ic routine, e.g., green banana on Monday, inulin on Tuesday, PGX (below) on Wednesday, etc. Beyond providing convenience, these products may introduce an added level of diversity, as well.

Among the preparations available to us that can be used as prebiotic fibers:

PGX

While it is billed as a weight management and blood sugar-reducing product, the naturally occurring fiber--α-D-glucurono-α-D-manno-β-D-manno- β-D-gluco, α-L-gulurono-β-D mannurono, β-D-gluco-β- D-mannan--in PGX also exerts prebiotic effects (evidenced by increased fecal butyrate, the beneficial end-product of bacterial metabolism). PGX is available as capsules or granules. It also seems to exert prebiotic effects at lower doses than other prebiotic fibers. While I usually advise reaching 20 grams per day of fiber, PGX appears to exert substantial effects at a daily dose of half that quantity. As with all prebiotic fibers, it is best to build up slowly over weeks, e.g., start at 1.5 grams twice per day. It is also best taken in two or three divided doses. (Avoid the PGX bars, as they are too carb-rich for those of us trying to achieve ideal metaobolic health.)

Prebiotin

A combination of inulin and FOS available as powders and in portable Stick Pacs (2 gram and 4 gram packs). This preparation is quite costly, however, given the generally low cost of purchasing chicory inulin and FOS separately.

Acacia

Acacia fiber is another form of prebiotic fiber.  RenewLife and NOW are two reputable brands.

Isomalto-oligosaccharides

This fiber is used in Quest bars and in Paleo Protein Bars. With Quest bars, choose the flavors without sucralose, since it has been associated with undesirable changes in bowel flora.

There you go. It means that there are fewer and fewer reasons to not purposefully cultivate healthy bowel flora and obtain all the wonderful health benefits of doing so, from reduced blood pressure, to reduced triglycerides, to deeper sleep.

Disclaimer: I am not compensated in any way by discussing these products.

How Not To Have An Autoimmune Condition


Autoimmune conditions are becoming increasingly common. Estimates vary, but it appears that at least 8-9% of the population in North America and Western Europe have one of these conditions, with The American Autoimmune Related Diseases Association estimating that it’s even higher at 14% of the population.

The 200 or so autoimmune diseases that afflict modern people are conditions that involve an abnormal immune response directed against one or more organs of the body. If the misguided attack is against the thyroid gland, it can result in Hashimoto’s thyroiditis. If it is directed against pancreatic beta cells that produce insulin, it can result in type 1 diabetes or latent autoimmune diabetes of adults (LADA). If it involves tissue encasing joints (synovium) like the fingers or wrists, it can result in rheumatoid arthritis. It if involves the liver, it can result in autoimmune hepatitis, and so on. Nearly every organ of the body can be the target of such a misguided immune response.

While it requires a genetic predisposition towards autoimmunity that we have no control over (e.g., the HLA-B27 gene for ankylosing spondylitis), there are numerous environmental triggers of these diseases that we can do something about. Identifying and correcting these factors stacks the odds in your favor of reducing autoimmune inflammation, swelling, pain, organ dysfunction, and can even reverse an autoimmune condition altogether.

Among the most important factors to correct in order to minimize or reverse autoimmunity are:


Wheat and grain elimination

If you are reading this, you likely already know that the gliadin protein of wheat and related proteins in other grains (especially the secalin of rye, the hordein of barley, zein of corn, perhaps the avenin of oats) initiate the intestinal “leakiness” that begins the autoimmune process, an effect that occurs in over 90% of people who consume wheat and grains. The flood of foreign peptides/proteins, bacterial lipopolysaccharide, and grain proteins themselves cause immune responses to be launched against these foreign factors. If, for instance, an autoimmune response is triggered against wheat gliadin, the same antibodies can be aimed at the synapsin protein of the central nervous system/brain, resulting in dementia or cerebellar ataxia (destruction of the cerebellum resulting in incoordination and loss of bladder and bowel control). Wheat and grain elimination is by far the most important item on this list to reverse autoimmunity.

Correct vitamin D deficiency

It is clear that, across a spectrum of autoimmune diseases, vitamin D deficiency serves a permissive, not necessarily causative, role in allowing an autoimmune process to proceed. It is clear, for instance, that autoimmune conditions such as type 1 diabetes in children, rheumatoid arthritis, and Hashimoto’s thyroiditis are more common in those with low vitamin D status, much less common in those with higher vitamin D levels. For this and other reasons, I aim to achieve a blood level of 25-hydroxy vitamin D level of 60-70 ng/ml, a level that usually requires around 4000-8000 units per day of D3 (cholecalciferol) in gelcap or liquid form (never tablet due to poor or erratic absorption). In view of the serious nature of autoimmune diseases, it is well worth tracking occasional blood levels.

Supplement omega-3 fatty acids

While omega-3 fatty acids, EPA and DHA, from fish oil have proven only modestly helpful by themselves, when cast onto the background of wheat/grain elimination and vitamin D, omega-3 fatty acids compound anti-inflammatory benefits, such as those exerted via cyclooxygenase-2. This requires a daily EPA + DHA dose of around 3600 mg per day, divided in two. Don’t confuse EPA and DHA omega-3s with linolenic acid, another form of omega-3 obtained from meats, flaxseed, chia, and walnuts that does not not yield the same benefits. Nor can you use krill oil with its relatively trivial content of omega-3s.

Eliminate dairy

This is true in North America and most of Western Europe, less true in New Zealand and Australia. Autoimmunity can be triggered by the casein beta A1 form of casein widely expressed in dairy products, but not by casein beta A2 and other forms. Because it is so prevalent in North America and Western Europe, the most confident way to avoid this immunogenic form of casein is to avoid dairy altogether. You might be able to consume cheese, given the fermentation process that alters proteins and sugar, but that has not been fully explored.

Cultivate healthy bowel flora

People with autoimmune conditions have massively screwed up bowel flora with reduced species diversity and dominance of unhealthy species. We restore a healthier anti-inflammatory panel of bacterial species by “seeding” the colon with high-potency probiotics, then nourishing them with prebiotic fibers/resistant starches, a collection of strategies summarized in the Cureality Digestive Health discussions. People sometimes view bowel flora management as optional, just “fluff”–it is anything but. Properly managing bowel flora can be a make-it-or-break-it advantage; don’t neglect it.

There you go: a basic list to get started on if your interest is to begin a process of unraveling the processes of autoimmunity. In some conditions, such as rheumatoid arthritis and polymyalgia rheumatica, full recovery is possible. In other conditions, such as Hashimoto’s thyroiditis and the pancreatic beta cell destruction leading to type 1 diabetes, reversing the autoimmune inflammation does not restore organ function: hypothyroidism results after thyroiditis quiets down and type 1 diabetes and need for insulin persists after pancreatic beta cell damage. But note that the most powerful risk factor for an autoimmune disease is another autoimmune disease–this is why so many people have more than one autoimmune condition. People with Hashimoto’s, for instance, can develop rheumatoid arthritis or psoriasis. So the above menu is still worth following even if you cannot hope for full organ recovery

Five Powerful Ways to Reduce Blood Sugar

Left to conventional advice on diet and you will, more than likely, succumb to type 2 diabetes sooner or later. Follow your doctor’s advice to cut fat and eat more “healthy whole grains” and oral diabetes medication and insulin are almost certainly in your future. Despite this, had this scenario played out, you would be accused of laziness and gluttony, a weak specimen of human being who just gave into excess.

If you turn elsewhere for advice, however, and ignore the awful advice from “official” sources with cozy relationships with Big Pharma, you can reduce blood sugars sufficient to never become diabetic or to reverse an established diagnosis, and you can create a powerful collection of strategies that handily trump the worthless advice being passed off by the USDA, American Diabetes Association, the American Heart Association, or the Academy of Nutrition and Dietetics.

Among the most powerful and effective strategies to reduce blood sugar:

1) Eat no wheat nor grains

Recall that amylopectin A, the complex carbohydrate of grains, is highly digestible, unlike most of the other components of the seeds of grasses AKA “grains,” subject to digestion by the enzyme, amylase, in saliva and stomach. This explains why, ounce for ounce, grains raise blood sugar higher than table sugar. Eat no grains = remove the exceptional glycemic potential of amylopectin A.

2) Add no sugars, avoid high-fructose corn syrup

This should be pretty obvious, but note that the majority of processed foods contain sweeteners such as sucrose or high-fructose corn syrup, tailored to please the increased desire for sweetness among grain-consuming people. While fructose does not raise blood sugar acutely, it does so in delayed fashion, along with triggering other metabolic distortions such as increased triglycerides and fatty liver.

3) Vitamin D

Because vitamin D restores the body’s normal responsiveness to insulin, getting vitamin D right helps reduce blood sugar naturally while providing a range of other health benefits.

4) Restore bowel flora

As cultivation of several Lactobacillus and Bifidobacteria species in bowel flora yields fatty acids that restore insulin responsiveness, this leads to reductions in blood sugar over time. Minus the bowel flora-disrupting effects of grains and sugars, a purposeful program of bowel flora restoration is required (discussed at length in the Cureality Digestive Health section.)

5) Exercise

Blood sugar is reduced during and immediately following exercise, with the effect continuing for many hours afterwards, even into the next day.

Note that, aside from exercise, none of these powerful strategies are advocated by the American Diabetes Association or any other “official” agency purporting to provide dietary advice. As is happening more and more often as the tide of health information rises and is accessible to all, the best advice on health does not come from such agencies nor from your doctor but from your efforts to better understand the truths in health. This is our core mission in Cureality. A nice side benefit: information from Cureality is not accompanied by advertisements from Merck, Pfizer, Kelloggs, Kraft, or Cadbury Schweppes.

Cureality App Review: Breathe Sync



Biofeedback is a wonderful, natural way to gain control over multiple physiological phenomena, a means of tapping into your body’s internal resources. You can, for instance, use biofeedback to reduce anxiety, heart rate, and blood pressure, and achieve a sense of well-being that does not involve drugs, side-effects, or even much cost.

Biofeedback simply means that you are tracking some observable physiologic phenomenon—heart rate, skin temperature, blood pressure—and trying to consciously access control over it. One very successful method is that of bringing the beat-to-beat variation in heart rate into synchrony with the respiratory cycle. In day-to-day life, the heart beat is usually completely out of sync with respiration. Bring it into synchrony and interesting things happen: you experience a feeling of peace and calm, while many healthy phenomena develop.

A company called HeartMath has applied this principle through their personal computer-driven device that plugs into the USB port of your computer and monitors your heart rate with a device clipped on your earlobe. You then regulate breathing and follow the instructions provided and feedback is obtained on whether you are achieving synchrony, or what they call “coherence.” As the user becomes more effective in achieving coherence over time, positive physiological and emotional effects develop. HeartMath has been shown, for instance, to reduce systolic and diastolic blood pressure, morning cortisol levels (a stress hormone), and helps people deal with chronic pain. Downside of the HeartMath process: a $249 price tag for the earlobe-USB device.

But this is the age of emerging smartphone apps, including those applied to health. Smartphone apps are perfect for health monitoring. They are especially changing how we engage in biofeedback. An app called Breathe Sync is available that tracks heart rate using the camera’s flash on the phone. By tracking heart rate and providing visual instruction on breathing pattern, the program generates a Wellness Quotient, WQ, similar to HeartMath’s coherence scoring system. Difference: Breathe Sync is portable and a heck of a lot less costly. I paid $9.99, more than I’ve paid for any other mainstream smartphone application, but a bargain compared to the HeartMath device cost.

One glitch is that you need to not be running any other programs in the background, such as your GPS, else you will have pauses in the Breathe Sync program, negating the value of your WQ. Beyond this, the app functions reliably and can help you achieve the health goals of biofeedback with so much less hassle and greater effectiveness than the older methods.

If you are looking for a biofeedback system that provides advantage in gaining control over metabolic health, while also providing a wonderful method of relaxation, Breathe Sync, I believe, is the go-to app right now.

How did Cureality get its start?




In the Cureality program, we embrace information and strategies that empower you in health without drugs, without hospitals, without procedures. We convert your doctor from director of healthcare to your assistant in health. He or she is there when you need help, but you largely direct your own health future.

How did we gain the know-how, information, tools, even chutzpah to take on such an ambitious project?


It started around 10 years ago with the awkwardly named Track Your Plaque program. In fact, some of the current followers of the Cureality program are former Track Your Plaque members, having learned of the wonderful list of strategies that can be adopted to gain better control over, even reverse, coronary atherosclerotic plaque and risk for heart attack. They also learned that something special happens when you engage with other people with similar interests, all sharing ideas, insights, and resources to get the self-directed health job done. Over time, what started out as simply a source of better information for coronary health evolved into a self-directed coronary disease management program. We never set out to create something as wildly ambitious as a do-it-yourself-at-home coronary disease risk management program, but that is how it inadvertently turned out.

How we went from Information Provider to Health Empowerment Program

So we never intended to take on something so seemingly impossible as managing coronary risk on your own. But, because we armed people with such empowering, profound insights into better ways to manage their heart disease risk beyond “don’t smoke, cut saturated fat, be active, and take a statin drug”—the typical advice offered by doctors—they returned after an interaction with their doctors disappointed: doctors often declared such strategies unnecessary, or the doctor didn’t understand them—even when there were clear-cut clinical data already available to support their use. In other words, the patients—everyday people, not experts—knew more than their doctors. 

This flip-flop in the balance of knowledge made for some very interesting stories, like “Harold” (not his real name) who, having survived a heart attack and received a stent, was told by his doctor to cut his fat intake, eat more whole grains, exercise, take aspirin and a beta blocker drug, and reduce his cholesterol values with a statin drug. Upon learning all the additional information from the Track Your Plaque program, Harold returned to his doctor and asked “I’m not so ready to just go along with this idea of ‘reducing cholesterol’ to address heart disease risk. Because my goal is to gain as much control over coronary disease as possible, maybe even reverse it, I’d like to address some additional issues that I believe may be important. I’d like to have my advanced lipoproteins drawn to measure the proportion of small LDL particles I have, whether I have lipoprotein(a), an omega-3 fatty acid index and 25-hydroxy vitamin D level, and a thyroid assessment. Oh, and I believe I should also have an assessment of my inflammation status, perhaps a c-reactive protein and phospholipase A2, and my blood sugar status measured with a fasting glucose, insulin, and hemoglobin A1c.” Harold’s doctor was dumbfounded and speechless. Rather than reveal his ignorance, his doctor advised Harold that none of that was necessary, sending him on his way and telling him that he was fine.

But this left Harold with a sour taste in his mouth, having engaged in many online discussions with people who had followed conventional advice that resulted in more heart attack, more heart procedures—the conventional answers simply did not work. He also discussed his situation with people who had successfully obtained the additional information he sought, added it to their program and enjoyed dramatically improved health, including freedom from more heart attacks, heart symptoms, and heart procedures, as well as improved overall health. So Harold found an easy way to obtain the testing on his own. Within a couple of weeks, he returned to his online community and shared all his information. Within moments, he was provided useful discussion to help him understand the values, all leading to changes in nutrition, nutritional supplement choices, how and where to get the simple tools necessary, such as iodine and vitamin D supplements. He even entered his data, choosing which values he was willing to share with others, which remained private, allowing him to compare his own follow-up values several months later. Engaged in this process, self-directed but collaborative, he witnessed marked transformations in his health. Not only did he never again—over several years—ever re-develop heart symptoms nor require any more trips back to the cath lab, he lost weight, reversed a pre-diabetic sugar profile, improved his cholesterol values without drugs, got rid of the acid reflux symptoms he endured for many years, dropped his blood pressure to normal, enjoyed better mood, energy, and sleep. Slender, healthier, all accomplished without his doctor. 

Harold returned to his doctor for a routine follow-up. Slender, energetic, without complaints, on no drugs except the aspirin for his stent, the basic laboratory assessment his doctor ordered in front of him, his doctor admitted,” Well, I don’t know how you’re doing it, but these values look like a 20-year old substituted his blood for yours. They’re unbelievable. What drugs are you taking to do this?” “No drugs,” Harold replied, “I’m following a program to reverse heart disease, but it means doing some things that are different from conventional solutions.” His doctor closed their meeting with the signature response of doctors nationwide: “Well, I don’t understand what you are doing, but just keep doing it.”

Yes, Harold knew more about how to control heart disease than his doctor, more than his cardiologist. The cardiologist knew how to insert a stent or defibrillator. But deliver information that empowered Harold in all aspects of health from head to toe, while also dramatically reducing, perhaps eliminating, his coronary disease risk? As you now know, that is not what conventional healthcare does, nor is it interested in doing so, as it would relinquish control and threaten to cut off this hugely profitable revenue stream that drives “healthcare.”

Having managed to inadvertently create a self-directed coronary risk management program with such spectacular results and in probably one of the most difficult areas of all—heart disease—it became clear that a similar approach could be even more easily applied to many other areas of health, such as weight loss, bone health, cholesterol and blood pressure issues, diabetes and pre-diabetes, hormonal health, autoimmune conditions, and others. You can do it when empowered by safe, effective information, and supported by a community of sharing and collaboration. We don’t fire our doctors; they are there when we need them when, for instance, we get injured or catch pneumonia, or as an occasional resource. But doctors should no longer be able to get away with neglect, misinformation, or blindly directing you to the next revenue-generating procedure because you are empowered by the information and support you receive in Cureality.

As we get more effective in delivering this information and new tools to you, just imagine what we can accomplish in this new age of information and self-empowerment. The future for us is bright with ambitions for better interactive tools with Cureality expert staff, better ways to crowd source health answers, provide more engaging community conversation, all while the health insights that help accomplish our self-directed health goals get better and better. Each person that joins Cureality helps make this service more effective because your wisdom, insights, and experience are added to the collective knowledge. We are more powerful together than we are as individuals.

If you are already a Cureality Member, please add your comments and questions to the growing conversation. If you are not a Member, consider joining our discussions, as each new voice gets us closer and closer to better answers to take back control over health.

Power in Numbers



In his book, The Wisdom of Crowds, author James Surowiecki begins with the story of an ox judging competition in which 800 people—not ox experts nor breeders, just ordinary people attending a county fair—were asked to guess the weight of the ox. The competition was conducted by a scientist, Francis Galton, who held a low opinion of the intelligence of the average person, remarking that “the stupidity and wrong-headedness of many men and women being so great as to be scarcely credible.” He hoped to prove, by examining the various guesses, that the average person had no idea of how to judge the real answer. After all participants casted their written votes, Galton tallied up the total and averaged the result: 1,197 pounds—just one pound off from the real weight of 1,198 pounds. Few individuals actually guessed the correct weight themselves but, when the opinions of many were combined, the result was near-perfect.

Crowds can also be a source of irrational behavior, panic, and stampede. Witness any modern football or soccer game, for instance, in which fights break out over an issue as minor as a disputed call or a heckle. Or go back through history to the countless events when mass hysteria ruled, such as the Salem Witch Trials or Orson Welles’ War of the Worlds radio broadcast.

Let’s put aside examples of mass emotional chaos of the sort that causes crowds to stampede store doors on Black Friday. Let’s focus instead on conscious, considered, thoughtful opinions. We all accept that there are as many opinions on issues as there are people, not uncommonly with widely divergent views. But can we, as Galton’s famous experiment did, combine the opinions of many and come away with some fruitful insight—the correct answer? Just as the people participating in Galton’s experiment were not experts, so Cureality participants—a crowd-sourced collection of opinions—are not experts. If we were to poll everyone to identify their area of expertise or experience, it would likely include finance, the retail industry, raising children, or teaching—but not health. Yes, we have experts curating the direction of content, but we also crowd-source collective opinion.

Right now, Cureality is based on existing science, the philosophy of self-directed health, combined with guidance and community to help the participant along in the sometimes complex world of health questions. But as our processes and procedures improve, can we—like Galton’s ox weight guessers—come away with coalescent wisdom, answers to our health questions, near-perfect solutions to health conditions that have eluded the “experts” for centuries?

I think that we can. No, I know that we can. We enter a new age in information and harness the power of the crowd-sourcing of solutions, even when no single individual has the complete answer herself.

What is Cureality all about?


“Looking over your medical record, Nancy, I’m a bit concerned about your risk for osteoporosis and hip fracture. It looks like your mom had a hip fracture at age 67. Is that right? ”

“Yes, she did,” Nancy responded. “And her life was never quite the same for the 15 years she lived after that.

“You’re 53 year old. Bone thinning develops over many years. Let’s get you scheduled for a bone scan.”

Two weeks later:

“Your z-score is 1.5, Nancy. This means you’ve got a mild form of osteoporosis called ‘osteopenia.’ Here: This is a prescription for alendronate, what used to be called Fosamax.”

“Aren’t there side-effects with that drug? A friend of mine said that her mom had a leg fracture from it.”

“Well, yes. All prescription drugs have potential side-effects. They’re rare, but they can happen and we can’t predict it. Besides leg fracture, there’s something called jaw osteonecrosis in which the jawbone dies and has to be surgically replaced. But would you rather run the risk of a hip fracture?”

“Before we jump to drugs, aren’t there natural things I could do first?”

(Big sigh.) “You can take calcium, but that only helps a bit. You’ve got to make a choice: Take the drug or risk a hip fracture.”

“I’m going to explore some natural remedies on my own first.”

Nancy’s dialogue with her doctor is fictional but based on similar encounters that occur thousands of times every day nationwide. Identify a problem, prescribe a drug. Natural remedies? “They don’t work.” “I don’t know anything about that.” “None of that is proven.” “I only practice evidence-based medicine.” You’ve probably heard a few of these explanations yourself if you ever question the wisdom of conventional medical care.

Each of Nancy’s fictitious interactions were no more 10 minutes long. If she is like most people, she will have one or two such interactions over the course of a year, unless she develops some acute illness. So she’s got something like 20-30 minutes per year to compress all of her “health” advice into the time allotted. 20-30 minutes per year to discuss bone health, nutrition, blood sugar issues, cholesterol issues, blood pressure, female issues, and all the other facets of health. Perhaps she has developed some chronic gastrointestinal complaints, too, and an odd rash on her elbows, maybe headaches a few times per week that she didn’t have before. Regardless, she’s going to have to make do with those few minutes, likely receiving one or more prescriptions or imaging procedures for each.

Such is the nature of modern healthcare: Provide the minimum interaction, address only a few, perhaps no more than one, problem, then prescribe a drug. This is, more often than not, wrong. Plain wrong. Tragically, awfully, unethically, unnecessarily wrong.

Let’s pick up again with Nancy. Upon learning of her osteopenia and long-term risk for hip fractures of the sort that changed her mom’s life and health irretrievably, Nancy started searching for solutions. Not only did she discover that, yes, there are indeed a number of safe and effective ways to deal with osteopenia. She also learned that such strategies have even been examined in clinical trials, some of the strategies pitted head-to-head with drugs and performed on a par, sometimes better, than prescription drugs. She also found that there are online communities that she could join and discuss her health situation with people all sharing the same health interests. During one such interaction at the start of her effort, when she was still a bit unsure and tentative, a woman she didn’t know but who shared a similar interest in restoring bone health, commented to Nancy, “Don’t sweat it, Nancy. I was in your shoes a little over a year ago. I followed a program for bone health: vitamin D, vitamin K2, magnesium, I made sure that I included leafy green vegetables at least once or twice per day, and I added strength training for a few minutes twice per week. I started with osteoporosis. My most recent bone density test showed that I reversed it completely—it’s entirely normal! So hang in there and be sure to share your questions and concerns with us here.”

THAT is what Cureality is all about. Cureality fills the gap of knowledge in health that is not being provided in a few minute-long medical interaction. Cureality reveals the astounding amount of credible, safe, scientific information that allows you to participate, sometimes take over completely, various aspects of health. You don’t have to fire your doctor; these efforts supplement the information and advice you obtain (or don’t obtain) in the doctor’s office. While critics may sometimes say that this can be dangerous or that misdiagnoses and dangerous treatments might be risked, our experience is the exact opposite: People do better by taking the reins of health themselves, choosing to use the health care system for acute or catastrophic illness—but not necessarily for health.

Our fictional woman, Nancy, returns to her doctor one year later after undergoing a repeat bone scan. The doctor opened her chart, clearly expecting to scold her for her foolhardy and careless attitude. Instead, he was speechless. After a pause, he said, “I don’t know how you did it, but your bone density is now normal, the density of a healthy 30-year old woman. Just continue doing what you’re doing.” He closed the chart and walked out.

Yes: “Just continue what you are doing”—not “Please tell me what you did so that I might learn something new,” or “Where did you learn about such strategies? I knew nothing about this!” Just “do what you’re doing.” Too often, that is the response you get that defines what modern health care has become.

You don’t want that kind of health care. Sure, it’s reassuring to know that the doctor and hospital are there in case you injure yourself or develop pneumonia. But obtain day-to-day health advice of the sort that keeps you slender, keeps blood pressure normal, maintains normal insulin and blood pressure responses, helps keep bowel health ideal, can even be used to reverse conditions such as autoimmune joint pain, diabetes, osteoporosis, or skin rashes, while costing next to nothing and yielding health care benefits for you and your family in multiple areas of health? That is the kind of health care you want.

That’s why we developed Cureality.


William Davis, MD
Author of 
#1 New York Times Bestseller Wheat Belly: Lose the wheat, lose the weight and find your path back to health, The Wheat Belly Cookbook, and Wheat Belly 30-Minute (or Less!) Cookbook published by Rodale, Inc.  
Author, Track Your Plaque: The only heart disease prevention program that shows how the new CT heart scans can be used to detect, track, and control coronary plaque

Omega-3 fatty acids likely NOT associated with prostate cancer

A weakly constructed study was reported recently that purportedly associated higher levels of omega-3 fatty acid blood levels and prostate cancer. See this CBS News report, for instance.

Lipid and omega-3 fat expert, Dr. William Harris, posted this concise critique of the study, exposing some fundamental problems:

First, the reported EPA+DHA level in the plasma phospholipids in this study was 3.62% in the no-cancer control group, 3.66% in the total cancer group, 3.67% in the low grade cancer group, and 3.74% in the high-grade group. These differences between cases and controls are very small and would have no meaning clinically as they are within the normal variation. Based on experiments in our lab, the lowest quartile would correspond to an HS-Omega-3 Index of <3.16% and the highest to an Index of >4.77%). These values are obviously low, and virtually none of the subjects was in “danger” of having an HS-Omega-3 Index of >8%. So to conclude that regular consumption of 2 oily fish meals a week or taking fish oil supplements (both of which would result in an Index above the observed range) would increase risk for prostate cancer is extrapolating beyond the data.

This study did not test the question of whether giving fish oil supplements (or eating more oily fish) increased PC risk; it looked only a blood levels of omega-3 which are determined by intake, other dietary factors, metabolism and genetics.


The authors also failed to present the fuller story taught by the literature. The same team reported in 2010 that the use of fish oil supplements was not associated with any increased risk for prostate cancer. A 2010 meta-analysis of fish consumption and prostate cancer reported a reduction in late stage or fatal cancer among cohort studies, but no overall relationship between prostate cancer and fish intake. Terry et al. in 2001 reported higher fish intake was associated with lower risk for prostate cancer incidence and death, and Leitzmann et al. in 2004 reported similar findings. Higher intakes of canned, preserved fish were reported to be associated with reduced risk for prostate cancer. Epstein et al found that a higher omega-3 fatty acid intake predicted better survival for men who already had prostate cancer, and increased fish intake was associated with a 63% reduction in risk for aggressive prostate cancer in a case-control study by Fradet et al). So there is considerable evidence actually FAVORING an increase in fish intake for prostate cancer risk reduction.

Another piece of the picture is to compare prostate cancer rates in Japan vs the US. Here is a quote from the World Foundation of Urology:


"[Prostate cancer] incidence is really high in North America and Northern Europe (e.g., 63 X 100,000 white men and 102 X 100,000 Afro-Americans in the United States), but very low in Asia (e.g., 10 X 100,000 men in Japan).”

Since the Japanese typically eat about 8x more omega-3 fatty acids than Americans do and their
blood levels are twice as high, you’d think their prostate cancer risk would be much higher...
but the opposite is the case.


Omega-3 fatty acids are physiologically necessary, normalizing multiple metabolic phenomena including augmentation of parasympathetic tone, reductions of postprandial (after-meal) lipoprotein excursions, and endothelial function. It would indeed make no sense that nutrients that are necessary for life and health exert an adverse effect such as prostate cancer at such low blood levels. (Recall that an omega-3 RBC index of 6.0% or greater is associated with reduced potential for sudden cardiac death.)

I personally take 3600 mg per day of EPA + DHA in highly-purified, non-oxidized triglyceride form (Ascenta Nutrasea liquid) that yields an RBC omega-3 index of just over 10%, the level that I believe the overwhelming bulk of data suggest is the ideal level for humans.

Are statins and omega-3s incompatible?

French researcher, Dr. Michel de Lorgeril, has been in the forefront of thinking and research into nutritional issues, including the Mediterranean Diet, the French Paradox, and the role of fat intake in cardiovascular health. In a recent review entitled Recent findings on the health effects of omega-3 fatty acids and statins, and their interactions: do statins inhibit omega-3?, he explores the question of whether statin drugs are, in effect, incompatible with omega-3 fatty acids.

Dr. Lorgeril makes several arguments:

1) Earlier studies, such as GISSI-Prevenzione, demonstrated reduction in cardiovascular events with omega-3 fatty acid supplementation, consistent with the biological and physiological benefits observed in animals, experimental preparations, and epidemiologic observations in free-living populations.

2) More recent studies (and meta-analyses) examining the effects of omega-3 fatty acids have failed to demonstrate cardiovascular benefit showing, at most, non-significant trends towards benefit.

He points out that the more recent studies were conducted post-GISSI and after agencies like the American Heart Association's advised people to consume more fish, which prompted broad increases in omega-3 intake. The populations studied therefore had increased intake of omega-3 fatty acids at the start of the studies, verified by higher levels of omega-3 RBC levels in participants.

In addition, he raises the provocative idea that the benefits of omega-3 fatty acids appear to be confined to those not taking statin agents, as suggested, for instance, in the Alpha Omega Trial. He speculates that the potential for statins to ablate the benefits of omega-3s (and vice versa) might be based on several phenomena:

--Statins increase arachidonic acid content of cell membranes, a potentially inflammatory omega-6 fatty acid that competes with omega-3 fatty acids. (Insulin provocation and greater linoleic acid/omega-6 oils do likewise.)
--Statins induce impaired mitochondrial function, while omega-3s improve mitochondrial function. (Impaired mitochondrial function is evidenced, for instance, by reduced coenzyme Q10 levels, with partial relief from muscle weakness and discomfort by supplementing coenzyme Q10.)
--Statins commonly provoke muscle weakness and discomfort which can, in turn, lead to reduced levels of physical activity and increased resistance to insulin. (Thus the recently reported increases in diabetes with statin drug use.)

Are the physiologic effects of omega-3 fatty acids, present and necessary for health, at odds with the non-physiologic effects of statin drugs?

I fear we don't have sufficient data to come to firm conclusions yet, but my perception is that the case against statins is building. Yes, they have benefits in specific subsets of people (none in others), but the notion that everybody needs a statin drug is, I believe, not only dead wrong, but may have effects that are distinctly negative. And I believe that the arguments in favor of omega-3 fatty acid supplementation, EPA and DHA (and perhaps DPA), make better sense.



DHA: the crucial omega-3

Of the two omega-3 fatty acids that are best explored, EPA and DHA, it is likely DHA that exerts the most blood pressure- and heart rate-reducing effects. Here are the data of Mori et al in which 4000 mg of olive oil, purified EPA only, or purified DHA only were administered over 6 weeks:



□ indicates baseline SBP; ▪, postintervention SBP; ○, baseline DBP; •, postintervention DBP; ⋄, baseline HR; and ♦, postintervention HR.

In this group of 56 overweight men with normal starting blood pressures, only DHA reduced systolic BP by 5.8 mmHg, diastolic by 3.3 mmHg.

While each omega-3 fatty acid has important effects, it may be DHA that has an outsized benefit. So how can you get more DHA? Well, this observation from Schuchardt et al is important:

DHA in the triglyceride and phospholipid forms are 3-fold better absorbed, as compared to the ethyl ester form (compared by area-under-the-curve). In other words, fish oil that has been reconstituted to the naturally-occurring triglyceride form (i.e., the form found in fresh fish) provides 3-fold greater blood levels of DHA than the more common ethyl ester form found in most capsules. (The phospholipid form of DHA found in krill is also well-absorbed, but occurs in such small quantities that it is not a practical means of obtaining omega-3 fatty acids, putting aside the astaxanthin issue.)

So if the superior health effects of DHA are desired in a form that is absorbed, the ideal way to do this is either to eat fish or to supplement fish oil in the triglyceride, not ethyl ester, form. The most common and popular forms of fish oil sold are ethyl esters, including Sam's Club Triple-Strength, Costco, Nature Made, Nature's Bounty, as well as prescription Lovaza. (That's right: prescription fish oil, from this and several other perspectives, is an inferior product.)

What sources of triglyceride fish oil with greater DHA content/absorption are available to us? My favorites are, in this order:

Ascenta NutraSea
CEO and founder, Marc St. Onge, is a friend. Having visited his production facility in Nova Scotia, I was impressed with the meticulous methods of preparation. At every step of the way, every effort was made to limit any potential oxidation, including packaging in a vacuum environment. The Ascenta line of triglyceride fish oils are also richer in DHA content. Their NutraSea High DHA liquid, for instance, contains 500 mg EPA and 1000 mg DHA per teaspoon, a 1:2 EPA:DHA ratio, rather than the more typical 3:2 EPA:DHA ratio of ethyl ester forms.

Pharmax (now Seroyal) also has a fine product with a 1.4:1 EPA:DHA ratio.

Nordic Naturals has a fine liquid triglyceride product, though it is 2:1 EPA:DHA.





No BS weight loss

If there's something out there on the market for weight loss, we've tried it. By we, I mean myself along with many people and patients around me willing to try various new strategies.

Maybe you say: "Well that's not a clinical trial. How can we know that there aren't small effects?"

Who cares about small effects? If a weight loss strategy causes you to lose 1.2 lbs over 3 months--who cares? Sure, it may count towards a slight measure of health in a 230 lb 5 ft 3 inch woman. But it is insufficient to engage that person's interest and keep them on track. That little result, in fact, will discourage interest in weight loss and cause someone to return to previous behaviors.

What I'm talking about is BIG weight loss--20 lbs the first month, 40 lbs over 4 months, 50-60 lbs over 6 months.

Right now, there are only three things that I know of that yield such enormous effects:

1) Elimination of wheat, cornstarch, and sugars

2) Thyroid normalization (I don't mean following what the laboratory says is "normal")

3) Intermittent fasting


Combine all three in various ways and the results are accelerated even more.

Self-directed health is ALREADY here

It can't happen.

People are too stupid/ignorant/lazy or simply don't care.

It is irresponsible. People will misuse, abuse, misdiagnose, fail to recognize all manner of medical conditions.



It's all true. Most of the medical establishment believes it. And it is self-fulfulling: If you believe it, it will happen.

But it's not true for everybody. If readers of this blog, for instance, were to view the conversations we have in our Track Your Plaque Forum, you would immediately recognize that we have a following that is more sophisticated and knowledgeable about coronary heart disease than 90% of cardiologists. That is really something. Perhaps they can't put in a stent or defibrillator, but they understand an enormous amount about this disease we are all trying to control and reverse, sufficient to seize control over much of their own healthcare for this process and related conditons.

Anyway, self-directed health is already here. And it's happening on an incredible scale.

Witness:

--Nutritional supplements--Now a $21 billion (annual revenues) phenomenon, booming sales of nutritional supplements are a powerful testimonial to the enthuasiasm of the public for self-directed health treatments. Sure, there are plenty of junk supplements out there, but there are also many spectacularly effective products. Information, not marketing, will help tell the difference. Over the long-run, the truth will win out.

The 1994 Dietary Supplement Health and Education Act has allowed the definition of “nutritional supplement” to be stretched to the limit. "Nutritional supplements" includes obviously non-nutritional (though still potentially interesting) products like the hormones pregnenolone, dehydroepiandrosterone (DHEA), and melatonin to be sold on the same shelf as vitamin C. There are also amino acids, polysaccharides, minerals and trace minerals, herbal preparations, flavonoids, carotenoids, antioxidants, phytonutrients.

In fact, I believe that the nutritional supplement pipeline is likely to yield far more exciting and effective products than the drug research pipeline! And you will have access to all of it--without your doctor's involvement.

--Self-ordered laboratory testing--In every state except New York and California, an individual can obtain his or her own laboratory testing. New services are appearing to service this consumer segment. As more people become frustrated with the silly gatekeeping function of their primary care physician and as more people gain more control over some of their healthcare dollars through medical savings accounts, flex-spending, and high-deductible health insurance, more are shopping for cost-saving, self-ordered lab testing. Even at-home lab tests are becoming available, such as ZRT Lab tests we make available through Track Your Plaque.

(In California, a doctor's order, or an order from a health professional allowed to prescribe, is still required which, for most people, is just a formality. Just ask your doctor to sign the form with the tests you'd like. Only the most cretinous of physicians will refuse, in which case you should say goodbye. New York is the only state in the U.S. that still dunks women to see if they float, divines the entrails of sacrificial cows, and prohibits lab self-testing.)

--Self-ordered medical imaging--Heart scans, full body scans; ultrasound screening for abdominal aneurysms, carotid disease, osteoporosis such as that offered by LifeLine Screening (who does a great job). There's plenty of room here for entrepreneurial types to develop new services, though there will also be battles to fight with hospitals, radiologists, and others invested in the status quo. But it is happening and it will grow.

(By the way, since I've previously been accused of making bundles of money from medical imaging: I have never--NEVER--owned and do not currently own any medical imaging facility.)


So the question is not "will it happen?" It is already happening. The question is how fast will it grow to include a larger segment of the public? How much more of conventional healthcare can it include? How can we develop better unbiased information sources, untainted by marketing, that guide people through the maze of choices?

Fire your stockbroker, fire your doctor

Is it yet time to fire your doctor?

I advocate a model of self-directed health, a style of healthcare in which individuals have the right to direct his or her own healthcare with only the occasional assistance of a physician or healthcare provider.

Healthcare would not be the first industry that converted to such a self-directed model. Remember travel agents? Only 15 years ago, making travel plans meant calling your travel agent to book your arrangements. This was a flawed system, because they worked on commission, thereby impairing incentive to search for the best prices. You were, in effect, at their mercy.

The investment industry is another such example, though on a larger scale.

Up until the 1980s, individual investment was managed by a stockbroker or other money manager. Stockbrokers, analysts, and investment houses commanded the flow of investment in stocks, options, futures, commodities, etc. Individuals lacked access to the methods and knowledge that allowed them to manage their own portfolios. Individuals had no choice but to engage the services of a professional investor. This was also a flawed system. Like travel agents, stockbrokers worked on commission. We've all heard horror stories in which stockbrokers churned accounts, making thousands of dollars in commissions while their clients' portfolios shrunk.

That has all changed.

Today, the process has largely converted to discount brokers and online services used by individuals trading and managing their own portfolios. Stockbrokers and investment houses continue, of course, but are competing for a shrinking piece of the individual investment market. Independent investors now have access to investment tools that didn’t even exist 20 years ago. Companies like E-Trade and Ameritrade now command annual revenues of approximately $2 billion each.

Travel agents, stockbrokers . . . is healthcare next? Can we convert from the paternalistic, “I’m-the-doctor, you’re the patient” relationship to what in which you self-direct your own healthcare and turn to the healthcare system only in unique situations?

I believe that the same revolution that shook the investment industry in the 1980s will seize healthcare in the future. In fact, the transition to self-directed health will dwarf its investing counterpart. It will ripple more broadly through the fabric of American life. Health is a more complicated “product,” with more complex modes of delivery, and more varied levels of need than the investment industry.

I predict that the emergence of health directed by the individual, just as the emergence of self-directed investment, will dominate in the coming years.

While I hope you've already fired your stockbroker, and I doubt that anyone on the internet still uses a travel agent, I wouldn't yet fire your doctor altogether. But I believe that we are approaching a time in which you should begin to take control over your own health and begin to reduce reliance on doctors, drugs, and hospitals.

Blast small LDL to oblivion

Here's a graphic demonstration of the power of wheat elimination to reduce small LDL particles, now the number one cause for heart disease in the U.S.

Lee had suffered a stroke due to an atherosclerotic plaque in a brain artery. She also had plenty of coronary plaque with a heart scan score of 322.

Lee began with an LDL particle number (the "gold standard" for measuring LDL, far superior to conventional calculated LDL) of 2234 nmol/L. This is exceptionally high, the equivalent of an LDL cholesterol of 223 mg/dl (drop the last digit). Of this 2234 nmol/L, 90% were abnormally small, with 1998 nmol/L of small LDL particles.

Lee eliminated wheat products from her diet, as well as cutting out sugars and cornstarch. Six months later, her results:

LDL particle number: 1082 nmol/L--a 52% reduction from the starting value and equivalent to an LDL of 108 mg/dl. Small LDL: zero--yes, zero.

In other words, 100% of Lee's LDL particles had shifted to the more benign large LDL simply with elimination of these foods---NO statin drug. (In addition to wheat elimination, she was also taking vitamin D and omega-3 fatty acids at our recommended doses.)

While not everybody responds quite so vigorously due to genetic variation, nor does everyone try as hard as Lee did to eliminate the foods that trigger small LDL, her case provides a great illustration of the power of this strategy.

Buy local, get a goiter

The notion of buying food locally--"buy local"--i.e., food produced in your area, state, or region, is catching on.

And for good reason: Not only do you support your local economy, buying locally saves energy, since food doesn't have to be transported from South America or other faraway locations.

But what about those of us in the Midwest, particularly around the Great Lakes basin, i.e., the region previously known as the "goiter belt"? In the early 20th century, up to a third of the residents of this region had enlarged thyroid glands, or goiters, due to iodine deficiency. Lack of iodine causes the thyroid to enlarge, or "hypertrophy," in an effort to more efficiently extract any available iodine in the blood.

Well, there's been a resurgence of iodine deficiency nationwide with 11.3% of the population severely deficient, representing a four-fold increase since the 1970s.

Why an iodine deficiency? Because more people are avoiding iodized salt, the principal source of iodine for Americans since the FDA introduced its voluntary program for iodization of table salt back in 1924. Approximately 90% of the patients I ask now declare that they use very little iodized table salt. While a few take multimineral or multivitamin supplements that contain iodine, the majority do not. The globalization of the food supply--eat global--however, has softened the blow, since we eat tomatoes from Mexico, blueberries from Argentina, lettuce from the Salinas Valley of California.

Now, we have the growing trend to eat local. In the Midwest, it means that the vegetables, fruits, and meats grown locally will also be iodine depleted, since the soil is also iodine-poor, being so far from the sea.

Ironically, two healthy trends--avoiding salt and eating local--will be accounting for a surge in unsightly neck bulges in the Midwest, as well as an increase in thyroid disease.

The lesson: Avoid salt, eat local, but mind your iodine.

Self-directed thyroid management

Is there an at-home test you can do to gauge thyroid status?

Yes. Measure your temperature.

Unlike a snake or alligator that relies on the sun or its surroundings to regulate body temperature, you and I can internally regulate temperature. The hypothalamus-pituitary-thyroid glands are the organs involved in thermoregulation, body temperature regulation. While the system can break down anywhere in the sequence, as well as in other organs (e.g., adrenal), the thyroid is the weak link in the chain.

Thus, temperature assessment can serve as a useful gauge of thyroid adequacy. Unfortunately, temperature measurement as a reflection of thyroid function has not been well explored in clinical studies. It has also been subject to a good deal of unscientific discussions.

How should temperature be measured? The temperature you really desire is between 3 am and 6 am, while still asleep. However, this is difficult to do, since it would require your bed partner to surreptitiously insert a thermometer into some body orifice without disturbing you. A practical solution is to measure temperature first upon arising in the morning, before drinking water, coffee, making the bed, etc.--immediately.

While traditionalists (followers of Dr. Broda Barnes, who first suggested that temperature reflects thyroid function) still advocate axillary (armpit) temperatures, in 2009 it is clear that axillary temperatures are unreliable. Axillary temperatures are inconsistent, vary substantially with the clothing you wear, vary from right to left armpit, ambient temperature, sweat or lack of sweat, and other factors. It also can commonly be 2-3 degrees Fahrenheit below internal ("core") temperature and does not track with internal temperatures through the circadian rhythms of the day (high temperature early evening, lowest temperature 3-6 am).

Rectal, urine, esophageal, tympanic membrane (ear), and forehead are other means to measure body temperature, but are either inconvenient (rectal) or require correction factors to track internal temperature (e.g., forehead and ear). For these reasons, we use oral temperatures. Oral temperatures (on either side of the underside of the tongue) are convenient, track reasonably well with internal temperatures, and are familiar to most people.

Though there are scant data on the distribution of oral temperatures correlated to thyroid function, we find that the often-suggested cutoff of 97.6 degrees Fahrenheit, or 36.4 C, seems to track well with symptoms and thyroid laboratory evaluation (TSH, free T3, and free T4). In other words, oral temp <97.6 F correlates well with symptoms of fatigue, cold hands and feet, mental fogginess, along with high LDL cholesterol, all corrected or improved with thyroid replacement and return of temperature to 97.6 F.

But be careful: There are many factors that can influence oral temperature, including clothing, season, level of fitness, "morningness" (morning people) vs. "nightness" (night owls), relation to menstrual cycle, concurrent medical conditions.

Also, be sure that your thermometer can detect low temperatures. Just because it shows low temperatures of, say 94.0 degrees F, doesn't mean that it can really measure that low. If in doubt, dip your thermometer in cold water for one minute. If an improbable temperature is registered, say, 97.0 F, then you know that your device is incapable of detecting low temps.

A full in-depth Special Report on thermoregulation will be coming soon on the Track Your Plaque website.

Self-directed health: At-home lab testing

I have a prediction.

I predict that more and more healthcare can and will be obtained directly by the individual--without doctors, without hospitals, without the corrupt profit-at-any-costs modus operandi of the pharmaceutical industry. I predict that, given the right tools, Joe or Jane Q. Public will have the choice to manage his or her own health using tools that are directly accessible, tools that include direct-to-consumer medical imaging (CT scans, ultrasound, MRI, etc.), nutritional supplements (a loosely-defined term, to our advantage), and direct-to-consumer laboratory testing.

Done responsibly, self-directed healthcare is superior to healthcare from your doctor. While no one expects you to remove your own gallbladder, you can manage cholesterol, blood sugar issues, vitamin D, low thyroid, and others--better than your doctor.

As everyone becomes more comfortable with the notion of self-directed health, you will see new services appear that help individuals manage their health. You will see prices for direct-to-consumer medical imaging and lab testing drop due to competition, something that doesn't happen in current insurance-based healthcare delivery. People are being exposed to larger deductibles and/or draw money from a medical savings account and will seek more cost advantages. Such direct-to-consumer competitive pricing will meet those needs. Overall, the presently unsustainable cost of healthcare will decline.

To help accelerate the shift of human healthcare away from conventional paths and divert it towards the individual, we have launched a panel of direct-to-consumer at-home laboratory tests that we are making available on the Track Your Plaque website.

On your own (except in California, which requires a doctor's order or prescription; and NY, the only state in the nation that prohibits entirely), you can now test, in the comfort of your own home with no laboratory blood draw required, parameters including:

--Thyroid tests--Free T3, free T4, TSH
--Lipids
--C-reactive protein
--Vitamin D
--Testosterone
--Progesterone

and others.

As the technology improves, more tests will become available for testing at home. (Lipoproteins are not yet available, but will probably be available within the next few years. That would be an enormous boon to those of us interested in supercharged heart disease prevention and reversal.)

Anyone interested in our at-home testing can just go to the Track Your Plaque lab test Marketplace.

When I first began the Track Your Plaque program around 8 years ago, I saw it as a way for people to learn how to control or reverse coronary atherosclerotic plaque, and I'd hoped that physicians would begin to see the light and become patient advocates in this process. But I have lost hope that most of my colleagues are interested in becoming your advocate in health. They are too locked into the "call me when you hurt" mentality. I now see Track Your Plaque as a way for people to seize control over coronary plaque with minimal assistance from their doctors. Indeed, some of our Members have achieved reduction of their plaque in spite of their doctors.

This is just the tip of the iceberg of what's to come. Brace yourself for a cataclysmic shift in returning health to you and away from those who would profit from your misfortune.

Vitamin D for Peter, Paul, and Mary

Why is it that vitamin D deficiency can manifest in so many different ways in different people? One big reason is something called vitamin D receptor (VDR) genotypes, the variation in the receptor for vitamin D.

It means that vitamin D deficiency sustained over many years in:

Peter yields prostate cancer

Paul yields coronary heart disease and diabetes

Mary yields osteoporosis and knee arthritis.


Same deficiency, different diseases.

VDR genotype-determined susceptibility to numerous conditions have been identified, including Graves' thyroiditis, osteoporosis and related bone demineralization diseases, prostate cancer (Fok1 ffI genotype), ovarian cancer, rheumatoid arthritis, breast cancer (Fok1 ff), birth weight of newborns, melanoma and non-melanoma skin cancers, insulin resistance and metabolic syndrome, susceptibility to type I diabetes, Crohn's disease, and neurological or musculoskeletal deterioration with aging that leads to falls, respiratory infections, kidney cancer, even periodontal disease.


Why is it that the dose of vitamin D necessary to reach a specific level differs so widely from one person to the next? VDR genotype, again. Variation in blood levels of 25-hydroxy vitamin D from a specific dose of vitamin D can vary three-fold, as shown by a University of Toronto study. In other words, a dose of 4000 units per day may yield a 25-hydroxy vitamin D blood level of 30 ng/ml in Mary, 60 ng/ml in Paul, and 90 ng/ml in Pete--same dose, different blood levels.

Should we all run out and get our VDR genotypes assessed? So far the data have not progressed far enough to tell us. If, for instance, you prove to have the high-risk Fok1 ff genotype, would you do anything different? Would vitamin D supplementation be conducted any differently? I don't believe so.

Virtually all of us should be supplementing vitamin D at a dose that generates healthy blood levels, regardless of VDR genotype. For those of us following the Track Your Plaque program for coronary plaque control and reversal, that means maintaining serum 25-hydroxy vitamin D levels between 60-70 ng/ml.

As the fascinating research behind VDR genotype susceptibility to disease unfolds, perhaps it will suggest that specific genotypes be somehow managed differently. Until then, take your vitamin D.

Blowup at Milwaukee Heart Scan

A local TV investigative news report just ran a critical report of the goings-on at Milwaukee Heart Scan:

Andy Smith went to Milwaukee Heart Scan. "It passed the smell test like a road kill skunk. I mean it was bad," Smith explained.

Our hidden cameras went inside the high pressure sales pitch. "On a good day I sell eight, nine, 10 people. On a bad day probably three," sales manager Angelo Callegari told us.


What the heck happened?

Let me tell you a story.

Back in 1996, I learned of a new technology called UltraFast CT scanning, or electron-beam tomography (EBT), a variation on the standard CT technology that permitted very rapid scanning, sufficiently rapid to allow visualization of the coronary arteries. Back then, only a few dozen devices had been established nationwide.

But the technology was so promising and the initial data so powerful that I lobbied several hospital systems in town to consider purchasing one of the $1.8 million devices. I was interested in applying this exciting technology for early detection of coronary heart disease in Milwaukee. While administrators from several hospitals listened, they quickly lost interest when they figured out that the scanner was primarily a tool for prevention, and would not be directly useful to increase revenue-generating hospital procedures.

I floundered about for a year, trying to drum up support for obtaining a scanner. The manufacturer of the device, Imatron, put me in touch with a couple from Indiana who were also interested in setting up a scanner and had actually obtained the investment capital to do it. We met and, over the next year, got Milwaukee Heart Scan up and running. I served as Medical Director (but never an investor or owner).

Milwaukee Heart Scan was busy from day one, performing EBT heart scans, as well as CT coronary angiograms as long ago as the late 1990s, virtual colonoscopies, and other imaging tests. We all spent a great deal of time educating the public and physicians on what this technology meant for detection and prevention of disease.

Despite the public's perception that the owners, Nancy and Steve Burlingame, were making a bundle of money, in reality they could barely pay their expenses. As price competition heated up in Milwaukee with the lower-cost competing multidetector scanners cropping up, the Burlingames often did not pay themselves.

My interest was to keep this device afloat. I therefore told the Burlingames that they should pay their bills first--their staff, overhead, the scanner costs, and pay themselves--and not worry about reimbursing me for the (very modest) heart scan interpretation fees. For several years, I read thousands of scans without any compensation. But that was okay with me--I just wanted to be sure this device remained available.

But in 2008, some business people from Chicago contacted Steve Burlingame with prospects of applying a contract model of long-term scanning to patients,i.e.,getting people to sign a several-year contract for discounted imaging. They proposed that Milwaukee Heart Scan offer heart scans for free to get people in the door.

What was peculiar about all this is that none of the four physicians on staff at Milwaukee Heart Scan had any knowledge of these discussions at all, including myself. Personally, I figured something was afoot when I came in to read scans in the summer of 2008. While, ordinarily, there is a single stack of scans to read from the preceding few days, this time there were numerous stacks of scans, hundreds of scans in all. Not a word had been said to me or my colleagues. I quickly figured out (thanks to the staff filling me in) that they had been offering scans for free. Not surprisingly, many people took them up on the offer.

Up until then, I had been readily willing to read heart scans without compensation, provided I could perform scan readings in a modest time commitment every week on the weeks it was my responsibility. But work several hours every day for free? Impossible.

My colleagues and I were deeply upset and concerned and insisted on a meeting with all the people involved, including the Burlingames, who had engineered this new sales program. We expressed serious reservations about what they were doing and insisted that they dramatically scale back the promises being made to people. I personally asked that they fire several of the people they had hired as sales people, given what we thought was unprofessional appearance and behavior.

The Burlingames and their new business partners essentially thumbed their noses at the physicians and ignored our advice. So, of the four physicians (one radiologist, three cardiologists), three of us resigned. (The one remaining cardiologist, I believe, didn't really understand what was going on.)

Apparently, after we left, the hard sales tactics continued. The news media got hold of the story through some understandably disgruntled people, and you know the rest.

The tragedy in all this is that, as wonderful as heart scans are, they don't make money for the people who invest in the technology. In the sad case of Milwaukee Heart Scan, it meant that my former friends, the Burlingames, turned to questionable tactics to make this technology pay.

Make no mistake: Heart scans remain a wonderful medical imaging modality. EBT, in particular, remains a fabulous technology that would--even today--remain the pre-eminent means to image coronary arteries, except that GE (who acquired Imatron some years ago) decided that a more direct path to bigger revenues was to purchase Imatron, then promptly scrap the entire operation, choosing to focus on multidetector technology exclusively.

Don't let the spotty past and petty ambitions cloud the fact that heart scans remain the best way to identify and track coronary plaque. Just don't get tempted by the offer of any free scans "without obligation."

Do you work for the pharmaceutical industry?

In response to my post, Lovaza Rip-off, I received this angry comment:


Very high triglycerides, as you all know, is a very serious and life-threatening condition. Therefore, it is very important that any medication you take for treatment must be FDA proven and scientifically backed. This is true for a few reasons. First, there have been zero studies done to show the effects of Costco brand fish oil pills on patients with high triglycerides. So, you cannot assume, simply because the pills you are taking "claim" to have a certain amount of Omega 3 in the them, that they actually do (supplement labeling is self-submitted by the company, and not regulated by any external or 3rd party agency).

Secondly, the other components in fish oil, and maybe in Costco brand (no one knows because it isn't on the label) can actually inhibit the bioavailablity of Omega 3, most notably, Omega 6. And, nowhere on the Costco label does it tell you how much Omega 6 is in it. We also cannot underestimate the importance of purity with these compounds: a top selling brand of fish oil found stores like CVS was recently recalled because it was found to have large amounts of fire retardant in it! These supplements are NOT regulated by the FDA.

Thirdly, be careful when you compare costs. The cost of hospitalization due to acute pancreatitis (a risk of very high triglycerides) far outweighs the cost of taking Lovaza for even several years. If you have a real disease, you need a real drug. And, until Costco does a prospective long-term clinical trial to show that it lowers triglycerides, it should not be used in place of Lovaza.

Finally, I am a living example of how taking a high-potency supplement form of Omega 3 barely lowered my triglycerides, yet within 2 weeks of being on Lovaza there was a significant difference. I am now at my goal. So, before you knock a company, that, in my opinion, has saved my life, please do your research and do not mislead people into thinking that an Omega 3 is an Omega 3 is an Omega 3. If your insurance covers the most potent, the most pure, and the ONLY proven Omega 3 pill on the market, you should be thankful.



The comment was posted anonymously, so I don't know who it came from. But I can tell who I think it is: Someone who works for the drug industry.

This is a common phenomenon: Large corporations are fearful of the comments that are generated on internet conversations and other media. On the internet, there are actually people whose job it is to do "damage control." I suspect this came from one of them.

Why bother? Surely there are better things to do? Well, that's easy. There are billions of dollars at stake. Lovaza, in particular, is sold on the perception that it is somehow superior. If word gets out that maybe you can achieve the same results at a fraction of the cost . . .

Perhaps the "commenter" should also question whether omega-3 fatty acids can come from eating fish.

As part of my cardiology practice, I provide consultation on complex hyperlipidemias, or unusual lipid abnormalities. I have many patients with something called familial hypertriglyceridemia, a genetic condition that permits triglyceride levels of 500, 1000, even many thousands of mg/dl, levels that, as the anonymous commenter points out, can be dangerous.

I virtually never prescribe Lovaza for these people. In their treatment program, I use simple fish oil supplements, such as that from Costco, Sam's Club, or other retailers. I have not witnessed a single failure in treating these people and reducing triglycerides. People with lesser triglyceride abnormalities likewise respond very nicely to inexpensive fish oil that we can buy at the health food store. (I do rely on useful services like Consumer Reports and www.consumerlab.com to reassure us that no pesticide residues, mercury, or other contaminants are in the brands we use.) Excellent, high-quality fish oil supplements are sold by Carlson, Life Extension, Barlean's, even the Members' Mark brand from Sam's Club.

So, the notion that only prescription fish oil is capable of reducing triglycerides is, in a word, nonsense.

Take that back to your CEO.

How important is high blood pressure?


Control of blood pressure is crucial for coronary plaque control and stopping your heart scan score from increasing.

Dr. Mehmet Oz (of Oprah fame and a cardiac transplant surgeon at Columbia University) made graphic point of this on the ABC TV news show, 20/20, last evening on an episode called "Our Bodies: Myths, Lies, and Straight Talk". (See a summary on the ABC News 20/20 website at http://abcnews.go.com/2020/story?id=2109291&page=1)

Although I believe he somewhat overstated the case for hypertension (proclaiming "If you're going to remember one number, if you're going to focus and fixate on one number in your entire health profile, it better be your blood pressure"), he made the point that a blood pressure of 115/75 is what you should have for optimal health.

I couldn't agree more. Unfortunately, the old advice that desirable blood is 140/90 or less is absolutely wrong. At this level, we see flagrant increases in heart scan scores. We also progressive enlargement of the thoracic aorta, the large vessel that leaves the heart and branches to provide the major arteries of the body. Growth of the aorta to an aneurysm is also common at these formerly acceptable blood pressure. (The diameter of your aorta in the chest is an easily obtainable measure on your CT heart scan.)

The blood pressure you need for halting and reversing plaque growth on your heart scan is indeed 115/75 or less. (Not so low, however, that you're lightheaded.) This is the blood pressure that you were meant to have evolutionarily. It's also the blood pressure that helps tremendously in keeping your aorta from enlarging.

Watch for an upcoming exhaustive report on blood pressure and its plaque-raising effects and how to reduce it using nutritional strategies on the www.cureality.com membership website.

Is your doctor in cahoots with the hospital?

I got a call from a doctor about a patient we've seen in past.

"I've got Tricia in the office. She's been having some kind of chest and abdominal pain. I think it's esophageal reflux, but just to be safe I'm sending her to the hospital."

I advised this physician that, given Tricia's low heart scan score, she was unlikely to be having a coronary "event" like heart attack or unstable symptoms. It wasn't impossible, but just highly unlikely.

As the patient was without symptoms at the moment and had driven herself to his office, I offered to perform a stress test immediately. (Though stress tests are of limited usefulness in people without symptoms, they can be useful provocative maneuvers in people with symptoms of uncertain significance.)

The doctor declined. Tricia was, after all, in his office and he was responsible for any decisions despite any objections I voiced. Well, Tricia was directed by her doctor to go to a local hospital, though one with an especially notorious reputation for putting virtually anyone they can get their hands on through as many procedures as possible.

As you might guess, this doctor was closely associated with this hospital. He and his colleagues obtain incentives (or are penalized) if they do not generate revenue-producing procedures for the hospital.

So, guess what? Tricia ended up with several procedures, all of which yielded nothing--except $30,000 in revenues from Tricia's insurance company.

I harp on this deplorable state of affairs because it is utterly, painfully, and shamefully TRUE. Just look at the hospital and you'd better brace yourself for a series of tests that could cost you the equivalent of a nice 3 bedroom home. If they were truly necessary after the failure of preventive and other simple efforts, fine. But, all too often, they are driven by profit motives.

Could I have stopped this somehow from occurring? After all, Tricia was reasonably aware of the way we do things around here. I fear that even this failed to serve Tricia well. But I remain hopeful that, as we build broader awareness of these issues, that more and more people and physicians will stand up and refuse to tolerate the status quo.

Where is the Track Your Plaque program going?

I spend a lot of time worrying about how people can be helped to navigate through this program.

Take, for instance, the man in rural Texas who, while traveling in Dallas, got a heart scan on a whim. His score was 990. When he took the report back to his doctor, he got a smirk--and that's all. When he came to the Track Your Plaque program, he lacked a physician advocate to help him.

Or the woman from Florida who sought opinions from two reputable cardiologists for her heart scan score of 377. Both advised her that she needed a heart catheterization--despite her lack of symptoms, her 5-day-a-week exercise program, and normal stress test. She also lacks a physician advocate who acts on her behalf, helping her achieve success, rather than just churning her for money from hospital procedures.

For people like this and for others, I see the Track Your Plaque program evolving in several directions:

1) An online clinic--You enter and we take your "hand" and lead you step by step through the process, not only at the beginning, but over the months and years. This would help clear up some of the confusion and zigzags that some people experience trying to navigate through the program.

2) Develop physician and non-physician partners--The woman in Florida, for instance, could be referred to a doctor nearby who understands the program and is able to assist her. At present, this is virtually impossible because of the bias towards heart procedures, drugs as the sole treatment for heart disease risk, and the superficial physician-patient relationship. The majority of practicing physicians just don't understand the program despite the fact that it is based on sound clinical and experimental data. But it will in time.

Looking back, we've come a long way. I remember first having patients undergo heart scans 10 years ago. My colleagues laughed or called it "silly". The general public didn't know what they meant.

Now we're talking about how to broadcast the most powerful heart disease prevention program available in the world to a larger audience, but making it easier and more accessible. Mass media like Oprah's two hour-long spots helped, but we need to make the next leap. Not just identifying hidden heart disease to feed the hungry cardiovascular hospital procedure monster, but to educate/inform/empower the public on what to do with the scan once they've had it.

Who cares about triglycerides?

Walter's triglycerides were 231 mg. His LDL cholesterol was "favorable" at 111 mg, HDL likewise at 49 mg.

"Everything looks good," his doctor declared.

"Do you think the triglycerides are okay, too?" Walter asked.

"Well, the guidelines do say that triglycerides should be less than 150, but I believe you're close enough. Anyway, triglycerides don't really cause heart disease."


When I met Walter, I made several comments. First of all, in light of his heart scan score of 713, none of his numbers--HDL, LDL, or triglycerides-- were acceptable. But the triglycerides were glaringly and terribly too high.

Why? What exactly are triglycerides?

Triglycerides are a basic fat particle that, though they do not cause heart disease directly, trigger the formation of an array of abnormal lipoprotein particles in the blood that are among the most potent causes of heart disease known.

These abnormal lipoprotein particles include small LDL, VLDL, and IDL (intermediate-density lipoprotein--a really bad pattern). Excess triglycerides also cause HDL to drop. They also cause a distortion of HDL structure, causing the particles to become abnormally small. Small HDL is also useless HDL, unable to provide the protection that HDL is designed to do.

So Walter's elevated triglycerides are, in reality, a substantial red flag for an entire panel of abnormal particles that contribute to the growth of his coronary plaque.

So, if you get this kind of commentary on your triglycerides, ask for another opinion. (Track Your Plaque Members: Also see Triglycerides: Mother of meddlesome particles at http://www.cureality.com/library/fl_dp002triglycerides.asp.)

Total cholesterol and heart scans

Andy was fearful of heart disease in his life. At age 52, he'd already had four CT heart scans--one each year on or near his birthday.

Yet, when I looked at Andy's scans, his scores had been increasing 20-24% per year. Each and every score was greater by 20% or more over the previous.

So I asked Andy what steps he had taken to stop this relentless progression. "Well, I've always been real health conscious. But ever since my first scan, I really started sticking to a healthy diet, exercising nearly every day, and I take a bunch of supplements."

"What did your doctor advise?" I asked.

"Well, Dr. ---- said that nothing needed to be done, since my total cholesterol was always below 200."



Men's Health magazine's fabulous story about the folly of using total cholesterol to gauge heart disease risk.




Aaaauuuggghhh!! Wrong!

This man was, in fact, at rapidly escalating risk for heart attack. This rate of growth simply can't continue forever without igniting this bomb.

A total cholesterol below 200 is meaningless, as Andy's increasing coronary plaque proved. For instance, you can have a total cholesterol of 165 mg but with an HDL cholesterol of 27 mg. This would constitute very high risk for heart disease despite the low total cholesterol. The low HDL pattern is among the most common reasons for a misleading total cholesterol. Small LDL, high triglycerides, and lipoprotein (a) are other frequent reasons.

Andy, run the other way! Do not heed this doctor's advice! You need a solid answer to the question: Why exactly do I have coronary plaque in the first place?

Then, agree on a treatment program that corrects your specific causes.

Cardiologists out of touch

This weekend, I'm fulfilling some responsiblities I have every so often to some of the local hospitals. It gives me a chance to interact with many of my colleagues who are likewise "on call" for the weekend.

I tried to strike up several conversations with colleagues about how they were managing heart disease prevention. I received blank stares, puzzled looks, indifference. One colleague declared that 80 mg of Lipitor is all you need to know.

These same colleagues are the ones scrambling for the heart attack patients in the emergency room, climbing over one another for consultation in the hospital for patients with chest pain and heart failure. They're consumed with expanding the range of procedures they can perform.

Carotid stenting is hot. So is stenting of the leg arteries. Defibrillators have been a financial bonanza. Opportunities abound on how to add these procedures to a cardiologist's abilities.

But heart disease prevention? How about heart disease reversal?

Frankly, I'm embarassed by my colleagues' lack of interest. Imagine we had a cure for breast cancer--not a palliative therapy that just slows the disease down or prolongs life, but actually cures it once and for all. I would hope that all physicians and oncologists would learn how to accomplish this. What if instead they focused on learning new ways to remove breasts, administer new toxic chemotherapies, etc. but ignored the whole idea of cure?

This is what is happening with coronary plaque reversal. The answer is right in front of them, but the vast majority (99%) of cardiologists choose to ignore it. After all, prevention and reversal simply don't pay the bills.

That means that, in 2006, you simply cannot rely on your cardiologist to counsel you on how to achieve regression or reversal of coronary plaque. How about your internist, family physician, or primary care doctor? Well, they're busy doing pneumovax injections, Pap smears, managing knee and hip arthritis, low back pain, diarrhea, headaches, sinus infections and . . yes, dabbling in heart disease prevention.

And, for the most part, doing a miserable job of it. What you generally get echoes the drug manufacturers pitch: Take a statin drug, cut the fat in your diet.

Until the majority of doctors catch on, you're going to have to rely on sources like the Track Your Plaque program for better information.

What if your lipoproteins are perfect?

Demystification

Once upon a time, remember how medical information was mysterious, hospitals were places where frightening, inscrutable things happened, diseases were strange maladies that struck without reason, and obtaining information about health was like hunting for buried treasure? The full extent of many peoples' understanding of health came through relatively anemic sources like Readers' Digest. (Remember "I am Joe's Colon"?)

Compare this to what we have now. If I wanted to obtain information about ankylosing spondylitis (a rare genetic disease of the spine), a Google search yields 1.46 million citations. Not all the information, of course, is helpful or relevant, but there's certain to be a bounty of information that far exceeds what you could have uncovered 40 years ago.




Suppose you enter the search phrase "antithrombin III" into your Google search. Citations: over 900,000. (The number of search citations, in fact, exceeds the number of Americans with a deficiency of this blood clotting protein!)

The same is true with heart disease. There was a time, not more than 30-40 years ago, when information about the heart and heart disease was hard to come by. The most you would find were superficial discussions about heart attacks, what chest pain means, descriptions of bypass surgery. Ask your doctor, you'd likely receive a brief, cursory response about how you probably shouldn't worry it.

Even during medical school in the 1980s, I remember struggling to get answers to my questions from faculty during medical school and medical training. It was as if providing too much information would eliminate the advantage superiors wielded over trainees.

The same selfish sentiment, the "I know something you don't know" mentality reminiscent of a schoolboy's "naa na na naa naa!" unfortunately persists. But it is rapidly disintegrating. Soon it will join the junk heap of medical mis-information accumulated over the years (a big pile, to be sure). The internet and, I'll admit (grudgingly), the media, have been responsible for demystifying the formerly mysterious and indecipherable world of health.

You now have, at a moment's disposal, access to an extraordinary array and breadth of health information that was inconceivable just a few years ago.

Times are changing. Doctors no longer hold the monopoly over health information. The public--YOU--are rapidly becoming the arbiters of health, the informed consumers of a soon-to-be retail product called health care, and the increasingly savvy judges of what should join the mainstream path of health. It is all part of this wave of change that I've been advocating: the emerging concept of self-empowerment in healthcare.

Added to the junk heap of health-mistakes-of-years-past will be medical protectionism over health information, heart procedures, drug industry excesses, nutritional mis-information, among others. The demystification of health information will open the floodgates of individual insight into health. It delivers control over your own health destiny straight into your own lap.

Everything has omega-3

Walking the supermarket aisles, you may have lately noticed that numerous new products are appearing sporting "omega-3s" on the label.

Some products simply contain alpha-linolenic acid, a tiny amount of which is converted to the biologically active omega-3s, EPA and DHA. Natural Ovens' Brainy Bagel, for instance, carries a claim of "620 omega-3."



I find this confusing and misleading, since people will often interpret such a claim to mean that it contains 620 of EPA and DHA, similar to two capsules of standard fish oil (1000 mg capsules). Of course, it does NOT. I find this especially troublesome when people will actually stop or reduce their fish oil, since they've been misled into thinking that products like this bread contain active omega-3 fatty acids that yield all the benefits of the "real stuff."


Other products actually contain the omega-3, DHA, though usually in small quantities. Breyer's Smart with DHA is an example, with 32 mg DHA per container.


I find products with actual DHA (from algae) a more credible claim. However, the Center for Science in the Public Interest (CSPI) has looked at the actual contents of DHA in some of these products and found some discrepancies, including amounts of DHA less than the labeled amount and claims of omega-3 wihtout specifying DHA vs. linolenic acid. (It's probably linolenic acid, if it's not specified.)

All in all, the addition of DHA to food products is a nice way to boost your intake of this healthy omega-3. However, keep in mind that these are processed, often highly processed, foods and you will likely pay a premium for the little boost. For now, stick to fish oil, the real thing.

For a brief summary of the CSPI report and a link to the Nutrition Action Newsletter, see Omega-3 Madness: Fish Oil or Snake Oil.

Are cardiologists the enemy?

I'm sitting at dinner with two colleagues. One is a cardiology colleague, another an internist who, in addition to practicing general internal medicine, also takes heart disease prevention very seriously. He has, in fact, participated in the Track Your Plaque program and dropped his heart scan score substantially.

"Why don't we see you in the cath lab much?" my cardiology colleague asked me. He was puzzled, since he knew my background in cath lab work from years before, spending day and night doing procedure after procedure. He spends virtually all his days there.

"Well, my patients simply don't have events any more. Heart attacks and angina among people in my program are just about non-existent. They don't have symptoms and they don't have to go to the hospital. I can't remember the last time that I was woken up in the middle of the night for an urgent procedure for one of my patients."

The internist across the table smiled and expressed his agreement. "That's the same thing I'm seeing: No heart attacks, very few if any referrals to cardiologists for procedures. I remember when it was a several times a week thing. Now, almost never. "

Looking at my cardiology colleague, I saw the usual cardiologist reaction: Eyes searching left and right and behind us for something more interesting. Certainly, talking about a virtual cure for coronary heart disease was just too damn dull.

Such is the attitude of 98% of my colleagues: If it doesn't generate a revenue-producing procedure, why bother? Prevention is for general practitioners, the line of thinking goes. "And anyway, I'm too busy doing procedures! I don't ahve time to talk about prevention and health!" Of course, the poor general practitioner is already overloaded with caring for arthritis, flu, diabetes and all the new drugs for diabetes, headaches, vaccinations, diarrhea, and . . .oh, yes, heart disease prevention.

Are cardiologists the enemy? No, of course they are are not. But they often act like they are. Talking to cardiologists is like going to the car dealer with your checkbook out, pen in hand. The salesman gets to write the check himself and you just sign it. Talk to a cardiologist and more often than not you will end up with a heart procedure--whether or not you need it.

Unfortunately--tragically--they often forget what they are supposed to be doing: Taking care of a disease by preventing it. Putting in a defibrillator is not preventing a disease. Putting in three stents, laser angioplasty, and thrombectomy are not ways of preventing a disease.

I'm thankful for my internist friend who sees the light. Coronary heart disease is a an easily measurable, quantifiable, preventable, and REVERSIBLE process for many, if not most, people when provided the right tools. But don't ask your neighborhood cardiologists to give you those tools.

Are CETP inhibitors kaput?

Was torcetrapib’s crash and burn fatal for this class of drug?

At the 2007 American Heart Association meetings in Orlando, Florida, Dr. Philip Barter of Sydney, Australia, presented an update of the ILLUMINATE drug trial for the once-promising drug, torcetrapib, the billion-dollar bet that Pfizer made on its first entry into the new drug class.

You may recall that the crash and burn of Pfizer’s torcetrapib in December 2006 made headlines and prompted enormous disappointment for many patients and doctors who had hoped for a new drug choice to raise HDL cholesterol. Pfizer executives (heads flew!) and investors were also disappointed, anticipating release of a drug that might have become the number one biggest selling drug in the world—ever, surpassing even Lipitor's® $13 billion annual sales.

Torcetrapib is the first among the “cholesteryl-ester transfer protein inhibitors,” or CETP-inhibitors, drugs that block the exchange of cholesterol and triglycerides between HDL and VLDL particles and prevent formation of the unwanted small LDL particles. Preliminary efforts suggested that effects were positively enormous.

However, the 15,000-participant trial was abruptly terminated after 550 days when an excess of deaths were identified among the group taking the experimental drug: 59 deaths in control group; 93 deaths in the torcetrapib group.

In addition, cardiovascular events were 24% greater in the torcetrapib group, numbering 373 compared to 464 in the no-torcetrapib group, including a substantially greater number of heart attacks and hospitalizations. Another surprise came in the way of cause of death among some of the torcetrapib patients, with an excess of deaths due to cancers (twice as many in the torcetrapib group), strokes, and infections.

Why the divergence: enormous improvements in cholesterol values, yet increase in adverse effects including more heart attack? Deeper digging by the principal investigators uncovered unexpected distortions of electrolytes like sodium and potassium. They then re-analyzed blood samples from participants on both sides of the trial and discovered that participants taking torcetrapib experienced significant rise in the blood pressure hormone, aldosterone. This, they surmised, also likely accounted for the 4 mmHg average rise in blood pressure among those taking the experimental drug. (This is the same pathway blocked by blood pressure drugs like ACE inhibitors lisinopril and enalapril, ARBs like losartan.)

Simultaneously (what a coincidence!) with the torcetrapib data, investigators at competing drug manufacturer, Merck, reported encouraging data with their version of CETP inhibitor, anacetrapib. In a phase II FDA trial of 589 patients, anacetrapib reduced LDL-C levels by up to 40% and increased HDL-C up to 139%.


Spokesman Daniel Bloomfield, M.D., of Merck Research Laboratories reported that "The favorable lipid effects seen in this study with multiple doses of anacetrapib were significant, and confirm the continued evaluation of the clinical benefits of CETP inhibitors in the treatment of dyslipidemia." Quick to distinguish this drug from torcetrapib’s track record of dangerous effects on blood pressure, he added that "the decreased LDL-C concentrations, increased HDL-C concentrations and no demonstrable increase in blood pressure seen with anacetrapib are particularly encouraging results of this study."

However, the data reported only an 8 week expereince. Given the experience with torcetrapib, longer term data will obviously be required to assess safety. After Pfizer spent over $1 billion and sacrificed lives to obtain this experience, Merck will need to tread carefully.

It will clearly be many years before we have a confident answer on whether the CETP-inhibitor class of drugs will be a safe choice for correction of cholesterol abnormalities, especially low HDL. Are we helpless until then?

Though CETP inhibitors offer the potential for a one-stop opportunity to raise HDL substantially, there are still many strategies available to raise HDL.

Strategies that raise HDL and are available today include:
• Weight loss—to your ideal weight. A very effective strategy.
• Reduction in processed carbohydrates—like breads, pasta, cookies, pretzels, etc. Note that very low-fat diets reduce HDL. Often a huge effect.
• Fish oil—A small effect, more dramatic when triglycerides are high.
• Niacin—Vitamin B3, the best we have at present. Doses of 500-1500 mg per day raise HDL 20–50%; work with your doctor if you are contemplating niacin. We use this agent everyday and have had great success; good hydration is key to minimize the annoying “hot-flush” effect.
• Dark chocolate—40 grams, or about 2 inches square, a delicious way to squeeze out a little rise in HDL.
• Alcoholic beverages—Red wines are almost certainly the preferred route, rich in flavonoids.
• Exercise—HDL-raising effects vary, but can sometimes be as much as 10–20 mg.
• Other drugs—Though not commonly used for this effect, drugs like pioglitazone (for diabetes and pre-diabetes); fibrates (Tricor® or fenofibrate; Lopid® or gemfibrozil); and Pletal® or cilostazol are occasionally prescribed.
• Vitamin D—You won’t find validation of this effect in any scientific study, but our emerging experience in our heart disease reversal program is suggesting that this neglected nutrient can exert powerful HDL-raising effects. In fact, supplementing vitamin D has made my life much easier.


And, last I checked, none of these HDL-raising strategies are ever fatal.

Roto Rooter for plaque




Joe, a machinist, was frightened and frustrated.

With a heart scan score of 1644 at age 61, his eyes bulged when I advised him that, if preventive efforts weren't instituted right away, his risk for heart attack was a high as 25% per year. Joe had "passed" a stress test, thus suggesting that, while coronary plaque was present--oodles of it, in fact--coronary blood flow was normal. Thus, there would be no benefit to inserting three stents, say, or a bypass operation.


(Illustration courtesy Wikipedia)

"I don't get it, doc. Why can't you just take it out? You know, like Roto-Rooter it out? Or give me something to dissolve it!"

Of course, if there were such a thing, I'd give it to him. But, of course, there is not. It doesn't mean that there haven't been efforts in this direction over the years. Among the various attempts made to "Roto-Rooter" atherosclerotic plaque have included:

Coronary endarterectomy
This is a drastic procedure rarely performed anymore but enjoyed some popularity in the 1980s and 1990s. Coronary endarterectomy was performed during coronary bypass surgery, but few thoracic surgeons performed it. Milwaukee's Dr. Dudley Johnson was the foremost practitioner of this procedure (retired a few years ago after his own bypass operation) with a mortality in excess of 25%. A very dangerous procedure, indeed. The technical hurdle, beyond the tedium and length of time required to remove plaque that had a tendency to fragment, was blood clot formation after tissue was exposed upon plaque removal. I saw many lengthy hospital stays and deaths following this procedure.

Coronary atherectomy
This is an angioplasty-type procedure that has gone through several variations over the years.

In the early 1990s, transluminal extraction atherectomy (TEC) was a technique involving low-rpm drill bits with a suction apparatus that was used to clear soft debris, usually from large coronary arteries or, more commonly, bypass grafts. Then came direction atherectomy, in which a steel housing contained a sharp drill bit that captured atherosclerotic plaque in an aperture along the housing length and stuffed it into a nosecone, retrieved once the device was removed.

Then came high-speed rotational atherectomy in which a diamond-tipped drill bit rotated up to 200,000 rpm and essentially pulverized plaque to flow downstream and, presumably, eventually captured by the liver for disposal. Rotational atherectomy is still in use on occasion. Laser angioplasty, usually using the excimer wavelength, vaporizes plaque. I did plenty of all of these back in the early and mid-1990s.

While all atherectomy procedures sound clever, they are all plagued by the same problem: vigorous return of plaque. Remove plaque, it grows back. There are few instances today in which atherectomy is still performed.

Chelation
This involves a metal-binding, or "chelating," agent like EDTA normally used in conventional practice for lead poisoning. Usually administered IV, some have also advocated oral use. People who use chelation also tend to believe in faith healing and other practices based on faith, not science. There is an international trial that is nearing completion that should provide the final word on whether there is any role to intravenous chelation.

There are numerous other oral treatments that claim a Roto-Rooter-like effect. Nattokinase, for example--an outright, unadulterated, and unqualified scam.

Unfortunately, the helpless, ignorant, and gullible are many. When frightened by the specter of heart disease, there are plenty of people who will willingly pay for the hope provided by clever ads, fast-talking salespeople, and unscrupulous practitioners.

So, Joe, there is no Roto-Rooter for coronary atherosclerotic plaque, at least one that is safe, doesn't involve a life-threatening effort, provides results that endure beyond a few months, and truly works.

The Track Your Plaque program may not be easy. There are obvious common hurdles to adhering to these concepts: obtaining lipoprotein testing, getting intelligent interepretation of the results, persuading your doctor to measure vitamin D blood levels, battling the onslaught of prevailing food propaganda that confuses and misleads. The Track Your Plaque program also requires time, at least a year.

But it's the best program there is. Do you know of anything better?

"Beware nutritional supplements"



In our effort to expand the reach for the nationwide conversation on heart disease reversal, I'd like to welcome the newest contributor to the Track Your Plaque family, a new Member blogger, Heart Cipher.

We first came to appreciate the insights of Heart Cipher on our Member Forum. His curiousity and ability to cut through the bull--- have won over our hearts and minds. I think you will appreciate his unique perspective as someone who has experienced first hand the inadequacies of the present procedure-focused, drug-obsessed standard of medical care that dominates, yet has the intelligence and worldliness to recognize that there are better ways.

Read his post about meeting a new cardiologist for the first time and the reaction he receives when he describes the Track Your Plaque program here.

http://www.heartcipher.com/

The rules of reversal


For the last few years, most practicing physicians have followed a rough blueprint for cholesterol management provided by the Adult Treatment Panel-III “consensus” guidelines, or ATP-III, a lengthy document last released in 2001, updated in 2004.

For instance, ATP-III suggests reducing LDL cholesterol to 100 mg/dl or less for those deemed to be at high risk for future heart disease, arbitrarily defined as a risk of 20% over a 10-year period. It also suggests that a desirable triglyceride level is no more than 150 mg/dl. The ATP-III guidelines have been the topic of discussion in thousands of medical meetings, editorials, and reports. They have served as the basis for many dinners at nice restaurants, weeks in Vegas or Honolulu, many, many lunches catered by pharmaceutical representatives. For most internists, family doctors, cardiologists, and lipid clinics, ATP-III is the Bible for cholesterol management.

AT-III has also become the de facto standard that could conceivably held up as the prevailing "standard of care" in a court of law in cases of presumed negligence to treat cholesterol values. “Doctor, would you agree that the consensus guidelines issued by the National Institutes of Health and endorsed by the American Heart Association state that LDL cholesterol should be reduced to 100? You do? Then why was Mr. Jones’ LDL not addressed according to these guidelines?”

Who was on the ATP-III panel and on what scientific evidence were the guidelines based? Several problems:

1) Of the 9 physician members of the panel, 8 had ties to industry, some of them quite intimate.

2) The studies upon which the guidelines were based and figure prominently, such as the Heart Protection Study, PROVE IT, and 4S, were all funded by the pharmaceutical industry. Of course, it would be unreasonable to expect anyone other than the pharmaceutical industry to fund drug studies. But prominently neglected or understated in the guidelines are all the other insights and treatments for coronary atherosclerotic risk available that were NOT funded by industry.

Of course, there’s money to be made in reducing LDL cholesterol. Lots of it--$23 billion last year alone, in fact. Just keeping that fact in mind makes the ATP-III guidelines make far better sense.

ATP-III is really not a blueprint for heart disease prevention. It is a blueprint--by industry, for industry--on how and when to treat LDL cholesterol.


But what if ATP-III had been a map for navigating coronary plaque reversal instead? What if it were not obsessed with just reducing LDL cholesterol, but was focused on providing the corner internist, family doctor, or cardiologist a roadmap for navigating the highways and byways of reversal?

That would be interesting. Mainstream reversal. Imagine that.

Among the difficulties is that the path to reversal is not lined with deep pockets. Treat LDL and who gains? That's easy. Reverse heart disease and who gains? Beyond LDL reduction, very few (beyond you and me, of course).

That’s why the call for a new Age of Self-Empowerment in healthcare is necessary now more than ever. In my view, in the foreseeable future, we will not have an ATP-III-like blueprint for heart disease control or reversal, nor will we witness a boom of nationwide appreciation that coronary atherosclerosis is a reversible process.

It’s time to take the control back and put it in our own hands. Don't expect the American Heart Association to do it. Don't expect the pharmaceutical industry to do it. If there's anyone who's going to do it, it's YOU.

Incurable wheataholics

Greg slumped back in his chair.

"I'm sorry, doc. I feel like the world's biggest schlump!"

He was referring to the fact that he had gone wheat-free for two months--eliminated all breads, bagels, donuts, pasta, breakfast cereals, crackers, pretzels--and promptly lost 30 lbs. He felt great, discovered new levels of energy he thought he'd lost long ago.

Then some friends convinced him to have some cheeseburgers at a fast food restaurant.

"After that, it was downhill. I couldn't get enough. My wife made chile and I had to have four slices of bread with it. Then I'd have two more. I just couldn't stop."

Now, having regained the 30 lbs in the space of another two months, Greg was expressing his disgust.

And it's not the first time. Greg has struggled with his wheat-alholism for as long as I've known him. I've tried motivating him by showing him the flagrant lipoprotein patterns that his wheat habit and excess weight caused: markedly elevated LDL particle number, severe small LDL, low HDL, high triglycerides, high C-reactive protein, high blood sugar, high blood pressure. Greg has received a total of 7 stents over the past 5 years. His next stop is the operating room for a bypass if he can't bring his patterns and impulses under control.

But for some reason, Greg seems to always return to the wheat trough, gorging on breads, pretzels, cake, often in great quantities.

I'm not entirely sure what to do with someone with Greg's severe degree of wheat-aholism. I view wheat-aholism as similar to alcoholism. For some, it can be as addictive.

The only strategy that I know can work is to make a clean break and drop wheat products altogether. Just as an alcoholic cannot just satisfy him/herself with a drink or two a day, so a wheataholic can't be satified with just a couple of wheat crackers. It inevitably leads to the avalanche of wheat indulgences.

Perhaps we should form a new group: Wheataholics Anonymous. "Hi. My name is Greg and I'm a wheataholic."

The battle for asymptomatic disease

The heart disease revenue pie is shrinking. So is the "serving size" being shared by competing hospitals.

In other words, as more hospitals open heart programs, there is more competition for the same heart patient. Throw into the mix the drop in "acute" presentations of disease, probably due to the now widespread prescribing of statin drugs. When I first started cardiology practice 15 years ago, for instance, days and nights spent taking care of heart attacks coming through the emergency room was a common event. It still happens, but far less frequently. (I don't mean to suggest that the actual prevalence of coronary heart disease has decreased, just the acute, catastrophic version of it.)

Throw into this mix the results of the COURAGE Trial that has put a damper on the value of stents and angioplasty vs. "optimal" medical therapy in people with stable anginal symptoms, since there was little advantage of procedures. Though it has not stopped the practice, it has reduced the enthusiasm for procedures. Though data are hard to come by, I've heard talk of 10% or greater drops in total procedural volume over the past year.

It's not uncommon for hospitals to have overbuilt heart facilities in anticipation of continued growth of this--until recently--growth industry called heart disease. However, factors are converging that may provide a new profit opportunity for hospitals.

One such opportunity is CT coronary angiography. The usual scenario: Man or woman without symptoms is persuaded somehow--an ad, primary care physician, next door neighbor with a scary event, Dr. Mehmet Oz gushing about this sexy new technology on yet another Oprah episode--to undergo a CT coronary angiogram. A "severe" blockage is found, despite the lack of symptoms, and voila! A stent patient or bypass patient is created out of nothing! Do this repeatedly and systematically, and a hospital can regain its former high-procedural volume glory.

Heart scans, though I believe deeply in them and they are the basis for the Track Your Plaque prevention and reversal program, can also be used and abused this way. Asymptomatic person has a score 150. Concerned, they go to their physician who orders a nuclear stress test. An "inferior perfusion defect" is seen, presumably representing poor flow through the right coronary artery (but often just means that the diaphragm overlaps the heart muscle and yields this apparition, a "false positive" or misleading result). "But--wink--we've got to find out if there's a severe blockage, don't we? You don't want to end up in an early grave!"

Thus, the battle for new patients with asymptomatic disease is getting underway in earnest. The scramble for cardiologists to learn how to use CT coronary angiograms is proceeding at breakneck speed, with new training courses being offered nationwide several times and places every month. CT coronary angiography is a useful test, but it is also subject to enormous abuse. It also provides the ticket for the unscrupulous physician and the revenue-hungry hospital eager to expand its patient volume.

Many people believe that this cannot happen commonly in 2007, given scrutiny of practices, litigiousness, and the expectation of a moral sense in medicine. However, I've witnessed such incidents several times this month alone. If you need graphic proof of just how far this can go before action is taken, read Coronary, Stephen Klaidman's chilling tale of a cardiologist and cardiothoracic surgeon in small-town northern California who built an enormous heart center based on fabricated heart disease diagnoses. You'll also find their story in Shannon Brownlee's recently released Overtreated: Why Too Much Medicine Is Making Us Sicker and Poorer.





Of course, the Track Your Plaque program is meant principally for people without symptoms, also. But we are advocating that asymptomatic disease is a reason for prevention, not procedures. There's a difference.

By the way, the two practitioners who engineered the escapade detailed in these books, cardiologist Chae Hyun Moon and cardiac surgeon Fidel Realyvasquez, walked away with a monetary fine and suspension of their California medical licenses. It is likely that many people died because of their abusive practices, but the state struggled to make a sufficiently persuasive case for reasons that I still don't understand.

Heart disease reversal a big "No No"

I dare you: Ask your doctor whether coronary heart disease can be reversed.

My prediction is that the answer will be a flat "NO." Or, something like "rarely, in extraordinary cases," kind of like spontaneous cure of cancer.

There are indeed discussions that have developed over the years in the conventional scientific and medical literature about reversal of heart disease, like Dean Ornish's Lifestyle Heart Trial, the REVERSAL Trial of atorvastatin (Lipitor) and the ASTEROID Trial of rosuvastatin (Crestor). Reversal of atherosclerotic plaque in these trials tends to be small in scale and sporadic.

Of course, the medical literature is swamped with studies that have nothing to do with reversal, like what stent is best, what platelet-inhibiting intravenous drug is best, when should angioplasty or stents be used and when, do implantable defibrillators save lives, improvements in coronary bypass techniques, etc. There are tens of thousands of these studies for every study that focuses on the question of atherosclerotic plaque reversal.

The concept of reversal of heart disease has simply not gained a foothold in the lexicon nor in the thinking of practicing physicians. Heart disease is a relentlessly, unavoidably, and helplessly progressive disease in their way of thinking. Perhaps we can reduce the likelihood of cardiovascular events like heart attack and death with statin drugs and beta blockers. But reverse heart disease ? In your dreams!

We need to change this mentality. Heart disease is a reversible phenomenon. Atherosclerosis in other territories like the carotid arteries is also a reversible pheneomenon. Rather than throwing medicines and (ineffective) diets at you (like the ridiculous American Heart Association program), what if your doctor set out from the start not just to reduce events, but to purposefully reduce your heart's plaque? While it might not succeed in everyone, it would certainly change the focus dramatically.

After all, isn't this the theme followed in cancer treatment? If you had a tumor, isn't cure the goal? Would we accept an oncologist's advice to simply reduce the likelihood of death from cancer but ignore the idea of ridding yourself completely of the disease? I don't think so.

Then why accept "event reduction" as a goal in heart disease? We shouldn't have to. Heart disease reversal--elimination--should be the goal.

Demystification

Once upon a time, remember how medical information was mysterious, hospitals were places where frightening, inscrutable things happened, diseases were strange maladies that struck without reason, and obtaining information about health was like hunting for buried treasure? The full extent of many peoples' understanding of health came through relatively anemic sources like Readers' Digest. (Remember "I am Joe's Colon"?)

Compare this to what we have now. If I wanted to obtain information about ankylosing spondylitis (a rare genetic disease of the spine), a Google search yields 1.46 million citations. Not all the information, of course, is helpful or relevant, but there's certain to be a bounty of information that far exceeds what you could have uncovered 40 years ago.




Suppose you enter the search phrase "antithrombin III" into your Google search. Citations: over 900,000. (The number of search citations, in fact, exceeds the number of Americans with a deficiency of this blood clotting protein!)

The same is true with heart disease. There was a time, not more than 30-40 years ago, when information about the heart and heart disease was hard to come by. The most you would find were superficial discussions about heart attacks, what chest pain means, descriptions of bypass surgery. Ask your doctor, you'd likely receive a brief, cursory response about how you probably shouldn't worry it.

Even during medical school in the 1980s, I remember struggling to get answers to my questions from faculty during medical school and medical training. It was as if providing too much information would eliminate the advantage superiors wielded over trainees.

The same selfish sentiment, the "I know something you don't know" mentality reminiscent of a schoolboy's "naa na na naa naa!" unfortunately persists. But it is rapidly disintegrating. Soon it will join the junk heap of medical mis-information accumulated over the years (a big pile, to be sure). The internet and, I'll admit (grudgingly), the media, have been responsible for demystifying the formerly mysterious and indecipherable world of health.

You now have, at a moment's disposal, access to an extraordinary array and breadth of health information that was inconceivable just a few years ago.

Times are changing. Doctors no longer hold the monopoly over health information. The public--YOU--are rapidly becoming the arbiters of health, the informed consumers of a soon-to-be retail product called health care, and the increasingly savvy judges of what should join the mainstream path of health. It is all part of this wave of change that I've been advocating: the emerging concept of self-empowerment in healthcare.

Added to the junk heap of health-mistakes-of-years-past will be medical protectionism over health information, heart procedures, drug industry excesses, nutritional mis-information, among others. The demystification of health information will open the floodgates of individual insight into health. It delivers control over your own health destiny straight into your own lap.

Everything has omega-3

Walking the supermarket aisles, you may have lately noticed that numerous new products are appearing sporting "omega-3s" on the label.

Some products simply contain alpha-linolenic acid, a tiny amount of which is converted to the biologically active omega-3s, EPA and DHA. Natural Ovens' Brainy Bagel, for instance, carries a claim of "620 omega-3."



I find this confusing and misleading, since people will often interpret such a claim to mean that it contains 620 of EPA and DHA, similar to two capsules of standard fish oil (1000 mg capsules). Of course, it does NOT. I find this especially troublesome when people will actually stop or reduce their fish oil, since they've been misled into thinking that products like this bread contain active omega-3 fatty acids that yield all the benefits of the "real stuff."


Other products actually contain the omega-3, DHA, though usually in small quantities. Breyer's Smart with DHA is an example, with 32 mg DHA per container.


I find products with actual DHA (from algae) a more credible claim. However, the Center for Science in the Public Interest (CSPI) has looked at the actual contents of DHA in some of these products and found some discrepancies, including amounts of DHA less than the labeled amount and claims of omega-3 wihtout specifying DHA vs. linolenic acid. (It's probably linolenic acid, if it's not specified.)

All in all, the addition of DHA to food products is a nice way to boost your intake of this healthy omega-3. However, keep in mind that these are processed, often highly processed, foods and you will likely pay a premium for the little boost. For now, stick to fish oil, the real thing.

For a brief summary of the CSPI report and a link to the Nutrition Action Newsletter, see Omega-3 Madness: Fish Oil or Snake Oil.

Are cardiologists the enemy?

I'm sitting at dinner with two colleagues. One is a cardiology colleague, another an internist who, in addition to practicing general internal medicine, also takes heart disease prevention very seriously. He has, in fact, participated in the Track Your Plaque program and dropped his heart scan score substantially.

"Why don't we see you in the cath lab much?" my cardiology colleague asked me. He was puzzled, since he knew my background in cath lab work from years before, spending day and night doing procedure after procedure. He spends virtually all his days there.

"Well, my patients simply don't have events any more. Heart attacks and angina among people in my program are just about non-existent. They don't have symptoms and they don't have to go to the hospital. I can't remember the last time that I was woken up in the middle of the night for an urgent procedure for one of my patients."

The internist across the table smiled and expressed his agreement. "That's the same thing I'm seeing: No heart attacks, very few if any referrals to cardiologists for procedures. I remember when it was a several times a week thing. Now, almost never. "

Looking at my cardiology colleague, I saw the usual cardiologist reaction: Eyes searching left and right and behind us for something more interesting. Certainly, talking about a virtual cure for coronary heart disease was just too damn dull.

Such is the attitude of 98% of my colleagues: If it doesn't generate a revenue-producing procedure, why bother? Prevention is for general practitioners, the line of thinking goes. "And anyway, I'm too busy doing procedures! I don't ahve time to talk about prevention and health!" Of course, the poor general practitioner is already overloaded with caring for arthritis, flu, diabetes and all the new drugs for diabetes, headaches, vaccinations, diarrhea, and . . .oh, yes, heart disease prevention.

Are cardiologists the enemy? No, of course they are are not. But they often act like they are. Talking to cardiologists is like going to the car dealer with your checkbook out, pen in hand. The salesman gets to write the check himself and you just sign it. Talk to a cardiologist and more often than not you will end up with a heart procedure--whether or not you need it.

Unfortunately--tragically--they often forget what they are supposed to be doing: Taking care of a disease by preventing it. Putting in a defibrillator is not preventing a disease. Putting in three stents, laser angioplasty, and thrombectomy are not ways of preventing a disease.

I'm thankful for my internist friend who sees the light. Coronary heart disease is a an easily measurable, quantifiable, preventable, and REVERSIBLE process for many, if not most, people when provided the right tools. But don't ask your neighborhood cardiologists to give you those tools.

Are CETP inhibitors kaput?

Was torcetrapib’s crash and burn fatal for this class of drug?

At the 2007 American Heart Association meetings in Orlando, Florida, Dr. Philip Barter of Sydney, Australia, presented an update of the ILLUMINATE drug trial for the once-promising drug, torcetrapib, the billion-dollar bet that Pfizer made on its first entry into the new drug class.

You may recall that the crash and burn of Pfizer’s torcetrapib in December 2006 made headlines and prompted enormous disappointment for many patients and doctors who had hoped for a new drug choice to raise HDL cholesterol. Pfizer executives (heads flew!) and investors were also disappointed, anticipating release of a drug that might have become the number one biggest selling drug in the world—ever, surpassing even Lipitor's® $13 billion annual sales.

Torcetrapib is the first among the “cholesteryl-ester transfer protein inhibitors,” or CETP-inhibitors, drugs that block the exchange of cholesterol and triglycerides between HDL and VLDL particles and prevent formation of the unwanted small LDL particles. Preliminary efforts suggested that effects were positively enormous.

However, the 15,000-participant trial was abruptly terminated after 550 days when an excess of deaths were identified among the group taking the experimental drug: 59 deaths in control group; 93 deaths in the torcetrapib group.

In addition, cardiovascular events were 24% greater in the torcetrapib group, numbering 373 compared to 464 in the no-torcetrapib group, including a substantially greater number of heart attacks and hospitalizations. Another surprise came in the way of cause of death among some of the torcetrapib patients, with an excess of deaths due to cancers (twice as many in the torcetrapib group), strokes, and infections.

Why the divergence: enormous improvements in cholesterol values, yet increase in adverse effects including more heart attack? Deeper digging by the principal investigators uncovered unexpected distortions of electrolytes like sodium and potassium. They then re-analyzed blood samples from participants on both sides of the trial and discovered that participants taking torcetrapib experienced significant rise in the blood pressure hormone, aldosterone. This, they surmised, also likely accounted for the 4 mmHg average rise in blood pressure among those taking the experimental drug. (This is the same pathway blocked by blood pressure drugs like ACE inhibitors lisinopril and enalapril, ARBs like losartan.)

Simultaneously (what a coincidence!) with the torcetrapib data, investigators at competing drug manufacturer, Merck, reported encouraging data with their version of CETP inhibitor, anacetrapib. In a phase II FDA trial of 589 patients, anacetrapib reduced LDL-C levels by up to 40% and increased HDL-C up to 139%.


Spokesman Daniel Bloomfield, M.D., of Merck Research Laboratories reported that "The favorable lipid effects seen in this study with multiple doses of anacetrapib were significant, and confirm the continued evaluation of the clinical benefits of CETP inhibitors in the treatment of dyslipidemia." Quick to distinguish this drug from torcetrapib’s track record of dangerous effects on blood pressure, he added that "the decreased LDL-C concentrations, increased HDL-C concentrations and no demonstrable increase in blood pressure seen with anacetrapib are particularly encouraging results of this study."

However, the data reported only an 8 week expereince. Given the experience with torcetrapib, longer term data will obviously be required to assess safety. After Pfizer spent over $1 billion and sacrificed lives to obtain this experience, Merck will need to tread carefully.

It will clearly be many years before we have a confident answer on whether the CETP-inhibitor class of drugs will be a safe choice for correction of cholesterol abnormalities, especially low HDL. Are we helpless until then?

Though CETP inhibitors offer the potential for a one-stop opportunity to raise HDL substantially, there are still many strategies available to raise HDL.

Strategies that raise HDL and are available today include:
• Weight loss—to your ideal weight. A very effective strategy.
• Reduction in processed carbohydrates—like breads, pasta, cookies, pretzels, etc. Note that very low-fat diets reduce HDL. Often a huge effect.
• Fish oil—A small effect, more dramatic when triglycerides are high.
• Niacin—Vitamin B3, the best we have at present. Doses of 500-1500 mg per day raise HDL 20–50%; work with your doctor if you are contemplating niacin. We use this agent everyday and have had great success; good hydration is key to minimize the annoying “hot-flush” effect.
• Dark chocolate—40 grams, or about 2 inches square, a delicious way to squeeze out a little rise in HDL.
• Alcoholic beverages—Red wines are almost certainly the preferred route, rich in flavonoids.
• Exercise—HDL-raising effects vary, but can sometimes be as much as 10–20 mg.
• Other drugs—Though not commonly used for this effect, drugs like pioglitazone (for diabetes and pre-diabetes); fibrates (Tricor® or fenofibrate; Lopid® or gemfibrozil); and Pletal® or cilostazol are occasionally prescribed.
• Vitamin D—You won’t find validation of this effect in any scientific study, but our emerging experience in our heart disease reversal program is suggesting that this neglected nutrient can exert powerful HDL-raising effects. In fact, supplementing vitamin D has made my life much easier.


And, last I checked, none of these HDL-raising strategies are ever fatal.

Roto Rooter for plaque




Joe, a machinist, was frightened and frustrated.

With a heart scan score of 1644 at age 61, his eyes bulged when I advised him that, if preventive efforts weren't instituted right away, his risk for heart attack was a high as 25% per year. Joe had "passed" a stress test, thus suggesting that, while coronary plaque was present--oodles of it, in fact--coronary blood flow was normal. Thus, there would be no benefit to inserting three stents, say, or a bypass operation.


(Illustration courtesy Wikipedia)

"I don't get it, doc. Why can't you just take it out? You know, like Roto-Rooter it out? Or give me something to dissolve it!"

Of course, if there were such a thing, I'd give it to him. But, of course, there is not. It doesn't mean that there haven't been efforts in this direction over the years. Among the various attempts made to "Roto-Rooter" atherosclerotic plaque have included:

Coronary endarterectomy
This is a drastic procedure rarely performed anymore but enjoyed some popularity in the 1980s and 1990s. Coronary endarterectomy was performed during coronary bypass surgery, but few thoracic surgeons performed it. Milwaukee's Dr. Dudley Johnson was the foremost practitioner of this procedure (retired a few years ago after his own bypass operation) with a mortality in excess of 25%. A very dangerous procedure, indeed. The technical hurdle, beyond the tedium and length of time required to remove plaque that had a tendency to fragment, was blood clot formation after tissue was exposed upon plaque removal. I saw many lengthy hospital stays and deaths following this procedure.

Coronary atherectomy
This is an angioplasty-type procedure that has gone through several variations over the years.

In the early 1990s, transluminal extraction atherectomy (TEC) was a technique involving low-rpm drill bits with a suction apparatus that was used to clear soft debris, usually from large coronary arteries or, more commonly, bypass grafts. Then came direction atherectomy, in which a steel housing contained a sharp drill bit that captured atherosclerotic plaque in an aperture along the housing length and stuffed it into a nosecone, retrieved once the device was removed.

Then came high-speed rotational atherectomy in which a diamond-tipped drill bit rotated up to 200,000 rpm and essentially pulverized plaque to flow downstream and, presumably, eventually captured by the liver for disposal. Rotational atherectomy is still in use on occasion. Laser angioplasty, usually using the excimer wavelength, vaporizes plaque. I did plenty of all of these back in the early and mid-1990s.

While all atherectomy procedures sound clever, they are all plagued by the same problem: vigorous return of plaque. Remove plaque, it grows back. There are few instances today in which atherectomy is still performed.

Chelation
This involves a metal-binding, or "chelating," agent like EDTA normally used in conventional practice for lead poisoning. Usually administered IV, some have also advocated oral use. People who use chelation also tend to believe in faith healing and other practices based on faith, not science. There is an international trial that is nearing completion that should provide the final word on whether there is any role to intravenous chelation.

There are numerous other oral treatments that claim a Roto-Rooter-like effect. Nattokinase, for example--an outright, unadulterated, and unqualified scam.

Unfortunately, the helpless, ignorant, and gullible are many. When frightened by the specter of heart disease, there are plenty of people who will willingly pay for the hope provided by clever ads, fast-talking salespeople, and unscrupulous practitioners.

So, Joe, there is no Roto-Rooter for coronary atherosclerotic plaque, at least one that is safe, doesn't involve a life-threatening effort, provides results that endure beyond a few months, and truly works.

The Track Your Plaque program may not be easy. There are obvious common hurdles to adhering to these concepts: obtaining lipoprotein testing, getting intelligent interepretation of the results, persuading your doctor to measure vitamin D blood levels, battling the onslaught of prevailing food propaganda that confuses and misleads. The Track Your Plaque program also requires time, at least a year.

But it's the best program there is. Do you know of anything better?

"Beware nutritional supplements"



In our effort to expand the reach for the nationwide conversation on heart disease reversal, I'd like to welcome the newest contributor to the Track Your Plaque family, a new Member blogger, Heart Cipher.

We first came to appreciate the insights of Heart Cipher on our Member Forum. His curiousity and ability to cut through the bull--- have won over our hearts and minds. I think you will appreciate his unique perspective as someone who has experienced first hand the inadequacies of the present procedure-focused, drug-obsessed standard of medical care that dominates, yet has the intelligence and worldliness to recognize that there are better ways.

Read his post about meeting a new cardiologist for the first time and the reaction he receives when he describes the Track Your Plaque program here.

http://www.heartcipher.com/

The rules of reversal


For the last few years, most practicing physicians have followed a rough blueprint for cholesterol management provided by the Adult Treatment Panel-III “consensus” guidelines, or ATP-III, a lengthy document last released in 2001, updated in 2004.

For instance, ATP-III suggests reducing LDL cholesterol to 100 mg/dl or less for those deemed to be at high risk for future heart disease, arbitrarily defined as a risk of 20% over a 10-year period. It also suggests that a desirable triglyceride level is no more than 150 mg/dl. The ATP-III guidelines have been the topic of discussion in thousands of medical meetings, editorials, and reports. They have served as the basis for many dinners at nice restaurants, weeks in Vegas or Honolulu, many, many lunches catered by pharmaceutical representatives. For most internists, family doctors, cardiologists, and lipid clinics, ATP-III is the Bible for cholesterol management.

AT-III has also become the de facto standard that could conceivably held up as the prevailing "standard of care" in a court of law in cases of presumed negligence to treat cholesterol values. “Doctor, would you agree that the consensus guidelines issued by the National Institutes of Health and endorsed by the American Heart Association state that LDL cholesterol should be reduced to 100? You do? Then why was Mr. Jones’ LDL not addressed according to these guidelines?”

Who was on the ATP-III panel and on what scientific evidence were the guidelines based? Several problems:

1) Of the 9 physician members of the panel, 8 had ties to industry, some of them quite intimate.

2) The studies upon which the guidelines were based and figure prominently, such as the Heart Protection Study, PROVE IT, and 4S, were all funded by the pharmaceutical industry. Of course, it would be unreasonable to expect anyone other than the pharmaceutical industry to fund drug studies. But prominently neglected or understated in the guidelines are all the other insights and treatments for coronary atherosclerotic risk available that were NOT funded by industry.

Of course, there’s money to be made in reducing LDL cholesterol. Lots of it--$23 billion last year alone, in fact. Just keeping that fact in mind makes the ATP-III guidelines make far better sense.

ATP-III is really not a blueprint for heart disease prevention. It is a blueprint--by industry, for industry--on how and when to treat LDL cholesterol.


But what if ATP-III had been a map for navigating coronary plaque reversal instead? What if it were not obsessed with just reducing LDL cholesterol, but was focused on providing the corner internist, family doctor, or cardiologist a roadmap for navigating the highways and byways of reversal?

That would be interesting. Mainstream reversal. Imagine that.

Among the difficulties is that the path to reversal is not lined with deep pockets. Treat LDL and who gains? That's easy. Reverse heart disease and who gains? Beyond LDL reduction, very few (beyond you and me, of course).

That’s why the call for a new Age of Self-Empowerment in healthcare is necessary now more than ever. In my view, in the foreseeable future, we will not have an ATP-III-like blueprint for heart disease control or reversal, nor will we witness a boom of nationwide appreciation that coronary atherosclerosis is a reversible process.

It’s time to take the control back and put it in our own hands. Don't expect the American Heart Association to do it. Don't expect the pharmaceutical industry to do it. If there's anyone who's going to do it, it's YOU.

Incurable wheataholics

Greg slumped back in his chair.

"I'm sorry, doc. I feel like the world's biggest schlump!"

He was referring to the fact that he had gone wheat-free for two months--eliminated all breads, bagels, donuts, pasta, breakfast cereals, crackers, pretzels--and promptly lost 30 lbs. He felt great, discovered new levels of energy he thought he'd lost long ago.

Then some friends convinced him to have some cheeseburgers at a fast food restaurant.

"After that, it was downhill. I couldn't get enough. My wife made chile and I had to have four slices of bread with it. Then I'd have two more. I just couldn't stop."

Now, having regained the 30 lbs in the space of another two months, Greg was expressing his disgust.

And it's not the first time. Greg has struggled with his wheat-alholism for as long as I've known him. I've tried motivating him by showing him the flagrant lipoprotein patterns that his wheat habit and excess weight caused: markedly elevated LDL particle number, severe small LDL, low HDL, high triglycerides, high C-reactive protein, high blood sugar, high blood pressure. Greg has received a total of 7 stents over the past 5 years. His next stop is the operating room for a bypass if he can't bring his patterns and impulses under control.

But for some reason, Greg seems to always return to the wheat trough, gorging on breads, pretzels, cake, often in great quantities.

I'm not entirely sure what to do with someone with Greg's severe degree of wheat-aholism. I view wheat-aholism as similar to alcoholism. For some, it can be as addictive.

The only strategy that I know can work is to make a clean break and drop wheat products altogether. Just as an alcoholic cannot just satisfy him/herself with a drink or two a day, so a wheataholic can't be satified with just a couple of wheat crackers. It inevitably leads to the avalanche of wheat indulgences.

Perhaps we should form a new group: Wheataholics Anonymous. "Hi. My name is Greg and I'm a wheataholic."

The battle for asymptomatic disease

The heart disease revenue pie is shrinking. So is the "serving size" being shared by competing hospitals.

In other words, as more hospitals open heart programs, there is more competition for the same heart patient. Throw into the mix the drop in "acute" presentations of disease, probably due to the now widespread prescribing of statin drugs. When I first started cardiology practice 15 years ago, for instance, days and nights spent taking care of heart attacks coming through the emergency room was a common event. It still happens, but far less frequently. (I don't mean to suggest that the actual prevalence of coronary heart disease has decreased, just the acute, catastrophic version of it.)

Throw into this mix the results of the COURAGE Trial that has put a damper on the value of stents and angioplasty vs. "optimal" medical therapy in people with stable anginal symptoms, since there was little advantage of procedures. Though it has not stopped the practice, it has reduced the enthusiasm for procedures. Though data are hard to come by, I've heard talk of 10% or greater drops in total procedural volume over the past year.

It's not uncommon for hospitals to have overbuilt heart facilities in anticipation of continued growth of this--until recently--growth industry called heart disease. However, factors are converging that may provide a new profit opportunity for hospitals.

One such opportunity is CT coronary angiography. The usual scenario: Man or woman without symptoms is persuaded somehow--an ad, primary care physician, next door neighbor with a scary event, Dr. Mehmet Oz gushing about this sexy new technology on yet another Oprah episode--to undergo a CT coronary angiogram. A "severe" blockage is found, despite the lack of symptoms, and voila! A stent patient or bypass patient is created out of nothing! Do this repeatedly and systematically, and a hospital can regain its former high-procedural volume glory.

Heart scans, though I believe deeply in them and they are the basis for the Track Your Plaque prevention and reversal program, can also be used and abused this way. Asymptomatic person has a score 150. Concerned, they go to their physician who orders a nuclear stress test. An "inferior perfusion defect" is seen, presumably representing poor flow through the right coronary artery (but often just means that the diaphragm overlaps the heart muscle and yields this apparition, a "false positive" or misleading result). "But--wink--we've got to find out if there's a severe blockage, don't we? You don't want to end up in an early grave!"

Thus, the battle for new patients with asymptomatic disease is getting underway in earnest. The scramble for cardiologists to learn how to use CT coronary angiograms is proceeding at breakneck speed, with new training courses being offered nationwide several times and places every month. CT coronary angiography is a useful test, but it is also subject to enormous abuse. It also provides the ticket for the unscrupulous physician and the revenue-hungry hospital eager to expand its patient volume.

Many people believe that this cannot happen commonly in 2007, given scrutiny of practices, litigiousness, and the expectation of a moral sense in medicine. However, I've witnessed such incidents several times this month alone. If you need graphic proof of just how far this can go before action is taken, read Coronary, Stephen Klaidman's chilling tale of a cardiologist and cardiothoracic surgeon in small-town northern California who built an enormous heart center based on fabricated heart disease diagnoses. You'll also find their story in Shannon Brownlee's recently released Overtreated: Why Too Much Medicine Is Making Us Sicker and Poorer.





Of course, the Track Your Plaque program is meant principally for people without symptoms, also. But we are advocating that asymptomatic disease is a reason for prevention, not procedures. There's a difference.

By the way, the two practitioners who engineered the escapade detailed in these books, cardiologist Chae Hyun Moon and cardiac surgeon Fidel Realyvasquez, walked away with a monetary fine and suspension of their California medical licenses. It is likely that many people died because of their abusive practices, but the state struggled to make a sufficiently persuasive case for reasons that I still don't understand.