What am I missing here? Has it not been proven that Statin + Niacin combo is like 90% affective in stopping plaque progression in its tracks? Why does that not say that LDL reduction AND particle size reduction,(Niacin for LP(a),works best? Its not just LDL, I developed heart disease with a 90-100 LDL before my Dr discovered  high LP (a). Treated with 10mg statin,1500 Niacin, diet,I am at a30/30 count. OVER&OUT

Let's just summarise. First there was Keys with his total cholesterol. This turned out to be garbage. Then there was LDL vs HDL. But LDL is calculated and, as we know from this site, tells us nothing about anything. Then we have LDL particle size. Small dense is bad, big fluffy is good, noting that big fluffy contains lots of cholesterol per particle and can increase your calculated, or even absolute, LDL. Two factors, most studies use calculated LDL. The bin is there, file promptly.

The second is that something controls your LDL particle size. How, on a practical basis, does Dr Davis control LDL size and density? No wheat and no sugar. Does wheat and sugar elimination alter anything in the body? Wheat contains both an insulin mimetic and two insulin potentiators, plus starches and sugars both increase blood insulin levels per se. Perhaps there is a message here. It's been known for decades that insulin drives the proliferation of the arterial media we call arteriosclerosis.

If insulin also controls LDL particle size (I have no information on this, but I'm willing to bet it does) then Yudkin and Stout are correct, Keys is wrong and the cholesterol hypothesis, what remains of it, describes the effects of insulin on blood lipids. While insulin and glucose do the damage to the arteries.

Just a cholesterol skeptic view.

Peter

Statins are anti-inflammatory, antioxidant, anti-proliferative and probably anti other things too. Unfortunately they drop cholesterol levels (in humans anyway). Zetia, like torcetrapib and clofibrate, does the cholesterol dropping thing without the anti everything else that statins bring along. No wonder they killed so many people in the clinical trials. Clofibrate. Torcetrapib.

If a drug company develops a drug which converts small dense LDL to light fluffy LDL without affecting insulin sensitivity or glucose, I predict it will go the way of clofibrate and torcetrapib. There's the bin.

I especially find it interesting that, among the so-called pleiotropic, or non-lipid, effects of statin drugs is a modest rise in 25-OH-vitamin D3 levels.

I think this just once again shows that statins DO reduce heart disease but NOT because of the reduction in LDL. I'm always amazed at the Dr. who say you don't need to be on a statin your LDL is fine. Statins have been proven to reduce death rates in cardiovascular disease by 30 to 40% and yes with niacin by 90%!!!!!!!! Anybody worried about heart disease should be taking them. And save me the "side effects" alarm of statins that is so over blown. The fact is we invented a drug to reduce LDL, it does that but thats not why it reduces heart attacks and we're still not sure why they do. We accidently created a great class of drugs.

I remember in Taubes reading that small LDL are the result of particles being formed in a high-triglyceride environment--if so there is a more direct link to diet than through insulin.

About the merits of statins, can't we at least say that through reducing the number of all LDL particles and hence the number of small particles arteries are protected?

Keith

The drug company slanted this study so that they'd get a wonderful result, that they didn't and the lengths that they went to hide or misrepresent the data that came out of the study has to make you suspicious of what ELSE they have learned.

Did you catch that they also suppressed other study results showing liver damage from Zetia?

Also, did you catch the BMJ story today about the calcium supplementation trial that lowered LDL raised HDL and increased cardiac and stroke events in older women?

While that too isn't a death blow to the LDL hypothesis, it certainly doesn't bolster it.

Peter,

Good post; you have an impressive grasp of the literature on this!  I have a question for you, though:  Besides the epidemiology (which I know you don't buy), aren't there still tons of animal studies linking atherosclerosis to dietary saturated fat?  In fact, to promote atherogenesis in lab animals so they can study it, don't they feed them a diet rich in palmitic, stearic, myristic and lauric acids from animal and tropical plant fats, which works predictably?

Drug companies are actually scrutinized fairly closely, though plenty of shenanigans still go on.

What scares me even more is what may have been going on BEFORE the intensified scrutiny began a few years ago.

Nowadays, the return on investment for treatment of chronic diseases like cholesterol, osteoporosis, and hypertension are so substantial that it is causing them to see a blur between right and wrong.

Yes. I believe that the evidence for that effect of statin drugs is quite confident.

When I question the Lipid Hypothesis, what I really mean is that I question the wisdom of the simple "high cholesterol means more atherosclerosis" philosophy, a belief that is clearly oversimplified, though it contains a germ of truth.

For anonymous,

Of course statins reduce cardiac mortality and obviously it's nothing to do with LDL cholesterol lowering. But before you pop one on the off chance (they are available OTC in the UK) go very carefully through this paper.

You need the full text, the abstract tells you nothing, so here's a summary:

There were 2913 patients in the placebo group. A total of 306 died during their 3 years of not taking a statin. That is 10.5% died. In the treatment group there were 2891 patients and 298 died, that's 10.3%. Bear in mind that these were high risk cardiovascular patients, the sort for whom statin therapy is supposed to be effective in saving lives.

There was undoubtedly a significant improvement in cardiac mortality WITHOUT improvement in overall mortality. To sum up the PROSPER trial, you can have the cause of death changed from heart attack to cancer, but not the date on the death certificate. You choose. Perhaps you're too young to be in the PROSPER trial, but live long enough and you won't be!

PS if you EVER see a statin trial without the overall mortality figures, just assume there was no benefit or worse. If there is even a miniscule benefit it will be broadcast far and wide.

Keith,

Thanks for the pointer. Obviously high triglycerides are a classic marker of hyperinsulinaemia and insulin resistance. I'll follow that one when I get that far in to Taubes' book. Seems it's looking good for Yudkin.

bad_crc,

Yes, there are thousands of papers like that. They usually use D12451 or something like it. High fat alright, 45% calories from lard. As the rest is? A bit of corn starch, a mass of maltodextrin and an even bigger mass of sucrose!!!!! But of course it's the lard that kills....

Whereas using a real high fat diet you get this paper. I would suggest the 60% of calories from fat us a little low for a rodent. Choosing for themselves they can go to around 80%, get plump but don't develop insulin resistance.

Peter

My understanding is that studies show that statins are effective in reducing heart attacks ONLY in people who have already HAD heart attacks. Not in the general population.

This would confirm the growing suspicion that statins work by limiting the inflammation associated with heart disease. Not through their effect on lipids.

To get back to Zetia/Vytorin, what Dr. Nissen pointed to, which IS in my mind worth noting, was that while the variation in individual endpoints did not rise to statistical significance every single endpoint measured went in the wrong direction. That argues against random effects in my mind.

Beyond that, we know that in most people heart disease develops over a longer period than that spanned by this study, which only lasted 2 years. If all these parameters measured were trending negatively at 2 years, what happens at 5? Or 10? This is one of those drugs that once they put on on it, you take them forever. So the 5 or 10 year result could be devastating if this turns out to be a significant finding.

My suggestion would be continue testing this drug in small studies involving people who are very well informed of the risks, but end the writing of the current 1 million prescriptions a month. That's a LOT of guinea pigs, and if there turned out to be an accelerating pace of problems with it, a lot of people could die unnecessarily.

Statins reduce the number of LDL particles, which is very poorly represented by the conventional (Friedwald)calculated LDL cholesterol.

More importantly, when someone with heterozygous hypercholesterolemia (as in this Vytorin study) has a high number of SMALL LDL particles, then statin drugs, in my view, do provide benefit. But a superior effect would be to specifically reduce the number of small LDL particles, best accomplished with such strategies as elimination of wheat, weight loss via low carbohydrate diet, fish oil, vitamin D, and niacin.

This raises the question of how well the two groups in this study were matched for the number of small LDL particles. To my knowledge, this was not measured.

Let me also remind everybody that the measure obtained and used for comparison was carotid IMT, not carotid plaque.

I'm certain I'm not alone in feeling bewildered that such a dominant theory of the disease could turn out to have been so wrong for so long at such great cost in lives and treasure.

Just as a question of historical interest, how far back in the history of science do we have to look to find this kind of reversal of understanding of what the facts are with such broad and great consequence?

Hi, WC--

I'm not sure, but it's not the first time.  

Is the earth still flat?

Hi Dr. D.

I was thinking of Galileo also and his remarkable discovery that the earth orbits the sun.

But then I thought "surely we don't have to go that far back do we to get to such a broad and consequential paradigm shift?"

Maybe we do.

Could zetia be interfering with the absorption  of simvastatin?

Hi wccaguy,

You may enjoy this discussion article from PLoS. The authors intend it to be provocative, put it does pose the question "on which day did medicine stop making mistakes?"

Peter

In response to Jenny, not all studies on reducing heart attack death havwe been done on people who already had a heart attack. The reduction of 30 to 40% is whether you've had one or not.

Our saturated fat question keeps coming up, but the current common wisdom is that saturated fats are "neutral" in the sense that they raise both LDL and HDL. But do we know what they do to the number of small particles? Of course, if LDL is raised by making particles fluffy then saturated fats are clearly protective.

Keith

Hi, Richard-
No, there was indeed a substantial further drop in LDL with Vytorin over simvastatin.

There is a very modest shift from small to large LDL.

Zetia dropped my very high, inherited LDL to normal, BUT I afer a couple months on Zetia my post-menopausal body stopped making estrogen--my gynecologist remarked on it.  

I also started having a problem with persistent visual afterimages which the ophthalmologist said might also be from having too little cholesterol.

Both problems went away when I stopped the Zetia. I have very high LDL but I also have the "longevity" cholesterol gene which makes for big fluffy LDL as well as very low Apo(b). My doctors--including the cardiologist I saw--are ignorant about the implications of both findings and just obsess about the high LDL.

Since naturally produced estrogen seems to be protective for heart disease, I wonder if some people with inherited high LDL are like me have the large fluffy LDL molecules which give a deceptively high LDL value on tests. For them lowering it with Zetia drops LDL TOO low, so that the body doesn't have the cholesterol it needs for important functions, like making the naturally produced female hormones that may be protective against heart disease.

Hi, Jenny-
Keep in mind that conventional LDL is a flagrantly inaccurate number. In my experience, LDL of 150 when accurately measured (we use the NMR LDL particle number as the "gold standard"), the true number is between 80 and 270 mg/dl.

In my view, conventional LDL is a silly number. It is also the basis of a $23 billion (annual revenue) industry.

In Dec 05 I had a heart scan score of 145.  I went from 10 mg of Lipitor to 80mg of Vytorin and 1000 Niacin, 1 fish oil.  At that time my particle number was 1325 and small particle # 977.  A year later it went to 1503/1277.

In Nov 07 my heart scan went to 291. I then went to 2000 mg of Niacin and 150 COQ10,4 fish oil, 500 mg C, Vitamin D.

My new liposcience profile taken Dec 27 07 shows small particle down to 249 and particle number down to 279.

I dont know why my plaque increased so much but the new lipo profile is impressive in reduction.

Is there anything here that seems weird or is it just the plaque grew fast and is likely now under control with the much improved scores?  All other factors on the profile were great and my Vitamin D is very good and CRP excellent too.  My homosistine was 15.7 is the only thing a bit high.

Thanks!!

Sorry, but I do not assess entire programs on this blog.

I would invite you to participate in the conversations in the Track Your Plaque Forum for detailed discussions like this. There is also a free report on "10 steps to take if your heart scan score increases" on the www.trackyourplaque.com website.

I would not automatically conclude that Zetia causes carotid plaque. This is absurd. And I am definitely not one to come to the rescue of a drug or drug manufacturer. I am simply after understanding and truth.

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Probably probably the most helpful in addition to up-to-date info I came across on this topic. I am positive fortunate that I noticed your article by chance. I¡¯ll be subscribing to your individual rss feed in order that I can have the most recent posts. Take pleasure in all the pieces here.

Being Irish an' all, my jeans will only allow me to thrive on a few spuds served with lashin's of butter an' onions and o' course sides of bacon and eggs washed down with Whiskey Go Leor, sometimes called The Juice o' the Barley.

Minimal wheat.

It only makes sense that there are vast numbers of people actually addicted to food, not metaphorically, but in the same way people are addicted to drugs and nicotine. A good start would be stop subsidizing this addiction, but since we have a government of the grain farmers, by the grain farmers, and for the grain farmers, that's not likely.

Is wheat induced brain damage reversible, if one goes off wheat say at 50.?

I would bet good money that this post will get more people off wheat than all your posts about wheat and heart disease combined!

You are totally right the devastating effects of wheat and its palls goes from gut to brain http://bit.ly/cAbZry VBR

Dr. Davis

As usual you are SPOT ON. exactly right with the symptoms and age. Just amazing all clinical symptoms described were seen by me in my father from 53 (stumbling and falling) to 58 (requiring help walking) to 60 (epilepsy hallucinations and fears)to 61 (bedridden) to 64 (last year November) death.

Come to think, it was so simple to save him. It is just unreal.

Sprouted wheat however is I believe extremely good for health.

YOU HAVE DEFINITELY MADE YOUR POINT QUITE CLEAR.  NO NO MORE WHEAT.

Does anyone how tequila is made?

No wheat in tequila

Is it time to join the bandwagon? No more drinking, no more smoking, no more wheat? Really, did I just write that? I have to say, I really enjoy my PB&J on whole grain wheat bread, as do my kids.

Eating wheat is like apple pie and July 4th fireworks. How can we possibly do without and find a relatively cheap substitute? Is rice any good or is that a bad carb too?

To eat healthy, is it just you need to eat organic and nonwheat foods and watch your carb-mix?

Does it have to be this complicated? Has anyone written a book with easy to find, cheap/healthy ingredients that is easy to prepare in 30 minutes or less and feeds a family of 4?

Right now, we're basically down to grilled chicken/fish/pork with steamed fresh brocolli/green beans and long-grain rice. That's pretty much all we eat anymore, with the occassional cheeseburger/steak indulgence.

I started Low Dose Naltrexone 2 months ago to help with Autoimmune Disease.  I started at 1.5 and now am at 3.0
I will increase to 4.5 in 2 weeks.

I eliminated grains and dairy 1 month ago.

I have lost 10 pounds.

I could be as simple as the diet changes but I think more is going on.

I have less pain which allows me to sleep through the night.
I have more energy.
I am more active and actually exercising.
I am supplementing Vit. D and getting daily sun exposure (my Vit. D level was 41).
My moods have greatly improved.

Ironically, any time I have been prescribed an opiate pain medication, I have had severe allergic reactions.

As far as the Neuro symptoms, I do have Meniere's complete with dizziness and vertigo.  So far I have not noticed any positive impact but still hopeful.

Thanks Dr. Davis for all your information.

J9

"This results in stumbling, incoordination, incontinence, "

I know you are right on. I was having mild ataxia and stress incontinence. Off gluten for 7 years and balance is better and no stress incontinence.

This also affects dogs. My 12 year old cairn terrier was stumbling, falling over and urinating in her sleep. Got her off grains 2 years ago and she improved immediately.

I can not say it enough times..............  Be healthy, not Paranoid.

Dr. D emphasizes extremes for effect.  Do not fall into either side of the trap. Complacency nor paranoia.  informed decisions are critical for you and your family's well being

Trevor

i'd agree with Trevor as well.

sourdough wheat (traditional preparation) and boiled raw milk go together.

sourdoughing helps breakdown anti nutrients in wheat making the nutrients more bio available. Further Raw milk takes care of the rest by providing necessary enzymes (phystase etc) to digest wheat completely.

pasteurized milk and wheat consumed without sourdoughing give both milk and wheat a bad name and will improve health when stopped simultaneously.

traditional preparations eliminate such problems to a large extent.

Celiac disease is a digestive disease that damages the small intestine and interferes with absorption of nutrients from food.  Is an inherited, autoimmune disease in which the lining of the small intestine is damaged from eating gluten and other proteins found in wheat, barley, rye, and possibly oats.
celiac disease symptoms

Sprouting wheat begins the process of breaking down gluten, but it is not a complete process. Same goes for fermenting. Making a suboptimal food less bad for you does not mean that food is now good for you.

As for boiled raw milk, taking raw milk to a boil heats it to an even higher temperature than is done during regular, non-UHT pasteurization, and it keeps it at that high temperature for a much longer time than any commercial pasteurization process. Raw milk that's been pasteurized at home at a higher temperature for a much longer time is not somehow magically superior to commercially pasteurized milk.

I'd personally like to see an experiment on sourdough whole wheat combined with boiled raw milk to see what Dr Davis notes. That should settle it.

Alex share your experience rather than float around in clouds.

Just out of curiosity, I would like to know what is the point of buying something raw (supposedly because "raw" holds more benefits) only to then get it home and cook it. Boiling raw milk, in my estimation, defeats the purpose of consuming raw milk. Boiling kills everything. I buy raw milk weekly and I drink it "raw." That's why I buy it.  
Am I missing something? (serious question).

Anonymous, I don't have acute gluten sensitivity, but I've read enough about gluten sensitivity to know that sprouting and fermentation are not 100% effective at making wheat a tolerable food for people with gluten sensitivity.

Why cling desperately to consumption of a crap quality food when it's so much easier and simpler to just not eat it at all? One personal experience I can draw on is the addictive nature of wheat. I've been addicted to both tobacco and alcohol, but the most addiction-triggering image I can visualize in my mind is a loaf of locally made, crusty Italian bread. I think people cling to wheat consumption because it's addictive, plus it's deeply embedded in human culture.

raw milk is a relatively new fad in usa while india is the highest wheat and milk consumer since hundreds of years. The way they consume raw milk, is, after boiling it and the way they consume whole wheat is after making sourdough.

I personally consume raw milk without boiling but whats important is to understand the effects of consuming wheat and milk traditionally on health viz a viz consuming it in modern style.

Alex wheat is sub optimal as are many other foods. the only complete food is milk, everything else is had in combination with a complementary food.

Wheat is also not easy to avoid while its consumed traditionally  daily in the east, it is everywhere in its modern avatar in the west.

its not a bad idea to figure out wheats' complement and how it works than declare wheat suboptimal and write it off.

I think that more than the problems wheat may cause for some, the problem is the amount of wheat we consume. Consuming the bulk of your calories from wheat (or grain) is a problem, even for those who don't have any existing conditions. Drinking beer all day or more than you should isn't good either but that doesn't mean that a beer here and there or even one per day is a big deal. For an alcoholic one beer is a bad thing but for the average person 1 or 2 isn't. For someone with a problem, wheat is bad; for the average person a little here and there in moderation isn't. There are a lot of things modern man eats that he didn't eat at one time. But then again, there are many things in life in general that modern man does that we didn't do years ago. We will always look to make things easier and in doing so compromise ourselves in some way. The best thing is to be educated enough to make good decisions but not get too carried away in either direction.
Eating store bought chicken and meat tainted and chemically enhanced isn't good either. What does that do to us long term? What about our children. Eat less wheat and grains and avoid one illness but get another from mystery meat. So I guess we can't win no matter what we do. We can't get crazy, we just have to make good decisions.
Middle of the road always seems like a good starting point.

"The most common immune neurological syndrome consequent to wheat consumption is cerebellar ataxia"

Where is the study or other reference that supports this statement? How common is this neurological syndrome in the American general population?

Thank you.

How exactly are the Purkinje cells damaged, and how specific is the effect to gluten/wheat?  What is your source for this?