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
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.’
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.
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…
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.
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.
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 https://journals.bmj.com/sites/default/files/BMJ/statins/SP13_Emails_between_Rory_Collins_and_Fiona_Godlee.pdf
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.
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. https://www.ncbi.nlm.nih.gov/pubmed/12479764
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. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)31357-5/fulltext
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?
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.’ https://www.tandfonline.com/doi/pdf/10.1080/17512433.2018.1519391?needAccess=true 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
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
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. https://www.bmj.com/content/bmj/349/bmj.g5176.full.pdf
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
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.