by Tim Noakes
And when will SAHA acknowledge that abnormal lipid profiles – the atherogenic dyslipidaemia that causes coronary heart disease – are driven by carbohydrates, not fats, in those who are insulin resistant (Chapter 17)? So that a diet high in fat improves the lipid profiles of those with metabolic syndrome70 besides providing additional beneficial effects, including significantly reduced blood pressures,71 lessened hyperinsulinaemia and reduced hyperglycaemia.
The problem for both the HSFSA and SAHA is that, in the not too distant future, both will be forced to face their moments of truth when the educated public finally grasps that it has been misled by these surrogates for Big Pharma and Big Food and that, in its naiveté, it trusted too certainly.
It will not be a benign moment for either organisation.
This book will only accelerate the arrival of that moment.
If the goal of the HSFSA and SAHA truly is ‘to help South Africans beat obesity, heart disease and also diabetes’, they could quite easily achieve this by listening to the evidence. Their inability to engage with the evidence proves that they have a different agenda.
The diet that the HSFSA, SAHA and ADSA have promoted for the past few decades has failed absolutely to stem the tsunami of obesity and T2DM that we now face. In fact, as I argue in Chapter 17, it has caused the very medical disaster that it claims to prevent. The basic text of Narcotics Anonymous, an organisation specialising in the treatment of drug addiction, includes the following: ‘Insanity is repeating the same mistakes and expecting different results.’ The HSFSA and ADSA need to address their shared addiction to providing marketing misinformation on behalf of their funders (Table 7.1). This misinformation is not evidence-based; it is known to be wrong; and it has caused, and continues to cause, great harm to the health of many South Africans, most especially those with IR.
Perhaps the single most important factor in the development of my academic career was the founding, with Morné du Plessis, of the Sports Science Institute of South Africa and its subsequent growth. This was made possible thanks to generous funding from Discovery Health, which allowed us to increase our research productivity exponentially. But perhaps predictably, when I discovered the LCHF diet in December 2010, my relationship with Discovery Health became strained.
The reason for this tension was Discovery Health’s reliance on the ‘evidence’ for the health benefits of the LFHC diet, despite the fact that no such evidence exists. In addition, Discovery Health continues to focus on the role of cholesterol in the prediction of heart-attack risk, completely ignoring the key role of IR and NAFLD. I remain perplexed as to how a company that prides itself on innovation – on being at the cutting edge of human health promotion – can still be getting it so completely and utterly wrong.
With time, Discovery Health withdrew its funding from both me and the institute. And so I was surprised when I received an invitation from the head of Discovery Vitality to defend the Banting diet at the Discovery Vitality Summit in Johannesburg on 1 August 2014. The original list of speakers that I was told would be engaged in the debate when I accepted the invitation was rather different from the group I faced on the day. In particular, UCT professor of nutrition and dietetics Marjanne Senekal had been replaced by two key players in the publication of the Naudé review: Professor Celeste Naudé and her co-author, Professor Jimmy Volmink, dean of Stellenbosch University’s Faculty of Medicine and Health Sciences.
First up was Mungal-Singh representing the HSFSA. She offered similar opinions to those expressed in her open letter the previous year, but in the end she seemed almost to embrace my proposal that we should all avoid eating processed foods. Remarkably, her talk focused on what the HSFSA found acceptable about the LCHF/Banting diet. ‘We agree on the need to avoid sugar, processed foods and refined carbohydrates,’ she stated. ‘We need to have more whole foods.’ As a result, we should all focus on the ‘common enemy’ of ultra-processed foods laden with sugar, salt and refined carbohydrates, because ‘that’s what’s killing us’. (This was pretty much what we wrote in The Real Meal Revolution.)
Next up was Naudé. As she spoke, the thought occurred to me that her rejection of the LCHF diet is perhaps because it advocates the consumption of meat. She appears to favour vegetarianism, as, I have learnt, do many of the more publicly vocal South African dietitians. My conclusion was based on her reasoning of why humans should avoid eating red meat. Her ‘evidence-base’ was a raft of observational (associational) studies that can never prove causation – as she should know, being a specialist in this field.
Volmink’s lecture was on the nature of scientific evidence, and the relative value of anecdotes, longitudinal observational (associational) studies and RCTs, somewhat along the lines of what he had said at the conclusion of the Centenary Debate (Chapter 4). Surprisingly, as director of the Centre for Evidence-based Health Care at the University of Stellenbosch, he failed to make the obvious point that almost all the evidence on which the current dietary guidelines are based comes from longitudinal observational studies that have little or no scientific validity. Association, he should by now know, does not prove causation.
Here is what Gary Taubes has to say in Good Calories, Bad Calories:
The only way to establish cause and effect with any reliability is to do ‘controlled’ experiments, or controlled trials, as they’re called in medicine. Such trials [RCTs] attempt to avoid all the chaotic complexities of comparing populations, towns, and ethnic groups. Instead, they try to create two identical situations – two groups of subjects, in this case – and then change only one variable to see what happens. They ‘control’ for all the other possible variables that might affect the outcome being studied. Ideally, such trials will randomly assign subjects into an experimental group, which receives the treatment being tested – a drug for instance, or a special diet – and a group, which receives a placebo or eats their usual meals or some standard fare.72
In their lectures, Volmink and Naudé should have emphasised that longitudinal observational (associational) studies can only ever identify ‘possibilities’, i.e. possible causal relationships between different variables. These studies can never identify ‘probabilities’, i.e. real causal relationships between two variables (for example, between red meat intake and cancer, or between eating saturated fat and developing CHD).
Volmink should have explained that the evidence-base for the nutritional sciences is profoundly weak, almost non-existent, because almost all this evidence comes from longitudinal associational studies that cannot identify causation. He should have informed the audience of some of the conclusions that Dr John Ioannidis, professor of medicine at Stanford University and author of many of the definitive articles on the failings of evidence-based medicine,73 has come to:
In nutrition, there has been so much observational and mechanistic research that thousands of spuriously significant associations have already been produced and translated in heavily opinionated, debated recommendations. Getting another significant result in a field that is already saturated with so many significant results offers no information gain: we still (think we) know what (we thought) we knew. Conversely, ‘negative’ results offer high information gain, because they change our probably false beliefs about potentially effective interventions … we should hope to get more ‘negative’ results in the future.74
The legion of false positive findings explains why ‘[a]lmost every single nutrient imaginable has peer reviewed publications associating it with almost any outcome … Many findings are implausible. Relative risks that suggest we can halve the burden of cancer with just a couple of servings a day of a single nutrient still circulate widely in peer reviewed journals.’75 As a result, these findings predict that ‘if we increase or decrease (as appropriate) intake of any of several nutrients by 2 servings/day, cancer will almost disappear worldwide; manipulating the uptake of a single nutrient suffices’.76 To rid nutrition science of this impossible conclusion, Ioannidis and his colleagues provide guidelines ‘
for improving the conduct, reporting and communication of nutrition-related research to ground discussion in evidence rather than solely on beliefs’.77
Why did neither Volmink nor Naudé highlight this fundamental problem in nutrition science, specifically that it is a discipline based on belief, not critically derived evidence? Perhaps because then they would have had to question the real value of much of the work produced in their research unit, including the Naudé review. As I discuss further in Chapter 17, it is Ioannidis’s opinion that only about 3 per cent of meta-analyses are ‘decent and clinically useful’. ‘The production of systematic reviews and meta-analyses has reached epidemic proportions,’ he writes. ‘Possibly, the large majority of produced systematic reviews and meta-analyses are unnecessary, misleading, and/or conflicted.’ The main driver of this epidemic is the irresistible attraction of ‘easily produced publishable units or marketing tools’.78 Or, in the case of the Naudé review, the persecution of an unwelcome opinion.
As James le Fanu writes in his book The Rise and Fall of Modern Medicine: ‘epidemiological studies are easy to perform … and thus rapidly filled the vacuum of ignorance … This self-imposed insistence on rigorous methodology is missing from contemporary epidemiology; indeed the most striking feature is the insouciance with which epidemiologists announce their findings, as if they do not expect anyone to take them seriously. It would, after all, be a very serious matter if drinking alcohol really did cause breast cancer.’79 In an earlier version of his book, Le Fanu even suggested: ‘Meanwhile the simple expedient of closing down most university departments of epidemiology could both extinguish this endlessly fertile source of anxiety-mongering while simultaneously releasing funds for serious research.’
The final anti-Noakes speaker at the debate was Dr Anthony Dalby, a Johannesburg-based cardiologist in private practice, whom I have known since 1976, when we were both researchers in Professor Lionel Opie’s unit at UCT. While the other speakers may have been somewhat measured in their criticisms of me and the Banting diet, Dalby came over as the original Big Pharma attack dog.
The first important point to make about his lecture is what was missing. Dalby failed to declare his conflicts of interest. He did not acknowledge that since 1994 he has served as national lead investigator for South Africa on the international steering committees of 39 phase III drug trials in a variety of cardiac conditions. He should have at least declared whether or not he has ever received remuneration for undertaking these studies and, if so, the magnitude of that remuneration. He also failed to declare that he serves on the advisory boards of leading health and pharmaceutical companies, including Aspen, AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, Novartis, Pfizer, Sanofi, Servier and Discovery Health. In addition, he represented the South African Heart Association in its discussion with Discovery Health in developing guidelines for the prescription of lipid-lowering drugs by South African doctors.
Dalby did not mention that it was he who first suggested that the pharmaceutical industry should be involved in the formulation of the South African guidelines for the management of high blood cholesterol concentrations.80 How could anyone think that, in contributing to the guidelines, the industry would have any interest other than its own commercial welfare by ensuring that it ‘captures’ academics, those practising physicians who are key opinion leaders and regulatory bodies?
Dalby also did not acknowledge that there is little evidence for much of what cardiologists do in their daily practice. Acknowledging the remarkable ineffectiveness of statin drugs would have been a good start. Dalby publishes papers in local medical journals extolling their virtues, especially when combined with regular exercise and dietary change: ‘Lifestyle changes combined with statin therapy provide potent protection against coronary heart disease,’ he and Opie wrote in one such paper.81 This statement has no factual basis, because, to my knowledge, no study has yet reported on the effects of lifestyle changes combined with statin therapy. Similarly, I wonder if Dalby ever warns the general public that neither coronary bypass surgery nor the stenting of coronary arteries prolongs life (see Chapter 3).
Dalby later fulminated about my ‘criminal’ behaviour, yet he did not mention that in 2009/10, five of the pharmaceutical companies for whom he works in an advisory capacity – Pfizer, Novartis, Sanofi, AstraZeneca and Eli Lilly – were fined a total of $4.7 billion for various fraudulent (i.e. criminal) activities.82
I also wonder if Dalby ever informs patients who participate in the pharmaceutical trials he oversees that their data belongs solely to the company funding the trial, and that the company has the right to do pretty much whatever it likes with that information. Danish physician and author Dr Peter Gøtzsche believes that these trials are so lacking in transparency that an honest patient consent form should read:
I agree to participate in this trial, which I understand has no scientific value but will be helpful for the company in marketing their drug. I also understand that if the results do not please the company, they may be manipulated and distorted until they do, and that if this also fails, the results may be buried for no one to see outside the company. Finally I understand and accept that should there be too many serious harms of the drugs, these will either not be published, or they will be called something else in order not to raise concerns in patients or lower sales of the company’s drugs.83
Interestingly, the one personal fact that Dalby did declare in his lecture was that he is, in his own words, ‘obese’. Having admitted this, he should perhaps also have mentioned whether or not he has IR, NAFLD and metabolic syndrome, and, if so, precisely why he feels he developed these conditions and what, if anything, he is doing to correct them.
Dalby’s lecture was the standard defence of the absolute infallibility of the diet-heart and lipid hypotheses. According to his argument, the key drivers of heart disease are fat in the diet and cholesterol in the blood. As a result, any increase in blood cholesterol concentrations caused by a high-fat diet must cause arterial disease and early death from a fatal heart attack. One of his patients, he reported, had more than doubled her blood cholesterol concentration, from 5 to 13 mmol/L, when she went on the Banting diet. This single case, he argued, proves that my advice to increase dietary fat intake is ‘criminal’.84
As part of his tirade, Dalby read the disclaimer in The Real Meal Revolution:
The information and material provided in this publication is representative of the authors’ opinions and views. It is meant for educational and informational purposes only and is not meant to prevent, diagnose, treat or cure any disease. The content should not be construed as professional medical advice. As the authors are not offering prescriptive or professional medical advice they cannot be responsible or liable for the decisions and actions which readers undertake as a result of reading this content. Should the reader need professional assistance, a qualified physician or health care practitioner should be consulted.
To Dalby, this was evidence that my co-authors and I were the cynical purveyors of death and destruction. The fact that this disclaimer is the work of the publishers, to protect themselves, and is present in every similar book ever published, was lost on Dalby. The equivalent would be Dalby’s own use of medical professional liability insurance. I would never assume that he takes out medical malpractice insurance so that he can act ‘criminally’ as a cardiologist.
As the talks continued, I began to wonder what had brought together this quartet – comprising the head of a non-governmental organisation, two academics and a private cardiologist who was South Africa’s leading proponent of the use of statin drugs – to ‘debate’ the Banting/LCHF diet under the banner of Discovery Health. Four against one was hardly designed to be a balanced debate.
In my lecture, I argued that the single most important factor determining what we should be eating is our individual level of IR. This, I proposed, is the underlying condition causing obesity, T2DM, gout, hypertension and atherogenic dyslipidaemia in those eatin
g high-carbohydrate diets. (Only later would I appreciate that cancer and dementia fall in the same category.)
Next I spoke about the work of Dr Gerald Reaven, considered the father of IR,85 which shows that chronically elevated blood insulin concentrations explain how high-carbohydrate diets lead to this constellation of medical conditions in those with IR.86 Thus, I proposed, the key feature of a ‘balanced diet’ is that it should minimise insulin secretion at all times.
I wound down with a brief review of the absence of evidence that saturated fats cause heart disease, before concluding with a short overview of the work of Harvard’s Dr Alessio Fasano that shows how gluten and gliadin present in wheat, rye and barley causes the leaky gut syndrome that contributes to another array of medical conditions which remain poorly managed.87
At the conclusion of the debate, the head of Vitality Wellness, Dr Craig Nossel, was asked whether the Vitality HealthyFood benefit would be revised to fit with my recommendations. He answered: ‘We have a responsibility to 3 million people in South Africa and millions globally so we can’t afford to take any chances with their health. We stress that a healthy, balanced diet is important and this is reflected in the HealthyFood benefit offered through Vitality.’88 Not documented was his throwaway line to the effect that I might be able to tear the pages about high-carbohydrate diets from Lore of Running when my opinion changed, but Discovery Health had to act more ‘responsibly’.
There is a final interesting point to make about the debate and my relationship with Discovery.
Two years earlier, I had been invited by Discovery Health to speak at the annual Discovery Leadership Summit. I was a last-minute replacement for Archbishop Emeritus Desmond Tutu, who had withdrawn because British prime minister Tony Blair was on the speaker list. I spoke on the power of the mind in sport and had the great privilege of introducing and then interviewing the South African golden boy of swimming, Chad le Clos. Le Clos had recently returned from the 2012 London Olympics, where he had beaten the greatest Olympian, Michael Phelps, by 0.05 seconds to win gold in the 200-metre butterfly.