Archive | March 2016

From shady Statin research to poor dietary guidelines.

In my last blog post I talked about the good, the bad and the ugly in regards to the new Dutch dietary guidelines by the Dutch Nutrition Center (Voedingscentrum). In the ugly part, i talked briefly about how shady cholesterol lowering drug (statin) research seeped into nutritional science, leading to dietary guidelines that should at best be regarded as controversial. In this post I will look a bit deeper into how shady science , in a very unfortunate way ,found itself a foundational place in nutritional science, and how this science has managed to, even today poison dietary guidelines and in effect poison the health of whole populations.

I will look at this from the perspective of the Dutch dietary guidelines, but judging from many other national nutritional guidelines, a similar cascade has probably been applied in the creation of other such national guidelines. So let’s look at the dutch Disk of Five (Schijf Van Vijf) and trace how the advice came to be.

The new Dutch dietary guidelines refer to saturated fats quite often and once to LDL-cholesterol. These are foods the guidelines wants us to avoid, and the foods we should use instead:

  • Coffee high in cafestol; use filtered coffee instead.
  • Hard margarine; use soft margarine instead
  • Hard baking fats; use liquid margarine or olive oil instead.
  • Hard deep-frying fats; use vegetable oils instead
  • Butter; use soft margarine instead for bread or liquid margarine for baking.
  • Coconut oil; use vegetable oils or olive oil instead.
  • Non-lean meat cuts; use lean cuts instead.
  • Full-fat dairy; use low-fat dairy instead
  • Croissants; use full-grain bread-buns instead.
  • Cookies; use full-grain peanut-butter sandwich instead.
  • Chocolate; use fruit and nuts instead

Next to these, the guidelines advise the consumption of legumes for its LDL lowering properties.

There are issues with many of these guidelines, issues we will get to later in this article. First we will look at why the the Dutch Nutrition Center made these recommendations. What reasoning was behind them and where did the data for this reasoning originate? Well this is where things get a bit complex. The  Dutch Nutrition Center claims their recommendations are science based, and objectively speaking they are. So how did things go so wrong anyway? Let’s have a look.  The guidelines by the Dutch Nutrition Center are themselves based mostly on a more abstract guideline by the Dutch Board of Health (Gezondheidsraad). These guidelines come with multiple background documents, including one on macronutrients, that I tried to give feedback on when it was published due to in my view questionable use of LDL-c as causal marker and control for cardiovascular disease. My input was rejected as the Board of Health claimed the subject was covered in another document describing the use of a set of three markers:

  • Blood pressure
  • LDL-cholesterol
  • Body Mass Index

We will leave blood pressure for what it is, and for BMI I’ll refer to my earlier posts on that subject. The thing we are interested in here is LDL-cholesterol. The document justifies its use of LDL-cholesterol as stand-in for CVD endpoints by refering to a publication by the American Institute of Medicine (IOM) entitled Evaluation of biomarkers and surrogate endpoints in chronic disease.

 

BCMJ -#51Vol4-May09.qxp

And this is where the real problem starts. Surrogate endpoints. Remember that correlations aren’t necessarily the same as causation. Remember the difference between a good risk marker and a usable control? Well, this document, to some extent, for the Dutch Board of Health apparently to a decisive extend claims that LDL-c can be treated as being causal, that is, LDL-c can be used not only as a risk MARKER, but actually as a control. We won’t go into LDL-c as risk marker here. The case of LDL-c being a risk marker is solid. There are clear signs that there are multiple much better markers available today, in fact the same goes for the other two markers we just mentioned, but let’s accept LDL-c as a useful marker. The interesting part is: how does the document make the leap from marker to control, or as the document refers to it, surrogate endpoint?  

The answer is: intervention studies. Statin based intervention studies to be precise. So to summarize, the current dietary advice hinges on a collection of statin intervention trials. On first glance there wouldn’t seem to be anything wrong with that. We have intervention trials where lowering bad cholesterol (LDL-c) has shown statistically significant reduction of real CVD linked endpoints, so LDL-c is indeed a useful control, right? Well not quite. It could be if lowering cholesterol was all that statins do, and it would be if next to being statistically significant, the results also had practical significance. And guess what, on both accounts this turns out not to be the case. First, statins combine a whole set of potentially CVD preventative related properties:

  • Lowering LDL-C
  • Thinning the blood
  • Acting as antioxidant
  • Acting as anti-inflammatory agents.
  • Lowering triglyceride levels

And on the other side of the spectrum, statins have actually been linked to CVD causing effects. In fact, some recent trials actual show increased CVD in statin treated groups.

  • Worsening cholesterol sub-group/size profiles
  • Reduce protection from artery calcification by inhibiting K2 synthesis.
  • Reduce protection from peroxidative stress by impairing selenium containing proteins.
  • Impair muscle (including heart) functions through depletion of coenzyme Q10

So far we only looked at CVD related properties, but statins are not without side effects:

  • Vitamin D depletion
  • Severe cognitive issues including memory loss
  • Increased risk of diabetes
  • Severe muscle problems
  • Liver damage
  • Birth defects
  • Erectile problems

Some of these side effects come with their own increased mortality numbers. Others just diminish the quality of life without actually killing you. Recent research has shown that using statins for many many years will increase your life expectancy by just a few days. Not that impressive considering that the price for those days may be years of muscle, cognitive and erectile problems. And then there is the controversy surrounding statin trials. The most notable being the JUNIPER trail. But also recent meta analysis that show that statin results have been exaggerated and side effects have been downplayed in a scaringly structural way.  Multiple MDs as a result of the controversy have called for a complete reappraisal of  the cholesterol theory of heart disease. The bottom line: Statin trials, from a data engineering perspective could never prove LDL-c causality for CVD, and could never prove the suitability of dietary changes aimed at LDL-c reduction as an in any way useful control for CVD.

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So let’s look again at some of the guidelines that these statin trials ended up spawning. Remember that two known positive effects of statins were its function as antioxidant and anti inflammatory agent?  Well, let’s look at how the Dutch dietary guidelines are doing on those. Especially those guidelines based on the LDL-c hypothesis. The first thing that stands out is the use of cold fat sources high in polyunsaturated omega 6 fats as alternative to fat sources high in saturated fats. It is well established that an imbalance of omega 6 and omega 3 intake works pro-inflammatory. As such, saturated fats, while leading to higher LDL-c levels than omega-6 fatty acids, also lead to lower inflammation when compared to omega 6. Inflammation has not only been linked to CVD, but to a multitude of major diseases including diabetes and cancer. 

Than there is the advice for cooking fats. Unsaturated fats can be healthy in the right proportions. At a proper ratio of omega 6 to omega 3, unheated polyunsaturated fats can undisputedly be healthier than saturated fats and so can monounsaturated fats. But that is cold. Once you start cooking with it, the tables turn. While LDL-c as shown above is highly questionable when used as control, the link with ‘oxidized’ lipoproteins is significantly more convincing.  Oxidized unsaturated fatty acid consumption is linked quite strongly with oxidized lipoproteins. So where there is sense in replacing butter with MUFA-rich oils  for cold unheated usage, when it comes to cooking, the reverse must be considered. Saturated fats in butter and coconut oil are stable fats that don’t oxidise as quickly as unsaturated fats in olive oil and vegetable oil. Suggesting the use of MUFA and PUFU over SFA for cooking purposes should be considered the most questionable advice in the dietary guidelines.

mrfit-blood-cholesterol-and-heart-disease

Finally there is the epidemiological data. High cholesterol isn’t the only cholesterol related risk marker that we can identify in the data. Low cholesterol is also a serious risk marker. Thus a population wide guideline with the effect of the reduction of cholesterol levels may very well backfire. Looking at the China Study II data set, SFA intake overall is relatively low. When however we at mortality figures and look at the top ten correlation for foods that potentially improve the probability to live to the ripe old age of 80 years old, SFA (and MUFA) truly stand out. When we look at cholesterol levels, the lowest levels are linked quite strongly to the highest mortality. Unfortunately, due to distribution concerns we can’t check the link for statistical significance, but we can take it as a strong indication that cholesterol lowering might be detrimental to the health of certain groups of people within the population.

dominoes

Summarizing,  statin trials, due to the complex working of statins, the controversy surrounding some statin studies,  the at-best unimpressive effects of statin intervention, and the combination of different beneficial and decremental effects of its use, must be seen as being inconclusive with regards to LDL-c being causal for CVD. If we combine this fact with known health effects of some of the SFA replacements that are advocated in the guidelines, we can only conclude that shady statin trials poison not only nutritional science, but in effect literally poison the whole population of countries that indirectly base their dietary guidelines on the outcomes of these statin trials under the mistaken assumption that the results of these trails are in any way conclusive with respect to the causality of LDL-c for cardiovascular disease.

 

This entry was posted on 29th March 2016. 1 Comment

New Dutch dietary guidelines; The Good, The Bad & The Ugly

Schijf-van-Vijf-vaknamenWhenever anything related to nutrition hits the media in the Netherlands, the first thing that tends to happen is that the Dutch media consults with the expert of the semi authority Voedingscentrum are consulted. This organisation that in the past has repeatedly been criticized  for questionable ties with the food industry have acted as the conservative sentinels of both the food industry and of the low-fat school of nutrition for many years untill this very day. Fair to say that when the Voedingscentrum announced an update of their “schijf van vijf”, a Dutch variant of the Food Pyramid, expectations were not that high with those that viewed them with suspicion. And to be fair, as far as science based goes, the resulting guidelines are absolutely not without their faults. Yet given their reputation amongst critical thinking nutritionists and well informed consumers, they could have been much worse indeed. In this blog post I want to look closely at the Dutch guidelines. At how they both exceed expectations and fall short of delivering that what Voedingscentrum claims as its mission.

The Good

Lets start with the good part of the guidelines. And this is a big one that should silence many of the more paranoid critics of Voedingscentrum. The new guidelines take a firm stand against processed foods. At least most processed foods. We will look at the exceptions later, but its a clear sign that Voedingscentrum is not going out of it’s way to please the food industry parties that it has been linked too. A second really good one and a big step forward is their stand against fruit juice. Given that a glass of fruit juice has extreme levels of sugar that inarguably are very much unhealthy, a very good step forward indeed. The third and final truly good part is the addition of nuts and legumes. Both foods that have been shown to have amazing health benefits.

To summarize the good parts:

  • Whole foods.
  • A big NO for fruit juice
  • Nuts
  • Legumes

The Bad

So much for the good parts. Now lets look at the stuff that Voedingscentrum got wrong. Or at least the part of the guidelines that are not directly supported by both epi data and controlled trails. And some of the parts that are simply and terribly wrong. Lets start of with the questionable stuff. The guidelines are pretty much dominated by starchy foods. Grains, and potatoes basically. Both epi data and controlled trails are known to show convincingly that there are strong links between grain consumption, specifically wheat consumption, and many serious modern illnesses including diabetes, heart disease, obesity and basically the whole package that comes with insulin resistance. Yet almost 30% of the food diagram is dominated by grains. Their defence: it’s all full grain exclusively, we ban things like white rice, white bread and anything not made from whole grains. Well, that is a nice theory and there are some signs that full grain, when not highly processed, may indeed be less harmful than highly processed white flour, but we are basing one third of the guideline on this nice theory that so far has very limited controlled trail evidence and basically non-existent epi data. Not something you should want to bet the health of a nation on. If we look at epi data from sizeable data sets for noticeable health effects, we see that starchy tubers have decremental effects on live expectancy and that people using unprocessed grains, especially rice, do much better than people consuming high amounts of processed wheat flour products. That is, there is compelling evidence suggesting switching wheat flour products and starchy tubers for rice is a good idea. There is a minimum amount of evidence showing that eating processed wheat at all is anything more than slightly less harmful when you choose the full grain variant.

Remember the good part of taking a stand against fruit juice? Well, they went one step further than that. They actually also discourage consumption of vegetable juice. To much sugar is the claim. A claim that might be true for beet juice or carrot juice, if however you make green juice using a slow juicer, the micro nutrient sugar ratio is absolutely off the scale. Yes they tell people to eat more vegetables, 250 grams a day to be precise, but they also advocate eating a whopping 200 grams of often sugary fruits like bananas, mango’s etc each and every day. Again both apparently based on very little actual science. If you replace the 200 grams of sugary fruit with 100 grams of lime and berries, you could easily juice a full litre of above ground, mostly green, vegetables and get the same amount of sugar at many times the vitamins and other important and beneficial micro nutrients.  Note that I’m not suggesting that people need to drink a litre of veggie juice each day, just that veggie juice as a whole should not be on any black list, and there is no actual substantial body of evidence supporting any beneficial effect of choosing fruits over vegetables for more than a single serving a day.

We already talked about processed grain where the Voedingscentrum ignored their own core stand against processed foods, but it gets worse. In the previous guideline the dietary advise was to consume fish twice a week. The revised guidelines have reduced that to once a week. In an other part of the guideline, the use of vegetable oils is promoted. Next to these vegetable oils being classifiable as highly processed oils, and thus not in line with the base stand against processed foods, there is something that makes this a serious step back from a health point of view. In recent years, the role of inflammation as major health risk has come to light, and the ratio of omega 6 to omega 3 intake plays a major and unmistakable role in inflammation. Less fish means less omega 3. More vegetable oil means more omega 6. Combined result: the omega 6 omega 3 ratio shoots up. A healthy ratio should normally be somewhere between one and three. Raise it an order of magnitude and mortality rates shoot through the roof. These two guidelines combined thus are not just poor advise. They combine into potentially deadly advise working directly against the excellent advise to eat more whole foods, avoid fruit juice and eat more nuts and legumes.

To summarize the bad part:

  • Massive amounts of (full grain) processed wheat products.
  • A NO for vegetable juice
  • Worse Omega 6 / Omega 3 ratio when compared to previous guidelines.

The ugly

Much of the avoid this and limit that advise in the guidelines stem from the combination of two ideas:

  • Saturated fats raise bad cholesterol (LDL).
  • Bad cholesterol raises the risk of heart disease.

At fist glance a large body of research seems to agree with these two ideas and with the idea that as a result saturated fats raise the risk of heart disease. If however we look closely at most of the research one thing stands out, most of the research that supports this link can be linked in one way or the other to pharmaceutical companies and the promotion of statin drugs. Statins are a drug that reduce the bodies own cholesterol production and as a result lower the blood cholesterol levels, and in clinical trails a modest reduction of cardiovascular events has repeatedly been seen with the use of statins. In recent years however, it has been discovered that statins also have anti-inflammatory properties, and produce other effects that could reduce cardiovascular events. Taking that into account, proof that the LDL lowering property of statins is in any way related to the modest results of this drug has basically evaporated. In fact, statins can now be actually be considered the most convincing proof that just lowering LDL cholesterol, either by dietary or drug intervention has zero effect (at best) on heart disease mortality.  Recent studies even suggest that LDL particle size may be an important factor, while other studies underline the role of inflammation. Both factors where saturated fat actually does better than both processed vegetable oils rich in omega 6 and full grain wheat flour that are so actively promoted as being heart healthy. Basically we should face up to the fact that statins are probably the biggest scam in the history of the pharmaceutical industry, and as a result we should just throw away a large body of tainted science and start over. Organizations like Voedingscentrum however stick to the tainted research and as such tainted science spreads from pharma to nutritional science leading to dietary advise that, in an attempt to reduce the cardiovascular epidemic actually may end up contributing to it. Let me sum up:

  • LDL-c is an established  risk MARKER for cardiovascular disease.
  • Evidence showing intervention in LDL-c reduces cardiovascular events is all statin based evidence.
  • Meta analysis of statin studies have shown the positive effects of statins to be minimal
  • Non cholesterol related effects of statins have been found that could more than explain for statins positive effects without any effect from the cholesterol lowering properties of statins.
  • Statins are most likely the biggest scam in the history of the pharmaceutical industry, yet much of nutritional science builds upon statin infomercials posing as real science.
  • LDL size has been identified as a stronger risk marker than LDL-c. Large size being good, small size being bad.
  • Inflammation has been identifies as a risk marker as well.
  • Saturated fats improve LDL particle size profiles.
  • Vegetable oils are significantly more pro-inflammatory than saturated fats, and  so are processed grains.

Non of this is Voedingsentrum’s fault of cause, it’s a giant stain upon the field of nutritional science that may take many years to clean. By that time however, many people may have already died prematurely from a guideline that bans innocent saturated fats for its LDL link and promotes foods that through their inflamation link may be much more dangerous.

To summarise the ugly parts:

  • A big NO for SFA
  • A big yes to a multitude of inflammatory food choices.

Conclusion

The bad is pretty bad and the ugly is terribly ugly for sure. The focus on whole foods and the guidelines on fruit juice, nuts and legumes taken together however, I must admit I’m still rather positively surprised about the new guidelines.  A critical note so to speak, not just for the Voedingscentrum, but to nutritional science as a whole that has been duped by statin infomercials into believing LDL-c to be a useful control. Inflammation and metabolic syndrome should absolutely be a bigger concern in future guidelines than saturated fats, and both full grain and fruit intake lack the scientific data to truly support having them in such large quantities. Having said this however, kudus for the good parts, especially the stand on whole foods. If whole foods would include grains and fats it would be that much better though.

This entry was posted on 23rd March 2016. 2 Comments