Super size me in little bits and pieces



Alvin came into the office for consultation on his cholesterol values: LDL 198 mg/dl, HDL, 43 mg/dl, triglycerides 143 mg/dl. He says that he doesn't really try to choose healthy foods but he restricts his overall calorie intake by following the Weight Watcher's exchange approach.

Every morning, 7 days a week, Alvin eats a Sausage McMuffin for breakfast. He justified this by skipping lunch to make up for the 450 calories in the Sausage McMuffin, and not eating anything until dinner.

Can this work? Can you eat foods with unhealthy ingredients but make up the excessive calories by cutting back elsewhere?

The nutritional composition of McDonald's Sausage McMuffin includes 27 grams of total fat (10 gm saturated); 255 mg cholesterol; 950 mg sodium; 31 gm carbohydrate; 2 grams fiber. In other words, it's essentially the same as butter with sugar on it--pure fat, processed wheat, with little fiber or nutritive value.

For Alvin, this is an extremely unhealthy way to eat. His lipid patterns are just the tip of the iceberg: multiple hidden factors are also at work to create heart disease, atherosclerosis in other territories outside the heart, diabetes, high blood pressure, and cancer.

I think the effects are not much different than what Morgan Spurlock achieved in his Super Size Me documentary, but in little bits and pieces. Eating at McDonald's "restaurants" three times a day yielded frightening changes in his lipids, liver function, kidney function, not to mention his appearance and the way he felt. Alvin is doing the same thing, though in less dramatic fashion.

I see this very frequently: people mimicking the experience of Spurlock, just a little at a time, with overindulgence in processed fats and starches.

When you seen a set of Mcdonald's golden arches (or any fast food restaurant, for that matter), run as fast as you can in the other direction. Such indulgences, even in small bits and pieces, still creates a mess of your health.

View from the precipice


Many people, upon first learning of their CT heart scan score, feel like they're on the edge of a sharp drop. It can feel like you're facing a vast, unknown abyss. At the bottom, all those dreaded things that can happen to you: heart attack, heart failure, hospitals, even dying.

I've encountered this "deer in the headlights" look many times. It truly can be frightening to hear that your heart scan score is 300, or 500, or whatever.

What I find truly frightening, however, is when your score prompts the usual array of misinformation commonly dispensed by physicians: "That's so bad you need a heart catheterization", "Nobody knows why people get calcified plaque", or "Reversal is impossible". All absolute bunk.

Let your fear motivate you to do something about your risk for heart disease. Aim for reversal of your coronary plaque and seek out the tools to achieve this. It is possible and, in fact, we do it all the time. I can't claim 100% success, but the majority of people who engage in an effort like the Track Your Plaque program to reverse coronary plaque succeed. Even a substantial slowing of plaque growth from the expected 30% per year is better than submitting to the conventional approach.

At the very least, get both LDL and HDL cholesterol around 60 mg/dl. This alone is a major plus in reducing the risks associated with your heart scan score. It doesn't guaranteee reversal, but it sure tips the odds in your favor.

Organic Rice Krispies?



Breakfast cereal manufacturing giant, Kelloggs, is launching a line of three cereals that will carry the "organic" designation: Organic Rice Krispies, Organic Raisin Bran, and Organic Frosted Mini-Wheats.

This reminds me of the advertisements I've seen for "fresh fried chicken", or "fresh from the can", or "contains only pure cane sugar". How about organic tobacco? Would that make cigarettes healthier?

The TV ad ends with the slogan "Childood is calling!" Oh, those marketers are a shrewd, clever bunch. I worry that they're so clever that most people will fall for these ludicrous tricks.

Don't fall for these thinly-shrouded marketing shenanigans. Organic? Who cares. These foods remain unhealthy whether or not they contain pesticide residues. Take a look at the nutritional composition: Rice Krispies, organic or not, is sugar to your body. It is the sort of food that creates pre-diabetes, diabetes, makes us fat, and fans the flames of lipoprotein patterns like small LDL, VLDL, and postprandial particles, all of which is like throwing cow manure on the weed patch of your coronary plaque.

Nuts as functional foods

Food manufacturers gave nuts a bad name when they started adding evil ingredients to them. "Party mix", "honey-roasted", mixed nuts, etc., are made with added hydrogenated oils, salt, sugar, excessive quantities of raisins, or other added ingredients that turned a healthy food--nuts--into something that made us fat and hypertensive, raised LDL, dropped HDL, and raised blood pressure.

But nuts themselves are, for the most part, very healthy foods. The very best are nuts with a brown fiber coating like almonds, walnuts, and pecans. Nearly all nuts also come rich in monounsaturated oils similar to that in olive oil. Although calorie-dense, nuts tend to be very filling and slash your appetite for other foods. I have never seen anyone gain weight by adding raw nuts to their diet. In fact, I find adding raw nuts cuts craving for sweets.

Nuts are also among the most concentrated sources of magnesium, containing around 150 mg per 1/2 cup serving. As most Americans are at least marginally if not severely deficient in magnesium, this really helps. Magnesium deficiency is a prominent aspect of "metabolic syndrome" and resistance to insulin.




Some nuts have added benefits like the l-arginine content of almonds or the linolenic acid content of walnuts. However, I think the real health "punch" comes from the fiber and monounsaturate content.

Add 1/4-1/2 cup of raw almonds, walnuts, or pecans per day to your diet and what can you expect? The effects that I see every day that are relevant to plaque control/heart scan score-reducing efforts include:

--Reduction in LDL--usually a 20 mg/dl drop, sometimes more.

--Reduction in triglycerides, especially if nuts replace processed carbohydrate calories. This may be because the fiber and monounsaturate content of nuts reduces blood sugar and the effective glycemic index of any accompanying foods.

--Modest blood pressure reduction.

--Though somewhat inconsistent, partial suppression of the dreaded small LDL particle pattern. We struggle with turning off the small LDL pattern in some people, and raw nuts can provide a real advantage.

If that isn't enough, the fiber content also makes your bowels regular.

Unless there's some reason to avoid nuts (e.g., allergy), nuts should be a part of your heart scan score reducing program. Shop around, as prices can vary wildly. I've been paying $12.99 for a 3 lb bag of raw almonds from Sam's Club, though I've seen almonds elsewhere for up to $12.99 per pound.

For additional commentary, go to one of my favorite Blogs, http://fanaticcook.blogspot.com. The Fanatic Cook's recent post, The Season for Walnuts , provides additional discussion on walnuts and the recent study showing how they improve "endothelial function". The nutritionist behind this Blog has fabulous insights into food, including the concept of "functional foods", i.e., using foods as a treatment tool. She is also unfailingly entertaining.

Can you tell the difference?

Stan is 55 years old. He feels fine, is in moderately good physical condition. His LDL cholesterol is 135 mg/dl, HDL 43 mg/dl, triglycerides 167 mg/dl, total cholesterol 211 mg/dl.

Can you tell me whether Stan has heart disease or not?

How about Charles? Charles has an LDL cholesterol of 127 mg/dl, HDL of 44 mg/dl, triglycerides of 98 mg/dl, and total cholesterol of 191 mg/dl. He is also reasonably fit and feels fine. Can you tell whether Charles has heart disease?

If you can't, don't feel bad. Neither can your doctor. But this is the folly of using cholesterol for risk prediction.

Stan's heart scan score: 0

Charles' heart scan score: 978

Look even more closely at Stan's and Charles' cholesterol numbers. Is there some fine distinction we overlooked? What if we calculated total cholesterol to HDL ratio? Or LDL/HDL ratio?

No matter how you squeeze it, shake it, beat it with a stick, you simply cannot use cholesterol numbers to predict heart disease in specific individuals. Yes, the higher your LDL cholesterol and lower your HDL, the higehr your total cholesterol to HDL ratio, the greater the likelihood of heart disease. But you can simply cannot tell in a specific individual at a specific point in time. If you've seen your doctor puzzle over the numbers, understand that he/she is trying to make sense out of something that doesn't make sense, no matter how hard he/she tries.

You simply need to measure the disease itself: get a CT heart scan, the only measure of atherosclerotic coronary plaque that you have access to.

By the way, if you haven't seen it yet, go to the Track Your Plaque website (www.cureality.com) to see the news piece reporting the American Heart Association's much overdue position statement on CT heart scanning. The AHA has finally released a statement which, in effect, provides their "official" endorsement. Blocked by political shenanigans behind the scenes for several years, the guidelines finally made it to press. The only real difference it makes to me is that my patients may finally get their heart scans paid for by insurance, once the insurance companies realize that it's getting tougher and tougher to dodge their responsibility.

Statin agents and muscle aches

How common are muscle aches with the statin drugs?

It depends on who you ask. If you ask the drug manufacturers, they will tell you no more than 2% of people who take them. They back this up with the experience in tens of thousands of people in published clinical trials.

What if we ask people who take them outside of clinical trials. How many then? I estimate, from my large experience, over 80%! In other words, muscle aches are inevitable in nearly everyone who takes them. The longer you take them, the higher your dose, the more likely muscle aches are going to be.

Why the disconnect between published data and real-world experience? I really don't know. In some instances, the differences are dramatic. The ASTEROID trial, for instance, in which Crestor, 40 mg, was given for two years, only resulted in 8% of people dropping out because of side-effects. My experience: everybody--nobody can tolerate this dose for any length of time.

Let me qualify what "muscle aches" mean. It means achiness and/or weakness, usually mild, occasionally moderate to severe, worse upon awakening and less with use. It can affect many muscles or it can involve only one. Rarely is it incapacitating but it is commonly annoying and frightening. It commonly shows up as gradually diminishing strength with exercise. Strength usually returns promptly upon stopping the offending drug.

"Rhabdomyolysis", or true muscle destruction is, fortunately, very unusual in otherwise well people. People with abnormal kidney function, diabetes, and other concurrent illnesses are somewhat more prone. But in reality, rhabdomyolysis is unusual. I've personally seen it twice, both in people sick for other reasons.

Coenzyme Q10 (CoQ10) supplementation has been a godsend for us. At least 4 out of 5 people who require statins and develop muscle aches respond favorably, but it requires 100 mg per day. The preparation must be oil-based to work, not powder in a capsule which exerts no effect. Some people get by with less; some require as much as 300 mg per day. I've had favorable experiences with the CoQ10 from Sam's Club, GNC, Vitamin Shoppe, and Life Extension (www.LEF.org).

The Track Your Plaque target for LDL cholesterol is 60 mg/dl. Many people do indeed use statins to achieve this level, the level of LDL that amplifies your chances of heart disease reversal, i.e., reduction of heart scan score. The only drawback that I'm aware of with CoQ10 replacement is cost. Beyond this, it's a benign supplement that even supplies higher energy for some people who take it.

More catheterizations would make me happy!

I received this fax today from a cardiologist seeking a position:

"I would prefer to perform as many interventions [stents, angioplasties, etc.] as possible..."

That about sums it up, doesn't it? The goal of this young man, trained in major universities including Columbia University, Harvard, and Emory, is not to pursue an avenue of investigation or healthcare that yields real answers. His goal is to perform as many procedures as possible.

This attitude is deeply ingrained in cardiologists. It's also shared by all procedural medical specialties: the drive to do more and more procedures. It's not because it does more good for the public, but it fulfills a primitive impulse to spread your influence, enlarge your territory, and--of course--make more money.

Personally, I find this impulse repulsive. The fact that this young cardiologist looking for a position is willing to make this statement out in the open demonstrates how widely accepted this attitude is. Imagine your cancer surgeon, looking for a new job, said, "I'm looking to remove as many tumors as I can."

My colleagues have lost sight of the fact that we're trying to reduce or eliminate disease, not enrich our pockets or service some primitive impulse to beat others at our game.

"I hate fish oil!"

I get this comment occasionally, usually from the fishy belching that can occur, rarely because of other crazy effects like rash, fishy body odor, etc.

In the vast majority, fish oil is a benign but wonderfully effective agent. Track Your Plaque followers know that fish oil, starting at 4000 mg per day of a standard 1000 mg capsule preparation, dramatically reduces triglycerides and thereby raises HDL, partially suppresses small LDL, and is the best agent available for reducing postprandial (after eating) abnormalities like IDL and certain VLDL fractions.

However, an occasional person (about 1 in 20) just doesn't like the effects. Are there alternatives? Fish oil packs such a wallop of beneficial effects that can not be replaced by any other single agent or lifestyle practice. For this reason, we have a number of easy strategies to enhance your tolerance for fish oil. (Of course, if your and/or you doctor determine that you're allergic to fish oil, then you should indeed avoid it; thankfully, this is rare.)

Helpful strategies include:

--Refrigerate fish oil capsules--this cuts back on fish belching.
--Take only with meals. This also may increase fish oil's benefits on suppressing after-eating lipoprotein abnormalities.
--Take an enteric-coated preparation--this delays breakdown of the tablet/capsule, making fishy belching less of an issue. Sam's Club has an inexpensive preparation.
--Take liquid fish oil. Usually orange or lemon flavored, liquid fish oil may be a faint fishy taste and odor, but usually not as prominent as the capsules. There's also less stomach upset.
--Coromega--a paste form of fish oil available at health food stores or through http://www.coromega.com. Coromega tastes fruity and comes in little squeeze envelopes.
--Frutol--Pharmax, a British company, makes another fruity fish oil that is non-oily and tastes like apricot. It's actually fairly reasonably priced, too. However, it is hard to find. The only way I know to get is to go online at www.pharmaxllc.com. You may have to actually order through a health care provider.

When using any preparation of fish oil, the best way to determine your dose is to add up the EPA and DHA content. For instance, if you use a fish oil liquid that contains 320 mg EPA and 240 mg DHA per teaspoon, you will need two teaspoons a day to achieve the equivalent of our starting dose of 1200 mg of EPA+DHA, usually provided by 4000 mg total in 4 capsules. Note that some lipid and lipoprotein disorders will require higher doses, e.g., 1800 mg EPA+DHA for high triglycerides (>200 mg/dl) or high IDL.

Sudden death in athletes

A recent report in the Journal of the American Medical Association details how a group in the Veneto region of Italy cut back on the incidence of sudden cardiac death in athletes by a simple screening program.



You can read the abstract of the article at http://jama.ama-assn.org/cgi/content/full/296/13/1593.

Although sudden death in athletes is still a rare event, it is especially tragic when it happens. In this population, the incidence was 3.6 deaths per 100,000 athletes aged 12 to 35 years. By implementing a simple screening program that involved only a physical examination and an EKG, an astounding 89% reduction in sudden death was documented.

What lessons does this hold for those of us interested in coronary plaque reversal? Beyond the obvious lesson of pointing out the great benefit of simple screening of athletes, I believe that it tells us the value of simple screening tools for heart disease in general. It is my strong belief that, if we were to implement CT heart scans among the broad population of men 40 years and over, women 50 years and over--without regard to cholesterol or other relatively lame risk identifiers--we could slash the risk for heart attack and death 90% or more. Putting CT heart scans into the hands of the public makes your coronary risk obvious. It takes the guesswork out of risk predictors like cholesterol and high blood pressure.

But heart scans are already available, you say! Yes, of course they are. But the lack of insurance reimbursement continues to be a restricting factor for many people, despite the number of lives that could be potentially saved and the money that would be saved in the long run by reducing need for major heart procedures. The continuing resistance to prevention by my cardiology colleagues and the persistent ignorance of primary care physicians also remain major impediments.

But it's getting better. You don't have to be chained by ignorance. Put your CT heart scan to good use.

My heart scan was wrong!



Tom came into the office ready for a confrontation.

Tom's wife insisted that he see me to discuss the implications of his CT heart scan score of 459. At age 50, this was clearly bad news that placed Tom in the 99th percentile (worst 1% of men in his age group).

But Tom had already undergone a stress test. There had apparently been a small abnormality, and a heart catheterization had been performed by another cardiologist. "They told me they didn't need to do anything. No stent, no ballon, no bypass, nothing!"

I asked, "Did they tell you that there was any plaque or blockages seen?"

"Yeah, but he said it was nothing. So the heart scan was wrong!"

I've been here many times before. I explained to Tom that, no, his heart scan was not wrong. All the tests he'd undergone siimply provided a different perspective on the same disease. You could say:

--The stress test, being a test of blood flow, may have been abnormal because of the abnormal constrictive behavior of arteries containing plaque, known as "endothelial dysfunction", because the inner lining of arteries (the endothelium) control the tone of the artery. Abnormal constriction in arteries with plaque is quite common.

--The catheterization simply showed that no plaque had collected in a configuration to block flow, thus no stent, etc., since flow was normal. But there was indeed plaque.

All three tests were right; none were wrong. They all provided a little different perspective on the same process. Of course, I favor the heart scan as the means to identify, precisely measure, and track the atherosclerotic plaque in your arteries. The stress test is too crude and only measures flow, the catheterization is not something you'd want to undergo year after year. Catheterization also is too crude a measure to precisely track plaque growth or reversal.

So I explained to Tom that, even though a stent or similar procedure was unnecessary, he remained at substantial risk for heart attack due to plaque "rupture". In fact, Tom's heart attack risk was 5% per year, or approximately 50% over the next decade. That is, indeed, substantial. In fact, you might say that, of the three tests Tom underwent, only the heart scan revealed his true risk.
All posts by william-davis

Niacin scams

In the Track Your Plaque program, we often resort to niacin (vitamin B3 or nicotinic acid) to:

--Raise HDL cholesterol
--Reduce the proportion of small LDL particles
--Shift HDL towards the healthy larger fraction (HDL2b or "large")
--Reduce lipoprotein(a), the most aggressive risk factor known


But niacin comes with a crazy "hot flush," a warm, prickly feeling that usually envelops the upper chest, neck and face that is, without a doubt, annoying. Around 1 in 20 people simply cannot tolerate any amount of niacin >100 mg, while others have no problem even into the 3000 mg per day or more range. (Tolerance to niacin is genetically determined, governed by the rapidity of metabolism to the niacin metabolite, nicotinuric acid.)

The niacin flush has spawned an entire panel of niacin-like scams, agents that sound like niacin or may even contain niacin, but exert no beneficial effect whatsoever:

Flush-free niacin--I have previously posted on this useless but ubiquitous preparation that often costs several times more than conventional niacin. Flush-free niacin, or inositol hexaniacinate, does indeed contain niacin, but it is not released in the human body. You simply pass it out down the toilet, where this preparation belongs in the first place.

Nicotinamide--Also called niacinamide. While the nicotinamide/niacinamide forms of vitamin B3 can be used to treat B3 deficiency ("pellagra"), they do not reproduce the lipid and lipoprotein effects of niacin. For our purposes, they are useless.

Niacin-containing heart-healthy supplements--These are the multi-supplements that contain a little of everything that might be beneficial for the heart, but none at a dose that provides genuine benefit. Don't throw your money away.


There's also a prescription niacin, Niaspan, that costs 20-fold more than the best over-the-counter preparation, Sloniacin. Niaspan has yielded hundreds of millions of dollars for the pharmaceutical industry. Your money, in my view, is far better spent on Sloniacin (around $12-14 per bottle of 100 tablets of 500 mg).

For more on niacin, here's an article I wrote for the Life Extension Magazine people a while back: Using Niacin to Improve Cardiovascular Health.

Deja vu all over again?

HeartHawk brought a report and debate on The Heart.Org website to my attention:

Screening for risk factors or detecting disease? Debate divides the CV community. After landing on theheart.org, paste this onto your URL address:article/883239.do. (Full address: http://www.theheart.org/article/883239.do. I don't know why, but I couldn't go there directly.)

Some interesting comments:

Dr. Jay Cohn (University of Minnesota):

"They're saying that we can't identify disease very effectively so let's just stick with risk factors, which we know are very poorly predictive and nonspecific. It boggles my mind as to why they won't open up their minds to the importance of moving forward in finding better strategies to identify the disease that we are treating. It's very strange. They criticize these disease markers because they are not predictive of events, but they are looking at very short-term outcomes. We're interested in lifetime risk. We're screening people in their 40s who are concerned about morbid events in their 60s and 70s, and no trials are going to track them that long."

"You have to accept the pathophysiologic reality that heart attacks don't occur in the absence of coronary disease, and coronary disease doesn't occur in the absence of endothelial dysfunction and vascular disease, all of which now can be identified."

". . . Can we as a society and as a profession accept the idea that there is a link between the vascular abnormalities and the events? "And that that linkage is tight enough that it should allow us to accept slowing of progression of the vascular abnormalities as an adequate marker for slowing disease progression, without waiting for events to occur? As soon as you use the word surrogate, people jump up and say we have all these markers that we know don't work well—things like premature ventricular contractions [PVCs] on the electrocardiogram, LDL, HDL—but those are not the markers we're talking about. We're talking about structural and functional changes in the blood vessel and in the heart."



Wow. The idea may be starting to catch on.

As an interesting aside, Cohn et al use a 10-test panel to screen for vascular disease:

"Named for the center's benefactor, the Rasmussen score includes tests for large and small artery elasticity (compliance), resting blood pressure, blood-pressure response to moderate treadmill exercise, optic fundus photography, carotid intimal-media thickness (IMT), microalbuminuria, electrocardiography, left ventricular (LV) ultrasonography for LV volume and mass, and brain natriuretic peptide (BNP). Each test result is scored out of 10 for low, intermediate, or high risk, and the combined results yields a score that Cohn et al believe is more predictive than any of the existing standalone tests."


The counterarguments in this debate were provided by Dr. Philip Greenland (Northwestern University), who repeated his oft-used argument that, while he accepts that vascular disease can be identified, no one has proven that measuring it improves outcomes:

"We do have that evidence for risk-factor screening. Even though people criticize risk-factor assessment because it is not sensitive enough or not accurate enough, the interesting and curious thing is that we actually have evidence that if you go to the trouble of screening for risk factors and treating them, patients have better outcomes. We do not have that evidence for any of these other tests."


An interesting debate ensues that includes Track Your Plaque friend, Dr. William Blanchet, who characteristically argues persuasively in favor of broad screening for coronary disease with coronary calcium scoring:

"If we were doing our jobs in primary prevention, we would not need to look at improved intervention and secondary prevention to reduce coronary death."


Here's a shock: Dr. Melissa Shirley-Walton, the cardiologist who previously preached the "cath lab on every corner" argument seems to have undergone a change of heart:

"What if I walked up to a gentleman and said, "you are at risk for CAD, take a statin", to which he replies, "I'm afraid of those meds". BUT if he sees his calcium score........he is then convinced to be pro-active. What is so wrong with that? What is so wrong with allowing him to spend 250.00 US out of pocket in order to save the US 150,000.00 US later on?

No hard endpoints you say with intensive therapy for primary prevention? What about extrapolating from trials for secondary prevention like HATS? ARBITER2? And what exactly is the true definition of secondary prevention? Is it truly primary prevention if we already have intima thickness abnormalities, or fatty streaks? That would more likely fall under secondary prevention by today's new standards.

So, I'm all for any visual aid that will encourage compliance with life style change, necessary medical therapy and followup. If the patient is willing to spend 250.00$ to get a calcium score, so be it. Better yet, why not lower the price so everyone can have the option if they are motivated enough to seize an opportunity?"



I have to admit that I thought that Dr. Blanchet was wasting his time trying to persuade Shirley-Walton et al, but perhaps he is having an impact, though having hammered away at them for the last year or so.

These arguments, for me, eerily echo many previous debates I've heard. But I am encouraged by the more favorable treatment the notion of atherosclerosis screening is receiving. Just 5 years ago, all coronary calcium scoring would have received from the conventionalists is "more clinical studies are needed."

So perhaps the cardiology and medical worlds are inching slowly towards broad acceptance of screening for coronary and vascular disease.

BUT, screening is not sufficient. What do you do with the information?

Here is where the conventional-thinkers stop. The question that seems to occupy them: Perhaps we should screen people for hidden coronary and vascular atherosclerosis so we can better decide who needs a statin drug or a procedure.

I would pose a different challenge: We should screen people for hidden coronary and vascular atherosclerosis so we can better decide who needs to engage in an intensive program of disease reversal using natural means and as little medication and procedures as possible.

Well, perhaps in time.

Lead to Gold: The alchemy of transforming nutritional-supplement-to-medication

Here's a recipe to make hundreds of millions of dollars. Others have done it and you can do it, too!

1) Identify a nutritional supplement that works.

Find some agent deemed to fall within the broad allowances of the 1994 Dietary Supplement Health and Education Act . However, because this agent is already in the public domain and is essential non-patent-protectable, you may need to develop some patent protectable aspect of its production, application, or encapsulation. This patent-protected aspect may or may not provide genuine advantage, but that's not your concern. Your concern is protecting your investment and providing the appearance of exclusivity.


2) Identify a medical indication for your product.

Choose a disease or condition that is likely to yield unquestioned efficacy, e.g., omega-3 fatty acids to reduce high triglycerides in people with familial hypertriglyceridemia (triglycerides >500 mg/dl). While this will restrict your ability to make market claims, it will not restrain your ability to sell or allow use of your agent for "off-label" applications. In fact, there are methods to surreptitiously promote the use of your product for off-label use, such as hiring experts to discuss the science behind your product with doctors who can prescribe your product. Ideally, your product's primary indication will provide a substantial market on its own to justify your investment. However, the eventual off-label sales can be substantial, even outstripping the sales generated through your primary indication.


3) Obtain at least $230 million to pay for the clinical trials required to obtain FDA approval.

You will also have to raise the capital to build the business to manufacture, distribute, and sell your product.


4) After FDA approval is obtained, your business is up and running, and distribution begins, start bashing the non-FDA-approved nutritional products that stand to compete in your market.

You could point out that only your product has actually passed through the rigorous FDA process. You could make claims regarding purity, potency, "approved by your doctor," etc., whether or not there is any truth behind the claim.


5) Buy that second vacation home in Aspen and the corporate jet you've been dreaming about! After all the risks you've taken, you deserve it!


That's it, plain and simple. It is a tried-and-true formula that has been applied many times.

It is a formula like this that brought Lovaza-brand omega-3 fatty acids to market, Niaspan brand of niacin, ergocalciferol form of vitamin D, Folbee (prescription combination B vitamins), with a slightly different spin for Synthroid (since the Armour Thyroid it is meant to replace is not a nutritional supplement, but a low-cost, generic thyroid replacement).

Whatever you do, don't EVER run a head-to-head comparative trial of your agent versus the nutritional supplement competition. For instance, NEVER compare Lovaza to supplemental fish oil capsules, matched milligram-for-milligram for EPA and DHA content. NEVER compare Niaspan to over-the-counter Sloniacin. NEVER compare Armour Thyroid to Synthroid. You never know what you might find. (Psssssttt! They might be equivalent!)

The formula is not a foolproof road paved with riches, however. There have been market failures, as well. Folbee, for instance, is hardly a household name. So there's risk involved, no question about it. But, should it all work out, the payoff can be big, VERY big, as it has been for Niaspan and Lovaza.

So, start thinking about how you might follow this formula for:

1) Cholecalciferol (vitamin D3)--e.g., for osteopenia, low HDL, or high c-reactive protein
2) Vitamin K2--also for osteopenia
3) Magnesium--for suppression of ventricular arrhythmias (especially Torsade de Pointes)
4) Iodine--for goiter and iodine deficiency
5) Vitamin C--for uric acid reduction

Who said you can't turn lead into gold?

Another interview with Livin' La Vida Low Carb's Jimmy Moore

I recently provided another interview for Livin' La Vida Low Carb's Jimmy Moore.

You may remember Jimmy as the irrepressible host of the Livin' La Vida Low Carb Show who lost around 200 lbs, dropping from 410 to 230 lbs on a low-carbohydrate diet.

In this hour-long interview, we discussed some of the dietary strategies that we use in the Track Your Plaque program.

Jimmy's website is definitely worth exploring. It's loaded with great interviews, including with Good Calories, Bad Calories author, Gary Taubes.

"Millions of needless deaths"

"Millions of needless deaths" is the title of an editorial by Life Extension Magazine's Bill Faloon.

". . . If vitamin D’s only benefit was to reduce coronary heart attack rates by 142%, the net savings (after deducting the cost of the vitamin D) if every American supplemented properly would be around $84 billion each year. That’s enough to put a major dent in the health care cost crisis that is forecast to bankrupt Medicare and many private insurance plans."

Although I don't agree with all the over-the-top commentary that issues from Mr. Faloon or Life Extension (although I sit on their Medical Advisory Board), I agree with virtually all of the issues he raises with vitamin D.

Despite the enormously compelling observations of vitamin D potential effects in populations, the medical community's reluctance comes from the lack of treatment data. In other words, what we lack are long-term data on vitamin D supplementation vs. placebo on rate of heart attack, vitamin D vs. placebo on risk of colon cancer, etc.

The data that exists connecting vitamin D levels with cardiovascular risk originate from three population observations:

1) The NHANES data in 16,000 participants showed 20% increased risk of cardiovascular events in those with vitamin D levels <20>20 ng/ml after factoring in all standard risk factors.

Another NHANES analysis showed the high prevalence of vitamin D deficiency in those with cardiovascular disease.

2) A German study of 2500 participants that showed showed the lowest quartile of vitamin D levels (<13.3>28.4 ng/ml.

3) The Health Professionals' Follow-Up Study of 18,000 males showed a 2.4-fold increase in cardiovascular events in those with vitamin D levels <15>30 ng/ml.

While we lack treatment data (vitamin D vs. placebo) in a large population, we do have data that Suzie Rockway, Mary Kwasny (both from Rush University, Chicago) and I generated on the effect of vitamin D as a part of a broader treatment program on coronary calcium scores:

Effect of a Combined Therapeutic Approach of Intensive Lipid Management, Omega-3 Fatty Acid Supplementation, and Increased Serum 25 (OH) Vitamin D on Coronary Calcium Scores in Asymptomatic Adults.
Davis W, Rockway S, Kwasny M. Amer J Ther 2008 (Dec 15).

The impact of intensive lipid management, omega-3 fatty acid, and vitamin D3 supplementation on atherosclerotic plaque was assessed through serial computed tomography coronary calcium scoring (CCS). Low-density lipoprotein cholesterol reduction with statin therapy has not been shown to reduce or slow progression of serial CCS in several recent studies, casting doubt on the usefulness of this approach for tracking atherosclerotic progression. In an open-label study, 45 male and female subjects with CCS of >/= 50 without symptoms of heart disease were treated with statin therapy, niacin, and omega-3 fatty acid supplementation to achieve low-density lipoprotein cholesterol and triglycerides /=60 mg/dL; and vitamin D3 supplementation to achieve serum levels of >/=50 ng/mL 25(OH) vitamin D, in addition to diet advice. Lipid profiles of subjects were significantly changed as follows: total cholesterol -24%, low-density lipoprotein -41%; triglycerides -42%, high-density lipoprotein +19%, and mean serum 25(OH) vitamin D levels +83%. After a mean of 18 months, 20 subjects experienced decrease in CCS with mean change of -14.5% (range 0% to -64%); 22 subjects experienced no change or slow annual rate of CCS increase of +12% (range 1%-29%). Only 3 subjects experienced annual CCS progression exceeding 29% (44%-71%). Despite wide variation in response, substantial reduction of CCS was achieved in 44% of subjects and slowed plaque growth in 49% of the subjects applying a broad treatment program.


I also summed up the data as of early 2008 in a Life Extension article:

Vitamin D's Crucial Role in Cardiovascular Protection


I do agree with Mr. Faloon: It's time to take the vitamin D issue very seriously. Personally, I think it is foolhardy to not correct vitamin D deficiency, even in the absence of long-term treatment data.

Should we subject people living in tropical climates with vitamin D blood levels of 90 ng/ml to long-term observation? Though that has not yet been done, it has been done--in effect--through observations on the prevalence of diabetes, heart disease, and various cancers by latitude: the farther away from the equator, the greater the prevalence of these diseases.

That's more than good enough for me.

Thiazide diuretics: Treatment of choice for high blood pressure?

Thiazide diuretics are a popular first-line treatment for hypertension among the primary care set.

This practice became especially well-established with the 2002 publication of the ALLHAT Study (Major Outcomes in High-Risk Hypertensive Patients Randomized to Angiotensin-Converting Enzyme Inhibitor or Calcium Channel Blocker vs Diuretic:The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)).

ALLHAT showed that an inexpensive diuretic like chlorthalidone (a weak diuretic in the thiazide class, similar to hydrochlorothiazide) as first-line treatment for hypertension achieved equivalent reductions in cardiovascular events (cardiovasular death and heart attack) as non-thiazide antihypertensives, lisinopril (an ACE inhibitor) and amlodipine (a calcium channel blocker, better known as Norvasc).

After 7 years of treatment, there was 14% death or heart attack among all three groups--no difference.

This was interpreted to mean that inexpensive thiazide diuretics like chlorthalidone offer as much benefit as other blood pressure medications at reduced cost.

On the surface, that's great. Anything that detracts from the ubiquitous pharmaceutical industry propaganda of bigger, better, more expensive drugs to replace old, inexpensive, generic drugs is fine by me.

But you knew there'd be more to this issue! If we accept that thiazides are equivalent to other single-drug treatments for high blood pressure, what do we do with the following issues:

--Thiazides deplete body potassium-This effect can be profound. In fact, built into the ALLHAT mortality rate is an expected death rate from potassium depletion. When potassium in the body and blood go low, the heart becomes electrically unstable and dangerous rhythms develop.

--Thiazides deplete magnesium--Similar in implication to the potassium loss, magnesium loss also creates electrical instability in the heart, not to mention exaggeration of insulin resistance, rise in triglycerides, reduction in HDL.

--Thiazides reduce HDL cholesterol

--Thiazides increase triglycerides

--Thiazides increase small LDL particles--You know, the number one cause for heart disease in the U.S.

--Thiazides increase uric acid--Uric acid is increasingly looking like a coronary risk factor: The higher the uric acid blood level, the greater the risk for heart attack. Thiazides have long been known to increase uric acid, occasionally sufficient to trigger attacks of gout (uric acid crystals that precipitate in joints, like rock candy). (Fully detailed Special Report on uric acid coming this week on the Track Your Plaque website.)

What about the advice we commonly give people to hydrate themselves generously? Yet we give them diuretics? Which is it: More hydration or less hydration? You can't have both.

Do thiazides exert an apparent cardiovascular risk reduction in a society due to its flagrant sodium obsession?

Thus, there are a number of inconsistencies in the thinking surrounding thiazides. In my experience, I have seen more harm done than good using these agents. While I cannot fully reconcile the reported benefit seen in ALLHAT with what I see in real life, all too often I see people having to take another drug to make up for a side-effect of a thiazide diuretic (e.g., high-dose prescription potassium to replace lost potassium, allopurinol to reduce uric acid, etc.). I have seen many people get hospitalized, even suffer near-fatal or fatal events from extremely low potassium or magnesium levels.

My personal view: ALLHAT or no, avoid thiazide diuretics like the plague. Sure, it might save money on a population basis, but I suspect that the ALLHAT data are deeply misleading.

What's better than a thiazide, calcium blocker, or ACE inhibitor? How about vitamin D restoration, thyroid normalization, wheat elimination?

"High-dose" Vitamin D

I stumbled on one of the growing number of local media stories on the power of vitamin D.

In one story, a purported "expert" was talking about the benefits of "high-dose" vitamin D, meaning up to 1000, even 2000 units per day.

I regard this as high-dose---for an infant.

Judging by my experiences, now numbering well over 1000 patients over three years time, I'd regard this dose range not as "high dose," nor moderate dose, perhaps not even low dose. I'd regard it as barely adequate.

Though needs vary widely, the majority of men require 6000 units per day, women 5000 units per day. Only then do most men and women achieve what I'd define as desirable: 60-70 ng/ml 25-hydroxy vitamin D blood level.

I base this target level by extrapolating from several simple observations:

--In epidemiologic studies, a blood level of 52 ng/ml seems to be an eerily consistent value: >52 ng/ml and cancer of the colon, breast, and prostate become far less common; <52 ng/ml and cancers are far more likely. I don't know about you, but I'd like to have a little larger margin of safety than just achieving 52.1 ng/ml.

--Young people (not older people >40 years old, who have lost most of the capacity to activate vitamin D in the skin) who obtain several days to weeks of tropical sun typically have 25-hydroxy vitamin D blood levels of 80-100 ng/ml without adverse effect.

More recently, having achieved this target blood level in many people, I can tell you confidently that achieving this blood level of vitamin D achieves:

--Virtual elimination of "winter blues" and seasonal affective disorder in the great majority
--Dramatic increases in HDL cholesterol (though full effect can require a year to develop)
--Reduction in triglycerides
--Modest reduction in blood pressure
--Dramatic reduction in c-reactive protein (far greater than achieved with Crestor, JUPITER trial or no)
--Increased bone density (improved osteoporosis/osteopenia)
--Halting or reversal of aortic valve disease

(I don't see enough cancer in my cardiology practice to gauge whether or not there has been an impact on cancer incidence.)

My colleagues who have bothered to participate in the vitamin D conversation have issued warnings about not going "overboard" with vitamin D, generally meaning a level of >30 ng/ml.

I know of no rational basis for these cautions. If hypercalcemia (increased blood calcium) is the concern, then calcium levels can be monitored. I can reassure them that calcium levels virtually never go up in people (without rare diseases like sarcoid or hyperparathyroidism). Then why any hesitation in recreating blood levels that are enjoyed by tropical inhabitants exposed to plentiful sun that achieve these extraordinary health effects?

For the present, I have applied the target level of 60-70 ng/ml without apparent ill-effect. In fact, I have witnessed nothing but hugely positive effects.

Vitamin D Home Test

The ever-resourceful Dr. John Cannell of the Vitamin D Council has announced the availability of an at-home, self-ordered vitamin D test kit for $65. The Vitamin D Council newsletter is reprinted below.

(However, please note that, as wonderful as the advice Dr. Cannell provides, I don't agree on several small points, such as the lack of need for vitamin D if you use a tanning bed or obtain "sufficient" sun; I have seen many people with dark tans, virtually all over 40 years old, who are still severely deficient. I attribute this to the lost capacity for vitamin D activation as we age.)

I have not used this service. Should anyone choose to try it, please let us know how it goes.



The Vitamin D Newsletter
December 28, 2008

The Vitamin D Council is happy to announce that we have partnered with ZRT Laboratory to provide an inexpensive, $65.00, in-home, accurate, vitamin D [25(OH)D] test. The usual cost for this test is between $100.00 and $200.00.

If you read this newsletter, you know about our interest in accurate vitamin D testing. In the next few weeks, you may read about the Vitamin D Council's quest for accurate vitamin D blood tests in the national media. Before we partnered with ZRT, we verified, repeatedly, that ZRT provides accurate and reliable vitamin D tests and that their method corresponds very well to the gold standard of vitamin D blood tests, the DiaSorin RIA.

Our ZRT service is not just inexpensive, it means no more worrying about your doctor ordering the right test or interpreting it correctly. You buy the test kit on the internet or by phone, a few days later the kit comes in the mail, you or a nurse friend do a finger stick, collect a few drops of blood, and send the blotter paper back to ZRT in the postage paid envelope provided with the kit. A week later you get results back in the mail and know accurate 25-hydroxy-vitamin D levels of you and your family.

For every test you order, ZRT will donate $10.00 to the Vitamin D Council. Please read the new page hyperlinked below on our website as it both explains the procedure and how to order the test.

http://www.vitamindcouncil.org/health/deficiency/am-i-vitamin-d-deficient.shtml

Executive summary: keep your family's 25-hydroxy-vitamin D blood test above 50 ng/ml, year around. Most adults need at least 5,000 IU per day, especially this time of year. Most children need at least 1,000 IU per day per every 25 pounds of body weight. Bio Tech Pharmacal provides high quality and inexpensive vitamin D. Currently Bio Tech Pharmacal is providing vitamin D for numerous scientific studies. To see their prices and for ordering, click the hyperlink below.

http://www.bio-tech-pharm.com/catalog.aspx?cat_id=2

As a gift to our readers for the New Year, Thorne publications have provided a free download to a basic paper about vitamin D. I wrote it earlier this year for educated lay people as well as health care practitioners. Please read this paper carefully, your family's well-being, even lives, may depend on you understanding it.

http://www.thorne.com/altmedrev/.fulltext/13/1/6.pdf

Seasons Greetings
John Cannell, MD
vitamindcouncil.org

Where do Track Your Plaque membership revenues go?

People pay about $90 per year to become Members on the Track Your Plaque website. This provide access to our in-depth Special Reports, guides, webinars, and our proprietary software data tracking tools. Members can also participate in online discussions, such as those in the Track Your Plaque Forum and chats.

Why is there a charge for membership in the program and where does the money go?

Money raised from membership fees goes towards:

1) The costs of doing business, e.g., server fees, software purchases, legal fees. Hosting webinars, for instance, costs us about $99 per month for the GoToWebinar software service.

2) Software development--Our most recent round of software data tracking tools, for instance, cost us nearly $30,000. That may not be a lot from big business standards, but it is onerous enough that obtaining membership dues really helps.

3) Graphics development--A website without graphics would be awfully dull, regardless of the quality of the textual content. Some of the newest tools on the Track Your Plaque website require photography and graphics work, which can add up very quickly.


Where membership fees do NOT go:

1) In our pockets--In fact, except for the various contractors who are paid for their services (e.g., software developers), NOBODY on the Track Your Plaque staff are paid: not me, nor any of the behind-the-scenes staff. Some of the staff overlap with my office staff, but they are paid purely out of the office revenues, not out of Track Your Plaque membership dues.

2) Towards overhead costs beyond those listed above--For example, membership fees do not pay for office lease, utilities, phones, etc.


We rely on membership fees because we have chosen to remain as free of commercial bias as possible. We host no advertising, we have no behind-the-scenes corporate or institutional agendas, we show no favoritism to any business or commercial operation. We believe this permits editorial freedom that few other health websites can enjoy. (In fact, I know of no other that is so free of commercial bias, outside of small blogs or narrow-interest websites.)

If you want to see what damage commercial bias can create, just go to a health website like WebMD. I challenge you to find information that is not flagrantly biased by commercial influence, namely that of the drug industry. (According to the WebMD SEC filings, in fact, the great majority--approximately 80%--of their $331 million revenues (2007) were derived directly or indirectly from the drug industry.) This commercial bias reaches into all of WebMD's related businesses, including MedicineNet.com, RxList.com, Medscape.com, and several others.

Preventing heart disease is not a money maker, sad to say. It is, from the perspective of conventional heart care, a big money loser. Undergo a heart catheterization, hospitalization, stent or bypass for anywhere from $14,000 to well over $100,000---or pay $90 for in-depth health information that dramatically reduces the potential need for the hospital and its procedures, minimizes need for prescription medication (statins alone, of course, are a $27 billion annual revenue phenomenon), and achieves all this by maximizing nutrition, self-purchased nutritional supplements, and inexpensive heart scans. Nobody is going to make a bundle off of this approach.

So that is why we charge a membership fee. I often get a laugh from some of the comments of people on this blog or even in my office who believe that we are rolling in money from the website from membership dues. The opposite is true: We don't pay ourselves. Virtually every penny is reinvested back into the website to better serve the Members.