The FDA has released new statin drugs to be used on a high-risk segment of the population who have genetically high cholesterol, called familial hypercholesterolemia that runs in families. These drugs have been fast-tracked to be introduced strictly to a high-risk population. Smaller trials have been done, but the results of larger trials are only going to be available in 2017. This leaves the uncomfortable question, whether we are observing experiments on humans with new statin drugs, when the final word has not been said.
There was a news release about this story. There are a number of new super cholesterol lowering drugs that have to be given by injection and that reduce the LDL cholesterol fraction, which when oxidized is causing hardening of the arteries very quickly. What made the news right now is Amgen’s drug, evolocumab and Sanofi and Regeneron Pharmaceuticals’ drug, alirocumab. The traditional thinking is that when you lower the bad LDL cholesterol you would save the patient from heart attacks and strokes. I have blogged about the cholesterol story and statins in November 2013 pointing out that statins can hurt the consumer. One concerning side effect of statin therapy is myopathy, a painful muscle disorder where statins have to be discontinued.
Cholesterol is vital for cell function, for insulation of nerve fibers (myelin sheaths) and for synthesis of our steroid hormones (sex hormones and vitamin D3, now considered to be a hormone). The medical establishment took most of the information regarding heart attack and stroke prevention from the ongoing Framingham study. This clearly pointed to the importance of lowering the LDL cholesterol fraction (the “bad” cholesterol) and maintaining or increasing the HDL fraction (the “good” cholesterol).
The problem is that LDL cholesterol is actually an important cholesterol fraction that the body uses as transport molecule to be delivered to all vital organs like the heart, the skeletal muscles and the brain to replace lipids in cell membranes. LDL cholesterol cannot be simply labeled as the “bad cholesterol”. This is an oversimplification.
If we doggedly stick to the assumption that LDL has to be reduced to prevent heart attacks and strokes, we could hurt patients because vital organs may not get enough nutrients to replace their cell membranes. Without cell membranes there is no life!
Some details about what causes heart attacks and strokes
I like to explain how heart attacks and strokes develop. At the center of the problem is how hardening of the arteries develops. In the 1990’s and in the next decade, from 2000 to 2010 detailed research into this has been completed. It has shown that free radicals have a lot to do with hardening of the arteries. There is not one isolated single cause, but a combination of multiple factors that cause hardening of the arteries. One of the key processes is the fact that that in civilized countries too much sugar and starchy food is consumed. This is metabolized into sugar with digestion and absorbed into the blood by the gut. In response to all this sugar the pancreas secretes an overload of insulin every day. The high insulin levels cause inflammation, which releases a number of aggressive molecules that attack the lining of the arteries. Sugar also oxidizes the LDL cholesterol and the HDL cholesterol, which makes the LDL cholesterol more aggressive as it now reacts like a free radical. Macrophages take up the oxidized LDL cholesterol; they turn into fat-laden foam cells, which in turn burrow themselves under the lining of the arteries. Normally the HDL cholesterol incorporates oxidized LDL cholesterol and brings this to the liver for further processing. However, HDL itself is being oxidized by sugar and it loses its protective function. The end result is that hardening of the arteries is accelerated and when a critical point is reached, a heart attack or stroke can occur.
We need to rethink how to prevent heart attacks and strokes
What struck me with the FDA decision is that they seem to doggedly hold on to the hypothesis that heart attacks and strokes develop from LDL cholesterol that is too high. If this were the case, statins would have worked wonders in terms of preventing heart attacks and strokes, yet the number one killer is still hardening of the arteries. What I wrote in my blog in November 2013 is still true.
The solution to preventing heart attacks and strokes may not be attractive to some, but it is found in a proper diet and exercise. Here is the solution:
- We need to cut out sugar and starchy foods. This includes grains. Kellogg’s and cohorts won’t be happy nor will be your friendly baker or the bakery department in your supermarket.
- A Mediterranean diet is now the gold standard and adding olive oil and nuts to it will be even more effective in reducing mortality from heart attacks and strokes.
- Exercise has been proven to elevate HDL cholesterol significantly, so why not do less sitting and do more moving? With having cut out sugar and starchy foods, the HDL will be fully functioning and keep the LDL cholesterol honest, meaning that only non-oxidized LDL will reach the vital organs for membrane exchange work, while oxidized LDL is removed by HDL like a sponge and inactivated in the liver.
This is all: a three-point approach with no statins and no super statins. Big Pharma will not be happy about that, but it has been proven to be effective for several years (Ref. 1, 2 and 3).
What I find particularly concerning is the fact that most of the super statin trials will only come out with the full results in 2017. We witness that the FDA has approved these new super statins to be used on the most vulnerable people (familial hypercholesterolemia) on top of regular statins. I fail to see how vital organs can function, if the diet is not changed. It also is disturbing that CoQ-10 is not given as a supplement to counter at least some of the side-effects of the statins and super statins. No recommendations to that effect were made. I feel that the FDA allows patients with familial hypercholesterolemia to be subjected to a human experiment of this nature. They are receiving drugs that we do not fully know yet. After 2017 we will know whether they have reduced heart attack and stroke rates or not.
I remember very well from the 1980’s when I was in the middle of practicing medicine that we were told through the cholesterol-lowering drug guidelines that we should first assess the patient’s diet and exercise status. If modifying these lifestyle factors were ineffective, we would then only be using the statin drugs to lower cholesterol levels. In the meantime the scenario has changed and experienced a complete reversal in terms of diets. The high carb /low fat diet has been replaced with the low carb/medium fat Mediterranean diet, which by itself can be very effective in reducing LDL cholesterol. Recently research has shown that adding olive oil and nuts can lower mortality from heart attacks and strokes even more. It seems that the FDA is completely ignoring all this research.
I think that physicians and patients alike would do well to remember that it was the introduction of sugar, starchy foods and processed foods into the civilized world about 100 years ago that caused an increase of heart attacks and strokes because of the processes explained above. The real solution is the 3-point program suggested above. This will likely solve 80% to 90% of all cases of hardening of the arteries causing strokes and heart attacks. The rest could be treated cautiously with cholesterol lowering drugs, like the statins, however there is no room for human experiments.
More info on arteriosclerosis (hardening of arteries).
1. Dr. Steven Masley, MD: “The 30-day Heart Tune-Up – A Breakthrough Medical Plan to Prevent and Reverse Heart Disease”, Center Street, A Division of Hachette Book Group Inc. New York, Boston, Nashville, USA © 2014
2. David Perlmutter, MD: “Grain Brain. The Surprising Truth About Wheat, Carbs, And Sugar-Your Brain’s Silent Killers.” Little, Brown and Company, New York, 2013.
3. William Davis, MD: “Wheat Belly Cookbook. 150 Recipes to Help You Lose the Wheat, Lose the Weight, and Find Your Path Back to Health”. Harper Collins Publishers LTD., Toronto, Canada, 2012.