) journal in the World. Someone who spent her entire working life reviewing the quality of medical research, assessing how robust medical guidelines are, and how trustworthy our ‘trusted’ physicians might be.

The answers to those questions being ‘rubbish’, ‘biased’ and ‘corrupt’ in that order.

I have occasionally asked myself: “What would be the worst effect of corruption of medical research”? Well, there are the obvious things. First that we cannot believe a damned thing that is published. With certain provisos – there are honest researchers out there.

Equally bad, or perhaps worse, doctors end up prescribing medicines that do no good, and possibly do harm. Based on biased physicians running biased trials, followed up by biased guidelines, to be published in biased journals.

These are, of course, in themselves terrible things.

But there is something else, which may actually be worse in the long run. If research is directed almost entirely towards ideas that support commercial goals, then this will end up crushing work that dares look in different directions. Try publishing a paper suggesting that cholesterol lowering is a waste of time, when the market for cholesterol lowering drugs is worth hundreds of billions.

Yes, you may be lucky enough to get something into a lower impact journal, but the bigger journals will block you completely. Come up with a different hypothesis as to what actually causes cardiovascular disease, and the big journals will not touch it with a bargepole.

Science only lives, and progresses, when the status quo is regularly attacked, and disrupted. But within a corrupt system, where the majority of funding comes from commercial sources, innovation grinds to a halt. Primarily because new ideas threaten profit. Try stating that Type II diabetes can be reversed with exercise and a low carbohydrate diet, and you are threatening a $200Bn market for diabetes medications. So, good luck with that.

Which leads me to perhaps the most soul-destroying article I have read recently. It was a review of disruptive science. By which the authors meant, the degree to which a scientific paper shakes up the field.

‘The authors reasoned that if a study was highly disruptive, subsequent research would be less likely to cite the study’s references, and instead cite the study itself. Using the citation data from 45 million manuscripts and 3.9 million patents, the researchers calculated a measure of disruptiveness, called the ‘CD index’, in which values ranged from –1 for the least disruptive work to 1 for the most disruptive.

The average CD index declined by more than 90% between 1945 and 2010 for research manuscripts (see ‘Disruptive science dwindles’), and by more than 78% from 1980 to 2010 for patents. Disruptiveness declined in all of the analysed research fields and patent types, even when factoring in potential differences in factors such as citation practices.’

Just have a look at the graph ⁴:

It is hard to think of a more depressing graph. Looking specifically at life sciences and biomedicine – otherwise known as medical research. It would seem that since the mid-1990s there has been virtually no disruptive science published – at all, anywhere.

The article itself states that ‘disruptive science has declined – and no-one knows why?’

Well, to my mind, there are two possibilities for this decline. The first is that we now know virtually everything across all scientific fields. Therefore, disruptive science has inevitably declined, because there is nothing new to be discovered. We simply know it all.

Of course, this echoes a famous comment by Lord Kelvin at the end of the nineteenth century. ‘There is nothing new to be discovered in physics now. All that remains is more and more precise measurement.’ Ahem, have you come across this chap Einstein by any chance?

The second possibility is that some factor, we shall call it factor K (for corruption) has virtually taken over science, particularly medical science. This factor when combined with money, factor M, has the effect of destroying innovation (I). Thus, squashing disruptive research (DR) flat.

The equation is simple. I ÷ (K x M) = DR

Innovation, divided by (corruption multiplied by money) = Disruption Index.

As the flow of industry money into research has multiplied, innovation and new ideas have shrivelled and died. This, anyway, is my working hypothesis. You may feel there are other reasons. In which case, I would be interested to hear them.

So, yes, I think that corruption is incredibly important. Particularly within the world of science, where mavericks and innovators are absolutely essential. Graphene, for example, an actual major scientific breakthrough. This was discovered by two scientists, Andrei Geim and Kostya Novoselov playing about with pencils and sticky tape in a laboratory in Manchester University.

Playing about in a lab! Research nowadays is driven by funding. Funding is driven by commercial applications. The ‘best’ researchers today know how to bring in money for their labs, and for their universities. Today, researchers need to be productive and drive the income stream. To quote Peter Higgs: ‘I wouldn’t be productive enough for today’s academic system.’

‘Peter Higgs, the British physicist who gave his name to the Higgs boson, believes no university would employ him in today’s academic system because he would not be considered “productive” enough.

The emeritus professor at Edinburgh University, who says he has never sent an email, browsed the internet or even made a mobile phone call, published fewer than 10 papers after his ground-breaking work, which identified the mechanism by which subatomic material acquires mass, was published in 1964.

He doubts a similar breakthrough could be achieved in today’s academic culture, because of the expectations on academics to collaborate and keep churning out papers. He said: “It’s difficult to imagine how I would ever have enough peace and quiet in the present sort of climate to do what I did in 1964.’ ⁵

‘Collaborate and keep churning out papers.’ This is the Henry T Ford school of research. We need more research! Quantity is what matters. Churning out papers requires money. To get money we have to sell … ourselves.

But innovative research, disruptive research, is not about quantity. It is about quality. One paper on subatomic materials acquiring mass. This is worth an infinite number of papers on how wonderful statins are. But an infinite number of papers on statins is what we now get.

Today, universities sell themselves on their collaboration with industry. Opinion leaders are hugely valuable to the industry, and therefore to their universities. They cannot afford to consider doing research which threatens the flow of money. So, they don’t.

This has become the medical research world that we live in today. It is no longer innovative, disruptive, or challenging. It is almost entirely bought and paid for. It has become Zombie Science. To quote Bruce Charlton, once again, from his paper. ‘Zombie science: a sinister consequence of evaluating scientific theories purely on the basis of enlightened self-interest.’

In the real world it looks more like most scientists are quite willing to pursue wrong ideas for so long as they are rewarded with a better chance of achieving more grants, publications and status. The classic account has it that bogus theories should readily be demolished by sceptical (or jealous) competitor scientists. However, in practice even the most conclusive ‘hatchet jobs’ may fail to kill, or even weaken, phoney hypotheses when they are backed-up with sufficient economic muscle in the form of lavish and sustained funding. And when a branch of science based on phoney theories serves a useful but non-scientific purpose, it may be kept-going indefinitely by continuous transfusions of cash from those whose interests it serves.’ ⁶

When the journal Nature notes that disruptive science has declined, and no-one knows why … I think this is utter balls. There are plenty of people who know why. The journal Nature also probably knows why. However, if they were to say why, it would open the door to something so big and ugly that no-one wants to even look at it, let alone deal with it.

Better to keep that door firmly shut. That door to the Zombie room. The place where undead science roams. Where innovation, disruption and science itself … died. In the end corruption consumes the host.

1: https://www.theguardian.com/science/2006/dec/08/smoking.frontpagenews

2: https://viseven.com/key-opinion-leaders-in-pharma/

3: KOL Management in Pharma and Life Sciences (destinationcrm.com)

4: ‘Disruptive’ science has declined — and no one knows why (nature.com)

5: https://www.theguardian.com/science/2013/dec/06/peter-higgs-boson-academic-system

6: https://pubmed.ncbi.nlm.nih.gov/18603380/

Drug regulation – How does it work?

262 Replies

31st December 2022

Before laying into the drug regulators, and their inexorable move towards the dark side, I thought I should try to explain a bit more about who decides what drugs should be used, and for what conditions.

Yes, I know, for most people this appears simple. The Federal Drugs Administration (FDA), in the US, or the European Medicines Agency (EMA), for the European Union, approve drugs for use in human beings, and that’s pretty much that.

Other countries have their own drug evaluation agencies, but l have no intention of looking at them in any detail. Also, if the FDA and EMEA approve drugs, then they are pretty much waved through elsewhere. A statement that will no doubt be assailed by various parties but I stand by it.

In short, if these two big agencies say a drug is safe – and effective enough – it is given their stamp of approval. It is then allowed to be prescribed … pretty much worldwide. Therefore, yes, the FDA/EMA represent the first hurdle that needs to be cleared, or your drug is going nowhere.

However, this once formidable hurdle has been hammered down into an almost unnoticeable speed bump, sitting about one inch above the ground. To quote from Forbes magazine – as far back as 2015 ‘The FDA Is Basically Approving Everything. Here’s The Data To Prove It.’¹

‘In 2008, companies asked for 134 approvals and got 75 of them, a 56% approval rate. That rate hovered steady in 2009 and 2010, and then rose to about 70% in 2011, 2012, and 2013. Last year it jumped to 77%, with 97 out of 126 requests for approval coming back positive. This year’s approval rate? It was 88%…

in reality, the FDA approval rate is more like 96%. Eliminating BioMedTracker’s counting of multiple uses for the same drug means FDA approved 23 drugs and rejected 1, Merck ’s anesthesia antidote, Bridion. Again, that means 19 of 20 new drug applications were approved.’

Drug companies have long since worked out how to neutralise the FDA and EMA. Which means that the big effort, nowadays, is made in working with other, increasingly important ‘agencies’, to achieve three main things:

Market expansion
New indications for use
Co-opting ‘your’ drugs into the guidelines

I think of FDA approval as establishing the initial bridgehead in a seaborne invasion. Once you have landed, you can then spread out to take over the rest of the country. This has become a massive and resource intensive exercise and involves many other different ‘agencies’ that need to be brought to heel.

In the UK, for example, a clear second barrier to drug use is (or more accurately ‘was’) the National Institute for Clinical and Health Excellence (NICE). This ‘agency’ was set up to decide if a drug, or other medical intervention, provided good value for money.

If not, NICE said no, and the drug would not be approved. Doctors could still prescribe such drugs, but it was much frowned upon, and could result in various sanctions.

When it started, in 1999, NICE decreed that no healthcare intervention should cost more than thirty thousand pounds for each year of perfect quality life that it provided (approx. $40K). One year of perfect health is known as one quality adjusted life year (1 QALY). Calculating QALYs is fraught with assumptions and models, and suchlike, which I am not going into here.

Where did this thirty thousand figure come from? The truth is that was plucked from thin air. Strangely, this figure has never increased, in well over twenty years. It is inflation proof. It is also endlessly flexible. Think of it as the pot of gold at the end of the rainbow. You know it is there, but it can never truly be seen, or pinned down. This allows for endless fudging to take place, depending on how the media and politicians react to their decisions.

The first ever judgement of NICE was to turn down the anti-flu drug Relenza. I think it was just to show how ruthless and anti-industry they were going to be. A flag rammed into the ground. ‘We own this territory.’ This caused the CEO of Glaxo Smith Kline (GSK) to hurl his toys out of the pram. Various drug companies sent a letter to Tony Blair, the Prime Minster at the time:

“We warned that NICE’s activities could have worldwide repercussions for sales of the medicines concerned and that it could send out deeply damaging signals about the future rewards for innovation. We received repeated assurances from Ministers and from Sir Michael Rawlins (head of the NICE) that our concerns were well understood and that NICE would not operate as a fourth hurdle for new medicines. The landmark ruling on Relenza makes it crystal clear that our worst fears were fully justified,” it said.

The letter went on: “the emergence of NICE as a new obstacle to market entry serves to wipe out, at a stroke, a key element of the UK’s competitive advantage in the global pharmaceutical industry. It is self-evident that any savings to the NHS resulting from restricting access to new medicines will be insignificant when set alongside the potential loss of the UK’s current international standing in the pharmaceutical industry.”

“Much damage has already been done by NICE’s recommendation….the government must act swiftly now to limit and repair the damage by making clear that its response to NICE will take full account of the wider implications of its activities and that new medicines approved by the MCA will continue to have immediate access to the NHS,” said Dr McKillop.’ ²

I think GSK threatened to pull out of the UK altogether. In the medical world we call the ‘I am going to scweam and scweam and scweam until I am sick, sick, sick.’ business strategy.

However, it did not take long before the industry ceased their pitiful screaming and realised the NICE could be one of their most valuable assets. How so? Primarily because other countries do not really have a NICE equivalent, and many of them look to the judgements of NICE for guidance. If NICE say yes, then they will almost always say yes as well. Bingo.

Ergo, if you manage to get NICE to say that your drug it not only safe and effective, but also cost-effective. This opens the doors worldwide. The market is yours. And so, inevitably, NICE has gone the way of the FDA. They now approve, pretty much everything. Increasingly, they don’t even bother to let anyone know how they worked out their figures.

For example, we can take a look at the drug Inclisiran. This is a cholesterol lowering injectable drug, known as a PCSK9-Inhibitor. A number of different PCSK-9 inhibitors have reached the market recently. They all lower cholesterol (LDL) more than statins – hooray (or perhaps not). They are all, also, mind-bogglingly more expensive.

A year’s supply of a statin now costs about thirty pounds (forty dollars) per year. At least it does in the UK. On the other hand, a one-year supply of a PCSK-9 inhibitor costs around five thousand. Some cost a bit more, some less. However, they are all at least one hundred times more expensive than statins, more like two hundred.

I once idly calculated that if everyone taking a statin were to move over to a PCSK9- Inhibitor instead, it would cost the NHS around sixty billion pounds a year. Which would mean cancelling almost all other activities. Hip replacements … you must be joking, no money left for that nonsense. Cholesterol lowering is what the NHS now does. And nothing else!

At this point you might be asking yourself. How could a drug with very few additional ‘benefits’ to a statin possibly manage to get approved by NICE? How did anyone manage to work this one out? You may be glad to know that I am not going to go through all the complicated trial results, calculations and suchlike here.

But you can, if you wish, read it all for yourself in the ‘evidence’ section of the NICE report on Inclisiran. All two hundred and forty-three pages of it. And good luck with that.³

Over the years these NICE reports have become utterly bonkers. They are now so long, so jargon filled, with statistics filling the air. They are also so very, very, very, boring. Some may say that this is a strategy used to stop any objections to their decisions. Primarily, because no-one could possibly be bothered reading the damned thing. Bullshit baffles brains.

Little do they know that I occasionally rouse myself to look at NICE reviews in detail. Even though some parts are beyond me. Here is one very brief example of jargon-filled obfuscation taken from page sixty-five of the Inclisiran report:

‘The time-adjusted percentage change in LDL-C from baseline after Day 90 and up to Day 540 was calculated from the MMRM. Linear combinations of the estimated means after Day 90 and up to Day 540 were used to compare treatment effects.

Treatment effects from these 100 MMRM analyses were then combined using Rubin’s Method (100) via the SAS PROC MIANALYZE procedure. The difference in the least squares means between treatment groups and corresponding two-sided 95% CI was provided for hypothesis testing.’

The MMRM analyses?
Rubin’s method?
The SAS PROC MIANALYZE procedure?

Search me guv.

To be honest I tend to skim these parts. This is on the basis that I have better things to do with my life than find out what the SAS PROC MIANALYZE procedure might be. Instead, I spend my time searching for the key facts that have been hidden away. The secret to the magic trick. The ‘Prestige.’

As with all magic tricks:

“The first part is called “The Pledge”. The magician shows you something ordinary: a deck of cards, a bird or a man. He shows you this object. Perhaps he asks you to inspect it to see if it is indeed real, unaltered, normal. But of course … it probably isn’t.”

“The second act is called “The Turn”. The magician takes the ordinary something and makes it do something extraordinary. Now you’re looking for the secret … but you won’t find it, because of course you’re not really looking. You don’t really want to know how it, say, disappeared. You want to be fooled.”

“But you wouldn’t clap yet. Because making something disappear isn’t enough; you have to bring it back. That’s why every magic trick has a third act, the hardest part, the part we call The Prestige.” ⁴

Where was the ‘Prestige’ with Inclisiran? I knew it was hidden somewhere deep within those two hundred and forty-three pages. My attention designed to be cunningly diverted by such things as the SAS PROC MIANALYZE procedure. Say what? My first clue as to where the Prestige lies can be found is on page one hundred and six (see below).

Just look at those thick black lines. Yes, here is a report by a tax-payer funded Government agency. But we are not allowed to see critical data. Such as, how many participants in the trial suffered an adverse event. Nor how many discontinued the drug and – perhaps most critically – how many died. Really, they are keeping all this a secret? Yes, indeed, they are. Here is another page I thought you might enjoy. It is page 112. It is a belter. All the information you need in one critical table

Oh no, it’s all been redacted – again. After this point there is page after page, after page, of black text and thick black lines. What does it actually say beneath the censored information?

We’re in the money

Come on, my honey

Let’s spend it, lend it,

Send it rolling around!

Moving on, the single most important thing for us to know, from a NICE report, is the following?

Is Inclisiran cost-effective? Or, to put it another way, can it provide more than 1QALY for each thirty thousand pounds it costs? In addition, can it really be that much more effective than statins. [In my opinion, nothing is more effective than statins. So, use nothing].

This, then, is the central NICE question. Is Inclisiran cost-effective, or not. I cannot answer this question, and nor can you – or anyone else outside NICE. Why not, you may ask. Well, to answer this question I present you with, but one small section, that looks at the cost-effectiveness of Inclisiran.

In this case cost-effectiveness on the treatment of Atherosclerotic Cardiovascular disease (ASCVD).

As you can see… you can’t see anything. You are not allowed to. This table can be found on page 211 by the way. Quite astonishingly, all the information on costs has been redacted. This table is followed by many other with all the figures redacted. How as this happened? Because Novartis will not allow NICE to show it to you.

What is the point of doing all this work, and publishing this enormous document, if all the critical information is to be kept secret? Kept secret from the very people who pay for all the damned work. NICE is taxpayer funded, its calculations should be transparent, and its decisions should be transparent. But they are not.

The simple fact is that the pharmaceutical industry has learned how to control NICE. It has become, like the FDA and the EMA, a ‘captured’ agency. On the outside it pretends to be a fully independent scourge of the pharmaceutical agency. In reality it does exactly what it is told – by the pharmaceutical industry.

In this case, the crowd goes wild, as the magician demonstrates his Inclisiran trick.

‘Ladies and gentlemen, here is a PCSK-9 inhibitor called Inclisiran. Look at it closely. Yes, examine it any way you like (note to self, make sure they don’t actually look at anything after page 100). It costs…. What does it cost Madam. Why cost is not the issue. What matters is whether or not it is cost-effective. Am I right, madam? My, your dress is so beautiful, and your hair. If I may say magnificent.’’

Woman nods and smiles.

‘Yes, you may be thinking … how can this drug possibly be cost-effective?’ Well, let me place this drug into the sealed box that we call NICE evaluation. Yes madam, a most impressive box indeed. Stamped with approval by, well, everyone. Yes, madam, everyone.’

Magician places Inclisiran into black box.

‘Now, we just need some money…. I shall stuff two million pounds into the box …’

Magician stuffs the box with money, then shakes it.

‘Hey presto.’ He opens the box. ‘Yes, as you can see Inclisiran is, indeed, cost-effective. Yes sir, it is indeed, magic … what’s that, you would like to see into the box yourself. Sorry, sir, we have to keep some of our secrets to ourself …. Yes, officer, if you could just take that gentleman out and arrest him for some reason or another…’

Nowadays, the tentacles of the pharmaceutical (and medical devices industry) wrap around far more agencies than just the FDA and EMA. And is not just NICE. It is the medical societies, the opinion leaders, the charities and – let us not forget – the politicians. All are caught up its deadly embrace. No-one escapes. If they do, they immediately become a conspiracy theorist.

In the next episode I shall turn my attention to the Universities, and those who work in them. Here lies, perhaps, the greatest source of power. A place where money can be converted into both academic and medical authority. Increasingly backed up by the force of law.

1: https://www.forbes.com/sites/matthewherper/2015/08/20/the-fda-is-basically-approving-everything-heres-the-data-to-prove-it/?sh=4dfb8edb5e0a

2: https://www.thepharmaletter.com/article/uk-s-nice-turns-nasty-rejecting-glaxo-wellcome-s-anti-flu-drug-relenza

3: https://www.nice.org.uk/guidance/ta733/evidence/committee-papers-pdf-9258232573 4: https://observer.com/2020/09/the-prestige-christopher-nolan-magic-trick/

Dr. Malcolm Kendrick

Scottish Doctor, author, speaker, sceptic

Does Sars-Cov-2 exist?

THE KENDRICK COVID ENQUIRY (As I humbly call it)

What went on during Covid?

Finally – the end (of the trial process)

Press Release

BETWEEN:-

AND BETWEEN:-

STATEMENT IN OPEN COURT

Solicitor for the Claimants

A little more on the trial

The legal case – naming a few names

A Win

A little more on the trial

We have a judgment (Part 1)

What’s wrong with the NHS? – part five

Very high LDL no impact on plaque progression

What’s wrong with the NHS? – Part 4

What is wrong with the NHS? – Part 3

What is wrong with the NHS? Part two.

What is wrong with the NHS?

Libel Case

Broken Science Initiative

Returning to COVID19

What is corruption – and why does it matter so much?

Drug regulation – How does it work?