The Paleolithic diet presumes that foods eaten during the stone-age (Paleolithic era from 2.5 million years ago to 10 thousand years ago) are optimal foods for humans. The Paleolithic (Paleo) diet includes grass fed beef and other lean meats, fish, shellfish, fruits, vegetables,  eggs, nuts, but no grains, no dairy, no salt, no refined fats (butter or margarine) and no sugar or high fructose corn syrup.

Fanatical Diet (Lifestyle types)
There are three things one should never discuss in polite company, religion, politics, and diet. Getting into an argument with proponents of diets is like a democrat trying to convince a republican that Obama is ok. Each side will quote their own studies, statistics, and population studies. But the key to scientific study of the various diets is not what we presume from correlation, but from what we learn when that diet is placed into patients – in this case, the laboratory values of those who have the diet.

Diet proponents become fanatical about their diet (lifestyle) to the point of religious fervor. Seeking to prove that their diet is backed by science, proponents use population studies with associations that are only suggestive and not proof of causation. These associations become propaganda as the associations are repeated over and over, morphing from a suggestion to “proof.”

The Flaws of population studies or Correlation does not equal causation
The foundation of many diets are based on the correlation of what a population eats and what diseases they suffer from. In the Paleo diet the assumption about what they ate and the diseases they suffered from is a spurious correlation at best, and far from causation.

Population studies are flawed, as often we find that we don’t know as much about the population as the data might suggest. Take the Pima Indians of the Southwest. In 1990 a paper came out stating that the Pima Indians had a low incidence of fatal coronary heart attacks in spite of having a high rate of diabetes. The Pima Indians were called among the most studied populations, with an NIH post in Phoenix, and lots of studies showing the highest rate of diabetes in the world. When the population was examined more carefully, the Pima Indians had plenty of heart disease.

Step back from the most studied group in the United States with great statistics and physicians trained in modern medicine and then imagine making conclusions about what Chinese eat, or Mediterranean’s, or French. Those assumptions are more flawed, as are the statements about what diseases they do or do not have. Now step back further trying to determine what people of the Stone Age ate, what diseases they had, and we leave the tenuous role of suggestion and enter the role of outright guessing. Even if we have reasonable data (and often we don’t – even for the best studied people in the United States) the correlation between what people eat as a cause for what diseases they have is a fundamental flaw. Correlation does not equal causation.

The Best Diet or Lifestyle is?
When it comes to the best diet plan for a person – we just don’t know enough to say that one is better than another. There isn’t enough evidence to state that the Paleolithic (also called Paleo) diet is better than the Ornish, Southbeach, Pritiken, or pick one, or better than how you currently live your life.

We cannot broadly say that any given diet will prevent heart disease, cancer, arthritis, or even obesity. When someone tells you a diet can prevent such, they have gone from the realm of science to the realm of bs.

The Paleo Diet Premise:
The Paleo diet premise is that we should avoid certain foods because our body is not evolved to process those foods, and if it does process them it will lead to the chronic diseases of modern man – heart disease, strokes, cancer. Cavemen didn’t have those diseases, so we should eat like cave men. Of course, we don’t know about what diseases that cavemen had – especially when it comes to organ and soft tissue diseases, we just have a few fossils that we examine and look for evidence of known diseases. Would coronary artery disease show up in a fossil – nope? Would cancer show up in the fossil – bone cancer would (kind of a rare cancer) or cancer that went to the bone might – but it would be hard to tell if the fossil evidence.

We do know, from many hunter-gathering societies, that they live a short life, and not long enough to develop the diseases we associate with aging. All a person has to do to pass on their genes is make it into puberty, and to be effective to nurture the young, into the 30′s, and to see grandchildren and help child raising – into the early 40′s. That is what a simple civilization needs. After that, in any primitive society, the elderly become a burden – perhaps to be placed on an ice flow. People who live into their 40′s and 50′s may die of cancer, heart disease, or obesity- but they will have passed on their genetic code.

The Evolution of Homo Sapiens:
When Homo Erectus came out of Africa, they encountered a world that was much more varied in food sources than Africa. The brain of the human (H. sapiens) evolved, becoming much larger, and utilizing far more energy than the brains of the Australopithecus – about 10 percent more. More than any other species, humans evolved a brain that required more calories- and our brain metabolism accounts for up to 25% of our energy needs. Bigger brains and its increased requirements mean a richer diet- and modern hunter gathering species derive about half of the energy from animal foods – in contrast with other primates that have far fewer animal foods. While our ancestors the Australopithecus dined on plant foods, and had large mouths to grind up fibrous plants – humans are built, with smaller faces and jaws, to dine on energy rich animal foods.

The reconstructed skull of Lucy, Australopithecus- large jar and muscles for eating plants

The Human skull is larger, larger brain- and jaws for more energy rich foods

Humans were successful, as the fossil record shows, because they were “flexible” eaters, using a wide variety of dietary strategies. If there were a lot of Elk, then we ate elk- berries, we picked berries. To state that our digestive system evolved only to eat some few items found in the Stone Age – has been disproven on the face of it. Our ancestors in Africa didn’t encounter Arctic char, whales, seals, salmon – and yet when they moved from that warm climate to the frozen north, they adapted quite well to a very high fat diet of primarily animal based diet that was clearly not available in Africa. The findings of starch grains from wild plants in grinding tools from sites in Italy, Russia, and the Czech Republic from the mid-upper Paleolithic era suggest that the production of flour was present 30,000 years ago.

Contrary to what Paleo proponents state: people made flour 30,000 years ago

How to eat like a caveman
There are some things about the Paleo diet that people avoid:

Excess sugars including fructose
Excess Omega 6 oils – including soy
Processed wheat, grains, and gluten
Dairy

What is the scientific evidence for this? It’s the simple premise that modern man has lifestyle illness from altering food, taking in too many calories, and if we would return to our ancestors roots (pun intended) we would avoid these highly processed foods and not suffer from the holy trinity of diabetes, obesity, heart disease, and maybe even cancer. There is not a single shred of evidence to support the premise of this diet.

An entire dietary regimen has been formed with plenty of books and websites to guide you through this. It has become so popular that the question becomes not the flawed premise for the diet, but rather how the diet would compare to other diets. If you want to eat like a caveman, then shop on the outside of your grocery store.  Everything on the inside of your grocery store is generally processed foods, and everything on the periphery of the grocery store is generally not processed.  On the periphery you will find the vegetables, fruits, meat counter, fish counter – although you might get in trouble with dairy, and before you check out they might have a cookie or two – or there might be a bakery (a big no no among the non-Geico types). But lets be clear- whatever the caveman could get that they could eat- they would eat, and if a caveman were to be around today- wait, we have them – well, they eat Poptarts.

In one real scientific study patients with known heart disease who were randomized to either the Mediterranean-like diet (based on whole grains, low fat dairy products, fish, fruit, and vegetables) or the Paleolithic diet (no grains or dairy but plenty of lean meat, fish, fruits, vegetables, root vegetables, eggs, and nuts) and those who undertook the Paleolithic diet were satisfied with less food. There was also a decrease in leptin in the Paleolithic group by 31% and by 18% in the Mediterranean group.

There have been other studies that show that people who go with this diet have improved laboratory values – less triglycerides, lower blood pressure, some weight loss, that the diet has a better glycemic index (the food doesn’t increase blood glucose levels as much). This diet compared to a standard diabetic diet did better. Those studies are short term, with small numbers of individuals, and hints of laboratory values.

So before one assumes I am putting this diet plan into the trash bit along with Ornish- there is clearly some data here that shows good nutritional sense in the food.

While highly processed carbohydrates transiently increases blood glucose levels more than whole grains – it does not mean that bread is bad for a person. At least we don’t know enough about this to state that today. Clearly, people who eat a lot of flour based products can get fat quickly, and getting off the bread and bakery products will help reduce weight, decrease hemoglobin A1C levels, decrease triglycerides, and overall be healthy.  Some people need to be told to never eat them again – as some alcoholics must never drink again- and some people are able to moderate them so they do minimal damage to the body.

Only a few studies have examined the effects of the Paleolithic diet on laboratory values that we associate as increased risk for disease – but again, those were laboratory values, not a long-term follow up for disease.

The premise for the Paleo diet may be flawed, but here are the parts of the Paleo diet that most would agree with:

(a) Highly processed grains – white flour, rolled oats- do cause a rapid increase in blood glucose levels and the body responds to that by increasing triglycerides and ultimately fat.
(b) Fish – as long as it is not contaminated with mercury, is a protein source that is high in Omega 3 fatty acids, which have been shown to be beneficial. If you have some great fish three or four meals a week it works out well.
(c) Vegetables and fruits are the basis for most diets- thus a vegetarian could participate in a Paleo diet easily. Too many people do not eat enough fruits or vegetables or look to them as snacks.
(d) The trend away from cattle feedlots and desire to have grass fed rather than grain fed beef. Grain fed beef is fatter and more prone to being infected with Salmonella or E.Coli than grass fed beef.  There is a wider variety of taste with grass fed beef, and most who find grass fed beef end up preferring its flavor. Grass fed beef is best cooked with Sous Vide cooking.
(e) If you eat more calories than you burn you will gain weight. But it is more than just calories – it is also the types of calories. Eating high glycemic index foods mean you will spike glucose pushing it into cells, where it will be quickly transformed and stored as fat. Low glycemic index foods will be slowly burned  - thus, calorie for calorie with the Paleo diet plan you will tend to burn the fuel from the food as opposed to store it.
(f) If you eat a majority of your food with highly processed grains instead of whole grains you will have a faster rise in blood sugar. Some attribute this rise to increased obesity and an increased load on the pancreas.

Overall- this is not a bad diet program. Nothing in it would appear to cause nutrient deficiencies and there is some preliminary evidence that this diet keeps a person more satisfied with less food. It is a low-carbohydrate diet, and those diets, in comparison to other diets, tend to produce faster and longer weigh loss.

Here are a few scientific references- I’m sure we will add more as time goes on

Low incidence of fatal coronary heart disease in Pima Indians despite high prevalence of non-insulin-dependent diabetes. RG Nelson, ML Sievers, WC Knowler, BA Swinburn, DJ Pettitt, MF Saad, IM Liebow, BV Howard, and PH Bennett
Circulation. 1990;81:987-995

Food for Thought: Dietary change was a driving force in human evolution. Wm R Leonard. Scientific American. December 2002: 107-114.

A Paleolithic diet is more satiating per calorie than a Mediterranean-like diet in inviduals with ischemic heart disease. Jonsson, et. Al. Nutrition & Metabolism 2010, 7:85

Thirty thousand-year-old evidence of plant food processing. A Revedin, et al Proc. Nat. Acad. Sci, November 2010: 107:18815-18819

Dr. Esselstyn noted the risk of heart disease in rural China was low in the 1970’s – and presumed that they didn’t have a “western diet.” Now there are two flaws in his population statistics: First in the 1970’s in rural China most individuals were starving to death – it was the end of the cultural revolution and any source of food that could be found and eaten was. The second issue is if you examine data from The China Study you will see that heart disease mortality was lowest in the rural communities that were able to eat more meat. In The China Study (again, I promise this will be a topic later) – they used mortality statistics from the time during the end of the Cultural Revolution. Rural China was starving then, all trees had been used for fuel, there were virtually no birds left (combination of deforestation and hungry humans) and rice was used for the army.

Dr. Esselstyn then talks about Norway during World War 2, when they were occupied by the Nazi Germany, and how that heart disease diminished as the Norske were forced to eat a plant based diet. That was a great assumption to make, but when examining the data from Norway there are a few interesting factoids – Meat consumption dropped 60% but fish increased 200 per cent. Vegetables and potatoes increased but sugar decreased by half. And when the data is put to a microscope in 1942 and 1943 when mortality declined, animal proteins were still higher than before the war. It appears that Norway suffered from increasing fish (great source of Omega 3 fatty acids) and foraged for foods such as wild greens, grew and ate a lot of potatoes, but had a low amount of sugars and almost no margarine (I don’t know a respectable Norwegian today who cooks with margarine). The sad part of the war was the increase of mortality from infectious diseases – especially pneumonia (my mother’s cousin who fought for the resistance died of this, as did many of his comrades).

Norway in WW2 ate a lot of fish- and this roe was popular

He followed these patients for up to 12 years – his numbers are confusing as he started with 24 patients and six dropped out (leaving 18). One of the 18 died from his heart disease (leaving 17). At ten years there were 11 patients. They did angiography and reported a regression of 11 lesions with 14 remaining stable.

Angiogram- xray - of a plaque. Not enough to do surgery on though

When any study talks about a “cardiac event” it means to most of us a heart attack. If you have a small lesion in a coronary artery and then that lesion accumulates a blood clot that is what a heart attack is. The blood clot (from platelets – a sticky component of blood that helps you clot ) blocks the flow of blood to the heart muscle. If the clot blocks blood flow for a long time then the heart muscle dies and you have a myocardial infarction, if it opens up then all you have is a heart attack. This has little to do with the size of the lesion, and more to do with the complex chemistry of the coagulation system. Hence, taking aspirin a day or Plavix is more beneficial.

The other major problem with the study is that these individuals were on lipid lowering medications. Dietary reduction of lipid level (Cholesterol and lipoproteins such as VLDL, HDL) is about ten per cent on average, but never more than twenty per cent. However, lipid-lowering medications – such as Crestor – can remarkably lower levels of the lipids. In addition, lipid-lowering medications are best for reducing inflammation. They are anti-inflammatory to blood vessels, meaning in addition to lowering the lipids and cholesterol, their main effect is to reduce the chance of having a “coronary event.”

Crestor shown to be effective at decreasing the plaque in arteries

One of my cousins, preventing heart disease and eating fat

There is a lot of pseudoscience in medicine, and the reason that we have medical treatments that are quackery is because of the industries built around them.  This was made evident by the recent issues with the HCG diet. Contrary to what reasonable people would think, the new FDA ban on over-the-counter HCG did not shut down the industry built around HCG. The FDA states “HCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity. There is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or “normal” distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets”

There is an entire HCG diet industry kept alive by those who make their living promoting this weight loss method.  What has gone away is the ability of non-physicians to sell the drops, tablets, troches – all HCG must be prescribed by a physician. Within two miles of my home there are five places that advertise HCG diet. None of these places is a physician’s office. Whether the FTC or FDA cracks down on these is another matter.

These weight loss clinics sell the HCG –either by breaking the law and prescribing without a license, or they are finding a physician who will write the script without seeing the patient.   For a physician to write a prescription without seeing a patient is not only bad medicine it is unethical- and, at least in Arizona, would probably result in the physician being sanctioned by the medical board.

Because the FDA has, without equivocation, stated that HCG is not useful for weight loss, proponents of HCG are now circulating “articles” of “studies” showing that HCG works. But the HCG controversy provides a microcosm of how proponents of woo-woo medicine (medicine that is based on pseudoscience) use “studies” to promote their treatments.

The article that should have put the nail in the coffin of HCG was written in 1976 in the Journal of the American Medical Association. The paper was a study of 202 patients treated with either HCG or saline placebo.  The physicians administering the medicine did not know if they gave the patient HCG or if they gave the patient the saline (salt water). The patients did also not know.  All patients were placed on the 500 calorie diet.  At the end of the study, there was no difference between those who were given HCG and those who were given placebo in terms of weight loss. There was also no difference in fat loss. There was no evidence that those who had received HCT were more or less satisfied, and the dropout rate was the same. Thus, they could not prove what the advocates of HCG said- that people who use HCG along with the diet will feel better and adhere more to the diet, and that there was no more or less fat loss among those patients. This was the article that, temporarily, put the nail in the coffin for HCG.

The reasons physician-scientists consider this article a good article are: (a) The study was randomized so the patients did not know what they were getting.  This eliminates bias of the patient. (b) The physicians did not know what the patients were getting – eliminating the bias of the physician (c) The results were reviewed by non-bias staff (d) the study was prospective- meaning the subjects were followed ahead of time so the authors could not manipulate the data either way. (e) the article appeared in a journal that is peer reviewed, meaning editors read the article for its content, have the ability to ask the authors to submit raw data, and can spot bias.

That article, along with others, put away the HCG diet industry for a while, until 2007. In 2007 a book was written about HCG – by Kevin Trudeau, called “The Weight Loss Cure ‘they’ don’t want you to know about.”  The Federal Trade Commission fined Trudeau 37 million dollars for making false statements in this book. Oddly enough book is still sold, and many of the “HCG weight loss coaches” make money selling it.  The book is bunk, by the way – total, complete and utter nonsense promoting HCG.

This silly book resurected a bad diet

Contrast the great article in JAMA with an article that the HCG coaches are currently recommending, by Dr. David Bryman, an osteopath from Scottsdale, who published a non-randomized study with a higher protein low calorie diet- showing the HCG had more weight loss (The Bariatrician – 2010 Vol 25, page 11). The problems with this study are several: first there is no randomization, second there is no control, third there is no blinding, and fourth there is a clear bias, fifth the article is retrospective  – so it can come to the conclusion it likes. The article is worthless.

Having “journals” gives people who practice pseudoscience (be it chiropractic, acupuncture, homeopathy) a sense of legitimacy. Sadly, those journals do not follow scientific principles of research, evidence or science-based medicine.

Confirmation bias is a bias hard to overcome. This is seen in the HCG diet industry. If you attribute weight loss to HCG, then everyone who loses will confirm your bias that it was the HCG.  It is clear that it is the diet – whether it is a high protein 800 calorie, or the original 500 calorie diet, that will provide the weight loss.  However, the people who sell it, or the books and meal plans, are convinced that the HCG is doing the work- in spite of the lack of science supporting their claim.  Much like acupuncture, or homeopathy – if someone believes it, and then is confirmed by placebo effect, it is difficult to overcome that bias.  Add in that a part or all of one’s living is made by some pseudo-scientific endeavor and the pseudoscience becomes a religion.

It is difficult to convince someone their “experience” is not accurate or even that their “experience” isn’t what they think it is.

HCG shows the ultimate “placebo” effect.  A placebo is a pill or injection that has no active substance in it – commonly a sugar pill or a saline injection.  Placebo comes from Latin, meaning “I shall please.”  To test whether a chemical, hormone, or some agent works, you have to test it against a placebo. Some people, 35-55% of them, with some diseases, will have an equal effect with a placebo as with the hormone tested (in this case HCG). Placebo works best with nebulous things that cannot be measured- like appetite. As was shown in the JAMA study when HCG was compared with saline injections, there was no difference.  HCG works by placebo effect.

The problem is that HCG is not a placebo.  HCG is a hormone, one that has effects that can be long lasting and harmful. We don’t know if the hormone has a tumor promoting effect as other hormones do (estrogen with breast and uterine cancer and testosterone with prostate cancer, HCG may have tumor promoting effects – it certainly can increase venous thrombosis). The other problem is physicians who prescribe this are giving legitimacy to a treatment that does not work, and can cause harm. They are also placing themselves at risk by stating they have evaluated a patient

As with all pseudoscience- there are people who firmly “believe” in this without a shred of legitimate evidence. Proving that having a degree (MD, DO, RN) does not make one a skeptic, and clearly degrees do not teach people how to think and apply the scientific method. Many in pseudoscience use the logical fallacy of an appeal to authority – e.g.- a doctor prescribed the HCG, and a nurse is my coach so it must be good.

In terms of the other scams in medicine- Homeopathy is one that actually has a board sanctioned by the State of Arizona. It isn’t odd that Arizona is so backward, after all, it is the wild west. But I like the quote from Dr. Zina Pitcher, when the State of Michigan tried to force the University of Michigan to have a homeopathic school:

…shall the accumulated results of three thousand years of experience be laid aside, because there has arisen in the world a sect which, by engrafting a medical dogma upon a spurious theology, have built up a system (so-called) and baptized it Homœopathy? Shall the High Priests of this spiritual school be specially commissioned by the Regents of the University of Michigan, to teach the grown up men of this age that the decillionth of a grain of sulphur will, if administered homœopathically, cure seven-tenths of their diseases, whilst in every mouthful of albuminous food they swallow, every hair upon their heads, and every drop of urine distilled from the kidneys, carries into or out of their system as much of that article as would make a body, if incorporated with the required amount of sugar, as large as the planet Saturn?

The power of the purse did cause the school to come to the University of Michigan, although eventually the Supreme Court did state that the Regents of The University of Michigan were not answerable to the legislature.  The homeopathic school was merged into the medical school in 1920′s – and homeopathy was gone for a while. Sadly- it is back.

Heart artery plaque- low fat diet doesn't prevent this

Never has it been more clear that publishing a paper in a respected journal can lead to a career. Even if the science has changed it. It has been 15 years since Dean Ornish published his data showing a 3 percent reduction in the plaques seen by coronary angiograms on a select group of patients who followed his diet and “lifestyle” plan.  To be exact: they found 1.75% improvement after one year and 3.1% improvement after five years.  Where the control group increased by 2.3% in one year and 11.8% at five years. This was a group of 28 patients who followed his diet to the letter.

In 15 years no one has reproduced that data. No one. In medicine we see a lot of data come through, when it is not reproduced, or unable to be reproduced by others we look at it with a very jaundiced eye. Or to be blunt – we don’t believe it. Yet, his data, with all the issues it has- is still touted by a few in the popular press as “proof” that the “low fat” works. We have levels of evidence in medicine, and while Ornish attempted to get to the highest level of evidence, by having a control group – he fell short with several major statistical issues: (a) his study does not contain enough people to be anywhere nearly significant (b) one cannot rely on angiographic photographs which are interpreted in many different manners (c) one cannot control outside factors, exercise, BMI, smoking cessation.

In contrast, we now have an entire group of lipid medications. A recent study in New England Journal of Medicine showed how that Crestor had produced a regression of plaque in 63% of the individuals.

Lets be clear- the medication data is using far more sensitive instruments to measure plaque. Intra-vascular ultrasound where they thread a tiny ultrasound probe into the artery and  measure the plaque precisely.   In the Ornish data, he used photos of angiograms ( show two cardiologist the same angiograms and you will get two different interpretations of it – angiograms are not precise). The medications show specific reductions in plaque- not everyones – unlike Ornish. It is rare that anything does 100 per cent to everyone.

When looking at angiograms- like Ornish did- the interpretation of them is so variable, that no scientific publication today would accept that data, or its interpretation. The small amount of plaque reduction is too small to be anything but observer bias.

Two views of the same image- angiogram interpretation is flawed

Still, from one old paper- Dean Ornish has made a career, being the anti-Atkins, and riding the anti-cholesterol, low-fat band wagon with the same religious fervor as Keyes did thirty years ago (see my earlier post about that).

The difficulty is this: science has caught up with us, and we know a lot more about how plaque forms and doesn’t form. We know that dietary cholesterol is far less important that what the liver makes. We know that the dietary component may be far more related to the triglycerides – and they are raised far more by the grains and pastas that Ornish loves.

Still, Ornish is the lead health-blogger for Huffington Post, has influenced Bill Clinton (see the previous post) and is favorably mentioned by Dr. Oz. He still argues against those who advocate any “low carbohydrate” solution, based on his “empiric” data.

Personality, the willingness to believe in  your hypothesis no matter what science says, and the desire by the public to see “natural” leads to a great career in politics, and entertainment. For most scientists, Ornish’s paper isn’t a breakthrough, but borders on confabulation.

There is always another “fad” diet out there- and the HCG diet hopefully died when the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued letters to companies warning them that selling “homeopathic” HCG weight-loss drugs was not FDA approved and that there was no evidence of the claims, thus violating FTC rules.

HCG is a hormone that is produced by the human placenta during pregnancy. Clinically HCG is used as a fertility treatment, and can lead to increase in progesterone and testosterone, which have consequences of their own including deep vein thrombosis (a clot in the veins of the lower extremity) leading to pulmonary embolism and even death. This is not a benign hormone, and should only be used under the strict supervision of a physician – who knows what they are doing, not a naturopath or homeopath, or chiropractor. HCG is also elevated in some cancers, and we follow HCG levels to determine how effective our cancer therapies work with some tumors. This is also the hormone most use to determine if a person is pregnant.

This fad diet started in the 1950’s when Albert Simeons, a physician working in India, noted that pregnant women on a low-calorie diet lost fat rather than muscle and the fetus was protected. He hypothesized that the HCG reprogrammed the brain to lose fat rather than muscle, thus protecting the body against loss of muscle. Simeons went on to become an entrepreneur founding weight loss clinics, manufacturing centers, and having widespread use of his product. There was no evidence for HCG working and the diet died in 1976 after an article in JAMA showing that there was no difference between patients who received HCG and those who received a placebo. In 1976 the FTC ordered the Simeon Weight Foundation and HCG Weight Clinic Foundation to stop claiming the HCG was safe and effective, and the FTC has required labeling and advertising of HCG to state:

Albert Simeons- went from working in India to making a fortune in weight loss

HCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity. There is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or “normal” distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets

HCG was reborn in 2007 with the book, “The Weight Loss Cure They Don’t Want You to Know About,” by Kevin Trudeau (if you watch infomercials you have seen him – the infomercial guy). Shortly after the FTC charged Trudeau with violating a court order and misrepresenting the contents of the book on his infomercials. He was ordered to pay 37 million dollars for violating their order.

This silly book resurected a bad diet

Still, that started a new industry with companies manufacturing products that could be sold out of major drugs stores, injections given in drive-by diet centers, and lots of people touting this as the cure to obesity. The manufacturers decided if they would slap the “homeopathic” label on it, they could get by with selling this over-the-counter and make even more money off consumers. The FDA stopped this nonsense- not only because this is a potentially dangerous hormone, often given without strict medical supervision, but because the very low calorie diet that goes with it should be done under the supervision of a physician also.

The reason we won’t see the HCG end is because physicians can still prescribe injections of HCG – even though this is not a diet that will work. There are still unfortunates who think getting an injection of this hormone will work- and as PT Barnum once said “there is a fool born every minute.”

The HCG proponents are filled with confirmation bias.  They lose weight, so they assume it is the HCG that suppresses appetite – although there is no evidence it does.  They then will cite articles in non-peer reviewed journal  such as Dr. David Bryman, an osteopath from Scottsdale, who published a non-randomized study with a higher protein low calorie diet- showing the HCG had more weight loss (The Bariatrician – 2010 Vol 25, page 11) . The problems with this study are several: first there is no randomization, second there is no control, third there is no blinding, and fourth there is a clear bias.  To put this in perspective- this study has less validity to it than a noted expert opining.  This study does not rise to acceptable levels of Evidence based medicine. Sadly, the HCG proponents, including health care professionals, do not understand the value of the evidence based medicine that clearly demonstrated no efficacy of HCG in any study in a peer reviewed journal.

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm281333.htm

The action of chorionic gonadotrophin in the obese. Simeons ATW. Lancet 2:946-947, 1954.

Chorionic gonadotropin in weight control. A double-blind crossover study. Young, Fuchs, and Woltjen. JAMA. 1976 Nov 29;236(22):2495-7.

Who would have imagined that my patient, Evo, would have lost 14 pounds on the “beer and sausage” diet (now called the Evo diet).

From the medical side there are two other benefits — his triglyceride level dropped by half, his cholesterol dropped by a third, and his “good” cholesterol increased.  There was never an increase or a blip in any of the liver enzymes.  His fat mass dropped, the only non-fat mass of his that decreased was that tissue associated with and supporting the fat mass (I know, sounds complicated).  His muscle mass maintained itself.

One important lesson learned: we do not know enough about science and medicine and diets to be able to say anything to anyone about which diet is healthy and which is not. But let me give you an example – we had more data points for this one month of the Evo diet than Ornish had for his diet program.

The famous Ornish line is that his data showed a decrease in “Plaques” of patients who had heart disease. This was based on less than 20 patients, including the control group.  He has since gone on to show poor data with prostate cancer, as well as aging. The data that Ornish has isn’t good, and when you look at the data we generated in one month from the Evo diet, one could assume that we would find people would do better not doing the Ornish diet and following the Evo diet.  This is said with a smile, because never has a “lifestyle” and diet – such as Ornish, been propagated with less data and more press.  Ok- there is also the China Project (a single misuse of data to say the same thing).

The second important part of Evo’s diet was this: there was a simple and yet profound control of the portion sizes that he had. It was measured, it was regulated to around 1500 calories per day.  Based on that,  Evo lost more than we would expect him to have lost. Why? No clue.

What can you take away from this: First, if you want to have a diet begin by strictly regulating portions. Portion control is a key for any weight loss, including weight loss surgery.  Limit your portions, and thus your calories, and you should lose weight.  The advantage of beer and sausages is that they come in nice units that you can measure.

Processed meats appear to increase risk of colo-rectal cancer

What you should NOT take away from this: beer and sausage are not “diet foods.” Beer and sausage were, in this case, a tool for great portion control. And Evo ate more than just sausage. He ate what came with it.  When I cooked for him he had the peppers and onions that went with my famous recipe (recipe will be on terrysimpson.com later). He had bread (yes, I know some of you think bread is the devil’s tool) – if it came with the sausage.

The final message is most important- We don’t understand food as well as Ornish, Atkins, or pick some diet guru would have you believe.

Sometimes all you want for breakfast is a cup of coffee-- and that's ok

Everyone knows:  Always   eat Breakfast

There   are   a lot   of   variations   of   this   axiom.

“Breakfast   is   the   most   important   meal   of   the day.”

“Breakfast makes it so you won’t be hungry later.”

“Breakfast jump starts your metabolism”

“You need to eat a large breakfast”

“Breakfast   is   the   most   important   meal   of   the day.”

All of those are FALSE.

Breakfast is NOT the most important meal of the day- so don’t force it. The reality is that most people are not ready to eat breakfast when they first wake up.  So why does “everyone” say this? Some of this data was based on the Iowa Breakfast study- which was more than a single paper- but a group of observations made over a number of years and published. There have been a number of other studies showing that kids who eat breakfast do better in school than kids who do not. However, there are a lot of variables not accounted for in those studies.

In addition- a few other items were not taken into account: if you wake up at 4 am to do chores until 7 am, then have breakfast and go to school, you will do better in school than someone who wakes up at 4 am, does chores and doesn’t get breakfast.

Regarding most breakfast studies — funded by, and poor research  done, from cereal companies. Doesn’t mean they are bad studies- but they all fall into poor categories of evidenced based research.

“Breakfast makes it so you won’t be hungry later.”

A recent study showed that people who eat a large breakfast are not affected by how much they eat later in the day. Meaning that eating a large breakfast won’t keep you from snacking, or eating less the rest of the day.

You wonder where people come up with this idea– but when it is put to the scientific test- the breakfast you consume does not reduce food you consume later. Not one bit. No relation- no correlation.

Breafast buffet is not your friend

“Breakfast jump starts your metabolism”

They also found that eating less in the morning contributed to overall weight loss (if you eat less calories you will lose more weight).  There is a simple truth about weight loss – if you eat more calories than you burn, you will gain weight. If you eat big breakfasts and lots of other calories you will gain weight.  Breakfast does not jump start your metabolism- your body does that.

Again- how would you measure a “jump start” to metabolism? There are ways- but activity itself increases heart rate, breathing, and over all muscle activity. If you take comatose patients and measure their oxygen consumption and carbon dioxide production- and cycle feeds – the feeds do not increase metabolism. Another study took college football players and put them into a hospital and fed them. They were allowed to do a few walks- but not much more.  It was activity that increased metabolism- not food. Any food will increase some metabolism – but a breaking of the fast does NOT do any sort of jump start.

“You need to eat a large breakfast”

Want to just have a smoothie or yogurt or some oatmeal to start your day? Go ahead. You want to wait for a couple of hours after you get up before having something to eat- that works too. But if you eat a large breakfast – you still need to work off those calories.

You think this is an important meal?

The great thing about breakfast foods: You can eat them anytime! Who doesn’t like eggs for dinner? And after a long day- nothing is more refreshing than a blueberry smoothie to take the edge off hunger, and let you relax for a bit.  We have recipes for smoothies containing micronutrients, fibers, and supplements – a simple smoothie can be a pleasant treat after a long day of work, taking the edge off hunger so you can make a great dinner.

For the smoothie and other recipes go to terrysimpson.com

Week one:

Down six pounds- two of it fluid. One week- beer and sausage.

My assessment: he is healthy, fit, full of energy. Evo is working hard at keeping his beer and sausage calorie consumption to less than 1500 calories a day. Since he burns around 2100 a day- he should lose at least a pound a week -or over the course of the month- four pounds.

Why the big drop? Two pounds of it are from total body water – and that might be the diuretic effect of the beer. His fat loss is also about two pounds.  Those numbers are somewhat exact – the weight loss is real.

Will this “diet” work?  Yes,  much like a thousand other diets, limit your calories, use just one food group or a couple, and you will be fine.  Lets add a bit of fine print here: we are following Evo’s cholesterol level, liver chemistries, and a number of other tests to make certain he isn’t getting into trouble.  He is also going to be taking a multivitamin daily. Also some fiber daily. If “German” things come with the sausage – he can eat that.  Sausage and Peppers – for example, or sauerkraut - he can have those.  What he can’t have are the side dishes that are processed – no breads, no potatoes, no rice, no pasta.

Today in the office we discussed the huge difference between this and the Paleo-diet.  In the days of the caveman they drank water- most illness was transmitted through water. Beer is highly purified, has nutrients in it- and while some will say it is evil – it really isn’t. I suspect those who say it is evil are those who are the “pure food” people- similar to “raw” or “vegan” – there is a self-righteous superiority about people on diets.  So- if Evo drank water from the streams (we live in Arizona, so that is difficult) he would probably become ill. Sausage – another processed food- which is meat. While “processed” has a bad name (as bad as an Atheist naming their son Christian) – think about cavemen and meat.  You haul in this big bison, wildebeest, or huge creature– most of it will become rancid and cause more illness quicker. But then we became smart and learned how to process and preserve meats. We have eliminated another cause of early death of the paleo-types – death from botulinum toxin, or salmonella (much worse in those days than today).

So Evo’s diet will lead to a longer life than if he followed a true Paleo-diet. Later in this series we will take a skeptical eye to that particular diet and its failures as well as its good points.  For now- take this as the humor it is meant to be — a caveman in Phoenix would lose more weight on the Paleo-diet than Evo will because they would become sick and die.  We will make certain that doesn’t happen to Evo.

Good job, Evo- first week. Great weight loss, more than expected.

I don't know much about beer - but I'll bet Evo likes this one.

Imagine a way that the government could reduce the level of obesity and it would cost nothing.  The government had that chance- and they blew it.

The US Department of Agriculture denied a request by New York State to run a pilot program where the city of New York would not allow people to purchase soda, or other sugar sweetened beverages, using food stamps. There are at least seven other states requesting such pilot programs.

It is not surprising that the opposition to this proposal came from the beverage industry who said, “It’s another attempt for government to tell people what they can and can’t drink. Singling out one specific item is discriminatory and unfair.”

Really? No one is saying they can’t drink soda – simply that the government won’t purchase items that are not in line with the intent of the food stamp program which is, “to provide for improved levels of nutrition among low-income people each month.”

The USDA said that city retailers would not be prepared to implement the new policy.  The food stamp program is run with a debit-style card. If a beneficiary is purchasing items from the grocery store not covered by food stamps, such as tobacco or alcohol, the cashier collects the money for those items after the food is deducted.

The original Food Stamp Act prohibited purchase of “soft drinks,” but that was changed because of regulatory issues-, which are now overcome thanks to technology. In fact, New York City officials stated that the “program’s electronic benefit card looks and acts like a credit or debit card” and that it only covers “some of the items in a typical s hopping cart, so program participants are already accustomed to supplementing their purchases with personal funds.”

The USDA also said “the proposal lacked rigorous methods to asses changes in sugar sweetened beverage consumption resulting from the new policy and the effects of those changes on obesity and health.”  A pilot program doesn’t have to prove that sugar sweetened beverages are not “food.” Even the original act prohibited these items.

The government purchases millions of gallons of sugar laden drinks for food stamp holders every day. Obesity is the number two killer in the United States – and by denying this simple pilot program are paying for obesity.  Preventing obesity costs nothing – paying for the effects of obesity costs everything.

References:

US Department of Agriculture. The Food Stampe Act of 1964. http://www.fns.usda.gov/snap/rules/Legislation/pdfs/PL_88-525.pdf.

Jessica Shahan, Associate-Administrator, Supplemental Nutrition Assistance Program, USDA, to Elizabeth Berlin, Executive Deputy Commissioner, New York State Office of Temporary Disability Assistance. August 19, 2011.

Scott-Thomas C. Food stamp soda exemption in NYC is discriminatory, says industry. Food Navigator-USA. May 5, 2011. http://www.foodnavgator-usa.com/Business/Food-Stamp-soda-exemption-in-NYC-is-discriminatory-syas-industry

JAMA, September 28, 2011 Vol 306, No. 12 page 1370-1371