“Statin deniers are putting patients at risk, says Minister” (“the News Article”); (2) a main article, which was published in a “Health, Wealth & Holidays” section of the newspaper on pages 47-50 of the newspaper, under the headlines: “Deadly propaganda of the STATIN DENIERS”
“The Claimants aver that the publications complained of consist of defamatory statements of fact concerning them and deny that they are ‘statements of opinion’ within the meaning ofs.3(2) of the Defamation Act 2013 … The Claimants deny that the publications bear the meanings ascribed to them by the Defendants… The Defendants by their Defence downplay and seek to sanitise the true defamatory effect of what they published, which, in truth, so far as concerned the Claimants, consists of an unwarranted hatchet-job or, to use the Second Defendant’s own word, ‘takedown’… In particular, the Defendants seem to wish to shirk responsibility for accusing the Claimants entirely unjustifiably of dishonest and venally motivated conduct, and further accusing them of causing very many people, by that conduct, to be [at] a greater risk of a heart attack or a stroke… So far as the Defendants’ defences are concerned. A. The Claimants deny that any of the publications complained of is honest opinion unders.3 of the Defamation Act 2013 . It is denied that any of the conditions in s.3(2)-(4) is met in relation to any of the publications complained of. Further, if contrary to the foregoing, any of the publications complained of is found to be a statement of opinion, the Claimants will show (a) that the Second Defendant, for whose conduct in publishing the articles complained of the First Defendant is vicariously liable, did not hold any defamatory opinion about the Claimants that the publications may be found to bear; or, alternatively, (b) that the First Defendant knew or ought to have known that the Second Defendant did not hold any such opinion about the Claimants. B. The Claimants deny that any of the publications complained of is substantially true unders.2 of the Defamation Act 2013 ... C. In particular, the Claimants respond to the Defendants’ defences of honest opinion and truth by contending that an evaluation of the relevant scientific evidence relating to cholesterol, CVD and statins, primarily in the form of published scientific studies, demonstrates that the science on these issues is not in fact cut and dried as appears from both the articles complained of and the Defence (and could not reasonably be considered to be cut and dried), and that all the published statements that the Claimants have made on these topics – which are not the same as the ones that the Defendants have imputed to them in the publications – they have made honestly and reasonably on an evidence-based basis … D. The Claimants deny that statutory reporting qualified privilege unders.15 of the Defamation Act 1996 attaches to any of the passages in the publications complained of to which the Defendants contend it attaches, including by virtue of the fact that the publication of each such passage was and continues to be made by the Defendants with malice… E. The Claimants deny that peer-reviewed scientific statement privilege unders.6(5) of the Defamation Act 2013 attaches to any of the passages in the publications complained of to which the Defendants contend it attaches, including by reference to the fact that the publication of each such passage was and continues to be made by the Defendants with malice... F. The Claimants deny that the publications complained of (or any of them) is a publication on a matter of public interest unders.4 of the Defamation Act 2013 . It is denied that the Defendants believed or believed reasonably that publication of any of those publications was in the public interest…”
“(a) the Second Defendant, and through him the First Defendant, misused or abused the occasion in respect of which privilege is claimed, for a purpose other than that for which the privilege is accorded by the law, namely for the purpose of obtaining the private, professional advantages that were gained by unwarrantedly and spuriously investing his and the Mail on Sunday’s defamatory remarks concerning the claimants and Dr Malhotra with the endorsement of the Secretary of State for Health and Social Care and thereby making his story seem significantly more credible than it was and more impactful; and (b) this was the Second Defendant’s, and through him the First Defendant’s, dominant purpose in and motive for publishing these statements; and (c) the Defendants published or caused to be published the representation embodied centrally in the statements that Matt Hancock MP had himself made trenchant defamatory remarks concerning the Claimants and Dr Malhotra and/or had associated himself with and endorsed the Defendants’ own defamatory claims concerning those individuals in the articles complained of, in the knowledge (through the Second Defendant) that that representation was false and that Mr Hancock had not himself made any remarks regarding those individuals of that kind (or at all) or associated himself with or endorsed the Defendant’s defamatory claims about them; or (d) the Defendants published or caused to be published the aforesaid false representation recklessly (through the Second Defendant), not caring whether it was true or false.” (2) in respect of the extracts from the LSHTM Paper, that: “(a) the Second Defendant, and through him the First Defendant, misused or abused the occasion in respect of which privilege is claimed, for a purpose other than that for which the privilege is accorded by the law, namely for the purpose of obtaining the private, professional advantages that were to be gained by unwarrantedly and spuriously investing his and the Mail on Sunday’s defamatory claims about the Claimants and Dr Malhotra with the authority of the LSHTM, a well-known and reputable UK university college specialising in public health, and of an expert scientific study published by the LSHTM, thereby making those claims and his story seem significantly more credible than they were and more impactful; and (b) this was the Second Defendant’s, and through him the First Defendant’s dominant purpose and motive for publishing these statements; and (c) the Defendants published or caused to be published the representation embodied centrally in the statements that the LSHTM paper and its findings relate to ‘scare stories’ and ‘fake news’ about statins, specifically alleged statements made publicly by the Claimants said to match that description and Dr Malhotra’s 2013 BMJ article, in the knowledge (through the Second Defendant) that the representation was false and that the LSHTM paper and its findings, which relate only to an alleged ‘period of intense media coverage of controversy over the risk:benefit balance of statins’ following the publication of Dr Malhotra’s 2013 BMJ article, have nothing to do with the Claimants or anything that either has said or done or Dr Malhotra or anything that he has said or done including his 2013 BMJ article; or (d) the Defendants published or caused to be published the aforesaid false representation recklessly (through the Second Defendant), not caring whether it was true or false”
“During February 2019 I spoke to each of [the] experts [identified in [67] below]… on the telephone. By that time I had worked out what I believed was the thrust of the Claimants’ arguments so I framed my questions to them by reference to these arguments. I ended each conversation by asking ‘why do you think they do this?’ I also read various research papers, articles and other materials about the evidence base for statin therapy. A key document I read was The Lancet Review…”
“Aseem’s position on statins is simply that he wishes the patient to be able to make an informed choice when presented with the benefit and risks (thennt.com data)”
“I regarded Dr Kendrick, at least in respect of his media persona, as a contrarian. In many ways his contrarianism has defined his professional media identity. I accept that alongside his work in the media, he works as a GP where I believe it would be more difficult for him to be so out of step with the orthodoxy, as GPs must abide by the types of guidelines Dr Kendrick criticises (e.g. those relating to the prescription of statins to certain groups) to continue to work in the NHS”
“… [Mr Calman] he explained that there was a group of people on the internet and in newsletters and on the radio who were saying things about statins that were misleading and that this was having, you know, a bad influence in the real world... So, you know, if people are being put off taking statins, which could actually save their lives, because of misinformation, that’s a very real concern. So, in that conversation, Barney and I agreed that what we needed to do was a piece where we spoke to the – you know, the world’s best experts and presented our readers with the truth, and so the balance of the article was dictated by that, because the motivation wasn’t to do a piece saying -- you know, which we could have done – ‘Are statins good or not’; that wasn’t the motivation. The motivation was to do a very polemical, strong piece saying, ‘Statins are good for you and you shouldn’t take notice – you know, if you hear chatter or read things on the internet, you shouldn’t let that put you off taking them’. That was the point of the article, and that’s where the balance came from.”
“… the Mail on Sunday recently launched a campaign to fight fake health news. Having read your comments last week in the news, I can see this is a subject you are interested in! I wonder if we could have a chat. We really want to get behind a concerted push to highlight statins conspiracy theories for just what they are, and give readers the medical evidence and the facts…”
“Can you take a good [look] at this – we’re planning a big takedown of statin deniers. Zoe is one of them”
“… Just in case you’ve not seen, this is the sort of thing we are up against. I don’t want to turn it into a ‘he said, she said’, but this is a good example of misinterpretation of study results”
“Thanks for sending this, Barney. I will read through (I was already aware of her views via Twitter) and then we can talk about it in due course”
“Well, she did draw attention to it. She said it publicly”
“Do you agree that, if she was right, she was performing a public service; she was writing something in the public interest?”
“I believe that is why she does what she does, because she believes in it”
“Hi Colin – below is Zoe Harcombe’s latest newsletter. I’ve been away since Friday so will sit down and see where we are this far. Anyone reading this kind of stuff is likely to be very convinced. I would say. I have to admit, I’ve not read Malcolm Kendrick’s book. But I’m guessing it’s the same argument”
“… I’d love to get your take on this. Bit of background, Zoe [has] turned to studying nutrition, first giving diet advice from a lay perspective while selling diet plans – the Harcombe Diet – and now, having done a PhD, as an academic with a special interest in statistics. In January, she published her latest diet book. She’s one of the statin deniers I’m looking into right now and a very clever one. We are planning to publish next week or the week after. Her argument seems convincing. But is she right? I suspect not…”
“Of course she’s not right. Zoe Harcombe cherry picks as much as the other side. I am afraid I came across her (a lot) when [redacted for source protection]. He shares your views – she’s a clever flawed protagonist. However, I do not have the time or inclination to take on a well known blogger who has devoted her life to this. You might be better off asking Rory Collins in Oxford for help – he’s as outspoken as she is, knows the data backwards and is much more heavyweight academic. Only problem is she will cry ‘big pharma’! Alternatively see if [the British Heart Foundation] can field someone? It really should be something they are prepared to stand up to…”
“Hi Rory, thanks so much for your time yesterday. I’m interested in this study. Malhotra was invited on TV etc. to publicise the findings. It’s a bit difficult for me to understand, but am I right in thinking they managed to find a total of 9 observational studies in total that recorded [cardiovascular] deaths, and that in those, low cholesterol was associated with a higher risk of death, while higher cholesterol was associated with a lower risk of death?”
“Hi… as u know I’m doing this deep dive into statins deniers. One of the things they argue is that eating [saturated] fats has no relevance to LDL levels in the blood is this right? Would you give me a simple biochemical type explanation as to how we know it does? NHS and Heart UK both list eating too much sat fat as key factor [in] raising LDL”
“As does the AHA – whereas the original data actually derived from studies done back in the 1950s to 1970s and often confounded the intake of different fats with changes in carbohydrate contents which may have muddied the waters. Also much of the data relied on stuff like the debateable Ancel Keys epidemiological studied (sic) as well as ‘force feeding’ small groups of people (often 10-20 medical students or patients) for a few weeks with controlled diets. Most of the studies found that high intakes of saturated fats were associated with higher levels of LDL that (sic) diets high in poly- or monosaturated fats. (The LDL increases were actually noted to be increases in LDL particle mass and may actually have represented an increase in big fluffy (less atherogenic) LDL. The data is really old and the metabolic pathways were variable – sometimes different individuals had different responses… I can get you some abstracts (or you can search google scholar for some) but getting full papers is hard online”
“Are you able to sum up how we know it does?”
“I’ve never focused overly on low saturated fat diets for this reason. But I do focus on high mono/polyunsaturated fat diets [redacted] And the data on genetic LDL and [coronary heart disease] as well as the data on drugs which act on LDL like stating [sc. statins] and PCSK9I are more persuasive”
“So Kendrick is right?”
“I’ve never actually read him, mea culpa”
“The top bit of advice from everyone is too much sat fat is partly behind raised cholesterol. He said this is rubbish and not supported by evidence”
“But I wouldn’t like to have to defend the argument that high intake of saturated fat raises LDL cholesterol. Or that it necessarily worse than a high carb diet…”
“Thanks all so much for your help with this article so far. One area I’m still unsure how to approach is the one about what CAUSES high cholesterol… Can you tell me: what according to the best evidence, raises LDL and how, and is it true that ‘eating too much saturated fat’ is one of those causes? If so, how does it happen? I’m not concerned if this is, in fact, shaky science. We all know that the original advice to avoid eating foods that contain cholesterol was debunked. It would be fine to say this is one area that these people may have a point, and might even add some needed balance. However if it is true to say excess saturated fat in the diet causes raised LDL, then we should say how we know in detail”. (2) at 11.49, Professor Baigent responded: “The evidence that higher saturated fat consumption leads to an increase in blood LDL cholesterol comes from so-called ‘metabolic ward studies’, which are randomised trials done under strict conditions whereby different study arms are allocated to different diets. One of our colleagues, Professor Robert Clarke… conducted a meta-analysis of such trials, which helps to provide an overall summary of their findings – see link https://www.bmj.com/content/314/7074/112.long. Being randomised to deduced consumption of saturated fat caused a reduction in LDL cholesterol (and this reduction was much larger than the reduction achieved by reducing dietary cholesterol). Hence, by implication, increasing saturated fat consumption in the population will cause an increase in the population’s average LDL cholesterol concentration. The mechanism by which saturated fatty acids increase LDL cholesterol is complex, and it may be that it would be best to speak to Robert Clarke about this. He will be able to direct you to an up-to-date source of information”. (emphasis in original) (3) at 11.50 Professor Collins responded: “I’m copying in my colleague Robert Clarke who has done analyses of randomised ward-based trials of the effects of various diets on LDL-cholesterol levels which show that increased consumption of saturated fats does increase LDL cholesterol levels. As to the separate question as to why increased intake of saturated fats increases LDL cholesterol levels, the simple explanation is that the liver makes LDL-cholesterol from saturated fats. (Most of the cholesterol in the body is made in the liver rather than, as you note, obtained from eating cholesterol itself.)…”
“FYI. Obviously this is confidential… but I wanted to share”. (5) at 12:29, Professor Sever responded to Professor Collins email: “Dear all, To convey a simple message to the public, should we say that the level of cholesterol in the blood is determined by the persons genes (on average about 60%) and their diet, and the saturated fat in the diet is a major contributor to the latter. Does anyone disagree?” (6) at 12.39, Professor Sever suggested that Mr Calman should contact Tom Sanders as a person who would be “good on diet and cholesterol”. (7) at 12:57, Robert Clarke provided Professor Sanders email address and also sent Mr Calman a copy of the paper to which Professor Collins had referred. (8) at 13.32, X responded to Mr Calman: “I would be interested to see Robert Clarke’s summary – and to see if he is cherry picking! As you say, doesn’t change the message about the risks of LDL and statins but does change people’s perception of dietary advice”. (9) at 13.41, Mr Calman forwarded Mr Clarke’s email and paper to X (without comment). (10) at 21.11, X emailed Mr Calman: “Interesting. Clarkes paper is a v old study – and looking at the data it is heavily skewed by the Minnesota Coronary Experiment (MCE) (see Franz 1989 – incidentally co author Ancel Keys) which include over 4,800 subjects (all the others he included in this meta analysis had around 10-20 subjects!) This MCE study showed a fall in total cholesterol but I don’t think it analysed LDL. It was also conducted at a time when the saturated fats they used were high in trans fats – which DO raise cholesterol. Incidentally the study was reanalysed in 2016 using some unpublished data and confirmed that the unsaturated fat diet lowered cholesterol compared to the saturated fat diet. It also seemed to suggest a higher mortality on a v high linoleic acid (unsaturated) diet compared to the high sat fat diet – but there were some significant inconsistencies in the study reporting and a huge number of subjects lost to follow up, which may make this analysis useless Do Kendrick and Harcombe rely on this?”
“Prior to me sending this back to the Profs, I wanted to show the first draft of the statins deniers article to you [redacted] cardiology-related and someone who isn’t involved in the row. You always give a really balanced view. It’s long and windy, and it’ll come down by at least 1,000 words, but I’d still appreciate hugely you view (sic) and any comments or suggestions. I think we’re getting a comment from Matt Hancock to run in it also. And the sat fat bit is still to sort out!”
“Dear all, thank you again for all your input into this article so far. I wanted to readdress the issue of finding a case study. One of the key factors in your collective argument is that criticism of statins discourages use amongst high risk patients, and this is a public health threat. Since putting calls out we have been inundated by stories of people who have stopped taking statins and felt far healthier. We’ve had two quite dramatic stories of patients who have been taken off statins by their doctors because of developing serious liver problems, and then died. The families themselves both naturally question whether statins caused the problems. What we haven’t had is a single story which backs your thesis, and obviously I’m concerned. I think it makes us look rather weak to use a very historic story about Clinton. What I do not want this piece to be is simply another exercise in singing to the choir and I fear without a real life example, we may be veering towards it all just seeming like scary theories and doctors saying ‘because I said so’. What has struck me is that the reason Kendrick, Malhotra, Harcombe and their ilk have really struck a chord is because they are great, emotive communicators. What we’re offering is a chance for you all to be that too, and we are planning to devote an unprecedented amount of space to this. Have any of you hear a real life example of someone who has suffered a heart attack or stroke because they declined/quit statins because they thought they didn’t really work anyway, or similar? I really want us to do everything we can to make this work. Please do ALL let me know asap today your thoughts about how to move forward”
“Thanks Colin – I understand your view but you’re not right on this. Our piece is primarily looking at the evidence – but alongside this a case study brings home to readers that all this really does happen to/affect real people like them. It would run as a few hundred words, alongside the many thousands of words looking at the science. From an objective perspective, having been looking at this story over the past fortnight, I’d wager anyone reading our piece will agree you win hands down in terms of facts. Where you are falling short, and have been for some time, is being able to get your message across in a way that is persuasive. Please do trust our experience in communication here, we put out Britain’s most read and trusted newspaper health content and have done for decades”
“The decision to increase use of statins is based on trial data only a few chosen people have seen. We need to demand greater transparency about the research on these drugs. Why aren’t we looking at changes in lifestyle that reduce heart disease risk instead of medicalising vast numbers of people?”
“When I was asked to prepare all the documents that I relied on when the complaint was made, I then started going back through all of the blogs and pulling them off, reading them and trying to work out which ones I had been reading, which ones were relevant, and contributed to the four broad areas that we talked about in the article… … When I came to preparing all of the information, I want back over the tweets, the historic tweets, and picked out things that I thought looked familiar… To the best of my memory, they were the things that I’d looked at during the preparation.”
“Having spoken to a colleague of yours by phone, I was told just to pop an email through to your office. I hope this finds you well. We’re getting in touch after a joint editorial published in the European Society for Cardiology’s European Heart Journal, signed by the Editors of 30 of the world’s most respected peer reviewed medical journals, claimed that recommendations to take heart-attack preventing statins are often ‘rejected’ by patients due to ‘widely disseminated incorrect information that vastly overstates the risks of these drug.’ Following this, on the 3rd of March The Mail on Sunday is set to publish an in-depth investigation into the proliferation of ‘fake news’ on statins – and debunk the myths that surround the medication. Our article will carry evidence that refutes the most commonly circulated false claims, including: the idea that statins ‘don’t work’, ‘do more harm than good’ and that side effects ‘are hushed up’, by doctors and researchers who have a conflict of interest as they are ‘paid’ by drug companies. We do this with input from the world’s leading researchers including Professor Sir Rory Collins, Professor Colin Baigent and Professor Robert Clarke of Oxford University, British Heart Foundation President Professor Sir Nilesh Samani, Professor Peter Sever at Imperial College London, and others. Recent evidence from the London School of Hygiene and Tropical Medicine suggests that public controversy over statins caused by such misinformation prompted an estimated 200,000 people in the UK to stop taking the pills in one six-month period. The authors of the study also claimed there could be 2,000 extra heart attacks or strokes over the following 10 years as a consequence. While recognising the importance of public debate The Mail on Sunday – which carries the only health section on Fleet Street that’s checked and approved by doctors – believes this is hugely worrying, and plans to set the record straight as part of our campaign to Fight Fake Health News. We feel it’s important to include a comment from the Health Secretary, giving your view on the problem of fake news about statins, which is undeniably damaging to public health. The comment would take a prominent place in the article. Please do let me know how we might make this happen – 10 minutes on the phone this week would be ideal. Many thanks and do also let me know if you need any further information”
“I’m sure we can help”
“… by this point in my preparation of the Health Section Article each of the Claimants and Dr Malhotra were firmly in my mind as potential subjects of the reporting. I have no reason to doubt that I mentioned both of the Claimants’ names (as well as Dr Malhotra’s) to Syeda Hasnain when we spoke, though I cannot say definitively and do not have a note of that call. We spoke for some time. I believe I would likely have said: ‘you probably know the people involved, people like Aseem Malhotra, Malcolm Kendrick and Zoe Harcombe’. I see no reason why I would have left either of the Claimants (or Dr Malhotra) out in that conversation. I certainly believe that I was clear that the piece would focus on individuals. It’s also supported by the fact I referred to specific individuals in a follow up email sent to Syeda Hasnain at 16.19 … after our call… I note that I did not name Dr Harcombe in that follow-up email. That was likely because she is not a GMC registered doctor…”
“I made it very clear that this is going to name individuals. I name the individuals we are going to name and in [the follow up email]… I don’t think I could have been clearer… To my memory I mentioned all three to Syeda”
“Hi Syeda, thanks for your time today. I’m glad you think this is a worthwhile piece – as you can see from the attached editorial, the spread of fake news about statins is something many of the world’s leading cardiologists are deeply concerned about. A press release on the LSHTM study is here [link provided]. They call it ‘a period of intense debate about statins’ but essentially, what they’re talking about is fake news. Prof Liam Smeeth, who led the study, is on record as saying so and will be talking in our forthcoming article. In terms of how much this is a problem within UK patient population, to quote them: ‘Scaling their findings up to the UK population, the researchers estimated that, assuming the intense media coverage was the cause of the observed changes, it could have resulted in more than 200,000 patients across the UK stopping statin therapy in the six months following the exposure period... they estimated there would be at least 2,000 cardiovascular events over the next 10 years, which would not have occurred if these patients had continued taking statins.’ And the fake news is very much home grown too: at least two of the widely quoted statins deniers, Dr Malcolm Kendrick and Dr Aseem Malhotra, are GMC registered and see patients in the UK right now. Below is the letter to Matt Hancock. Thanks again for looking at this. If we could get a statement by the end of the week echoing these concerns and encouraging patients to follow evidence based advice, it’d be great”
“I really feel the main thing this now needs is the political input – we have the world’s leading clinicians, as outlined in my email, talking about how they feel misinformation on statins is potentially a bigger threat than the MMR scandal, evidence that people who have had heart attacks have stopped taking statins after reading doctors in the media claiming they don’t need them, and evidence that this might have resulted in more heart attacks, stokes, and deaths. These incredible doctors have devoted their lives to protecting public health. And yet their message is being lost amid huge amounts of misinformation and falsehoods than are not back with a shred of credible evidence. If the Secretary of State gives them his backing, it will send a strong message”
“Really sorry this is in clearance – am chasing for you now! Will get over to you ASAP”
“Fab, thanks. Would be keen [to] brief you in more detail about the piece once we have the quote…”
“Thanks all. This is EXACTLY what we’re after”
“I had no reason to think that, no”
“Did you really believe that if Mr Hancock had known you were going to name individuals, let alone individuals… he would have given you a quote without any strings attached containing this sort of language?”
“That was the official quote from the Secretary of State for Health and Social Care, and I took it as read and I was transparent about our project in emails and conversation with the department and that was what he provided. That was what he provided”
“Did it not occur to you that you might have put Mr Hancock in jeopardy because you were -- he was entrusting you with some statements that would be highly defamatory of … GMC-registered doctors if anyone was named? Mr Calman: “As I said, this was the comment from a government minister. It is not for me to question the comment coming from the government minister and go back and say, ‘Is he sure?’”
“Matt, can I confirm that you WERE NOT told by the Mail On Sunday that the statin article was specifically attacking myself and Zoe Harcombe? Will be good to know. I’m speaking to Tom Watson about it today… And there will be an official robust response”
“Yes, I had no idea they’d link it”
“… Now I must mention, and I think this is really important and crucial, two points. One is, I have had a read through the article and I must say that it is inaccurate, it is distorted, it is defamatory and it’s misleading and I will be writing to the Mail on Sunday and also contacting the Independent Press Standards Organisation, IPSO, to call for it to be at least majorly corrected if not retracted and on the Matt Hancock issue, what’s interesting is I actually met Matt Hancock last week, I was invited to meet him. To discuss how we can help curb the epidemic of type 2 diabetes in this country and he has been, you know, I’ve had a very good rapport with him, he’s been supportive of my work. He realises that we have a big problem here and there are certainly lifestyle issues that we can implement that will help patients reverse a disease and reduce the need for medications. Matt actually messaged me today to tell me that he had no idea that I was linked to this article. So there are some serious question marks about the journalism involved in this particular piece in the Mail on Sunday, but I am very happy to talk about the evidence around statins and what I advise my patients…”
“Thanks so much for working with the MOS on our investigation last week. We’ve heard the TalkRadio broadcast, which is defamatory. Our correspondence, below, is now with the managing editor of The Mail on Sunday, as it’s now become a serious matter. I look forward to your response”. (2) Ms Wilson responded, at 14.36: “Thanks Barney. We are aware of this issue – I will come back to you shortly”. (3) Mr Calman replied, at 14.44: “Thanks Sara, we’re keen to deal with this swiftly as obviously this claim is now being widely circulated online. (4) Not having received a response, Mr Calman followed up with a further email at 18.18, copied to (amongst others) Ms Hasnain and Mr Wellington, the then Managing Editor of the Mail on Sunday: “We’re surprised Matt Hancock would make such a specific and strongly worded comment on an investigation into doctors making false claims without asking who the doctors are. It seems shambolic that he would not be provided with the facts. It now leads to the question why the Secretary of State for Health was privately messaging Dr Malhotra this morning, and we welcome his clarification on the matter”. (5) Ms Wilson responded, at 19.41, she and Mr Calman clearly having spoken in the meantime (but no note having been taken by Mr Calman): “As I said on the phone, there has been no suggestion from us that Matt Hancock wants to retract his statement and he remains supportive of your campaign. This was a general comment warning about clinicians spreading misinformation it was not intended to single out any one individual. We are still very happy for you to reference his support for your campaign in any follow up coverage and to refer to his statement. However I’m sure you’ll appreciate that we cannot comment on Mr Hancock’s and Dr Malhotra private correspondence”
“… I considered that Matt Hancock had a very clear idea of what and who he was commenting on. I found it contradictory that we could get such a straight response from Matt Hancock and then hear something seemingly different on the radio from Dr Malhotra”
“I called Sarah Wilson at the DHSC. She said that there was no indication that Matt Hancock would like to withdraw the statement. They confirmed that the statement was about clinicians (the identities of which they knew) but the statement was not meant to be about one particular clinician. She said they would provide me with a written response shortly”
“Regarding Matt Hancock, prior to publication we contacted the Department of Health and Social Care and said we intended to publish an article stating that statins deniers were circulating claims that statins are not effective and that side effects are begin hushed up by scientists who are being paid by the drug companies. We said we intended to rely on evidence from the London School of Hygiene and Tropical Medicine suggesting that public controversy and misinformation over statins has caused 200,000 UK patients to stop taking the drug and, as a result, there could be 2,000 extra heart attacks or strokes over the following ten years. We indicated that you could be named in the article. Matt Hancock provided us with the statement. Following publication, and your statement about your private correspondence with Mr Hancock, we checked with the DHSC who confirmed that Mr Hancock was standing by his statement in full”
“Oh dear Matt! Really?”
“Well, he wasn’t singling out any individual. If he had been, we would have quoted him as saying so”
“The health secretary said these kinds of pernicious lies have no place in our NHS and I welcome the Mail on Sunday’s work to shine a light on the scale of the problem”
“I believe that is why she does what she does, because she believes in it”
“The point is, and it says this very clearly in the article, it is not that they’re deliberately telling falsehoods or they’re liars, it is that they’re simply mistaken, and they’re mistaken with very grave consequences. You know we call them ‘statin deniers’, we don’t call them ‘statin liars’… I do not believe, and have never believed, and it was never part of my original discussion with Barney or part of the story that these people were saying these things knowing them to be false. I mean, why would they do that? That just isn’t the story”
“… that across the UK there was an excess of 218,971 patients who stopped taking a statin in the six months after the media coverage” and “… that increases in statin cessation due to the period of media coverage of side-effects could result in at least 2,173 excess cardiovascular events over 10 years, depending on the proportion of ‘stoppers’ who re-started later. Our calculations were based on several assumptions and approximations and clearly could not take account of future chances in statin use and perceptions of other developments in prevention of cardiovascular disease. Varying assumptions also lead to substantial changes in the outcome, meaning these estimations should be interpreted with caution. We also cannot know from our data the extent to which patients were appropriately informed about the risk:benefit balance of statins and whether those who have stopped would have been aware and accepting of the consequent increases in risk of cardiovascular disease. Patients can vary widely in the choices that they make about long term preventative drug treatment, and some choose not to take drugs that will extend their life. Finally we did not attempt to take into account any possible benefits of stopping treatment with statins, which might have offset the increase in risk.” (4) The conclusion was: “Controversy over the risks and benefits of statins reported in both the medical and popular press was followed by a transient increase in patients stopping treatment prescribed for primary and secondary prevention… This research highlights the potential for widely covered health stories in the media to have an effect on real world behaviour related to health-care and could be used to inform future interactions between clinicians, researchers, the academic press, and the wider media.”
“Thank you for sending us your paper. We sent it for external peer review and discussed it at our manuscript committee meeting. We recognise its potential importance and relevance to general medical readers, but I am afraid that we have not yet been able to reach a final decision on it because several important aspects of the work still need clarifying. We hope very much that you will be willing and able to revise your paper as explained below in the report from the manuscript meeting, so that we will be in a better position to understand your study and decide whether the BMJ is the right journal for it”
“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. [1] ZH comment – these are relative risk numbers, not absolute risk. Following the 2012 CTSU publication about statins The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta- analysis of individual data from 27 randomised trials, published by The Lancet17 May 2012 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)60367-5/fulltext – see [204] below. , I wrote to the research team asking for access to the raw data so that I could examine absolute risk (among other things). I was refused access to the data. The exact reply was: “The CTT Collaboration holds data on a very strict basis and is not able to provide participant level data to third parties”
“The median postponement of death for primary and secondary prevention trials were 3.2 and 4.1 days, respectively”
‘Lives are at stake [due to the] wanton spread of medical misinformation. It is high time that this stopped.’
‘High cholesterol is not even associated with high heart disease, let alone a cause of it.’
“The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials” (relied upon by the First Claimant in paragraph [1] of her response to Mr Calman). The summary stated: “Statins reduce LDL cholesterol and prevent vascular events, but their net effects in people at low risk of vascular events remain uncertain”
“Professor who sparked statins row says government should intervene” (relied upon by the First Claimant in paragraph [10] of her response to Mr Calman), which included the following: “Prof Sir Rory Collins says he has little confidence in British Medical Journal’s inquiry into papers on side-effects of drugs. The Oxford professor who triggered a public row over statins says the Department of Health and other authorities should intervene to ensure the public gets accurate information on the risks and benefits of the potentially life-saving drugs. Prof Sir Rory Collins said he had little confidence in an inquiry convened by the British Medical Journal to decide whether two papers it published last year that made an error on the extent of side-effects should be completely withdrawn. The papers published by the BMJ were by John Abramson, a clinician working at Harvard medical school, and Aseem Malhotra, a cardiologist in the UK. Abramson said statins in low-risk patients did not reduce mortality. Both authors said that in the low-risk group the side-effects meant they sometimes did more harm than good. The authors have retracted statements on the frequency of side-effects but Collins said that as long as the papers were in circulation, they would wrongly undermine confidence in the drugs, and he did not believe the inquiry was truly independent. He said: ‘I don’t think it is appropriate for the British Medical Journal to investigate itself,’ and called on the General Medical Council, the Academy of Medical Sciences or the Department of Health to investigate. He said when the BMJ ‘gets things wrong, it doesn’t correct them properly; when it’s shown it gets things wrong, it doesn’t make that clear – for example blaming the peer reviewers when it wasn’t the peer reviewers’ fault – and they shouldn’t be in a position where they are investigating themselves. That wouldn’t be happening in any other sphere.’ Cholesterol-lowering statins are life-savers, helping prevent heart attacks and strokes in people who have already had one and so are at high risk of another. But the battle now raging is over the use of the drugs in healthy people at low risk. Draft guidance from the National Institute for Health and Care Excellence (Nice) has recommended that everybody with a risk as low as 10% over 10 years (rather than 20% as now) should be eligible for statins from their GP. About 7 million middle-aged people are now taking a daily statin and the regulator’s proposed guidance could extend that to 5 million more. This week, one of the two BMJ authors and seven other doctors, including the president of the Royal College of Physicians, Sir Richard Thompson, and a former chair of the Royal College of GPs, Dr Clare Gerada, wrote to Nice and the health secretary, Jeremy Hunt, asking for the guidance to be delayed. The letter questioned the benefits and side-effects in low-risk people and claimed the true picture was distorted because drug companies had not put trial data into the public domain…”
“In October 2013 the BMJ published two articles in the same issue: an Analysis article by Abramson et al arguing that cholesterol lowering guidelines should not be widened to include statin therapy for low risk individuals (five year risk <10%) and an Observations article by Malhotra suggesting that saturated fat is not the main cause of cardiovascular disease. The Abramson et al article questioned the balance of risk and benefit presented in the recently updated Cochrane review and the 2012 Cholesterol Treatment Trialists’ (CTT) Collaboration meta-analysis (on which the updates to the 2013 Cochrane review are largely based). Both articles quoted an article by Zhang et al to claim that the rate of side effects with statins was around 20%. This was an error. In fact, Zhang et al referred to ‘statin-related clinical events that may be interpreted as adverse reactions by patients or their clinicians’. As Zhang et al themselves pointed out in a rapid response, ‘implicit in this definition is the recognition that the causative association between each identified event and statin use was unknown.’ This error of interpretation was first suggested in a rapid response from Takhar immediately after publication of the Abramson et al article and subsequently clarified by Zhang et al themselves in a letter published in June 2014. Numerous rapid responses were posted, reflecting a vigorous debate on the merits and limitations of statins for those at low risk of cardiovascular disease. On30 October 2013 , a few days after publication, Professor Sir Rory Collins, professor of medicine and epidemiology at the Clinical Trial Service Unit at Oxford University and an author on the meta-analysis by the Cholesterol Treatment Trialists’ (CTT) Collaboration published in the Lancet in 2012, sent an email to the editor of the BMJ, Dr Fiona Godlee, stating that the BMJ seemed to have taken a stand against statins and that there was a danger that misrepresentation of the evidence in the BMJ could cause harm. He discussed this in person with Fiona Godlee in December 2013 and talked her through a set of slides (later submitted to the panel with additional annotations, SP16a). At that meeting Fiona Godlee invited Rory Collins to write an article presenting evidence on the benefits and harms of statins: ‘Although your article would be a response to the two articles, and to Abramson et al in particular, it would be helpful if you could use the opportunity to set your piece in the wider context of the evidence on the benefits and harms of statins.’ (See SP13, email 2 December). Following this discussion Rory Collins submitted a number of written, but not-for-publication, criticisms to Fiona Godlee, focussed mainly on the Abramson et al paper, and was again invited to write an article in response. At the time of this report he had not yet done so in the form of a submitted article. In another letter to Fiona Godlee, marked ‘not for publication’ and dated28 April 2014 , Rory Collins called for retraction of both papers, writing: ‘What the BMJ needs to do is withdraw these seriously damaging claims explicitly and unreservedly with a clear explanation of why they are so wrong and what is likely be correct, and to demonstrate that it is serious about rectifying the damage that it has caused by retracting both of these papers.’ He emphasised the seriousness of his concerns, describing: ‘the need to rectify the harm that has been caused –perhaps resulting in large numbers of unnecessary deaths, heart attacks and strokes among patients at elevated risk – by misleading doctors and the public with gross over-estimates of the rates of side-effects with statins.’ (SP20) On15 May 2014 , corrections were posted for both articles, withdrawing the statement that side effects of statins occur in about 18-20% of patients. ‘The authors withdraw this statement. Although it was based on statements in the referenced observational study by Zhang and colleagues, that ‘the rate of reported statin-related events to statins was nearly 18%’, the article did not reflect necessary caveats and did not take sufficient account of the uncontrolled nature of the study.’…”
“The effect of statins on average survival in randomised trials, an analysis of end point postponement” (relied upon by the First Claimant in paragraph [5] and the Second Claimant in paragraph [4] of their respective responses to Mr Calman) (“the Kristensen Study”). The following “Abstract” from the paper summarises the study and its conclusions: “Objective: To estimate the average postponement of death in statin trials. Setting: A systematic literature review of all statin trials that presented all-cause survival curves for treated and untreated. Intervention: Statin treatment compared to placebo. Primary outcome measures: The average postponement of death as represented by the area between the survival curves. Results: 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. Conclusion: Statin treatment results in surprisingly small average gain in overall survival within the trials’ running time. For patients whose life expectancy is limited or who have adverse effects of treatment, withholding statin treatment therapy should be considered”
“… we decided to look at like not total cholesterol sorry this all terminology gets very arcane very quickly. We looked the part of cholesterol called bad cholesterol in popular parlance which is LDL cholesterol and because this hadn’t been done before we also looked in the elderly because there had been some idea that as people became older that cholesterol or LDL cholesterol was actually not a risk factor or attenuated. So we then decided to try and find all the work that had been done looking at the levels of LDL in groups of people and looking at over 68,000 people we found that essentially after the age of 60 … if you have a higher LDL bad cholesterol level you will actually live longer and there is no increased risk of cardiovascular disease. That’s essentially what we found…. What is going on is that LDL and/or cholesterol is not actually a cause of cardiovascular disease.”
“Of the 491 patients who entered phase A… muscle symptoms occurred in 209 of 491 (42.6%) while taking atorvastatin but not while taking placebo”
“A leading Oxford medical researcher who says statins are safe is at loggerheads with a company that makes ‘misleading claims about the drugs’ side effects to sell a diagnostic kit he invented. More than 6m people take statins – drugs which reduce cholesterol and save an estimated 7,000 lives a year – but there is a fierce debate about the benefits and side effects. Sir Rory Collins, a professor of medicine and epidemiology at Oxford University, led a review into statins, published in The Lancet earlier this month, which found that not more than one in 50 people will suffer side effects. Collins, who believes millions more Britons could benefit by taking statins, is also co-inventor of a test that indicates susceptibility to muscle pain from them. In 2009, he and three co-inventors filed a patent for a genetic marker that identifies patients at increased risk of myopathy (muscular pain). The patent says that the incidence of myopathy is around one in 10,000 patients per year on a standard statin dose. The test, branded Statin-Smart, is sold online for$99 (£76 ) on a website that claims 29% of statin users will suffer muscle pain, weakness or cramps. The marketing material also claims that 58% of patients on statins stop taking them within a year, mostly because of muscle pain. Oxford University said Collins had raised his concerns ‘several times’ about ‘misleading’ marketing claims made by Boston Heart Diagnostics, the American company granted the exclusive licence for Collins’ patent by the university. Royalties from the licensing of the patent can be used to fund university research, but Collins and his co-inventors had waived personal fees… Peter Weissberg, medical director at the British Heart Foundation, described the Lancet review as a ‘masterclass in how evidence should be interpreted’. Experts at a briefing organised by the respected Science Media Centre described it as an ‘excellent’ review and warned of the damage that could be done by ‘uninformed scare stories’ on side effects. However, other medical experts have said they are dubious about the ‘vanishingly small’ level of side effects found in the trials. Trish Greenhalgh, professor of primary health care sciences at Oxford University said: ‘The authors did not highlight the huge biases that are going to happen when you exclude some people with side effects from the trials. The jury is still out.’”
“Below is the version of our piece. We can’t add anything, but we do still have time to make amends if there is anything glaringly inaccurate. Obviously things have had to [be] cut to fit, although it is running over four pages. I’ve not shared with you the case study/comment piece from me, as I feel your big interest is this bit. We’ve had responses from Kendrick and Harcombe, which I have tried to address throughout for balance. Malhotra declined to comment.”
“… WHEN approached by The Mail on Sunday last week, Dr Kendrick pointed to a 2015 study as proof of his much-made claim that the benefits of statins are negligible, and don’t extend lifespan. It showed 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’. Prof Baigent says: ‘The 2015 study Kendrick mentions only looked at life extension over the trial period of a few years. Statins are lifelong drugs, and the extension of life over a lifetime will be very much greater. And the important thing is statins extend healthy life. They avoid both disabling events like heart attacks and strokes. Simply focusing attention on extra duration of life is to ignore the fact that these drugs reduce disability.’ … Prof Samani says: ‘Heart attacks used to kill men in their 50s and even 40s, but thanks in part to drug therapies people are living longer, healthier lives.’ However, Dr Kendrick says: ‘My paper [which linked high LDL with a longer life] was the most read paper in the BMJ Open website for five months in a row and provides the rationale for a re-evaluation of cholesterol lowering guidelines.’ Dr Harcombe said: ‘I have examined the entire data provided by the World Health Organisation and found that higher cholesterol is associated with lower deaths, from [heart disease] and all-causes, in men and women, for all 192 countries in the world. ‘My PhD was an examination of the diet (cholesterol) heart hypothesis. I have studied this topic at the highest level for several years and I am entitled, if not obliged, to share what I have found.’ … In October 2013, the British Medical Journal published an article by Dr Aseem Malhotra in which he claimed a study had proved 20 per cent of statins patients were forced to stop taking them due to muscle pains, stomach upsets, sleep and memory problems and erectile dysfunction. Thanks to Dr Malhotra’s article, the figure was reported worldwide but within months was revealed to be a wrong. The researchers admitted the true quit rate was nine per cent. And it was unclear how many of those had genuinely suffered side effects. Dr Malhotra’s piece, and the study that inspired it, were ‘non-scientific and simply not true,’ says Prof Smeeth, who led a 2016 investigation by experts at the school into the rising numbers stopping statins as a result of the articles, and the debate – which included public statements from Dr Kendrick and Dr Harcombe – which followed. The editor of the British Medical Journal, Fiona Godlee, corrected the articles and was even forced to appear on BBC News admitting the mistake. Dr Kendrick claimed the change, asked for by Prof Collins, indicated ‘anyone who dares to criticise statins... is subjected to vitriolic attacks and a demand for silence.’ And in a 2014 blog post titled ‘It’s not about statins – it’s about censorship’ Dr Harcombe claimed£116 million had ‘been awarded to Colin Baigent and Rory Collins’ by drug companies, implying that was the real reason they sought the correction… … Responding to our investigation, Dr Kendrick said: ‘I believe people are being conned, deliberately misled. All of the industry-funded studies were positive. This is either a remarkable coincidence – or something else.’ Dr Harcombe said: ‘Rory Collins is trying to bully doctors and researchers into silence. It would be naïve not to think that sums such as£268 million from pharmaceutical companies to CTSU [University of Oxford’s research body, under which Prof Collins works] encourage recipients to aggressively encourage people to take those drugs. That’s 268 million reasons to silence debate.’…”
“Oh dear, what a shame. It is extremely disappointing how the balance of the article has been completely changed at the last minute by the influence of the unbalanced inclusion of quotes from Harcombe and Kendrick. In particular, the repeated allegation in the MoS that I have taken large sums of money from industry without making it clear – or allowing me to do so (by contrast with the extensive quotes from Harcombe and Kendrick) – that I personally (and staff in our Clinical Trial Service Unit as a whole) have had a policy for over 30 years of not taking any money either directly or indirectly (i.e. through the University) from industry ... no honoraria for talks, no consultancies for advice, no personal payments at all. By contrast, you have removed any mention of the financial interests of the statin deniers that are served by their false claims, and the loss of your previous ending (which would have helped readers to understand your conclusions) is instead replaced by yet another emotive and unsubstantiated slur against me. I have added a few comments on the draft, but it really does need a major revision back to somewhere closer to what it had been (otherwise all of your hard work will have been wasted). I realise that it is late in the day ... but then you have only just sent us this massively revised text ... and that this will be an unwelcome suggestion, but I would urge you (particularly given how much work you had put into trying to get the evidence straight) to hold back publishing the article until you can get the balance right and the messages clear”
“Aseem Malhotra’s website says he is an ‘award-winning NHs cardiologist’ and ‘honorary consultant’ at Frimley Health NHs Foundation Trust in surrey and the Lister Hospital in Stevenage, Essex. However when The Mail on Sunday contacted Frimley, they said he did not work there but ‘did a few clinics here a few years back’. His secretary at the Lister explained that Dr Malhotra, 41, was a locum – shift-worker – cardiologist who saw patients there only on a Wednesday afternoon. Appointments are available at a private practice in Harley Street, London, where he charges£500 for a first consultation and£300 for a follow-up. His diet book, The Pioppi Diet, was branded one of the ‘top five worst celeb diets to avoid in 2018’ by the British Dietetic Association. Dr Malcolm Kendrick, 60, is author of five books (the best-read has sold a modest 22,000 copies) and works as a GP for two NHS trusts, East Cheshire and Central Cheshire Integrated Care Partnership. For£50 a year, you can become a member of The Zoe Harcombe Diet & Health Club. The Cambridge maths graduate has a PhD in public health nutrition but has never worked as a medical doctor”
“REVEALED: Vested interests of the ‘experts’ who say don’t take statins SO who are these highly-influential sceptics defying years of robust research on statins? Malhotra’s website says he is an ‘honorary consultant’ at both Frimley Health NHS Foundation Trust and the Lister Hospital Stevenage. However when The Mail on Sunday contacted Frimley, they claimed he did not currently work there and his secretary at the Lister explained he was a locum – shift-worker – cardiologist who only saw patients there on a Wednesday afternoon. He charges£500 for a first consultation, and£300 for a follow-up at a Harley Street clinic. 41-year-old Malhotra’s most recent book, The Pioppi Diet, was branded one of the ‘top five worst celeb diets to avoid in 2018’ by the British Dietetic Association, yet he urges blog readers to choose it over statins. Kendrick, meanwhile, is author of five books on the statins debate, the best-read of which has sold a modest 22,000 copies. The 60-year-old doctor is employed by East Cheshire NHS Trust and Central Cheshire Integrated Care Partnership. And for£50 a year, you can become a member of The Zoe Harcombe Diet & Health Club. The Cambridge maths graduate has a PhD in public health nutrition, and regularly blogs about cholesterol and heart disease. All three owe some, if not a large part of their status to their stance as statins deniers – and have profited from it. Despite such strong evidence to counter their claims, they are resolute. Have they just got too much to lose if their arguments are disproved?”
“However, some medics dispute the benefits [statins] bring – with a few even falsely claiming they cause serious and widespread damage to health…”
“Looks good! I’d say ‘wrongly claiming’ – trying to avoid anything that could look like we say they’re deliberately lying”
“On receipt of Dr Kendrick’s right of reply… I forwarded it on to X and asked the experts to comment on the [Kristensen Study – see [209] above], which found that if you took a statin for five years, the increase in life expectancy would be on average 3.5 days (3.2 and 4.1 days for primary and secondary prevention respectively). I had already discussed this line of argument, that statins don’t prevent death, with Professor Baigent. Professor Sever responded that most patients fear the profound disability associated with a severe stroke and incapacitating consequences of coronary heart disease, and heart attacks leading to heart failure, the risk of which are (sic) reduced with statins. An analysis based on extended life days was in his view less important than safeguarding quality of life. Professor Baigent stated that the two main problems with this study were that (a) statins extend healthy life by avoiding disabling events in isolation was to ignore the fact that these drugs reduced disability, which was of particular importance in older people, and (b) trials with a short exposure period of a few years’ duration (as this was) can only assess the extra duration of life that accrues over those few years. I know that the Claimants say that I did not have regard to any of the materials referred to me by the Claimants in their replies, but I think my answer above demonstrates clearly that I did. In addition to this, the Claimants referring to specific stand-alone studies that they believe support their stance comes back to the overarching point about one study or one review being not nearly as comparable as meta-analyses that combine the results of multiple studies. In any event, I did include a reference to the Kristensen paper that he referred to in his response and a summary of what Professor Baigent and Professor Sever said in response. Due to the length of the article, which was already substantial, it would not have been possible to enter into a back and forth over a single point such as this. Ultimately, the Kristensen study examined 11 studies, between two and six years in duration. My cardiologist source X suggested it was remarkable that, even given such a small selection of studies and timeframe, that a survival benefit was seen. Again, we could have focused endlessly on one aspect such as this, however, there was not space and more to the point, the Kristensen study did not refute the totality of evidence”
“The suggestion is that the statin deniers are simply wrong rather than dishonest”
“make no mistake: the statin deniers are no Barry Marshalls”
“Your proposed wording is not suitable as a statement by way of explanation and contradiction and is not acceptable to our clients. They are entitled to have made clear what misrepresentation is being corrected. The misrepresentation was that Mr Hancock, in his highly critical remarks to the Mail Online, had referred to ‘statin deniers’ and ‘doctors’. It needs also to be made clear why this is a correction relating to our clients, specifically, because they were two individuals repeatedly identified in the coverage as the ‘statin deniers’ and the ‘doctors’. Your proposed statement is drafted so as completely to obscure what is being corrected and why. We invite your client to publish this alternative: Dr Malcolm Kendrick and Dr Zoe Harcombe PhD In our special health report on March 3 2019 about statins, in which we described Dr Malcolm Kendrick and Dr Zoe Harcombe as ‘statin deniers’, we attributed to Health Secretary Matt Hancock that he had accused such ‘doctors’ and ‘statin deniers’ of needlessly risking patients’ lives by ‘spreading reckless and ignorant misinformation’ and of circulating ‘pernicious lies’, conduct which Dr Kendrick and Dr Harcombe deny. Mr Hancock did not use the term ‘doctors’ or ‘statin deniers’ and it has been confirmed to us by the Department of Health that Mr Hancock’s remarks had not been intended to single out any individuals. We wish to correct the impression that we gave to the contrary. This will need to appear in the hard copy, where it should be positioned as the first item in the clarifications and corrections column and online at the [website addresses given] at the top of the articles…”
“A defamatory meaning should not be ignored by a journalist if it is ‘obviously one possible meaning’ ([25]) or ‘glaringly obvious’ ([27]); to do so would not be reasonable. But if that threshold is not reached, the reasonable belief of a journalist who did not perceive the more damaging meaning falls to be assessed by reference to the less damaging meaning”. [83] It may be that these principles do not transpose directly into a situation such as the present, but I do not think the defendant can reasonably argue for any more generous test. She has never done so. She has not addressed the issue. The defendant’s argument has always been that her conduct should be assessed exclusively by reference to what she reasonably believed the GAT to mean, and that on that footing it was reasonable for her to believe that it was in the public interest to publish the Factual Allegation and the Opinion. That, in my view, is simplistic and wrong. When assessing the reasonableness of a belief that it is the public interest to denounce a person as dangerous and stupid for what they have said in a public statement, it must be relevant that the statement has an obvious alternative and lesser meaning which is not worthy of such denunciation. Here, the Judge was entitled to conclude that the defendant ought reasonably to have appreciated that the GAT could also be interpreted as conveying the hypocrisy meaning and that it was therefore unreasonable for her to believe that presenting the position unambiguously, as she did, was in the public interest. [84] This approach seems to me consistent with one strand of the authorities to date, which is that “a belief [is] reasonable for the purposes of s.4 only if it is one arrived after conducting such enquiries and checks as it is reasonable to expect of the particular defendant in all the circumstances of the case”: Economou [2017] EMLR 4 [241], approved [2019] EMLR 7 [101] and endorsed by the Supreme Court as “no doubt helpful” in Serafin [67]. [85] I see no inconsistency with my judgment in Yeo, aspects of which are relied on by the defendant. In the passages relied on, at [175] and [179], I said that in a case such as that one “it will be ‘fair’ to present readers with factual conclusions honestly and reasonably drawn by journalists who were themselves witnesses to the key events; it is permissible to summarise, and to be selective; … fairness does not require the publisher to present the reader with all the factual material that could support a competing assessment … it is not incumbent on the responsible journalist to lay out for the reader all the pros and cons relevant to a particular conclusion”
“… At the stage of the assessment as to what information the defendant had and what inquiries s/he made, Lord Nicholls’ third to fifth factors are likely to remain valid in many cases: ‘3. The source of the information. Some informants have no direct knowledge of the events. Some may have their own axes to grind, or are being paid for their stories. 4. The steps taken to verify the information. 5. The status of the information. The allegation may have already been the subject of an investigation which commands respect.’”
“In [Flood -v- Times Newspapers Ltd[2012] 2 AC 273 ] ..., the defendant published an article taken to mean that there were reasonable grounds to suspect that the claimant, a police officer, had corruptly taken bribes. The allegation was false. This court held that the defendant nevertheless had a valid defence of public interest. Lord Phillips of Worth Matravers, the President of the court, said at [26] that in that case analysis of the defence required particular reference to two questions, namely public interest and verification; at [27] that it was misleading to describe the defence as privilege; at [78], building on what Lord Hoffmann had said in the Jameel case at [62], that the defence normally arose only if the publisher had taken reasonable steps to satisfy himself that the allegation was true; and at [79] that verification involved both a subjective and an objective element in that the journalist had to believe in the truth of the allegation but it also had to be reasonable for him to have held the belief. Lord Brown at [113] chose to encapsulate the defence in a single question. ‘Could’, he asked, ‘whoever published the defamation, given whatever they knew (and did not know) and whatever they had done (and had not done) to guard so far as possible against the publication of untrue defamatory material, properly have considered the publication in question to be in the public interest?’. Lord Mance at [137], echoing what Lord Nicholls had said in the Reynolds case at p.205, stressed the importance of giving respect, within reason, to editorial judgement in relation not only to the steps to be taken by way of verification prior to publication but also to what it would be in the public interest to publish; and at [138] Lord Mance explained that the public interest defence had been developed under the influence of the principles laid down in the European Court of Human Rights.” [135] As Lord Wilson noted ([66]), theExplanatory Notes to the Defamation Act 2013 stated that the intention behind s.4 was to: “reflect the common law as recently set out in the Flood case and in particular the subjective and objective elements of the requirement now both contained in subsection 1(b)”. [136] In [60], Lord Wilson referred to Lord Brown’s question from Flood. To similar effect, in Economou [2017] EMLR 4 [241], Warby J held: “I would consider a belief to be reasonable for the purposes of section 4 only if it is one arrived at after conducting such inquiries and checks as it is reasonable to expect of the particular defendant in all the circumstances of the case”
“… having an agenda does not, in and of itself, disqualify a person including citizen journalists such as D1 and D2 from being able to benefit from a public interest defence. Indeed, in general terms many publications and professional journalists approach stories with what might be called an agenda. However, the agenda adopted by D1 and D2 meant that they approached what might be facts suggesting (at the very highest) that questions might be asked about the accuracy of the fundraising statements, as proving fraud and dishonesty on the part of Mr Packham.”
“Subsection (5) makes clear for the avoidance of doubt that the defence provided by this section may be relied on irrespective of whether the statement complained of is one of fact or opinion.”
“(1) The publication of any report or other statement mentioned in Schedule 1 to this Act is privileged unless the publication is shown to be made with malice, subject as follows. (2) In defamation proceedings in respect of the publication of a report or other statement mentioned in Part II of that Schedule, there is no defence under this section if the plaintiff shows that the defendant— (a) was requested by him to publish in a suitable manner a reasonable letter or statement by way of explanation or contradiction, and (b) refused or neglected to do so. For this purpose ‘in a suitable manner’ means in the same manner as the publication complained of or in a manner that is adequate and reasonable in the circumstances. (3) This section does not apply to the publication to the public, or a section of the public, of matter which is not of public interest and the publication of which is not for the public benefit…”
“Part 1 – Statements have qualified privilege without explanation or contradiction … 7. A fair and accurate copy of or extract from matter published by or on the authority of a government or legislature anywhere in the world… Part 2 – Statements privileged subject to explanation or contradiction 9. … A fair and accurate copy of or extract from or summary of a notice or other matter issued for the information of the public by or on behalf of – (a) a legislature or government anywhere in the world; (b) an authority anywhere in the world performing governmental functions…”
“The objects of providing [an opportunity to request publication of a letter or statement by way of explanation or contradiction] emerge clearly enough from a consideration of the section. The point of affording a special privilege to publishers of newspaper, radio or television reports concerning proceedings of public meetings of the specified kind is to recognise their particular role in a society which enjoys a high measure of freedom of communication. That role extends today to providing reports to the public, although the matters reported might later turn out to be inaccurate, unfair or defamatory of the persons mentioned. It is the public or official character of the specified meetings which, it has been considered, will ensure, at least in most cases, appropriate restraint against the reporting of irresponsible or groundless accusations. This purpose is made doubly clear by the closing words of proviso (c). Those words withdraw the protection otherwise applicable if the matter is ‘not of public concern and the publication ... is not for the public benefit’. The emphasis upon the public character of the meetings and the criterion of public concern and public benefit help to explain the true purpose of proviso (b). It is to enhance the information given to the public on a particular matter. It is also to recognise that, in the nature of the particular meetings specified, inaccurate, unfair or defamatory statements may be made which can then be published under qualified privilege. Fairness requires the balancing of that right with a provision, to those complaining about its exercise, of the opportunity to place a contradictory statement or explanation before the public. The request would have to be reasonably contemporaneous with the publication. It would not ordinarily be reasonable to expect publication of a letter or statement years or perhaps even months later. The criterion of the public’s interest must be kept in mind in giving meaning to the section, including proviso (b). … By the terms of the proviso, any such letter or statement must be ‘reasonable’. It was urged that this meant reasonable from the point of view of the person complaining or tendering the statement. However, in my view, ‘reasonable’, in this context, means objectively reasonable for the purpose for which the statutory facility has been provided. This is to allow already published facts to be contradicted or explained by those claiming to be hurt by the report of them. The reference to ‘reasonable’ is intended to control such matters as the length of the letter or statement, the terms in which it is expressed and the avoidance of gratuitous defamation of third parties. I do not regard the word ‘reasonable’ as affording an editorial veto to the publication of a letter which is strongly expressed or contains disputable propositions or arguable inaccuracies. After all, it is always open to the publisher to have the last word. It is not uncommon, where letters of complaint are published, for an editorial note to be added expressing the publisher’s reply. The sting of defamation often causes emotion and anger. That is the context in which Parliament has made provision for a letter or statement in reply to be given its statutory status. Publishers of newspapers who have considerable power to harm reputations should not be overly tender about complaints and expressions of anger when appearing in a letter or statement to which proviso (b) applies. … The proviso makes no express mention of editorial amendment, abbreviation or alteration. But neither does it expressly state that the letter or statement must be ‘accurate’. In the real world, if some aspect of a letter or statement were thought to take it outside the bounds of reasonableness, it would be sensible for there to be negotiation between the publisher and the person complaining. A failure or refusal to enter into such negotiation might, in a particular case, confirm an opinion that, on the whole, the letter or statement tendered was ‘reasonable’. Otherwise, all of the cards are stacked in favour of the publisher and against the person complaining. The purpose of the proviso is to afford the complainant a statutory means to secure the publication of a relevant contradiction or explanation. The purpose of the publication envisaged by the proviso is not to afford the complainant, or anyone else, the opportunity to insult the publisher, to extract an apology or to defame others. The ultimate purpose is to contribute to equalising the power to communicate with the audience which has already heard or seen matter considered to be defamatory where it is desired by the person affected to offer to the public other material in contradiction or explanation…”
“The notice or report must be of a genuinely official nature, and must be issued in such circumstances that it may fairly be regarded as issued for the information of the public. It is not, of course, for this court to assume to lay down rules for what is, and what is not, proper to be made the subject of a governmental or police notice or report. I see no reason for doubting that an authoritative announcement of an official character made or handed to members of the press for publication in their respective newspapers would, or at least could, constitute a notice or report issued for the information of the public, and if published in the form in which it was supplied would be published with the consent of the department, etc., supplying it. On the other hand, if the matter so supplied was such as to admit of a reasonable inference that it was mere gossip and not an official notice or report, or that an official report so supplied was not published in substantially the form in which it was issued, it would be competent to the tribunal of fact to find that the defence had not been made out…”
“A copy or a fair and accurate report or summary of a statement, notice, or other matter issued for the information of the public by or on behalf of the Government or any department or departmental officer, or any local authority or officer of the authority”. , and applied for summary judgment. The application was granted, and the claim dismissed. The Court was satisfied that the newspaper report was a fair and accurate report of the statement obtained from police (p.534). On the issue of whether the statement was of a “sufficiently official nature” to satisfy the requirement that it was “issued for the information of the public” – described as the “status requirement”
“(1) It is a defence to the publication of defamatory matter if the defendant proves that the matter was contained in-- (a) a public document or a fair copy of a public document, or (b) a fair summary of, or a fair extract from, a public document. … (4) In this section, ‘public document’ means -- … (d) any document issued by the government (including a local government) of a country, or by an officer, employee or agency of the government, for the information of the public …”
“44. This section creates a new defence of qualified privilege relating to peer-reviewed material in scientific or academic journals (whether published in electronic form or otherwise). The term ‘scientific journal’ would include medical and engineering journals. 45. Subsections (1) to (3) provide for the defence to apply where two conditions are met. These are condition 1: that the statement relates to a scientific or academic matter; and condition 2: that before the statement was published in the journal an independent review of the statement’s scientific or academic merit was carried out by the editor of the journal and one or more persons with expertise in the scientific or academic matter concerned. The requirements in condition 2 are intended to reflect the core aspects of a responsible peer-review process. Subsection (8) provides that the reference to ‘the editor of the journal’ is to be read, in the case of a journal with more than one editor, as a reference to the editor or editors who were responsible for deciding to publish the statement concerned. This may be relevant where a board of editors is responsible for decision-making. 46. Subsection (4) extends the protection offered by the defence to publications in the same journal of any assessment of the scientific or academic merit of a peer-reviewed statement, provided the assessment was written by one or more of the persons who carried out the independent review of the statement, and the assessment was written in the course of that review. This is intended to ensure that the privilege is available not only to the author of the peer-reviewed statement, but also to those who have conducted the independent review who will need to assess, for example, the papers originally submitted by the author and may need to comment. 47. Subsection (5) provides that the privilege given by the section to peer-reviewed statements and related assessments also extends to the publication of a fair and accurate copy of, extract from or summary of the statement or assessment concerned. 48. By subsection (6) the privilege given by the section is lost if the publication is shown to be made with malice. This reflects the condition attaching to other forms of qualified privilege…”
“It is not made clear what degree of expertise is required or how that will be judged. For example, if the statement complained of features in an article about the law of libel, will a person who has written on the law of tort but not defamation be possessed of the necessary expertise? In an appropriate case, would the court permit the claimant to introduce expert evidence for the purpose of challenging the alleged expertise of the reviewers?”
“The draft Bill goes some way towards tackling this problem by extending qualified privilege to include fair and accurate reports of what is said at a ‘scientific or academic conference’. We welcome this development, provided the conference is reputable. However, our inquiry revealed unanimous support for extending protection of qualified privilege to peer-reviewed articles published in scientific or academic journals, as recommended in 1975 by the Faulks Committee when the law of defamation was last reviewed comprehensively. Peer-reviewed articles are arguably the main platform for scientific and academic debate, and more reliable in their quality than conferences. Such articles may, in principle, be protected by other types of legal privilege, including qualified privilege and the so-called Reynolds defence, but the Reynolds defence in particular is often time consuming and costly to make out. In our view a proper peer review process should lead to the publication being treated as responsible and should have special protection in the public interest without the burden of having to prove ‘responsibility’ in every individual case. Scientists and academics must not be left in fear of being sued simply for doing their job. We recommend that a provision is added to the draft Bill extending qualified privilege to peer-reviewed articles in scientific or academic journals”. (emphasis added) (3) Lord McNally, in moving the Bill on the Government’s behalf during the debates in the House of Lords, said the following on15 January 2013 (HL Debate, col. GC238): “It is interesting that when the legislation was first put forward by my noble friend Lord Lester, he did not make any provision for the protection of scientific journals, but particular concerns were expressed about the impact of the threat of libel proceedings on scientific and academic debate. We therefore believe that the addition to the general protections offered by the Bill of a specific defence of peer-reviewed material is appropriate. Other aspects of the Bill and work associated with it, such as the serious harm test and actions on cost protection, will also help to support free speech in these areas. Let us be clear: right from the start, I wanted to provide protection for genuine academic and scientific debate. I have to say to my noble friend Lord Phillips that ‘academic and scientific’ is a term that is generally understood — it does not mean the Beano. People know one when they see one. Within that, there is also the important context that we are looking for genuine peer review, which, again, is understood. I worry, as I think the noble Lord, Lord Bew, does — I will also be interested in the response from the noble Lord, Lord Hunt, to the specific questions — that we must not push the envelope too far on this, otherwise we will run into some of the problems that the noble Lord, Lord Browne, raised. We are right to be cautious. As I say, the issue featured prominently in our discussions with the scientific community. We also held discussions with the editors of all the key journals to ensure that appropriate conditions were attached, so that the clause applied only where responsible peer-review process was used. We shared the relevant aspect of the clause with those editors to confirm that this was achieved. Amendment 31 would extend the defence to peer-reviewed material on, ‘a website edited and controlled by a chartered professional or learned body’. We are concerned that this would make the defence too widely available. We believe that it is important to ensure that only bona fide publications with appropriate procedures are given the protection of the new defence. That is why we have focused the clause on scientific and academic journals, where there is a well established process for peer review. I can confirm that the existing clause would cover peer-reviewed material that was published by such a journal in an electronic form. However, a potentially wide range of bodies may fall within the categories proposed by the noble Lord, and we are concerned that this would extend the defence into areas where peer review is not a common practice. That may lead to the defence being available in instances where it is more likely that the peer-review process will not have been applied sufficiently robustly”. (emphasis added) Ms Page KC argues that it would be extraordinary if Lord McNally had expressed himself in this way, particularly in the underlined passage, without making it clear that Clause 6(5) if enacted would make provision for a general privilege for the press and everyone else, if that is what the Government intended. (4) Save in relation to Lord Hunt’s Amendment 31 (which was withdrawn) and Amendment 35 (which was not moved), Clause 6 was not the subject of significant Parliamentary discussion and debate. It was enacted in the same terms as it entered the House of Commons, with only one exception: the insertion into Clause (which became s.6(1)) of the phrase “(whether published in electronic form or otherwise)”
“[47] It is vital that members of the scientific and academic communities can engage in vigorous and uninhibited debate provided they do so responsibly and honestly, since their work helps to shape every aspect of the world in which we live. This includes medical research into matters of the greatest public importance. Historic examples include the safety of smoking or the risks associated with a drug such as Thalidomide, where the truth emerged over time thanks to persistent and impartial research. A process of critical review is essential through which the work of one person, or group, is published and subsequently challenged by others. It is unavoidable that these efforts to uncover the truth and expand the limits of our understanding sometimes turn out to be wrong or to clash with the commercial and personal interests of other individuals and corporate organisations within society. For example, publishing research that reveals a particular product as unsafe or inefficient could seriously damage the business of its manufacturer, but may save lives. There is convincing evidence that defamation law is being used to silence responsible members of the medical and scientific community in order to protect products and profits. In particular, we were informed that 10% of all libel claims involve science and medicine, and that 80% of GPs feel inhibited in discussing medical treatments publicly due to fear of facing a claim. At a cultural and social level, it is also important for historians, geographers, political scientists and other academics similarly to be able to research and publish without undue fear of litigation. We took evidence from various individuals who have first-hand experience of the lengthy and costly trauma of being dragged through the courts. For most scientists and academics defending libel proceedings is unthinkable, with the effect that important issues are either not being discussed publicly or at all. [48] The draft Bill goes some way towards tackling this problem by extending qualified privilege to include fair and accurate reports of what is said at a ‘scientific or academic conference’. We welcome this development, provided the conference is reputable. However, our inquiry revealed unanimous support for extending protection of qualified privilege to peer-reviewed articles published in scientific or academic journals, as recommended in 1975 by the Faulks Committee when the law of defamation was last reviewed comprehensively. Peer-reviewed articles are arguably the main platform for scientific and academic debate, and more reliable in their quality than conferences. Such articles may, in principle, be protected by other types of legal privilege, including qualified privilege and the so-called Reynolds defence, but the Reynolds defence in particular is often time consuming and costly to make out. In our view a proper peer review process should lead to the publication being treated as responsible and should have special protection in the public interest without the burden of having to prove ‘responsibility’ in every individual case. Scientists and academics must not be left in fear of being sued simply for doing their job. We recommend that a provision is added to the draft Bill extending qualified privilege to peer-reviewed articles in scientific or academic journals…” (2) On29 February 2012 , the Ministry of Justice published the Government’s response to the Report of the Joint Committee (Cmnd. 8295). On the issue of peer-reviewed papers it included (at paragraph 48): “The draft Bill already provides for qualified privilege to be extended to fair and accurate reports of academic and scientific conferences. This was supported by the majority of consultation responses, and we will retain provisions on this in the substantive Bill. We are sympathetic to the need to provide clear protection for peer-reviewed articles published in scientific and academic journals and will consider further whether this can best be achieved through qualified privilege or other means, and how key elements of the peer-review process can be defined to ensure that the scope of any provision is clear”. (3) The Defamation Bill was introduced to the House of Commons and received its first reading on10 May 2012 . The Bill included a new clause 6 (“Peer-reviewed statement in scientific or academic journal etc”.), which had not been in the Draft Defamation Bill presented with the Consultation Paper in March 2011. Clause 6 of the Bill, as presented to Parliament, was in substantially the same terms of section 6 of the Act as it was ultimately enacted. The only change was the addition of the words “(whether published in electronic form or otherwise)” into s.6(1). (4) On12 June 2012 , the then Lord Chancellor, Kenneth Clarke, introduced the Defamation Bill, on behalf of the Government, during its second reading in the House of Commons (HC Vol. 546 cols. 177-267). He said (at col. 182): “I am confident that everybody in this Chamber agrees that freedom of expression is the cornerstone of our democracy. In an open society, people should be at liberty to debate a subject without fear or favour, whether the matter be political, scientific, academic or anything else. That is how power is held to account, abuses of authority are uncovered and truth is advanced. But freedom of speech does not mean that people should be able to ride roughshod over the reputations of others without regard to the facts. Life and career can be destroyed by false allegations that go unanswered. The issue for our defamation laws is ultimately one of striking the right balance between protection of freedom of expression on the one hand and protection of reputation on the other. I share the mounting concern of recent years that our defamation laws are becoming out of date, costly and over-complicated, and that they are at risk of damaging freedom of speech without affording proper protection. No one can be satisfied with a situation where the threat of lengthy and costly proceedings has sometimes been used to frustrate robust scientific and academic debate, to impede responsible investigative journalism and to undermine the good work undertaken by many non-governmental organisations… In a further important step forward for the protection of scientists and academics, clause 6 creates a defence of qualified privilege for peer-reviewed material in scientific and academic journals, as recommended by the Joint Committee on the draft Bill. The clause defines key elements of the peer-review process to ensure that publications with appropriate procedures will now be given the protection of this new defence”
“… we believe that extending the clause 6 protection is important in order to help encourage robust and open scientific and academic debate, and I, too, acknowledge the principled stand and ongoing participation of Dr Simon Singh in this area. In drafting the clause, we have given careful consideration to defining key elements of the peer-review process to ensure that the scope of the provisions is clear and appropriate, and we are satisfied that it is”
“It is nice to see that there is clear consensus on support for the clause, which creates a new defence of qualified privilege for peer-reviewed material in scientific or academic journals. A core concern underlying our commitment to reforming the law is to protect scientific and academic debate from the threat of unjustified libel proceedings. Clause 6 is one of a number of measures in the Bill that are intended to encourage open and robust scientific and academic debate. As hon. Members have said, it responds to a recommendation made by the Joint Committee on the draft Bill. Subsections (1) to (3) provide for the defence to apply where certain key elements that relate to the peer review process are met. Those are that the statement concerned ’relates to a scientific or academic matter’ and that before it was published ’an independent review of the statement’s scientific or academic merit was carried out by the editor of the journal, and one or more persons with expertise’ in the matter concerned. Subsection (8) clarifies that where a journal has more than one editor, the reference is to the editor or editors who were responsible for the decision to publish the statement concerned. Those requirements stem from discussions we have had with editors of major journals, and they are intended to reflect the core aspects of a responsible peer-review process to ensure that only publications with appropriate procedures are given the protection of the new defence. Subsection (4) ensures that the protection offered by the defence is available not only to the author of the peer-reviewed statement but to those who have conducted the independent review of its scientific or academic merit. We consider it fair that reviewers participating in the process, who may need to assess the papers submitted by the author and comment on them, and whose assessments are published in the journal, should also be protected. Subsection (5) extends qualified privilege to fair and accurate copies, extracts and summaries of the peer-reviewed statement. Subsections (6) and (7) contain provisions that apply to qualified privilege in other contexts. They establish that privilege is lost if publication is shown to be made with malice, and that a person who publishes material in a scientific or academic journal is not prevented from relying on other forms of privilege such as that conferred by clause 7(9) on fair and accurate reports of proceedings at a scientific or academic conference. The hon. Member for Stoke-on-Trent South asked whether the peer review defence would have been available in the Simon Singh case, and the answer is no. Simon Singh might, however, have been able to benefit from the other changes we are making on issues such as serious harm and honest opinion”
“The Bill reflects our view that the law is out of kilter, and that our defamation regime is out of date, costly and over-complicated. It needs urgent reform so as to offer more effective protection for freedom of speech and to stop the threat of long and costly libel proceedings being used to stifle responsible investigative reporting and scientific and academic debate… In addition to [several] general measures, the Bill takes specific steps to encourage robust scientific and academic debate by creating a new defence against libel for peer-reviewed material in scientific and academic journals, and by extending qualified privilege to reports of scientific and academic conferences. Given the work that my right hon. Friend the Minister for Universities and Science is doing to promote science in this country, the more we can send messages that we value scientific research in this country, the better”. (7) On15 January 2013 , the third day of Committee Stage in the House of Lords, peers considered an amendment to Clause 6(1), proposed by Lord Hunt, to insert, after “journal”, the words “or on a website edited and controlled by a chartered professional or learned body (a ‘recognised website’)”
“The law quite rightly requires that questions of dishonesty be approached more rigorously than other questions of fault. The burden of proof remains the civil burden—the balance of probabilities—but the assessment of the evidence has to take account of the seriousness of the allegations and, if that be the case, any unlikelihood that the person accused of dishonesty would have acted in that way. Dishonesty is not to be inferred from evidence which is equally consistent with mere negligence.”
“The public interest that the law should provide an effective means whereby a man can vindicate his reputation against calumny has nevertheless to be accommodated to the competing public interest in permitting men to communicate frankly and freely with one another about matters in respect of which the law recognises that they have a duty to perform or an interest to protect in doing so. What is published in good faith on matters of these kinds is published on a privileged occasion. It is not actionable even though it be defamatory and turns out to be untrue. With some exceptions which are irrelevant to the instant appeal, the privilege is not absolute but qualified. It is lost if the occasion which gives rise to it is misused. For in all cases of qualified privilege there is some special reason of public policy why the law accords immunity from suit - the existence of some public or private duty, whether legal or moral, on the part of the maker of the defamatory statement which justifies his communicating it or of some interest of his own which he is entitled to protect by doing so. If he uses the occasion for some other reason he loses the protection of the privilege. So, the motive with which the defendant on a privileged occasion made a statement defamatory of the plaintiff becomes crucial. The protection might, however, be illusory if the onus lay on him to prove that he was actuated solely by a sense of the relevant duty or a desire to protect the relevant interest. So he is entitled to be protected by the privilege unless some other dominant and improper motive on his part is proved. ‘Express malice’ is the term of art descriptive of such a motive. Broadly speaking, it means malice in the popular sense of a desire to injure the person who is defamed and this is generally the motive which the plaintiff sets out to prove. But to destroy the privilege the desire to injure must be the dominant motive for the defamatory publication; knowledge that it will have that effect is not enough if the defendant is nevertheless acting in accordance with a sense of duty or in bona fide protection of his own legitimate interests. The motive with which a person published defamatory matter can only be inferred from what he did or said or knew. If it be proved that he did not believe that what he published was true this is generally conclusive evidence of express malice, for no sense of duty or desire to protect his own legitimate interests can justify a man in telling deliberate and injurious falsehoods about another, save in the exceptional case where a person may be under a duty to pass on, without endorsing, defamatory reports made by some other person. Apart from those exceptional cases, what is required on the part of the defamer to entitle him to the protection of the privilege is positive belief in the truth of what he published or, as it is generally though tautologously termed, ‘honest belief.’ If he publishes untrue defamatory matter recklessly, without considering or caring whether it be true or not, he is in this, as in other branches of the law, treated as if he knew it to be false. But indifference to the truth of what he publishes is not to be equated with carelessness, impulsiveness or irrationality in arriving at a positive belief that it is true. The freedom of speech protected by the law of qualified privilege may be availed of by all sorts and conditions of men. In affording to them immunity from suit if they have acted in good faith in compliance with a legal or moral duty or in protection of a legitimate interest the law must take them as it finds them. In ordinary life it is rare indeed for people to form their beliefs by a process of logical deduction from facts ascertained by a rigorous search for all available evidence and a judicious assessment of its probative value. In greater or in less degree according to their temperaments, their training, their intelligence, they are swayed by prejudice, rely on intuition instead of reasoning, leap to conclusions on inadequate evidence and fail to recognise the cogency of material which might cast doubt on the validity of the conclusions they reach. But despite the imperfection of the mental process by which the belief is arrived at it may still be ‘honest,’ that is, a positive belief that the conclusions they have reached are true. The law demands no more. Even a positive belief in the truth of what is published on a privileged occasion - which is presumed unless the contrary is proved - may not be sufficient to negative express malice if it can be proved that the defendant misused the occasion for some purpose other than that for which the privilege is accorded by the law. The commonest case is where the dominant motive which actuates the defendant is not a desire to perform the relevant duty or to protect the relevant interest, but to give vent to his personal spite or ill will towards the person he defames. If this be proved, then even positive belief in the truth of what is published will not enable the defamer to avail himself of the protection of the privilege to which he would otherwise have been entitled. There may be instances of improper motives which destroy the privilege apart from personal spite. A defendant’s dominant motive may have been to obtain some private advantage unconnected with the duty or the interest which constitutes the reason for the privilege. If so, he loses the benefit of the privilege despite his positive belief that what he said or wrote was true. Judges and juries should, however, be very slow to draw the inference that a defendant was so far actuated by improper motives as to deprive him of the protection of the privilege unless they are satisfied that he did not believe that what he said or wrote was true or that he was indifferent to its truth or falsity. The motives with which human beings act are mixed. They find it difficult to hate the sin but love the sinner. Qualified privilege would be illusory, and the public interest that it is meant to serve defeated, if the protection which it affords were lost merely because a person, although acting in compliance with a duty or in protection of a legitimate interest, disliked the person whom he defamed or was indignant at what he believed to be that person’s conduct and welcomed the opportunity of exposing it. It is only where his desire to comply with the relevant duty or to protect the relevant interest plays no significant part in his motives for publishing what he believes to be true that ‘express malice’ can properly be found.”
“If the occasion is privileged it is so for some reason, and the defendant is only entitled to the protection of the privilege if he uses the occasion for that reason. He is not entitled to the protection if he uses the occasion for some indirect and wrong motive. If he uses the occasion to gratify his anger or his malice, he uses the occasion not for the reason which makes the occasion privileged, but for an indirect and wrong motive. If the indirect and wrong motive suggested to take the defamatory matter out of the privilege is malice, then there are certain tests of malice. Malice does not mean malice in law, a term in pleading, but actual malice, that which is popularly called malice. If a man is proved to have stated that which he knew to be false, no one need inquire further.”
“The statutory privileges… relied upon by [the defendant] are plainly accorded for occasions where the publisher need not be acting out of any duty or interest, and where the publisher is not required to have any belief in the truth or falsehood of the document of which he is publishing an extract… Lord Diplock referred in passing at 150 to ‘the exceptional case where a person may be under a duty to pass on, without endorsing, defamatory reports made by some other person’. But he did not refer to the occasions which are the norm, not the exception, in statutory privilege, where the publisher (being under not duty) chooses to pass on, without endorsing, defamatory statements in which he has no belief. In statutory privileges it is the public interest that provides the basis of the legislative purpose, not the interests of the publisher, still less any duty of the publisher”
“If the tests in the Schedule to the 1996 Act (fairness and accuracy) and in s.15(3) (public concern and public benefit) were satisfied in this case, contrary to what I have decided above, then malice could be established in principle by proof that ANL knew that the claim was disputed but knowingly published the false statement that it was not disputed, or if ANL knew that the form in which it reported the extract from the particulars of claim … was misleading or unfair.”
“… The place and meaning of malice in the law of qualified privilege could, it seems to me, be the subject of further argument in the light of Article 10…”
“The test is not the same as but is influenced by the test for whether two publications are to be treated as one for the purposes of defamation.”
“Whether readers follow links provided like this is influenced by a number of factors, including: (1) their familiarity with the story or subject matter and whether they consider they already know [what] they are offered by way of further reading; (2) their level of interest in the particular article and whether that drives them to wish to learn more; (3) particular directions given to read other material in the article; (4) if the reader considers that he or she cannot understand what is being said without clicking through to the hyperlink. It might be reasonable to attribute items (3) and (4) to the hypothetical ordinary, reasonable reader, but (1) and (2) will vary reader by reader.”
“… where the [claimant] submits that more than one publication is to be taken into account to found the defamatory imputation, I conclude that the test to be applied is whether, having regard to all of the circumstances, it is to be inferred that hypothetical ordinary reasonable reader of the material complained of will also have read, or have in mind, the other material which is relied upon as context. For that to be possible, there must be a sufficient nexus, connection or association between the publications, which could include a reference or hyperlink or the publications being part of for example, a Twitter conversation, or a series or sequence of material.”
“There was no reasonable basis for such a belief. Rather, objectively speaking, Mr Calman could only have reasonably believed that publication was contrary to the public interest. Mr Calman’s ‘investigation’ and the journalism that it produced were not of a quality or standard such as to warrant protection under s.4, making all due allowances for editorial judgment, especially in circumstances where the material in question was being published to the [newspaper’s] extremely large readership. This was not an open-minded investigation in the conventional sense of having no fixed conclusion (see Packham)… but a quest for material to support as strongly as possible Mr Calman’s takedown, where the ultimate outcome – the ‘utter discrediting’ of the Claimants, as Ms Page KC put it to Mr Calman in cross-examination… was predetermined”
“Unbiased groups of scientific investigators analysing the same data can reach very different conclusions”
“High LDL-C is inversely associated with mortality in most people over 60 years. This finding is inconsistent with the cholesterol hypothesis (i.e. that cholesterol, particularly LDL-C, is inherently atherogenic).”
“[Professor Collins] emphasised the seriousness of his concerns, describing: ‘the need to rectify the harm that has been caused –perhaps resulting in large numbers of unnecessary deaths, heart attacks and strokes among patients at elevated risk – by misleading doctors and the public with gross over-estimates of the rates of side-effects with statins.’”
“The authors withdraw this statement. Although it was based on statements in the referenced observational study by Zhang and colleagues, that ‘the rate of reported statin-related events to statins was nearly 18%’, the article did not reflect necessary caveats and did not take sufficient account of the uncontrolled nature of the study.”
“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.”
“At a more fundamental level, who should decide when such questions are too dangerous to ask? Certainly not those who have a vested interest in the debate being shut down. Rory Collins, head of the Cholesterol Treatment Trialists’ (CTT) Collaboration, continues to call for the retraction of two [2013 BMJ Articles] that disputed the use of statins in low risk people. His call comes despite an independent expert panel set up by The BMJ and, subsequently, the Committee on Publication Ethics (COPE) concluding that The BMJ had acted appropriately in its handling of the papers. This week we publish documents that serve to correct Richard Horton’s comments in the Lancet, in which he wrongly stated that COPE had ‘declined to act’ on Collins’s concerns. Independent third party scrutiny of the statins trial data remains an essential next step if this increasingly bitter and unproductive dispute is to be resolved. I have now written to England’s chief medical officer, Sally Davies, asking her to call for and fund an independent review of the evidence on statins. As Krumholz concludes, sharing the individual patient level data from the statins trials would send ‘a strong message that no single person or group should have exclusive access to data’ that are so important for public health.”
“So, they have written a paper outlining all of the issues of adverse effects and serious adverse effects - and yet they do not have the data. So, how did they manage that?”
“Statins: we need an independent review” (see [213] above). In her article, Dr Godlee, the editor of The BMJ, had called for “independent third party scrutiny of the statins trial data” which she said “remains an essential next step” in the resolution of an “increasingly bitter and unproductive dispute [over statins]”
“all… owe some, if not a large part of their status to their stance as statin deniers and have profited from it” (Text Box [I]). Again, I accept, that if s/he paused to think deeply about the questions of “profit”, “status” and the motivation of the Claimants raised in the Articles, a reader might conclude that it was possible to be motivated by money and status, and yet still be honest, but mistaken. However, this is the sort of analysis that would either be the product of significant analysis, or someone at the reader’s elbow challenging them that there might be a charge other than dishonesty that was being alleged against the Claimants. Neither is the proper test of the natural and ordinary meaning. Put shortly, the Articles alleged that the Claimants had a venal motive for their lies. This was one of the aspects that made them so deserving of contempt, and a “special place in hell”. (5) Finally, the overall presentation of the Claimants’ statements in the Articles does nothing to detract from the dishonesty meaning. If the Claimants had been presented as honest, but mistaken critics of statins, that would have led to the Articles bearing a different meaning. But they were not. In the four instances of “Fake News”, the Claimants’ statements were presented, and then discredited by the ‘trustworthy’ experts. No independent support for the Claimants’ statements was provided for the readers to consider and take into account (and which might have caused them to conclude that the Claimants were honest, but mistaken, rather than dishonest). Perhaps most significantly on this issue, in the Editorial ([12]), readers saw the comparison drawn between honest scientists, like Barry Marshall, who bravely (and, in context, honestly) challenged, and stood up to, medical orthodoxy, and the dishonest ‘statin deniers’ who “whip up controversy, peddle conspiracy theories, or sell diet books” and “peddle… a particularly insidious type of fake news, apparently from a respectable, credible source, but laced with misinformation”
“(1) each Claimant had made false public statements, knowing that they were false, the effect of which was to cause doubt as to whether statins were effective (or otherwise undermine public confidence in statins) and thereby led thousands of patients, like Colin, to stop taking prescribed statin medication which exposed them to a serious risk of a heart attack resulting in illness, disability or death”
‘Medical evidence shows that statins save lives. ‘Needlessly risking people’s health by spreading reckless and ignorant misinformation claiming otherwise is completely unjustified’. [3] About eight million Britons take statins, which can substantially reduce the risk of having a heart attack or stroke by lowering cholesterol – a fatty substance that contributes to the blocking of arteries – in the blood. [4] However, some medics dispute the benefits and a few wrongly assert they can cause serious and widespread damage to health. Inaccurate claims by ‘statin deniers’ include that high cholesterol is not linked to an increase risk of cardiovascular disease. These rely on small, observational studies, rather than ‘gold standard’ randomised controlled trials over many years that show statins do cut death from heart attacks. [Logo of The Mail on Sunday in a circle with the words] FIGHT FAKE HEALTH NEWS [5] The Health Secretary said: ‘These kind of pernicious lies have no place in our NHS and I welcome The Mail on Sunday’s work to shine a light on the scale of the problem. As part of our Long Term Plan for the NHS, we want to save thousands more lives from preventable conditions such as heart disease and strokes. ‘Medicines such as statins can and do play a huge role in keeping people at risk of cardiovascular disease healthy. I strongly urge anyone who is prescribed them to listen to the advice of their doctors and nurses.’ [6] Doctors can prescribe statins if a patient is assessed as having a ten per cent chance or greater of having a cardiovascular ‘event’ over the next decade. However, a recent analysis by the London School of Hygiene & Tropical Medicine estimated that scare stories may have resulted in 200,000 patients who need the drug giving it up in a period of just six months. [7] Dr Matt Kearney, NHS England’s National Clinical Director for Cardiovascular Disease Prevention, said: ‘There is overwhelming evidence that statins prevent heart attacks and strokes and that they are safe. But if patients get worried by false, alarmist or misleading reports they see on social media and in the press and, as a result, decide not to take these life-saving medicines, they can end up making the wrong decision about how to stay well, and cause themselves real harm’. [8] The Mail on Sunday campaign comes amid growing concern about the erosion of trust in mainstream evidence-based medicines caused by ‘fake news’ on the internet. On Friday, NHS England Chief Executive Simon Stevens warned that ‘vaccine deniers’ who went online to spout ‘fake messages’ were making it harder for doctors to ‘win the public argument’ on vaccination. [9] He told a meeting at the Nuffield Trust think-tank: ‘The vaccination deniers are getting some traction. Although nine in ten parents support vaccination, half of them say they have seen fake messages about vaccination on social media.’ [text in a block at the foot of the News Article] ‘EXPERTS’
‘The stories contain a grain of truth, mixed with speculation and opinion. [12] ‘It makes it very difficult for the public to know what the facts are, or whom to trust. Of course, we should debate the evidence, but all they have done is confuse people about the benefits of statins, which means those who really need them might stop taking them’. [13] 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’. [14] 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 – and thousands of heart attacks and strokes may occur as a result. [15] Last night Health Secretary Matt Hancock voiced his concern about the ‘pernicious lies’ being circulated and added: ‘Statins play a huge role in keeping people at risk of cardiovascular disease healthy. Risking people’s health by spreading reckless and ignorant misinformation claiming otherwise is completely unjustifiable’. [16] Professor Sir Rory Collins, the British scientist behind pivotal research into statins, says the potential consequences far outweigh that of the infamous MMR vaccine scandal, in which disgraced paediatrician Andrew Wakefield fabricated evidence to support his idea that the jab triggered autism in infants, leading to a decline in vaccination uptake and the resurgence of measles. The suggestion is that the statin deniers are simply wrong rather than dishonest, but Prof Collins says: ‘In terms of death and disability that could have been prevented, this could be far worse than we saw with MMR’. [17] So what of the claims themselves – how do they stand up to scrutiny. To find out, this newspaper examined the most commonly circulated fake news on statins. [18] And to test it, we enlisted the help of researchers who have devoted their lives to understanding how to treat heart disease, and who have produced the highest quality scientific evidence on the subject. Read on… and decide for yourself who YOU should entrust your health to. FAKE NEWS: HAVING HIGH CHOLESTEROL IS HARMLESS [19] FIRST, a few facts about what is known about heart disease. As we age, our heart attack risk increases and one of the key factors is levels of cholesterol – a type of waxy fat, mostly produced by the liver – in the blood. The terms ‘bad cholesterol’ and ‘good cholesterol’ are often used, but today doctors are mainly concerned with (LDL), ‘balls’ of fat and protein which carry cholesterol from the liver into the bloodstream. [20] A combination of genetic predisposition, poor diet and lifestyle factors can mean that the body produces too much LDL, which contributes to a process known as atherosclerosis. [21] This begins when the walls of the arteries, called the endothelium, become inflamed. High blood pressure, raised blood sugar levels, smoking, genetic predisposition and LDL itself all contribute to this process. [22] Once the endothelium is damaged, LDL begins to penetrate and build up within the artery walls where it hardens and forms deposits called plaques. The endothelium can then rupture in places, exposing the fatty plaque contents to the blood, which forms a clot to seal the split as part of the body’s natural healing mechanism. [23] It is the narrowings caused by this process that hinders the circulation and can block blood flow to the heart or brain – with potentially catastrophic consequences. [24] But statins deniers still insist LDL is not a problem. [25] One of the key figures, Dr Malcolm Kendrick, a GP from Cheshire, warns in his latest book: ‘People are being conned. The way to avoid heart disease… has nothing to do with lowering cholesterol’. [26] In 2016 he appeared on BBC News promoting research he had published by the British Medical Journal. He said: ‘We found that if your bad cholesterol was higher you were no more likely to die of heart disease or strokes’. [27] Another prolific denier, Dr Zoë Harcombe – who admits she is an academic, not a medical doctor – author of one of the bestselling diet books of 2019, recently blogged: ‘High cholesterol is not even associated with high heart disease, let alone a cause’. [28] So are they right? No says Prof Collins, who points to one unquestionable area of proof against this argument: genetics. [29] One inherited condition, familial hypercholesterolaemia, causes sky-high cholesterol levels, even in children. Left untreated, it can kill sufferers in their 20s or 30s. [30] But with high-doses of statins many can and do survive into old age. In recent years further DNA faults have been identified that also cause modest LDL increases, and raised heart risk. Those with genetically low LDL levels have a very low risk of heart disease. [31] Another thing deniers seem to rely on is the perception that all scientific studies are equally authoritative, when in fact they aren’t. There are observational studies, where researchers follow volunteers over time in order to observe the relationship between a certain risk factor or treatment and their chances of developing an illness. [32] This kind of research can reveal a link, or association, for example, that among people with a high LDL level, there are more cases of heart disease than in those with a lower LDL level. [33] But such studies cannot determine cause and effect: it is impossible to know whether it is the LDL or other things in that person’s life causing the heart problems. [34] The most reliable data about the effects of lowering LDL comes from randomised double blind clinical trials. In these, patients are randomly split into groups. Some receive a dummy ‘placebo’ pill. No one, not even the researchers, know which is which – and all patients are otherwise treated in exactly the same way. This proves is the drug works, and no other factor could be of influence. [35] Dr Kendrick admitted that his study was observational but said: ‘The proof of the link between smoking and lung cancer was based on observational studies. They have value’. [36] And this may be the case. But Professor Colin Baigent, an epidemiologist at the University of Oxford, who is also involved in major statins trials, explains that it is misleading to claim observational studies on statins refute what has been proven in clinical trials, and it’s not comparing like for like. He said: ‘We know statins work because there have been numerous, very large randomised clinical trials that prove that lowering LDL with these drugs reduces the risk of heart attacks and strokes’. [37] Prof Collins says some observational studies have found low LDL is associated with higher death rates in older people, but of course, have not proved cause and effect. ‘It’s known that in older patients, other illnesses such as cancer can cause low LDL,’ he says. Statins trials also show benefits in the elderly. FAKE NEWS: STATINS DON’
‘The 2015 study Kendrick mentions only looked at life extension over the trial period of a few years. Statins are lifelong drugs, and the extension of life over a lifetime will be very much greater. And the important thing is statins extend healthy life. They avoid both disabling events like heart attacks and strokes. Simply focusing attention on extra duration of life is to ignore the fact that these drugs reduce disability’. [40] Professor Liam Smeeth of the London School of Hygiene and Tropical Medicine (LSHTM) explains: ‘What matters is your heart attack risk when treatment starts. If you have a 30 per cent risk then statins could reduce that risk by at least a quarter.’ [41] For anyone in any doubt, UK heart disease and stroke deaths plummeted by two-thirds between 1980 and 2013, partly due to fewer smokers and better emergency care, but also because of wider statin use. [42] Prof Samani says: ‘Heart attacks used to kill men in their 50s and even 40s, but thanks in part to drug therapies people are living longer, healthier lives’. [43] However, Dr Kendrick says: ‘My paper (which linked high LDL with a longer life) was the most read paper in the BMJ Open website for five months in a row and provides the rationale for re-evaluation of cholesterol-lowering guidelines’. [44] Dr Harcombe said: “I have examined the entire data provided by the World Health Organisation and found that higher cholesterol is associated with lower deaths, from heart disease and all-causes, in men and women, for all 192 countries in the world. [45] ‘My PhD was an examination of the diet (cholesterol) heart hypothesis. I have studied this topic at the highest level for several years and I am entitled, if not obliged, to share what I have found’
‘Side effects of these drugs have not been properly investigated. Patients are guinea pigs and they don’t even know it’. [52] There’s no doubt some people feel rotten on statins. But the deniers are vastly overstating their case. [53] Clinical trials show three serious side effects: on average, over a year of treatment, in every 10,000 patients on statins, one suffers myopathy, a potentially serious muscle weakening condition, ten to 20 develop diabetes, with those who are pre-diabetic being ‘pushed over the edge’, and one or two may suffer a brain bleed or haemorrhagic stroke. [54] Prof Baigent explains: ‘In clinical trials we see these adverse effects in far less than one per cent of patients’. [55] And Professor Peter Sever, an expert in pharmacology at Imperial College London who conducted one of the largest-ever studies into statins, suggests that the claims and counter-claims have left some patients incredibly … TURN TO PAGE 50 [pages 48-49 were illustrated with three large photographs of the Claimants and Dr Malhotra with the following captions:] DENIER ONE ‘Patients are being conned into taking statins’
‘We believe this is because people now worry so much about these side effects that all ill health is blamed on them.’
‘When patients suffer side effects we take it seriously but these symptoms can be caused by many other things, so it can be difficult to tell the cause. We may temporarily stop statins for a while to see if the problems go away. If they don’t we know it’s not the statins. If they do, we can try the same or another statin’
‘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’
‘I believe people are being conned, deliberately misled. All industry-funded sturdies were positive. This is either a remarkable coincidence or something else. [61] In a newsletter Dr Harcombe calls cardiologists, researchers and bodies involved in heart research ‘statin pushers’ – echoing the term drug pusher. Her inflammatory accusation, shared by the other deniers, is that statin researchers have received payments of around£286 million from drug manufacturers. She added: ‘It would be naïve not to think that sums such as£268 million from pharmaceutical companies encourage recipients to aggressively encourage people to take those drugs’. [62] But Prof Collins says there is a simple explanation for the ‘hidden data’ – they did not have it. ‘In 1995 we began gathering results from research groups who conducted major trials on statins which we added to our own data. [63] ‘We requested information on heart attacks and strokes, deaths from all causes and serious adverse events like cancer. We did not seek data on any other side effects and have publicly stated this. The lie just seems to be repeated, that we held data on adverse events and have not made if available’. [64] To put an end to this, Prof Collins and Prof Baigent have now requested every single adverse event in all the major studies and plan to publish the first analyses of these data later this year. [65] Of conflicts of interest, Prof Baigent added: ‘We have a long-standing policy of not accepting any personal payment from the pharma industry. Grants have been provided to the University of Oxford from drug companies but our salaries don’t depend on that money. [66] ‘Our trial of niacin, another drug to treat high levels of fat in the blood, led to a billion dollar a year drug being withdrawn from the European market, and warnings being added in the US. The results fall where they will’. [67] Prof Samani adds: ‘I’m a cardiologist, not involved in trials. I look after patients with heart conditions. I’d just like to see fewer people get ill and die’
‘We regularly see patients who, like Colin, have stopped taking statins because they believe the myth that they don’t do any good. In fact, he’s one of the lucky ones. He’s alive. [9] ‘There will be numerous reasons his heart disease progressed so far, but one of the factors will be because he stopped taking statins’. [10] Colin added: ‘I was a fool to stop taking the medication. Who cares whether or not someone is making money from statins. If I had carried on taking them, I might not be where I am now’. [11] To paraphrase Donald Tusk, there is a special place in hell for the statins deniers who continue to fuel public confusion and a vague perception that the drugs, as Colin said, ‘don’t really work’. [12] OK, I don’t actually believe in hell. Or Donald Tusk, much, for that matter. But they need to realise that the ultimate fall out from high-risk patients, such as Colin, stopping proven treatment will be illness, disability and death. Debate should – must – be at the heart of science. Just because someone has been awarded the title professor doesn’t make them right. And some of our greatest medical discoveries have come from so-called mavericks who ignored the orthodoxies. For decades, doctors believed stomach ulcers were caused by stress and there was no cure. It was only when Australian researcher Barry Marshall willingly swallowed H Pilori bacteria in an attempt to prove his thesis, that it was the infection that caused the ulcer, that the truth emerged – and a simply course of antibiotics is now offered as a solution. ‘Everyone was against me, but I knew I was right,’ he famously said. [13] But what he didn’t do was whop up controversy, peddle conspiracy theories, or sell diet books. For we should make no mistake: the statins deniers are no Barry Marshalls. [14] The trio mentioned in our piece aren’t the only ones. There is Dr John Abramson at Harvard, author of the misleading ‘20 per cent side effect’
‘You’re trying to bully me into silence for blogging about conflicts of interest.’
‘Only a third of the 5.5 million over 75s in the UK take statins and up to 8,000 deaths per year could be prevented if all took them.’ - This is false. It relies upon evidence in the over 75s for both deaths and primary prevention (people who do not already have heart disease) and neither was found. - Figure 5 in The Lancet paper confirmed that the Rate Ratio (RR) for vascular deaths for over 75s was not statistically significant. Nor was it for those aged 70-75 for that matter. Even with the attempt to achieve a significant result, by excluding trials that failed to show benefit of statins, the RR for vascular deaths for over 75s was not statistically significant. - Figure 4 in The Lancet paper confirmed that the RR for major vascular events for over 75s without vascular disease was not statistically significant. Nor was it for those aged 70-75 for that matter. - This article was reported worldwide as ‘statins can save thousands of lives in the over 75s’
“But scientists said up to 8,000 lives could be saved annually in the UK alone if everyone over the age of 75 received statin therapy”. (The Express) “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”. (The Times) “Researchers said up to 8,000 deaths a year could be prevented if GPs simply prescribed drugs costing pennies a day”. (The Telegraph) (Ref 6). “Up to 8,000 pensioners a year are needlessly dying of heart disease because they are not being given statins, leading experts warn”. (The Daily Mail) (Ref 7). The 8,000 lives saved claim came from a press conference, which was held on January 30th to launch the paper. The press conference was reported in a BMJ article, which quoted Colin Baigent as saying “Only a third of the 5.5 million over 75s in the UK take statins and up to 8000 deaths per year could be prevented if all took them” (Ref 8). The problem with the 8,000 lives saved/deaths prevented claim is that it cannot be supported from evidence in the paper. The study The study published on 1st February was a meta-analysis of trials for which the CTSU holds data. The objective of the study was set out in the introduction: “We aimed to do a meta-analysis of data from all large statin trials to compare the effects of statin therapy at different ages and explore the effects of statin therapy among older individuals”
“High LDL-C is inversely associated with mortality in most people over 60 years”. i.e. high LDL-cholesterol is associated with lower deaths in most people over 60. I also knew to doubt the “lives saved” claim because statin patient leaflets caution against statin use in the over 70s. Here’s an extract from the Lipitor leaflet (the most prescribed statin) (Ref 11): [figure shown of “Warnings and precautions: Talk to your doctor, pharmacist of nurse before taking Lipitor - … if you are older than 70 years”] What about events? Even if the death claims are lies, what about the claimed reduction in events? The newspapers reported that, “for every 10,000 people aged 78, who take statins, but have no history of cardiovascular problems, 80 heart attacks or strokes would be prevented every year”
“Overall, 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”. - Figure 2 reported major vascular events by age and by type of trial (heart failure trials vs. dialysis trials vs. other trials). - Figure 3 reported major vascular events by age and by type of event (coronary event, stroke etc). - Figure 4 reported major vascular events by age and by previous vascular disease. There was no statistically significant difference between the statin group and the control group in people over 75 (or in the 70-75 age group). Benefit in those who have “no history of cardiovascular problems” cannot be claimed, therefore. Serious Adverse Effects Notwithstanding that no benefit can be claimed for those without previous vascular disease – and hence there will not be 80 fewer events per 10,000 78-year olds given statins – there will be serious adverse events in those people if they take statins. The Number Needed to Treat (NNT) is the important measure to examine. The web site for this is www.thennt.com Frustratingly, these numbers seem to change every time I look at the page (I suspect that there is intense pressure from drug companies for these figures to be ‘re-visited’). Currently, the NNT numbers advise that 1 in 10 people who take statins without known heart disease will be harmed by muscle damage and 1 in 50 will be harmed by developing (type 2) diabetes (Ref 13). So, for every 10,000 people given statins, 1,000 are likely to develop muscle damage and 200 are likely to develop (type 2) diabetes. For no benefit in heart disease. The Daily Mail article reported Colin Baigent as having said that “a number of misleading studies – which he branded ‘fake news’ – had created confusion over the effectiveness and side-effects of statins among doctors and patients”
‘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.’
“What about other events, what happened to them? Were they also reduced, did they say the same, or did they go up?”
‘In the two trials where serious adverse events are reported, the 1.8% absolute reduction in myocardial infarction and stroke should be reflected by a similar absolute reduction in total serious adverse events; myocardial infarction and stroke are, by definition, serious adverse events. However, this is not the case; serious adverse events are similar in the statin group, 44.2%, and the control group, 43.9%. This is consistent with the possibility that unrecognized serious adverse events are increased by statin therapy and that the magnitude of the increase is similar to the magnitude of the reduction in cardiovascular serious adverse events in these populations. This hypothesis needs to be tested by analysis of total serious adverse event data in both past and future statin trials. Serious adverse event data is available to trial authors, drug companies and drug regulators. The other measure of overall impact, total mortality, is available in all five trials and is not reduced by statin therapy.’ 3 What does this mean in reality? Well, gathering it all together. Statins (in the over 75s) do not reduce mortality. They do not prevent fatal Mis and strokes. Whilst they reduce serious cardiac events, previously published results demonstrate they do not reduce total serious adverse events. Which means that they are, wait for it, absolutely and completely useless. Two plus two does equal four. Always bear that fact in mind. 1: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)31942-1/fulltext 2: https://www.heart.org/en/news/2019/01/28/medical-experts-sound-the-alarm-on-medical-misinformation 3: https://www.ti.ubc.ca/pages/letter48.htm (C). The First Claimant’s Blog entry of11 February 2019 titled “Why cholesterol can’t cause heart disease” (see judgment [82]) [omitting some tables and diagrams] The more you examine the cholesterol-heart hypothesis, the more it doesn’t make sense. This week’s note has been inspired by three things that I read last week. The first was the Appendix to last week’s statin paper in the Lancet (Ref 1) [The Lancet 2019 Study (see judgment [64])]. The second was an article “How to beat Heart Disease” in the UK Mail on Sunday newspaper (Ref 2) and the third was Dr Malcolm Kendrick’s latest book “A Statin Nation” (Ref 3). Before I get on to Malcolm’s book, I have had the pleasure and privilege of spending many hours listening to Malcolm talking about heart disease. The logic with which he approaches the subject is second to none. I have come across no-one worldwide who has thought about this topic for as long and as openly as Malcolm has. He comes up with a hypothesis himself and then he tries to disprove it. If he can disprove it (and he usually can), he goes back to square one to consider a different hypothesis. The trouble with the cholesterol hypothesis, is that it can so easily be shown not to hold and yet those who believe in it won’t let it go. One of the most memorable things that Malcolm said about heart disease was this: We know that being male and getting older are risk factors for heart disease. But until we can explain why being male or why getting older increases the risk of heart disease, we don’t understand heart disease. It is not enough to say that older people are more at risk of heart disease – we need to explain why. The age paradox The Mail on Sunday (MoS) article thinks it knows why older people die of heart disease. I share this not because the media is an accredited source of medical information, but because millions more people will read a newspaper than an academic paper and it is important to be aware of beliefs – where they come from and how they get perpetuated. The MoS tells us: “As you get older… the effect of your diet and lifestyle accumulates over time leading to a build-up of cholesterol and plaque in the arteries. Four out of five people who die of heart disease are over 65.” But I had just been looking at the Appendix for last week’s Lancet paper and there was a very interesting table (Webtable 3). The full title for Webtable 3 was: “Mean plasma lipid concentrations at baseline and mean difference in plasma lipid concentrations at 1 year in participants in all studies, by category of age.” I captured only the left hand side of Webtable 3 I the image below, to show baseline cholesterol levels for the 186,854 people who were included in the Lancet statins study. The participants are grouped by age range. The top part of the table includes the 147,242 people in the statin vs. placebo trials. The bottom part of the table includes the 39,612 people in the lower vs. higher dose statin trials (those people were on some level of statin, hence the lower cholesterol levels overall). As you can see, the total cholesterol falls steadily from the youngest to the oldest age groups in both the top and bottom sections of the table. As you can see, the LCL-Cholesterol falls steadily from the youngest to the oldest age groups in both the top and bottom sections of the table. As you can see, HDL-cholesterol rises steadily from the youngest to the oldest age groups in both the top and bottom sections of the table [Webtable 3: Mean plasma lipid concentrations at baseline and mean difference in plasma] I used the main Lancet paper to extract the incidence of major vascular events (Figure 1) – given as a percentage per annum (pa). I then plotted the LDL-Cholesterol per age group against the incident rate per age group – whether the people were on statins (red line) or in the control group (green line), as shown in the diagram below. As the event rates ranged from 2.6% to 5%, this worked well using the same vertical axis – where LDL-Cholesterol ranged from 3.8 to 3.3 mmol/l. As you can see, and as you would expect, the cardiovascular incident rate goes up with age. As you can see, and the opposite of what the cholesterol hypothesis would tell us to expect, LDL-Cholesterol goes down with age and goes down as the incident rate goes up. So higher LDL-Cholesterol is not even associated with older age, or higher incidence of major vascular events, so how can LDL-Cholesterol cause heart disease? The Mail on Sunday further reported “It’s your ratio of LDL to HDL rather than overall cholesterol that matters”. Well, LDL-Cholesterol decreases with age and HDL-Cholesterol increases with age, so the over 75s have the absolute best cholesterol profile of all the age groups. Alas they have approximately double the incidence of major vascular events. As Malcolm would say “oops!” That’s a definite age ‘paradox’, which renders the cholesterol-heart hypothesis useless across men and women as an explanation of why older people get heart disease more than younger people. The gender paradox The gender paradox has long been known – women have higher average cholesterol levels and less heart disease than men. To provide a reference for this is surprisingly difficult, as data for average cholesterol levels are conspicuous in their absence. It has become common to report raised cholesterol levels, which are subjective judgments against a made-up cholesterol target, rather than actual average figures. The most recent European cardiovascular Disease (CVD) Statistics document (2017) provides information on cholesterol levels and disease by incidence by gender (Ref 4). P155 reported that “In Central and Eastern European and in Western Asian countries, raised blood cholesterol tended to be more common in females than in males.” To compare these higher cholesterol levels with heart disease: Table 1.5 (p.28-31) reported that 177 per 100,000 men died from heart disease vs. 87 per 100,000 women (Ref 5). That’s gender paradox. The many other paradoxes * The Japanese paradox Malcolm summarised numerous paradoxes in Chapter 13 of “A Statin Nation”. In this chapter he explored whether raised cholesterol (LDL) caused CVD. To illustrate the Japanese paradox, he reported that, over the past 50 years, the average cholesterol level has rising in Japan from 3.9 mmol/l to 5.2 mmol/l. Deaths from heart disease have fallen by 60% and rates of stroke have fallen seven-fold in parallel. A 25% rise in cholesterol levels has thus accompanied a six-fold drop in death from CVD (Ref 6) * Other paradoxes (from Malcolm’s chapter) The French paradox is well known – the French have the lowest cardiovascular disease (CVD) rate in Europe and higher than average cholesterol levels (and the highest saturated fat consumption in Europe, by the way). Russia has over 10 times the French death rate from heart disease, despite having substantially lower cholesterol levels than France. Switzerland has one of the lowest death rates from heart disease in Europe with one of the highest cholesterol levels. Malcolm reported the finding of an Austrian study: “In men, across the entire age range… and in women from the age of 50 onward only, low cholesterol was significantly associated with all-cause mortality” (Ref 7), i.e. people with low cholesterol were more likely to die from anything – not just heart disease. I was delighted to see that Malcolm included some of my work in his chapter. Back in 2010, I used the World Health Organisation data for all 192 where average (mean) cholesterol and death rates from CVD and all-causes were available. I showed that there was a relationship for men and women, with average cholesterol levels and CVD deaths and deaths from any cause – but that the relationship was inverse in every case (Ref 8). Lower cholesterol was associated with higher deaths and higher cholesterol was associated with lower deaths. This was for total cholesterol – LDL-Cholesterol data were not available, but LDL-Cholesterol is the major part of total cholesterol and thus it would be inconceivable that the associations were anything other than inverses for LDL-Cholesterol and deaths. The charts are as follows [set out]. The starting point to be able to claim that A causes B is for there to be a clear and consistent relationship between A and B. An inverse relationship exists between total cholesterol and LDL-Cholesterol and vascular incidents with age. An inverse relationship exists between total cholesterol and heart disease with gender. Inverse relationships exist between cholesterol and deaths from heart disease and deaths from any cause for males and females for all 192 countries in the world. Unsurprisingly numerous country paradoxes can be found among global country data. The ‘cholesterol causes heart disease’ hypothesis falls at the most basic level. If there is a clear and consistent relationship, it’s the opposite of what is claimed. Summary - The cholesterol-heart hypothesis has mutated many times over the years, but a central theme – that cholesterol causes heart disease – has prevailed. It used to be claimed that total cholesterol cause heart disease. More typically, we are now told that LDL-Cholesterol causes heart disease (that’s the cholesterol in a low density lipoprotein – one of the taxis in the blood stream). Sometimes the hypothesis is strained even further and we are told that the ratio of LDL-Cholesterol (that’s the ratio of cholesterol in one lipoprotein/’taxi’ to the cholesterol in another) causes heart disease. - Before it can be claimed that cholesterol causes heart disease, cholesterol and heart disease must have a clear and consistent relationship. - There is much evidence to show that, if there is such a relationship, it’s inverse, i.e. high cholesterol is associated with lower heart disease and vice versa. - An interesting table was found in the Appendix to the Lancet Statins for the over 75s paper. This showed that – before any intervention took place – total cholesterol and LDL-Cholesterol were lower, the higher the age group. However, vascular events were higher, the higher the age group. That confirms the inverse relationship. - The gender paradox has undermined the cholesterol-heart hypothesis for 50% of the population from the outset, as women have higher cholesterol levels and lower heart disease on average. That confirms the inverse relationship. - Other ‘paradoxes’ have been documented for specific countries. An examination of 192 countries, which I did in 2010, showed that the higher the total cholesterol, the lower the deaths from heart disease and the lower the deaths from any cause. This held for males and females. That confirms the inverse relationship. - To continue to believe that cholesterol causes heart disease is to disregard evidence to the contrary. References Ref 1: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)31942-1/fulltext Ref 2: https//www.dailymail.co.uk/health/article-6661327/How-BEAT-heart-disease-definitive-guide-worlds-experts.html Ref 3: https//www.amazon.co.uk/Statin-Nation-Damaging-Post-health/dp/1786068257 Ref 4: http://www.ehnheart.org/images/CVD-statistics-report-August-2017.pdf Ref 5: Heart disease was taken as IHD – Ischemic Heart Disease, the most recent data were from 2014 and the deaths were age standardised Ref 6: https://www.ncbi.nlm.nih.gov/pubmed/18174657 Ref 7: http://health-heart.org/eve-not-adam.pdf Ref 8: http://www.zoeharcombe.com/2010/11/cholesterol-heart-disease-there-is-a-relationship-but-its-not-what-you-think/ Annex 4: Public claims made by the Claimants relied upon by Mr Calman (see judgment [108]) (A). Claims (i) that LDL-C (or bad cholesterol) does not play a role in the causation of cardiovascular disease (and that low LDL-C) may be inversely associated with mortality and (ii) that statins ‘don’t work’ and offer no or negligible benefits even to patients at high risk (e.g. those who already survived a heart attack) as preventing cardiovascular disease has nothing to do with lowering LDL-C (1) First Claimant (i) “Replacing, not lowering, cholesterol would be more accurate”: blog,26 May 2014 , which Mr Calman summarised: “Dr Harcombe claimed that: ‘… pure (not-played-with) data from the World Health Organisation for 192 countries’ shows that the ‘true relationship between cholesterol and deaths’ is that ‘the higher the cholesterol, the lower the deaths from CVD’ or from any cause for men and women. This was under a section headed ‘Lowering cholesterol – General consensus vs. evidence’
‘In my view, the cholesterol test is worse than useless’; that statins ‘kill you one cell at a time’ and that ‘even if your friend has already had a heart attack, he has a 98.2/100 chance of statins doing nothing for him anyway (http://drmalcomkendrick.org/2014/12/01/what-is-t/)“. (ii) “Worried about cholesterol and/or statins”: blog,24 March 2015 , which Mr Calman summarised: “Dr Harcombe claimed that: The cholesterol test is a ‘scam’ and that her ‘top tip is: don’t have a cholesterol test and then you’ll have one fewer thing to worry about’. ‘HIGH cholesterol is associated with LOW deaths and LOW cholesterol is associated with HIGH deaths for men and women, CVD deaths and all-cause mortality.’ ‘If you are in the highest risk group possible (men of a certain age who have already had a heart attack), for every 100 of these men given statins for five years, 1.8 men will live, on average, an extra 6 months and 98.2 will gain no benefit’. ‘The intelligent thinking in the world of cholesterol is that any “benefit” of statins for this small, very high risk group, results from anti-inflammatory properties of statins; the cholesterol lowering being a serious price to pay’
‘I can’t advise anyone about what to do. I can only say what I would do. 1) I would not have a cholesterol test but you’ve already done that 2) if prescribed statins I wouldn’t take them. I’ve heard or other people use a term called ‘devious compliance’ when under pressure from the medical profession (which should be a crime in itself). They cash the prescription, but don’t take them’”. (iii) “The Lancet Statin Study”: blog,12 September 2016 [following The Lancet Review (see [62] in the judgment)], which Mr Calman summarised: “Dr Harcombe claimed that: ‘The first thing you need to know about the CTSU is that the spat that the CTSU leader, Rory Collins, kicked off with the BMJ in 2014 led to him having to declare the previously well-hidden pharmaceutical funding enjoyed by the CTSU. This added up to£268m ’. ‘I accept the second part (statins lower cholesterol); I do not accept that lowering cholesterol lowers heart disease. Statins may lower heart disease (by a tiny amount, which is outweighed by the harm they cause), but the non-industry-funded research that I have done shows that lowering cholesterol has no impact on heart disease and that some methods of lowering cholesterol increase heart disease. The intelligent view is that – any tiny benefit that statins may confer is due to their anti-inflammatory properties – the cholesterol lowering properties of statins are serious side effects’. ‘If the data (on benefits or side effects) were robust, there would be no concern about sharing them. Given that the data has been deliberately withheld since the CTT group was set up in 1994, we must assume that it would not withstand scrutiny’. ‘The claimed benefits for statins should be ignored because what really matters is not the number of events/deaths, but for what period of time statins may delay an event/death. The most recent and independent review, prior to this CTT pharmaceutical funded review, concluded that for a follow-up period of 2-6.1 years, the average postponement of death for primary (no previous cardiovascular event) and secondary (already had an event) prevention trials were 3.2 and 4.1 days i.e. take statins for 2-6.1 years and maybe buy yourself a couple of days – meanwhile, risk suffering from side effects for the entire time’. ‘Sadly, drug funded CTSU drug-promoters can claim whatever they like in a medical journal, with the breathtaking arrogance of those who literally cannot be challenged because they decide they won’t share anything that could be challenged, and they have no risk of repercussions, let alone jail. What is more, the editor of that journal supports this outrage unequivocally and has the audacity to assert that further debate on statins should not be allowed to continue. This is precisely why the debate must and will continue – whether the drug pushers and drug hiders and their conspirators like it or not’. (iv) “Statins in the over 75s”: blog,4 February 2019 [set out in full in Appendix 3(A)], which Mr Calman summarised: “I knew to doubt this claim as soon as I saw it because I worked on a paper published in 2016 with Dr Uffe Ravnskov as the lead author (Ref 10). The paper was called “Lack of an association or an inverse association between low-density-lipoprotein cholesterol and mortality in the elderly: a systematic review”. I spent several weeks doing the data extraction with Uffe and cross checking each other’s tables. I withdrew my name from the paper before publication because the correct (PRISMA) systematic review/meta-analysis methodology was not followed. This did not impact the results and, having seen the data first hand, the conclusion is robust. The conclusion was: “High LDL-C is inversely associated with mortality in most people over 60 years”. i.e. high LDL- cholesterol is associated with lower deaths in most people over 60”. (v) “Why cholesterol can’t cause heart disease”: blog,11 February 2019 , which Mr Calman summarised: “Dr Harcombe claimed that: ‘There is much evidence to show that, if there is such a relationship [between cholesterol and CVD], it’s inverse. i.e. high cholesterol is associated with lower heart disease and vice versa’. ‘An examination of 192 countries, which I did in 2010, showed that the higher the total cholesterol, the lower the deaths from heart disease and the lower the deaths from any cause.’ (2) Second Claimant (i) “Is cholesterol a cause of heart disease”: Interview with Dr Kendrick on BBC Radio 4’s Today programme on13 June 2016 (see [211] above), which Mr Calman summarised: “This interview was to publicise a review co-authored by Dr Kendrick entitled ‘Lack of an association or an inverse relationship between low-density-lipoprotein cholesterol and mortality in the elderly: a systematic review’ by Ravnskov et al on12 June 2016 on BMJ Open [see [210] above]. The study claimed to provide the ‘basis… for a re-evaluation of the guidelines for cardiovascular prevention, in particular because the benefits from statin treatment have been exaggerated’.) Dr Kendrick claimed that: The authors of the study ‘decided to try and find all the work that had been done looking at levels of LDL’ in the elderly ‘because this hadn’t been done before’ and ‘looking at over 68,000 people we found that essentially after the age of 60… if you have a higher LDL bad cholesterol level, you will actually live longer and there is no increased risk of CVD’
“Dr Kendrick made claims to like effect to BBC interviews, and claimed that: ‘The diet/heart cholesterol hypothesis [has been called] the greatest scam in the history of medicine. It seems that is right”.’ (iii) “High cholesterol ‘does not cause heart disease’ new research finds, so treating with statins ‘a waste of time’”: Article in The Daily Telegraph,13 June 2016 , which Mr Calman summarised: “Dr Kendrick made claims to like effect to BBC interviews, and claimed that: ‘cholesterol does not cause heart disease in the elderly and trying to reduce it with drugs like statins is a waste of time… The guidelines for the prevention of CVD and atherosclerosis should be re-evaluated because the benefits of statin treatment have been exaggerated… The findings would cause controversy but were robust and thoroughly reviewed”.’ (iv) “A Statin Nation”: published on27 December 2018 , from which Mr Calman identified: “Back cover: ‘people are being conned. It is clear that statins are not all that is claimed for them… Commonly-viewed as a wonder-drug, in reality, as the book shows, they increase life expectancy by a negligible amount, while adverse effects are all too often concealed. The way to avoid heart disease, and strokes, is simple – but it has nothing to do with lowering cholesterol levels.’” (B). Claims that the incidence of adverse effects caused by statins was being hushed up and the true rate was about 20 per cent (1) First Claimant (i) Mr Calman has identified several Tweets of the First Claimant posted on 12-13 February 2014 , following an interview with Dr Malhotra that was broadcast on BBC Radio 4’s Today programme on12 February 2014 . In square brackets I have noted the number of ‘likes’ and/or Retweets and or replies the relevant Tweet received (as recorded in the evidence): “Scandalous reporting of side effects Go @DrAseemMalhotra On Radio 4 now” [1 like] “@DrAseemMalhotra’s opponent on @BBCRadio4today was Mark Baker. Past links = Roche and Pfizer. NICE supposed to be independent” [4 Retweets, 2 replies] “This was yesterday’s news [link to article in Independent] Today’s news is give everyone statins. Spot the connection!” [12 Retweets, 1 like] “Thank goodness at least one sane and non-conflicted person was quoted @DrAseemMalhotra. Good Jon Abramson quote too [link to Guardian article] [2 Retweets, 1 like] “NICE & anyone half persuaded to listen to the outrageous headlines today should read this [link to the First Claimant’s Blog article “How statin drugs really lower cholesterol and kill you one cell at a time” [10 Retweets, 2 likes] “An even better @drbiffa post on Mr BHF [link which Mr Calman says states that “chances of significant side effects including diabetes, muscle pain, fatigue, liver damage or kidney damage are about 20 per cent” [no likes, Retweets or replies] “How great to see this counter to yesterday’s profit-motivated scare-tactics [link to Daily Mail article, written by Dr Malhotra, under the headline: ‘As go-ahead’s given for one in four adults to be offered heart drug, one doctor says this mass pill-popping is folly’ in which he stated: ‘reliable data from the real world, published recently in the British Medical Journal and backed up by anecdotal evidence from my experience as a cardiac physician, suggests that the real figure for serious side-effects associated with statin use is closer to one in five] Well done @draseemmalhotra” [6 Retweets, 1 like, 1 reply] “[Link to same Daily Mail article] This needs conflicts declared. @DrAseemMalhotra none. Baigent = Astra Zeneca, Merck, GSK, & J&J (google him and Merck)” [no likes, Retweets or replies] “[Link to same Daily Mail article] Big Colin Baigent study funded by Merck [link to Lancet article in 2011]. No such funding for @DrAseemMalhotra” [no likes, Retweets or replies] (ii) Mr Calman also identified further Tweets of the First Claimant posted between 16-19 May 2014 . The context was that, on15 May 2014 , the BMJ (and authors of the relevant papers) withdrew the figures that suggested that 20% of patients prescribed statins suffered adverse side-effects and announced an inquiry by an independent panel: “This is so serious – barely days after Australian dissent was silenced, UK freedom/truth is under attack” [This was a reply Tweet, with 1 like] “This is so serious [link to article on BBC news website] The CTT won’t release Serious Adverse Effect data so how can we know [link to article on www.healthinsightuk.org ‘SOS sanity over statins CTT the house of statin secrets’]” [9 Retweets, 2 likes, 10 replies] “This is the official BMJ article [link given]. The BMJ was alerted by Rory Collins – the top dog who refuses to share the SAE info” [1 Retweet] “Will this panel have the power to force CTT to release the SAE data on statins that they refuse to disclose?” [3 Retweets, 1 like] “@DrAseemMalhotra standing up to pharma funded bullies [link to article in the Independent under the headline: ‘Statins row critics are biased says doctor who warned of drugs side-effects’] [16 Retweets, 9 likes and 2 replies] “Collins seems to have forgotten to have declared over£100 million in drug company money. He must be on statins! [link to Blog post ‘It’s not about statins, it’s about censorship’]” [19 Retweets, 7 likes, 3 replies] (iii) Mr Calman identified the First Claimant’s Blog post on,19 May 2014 , “It’s not about statins, it’s about censorship” in which he said that the First Claimant had claimed, in reference to the BMJ’s withdrawal of the figure of 18-20% of people taking statins experiencing side-effects: ‘In the UK, in the same week, same drug, we also experience censorship. You [Professor Collins] head the CTT. Why will the CTT not release Serious Adverse Effect data (and raw data generally) from clinical trials so that researchers, doctors and patients can fully understand the side effects of statins? How can you claim that statin side effects are negligible when you won’t share the data?’ (iv) Mr Calman also identified the First Claimant’s Blog post on,19 June 2014 , “Doctor’s tell NICE you’re not independent and you’re not evidence based”
‘Professor Collins has attacked the BMJ for publishing articles about statins which claim that they have significant side effects’ and that he and Professor Magdi Yacoub who is also ‘pressing the “you’re killing patients” button with great enthusiasm’ are engaging in ‘the tactics of the playground bully’ by ‘claiming that the alarm caused by [the BMJ’s articles] was probably killing more people than had been harmed as a result of the paper on the MMR vaccine by Andrew Wakefield’. (iii) Press release, dated10 June 2014 , “Leading Doctors Reject Statin Guidance from the National Institute for Health and Care Excellence” referencing a letter to NICE dated10 June 2014 , of which the Second Claimant was one of 9 signatories. The press release included: ‘[The signatories] call on the Cholesterol Treatment Trialists Collaboration who have commercial agreements with the pharmaceutical industry to release all data on statins which is currently being concealed for review by independent researchers to help explain major discrepancies in several industry sponsored studies of statin adverse events.’ (iv) Interview with the Second Claimant on BBC Breakfast on11 June 2014 in which he claimed: ‘… we’re putting another five or six million people on medication, which I believe causes quite a lot of side effects, for the rest of their lives’
‘… when you do clinical studies, you’re doing them in a very artificial population... Unfortunately, we’re told, well that’s anecdotal data,, and you know anecdotes don’t equal data, but the reality on the ground is that you do see an awful lot of people with significant side effects. And is it worth it? Because when we’re looking at a risk of 10%, the actual benefits, the benefit of say extending your life, is vanishingly small, if it exists at all… pain, difficulty getting up, memory loss, stomach pains, irritation, mood changes are quite common things. If you don’t ask for them patients won’t tell you these things but the reality is that they are common.’ (v) “A humiliating climb down – or a Machiavellian move?”: Second Claimant’s blog,16 February 2015 (in response to publication of the Report of the Independent Panel (see [206] judgment), from which Mr Calman noted that the Second Claimant had said that Sir Rory Collins had “ruthlessly attacked anyone who dares make any criticism of them… he tried to get the BMJ to retract two articles claiming that statins had side effects of around 18-20%. He stated that these articles were irresponsible, worse that both articles [published in the 2013 BMJ 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 worthy of instant retraction and apology… 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 the CTT may, or may not, hold”. (vi) In an article in The Scotsman,4 May 2017 , published following publication of a study in The Lancet, on2 May 2017 , “Adverse events associated with unblinded, but not with blinded, statin therapy in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid-Lowering Arm”, the Second Defendant stated: ‘… a “nocebo” effect? All in the mind? No, of course not… I have spoken to many other GPs who have reported seeing side-effects in many patients taking statins. I suppose if you are trying to push statins as hard as possible, and you built your academic reputation on running trials on statins, you will naturally want to push them as hard as possible… But this latest report pushes things to a completely ridiculous point… The reality is that, unless you have had a previous heart attack, statins have no effect on overall mortality. To put that another way: they don’t save lives. The don’t even prevent heart attacks or strokes in women with no previous history of heart disease… The statistic you really want to know about statins is the following. If you have had a heart attack, or stroke, and take a statin for five years, you will increase your life expectancy by 4.2 days. Balance that against a 20 per cent chance of having side-effects, some of which are very unpleasant and long-lasting, and you can see why I’m no fan of statins.’
‘Stripping aside all the horrible dead science speak, I shall translate: “You only think you are having an adverse effect of taking a statin, the reality is that you have been fooled into thinking this. You are not. So stop whinging, you pathetic worm. By the way anyone who criticises statins should probably be thrown in jail… I put it to you that writing off patient-reported symptoms of muscle pain and weakness as the nocebo effect is medicine at its very very worst. Paternalistic, dismissive, it flies in the face of the evidence…” (viii) “Response to the Lancet Paper”, responding to The Lancet 2019 Study (see [64] judgment): Second Claimant’s blog,3 February 2019 (see [73] judgment), the Second Defendant stated: ‘I can stop people dying from heart disease by pushing them off the edge of a cliff. They might not like the end result… Statins might alter what is written on your death certificate but they are extremely unlikely to change the date… 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 [heart attacks] 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…’ (C). Claims that the researchers who have conducted the biggest statin studies, in a conspiracy with the pharmaceutical companies, had allowed their judgment to be influenced by their financial interests and the evidence they produced, notably the evidence from the RCTs which was biased and untrustworthy (1) First Claimant (i) “Statins: just say no. Sensible reasons why they are stupid medicine”, an article published in Health Insight on17 February 2014 . Mr Calman cites this as instance where the First Claimant claimed that it was an “absolute disgrace” and “unforgiveable” that the NICE guidance development groups’ interests “are not declared in the report even though NICE claims to be a body producing evidence based guidance… created by independent and unbiased advisory committees”; that “the Chair… used to be a HEART UK trustee, a body which calls itself the cholesterol charity but it is actually the mouthpiece of the statin and polyunsaturated spread manufacturers. No doubt Mr HEART UK resigned as a trustee before heading up the group looking at statin guidelines in the UK, but his hand has been clearly declared, in addition to his previous leadership at HEART UK, declares interests in Amgen; Genzyme Corporation; Merck, Sharp & Dohme; Pfizer and Sanofi-Aventis; and the guideline development group were not “a truly independent and unbiased bunch”. (ii) “SOS: Sanity over Statins – Sssssh Side effects, pharma’s fingers and a cunning plan”, an article published in Health Insight on4 March 2014 . Mr Calman cites this as instance where the First Claimant stated, of the statement by the CTT that the agreement with the academic investigators of the trials that trial data will not be released to third parties “was necessary in order that analyses of the totality of the available trial data could be conducted by the CTT Collaboration”: ‘Pull the other one. Such an agreement is necessary to protect the interests of the companies who stand to lose billions if unfavourable data is released. That’s why observers are present. That’s why the drug company web runs through CTT, NICE and the bodies that are supposed to be acting in the public interest. And who is acting in the interests of doctors who do not wish to inflict harm? Or the patients who do not wish harm inflicted upon themselves?’ (iii) “NICE has ended any debate about its independence”: First Claimant’s blog,14 July 2014 : ‘The NICE approach to conflict is an utter disgrace and the Department of Health needs to intervene urgently to establish a medical advisory body that is genuinely independent and evidence-based. Not one that is staffing guideline development groups with conflicted majorities and then publishing the views of these drug/surgery representatives as policy for practitioners to be ordered to adhere to.’ (iv) “And underhand stunt revealed a pharma funded web”: First Claimant’s blog,6 October 2014 . Mr Calman identified and relied upon the following claims by the First Claimant: • The survey by the British Cardiovascular Society (“BCS”) in 2014 was ‘not an open and genuine survey – honestly interested in evidence based medicine [but] a loaded and leading survey… with a clear and underhand end in mind’. • ‘The Joint British Societies – when declarations are fully made – reads like a pretty comprehensive representation of the statin making pharmaceutical industry. Sure enough, this is the Joint British Societies view on lipid lowering therapy: “Intensive statin therapy is recommended…”‘. • Representatives from the Joint British Societies (“JBS”), and various named academics and doctors claimed no declaration of interest, and yet their research showed that they had received money from pharmaceutical companies. • The First Claimant had ‘discover[ed] a web of organisations, charities and affiliates with pharmaceutical funding, shared addresses and what seems to be an extensive network of statin pushers. Why? 1) It gives the appearance of a number of “respectable’ organisations/charities all believing in the same thing. In this case that “intensive statin therapy” should be enforced with a ‘lower is better” approach and 2) it creates a “once removed” structure, so that the pretty much universally conflicted members of the Joint British Societies group seem to think that it’s OK that they put their names to a “lower is better” policy as members of the JBS and then “forget” that they are funded by companies who will benefit from this exact policy’. • The First Claimant ‘given [her] abhorrence towards conflicts of interest [the reader] won’t be surprised to know that [she] has received no such payments from any organisation and never will [she] sell [her] soul in this way. It’s just disgraceful that this position is not shared by people in positions of power and influence.’ (v) Mr Calman has identified several Tweets of the First Claimant posted on11 September 2016 , following publication of The Lancet Review (see [62] in the judgment). In square brackets I have noted the number of ‘likes’ and/or Retweets and or replies the relevant Tweet received (as recorded in the evidence): “Just looking at the mother of all statin propaganda [link to The Lancet Review] NB CTSU never share data (ensures truth can’t be uncovered)” [9 Retweets, 3 replies, 8 likes] “Drug funded team claim statin side effects 0.5-1% [Link to The Lancet Review]. How come the [patient information leaflet] has effects for 1 in 10? [link to example of patient information leaflet]” [3 Retweets, 7 likes] “Remember the recent conclusions of non drug funded study [Link to a study published in The BMJ on24 September 2015 , “The effect of statins on average survival in randomised trials, an analysis of end point postponement” (see [209] in judgment)] Take statins for 2-6 years & maybe gain 3-4 days (+ SAEs)” [19 Retweets, 2 Quote Tweets, 21 likes, 2 replies] (2) Second Claimant (i) “Statin fan funded by drug firm”; Article in the Scottish Express on30 March 2014 . Mr Calman identified the following quote attributed to the Second Claimant: ‘Professor Collins may claim to receive no funding directly from industry. However, his personal and professional standing is underpinned by his research unit which relies on industry funding.’ (ii) “You are killing patients”: Second Claimant’s blog,4 June 2014 , from which Mr Calman identified claims by the Second Claimant: • Anyone who dares to criticise statins “is subjected to vitriolic attacks and a demand for silence” by Professor Collins. • The survey by the British Cardiovascular Society (“BCS”) “is a very unsubtle variation of the ‘You’re killing my patients’ tactic which is regularly used to silence any who dares criticise current medical opinion”. • “The BCS are funded and supported by the pharmaceutical industry. Any industry that is not, currently, that bothered about statins – as the patents have run out. But it is an industry that remains extremely interested in the whole idea of lowering cholesterol. Which remains THE multi-multi-billion dollar market. Any attack on statins threatens the foundations of this market, one that has been painstakingly constructed over the last thirty years”. • “The following attack by the BCS can be considered, to all intents and purposes, an attack by the pharmaceutical industry on anyone who dares to suggest that drugs lowering cholesterol may not be such a brilliant idea. So when you see the headlines in the newspapers damning and rubbishing Aseem Malhotra, John Abramson, and me (and a few others), you know exactly where this attack originated and why”. (iii) “Medical censorship in the twenty first century”: Second Claimant’s blog,11 September 2016 , posted following publication of The Lancet Review (see [62] in the judgment), from which Mr Calman identified claims by the Second Claimant: • The editorial in The Lancet was “the most frightening thing you will read this year, possibly this decade and maybe the entire century as it is a direct attack on human freedoms’ and that ‘what [the editor] is saying is that any who questions current accepted medical dogma should be very tightly controlled, and probable 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…” • The editorial’s conclusion that ‘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’, “is basically censorship”. (iv) “It’s official statins do not have any side effects”: Second Claimant’s blog,8 May 2017 , posted following publication of a study in The Lancet, on2 May 2017 , “Adverse events associated with unblinded, but not with blinded, statin therapy in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid-Lowering Arm”, from which Mr Calman identified claims by the Second Claimant: • “… you could argue that the nocebo effect can only account for 0.26% of adverse effects. Therefore, the other 29.74% (30% in the Statin USAGE study – 0.26% nocebo effects) represents the true rate of adverse effects. You could argue that randomised controlled clinical trials do not reflect the experience of taking medication in the real-world environment. You could say that you believe one of these studies, but not both…” • “… on the other hand you could move sideways a bit, and wonder why researchers suddenly decided to ‘data dredge’ a twenty-year old study – not set up to look at adverse effects as a primary end-point – to prove that statins do not have any adverse effects. You could then look at who funded that research and you could ask yourself why would a company currently being sued in the US for not highlighting the adverse effects of statins, decided to use a study to prove that statins do not have adverse effects”. • “Alternatively, you could ask people who have taken statins, whether they suffered adverse effects, and try to match the number who claim that they do, with the one in ten thousand figure of Professor Peter Sever. And good luck with that. It is hard, I find, not to think that ‘he who pays the piper calls the tune’”. (v) “Cholesterol lowering the end of the beginning”: Second Claimant’s blog,22 May 2017 , posted following publication of the same study in The Lancet, on2 May 2017 , from which Mr Calman identified claims by the Second Claimant: • “… it turns out that the lead author… was provided with financial support for the ‘Foundation of Circulatory Health’