What’s wrong with the NHS? – part five

29th December 2023

The underlying forces

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

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

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

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

Medico-legal pressure to record absolutely … everything

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Yes, was the answer.

Can we row this back?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Very high LDL no impact on plaque progression

10th December 2023

A very important study – please watch

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

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

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

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

‘Transcript (ish) from video:-

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

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

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

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

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

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

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

The presentation can be seen below:

What’s wrong with the NHS? – Part 4

8th December 2023

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

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

So, clearly, they don’t.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

What is wrong with the NHS? – Part 3

27th November 2023

Relentlessly falling productivity (Part a).

Regulatory constraints.

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

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

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

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

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

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

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

Why is it happening? Are staff working less hard?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Overall, around twenty per cent more clinical staff:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

To begin.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Are they all necessary?

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

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

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

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

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

What is wrong with the NHS? Part two.

20th October 2023

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

The Quality and Outcomes Framework

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

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

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

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

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

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

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

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

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

We do, we do, we do we do.

Or maybe – we don’t.

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

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

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

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

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

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

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

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

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

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

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

A stitch in time

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

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

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

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

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

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

Here is a recent study published in Nature:

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

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

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

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

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

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

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

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

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

What is wrong with the NHS?

9th October 2023

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

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

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

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

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

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

Here from the draft guidelines:

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

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

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

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

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

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

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

As for the Oliver McGowan training itself:

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

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

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

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

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

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

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

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

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

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

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

Their main finding:

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

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

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

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

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

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

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

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

Libel Case

4th June 2023

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

It was reported in the BMJ last year:

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

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

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

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

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

Watch this space, as they say.


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

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

Broken Science Initiative

17th March 2023

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

3: https://brokenscience.org/

Returning to COVID19

31st January 2023

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

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

At one point she actually said the following:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Anyway, this graph starts in the winter of 2017 and ends about now. The vertical lines are drawn at midnight on Dec 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.

1: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9368251/

2: https://www.spectator.co.uk/article/the-censorious-war-on-lockdown-sceptics/

3: https://drmalcolmkendrick.org/2020/03/29/a-health-economic-perspective-on-covid-19/

What is corruption – and why does it matter so much?

12th January 2023

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

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

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

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

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

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

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

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

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

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

  • Norway
  • Finland
  • Sweden
  • Denmark
  • Estonia

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

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

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

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

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

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

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

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

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

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

Money

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

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

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

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

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

In addition:

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

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

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

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

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

There were other defenders, from Oxford University.

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

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

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

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

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

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

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

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

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

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

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

Authority = power = influence

Influence ↔ money.

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

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

Or, to quote the industry view on such matters:

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

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

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

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

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

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

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

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

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

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

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

These are, of course, in themselves terrible things.

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

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

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

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

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

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

Just have a look at the graph 4:

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

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

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

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

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

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

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

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

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

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

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

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

He doubts a similar breakthrough could be achieved in today’s academic culture, because of the expectations on academics to collaborate and keep churning out papers. He said: “It’s difficult to imagine how I would ever have enough peace and quiet in the present sort of climate to do what I did in 1964.5

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

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

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

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

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

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

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

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

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

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

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

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

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

Drug regulation – How does it work?

31st December 2022

Before laying into the drug regulators, and their inexorable move towards the dark side, I thought I should try to explain a bit more about who decides what drugs should be used, and for what conditions.

Yes, I know, for most people this appears simple. The Federal Drugs Administration (FDA), in the US, or the European Medicines Agency (EMA), for the European Union, approve drugs for use in human beings, and that’s pretty much that.

Other countries have their own drug evaluation agencies, but l have no intention of looking at them in any detail. Also, if the FDA and EMEA approve drugs, then they are pretty much waved through elsewhere. A statement that will no doubt be assailed by various parties but I stand by it.

In short, if these two big agencies say a drug is safe – and effective enough – it is given their stamp of approval. It is then allowed to be prescribed … pretty much worldwide. Therefore, yes, the FDA/EMA represent the first hurdle that needs to be cleared, or your drug is going nowhere.

However, this once formidable hurdle has been hammered down into an almost unnoticeable speed bump, sitting about one inch above the ground. To quote from Forbes magazine – as far back as 2015 ‘The FDA Is Basically Approving Everything. Here’s The Data To Prove It.’ 1

‘In 2008, companies asked for 134 approvals and got 75 of them, a 56% approval rate. That rate hovered steady in 2009 and 2010, and then rose to about 70% in 2011, 2012, and 2013. Last year it jumped to 77%, with 97 out of 126 requests for approval coming back positive. This year’s approval rate? It was 88%…

in reality, the FDA approval rate is more like 96%. Eliminating BioMedTracker’s counting of multiple uses for the same drug means FDA approved 23 drugs and rejected 1, Merck ’s anesthesia antidote, Bridion. Again, that means 19 of 20 new drug applications were approved.’

Drug companies have long since worked out how to neutralise the FDA and EMA. Which means that the big effort, nowadays, is made in working with other, increasingly important ‘agencies’, to achieve three main things:

  • Market expansion
  • New indications for use
  • Co-opting ‘your’ drugs into the guidelines

I think of FDA approval as establishing the initial bridgehead in a seaborne invasion. Once you have landed, you can then spread out to take over the rest of the country. This has become a massive and resource intensive exercise and involves many other different ‘agencies’ that need to be brought to heel.

In the UK, for example, a clear second barrier to drug use is (or more accurately ‘was’) the National Institute for Clinical and Health Excellence (NICE). This ‘agency’ was set up to decide if a drug, or other medical intervention, provided good value for money.

If not, NICE said no, and the drug would not be approved. Doctors could still prescribe such drugs, but it was much frowned upon, and could result in various sanctions.

When it started, in 1999, NICE decreed that no healthcare intervention should cost more than thirty thousand pounds for each year of perfect quality life that it provided (approx. $40K). One year of perfect health is known as one quality adjusted life year (1 QALY). Calculating QALYs is fraught with assumptions and models, and suchlike, which I am not going into here.

Where did this thirty thousand figure come from? The truth is that was plucked from thin air. Strangely, this figure has never increased, in well over twenty years. It is inflation proof. It is also endlessly flexible. Think of it as the pot of gold at the end of the rainbow. You know it is there, but it can never truly be seen, or pinned down. This allows for endless fudging to take place, depending on how the media and politicians react to their decisions.

The first ever judgement of NICE was to turn down the anti-flu drug Relenza. I think it was just to show how ruthless and anti-industry they were going to be. A flag rammed into the ground. ‘We own this territory.’ This caused the CEO of Glaxo Smith Kline (GSK) to hurl his toys out of the pram. Various drug companies sent a letter to Tony Blair, the Prime Minster at the time:

“We warned that NICE’s activities could have worldwide repercussions for sales of the medicines concerned and that it could send out deeply damaging signals about the future rewards for innovation. We received repeated assurances from Ministers and from Sir Michael Rawlins (head of the NICE) that our concerns were well understood and that NICE would not operate as a fourth hurdle for new medicines. The landmark ruling on Relenza makes it crystal clear that our worst fears were fully justified,” it said.

The letter went on: “the emergence of NICE as a new obstacle to market entry serves to wipe out, at a stroke, a key element of the UK’s competitive advantage in the global pharmaceutical industry. It is self-evident that any savings to the NHS resulting from restricting access to new medicines will be insignificant when set alongside the potential loss of the UK’s current international standing in the pharmaceutical industry.”

“Much damage has already been done by NICE’s recommendation….the government must act swiftly now to limit and repair the damage by making clear that its response to NICE will take full account of the wider implications of its activities and that new medicines approved by the MCA will continue to have immediate access to the NHS,” said Dr McKillop.2

I think GSK threatened to pull out of the UK altogether. In the medical world we call the ‘I am going to scweam and scweam and scweam until I am sick, sick, sick.’ business strategy.

However, it did not take long before the industry ceased their pitiful screaming and realised the NICE could be one of their most valuable assets. How so? Primarily because other countries do not really have a NICE equivalent, and many of them look to the judgements of NICE for guidance. If NICE say yes, then they will almost always say yes as well. Bingo.

Ergo, if you manage to get NICE to say that your drug it not only safe and effective, but also cost-effective. This opens the doors worldwide. The market is yours. And so, inevitably, NICE has gone the way of the FDA. They now approve, pretty much everything. Increasingly, they don’t even bother to let anyone know how they worked out their figures.

For example, we can take a look at the drug Inclisiran. This is a cholesterol lowering injectable drug, known as a PCSK9-Inhibitor. A number of different PCSK-9 inhibitors have reached the market recently. They all lower cholesterol (LDL) more than statins – hooray (or perhaps not). They are all, also, mind-bogglingly more expensive.

A year’s supply of a statin now costs about thirty pounds (forty dollars) per year. At least it does in the UK. On the other hand, a one-year supply of a PCSK-9 inhibitor costs around five thousand. Some cost a bit more, some less. However, they are all at least one hundred times more expensive than statins, more like two hundred.

I once idly calculated that if everyone taking a statin were to move over to a PCSK9- Inhibitor instead, it would cost the NHS around sixty billion pounds a year. Which would mean cancelling almost all other activities. Hip replacements … you must be joking, no money left for that nonsense. Cholesterol lowering is what the NHS now does. And nothing else!

At this point you might be asking yourself. How could a drug with very few additional ‘benefits’ to a statin possibly manage to get approved by NICE? How did anyone manage to work this one out? You may be glad to know that I am not going to go through all the complicated trial results, calculations and suchlike here.

But you can, if you wish, read it all for yourself in the ‘evidence’ section of the NICE report on Inclisiran. All two hundred and forty-three pages of it. And good luck with that.3  

Over the years these NICE reports have become utterly bonkers. They are now so long, so jargon filled, with statistics filling the air. They are also so very, very, very, boring. Some may say that this is a strategy used to stop any objections to their decisions. Primarily, because no-one could possibly be bothered reading the damned thing. Bullshit baffles brains.

Little do they know that I occasionally rouse myself to look at NICE reviews in detail. Even though some parts are beyond me. Here is one very brief example of jargon-filled obfuscation taken from page sixty-five of the Inclisiran report:

‘The time-adjusted percentage change in LDL-C from baseline after Day 90 and up to Day 540 was calculated from the MMRM. Linear combinations of the estimated means after Day 90 and up to Day 540 were used to compare treatment effects.

Treatment effects from these 100 MMRM analyses were then combined using Rubin’s Method (100) via the SAS PROC MIANALYZE procedure. The difference in the least squares means between treatment groups and corresponding two-sided 95% CI was provided for hypothesis testing.’

  • The MMRM analyses?
  • Rubin’s method?
  • The SAS PROC MIANALYZE procedure?

Search me guv.

To be honest I tend to skim these parts. This is on the basis that I have better things to do with my life than find out what the SAS PROC MIANALYZE procedure might be. Instead, I spend my time searching for the key facts that have been hidden away. The secret to the magic trick. The ‘Prestige.’

As with all magic tricks:

“The first part is called “The Pledge”. The magician shows you something ordinary: a deck of cards, a bird or a man. He shows you this object. Perhaps he asks you to inspect it to see if it is indeed real, unaltered, normal. But of course … it probably isn’t.”

“The second act is called “The Turn”. The magician takes the ordinary something and makes it do something extraordinary. Now you’re looking for the secret … but you won’t find it, because of course you’re not really looking. You don’t really want to know how it, say, disappeared. You want to be fooled.”

“But you wouldn’t clap yet. Because making something disappear isn’t enough; you have to bring it back. That’s why every magic trick has a third act, the hardest part, the part we call The Prestige.” 4

Where was the ‘Prestige’ with Inclisiran? I knew it was hidden somewhere deep within those two hundred and forty-three pages. My attention designed to be cunningly diverted by such things as the SAS PROC MIANALYZE procedure. Say what? My first clue as to where the Prestige lies can be found is on page one hundred and six (see below).

Just look at those thick black lines. Yes, here is a report by a tax-payer funded Government agency. But we are not allowed to see critical data. Such as, how many participants in the trial suffered an adverse event. Nor how many discontinued the drug and – perhaps most critically – how many died. Really, they are keeping all this a secret? Yes, indeed, they are. Here is another page I thought you might enjoy. It is page 112. It is a belter. All the information you need in one critical table

Oh no, it’s all been redacted – again. After this point there is page after page, after page, of black text and thick black lines. What does it actually say beneath the censored information?

We’re in the money

Come on, my honey

Let’s spend it, lend it,

Send it rolling around!

Moving on, the single most important thing for us to know, from a NICE report, is the following?

Is Inclisiran cost-effective? Or, to put it another way, can it provide more than 1QALY for each thirty thousand pounds it costs? In addition, can it really be that much more effective than statins. [In my opinion, nothing is more effective than statins. So, use nothing].

This, then, is the central NICE question. Is Inclisiran cost-effective, or not. I cannot answer this question, and nor can you – or anyone else outside NICE. Why not, you may ask. Well, to answer this question I present you with, but one small section, that looks at the cost-effectiveness of Inclisiran.

In this case cost-effectiveness on the treatment of Atherosclerotic Cardiovascular disease (ASCVD).

As you can see… you can’t see anything. You are not allowed to. This table can be found on page 211 by the way. Quite astonishingly, all the information on costs has been redacted. This table is followed by many other with all the figures redacted. How as this happened? Because Novartis will not allow NICE to show it to you.

What is the point of doing all this work, and publishing this enormous document, if all the critical information is to be kept secret? Kept secret from the very people who pay for all the damned work. NICE is taxpayer funded, its calculations should be transparent, and its decisions should be transparent. But they are not.

The simple fact is that the pharmaceutical industry has learned how to control NICE. It has become, like the FDA and the EMA, a ‘captured’ agency. On the outside it pretends to be a fully independent scourge of the pharmaceutical agency. In reality it does exactly what it is told – by the pharmaceutical industry.

In this case, the crowd goes wild, as the magician demonstrates his Inclisiran trick.

‘Ladies and gentlemen, here is a PCSK-9 inhibitor called Inclisiran. Look at it closely. Yes, examine it any way you like (note to self, make sure they don’t actually look at anything after page 100). It costs…. What does it cost Madam. Why cost is not the issue. What matters is whether or not it is cost-effective. Am I right, madam? My, your dress is so beautiful, and your hair. If I may say magnificent.’

Woman nods and smiles.

‘Yes, you may be thinking … how can this drug possibly be cost-effective?’ Well, let me place this drug into the sealed box that we call NICE evaluation. Yes madam, a most impressive box indeed. Stamped with approval by, well, everyone. Yes, madam, everyone.’

Magician places Inclisiran into black box.

‘Now, we just need some money…. I shall stuff two million pounds into the box …

Magician stuffs the box with money, then shakes it.

‘Hey presto.’ He opens the box. ‘Yes, as you can see Inclisiran is, indeed, cost-effective. Yes sir, it is indeed, magic … what’s that, you would like to see into the box yourself. Sorry, sir, we have to keep some of our secrets to ourself …. Yes, officer, if you could just take that gentleman out and arrest him for some reason or another…’

Nowadays, the tentacles of the pharmaceutical (and medical devices industry) wrap around far more agencies than just the FDA and EMA. And is not just NICE. It is the medical societies, the opinion leaders, the charities and – let us not forget – the politicians. All are caught up its deadly embrace. No-one escapes. If they do, they immediately become a conspiracy theorist.

In the next episode I shall turn my attention to the Universities, and those who work in them. Here lies, perhaps, the greatest source of power. A place where money can be converted into both academic and medical authority. Increasingly backed up by the force of law.

1: https://www.forbes.com/sites/matthewherper/2015/08/20/the-fda-is-basically-approving-everything-heres-the-data-to-prove-it/?sh=4dfb8edb5e0a

2: https://www.thepharmaletter.com/article/uk-s-nice-turns-nasty-rejecting-glaxo-wellcome-s-anti-flu-drug-relenza

3: https://www.nice.org.uk/guidance/ta733/evidence/committee-papers-pdf-9258232573 4: https://observer.com/2020/09/the-prestige-christopher-nolan-magic-trick/

Cleaning out the Augean Stables – Part II

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

Cleaning the Augean stables (Part I)

24th November 2022

Peer-review: Time to get rid of it

‘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.

Underling:                ‘Aaaarrrgggh….’ Chomp, thrashing, blood.

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 reviewers and 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.

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

2: https://www.nature.com/articles/news.2010.132

3: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3005733/

4: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3005733/

5: https://www.politico.eu/article/lancet-review-process-following-covid-19-saga-coronavirus/

6: https://www.the-scientist.com/features/the-surgisphere-scandal-what-went-wrong–67955

We Love Our Heart

6th November 2022

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.

Please follow this link, (or click on the image or follow the link below) and help with the revolution.
(Here’s the link https://www.weloveourheart.com/register?affiliate_id=3687882 )

How the world now works – or doesn’t

30th October 2022

[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.

1: https://www.theguardian.com/society/2015/jun/24/doubt-lingers-over-jeremy-hunts-pledge-5000-new-gps

2: https://www.gov.uk/government/news/record-numbers-of-staff-working-in-the-nhs

3: ‘https://www.nmc.org.uk/globalassets/sitedocuments/registration/covid-19-temporary-emergency-registration-policy.pdf

4: https://commonslibrary.parliament.uk/expiry-of-the-coronavirus-acts-temporary-provisions/

5: https://www.gmc-uk.org/registration-and-licensing/guide-for-doctors-granted-temporary-registration

6: https://www.nursingtimes.net/news/workforce/record-number-of-nurses-leaving-the-nhs-in-england-30-09-2022/

7: https://www.bma.org.uk/advice-and-support/nhs-delivery-and-workforce/pressures/pressures-in-general-practice-data-analysis#:~:text=%2D-,Number%20of%20NHS%20GPs%20by,FTE)%20%2D%20fully%20qualified%20GPs%20only&text=Over%20the%20last%20year%2C%20the,individual%20GPs%20since%20September%202021.

8: https://twitter.com/TheSmartGP/status/1575832771821727746

COVID19 vaccination

25th October 2022

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.

Saturated fat

21st September 2022

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

1: https://academic.oup.com/eurjpc/advance-article-abstract/doi/10.1093/eurjpc/zwac194/6691821?redirectedFrom=fulltext&login=false

Postscript

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).

1: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5527850/
2: https://clinicalnutritionespen.com/article/S2405-4577(22)00293-5/fulltext

COVID19 – so many questions, so few real answers

14th September 2022

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.

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

2: https://www.science.org/content/article/more-people-are-getting-covid-19-twice-suggesting-immunity-wanes-quickly-some

3: https://www.euromomo.eu/graphs-and-maps

4: https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/lifeexpectancies/bulletins/nationallifetablesunitedkingdom/2018to2020#:~:text=estimates%20for%20Wales.-,Life%20expectancy%20at%20birth%20in%202018%20to%202020%20was%20estimated,for%20females%20in%20Northern%20Ireland.

A new paper by me – please share widely

26th August 2022

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.

Anyway, here it is. https://journals.lww.com/co-endocrinology/Fulltext/9900/Assessing_cardiovascular_disease__looking_beyond.21.aspx

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.

Thank you.

THE REASON WHY

24th August 2022

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.’