Diabetes getting you down? How we can help

Diabetes-a sample of what we do to help you

The consequences of uncontrolled diabetes are severe: blindness, kidney failure, increased risk of heart disease, and painful peripheral nerve damage. Today, most practitioners focus treatment on strict blood sugar control. While people with diabetes obviously need to keep their blood sugar down, the real goal of effective control is lowering the risk for damage. This is referred to as microvascular disease (kidney, eye, nerves, intestine, bladder, others) and macrovascular disease (heart, peripheral artery disease, stroke, other).

Unfortunately, the number of people with diabetes, pre-diabetes, and related conditions of poor glucose control have increased—wildly.

Even though more medicine than ever is being given out. We are in an epidemic of diabetes that has not stopped for two decades. A new approach to diabetes recognition and treatment is needed. America is in the midst of a diabetes epidemic. Over the past 20 years, the number of adults diagnosed with diabetes has much more than doubled, and children are being diagnosed with diabetes in alarming numbers. Diabetes has also caused an epidemic of heart disease, and keeps the kidney dialysis centers busy.

Blood glucose causes damage through a process called glycation, the same process that causes food to brown in an oven. When you cook sugar in a pan, it will become brown caramel.  After more cooking it will become sticky. Glycation (defined as sugar molecules reacting with proteins to produce nonfunctional structures in the body) is this process combined with proteins, leading to deposits and disruption of key parts in tissues. Proteins become disfigured and destroyed, causing nerve damage, heart attacks, kidney disease, slow bladders, cognitive and memory loss, blindness, intestinal problems, and more.

Oxidative stress is also a central cause of the damage caused by diabetes. Diabetics suffer from high levels of free radicals that damage arteries throughout the body, from the eyes to the heart. Oxidation is similar to biological rusting. When fat becomes rancid, it is because of oxidation. Many scientists recognize that oxidation is one of the fundamental causes of diabetes itself. Diabetics should understand their need for antioxidant assistance to help reduce oxidative stress that is involved in causing diabetic complications.

Inflammation is another common problem in diabetes. A protein in the blood called C-reactive protein reflects the extent of inflammation in many diabetics. We target inflammation so it may be reduced, since it too is one of the processes that further diabetes and cause misery.  A condition known as metabolic syndrome affects about 40% of Americans, and poor glucose handling is a central part of the condition. Inflammation is central to metabolic syndrome, which is another of our special interests.

There are tiny structures in cells called mitochondria, often termed the “powerhouses of cells” since it produces energy. In diabetes, mitochondria themselves become ill, and need support. They become deficient in some nutrients, and identifying and correcting their abnormal function—restoring them to health—is one of our goals.

Estimated average glucose (eAG)… something new

Estimated average glucose is a new way to find out how well you are managing your diabetes.

←You can convert your HbA1c numbers to average glucose using this table

How does it relate to A1C?

Hemoglobin A1c is known to most diabetics as a test that tells your average sugar over the 2-3 months before it was drawn. The A1c level is given in a percentage, and many doctors like to keep it below 7, or below 7.5, depending.

Instead of the A1c percentage, which tells how much a blood protein is glycated, the same information is given in “estimated average glucose”, or eAG. The advantage is that eAG uses the same units (mg/dl) as your glucose meters.

90% OF ALL DIABETES CAN BE PREVENTED WITH NUTRITION, LIFESTYLE, AND EXERCISE——this is where we come in…

Diabetes facts:

• Diabetes is caused by abnormal metabolism of glucose, either because the body does not produce enough insulin or because the cells become desensitized to the effects of insulin.
• Type 1 diabetes is caused by an autoimmune reaction that destroys the insulin-producing beta cells in the pancreas. Type 2 diabetes is caused by decreased insulin sensitivity.
• Type 2 diabetes has reached epidemic proportions in America. The incidence of this disease, which is caused by obesity and genetic predisposition, has increased dramatically over the past five years. It is more common among older people than in other segments of the population, although it is also affecting children at increasing rates.
• People with mild to moderate type 2 diabetes should avoid drugs and therapies that increase levels of insulin. Their disease is characterized by elevated levels of both insulin and glucose. Instead, therapy should focus on strategies to increase insulin sensitivity.
• Possible complications in diabetes arise from damage to enzymes and other proteins that impair their function and from resulting damage to blood vessels. The subsequent decreased blood flow, increased vulnerability to oxidant stress, and decreased antioxidant capacity all interact to produce end-organ damage to the eyes, nerve tissue, kidneys, and cardiovascular system.
• Weight is a powerful influence on diabetes. Losing weight is a major goal of improvement.  Fat cells produce a number of their own hormones, and many cause or promote inflammation, leading to complications.
• It’s a lot more complicated than just high sugar levels!

But are there any natural solutions to this national crisis?

A well known medical practitioner, answered this question some years ago: “Nutritional supplements are a must for anyone with diabetes. Vitamins, minerals, essential fatty acids, and herbs are natural compounds that, if used rationally and in a balanced manner, can have profoundly positive effects on blood glucose levels.”

Natural health practitioners, or “naturopaths,”  and homeopathic physicians all feel similarly, noting that alternative remedies can help or support the body use insulin more efficiently, control blood sugar levels, and can ease diabetic complications in many ways.  We address all of them at once, to help you the fastest possible way.

We are experts in natural healing, and use an amazing number of natural products, most you may never have heard about.  They support and unburden the body, giving it an opportunity to heal itself. Many of these substances and products have several specific effects which produce beneficial structural and functional changes in the person with sugar difficulties. For the most part, they are in the categories below.

These preparations can ease your mind & improve your health

1. Those that support and balance glucose. These help maintain healthy blood sugar levels, allowing you to take back control of your life. There are several of them, and you may not need them all. We combine some of them for your convenience. You can regard them as sugar metabolism tonics to help you steady blood sugar balance, working in harmony with your body to help promote healthy insulin levels.

One particular vitamin in the B family enhances insulin sensitivity and increases the activity of glucokinase, the enzyme responsible for the first step in the utilization of glucose by the liver. Glucokinase concentrations in diabetics are very low. Animal studies have shown that a diet rich in this vitamin can improve glucose tolerance and enhance insulin secretion.

2. Improving insulin sensitivity. There are two or three substances which we use that have been shown to raise insulin sensitivity in experimental situations, and may be very useful. Others actually stabilize the absorption of glucose, and permit easier control, according to many studies.

3. Those that delay glycation. One particular form of this natural substance is considered to be the most potent antiaging form because of its ability to enhance glucose metabolism, quench toxic free radicals, and help block formation of advanced glycation end-products (AGEs).

Sugar (glucose) in the blood can bind to proteins, particularly when blood levels are high. This binding causes the formation of AGEs, which accumulate with time and contribute to some of the signs of aging.

4. Antioxidants are potentially beneficial. One specific powerful antioxidant positively affects important aspects of diabetes, including blood sugar control and the development of long-term complications such as disease of the heart, kidneys, and small blood.

It plays a role in preventing diabetes by reducing fat accumulation. In animal studies, this remarkable substance reduced body weight, protected pancreatic beta cells from destruction, and reduced triglyceride accumulation in skeletal muscle and pancreatic islets.

This particular antioxidant has been approved for the prevention and treatment of diabetic neuropathy in Germany for nearly 30 years. Intravenous and oral forms reduce symptoms of diabetic peripheral neuropathy. Animal studies have suggested that it is more effective when taken with gamma-linolenic acid, a special anti-inflammatory omega-6 fat.

Diabetes also damages deep nerves that control vital organs, such as the heart and digestive tract. In a large clinical trial, people with diabetes who had symptoms caused by nerve damage affecting the heart showed significant improvement without significant side effects from this substance.

5. Those that help biochemical reactions in the body and keep things humming… There are a number of preparations we have that help energy conversion and keep your body tuned. Some have been used to decrease the damage associated with diabetes.

6. Those that help mitochondria function properly. We believe mitochondrial function is one fundamental key to recovery in the body.

In addition to these there are those that support the heart, the arteries, suppress the inflammation associated with diabetes, and those that oppose effects of aging. There are just too many to talk about here, but they are remarkable in that their effects are surprising, and they have no side effects to speak of.

A great number of popular natural remedies have helped many people in their constant struggle to maintain healthy blood sugar levels. When used together, they are synergistic. While there are many more that we use, this gives you an idea of that is available here in this office to help support blood sugar and the potential damage it causes. Knowing which are best for you, how they should be used, and which preparation to turn to, that is our profession, and we do it well.

In summary, support of glucose, inflammation, glycation, oxidation, mitochondrial function are fundamental ways we help you. Remember, it is not just glucose that is too high—the many feared complications include heart disease, stroke, neuropathy, loss of vision, kidney failure, nerve degeneration in the stomach, bladder, and elsewhere (autonomic neuropathy), peripheral artery disease, frequent infections, Alzheimer’s disease, gum disease, and even several cancers.

References are available upon request.

Please call for an appointment to discuss these possibilities,  which ones will help you the most, and get started: 713-790-9191.  Remember, your greatest asset is good health, and knowledge of what is possible is the beginning of happiness.

Rules of eating-a nutrition book on one page

RULES OF EATING-A nutrition book on one page

In response to several emails, we include some food for thought about eating. There are lots more… Help us make the “perfect” list. Email us with your additions (or subtractions) and tell us why, with references or sources, if any. We welcome your comments and opinions!

1. Avoid “mindless eating.” Think about everything you eat.
2. Keep a food diary for two weeks. Review it, ask yourself, “what am I getting out of each of these foods, and how can I improve things.” This automatically lowers your calorie intake 5-10%.
3. Make an appointment with us. Find out what you really need to be healthy—scientifically.
4. Cut down on the amount of food you eat, unless you are really thin.
5. Eat mostly plants.
6. If it was made in a factory, ie, not by God, don’t eat it.
7. Avoid processed meats like the plague-hot dogs, luncheon meat, sausage, almost all sliced deli meat, even if you get it at a meat counter. It’s a bag of toxic chemicals spiked with excess salt.
8. Keep portions of everything other than vegetables moderate or small.
9. Do not buy or eat anything with more than 5 ingredients listed. Most “food” you buy is FAKE!
10. This also applies to supplements—any “formula” with more than a few ingredients, especially “proprietary”—avoid it!
11. Avoid red meat, especially pork.
12. Shop in farmer’s markets. In grocery chains, keep to the periphery. The center aisles of the store are filled with processed food. This means a) fake, b) lots of toxins, c) lots of salt and sugar.
13. Stay away from fast food.
14. The more you prepare food at home, the healthier you will be.
15. Steam, grill, or eat vegetables raw. Grill, bake, or roast chicken, lean meat, fish.
16. The more you eat out, the fatter and sicker you will become. Your cholesterol and inflammation skyrockets when you eat out.
17. Stay away from full fat dairy. Arteries are paralyzed immediately for hours after eating a single fatty meal.
18. Cut down on salt. The American Heart Association recommendations are 1,500 mg salt per day. Read your labels.
19. Cut down on sugar, including high fructose corn syrup. Cell mediated immunity is cut in half for 120 min after a sugar drink (75g sugar).
20. Drink plain, pure water. Give up carbonated and sugary drinks.
21. Go for low glycemic foods. Get our fact sheets “The glycemic index” and our list of high glycemic foods that will give you big belly or thunder thighs.
22. You need 30-40g of mixed soluble and insoluble fiber per day. The best is from vegetables. You need fiber even if your bowels are fine… fiber has lots of functions other than regularity!
23. At a meal, vegetables should be the largest portion, and eat those first.
24. Eat beans (fresh or frozen only) at least 5 times per week.
25. Stop eating BEFORE you are full. Try not to be “full”—ever.
26. Do not eat any “food” that will not rot. The longer the shelf life, the worse it is for you.
27. If a food makes a health claim on a package more than once, avoid it. The more claims and praises, the less you should eat.
28. The same for supplements, especially online. The more claims and promises, the faster you should run away.
29. Eat slowly, and at a table.
30. Eat at least one large salad daily. See our paper “Salads-the art of building a great one”!
31. Eat only one portion of raw, unsalted nuts daily, about 15 medium nuts. No more than this. A handful is 2 to 4 portions.
32. Preferred fruits are cherries, dark grapes, kiwi, plums, pears, papaya, mango, and apples.
33. Avoid juices, commercial drinks, punches. Exceptions include a very few highly concentrated juices, hard to find.
34. Eat a rainbow of bright and deeply colorful produce.
35. Keep your weight in range and steady.
36. Learn about “energy dense” foods, which put on weight and have few nutrients. Instead, look for “nutrient dense” foods that contain high amounts of nutrients you need, instead of empty calories. Very important in healthy diets.
37. Divide your food intake this way
38. Exercise! Walk at least 1 hour daily, in addition to that. If you don’t have time, walk to do your errands.
39. To lose weight you need to cut down what you eat. Don’t expect to lose weight just from exercise. You will need OVER 1 hour of STRENUOUS exercise EVERY day to do that!
40. DON’T EAT: candy, donuts, pastries, sodas, canned soups, canned beans, shakes, crackers, cookies, sweetened breakfast cereals, instant rice, instant grains, frozen fried or breaded foods, white bread or anything made with white flour, anything made with shortening, salad dressings other than olive & vinegar.

For customized dietary, nutritional, supplement advice, call us for a consultation. For general nutrition comments, please visit http://healthscienceresearch.com/?cat=119

For information about weight loss programs, visit http://healthscienceresearch.com/?cat=97. For maximum effectiveness, these programs are all customized to fit your own metabolic needs.

For more Food & Weight info, click on the tab below >Resources & Links<  or just go directly to http://healthscienceresearch.com/?cat=109

For Diets, go to Diets under >Resources & Links< or directly to http://healthscienceresearch.com/?cat=120

Prevention works—tips for success. A serious appeal

Is prevention a fantasy, or the future of medicine?

The evidence tells us that true prevention works better than drugs, and lasts longer than surgery—but only if you do it. And that seems to be the problem—doing it. Despite the huge numbers of “diet—exercise—live right” articles in magazines and newspapers, most people talk the talk, but don’t walk the walk.

When many physicians talk about “prevention”, they really mean what they do—vaccinations, screening tests and giving drugs for coronary artery disease, hypertension, cholesterol and triglycerides to “prevent” heart attacks and detect cancer early. For instance, aspirin and statins are given for “primary prevention” of heart disease-the prevention of a first event in patients who are at risk. That’s not just lingo, it’s the point of view. While these measures may be huge advances, critically important, and save lives, some may be band-aids rather than a fundamental solution. An example of the difference is the Texas mandate for insurance companies to pay for screening for calcium and arterial plaque in arteries with CT scans* and ultrasound.  These tests are really good for screening, are evidence-based and underused, but they do not change the prevalence of the problems of fatty deposits in arteries from scratch. Sure, they may identify arterial calcium/fatty deposits for future treatment. Lifestyle changes — nutrition, exercise, stress control, etc. — act in earlier steps, and are disease-modifying, two fundamental advantages in preventing and fighting illness.  *if you discount radiation

Is prevention a myth in this world of multiple medications, scans, and procedures?  Or  is it simply a more rewarding, pleasant, effective, and fundamental way of life to complement such medical management?

When it comes time to change diet and lifestyle—“real” prevention—most doctors now assume it is hopeless, and the patient will not change at all. Even though lifestyle changes are listed first in all treatment guidelines for chronic illnesses, Docs still write the prescription during the initial visit, without bringing up diet. Sadly, they are right! Only 7% of Americans actually lead a preventive life. Most people will not change, some not even attempt it. So in recent years, there have been articles titled “PREVENTION IS A MYTH” in medical journals.

Perhaps too many people do want the prescriptions first… They gladly take the prescription, thinking it is an essential part of the visit.  Yet in just a short period of time, often a few weeks, they stop taking the medication too! In fact, about half eventually stop.  Is there any sense to this sequence?

Could their increased risk for disease be related, for instance, to double or triple cheeseburgers and fries, or prime rib, a box of cookies, all with the fat they contain paralyzing arteries for hours after being consumed? Or huge amounts of salt eaten throughout the day, every day?  Or perhaps six sugary drinks every day that put on weight, leech calcium out of bones, and inflame the body’s cells? Some kids  think that they are eating “vegetables” because they put ketchup on a paper-thin piece of iceburg lettuce in their burger! Most people either don’t want to hear it, or let it roll off.

The scientific basis for prevention is substantial, strong, and current

This past year there have been dozens of papers in medical journals that have conclusively shown that when people try to make healthy choices, they can succeed. Just doing the basics in small steps makes a big difference in their risk for chronic disease-strokes, heart attacks, thinning of bones, cancer… all reduced by large numbers. How about extending your life by up to 70%?  Sound good?

In April, 2009 a report from Harvard Medical School reported that 90% of diabetes could be prevented by attention to 5 simple health habits. For each lifestyle factor corrected, the incidence of diabetes fell by 35%.

The following month on May 20, in the Journal of the American Medical Association (JAMA),   it was reported that people with low fitness ratings had 40% higher risk for death from any cause, and 47% higher risk for cardiovascular disease. Adequate exercise (also called “physical activity” so people do not become frightened or paralyzed by what they should be doing) is grossly under-appreciated, under-rated, and under-used as a non-pharmaceutical means of treating common degenerative disorders of lifestyle.  Increased activity alone may be as effective (or more so, in terms of multiple effects) as approved drugs and other methods of preventing and/or treating depression, diabetes, cardiovascular disease (including coronary artery disease, hypertension and stroke), breast, colorectal and other cancers, and cognitive disorders. The program Exercise is Medicine®, endorsed by the American College of Sportsmedicine, is a most significant positive step in the public interest.

In July, 2009, the Journal of Nutrition found that if you eat a healthy diet, you are likely to live longer. Surprise! This was a huge study from the National Cancer Institute, involving 350,886 participants in a National Institutes of Health/AARP data base.

And in July, JN’s sister publication, the American Journal of Clinical Nutrition, a Tufts University study showed that women who followed the Dietary Guidelines for Americans, which have been criticized as minimal and imperfect, enjoyed slower progression of coronary artery disease (hardening of the arteries).

The August 10, 2009 issue of the Archives of Internal Medicine described how just four simple healthy habits cut the risk of diabetes by 93%, heart disease by  81%, stroke by 50%, and cancer by 36%. But if you added vitamin D and calcium, according to a second release, you could drive cancer risk down over 60%. One executive in a cancer organization claimed 85%. Practicing 5 healthy habits would save well over 100,000 lives per year.

There are many more publications, and they all tell the same tale: the documented basis for simple nutrition and lifestyle advice to prevent chronic disease is startling. But is all this evidence getting people to act and change?  No.

In this past year it was also found that 9% of the national health budget is used for complications of overweight and obesity. And all this excess weight drives diabetes and related conditions, such as metabolic syndrome and prediabetes, which have been rising at about 5% yearly. Right now, about 45% of our population qualifies for the term “metabolic syndrome” and it probably rises by the day. In fact, progress in extending life expectancy in other areas, such as smoking, is being wiped out by the obesity epidemic.

Diabetes was the subject of a special diabetes issue April 15, 2009, of the JAMA, with a notable discussion about the public health problem it poses. In December 2009,  Diabetes Care, a major journal of the American Diabetes Association, published a paper concluding that diabetes will nearly double in the US in the next 25 years and the cost of treating it will almost triple—to $336 billion in 2007 dollars. That assumes obesity and overweight will continue afflicting about 65% of Americans, which is doubtful.

Good grief, is all this overwhelming, or what? What do we need to wake up? And it is just only a sample of the overall problem crushing us. If this continues, Americans are destined to become a country of invalids, medically dependent and care-needy. In addition, with a new health care system in place or not, we will inevitably become bankrupt soon if some major change does not occur. The answer lies not in more approvals for drugs, or expansions of “indications,” simply because drugs are not that effective for lowering prevalence rates of chronic disease, and may cause even greater dependence and expense. The proposal to give entire populations a “polypill” containing 5 cheap drugs, in part to neutralize poor lifestyle habits, is laudable but culturally embarrassing and only a crutch.

What is the answer, then?

We must strike at, and reverse, the basic cause—our poor lifestyle habits.

In specific conditions, the record of change is disappointing. The diets of patients with coronary artery disease remain poor one year after the initial diagnosis.  Even worse, the diets of patients who undergo coronary artery bypass surgery actually grow more likely to deposit fat in arteries (atherogenic) during the year after their procedure, despite dietary advice. In other words, after undergoing a procedure which is a major life event, their diets get worse.  Could it be that some post-operative heart patients then think, “now I’m fixed, so I can eat anything I want?” As Arnold used to say, they’ll “be back”.

As far as specific nutrients are concerned, Americans are also losing the battle to keep their intake and blood levels up to the minimum required to prevent disease, and failing horribly to bring them up to the amounts needed for optimum health. There are no better examples than fish oil and vitamin D, with multisystem, well proven benefits both in prevention and treatment of many diseases, all supported by a tsunami of papers in respected peer reviewed medical journals in the past several years. Both are seriously underused and undervalued. In fact, fish oil has been called a “polypill” itself with respect to disease prevention.

Nutrient inadequacies are not corrected by drugs-they are entirely different approaches, and not “competitors”

Many women in this country are taking medications called bisphosphonates and estrogen to treat conditions such as osteopenia, osteoporosis, and recurring fractures due to thinning of their bones. The purpose of these drugs is to replace insufficient bone mass. Surprisingly, while the package inserts for these medications recommend taking calcium and vitamin D, a significant number of women fail to do so, or take only a fraction of what they need. By not supplying the raw materials from which bone is made, they are greatly diminishing the drug’s effect, and defeating their purpose.  The medication does not replace the need for the basic ingredients needed for more bone.  Sometimes the simple, inexpensive, nutritional approach may be critical.

Think of this possible sequence for a moment.  Suppose a woman was taking one of these drugs to increase her bone mass, but failed to take calcium and vitamin D.  After a year or so, when her bone density test showed no improvement, her physician might give her a more potent medication, one that was more likely to have serious side effects…  In this example, the problem was not a biphosphonate that had insufficient “strength”, but rather no raw materials for the biphosphonate she was taking to use.

In heart failure, not only is vitamin D of  importance in causing problems, but micronutrient deficiencies have been known for decades. Back in July, 2001, a review in the Journal of the American College of Cardiology highlighted the problem. Eight years later, October 27, 2009, another paper in the same Journal about mineral deficiencies in heart failure called it an unmet need.  Recurring hospitalizations for heart failure remains an unsolved problem. Many of the micronutrients of value are inexpensive, yet their potential in this lethal disease remains ignored.

Another example is potassium and magnesium balance. Not only are poor intakes of both common in Americans, but contribute to many diseases. Deficiencies in either are generally not detected using conventional blood levels of these ions, simply because the lion’s share is inside cells. Once blood levels become abnormal, there is usually a much greater problem than realized with the total amounts in the body. Both are extremely important in high blood pressure, heart failure, abnormal rhythms, nerve function, etc. Correction of inadequate intakes could affect public health significantly. Most times, the mild acidosis that concerns people, whether true or not, could easily be reversed by raising their potassium intake.

Contrast for a moment the reduction of risk for coronary artery disease of 85% through lifestyle changes, with the reduction of 40% using statin drugs. Compare the benefits of minimal extension of lifespan in heart disease using statin drugs, and the more significant lowering of mortality from all causes reaped after using the Mediterranean diet.  Consider the steep rise in protective high density lipoproteins, “good cholesterol” or HDL, from exercise, fish oil and perhaps niacin, compared to the minimal to modest elevation from the use of some medications.  There is no question statin drugs are valuable when needed, but giving them to the entire population to neutralize consequences of bad habits that lead to obesity, metabolic syndrome and high levels of inflammation may be unwise.

Reflections

Just as JFK asked about what we can do for our country, we must ask ourselves, “What are we willing to do for our own health?” This should be our question, rather than say “Doctor, make me thin/get rid of my diabetes” by magic (despite my sabotaging habits), with society subsidizing the (ineffective) process.  Lifestyle modification, admittedly difficult at first, does not chalk up huge drug bills, one prescription after the other, each eventually abandoned. Lifestyle changes also require fewer tests to monitor whether medications are working, or for potential adverse drug reactions.

Positive lifestyle habit changes needn’t be large, or many. Just a couple of small steps in a positive direction can make a big difference.  Commit and resolve to be healthy!  A positive lifestyle leads to a healthy body and the mental depth to successfully deal with these demanding times.

To begin, commit to prevention—real prevention, on a personal level. Everyone already knows that poor lifestyle habits lead to chronic disease. But most people just want to get the quick fix—the “magic pill”, or surgery, get it covered on their insurance, and go back to their old habits. What they don’t realize is that the quick fix has another price—side effects, and after surgery, more surgery when the problem returns. And it typically does. What comes after heart stents? More stents, until there’s no room left in coronary arteries for additional stents—then bypass surgery. Wonder why?

Does it surprise you that 85% of cardiovascular disease, and over 90% of diabetes is preventable through what you eat and do every day?   Little things certainly do matter.

Not only do good habits cut risk, but when medication and surgery are needed, being in shape helps assure a smooth, successful outcome with fewer complications.

We must also rid ourselves about the notion of the “quick fix.” We must realize there ain’t no quick fix. You’ve got to get light, and quit the chips, pork rinds, processed snacks, and volume eating. Most Americans don’t even know what the sensation of that light diet feel is, and how invigorating when they know the feeling of good health.

This month the American Heart Association advises health, not disease, after seeing 2009’s statistics…

The Annual Report of the American Heart Association will be published in their journal, Circulation, Jan 26, 2010. This traditional review of statistics about heart disease and stroke is, for 2010, being used to revisit the concept of cardiovascular health, rather than cardiovascular disease.

“The AHA is refocusing efforts on lifestyle factors that can prevent the development of cardiovascular disease in the first place, and some of the statistics in this document show us just how far we have to go…”

What to do

The solution: personal responsibility for our own health, trying to make improvements in small steps. Yes, it can be tough, but the reward is great. The power of what we can do together to help our health is awesome, according to a recent N Y Times Editorial.

The bottom line: It’s up to you. People only make changes when they really believe it is in their best interest.

For instance, learn about the Mediterranean-type diet. Despite walls of diet books, it is the only diet proven to extend life, in a most pleasant way. Risks for chronic degenerative diseases are significantly reduced by this diet. Forget about the fad diets, which are usually short on science, but long on claims and naked proclamations.

And best wishes for your program. In future editorials we will offer a list of  important health changes that you can easily incorporate into your routine.  Little by little.

Reproducing this article for any purpose, in part or entirely, requires specific permission.

When it is best to take your blood pressure, and the latest about salt

When is it best to take your blood pressure?

Many physicians recommend taking blood pressure in the evening just before retiring.  In part, this may be due to the belief that nighttime blood pressures are more predictive of future complications and events.  In searching for answers on different web sites, recommendations vary considerably.  So when is best?

Blood pressure elevations should not be neglected

Uncontrolled high blood pressure may lead to heart attacks, strokes, kidney disease, heart failure, ad abnormal rhythms of the heart, including sudden death, and blindness. The further bad news is that over 91% of Americans will develop hypertension in their lifetime, and now about one in three of us have high blood pressure of one type or another.  Even worse, nearly one-third who have it are unaware they do. There are also many misconceptions about blood pressure, some of which are addressed on the American Heart Association site.

Blood pressure generally goes down during sleep, and rises upon awakening. Physical and mental activity and other stimuli raise blood pressure normally—it goes up to provide additional blood flow for activities and is regulated by a complex set of reflexes and hormonal adjustments. The early morning rise in blood pressure does add some risk for a heart attack or stroke at that time. Some people have blood pressures that do not drop by the time they go to bed, and surge excessively in the early morning—they are the ones who have greater risk of premature death.

How to Take Blood Pressures

Measurement of blood arterial pressure is done with an inflatable rubber cuff, standardized for medium-sized arms, and a gauge. The standard mercury column has largely been replaced by other devices, because of the danger of column breakage and accidental mercury poisoning.  For larger arms, a larger cuff must be used, lest the pressure read will be falsely high.  For smaller arms a smaller cuff is necessary.  Failure to do this may result in a falsely low blood pressure reading.  For the same reasons, a blood pressure cuff to take a reading in the thigh must be larger. Measurement of the blood pressure from a cuff at the wrist is not recommended, although recording pressure directly from a catheter in an artery at the wrist does reflect the pressure accurately.

In taking blood pressure, a doctor or nurse inflates the cuff, which momentarily interrupts the blood flow in the (brachial) artery deep in the elbow area, then listens on top with a stethoscope for the appearance, change in character, and disappearance of sound produced by the surging pulse. Unfortunately, many blood pressures are taking incorrectly. And the automatic blood pressures are certainly not infallible–they are just machines. Since major changes in medication are usually based upon just this one reading, an error can cause the doctor to make major, inappropriate adjustments to prescription drugs.

AHA Guidelines call for the patient to be sitting still, quietly, in a chair at least 5 min before the blood pressure is measured, with the arm supported at the level of the heart, not have caffeine, alcohol, or smoke for at least ½ hour beforehand, and have the proper size cuff placed on the skin, not over an irregular piece of clothing. There should be no conversation, no talking on a cell phone, or TV. The area under the cuff should be at least 1” above any bony part of the elbow, firmly seated on soft tissue.  The cuff material should be firmly layered flat, with the final Velcro grip uniform, so that when the cuff is inflated there are no layers that inflate alone, trapping air in a particular area, so that the cuff “bubbles up” in pockets. After inflation, there should be no irregularly distributed lumps and bumps of air, nor material, in the cuff. Cuffs should be deflated at a rate of 2-4 mmHg per heartbeat. A paper in the AMA News last year called for improvement in blood pressure-taking, since the numbers are frequently the only basis for important changes in treatment.  Although the diagnosis of hypertension depends upon high measurements on two to three separate occasions, even a single elevated reading has predictive value. A single high reading should not be interpreted as a clean bill of health, even if two are normal afterwards.  Most of the time, patients tend to “explain away” elevations, and underestimate the seriousness of the problem.

Home blood pressure monitoring is also a useful addition to office visits. While both aneroid and electronic monitors for home use are available, the electronic ones, with both automatic inflation and deflation, are preferred. Wrist and fingertip models are less accurate. Ask your doctor for recommendations, and pre-fit the cuff to your arm size before purchasing. Then compare the machine’s readings to those in your doctor’s office immediately, and at less-than-yearly intervals. Pressures may be taken immediately after arising, 3-5 hours after that, then 2 in the evening. All should be recorded methodically. Once a pattern is established, your physician will suggest the best times to monitor treatment. This will depend upon your lifestyle, exercise, and which type of medication you are taking. Most medications do not last 24 hours, and this works for most people because their blood pressure falls in the evening. A new tool available for following blood pressure is accessible at www.healthvault.com, or at americanheart.org/BloodPressureManagementCenter.

In the May, 2008 issue of Hypertension, The American Heart Association (AHA) and the American Society for Hypertension (ASH) jointly issued a seminal Call To Action On Use For Home Blood Pressure Monitoring, with the full content of the article available  as well.

The presence of office staff when blood pressures are taken may raise it, commonly known as “white coat” hypertension.  For this and other reasons, it is sometimes useful to monitor blood pressures over a period of time outside the office.  To clarify or solidify the diagnosis, ambulatory blood pressure monitoring (ABPM) may be requested. A device is worn for 1-2 days, and includes a cuff which automatically inflates at 15 min intervals while awake and every 30 min at night. Readings are stored, and later transferred to a computer in a doctor’s office. A diary of eating, sleeping, physical activity, emotions, and drugs taken should accompany the recording for best interpretation. Ambulatory monitoring is used to exclude the white coat effect, or help decide whether treatment is adequate.  Although not routine, it has been called the “gold standard” of diagnosis and treatment, and should be done more often. In medicine, generally when measurements are not taken, or less reliable ones are used, the true severity of the condition is unrecognized. When ambulatory BPs are used, a study in the American Journal of Medicine, Dec 2008, showed only 15% of patients being treated had acceptable pressures throughout the day.  Only about 40% of patients taking medications for hypertension have their blood pressures under control, using office and/or home blood pressure readings.

Using ambulatory monitoring, the normal 24-hour blood pressure pattern has been identified as follows:

• BP rises upon awakening, peaks around midmorning, perhaps 10 AM, and decreases throughout the day into the night to reach a trough early the next morning, perhaps 3AM.
• From that point it rises slowly, but the rate that it rises increases upon awakening, perhaps 6AM, as physical activity begins.

Dipping–that’s what blood pressure does…

Traditionally it has been believed that raised night-time readings, or failure to “dip” at night, typically about 10%, may predict cardiovascular complications. But a paper in the journal Lancet (October 6, 2007;370(9594):1219-1229) questioned this conventional view. The authors found that while night time blood pressures were better at predicting premature death. The daytime readings were also good at predicting all cardiovascular events—but not in patients taking antihypertensive drugs. Since most such medications are taken in the morning, by nightfall their effects wane, and blood pressure rises. In any case, when readings are higher at night than in the day, there is a higher risk of death from all causes. The authors concluded that blood pressures should be taken throughout the day.

High blood pressure is classified in stages, as indicated in this table.

A word about salt. Although the debate about whether salt should be restricted for healthy people continues, there is no question that for populations, and as a public health measure, salt intake is much too high, and restriction lowers blood pressures. In fact, excessive salt intake is responsible for about 17-30% of all high blood pressure worldwide. The ill effects of excessive salt intake in relation to the needs of the human body, which are extremely small, is not just blood pressure elevation. Salt intake drives up the incidence of cardiovascular disease, in part because blood pressure elevations amplify and accelerate atherosclerosis or coronary artery disease. A recent paper in the British Medical Journal found that just an extra 5 grams of salt, about one teaspoon, raises rates of stroke by 23% and all cardiovascular disease by 17%.  Another study published in the New England Journal of Medicine confirmed the report, calculating that lowering dietary salt by 3g/day would lower new cases of  heart disease by about 90,000/year, stroke by 49,000/yr, heart attacks by 76,500/yr and deaths from any cause by 68,000/yr. This amounts to between $10-24 billion in health care costs annually, equivalent to 293,000 human life-years!  An accompanying editorial called lowering dietary salt intake compelling, inexpensive, and highly effective. Even just 1g less of salt would produce substantial public health improvements.

In addition, recently a careful and scholarly review of all the evidence concerning salt  prompted the American Heart Association to revise recommendations for salt intake in setting 2020 goals for heart health promotion and reduction of heart disease. Now the current recommendation is a daily intake of less than 1,500 milligrams of sodium (=3.8g of salt), down from a prior recommendation of 2,300mg of sodium (5.8g of salt).  Some of our current fast food and not-so-fast meals easily contain more than this in one sitting. Adhering to this amount is definitely a worthwhile challenge, but a must for anyone with high blood pressure.  Much of the lack of blood pressure control that patients and physicians face is actually due to unrecognized excess salt intake.  The most frequent trigger for hospital admissions in people with heart failure is due to a sudden increase in salt consumption.

Unfortunately, salt is “hidden” in almost all foods we all commonly consume. Yet another reason to prepare foods yourself at home, favor a diet high in fresh vegetables and fruits, and avoid processed, pickled, and canned foods.

Conclusion

A sensible approach, at the outset, is to take your blood pressure at different times during the day, depending upon your schedule. If you work, take a reading in the morning, an hour after you return home, and later in the evening. It should be done at the same time each day, at the same point in your routine. If you are taking medication for your blood pressure twice a day, you may want to take it just before your evening dose, to see how long the first dose kept your blood pressure down. If you have symptoms, then take your blood pressure right away when you have them. Out of interest, a spot check or two at the moment you awaken might be of interest. Your doctor will want to know this initial pattern, to better advise when the next readings should be taken, and perhaps begin or adjust the medication dose and/or timing.  And, please, read labels on every food you pick up at the supermarket before you buy it, keeping in mind the 1500 mg/day ceiling.

Doctors’ neckties spread germs

The dangers of hospital infections are nothing new, but lately doctors’ neckties have received attention as a germ-spreader.  Not only ties, but white coats, pens, scissors in pockets, stethoscopes, and cell phones have all been implicated in the spread of superbugs—even newer, more dangerous varieties of germs. The material on blood pressure cuffs is also in this category. Laptop keyboards, door handles, and coffee cups are loaded with germs. But any clothing, shared equipment, hospital garments, or fixed wallpaper, curtains, etc. may participate in transmission of infections in hospitals, the worst place for this to happen.  In homes, even salt and pepper shakers have been found to be major germ-spreaders. After all, who wants to take all the salt out just to wash the shaker?

One turning point might have been in Dec 1991, when the British Medical Journal published a study reporting that the white coats doctors wore were a source of cross infection from doctor to patient, especially in surgical areas. About 25% of doctors’ coats carried Staph aureus. They also stressed the value of hand washing (see the article on this site, Handwashing—why, when and how in the Health Headlines Archives link to the right of this article).

The idea of your doctor flipping his/her contaminated tie on you as you are being examined or inspected, wafting over some microbes that could wind up in your lung and blood, is not pleasant. This might happen in the office, clinic, or hospital.  Organisms from communities are not as resistant to antibiotics as hospital acquired infections.  Worse, patients in the hospital are more likely to have depressed immune systems that cannot fight bugs well.

Hospital acquired infections (HAIs)  are a major problem, amounting to over 2 million cases and causing some 26,250 deaths per year, with a price tag of over $4.5 billion annually. Since they are, in large part, preventable, Medicare stopped reimbursing  for such complications as of August, 2007.

By 2004, at a time when MRSA infections (staph bacteria that are resistant to usual penicillin antibiotics) were really in the news, almost half of the neckties doctors wore in New York Hospital Medical Center in Queens, a part of the New York Hospital-Columbia Presbyterian Health System, contained potentially harmful bacteria.  Nonetheless, it was believed these bugs were carried from the community into the hospitals and posed no real threat. The results were reported at the American Society for Microbiology conference that year, and CBS carried the story.

Due to the rising incidence of MRSA infections in the UK, notoriously difficult to treat, hospital consultants there were told not to wear neckties in order to help stop the spread of the superbug. Shortly after that, Britain’s NHS recommended that doctors stop wearing white coats altogether, since the coats also spread germs.  The edges of white coats, cuffs and pockets, are well known to be “dirty.”

Many physicians believe that the white coat is a respected, time honored  tradition they are reluctant, even unwilling, to abandon. Others feel that wearing scrubs is too informal, and is disrespectful of patients.

In 2008, the Scottish NHS banned white coats. A year later, the American Medical Association considered a resolution recommending the same, but it has not passed, awaiting further scientific proof.

Evidence suggests that hand washing is far more important in transmitting disease than neckties or white coats.

Economic opportunity abhors a vacuum. A company in Florida  has developed a line of silk neckties that are treated to resist germs, allowing physicians to continue with traditional dress and minimize risk. So far, there has not been much study concerning white coats that have been washed frequently with bleach, or specially treated. 

Meantime, for your own edification, next time you visit your provider’s office, watch how many times hands are washed, and beware neckties that dangle next to your nose, mouth, and eyes. You can be fairly certain that both unwashed hands and unwashed neckties are bacteriologically contaminated.

High cholesterol? A surprising new report from the AHA

The results of the ARBITER 6-HALTS trial, comparing the effects of niacin to the drug ezetimibe (Zetia), on the thickness of fatty plaque deposits in the carotid artery, was released at a special American Heart Association Press Conference in Nov, 2009. Simultaneously, the results were published online in a special release by the New England Journal of Medicine with one editorial about the study, and a second editorial about the use of niacin or ezetimibe (Zetia®) in patients. The Journal did the same with the groundbreaking Jupiter study, another controversial report, last year at the 2008 American Heart Association Scientific Sessions. While seeming to be only a comparison between two pharmaceutical agents in lowering cholesterol, there is much greater significance to this report about niacin for a number of reasons.

The background

Ezetimibe, (Zetia®) was licensed in 2002 on the basis that it lowered levels of LDL, “bad cholesterol”. And it does. However, whether it improves morbidity—clinical improvement in atherosclerosis—or in mortality—remains totally unknown, and now, really doubtful. This seems to be a disconnect between lowered LDL levels and the actual disease process.

We have written about ezetimibe before, in connection with the Vytorin® fiasco, in which there were serious delays  in releasing  the ENHANCE study results, attempts to change data in order to show ezetimibe was in fact effective and other irregularities, sharp differences of opinion, and a call for a congressional investigation. A huge scandal evolved. Curiously, all of it disappeared suddenly with negligible consequences, and PCPs continued to recommend the drug. Ezetimibe has been used, even after it was shown to be of little or no clinical value, for initial treatment of elevations in total cholesterol/high LDL in primary prevention of coronary artery disease, stroke, peripheral vascular disease as a sole agent, and as an add-on with statins, as well as in instances of statin toxicity—and for secondary prevention. All of this without recognized evidence-based support, nor specific approval for any of these applications by the FDA.

Why is this important?

The average person with high blood cholesterol or a mixture of problems with high fats in the blood, known as “dyslipidemia”, may not see how it affects them.  Zetia-Shmetia, who cares? 

The fact is that it matters a lot to patients, if not now, then in the future. For front line doctors, both PCPs and cardiologists alike, statin drugs are prescribed right away (although lifestyle changes can be equally effective, just that few patients actually do this).  There are a number of common situations in which they

• cannot be given (eg, women who may become pregnant);
• cannot be taken; 
• cannot be tolerated (muscle side effects, others);
• do not lower bad cholesterol levels enough alone, requiring another agent;
• have been unsuccessful in raising “good cholesterol” sufficiently, and a change in therapy is necessary;
• may need their doses increased, but in order to avoid side effects, the physician may elect to add another medication insteead;
• are not desired by the patient, who, for personal reasons, has read about the side effects, and requests an alternative.

The doctor then must decide what agent should be added.  One likely one has been Zetia®. However,  when this drug is used, the LDL may decrease, but the question is, is it protecting your arteries, your brain, or your life?  In otherwords, are you being given false hope and reassurance when your LDL reports superficially indicate that you are not in danger? Besides, you are paying money for the drugs, going to your doctor, and following directions… and not getting any return, but believe you are being “treated” successfully.  You see now that this question is, after all, indeed an important one. Especially when the answer is—it is not doing anything for you.

What did this study measure?

This trial measured CIMT, carotid artery media-intima thickness, using  modern computer-driven, imaging techniques with fidelity down to 1/1000th of an inch and superb reproducibility, more sophisticated than in past studies.  And it showed that again, ezetimibe did not produce the desired effect in slowing the progression of fat deposits in arterial walls. On the other hand, patients taking niacin did show significant improvement. CIMT is a surrogate for the atherosclerotic process generally, since patients who have plaques in their carotid arteries tend to have coronary atherosclerosis and the same disease in other arteries.

In an early November, 2009 issue of the Journal of the American College of Cardiology, Dr Justin MS Lee at Oxford (UK) reported that 2 g/day of extended-release niacin, in patients using statins but with low HDLs, reduced carotid wall area by 1.64 mm2 on MRI, compared with placebo.

The report’s surprising findings…

At the American Heart Association presentation Nov 15, 2009, surprising results of this new study were discussed by a distinguished panel. The study, with the full name of Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol: HDL and LDL Treatment Strategies in Atherosclerosis (acronym ARBITER-6 HALTS) was stopped early, not because of safety concerns, but because the situation became obvious. Niacin-treated patients showed significant increases in HDL (good cholesterol), while their LDL and triglyceride levels fell.  At the same time, there was a 1.1 mm2 reduction in carotid wall area during the year of study. In contrast, HDL levels in patients not given niacin, HDL remained the same, without such dramatic improvement in LDL and triglyceride values and carotid wall area actually increased by 1.32 mm2.

Why isn’t niacin used more often?

The problems with niacin and is underuse by practitioners are twofold. First, it has a reputation for producing “flushing”, as well as other annoying side effects that are partly mediated by prostaglandins. Patients become alarmed about these side effects, and practitioners understandably do not want to cause such reactions, nor do they have the time to deal with the discussions the follow.  The fact is that flushing does not occur in most patients, and in those that do have flushing, it disappears after a few days if they continue it that long. There are various methods by which flushing may be minimized. The second is that niacin is also available as a supplement, which may evoke confusion and misunderstanding.

Nonetheless, niacin remains an exceedingly effective and valuable agent in the management of dyslipidemia and atherosclerosis which is underused. As was mentioned on a blog following the AHA press conference, not only in preclinical and pharmacologic data, but “angiographic, IMT, and body count data” now support the use of niacin.

The study reopens a hotly debated issue about cholesterol

By far, the greater significance, as we discussed in a recent review published in Therapeutic Advances in Cardiovascular Disease, while discussing the implications of the Jupiter trial,  is that the use of “LDL” (bad cholesterol) levels as a treatment goal in routine lipid profiles is a problem that few physicians or insurance companies want to know about or acknowledge.

What interests most patients about a medical intervention is whether it produces better outcomes, either improvement in a manifestation of the disease, such as increased ability to exercise, or fewer deaths. Using the scientific method, objective measurements are mandatory. When cardiologists measure LDL however, the LDL number is really a surrogate for these “hard”, end-points that matter. Cholesterol levels, especially in the form of calculated LDL values, is a poor predictor of risk and probability of future cardiovascular events.  It is also not a good surrogate in clinical research nor in face-to-face discussions with patients in offices. Rather, the question is, how irrelevant is it?  Many papers in cardiology journals reiterate the value of “classical risk factors”, but fail to address the elephant in the room that cannot be ignored:  about half the patients with heart attacks have normal cholesterol levels. There are a number of  markers available that are better than calculated LDL, discussed under the title advanced lipid testing.  

Niacin doesn’t lower LDL, so how could it beat a drug that does in preventing atherosclerosis?

What is even more surprising, niacin is not known for lowering cholesterol levels, but rather for increasing them a tad. In fact, even in this study, it did just that.  This alone de-emphasizes the reliance upon the calculated LDL number to assess the severity or risk of of atherosclerosis. Niacin does make LDL particles larger and less atherogenic. It does lower the number of LDL particles, which is desirable. It raises HDL, good cholesterol, which is a huge factor in lowering progression of atherosclerosis that has been recently emphasized. Finally, niacin it lowers triglycerides, an atherogenic property which is quite significant in women.

This does not make sense to the “man in the street”

When placing a study in perspective, I always ask, what would the average Joe or Jane with this problem think if they were suddenly made into a researcher?  Here it is: ezetimibe is a drug that lowers LDL (bad cholesterol). Higher LDL levels are supposed to be associated with worse cardiovascular disease. Niacin is an agent which does not lower LDL.  So how come that giving niacin makes arteries healthier, and ezetimibie makes them sicker–in this case actually thickens the carotid arteries, even as the LDL is lower in those patients?  It is striking that in this report, the lower the LDL in the group receiving ezetimibe, the more diseased were the arteries. Conclusion: something was really wrong with the information about this in the past.

The additional question I would imagine an ordinary person would also ask is,  how come it took several years while a lot of people took ezetimibe, when substantial evidence was already available that ezetimibe just did not do the job?

Reactions to the study began immediately

Within minutes after the announcement, there were 20 or so medical news services that carried special features and extra editions with discussions. MedPage Today featured the presentation just a few hours later in an online bulletin we received.  Sad to say, their summary of lipid therapy was “Explain to interested patients that current guidelines recommend the use of statins for lipid control. If goals are not met on maximum tolerated doses, the recommendation is to add ezetimibe for additional LDL-lowering and niacin, resins, or fibrates to raise HDL.” No doubt this study will be the subject of several hundred articles spinning the paper and discussion to support their own private agendas within the next year.

We will amend this column, actually a mixture of editorial and review, to include some of the commentary in the next few days.

W. Douglas Weaver MD, immediate past president of the American College of Cardiology, agrees with us and with the study, about niacin.  Hard facts tend to convince.

In the press conference video clip about the study, Alan J. Taylor, MD, co-director of noninvasive imaging at Washington Hospital Center, said: “This study establishes combination therapy with statin-niacin is superior to statin-ezetimibe…  prudent clinical practice presently favors avoidance of ezetimibe because its net effect on clinical outcomes is unknown and its relative effectiveness is known to be inferior.” The video clip became inactive soon after the release.

However, within the past few years, right up until about 5:30 PM Nov 15, 2009 when the dialogue began, ezetimibe was not regarded as inferior by many clinicians, as was so clearly summarized in MedPage Today, above.

Daniel Patrick Moynihan said everybody has a right to their opinion, but not to their own set of facts. Spin has its place in the media, and can stretch reports about medicine, but just so far. Evidence-based medicine works, as long as it is not polluted or hijacked.  Zetia®, or ezetimibe, seems to have reached an irreversible nadir in this regard.

Can spin and politics overcome the evidence in this study about ezetimibe’s future, as it did following the ENHANCE debacle?  Quite possibly, because money and politics are powerful, and can make life difficult for physicians and researchers.  A hard lesson—far more can go into the promotion and success of drugs than effectiveness. So the answer might be “partly”. Bloomberg quoted an estimated fall of 20% in Zetia sales as a result of this 3rd consecutive negative study.  A minor fall in prescriptions for Zetia® and Vytorin® might signal the beginning of the downfall of evidence-based medicine, only because it could not be hijacked.

Of interest and concern: two days after the release, the Wall St Journal quoted Raymond Gibbons MD, a cardiologist at Mayo Clinic, recommending the use of statins first, then niacin… and after the patient could “try” Zetia. In effect, Dr Gibbons simply ignored the three studies disproving effectiveness of Zetia (Enhance, SEAS, and now Arbiter-6). How is the patient or Dr Gibbons going to know if such a trial of Zetia is working in his patient? The only way is to do CIMT regularly, and the technique used in this study may not be available. If this is not done, Zetia could make the arterial plaque thicker without recognition. So much for evidence-based medicine.

Over 30% of us have fatty livers-is your liver healthy?

The liver is an essential organ

The liver, the second largest organ/gland in the body, weighing from 3.5-6.5 pounds, is located in the right upper abdomen below the diaphragm. It carries out over 500 reactions doing metabolic work, including the processing of foods, detoxifying waste, producing bile, and regulating signals that control bodily processes elsewhere. The liver can naturally regenerate if some of its cells are left and the fibrous scaffolding is not destroyed. Once fibrosis (scarring) occurs, liver cells have died, the architecture of the liver is disrupted, and ability to regenerate is impaired. Like many other organs, there may not be any noticeable evidence of a problem until 75% of its function is gone. However, if only 25% of the cells remain, it is capable of growing into an entire whole liver. One interesting thing about the liver is that it has two circulations, one of blood, and another of bile, within it. It is also unique in that it is fed by two sources of blood: the hepatic artery and the portal vein, and has two output vessels: the hepatic vein and biliary duct.

Some functions of the liver include:

• producing bile, which helps remove waste,  emulsifies fats in the small intestine to facilitate their digestion, and recycles cholesterol
• producing many proteins that carry other substances in plasma
• breaking down proteins, such as insulin, thereby regulating a number of actions in the body
• producing cholesterol and special lipoproteins needed to transport fats in the blood
• converting excess glucose into glycogen for storage, which can later be converted back to glucose for energy
• converting amino acids to glucose for metabolism, and synthesizing certain amino acids from others
• storing vitamins A, D, B₁₂, iron, and copper
• regulation of blood levels of amino acids, which are the building blocks for proteins
• breaking down hemoglobin – recycling and storing its iron
• converting ammonia to urea in the “urea cycle”, allowing the nitrogen from proteins to be excreted in urine
• clearing  and detoxifying drugs and environmental toxins
• synthesizing proteins involved in clotting, known as coagulation factors
• participating in blood pressure regulation, by synthesizing angiotensinogen, which is converted to angiotensin I by renin from the kidney, then to angiotensin II in lung capillaries. Angiotensin II causes blood vessels to constrict, and also raises levels of ADH and aldosterone, all of which raisesblood pressure.
• secreting albumin, a protein plentiful in the plasma, which defends and regulates water distribution in the body
• filtering particles and antigens from the blood, especially those delivered to it by the portal vein from digested food
• synthesizing special proteins that signal other processes to begin, such as “C-reactive protein”, an inflammatory marker
• protecting against infections—as a participant in the reticuloendothelial system in the body, it contains many immune cells which assist in a number of ways

What is non-alcoholic fatty liver disease?

Non-alcoholic fatty liver disease (NAFLD), a consequence of fat depositing and infiltrating the liver, is the most prevalent kind of chronic liver disease in developed countries. The world-wide incidence ranges from 18-50%, but the average is 30%.  About half (range 21-78%) of all diabetics have NAFLD. Even a greater percentage of the obese—80%–have NAFLD or NASH (see below).  Those people with over 200% in excess of their ideal weight, the morbidly obese, have up to 90% incidence of NAFLD. 

 NAFLD is commonly associated with obesity, insulin resistance, diabetes (type 2), pre-diabetes, high cholesterol, and may be accompanied by elevations in two liver enzymes, called ALT and AST. Fatty livers, even with inflammation, can exist without enzyme elevations, as demonstrated by a study done at Mt Sinai School of Medicine in New York, discussed at a PriMed scientific session in Houston last year.

 As the rates of cardiometabolic risk, obesity, metabolic syndrome, and diabetes climb, with high triglyceride levels and glucose intolerance more common, fatty liver disease has become a silent epidemic.  Among children and adolescents too, it is now a large problem as well, driven by the upswing in childhood obesity. About 40% of those with metabolic syndrome also have fatty livers, but they go undetected until, usually for some other reason, an ultrasound or scan of the liver/abdomen shows the defects in the liver. For this reason, the true incidence may be higher.

The simplest form of NAFLD, steatosis, or plain fatty liver, may stay that way.  Or, it may progress to NASH, inflammation, oxidative damage, death of liver cells, scarring (cirrhosis), or lead to liver cancer. How you take care of it will, in large part, determine what will happen. This is one of those situations in which the choice is largely yours.

Cause of NAFLD (2)

Basically, NAFLD is due to abnormal fat metabolism occurring in obesity and insulin resistance, associated with excess visceral fat and/or other conditions, leading to inflammation.

 A “two hit” model of NAFLD suggests that excessive accumulation of triglycerides (fats) from the diet and those made in the body occurs in liver cells (hepatocytes). Inflammation, with release of small molecules called cytokines, such as TNF-alpha and IL-6, produces “free radicals” that damages (through oxidation, or “biological rusting”) liver cells follows. The ability of the hepatocytes and other cells to respond to insulin fails, otherwise known as “insulin resistance”.  

 The usual pathway for free fatty acid metabolism in the liver is through “oxidation” of small 2-carbon pieces from the fats by mitochondria, called “β-mitochondrial oxidation”. Normally, this process causes the liver mitochondria—the powerhouses of cells which actually do the oxidizing of fats—to release hydrogen peroxide and “free radicals” that have potential to destroy molecules and tissues through oxidation. It may seem odd that mitochondria produce harmful free radicals during their normal work of removing the energy locked up in food for us to use, but it is so. Mitochondria in the liver are the greatest source of oxidative stress by free radicals.

 In NAFLD, the accumulation of fat leads to a chain of events that involve oxidation, ultimately harming liver cells, the “2^nd hit”, in which the mitochondria do not function properly, probably unable to oxidize fats normally. Once such oxidative damage becomes excessive, fat in deposits become oxidized (to form abnormal lipid peroxidation products), mitochondrial DNA is damaged, more reactive oxygen species are released, and cell may die.  

Under the stress of receiving a high load of free fatty acids in the disease called NASH, the capacity of the liver to metabolize them is exceeded, and the surplus fatty acids are converted to triglycerides, which are stored in the liver cell cytoplasm, a condition known as steatosis. Steatosis is the hallmark of NAFLD. Triglycerides also are released into the blood as part of VLDL, a condition known as hypertriglyceridemia. This is easily measured with a blood test, but is usually also reflected by elevated VLDL on advanced lipid testing.  In patients with both NAFLD and NASH, liver biopsies show much higher levels of lipid peroxidation (fats already damaged, or made rancid by actions of free radicals) as compared to normal biopsies. Reference #1 goes into the details in greater length. 

 A vicious cycle begins, with more liver cell destruction, and the oxidative stress causes more antioxidant enzyme and vitamin consumption in the liver. Levels of vitamin E, for instance may be low.  In a series of 36 nondiabetic patients,  the more severe the insulin resistant was, the more oxidation products were found, and the lower the plasma levels of carotenoids (α-carotene, β-carotene, lutein),  and vitamin E (α-tocopherol, δ-tocopherol). Small intestinal bacterial overgrowth accompanies several nutrient deficiencies, which include essential fatty acids, amino acids, and choline (4).  All need attention.

Other causes, or factors which may make it worse for the liver, are some medications and toxins. Since the liver detoxifies most medications, and also environmental toxins, this should be addressed as well. These include, for instance, calcium channel blockers, amiodarone, and statins (liver toxicity). Still other toxic chemicals may cause an acute fatty liver, which follows a different, fulminant course.

In summary there is a) decreased ability of mitochondria to oxidize or burn fatty acids, b) increased delivery of fatty acids to the liver, and c) a problem in exporting triglycerides to the blood as VLDL (very low-density lipoprotein) particles.

Natural history of the ailment -fatty liver is not a benign condition to neglect

Initially there are typically no symptoms, although there may be fatigue or pain in the upper right abdomen. Most instances are discovered either during a “routine” set of blood tests, or a scan or ultrasound is done for other reasons during a search for another symptom or sign.  In the first instance, two “liver enzymes” may be elevated, and in the second, the diffuse distribution of fat is visualized.

Fatty livers are one the three largest causes of raised “liver function enzymes” in teens and adolescents, and the leading cause in adults. Practically, if abnormal liver enzymes are found in someone who is overweight, it is likely due to a fatty liver, especially if that person is a diabetic, pre-diabetic, or has features of the metabolic syndrome. Typically there are chronically elevated glucose, insulin, and free fatty acid (FFA) concentrations in the blood (4). Although NAFLD is considered as the hepatic (liver) manifestation of the metabolic syndrome, from 10-15% of patients are not overweight. An elevated value of low-density lipoproteins, LDL or “bad” cholesterol, may be composed of small, dense LDL particles. This may be due to from an increase in the concentration and/or size, of circulating VLDL. The small dense LDL are more atherogenic than larger particles, which may not be detected by routine lipid profiles. Such changes may be not be present in every patient, but advanced lipid testing might be in order.

 In some people, steatosis, the initial stage in the NAFLD spectrum, remains “quiet” and harmless and does not progress to steatohepatitis. Once the simple fatty liver—steatosis—was considered a benign condition, but not any longer. Steatosis is considered the initial incident necessary in the progression to NASH and liver cell damage. When liver enzymes are elevated, liver cells have been compromised. As mentioned, a simple fatty liver is the “first hit” that initiates inflammation; normally there is little fat in a healthy liver.

 The next stage in progression is NASH—non-alcoholic steatohepatitis, or steatosis with inflammation or fibrosis. NASH is now the most prevalent form of progressive liver disease in the America. An estimated 30% of patients with NAFLD have NASH, but this figure is a few years old. Next, what might be considered a “third” stage of the disease, there is scarring, also called fibrosis.  About half the patients with NASH develop fibrosis. Fibrosis is an expected consequence of inflammation, a form of strengthening tissue that is weakened.  Finally, extensive scarring is called cirrhosis; which eventually shrinks the liver. About 15-30% of people with NASH go on to develop cirrhosis.

Complications of cirrhosis include liver failure, a host of problems in connection with raised pressure in the circulation around the liver, such as bleeding varices (dilated veins), and accumulation of fluid (ascites), and cancer—hepatocellular carcinoma. About 3% of patients with NASH develop liver failure, which is a most unpleasant condition. Anywhere from 1-3% develop cancer. On the other hand, 80% of liver cancer is associated with cirrhosis, but this may be due to other causes, eg, hepatitis. Many cases of cirrhosis who are found in a late stage, without any apparent “cause” by history, are now suspected to have had undetected NAFLD.

In one study of people with biopsy-proven NAFLD, about a third stayed the same, another third progressed, and some got better. The problem is, in which group a given patient will be in is unknown until they progress or not, and then it is too late to do much. Clearly, since there are lifestyle and nutritional means of controlling and reversing simple fatty liver or steatosis, doing something about it might be the prudent road.

Treatment

The current standard of treatment for non-alcoholic fatty liver disease centers around dietary and lifestyle changes to promote weight loss, and sometimes metformin, and lately the off-label use of thiazolidinediones (TZDs) (3), which may improve insulin sensitivity, have been administered to help glucose metabolism. There is therefore limited choice that is “approved”, but many drugs are in the pipeline. The more people with the condition, the greater the pot of gold for the pharmaceutical company that succeeds.

NAFLD is associated with overeating of calories, fatty foods, refined sugar, and number of fast food meals eaten. Therefore, fatty liver is much more an environmental disease than a genetic one. and there are many choices nutritionally, herbally, and use of other natural substances that have the potential to a) help mobilize fat, b) detoxify the liver, and c) “lighten the load” on the liver. Counseling and supporting patients with non-alcoholic fatty liver disease leads to health benefits that are independent of changes in weight.

A new study also shows exercise is important, regardless of whether or not you lose weight. In fact, just exercising for more than 150 minutes per week for three months, or increasing fitness levels, was enough for participants to show improvements in fatty liver disease, with normalization of liver enzymes and other indices of defective metabolism.

The European Journal of Gastroenterology and Hepatology published a study in 2006 also reported in 3 months of nutritional changes along with just two one-hour work-outs per week, fatty livers improved in teens.

The best diet for NAFLD patients, just as with metabolic syndrome, is not the same for everyone. It has to be customized according to the specifics (4). Certainly it would be different from someone with isolated elevations in triglycerides and a low HDL (good cholesterol) than for someone else with a high LDL as well. Replacement of deficiencies must also be specific. Some overall conclusions that have been proposed include: low saturated fat intake, high intake of monounsaturated (MUFA) and polyunsaturated omega-3 fattys acids. There is disagreement about the amount of omega-6 intake, but no one would argue against keeping the omega-3/omega-6 ratio high. Replacement of about 30% of MUFA intake with α-linolenic acid in walnuts lowered total cholesterol, LDL, and improved endothelial function in one study.

Use of a very low fat diet does not appear helpful, but carbohydrate limitation and low glycemic, high fiber foods may be helpful. When high blood pressure or other conditions coexist, adjustments must be made (4). The Mediterranean diet, especially with carbohydrate restriction, also offers advantages.

References

1. Pessayre D, Mansouri A, Fromenty B. Nonalcoholic steatosis and steatohepatitis. V. Mitochondrial dysfunction in steatohepatitis. Am J Physiol Feb 2002;282:G193-G199. Abstract

2. Elfaki DAH,  Bjornsson E; Lindor KD.  Nuclear Receptors and Liver Disease – Current Understanding and New Therapeutic  Implications.  Alimentary Pharmacology & Therapeutics. Oct 2009;30(8):816-825.

3. Wilding J. Thiazolidinediones, Insulin Resistance And Obesity: Finding A Balance. Int J Clin Pract. Nov 2006;60(10):1272-1280.

4. Zivkovic AM, German JB, Sanyal AJ. Comparative Review of Diets for the Metabolic Syndrome: Implications for Nonalcoholic Fatty Liver Disease. Amer Journal Clin Nutr. Aug 2007;86(2): 285-300.  Abstract

Guidelines for heart treatment not followed

Get With The Guidelines® (GWTG)  is a hospital-based, voluntary, quality improvement program established by the American Heart Association (AHA). In the larger view, it is a collaboration involving peer review organizations, medical societies, departments of health, hospital associations, and HMOs to improve the quality of cardiovascular care. The information in full versions of guidelines includes valuable reviews of cause, natural progression of disease, patient assessment, which tests should be employed, how to stratify patients according to risk, various treatments in each group, and the strength of the recommendations. Flow sheets or algorithms also assist healthcare teams in following such proven techniques, therapies, and procedures before patients are discharged. The fundamental premise is that guidelines for care in cardiovascular diseases, written jointly by experts on committees at  the AHA and the American College of Cardiology (ACC), constitute state-of-the-art recommendations for management. If followed, they will result in the best outcomes possible, given the science of the day. Guidelines generate protocols to reduce the number of recurrent events and deaths in patients. A study  published in the Archives of Internal Medicine, Sept, 8, 2008  found that hospitals participating in the GWTG-coronary artery disease program provided superior quality of care for heart attacks (acute myocardial infarction), producing better clinical outcomes.  This paper GWTG basically says, GWTG works.

Are Guidelines Helpful?

Guidelines do not necessarily eliminate individualized treatment for patients—they are simply guidelines, but set forth an important reference and baseline for doctors. They are also valuable in putting together data about treatment for future improvements. One consequence of customized treatment is that, by not following guidelines, there are potentially negative legal implications.

Ultimately, it is the physician who must follow the guidelines. The term “clinical inertia” is frequently used to describe resistance by practitioners to some guideline recommendations. Much of the time, there are identifiable reasons.

On February 25, 2009, the Journal of the American Medical Association published a surprising review which concluded that only 11% of over 2,700 recommendations approved by cardiologists are supported by high-quality scientific testing. Fifty-three guidelines on 22 topics were studied. In other words, according to the authors, evidence-based guidelines relied upon too much low grade evidence, and they called for improvements. The AHA and ACC issued a prompt joint rebuttal, and there were a flurry of letters to the Journal as well. Nonetheless, guidelines are considered a major advance in medical care, are well respected, and certainly are here to stay.

Some examples of what guidelines say

In the coronary artery disease GWTG program for instance, patients are started on aggressive risk reduction therapies, such as cholesterol-lowering drugs, aspirin, “ACE inhibitors” and beta-blockers in the hospital, and receive smoking cessation/weight management counseling and are enrolled in cardiac rehabilitation programs before they are discharged. Underuse of all of these treatments has been documented, even though overwhelming evidence exists backing their use.  Similar guidelines exist for post discharge care in order to reduce risk, prevent recurrence, and improve outcomes.

In patients with heart failure, the most recent April 14, 2009 ACC/AHA Guidelines Update calls for these treatments at different stages, and under appropriate circumstances:

• Treating coexisting high blood pressure and elevations in lipids (cholesterol, triglycerides)
• Controlling “metabolic syndrome”—a risk cluster  of abdominal obesity, hypertension, elevated serum triglycerides, low HDL (good cholesterol), impaired glucose tolerance, and many times other evidence of inflammation with an increased tendency of blood to clot. (Three out of the first five features make the “diagnosis.”)
• Discontinuance of smoking, low alcohol use
• Promoting exercise
• “ACE” inhibitors or “ARB” drugs, beta-blockers
• Salt restriction, diuretics (“water pills”)
• Insertion of implantable defibrillator and/or “biventricular pacing” devices
• Aldosterone antagonists and other drugs (for those with moderate to severe heart failure)
• Heart transplantation

Adherence to guidelines is imperfect by both doctors and patients

There is imperfection in following guidelines, and even when they are followed by physicians, patient compliance may be poor.  As a result, the number of patients actually doing what the guidelines suggest is disappointing.  Many patients have poor control of say, their blood pressure and abnormal cholesterol levels, although performance in both areas seems to be improving steadily. Ranges of compliance among both doctors and patients varies between approximately 30%-65%.

The October 21, 2009 issue of the Journal of the American Medical Association now reports  from 241 hospitals participating in the GWTG program for heart failure treatment. Of more than 43,000 patients treated, 12,565 were eligible for an effective drug that blocks the action of the hormone aldosterone—a means of controlling heart failure. Only about a third of those patients (32.5%) actually received the drug. The indication is “Class I”, meaning useful and recommended.

The best known drug in this class, spironolactone, is generic and inexpensive.  Fear of side effects may be one reason for underuse. A brand name drug, eplerenone (Inspra®), may avoid one of them.  Spironolactone is not “detailed” by pharmaceutical company representatives, and awareness of the drug may wane. Some institutions offer “academic detailing”, providing current information about generic medications to the staff, which might be of help.

Is this esoterica, or is it important? It is certainly signifcant, for both the patient and the public. Not only will the patient enjoy improved risk and outcome, ie, live longer or happier, but the public will enjoy reduced medical expenses. Win-win.

Guidelines are part of evidence-based medicine

Practice Guidelines and a relatively new discipline, outcomes research, are part of an evidence-based medicine movement (EBM) which is replacing the more subjective, impressionistic methods used many years ago, when medicine was a “cottage industry.” At that time, physicians would make a diagnosis, or impression, as well as a treatment plan, based upon their

1. recollection of formal information from books, journals, and lectures
2. personal, professional experience
3. clinical judgment, a variable and difficult to define process of their own information processing.

The problem with this approach, which, incidentally, served the majority surprisingly well for a long time, is that it is not objective or quantitative.  Moreover, a specialist with extensive exposure to patients with a particular disease could not transmit his knowledge in a formal way to other physicians accurately. As research provided more and more data based upon science, and the discipline of statistical analysis advanced, methods of processing the data developed to take medicine into a new era.  At the same time, new experimental techniques, advances in devices, and computerized electronic communication provided additional richness and thrust in the evolution to evidence-based medicine. If, for instance, a professor in Milan had a different opinion about the best treatment for a particular disease than an equally distinguished professor in Tokyo, research could provide the evidence that would resolve the difference objectively, using the scientific method.  When different investigators in many countries report similar findings over a period of time, knowledge advances to the consensus of their reports. In this way, incrementally, medical knowledge constantly moves forward from hypothesis to testing to proof in a continuous process.  As medicine becomes more science than “art”—and the practice of medicine will always involve some art—knowledge advances through research, communication, and learning.

In the 1960s patients with heart attacks, or acute myocardial infarctions, were still hospitalized and put in bed for 3-4 weeks. Some were given Mercuhydrin, a diuretic containing organic mercury. As a resident, I participated in, and ordered those treatments, considered state-of-the-art at the time.  Today they are known to be harmful, if not barbaric. If the methods of evidence-based medicine were applied at that time, the pitfalls of those treatments would have become obvious sooner.

EBM seeks to use the best scientific evidence to improve patient outcomes. Randomized clinical trials and analysis of groups of them, called meta-analysis, are the chief building blocks in EBM.  These tools are not infallible, and may even lead to incorrect results. Nonetheless, EBM is considered an important pivotal advance in the evolution of health care.  Many evidence-based guidelines are accessible online, and there are links on this site as well in the Health Links tab. Sometimes wider application of known therapies  results in more health improvement than new breakthroughs. The popularity of such publications as the American Journal of Medical Quality  and a new member of the American Heart Association family of journals, Circulation: Cardiovascular quality and outcomes, now celebrating its first anniversary, reflects the importance of quality improvement in medicine today.  The purpose: closing the gap between ideal and actual care.  In contrast with some critics, EBM is also practical, if portrayed properly and not betrayed.

Lord Kelvin (Sir William Thomson) said: “Until you can measure something and express it in numbers, you have only the beginning of understanding,” and “If you cannot measure it, you cannot improve it.” He is the chap for whom the Kelvin scale in thermodynamics is named. He knew a lot about measurement and numbers.

Now, about 160 years later, the medical world appears to agree with him.

To vaccinate, or not? Links to help you…

        “As in the blood, so in the man—he is just as weak, just as strong.”                         —Hippocrates

To vaccinate, or not—that is the question of the day. Confusion about Swine flu continues… we might call it a pandemic pandemonium. Consider that while less than 40% of health workers are actually vaccinated, in California nurses were about to go on strike because they received inadquate protection from infected patients, which prompted several new measures in those hospitals. And in the UK, only 17% of Britain’s nurses and doctors regularly get a seasonal flu shot. Dr Mehmet Oz estimates that half of us have doubts about the Swine flu vaccine; his family will not receive them.

A poll conducted online by the British Medical Journal’s email site to physicians, Dr Fiona Godlee, Editor’s Choice, www.bmj.com, reported on  10/28/2009 that 58% responded they would not take the vaccine, and 42% saying they would.

To help you consider the differing views of this national debate, here are some answers:

For Vaccination:

1. Do I Really Need the Swine Flu Vaccine? 

Advice from Medpedia Answers, Infectious Diseases by Edmund M Hayes Pharm D, and Vincent R Racaniello PhD, a microbiologist Professor at Columbia University Medical Center.

      2.   CDC’s Advice to Parents: Swine Flu Shots for All 

Delece Smith-Barrow, Washington Post Staff Writer reviews CDC advice to parents.

      3.   Intense tracking for swine flu shot’s side effects

Yahoo News/Lauran Neergaard, Associated Press Medical Writer tells how the vaccine’s side effects are being tracked.

Against Vaccination:

1. You Tube: A neurological deficit after routine vaccination against  seasonal flu http://www.youtube.com/watch?v=mScGC7nFDxM
2. Real Preventive Medicine & Preventing/Treating Colds & Flu 

Elson Haas MD reviews the role of personal responsibility for lifestyle choices as the basis for true prevention.

      3.  Council on Foreign Relations file: discussion among international politicians and administrators in October, 2009 about overcoming public resistance to Swine flu vaccination, viewable at http://www.youtube.com/watch?v=UKwyeLWNmOM&feature=player_embedded

      4.  Serious Vaccine Reactions to Now Be Called ‘Coincidence’?

Dr Mercola reviews the dismissal of serious side effects from vaccines, and the possible influences of drug company profits upon prevailing recommendations.

     5.  An extensive You Tube discussion by a New York trained internist, now a Benedictine nun in Barcelona, about past experience with H1N1, and the distribution of inactivated human H3N2 flu vaccine contaminated with live H1N5 (Bird Flu) virus by Baxter Labs, also reported by the Times of India.

      6.  Vaccine revolt! Swine flu vaccine support crumbles as flimsy rationale for H1N1 shots becomes apparent 

Mike Adams, the “Health Ranger”, Natural News Editor, sharply challenges the evidence base for near-universal Swine flu vaccination.  

      7.  Swine flu jab link to killer nerve disease: Leaked letter reveals concern of neurologists over 25 deaths in America

Jo MacFarlane, Mail Online (UK) tells how Guillain–Barré syndrome from vaccinations is a constant fear of neurologists , and should not be dismissed (see prior articles in Health News Archives on this site).  

      8.  Be sure to see Part 6 of a series in which the calculations show that the mercury in the common variety of Swine flu vaccine far exceeds allowed content for hazardous waste, about a multiple of 250, and special dangers to the fetus and the very young.

     9.  Observations about H1N1 vaccine production, politics and economics:

Evelyn Pringle’s six part series on the economics and politics: Part 1, Part 2, Part 3, Part 4, Part 5, Part 6

     10. A book now in its 13th edition: The Sanctity of Human Blood: Vaccination I$ Not Immunization  by Tim O’Shea

Preview comments:

Why did children in 1980 only receive 20 vaccines and today’s children are suddenly getting 68?

What are the real facts behind the autism epidemic now sweeping the nation? Do other countries give their children all these shots?

This is one of the only unbiased reference books on the topic, since most of what is available simply recycles the same old story: that vaccines are safe and effective, and that we need more, more and always more. This book is not the  standard alternative medicine point of view; its sources are drawn from mainstream medicine, mainstream science, and mainstream law.
That is where the real opposition to today’s vaccine policy is coming from.

Did you know?

• that there are now some 36 vaccines mandated by the time your child is 18 months old? And 68 by age 18?
• that the 2007 Mandated Schedule contains the Rotateq and Human Papilloma Virus vaccines in multiple doses?
• that U.S. children are the most vaccinated group not only in the world, but in all of history?
• that vaccines are not thoroughly tested before they are put on the market?
• that most infectious diseases had already declined 90% by the time vaccines became mandated?
• that only one country in Europe still has mandatory DPT vaccination, whereas the U.S. requires five separate shots?
• that Hepatitis B vaccine was halted in France after 15,000 citizens filed a class action suit against the government?
• that there is a simple exemption form in most states, which when signed by a parent exempts the child for life?
• that all 696,000 Gulf War personnel were inoculated with three completely untested vaccines, resulting in 80,000 of them contracting a permanent disease known as Gulf War Syndrome? There are many discussions and feeble denials about this syndrome, but many veterans incapacitated…
• that many pediatricians will not inoculate their own children? and Dr Mehmet Oz announced on YouTube that his family would not receive the Swine flu vaccine. Why? Surely they have good reasons.
• that vaccines are a multibillion dollar business in the U.S.?
• that vaccination is not immunization?
• that mercury in vaccines is dozens of times in excess of EPA safety levels?

Can herbs and natural products “boost” immunity?

Yes—under certain circumstances, but the answer is not simple.

Cold and Flu, a Harvard Health Publication, says the various claims that herbs and supplements can “boost” immunity, at least in a way that can benefit patients, are doubtful. Since there are many different kinds of immune cells,  which may target very specific germs, it is difficult to know whether elevations in different immune cells (or their components) brought about by herbs might help any particular infection.

Small molecules called cytokines, released by immune cells, mediate the effects of inflammation and immunity. Cytokines are involved in cell signaling, and their numbers and ratios may be changed significantly by herbs and other natural agents. Herbs with such properties, called “immunomodulators”, can change protein synthesis and gene activity as well. However, while many herbs are known to change numbers or activities of immune cells and cytokines, whether this actually helps in individual infections remains unknown.

The problem of determining whether a given agent helps “immunity” or particular infections is not just limited to herbs or natural substances. Researchers, pharmacologists, and pharmaceutical chemists at drug companies all face similar difficulties.

The immune system is extremely complex and behaves differently according to both the individual and the infectious agent.  Unfortunately, most of the research with herbs is not only difficult to interpret, but has been done in vitro, that is, outside the human body. Since none of these substances are patentable, the necessary animal and human trials to establish effectiveness will probably never be done, since large amounts of money and administrative effort (design and organization of large studies) are lacking.

The effects of echinacea, for instance, have been debated for many years, but a study in patients published in the journal Lancet indicated that it may boost the immune system more than previously believed, decreasing the risk of developing a cold by 58%, as well as shortening the duration of a cold by over a day and a half.  Both positive and negative studies abound. In some negative studies, however, use of  incorrect portions of the plant, inadequate dosing protocols, and products with inferior quality may play a part in the lack of positive findings.

For vitamin D there is an overwhelming medical literature concerning benefits to the immune system, and considerable evidence concerning omega-3 fats and probiotics, although certainly less clear.

While there is in fact substantial and credible evidence that the immune system is altered favorably by many herbs and supplements, and much has been published in peer reviewed journals, randomized clinical trials needed to establish effectiveness and obtain FDA approval are unavailable. Many scientists and investigators believe that if herbs were in the same position as drugs and could be patented, many would be pursued by pharmaceutical houses for FDA clearance—and might very well succeed in several areas.

On a practical basis, it may be irrelevant whether an herb or supplement does or does not help a particular condition. If it is not approved by the FDA for that use in a named disease, it is illegal to claim it does, and it cannot be used for that purpose. If it qualifies under the DSHEA as a food or dietary supplement, it can be made available, but not for prevention, diagnosis, treatment, mitigation of the disease process, or cure in a particular medical illness, but solely for dietary use.

Some months ago, the FDA issued a warning to supplement and natural product manufacturers about claiming their products might be useful in preventing, treating, or modifying Swine or seasonal flu. Many ads disappeared from the internet overnight, but there were about 80 warning letters issued by the FDA within the past six months to vendors.  In the past few days, however, the FDA effort against claims, with the FTC, has picked up again, and Andrew Weil’s site, www.drweil.com, received  such a letter. Dr. Weil, a well known physician, educator, and author, is a recognized authority on integrative medicine. The agencies said the site stated “Dr. Weil’s Immune Support Formula can help maintain a strong defense against the flu” and claimed it has “demonstrated both antiviral and immune-boosting effects in scientific investigation.” Astragalus is the particular herb Dr Weil discussed, the subject of a Wall Street Journal review on May 26, 2009 which also confirmed a “boosting” effect. Astragalus has no lack of supporters for this purpose.

Shortly thereafter in October, the FDA posted a compliation of 140 drugs, devices and equipment sold on the Internet they deemed fraudulent swine-flu-fighting products. These did not include, of course, all herbs and substances with immune effects identified in the laboratory, only those products that made such claims.

Under the Federal Food, Drug, and Cosmetic Act (FFDC Act) 21 U.S.C. §§ 331, 351, 352, no substance, technique, or device may claim to diagnose, mitigate, prevent, treat, or cure a disease unless approved by the FDA, and this product had no approval. The approved agents for influenza are Tamiflu® (oseltamivir), inhaled Relenza® (zanamivir), and vaccines. BioCryst Pharmaceutical Inc.’s antiviral drug peramivir for intravenous use has recently been approved for patients with H1N1 who “may not benefit from conventional treatments or where an infusion is likely to be more beneficial.”

What is generally acknowledged: following a healthy prudent lifestyle with good nutrition (including a plant-based diet high in omega-3 fats, low in saturated fat) adequate exercise, keeping one’s weight down, stress management, sufficient restful sleep, moderate use of alcohol, avoiding toxins (including smoking, pollution, and street drugs), and a multivitamin daily is good for the immune system. In addition having sex one or two times per week may raise levels of a particular antibody class, IgA, by as much as 30%.

Whether you believe certain nutrients help, well, that is an individual matter…