Category Archives: Conflicts of Interest

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 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.



3: ‘






The crushing power of the pharmaceutical industry – a sorry tale

18th July 2022

Here is a sorry tale about the power of the pharmaceutical industry to crush all dissent … dead. The key player is Dr. Aseem Malhotra, who some of you may know. He is a consultant cardiologist. Very bright, sparky, willing to take on the establishment when required. I get on well with him, we communicate on many different issues. He has his detractors – I am not one of them.

First, some background, to put this tale into some kind of context. It is part of an e-mail that I was sent, by Aseem. I I have modified it slightly. Basically, I changed it from first person and got rid of some typos. I have also checked with other independent witnesses, to ensure the accuracy of events:

‘Dr Aseem Malhotra was invited to deliver a keynote lecture/speech at the International Medical Graduates dinner by its organiser, Consultant Psychiatrist and Chair of the British Association of Physicians of Indian Origin (BAPIO) Dr JS Bamrah CBE. The event took place on Monday 27th June as a fringe event of the British Medical Association (BMA) Annual Representative Meeting (ARM).

Other chief guests included the Chair of the BMA (Dr Chaand Nagpaul) and the President of the BMA (Professor Nina Modi). The title of his talk was “Advocating for REAL evidence-based medicine”.

The talk was well received with excellent personal feedback including the Chair of BAPIO, Dr JS Bamrah. The event also commemorated Aseem’s late father Dr Kailash Chand Malhotra who died suddenly last year. He was honorary vice president of the BMA and on the BMA council.

The organiser of BMA education events Beryl De Souza also personally told Aseem it was a brilliant talk, and the next day sent him a text message asking him to present the same talk as an educational webinar to BMA members.

Aseem had also given a talk to over one hundred BMA members earlier in the year about heart disease, statins and cholesterol with excellent feedback. The Chairman of the British Egyptian Medical Association who was very complimentary about the talk also met Aseem the following day and asked if he would give the same talk to his members.’

It all sounded rather splendid, and mainstream, and suchlike.

But, gentle reader, beware. For there is a malignant ghost hovering over this feast. The ghost of ‘anti-vaxxer present’. Now it doesn’t take much to be accused of being an anti-vaxxer. The phrase ‘I have some concerns about mRNA vaccines’ is usually enough to be mercilessly attacked by the dementors, controlled by Facebook, Twitter and suchlike.

In this case, during his talk, Aseem presented data from a study called ‘Serious Adverse Events of Special Interest Following mRNA Vaccination in Randomized Trials.’

It is a pre-print paper, at this point, and has not yet been peer-reviewed. It is due to be published in the Elsevier journal SSRN. You can see the full paper here 1.

The authors, from such places as Stanford, UCLA and Maryland, are of high academic standing. What they did was to look at serious adverse events associated with the Pfizer and Moderna vaccines. The Discussion section of the paper states the following:

‘The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes such as hospitalization or death.’

The ‘abstract’ further states, in the results section:

Pfizer and Moderna mRNA COVID-19 vaccines were associated with an increased risk of serious adverse events of special interest, with an absolute risk increase of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95% CI -0.4 to 20.6 and -3.6 to 33.8) respectively.

Combined, the mRNA vaccines were associated with an absolute risk increase of serious adverse events of special interest of 12.5 per 10,000 (95% CI 2.1 to 22.9). The excess risk of serious adverse events of special interest surpassed the risk reduction for COVID-19 hospitalization relative to the placebo group in both Pfizer and Moderna trials (2.3 and 6.4 per 10,000 participants, respectively).’

Now, in English. According to this paper, the risk of a serious adverse event (caused by the vaccine) was greater than the reduction in hospitalisation from COVID-19 (prevented by the vaccine). Therefore, on this metric, the vaccine(s) may be doing more harm than good. [Please don’t hit me, I said ‘may’.]

Thus, Aseem committed the greatest sin imaginable today. He dared to mention a scientific study that asked questions about mRNA vaccines. And, of course, oops, I have now mentioned it too. Which clearly makes me an anti-vaxxer. Yes, quoting scientific papers is now, virtually, a crime. So, I have to strongly advise you … don’t look at the paper. Else you will become contaminated with impure thoughts and may have to be stomped on.

Oh, what a world we now live in.

Anyway. Back to Aseem’s story. Here he was, basking in glory. To top it all, he was then presented with an award. To quote … with some slight edits:

‘The next day Dr JS Bamrah informed Aseem that he was going to receive an award, to be presented by the BMA Chair, Dr Nagpaul. The award was “Champion of Preventative Medicine”. He had spoken to Dr Nagpaul on the phone who agreed.

The award was given in a break at the BMA conference. Dr Nagpaul was asked where he wants the photo to be taken of him presenting Aseem with the award. He suggested the main podium at the BMA conference hall, but the picture quality is poor, so they go elsewhere, and Dr Nagpaul was more than happy for Aseem to receive the award in front of a board in the main lobby with the BMA logo in the background. This was NOT Aseem’s suggestion.

Later that afternoon (Tuesday 28th) Aseem received the photo via text and put a tweet out (see below) in the evening with the three photos of Aseem receiving the award including with a larger group of people including the BMA president which read:

“Truly honoured to receive the “Champion of Preventive Medicine award from the Chair of the BMA @Cnagpaul. In my talk I said the science alone isn’t enough; opposition from vested interests needs to be overcome to save the #NHS. It’s time for REAL evidence-based medicine (fist bump emoji).’

But the all-seeing eye of Sauron had been ‘observing’ this unfortunate series of events. Grima Wormtongue was dispatched to whisper in the ears of those in power. ‘Yes, my precious (to mix my characters, stories, and metaphors, horribly), nasty hobbitses won’t be seen to criticise vaccines will they.’

Behind the scenes … all hell broke loose. Someone had dared to mention a study mildly critical of vaccines, and the BMA chairman GAVE HIM AN AWARD. Off with his head. ‘Whose head, please?’

‘Everyone involved in this treachery.

‘Yes boss, sure boss, right away boss….’

The tale continues:

‘The next morning, Aseem noticed a missed call and message from Dr Bamrah. “Please call Aseem. Need your tweet modified. Delete the bit about BMA council. Just say Chaand Nagpaul. Happy to explain.”

Aseem did as requested and sent another tweet specifically clarifying that it was an IMG forum award and was given to me by Chaand Nagpaul, without mentioning the BMA at all. Aseem also messaged Dr Bamrah in reference to Chaand which he also shared with him “He needs to stand his ground and not capitulate. We’ve compromised by deleting the tweet. My dad would say always stand up to bullies and cowards – that’s what he taught me.”

Chaand (CN) replies to me “Aseem the issue is who the award originated from. They’re questioning my governance – it was not an award “from me”. I know it’s semantics but real uproar”

AM: “Ok. I will delete the tweet altogether”

CN: “Much wider than this individual – within BMA too sadly – everything attributed to me has to be cleared with BMA comms while BMA chair”

AM: “Tweet deleted”

CN: “I’m going to get some sleep! It’s been incessant”

BMA releases a statement from the Chair that is read out at the conference essentially stating that the BMA does not endorse the views of Dr Aseem Malhotra and that Chaand had not actually given me the award but had “handed it over” due to politeness.

Why such a storm? Why the behind-the-scenes desperate machinations to ensure that the BMA could not, and would not be associated in any way with Aseem? Why the personal humiliations and climbdowns? Why the control over Chaand Nagpaul – who was stepping down as BMA chairman anyway? The incessant tweeting and criticism.

Was it because Aseem has always been critical of vaccines? I refer you to the fact that in early 2021 Aseem was asked to help promote the COVID-19 vaccine to the, so called, BAME (Black Asian Minority Ethnic) community. Yes, he promoted the vaccine to a particular vaccine hesitant community 2.

However, he has also, like me, been alert to the possibility of potential harm that the vaccines may cause. He is also, like me, well aware of the way that data from clinical studies can be, and is, manipulated and biased.

We both cast a highly sceptical eye over any ‘evidence’ that emerges from commercial organisations. Neither of us happily chants ‘two vaccines good, four vaccines better.’ We are both in the ‘but that man is wearing no clothes’ section of the audience. A rather smaller section, it must be said. Usually containing only two people. Him, and me.

Anyway, I thought it would be interesting to find out who, exactly, started the ‘bring me the head of Aseem Malhotra’ movement within the BMA. Could it be, I wondered, that they had a commercial conflict of interest? By which I mean, had they worked with a pharmaceutical company that made mRNA COVID19 vaccines.

Well, I have spoken to people within the BMA, at a high level, to find out exactly what went on. They confirm the details of Aseem’s story. But wish to remain nameless. It seems that a certain individual, who led the attack on Aseem, has close connections with Moderna. Surprise, surprise. As you can tell, I am treading on potentially libellous ground here, so I am not naming names. I am currently involved in a monstrously long, and complex libel suit, and I don’t want another one at present, thank you very much.

This all comes hot on the heels of an article in the British Medical Journal by Maryanne Demasi. A medical journalist whose career was destroyed when she produced and presented programmes in Australia that were critical of the cholesterol hypothesis and the, potential, over-prescribing of statins. They even tried to get her PhD removed, to further destroy her reputation.

The BMJ article was called ‘From FDA to MHRA: are drug regulators for hire?’

‘Patients and doctors expect drug regulators to provide an unbiased, rigorous assessment of investigational medicines before they hit the market. But do they have sufficient independence from the companies they are meant to regulate?’3

The short answer is no. Drug regulators have been bought and paid for by the companies that they are supposed to regulate. But the commercial influence spreads far wider than the regulators. Key opinion leaders (KOLs) who carry out the big clinical trials, who speak at conferences, and who appear at the top of influential medical organisations and write the guidelines – are often bought and paid for too.

There is virtually no area of the medical world that has not been lobbied, infiltrated and – in many cases – paid for and controlled by the pharmaceutical industry. We have a major crisis on our hands, that no-one is doing anything about.

Aseem’s tale is just one more example of the fact that anyone who dares to stand up to the relentless marketing of more and more drugs, and vaccines, will be attacked and crushed. In this case, under the banner of the British Medical Association. An organisation that I am increasingly unproud to be a member of. If the BMA can no longer support freedom of speech, then no-one can. The future looks bleak.

To quote George Orwell. ‘If you want a picture of the future, imagine a boot stamping on a human face, forever.’




COVID – What have we learned?

25th August 2020

We have learned that people who are asymptomatic can, cannot, can, cannot, can, cannot, can… spread the virus.

That the accuracy of PCR antigen testing is brilliant, useless, brilliant, useless, brilliant, useless.

That false positive tests are impossible, common, impossible, common, impossible, common.

That facemasks are useless, necessary, useless, necessary, useless… absolutely necessary.

We also know that some people are, are not, are, are not are, naturally immune. In addition, we know that having had COVID means that you can, cannot, can, cannot, can cannot – maybe you can, frankly who knows, get it again. I think Kurt Vonnegut Junior put it best:

“We do, doodley do, doodley do, doodely do,
What we must, muddily must, muddily must, muddily must;
Muddily do, muddily do, muddily do, muddily do,
Until we bust, bodily bust, bodily bust, bodily bust.”

I like to think I have some expertise in reading medical research papers, then trying to work out what they really mean, rather than what they say they mean. I even gritted my teeth and wrote the book “Doctoring Data” in order to help people understand the endless games and manipulations that are played with research studies.

I analysed the power of money to distort research findings, in ways such that black can be magically turned into white.

Of course, distortion is not just driven by money. This is only one of the factors that lays its heavy hand upon research. There are many others. The immense power of an idea to set thoughts in concrete, previous public statements made and fearing loss of authority if you change your mind. Status, power, political games, etc.

Just to look at an example of actions not (obviously) driven by money. On the back of COVID, Bill Gates seems determined to be remembered as the man who vaccinated the world. It will be his enduring legacy. He probably knows that his Microsoft empire will simply be a sub-paragraph in an MBA hypothesis in a hundred years. On the other hand, worldwide vaccination will secure him a place in history.

Although I understand many of the forces at work to distort research, and how the manipulates are carried out, when it comes to COVID I have almost given up. Almost everyone seems to have an agenda, twisting and turning meaning this way and that.

In many cases, the end result seems to be a determined effort to inflate the mortality figures, or paint COVID as the evillest virus ever. I suspect the vaccine manufacturers have a major role to play in this.

Just to give one reasonably well-known example of this. In England, if you ever had a positive test for COVID, and then died, you were added to the COVID death statistics. Whatever killed you, however long after you had a positive test you died of COVID.

This has recently been changed. Primarily because it was so patently ridiculous that even Matt Hancock (UK health secretary) was no longer able to confirm that this was absolutely the correct thing to do. Although it seems he had no idea it was happening in the first place.

Despite this change, we still have the situation in the UK, where you can never, officially recover from COVID – which is equally mad. Once you’ve got it, you’ve got it. I suspect this will be quietly changed at some point – maybe it has been, and I didn’t notice.

On the other hand, other very strange things took place, in the opposite direction. Right at the start of the pandemic, the UK Govt changed COVID to an infection no longer considered of high consequence

As of 19 March 2020, COVID-19 is no longer considered to be a high consequence infectious disease (HCID) in the UK.1

Yes, the 19th of March. The UK went into lockdown on the 16th of March [Error, this should be the 23rd march], and three days later COVID was no longer a high consequence disease. The only disease in history which has required lockdown, including the obliteration of many basic human rights, and the trashing of the entire economy. Yet it is not a disease of high consequence?

This happened virtually unremarked. Very quietly, you could almost say sneakily. What on earth went on here? My guess is this was done to stop healthcare workers suing the NHS if they contracted COVID at work – as almost no medical staff had adequate PPE. There may be other reasons, but I struggle to think what they may be.

Wherever you looked there was confusion, and statistical manipulation, and then we moved onto the hydroxychloroquine saga. At the very start of the pandemic I wrote a blog suggesting hydroxychloroquine could be helpful. This was based on earlier research demonstrating this drug could hamper viral entry into cells and, once within the cell, could impede viral entry into the nucleus. I even tried to get my trust to stockpile some of the drug – no chance there. Hydroxy-what?

Little did I know the massive storm that would erupt around this drug. A drug that has been around for decades. It is available over the counter in many countries and is, I think, the most widely used drug in India. It is primarily an anti-malarial drug – as it helps to prevent entry of the malaria parasite into cells and can hamper it breaking down haemoglobin, thus destroying red blood cells.

It is also used as an anti-inflammatory in diseases such as rheumatoid arthritis and systemic lupus erythematosus (SLE), where it is extraordinarily safe (in the correct doses). It has been looked at as a possible anti-viral for many years. Earlier this year, I was reading various papers about it. Such as this one ‘Effects of chloroquine on viral infections: an old drug against today’s diseases.’

Chloroquine is a 9-aminoquinoline known since 1934. Apart from its well-known antimalarial effects, the drug has interesting biochemical properties that might be applied against some viral infections. Chloroquine exerts direct antiviral effects, inhibiting pH-dependent steps of the replication of several viruses including members of the flaviviruses, retroviruses, and coronaviruses. Its best-studied effects are those against HIV replication, which are being tested in clinical trials. Moreover, chloroquine has immunomodulatory effects, suppressing the production/release of tumour necrosis factor α and interleukin 6, which mediate the inflammatory complications of several viral diseases’.2

[Chloroquine and hydroxychloroquine are essentially the same drug, when it comes to efficacy/activity, but hydroxychloroquine has less side-effects. ‘Hydroxy’ means an OH group has been added to the basic compound]

I have to say I didn’t bother to read anything from 2020. It was clear that commercial interests were already heavily contaminating this area.

Which meant that, in order to get a handle on untainted data, I went back to calmer research papers from another era. Anyway, having read around the area, it seemed that hydroxychloroquine might do some good. It was certainly pretty safe, and we had nothing else at the time. Thus, I recommended that it might be used.

Then, the distorting engine was switched to full power. Driven by two main fuel types. Type one was money. Companies with anti-viral agents, such as remdesivir, did not want a ‘cheap as chips’ drug being used. No sirree, they wanted massively expensive (and almost entirely useless) anti-virals to be used instead.

This resulted in a study published in the Lancet, no less, slamming hydroxychloroquine through the floor. It turns out the study was almost entirely fabricated, by researchers strongly associated with various companies who, surprise, surprise, make anti-virals.

The other fuel type was the hybrid money/vaccine. If hydroxychloroquine (plus zinc and azithromycin) works, then there was great concern this would lower uptake of any vaccine that was developed. In addition, it would not be possible to impose emergency vaccine laws, which would make the manufacture of any vaccine far quicker and easier.

Such laws, in the US, are known as Emergency Use Authorisation (EUA). If enacted, these laws mean that a vaccine does not have to be tested for safety and efficacy before use. Just whack it out there, untested. Also, there is no possibility of suing a vaccine manufacturer if it turns out the vaccine caused serious problems.

In the US, UK, and several other countries, complete legal protection against vaccine damage is already enshrined in the law, so nothing changes here.

However, there is still a requirement to carry out at least some research on efficacy and safety. The EUA would remove this barrier. Just get it out there, no questions asked, none possible.

Depending on your view of the ethical standards of those companies manufacturing such vaccines, you would either welcome this move, or feel deeply disturbed. I would be in the latter camp. No way I am taking an active medication that has not been tested for either safety or efficacy.

Whatever camp you are in, there are vast fortunes to be made from developing the first vaccine for COVID-19. If all barriers to immediate uptake are removed, we have a goldrush on our hands. No need to prove your vaccine works, no need to demonstrate it is safe, no chance of being sued. Billions of dollars to be made. What could possibly go wrong?

Which takes us back to that pesky drug, hydroxychloroquine. Does it work, does it not? It seems we will never be allowed to know. Recently the Food and Drug Administration in the US, removed authorisation for its use. Even in a hospital, such as he Henry Ford in Detroit, that appeared to be getting impressive results:

‘”The U.S. Food and Drug Administration informed us that it would not grant our request for an emergency use authorization for hydroxychloroquine for a segment of COVID-19 patients meeting very specific criteria,” said Dr. Adnan Munkarah, Henry Ford’s executive vice president and chief clinical officer, in a statement’ 3

All other trials around the world have also being stopped by the National Institutes of Health, the World Health Orhanisation and the UK health authorities.

This, remember, is a drug that has been taken by, literally, billions of people. It is considered safe enough to buy over the counter, yet now it is so dangerous that it cannot even be used for research purposes. Of course, you can still take it if you have rheumatoid arthritis, SLE, malaria – or suchlike – where it remains perfectly safe and is also known to reduce inflammation (a major problem with COVID).

At a stroke discussion, or research, has become virtually impossible, as noted by the Henry Ford hospital in Detroit.

‘Last week, Henry Ford issued an open letter about its study, saying, “the political climate that has persisted has made any objective discussion about this drug impossible.”

The health system said in the letter that it will no longer comment outside the medical community on the use of hydroxychloroquine to treat novel coronavirus.’

So, what have we learned? We have learned that medical science is not a pure thing – not in the slightest. We have also learned that the world of research has not come together to conquer COVID, it has split apart.

Those wanting to make money, have distorted and damaged research for their own ends. Those who want to vaccinate the world, forever, have seen a door open to the promised land. Those who wanted lockdown, are inflating the numbers of those killed. Democrats in the US are using COVID as a stick to beat Donald Trump. It is all a bloody horrible mess.

It is said that the first casualty of war is the truth. Never has this been more certain that with COVID. In this case, first we killed the truth, then we killed science, then we beat inconvenient facts to death with a club. It is all extraordinarily depressing.




Distorting science in the COVID pandemic

5th July 2020

This blog has been published in

I’ve lost all trust in medical research – the financial muscle of Big Pharma has been busy distorting science during the pandemic

Evidence that a cheap, over-the-counter anti-malarial drug costing £7 combats COVID-19 gets trashed. Why? Because the pharmaceutical giants want to sell you a treatment costing nearly £2,000. It’s criminal.

A few years ago, I wrote a book called Doctoring Data. This was an attempt to help people understand the background to the tidal wave of medical information that crashes over us each and every day. Information that is often completely contradictory ‘Coffee is good for you… no, wait it’s bad for you… no, wait, it’s good for you again,’ rpt. ad nauseam.

I also pointed out some of the tricks, games and manipulations that are used to make medications seem far more effective than they truly are, or vice-versa. This, I have to say, can be a very dispiriting world to enter. When I give talks on this subject, I often start with a few quotes.

For example, here is Dr Marcia Angell, who edited the New England Journal of Medicine for over twenty years, writing in 2009:

“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgement 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 editor of the New England Journal of Medicine.”

Have things got better? No, I believe that they have got worse – if that were, indeed, possible. I was sent the following e-mail recently, about a closed door, no recording discussion, under no-disclosure Chatham House rules, in May of this year:

“A secretly recorded meeting between the editors-in-chief of The Lancet and the New England Journal of Medicine reveal both men bemoaning the ‘criminal’ influence big pharma has on scientific research.

“According to Philippe Douste-Blazy, France’s former Health Minister and 2017 candidate for WHO Director, the leaked 2020 Chatham House closed-door discussion between the [editor-in-chiefs] – whose publications both retracted papers favorable to big pharma over fraudulent data.

“Now we are not going to be able to, basically, if this continues, publish any more clinical research data because the pharmaceutical companies are so financially powerful today, and are able to use such methodologies, as to have us accept papers which are apparently methodologically perfect, but which, in reality, manage to conclude what they want them to conclude,” said Lancet [editor-in-chief] Richard Horton.

A YouTube video where this issue is discussed can be found here. It is in French, but there are English subtitles.

The New England Journal of Medicine, and the Lancet are the two most influential, most highly resourced journals in the world. If they no longer have the ability to detect what is essentially fraudulent research, then… Then what? Then what indeed?

In fact, things have generally taken a sharp turn for the worse since the COVID pandemic struck. New studies, new data, new information is arriving at breakneck speed, often with little or no effective review. What can you believe, who can you believe? Almost nothing would be the safest course of action.

One issue that has played out over the last few months, has stripped away any remaining vestiges of my trust in medical research. It concerns the anti-malarial drug hydroxychloroquine. You may well be aware that Donald Trump endorsed it – which presents a whole series of problems for many people.

However, before the pandemic hit, I was recommending to my local NHS trust that we should look to stock up on hydroxychloroquine. There had been a great deal of research over the years, strongly suggesting it could inhibit the entry of viruses into cells, and that it also interfered with viral replication once inside the cell.

This mechanism of action explains why it can help stop the malaria parasite from gaining entry into red blood cells. The science is complex, but many researchers felt there was good reason for thinking hydroxychloroquine may have some real, if not earth-shattering benefits, in COVID-19.

This idea was further reinforced by the knowledge that it has some effects on reducing the “cytokine storm” that is considered deadly with COVID. It is prescribed in rheumatoid arthritis to reduce the immune attack on joints.

The other reason for recommending hydroxychloroquine is that it is extremely safe. It is, for example, the most widely prescribed drug in India. Billions upon billions of doses have been prescribed. It is available over the counter in most countries. So I felt pretty comfortable in recommending that it could be tried. At worst, no harm would be done.

Then hydroxychloroquine became the centre of a worldwide storm. On one side, wearing the white hats, were the researchers who had used it early on, where it seemed to show some significant benefits. For example, Professor Didier Raoult in France:

“A renowned research professor in France has reported successful results from a new treatment for COVID-19, with early tests suggesting it can stop the virus from being contagious in just six days.”

Then research from Morocco:

“Jaouad Zemmouri, a Moroccan scientist, believes that 78% of Europe’s COVID-19 deaths could have been prevented if Europe had used hydroxychloroquine… “Morocco, with a population of 36 million, [roughly one-tenth that of the U.S.] has only 10,079 confirmed cases of Covid-19 and only 214 deaths.

“Professor Zemmourit believes that Morocco’s use of hydroxychloroquine has resulted in an 82.5% recovery rate from COVID-19 and only a 2.1% fatality rate – in those admitted to hospital.”

Just prior to this, a study was published in the Lancet, on May 22nd stating that hydroxychloroquine actually increased deaths. It then turned out that the data used could not be verified and was most likely made up. The authors had major conflicts of interest with pharmaceutical companies making anti-viral drugs. In early June, the entire article was retracted by Richard Horton, the Editor.

Then a UK study came out suggesting that hydroxychloroquine did not work at all. Discussing the results, Professor Martin Landray stated:

“This is not a treatment for COVID-19. It doesn’t work,” Martin Landray, an Oxford University professor who is co-leading the RECOVERY trial, told reporters. “This result should change medical practice worldwide. We can now stop using a drug that is useless.”

This study has since been heavily criticised by other researchers who state that the dose of hydroxychloroquine used was, potentially, toxic. It was also given far too late to have any positive effect. Many of the patients were already on ventilators.

Then, yesterday, I was sent a pre-proof copy of an article about to be published in the International Journal of Infectious Diseases which has found that hydroxychloroquine…

..“significantly” decreased the death rate of patients involved in the analysis. The study analyzed 2,541 patients hospitalized among the system’s six hospitals between March 10 and May 2 and found

  • 13% of those treated with hydroxychloroquine died while
  • 26% of those who did not receive the drug died.(ref)

When things get this messed up, I tend to look for the potential conflicts of interest. By which I mean, who stands to make money from slamming the use of hydroxychloroquine (which is a generic drug that has been around since 1934 and costs about £7 for a bottle of 60 tablets)?

In this case it is those companies who make the hugely expensive antiviral drugs such as Gilead Sciences’ Remdesvir – which costs $2,340 (£1877) for a typical five-day course in the US. Second, the companies that are striving to get a vaccine to market. There are billions and billions of dollars at stake here.

In this world, cheap drugs e.g., hydroxychloroquine, don’t stand much chance. Neither do cheap vitamins, such as vitamin C and vitamin D. Do they have benefits for COVID-19 sufferers? I am sure that they do. Will such benefits be dismissed in studies that have been carefully manipulated to ensure that they do not work? Of course. Remember these words:

‘…pharmaceutical companies are so financially powerful today, and are able to use such methodologies, as to have us accept papers which are apparently methodologically perfect, but which, in reality, manage to conclude what they want them to conclude,” said Lancet [editor-in-chief] Richard Horton.

Unless and until governments and medical bodies act decisively to permanently sever the financial ties between researchers and Big Pharma, these distortions and manipulation in the pursuit of Big Profit will continue.

Just please don’t hold your breath in anticipation.


The Lancet Study

11th December 2019

Several people have asked me to comment on a recent Lancet paper ‘Application of non-HDL cholesterol for population-based cardiovascular risk stratification: results from the Multinational Cardiovascular Risk Consortium.’ which made headlines around the world. Here – for example – from the BBC website:

What did the researchers find?

People should have their cholesterol level checked from their mid-20s, according to researchers. They say it is possible to use the reading to calculate the lifetime risk of heart disease and stroke.

The study, in The Lancet, is the most comprehensive yet to look at the long-term health risks of having too much “bad” cholesterol for decades. They say the earlier people take action to reduce cholesterol through diet changes and medication, the better.

They analysed data from almost 400,000 people from 19 countries and found a strong link between bad-cholesterol levels and the risk of cardiovascular disease from early adulthood over the next 40 years or more.

They were able to estimate the probability of a heart attack or stroke for people aged 35 and over, according to their gender, bad-cholesterol level, age and risk factors such as smoking, diabetes, height and weight, and blood pressure.

Report co-author, Prof Stefan Blankenberg, from the University Heart Center, Hamburg, said: “The risk scores currently used in the clinic to decide whether a person should have lipid-lowering treatment only assess the risk of cardiovascular disease over 10 years and so may underestimate lifetime risk, particularly in young people.” 1

The Daily Mail in the UK was a bit more excitable in its reporting

‘Adults ‘should have their cholesterol checked at 25’ because slashing it in the mid-30s can drastically reduce the risk of heart attacks and strokes

Researchers predicted huge 30-year risk profiles for heart disease and stroke, they found higher cholesterol in under-45s is more dangerous than in over-60s Even young people with healthy lifestyles ‘may benefit from knowing their risk.’ 2

My first thought, as always, is to look for the conflict of interest statement, just so you know how independent the researchers may be and make an estimate of potential bias.

My second thought was that this study did not look at cholesterol levels, or HDL levels, it looked at non-HDL cholesterol. An interesting thing to study. This is every form of liver derived lipoprotein that is not HDL, otherwise known as ‘good cholesterol’ or simply high-density lipoprotein.

Part of the reason for not looking at LDL, is that LDL is very rarely measured, or reported. Because the only way to measure LDL accurately is through ultracentrifuge, which is time consuming and expensive. Normally, the LDL levels are simply estimated using the Friedwald equation. To quote from the UK GP Notebook

‘… the ultracentrifugal measurement of LDL is time consuming and expensive and requires specialist equipment. For this reason, LDL-cholesterol is most commonly estimated from quantitative measurements of total and HDL-cholesterol and plasma triglycerides (TG) using the empirical relationship of Friedewald et al.(1972).

[LDL-chol] = [Total chol] – [HDL-chol] – ([TG]/2.2) where all concentrations are given in mmol/L (note that if calculated using all concentrations in mg/dL then the equation is [LDL-chol] = [Total chol] – [HDL-chol] – ([TG]/5))3

*TG = triglyceride

This means that the researchers will not have had any data on LDL levels for most people. The difficulty of directly measuring LDL is the reason why the risk calculators used in the UK and US do not even include LDL. These calculators are Qrisk3 and cvriskcalculator

So, it is important to note that this was not a study on LDL levels. Instead, it was a study on non-HDL levels. Which changes it into something completely different than was reported. Obviously, non-HDL levels bear some relationship to LDL, in that a higher LDL level will tend to raise the overall non-HDL cholesterol level.

However, and very importantly, non-HDL also includes the triglyceride (TG) level. Or at least the TG level divided by 2.2. This is important because a high triglyceride (TG) level, divided by 2.2 or not, is a strong indicator of insulin resistance, which leads to type II diabetes. Here is what WebMD has to say on the matter

‘High TG’s signals insulin resistance; that’s when you have excess insulin and blood sugar isn’t responding in normal ways to insulin. This results in higher than normal blood sugar levels. If you have insulin resistance, you’re one step closer to type 2 diabetes.’ 4

Insulin resistance, whether or not it has developed into type II diabetes, greatly increases your risk of both CVD and overall mortality, as outlined in the paper. ‘Triglyceride–to–High-Density-Lipoprotein-Cholesterol Ratio Is an Index of Heart Disease Mortality and of Incidence of Type 2 Diabetes Mellitus in Men.’

‘This study shows that a high TG/HDL-C ratio in men is a predictor of mortality from CHD and CVD. The TG/HDL-C ratio had a significant and higher HR [hazard ratio] for mortality from CHD and CVD than was found for the TyG index [fasting blood sugar]. These 2 measures, TG/HDL-C ratio and TyG index, similarly predicted incidence of type 2 diabetes, but the HR associated with a high TG/HDL-C seems to make the ratio a preferred single parameter of measurement.’ 5

You will get no argument from me that a high triglyceride level is going to indicate the underlying metabolic catastrophe that is insulin resistance. This, in turn, is going to greatly increase the risk of CVD and early death. But this will have nothing to do with the LDL level. So, it has nothing to do with ‘bad’ cholesterol. Instead is to do with triglycerides.

Therefore, this study is like looking at people who smoke, and who eat red meat, then stating that red meat consumption and smoking cause lung cancer. You have arbitrarily rammed two things together without making any effort to decided which causes what. Scientific nonsense.

There also some massive statistical problems with this study. Where, for example is overall mortality? Not mentioned. Not mentioned means it will not have been significant. Also, the use of a very wide and fuzzy ‘combined end-point.’ I have written about this many times, in many different places. It is a game played to claim statistical significance, where none really exists.

To try and explain as quickly as possible. The most powerful end-point is overall mortality i.e. how many people were dead in either group. Or, to be more positive, how many people were alive in either group.

After this come end-points of decreasing importance. For example, how many people died of CVD. This is clearly important, but if more people died of CVD in one group, yet they were less likely to die of cancer, the overall mortality could remain the same in both groups – even if CVD mortality were lower in one.

Group one

  • CVD deaths 150
  • Cancer death 150
  • Total deaths/mortality 300

Group two

  • CVD deaths 180
  • Cancer death 120
  • Total deaths/mortality 300

Net benefit = zero. But such results can often be hailed as a massive success for, say, a drug. For example, the ‘FOURIER’ study on Repatha (injectable LDL lowering agent) was hailed as a great success, despite overall mortality being higher in the Repatha arm. How, you may think, was this possible?

Well, the Fourier study had five end-points. Known as a ‘combined end-point’. [Mortality was not one of them.] The primary end point was the combined total of:

  • Cardiovascular death
  • MI (myocardial infarction)
  • Stroke
  • Hospitalization for unstable angina
  • Coronary revascularization

How can you have five different end-points as a primary end point? Well, you just can… apparently. 6

What you may notice, or maybe not, is that three of these are clinical events: cardiovascular death, MI and stroke. Two of them are clinical decisions. To admit someone to hospital for unstable angina, and to carry out a coronary revascularisation. Revascularisation is, essentially, putting in a stent to keep a coronary artery open.

So, the second two end-points are potentially subject to significant clinical bias. If someone has a low non-HDL cholesterol level, the decision may well be to not admit to hospital for unstable angina, and to not carry out coronary revascularisation. Why, because the physicians think they are protected by their low cholesterol.

[Guess which end-point dragged the FOURIER study into statistical significance.]

You think that clinical decisions are all objective. Then ask yourself why all clinical trials, wherever possible, are double-blinded (neither the patient or the doctor knows who is taking the drug, or the placebo)? This double blinding is considered essential to remove clinical bias. No blinding, bias introduced.

Even if you look at MIs and strokes, this diagnosis is less certain than you might wish. I have had many patients where it is entirely unclear if they have actually had a stroke or a heart attack. With a small stroke it is often, simply a guess. Low cholesterol, I guess not a stroke. High cholesterol, I guess that it is.

Just in case you think I am now talking nonsense, as I was writing this blog, I was sent a BBC report of a clinical trial done on stents in the US, which stated that stents were as safe as bypass surgery, with regard to MIs. However, the researchers decided to use a completely different system for diagnosing MI…

‘The trial called Excel started in 2010 and was sponsored by big US stent maker, Abbott. It was led by eminent US doctor Gregg Stone and aimed to recruit 2,000 patients. Half were given stents and the other half open heart surgery. Success of the treatments was measured by adding together the number of patients that had heart attacks, strokes, or had died.

The research team used an unusual definition of a heart attack, but had said that they would also publish data for the more common “Universal” definition of a heart attack alongside it. There is debate around which is a better measure and the investigators stand by their choice.

In 2016, the results of the trial for patients three years after their treatments were published in the prestigious New England Journal of Medicine. The article concluded stents and heart surgery were equally effective for people with left main coronary artery disease.

But researchers had failed to publish data for the common, “Universal” definition of a heart attack. Newsnight has seen that unpublished data and it shows that under the universal definition, patients in the trial that had received stents had 80% more heart attacks than those who had open heart surgery.

The lead researchers on the trial have told Newsnight that this is “fake information7

When is a heart attack not a heart attack? When it is measured by investigators in the clinical study – who have financial conflicts of interest.

Another problem is that, if you carry out a coronary artery revascularisation, there is a fifty per cent chance of triggering a heart attack. Usually pretty small and not clinically significant – but an MI, nonetheless. So, for each two additional revascularisations, you may get one more MI. Which further skews the statistics. [Not an issue in the FOURIER study where only the first event was counted].

Anyway, I hope you are getting the general message that a quintuple combined endpoint is, primarily, nonsense. Full of potential bias, particularly in an observational study. As the Lancet study was.

Finally, because I have run out of energy to spend another minute looking at this study, there is the issue of Lipoprotein(a). Otherwise known as Lp(a). This too forms part of the non-HDL cholesterol measurement.

Lp(a) and LDL are identical apart from the fact that Lp(a) has an additional protein attached to the side called apolipoprotein(a). This protein has a critical role in blood clotting and therefore Lp(a) can be viewed as a pro-coagulant agent – makes the blood clot bigger and more difficult to break down. Higher levels have long been linked to an increased risk of CVD.

Just to choose one quote from many thousands of studies about Lp(a): ‘Lipoprotein (a) and the risk of cardiovascular disease in the European Population: results from the BiomarCaRE consortium.’

Elevated Lp(a) was robustly associated with an increased risk for MCE (major cardiovascular events) and CVD in particular among individuals with diabetes. 8

Yes, you will have spotted the link with diabetes a.k.a. insulin resistance. So, a higher triglyceride level, added to raised Lp(a), further increases the risk of CVD.

So, with non-HDL cholesterol and Lp(a) we have another massive confounding factors built into the measurement. Again, I absolutely cannot disagree that raised Lp(a) increases the risk of CVD. I have written about it many, many times. Non-HDL cholesterol is a measure that contains Lp(a) within it…. You probably get the drift by now.

The whole paper, in my opinion, is complete nonsense. Assumptions, built on bias, built on a measure that has nothing much to do with LDL, or ‘bad’ cholesterol. Zoe Harcombe did a more forensic dissection of the paper. I like her ending:

‘The researchers assumed that a 50% reduction in non-HDL cholesterol could and would be achieved. The researchers assumed that a mathematical formula for risk reduction could be applied to that assumed 50% reduction in non-HDL cholesterol. The researchers’ assumed formula included the variable “number of years of treatment” and hence the formula produced a higher number, the earlier treatment started. The assumptions made it so.

The final paragraph of the paper stated: “However, since clinical trials investigating the benefit of lipid-lowering therapy in individuals younger than 45 years during a follow up of 30 years are not available, our study provides unique insights into the benefits of a potential early intervention in primary prevention.”

No, it doesn’t.’

Yet, there was no controlled clinical trial data to back this all up. There are only models and assumptions. Yet it made headlines around the world, as such stuff always does. Not only that, it made the wrong headlines.

As the BBC website stated: ‘The study, in The Lancet, is the most comprehensive yet to look at the long-term health risks of having too much “bad” cholesterol for decades’ Bad cholesterol is the bonkers, unscientific term that is used to describe LDL. This study did not look at ‘bad’ cholesterol… Scientific journalism at is finest.

My analysis. Crumple, throw, bin… forget.









Cholesterol Games

3rd March 2019

Mahatma Gandhi. ‘First they ignore you, then they laugh at you, then they fight you, then you win.’

A few days ago, the health editor of the Daily Mail wrote to me [and Zoe Harcombe and Aseem Malhotra]. I was informed that the Mail on Sunday was gong to attack us for daring to question the cholesterol hypothesis and the benefits of statins.

Below is the e-mail I received.

From: Barney Calman
Sent: 28 February 2019 16:53
To: malcolmken
Subject: MOS/Right to reply

Dear Dr Kendrick – The Mail on Sunday plans to publish an article this weekend on growing concerns about claims you and a number of other individuals have publicly made about statins, the role of cholesterol in heart disease, and the allegations that researchers into the drugs are financially conflicted due to payments made to the organisations they work for, and so the evidence they provide about the effectiveness of these medications, and their side effects, are in some way untrustworthy.

Over the past 30 years, more than 200,000 patients have been put through the most rigorous forms of clinical trials to produce definitive proof the tablets lower heart attack risk by up to 50 per cent, and a stroke by 30 per cent, and reduce the risk of death – from any cause.

In January, the editors-in-chief of all 30 major heart health medical journals – each a leading cardiologist – signed a joint open letter, warning: ‘Lives are at stake [due to the] wanton spread of medical misinformation. It is high time that this stopped.’

A 2016 analysis from the London School of Hygiene and Tropical Medicine, which tracks outbreaks and public health concerns, found fake news about statins may have prompted 200,000 patients in Britain alone to quit the drug over a single six-month period following an article you wrote for the BMJ which claimed, incorrectly, that 20 per cent of statins patients quit the drug because of side effects.

They estimate that up for 2,000 heart attack and strokes could be a result of this. We would like to offer you the opportunity to respond to this and the following:

*In your latest book, A Statin Nation, you state: ‘People are being conned. The way to avoid heart disease… has nothing to do with lowering cholesterol.’ This is despite clinical trial evidence to the contrary, and despite no evidence that there is a con, which would imply that those who claim that lowering cholesterol can help lower the risk of heart disease know this is untrue and are deliberately misleading the public.

*It has been alleged that the potential consequences of claims you have made about statins and cholesterol, far outweigh that of the infamous MMR vaccine scandal with one researcher saying: ‘In terms of death and disability that could have been prevented, this could be far worse.’

*In our article, one leading cardiologist states that the facts you and others often cite about cholesterol and statins sound convincing but that in reality ‘they contain a grain of truth, mixed with speculation and opinion, which makes is very difficult for the public to know who to trust.’

*You often quote observational studies as proof of your claims about statins and cholesterol in articles and in media appearances which contradict findings of authoritative clinical trials, which you do not mention. This is misleading.

*In a recent blog you wrote: ‘Professor Sir Rory Collins and Professor Colin Baigent made a pact with the dev… sorry … they made a pact with the pharmaceutical industry to take hold of all the data on statins. They will not let anyone else see the data they hold. Including all the data on side-effects. It is kept completely secret.’ Also: ‘A fact that needs to be emphasised is that the CTT will not let anyone else see the data they hold. Including all the data on adverse events [side-effects] and serious adverse events.’ It is a version of similar claims you have made numerous times over the years. However, the CTT have stated numerous times that they did not originally request the data on all adverse events so did not have it. They also point out that the said data must be requested from the individual research organisation which carries out the trials, and is not in their gift to provide. They say you know this, as they have told you this, so to repeat the claim amounts to a lie.

*Your stance on statins and the link between cholesterol and heart disease amounts to misinformation.

*There is no evidence you work in NHS practice, or as a GP in private practice.

If you wish for any comments to be included in our article please send them to us by midday this Friday.

Many thanks,

Barney Calman
Health & Lifestyle Content Director
Mail on Sunday


I wondered whether or not I should bother to reply, as I knew that the article would already have been written, and very little was going to be altered – no matter what I wrote. Indeed, I thought long and hard about responding to the allegation that there is no evidence you work in NHS practice, or as a GP in private practice.

This would have been a complete lie, so I wondered about letting them print it, then suing their backsides off afterwards. Then I thought I will spend the next ten years having people write that I am not a doctor at all – on the basis of a lie printed in the Daily Mail. So, I disavowed them of printing this direct lie. Maybe I should just have let them get on with it.

They were also going to write this…

A 2016 analysis from the London School of Hygiene and Tropical Medicine, which tracks outbreaks and public health concerns, found fake news about statins may have prompted 200,000 patients in Britain alone to quit the drug over a single six-month period following an article you wrote for the BMJ which claimed, incorrectly, that 20 per cent of statins patients quit the drug because of side effects.

Frankly, I wish I had written that paper, but I did not. It was written by Aseem Malhotra. This, I trust, gives you some idea of the high level of fact checking going on at the Daily Mail. In the end I did write back to the Daily Mail, and this is what I said. Amazingly, there were very few swear words.

Dear Barney Calman,

Thank you for your e-mail. This is all very familiar ground to me. I am not entirely sure how you would like me to respond to each of your points.

First, I do work for the NHS as a GP, and if anyone wishes to claim that I do not – then that would be direct libel. I am employed by two NHS trusts East Cheshire and CCICP (Central Cheshire Integrated Care Partnership). Feel free to check with either trust, or look me up on the GMC website. But if anyone states that I am not employed in the NHS then I will most certainly sue. And I will win, so I would recommend caution on this point.

As for other specific points.

*You often quote observational studies as proof of your claims about statins and cholesterol in articles and in media appearances which contradict findings of authoritative clinical trials, which you do not mention. This is misleading.

Do I not mention that the studies I quote are observational, or that I do not mention the findings of authoritative clinical trials? Which of these is a problem, and why?

I would add that the proof of the link between smoking and lung cancer was based on observational studies. Does this mean that smoking does not cause lung cancer? Or is that not their argument. Whilst observational studies are not generally considered as robust as randomised clinical trials, they have value. Equally, most epidemiologists would agree that, whilst observational studies (demonstrating association) cannot prove causality (unless the hazard ratios are very high) a lack of association does disprove causation. So, it can be fully valid to rely on observational studies where there is no association, or the observation is in direct contradiction to the hypothesis.

*It has been alleged that the potential consequences of claims you have made about statins and cholesterol, far outweigh that of the infamous MMR vaccine scandal with one researcher saying: ‘In terms of death and disability that could have been prevented, this could be far worse.’

If I am wrong, then this statement could, perhaps be true, although it does represent a form of reprehensible bullying – accusing someone of causing many thousands of deaths. This is an accusation that Rory Collins has repeatedly made. He attacked the BMJ for publishing an article suggesting statins may have a high incidence of adverse effects. You may wish to see the e-mail exchange between Rory Collins and Fiona Godlee on this site

I would also like to point you to a study published in the BMJ open Kristensen ML, et al. BMJ Open 2015;5:e007118. doi:10.1136/bmjopen-2014-007118

The main findings of this study – not refuted by anyone were…

6 studies for primary prevention and 5 for secondary prevention with a follow-up between 2.0 and 6.1 years were identified. Death was postponed between −5 and 19 days in primary prevention trials and between −10 and 27 days in secondary prevention trials. The median postponement of death for primary and secondary prevention trials were 3.2 and 4.1 days, respectively.

What this study found was that if you took a statin for five years, the increase in life expectancy would be (on average) 3.5 days. That is around 0.75 days per year of statin treatment. That is the important outcome. The figures quoted by Collins and Baigent and the Oxford CTT group are relative risk reductions, and these figures are entirely meaningless unless you know the absolute risk. Equally, to state lives can be saved is meaningless. No-one’s life can be saved. The best we can achieve is to increase life expectancy. That is what matters. I covered much of this in my book Doctoring Data, which I would recommend you read, as it outlines the ways that data are presented to look as beneficial as possible.

*In our article, one leading cardiologist states that the facts you and others often cite about cholesterol and statins sound convincing but that in reality ‘they contain a grain of truth, mixed with speculation and opinion, which makes is very difficult for the public to know who to trust.’

I cannot answer this, what does a grain of truth mean? What is a grain of truth mixed with speculation and opinion? Specific and concrete examples would be required before I could provide any meaningful answer.

*In your latest book, A Statin Nation, you state: ‘People are being conned. The way to avoid heart disease… has nothing to do with lowering cholesterol.’ This is despite clinical trial evidence to the contrary, and despite no evidence that there is a con, which would imply that those who claim that lowering cholesterol can help lower the risk of heart disease know this is untrue, and are deliberately misleading the public.

Yes, I believe that people are being conned, and I believe the public are being deliberately misled. That is why I called my first book The Great Cholesterol Con. I would point out that there has been one major placebo controlled double blind statin study done. ALLHAT-LLT, which was funded by the National Institutes of Health in the US. The conclusions of the study, published in 2002, were that:


Pravastatin did not reduce either all-cause mortality or CHD significantly when compared with usual care in older participants with well-controlled hypertension and moderately elevated LDL-C.

All of the industry funded studies were positive. This is either a remarkable coincidence – or something else. A con perhaps?

In a recent blog you wrote: ‘Professor Sir Rory Collins and Professor Colin Baigent made a pact with the dev… sorry … they made a pact with the pharmaceutical industry to take hold of all the data on statins. They will not let anyone else see the data they hold. Including all the data on side-effects. It is kept completely secret.’ Also: ‘A fact that needs to be emphasised is that the CTT will not let anyone else see the data they hold. Including all the data on adverse events [side-effects] and serious adverse events.’ It is a version of similar claims you have made numerous times over the years. However, the CTT have stated numerous times that they did not originally request the data on all adverse events so did not have it. They also point out that the said data must be requested from the individual research organisation which carries out the trials, and is not in their gift to provide. They say you know this, as they have told you this, so to repeat the claim amounts to a lie.

You could perhaps ask them to point you to any letter or any other form of communication that the CTT have had with me. I will let you know the answer, they have never communicated directly with me, at any time. So, for them to say that they have told me anything is, to be fully accurate, a lie. They claim do not hold the data, yet they have managed to publish major papers on statin adverse effects? For instance, this one. Interpretation of the evidence for the efficacy and safety of statin therapy.

Which contains sections such as these

‘The only serious adverse events that have been shown to be caused by long-term statin therapy—i.e., adverse effects of the statin—are myopathy (defined as muscle pain or weakness combined with large increases in blood concentrations of creatine kinase), new-onset diabetes mellitus, and, probably, haemorrhagic stroke. Typically, treatment of 10 000 patients for 5 years with an effective regimen (eg, atorvastatin 40 mg daily) would cause about 5 cases of myopathy (one of which might progress, if the statin therapy is not stopped, to the more severe condition of rhabdomyolysis), 50–100 new cases of diabetes, and 5–10 haemorrhagic strokes. However, any adverse impact of these side-effects on major vascular events has already been taken into account in the estimates of the absolute benefits. Statin therapy may cause symptomatic adverse events (eg, muscle pain or weakness) in up to about 50–100 patients (ie, 0·5–1·0% absolute harm) per 10 000 treated for 5 years.’

So, they have written a paper outlining all the issues of adverse effects and serious adverse effects – and yet they do not have the data. So, how did they manage that?

*Your stance on statins and the link between cholesterol and heart disease amounts to misinformation.

Perhaps you would like to read this paper (which I co-authored) ‘LDL-C does not cause cardiovascular disease: a comprehensive review of the current literature.’  Which was THE most downloaded paper published by Taylor and Francis in the last year.

Or this paper ‘Lack of an association or an inverse association between low-density-lipoprotein cholesterol and mortality in the elderly: a systematic review.’ Published in the BMJ open in 2016

‘High LDL-C is inversely associated with mortality in most people over 60 years. This finding is inconsistent with the cholesterol hypothesis (ie, that cholesterol, particularly LDL-C, is inherently atherogenic). Since elderly people with high LDL-C live as long or longer than those with low LDL-C, our analysis provides reason to question the validity of the cholesterol hypothesis. Moreover, our study provides the rationale for a re-evaluation of guidelines recommending pharmacological reduction of LDL-C in the elderly as a component of cardiovascular disease prevention strategies.

Which was the most read paper in the journal for five months in a row.

All I see from your e-mail are ad-hominem attacks on me. I see no facts at all.  I hope that I have given you sufficient information

Yours Truly

Dr.Malcolm Kendrick


I followed up with a section of the battle that Prof Sir Rory Collins had with Fiona Godlee over the publication of the Aseem Malhotra paper where Rory Collins demanded an apology and a retraction of the paper. The BMJ took this so seriously they held an independent review.

I wrote a second e-mail to Barney Calman

I would also point you to this paragraph

A 2016 analysis from the London School of Hygiene and Tropical Medicine, which tracks outbreaks and public health concerns, found fake news about statins may have prompted 200,000 patients in Britain alone to quit the drug over a single six-month period following an article you wrote for the BMJ which claimed, incorrectly, that 20 per cent of statins patients quit the drug because of side effects.

I did not write that article. I suggest you check your facts a little more closely before putting any article out there.

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

I would strongly suggest that you read it in full. It is, in a restrained manner, damning of Rory Collins and the CTT.

Here are a couple of sections from that report

All-cause mortality —A recent editorial by Vinay Prasad in Annals of Internal Medicine illustrates a fundamental problem that has consistently concerned the panel. Prasad compared two meta-analyses of statins in primary prevention that differed in their statistical conclusions by less than half a percentage point and yet reached opposite conclusions—namely that that “statins reduce . . . total mortality” or conversely that “data. .. showed no reduction in mortality associated with treatment with statins.” Unfortunately, patients and clinicians have to make decisions in the grey area between these two diametrically opposed conclusions. The panel supports Prasad’s contention that “The Cholesterol Treatment Trialists’ study has a robust set of de-identified individual-patient data, which can improve our understanding, and those data should be made widely available.

The conclusions of the BMJ report, which are carefully written are worth considering

The panel was unanimous in its decision that the two articles do not meet any of the criteria for retraction. The error did not compromise the principal arguments being made in either of the articles. These arguments involve interpretations of available evidence and were deemed to be within the range of reasonable opinion among those who are debating the appropriate use of statins. In making this assessment, the panel is not expressing an opinion about the merits of these arguments, as that work was beyond the scope of the panel.

The panel did have one final comment. It became clear to the panel that the fact that the trial data upon which this controversy is based are held by the investigators and not available for independent assessment by others may contribute to some of the uncertainty about risks and benefits. Different investigators may come to different conclusions with the same data. In fact, a particularly germane example occurred recently in which two experienced Cochrane groups were charged with evaluating a particular intervention and, despite being given the same instructions, data, and resources, did not arrive at identical results or conclusions. The panel strongly believes that the current debates on the appropriate use of statins would be elevated and usefully informed by making available the individual patient level data that underpin the relevant studies

Yours truly

Dr Malcolm Kendrick

P.S. employed to work in the NHS as a doctor – which is a fact.


In other words, the attacks on Aseem Malhotra were completely unfounded, as were the attacks on the BMJ. The whole issue of all-cause mortality is complex and there is a need for debate. Rory Collins and his team hold the robust set of de-identified data and those data should be made widely available. That would be the data they claim not to have?

How can it possibly be allowed that one group of researchers hold all the data from the statin trial (not, apparently the adverse effects data – although they have written detailed papers on this issue) and refuse to share it with anyone else?

Anyway, this is probably enough for now. I just wanted to give you some idea of the attacks and battles that are gong on and to shine a little light on what happens. The Mail on Sunday have published a very long article attacking ‘statin deniers’ with pictures of me Zoe and Aseem at the front. I think I look quite dashing. Not as dashing as Aseem who is a very handsome swine, and also young, and intelligent – and brave. Yes, I hate him.

Nor am I as attractive as Zoe Harcombe. But hey, at least I got my picture in the national press. I wasn’t very keen on the bit where they called me self-pitying. But I was quite pleased that they included some of the stuff that I sent.

Until next time, best wishes from the mass-murdering, statin denying, self-pitying Dr Kendrick.

Response to the Lancet paper

3rd February 2019

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

It was reported in various major newspapers.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

However, in reality, they both know full well.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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





Wikipedia a parable for our times

18th December 2019

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

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

I was not
I was
I am not
I care not

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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





Peter Gøtzsche – a scandal

19th September 2018

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

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

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

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

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

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

Here’s an excerpt:

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

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

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

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



Vendetta – The Tim Noakes affair

20th February 2018

[The high fat low carb conspiracy]

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

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

The tweets were:

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

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

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

Question One: does this constitute a medical consultation?

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

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

You would think that would have been the end of it. But no. The HPCSA obviously feels that the HPCSA is completely incompetent, so it appealed its own decision. You can read in more detail the utter ridiculousness of what it going on here:

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

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

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

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

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

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

Yes, really. Yes…really.

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

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

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

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

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

Tim Noakes found not guilty – of something or other

Many years ago I started looking at research into cardiovascular disease. Almost as soon as I began my journey, I came to recognise that many facts I had been taught in medical school were plain wrong. This did not come as a great surprise. Anyone familiar with the history of scientific research will soon find out that widely established facts are often not ‘true’ at all. My mother still likes to tell me that when she was at school it was taught, with unshakeable confidence, that there are 48 human chromosomes. There are 46.

In addition, it became clear that, not only were certain key facts wrong, there seemed to be a co-ordinated effort to attack anyone who dared to challenge them. One stand out example of such an attack was what happened to John Yudkin, the founder of the nutrition department at the University of London’s Queen Elizabeth College.

He did not believe that saturated fat was to blame for heart disease, the idea at the centre of the diet-hypothesis. At the time, this theory was being relentlessly driven by Ancel Keys, and it had gained widespread acceptance amongst the scientific community. In 1972 Yudkin wrote the book ‘Pure white and deadly’ in which he outlined why sugar was the probable cause of heart disease, not fat(s). He was then ruthlessly attacked. As outlined by the Telegraph:

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

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

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

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

Let us scroll forward some forty years or so, to Professor Tim Noakes. Regular readers of this blog will have heard of Tim Noakes who is, to quote Wikipedia.. ‘…a South African scientist, and an emeritus professor in the Division of Exercise Science and Sports Medicine at the University of Cape Town.

At one time he was a great supporter of the high carb low fat diet, and even helped to develop high carb energy foods for long distance runners. However, for various reasons (most importantly studying the science again) he completely changed his mind. He is now a very well-known proponent of the high fat, low carb (HFLC) diet, as a way to treat obesity and type II diabetes – and improve athletes’ performance.

A couple of years ago, he was dragged in front of the Health Professions Council of South Africa (HPCSA) after being charged with unprofessional conduct for providing advice to a breast-feeding mother in a tweet. “Baby doesn’t eat the dairy and cauliflower. Just very healthy high fat breast milk. Key is to wean [sic] baby onto LCHF.”

The case against him was obviously, and almost laughably, bogus. The HPCSA did not even (as I understand it) have any guidelines on what constitutes an on-line doctor patient relationship. You could make the case that it is difficult to find someone guilty of breaching rules, when there are no rules. Despite this, I thought they would get him on some technicality or other.

Just as happened to Gary Fettke in Australia

‘Prominent Launceston surgeon Gary Fettke has been banned from giving nutritional advice to his patients or the public for the rest of his medical career. He was recently notified by the Australian Health Practitioner Regulation Agency that he was not to speak about nutrition while he remained a medical practitioner.

Dr Fettke is a strong advocate for a low carb, high fat diet as a means to combat diabetes and ill-health. AHPRA told Dr Fettke “there is nothing associated with your medical training or education that makes you an expert or authority in the field of nutrition, diabetes or cancer”. It told him the ban was regardless of whether his views on the benefits of the low carbohydrate, high-fat lifestyle become accepted best medical practice in the future.’ 2

Lo, it came to pass that Gary Fettke cannot even talk about a high fat diet, even if it becomes accepted best medical practice…. Ho hum, now that really makes sense. At this point you may possibly, just possibly, see some parallels between Tim Noakes, an advocate of the high fat low carb diet in South Africa, and Gary Fettke, an advocate of the high fat low carb diet in Australia. Also, of course, John Yudkin, who was attacked and effectively silenced by the sugar industry many years ago.

This would be, I suppose, the very same sugar industry who paid Harvard researchers in the 1960s to write papers demonising saturated fat and extolling the virtues of sugar.

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

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

The findings come from documents recently found by a researcher at the University of San Francisco, which show that scientists at the Sugar Research Foundation (SRF), known today as the Sugar Association, paid scientists to do a 1967 literature review that overlooked the role of sugar in heart disease.3

A pattern does appear to emerge does it not?

With my views on diet, and cholesterol, and heart disease, and suchlike, I have often been accused of being a conspiracy theorist – which is just another way of saying that I am clearly an idiot who should shut up. I simply smile at people who tell me this, and say nothing. However, my motto is that…‘Just because you’re paranoid, it doesn’t mean they are not out to get you.’ In the case of the High Fat Low Carb advocates, they are out to get you, and there truly is a worldwide conspiracy to attack any silence anyone who dares criticise sugar/carbs in the diet.

The attacks and distortions have not stopped with the ‘Harvard researchers’, or John Yudkin, or Gary Fettke or Tim Noakes, they continue merrily today. In the Sunday Times of April 23rd 2017 an article appeared, entitled ‘Kellogg’s smothers health crisis in sugar – The cereals giant is funding studies that undermine official warnings on obesity.’ Just to choose a few paragraphs.

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

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

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

And so on and so forth. Interestingly, no-one from the world of nutrition has suggested that Kellogg’s should be dragged into court for distorting data, trying to discredit honest researchers, and paying ‘experts’ to speak on their behalf. It is the Golden Rule, I suppose. He who has the gold, makes the rules.

This all has obvious parallels to the tricks the tobacco industry got up to over the years. They did everything they could to hide the fact that cigarettes cause heart disease and cancer. Now the sugar industry, and those selling low fat high carb products, are trying to hide the fact that sugar/carbs are a key cause of obesity and type II diabetes.

And the techniques used by the sugar/cereal/high carb companies are drearily familiar – and sadly still highly effective. As with Yudkin, Noakes and Fettke, go for the man, not the ball (discredit the person, not their data). Dismiss any damaging evidence that does manage to emerge as ‘weak’, pay your own experts to write bogus reports, and create uncertainty everywhere. Some people should be very ashamed of themselves indeed. Instead, I suppose, they are getting massive bonuses.

The nutrition society of South Africa said, in response to the Noakes judgement: “We are glad that the hearing has been finalised after almost three years, unless there is an appeal. The judgement, however, has absolutely no bearing on the current or future status of nutrition or the dietary guidelines in South Africa.’4 So there, nyah, nyah, nyah. Any apology to Tim Noakes? No. Any apology for wasting huge sums of money on a court case they lost? No. Just a threat that they may appeal. They are not going to change a thing.

So, whilst Tim Noakes won his case, any scientist looking on gets a very clear message. If you say things we don’t like, we will attack you and drag you through court and make your life a living hell for three years. Now, that is how you silence people, just as they silenced Yudkin nearly forty years ago.






Medical censorship in the twenty first century

“If liberty means anything at all, it means the right to tell people what they do not want to hear.” George Orwell.

Many of you may be aware of an article published in the Lancet on the eighth of September. ‘Interpretation of the evidence for the efficacy and safety of statin therapy.’1 It caused a media stir, and I was asked to appear on a few BBC programmes to argue against it – tricky in two minutes. At one stage I was cut off when I attempted to bring up the issue of financial conflicts of interest amongst the authors. The lead author of this paper was Professor Sir Rory Collins.

In truth, I have been awaiting this article for some time. In fact, I am going to reproduce here a blog I wrote on February 16th 2015, predicting exactly what was going to happen, who was going to be involved, and (in broad terms) exactly what they were going to say:

A humiliating climb down – or a Machiavellian move?

Some of you may have seen a headline in the Sunday Express Newspaper ‘Statin, new safety checks.’ The subheading was ‘Oxford professor who championed controversial drug to reassess evidence of side effects.’

Those of you who read this blog probably know that the professor in question is Sir Rory Collins. He, more than anyone, has championed the ever wider prescription of these drugs. He has also ruthlessly attacked anyone who dares make any criticism of them.

You may remember that last year he tried to get the BMJ to retract two articles claiming that statins had side effects (correctly called adverse effects, but I will call them side-effects to avoid confusion) of around 18 – 20%.

He stated that these articles were irresponsible, worse than Andrew Wakefield’s work on the MMR vaccine, and that thousands would die if they were scared off taking their statins by such articles. Ah yes, the old ‘thousands will die’ game. A game I have long since tired of.

Is this story ringing any bells yet? The truth was that both articles quoted a paper which stated that 17.4% of people suffered adverse effects. So, yes, a pedant would say that the 18 – 20% figure was wrong – although not very wrong. Certainly not worth a demand of instant retraction, and apology, which is a very drastic step indeed.

Anyway, below is a short description of the findings of an independent panel set up by Fiona Godlee, editor of the BMJ, regarding the Rory Collins attacks:

“As previously reported, Rory Collins, a prominent researcher and head of the Cholesterol Treatment Trialists’ (CTT) Collaboration, had demanded that The BMJ retract two articles that were highly critical of statins. Although The BMJ issued a correction for both papers for inaccurately citing an earlier publication and therefore overstating the incidence of adverse effects of statins, this response did not satisfy Collins. He repeatedly demanded that the journal issue a full retraction of the articles, prompting The BMJ’s editor-in-chief, Fiona Godlee, to convene an outside panel of experts to review the problem.

The report of the independent statins review panel exonerates The BMJ from wrong doing and said the controversial articles should not be retracted:

“The panel were unanimous in their decision that the two papers do not meet any of the criteria for retraction. The error did not compromise the principal arguments being made in either of the papers. These arguments involve interpretations of available evidence and were deemed to be within the range of reasonable opinion among those who are debating the appropriate use of statins.”

In fact, the panel was critical of Collins for refusing to submit a published response to the articles:

“The panel noted with concern that despite the Editor’s repeated requests that Rory Collins should put his criticisms in writing as a rapid response, a letter to the editor or as a stand-alone article, all his submissions were clearly marked ‘Not for Publication’. The panel considered this unlikely to promote open scientific dialogue in the tradition of the BMJ.””1

To provide a bit more context at this point, you should know that for a number of years, people have been trying to get Rory Collins to release the data he and his unit (the CTT), holds on statins. [The CTT was set up purely to get hold of and review all the data on statins, it has no other function].

He has stubbornly refused to let anyone see anything. He claims he signed non-disclosure contracts with pharmaceutical companies who send him the data, so he cannot allow anyone else access. Please remember that some of the trials he holds data on were done over thirty years ago, and the drugs are long off patent. So how the hell could any data still be ‘confidential’ or ‘commercially sensitive’ now?

[The concept that vital data on drug adverse effects can be considered confidential, and no-one is allowed to see it, is completely ridiculous anyway. But that is an argument for another day.]

Now, amazingly, after running the CTT for nearly twenty years, Collins claims that ‘he has not seen the full data on side-effects.’ In an e-mail to the Sunday Express he stated that ‘his team had assessed the effects of statins on heart disease and cancer but not other side effects such as muscle pain.

Let that statement percolate for a moment or two. Then try to make sense of it. So, they have got the data, but not bothered to look at it? Or they have not got it – which surely must be the case if he hasn’t even seen it. Give us a clue. Either way, Collins states he has not assessed it.

Despite this, he still managed a vicious attack on the BMJ for publishing articles, claiming statins had side effects of around 20%. This was an interesting stance to stake, as he now claims he has no idea what the rate of side effects are? In which case he should make a grovelling apology to Fiona Godlee immediately.

What is certain, and must be reiterated, is that Rory Collins has consistently refused to allow anyone to see the side effect data, or any other data, that that the CTT may, or may not, hold. See e-mail below from Professor Colin Baigent to the ABC producer MaryAnne Demasi (she was trying to get the CTT to confirm that they would not release data, Colin Baigent is, or was, deputy to Rory Collins)

From: colin.baigent@xxxxxxxxxxx

To: maryannedemasi@xxxxxxxxxxxx


Date: Tue, 24 Sep 2013 17:02:23 +0000

Dear Maryanne

The CTT secretariat has agreement with the principal investigators of the trials and, in those instances where trial data were provided directly by the drug manufacturers, with the companies themselves, that individual trial data will not be released to third parties. Such an agreement was necessary in order that analyses of the totality of the available trial data could be conducted by the CTT Collaboration: without such an agreement the trial data could not have been brought together for systematic analysis. Such analysis has allowed the CTT Collaboration to conduct and report all of the analyses on efficacy and safety that have been sought directly or indirectly by others (eg by Dr Redberg in her papers on the efficacy and safety of statins in primary prevention, and in questions raised by the Cochrane Collaboration). Hence, the CTT Collaboration has made available findings that would not otherwise have emerged.

I would be very happy to ring you at whatever time is convenient for you in order to help you to understand our approach, and then address in writing any residual concerns. It would be a shame if we were not able to speak as this would be the most effective way of explaining things.

Please let me know where and some times when I can reach you, and I will endeavour to telephone.

Colin Baigent.

I put the word safety in bold in this copied e-mail. You will note that Professor Colin Baigent does not say that that the CTT do not have these data on safety. He just says that the CTT won’t let anyone else see any data.

If they do have it, why have they not done this critically important review before, as they have had much of the data for over twenty years. If they don’t have it, how exactly is Rory Collins going to review it – as he states he is going to? Sorry to keep repeating this point, but I think it is absolutely critical.

Picture the scene in a lovely oak panelled office in Oxford, the city of the dreaming spires….

Professor Collins:             ‘Hey guys, you’re just not going to believe this, but a researcher just found a big box in the airing cupboard, and guess what, it has all the safety data in it….phew.’

Professor Baigent:           ‘Ahem… Why that’s lucky Professor Collins, now we can do the safety review.’

Professor Collins:             ‘Ahem… Indeed, Professor Baigent, we can. So, let’s get cracking shall we?’

And lo it has come to pass that after all these years Professor Collins has deigned to look at the safety data. This review shall, in Collins own words ‘be challenging.’ But you know what. I really don’t think they should bother, because we all know exactly what they are going to find….

That they were right all along, statins have no side effects. Hoorah, pip, pip. Nothing to see here, now move along.

A.N.Other Researcher:                    ‘Please sir, can anyone else see these data that you hold, to ensure that you are being completely open and honest?’

Professor Collins:                               ‘Don’t be ridiculous, these data are completely confidential.’

At this point I feel that I should ask how much do you, gentle readers, believe you can trust a review by Collins, on the data that Collins holds, on behalf of the pharmaceutical industry. Data that no-one else can ever see. [And the data from clinical trials on side effects is totally inadequate anyway].

Were I to be given the task of finding someone to review the safety data on statins, Professor Sir Rory Collins would not be the first person I would ask. He might even be the last.


P.S. Actually, he would be the last.

I do not claim to be Nostradamus here. What was going to happen was obvious. The script had been written a long time ago. It was only a question of when, not if, it happened.

However, whilst the article itself is nothing new… and believe me, there is nothing new here. Just the same data stretched into three hundred references, and mind-blowing statistical obfuscation. It does, however, contain a few new Alice in Wonderland statements, such as the following:

‘If information on a particular outcome is not available from a randomised trial because it was not recorded, that would not bias assessment of the effects of the treatment based on trials that did record that outcome.’ How can this statement be made? For the first twenty years of trials on statins, no-one had noted that statins increase the risk of type II diabetes. It was not, as far as could be seen at the time, a problem.

Then, in a later study, JUPITER, all of a sudden it was found that there was a significant increase in type II diabetes. Now, it turns out that all statins increase the risk of type II diabetes. Had JUPITER not recorded the incidence of type II diabetes, this would never have been noticed. The cynics among you might say that they recorded this in the hope that the incidence would actually go down.

Here we have a perfect example of an outcome not recorded in the vast majority of statin studies. Had it been, it would have significantly biased the assessment of treatment. We also find that after two trials, 4S and HPS, found an increase in non melanoma skin cancer2, this outcome was not recorded, ever again, in statin trials. Outcomes certainly cannot make a difference if you do not record them. But if you did bother record them – who knows what might have happened.

This type of logic litters this Lancet paper, along with straw man argument after straw man argument. However, the purpose of this blog was not to discuss the evidence, such as it is, such as we are allowed to see, but to highlight why this paper was written and published. For this I shall turn to the editorial, accompanying the paper, written by Richard Horton. Who is the editor of The Lancet.

Read this, and be afraid, for it is the most frightening thing you will read this year. Possibly this decade and maybe the entire century as is a direct attack on human freedoms. Whilst couched in the usual life destroying scientific prose, what he is saying is that any who questions current accepted medical dogma should be very tightly controlled, and probably should not be allowed to publish anything at all.

The entire editorial is an exercise in trying to silence any dissent with what some might view as threats and bullying. This, I think, is the key paragraph (my emphasis in bold).

‘The debate about statins, as for MMR, has important implications for journals. Some research papers are more high risk to public health than others. Those papers deserve extra vigilance. They should be subjected to rigorous and extensive challenge during peer review. The risk of publication should be explicitly discussed and evaluated. If publication is agreed, it should be managed with exquisite care.’

Now that, when you strip it down, is basically censorship.

Despite the seriousness of what Richard Horton is proposing, it is amusing to know what his published views on peer review might be, consider his statement that ‘Those papers deserve extra vigilance. They should be subjected to rigorous and extensive challenge during 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.’

Anyway, you can read the editorial in full here ( In addition to the paragraph highlighted above, I would like to draw your attention to a couple of other very worrying statements in the closing parapgraphs:

The Committee’s [Committee on Publication Ethics COPE] decision [not to investigate statin critics as demanded by ‘concerned’ scientists] points to a serious gap in UK science—the lack of a central institution where scientists who wish to question the actions or ethics of other scientists or scientific institutions can go. Allegations of research misconduct are best investigated by the institution where the original research took place. But that principle does not apply for some organisations, such as scientific or medical journals.

With no independent tribunal to consider allegations of research or publication malpractice, a damaging dispute has been allowed to continue unresolved for 2 years, causing measurable harm to public health.

The debate about statins, as for MMR, has important implications for journals. Some research papers are more high risk to public health than others. Those papers deserve extra vigilance. They should be subjected to rigorous and extensive challenge during peer review. The risk of publication should be explicitly discussed and evaluated. If publication is agreed, it should be managed with exquisite care.

Authors and editors should be aligned on the messages they wish to convey, and every eff ort must be made to avoid misinterpretations and misunderstandings in the media. Editors also have to separate their roles as gatekeepers and campaigners. It is tempting to publish science that confirms pre-existing beliefs, especially if those beliefs underpin a campaign. Two ongoing campaigns—against Too Much Medicine and for Statin Open Data—continue to imply that statins are overused and that hidden harms remain to be exposed. As the Review we publish makes clear, the best available evidence indicates that neither statement is true.

Would this be the same Richard Horton, editor of the Journal, the Lancet,  who wrote? ‘Journals have devolved into information laundering operations for the pharmaceutical industry.’3

Would this be the Richard Horton who said? “The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness.”4

And would this be the same man who followed it up with?

‘The apparent endemicity of bad research behaviour is alarming. In their quest for telling a compelling story, scientists too often sculpt data to fit their preferred theory of the world. Or they retrofit hypotheses to fit their data. Journal editors deserve their fair share of criticism too. We aid and abet the worst behaviours. Our acquiescence to the impact factor fuels an unhealthy competition to win a place in a select few journals. Our love of “significance” pollutes the literature with many a statistical fairy-tale. We reject important confirmations. Journals are not the only miscreants. Universities are in a perpetual struggle for money and talent, endpoints that foster reductive metrics, such as high-impact publication.’4

Couldn’t have put it better myself. Yet, despite the fact that Richard Horton knows that much of the research is flawed and distorted by ‘flagrant conflicts of interest’ he still seems to believe that the statin studies, uniquely in history, are perfect – and cannot be questioned in any way. “Doublethink means the power of holding two contradictory beliefs in one’s mind simultaneously, and accepting both of them.” (George Orwell).

What do other editors think of this latest paper? Well, we have the thoughts of Fiona Godlee (editor of the BMJ), and Rita Redberg (editor of the Journal of the American Medical Association). I will supply a few quotes from them in an article published in Medpage Today (

‘More generally, Godlee and Redberg lamented the absence of independent verification of the statin data. Redberg said that “none of the CTT data has been made available to other researchers, despite multiple requests.” “No one has seen these data except the trialists.” Godlee agreed. “Ideally all clinical trial data should be available for third-party scrutiny,” she said.

Godlee’s also noted that “this is not an independent review, this is a review by the trialists.” Redberg went further, saying that “the long declaration of interests is telling. The Oxford Clinical Trials Unit receives hundreds of millions of pounds of support from the pharmaceutical industry.”

Godlee said that the need for independent review is especially pressing in this case, given the public health implications of the call for widespread use of statins for primary prevention. Redberg went even further and observed that “all of this data is from industry-sponsored studies, with concern for bias.”

As they went on to say

‘Redberg also pointed out some unintended consequences of statin usage. “Data shows that people on statins are more likely to become obese and more sedentary over time than non-statin users, likely because people mistakenly think they don’t need to eat a healthy diet and exercise as they can just take a pill to give them the same benefit (Sugiyama et al. JAMA IM 2014). So it seems this review affirms that many healthy people who feel perfectly well can take a pill every day, not live any longer, suffer any number of adverse effects, all to treat the ‘disease’ of LDL. I maintain the best way to reduce cardiac risk is to eat a Mediterranean-style diet, get regular physical activity, don’t smoke, and enjoy yourself.”

Godlee also emphasized the limitations of primary prevention. “Evidence about poor adherence to statins has long been known,” said Godlee. “People don’t want to take a drug forever. The problem didn’t arise with the BMJ study.”

It also seems likely that the Lancet paper exaggerated the benefits of primary prevention. The long-term benefits of primary prevention in the paper were based on modeling. The calculated benefits might have been a best-case scenario.’

In short, they did not think much of this paper, and Fiona Godlee was particularly concerned about the censorship element:

‘Godlee rejected the comparison of the BMJ papers to the Lancet Wakefield paper and objected to the idea that it’s too dangerous to publish papers critical of statins. “Where do you stop and where does that begin?” she wondered. She also pointed out that public concern over statins in the U.K. became elevated, not after the publication of the BMJ papers, but after Collins brought attention to the papers in a public denunciation of the papers on the BBC.

“We have to allow debate, I don’t know where you would draw the line,” she said. “In terms of public debate, the statin debate is fascinating and deserves airing.”

So, thank goodness for them. I shall stop now, although there is much still to say, because this blog is already very long and people may fall asleep reading it. However, I think this is such an important issue – potential censorship in medical research – that I felt I absolutely had to write something. So, here it is.

I shall finish on two things. Firstly, to state the Uffe Ravnskov, who has been a long-term campaigner against the cholesterol hypothesis, and statins, had one of his books, burned, during a live television debate. I do not have any footage, but here is my attempt to replicate the scene using a photograph from the past.


Secondly, here is a list of some of the conflicts of interest of the authors of the paper.

Declaration of interests

JA, CB, LB, RC, JE, RP, DP, and CR work in the Clinical Trial Service Unit & Epidemiological Studies Unit (CTSU) at the University of Oxford. The CTSU has received research grants from Abbott, AstraZeneca, Bayer, GlaxoSmithKline, Merck, Novartis, Pfizer, Roche, Schering, and Solvay that are governed by University of Oxford contracts that protect its independence, and it has a staff policy of not taking personal payments from industry (with reimbursement sought only for the costs of travel and accommodation to attend scientific meetings). RC is co-inventor of a genetic test for statin-related myopathy risk, but receives no income from it. DP has participated in advisory meetings for Sanofi related to PCSK9 inhibitor therapy in his previous employment. The CTT Collaboration, which is coordinated by CTSU with colleagues from the University of Sydney, does not receive industry funding. JD has received research grants from, and served as a consultant to, Merck and Pfizer. GDS hast twice received travel and accommodation funding and honoraria from Merck; DD receives compensation for serving on data monitoring committees for clinical trials (including of statins) funded by Abbvie, Actelion, Amgen, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Merck, Sanofi , and Teva. NW and ML are inventors of a combination formulation for the prevention of cardiovascular disease that includes a statin, covered by patents licensed to Polypill in which they both hold shares and which owns the website SMac has received research grants for research on statins and polypill development from Bristol-Myers Squibb and BUPA. SMar is co-inventor on a pending patent for a LDL cholesterol estimation method, and has served as an advisor to Sanofi, Regeneron, Quest Diagnostics, Pressed Juicery, and Abbott Nutrition. NP has received research grants and honoraria for participating in advisory meetings and giving lectures from Amgen, Lilly, Menorini, and Merck. PR has received investigator-initiated research grants from Amgen, AstraZeneca, Kowa, Novartis, and Pfizer. PSa has received research grants and honoraria for consultancies from Amgen and Pfizer. LS has undertaken advisory work unrelated to statins for AstraZeneca and GlaxoSmithKline. SY has received a research grant from AstraZeneca through Hamilton Health Sciences. AR declares that George Health Enterprises, the social enterprise arm of The George Institute, has received investment to develop combination products containing statin, aspirin, and blood-pressure-lowering drugs. JS has received grants from the National Health and Medical Research Council, Australia; Bayer Pharmaceuticals; Roche; and Merck Serono. RB, SE, BN, IR, and PSa declare no competing interests.

[This list is far from complete. Paul Ridker, for example was (and may still be) a board member of Merck Sharp and Dohme, the maker of simvastatin at the time. Something he failed to report in a paper entitled: ‘Association of LDL Cholesterol, Non-HDL Cholesterol and Apolipoprotein B level with risk of cardiovascular events among patients treated with statins: A meta-analysis.’6 And something he has not mentioned here either.]


1: Published online September 8, 2016

2: Hung SH, Lin SC, Chung SD. Statins use and thyroid cancer: a population based case-control study. Clin Enodocrinol (Oxf) 2014 published online 30 July 2014,doi:10.111/cen.12570

3: Richard Smith. “Medical journals are an extension of the marketing arm of pharmaceutical companies.” Public library of Science. (May 17, 2005).

4: Vol 385 April 11, 2015


6: Correction. “Unreported Financial Disclosures in: Association of LDL Cholesterol, Non-HDL Cholesterol, and Apoliprotein B levels with risk of cardiovascular events among patients treated with statins: a Meta-analysis.’ JAMA. (April 25, 2012].

What causes heart disease – part XIII

Heart disease and inflammation.

A few people have sent me links to a recent paper called ‘Inflammation and Atherosclerosis.’ This was published in Circulation, and the authors were: Peter Libby, MD; Paul M. Ridker, MD; Attilio Maseri, MD. Remember two of the names.

Here is a relatively long section of the abstract:

‘Atherosclerosis, formerly considered a bland lipid storage disease, actually involves an ongoing inflammatory response. Recent advances in basic science have established a fundamental role for inflammation in mediating all stages of this disease from initiation through progression and, ultimately, the thrombotic complications of atherosclerosis. These new findings provide important links between risk factors and the mechanisms of atherogenesis.

Clinical studies have shown that this emerging biology of inflammation in atherosclerosis applies directly to human patients. Elevation in markers of inflammation predicts outcomes of patients with acute coronary syndromes, independently of myocardial damage. In addition, low-grade chronic inflammation, as indicated by levels of the inflammatory marker C-reactive protein, prospectively defines risk of atherosclerotic complications, thus adding to prognostic information provided by traditional risk factors.

Moreover, certain treatments that reduce coronary risk also limit inflammation. In the case of lipid lowering with statins, this anti-inflammatory effect does not appear to correlate with reduction in low-density lipoprotein levels. These new insights into inflammation in atherosclerosis not only increase our understanding of this disease, but also have practical clinical applications in risk stratification and targeting of therapy for this scourge of growing worldwide importance.

This paper interested me for a number of reasons. I focused down for a few moments on the phrase ‘Atherosclerosis, formerly consider a bland lipid storage disease…’ Does this mean that the world is moving on… Atherosclerosis has nothing to do with lipids e.g. LDL a.k.a. ‘bad cholesterol’? Now that would be something. Especially as it was published in the mainstream CV journal ‘Circulation.’

It seems that these authors are trying to shift the thinking away from cholesterol to inflammation. However, before discussing anything else I wanted to point out something that most people may have missed – by looking at a bit of background on the authors. First, Paul Ridker, who ran the JUPITER study, and who is a hugely influential cardiologist.

It should be noted that Paul Ridker has a major interest in moving thinking about atherosclerosis from a lipid storage disorder to an inflammatory condition. Because he has patent on the high sensitivity CRP test (C-reactive protein).

‘Dr Ridker is named as a coinventor on patents filed by the Brigham and Women’s Hospital that relate to the use of inflammatory markers in cardiovascular disease.’

What this means is that every time someone uses a high sensitivity CRP test, Paul Ridker becomes a little bit richer. However, in this paper, this massive financial conflict of interest is not mentioned. Instead, we get Acknowledgements:

This work was supported in part by grants from the National Heart, Lung, and Blood Institute to Drs Libby (HL-34636, HL-48743, and HL-56985) and Ridker (HL-58755 and HL-63293), and by the Leducq Foundation (to Drs Libby and Ridker). Dr Ridker is also supported by a Distinguished Scientist Award from the Doris Duke Foundation. Dr Maseri is supported by a grant from Fondazione Internazionale di Ricerca Per il Cuore onlus

No conflicts Dr Ridker? Mind you, Paul Ridker does have considerable form in not disclosing his financial conflicts. Some years ago, the Journal of the American Medical Association JAMA, was forced to publish a statement on ‘Unreported Financial Disclosures’ that were spotted in paper ‘Associations of LDL, Cholesterol, Non-HDL Cholesterol, and Apolipoprotein B levels With Risk of Cardiovascular Events Among Patients Treated with Statins: A meta-analysis.’

This statement mentioned many, many conflicts that the authors had failed to mention at the time. The section on Dr Ridker reads thus:

‘…Dr Ridker reports board membership of Merck Sharp and Dohme and receipt of a grant or pending grant to his institution from Amgen.’ [Amgen, as you may know are pushing PCSK-9 inhibitors]. This is covered in my book Doctoring Data.

Just to spell this out in a little more detail, Paul Ridker was an author on a meta-analysis of statins, yet failed to report that he was a board member of a pharmaceutical company (Merck) that marketed statins.

In truth, the moment I saw a paper promoting the ‘new idea’ that atherosclerosis is all due to inflammation, my antennae started to twitch. Especially when I knew that Paul Ridker was involved. A man who holds patents on a test for the inflammatory marker that we should be using.

I then immediately wondered, Is Paul Ridker now running a clinical trial on behalf of a pharmaceutical company, looking at the use of an anti-inflammatory agent to treat CVD. So, I had a little look round the internet. And guess what. Paul Ridker is, indeed, running a trial on an ant inflammatory for the treatment of CVD. The CANTOS study If you look down the list those on the committee running this study, you will find that Peter Libby is also on the steering committee. A conflict that remained unmentioned in the Circulation paper either.

What is the drug, it is Canakinumab. Here, from Wiki:

Canakinumab (INN, trade name Ilaris, previously ACZ885) is a human monoclonal antibody targeted at interleukin-1 beta. It has no cross-reactivity with other members of the interleukin-1 family, including interleukin-1 alpha.

Canakinumab was approved for the treatment of cryopyrin-associated periodic syndromes (CAPS) by the U.S. Food and Drug Administration (FDA) on June 2009[4] and by the European Medicines Agency in October 2009.CAPS is a spectrum of autoinflammatory syndromes including familial cold autoinflammatory syndrome, Muckle–Wells syndrome, and neonatal-onset multisystem inflammatory disease.

Canakinumab was being developed by Novartis for the treatment of rheumatoid arthritis but this trial was completed in October 2009. Canakinumab is also in phase I clinical trials as a possible treatment for chronic obstructive pulmonary disease, gout and coronary artery disease. It is also in trials for Schizophrenia. In gout it may result in better outcomes than a low dose of a steroid but costs five thousand times more.

I thought I would highlight the final sentence, just to give you some idea of the potential cost of this drug, should it ever be marketed for the treatment of CVD.

I know that this may seem a diversion. However, I have been around the world of cardiovascular research for long enough to take nothing at face value. Here is a paper suggesting that atherosclerosis has little or nothing to do with lipids. It is primarily due to inflammation. Which is a reasonable hypothesis. But guess what, one of the authors has a patent for an inflammatory marker. He and another author are running a clinical study, funded by Novartis, on the use of an anti-inflammatory agent in CVD.

However, just because there is money in the background, it does not necessarily mean that everything written is wrong. Perhaps inflammation truly is the underlying cause of atherosclerosis. Many other people have been saying this for years. Some of them, I know, certainly believe it from a purely objective scientific perspective. For example, Duane Graveline – who writes a great deal about CVD on his blog, and is also a friend. He fully believes that atherosclerosis is an inflammatory condition, and he has no horse in the race.

My own take on this matter is slightly different. Yes, if you have a high C-reactive protein (CRP) level, this means that there is inflammation going on within the artery, and this is a sign of increased CVD risk. This is true, but what does it mean? Is the inflammation causing the CVD?

Whenever I see anyone stating that inflammation is a cause of anything I simply change the word inflammation to the word ‘healing,’ to see how sensible it then sounds. Inflammation is, in most cases, the way the body heals itself after injury. If you twist your ankle, it will become swollen and inflamed. The injury comes first, then you get the inflammation/healing. You would be hard pressed to state that inflammation causes twisted ankles.

Of course, there are some conditions where the inflammation itself can become greater than the original problem. Just to name three: Asthma, Crohn’s disease and Rheumatoid arthritis. In these diseases the body’s inflammatory/healing system becomes revved up, and starts attacking itself. This out of control inflammation can then lead to further problems downstream e.g. joint destruction. Such conditions are often ‘treated’ or controlled by anti-inflammatory agents e.g. steroids.

Equally, if you have Systemic Lupus Erythematosus (SLE), this is an ‘inflammatory’ disease, and you also have a severe vasculitis (inflammation of vasculature). As mentioned before SLE can raise the risk of CVD, in young women, by up to five thousand per cent. Case proven? Inflammation causes atherosclerosis?

No, I don’t think so. The sequence in SLE is that the vasculature is damaged (the endothelium is damaged). This stimulates the body to try and heal the damage. The healing is what we call inflammation and the C-reactive protein level goes up.

Get rid of the inflammation, and you will not be treating anything. You will simply be interfering with the healing process, and the CVD will, most likely, accelerate. Even if C-reactive protein levels go down, along with any observable inflammatory action.

If I may return for a moment or two to twisted ankles. To quote Dr Mirkin:

‘When I wrote my best-selling Sports medicine Book in 1978, I coined the term RICE (Rest, Ice, Compression, Elevation) for the treatment of athletic injuries. Ice has been a standard treatment for injuries and sore muscles because it helps to relieve pain caused by injured tissue. Coaches have used my “RICE” guideline for decades, but now it appears that both Ice and complete Rest may delay healing, instead of helping.’

As he goes on to say:

‘Anything That Reduces Inflammation Also Delays Healing [I cannot resist stating that, this is because inflammation is healing]

Anything that reduces your immune response will also delay muscle healing. Thus, healing is delayed by:

  • cortisone-type drugs,
  • almost all pain-relieving medicines, such as non-steroidal anti-inflammatory drugs like ibuprofen
  • immune suppressants that are often used to treat arthritis, cancer or psoriasis,
  • applying cold packs or ice, and
  • anything else that blocks the immune response to injury.’

At least Dr Mirkin has had the grace to admit that he was wrong. RICE reduces inflammation, but interferes with healing.

I am pretty certain that exactly the same thing will happen with ‘inflammation’ in CVD. I can state this with relative confidence, because the most powerful anti-inflammatory agent known to man are steroids/corticosteroids. Corticosteroids e.g. prednisolone, or hydrocortisone are potent anti-inflammatory agents, they are all based on the natural stress hormone cortisol – produced in the adrenal glands. Steroids = corticosteroids = cortisol (just about).

Cushing’s disease is a disease whereby too much cortisol is produce in the adrenal glands, usually due to a small tumour that overproduces the hormone. So, if you have Cushing’s disease, you have a powerful anti-inflammatory agent coursing through your blood vessels – at all times. And what is the effect of this on CVD?

‘In patients with Cushing’s syndrome (CS) cardiovascular complications determine a mortality rate four times higher than in an age- and gender-matched population.’

The same thing happens when you prescribe steroids, for various conditions:

‘Individuals who use glucocorticoids and exhibit iatrogenic (caused by the medicine) Cushing’s syndrome should be “aggressively” targeted for early screening of cardiovascular (CV) risk factors, say researchers.

Laurence Fardet (University College London, UK) and colleagues found that individuals with iatrogenic Cushing’s syndrome who were prescribed glucocorticoids had a significantly higher incidence of CV events (including coronary heart disease, heart failure, or ischemic cerebrovascular events) than individuals prescribed glucocorticoids without iatrogenic Cushing’s syndrome, or those not prescribed glucocorticoids.

Indeed, Cushing’s syndrome patients prescribed glucocorticoids had a CV incidence rate per 100 person-years at risk of 15.1 compared with 6.4 and 4.1 in those without Cushing’s but who were prescribed glucocorticoids and those not prescribed glucocorticoids, respectively.

Multivariate analysis revealed that iatrogenic Cushing’s patients had a 2.27-fold increased risk for coronary heart disease, a 3.77-fold increased risk for heart failure, and a 2.23-fold increased risk for ischemic cerebrovascular events.’

Proving a medical hypothesis is never that simple. However, if you believe that CVD is due to inflammation, then the world’s most potent anti-inflammatory agents ought to decrease CVD risk. Instead, it increases it by at least 400%. [Far more in some studies]

Other anti-inflammatory agents, known as Non-steroidal anti-inflammatories (NSAIDs) also greatly increase the risk of CVD. Vioxx (a potent NSAID), launched then pulled off the market, was estimated to have killed over one hundred thousand people in the US alone, from increasing CV risk.

In short, if CVD is primarily a disease of inflammation, then potent anti-inflammatory agents ought to reduce the risk. Instead they increase it massively. There is no doubt that inflammation is associated with CVD. Equally, if you measure C-reactive protein (a marker of inflammation), a high level is associated with a higher risk of CVD. However, it is not a cause, and if you try to reduce inflammation you will almost certainly increase the risk of CVD, not decrease it.

Ergo. Inflammation is sign of active CVD. That is all.

Lowering cholesterol – an urgent Christmas appeal

A reader of this blog sent me this e-mail message that she had just received:

This is a special Cholesterol e-News Bulletin asking for your help to draw your urgent attention to a recent decision by NICE that is of great concern to us.

There has been significant progress in the management and treatment of cardiovascular disease (CVD) over the past two decades, which has resulted in an overall decline in CVD deaths in the UK. Heart disease still remains one of the UK’s biggest killers. Over half of all UK adults have raised cholesterol increasing their risk of cardiovascular disease; leading to heart attacks and strokes. Not only does it have a devastating impact on patients and their families, but it also places significant burden on our health service and wider economy.

Innovative new medicines, such as PCSK9 inhibitors, are an exciting development in the treatment of cholesterol, with little known side effects and very good scientific evidence that they work to significantly reduce the levels of bad cholesterol in those at high risk of CVD.

NICE reviewed the first of these PCSK9 medicines and recommended that it should not be available for NHS patients.

HEART UK is concerned by NICE’s recent decision to turn down the use of the first of the PCSK9 medicines. This means patients will not have access to the best possible treatment options to help lower the levels of bad cholesterol, particularly those at high risk such as people with an inherited high cholesterol condition called Familial Hypercholesterolaemia.

NICE are conducting a second round of consultation, closing on Tuesday 8th December, before issuing final guidance. On behalf of the patients in England adversely affected by this decision, please join HEART UK’s efforts to reverse this decision and allow PCSK9 inhibitors to be more freely available for NHS patients.”

NICE = The National institute for Care and Health Excellence. Let us not dwell for too long upon that self-aggrandizing title. NICE was set up in the UK, initially to look at whether or not various healthcare interventions represented good value for money, or poor value for money.

For reasons beyond the understanding of man, they plucked a figure from the sky one day (well not a figure, a range) from £20 – £30K ($33 – $48K) per year. If the intervention cost more than £20 – £30K/year to provide one added year of full quality life, then they turned it down. [One year of full quality life = 1 QALY (quality adjusted life year)]. And breathe.

Of course, NICE make all sorts of exceptions (all cancer drugs get funded no matter how much they cost, or how useless they are – go figure) and the way NICE words out how much interventions actually cost/ per QALY is complete nonsense in many cases. Be that as it may, they do make an effort to say ‘How much!’ ‘You must be joking,’ Reject…bong!

If NICE do say, reject, bong! This basically means that the drug will not be prescribed to anyone in the UK. In addition, such is the influence of NICE that many other countries use their decisions as an important guide for what they will do with regard to funding. So if NICE turn a drug down, this is very bad news from the manufactures or said drugs.

Now, when it comes to the new cholesterol lowering agents (PSCK-9 inhibitors) the manufacturers have a problem. Which is that they cost around £4 – £8K ($6.4 – $12.8) per year, per patient. Now, at those sort of costs, you are going to have to have some seriously impressive benefits. At present, however, the manufacturers have no data on mortality, or morbidity. Which makes the current cost per QALY = infinity. Just slightly above the NICE thresholds.

For those who read my blog you will know that I wrote the following in ‘Changing the definition of Familial Hypercholesterolaemia.’

At present I would think that the response of NICE (to PCSK-9 inhibitors) would be ‘Are you out of your tiny little minds. Why the [[…] insert swear work of choice here], would we fund this?’ At least I would certainly hope this would be their response. Imagine if everyone on statins in the UK, around seven million, changed to PCSK9 inhibitors This would cost £56 billion pounds [$80Bn] a year. A tidy little sum. Half of the entire NHS budget.

As it turns out NICE did turn down the first PCSK9-inhbitor, no surprise there. And this is where HEART UK comes in….

Before going any further I should state that there are, currently, two PCSK9-Inhibtors launched/launching. They are Repatha ‘evolocumab’ made by Amgen. And Praluent ‘alirocumab’ to be co-marketed by Sanofi and Regeneron. They are, to all intents and purposes, identical drugs doing identical things. Remember the names Amgen and Sanofi. Amgen and Sanofi….

Now HEART UK states that it is a charity. HEART UK – The Cholesterol Charity – campaigns to increase general public and policy makers’ awareness of raised cholesterol as a major public health concern. We campaign to keep action on cholesterol at the forefront of the health debate.’ 1

Where do HEART UK get their funding from. Difficult to tell precisely. They claim to get money from public donation… how much? It’s a secret. What I do know is that they receive a very large amount of funding from companies that have cholesterol lowering products. So, for example Nestle, who make Shredded Wheat, pay HEART UK money, and HEART UK says stuff like

‘HEART UK dietician Linda Main said: “Shredded Wheat and Shredded Wheat Bitesize are low in saturated fat and can play an important role in a heart healthy diet and HEART UK is delighted that these products are supporting National Cholesterol Month and the Great Cholesterol Challenge.’2


Of course, when it comes to cholesterol lowering PCSK9-Inhibitors are the big daddies, with the big, big, budgets. So, you would expect that Amgen and Sanofi would be very, very, close to HEART UK. Well, if you expected that, you would be right. If you want to visit the HEART UK website, and look at the sponsors of their conference we have3:

Sanofi:                     Exclusive conference sponsor

Amgen:                   Sponsored symposia 1

Sanofi:                    Sponsored symposia 2

Amgen:                   Privileged sponsor…etc.

And now, to bring the two strands of this little tale together. NICE have just turned down the first PCSK9-inhbitor and so we have HEART UK reaching out to everyone that they know, or have contact with, to plead with them to sign a petition ‘On behalf of the patients in England adversely affected by this decision, please join HEART UK’s efforts to reverse this decision and allow PCSK9 inhibitors to be more freely available for NHS patients.’ Sob. But what about Tiny Tim?

Some people, were they to be truly cynical, would allege that HEART UK may not be trying to get NICE to reverse their decision on PCSK9 – inhibitors, for the great good of humankind. But because they are being paid large sums of money by the manufacturers of PCSK9-inhbitors. Shame on anyone for thinking such a thing. With Christmas coming this should be a time of peace and happiness. Such cynicism has no place in my thoughts. No sirree.

[And for my Christmas quiz the reader with the best answer to the following question will have it published on my blog. ‘What is a health charity, and should they be allowed to accept sponsorship from pharmaceutical companies?’]




The longest journey

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

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

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

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

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

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

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

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

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

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

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

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

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

Wolves: ‘Yes, we promise.

Shepherd: ‘Good.’

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

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

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

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

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

Study 329 – where the hell is the outrage?

To quote from the BMJ ‘No correction, no retraction, no apology, no comment…’

Study 329 was started in 1994 by Smith Kline Beecham, which shortly become part of the larger conglomerate Glaxo Smith Kline (GSK). Study 329 looked at the use of paroxetine, an anti-depressant, in adolescents with depression.

Following this study paroxetine was promoted and marketed heavily by GSK as demonstrating, in the words of GKS marketing materials: ‘REMARKABLE Efficacy and safety’. Over two million prescriptions were then written for children and adolescents in the US.

However, in 2002 the FDA considered study 329 to be a ‘failed trial.’ In 2003 the UK recommended that paroxetine should not be used in children and adolescents with depression because it increased the risk of self-harm and potentially suicidal behaviour.

In 2004 the FDA placed a black box warning on all antidepressants in adolescents and children stating that they increased the risk of suicidal thinking and suicidal behaviour in these groups. In 2012 GSK finally agreed to pay £2Bn for fraudulently promoting paroxetine.

But the story does not end here. A group of researchers, who had been heavily critical of this trial, finally managed to get hold of the raw data and carried out a re-analysis under the restoring invisible and abandoned trials (RIAT) initiative. Yes, this saga has been a long one.

The reanalysis was recently published in the BMJ with sadly predictable results. The primary conclusion was that ‘Neither paroxetine nor high dose imipramine showed efficacy for major depression in adolescents, and there was increase in harms in both groups.’

This is in stark contrast to the original trial results. When it was first published it appeared to demonstrate very clearly that paroxetine was both safe and effective in adolescents with depression. According to GSK it demonstrated ‘.remarkable efficacy and safety’ However, using exactly the same trial data, reanalysed by independent researchers, we now find that paroxetine was both useless and damaging.

So, what has been the consequences for those involved in the initial trial and the writing up thereof? For those who read the BMJ, you will know that I am now quoting verbatim here:

  • Despite subsequent FDA and MHRA warning about increased risks of suicidal thinking and behaviour and GSK receiving a record fine, partly for illegal off-label promotion of the drug, the original report has not been retracted or even had a correction
  • Academic and professional institutions have failed to publically address the many allegations of wrongdoing
  • None of the named authors had intervened to correct the record. An internal enquiry by the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) concluded that no further action was necessary
  • Brown University remains silent over its involvement in the study. It refuses even to confirm or deny whether any investigation took place1

I will add to this that a co-author of study 329, Karen Wagner, named eight times in the 2011 US Department of Justice complaint against GSK, is currently the president elect of the American Academy of Child and Adolescent Psychiatry – whose journal, the JAACAP, is where the original study was published.

Taking stock. What do we have? A study was done, and published, demonstrating that paroxetine was safe and effective. The trial data were heavily promoted, resulting in millions of children and adolescents being prescribed paroxetine.

The reality is that this drug was completely ineffective and increased the risk of suicide (amongst other things). This has all been known for many years. The latest re-analysis simply confirms everyone’s worst fears.

So surely someone, somewhere, got punished? No they did not. Not only that, but the original published study has not even been retracted. It still sits in the medical database. A young and innocent researcher could come across it, and reference it, and use data from it to support a grant application for a study to use antidepressants in children.

If this were not all completely and absolutely one hundred per-cent fact, you might think we have a possible plot line for a dystopian novel here. A story of terrible corruption where large corporations can distort data through one hundred and eighty degrees, and get away with a fine. A world where bent researchers promote research that results in more children committing suicide, and then move on positions of greater power and authority – with no censure from anyone. To become presidents of major medical societies, for example.

Frankly I don’t think I would dare to write a novel with a plot so completely outrageous. Surely someone, somewhere, would be punished for this behaviour. Surely the paper would be retracted. Surely a co-author of such a study would not be in line for a prestigious position. Surely the public would rise up in outrage.

In truth, it seems, nothing is going to happen at all. I must dig out 1984 and read it again, just to depress myself even further.

1: BMJ 2015;351:h4629

The Augean Stables – part II

It has become clear that much of medical research is flawed, and so inherently biased that much of it/most of it simply cannot be relied upon. One of the strongest critics of this current situation is a brilliant statistician, Professor John P Ionnadis. His seminal paper on the subject of medical research, which is nearly ten years old now, was entitled ‘Why Most Published Research Findings Are False ‘. I include the abstract here:

‘There is increasing concern that most current published research findings are false. The probability that a research claim is true may depend on study power and bias, the number of other studies on the same question, and, importantly, the ratio of true to no relationships among the relationships probed in each scientific field. In this framework, a research finding is less likely to be true when the studies conducted in a field are smaller; when effect sizes are smaller; when there is a greater number and lesser preselection of tested relationships; where there is greater flexibility in designs, definitions, outcomes, and analytical modes; when there is greater financial and other interest and prejudice; and when more teams are involved in a scientific field in chase of statistical significance. Simulations show that for most study designs and settings, it is more likely for a research claim to be false than true. Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias1.’

Has his work been contradicted by anyone? The answer would be a resounding… no. In fact, all that has happened over the last ten years is more and more confirmation that medical research has become worse.

This is an incredibly worrying situation, yet very few people seem in the slightest bothered. The status quo remains in status. When new medical studies come out the press continue to regurgitate the findings as though they are unquestioned gospel. Experts have maintained their status as demi-gods, to be fawned upon as though their work is beyond any possible reproach.

Guidelines, the ones that instruct doctors on how to treat various conditions, are still published without any provisos. Guidelines which are based on evidence that… ‘may often be simply accurate measures of the prevailing bias.’ But woe betide any doctor that fails to follow said guidelines, for they may well be struck off the medical register. In the US, you could end up in jail.

All of these things are bad enough, and there are many other problems. However, in this blog, I want to focus on another issue. Namely, what about placebo controlled studies? Just to make it clear, for those who know a great deal about this area, I am not looking at the issue of ‘what the hell is in placebos anyway, cos it sure as hell ain’t inert substances.’ Whilst the fact that you cannot find out what manufacturers actually put in placebos, which should be inert ‘sugar pills’, but most certainly are not, is extremely important, that is an issue for another day.

Today’s issue is as follows. We have reached a situation in medical research where it may never be possible to find out if certain treatments actually work. Sub-header… ‘And in which case we are all doomed.

Here is the context. Once a treatment has been found to be superior to a placebo, it will be deemed unethical ever to carry out a placebo controlled study ever again. That may not mean much to many people, so I shall expand – using a concrete example (yes, statins again).

If placebo controlled studies have shown that statins reduce the risk of heart disease, and for the sake of argument let us accept that this is true, where does this leave us? It leaves us in the position whereby, if anyone wanted to set up a study to try and disprove that statins are no better than placebo, they will never be given permission to do so.

Why not? Well, before you are allowed to carry out a clinical study, you have to present it to an ethics committee. This committee will look at the proposal and decide if it is indeed ‘ethical.’ Exactly what this means is up for debate. However, if you decided to study the speed at which cars need to run into children, to result in a fifty per cent mortality rate, I imagine you would be turned down by the ethics committee.

More prosaically, if you have found that statins reduce the risk of dying of heart disease vs placebo, then you will no longer be allowed to do a placebo controlled statin trial ever again. The reason for this is that you have already ‘proved’ that statins are superior to placebo. So it will argued that any volunteer placed in the placebo arm of your study would be suffering avoidable harm. Bong! Ethics committee says no. We know statins work, so it is unethical not to give them.

The only studies the ethics committees will allow would be statins vs. statins and a new drug. Equally you would not be allowed to study a new drug vs. placebo, at least not for an indication where statins had shown a benefit. Because everyone ‘at risk’ should be on a statin already.

Now, I have some sympathy for pharmaceutical companies in this situation. If statins reduced the risk of heart disease by 50% (made up figure), then any new drug can only provide an incremental benefit over statins – there is only 50% possible benefit left. So you need to study more people, over a longer period, to demonstrate superiority over statins. A higher hurdle than statins had to get over to be approved.

In another way, obviously, I have less sympathy. Let us suggest that all of the statin trials were biased. Let us further suggest that statins do not have any benefit over placebo. Is there any evidence for this? Well, the only major non pharmaceutical funded study on statins vs placebo was ALLHAT-LLP. Which was run by the National Institutes for Health (NIH). It was reported thus:

‘Washington, DC – Surprising results of an unblinded but randomized comparison of pravastatin (Pravachol® – Bristol-Myers Squibb) vs “usual care” in patients with hypertension and moderate hypercholesterolemia enrolled in the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT) show that pravastatin did not significantly reduce either all-cause mortality or fatal or nonfatal coronary heart disease (CHD) in these patients.’

So, no benefit at all. This study was immediately attacked by all the ‘experts’ and dismissed as being useless, not enough LDL lowering, not enough difference from standard care blah, blah. Nothing to see here, move along.

However, I find it interesting that the only statin study which was not funded by the pharmaceutical industry was completely negative. You may even believe that this would give people pause for thought. If so, silly you.

Where does this leave us though? Well, as already stated, you can never, ever, do another statin vs placebo study. For it would be unethical to do so. You can never do a cholesterol lowering study on any other drug vs placebo either, for it would be unethical to do so. If the statin trials were all correct and unbiased and without the slightest doubt attached to them….fine. If, however, these trials were simply accurate measures of the prevailing bias then we are completely screwed.

This leaves us in a situation whereby if we test other drugs against statins, we are testing a drug against a drug that we cannot be certain has any benefits at all. So, what can we prove? Nothing. Which means that the very foundations of all future research in this area have been built on a bog.

So, what can we do? Carry on believing that all the research done is correct and above any suspicion of bias and manipulation. If so, fine, but you may have trouble sleeping at night. If not, you are going to have to tear apart all of the research that has been done, and do it again. I think that makes the task of Hercules look pretty easy.



The Augean stables

For many years it was possible to start a clinical trial, on a drug, without telling anyone that you were doing so. Then, if it turned out to be negative you could just slip it under the carpet and never let anyone know you were doing it. This is what happened with many antidepressant trials. Positive, publish. Negative, bury. Unsurprisingly, the results for antidepressant treatment looked pretty damned good.

Another little trick was to keep the primary end-point of the trial secret. To explain. Say you started a study on statins where you most wanted to look at the effect on overall mortality – whether taking statins meant more people were alive at the end of the study, than those taking a placebo. In this case overall mortality would be the ‘primary end-point’.

You could also measure other outcomes, or end-points. For example, you see how many people were admitted to hospital with angina, or how many people needed an angiogram and/or stent. Or how many people suffered a non-fatal heart attack or stroke. You can, in fact, measure many different things. These would usually be called secondary end-points.

Up until fairly recently, if you failed to reach your primary end-point – the term normally used for this sorry state of affairs would be ‘failed to reach statistical significance’ – you didn’t need to let anyone know. You could just say. ‘Oh look, the number of episodes of angina was significantly reduced, as was hospitalisation for chest pain and the rate of non-fatal strokes.’ Success!

Man on Clapham omnibus:          ‘But, but, I thought you said the trial was going to look at overall mortality.’

Pharmaceutical company:           ‘How do you know that, we never told anyone what the primary end-point would be.’

Yes, I know, pharmaceutical companies cannot speak. But you get the general idea.

Now, if you start trawling around your data, you can almost always find something somewhere got better. And if something else got worse, you can just fail to mention it. Essentially, therefore, unregistered clinical trials are not worth the paper that they are written on. Especially, of course, if they never got written on any paper at all.

In the year 2000 the major US group the National Heart, Lung, and Blood Institute (NHLBI) decided that any studies they were going to fund (these are non pharma company studies) must register all end-point/primary outcomes, before the study started. This means that the trial investigators could not manipulate the results post-hoc.

A group of researchers recently looked at 55 large clinical studies funded by the NHLBI between 1970 and 2012 to see if the transparency rules had made any difference. What they found should shake the foundations of medical research…but it almost certainly won’t:

  • 57% of studies (17/30) published before 2000 showed a significant benefit in the primary outcome
  • 8% (2/25 trials published after 2000 showed a significant benefit in the primary outcome

As the researchers said ‘The requirement of prospective registration in is most strongly associated with the trend towards null clinical trials. The prospective declaration of the primary outcome variable required when registering trials may eliminate the possibility of researchers choosing to report on other measures included in a study. Almost half of the trials [published after 2000] might have been able to report a positive result if they had not declared a primary outcome in advance.1

Pharmaceutical companies have been asked to register trials since 2005.

At this point I am going to try and join two thoughts together. Almost every study done on blood pressure lowering, blood sugar lowering and cholesterol lowering was done before the year 2005. I only choose these three areas as they are the three area of maximum drug prescribing in the world. Billions upon billions are spent in these areas, hundreds of millions are ‘treated’.

The evidence used for this mass medication of the Western World is demonstrably, horribly, biased. Had companies been forced to register their trials prior to publication, positive results would have been reduced by at least 49%. Almost certainly far more. You could put this another way around and say that it very likely that only 8% of studies would have been positive.

We do not know which trials would have been positive, or which negative. Yet we have based the entire edifice of drug treatment, of hundreds of millions of people, on unreliable nonsense. The study in PLOS is only the latest demonstration of this fact. The database of medical research – everything until at least 2005 is a gigantic festering mess. It needs to be stripped out and cleansed.

Do you think this is too strong?

Well I shall now quote Dr Marcia Angell, Dr Richard Horton and Dr Richard Smith. Editors of, respectively, the New England Journal of Medicine, the Lancet and the British Medical Journal. The three highest impact factor journals in medical research.

It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgement 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 editor of the New England Journal of Medicine.’ Marcia Angell.

‘The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness.’ Richard Horton

‘The poor quality of medical research is widely acknowledged, yet disturbingly the leaders of the medical profession seen only minimally concerned about the problems and make no apparent efforts to find a solution.’ Richard Smith

Who, in a position of power, will finally wake up and realise that the vast database of medical research stinks of bias and manipulation. Who can we call upon to take up the gigantic and painful task of clearing out the Augean stables?


Conflict of interest – not just about money

There is a major spat going on at present around Conflict of Interest. The New England Journal of Medicine (NEJM) appears to be backtracking on the issue, and they are talking about relaxing their rules. The British Medical Journal (BMJ) is very ‘heavy’ on Conflict of Interest (COI) and has been somewhat critical of the NEJM approach – to say the least. See 13th June edition of BMJ.

To give you a flavour, one article in the BMJ has the title ‘Backtracking on conflicts of interest: a very bad idea… A series of articles in the New England Journal of Medicine has questioned whether the conflict of interest movement has gone too far in its campaign to stop the drug industry influencing the medical profession. Here three former NEJM editors respond with dismay.’

My sympathies are almost entirely with the three former editors: Robert Steinbrook, Jerome Kassirer and Marcia Angell. I think bias, and resultant distortion of medical research is a massive problem. So massive that it has become difficult to believe most of the research that is published. I am not alone in my concerns. Here is what Richard Horton (Editor of the Lancet), has to say on the matter:

‘The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness.’

A half of medical scientific research may be untrue… think on the implications of that for a moment. However, before you focus all your efforts on trying to expose financial conflicts of interest as the solution to all problems, you need to take several steps back. Here are just two of the elephants in the room:

  • Just because someone is getting paid, does not mean they are saying or doing anything that is biased, or distorted. So, by introducing punitive rules on payment from the industry, you could be punishing everyone who has ever received any money, when many of them have done nothing wrong.
  • It is incredibly simple to set up structures that allow money to be paid to a ‘charity’, or a University Department, that can then be filtered down to an opinion leader who can then state, quite truthfully, that they receive no money from the industry. So, if you are going to look for conflicts, you are going to have a dig considerably deeper than looking for a direct transfer of money from pharmaceutical company to doctor. And that is tricky to enforce.

There is also another major issue here, which no-one seems to have discussed at all. Which is that money is most definitely not the only currency available when it comes to ‘bribes.’

At present, COI is seen in very simple terms. A conflict of interest is that someone (usually an international expert in, say, psychiatry) is paid lots of money by a pharmaceutical company. They then say exactly what the pharmaceutical company has written down on a piece of paper for them to say e.g. ‘This new product depressagon is completely safe, highly effective, has no side-effects, and I believe that depressagon should be use, first line, in anyone with depression. Thank you, where’s my cheque.’ The last three words are usually silent.

The International expert then sits on a guidelines committee for depression, and encourages all the other members of the panel to put depressagon on the list of first line drugs to be used in depression – and any other mental illnesses they can think of. At which point the Acme Pharmaceutical Company Inc. makes twenty billion dollars a year from depressagon. Which means that the one hundred million paid to the offshore account of said expert can be considered money well spent.

Of course, it is never as crude as this. Paying people money to say what you want them to say is considerably more subtle and nuanced. A raised eyebrow here, a small cough in the correct place there, an embarrassed silence round the table… the rules of playing the game are complex and never written down anywhere. In fact, if you have to ask how to take part, you don’t get invited.

However, urbane, crude, or not, there is still an assumption that the currency of COI is money, specifically money that ends up the experts bank account (directly, or indirectly). This is nonsense. There are many other things on offer. The most important of which is…power.

If you can work with the industry to attract several hundred million to your University for research; if you can be the lead investigator in several major international studies, then you will gain prestige, influence and power. The University may create an entire department as your plaything. You can have fifty new staff members, you will be asked to sit on prestigious committees. You can advise Governments on health policy.

Money….money. Who needs that? To quote Kevin Spacey playing Francis Underwood in House of Cards:

‘Such a waste of talent. He choses money over power. In this town, a mistake nearly everyone makes. 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.’

Up to now, all discussions about Conflict of Interest have focussed purely on payment in money. As if this is the only reason why someone may, ever, be influenced. When a medical expert states proudly they are not paid by pharmaceutical companies this may or may not be true. Tracking the flow of money into and out of Universities and medical charities is a complex old game.

However, no-one seems to have grasped a very important concept. You don’t have to pay someone money to manipulate them. They can be rewarded, instead, with power and influence. Conflict of Interest is about far more than money, and we should stop pretending otherwise.

You’re killing my patients (again)

Some of you may remember that the Australian Broadcasting Corporation (ABC) ran two programs in 2013 about saturated fat and statins. The messages were that saturated fat does not cause heart disease, and statins have more side effects than were reported in the trials, and could do more harm than good in patients at low risk of heart disease.

Massive outrage ensued, at least in Australia, a faraway country of which we know little. However, the battle is important for us all. For it is about crushing free speech and stomping on any criticism of medical ‘experts.’ Which is a very dangerous thing indeed.

After internal investigation, ABC pulled both programs and apologized profusely. Even though they could find nothing wrong with the programme on saturated fat, and only one of seventeen objections was upheld. And this objection was, in my opinion, a relatively minor issue (see a previous blog on the matter).

Just to refresh your memory. Here is the only point in which the programs were felt to have misrepresented the facts, followed by my comment at the time.

‘The program’s treatment of use of statins in secondary prevention focused solely on mortality benefits in a way that reinforced the view that statins were overprescribed and their benefits exaggerated. The principal relevant perspective that statins have wider benefits for this group was not properly presented. This perspective was necessary to a fair understanding of the pros and cons of statin use in this group.’

My Comment: [Turning this into English. What the committee believe they found was that the second Catalyst program ‘Cholesterol drug war’ did not mention that statins have benefits on non-fatal outcomes e.g. non-fatal heart attack, and non-fatal stroke. By failing to emphasize this point it was judged that the program gave a misleading perspective on the overall benefits of statins (in secondary prevention).]

However, all of this was represented as follows:

ABC takes down Catalyst heart disease episodes after review criticism Controversial TV program on cholesterol-lowering statins found to have breached editorial standards.

‘Two episodes of the TV science program Catalyst will be removed from the ABC’s website after an internal review found the program had breached editorial standards on impartiality.

The controversial Catalyst program on statins and heart disease, The Heart of the Matter, was attacked by health experts even before it aired last year.

The presenter of ABC radio’s Health Report, Norman Swan, warned “people will die” as a result of the TV program’s messages about heart medications.

Swan, whose criticism of the program has been vindicated by the independent Audience and Consumer Affairs Unit report, had said the program made him “really angry” because it might affect Indigenous Australians, who are especially likely to suffer from high cholesterol.’ {P.S. Norman, indigenous Australians have lower cholesterol levels than the surrounding population}.

If this was all you had heard about the matter you would assume that ABC had done a very shoddy job, with sloppy and potentially dangerous reporting. Yet all of this ‘howling villagers with pitchforks’ attack was based on a single issue. It should be emphasised that, at no point did the programs suggest that anyone should stop taking a statin, or that statins should not be used in high risk patients.

But the vicious attacks did not stop here, oh no. Now we have a paper in the Medical Journal of Australia, reported yesterday, as follows:

Today, researchers from the University of Sydney and the Australian National University report on the impact of another Catalyst program. In October 2013, Catalyst broadcast a segment highly critical of statins, a class of drug used for lowering cholesterol.

The program questioned the link between cholesterol and heart disease, and suggested the benefit of statins in preventing cardiovascular disease was exaggerated.

There was extensive criticism of the program, including from the ABC’s own Norman Swan and the ABC later removed the episodes from the Catalyst website after an internal review found that the episodes had breached its impartiality standards.

The new report in the Medical Journal of Australia used Pharmaceutical Benefits Scheme data of 191,000 people and found an immediate fall of some half a million fewer statins dispensed to patients in the eight months following the Catalyst broadcasts.

The authors wrote:

This translated to an estimated 60,897 fewer people taking statins over the eight months examined. If patients continue to avoid statins over the next five years, this could result in between 1,522 and 2,900 preventable, and potentially fatal, heart attacks and strokes.

One of the study authors, Associate Professor Sallie Pearson, Scientific Director of the Centre of Research Excellence in Medicines and Ageing at the University of Sydney, said:

What is particularly concerning is that this drop in use was seen in people who were at high risk of cardiovascular disease – for example, those who were also taking medications for diabetes. Heart attacks and strokes are the main killers of people with diabetes.

Statins are recommended for people at high risk of cardiovascular disease because they have been shown to be effective. Like all medications, they have risks and benefits and should only be used as recommended.

The study authors wrote:

Even though the observed effect was relatively small, the prevalence of statin use in Australia and their established efficacy means that a large number of people are affected, and may suffer unnecessary consequences.

Why would anyone have done such a study? The only possible reason is that it was a deliberate effort to destroy any possibility of anyone ever criticising statins again? The whole thing is appalling and disgraceful.

At no point (to restate this yet again,) did the programs suggest people at high risk (secondary prevention) of heart disease stop taking statins. Yet, as you can see, the main attacked focussed on the fact that there was a reduction in people taking statin, in those at high risk of heart disease. What nonsense. Yesterday I wrote the following in a comment on an Australian website ‘The Conversation.’1

Here is the kind of delicious irony we should all enjoy. To quote Sallie Pearson, one of the study authors. ‘What is particularly concerning is that this drop in use was seen in people who were at high risk of cardiovascular disease – for example, those who were also taking medications for diabetes.’

Oh my God, people with diabetes are giving up statins. Well, as statins increase the risk of diabetes by 46%* then it would not be surprising to find a significant number of people with diabetes giving up statins. After all, it would have been, in many cases, the statins that gave them the diabetes in the first place. So, giving up the statins would probably have ‘cured’ their diabetes. And as we all know, to quote Sallie Pearson again…’Heart attacks and strokes are the main killers of people with diabetes.’ Yes, indeed.

Pursue this line of argument for too long and madness shall surely follow.

*The use of statin treatment could increase risk of type 2 diabetes by 46%, as a result of decreases in insulin sensitivity and insulin secretion, according to researchers from the Institute of Clinical Medicine in University of Eastern Finland.

P.S. When it comes to statins, 75% stop taking them in the first year anyway. So the Catalyst programme would have been but a drop in a very large ocean.

P.P.S. As you will see, most people stop taking statins due to adverse drug effects which, according to the programmes critics, do not really exist.