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.
All posts by william-davis

Heart disease reversal is getting easier and easier

I've recently observed that more and more of our patients on the Track Your Plaque program seem to be stopping or reducing their heart scan scores. And they're doing it faster, in less time, and with larger drops in score.

I'm not entirely sure why the sudden surge in success. However, I do wonder if adding therapeutic levels of vitamin D--at least in our generally sun-deprived Wisconsin participants--is responsible. However, we've also gotten a lot smarter on how to correct the parameters that seems to have outsized effects on plaque growth, especially small LDL.

Yesterday alone, we had two people we added to our list of successes. One, an attorney, stopped his score in one year, with no change (compared to the expected increase of 30%). Another, a woman from the northeast, dropped her score 10% in one year. Her story is remarkable for beginning at a score >1000. In general, the higher your starting score, the longer it takes to stop or reduce it.

These are just two examples. It seems to be happening at an accelerating pace.

I can only hope that our surge in success (not 100%--yet!) will continue. But, every week, we're adding more and more people to our list of success stories.

A used car lot on every street corner

Imagine that, every day, a parade of used-car salesmen knock on your front door to sell you a special "deal". Day in, day out they knock, expecting you to hear about their offers openly.

Is there any doubt about their intentions or motives? Of course not. They're just trying to profit from selling you a car.

That's how it is in a medical office nowadays. Drug representatives, 5, 6, or more each and every day, promoting drugs. Except that the profits from drugs are far greater than a used automobile, and there's a third party involved in the transaction: you.

Today, a pushy representative came to my office. My staff and I tried to tell him that I was not interested in speaking to him. But he proved such a nuisance that I finally came out to tell him that I objected to the idea of drug reps just hanging around trying to hawk their wares.

He blurted, "Doctor, do you have patients with angina? Our new drug, ranolazine, is perfect. Forget about nitroglycerin, beta blockers, and all that. Here's the latest study proving it's better." He tried to shove a reprint of the study at me.

Getting to the bottom line, I asked, "What does it cost the patient?"

"Well, the co-pay is between $40 and $60. We're not yet well covered by insurance, so it'll cost patients around $200 a month."

Need I say more? Here's a drug that does little more than help relieve anginal chest pains. It doesn't reverse coronary plaque. It won't avoid heart attack, death, or procedures. It just modestly cuts back on the frequency of chest pain. And all for the cost of a single heart scan--a heart scan that could have prevented the entire cascade of symptoms/procedures/medication/hospitalization etc.

Hospitals, drug companies, medical device manufacturers. They're all businesses that thrive on your doctor's failure to detect and control your coronary plaque. Sometimes, even your doctor is part of this conspiracy to squeeze dollars out of human disease. Don't fall for it.

Heart disease reversal at age 77

I met Agnes 18 months ago after she underwent a heart scan that revealed a scary score of over 1100. Although in her mid-70s, this was still a very high score. (Recall that a score this high carries a risk for heart attack and death of 25% per year.) Poor Agnes was a wreck over this unexpected result. "I can't sleep, I can't stop thinking about it!"

She'd undergone the scan because her 44-year old son had a heart scan score of 2200! Unfortunately, he ended up with a bypass operation for very severe disease.

Despite having been seeing a cardiologist in Boston for the last 8 years for a murmur, we uncovered multiple hidden lipoprotein patterns, many of which she shared with her son. Her most notable abnormalities were a low HDL and small LDL. Nearly 100% of all LDL particles were, in fact, small. This pattern also caused her LDL cholesterol to be underestimated by over 40%.

18 months on the Track Your Plaque program and Agnes came into town to get a repeat scan. Her score was 10.2% lower. She'd learned to live with the idea that she had hidden heart disease missed by her doctor and cardiologist for many years. But knowledge of the substantial reversal she'd achieved in the 18 months on the program gave Agnes tremendous peace of mind.

Agnes left the office with a big smile.

If you need a reason to quit smoking...

If you've read Track Your Plaque, you already know my feelings about smoking and coronary plaque. Smoke, and you will lose the battle for control over coronary plaque growth--it will grow and grow until catastrophe strikes.

Nonetheless, this is not sufficiently motivating for some people.

If you need more motivation to quit smoking, just take a look at your heart scan sometime, accompanied by either one of the doctors or technicians at the scan center you choose. After you've had an opportunity to look at your coronary arteries, take a look at the lungs. The heart is in the middle and the lungs are the two large black areas on either side of the heart. (They're not really black; that's just the way the images are color-coded.)

Smokers will see large cavities in their lungs--literally, half-inch to one-inch wide holes that contain only air. Many of them. These represent remnants of lung tissue, digested away and now useless from the damage incurred through smoking.

Non-smokers should see uniform lung tissue without such cavities.

What surprised me early on in my heart scan experience was how little smoking exposure was required to generate these cavities. A 40-year old, for instance, who smoked a half-pack per day for 10 years would have them. Heavier smokers, of course, showed far more extensive cavities.

Officially, these cavities are called "emphysematous blebs", meaning the scars of the lung disease, emphysema.

When I've pointed out these cavities or emphysematous blebs to patients, 9 out of 10 times they immediately become non-smokers. Commonly, they'd exclaim, "I had no idea I was really damaging my lungs!" Most admitted that they were awaiting some bona fide evidence that they were truly doing some harm to their bodies. Well, that's it.

Give it a try if you're struggling.

Vitamin D for winter blues?

Winter is now over and spring is in the air, even in Wisconsin.

In this part of the country, winter blues are commonplace. Sometimes called Seasonal Affective Disorder (SAD) when it's severe enough to cause functional impairment, feelings of fatigue, lack of motivation, or the blues are very frequent when days are short and sunlight is in short supply.

I've been seeing many people in the last several weeks who were advised to add vitamin D to their program last fall. Christopher's experience was typical.

"You know, since you told me to take vitamin D, I didn't get sad and tired like I do every winter. This is the first time I can remember that happening. I didn't sleep as much and I didn't get that feeling of always being overwhelmed."

I've felt it myself this past winter. I think there's some real truth to this effect.

Dr. Bruce Hollis has published a small experience in treating people with SAD with vitamin D and showed measurable improvement in depression. (One recent study in older women failed to show any effect, however, when small doses of vitamin D of 800 units were administered. In my experience, this dose doesn't even come close to normalizing blood vitamin D levels.)

The best source for in-depth information on vitamin D is Dr. John Cannell's website, www.vitaminDcouncil.com. If you've read Dr. Cannell's discussion on the Track Your Plaque website, you know that he is an articulate spokesman for the benefits of vitamin D replacement. He also persuasively argues that vitamin D deficiency is rampant in northern climates and in people who don't get frequent sun exposure. Interestingly, we now have two studies of populations in Florida and one in Hawaii, both of which showed substantial percentages of people even in these tropical climates to be deficient in vitamin D (around 50% in Hawaii and 30% in Florida).

The dose we've used with much success is 2000 units per day in females, 3000 units per day in males. This yields normal blood levels of around 50 ng/dl in around 80-90% of people. Occasional people will require more, some less. The best way to do it is to check a baseline blood level and a level on therapy to determine the adequacy of your dose.

Dr. Cannell will tell you that it's very important to have your doctor check the right test: 25-OH-vitamin D3, not 1,25-diOH-vitamin D3. These are two very different tests of two different compounds.

In the Track Your Plaque program, we use vitamin D to reduce pre-diabetic tendencies, reduce blood pressure (vitamin D is an inhibitor of the pressure-raising hormone renin), shut down inflammation, and gain better control over coronary plaque (mechanism uncertain). In the process, you will sharply reduce risk of osteoporosis, colon and prostate cancer.

And maybe you'll be brighter when the winter blues come around again.

$4 per gallon gas is good for your health!

Gasoline is now approaching $4 per gallon in some parts of the U.S. But there's a silver lining in this dark cloud. In fact, I see this as a positive for your health.

How can higher gas prices possbily be good for health?

Imagine this trend continues: Fuel prices climb higher and higher. Driving your car will become increasingly more costly. What will be the fall-out?

Well, there will be a number of implications. But among the developments will be a broad impetus towards rejecting fuel-based sources of transportation. This may come as a shock to you, but humans legs were meant for walking!

Remember way back when, Mom would say "We need some milk"? In 1953, you wouldn't get in your car and zip to and from the supermarket. Instead, you would walk a quarter-mile, half-mile or more to the store. And you would carry your bags back. You might walk a mile or two to school and back. In 2006, this seems incomprehensible.

Higher fuel prices will prompt a gradual return to 1953--As transportation costs climb, your town may try and make it easier to walk as an alternative means of getting places.
Imagine that it was easy to walk three blocks to the grocery store, produce stand, work or school, walk along pleasant paths on the weekend, stroll to the home of friends. Drive or walk? Leave the car in the garage and save you and your family hundreds of dollars a month in gas bills.

In a few years, given the current fuel cost trends, there won't be a choice. But it will be in your favor for health.

Another Ornish casualty

Barry's lipoproteins were nearly all corrected to perfection: LDL 64 mg, HDL 57 mg, triglycerides 45 mg. He was approaching the Track Your Plaque goal of 60/60/60, the levels we find tip the scales heavily in your favor for achieving plaque reversal.

But one problem still prominently persisted: small LDL. Of Barry's 64 mg of total LSL, 90% of his LDL were small.

Barry was already on niacin (Slo-Niacin; Upsher Smith)1000 mg per day and fish oil, 4000 mg per day, both of which contribute to correction of this pattern. He had added occasional raw almonds and oat bran to his daily habits, both of which also help suppress small LDL. "I thought you told me that small LDL should go away if I did all this!" he lamented in frustration.

We probed Barry's diet choices more closely. "I eat really healthy foods, just like an Ornish program." Uh oh.

"What do you mean?" I asked.

"For breakfast, I have two slices of whole wheat toast--no butter or margarine, of course! I'll have Shredded Wheat with skim milk. That's it. My typical lunch is low-fat turkey--no mayonnaise!--on whole wheat. I'll add some low-fat whole wheat crackers or pretzels. That's pretty much my habit."

"How about dinner?"

"Dinner varies a lot. I'll usually have a low-fat meat like chicken or turkey, never beef, a vegetable, and a potato. I love rolls but I try to make them whole wheat. I don't use gravy. I love ice cream, so I've been having low-fat frozen yogurt instead. I guess that's about it."

Barry had indeed been counseled on how we approach nutrition. We, of course, do not endorse the low-fat approach of the Ornish program. Low saturated and hydrogenated fat, yes, but not the super-strict low-fat, "all fat is bad" approach of Dr. Dean Ornish.

Barry's diet is typical of someone on a low-fat restriction. When I asked him why he was eating this way, he admitted that he'd seen Dr. Ornish on a TV program in which he persuasively proclaimed that he reversed heart disease in his patients over the past nearly 20 years using this low-fat approach.

That explained it. Barry's nearly pure carbohydrate diet was triggering high blood sugar responses after meals, causing his insulin to skyrocket and magnifying the small LDL pattern.

I advised Barry to dramatically reduce his carbohydates like breads, pretzels, low-fat yogurt, crackers, etc. Instead, he could increase his lean proteins like eggs, egg whites, Egg Beaters, raw nuts and seeds, low-fat (yes, low-fat!) dairy products like yogurt and cottage cheese (both high protein), and healthy oils.

I've seen this happen with many people over the years: A severe low-fat restriction becomes a high-carbohydate diet. It's not uncommon for many people to have more than 70% of calories from carbohydrates on these programs.

The low-fat approach worked in the era of high-fat diets in the 1980s. In 2006, where convenience foods made with carbohydrates, especially wheat, predominate and pack 80% of supermarket shelves, low-fat is now a distorted nutritional mistake that leads to problems like Barry's uncontrolled small LDL, and often pre-diabetic or overt diabetes.

Should you take Plavix?

A question I get fairly frequently nowadays is, "Should I take Plavix?"

For the few of you who've managed to miss the mass advertising campaign for this drug on TV, USA Today, etc., Plavix is a platelet-blocking drug, known chemically as clopidogrel, that "thins" the blood and helps prevent blood clot formation in coronary arteries and carotid arteries, thus potentially reducing heart attack and stroke risk.

What if you have a heart scan score of, say, 450--should you take Plavix?

In general, no. First of all, aspirin and Plavix (generally taken together, since the effect of Plavix is incremental to that of aspirin) only block blood clot formation. They have no effect whatsoever on the rate of plaque growth. Aspirin and Plavix will neither slow it or increase it.

What they do is when a plaque ruptures like a little volcano and exposes its internal contents (inflammatory cells, fat, etc.--like a raw wound), a blood clot forms on top of the ruptured surface. If the clot is big enough, it can occlude the vessel and causes heart attack. Or, if it's a carotid artery, debris from the clot can break off and find its way headward to the artery controlling your speech or memory center. Aspirin and Plavix simply help inhibit clot formation once a plaque ruptures. That's it.

Interestingly, if you view any of Sanofi Aventis' commercials for Plavix, you'd think they came up with a cure for heart disease. It ain't true.

When is Plavix helpful? It's clearly an advantage after someone receives a coronary stent, drug-coated or uncoated;, after coronary bypass, particularly if certain metal punch devices are used to create the grafts in the aorta; and during and after heart attack. These are all situations in which blood clot formation is a forceful process. Blocking it helps.

In general, in asymptomatic people with positive heart scan scores at any level, we do not recommend taking Plavix. The Plavix people are extremely aggressive pushing their drug (hang around any medical office and see!) and, I believe, have gone overboard in promoting its benefits. Rarely, in someone with a very high heart scan score, say 2000 or more, we'll use Plavix for a period of a few months until lipids/lipoproteins and other risk measures are addressed, just as an added safety measure. But, in general, the great majority of people with some heart scan score or another do not receive it and I don't believe that they should.

As always, look beyond the marketing. The purpose of marketing is to increase profits, not to educate.

Dr. Ornish goofed

"I don't think I need the Track Your Plaque program. I've been doing the Ornish program, so I think that my plaque has already regressed."

So proclaimed Bruce, a recent patient I saw in consultation. Having suffered a heart attack three years earlier, he was thoroughly convinced that he was now cured following the Ornish program.


Indeed, back in the 1980s, many of us existed on greasy, high-fat diets of cheeseburgers, French fries, fried chicken, plenty of butter or margarine, mayonnaise, and the like.

Along came Dr. Dean Ornish, who wrote a book called "Dr. Dean Ornish's Program for Reversing Heart Disease: The Only System Scientifically Proven to Reverse Heart Disease Without Drugs or Surgery". This book struck a chord during this era and has been a hot-seller ever since it was published.

Does it work? In my experience, no, it does not.

Dr. Ornish claimed that sharply curtailing fat intake reverses heart disease. Closer to the truth is that, in people who start with high fat intakes, a low-fat restriction is indeed an improvement. This will lead to a modest improvement in blood flow in the coronary arteries due to a phenomenon called "endothelial dysfunction." This means that arteries will dilate modestly when specific changes are made. Thus, you will see minimal improvements in the measures he used (stress testing with nuclear imaging.)

What it does not mean is that plaque has regressed, certainly not "reversed".

In fact, our experience (over 10 years ago, when we first used the Ornish approach) was that the majaority of people did worse on this low-fat program: HDL dropped, triglycerides increased, blood sugar increased, inflammatory measures like C-reactive protein increased. Some people even magnified diabetic or pre-diabetic patterns.

It's almost certain that Bruce has not reversed his coronary plaque. In fact, I would bet that his plaque has grown substantially. Bruce started three years earlier from a diet high in unhealthy fats. If the expected rate of coronary plaque growth is 30% per year, perhaps he slowed it--to 20% or so. Since he didn't have a heart scan score at the time of his heart attack, we'll never know if he truly did reduce the quantity of coronary plaque he had.

But when I met him on his Ornish program, Bruce showed disturbing patterns that included an HDL cholesterol of 38 mg, 70% of all LDL particles were small, triglycerides measured 209 mg, and C-reactive protein was high at 2.8 mg/l. In other words, Bruce's plaque causes were far from corrected. Perhaps they were worse.

The Ornish program, despite it's ambitious claims, has outlived its usefulness. In 2006, it is an antiquated relic of a time past when lifestyle habits and technology were different.

Warning: This product may contain wheat!

Jerry experienced a peculiar sensation in his chest one evening while watching TV with his wife and kids. He squirmed in his chair and experienced a little breathelessness. But he kept it to himself and didn't say anything to his wife.

Fortunately, the feeling passed. But it concerned Jerry enough that he called a local heart scan center and scheduled a CT heart scan.* Minutes later, Jerry had a heart scan score of 112. At 46 years old, this placed him in the 90th percentile compared to other men in his age group.

Jerry came to my office for consultation. Among the first steps we took was to perform lipoprotein testing. Jerry showed striking abnormalities that included an HDL cholesterol of 38 mg, triglycerides of 210 mg, an unimpressive LDL of 133 mg but comprised of 99% small LDL, and excessive IDL (meaning that he was unable to clear dietary fats after eating).

At 5 feet 10 inches, Jerry weighed 190 lbs. He showed a slight excess bulge at the tummy, but hardly obese.

Jerry's history was remarkable, however, for the amount of carbohydrates he ate. "I'm addicted to bread. I love it! If I smell a loaf of fresh baked bread, I sometimes eat the whole loaf!"

Jerry also admitted to over-indulging in bagels (whole wheat), pretzels, low-fat snack chips, Raisin Bran cereal, Cheerios, and noodles. In fact, many days he'd have 5 or 6 servings of any of these foods. He also complained of an extraordinary amount of bowel gas and cramping. "Sometimes, I'm afraid to go to a group function. I might embarass myself."

I suggested an experiment: For a 4 week period, completely eliminate wheat-containing products--breads, pretzels, breakfast cereals, pasta, etc. In their place, increase intake of protein foods like eggs, raw almonds and walnuts, low-fat yogurt, cottage cheese, chicken, fish, and use healthy oils (olive, canola, grapeseed, flaxseed) more liberally.

Just four weeks later, Jerry came to the office a new man: 8 lbs lighter, brighter, with bursts of energy he hadn't had in years. And no gas!

Lesson: Wheat-based carbohydrates can be the culprit behind many lipoprotein patterns, especially low HDL, high triglycerides, small LDL, and others. Wheat can also be responsible for a myriad of abdominal symptoms, even joint pains and rashes. In its most extreme form, it's called "celiac disease". But experiences like Jerry's are quite common--not as obvious and dramatic as full-blown celliac disease, but smouldering and destructive, nonetheless.

Track Your Plaque expert, Dr. Loren Cordain of Colorado State University, tells us that, in his reconstruction of the history of human illness, there was an extraodinary surge in disease just about the time when humans began cultivating wheat around 8000 B.C. (Track Your Plaque members: Read Dr. Cordain's fascinating interview at http://www.cureality.com/library/fl_04-005cordaininterview.asp.)

Do you need to eliminate wheat products entirely from your diet? It's something to think about, particularly if you share any of the difficulties that Jerry had.


*In general, I do not recommend heart scanning as a self-prescribed tool for chest pain or other symptoms. Symptoms should always be discussed with your doctor.