(Lack of ) Quality of nutritional supplements

16. May 2007 William Davis (0)

In my last post, I blogged about how we must not confuse marketing with truth. They are often two different things.

A patient I saw today was absolutely convinced that his fish oil was the best available in the world: purer, uncontaminated by mercury or pesticides--"not like that other crap on the shelves." I asked him how he knew this. "They say so," he proudly declared.

Do you recognize this? He fell for the marketing. While there may be some truth in the manufacturer's claims, you can't believe it from the mouth of the manufacturer. True judgements about quality and purity have to come from an independent source like Consumer Reports, Consumer Lab, or the FDA.

But the FDA doesn't regulate the quality and purity of nutritional supplements. On the positive side, this has allowed supplement manufacturers to keep costs down, not having to navigate arcane and complex regulatory restrictions.

On the negative side, a fair number of supplement manufacturers get away with 1) producing supplements that fail to contain the stated amounts of ingredients, occasionally containing none of the essential ingredient(s), 2) contain contaminants like lead, and 3) make extravagant and often unfounded claims like "superior", "more effective", and "purer". (DHEA, for instance, is a particular landmine of poor quality. I recently suggested that a patient take DHEA; despite consistently taking 50 mg of a specific brand for several months, the blood level of DHEA-S didn't budge one bit--there was likely little or none in the capsule.)

The Fanatic Cook at http://fanaticcook.blogspot.com has posted some very insightful discussions on this issue and the proposed FDA regulations of supplements. They're worth perusing.

I really wish regulation weren't necessary and that the industry could have policed itself. But it clearly has failed and perhaps federal oversight is not such a bad thing, as long as the FDA regulations restrict themselves to oversight over quality and purity and not to efficacy. It's the efficacy regulation that could hogtie innovation in supplement development.

Marketing and truth are not the same

15. May 2007 William Davis (0)

I often remind people: Don't confuse marketing with the truth.

Today, I spent a total of probably an hour and a half dissuading patients that some crazed piece of marketing trying to sell them something was not the same as truth.

I spent approximately 40 minutes alone with a woman who was absolutely convinced that:

--Nattokinase would cure her of all heart disease. It does not. Despite the promising health benefits of natto and vitamin K2 supplementation, nattokinase is a scam with no basis in science nor logic.

--Niacin destroys your liver and homeopathic remedies are superior. Quite simply, homeopathy = quackery. No rational thinking scientist endorses the utter nonsense practiced in this strange and outrageous set of practices that requires you to suspend all reason.

--Sufficient vitamin D is obtainable through a "potent" multivitamin. I know of no multivitamin preparation that even begins to provide the dose of vitamin D that is actually required by adults, nor is it absorbed since these D preparations are powder based.

--Fish oil will poison you with mercury. Accordingly, one brand of fish oil claims to be the only safe form. Those of you following these posts, or the reports of the USDA and FDA, as well as the reports of Consumer Reports and Consumer Lab (www.consumerlab.com) know that, unlike fish itself, there is no mercury in fish oil capsules.

--All coronary atherosclerotic heart disease is caused by heavy metal poisoning. Thus chelation with EDTA represents a cure for heart disease.

People are inundated with marketing that promise extravagant cures, remove need for any medication, make you smarter, sexier, thinner, and on and on.

If you see a TV ad for Ford that says they make the best cars in the U.S., do you immediately run out and put a For Sale sign on your GM car and buy a Ford? No, of course not. You recognize the ad for what it is: marketing. It may be true, but a TV commercial is not enough to convince you.

Then why would an ad promising extraordinary cures for cancer or heart disease convince you that this is true? It should not. Marketing ads should only serve to alert you to the possibility of value or benefit, but should never-- never--stand alone as proof. Take marketing for what it is: marketing of a product or service, not a scientific report, not a factual report, not news.

Marketing is advertising. Period.

More on erectile dysfunction

13. May 2007 William Davis (8)

Several facts on erectile dysfunction and coronary plaque:

If you have erectile dysfunction, there's at least a 50% chance you also have coronary plaque.

If you have coronary plaque by a CT heart scan, there's a 50% chance you have erectile dysfunction.

If you have symptomatic coronary disease (chest pains, breathlessness, prior heart attack), there's a 90% chance you also have erectile dysfunction.

Coronary disease is characterized by a dysfunctional state of the "endothelium", or inner lining of the coronary arteries. Erectile dysfunction is characterized by dysfunction of the endothelium of the penile circulation. Same phenomenon, different territories. (There are other differences, of course, but the two conditions share this fundamental phenomenon.)

If you have any doubts about the physiologic effects of the supplement, l-arginine, just give it a try if you have erectile dysfunction. The erection enhancing effects alone should convince you that a genuine artery-dilating effect is exerted by this very powerful nutritional supplement.

If l-arginine fails by itself to restore full erectile capacity, there are additional strategies, both nutritional and medical, that you can consider.

Our newest Track Your Plaque Special Report on erectile dysfunction is coming out any day now.

High LDL cholesterol--only

11. May 2007 William Davis (3)

As a sequel to my last post, just how often can we blame an isolated high LDL cholesterol as the cause of coronary plaque and a heart scan score?

In other words, how often does someone prove to have only LDL cholesterol as the cause of a heart scan score . . . and nothing else? No low HDL, small LDL, lipoprotein(a), a post-prandial (after-eating) intermediate-density lipoprotein, inflammatory responses, phospholipase A2, high triglycerides, vitamin D deficiency, etc.

Rarely. In fact, I can truly count the number of people who have only LDL cholesterol as their sole cause of coronary atherosclerotic plaque on one hand. It is really an infrequent situation.

Far more commonly, people have 5, 6, 7 or more reasons for coronary plaque.

Thus, the idea that a statin drug to reduce LDL will cure heart disease is completely folly. It does happen--but rarely. I think I've seen it happen twice. Much more commonly, a program that addresses all the causes of coronary plaque yields far superior benefits.

In my view, an effort to identify all the causes is relatively easy, makes far better sense, and provides you much greater assurance that you will succeed in conquering heart disease and removing its evil influence from your life.

Heart disease = statin deficiency

10. May 2007 William Davis (1)

Judging from the conversations I hear from colleagues, what I hear from the media, and drug company advertising, you'd think that heart disease has one cause--a deficiency of statin drugs.

As their thinking goes, if you have coronary disease, you need a statin drug (Lipitor, Zocor, Crestor, pravachol, etc.). If you have progressive coronary disease, you need more statin drug. If you have a heart attack while on a statin drug, you need even more statin drug.

Some "experts" have even proposed that we do away with LDL cholesterol and we just give everybody a statin drug at high doses.

Does this make any sense to you?

Doesn't it make better sense that if someone has progressive heart disease or heart attack while on a statin drug, then target the other causes largely unaffected by a statin drug? Perhaps if LDL cholesterol remains high on the statin drug, then a higher dose is justified. But more often than not, it's not a high LDL on statin drugs that responsible, it's other causes. And there's many of them: low HDL, VLDL, IDL, Lp(a), deficiency of omega-3 fatty acids, inflammatory processes, vitamin D deficiency, among others. (An important exception to this is when the conventional calculated LDL substantially underestimates true LDL as measured by LDL particle number by NMR, apoprotein B, or 'direct' LDL.)

Imagine someone has pneumonia. After 2 weeks of antibiotics, they are only partly better. The solution: a higher dose of the same antibiotic--but never question if it was the right antibiotic in the first place. That's what is going on in heart disease.

The doctors have been brainwashed into believing this $22 billion dollar per year bit of propaganda. The drug companies actively try to recruit the public into believing the same. Don't fall for it.

The statin drugs do indeed have a role. But they are not the complete answer. More of the same when disease progresses makes no sense at all.

Fish oil and mercury

9. May 2007 William Davis (2)

I often get questions about the mercury content in fish oil. I've even had patients come to the office saying their primary care doctor told them to stop fish oil to avoid mercury poisoning.

Manufacturers of fish oil also make claims that this product or that ("super-concentrated", "pharmaceutical grade", "purified", etc.) is purer or less contaminated than competitors' products. The manufacturers of the "drug" Omacor, or prescription fish oil, have added to the confusion by suggesting that their product is the most pure of all, since it is the most concentrated of any fish oil preparation (900 mg EPA+DHA per capsule). They claim that "OMACOR is naturally derived through a unique, patented process that creates a highly concentrated, highly purified prescription medicine. By prescribing OMACOR® (omega-3-acid ethyl esters), a prescription omega-3, your doctor is giving you a concentrated and reliable omega-3. Each OMACOR capsule contains 90% omega-3 acids (84% EPA/DHA*). Nonprescription omega-3 dietary supplements typically contain only 13%-63% EPA/DHA."

How much truth is there in these concerns?

Let's go to the data published by the USDA, FDA, and several independent studies. Let's add to that the independent (and therefore presumably unbiased) analyses provided by Consumer Reports and Consumer Labs (www.consumerlab.com). How much mercury has been found in fish oil supplements?

None.

This is different from the mercury content of whole fish that you eat. Predatory fish that are at the top of the food chain and consume other fish and thereby concentrate organic methyl mercury, the toxic form of mercury. Thus, shark, swordfish, and King mackerel are higher in mercury than sardines, herring, and salmon.

The mercury content of fish oil capsules have little to do with the method of processing and much more with the animal source of oil. Fish oil is generally obtained from sardines, salmon, and cod, all low in mercury. Fish oil capsules are not prepared from swordfish or shark.

Thus, concerns about mercury from fish oil--regardless of brand--are generally unfounded, according to the best information we have. Eating whole fish--now that's another story for another time. But you and I can take our fish oil to reduce triglycerides, VLDL, IDL, small LDL, and heart attack risk without worrying about mercury.

How much omega-3s are enough?

8. May 2007 William Davis (7)

The basic dose we advocate for the Track Your Plaque program is 1200 mg per day of EPA + DHA, the essential omega-3 fatty acids.

1200 mg EPA+DHA is generally obtainable by taking 4 capsules of 1000 mg of fish oil, since the majority of preparations contain 180 mg EPA and 120 mg DHA per capsule.

But how will you know if a higher dose wouldn't be even better?

The principal parameter to look at is triglycerides. If triglycerides remain above 60 mg/dl, we usually consider increasing fish oil.

Another measure that's very important is intermediate-density lipoprotein, or IDL, also called "remnant lipoproteins" on a VAP panel. Persistence of any IDL or remnant lipoproteins is reason to consider more fish oil. Most commonly, if there is some persistence of either, we increase fish oil to 6000 mg per day of a standard preparation, or 1800 mg/day of EPA+DHA.

The only time we see persistence of IDL or remnant lipoproteins with this higher dose is when triglycerides are really high. If starting triglycerides are, for instance, 500 mg/dl, then even this higher dose may be insufficient. This is when more highly concentrated preparations of fish oil may be necessary, occasionally even the prescription form, Omacor. (We currently use Omacor only when high doses of EPA+DHA are required, most because of its outrageous cost. Two capsules per day costs around $120 per month; three capsules per day to provide 1800 mg/day of EPA+DHA costs $180 per month. I think this is outrageous and so we use it only when absolutely necessary.)

You might even argue that a higher dose of 1800 mg EPA+DHA, or 6000 mg of a standard capsule, might be preferable for more assured reduction of heart attack risk--even when triglycerides and IDL are perfectly under control. I wouldn't argue with you. But you won't observe any measurable feedback that tells you that a heightened effect is being obtained. I take that dose myself, in fact, despite the fact that elimination of wheat products and weight loss was sufficient to drop my triglycerides to the target level. I figure it's a small additional effort for added peace of mind.

Repentance for past sins

7. May 2007 William Davis (0)

If you are new to the Track Your Plaque program and would like to jump start your effort, or if you are struggling with losing weight and excess weight is a part of the situation that created your CT heart scan score, then don't forget about fasting.

Fasting is the cessation of eating. However, recall from the Track Your Plaque Special Report, Fasting: Fast Track to Control Plaque at http://www.cureality.com/library/fl_04-012fasting.asp, there are many variations on fasting that permit some intake of healthy foods. (Thus, they are not, in the strict sense, "fasting". Accurate or no, there are variations that may be more palatable or do-able in the real world by real people.)

My personal favorite method to fast is to use a low-sugar, low-fat soy milk such as Light Silk, available at most major grocery stores. This high-protein, low-fat, low-sugar soy milk takes the edge off hunger and provides a minimal quantity of calories. A minimum of 72 hours is required for substantial results. (My one reservation about this brand of soy milk is that the Fanatic Cook claims that the manufacturer, Dean Foods, is a factory farm operation that abuses livestock--a discussion for another day.)

Fasting yields more than weight loss. It refreshes your appreciation for food. It reawakens you to the amount and quality of food you've been putting in your body. Fasting also allows you to recognize just how bad you might feel from the diet you were eating.

You also emerge from a fast with a reduced appetite and a renewed sense of appreciation for food. It makes the discipline of healthy eating a lot easier when you break your fast.

I tell people that fasting is not punishment. It is a form of enlightenment, of re-experiencing food and life. Fasting allows you to "catch up" on all the indiscretions you've been guilty of over the years.

It also provides enormous advantage in gaining control over coronary plaque.

A fanatic for Fanatic Cook

6. May 2007 William Davis (1)

If you haven't already done so, I'd urge you to peruse the wonderfully insightful, sophisticated, and biting commentary provided by the Fanatic Cook Blog at http://fanaticcook.blogspot.com.

She (I assume it's a she) has been discussing the proposed Safe Food Act recently, an effort to address all the dangers in foods that have come to attention lately, like melamine in pet food and E. coli in bagged spinach. Her most recent post is:

Nebraska Farm Bureau Thinks Food Safety Act Bad Idea, the latest in a series of posts exploring this issue.

I'd like to know who the Fanatic Cook is, or "Bix" as she calls herself. (I assume it's a "she" but I don't really know that for a fact.) I've corresponded with her and she prefers to remain anonymous for unspecified reasons. I'd like to know who this person is both for a more secure sense of credibility, as well as I'd simply like to know who can write so intelligently and why. I suspect that she's a professional nutrition scientist or something along those lines, since the level of insight into many scientific issues is quite impressive. Her Blogs will make great material for a book, if compiled and organized. Watch out for this one.

Erectile dysfunction and coronary plaque

6. May 2007 William Davis (5)

Erectile dysfunction (ED), previously known as "impotence," and coronary atherosclerotic plaque go hand in hand.

A recent study in men with advanced coronary disease showed that 93% experienced ED. The participants in the Track Your Plaque program, for the most part, do not have advanced coronary atherosclerosis, but have an earlier form detected by a CT heart scan.

What proportion of men with asymptomatic coronary plaque as measured by a CT heart scan have ED? Around 50%. In other words, it's not a rare occurrence.

The conversation about ED (and even its renaming from impotence) really gained momentum with the development of ED-drugs like Viagra and Cialis. The drugs are reasonably effective and safe. However, you will hear little about all the strategies that can either precede your need for these drugs and/or enhance your response to these drugs if the response is partial. That part of the conversation, of course, doesn't yield loads of drug company revenues.

One of the most helpful and specific nutritional supplements available that can partially restore the nitric oxide-deficiency of ED is l-arginine. L-arginine is the body's source of nitric oxide (NO), the master dilator (relaxing agent) for all arteries of the body. NO dilates penile arteries, it dilates coronary arteries. Lack of NO disables the penile capacity for erection and encourages growth of coronary atherosclerotic plaque. Track Your Plaque Members are already familiar with l-arginine as a facilitator of coronary plaque regression.

We will detail the supplements that you can use safely in your Track Your Plaque program to both enhance erectile function if you suffer ED, as well as impact positively on coronary health, in an upcoming and detailed Special Report on the www.cureality.com website.

All posts by william-davis

The “Heart Healthy” scam

27. July 2008 William Davis (1)

Like many scams, this one follows a predictable formula.

It is a formula widely practiced among food manufacturers, ever since food products began to jockey for position based on nutritional composition and purported health benefits.

First, identify a component of food, such as wheat fiber or oat bran, that confers a health benefit. Then, validate the healthy effect in clinical studies. Wheat fiber, for instance, promotes bowel regularity and reduces the likelihood of colon cancer. Oat bran reduces blood cholesterol levels.

Second, commercialize food products that contain the purported healthy ingredient. Wheat bran becomes Shredded Wheat, Fiber One, and Raisin Bran cereals and an endless choice of “healthy” breads. Oat bran becomes Honey Bunches of Oats, Quaker’s Instant Oatmeal, and granola bars. Even if many unhealthy components are added, as long as the original healthy product is included, the manufacturer continues to lay claim to healthy effects.

Third, as long as the original healthy ingredient remains, get an agency like the American Heart Association to provide an endorsement: “American Heart Association Tested and Approved.”

The last step is the easiest: just pay for it, provided the product meets a set of requirements, no matter how lax.

You will find the American Heart Association certification on Quaker Instant Oatmeal Crunch Apples and Cinnamon. Each serving contains 39 grams carbohydrate, 16 grams sugar (approximately 4 teaspoons), and 2.5 grams fat of which 0.5 grams are saturated. Ingredients include sugar, corn syrup, flaked corn, and partially hydrogenated cottonseed oil. Curiously, of the 4 grams of fiber per serving, only 1 gram is the soluble variety, the sort that reduces cholesterol blood levels. (This relatively trivial quantity of soluble fiber is unlikely to impact significantly on cholesterol levels, since a minimum 3 grams of soluble fiber is the quantity required, as demonstrated in a number of clinical studies.) Nonetheless, this sugar product proudly wears the AHA endorsement.

Thus, a simple component of food that provides genuine benefit mushrooms into a cornucopia of new products with added ingredients: sugar, high fructose corn syrup, corn starch, carageenan, raisins, wheat flour, preservatives, hydrogenated oils, etc. What may have begun as a health benefit can quickly deteriorate into something that is patently unhealthy.

There’s a clever variation on this formula. Rather than developing products that include a healthy component, create products that simply lack an unhealthy ingredient, such as saturated or trans fats or sodium.

Thus, a ¾-cup serving of Cocoa Puffs cereal contains 120 calories, no fiber, 14 grams (3 ½ teaspoons) of sugar—but is low in fat and contains no saturated fat. Proudly displayed on the box front is an American Heart Association stamp of approval. It earned this stamp of approval because Cocoa Puffs was low in saturated, trans, and total fat and sodium. Likewise, Cookie Crisp cereal, featuring Chip the Wolf, a cartoon wolf in a red sweater (“The great taste of chocolate chip cookies and milk!”), has 160 calories, 26 grams carbohydrate and 19 grams (4½ teaspoons) of sugar per cup, and 0 grams fiber—but only 1.0 gram fat, none saturated, thus the AHA check mark. (Promise margarine, made with hydrogenated vegetable oil and therefore containing significant quantities of trans fats, was originally on the list, as well, but removed when the trans fat threshold was added to the AHA criteria.)

It is this phenomenon, the sleight of hand of taking a healthy component and tacking on a list of ingredients manageable only by food scientists, or asserting that a product is healthy just because it lacks a specific undesirable ingredient, that is a major factor in the extraordinary and unprecedented boom in obesity in the U.S. Imagine the chemical industry were permitted such latitude: “Our pesticide is deemed safe by the USDA because it contains no PCBs.” Such is the ill-conceived logic of the AHA Heart-Check program the "Heart Healthy" claims.

It’s best we keep in mind the observations of New York University nutritionist and author of the book, Food Politics, Marion Nestle, that “food companies—just like companies that sell cigarettes, pharmaceuticals, or any other commodity—routinely place the needs of stock holders over considerations of public health. Food companies will make and market any product that sells, regardless of its nutritional value or its effect on health. In this regard, food companies hardly differ from cigarette companies. They lobby Congress to eliminate regulations perceived as unfavorable; they press federal regulatory agencies not to enforce such regulations; and when they don’t like regulatory decisions, they file lawsuits. Like cigarette companies, food companies co-opt food and nutrition experts by supporting professional organizations and research, and they expand sales by marketing directly to children, members of minority groups, and people in develop countries—whether or not the products are likely to improve people’s diets.”

Qualms over just how heart-healthy their products are? Doubtful.

Exploitation of trust

25. July 2008 William Davis (5)

Once upon a time, the tobacco industry was guilty of conducting a widespread, systematic, highly organized campaign to deliver their product to as much of the unsuspecting public as possible.

As clinical data mounted linking smoking and health problems like cancer and heart disease, tobacco producers labored fiercely to counter these claims despite darkening public sentiment. When individual company executives were questioned on why they continued to perpetuate the industry’s scandalous practices, the invariable justification offered was “Well, I had to pay my mortgage.” That tidy ends-justifies-the-means rationalization has a familiar ring when you examine the behavior of those in the heart "industry."

Things are not what they seem. The hospital, once an institution to serve the sick, a place for clergy, volunteers, and other altruists, has evolved into a business serving a thriving bottom line. You are the “product” they seek. The cardiologist, ostensibly in the service of alleviating heart disease, instead seeks to grow his checkbook by performing procedures that have nothing to do with lessening the burden of heart disease. He dives into the water to save drowning victim after drowning victim, but fails to simply toss in the life preserver that has been close at hand all along.

The woeful family practitioner, who is expected to bear undue responsibility for the broad spectrum of health, ignorantly permits heart disease to grow under his or her nose and, by default, allows heart disease to become the exclusive province of the proceduralist. Worse, the family practitioner or internist in the employ of the hospital (a situation that has quietly grown to encompass 80% of all primary care physicians) labors to fatten hospital business by directing patients into hospital services. The comparative lowly incomes of the primary care physician are substantially supplemented by participating in this huge revenue-generating machine called heart care.

The astounding grasp of the system has caused one of every 10 adults in the U.S. to have undergone a heart procedure. The lemming-like procession to the hospital creates a crowd mentality among some sectors of the frightened public. “My friends and neighbors have all had bypass operations. Sooner or later I guess it’s going to be my turn.”

Tragically, the system has grown through the exploitation of trust. The faith we have in doctors, hospitals, and the institutions and people associated with healthcare has been subverted into the service of profit. Many practitioners and institutions choose to operate under the guise of doing good, but instead capitalize on the public’s willingness to accept as fact the need for major heart procedures and all its associated costly trappings.

Bait and switch

24. July 2008 William Davis (0)

"When banks compete, you win.”

The TV ad opens with a 60-something man sitting in his living room, talking to a three-piece suit-clad, 30-something banker. The older man is explaining to the dismayed younger man why he’s going to use Lending Tree loan service for a home loan.

“But Dad, I’m you’re son!” the younger whines.

Many of Lending Tree’s clients have collaborated in filing a multi-million dollar class action suit against the company, claiming “bait and switch” tactics. They claim that home buyers are lured by low interest rates or low closing costs on a home loan. Once the buyer concludes the hassle of filling out numerous forms, the suit accuses Lending Tree of making a switch to a costlier loan.

Bait and switch is among the oldest con games around. If you’ve ever bought a car from a car dealer, chances are you’ve had your own little brush with this deception. The ad promises the SUV you’ve wanted for only $299 per month. Only, once you get there, the salesman informs you that only a limited number of special deals were available and they’ve run out. But he’s still got a really good deal right over here!

Most of us recognize that we’ve been hookwinked. Yet we still go along and buy a car from the dealer.

What if it’s not a sleazy salesman behind the pitch, but a physician. If it’s hard to resist the sales pitch at the car dealership, it can be near impossible to ignore the advice of your doctor. But the truth is often loud and clear: in many instances, it is a genuine, bona fide, and fully-certified scam.

Among the most common bait-and-switch heart scams: Your cholesterol is high. The sequence of subsequent testing is well-rehearsed. “Gee, Bob, I’m worried about your risk for heart disease. Let’s schedule you for a nuclear stress test.”

The stress test, like 20% or more of them, is “falsely positive,” meaning abnormal even though there’s nothing wrong with you. Another 30% are equivocal, not clearly abnormal but also not clearly normal. Now up to 50% of people tested “need” a heart catheterization in the hospital to clarify this frightening uncertainty. You might end up with a stent or two, even bypass surgery. Your simple $20 cholesterol panel has metamorphosed into $100,000 in hospital procedures.

That familiar sequence is followed thousands of times, seven days a week, 365 days a year.

If a disease lacks a procedure . . . create one

24. July 2008 William Davis (1)

Congestive heart failure is among the most common diagnoses in the hospital nowadays.

Congestive heart failure is the result of injury to the heart muscle such as that occurring during heart attack, viral infections of the heart (myocarditis), poorly controlled high blood pressure, and a smattering of other rare causes. Eight million Americans with congestive heart failure account for over one million hospital admissions annually (AHA Update, 2007). It has become so common, in fact, that it has ranked as number one cause for hospital admission for the last several years.

Heart failure is a frightening condition causing the sufferer to gasp for breath. Excess fluid accumulates in the lungs, amplifying the work of breathing and imparting a feeling of unease. Some heart failure sufferers struggle to the point of blacking out or requiring mechanical ventilation on a respirator.

There are a number of standard treatments for heart failure that usually rapidly rescue the patient from the brink of respiratory failure. These generally consist of intravenous diuretics that force the kidney to clear excess water rapidly, medications to increase heart muscle strength, and other treatments. It’s not uncommon for a heart failure patient to drop 10–20 lbs. in water weight with treatment. The treatments are quite effective for the majority of patients with rapid relief of the breathlessness generally obtained within hours.

However, the problem with congestive heart failure is not generally the rapidity or effectiveness of acutely providing relief, it is the chronic recurring nature of the disease. Someone can come to the hospital, obtain prompt treatment with relief of the breathlessness within 48–72 hours, only to return to the hospital in several weeks with a recurrence of the same process.

As common as congestive heart is in hospitals, it has also presented the perennial problem: how to convert this frequent reason for hospitalization into a profit opportunity. Some people who experience heart failure will undergo the usual sequence of heart procedures of heart catheterization, stents, bypass surgery, valve surgery, etc. But, because heart failure tends to be a repeatedly recurring event, even patients tire of the “need” for heart procedures. Then how can more heart failure occurrences be converted into profitable events?

A unique principle operates in the medical device market: If a disease lacks a procedure . . . create one.

Several problems are solved by such a principle. First, procedures are much more generously reimbursed by insurers than standard medical care without procedures. Two, the physician is provided an opportunity to also bill at a higher level. Third, patients often love the more dramatic, heroic nature of procedures, whether or not there is true benefit.

To the rescue of the poorly reimbursed area of congestive heart failure walks a Minnesota company called CHF Solutions, Inc., manufacturers of the Aquadex device.

Cost? $14,500 plus $900 per filter every time a patient gets one treatment. The Aquadex works by a decades-old process called ultrafiltration, used for many years but used principally for kidney failure not severe enough to require regular dialysis. New York cardiologist Howard Levin simply adapted the process, using smaller catheters inserted into the arm veins, in 2000. As in conventional ultrafiltration, blood is taken from the body from a catheter, passed through a filter that removes excess water, then returned to the body.

This is a serious effort. Dr. Levin raised $51 million in venture backing on top of $12 million seed capital. The device sailed through the Food & Drug Administration in June 2002, since it was labeled a newer form of ultrafiltration, thereby obtaining approval through the FDA’s 501k rule, a minor modification of existing technology. (Many truly technologically unique devices do come to market and therefore require the full process of FDA approval, a generally lengthy and costly process for devices. However, there’s another way: bill a device as “substantially equivalent” to an existing technology and the approval process is relatively quick and easy.)

In an industry publication, Cath Lab Digest, Dr. Levin was interviewed in February, 2003, and proclaimed, “We can treat many of the symptoms of heart failure, but we’re a long ways off from a cure. That’s why new technologies are so exciting, such as LVADs for the very sickest heart failure patients; biventricular pacing for the small subset of patients who seem to benefit from it; and simplified ultrafiltration such as the System 100 that can be applied to a broad range of congestive heart failure patients with fluid overload. “

What does this have to do with heart scans and heart disease reversal? Nothing-directly. I highlight this phenomenon because it caricatures how things work in medicine and health care in general, more so in cardiovascular diseases in which the profit motive is especially deeply ingrained. Focus on a need, then generate a profitable treatment for it. Profits are what drive growth, marketing, sales, and expansion into new revenue-generating niches.

Sadly, the reverse principle does not work: Replace profitable procedures with unprofitable strategies, regardless of their effectiveness. Replacing coronary angioplasty and coronary stent implantation, or bypass surgery, with intensive prevention efforts is no easy matter. Just witness the enormous resistance to the concept of early heart disease detection achieved with heart scans. A day doesn’t go by without a major media outlet bashing heart scans, or confusing them with CT coronary angiograms with claims of excessive radiation.

But the mounting volume of criticisms against heart scans also means that they are gaining some traction in mainstream thinking. But will there be a day when they replace the need for profitable procedures? I believe they will, when coupled with a powerful program of prevention, but don’t hold your breath.

Blood sugar lessons from a Type I diabetic

23. July 2008 William Davis (15)

A friend of mine is a Type I, or childhood onset, diabetic. He's had it for nearly 50 years, since age 6. He's also in the health industry and is a good observer of detail.

He made the following interesting comments to me recently when talking about the effects of various foods on blood sugar:

"When I eat normally, like some vegetables or salad and meat, I dose up to 10 units of insulin to control my blood sugar.

"If I eat a turkey sandwich on two slices of whole wheat, I usually dose 15 units. The bread makes my blood sugar go to 300 if I don't.

"If I eat a Cousins's Sub [a local submarine sandwich chain], I dose 15 units. The bread really makes my blood sugar go up.

"I can only eat a Quarter Pound from McDonald's once a year, because it make my blood sugar go nuts. I dose 15-20 units before having it, and I feel like crap for two days afterwards.

"If I eat Mexican food, I have to dose 15-20 units. For some reason, it's gotten worse over the years, and I need to dose higher and higher.

"Chinese food is the absolute worst. I dose 20-25 units before eating Chinese. I'll often have to dose more afterwards, because my blood sugar goes so berserk."

Nothing beats the real-world observations on the impact of various foods on blood sugar than the observations of people with Type I diabetes. All the insulin they get is in a syringe. Dosing needs to match intake.

Personally, though I love the taste of Americanized Chinese food, I've always been suspicious of what exactly goes into these dishes. But I was unaware of the blood sugar implications.

The impact of Mexican I believe can be attributed to the cornstarch used in the tacos and tortillas, though I also wonder if there are other starches being snuck in, as well.

Lessons about omega-3s from Japan

23. July 2008 William Davis (7)

Image courtesy of apc33.

Japan provides a useful "laboratory" for studying the effect of a culture that relies heavily on eating fish.

The JELIS Trial, the topic of a previous Heart Scan Blog post, showed that supplementation with the single omega-3 fatty acid, EPA, 1800 mg per day (the equivalent of 10 capsules of 'standard' fish oil that contains 180 mg per day of EPA, 120 mg of DHA) significantly reduced heart attack in a Japanese population. Interestingly, this benefit was additive to the already substantial intake of omega-3 fatty acids among the general Japanese population, a population with a fraction of the heart attacks found in western populations like the U.S. (approximately 3% over 5 years in Japanese compared to several-fold higher in a comparable American group).

While there may be genetic and other cultural and lifestyle reasons behind the dramatically reduced cardiovascular risk in Japanese, it is undeniably at least partially due to the increased intake of omega-3 fatty acids from fish. Incidentally, the purported benefits of omega-3 fatty acids provide a vigorous counter-argument to the idea that all humans should be vegetarians.

Anyway, if we were to take some lessons from the Japanese and their greater habitual intake of omega-3 fatty acids from fish, they might include:

--Rural and coastal Japanese are the sub-populations with the highest reliance on fish, about a quarter-pound a day. (Gives new meaning to the idea of a "Quarter Pounder," doesn't it?) This is at least five-times greater than the intake of an average American.

--Likewise, the blood level of omega-3s in the blood of Japanese is 5-fold higher than in Americans.

--The average intake of omega-3s (EPA + DHA) among a broadly-selected population of Japanese is 850 mg per day (320 mg EPA; 520 mg DHA). Intake ranges from 300 mg per day all the way up to 3100 mg per day.

--Greater omega-3 intake (EPA + DHA) is associated with lesser carotid intimal-medial thickness, an index of body-wide atherosclerosis.

--Japanese have far less heart attack and stroke despite greater prevalence of smoking (nearly half of Japanese) and drinking.

--Total fat intake (percent of calories) is nearly identical between Americans and Japanese. It's the proportion of fat calories from omega-3 that is greater, the proportion of omega-6 that is less in Japanese.

The Japanese eat their fish in ways that we do not: As sashimi (raw, as with sushi in its various forms like Nigiri and Chirashi); fried in tempura; shaved, dried fish sprinkled on about anything you can imagine (it's not as bad as it sounds); as a snack, as in dried cuttlefish (which you can purchase in packages as a portable, sweetened fish that you eat on-the-run--I know it sounds awful, but don't poke fun at it until you've tried it); in "soups" with soba noodles. Fish is commonly consumed with rice and soy sauce, as well as other soy-based foods, such as tofu, miso (soy bean paste), or natto.

I believe that there are some lessons to take from the Japanese and their fish-consuming habits:

1) An omega-3 fatty acid intake of at least 1000 mg per day yields measurable cardiovascular benefits.

2) Despite the fears over mercury and pesticide residues in fish, this seems to not have played out to be a real-life effect in the Japanese, who consume five-fold greater quantities of fish.

3) My mother was right after all when she encouraged us to eat more fish.

DIRECT Study result: Low-carb, Mediterranean diets win weight-loss battle

19. July 2008 William Davis (14)

Drs. Iris Shai and colleagues released results of a new Israeli study, the Dietary Intervention Randomized Controlled Trial (DIRECT) Trial, that compared three different diet strategies. Of those tested, a low-carbohydrate diet was most successful at achieving weight loss.

You can find the full-text of the study on the New England Journal of Medicine website.

322 participants followed one of three diets over two year period. Compared head-to-head, the (mean) weight loss in each group was:

• 2.9 kg (6.4 lbs) for the low-fat group
• 4.4 kg (9.7 lbs) for the Mediterranean-diet group
• 4.7 kg (10.3 lbs) for the low-carbohydrate group

(Average age 52 years at start; average body-mass index, or BMI, 31.)

The conclusion was that the low-carb diet performed the best, with 60% greater weight loss, with the Mediterranean diet a close second.

The diets

The low-fat diet was based on the American Heart Association diet, with 30% of calories from fat (10% from saturated fat) and food choices weighted towards low-fat grains, vegetables, fruits, and legumes and limited additional fats, sweets, and high-fat snacks; calorie intake of 1500 kcal per day for women and 1800 kcal per day for men was encouraged.

The Mediterranean diet was a moderate-fat diet rich in vegetables, with reduced red meat, and poultry and fish replacing beef and lamb. Total calories from fat of 35% per day or less was the goal, with most fat calories from olive oil and a handful of nuts. Like the low-fat program, calories were limited to 1500 kcal per day for women, 1800 kcal per day for men.

The low-carbohydrate diet was patterned after the popular Atkins’ program, with 8% participants achieving the ketosis that Dr. Atkins’ advocated as evidence that a fat-burning metabolism was activated, rather than sugar-burning as fuel. For the 2-month “induction phase,” 20 grams of carbohydrates per day was set as the goal, followed by 120 grams per day once the weight goal was achieved. Unlike the other two diets, calories, protein and fat were unlimited.

Weight loss, lipids, inflammation

You can see from the weight loss graph that the low-carb approach exerted the most dramatic initial weight loss. Interestingly, much of the weight-loss benefit was lost as the carbohydrate intake increased, by study design, back to 120 mg per day. However, the other two diet approaches showed similar phenomena of “giving back” some of the initial weight loss.

The low-carbohydrate diet exerted the greatest change in cholesterol, or lipid, panels: increased HDL 8.4 mg/dl vs. 6.3 mg/dl on low-fat; the triglyceride response was the most dramatic, with a reduction of 23.7 mg/dl vs. 3.7 mg/dl on low-fat. Interestingly, the LDL cholesterol-reducing effect of all three diets was modest, with the most reduction achieved by the Mediteranean diet.

The inflammatory measure, C-reactive protein (CRP), was reduced most effectively by the low-carb and Mediterranean diets, least by the low-fat diet. HbA1c, a measure of long-term blood sugar, dropped significantly more on the low-carb diet.

When the final dietary composition was examined, interestingly, there really were only modest differences among the three diets, with 8% less calories from carbs, 8% greater calories from fat, comparing low-carb to low-fat, with Mediterranean intermediate.

Taken at face value, this useful exercise quite clearly shows that, from the perspective of weight loss and correction of metabolic parameters like triglycerides, HDL,CRP, and blood sugar, low-carbohydrate wins hands down, with Mediterranean diet a close second.

It also suggests that a return to a carbohydrate intake of 120 mg/day allows a partial return of initial weight lost, as well as deterioration of metabolic parameters after the initial positive changes.

Although the study has already received some criticism for such potential flaws as the modest number of Atkins’ followers achieving ketosis (8%), suggesting lax adherence, and the reintroduction of the 120 mg/day carbohydrate advice, I can suspect that these may have been compromises drawn to satisfy some Institutional Review Board. (Whenever a study is going to be conducted involving human subjects, a study needs to pass through the review of an Institutional Review Board, or IRB. IRB’s, while charged to protect human subjects from experimental abuses, also tend to be painfully conservative and will block a study or demand changes even if they are not dangerous, but just veer too far off the mainstream.)

However, several unanswered questions remain:

1) How would the diets have compared if the carbohydrate restriction were continued for a longer period, or even indefinitely? (The divergences would likely have been dramatic.)
2) Will low-carb exert the same cardiovascular event reduction that the Mediterranean approach has shown in the Lyon study and others?
3) Are there effects on health outside of the measures followed that differ among the three diets, such as cancer? (I doubt it, especially given the modest real differences over time. But this will be the objection raised by various "official" organizations.)

I would further propose that:

Low-fat diets are dead

The AHA will cling to their version of low-fat diet, based on difficulty in changing course for any large, consensus-driven organization, not to mention the substantial ($100’s of millions) revenues derived from endorsing low-fat manufactured products. The AHA will also point to the lack of difference in LDL cholesterol among the three, since they cannot get beyond the fact that there’s more to coronary risk—a lot more—than LDL.

Off-the-shelf diets achieve off-the-shelf results

If you just need a T-shirt, a medium might fit fine. But if you’d like a nicely fitting suit or dress, then tailoring to your individual proportions is needed. When aiming towards maximizing benefits on lipoproteins and coronary risk, none of these diets achieve the kinds of changes we often need for coronary plaque reversal, as in the Track Your Plaque program. That requires making dietary changes that exert maximal effects on lipoprotein patterns.

Do I sell heart scans?

18. July 2008 William Davis (12)

I came across a criticism of the Track Your Plaque program recently that suggested that it was nothing more than a program to sell CT heart scans.

Huh?

I suppose if you say that the Track Your Plaque program is nothing more than a way to sell heart disease prevention, omega-3 fatty acids from fish oil, vitamin D, better nutrition, and better identification of causes of heart disease . . . well, I believe that would be true.

But is the program a "front" to sell heart scans?

No, it is not, nor has it ever been.

I've heard about these peculiar suspicions about the program before. Though I've never taken them seriously, let me clear up any lingering uncertainty:

--I have no relationship with any heart scan center, scanning facility, or hospital other than to interpret heart scans.

I do not own a scanner, I have no financial interest in a scanner or scanning center, nor have I ever had any interest. I also have no plans to do so in the future. Let business people in the imaging business do that. I want no part of it. I have seen what these people go through and, frankly, I want no part of it, nor do I want the appearance that I am advocating scans to make money. I'm accused of trying to make money from scans even when I do not have any financial interest!

--I do not sell heart scans or imaging packages, nor have I ever done so.

You can't buy a scan through Track Your Plaque, The Heart Scan Blog, or through me. To me, heart scans are simply a measuring tool to identify the extent of coronary plaque, as well as a tracking tool to follow its course. Without it, there would be no Track Your Plaque. But there is also no alternative. The closest alternative would be carotid intimal-medial thickness, a technique, while useful, is a distant second choice to indirectly gauge coronary plaque by examining the thickness of the carotid lining (not carotid plaque). Perhaps in 10 years, a better measure to gauge and track coronary plaque will emerge that has superior aspects over CT heart scanning. If reasonable, safe, accessible, and quantitative, then Track Your Plaque may adopt that technology as its measuring tool.

Track Your Plaque is not about heart scanning; Track Your Plaque is about measuring and tracking plaque that, in 2008, is still best accomplished with CT heart scans.

--I make loads of money from heart scans and Track Your Plaque.

Yeah, right.

Track Your Plaque is a volunteer venture for my team; none of us get paid a penny for doing all we do, including me. We charge a membership fee on the website (somewhere around $6-7 a month) to pay our expenses, such as code writing for our proprietary software (much of it remains under development), printing costs, modest legal costs, the costs of doing business (e.g., accountant). Despite the fact that Track Your Plaque and the Heart Scan Blog occupies a substantial part of the day of the Track Your Plaque team, none of us are reimbursed for our time. I do believe, however, that this concept is so enormously powerful that it will, someday, pay us all enough to allow us to devote more time and effort to it.

Personally, I can't wait to devote more time and effort to this concept that is simple, logical, and effective. More research is needed, more development is needed, more discussion is needed. Right now, it is all accomplished outside of our busy schedules, including my full-time cardiology practice. I continue to have 7 am procedures, middle-of-the-night calls, weekend hospital rounds and emergencies (though virtually none of these are the patients involved in prevention, but the "other" people: atrial fibrillation, elderly heart failure patients, rhythm disorders, cardiomyopathies, pulmonary hypertension, peripheral vascular disease, the non-compliant).

--The book, Track Your Plaque, is a gimmick to sell you a heart scan.

No, it's a program that relies on this technology. But there's no special deal, no discounts, no steering to heart scan centers that I have a special arrangement with. No such thing exists, nor has there ever been such an arrangement.

I've heard it all. Early on, when I was helping my friend, Steve Burlingame and his wife, Nancy, set up Milwaukee Heart Scan, I helped by providing medical oversite, education of physicians and public, and interpreting heart scans. After all, in the "early days," nobody knew anything about heart scans. It was a long, hard climb against ignorance, habit, entrenched thinking, stubbornness, and stupidity. I've been paid next to nothing for all this. I told Steve long ago that, given the extraordinary expenses of maintaining an independent scanning center, that he should first pay his expenses, pay his technologists, receptionists, and nurse, pay himself, then pay me for reading scans if he had any money left over. Most of the time, Steve had nothing left over and I was paid nothing.

So, while some of my colleagues were assuming that I was rolling in money from "promoting" heart scans, the reality was that I was doing nearly everything for free. (It certainly wasn't the high life I was living; I don't drive a Mercedes, take fancy vacations, none of that. In fact, I work about 51 weeks a year.)

Why do I do this if it doesn't yield a big flow of money? Because I believe in it as a superior path to the conventional. If I were simply interested in making more money--I wouldn't do it. I would simply do what all my cardiology colleagues are doing: more heart catheterizations, more angioplasties and stents, learning how to do carotid stents, iliac stents, peripheral angioplasty, renal stents, acquiring the skills to put in defibrillators, new device insertion like umbrellas in the interatrial septum, etc. There's plenty more money in that. It's also not that hard. I know, because that is my background: high-risk cardiac interventions. That's what I was trained to do, that's what I did from a number years, until I started to see that this was nothing more than "putting out fires" in people who became increasingly ill and reliant on bail-out procedures. It makes lots of money, but it is also fundamentally wrong.

So, no, I do not sell heart scans, nor is the Track Your Plaque program or The Heart Scan Blog meant to promote heart scans except as a tool for tracking this disease.

That's it, pure and simple.

Plaque is the new cholesterol

17. July 2008 William Davis (3)

Which is more important: cholesterol or coronary plaque?

Ask what Dr. Michael Eades' calls "statinators," and you will likely receive a befuddled look. Or, you might receive comments like "Measuring plaque has never been shown to reduce mortality."

While risk factors for heart disease are important, no doubt (my office practice is about half lipid consultation and complex hyperlipidemia management), for many they have become an end in themselves. In other words, LDL cholesterol in particular dominates thinking so much that it has caused many to exclude the fact that plaque---coronary atherosclerotic plaque---is the disease itself.

Dozens of studies, from the St. Francis Heart Study to the 25,000-participant UCLA registry, to the recently-released MESA database (ethic differences, women, as well as superiority to carotid measures) have repeatedly shown that heart scan scores (coronary artery calcium scores) are superior to conventional risk factors (usually via the Framingham risk score) for predicting future heart attack and other events. And the differences are not minor incremental differences. The predictive power of plaque measurement via heart scanning is multiples better: 4 times, 10 times, 20 times or more in various subgroups.

Much of what we do in medicine is not based on long-term studies of outcome, pitting some diagnostic measure or treatment against placebo. It is already standard practice to measure plaque via heart catheterization, crudely via stress testing, and increasingly popular CT coronary angiography. None of these methods have been subjected to studies comparing testing vs. not testing in a large population, followed by some program of prevention to assess differences in mortality, heart attack, and other events.

Why should heart scan be held to such a standard?

Dr. Scott Grundy, lipid guru and one of the experts who sat on the Adult Treatment Panel-II for lipid management guidelines, recently stated [emphasis added]:

"Imaging has at least 3 virtues. It individualizes risk assessment beyond use of age, which is a less reliable surrogate for atherosclerosis burden; it provides an integrated assessment of the lifetime exposure to risk factors; and it identifies individuals who are susceptible to developing atherosclerosis beyond established risk factors. Also of importance, in the absence of detectable atherosclerosis, short-term risk appears to be very low."

Well said, and from a vocal statinator, to boot.

Sadly, Dr. Grundy goes on to say how plaque imaging can serve to better determine who will benefit from statin drug use.

Of course, you and I know that there is far more to reduction of cardiovascular risk applied to a framework of serial plaque quantification ("tracking plaque"!) than statin drugs. I doubt that a man as intelligent as Dr. Grundy truly believes this. I suspect that he is simply stating what he knows what will be published without resistance in the standard medical literature, trying to achieve a modest incremental success just by raising consciousness about heart scanning and plaque imaging: first things first.

Maybe next will be a plaque-tracking, or even a plaque-reducing, mainstream conversation, just like the one we've been conducting for the past four years.

Track Your Plaque success story blows it

17. July 2008 William Davis (3)

Joe was a Track Your Plaque Success Story. With a starting heart scan score of 278, he dropped it 12 months later to 264, a 5% reduction. Though not a huge reduction, Joe's risk for a heart attack or other coronary event was virtually zero. I was very proud of Joe.

Among the culprit lipoprotein patterns that caused Joe's plaque was lipoprotein(a), or Lp(a). Niacin was therefore crucial to his program. It was among the principal reasons he dropped his heart scan score and reduced his risk for heart attack so dramatically.

Since he retired, Joe has been freewheeling around the country, traveling and having a great time. He consequently stopped thinking about his heart disease and Lp(a). He also tired of the occasional hot flushes he'd experienced with niacin. Though the flushes were promptly aborted by drinking two glasses of water, he simply didn't want to be bothered.

So when Joe saw this interesting and tantalizing "flush-free niacin" on the store shelf, he grabbed it.

Joe came back to the office. His blood pressure was 190/94, so high that he was having occasional chest pains from it (which can happen when something called "left ventricular diastolic dysfunction" develops from hypertension). His lipoprotein patterns were terrible, including a big upward jump in Lp(a) and drop in HDL. So I asked him to have another heart scan right away: Score 371, a 40% increase. In other words, his program went down the toilet.

Why?

Simple: Flush-free niacin. I've said it before (No flush = No effect and No flush niacin kills) and I'll say it again:

Flush-free or No-flush niacin is a complete, unadulterated, completely ineffective SCAM.

Flush-free or no-flush niacin is not a substitute for niacin. Joe is yet another example of how dangerous this scam can be. It turned one of our great success stories into a failure.

Please, please, please do not fall for this misleading and potentially dangerous scam product. While the product itself is not intrinsically dangerous, it denies you the benefits of the real thing: niacin.

Thankfully, the mistake in Joe's program was caught before a heart attack or other catastrophe. He did manage to pass a stress test, though with a flagrantly out-of-control blood pressure response. We'll get him back on track--but with niacin, the real thing.