12th January 2023

Taking a small detour for the moment, I thought I would try and look at bit more closely at corruption. How do you define it? What is it? I believe if you are going to defeat something, you first need to understand what it is. Know thine enemy, as they say.

I began by looking up the word corruption in a dictionary, which defined it thus:

Corruption: ‘dishonest or fraudulent conduct by those in power, typically involving bribery.’

However, that is not really what I think of, when I think of corruption. An occasional trip to the theatre, or nice meal in a restaurant from time to time. Whilst imperfect, actions like this are not enough to constitute a major problem.

Corruption, to me, is when the entire system is taken over. Where almost everyone either takes part, or instead chooses to remain silent. At which point no actions can be trusted.

This is the situation that developed within FIFA (Fédération internationale de football association meaning International Association Football Federation) under Sepp Blatter’s leadership. Where hosting the football World Cup became an exercise in bribery from which no-one, and nothing, was immune.

Any man, or woman, who refused to take a bribe from FIFA was the exception, not the rule. Envelopes stuffed with cash were handed out in hotel rooms. At which point we had a completely corrupt organisation. Which is bad enough, on a relatively small scale, in an organisation that deals only with football.

On a larger scale, what happens when corruption affects everything? According to a global corruption index, the worst five countries in the world for corruption are:

• Syria
• North Korea
• Congo, Dem. Rep
• Yemen
• South Sudan

The lowest five ‘risk’ countries for corruption are – starting with the best:

• Norway
• Finland
• Sweden
• Denmark
• Estonia

It is no coincidence that the quality of life, and the wealth and happiness of people in these countries, indeed every country in the world, is closely tied to how corrupt those countries are. Indeed, the association between corruption, and quality of life, moves virtually in lock-stop.

Which means that corruption represents one of the gravest problems humanity faces. The worse it becomes, the more everything else falls apart. Given time, it eventually eats out the very structures that allowed it to exist in the first place. See under “The Roman Empire”.

Moving onto the bribery part of corruption. I also believe that bribery is about far more than just money. Whilst money represents the most obvious way to ‘bribe’ people. there is also power.

I quote you, Frank Underwood, the main fictional character in House of Cards.

‘Such a waste of talent. He chose money over power. Money is the Mc-mansion in Sarasota that starts falling apart after 10 years. Power is the old stone building that stands for centuries. I cannot respect someone who doesn’t see the difference.’

Then there is status. To stand tallest amongst your peers.

‘A good reputation is more valuable than money.’ Publilius Syros.

Nelson Mandela was uninterested in money, but at one time he was probably the most influential and highest status man in the world. Not, I hasten to add, that I think Nelson Mandela was in any way corrupt. But had he chosen to be …

Whilst it is difficult to define corruption perfectly, I would try to define it as … people doing things that are ‘paid’ for by others. Those who are paid gain what they greatly desire. Status, reputation, authority, power – all the same sort of thing, but not quite. And, of course, money. Those paying also gain what they want – usually more money.

For a system to be considered ‘corrupt’ a large number of those within it must take part. Those not actively taking bribes are also complicit, in that they have chosen to do nothing about it. They put up and/or they shut up. Worst of all, I think, is when they try to excuse it.

Money

Sticking to money for the moment and directing the discussion more specifically to the medical world. There was a time when the pharmaceutical industry was happy to pay doctors, and researchers, directly. Straight into the old bank account. No questions asked. Kerrching!

We would like you to give a lecture. Ten grand…kerrching! We want you to chair a think tank on the use of drugs in rheumatoid arthritis. Twenty grand … kerrching! We would like you to act as a consultant over the next two years in order to assist in our drug development programme. Fifty grand a year … kerrching! Run a clinical trial (put your name up as one of the main authors anyway). Don’t worry, you won’t actually have to write anything – or probably even read it. Two hundred grand … kerrching!

Or, taking a real-world example, let us have a look at Oxford Professor Sir Richard Doll. This is the man who, along with Bradford Hill, proved that smoking causes lung cancer. He is a hero to many within the medical profession.

As it turns out he was also paid $1,500 a day, for twenty years, by Monsanto. Which is a total of eleven million dollars. Kerrching!

At one point the Chemical Manufacturers Association, along with Dow Chemicals and ICI, dropped £15K into his bank account. This was for a review which cleared vinyl chloride of causing cancer – of any kind. This review was then used to defend the use of this chemical – now well recognised to be a cancer-causing agent – for over a decade.¹

In addition:

‘While he was being paid by Monsanto, Sir Richard wrote to a royal Australian commission investigating the potential cancer-causing properties of Agent Orange, made by Monsanto and used by the US in the Vietnam war. Sir Richard said there was no evidence that the chemical caused cancer.’

How does that make you feel? I have to say I was disappointed, to say the least. Up until this revelation I thought he was one of the good guys. A benevolent, Nelson Mandela-like figure:

However, following these revelations, he was not criticised. Instead, he was robustly defended – which I take as a key signal that corruption has taken over the system:

‘Professor John Toy, medical director of Cancer Research UK, which funded much of Sir Richard’s work, said times had changed and the accusations must be put into context. “Richard Doll’s lifelong service to public health has saved millions of lives. His pioneering work demonstrated the link between smoking and lung cancer and paved the way towards current efforts to reduce tobacco’s death toll,” he said. “In the days he was publishing it was not automatic for potential conflicts of interest to be declared in scientific papers.’

It might not have been automatic to declare conflicts of interest Professor Toy. But that does not make it right. If you are paid tens of millions by the industry, you are no longer a disinterested scientist, and you cannot pretend otherwise. It was wrong at the time, just as it is now, as it always will be. [Nowadays conflicts of interest are far more carefully hidden away].

There were other defenders, from Oxford University.

‘Yesterday, Sir Richard Peto, the Oxford-based epidemiologist who worked closely with him, said the allegations came from those who wanted to damage Sir Richard’s reputation for their own reasons. Sir Richard had always been open about his links with industry and gave all his fees to Green College, Oxford, the postgraduate institution he founded, he said.’

This statement was from the same article which began with these words

‘A world-famous British scientist failed to disclose that he held a paid consultancy with a chemical company for more than 20 years while investigating cancer risks in the industry.’

So it seems, Sir Richard Peto, that Sir Richard Doll was not open about his links with industry. Not in the slightest. No-one in the wider world had the faintest idea. Did those in Oxford University really know? If so, did they actually condone his work on Vinyl Chloride and Agent Orange? They certainly did not breathe a word of criticism.

Instead, we get … ‘the allegations came from those who wanted to damage Sir Richard’s eruption for their own reasons.’ In short, it is those making the allegations who are the bad guys. See under … children accusing priests of sexual abuse in the early days. ‘How dare evil children accuse these noble men of such things?’ Such things that they actually did, you mean.

And what reason could anyone have for damaging the reputation of man who was already dead, with these terrible ‘allegations?’ None was given, because there are no such reasons. Also, these were not ‘allegations’, they were facts. What should they have done, kept their mouths shut?

No, here is what those who worked with Sir Richard Doll should have said, or something very like it.

‘Sir Richard Doll did highly important work in proving that cigarettes cause lung cancer. Work that has benefitted hundreds of millions. However, he took large sums of money from commercial companies and then wrote papers in support of those companies, which resulted in a great deal of harm. We cannot condone these actions. This has seriously damaged his reputation, as it should. We will work to ensure that this type of situation never happens again.’

However, it seems that if you are seen as a ‘great’ person, who has done great work, you cannot possibly be accused of corruption. Even if the evidence is laid out before us all, in black and white.

Perhaps you think I am being rather harsh here. Focussing my attack on one ‘great’ man, now dead. In truth, I picked on this case for a couple of reasons. First, I want to make it clear that corruption is not a new thing in medical research – although it has greatly worsened – and gone undercover. Second, I hope to make it clear that those with a reputation for doing ‘great work’ are just as likely to be corrupt as anyone else.

In truth, they are the most likely to be corrupt. How so? Because they have achieved such high status that they have risen beyond suspicion. In addition, the ‘great ones’ have made themselves immensely valuable. Which means that they are actively sought out. They have both status, and influence.

Authority = power = influence

Influence ↔ money.

Influence is the currency here. And currency is very easily converted into money, and back again. If you can find the most influential ‘great person’ or ‘great institution’ or great ‘great medical journal.’ You pay them the money, and you get the influence you desire.

‘Sir Richard Doll himself says that vinyl chloride is perfectly safe, and how dare you argue with him – you pathetic nobody.’

Or, to quote the industry view on such matters:

‘Key Opinion Leader is regarded as the mastermind in the pharma industry. They’ve put in the time and research to be recognized by their peers as experts in their field. As a result, they have gained a reputation as a thought leader within their specific niche. Their expert opinions and actions can significantly affect the adoption of a new product/brand or the ability to influence consumer purchasing decisions.

Key Opinion Leaders are sort of like the avengers of the clinical research world. They can fill many different roles, and their skill sets are highly sought after by those in the know. A key opinion leader can be critically important in helping to educate physicians about a new drug. They can provide information about the working of drugs, which patient demographics can benefit the most, and what treatment regimens are most effective. KOLs can also offer their unique insights as early adopters of new therapies, which can help to identify and create brand acceptance in healthcare.’²  

Nowadays there are entire companies dedicated to nurturing and developing Key Opinion Leaders and helping them work with pharmaceutical industry. Or vice-versa. Here, from the horse’s mouth. An article entitled: ‘KOL management in Pharma and Life Sciences.’

‘As pharmaceutical and life-sciences companies search for the most effective, efficient ways to manage collaboration with the physicians who conduct research, write articles, or speak on their behalf, relationship management of the interaction with these elite physicians, or key opinion leaders (KOLs), has ultimately emerged as an individual business discipline. Similar to CRM, KOL management is an essential component for marketers and medical staff throughout the life-cycle process of a specific drug or product.

By sustaining a business process that creates and maintains meaningful and collaborative relationships between KOLs and business functions from marketing to medical affairs, pharmaceutical and life-sciences companies can experience increased share of voice and accelerated adoptions at the global, national, and regional levels. A CEO of a major pharmaceuticals company recently told a group of analysts that effectively managing KOL relationships was essential to companies’ future products and market expansion.’ ³

Today, almost all of the great people (Key Opinion Leaders), institutions, medical societies and medical journals have been captured by the industry – to a greater or lesser extent. As far back as 2009, the long-time editor of the New England Journal of Medicine wrote these words. Words that I have quoted several times before, but they need almost endless repetition.

‘It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.’

What happened following this scathing attack? Nothing. Yet these words come from the editor of the most influential (highest impact factor) journal in the World. Someone who spent her entire working life reviewing the quality of medical research, assessing how robust medical guidelines are, and how trustworthy our ‘trusted’ physicians might be.

The answers to those questions being ‘rubbish’, ‘biased’ and ‘corrupt’ in that order.

I have occasionally asked myself: “What would be the worst effect of corruption of medical research”? Well, there are the obvious things. First that we cannot believe a damned thing that is published. With certain provisos – there are honest researchers out there.

Equally bad, or perhaps worse, doctors end up prescribing medicines that do no good, and possibly do harm. Based on biased physicians running biased trials, followed up by biased guidelines, to be published in biased journals.

These are, of course, in themselves terrible things.

But there is something else, which may actually be worse in the long run. If research is directed almost entirely towards ideas that support commercial goals, then this will end up crushing work that dares look in different directions. Try publishing a paper suggesting that cholesterol lowering is a waste of time, when the market for cholesterol lowering drugs is worth hundreds of billions.

Yes, you may be lucky enough to get something into a lower impact journal, but the bigger journals will block you completely. Come up with a different hypothesis as to what actually causes cardiovascular disease, and the big journals will not touch it with a bargepole.

Science only lives, and progresses, when the status quo is regularly attacked, and disrupted. But within a corrupt system, where the majority of funding comes from commercial sources, innovation grinds to a halt. Primarily because new ideas threaten profit. Try stating that Type II diabetes can be reversed with exercise and a low carbohydrate diet, and you are threatening a $200Bn market for diabetes medications. So, good luck with that.

Which leads me to perhaps the most soul-destroying article I have read recently. It was a review of disruptive science. By which the authors meant, the degree to which a scientific paper shakes up the field.

‘The authors reasoned that if a study was highly disruptive, subsequent research would be less likely to cite the study’s references, and instead cite the study itself. Using the citation data from 45 million manuscripts and 3.9 million patents, the researchers calculated a measure of disruptiveness, called the ‘CD index’, in which values ranged from –1 for the least disruptive work to 1 for the most disruptive.

The average CD index declined by more than 90% between 1945 and 2010 for research manuscripts (see ‘Disruptive science dwindles’), and by more than 78% from 1980 to 2010 for patents. Disruptiveness declined in all of the analysed research fields and patent types, even when factoring in potential differences in factors such as citation practices.’

Just have a look at the graph ⁴:

It is hard to think of a more depressing graph. Looking specifically at life sciences and biomedicine – otherwise known as medical research. It would seem that since the mid-1990s there has been virtually no disruptive science published – at all, anywhere.

The article itself states that ‘disruptive science has declined – and no-one knows why?’

Well, to my mind, there are two possibilities for this decline. The first is that we now know virtually everything across all scientific fields. Therefore, disruptive science has inevitably declined, because there is nothing new to be discovered. We simply know it all.

Of course, this echoes a famous comment by Lord Kelvin at the end of the nineteenth century. ‘There is nothing new to be discovered in physics now. All that remains is more and more precise measurement.’ Ahem, have you come across this chap Einstein by any chance?

The second possibility is that some factor, we shall call it factor K (for corruption) has virtually taken over science, particularly medical science. This factor when combined with money, factor M, has the effect of destroying innovation (I). Thus, squashing disruptive research (DR) flat.

The equation is simple. I ÷ (K x M) = DR

Innovation, divided by (corruption multiplied by money) = Disruption Index.

As the flow of industry money into research has multiplied, innovation and new ideas have shrivelled and died. This, anyway, is my working hypothesis. You may feel there are other reasons. In which case, I would be interested to hear them.

So, yes, I think that corruption is incredibly important. Particularly within the world of science, where mavericks and innovators are absolutely essential. Graphene, for example, an actual major scientific breakthrough. This was discovered by two scientists, Andrei Geim and Kostya Novoselov playing about with pencils and sticky tape in a laboratory in Manchester University.

Playing about in a lab! Research nowadays is driven by funding. Funding is driven by commercial applications. The ‘best’ researchers today know how to bring in money for their labs, and for their universities. Today, researchers need to be productive and drive the income stream. To quote Peter Higgs: ‘I wouldn’t be productive enough for today’s academic system.’

‘Peter Higgs, the British physicist who gave his name to the Higgs boson, believes no university would employ him in today’s academic system because he would not be considered “productive” enough.

The emeritus professor at Edinburgh University, who says he has never sent an email, browsed the internet or even made a mobile phone call, published fewer than 10 papers after his ground-breaking work, which identified the mechanism by which subatomic material acquires mass, was published in 1964.

He doubts a similar breakthrough could be achieved in today’s academic culture, because of the expectations on academics to collaborate and keep churning out papers. He said: “It’s difficult to imagine how I would ever have enough peace and quiet in the present sort of climate to do what I did in 1964.’ ⁵

‘Collaborate and keep churning out papers.’ This is the Henry T Ford school of research. We need more research! Quantity is what matters. Churning out papers requires money. To get money we have to sell … ourselves.

But innovative research, disruptive research, is not about quantity. It is about quality. One paper on subatomic materials acquiring mass. This is worth an infinite number of papers on how wonderful statins are. But an infinite number of papers on statins is what we now get.

Today, universities sell themselves on their collaboration with industry. Opinion leaders are hugely valuable to the industry, and therefore to their universities. They cannot afford to consider doing research which threatens the flow of money. So, they don’t.

This has become the medical research world that we live in today. It is no longer innovative, disruptive, or challenging. It is almost entirely bought and paid for. It has become Zombie Science. To quote Bruce Charlton, once again, from his paper. ‘Zombie science: a sinister consequence of evaluating scientific theories purely on the basis of enlightened self-interest.’

In the real world it looks more like most scientists are quite willing to pursue wrong ideas for so long as they are rewarded with a better chance of achieving more grants, publications and status. The classic account has it that bogus theories should readily be demolished by sceptical (or jealous) competitor scientists. However, in practice even the most conclusive ‘hatchet jobs’ may fail to kill, or even weaken, phoney hypotheses when they are backed-up with sufficient economic muscle in the form of lavish and sustained funding. And when a branch of science based on phoney theories serves a useful but non-scientific purpose, it may be kept-going indefinitely by continuous transfusions of cash from those whose interests it serves.’ ⁶

When the journal Nature notes that disruptive science has declined, and no-one knows why … I think this is utter balls. There are plenty of people who know why. The journal Nature also probably knows why. However, if they were to say why, it would open the door to something so big and ugly that no-one wants to even look at it, let alone deal with it.

Better to keep that door firmly shut. That door to the Zombie room. The place where undead science roams. Where innovation, disruption and science itself … died. In the end corruption consumes the host.

1: https://www.theguardian.com/science/2006/dec/08/smoking.frontpagenews

2: https://viseven.com/key-opinion-leaders-in-pharma/

3: KOL Management in Pharma and Life Sciences (destinationcrm.com)

4: ‘Disruptive’ science has declined — and no one knows why (nature.com)

5: https://www.theguardian.com/science/2013/dec/06/peter-higgs-boson-academic-system

6: https://pubmed.ncbi.nlm.nih.gov/18603380/

10th December 2022

[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.

1: https://www.reuters.com/article/us-boeing-737-max-ceo-severance-idUSKBN1Z92DQ

2: https://eu.usatoday.com/story/news/nation/2019/04/20/did-faa-outsource-air-safety-boeing-and-other-companies/3497255002/

3: https://ethics.harvard.edu/blog/new-prescription-drugs-major-health-risk-few-offsetting-advantages

4: https://www.boeing.com/principles/values.page

18th July 2022

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.’

1: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4125239

2: https://twitter.com/gmb/status/1357600088617611266?s=21&t=giXjno9w9ksPRjItQhC9_w

3: https://www.bmj.com/content/377/bmj.o1538

3rd February 2019

A number of people have asked for my views on the Lancet Paper ‘Efficacy and safety of statin therapy in older people: a meta-analysis of individual participant data from 28 randomized controlled trials.’

It was reported in various major newspapers.

The Times reported the study thus: “Everyone over the age of 75 should be considered for cholesterol-lowering statins, experts have urged, after an analysis found up to 8,000 lives a year could be saved.”¹  

The Telegraph had this to say. “Researchers said up to 8,000 deaths a year could be prevented if GPs simply prescribed drugs costing pennies a day.”

This comes hot on the heels of a concerted effort to silence statin critics around the world by a coalition of ‘experts. I suspect the coordinated timing is more than a coincidence.

‘The editors of more than two dozen cardiology-related scientific journals around the world published an editorial Monday to “sound the alarm that human lives are at stake” because of medical misinformation.

These physicians describe regularly encountering patients hesitant to take potentially lifesaving medications or adhere to other prescribed treatments because of something they read online. Or heard from friends. Or saw on television.

“There is a flood of bad information on the internet and social media that is hurting human beings,” said Dr. Joseph Hill, the architect of the essay and editor-in-chief of the American Heart Association journal Circulation. “It’s not just an annoyance, this actually puts people in harm’s way.”

The primary example illustrated in the editorial is the use of statins, a cholesterol-lowering medicine that can reduce heart attack and stroke risk in certain people. But doctors say too many of their patients shun taking statins because of bad information they picked up – often from politicians, celebrities and others who lack medical expertise.’²

Essentially, they feel that certain issues, such as prescribing statins, are so vitally important that critics should be silenced. Perhaps all these editors should try reading this:

‘Congress shall make no law respecting an establishment of religion or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances.’

Yes, the US founding fathers knew the first thing tyrannies always wish to do is remove freedom of speech. From that, all else follows. If they don’t get that message, they should all be forced to read 1984 by George Orwell.

“Freedom is the freedom to say that two plus two make four. If that is granted, all else follows.”

Getting back to the Lancet paper. What do I think of it? The first thing to note is ‘who done it.’ Well, of course, it was the Cholesterol Treatment Triallists Collaboration (CTT) from Oxford. Run by Professor Sir Rory Collins and Professor Colin Baigent. They do almost all these meta-analyses on statins, because they hold all the data. So, no-one else can really do them.

The CTT is in this hallowed position because they made a pact with the dev… sorry … they made a pact with the pharmaceutical industry to take hold of all the data on statins from all the pharmaceutical companies that manufacture statins and collate the data.

The CTT are very closely associated with the Oxford Clinical Trials Service Unit (CTSU) which is run by, and has employed, most of those in the CTT. Collins and Baigent etc. The CTSU is a clinical trials unit which, last time I looked, had obtained nearly £300 million in funding from the pharmaceutical industry for running clinical trials on various cholesterol lowering medications.

A fact that needs to be emphasised is that the CTT will not let anyone else see the data they hold. Including all the data on adverse events [side-effects] and serious adverse events. It is kept completely secret. I have the e-mail exchange between an Australian journalist and Professor Colin Baigent where the journalist attempts to find out if it is true that the CTT will not let anyone else see the safety data.

It starts quite well and the tone is amiable. Eventually Professor Colin Baigent clams up and refuses to answer any further questions. I have promised said journalist to keep this exchange under wraps, but almost every day I am tempted to publish it. It is toe-squirming.

Anyway, my point here is that the CTT is a horribly conflicted organisation, and has been paid, directly, or indirectly, a great deal of money by the pharmaceutical industry. Here are the conflicts of interest of those involved in writing the Lancet paper:

Conflicts of interest of statement from the Lancet paper: Commercial organisations in bold.

RO’C, EB, IF, CW, and JS have nothing to disclose. JF reports personal fees from Amgen, Bayer, Pfizer, Boehringer Ingelheim, Sanofi, and AstraZeneca, outside the submitted work; and non-financial support from Amgen, Bayer, and Pfizer, outside the submitted work. BM reports grants from the Medical Research Council, British Heart Foundation, and the National Institute for Health Research Oxford Biomedical Research Centre during the conduct of the study, and grants from Merck outside the submitted work. CR report grants from the Medical Research Council and British Heart Foundation during the conduct of the study; and grants from Merck, outside the submitted work. JE reports grants from the Medical Research Council and the British Heart Foundation during the conduct of the study, and a grant from Boehringer Ingelheim outside the submitted work. LB reports grants from the Medical Research Council and the British Heart Foundation during the conduct of the study. MK is an employee of a company that has received study grants and consulting fees from manufacturers of PCSK9 inhibitors and treatments for lipid disorders, outside the submitted work. AT reports personal fees from Amgen and Sanofi, outside the submitted work. PR reports a research grant from AstraZeneca during the conduct of the study; and research grants from Novartis, Pfizer, and Kowa, outside the submitted work. CP reports a grant from Merck, outside the submitted work; and personal fees from Merck, Pfizer, Sanofi, Amgen, and Daiichi-Sankyo, outside the submitted work. EL reports grants from AstraZeneca, Bayer, Boehringer Ingelheim, Amgen, and Merck, outside the submitted work; and personal fees from Bayer, Amgen, Novartis, and Sanofi, outside the submitted work. WK reports grants and non-financial support from Roche, Beckmann, Singulex, and Abbott, outside the submitted work; and personal fees from AstraZeneca, Novartis, Pfizer, The Medicines Company, GlaxoSmithKline, Dalcor, Sanofi, Berlin-Chemie, Kowa, and Amgen, outside the submitted work. AG reports personal fees from Aegerion Pharmaceuticals, Arisaph Pharmaceuticals, DuPont, Esperion Therapeutics, Kowa, Merck, Roche, Vatera Capital, ISIS Pharmaceuticals, Weill Cornell Medicine, and Amgen, outside the submitted work. SY reports a grant from AstraZeneca, outside the submitted work. RC reports support from the Nuffield Department of Population Health, during the conduct of the study; grants from the British Heart Foundation, Cancer Research UK, Medical Research Council, Merck, National Institute for Health Research, and the Wellcome Trust, outside the submitted work; personal fees from the British Heart Foundation and UK Biobank, outside the submitted work; other support from Pfizer to the Nuffield Department of Population Health (prize for independent research); and a patent for a statin-related myopathy genetic test licensed to University of Oxford from Boston Heart Diagnostics (RC has waived any personal reward). CB reports grants from the Medical Research Council and British Heart Foundation, during the conduct of the study; and grants from Pfizer, Merck, Novartis, and Boehringer Ingelheim, outside the submitted work. AK reports grants from Abbott and Mylan, outside the submitted work; and personal fees from Abbott, Amgen, AstraZeneca, Mylan, and Pfizer, outside the submitted work. LB reports grants from UK Medical Research Council and the British Heart Foundation during the conduct of the study.

As to the study itself. I wrote this as a ‘rapid response’ to an article Colin Baigent wrote in the BMJ about the study. It may be published, it may not be.

‘I would like to ask Colin Baigent one question on this study – at this time.  He claims that the Lancet study was a meta-analysis of twenty-eight RCTs. The study was called. ‘Efficacy and safety of statin therapy in older people: a meta-analysis of individual participant data from 28 randomised controlled trials.’

However, in the Appendix to the Lancet paper it is made clear that five of the studies are a comparison of high dose vs. low dose statins. PROVE-IT, A to Z, TNT, IDEAL and SEARCH. They cannot be used to test the hypothesis that statins are beneficial in the over 75s vs. placebo, as they were not done to answer this question.

Also, in nine of the RCTs used in the meta-analysis there were 0% participants over the age of 75 at the start of the study. These were 4S, WOSCOPS, CARE, Post CABG, AFCAPS/TexCaps, ALERT, LIPID, ASPEN and MEGA.

Which means that five of the studies could not address the question of statins vs placebo in the over 75s, and nine of the studies had no participants over the age of 75, which leaves fourteen studies that would be relevant to the issue of prescribing statins in the over 75s.

My question is, why did you call this study ‘Efficacy and safety of statin therapy in older people: a meta-analysis of individual participant data from 28 randomised controlled trials.‘

Yes, they claimed to have done a meta-analysis of twenty-eight studies, yet they could only use data from fourteen to make their claims. The largest of which was the Heart Protection Study (HPS), carried out by, guess who, Rory Collins from the CTSU and CTT.

As for the actual data, it is the usual obfuscation, skirting as close to the direct lie as possible without crossing that line. I am just going to look at one issue. The main claim was that “statin therapy or a more intensive statin regimen produced a 21% (RR 0·79, 95% CI 0·77–0·81) proportional reduction in major vascular events per 1·0 mmol/L reduction in LDL cholesterol.”

A 21% reduction in major vascular events. That sounds terribly impressive. However, if you have read my book Doctoring Data you will know that what is most important here is not what is said, it is what is not said.

Do you see any mention of overall mortality here? No, you don’t. Which means that it did not change. Also, you may note this wording ‘reduction in major vascular events.’ What is a major vascular event? Well, it is mainly a non-fatal heart attack or a non-fatal stroke. There are other CV events, but they are much less common.

Note again, no mention of fatal CV events. If there had been a reduction here, it would have been trumpeted from the rooftops. Which means that we have no reduction in mortality and no reduction in fatal CV events. Of course, it is worth preventing non-fatal heart attacks and strokes, as these can be extremely damaging and harmful things.

However, there is something worth mentioning here that I have not really covered before. There are heart attacks and heart attacks, and strokes and strokes. A heart attack (MI) can be a crushing near-death event, leaving the heart severely weakened and liable to trigger into a fatal heart arrythmia at any time. The patient can be left a cardiac cripple.

Alternatively, a heart attack can be diagnosed by a marginal rise in cardiac enzymes with no symptoms at all, and no residual problems. Yet, both of these events, so completely different in their impact, will be listed as a non-fatal heart attack, with precisely the same weighting.

Equally, a stroke can leave the person virtually paralysed down one side, incontinent, unable to speak, eat, or move. Or, it can be a half hour strange sensation with slight facial weakness that fully resolves. Again, both these events will be listed with precisely the same weighting.

That is a problem in itself, in that these trials list events of completely different severity as being equivalent. It also leads into another problem, who is going to make the diagnosis of a mild heart attack or stroke – and on what grounds?

It will most likely be a doctor, and that doctor will have prior knowledge of whether or not the patient was on a statin – or placebo. Yes, I know, clinical trials are supposed to be double-blinded, which means that neither the participant, nor the investigator, should know who is taking the drug, or the placebo.

However, in reality, they both know full well.

I was at a meeting a while back where one of the investigators for the PCKS-9 drug Repatha was talking about the study. At one point he mentioned that a trial participant had told him that he knew he was not taking the cholesterol lowering agent. When questioned how he knew this, the participant said – because my cholesterol level is the same as it always was.

He still wanted to continue on the trial, because he thought we was doing a ‘good’ thing and helping to move medicine forward – and suchlike. I feel it may be considered churlish to point out that the only thing he was helping to move forward was the profit margins for Amgen.

The reality is that when you have a medication that has a significant effect, e.g. lowering cholesterol by 40%, this is a very difficult to thing to hide from the patient, or the doctor. They can see the figures on a computer screen in front of them. And when you are on a clinical trial, and you enter hospital, the doctors have to be told you are in a clinical trial, and what it is.

So, these double blinded studies on statins are not effectively, or even remotely, double-blinded. Which means that bias in clinical decision making is now an option. Was it a heart attack, or not? Well, they are on a statin – so probably not. Or, they are taking a placebo, so it probably is. Bias, the very thing you are trying to remove has crept straight back in the side door.

Another issue with an event is that there are many different sorts of clinical event. Death would be one – obviously. Breaking your leg another. Kidney failure would also count as one, as would a severe rash, or emergency admission to a hospital for almost any reason.

So, when a study states, as this one does ‘reduction in major vascular events.’ My mind, as it is now trained to do, thinks to itself: “ What about other events, what happened to them? Were they also reduced, did they say the same, or did they go up?”

Because if you reduce major vascular events, but other serious events go up, then you have achieved exactly and precisely nothing. This is a variation on pushing people off cliffs to stop them dying of heart attacks.

Results: ‘Pushing one hundred people prevented all trial participants from suffering a fatal heart attack. We therefore recommend pushing everyone off a cliff to reduce the incidence of heart attacks in the general population.’ A.N. Idiot et al.

Statins reduce major vascular events. [A major non-fatal vascular event could also be called as Serious Adverse Event (SAE)]. But do they reduce all serious adverse events (SEAs). If not, you are simply replacing a major vascular event with something equally nasty.

Which leads on to the next question, do we know from the statin trials if statins do reduce SAEs in total? The answer is that we do not know this, for sure, because the CTT has these data, and refuses to let anyone else see them. However, some data has not been censored by big brother. The Cochrane collaboration (before they started the sad slide to bias and corruption) looked at this issue – way back in 2003.

They got as much data as they could from the five major primary prevention statin trials at the time. Here was their conclusion on Serious Adverse Events:

‘In the two trials where serious adverse events are reported, the 1.8% absolute reduction in myocardial infarction and stroke should be reflected by a similar absolute reduction in total serious adverse events; myocardial infarction and stroke are, by definition, serious adverse events. However, this is not the case; serious adverse events are similar in the statin group, 44.2%, and the control group, 43.9%.

This is consistent with the possibility that unrecognized serious adverse events are increased by statin therapy and that the magnitude of the increase is similar to the magnitude of the reduction in cardiovascular serious adverse events in these populations. This hypothesis needs to be tested by analysis of total serious adverse event data in both past and future statin trials. Serious adverse event data is available to trial authors, drug companies and drug regulators. The other measure of overall impact, total mortality, is available in all five trials and is not reduced by statin therapy.’ ³

What does this mean in reality? Well, gathering it all together. Statins (in the over 75s) do not reduce mortality. They do not prevent fatal Mis and strokes. Whilst they reduce serious cardiac events, previously published results demonstrate they do not reduce total serious adverse events.

Which means that they are, wait for it, absolutely and completely useless.

Two plus two does equal four. Always bear that fact in mind.

1: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)31942-1/fulltext

2: https://www.heart.org/en/news/2019/01/28/medical-experts-sound-the-alarm-on-medical-misinformation

3: https://www.ti.ubc.ca/pages/letter48.htm

 

18th December 2019

As readers of this blog know I was obliterated from Wikipedia recently. Many have expressed support and told me not to get down about it. To be perfectly frank, the only time I knew I was on Wikipedia was when someone told me I was going to be removed. So it hasn’t caused great psychological trauma.

In fact my feelings about this are probably best expressed on a Roman tombstone. It has been translated in different ways, but my favourite version is the following:

I was not
I was
I am not
I care not

However, in the greater scheme of things, whilst my removal from Wiki is completely irrelevant, in another way it is hugely important. As Saladin said of Jerusalem, whilst he was battling with the Christians during the crusades. ‘What is Jerusalem? Jerusalem is nothing; Jerusalem is everything.’

My removal from Wikipedia is nothing. My removal from Wikipedia is everything. Not because it is me, but because of what it represents. Not to beat about the bush, there is a war going on out there between scientific enlightenment, and the forces of darkness.

You think that is too dramatic? Well, this is what Richard Horton – editor of the Lancet for many years – has to say about the current state of medical science.

‘The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue…science has taken a turn towards darkness.’ Richard Horton

Science has taken a turn towards darkness? Of course science cannot really turn anywhere. It is not an entity. Science is simply made up of people. The scientific method itself is simply an attempt to discover what is factually true, by removing human bias. It is, like everything humans do, imperfect. Bias is always there.

What Horton means is that the methods used to pursue science have increasingly moved from the pure Olympian ideal, a disinterested quest for truth, to something else. Distortion, manipulation and bias. In some cases downright lies. I hesitate to use the term ‘fake news’, but that is what it is. What it is becoming.

As John Ioannidis had to say in his seminal paper ‘Why most published research findings are false’

‘Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias. It is more likely for a research claim to be false than true.^’1

I think, in truth, this very much depends on the area of science you are looking at. Someone examining the food intake of the fruit bat is probably working away free from any pressure to make their findings fit with pre-existing ideas. Whilst they could be wrong, they will not been working to any agenda.

Some areas are highly contentious, where truth becomes the first casualty. For example, global warming, where you can see dreadful science being done on all sides, as people desperately try to prove their point. I watch on, in scientific despair. I have no idea what to believe, or who to believe, anymore.

Moving back to medical scientific research, which is more my area. Much of what is going on here is a complete disaster, but nutritional science is particularly awful. A complete mess. I have virtually given up reading any paper in this area as they just annoy me so much. I simply look at the authors involved, and I know what the paper is going to say. This does save time.

Ioannidis has turned his attention to nutritional science, in some detail. To quote from The American Council on Science and Health:

Dr. Ioannidis bluntly states that nutrition epidemiology is in need of “radical reform.” In a paragraph that perfectly captures the absurdity of the field, he writes:

“…eating 12 hazelnuts daily (1 oz) would prolong life by 12 years (ie,1 year per hazelnut), drinking 3 cups of coffee daily would achieve a similar gain of 12 extra years, and eating a single mandarin orange daily (80 g) would add 5 years of life. Conversely, consuming 1 egg daily would reduce life expectancy by 6 years, and eating 2 slices of bacon (30 g) daily would shorten life by a decade, an effect worse than smoking. Could these results possibly be true?”

The answer to his rhetorical question is obviously no. So, how did this garbage get published?

How did this garbage get published? How does the garbage get published? On the other hand how did a major study on replacing saturated fat with polyunsaturated fat (The Minnesota Coronary Experiment) NOT get published?

Because it found that polyunsaturated fat did lower cholesterol levels, but the more it lowered the cholesterol level, the greater the risk of death! That is in the results, and you can read that for yourself – this was the conclusion:

Available evidence from randomized controlled trials shows that replacement of saturated fat in the diet with linoleic acid effectively lowers serum cholesterol but does not support the hypothesis that this translates to a lower risk of death from coronary heart disease or all causes. Findings from the Minnesota Coronary Experiment add to growing evidence that incomplete publication has contributed to overestimation of the benefits of replacing saturated fat with vegetable oils rich in linoleic acid. ²

The results of this study were, eventually found in the garage of the son of one of the lead investigators. It was recovered and published forty years later in the British Medical Journal. Long after one of the lead investigators, Ancel Keys, had died. Yes, indeed.

I wrote the book “Doctoring Data” to try and shine some light on the methods used to distort and manipulate data. I try, as best as I can, to follow the scientific method. That includes discussion and debate, to test ones ideas in the furnace of sustained attacks.

However, if you try to do this, the forces of darkness come after you, and they come hard. Especially if ever dare to suggest that animal fats, saturated fats, are not in the least harmful. At which point you waken the vegan beast, and this beast is not the least interested in science, or the scientific method, or discussion or debate.

It has one aim, and that is to silence anyone, anywhere, who dares to question the vegan philosophy. Aided and abetted by the Seventh Day Adventist church. Below is a short list, non-exhaustive list, of those who have suffered their wrath:

Prof Tim Noakes – South Africa
Dr Maryanne Demasi – Australia
Dr Gary Fettke – Australia
Professor John Yudkin – UK
Dr Aseem Malhotra – UK
Dr Uffe Ravnskov – Sweden
Dr Andreas Eenfeldt – Sweden
Dr Zoe Harcombe – UK
Dr Robert Atkins – US
Nina Teicholz – US
Gary Taubes – US
Dr. Anna Dahlqvist – Sweden

Several of these doctors have been dragged in front of the medical authorities, usually by dieticians, who claim that patients are being damaged. So far, they have all won their cases – often after prolonged and expensive legal hearings. Luckily, the courts recognise logic when they see it.

Uffe Ravnskov has his book, the Cholesterol Myths, questioning the cholesterol hypothesis burned, live on air. All of the brave souls on this list have been accused of ‘killing thousands’ at one time or another. Maryanne Demasi lost her job with the Australian Broadcasting Company.

Now, it seems, the attacks have moved into a different area, such as a determined effort to remove everyone from Wikipedia. When the vegans find someone they don’t like, they work tirelessly to extinguish them from the record. They call them kooks and quacks – but they never ever reveal who they truly are. They exist in the shadows.

They got rid of me from Wikipedia; they are currently attacking Aseem Malhotra, Uffe Ravnskov, Jimmy Moore, and the entire THINCS network. (The International Network of Cholesterol Sceptics). There are even worse things going on, that I cannot speak about yet.

Yes, this is science today. At least it is one part of science – which is not science, and it has definitely turned to the darkness. You can be accused of being a kook and a quack by someone who hides behind anonymity and never dares to show their face. In truth, I know who it is. Someone found out for me. Yes MCE, it is you.

You want a debate, come out into the open, and reveal yourself, your motives and your arguments to the world. Then we can do science. Until then please expect me to hold you in the contempt that you deserve.

1: https://www.ncbi.nlm.nih.gov/pubmed/16060722/

2: https://www.bmj.com/content/353/bmj.i1246

 

 

19th September 2018

As many of you now know, Peter Gøtzsche was recently expelled from the Cochrane Collaboration. I was going to write a blog on it, but Maryanne Demasi has already written an excellent blog which covers most of what I was going to say. I would recommend that everyone reads it.¹

I would simply add that, when an organisation that I had a lot of time for, the organisation now known as Cochrane, which used to be the Cochrane Collaboration, loses its way, one wonders if the lamps truly are turning out across the world. Perhaps never to be turned on again.

President Dwight Eisenhower made this warning to the world in 1961:

On Jan. 17, 1961, President Dwight Eisenhower gave the nation a dire warning about what he described as a threat to democratic government. He called it the military-industrial complex, a formidable union of defense contractors and the armed forces.

Eisenhower, a retired five-star Army general, the man who led the allies on D-Day, made the remarks in his farewell speech from the White House.

As NPR’s Tom Bowman tells Morning Edition co-host Renee Montagne, Eisenhower used the speech to warn about “the immense military establishment” that had joined with “a large arms industry.”

Here’s an excerpt:

“In the councils of government, we must guard against the acquisition of unwarranted influence, whether sought or unsought, by the military-industrial complex. The potential for the disastrous rise of misplaced power exists, and will persist.” ²

Had Eisenhower been alive today, I am certain that he would have recognised another player had joined the party. The ‘pharmaceutical/medical device industry complex.’ His warning about ‘the potential for the disastrous rise of misplaced power exists, and will persist,’ is equally valid today.

In fact, it is not a ‘potential.’ It has happened.

‘The lamps are going out all over Europe, we shall not see them lit again in our life-time.’ Edward Gray.

1: https://blogs.bmj.com/bmjebmspotlight/2018/09/16/cochrane-a-sinking-ship/

2: https://www.npr.org/2011/01/17/132942244/ikes-warning-of-military-expansion-50-years-later?t=1537279215799

20th February 2018

[The high fat low carb conspiracy]

Some of you may remember I wrote a blog about Professor Tim Noakes being dragged in front of the Health Professionals Council of South Africa (HPCSA) last year to face charges of “Doing something quite bad, but we are not quite sure what – and we will keep changing the charges until we find something that sticks”.

The case centred around a tweet that Tim Noakes wrote several years ago, on a discussion forum. He was accused of providing a medical consultation – online. [The HPCSA had no guidelines on what constituted an online consultation]. Earlier in the hearing, which started way back in 2015, witnesses for the HPCSA said a consultation was required before any advice could be given or diagnosis made.

The tweets were:

The mother’s tweet read: “@ProfTimNoakes @SalCreed is LCHF eating ok for breastfeeding mums? Worried about all the dairy + cauliflower = wind for babies?? [sic]”

The mum obviously knew what LCHF was (real, nutritious food) & tweeted Noakes and his co-author of Real Meal Revolution. Noakes replied: “Baby doesn’t eat the dairy and cauliflower. Just very healthy high-fat breast milk. Key is to ween [sic] baby onto LCHF.

The primary accusation was that Professor Tim Noakes was guilty of serious professional misconduct. Really, to be struck off on the basis of one tweet, that tweet, and that’s it. The accusation was based on two questions:

Question One: does this constitute a medical consultation?

Question Two: if this is advice, is it dangerous or damaging?

Both accusations, plus a few others, were thrown out at the first hearing last April. Even though the HPCSA was acting as judge, jury, and executioner, as part of its own enquiry, set up by itself. So, they must have had a bloody weak case if the HPCSA itself couldn’t even convince itself that it was right!

You would think that would have been the end of it. But no. The HPCSA obviously feels that the HPCSA is completely incompetent, so it appealed its own decision. You can read in more detail the utter ridiculousness of what it going on here: http://foodmed.net/2018/02/noakes-hpcsa-appeal-evidence-dietitians-setup/

If this were not so Kafkaesque and strange, it would be funny. It is not funny because it is crystal clear that certain members of the HPCSA, who some would allege have significant financial conflicts of interest, are pursuing a vendetta against Professor Tim Noakes. Just as happened to the Australian Orthopaedic surgeon, Gary Fettke.

In Australia, Gary Fettke, was silenced by the Australian Health Practitioners Regulatory Authority (AHPRA) for daring to advise patients to eat fewer carbs and more fat – a High Fat Low Carb (HFLC) diet.

He had been struggling to operate on obese patients and wondered if anything could be done to help them lose weight. He found that the high fat low carb worked. His tale is both hilarious and deeply upsetting. His wife is now blogging on his behalf: http://www.nofructose.com/gary-fettke/

Following various hearings, Gary Fettke was warned not to give any more advice on diet. And, even if his views on HFLC become accepted medical practice, he will not be allowed to talk about them to any patient – ever. Which is perhaps the most stupid judgement in the history of any medical authority – and that takes some doing. A doctor unable to tell his patients about best medical practice.

Patient:            “Tell me Dr Fettke, what do you think I should eat to help me lose weight and control my diabetes?”

Dr Fettke:         “I am sorry I am not allowed to talk to you about such matters, for I am a mere orthopaedic surgeon who cannot understand such complex things. For that you must talk to a dietician.’’

Yes, really. Yes…really.

I watched MaryAnne Demasi ripped to shreds in Australia, losing her job at the Australian Broadcasting Corporation (ABC) for daring to produce and present two programmes, one supporting a high fat, low carb diet – the other criticising statins. There, are of course many others who have been attacked. Even me, although the attacks have been more ‘character assassination’ than any attempt to strike me off the medical register – so far.

You do not need to be a conspiracy theorist to be very deeply worried about the tactics used to silence anyone who dares to promote a high fat low carbohydrate diet. You don’t need to be a conspiracy theorist, because it is quite clear that there is conspiracy to silence anyone who dares stick their head over the parapet on this issue.

So, yes, I want to teach the world to sing… Sorry, got that wrong. I want to teach the world to sign a petition supporting Professor Tim Noakes and his battle in South Africa.

https://www.change.org/p/health-professions-council-of-south-africa-stop-the-harassment-of-prof-tim-noakes

I also want to do what I can to keep this issue up there, in front of as many people as possible. Otherwise Professor Tim Noakes will be shredded, on made up charges, held in virtual secrecy. After which, the industry sponsored PR machine will get to work. ‘Tim Noakes guilty of professional misconduct for promoting high fat low carb diet in children.’ ‘Panel members warn of serious harm to children from Tim Noakes advice.’

A lie, as Winston Churchill once opined, is halfway round the world, before the truth has a chance to get its boots on. Let us shine a bit of light on the lie, before the starting gun fires.

Whilst on a short break I picked up the Times Newspaper on Friday the ninth of October. There were two headlines. The main one was ‘Fizzy drinks giant pays millions to diet experts.’ On the other side of the page was ‘Revolution for FIfa after Blatter gets red card.’

The fizzy drinks company was, of course, Coca Cola. I wondered why the headline did not say ‘Coca Cola pays millions to diet experts.’ Perhaps that was just a step too far to upsetting a major advertiser. Although I note that the picture of Sepp Blatter had a large Coca -Cola sign above his head. So, somebody at the Times clearly has a sense of humour.

Now I looked at these headlines and I thought, as I find myself doing most of the time nowadays. Corruption, corruption, corruption everywhere. Sepp Blatter is almost heroic in his ability to brush aside allegations against him and his organisation. ‘I knew nothing about anything.’ Seems to be his defence. Well, if he didn’t know anything he’s incompetent, if he did, he is corrupt. I suspect both.

As for Coca Cola. They just pay ‘experts’ large sums of money, and the expected messages flow forth. According to the Times article they set up the European Hydration Institute to promote… hydration. Which sounds quite innocuous and nothing to do with Coca-Cola at all.

However, guess which drinks people should hydrate themselves with. Why…. Let me think. They get a Professor Ron Maughan to state the dehydration was an ‘unrecognised danger’ for drivers. Drivers should regularly stop and buy drinks to ensure they are properly hydrated with drinks such as… Why… let me think.

Of course, by pretending the European Hydration Institute is some sort of independent academic body, such messages are not simply seen as adverts for Coca Cola, Oasis, and suchlike. This arm’s length marketing is a very old trick now. Heart UK is a charity which is dedicated to warning of the dangers of cholesterol. Heart UK ruthlessly promotes cholesterol lowering as the most important function of the medical profession. Of course it is almost entirely funded by pharmaceutical companies who make cholesterol lowering drugs. [I would say entirely funded, but I am not absolutely sure about this].

Various experts give talks on behalf of Heart UK, paid for by Heart UK, then claim they receive no money from the pharmaceutical industry. Which is, of course, technically correct. They do not receive money from the pharmaceutical industry. Heart UK receives money from the pharmaceutical industry, they then pay the expert, and the expert need not even declare a conflict of interest. ‘How dare you say that I take money from the pharmaceutical industry, you dirty knave…. I did this work for a charity. A charity I say.’

This is also how Sir Rory Collins works. He runs the Clinical Trial Service Unit (CTSU) in Oxford. It runs trials that are almost entirely funded by the pharmaceutical industry. Nearly three hundred million pounds sterling ($500m) over the last ten years or so. He states he receives no money from the pharmaceutical industry, and therefore is not biased in any way. Once again…Industry pays CTSU, CTSU pays Sir Rory Collins = no payment from industry and no conflicts of interest. And if you believe that.

Wherever you look. Wherever I look it is the same old story. Experts are inevitably bought and paid for by one company or another. The messages that come out are universally supportive of the company’s products. If you are not sufficiently supportive the companies will go find something else to turn into an ‘expert.’

As the Times reports ‘In 2013 Spanish researchers found that scientific papers on sugary drinks that were sponsored by or had potential conflicts of interest with the food and drink industry, including Coca-Cola were five times more likely to find no link with obesity than similar papers that were independently funded. They recommend “special efforts to preclude funding by parties with vested interests at all levels.’

In truth, I don’t care that much about Fifa and the endemic corruption thereof. If people can be bribed sufficiently to hold a World Cup in Qatar, average summer temperature 50c, the world is not going to come to an end. Although a few footballers might. Obviously, it would be better if the countries with the best bid actually won, but no-one is going to die. Probably.

However, if companies such as Coca-Cola can fund research that distorts science and promotes the consumption of sugary drink, and helps to create millions upon millions of people with type II diabetes then this is very serious stuff indeed. The increase in morbidly and mortality could end up bankrupting health services around the world.

I know that all organisations and companies, if they are not properly policed, will end up travelling the road to corruption. It seems an immutable law of commerce. In a way I don’t blame the companies. They are, by their nature wolves. If I have a thousand sheep in a field and find the wolves circling, I do not say the wolves, ‘now, really, I do not want you to eat the sheep. Do you promise?’

Wolves: ‘Yes, we promise.’

Shepherd: ‘Good.’

Next day, shepherd arrives, sheep mostly eaten, wolves fat. Well, what do you expect? Wolves eat sheep. It is what they do. If you want to stop this happening, build a bloody great fence, or buy some guns, or both. Don’t rely on wolves to suddenly start acting like sheepdogs.

No, I don’t blame the companies for being companies. I blame our politicians. It is only they who can create a system of policing and punishment that will stop companies corrupting researchers, or corrupt researchers demanding money from companies. Yes, this is not a one way street. You can’t have corruption if researchers don’t take bribes.

Unfortunately politicians seem perfectly uninterested in corruption in the medical field. Is it because they themselves are being bribed. I am certain that this is part of it. In the UK large numbers of MPs are non-exec directors of private health companies, and the corporate world swirls around and within the political arena far, far, too closely. Before the last election David Cameron stated that lobbying would be next great scandal.

He says nothing of the sort now, yet lobbying and manipulating on behalf of large corporations has become worse and worse. The UK has not yet reached the situation in the US where lobbyists outnumber politicians by about a hundred to one…. Or thereabouts. And when politicians stop being politicians they immediately become lobbyists. But we heading in that direction.

So where are we? A long, long way down the longest road. The road that ends with everyone in any position of power becoming, essentially, a spokesman for large corporations, where there is no-one left who can or will do anything to stop it. Because, sadly, they are all in it together. I write that last sentence and think, oops, have I just become a conspiracy theorist. Then I think. No, I am not a conspiracy theorist, I am simply Winston Smith.