Zoë Harcombe PhD & Anor v Associated Newspapers Limited & Anor

a news article, which was published in the print edition of The Mail on Sunday on page 2 of the newspaper, under the headline: “Statin deniers are putting patients at risk, says Minister” (“the News Article”);

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” (p.47), “‘It’s worse than the MMR scare’ (pp.48-49) “‘Side effects are down to worry, not statins’” (p.50) (“the Main Article”); and “REVEALED: TRUTH ABOUT THE THREE ‘EXPERTS’ WHO SAY DON’T TAKE STATINS” (p.48) (“the Text Box”); and

an editorial, by Mr Calman which was published on page 50 of the newspaper, under the headline: “There is a special place in hell for the doctors who claim statins don’t work” (“the Editorial”).

in respect of each Claimant:

and, additionally, in respect of the Second Claimant:

in respect of each Claimant:

and, additionally, in respect of the Second Claimant:

in the print edition of the newspaper, (a) the News Article, and (b) the Main Article and the Editorial (defined as “the Health Section”) would be read separately: “the two parts were not sufficiently closely connected as to be regarded as a single publication. A reader who read only the self-contained News Article and not the Health Section (or vice versa) would not be an unreasonable reader”;

in consequence, the News Article, read alone as a distinct publication, did not refer to the Claimants as they were not identified in it; alternatively,

if the three print Articles are sufficiently connected to be regarded as a single publication, then it is admitted that they referred to the Claimants;

Online Publication 1 was a “single continuous online article”, but the online publication was in a different form from the print publication in that “the articles appear in a different order with different headlines, photographs and captions, and the [Text Box] did not appear as part of the online publication”; and

Mr Calman denies that he was the author of the News Article, but admits that he caused the News Article to be published.

honest opinion, pursuant to s.3 Defamation Act 2013;

truth, pursuant to s.2 Defamation Act 2013;

statutory qualified privilege, pursuant to s.15 Defamation Act 1996 (“s.15 reporting privilege”);

statutory qualified privilege, pursuant to s.6(5) Defamation Act 2013 (“privileged report of peer-reviewed scientific or academic journal”); and

publication on a matter of public interest, pursuant to s.4 Defamation Act 2013 (“public interest”).

“The Defendants admit that the First Defendant published, and the Second Defendant caused to be published, the articles complained of by the Claimants in The Mail on Sunday on 3 March 2019 and online on Mail Online and on a continuing basis… The Defendants deny that the articles bear the defamatory natural and ordinary meanings, or in the case of the [online publication of the News Article], the innuendo meaning, ascribed to them by the Claimants… The Defendants admit that the articles are defamatory at common law, save in respect of [the print and online versions of] the News Article… when read alone. No admissions are made as to whether the articles have caused or are likely to cause serious harm to the Claimants’ reputations”.

The Claimants are (each) among those who have published claims denying the health benefits of statins; specifically they have claimed that (a) cholesterol is not a cause of heart disease, (b) lowering cholesterol with statins produces a negligible benefit for patients prescribed statins, (c) the medical establishment (including pharmaceutical companies, charities, doctors, researchers and universities) is covering up the true extent of the side effects of statins, and (d) the medical establishment has conspired to silence the Claimants and other ‘statin deniers’, to cover up the truth (as presented by the Claimants and others), and to ensure as many people as possible take statins, in order to boost profits for the statin industry.

The Claimants’ (respective) behaviour in making such claims is irresponsible, reckless and deserves to be condemned, in light of:

The Claimants’ (respective) behaviour in (1) above is an example of medical misinformation or ‘fake health news’, the potential harmful consequences for public health of which far outweigh that of the infamous MMR vaccine scandal.

(In relation to the Health Section in the print publication only) The Claimants’ resolute persistence in making these claims, in the face of the strength of the expert evidence in support of statins, begs the question why they are doing it, whether they have too much to lose commercially or in terms of their high public profile to stop making their claims, and/or do profit and/or stand to profit by their stance”.

The Claimants were each reckless, irresponsible and condemnable in repeatedly making the following public claims, that (a) cholesterol is not a cause of heart disease, (b) lowering cholesterol with statins produces only a negligible benefit for patients prescribed statins, (c) the medical establishment (including pharmaceutical companies, charities, doctors, researchers and universities) is covering up the true extent of the side effects of statins, and (d) the medical establishment has conspired to silence the Claimants and other ‘statin deniers’, to cover up the truth (as presented by the Claimants and others), and to ensure as many people as possible take statins, in order to boost profits for the statin industry.

The Claimants were each reckless, irresponsible and condemnable in this regard because (as they were or must have been aware);

(In relation to the Health Section [i.e. the Main Article and the Editorial] only) The Claimants’ resolute persistence in making these claims, in the face of the strength of the expert evidence in support of statins, creates a reasonable suspicion that they have too much to lose commercially or in terms of their high public profile to stop making their claims, and/or do profit and/or stand to profit by their stance”.

the parts highlighted in red in Annex 1 (and shown underlined in Annex 2) (Footnote: ¹), are protected by qualified privilege as an extract and/or summary of a statement by the Secretary of State for Health and Social Care (“the Hancock Statement”) pursuant to s.15 Defamation Act 1996, paragraph 7 and/or paragraph 9(1)(a) and/or (b) of Part II of Schedule 1; and

the parts highlighted in blue in Annex 1 (and shown with double underlining in Annex 2) (Footnote: ²), are protected by qualified privilege as an extract and/or summary of a statement by Dr Matt Kearney (“the Kearney Statement”) pursuant to s.15 Defamation Act 1996, paragraph 9(1)(b) of Part II of Schedule 1.

(The relevant parts of the Defamation Act 1996 are set out in [292]-[293] below).

In June 2016 an interrupted time series analysis by Professors Anthony Matthews, Ben Goldacre and Liam Smeeth from the London School of Hygiene and Tropical Medicine (“LSHTM”) and others entitled ‘Impact of statin related media coverage on use of statins: interrupted time series analysis with UK primary care data’ (“the LSHTM paper”), published in the [British Medical Journal (“BMJ”), 28 June 2016], evaluated the effects of the media debate about statins in the UK in 2014 (in which claims published in the BMJ that 20% of patients taking statins suffered adverse effects, and which were subsequently withdrawn as being incorrect, prominently featured) on prescribing for both the primary and secondary prevention of cardiovascular disease and the consequences for public health. Analyses of the Clinical Practice Research Datalink in 2014-15 indicated that:

The LSHTM paper was a statement that related to a scientific or academic matter, namely an interrupted time series analysis of how a period of intense media coverage of controversy over the risk:benefit balance of statins had affected their use using prescribing data from UK primary care records.

Before the LSHTM paper was published in the BMJ an independent review of the statement’s scientific and/or academic merit was carried out by (i) Dr Wim Weber, the European research editor of the BMJ, and/or the member or members of the BMJ’s manuscript committee responsible for the decision to publish the LSHTM paper, and (ii) external peer reviewers, each of whom had scientific and/or academic expertise in the matter concerned for the purposes of section 6(3)(b). Insofar as is necessary, the Defendants will contend that each member of the BMJ’s manuscript committee also had scientific and/or academic expertise in the matter concerned for the purposes of section 6(3)(b). Further, Dr Weber and/or each member of the manuscript committee responsible for the decision to publish the LSHTM paper was or were the editor or editors for the purposes of section 6(3)(a) (as construed with section 6(8))

In the premises, the words [highlighted in green in Annex and shown dotted-underlined in Annex 2] were (i) a fair and accurate extract or summary of a peer-reviewed statement which related to a scientific and/or academic matter and were published in a scientific and/or academic journal within the meaning of sections 6(2) and 6(3) of the 2013 Act, and (ii) were published on an occasion of qualified privilege pursuant to section 6(5) of the 2013 Act”.

“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 of s.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.

The Claimants deny that any of the publications complained of is honest opinion under s.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.

The Claimants deny that any of the publications complained of is substantially true under s.2 of the Defamation Act 2013...

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 …

The Claimants deny that statutory reporting qualified privilege under s.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…

The Claimants deny that peer-reviewed scientific statement privilege under s.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...

The Claimants deny that the publications complained of (or any of them) is a publication on a matter of public interest under s.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…”

in respect of the extracts from the Hancock Statement, that:

in respect of the extracts from the LSHTM Paper, that:

Particulars of both pleas of malice were given in the Reply.

the Defendants, through Mr Calman, had misused the reporting privilege relied upon to obtain a private advantage in terms of bolstering the credibility of the allegations made in the Articles, and this was the dominant purpose for publishing the privileged statement; and/or

the relevant report was published recklessly not caring whether the report given was true or false.

[4] Early in the proceedings, the parties tried to find a way of advancing the case in stages, as is now common in defamation claims. Obvious candidates for early resolution in most claims are the issues of meaning and whether the publication complained of was or contained an allegation of fact or expression of opinion. Resolution of these issues in most defamation claims, even prior to service of a Defence, can offer substantial benefits in terms of case management, see Bokova -v- Associated Newspapers Ltd [2019] QB 861 [10] and Morgan -v- Associated Newspapers Ltd [2018] EWHC 1850 [10]. 

[5] In this case, there were difficulties in resolving these issues arising from the Defendants’ reliance upon qualified privilege (on several bases) to protect publication of certain paragraphs of the articles. The articles contain a statement by the Secretary of State for Health as well as reference to some scientific studies. The Defendants rely upon defences of qualified under s.15 and Schedule 1 Part 2, para.9(1)(b) Defamation Act 1996 and s.6 Defamation Act 2013. 

[6] The complicating factor is the Court of Appeal’s decision in Curistan -v- Times Newspapers Ltd [2009] QB 231. That decision, which predated the Defamation Act 2013, is authority for the position that the court must resolve the extent to which the publication complained of is protected by privilege before the court can determine meaning. In other words, when performing the test of deciding what is the meaning, the natural ordinary meaning of an article, the court must first remove from its consideration such parts of that article as the court finds is protected by qualified privilege. 

[7] There has been some criticism of that decision. The authors of Gatley suggest, at para.30.8:

[8] One of the consequences of the Curistan principle in relation to this claim is that it stands as a fairly significant impediment to the court determining the natural and ordinary meaning of the article. To do so, the court would have to resolve the question of qualified privilege. The determination of whether the pleas of qualified privilege protect parts of the publications complained of, in turn, would require the court to determine also the plea of malice that the Claimants have advanced. There are other implications of Curistan which have emerged only since the Defamation Act 2013. As the objective meaning of a publication is likely to be an integral part of the assessment of serious harm under s.1 Defamation Act 2013, that means that any dispute as to serious harm to reputation could also only be carried out after the issues regarding qualified privilege have been resolved.

[9] There is no doubt that the impediment that Curistan represents has significant implications for this case and its case management. The court now has the benefit of full statements of case filed by the parties. It is no exaggeration to say that the parameters of this litigation are very substantial. Indeed, this is the most significant piece of defamation litigation that I have seen in a very long time.

With the benefit of reflection, on what was an ex tempore judgment, I think the final sentence of [6] misstates the decision. The effect of the Court of Appeal decision is that any privileged words can and should be considered as “context” when determining the meaning of the non-privileged parts (see [399] below). Nevertheless, the point remains: the Court cannot finally determine the natural and ordinary meaning of an article that includes parts in respect of which there is an unresolved privilege claim. I will return to consider the Curistan decision in more detail later in the judgment (see [388]-[400] below).

The following issues will be tried separately from, and in advance of, any other issues in the proceedings (at a trial referred to below as Trial 1):

The issues of honest opinion (save as identified in paragraphs 1.11 and 1.12 above), truth, serious harm and (if applicable) remedies are stayed until the conclusion of Trial 1 when they will be reviewed”.

The Court is not adjudicating upon the merits of the debate about statins. In other words, in this judgment, the Court is not going to determine who is “right” in the statin debate. Properly reflecting the parameters of the Court’s task in this trial, I have not heard any expert evidence about statins. Such evidence would have been essential if the Court were being required to adjudicate on who was “right” in the statin debate. Although I shall have to consider a significant number of scientific studies into statins in the course of this judgment, this is because it is the existence of these studies (and what they said) that is relevant to the determination of the public interest defence (and one of the privilege defences). In this judgment, the Court is not going to resolve any apparent conflict between scientific studies as to the benefits (or risks) of statins. That is outside the scope of the issues to be decided in this litigation at this stage.

In consequence, the Court is not deciding any issues as to whether the published studies or claims of the Claimants (or any of the other experts whose work is considered in the course of this judgment) were accurate or inaccurate; reliable or unreliable; honest or dishonest. That issue is also outside the scope of this judgment, and I simply have not had the evidence presented to me that would enable me fairly to adjudicate upon those issues. The Claimants have not given evidence, and nor have the various experts that were assisting Mr Calman with the Articles (because none of them has any relevant evidence to give on the issues that the Court must decide).

In resolving the public interest defence, and reflecting the principles of law that are set out in Section G(1) below, the key issue that the Court is resolving is whether the Defendants (and for these purposes, that is Mr Calman) reasonably believed that it was in the public interest to publish the Articles. To resolve that issue, the Court must assess the journalism that led to publication of the Articles; what inquiries were made, what did Mr Calman know, what information did he receive, what opportunity did he give to the Claimants to comment and respond to allegations to be made against them and how ultimately did he present all of this material in his Articles?

Mr Calman;

John Wellington, Managing Editor of The Mail on Sunday until his retirement in October 2020 (“Mr Wellington”);

Edward Verity, now Editor of The Daily Mail but, at the time of publication of the Articles, Editor of The Mail on Sunday (“Mr Verity”); and

Stephen Adams, Medical Editor of The Mail on Sunday (“Mr Adams”).

“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…”

“I am not a single issue journalist: every week we write about a huge range of topics. Therefore, whilst I am broadly aware of lots of pockets of information – in this case her general view on statins – it is usually only once an article is underway that I will devote the time to look into people or topics in detail and start amassing information on them in order to work out what the article is going to say precisely. That is what I then started doing in preparation for this article”.

“He thinks the mainstream advice around cholesterol is a conspiracy or ‘con’ as he says to trick people into taking statins. He may have even come up with the term ‘statination’ which you hear bandied about and which I understand to mean a mission by drugs companies and some in the medical establishment to get everyone on statins”.

“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”.

It is perhaps a small detail, but Mr Calman did not realise that the Second Claimant was a practising GP until very shortly before publication of the Articles following receipt of the Second Claimant’s right-to-reply response (see final bullet point in the email sent to the Second Claimant by Mr Calman on 28 February 2019, [190] below).

“… [these] articles both cited an observational study to claim that 20% of patients on statins experience ‘unacceptable’ side-effects based on a misinterpretation of observational data (aside from being inaccurate, this figure was a far higher proportion than the large-scale randomised controlled trials had showed). After that there was a huge amount of public interest in and publicity about the risks and benefits of statins, which flared when the National Institute for Health and Care Excellence (“NICE”) published new draft guidance on the use of statins in February 2014, which proposed lowering the threshold for offering statin treatment (from a 20% risk of developing cardiovascular disease over 10 years to a 10% risk over 10 years… This guidance was adopted later in the year. When the figures from the [2013 BMJ Articles] were repeated in the context of public discussion of NICE’s draft guidance, this prompted widespread questioning of the risk-benefit of statins. The BMJ article and study were corrected by the BMJ and the authors over six months later in May 2014. This fallout from the two [2013 BMJ Articles] was widely reported and the subject of research, most significantly the [LSHTM Paper] on 28 June 2016”.

“… [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.”

That was consistent with Mr Calman’s own evidence about the Campaign. “… [The] campaign was called ‘Fight Fake Health News’; it’s quite clear what the agenda is there…”.

“This Review is intended to help clinicians, patients, and the public make informed decisions about statin therapy for the prevention of heart attacks and strokes. It explains how the evidence that is available from randomised controlled trials yields reliable information about both the efficacy and safety of statin therapy. In addition, it discusses how claims that statins commonly cause adverse effects reflect a failure to recognise the limitations of other sources of evidence about the effects of treatment. Large-scale evidence from randomised trials shows that statin therapy reduces the risk of major vascular events (i.e., coronary deaths or myocardial infarctions, strokes, and coronary revascularisation procedures) by about one-quarter for each mmol/L reduction in LDL cholesterol during each year (after the first) that it continues to be taken. The absolute benefits of statin therapy depend on an individual’s absolute risk of occlusive vascular events and the absolute reduction in LDL cholesterol that is achieved. For example, lowering LDL cholesterol by 2 mmol/L (77 mg/dL) with an effective low-cost statin regimen (e.g., atorvastatin 40 mg daily, costing about £2 per month) for 5 years in 10,000 patients would typically prevent major vascular events from occurring in about 1,000 patients (i.e., 10% absolute benefit) with pre-existing occlusive vascular disease (secondary prevention) and in 500 patients (i.e., 5% absolute benefit) who are at increased risk but have not yet had a vascular event (primary prevention). Statin therapy has been shown to reduce vascular disease risk during each year it continues to be taken, so larger absolute benefits would accrue with more prolonged therapy, and these benefits persist long term. The only serious adverse events that have been shown to be caused by long-term statin therapy—i.e., adverse effects of the statin—are myopathy (defined as muscle pain or weakness combined with large increases in blood concentrations of creatine kinase), new-onset diabetes mellitus, and, probably, haemorrhagic stroke. Typically, treatment of 10,000 patients for 5 years with an effective regimen (e.g., atorvastatin 40 mg daily) would cause about 5 cases of myopathy (one of which might progress, if the statin therapy is not stopped, to the more severe condition of rhabdomyolysis), 50–100 new cases of diabetes, and 5-10 haemorrhagic strokes. However, any adverse impact of these side-effects on major vascular events has already been taken into account in the estimates of the absolute benefits. Statin therapy may cause symptomatic adverse events (e.g., muscle pain or weakness) in up to about 50–100 patients (i.e., 0·5–1·0% absolute harm) per 10,000 treated for 5 years. However, placebo-controlled randomised trials have shown definitively that almost all of the symptomatic adverse events that are attributed to statin therapy in routine practice are not actually caused by it (i.e., they represent misattribution). The large-scale evidence available from randomised trials also indicates that it is unlikely that large absolute excesses in other serious adverse events still await discovery. Consequently, any further findings that emerge about the effects of statin therapy would not be expected to alter materially the balance of benefits and harms. It is, therefore, of concern that exaggerated claims about side-effect rates with statin therapy may be responsible for its under-use among individuals at increased risk of cardiovascular events. For, whereas the rare cases of myopathy and any muscle-related symptoms that are attributed to statin therapy generally resolve rapidly when treatment is stopped, the heart attacks or strokes that may occur if statin therapy is stopped unnecessarily can be devastating”.

Evidence from large population studies, combined with studies in animals, genetic research and randomised controlled trials had confirmed a causal link between higher levels of low-density lipoprotein cholesterol (LDL-C) in blood and higher risks of cardiovascular disease.

The meta-analyses indicated that for each 1 millimoles per litre (“mmol/L”) reduction in LDL-C the risk of coronary deaths and heart attacks, ischaemic strokes (strokes due to blood clots) and coronary revascularisation procedures is reduced by about 25% during each year (after the first) that statin treatment continues to be taken.

Larger reductions in LDL-C produce larger reductions in the risks of these major vascular events, so that using a statin regimen now available, such as atorvastatin 40mg daily, to reduce LDL-C by 2 mmol/L would approximately halve a patient’s risk of heart attacks and strokes during each year treatment is continued.

The proportional reductions in LDL-C achieved with statins were not materially affected by the starting LDL-C concentration and were similar among different types of patient.

Lowering LDL-C by 2 mmol/L for five years in 10,000 patients would typically prevent major vascular events in 1,000 people with a high risk of heart attacks and stroke, such as patients with pre-existing cardiovascular disease and in 500 people who are at lower risk, for example people at increased risk who have not yet had a vascular event.

The authors were warning that the benefits of statin therapy have been underestimated, and the harms exaggerated because of a failure to acknowledge both the amount of evidence from the randomised controlled trials and the limitations of observational studies.

The randomised controlled trials can determine cause and effect. In randomised trials people differ only randomly from each other so that outcome can be inferred to be causal. Blinding the trial meant unbiased ascertainment. Meta-analyses of large, randomised trials on large numbers of people with different characteristics meant the evidence was widely generalisable. By contrast observational studies compare the health outcomes of large numbers of people who have been given particular treatment by their doctors and people who have not been given the treatment. Although, observational studies may be able to detect large increases in health outcomes that might not have been expected, based on clinical trial data, they are not able to produce reliable evidence about the effects of drug treatments when the health outcomes are common or the effects are modest.

There is an important need for greater public recognition of the limitations of observational studies and anecdotal reports as a source of reliable information about the benefits and a better understanding of the strengths of randomised controlled trials with masked assignment of treatment and systematic assessment of adverse health outcomes.

The public health implications of the failure to recognise the benefits of statins and of the exaggerated claims that have been made about the rates of side-effects are very serious.

“Background Statin therapy has been shown to reduce major vascular events and vascular mortality in a wide range of individuals, but there is uncertainty about its efficacy and safety among older people. We undertook a meta-analysis of data from all large statin trials to compare the effects of statin therapy at different ages.

Methods In this meta-analysis, randomised trials of statin therapy were eligible if they aimed to recruit at least 1000 participants with a scheduled treatment duration of at least 2 years. We analysed individual participant data from 22 trials (n=134,537) and detailed summary data from one trial (n=12,705) of statin therapy versus control, plus individual participant data from five trials of more intensive versus less intensive statin therapy (n=39,612). We subdivided participants into six age groups (55 years or younger, 56–60 years, 61–65 years, 66–70 years, 71–75 years, and older than 75 years). We estimated effects on major vascular events (i.e., major coronary events, strokes, and coronary revascularisations), cause-specific mortality, and cancer incidence as the rate ratio (RR) per 1·0 mmol/L reduction in LDL cholesterol. We compared proportional risk reductions in different age subgroups by use of standard χ2 tests for heterogeneity when there were two groups, or trend when there were more than two groups.

Findings 14,483 (8%) of 186,854 participants in the 28 trials were older than 75 years at randomisation, and the median follow-up duration was 4·9 years. 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. We observed a significant reduction in major vascular events in all age groups. Although proportional reductions in major vascular events diminished slightly with age, this trend was not statistically significant (ptrend=0·06). Overall, statin or more intensive therapy yielded a 24% (RR 0·76, 95% CI 0·73–0·79) proportional reduction in major coronary events per 1·0 mmol/L reduction in LDL cholesterol, and with increasing age, we observed a trend towards smaller proportional risk reductions in major coronary events (ptrend=0·009). We observed a 25% (RR 0·75, 95% CI 0·73-0·78) proportional reduction in the risk of coronary revascularisation procedures with statin therapy or a more intensive statin regimen per 1·0 mmol/L lower LDL cholesterol, which did not differ significantly across age groups (ptrend=0·6). Similarly, the proportional reductions in stroke of any type (RR 0·84, 95% CI 0·80–0·89) did not differ significantly across age groups (ptrend=0·7). After exclusion of four trials which enrolled only patients with heart failure or undergoing renal dialysis (among whom statin therapy has not been shown to be effective), the trend to smaller proportional risk reductions with increasing age persisted for major coronary events (ptrend=0·01), and remained non-significant for major vascular events (ptrend=0·3). The proportional reduction in major vascular events was similar, irrespective of age, among patients with pre-existing vascular disease (ptrend=0·2), but appeared smaller among older than among younger individuals not known to have vascular disease (ptrend=0·05). We found a 12% (RR 0·88, 95% CI 0·85–0·91) proportional reduction in vascular mortality per 1·0 mmol/L reduction in LDL cholesterol, with a trend towards smaller proportional reductions with older age (ptrend=0·004), but this trend did not persist after exclusion of the heart failure or dialysis trials (ptrend=0·2). Statin therapy had no effect at any age on non-vascular mortality, cancer death, or cancer incidence.

Interpretation Statin therapy produces significant reductions in major vascular events irrespective of age, but there is less direct evidence of benefit among patients older than 75 years who do not already have evidence of occlusive vascular disease. This limitation is now being addressed by further trials”.

as Figure 4 – described as “Effects on major vascular events per mmol/L reduction in LDL cholesterol, subdivided by age at randomisation and by previous vascular disease. Data from participants with missing baseline dated included in the totals. RR=rate ratio”:

as Figure 5 – described as “Effects on vascular death per mmol/L reduction in LDL cholesterol, subdivided by age at randomisation”:

Professor Colin Baigent, the deputy director of the University of Oxford’s Clinical Trial Service Unit & Epidemiological Studies Unit (“CTSU”) and a professor of epidemiology (“Professor Baigent”). He specialised in cardiovascular epidemiology, and the design, conduct and interpretation of large-scale randomised trials in cardiovascular disease. He was co-author of The Lancet Review (see [62] above).

Professor Sir Rory Collins, the director of CTSU, British Heart Foundation Professor of Medicine and Epidemiology, Head of the Nuffield Department of Population Health and principal investigator and chief executive of a large-scale biomedical research database, known as UK Biobank (“Professor Collins”). Professor Collins specialised in the establishment of large-scale epidemiological studies of the causes, prevention and treatment of cardiovascular disease. He was the lead author of The Lancet Review. In 2014, Professor Collins had criticised the authors and editor of the BMJ for not withdrawing the 2013 BMJ Articles promptly (see [56] above and [206]-[208] below). He had claimed that the impact on public health of this misinformation was worse than the MMR vaccine scandal.

Professor Peter Sever, Professor of Clinical Pharmacology and Therapeutics at Imperial College London, Honorary Consultant Physician at the Imperial Healthcare NHS Trust, Co-Director of the international Centre for Circulatory Health and an author of scientific studies on statins (“Professor Sever”). He was one of the authors of The Lancet Review.

Professor Liam Smeeth, Professor of Clinical Epidemiology at the London School of Hygiene and Tropical Medicine and a GP (“Professor Smeeth”). He was one of the authors of the LSHTM study and The Lancet Review.

Professor Nilesh Samani, cardiologist and President of the British Heart Foundation (“Professor Samani”).

“… 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”.

Forwarded with the email was the First Claimant’s blog article “Statins in the over 75s” (see [69]-[70] above).

“We can share the finished article with you prior to publication – and we will be doing so with all expert commentators. We want to get this 100% right”.

At 17.23, he emailed Professor Baigent a copy of “Statins in the over 75s” (see [69]-[70] above):

At 17.29, Professor Baigent responded following up two specific issues from the telephone conversation (a) the relationship between low cholesterol and increased risk of death; and (b) mortality reduction in a particular study.

In a separate email, responding to Mr Calman’s forwarding of “Statins in the over 75s”, Professor Baigent said:

“I think it’s fair to say that, as a journalist, my area of expertise, even as someone who does health journalism day in, day out, that complex -- I mean, obviously, I understand about risk ratios and I know what I’m looking at in these tables, but, you know, we would look to experts to tell us, you know, what does this all, you know, mean in practice, am I getting this exactly right, et cetera, and I completely agree that Zoe and anyone is more than within their rights to write their critique of the statistical methods used by the CTT, and they could do so and write to the Lancet also and have their concerns published, as happens, and, you know, there would be an opportunity, at that point, for the authors to respond and say, you know, ‘This is our response to your critique’. This is how science publications work”.

“I think it sums up the – very well summed up the reason that these type of stories – that these kind of ideas catch hold; you know, that it’s not about – it’s not as simple as one false thing, or – it’s certainly not about lying to people, or anything like that. It’s about these mixtures of truth and speculation and opinion to build a picture that’s wrong and misleading, and that reason does sum up. I still think it’s a very good summary of the problem and why these stories are so believable and persuasive. ‘Persuasive’ I think is the word”.

“… He will give the more forcible quotes about the statin denialists (I think he once said that Malhotra was like Andrew Wakefield, just responsible for more deaths), but he often gets criticised for receiving industry funding. He is a serious academic/researcher however, and always happy to talk about statins… Worth chasing up Professor Sir Nilesh Samani from the [British Heart Foundation] as he would give you a quote too”.

“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”.

Mr Calman also forwarded the article to X:

“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…”

“Simple first questions to ask her. Is she ‘cherry picking’ her papers as much as she accuses others of doing?

How does she explain the benefits of statins, ezetimibe and PCSK 9 inhibitors (all of which act solely to reduce LDL levels in various ways) in reducing the risk of a heart attack if LDL is inversely related to heart disease?

What about the evidence that people with genetically very high levels of LDL cholesterol (Familial Hyperlipidaemia) have a dramatically increased risk of heart attacks which can even occur when they are young?

Etc. Etc. The tit for tat could be endless.

Haven’t had a chance to reanalyse the data she is quoting below – but at first sight I’m pretty sure she could be challenged. The correct way as a scientist to challenge data is to do so by writing to the Lancet with these points and allowing the authors of the paper to respond. Has she done this. If the answer was unsatisfactory, she can then reply to that – it’s called healthy scientific debate and we all engage in it. Instead she put out her theory in the ‘discredited’ press….!

The problem with all this is that there is no one cause of heart disease (it is polygenetic and polyfactorial), it appears to be related to a genetic susceptibility and lifetime exposure to risk factors – of which LDL is one. And statins are not a universal panacea – they are merely one of the few and best weapons we have at the moment.

Hope that’s a help … I really am not interested in fighting idealogues online – or in print - and others should be better placed to do this”.

“Thanks. Later today I will send you a note explaining why Harcombe’s reasoning is deeply flawed.

I am copying my colleague Professor Sir Rory Collins, with whom I have worked on the CTT (statins) meta-analysis for many years. Rory will be able to give you a great deal of information, and it would be very important for you to speak to him at an early stage in preparing your article”.

“… By the way, did you see this very recent editorial from the Editors of a very large number of major cardiovascular journals? It would seem to be directly relevant to what I understand are the issues that you are investigating”.

“You may find it helpful to look at the attached Lancet paper [see [62] above], which was led by Rory Collins, as this addresses most of the issues raised by Zoe Harcombe. In particular, the argument that cholesterol is a cause of cardiovascular disease is set out on page 2540 in detail.

A general comment is that the interpretation of epidemiological data requires an awareness of the potential for studies to yield results that – if taken at face value – are misleading, and sometimes even yield the opposite of the truth. As I mentioned when we spoke, and is set out in detail in the attached paper (see, for example pp.2538-9), observational studies are particularly prone to yielding unreliable findings. In any standard course on epidemiology, students are taught ways in which hidden biases provide explanations for why the data appear to be revealing something startling. An understanding of such biases is essential when trying to interpret the findings of studies relating to cholesterol”.

“…The three we have so far are:

Dr Malcolm Kendrick

Dr Aseem Malhotra

Zoe Harcombe

The main focus is their business – all make money from saying statins don’t work.

All have books, journalistic careers, diet plans etc. Do they have companies that publish accounts, how many books have their (sic) sold, do they have books forthcoming, what are the dates of all their book publications, how much do they charge for speaking at gigs etc, do they sell anything else or endorse any other products via their websites, do they live in lavish houses, hobnob with celebrities, etc.

The idea is that they accuse research scientists who publish work on statins as having serious conflicts of interests, because they work for organisations that receive drug company funding.

However, could the same be said of the statins deniers? Do their livelihoods rely on their argument, which, if disproved, would mean they would be out of the job?”.

“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?”

There is no record of Mr Calman receiving a response to this question from Professor Collins.

BC: “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”.

X: “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”.

BC: “Are you able to sum up how we know it does?”

X: “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”.

BC: “So Kendrick is right?”

X: “I’ve never actually read him, mea culpa”

BC: “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”

X: “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…”

BC: “Ok”

X: “I object to the naysayers against statins”

BC: “So it’s bad advice being given by NHS, etc.? “

X: “And I endorse the view that the diet should focus on ‘healthy oils’”

BC: “But no oils are unhealthy?”

X: “And lower carbs”

BC: “Hmmmm”

X: “If you are eating high sat fats, your cholesterol levels – and LDL levels – will be higher than if you are eating high ‘healthy’ fats”

BC: “Rory Collins et al are likening him to Wakefield”

X: “Or carbs”

BC: “But he’s right about the first thing in his book”

X: “But the studies showing this were not at the scale or duration to see if this translated into CHD risk. And if you read [redacted] you will see that I was never in favour of low fat diets!!”

BC: “This is specifically sat fat”

X: “Have you challenged the BHF or Rory to prove that sat fat raises LDL levels (ideally without relying exclusively on Ancel Keys) and moreover to show that it leads to CHD?”

BC: “No. This is supposed to be about how statins deniers are a danger to the public”

X: “I think much of the power of Kendrick – and Harcombe – comes from some laziness on the part of the medical profession. BUT that does NOT mean that statins don’t work. I would equally challenge Kendrick and Co to show that they don’t work in the face of all the evidence that they do!!!”

BC: “But it doesn’t look good for the medical prof. If you are giving non evidence based advice. The NHS is giving fake news in this case”.

X: “It may be – as I often explain to patients – that they work through reducing the likely hood (sic) of rupture of cholesterol – rich plaques rather than simply lowering the concentration of LDL. There is some support for that in the fact that Coronary artery calcium scores continue to rise even when on a statin (? Question of degree of LDL lowering) although the risk of plaque rupture, MI and stents etc. falls. I do honestly think some of the advice given by the NHS on diet may be out of date or lazy. It still doesn’t mean that statins don’t work! Or that they are dangerous”.

BC: “Ok”

X: “There would be room for a balanced discussion or the arguments for and against sat fat in diet – but the evidence that having a lower saturated fat diet which is also low in refined carbs and high in monosat fats is strong. And at the end of the day, that is what the NHS is promoting. The emphasis may be perceived to be wrong – it’s not so much about lowering the sat and carb as raising the good oils without overeating!! Good luck. When are you publishing?”

BC: “So maybe we have to admit they’re right about this”.

BC: “Not for a few weeks”

X: “I always think it’s wise to admit where there are legitimate questions – it makes the real arguments more powerful. But I would still give Rory et al the right to argue their case…!”

at 11.13, he emailed Professors Collins, Sever and Baigent:

at 11.49, Professor Baigent responded:

at 11.50 Professor Collins responded:

at 12:24, Mr Calman forwarded Professor Collins response to X:

at 12:29, Professor Sever responded to Professor Collins email:

at 12.39, Professor Sever suggested that Mr Calman should contact Tom Sanders as a person who would be “good on diet and cholesterol”.

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.

at 13.32, X responded to Mr Calman:

at 13.41, Mr Calman forwarded Mr Clarke’s email and paper to X (without comment).

at 21.11, X emailed Mr Calman:

“Dear all, thank you for your help so far. Everything is shaping up nicely. What would make this piece absolutely staller (sic) is if we could find a case study of someone who had stopped taking statins and suffered a heart attack or stroke. I know it’s a big ask, but it will really bring this entire argument to life. Between you, has anyone come into contact with such a story? Or been contacted by a relative of someone who died, and had stopped taking statins? The piece is set to run next week, so it’s slightly urgent. Let me know your thoughts”.

“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”.

When cross-examined, Mr Calman accepted that the word “inundated” may have been “a bit over the top” and that he had been trying to “rally” the experts to provide case studies.

“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”.

Mr Calman continued to work on identifying the case study that ultimately became “Colin” (see Section F(5) below).

“I read, watched and listened to various materials written and/or published by the Claimants and Dr Malhotra to identify their main claims about statins. From this review, I identified the following as being the most significant challenges made by the Claimants to mainstream scientific opinion as to the benefits and risks of statins:

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;

that statins don’t work and offer no or negligible benefits even to patients at high risk, for example those who have already suffered a heart attack, because preventing [cardiovascular disease] has nothing to do with lowering LDL-C;

that the incidents of side effects was being hushed up and that the true rate was about 20 per cent; and

that the researchers who had conducted the biggest statins studies, in a conspiracy with Big Pharma, had allowed their judgement to be influenced by their financial interests and the evidence they produced was biased and untrustworthy”.

The use of the word “examples” suggests that there may be further material which was considered by Mr Calman prior to publication but which he has not identified. That is not a helpful way to approach an important aspect in a case involving a public interest defence. One would usually expect to find a full list of the documentary material relevant to the issues in the claim, and upon which a party relied, in his/her disclosure list, even if the party no longer has a copy of the relevant document (CPR 31.10(4)(b)).

Some of the materials identified by Mr Calman, if he had read them prior to publication, raised questions as to whether he was being fair to the Claimants in the way that he characterised them – and the overall ‘statin debate’ – in the Articles, and whether he has been cherry-picking the material upon which he has relied. By way of example only, from the Sunday Express article of 2 March 2014 (see Annex 4, Section (B)(2)(i)), Mr Calman has purported to identify only statements attributed to the Second Claimant. The article contains a great deal more by way of context and further information that would potentially have had a bearing on the Articles.

Concerning the First Claimant, there is corroborative contemporaneous evidence demonstrating that Mr Calman had seen and read the following documents, prior to publication of the Articles:

Concerning the Second Claimant, there is corroborative contemporaneous evidence demonstrating that Mr Calman had seen and read the following documents, prior to publication of the Articles:

“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.”

Mr Calman: I believe that you were on statins?

Colin: I was

Mr Calman: But then you stopped taking them because you had heard they weren’t so great.

Colin: I wouldn’t say I heard that they [weren’t] so great, but my experience was I was… on quite a lot of medication, and I couldn’t narrow it down to one or the other and I was feeling lethargic… [The] digestion was changing and everything else. I also spoke with a lot of other people who had gone through a heart attack … who had gone through similar things and they said ‘Oh, I stopped taking my medication a long time ago.’ So I asked them whether they had any detrimental effects, and they said they hadn’t. I’m not one to actually believe everything I read. I’d sooner make my own choice.

Mr Calman: Did you ever read anything negative about them?

Colin: Yeah, it’s out there all the time… And you hear a lot of things on the media. I listen to quite a lot of radio, you get people coming on there speaking about it. And you know yourself when people come on, what they believe is the truth, even though it might not be, and so they can perpetuate quite a lot of untruths going out there when, you know, people believe what they hear. They take that away, and they thing it’s fact then. I’m probably not one of those. I’d like to make my own decisions…

Mr Calman: … was there a something that triggered that moment, was there a conversation or something you heard on the radio or what was it that really triggered that moment where you said, ‘right, I’m just going to stop taking these’?

Colin: I think one thing, after I did the huge hike – well over 2,000 miles unsupported. It felt quite good after that when I got back and I stated to ask myself the question… How much benefit is there in this. Is there a question of – this could be a huge myth with doctors – how much money do they get paid for giving out medicine?

Mr Calman: Where had you heard that…?

Colin: I’ve heard it… Doctors, you know, they have certain… levels that if they can sell, it’s in their interest to. And there’s a lot of medication involved in this, after a heart attack or anything along those lines.

…

Mr Calman: So, you said that… you had heard from doctors. Do you remember was it a doctor on the radio or TV that you had heard that from?

Colin: No, … these are people in the business going out, maybe to a dinner party or something like that, and you say ‘what do you do?’ ‘I’m a doctor’. Whenever I got an opportunity to chat about medication, I used to, to try and learn more. As I say, I never believe anything I hear – when it’s radios, when it’s hearsay, because you don’t really know, but when you’re actually speaking to somebody face to face”.

Mr Calman: Because he’s a cardiologist who speaks a lot on radio, telly, everywhere, … on how statins are --- that doctors are just making money off them, and things that you’ve been saying that make you feel terrible. You don’t remember specifically?

Colin: No, I mean, I might have heard of him on a radio station, I don’t know.

Mr Calman: Or Malcolm Kendrick?

Colin: Again, that name rings a bell-ish. But that would probably be from radio that I just listened to. But I listen to LBC, so if they had been on that

Mr Calman: What would you say to your younger self who said those kind of things that you thought?

Colin: First of all, I think the key phrase is ‘It’s not going to happen to me. Regardless of what I do to myself’. You know… you just fell as though, ‘no, I’ll be all right’. Giving the advice back to myself, I’d say, ‘Regardless of whether anybody’s making money from it or not, whether that’s the truth or not, you’ve got to put your health first’. And… now looking back, I’d say I was a fool to stop taking them. Especially… if you push all the stress to one side, regardless of that, … I should have been back to the doctors, and making appointments and looking after myself.

Mr Calman: You didn’t even tell anyone that you’d stopped taking them?

Colin: Well, I had tried to tell the doctor but I couldn’t get an appointment… They have a chit system, that if you need a repeat prescription… I’d left a message on there saying ‘If you need to contact me about this please do, I’m stopping my medication.’ The system doesn’t help, unfortunately.

Colin went on to suggest that he was rather stubborn and had his “own views”. He had some early problems with his medication, but that had been resolved. He had been taking six or seven tablets a day and he had a concern about the cost.

Mr Calman: … Just going back, do you think… all of these kind of myths or… bad things about medication… they were really affecting your judgment, the things that you had heard and all of that

Colin had not actually mentioned in the interview hearing “myths” or “bad things” about the medication, but, after a pause, he answered:

The remainder of the interview was taken up with discussion of whether Colin would be happy for a photograph of him to be used in the article.

“Yes, but I would say, having interviewed victims of misinformation, that it’s one of the things that people say. People say, ‘I do my own research’ or ‘I make my own mind up’, which kind of means, ‘I’m not going to listen to what doctors say necessarily because I don’t believe them”, and it’s part of that thought process. I think he says, ‘I make my own decisions’ twice, but, clearly, he was believing things that he’d heard, vague perceptions, that, essentially, the drugs didn’t work, and decided -- and, interestingly, it is something I didn’t pick up, that he did this in late 2013, which is the period of debate, but he decided to stop taking statins when he really needed to and then he got ill again”.

“… He was saying that been influenced by things that he had read or heard. Specifically, he was -- I think he says later he’s a big radio listener, and that’s what he was saying the afternoon after he’d had a heart attack, in his hospital bed, in a hospital gown. So, bearing in mind I’m not going to be pushing this guy. But I think he very clearly said to me that the things he heard in the media, it’s all around, ‘You start to believe it, no smoke ...’ I didn’t use ‘the monkey’ analogy. I used ‘no smoke without fire’, to which he said ‘Absolutely, you begin to believe these things’.

Colin had not stated that he had stopped taking statins because he had “heard they don’t really work” ([2]). At best, that can only have been Mr Calman’s interpretation of what Colin had said by way of explanation for why he had ceased taking his medication. As I have explained, there was little in what Colin had said that could have supported such an interpretation. Certainly, attributing this, unequivocally, as Colin’s reason for giving up his medication simply did not fairly represent what Colin had said. He provided several other reasons why he had done so.

The quotations, attributed to Colin in [4] and [10], are both inaccurate. Colin did not say this in his interview. At best, these ‘quotations’ represent Mr Calman’s inaccurate synthesis of the interview. They materially misrepresented the totality of what Colin had said.

“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”.

A similar email was sent, a few minutes later, to Dame Sally Davies, the then Chief Medical Officer for England. Although by this stage, Mr Calman knew that the articles that he would later publish would prominently feature the two Claimants and Dr Malhotra, he did not mention them in the emails to Mr Hancock or Dame Sally.

“… 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…” (emphasis added)

“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”.

Ms Page KC asked Mr Calman whether he had a positive memory of mentioning all three names in his conversation with Ms Hasnain, and he responded: “I am fairly sure that I did mention all the names”. (See further [149]-[151] below).

“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 would note that Mr Calman’s description of the LSHTM Paper, in the second paragraph, was misleading, but if Ms Hasnain had followed the link, she would have seen for herself the parameters of the LSHTM Paper, and its concentration on the 6-month period following publication of the 2013 BMJ Articles.

“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”.

Again, this email gave no indication that the Articles were going to concentrate on three individual “statin deniers”.

“Apologies for the delay, below is Matt’s quote for your piece…

Ms Page KC: “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?”

Mr Calman: “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”.

Ms Page KC: “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?’”

Ms Page KC: “Well, when we see your reaction to it… you say: ‘Thanks all. This is EXACTLY what we’re after.’ It was just what you wanted, wasn’t it?

Mr Calman: “Yes, I think I was clear in our conversation that sometimes you get very anodyne comment from the government on issues, especially controversial ones. You know, we get them all the time. And I think we’d had a conversation about, you know, ‘I think the best thing would be’ -- obviously, you know, a punchy comment would be what we were after, and I think she said, ‘Don’t worry, that’s exactly what we’re going to give you’”.

“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”.

Two minutes later, Mr Hancock responded:

“… 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…”

At 14.14, Mr Calman emailed Ms Wilson, forwarding a copy of his email of 19 February 2019 to Ms Hasnain (see [138] above):

Ms Wilson responded, at 14.36:

Mr Calman replied, at 14.44:

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:

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):

“… 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”.

After referring to his email exchanges with Ms Wilson, he added:

Mr Calman confirmed, in his evidence, that he did not take a note of this call and the Defendants have not relied upon any evidence from the relevant individuals at the Department of Health clarifying what they understood about the article prior to providing the Hancock Statement.

“Whilst Matt Hancock said that he was not intending to single out ‘any one individual’, he was commenting on the issue as a whole on which the DHSC had been briefed as to the claims, and some of the individuals responsible, which the article would address. He did not give a caveat, as many do under such circumstances, such as ‘I cannot comment on an individual case’.

By this point, i.e. on 5 March, I would expect that Matt Hancock would have seen our coverage, seen the way we had used his statements, and seen the way we had presented them alongside references to the Claimants. In spite of this, through his officials he said that he did not want to retract the statements, that he remained supportive, and that we could continue to refer to the statements in follow-up coverage.

There was no suggestion from the DHSC that they wanted or that there was any need for a correction.

I note that the Claimants contend that when I said to the DHSC that the correspondence was with the Managing Editor of [The Mail on Sunday], this was apparently some sort of implicit threat to complain about the matter or ‘expose’ Matt Hancock for not telling the truth in his message to Dr Malhotra. In my email, I said I had involved the Managing Editor because that is what I had done. In the interview Dr Malhotra said our report was ‘misleading, distorted, inaccurate, and defamatory’. These are serious allegations and, had such a complaint be (sic) made – not that one was at the time – then it would have been the Managing Editor who responded. It may well have been that he would have needed to speak with the DHSC, and so it was important to let them know straight away. I also knew that Ms Hasnain did know that we were investigating Dr Malhotra, as we had named him in our correspondence, and so I was seeking a clarification from the DHSC”.

“I don’t see it that way, no. I think it’s really clear that I was – I was very clear – I made it very clear that we were going to name individuals in the piece. I followed that up with an email that named the individuals that I felt were, you know, the most important that they knew and, when the radio show happened, I reforwarded that email”.

“Well, going back to it, I mean, I did say about – I say about the – I mean, talking – I was talking about the statins deniers and I think their ultimate response was that he was talking about clinicians, so here was real clarity, I think, from our conversations, and then from the email which named the individuals, that we were talking about the deniers, individuals, naming individuals. So, yeah”.

“I believe I would likely have said, ‘You probably know’. That’s how I would have put it. The reason that I would have mentioned Zoe Harcombe is because of her involvement with – I think the reason that I would have mentioned Zoe Harcombe would be because of the involvement with the non-governmental – the all-party parliamentary groups and suchlike. She has spoken at those kinds of things”.

“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”.

Mr Calman accepted when giving his evidence that, considering the contents of Ms Wilson’s email of 5 March 2019 (see [146(5)] above), the final sentence of Mr Wellington’s email “may not have been put perfectly”. The email was subsequently sent, in the same terms as the draft, in response to Dr Malhotra.

There is the direct and immediate evidence from Mr Hancock, in response to Dr Malhotra’s message to him, that he was unaware that the Articles would attack individuals (see [144] above). The Defendants do not suggest that Mr Hancock was not telling the truth when he provided this answer. They have not obtained any evidence from him. Had Mr Hancock’s staff been aware that the Articles would target individuals, it is overwhelmingly likely that they would have advised him of this important fact, and they would have warned him of the potential consequences of issuing a statement, in the terms that the Hancock Statement was issued, to be published with the Articles. The risk that Mr Hancock would be seen to be endorsing a very serious attack on the three individuals would have been obvious to any competent media or communications adviser, and one that they would have wanted to avoid.

Of greater significance are the immediate responses, sent by Mr Calman during the afternoon following the TalkRadio broadcast on 5 March 2019. As explored by Ms Page KC in cross-examination, if Mr Calman had effectively communicated to Ms Hasnain, during his telephone call with her, that the Articles were going to feature prominently the three targets as “statin deniers”, the obvious answer to Ms Wilson was to protest strongly that what Mr Hancock had said to Dr Malhotra was flat contrary to what had been discussed with Ms Hasnain in the telephone call. The wording of the email of 18.18, only provides limited support for Mr Calman’s recollection of the telephone call with Ms Hasnain. Even then, had the call been as described by Mr Calman, the emails sent that afternoon would have been in materially different terms. The final sentence of the email at 18.18 is oddly incongruous, and might even be read as some sort of threat. On Mr Calman’s version of the telephone call, Mr Hancock’s message to Dr Malhotra either demonstrated that he was lying or that his staff had completely failed to brief him properly (and had recklessly allowed a statement to go out in his name without his being fully appraised of the important context in which it was likely to appear). Yet, neither of these angles – which were journalistically potentially of interest and significance – was pursued.

The final email from Ms Wilson, on 5 March 2019 (see [146(5)] above, stated clearly that Mr Hancock had provided a “general comment” and was not intended to single out any individual. That effectively confirmed to the Defendants what Mr Hancock had privately told Dr Malhotra. The absence of a note of the conversation between Mr Calman and Ms Wilson, that preceded this email, is odd, as is the failure to respond to the email. If the telephone call between Mr Calman and Ms Hasnain had been as he had described, Ms Wilson’s explanation of Mr Hancock’s message to Dr Malhotra was potentially very important; and the obvious retort to Ms Wilson’s email was that the position adopted on behalf of the Minister was untenable in light of the conversation with Ms Hasnain. No such message was sent.

I do not regard as significant (to the question of what was discussed in the telephone call) the fact that neither the Department of Health nor Mr Hancock sought to take the matter further or issued any public statement in clarification of the reporting of the Hancock Statement in the Articles. On the facts as I have found, this was an embarrassing mistake for the Department of Health to have made. The Hancock Statement had been provided for publication without a proper understanding of the context it was going to appear. That might be thought to be a basic – even elemental – failure in professional media communications. As I have noted already, the Defendants have not provided any evidence from the relevant staff at the Department of Health. It is not necessary for me to make findings as to what went through the minds of those concerned with the Department of Health’s response, and specifically why no public statement was issued confirming what Mr Hancock had stated privately to Dr Malhotra (the substance of which had also been confirmed to Mr Calman in Ms Wilson’s email of 5 March 2019). One possible explanation is that it was decided that to do anything more risked making a bad situation worse. Many factors may have influenced that decision, and it is not necessary for the purposes of this judgment to consider the issue further. The adequacy or appropriateness of the Department of Health’s response is not a matter I need to resolve in this trial.

Q: You told Ms Page in answer to some of her questions that you did not think that the article suggested to readers that the claimants were dishonest and telling lies.

A: No, I don’t think it did. I wanted it not to say that.

Q: Okay. Can I ask you then to look at the article…, page 2 in the newspaper article, paragraph 5. This is the news article:

A: At the time, I just took it as read, and I didn’t question that -- I did have an exchange with Stephen Adams about the issue. I think he’d interpreted that in an earlier draft of the piece and said something along the lines of false claims, and I emailed him, and you’ll see those emails, saying, “We are not suggesting they’re false; it’s that they’re wrong”, or something like -- I don’t have it in front of me. So, within that, that was in my mind, and having spoken to this -- having, you know, been in contact with the legal team, that was what I felt was the due diligence in that respect, and that was really what was utmost in my mind, not changing his statement. I wouldn’t consider changing his statement”.

“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”

Asked to identify where in the Articles it was signalled to readers that the Claimants were not liars, but simply mistaken, Mr Verity pointed to the final sentence of [16] in the Main Article.

“Objective: To quantify how a period of intense media coverage of controversy over the risk:benefit balance of statins affected their use.

Design: Interrupted time series analysis of prospectively collected electronic data from primary care.

Setting: Clinical Practice Research Datalink (CPRD) in the United Kingdom.

Participants: Patients newly eligible for or currently taking statins for primary and secondary cardiovascular disease prevention in each month in January 2011-March 2015.

Main outcome measures: Adjusted odds ratios for starting/stopping taking statins after the media coverage (October 2013-March 2014).

Results: There was no evidence that the period of high media coverage was associated with changes in statin initiation among patients with a high recorded risk score for cardiovascular disease (primary prevention) or a recent cardiovascular event (secondary prevention) (odds ratio 0.99 (95% confidence interval 0.87 to 1.13; P=0.92) and 1.04 (0.92 to 1.18; P=0.54), respectively), though there was a decrease in the overall proportion of patients with a recorded risk score. Patients already taking statins were more likely to stop taking them for both primary and secondary prevention after the high media coverage period (1.11 (1.05 to 1.18; P<0.001) and 1.12 (1.04 to 1.21; P=0.003), respectively). Stratified analyses showed that older patients and those with a longer continuous prescription were more likely to stop taking statins after the media coverage. In post hoc analyses, the increased rates of cessation were no longer observed after six months.

Conclusions: A period of intense public discussion over the risks:benefit balance of statins, covered widely in the media, was followed by a transient rise in the proportion of people who stopped taking statins. This research highlights the potential for widely covered health stories in the lay media to impact on healthcare related behaviour”.

The “exposure period” for the study was media coverage between October 2013 and March 2014. The start date was chosen by the researchers to coincide with publication of the 2013 BMJ Articles. The end date was chosen using a Google trend analytics for the term “statin side effects”. The resulting trial period represented a period of “widespread coverage of the debate over statin side effects across most national media outlets in the UK”.

The study did not involve identification of the particular impact of any individual media report on people who ceased to take statins. The analysis was of overall trends of initiation and cessation of statin therapy. In consequence, the authors noted that it was not possible in the study to confirm a “causal link between the media coverage and observed changes in the likelihood of stopping taking statins”. In other words, the study had not established the link between any media coverage, and any individual’s decision to cease taking statins. Colin, perhaps, stands as an example of how difficult it would be to determine the issue of causality between media reports and a person’s decision to stop taking statin medication, but it was quite clear from the LSHTM Paper that its study did not investigate individual decision-making.

On an assumption of causality, the authors estimated:

The conclusion was:

On 2 February 2016, the authors of the LSHTM Paper submitted the manuscript of the paper for consideration for publication in The BMJ.

On 15 April 2016, Dr Wim Weber, sent the following email to the lead author of the LSHTM Paper accompanied with a note of discussions of the LSHTM Paper at the BMJ’s manuscript committee (the members of which were identified):

The report contained “Additional Questions” about the paper from the following identified “reviewers”: (1) Halava Heli, described as “MD, clinical instructor” at the University of Turku, Finland; (2) Andrea Schaffer, described as “PhD candidate (Pharmacoepidemiology)” at the Centre for Big Data Research in Health, University of New South Wales; (3) Hans Wouters, described as “Postdoctoral Researcher” at the University of Groningen; (4) Cunyet Kocas, described as “MD” at the Cardiology Institute of Istanbul University; and (5) Florence van Hunsel, described as “Coordinator Signal detection” at the Netherlands Pharmacovigilance Centre Lareb . Each of these reviewers declared that s/he (a) had not in the past five years, been employed by an organisation that may in any way gain or lose financially from publication of the paper; and (b) did not hold any stocks or shares in an organisation that may in any way gain or lose financially from publication of the paper.

On 11 May 2016, the authors of the LSHTM Paper submitted their comments in response to the observations of the manuscript committee.

On 22 May 2016, Dr Webber confirmed that the paper had been accepted for publication in The BMJ.

The BMJ’s published policy (from March 2014) on declarations of interests includes the following:

The BMJ is a journal with more than one editor. Dr Weber, who communicated with the authors of the paper and confirmed acceptance for publication, was the “European editor” of The BMJ and acted in that capacity in matters concerning publication of the paper. Members of the manuscript committee also hold the title ‘editor’. For example, Prof Elizabeth Loder MD, the chair of the manuscript committee, held the title “clinical editor”.

Dr Weber, who wrote the letter of acceptance to the authors, was the editor responsible for deciding to publish the LSHTM Paper. Alternatively, the manuscript committee were the editors who were responsible for deciding to publish the LSHTM Paper.

It is evident from the report of the manuscript meeting, sent by Dr Weber and which contained the committee’s detailed comments on the manuscript, that Dr Weber and the other members of the manuscript committee carried out a review of the LSHTM Paper’s scientific merit.

In his observations, Cuneyt Kocas stated that he was the published author of a 2015 study, published in the International Journal of Cardiology, which used “nearly the same method” to study the impact of media coverage on statin adherence. In their response, the authors of the LSHTM Paper stated that they had updated the introduction and discussion to include reference to this “relevant paper”.

In her observations, Florence van Hunsel stated that she had written a report on the impact of the media on cessation of statins in the Netherlands in the British Journal of Clinical Pharmacology in 2009. When published, the LSHTM Paper acknowledged this study.

The BMJ’s published policy on declarations of interest (see [179(6)] above);

the statements from each of the reviewers that they had read and understood this policy and his/her declaration that s/he had no competing interests; and

declarations of interests from four members of the manuscript committee (Elizabeth Loder, Tiago Villanueva, Alison Tonks and Rubin Minhas (and an invited inference that other members would also have been required to complete a similar declaration).

“I was certainly not just going through the motions or ticking a box by sending these right of replies and including responses. I think if you are going to debunk something then you need to ensure that space is given to explore the credence of what they say. I was genuinely looking forward to their responses and hearing what they had to say. Sometimes people come back with information that stops or postpones the publishing of a story, but that didn’t happen here”.

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

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

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

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

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

* You recently blogged: ‘High cholesterol is not even associated with high heart disease, let alone a cause of it.’ This contradicts the aforementioned clinical trials and encourages patients to ignore medical advice to take potentially life-saving medication.

* In a 2014 newsletter you call cardiologists, researchers and bodies involved in statin research ‘statin pushers’ – echoing the term drug pusher, or someone encourages others to take harmful drugs and who makes money supplying those drugs. You appear to justify this by listing those who have received remuneration or funding in some form or another from pharmaceutical companies.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

In evidence, Mr Calman said he was solely responsible for what was contained in the right-to-reply emails. He did not seek either advice or input from anyone else.

Although Mr Calman had willingly shared drafts of the Articles with the Professors with whom he had been working closely, he did not provide the drafts to the Claimants (or Dr Malhotra). As a result, the opportunity that the Claimants had to defend themselves about what was about to be published against them was dependent entirely on what Mr Calman included in the emails sent to them.

Mr Calman did not provide references – or links – to the materials upon which he was relying or asking the Claimants to comment. Indeed, given that the Articles were going to concentrate on the alleged claims of the Claimants regarding statins (that it would be claimed amounted to misinformation), apart from the reference to the Second Claimant’s book, “A Statin Nation”, Mr Calman’s failure to identify the specific claims upon which he intended to rely is particularly striking. As he was giving them less than 24 hours to respond, that was neither helpful nor likely to provide the Claimants with the best opportunity to engage with a process that Mr Calman suggested was the best way to “explore the credence of what they had to say”. As it happens, no doubt due to their familiarity with the subject matter, both Claimants were (with one exception) well able to identify for themselves the material upon which Mr Calman had relied and the materials upon which they wished to rely in response. In contrast to Mr Calman’s approach, both Claimants provided links to the material upon which they relied.

Mr Calman did not identify, by name, those who were criticising the Claimants, instead describing the critics as “one researcher” and “one leading cardiologist”. The decision not to name the Professors was not explained (or explored) in evidence. It may not be the most important point, but one consequence is that it impaired the Claimants’ ability to respond fully to the criticism and it might potentially have deprived Mr Calman of information relevant to his decision to publish (although the Second Claimant, in his response (see [15]), correctly surmised the identity of his accusers). Sometimes, identifying the person making an allegation can lead to the respondent being able to provide information or evidence which undermines the credibility of his/her accuser and/or demonstrates that s/he has “an axe to grind”.

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

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

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

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

[3] If I am wrong, then this statement could, perhaps be true, although it does represent a form of reprehensible bullying – accusing someone of causing many thousands of deaths. This is an accusation that Rory Collins has repeatedly made. He attacked the BMJ for publishing an article suggesting statins may have a high incidence of adverse effects. You may wish to see the e-mail exchange between Rory Collins and Fiona Godlee on this site https://journals.bmj.com/sites/default/files/BMJ/statins/SP13_Emails_between_Rory_Collins_and_Fiona_Godlee.pdf

[4] I would also like to point you to a study published in the BMJ open Kristensen ML, et al. https://bmjopen.bmj.com/content/bmjopen/5/9/e007118.full.pdf

[5] The main findings of this study – not refuted by anyone were 6 studies for primary prevention and 5 for secondary prevention with a follow-up between 2.0 and 6.1 years were identified. Death was postponed between − 5 and 19 days in primary prevention trials and between −10 and 27 days in secondary prevention trials. The median postponement of death for primary and secondary prevention trials were 3.2 and 4.1 days, respectively.

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

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

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

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

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

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

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

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

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

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

[12] Perhaps you would like to read [the 2018 Ravnskov Study – see [215] below] (which I co-authored) ‘LDL-C does not cause cardiovascular disease: a comprehensive review of the current literature.’ https://www.tandfonline.com/doi/pdf/10.1080/17512433.2018.1519391?needAccess=true Which was THE most downloaded paper published by Taylor and Francis in the last year.

[13] Or [the 2016 Ravnskov Study] ‘Lack of an association or an inverse association between low-density-lipoprotein cholesterol and mortality in the elderly: a systematic review’ Published in the BMJ open in 2016 [see [210] below]

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

“I would also point you to this paragraph [of Mr Calman’s email]

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

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

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

[17] I would strongly suggest that you read it in full. It is, in a restrained manner, damning of Rory Collins and the CTT. Here are a couple of sections from that report

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

[19] The conclusions of the BMJ report, which are carefully written are worth considering:

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

Your truly

Dr Malcolm Kendrick

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

“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 (Footnote: ⁴), 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”. (Footnote: ⁵)

[2] Other doctors, academics and researchers have asked for the CTSU/CTT Collaboration data to be shared – including that on serious adverse effects – and it has been consistently refused as “commercially sensitive/confidential”.

[3] The Editor in Chief of the BMJ, Dr Fiona Godlee, has asked for an independent review into the withholding of statin trial data arguing that “no single person or group should have exclusive access to data”. (Footnote: ⁶)

[4] In the absence of access to the CTSU data, we must rely on the independent assessment of all evidence for the efficacy of statins presented in the form of numbers needed to treat (an absolute measure). This reports that, for primary prevention (the majority), for those taking statins for 5 years, no lives will be saved and between 2 and 15 times as many people will be harmed (muscle damage, type 2 diabetes) as helped (avoiding an event). (Footnote: ⁷)

[5] Lives are, of course, never saved. We are all going to die. The measure of interest is – by how much might a life be extended by a particular intervention or drug? This was independently assessed in a non industry-funded paper (Kristensen et al 2015). This paper reported that if someone took a statin for five years (and endured any side effects for that time): “The median postponement of death for primary and secondary prevention trials were 3.2 and 4.1 days, respectively”. (Footnote: ⁸)

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

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

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

[6] ZH comment – I have not written any articles in the BMJ (or any other journal) about statins.

* You recently blogged: ‘High cholesterol is not even associated with high heart disease, let alone a cause of it.’ This contradicts the aforementioned clinical trials and encourages patients to ignore medical advice to take potentially life-saving (ZH comment – no lives will be saved – see above) medication.

[7] ZH comment – this is a fact. High cholesterol is associated with low mortality – from cardiovascular disease (CVD) and deaths from all causes – for all 192 counties in the world.

[8] In 2010, I examined the World Health Organisation data for 192 countries for mean cholesterol levels and deaths from CVD and all-cause mortality for men and women. The relationships turned out to be inverse, for men and women, CVD and all deaths, as shown by these graphs (Footnote: ⁹) [graphs included].

* In a 2014 newsletter you call cardiologists, researchers and bodies involved in statin research ‘statin pushers’ – echoing the term drug pusher, or someone encourages others to take harmful drugs and who makes money supplying those drugs. You appear to justify this by listing those who have received remuneration or funding in some form or another from pharmaceutical companies.

[9] ZH – comment. It would be naïve not to think that sums such as £268 MILLION (payments from pharmaceutical companies to CTSU by 2014) and $149 BILLION (what one statin alone has earned one company) (see below) encourage recipients to aggressively encourage people to take those drugs. Just a couple of weeks ago, the Mail on Sunday front page story argued that climate change chief, John Gummer, should quit over his green business conflicts, which amounted to £600,000. The same Mail on Sunday is now trying to bully little me into silence for blogging about vastly greater sums of conflicts of interest! (Footnote: ¹⁰)

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

[10] ZH comment – any attempt to connect any topic to the MMR vaccine scandal is a deliberate and nasty attempt to smear. Rory Collins heads up the CTSU/CTT Collaboration – the organisation that refuses access to data that could improve patient care. Rory Collins made this association in a deliberate and nasty attempt to smear anyone who even wants to discuss cholesterol and/or statins. (Footnote: ¹¹) He is trying to bully doctors and researchers into silence and the Mail on Sunday is collaborating with this bullying.

[11] Collins tried (and failed) to have two papers withdrawn, which referenced another paper that quantified statin side effects. (Footnote: ¹²) During the investigation into Collins’ demands for retractions it emerged that, as of 2014, the CTSU had received £268 MILLION from the pharmaceutical industry (perhaps the Mail on Sunday could find out how high this figure is now?) (Footnote: ¹³) That’s 268 MILLION reasons to silence debate. The Mail on Sunday should be investigating this Goliath conflict of interest, not a couple of ‘Davids’ who are brave enough to ask questions.

[12] Collins claims that not more than 1 in 50 people will suffer side effects from statins. (Footnote: ¹⁴) The same Collins has a patent that identifies patients at increased risk of myopathy (muscular pain). “The test, branded as 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”. That’s misinformation.

[13] The patient leaflet must be honest, by law, about side effects. The patient leaflet for Lipitor lists common side effects, which may affect up to 1 in 10 people, as: nasal inflammation; nose bleeds; increase in blood sugar levels (google “statins diabetes lawsuit”); gastric problems; joint pain; muscle pain; back pain; abnormal liver function. (Footnote: ¹⁵) This is the harm that Collins wants silenced. Lipitor, by the way, has earned Pfizer, one of the CTSU funders, $149 BILLION by 2016. (Footnote: ¹⁶)

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

[14] ZH comment – whom to trust – the public should trust those who are not earning £MILLIONS and $BILLIONS, while refusing to share invaluable data. Data that could improve patient care.

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

[15] ZH – give me an example?

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

[16] ZH comment – This is a false accusation and I will take further action if you make false accusations. I have examined the entire data provided by the World Health Organisation and found that higher cholesterol is associated with higher deaths, from CVD and all- causes, in men and women, for all 192 countries in the world.

[17] My PhD was an examination of the diet (cholesterol) heart hypothesis. Cholesterol is mentioned 612 times. 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.

[18] I’ll tell you what misinformation is – on 1st February 2019, a paper was published in The Lancet by the CTSU/CTT Collaboration. (Footnote: ¹⁷) A press conference was held to launch the paper. The lead CTSU author, Colin Baigent, was quoted 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 it all took them”. This is false. It relies upon evidence in the over 75s for both deaths and primary prevention and neither was found. Figure 5 of that paper confirmed that the Rate Ratio for deaths in the over 75s was not statistically significant. Figure 4 of that paper confirmed that the Rate Ratio for primary prevention was not statistically significant. I have written to the authors (through The Lancet) asking why they have claimed something that they did not find. I have received no reply. The public should also have been warned that the patient leaflet for statins cautions against people over 70 years old taking them.

[19] Another example of misinformation (in addition to that above on side effects) is the continual use of relative risk numbers to scare people into taking statins. You reiterated this misinformation above “lower heart attack risk by up to 50 percent, and a stroke 30 per cent”. The absolute difference, even for secondary prevention, for those who manage to take statins for 5 years, is 1 in 39 for a heart attack and 1 in 125 for a stroke. Meanwhile 1 in 50 were harmed by developing type 2 diabetes and 1 in 10 were harmed by muscle damage. (Footnote: ¹⁸)

[20] Withheld information is also an issue here. The information being withheld by those running the trials for the pharmaceutical industry is the scandal. Patients are being harmed by not knowing true benefits and true side effects.

[21] The Mail (on Sunday) has always been a bastion for debate – you’re asking the wrong questions of the wrong people on this one.

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

[22] ZH comment – Not least as someone who has freely assisted the Mail/Mail on Sunday with many articles and quotations, I expect to be treated fairly, with balance and not quoted out of context”.

“Context: Studies have demonstrated that statins administered to individuals with risk factors for coronary heart disease (CHD) reduce CHD events. However, many of these studies were too small to assess all-cause mortality or outcomes in important subgroups.

Objective: To determine whether pravastatin compared with usual care reduces all-cause mortality in older, moderately hypercholesterolemic, hypertensive participants with at least 1 additional CHD risk factor.

Design and setting: Multicenter (513 primarily community-based North American clinical centers), randomized, nonblinded trial conducted from 1994 through March 2002 in a subset of participants from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT).

Participants: Ambulatory persons (n = 10 355), aged 55 years or older, with low-density lipoprotein cholesterol (LDL-C) of 120 to 189 mg/dL (100 to 129 mg/dL if known CHD) and triglycerides lower than 350 mg/dL, were randomized to pravastatin (n = 5170) or to usual care (n = 5185). Baseline mean total cholesterol was 224 mg/dL; LDL-C, 146 mg/dL; high-density lipoprotein cholesterol, 48 mg/dL; and triglycerides, 152 mg/dL. Mean age was 66 years, 49% were women, 38% black and 23% Hispanic, 14% had a history of CHD, and 35% had type 2 diabetes.

Intervention: Pravastatin, 40 mg/d, vs usual care.

Main outcome measures: The primary outcome was all-cause mortality, with follow-up for up to 8 years. Secondary outcomes included nonfatal myocardial infarction or fatal CHD (CHD events) combined, cause-specific mortality, and cancer.

Results: Mean follow-up was 4.8 years. During the trial, 32% of usual care participants with and 29% without CHD started taking lipid-lowering drugs. At year 4, total cholesterol levels were reduced by 17% with pravastatin vs 8% with usual care; among the random sample who had LDL-C levels assessed, levels were reduced by 28% with pravastatin vs 11% with usual care. All-cause mortality was similar for the 2 groups (relative risk [RR], 0.99; 95% confidence interval [CI], 0.89-1.11; P =.88), with 6-year mortality rates of 14.9% for pravastatin vs 15.3% with usual care. CHD event rates were not significantly different between the groups (RR, 0.91; 95% CI, 0.79-1.04; P =.16), with 6-year CHD event rates of 9.3% for pravastatin and 10.4% for usual care.

Conclusions: Pravastatin did not reduce either all-cause mortality or CHD significantly when compared with usual care in older participants with well-controlled hypertension and moderately elevated LDL-C. The results may be due to the modest differential in total cholesterol (9.6%) and LDL-C (16.7%) between pravastatin and usual care compared with prior statin trials supporting cardiovascular disease prevention”.

“Statins reduce LDL cholesterol and prevent vascular events, but their net effects in people at low risk of vascular events remain uncertain”.

The interpretation, noted:

“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.

On 30 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 dated 28 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)

On 15 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.’…”

“Zhang et al observed that the rate of statin related events found in their study (18%) was ‘substantially higher than the 5% to 10% usually described in randomized, placebo-controlled, clinical trials.’ Two caveats must be considered. As Zhang et al point out, the rate of statin related events reported in their study was uncontrolled and therefore may be inflated because events attributed to statins might have occurred in a placebo group as well. In addition, although Zhang et al do not make this point, the 5-10% rate quoted by Zhang et al as having been observed in randomised trials was, in many cases, similar in both active and placebo groups.

The exact rate of statin related adverse events in people at low risk of cardiovascular disease remains uncertain. Clinical trials may underestimate the frequency of statin related adverse events because of patient selection, exclusion of older patients and those with comorbid conditions or potential drug interactions, under-representation of women, and selection bias created by willingness to participate in a clinical trial. In addition, when compared with the full clinical study reports, published accounts of clinical trials in medical journals report only a minority of adverse events. Access to the full data from the trials of statins would help to determine the comparative rates of serious adverse events in statin and control groups but probably would not help to determine the frequency of less than serious adverse events.

The authors also mistakenly reported that Zhang et al found that ‘18% of statin treated patients had discontinued therapy (at least temporarily) because of statin related events.’ The correct interpretation of the data, as confirmed to The BMJ by Zhang et al, is as follows. Based on review of structured electronic medical record categories and automated review of unstructured narratives from follow-up visits of 107,835 patients over eight years, 18,778 of all study patients (17.4%) had a statin related event documented during the study. Among those who experienced a statin related event, only 59.2% had statin therapy discontinued at least temporarily. However, because of possible miscategorisation resulting from the limited options in the electronic medical record for recording reasons for discontinuation of statin therapy, Zhang et al concluded that ‘as many as 87%’ of these discontinuations could have been due to statin-related events. This equates to up to 9% of the study population having possibly discontinued statin therapy as a consequence of statin related events, rather than the 18% cited.

The primary finding of Abramson and colleague’s article—that the Cholesterol Treatment Trialists’ data failed to show that statins reduced the overall risk of mortality among people with <20% risk of cardiovascular disease over the next 10 years—was not challenged in the process of communication about this correction.”

“The parties to this latest controversy over the role of statin medication in the primary prevention of cardiovascular disease have different professional backgrounds and experience, which results in different perspectives, interpretations and judgments. Unbiased groups of scientific investigators analysing the same data can reach very different conclusions.

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

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

“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”.

A box, titled “Strengths and limitations of this study”, noted:

“Objective: It is well known that total cholesterol becomes less of a risk factor or not at all for all-cause and cardiovascular (CV) mortality with increasing age, but as little is known as to whether low-density lipoprotein cholesterol (LDL-C), one component of total cholesterol, is associated with mortality in the elderly, we decided to investigate this issue.

Setting, participants and outcome measures: We sought PubMed for cohort studies, where LDL-C had been investigated as a risk factor for all-cause and/or CV mortality in individuals ≥60 years from the general population.

Results: We identified 19 cohort studies including 30 cohorts with a total of 68,094 elderly people, where all-cause mortality was recorded in 28 cohorts and CV mortality in 9 cohorts. Inverse association between all-cause mortality and LDL-C was seen in 16 cohorts (in 14 with statistical significance) representing 92% of the number of participants, where this association was recorded. In the rest, no association was found. In two cohorts, CV mortality was highest in the lowest LDL-C quartile and with statistical significance; in seven cohorts, no association was found.

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). Since elderly people with high LDL-C live as long or longer than those with low LDL-C, our analysis provides reason to question the validity of the cholesterol hypothesis. Moreover, our study provides the rationale for a re-evaluation of guidelines recommending pharmacological reduction of LDL-C in the elderly as a component of cardiovascular disease prevention strategies”.

“… 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.”

“The drug companies must declare known side-effects in patient information leaflets, or they risk jail. 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 data hiders and their conspirators like it or not.

“Statins are back in the news. A review published in the Lancet last week, covered in our news story [link provided], presents what its authors clearly consider to be a definitive account of the evidence on statins that should, they say, bring an end to a dangerous debate.

Not everyone agrees. Though the benefits of statins for secondary prevention or in people at high risk of cardiovascular disease are undisputed, proposals to offer them to large numbers of people at lower risk remain controversial, much to the frustration of the statin trialists who authored the Lancet review. Commenting in The BMJ this week, Harlan Krumholz agrees on the strong case for the overall benefits of statins, but he wants more acknowledgment of the trials’ limitations [link to article]. These include the lack of good evidence in elderly people, the variation in how adverse event data were collected, and the ageing of the trials themselves.

In a BMJ blog Richard Lehman says that adverse effects are much more common than the trials suggest [link provided]. ‘Muscle pain and fatigability are not a figment of misattribution and public misinformation,’ he says. ‘They are too prevalent and recurrent in people who desperately want to stay on statins. Rather than discount a widely observed phenomenon, we should ask why there is such a mismatch with reporting in the trials.’ Could this mismatch be due to exclusion of people who experienced side effects during ‘run-in periods’ before randomisation?

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 [link provided]. 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 (www.bmj.com/content/bmj/suppl/2016/11/09/bmj.i4992.DC1/copedocuments.pdf) that serve to correct Richard Horton’s comments in the Lancet [link provided], in which he wrongly stated that COPE had ‘declined to act’ on Collins’s concerns. (See also my rapid response www.bmj.com/content/351/bmj.h3908/rr-8)

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.

… For more of The BMJ’s content relating to the statins debate go to bmj.com/campaign/statins-open-debate”.

“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.’”

“Introduction: For half a century, a high level of total cholesterol (TC) or low-density lipoprotein cholesterol (LDL-C) has been considered to be the major cause of atherosclerosis and cardiovascular disease (CVD), and statin treatment has been widely promoted for cardiovascular prevention. However, there is an increasing understanding that the mechanisms are more complicated and that statin treatment, in particular when used as primary prevention, is of doubtful benefit.

Areas covered: The authors of three large reviews recently published by statin advocates have attempted to validate the current dogma. This article delineates the serious errors in these three reviews as well as other obvious falsifications of the cholesterol hypothesis.

Expert commentary: Our search for falsifications of the cholesterol hypothesis confirms that it is unable to satisfy any of the Bradford Hill criteria for causality and that the conclusions of the authors of the three reviews are based on misleading statistics, exclusion of unsuccessful trials and by ignoring numerous contradictory observations”.

“… I have received a response from Kendrick to the key points in our article, which I put to him as our duty to offer right of reply. Within that he points to this study [link to the Kristensen Study – see [209] above].

I assume this is evidence that statins don’t add anything much to lifespan.

Can you give me a steer”.

Professor Sever, at 21.12 on 28 Feb 2019, said:

Professor Baigent, at 08.28 on 1 March 2019, said:

“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.’…”

Amongst the changes Mr Calman made following the Claimants’ right-to-reply responses were the insertion of the words in bold.

“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”.

Professor Collins was particularly concerned by the final paragraph of the draft article, which he said was “very disappointing” and ended the article with a repeat of the allegation of potential conflict of interest.

“Rory, I’m not keen to share this more widely than with you and Colin, hence why I’m not copying in all those on your last email. Take a look. We must include their comments, or else the piece will become so unbalanced we could be open to a complaint. That would mean the article could end up completely decimated by lawyers, amended by them, or worse just pulled. The section on their own financial interests remains if you take a look at the spread. Take a look and then lets have a chat on the phone about what you feel needs to change, specifically.

“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”.

Although the potential financial motivation of the two Claimants (and Dr Malhotra) had been in Mr Calman’s mind for some time, “as a main focus” in the Articles (see [90] above), it had not featured in the right-to-reply emails that were sent to the two Claimants as an allegation that would be made in the Articles.

“This is really quite shocking to read.

It really does seem a shame given that you have clearly done a great job getting to grips with the science to let the article be marred by what amount to spurious mudslinging.

At the very least, I would hope it can be made clear that while drug companies have indeed funded trials undertaken by CTSU, neither Colin, Rory or anyone else working for CTSU has received any personal payments from drug companies – this has been a clear, longstanding policy of the CTSU and one that I have admired from afar for many years.

Major randomised trials of drugs that are sufficiently large to provide the rigorous evidence we need are hugely expensive: to be blunt they are frequently way beyond the means of public funders or charities. Drug companies have to foot the bill or the trials would not happen and we would not have the research evidence to guide treatment.

I do hope the article can at least be amended to make these facts clear”.

“You did not send me the initial draft so I cannot comment.

But the current version apparently shows a major shift in the balance of the article to an unwarranted focus on the bad science promoted by Hendricks (sic) and Harcombe.

I thought the whole point of this article was to promote the good science and redress the balance.

I entirely endorse Rory’s comments on the totally unfounded accusations that the reports of the Oxford CTSU were biased and influenced by industry supported funding of the unit.

The integrity of the Oxford researchers is beyond reproach. They are held in the highest esteem by scientists world wide and the insinuations of the likes of Malhotra and Kendrick have gone a long way to undermine public confidence in high quality good science. The comparison with Wakefield and the MMR vaccine is all too obvious.

The way the article now reads seems to give credibility to some of their assertions.

I totally agree that an earlier version (which I have not seen) described by Rory would be far more appropriate and send an undiluted and vitally important message to the public.

“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…”

Mr Calman responded, by email at 20.22 on 1 March 2019:

Mr Adams replied, at 20.38:

“… they wanted to make changes to it because they felt that a certain balance had been ticked (sic), and my job was to try and work out where to draw the line, in the middle of that to make sure that we gave – that it was – it was after the right to replies came in and I inserted lots of the current comments from the Claimants and I think it startled them and, you know it was about finding a balance and, you know, I think I made it very clear to them who was in charge of that situation ultimately and explained to them in very, very simple terms that we must include comment from them or it would not be fair”.

“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”.

I do not accept several aspects of this evidence.

In cross-examination, Mr Calman accepted that he intended the Articles to allege that the Claimants’ public statements had caused people at high risk of heart disease to refuse or abandon statin medication.

Mr Calman understood (and intended) that the Articles went on to allege that the consequence of people refusing or abandoning prescribed statin medication was that they were thereby at significant risk of adverse health outcomes including stroke and heart attack (including death); “illness, disability and death” [12] Editorial. This meaning emerges from the headline and paragraphs [1], [2], [6] of the News Article; the headlines and paragraphs [5], [14]-[16] of the Main Article; and the headline, the case study of Colin, and paragraphs [1], [12], [17] of the Editorial.

Mr Calman understood (and intended) that the Articles also alleged that public statements made by the Claimants about statins were false; they represented “fake health news”. This meaning emerges from the repeated used of the graphic “Fight fake health news”, paragraphs [3]-[5], [7] and the graphic “‘Experts’ behind the scare stories - and why they’re wrong” in the News Article, headlines and paragraphs [12]-[15], and the four sections identifying the “fake news” of the ‘statin deniers’ in paragraphs [19]-[67] of the Main Article, and paragraphs [A], [J], [K] of the Text Box.

I am satisfied that, at the very least, Mr Calman recognised that the Articles could be read as alleging that the Claimants knew that their statements about statins were false. This meaning emerges, most significantly and in my judgment inescapably, from the allegation that the Claimants (and other ‘statin deniers’) were promoting “pernicious lies” (i.e. deliberate falsehoods that had serious consequences). If Mr Calman did not intend to make that allegation, he failed in the presentation of the Articles and his use of language to make that clear, if he had wanted to avoid readers understanding this obvious meaning, he could and should have done so. My conclusion is that, although he had some reticence, in the end Mr Calman was willing for the Articles to be read as alleging that the Claimants were liars.

Finally, I am satisfied that Mr Calman knew that, in the Articles, he was suggesting that the Claimants might have a financial motive to publish information about statins that they knew to be false. The financial interests of the Claimants and Dr Malhotra were set out in the Text Box. Reference is made to the financial motivation in paragraphs [13] and [17] of the Editorial, and the specific question is asked in the final paragraph of the Text Box: “have they just got too much to lose if their arguments are disproved?”.

“Correction & Clarification

In The Mail on Sunday for 3 March 2019 we gave extensive coverage to the subject of statins, both on page 2 of the newspaper and by way of a special report in our Health Section at pages 47 to 50. Our coverage profiled Dr Malcolm Kendrick and Dr Zoë Harcombe PhD, whom we described as ‘statin deniers’. Our article was headlined ‘Statin deniers are putting patients at risk, says Minister’ and our special report was entitled ‘Deadly propaganda of the statin deniers’.

In the course of this coverage we also referred to a statement that had been made to The Mail on Sunday by the Health Secretary, Matt Hancock, on the subject of statins. We attributed to Mr Hancock that he had accused such ‘statin deniers’ and ‘doctors’ of needlessly putting the lives of patients at risk by spreading reckless and ignorant misinformation, and that he had described some of the statements about statins which we had assigned to Dr Kendrick and Dr Harcombe as ‘pernicious lies’.

We wish to clarify that Mr Hancock’s remarks to The Mail on Sunday were not in fact directed by him towards either of Dr Kendrick or Dr Harcombe. Contrary to how we reported his words, Mr Hancock had made no reference to ‘statin deniers’ or to ‘doctors’. Moreover, his reference to ‘pernicious lies’ had not been directed by him to any statements issued by either of Dr Kendrick or Dr Harcombe on the subject of statins, contrary to how we reported the matter.

We are happy to correct the misleading impression given otherwise in our coverage, by way of addressing one aspect of the legal complaints we have received from Dr Kendrick and Dr Harcombe about our coverage”.

“Without prejudice to our client’s contentions as to the applicability of paragraph 7 of Schedule 1 to the Defamation Act 1996 to the statements in question, our client is willing to publish the following statement in accordance with your request for a statement by way of explanation and contradiction:

If your clients agree, our client proposes to publish this statement in the clarifications and corrections column in the next issue of the Mail on Sunday.

A statement will also be published online below the relevant article. Given that it will appear as a footnote to the article, some changes to the above wording are required as follows:

Please confirm that your clients agree to the publication of the above statements”.

“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:

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…”

Publication on matter of public interest

was the statement complained of, or did it form part of, a statement on a matter of public interest? If so,

did the defendant believe that publishing the statement complained of was in the public interest? If so,

was that belief reasonable?

“If the article as a whole concerned a matter of public interest, the next question is whether the inclusion of the defamatory statement was justifiable. The fact that the material was of public interest does not allow the newspaper to drag in damaging allegations which serve no public purpose. They must be part of the story. And the more serious the allegation, the more important it is that it should make a real contribution to the public interest element in the article”.

“By [‘public interest’] we mean matters relating to the public life of the community and those who take part in it, including within the expression public life activities such as the conduct of government and political life, elections … and public administration, but we use the expression more widely than that, to embrace matters such as (for instance) the governance of public bodies, institutions and companies which give rise to a public interest in disclosure, but excluding matters which are personal and private, such that there is no public interest in their disclosure”.

“Editors invoking the public interest will need to demonstrate that they reasonably believed publication - or journalistic activity taken with a view to publication - would both serve, and be proportionate to, the public interest and explain how they reached that decision at the time”.

[122] … as the burden of establishing a public interest defence under s.4 Defamation Act 2013 lies upon the defendant, a defendant seeking to prove that s/he reasonably believed that publishing the statement complained of was in the public interest is likely to find that the prospects of success are enhanced by being able to produce contemporaneous records of the decision(s) taken. Leggatt J’s observations about memory of beliefs being particularly susceptible to decay over time (Gestmin [18]) are likely to be equally relevant in publication cases in which a defendant’s belief that publication was in the public interest is an issue to be resolved.

[123] Defendants seeking to rely upon such a belief - whether in support of a s.4 defence or otherwise - would be well advised to ensure that they are able to demonstrate that they reasonably believed that publication would be in the public interest and how, and with whom, that was established at the time. My confidence that the Court is not setting unrealistic targets is also somewhat fortified by the fact that the current Codes of both IPSO and IMPRESS both impose substantially the same requirements as the old PCC Code of Practice (see [25] above). The IMPRESS Code, particularly, contains a very clear explanation why it is good practice to retain contemporaneous documents that record important decisions about the public interest justification for publication. As an explanation of the importance of contemporaneous documents, it can hardly be bettered.

[124] The Court may ultimately disagree with the journalist’s assessment that it was in the public interest to publish, but contemporaneous documents will at least assist the journalist in being able to demonstrate his/her thought processes at the time. In relevant cases, evidence of that process is also likely to be relevant to, even if not necessarily determinative of, the Court’s assessment of editorial judgment under s.4(4).

(As the Second Defendant is a member of IPSO, the IMPRESS Code has no direct relevance in this case, but its statement of the importance of contemporaneous documents in demonstrating a “audit trail” succinctly explains the point and the effect it has on the cogency of the evidence relied upon to support a public interest defence.)

[112] The importance of giving respect, within reason, to editorial judgment is relevant when considering the tone and content of the material and the nature and degree of the steps taken by way of verification prior to publication: Serafin, Lord Wilson, [60], Flood, Lord Mance, [137], Jameel [2007] 1 AC 359, Lord Hoffmann, [51].

[113] It is important to consider the process and the publication in the round. As Lord Mance noted in Flood, in Bonnick -v- Morris [2003] 1 AC 300 the journalist had fallen short both in not making further inquiries about the anonymous source and in not including the claimant’s explanation, but the Privy Council was “prepared to overlook some respects in which the journalist’s conduct could legitimately be criticised” in reaching an overall judgment as to the availability of the public interest defence ([130]). Lord Mance continued at [131]:

[114] Journalistic freedom covers possible recourse to a degree of exaggeration or even provocation. It is well established that this is something the court must tolerate: Yeo -v- Times Newspapers Ltd [2017] EMLR 1. It is not for the court to substitute its views for those of journalists as to what techniques of reporting should be adopted.

[82] … In Bonnick, Lord Nicholls said at [24] that a journalist should not be penalised for making a wrong decision on a question of meaning on which people might reasonably take different views. But he went on at [25] to say that this “should not be pressed too far”. 

[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”. Yeo was very different from this case. It was a decision on the application of the Reynolds defence to newspaper reports of an undercover journalistic investigation of a leading politician. But I also said (at [175]) that “if the evidential picture is misrepresented or presented in a wholly unbalanced way, that may well be unfair”. Here, the Judge found that the evidential picture had been unreasonably misrepresented.

“… 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:

[134] It is also clear from [Economou [110]], as endorsed by Lord Wilson in Serafin [69], that providing they are not treated as any sort of ‘checklist’, the Reynolds factors will remain potentially relevant when assessing whether a defendant’s belief that publication was in the public interest was objectively reasonable. Lord Wilson traced the legislative history of s.4 through the post-Reynolds authorities in [57] to [59], and observed in [60]:

[135] As Lord Wilson noted ([66]), the Explanatory 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:

[137] The requirement in s.4(3), in cases of neutral reportage, that the Court should disregard any omission by the defendant to take steps to verify the truth of the imputation conveyed by the statement complained of, is an implicit recognition that efforts to verify will usually be regarded as an important factor in the assessment of the reasonableness of a defendant’s belief that publication was in the public interest. That is not to say that a failure to verify will necessarily lead to the s.4 defence being rejected; everything depends upon the particular circumstances of the case. However, recognition of the general importance - outside neutral reportage - of steps taken to verify defamatory allegations is consistent with both domestic and Convention jurisprudence.

[138] In Flood, Lord Phillips explained why neutral reportage justified a journalist being relieved from the normal obligation to verify:

[139] In Axel Springer AG -v- Germany [2012] EMLR 15 [82], the Grand Court held, under the heading “Limits on freedom of expression”:

[140] Similarly, from Times Newspapers Ltd -v- United Kingdom [2009] EMLR 14 (“Loutchansky”):

[141] A key feature of Mr Price QC’s submissions is that the articles were reporting, rather than adopting, the allegations made by Afsana. In the case of the Standard Article, he relies particularly on the fact that there was an express statement at the end of paragraph [4] that the allegations of domestic violence had not been tested in court and were denied by the Claimant. Rightly, he has referred to the well-known statements of principle, from the jurisprudence of the European Court of Human Rights, emphasising the importance in not fettering the media’s ability to report on matters of public interest. By way of recent example from the ECtHR’s decisions, in Ólafsson -v- Iceland (2018) 67 EHRR 19 [56] (with footnotes omitted):

[142] This principle cannot be seen in isolation and needs to be properly understood in the context of Convention jurisprudence (particularly the importance attached, usually, to verifying defamatory allegations recognised in Axel Springer and Loutchansky). Seen in that context, it does not support a contention that, where a publisher is reporting allegations made by others, which can damage the reputation of another, a publisher is relieved of the onus to observe what the ECtHR has referred to as the “ordinary journalistic obligations”: Ólafsson [57]. 

[143] Publishers have at their disposal a variety of reporting techniques. For example, those who are unable or unwilling to take steps to verify defamatory allegations, and who wish potentially to rely upon a public interest defence to defend their publication, may well have to adopt a reporting technique that reduces the overall defamatory impact (for example the inclusion of statements that are effective in indicating that the publisher is not adopting the allegations). Alternatively (where the circumstances permit), the publisher might be able to present the allegations as part of an accurate and impartial account of a dispute to which the claimant was a party. In that latter respect, although the publisher is likely, by reason of s.4(3), thereby to be relieved of the need to take steps to verify the allegations, s/he will nevertheless be required to obtain and publish the other side of the dispute. These are examples to demonstrate the sort of issues that a publisher is likely to have to consider when deciding what technique of reporting is chosen. Difficult questions of judgment may arise, for example, the extent to which it is necessary to include defamatory allegations against others in an article which otherwise makes a significant contribution to a matter of public interest. If a journalist or publisher can demonstrate that s/he has carefully considered the necessity for, and proportionality of, the harm to the reputations of those included in the publication, then a Court is likely to accord due weight to that assessment. Ultimately, in each case where a defendant relies upon a defence under s.4, the Court has to make an assessment of all the circumstances and to make due allowance for proven exercise of editorial judgment.

“… 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.”

Expressions of opinion are likely to be a strong indicator that the statement complained of is or formed part of a statement on a matter of public interest under s.4(1)(a).

It is likely to be a weighty factor in all the circumstances to which the Court must have regard under s.4(2), given that opinion is a particularly strong defence: “The question of whether a statement is factual or opinion can be important. Opinions are easier to defend than factual assertions, as should be the case, given the importance of the free exchange of ideas in a democracy”: Triplark [14] per Warby J.

Attempts to verify a statement of opinion will not be required or possible. All the previous authorities on Reynolds’ and s.4 defences have been cases where the allegation complained of was a statement of fact, not opinion. The judgments in those cases as to the ‘usual’ or ‘normal’ practice of verification, so that the defendant can say that s/he believes the allegation is true, based on verification, is not applicable to a s.4 case where what is sought to be protected is the expression of an opinion. An opinion cannot be verified.

The subjective element of s.4(1)(b) – that the defendant reasonably believed that publication was in the public interest – readily accommodates the subjective test for honesty in s.3(5): that the defendant honestly held the opinion expressed.

The practical and flexible approach to meaning built into Bonnick at least arguably accommodates opinion. Although there would be a tension in the application of these principles since the Bonnick concept of a range of glaringly obvious (alternative) defamatory meanings does not sit comfortably with the subjective nature of honestly holding ‘the opinion’.

The margin of editorial judgement must be greater where an opinion is in play, for the reason that freedom to express opinion is given the strongest protection under both domestic and ECHR law.

I do not accept Ms Evans KC’s first point. A commentator, for example, can express the most vitriolic criticism of a person’s private sexual relationship. The key to determining whether the statement is on a matter of public interest is not how obvious it is that the behaviour is being criticised, but whether the behaviour itself is a matter of public interest.

As to the remaining points, the starting point is that it is clear, from the statute itself, that the honest opinion defence, under s.3, is not being absorbed into the public interest defence in s.4. The law, now on a statutory footing, continues to give generous protection to the honest expression of opinions, subject to the (now statutory) requirements of the defence. Key, for the present argument, is the requirement that the publication must indicate, whether in general or specific terms, the basis of the opinion. The statutory honest opinion defence, like its common law predecessor, provides no shelter either for defamatory bare opinions expressed without premise, or defamatory opinions expressed on facts which are false. If a newspaper publishes an article denouncing someone as unfit to hold public office (expression of opinion) on the basis that s/he is guilty of some discreditable acts (allegation of fact), the focus of any s.4 defence is going to be on whether the publisher reasonably believed it was in the public interest to publish details of the alleged discreditable acts. If the Court finds that it did, then that will protect the publication of the facts relating to the discreditable acts (under s.4) and the expression of opinion based upon them (under s.3(7)(a)). The Court cannot approach the task by looking only at the question whether it was in the public interest honestly to express the opinion. In conclusion, I do not accept that s.4 provides an expansive public interest defence for the expression of opinions, which is subject only to a requirement of subjective honesty.

Whatever the nature of the publication (whether allegation of fact and/or expression of opinion) the test under s.4(1)(b) remains whether the defendant reasonably believed that publishing the statement complained of was in the public interest.

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.

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—

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

…

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

… 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…”

“A copy or fair and accurate report or summary of any notice or other matter issued for the information of the public by or on behalf of any government department, officer of state, local authority or chief officer of police”.

[87] Finally I add these short comments about embellishment and adoption. It is plain that there will be no qualified privilege in an account of Parliamentary speech if the publisher has so embellished the material that it cannot be said to be a fair and accurate report. So much, I think, is shown by this passage from Lord Denning’s speech in Dingle -v- Associated Newspapers Ltd [1964] AC 371, 411:

[88] Some care is I think needed in considering the concept of adoption, discussed by Arden LJ at paragraphs [37]–[40]. In a sense the publisher who embellishes Parliamentary speech may be said to have adopted it: by “putting the meat on the bones” he has made the allegation his own. But I think it is misleading to characterise such a case as one of adoption. Rather than adopting what was said, the publisher has produced a critically different text. Since what he has produced cannot be said to be a fair and accurate report of Parliamentary speech, the law gives him no shield of qualified privilege. That is the whole analysis of the case; no recourse to any such idea as adoption is required.

“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…”

I consider this accurately to state the principles that apply to consideration of s.15(2). In Henry -v- BBC [2005] EWHC 2787 (QB) [91(iii)], Gray J expressed the view (albeit strictly obiter) that, if the publisher has objections to the terms of the claimant’s proposed statement, then s/he should raise them with the claimant and try to reach agreement on the points in issue. For the reasons given by Kirby J, a publisher who is asked to publish any statement or letter by way of explanation or contradiction would be well advised to engage constructively with the putative claimant on the terms of the statement or letter to be published.

[29] The courts in conducting statutory interpretation are “seeking the meaning of the words which Parliament used”: Black-Clawson International Ltd -v- Papierwerke Waldhof-Aschaffenburg AG [1975] AC 591, 613 per Lord Reid of Drem. More recently, Lord Nicholls of Birkenhead stated:

[30] External aids to interpretation therefore must play a secondary role. Explanatory Notes, prepared under the authority of Parliament, may cast light on the meaning of particular statutory provisions. Other sources, such as Law Commission reports, reports of Royal Commissions and advisory committees, and Government White Papers may disclose the background to a statute and assist the court to identify not only the mischief which it addresses but also the purpose of the legislation, thereby assisting a purposive interpretation of a particular statutory provision. The context disclosed by such materials is relevant to assist the court to ascertain the meaning of the statute, whether or not there is ambiguity and uncertainty, and indeed may reveal ambiguity or uncertainty: Bennion, Bailey and Norbury on Statutory Interpretation, 8th ed (2020), para 11.2. But none of these external aids displace the meanings conveyed by the words of a statute that, after consideration of that context, are clear and unambiguous and which do not produce absurdity...

[31] Statutory interpretation involves an objective assessment of the meaning which a reasonable legislature as a body would be seeking to convey in using the statutory words which are being considered. Lord Nicholls, again in Spath Holme, 396, in an important passage stated: 

“The judge approached the words of the paragraph ‘in not a strictly literal sense but in a fairly liberal way,’ to include information painfully extracted by journalists, like a tooth, from an official of a government department acting in the course of his employment, as well as formal statements released to the press by the government department.

That seems to me to pay too little attention to the word ‘issued’ and to the language’s indication that the matter issued must be of the same kind as a notice. It would unduly restrict the words to confine them to written hand-outs, including photographs, sketches or other pictorial representations… but it is right to confine them to official notices and the like, such as, for example, the police message broadcast on television in Boston -v- WS Bagshaw & Sons [1966] 1 WLR 1126, the only reported case on the paragraph: ‘statements of a genuinely official nature formally issued for the information of the public,’ in the words accepted by Jordan CJ considering a statutory provision in similar terms in Campbell -v- Associated Newspapers Ltd (1948) 48 SRNSW 301, 303”.

“It may be right to include in the paragraph’s ambit the kind of answers to telephoned interrogatories which Mr Lord, quite properly in the discharge of his duty to his newspaper, administered to Mr Smith. To exclude them in every case might unduly restrict the freedom of the press and I did not understand Mr Eady to submit the contrary. But information which is put out on the initiative of a government department falls more easily within the paragraph than information pulled out of the mouth of an unwilling officer of the department, and I accept Mr Eady’s argument that not every statement of fact made to a journalist by a press officer of a government department is privileged, and what is certainly outside the privilege is assumption, inference, speculation on the part of the journalist. That is not authorised; that is not official”.

“If the assumption, inference, speculation were the press officer’s, it would not be within the paragraph; Mr. Smith was not speaking on behalf of his department if he told Mr. Lord the reprimanded official was or must have been the plaintiff … A fortiori the reporter’s own assumption, inference, speculation could not be attributed to the press officer’s department. That would be to accord to investigative journalism the protection provided for reporting of official information”.

“Whether the phrase ‘must be Blackshaw’ resulted from the mental process of Mr Lord (as the jury must have found) or that of Mr Smith (as Mr Lord alleged) or was a joint effort between them, it would, it seems to me, be a misuse of words to describe the result as ‘matter issued for the information of the public’. One thing is clear, namely that Mr Smith was not prepared to take responsibility on behalf of the Ministry for giving the name; he was not giving it or purporting to give it on behalf of his department. Not every piece of information given by a spokesman acting in the course of his employment is necessarily information given on behalf of his department”.

“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…”

“Although the information in the statement was supplied in answer to an inquiry from the reporter, it was supplied willingly by the police. Further, it was supplied from the communications room run by the police. It may be inferred the police communications room exists to provide information held by the police to the public. The information is no doubt edited and controlled by the police. One means of disseminating the information to the public is via the media.

[The journalist] rang the police communications room specifically to obtain information about incidents the police were involved in over the weekend. The information was imparted by a person in authority, Senior Sergeant Freeman. The senior sergeant was on duty at the time as the communications senior in the communications room. There is no suggestion that he was not authorised to pass on the information he did to the reporter. In those circumstances, in my view the evidence establishes that the information came from a formal source within the police. The circumstances in which the reporter obtained the information does not defeat the claim to statutory privilege”.

It is a defence to the publication of defamatory matter if the defendant proves that the matter was contained in--

…

In this section,

The letter had not been “issued” by the Minister. Not every document published by a government is per se “issued” by a government: [89]. It was contrary to the ordinary meaning of the word “issued” to characterise disseminating the letter as “issuing it”. The letter did not contain the requisite official character or quality which is common to the other documents defined in s.28(4) (such as reports or papers published by a Parliamentary body; records of the proceeding of a Parliamentary body; judgments, orders or determinations of courts and tribunals; records or other documents open for inspection by the public): [91], [93].

Even if the Minister did “issue” the letter, he did not do so “for the information of the public”, but, for the information of individual customers: [120]. The phrase “the public” clearly means the people or the community as a whole, as distinct from a closed confined class of the community: [114].

The publication of a statement in a scientific or academic journal (whether published in electronic form or otherwise) is privileged if the following conditions are met.

The first condition is that the statement relates to a scientific or academic matter.

The second condition is 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

Where the publication of a statement in a scientific or academic journal is privileged by virtue of subsection (1), the publication in the same journal of any assessment of the statement’s scientific or academic merit is also privileged if—

the assessment was written in the course of that review.

Where the publication of a statement or assessment is privileged by virtue of this section, the publication of a fair and accurate copy of, extract from or summary of the statement or assessment is also privileged.

A publication is not privileged by virtue of this section if it is shown to be made with malice.

…

The reference in subsection (3)(a) 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 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.

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.

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.

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.

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…”

that BMJ Open, the journal in which the LSHTM Paper was published, is “a scientific or academic journal” for the purposes of s.6(1); and

that “the first condition” in s.6(2) is satisfied; the LSHTM Paper relates to “a scientific or academic matter”.

To establish any privilege defence under the section, the required facts must be proved by the defendant (or admitted).

Under s.6(3), a defendant must demonstrate that, prior to publication:

The reporting privilege under s.6(5) requires proof (a) that the underlying statement or assessment was protected by privilege; and (b) that the publication is a fair and accurate copy of, extract from or summary.

A publication is not privileged under the section if the claimant shows that it was made with malice. Malice in this context bears its usual meaning in relation to a defence of qualified privilege (see Section G(5) below).

“What conditions must be satisfied for the review to be ‘independent’ are not defined. Independent of the authors of the paper, or something more rigorous? It is submitted that the latter interpretation is to be preferred if the adjective is to have any meaning, for if it were the former, the adjective need not have been included. Accordingly, scientific and academic journals wishing to take advantage of the defence would be well advised to develop a clear peer-review policy that articulates the basis on which they carry out the process of peer-review and in particular how they ensure that the process is objectively fair, reliable and free from conflicts of interest”.

“Given that one of the persons who is required to carry out an independent review is the editor of the journal, could the other reviewer(s) also be a member(s) of the journal’s staff? It is suggested that what the section is aimed at is an expert review which is independent of the authors of the paper being reviewed…

It was stated in the parliamentary debates that the process of peer review was well understood in the scientific and academic community and that the provisions of the draft section had been shared with the editors of all the key journals who confirmed that the conditions attached were appropriate to ensure that only material subject to a responsible peer-review process would be protected (HL Grand Committee, 15 January 2012, GC 238). The courts will have little difficulty in resolving these questions if the Bill’s sponsors were correct in their assessment of the common understanding of what the process entails and its accurate transposition into legislative terms”.

“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?”

Where the publication of a statement or assessment is privileged by virtue of this section, the publication in the same journal of a fair and accurate copy of, extract from or summary of the statement is also privileged”.

s.6 of the 2013 Act appears in the Act as a self-contained provision on a discrete topic, in accordance with the overall scheme of the Act. The provision describes, primarily in ss.6(1) to (3), the conditions of a privilege, subject to proof of malice, for “[t]he publication of a statement in a scientific or academic journal (whether published in electronic form or otherwise)”. The heading of the section indicates that it is concerned with “Peer-reviewed statement[s] in scientific or academic journal etc”. It is argued that “etc”, in this context, refers to ss.6(4) and 6(5) which provide provisions ancillary to the primary privilege for the publication of peer-reviewed statements in scientific or academic journals. Within the overall structure of the 2013 Act, it is s.7 – not s.6 – which is concerned with general privileges from suit in defamation which anyone and everyone may take advantage of, including of course the press and the media, and which embodies Parliament’s wishes as to extensions to privileges of that kind. It is submitted that in these circumstances one would not naturally expect to find a new, general privilege for anyone in s.6 as opposed to s.7, and that, as a starting point, this is a strong indicator that this is not what Parliament intended to achieve by enacting s.6(5).

The ancillary privilege described in s.6(4) for “the publication in the same journal of any assessment of the statement’s scientific or academic merit” is stated in terms to be parasitic upon the primary privilege provided for in ss.6(1)-(3) for the publication of a peer-reviewed statement in a scientific or academic journal. The s.6(4) privilege arises only “[w]here the publication of a statement in [the same] scientific or academic journal is privileged by virtue of subsection (1)” (emphasis added) and where the assessment in question was produced as part of the peer-review process relating to that statement, namely where “(a) the assessment was written by one or more of the persons who carried out the independent review of the statement; and (b) the assessment was written in the course of that review”.

The second ancillary privilege provided for in s.6, described in s.6(5) as being for “the publication of a fair and accurate copy of, extract from or summary of the statement or assessment” is also parasitic upon and ancillary to (a) the primary privilege provided for in ss.6(1)-(3), and (b), where what is in issue is an “assessment” published in the same journal, the privilege provided for in s.6(4) as well. It is submitted that this observation is a pointer that s.6(5), like s.6(4) (although it does not say so in terms) is and is intended to be concerned exclusively with fair and accurate copies of, extracts from, or summaries of a statement or assessment, published in the same journal. Section 6, considered as a whole, including ss.6(4) and (5), seems to be focussed exclusively on the publication of statements relating to scientific or academic matters in scientific and academic journals following a process of peer-review overseen in relation to a particular statement or assessment by the same editors and reviewers. Against this background, it is submitted that the omission of the words “in the same journal” from s.6(5) appears objectively much more likely to be the product of a wish on the part of the Parliamentary draftsman to avoid repetition and surplusage than of an intention to confer (without fanfare) the privilege described in that subsection on everyone and anyone.

It would be curious, it is argued, if s.6(5) were held to confer a privilege on a newspaper, or some other stranger to the peer-review process, in circumstances where that would require that publisher to satisfy the conditions for a privilege under s.6(1) and, where relevant, the further conditions in s.6(4), when that third party will invariably (a) have had no involvement in the publication of the ex hypothesi peer-reviewed statement or in the process of peer-review which preceded it, and (b) have no direct knowledge of how the peer-review process was carried out, who was involved in it, or how the statement in question came to be published. In whatever way s.6(5) is to be interpreted, there can be no question other than that these are matters which a person who wishes to rely on s.6(5) is required to prove. In this context, the idea that s.6(5) contemplates or intends that a person with no direct knowledge of or access to evidence about the peer-review and publication process should be expected to satisfy these requirements is one that “borders on the absurd”, Ms Page KC submits.

The fifth point is based upon the wording of Paragraph 47 of the Explanatory Notes (see [327] above). It is argued that the use of the phrase “also extends to” in this way reinforces the view that what Parliament intended by s.6(5) was a further ancillary privilege for the publisher of the scientific or academic journal in which the peer-reviewed statement and any assessment of it had been published if it decided also to publish in the same journal a copy, etc. of the statement or assessment, not for anyone one else. If what had been intended was a fresh, free-standing, general privilege for everyone and anyone, one would expect that at the very least this would have been spelled out in the Explanatory Note.

While s.6(5) may not, in express terms, state that it is confined to the publication of a fair and accurate copy, etc. in the same journal, equally it does not say in terms that it extends to the publication of such matter by anyone and everyone. Again, one would have expected Parliament to have stated this explicitly in clear and unambiguous terms if it were the case, especially in the light of s.7 and the provisions affecting the scope of the general privileges in Schedule 1 to the Defamation Act 1996 that it contains.

The proposals that were eventually enacted as s.6 and s.7(9) (Footnote: ²⁰) of the 2013 Act were regarded by the Government as forming two limbs of a policy to increase the protection for scientific and academic speech. However, the two innovations were treated by Parliament as separate matters, the former as a new, sui generis privilege for peer-reviewed statements and the latter as a new, general reporting privilege. For example, Lord Hunt of Chesterton’s proposed Amendment to Clause 6 (which became s.6) was debated at a different sitting in the House of Lords (on a different day) from Amendments 41-42 in relation to the s.7(9) privilege for reports of scientific and academic conferences. Furthermore, while what became s.7(9) had formed part of the Government’s Draft Defamation Bill from the outset, Clause 6 only came into the Bill at the point it entered Parliament, on the recommendation of the Joint Committee on Defamation. In short, from the Government’s point of view, while Clause 7 was always concerned with possible extensions to general privileges for everyone and anyone – most importantly for the press and the media – Clause 6 was wholly and exclusively concerned, consistent with its heading, with “Peer-reviewed statement[s] in scientific or academic journal[s] etc”, nothing else.

Although the Joint Committee on Defamation, was instrumental in the introduction into the Bill of Clause 6, it made no recommendation for a general privilege for the press for the publication of copies of, extracts from or summaries of material they had come across in peer-reviewed journals. It is not even something that was discussed as a possibility. The Joint Committee’s focus was exclusively on the need to protect from suit in defamation scientists and academics publishing in serious scientific and academic journals, the hallmark of which was that they operated a proper system of peer-review. The key paragraph in its Report on this point is [48]:

Lord McNally, in moving the Bill on the Government’s behalf during the debates in the House of Lords, said the following on 15 January 2013 (HL Debate, col. GC238):

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)”. The relevant Explanatory Notes were also unchanged. Nothing was said substantively about Clause 6(5) during the Parliamentary debate. The possibility that the sub-clause might confer a further general privilege on the world at large was not acknowledged.

While it was generally the Government’s purpose in enacting the Defamation Act 2013 to re-balance protection of reputation and freedom of expression in favour of freedom of expression, the Government was distinctly cautious in legislating in the specific context of Clause 6 and was concerned to ensure that the privilege for peer-reviewed publications was kept within proper bounds. It is suggested that this is unsurprising given that the privilege was an entirely novel one. There were also concerns around the clarity and certainty of the language being used and the definition of “peer-review” – as there also were around the term “conference” in Clause 7(9)) – which Parliament decided to leave to the courts to interpret. None of this appears consistent with the idea that Parliament was intending by Clause 6(5) to create a new, general privilege for anyone and everyone, as opposed to an ancillary privilege for the publisher of a peer-reviewed paper, which had overseen the peer-review process itself, and which might wish to publish an abstract or summary of its peer-reviewed paper, whether on the home page of the journal’s website or as part of an editor’s ‘choice’ or ‘round-up’ in addition to the paper itself, or otherwise.

A Joint Committee of both Houses of Parliament was established to consider the Draft Defamation Bill. The Joint Committee heard oral evidence between April and July 2011. The Joint Committee’s Report on the Draft Defamation Bill (HL Paper 203, HC 930-1) did not expressly mention qualified privilege for copies of, extracts from or summaries of peer-reviewed articles. It did contain the following (with footnotes omitted):

On 29 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 Defamation Bill was introduced to the House of Commons and received its first reading on 10 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).

On 12 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):

At the Public Bill committee debate on 26 June 2012, Mr Djanogly said the following regarding Clause 6 (cols. 137-140):

On 12 September 2012, the then Lord Chancellor, Chris Grayling, said the following during the Bill’s third reading (HC Vol. 550, cols. 366-369):

On 15 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’)”. At the end of the debate, Lord McNally, Minister of State at the Ministry of Justice, asked Lord Hunt to withdraw the amendment, because it would “make the defence too widely available”. Lord Hunt did withdraw his amendment. This is the context of the Lord McNally’s speech, relied upon by the Claimants (see [340(3)] above).

In Gatley, the authors state (§17-026):

The authors of Duncan & Neill on Defamation (§18-04) and Blackstone’s Guide (§§7.35-7.39) agree.

“A difficult question may conceivably arise, as to whether publication of a fair and accurate copy of, extract from or summary of the statement or assessment could be privileged under subsection (5), if privilege for publication of the statement or assessment is defeated by malice. Publication of the copy, extract or summary is, by subsection (5), privileged only where publication of the statement or assessment is itself privileged, and by subsection (6), that is not so where publication of the statement or assessment was malicious…

In the case of privilege for fair and accurate copies, extracts and summaries under Schedule to the Defamation Act 1996, malice on the part of the person who made the underlying statement is irrelevant. But it is not a condition of that privilege that publication of the underlying statement should have been privileged.

This situation would have some similarity to that provided for, in relation to the defence of honest opinion, by s.3(6) of the Act. The court may consider that … persons who fairly, accurately and honestly report peer-reviewed statements or assessments from scientific and academic journals should not have to concern themselves with the motives of those involved in the publication in the journal. This could perhaps be achieved by construing the requirement that the underlying statement must be privileged, as meaning privileged in principle, subject to malice”.

“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.”

are the words complained of a fair and accurate extract of the Particulars of Claim?

if so, was the publication by the defendant to the public of the words complained of the publication of matter which was of public concern (now public interest) and for the public benefit, as provided by s.15(3)?

[99] In my judgment s.15 reflects the need to have regard both to the public interest in freedom of expression and to the public interest that an individual's right to his reputation be not interfered with otherwise than for a legitimate aim and when it is proportionate to do so. Parliament has itself carried out the balancing exercise in part. Where a defendant has filed an admission, a non-party has no right to obtain the claim form or particulars of claim, so Sch.1 para.5 will not apply at all. Where a defendant has filed a defence or an acknowledgement of service, then that will necessarily state or imply that the defendant disputes the claim. 

[100] In my judgment it follows that, as a general rule (that is one to which there may be exceptions) it will not be for the public benefit to publish any defamatory allegations made in a claim form or particulars of claim available to the public from the court under CPR r.5.4C without at the same time publishing the fact that the defendant has denied, or is disputing, the allegations, as the case may be. The effect of s.15(3) is to give the court trying a defamation action the power and duty to consider a balancing exercise on the particular facts of the case. In effect in that, and in the predecessor legislation, Parliament has required the court to carry out a balancing exercise similar to the one which has now become familiar under the HRA, namely art.10 and art.8 (see Re S (A Child) (Identification: Restrictions on Publication) [2005] 1 AC 593, Lord Steyn at [17]). 

[101] I find it hard to envisage any circumstances in which there would be a public benefit in publishing defamatory extracts from a claim form or particulars of claim without there being included in the publication a statement that the allegations are disputed, or, if it be the case, denied. It is the very fact that the allegations are disputed or denied that provides the condition, set out in para.5 itself, which gives rise to the legal requirement that the court make the document available to the public. In the present case I see no public interest in ANL publishing a defamatory extract from the … particulars of claim which omitted a statement that the claim is disputed.”

“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.” (emphasis added)

“Therefore, though what is said amounts to a slander, it is privileged, provided the person who utters it is acting bonâ fide, in the sense that he is using the privileged occasion for the proper purpose and is not abusing it. It is sometimes said that he must be acting bonâ fide and not maliciously; but I do not think that that way of expressing the rule is quite exhaustive or correct. I think the question is whether he is using the occasion honestly or abusing it. If a person on such an occasion states what he knows to be untrue, no one ever doubted that he would be abusing the occasion. The jury here appear to have thought that the defendant said what was false knowing it to be false. I cannot agree with that view of the case. If the case depended on a finding to that effect, I should be very loth to find it. But there is a state of mind, short of deliberate falsehood, by reason of which a person may properly be held by a jury to have abused the occasion, and in that sense to have spoken maliciously”.

“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…”

“This species of malice may still have a legitimate role in malicious falsehood claims (particularly trade libel) but it has a dubious justification when advanced in answer to a well-founded plea of qualified privilege. It has been expressly excluded as a basis for proving malice in answer to a fair comment/honest opinion defence: Albert Cheng –v- Paul [2001] EMLR 777. In 2002, Eady J noted that he could not recall an instance of ‘dominant intention’ malice having been proved and described this form of malice as an ‘endangered species’ in relation to qualified privilege: Lillie & Reed –v- Newcastle City Council [2002] EWHC 1600 (QB) [1093]. I am not aware of any such case in the 15 years since.”

(In passing I would note that the period has now grown to 22 years).

[56] … The rationale of the defence of qualified privilege is the law’s recognition that there are circumstances when there is a need, in the public interest, for a particular recipient to receive frank and uninhibited communication of particular information from a particular source: see Reynolds -v- Times Newspapers Ltd [2001] 2 AC 127, 195. Traditionally, these occasions have been described in terms of persons having a duty to perform or an interest to protect in providing the information. If, adopting the traditional formulation for convenience, a person’s dominant motive is not to perform this duty or protect this interest, he is outside the ambit of the defence. For instance, if a former employer includes defamatory statements in an employment reference with the dominant purpose of injuring the former employee, the former employer is misusing the privileged occasion and this will vitiate his defence of qualified privilege. 

[57]  The rationale of the defence of fair comment is different, and is different in a material respect. It is not based on any notion of performance of a duty or protection of an interest. As already noted, its basis is the high importance of protecting and promoting the freedom of comment by everyone at all times on matters of public interest, irrespective of their particular motives. In the nature of things the instances of misuse of privilege highlighted by Lord Diplock (for example, “some private advantage unconnected with the duty or interest which constitutes the reason for the privilege”) are not necessarily applicable to fair comment…”

[49] … Take the case of a politician or a journalist who genuinely believes that a minister is untrustworthy and not fit to hold ministerial office. Facts exist from which an honest person could form that view. The politician or journalist states his view, with the intention of injuring the minister. His reason for doing so was a private grudge, derived from a past insult, actual or supposed. I am far from persuaded that the law should give the minister a remedy. The spiteful publication of a defamatory statement of fact attracts no remedy if the statement is proved to be true. Why should the position be different for the spiteful publication of a defamatory, genuinely held comment based on true fact?

[79] … To summarise, in my view a comment which falls within the objective limits of the defence of fair comment can lose its immunity only by proof that the defendant did not genuinely hold the view he expressed. Honesty of belief is the touchstone. Actuation by spite, animosity, intent to injure, intent to arouse controversy or other motivation, whatever it may be, even if it is the dominant or sole motive, does not of itself defeat the defence. However, proof of such motivation may be evidence, sometimes compelling evidence, from which lack of genuine belief in the view expressed may be inferred. Proof of motivation may also be relevant on other issues in the action, such as damages. 

Where a single article is published, for the purposes of deciding the single natural and ordinary meaning of the publication, the ordinary reasonable reader is taken to have read the entire article (including headlines etc.): Charleston -v- News Group Newspapers Ltd [1995] 2 AC 65, 72F-73D. This principle applies even if the article continues over several pages: Dee -v- Telegraph Media Group Ltd [2010] EMLR 20 [27].

Where several articles are printed in a single edition of a newspaper, the Court must decide whether they were sufficiently closely connected as to be regarded as a single publication. If they are, it does not matter that some readers may have read only some, but not all, of the articles: Dee [29]-[30].

The manner of the presentation of multiple articles may nevertheless be relevant to the assessment of the natural and ordinary meaning, “since [that] is affected by the mode of publication (that is, the relative prominence or emphasis given to what is published) as well as by context”: Dee [30]; Charleston p.74D, per Lord Nicholls.

“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.”

[84] A publication may, and the article in this case does, contain both a fair and accurate report of statements made in Parliament and also comments of the publisher’s own, and the two – as is also here the case – may be readily distinguishable. In those circumstances the repetition rule, which favours the protection of reputations, and qualified privilege, which favours free expression, may be in opposition; and the single meaning rule cannot bridge the gap between them. The court’s approach to a defamation claim relating to the whole publication must in my judgment be as follows:

[85] Thus the hybrid case involves exceptions both to the repetition rule and the single meaning rule, but does so on a principled basis for the reasons I have outlined. 

…

Embellishment and Adoption

[87] Finally I add these short comments about embellishment and adoption. It is plain that there will be no qualified privilege in an account of Parliamentary speech if the publisher has so embellished the material that it cannot be said to be a fair and accurate report. So much, I think, is shown by this passage from Lord Denning’s speech in Dingle -v- Associated Newspapers Ltd [1964] AC 371, 411:

[88] Some care is I think needed in considering the concept of adoption, discussed by Arden LJ at paragraphs 37 – 40. In a sense the publisher who embellishes Parliamentary speech may be said to have adopted it: by “putting the meat on the bones” he has made the allegation his own. But I think it is misleading to characterise such a case as one of adoption. Rather than adopting what was said, the publisher has produced a critically different text. Since what he has produced cannot be said to be a fair and accurate report of Parliamentary speech, the law gives him no shield of qualified privilege. That is the whole analysis of the case; no recourse to any such idea as adoption is required.

[89] In Buchanan -v- Jennings [2005] 1 AC 115 a Member of Parliament effectively re-stated outside Parliament what he had earlier stated inside it. The first statement was absolutely privileged. It could not sensibly be suggested (and was not) that the later utterance was somehow a fair and accurate report of the earlier. Thus the species of qualified privilege which arises in this case did not arise there. Again, no recourse to adoption is needed for the case’s analysis.

[90] In a hybrid case such as this, where there is, first, a fair and accurate report of Parliamentary speech and, secondly, further distinct material, the law is clear: other things being equal the first is subject to qualified privilege and the second is not.

[102] Where, as here, the repetition rule does not apply to the reporting passages, because these are protected by reporting privilege, the publisher is only liable in respect of the comments that have been added to those passages. The meaning of the added comments has, however, to be determined having regard to their context, and the most significant element of that context is likely to be the privileged passages to which the comments are added. If the meaning of the added comments is that the reported allegations are true, then the publisher of the added comments can be said to have ‘adopted the reported allegations as his own’. In those circumstances the publisher will, however, be liable (subject to any defences such as justification or fair comment) in respect only of the added comments. Reporting privilege will still attach to the reporting passages, but because he has adopted them in un-privileged commentary, this will be of little comfort to the publisher.

[103] It follows, on the facts of this case, that the meaning for which the respondent is liable is the meaning to be attached to those portions of the article that are additional to those that reported what Mr Robinson said. The report of what Mr Robinson said is, however, the context in which the additional portions were written and in which the meaning of those portions falls to be determined.

First, the single natural and ordinary meaning governs the parameters of any defence of truth and (to a lesser extent) any defence of honest opinion. If upheld, the effect of any defence is not (retrospectively) to adjust the single meaning but to relieve the defendant for liability for the reputational harm caused by its publication.

Second, together with the extent of publication, it governs the assessment of the objective harm caused to the reputation of the claimant by the relevant publication, which is a key element in the assessment of any award of damages. That objective harm remains the same regardless of whether the publication (or any part of it) is protected by privilege (or any other defence). If some, but not all, of a defamatory publication is found to be privileged, the damages may be reduced: Dingle -v- Associated Newspapers Ltd [1964] AC 371, 394 (per Lord Radcliffe), 410 (per Lord Denning), 414 (per Lord Morris)

the “Print Publication” consists of the publication, in the hardcopy of The Mail on Sunday of the News Article, the Main Article (including the Text Box) and the Editorial;

“Online Publication 1” is a single continuous page on Mail Online, on which the three Articles were published together – Main Article (minus the Text Box), News Article and Editorial;

“Online Publication 2” is a separate page on Mail Online, on which the News Article was published, but with a hyperlink to the Main Article; and

“Online Publication 3” is a further separate page on Mail Online, on which the Editorial alone was published.

Mr Calman carried out such checks and made such inquiries as it was reasonable to expect of a journalist in his position, investigating and writing about this subject matter (i.e. the rival contentions as to the existence, reliability, strength, conclusiveness etc., of scientific evidence drawn from the studies into statin use).

This would include Mr Calman satisfying himself of the accuracy of certain facts, namely:

However, “the secondary evaluative/comparative inferences themselves, i.e. with what reliability/confidence/solidity are the rival scientific opinions of established experts and the Claimants held (‘definitive’/’indisputable’ etc.) could not be verified”.

“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”

This was a controversial subject, upon which it was obvious to Mr Calman that there were competing views. There was a longstanding, and ongoing, public dispute about the benefits of statins, particularly when measured against potential side-effects; the ‘statin debate’. Mr Calman had, himself, described it as a “row” (see [97] above). As stated in the BMJ Review Report (see [206] above): “Unbiased groups of scientific investigators analysing the same data can reach very different conclusions”. As Mr Calman noted in the Editorial ([12]), and similarly accepted in his evidence, “Debate should – must – be at the heart of science”, and at an early stage of his research, Mr Calman had been specifically advised by X, in the context of the statin debate, “that there is no one cause of heart disease, … statins are not a universal panacea – they are merely one of the few and best weapons we have at the moment”, and that it was “wise to admit where there are legitimate questions” (see [85] and [94] above).

There were two main sides to the statin debate, as Mr Calman well understood. On the side of “scientific consensus” or orthodoxy, were included the experts with whom he had worked closely and relied upon in preparing the Articles. Mr Calman expressly recognised that his experts were on one side of “the row” (see [97] above). On the side of the critics, were the Claimants, but importantly others. On 12 February 2019, X had warned Mr Calman that the First Claimant “cherry picks as much as the other side”, that Professor Collins was “as outspoken as she is” and the “tit for tat could be endless” (see [84]-[85] above).

Put neutrally, the Claimants, in their published works and other public statements, had raised questions about whether the medical orthodoxy on statins was correct. In doing so, they had identified and relied upon several scientific studies published in peer-reviewed journals and (for the First Claimant) had drawn upon her own research and (for the Second Claimant) his experience as a GP. Although the weight to be attached to any particular scientific study or trial might be a matter of debate, it has not been suggested that any of the papers upon which they relied (save in respect of some of the conclusions of the 2013 BMJ Articles) are not serious contributions to scientific learning and debate on statins published by reputable academic journals.

A proper understanding, assessment and presentation of the claims and counterclaims made in the statin debate required an understanding of a large number of scientific papers that had been published on the topic which, in turn, required familiarity with the terminology and concepts used as well as statistical methods and analysis.

Arising from Mr Calman’s close working relationship he had with the experts whilst preparing the Articles, and the privileged status he had granted them to review the main articles prior to publication, there was an obvious risk that they might seek to exercise a disproportionate influence over the editorial decision-making and ultimate terms in which the Articles were published. Put shortly, as they represented one side of the debate (or “row”, as he described it to X) there was a clear risk that they had “an axe to grind”; a risk that they would want to see the Claimants (and others) publicly discredited. This risk was not fanciful, as Mr Calman must have appreciated. From the material he had prior to publication, it would have been apparent that there was an ongoing public dispute about statins of which his experts represented only one side. That should have been apparent to Mr Calman at least from the terms of the BMJ Review Report (to which both Claimants had specifically directed to Mr Calman’s attention) following Professor Collins’ demands, in 2013 and 2014, that the 2013 BMJ Articles should be withdrawn and that the journal should publish a statement that the claims about side-effects of statins were “wrong”.

Given that Mr Calman was inviting readers to make up their own minds, it was imperative that he gave the Claimants a fair and proper opportunity to respond to the points upon which he intended to criticise them in the Articles and that, in the published Articles, he faithfully represented what the Claimants had said in their own defence, and any other matters of which Mr Calman was aware that could fairly be regarded as having a bearing on the merits of the statin debate as they were to be presented to readers.