Malcolm Kendrick is a Scottish doctor and author of The Great Cholesterol Con (2008). He has been a general practitioner for over 25 years and has worked with the European Society of Cardiology.
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 down 1.
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
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 31st 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.
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.
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.
[The Federal Aviation Authority (FAA), the Food and Drugs Administration, compare and contrast].
A while back I began to write a blog called. ‘We need a couple of plane crashes.’ Which may sound a little harsh. But the point I was hoping to make is that plane crashes make front page news around the world. They are highly visible, and terribly frightening. They certainly can’t be hidden away from the public.
One plane crash may not be seen as such a big deal, after all these things can happen. Two plane crashes, for the same reason, in the same make and model of plane. Now you’re talking. Planes will be grounded around the world. A massive investigation will take place. Headlines generated.
Outrage shall be expressed by politicians. The phrases: ‘heart-rending’, ‘my thoughts and prayers are with the families’ ‘we will strain every sinew’ ‘horrified’ will be greatly overused. Thesauruses shalt be scanned, searching out synonyms for terrible: shocking, horrifying, dreadful, appalling etc.
Yes, I am talking here about the Boeing Max 737 crash. With depressing inevitability, all the usual issues were uncovered. For example, the silencing of whistle-blowers prior to the crash. I enjoyed some of the internal memos that were discovered:
‘The messages contained harshly critical comments about the development of the 737 MAX, including one that said the plane was “designed by clowns who in turn are supervised by monkeys.”1
Oh yes, people in the company knew. They always do. Then silenced they are, yes.
In this case, though, we had an added bonus. The chief executive of Boeing tried to blame the pilots – ‘nothing to do with our super-safe planes’. This was the play book of the desperate. A man scattering blame in all directions – but his. A man who, it should be added, walked off with a $62.2m bonus… As compensation.
Oh well, at least he received no severance pay to go with it. So, he might just about be able to get by on his rather meagre compensation. Compensation! For what? Being an utterly heartless bastard. 1
As it turned out, the cause of the crashes was a new piece of technology designed to keep the plane from pitching up, or down, can’t remember which. It was required because Boeing were putting great big new engines on airframes that were not designed to take them. The airframe was launched in the 1960s, the new engines appeared fifty years later. It was a way to upgrade the 737 on the cheap.
‘We can make them fit. We can, we can.’ What, they can make them fit sixty years later. A period of time longer than it took to get from the Wright brothers original flight to the Boeing 737 itself. Think upon that.
Of course, they didn’t bother telling pilots that this ‘fudge-it’ system existed – or at least they didn’t tell most of them. So, when the plane suddenly decided to pitch up, or down, controlled by the new system, the pilots had no idea what the hell was going on.
The subsequent battle between computer, and pilot, ended up driving the planes into the ground. All of this was entirely, and absolutely, the fault of Boeing. Who, it appears, were well aware of exactly what had happened after the first crash. Yet they still tried to pin the blame on the pilots, and fought to keep the planes in the air.
Yes, this stuff really does restore your faith in humanity, does it not? Compensation of $62.2 million. I was thinking more along the lines of a very long jail sentence. Hey ho.
Then, attention moved to the Federal Aviation Administration (FAA) itself. The very agency whose job it is to ensure that planes are as safe as safe can be. Surely these guys should have picked up on this problem? Here are a couple of short sections from their mission statement:
‘Safety is our passion.
‘Integrity is our touchstone. We perform our duties honestly, with moral soundness, and with the highest level of ethics.’
I love mission statements like this. Yes, you always need a bit of ‘passion’. Tick! How about a splash of ‘moral soundness’ Tick! A soupcon of ‘the highest levels of ethics’. Tick!
Mission statements like this are to be savoured like a fine wine. They are the purest form of hypocrisy that mankind has ever aspired. A smorgasbord of fine sounding words, distilled to perfection. Heady, utterly meaningless. Just words, nothing more. Reading them fills me with almost painfully sharp snap of pleasure.
‘I think you will find this to be the utterly perfect vacuous mission statement, sir.’
‘Ah yes, bring me another glass. This time can we just add…. In the air, you’re in our care.’
‘Genuis, if I may say so.A Boeing vintage, sir.’
Of course, amongst all this passion, honesty, morality and, indeed ethics, Boeing’s penny-pinching actions sailed straight through the FAA. In truth, they didn’t sail straight through the FAA. Because, at the time, the FAA was perfectly content for Boeing to do many of their own safety checks.
‘The Federal Aviation Administration has for years allowed many aerospace companies to use their own workers in place of FAA inspectors, a system that is coming under scrutiny after two Boeing 737 Max jetliners crashed, killing the crews and passengers.
A total of 79 companies are allowed under federal policies to let engineers or other workers considered qualified report on safety to the FAA on systems deemed not to be the most critical rather than leaving all inspections to the government agency.
To critics, it’s a regulatory blind spot.
“The FAA decided to do safety on the cheap — which is neither safe nor cheap, and put the fox in charge of the henhouse,” said Sen. Richard Blumenthal, D-Conn., in a statement. He’s vowed to introduce legislation “so that the FAA is put back in charge of safety.” 2
‘Fox in charge of the henhouse’. Yup.
Whether or not the fox ever gets booted out of the henhouse is another question. I wouldn’t hold my breath on that one. However, what these two plane crashes certainly managed to achieve was to sharpen the world’s attention on the FAA. For a short moment, at least, the world woke from its slumbers, professed moral outrage then… then what?
Then the CEO of Boeing got a pay-off of $62.2 million, in compensation.
“346 people died. And yet, Dennis Muilenburg pressured regulators and put profits ahead of the safety of passengers, pilots, and flight attendants. He’ll walk away with an additional $62.2 million. This is corruption, plain and simple,” U.S. Senator Elizabeth Warren said on Twitter.
U.S. Representative Peter DeFazio, who chairs the House Transportation Committee, said minutes of a June 2013 meeting showed that Boeing sought to avoid expensive training and simulator requirements by misleading regulators about an anti-stall system called MCAS that was later tied to the two crashes that killed 346 people.’ 2
Yes, dear reader, you are right. If, that is, you just noticed that this blog has nothing much to do with the Food and Drugs Administration (FDA). However, when the FDA can’t be bothered to do their job with the required ‘passion’, ‘moral integrity’ ethics and a bit more passion stuck on top for good luck, three hundred and fifty dead would represent the smallest drop in a vast ocean.
If the FDA invites the fox into the henhouse, it may well be thousands, may hundreds of thousands, who die. But, and here is the kicker. It can be very difficult for anyone to know that it is it is taking place.
This is because there will be one death at a time, spread across the globe. You will not have an enormous impact crater. There will be no scattered wreckage, no children’s toy poignantly lying next to a manged plane seat for the media to focus their cameras on. Just one death at a time. At home, in a hospital. Final breath, gone.
Drip, drip, drip.
Dead, dead, dead.
Who dares disturb my slumbers?
This, from Harvard University
‘Few know that systematic reviews of hospital charts found that even properly prescribed drugs (aside from misprescribing, overdosing, or self-prescribing) cause about 1.9 million hospitalizations a year. Another 840,000 hospitalized patients are given drugs that cause serious adverse reactions for a total of 2.74 million serious adverse drug reactions.
About 128,000 people die from drugs prescribed to them. This makes prescription drugs a major health risk, ranking 4th with stroke as a leading cause of death. The European Commission estimates that adverse reactions from prescription drugs cause 200,000 deaths; so together, about 328,000 patients in the U.S. and Europe die from prescription drugs each year. The FDA does not acknowledge these facts and instead gathers a small fraction of the cases.’3
This is approximately one thousand times as many deaths as the Boeing Max 737 crashes, and it happens each and every year. To be pedantic this is a mere 947.98 times as many deaths. In addition, as the Harvard article also states:
‘Few people know that new prescription drugs have a one in five chance of causing serious reactions after they have been approved.’
As for the FDA. Well… ‘It does not acknowledge these facts.’
What on earth does this statement mean? The FDA can’t be bothered to check. Or they don’t believe in such grubby things as facts? Or is it just too much of a big scary problem to even contemplate? There is a bit of me that doesn’t blame them. A little tiny bit. ‘Just look at the size of those Augean stables. I ain’t cleaning that baby. No way.’
However, a much bigger bit thinks that this is really their job. Namely, to find out exactly how it is that ‘correctly’ prescribed medications are killing more than three hundred thousand people (US and Europe alone) per year.
You would think they might consider it a good idea to try and reduce this number, just a smidge? Nope, far easier to ‘not acknowledge these facts’. You certainly don’t have to do anything about a problem if you refuse to accept that there is a problem. Sorted. What shall the motto of the FDA be, I wonder.
‘Safety is our passion.
‘Integrity is our touchstone. We perform our duties honestly, with moral soundness, and with the highest level of ethics.’
Not.
So, next, I think we should have a look at what is going on in the FDA – as this is pretty much what is going on at every other drug evaluation agency in the world, to a greater of lesser extent. Also, where the FDA approves, others follow. They are very much the leaders of the pack
I though I should finish with something that you may wish to savour, like a fine wine. I include a couple of key sections of the Boeing mission statement.
We…
Lead on safety, quality, integrity and sustainability
In everything we do and in all aspects of our business, we will make safety our top priority, strive for first-time quality, hold ourselves to the highest ethical standards, and continue to support a sustainable future.
Foster a Just Culture grounded in humility, inclusion and transparency
Rooted in transparency, fairness and learning, a Just Culture creates an environment where everyone feels free to report errors and are treated fairly for making mistakes while being held accountable for negligence or malicious behaviour. The intent is to help all of us learn from mistakes to improve as individuals and as a company.4
By golly what a company this must be… Fine, fine words indeed.
‘There seems to be no study too fragmented, no hypothesis too trivial, no literature citation too biased or too egotistical, no design too warped, no methodology too bungled, no presentation of results too inaccurate, too obscure, and too contradictory, no analysis too self-serving, no argument too circular, no conclusions too trifling or too unjustified, and no grammar and syntax too offensive for a paper to end up in print.’ Drummond Rennie.
Somewhat damning?
It supports my considered opinion that medical research died decades ago. It is now populated by the undead to become, what could best be called, ‘Zombie science’. Or, possibly, the walking dead.
I would not be the first to think this. In truth, I nicked the term. Here is the abstract of a paper by Bruce Charlton in the Journal ‘Medical Hypotheses.’ It was written in 2008:
‘Zombie science: a sinister consequence of evaluating scientific theories purely on the basis of enlightened self-interest.’
‘Although the classical ideal is that scientific theories are evaluated by a careful teasing-out of their internal logic and external implications, and checking whether these deductions and predictions are in-line-with old and new observations; the fact that so many vague, dumb or incoherent scientific theories are apparently believed by so many scientists for so many years is suggestive that this ideal does not necessarily reflect real world practice.
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.
If this happens, real science expires and a ‘zombie science’ evolves. Zombie science is science that is dead but will not lie down. It keeps twitching and lumbering around so that (from a distance, and with your eyes half-closed) zombie science looks much like the real thing.
But in fact the zombie has no life of its own; it is animated and moved only by the incessant pumping of funds. If zombie science is not scientifically-useable–what is its function? In a nutshell, zombie science is supported because it is useful propaganda to be deployed in arenas such as political rhetoric, public administration, management, public relations, marketing and the mass media generally. It persuades, it constructs taboos, it buttresses some kind of rhetorical attempt to shape mass opinion.
Indeed, zombie science often comes across in the mass media as being more plausible than real science; and it is precisely the superficial face-plausibility which is the sole and sufficient purpose of zombie science.’ 1
Unfortunately, I can only provide you with a reference to the abstract. Because, in what I consider a majestic, universe spanning irony, the full article sits behind a paywall. Nowadays most medical papers are kept safe from the public, or the amateur researchers, or anyone else who is not a millionaire. They can only be viewed by those who have access via their university – usually. I call it ‘censorship by inability to pay.’
You cannot even read medical research that will have been funded by your taxes, or someone else’s taxes in another country. Instead, it sits in a virtual room, secured behind the locked-doors of ‘pay per view.’ Which represents another twitching limb of zombie science. It senses money and reaches out blindly to grab it, with dead, bony fingers. ‘My precious.’
Going back a couple of steps. Who is this Bruce Charlton of whom you speak? Well, he used to edit the journal Medical Hypotheses. But he made the error of publishing an article highly critical of the mainstream narrative on HIV. The article in question contained this statement. ‘There is as yet no proof that HIV causes AIDS.’ Inevitably, a major outcry took place. Glasses of Dom Perignon slipped from chubby, quivering fingers. Foie gras was left uneaten, that and the guinea fowl.
Many will strongly believe, that this statement, and the entire article, must be wrong, and should never have been published. But I would contend that this is absolutely not the point. The point is that anyone who believes articles should not be published because they are ‘clearly wrong’ needs to be gently led away from the world of science. Then booted out of the door and told, in no uncertain terms, to get out and stay out. Until they learn the error of their ways.
‘In science, the primary duty of ideas is to be useful and interesting even more than to be true.’ Wilfred Trotter.
What happened next was depressingly predictable. Elsevier, the publishers of Medical Hypotheses, did exactly what you would expect of the walking dead. They did not defend the right of the editor – of a journal titled ‘Medical Hypotheses’ – to publish contentious articles. They panicked, then piled the blame on Bruce Charlton.
After receiving a raft of complaints, Elsevier had the article peer reviewed under the oversight of editors from The Lancet. Following the peer review, the article, and another by Marco Ruggiero of the University of Florence in Italy, was withdrawn and a reform of the journal was mooted.
“They were withdrawn because of concerns expressed by the scientific community about the quality of the articles, and our concern that the papers could potentially be damaging to global public health,” the publisher said in a statement.’ 2
My favourite comment is below:
‘This journal has published ‘hypotheses’ that are regrettable…“I do not think that the medical community will lose anything if the journal does not continue in its current form.’
And if you want to find a more Stalinist, Big Brother(ist), and frankly sinister comment than the final one, you will need to travel far. ‘Regrettable’ … a word most commonly used by the evil baddie in a James Bond movie. Just before feeding his underling to the sharks waiting below.
Evil bad guy: ‘Your actions, I am afraid, are regrettable.’ Presses button.
And lo it came to pass that Bruce Charlton was fired. Then, in an even more majestic, metaverse spanning irony, Elsevier decreed that the journal Medical Hypotheses must become peer-reviewed. Bruce Charlton had vehemently disagreed to this – another reason why he was fired.
Yes, a journal dedicated to publishing new scientific thinking was to be peer-reviewed. But who could they choose to carry out such a task? All those ‘peers’ who just happened to have previously published the exact same new hypotheses – never published before. A clever trick you may think.
Of course, they do not mean that. What they mean is that established figures within the field should be chosen to do the hatchet job … sorry, peer-review. The very people who would suffer the greatest reputational (and financial) damage, if their established views were to be successfully overturned. Now let me think about the likely outcome of any such review … for approximately one picosecond.
The simple fact is that peer-review has become a slaughtering field for new ideas, and new hypotheses. It is the perfect place to send a timid new-born hypothesis blinking into the sunlight. I visualise a David Attenborough documentary. The bit where a baby wildebeest plops to the ground, under the baleful watching gaze of a pack of hyenas. You know what happens next. It ain’t pretty.
Do you think my view of peer-review is a bit over the top, a wild conspiracy theory of some kind? Well, here is what Richard Horton, long-time editor of the Lancet, has to say of peer-review.
‘The mistake, of course, is to have thought that peer review was any more than a crude means of discovering the acceptability — not the validity — of a new finding. Editors and scientists alike insist on the pivotal importance of peer review. We portray peer review to the public as a quasi-sacred process that helps to make science our most objective truth teller. But we know that the system of peer review is biased, unjust, unaccountable, incomplete, easily fixed, often insulting, usually ignorant, occasionally foolish, and frequently wrong.’
Or this quote from Richard Smith, discussing Drummond Rennie:
‘If peer review was a drug it would never be allowed onto the market,’ says Drummond Rennie, deputy editor of the Journal Of the American Medical Association and intellectual father of the international congresses of peer review that have been held every four years since 1989. Peer review would not get onto the market because we have no convincing evidence of its benefits but a lot of evidence of its flaws.’ 3
Listen guys, sorry to disillusion you, but peer-review was never meant to push forward the boundaries of scientific research. It was primarily designed to keep the top guys at the top, and squash anyone with dissenting views. You think not? You think it has been proven to be effective?
‘Multiple studies have shown how if several authors are asked to review a paper, their agreement on whether it should be published is little higher than would be expected by chance. A study in Brain evaluated reviews sent to two neuroscience journals and to two neuroscience meetings. The journals each used two reviewers, but one of the meetings used 16 reviewers while the other used 14. With one of the journals the agreement among the journals was no better than chance while with the other it was slightly higher. For the meetings the variance in the decision to publish was 80 to 90% accounted for by the difference in opinions of the reviewersand only 10 to 20% by the content of the abstract submitted.’4
And yes, since you ask, I have been asked to peer-review papers. I sent one off recently. Hypocrite? Well, hypocrisy makes the world go around. In my defence I believe it’s a good idea for me to recommend that a ‘contentious’ paper on LDL gets published. Otherwise, my sworn enemies get to clamp it within their pitiless jaws and crush it to death. Why do you suppose I get sent papers from time to time? Because the editor knows exactly what I think, and wants the paper published. Hypocrisy! Why, yes.
In reality, peer-review is about as much use as a chocolate teapot. All journal editors know it’s bollocks, most reviewers know it’s bollocks. But it suits everyone to pretend that the ‘all hallowed’ peer-review cleaves the sword of truth in a mighty fist, protecting us all from bad science.
Does it? Just to give you one recent example where you can replace the words ‘peer-review’, with the words ‘chocolate teapot’ I refer you back to the world of COVID19. Where one, now infamous paper, passed straight through the editorial team, peer-review, and every other check and balance, to find itself published in the Lancet, no less. Even though it rested on completely made-up data:
‘The Lancet will alter its peer review process following the retraction of a paper that cited suspect data linking the controversial drug hydroxychloroquine to increased COVID-19 deaths.
In the future, both peer reviewers and authors will need to provide statements giving assurances on the integrity of data and methods in the paper, the journal’s editor Richard Horton told POLITICO.
“We’re going to ask our reviewers more directly, whether they think there are any issues of research integrity in the paper,” he said. This stipulation will apply to every paper submitted to the journal.
“If the answer to that question is yes, that’s the moment where we trigger some kind of data review,” he added.
These changes to the eminent U.K. journal’s peer review policies are a direct result of a paper that used data from the U.S.-based firm Surgisphere, purporting to be from around 700 hospitals in six continents. But as questions emerged over the study, Surgisphere refused to allow a review of its dataset.
It wasn’t just the Lancet paper that had used data from Surgisphere. The New England Journal of Medicine had used the data for a paper.
The paper was retracted at the request of three of its four authors. They claimed that they couldn’t see the raw data because the fourth author — Sapan Desai, the CEO of Surgisphere — refused to hand it over. But the fact that the co-authors hadn’t seen the raw data pre-publication also raised questions for many readers.’ 5
Yes, indeed, the great and mighty Lancet published a paper based on completely fabricated research. Do you think Horton’s sticking plaster solution is going to have the slightest effect? “We’re going to ask our reviewers more directly, whether they think there are any issues of research integrity in the paper.
Yup, that’ll sort everything out, no doubt about it. No … doubt … about … it. Ask a few peer-reviewers to accuse their peers of potential research fraud. I can see no problem with doing that, at all. I can just imagine the frosty silence that will ensue the next time the author and peer-reviewer meet up.
Peer-reviewer: ‘You’re a liar.’
Researcher: ‘No, you’re a bloody liar.’
Hands up those who think that Richard Horton was simply attempting to deflect criticism away from himself, towards the peer-reviewers. ‘It’s not my fault, it was the peer-reviewers. They made me do it.’ Boo hoo. Poor little you.
Some may believe (as would I dear reader) that this utterly fraudulent load of crap sailed through editorial control, and the peer-review process, because it was attacking the use of hydroxychloroquine in COVID19. Claiming that it killed people. Of course, this was very much the party line at the time. Still is. [Not getting into that debate here].
However, I know, and you know, and everybody knows – although those at the top of this particular game would deny it vehemently – that if the authors had claimed the opposite well then. Well then… well then, their research paper would have been scrutinised to within an inch of its life, then rejected. On whatever grounds could possibly be found. A semi;colon in the wrong place. ‘Off with their heads.’
Peer-review. Yes, peer-review… a crude means of discovering the acceptability — not the validity — of a new finding.
Max Plank was the man who published Albert Einstein’s special theory of relativity. Much against forceful dismissals by his peers it must be said. Einstein’s theory was, at the time, very much unacceptable to most physicists. Plank held out against them, which was perhaps to be expected. He was a bit of a free-thinker. As he once famously said:
‘A new scientific truth does not triumph by convincing its opponents and making them see the light, but rather because its opponents eventually die, and a new generation grows up that is familiar with it.’
Science can never be about acceptability – which is, too often, the purpose of peer-review. It is about the truth. Or reality, or whatever term is the best description to use. Science is about rocking the boat, and upsetting the established views, and informing ‘experts’ that they are talking rubbish.
As Richard Feynman said. ‘Science is the belief in the ignorance of experts.’
Peer-review achieves the exact opposite of what we should want from science. It cements the power of experts. It acts as a brake on progress. It rewards those who maintain the status-quo. It helps to ensure that acceptable papers are published, and unacceptable papers are not.
Yes, I am fully aware that the vast majority of people use the term ‘peer-reviewed’ as a term of praise. A stamp of scientific veracity. It has the exact opposite effect on me. It grates horribly. Just publish the damned paper and let me decide if it is a load of rubbish, or not, thank you very much. I do NOT need a board of censors to decide what I can and cannot see. Lest my poor little unformed and childish mind becomes corrupted.
I also know, I really do know that we would all love to believe in peer-review. Surely it is better than doing nothing. We cannot just let any old crap get published, can we? To be perfectly frank, the idea that we have to do something, simply because we believe something must be done, is an insatiable human drive that is another of my pet hates.
A.N. Idiot: ‘Something must be done.’
A.N. Other Idiot: ‘Here’s something, let’s do that.’
Me: Sigh. ‘With or without any evidence that it works?’
Further Idiot: ‘Evidence, we don’t need evidence. It is obvious that this will be effective.’
All idiots together: ‘Well, that’s good enough for me.’
Here is the contrary standpoint. If doing nothing is just as effective as doing something, then I always recommend we take the ‘doing nothing’ option. Apart from anything else it frees up time to do other things that are clearly more beneficial. Such as getting in a bit of whisky tasting or picking your teeth.
In fact, doing nothing is part of my broader ‘don’t just do something, stand there’ initiative. Unfortunately, almost everyone else seems to favour the ‘Work, work, busy, busy, chop, chop, bang, bang.’ philosophy. ‘Looks how busy I am. I must be doing good.’ To quote Bing Crosby:
‘We’re busy doin’ nothin’
Workin’ the whole day through
Tryin’ to find lots of things not to do
We’re busy goin’ nowhere
Isn’t it just a crime
We’d like to be unhappy, but
We never do have the time
I have to watch the river
To see that it doesn’t stop
And stick around the rosebuds
So they’ll know when to pop
And keep the crickets cheerful
They’re really a solemn bunch
Hustle, bustle
And only an hour for lunch.’
I love that song.
Having said this, I also do believe we should try to ensure that research papers are not complete rubbish, based on fraudulent research (see under the Surgisphere paper on hydroxychloroquine – published in the Lancet). For science to work, we should be able trust what we read. As far as this is possible.
But the peer-review system, as it currently exists, does not achieve this. It allows utter made-up rubbish to be published. Worse, much worse, it stops a great deal of potentially valuable research dead in its tracks.
‘If mankind is to profit freely from the small and sporadic crop of the heroically gifted it produces, it will have to cultivate the delicate art of handling ideas.’ Wilfred Trotter.
Therefore, gentle reader, I have a suggestion. Journal editors should make their own decisions about what should and should not be published, based on how interesting and valuable it seems, then publish. Do not hide behind shadowy peer-reviewers, who have their own agendas to pursue.
At which point you use the Internet for what it is good at. Get a bloody good discussion going. Make the article free to view, for anyone, for the first two or three months – or longer. Invite a broad scientific audience to get involved.
Make it easy for people to attack it or praise it. Hit the upvote button. There are very many, very smart people out there. If they can’t find a problem with a paper, fine. If they can, get the authors to argue their case. Publish the best responses. Expose the discussion to the world. Pull the paper, if needed. Slap various addendums on it, such as ‘readers should note that this paper is a steaming pile of…’
Would this work. Well, it was certainly not the Lancet editorial team, or the peer-reviewers, or even the authors of the paper, who recognised that the hydroxychloroquine paper was fraudulent. It was other researchers from around the world who pointed out that the data were made-up.6
So, in my view, we need to allow the entire world to be reviewers and get rid of peer-review. Other than use it to provide helpful suggestions as to how to make the paper better. Just to add that the helpful elf who edits my blog ramblings, had this to say about this blog:
‘Like it – what you’re suggesting is a TripAdvisor like free scientific paper web site that can be commented on by anyone … ‘ Which is a bloody good summary.
I lay this suggestion before you with all great humility. Next, I hope to discuss the FDA, and the other regulatory bodies around the world. Let me see. What comes after hyenas? Vultures, great white sharks, vampires, leeches … let me think.
Ivor Cummins and me, and our part in Big Pharma’s downfall…
Ivor Cummins and Mark Felsted are running another conference looking at the causes of cardiovascular disease. I shall be speaking and presenting a few more thoughts. For example, why has the rate of CVD shot up in the last eighteen months? Possibly explanations? I hope you can attend, and you will all hopefully learn something new, and help us in our endless quest to derail the big pharma leviathan – or perhaps scratch the wing mirrors slightly.
[How fewer doctors means more doctors – it’s official]
This blog has nothing to do with heart disease, or vaccines, or anything directly about medical practice at all.
However, it does have a great deal to do with data manipulation, which is something very close to my heart. It also illustrates how a ‘fact’ can be anything but.
I am also hoping to help highlight an increasingly worrying trend that now scours the planet. Namely that we are living in a world distorted to fit whatever narrative those in power are trying to stuff down our throats. Although, I continue to marvel at how anyone can spout utter, utter, nonsense, and not simply curl-up and die of acute embarrassment.
Anyway, gentle reader, let me set the scene for your delectation.
In the UK, more specifically England, doctors and nurses have been leaving the profession in droves. In particular GPs. This has caused a degree of faux concern by politicians, who always wish to claim they are the great protectors of the NHS. The NHS is inevitably a big issue at every election.
Years ago, Jeremy Hunt, the then health secretary – and slippery eel made flesh – promised he would ensure there would be five thousand more GPs within about five years(ish). The actual number of years it was going to take kept moving around as the target receded into the distance. ‘Did I say three, I meant five… or was it ten.’
Commentary on this was not complementary:
“Delivering 5,000 extra GPs in five years, when training a GP takes 10 years, was a practical impossibility that was never going to be achieved,” said Dr Chaand Nagpaul, chair of the BMA’s GPs committee.
“It was a pledge that also ignored the fact that one third of GPs are planning to retire by 2020, and the current medical graduates do not want to join an overworked, underfunded service, with more than 400 GP trainee posts left unfilled last year.”
Andrew Gwynne, the shadow health minister, said Hunt was backtracking on the pledge, and that “the Tories’ election promises are unravelling one by one”.1
Seven years, or so, have now passed since Hunt’s promise, and the number of GPs has fallen. As predicted by anyone who knew why GPs were leaving. Basically, they were all burnt out, and pissed off, and nothing was being done to make their lives easier, especially, especially not by Jeremy Hunt – who did nothing but make the job considerably more difficult. I should know, I am one. Both burnt out, and pissed off, but clinging on – for increasingly unfathomable reasons. Money, mainly.
Now, however, the UK has a new Prime Minister, a new cabinet, a new health minister and a new Chancellor of the Exchequer (one Jeremy Hunt, no less). Lo and behold, we find that the number of doctors and nurses has actually, mysteriously, who’d have thunk it … increased. Even GP numbers have increased!
‘Latest data published by NHS Digital shows that, compared to August 2021, there are also over 3,700 more doctors and over 9,100 more nurses working in the NHS.
Secretary of State for Health and Social Care Steve Barclay* said:
More healthcare staff means better care for patients, which is why it’s fantastic to see a record number of over 1.2 million staff working hard in the NHS.
With over 3,700 more doctors and 9,100 more nurses, we are really putting patients first and NHS England is developing a long-term workforce plan so we can continue to recruit and retain more NHS staff.
Thanks to all our doctors, nurses and NHS healthcare staff who work tirelessly to look after us and our loved ones and continue to inspire future generations to join this rewarding career.
The government continues to deliver on its commitment to recruit 50,000 more nurses by 2024, with 29,000 more nurses since September 2019.’ 2
[*this is a new, new, health secretary. The previous new one, began this sorry saga]
Phew, all is well. Sorted. What a remarkable thing. How has this been achieved … virtually overnight? Did they manage to compress the average training time for a fully qualified doctor from at least ten years to one month? Did they find a locked room full of 3,700 doctors and 9,100 nurses that no-one had noticed before? ‘You are now free to leave and start working. Go, go now, and tend to the sick.’
No, to understand where these figures come from, let us go back in time. Twenty-nine days from the date I wrote this blog – to be exact. We shall visit a website known as doctors.net. A place where doctors post about various things – but nothing critical of vaccines obviously. Here, twenty-nine days ago, we find this, possibly, strange post:
‘I’ve just had an email from the GMC saying the secretary of state has asked for my emergency registration to run until 2024. I doubt she had me in mind specifically. I wonder what has been foretold?’
And this one:
‘Oh. My wife tells me she has also been re-registered.’
And this one, amongst many others:
‘I’ve had the email too. They’ve also apparently restored emergency registration for the nurses, too; just after some of the ones I was working with at the vaccination centre paid to continue their registration. They are somewhat pissed off.’
What is this emergency registration of which they speak? Well, during the COVID19 panic, sorry pandemic, a number of doctors and nurses who had recently retired, (and who had handed back their registration) were unceremoniously dragged back onto the register. Thus, allowing them to keep on practicing medicine. Whether they wanted to or not … most didn’t.
These doctors and nurses didn’t need to do anything themselves, not even ask to be re-instated. It was just done. This policy was designed to help plug holes in staffing. It was known as emergency registration. As stated here, with regard to nurses:
‘The Coronavirus Act 2020 gives the Registrar a new emergency power to temporarily register a person or group of persons as registered nurses, midwives or nursing associates if the Secretary of State advises that an emergency has occurred, is occurring or is about to occur.’3
Then as the panic, sorry pandemic, fell away, emergency registrations began to be withdrawn.
‘Many temporary Coronavirus Act provisions remain in force. However, by default they will expire on 25 March 2022. The Government has said it will allow almost all these provisions to expire.
The following policy areas have temporary changes which are set to expire in England or (where relevant) on a UK-wide basis:
– temporary registration of health and social care professionals’ 4
Of course, getting rid of emergency registration would have the effect of (appearing to) sharply reduce the number of doctors and nurses. Even if the vast majority of those who had been plonked on the register never did an extra day’s work and remained happily retired. Yes, this was always a ‘pretend’ workforce. ‘Look at all these additional doctors and nurses we have created… who we haven’t spoken to, and we have no idea if they will ever work again …’
Anyway, the Government was dispensing with emergency registration. Then, out of the blue, it was back again. With retired doctors and nurses placed back on the ‘pretend’ doctors and nurse’s lists once more – until 2024. Which just happens to be the year of the next general election.
What is the explanation for this? Well, according to the General Medical Council in September 2022:
‘The UK government asked us to give temporary emergency registration to suitable people, as part of the response to the coronavirus (COVID-19) pandemic.’ 5
[The General Medical Council (GMC) controls medical registration].
What…? We had a new COVID-19 pandemic last month? I thought it started in 2020. Did you know it was back with a vengeance? Did you? Did you hear anything about it? No, you didn’t, because it never happened. This statement is simply … not true. I would never dream of calling it a damned lie. Other’s may feel differently.
Anyway, let me take you through this from a slightly different angle.
The UK Government is desperately trying to claim they are doing everything they can to support the NHS, which is currently falling to bits, and will damage their prospects at the next election. One of the key things they wish to claim is that they are increasing the work force – especially doctors and nurses (not managers for some strange reason). However, …
‘More than 40,000 nurses have left the NHS in England in the past year, an analysis by the Nuffield Trust has revealed.
The analysis, conducted by the think tank for the BBC, said that this is the highest number and proportion of nurses leaving the NHS since trend data began.
It found that many of these nurses were often highly skilled and knowledgeable with many more years of work left.’6
In addition:
‘Over the last year, the NHS has lost 339 individual (headcount) GP partners and 305 salaried, locum and retainer GPs. This has created a net loss of 644 individual GPs since September 2021…There are now just 0.44 fully qualified GPs per 1,000 patients in England – down from 0.52 in 2015.’7
Yet, despite all these people heading for the exit, the Government now informs us that the workforce is not falling, it is going up, up, up, baby. I find this apparent conundrum to be spookily similar to my findings when studying research papers. How can various results be reconciled, when they seem directly contradictory? Heart attacks fell, but deaths from heart disease increased. In the same trial? Oh no, I must read the methodology section – usually impenetrable.
In the same way, we find the number of ‘registered’ doctors is going up, whilst the number of doctors is falling. This leaves us with two seemingly contradictory facts. Which of them is true? Or can they both be true?
In my simple little world, the true ‘fact’ is that the number of doctors is falling, rapidly. However, the Government have solved this issue by creating an equal and opposite fact. Which is that the number of doctors is going up.
They achieved this remarkable feat by bringing back the emergency re-registration of retired doctors, sharply increasing ‘pretend’ doctor’s numbers. In this weird, distorted, manipulated way we have another’ fact’ on our hands. Which is that there are more doctors on the register a.k.a. ‘more doctors.’
Which of these facts is true? Yes, in the hands of politicians, facts can become slippery little swine.
To quote John Martyn: ‘Half the lies I tell you are not true.’
In truth, once you cut through the utter steaming bullshit, I know, and you now know, what is going on – as did many doctors at the time. Here are a few more posts, from twenty-nine days ago, commenting on the re-introduction of emergency registration:
‘After a few hours to consider, I have now emailed the GMC to ask that my temporary registration be removed. FWIW (for what it is worth) I think it highly likely that this is an attempt by the government to inflate the apparent numbers of doctors available.’
Or this one:
‘It has been foretold that for purposes of political spin, they need to say that they have more doctors on the register.’
Another doctor was even more acute in their observation – twenty-nine days ago:
‘The weird thing about this is the clear and direct nature of cheating.
If – as is highly likely – this process relates to absolutely nothing at all apart from manipulating stats to misrepresent reality for political ambitions, then there would be people with job time allocated to it, meetings, emails, conclusions, notes, presentations etc.
“Are you going to the meeting about cheating the doctor numbers tomorrow?”
“Yes, I should make that meeting where we deliberately lie about how many doctors there are”
“Great, see you there. Hopefully we can cheat those figures really efficiently and get away on time!”
And lo, the game played out, exactly as predicted. One month ago, the Government very deliberately inflated figures on doctor’s numbers (and nurse’s numbers). Now they are crowing, in public, about this magnificent increase. ‘Look how brilliant we are. ‘
‘Crikey, how did you manage this totes amazeballs thing?’
‘Well, wouldn’t like to boast about it, really. Hard work, dedication … I would like to thank my team. Golly, is that the time, must dash.’
Do they think we are all completely stupid? Don’t answer that, they clearly do. Do they think no-one noticed? People were tweeting about it at the time:
‘Why has Secretary of State for Health and Social Care @theresecoffey asked the GMC @gmcuk to extend temporary registrations until 2024? Is this to prevent a sudden drop in the number of doctors on the register, causing embarrassing stats in the press?’ 8
Today, we are swimming in a sea of misinformation, and deliberately manipulated statistics. Yet, people seem to shrug their shoulders. ‘Don’t get worked up about it. Everyone is up to it, who cares. Same old, same old. The other lot are just as bad.’
It is time, I believe, for pitchforks and burning torches, and people taking to the streets in protest about the way that this world is going. So very badly wrong.
‘In a time of deceit telling the truth is a revolutionary act.’ George Orwell.
I have been somewhat quiet recently. I have started about ten blogs, then got bogged down …. possibly blogged down? Then stopped, and started again, then tore it all up – metaphorically.
The problem is that I have been looking at COVID19 vaccination.
There is much to say, maybe too much. However, one treads a very fine line here. I liken it to walking along a cliffside, in the dark. At any point you can make a small mis-step and plummet to your doom. Or, perhaps it is more like being in the trenches in World War I, knowing that at any point, a sniper could pick you off.
Yes, it is true that WordPress doesn’t seem to care much what anyone writes. Good for them, I say. So, I can write pretty much whatever I want. But the rest of the world watches, waiting for the slightest mistake. At which point you shall be denounced, then silenced, in all other outlets. If this happens, the vast majority of people stop listening to you. ‘Oh him, he’s one of those anti-vaxx nutters. Don’t listen to a word he says.’
Yes, I know there is a large community out there who do not follow the mainstream narrative. Those who know there are – or certainly may be – some significant issues with the COVID19 vaccines. In particular the mRNA vaccines. Speaking to them is easy, gaining their support is easy. They cheer you on.
However, there is no real point in reaching out to them, enjoyable though it may be. It is preaching to the converted. The people that I would really like to get at are those who firmly and absolutely believe that mRNA vaccines are highly effective, absolutely safe, and that everyone should be happy to be vaccinated. Along with their children.
The people who are also very critical of those who do not get vaccinated [I have had three doses, but I shall not be having a fourth, unless things change dramatically].
How do you reach these people? How can you even begin to get them listening to anything you have to say?
To give one example of the problem of starting a discussion. I posted a link in a discussion forum on the Doctors.net website (a website that can only be accessed by UK registered doctors). This link discussed some issues with vaccines. It didn’t seem, to me, to be hyper-critical.
However, I got a message from the moderators informing me that if I attached links to any information critical of vaccines, again, they would remove me from the site. This was my final warning. No discussion.
More recently, the post below was published on the same site. It was in response to a twitter comment which followed an interview with Dr Aseem Malhotra:
‘This is a disgraceful interview with this self-publicising charlatan and hypocrite. He says that “until proven otherwise, it is likely that Covid mRNA vaccines played a significant or primary role in all unexplained heart attacks, strokes, cardiac arrhythmias, & heart failure since 2021”.
That is so grossly irresponsible and untrue It staggers me to think he can be allowed to say this and remain a registered medical practitioner.’
The post I have duplicated here was published by a doctor who works, full-time, for a pharmaceutical company. Something he, surprisingly, failed to mention as a potential conflict of interest. Others piled on in support of him. Many of them agreeing that Aseem Malhotra should be flung off the GMC register forthwith – which would render him unable to work as a doctor.
I suggested that, perhaps it would be better to engage Dr Malhotra in debate, rather than attacking him as a charlatan. At which point I was attacked. In my opinion, if you find yourself being attacked for suggesting that it would be a good ideal to have a debate, it is not difficult to work out which way the wind is blowing.
I have discussed vaccination at my local sports club. At which point, almost everyone takes on that silent, arms crossed look, if you mention you have some concerns about vaccines.
They don’t debate the issue, because they can’t, because they don’t know anything other than what they have been told by mainstream media. But it is clear that some of them now see me as a bloody anti-vaxxer. Even if I say nothing more than, ‘I have some concerns.’
Yes, to ask for debate, or to dare express some concerns, is to be labelled an anti-vaxxer.
This is a very high barrier to overcome. I have tried irony. ‘Oh yes, I am absolutely one hundred per cent in favour of COVID19 vaccines. I think everyone should have them four times a year. Pregnant women, children from the moment they are born. No exceptions at all. Yes, these mRNA vaccines have been fully tested. It is clear that they are one hundred per cent safe and one hundred per cent effective. Yup, I cannot see any problems with them at all.’
Response. You are taking the mickey and you are an anti-vaxxer. I claim my prize.
I have also tried saying absolutely nothing at all. I still got accused of being an anti-vaxxer because I did not enthusiastic agree with criticising someone who was believed to be an anti-vaxxer.
Maybe I should just attend this meeting ‘The New Frontier of RNA Nanotherapeutic. Monday, October 24, 2022 8:30 a.m. – 5 p.m. Hybrid Conference’:
‘The RNA vaccines against COVID-19 mark the beginning of a technological revolution that will transform the way we treat disease and restore health. “The New Frontier of RNA Nanotherapeutics” presented by the George and Angelina Kostas Research Center for Cardiovascular Nanomedicine, will feature a discussion on the events that led to the RNA vaccine breakthrough and preview emerging RNA Nanotherapeutics. Advances in the design of RNA constructs to improve stability and translational efficiency will be presented along with the leading-edge developments in nanomedicine to improve delivery and tissue specificity. The potential of nanotechnology-enabled RNA therapeutics to enhance health is virtually limitless.’
Any doubts I have will evaporate …. maybe.
Anyway. The answer as to … how can I even start a discussion on mRNA vaccines without being shot, falling of the edge of cliff, or being silenced, continues to elude me. Farewell enlightenment. Hello dark ages.
Science, to me, is debate. Science is attacking ideas from all directions. No exceptions. Those ideas which cannot be destroyed may turn out to be correct. But, if an idea is considered sacrosanct, with anyone questioning it condemned as an unbeliever, then we do not have science. We have religion. So yes, in my opinion, vaccines, and vaccination, have become a religious belief. No evidence needed.
Scary. Anyway. If anyone has any good ideas about how a debate can even get started, without descending into anger and accusation … please let me know. It seems beyond me. The end.
Once again, saturated fat is found not guilty [yes, once again]
I suppose that what I am about to tell you is pretty much old hat. Many people, including me, have been saying – for many years – that saturated fat has no impact on cardiovascular disease. Never has, never will. The scientific support for it has always been non-existent, and the hypothesis has always been complete fact-free, evidence-free, thought-free, nonsense.
Indeed, it is more likely that saturated fat may have beneficial effects. It certainly does if you replace fat in the diet with carbs, carbs, carbs … and more carbs. Which is what most people have done. Happily following the idiotic advice of nutritional experts around the world.
Anyway, mainly so that I can sit back and say, ‘I told you so’ once again, here is the abstract from a paper that was published in the European Journal of Preventive Cardiology a couple of weeks ago ‘Saturated fat: villain and bogeyman in the development of cardiovascular disease?’1
Key comment – to be found at the end.
‘…there is no scientific ground to demonize SFA as a cause of CVD. SFA naturally occurring in nutrient-dense foods can be safely included in the diet.’
Abstract
Background
Cardiovascular disease (CVD) is the leading global cause of death. For decades, the conventional wisdom has been that the consumption of saturated fat (SFA) undermines cardiovascular health, clogs the arteries, increases risk of CVD and leads to heart attacks. It is timely to investigate whether this claim holds up to scientific scrutiny.
Objectives
The purpose of this paper is to review and discuss recent scientific evidence on the association between dietary SFA and CVD.
Methods
PubMed, Google scholar and Scopus were searched for articles published between 2010 and 2021 on the association between SFA consumption and CVD risk and outcomes. A review was conducted examining observational studies and prospective epidemiologic cohort studies, RCTs, systematic reviews and meta-analyses of observational studies and prospective epidemiologic cohort studies and long-term RCTs.
Results
Collectively, neither observational studies, prospective epidemiologic cohort studies, RCTs, systematic reviews and meta-analyses have conclusively established a significant association between SFA in the diet and subsequent cardiovascular risk and CAD, MI or mortality nor a benefit of reducing dietary SFAs on CVD rick, events and mortality. Beneficial effects of replacement of SFA by polyunsaturated or monounsaturated fat or carbohydrates remain elusive.
Conclusions
Findings from the studies reviewed in this paper indicate that the consumption of SFA is not significantly associated with CVD risk, events or mortality. Based on the scientific evidence, there is no scientific ground to demonize SFA as a cause of CVD. SFA naturally occurring in nutrient-dense foods can be safely included in the diet.
Will this paper have any effect on anything? Will it heck!
Although maybe, just maybe, a few people out there will stop for a moment to ponder the known fact, verily the truth, that saturated fat causes cardiovascular disease. As for the rest …
‘Man will occasionally stumble over the truth, but most of the time he just picks himself up and stumbles on.’ Winston Churchill
Just so I am not accused of sexism. Women do this do too. Please now write out one hundred times:
Saturated fat does not cause cardiovascular disease
Saturated fat does not cause cardiovascular disease
Saturated fat does not cause cardiovascular disease rpt x 97
In my last blog I asked the question. Why did COVID19 lead to a spike in overall mortality in England, but not (or far less so) in Wales, Northern Ireland and Scotland? In a number of age groups, there was no impact on mortality – at all.
The most likely answer, I think, is the proportion of ‘non-white’* people living in each country. England has far more non-white people. Around 18% – it is difficult to be absolutely certain about this figure. In Scotland, Wales and Northern Ireland it is about 4%, maybe even less in Northern Ireland.
This difference could also explain Sweden and Norway. The Norwegians do not publish data on ‘race.’ It is considered racist to do so. Which of course leads to problems in situations like this where you might need the data to help protect those of different races.
So, ironically, it could be considered racist to have no data on different races? Discuss. However, the estimate is that around 3% of the Norwegian population is ‘non-white.’ In Sweden the proportion is very similar to that in England.
Therefore, my working hypothesis is that non-white people living in countries at a high latitude, are significantly more likely to be vitamin D deficient.
‘Non-white populations in Europe are at higher risk of vitamin D deficiency than their white counterparts. For example, compared with white populations in the United Kingdom, Norway, and Finland, the non-white population subgroups have 3- to 71-fold higher yearly prevalence of vitamin D deficiency.’1
Vitamin D deficiency increases the risk of mortality from COVID19:
‘The all-cause 30-day mortality was 13.8% in the group of patients with sufficient plasma 25(OH)D levels and 32.1% among those with deficient plasma 25(OH)D levels. Cox regression showed that plasma 25(OH)D levels remained a significant predictor of mortality even after adjusting for the covariates sex, age, length of the delay between symptom onset and hospitalization, and disease severity.
Conclusion
Vitamin D deficiency predicts higher mortality risk in adults with COVID-19’ 2
The ratio between 13.8% and 32.1% is 2.3. Which is big.
A number of people suggested race, and vitamin D, as a possibly hypothesis. I agree with them. Now, what are we going to do about it …before winter arrives that is. I recommend several thousand units of vitamin D each day, until March.
I recommend this for everyone.
I would like to reinforce this, because other studies have shown that giving people Vitamin D, once they are infected, does nothing. It is too late. So, start now. In this case prevention truly is better than (no) cure.
*I use the term non-white as it appears to be most acceptable way of describing those who are not, genetically, native to countries such as England. I do realise that whatever term is used to try and describe ‘racial difference’ some people will be offended. This is the reason why the term BAME: black, Asian and minority ethic is not being used anymore (Please be assured that I mean no offence).
Some of you may remember COVID19. We had an epidemic, or a pandemic, or … choose whatever word you like best. The legacy of it still hangs about in many strange, disconnected actions.
My last flight in late August, on Lufthansa, required me to wear a mask. The connecting flight with Swissair, did not. No mask was required whilst waiting at Munich airport or being transported to and from the planes in a crowded bus. Go figure. I am sure this all makes sense to someone, somewhere.
Anyway, I thought it might be good time to have a catch up and see if we can learn anything more about the pandemic and the drastic actions taken to control it. The first thing to say is that this is a complex task. Mainly because the data surrounding COVID19 are unreliable. To say the least.
How many people have been infected with Sars-Cov2? How many have died? I believe we can only really guess. Worldometer, as of the tenth of September 2022, confidently informed me there have been around six hundred million people infected with COVID19 worldwide (613,234,326). The number of deaths is just over six million (6,514,989)1.
Quite remarkably, this represents infection fatality rate of pretty much bang on one per cent. As predicted by Imperial College London and Professor Neill Ferguson. Take a bow that man? Or perhaps not. How many people think that those figures are remotely accurate? Certainly not me. Just to start with, do we really believe that ninety per cent of people have managed to avoid a Sars-Cov2 infection?
My own belief is that virtually everyone in the world has been exposed to/infected by Sars-Cov2 and at least once. (The concept of what ‘infection’ means has undergone a bit of a transformation, a.k.a. mangling). We already know many people have been infected several times. In fact, as early as the autumn of 2020, doctors were seeing people who had been, proven, to be infected twice. Even then, these cases were considered to be the tip of the iceberg.2
If people were getting infected twice, within six months of the virus arriving, I think we can safely assume almost everyone else has been infected at least once. Maybe a few villagers in the Amazonian rain forest have remained exposure, and infection, free. As for everyone else… unlikely.
And as for the numbers of COVID19 deaths, again, can we know anything for certain? I wrote out four death certificates which included COVID19 as a cause. This was early on, before much testing was possible. I have no idea if they had COVID19, or not. I cannot imagine I was alone in adding to the COVID19 stats, whilst blundering around in the dark.
If we can’t really rely on these, the most basic of facts, then can we learn anything? I think so, I hope so. Indeed, from the very start I tended to focus my attention away from COVID19 specific data, towards data I felt I could trust. Namely, the overall mortality rate.
Although these data do not allow us to be certain who died of COVID19, the numbers are the most robust we have. Someone is either alive, or dead, and it is difficult to get the diagnosis wrong. Yes, there can be some delays in reporting etc. but in general dead is dead and alive is alive, and that is that. One hundred per cent accurate.
Of course, in order to use these figures, I have to make assumption (made by many others), that spikes in overall mortality would be the best way to get a fix on how many people COVID19 was actually killing. A big spike – more deaths from COVID19. No spike, no extra deaths from COVID19 (or very few).
So, did every country show pretty much the same pattern in mortality? Or were there extremes or outliers? I am a believer that it is at the extremes where answers can often be found.
I began by looking for countries – or populations within those countries – that suffered a major increase in overall mortality. Then I looked for matching countries, and populations, that showed no change, or very little change. Because here, maybe, we could find some solid ground to stand on.
The most easily accessed data can be found at EuroMOMO3. This is a resource where data on overall mortality are collated from many different European countries. The site then plots mortality against a (moving) five-year average.
I ended up focussing on European data, not just because it was easy to find, but mainly because most European countries are very similar in many important parameters. Standard of living, health service provision, demographics, life expectancy and suchlike. Which means that you are comparing like with like. Try to compare Norway with, say, Kenya, and you end up with a mess.
On the other hand, you can more reasonably compare Norway and Sweden. There are far fewer differences between them, which should make it simpler to spot the key one(s).
However, to start with I am not going to look at Norway and Sweden. Instead. I want to draw your attention to four countries that are not, in truth, separate countries. They are Scotland, England, Wales and Northern Ireland. Four different ‘parts’ that make up the single entity known as ‘The United Kingdom of Great Britain and Northern Ireland’. Longest country name in the world – good pub quiz question.
It is true these four ‘countries’ did not do precisely the same things during lockdown. But the differences in timings and actions, were small – with a few (look at me, I’m locking down harder than anyone else, vote for me … thank you Nicola) variants. However, you will struggle to find any other four countries that were more alike in their characteristics and actions.
Despite their many similarities, one of these populations showed a hugely significant increase in overall mortality, and the other three did not. This difference can be seen most starkly within the age group of forty-five to sixty-four.
First, a short explanation of what you can see in the graphs below.
The – somewhat difficult to make out – dotted line represents the rate of overall mortality five standard deviations above the norm for the time of year. Mortality is always higher in winter than summer, but these graphs take this into account, and are mathematically flattened out.
The darker, spiky line represents the overall mortality rate. If it rises above the dotted line this is considered to be a ‘statistically significant’ event. Or, to put it another way, something is happening that is killing far more people than we would expect to see, and we need to find out what. This is normally due an infectious disease of some kind, almost always influenza.
The scale on the left -10, 0, 10, 20 is not an absolute figure. It represents the standard deviation from the mean (the z score). If it goes above ten, this is big time trouble. Above twenty, look out, the sky is falling. In general, two standard deviations from the mean is considered ‘statistically significant’ in medical research.
OVERALL MORTALITY RATES AGE 45- 64 IN THE UNITED KINGDOM 2017 TO SEPT 2022
As you can see. England had a three major mortality ‘peaks’. Spring 2020. Winter 2020/21 and a far more diffuse mountain range in autumn and winter 2021. The other three countries showed almost nothing at all.
I will just add in here that the difference is not restricted to this one age group. Below is a graph of the sixty-five to seventy-four-year-olds.
OVERALL MORTALITY RATES AGE 65 to 74 IN THE UNITED KINGDOM 2017 TO SEPT 2022
Pretty much the same pattern emerges. Two massive upticks in overall mortality in England, very little elsewhere. Absolutely nothing to see in Northern Ireland. If COVID19 was killing lots of people in Northern Ireland, it was not showing up.
First question, does England have a worse health service than the other three countries? No, it does not. Is the overall health worse in England? Well, in general, the English have a longer life expectancy than those in the other three countries, rather than the other way around. Which suggests that the English are, in general, healthier 4.
What was the same in these countries
The health services
The age of those dying (I matched people for age)
The lockdowns (very minor differences)
The treatments given
The vaccinations given
The climate
Overall life expectancy (very minor differences, should be favouring England)
So, what was different?
Over to you. Because if we can work out what caused all these people to die in England, and not in Scotland, Wales and Northern Ireland, we can probably learn something of great value.
Before that – and changing tack for a moment or two, in the early days of COVID19, everyone jumped around claiming that Norway had done things fantastically well, as they had no change in overall mortality, and very few recorded COVID19 deaths. ‘Look at them shutting their borders and enforcing a very tight lock-down. Way to go whoop, whoop.’
No-one bothered to mention Northern Ireland. Which did precisely the same as England. Yet also had no change in overall mortality, as per Norway. You could argue that Northern Ireland did not fit the agreed narrative, whereas Norway did.
Sweden, on the other hand, famously did not lock down, ‘shock-horror, everyone in charge should be fired, or thrown in jail’. Sweden did have significant uptick in overall mortality. Proof that lock-downs were essential?
Possibly … probably not. Many other countries in Europe which did lock down, have had far more COVID19 deaths, and a greater impact on overall mortality, than Sweden.
Here are the European countries that have recorded more COVID19 deaths, per head of population, than Sweden. In descending order1:
Bulgaria
Bosnia and Herzegovina
Hungary
North Macedonia
Georgia
Croatia
Czechia
Slovakia
Romania
Lithuania
San Marino
Slovenia
Latvia
Gibraltar
Greece
Poland
Moldova
Italy
Armenia
Belgium
UK
Russia
Ukraine
Portugal
Spain
France
Liechtenstein
Austria
Estonia
Andorra
SWEDEN
Here, I did use COVID19 deaths, as reported on Worldometer – with all caveats recognised. The reason for using these figures rather than overall mortality, is that they were, initially, used to attack, the Swedish response. [People are a lot quieter about Sweden now] Also, calculating the overall mortality increases in these countries represents a very major task – with complex adjustments to be made. So, I didn’t do it here. I would also point out, for the sake of completeness, that Sweden is reported to have had 1,968 COVID19 deaths per one million of the population. Norway 728. [Two per thousand vs. point seven per thousand]
Lithuania, by the way, like Norway, is very similar to Sweden. For about a hundred years they ruled central Europe together within the Union of Kedainiai. In many ways, they have more in common than Sweden and Norway. It should be noted that Lithuania locked down early, and hard. You may note Lithuania pops up at number ten in the list above. Reported COVID19 death rate 3,528 per million.
You may disagree with my definition of European country … Gibraltar? Listen, I got this from Worldometer, so you can fight with them. However, if anyone wishes to tell me that Sweden suffered a unique catastrophe due to their reluctance to fully lock down, they may struggle to convince me that it was the critical factor. In fact, I may give a hollow laugh, even raise a quizzical eyebrow.
So, what else was different between Norway and Sweden? Something that could reasonably explain the difference in both recorded COVID19 deaths, and overall mortality. I believe there is another clue within the EuroMOMO data. If you choose to look at what you are actually seeing.
Below are the data from Norway from late 2017 (slightly annoyingly, their data only started in late 2017).
OVERALL MORTALITY NORWAY LATE 2017 TO 2022 – all ages
What stands out very clearly is that the Norwegian overall mortality rate has never spiked. At least not since late 2017… on EuroMOMO. This was even the case in the winter of 2018, which was a bad flu season across most of Europe. Something that shows up most clearly in Germany, although the same pattern can also be seen, to a lesser extent, in France, Belgium, Austria, the Netherlands, UK, Portugal, Italy etc.
OVERALL MORTALITY GERMANY 2017 TO 2022 – all ages
Did the Norwegians lock down in 2018. No, they did not. So, what stopped them dying from flu? The answer is … something else. And that something may well be the same thing that stopped them dying of COVID19.
As an aside, why did the Germans not panic in 2018, when more people were dying then, than from COVID19 in 2021? They had a z-score of very nearly twenty. Did anyone even notice? Was it front page headlines? No, of course not. It passed in virtual silence. Compare and contrast, as they say.
Anyway, I hope that I have given you a little puzzle to solve. I have been contemplating this puzzle for some time, and I think I may have identified the key factor that can explain the patterns in the UK, and also between Norway and Sweden. I am interested to see what other people’s thoughts might be.
Before coming back with answers. Remember, these data are age-matched. They compare overall mortality, not the number of recorded deaths from COVID19. They are not the absolute numbers of deaths, but variation from the mean. The z-score.
And so, after a great deal of faffing about, my article on cardiovascular disease ‘Assessing cardiovascular disease: looking beyond cholesterol’ has been made free to view.
Writing an article for a medical journal is not that difficult. Trying to submit it through Kafkaesque editorial systems, now, that is tricky. They seem incapable of understanding that I am not funded by anyone. Shock, horror, I do it simply for the love of science – or something of the sort.
As for allowing the article to be open access … don’t go there. I would rather fill in a US tax form, in triplicate and, yes, I have seen US tax forms in all their incomprehensible glory. I also spent considerable time trying to explain to the editorial team that the two risk calculators I discussed in the paper could not be referenced in the approved Vancouver style.
Vancouver style: required elements:
Author. Title [Type of medium]. Place of publication: Publisher; Date of publication [Date of update/revision; Date of citation]. Availability.
I could not use Vancouver style because there was no author, place or date of publication – to start with. They were both on-line tools used to assess cardiovascular risk. Helloooo… ever heard of the Internet. Thud!
Anyway, I was invited to write the article by Dr Eric Westman, who was the guest editor for this edition of ‘Current Opinion in Endocrinology, Diabetes and Obesity.’ In truth, I get about fifty invites a day to write articles. This is not a boast, anyone who has written almost anything that has been published in a medical journal is bombarded with such requests. New journals spring up like desert flowers after the rain.
Most of the requests are, essentially, vanity publishing. You spend ages putting together a paper that you then must pay to get published – you certainly have to pay a lot to allow open access. Usually thousands of dollars. The publisher meanwhile gains copyright. Then hardly anyone ever reads it. But, hey, you can send a copy to your mum – who will be very proud. If none the wiser what you are trying to say.
Thus, I do not respond to such requests normally. But in this case, I did. Eric Westman is a staunch ally in the crusade to look at different causal models of cardiovascular disease. Models not based on LDL/cholesterol levels.
For this edition he also invited others e.g., David Diamond to write other articles casting doubt on the LDL/cholesterol hypothesis – in the proper scientific manner. Dr Westman then paid to make them open access. A cost running into many thousands of dollars. Good man.
For those who have read my blog assiduously, or have read ‘The Clot Thickens’, none of this is new, or any surprise. However, I hope that it does add some more scientific credibility. Here is the abstract.
Abstract
Purpose of review
The low-density lipoprotein (LDL)-cholesterol level is a weak predictor of developing cardiovascular (CV) disease and can only explain a small proportion of CV risk. It is not used to determine CV risk on either the atherosclerotic cardiovascular disease (ASCVD) calculator in the United States, or the Qrisk3 in the UK.
A study in JAMA in 2022 suggested that ‘the absolute benefits of statins are modest and may not be strongly mediated through the degree of LDL reduction’. Perhaps it is time to look beyond cholesterol to a different causal model – the ‘thrombogenic’ model of ASCVD.
Recent findings
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) pandemic demonstrated that infectious agents damage the endothelium and the glycocalyx – the glycoprotein layer protecting underlying endothelial cells. There are numerous other conditions leading to this kind of damage, which can trigger thrombus formation, causing strokes and myocardial infarctions.
Although these are acute events, they highlight a mechanism for the development of ASCVD which centres on endothelial damage and thrombus formation as both the primary causal mechanism for acute events, and the driver behind progression towards atherosclerotic plaque development.
Summary
The cholesterol hypothesis, that a raised LDL is directly causal for ASCVD, does not adequately explain cardiovascular risk in individuals, or populations. An alternative ‘thrombogenic’ hypothesis is proposed as a more valid causal model.
Here are the key points
KEY POINTS
Low-density lipoprotein (LDL)-cholesterol is a weak predictor of cardiovascular risk
Factors that drive endothelial damage and thrombus formation greatly increase atherosclerotic cardiovascular disease (ASCVD) risk.
The thrombogenic can explain a number of causal risk factors that do not fit within the LDL-cholesterol hypothesis, including type II diabetes, smoking and systemic lupus erythematosus.
The thrombogenic hypothesis, that endothelial damage and subsequent clot formation underlies the formation and growth of plaques, may represent a better model for ASCVD.
There is a need to research the thrombogenic hypothesis in more depth.
Stripping away the scientific obfuscation which is now required of all scientific writing. If anyone understands what you are trying to say, you lose. The two points that I was trying to make were the following:
The LDL/cholesterol hypothesis is most likely wrong. It is a weak predictor of risk, at best, and cannot explain how many factors known to increase the risk of cardiovascular disease, actually cause cardiovascular disease.
There is an alternative hypothesis, the ‘thrombogenic’ hypothesis which can explain how, and why, many different, apparently unconnected factors actually do cause cardiovascular disease.
I hope that the readers of this blog can make as much noise about it as possible and share it as widely as possible. You may even want to read the entire paper. It is not very long, and it is not too technical. At least I don’t think so.
As a change in direction, I thought I would share a short story I wrote. This was an entry to the New England Journal of Medicine competition. This one under the theme “A patient who presented too late”. It did not win, but I thought some of the readers of this blog may like it.
THE REASON WHY
The ewe was suffering, lying on its side, its bleat reduced to a painful gasp. ‘It’s nae coming out father.’ Annie wiped the blood down her trouser leg.
He hurled his shovel to the ground in a rage. ‘Whit have you done wrong this time!’
‘Nothing I…’ She stumbled away from him as he hauled open the entrance to the pen. He glared down at the sheep, struggling to give birth. ‘We lose another one, and I’m telling ye.’ He bent down to examine it. ‘Wrong way round. How could you no’ see that?’
‘I…should we call the vet?’
‘Vet!’ He looked ready to explode. ‘Do you ken how much a vet costs… do you?’
‘But it’ll die.’
‘It’s nae worth anything.’
‘It’s… I don’t know.’ Her shoulders slumped.
‘Oh, poor wee Annie disnae want to see the ewe die.’
Annie touched her own stomach lightly, tenderly. ‘No, I.’
‘Get the gun.’
‘Can you no just get it out, please… father?’
‘Dinnae be an idiot.’ His voice was a club. ‘Gun, now. You shoot it, and skin it. We freeze it and eat it ourselves.’
She stumbled out of the barn, into a fierce wind. Rain and sleet blowing down from the North, falling in sheets from heavy dark clouds. The hills above were now laced with wet snow. The courtyard glistening, moss covered, slippery. The house was freezing inside. The gun in a cupboard below the stairs.
She pulled it out and made her way back to the kitchen. For a moment she held the gun up, squinting through the sights. She could make out her father’s angry back through the dirty window. He turned, and for a moment, it was as though he were staring straight at her. But she knew he wouldn’t be able to see her, standing alone within a darkened room … Watching, heart beating too fast.
‘Hey Annie.’ Arthur was striding along a path beside the field. The sun was high, it was a lovely day, with small flowers studded amongst the grass. Below her the Cromarty Firth shone like a steel plate, as the sea cleaved the hills on either side. A lark was singing frantically above her, hovering high, a fluttering dot. She loved the early summer up here.
She was in a t-shirt and jeans, trying to fix the tap that fed a trough for the cattle. It was old, rusted, they badly needed a new one. Her fingers were already cut in several places.
‘Hello Arthur.’ She didn’t look up, but she knew he was studying her with interest. She pulled the t-shirt more closely round her neck.
‘Do you need a hand?’ He worked at the farm next door. She had watched him from a distance. Driving the tractor, chatting with other workers, talking to his cows. Yelling at them. Kicking them when they wouldn’t move, then laughing. At night, sometimes, she thought about him.
‘Just look at you.’ He had come up close. He took one of her hands in his, examining it with care. ‘What are you doing to yourself?’
‘The tap needed fixed.’ She allowed her hand to rest in his.
‘That piece o’ rusting rubbish?’ He laughed. ‘You’ll no fix that. You need a new one.’
‘Father says we cannae afford it.’
‘Aye… well I’m sure he did. I’m sure he did.’ For once, there was no trace of humour in his voice. ‘What about you Annie?’
‘Whit do you mean?’ She flushed.
‘Up here, by yourself, stuck wi’ your gloomy dad. What does Annie do?’
‘I work…’ She glanced round, making sure her father was nowhere nearby, watching. ‘The farm needs me, after mother died.’
‘I hear you have a brother. Big lad.’
‘Aye, but he… he left. He hasnae been back for years now. He works in the big city.’
‘What, Inverness. Aye, the great big city. Even got a MacDonald’s, might just be the centre of the World. Mind, he could walk back in a day… if he wanted.’
‘Well, I don’t know.’ She had no idea what to say next. She wasn’t good at conversations. She didn’t have many. An awkward chat about the weather over a cup of tea, down at the kirk on a Sunday. A half-hearted promise to visit from one of her mother’s old friends. Nobody really wanted to come to the farm anymore.
‘A bonnie lass like you.’ He touched her shoulder lightly. For a moment she allowed herself to lean in towards him.
‘No…No. I cannae stay.’ She leapt up.
‘Hey, hey up Annie. I didnae do anything.’
‘I …I have to go!’ She gathered her things together furiously into a leather bag, then almost ran up the road. Arthur watched her. He always noticed when she was in the fields. Working the dogs, driving the tractor, hair blowing in the wind like some Pictish warrior queen. That long vanished race who once roamed these lands. She always looked to be concentrating furiously, passionately, on everything she did. She made him feel alive, and awkward, like a wee boy…
…This night, the pain was worse than ever, grabbing at her stomach fiercely. Her periods had almost stopped and… and she reached down to touch her stomach. It was definitely growing. ‘You’re getting fat. I cannae have you slowing down, not now.’ Her father had snapped.
How she wished her mother was with her to offer some comfort and kindness. After she died, her father had become so different. Angry, shouting, red faced. He would be sitting slumped in front of the coal fire now, whisky bottle close to hand, no doubt. Staring at the flames.
Sometimes though. Sometimes he came to her room, and he was different then. She reached down to scratch the head of her Bramble, her collie dog. Bramble licked her hand.
‘Whit can I do lassie.’ Annie looked down into Bramble’s adoring eyes. ‘Whit can I do.’ She closed her eyes tightly as the pain caught at her again. She wondered about going to the doctor. Then she thought about her father finding out. What if it was a child… what if it was a child?’ The thought filled her with desperate longing, and terror. She knew you could get tests, but…
‘How many this morning.’ I felt the need for an early finish. It had been an unrelenting week.
‘Sixteen, the usual.’ Jill, the receptionist, brought my list up on her screen. I was the on-call doctor, starting early.
Five regulars, who were all depressingly regular in their visits and vague, never ending, untreatable complaints. ‘Who’s that first one, never seen her before. Anne Pierce? You know her?’ Jill had been born and brought up locally, she always seemed to know everyone, and everything about them. Mother to every waif and stray.
‘That’s her, she was waiting when I opened the door. Arthur Mackenzie brought her down, I saw him in the car, pretending he wasn’t watching.’ Jill kept her voice low and nodded towards the only patient in the waiting room. Hands gripped together; head down, staring at the floor. Hair dragged back a painfully tight bun. ‘She lives with her father on High Range farm, poor lass.’
‘Poor lass? Tell me more.’
‘Her father is…’ Jill flushed.
‘He is, what? Is this the secret service?’ I whispered into her ear.
Jill giggled. ‘Not very nice.’ I knew she would say nothing more. Miss confidentiality. Even though I was the doctor.
‘Well, if she’s a farmer, it must be something serious.’ Famers were notorious for putting up with anything. Bone broken after a fall… ‘Just a wee break, strapped a couple of bits of wood round it, hurts a bit when I walk.’ Or coughing up blood. ‘Just a wee cough, had it three years. Took some of the antibiotics we use for the cattle. Thought it would clear up doc.’ Yes, well, everything clears up when you’re in a coffin.
Annie had entered the room without meeting my eye. Her history had been simple. Abdominal pain, a bit of swelling. No periods. The pregnancy test I gave her to do was negative. She had been jumpy, wary, an injured bird. I watched the silent spasm of pain on her face as she got up on the couch.
Her abdomen was certainly enlarged, but it didn’t seem like any pregnancy I had seen before. I put my hand on and pressed down. It was like pushing on a car tyre. Hard, very hard. I tried to find an edge, but there was none. A mass was literally filling her abdomen. It must have been the size of a pillow. This was one of the few times when I had absolutely no idea what to say to a patient.
‘Are you okay doctor.’ My attempt to hide my emotions had failed completely. She seemed more concerned about me than her.
‘Yes, yes, thanks. But I think we may need to get you looked at.’
I find vaccines quite fascinating. To be more accurate, I find the thinking and emotion around vaccines endlessly fascinating… and often quite disturbing. They have become, what we in the UK call ‘national treasures.’
A national treasure is someone, such as Dame Judi Dench, or Sir David Attenborough. We laugh at their little jokes, we forgive them any possible weakness, we treat their statements as carrying a great and solemn weight. They have moved to a sainted realm.
If, for example, someone was to say about David Attenborough. ‘God, what a terrible bore. Time he was put into a nursing home, and stopped moaning on about Climate Change…’ This statement would not, I can guarantee, be met with Universal approval.’ Moving on …
Mithridatism. Most people have never heard of it.
‘Mithridatism is the practice of protecting oneself against a poison by gradually self-administering non-lethal amounts. The word is derived from Mithridates VI, the King of Pontus, who so feared being poisoned that he regularly ingested small doses, aiming to develop immunity.’ From my favourite website of all time – Wikipedia. Hey, before you start, it’s good for non-contentious subjects.
From mithridatism came the substance Theriac Mithridatium. Also called Galene, or Venetian treacle. These were the universal panaceas, designed to cure all ailments suffered by mankind … and, of course, womankind. They were complex to prepare:
‘The preparation of Galene was simple in that its ingredients were free of fractional measures. Four vipers cut down small were placed in a solution of sal ammoniac, about one gallon, to which were added nine specified herbs and Attic wine, together with five fresh squills also cut down small. The pot was covered with clay and set upon a fire. When the vapour came out of the four small holes left in the clay seal, dark and turgid, the heat had reached the vipers and they were cooked. The pot was left to cool for a night and day. The roasted matter was taken out and pounded until all was reduced to powder. After 10 days the powder was ready for the next stage of manufacture.
At the final stage the prescribed quantities of 55 herbs previously prepared by various processes, along with the prescribed quantity of squill and viper flesh powder (48 drachms), were added to hedychium, long pepper and poppy juice (all at 24 drachms); eight herbs including cinnamon and opobalsam (all at 12 drachms); 18 herbs including myrrh, black and white pepper and turpentine resin (at 6 drachms); 22 others and then Lemnian earth and roasted copper (at 4 drachms each); bitumen and castoreum (the secretion of beaver); 150 drachms of honey and 80 drachms of vetch meal.
The concoction took some 40 days to prepare, after which the process of maturation began. Twelve years was considered by Galen the proper period to keep it before use. Galen records that the Emperor Marcus Aurelius consumed the preparation within 2 months of its being compounded without ill effect.
Mithridatium was similar but contained fewer ingredients and no viper but did contain lizard! The other differences were that the opium content of Andromachus’ theriac was higher than that of Mithridatium, which also differed in containing no Lemnian earth, copper or bitumen and 14 fewer herbal ingredients…’ 1
Simple to prepare … I think I would prefer to make a bacon sandwich, thanks very much.
Various formulations of mithridatium were painstakingly put together, in public, to ensure that no-one was cutting corners, by substituting newt for lizard – or some other such underhand substitutions. Yes, it was vitally important that mithridatium was made of pure unadulterated nonsense. No cut-price, corner-cutting nonsense here, thank you very much. It was then sold for a fortune. And people flocked to buy it.
The manufacture of mithridatium, and its variants, went on from the second century BC to the end of the eighteenth century. Or, to frame this another way. The idea of creating a substance that contained small portions of various poisons, in order to allow the body to build up immunity, and fight off all illnesses and infections, has an extremely long history.
All doctors in the mid to late eighteenth century would have been acutely aware of mithridatium, and its variants, and the thinking behind it.
William Heberden, a famous UK physician, is the man we can most credit with attacking the idea of ‘Mithridatium and Theriaca’. His pamphlet on the matter was written in 1745. He argued that it was all complete, unscientific, twaddle. Following this, and other attacks, the sales of Theriac mithridatium suffered a rapid decline.
By the end of the eighteenth century Mithridatium had pretty much disappeared from the world. To the point whereby nowadays ninety-nine per cent of people – or more – have no idea that such a substance ever existed. Or how hugely significant it was.
Let us move on a few years to 1796. A moment in time when an eight-year-old boy, James Phipps, was inoculated with ‘matter’ from Sarah Nelms, a dairy-maid, who had cowpox. Three months later, the same boy was ‘inoculated’ with fresh ‘matter’ from a smallpox lesion – and no disease developed. Lucky boy. Not sure you would get that past the ethics committee today. ‘I am fairly confident that he will not die of smallpox ... probably.’
Yes, as mithridatism departed from this world, vaccination moved in to take up the available space – a different substance to protect against future illness. In truth, the idea of inoculating people with small amounts of smallpox ‘matter’ to help the body fight off a more serious infection had been around for some time before this.
It was carried out in China, Africa, and the Ottoman empire perhaps for, hundreds of years. Although the idea that it is possible to have a ‘small’ inoculation with a deadly virus is interesting …. Do not try this at home.
To me, the important point I am trying to make here, is that the underlying idea behind vaccination had been around for millennia. Vaccination was, in effect, a variation on the theme of mithridatism.
However, the idea that a cowpox infection could protect against future smallpox was new, and it was Jenner’s idea. At least he made the most noise about it. Others claim it was Benjamin Jesty. Who knows? Success has a thousand authors, failure but one.
I think I shall credit the milk maids instead. They had known for many years that if you got infected with cowpox, you were protected against smallpox. An observation that Jenner picked up on, then ran with. Good for him …
‘… The record shows that it was there that Jenner heard a dairymaid say, “I shall never have smallpox for I have had cowpox. I shall never have an ugly pockmarked face.” In fact, it was a common belief that dairymaids were in some way protected from smallpox.’ 2
But, of course, at the time all this this was complete speculation and guesswork. When vaccination began no-one knew that there such things as bacteria, or viruses. No-one knew there was an immune system. No-one had the faintest idea about T-cells and B-cells and suchlike. Which leads to the question. What did Jenner actually think he was doing? How did he believe vaccination could possibly work?
After all, he was experimenting with vaccination decades before germ theory had emerged. This happened in the late(r) nineteenth century. A time when Pasteur, John Snow and the like, finally managed to convince the medical profession that infectious diseases were not spread by Miasma – essentially nasty smelly stuff that floated about in the atmosphere. Instead, disease was spread by very small ‘germs.’
If Jenner did not know that germs existed, what did he think was causing smallpox? If it was via miasma, how would vaccination work? A part of me thinks that he must have believed that a physical agent, or some sort, was causing ‘pox’. Otherwise, why would he scrape away at cowpox blisters to get ‘stuff’ off. He couldn’t have believed he was transferring miasma from one person to another.
Maybe he thought the miasma theory was complete nonsense but didn’t dare point this out. Semmelweis certainly found out, to his cost, that trying to suggest infection could be passed on by physical contact was not well received.
A Hungarian physician, he did some thinking, and research, on how infections were passed on. He recommended that it might be a good idea if doctors might just, possibly might, consider washing their hands after doing a post-mortem … then helping women to deliver their babies.
For which heresy, he ended up being flung into a lunatic asylum. He was later beaten to death by a warden. This was some forty years after Jenner began his experiments on vaccination. Yes, Semmelweis is now a very famous figure in the history of medicine, the ‘saviour of mothers’ but it didn’t do him much good at the time.
As you can probably tell, I find the development of medical thinking – indeed all scientific thinking – to be fascinating. Where do the ideas come from? At times I believe it is all complete luck. Good ideas, bonkers ideas, they all appear to be taken up with equal enthusiasm. All you need is a good tale and a charismatic promoter, then off you go.
‘It was not noisy prejudice that caused the work of Mendel to lie dead for thirty years, but the sheer inability of contemporary opinion to distinguish between a new idea and nonsense.’ Wilfred Trotter
With vaccination though, there was no major new idea. There were two thousand years of Mithridatism to build on. Namely, use a small amount of a substance to create future immunity. A general concept that was, and remains, highly seductive to the human mind. With vaccination it just happened to be right.
However, it could just as easily have been wrong. For example, the thinking behind mithridatism also underpins homeopathy. A concept that first came to Samuel Hahnemann. A doctor who obtained his medical degree in 1779. Yes, he was kicking around at very much the same time as Jenner.
‘Hahnemann believed that if a patient had an illness, it could be cured by giving a medicine which, if given to a healthy person, would produce similar symptoms of that same illness but to a slighter degree. Thus, if a patient was suffering from severe nausea, he was given a medicine which in a healthy person would provoke mild nausea. By a process he called ‘proving’, Hahnemann claimed to be able to compile a selection of appropriate remedies. This led to his famous aphorism, ‘like cures like’, which is often called the ‘principle of similars’; and he cited Jenner’s use of cowpox vaccination to prevent smallpox as an example.’3
It is said that the idea of homeopathy first popped into Hahnemann’s head because he noted that quinine, in small doses, created similarly symptoms to malaria, although in a much milder form. So, he tried to use quinine to protect against malaria. Then he expanded the concept, to infinity and beyond.
Mind you, the use of quinine to protect against malaria led to the creation of tonic water, to protect the British in India. This, in turn, led to the creation of gin and tonic. So, Hahnemann must be celebrated for this wonderous legacy, at least. Yes, for this, I can forgive him just about everything.
And, of course, quinine does protect against malaria. If not that well. Oh, the delicious irony.
Mithridatism: Ingestion of small doses of poisons to create immunity
Homeopathy: Use of very small doses of a substance to create immunity/cure
Vaccination: Deliberate infection, using small doses of an agent, to create immunity
Mithridatism is gone
Homeopathy is mocked
Vaccination is venerated
Imagine if, on the other hand, Jenner had decided to keep on using smallpox scrapings to try and prevent a later, more deadly smallpox infection. Maybe vaccination would never have happened, at all.
Just to give one example of the problems with smallpox inoculation. In 1783, Prince Octavius, the youngest son of King George II was inoculated with the smallpox virus. He died soon after – of smallpox. Had King George then taken violently against ‘vaccination’ at this point, the entire idea may have died right then and there. At least in the UK.
Instead, with Jenner came the crossroads. The point where mithridatism, homeopathy, and vaccination parted company. One works, the other two don’t.
This is because there is no such thing as a vanishingly small dose of an infection. You get infected, or you do not. The dose is pretty much irrelevant. Of course, what happens after infection can vary enormously. Some people get no symptoms, at all, others may die.
The key point of difference with vaccination is that you are notgiving a small dose of the infective agent – however vanishingly small. The point, the critical difference, is that you have to give ‘something else’ instead. Something other than the actual infective agent. This stimulates the immune system and leads to the creation of memory cells that will recognise a ‘similar’ agent in the future, and then kill it off. Hopefully.
However, there is no way on earth that Jenner, or anyone else at the time, would have had the slightest idea why this would be the case. They thought it might work. So, they did it, and it worked. And lo, vaccination was born.
It amuses to me look at articles describing the history of vaccination, and Edward Jenner, and compare them with – for example – articles on Hahnemann:
‘While it can scarcely compare in antiquity with Chinese or Indian medicine, homeopathy is the longest established CAM (complementary medicine) to have arisen in Europe. It was founded by Samuel Hahnemann (1755-1843), who grew up in Meissen in Germany, received his medical degree in Erlangen in 1779, and died a millionaire in Paris in 1843. During his first fifteen years as a physician Hahnemann struggled desperately to make a living.’4
If we turn to Jenner …
In addition to his training and experience in biology, Jenner made great progress in clinical surgery while studying with John Hunter in London … In 1773, at the end of two years with John Hunter, Jenner returned to Berkeley to practice medicine. There he enjoyed substantial success, for he was capable, skillful, and popular. In addition to the practice of medicine, he joined two local medical groups for the promotion of medical knowledge and continued to write occasional medical papers. He also played the violin in a musical club and wrote light verse and poetry. As a natural scientist, he continued to make many observations on birds and the hibernation of hedgehogs and collected many specimens for John Hunter in London.
So, it seems that, on one hand, Hahnemann was both a scoundrel, and a failure as a doctor. Only when he turned to the dark side, did he become that worst of all things. A greedy millionaire, selling snake oil.
On the other hand, Jenner was virtually a saint. A man both skilful and popular, and successful. He even wrote poetry (unlikely to be a good thing in my opinion) and he played the violin (almost certainly not a good thing). My goodness, this is a man you would want your daughter to marry. An intelligent man, a man of the most delicate and thoughtful sensibilities, was he not …
‘Although he received worldwide recognition and many honors, Jenner made no attempt to enrich himself through his discovery. He actually devoted so much time to the cause of vaccination that his private practice and his personal affairs suffered severely.’
Maybe this wasn’t a man you would want your daughter to marry … after all, ‘It is a truth universally acknowledged, that a single man in possession of good fortune, must be in want of a wife.’ So, Hahnemann, in possession of a good fortune as he was, might have been a better choice.
Despite his lack of money, indeed because of it – Jenner has become a historical national treasure. A selfless searcher for the truth. A delicate man, a popular man, a sensitive man. A man with a soul above such grubby things as making money… and suchlike. One is reminded of the propaganda surrounding Kim Jong-Il. The first time he played golf, he had eleven holes in one …
‘That time Kim Jong-Il tried golf for the first time and finished with 11 holes-in-one to achieve a 38-under-par game on a championship 18-hole golf course.’5
I imagine Jenner would have had twelve holes in one. Playing blindfolded, whilst entertaining an enraptured crowd with an impromptu violin and poetry recital. All for free, of course.
Yes, Jenner is a now national treasure; vaccination has also become a national treasure. Both exist in a realm above all criticism. This is never a good thing. Particularly not in the world of science. But it has happened. Dare to critically examine either, at your great peril. Try suggesting that the whole concept of vaccination was pure luck, primarily based on a two-thousand-year-old idea, and you will be attacked. This, I guarantee.
Here is a sorry tale about the power of the pharmaceutical industry to crush all dissent … dead. The key player is Dr. Aseem Malhotra, who some of you may know. He is a consultant cardiologist. Very bright, sparky, willing to take on the establishment when required. I get on well with him, we communicate on many different issues. He has his detractors – I am not one of them.
First, some background, to put this tale into some kind of context. It is part of an e-mail that I was sent, by Aseem. I I have modified it slightly. Basically, I changed it from first person and got rid of some typos. I have also checked with other independent witnesses, to ensure the accuracy of events:
‘Dr Aseem Malhotra was invited to deliver a keynote lecture/speech at the International Medical Graduates dinner by its organiser, Consultant Psychiatrist and Chair of the British Association of Physicians of Indian Origin (BAPIO) Dr JS Bamrah CBE. The event took place on Monday 27th June as a fringe event of the British Medical Association (BMA) Annual Representative Meeting (ARM).
Other chief guests included the Chair of the BMA (Dr Chaand Nagpaul) and the President of the BMA (Professor Nina Modi). The title of his talk was “Advocating for REAL evidence-based medicine”.
The talk was well received with excellent personal feedback including the Chair of BAPIO, Dr JS Bamrah. The event also commemorated Aseem’s late father Dr Kailash Chand Malhotra who died suddenly last year. He was honorary vice president of the BMA and on the BMA council.
The organiser of BMA education events Beryl De Souza also personally told Aseem it was a brilliant talk, and the next day sent him a text message asking him to present the same talk as an educational webinar to BMA members.
Aseem had also given a talk to over one hundred BMA members earlier in the year about heart disease, statins and cholesterol with excellent feedback. The Chairman of the British Egyptian Medical Association who was very complimentary about the talk also met Aseem the following day and asked if he would give the same talk to his members.’
It all sounded rather splendid, and mainstream, and suchlike.
But, gentle reader, beware. For there is a malignant ghost hovering over this feast. The ghost of ‘anti-vaxxer present’. Now it doesn’t take much to be accused of being an anti-vaxxer. The phrase ‘I have some concerns about mRNA vaccines’ is usually enough to be mercilessly attacked by the dementors, controlled by Facebook, Twitter and suchlike.
In this case, during his talk, Aseem presented data from a study called ‘Serious Adverse Events of Special Interest Following mRNA Vaccination in Randomized Trials.’
It is a pre-print paper, at this point, and has not yet been peer-reviewed. It is due to be published in the Elsevier journal SSRN. You can see the full paper here 1.
The authors, from such places as Stanford, UCLA and Maryland, are of high academic standing. What they did was to look at serious adverse events associated with the Pfizer and Moderna vaccines. The Discussion section of the paper states the following:
‘The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes such as hospitalization or death.’
The ‘abstract’ further states, in the results section:
‘Pfizer and Moderna mRNA COVID-19 vaccines were associated with an increased risk of serious adverse events of special interest, with an absolute risk increase of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95% CI -0.4 to 20.6 and -3.6 to 33.8) respectively.
Combined, the mRNA vaccines were associated with an absolute risk increase of serious adverse events of special interest of 12.5 per 10,000 (95% CI 2.1 to 22.9). The excess risk of serious adverse events of special interest surpassed the risk reduction for COVID-19 hospitalization relative to the placebo group in both Pfizer and Moderna trials (2.3 and 6.4 per 10,000 participants, respectively).’
Now, in English. According to this paper, the risk of a serious adverse event (caused by the vaccine) was greater than the reduction in hospitalisation from COVID-19 (prevented by the vaccine). Therefore, on this metric, the vaccine(s) may be doing more harm than good. [Please don’t hit me, I said ‘may’.]
Thus, Aseem committed the greatest sin imaginable today. He dared to mention a scientific study that asked questions about mRNA vaccines. And, of course, oops, I have now mentioned it too. Which clearly makes me an anti-vaxxer. Yes, quoting scientific papers is now, virtually, a crime. So, I have to strongly advise you … don’t look at the paper. Else you will become contaminated with impure thoughts and may have to be stomped on.
Oh, what a world we now live in.
Anyway. Back to Aseem’s story. Here he was, basking in glory. To top it all, he was then presented with an award. To quote … with some slight edits:
‘The next day Dr JS Bamrah informed Aseem that he was going to receive an award, to be presented by the BMA Chair, Dr Nagpaul. The award was “Champion of Preventative Medicine”. He had spoken to Dr Nagpaul on the phone who agreed.
The award was given in a break at the BMA conference. Dr Nagpaul was asked where he wants the photo to be taken of him presenting Aseem with the award. He suggested the main podium at the BMA conference hall, but the picture quality is poor, so they go elsewhere, and Dr Nagpaul was more than happy for Aseem to receive the award in front of a board in the main lobby with the BMA logo in the background. This was NOT Aseem’s suggestion.
Later that afternoon (Tuesday 28th) Aseem received the photo via text and put a tweet out (see below) in the evening with the three photos of Aseem receiving the award including with a larger group of people including the BMA president which read:
“Truly honoured to receive the “Champion of Preventive Medicine award from the Chair of the BMA @Cnagpaul. In my talk I said the science alone isn’t enough; opposition from vested interests needs to be overcome to save the #NHS. It’s time for REAL evidence-based medicine (fist bump emoji).’
But the all-seeing eye of Sauron had been ‘observing’ this unfortunate series of events. Grima Wormtongue was dispatched to whisper in the ears of those in power. ‘Yes, my precious (to mix my characters, stories, and metaphors, horribly), nasty hobbitses won’t be seen to criticise vaccines will they.’
Behind the scenes … all hell broke loose. Someone had dared to mention a study mildly critical of vaccines, and the BMA chairman GAVE HIM AN AWARD. Off with his head. ‘Whose head, please?’
‘Everyone involved in this treachery.’
‘Yes boss, sure boss, right away boss….’
The tale continues:
‘The next morning, Aseem noticed a missed call and message from Dr Bamrah. “Please call Aseem. Need your tweet modified. Delete the bit about BMA council. Just say Chaand Nagpaul. Happy to explain.”
Aseem did as requested and sent another tweet specifically clarifying that it was an IMG forum award and was given to me by Chaand Nagpaul, without mentioning the BMA at all. Aseem also messaged Dr Bamrah in reference to Chaand which he also shared with him “He needs to stand his ground and not capitulate. We’ve compromised by deleting the tweet. My dad would say always stand up to bullies and cowards – that’s what he taught me.”
Chaand (CN) replies to me “Aseem the issue is who the award originated from. They’re questioning my governance – it was not an award “from me”. I know it’s semantics but real uproar”
AM: “Ok. I will delete the tweet altogether”
CN: “Much wider than this individual – within BMA too sadly – everything attributed to me has to be cleared with BMA comms while BMA chair”
AM: “Tweet deleted”
CN: “I’m going to get some sleep! It’s been incessant”
BMA releases a statement from the Chair that is read out at the conference essentially stating that the BMA does not endorse the views of Dr Aseem Malhotra and that Chaand had not actually given me the award but had “handed it over” due to politeness.
Why such a storm? Why the behind-the-scenes desperate machinations to ensure that the BMA could not, and would not be associated in any way with Aseem? Why the personal humiliations and climbdowns? Why the control over Chaand Nagpaul – who was stepping down as BMA chairman anyway? The incessant tweeting and criticism.
Was it because Aseem has always been critical of vaccines? I refer you to the fact that in early 2021 Aseem was asked to help promote the COVID-19 vaccine to the, so called, BAME (Black Asian Minority Ethnic) community. Yes, he promoted the vaccine to a particular vaccine hesitant community 2.
However, he has also, like me, been alert to the possibility of potential harm that the vaccines may cause. He is also, like me, well aware of the way that data from clinical studies can be, and is, manipulated and biased.
We both cast a highly sceptical eye over any ‘evidence’ that emerges from commercial organisations. Neither of us happily chants ‘two vaccines good, four vaccines better.’ We are both in the ‘but that man is wearing no clothes’ section of the audience. A rather smaller section, it must be said. Usually containing only two people. Him, and me.
Anyway, I thought it would be interesting to find out who, exactly, started the ‘bring me the head of Aseem Malhotra’ movement within the BMA. Could it be, I wondered, that they had a commercial conflict of interest? By which I mean, had they worked with a pharmaceutical company that made mRNA COVID19 vaccines.
Well, I have spoken to people within the BMA, at a high level, to find out exactly what went on. They confirm the details of Aseem’s story. But wish to remain nameless. It seems that a certain individual, who led the attack on Aseem, has close connections with Moderna. Surprise, surprise. As you can tell, I am treading on potentially libellous ground here, so I am not naming names. I am currently involved in a monstrously long, and complex libel suit, and I don’t want another one at present, thank you very much.
This all comes hot on the heels of an article in the British Medical Journal by Maryanne Demasi. A medical journalist whose career was destroyed when she produced and presented programmes in Australia that were critical of the cholesterol hypothesis and the, potential, over-prescribing of statins. They even tried to get her PhD removed, to further destroy her reputation.
The BMJ article was called ‘From FDA to MHRA: are drug regulators for hire?’
‘Patients and doctors expect drug regulators to provide an unbiased, rigorous assessment of investigational medicines before they hit the market. But do they have sufficient independence from the companies they are meant to regulate?’3
The short answer is no. Drug regulators have been bought and paid for by the companies that they are supposed to regulate. But the commercial influence spreads far wider than the regulators. Key opinion leaders (KOLs) who carry out the big clinical trials, who speak at conferences, and who appear at the top of influential medical organisations and write the guidelines – are often bought and paid for too.
There is virtually no area of the medical world that has not been lobbied, infiltrated and – in many cases – paid for and controlled by the pharmaceutical industry. We have a major crisis on our hands, that no-one is doing anything about.
Aseem’s tale is just one more example of the fact that anyone who dares to stand up to the relentless marketing of more and more drugs, and vaccines, will be attacked and crushed. In this case, under the banner of the British Medical Association. An organisation that I am increasingly unproud to be a member of. If the BMA can no longer support freedom of speech, then no-one can. The future looks bleak.
To quote George Orwell. ‘If you want a picture of the future, imagine a boot stamping on a human face, forever.’
For those of you who are regular readers of my blog, you may have noted little activity recently. I found myself diagnosed with prostate cancer, and then radiotherapy, and anti-androgens, then in the midst of that I went down with COVID19. So, energy levels have been a little low. Particularly my ability to concentrate on writing, anything of great value.
I am going to give it a month, or so, to see how I feel. Then, I hope to be back on-line after that. I wil get back to approving comments this week. Thank you.
I love the phrase ‘lessons need to be learned’. It always makes me laugh when I hear it. Usually intoned with a voice of great seriousness by the leaders of an organisation found to have made disastrous errors. It is right up there with ‘safety is our number one priority.’ About the only group I have yet to hear say this are arms manufacturers. Although I wouldn’t put it past them. Maybe … ‘You could take someone’s eye out with that.’
As I have occasionally remarked about airlines … when they tell us that safety is their number one priority. Well, in that case don’t take off. Everything is perfectly safe when your plane is on the ground. It’s that hurling yourself into the air, dashing about in the skies, then landing, where all the accidents take place.
Getting back to lessons learned. The only lesson I have ever learned, about lessons being learned, is that lessons are never learned. The same disasters occur again, and again, for all the same reasons. The reasons being institutional inertia and the overwhelming desire of those at the top to protect themselves from any criticism.
What I have also learned is that the primary function of any enquiry is to make sure that no-one who actually made those terrible decisions can be blamed for anything. A few scapegoats further down the pecking order will be dragged out and punished. Then all goes quiet again.
‘Mistakes were made.’ This is another one I enjoy. Mistakes were made – but who made them? The use of the passive voice is all you ever need to pay attention to Here. You never hear. ‘I made this mistake. Or, that person made this mistake.’ Even more rarely will you hear ‘I, alone, made this mistake.’
Yes, once the dreaded passive voice comes into play, you know that no-one is going to be singled out, no lessons are going to be learned by anyone. Instead, some vague unidentifiable entity will have to learn from the mistakes that some other vague and unidentifiable entity may, or may not, have made.
Mistakes were certainly made in the COVID19 pandemic, and I have found myself bombarded by the ‘lessons have been learned’ claptrap.
The man in charge of healthcare in the UK, when COVID19 crashed upon the world, was Matt Hancock. This was also the time when patients were being flung out of hospitals into care homes, thousands of whom then went on to die.
He chose to hide behind an excuse. ‘No-one told me, so it wasn’t my fault.’ Is that what the Captain of the Titanic thought to himself as his ship slipped beneath the waves?
Here is one article about what went on during that terrible time. I cannot reference it for everyone, because it came to me through doctors.net, which is for doctors in the UK only. Here it is anyway, although, unless you are a doctor you will have no access. ‘Poor planning behind the illegal pandemic care home discharges’1. By the way, you are not missing anything. It mirrors many other articles that said exactly the same thing:
Bed shortages led to the illegal discharge policies that led to the deaths of hundreds of patients in care homes, the British Medical Association has alleged.
A court yesterday delivered a ground-breaking ruling that the government acted unlawfully in the advice it issued to the NHS on hospital discharge during the early stages of the pandemic.
The advice stated that there was not a risk from patients who had no symptoms of COVID infection. It led to the virus running amok in the care sector and a judicial review by two bereaved relatives gained the support of the courts yesterday.
I would disagree with the statement that hundreds of deaths occurred. It was in the region of twenty to thirty thousand, maybe more. What was Matt Hancock’s response?
Yesterday he (Matt Hancock) claimed the court ruling had not found him culpable, blaming Public Health England for failing to advise that the asymptomatic patients could transmit the virus.
So, what lesson do we think Matt Hancock has learned? ‘A big boy (public health England) made me do it’, seems an adequate summary. Yes, we know there was a lot going on at the time. A great deal of pressure, and panic, and suchlike.
Using pressure in a rapid changing situation as an excuse, as this Government has repeatedly done … This makes me think of a General explaining that all the mistakes he made during a battle were due to people rushing about firing guns and yelling. No-one can possibly concentrate, and get things right, with all that bloody racket going on.
The reason why you had a position of such power and responsibility, Mr Hancock, is that you needed to be the big grown-up boy. You were required to think quickly, and clearly. If people didn’t tell you things, such as the fact that an airborne virus can spread though asymptomatic people – as they all do, then, quite frankly, you bloody well needed to ask.
Of course, it seems he was told, he just doesn’t want to admit that he was … and someone has told him he can probably get away with that pathetic excuse, of an excuse:
Here is what, I think, he should have said. ‘Whilst the situation was difficult, I should have ensured that I looked at this issue in more detail. I needed to find out more about the impact of discharging elderly people back into care homes. The risk of transmission with asymptomatic patients. The difficulty in isolating elderly and often demented patients in that environment. I did not do any of these things adequately. I was the man in charge, I am deeply sorry … please hand me a gun.’
It is not as if this impending disaster was beyond the understanding of us mere mortals. On the 17th April 2020 I wrote a blog about it:
‘The government’s disregard of care home residents – old, sick people, acutely vulnerable to COVID19 – has been scandalous. As a GP, I regularly visit care homes. At one I visit, they recently had eight residents who died in a week, probably from coronavirus. But there’s no testing, so who could possibly know …
When COVID struck, many things were not known, and could not have been accurately predicted. The transmission rate, the case fatality rate, the best way to treat those infected
However, it was very clear, very early on, that COVID was killing the elderly in far greater numbers than anyone else. In Italy, the early figures released revealed that the average age of death was seventy-nine. The figures were slightly higher in Germany, and around eighty years old in pretty much every other country.
Equally, it was known that amongst the elderly who were dying, almost all of them had other serious medical conditions. Heart disease, high blood pressure, diabetes, chronic pulmonary disease and suchlike. This is often known in my line of work as “multimorbidity.”
In a world of uncertainty, one thing stood out. Which is that the unwell elderly were the ones who were most likely to die. Equally, they were the ones most likely to end up in hospital, potentially overwhelming the health services. As happened in Italy and Spain.
Ergo, you would think that someone, somewhere in the UK government, would have asked the obvious question. Where do we have the greatest concentrations of elderly, frail, people with multimorbidity? Could it possibly be that they are being looked after in care homes around the country?
Nursing homes, residential homes, care homes. They are all pretty much the same thing nowadays. Nursing homes tend to look after those with greater health needs, and they must have registered nurses looking after patients, but the distinctions have become blurred.
Many care homes are also specialised in looking after the elderly with dementia. In the UK, they are called EMI units [elderly mentally infirm]. These represent a particular problem in that residents tend to wander about from room to room.
So, in care homes we potentially had the perfect storm for the pandemic. They are full of elderly and infirm and highly vulnerable people. Environments where it is often impossible to isolate residents, and staff who have never been adequately trained in isolation measures. Equally, whilst relatives cannot visit hospitals, care homes have been continuing to allow them in.
It is not as if the warning signs were not there, flashing red.
What was the government’s strategy for dealing with nursing homes? It has been, up until the last couple of days, to make things even worse. The instructions from the Dept of Health have been to send patients diagnosed with COVID out of hospital, and back into care homes, with further instructions to “barrier nurse” them, a term for a set of stringent infection control techniques. Care homes were informed that they could not refuse to take the residents back …’ 2
It was after this that Dr Kathy Gardner (PhD, not medical doctor) contacted me, as her father had died of COVID19 in a care home. I wrote various lengthy replies to her lawyers about the situation, and my experience thereof. They may, or may not, have used my missives in the court case. The case that she battled so long and hard to get heard. She is quoted in the article:
At the time the Health Secretary Matt Hancock had claimed he was throwing a “protective ring” around care homes.
Yesterday he claimed the court ruling had not found him culpable, blaming Public Health England for failing to advise that the asymptomatic patients could transmit the virus.
One of the claimants, Dr Cathy Gardner, said the “protective ring” had proved to be a “despicable lie.”
Dr Gardner said: “I believed all along that my father and other residents of care homes were neglected and let down by the government. The high court has now vindicated that belief, and our campaign to expose the truth.’
Within the NHS I was also fighting my own lonely battles. Here is an e-mail (identifiers redacted) that I send to my manager in April 2020
‘I had a short chat with A yesterday about nursing homes X and Y.
Although things seem to be getting sorted out at Intermediate Care facility B there do not seem to have been any changes at nursing homes X and Y Both homes have several patients with Covid (proven positive swabs). It seems that the Hub is still sending Covid negative patients into both homes – putting these patients at immense risk. We have had staff to patient transmission at Intermediate Care facility B.
Equally patients are being discharged home without having swabs. So, they are arriving home and potentially infecting any partner living there – usually elderly and vulnerable. Equally, if community staff are going in to visit, they can also get infected – then pass the infection on to other clients in the community. The only patients being swabbed on discharge from nursing home X are those going to other care homes – at that care homes request.
Two out of three swabbed patients in nursing home X have come back positive. Which means we are clearly sending Covid positive patients back home – without a swab. I spoke to H, who said that this was still policy? I am not quite sure who’s policy?
I believe we must stop the hub sending Covid negative patients into our nursing homes. – until they are clear of infection. I also believe we cannot discharge anyone from our nursing homes without a clear swab.
I think if anyone were to be made aware that their relatives were being transferring into a Covid positive care home, where they will be at high risk of getting Covid, they would rightly be up in arms. They would rightly be up in arms because it is unsafe, it is putting staff and patients at risk. We already know that nursing homes are becoming the focus of Covid deaths, we should not be making this situation worse in nursing home X and Y.’
I am no genius. I was not the only one who could see that this was a stupid and deadly policy. I wrote about it, and complained about it, at the time. We have now had a court case saying what was done was illegal. But [squeaky voice] ‘no-one knew…’ The care home managers were all up in arms at the time. They bloody knew. But no-one chose to listen to their inconvenient truth.
So now what happens. It it almost impossible to see that anything of any value will occur as a result of this judicial health review. What lessons we be learned? None by the Department of Health and Social Care. Their comment:
‘A spokesperson for the Department of Health and Social Care, said: “We specifically sought to safeguard care home residents based on the best information at the time.’ Yup, safety was their number one priority.
Well, God only knows what would have been the result if they hadn’t decided to ‘specifically safeguard care home residents, based on the best information at the time.’ It is difficult to think of anything they could have done to make things worse.
‘The best information?’ Who gave them this information? The same vague unidentifiable entity who made the mistakes and will now be learning the lessons I suppose. Maybe it was the exact same god-like entity that was spoken of, in hushed tones, during the pandemic …The Science. Yes, The Mighty Science that works in mysterious ways, its wonders to perform.
Once upon a time I was a member of the General Practitioners Committee. A sub-committee of the British Medical Association that represents GPs. This was during a time when the Quality and Outcomes Framework (QOF) system was being rolled out. There is hardly anyone working in the NHS, including almost all hospital doctors, who has any idea what QOF is. But GPs [Family physicians] sure as hell do.
I donned my armour and battled against it, in a purely Don Quixote style. I was aware that I was tilting at windmills, but I felt the need to do something, however unlikely I was to succeed. This stance did offer the advantage that I could then say two things that really irritate other people. First ‘It wasn’t my fault.’ Even worse ‘I told you so.’
Ah yes, what on earth is he talking about this time? What is this QOF thingy, you ask? And what has it to do with evidence-based medicine? Well, you could say that QOF represents the inevitable end-point of evidence-based medicine. The crowning glory of a system designed to remove uncertainty from clinical practice. Replace it with carefully crafted treatment algorithms, based on the best possible evidence.
To explain in a little more detail. QOF itself is a system whereby GPs can earn points for reaching various targets. They are then paid money for each point gained. How much money? You can skip the next bit, but it makes me laugh. It is but the tip of a mighty iceberg of complexity. A system that makes filling in a tax return look like light-hearted fun.
‘To work out your actual QOF value for your practice, you need to divide your population by 8,479 to derive a factor and multiply this to the QOF point value to derive the actual QOF value for your practice.
For example, if your practice has 4000 patients.
4000/8479 = 0.4717537
0.4717537 x £187.74 = £88.57 per QOF point.’
At present it is possible to achieve a maximum of 567 points (last time I looked). This equates to an income of roughly fifty thousand pounds, for a practice of four thousand patients. If, that is, you achieve all the points on offer. Which is tricky.
What sort of activity earns points? Well, take diabetes as an example. You start by establishing, and maintaining, a register of all patients, aged seventeen or over, with diabetes. The register must also specify the type of diabetes – where a diagnosis has been confirmed.
You may think this all sounds perfectly reasonable, but then ask yourself why does it need to be done? In the UK, all GPs use computer systems. If someone has diabetes, this will be known. It will be on screen. It’s not as if the GP is going to be taken by surprise to learn that the patient has diabetes when they carry out an audit.
In short, an up-to-date list makes no difference to their management. Nor are you going to suddenly stumble across more patients with diabetes simply by the magical act of creating a list.
No, the reason why a list must be created is that you can gain points for such things as lowering the blood pressure to a ‘target’ level in the approved percentage of patients. Or driving the cholesterol level down below the ‘target level’, or getting the blood sugar (HbA1c) level below the ‘target’ level in the approved percentage of patients.
In short, for QOF to work, the GP needs to create database after database of different diseases. Then carry out audit … after audit. What a great use of clinical time it all is. Appointment after appointment filled with patients called in to have their annual blood pressure check, which just sneaks in just below target level – every single time.
For the pharmaceutical companies this is manna from heaven. Every patient with diabetes logged and audited. Every one driven to reach a ‘target’. A target that will inevitably require medication. Medication that the pharmaceutical company just, ahem, happens to have developed. Medication where they just, ahem, happen to have done all the clinical trials.
In addition to QOF, you also need to link everything into NICE guidelines. NICE stands for ‘The National Institute for Health and Care Excellence’. They produce magnificent ‘evidence based’ medical guidelines on such matters as the management of low back pain, or treatment of high blood pressure. Amongst a multitude of other things.
Some of these guideline documents are, literally, hundreds of pages long. But if you do not follow them then you are in trouble. You could find yourself struck off the medical register.
If you add NICE to QOF, what do you get?
What you get are extraordinarily rigid pathways, and algorithms, for treating patients. Soviet style central planning at its finest. Everything commanded from on high, everything measured, everything inspected. All five-year plans in place …comrade.
At this point you may well ask, why the need for highly trained clinicians? Disease X requires treatment Y, at dose Z, to achieve the desired outcome. Anyone sitting in front of a computer can do this. It requires no knowledge of why you are doing any of it.
Equally, it requires zero understanding of the complex relationship between various physiological systems, or the specific medical needs of a patient either. What if the patient has three different diseases, where you must balance one system against another? What if no-one has ever studied the use, benefit, or harms, of four different drugs given at the same time? How do you balance one set of guidelines against another?
Leaving such issues to one side, depending on your philosophy of life, you may believe this is all a fantastic idea. Repeatable and reliable treatment protocols replacing potentially flawed clinical judgement. Factory worker vs. skilled artisan. Ford vs Rolls Royce. In general, we know who usually wins this one. Command and control vs. individual decision making. No contest.
However, if the medical authorities decide, as they have done, to go down the bureaucratic ‘command and control’ model – based on the best evidence available – then there is a critical thing. It is the absolute requirement to be certain that the evidence you use is of the highest quality. Untouched by bias … if not, your house of algorithms simply collapses.
So, how reliable is the evidence base? Here is what Richard Horton (editor of The Lancet) stated a few years ago in an article ‘Has science “taken a turn towards darkness”?’
“The case against science,” wrote Richard Horton, editor of the medical journal the Lancet, “is straightforward: much of the scientific literature, perhaps half, may simply be untrue.”1
A while back I wrote a book called Doctoring Data, in which I tried to help people understand the many, many, ways in which the data from major clinical trials are manipulated and biased. How they are carefully designed to obtain only the desired results. I also attempted to clarify the endless data manipulations used to report the results themselves.
If I had to sum up the overall message of the book, it is that we are all, essentially, bunny rabbits caught in the headlights of an onrushing car. The onrushing car, in this case, being pharmaceutical company profits.
More recently the BMJ published an article entitled ‘The illusion of evidence-based medicine.’ 2
It begins, thus:
‘The advent of evidence-based medicine was a paradigm shift intended to provide a solid scientific foundation for medicine. The validity of this new paradigm, however, depends on reliable data from clinical trials, most of which are conducted by the pharmaceutical industry and reported in the names of senior academics. The release into the public domain of previously confidential pharmaceutical industry documents has given the medical community valuable insight into the degree to which industry sponsored clinical trials are misrepresented. Until this problem is corrected, evidence-based medicine will remain an illusion.’
It goes on to say:
‘Regulators receive funding from industry and use industry funded and performed trials to approve drugs, without in most cases seeing the raw data. What confidence do we have in a system in which drug companies are permitted to “mark their own homework” rather than having their products tested by independent experts as part of a public regulatory system? Unconcerned governments and captured regulators are unlikely to initiate necessary change to remove research from industry altogether and clean up publishing models that depend on reprint revenue, advertising, and sponsorship revenue.’
I have been saying this, or something pretty much like this, for years. As have many other voices … howling in the wilderness. Has anything changed? Well, yes, it has changed. It has all got considerably worse.
For example, much of the recent research done during the COVID19 pandemic was almost laughably biased and dreadful. Anything that could make a pharmaceutical company money was promoted ruthlessly – did someone say remdesivir. Anything where no little money could be made was slammed though the floor. Did someone say hydroxychloroquine?
As for the vaccine trials themselves. Let us draw a discrete veil over those …vague approximations to science.
What we currently have is a crisis in evidence-based medicine. The evidence that we use is, at best flawed and incomplete. At worst, just plain wrong. Yet, this is this evidence used to create the NICE guidelines and drive the QOF targets.
Any wonder so many GPs are completely fed up. It is not the only reason, but it is a major reason. ‘You trained me for ten years, now I cannot even make a bloody clinical decision. What is the point?’ A GP colleague calls it ‘monkey medicine.’ In that a well-trained monkey could do it.
When QOF was first being heavily promoted as the glorious future of primary care, I made a prediction. I predicted that life expectancy of the elderly (where most of the QOF points aggregate) would gently start to fall. This would happen because everyone was going to be monitored and measured. Then treated with drug after flawed ‘evidence-based ‘drug.
Two problems. First, this would inevitably drive polypharmacy [many different drugs prescribed simultaneously], and the evidence for this is overwhelming, and clear. Here is a short section from a paper examining the increasing use of multiple medications. ‘Medication usage change in older people (65+) in England over 20 years: findings from CFAS I and CFAS II.’
‘The number of people taking five or more items quadrupled from 12 to 49%, while the proportion of people who did not take any medication has decreased from around 1 in 5 to 1 in 13.’3
Polypharmacy is, in of itself, potentially dangerous, in that all the different drugs can start interacting with each other in unexpected and, often, damaging ways. Many studies have demonstrated this unequivocally. 4
These inherent problems with polypharmacy are, of course, made far worse by being driven by biased evidence. It does not take a genius to add two and two in order to predict that, in this situation, life expectancy may well go down, rather than up.
Biased evidence base + polypharmacy = increased morbidity and mortality
In support of this, here is an analysis from Imperial College London entitled ‘Life expectancy declining in many English communities even before pandemic.’
‘A substantial number of English communities experienced a decline in life expectancy from 2010-2019, Imperial College London researchers have found …For such declines to be seen in ‘normal times’ before the pandemic is alarming.’’ 5
Cause and effect? This cannot be said for certain – rather too many variables flying about. I know what I think.
However, one thing you can certainly argue is the following. If the evidence we now use to audit and treat everyone, using QOF, was of unbiased high quality, then you should expect to see some improvement in life expectancy.
But that is not what happened. What happened, was a fall. Not a huge, oh my God fall, but a fall, nonetheless. Has anyone pointed to QOF, and NICE, and the endless proliferation of guidelines as potential factors? You already know the answer to that one. Not a chance.
Whilst other countries do not have QOF, or NICE, the relentless march of evidence-based guidelines, and the subsequent clinical algorithms that they are based on, has become a world-wide phenomenon. The US, too, is seeing a fall in life expectancy.
At one time, long ago, I was a great believer in evidence-based medicine. It seemed like a good idea at the time. I now recognise that I was hopelessly naïve. First, as a student of history, I should have known that centralised command and control systems always end in disaster.
This happens, no matter how well intentioned it may have been to start with, and QOF was well intentioned. A crushing and inflexible bureaucracy will inexorably grow, and suffocate, and drain enthusiasm and energy from the workplace. The guidelines themselves would also, inevitably, end up as a Procrustean bed, upon which no patient can ever fit. So, you have to chop bits off, or stretch, as required.
Procrustes “the stretcher [who hammers out the metal]”, was a rogue smith and bandit from Attica who attacked people by stretching them or cutting off their legs, so as to force them to fit the size of an iron bed. [The process was always fatal].
In this case, the Procrustean bed has been further distorted by the fact that the evidence base itself rests of quicksand. It is a horribly biased mess. So, yes, evidence-based medicine was a good idea (sort of). It died long ago. R.I.P.
As an end-note, the impact of QOF was reviewed a few years ago. In 2017, to be precise. Nothing since that I am aware of. As the study concluded:
‘The lack of effect of the QOF on mortality is surprising, given that the indicators are based on high-quality evidence of effectiveness of interventions. Why this is the case is not clear…‘6
Not clear… There are none so blind as those who have not eyes to see.
Someone once said to me that I really must despise the pharmaceutical industry. There are certainly times when this is true, and my anger with them is sharp … and hot.
But yet, and yet, I know many people who work in the industry, and they all seem nice, concerned about the world, caring. Trying to do good. The industry itself has also produced some great innovations and medications. Without which the world would be a much scarier and more unpleasant place.
In truth, I find the industry is a bit like capitalism. Both fantastic and dreadful. Which is a bit like humanity itself. Both fantastic and dreadful. Capable of the most amazing things, yet the darker side can be very dark indeed. Dr Jekyll and Mr Hyde.
To be frank, my personal problems with the pharmaceutical industry have mainly centred around cholesterol lowering. Various companies have made billions, nay tens of billions, nay hundreds of billions, pushing LDL-Cholesterol reduction with all their might.
However, I have oft sat with my head in my hands in despair at such nonsense. Pfizer with Lipitor (atorvastatin) pushed the hardest and made the most … and horribly distorted the entire world of cardiovascular disease research in so doing.
However, thirty years ago, and purely by chance, the planets Pfizer and Kendrick were in a strange alignment. Briefly, I found myself on the same side as Pfizer when it came to cardiovascular disease.
How could this possibly be so? Well, gentle reader, let me take you back to a time when Pfizer had a very different drug to promote, called Doxazocin. It was a type of blood pressure lowering agent known as an Alpha-1 blocker. It was not selling terribly well, so they were looking for other angles in an attempt to boost sales.
I should mention that this was before Pfizer had a statin. A time that you could refer to as the ‘BS’ era. (Or maybe we are now in the true BS era – discuss). Then, in the year 2000, Pfizer took over Warner Lambert, which just happened to have a statin called atorvastatin (Lipitor). Yes, Pfizer didn’t actually develop atorvastatin. They just bought out the company that did. Nifty move.
Anyway, in 1992, Pfizer was not much interested in lowering LDL-Cholesterol, as they didn’t have a statin. Which meant they had other fish to fry with their cardiovascular drugs. They were more focussed on blood pressure lowering. But their Alpha-1 blocker for this, doxazocin (Cardura) was a bit rubbish.
So, what to do? What to do indeed. What they did was to use the tried and trusted mechanisms of looking at different effects that this drug might have.
To explain, almost all drugs when they are launched are marketed for one indication, and that indication only – the thing that will make the most money. Achieving marketing approval, for any indication e.g., blood pressure lowering, costs vast sums of money. Which means that companies must keep their focus tight, to drive the drug through the clinical trials process.
However, almost all drugs will do many other things, and you cannot run separate clinical trials on them all. To long, too complex, too costly.
There may be some ‘magic bullet’ drug that hits one target, and one alone, and spares everything else. Sniper fire. However, with most of them, you select automatic, raise the gun over your head from behind a sheltering wall, close your eyes, and spray bullets vaguely towards the target. Hoping you manage to hit the thing you’re aiming at.
Just to give a few well-known examples from history. Aspirin was initially found to reduce pain, inflammation and temperature. It was later discovered it helps to prevent platelets (small blood cells) sticking together. So, it was also an anti-coagulant – it reduced the risk of blood clots forming – and thus reduced the risk of dying of a heart attack. Now, it is being used to prevent cancer.
Sildenafil (Viagra) was initially developed as a drug for angina. The rest, as they say is history. It ended up being marketed for erectile dysfunction because it had an unknown, at the time, ‘off-target effect’ that had nothing, directly to do with angina at all. Or, at least, no-one could see the connection at the time.
Thalidomide was originally developed as a sedative. It was then sold for treating colds, flu, nausea and morning sickness. As everyone now knows, it caused horrible deformities in the unborn child.
Coincidentally, it was discovered the very same mechanism that led to the terrible deformities, also meant it was pretty good at treating a whole series of different diseases, such as multiple myeloma and leprosy. It is now prescribed as Thalomid – it has many different names. But certainly not thalidomide.
Last time I bothered counting, statins had thirty-four off-target effects. These are sometimes called ‘pleiotropic’ effects. I suppose this makes them sound more scientific. I am only surprised that statins have not yet been repurposed as anti COVID19 drugs. Probably because they are all off-patent, thus cannot make vast sums of money.
In an attempt to pull all these strands together, if your drug is not selling that well, have a closer look at all the other things it may do. The off-target effects, the ‘pleiotropics’. It has already reached market, at great cost, and whilst you are not allowed advertise it for ‘off-label’ benefits i.e., benefits not studied in the clinical trials, you can hold educational meetings and produce educational booklets to promote these additional things.
You can, effectively, launch it again as ‘Cardura two point one’. Ladies and Gentlemen …. drum roll. ‘A new era in cardiovascular disease prevention has begun.’ Dun, dun, duuuuuuuuun!’
At which point you can purchase a few off the shelf cardiology opinion leaders to push Cardura two point one with great enthusiasm. Throw a few million – carefully labelled – free pens, sticky pads, and BP cuffs around as an appreciative gift to doctors. Take them to a free lunch, sorry, educational meeting. Bore them for ten minutes, then reward them with a prawn sandwich. Feed the sea-lions.
And lo it came to pass that Pfizer scrutinised Cardura in greater detail, and found that it, like aspirin, helped to stop platelets sticking together. Platelets are small cells that float around in the bloodstream and play the key role in blood clotting. They have been described as the conductors of the clotting orchestra.
If you stop platelets sticking together, you can reduce the risk of cardiovascular disease, as was discovered with aspirin. Aha! So, not only does Cardura lower blood pressure, but it also has ‘anti-coagulant’ properties. Even better, it reduced fibrinogen, and PAI-1 and increased TPa activity. These are all ‘good’ in reducing the formation and increasing the breakdown of blood clots. As Pfizer stated:
‘These recent studies suggest that doxazosin may have a range of significant antithrombotic effects in many patients…’
Unfortunately, in 1992 doctors had already been under heavy and continuous bombardment with the message that lowering cholesterol and blood pressure were, by far, the most important things you could possibly do to prevent cardiovascular disease.
Blood clotting? Well, aspirin was used, a bit. But this was mainly to help with the final event. The big blood clot that blocked a major artery. No-one was suggesting that blood clotting had anything to do with atherosclerosis itself.
After all, how can blood clotting possibly cause atherosclerotic plaques to develop? As everyone had already been told, and told, and told … and told, and then told some more, atherosclerotic plaques (the entities that gradually grow and narrow down arteries) were full of cholesterol. Not the remnants of blood clots.
Love and marriage may go together like a horse and carriage, but platelet aggregation and atherosclerotic plaques …. You certainly cannot get a rhyme out of that – go on, I challenge you. Ergo, it must be wrong.
It was certainly a big mountain to climb. ‘You know that stuff about cholesterol…. Sorry. Turns out we should have been looking at Platelets and blood clotting instead.’ Here from a booklet on Cardura in 1992:
Platelets and atherosclerosis progression
Several features of mature plaques, such as their multi-layered pattern, suggest that platelet aggregation and thrombus formation are key elements in the progression of atherosclerosis. Platelets are also known to provide a rich source of growth factors, with can stimulate plaque development.
Given the insidious nature of atherosclerosis, it is vital to consider the role of platelets and thrombosis in this process, and the serious events that may be triggered once plaques are already present.
Goodness me. Who said all this? Why, of course it was Pfizer … Pfizer, Pfizer, Pfizer.
However, they didn’t get very far with this story. Merck were hammering away with simvastatin (Zocor) and Bristol Myers Squibb were also promoting pravastatin (Pravachol) with relentless fervour. The world of cardiovascular disease prevention was moving even more firmly in the direction of cholesterol lowering and statins.
As King Cnut (Canute to you and me) once demonstrated, once the tide starts to come in, not even a king can stop it. And the statin wave was very powerful. On the basis that, if you can’t beat them, join them, Pfizer decided to ride that wave. So, they went out and bought a large part of it, then bought the surf-boards and the tinnies.
To their (money making) credit, they then rode the cholesterol wave exceptionally well. To be frank you would buy a used car from Pfizer. I don’t know how they got so brilliant at spraying bull-shit with yellow paint, to make it look like one-hundred per-cent gold bullion, but there is no doubt they are the masters of pharmaceutical marketing.
At which point the Kendrick and Pfizer, planets were no longer in alignment. We span off on different orbits. I was still slowly plodding along the ‘platelets and atherosclerosis progression’ path, trying to make sense of it all.
Pfizer, to flip my analogies, firmly jumped on the ‘all singing, all dancing’ cholesterol lowering bandwagon.’ Complete with dancing girls in fancy costumes, a brass band, champagne, hundreds of balloons – and all the key opinion leaders in cardiology singing ‘We’re in the money.’
We’re in the money
We’re in the money
We’ve got a lot of what it takes to get along
We’re in the money
The sky is sunny
Old man depression, you are through you done us wrong, oh
We never see a headline
‘Bout a breadline today
And when we see the landlord
We can look that guy right in the eye
Oh, We’re in the money
Come, on my honey
Let’s lend it, spend it, send it rolling around…
And lo it came to pass that Pfizer and I were no longer friends. But there was a time when I like to think we could have danced all night, and still have begged for more. I could have spread my wings, and done a thousand things, I’ve never done before. Yes, my bandwagon would have been much better. Better music too. John Martyn, Fleetwood Mac, Randy Newman, The Pretenders, Jools Holland ….
Yes, it’s a little bit funny that Pfizer knew, thirty years ago, that blood clotting and atherosclerosis were intimately connected. They had seen the research. They knew:
‘Important evidence is now emerging that the selective alpha-1 inhibitor, doxazosin, in addition to its beneficial effects on elevated blood pressure and the serum lipid profile, may help to intervene in the evolution of thrombosis, a key component of atherosclerosis.’
In my recent book The Clot Thickens, I said I would put up the Pfizer booklet for all to see. It proved a bit more of a technical challenge than I thought, but here it is. And when people tell me that atherosclerotic cardiovascular disease (ASCVD) is all due to raised cholesterol I can say, not even Pfizer believes that. Not really. Not deep in their hearts …. They have a ghost in the machine that still stalks the corridors of Pfizer HQ. And if it doesn’t, it should.
They knew, oh yes once upon a time, they knew. It’s just not very profitable for them to admit it. To quote John Martyn:
‘Half the lies I tell you are not true.’
Introduction
To date, most of our attempts to prevent atherosclerosis have centered on the control of hypertension and hyperlipidaemia, as well as lifestyle factors . However, recent insights into the pathology of coronary heart disease have sharpened our focus on the natural history of atheroma and its relentless progression to acute cardiac events.
Platelets and atherosclerosis progression
Several features of mature plaques, such as their multi-layered pattern, suggest that platelet aggregation and thrombus formation are key elements in the progression of atherosclerosis. Platelets are also known to provide a rich source of growth factors which can stimulate plaque development.
Given the insidious nature of atherosclerosis, it is vital to consider the role of platelets and thrombosis in this process, and the serious events that may be triggered once plaques are already present.
Fibrinolysis
If fibrinolysis is incomplete, thrombus may become incorporated into the plaque, and may cause severe stenosis. Alternatively, any residual thrombus can act as a powerful stimulant to further platelet aggregation. The growing mass of fibrin, platelets and enmeshed red cells may become solid enough to cause complete vessel obstruction.
It is significant to note that complete obstruction and myocardial infarction often develops from mild lesion initially causing less than 50% stenosis. Rupture of these plaques and the cascade of events that leads to thrombosis can occur rapidly and it now recognized as a common and major precipitant of unstable angina, myocardial infarction and sudden cardiac death. Studies suggest that thrombotic events may account for up to 90% of acute myocardial infarction.
Triggering factors in thrombosis
Hypertensive patients are known to have greater platelet adhesiveness and aggregability, which could increase clot formation at the site of plaque injury. In addition, thrombolysis is often defective in hypertension and hyperlipidaemia, which may result in an impaired ability to dissolved clots in the presence of atherosclerosis.
Clot propagation
Any residual thrombus can act as a powerful stimulant to further platelet aggregation. The growing mass of fibbing, platelets and enmeshed red-cells may become solid enough to cause complete vessel obstruction.
It is significant to not that complete obstruction and myocardial infarction often develops form mild lesions initially causing less than 50% stenosis. Rupture of these plaques and the cascade of events that leads to thrombosis can occur rapidly and it now recognized as a common and major precipitant of unstable angina, myocardial infarction and sudden cardiac deaths. Studies suggest that thrombotic events may account for up to 90% of acute myocardial infarctions.
The atherosclerotic process begins with infiltration of low-density lipoproteins or LDL into the arterial intima to create lipid-rich foam cells which form the basis of the ‘fatty streak.’ This early lesion contains large amounts of cholesterol, but its development to atherosclerosis is not inevitable. Progression appears to depend critically upon endothelial injury, caused by oxidation of LDL by the shearing forces of hypertension and by smoking.
Conclusion
With each decade, new insight is gained into how drug therapy can reduce the risk of coronary heart disease and stroke, the primary goal in the management of the hypertensive patient. Important evidence is now emerging that the selective alpha-1 inhibitor, doxazosin, in addition to its beneficial effects on elevated blood pressure and the serum lipid profile, may help to intervene in the evolution of thrombosis, a key component of atherosclerosis.
The Document is called Pathological Triggers ‘New Insights into Cardiovascular Risk.’
Produced by Medi Cine Inc 488 Madison Avenue New York NY 10022
For Pfizer Inc New York NY 10017 Copyright 1992 Pfizer Inc. All rights reserved.
Ivor Cummins [not Cummings please Mr spell check] has organised an on-line meeting on the 9th of April. Ivor is a brilliant man. He must be, he asked me to give one of the talks. He has brought together a great list of presenters who have been innovative thinkers in the world of cardiovascular disease for many years.
We are all, in different ways, trying to break out of the suffocating embrace of the ‘diet-heart cholesterol hypothesis’ and move things along. Our focus and thoughts are not exactly the same – thank goodness. Ivor is highly focussed on the metabolic causes of heart disease. Essentially insulin resistance, type II diabetes and suchlike.
Others have been researching the microbiome and related issues. However, the approaches are all complementary. Those who have read my stuff will know that there is not one cause of heart disease, there are many. Equally, you are not going to protect yourself against heart disease doing one thing. You need to do many.
The purpose of this conference is to look at many different areas, and many different approaches, to discuss how each of them can provide benefit. The synergies that you can find. There is also an opportunity to discuss your specific questions with the presenters. I hope this conference will be the first of many.
Dr. Malcolm Kendrick 