IOM's new vitamin D recommendations flawed

We consider the new vitamin D recommendations made by the Institute of Medicine (IOM) woefully inadequate and detrimental to public health. It is very simple to discount much of this report because the IOM is basing their new recommendations assuming minimal sun exposure and on individuals who DO NOT have the following special concerns:

• Adiposity (overweight or obese)
  
• Persons living at the upper latitudes in North America
• Persons who experience reduced vitamin D synthesis from sun exposure
  Dark skin
  Use of sun screen
  Indoor environments and institutionalized older persons
• Alternative diets or changes in dietary patterns
  Dairy and animal product exclusion
• Use of calcium supplements
• Oral Contraceptive use
• Premature infants
• Interaction between vitamin D and prescription drugs
  

What would be the percentage of the population who get minimal sun exposure (without sunscreen) and DO NOT have one or more of the aforementioned? It would be very small. Much of the country is overweight or obese. Much of the population receives inadequate sun exposure, spends much of their time indoors, and uses sunscreen when they are in the sun. We cannot understand why the IOM would not come up with more individualized recommendations to include all of the aforementioned groups.

At least they leave wiggle room between the RDAs and upper tolerated levels (which we still think are too low). If you are a client of ours, stick with your individualized recommendations.

We are not alone in discounting the IOM's recommendations. We have already heard from clients that their own doctors are telling them to ignore the recommendations. Here is a smattering of quotes from doctors and other health professionals across the country:

• Robert Rountree, MD, a medical author and practicing physician in Boulder, Colorado. “This report does not represent the views of researchers who are true experts in the field,” Rountree said. “For reasons that I don't understand, the panel members deliberately chose to ignore a large body of published information regarding the effects of vitamin D in cancer, cardiometabolic disease, obesity, autoimmune disease and mood regulation and instead focused almost exclusively on studies related to bone health. They also failed to make the case that vitamin D supplements are toxic in the dose ranges currently being recommended (2000 IU to 10,000 IU daily). There is nothing in the IOM report that makes me want to change my current recommendation to aggressively monitor vitamin D levels with frequent blood testing in my patients and to supplement as necessary to maintain adequate levels.”
  

• John Jacob Cannell, MD, takes issue with the new vitamin D guidelines. “After 13 years of silence, the quasi governmental agency, [the IOM’s FNB] recommended that a three-pound premature infant take virtually the same amount of vitamin D as a 300 pound pregnant woman,” Cannell writes. “While that 400 IU/day dose is close to adequate for infants, 600 IU/day in pregnant women will do nothing to help the three childhood epidemics most closely associated with gestational and early childhood vitamin D deficiencies: asthma, auto-immune disorders, and, as recently reported in the largest pediatric journal in the world, autism.”
  

• "There's no way that people will satisfy those recommendations for vitamin D without supplements," says Elizabeth Ward, a registered dietitian in Boston in a USA Today interview.
  
  
• "This is a stunning disappointment," said Dr. Cedric Garland, one of the top researchers who has studied the ability of vitamin D to prevent cancer.
  

Since the IOM announcement Tuesday, these vitamin D studies have been published:

• A study from American Journal of Clinical Nutrition investigated the associations between vitamin D status and changes in body mass index, skinfold-thickness ratio, waist circumference, and height in child subjects living in warm weather climates. Vitamin D–deficient children had a greater change in BMI than did vitamin D–sufficient children. Similarly, vitamin D–deficient children had a greater change in subscapular-to-triceps skinfold-thickness ratio and a greater change in waist circumference than did vitamin D–sufficient children. Vitamin D deficiency was related to slower linear growth in girls but not in boys. Vitamin D status was inversely associated with the development of adiposity in school-age children.
  
  
• A Journal Nutrition study confirms that serum 25(OH)D concentrations undergo strong seasonal variation at high latitudes and are influenced by vitamin D intake, skin pigmentation, and sun exposure.
  
  
• Emerging evidence suggests a high prevalence of suboptimal vitamin D (as defined by serum 25(OH)D levels of less than 32 as well as an association between lower serum levels and higher mortality in cancer. Researchers in Nutrition Journal investigated the effect of oral vitamin D supplementation as a means for restoring suboptimal levels to optimal levels in 2198 cancer patients. Patients with baseline levels less than 32 were considered to have suboptimal serum 25(OH)D levels and were supplemented with 8000 IU of Vitamin D3 (four 2000 IU D3 capsules) daily as part of their nutritional care plan.
  
  The response to supplementation from suboptimal to optimal levels was greatest in patients with prostate and lung cancer as well as those with baseline levels between 20-32. Because of this, the impact of improved serum 25(OH)D levels on patient survival and quality of life needs to be further investigated.

IOM's New Vitamin D Recommendations By Life Stage:
Adequate Intake (AI)
Tolerable Upper Level Intake (UL)
Recommended Daily Allowance (RDA)

Infants 0-12 months
400IU - AI
1000IU-1500IU - UL

Children 1-3 years old
600IU - RDA
2500IU - UL

Children 4-8 years old
600IU - RDA
3000IU - UL

Females (including pregnant or lactating) and Males 9-70
600IU - RDA
4000IU - UL

Females and Males 70 and above
800IU - RDA
4000IU - UL

Once Again: magnesium and risk of sudden cardiac death in women

Researchers examined the association between magnesium, as measured in diet and plasma, and risk of Sudden Cardiac Death Syndrome. The analysis, which appeared in the American Journal of Clinical Nutrition, was conducted within the Nurses' Health Study. The association for magnesium intake was examined prospectively in 88,375 women who were free of disease in 1980. 505 cases of sudden or arrhythmic death were documented over 26 y of follow-up. The relative risk of SCD was significantly lower in women in the highest quartile compared with those in the lowest quartile of dietary and plasma magnesium. In conclusion, higher plasma concentrations and dietary magnesium intakes were associated with lower risks of SCD in women. If the observed association is causal, interventions directed at increasing dietary or plasma magnesium might lower the risk of SCD.

This adds more evidence to the even stronger October study in American Heart Journal

Bifidus crucial for a baby's digestion

Infants may more efficient at digesting and utilizing nutritional components of milk than adults due to a difference in the strains of bacteria that dominate their digestive tracts. Researchers report on genomic analysis of these strains in the November 2010 issue of the journal Applied and Environmental Microbiology identifying the genes that are most likely responsible for this difference.

"Human milk oligosaccharides (HMOs) are the third-largest solid component of milk. Their structural complexity renders them non-digestible to the host," say the researchers. "Bifidobacterium longum strains often predominate the colonic microbiota of exlusively breast-fed infants. Among the three recognized subspecies, B. longum subsp. infantis achieves high levels of cell growth on HMOs and is associated with early colonization of the infant gut."

The results of this study suggest that B. longum has at least 2 distinct subspecies: B. longum subsp. infantis, adapted to ultilize milk carbon and found primarily in the digestive tract of children, and B. longum subsp. longum, specialized for plant-derived carbon metabolism and associated with the adult digestive tract. "Although early gut colonization is likely dependent on a multitude of dietary and nondietary factors, the delivery of complex oligosaccharides through milk creates an ideal and unique nutrient niche for the establishment of, and colonization by, B. longum subsp. infantis strains," say the researchers. "During weaning, a gradual transitioning from milk-based to plant-based diets generates a shift in carbon availability in the gastrintestinal tract favorable for the expansion and formtion of an adult-like gastointestinal tract microbiota."

Bonnie - this is why it is paramount for formula-fed infants especially to supplement with bifidus and acidophilus as the study below alludes to.

Lactobacillus rhamnosus strain GG (LGG) reduces the frequency and severity of abdominal pain in children with irritable bowel syndrome (IBS), with persistent benefit once treatment is stopped, according to the results of a randomized, double-blind, placebo-controlled trial reported in Pediatrics.

The main study endpoint was overall pain at the end of the intervention period. Frequency and severity of abdominal pain were reduced from baseline with LGG but not with placebo. More than half (59%) of participants had abnormal intestinal permeability test results at study entry. This percentage decreased significantly in the LGG group but not in the placebo group.

Cough meds off the market, kids ER visits drop 50%

The number of babies and toddlers who go to the emergency room because of cough and cold medicines fell by more than 50% after manufacturers stopped selling products labeled for children under 2 in October 2007, says the Centers for Disease Control and Prevention. Because kids' respiratory systems are still developing, the meds can cause abnormal heart rhythms and seizures, or cause kids to stop breathing. To address safety concerns in older children, the Consumer Healthcare Products Association updated cough and cold medicine labels in October 2008, warning not to give them to children under 4.

Steve - this is very good news and the FDA should be applauded for taking these measures.

Low Fat Finally Gets the Boot.

Bonnie and Steve:
In one of the biggest missteps of the last forty years, public health educators convinced most Americans that eating low-fat foods was good for their health. After seeing our population become fatter than any time in its history, FINALLY, researchers are putting that catastrophic notion to bed.

The chief proponent of this dietary faux pas, American Dietetic Association (ADA), finally swallowed their pride and admitted at their annual conference there is strong evidence that replacing fat with carbohydrates could be harmful to health. Recommendations to reduce saturated fat intake are largely based on the notion that high levels increase risk of cardiovascular disease, but unless saturated fat is replaced with other fats, many studies have suggested that fat reduction could increase risk of heart disease.

At the conference, four leading experts presented evidence suggesting that low fat diets may be less healthy than those containing at least a moderate amount of fat. In particular, all four agreed that replacing saturated fat with carbohydrates – as has been widely recommended in the United States – is likely to raise the risk of cardiovascular disease. "The emphasis should be on displacing saturated fat and trans fat with unsaturated fat because that is where the data is,” one researcher said. “…‘Displace saturated fat with polyunsaturated fat’ was simplified to ‘low fat’. Then ‘low fat’ became ‘low calorie’. The low fat message is still very pervasive, especially in the lay press.”

Chair of the Harvard School of Public Health’s nutrition department Dr. Walter Willett took it even further. “If anything, the literature shows a slight advantage of the high fat diet,” he said. “The focus on fat in dietary guidelines has been a massive distraction…We should remove total fat from nutrition facts panels on the back of packs.” He added that while the pervasive dietary guidance given to consumers has been to eat fats sparingly, to load up on starch and eat non-fat products, “the food industry quickly realized sugar was cheaper than fat and laughed all the way to the bank.” “It was really the type of fat that was important,” he said. “If you replaced saturated fat with polyunsaturated fat there was a reduction of risk.”

“The biggest problem in America at the moment is eating behavior,” Professor of public health and professor of epidemiology at the University of Pittsburgh’s Graduate School of Public Health, Dr. Lewis Kuller said. “…Eating is a social pleasure and not a therapeutic challenge. We have done a great job of confusing the public.”

Assistant professor of medicine at Harvard Medical School Dr. Mozaffarian agreed with the other speakers about a lack of evidence linking total fat consumption and cardiovascular disease risk. High levels of low density lipoprotein (LDL cholesterol) and high triglyceride levels have both been linked to increased risk of cardiovascular disease, but Mozaffarian said there has often been overreliance on single biomarkers in drawing conclusions about fats’ impact on heart health, “even one as hallowed as LDL cholesterol”. “Overall dietary quality is very important for cardiovascular risk,” he said. “Saturated fats may raise LDL cholesterol but increasing levels of all fats lowers triglycerides…You can’t look at data across countries and draw conclusions. Nor can you look at animal studies or a single biomarker and draw conclusions from that.”

Concluding the discussion, Dr. Lichtenstein warned against focusing on single nutrients for disease risk reduction. She said: “We need to stop focusing on individual dietary components because when one goes down, another goes up.”

Don't these comments sound awfully similar to what somebody you know has been saying for a long, long time now? This next piece adds even more fascinating fuel to the fire.

Reducing Carbs the key to Quality Longevity?

Excerpts from a recent article in The Daily Mail

The problem is that this longevity does not mean a healthier life, thanks to chronic diseases such as diabetes and arthritis. But now a U.S. geneticist is thought to have discovered a secret to a long life, full of health and energy. And the answer might be as simple as cutting down on carbohydrates.

University of California, San Francisco Professor Cynthia Kenyon, whom many experts believe should win the Nobel Prize for her research into aging, has discovered that the carbohydrates we eat directly affect two key genes that govern youthfulness and longevity. She made her remarkable breakthrough after studying roundworms. By tweaking some of their genes she has been able to help these worms live up to six times longer than normal, as well as make them stay healthy all that time as well.

Professor Kenyon’s work has been successfully repeated in labs around the world — the genes she found controlling aging in worms do the same thing in rats and mice, probably monkeys, and there are signs they are active in humans, too. This work has revolutionized our understanding of aging. Ten years ago, scientists thought aging was probably the result of a slow decay, a sort of rusting. But Professor Kenyon has shown that it’s not about wear and tear, but instead it is controlled by genes.

At 18 days old the average roundworm is flabby, ­sluggish and wrinkled. Two days later it will probably be dead.
Professor Kenyon found that damping down the activity of just one of their genes had a dramatic effect. Instead of dying at about 20 days, the first set of mutant worms carried on living to more than 40 days. They weren’t sluggish and worn out — they behaved like youngsters. In human terms it was the equivalent of talking to someone you thought was about 30 and finding they were actually 60. With more sophisticated genetic manipulation, she now has some worms that have lived for an astonishing 144 days. An increase of that proportion would allow humans to live to 450.

Professor Kenyon found out was why ­drastically reducing calories has such a remarkable effect. She discovered that it changed the way two crucial genes behaved. It turned down the gene that controls insulin, which in turn switched on another gene, which acted like an elixir of life. We jokingly called the first gene the Grim Reaper because when it’s switched on, the lifespan is fairly short. The ­second ‘elixir’ gene seems to bring all the anti-aging benefits — its proper name is DAF 16, but it was quickly nicknamed ‘Sweet Sixteen’ because it turned the worms into teenagers. It sends out instructions to a whole range of repair and renovation genes. Your supply of natural anti­oxidants goes up, damping down damaging free radicals. The Sweet Sixteen gene also boosts compounds that make sure the skin and muscle-building ­proteins are working properly, the immune system becomes more active to fight infection and genes that are active in cancer get turned off.

Discovering the Grim Reaper gene has prompted the professor to ­dramatically alter her own diet, ­cutting right back on carbohydrates. That’s because carbs make your body produce more insulin (to mop up the extra blood sugar carbs ­produce); and more insulin means a more active Grim Reaper. So the vital second gene, the ‘elixir’ one, won’t get turned on.

To test this, last year she added a tiny amount of ­sugary glucose to the normal diet of some of her worms that had had their genes engineered so they were living much longer, healthier lives. The effect was remarkable. The sugary glucose blocked the “youthful” genes and they lost most of the health gains.

Following Kenyon’s lead, other researchers started looking for the Grim Reaper/ Sweet Sixteen combination in other animals — and of course in humans. They found it. One clue came from a small remote community of dwarves living in northern Ecuador who are cancer-free. They are missing the part of the Grim Reaper gene that controls a hormone called insulin-like growth factor. The downside is they only grow to 4ft tall because the hormone is needed for growth.
But this missing bit of the Grim Reaper gene also means they don’t develop cancer and are less likely to suffer from heart disease or obesity.

Research is at its early stage, but raised insulin triggers an increase in cholesterol production in the liver, makes the walls of blood vessels ­contract so blood pressure goes up and stimulates the release of fats called triglycerides.

Besides dietary modification, Kenyon says, another way to reduce insulin levels is to exercise, which makes you more sensitive to it, which in turn means you need less of it. It also gives another health benefit in a surprising way. Exercise actually increases the level of damaging free radicals which stimulates the body to produce more protective anti-oxidants.

Results of the Largest Study on Diet Ever Done
Researchers at the Faculty of Life Sciences (LIFE), University of Copenhagen, can now unveil the results of the world's largest diet study: If you want to lose weight, you should maintain a diet that is high in proteins with more lean meat, beans and fewer finely refined starch calories such as white bread and white rice. With this diet, most people can also eat until they are full without counting calories and without gaining weight. Finally, the extensive study concludes that the official dietary recommendations are not sufficient for preventing obesity.

The design comprised the following five diet types:
-A low-protein diet (13% of energy consumed) with a high glycemic index (GI)
-A low-protein, low-GI dietA high-protein (25% of energy consumed), low-GI diet
-A high-protein, high-GI diet
-A control group which followed the current dietary recommendations without special instructions regarding glycemic index levels
-A high-protein, low-GI diet works best A total of 938 overweight adults with a mean body mass index (BMI) of 34 kg/sq m were initially placed on an 800-kcal-per-day diet for eight weeks before the actual diet intervention was initiated.

The average weight regain among all participants was 0.5 kg, but among the participants who completed the study, those in the low-protein/high-GI group showed the poorest results with a significant weight gain of 1.67 kg. The weight regain was 0.93 kg less for participants on a high-protein diet than for those on a low-protein diet and 0.95 kg less in the groups on a low-GI diet compared to those on a high-GI diet.

The study was conducted by eight European research centers and headed by Thomas Meinert Larsen, PhD, and Professor Arne Astrup, DrMedSc and Head of Department at the Faculty of Life Sciences (LIFE) and is funded by an EU grant of EUR 14.5 million.

Gratitude Good for Health

Melinda Beck of the Wall Street Journal wrote a fascinating piece about research that suggests maintaining an attitude of gratitude can improve psychological, emotional and physical well-being. You can also take a "How Grateful Are You" Test.

Thank You. No, Thank You.

Iron deficiency in babies

Iron deficiency in babies and toddlers is getting increased attention. Up to 15% of babies and toddlers don't get enough iron. This can lead to long-term developmental problems, even in babies who aren't deficient enough to become anemic. New guidelines from the American Academy of Pediatrics recommend supplements for some babies, especially breastfed babies aged 4-6 months and preterm babies. When a supplement is needed, consider using a plain iron drop or a combination product for breastfed babies to provide both iron and vitamin D. Keep in mind that iron concentration can vary from product to product. Please work with your doctor or licensed health professional to make the right choice.

Healthy Lifestyle or Genetics?

Two large studies confirm a healthy lifestyle has the biggest impact on cardiovascular health. One study shows the majority of people who adopted healthy lifestyle behaviors in young adulthood maintained a low cardiovascular risk profile in middle age. The other study shows cardiovascular health is due primarily to lifestyle factors and healthy behavior, not heredity. The studies will be presented at the American Heart Association Scientific Sessions 2010.

"Health behaviors can trump a lot of your genetics," said Donald Lloyd-Jones, M.D., chair and professor of preventive medicine at Northwestern University Feinberg School of Medicine and a staff cardiologist at Northwestern Memorial Hospital. "This research shows people have control over their heart health. The earlier they start making healthy choices, the more likely they are to maintain a low-risk profile for heart disease."

The first Northwestern Medicine study investigated why most young adults, who have a low-risk profile for heart disease, often tip into the high-risk category by middle age with high blood pressure, high cholesterol and excess weight. The unhealthy shift is the result of lifestyle, the study found. More than half of the young adults who followed five healthy lifestyle factors for 20 years were able to maintain their low-risk profile for heart disease though middle age.

Researchers tracked participants' diet, physical activity, alcohol consumption, smoking, weight, blood pressure and glucose levels at the baseline year, year seven and year 20. After 20 years, the prevalence of a low-risk profile was 60 percent for participants who followed all five healthy lifestyle factors, 37 percent for four factors, 30 percent for three factors, 17 percent for two and 6 percent for one or zero. The results were similar for men only, women only, black only and white only.

The second Northwestern Medicine study examined three generations of families from the Framingham Heart Study to determine the heritability of cardiovascular health. Heritability includes a combination of genetic factors and the effects of a shared environment such as the types of foods that are served in a family. Only a small percentage of the United States population -- 8 percent -- has ideal levels of all the risk factors for cardiovascular health at middle age. The study found that only a small proportion of cardiovascular health is passed from parent to child; instead, it appears that the majority of cardiovascular health is due to lifestyle and healthy behaviors. "What you do and how you live is going to have a larger impact on whether you are in ideal cardiovascular health than your genes or how you were raised," said Norrina Allen, the lead study author and a postdoctoral fellow in preventive medicine at the Feinberg School. The Northwestern Medicine study looked at three generations of families including 7,535 people at age 40 and a separate group of 8,920 people at age 50. The goal was to see who was in ideal cardiovascular health at these two critical periods in middle age.

Piggybacking on the aforementioned studies, regular exercise can reduce around two dozen physical and mental health conditions and slow down how quickly the body ages. Health conditions covered by the review include: cancer, heart disease, dementia, stroke, type 2 diabetes, depression, obesity and high blood pressure.

Published in the December issue of IJCP, the International Journal of Clinical Practice, the study says that apart from not smoking, being physically active is the most powerful lifestyle choice any individual can make to improve their health. Health benefits identified by the review include:

• Regular moderate to intense physical activity is associated with decreased risk of coronary heart disease and ischaemic and haemorrhagic stroke.
• A growing body of evidence suggests that increasing physical activity can also reduce the risk of certain types of cancers, osteoporosis, type 2 diabetes, depression, obesity and high blood pressure.
• Evidence of the beneficial effects of physical activity in the primary prevention and management of cancer is growing and there is an association between higher levels of physical activity and lower cancer death rates.
• Research has found that walking or cycling for at least an half-an-hour a day is associated with a reduction in cancer and that when this is increased to an hour cancer incidence falls by 16 per cent.
• Evidence is mixed when it comes to specific cancers. Research has shown a strong relationship between increased physical activity and reduced colon cancer in both sexes. And men who are more active at work -- not just sitting at a desk -- have lower rates of prostate cancer.
• Other cancer studies show that physical activity after diagnosis can aid recovery and improve outcomes.
• Studies have also shown that men who are physically active are less likely to experience erection problems.
• There is growing evidence that physical activity could decrease the risk of dementia in the elderly.
  

Recommendations identified by the review include:

• Healthy adults aged between 18 and 65 should aim for 150 minutes of moderate intensity physical activity a week, such as 30 minutes of brisk walking, five days a week. And people who undertake more vigorous intensity exercise, such as jogging, should aim for 20 minutes three days a week.
• Healthy adults should aim for two strength-training sessions a week that work with the body's major muscle groups.
• Older people can benefit from exercise that helps to maintain their balance and flexibility.
• People who are physically active should continue to exercise even when they become middle aged or elderly and those who aren't should increase their physical activity.Not smoking and following a healthy diet is also important.
  
• Ideally, to gain maximum health benefits people should exercise, not smoke, eat a healthy diet and have a body mass index of less than 25.
  

Merck keeping secret from statin users.

Secret Revealed
Merck has had a patent on a statin/coQ10 combination since the late 1980's. The following claim from one of two 1990 Merck patents (4,933,165) states that adding add CoQ10 to statin drugs overcomes statin induced myopathy: "A pharmaceutical composition comprising a pharmaceutical carrier and an effective antihypercholesterolemic amount of an HMG-CoA reductase inhibitor and an amount of Coenzyme Q.sub.10 effective to counteract HMG-CoA reductase inhibitor-associated skeletal muscle myopathy."

Unfortunately, the combination was never introduced into the marketplace. This should have been a no-brainer given that research shows patients on the combination live an average of 8 years longer versus only 5 for statins alone. This should not come as a surprise given the fact that statins deplete the body of coQ10, rendering the performance of the mitochondria in our cells less effective. Excuse the sarcasm, but three more years of selling statins - what's not to like for Merck?

All About Cost
In our opinion, Merck knew the world supply of CoQ10 was limited, was costly to produce, and predicted that production would only supply one-sixth of the world's statin users. In 1990, when Merck sought and received the patent for Mevacor and other statin drugs formulated with up to 1,000 mg of coenzyme Q10 to prevent or alleviate cardiomyopathy, a serious condition that can cause congestive heart failure, they realized the cost of the drug would be too exorbitant to make it a worldwide blockbuster.

Why Not Make Amends Now?
Lawyers note that to launch such a product would be a tacit acknowledgment that statins alone do indeed cause earlier deaths, and the class-action suits would fly.

The Ramifications
As a result of their tremendously reckless decision, Merck made the issue worse by not educating physicians about the important of supplementing CoQ10 to offset the dangers of these drugs. And because they hold the patent, other drug companies are prevented from coming out with a statin/CoQ10 product. To add insult to injury, a new study says that the global campaign to use statins as a preventive therapy in healthy individuals is misguided.

New Data Says Preventive Statin Therapy Campaign Misguided
Rolling back suggestions from previous studies, a Johns Hopkins study of 950 healthy men and women has shown that taking daily doses of a cholesterol-lowering statin medication to protect coronary arteries and ward off heart attack or stroke may not be needed. The Johns Hopkins team found that nearly 95 percent of all heart attacks, strokes or heart-related deaths occurred in the half of study participants with some measurable buildup of artery-hardening calcium in the blood vessels; hence, only this subgroup might have benefited from preventive drug therapy.

Seventy-five percent of all heart emergencies occurred in the quarter with the highest calcium scores. The 47 percent of study participants with no detectable levels of calcium buildup in their blood vessels suffered about 5 percent of heart-disease related events during the six-year study, meaning that drug therapy may not have offered any coronary protection. "Statin therapy should not be approached like diet and exercise as a broadly based solution for preventing coronary heart disease. These are lifelong medications with potential, although rare side effects, and physicians should only consider their use for those patients at greatest risk, especially those with high coronary calcium scores," says researchers. "As many as 5 percent of people on statins develop serious side effects, such as muscle pain. One in 255 will develop diabetes."

Results of the study do underscore the importance of measuring coronary artery calcium deposits in predicting who is really at risk of suffering a heart attack. And the long-term ramifications of a CoQ10-depleted world population from high statin drug is unknown.

Your thoughts?

Slim Down Your Favorite Recipes

• Substitutes for high fat milk or cream:
  Use lowfat milk or milk substitute (preferably with no added sugar); if a recipe calls for one cup ½ & ½ use ¼ - 1/3 cup with the rest water.
  

• Substitutes for high fat cheese:
  Blue cheese> Feta
  High fat mozzarella> low fat mozzarella
  Other cheeses> use half the amount called for in the recipe and flavor the rest with Parmesan, Romano, Asiago, and/or Manchego cheese
  

• Substitute for sour cream:
  Use the same amount of lowfat or no fat Greek yogurt (this will also give you an extra boost of protein and calcium.
  

• Make soups and stews the day before and refrigerate so that you can easily remove the hardened fat (or made on the same day, use the fat skimmer).
  
  
• To make delicious “skinny” gravy:
  Remove all fat (with a fat skimmer) from the pan drippings. Add homemade or low sodium organic broth, and optional wine, for enhanced flavor.
  

• To reduce saturated fat and salt:
  Trim all fat before cooking meat and poultry. Boost flavor with aromatic herbs, pureed vegetables, low sodium organic vegetable/chicken broth/V-8, and lots of onion, garlic, and/or shallots to add flavor while removing excess fat and sodium. If you add a little salt directly before serving, the salt flavor will be stronger. Reheating with microwaving will also enhance a salty taste.
  

• To reduce sugar for homemade baked goods:
  Cut the amount of sugar called for in half. Enhance a “sweet flavor” with spices such as vanilla, nutmeg, cinnamon, ginger, and allspice. Also, using strong flavored sugars such as pure maple syrup, agave, honey and molasses enhance the taste of “sweet” while using lower amounts.
  

• To reduce saturated and trans fats for homemade baked goods:
  If a recipe calls for more than one egg, use one whole egg with the rest egg whites (2 egg whites= one whole egg). Cut the amount of butter in half. Substitute the rest with fruit purees (such as applesauce) and/or a healthy oil such as canola, avocado, or safflower. Make sure to add extra flour if switching from a solid to a liquid. If a recipe calls for lard or margarine, substitute with one of the healthy, no trans fat spreads (our favorite is Earth Balance). Add nuts or nut butters to recipes to enhance the “mouth feel” and flavor of fat (it also keeps you more satisfied with a smaller portion).
  

Copyright 2010, Nutritional Concepts

Best antibiotic treatment for ear infection? No antibiotic treatment at all.

Using antibiotics to treat newly diagnosed acute ear infections among children is modestly more effective than no treatment, but comes with a risk of side effects. Researchers found no evidence that name-brand antibiotics work any better in general than generic antibiotics and that careful examination of the eardrum by a clinician for signs of infection is critical for accurate diagnosis of acute ear infections. The study is published in the Journal of the American Medical Association. "Our findings reinforce the existing knowledge that the best antibiotic treatment for common childhood ear infections may be no antibiotic treatment at all," said the lead author. "Prescribing antibiotics early may help cure ear infections a little bit faster, but also raises the risk that children will suffer antibiotic-related side effects such as a rash or diarrhea."

Of 100 average-risk children with acute ear infections, about 80 would be expected to get better within about three days without antibiotics. If all were treated with antibiotics immediately at diagnosis, evidence suggests an additional 12 would improve, but three to 10 children would develop a rash and five to 10 would develop diarrhea.

Bonnie - because of the devastating effects antibiotic's have on healthy gut flora, reoccurring infections and other gut related issues are likely.

CFS may be linked to bowel

by Dr. Patrick Massey
Contributor to The Daily Herald

Chronic fatigue syndrome can be a devastating medical condition. Theories abound as to the cause, including chronic viral and bacterial infections, weakened immune system, endocrine abnormalities and even psychosocial connections (it’s all in your head). The exact number of Americans affected by CFS is unknown, but there are estimates of between three and 3,000 cases of CFS per 100,000 people in the U.S., which translates to 3,000 to 3 million people affected.

Although the exact cause has not been determined, there is ample evidence that CFS may be related to another chronic medical condition involving the bowel, leaky gut syndrome. CFS usually starts after flu-like illness or a period of chronic stress. It is generally defined as having at least four of the following symptoms: profound exhaustion after exercise, impaired memory/concentration, unrefreshing sleep, muscle/joint pain, headaches, tender lymph nodes and recurring sore throat without obvious infection. CFS patients often have symptoms of irritable bowel (in my experience 100 percent), new onset food allergies and chemical sensitivities, and low blood pressure with dizziness when standing up too quickly. No medications seem to be effective and the success of many nontraditional medicine therapies is limited. CFS shares many symptoms with chronic infections, but a causal association with viral infections and Lyme disease is inconsistent. However, the symptoms of CFS do closely mimic the common symptoms of leaky gut syndrome.

Leaky gut syndrome is a condition where the bowel literally becomes “leaky” and toxins can be introduced into the blood stream in high concentrations. These toxins often come from bacteria and yeast and can affect many organ systems. LGS is related to chronic poor food selection, medications especially antibiotics and stress. It is related to a condition called bacterial dysbiosis, where “bad” bacteria colonize the bowel and, in some cases, can result in life-threatening illnesses. Symptoms of LGS include fatigue, muscle and joint pain, insomnia, headaches, changes in memory and irritable bowel symptoms. In a recent medical publication (BMC Medicine, 2010), the correlation between CFS and chronic inflammation associated with LGS was examined. This paper explored the research on CFS and concluded that a chronic inflammatory state may be one of the foundation stones of CFS. They also suggested that a “leaky” gut would be a likely source for the regular introduction of pro-inflammatory and toxic compounds into the body. These compounds can damage DNA and inhibit energy production resulting in fatigue, muscle weakness and pain, and changes in memory and cognition. Many of these pro-inflammatory and toxic compounds may be related to many of the symptoms of both CFS and LGS. Therefore, a reasonable argument can be made that the root cause of CFS may originate in the bowels.

Although there are no specific tests for CFS, LGS can be measured by a simple urine test. Treatment for LGS focuses on select supplements, food choices and other simple lifestyle changes. In my personal experience, many people with CFS can get significantly better with lifestyle changes including improving bowel function.

• Patrick B. Massey, M.D., Ph.D is medical director for complementary and alternative medicine for the Alexian Brothers Hospital Network.

1 in 7 harmed during hospitalization

Courtesy of Wall Street Journal

Medicare's new chief called for more steps to improve patient safety, in the wake of a government report that said one in seven hospitalized Medicare patients is harmed during their stay. About 1.5 percent of those patients, or 15,000 people a month, suffered a complication that contributed to their death, the inspector general for the Department of Health and Human Services said.

"We have to do better," Dr. Donald Berwick, a well-known quality-care specialist, told reporters. His agency unveiled a new Medicare "innovation center" designed to develop and test ways to improve quality of care and lower health care costs for everyone, not just Medicare recipients. The program is one of several established by the new health care law to help Medicare spur improvements in patient safety. Initial projects focus on helping primary care physicians better coordinate care across multiple health providers, countering today's fragmented care that too often leaves one doctor not knowing what tests or treatments someone received or missed elsewhere.

The Institute of Medicine a decade ago warned that up to 98,000 people a year die from medical mistakes alone. The new HHS report analyzed the records of 780 Medicare patients hospitalized in October 2008 to examine mistakes and unavoidable consequences of treatment, such as previously unknown drug allergies or medication side effects. During that month, 134,000 Medicare patients suffered at least one adverse event while hospitalized, 44 percent of which were preventable, the report concluded.

Steve - suffice it to say, for what Americans pay for health care, this is inexcusable.

Alcoholic energy drinks to be banned

Alcoholic energy drinks will be effectively banned by U.S. regulators after reports of deaths and hospitalizations in young people, according to Senator Charles Schumer. The Food and Drug Administration plans to announce that caffeine isn’t a safe addition to alcoholic beverages, ending a yearlong review of the products. The Federal Trade Commission will tell manufacturers that marketing these products is potentially illegal. Washington, Michigan, Utah and Oklahoma and some colleges banned the drinks after reports of young people being sick or injured after consuming them.

Bonnie - the official ruling from the FDA about this issue cannot come soon enough as far as I am concerned.

Childhood weight affected by vitamin D deficiency

Kids who are deficient in vitamin D accumulated fat around the waist and gained weight more rapidly than kids who got enough vitamin D, a new study that appears in American Journal of Clinical Nutrition suggests. The investigators recruited a group of 479 school children ages 5-12 from Bogota, Colombia, in 2006 and followed them for about 30 months. They measured vitamin D in blood taken at the beginning of the study, and then examined the link between vitamin D levels and changes in three indicators of body fat over time: body mass index, waist circumference and subscapular-to-triceps skin fold ratio.

Researchers found that the kids with the lowest vitamin D levels at the beginning tended to gain weight faster than the kids with higher levels, who added that children with the lowest vitamin D levels had more drastic increases in central body fat measures. Vitamin D deficiency was also linked to slower growth in height among girls but not boys.

Of all the children tested, 10 percent were vitamin D deficient, and another 46 percent of kids were insufficient, which meant they were at risk of becoming deficient. Bogota, Colombia is in a subtropical zone where one may not expect to find a lot of vitamin D deficiency since the assumption is that sunlight is abundant there.

Lovaza no help for atrial fibrillation

Atrial fibrillation (AF) is common, yet there remains an unmet medical need for additional treatment options. Current pharmacological treatments have limited efficacy and significant adverse events.

To evaluate the safety and efficacy of prescription omega-3 fatty acids (prescription omega-3) for the prevention of recurrent symptomatic AF, a prospective, randomized, double-blind, placebo-controlled, parallel-group multicenter trial involving 663 US outpatient participants with confirmed symptomatic paroxysmal (n = 542) or persistent (n = 121) AF, with no substantial structural heart disease, and in normal sinus rhythm at baseline was performed.

Lovaza (a prescription omega-3) at 8 grams/day or placebo were given for the first 7 days; prescription omega-3 (4 g/d) or placebo thereafter through week 24. At 24 weeks, in the paroxysmal AF stratum, 129 of 269 participants (48%) in the placebo group and 135 of 258 participants (52%) in the prescription group had a recurrent symptomatic AF or flutter event. In the persistent AF stratum, 18 participants (33%) in the placebo group and 32 (50%) in the prescription group had documented symptomatic AF or flutter events. There was no difference between treatment groups for recurrence of symptomatic AF in the paroxysmal stratum. JAMA 11/12/2010

Among participants with paroxysmal AF, 24-week treatment with prescription omega-3 compared with placebo did not reduce recurrent AF over 6 months.

Bonnie - maybe they should have used another omega-3 supplement for this study. I have never been a supporter of Lovaza because it contains trans-fat, to which experts have agreed that there is no safe level. What's worse is that as recently as last year, partially hydrogenated vegetable oil was posted on Lovaza's label (go to page 12). Now, it is not listed (see page 7). We contacted GlaxoSmithKline, the manufacturer of Lovaza and pharmaceutical goliath. They could not tell us why partially hydrogenated vegetable oil was not on the label, because the formula had not changed.

I'll tell you why. If GSK wanted to change the formula, they would probably have to put in a new application for FDA approval. It is much easier to change words on a label.

Does this surprise you?

D-deficiency doubles stroke risk in whites

Vitamin D deficiency does not appear to confer an increased risk of fatal stroke among blacks -- in contrast to findings among white populations, according to an analysis of U.S. population data. Analysis of National Health and Nutrition Examination Survey (NHANES) data encompassing almost 8,000 people, showed that over a median of 14 years, whites with levels of 25-hydroxyvitamin D level below 15 ng/mL had double the risk of dying from stroke compared with those who had higher levels. However, no such association was found in black NHANES participants -- despite their lower overall vitamin D levels and greater fatal stroke risk compared with whites. The finding was surprising because it was thought that vitamin D deficiency might explain the higher stroke rate observed in blacks. Johns Hopkins researchers speculated that African-Americans might have developed an adaptive resistance to the adverse effects of low vitamin D levels -- an idea supported by their lower rates of fractures and osteoporosis compared with whites. Sources of vitamin D include exposure to ultraviolet B rays in sunlight, as well as fatty fish, egg yolks, and fortified foods such as milk products and breakfast cereals.

Blood Sugar Imbalance, Diabetes Update

November is American Diabetes Month. Considering that public health experts predict that one in three US adults may have diabetes by 2050, we thought it prudent to pay homage by sharing with the you what we have learned recently.

Diabetic Retinopathy
A new study has found that patients with diabetic retinopathy, especially the proliferative type, are more likely to have insufficient serum vitamin D levels than people without diabetes, suggesting a link between vitamin D deficiency and one of the leading causes of blindness in adults. The findings were presented at the American Academy of Ophthalmology and Middle East Africa Council of Ophthalmology 2010 Joint Meeting.

Mean levels of 25-hydroxyvitamin D in adults with type 2 diabetes were well below 30 ng/mL, the cutoff the researchers used to define vitamin D "insufficiency" (deficiency). More than 75% of patients with diabetic retinopathy were deficient in vitamin D. They excluded patients with type 1 diabetes, vitamin D intake greater than 1000 IU/day, and disorders that change the metabolism of vitamin D. To minimize differences in sun exposure, the investigators performed vitamin D testing for all subjects from December 2009 through March 2010.

People with no eye disease had the highest serum vitamin D levels and those with proliferative retinopathy had the lowest levels (mean, 21.1 ng/mL).

After performing a linear multivariate analysis to control for potential confounders, the authors found only 1 factor that remained statistically significant: daily multivitamin use. "The use of daily multivitamins was somewhat protective against the development of vitamin D insufficiency," researchers said. However, even those who took daily multivitamins had a 44% incidence of vitamin D insufficiency because the mean intake of vitamin D from the multivitamins was less than the recommended daily intake of 400 IU.

Potential Link Between Obesity and Diabetes Explained?
Inflammation-causing cells in fat tissue may explain the link between obesity and diabetes. The discovery may open the way for new anti-inflammatory treatments that prevent insulin resistance (where the body is unable to respond to and use the insulin it produces) and other complications associated with obesity.

Macrophages, white blood cells derived from the bone marrow, are immune cells that normally respond to infections. In obese people, macrophages move into the fat tissue where they cause inflammation and release cytokines, which are chemical messenger molecules used by immune cells to communicate. Certain cytokines cause cells to become resistant to the effects of the hormone insulin, leading to diabetes and heart disease.

The findings, published in the journal Diabetes, provide the first evidence in humans that macrophages in the fat tissue are producing cytokines that prevent cells from appropriately responding to the presence of insulin. Encouragingly, the study also showed that when obese people lost weight the macrophages in the fat tissue disappeared, as did the risk of developing insulin resistance and diabetes.

If Harvard researchers are correct in their assumption that 42% of Americans will be obese before the epidemic reaches its peak (it is currently at 34%), the link to diabetes will get worse before it gets better.

Coffee, Tea, Alcohol and Risk of Diabetes in African American Women
The study included 46,906 Black Women's Health Study participants aged 30–69 y at baseline in 1995. During 12 y of follow-up, there were 3671 incident cases of type 2 diabetes. Intakes of decaffeinated coffee and tea were not associated with risk of diabetes. However, women who drank moderate amounts of caffeinated coffee or alcohol had a reduced risk of type 2 diabetes. American Journal of Clinical Nutrition, October 2010

Women With Polycystic Ovary Syndrome (PCOS) Improve With Low Glycemic Diet
Researchers compared changes in insulin sensitivity and clinical outcomes after similar weight losses after consumption of a low-GI diet compared with a conventional healthy diet in women with PCOS. Overweight and obese premenopausal women with PCOS consumed either a low-GI diet or a macronutrient-matched healthy diet and for 12 mo or until they achieved a 7% weight loss. Among completers, oral glucose-intolerance test improved more with the low-GI diet than with the conventional healthy diet. There was even greater improvement in the oral-glucose tolerance test among women prescribed both metformin and the low-GI diet. Compared with women who consumed the conventional healthy diet, more women who consumed the low-GI diet showed improved menstrual cyclicity (95% compared with 63%, respectively). Among the biochemical measures, only serum fibrinogen concentrations showed significant differences between diets. To the best of our knowledge, this study provides the first objective evidence to justify the use of low-GI diets in the management of PCOS.

Corticosteroid Use and Diabetes Risk
The use of inhaled corticosteroids, whether for asthma or chronic obstructive pulmonary disease (COPD), increases the likelihood of diabetes onset and diabetes progression, according to a study in The American Journal of Medicine. Systemic corticosteroids are known to increase diabetes risk, but the effects of inhaled corticosteroids are unknown. Of 388,584 patients newly treated for respiratory disease from 1990 to 2005 and followed through 2007, use of inhaled corticosteroids was associated with a significant 34% increase in the rate of diabetes. It translates into an additional 5 cases of diabetes per 1000 patients every year from the medication.

Father's Status at Time of Conception Linked to Diabetes Risk in Offspring
Medical researchers have for the first time shown a link between a father's weight and diet at the time of conception and an increased risk of diabetes in his offspring. The finding, reported in the journal Nature, is the first in any species to show that paternal exposure to a high-fat diet initiates progression to metabolic disease in the next generation. While researchers are aware that overweight women are more likely to have overweight babies, and that a woman's weight before and during pregnancy can play a role in future disease in her children, partly due to the critical role the intrauterine environment plays in development, the impact of the father's environment -- in terms of his diet -- on his offspring had not been investigated.

Paternal environmental factors such as diet and weight are important contributors to disease in the next generation. The research showed that overweight fathers can play a role in "programming" epigenetic changes in their offspring, possibly through effects on their sperm caused by their consumption of high-fat food.

Sugar-Sweetened Beverages Increase Risk of Diabetes
A new study has found that regular consumption of soda and other sugar-sweetened beverages is associated with a clear and consistently greater risk of metabolic syndrome and type 2 diabetes. According to the Harvard School of Public Health (HSPH) researchers, the study provides empirical evidence that intake of sugary beverages should be limited to reduce risk of these conditions. In the journal Diabetes Care, the researchers claim that many previous studies have examined the relationship between sugar-sweetened beverages and risk of diabetes, and most have found positive associations but their study provides an overall picture of the magnitude of risk and the consistency of the evidence.

The studies included more than 300,000 participants and 15,043 cases of type 2 diabetes and 19,431 participants and 5,803 cases of metabolic syndrome. The findings showed that drinking one to two sugary drinks per day increased the risk of type 2 diabetes by 26% and the risk of metabolic syndrome by 20% compared with those who consumed less than one sugary drink per month.

Potassium Deficiency, Diabetes Link
Serum potassium level is an independent predictor of incident type 2 diabetes mellitus, according to the Archives of Internal Medicine. Serum potassium levels affect insulin secretion by pancreatic β-cells, and hypokalemia associated with diuretic use has been associated with dysglycemia. Researchers hypothesized that adults with lower serum potassium levels and lower dietary potassium intake are at higher risk for incident diabetes, independent of diuretic use. Data from 12,209 participants who had 9 years of in-person follow-up and 17 years of telephone follow-up. showed that incident diabetes developed in 1475 participants during 9 years of in-person follow-up. Serum potassium level was inversely associated with the risk for incident diabetes, based on multivariate analyses. Compared with adults who had a high-normal serum potassium level, those with serum potassium levels less than 4.0 mEq/L, 4.0 to less than 4.5 mEq/L, and 4.5 to less than 5.0 mEq/L had a higher incidence of diabetes. During an additional 8 years of telephone follow-up, those with a serum potassium level of less than 5.0 mEq/L had a persistently increased risk for self-reported diabetes. Low dietary potassium intake was significantly associated with the risk for incident diabetes.

The association between increased risk of diabetes and low serum potassium levels seen in this cohort should be assessed in other populations.

Mediterranean Diet Halves Diabetes Risk
Use of the Mediterranean diet among nondiabetics at high cardiovascular risk halved the incidence of new-onset diabetes over four years compared with a low-fat diet. This is the first randomized clinical trial to look specifically at use of the Mediterranean diet for the prevention of diabetes, according to researchers of the study in Diabetes Care.

The diabetes risk reduction occurred in the absence of significant changes in body weight or physical activity, so the reduction can be attributed only to the diet, not to weight loss. Energy restriction was not advised in the trial, nor was physical activity promoted. The findings indicate that a non–energy-restricted traditional Mediterranean diet high in unsaturated fat could be a useful tool for preventing diabetes.

Aspirin Should Not Be a Primary Preventive Diabetes Therapy
According to US Pharmacist, low-dose aspirin remains a secondary prevention strategy in patients with diabetes and a history of CVD, yet it is no longer advocated as primary prevention for all patients aged 40 years and older with diabetes. Low-dose aspirin is now recommended for patients with an increased CV risk (10-year risk >10%), including men older than 50 years and women older than 60 years with at least one additional major risk factor. As far as we are concerned, there are other options besides pharmaceuticals that are just as effective than aspirin for this group.

The cost of food

Comparisons of the cost of different foods relative to their energy and nutritive value were conducted in the 1800s by the US Department of Agriculture (USDA). The objective of this American Journal of Clinical Nutrition study was to reestablish the relations between food cost, energy, and nutrients by using contemporary nutrient composition and food prices data from the USDA.

For 1387 foods, key variables were as follows: energy density (kcal/g), serving size (g), unit price ($/100 g), serving price ($/serving), and energy cost ($/kcal). A regression model tested associations between nutrients and unit price ($/100 g).

• Grains and fats food groups supplied the lowest-cost dietary energy.

• The energy cost for vegetables was higher than that for any other food group except for fruit.

• The highest prices per serving were for meats, poultry, and fish.

• The lowest prices per serving were for the fats category.

• Although carbohydrates, sugar, and fat were associated with lower price per 100 g, protein, fiber, vitamins, and minerals were associated with higher price per 100 g, after adjustment for energy.
  

• Grains and sugars food groups were cheaper than vegetables and fruit per calorie and were cheaper than fruit per serving.
  

These price differentials may help to explain why low-cost, energy-dense foods that are nutrient poor are associated with lower education and incomes.

PPIs increases C. Diff diarrhea

Proton pump inhibitor use was associated with an 80% increase in the risk of Clostridium difficile–associated diarrhea. Studies included 133,054 individuals. Overall, there was a significant increase in the risk of CDAD in patients taking PPIs. C. difficile represents an escalating threat to public health, and CDAD cost the United States an estimated $3 billion in 2005, researchers stated at the annual meeting of the American College of Gastroenterology.

Steve - I would venture to say that GI docs don't tell you about this risk before they prescribe PPIs.

If you do get diarrhea of any kind a multitude of research data shows the benefits of probiotics. According to a new review by Cochrane Collaboration, probiotic bacteria given as therapies for diarrhea reduce the length of time sufferers are affected and lessen the chance of episodes continuing for more than four days.

Probiotics may help in a variety of different ways including eliminating the bacteria, viruses or parasites responsible, for example, by competing for the same nutrients. Giving probiotics in conjunction with rehydration fluids reduced the duration of diarrhea by around a day and reduced the risk of diarrhea lasting four or more days by 59%. No serious adverse effects were reported in the trials.

Problem with painkillers during pregancy

Taking mild painkilllers such as aspirin, acetaminophen and ibuprofen during pregnancy, especially during the second trimester, can cause a sharp increase in reproductive problems in male offspring. The team found that women who used two of the drugs simultaneously during the second trimester were as much as 16 times as likely to bear a son with undescended testicles, a condition known as cryptorchidism. Cryptorchidism is known to be a risk factor for poor semen quality and testicular germ cell cancer in later life. The researchers demonstrated in rats that the drugs block the production of testosterone, which is necessary for the formation of male sex organs.

Researchers questioned 834 pregnant women in Denmark and 1,463 in Finland about their medication use, then examined their sons at birth. The Danish women received only a written questionnaire, while the Finnish women received both a written questionnaire and a phone interview. The women were more likely to say they had taken the painkillers in the phone interview, apparently not considering them to really be "medications."

The team found that women who used more than one painkiller simultaneously had a seven-fold increase in risk of having a son with cryporchidism compared with women who took nothing. The second trimester appeared to be particularly sensitive. Any painkiller use during this period doubled the risk of cryptorchidism. Ibuprofen or aspirin quadrupled the risk, while acetaminophen doubled the risk. Using more than one painkiller simultaneously led to a 16-fold increase in risk. Overall, the researchers said, the incidence of cryptorchidism in Denmark during the study was 8.5%, compared with 1.8% in a similar study in 1959 to 1961. "Moreover, this finding is in accordance with the reported decline in reproductive health in the adult male population in the last five decades," they wrote in their report in the journal Human Reproduction.

As part of the same study, other researchers found that the analgesics disrupted the production of androgenic hormones in rats, leading to an insufficient supply of the male hormone testosterone during the crucial early period of gestation when the male organs were forming. The effects were comparable to that caused by similar doses of known endocrine disruptors such as phthalates, whch are used in the manufacture of plastics like PVCs.

Bonnie - this so disheartening to read. I have been so vehemently against aspirin prescribed during pregnancy, which is such common practice. In two other studies related to pregnancy from the Am J Clin Nutr:

• The composition and development of infant gut microbiota are influenced by BMI, weight, and weight gain of mothers during pregnancy.
  
• Researchers found no association between mild caffeine intake during pregnancy and risk of preterm delivery.
  

While Warning About Fat, Govt Pushes Cheese

Steve - is this not par for the course. Ugh.

While Warning About Fat, U.S. Pushes Cheese Sales

Supplemental Calcium: Never Take Alone and Don't Overdo It.

According to a new study in the October 27th issue of British Medical Journal (BMJ), calcium supplements taken by themselves can increase the risk for myocardial infarction.

It is well known that calcium plus vitamin D supplements taken together prevent bone loss and reduce the risk for fracture in postmenopausal women and are associated with a reduction in the rate of bone mineral density loss at the spine and hip. More importantly, calcium plus vitamin D supplements reduce the overall risk for fracture by 12%. However, calcium by itself has not shown to be nearly as beneficial.

The researchers examined randomized, double-blind, placebo-controlled trials through November 2007 of elemental calcium at dosages of at least 500 mg per day. Researchers did not consider studies that combined supplements of calcium with vitamin D.

The main outcomes of the study were the time to first myocardial infarction, the time to first stroke, and the composite endpoint of myocardial infarction, stroke, or sudden death. The study included data on a total of 20,072 patients. The mean age of participants in these trials was 72 years, and 83% of subjects were women. The mean dose of calcium was slightly more than 1000 mg/day, and both calcium carbonate and calcium citrate were represented in the clinical trials.

Among trials with patient-level analysis, there were 143 and 111 myocardial infarctions among participants receiving calcium supplements and placebo, respectively. Individuals with higher dietary calcium intake appeared to be at a particularly elevated risk for myocardial infarction when taking calcium supplements. Calcium supplementation also appeared to promote a higher risk for recurrent cardiovascular events. There was no significant difference between calcium supplementation and placebo in the risks for stroke, the composite cardiovascular endpoint, or death.

The authors do discuss the major issue with their study. They only analyzed calcium supplementation without vitamin D supplements. Given that calcium supplementation appears most effective in reducing the risk for fracture when combined with vitamin D, the results of this study should not apply directly to most women receiving supplements for bone health. This is particularly salient given that a recent study found that vitamin D supplements at doses of approximately 1000 IU per day were associated with a lower risk for cardiovascular disease (whereas combination therapy with calcium plus vitamin D had no significant effect on the risk for cardiovascular outcomes).

Bonnie - if you are a client and have followed my advice, you should feel at ease because you are not taking supplemental calcium by itself. You are most likely taking a supremely absorbed calcium source along with gut-friendly magnesium and vitamin D3. Well before we started blogging about it (11/15/05, 2/16/06, 1/16/08), I warned that taking supplemental calcium by itself, as well as taking too much, was a bad idea. So the results of this study should not come as a surprise. If you have been supplementing with calcium by itself (especially in the carbonate or citrate form), then you are running the risk of rogue calcification, which can show up in the form of calcium deposits in the arteries.

If you are unsure of how much calcium, magnesium, and vitamin D you should be taking, contact your licensed health professional to individualize the amounts for your needs.

Calcium is an extremely beneficial mineral, but the requires the assistance of other vitamins and minerals to be put to beneficial use.

Coffee may slow liver disease

Drinking coffee could help slow the progression of fibrosis in patients with fatty liver disease, according to new research presented at the American Association for the Study of Liver Diseases' annual meeting. And a separate study presented at the same meeting found that patients with chronic hepatitis C who drank the most coffee and had failed standard treatment fared much better with retreatment. While the beneficial mechanism is not yet understood, these studies add to the number of beneficial studies that already existed.

Lifestyle intervention helps weight loss

Apart from bariatric surgery and pharmacotherapy, few clinical trials have evaluated the treatment of severe obesity. The objective of this study was to determine the efficacy of a weight loss and physical activity intervention on the adverse health risks of severe obesity.

The three year trial included 130 severely obese adult participants without diabetes. A one-year intensive lifestyle intervention consisting of diet and physical activity was implemented. One group (initial physical activity) was randomized to diet and physical activity for the entire 12 months; the other group (delayed physical activity) had the identical dietary intervention but with physical activity delayed for 6 months.

101 subjects completed the 12-month follow-up assessments. Although both intervention groups lost a significant amount of weight at 6 months, the initial-activity group lost significantly more weight in the first 6 months compared with the delayed-activity group. Weight loss at 12 months, however, was similar in the 2 groups. Waist circumference, visceral abdominal fat, hepatic fat content, blood pressure, and insulin resistance were all reduced in both groups. The addition of physical activity promoted greater reductions in waist circumference and hepatic fat content.

As suspected, among patients with severe obesity, a lifestyle intervention involving diet combined with initial or delayed initiation of physical activity resulted in clinically significant weight loss and favorable changes in cardiometabolic risk factors. JAMA 10/27/2010

Metagenics receives two patents

Metagenics Inc. received two new patents for its research on the anti-inflammatory properties of reduced iso-alpha acids (RIAA) derived from hops. U.S. Patent No. 7,794,757, “Modulation of Inflammation by Hops Fractions and Derivatives," was awarded for a proprietary method to reduce inflammation associated with pain using a formulation of hops derivatives that selectively inhibits the pro-inflammatory activities of the COX-2 enzyme without affecting the housekeeping activities of COX-2 (protection of the gastrointestinal lining), thus providing effective anti-inflammatory support with high degrees of predicted safety. U.S. Patent No. 7,807,203, “Anti-inflammatory Pharmaceutical Compositions for Reducing Inflammation and the Treatment or Prevention of Gastric Toxicity" was awarded for the application of a proprietary formulation of hops in preventing or treating disorders of the stomach and/or intestines that can lead to ulcers.

The discoveries were made by researchers at Metagenics’ wholly-owned biotechnology subsidiary, MetaProteomics® LLC. Inflammation is recognized as underlying factor in a wide range of chronic health conditions, including osteoarthritis, ulcers, autoimmune disease, low bone mineral densit, and metabolic syndrome. Rho iso-alpha acids derived from hops, say the researchers, modulate enzymes called kinases. Kinases perform a variety of tasks, including chemically modifying other proteins, regulating cellular pathways (particularly those involved in the transmission of signals within the cell), and regulating substances that can negatively impact health, including eicosanoids, cytokines and free radicals.

“We believe that our research opens the door to a new class of therapeutic agents that address inflammatory-related conditions at the cellular level" said Jeffrey S. Bland, Ph.D., FACN, Metagenics chief science officer and president of MetaProteomics.

Steve - contact us if you want to know what products have these ingredients included in them.

Fish oil no help to those with Alzheimer's

Daily supplements of docosahexaenoic acid (DHA) were ‘not useful’ in reducing cognitive decline associated with mild-to-moderate Alzheimer’s disease, says a new study from the Journal of the American Medical Association (JAMA). Researchers report that DHA at a dose of 2 grams per day did not affect cognitive and functional abilities after 18 months of supplementation.

The concern with this study is that it focused on supplementing DHA in individuals who were currently coping with Alzheimer’s disease. It didn’t answer the question of whether DHA—taken over long periods of time and several years prior to disease onset—could have helped prevent these participants from developing the disease. Further, the study only tested DHA under the assumption that it could be used as a treatment, which is highly unlikely given how little we know about Alzheimer’s disease.

The results echo those presented at the Alzheimer's Association 2009 International Conference on Alzheimer's Disease (ICAD 2009) in Vienna, which suggested that DHA may improve both memory function and heart health in healthy older adults, but the omega-3 had no general impact on the cognitive health of people with mild to moderate Alzheimer's.

Steve - for those with Alzheimer's, taking fish oil has myriad benefits. However, to use as a treatment to slow the decline is a bit of a stretch. Studying supplements like they do medications is the wrong approach. A study on fish oil's preventive benefits over a long period of time is what researchers should be focusing on.

One other aspect of the study that should be questioned is the subjects use of DHA derived from algae instead of fish.

Here is a study geared more to the effectiveness of fish oil: A study published in the November's Alzheimer's & Dementia: The Journal of the Alzheimer's Association suggests that taking docosahexaenoic acid (DHA) may improve memory and learning in older adults with mild cognitive impairments. A randomized, double-blind, placebo-controlled study to evaluate the effects of DHA -- the principle omega-3 fatty acid in the brain -- on improving cognitive functions in healthy older adults with age-related cognitive decline. The study found that DHA taken for six months improved memory and learning in healthy, older adults with mild memory complaints. While the MIDAS study focused on a population of healthy adults with age-associated memory impairment, a study recently published in the Journal of the American Medical Association (JAMA), conducted in a population that had previously been diagnosed with Alzheimer's disease, did not indicate DHA provided a statistically significant benefit to cognitive function. The lead author of the JAMA study also highlighted that their results may have been different had DHA been administered before the participants' disease progressed.

Babies anitibiotic use and risk of IBD

Babies treated with antibiotics for middle-ear and other infections may have increased odds of developing inflammatory bowel disease later in childhood, according a study in the American Journal of Gastroenterology. Among 36 children with either ulcerative colitis or Crohn's disease -- the two main forms of inflammatory bowel disease (IBD) -- 58 percent had been prescribed at least one course of antibiotics in the first year of life. In contrast, only 39 percent of 360 IBD-free children studied for comparison had taken antibiotics during their first year. The findings support the theory that factors affecting the early-life balance of "good" and "bad" bacteria in the intestines may contribute to IBD.

The researchers found that children with IBD were more likely to have been prescribed an antibiotic during the first year of life -- most commonly for middle-ear infections, but also for respiratory and other types of infection. Overall, antibiotic use in infancy was linked to a tripling of the risk of IBD relative to children who had no antibiotic prescriptions in their first year of life.

Pharma Execs to now face criminal charges

Courtesy of the Philadelphia Inquirer

Rats that infested a Philadelphia warehouse 40 years ago have found their way into the legal nightmares of the nation's drug companies. Frustrated that even billion-dollar fines seem to have little effect on pharmaceutical firms, the Food and Drug Administration has increasingly signaled its intent to use a legal doctrine spawned by those long-gone rodents to bring criminal charges against top executives, even those who might have been unaware of company misdeeds.

Earlier this month, Eric Blumberg, FDA litigation chief, told an industry audience that his agency was looking for cases to use what is known as the Park Doctrine as a tool to "change the corporate culture" of firms that have thus far shrugged off other penalties. In one area the FDA is targeting are companies that have illegally promoted products for unapproved uses, a practice know as off-label marketing. "I don't know when, where, or how many cases will be brought," Blumberg told a gathering of the Food and Drug Law Institute, "but if you are a corporate executive - or counsel advising such a client - I would not wait for the first case to decide now is the time to comply with the law. They won't get a mulligan on their conduct."

In an interview Thursday, Blumberg was pointed. "They need to take this seriously and find out what is going on in the marketing and sales divisions of their companies," he said of pharmaceutical executives. "In my view, one thing that will get executives' attention is a few cases in which we have convicted two-legged defendants." He singled out firms, including Pfizer Inc. and Eli Lilly & Co., that have paid multiple penalties in recent years. Eli Lilly, for instance, was hit with a $1.4 billion fine last year for illegally marketing Zyprexa, a antipsychotic drug. The same year, Pfizer was fined $2.3 billion for illegally marketing the pain reliever Bextra. Neither company's stock price suffered significantly, leading some to conclude that even massive fines are viewed by investors and executives as simply the cost of doing business. Neither firm responded to calls for comment.

"It is clear that fines are not working here," Blumberg said. "We need to put something else on the scale to make people think twice, three times, before they promote drugs for unapproved uses." That something is the threat of prison and industry debarment, which could result from a successful prosecution using the Park Doctrine. Under the Park Doctrine, a corporate officer is liable for illegal corporate actions the officer should have known about or was responsible for preventing. It stems from a case involving John Park, president of Acme Markets Inc. in 1970, when the company was cited for rodent infestations at a warehouse here. The FDA charged Park personally with violating sanitation laws after other rodent infestations were discovered despite a number of agency warnings. Park argued that as company president he was too far removed from warehouse supervision to be held responsible. The U.S. Supreme Court ultimately agreed with the FDA that Park, as president, was responsible for ensuring rodent-free warehouses. Park got off relatively easy: a $250 fine.

Prosecutors now hope to extract stiffer penalties under the doctrine, including up to a year in prison and $100,000 fines. Those are the possible punishments facing four executives of Synthes Inc., a West Chester firm that pleaded guilty early this month in connection with illegal clinical trials of a bone cement. Charged under the Park Doctrine by the U.S. Attorney's Office in Philadelphia, the executives have also pleaded guilty. The Park Doctrine can be "a very powerful tool," said Assistant U.S. Attorney John Pease, who supervises criminal prosecutions involving pharmaceutical-industry fraud cases in eastern Pennsylvania.

But it also presents prosecutors with a number of hurdles, he said. The crimes under scrutiny have a five-year statute of limitations, for instance. Often, prosecutors are not even alerted to them for several years, he said. "And with multinational pharmaceutical companies with billions in revenue, you find responsibility is very diffuse," Pease said. "The real challenge is finding a person who was in a position to know about and prevent the conduct that occurred." Scott Gottlieb, a former FDA commissioner who is now a partner with Arcoda Capital in New York, said another challenge would be assuring that an off-label case would hold up in court, particularly if it involved executives several layers above the departments that committed the illegal acts. "There are clearly cases where the management is so far removed from the activity, they have no direct knowledge of the issue," he said. "To hold them criminally liable is a significant policy step that needs to be done with great care." He agreed, however, that bringing criminal charges against executives "would be a significant deterrent."

James Prutow, a consultant to pharmaceutical companies on regulatory matters, said just the talk of charges had caught the attention of his clients. "Executives are really stepping back and asking, 'OK, how can we ensure that we are doing, both, the right thing as a company and also as individuals so we are not on the FDA's radar screen?' " Prutow, a partner with the management-consulting firm PRTM, said he expected that the FDA would bring a high-profile off-label case under the Park Doctrine sometime in the next six months. "When that happens, it really is going to wake people up," he said.

Bonnie - finally!