The USDA published its first nutrition guidelines in 1894 as a farmer’s bulletin. It recommended consuming a variety of nutrient-rich foods in proportion and moderation while lowering levels of fat, sugar, and starch intake. (Wikipedia, 2015)
Food Guides in the US 1894 -1920’s
A few of the United States’ earliest food guides, left to right: W. O. Atwater’s Food: Nutritive Value and Cost (1894), Caroline Hunt’s Food For Young Children (1916), Helen Atwater and Caroline Hunt’s How to Select Foods (1917)
In 1894, people were mostly eating REAL FOOD – there were no fast food franchises, highly processed foods, energy bars, sugar-filled carbonated soft drinks, genetically modified foods, factory farmed animals pumped full of antibiotics and fed GMO grains.
In the late 1970’s, the USDA nutritional guidelines reflected the new “low fat revolution”, urging Americans to reduce their intake of saturated fats and cholesterol – that is, to eat fewer traditionally healthy foods like eggs, butter, meat, and full-fat dairy. We now know that advice was seriously misguided and has been driving some of the world’s leading health threats – including obesity, diabetes, heart disease, and even cancer. (Gunnars, 2014)
The food industry responded to the new low fat guidelines by creating a slew of low fat “health foods”. Unfortunately, removing the fat from food also takes away its taste. So the industry replaced the missing fat with sugar. If you eat processed or fast foods and/or drink sodas or juice drinks, you’re consuming massive amounts of sugar in various forms.
Dr Stephan Guyenet, a neurobiologist and obesity researcher, says, “In the year 1822 we ate the equivalent of a 12 ounce can of soda every 5 days. Today, we’re eating the equivalent of a 12 ounce can of soda every 7 hours.”
“On average, Americans are eating about 22 teaspoons of added sugar per day, or 355 calories. This amounts to 70 pounds (32 kg) per year. Keep in mind that these are averages. Young males are eating about a 100 pounds of sugar per year… and many individuals are eating much, much more. (Gunnars, 2014)
Most processed foods, including ones calling themselves “health foods” contain sugar – often lots of it under various names. Among the ones to look for are:
Cane juice crystals
Cane juice solids
Corn syrup solids
Dehydrated cane juice
Dehydrated fruit juice
Fruit juice concentrate
Fruit juice crystals
High fructose corn syrup
– Colquhoun& ten Bosch, undated
This useful infographic from Dr Robert Mercola’s Newsletter lists the amount of sugar per 100 grams found in some common foods. As Mercola points out, sugars now constitute the majority of calories in most people’s diet. (Mercola, 8/31/2015)
I highly recommend watching the film. Here’s Fed Up‘s home page.
Note added on 9/1/2015:
A comment from Na’ama Yehuda (see Comments, below) reminded me to stress that not all sugars are equal. The sugars that occur naturally in fruit and dried fruit are a lot healthier for us than any form of refined sugar. As Na’ama says, concentrate on eating REAL FOOD, avoid processed junk foods filled with refined sugars and other unhealthy ingredients, and limit your total consumption of sugar.
Updated 8/29/2014, 9/7/2015, and 4/15/2016. NOTE added at end of post on 9/6/2015. Last updated 10/22/2016.
In the global diabetes epidemic, rates of new cases are rising rapidly. I hope this post will help you avoid becoming one of them.
Number of People Diagnosed with Diabetes
Millions, by region
Source: IDF Diabetes Atlas, Sixth Edition; Managed Care calculation of percentages using data from The World Factbook, published by the CIA
TYPES 1 & 2 DIABETES: AUTOIMMUNE DISEASES
During digestion, most of our food gets broken down into glucose (a form of sugar that’s the body’s main source of fuel), which then passes into the bloodstream. Insulin (a hormone produced by the pancreas) must also be present in the blood for glucose to be able to make it into our cells to nourish them.
Type 1 diabetes is known to be a serious autoimmune problem of the metabolism. An autoimmune disorder or disease is a result of chronic inflammation in the body’s immune system, causing it to turn against a part of the body – to attack it as if its cells were dangerous, invading pathogens. In Type 1 diabetes, the immune system attacks and destroys the insulin-producing cells in the pancreas. (WebMD, 2008)
Type 2 diabetes is now also largely viewed as the result of a different type of autoimmune reaction: one in which B and T immune cells cause inflammation in the fatty tissue surrounding organs in the body. The inflammation occurs when rapidly growing fat cells outstrip their blood supply and begin to die off. These dying cells spew out their contents, and macrophages (another type of immune cell) are called in to clean up the dead cells. “The resulting onslaught by the immune system inhibits the ability of the remaining fat cells to respond to insulin and causes fatty acids to be shed into the blood. This sets in motion a physiological cascade that leads to fatty liver disease, high cholesterol, high blood pressure and further insulin resistance throughout the body.” (Conger, 2011)
TYPE 1 DIABETES
In Type 1 diabetes, which used to be called juvenile diabetes, the immune system mistakenly kills off pancreatic cells that make the blood-sugar-regulating hormone insulin. The body’s immune system attacks and destroys these pancreatic cells so they no longer make enough insulin.
Type 1 diabetes accounts for about 10% of diagnosed diabetes in the US.
TYPE 2 DIABETES
In Type 2 diabetes, the pancreas usually produces enough insulin but the cells in the body have become unable to make effective use of the hormone, a condition called insulin resistance. Insulin production eventually decreases. So, as in Type 1 diabetes, glucose builds up in the blood instead of being properly delivered to the cells in the body where they’re needed for fuel.
Type 2 diabetes is associated with obesity, older age, family history of gestational diabetes, and physical inactivity. About 80% of people with Type 2 diabetes are overweight. Unfortunately, Type 2 diabetes is also increasingly being seen in younger people, even children and teens.
A prediabetic condition indicates the amount of glucose in the blood is above normal but not yet high enough to be called diabetes. Prediabetic people are at greater risk of developing Type 2 diabetes, heart disease, and stroke.
DIABETES STATISTICS IN THE US
Statistics from the American Diabetes Association Report, 2014 show the magnitude of the problem in the US:
PREVALENCE: In 2012, 29.1 million Americans, or 9.3% of the population, had diabetes.
Approximately 1.25 million American children and adults have type 1 diabetes.
UNDIAGNOSED: Of the 29.1 million, 21.0 million were diagnosed and another 8.1 million were undiagnosed.
PREVALENCE IN SENIORS: The percentage of Americans age 65 and older remains high, at 25.9%, or 11.8 million seniors (diagnosed and undiagnosed).
NEW CASES: The incidence of diabetes in 2012 was 1.7 million new diagnoses/year; in 2010 it was 1.9 million.
PREDIABETES: In 2012, 86 million Americans age 20 and older had prediabetes; this is up from 79 million in 2010.
DEATHS: Based on the 69,071 death certificates in which diabetes was listed as the underlying cause of death in 2010, diabetes was the 7th leading cause of death in the United States that year. In 2010, diabetes was also mentioned as a cause of death in a total of 234,051 certificates.
CAUSE OF DEATH UNDER REPORTING
Diabetes may be under reported as a cause of death. Studies have found that only about 35% to 40% of people with diabetes who died had diabetes listed anywhere on the death certificate and only about 10-15% had it listed as the underlying cause of death.
DIABETES IN YOUTH
About 208,000 Americans under age 20 are estimated to have diagnosed diabetes, approximately 0.25% of that population.
In 2008—2009, the annual incidence of diagnosed diabetes in youth was estimated at 18,436 with Type 1 diabetes, 5,089 with Type 2 diabetes.
Some other diabetes statistics showing the seriousness of the problem:
Below are diabetes prevalence data from the US Centers for Disease Control and Prevention. The number of reported cases tripled between 1980 and 2008. The CDC estimates that “the number of Americans with diabetes will range from 1 in 3 to 1 in 5 by 2050.”
And here’s information from the International Diabetes Federation comparing reported cases of diabetes in 2013 with projected cases by 2035 for countries around the world – an expected increase of 55%.
GUT BACTERIA & DIABETES
Researchers are discovering changes in normal gut bacteria that take place before either Type 1 and Type 2 diabetes turns into a clinical condition. Since we now know that 70-80% of our immune system is located in our GI tract, where digestion takes place, you can see how a serious imbalance in the bacterial make up of the gut microbiome could lead to the development of diabetes in people with a genetic predisposition for it.
“Mounting evidence suggests that the bacteria resident within our GI tract – and the immune response to those bacteria – influence the permeability of the gut mucosa. This idea — which has become to be known as the “leaky gut” hypothesis — proposes that a cycle of dysbiosis, dysregulated immune response, and unintended gut permeability leads to the peripheral host immune system being unbalanced towards a pro-inflammatory response. This in turn is suggested to lead to (some of) the imbalances that are thought to be causative of diabetes and other non-metabolic disorders.” (Moore, 2015)
GUT BACTERIA, ANTIBIOTICS & RISK FOR DIABETES
A team of scientists led by Dr Ben Boursi, a Post Doctoral Researcher in Gastroenterology at the University of Pennsylvania in Philadelphia, found people who have taken multiple courses of antibiotics were 37% more likely to develop Type 1 and Type 2 diabetes. The team also found the greater the number of courses of antibiotics, the higher the risk for developing diabetes.
Dr Boursi notes, “Our findings are important, not only for understanding how diabetes may develop, but as a warning to reduce unnecessary antibiotic treatments that might do more harm than good.”
Several studies in humans have shown that early childhood exposure to antibiotics is associated with increased risk of obesity in later life – and obesity has long been recognized as risk for developing diabetes.
There’s also growing evidence that imbalances in the gut microbiome’s composition contribute to the development of both Type 1 and 2 diabetes.
The Boursi team’s future research will focus on identifying the species of gut bacteria necessary to prevent and reverse diabetes, potentially working towards the possibility of transplanting prebiotic and probiotic microbes into the gut as a therapeutic strategy for diabetes. (Arendt, 2015) & (Davenport, 2015)
PREDIABETICS HAVE FEWER & LESS DIVERSE GUT BACTERIA
A research team led by Dr Elena Barengolts, an Endocrinologist at the University of Illinois College of Medicine, found irregularities in the composition of the probiotic bacteria in the guts of prediabetic patients: Compared with subjects whose glucose tolerance was good, the prediabetics had fewer and less diverse populations of bacteria living in their gut microbiomes.
There were 116 participants in the study, all African-American veterans. Their ages ranged from 45 to 70. Their intestinal bacteria were measured by stool samples at the start of the study and again 12 months later.
Participants were divided into four groups based on their body’s ability to regulate blood sugar:
Group 1 – Those with stable glucose tolerance (normal)
Group 2 – Those with stable impaired fasting glucose or stable impaired glucose tolerance
Group 3 – Those with worsened glucose tolerance
Group 4 – Those with improved glucose tolerance
The study found that men whose blood sugar control remained normal over the year (Group 1) had higher numbers of beneficial gut bacteria while the men who continued to be prediabetic had fewer beneficial bacteria and higher numbers of harmful bacteria in their guts.
Furthermore, the group whose blood sugar management improved over the course of the year (Group 4) had a higher number of a strain of healthy bacteria (Akkermansia) than the group who had maintained normal blood sugar control over the year (Group 1). (Gray, 2015)
At the phylum level, this study found significant differences in the bacterial composition between Groups 1 and 2: Group 2 (people with impaired but stable fasting glucose or glucose tolerance) had higher levels of Bacteroidetes and lower levels of Firmicutes than people in Group 1.
The Bacteroidetes/Firmicutes ratio was 1.9 vs 0.9 respectively for Groups 1 and 2 and 1.9 vs 1.1 respectively for Groups 1 and 3.
The number of Proteobacteria decreased over the 12-month study period in Groups 2 and 4 compared with Group 1. Proteobacteria are a major phylum of gram-negative bacteria that include a variety of pathogens – such as Escherichia, Salmonella, Vibrio, Helicobacter, and Yersinia. (Wikipedia, 2015)
At the family and genus levels, Group 2 had fewer Prevotella and a higher Bacteroides/Prevotella ratio than Group 1: 5.6 vs 2.7. Group 2 also had fewer Enterobacteriaceae (a large family of bacteria that includes the pathogens Salmonella, Escherichia coli, Yersinia pestis, Klebsiella and Shigella) and more Ruminococcae and Veillonellaceae.
“We speculate that lower abundance of Prevotella may be associated with worsening glycemia, and, conversely, higher abundance of Akkermansia might be associated with improving glycemia, thus corroborating suggestions from previous studies,” the researchers said.
Barengolts notes, “Changes in the gut microbiota occur in the early stage of diabetes development. The gut bacteria signature — the composition and abundance — could be a useful tool in assessing a person’s risk for developing obesity and diabetes.” (Ciubotaru et al, 2015) & (Brown, 2015)
Other studies are currently underway in Italy and China investigating gut bacterial transplants as a treatment for diabetes.
ALTERED GUT BACTERIA PRECEDE TYPE 1 DIABETES IN CHILDREN
A small study followed 33 babies from Finland and Estonia who were at increased genetic risk for developing Type 1 diabetes. Analysis of their stool samples charted changes in the multitude of microorganisms living in their guts.
By age three, four of the children developed Type 1 diabetes. Huge alterations in the gut microbes of those those four children were seen about a year before onset of the disease. As with the men in the veterans’ study, there was a marked drop in the diversity of the overall microbial community. This drop in gut diversity was accompanied by spikes in inflammation-favoring organisms, gene functions, and serum and stool metabolites. These changes in gut microbial levels did not occur in the at risk children who didn’t progress to Type 1 diabetes.
Researcher Dr Aleksandar Kostic, a Postdoctoral Fellow in Computational Biology and Experimental Biology at MIT and Harvard, hopes the study’s results will lead to an early diagnostic test for Type 1 diabetes. (Kostic et al, 2015) & (Norton, 2015)
PREVENTING & TREATING DIABETES VIA THE GUT MICROBIOME?
Bacteria in the Human Gut
Given what we already know about the gut microbiome’s role in keeping the body in a balanced state so it remains healthy, it makes sense to focus on diet and nutritional supplements for preventing and treating diabetes.
For example, we know there is considerable variation among people in the microbes that live in and on us. We also know that an individual’s microbial populations are always changing.
The following is from an easy to read summary of changes in the various human microbiomes from birth through old age. It was prepared by the University of Utah’s Genetic Science Learning Center (2015). You might want to take a look at it – it provides useful information along with some delightful drawings:
“Before birth, we’re all more or less sterile—we have no microbes. Within a few years, we’re covered in thousands of different species of microbes, and they colonize every millimeter of the body that’s exposed to the outside world. By the time we enter kindergarten, we have vastly different populations living in the different habitats around our bodies. Even as adults and into old age, our microbiota continue to shift.
” … Because so many things affect our bodies’ ecosystems, there is a huge amount of variability in microbial populations even among individuals of the same age. Just like our fingerprints vary, we vary in the microbial species we have as well as their relative abundancies. Our microbes vary with gender, diet, climate, age, occupation, and hygiene. Even differences in our genes influence our microbial populations—indirectly by affecting things like the acidity of the digestive tract, and also more directly through variations in proteins on our cells that communicate with microbes.
“Even with all this variability, there are some trends. Microbial populations differ more among body sites than between individuals. For example, the microbes living on the forearms of two different people tend to be more similar than the microbes on the forearm and ear of the same person. And there are certain species of bacteria that will only live in the gut, others that will live only on the teeth, and so on.”
GENETICS VS EPIGENETICS
We also know this about autoimmune diseases: DNA IS NOT DESTINY
Chronic diseases, especially autoimmune ones, are only 25% determined by genetic inheritance. The other 75% is affected by other factors. It’s a matter of genetics vs epigenetics. You may have a genetic predisposition for diabetes but also have a large say in whether your DNA expresses that predisposition in your body.
“We know from twin studies, from identical twin studies, that 25% of autoimmunity is your genetics, and 75% is from the environment. … So that’s an enormous amount that we have control over and can influence.”
Amy Myers, MD. (Sanfilippo, 2015)
If we know that both the composition and abundance of micro-organisms living in our guts change over the course of a lifetime, shouldn’t it be possible to learn how to make deliberate changes to our gut microbiome – changes that prevent diabetes from developing even if we have a genetic predisposition for it?
TO AVOID OR REVERSE INSULIN RESISTANCE
These are Dr Robert Mercola’s suggestions for turning insulin resistance around (Mercola, 8/23/2015) & (Mercola, 8/27/2015):
EAT REAL FOODS INSTEAD OF PROCESSED ONES
Almost all so-called foods that come in a bottle, can, jar, bag, or box have had sugars added to them, usually in the form of high fructose corn syrup.
EAT FRESH FRUIT INSTEAD OF PURCHASED FRUIT JUICES
Commercial fruit juices are loaded with added sugar.
AVOID “DIET” FOODS AND DRINKS
They promote insulin resistance and other health problems. “The artificial sweeteners saccharin, sucralose, and aspartame decrease function in pathways associated with the transport of sugar in your body, and can induce both gut dysbiosis and glucose intolerance. Research also shows that artificial sweeteners promote diabetes and weight gain by disrupting your gut microbiome. Sucralose (Splenda) was found to reduce beneficial gut bacteria by as much as 50 percent!”
AVOID GRAINS, ESPECIALLY WHEAT, BARLEY, OATS & RYE
Grains turn into sugar in your body, sharply raising your glucose and insulin levels, and contribute to insulin resistance. Many grains also contain gluten, which triggers inflammation in the intestines, leading to a state of chronic inflammation in the body and autoimmune diseases.
Consuming a lot of refined grains (and even whole grains) is also highly inflammatory for another reason: Humans are designed to eat a diet containing a ratio of 1 or 2 parts of Omega-6 essential fatty acids to every 1 part of Omega-3. This ratio is what we get when we eat real, unprocessed, highly nutritious foods – non-GMO veggies, fruits, nuts, seeds, and pastured animals. Our typical diet now has come to contain 10 to 20 parts Omega-6 to every part Omega-3 – producing a highly inflammatory state in the body. (Kratka, 2011)
“Grains are almost single-handedly responsible for the removal of omega-3 fatty acids in the modern diet…. There have been over 2000 studies done on omega-3 and for good reason: the omega-3s in our diet (or the lack their of) have massive implications on our health. It all boils down to ratios: the ratio of omega-3 to omega-6 fatty acids in your diet is so crucial, it goes down to the cellular level.” (Kratka, 2011)
Better alternatives to grains are non-GMO almond meal, coconut flour, buckwheat groats, and sweet potatoes. They are much gentler on your blood sugar than grains. Mercola points out that even these healthier alternatives will hamper your body’s ability to heal if you’re already insulin resistant. “Once the clinical signs of insulin resistance have resolved, you can relax your carb restriction.”
Eat fewer saturated and trans fats (unhealthy) and more mono and poly unsaturated fats (healthy). Examples of healthy fats include avocado, butter made from raw grass-fed organic milk, cheese, raw dairy, organic pastured eggs, raw nuts, grass-fed meats, and coconut oil.
Due to the high percentage of nutrient-poor foods, refined carbohydrates, bad fats, and refined sugars in the Standard American Diet (SAD), along with consumption of multiple OTC and prescription pharmaceuticals, we are far from getting the optimal ratio of 1:1 for Omega-6s (inflammatory) and Omega-3s (anti-inflammatory). The ratio in our modern Western diet is often as high as 20:1, creating excessive, chronic inflammation in the body – and chronic inflammation is a precursor to many diseases.
GET ENOUGH VITAMIN D3
Having a sufficient blood level of Vitamin D is essential for maintaining good health and preventing a wide range of autoimmune and neurological diseases: Type 1 and 2 diabetes, asthma, allergies, cancer, Alzheimer’s, MS, susceptibility to infection (including viral respiratory infections) among them.
Vitamin D3 is vitally important for healthy immune functioning – and most of us are seriously D3 deficient. Unless we work mostly naked outdoors in a sunny climate without slathering our skin with sunscreen, we can benefit greatly from adding a high quality D3 supplement to our daily diets.
Some good sources of Vitamin D3 are:
Exposure of the skin to sunshine (without sunscreen), salmon, tuna, mackerel, sardines, cod liver oil, egg yolks, cheeses, butter, shiitake and button mushrooms, sunflower seeds and sprouts, and high quality supplements.
Guidelines for the Recommended Daily Allowance (RDA) of vitamin D were updated by the Institute of Medicine (IOM) in 2010 and are currently set by age: For those 1-70 years of age, 600 IU daily; for those 71 years and older, 800 IU daily; and for pregnant and lactating women, 600 IU daily. This is thought by many as far too low.
Due to a mathematical error, the IOM’s widely cited RDA’s for Vitamin D underestimate the body’s need for it by a factor of 10.
The IOM recommends a Vitamin D serum level of 20 ng/ml but we should actually aim for a blood level of 40 ng/ml, supplementing with whatever amount is necessary to reach and maintain that level. (Mercola, 5/10/2015)
One of my alternative health care providers recommends 5,000 IU/day in the summer time and as high as 10,000 IU/day the rest of the year. (Miller, 2011). I like Metagenics, D3 5000, 120 Softgels (1 2X/day).
Vitamin D serum levels should be monitored with periodic blood tests.
(4/15/2016: I reduced my D3 intake to 5,000 IU/day after my D blood serum level was too high.)
(10/22/2016: A few months ago, I needed to reduce my D3 intake even further – to 5,000 IU/day during the darker months and the same amount every other day during the sunnier months.)
Over 10,000 studies show that prolonged sitting harms your health. 8-10 hours of sitting a day, even if you exercise 30-60 minutes daily and are very fit, promotes dozens of chronic diseases – including obesity and Type 2 diabetes.
“The reason for this is because, at the molecular level, the human body was designed to be active all day long. When you stop moving and sit still for extended periods of time, it’s like telling your body to shut down and prepare for death. As soon as you stand up, a number of molecular cascades occur that promote and support healthy biological functioning.
“For example, within 90 seconds of standing up, the muscular and cellular systems that process blood sugar, triglycerides, and cholesterol — which are mediated by insulin — are activated. Surprising as it may sound, all of these molecular effects are activated simply by carrying your body weight upon your legs. These cellular mechanisms are also responsible for pushing fuels into your cells and, if done regularly, will radically decrease your risk of diabetes and obesity.
“So, the remedy is simple: Avoid sitting and get more movement into your life. Ideally, aim to sit less than three hours a day. Also consider walking more, in addition to your exercise regimen. In short, rest is supposed to break up activity — not the other way around. This kind of non-exercise physical movement appears to be really foundational for optimal health, and if you’re currently inactive, this is the place to start even before you get going on a workout routine.” (Mercola, 8/23/2015)
Don’t let this be true for you:
NOTE ADDED ON 9/6/2015
I’d asked Warren Fraser, MD, to look over this post. Dr Fraser is an experienced board certified endocrinologist and Co-Chair of the Institutional Review Board at Pennington Biomedical Research Center in Baton Rouge, LA. He sent these helpful comments:
I think your post is very good.
I hadn’t thought of autoimmune diseases as being a result of chronic inflammation, but it makes sense. It’s seems as if more and more disorders are being linked to chronic inflammation. Cardiovascular disease has, and one of the studies I reviewed this week is looking at a drug which reduces chronic inflammation (the drug is already approved for use in Juvenile Rheumatoid Arthritis, now commonly called Juvenile Idiopathic Arthritis) to see if it will lower the incidence of a second cardiovascular event in people who have had one heart attack.
In reference to the TYPE 2 DIABETES SECTION:
The pancreas actually over secretes insulin in the early phases of the disease to combat the insulin resistance. This was quite a surprise to investigators when the insulin assay was developed (late 60’s or early 70’s I think). As you pointed out, insulin production eventually decreases, which may be due to, at least in part, pancreatic ‘exhaustion’ from chronic hypersecretion. High insulin levels are almost always seen in prediabetes (insulin resistance syndrome) and measuring insulin levels is useful in making the diagnosis.
In reference to the section on DIABETES STATISTICS IN THE US:
The increase in new cases may be due in part to a greater awareness of the disorder and more people being tested for it.
I certainly concur that diabetes is under reported as a cause of death. The cause is often attributed to a complication of the diabetes. Back in the 80’s, when Lee Iacocca addressed the annual meeting of American Diabetes Association, he said that he wanted his wife’s death certificate to tell the truth: she died from diabetes.
In reference to the section on GUT BACTERIA, ANTIBIOTICS & RISK FOR DIABETES:
I certainly agree with the harmful effects of excessive antibiotic use.
Again, this is a very good review and my comments aren’t meant to be suggestions to change anything.
– Fraser, 2016
GMO vs NON-GMO FOODS:
In the section AVOID GRAINS, ESPECIALLY WHEAT, BARLEY, OATS & RYE, I’d written “Humans are designed to eat a diet containing a ratio of 1 or 2 parts of Omega-6 essential fatty acids to every part of Omega-3. This ratio is what we get when we eat real, unprocessed, highly nutritious foods – non-GMO veggies, fruits, nuts, seeds, and pastured animals. Our typical diet now has come to contain 10 to 20 parts Omega-6 to every part of Omega-3 – producing a highly inflammatory state in the body.”
Dr Fraser also asked for clarification on the meaning of “non-GMO”. Here it is with respect to the foods we consume:
The short answer is that NON-GMO plant foods are ones that have not been genetically modified and NON-GMO animals are ones that have not been fed genetically engineered grains or other plants.
GMO foods have been genetically engineered, for reasons completely unrelated to health or nourishment, to withstand heavy applications of potent herbicides like Monsanto’s Roundup (a glyphosate-based weed killer). GMOs are created using the gene-splicing techniques of biotechnology to inject DNA from one species into another species, creating combinations of plant, animal, bacteria, and viral genes that don’t occur in nature or through crossbreeding methods.
Glyphosate causes serious damage to the beneficial microbes living in our guts (our gut microbiome) and is regarded by many scientists as the most important factor in the development of the many chronic diseases and conditions plaguing Westernized societies.
The process of genetically modifying foods is relatively new in agriculture. The first genetically modified seeds for commercial use were planted in the US in 1996. In 2014, 18 million farmers in 28 countries planted biotech crops, with the highest acreage by far here in the US. Worldwide planting of GE crops covered 181.5 million hectares (448 million acres) by 2014.
The Center for Food Safety estimates that about 3/4 of all grocery store products now contain one or more genetically modified ingredients.
England, France, Germany, New Zealand, Switzerland, China, Indonesia, and more than 25 other countries around the world require GE foods to be labeled so consumers can choose to avoid them. England, Japan, Brazil, Norway, India, Thailand and some other countries have even completely banned some GE food crops.
Monsanto and the other big biotech companies have joined together to spend huge sums of money to make sure these GMO foods remain unlabeled in the US.
The American Academy of Environmental Medicine (AAEM) has declared genetically engineered food unsafe for consumption. They cited animal studies indicating serious health risks associated with GM foods – “including infertility, immune problems, accelerated aging, faulty insulin regulation, and changes in major organs and the gastrointestinal system. The AAEM advised physicians to tell their patients to avoid GM foods.
“Before the FDA decided to allow GMOs into food without labeling, FDA scientists had repeatedly warned that GM foods can create unpredictable, hard-to-detect side effects, including allergies, toxins, new diseases, and nutritional problems. They urged long-term safety studies, but were ignored.” (Institute for Responsible Technology, 2014)
Studies of people in the US and Germany have found high levels of glyphosate in human urine, blood, and breast milk as well as in drinking water supplies.
Kostic, A.D. et al. (2015). The dynamics of the human infant gut microbiome in development and in progression toward type 1 diabetes. Cell Host & Microbe, 17:2, 260-273. See: http://www.ncbi.nlm.nih.gov/pubmed/25662751
I learned something very helpful from my recent thermography. After weeks of intense intestinal distress, I now know (at least in part) what the cause was and how to fix it.
Turns out my symptoms (bloating, burping, gas, feeling full after eating only a little, abdominal pain, fever spikes, spastic diarrhea, insomnia – feeling weak, toxic and just generally awful) were due in large part to my pyloric and ileocecal valves’ having become sluggish. What a relief to get this information. And the fixes works quickly: I feel better immediately after doing them!
We’ll get to these shortly, but first some information on the functions of those valves and what can go wrong if they’re not working properly.
The pyloric valve is a sphincter-type valve that controls the opening between the bottom end of the stomach and the beginning of the small intestine. It’s located about 2″ above the navel, more or less in the center of the body.
The pyloric valve’s principal function is to control the flow of partially digested material from the stomach into the duodenum, the topmost section of the small intestine, where most of the nutrients get extracted from what we eat. When the valve is working well, it opens slightly a few times a minute to allow a small amount of food to move into the duodenum. Its secondary function is to prevent bile from flowing back from the small intestine into the stomach (bile reflux).
When the pyloric valve is malfunctioning, as it does in many people – even some who aren’t aware they’re having a problem, it creates discomfort and many serious medical problems. Malfunctioning of this valve includes spasms that prevent it from opening or closing completely.
Bloating: Symptom of a Pyloric Valve That Isn’t Opening Properly
When the valve spasms, it becomes inflamed. You can experience pain as food tries passing from your stomach into your small intestine. If the spasms are severe, you may become nauseated and experience violent vomiting as your stomach attempts to clear itself. The usual symptoms of a spastic pyloric valve that isn’t opening properly are bloating and a sharp pain after eating.
If the valve isn’t closing properly, bile can flow back into the stomach from the intestines. The Mayo Clinic says, “Bile reflux can be difficult to distinguish from acid reflux…. and the two conditions may occur at the same time.” Bile reflux can lead to some serious issues, including damage to the stomach and esophageal linings, bleeding ulcers, and Barrett’s Esophagus. (Thermal Imaging of the Southwest, 2013)
Bile Reflux: Symptom of a Pyloric Valve That Isn’t Closing Properly
“When the (pyloric) sphincter is contracted, it holds food in the stomach, allowing the digestive juices to do their work. This breaks down the food into a substance called “chyme.” Once the food has broken down, the sphincter opens and allows it to enter the duodenum. The time the food spends in the stomach allows the body to absorb more of the nutrients.
“As long as the sphincter is healthy, it serves as a one-way door to the intestines, and that keeps your digestive system moving smoothly.”
– New Health Guide, 2014
The malfunctioning, constricted pyloric valve shown on this thermogram is visible inside the black oval in the center of the body:
Thermogram of a Pyloric Valve in Distress
When the pyloric valve is constricted and inflamed, blood flow increases to that area. When the valve doesn’t close properly, allowing bile to flow back into the stomach and attack the stomach lining, blood flow to this area increases. It is the increased heat in the distressed area, caused by this additional blood flow, that the thermographic infrared camera captures on the image.
“Dr. Gregory Melvin, a board-certified thermography-reading doctor, notes that ‘Most conditions are detectable with infrared imaging. When the pyloric valve is under distress, it creates a specific and unique thermal image, making it fairly obvious.’” (Thermal Imaging of the Southwest, 2013)
The ileocecal valve is a sphincter-type valve located at the junction of the end of the small intestine and beginning of the large intestine. Its purpose is twofold: 1) To retain the contents of the small intestine long enough for the digestive process to be completed, and 2) As a barrier to prevent bacteria laden material in the large intestine from ‘back flowing’ into the small intestine and contaminating it.
When the ileocecal valve is closed, the partially digested food stays in the small intestine, where the body renders and absorbs nutrients. Once material has been allowed to pass through the ileocecal valve to enter the large intestine, the valve closes again to prevent back flow from the large intestine.
HEALTHY FUNCTIONING OF THE ILEOCECAL VALVE
When the ileocecal valve is functioning normally:
It remains closed most of the time, opening only when food is ready to pass from the small intestine into the large intestine for further processing.
It opens briefly to allow the contents of the small intestine to exit into the large intestine.
After food has moved through it, it closes again quickly to prevent contents of the large intestine from leaking back into the small intestine.
WHEN THE ILEOCECAL VALVE MALFUNCTIONS – REMAINING OPEN OR CLOSED
An ileocecal valve sticking in the open position allows a backwash of watery waste material from the large intestine to get absorbed back into the small intestine. This is serious because the small intestine is where the process of creating blood to fuel the body begins.
A valve stuck in the open position can cause frequent diarrhea leading to dehydration and lack of energy
A valve sticking in the closed position can cause tightness in the bowel movements or constipation.
Both conditions create a toxic condition and cause imbalances anywhere in the body where there is blood. (Minckler, undated) (Pollard, undated)
Dysfunction of the ileocecal valve, remaining either open or closed, causes organs and/or muscles to become more susceptible to developing problems.
A person with an open valve will feel better when stationary and worse when moving around. Someone with a closed valve will feel worse upon rising or being inactive and better when moving around. (NeuroHealth Chiropractic, 2013)
FACTORS AFFECTING ILEOCECAL VALVE FUNCTIONING
Consuming insufficient nutrients
An improper nerve supply
Misalignment of the joints
Not chewing food well enough
– Pollard, undated
DIETARY TIPS TO KEEP YOUR ILEOCECAL VALVE WORKING WELL
Some foods to avoid:
Bread and other dense foods to help keep it from sticking
Spicy and sugary foods
Supplements that support the functioning of the whole digestive system include:
AFA blue green algae
– Earthclinic, 2015
“This very important anatomical structure does an unheralded job. The Ileocecal Valve is such a major cause of digestive symptoms for people that the problem has reached epidemic proportions; yet, outside the chiropractic profession, its function and importance are practically unknown.
“Problems with an open ileocecal valve (Ileocecal Valve Syndrome) are extremely common in today’s society yet its symptoms are often misdiagnosed. Very few health practitioners understand the significance of the ICV in digestive problems.” (Pollard, undated)
Image of a Healthy Ileocecal Valve
LOCATING YOUR ILEOCECAL VALVE
This is where your ileocecal valve is found – on the RIGHT side of your body, about 4 fingers (c. 2″) below your navel and 4 fingers to your right side, just inside your pelvic bone:
An image of a malfunctioning ileocecal valve is visible in the thermogram below, on the right of the body, just inside the hip bone.
Thermogram Showing a Blocked Ileocecal Valve
ALCOHOL AND ILEOCECAL MALFUNCTION
Consumption of excessive amounts of alcohol will stress the ileocecal valve, causing it to stick in the open position. This result is one of the main causes of hangovers. (Minckler, undated)
ILEOCECAL VALVE SYNDROME
Click here to see a larger version of this chart if you’re unable to read the small print in the one above.
Problems with the ileocecal valve (sticking in the open or closed position) cause such a variety of symptoms, the valve has been called the “great mimicker” by the chiropractic profession. Its symptoms can manifest far from the valve itself.
Interestingly, symptoms of an open or closed ileocecal valve are very similar. They include (Pollard, undated) (True Vitality, 2015):
Diarrhea or constipation
Heart palpitations and feeling of the heart fluttering
Chest pain during activity
Right shoulder pain simulating bursitis
Whole body arthritis
Sudden, stabbing, sharp low back or leg pain that feels just like a disc pain, especially when sitting or driving, with no mechanical cause
Sharp, pinpoint headaches, especially on the left side, at the base of the skull
Dull headaches, which often linger for hours in the frontal area
Migraine headaches – often as a system-wide response to the toxicity of the ileocecal valve
Chronic sinus infection, dripping sinuses, especially when not during allergy season
Allergies – the type often wrongly attributed to dust, cat hair, and mites
Dark circles under the eyes, puffy cheeks
Any of the “colon syndromes” such as Crohn’s disease, spastic colon, irritable bowel, celiac disease
Burning leg pain (that feels like a nerve) into the front of the left thigh
General non-specific lower GI discomfort or symptoms often attributed to a psychological cause by practitioners unfamiliar with the ileocecal valve
Pollard offers this useful analogy of what happens when your ileocecal valve doesn’t work properly:
“Let’s say you have just finished preparing a wonderful meal and are about to sit down to enjoy it. Just before you do, you place the meal on the counter next to the sink. You take the remnants of the preparation process–carrot tops, meat gristle, pineapple thorns, and whatever else–and put them in the garbage disposal to be whisked away.
“For our example, let’s say you forget to put the cover on the garbage disposal. What happens when you flick the switch? As you might imagine, the contents of the garbage meant for disposal could fly all around the kitchen area mixing with your newly prepared meal. If this happened, you wouldn’t want to eat your meal.
“It goes without saying that you don’t want the contents of the garbage area of your intestines mixing with the contents of the kitchen area. Unfortunately, this is exactly what happens in the body’s most important “kitchen area,” the small intestine.
“The ileocecal valve serves the same function as the cover or cap on the garbage disposal. If the ileocecal valve becomes open and remains open, the contents of the large intestine can and do leak back into the small intestine. This is not good for many reasons.
“One reason is the contents of the two different sections of the tube have different pH chemistry. If the two juices mix, this immediately causes gas. Another is that the contents of the small intestine are to be absorbed; whereas the contents of the large intestine are to be eliminated.
“The whole purpose of the ileocecal valve is to prevent the contents of these two distinctly different parts of the digestive tube from coming in contact. Probably very few people have not had some discomfort from their ileocecal valve at some point in their lives.” (Pollard, undated)
IMPORTANCE OF CHEWING OUR FOOD WELL BEFORE SWALLOWING IT
If we’re swallowing our food before it has been properly chewed, we’re putting great stress on the various parts of our digestive system as they try doing their specific jobs of breaking it down to extract nutrients from it and move it along.
Digestion begins in the mouth with mastication (the chewing process). If we’re not doing it well or long enough, we’re inviting some serious health problems.
Our whole digestive system below the mouth is designed to process increasingly smaller particles passing through its various parts.
Chewing breaks down the large chunks we put in our mouths into smaller particles, making it easier for the digestive juices in our stomachs to turn the masticated food it receives into chyme (partially digested food), our intestines to absorb nutrients and energy, and preventing improperly digested (too large) food particles from getting through the mucosal lining of our small intestine and into our blood stream, where their presence causes autoimmune reactions.
The longer we chew our food, the more opportunity we’re giving the enzyme-containing saliva in our mouths to begin breaking it down. Our saliva also helps lubricate our food, easing its passage down the esophagus on its way to the stomach.
Here are some tips for how to prepare our food before it begins its journey down our gullets, into our stomachs and beyond (Mercola, 2013):
Take smaller bites of food. You won’t have to work as hard to reduce them to smaller particles.
Chew slowly and steadily.
Chew until your mouthful of food is liquefied or has lost its texture.
Chew and swallow completely before taking another bite of food.
Wait to drink fluids until after you’ve swallowed.
It’s especially important to chew these difficult foods carefully and completely so they don’t clog your ileocecal valve: Raw salads, popcorn, and raw nuts. (Pollard, undated)
EMOTIONAL STRESS AND DIGESTION
We’re all aware that physical and emotional stress impact all the systems in our bodies – including our digestion. Our bodies are hard wired to scan the environment for imminent attacks or threats to our existence – very big sources of stress. When our autonomic nervous system (ANS) perceives such a threat, it sets off a series of reactions to maximize our chances of successfully fighting off the threat or running away from it.
These are the body’s automatic Fight or Flight responses:
These responses made a great deal of sense for our survival when we were in frequent danger of being eaten or maimed by wild animals – we either stayed to fight them or ran away. The act of either physically fighting or fleeing resets the entire Fight or Flight system, using up the extra adrenaline our ANS has released to increase our chance of successfully fighting or fleeing. This reset allows the body to return to its natural state of balance (homeostasis).
In our current world, our bodies still automatically put us into Fight or Flight when we feel in danger but the threats to us now are mostly ones not amenable to physical fights or speedy escapes. They’re mostly from the frightened chatter going on in our heads (eg, financial worries, worry about the future, what to do about stresses at home or at work) so our bodies aren’t easily able to reset and return us to homeostasis. (Benn, 2015)
Unresolved vs Resolved Fight or Flight Response
Our digestive systems shut down or greatly slow down when we feel threatened and go into Fight or Flight. The energy required for digestion gets diverted elsewhere where it’s immediately needed for life-saving activities.
Here’s a description of the profound changes that take place in the body whenever our ANS initiates Flight or Flight:
“When our fight or flight response is activated, sequences of nerve cell firing occur and chemicals like adrenaline, noradrenaline and cortisol are released into our bloodstream. These patterns of nerve cell firing and chemical release cause our body to undergo a series of very dramatic changes. Our respiratory rate increases. Blood is shunted away from our digestive tract and directed into our muscles and limbs, which require extra energy and fuel for running and fighting. Our pupils dilate. Our awareness intensifies. Our sight sharpens. Our impulses quicken. Our perception of pain diminishes. Our immune system mobilizes with increased activation. We become prepared—physically and psychologically—for fight or flight. We scan and search our environment, “looking for the enemy.”
“When our fight or flight system is activated, we tend to perceive everything in our environment as a possible threat to our survival. By its very nature, the fight or flight system bypasses our rational mind—where our more well thought out beliefs exist—and moves us into “attack” mode. This state of alert causes us to perceive almost everything in our world as a possible threat to our survival. As such, we tend to see everyone and everything as a possible enemy. Like airport security during a terrorist threat, we are on the look out for every possible danger. We may overreact to the slightest comment. Our fear is exaggerated. Our thinking is distorted. We see everything through the filter of possible danger. We narrow our focus to those things that can harm us. Fear becomes the lens through which we see the world.” (Neimark, undated)
When we remain in a chronic state of Fight or Flight – whether from internal worry or external circumstances, we remain in a highly aroused state of chronic stress. The fact that perceived threat as well as actual threat sets off Fight or Flight is important to understanding why so many of us live locked in a state of Fight or Flight.
Since what’s going on in the mind directly affect the health of the body, chronic stress, trauma and strong emotion we’re unwilling to deal with, and exhaustion take a toll on the body – including our ileocecal valves.
Chiropractor Melinda Benn says this about the emotional aspects of ongoing stress from chronic Fight or Flight:
“The body has a record of every physical and/or emotional trauma that it has ever encountered. These traumas can cause the body to be locked in the fight-flight pattern discussed above. Oftentimes illness occurs because of trauma that is locked into the cells.
The root cause of the health problem must be addressed for the symptoms to resolve. “For example, many lung problems stem from grief. The lungs are the organ of grief and prolonged grieving, even on a subconscious level, can and will often cause chronic lung problems such as bronchitis, continuous colds, or even recurrent pneumonia. These problems often do not respond well to traditional medical care such as antibiotics, because the problem is not rooted in a bacterial or viral infection but is instead rooted in the cell memory of the person’s grief. By discharging the cell memory the body is able to heal itself and continue functioning without the constant health problems that the memories created. This work will not remove a persons memories, only the negative effects the cell memory may be having on the body.” (Benn, 2015)
VIDEOS OF HOW TO DO MANUAL PYLORIC & ILEOCECAL RELEASES
The video below, made by Tammy Kohlschmidt of Thermography For Health, demonstrates how to release both your pyloric and ileocecal valves. Tammy has graciously given permission to include her video here.
Use this password to open and view it: videosetpv
Here’s a second instructional video, made by Thermal Imaging of the Southwest, on how to flush the stomach contents for problems like bloating, constipation and blockage.
This third video, Your Ileo Cecal Valve and how to close it when it’s stuck open, demonstrates how to close the valve manually from a standing position. It explains what the ileocecal valve is, its location, and how to close it yourself it it’s stuck open. The video details the type of sensation you’ll have when the valve is stuck in its open position.
WRITTEN INSTRUCTIONS FOR MANUAL PYLORIC & ILEOCECAL VALVE RELEASES
To help me remember how to do these manual valve releases, I wrote out the steps from Tammy Kohlschmidt’s video:
PYLORIC & ILEOCECAL VALVE RELEASES
Lie down flat with a half roll (or small rolled up blanket) under your lumbar area so your abdomen is raised a bit. You may also want to put a small pillow or yoga block under your head.
Have a 3 pound or larger hand weight nearby. You can use a glass bottle filled with liquid if you don’t have a hand weight. The weight is easier to hold and works better at getting into the valves.
PYLORIC VALVE RELEASE (do for 1-2 minutes)
Your pyloric valve connects your stomach to your small intestine. It’s located about 4 fingers (c. 2″) up from your navel, more or less in the center of your body.
Use the end of the hand weight to knead on top of your pyloric valve, rocking from its L side (the stomach end of the valve) toward its R side (where the pyloric valve connects to the small intestine).
Then use the end of the weight to push all the way from your L (on the stomach) to the pyloric valve to move any partially digested food in your stomach through your valve into your small intestine.
Repeat several times.
ILEOCECAL VALVE RELEASE (do for 1-2 minutes)
Your ileocecal valve connects your small intestine to your large intestine. It’s located about 4 fingers down from your navel (c. 2″) + 4 fingers to your R. This valve opens diagonally toward your L shoulder.
Use the end of a 3 pound weight to push into the valve, up and diagonally in the direction of your L shoulder.
Use the end of the weight to push all the way from the L side of your body on a horizontal line, along the small intestine, all the way over to your ileocecal valve on your R.
FOOT REFLEXOLOGY FOR THE ILEOCECAL VALVE
Reflexology is a therapeutic massage technique employing the application of specific types of pressure of hand, thumb and fingers to points on the extremities corresponding to a map of the human body’s reflex points.
This diagram shows where the reflexology point for the ileocecal valve is located – near the little toe side edge of the RIGHT foot, just above the heel:
Here’s a photo of reflexology pressure being applied to the ileocecal point on the sole of a person’s right foot:
ILEOCECAL VALVE REFLEXOLOGY POINT
If you’ve ever had foot reflexology, you know that spots corresponding to organs and other parts of your body where you’re having difficulties may be tender and pressure applied to them can hurt – a bit or a lot.
The helpful aspect of this is that, you know when you’ve found the right spot when you’re doing reflexology on yourself.
My ileocecal valve has been malfunctioning so I decided to do some reflexology on myself. When I applied firm pressure on the ileocecal point, it felt quite tender – and the tenderness continued for a few minutes after I stopped. Just for comparison, I applied equal pressure on the same spot on my left sole. That felt good but not at all tender.
For people who doubt its efficacy, here’s the story of my first encounter with foot reflexology:
While on vacation with my family in Colorado, I had stomach flu or some other kind of digestive problem that caused great distress whenever I tried eating anything. I’d heard of reflexology and saw that the spa at our hotel offered it. It turned out their reflexologist was out of town that day but another experienced masseur, who could see how ill I felt, said he had a reflexology chart and would try if I was willing.
As he worked on my feet, most of the points he touched felt good – until he got to the digestive areas. (At that time, I had no idea where the various reflex points were located.) When he pressed there, they hurt so much tears came to my eyes. He said he knew those spots would be tender and was purposely using only a very light touch there, which he demonstrated on my arm, where I could barely feel it. So I let him continue, doing Lamaze breathing for the pain, eyes streaming the whole time.
When he was done, I found I was too weak to stand without assistance. So he helped me to a couch in the waiting room, gave me a cup of hot ginger tea, and let me sleep there until I woke up about an hour later – and discovered my digestive problem was totally gone!
I’ve been a big fan of foot reflexology ever since.
If you’re doing foot reflexology on yourself, a Thai Foot Massage Stick is useful. It lets you apply more pressure directly on a point than your fingers probably will.
DONNA EDEN’S METHOD FOR NORMALIZING THE ILEOCECAL VALVE
The wonderful Donna Eden, author of several books on Energy Medicine, has another method for returning the ileocecal valve to its normal rhythm. I highly recommend watching this short video showing her teaching it at a workshop. Donna may be the most joyful person on the planet and is an excellent teacher.
WHAT I DO NOW TO RELEASE MY PYLORIC AND ILEOCECAL VALVES
When the severe bloating began, I consulted Dr David Miller, who explained that food was fermenting in my GI tract instead of digesting, causing the bloating. That made sense to me but I didn’t know how to stop the fermenting yet. I tried a variety of digestive enzymes that helped some but the problem continued.
I’m concentrating now on chewing my food thoroughly before swallowing, practicing ways to keep my gut from clenching – or relaxing it when I notice it has already clenched, and figuring out when and how often I need to do the release exercises.
Sometimes I use a 3 pound weight to release those valves as shown in the videos.
I also sometimes lie face down on a 4″ hollow, squishy, spiky ball and use the weight of my body instead of pushing with the weight. First, I place the ball under my pyloric valve and move my body on it from left to right to release the valve. Then I move the ball to under my ileocecal valve and roll that part of my body over it in a valve-toward-left shoulder direction to release the valve.
Here’s a picture of the ball I use, somewhat on the under-inflated side so it gives a bit as I lie on it:
They’re called EduShape Sensory Balls, available from Amazon. The 4″ balls are the ones at the top in the box:
If I’m out and about and can’t do the more thorough releases with either the weight or squishy ball, I use my hands:
I make a fist of my right hand and press into my pyloric valve with the knuckles, rocking them from left to right until I feel the valve release.
Using my right hand in a fist, I press the knuckles into my ileocecal valve and rock upward on a diagonal toward my left shoulder until I feel the valve release.
I’m also going to start using Donna Eden’s method and/or reflexology on the ileocecal valve point – especially when I’m traveling.
Ever feel like this?
My profound thanks to Tammy Kohlschmidt of Thermography for Health for identifying my pyloric and ileocecal valve problems via thermography and then setting me on the path to knowing how to fix them.
Peter Rost, MD, worked in medical advertising before moving into the pharmaceutical and biotech industry in 1992. Among the positions he has held are Vice President for Marketing in the Women’s Healthcare Division at Wyeth Pharmaceuticals, Vice President for Marketing and Endocrine Care at the Swedish pharmaceutical and biotechnological company Pharmacia, and Vice President for Marketing at multinational pharmaceutical giant Pfizer.
Rost turned whistleblower on the entire pharmaceutical industry after becoming concerned about unethical, illegal, and even criminal practices he’d observed at Wyeth and Pfizer .
Published in 2006, The Whistleblower: Confessions of a Healthcare Hitman is his insider’s exposé of the pharmaceutical industry.
Amazon’s description of the book:
A number of books critical of the pharmaceutical industry have recently been published, but none has been an exposé written by a senior executive of one of the world’s largest pharmaceutical companies. The Whistleblower is at once an unmasking of how corporations take care of malcontents and a gripping story of one man’s fight to maintain his family and his sanity. Starting in 2003, the book details the illegal, even criminal business practices the author witnessed at his corporation, as well as his crusade to legalize the reimportation of drugs. It also explains how in this post-Enron world whistle-blowers can’t simply be fired, and what the author’s corporation did to coerce and silence him. A story of a battle that continues today, one which any American who takes or will take prescription drugs has a stake in, The Whistleblower is a powerful testimony.
Below is a short video of Rost speaking about the close ties between the pharmaceutical industry and the medical profession. The clip is from a documentary called ONE MORE GIRL, about Gardasil, a vaccine developed by Merck to prevent the sexually transmitted Human Human Papillomavirus (HPV). The tag for Gardasil ads is variations on “I want to be one less girl who battles cervical cancer.”
Since Gardasil was introduced, thousands of girls have had adverse reactions to it and it has killed over 100 girls. Reactions to the vaccine have included strokes, seizures, dizziness, fatigue, weakness, headaches, stomach pains, muscle pain and weakness, joint pain, auto-immune problems, chest pains, hair loss, appetite loss, personality changes, insomnia, hand and leg tremors, arm and leg weakness, shortness of breath, heart problems, paralysis, itching, rashes, swelling, aching muscles, menstrual cycle changes, fainting, swollen lymph nodes, night sweats, nausea, temporary vision/hearing loss. (The Truth About Gardasil, undated)
The US FDA approved use of the vaccine in 2006, recommending vaccination before adolescence. Gardasil is now being recommended for boys as well as girls.
One of Gardasil’s lead researcher developers, HPV expert, and Merck insider, Dr Diane Harper, notes that the vaccine has not been shown to prevent cervical cancer. “95% of women who are infected with HPV never even get cervical cancer. It seemed odd to be mandating something which 95% of infections never amount to anything. Pap smear screening is far and away the biggest thing a woman can do to protect herself to prevent cervical cancer.”
Dr Harper also points out that Merck’s marketing campaign was designed to scare parents into getting their children vaccinated. “If parents and girls were told the benefits and harms of Pap screening and HPV vaccines, an informed and valued decision would have been able to be made.” (Landis, 2013)
The CDC recommends a three-dose series of HPV vaccination for all 11 or 12 year old children. At least 25 states and territories have already enacted legislation making HPV vaccinations mandatory for girls entering 6th or 7th grade. (National Conference of State Legislatures, 2015)
Here are some of Big Pharma’s unsavory practices – draw your own conclusions:
21 TOP BIG PHARMA COMPANIES
PROFITS OVER DRUG EFFECTIVENESS & SAFETY
Here’s but one example of a much broader problem: childhood vaccines.
Robert F. Kennedy, Jr., recent article, Children at Risk – Vaccines, Government & Big Pharma’s Dirty Money, reveals that, as of 2013, the Centers for Disease Control and Prevention (CDC) had 271 new vaccinesunder development. If approved, this would bring $100 billion in vaccine revenues into the coffers of pharmaceutical companies by 2025.
As it is, the CDC’s recommended vaccination schedule calls for 49 doses of 14 different vaccines between birth and age 6. Most babies in the US receive over 24 vaccines by their first birthdays and most children here get a minimum of 56 doses of 14 vaccinations by age 18. This in spite of the CDC’s acknowledging that vaccines can have dangerous side effects and are sometimes fatal. (England, 2015)
A 2011 study found that developed nations, like the US, which administer the largest number of vaccinations in the first 12 months of life, have the highest infant mortality rates. (Mercola, 2011)
Kennedy wrote of the CDC (England, 2015):
“Public health may not be the sole driver of CDC decisions to mandate new vaccines. Four scathing federal studies, including two by Congress, one by the U.S. Senate, and one by the HHS Inspector General, paint CDC as a cesspool of corruption, mismanagement and dysfunction with alarming conflicts of interest suborning its research, regulatory and policymaking functions. CDC rules allow vaccine industry profiteers like Dr. Offit to serve on advisory boards that add new vaccines to the schedule. In a typical example, Offit in 1999 sat on the CDC’s vaccine advisory committee and voted to add the rotavirus vaccine to CDC’s schedule, paving the way for him to make a fortune on his own rotavirus vaccine. Offit and his business partners sold the royalties to his rotavirus vaccine patent to Merck in 2006 for $182 million. Offit told Newsweek, ‘It was like winning the lottery!’”
This is the CDC’s recommended vaccination schedule for children from birth to 18 years:
BIRTH (12 hours)
12 – 18 MONTHS
2 – 6 YEARS
MULTIPLE VACCINATIONS GIVEN SIMULTANEOUSLY
“In 1983, the CDC directed doctors to give a child no more than 4 vaccines (DPT, polio) simultaneously. By 2013, the CDC directed that a child can receive 8 or more vaccines at once.
“The Institute of Medicine published a report in 2013 stating that ‘key elements of the entire [child vaccine] schedule – the number, frequency, timing, order and age of administration of vaccines – have not been systematically examined in re- search studies.’”
VACCINATIONS DURING PREGNANCY
“A new CDC policy directs doctors to give pregnant women one dose of influenza vaccine in any trimester and one dose of pertussis containing Tdap vaccine after 20 weeks during every pregnancy. The U.S. Food and Drug Administration (FDA) has determined that there are no adequate, well controlled studies conducted in pregnant women to determine if it is safe for the developing fetus or pregnant woman to receive Tdap and Influenza vaccines during pregnancy.”
Source: National Vaccine Information Center, 2013
And the CDC is considering adding even more vaccines to this list – possibly as many as 271?
HOW BIG PHARMA INFLUENCES DOCTORS
Recently mandated data collected by the US Department of Health and Human Services shed light on the cozy relationship between doctors and the health care industry. Pharmaceutical and medical device companies made 4.4 million payments to 500,000 health care professionals and teaching hospitals — adding up to a total of almost $3.5 billion.
The table below breaks down the amounts:
Pharmaceutical and medical device companies made payments of $3.48 billion to doctors and other health care professionals in the five-month period from 8/1-12/31/2013. (Thomas et al, 2014)
Research payments $1.49 billion
Ownership interest 1.02 billion
Speaking and consulting fees 380 million
Royalties and licenses 302 million
Travel, food, lodging 167 million
Other 128 million TOTAL $3.48 billion
Source: U.S. Department of Health & Human Services
“Big Pharma spends almost $20 billion annually marketing their products to doctors, which yields profits upwards of $300 billion per year in drug sales. A handful of these doctors were paid more than $500,000 apiece. Others were paid millions for the drugs and devices they helped to create. Doctors insist that this money doesn’t influence what they recommend to their patients. However, it’s extremely difficult to imagine what purpose the payments would serve if not to increase product sales through prescriptions.” (Byrd, 2014)
Dr. Michael Carome, Director of Public Citizen’s Health Research Group, commented: “When you look at why do drug companies and device companies make gifts and offer consulting payments and honoraria to physicians, the main goal is to influence prescribing practices. The interest of those companies is to improve their financial bottom line, and not necessarily represent the best interest of patients.” (Thomas et al, 2014)
PHARMA SPENDS MORE ON MARKETING THAN ON RESEARCH & DEVELOPMENT
The World Health Organization (WHO) states:
“The global pharmaceuticals market is worth US$300 billion a year, a figure expected to rise to US$400 billion within three years. The 10 largest drugs companies control over one-third of this market, several with sales of more than US$10 billion a year and profit margins of about 30%. Six are based in the United States and four in Europe. It is predicted that North and South America, Europe and Japan will continue to account for a full 85% of the global pharmaceuticals market well into the 21st century. Companies currently spend one-third of all sales revenue on marketing their products – roughly twice what they spend on research and development.
“As a result of this pressure to maintain sales, there is now … an inherent conflict of interest between the legitimate business goals of manufacturers and the social, medical and economic needs of providers and the public to select and use drugs in the most rational way. This is particularly true where drugs companies are the main source of information as to which products are most effective.” (WHO, 2015)
BIG PHARMA PAYS SCIENTISTS FOR GHOSTWRITTEN PAPERS
It’s well known that drug companies have a practice of paying large sums of money to physicians at elite medical centers and other experts in their fields to allow themselves to be listed as the “authors” of articles endorsing new drugs – articles actually written by ghostwriters (people employed by the companies manufacturing the drugs) and which the “authors” had no hand in either researching or writing.
For a ghostwritten article, the actual author is not named in the final published manuscript, only the well-known recruited physician or expert who has had limited or zero involvement with any aspect of the research – from clinical trial, study design, methods, data collection and analysis, or writing of the manuscript. The named author may have been allowed to look at tables compiled by the company employee but has probably not ever seen the study’s raw data.
“Ghostwriting is part of a larger scheme called ‘publication planning,’ a process by which pharmaceutical, biotechnology, medical device, and medical supply companies produce, publish, and release articles in medical journals, abstracts and posters at conferences, meetings, and symposia, to establish key marketing messages. This process is closely monitored to ensure that the sponsoring companies’ medications are being effectively promoted. This process has been known to disseminate information embedded with factual errors, misrepresentation, overstated benefits, and understated risks of medications being promoted.” (Shnier, 2014)
Dr David Healy, a British psychopharmacologist, said in 2002, “It may well be that 50% of the articles on drugs in the major journals across all areas of medicine are not written in a way that the average person in the street expects them to be authored.” (Boseley, 2002) The practice has only increased since then.
Ghostwriting has become especially widespread in medical fields where drugs play a major role in treatment, such as cardiology and psychiatry.
Senator Charles Grassley (R-Iowa), who has been leading a long-running investigation into conflicts of interest in medicine, put pressure on the National Institutes of Health to stop the practice of ghostwriting.
In response to Grasley’s exposure of cases where leading medical researchers neglected to report monies received from pharmaceutical and medical device companies, in 2010 the NIH proposed improved disclosure guidelines for federal grant recipients. (Grassley, 2010)
A “Sunshine Act” was enacted into law by Congress in 2010 and implemented in 2013 as part of the Patient Protection and Affordable Care Act, familiarly referred to as Obamacare. Under the PPACA, pharmaceutical, medical device, and medical supply manufacturers must report payments and exchanges of value each year. Those companies have questioned exactly which “exchanges of value” require disclosure. (Shnier, 2014)
One of the contested areas is whether companies are required to disclose “medical writing support provided by pharmaceutical companies to authors of clinical studies” and “editorial services.”
BIG PHARMA’S INFLUENCE ON MAJOR MEDICAL JOURNALS
Dr Ben Goldacre, an epidemiologist and author of Bad Science: Quacks, Hacks, and Big Pharma Flacks (2010) and Big Pharma: How Drug Companies Mislead Doctors and Harm Patients (2014), discovered that drug companies funnel $10 – 20 million annually to major medical journals such as the New England Journal of Medicine and the Journal of the American Medical Association. He notes it’s therefore not surprising that studies funded by the pharmaceutical industry are more likely to make it into print in these influential journals. (Goldacre, 2014).
FDA IN BED TOGETHER WITH BIG PHARMA
Medical and Organizational Sociologist Donald W. Light’s 2013 paper, entitled “Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs”, presented damning evidence against the US Food and Drug Administration for failing to scrutinize the safety and efficacy of new drugs adequately before allowing them to be marketed.
After compiling his data and noting that almost all the new drugs the agency approved over the previous 30 years were little or no better than drugs already on the market, Light concluded the FDA “cannot be trusted”, that the agency has become a pay-for-play front group catering to the interests of the pharmaceutical industry. FDA approval of old drugs repackaged with only minor changes allows companies to renew their patents and reap new record-profits. Patents typically last 20 years from the date of filing.
Drug companies provide the major source of the FDA’s funding so the agency has succumbed to pressure to speed up the approval process for bringing new drugs to market – putting patients at increased risk.
Light’s report points out that prescription drugs, used as directed, kill at least 125,000 people annually yearly, making them the fourth leading cause of death in the US. Tens of thousands more are hospitalized each year from adverse effects from prescription drugs.
“[O]ver the past 30 years, approved drugs have caused an epidemic of harmful side effects, even when properly prescribed,” explains a preface to the Harvard report. “Every week, about 53,000 excess hospitalizations and about 2,400 excess deaths occur in the United States among people taking properly prescribed drugs to be healthier.”
“The FDA in effect serves as the re-generator of patent-protected high prices for minor drugs in each disease group, as their therapeutic equivalents lose patent protection,” explains the report. “The FDA routinely approves scores of new minor variations each year, with minimal evidence about risks of harm. … One in every five drugs approved ends up causing serious harm.”
Light’s paper was published in a special issue of the Journal of Law, Medicine & Ethics. (Huff, 2013)
MEDICAL FIELD IN BED WITH PHARMA – MORE EVIDENCE
Dr Marcie Angell is currently Senior Lecturer in Social Medicine at Harvard Medical School and was the Editor-in-Chief of the New England Journal of Medicine for two decades. Her January 15 2009 New York Review of Books article, “Drug Companies & Doctors: A Story of Corruption”, is worth looking at. It discusses three books on the corrupt doings of Big Pharma, their adverse effects on the practice of medicine and our health:
Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial by Alison Bass. This is the story of how British drug giant GlaxoSmithKline buried evidence that Paxil, its best-selling antidepressant, was ineffective and possibly harmful to children and teens.
Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs, by Melody Petersen. This book and and the one below are about drug companies’ highly effective tactic of creating newly identified conditions with serious-sounding quasi-medical names that seem to require long-term treatment with their drugs. As examples: we’re being bombarded by ads for drugs to help us with Gastro-esophageal reflux disease, Social Anxiety Disorder, Premenstrual Dysphoric Disorder, Erectile dysfunction. “Ask your doctor.”
Shyness: How Normal Behavior Became a Sickness
by Christopher Lane
These three books cover such unsettling topics as the financial ties between Big Pharma and the academic physicians who play a large role in setting the market value of prescriptions drugs, sloppy research, unapproved and dangerous off-label use of pharmaceutical, huge speaking and consulting fees pharmaceutical companies pay to some physicians who routinely prescribe their drugs, the serious conflict of interest practice of allowing drug companies to pay researchers to test their products. There’s more – all of it involving huge sums of money and quite unsavory
Dr Angell concludes her review:
“After much unfavorable publicity, medical schools and professional organizations are beginning to talk about controlling conflicts of interest, but so far the response has been tepid. They consistently refer to “potential” conflicts of interest, as though that were different from the real thing, and about disclosing and “managing” them, not about prohibiting them. In short, there seems to be a desire to eliminate the smell of corruption, while keeping the money. Breaking the dependence of the medical profession on the pharmaceutical industry will take more than appointing committees and other gestures. It will take a sharp break from an extremely lucrative pattern of behavior. But if the medical profession does not put an end to this corruption voluntarily, it will lose the confidence of the public, and the government (not just Senator Grassley) will step in and impose regulation. No one in medicine wants that.”
“MOST PUBLISHED RESEARCH FINDINGS ARE FALSE”
As if the revelations about Big Pharma aren’t bad enough, it also appears that much of the medical research that gets published and forms the basis of medical practice is seriously flawed.
John Ioannidis MD is currently Professor of Health Research and Policy at Stanford School of Medicine, the University’s Rehnborg Chair in Disease Prevention and Director of its Prevention Research Center, as well as Co-Director of the Meta-Research Innovation Center at Stanford.
Ioannidis and other experts point out there is considerable evidence showing severe flaws in the science underlying medical education and pharmaceutical development.
Ioannidis is one of the world’s most respected experts on the credibility of medical research. He and his team have found problems in the science behind as much as 90% of the published medical information doctors rely on when prescribing medications, recommending tests and surgical procedures, and advising patients on dietary practices. (Freedman, 2010)
In the early 1990’s Ioannidis, was starting out as a physician and researcher at Harvard. He was also a math whiz and decided to apply rigorous statistical analytic procedures to the research data he presumed backed up doctors’ treatment decisions. “I assumed that everything we physicians did was basically right, but now I was going to help verify it,” he says. “All we’d have to do was systematically review the evidence, trust what it told us, and then everything would be perfect.”
What he discovered shocked him: There was a great deal of published research but much of it was quite sloppily done. Many of the studies were based on observations of only a small number of cases. He also noted that many research findings in all areas of medical research were refuted by later studies. Hardly compelling scientific evidence to underpin the practice of medicine.
“I realized even our gold-standard research had a lot of problems,” he says. So he began looking for the specific ways in which studies were going wrong and discovered an astonishing range of errors: Problems in the ways researchers posed their research questions, skewed selection of study participants, use of seriously flawed research designs and measurements of their test variables, faulty analyses of their data, poor presentation of the results, problems with how studies were chosen for or denied publication in medical journals.
Ioannidis realized a serious dysfunction underlay these flaws. “The studies were biased,” he says. “Sometimes they were overtly biased. Sometimes it was difficult to see the bias, but it was there.” We tend to think scientific research is an objective and rigorous process but that’s often not the case. Researchers undertake studies hoping to find particular results – they want their hypotheses to be shown to be true. And it’s easy to manipulate results, intentionally or unconsciously. “At every step in the process, there is room to distort results, a way to make a stronger claim or to select what is going to be concluded,” says Ioannidis. “There is an intellectual conflict of interest that pressures researchers to find whatever it is that is most likely to get them funded.” (Freedman, 2010)
By the late 1990’s, he and his team began publishing a series of papers pointing out the specific ways medical researchers were obtaining misleading results. By this time, he was no longer the only meta-researcher calling attention to the high rate of errors in medical literature. But he was determined to present his findings in a way that would demonstrate the seriousness of the problem.
In 2005 Ioannidis published his findings as “Why Most Published Research Findings Are False”. This article became the most widely accessed article in the history of the online medical journal PLoS (the Public Library of Science).
In the PLoS paper, Ioannidis presented a detailed mathematical proof that researchers will arrive at incorrect findings most of the time. Factors going into this calculation were: Researcher bias, flawed research techniques, the tendency to study career-advancing topics rather than use good science to test more plausible hypotheses, and using the peer-review process to bar opposing views from getting published. (Freedman, 2010) (Ioannidis, 2005-B)
From Ioannidis’s summary of his PLoS paper:
“There is increasing concern that most current published research findings are false. … Simulations show that for most study designs and settings, it is more likely for a research claim to be false than true. Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias.”
Take a look at the PLoS article if you want to see how he reached the conclusion that “most published research findings are false”.
Professor Doug Altman, a UK researcher and Director of the Oxford Centre for Statistics in Medicine, says of Ioannidis’ conclusions, “You can question some of the details of John’s calculations, but it’s hard to argue that the essential ideas aren’t absolutely correct.” (Freedman, 2010)
Ioannidis published a second paper, called “Contradicted and Initially Stronger Effects in Highly Cited Clinical Research”, that same year in the Journal of the American Medical Association. This one is a meta-analysis of original clinical research studies on medical intervention effectiveness published in the three major general clinical journals (New England Journal of Medicine, JAMA, Lancet) and in the 17 highest-impact specialty journals between 1990-2003. Articles had to have been cited over 1,000 times in the medical literature to be included in the analysis. (Ioannidis, 2005 -A)
For this paper, Ioannidis and his team compared the results of these highly-cited articles against studies of about the same or larger sample size and similar or better-controlled designs. They also performed the same comparative analysis for matched studies that had been less frequently cited to see if the findings and potential for contradiction of highly-cited studies differed from less frequently studies.
Their meta-analysis included these findings:
45 of 49 highly-cited original studies claimed their interventions were effective. Of these 45, the results of 16% of them were contradicted by later studies. Subsequent studies found weaker effects than had been reported in 16% of the original studies. 44% of the studies were later replicated. 24% of them were unchallenged.
84% of the published results in the highly-cited, non-randomized, original studies were later either contradicted or weaker effects were subsequently found.
Matched control studies had about the same share of refuted results as highly-cited studies but included more studies with ‘negative’ results. (* See NOTE on ‘negative findings below.)
Ioannidis points out that “most research publications have little impact while a small minority receives most attention and dominates scientific thinking and clinical practice…. Clinical research on important questions about the efficacy of medical interventions is sometimes followed by subsequent studies that either reach opposite conclusions or suggest that the original claims were too strong. Such disagreements may upset clinical practice and acquire publicity in both scientific circles and in the lay press.” (Ioannidis, 2005-A)
Ioannidis’ two 2005 papers challenge the very foundation of conventional medical research and practice. His writings have been published in leading medical journals and are heavily cited.
Years ago, when I was reviewing published research on psychosocial aspects of breast cancer for the Stanford Research Institute, my own observations coincided with those Ioannidis discovered. Sometimes the stated research hypothesis being tested was so vague, any results would be meaningless. It was often impossible to tell the basis on which subjects had been selected to be in the research and control groups. Sometimes there wasn’t even a control group. Results were sometimes presented without any description of how they’d been analyzed. The probability level chosen for analyzing the data was often not stated so there was no way to tell if the findings were in any way statistically meaningful.
THE VIEWS OF TWO PROMINENT MEDICAL JOURNAL EDITORS
The observations below, from a former and a current Editor-in Chief of two of the world’s best regarded medical journals, lend strong support to Rost and Ioannidis’ claims:
“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of the New England Journal of Medicine.” – Dr Marcia Angell, physician and longtime Editor-in-Chief of the New England Medical Journal (Marcovitch, 2010)
“The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness.” – Dr Richard Horton, the current Editor-in-Chief of the Lancet (Walia, 2015)
A NOTE ON ‘NEGATIVE’ FINDINGS
The Null Hypothesis
The Null Hypothesis states there is no significant relation or difference between two variables so no good reason for changing our thinking about how they relate to each other. In scientific study, researchers are trying to REJECT the Null Hypothesis by demonstrating grounds for believing their Alternative Hypothesis has merit – that a significant relationship DOES EXIST between the phenomena or groups they’ve studied – (eg, that treatment with a potential drug has a measurable effect).
If the research results don’t reject the Null Hypothesis, then nothing new or surprising has been discovered.
Studies that fail to find positive results are harder to publish. For instance, you set out to show that a particular drug lowers blood pressure and don’t find evidence that it does. Not very sexy – or publishable in a major journal.
The authors of an article entitled “Negativity towards negative results: a discussion of the disconnect between scientific worth and scientific culture” asked the question “What happens when you obtain results that support the null hypothesis, or do not fit with current scientific thinking?”
The authors went on to discuss publication bias and the difficulty researchers encounter in communicating negative results. “Negative findings are a valuable component of the scientific literature because they force us to critically evaluate and validate our current thinking, and fundamentally move us towards unabridged science.” (Matosin et al, 2014)
While all the above is deeply disturbing, it’s also important to remember that some excellent research has been and is currently being done, that pharmaceutical companies also manufacture drugs that have saved many lives and improved the quality of life for many more around the world, and that most physicians are good people with their patients’ best interests at heart.