Prof. Tim Noakes - 'Hiding Unhealthy Heart Outcomes in Low-Fat Diet Trials'

[Music] well hello low-carb friends it's a great privilege to be able to share my lecture with you and thank you paul for inviting me i hope you're having a fabulous conference and again thank you for inviting me so my topic is going to be hiding unhealthy heart outcomes in low-fat diet trials so a lot of people have observed that the science of the low-carbohydrate diets the long-term studies are often distorted the evidence that is given but i've had a long-term interest in the women's health initiative and i'll explain why as we go along and so this is about the women's health initiative randomized controlled dietary modification trial and the data manipulations and the way the story has been distorted because this is the largest trial ever undertaken the most expensive 700 million dollars and you can as i will show you the outcome is quite different to what has been projected and as i've indicated i have a special interest because one of the people who are the premier investigators comes from my university here in cape town and we were involved in a debate at the university for various reasons at the time that i got into trouble for starting to promote the low carbohydrate diet and he was sent out specifically to quieten and to shut me down so that's the bias that i have and i bring to it but it also brought a lens of focus onto the study to see what was really happening so many of you will know that i was promoting a high carbohydrate low-fat diet for 33 years and then i was fortunately came across the new atkins for a new you i purchased the book and within three hours i realized that i'd been wrong for 33 years and i decided to change and of course i read all the other books i read dr atkins's diet revolution but of course i'd been taught that that dr acton's was trying to kill all of us because he was telling us to eat a high saturated fat diet and the women's health initiative was in part designed to disprove atkins and that's a really important point it wasn't designed to to help promote the low carb movement it was definitely designed to prove that the dietary guidelines that were introduced in 1977 were appropriate but why would why was this study initiated 20 years later to study what had already been decided it was there was bias already there it was going to be very difficult for the scientists to come up and say actually what the women health what the women's health initiative shows is that the dietary guidelines we've got are wrong so i then wrote this book with these three co-authors and my contribution was simply a chapter on insulin resistance and diabetes and there i wrote but perhaps more important is the idea that insulin resistance is the hidden metabolic abnormality underlying many of the chronic diseases reaching epidemic proportions in modern humans and which includes obesity type 2 diabetes high blood pressure high blood cholesterol concentrations and heart disease so i wrote that in 2013 2012 2013 and i'm glad to say obviously all of you know that that's essentially correct but this caused me enormous problems and my career changed as a consequence as we'll discuss and i further wrote this suggests that despite its remarkable effects in morbid obesity banting that's what we call the low carbohydrate diet in south africa and that term banting was introduced by this book should be considered as a treatment option to cure type 2 diabetes mellitus hypertension and elevated blood cholesterol concentrations in some without the need for lifelong medication this is important since modern pharmacological agents can cure none of these conditions and of course writing that was sealed my fate because what i'm suggesting there is that diet could replace pharmaceutical interventions and unfortunately industry doesn't like to hear that so as i said when i wrote that i was at the university of cape town i'd been there for something like 45 years as a student and as a lecturer but having written that caused all sorts of problems for me and one of the first indicators i had that i was in trouble was that i was invited to produ to participate in a thing called the centenary debate so the university centenary they decided that i should debate the chief and the chief is professor rosso who was one of the key drivers of the 700 million women's health initiative randomized controlled dietary modification trial which ran from 1993 to 2005 but which i'll show the data continue to be analyzed up to 2019 so we're going to look at some of the papers coming out of this the study right up to 2019 so his his reason for coming to south africa was to destroy me and to make sure that i would know and listen to me forever so the debate was quite important in my career and eventually it was published and this is what he wrote what professor rosso argued and you'll see that he is promoting serum cholesterol as a risk factor for coronary heart disease and he wrote ldl cholesterol is more than a risk marker it's also a causal risk factor as demonstrated by genetic studies and clinical trials well we debunked that story i think in the last low carb conference that was organized by paul last year and what's a causal risk factor it's either causal or it's not and i spoke about causation and cholesterol has never been shown to be the cause of heart disease so that was his one statement and then he wrote the diet heart hypothesis obesity and diabetes and this is what he wrote in this is written in 2014 and remember that the women's health initiative starts in 1990 and the first publication is 2006. unfortunately no definitive clinical trial has tested the dietary hypothesis well what did the women's health initiative do i mean you were the chief of it how can you come along and say it so what part of the argument became that actually this wasn't a clinical trial of diet and it's quite true there were many other components to the study but the one key driver was that these women who were on the trial were were put on a particular diet they're advised to eat the start they were given monthly interviews and discussions group discussions about how they should change their diet is that not a dietary intervention well the answer is no because if you don't get the right answer you suddenly say it's not a definitive clinical trial and then he continues and we're going to come back to this as the very final slide so it's quite important there's a long term experience of the safety and benefits of the american heart association vegetarian mediterranean diets for weight maintenance but that's not true the weight maintenance studies don't look at safety they just see look at how much weight you lose they're not safety trials and they're not long-term studies they're usually two two years and then he says there's no similar long-term experience of the safety of the more extreme low carbohydrate high-fat diets well there is there are data as everyone knows for more than two years and then he this was the target this was directed at me this next statement in the absence of such evidence we would do well to heed the advice of hippocrates i will apply dietetic measures for the benefit of the sick according to my ability and judgment i will keep them from harm and injustice sometimes interpreters as premium non-negari first do no harm so the question is what happens if he does a study which discovers that they do harm what would his response be what should it be and that's the question we'll try to address so in my presentation i said cholesterol is not an important risk factor for heart disease and the current dietary recommendation do more hot than good and i said in summary these data show that the total blood cholesterol concentration is a poor predictor of future heart attack risk confirming that quote cholesterol is not an important risk factor for heart disease and then i rate again remember this is 2013 2014 that i would have written this instead both diabetes and metabolic syndrome which are disorders of carbohydrate not fat metabolism are the single most important risk factors for a heart attack what is it about diabetes and metabolic syndrome that makes them so dangerous so those are the two arguments we presented and basically we might as well have not had the debate because it didn't change anything however interestingly another person at the university of cape town started writing blogs about me isn't it north korea of epistemology and then he even went so far as to say that uh that i'd abandoned the domain of rigorous scientific methodology steady steady reasoning and hard evidence for hyperbole and anecdotes in order to prove his low carbohydrate high fat theory and he further said nox is encouraging incompetent and pseudoscientific thinking on matters of science and encouraging a cultish adherence to a model that hasn't yet been scrutinized in full and for which we have no long-term data this is irresponsible and an abrogation of his responsibility as a scientist and an educator and you can see this gentleman's name is rousseau but it's spelled differently than the answer is this is the son of the chief so it was really interesting that the chief came to cape town and we had this debate and his son then became the leader of part of the academic online bullying to which i was exposed so we covered all of this in these books the law of nutrition and real food on trial and i don't need to discuss them any greater length if you want to know the full story of what happened to me and then my son completed his phd and in on media studies and then decided to look at academic online bullying and use my case to define exactly what is online academic bullying which had never been described before in which he has developed the diagnostic criteria but this was all part of the actions against me so now let's move on to the women's health initiative study and and there's the study and it starts with 48 000 post-menopausal women they're randomized to two groups the one group are assigned to a low-fat eating pattern notice it's not a replacement of saturated fat with polyunsaturated fat they were asked to replace saturated fat with carbohydrates and 60 continued to continue with their own diets and these the new diet for the group that were on the intervention subjects reduced energy from fat between 20 and from saturated fat to 7 by increasing fruit and vegetable intake etc whereas the poor control group were just given a copy of the dietary guidelines for americans as well as other healthy material but had no contact with nutritional interventionists whereas a group on the left the intervention trial met monthly for the first 18 months or so of the trial where they were told what to eat so it wasn't the balance trial because the intervention group got additional interventions and the subjects were initially followed for 8.1 years and they've now been followed for a further five years thereafter so the total follow-up is about 12 years now and the first disappointment for professor rosso and his team was that the reducing total fat intake may have small effects on risk of breast cancer no and no effect on risk of colorectal cancer heart disease or stroke and so that's how the that has been presented to the public that there was no harm caused by the diet but it didn't have very much effect so here's the the study on weight change for example they found that weight loss over eight years in the intervention group was 0.4 kilograms so instead of saying that the diet didn't cause massive weight loss they said a low-fat eating pan does not result in weight gain well actually this is meant to cause weight loss not to prevent weight gain more recently the data have been re-analyzed by this group and what did they find they found that people who reported that they ate a higher fat reduced carbohydrate diet from within this group was associated with a sharply lower risk of weight gain in adjusted models and this is marvelous our findings therefore challenge prevailing dietary recommendations suggesting instead that a low-fat diet may promote rather than prevent weight gain off to menopause so there and people don't recognize this this is a study of low-fat diet over eight years caused weight gain or should i say people eating a low carbohydrate diet for eight years did not increase their weight in fact they lost more weight with regard to colorectal cancer there was no reduction in the risk of colorectal cancer with regard to invasive breast cancer the same there was no benefit however the non-significant trends observed suggesting reduced risk associated with a low-fat dietary pattern indicate that longer plan non-intervention follow may yield a more definitive comparison so there was some evidence perhaps but it wasn't significant it wasn't enough to to tell people that a low fat diet prevents breast cancer what's really interesting is that in the last year or two they've started reporting this is a study from 2020 they've started reporting on insulin resistance as a risk factor for cancer and they show that higher levels of insulin resistance are associated with higher breast cancer incidents higher or cause mortality in people being treated for breast cancer and the same with all cause or cause mortality high insulin resistance as measured with homo ir identifies postmenopausal women at higher risk for cancer specific and all cause mortality who could potentially benefit from early interventions which is really interesting and what would an early intervention be it would be a low carbohydrate diet so once the group starts to look at the insulin resistance they notice something now it's really interesting that after my debate with professor assay he said noex is wrong because noke says that 50 to 60 percent of north americans are insulin resistant he said that's completely wrong it's more like six percent and it was quite clear he had no clue what instant resistance was so if one of the chief investigators in the women's health initiative didn't understand insulin resistance then what chance was there to identify insulin resistance as a risk factor for for heart disease in that population they do find it for cancers but did they look for other causes other diseases they also recently reported that higher intake of sugar sweetened beverages associated with a higher risk of early onset colorectal cancer amongst women and so they suggest we shouldn't be drinking sugar sweetened beverages but again so again where's the where's the pro where's the emphasis going emphasis is going on to carbohydrates and particularly refined carbohydrates sugar and fructose so let's move on now then to the the really important publication which was in 2006 and they concluded this this study did not significantly reduce the risk of heart disease stroke cardiovascular disease in postmenopausal women and achieved only modest effects on cardiovascular disease risk factors suggesting that more focused diet and lifestyle interventions may be needed to improve risk factors and reduce cardiovascular risk and that's what we call a post-hoc rationalization in other words we did a study we designed it it cost us 700 million dollars it didn't give us the result we want so what do we do we say we didn't go far enough well must you spend another 700 million dollars trying to make the study go far enough what if the intervention is simply ineffective and that's the the hypothesis one has to look at so what did professor rosso say he said the study shows that just reducing total fat intake does not go far enough to have an impact on heart disease risk while the participants overall change in ldl bad cholesterol was small and we don't use the term bad cholesterol anymore we saw trends towards greater reductions in cholesterol and heart disease risk in women eating less saturated fat and trans fats but that's that's irrelevant greater reductions in that particular group now he's talking about subgroups and we'll go into the subgroup analysis but the reality is the study did not find anything and if you go and look at the subgroups then you you're digging to try to justify why the study didn't prove what you said so then the director of the national heart lung blood institute professor nable said the results of the study do not change established recommendations on disease prevention so then why did you bother to do the study if you're not going to listen to the results instead women should continue to work with their doctors to reduce their risk for heart disease including following a diet low in saturated fat trans fat and cholesterol but the study showed that that made no difference and not sure cause harm but how why bother to fund this research if you don't follow the outcomes so actually no professors research nobel if you understand the null hypothesis you will acknowledge that your team spent 700 million dollars disproving the dietary hypothesis but they can't disprove it because that would threaten their whole careers trying to justify that your study would have found in favor of the low-fat diet if only you'd spent another 700 million dollars forcing your study subjects to eat a zero-fat diet is post-hoc reasoning proper scientists understand that the best approach to a study that disproves your own long-held beliefs is to acknowledge that you are wrong and that's apparently not possible so what was really interesting was professor russo came to cape town to debate me and a week before dr andreas ian felt the diet doctor you know who's influenced many of our lives was in cape town he came for a reason and we had lots of chats and i told him i would be interviewing or debating professor rosso and he said well tim let me show you his study so he then took that 2006 paper and showed me what it was like and as a consequence in the debate i presented that evidence and i thought i'll win this debate hands down because i've shown that the women's health initiative caused harm that the low-fat diet caused harm and so eventually i described it in this article in this african medical journal it's been quite widely read and this then and there i pointed out what the errors were in that study and this was thanks to andreas who showed me the problem so if we look at what's circled in red it says the following the hazard ratio for the 3.4 percent of women with cardiovascular disease at baseline was 1.26 so what that means is that women with coronary heart disease in 1993 when the trial starts they're randomized to the low-fat heart healthy intervention diet there is that we're at a 26 increased risk of developing further coronary heart disease complicated complications now if you look at the abstract you won't find that because they just they ignored that group and we would know at this this audience that this is entirely predictable as high carbohydrate diets produce hyperinsulinemia hypoglycemia and hypertriglyceridemia in those who metabolically vulnerable as they're insulin resistant but since the chief and the national institute of health don't believe that insulin resistance is either prevalent or of any consequence they'll ignore this key mechanism causing ill health and they just won't consider it in their explanations so that was the first problem they hid that you had to read through the paper and it was one tiny paragraph right in the middle of the paper but then they had a figure or this figure figure three which was really very interesting because let's look at it so if you look at each of these topics on the left so here we've got statin use and at the bottom we've got history of coronary heart disease so if we notice and we look at statin use you will see that there are two lines under the statin use either no or yes and if we move to the right there are two dots and they they both touch the vertical line if it falls to the left if the dot falls to the left it indicates the intervention is favored if it falls to the right it means that the comparison is favored so there was no benefit for taking statins whether you were on the diet or not on the diet but now remember that there are two lines there's a no and a yes under statin use and under all the rest there are two lines but when we come to the very bottom where it says history of coronary heart disease so in other words now we're comparing women who started the trial with heart disease versus those who didn't and then some of those women who started the trial with heart disease would have been on the comparison group diet and some would be on the intervention diet and the same for the group who had no heart disease so we're looking for two dots and two lines of data and what do we find we find one line of data but two dots so something's happened and what's happened is that the line for yes the data for the yes line is missing on this graph and as a consequence the two dots have moved up one line so if we were to correct the slide we put in yes and then we would take the two dots which i've now circled in red and we'd drop them one line and then we can interpret it and what this shows is that if you have no heart disease when you start the trial there was a slight favoring for the intervention group so that the group on the low-fat diet did marginally better and we'll go through that at length but much more important because this was significant the group who started the trial with heart disease that's the yes group when they went on the low-fat diet they did worse because that shows that they the comparison group was favored in other words the group that continued to eat the standard diet they were favored and that result was significant so the only significant finding in the study is presented on this table or this figure but you can't read it and when i pointed this out professor rosso said oh yes it was just a printing error but it made no effort to correct it and that you would think is the first responsibility of the scientist is to correct an error which is pointed out so we wrote of course this article in the soviet medical journal professor rasa's response was we missed the point and then he he presents some argument and he said i focuses on subgroup findings rather than the robust overall findings from the women's health initiative subgroup analyses are less reliable because blah blah blah that's not i asked the question why didn't you report the fact that the diet harmed some women and what were the robust overall findings i've given you them they were that if you went on the diet and you had previous heart disease you did worse that's the only robust finding and but as i will show by 2017 the group that now running the women's health initiative have suddenly become really interested in subgroup analysis so we'll look at them we'll look at the subgroup analysis so what wasn't acceptable in 2013 when i wrote that critique all of a sudden my 2017 subgroup analysis is important so here was the point that i made that i wish to understand why these authors have yet to communicate the single important finding of the women's health initiative study which is that women with established heart disease at the start of the trial fared worse if they changed the low-fat prudent diet then did those equally ill women who continued to eat a supposedly unhealthy diet and then i showed that the key finding in figure 3 is unintelligible because an essential line of text is missing and furthermore has no reference no reference is made to figure 3 in their response to me so figure 3 remains unaltered and they've still not answered the questions so that was my response and you'll notice that they the way they dismissed me was i blatantly missed the point the answer is they were not prepared to answer the question so there are a couple of other important findings from the study which are are very relevant here's a study of what happened if you went on the diet and you had type 2 diabetes well didn't look good women with diabetes at baseline did experience adverse glycemic effects of the low-fat diet which indicated that caution should be exercised in recommending a reduction in overall dietary fat in women with diabetes unless accompanied by additional recommendations to guide carbohydrate intake and that must be music to all of your ears this is 2011. additional recommendations to guide carbohydrate intake but that's not right you know that's nonsense women with diabetes at baseline need to be warned that if they replace dietary fat with carbohydrates their diabetes will worsen and why can't you say that because that's what the data show so why can't we tell them the truth without circumlocution you know we're using this word for guiding them but you should guide them to a low carbohydrate diet so the answer is how could their conventional advice possibly be wrong another interesting study finding from this group was that statin use was associated with increased risk of diabetes meditis and the hazard ratio is 1.71 which is quite the high increased risk and even when they just adjusted for potential confounders there was still evidence that people who were using statins were at increased risk of diabetes mellitus so that takes us up now to the more recent study in 2017 and what happens in 2017 is that they do now introduce subgroup analysis and in my view they do it because they're desperate to find some group benefits from this dutch intervention but what they show is that some groups it was very harmful for some groups so let's look at the data again these are the figures and i'll try to take you through how you read these figures so what we have here is all women on there under that arrow then we have normal tense of women so this is the first subgroup that these people remain normal tensive and they were normative at the start of the trial then the next group was hypertensive women and then the final group is the woman with prior cardiovascular disease so there we can see the total group on the left and then three subgroups this is the subgroup analysis we next look at these vertical lines and what you see you cast your eye down and you see where the circle if it doesn't move to either the left or the right of the line that means there's no benefit so you can see that there's no benefit and no harm for the total group when we analyze them as a as a total group and so there's no benefit or disbenefit from from the intervention or the comparison diet when we look at the normotensive women we can see that there are two lines which are slightly moved and the one is composite cardio coronary heart disease risk it's moved to the left which means it favors the intervention so there is some evidence that cardio coronary heart disease is less in the group who are healthy at the start and eat the low fat diet but it comes at some risk because the risk of stroke and that you can see that the second arrow the the bubble is to the right of the line indicating that it favors the group that didn't change if we then move on to the women without pro without prior cardiovascular disease but who had hypertension you can see there's no benefits and then when we look to the women with prior cardiovascular disease that's the vertical line on the right we see there are differences and firstly you'll see the bubble has moved way to the right and that means that that favors the comparison in other words the group that didn't change that continued to eat their conventional diet did much better that lower risk of heart disease and they had a lower risk of composite coronary heart disease and they had a lower risk of all-cause death so that's the benefit of not changing your diet if you had coronary heart disease all those benefits were significant and then when we look in the seconds the part of the study which was after the intervention so that data were up to the end of the intervention now there's the follow-up study for another five or so years and here we can see that the only benefit that i could identify was again coronary heart disease and the group with heart disease who continued to eat the higher fat diet so that's that arrow and they had some benefits also non-fatal heart attacks and so the only benefits that were represented in the into post-intervention trial accrued to women with heart disease who didn't change their diet no one else benefited so keeping on eating your normal diet when you had a heart attack was beneficial whereas changing your diet was not beneficial and then when they put both of this together now to try to make get some results that might be important and show that at least someone had benefited from this diet they again showed that in the women normal tense of women without prior heart disease there was a slight reduction in heart attack risk and that's shown by that arrow and also all-cause death was slightly reduced but notice that the extent of the bubble is touching the line so the the benefit is small but there was definitely evidence for harm and that's shown again on the columns on the right you will see that coronary heart disease rates were increased rates of non-fatal myocardial infarction were increased the coronary artery bypass grafting were also increased in the women so all these negative effects were in the women who continued to eat their normal diet compared to the women who changed their diet so once more the clear evidence that if you had heart disease and you change your diet you did much worse than if you continued to eat your normal diet and so composite coronary heart disease rates were also lower in the women who did not change their diet and similarly total cardiovascular disease and all-cause deaths were lower in the women who did not change their diet the women again who had prior heart disease who did not change their diets and all cause deaths were also lower as you can see with the final arrow so the question is how did the authors interpret all this information because the way it's presented and when you look at it carefully it's very clear that there may have been some benefit for people who were healthy the women who were healthy at the start of the trial and to change their diet and ate a low fat diet for the group that were hypertensive there was no benefit but the group who had established heart disease if they changed to a low-fat diet they clearly did much worse the evidence is overwhelming and it's consistent throughout the study so what they said conclusions cardiovascular disease risk in postmenopausal women appears to be sensitive to a change to a low-fat dietary pattern and among healthy women included both coronary heart disease benefit and stroke risk that's that's not what they found that is absolutely not what they found because that is that's a meaningless statement in the conclusions you meant to say what you found but this conclusion ignores the finding that the diet caused harm to postmenopausal women who began the trial in 1993 with established coronary heart disease so to explain this problem so they don't have to explain it the authors invoke two post-doc rationalizations of why the study did not find what they expected and the post-hoc rationalization number one was that we concluded that the trial results for coronary heart disease were uninterpretable in those women with prior heart disease and what finding is uninterpretable the finding showing increased coronary heart disease risk in women with established coronary heart disease randomized to the heart healthy diet we were not able to rule out the possibility that dietary changes in the intervention group participants that's my emphasis could have contributed to the unfavorable coronary heart disease experiences and then they had this sort of vague throwaway statement others have hypothesized an unfavorable chd effect based on studies in other contexts and then they give references and of course they hope you won't go and look at the references because if you do look at the references you might draw your own conclusions and the key reference is to the estrogen replacement and atherosclerosis study so what they're hoping is that you actually don't know what the outcome is because what they're saying is this they're saying the problem was that the women who were meant to change their diet to the low-fat diet didn't do that and then they got more heart disease as is predicted by this particular study so remember that they're using the estrogen replacement and atherosclerosis study to argue that if you were eating a high-fat diet and you converted to a low-fat diet your arterial disease would get better whereas if you were didn't change your disease would continue in other words if you continued to eat a high saturated fat diet your disease would get worse according to this particular study so let's look at that study so here is a study by darius and authors and the key graph is this one and what it shows is the changes in coronary artery diameter in people over a three year period at the end of which they were asked what diet have they been following and how much saturated fat how much monounsaturated fat how much polyunsaturated fat how much total fat how much protein how much carbohydrate that eaten during the trial so let's look at saturated fat on the left the quartiles of nutrient intake the one means that that's the group with the least intake and the right is the one with the most intake like for quartile for if their theory is correct then saturated fat intake should as you eat more your minimal coronary artery diameter should get smaller because showing there's coronary artery disease it does exactly the opposite so here we compare in group four those the people taking the most saturated fat group one is the group taking the least saturated fat and who has the most advance in disease the group taking the least saturated fat opposite exactly the opposite of the hypothesis similarly if you increase your polyunsaturated fat intake the disease became worse and or if you increase your carbohydrate intake it went worse now what was the diet change in this study it was to increase your carbohydrate intake and reduce your saturated fat intake so this study predicts that the women's health initiative intervention would advance coronary heart disease which is exactly what happened now the authors come along and try to argue the opposite they argue that the falsehood in the study was that some women who were meant to change their diet didn't change the diet and those are the ones who got the heart disease and that distorted the study but if they hadn't changed their diet and they had prior heart disease it should have stayed the same or got better not got worse they also showed that monounsaturated fat intake made little difference and total fat intake made little difference so these data are the precise opposite of what the authors are trying to make you believe either they don't know the data or they're actively attempting to hoodwink the readers and hence the scientific community and one other point i realized as i read this was if they believed that women didn't change their diet enough in the study and that there was in other words dilution in the intervention group because the intervention group weren't changing their diet enough or didn't change their diet or went back to eating saturated fat that would have been apparent in 2006 but they never reported that in 2006. so why do they first report it in 2017 so that's the first rationalization the second rationalization is the one that the women who went on the low-fat diet would be more likely not to take statins and that's entirely logical because but they would have to understand that at the start of the trial if you put women on a low fat diet their cholesterol is going to come down so therefore you'd expect fewer of them to take statins and so what they're saying is that in the intervention group there was more change in statin use which which doesn't make sense you'd expect the group that didn't change the diet to continue to eat a high fat diet would have higher cholesterols and so they'd expect to have more use of statins so the argument doesn't make sense it would be much more likely the statin use would be increased in the intervention group and so that would blur the difference and that's it tells you why the study was actually very difficult to design but what do they find they're the results these are women with price coronary heart disease we look at the right hand columns and you'll see there's absolutely no difference in the intake of statins between the groups in either interventional comparison groups at no time in the trial is there a difference so that's completely made up argument so both post hoc rationalizations are fallacious and so what were the true findings that should have been reported compared to the experience of women with coronary heart disease in 1993 who ate a diet with more fat including saturated fat post-menopausal women eating the hot healthy low-fat dga diet were at a 47-61 61 increased risk of developing further coronary heart disease during the 13 years of follow that's what the women's health initiative study shows and that's what should have been reported post-menopausal women with hypertension but without coronary heart disease in 1993 received neither benefit nor harm from eating the heart healthy dga diet whereas postmenopausal women with neither hypertension nor coronary heart disease in 1993 received some benefit from eating the heart healthy diet but at a cost of an increased risk of stroke so there was some benefit but it was marginal the percentage use of statin was equivalent in postmenopausal women with coronary heart disease whether they were randomized to either diet and the finding that risk of future chd events was greater in the group receiving the dga diet suggests that statin use didn't lessen the increased risk for future coronary heart disease events associated with eating the heart healthy dga diet but do remember that women with taking statins were at increased risk of developing diabetes and the most important practical finding of the study was that only those postmenopausal women who are the healthiest because they have neither coronary heart disease nor hypertension can be reassured that eating the heart healthy diet will not cause long-term cardiovascular harm and maybe of some benefit and i would argue that the post-menopausal women who are the healthiest are the ones who are not insulin resistant at the time the study trial so these were the absolutely healthiest people who were never going to get insulin resistance and diabetes and heart disease and they were when they were on the diet they did fine would they have done better on another diet maybe maybe not but it's the group who are insulin resistant with either hypertension or with coronary heart disease that do very badly on this diet and we all know why that is and it's expected absolutely to be expected so in 2019 this is the most recent publication from the women's health initiative and in this study they looked at only the normal intensive group and the hypertensive group and they removed the women who had coronary heart disease before the trial began so all the harm that we've identified how the patients who were harmed have been removed from this study and so the problem is that this is the study that will be remembered because no one's going to go back and look at the other studies they're going to remember this study this is the interpretation that's going to be mentioned so again they divide the group into normal tensive and hypertensive people and we look again at our vertical lines and you see that for the normal tense of women there was some benefit in reduced risk of coronary heart disease because that the line has moved to the left which favors the intervention so those women were who were normative no heart disease if they changed to the low-fat diet they improved their risk as far as coronary heart disease went if we look at the hypertensive group we noticed that they also benefited in terms of requiring less or the incidence of diabetes requiring insulin was reduced which is that doesn't make sense at all but that's what the finding said and then if we look at the cumulative follow-up in other words the intervention plus the follow-up thereafter we'll see that for neither group was there any benefit at all so for the total study when you start from 1993 right through till 2015 or so there was no benefit from changing the diet and but there was also no risk but remember we've excluded that group who did show harm they've been excluded and then the analysis was extended to look at the thinner people the body mass index less than 30 kilograms per meter squared that's the groups on the left and on the right is the with the higher body mass index and what we see that the there was one group who were who were heavier because they were obese they got some benefit in reducing breast cancer followed by death was reduced in the group who continued to eat the low-fat diet so they managed to dig up some finding but that again doesn't make sense because remember we've shown the study that if you had insulin resistance your breast cancer you're more likely to get breast cancer and you treat insulin resistance with a low carbohydrate diet not a low-fat diet and also some again benefit from in patients requiring insulin developing diabetes seems that they got some benefit as well if they were heavier group and again the heavier group there was some benefit for breast cancer reduction risk again so you can see that there are three arrows showing benefit of the low-fat diet but they don't really make sense and anywhere the margins are big and it would be difficult to say that these are definitive findings so let's move on to to my conclusions so the subgroup analyses find some small benefits of the low-fat heart-healthy diet in some groups of post-menopausal women and the reality is if you keep on digging you will find those benefits but remember this was a 700 million dollar study and they had to eventually dissolve devolve down to these subgroup analyses which shouldn't be necessary if there's a real finding it should come out in the the major data yet the main finding of the 700 million dollar study was that the diet harmed the health of women who began the trial in 1993 with coronary heart disease all the rest is academic window dressing perhaps at diverting attention from that extremely inconvenient finding and that's how i read those papers they're continually trying to justify why they didn't find what they should have found in january this year a study came out which really puts the whole thing in perspective and that's called the women's health study and this was a study involving 39 000 apparently healthy us women who were aged at least 45 years in 1992 and they randomized either to receive vitamin e or placebo or aspirin or placebo and they were followed for an average of 10 years and the primary outcomes of the study were the first major cardiovascular events and total invasive cancer and what they found was that vitamin e and placebo made no difference really there was no been no real evidence of benefit but fortunately they dissolved the study into a prospective study so they followed these women and then they said right what of all these things that we measured could predict what the outcome would be and the beauty was that they studied more they studied more than 50 risk factors particularly for future coronary heart disease so it's a fabulous study which came out of what was ultimately a negative originally negative finding so the group was followed prospectively for a further 11.3 years to measure biological predictors of future risk for the development of coronary heart disease and this is the paper that came out in january this year the association of lipid inflammatory and metabolic biomarkers with age of onset for insulin coronary heart disease in women so what they're reporting is what were the risk factors that predicted the development of coronary heart disease and this is the slide that is mind blowing because this finally puts it all in perspective and what you see is that these are the hazard ratios or the relative risk ratios and you can see right out in front type 2 diabetes by a mile hazard ratio of 10 comma 7 which is enormous what's the second one metabolic syndrome what's the third hypertension what's the fourth obesity and what are those all markers of insulin resistance insulin resistance insulin resistance and when they looked at the blood biomarkers there's a variable called the lipoprotein insulin resistance and that was the single factor in the blood that predicted risk where did ldl cholesterol come in well it it's still running it hasn't finished the race because it's so loud so slow and so far behind and you can see the hazard ratio is one comma three eight which is meaningless so what's really interesting is that the rasso hypothesis has been disproved by this study his hypothesis remember the debate we had was that ldl cholesterol predicts heart disease risk it doesn't what is my hypothesis what is it diabetes does and unfortunately for the women's health initiative that was what the finding was so the women's health study establishes the type 2 diabetes mellitus is the single most important risk factor for the development of future coronary heart disease there it is it closes the case we can we don't need to discuss this any further and the most important biochemical markers are those of insulin resistance most especially the lipoprotein insulin resistance score ldl cholesterol is of little predictive value so what does that mean for the women's health initiative study well the women's health initiative was a 700 million dollar investment the goal of which was to prove the diet heart and lipid hypotheses instead it proved that the low-fat heart-healthy diet harms the health of those with pre-existing heart disease whereas the woman's health study shows that the best predictor of future coronary heart disease is type 2 diabetes not the blood cholesterol concentration so the most credible interpretation of the woman's health initiative is that the low-fat hot healthy diet promotes coronary heart disease in those with pre-existing coronary heart disease because they have insulin resistance or type 2 diabetes and therefore my conclusion is that according to the principle that first do no harm it's no longer ethical to prescribe the low-fat heart-healthy diet to those with insulin resistance or type 2 diabetes that's what the study shows and we know that there's so much other evidence collaborating this finding but we now know that the most expensive diet study proved it's unethical to promote a low-fat diet for people with corny heart disease so let's return to my debate with professor rosso and remember what he said unfortunately no definitive clinical trial has tested the dietary hypothesis he said this or this was written in 2015. so what about the findings of your study the woman's health initiative do we just ignore them and then he also said we would do well to heed the advice of hippocrates remember i will apply dietetic measures for the benefit of the sick according to my ability and judgment i will keep them from harm and injustice sometimes interpreted as premium non-negori first do no harm so what is the woman's health initiative tell us about first do no harm and the answer is it tells us that you cannot prescribe a low fat diet for women with coronary heart disease and eyes because that will cause harm so it's unethical to do it and i would argue that this is probably similar for men as well that diabetes is the predictor of coronary heart disease that's now established and the reversal of type 2 diabetes is possible with a low carbohydrate diet so therefore we don't need any more diet heart studies to prove what we now know that we want to prevent type 2 diabetes and there's only one thing that really does that and that's a low carbohydrate diet so thank you very much for your patience and interest and i look forward to interacting with you again sometime in the future yeah remarkable uh remarkable lectures it's got that knack of uh of diving into the science and uh and picking out the uh well yeah what's right and what's wrong basically and the scary thing to me paul is that you know we're seeing this time and time again now that people are manipulating results i always assumed you know i was very naive i guess i assumed that you know whatever you read in you know some prestigious journals uh you assume was correct because you know you assumed they went through a fairly rigorous uh review process and that wouldn't be published unless it was it was true and yet time and time again now we see in these nutrition studies that the data is manipulated to suit the beliefs of the people uh doing the study and it's pretty scary really well and i think the most interesting thing is that this kind of misrepresentation of results can be done in such a way that even educated doctors and scientists are not able to detect it and the reason is be i suppose they could detect it if they were thinking about it and if they are suspicious enough but there's an element of trust in something that's published in a peer-reviewed journal that you expect you know what you see is what you get and the simple fact is a lot of the way the data is presented is the conclusions that are drawn do not reflect the actual data yeah i've become a real sort of skeptic i must admit everything i read now i tend to be skeptical about which is uh which is sad in a way but uh at least it means i'm examining it but but for most people and myself included i don't have the scientific rigor and the experience to really you know pick the pick out what's uh what's right and wrong so we really rely on people like yourself and tim noakes and zoe harcom who will be hearing from later in the weekend to anal who are very good at analyzing these uh these studies and picking out what uh you know what what the false data is really or the false conclusions anyway well i think the i think the key points to take away from tim's presentation too is one that the original women's health initiative study actually found evidence of harms in a subset of postmenopausal females a follow-up study actually found that those harms had apparently increased with time consistent with dose dependency and in the most recent publication of the women's health initiative the authors totally neglected to publish data on that subset of woman altogether which all seems to be a little bit suspicious yeah really scary uh cleary stuff and uh you'd love to try you know hear them try and justify what uh what they're doing but obviously they're not gonna they just uh you know bluster as tim discovered with his uh you know debate i mean they'll they'll just try and uh change the topic and not address the not address the issues they're very good at uh very good at that so it's really disappointing and very disillusioning as a scientist uh you know that there are people out there trying to do that but you know as as we all know there are very powerful forces that don't want anything to change and uh both from uh from our financial point of view but also a reputational point of view it's very difficult to do what tim did and that is to basically admit that he'd been wrong for 30 or 40 years been giving the wrong advice i mean that's that's pretty uh that requires a fair amount of courage and and someone like tim has that sort of courage but uh you know many others aren't prepared to do that because uh the reputational damage that they would uh that would occur i mean to me actually admitting you're wrong it is a good thing you know i mean to come out and say you know i've looked at the data i've read and rethought the way i uh you know i have new information i i admit that i was wrong and and to me i think that you know that makes you look good in the eyes of science i think but obviously to a lot of people it's very threatening it's completely illogical that somebody like tim would be criticized for changing his mind when his understanding of the science is what has driven that i mean to criticize people for actually evolving their views is basically to basically prevent any further advancement of medical science it's completely and utterly illogical yes but it happens all the time i mean i guess people feel threatened uh and they react to that threat by by being uh aggressive defensive and and they'll try and take on the people who are threatening their livelihood reputation uh whatever and and the science gets lost in all this it's all about personalities and reputations and money and uh grants and and so on so yeah look science has got uh got a lot to uh to sort itself out i think and and i i really believe that uh the journal the review system in journal needs need some sort of revision i mean uh people are not being rigorous enough in their reviews i mean this so these problems should have been picked up in the review of the journal by the reviewers or by the editors at least but i think you know basically uh if you've got prestigious authors people just let things go and publish it whatever they say oh these people have got a good track record they must be okay we'll publish it anyway without even examining the science of these papers it's that concept of eminence-based medicine winning out over actual evidence-based medicine [Music]

Channel: Low Carb Down Under

Views: 43,278

Rating: 4.948102 out of 5

Keywords: Low Carb Down Under, LCDU, www.lowcarbdownunder.com.au, Low Carb International All Stars 2021, Tim Noakes, Real Meal Revolution, Lore Of Running, Women's Health Initiative, Nutrition Network, Diet Heart Hypothesis, Insulin Resistance, Cardiovascular Disease, Diabetes

Id: n-wjEnsEXI0

Length: 60min 43sec (3643 seconds)

Published: Sat Nov 13 2021