Dr. Bill Blanchet: A ray of sunshine 26. June 2008 William Davis (4) Another heated discussion is ongoing at The Heart.org, this one about Tim Russert's untimely death: Media mulls Russert's death as cardiologists weigh in Although I posted a couple of brief comments there, I quickly lost patience with the tone of many of the other respondents. Should you choose to read the comments, you will see that many still cling to old notions like heart attack is inevitable, defibrillators should be more widely available, "vulnerable" plaques cannot be identified before heart attacks, etc. I quickly lose patience with this sort of outdated rhetoric. However, our good friend, Dr. Bill Blanchet of Boulder, Colorado, has a far stronger stomach for this than I do. Here, a sample of his wonderfully persuasive comments:Heart disease cannot be stopped but we can certainly do better!Goals we must achieve if we hope to solve the Rube Goldberg of coronary disease:1. Find something more reliable than Framingham risk factors to determine who is at risk. Framingham risk factors are wrong more often than they are right. If you are comfortable treating 40% of the patients destined to have heart attacks, continue to rely on “traditional” risk factors only.2. Treat to new standards beyond NCEP/ATP-III. These accepted standards prevent at best 40% of heart attacks in patients treated. This is unacceptable, and arguably why Tim is dead today! Why prevention protocols emphasize LDL and more or less ignore HDL, triglycerides and underemphasize blood pressure eludes me.3. Motivate patients to participate in coronary prevention. Saying “you need to get exercise and lose weight” is not adequate motivation, it hasn't worked to date and probably won't work tomorrow. If you are satisfied saying it is "the patient's fault for not listening to me" so be it, that excuse doesn't work for me!Currently “good results” consist of being able to convince 50% of patients at risk by traditional risk factors to participate in prevention and hopefully 30% will be treated to goal. Of those treated to goal, 60% of the heart attacks will still happen anyway. Mathematically we can hope to prevent <10% of heart attacks with this approach!I have personally found a solution to this dilemma. It goes like this:1. EBT-CAC [electron-beam tomography coronary artery calcium] is the most reliable predictor of coronary events period, the end! Anyone who disagrees has not objectively read the literature. The only test more predictive than the initial calcium score is the follow up score 12 to 36 months later. EBT predicted Tim Russert’s event 10 years before it happened; passing his stress test gave him inappropriate reassurance 2 months before he died. If only Tim had the benefit of a second EBT sometime over the last 10 years he and his doctor would have known that what they were doing was insufficient and improvements could have been made.2. I treat to the standard of stable calcified plaque by EBT (<15% annualized progression, preferably <1% annualized progression). This correlates with a very low incidence of coronary events. Even the ACC/AHA 2007 position paper agrees with this. This is accomplished with aspirin, omega-3 fatty acids, diet, exercise, weight control, smoking cessation, treatment of sleep apnea, stress reduction, control of HDL, triglycerides and LDL cholesterol and excellent control of BP and insulin resistance plus the recent addition of vit D-3. Meeting an LDL goal of 70 is easy but prevents only a minority of events, treating to the goal of stable CAC by EBT is a challenge but when achieved, the reward is near elimination of heart attacks and ischemic strokes. This has indeed been my personal experience!3. A picture of plaque in the coronary artery is a monumental motivator for patients to get on board to make things better. The demonstration of progression of that plaque despite our initial therapies gets all but a few suicidal patients interested in doing a better job. I think that similar motivational results can be had with carotid imaging; the difference is that CAC by EBT is clinically validated as being a much stronger predictor of events with progression and non-events with stability than any ultrasound test including IVUS.Wow! I couldn't have said it better. Sadly, I doubt even Dr. Blanchet's persuasive words will do much to convince my colleagues on this forum. And the cardiologists on this forum are likely among the more inquisitive and open-minded. The ones stuck in the cath lab day and night, or implanting defibrillators, are even less inclined to entertain such conversations. While I admire Dr. Blanchet's energy for continuing to argue with my colleagues, the lesson I take is: Take charge of health yourself. If you wait for your doctor to do it for you, you could be in the same situation as poor Tim Russert. This is an age when your physician should facilitate your success, not prevent it or leave you wallowing in ignorance.
The Russert Protocol at work 25. June 2008 William Davis (6) Without a concerted effort at prevention, heart scan scores (coronary calcium scores) grow like weeds. The average rate of growth is 30% per year. Keith is an illustrative case. At age 39, Keith's heart scan score was 29, in the 99th percentile due to his young age. (In other words, young people before age 40 have no business having plaque. If they do, it's bad.)True to conventional practice, Keith's doctor prescribed a cholesterol drug (Zocor), asked him to take a baby aspirin, and prescribed a blood pressure medicine. He asked Keith to cut the fat in his diet. His doctor even exceeded conventional (ATP-III) LDL cholesterol treatment targets. Keith, an intelligent and motivated businessman, happily complied with his doctor's instructions. Eighteen months later, a 2nd heart scan showed a score of 68, representing an increase of 135%, or 76% per year.This is the very same approach that the late Mr. Tim Russert's doctors employed: treat (calculated) LDL cholesterol with a statin drug, treat high blood pressure, reduce saturated fat, take aspirin. It was a miserable failure in Keith, whose plaque continued to grow at a frightening rate of 76% per year. It was also an obvious failure in poor Tim Russert. Further investigation in Keith uncovered:--Severe small LDL--80% of all LDL was small (despite a favorable HDL of 58 mg/dl)--Measured LDL particle number (NMR) showed that "true" LDL was actually about 60 mg/dl higher than suggested by the crude calculated LDL--An after-eating (postprandial) disorder (IDL)--A pre-diabetic blood sugar and insulin--Severe vitamin D deficiency--Very low testosteroneAll these patterns were present despite the steps Keith and his doctor had instituted. It's no wonder his plaque was undergoing explosive growth. The conventional approach to coronary disease prevention is inadequate, more often than not a mindless adherence to one-size-fits-all template crafted to a great degree by drug industry interests and "experts" who often stand at arm's length from real live patients. Keith's "residual" abnormalities are all readily correctable. He has since made dramatic improvements in all parameters. Among the strategies used is a wheat- and cornstarch-free diet that resulted in 12 lbs lost within the first few weeks of effort. If you are on the "Russert Protocol," have a serious conversation with your doctor about the continued advisability of remaining on this half-assed approach to heart disease. Or, consider finding another doctor.
Petition to the National Institutes of Health 24. June 2008 William Davis (2) A petition to the National Institutes of Health (NIH) is being circulated in response to the mis-statement made in an NIH-sponsored study, ACCORD. The ACCORD Trial included over 10,000 type II diabetics and compared an intensive, multiple-medication group to achieve a target HbA1c of <6.0%, with a less intensively treated group with a target HbA1c of 7-7.9%. (HBA1c is a long-term measure of glucose, averaging approximately the last 3 months glucose levels.) To the lead investigators' surprise, the intensively treated group experienced more death and heart attack than the less intensive group. The conclusion suggested that intensive management of diabetes may not be a desirable endpoint and may result in greater risk for adverse events. The petitioners argue that the problem was not with intensive glucose control per se, but the use of multiple side-effect-generating medications. Unfortunately, the ACCORD conclusions give the impression that loose control over blood sugar may be desirable. The petition originates from the Nutrition and Metabolism Society, a non-profit organization seeking to promote carbohydrate restriction. The petition reads:National Institute of Health re: the ACCORD Diabetes Study: "Intensively targeting blood sugar to near-normal levels ... increases risk of death. "This statement is untrue. This study lowered blood glucose levels only by aggressive drug treatment.Preventative measures and proven non-drug treatments are being ignored by the NIH, ADA and many other governing agencies.There is abundant scientific evidence proving a carbohydrate restricted diet can be as effective as drugs in lowering blood glucose levels safely. Many times diet is more effective than medication in controlling diabetes - all without side effects or increased risk of death. I ask that the NIH publicly retract the above statement. It is misleading the public.I also request that the NIH acknowledge the existing science and fund more research by the experts who have experience with carbohydrate restriction as a means of treatment for diabetes.For more info, or to help people with diabetes, please e-mail info@nmsociety.org .Thank you.I added my comment:In my preventive cardiology practice, I have been employing strict carbohydrate restriction in both diabetics and non-diabetics. This results in dramatic improvement in lipids and lipoprotein abnormalities, substantial weight loss, and improved insulin sensitivity. This experience has been entirely different from the heart disease-causing and diabetes-causing low-fat diets that I used for years. I have a substantial number of diabetics who have been to reduce their reliance on prescription medication for diabetes or even eliminate them. In my experience, the power of carbohydrate-restricted diets is profound. However, better clinical data to further validate this approach is needed, particularly as diabetes and pre-diabetes is surging in prevalence. I ask that more funding to further explore and validate this research be made available if we are to have greater success on a broader basis.If you are interested in adding your voice, you can also electronically sign the petition. It is optional, but you can also add your own comments regarding your own views or experiences.
Wheat withdrawal 24. June 2008 William Davis (16) It happens in the hospital every so often: A clean-cut, law-abiding person is hospitalized for, say, pneumonia, kidney stones, knee surgery, etc. Everything's fine until . . . they're running down the hospital hallway stark naked, screaming about snakes on the wall, accusing nurses of trying to kill him, all while yanking out IV's and monitor patches.It's called alcohol withdrawal. Alcohol withdrawal can range from tremulousness and sweatiness, all the way to delirium tremens, the full-blown form that leads to disorientation, seizures, fever, even death. Withdrawal can also be associated with a number of chronically used agents, such as sedatives/sleeping pills, pain medication/opiates, among others. How about wheat?I wouldn't have believed it, but after witnessing this effect countless times, I am convinced there is such a phenomenon: Wheat withdrawal. You'll recognize it in someone who previously ate bread and other wheat flour-containing products freely, then eliminates them. This is followed by extreme cravings, usually for bread, cookies, or cake; profound fatigue; shakiness; mental fogginess; blue moods. The syndrome can last for up to one week. Then, bam! Sufferers of wheat withdrawal report mental clarity superior to their wheat-crazed days, improved energy, decreased appetite and cravings, heightened mood, and, of course, fantastic drops in weight. Why would removal of wheat from the diet trigger a withdrawal phenomenon? I can only speculate, but I believe that at least part of this response is due to a physical conversion from a glycogen (sugar)-burning metabolism to that of a fatty acid (fat mobilizing) metabolism. People who lived in the up-and-down cycle of craving and eating wheat constantly fed the sugar furnace for years and are enzymatically impaired in fat burning; they've been growing fat stores. Eliminating wheat deprives the body of this easy source of glycogen, forcing it to mobilize fatty acids in the fatty tissues. Sluggish at first, people feel fatigue, mental fogginess, etc. Once the enzymatic capacity for fat mobilization revs up, then these feelings dissipate. Could it also relate to the opioid sequences apparently present in wheat? I wasn't even aware of this fact until a reader of The Heart Scan Blog, Anne, left this comment:Wheat protein contains a number of opiod peptides which can be released during digestion. Some of these are thought to affect the central and peripheral nervous systems. When I gave up gluten, I felt much worse for a few days. This is a very common reaction in those who stop eating gluten cold turkey. Dr. BG provides a fascinating commentary on the addictive/opioid aspect of wheat addictions in her Animal Pharm Blog. Whatever the mechanism, I believe it is a real phenomenon. It can, at times, be so overwhelming that about 20% of people who try to eliminate wheat find they are simply unable to do it without being incapacitated. Of course, that might be a lesson in itself: If withdrawal is so profound, it hints that there must be something very peculiar going on in the first place.
The Big Squeeze 20. June 2008 William Davis (5) Some colleagues of mine brought this scary phenomenon to my attention last evening.As insurance and Medicare reimbursement to doctors and hospitals fall (Medicare is enacting a series of substantial cuts, which will be followed by the private health insurers), you would expect the use of hospital procedures to drop. Makes sense, right? Less money paid per procedure, less incentive to do them. Unfortunately, that's not how it's playing out in the real world. Your neighborhood interventional cardiologist or cardiothoracic surgeon is accustomed to a level of income and lifestyle. That lifestyle is now threatened by shrinking reimbursement. True to the Law of Unintended Consequences, rather than reducing use of procedures, diminishing procedural fees are prompting a good number of practitioners to do more. In other words, if each heart catheterization pays less, why not do more of them, along with more stents, pacemakers, defibrillators, and the like? If four heart catheterizations per day pays less, why not do five to make up the difference? Voila! Income protected. Of course, it comes at the cost of more work. But I will give one thing to my colleageus: They are a generally hard-working bunch who rarely balk at 12-16 hours days in the hospital.How do you do more procedures? Easy. Just lower the bar on who to do a procedure on. Use more aggressive criteria for pacemaker implantation. Interpret the always-fuzzy nuclear stress tests weighed more towards abnormal. Use scare tactics: "You never know--that chest pain could be the last warning you're going to have!" Because the criteria for performing procedures is "soft" in the real world, it is easy to bend the criteria any way you want. It's too early to measure the full impact of this unintended consequence of reduced reimbursement. But don't allow yourself to become a casualty in the reimbursement war. Remain vigilant. Recognize that, despite the fuzziness at the edges, there are still rational reasons for performing heart procedures. Always be armed with information and the right questions. Never submit unquestioningly or without satisfactory answers to your questions.
Tim Russert's heart scan score 210. . .in 1998 18. June 2008 William Davis (10) Despite the media blathering over how Mr. Russert's tragic death from heart attack could not have been predicted, it turns out that he had undergone a heart scan several years ago. A New York Times article, A Search for Answers in Russert’s Death, reported:Given the great strides that have been made in preventing and treating heart disease, what explains Tim Russert’s sudden death last week at 58 from a heart attack?The answer, at least in part, is that although doctors knew that Mr. Russert, the longtime moderator of “Meet the Press” on NBC, had coronary artery disease and were treating him for it, they did not realize how severe the disease was because he did not have chest pain or other telltale symptoms that would have justified the kind of invasive tests needed to make a definitive diagnosis. In that sense, his case was sadly typical: more than 50 percent of all men who die of coronary heart disease have no previous symptoms, the American Heart Association says.It is not clear whether Mr. Russert’s death could have been prevented. He was doing nearly all he could to lower his risk. He took blood pressure pills and a statin drug to control his cholesterol, he worked out every day on an exercise bike, and he was trying to lose weight, his doctors said on Monday. And still it was not enough.“What is surprising,” Dr. Newman said, “is that the severity of the anatomical findings would not be predicted from his clinical situation, the absence of symptoms and his performing at a very high level of exercise.”Buried deeper in this article, the fact that Mr. Russert had a heart scan score of 210 in 1998 is revealed. That bit of information is damning. Readers of The Heart Scan Blog know that heart scan scores are expected to grow at a rate of 30% per year. This would put Mr. Russert's heart scan score at 2895 in 2008. But the two doctors providing care for Mr. Russert were advising the conventional treatments: prescribing cholesterol drugs, blood pressure medication, managing blood sugar, and doing periodic stress tests. Conventional efforts usually slow the progression of heart scan scores to 14-24% per year. Let's assume the rate of increase was only 14% per year. That would put Mr. Russert's 2008 score at 779.A simple calculation from known information in 1998 clearly, obviously, and inarguably predicted his death. Recall that heart scan scores of 1000 or greater are associated with annual--ANNUAL--risk for heart attack and death of 20-25% if no preventive action is taken. The meager prevention efforts taken by Mr. Russert's doctors did indeed reduce risk modestly, but it did not eliminate risk. We know that growing plaque is active plaque. Active plaque means rupture-prone plaque. Rupture prone plaque means continuing risk for heart attack and death. Heart attack and death means the approach used in Mr. Russert was a miserable failure. While the press blathers on about how heart disease is a tragedy, as Mr. Russert's doctors squirm under the fear of criticism, the answers have been right here all alone. It sometimes takes a reminder like Mr. Russert's tragic passing to remind us that tracking plaque is a enormously useful, potentially lifesaving approach to coronary heart disease.Who needs to go next? Matt Lauer, Oprah, Jay Leno, some other media personality? Someone close to you? Can this all happen right beneath the nose of your doctor, even your cardiologist?I don't need to remind readers of The Heart Scan Blog that heart disease is 1) measurable, 2) trackable, 3) predictable. Mr. Russert's future was clear as long ago as 1998. Every year that passed, his future became clearer and clearer, yet his doctors fumbled miserably. Copyright 2008 William Davis, MD
Another failure of conventional cardiac care 15. June 2008 William Davis (5) Though Tim Russert was widely known and respected for his political commentary, he will likely be better remembered as an example of the gross shortcomings of the conventional approach to heart disease.Let's face it:Standard heart disease prevention efforts are a miserable failure. A Track Your Plaque member brought this interview of Mr. Russert's doctor to my attention.It appears that his doctor did all the correct conventional things. You know what became of it. In the eyes of the public and of any attorney, or even of my colleagues, no wrong was committed. The blame does not lie with Mr. Russert's hapless doctor. The blame lies on the system that endorses procedures, prescription medications, the blind adherence to dogma dictated by the pharmaceutical industry and FDA, along with a prevailing philosophy of preferring the management of catastrophes to preventing them. Dr. Newman's idea of a solution: Making an automatic defibrillator (AED) more widely available (!!!).How long does this sort of idiocy have to go on? How many people have to die before the system uses the tools that are already available, tools that could have prevented this tragedy and many more like it?If you and your doctor subscribe to the program that the unfortunate Mr. Russert was prescribed and the brainwashing, unthinking nonsense that his doctor follows, you are a fool. Shame on you. You therefore likely subscribe to the same variety of marketing BS that issues from food manufacturers about Cheerios, whole grains, and low-fat diets. Get with the program. Sadly, Mr. Russert is not the first, he's not the last. The tragedies of conventional advice that line the pockets of drug and food manufacturers number in the millions. We're not talking about some obscure, rare disease. We're talking about the number one cause of death in both males and females nationwide. I deeply wish this message could have reached Mr. Russert before his untimely death. We could all look forward to another Sunday morning with his usual incisive, unforgiving probing of the day's political figures.
Tribute to Tim Russert 14. June 2008 William Davis (11) The sudden passing of news giant, Tim Russert, yesterday of sudden cardiac death struck a blow to American consciousness. Perhaps his hard-hitting interviewing style, while making guests squirm, made him seem invincible. But, of course, none of us is invincible. We are all vulnerable to this disease. We should not allow Mr. Russert's tragic death to occur without taking some lessons. The media have already resorted to interviewing prominent doctors for their opinion.Douglas Zipes, M.D., former President of the American College of Cardiology,was quoted in the media:"An automated external defibrillator (AED) could have been a life-saver. AEDs should be as common as fire extinguishers."This is typical sleight-of-hand, medicine-is-too-complex-for-the-public-to-understand sort of rhetoric that is surely to issue from the conventionally-thinking medical people and the press. Instead, let's cut the BS and learn the real lessons from Mr. Russert's needless death. It is virtually certain that:--Mr. Russert ruptured an existing coronary atherosclerotic plaque, prompting rhythm instability, or ventricular fibrillation. --Making automatic external defibrillators (AED) available might have Band-Aided the ventricular fibrillation, but it would not have stopped the heart attack that triggered it. --Though full details of Mr. Russert's health program have not been made available, it is quite likely that he was prescribed the usual half-witted and barely effective panoply of "prevention": aspirin, statin drug, anti-hypertensive medication. Readers of The Heart Scan Blog and members of Track Your Plaque know that this conventional approach is as effective as aspirin for a fractured hip. --It is highly unlikely that all causes of Mr. Russert's heart disease had been identified--did he have small LDL (it's certain he did, given his body habitus of generous tummy), Lp(a), low HDL, pre-diabetic patterns, inflammatory abnormalities, vitamin D deficiency, etc.? You can be sure little or none of this had been addressed. Was he even taking simple fish oil that reduces the likelihood of sudden cardiac death by 45%? --Far more could have been done to have prevented Mr. Russert's needless death. And I don't mean the idiocy of making AED's available in office buildings. I'm talking about preventing the rupture of atherosclerotic plaque in the first place. Far more can be done to prevent future similar deaths amonsince she joins a growing rank of pseudo-experts on vitamin D and other topics, but she provides a good example of how far wrong mainstream information can be. Simple StepsDo Your D!Calcium often gets all the glory when it comes to bone health. But calcium wouldn't benefit your bones much without its partner, vitamin D!Why? Vitamin D helps your body absorb calcium and keeps your bones strong; without enough vitamin D, the bones become weak and brittle, a condition called rickets in children, and osteomalacia in adults. Adults from 19 to 50 need 200 IU (international units) per day, while those from 51 to 70 need 400 IU daily. Those over 70 need 600 IU per day.Unfortunately, not too many foods contain vitamin D naturally. (Tuna and sardines canned in oil are exceptions.) The good news is that many foods are now regularly fortified with vitamin D, including milk, some yogurts, margarines, and cereals. You can check the Nutrition Facts panel on packages and containers to see which products contain vitamin D. It should be listed after vitamins A and C, along with the percentage of the Daily Value that a serving of the food contains. The Daily Value (a standardized amount) for vitamin D is 400 IU, so if your milk has 25 percent of the Daily Value, it provides 100 IU per serving.Your skin can also make vitamin D using sunlight — you need about a half hour of exposure to the midday sun twice a week to make enough. However, because of the increasing incidence of skin cancer in recent years, many experts are wary about recommending sun exposure.So take a closer look at milk, yogurt, cereal, and margarine selections when you're doing your weekly shopping, and stock up on brands that are fortified with vitamin D. Challenge yourself to consume one source of vitamin D at least three days in the coming week! If you cannot eat or do not like any foods that contain vitamin D or are fortified with it, talk with your health care provider ASAP about taking a supplement. Your bones will thank you for it!Let me list the mistakes in this piece: Adults from 19 to 50 need 200 IU (international units) per day, while those from 51 to 70 need 400 IU daily. Those over 70 need 600 IU per day.This is the same non-information that was the advice originally offered by the Food and Nutrition Board based on a best guesstimate due to lack of data. It is clear from newer data that doses required for full restoration of vitamin D are in the thousands of units. (My personal dose for full restoration of vitamin judged by serum levels of 25-hydroxy vitamin D is 8000 units per day.) The information coming from the Food and Nutrition Board is about as good as the information coming from the USDA (you know, that "government" agency meant to represent the interests of ConAgra, Cargill, and Big Farming) and the American Heart Association (that represents consensus opinion from data 20 years out of date and now arm-in-arm with Big Food like General Mills, Kraft, and Nabisco). These agencies and the advice they offer has, over the past few years, become increasingly irrelevant and outdated. It is the Information Age, in which ulterior motives are becoming more readily exposed, yet they still operate by the rules of the Industrial Age and deliver a message that serves their own purposes.Ms. Austin fell for it. The good news is that many foods are now regularly fortified with vitamin D, including milk, some yogurts, margarines, and cereals.First of all, what is a "diet expert" doing advocating industrial foods? Cereals, in particular, are among the worst foods on the supermarket shelves, whether or not they are fortified. Candy bars can be fortified, too; that doesn't make them any better for you. The vitamin D added to these foods is, more often than not, the ergocalcferol, or D2, form that is woefully ineffective. And the dose added is trivial, usually in the 100-200 unit range per serving. The same goes for the milk, an inadequate source that we don't even factor into total intakes because of the low quantity. Your skin can also make vitamin D using sunlight — you need about a half hour of exposure to the midday sun twice a week.Nope. This might be true for a young person below age 30 in a southern environment. It is NOT true for the majority of people in northern climates and anyone over age 30 or 40, since we lose most of the capacity to activate vitamin D in the skin as we age. A deep, dark Florida tan does not necessarily mean that vitamin D has been activated. See A tan does not equal vitamin D. Here in Wisconsin, where, despite this darn cold winter, does enjoy wonderfully warm and beautiful summers, the average vitamin D dose need ranges from 4000-8000 units per day in summer, slightly more in winter. By the way, it is not calcium that is instrumental to bone health. It is vitamin D. Calcium is the passive bricks and mortar of bones, while vitamin D is the bricklayer, the determinant of calcium's fate, the master control of bone health. Calcium supplementation becomes almost immaterial when vitamin D is restored.I praise Ms. Austin for her hard work, trying to help fat Americans lose weight. But please ignore her advice on vitamin D, along with the numbing repetition of this mis-information that will likely propagate from other exercise gurus, dietitians, and pseudoexperts.
A Tale of Two LDL's 15. January 2009 William Davis (10) Kurt, a 50-year old businessman with a heart scan score of 323, had a :--Conventional (calculated) LDL of 128 mg/dl--Real measured LDL 241 mg/dl. Laurie, a 53-year old woman who underwent a coronary bypass operation last year (before I met her), had a:--Conventional LDL of 142 mg/dl--Real measured LDL was 85 mg/dl. (By "real, measured" LDL, I'm referring to LDL particle number in units of nmol/L obtained through NMR lipoprotein testing and dividing by 10, or just dropping the last digit to convert the value to mg/dl. This technique was arrived at by comparing the population distributions of these two parameters, LDL particle number and calculated LDL. This is the gold standard in my view. Similar numbers can be obtained by measuring apoprotein B, direct LDL, or calculated non-HDL, with diminishing reliability from first to last.)In other words, Kurt's conventional LDL underestimated real LDL by 88%. Laurie's conventional LDL overestimated real LDL by 40%. Interestingly, Laurie's doctor had insisted she take Lipitor for a high LDL cholesterol. Her real LDL was, in fact, low to begin with and benefits of a statin drug would be little to none. (Remember, in our Track Your Plaque approach, multiple other treatments are included, such as omega-3 fatty acids from fish oil, vitamin D normalization, and wheat elimination, strategies that yield benefits that others expect to obtain with statins.) Laurie's real cause of her heart disease proved to have nothing to do with LDL cholesterol, but involved lipoprotein(a) and thyroid issues. Kurt proved to have a severe preponderance of small LDL particles--the worst kind of LDL, while Laurie had none--a benign pattern. Then how can anyone make sense of the conventional, calculated LDL cholesterol that is generally (95% of the time) provided? If accuracy can stretch to plus or minus 80% . . . you can't. Conventional LDL is a miserably inaccurate number. The problem is that obtaining a superior number requires a step or two more testing and insight, something most busy primary care doc's simply don't have in the midst of a day filled with arthritis, bronchitis, diarrhea, belly aches, and seborrhea. Yet conventional--I call it "fictitious"--LDL serves as the basis for this $27 billion (annual revenues) industry selling statin drugs. This is meant to be neither an argument in favor of nor against statin drugs. However, it is plain as day that any study designed to reduce LDL cholesterol will be hopelessly clouded by calculated LDL imprecision. A calculated LDL of, say, 143 mg/dl might really be 187 mg/dl, or it might be 74 mg/dl--you can't tell by looking just at LDL. Yet billions of dollars of research and billions of dollars of healthcare costs are based on the treatment of this number. This reminds me of the mark-to-market accounting magic that helped topple Wall Street. I don't think that the statin world is poised for such a huge downfall. But I do see this as a source of enormous dilution of the effects of statin drugs. People who barely stand to benefit get the drugs, while others who might truly benefit are treated inadequately. It provides fuel to the growing idea that reducing LDL cholesterol fails to truly provide benefit. I am no lover of statin drugs nor drugs in general. But I am a fan of knowing the truth. Despite my bashing of the drug industry (and make no mistake: the drug industry is a cutthroat, profit-seeking, do-anything-to-increase-sales industry), I do believe that there is a role for statin drugs (though far smaller than $27 billion per year). But the usual method of selecting people for treatment is pure fiction. The ATP-III cholesterol treatment guidelines? An anemic attempt to apply structure to meaningless values. You and I do not need to subscribe to this sort of non-quantitative nonsense.
Niacin scams 12. January 2009 William Davis (0) In the Track Your Plaque program, we often resort to niacin (vitamin B3 or nicotinic acid) to: --Raise HDL cholesterol--Reduce the proportion of small LDL particles--Shift HDL towards the healthy larger fraction (HDL2b or "large")--Reduce lipoprotein(a), the most aggressive risk factor known But niacin comes with a crazy "hot flush," a warm, prickly feeling that usually envelops the upper chest, neck and face that is, without a doubt, annoying. Around 1 in 20 people simply cannot tolerate any amount of niacin >100 mg, while others have no problem even into the 3000 mg per day or more range. (Tolerance to niacin is genetically determined, governed by the rapidity of metabolism to the niacin metabolite, nicotinuric acid.)The niacin flush has spawned an entire panel of niacin-like scams, agents that sound like niacin or may even contain niacin, but exert no beneficial effect whatsoever:Flush-free niacin--I have previously posted on this useless but ubiquitous preparation that often costs several times more than conventional niacin. Flush-free niacin, or inositol hexaniacinate, does indeed contain niacin, but it is not released in the human body. You simply pass it out down the toilet, where this preparation belongs in the first place. Nicotinamide--Also called niacinamide. While the nicotinamide/niacinamide forms of vitamin B3 can be used to treat B3 deficiency ("pellagra"), they do not reproduce the lipid and lipoprotein effects of niacin. For our purposes, they are useless. Niacin-containing heart-healthy supplements--These are the multi-supplements that contain a little of everything that might be beneficial for the heart, but none at a dose that provides genuine benefit. Don't throw your money away. There's also a prescription niacin, Niaspan, that costs 20-fold more than the best over-the-counter preparation, Sloniacin. Niaspan has yielded hundreds of millions of dollars for the pharmaceutical industry. Your money, in my view, is far better spent on Sloniacin (around $12-14 per bottle of 100 tablets of 500 mg). For more on niacin, here's an article I wrote for the Life Extension Magazine people a while back: Using Niacin to Improve Cardiovascular Health.
Deja vu all over again? 10. January 2009 William Davis (8) HeartHawk brought a report and debate on The Heart.Org website to my attention: Screening for risk factors or detecting disease? Debate divides the CV community. After landing on theheart.org, paste this onto your URL address:article/883239.do. (Full address: http://www.theheart.org/article/883239.do. I don't know why, but I couldn't go there directly.)Some interesting comments: Dr. Jay Cohn (University of Minnesota):"They're saying that we can't identify disease very effectively so let's just stick with risk factors, which we know are very poorly predictive and nonspecific. It boggles my mind as to why they won't open up their minds to the importance of moving forward in finding better strategies to identify the disease that we are treating. It's very strange. They criticize these disease markers because they are not predictive of events, but they are looking at very short-term outcomes. We're interested in lifetime risk. We're screening people in their 40s who are concerned about morbid events in their 60s and 70s, and no trials are going to track them that long.""You have to accept the pathophysiologic reality that heart attacks don't occur in the absence of coronary disease, and coronary disease doesn't occur in the absence of endothelial dysfunction and vascular disease, all of which now can be identified."". . . Can we as a society and as a profession accept the idea that there is a link between the vascular abnormalities and the events? "And that that linkage is tight enough that it should allow us to accept slowing of progression of the vascular abnormalities as an adequate marker for slowing disease progression, without waiting for events to occur? As soon as you use the word surrogate, people jump up and say we have all these markers that we know don't work well—things like premature ventricular contractions [PVCs] on the electrocardiogram, LDL, HDL—but those are not the markers we're talking about. We're talking about structural and functional changes in the blood vessel and in the heart."Wow. The idea may be starting to catch on. As an interesting aside, Cohn et al use a 10-test panel to screen for vascular disease: "Named for the center's benefactor, the Rasmussen score includes tests for large and small artery elasticity (compliance), resting blood pressure, blood-pressure response to moderate treadmill exercise, optic fundus photography, carotid intimal-media thickness (IMT), microalbuminuria, electrocardiography, left ventricular (LV) ultrasonography for LV volume and mass, and brain natriuretic peptide (BNP). Each test result is scored out of 10 for low, intermediate, or high risk, and the combined results yields a score that Cohn et al believe is more predictive than any of the existing standalone tests."The counterarguments in this debate were provided by Dr. Philip Greenland (Northwestern University), who repeated his oft-used argument that, while he accepts that vascular disease can be identified, no one has proven that measuring it improves outcomes: "We do have that evidence for risk-factor screening. Even though people criticize risk-factor assessment because it is not sensitive enough or not accurate enough, the interesting and curious thing is that we actually have evidence that if you go to the trouble of screening for risk factors and treating them, patients have better outcomes. We do not have that evidence for any of these other tests."An interesting debate ensues that includes Track Your Plaque friend, Dr. William Blanchet, who characteristically argues persuasively in favor of broad screening for coronary disease with coronary calcium scoring:"If we were doing our jobs in primary prevention, we would not need to look at improved intervention and secondary prevention to reduce coronary death."Here's a shock: Dr. Melissa Shirley-Walton, the cardiologist who previously preached the "cath lab on every corner" argument seems to have undergone a change of heart:"What if I walked up to a gentleman and said, "you are at risk for CAD, take a statin", to which he replies, "I'm afraid of those meds". BUT if he sees his calcium score........he is then convinced to be pro-active. What is so wrong with that? What is so wrong with allowing him to spend 250.00 US out of pocket in order to save the US 150,000.00 US later on? No hard endpoints you say with intensive therapy for primary prevention? What about extrapolating from trials for secondary prevention like HATS? ARBITER2? And what exactly is the true definition of secondary prevention? Is it truly primary prevention if we already have intima thickness abnormalities, or fatty streaks? That would more likely fall under secondary prevention by today's new standards. So, I'm all for any visual aid that will encourage compliance with life style change, necessary medical therapy and followup. If the patient is willing to spend 250.00$ to get a calcium score, so be it. Better yet, why not lower the price so everyone can have the option if they are motivated enough to seize an opportunity?"I have to admit that I thought that Dr. Blanchet was wasting his time trying to persuade Shirley-Walton et al, but perhaps he is having an impact, though having hammered away at them for the last year or so. These arguments, for me, eerily echo many previous debates I've heard. But I am encouraged by the more favorable treatment the notion of atherosclerosis screening is receiving. Just 5 years ago, all coronary calcium scoring would have received from the conventionalists is "more clinical studies are needed." So perhaps the cardiology and medical worlds are inching slowly towards broad acceptance of screening for coronary and vascular disease. BUT, screening is not sufficient. What do you do with the information? Here is where the conventional-thinkers stop. The question that seems to occupy them: Perhaps we should screen people for hidden coronary and vascular atherosclerosis so we can better decide who needs a statin drug or a procedure. I would pose a different challenge: We should screen people for hidden coronary and vascular atherosclerosis so we can better decide who needs to engage in an intensive program of disease reversal using natural means and as little medication and procedures as possible. Well, perhaps in time.
Lead to Gold: The alchemy of transforming nutritional-supplement-to-medication 9. January 2009 William Davis (25) Here's a recipe to make hundreds of millions of dollars. Others have done it and you can do it, too!1) Identify a nutritional supplement that works. Find some agent deemed to fall within the broad allowances of the 1994 Dietary Supplement Health and Education Act . However, because this agent is already in the public domain and is essential non-patent-protectable, you may need to develop some patent protectable aspect of its production, application, or encapsulation. This patent-protected aspect may or may not provide genuine advantage, but that's not your concern. Your concern is protecting your investment and providing the appearance of exclusivity. 2) Identify a medical indication for your product. Choose a disease or condition that is likely to yield unquestioned efficacy, e.g., omega-3 fatty acids to reduce high triglycerides in people with familial hypertriglyceridemia (triglycerides >500 mg/dl). While this will restrict your ability to make market claims, it will not restrain your ability to sell or allow use of your agent for "off-label" applications. In fact, there are methods to surreptitiously promote the use of your product for off-label use, such as hiring experts to discuss the science behind your product with doctors who can prescribe your product. Ideally, your product's primary indication will provide a substantial market on its own to justify your investment. However, the eventual off-label sales can be substantial, even outstripping the sales generated through your primary indication. 3) Obtain at least $230 million to pay for the clinical trials required to obtain FDA approval. You will also have to raise the capital to build the business to manufacture, distribute, and sell your product. 4) After FDA approval is obtained, your business is up and running, and distribution begins, start bashing the non-FDA-approved nutritional products that stand to compete in your market. You could point out that only your product has actually passed through the rigorous FDA process. You could make claims regarding purity, potency, "approved by your doctor," etc., whether or not there is any truth behind the claim. 5) Buy that second vacation home in Aspen and the corporate jet you've been dreaming about! After all the risks you've taken, you deserve it!That's it, plain and simple. It is a tried-and-true formula that has been applied many times. It is a formula like this that brought Lovaza-brand omega-3 fatty acids to market, Niaspan brand of niacin, ergocalciferol form of vitamin D, Folbee (prescription combination B vitamins), with a slightly different spin for Synthroid (since the Armour Thyroid it is meant to replace is not a nutritional supplement, but a low-cost, generic thyroid replacement). Whatever you do, don't EVER run a head-to-head comparative trial of your agent versus the nutritional supplement competition. For instance, NEVER compare Lovaza to supplemental fish oil capsules, matched milligram-for-milligram for EPA and DHA content. NEVER compare Niaspan to over-the-counter Sloniacin. NEVER compare Armour Thyroid to Synthroid. You never know what you might find. (Psssssttt! They might be equivalent!) The formula is not a foolproof road paved with riches, however. There have been market failures, as well. Folbee, for instance, is hardly a household name. So there's risk involved, no question about it. But, should it all work out, the payoff can be big, VERY big, as it has been for Niaspan and Lovaza. So, start thinking about how you might follow this formula for:1) Cholecalciferol (vitamin D3)--e.g., for osteopenia, low HDL, or high c-reactive protein2) Vitamin K2--also for osteopenia3) Magnesium--for suppression of ventricular arrhythmias (especially Torsade de Pointes)4) Iodine--for goiter and iodine deficiency5) Vitamin C--for uric acid reductionWho said you can't turn lead into gold?