Can natural treatments "cure" or "treat" any disease?

According to current FDA policy, the answer is a flat "NO!"

No natural treatment, whether it be fish oil (as a nutritional supplement), l-arginine, vitamin D, magnesium, various flavonoids like theaflavin or resveratrol, can be declared to treat or cure any disease. That's why you see the evasive and vague wording on nutritional supplements, nutraceuticals, and various foods, like "Supports heart health" or "Supports healthy cholesterol". Claiming, for instance, that taking 6000 mg per day of a standard OTC fish will reduce triglycerides and stating so on the label of a supplement is unlawful and prosecutable.

Think what you will of Mr. Kevin Trudeau (author of Natural Cures They Don't Want You to Know About"): visionary, consumer advocate, David vs. the Goliath of the FDA and "Big Pharma", or huckster, scam artist, and one-time felon. But Trudeau got it right on one important issue: The FDA dictates what claims can be made to treat disease. On one of his ubiquitous informercials, Trudeau states:


"...the way the system works today, you have the Food and Drug Administration—the FDA, and you have the drug industry. They really work in tandem. Unfortunately, there’s an unholy alliance there. People don’t know that the majority of commissioners of the FDA, which allegedly regulates the drug industry, and the food industry—Food and Drug Administration, the commissioners of the FDA—the majority of them—go to work directly for the drug companies upon leaving the FDA and are paid millions and millions and millions of dollars. Now in any other format, that would be called bribery; that would be called a conflict of interest; that would be called payoffs. That’s exactly what’s happening right now. So what has occurred is the Food and Drug Administration is really working in tandem with the drug industry to protect their profits. Example: The Food and Drug Administration says that only a drug can diagnose, prevent, or cure any disease."


He goes on to say that

"...the Food and Drug Administration says only a drug--nothing else--can cure, prevent, or diagnose a disease. Therefore the Food and Drug Administration continues to call more and more and more things diseases. Therefore they eliminate all-natural remedies. No one can say what a natural remedy can do if it’s been classified as a disease. So Attention Deficit Disorder is now a disease. Therefore only a drug can cure, prevent, or diagnose it. Cancer is a disease. Acid reflux is now a disease. Obesity is now a disease."

(PLEASE do not construe this as an endorsement of Mr. Trudeau's overall opinions. But I do think he's right on this one point.)

The stated purpose of this restrictive policy is to protect the public. Indeed, in years past before protective legislation, ineffective and even poisonous products were commonly sold as therapeutic treatments. (Remember cocaine and morphine in cold remedies? Lead and other toxic agents were also common.) Unfortunately, a huge gap has emerged as clinical data accumulates that support the efficacy of nutritional treatments and other non-traditional methods to treat or alleviate diseases. Any disease, or anything construed as disease as Trudeau points out, can onlybe treated by a drug.

In the FDA's defense, they have made slow progress in allowing "claims" of benefits for several supplements and food substances, such as the beta-glucan of oat products, soy protein, and most recently barley (for cholesterol reduction). The scrutiny is quite thorough and the wording of the policy is quite specific. Regarding oat products, for instance, the policy states:

"FDA concluded that the beta-glucan soluble fiber of whole oats is the primary component responsible for the total and LDL blood cholesterol-lowering effects of diets that contain these whole oat-containing foods at appropriate levels. This conclusion is based on review of scientific evidence indicating a relationship between the soluble fiber in these whole oat-containing foods and a reduction in the
risk of coronary heart disease.

Food products eligible to bear the health claim include oat bran and rolled oats, such as oatmeal, and whole oat flour...To qualify for the health claim, the whole oat-containing food must provide at least 0.75 grams of soluble fiber per
serving. The amount of soluble fiber needed for an effect on cholesterol levels is about 3 grams per day."


(Source: FDA Talk Paper which can be viewed in its entirety at http://www.fda.gov/bbs/topics/ANSWERS/ANS00782.html.)

In light of the boom in nutritional and non-traditional research that validate or refute efficacy, is such a policy still necessary? Or does it inhibit the open dissemination of information and result in a extraordinary monopolization of health treatment for the drug companies?

This debate will likely rage for the next two or more decades, particularly as drug companies are increasingly viewed as profit-seeking enterprises and more validation is gained by non-drug treatments.

For the moment, don't dismiss a "treatment" because it doesn't come by prescription. But don't reject a drugjust because it is a prescription. We need to strike a healthy, rational balance somewhere in between.

Can procedures alone keep you alive?

My days in the hospital remind me of what heart disease can be like when no preventive efforts are taken--what it used to be like even with my patients before taking a vigorous approach to prevention (though over 12 years ago).

Several cardiologists in my hospital, for instance, express skepticism that heart disease prevention works at all. Yes, they know about the statin cholesterol drug trials. But they claim that, given their experience with the power of coronary disease to overpower an individual's control, statin drugs are just "fluff". Coronary disease is a powerful process that can only begin to be harnessed with major procedures, i.e., a mechanical approach.

So these cardiologists routinely have their patients in the hospital, often once a year, sometimes more, for heart catheterization and "fixing" whatever requires fixing: balloon angioplasty, stents, various forms of atherectomy. Year in, year out, these patients return for their "maintenance" procedures. Their cardiologists maintain that this approach works. The patients go on eating what they like, taking little or no nutritional supplements, and medications prescribed by their primary care physicians for blood pressure, etc. But no real effort towards heart disease prevention beyond these minimal steps.

Can this work? Very little at-home, preventive efforts, but periodic "maintenance" procedures?

It can, perhaps, for a relatively short time of a few years, maybe up to 10 years. But it crumbles after this. The disease eventaully overwhelms the cardiologist's ability to stent or balloon this or that, since it has progressed and plaque has growth diffusely the entire period that maintenance procedures have been performed. In addition, acute illness still occurs with some frequency--in other words, plaque rupture is not affected just because there's a stent in the artery upstream or downstream.

Not to mention this can be misery on you and your life, with risk incurred during each procedure. It's also terribly expensive, with hospitalization easily costing $25,000-$50,000 or more each time. (Compare that to a $250 or so CT heart scan.)


As people become more aware of the potential tools for prevention of heart disease, fewer are willing to submit to the archaic and barbaric practice of "maintenance" heart procedures in lieu of prevention. But it still goes on. If you, or anybody you know, are on this pointless and doomed path, find a new doctor.




Bloodletting, another antiquated health practice

Support your local hospital: HAVE A HEART ATTACK!

I'm kidding, of course. But, in your hospital's secret agenda, that's not too far from the truth. Catastrophes lead to hospital procedures, which then yields major revenues.

Prevention, on the other hand, yields nothing for your hospital. No $8,000 to $12,000 for heart catheterization, several thousand more for a stent, $60,000-plus for a bypass, $25,000 or more for a defibrillator. In other words, prevention of heart attack and all its consequences deprive your hospital of a goldmine of revenue.

The doctors are all too often conspirators. I heard of yet another graphic example today. A man I didn't know called me out of the blue with a question. "I had a heart scan and I had a 'score' that I was told meant a moderate quantity of plaque in my arteries, a score of 157. My doctor said to ignore it. But I got another scan a year later and my score was 178. So I told this to my doctor and he said, 'Let's get you into the hospital. We'll set up a catheterization and then you'll get bypassed.' Of course, I was completely thrown off balance by this. Here I was thinking that the heart scan was showing that my prevention program needed improvement. But my doctor was talking about bypass surgery. Can you help? Does this sound right?"

No, this is absolutely not right. It's another tragedy like the many I hear about every day. Heart scans are, in fact, wonderfully helpful tools for prevention. This man was right: he felt great and the heart scan simply uncovered hidden plaque that should have triggered a conversation on how to prevent it from getting worse. But the doctor took it as a license to hustle the patient into the hospital. Ka-ching!

This sort of blatant money-generating behavior is far from rare. Don't become another victim of the cardiovascular money-making machine. Be alert, be skeptical, and question why. Of course, there are plenty of times when major heart procedures are necessary. But always insist on knowing the rationale behind such decisions, whether it's you or a loved one.

Hospitals contain experts in ILLNESS

Hospitals contain many experts in sickness. This seems obvious. But walk down the hallways of any hospital, and you'll quickly be convinced that hospitals contain almost no experts in health.

People (hospital staff, that is, not the patients) in hospitals are especially good at identifying and treating disease. They lack knowledge of health.

If your nurse is 100 lbs overweight and struggles to walk down the hall because of arthritis in both knees, would you entrust her with health advice?

If your doctor sits down in the cafeteria and eats his lunch of a ham sandwich with cheese on a bun, fried onion rings, and a milkshake and pastry, can you believe that he/she possesses any insight into health and nutrition?

If your physical therapist or cardiac rehabilitation counselor struggles nearly as much as you while climbing a single flight of stairs, can you accept their advice on how to regain your stamina and use exerise to full health advantage?

The answer to all these questions is, of course, no. Hospital staff are generally expert at dressing surgical wounds, stopping bleeding, identifying infections, and providing the support services for surgical and diagnostic procedures. In contrast, they are generally miserable at conveying genuine health advice. They certainly fall short in being examples of health themselves.

To hospitals and their staff, health is a temporary situation that persists only until you become ill. Illness is an inevitability in the hospital staff mindset. Health is a temporary state in between illnesses.

We need to shake off this perverse mentality. Health is the state of life that should dominate our practices and philosophies. Illness via the occasional catastrophe, e.g., broken leg from skiing, car accident, etc., is the province of hospitals. We should gravitate towards this philosphy and away from the over-reliance on hospitals that has come to dominate our present perceptions of health. Hospitals are not glamorous. They are, for the most part, profit-seeking businesses intent on portraying themselves as champions of health.

When I walk down the halls of hospitals, I am shocked and ashamed at the extraordinary examples of ill-health presented by hospital staff. Yet they falsely paint themselves as experts in both illness and health. Don't believe it for a second.

Are there still unexplored causes of heart disease?

I met a woman today. She had her first heart attack at age 37. She just had her 2nd heart attack this morning, at age 40.

Several issues are surprising about her story. First, she's pre-menopausal. Heart attacks before menopause are unusual. We'll occasionally see women have a heart attack before or during menopausal years only if they're heavy smokers and/or they have had diabetes (either type I or type II) for many years. But this young woman had neither. She is slender and has never smoked.

Even more surprising are her basic lipid values: LDL cholesterol 35 mg/dl, HDL 150 mg/dl, triglycerides 317 mg/dl. This is a very unusual pattern.

Unfortunately, this is all developing acutely in the hospital. (I've just met her today--she's not a Track Your Plaquer!) Lipoprotein analysis would be extremely interesting. In particular, I'd like to see whether she has any other markers besides elevated triglycerides of a "post-prandial" abnormality, i.e., persistence of abnormal particles after eating. The high triglycerides make this quite likely.

If this proves true, the omega-3 fatty acids from fish oil will be a lifesaving treatment for her, since they dramatically reduce both triglycerides as well as persistent postprandial particles like intermediate-density lipoprotein (IDL). (Track Your Plaque Members: See the Special Report on Postprandial Abnormalities on the present home page at www.cureality.com for a more in-depth discussion of this fascinating collection of patterns that is just started to be explored.)

In the real world, especially acute care medicine, there's always a kicker: she speaks no English. Unfortunately, communicating the intricacies of a powerful program like ours that aims to identify all causes of heart disease, then corrects then and aims for coronary plaque regression, is difficult if not impossible.

I also do occasionally worry that, given this woman's extraordinary risk at a young age, and overall very unusual lipid patterns (HDL 150?!), if there are causes presently beyond our reach. We have to make use of the tools available to us for now.

Everything causes heart attack!

The media are presently gushing about a recent study that associates caffeine intake with heart attack.

CBS News: That cup of coffee you're craving might not be such a good idea. Research in the September issue of Epidemiology suggests coffee can trigger a heart attack within an hour in some people.


Some reporters and their quoted sources are musing about whether it's the caffeine, cream vs. other whiteners, time of day, interaction with other risk factors, etc.

My advice: Get a grip! How many relatively benign, every day factors in life can be blamed for dire health risks?

The problem with many of these studies is that they are cross-sectional. They do not enroll participants, then "treat" with coffee (or other substance in question) vs. placebo. In other words, it is not a randomized trial, the sort of trial necessary to prove a hypothesis. That's all that can be generated by a study like this one: a hypothesis.

Perhaps there's a bit of warning for the person with uncorrected lipids and lipoproteins, has no idea that they have extensive coronary plaque because they've never had a heart scan, and have a slovenly lifestyle. Maybe that person might have exaggerated risk from a cup of coffee.

But for us, involved and intensively addressing all causes of coronary plaque to the point of stabilizing or reducing it, coffee is likely a non-issue.

For more conversation on coffee and this report, go to the www.cureality.com home page.

Excessive Heart Procedures Makes New York Times Headline


One example of flagrant cardiac procedure excess has made New York Times headlines:


Heart Procedure Is Off the Charts in an Ohio City
The number of angioplasties performed in Elyria is so high that Medicare is starting to ask questions.

(The full article can be accessed through the New York Times website at http://www.nytimes.com/2006/08/18/business/18stent.html?pagewanted=2&ei=5094&en=b81be5f43f98a99b&hp&ex=1155960000&partner=homepage)



Cardiologists in little Elyria, Ohio, about a 30-minute drive west of Cleveland, do more coronary angioplasties and insert more stents than any other location in the U.S.--four times more than the national average, three times more than the Cleveland average. They perform even more than the recently-indicted cardiologist in Louisiana, who performed twice the national average of procedures.


The Times article, part of a series about financial incentives in medical care, provides a responsible and incredibly balanced report on the situation in Elyria. I have to give them credit, because from the eyes of a colleague (myself), this looks like blatant and extreme profiteering: "cathing for dollars".

I find it outrageous that this group of cardiologists claims that they have some special insight into heart care that justifies this extraordinary reliance on heart procedures. There's bound to be variation in practice patterns, but this is so outside the norm that I believe criminal behavior will be exposed. In fact, I believe that even the "norm", or average, rate of procedures is also excessive.

This is symptomatic of the perverse equation in heart disease care. If there's money to be made in major heart procedures, who wants to bother with prevention? Programs like the Track Your Plaque program present real potential to stop coronary heart disease in its tracks for many, if not most, participants--but don't expect to hear about it from your cardiologist. Don't expect to hear about it from the increasingly hospital-employed primary care physician.

Hopefully, media exposure like that in the New York Times is just the beginning of a public re-analysis of not only what's wrong with medicine today, but recognition of the tremendous power in preventive strategies when everyone stops being so enamored with hospital-based procedures. CT-based heart scanning that ignites your heart disease prevention program is your way to dodge the mainstream obsession with procedures.

More on "Bio-identical hormones" and Wyeth Pharmaceuticals

In October 2005, Wyeth petitioned the FDA, requesting that it completely ban the bioidentical alternatives that women have been using in ever-increasing numbers to achieve optimal hormone balance. With bioidentical replacement therapy clearly reducing its market share, Wyeth asked the FDA to outlaw all compounded bioidentical hormone formulations that compete with its own discredited drugs. If Wyeth is successful, then menopausal women will have no choice other than to take potentially life-threatening hormone drugs or to forgo hormone replacement therapy altogether, thus enduring the physically and emotionally debilitating effects of menopause-induced hormone depletion.

Dave Tuttle
Life Extension Magazine
August, 2006



For more commentary on Wyeth Pharmaceutical's outrageous and brazen petition to the FDA to bar prescription "bio-identical" hormones, i.e., hormones that are identical to natural human forms, read Life Extension's article, Health Freedom Under Attack!
Drugmaker Seeks to Deny Access to Bioidentical Hormones





This well-researched article is in the August, 2006 issue of Life Extension Magazine. The article can also be accessed online at http://www.lef.org/magazine/mag2006/aug2006_cover_attack_01.htm

or go to www.lef.org and click on the August, 2006 issue.

The author, Dave Tuttle, details the baseless arguments raised by Wyeth, a pathetic and amazingly selfish act in the name of protecting profits for Premarin, their prescription agent. It's bad enough to be selling this worthless drug. It's even worse--criminal, in my mind--to try to stamp out our right to have a physician write a prescription for a pharmacy to mix up hormones identical to that humans produce, individualized to our needs.

If you are as angry about this as I am, please go to the Life Extension online reprint that provides access to the International Academy of Compounding Pharmacists website to send the FDA an e-mail describing your opinion, or go to www.iacprx.org.

How accurate is LDL cholesterol?

Watch TV and you'd get the impression that the world revolves around LDL cholesterol: Commercials for Lipitor, Zetia, Vytorin, etc., all drugs to reduce cholesterol (total and LDL). Your doctor looks first and often only at LDL cholesterol.

If there's so much attention paid to LDL, how accurate is it? 100%? 90%? 80%?

Well, it varies widely. Occasionally, it's truly accurate, but most of the time it's miserably inaccurate . Every single day, I see people with LDL cholesterols that underestimates true (measured) LDL by 40%, 50%, and even over 100%. In other words, LDL cholesterol might be 120 mg/dl by the conventional method, but the genuine measured value might be 160 mg/dl, or even 240 mg/dl. It can be that far off--and it's not rare.

The converse can occasionally be true, though rarely in my experience: that conventional LDL overestimates true LDL. I saw someone in the office today like this, with a conventional LDL of 142 mg/dl but a true measured LDL of 115 mg/dl. I may see one or two more people like this the rest of this year.




Why is LDL so inaccurate? Several reasons:

--LDL in most labs is calculated, not measured. The "Friedewald calculation" derives LDL by substracting HDL and triglycerides (divided by 5) from total cholesterol. The higher triglycerides are, especially above 150 mg/dl, the more inaccurate the calculation becomes. As HDL drops below 50 mg/dl, this also introduces greater and greater inaccuracy.

--LDL particles vary in size. A more accurate representation and measure of LDL's dangers are therefore found in measures of LDL particle number , rather than a weight-based measure or calculation. LDL particle number can be measure as just that, LDL particle number (NMR), or as apoprotein B, the protein in LDL that occurs one apoB per LDL.

I liken conventionally calculated LDL cholesterol to a broken speedometer. You simply won't have an accurate measure of how fast you're going, though you may have a ballpark sense. But try telling that to the state patrol.

Or, as a cardiologist colleague said to me in a similar conversation about LDL: "Well, it's better than nothing!"

The lesson: If you're interested in plaque control, and control or reduction of heart scan score, you need a measured LDL, preferably LDL particle number by NMR or an apoprotein B. Another option is "direct" LDL.

Green tea: friend or faux?

The www.HealthCastle.com website is a helpful website on healthy eating that sends out a free newsletter. The content is all produced by licensed dietitions and nutritionists. Although I don't agree with everything said on the site, there's still some good information.

I'm a fan of green tea. Although I believe the effects are relatively modest (weight reduction, cholesterol reduction, anti-oxidation, etc., with theaflavin and/or green tea as a beverage,) they alerted me to the fact that the Lipton Green Tea product is one you should steer clear of. Here are their comments:



"More like Soft drink than Green Tea!With 200 calories, 13 teaspoons of added sugar and a long list of artificial ingredients, Lipton Iced Green Tea is more like a bottle of soft drink than tea, in our opinion."


The Lipton website lists the ingredients:

Water, high fructose corn syrup, citric acid, green tea, sodium hexametaphosphate, ascorbic acid (to protect flavor), honey, natural flavors, phosphoric acid, sodium benzoate (preserves freshness), potassium sorbate (preserves freshness), calcium disodium edta (to protect flavor), caramel color, tallow 5, blue1.

An 8 oz serving yields 21 grams of sugar. If you drink the full 20 oz. bottle (not hard to do!), that yields 52.5 grams of sugar! You will also notice that the second ingredient listed after water is high fructose corn syrup. This ingredient, you may recall, causes triglycerides to skyrocket, causes an insatiable sweet tooth, and is a probable contributor to obesity and diabetes.

In their defense, the Lipton people do also offer a sugar-free alternative without the excessive sweeteners and empty calories.

Do the Lipton products offer the same kind of benefits from green tea catechins (flavonoids) offered by freshly brewed teas? This product has not been formally tested by an independent lab to my knowledge, though, in general, commercially prepared and bottled teas tend to have dramatically less catechin/flavonoid content compared to brewed. (The USDA website provides access to an extraordinary collection of flavonoid food content at their USDA Database for the Flavonoid Content of Selected Foods - 2003. You'll find it at http://www.ars.usda.gov/Services/docs.htm?docid=6231.)

I think the HealthCastle people got it right: Brew your own, making sure to steep for at least 3 minutes. Alternatively, a green tea or theaflavin supplement provides many of the benefits. (Theaflavin has been used in trials at doses of 375 to 900 mg per day.) An in-depth report on green tea will be coming in a future Special Report on the www.cureality.com Membership website.

Conventional therapy vs. alternative therapy

Rose is a 75-year old woman, mother of four, grandmother of many more.

Rose's story started after a heart attack 18 months ago that resulted in two stents. She was advised to follow an American Heart Association diet and take Lipitor. However, some months later, after her fourth stent, she became disilluioned in the conventional approach to heart disease and sought alternative therapies to help reduce or reverse her heart disease.

She found an alternative health practitioner who advised chelation, antioxidant vitamins for "excessive oxidation," and several homeopathic preparations.

Nothing was said about diet or exercise. Nothing was said about the baked flour products and pastries that occupied at least two meals every day. Nothing was said about the candies she indulged in several times per day, nor the soft drinks. Nothing was said about the wildly fluctuating blood sugars, poorly controlled by an oral diabetes agent. Thirty pounds of weight gain over the past 5 years with no exercise or physical activity? No comment here, too.

In short, Rose was the "graduate" of the conventional approach, as typically offered nationwide thousands of times a week. She was also the recipient of the insight of at least one alternative health practitioner, eager to reject conventional notions of how to achieve heart health.

So I then met her. She was experiencing chest pains every day, several times per day. Blood pressure over 200. At 5 ft, 3 inches, weight: 186 lbs.

Initial laboratory results:

HDL cholesterol 42 mg/dl
LDL 132 mg/dl
Triglycerides 263 mg/dl
Blood sugar 173 mg/dl


You can fill in the rest. In short, Rose was a disaster. Despite the attentions of several professionals from both the conventional as well as alternative camps, she was careening rapidly towards failure. She'd been given various crutches, Band-Aids, and salves, none of which resulted in any possibility of long-term relief from her aggressive disease.

My point: As I've said previously, all we want is truth. We want effective, rational approaches that yield real benefit. A stent? All that provides is temporary restoration of blood flow. Statin agents? They do indeed reduce LDL cholesterol. But what if Rose has 8, 9, or 10 other causes of heart disease unaffected by the statin drug? It will do little or nothing.

Nobody had addressed many of the root causes of Rose's disease: insulin resistance, high triglycerides, inactivity, obesity, hypertension (and identifying the reasons why her blood pressure was so high), vitamin D deficiency (virtually guarantted to be severe), junk foods including the ones known as "whole grains."

My message: Success in heart disease, as well as all aspects of health for that matter, doesn't necessarily have to come from an "alternative" approach, nor a "conventional" approach. It comes from applying what is truly effective, regardless of what label someone applied to it.

I would no sooner trust my health and life to an alternative health practitioner hawking unusual herbs and remedies than I would submit to a heart catheterization, three stents, followed by a statin drug. There's small benefit in both approaches, but none are the best. You've got to look elsewhere for that.


Copyright 2008 William Davis, MD

The JELIS Trial

The Japan eicosapentaenoic acid (EPA) Lipid Intervention Study (JELIS) is a clinical trial that all Track Your Plaquers should know about.

This enormous trial followed a simple design:

Japanese men, between 40-75 years, and Japanese postmenopausal women aged <75 years with total cholesterol 250 mg/dl or greater were enrolled. A total of 18,645 subjects (mean age, 61 years; 31% male) participated: 36% had hypertension, 15% had diabetes, and 20% had coronary disease (history of heart attack or heart procedure). Average starting total cholesterol 275 mg/dl; LDL 180 mg/dl. All participants were treated with pravastatin 10 mg/day or simvastatin 5 mg/day; approximately half also received the omega-3, EPA, 1800 mg/day, in addition to one of the statin drugs.

Treatment resulted in an average LDL reduction of 26% in all participants; the group taking EPA experienced an additional 10% reduction in triglycerides. All major cardiovascular events were tracked and tabulated, including sudden cardiac death, fatal or nonfatal myocardial infarction (MI), unstable angina pectoris, coronary artery bypass surgery, and coronary angioplasty.

After nearly five years, 3.5% of statin-only participants experienced an event; 2.8% of statin + EPA experienced an event. The (often misleading and frequently abused value) "relative reduction" was therefore 19%.

There are several features that make the JELIS trial interesting:

--There were an unusually low number of cardiovascular events in the entire group, lower than nearly all American and European trials of similar design. This likely points to the greater burden of atherosclerotic heart disease in the U.S. compared to Japan. Rates in comparable U.S.-based trials usually range from 6-14%, sometimes more.

--Both the participants without identified heart disease at enrollment and those with heart disease at enrollment obtained a similar magnitude of beneficial reduction in cardiovascular events.

--There was an unusual preponderance of women--69%--unlike most other trials of cardiovascular events. We might therefore argue that JELIS most conclusively showed that benefits of EPA are most confidently demonstrated for females.

--A fish oil preparation containing only EPA was used, rather than the usual EPA + DHA. There are discussions from some corners that argue that DHA is more important than EPA, e.g., algae sources. However, JELIS would argue that EPA does play a role. Is EPA with DHA better, worse, or no different? Unfortunately, there are insufficient data--large, randomized data like JELIS--to help us. Recall that GISSI Prevenzione used a combination of EPA and DHA, as have virtually all other trials examining the effects of fish oil. Also, keep in mind that the epidemiologic observations of the cardiovascular benefits of eating fish suggest that the naturally-sourced omega-3s--a combination of EPA and DHA--are associated with benefit.

--It's surprising that any difference at all was demonstrated, given the high intake of fish in the Japanese. In fact, blood levels of EPA in participants before taking EPA was five-fold higher than in western populations.


One potential difficulty: The study was funded by the manufacturer of the EPA preparation used, Mochida Pharmaceutical Company. We all know what that can do to results.

Nonetheless, the JELIS trial is a study that adds to the emerging wisdom in fish oil.


Copyright 2008 William Davis, MD

Omega-3 MUST be from fish oil

Despite my rants in this blog and elsewhere, at least once a day I'll have a patient say, "I cut back (or eliminated) my fish oil because I get my omega-3s from _______ (insert your choice of flaxseed oil, walnuts, yogurt, mayonnaise, bread, etc.)."

(See prior Heart Scan Blog post: Everything has omega-3.)

When I point out to them that the "omega-3s" in these products are not the same as the EPA and DHA from fish oil, they invariably declare, "But it says so here on the label: 'Contains 200 mg of omega-3 fatty acids'!"

Apparently, some of my colleagues have even endorsed this concept of replacing the omega-3s from fish oil with these "alternatives."

It's simply not true. The linolenic acid that is being labeled as omega-3, while it may indeed provide health benefits of its own, cannot replace the EPA and DHA that fish oil provides.

The most graphic example of the differences between the two classes of oils is in people with a condition called familial hypertriglyceridemia. People with this condition have triglyceride levels of 400, 600, even thousands of mg/dl--very high. Fish oil, usually providing EPA and DHA doses of 1800 mg per day and higher, reduce triglycerides dramatically. A person with a starting triglyceride level of, say, 900 mg/dl, may take 2400 mg of EPA and DHA from fish oil and triglycerides plummet to 150 mg/dl. This person then decides to replace fish oil with a linolenic acid source like flaxseed oil. Triglycerides? 900 mg/dl--no effect whatsoever.

Familial hypertriglyceridemia represents an exagerrated example of the differences between the two oils. Even if you don't have this genetic condition, the differences between the oils still apply.

EPA and DHA are activators of the enzyme, lipoprotein lipase, that accelerates clearance of triglycerides from the blood. Linolenic acid from flaxseed oil, walnuts, and other food sources does not. EPA and DHA block after-eating (post-prandial) accumulation of food by-products that can contribute to coronary and carotid plaque. Linolenic acid does not. EPA and DHA block platelets, reduce fibrinogen, and exert other healthy blood clot-inhibiting effects. Linolenic does not.

The 11,000-participant GISSI-Prevenzione Trial that showed 28% reduction in heart attack, 45% reduction in cardiovascular death with omega-3s used . . . fish oil.

The 18,000 participant JELIS trial that showed 19% reduction in cardiovascular events when omega-3s were added to statin therapy used . . . fish oil. (Actually, in JELIS, they used only EPA wtihout DHA.)

Linolenic acid is not a waste, however. It may exert anti-inflammatory benefits of its own, for instance. But it exerts none of the triglyceride-modifying effects of EPA or DHA.

EPA and DHA from fish oil and linolenic acid from foods each provide benefits in their own way. Ideally, you include both forms of oils--fish oil and linolenic acid sources--in your daily diet and obtain full benefit from each separate class. But they are not interchangeable.


Copyright 2008 William Davis, MD

Osteoporosis and coronary calcium

Several studies over the years have demonstrated a curious paradox:

People with more osteoporosis (thin bones) tend to be more likely to have coronary disease (heart attacks). They also tend to have higher heart scan scores (more coronary calcification as an index of atherosclerotic plaque).

People with more coronary disease and higher heart scan scores tend to have more osteoporosis.



In other words, regardless of which way you tackle the question--osteoporosis first or heart disease first--it leads to the same conclusion: Both conditions are somehow related.

I realize I harp an awful lot on this whole vitamin D issue. But, even after correcting the vitamin D blood levels of many hundreds of people, I remain enthusiastic as ever about the untapped potential of this fascinating factor.

So I couldn't resist showing this amazing comparison of how the long-term effect can be quite graphic.

The first scan is from a 46-year old man and shows normal coronary arteries without calcium and normal density of the vertebra (a common and reliable place to measure bone density).

























The second image is from a 79-year old man with both severe coronary calcification (and therefore severe coronary disease) and severe osteoporosis.
























It makes you wonder if the disordered metabolism of calcium through vitamin D deficiency allows transport of calcium away from bone and into coronaries. This has, however, been shown to not be the case. Instead, they are separate processes, each under local control, but sharing a common pathophysiology (causative factors).

An intriguing question: Would the 79-year old still look like the 46-year old had he begun increasing his vitamin D intake at, say, age 30?

About comment responses and moderation

Just a brief word about my responses to reader comments:

I appreciate the many often insightful and interesting reader comments I receive to the Heart Scan Blog. However, managing them and responding to them has simply become impossible, due to time demands.

I'm afraid that I am unable to answer questions seeking medical advice; this is for your doctor, who knows you and can diagnose and prescribe. I cannot.

I'm also unable to engage in lengthy debates; I've had commenters become very angry when I was unable to engage in lengthy conversations on some topic. Nor am I able to do Google or literature searches for commenters, or review studies, papers, or other materials.

I would urge any readers who wish to engage in in-depth discussions about these issues, talk about lipoproteins, heart disease reversal, etc. to do so on the Track Your Plaque Forums. Yes, it is a fee-for-membership website, a model that has become necessary to pay for the services we provide (not pay me).

I wish that I could answer all the concerns and questions that come my way, but it's simply physically impossible doing so while maintaining a full-time very busy cardiology practice, developing the Track Your Plaque website (which is becoming an enormous responsibility), publishing scientific data, maintaining hospital responsibilities, and spending time with my wife and family. We're all busy and I'm no different. I'm afraid that it's my responses to blog comments that I will have to sacrifice.

I invite commenters to continue to comment on these posts, as I've learned many new things by reading them and find them helpful feedback. And I do read them. Should an especially helpful comment be made, I will feature it in a new blog post, rather than respond directly.

"Flying in the fog"

I received this wonderful response to The Heart Scan Blog post Hammers and Nails:

I am 65 years old. I had a stent inserted in the "widow-maker" artery (80% blockage) a year ago. I had passed out a couple of times (heart rate dangerously low - 30s). I rode to the hospital in an ambulance. Tests revealed short LBBB episodes; mild mitral regurgitation, mild tricuspid regurgitation. Catherization showed 3 vessel CAD. I was told that a medicated stent was absolutely necessary given the situation; regardless, I have to accept that. A pacemaker was installed to prevent bradycardia and keeps heart rate from dropping below 60. I have 20% L distal main blockage and 90% lesion of the high first obtuse marginal at the takeoff. The right coronary had 60% posterior lateral branch stenosis.

Since then I have reduced TG from 360 to 60, LDL from 89 to 82 (although a few months ago it was in the mid-70s), and increased HDL from 30 to 46. I went from 265lbs to 190lbs and hope to eventually get to 180lb this Spring. I did it by progressing from walking to trotting (slow run) and dietstyle changes (low-GI veggies, fruits, etc.) .













On a recent visit the cardiologist said the the LDL needs to be 70 or below to "freeze" the 90% blockage and gave me a prescription for Lipitor. I asked if there were alternatives, like diet, supplements, etc. He admitted that he did not know about those alternative but did know Lipitor. When the only tool you have is a hammer then everything is a nail. I understand that the 90% blockage is important but will not take the Lipitor to achieve the 12 points reduction. Seems like an overkill.

I asked him if there was a way to evaluate my current condition. I was told there was no way. Basically, if I have no symptoms, good. If I have symptoms then it will have to be evaluated. Death could be the only symptom. I swear he was about to say bypass surgery ($$$$$$!) was inevitable. Something is wrong with this "fly-in-the-fog-and-hope-you-don't- hit-a-mountain" approach. Hope is not a strategy!

I am confident that I can reduce LDL to below 70 based on eliminating wheat-products in my diet plus increasing oat bran in my diet. I also take fish oil daily (EPA/DHA-2g). I am looking for a new cardiologist. I just recently purchased your book and find it very instructive. In the meantime I have an appointment with my primary care physician to discuss implementing the Track Your Plaque program. I realize that the one stent will skew the scan numbers but can be used as a baseline number.



Phenomenal weight loss! That alone has likely cut this man's risk in half. But is that it? Is the cardiologist correct--take Lipitor and hope for the best?

Of course not. There are many additional strategies to employ. Eliminating wheat from the diet is an excellent idea: HDL will skyrocket, triglycerides drop even further, small LDL will drop like a stone, blood sugar and blood pressure will drop. He will have more energy, get rid of afternoon energy slumps, sleep better.

He has already added fish oil. If his cardiologist did not mention this, I would say he was guilty of malpractice. The data supporting the addition of fish oil to the treatment program of anyone with heart disease is overhwelming. GISSI Prevenzione: 11,000 participants--28% reduction in heart attack, 45% reduction in death from heart attack. The Japanese JELIS trial of 18,645 participants--19% reduction in dangerous heart events. It's also clear that omega-3 fatty acids from fish oil also compound the benefits of statin agents, should this man choose to begin Lipitor.

Vitamin D brought to normal blood levels is his next "secret weapon" that will further boost his lipids and lipoproteins further into not just "normal" territory, but beyond belief. Even though we aim for 60-60-60 for LDL-HDL-triglycerides in the Track Your Plaque program, adding vitamin D can yield numbers you've never seen before. It's not uncommon, for instance, to see a 10 or 20 mg/dl jump in HDL.

Identify all other hidden causes of coronary plaque. If all the causes have not been fully identified, how can anyone hope to gain full control over coronary plaque growth?

Re: LDL cholesterol of 89 mg/dl at the start. Of course, this is a calculated value, not measured. Because HDL was low and triglycerides high at the start of his program, this means that true LDL--if actually measured--was probably more like 180 to 250 mg/dl, and it was probably nearly all small. So his cardiologist might have advised a helpful treatment, though for the wrong reasons.

Our reader has gone a long way on his own in creating his own prevention program. But there's yet more to do, particularly if the goal is reversal. It is shocking to me that a man like our reader, clearly articulate and motivated, gets virtually no advice beyond "take Lipitor" after all the procedural benefits have been reaped.

Even though one artery can no longer be "scored" due to the presence of the metallic stent, a heart scan would still be invaluable for long-term tracking purposes, just as we advocate in the Track Your Plaque program.



Copyright 2008 William Davis, MD

Goodbye, Dr. Jarvik

HeartWire, the news service of www.theheart.org, posted the following report:

Pfizer pulls Lipitor ads featuring Dr Robert Jarvik in HeartWire

New York, NY - After a series of questions and attacks over its choice of Dr Robert Jarvik to endorse Lipitor in a series of TV commercials, Pfizer has announced that it is withdrawing the ads. As previously reported by heartwire, Jarvik invented the first artificial heart, but he is not a cardiologist, nor does he hold a medical license—factors that drew criticism from detractors and made him and Pfizer a target of a US House Committee on Energy and Commerce investigation into celebrity endorsements in direct-to-consumer advertisements.

In a January 2008 statement, committee chair Rep John D Dingell (D-MI) observed: "Dr Jarvik's appearance in the ads could influence consumers into taking the medical advice of someone who may not be licensed to practice medicine in the United States. Americans with heart disease should make medical decisions based on consultations with their doctors, not on paid advertisements during a commercial break."

Complaints about Jarvik went up a notch this month when the latest ad in the series depicted the inventor rowing a racing scull across a lake, despite the fact that Jarvik himself does not row and the commercial used a body double.


This is typical pharmaceutical industry sleight-of-hand, now you see it, now you don't, that has come to define their policies. And this is just the stuff that comes to light because of some obvious blunders. We can only begin to imagine what sorts of other shenanigans have been swept under the rug, especially adverse effects of drugs that never made it to the light of publication.

Is this just another example of how direct-to-consumer advertising has backfired? I now have patient after patient tell me that they have been so overwhelmed and fed up with TV and magazine ads for drugs that they



Other media outlets have reported that Jarvik was guaranteed $1.35 million for the ads and that Pfizer spent $258 million on Lipitor advertisements between January 2006 and September 2007.

Hammers and nails

I'm sure you've heard the old saying that,

To a man with a hammer, everything looks like a nail.


It couldn't be truer than in heart procedures (the man with the hammer) and heart disease (the nail).

What does it take in 2008 to become an interventional cardiologist trained in all the techniques of angioplasty, stenting, intracoronary ultrasound, etc.? Start with your undergraduate degree (4 years), then medical school (another 4 years), then training in internal medicine (3 years), then general cardiology taining (3 years), then an additional year in interventional cardiology. Each step along the way also involves competing for these spaces, a process that requires much time, money, and sweat.

The total time investment is 15 years after high school. Many if not most college students graduate with debt. Pile on the substantial cost of medical school. Training after medical school pays a modest salary, enough for a single person. Many trainees by then have spouses and a family, would like to buy a house, have bills to pay. (I managed to buy my first house for $69,000 in Columbus, Ohio and paid my mortgage by sleeping only every other night and moonlighting on my off nights.)

By the time the interventional cardiologist-in-training finishes his/her 15 years, they are hungry for a hefty increase in income. After such a time and money investment, I do believe that there is at least some justification for generous income for the years of work involved.

Back to our hammer and nail metaphor. Not only do we now have a man or woman with a hammer, but a really expensive hammer that required a substantial amount of effort to obtain. Now, our hapless hammer-bearer is desperate to see everything in sight as a nail.

You're seen in consultation by this fresh interventional cardiologist in practice for only a few years. Guess what he/she advises? Go straight to the catheterization laboratory, of course. Throw in the fact that insurance reimbursement is most generous for heart procedures, far more than for consulting in the office, doing a stress test, or other simpler, non-invasive tests, and the incentives are clear.

The system, you see, is set up to follow such a path. The path to the cath lab is heavily incentivized, paths in the other direction discouraged, disparaged, or just ignored.

My message: Don't get nailed.

What is abnormal?

What is abnormal?

You'd think that the answer would be easy and straightforward.

However, consider these instances of medical findings that I have witnessed fall repeatedly into the "normal" category:

Diameter of the thoracic aorta: 4.5 cm

Mild coronary plaque by heart catheterization

Carotid plaque of 30-50%


Why isn't a thoracic aorta (the big artery in your chest) of 4.5 cm normal? Because it can be expected to increase in diameter by about 2.5 mm (0.25 cm) per year. Even at its current diameter, it means that stroke risk is greater, since enlarged aortas are diseased aortas that commonly accumulate atherosclerotic plaque with potential to fragment and shower debris to the brain. It means that high blood pressure and/or cholesterol/lipoprotein abnormalities have been uncorrected for years that have allowed the aorta to enlarge.

How about "mild coronary plaque"? Followers of the Track Your Plaque program already know the answer to this one. Mild plaque does not mean mild risk. In fact, most plaques that cause heart attack are mild plaques, not severe blockages. While severe blockages can provide symptom warning and are detected by stress tests, it's the mild blockages that rupture without symptom warning and cause heart attack. So "mild coronary plaque" is no less dangerous than severe coronary plaque.

Likewise, carotid plaque of 30-50%, while it doesn't justify surgery, can grow within just a few years to a severity that allows it to fragment and shower debris to the brain, i.e., a stroke. As with the enlarged aorta, it means that multiple causes of carotid plaque are likely active, including high blood pressure and cholesterol or lipoprotein abnormalities.

Then why would any of these findings be labeled "normal"?

Simple. In the minds of many physicians, if a condition doesn't pose immediate risk, or if it doesn't qualify for surgical "correction," then it is labeled "normal" or "mild."

Thus, an aorta of 4.5 cm cannot justify surgical replacement until it achieves a diameter of 5.5 cm. It is therefore labeled "normal."

"Mild coronary plaque" does not justify insertion of stents or performance of bypass surgery. It must therefore be "normal."

Carotid plaque over 70% is surgically removed, but not 30-50%. 30-50% is therefore "normal."

The tragedy is that many "normal" or "mild" findings, if cast in the proper light, could lead to corrective strategies that could prevent danger long-term or keep surgery from becoming necessary.

The enlarged aorta, for instance, could be stopped and an aneurysm (defined as 5.5 cm or greater) could be prevented, along with dramatically reducing risk for stroke. Carotid plaque, more so than coronary plaque, is a controllable and manipulable condition that should trigger a program of prevention and reversal. Instead, it usually generates advice to have another ultrasound in a year to see if it has yet achieved severity sufficient to justify surgery.

Of course, "mild coronary plaque" is the reason for the Track Your Plaque approach, a chance to seize control over this disease years or decades before procedures are necessary and reduce danger now, not years from now.


Copyright 2008 William Davis, MD

Niacin and hydration

Many people know about niacin's curious effect of the "hot flush," a feeling of warmth that covers the chest and neck, occasionally the entire body.

However, many people are unaware of the fact that hydration can block this effect. In fact, many people who were not advised of this will come to the office describing miserable experiences with niacin--hot flushes that last for hours, intolerable itching, etc.--only to experience little or none of these effects with generous hydration.

The vast majority of the time, two 8-12 oz glasses of water when the hot flush occurs will eliminate the flush within a few minutes.

Sometimes, the hot flush will occur many hours after taking niacin. Nine times out of ten, this delayed effect is also due to poor hydration. For instance, you might be engrossed in your work and forget to keep up with fluid demands. Or, it may be warm and you've lost fluids through sweating. That's when you begin to feel the hot flush creep up on you.

The cure: Lots of water. In this situation, in which you have allowed dehydration to develop, it may require more than two big glasses. Relief from the flush may also take more time, but it still works nearly every time.

On those rare occasions when water by itself is insufficient, then an adult (325 mg), uncoated aspirin or 200 mg ibuprofen can also be used to accelerate relief.

Why go to some much bother? Well, niacin remains the best agent we have for reduction of small LDL, raising HDL (although vitamin D is proving to be a powerful competitor in this arena), and reducing lipoprotein(a). How much do statin drugs contribute to these effects? Very little, if at all.

Several drug manufacturers are also working on "antidotes" to the hot flush effect of niacin that will be packaged within the niacin tablet. Naturally, it will also boost the cost up many times higher.

In the meantime, if or when you experience the niacin hot flush, just think: Put out the "fire" with plenty of water.