The white paper was focused on \u201cfour primary allegations\u201d, which it claimed had been proposed to discredit Keys and which it claimed were wrong. Part 1 of the review of The True Health Initiative paper<\/a> found that only one part of one of four allegations \u2013 the confusion between the Mount Sinai presentation six countries graph and the seven countries study \u2013 is commonly made in error. The rest was much ado about nothing, as Shakespeare would say.<\/p>\n In this second part, I will present the criticisms of the Seven Countries Study (SCS) that the white paper should have made. There are many limitations of the Seven Countries Study. I will cover the six most damning. The first issue alone renders the SCS redundant. (If you would rather watch a video to tell this story, here\u2019s one from February 2017<\/a> on this very topic).<\/p>\n 1) The SCS is an epidemiological study. <\/strong><\/p>\n The SCS might be of interest if there were not Randomised Controlled Trials (RCTs) and, better still, systematic reviews and meta-analyses of RCTs, examining dietary fat and heart disease. But there are: many of each. At the time the dietary guidelines were introduced (1977 US\/1983 UK) there were five RCTs available for the US authorities to consider (Refs 1-5) and a sixth was available to the UK committee (Ref 6).<\/p>\n Individually, none of these RCTs recommended that dietary guidelines should be introduced. On the contrary, only one study made a positive claim for its intervention after five years (Ref 7) and subsequently, this was moderated (Ref 4). Rose et al<\/em> (Ref 1) warned of possible harm by administering corn oil. The Research Committee concluded \u201cA low-fat diet has no place in the treatment of myocardial infarction<\/em>\u201d (p504) (Ref 2). The MRC Soya-bean oil intervention found no evidence that MI relapse would be materially affected by unsaturated fat in the diet (Ref 3). The LA Veterans study reported that total longevity was not affected and expressed concern about unknown toxicity of their intervention (Ref 5). Woodhill et al<\/em> noted that survival was significantly better in the control than the diet group (Ref 6).<\/p>\n Collectively, in meta-analysis, these RCTs found that dietary interventions made no difference to deaths from Coronary Heart Disease (CHD) or deaths from any cause (Ref 8).<\/p>\n If we generously ignore the fact that the dietary fat guidelines had no RCT evidence base at the time they were introduced, but see if they would be justified now with evidence currently available, I found that they would not be (Ref 9). Others have found similarly. A number of meta-analyses of RCTs, examining dietary fat and mortality, have been undertaken by other authors (Refs 10-13). A meta-analysis of prospective cohort studies has been undertaken by other authors, Siri-Tarino et al<\/em> (2010) (Ref 14). Two additional meta-analyses reviewed both RCTs and prospective cohort studies (Refs 15, 16).<\/p>\n Table 7.1 in this paper (on open view) (Ref 17) summarised the findings from these other meta-analyses of RCTs and\/or prospective cohort studies. There were 39 reports of risk ratios from meta-analysis with 95% confidence intervals. Of these, 4 reported significant findings; 35 reported no significant findings. That is important in itself. 35 out of 39 findings from 8 meta-analyses (Refs 8 and 10-16) found nothing statistically significant in an examination of dietary fat RCTs and\/or cohort studies.<\/p>\n<\/p>\n \n The four significant findings were:<\/p>\n i) Chowdhury et al<\/em> found that trans fat intake was positively associated with coronary disease (Ref 16). I\u2019m not surprised. Having examined the evidence between coronary disease and fatty acids \u2013 including saturated, monounsaturated, polyunsaturated and trans fats, while also reviewing individual chain length fatty acids, palmitic (C16:0) and margaric (C17:0) \u2013 Chowdhury et al\u2019s<\/em> conclusion was \u201cCurrent evidence does not clearly support cardiovascular guidelines that encourage high consumption of polyunsaturated fatty acids and low consumption of total saturated fats<\/em>\u201d (p398) (Ref 16).<\/p>\n ii) Mozaffarian et al<\/em> reviewed the impact of replacing saturated fat with polyunsaturated fat (Ref 12). This study was criticised by Ravnskov et al<\/em> (including me) (Ref 18) for excluding two studies that would have moderated this conclusion \u2013 the Rose Corn oil trial (Ref 1) and the Sydney Diet Heart Study (Ref 6) \u2013 and for including a favourable, but non-randomised, non-controlled, cross-over, trial excluded by robust meta-analyses \u2013 the Finnish Mental Hospital Study (Ref 19). Interestingly, the recent American Heart Association \u2018Presidential Advisory\u2019 paper (Ref 20), also unfairly excluded the Rose Corn oil trial (Ref 1) and the Sydney Diet Heart Study (Ref 6) and also unfairly included the Finnish Mental Hospital Study (Ref 19) and funnily enough reached the same biased conclusion as Mozaffarian et al.<\/em><\/p>\n iii) & iv) The other two significant findings were related to cardiovascular disease (CVD) events and not mortality (Refs 11, 13). In 2011, including RCTs with a minimum of 6 months duration, Hooper et al<\/em> (Cochrane review) found 1 significant result and 11 non-significant results. The one significant result was that, when all RCTs were examined together, the risk ratio (RR) for CVD events from meta-analysis was 0.86 (95% CI 0.77 to 0.96). In 2015, including RCTs with a minimum of 24 months duration, Hooper et al<\/em> found one significant result and seven non-significant results. The one significant result was that, when a reduction in saturated fat was examined, the risk ratio (RR) for CVD events from meta-analysis was 0.83 (95% CI 0.72 to 0.96).<\/p>\n As a result of this 2015 review (an update of the 2011 review), Hooper et al<\/em> suggested that there may be a small reduction in cardiovascular risk with reduction of saturated fat intake (Ref 13). It was further suggested that replacing the energy from saturated fat with polyunsaturated fat \u201cappears to be a useful strategy, and replacement with carbohydrate appears less useful<\/em>\u201d (p2) (Ref 13) and replacement with monounsaturated fat unclear. However, of the 11 interventions contributing to this conclusion, only 1 documented both saturated fat reduction and reported that this was mainly replaced with polyunsaturated fat (Ref 5).<\/p>\n This prompts the question \u2013 why would Hooper et al<\/em> have found even one significant result (among many non-significant results) that other researchers didn\u2019t? The Hooper et al<\/em> meta-analyses of 2011 and 2015 included four small studies (646 people in total), not included in other meta-analyses, which were primarily studies of: diabetes (Ref 21); skin cancer (Ref 22); hypercholesterolemia (Ref 23); and glucose intolerance (Ref 24), but for which Hooper et al<\/em> obtained CVD event information from correspondence with authors. This non-published data was also, therefore, not peer reviewed. Some of it required only a cursory examination to establish that it was nutritionally unsound: Houtsmuller described the intervention diet as \u201ccarbohydrates 50 cal%, saturated fats 35 cal% and proteins 15 cal%<\/em>\u201d (Ref 21). As there is no food containing saturated fat without unsaturated fat, this diet cannot exist.<\/p>\n Notwithstanding that Hooper et al<\/em> reached a conclusion using non peer reviewed, non robust data… Notwithstanding that Hooper et al <\/em>reported a finding about replacing saturated fat with polyunsaturated fat, when only one study had actually done this… (and did not recommend dietary change)… when Hooper et al<\/em> subjected their one significant finding (for CVD events) to the required sensitivity analysis, even this one finding ceased to be statistically significant (Table 8, p121) (Ref 13), leaving no genuine significant findings. (I always credit Dr Trudi Deakin for alerting me to this point).<\/p>\n For the final nail in the Hooper et al<\/em> coffin, the most recent review (2015) (Ref 13) included no study of healthy people of both genders. The one primary, both-sex RCT available was excluded by Hooper et al<\/em>, for not meeting the 24 month duration criteria (Ref 25). Even if the one claim of a small benefit for CVD events had been robust, this had no \u201cgeneralisability\u201d and thus could not be applied to people from the general population. i.e. you and me.<\/p>\n It is worth remembering that dietary fat guidelines were introduced with the ambition of reducing deaths from CHD. No meta-analysis of RCTs and\/or prospective cohort studies has found any significant difference for dietary fat interventions and all-cause mortality or deaths from CHD, or associations with dietary fat and CHD mortality (Refs 8 and 10-16).<\/p>\n 2) The SCS contradicted contemporary epidemiological and RCT evidence. <\/strong><\/p>\n In Part 1 of the review of The True Heath Initiative white paper, in the \u201cIn Addition\u201d section, I quoted an extract from p5 of the white paper: \u201cUltimately, SCS suggested a link between dietary intake, specifically saturated fat, and heart disease. This conclusion, which corroborated other clinical and epidemiological evidence at the time, generated numerous hypotheses and has since inspired countless clinical trials.\u201d<\/em><\/p>\n I said that this was not correct: \u201cThe finding between saturated fat intake and heart disease was\u00a0not<\/em>\u00a0replicated by other clinical\u00a0or<\/em>\u00a0epidemiological evidence at the time\u201d (Refs 8, 26). The RCT evidence has been presented above. The six RCTs at the time neither individually, nor collectively, corroborated the SCS finding; quite the opposite.<\/p>\n Turning to epidemiological evidence, the six epidemiological studies of the time were: The Western Electric Study (Ref 27); The Seven Countries Study (Ref 28); a study conducted in London and the South East (Ref 29); The Framingham Heart Study (Ref 30); The Honolulu Heart Program (Ref 31); and The Puerto Rico Heart Health Program (Ref 32). The systematic review of these six epidemiological studies was an original publication from my Ph.D. (Ref 26). The summary table of evidence from the six studies is below:<\/p>\n Table 1 Outcome data from included prospective cohort studies for: study name; participant number and age range; years of follow-up; total fat and saturated fat for CHD-free vs. CHD deaths (Refs 30-32) or CHD-free vs. development of CHD (Refs 27-29); and other significant associations found.<\/p>\n![](\"http:\/\/zoeharcombe.co.uk\/2017\/assets\/GuestSignupZH.png\")
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