Cholesterol Games

3rd March 2019

Mahatma Gandhi. 

I was advised that the Mail on Sunday was gong to attack us for daring to question the cholesterol hypothesis as well as the benefits of statins.

Below is the email I received.

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 along with numerous other people have publicly made about statins, the use of cholesterol in cardiovascular disease, and the allegations that investigators to the medication are financially conflicted because of payments made to the organisations they work for, and thus the evidence they supply about the efficacy of these drugs, 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 make definitive proof the pills lower heart attack risk by around 50 percent, and a stroke by 30 per cent, and reduce the possibility of death — from any cause.

In January, the editors-in-chief of 30 significant heart health medical journals — each a leading cardiologist — signed a joint open letter, warning:’Lives are at stake [because of the] wanton spread of health 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 could have prompted 200,000 patients in Britain alone to give up the drug over a single six-month interval following an article you wrote for the BMJ that claimed, erroneously, 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 consequence 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 scammed. The best way to prevent 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 might imply that those who assert that lowering cholesterol can help lower the risk of heart disease know that this is untrue and are deliberately misleading the public.

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

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

*You often quote observational studies as evidence of your claims about statins and cholesterol in posts and in media appearances which contradict findings of definitive clinical trials, which you don’t mention. This is misleading.

They will not allow anyone else see the information they hold. Including all of the data on side-effects. It is kept completely confidential.’ Also:’A fact that must be emphasised is that the CTT won’t let anyone else see the data they hold. Including all the data on adverse events [side-effects] and serious adverse events.’ It’s a version of similar claims you’ve made a lot of times through the years. However, the CTT have said numerous times that they did not originally request the information on all adverse events so did not have it. They also point out that the stated data must be requested from the individual research organisation which carries out the trials, and is not in their present to provide. They say you understand this, as they’ve told you this, so to repeat the claim amounts to a lie.

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

*There is not any proof you work in NHS clinic, or as a GP in private practice.

Many thanks,

_________________

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

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

They were 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 give up the drug over a single six-month period following an article you wrote for the BMJ which claimed, incorrectly, that 20 percent of statins patients stopped the medication due to side effects.

Frankly, I wish I had written that paper, but I did not. It was written by Aseem Malhotra. This, I hope, gives you some idea of the high level of fact checking going on at the Daily Mail. Surprisingly, there were hardly any swear words.

Dear Barney Calman,

Thank you for your email. I am not entirely certain how you would like me to respond to each of your points.

To begin with, I do work for the NHS as a GP, and if anyone wishes to claim that I don’t — then that would be direct libel. Feel free to check with trust, or look me up on the GMC website. But if anyone states that I’m not working in the NHS then I shall most certainly sue. And I will win, so I would suggest caution on this point.

As for other specific points.

*You often quote observational studies as evidence of your claims about statins and cholesterol in posts 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 estimate are observational, or that I don’t mention the findings of clinical trials that are authoritative? Which of them is a issue, and why?

I’d add that the proof of the link between smoking and lung cancer was based on observational studies. Does this mean that smoking doesn’t cause lung cancer? Or is that not their argument. Whilst observational studies are not generally regarded as powerful as randomised clinical trials, they have worth. Equally, most epidemiologists would agree that, whilst observational studies (demonstrating association) can’t prove causality (unless the hazard ratios are extremely large ) a lack of association does disprove causation. Thus, it can be fully valid to rely on observational studies where there is not any association, or the observation is in direct contradiction to the hypothesis.

*It’s been alleged that the possible consequences of claims you’ve made about statins and cholesterol, far outweigh that of the notorious MMR vaccine scandal with a single researcher saying:’In terms of death and disability that might have been averted, this may be far worse.’

If I’m wrong, then this statement could, possibly 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 made. He attacked the BMJ for publishing an article suggesting statins can have a high incidence of adverse effects. You may wish to observe 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 the 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 have been identified. Passing was postponed between −5 and 19 times in primary prevention trials and involving −10 and 27 times in secondary prevention trials.

What this study found was that if you took a statin for five decades, the increase in life expectancy could 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 understand the absolute risk. Equally, to state lives could be saved is meaningless. No-one’s life can be saved. That’s what matters. I covered a lot of this in my novel Doctoring Data, which I’d advise that you read, as it summarizes the ways that data are presented to seem as beneficial as possible.

*In our article, one leading cardiologist says the truth you and others frequently cite about cholesterol and statins sound convincing but that in reality’that they have a grain of truth, combined with speculation and opinion, which makes is very tough for the public to know who to trust.’

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

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

Yes, I feel that people are being scammed, and I think the public are being deliberately misled. That’s the reason I called my first publication The Great Cholesterol Con. I’d point out that there was one major placebo controlled double blind statin study done. ALLHAT-LLT, which was financed by the National Institutes of Health in the US. The conclusions of the study, published in 2002, were that:

CONCLUSIONS:

Pravastatin didn’t 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 the industry funded studies were positive. This is a remarkable coincidence — or something else.

They will not allow anyone else see the information they hold. Including all of the data on side-effects. It is kept completely secret.’ Also:’A fact that needs to be emphasised is that the CTT will not allow 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 comparable claims you’ve made numerous times over the years. However, the CTT have stated many times that they didn’t initially request the information on all adverse events so did not have it. They also point out that the said data have to be requested in the individual research organisation that carries out the trials, and is not in their present to provide. They say you know this, since they have told you this, so to replicate the claim amounts to a lie.

You could perhaps ask them to point you to some letter or any other form of communication that the CTT have had with me. I will inform you the answer, they have never communicated directly with me, at any time. Thus, for them to state they’ve told me anything is, to be fully accurate, a lie. They claim don’t hold the information, yet they’ve managed to publish major newspapers on statin adverse effects? For instance, this one. Interpretation of the evidence for its efficacy and safety of statin treatment .

Which contains sections such as these

‘The only serious adverse events which have been shown to be brought on by long-term statin treatment –i.e., adverse effects of the statin–are myopathy (defined as muscle pain or weakness along with large increases in blood levels 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 treatment 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 consideration 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 five years.’

So, they’ve 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 handle that?

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

Maybe you would like to read this paper (that I co-authored)’LDL-C doesn’t cause cardiovascular disease: a comprehensive review of the current literature.’ Https://www.tandfonline.com/doi/pdf/10.1080/17512433.2018.1519391?needAccess=true  that was THE most downloaded paper published by Taylor and Francis in the previous 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.’ Released 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, especially 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 offers 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 part of cardiovascular disease prevention strategies.

All I see from your e-mail are ad-hominem strikes on me. I see no facts at all. 

Yours Truly

Dr.Malcolm Kendrick

I followed up with a section of this battle that Prof Sir Rory Collins had Fiona Godlee within the book of the Aseem Malhotra newspaper 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 interval following an article you wrote for the BMJ that claimed, erroneously, that 20 percent of statins patients quit the medication because of side effects.

I didn’t write that report. It is advisable to check your facts a little more closely before placing 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 approximately 20 percent of individuals. Collins strikes were acute, and the BMJ was require to hold an investigation, where Collins strikes on these papers were judged to be unfounded. The whole 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 always concerned the panel. Prasad compared two meta-analyses of statins in primary prevention that differed in their statistical decisions by less than half a percentage point and reached opposite conclusions–namely that that”statins decrease… total mortality” or conversely that”data. . . Showed no decrease in mortality associated with therapy 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’ research has a robust set of de-identified individual-patient data, which can enhance our understanding, and those data should be made widely available.

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

The panel was unanimous in its decision that the two articles don’t meet any of the standards 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 in the range of reasonable opinion among those who are debating the appropriate use of statins. In making this assessment, the panel isn’t expressing an opinion regarding the merits of these arguments, as that work was beyond the scope of the panel.

The panel did have one last comment. It became clear to the panel that the fact that the trial data upon which this controversy is based are held by the researchers and not available for independent assessment by others might contribute to a number of the uncertainty about risks and benefits. Different investigators may come to different conclusions with the very same data. In actuality, a particularly germane example occurred recently in both experienced Cochrane groups were charged with evaluating a particular intervention and, despite being given the same instructions, data, and resources, didn’t arrive in identical results or decisions. The panel strongly believes that the current debates on the appropriate use of statins would be raised and usefully informed by making accessible 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 physician — which is a truth.

In other words, the attacks on Aseem Malhotra were completely unfounded, as were the attacks on the BMJ. The whole dilemma 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 to not have?

How can it be allowed that one group of investigators hold all the information 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 anybody else?

Anyway, this is probably enough for today. I just wanted to give you some idea of the strikes 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 images of me Zoe and Aseem in the front. I think I look quite dashing. Not as dashing as Aseem who is a really handsome swine, and also young, and smart — and courageous.

Nor am I as attractive as Zoe Harcombe. 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 things that I sent.

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

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