The newest diet “science”

As noted yesterday, there is one diet fad that has misled so many people to believe is credible and scientific, that the Wellcome Trust, a biomedical research charity based in London, has made it the subject of an ethical inquiry. It’s The DNA Diet, which claims you can lose weight and even live longer and healthier by eating based on an analysis of your DNA. In a Guardian article last week, scientists warned consumers about companies marketing these “nutrigenomic” diets on the internet. These companies are charging about $2,000 for a genetic test and personalized diet plan claimed to counter someone’s genetic predisposition to certain cancers, diabetes, heart disease or obesity.

There is no science to support these “pie in the sky claims.” They stem from the Human Genome Project, according to Dr. Alison Stewart, chief officer of Cambridge Genetics Knowledge Park. Over the last couple of years, new terms have emerged to describe and legitimize these fields: nutrigenetics and nutrigenomics. Their exact definitions vary, “but most seem to use nutrigenomics to describe the ‘functional’ interactions of food with the genome at the molecular, cellular and systemic levels; while nutrigenetics refers to genetically-determined differences in how individuals react to specific foods,” she said.

The problem is, said Stewart, genetics is much more complicated than single genes. Our health is, too. Professors at Wageningen University, Netherlands, outlined the scientific uncertainties and complexities of nutrigenomics, and went on to describe the ethical implications, which they said overshadow potential health benefits.

In a comprehensive review of the evidence for Quackwatch, doctors Stephen Barrett and Harriet Hall concluded that companies “offering genetic testing with guidance on diet, supplement strategies, lifestyle changes and/or drug usage they claim can improve health outcomes,” are dubious, have potentially serious harmful implications and should be avoided.

According to Helen Wallace, Ph.D., Deputy Director of GeneWatch UK: “For most people, tailoring your diet to your genetic make-up is about as scientific as tailoring your diet to your star sign.” Dr. Serge Jabbour, endocrinologist at Thomas Jefferson University in Philadelphia, told Ivanhoe Broadcast News last month that he thinks DNA diets are just a way to make money and that he “really doubt[s] that at some point in the future, we’re going to discover that a certain gene is going to be responsible for weight gain based on certain foods....or that genetics is going to help with weight loss.”

Nutrigenomics takes nutritional science beyond what can be soundly demonstrated in preventing nutritional deficiencies, to unsupportable beliefs in special health-promoting or preventive qualities of certain foods and supplements, or specific evils of others. It plays on the most zealous beliefs in good and bad foods. The human species is also 99.9 percent the same genetically; with the remaining 0.1% of variation accounting for physical differences that are visible and invisible, such as disease-risk. This lends doubt to the efficacy of pharmaceutical and biomedical treatments based on genetics or race/ethnicity. But both the food and medical industries recognize the huge profit potential of nutrigenomics and nutrigenetics. By testing people for their genetics and identifying people that may have markers for vulnerability to certain health problems, they hope to market foods and medicines targeting specific genotypes.

This past February, 88 researchers joined in a global initiative to establish nutrigenomics as a new “multidisciplinary science” and set up a genomics databank. The new National Center of Excellence in Nutritional Genomics at UC Davis is leading this initiative, supported in part by the National Institutes of Health. Other nutrigenomic ventures include WellGen, Inc., spun from Rutgers University, New Brunswick, NJ, which notes that the nutrition industry is a $182 Billion industry with a huge potential for growth and profit. In February, it completed a $3 million Series B financing and its website said it raised about $8 million in investor financing in 2004-2006. Jeffrey Bland, president of Metagenics, another nutrigenomic company, spoke last year at the Second Annual World Obesity & Weight Loss Congress about the potential for nutrigenomics. Metagenics already holds multiple patents and “produces over 400 all-natural, research-based products to ‘optimize health.’”

But concerns are growing about genetic testing being used to evaluate individuals and how this information might be abused by insurance companies, healthcare organizations, employers and the government to compel compliance with certain lifestyle or medical interventions. The Council for Responsible Genetics based in Cambridge, Massachusetts wrote of hundreds of cases where genetic information has already been misused to discriminate against people with undesirable genetic findings.

Commentary: As the diet season begins and the obesity hype is sure to go into high gear, remember that no weight loss method has ever been shown to be effective long-term, and none are benign. The soundest New Year’s resolution of all may be to ignore the weight loss tomfoolery and find something more valuable to do with your time, money and energies.

Click here for complete article (and single page version).

December Diet Wackiness

We were inundated by diets this month — and it’s not even January! Some diets were variations on oldies, others took eccentricity and whimsy to entirely new dimensions. But they all demonstrated what Shmuley Boteach wrote in the Jerusalem Post:

If you want to make a quick buck, just pen a book about a new diet you’ve conjured up, give it a sexy name and presto, you’ll be an instant millionaire. No previous writing experience needed. You might try and call it something like The Emaciated Scarecrow Look or Thin is In. Better still, name-associate the book with something really chic like The Rodeo Drive Diet or The Fifth Avenue Starvation Plan and you'll be retiring in six months. [Maybe, that’s my mistake. :)]

The Compliment Diet is a creative plan that directs husbands to give their wives a daily compliment telling her how slim and beautiful she is (being sure to turn off the TV first). Within weeks, it promises, women who’ve been “letting themselves go,” or compensating for lack of affection by eating, will start working out and go on a diet.

The SOS Desperation Diet promises you’ll lose a dress size in a week, just in time for your holiday party. It also promises better skin and sparkly eyes, that you’ll feel more energetic, “and all the things you want when you are going to a party.” It assures prospective customers that it was devised by a naturopath so “it’s perfectly safe...and has been very carefully thought out.” It’s secret is “just good, healthy food, a little light exercise and some herbal tonics to help kick-start your metabolism and flush out any toxins.”

The Wine Diet is not about drinking any old wine, it’s about being selective and choosing wines from older vines grown at high altitudes which are claimed to have more beneficial compounds. The idea is to combine wine with a “healthy lifestyle” and a 1400-calorie diet which includes wine, dark chocolate and fruit.

The Nasal Spray Diet promises to treat obesity by eliminating the sense of smell and taste. The company already has a patent on its nasal spray which they say works to reduce food intake. This is called a “forward looking statement.” Don’t look for their spray until 2010, as clinical trials won’t begin until 2007 and then it has to get FDA approval. But the developer expects to raise $50 million with an initial public stock offering.

The George Orwell Diet describes “newspeak, doublethink, thoughtcrime and now, coming to a city near you, dietcontrol where the ‘thought police’ decide your every move and your diet.” The idea is to ban foods that Big Brother of Oceania thinks might be fattening or bad for you. This diet is for people who “believe government is looking out for our good.”

The All-Beer Diet is essentially a low-carb diet geared for guys who drink beer. For “real,” there’s a book. The author says he did his own research for 25 years of trial and error, losing and gaining back 593 pounds, and says he now has “conclusive proof” of what worked to lose 114 pounds.

The Hypnosis Diet promises to teach you a simple hypnotic technique that will eliminate cravings for “junk” foods and make you exercise more.

The Beauty and the Beast Diet claims that Candida yeast causes cravings for sugar and starch, depletes your body of nutrients and releases toxins that make you fat. It offers a yeast test and promises that with anti-fungals and natural supplements, you too can lose 180 pounds, 125 without exercise. This diet isn’t new, as beliefs of yeast-related sensitivities, allergies and health problems have been around for years, along with that candida questionnaire.

The Master Cleanse Diet is so risky and ridiculous I hesitate to even describe it. By living for ten or more days on nothing but a concoction of lemon juice, cayenne pepper, maple syrup and water — up to 12 glasses a day — along with salt water in the morning and laxatives in the evening, it says you’ll wake up thinner and no longer grumpy. This 650-calorie diet actually isn’t new and was created in the 1940s but given new life recently on the Oprah Show. The Internet is filled with claims it fights disease, clears the mind and skin, and increases energy. Dieters are warned that it’s best to stay close to a restroom.

The Oomph Diet includes an online “Rollover Calories” tool to help dieters track their unused calories throughout the week, sort of like rolling over minutes on your phone service. It’s for calorie theory believers only.

The Diet Detective’s Count Down Diet is another one for calorie theory believers who think calories are like money and can be balanced like a checkbook. It lists 7500 foods and tells what will be needed to burn the calories in those foods.

The Ultimate Sex Diet is also along those lines, promoting weight loss through “sexercise,” since it says that a half-hour romp under the sheets burns the same number of calories as a 30-minute brisk walk.

The Idiot Proof Diet promotes itself as a revolutionary web-based diet that computes everything for a dieter in seconds and “creates a personal daily menu that ensures ideal calorie shifting” to guarantee weight loss. Its guiding principle is that people are fat because they eat the wrong foods, the wrong types of calories and at the wrong times of the day. Its solution is a new “shifting calories theory” that promises by constantly shifting from one type of calorie to another, the scales will keep dropping.

The Skinny Me with Green Tea Diet creator claims that by simply drinking green tea and eating a “healthy, whole food diet” she lost 170 pounds in about a year. Her secrets include eliminating processed foods, pastas, breads, meats, fried foods and drinking lots of water. She sells an assortment of weight loss products, including a special cream she claims eliminates stretch marks and wrinkles, and a greener green tea (Uji Gyokuro “Gyoku-Hou”).

The Grapefruit Diet which prescribes a grapefruit before every meal to lose weight is still going strong after 40 years. The most amazing thing about this diet’s longevity is that its mythology continues to be believed, even by registered dietitians, and that they are actually getting funding for research.

The Purina Diet is the funniest diet circulating the internet this month. It is well worth a read! Believe it or not. :)

But there is one wacky diet that so many people are being taken in by, and believe is credible and scientific, that it has become the subject of a major ethical inquiry. We’ll reveal that tomorrow in “The newest diet ‘science.’”

Click here for complete article (and single page version).

Pediatric Grand Rounds 2006

Pediatric Grand Rounds has just been posted at Breath Spa for Kids. Perhaps in response to the general zeitgeist or because it’s the last Pediatric Grand Rounds of the year, the articles written by these medical professionals are exceptionally thoughtful, inspiring and fascinating to read. The host, Shinga, writes: “Most of us are fortunate enough to live in societies where we have fortified the banks of paediatric health against the erosive forces of disease, morbidity and mortality. We live in good housing, we have clean water, standards for air quality, good nutrition, safety standards, improvements in medical science and public health measures such as vaccination. Most of us can be confident that children will survive through to adulthood.”

Dr. Flea’s excellent series on childhood vaccinations, recommended here last week when I wrote about the most common fears and myths surrounding vaccines, is the highlighted feature and deserves a second read by medical professionals, parents and everyone working with children. As Shinga noted: “It is sobering to recall what a comparatively recent privilege it is that children survive through to adulthood.”

Also deservedly mentioned is Nobel laureate Robert Fogel’s book The Escape from Hunger and Premature Death, 1700-2100, which chronicles the good news about our health and larger sizes, explaining that until fairly recently, most people battled a series of infections almost all the time, and that people (particularly children) expended a substantial amount of their calorie intake on fighting infection. It is a relatively recent development that we are so secure in our access to adequate calories that children can become larger and healthier. This realization may help people understand that the “childhood obesity epidemic” is not the crisis it’s being portrayed.

This is the best Pediatric Grand Rounds yet and includes sex, drugs, issues of life, death, morality; ethical dilemmas that reflect religious and cultural values, as well as the challenges posed by advances in medicine. Thank you, Shinga, for a great job and for including this blog in this memorable edition.

Click here for complete article (and single page version).

Salt’s pedigree

They come in an array of sparkling shades and shapes with exotic names like Black Kala Namak from India; Fleur del Sel from Guerande, France; Himalayan Pink Gos Sel; Hawaiian red clay salt; Maldon sea salt; and Korean bamboo sea salt. Salt tastings are all the rage, salt samplers are among the choicest holiday gifts, and chefs tell us each salt has a different flavor and has to be used to its best advantage in cooking. Sea salt tastes a lot better than mined salt, Rocco DeSpirito told the New York Times. “It’s got a real saline, ocean character that comes across in the food.”

Thanks to celebrity chefs, popular cookbook authors and gourmet catalogs, entire mythologies have developed about salts and their healthful virtues. Culinary gurus talk passionately of various salts and continually try to outdo each other for the most alluring, exotic and lavish offerings. And salt fads are born. Gourmet salts can now sell for more than 100 times the price of plain table salt. For most of us, following these food fads seem harmless fun. It never occurs to us it might not be.

Often taken as gospel are claims that sea salt is unrefined, more natural and more healthful than ordinary table salt because it comes from the sea and is high in minerals. Sea salt has been praised for tasting pure, fresh, bright, delicate, sweet, sharp, refined, balanced and well-rounded. Everyday table salt is condemned as tasting bitter, tinny, metallic, acrid, characterless, and chemical-like, because it’s said to be cheap and highly refined.

In actuality, all edible salt sold is about 99% pure sodium chloride. The remaining 1% — negligible traces in a dish — are far too minute to make a difference nutritionally. Scientists tell us that those minuscule amounts of minerals are also undetectable by our taste buds, but it’s easy to convince ourselves otherwise when we’re paying so much for them. :)

Salts do not differ in their saltiness or tastes. What we confuse with a bright salty flavor has nothing to do with the exotic origin of the salt, but more with the size and shape of the grains. When we bite into a big, crunchy crystal, we get a burst of salty flavor on our tongue. But when a fancy salt is dissolved in a moist or cooked dish, its special taste attributes dissolve too, leaving food tasting indistinguishable from that salted using a salt shaker.

Despite popular beliefs, sea salt is not rich in the minerals found in sea water because those are left behind when the sodium chloride crystallizes out as sea water evaporates. It is Mother Nature’s natural refining. Sea salt is ten times freer of minerals than sea water.

Some of the most amusing claims surround salt’s freshness. Salt doesn’t change when it’s exposed to oxygen and it doesn’t contain volatile, aromatic oils that can be released by grinding. So “fresh”-ground is an oxymoron.

We don’t dare admit that we can’t taste any difference among salts, though. We might appear to have an “insensitive palate!” So we choose to ignore the scientific reality or let ourselves get swept up in the fun of the popular fad. But when we forget our food history, we can find ourselves having to relearn the same hard lessons of our great grandparents.

Old fashioned, salt shaker salt differs from most gourmet varieties in one very important way. Since the 1920s, most table salts have had iodine added. Today’s trendiest salts haven’t. Sea salt contains less than 2% of the iodine in iodized salt, despite beliefs that it is naturally iodized (perhaps because some associate it with iodine-rich seaweeds).

Iodized salt was the first “functional” food. Chicken feed was also supplemented with iodine, it was given to milk cows and cattle to prevent hoof rot and reduce fertility problems, and was used to sanitize milking teats (now a waning practice), so eggs and milk products can also provide some iodine. What led up to iodized salt isn’t widely known anymore. Prior to iodized salt, Americans in many areas of the country were deficient in iodine. It was not uncommon for children in some regions to be considered “dull” or “dim-witted” with IQs 15 points below children from areas where iodine deficiency was less common. During World War I, goiter (from severe iodine deficiency) ran as high as 64% in some areas, and it was the biggest single cause of medical disqualification for military service!

By 1955, about 76% of American homes used only iodized salt. Where salt is adequately iodized and people are not limiting their food choices, deficiencies are rare.

Iodine is a natural element needed by the body to make thyroid hormones and is essential for normal growth and development of our nervous system (brain), sexual development, to maintain fertility, regulate our metabolism and maintain our body temperature. Adults with insufficient iodine in their diet show signs of hypothyroidism and women have higher rates of miscarriage; infant mortality is higher in babies; and children are at risk for reduced intelligence and can suffer permanent mental retardation, neurological defects and growth abnormalities.

The U.S. Institute of Medicine’s recommended dietary allowance (RDA) for iodine is 150 mcg for adults and adolescents, 220 mcg for pregnant women, 290 mcg/d for lactating women, and 90-120 mcg for children aged 1-11 years.

But over recent decades, Americans are increasingly shunning ordinary table salt; and commercial restaurants, food processors and chefs have abandoned iodized salt in response to consumer concerns it could affect the taste of foods; preferring “natural” sea salts, kosher salts and noniodized salts. Last month, Food Technology reported that this fad, along with attempts to reduce salt intakes, may be the most significant factor leading us to deficiencies again. The National Health and Nutrition Examination Surveys found that from the 1971-1974 to 2001-2002 examinations, iodine excretion in adults dropped from 320 mcg/L to 168 mcg/L — by nearly half — and the frequency of iodine deficiencies in pregnant women jumped from 1% to 7%.

These are astounding changes. While iodine levels are not yet low enough to declare a public health emergency (remember, RDAs are not minimum requirements and are set higher than most people need to prevent deficiencies to allow for a safety margin), they indicate a trend of serious concern to health professionals.

This summer, researchers at the Conway Institute of Biomolecular & Biomedical Research at the University College Dublin reported that the iodine intakes among Irish women of childbearing age were significantly below World Health Organization recommendations. They reported that a mere 3.3% of all salt sold in Ireland and UK was iodized. This past spring researchers reported in the Medical Journal of Australia that iodine deficiencies were re-emerging in Australia.

A week ago, the New York Times reported that about one-third of the world’s population eating only locally produced foods is short on iodine, contributing to stunted growth among the children and “even a moderate deficiency lowers intelligence by 10 to 15 IQ points, shaving incalculable potential off a nation’s development.” Multiple international iodizing efforts are underway, just as the United States did in the 1920s. Meanwhile, we might be poised to having to relearn our own history lessons.

Click here for complete article (and single page version).

Do fat people have fat germs?

The Washington Post reported “a startling discovery that could lead to new ways to fight the obesity epidemic.” The Associated Press suggested: “Maybe it’s germs that are making you fat.” A Nature magazine Op-ed written by Matej Bajzer and Randy J. Seeley of the University of Cincinnati said: “This is a potentially revolutionary idea that could change our views of what causes obesity and how we depend on the bacteria that inhabit our gut.” And Jeffrey Gordon of Gordeon Lab, recently renamed the Center for Genome Sciences, at Washington University in St. Louis said: “For the first time, we see that there is a correlation between the microbial gut ecology and the obese state...That’s part of the pathology of obesity.”

Now, before you think that science has shown fat to be indicative of yet another diseased state, or that popping microbe-containing pills or special “probiotic” foods will make you slim, or that you might “catch” obesity, you’ll want to know what the research being reported actually found.

These news stories were based on a nine paragraph “Brief Communication” in this month’s Nature magazine. Researchers at Gordeon Lab wrote that when they tested the stool of ten people, the bacterial flora were different after the people had been dieting for a year and had lost weight, than their flora were before starting their diets. Of the trillions of bacteria and other minute bugs in the intestinal track that helps break down food and fight off infections, the proportions of two groups of bacteria, Firmicutes and Bacteroidetes, had changed after dieting. Bacteroidetes had increased from 3% to nearly 15% of the gut bacteria. So the people’s flora while they were fat were different than when they were thinner. It was also different from 5 thin people, although when asked, the researchers didn’t reveal the dieting status of these thin counterparts.

In their paper, the researchers concluded that this association between body weight and bacterial flora “indicates that manipulation of gut microbial communities could be another approach in the treatment of obesity.” They speculated that perhaps the bacteria were able to extract more energy from food, causing obesity, althought they didn’t know how many calories the microbes might account for and admitted it would be small.

Professor Boyd Swinburn, president of the Australian Society for the Study of Obesity in Melbourne, pointed out what is probably clear to you, too. This correlation between body weight and bacterial counts does not mean the bacteria caused the change in body weights, or caused obesity in the first place. “I think it’s totally wrong,” Professor Swinburn told the Australian News. “Gordon’s group showed only that dieting changed the balance of gut bugs, not the opposite as they claimed.”

The Center for Genome Sciences researchers will continue their Human Genome Project under a $1.45 million grant from W.M. Keck Foundation awarded them in February, 2005 to “develop new approaches to isolating, sequencing and analyzing the genomes of friendly bacteria that inhabit the intestine and identifying the natural metabolic products that they synthesize.”

Click here for complete article (and single page version).

The green slim diet regimen

The green slim being poured into glasses in this story’s lead photo is probably enough to make most people doubt the wisdom of this diet! But good science also cast doubts on detox diets and the fears behind them.

In Pursuit of a Body That’s Pure

...A spa where the rich and beautiful flock to purify their bodies of the chemical excesses of 21st-century existence. “Between the stresses of everyday life (deadlines, relationship struggles, traffic) and the impurities found in processed foods, the body is full of toxins and the mind, tension,” declares the Website... Guests go without solid food for anywhere from three to eight days, subsisting on a liquid diet that supposedly helps flush their systems of pollutants and preservatives while still providing vital nutrients.

They gulp down 14 individually formulated drinks daily to boost their energy and loosen stuck matter in their colons. They imbibe endless cups of fresh vegetable juice, gallons of blood-purifying tea and enough water to grow a tree in the desert. Then, packed to the gills with fiber and herbal laxatives, they receive colonics, lymphatic massages and Korean skin scrubs to help flush the toxins....these enthusiasts hope to purge themselves of accumulated metabolic waste and man-made poisons....

Most people who do detox regimens speak of them with the zeal of religious converts. They can’t wait to detox again. But medical professionals urge caution. They say detox diets can be extreme and potentially dangerous. They also say there’s no evidence that these diets do any good.

“The idea that foods are poisonous, or that we need detoxification, or a cleansing regimen to improve our health is without scientific merit,” says Roger Clemens, a nutritional biochemist at the School of Pharmacy at the University of Southern California. “We have wonderful organs, great enzymes, a great system for eliminating toxins naturally.”

...Detoxing is based on the idea that people take in or absorb toxic chemicals such as pesticides, mercury, dioxins, polychlorinated biphenyls (PCBs) and food additives through the food they eat, air they breathe and water they drink. When these chemicals build up to a certain level, the theory further goes, they can overpower the body’s natural detoxification system — causing fatigue, mental sluggishness and various “allergy-like symptoms.”

...Claims vary depending on the diet, but testimonials generally suggest that these regimens will boost energy, increase mental clarity and make skin glow.

Such diets seem to resonate with an often-affluent urban psyche that seeks to cure all through health and nutrition, and to fit neatly into this age of instant gratification and pervasive fears about environmental pollution.

...In fact, most scientists say there is no evidence to support the notion that these often extreme cleansing methods do anything except perhaps dehydrate you and throw off your electrolyte balance. When people do the regimens to excess, they can get muscle cramps or pass out, sometimes even push their kidneys to begin to shut down. “It is fraud,” Cedar-Sinai’s Pressman says. “It is a distortion and misapplication of science and medicine. Kidneys and livers don’t need rest. They don’t need water in huge quantities. What they need is to be used. Our body’s own capacity to detoxify itself is beyond anything we can design.”

Susana Belen, the 68-year-old founder of [the] Spa, is not swayed by the lack of science. “Just because it hasn’t been scientifically certified does not mean benefits do not exist.... One woman bounces on a tiny trampoline in the shade. She’s preparing for her colonic: five minutes of jumping to loosen things up. “I think the body stores toxins up in the body. It gets clogged...And here, you can get that out.”

Click here for complete article (and single page version).

Medical record privacy update

Health Care Renewal just reported on “Another Electronic Medical Record Horror Story.”

According to a Wall Street Journal article, medical information about her psychotherapy that patient, Patricia Galvin thought was confidential was released to an insurance company. Health Care Renewal writes:

[C]omplaints to HHS about breaches of medical privacy have exceeded 23,000 [and] HHS presently receives about 700 new complaints monthly, while enforcement of "guarantees" such as in the HIPAA act are basically non-existent. I'd bet a large proportion of these breaches were facilitated by electronic legerdemain.

Ms. Galvin’s fears that her most private thoughts and secrets are “mere data of a transaction, like a grocery receipt” are well-founded and truly give life to an observation I made several years ago while leading electronic medical records (EMR) implementation at a large hospital....Unfortunately, as Ms. Galvin discovered to her horror, good things do not come from treating twenty-first century medical “transactions” as nineteenth century accounting data.

We’re not alone in the United States. In the UK, the ambitious Connecting for Health national EMR project and plans for a central clinical database have been met with stiff resistance from patient advocacy groups. Plans to upload medical records onto the central clinical database will put patient confidentiality at risk, the UK program has been told by its own consultants....

A similar advocacy movement is needed in the U.S., for there has been an idealistic and almost reckless push in the US to put any and all healthcare information into EMR’s and other electronic databases, even when the financial and clinical benefits are unproven....

In a decade when conflict of interest and mismanagement in healthcare is common, break-ins to supposedly secure databases appear in the news almost weekly, and dominant computer operating systems are barely able to keep ahead of hackers’ attempts to circumvent security, the dream of patient confidentiality is increasingly utopian. The reality is that the HIPAA act lacks teeth, enforcement initiatives non-existent (as the Journal reports), and stated exceptions to the HIPAA rules are prone to misuse by the powerful and those with financial incentives. These factors make it likely that the HIPAA “guarantees” are not worth the weight of the paper they’re written on.

In reality, if you want to keep information secure, don’t put it on a computer; and if you have to put it on a computer, and the computer is to be put on a network, then the information by definition is no longer secure.

These harsh realities call for a critical rethinking of the types of clinical data that should be put into electronic databases, and on governance of privacy, security and confidentiality....

Healthcare professionals quickly come to know that patients’ records are not really confidential, but when they become electronic, the numbers of people and interests with potential access explodes. The public would be astounded to learn that HIPAA gives virtually anyone remotely connected to their healthcare, third-party reimbursement or regulatory surveillance, access to their most private information, as explained by Patient Privacy Rights Foundation (and was recently written about here).

Given the unsoundness, conflicts of interest and potential for misuse of employer, government and health insurer clinical guidelines, health screenings, “health risk assessments” and “wellness” programs (as written here), the public would be wise to avoid volunteering information about their private lives to their employer or insurer. But many do, lulled perhaps by assurances the information they provide is “confidential” and will help them, and that their privacy is protected under HIPAA.

In a related story, the Chicago Sun Times just reported on an online Personal Health Records database being created by one of the country’s largest health management companies, Blue Cross and Blue Shield Association, which has partnered with America’s Health Insurance Plans, the main lobbying organization for 1,300 health insurance companies. The newspaper reports:

The two groups have developed and pilot tested standards on what should be included in the records and that make them portable, enabling consumers to transfer the records when they change insurers or doctors.

The groups, whose members cover more than 200 million people, said the goal is to have insurers include in every personal health record core data such as records of visits to doctors' offices and hospitals; medical conditions and illnesses; treatment plans, including medications; immunizations; allergies; health risks, and health insurance information....

An estimated 70 million people have personal health records through their health insurers, and millions more are scheduled for the service next year, the groups note. But, until now, the information contained in them has been inconsistent. Physician groups have urged the industry to work to standardize the information....

Association spokesman John Parker, said, "There could be many different bells and whistles to distinguish [the records] in a unique way, but core elements would be shared."

Patient Privacy Rights, a national consumer watchdog organization based in Austin, Texas, denounced this plan. “This is a wolf in sheep’s clothing,” said Deborah Peel, MD, founder and chair of Patient Privacy Rights. “Insurer-provided electronic personal health records held in a data bank that the insurers control will be used primarily to benefit insurers, not patients.” Her organization reports that insurers will get:

· An immensely lucrative database they control completely.

· A rich compilation of patient data with no state or federal laws to prevent them from using the information any way they please.

· The opportunity to data mine the new information consumers add to their PHRs for medical underwriting.

· A great new business opportunity they can sell the PHR data of millions of enrollees to employers, drug companies, and data brokers.

“The last place on Earth where patients want to keep their complete medical records is in the hands of their insurers. But that is exactly what AHIP and BCBSA are proposing. By giving plan enrollees a Personal Health Record and asking them to fill in the blanks, we’re basically being asked to spy on ourselves for the financial benefit of the insurance industry,” said Dr. Peel. “Will these companies guarantee that patients’ personal health information will never be used against them or disclosed without informed consent?”

In a press release, Patient Privacy Rights described the research showing consumers do not want their insurers to have their complete electronic medical records and feel the privacy risks outweight any benefits. They “strongly advise all Americans not to participate in any personal health record databases or data banks until Congress passes a law saying that consumers own their health records and gives them the right to control who can access their health records.”

Also in electronic medical record news, National Business Group on Health founding board member, Thomson Medstat, was just awarded a three-year $14.9 million contract to build and support the Healthcare Cost and Utilization Project (HCUP) databases of patient- healthcare information (written about here). It will be the largest and most complex electronic database to date. The contract is from the Agency for Healthcare Quality and Research under the U.S. Department of Health and Human Services. Medstat is part of Thomson Corporation, which provides electronic software and applications, including business intelligence and decision solutions, “to help employers, government agencies, health plans, hospitals and pharmaceutical companies manage the cost and quality of healthcare,” according to their press release.

Click here for complete article (and single page version).

The fabled links between weight and prostate cancer

The media is getting a jump start on the traditional New Year’s kick-off to the dieting season. News reports are telling men that losing weight can lower their risk for prostate cancer. “Here's another reason for men to avoid packing on extra pounds over the holidays,” according to the Associated Press.

“This study is the first to link weight loss to a reduced risk of this disease...and adds to increasing evidence of the importance of maintaining a healthy weight throughout adult life,” said the American Cancer Society.

The study behind these news stories was by researchers with the American Cancer Society and Duke University School of Medicine who examined data on 5,232 men diagnosed with prostate cancer between 1992 and June 20, 2003. They were looking for associations between prostate cancer and weight status.

Oh, you heard it was a study of nearly 70,000 men? That’s the Trojan Number — named after the mythical ploy of the Greeks who infiltrated the city of Troy inside a giant wooden horse. As Dr. John Brignell, author of Sorry, Wrong Number! explains, it’s one of the strategies used by researchers to inflate the size of a study so it sounds more impressive when the actual number of people with the condition being studied is significantly less. In this case, only 7% of the men actually had prostate cancer and the remaining 64,759 men were “mere bystanders.” When you find a Trojan Number, cautions Dr. Brignell, “these studies are often part of a large data dredge, in which many combinations of condition and potential cause are covered, so that the inevitable coincidental excesses can be identified and claimed as significant.”

In this case, the data was culled from the Cancer Prevention Study II Nutrition Cohort, a subgroup of the Cancer Prevention Study II. This controversial database on 1.2 million Americans was created by American Cancer Society volunteers who recruited friends, neighbors and family members to complete lifestyle questionnaires in 1982. Another questionnaire asking them their height, weight, diet, and lifestyle factors was mailed to more than 84,000 men and 97,000 women living in states with cancer registries in 1992, when they were enrolled in this subgroup.

The actual findings of this study were decidedly different from what we’re hearing:

The researchers found no association between the men’s body mass index (BMI), or the men’s change in weight, and their overall risk for prostate cancer.

In fact, looking at the data, the obese men had about 10% lower overall incidence of prostate cancers and the risk steadily dropped as BMIs increased.

These held true even after the researchers tried in their statistical analyses to control for a number of differences between the "obese" men and “normal” weight men that could point to other possible factors:

·Black men were two times more likely to be obese than slim. (African Americans have a two-fold higher mortality rate from prostate cancers than white men, according to the U.S. Preventive Services Task Force.)

·Former smokers were 24% more likely to be obese than slim.

·The obese men in this cohort exercised 4 times less than the thinner men.

Most prostate cancers do not kill men diagnosed with them — while American men have a 15% lifetime risk of being diagnosed with prostate cancer, they have only a 3% lifetime risk of dying from the disease and 90% of deaths are in men over 65 years of age, according to the USPSTF. Most of the men in this study, about 90%, had PSA screening tests which can detect cancers four or more years before they would be picked up symptomatically. According to the USPSTF’s review of the medical evidence, “screening may detect cancers that appear clinically significant based on size and tumor grade, but which would not have progressed to clinical symptoms during the patient’s lifetime.”

Closely conforming to these facts, only about 5% of the prostate cancers in this study were metastatic, fatal cancers; 80% were nonmetastatic, low-grade. The remaining 662 cases were nonmetastatic high grade cancers, which they called “aggressive.”

If being fat played a role in prostate cancers, as is being suggested, risks should increase as body weights increase. They don’t. Even risks for metastatic and the nonmetastatic high grade cancers did not increase with increasing body weights. In fact, all of the statistically-derived relative risk numbers for associations between prostate cancers and body weight were so nominal they have no practical relevance. [See Have your steak and enjoy it too! for an explanation of tenable relative risks.]

With that caveat in mind, even the trivial changes in relative risks (remember these numbers are not a man’s actual risk, it is the percentage change of their actual 3% lifetime risk) reported in this study show that being fat is irrelevant and losing weight is unwarranted.

The news focused on the higher risk among “obese” men as compared to “normal” weight men for “aggressive” forms of prostate cancers, so let’s look at those numbers. There was no correlation with body weights. The 17% increased relative risk for “obese” men was actually lower than less heavy men in the “overweight” category with BMIs 27.5 to 30. And the slightly “overweight” men with BMIs of 25 to 27.5 had a 13% lower risk than the “normal” weight men!

And losing weight was even less related to lower risks for prostate cancers. The men losing 11 or more pounds had a 10% lower risk — and losing more (> 21 pounds) didn’t reduce their risks any further. That was the same reduced risk seen in men gaining more than 21 pounds! There were no differences in risks among the men who’d gained 6 to 20 pounds, were weight stable, or who’d lost 6-10 pounds.

And while the news accurately reported that the men who lost 6 to 20 pounds was associated with a 17% lower risk for the most deadly, metastatic forms of cancer — what wasn’t reported is that the men who gained 10 pounds had a 20% lower risk! And the men were gained 20 pounds still had a lower risk than the men who had "watched their weight" and not gained an ounce.

But this study’s findings are not surprising in light of the body of evidence, especially the evidence on real people. Any lingering concerns that being fat could increase risks for prostate cancer will be allayed by simply looking at the latest cancer statistics from the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Cancer Institute, and the Surveillance, Epidemiology, and End Results Program. While obesity rates are apparently rising, prostate cancer deaths have dramatically dropped over the past ten years by one-third.

So, this study actually provided no evidence for any of the things being attributed to it: It didn’t show that being fat raised a man’s risk for prostate cancer. It didn’t show that losing weight lowered a man’s risk for prostate cancer. It didn’t show that maintaining a “healthy” weight imparted any benefits. You may be surprised by how radically different the actual findings in this study are from the spin and speculations coming from the American Cancer Society. But those familiar with this special interest group and its history of going to any length to hype obesity fears won’t be. Its corporate sponsors include the largest pharmaceutical companies with drugs for weight loss and treating “obesity-related” conditions. And Weight Watchers is the founding sponsor of the American Cancer Society’s annual Great American Weigh-In held in cities across the nation, “whose primary goal is," according to WW, "to make people aware of the link between being overweight and the risk for many diseases, especially several forms of cancer.”

© Sandy Szwarc 2006

Click here for complete article (and single page version).

There's more to childhood

Another parental call for sanity by Jose Appleton:

There’s more to childhood than counting calories

The obsession with expanding waistlines is narrowing horizons for children — and replacing adult guidance with health tips. Politicians, companies and charities are lining up together in the trenches in the war against childhood obesity....

Increasingly everything that children do is assessed with reference to body mass index...Good now equals active, low fat, and smaller waistline; bad equals inactive, full-fat and bulging belly.

Childhood obesity has become the bottom line justification for children’s activity....The need to combat obesity apparently also means that they should eat good food, and eat with their family at mealtimes. This signifies a profound narrowing of vision....Children’s activity is judged in terms of narrow goals and ends, the numbers of calories that it burns, rather than being seen as simply a normal party of everyday life, or as useful as an end in itself....

Increasingly children are encouraged to engage in ‘active lifestyle programmes’. The Department of Heath gave some children pedometers to measure the numbers of steps that they take in a day. Schoolchildren in Denver received similar pedometers back in 2002, and have been counting their steps ever since. Experts try to work out what is an acceptable pedometer reading....In Minnesota, an obesity researcher designed a classroom that encouraged children to fidget.... The children are adorned with sensors to measure their every movement....

Although obesity is now the number one sin with which to scare children, it’s seen in peculiarly pragmatic terms. There is an obsession with measurement....Researchers are busily working out all the various ‘factors’ that influence childhood obesity....

These policies are in danger of breeding a new nation of self-obsessed gym goers, who are forever counting their steps and calorie intake. Kids shouldn’t be thinking about their weight, even - or perhaps especially - if they are fat...

There is more to childhood than not being fat....

Click here for complete article (and single page version).

Merry Christmas!

Whatever holiday you are celebrating this winter season, I hope it finds you surrounded by love, laughter and lots of wonderful things to eat. Safe travels to all of those traveling over the river and through the woods to visit loved ones.

Some accuse Santa of being a bad role model because he’s fat, 350 pounds by some estimates. He’s a fine role model: he’s friendly, kind, generous, makes people happy everywhere he goes, and is a brilliant scientist and project manager. How else could he figure out how to travel 1,000 miles per second to deliver a gift to every one of the 775 million children celebrating Christmas? And that’s after coordinating the elves to make the toys and wrap them all, using 650,000 miles of wrapping paper, according to Carnegie Mellon University. And Santa is in terrific shape. The Pittsburgh Tribune Review reports today that Santa will burn 52 billion calories just climbing chimneys tonight. That’s quite a workout. In fact, his doctor is probably worrying he’s overdoing this exercise thing. He’ll need all of those holiday cookies and glasses of milk to keep up his energy. And despite loving holiday goodies, he is living to a ripe old age of several thousand years, I hear, although I couldn’t find evidence to confirm that. :)

Click here for complete article (and single page version).

“Science” works on Christmas Eve to track Santa

Since it’s Christmastime, we’re taking a departure from serious topics to something fun to share with your little ones. Of course, this information will also help you have Santa’s cookies and milk ready for his arrival! :)

In 1958, Canada and the United States created a bi-national air defense command for the North American continent called the North American Air Defense Command (NORAD). Since then, NORAD has used four high-tech systems — radar, satellites, Santa Cams and jet fighter aircraft — to track Santa travels as he delivers gifts to boys and girls around the world. Hundreds of volunteers spend part of their Christmas Eve at the Santa Tracking Operations Center at Peterson Air Force Base in Colorado taking calls and emails from children around the world and providing them with up-to-the-minute information on Santa’s whereabouts.

Kids can track Santa online at the NORAD website: http://www.noradsanta.org or call NORAD at 877/446-6723. The information is available in six languages.

According to NORAD, their radar system is called the North Warning System. It is especially powerful and has 47 installations across the northern border of North America, all checking closely for signs Santa Claus is leaving the North Pole on Christmas Eve.

The moment our radar tells us that Santa has lifted off, we use our second mode of detection, the same satellites that we use in providing warning of possible missile launches aimed at North America. These satellites are located in a geo-synchronous orbit (that's a cool phrase meaning that the satellite is always fixed over the same spot on the Earth) at 22,300 miles above the Earth. The satellites have infrared sensors, meaning they can detect heat. When a rocket or missile is launched, a tremendous amount of heat is produced - enough for the satellites to detect. Rudolph's nose gives off an infrared signature similar to a missile launch. The satellites can detect Rudolph's bright red nose with practically no problem. With so many years of experience, NORAD has become good at tracking aircraft entering North America, detecting worldwide missile launches and tracking the progress of Santa, thanks to Rudolph.

The third detection system we use is the Santa Cam. We began using it in 1998 - the year we put our Santa Tracking program on the Internet. NORAD Santa Cams are ultra-cool high-tech high-speed digital cameras that are pre-positioned at many places around the world. NORAD only uses these cameras once a year - Christmas Eve. The cameras capture images of Santa and the Reindeer as they make their journey around the world. We immediately download the images on to our web site for people around the world to see. Santa Cams produce both video and still images.

The fourth detection system we use is the NORAD jet fighter. Canadian NORAD fighter pilots, flying the CF-18, take off out of Newfoundland to intercept and welcome Santa to North America. Then at numerous locations in Canada other CF-18 fighter pilots escort Santa. While in the United States, American NORAD fighter pilots in either the F-15 or F-16 get the thrill of flying with Santa and the famous Reindeer Dasher, Dancer, Prancer, Vixen, Comet, Cupid, Donner, Blitzen and Rudolph. About a dozen NORAD fighters in Canada and the United States are equipped with Santa Cams.

Click here for complete article (and single page version).

Eat, drink and be merry!

It is nearly impossible to find that sentiment in the media today. It’s all about eat, drink and be ... moderate, healthy, watch what you eat and stick to your diet. Humbug! In the Telegraph, Tom Hodgkinson asks ‘what’s stopping us from being merry’?

What does ‘merry’ mean? It’s a word that, these days, is used only in conjunction with Christmas or to describe Robin Hood’s men. We have a vague notion that being merry is something to do with the red beaming face of Father Christmas and hearty laughter, but otherwise the idea of merriment seems an archaic irrelevance.

The word ‘merry’ actually captures an old-fashioned, fun-loving, medieval approach to life, and it’s a word and a concept that we might do well to resurrect in these grey bureaucratic days. The word reminds us that, in the Middle Ages, the light-hearted inhabitants of ‘Merry England’ really did think it was important to have fun and to limit the amount of work we did.

In the old days,Christmas lasted a full 12 days, during which time you were not allowed to work. It was a whole 12 days given over to feasting and having fun. And the fun and indulgence were not indulged in guilty fashion, as is the case today.

The medieval merry-makers did not admonish themselves when the party was over and condemn themselves to self-torturing diets and new schemes for an improved life. On the contrary, to be merry was practically a social duty. Merriment was built into the ethical codes of the time. And the Church itself actually encouraged merriment, drinking and conviviality – not just at Christmas, but all year round.

Why was it so important to be merry for medieval England? According to Professor Ronald Hutton, of Bristol University, the big difference in the medieval approach to life was that they were intensely community-minded. ‘The medieval emphasis on community meant that there was a need to cultivate virtues that made communal life better,’ says Hutton. ‘Merriment, which we would today call conviviality, was one of these.’

And rather in the same way that Robin Hood’s outlawism was intimately bound up with his detached, devil-may-care attitude to life, the Christmas festival was a time when we could release our wild sides. The writer Jay Griffiths argues that the drunken Oxford Street reveller, clutching the lamppost, his reindeer antlers hanging on his head at a skewed angle, represents the real Christmas spirit: ‘The spirit of Christmas is not restrained or well-heeled, but excessive and vulgar in its original sense: of the common people.’

Christmas is therefore anti-authoritarian, and its real purpose is not so much to sit piously and remember the birth of Christ, but to dance and sing and drink ale and spiced wine to excess. The medieval spirit and the spirit of Christmas were about taking your pleasures now and damn the consequences. ‘Eat, drink and be merry, for tomorrow we may die,’ was the line from Ecclesiasticus that was used to give biblical approval to living in the moment....

The rest of his article is here.

Click here for complete article (and single page version).

Mythinformation

The Philadelphia Inquirer reports:

Myths about health and holidays abound

There are more health-related myths about the holiday season than about any other time of year. We just made that up, but it has the kernel of reasonableness that helps such untruths endure. After all, the holidays coincide with that other font of mythinformation — the cold and flu season....

1. Americans gain several pounds over the holidays

Not true - or at least it wasn't six years ago. The average weight gain between Thanksgiving and New Year's was less than a pound, based on a study of 195 adults who were repeatedly weighed from September to mid-January by researchers at the National Institutes of Health.

It has been confirmed, however, that Americans think they gain more. In a 2004 survey of 1,000 adults by the Kaiser Permanente health plan, 43 percent of men and 49 percent of women said they tended to gain "a few pounds" during the holiday season....

Throughout time, the body weights of humans have had natural seasonal fluctuations, gaining a little during the winter which comes off naturally during the summer. And overall, we naturally get a bit larger with age, all without us having much say in the matter. A quarter of a century ago in The Dieter’s Dilemma, William Bennett, MD and Joel Gurin documented that our bodies’ natural setpoints are maintained within a genetically-determined range. Dieting and controlled eating isn’t going to change that in the long-run. Research has continued to show us that. Our body types and the amount of fat our bodies carry “is automatically regulated and some people are naturally fatter than others,” they wrote. “It is a biological fact of life, an aspect of the human species’ inherent variability.”

All of the hand wringing over holiday weight gain and the need to count calories and watch what we eat isn’t grounded in good science. “The standard, ‘sensible’ recommendations to change eating habits and diligently use calorie charts are also no more than elaborate folklore, expressions of faith in a world that ought to exist, but in fact does not,” said Bennett and Gurin.

Click here for complete article (and single page version).

Fear is terribly catching, bird flu isn’t

Fears of another impending health crisis were accentuated today as news stories threaten “Flu virus could kill 81 million.”

These latest death threat statistics, reported from the same press release, appear to have been created for the greatest scare value, according to Steve Milloy. In a Fox News article, he reviewed the flaws in how those numbers were derived, along with some valuable cautionary science:

...First, the researchers’ estimate of 62 million deaths has far more shock-value than credibility....The 62 million-death sound-bite is the product of statistical modeling that uses worst-case death rate estimates from the 1918-1920 pandemic influenza – an epidemic that medical historians believe killed somewhere between 20 million to 100 million people.

[T]he researchers ignored several key (not to mention glaring) differences between 1918 and 2006. First...modern medical care and public health practices have dramatically improved since 1918. So any flu epidemic is likely to be far less severe....Next, a great proportion of the deaths in 1918 was probably due to secondary bacterial infections that followed the initial viral infections. Today, antibiotics would be used to treat bacterial infections.

And let’s not forget that during 1918-1920, much of the world was still recovering from the strains of World War I. Poverty, hunger, unsanitary living conditions and stress likely made much of the global population ripe for a killer flu pandemic.

None of these considerations were factored into the researchers’ estimate.

But perhaps the researchers’ choice that most reveals their apparent desire to come up with a scary – rather than a realistic – death toll from pandemic flu is their decision to use the 1918 pandemic flu data in the first place. There were, after all, two other more recent and, in all likelihood, more relevant pandemic flu outbreaks in the 20th century....

While scares about a global bird flu pandemic have been brewing for years, the “shock we are seeing is way out of proportion to the risk,” said Anni McLeod, a senior officer of livestock policy for the U.N. Food and Agriculture Organization. “Consumers are not very much at risk from this disease,” she said at a World Poultry conference in May.

Infectious disease and agricultural scientists have been presenting science that tempers concerns for years, but it’s been underplayed in the media. Fostering fears of a crisis is too irresistible for a host of interests, from public health officials creating new emergency management programs, activists trying to frighten consumers away from animal products and modern farming, pharmaceutical companies and researchers seeking funding for vaccines, and media garnering readership and viewers with sensational headlines.

We rely upon our public health agencies to have prudent precautions in place to detect and prevent the spread of public health disasters and protect us from bioterrorism and other threats to us, which we also hope are based on objective risk analyses. But the calm, careful statements of the evidence are not reflected in the messages most consumers are hearing or the responses they are seeing.

American Council on Science and Health president Dr. Elizabeth Whelan said “given what history teaches us about the potential magnitude of such a pandemic...this is one case where the consequences might be devastating enough to make a heavy investment now reasonable.”

Congress allocated $3.8 billion last year to create a massive governmental bureaucracy to address avian bird flu under the Department of Health and Human Services and asked all state and local health departments to develop pandemic plans. According to the HHS, “the Homeland Security Department will be in charge of a national response to a possible bird flu pandemic, relying on the department’s National Response Plan and National Incident Management System.” The plan included forecasts of “a pandemic affecting 88 million people...with illness rates highest for school-age children... as many as 10 percent of all employees being unable to work...Prioritize the distribution of vaccines and antiviral medication... Calls for closure of schools, offices, and malls and possible communitywide quarantines in the event of a severe pandemic....” The government has ordered 2.7 million doses of flu vaccine from three pharmaceutical companies, enough to vaccinate first responders, although the drugs have not yet been approved.

When U.S. Centers for Disease Control and Prevention scientists presented the evidence showing limited transmissibility of the avian flu virus, CDC director Dr. Julie Gerberding cautioned that the data didn’t mean the virus might not develop into a pandemic strain. As Peggy Jordan, a New Mexico state coordinator told reporters, while “the avian flu virus has not mutated to humans yet, it is just a matter of time.”

A recent article published by the Organic Consumers Association cited an editorial concluding: “In view of the mortality of human influenza associated with this strain, the prospect of a worldwide pandemic is massively frightening.” It ended with the dire statement: “Humanity’s lust for flesh not only kills billions of animals every year directly, but threatens the health of our planet and may threaten our health in more ways than we know.”

Such terrifying claims certainly play on our emotions. But the value of exaggerating the dangers and scaring people half to death is questionable. Most consumers just want a balanced presentation of the facts. As in the case with so many scary things in the news today, the evidence and the work being done by capable scientists in this field offer reassurance, not fear.

Bird flu, avian influenza, is just that. An infection in birds which occurs naturally from flu viruses that have been recognized in poultry since 1901. There are two forms: “low” and “high” pathogenic. The low type can make birds sick but poses no serious threat to people, whereas the high type spreads more easily among birds and is often fatal to birds. The high pathogenic type, known as HPAI, can infect people after extensive contact with infected birds. Most consumers don’t know that HPAI has been detected three times in the United States — in 1924, 1988 and 2004 — but it never caused significant health problems for people, according to the U.S. Department of Agriculture. That’s because, like other veterinary issues, this disease was quickly eradicated as a result of close surveillance of bird populations (live bird markets, commercial flocks, backyard and small growers, and migratory bird populations); import restrictions; and coordination between USDA, state, local and industry which act quickly to prevent the spread and vaccinate healthy birds outside an infected area. But it is important to know that there is no evidence that the particular strain in Asia, Europe and Africa over recent years currently exists here in the United States and it is unlikely to be introduced, given the “multi-firewall” strategy in place.

According to the U.S. Department of Agriculture, the chance of infected poultry entering the processing system is extremely low. “Infected birds are typically too ill to be transported to processing plants. Federal veterinarians also check the health of all birds before they are processed to ensure that only healthy poultry enter the U.S. processing system.” American commercial poultry farms also prevent poultry from coming in contact with migratory wild birds that can introduce infections. While fears have raged that people can get bird flu from eating chicken and poultry, they are not based on the evidence. Simply using the same safe food handling and cooking that you use for poultry anyway is effective in destroying the virus, in the unlikely event it were to be present, says the USDA and CDC. You can enjoy your fried chicken or holiday turkey without fear.

Of course, the main concern is if bird virus could randomly mutate to become a flu dangerous to people. It would have to become more transmissible from birds to humans and more transmissible between people to create another pandemic. The evidence is showing that’s much less worrisome than we’re being led to believe. Recent CDC research, such as that published this summer in the Proceedings of the National Academy of Sciences, was unable to pass the virus that can cause human infections between birds, using the main pathways for transmissibility, “demonstrating that a pandemic may be harder to develop than originally thought.” They even tried unsuccessfully to make the viruses more transmissible by gene-altering them to cause mutations.

And in October, the CDC’s Emerging Infectious Diseases Journal published a study that investigated all the households within a 1 kilometer radius of the human cases of bird flu in Cambodia. They found that “even when human-poultry interactions were regular and intense” and where infected poultry outbreaks had been confirmed, the transmission of bird flu viruses to humans is low. They also learned that simple hygienic animal handling practices greatly reduced risks and pointed out that educating rural farmers about those might prove most beneficial. They noted that their findings were consistent with other studies since 2004.

People are not birds. “We are protected by a species barrier,” said Dr. Marc Siegel, associate professor of medicine at New York University School of Medicine and author of False Alarm: The Truth About the Epidemic of Fear. “Serological surveys conducted in 1997 in Hong Kong and since have detected antibodies in thousands of humans who never got sick, showing that bird flu isn’t as deadly to the few who come in contact with it as has been reported,” he said. Paul A. Offit, a virologist at the Children’s Hospital of Philadelphia, said that the evidence “should make us feel safe that there’s a substantial barrier.”

Two groups of researchers, in Japan and Holland, reported earlier this year that the while the avian flu virus can on rare occasions infect people, it’s not like other respiratory viruses. Avian flu viruses settle deep in the lower lungs, keeping them from being spread by coughing and sneezing. They don’t spread easily between people because they don’t infect the nose, sinuses and throat, meaning a flu pandemic is unlikely. “The avian virus would need to accumulate many mutations in its genetic material before it could become a pandemic strain,” said virologist Yoshihiro Kawaoka at the University of Wisconsin and the University of Tokyo.

The bottom line: While the word “pandemic” strikes fear in the hearts of most of us, we have also lived through a pandemic and were probably not even aware of it. The last flu pandemic was in 1968 and killed 33,800 Americans — about the number who die from the flu in an average year. There is no evidence we need to panic about another flu pandemic based on the millions who died a century ago. Flu is worthy of our attention and prudent precautions, but panic can be far more virulent and costly than the bird flu itself.

© Sandy Szwarc 2006

Click here for complete article (and single page version).

Fat people burdens on healthcare? Not so fast!

If we believe the news, “Hospital stays of obese Americans have doubled in the past decade, according to new federal data.”

This story and its corresponding press release are from a new report from the Healthcare Cost and Utilization Project (HCUP): Statistical Brief #20: Obese Patients n U.S. Hospitals, 2004. It is sponsored by the Agency for Healthcare Research and Quality (AHRQ), whose role it is to support government public health initiatives, including the war on obesity. [See The Scientific Evidence…]

According to its website, “HCUP databases bring together the data collection efforts of State data organizations, hospital associations, private data organizations, and the Federal government...[and] includes the largest collection of longitudinal hospital care data in the United States, with all-payer, encounter-level information beginning in 1988.”

First off, a note of caution. The HCUP report is not actually reporting hospital stays of obese people. It is a tally of the numbers of times “obesity” was checked off on the billing codes on the hospital records. These codes are currently known as ICD-9 codes, taken from the International Classification of Diseases, Ninth Revision. This is an enormous, complicated and continually changing system which gives a number to every disease and medical procedure, and currently has about 12,000 codes. The medical literature is filled with documentations of their inaccuracies in reflecting actual patient disease rates. But over recent years, healthcare providers are being increasingly educated on using these codes in order to receive reimbursements ... including coding for obesity. The weight loss and bariatric industry has been especially intense in marketing the usage of the obesity code, in particular.

Not surprisingly, more providers are.

So that 112% increase in hospitalizations for “obesity”since 1996 actually reflects increased usage of the coding, but whether or not it means there are actually more obese patients is arguable. But with the heightened stringency and surveillance by third party payers in compelling providers to accurately note ICD-9 codes in order to receive reimbursements, the current figures are certainly more complete than in past years.

This report is being presented as proof that “‘obesity’ has become a major public health problem.” That was even its opening sentence. But the media’s failure to give us the full story is demonstrated in the most significant fact in the report: 94.3% of all hospitalizations made no mention of obesity!

Fat people are not flooding into hospitals with health problems more than anyone else.

“Obesity” is the primary diagnosis in only 0.4% of all hospitalizations and virtually all of those (95%) were for bariatric surgery! Not the result of fat people succumbing to life-threatening health problems, but a profit-making elective surgery targeting them.

Interestingly, while fatness for women is especially benign, 82% of patients hospitalized for “obesity” and receiving bariatric surgeries were women, and most of those as healthy young adults (ages 18-44).

Concerning the rest of the story about hospitalized patients with “secondary diagnoses” of “obesity,” it goes without saying. With 30% of the population now labeled “obese,” considering all medical care done them as related to their weight is, frankly, nonsense.

© Sandy Szwarc 2006

Click here for complete article (and single page version).

A husband’s heartbreak

Sometimes those hurting the most from eating disorders are loved ones. The anguish in this husband’s blog post is hard to read. But it is important to read, just as is young Polly’s letter he shared in Along Came Polly.

With eating disorders, we most often think of young women who begin dieting typically in response to concerns over the natural weight gain that comes with growing up or their attempts to meet the unrealistically thin bodies they’ve come to believe are ideal. But eating disorders are also not uncommon among middle-age and older women and men. Many adult women have suffered from eating disorders for a decade or more.

The largest study on body image and eating disorders, published in Psychology Today, reported that even among “normal” weight women 30 to 74 years of age, 70% were unhappy with their weight; and that dissatisfaction with one’s body increases as women age.

Dr. Katherine Zerbe, M.D., at the psychiatry department of Oregon Health and Science University in Portland and author of The Body Betrayed, said that up to age 60, most women naturally gain 5-10 pounds per decade of life, usually accompanying developmental milestones such as puberty, pregnancy and menopause.

As their bodies undergo the normal changes that accompany aging or they develop concerns about their health, women can also find themselves confronting unrealistic expectations of thin, youthful bodies and begin dieting and exercising to extremes.dissatisfaction is

In November’s issue of the International Journal of Eating Disorders, Austrian researchers reported that among a random sample of 1,000 women in their 60s, more than 80% were controlling their weight, 90% said they felt fat and over 60% said they were unhappy with their bodies. Especially worrisome was that 4% met the diagnosis for eating disorders.

According to Dr. David Garner, Ph.D., director of River Centre Clinic in Sylvania, Ohio, and adjunct professor at Bowling Green State University and the University of Toledo, one of the most important advancements in the understanding of eating disorders is the recognition that it is severe and prolonged dietary restrictions that can lead to eating disorders and serious physical and psychological complications. As his research, and Ancel Key’s original starvation studies, has shown, hunger results in a host of symptoms — eating behaviors, physical and emotional changes, and social function — that are identical to those seen in eating disorders. According to Dr. Garner, many patients don’t understand that hunger and semistarvation explains many of the symptoms they are experiencing. He says they can be helped and be less likely to persist in blaming themselves, continue self-defeating dieting, and feeling defensive, if they are “made truly aware of the scientific evidence.”

The body of research has shown that restrained eating and dieting significantly precipitate eating disorders. It makes today’s “healthy eating” advice — to watch what we eat, control our portions, count calories, follow serving guidelines, eat more “good” foods, and eat less foods deemed “bad” for us — risky and unhelpful for the vast majority of the population already feeling their bodies are unsatisfactory.

Click here for complete article (and single page version).

Calling all skeptics!

The 50th Skeptic’s Circle is now up at Humbug!

This special issue is a tribute to Carl Sagan — a great science teacher and skeptic — on the 10th anniversary of his death. Each submission pays homage to a chapter of his famous book, The Demon Haunted World - Science as a Candle in the Dark. His book showed how science can help us not be fooled into believing things that aren’t true, shared the successes of science-based medicine, provided a fabulous baloney detection kit, discussed the flaws of stereotyping women as nonscience-minded or all scientists as nerds, and offered a chapter on the antiscience used to attempt to justify unsound claims.

According to Skeptic’s Circle, Junkfood Science’s article, Healing Water, could be straight out of Chapter 10, where Sagan encountered metaphysical believers who claimed their paradigms couldn’t be adequately researched using science.

There are terrific articles in this commemorative issue and as Theo at Humbug says, “unlike most pseudo sciences, this pseudo memorial/homage won’t cost you a penny.”

Click here for complete article (and single page version).

Junkfood Science has just turned one month old!

Thank you to everyone for your heartwarming letters of appreciation and encouragement. And I sincerely thank all of my old and new blogger friends whose support has helped nearly 13,000 visitors discover this blog and read 22,000 pages in its first month! Special thanks to Steve and Barry, as well as Trevor, Karen, Emily, John, Mike, Dick, Joycelyn, Jean, Dr. A, Laura, Dr. Stacey, Sydney, Jim, Dave, Jon and so many others!

It’s great to know that people really do crave information they aren’t getting in mainstream media. I hope this website continues to help you and your loved ones enjoy the very best health and happiness.

Here are some of your favorite posts:

We saw first hand that when good research debunks pop science or popular beliefs and agendas, the media and special interests flurry into action with stories attempting to confuse us, spin the science, or simply restate their beliefs more emphatically. That was most strikingly when the CDC reported that obesity was actually not a major cause of death and that being thin was more dangerous than being fat.

We saw just how powerful our minds can be. We read of wacky diet gimmicks that play on false hope, even using biomagnets and false memories. We learned about collective delusions and cases of mass hysteria, and about placebo and nocebo effects common in many of our beliefs about good and bad foods, alternative modalities and obesity.

Junkfood Science readers got the full story on the new miracle weight loss drug that no other media would publish. We learned that the evidence is a far cry from the marketing, although the efficacy and side effects appear to be concerning the FDA now, as well.

We read multiple studies disproving claims of special health benefits from vegies or anti-oxidants. We discovered they don’t have anti-aging benefits; help prevent heart disease, stroke, cancer or type 2 diabetes; or prevent vision problems or cognitive decline.

We learned the evidence does not support claims that sodas contribute to childhood obesity. We found juices and sweetened drinks do not make kids fat, and even that the kinds of milk children drink are not associated with their weights. Bottom line, kids naturally come in all shapes and sizes unrelated to their diets.

We looked into how media and researchers often distort information, bombard us with hypothetical dangers, and overstate risks to support popular beliefs and agendas.

We saw that the evidence shows that neither red meat nor any type of dietary fat is associated with breast cancer.

We discovered that the actual toxic environment today may be healthism, as a multitude of special interests get on the health bandwagon, eager to promote “healthy eating,” fitness and exercise to prevent “obesity.” And we seen how our children are unable to escape this national obsession from the age of 6 weeks. We read the evidence suggesting four times more children are being harmed by it than ever might be helped.

We read the powerful words of two beautiful women who exemplify body and size acceptance.

We learned that hunger and food insecurity in our country mean real suffering that’s more life threatening than having enough to eat.

We’ve examined the other side of well-meaning, but unsound childhood obesity initiatives, weighing of children, “healthy eating” messages and “healthy” school lunch agendas. Not only do they have no effect on “obesity” rates, but they have left most children and many adults fearing any fattening foods and equating healthy eating with dieting and eating low-calorie, low-fat foods. Such fears have even become deadly.

We learned that the evidence does not show our food to be less safe today.

We saw that the evidence does not support that being fat decreases our chances of living a long life.

We expanded our understanding of the scientific process and how it’s different from pop science and learned about meta-analyses and odds ratios.

We discovered countless “obesity paradoxes” showing that most fat people actually live longer than thin people and that being fat actually has health benefits!

We discovered that low-salt agendas are not evidence-based and might even be harmful for most of us.

We learned of a study showing that being fat does not increase risk for miscarriages.

We read of numerous examples of how the media’s depictions of thin bodies, promotion of “healthy eating” and fitness, scaremongering about junk food, and glamorizing unrealistically thin bodies are affecting young people.

We’ve seen the many faces of eating disorders in children as young as five, among bulimics, little boys, young dieters, among those over-exercising, and among those trying to eat healthy.

We learned how the internet is being used by special interests for marketing, even creating and infiltrating mock patient support groups, such as dieting and bariatric surgery groups, message boards and forums.

We learned how insurance providers and companies are collecting personal information and medical data into massive electronic databases and that HIPAA does not protect us from that information being used and disclosed without our consent.

We saw the distortions in research being used to scare women about the dangers of gaining weight between pregnancies and learned that fat has important benefits for promoting healthy pregnancies and fertility.

We learned that many of the compulsory “wellness programs” and healthy lifestyle initiatives being imposed on growing numbers of employees have not been shown to be effective, have no clinical evidence of health benefits, and have actually been shown to jeopardize health.

We saw how fears over hormones in milk are marketing efforts to take advantage of fears and are most hurting the poor, but are based on junk science.

We discovered surprising facts and rarely-mentioned dangers in homeopathic preparations and pondered their place in medicine.

If you’ve enjoyed these articles, please consider making a donation to Junkfood Science. Your support will help keep these stories coming!

Click here for complete article (and single page version).

Getting our goat

When overriding fears and unsound beliefs prevent us from benefiting from what the very best, most careful, proven science can offer us and our children, the results can be tragic.

Fears and bogus information spread by soundbytes much faster than the truth. It is so easy to drop fear bombs and in an instant scare people by suggestions, “what-ifs” and frightening anecdotes. But it takes considerably more effort to explain, teach and help people understand the complexities of a science or health issue, and use the scientific method to carefully examine the evidence to uncover its limitations and true efficacy.

Those who speak out against unsound fears and beliefs — be it the “epidemics” of “obesity” or diabetes, the dangers in our foods, the poisons of our world, alternative modalities, or the anti-immunization movement — are the real scientists and health professionals. They use objective, critical, thoughtful and careful analyses simply for the greater good to help people. And they often do so at great cost because they’re sure to receive vicious attacks from believers or those profiting off the beliefs

Two such professionals appeared on the web this week. Wallace Sampson, M.D., professor of Medicine at Stanford University and editor of The Scientific Review of Alternative Medicine, wrote an informed, well-argued, thoughtful and respectful series of replies to the inflammatory mail he’d received about his recent article on Medscape. In that article, he had discussed the sources of error behind many of the beliefs Westerners hold of the effectiveness in traditional Chinese medicine. His exemplary and tireless replies were published on Medscape and make for fascinating reading on how fears and mistaken beliefs influence us.

The second medical professional is Dr. Flea, a pediatrician who has begun a laudable online series on vaccinations. As Orac noted, as expected, “the antivax hordes have descended on his blog.”

Immunization scares are some of the most disheartening and frightening for doctors and nurses working with babies and children. I am old enough to remember the polio tragedies of half a century ago and went to school with kids who were paralyzed from polio or whose brothers and sisters had died from it. We almost never hear about polio anymore because of immunizations. As an old neonatal and pediatric nurse, I remember that in the 1970s, a germ called haemophilus used to kill about 1 in 20 children with meningitis and left 1 in 5 permanently disabled. Now, thanks to immunizations, most pediatricians and nurses haven’t even seen this disease, and parents don’t have to worry about it. But if we fail to understand history and appreciate the good that science and modern life has brought, we are apt to move backwards.

Vaccinations have reduced deaths and disabilities from infectious diseases by as much as 97%, according to the U.S. Centers for Disease Control and Prevention (CDC), and serious complications are very rare. Sure the road to the development of safe and effective immunizations has had some bumps along the way and there are rare problems still today, and it may not always be prudent to jump on every new development that comes along before it’s been proven. But fears can lead us to not hear the full story and fail to carefully balance those risks with the risks of not immunizing our children.

One of the most commonly-believed scares are that vaccines can cause autism, developmental problems or sudden infant death syndrome. The age at which infants and children are typically diagnosed with SIDS, developmental problems, and autism is also around the time they receive various immunizations, which leads to concerns of a possible connection. But carefully performed scientific studies have shown no relationship between routine childhood vaccines and autism, developmental problems or SIDS.

Another belief we often hear is that additives in vaccines, such as mercury-containing thimerosal, are dangerous. While the vaccines recommended for routine childhood immunizations have not contained thimerosal since 1999 (or insignificant trace amounts) simply to try and allay those popularized concerns, it is important for parents to realize that the form of mercury believed to be associated with neurological problems in toxic doses is not even the same form of mercury used in vaccines!

It might be easy to think we’re safe and don’t need vaccines anymore, but we forget that in other parts of the world outbreaks of polio, diphtheria, measles and whooping cough are still occurring. With more people traveling, it’s increasingly easy to import them along with our frequent-flyer miles. Dozens of measles cases are imported to the U.S. from abroad each year, threatening the health of unvaccinated children and others for whom the vaccine was not effective. Recently, we’ve had unvaccinated children in New Mexico come down with measles after visiting the Ukraine and a child die from whooping cough.

Lance Chilton, MD, professor of pediatrics at the University of New Mexico and an Albuquerque pediatrician for 31 years said, “each time immunization rates have dropped in developed countries, such as England, Sweden, Japan and the U.S., they’ve had a rapid and dramatic increase in disease and deaths.”

“Measles is highly contagious and kills 1 or 2 of every 1,000 American children who get the disease—and a much higher proportion in developing nations— and puts others at risk for pneumonia, meningitis, deafness, and liver cancer,” he said.

“Parents are asked to make many important and difficult decisions for their children’s health,” said Dr. Chilton. “But nothing we do is absolutely safe, and when parents ask me for proof about vaccine safety, I say, ‘Vaccines are among the most tested drugs we have. Yes, there are rare problems with vaccines, but you took a higher risk to drive here to the clinic today.’”

Click here for complete article (and single page version).

Junkfood Science Special: Healing water

© Sandy Szwarc 2006

Should the popularity, political expediency or profit potential of a medicine determine our support of it? That’s how a surprising number of our public health guidelines, regulations, health benefits, and even curriculums in medical and nursing schools are decided. Do we want to go to a healthcare provider whose advise and prescriptions for us are based on their popularity and ability to make extra money for them? Or do we want to trust that our provider is giving us honest advice and therapies with proven efficacy?

And as medical professionals, is it ethical to endorse and put credentials behind modalities that lack reproducible, clinical and scientific evidence — or even plausible, rational explanations in proven biophysical science — simply because patients may want them or offering them can bring in extra revenue? Or would that be taking advantage of people and betraying their trust?

These are dicey questions and confront all of us daily in mainstream medicine and public health. But complementary alternative medicines may most challenge us to think about them.

A recent story from Switzerland highlighted how we’re often led by popular beliefs rather than science when it comes to making health decisions. Homeopathy has been a hot button issue there, as supporters of alternative preparations try to force officials to pay for them under their country’s compulsory health insurance. Last year, after investigating the evidence, the interior ministry found homeopathy therapies “failed to meet the criteria on efficacy, suitability and cost-effectiveness” under their law. But the science proved no deterrent and supporters gathered signatures and petitions to force it to a popular vote giving, as SwissInfo reported, “rational voters a headache.” Health agencies around the world, from Ontario to Scotland are considering including homeopathy and other alternative modalities among recognized medical professional services.

Homeopathic products have become popular here in America, too, as sales have reached $400 million a year, according to Grant Ferrier, editor of Nutrition Business Journal. But a surprising number of people, both professionals and consumers, don’t understand what they are and only know what they’ve heard from friends or advertisements. The most common situation I encounter is that many people think they’re natural, holistic medications, and confuse them with herbs and supplements that may have some active ingredient. Even if you think you understand homeopathic preparations, the following information may come as a surprise.

What are homeopathic products?

Homeopathic preparations are made from a mineral or botanical, chosen based on the "law of similars,” which maintains that symptoms of a disease can be cured by exposures to something that causes similar symptoms in healthy people. [So, if caffeine causes a healthy person to keep wide awake, then someone having difficulty sleeping would be given caffeine.]

This substance is then diluted in 10 parts of water or alcohol, then diluted again, then again, and again.... Most homeopathic products sold today are one drop that’s been diluted 1,000,000,000,000,000,000,000,000,000,000 times. And some are such large numbers, the dilutions have 1500 zeros!

At that dilution, it is the equivalent of one grain of rice crushed and diluted in a sphere of water the size of the solar system and repeating that process 2 billion times, said James Randi at a 2001 lecture at Princeton.

The liquid has not even a molecule of the original substance left and no measurable active ingredient. “Even the most carefully distilled water is likely to have more molecules of contaminants than a homeopathic remedy has of its ingredient,” said Dr. Harriet Hall, M.D., medical advisor with the National Council Against Health Fraud.

Homeopaths claim, however, that the more dilute the remedy, the more powerful it is. It is believed to have a memory of the substance, which leaves a spirit-like essence that cures by reviving the body’s “vital force.”

While the core of homeopathy defies biological plausibility, belief in it is analogous to today’s popular beliefs over the dangers from infinitesimal traces of “chemicals” — in parts per BILLION — in our foods and environment. Organic foods have also grown in popularity over the past decade and by 2003 accounted for $20 billion in sales, according to the USDA Economic Research Service.

What leads us to believe that we can be healed and harmed in such implausible ways? Both are spurred by being bombarded by scares of our modern life and medicine. When faced with so much seeming uncertainty, it’s natural for people to want to take control over their lives and embrace the comfort that simple explanations provide, said Mahlon W. Wagner, Ph.D., psychology professor at State University of New York, Oswego.

Are homeopathic products regulated?

Homeopathic products are not regulated like mainstream (allopathic) medicines, nor do they have to undergo clinical trials and be shown safe or effective and meet U.S. Food and Drug Administration (FDA) approval. The FDA can, however, take action on illegal marketing claims and has found homeopathic products being illegally marketed for heart disease, kidney disorders, cancer and other serious conditions.

Weight loss is common promise of homeopathics. During 1988, the FDA took action against companies marketing diet patches with false claims that they could suppress appetite. The largest such company, Meditrend International of San Diego, instructed users to place 1 or 2 drops of a “homeopathic appetite control solution” on a patch and wear it all day affixed to an “acupuncture point” on the wrist to “bioelectrically” suppress the appetite control center of the brain.

The FDA forced Biological Homeopathic Industries (BHI) of Albuquerque, New Mexico to stop claiming homeopathics cure serious diseases including cancer and strokes, as they’d published in catalogs sent to 200,000 doctors nationwide. But, according to Dr. Stephen Barrett, M.D, its Physician’s Reference continued to recommend products to treat about 450 conditions, including heart failure, syphilis, kidney failure, blurred vision, cancer, angina, bacterial infections and paralysis. The FDA again issued warnings to BHI, this time for making claims its homeopathic cold product was “effective for mumps, whooping cough, chronic respiratory diseases, herpes zoster, all viral infections, and measles.” BHI also claimed that when combined with their other remedies, it was “effective against otitis, pleurisy, bronchitis or pneumonia, conjunctivitis and tracheitis,” said Dr. Barrett.

Do homeopathic products work?

Homeopathic followers often assert that these preparations defy modern testing or that there have been few tests on them. Both are false.

“Many providers of complementary and alternative medicine are convinced that their therapy defies the ‘straightjacket’ of reductionist research,” said a recent panel report from the Conference on Complementary and Alternative Medicine Research Methodology, National Institutes of Health. Supporters argue that alternative modalities are individualized, holistic, intuitive, etc, and call for a ‘paradigm shift’ in research.” However, the Panel concluded that these arguments are based on a series of misunderstandings and concerns can be resolved by properly designing the research, and that “if the aim is to test the effectiveness of complementary and alternative medicine, randomized controlled trials usually provide the least biased method for finding a reliable answer.”

As Steven Bratman, M.D., a national expert on the scientific evidence on alternative medicine and principle author of The Natural Pharmacist and other books, said:

I once took alternative medicine on faith. For decades, I practiced it on patients and myself and my family, and assumed that pretty much all of it worked. Then I learned about double-blind studies, and it was like a tornado blowing down a house of cards. I discovered that I, like most people who love alternative medicine, had made a huge (though understandable) mistake.

I had thought it was possible to know whether a treatment worked by trying it. I had also thought I could trust tradition, anecdote, and authority. I now see otherwise. The insights of the double-blind trial have cut through my wishful thinking and idealism, and turned me into a hard-nosed skeptic. Show me the double-blind studies, and I'll pay attention. Otherwise, so far as I'm concerned, it's little more than hot air.

It doesn’t matter if the treatment has a long history of traditional use — in medicine, tradition is very often dead wrong. It doesn’t matter if doctors or patients think it works — doctors and patients are almost sure to observe benefits even if the treatment used is fake.

But such awareness isn’t common. When presented with the evidence that contradicts something they believe, as did a recent 20/20 episode debunking homeopathic preparations, many people didn’t care. They’d seen good effects with their own eyes and believed they must work if millions of people swear by them.

Homeopathy has undergone more than 150 clinical trials and all of the careful, quality studies have failed to show that homeopathy has any value over a placebo. There are, of course, efforts to make findings appear controversial, and systematic reviewers often differ considerably, as German researchers noted in a 2003 Journal of the Royal Society of Medicine. But, “well-conducted clinical trials consistently yield the least promising results,” they concluded. Every careful examination of the few studies being used to claim homeopathy is effective reveals major flaws in the design such as nonrandomized and selected study groups, no placebo groups and nonblinding, insignificant relative risks, evaluations based on subjective symptoms, etc.

Dr. Matthias Egger and other researchers at the University of Bern conducted the largest study ever done on homeopathy which was published last year in Lancet. After carefully analyzing 110 clinical trials, they found that the effects from homeopathic treatments were due to placebo. “We’re not saying that homeopathy doesn’t work,” Egger told SwissInfo. “We’re just saying that the effects that people clearly experience are perhaps not due to the little white pills.”

Researchers at the Institut Gustave Roussy, Villejuif, France, reviewed 40 randomized trials that compared homeopathic treatments to standard treatments and concluded there is no evidence that homeopathic treatment has any more value than a placebo. More than a dozen similar analyses have come to the same conclusion: homeopathy does not perform any better than placebos.

“There is little doubt that some conditions are quite responsive to placebo treatment, such as menopausal hot flashes, symptoms of prostate enlargement, and many types of pain, said Dr. Bratman. “While it’s often reported that only 30% of people respond to placebo, this number has no foundation, and, in fact the response rate seen in some of the conditions I just listed reaches as high as 70%.”

Much of the perceived benefits of homeopathy, like many alternative modalities, are due to homeopaths spending time with patients, listening and giving assurances. “The homeopath is seen as a concerned and sympathetic health-care giver,” said Dr. Wagner. And with the dissatisfaction and distrust some consumers have developed of conventional medicine, or when patients are told that there is nothing wrong with them and they believe otherwise, they are drawn to the reassurance of a cure that homeopathy offers, he said.

As singer Karen Louise told the Daily Record today, she believes alternatives are essential for her chronic fatigue syndrome:

Doctors told me I was depressed and had a virus and to rest and that other than that I was fine. But I felt my life was awful and I couldn't live like that....She booked me an appointment at a homeopathic centre. I went with my mum and had a full on assessment and was told I had ME. It was an amazing moment to find out I really was ill. There was a relief at knowing there was something wrong with me, but also a horror....I know there is controversy surrounding [homeopathy], but if you have been there and they help you, you don’t care what people think.

Are homeopathic products safe and cost effect?

These statements have appeared on homeopathic labels:

“No side effects”

“Non-habit forming”

“In case of overdose, call your poison control center”

While the first two are certainly true, the third bit of advice is of doubtful necessity. :)

While the placebo effect can be powerful and clearly the remedies themselves are not likely to hurt people, the potential benefit of relieving short-term symptoms with placebos have to be weighed against the harm that can result from relying upon — and wasting money on — ineffective products.

The actual costs of these products are rarely a concern for most current users because repeated studies have shown that homeopathic products are most popular among those who are affluent, white, younger and elite in our society. These are the same groups more apt to seek remedies for subjective symptoms and able to spend more for foods and products perceived as healthy, noted a critical overview of the evidence on homeopathy in the 2003 Complementary and Alternative Medicine Series published by the Annals of Internal Medicine. Never mind that “there is a lack of conclusive evidence on the effectiveness of homeopathy for most conditions.”

But when the moneys come from limited healthcare resources that could be directed to medications that are proven to help, then the risks become more critical. One of the most serious potential side effects rarely mentioned when balancing risks and benefits is the delay in seeking care while pursuing modalities that don’t actually treat an organic disease.

Some of the most popular homeopathic products, which soared 44% in sales last year, are for infants to treat teething and colic. One study of two million people in Scotland, for example, found that children under 12 months were the most likely to be given homeopathic or herbal remedies, nearly 1 in 10 babies. Parents might waste critically important time while a serious medical reason for their baby’s crying and pain is overlooked.

It is also a concern when homeopaths lead people to believe they are sick or something is wrong with them, or give them medical diagnoses that can be treated with a natural remedy, of course. Especially worrisome is that “most homeopathic leaders preach against immunization,” said Dr. Steven Barrett. “Equally bad, a report on the National Center for Homeopathy’s 1997 Conference described how a homeopathic physician had suggested using homeopathic products to help prevent and treat coronary artery disease,” he said.

One of the most frighten and poignant examples of why healthcare professionals worry about homeopathics and what can happen when people fall prey to believing unsound modalities was illustrated in a recent article in the Kelowna Capital News (British Columbia). It recommended packing a homeopathic travel kit before traveling where risks of Botulism, Hepatitis, Norwalk virus and E-coli loom. The kit included “30 to 40 homeopathic remedies to protect against food poisoning, traumas, insect bites and fevers.” The homeopath advised readers of “some excellent homeopathic remedies also for Malaria...I would consider taking that before taking the pharmaceutical medicine Quinine which has some side effects that include rash, nausea, low blood glucose level, severe swelling of lips face or tongue and flushing to name a few. If you have made an appointment to have your travel vaccinations you may want to cancel it and do some more research before you commit...”

This is really not a frivolous issue. Science and medicine may not have all of the answers, but it can help us protect ourselves and others from beliefs and quackery that can prove costly, misleading and hurt people... when we take the time to understand and care.

Click here for complete article (and single page version).

Food fears most hurt the poor

© Sandy Szwarc 2006

A nonprofit organization for low-income citizens has called on the FDA to intervene against the deceptive marketing of certain food processors. They are concerned it is needlessly frightening poor people away from healthful and affordable foods.

According to the National Organization for African Americans in Housing, some milk processors are labeling their milk as “hormone-free” or “no rbST” milk when, in fact, it is no different from other milk that costs much less. These deceptive labels have raised unwarranted fears, said Kevin Marchman, NOAAH Board Secretary, and are generating undue confusion and anxiety. It is putting poor people into having to make a horrible choice: spend their limited resources for higher-priced milk they can ill-afford, or buy affordable milk they are being made to fear is less safe for their children.

While scares about hormones in milk have been circulating for more than a decade, it is nothing more than a marketing ploy, said Terry Etherton, professor and head of the animal nutrition department at Penn State University’s Department of Dairy and Animal Sciences. These “hormone-free” labels are not even driven by consumer demand, he noted, as few consumers even know or understand what bST is. “Unfortunately, there are those who seek to profit from what is nothing more than smoke and mirrors.”

“Authentic consumer demand is not driving things here,” said John Fetrow, professor of dairy production medicine at the College of Veterinary Medicine, University of Minnesota, in a September letter to Feedstuffs. He believed it to be a “deliberate marketing strategy:”

For perfume companies competing for a bit of people's disposable income, this is a pretty harmless game. With food, it is not. The truth is that milk from cows treated with rbST is the same as milk from cows not treated, but if you can create a fear in the public's mind that there is a dangerous difference, then you have a way to differentiate your product, capture market share and charge more for the same milk.

Other major food corporations, not to mention the organic food industry, have been using the power of first creating and then marketing "food fear" for some time.

Milk sold as “hormone-free” can make a producer an additional $2.20 per gallon, said Dennis Wolff, Pennsylvania Agriculture Secretary. What we oppose is that it is simply capitalizing on fear, he said at a recent meeting of Pennsylvania dairy farmers. Consumers are being manipulated by science-sounding scares, but there is no science to support any of the claims being made about hormones in our milk.

What is it that these agricultural scientists know that makes them so certain that there is nothing to fear from hormones in our milk?

The best explanations I’ve found is in a bST Fact Sheet published by the U. S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, written by Dr. David Barbano at the Department of Food Science at Cornell University. It carefully addresses each of the concerns circulating about bST.

First off, he explains that the safety of bST had been extensively tested prior to its FDA approval. Since then, it’s undergone reviews by expert health agencies around the world and repeatedly found to be safe and that the milk from cows given bST is indistinguishable from the milk from other cows.

bST is the abbreviation for bovine somatotropin, also called bovine growth hormone, which is a hormone produced naturally in the pituitary gland of cows and is used to control milk production. “The term rbST refers to bST that is produced using fermentation technology and injected into dairy cows to increase efficiency of milk production,” said Dr. Barbano.

Sadly, those trying to frighten consumers about bST know that the word “hormone” will bring to mind steroids, like sex hormones and cortisone. But there are two types of hormones: steroid and proteins. bST is a protein hormone and has no activity when it’s eaten because the body digests it just like any other protein. Insulin is another protein hormone that doesn’t do anything when it’s eaten, which is why insulin-dependent diabetics can’t take it in a pill, but have to get injections.

The second major point not clarified among those trying to scare people is that cow hormones are not people hormones, so even when they’re injected they have no influence on people. “There is no way on this green earth for rbST to have a biological effect on a human,” said Dr. Etherton.

After extensive testing to compare milk from cows that received bST and those that didn’t, it has been repeatedly confirmed that “there are no differences in nutrient content (i.e., fat, protein, calcium, vitamins, etc.) or sensory characteristics (flavor, color, etc.), said Dr. Barbano. “Milk from cows given supplemental bST contains no more bST than milk from cows not given the supplement.” Nor are the small differences in IGF-1 (growth factor) that some fear, notably different from the normal, natural variations that occur during a cow’s lactation period. But IGF-1 also isn’t a concern because it, too, is a protein hormone and digested just like any other protein in foods we eat.

There have been all sorts of claims about bST’s role in triggering infections among the cows, but scientists laid those concerns to rest years ago. The FDA held a special advisory panel hearing in March of 1993 which reviewed the extensive body of research and confirmed that the natural seasonal effects on mastititis was 9 times more significant than any possible role of bST. And anytime antibiotics are given to a cow for an infection, that cow’s milk is discarded until there are no traces of antibiotics in the milk.

Milk and dairy products are among the most tested and regulated foods in this country. Every tanker load of milk is strictly tested for antibiotics. In the extremely rare event that any milk tests positive, it is disposed of immediately, never reaching the food supply. Farmers are financially liable if antibiotics are found in the milk, so they take these regulations very seriously.

In September 2003, the FDA issued warning letters to four milk producers to remove “hormone-free” claims from their labels because they are false claims. As the FDA letters noted, “all milk contains naturally occurring hormones and milk cannot be processed in a manner that renders it free of hormones.” The FDA said milk producers have no basis for claiming that milk from untreated cows is safer, but that hasn’t stopped producers from doing so.

So when we are making milk choices for ourselves and our family, we now have information to make an informed choice. We know that our milk supply has never been safer and there is no credible evidence for concerns.

But there is a wider problem these scare campaigns bring that should concern us, said Dr. Fetrow. And that is, that they undermine the public’s confidence in the safety of all food.

Taking advantage of deliberately generated "food fear," will be used by advocacy groups to build momentum as they attract donations and target whatever next production practice they decide to dislike for whatever self-interested reason. Corporate interests will jump on the bandwagon in a greedy effort to capture some temporary advantage in the marketplace. More ill-conceived demands will be made of producers: rationality, science, practical impacts, environmental and consumer costs not withstanding.

The abundant, efficient and cost-effective production of wholesome food for society will be the victim.

Click here for complete article (and single page version).

“Hype and exaggeration”

Parents in England are refusing to allow their children to be weighed by school officials, perhaps understanding the harm that results to their children better than officials.

A new Independent article suggests that the Public Health minister may be using this excuse to explain unimpressive numbers to support a childhood obesity crisis when the National Childhood Obesity Database is released this Wednesday.

But health officials’ claims of a childhood obesity epidemic have come under criticism before for not being supported by the evidence and being primarily “hype and exaggeration.” Dr. Peter March, co-director of the Social Issues Research Centre said “there has been very little change [in child obesity rates] over the last decade, contrary to the lurid warnings that the current generation of children will die before their parents.” An analysis of the annual Health Survey for England issued last year by the Social Issues Research Centre concluded:

There have been no significant changes in the average weights of children over nearly a decade. This can be taken as evidence that there has been no ‘epidemic’ of weight gain.”

The assumption is that as our children and young people get fatter their health suffers correspondingly. The Health Survey data, however, do not support this view. There has been no change in the incidence of acute illnesses and, more importantly, no rise in the number of children suffering from longstanding illnesses, which includes type II diabetes. There has, in fact been a slight decline.

Among their other findings:

* BMI trends have been broadly flat for both boys and girls aged under 16 years in the period 1995 – 2003, with very modest increases in average BMI of around 0.5 for boys and 0.6 for girls.

* There is no indication of any significant change in the number of children with chronic illnesses, including type II diabetes, over the past 9 years. The absence of any evident deterioration in the health status of children supports the conclusion that children are not becoming fatter as fast as is widely believed.

* The prevalence of obesity is strongly related to age. The 16-24 year age group – both males and females – is substantially less at risk of becoming obese than older age groups, and the incidence of obesity for males in this age range has declined very slightly in recent years.

* More young men and women in the 16-24 age group have a 'desirable' BMI of between 20 and 25 than any other BMI category. Men of this age are twice as likely to be underweight as they are to be obese.

SIRC report concluded: “The Health Survey for England provides grounds for a serious re-think.”

Click here for complete article (and single page version).

The scientific evidence behind health care benefit and employer wellness programs

© Sandy Szwarc 2006

The National Business Group on Health (NBGH) has just released their “Purchaser’s Guide to Clinical Preventive Services: Moving Science into Coverage,” funded by a grant from the Robert Wood Johnson Foundation. It is “designed to help employers offer coverage for 46 clinical preventive services proven to be effective in preventing illness and premature death of their employers and families and potentially reduce their healthcare costs.”

“This is public health science research in action — a guide to provide employers with advice on how to have a healthier, more productive workforce,” said CDC Director Julie Gerberding, M.D.

The Guide promises its recommendations are based on scientific evidence of clinical effectiveness, but a close examination reveals they aren’t.

Although you may not be familiar with the NBGH, your employer certainly is. This group has been the forerunner of the “costs of obesity” claims and one of the most vocal proponents of employer-mandated “wellness programs,” health screenings and obesity interventions. NBGH is also the group promoting incentives to compel compliance with wellness and health guidelines for people receiving private or federal health insurance (for instance, premiums billed according to participation in wellness and weight loss programs); Health Savings Accounts; third-party payer “evidence-based benefit designs” to compel compliance with insurer guidelines among physicians and healthcare providers; and informational technology to develop national databases of health records.

Since 2003, this organization has had an entire Institute on the Costs and Health Effects of Obesity devoted to its agendas. NBGH Founding Board members, as well as their current Institute Board members, include the country’s largest employers, insurance companies, pharmaceutical companies, weight loss programs, bariatric surgery companies, for-profit hospitals, Health and Human Services officials and other interests.

Wading through their 494-page document with a critical eye doesn’t make for light reading but it does reveal some troubling inconsistencies, omissions and failures in their guidelines that employers use in determining covered health benefits and workplace health programs. While we could take many of their similarly-flawed clinical practice guidelines as examples, let’s examine the NBGH’s recommendations on obesity.

They recommend employers cover obesity screening for ages 2 and up; as well as counseling and weight loss treatments, including weight loss drugs and surgery as indicated, for ages 18 and older. They state successful treatment “can be expected to produce significant health benefits.”

Support for their recommendations relies primarily on the U.S. Preventive Services Task Force recommendations. The USPSTF is sponsored by the Agency for Healthcare Research and Quality, the Federal government’s lead agency under the U.S. Health and Services Department (a NBGH Board member) for research on health care quality, costs, outcomes and patient safety. It is charged with issuing careful, evidence-based findings that are used to develop clinical guidelines for healthcare providers and justify all aspects of government healthcare spending and HHS health policies. As their 2006 Congressional budget report says, they have made “significant improvements in realigning the work we do with our strategic goals and those of the Department.” So not surprisingly, the very first reference listed in the USPSTF’s “Screening and Interventions to Prevent Obesity in Adults” used in the NBGH Guide was the HHS’ 2001 “Surgeon General’s Call to Action to Prevent and Decrease Overweight and Obesity.” [See: The Emperor’s New Crisis.] The other selected references were similarly weighted, which makes their unenthusiastic conclusions about the evidence in support of obesity screening and interventions especially remarkable and commendable.

Even so, the NBGH Guide found them sufficient to support their recommendations, stating:

The U.S. Preventive Services Task Force recommends that clinicians screen all adult patients for obesity and offer intensive counseling and behavioral interventions to promote sustained weight loss for obese adults....There is fair to good evidence that high-intensity counseling — about diet, exercise, or both — together with behavioral interventions aimed at skill development, motivation, and support strategies produces modest, sustained weight loss (typically 3 to 5 kg for 1 year or more in adults who are obese.

Modest weight loss maintained for a year is hardly commanding evidence of long-term effectiveness for intense interventions. In fact, the dismal failure of any type of intervention in achieving long-term success was highlighted in the acclaimed, comprehensive review of more than 500 studies on dieting and weight loss by David Garner, Ph.D., and Susan Wooley, Ph.D.. They concluded: “It is difficult to find any scientific justification for the continued use of dietary treatments of obesity.”

Nevertheless, the Guide left out key sentences from the actual USPSTF report:

The evidence is insufficient to recommend the use of moderate- or low-intensity counseling together with behavioral interventions to promote sustained weight loss in obese adults...The relevant studies were of fair to good quality but showed mixed results....studies were limited by small sample sizes, high drop -out rates, potential for selection bias, and reporting the average weight change instead of the frequency of response to the intervention. As a result, the USPSTF could not determine the balance of benefits and potential harms of these types of interventions.
· The USPSTF concludes that the evidence is insufficient to recommend for or against the use of counseling of any intensity and behavioral interventions to promote sustained weight loss in overweight adults.

In fact, according to the USPSTF, evidence for dietary counseling was “limited by reliance on self-reported diet outcomes, limited use of measures corroborating reported changes, limited followup data beyond 6 to 12 months, and enrollment of study participants not representative of the primary care patients.”

Effectiveness

Despite no evidence for long-term success of any program, the NBGH Guide goes on to recommend interventions for obesity, combining diet and exercise counseling and behavioral strategies to help obese patients acquire the skills they need to change their habits.

The Guide admits that the USPSTF concluded that the evidence was insufficient to recommend routine screening for overweight in children and adolescents as a means to prevent adverse health outcomes. But they disregard the lack of evidence and include interventions for children, with the justification that screening is included in certain health organization guidelines.

Benefits

Concerning the benefits of weight loss among adults, the NBGH Guide states:

Although the USPSTF did not find direct evidence that behavioral interventions lower mortality or morbidity from obesity, the USPSTF concluded that changes in intermediate outcomes, such as improved glucose metabolism, lipid levels, and blood pressure, from modest weight loss provide indirect evidence of health benefits.

In other words, there is no evidence that weight loss interventions reduce “morbidity” — actual clinical illness or disease — or premature deaths, but since certain measurements and lab numbers change there must be some health benefits!

The Guide goes on to make their case for benefits of weight loss:

For adults, losing excess weight has positive effects on overall health status. A 5% to 7% reduction in body weight decreases the risk of type 2 diabetes, reduces blood pressures, and improves lipid profiles...The USPSTF found limited data on the positive effect that weight loss may have on overall mortality, mental health, and daily functioning.

Notice they felt necessary to reiterate how limited any supporting data was for any actual benefits of weight loss. But what is important to note is that they confuse “risk factors” with actual disease and indications of health status. They define “risks” by using indirect measures — blood sugar levels, blood pressure or cholesterol levels — they believe to be associated with real disease and hope readers (employers) will think those mean the same as the actual disease and measures of health. But the evidence has repeatedly shown that they are not.

In 1992, the National Institutes of Health held what is still the most pivotal conference on Methods for Voluntary Weight Loss and Control, in which the country’s top experts reviewed nearly half a century of evidence on voluntary weight loss. It concluded that most studies, and the strongest evidence, show voluntary weight loss regardless of the method, although seemingly to reduce risk factors, is actually strongly associated with increased rates of premature deaths, heart disease, stroke, type 2 diabetes and cancers — by as much as several hundred percent.

What is rarely mentioned is that in short-term studies claiming dieting improves health, they all use intermediate measures — those indirect measures have been shown to initially improve with any caloric deficit but quickly take a dramatic turn around and rebound, often surpassing pre-weight loss levels. And more importantly, the weight loss actually shortens lives.

Dr. Reubin Andres of the National Institute on Aging admitted that weight loss can improve blood sugar levels, blood pressure and cholesterol in the short term. “The only problem is that when you look at mortality rates,” he said, “they don’t look good. Fat people who are subject to weight loss have a higher mortality rate than those who remain fat.”

Safety and Risks

But the Guide is especially troubling in its failure to discuss the risks surrounding their proposed interventions. While giving a cursory nod to the USPSTF’s mention of potential harm of weight cycling and the stigma of labeling people as “obese,” and of pharmacological and surgical interventions, the Guide states:

The USPSTF was unable to find studies that suggested harms associated with screening or counseling obese patients....The USPSTF concluded that the benefits of screening and behavioral interventions outweigh potential harms.

They didn’t try very hard to find the studies, and it is unlikely that many employer benefit managers will take the time to do so, either. If so, they would discover volumes of evidence showing harms from weight loss interventions, just as the NIH had reviewed. And the dangers identified at the NIH conference were not the result of enormous weight losses or extreme diets, but as little as 10 pounds and even moderate calorie restrictions. As the experts at the NIH reported, studies that appear to show benefits of weight loss are seriously flawed. Study after study — Framingham Heart Study, CARDIA study, the CDC NHANES I, MRFIT, Harvard Alumni Study, Dutch Elderly, Alameda County, Baltimore Aging, Honolulu Heart, Lipid Research, British Heart — has shown that weight gain with age, or stable weights, for both men and women offers the lowest death rates; while dieting, weight loss or fluctuating weights (yo-yoing), significantly increases the risk of actual death, cardiovascular diseases, type 2 diabetes and cancers.

Since then NIH review, research has continued to indicate potential harm from weight loss endeavors, among adults of all sizes. And the evidence of harm for growing children is considerably greater. In studies this writer has outlined previously, women losing just 1-19 pounds had 70% higher rates for premature deaths, 62% increase in death from cancer, 167% increase in death for heart disease and stroke. Studies of men with intentional weight loss of a mere 10 pounds increased their mortality from heart disease by 60-242%.

Other potential dangers from dieting that have been documented in clinical studies include:

· reduced bone mass

· cardiac arrhythmias

· eating disorders

· diminished brain function, loss of concentration, mental acuity and work productivity

· nutritional shortages, notably calcium and iron

· long-term exacerbation of high blood pressure

· and long-term weight gain!

It is doubtful that many employers read the medical literature, however, to get the complete picture on these NBGH recommendations, including the lack of proven long-term effectiveness, the poor evidence for actual health benefits, and the overwhelming evidence for potential risks to their employees. Nor are they probably aware that the mandated employee screening, weight loss and “wellness” programs they are initiating as a result of the NBGH guidelines may prove to be a liability for their companies.

But consumers have an interest in the research. And employees might rightly ask if an employer or government can force them to comply with policies that have no sound evidence of being effective or beneficial, but do have evidence they could jeopardize their health.

Click here for complete article (and single page version).

FDA puts Acomplia on slow track

New drug development and approval process

As reviewed here at Junkfood Science, the full story on Acomplia, the new “miracle weight loss pill” being promoted by Sanofi-Aventis, is considerably different from that presented in the media. Perhaps the FDA reads this blog. :)

In a surprising move, the FDA has just put Acomplia on a slow track and deferred decision on whether to approve it until concerns over its side effects are reviewed by an FDA advisory panel on June 13, 2007.

This is newsworthy because it runs contrary to the FDA’s new accelerated drug approval process for obesity and diabetes drugs initiated in 2003 under FDA commissioner Mark McClellan and Deputy Commissioner Lester Crawford. It was just one of the government’s comprehensive obesity initiatives. Under the FDA’s Obesity Working Group, created by McClellan and chaired by Crawford, a range of government programs were developed to educate the public of the dangers of obesity and role of diet and exercise, prioritize research and weight loss interventions, and encourage healthy foods.

The accelerated approval track under FDA guidelines has traditionally been used to speed to market drugs that treat life-threatening diseases on behalf of patients with low-survival expectations and no other treatment options. Over the past ten years, it has been used for drugs that treat things like AIDS and late-stage cancers. The FDA’s fast track can cut a year or more from the clinical trial phase of drug development and run these drugs through the FDA review period in as little as four months.

In a speech to PhRMA on March 28, 2003 McClellan told the pharmaceutical industry of these new regulatory and inspection efforts for obesity and diabetes drugs to “reduce the time and cost of product development.” As the Boston Globe reported, under this new approval process, it would also “allow drug companies to win licenses for new therapies based on preliminary indicators — measures such as weight loss or lower blood sugar — instead of waiting for completion of lengthy phase III clinical trials that show long-term effectiveness” in actual clinical outcomes.

Most consumers probably missed the story just two months ago when Lester Crawford, former FDA commissioner, pled guilty to a conflict of interest charge and for making false financial disclosures to the U.S. Senate and the Executive Branch. He’d failed to disclose significant financial interests in companies which stood to benefit from the recommendations of the FDA’s Obesity Working Group he oversaw. Crawford is scheduled to be sentenced on Jan. 22, 2007 and faces a sentence of up to one year in prison on each charge. According to the U.S. Department of Justice press release, however, “there is no evidence that the OWG’s conclusions were altered because of the Crawfords’ ownership of the stock.”

Click here for complete article (and single page version).

Hormones and breast cancer

Dr. Emily DeVoto at the Antidote wrote a careful analysis — "Startling" if true — of the news reports attributing the 15% drop in breast cancer rates to reduced use of hormones among women.

...The report is fascinating. It really is a bunch of experts - evidence-based experts at that - sitting around saying, in effect, "Huh. Yup. I guess that's what it must mean," but tentatively, because, as one of them points out, epidemiology (or non-randomized observational studies) cannot prove causation. Particularly this type of study, of ecologic design, which compares population-wide rates of hormone use with cancer incidence. The drop in hormone use is what some people - environmental scientists, for example - call a "natural experiment." The Women's Health Initiative was the only randomized study (read: experiment) to look at health effects of hormone therapy (Prempro, specifically), and breast cancer was one whose incidence was slightly elevated, along with heart attacks, stroke, and blood clots. The Wyeth spokesperson interviewed for this article was skeptical of the explanation, and said that more studies need to be done; sure (see below), but there is not going to be another study on the scale of the WHI to replicate a causal relationship. Sorry.

A good point made in an AP article is that stopping hormones may in part have slowed the growth of existing tumors, which could still come to light at a later date. Another factor to look at is screening, but you'd really have to see dramatic changes in screening utilization to explain these results. Clearly, there's a lot more interesting work, and closer looks at the numbers, to be done on this finding...

Click here for complete article (and single page version).

Weekend Special Feature: The hidden faces of eating disorders

Two recent studies in the news offer an invaluable opportunity for all of us to better understand disordered eating. The common belief, a carry over from Victorian times, is that eating disorders are mostly a nervous affliction of young women. Popular media depicts anorexia nervosa by focusing on the most extreme cases and giving us shocking images of women who’ve starved themselves close to death. These sensationalized examples may make good copy, but they’ve led most people to believe that those suffering from eating disorders are anomalies, rare and freakish. This misconception not only detrimentally labels its victims, it also means we fail to recognize, and reach out to help, the many who are suffering who don’t fit that mold.

The media paid little attention to these new studies, not recognizing their significance. But both studies highlighted a serious concern within the medical profession about how to identify and define the myriad types and severities of eating disorders which don’t fit the classic clinical definitions.

Little kids

The first study, published in the Journal of Adolescent Health, was by researchers at the Stanford University School of Medicine and Lucile Packard Children’s Hospital. They examined the records of 959 patients, ages 8 to 19, who had been seen by a child psychiatric expert and medically assessed by medical specialists at their academic medical center between 1997 to 2005 and been diagnosed with eating disorders. They found that many children don’t fit the criteria for a diagnosis of anorexia nervosa, according to the official adult guidelines from the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV). These researchers reported that children sufferers don’t always have body dissatisfaction or present under 85% of their “ideal” body weight and, if they’ve not yet reached pubery, don’t really meet the criteria for amenorrhea (loss of menstrual periods).

Most astute practitioners give children and teens the diagnosis of EDNOS (“eating disorder not otherwise specified”), while others may fail to recognize a problem at all, especially among younger patients who are less likely to binge, purge or use laxatives or diuretics. Yet, in school-based studies of the general population, preoccupation with weight and eating is surprisingly common in children, with 20 to 56% dieting, up to 71% exercising trying to lose weight and up to 10% having experimented with vomiting. School children assessed using the Children’s Eating Attitudes Test, found 10.5% of 10-14 year olds and 6.9% of 7-13 year olds met the clinical threshold for disordered eating.

This study was the first to describe a large group of very young children with eating disorders. They found that, unlike teens, younger patients were more likely to be boys, to weigh considerably under their ideal weight by the time they were identified, and lose weight much faster than teens. These younger children had not only stopped growing but had even lost weight. While it’s especially imperative for parents and healthcare providers to recognize the problem quickly in younger children, it can be difficult, said lead researcher, Rebecka Peebles, M.D. Very young children don’t always express the same types of body image disturbances and call themselves “fat” or know why they don’t want to eat. “They just don’t want to be bigger.”

“Pediatricians and parents shouldn’t think of weight loss, or even lack of weight gain in a pre-teen, as a phase,” cautioned Dr. Peebles. “If a child expresses wanting to lose weight, take it seriously.”

Bulimics

The second study was published in the International Journal of Eating Disorders. Australian researchers at James Cook University in Townsville studied women with bulimia-type eating disorders. While the popular perception of bulimia nervosa is of people vomiting, the disorder also applies to those using other forms of purging such as abusing laxatives and diuretics. There are also non-purging forms of bulimia characterized by excessive exercising or dieting to counter binge eating episodes. And there are still others, according to the researchers, who fall short of meeting all of the criteria and only fit in the EDNOS category.

Nearly half of the women diagnosed with bulimia nervosa in this study didn’t see that they had an eating disorder. And those who didn’t use vomiting were six times less likely to realize they had a problem. Doctors were equally unlikely to recognize the seriousness of these eating disorders, even in the women seeking treatment. They were apt to treat them for depression or anxiety and leave the eating disorder unaddressed, said study co-author Dr. Jonathan Mond.

There’s a general perception, he said, that excessive exercising and strict calorie counting are acceptable and even “desirable.” They are not.

Those who don’t fit the stereotype

When popular images and beliefs about eating disorders focus on severely gaunt young women primarily motivated by desires to be thin, many sufferers don’t see themselves in such depictions. Hence, they may not realize they have a problem, nor are their problems recognized by friends, family and healthcare providers. Yet they have all of the same mental processes and physical behaviors, and suffer the same reduced quality of life and many of the same nutritional and health problems to varying degress, of clinically diagnosed anorexia nervosa and bulimia nervosa.

Many with disorderd eating don’t look the part — they may have “normal” body weights or even be fat. It is possible to weigh 15% below the body weight genetically natural for them and still not appear “underweight.” Because our society wrongly believes everyone eating “right” will fall within a “normal” weight range, many of these sufferers “pass” for normal. Or, they’re admired and seen as just very “thin and healthy” women and men. But they are exhibiting the same controlled eating and dietary restrictions, over-exercising and the other behaviors of their clinically-diagnosed anorexia nervosa and bulimia nervosa counterparts.

Many of these sufferers won’t ever reach the extreme state to fall under the traditional clinical diagnosis of eating disorders, even though they’re below a weight natural for their bodies, their lives are tormented by body weight concerns and their energies are devoted to staying slim. Their suffering and need for help usually go unrecognized and untreated. Sadly, they are invisible, marginalized and their problems are never taken seriously.

Thinness in our culture is seen as representing success, wealth, power, self-control and health. There are very few fat women depicted favorably in popular culture. Our society has come to see dieting and concerns over our figure as normal feminine behavior and it’s even supported and encouraged among girls, especially as they approach puberty and teen years — a time when it’s normal and healthy to gain up to 20-30% of body weight in fat as their bodies ready for menstruation and the ability to bear children. When boys start eating parents out of house and home, it’s considered a normal part of growing up. But when girls bodies hit growth spurts and they’re naturally driven to eat more, they are frowned upon. Growing girls are told their natural, normal appetites are “overeating” and they’re made to believe they have problem “issues” with food and must watch what they eat to avoid gaining weight.

Females are raised on media images of women 23% or more below what the average woman weighs, with unnaturally bony bodies lacking any fat or womanly curves. So when their own bodies begin to fill out normally, panic sets in. Research has repeatedly shown that parents become similarly concerned by the normal blossoming of their daughters.

With the “ideal” woman’s body so severely below what is normal, most women have come to hold unrealistic ideas of what women should weigh and look like. Weights of 140-150s are healthy for women of average heights, but 100 pounds has become the magic number many women live by. If they don’t weigh under 100 pounds they often don’t believe they have a problem.

Girls striving to attain unrealistic ideals are much more likely to be drawn into dieting behaviors. While dieting itself is believed by many clinicians to be a subclinical eating disorder, it is recognized as one of the primary physiological and psychological triggers for full-blown eating disorders. The causes of eating disorders are complex, with multiple psychological, sociological and physiological components, but dieting and the accompanying (normal responses to) hunger is often overlooked as a factor.

Many of the rituals characteristic of eating disorders are also indistinguishable from the “healthy” eating tips encouraged in our culture: counting and restricting caloric intakes, measuring or controlling portions, not eating certain kinds of foods, exercising religiously and watching their weight. Don’t be fooled. This is not normal eating or required for “health,” it is dieting.

Not surprisingly, many people see young girls with disordered eating as just being “health conscious” and “typical girls.” It may be inherent upon the fathers to intervene and not simply regard dieting as a “girl thing.”

Similarly, when disordered, restrained eating and/or over-exercise (a mere 30 minutes of moderate physical activity most days of the week has been shown to impart metabolic health) is present among older women and men, it is often viewed as “healthy” lifestyles. In a July 2006 Thomson Medstate Research Brief, nearly 80% of 12,000 American adults surveyed who were underweight considered their eating habits very healthy or somewhat healthy.

Increasingly recognized is disordered eating among people driven by what they believe is a pursuit of health. They may not be tormented by fears of becoming fat as much as fears over the perils in foods and ill-health. They want to eat only foods that are “good,” nutritious and pure, and continually restrict what they eat to eliminate foods they believe are unhealthy, such as meats, refined sugars, artificial ingredients or packaged foods. Surrounded by the food fears in the media and the messages of the health benefits of certain foods, much like anorectics, they seek an illusion of safety and control, said Dr. Steven Bratman, M.D., medical director of Prima Health and author of Orthorexia Nervosa: Overcoming the obsession with healthful eating (2000). After seeing increasingly more people in his practice with this, Dr. Bratman was the first to recognize it as an eating disorder and label it “orthorexia nervosa.”

“The quest for healthy food can become a disease in its own right, said Dr. Bratman. “Obsession with a healthy diet is an illness, an eating disorder.” Its sufferers develop an almost religious devotion to healthy eating, he said. When what you eat is based on its healthfulness, that isn’t healthy, he said. Many of the orthorexics he’s identified adopt unsound dietary beliefs and extreme dietary practices, such as believing they have food allergies, need to eat organic or microbiotic, and require supplements to remain healthy and youthful. While it does not yet have a specific category in the clinical definitions of eating disorders, orthorexia nervosa is increasingly being recognized among clinicians as being a similar problem and even developing into clinical anorexia nervosa.

“To be really healthy, we have to relax, live a little, flow with the movements of life, and not grasp frantically after a perfect diet,” said Dr. Bratman.

Perpetual dieting; the pursuit of “healthy” eating, “healthy” weights and “fit” bodies; and all the accompanying fears over food and fat; have become so mainstream, that eating disorders have not only soared over recent years, they are much more common than we dare admit.

©Sandy Szwarc 2006

Click here for complete article (and single page version).

Promoting Healthy Body Image

* Discourage all dieting. Dieting is a risk factor for disturbed eating, eating disorders, weight cycling and ironically, future weight gain.

* Encourage members of the school community to listen to their bodies; eat when hungry and stop when full.

* Avoid labelling food as ‘good’ and ‘bad’. Food is not a moral issue.

* Role model eating and enjoying all foods, including nutritious, delicious and celebratory foods.

* Consider your own values towards weight, dieting and body image and how these impact on the school culture.

* Scrutinize books, posters and resources that endorse the cultural ideal of thinness and include stereotypical images.

* Avoid participating in body disparaging and dieting conversations.

* Role model valuing diversity.

* Emphasise and value self-esteem, critical thinking, assertiveness and respectful communication.

* Create a size accepting environment.

* Develop school policy on weight harassment. Bullying about size is associated with disturbed eating patterns.

* Link physical activity with enjoyment.

* Do not weigh students for any reason.

* Make sure that school policies and practices are congruent across the board with the promotion of healthy body images (e.g., coaches do not encourage weight targets while other staff simultaneously promote body satisfaction).

Adapted from Eating Difficulties Education Network by Jane Tyrer and Maree Burns

Click here for complete article (and single page version).

Friday Fun — Try this at home!

Do you trust your own experiences, and those of others, to provide better proof than empirical evidence?

How about putting it to a test?

These fun challenges show just how much our perceptions and things we believe are real very often aren’t!

Cave of Knowledge

Cave of Magic

Click here for complete article (and single page version).

Measuring quality or something else?

The latest issue of Journal of the American Medical Association examines performance measures being enforced by insurers and regulators, reportedly to improve clinical outcomes.

Medpundit looks at the study in JAMA led by Drs. Rachel Werner and Eric Bradlow. This study found that those “quality measures” mandated by third party payers don’t necessarily translate into quality care or better patient outcomes. In fact, the measures predicted small, insignificant improvements in mortality rates. Medpundit insightfully concludes:

Here's what counts for quality in hospitals - cleanliness and good nursing care. Hospitals don't measure those parameters, though. It's much harder to measure the worth of a nurse than to send someone around to check off documentation points on a chart. You can enact every principle of evidence based guidelines and it won't do squat for the patient if they are only attended by a nurse's aid with six weeks of training who can't recognize a turn for the worst, while the fully trained nurses are pre-occupied with fulfilling the documentation requirements.

We have vastly over-rated the improvements we get from easy pharmacological fixes while simultaneously under-rating the value of basic medical care and judgment. And with the coming of pay for performance, the mismeasure will only get worse.

And Dr. James Gaulte at Mdredux continues.

He discusses Dr. Susan Horn’s editorial appearing in the same JAMA issue which asked: “If these performance measures are not strongly associated with outcomes, why should we bother with them either as basis for P4P [pay-for-performance] or for consumers to use as tools for judging hospitals?” Dr. Horn noted that improving outcomes in actual real world practice is much more complex and multidimensional than using a few, discrete interventions that seemed efficacious and safe in randomized clinical trials. In part, it is the question of efficacy versus effectiveness. Measuring quality of care is much more complex and slippery than the ten measures measured.

In an earlier article, Dr. Werner pointed out some possible unintended consequences of hospital “report cards” including treating the chart and excluding sicker patients. Mdredux concludes:

One message should be: we have no business using simple and simplistic measures as a basis for pay for performance or for claiming to be able to distinguish between different hospitals quality of care. Not only may they not deliver on what they promise, they may be harmful.

A related Mdredux post on December 8 quotes the president of the American Medical Association, voicing his concerns of P4P measures being increasingly imposed on doctors, saying:

I will point out that-reminiscent of the managed care debacle-P4P will allow insurers to dictate the treatment that we give our patients and will publicly label any physician foolish enough to contract with them and not follow their dictates as nonpreferred, substandard or some such label.

This is not just speculation, wrote Mdredux, as physicians in Washington state had exactly that happen to them.

Medical professionals (this one included) are increasingly concerned that, like many of today’s clinical practice guidelines, these performance measures are heavily influenced by vested interests and not necessarily based on careful, proven science. Yet compliance with these clinical measures is also being imposed upon patients. Everyone is affected.

The news over recent years has been filled with discoveries of conflicts of interest among those establishing obesity and weight loss, diabetes and cholesterol guidelines. Health Care Renewal has posted frequently about allegations of conflicts of interest affecting top scientists and managers at the National Institutes of Health. Their most recent post noted that the US Food and Drug Administration (FDA) panel assessing drug-eluting stents for coronary artery disease includes six members with conflicts of interest.

Coming Monday: A review of the “Guide to Clinical Preventive Services” recently released for employers. Companies use it to help determine what health services to cover, as well as support “wellness” programs and health measures being imposed on increasing numbers of employees and recipients of government health benefits.

Click here for complete article (and single page version).

Junkfood Science Exclusive: “What if you could pop a pill and lose weight?”

©Sandy Szwarc 2006

CBS Evening News publicized just such a “magic pill” that’s already available in Europe and coming here. Viewers were told that this “remarkable new obesity drug shows promise as an entirely new class of drugs” and works by turning off the same part of the brain that’s turn on by marijuana and gives people those classic munchies. The drug is rimonabant, also known as Acomplia. The dieter interviewed in the story called it “my miracle pill.”

The CBS Early Morning Show followed up with an interview of one of the diet doctors who had participated in the pharmaceutical company’s trials, Dr. Lou Aronne, director of the Comprehensive Weight Control Center in New York City. He explained that emerging research was showing that Acomplia blocks cravings for nicotine and alcohol, and cravings for food that are “out of control in people who are overweight and obese.” The only downside, viewers were told, were mild, uncommon and transient side effects of nausea, dizziness, anxiety and depressed moods. FDA approval has been held up, but Dr. Aronne said he didn’t know what the FDA’s concerns might be.

Within hours, media across the country headlined Miracle Pill May Help Trim Fat, which Google documented in pages of links like this:

'Miracle Pill' May Help Trim Fat

KUTV, UT - 3 hours ago

... "I'm not going to be fat and 60. I want to be slim and 60.". The pill is called Rimonabant and is sold in Europe under the brand name Acomplia. ...

'Miracle Pill' May Help Trim Fat

WJZ, MD - 8 hours ago

... "I'm not going to be fat and 60. I want to be slim and 60.". The pill is called Rimonabant and is sold in Europe under the brand name Acomplia. ...

'Miracle Pill' May Help Trim Fat

CBS 5, CA - 8 hours ago

... "I'm not going to be fat and 60. I want to be slim and 60.". The pill is called Rimonabant and is sold in Europe under the brand name Acomplia. ...

'Miracle Pill' May Help Trim Fat

CBS4Boston, Boston - 8 hours ago

... "I'm not going to be fat and 60. I want to be slim and 60.". The pill is called Rimonabant and is sold in Europe under the brand name Acomplia. ...

'Miracle Pill' May Help Trim Fat

CBS 11, TX - 8 hours ago

... "I'm not going to be fat and 60. I want to be slim and 60.". The pill is called Rimonabant and is sold in Europe under the brand name Acomplia. ...

'Miracle Pill' May Help Trim Fat

cbs4denver.com, CO - 8 hours ago

... "I'm not going to be fat and 60. I want to be slim and 60.". The pill is called Rimonabant and is sold in Europe under the brand name Acomplia. ...

'Miracle Pill' May Help Trim Fat

KDKA, PA - 8 hours ago

... "I'm not going to be fat and 60. I want to be slim and 60.". The pill is called Rimonabant and is sold in Europe under the brand name Acomplia. ...

'Miracle Pill' May Help Trim Fat

WCCO, MN - 8 hours ago

... "I'm not going to be fat and 60. I want to be slim and 60.". The pill is called Rimonabant and is sold in Europe under the brand name Acomplia. ...

'Miracle Pill' May Help Trim Fat

CBS 5 - Green Bay, WI - 8 hours ago

... "I'm not going to be fat and 60. I want to be slim and 60.". The pill is called Rimonabant and is sold in Europe under the brand name Acomplia....

If it all sounds a bit too wonderful, sort of like those gushing weight loss infomercials, you’re right to suspect that there is more to this story we are not hearing. In fact, that was exemplified when no publication in the country queried with this article would dare publish this information. What is of serious concern for this medical professional is just how little is known about this pill; the only clinical evidence is short-term and much less impressive than the public is being led to believe; its new mechanism of action works on the central nervous system, with potentially far-reaching ramifications; and what evidence is available gives every indication of a time bomb far worse than any of the weight loss drugs to date...

Several things were notably absent from the news story, according to Acomplia Report of Medical Week, an independent medical newsletter that’s been following Acomplia’s development for years. Viewers weren’t given information on how much weight she’d lost, the side effects or long-term complications of this new drug. Interestingly, the only dieter interviewed on the news also happened to be the patient acting as a spokesperson, appearing in the drug company’s news conference.

Incentives

Since the world’s third largest pharmaceutical company, Sanofi-Synthelabo (now Sanofi-Aventis), began animal testing of rimonabant in 1996, an intense campaign has unfolded, creating a huge buildup that was supposed to have culminated in FDA approval this fall. Sanofi has drawn criticism from the medical community for releasing drug information to the media and financial investment communities, and at industry conferences, rather than in peer-reviewed medical journals where the data can be carefully reviewed. Through company-sponsored doctor educational programs and conferences, Sanofi has also been laying the groundwork to create acceptance of a new disease, the “metabolic syndrome:” a range of laboratory findings that Acomplia is said to treat.

The market potential is huge, with some forecasts predicting peak sales of $5 billion. While the drug has been introduced in six European countries, with 3-month sales early this fall of $14 million, the really big money is in the U.S., which Business Week reports is expected to account for two-thirds of the potential profit base. They also report that troubles have been mounting for Sanofi and the company is “under intense pressure to get Acomplia into the U.S. market — fast:”

One of its newer drugs—antibiotic Ketek—is under intense scrutiny from the U.S. Food & Drug Administration after it was linked to a dozen cases of acute liver failure, including four deaths. The drug also is at the center of a U.S. congressional investigation into allegations that it was approved despite the FDA's own findings that a key study contained fraudulent information.

The clinical trial evidence — weight loss unremarkable

The latest results of the company’s clinical trial for FDA approval — RIO-North America — were recently published and the results were decidedly less “wonderful” than we heard in the news.

This was a randomized, double-blind, placebo-controlled Phase III drug trial of 3,045 healthy adults. There were two treatment groups, one receiving a lower dose (5mg) and one receiving the full, higher dose (20mg). They were all also put on a low-calorie diet, cutting about 600 calories a day. After one year, those on the highest dose had lost 14 pounds, versus 4 pounds in the placebo group — a 10 pound difference. [If you believe the theories of calories in - calories out and that you lose one pound for every 3500 calories less you eat, the treatment group even without the pill “should” have lost 63 pounds after a year! Just goes to show....]

At the end of the first year, half of the treatment group was put on a placebo to see if they would maintain their weight loss — they didn’t. At the end of the second year, they had regained their weight and were nearly identical to the people who’d been taking the placebo the entire time. At the end of the second year, 40% of those who had continued to take the high-dose had maintained “a weight loss of 5% or greater” compared to 19% of the placebo group.

The weight loss demonstrated in the RIO-Europe Study was similar to the North American limb of the clinical trials: 19 pounds for the 20 mg treatment group and 8 pounds for the placebo group — a difference of 11 pounds.

So, by taking this pill for two years, along with dieting, you could lose an additional 10-11 pounds more than if you hadn’t taken the pill. This small weight loss is never going to make any “obese” person slim. And clearly, that’s not the “miracle weight loss” many believe is being offered.

Complications

The FDA, however, has postponed its approval until next year, requesting more information. Sanofi is not disclosing the FDA’s concerns but they aren’t difficult to surmise. Given how this drug is supposed to work, the side effects being reported may not be as benign as they seem and there are worrisome indications of serious potential problems.

A point to remember with pre-approval drug trials is that the participants differ from the general population. Researchers carefully screen people to include only those without any health problems, in order to minimize adverse reactions and help put the best light on the drug in development. So any complications that are reported deserve close attention. The only clinical evidence on actual people we have are the company’s drug trials where the pills were given to a few thousand people. We don’t know what will happen when it’s given to a million people, all with a variety of conditions and many taking other medications. Many complications won’t appear during short-term trials. Certainly weight loss drugs have had a less than exemplary track record, as their most serious risks came to public light after their release. And too late for many.

The RIO-North America researchers reported that side effects were mild and that the most significant one was nausea in about 11% of the treatment group, versus 6% in the placebo group. But one might rightly suspect that the side effects were considerably more significant than they have indicated because, despite the fact these participants were highly motivated to be part of a miracle new weight loss drug trial, more than half had dropped out after just one year and another 23% of the remaining treatment group during the second year! So the clinical trials have only told us the effects on far fewer than half of the people in the study.

According to the doctors at Medical Week, the most comprehensive review of Acomplia’s side effects available to date were presented as part of the European approval process by the European Medicines Agency. They reported only 15.7% of patients had adverse reactions, but upper respiratory tract infections and nausea were “very common” (more than 1 in 10). And “common” (between 1 and 10 per 100) were: gastroenteritis, depression, anxiety, sleep disorders, memory loss, dizziness, sciatica, diarrhea, vomiting, skin problems, muscle cramps and spasms, fatigue, falls and joint sprains and tendonitis.

It is also noteworthy that despite the trial participants being carefully screened for any hint of psychiatric problems, there were nearly three times more cases of psychiatric disorders developing among the 20mg treatment group, as compared to the placebo. And doctors at the VU University Medical Cantre in Amsterdam reported in 2004 that within months of starting the pill, a healthy 46-year old woman developed multiple sclerosis. That certainly does not prove that the pill was the cause, but we’ll look in a minute at why this finding is especially troubling.

In contrast to what was seen on television here in America, a report last month of British users gave a different perspective of patient experiences:

“I went to my GP (general practitioner) because my usually lovely wavey hair had become thin and lifeless. I had black bags under my eyes and began getting really bad hot flushes five or six times a day. I think I aged 10 years in 8 weeks....My GP took one look at me and told me to stop taking it immediately.”

“The worst thing has been the anxiety, waking up feeling as though something really terrible has happened and not being able to shake the feeling all day. Being really tired and wanting to just lie down and sleep... I have been off them for 2 weeks and I still feel ill.”

“I experienced the hair loss, the upset tum, the dizzyness (I was misjudging spaces and walking into door frames) persistent crying (or feeling like crying) and the cravings. To be honest I flushed them down the loo...I feel much better but it took several weeks to get back to normal.”

A glance to the future?

Whenever we take a drug for the side effects we want, we have to weigh all of the other side effects that come along for the ride that we may not want. Media and researchers give the public a very simple explanation for how this drug supposedly works, equating it with just blocking those marijuana munchies. But it is not that simple.

The drug blocks “cannabinoid-1 receptors,” which allow us to experience the pleasures of eating, but also to feel other sensations of pleasure and joy. These receptors are also found throughout our central and peripheral nervous system and reproductive system. They are involved in maintaining not just our eating, but also reproduction, relaxation, sleep, our emotions and cognitions, and learning. They regulate all of our body systems, said Robert Melamede, PhD, of the University of Colorado, Colorado Springs, in a comprehensive review of the scientific evidence on cannabinoids. Laboratory and animal studies indicate they appear to play a role in:

·reducing pain

·stress-induced analgesia

·reducing inflammation, auto-immune diseases and other immune responses where tissue damage is involved, such as multiple sclerosis, arthritis, Crohn’s disease and diabetes

·defending against a number of neurological degenerative diseases and helping to protect the brain after head injury or stroke

·reducing spasticity

·regulating body temperature

·inhibiting the growth of types of cancer cells, such as in leukemia, lymphoma, skin, breast, prostate, lung, thyroid and colorectal cancers

·reducing nausea and vomiting

·forgetting painful memories and fears

·promoting mental stability

·regulating cardiac rhythms and protecting the heart from oxygen deprivation

·inhibiting the action of a family of enzymes needed to metabolize a variety of prescription drugs

·fertility

“The capacity of cannabinoids to down-regulate a spectrum of auto-immune diseases should serve as a warning against the long term use of CB1 inhibitors for weight control,” said professor Melamede. With this knowledge, the potential significance of that 2004 report of a healthy woman suddenly developing multiple sclerosis is more explicit. “Many of the biochemical imbalances that cannabinoids protect against are associated with aging,” he reported. While there is no clinical trial evidence examining long-term complications of taking this pill, the available experimental and animal studies offer some very worrisome and far-reaching possibilities.

Commentary: It is tragic that we’ve grown so afraid to let ourselves enjoy eating and afraid to accept our natural and varied body sizes, that we would consider taking a pill that could not only jeopardize our health, but eliminate from our lives all pleasure and feelings of exhilaration and happiness. With two-thirds of the population being targeted for this pill, will the risks and benefits and the possible consequences be carefully considered - or even made known - before people rush to try it? What might happen when so many people find themselves living joyless lives and possibly unable to feel happiness, finding no meaning or significance to life, not feeling, and simply not caring about anything anymore? What will become of our creativity and joys of creating beauty in the world? What might be the costs for society in rates of depression, stress disorders, divorce, school drop-out, reduced work productivity and suicide?

And all to lose a few pounds. Nothing better demonstrates the insanity of all of this.

Click here for complete article (and single page version).

The growing popularity of subzeros

The perception of what is a natural body for a woman has become far removed from reality. Most American women have weighed around 145-155 pounds for generations, but that is now considered fat. Marilyn Monroe, at size 12-14, once epitomized the “ideal” figure. Now, the “ideal” figure is size zero or less. Today’s young women are striving to reach increasingly tinier dress sizes, as this fashion article notes:

How low can you go?

Could subzero become the next status symbol for size-conscious women?

The ideal women's size has been shrinking for years, and now more designers and retailers are introducing a less-than-zero size, sometimes called "subzero" or 00. Designer Nicole Miller plans to introduce the size in next fall's line, and last spring Banana Republic started selling size 00 online.

But some experts worry that the proliferation of such a tiny size could cause eating disorders as some women aspire to shrink to subzero.

"They love the size zero," Tony Paulson, clinical director for Summit Eating Disorders and Outreach Programs in Sacramento, Calif., says about some women he treats. "For some reason, that's almost a badge of honor to them, to reach a size zero. Now they have another goal, to reach this sub-size zero."

If this decade's ideal body type is superskinny, a glance down the fashion timeline is a reminder that it wasn't always this way.

In the 1950s, a size 12 Marilyn Monroe wrote the body-type rules....And in the 1990s, Pamela Anderson summed up the ideal: impossibly slender with impossibly large breasts.

"What happens is that the beauty ideal keeps on changing, and you have a lot of adolescent girls who are striving for that," Mr. Paulson said. "Unfortunately, for most of the girls, it's completely unrealistic."

Most women just aren't built that way. The average American woman is 5-foot-4, weighs about 155 pounds and wears size 14.

The average model? She stands at 5-foot-9, weighs 110 pounds and wears a 0 or a 2, according to the Social Issues Research Centre in Oxford, England.

Click here for complete article (and single page version).

Dirty chicken or foul fears?

It seems we can’t turn on the news without hearing some scary story about the deadliness of our food. Regrettably, most of us don’t realize that the level of media-reported crisis is more reflective of politics than the safety of our food supply. Special interest consumer groups, led by the Center for Science in the Public Interest (CSPI), are working for legislation to create a new agency for food-safety, with increased authority to enforce new regulations and penalties. It’s part of their global initiatives begun two years ago to organize consumer groups around the world to regulate multi-national food companies.

But when it comes to the safety of the foods we select for ourselves and our families, most of us don’t want politics, we just want the facts.

According to the latest headlines “Raw chicken is dirtier than ever.” Consumer Reports, a publication of the Consumers Union, just published a report asserting that poultry “are a lot dirtier than in the past, harboring large amounts of campylobacter or salmonella bacteria that can make people sick.” In a test of 525 chickens purchased around the country, they said 83% were contaminated, up from 49% in 2003. They added that organic chickens, produced without antibiotics, were more likely to harbor salmonella than conventionally-raised chicken that cost up to five times less.

“We think it’s really startling,” said Jane Halloran, a policy director for Consumers Union (one of the organizations partnering with CSPI in its global food safety initiatives). “It’s a very significant deterioration in food safety.”

But is it? And should we be afraid?

Every time we hear something that sounds scary, it’s our clue that what we’re hearing is likely to be marketing, appealing to our emotions, rather than good science or a balanced perspective.

Nature is not sterile. Even the most pristine picturesque farms, crystal clear streams and wholesome foods are not sterile. There are germs everywhere and on everything we touch. But the mere presence of germs doesn’t mean we’re going to get sick, and especially not if we take prudent care to wash our hands and handle foods safely [See FightBac!]

Remember how our Grandmothers cooked things to death? It was partly to make farm-fresh foods safer to eat. Before the mid-1900s, eating raw foods wasn’t common and even people who lived on farms ate very little fresh produce, said Dr. Robert Buchanan, senior science advisor to the Center for Food Safety and Applied Nutrition of the Food & Drug Administration.

Every cook knows that fresh poultry can carry bacteria and needs to be handled and cooked properly. While media gives the impression that poultry is more dangerous than ever, that’s not necessarily so, said Dr. James Denton, Ph.D., Dept of Poultry Science, University of Arkansas, Fayetteville. We are, however, probably more aware of the risks with today’s increasingly accurate testing and diligent surveillance, he said.

Campylobacter (Campy) is a widespread germ that lives inside healthy chickens and is found in much raw poultry. While it’s the leading cause of gastroenteritis in the United States, according to the Centers for Disease Control and Prevention, it’s also a pretty weeny germ, doesn’t keep multiplying on the meat and is easily destroyed by heat. (The germ counts may even wimp out with freezing, some studies are finding.)

Interestingly, while we’re being led to fear Campy in poultry, half of all food-borne Campy infections have been traced to raw milk, according to the CDC. So there are very simple things we can do to protect ourselves and our loved ones. Few of us eat uncooked poultry, and wisely so, but it is every bit as important to avoid raw milk.

Even so, the CDC reported this past April that since 1998, the rate of Americans getting sick from Campy has dropped 30% to 12.68 cases per 100,000 people, according to Dr. Richard Raymond, food safety official at the U.S. Department of Agriculture. That’s partly due to multiple strategies that have been implemented in agricultural practices, processing and retail handling to control contamination from a number of germs, such as salmonella. In 1998, the food industry adopted a mandatory science-based, food safety preventative management system for meats and poultry, called the Hazard Analysis Critical Control Points (HACCP).

Not to downplay the importance of food borne pathogen control because it is being taken quite seriously, but many food, infectious disease and agricultural experts are questioning the methodology and interpretations of the data in the Consumer Reports article. As you can imagine, it’s incredibly easy to vary findings depending on collection methods, what products are selected, their age, packaging, storage and what is tested for. Its worrying findings are quite different from other larger, more comprehensive studies. The extreme increase in contamination levels they reported is also uncertain, given they didn’t test samples from the same stores as in 2003. The USDA’s tests have recently identified only 11% of the chickens it tested as positive for salmonella, compared to 16% last year.

The prevalence of Campy and salmonella are also being tracked by the National Antimicrobial Resistance Monitoring System, a joint project of the USDA, FDA and CDC. Compiling the data from all of their laboratories, they reported about 48% of the samples had detectible levels of Campy. And a large USDA study led by Dr. Norman Stern, a microbiologist at the Poultry Microbiological Safety Research Unit in Athens, GA, showed only 26% of the chickens sampled had any detectible level of Campy. This much larger study was conducted over 13 months and included 4,200 samples. It’s believed to be a much more definitive study than the Consumer Reports paper which looked at only 525 selected samples.

But simply detecting the presence of Campy or Salmonella organisms is not a measure of disease risk, said Dr. Stern. Also not all species cause disease, so generic testing for Campy, for example, that doesn’t differentiate the types could overestimate the risk, he said. “Consumer Reports confirmed that its study did not conduct counts of bacteria cultured from its samples nor serotyping to identify those isolates of campylobacter or salmonella known to cause disease,” reported Feedstuffs.com

Research is ongoing to understand and reduce the risks of these pathogens. Campy is a difficult organism to isolate and culture, and there are difficulties with consistency and accuracy of today's measures for determining risk, said Dr. Denton. A large study involving 25,000 samples, examining 4,200 gene sequencing to better determine the risk potential is currently underway, which should offer some of the best evidence-based science yet, which the food industry can use to better protect us.

In the meantime, is there need for alarm?

While special interest groups mount fears of a problem with inadequate safeguards and want us to believe that nothing is being done to keep our food safe, that is not the reality. Certainly not for the thousands of people devoting their careers to food safety. But the body of the most careful evidence continues to indicate our food supply is the safest in the world and is the safest we’ve ever enjoyed in the history of our country.

It’s so easy, surrounded by today’s scary claims, to forget that as recently as 1900, 40% of Americans died from infectious diseases, and diarrhea and enteritis was the third leading cause of death in the U.S.

©Sandy Szwarc 2006

Click here for complete article (and single page version).

The battle over our children

A recent post discussed the unsound “healthy” school lunches being proposed by special interest groups here in America. Similar recommendations are popping up in England, where parents are speaking out and fighting back:

The battle of the lunchbox

Parents are quite capable of feeding their children - despite what the government's School Food Trust would have us believe. It’s bad enough having Jamie Oliver telling us how to feed our children without another celebrity chef joining in....

The School Food Trust is yet another government-knows-best initiative set up to propagate myths about diet and intervene into areas where government should fear to tread. It’s website states as fact the horrors of the epidemic of obese children. In fact, the level of obesity is generally overstated and the solutions are generally worse than the ‘problem’.

The one thing we do know is that people are living longer and healthier than ever before. The mortality rate for five year olds fell by 98 per cent from 1901 to 2001. In 1901, the UK average life expectancy was 46 years for men, and 50 years for women. In 2001 this had risen to 76 years for men and 81 years for women. Hardly doomsday scenarios....

If it sounds like I have a personal axe to grind, I do. In my children’s primary school they have embraced the healthy eating agenda with a vengeance. This includes inspecting the children’s lunchboxes and giving awards to the child who brings the ‘healthiest’ lunch to school, while telling those who have biscuits [cookies] in their box to bring an apple instead.

Author, Jane Sandeman, goes on to share concerns about the “healthy” eating and “need to be thin” messages inundating school children.

...If the lunchbox inspections are bad, the battle for young hearts, minds and stomachs is even worse. When I went to see an assembly that my daughter’s class staged for parents, the tour de force was six year old girls reading their poems about healthy eating. I found myself feeling queasy as they told us about how you must not eat fatty things, because it is important to be thin! The following week there was yet another healthy eating day which involved trying ‘healthy’ foods. Discussing this with friends in the parents forum that I run, it was clear that everyone had their own little horror story to tell of their child’s school cracking down on contraband lunchbox items or brainwashing them about the dangers of their food.

Call me old fashioned but shouldn’t school be trying to develop knowledge and imagination, whether through fantastic literary tales or inspiring science? Why instead are we infecting such young children with an obsession with their bodies?...These messages...imbue food stuffs with moral characteristics - sliced white bread bad, ciabatta good - and it wants to ensure that morality is enforced.

The inescapable “eat right and be fit” messages surrounding American children, discussed in a previous post, were again highlighted this week:

A Houston teacher issued a Biggest Loser challenge to her ninth grade students, giving cash rewards for the greatest losers. As she was weighing the measuring the students, she told reporters she believes she is educating them on healthy eating. The Houston Chronicle reported: “Although she admits her homemade weight-loss program needs a few tweaks...Last week a 14-year-old weighed in at 105 — down from her starting weight of 114.”

And Iowa Public Television is getting ready to broadcast a program for young elementary school children called “Snow White and the Seven Superheroes.” It teaches that by eating junk food — meat, corn dogs, cookies, caramel apples, hamburgers, and soda — the super heroes lost their power and that children will lose their superpowers and “suffer if they don’t eat healthy.”

Click here for complete article (and single page version).

If it sounds to good to be true...

Healthcare professionals have long sought to change the Dietary Supplement Health and Education Act (DSHEA). The pharmaceutical and weight loss industries have realized it is in their best interests to do so, too. While they educate the public on the ineffectiveness and possible dangers of these unregulated (and competing) products, some valuable information is coming out of the debates.

As the founder and director of a weight loss center told NBC’s Today Show viewers on November 13th, “Americans spend $1 billion on non-prescription weight loss products and none of them work.”

[This figure doesn’t even include the prescription ones, weight loss programs and surgeries!] The news segment went on to report:

Recent studies show that two thirds of Americans think that the government requires warnings about the side effects of these products and about half believe that the U.S. Food and Drug Administration (FDA) has approved these products’ safety and efficacy. Both are not true.

Advertising of these products is often misleading. At best, you simply waste your money. At worst, the products can be unsafe and damage your health....

The unproven claims of products that tout quick weight loss may be unethical, but they are not illegal. These products are usually a bad idea either for your health, wallet — or both. But if you insist on taking them, at the very least, make sure the manufacturer provides an 800 consumer phone number you can call to ask questions about the product’s documented safety and purity. If you’re on prescription medications, check with your doctor before taking these products to avoid harmful interactions. Most of all, remember, when it sounds too good to be true, it probably is.

The Los Angeles Times just published a special report examining the dubious health claims of over-the-counter health products and how to spot them.

THE HEALTHY SKEPTIC

...[M]any of us are happy enough to believe in the healing powers of magnetic bracelets or infrared lamps. And just a couple of years ago, people flocked to buy Seasilver, a big-selling blend of seaweed, aloe vera and other herbal ingredients that was purported to cause permanent weight loss while curing AIDS, cancer, anthrax and nearly 650 other diseases — enough to make the Revigator look like a sugar-pill dispenser.

Health products have changed over the decades, as have many of the buzz words they use to lure customers: Today's products are more likely to "harmonize" and "optimize" than to "revigorate" or "revitalize." They've also updated their sciency-sounding claims...

Since the FTC and the Food and Drug Administration don't have enough resources to go after every product sold under false pretenses, [Matthew ] Daynard says, it's largely up to consumers to protect themselves and put deceptive marketers out of business....Staying vigilant is hard work because it goes against our basic human instincts, says Joe Nickell, a senior research fellow with the Committee for Skeptical Inquiry who has investigated bogus Mexican cancer clinics and other forms of quackery. The deep desire to feel better can easily push aside questions and doubts, he says. "Quack treatments appeal to emotions. People stop thinking with the organ above their neck. They think with their heart or their gut."

We may know more about health and medicine than previous generations, but all of that progress hasn't dampened our wishful thinking, especially in the face of illness, Nickell adds. "A little voice may tell you that it's a long shot, but you put that voice aside," he says....

The article goes on to include a guide for how to recognize quackery, including in weight loss products, and how consumers can protect themselves from being hurt. We can never put our guard down, though, even when we hear about tried-and-true weight loss methods and recommendations to look for products manufactured by large pharmaceutical companies.

Click here for complete article (and single page version).

Antioxidants fail again

The results of the Women’s Health Study continue to come in. The latest, examining the effects of long-term vitamin E supplementation on memory and cognitive function, was just published in the Archives of Internal Medicine.

This 15-year project is one of the largest prevention studies of its kind and the clinical intervention part is a randomized, double-blind, placebo-controlled clinical trial of 39,876 healthy women followed for just over a decade. Previously posted, were the results finding this strong antioxidant to be of no benefit in protecting women from cardiovascular disease, stroke or cancer; and the results that it offered no benefits for preventing type 2 diabetes.

This new report found that long-term vitamin E provided no benefits in improving the women’s cognitive function or memory.

Click here for complete article (and single page version).

Medical Grand Rounds

The latest issue of Medical Grand Rounds has just been released, filled with the best of the medical blogging. It’s at Treatmentonline.com.

To the medical review board, thank you for including your kind review of this blog!

Click here for complete article (and single page version).

“Obesity Paradox” #2— How can it be a disease if it has health benefits?

“Obesity paradox” is a funny term when you think about it. It’s only a paradox — that fat people generally live longer than thin people — because it runs contrary to what a lot of people have come to believe. All we hear nowadays is that being fat is a disease and virtually every health problem experienced by fat people is somehow uniquely horrific.

So, you probably didn’t hear about the study, published in this month’s journal Hemodialysis International, led by Kamyar Kalantar-Zadeh, MD, PhD, MPH, of UCLA David Geffen School of Medicine. It reported that among dialysis patients, “obese” patients are far more likely to survive than smaller patients. Since dialysis patients have protein-energy malnutrition and inflammation, termed Kidney Disease Wasting, obesity probably represents better overall nutrition and protective reserves that lower their risk of death, said Dr. Kalantar-Zadeh.

According to these doctors, the popular belief that fatness is associated with heart disease among these patients has not been shown in any study, nor is the survival advantage of higher BMIs (body mass index) related to having greater muscle mass over fat. Fatness isn’t the only “paradoxical” association among favorable clinical outcomes of dialysis patients, they said in a 2005 issue of the American Journal of Clinical Nutrition:

High concentrations of total cholesterol have been associated with both a survival advantage in these patients, as has an inverse relation between blood pressure and outcome. These consistent findings across an array of cardiovascular risk factors in dialysis patients support the more inclusive term “reverse epidemiology.”

Reverse epidemiology has also been observed in heart failure patients, elderly persons, and patients with advanced malignancies, AIDS, and other chronic diseases. This means that 20 million persons—including almost half a million dialysis patients—in the United States alone may be subject to this reverse epidemiology. We believe this vulnerability to reverse epidemiology could have very important implications for public advice on health matters, because conventional recommendations for the management of CVD risk factors, such as weight reduction or aggressive treatment of hypercholesterolemia, may not be appropriate.

It’s probably shocking for some to hear that there even ARE health benefits to being fat. But as these doctors noted, kidney disease isn’t the only health problem where studies have shown that being fat appears protective and beneficial, especially as we age. It also includes infections, cancer, lung disease, heart disease, osteoporosis, anemia, high blood pressure, rheumatoid arthritis and type 2 diabetes.

“Both U.S. government and Swedish studies indicate that fatness is not associated with increased doctor visits, medical procedures or hospitalizations...Fat men took no more days of sick leave...and were no more likely to have work-limiting health conditions,” wrote Drs. Paul Ernsberger and Paul Haskew in The Journal of Obesity and Weight Regulations. Among those over age 60, “‘obese’ men and women are no more likely to suffer from chronic diseases than ‘average-weight’” persons.” But they are more likely to survive longer. (Yes, even when researchers have factored for weight loss that could be a symptom of late-stage cancer and other pre-existing illnesses that could make thinner groups appear less healthy.)

The Seven Country Study, for example, which has followed 13,000 men over the last 40 years, has found that the risks of dying from cancer and infections decrease with increasing weight. In long-term prospective studies, complications (like retinopathy) and mortality rates from type 2 diabetes are three times lower among heavier people. And people are much more likely to survive a hospitalization if they’re “overweight” than if they’re thin.

Not that any illness is entirely benign for any weight, but given the more favorable course among fat people for many conditions, it’s sad that it’s a perspective that has become lost in today’s popular discourse.

© Sandy Szwarc 2006

Click here for complete article (and single page version).

Feeding our children well

A recent post mentioned the growing body of research showing obesity fears and “healthy eating” messages have taught children that low-calorie and fat-free foods ARE good nutrition. Even adults, especially women, have come to believe low-fat, low-calorie (and low everything) means healthy eating. But a story in the news today demonstrates how extreme the fears of fat have become, not only among parents, but even degreed professionals caught up in the anti-obesity frenzy. It points to very real dangers possible for their children and others following their example.

The Rudd Center for Food Policy and Obesity at Yale awarded a mother from South Jordan, Utah, $1000 for coming up with “A+Lunches” — ideas for parents to give their preschool and school children to “battle the ‘global obesity epidemic.’”

It is typical of the menus increasingly being recommended by anti-“childhood obesity” activists. The lunch includes no sweets, no meat and no “fattening” foods, only foods believed to be “healthy”: carrot and celery sticks, a few apple wedges and berries, a small dollop of peanut butter between flower-shaped pieces of bread, and skim milk. The mother tested it on her four-year old.

A brief nutritional analysis of this lunch menu revealed that it supplies less than 20% of the energy needs (calories), dietary fats and iron recommended even by the government’s Dietary Guidelines for a typical four-year old, let alone an older school child. It demonstrates the increasingly overzealous adoption of “healthy” diets, arising from the belief that if a little restriction of “bad” foods is good then more is better.

But unbeknownst to most parents, such diets not only have no sound evidence to support them, but they have been shown to result in harm to children’s health....

Sadly, most parents today are probably unaware of the controversy that’s raged in the medical community for more than two decades over the lack of evidence and potential harm of recommendations to restrict fats and sugars in children’s diets. [Not to mention the same situation among adults’ diets.] Let’s take fat as an example.

While there is great concern among public and private anti-obesity groups about the apparent excessive amount of fat our children are eating, that’s not what the government’s dietary statistics show. The total fat intake of kids is currently about 32%. That is well within even the 25-35% recommended for children by the 2006 Dietary Guidelines. So the tremendous energies and initiatives being undertaken to get children to eat “healthier,” low-fat diets are based more on fear marketing than facts.

Still, even the government's recommendations are controversial. While the National Cholesterol Education Program, American Academy of Pediatrics, American Heart Association and various official-sounding sources advise restricting children to 30% of their calories from fat, many health professionals have voiced concerns about both the effectiveness and safety of applying these adult recommendations to children. They believe evidence should be behind such advice.

A comprehensive examination of the evidence surrounding dietary fat for children was conducted by researchers for the American Society for Nutritional Sciences. They scrutinized the role of dietary fat in the growth, development and long-term health of children and presented their findings at a workshop held September 17–18, 1997 in Bethesda, Maryland. They found that researchers have repeatedly tried and failed to demonstrate benefits from lower fat diets beginning in childhood. Their report states that the focus on fat and the nutritional messages to limit fats are unhelpful and actual causing harm.

The disparagement of dietary fat sometimes obscures the fact that children and adults need fat in their diets.It supplies essential fatty acids and aids in the absorption of fat-soluble vitamins A, D, E and K. It is a substrate for the production of hormones and mediators. Fat, especially in infancy and early childhood,is essential for neurological development and brain function. Mother's milk and infant formula supply 40–50% of their energy as fat.

Another review of the science by researchers at the Center for Food and Nutrition Policy at Georgetown University School of Medicine, noted that low-fat diets have never been proven to be beneficial and potentially could be unsafe for children. Robert E. Olson, MD, PhD, of the Department of Pediatrics at the University of South Florida, wrote of the dietary fat obsession of public health professionals. Their “most irrational” recommendations for the population, he wrote, are those restricting fats, cholesterol and added sugars. They are to such low numbers they “in effect, eliminate a large number of foods...The goal is ostensibly to prevent atherosclerosis and cancer,” he said, but that belief has “not been demonstrated in any of the many clinical trials conducted in the United States and Europe.” His review of the evidence, published in an article titled “Folly of restricting fat in the diet of children,” concluded:

On balance, the risks of lowering the fat and cholesterol content of children diets so outweigh the benefits as to totally invalidate the recommendation of the expert panel of the NECP and the 1992 Committee on Nutrition of the AAP. Although it is clear that many children consuming diets containing 30% of calories from fat will not suffer growth failure if their energy content is adequate, the idea of promoting low-fat diets for all children without evidence of benefitwill increase the risk of malnutrition in some of them.

Since it may be possible to get sufficient nutrients with closely supervised low-fat diets, some believe that means recommendations for everyone are supportable. However, in reality, the number of cases of children not getting sufficient calories and nutrients as a result of their parents imposing low-fat diets are being reported in the medical literature with troubling and growing frequency. The concerns go beyond the risks already discussed on this site, such as eating disorders, health problems and tripling the risks for later developing obesity.

For years, pediatric specialists have cautioned:

Expert panels recommend reduction of dietary fat and cholesterol, because excessive fat intake may lead to known health hazards....The results of such diets may be suboptimal growth and development.

Since 1980, Dr. Fima Lifshitz, MD, and colleagues at the North Shore University Hospital in Long Island have been identifying children with short stature and delayed puberty, “mostly from affluent families, as a result of fears of obesity and the desire to be slim.” The parents aversion to fat was so strong that even when they were told of the need for their children to eat more, “some parents were reluctant to offer more food.”

Among children showing non-organic (no medical reason) failure to thrive, researchers find the problem is often rooted in the mother’s own fears of fat and belief in “healthy” eating. Mistakenly, the parents believe they can prevent their children from becoming fat. A study by doctors at the Park Hospital for Children in Headington, found most of these children were being fed what the parents called “healthy” diets, but which were, in fact, too low in energy and fat. Half of the mothers were restricting their children’s intake of “sweets” and another third were restricting foods they considered “fattening” or “unhealthy.”

Michael T. Pugliese, MD,Nassau County Medical Center, Division of Pediatric Endocrinology in New York, is another researcher who’s reported on the harmful effects of restricting calories and fats in children. In one evaluation with Dr. Lifshitz, nearly 10% of growth-retarded children they saw were the result of the parents fearing their children might become fat. All of these children had “deteriorating linear growth... preceded by at least 1 to 2 years of inadequate weight gain.”

Children are high energy little beings and they benefit from fats and sugars to supply all of the energy they need. Their little tummies can’t fit in enough calories eating low-fat, low-calorie foods.

But what about heart disease?

While there is no scientific evidence to support beliefs that restricting dietary fat can reduce childrens’ risks for heart disease, cancer or other chronic diseases as adults — or that childhood diets even influence adult eating habits — such beliefs continue to be popular.

Most parents would be surprised to learn that recommendations to reduce fat in children’s diets are based on findings on middle-aged men at high risk for heart disease. The few studies that have been done on children have found that a fat-restricted diet has little or no effect on blood cholesterol levels, even among children with high cholesterol. More worrisome, is that some evidence suggests these diets could pose greater risks for heart disease in adulthood.

The American Society for Nutritional Sciences’ review found no evidence linking childhood nutrition to heart disease in adulthood, for instance. They found that many of the correlations reported proved to be weak and “provide little support for drawing firm causal inferences...childhood serum cholesterol values do not predict adult levels very well.”

An additional point is worthy of note. That lunch menu recommended by Rudd Center supplied only about 1.75 mg iron, considerably less than the RDA of 10 mg for toddlers and preschoolers. It exemplifies the concerns highlighted by researchers at North Shore University Hospital, Manhasset, NY, surrounding popular fears of animal products, which often accompany fears of obesity. They found lower fat diets that avoid or severely limit animal products may not supply enough energy or micronutrients such as iron, zinc and calcium to support normal growth and development in children. Plant sources of iron are absorbed by the body at about 5%. In contrast, meat, chicken and fish (heme iron) is absorbed at 15-30%. Even though vitamin C improves absorption of non-heme iron, it is decreased by calcium-rich foods children need, such as milk. Children getting primarily non-heme iron, in the real world, are at high risk for iron-deficiency anemia.

Voices of reason

When pediatric nutrition and health experts recognized that children were not just little adults and had special nutritional concerns, Health and Welfare Canada with the Canadian Paediatric Society formed a working group to weigh the evidence. They considered children’s nutritional needs for growth and development, as well as dietary influences on adult-onset disease. They found that “there is no evidence that implementation of a diet providing 30% of energy as fat... would reduce illness in later life or provide benefit to children as children.” They noted considerable evidence showed that low-fat diets left children short on nutrients as well as calories to supply the energy they needed.

Their conclusions in a scientific statement just released this past February, were that foods should not be restricted or eliminated because of fat content during the preschool and childhood years. Only after linear growth has stopped, should adult recommendations be applied. A gradual tapering from 50% at age 2 to 30% by adulthood was advised.

This information is so contrary to everything we hear anymore, it’s no doubt unsettling to learn. But exploring all of the best evidence-based information available can only help us make the best choices for our children.

© Szwarc 2006

Click here for complete article (and single page version).

A "very toxic environment:" No, not that one!

Yet another children’s hospital reports escalating numbers of children requiring hospitalization for eating disorders resulting from trying to be thin and their growing fears of food.

Slimming crisis hits pre-teens

THE number of Victorian children with anorexia has skyrocketed, with experts blaming advertising, celebrity magazines and the nation's obsession with obesity. The Royal Children's Hospital has recorded a surge in the number of children under 14 with the disease this year, treating more than 10 times the cases it handled in 2003. Some of the children are only eight. Three years ago, the hospital treated three children under 14 with the illness. So far this year, it has diagnosed 35...

Part of the problem is the huge emphasis we have on dieting and what children perceive they should look like," said the foundation's [Eating Disorders Foundation of Victoria ] Frances Saunders.

The role model for primary school students, she said, was Paris Hilton. "This ideal of the perfect thin person is very pervasive among young people."

Rick Kausman, the Australian Medical Association's spokesman on weight management and body image, blames peer group pressure and society's obsession with obesity. "We are living in a very toxic environment," he said."There is so much focus on weight and body. In our attempt to help kids to be moderate in their eating, we are creating this fear so teenagers are denying themselves food that is normal to have....

Photo source: THIN

Click here for complete article (and single page version).

Junkfood Science Weekend Special: Why are we surprised?

The news recently reported:

Anorexia begins at five

[Australian] children as young as five are being diagnosed with anorexia as experts blame stress and a national obsession with obesity for a shocking rise in the number of NSW youth being treated for the illness....Since 2001 there has been a 20 per cent rise in the number of children younger than 18 being admitted to the hospital with anorexia....

Dr Kohn said the hospital [Children's Hospital at Westmead] was now treating children aged between 7 and 11. In children that young, anorexia is as common among boys as it is in girls although, after 12, females are at least 10 times more likely to develop the illness. The physical impact of the disease is much greater on pre-pubescent children because the malnutrition coincides with the period of peak growth and development.

Television shows, cartoons, websites, games and toy figurines had promoted a "thin" ideal among children, Dr Kohn said. A focus on the obesity epidemic could also fuel eating disorders.

Eating Disorders Foundation executive officer Greta Kretchmer said the focus on obesity and eating the right food had created a backlash. "When you have some people who have perfectionist tendencies, it leads to them trying to do it too well by cutting out all fats, all carbohydrates, all dairy," she said....

It may seem unimaginable that such young children have become so frightened of getting fat and are afraid of their food and to eat. But it really isn’t when you stop to realize what they are being taught.

Even preschoolers cannot escape the nonstop barrage of “eat right and be fit” messages that have been instituted to address “childhood obesity.” Saturday morning cartoons are now devoted to these themes, such as Nickelodeon’s “Lazy Town,” PBS' “Boohbah” and the Disney Channel's “JoJo's Circus.” Ronald McDonald is pushing fitness and even the Cookie Monster on Sesame Street and Barney tells kids about eating “right” and that his favorite treat should only be a “sometime food.” Children’s programming is filled with examples of the fat children being made fun of and ridiculed.

Across the country, there are programs for toddlers to teach them “the importance of good food choices, the right portion sizes and exercise,” such as Trim Tots in Des Moines, Iowa. And even fitness centers have opened to “prevent” children from becoming fat by teaching them “about healthy diet and working out,” such as My Gym in Maine for children 6 weeks of age through 6 years.

Today’s children can’t escape these messages when they go to school, as they’re pumped into every classroom on Channel One, cafeterias are papered with eating right charts, they count calories in math class and calories in gym class, and in many schools they’re weighed and graded on how they measure up.

Considering just the extremes of diagnosed anorexia, which is in itself life-threatening with the highest mortality of any psychological illness, overlooks even larger concerns emerging from this environment....

It is not only anorexics who are restricting and cutting out vital calories, fats, carbohydrates, dairy and meats from their diets. Almost half of all first graders and 90 percent of high school girls are already dieting, afraid of getting fat and afraid of foods. A disturbing study by researchers at the University of Illinois, Urbana-Champaign, found that weight control and “healthy eating” messages have taught children that low-calorie and fat-free foods ARE good nutrition. Lots of adults believe that, too.

According to NHANES III (National Health and Nutrition Examination Survey), at least two-thirds of weight-conscious teenage girls, fat and thin, trying to eat “healthy” are now deficient in iron, calcium and other important nutrients. “Many teenage girls, already the most poorly nourished of any group in America, have stopped drinking milk or eating meat in their extreme fear of fat,” said Frances Berg, MS, author of Women Afraid to Eat. Children are also especially vulnerable to ideologies and scares of dangers promoted by various special interest groups and have come to believe that many foods, such as animal products or non-organic foods, are bad and harmful.

International child nutrition and eating expert and researcher, Jennifer O’Dea, MPH, PhD, from the University of Sydney in Australia, cautions that when working with young people, “negative messages such as sugar and fat are ‘bad,’ and use of the term ‘junk food’ contribute to the underlying fear of food, dietary fat and eating problems.” According to her research, health education messages and government dietary guidelines since the 1970s, with their “control your weight” messages, have resulted in an exponential rise in disordered eating and most young people have mistakenly come to believe that what is actually dieting is eating “healthy.”

“Positive nutritional messages” — as well-intentioned and intuitively correct as they may seem — are not benign. But in the inflated panic over “obesity” and need to eat “right,” we almost never hear the downsides. Never mind the problematic quality of the scientific evidence used to support many popular nutritional teachings.

Increasingly, childhood weight and eating experts are cautioning that nutrition rules are beyond children’s understanding and do not consider children’s mental and emotional development. Children cannot grasp the complexities of dietary guidelines, which most adults don’t even comprehend. The messages children take away are largely negative. Children are black-and-white thinkers and highly impressionable. When certain foods, such as fat, are restricted or they are told to eat them in moderation, they take it to mean all fat is bad. This problem with what children take away from even “positive” nutritional information was identified more than ten years ago. The 1995 Gallup Food, Physical, Activity & Fun: What Kids Think Survey, for instance, found that more than four out of five (81%) children between the ages of 9 and 15 thought eating healthy meant avoiding all high fat foods. And this phenomenon isn’t just in young children. A study of college-age girls published in the Journal of Consulting Clinical Psychology found many had come to think of fat as evil and an analysis of their diets showed they were dangerously eating only 4% fat.

Dieting, let alone any diet that eliminates or restricts certain foods or food groups, can pose very real threats to the health of children and young people. And the size of the children is irrelevant; children of all sizes are affected. Many children are falling short of nutrients needed for normal growth that are supplied in “fattening” foods. A 1996 study in the Journal of Adolescent Health examining women 14 to 19 years of age, found a high prevalence of inadequate energy, protein, calcium, iron and zinc intakes among young vegetarians as compared to their counterparts who consumed animal foods. According to research from iron metabolism expert, Nancy C. Andrews, M.D., Ph.D, 20 percent of women of childbearing age and many children were at risk of iron deficiency anemia, especially those not eating meat.

“Low-fat” is a common theme in “healthy” eating messages. While there is evidence that restricting fat before age five could be dangerous, there’s little evidence it may be beneficial. This holds true even for older children. A study of more than 14,000 American children by researchers at the University of Nevada found that kids eating low-fat diets have lower intakes of vital nutrients — calcium, phosphorus, magnesium, iron, zinc, fiber, most B vitamins, vitamins A and C and folate — compared to kids eating high-fat diets or a variety. And the Bogalusa Heart Study, which has followed more than 1,500 children in Louisiana since 1973, has found that those with low-fat diets were nutritionally inadequate in a number of vitamins and minerals needed for optimum growth and development, as compared to kids eating high-fat diets (>40% of calories).

The risks of insufficient calories and nutrients for children are well established in clinical studies, stunting physical and mental growth and development, and contributing to long-term health problems. Self-imposed dietary restrictions among otherwise healthy pre-teens in extremes can even slow puberty by half and delay bone age by as much as 5 1/2 years. Among male teens, growth retardation is a key characteristic of anorexia and a study in the February 2003 issue of Pediatrics found 75% of them never achieve their full adult height.

Of equal concern is the compelling body of evidence showing that restrictive eating and trying to control calories and eat “healthy” (or dieting) greatly increases young people’s chances of developing full-blown, life-threatening eating disorders, as well as suffering from life-long struggles with food.

For example, a 3-year study published in the British Medical Journal concluded: “Dieting is the most important predictor of new eating disorders.” It found adolescent girls, regardless of their weight, dieting at just a moderate level are five times more likely to develop an eating disorder, with one in 40 developing an eating disrder after one year of dieting. And serious dieters are 18 times more likely to develop a new eating disorder within six months — one in five.

According to researcher and clinician David M. Garner, Ph.D., director of River Centre Clinic in Sylvania, Ohio, and adjunct professor at Bowling Green University and the University of Toledo:

One of the most important advancements in the understanding of eating disorders is the recognition that severe and prolonged dietary restriction can lead to serious physical and psychological complications. Many of the symptoms once thought to be primary features of anorexia nervosa are actually symptoms of starvation.

Look at that list of warning signs of an eating disorder in that news article above. You’ll be struck that they are not only the signs of the extremes of anorexia, but most are identical to the behaviors and experiences common among dieters, encouraged of fat children to lose weight, and often recommended and acceptable for everyone to “control” or “manage” their weight.

© Sandy Szwarc 2006

Next Weekend’s Special Feature: The faces of eating disorders not seen in the media.

Click here for complete article (and single page version).

When fear spreads

Just yesterday, after watching a human biology film, an entire class of school children in Barnsley, South Yorkshire, one after another, became faint and nauseated. Thirty-two children and their teacher were taken by ambulance to the hospital and the entire school was evacuated as a precaution, while environmental and public health officials combed the building to determine the cause. Meanwhile, doctors did careful examinations and tests on the children. They could find nothing physically wrong with the kids and the building checked out okay, too. It turned out to be another case of mass hysteria. The Times reported on it today.

This episode occurred just weeks after another case in Monrocia, Liberia West Africa on November 20th. Sixty girls and a teacher at St. Teresa’s Convent, “amidst wailing and screaming with inexpressible grief,” were reported to have been struck by seizures “that left them fainting, with foam in the mouth.” The intense alarm and fear that swept through the community led Dr. Benjamin Harris, MD to write an article last week explaining mass sociogenic illness in the Liberian Observer.

If these sensational stories sound like the antics of mischievous, easily-impressionable or disturbed children, you may be surprised to learn that mass hysteria is a very real phenomenon and that more than 200 cases have been documented in the medical literature. Countless examples have also occurred throughout history. But most people have probably never heard of them.

Last week I wrote about how the placebo and nocebo effects were at work in most of today’s popular beliefs surrounding good-bad foods and alternative modalities. “Collective delusions” is the term that sociologists and psychologists give to the phenomenon of false or exaggerated beliefs and fears consuming a group of people. But for those emersed in it, it is not a delusion. Their personal experiences are very real.

Even when we’re told, or know, there is no scientific basis for what we’re experiencing, it’s still hard to believe that our minds can be that powerful.

“Mass hysteria,” also called “mass psychosomatic reaction” or “mass sociogenic illness,” is an epidemic of physical symptoms without biological basis that spread through a group of people, often young women, who share certain beliefs about their fears and symptoms. The physical symptoms of illness in an outbreak can be extremely varied and frightening. They come on quickly after exposure to a believed threat and spread fast merely by suggestion: watching or hearing about it. And the symptoms can disappear just as quickly. With the internet, mass hysteria spreads far more quickly and far beyond the regional clusters of the past. Mass hysteria can take hold of anyone. Even 300 nurses at a London hospital were once overcome by mass hysteria, experiencing paralysis!

The U.S. Centers for Disease Control and Prevention investigated and described an outbreak of mass sociogenic illness that occurred among 150 children, mostly girls, at a summer program in Florida. The symptoms began shortly after lunch and included stomach aches, nausea, headaches, dizziness, sore throat and vomiting. The children were rushed to the emergency room and underwent thorough physical exams and tests. The lunch foods were tested for any possible contaminant, the food preparation and storage was checked, and the facility was scrutinized by public health officials for any exposure. Nothing physical could be found. The CDC notes that the rapid onset and disappearance of symptoms, the lack of physical findings, the preponderance of cases in females, and the absence of a laboratory-confirmed etiologic agent are consistent with mass sociogenic illness.

There was a mass hysteria episode in 1998 where 800 children in Jordan believed they had been poisoned by their tetanus-diphtheria vaccinations and 122 ended up requiring hospitalization. Kids here have been victims after being prompted by the suggestion of fumes. In fact, none of these children had actually had an exposure.

At the core of these traumatic episodes is fear and anxiety of unseen dangers. And goodness knows, fear is the marketing tactic of today and a favorite among junk scientists. Doctors at Children’s Hospital of Pittsburgh recently cautioned that as fears increase, such as those concerning bioterrorism, the frequency of these episodes will increase, which in turn will create and build more anxiety.

Because the illness symptoms of these extreme cases initially mimic bioterrorism, infection or acute toxic exposure, it can be challenging for medical professionals and the community to recognize what is going on. However, mass hysteria is exacerbated when people over-react — such as teachers, parents, media, doctors and public health officials — making it especially important to quickly identify and explain what is happening, inform everyone of the negative laboratory and environmental tests (which sadly, aren’t always believed), and try to prevent it from spreading.

The Canadian Medical Association Journal noted that these events are far more common than is believed. Besides disrupting lives and communties, they place enormous burdens on emergency and public health services.

A good overview is a physician’s guide written by Dr. Tomothy Jones, MD with the Tennessee Department of Health in Nashville and published by the American Academy of Family Physicians. They also offer a printable, consumer-friendly handout on Mass Psychogenic Illness to help families understand it and learn what they can do.

Click here for complete article (and single page version).

Science versus Superstition

The Policy Exchange, a think tank in England, just released Science vs Superstition: The Case for a New Scientific Enlightenment (2006). It’s a collection of opinion essays about scientific inquiry and the rise of “superstition over science.” Not light reading, but it offers a brain work-out for those interested in exploring topics, albeit controversial, in today’s public debates.

It’s a free download.

Here’s just a taste:

In contemporary Western society we live longer and healthier lives than in any previous historical period. Science in the 21st century promises even greater longevity and health.

It may seem paradoxical, then, in a period when science promises so many great and exciting contributions to humanity’s future, that we are at the same time beset by a fear, uncertainty, and at times an outright antipathy, towards science; that we are distrustful of the promises science makes, and fearful of the risks it throws up and of the consequences of scientific intervention in the world around us...

Of course, scientific discoveries have always raised controversy, and the social changes such discoveries have engendered have always been as likely to throw-up opponents as supporters. But those who oppose science today are very different from the kinds of groups and individuals who objected to scientific developments in the past...

Just as today’s opponents of science come from very different perspectives than former opponents, so too is the form and substance of their arguments historically novel. The arguments which do most to undermine our belief in science today often present themselves not as opponents, but as proponents of science. ...[but are] selective in their use of science, and their interpretation of the scientific data is equally determined by pre-conceived political agendas. Further, the form of their arguments is not a critique of science as such, but simply a call for greater precaution and greater external, extra-scientific regulation in the name of “ethics,” Both approaches, however, ultimately serve to breed a mistrust of science.

Ultimately, the problems discussed in this book are not limited to science. Mistrust of science is an expression of a more fundamental mistrust of ourselves as human beings.

To call for a new scientific enlightenment is not to make a call for a greater faith in science. On the contrary, it is a call that what currently stands as scientific fact must be held up to account, just as much as the current state of science generally must be investigated, challenged, and criticised. The chapters in this book are an attempt to begin that process.

Calling for a new scientific enlightenment means, ultimately, calling for a greater faith in the human spirit and in the capacities of human beings to investigate, to know, and, - where we decide it appropriate - driven by our expanding knowledge and guided by reason and the search for truth, to change the world in which we live for the better....

As a final observation, suggests that the precautionary coalition has a paternalistic, even anti-humanist, perspective on society, its citizens and its economies. The perspective is one that assumes that once we have begun to engage in a direction that might lead to undesirable outcomes, we will be unable to stop, or to make choices between good and bad outcomes. It is the possibility of human action in the world for human betterment that the precautionary principle throws into doubt. It is scientific activity itself about which the principle calls upon us to be precautionary....

The supporters of the precautionary principle are moving on a slippery slope by trying to impose the ancient ‘wisdom’ – better to be safe than sorry – over scientific knowledge, as the guide to our actions.This is really a call to move away from conscious knowledge, information, education, ethics of responsibility and the capability for judging freely, towards the unconscious and the ultimately uncontrollable.

Click here for complete article (and single page version).

Junkfood Science exclusive: A time for joy and nurturing

Pregnancy and new motherhood is one of the most stressful and anxious times for most women as they worry for themselves and the innocent lives in their care. This concern means they’re especially vulnerable to becoming alarmed by health scares and to react out of fear, with potentially harmful outcomes. So it is especially imperative that the health information they receive is well-grounded, credible and helpful.

When the headlining story — which appeared virtually verbatim in media across our country and around the world — told women they were putting their pregnancies and unborn babies at risk if they didn’t lose all of their pregnancy weight and begin their next pregnancies at “healthy” weights; weight loss admonitions began instantly. In fact, the researchers whose study this news story was based upon told media that their “striking findings” provided “the evidence that overweight or obese women who plan to become pregnant should lose weight.”

Even a modest increase of 7 pounds, the public was told, could raise a woman’s risk for pregnancy-related complications, such as gestational diabetes by 30% and pregnancy hypertension 40%. But they delivered even more frightening news, warning women that “gaining 3 or more units of BMI (body mass index) raises the risk of a stillbirth by 63%, pre-eclampsia and gestational hypertension by 78% and 76%, and could double her risks for gestational diabetes.”

“These are staggering numbers,” Daniel Herron was quoted as saying. Women should not wait for later research before changing their behavior and losing weight between pregnancies, he added. [Not a single reporter revealed that Herron is not simply an “associate professor of surgery at Mount Sinai Hospital” as they reported. He is Chief of Bariatric Surgery with Mount Sinai’s Program for Surgical Weight Loss, as well as on the Public/Professional Education Committee of the American Society for Bariatric Surgery. Readily-known interests, in promoting fears of obesity and the need for weight loss, the media didn’t disclose.]

Also quoted in the media reports was a reproductive health specialist with the World Health Organization who said: “This is the first study to provide...the necessary evidence to show a causal relationship between obesity and adverse outcomes.”

What is passing for evidence and sound interpretations by health authorities is, in fact, what is most staggering.

What did the study show?

This study was conducted by Eduardo Villamor, M.D., of Harvard School of Public Health and Sven Cnattingius, M.D., of the Karolinska Institute in Stockholm. They sorted through data from the medical records of 151,025 Swedish women who had had their first and second babies during 1992-2001. It was a “case-controlled” study, looking retrospectively through histories trying to find correlations between BMIs and pregnancy complications. The researchers applied statistical modeling of the data to create the odds ratios they reported.

To make any sense of their findings, we must first understand what an odds ratio actually means. See side bar: Odds Ratios.

The first thing you’ve probably noticed is that none of those scary-sounding percentages reported in this study are credible for such statistically-derived findings. We could leave it right there, but a few of the “nonfindings” may further help lessen undue concerns about weight and reveal a few holes no one’s talking about.

These researchers found that risks for pregnancy complications — pre-eclampsia, gestational diabetes, stillbirths and large for gestational age babies — were the same whether the women were fat or not. Being fat didn’t matter.

So, it seems, some statistical maneuvers were necessary to find something to pin on weight.

Most of the women gained on average just over half a BMI unit (0.3 to 1.7) between pregnancies. So women gaining 3 or more BMI units were uncommon and those “staggering” risks we heard for them may have been more reflective of linear projections in the researchers’ mathematical model. At the very least, they greatly inflate the risks for most women

Behind the scenes: ignored factors

To calculate the difference between what the women weighed at the beginnings of their first and second pregnancies, the authors used the weights recorded at their first prenatal visits. However, how far along the women were when they first went to the doctor was unknown! Nor did they have any information on illness or other things that might have affected the women’s weights before seeking prenatal care, or during or after their pregnancies. This is a huge flaw. It alone could easily explain their findings, especially given the minor 7 pound weight differences they’re claiming mean something.

The timing of the first prenatal visit, and a woman’s condition at that initial exam and throughout her pregnancy, could easily be a marker for socioeconomic factors. For instance, women who are poor, minority, with fewer resources, lesser educated, young single mothers, having unplanned pregnancies, or those with substance abuse problems are more likely to delay prenatal care and be further along and therefore, heavier by the time they are first seen by a doctor. According to the March of Dimes, most women gain about 2-4 pounds during the first trimester and about a pound a week for the remainder of a pregnancy.

In fact, socioeconomic factors are evident in the researchers own notes: “Weight gain between pregnancies decreased with age, education...[and] women of Nordic origin." Yet these researchers failed to acknowledge or even consider socioeconomic factors, which are well-documented to be significant in health outcomes. Instead, they pointed to weight.

That is especially puzzling since Dr. Cnattingius’ own research on Swedish mothers published just a few years ago in the International Journal of Epidemiology concluded that it was low socioeconomic status that increased the risk for stillbirth, and none of the other factors they examined were associated with these poor outcomes, including prenatal care, reproductive history, maternal diseases or pregnancy-related health problems such as pre-eclampsia or hypertension.

Even the U.S. Centers for Disease Control and Prevention’s Pregnancy Mortality Surveillance System reports disparities in pregnancy-related mortality in the US., continuing since 1940. Blacks, for example, are four times more likely to die from pregnancy-related causes than are white women. Black women also appear to hold onto their pregnancy weight three times more than white women, as has been reported in the American Journal of Clinical Nutrition.

The higher weights at the beginning of the second pregnancies can also reflect more weight gained during the first pregnancy. Excessive weight gain is a classic symptom of pre-eclampsia (also called toxemia), along with high blood pressure and protein in the urine. Good prenatal care is important to avoid complications. While the causes for pre-eclampsia are unknown and there are no known ways to prevent it, 85% of cases occur during the first pregnancy and it is twice as common in Blacks and four times more common in women with a family history. Yet the researchers didn’t acknowledge these potentially significant factors and untold others. Instead, they pointed to weight.

Finally, like the WHO health expert quoted in the news, they made the most egregious error of all: believing correlations can ever show causation. The researchers said the evidence is compelling and strengthens the argument for causality between weight gain and harm to mother and baby.

It’s that silly “killing turkeys causes winter” argument. If it weren’t for the fact that everyone believes weight is to blame for everything, the fallacy would be more apparent.

They then proceeded to skip in reverse and say that these findings “provide robust epidemiological evidence for advocating weight loss.”

Except this statistical report was unable to even find tangible correlations, let alone any evidence for advocating a preventive treatment. Unless you believe that eating tofu-turkey can lead to eternal summer.

Commentary: For most of human history, fat has been life-sustaining — seen as security against scarcity, and a desirable sign of fertility and ability to bear and nurture children. Pregnancy and childbirth is also a natural time when many women gain weight, and by middle-age most women have about 38% body fat. This has long been recognized, hence, weight recommendation charts were according to age. Fat is necessary for the production of many hormones such as those involved in calcium metabolism, normal growth and development, and fertility. Girls need body fat to begin normal puberty and women to menstruate, get pregnant and carry babies to term. Given the protective, fertility, immunological and nurturing benefits of fat stores, it is not surprising that there is no evidence that midlife weight gain is harmful to healthy women. In fact, most evidence has long shown it to be beneficial. But the unintended consequences of unsound scare marketing about weight gain are very real, and very heartbreaking. Women going into a pregnancy underweight, nutritionally compromised (by poverty, dieting or bariatric surgery), or afraid to gain weight during the pregnancy can compromise their baby’s health and their own.

© Szwarc 2006

Click here for complete article (and single page version).

Study Sidebar: Odds Ratios

Reporting statistical findings are rife with problems. Did you know that in the medical literature, you’ll find researchers taking the same data and coming up with exactly the opposite of the findings reported by another researcher? This demonstrates the problems with different mathematical models and calculation errors...

Health studies rarely give us the actual numbers and how a factor might change our real risks for a disease. While that would be more accurate in giving us a true picture of our probability or risks for a disease (or cure), those numbers almost never sound impressive enough to sell us on the importance of the research.

Most often, we’re given relative risks, which are ratios comparing two groups and their probabilities of a disease. They are fractions, so a relative risk of 1 (1/1) means there is no difference between the groups. If one group has one case of a disease and the second group has two cases, that’s a relative risk of 2.00 for the second group. It’s also an impressive-sounding “100% increase in relative risks!” — but in real life reflects only one additional case.

So a 50% reduction in our relative risks of dying from heart disease sounds awesome. Until you learn that your actual chances are, for example, 0.5%. So a women might lower her actual (absolute) risk from 0.5% to 0.25% — not nearly as impressive. The real (absolute) numbers are important to know.

Still, relative risks are what most of us think of when we’re looking at our chances for getting a disease. But a new way to report risks is becoming increasingly common and is much harder for most of us to interpret: odds ratios. An odds ratio compares odds, rather than actual incidences. As professor John Brignell, author of The Epidemiologists: Have they got scares for you!, has noted, it’s a popular tactic found in junk science because it can exaggerate an apparent effect when there’s really nothing significant. Here’s an example:

If the proportion of boys to girls is even, then out of 100 children there are 50 boys and 50 girls and the ratio (expressed as relative risk) is 50/50 which is 1. If we have one extra boy per hundred, however, we have to have one less girl to make up the total, so the ratio (expressed as odds ratio) now becomes 51/49 or 1.04, a 4% increase. Thus the proportion has changed by 1%, while the ratio has changed by 4%."

When event rates are high (commonly the case in trials and systematic reviews) the odds reduction can be many times larger than the relative risk reduction. These discrepancies in magnitude are large enough to mislead, according to medical statistician, Jon Deeks of the Centre for Statistics in Medicine, Institute of Health Services, Oxford. He explains it this way. Suppose there are two groups, one with a 25% chance of mortality and the other with a 75%. The change is a relative risk of three, but an odds ratio of nine. “A change from 10% to 90% mortality represents a relative risk of 9 but an odds ratio of 81.” Odds ratios may be the best estimates that can be obtained in certain types of statistical studies, such as case-controlled studies, but they still risk exaggerating perceived risks.

Making sense of odds ratios versus risks gets more complicated, but it’s probably more than most of us care to know. To make it easier, we can think of the numbers like relative risks, just keep in mind that their significance can appear greater than they really are. And when we’re reading about odds ratios, it is even more imperative to remember that risks less than 3 (or 200% difference) are untenable for any statistical finding. Now, back to the article....

Click here for complete article (and single page version).

Calling all skeptics

The 49th Meeting of The Skeptics’ Circle is now up at Autism Street.

Thank you, Skeptics Circle, for your recognition of my article, Should we care what works and what doesn’t?

I heard that the entries were channeled through a medium this month. There are great essays skeptics will enjoy— Happy reading!

Webster's Dictionary defines skepticism as:

"A critical attitude towards any theory, statement, experiment, or phenomenon, doubting the certainty of all things until adequate proof has been produced; the scientific spirit."

The Greek root of skepticism is "skepticos,” which means "thoughtful, inquiring."

Click here for complete article (and single page version).

Women dying for size zero figures

“Thousands of young women desperate for a “size zero” figure are putting their lives at risk by taking laxatives in the mistaken belief that it speeds up weight loss,” the Times reported yesterday.

Mintel, the consumer goods analyst, has found that the British market for laxatives is now worth £52 million, up 33 per cent from 2001. The company is in no doubt that desperate slimmers are behind the surge.

“On the flipside of over-eating in Britain, we have seen a pre-occupation with undereating and perpetual dieting,” said David Bird, senior market analyst at Mintel. Experts on eating disorders say laxative abuse is now rife, with young people in particular totally unaware of the huge danger it poses to their health....they rob the body of vital vitamins and minerals, and, most significantly, potassium, which can result in heart failure.”

Research commissioned by the Eating Disorders Association found that one in five women took laxatives to lose weight, with the figures far higher (11 per cent) among female students...

However, the risks of taking large numbers of laxatives are serious. Melissa Booth died of heart failure, aged just 17, as a result of her use of laxatives and diuretics....She died because of a lack of potassium in her system, which triggered a heart attack....

Click here for complete article (and single page version).

Medical privacy updates

The Institute for Health Freedom has just released the December issue of Health Freedom Watch. A few highlights:

The Boston Globe reported that Blue Cross Blue Shield of Massachusetts, the largest health insurer in the state, plans to collect detailed personal information on enrollees seeking mental health treatment. Plan members will answer 58 personal questions (on paper or through a secure website), including questions about their moods, feelings, and sex lives. [The questionnaire is online.] If enough patients don’t comply, their doctors or therapists could be denied annual increases in reimbursement.

Some psychiatrists and mental health-service organizations have already voiced concern over the policy. "Who in their right mind would fill out such a form?" said Dr. Marc Whaley , a Chatham psychiatrist and president of the Southeastern Massachusetts Psychiatric Society. "It's just an intrusive invasion of privacy."

Bruce Mermelstein , president of Comprehensive Outpatient Services, which serves 2,000 clients at mental health clinics in Newton, Chelmsford, Lowell, and Fitchburg, said patients should be concerned about privacy issues. "We generally don't feel positive about sharing any information with an outside source. That's a legitimate worry," he said....

The Wall Street Journal recently reported that corporate giants Intel, Wal-Mart, British Petroleum and other companies are planning to digitize their workers’ health records and store them in a multimillion-dollar database. The Institute for Health Freedom adds:

The promise of employee ownership will be no guarantee of privacy. Here is why: The privacy rule actually permits over 600,000 doctors, insurers, and others to share individuals’ electronic medical records—without consent—for purposes related to treatment, payment, or health-care operations, a very broad category. About that rule, Journal reporter Theo Francis recently wrote in “Taking Control: Setting the Records Straight”:

*“Over the past three years, millions of Americans visiting doctors’ offices, pharmacies and hospitals have been handed forms and brochures discussing privacy rules under the Health Insurance Portability and Accountability Act, or HIPAA. Many assume signing somehow protects their privacy. It doesn't.

* “In fact, the disclosure notice essentially details the many ways a doctor can use and disclose medical information—often without a patient’s consent or knowledge.

* “Health plans and medical providers also must track some kinds of disclosures, and give patients a list if asked, including disclosures for public-health purposes, but not routine uses for treatment, payment or health-care operations.”

Thus, even though big companies promise employees they will own their electronic medical records, workers won’t control access to them unless (1) the privacy rule is changed or (2) company contracts guarantee control....

Addendum: Major health insurers have already begun creating national databases of medical records, as Kaiser Daily Reports reported this past August:

The Blue Cross Blue Shield Association on Friday announced the creation of Blue Health Intelligence, a database of claims on 79 million enrollees that will provide "a treasure trove of information that employers working with health plans can use to extract greater value for their health care dollars."

Blue Health Intelligence will include all medical procedures and other care from 20 BCBS insurers in 34 states. Information identifying individual patients will be stripped. At first, local BCBS insurers will provide the information to employers and will offer quality reports to doctors and hospitals on the care they provide...

Employers will be able to use the data to analyze how their workers are using health care services, the Pioneer Press reports. BCBS officials said they also have received inquiries from pharmaceutical companies and medical device companies that would like to access the database.

Click here for complete article (and single page version).

Fat, healthy moms

This week, “skinny or underweight women” were being frightened by headlines that they’re at heightened risk of miscarriage. Except, the study being reported couldn’t reliably conclude that. A more accurate statement of the study’s findings also happens to be a much more positive and reassuring one:

Being fat does not increase risk for miscarriages

This is information millions of women need to know. Women wanting children have been threatened and terrorized about their fatness for years. Public health officials have been telling them that their “extra body weight” poses serious and life-threatening complications and that they are putting themselves and their unborn babies at risk. Among the popularly believed scares are that “obese women are far more prone to complications such as miscarriage.” Never reported, however, is that the quality evidence — or more precisely, the lack thereof — doesn’t support the greatly exaggerated scares.

Tomorrow, we’ll see an example and look at the study behind the most recent admonition that “women must lose their pregnancy weight because weighing even a few pounds more jeopardizes their second pregnancy.” It made all the news.

Today’s heartening study was published in the International Journal of Obstetrics and Gynaecology. Researchers at the London School of Hygiene & Tropical Medicine looked for associations between biological and lifestyle factors and the odds of miscarriage. The researchers took care to try and ensure they were looking at a sample of women representative of the general population. They gathered data collected on surveys from about 6,700 British women, which asked the women about their reproductive histories, considering each pregnancy in turn. They were also asked to complete a lifestyle survey and a food frequency recall questionnaire surrounding their most recent pregnancy. About 600 first trimester miscarriages were reported; but to increase the information on miscarriage risks, women whose latest pregnancy was not a miscarriage were given another questionnaire about their most recent miscarriage. The researchers applied statistical modeling of the data to look for correlations among factors they thought might be important (such as smoking and caffeine) and determine the odds ratios.

This type of study design is called “case-controlled” and is retrospective because it looks backwards through histories trying to explain an adverse outcome among a certain group. There are several caveats to these types of studies. Researchers look for things they think may be related to a health problem and could miss more important ones. The data relies on people’s memories and is subject to recall bias, where people are more apt to remember things they believe related to their illness. It’s the — “Oh, it must have been those burgers I ate” — guilt phenomenon. And, of course, they are looking for correlations, hoping to find ones that are statistically significant, but which can never prove cause.

They found three correlations that could be considered viable for these types of observational studies (relative risks two to three times higher than baseline): Higher maternal age (over 40 years) had 5 times the risk for miscarriage; stress, depression or traumatic events was associated with 3 times higher risks; and women who drank alcohol every day had 2 times the risk. The body of research supports a higher risk among older women, and some studies have suggested links between stress and pregnancy-related problems, including premature births and low birthweight babies. Researchers with the March of Dimes Birth Defects Foundation believe these are the most significant factors in the increases seen since 1981 in pregnancies not carried to term (9.4% to 11.9%) and today’s highest rates of preterm births ever in the U.S.

But when it comes to the lifestye and other dietary factors, the odds ratios found were not tenable — they were too small to be considered valid for these types of studies. In other words, none of them proved to be a concern. The numbers were so trivial they could be due to chance, statistical bias or errors in the computer model, or to things not even considered in the study design. Trying to make sense of these small untenable percentages is impossible because they aren't sensible. So using nonfindings to make any conclusions or recommendations is unsound. Remember, finding a solid correlation is the first step towards narrowing down a cause that will need confirmation with other types of studies; and if researchers can’t even find a credible correlation, then we can relax and move on.

Yet the political correctness in the reporting of this study’s findings were unmistakable. The media and researchers were quick to promote the idea that eating more fruits and vegetables and having a “healthy diet” and taking vitamins “may lower risks for miscarriage by 50%.” The study didn’t actually show a cause and effect at all, merely associations, so it’s an unsupportable leap to make such a suggestion. I’ll show you why in a minute.

Here are a few examples of how foods and behaviors are oftentimes more likely to be markers for something else. Their results found eating fruits and vegetables each day was associated with a 50% lower risk for miscarriage. (That is 50% of a 12% actual incidence.) It’s not that eating fruits and vegetables are bad, because good nutrition is important during pregnancy; but whether fruits and vegetables are the answers to reducing miscarriages or have any effect at all simply wasn’t shown in these weak correlations, nor has it been shown in the available research to date. Some may scoff at this concern thinking it’s not harmful to believe it anyway, but it is important because increasingly people suffering from health problems are being wrongly blamed for “bad” behavior or eating “incorrectly,” and made to feel guilty that a health problem is their own fault. More likely, if this correlation is ever able to be replicated, it’s indicative of women of better social class, economic means and with better access to health care.

In fact, those 50% lower risks were identical to those of women in the study who said they had planned for their pregnancies — meaning the women were less likely to be poor, young, unwed mothers and more likely to have stable homes and economic situations, and better prenatal care.

And even more interesting, those risks were identical to those of women who had flown in the past 3 months — with those flying the greatest number of hours having even greater reductions in risk (60% lower). Clearly, this is measuring either business travel from higher-level employment or vacation travel from greater disposable income. In other words, all of these lifestyle factors are more likely markers for wealth and advantage.

“Women, rack up those frequent flyer miles to lower your risk for miscarriage!”

Saying that sounds illogical, but it reflects just how faulty it is to apply these types of associations.

In addition to promoting fruits and vegetables, we heard that eating daily chocolate reduced risks. If that is ever replicated in clinical studies, it might actually prove to not be the chocolate at all, but perhaps a marker for women who are more relaxed, happily enjoying their foods, eating well and not dieting. Looking at the study, chocolate was associated with a mere statistical 15% reduced risk. On the other hand, eating white meat was associated with an 18% lower risk. And red meat, eggs, 1 or less drinks a week, and caffeine had no effect.

But the value of this study can probably be most appreciated for what it didn’t show to be a concern, besides all of those negligible dietary factors. Negative findings - when they can't even find a correlation - are every bit as important as positive ones. And anything that can lessen needless concerns and stress for expectant mothers might also prove to help ensure even better outcomes.

Being fat did not affect the risks for miscarriage at all, despite beliefs that it does. In fact, the “obese” women had even slightly lower risks than the “overweight” women. And that is news women can use.

Click here for complete article (and single page version).

One the media ignored: Please don’t weigh the children

The panic surrounding childhood obesity has led public schools administrators, politicians and consumer groups to get behind “prevention” approaches which encourage weighing and screening children for “obesity.”

Without regard to the evidence.

Project EAT, a study of 2516 Minnesota adolescents, led by Dianne Neumark-Sztainer, PhD, MPH, RD at the University of Minnesota just released more findings suggesting harm from current “obesity prevention” strategies. They found that programs focusing on children’s weights encouraged self-monitoring, especially among the girls.

But weighing themselves had no effect on their BMIs (body mass index) for the older teens (15-20 years old) over the five year period. However, among younger teen girls (13-17 years old) weighing themselves often, their BMIs increased nearly two times over their classmates not weighing themselves during those years.

Among all of the teen girls, weighing themselves also predicted unhealthy weight control behaviors and disordered eating within just a few years. Girls are more concerned with weight loss than the boys, and for them, weighing may be harmful, according to the researchers. The combination of being a restrained eater and receiving negative feedback when they step on the scale has been shown in studies to have a strong negative impact on their well being.

The authors note that unlike some studies reporting on successful “weight maintainers” and claiming that weight monitoring helps, this study group was more representative of the general population. Their findings also suggest that approaches for adults are not appropriate for young people because of their developmental differences.

Based on the findings throughout this Project, the researchers advise that public health interventions should avoid messages focused on weight.

Sadly, this is not the first such study to suggest harm. It concurs with the body of evidence showing the unsupportable nature of all "childhood obesity" initiatives. The U.S. Preventive Services Task Force, under the Health and Human Services Department, conducted a comprehensive review of all of the evidence on screening and preventive interventions for “overweight” children and adolescents last year. They found the evidence did not support routine screening, behavioral counseling or preventive interventions. Such measures had not been shown to improve health measures or health outcomes for children and adolescents. Their recommendations did caution that the potential harm of screening and weighing young people included: “labeling, induced self-managed dieting with its negative sequelae, poorer self-concept, poorer health habits, disordered eating or negative impacts from parental concerns.”

Musings:Beliefs, not evidence, continue to come first. Don't our children deserve better?

Click here for complete article (and single page version).

Pour salt on it

A recent Australian article headline caught attention with its “Deadly sprinkles in lunches” and claims that a favorite “cheese stick could be killing your children.”

We were told that we are feeding our children things that are going to cause heart attacks and strokes later in life and that the salty foods parents are allowing their children to eat are like feeding them “solid seawater for lunch.” Without a doubt, fear was being used to market something.

The person quoted in the article was Professor Graham MacGregor of St. George’s University of London. In 1996, he established CASH (Consensus Action on Salt and Health) “to reduce salt consumption and increase public awareness of salt and its effects on health.” This year he took efforts global.

The evidence for these headlining claims was a recent study he co-authored with Feng J. He and published in the journal Hypertension. The media echoed the CASH press release, saying this study proves that a modest reduction in salt intake among children can almost immediately cause significant falls in blood pressure, “which in turn could lead to major reductions in the risk of developing stroke, heart attacks and heart failure later in life.”

This study is also the evidence used by the Center for Science in the Public Interest to supports its recent call on the FDA to revoke salt’s status as “generally recognized as safe” and regulate it as a food additive. Michael Jacobson, executive director of CSPI, stated in Salt the Forgotten Killer (2005): “Reducing sodium consumption by half would save an estimated 150,000 lives per year.”

Such extraordinary claims require extraordinary evidence. Does this study hold up?

This study is said to be the “first ever meta-analysis of salt reduction studies in children.” And it epitomizes every caveat of these types of studies. MacGregor and He “developed a strategy” of their own design to look for words in several databases and through reference lists at the end of articles to find studies of salt reduction in children. They only used studies published in English and of the 33 they found, decided to use 10 on children for this report. The studies all had different designs, with only one being a double-blind trail and only 9 were randomized; the studies varied in length from 2 weeks to 3 years; compliance with salt reductions appeared poor in two of the studies; we have no information on the racial/ethnic mix of the children and if it is representative of the general population; and only 3 measured 24-hour urinary sodium levels — which the researchers admitted is “the only accurate way to assess dietary salt intake.” Simplifying what they did next, they pooled the data on blood pressures and net changes in salt intake, and used statistics to estimate the changes as needed to fill in missing data. Then, they applied two computer models to plot the results and more statistical analyses to reach their findings.

What they reported was that cutting salt intake by 42% reduced systolic blood pressures in the children by 1.17 mmHg. Most parents and children would consider such a salt reduction — nearly in half — to be extreme; while most doctors would debate the clinical significance of a mere 1 point reduction in blood pressure. Taking blood pressures in young children is an imprecise task at best and the children in these different studies were also at varying stages of development, with corresponding variable changes in blood pressures over the study durations, according to their growth and size.

The researchers stated that the “physiological need for salt intake in children has not been studied,” but concluded anyway that “current salt intake in children is unnecessarily high and is very likely to predispose children to develop hypertension later.”

They went on to declare that these results “provide strong support for a reduction in salt intake for children. [And] if continued, may well lessen the subsequent rise in BP with age and prevent the development of hypertension. This would result in major reductions in cardiovascular disease.”

Their press release promised possible “massive population health gains.”

·But this study did not examine a single child.

·It conducted no clinical research to learn how much salt is needed or might be harmful for children.

·It offered no clinical evidence to know if a lower blood pressure reading of 1 point means anything for children’s health or is maintained as a child grows.

·It offered no proof that a blood pressure reading during childhood has any bearing on adult blood pressures or heart disease.

·And worse, it didn’t follow a single child to see if there were any health effects from the salt restrictions they are recommending.

In other words, this study offered no clinically meaningful evidence, only speculations. While controversy, debates and politics have surrounded salt recommendations for decades, as Gary Taubes outlined in the magazine Science, the body of evidence has not demonstrated that low-salt diets result in health benefits for the general population, nor that current salt intakes of Americans pose health risks for the general population. Even a recent Cochrane Library review of the evidence found insufficient information to know what effect salt reduction might have on health and mortality.

Of greatest concern is evidence suggesting that low-salt diets may actually be harmful for most people; increasing heart attacks, mortality and insulin resistance (a precursor to diabetes).

Shouldn’t we have something tenable to go on before experimenting on an entire generation of children? I suspect most parents would think so.

© Szwarc 2006

Click here for complete article (and single page version).

Meta-Who?

Last week’s report on the meta-analyses done by researchers at the Wolfson Institute of Preventive Medicine in London, led many to ask ‘Just what is a meta-analysis’?

Since there’s another example coming right up, let’s take a moment to understand these new types of studies. You might not come to think of these studies as studies at all, but many believe they are.

Meta-analysis is a statistical method first proposed in 1976 by an educational psychology statistician, Gene V. Glass, as a way to analyze findings from a bunch of individual studies.

A meta-analysis is an analysis of other analyses to create a new study.

This technique is frequently used when there are no large, high quality, randomized, double-blind, placebo-controlled clinical trials — the gold standard — to prove the validity of a treatment or theory. So a meta-analysis lumps together whatever evidence is available: the good, bad and indifferent. Some studies may show a weak positive statistical association, others report none, and others may even report a negative correlation. It can end up giving the same weight to well-designed studies as poor ones, and create mud. By pooling what are oftentimes weak studies together, it is hoped to create a statistically stronger estimation of an effect. And therein lies the rub.

A favorite definition among critics is that of professor John Brignell, PhD, who authored The Epidemiologists: Have they got scares for you!--

Meta Analysis is making a strong chain by combining weak links.

When you’re reading about a study and see the word, “meta-analysis,” it’s a warning sign to proceed with extreme caution. There are several caveats to this technique. First,

it depends upon what studies the authors choose to include. Oftentimes, only published studies are used and those suffer from “publication bias.” This is the well-known phenomenon where studies showing positive results are much more likely to be published than “boring” ones showing no effect. Most studies disproving things never get published. Some studies are also updated and re-released multiple times, ‘stacking the deck.” A systematic review of the problems with meta-analyses by H.J. Eysenck in the British Medical Journal found meta-analyses often contradicted each other mainly because of the arbitrary nature of deciding which studies to include and that “these criteria had often been applied so as to favour a favorite hypothesis or vested ideological interest.”

Second, the studies lumped together in a meta-analysis can vary considerably in quality, measures, populations, methodologies and statistical analyses. Sort of like apples and oranges.

As John Bailar, III wrote a recent discussion of the discrepancies between meta-analyses and later large, randomized, controlled trials in the New England Journal of Medicine: Meta-analysis “does not work nearly as well as we might want it to work. The problems are so deep and so numerous that the results are simply not reliable.”

This is not to say that everyone believes all meta-analyses are worthless, but at least two-thirds are of such exceedingly poor quality they cannot even be used to guide clinical practice, according to an evaluation of 139 such studies, recently published in the journal Critical care. They cautioned doctors to think carefully before even considering applying the results of meta-analyses in their practices.

Click here for complete article (and single page version).

Living on rice cakes, fruit and water

Once upon a time, Twiggy was an oddity. Today, the figures fashionable in our culture are even thinner, with most Hollywood stars weighing far below what defines starvation. Few children, young people and adults, however, realize these thin bodies are unnaturally thin and achieved through extremely unhealthy means.

The Sun talked with model Tarryn Meaker this past week to learn what really happens behind-the-scenes of fashion. Meaker is now a healthy size 16 and “loves her body.” She revealed: “The fashion trade is riddled with drug addiction, manipulative agencies and eating disorders:”

“I don’t know how much I weighed at my lowest, but when I look at the pictures now I was really skinny. I look ill. At the time I was looking in the mirrors and seeing fat. As well as not eating I was taking handfuls of diet pills — most have been banned now because they are so dangerous. Every time I ate too much, I would take more pills. Of course my health suffered...”

“There was a procession of people telling me, ‘You’re fat,’ ‘Your skin’s bad’ or ‘You’re ugly.’ As a teenager just learning about myself and my body, it was crushing...”

“I have lived and worked with fashion models all over the world, and it’s a mess. I saw models on strange diets, drugs, coffee and cigarettes . . . all the clichés are clichés because they are true. The turning point for me was reading all about myself in a college book. I was studying psychology and when I read a description of a textbook bulimic I realised I was reading about me.”

“It wasn’t as easy as turning a switch off because controlling what I ate had become such a part of my life. But I re-prioritised and now I am just enjoying the job without obsessing about what I look like. I’m still working and am so much happier now — and there’s no price you can put on that.”

Click here for complete article (and single page version).

Another lovely example of body acceptance and food sanity

It’s rare to encounter people in the food business anymore who are unapologetic about loving to eat and who are comfortable with food and their bodies. Most intersperse every other sentence with tiresome little twitters about a food being sinful or fattening, and admonitions to only allow yourself a few bites. Or worse, they are absorbed with low-fat, “healthy” dishes as if eating is only about supplying the proper milligrams of vitamins and protein and one dare not enjoy it.

As The Sun reported on Saturday, Nigella Lawson loves to eat and “is a breath of fresh air when talking about her figure.”

"I’ve never met a doughnut I didn’t like, [my favourite] is sugar on the outside, jam in the middle.We’re all worrying endlessly, it’s relaxing to think I don’t have to fight the fight any more, life is so much rosier."

A new three-part series on BBC2 - called Nigella’s Christmas Kitchen - will explore the pleasures of festive eating. She said: “There’s nothing I hate more than people who think they’re too chic for Christmas. You’ve got to have turkey, the best ingredients for stuffing are bacon, onions, apples, eggs... and ginger cake.”

She is happy with her full figure. In an earlier article she said she vowed never again to go on a diet after her mother’s admission shortly before dying of cancer.

My mother was tortured by her weight. When she was dying she said: ‘It’s the first time I haven’t worried about what I’m eating.’ You’ve got to think how warped it is to feel released from dieting because you have a terminal illness.

When I had a daughter, I vowed I would never say ‘I hate myself, I’m fat’ in front of her because I didn’t want to pass it on.

You can’t live on 1,000 calories a day and be happy. Now diets are all saying ‘This isn’t a diet, this is a way of life, forever.’ Well, that makes me want to throw myself out of the window.

Now I don't know what I weigh. I don’t want to be totally consumed by that world.

Click here for complete article (and single page version).

Should we care what works and what doesn’t?

Weight loss diets, convictions about “good” foods and fears of “bad”foods, and alternative medicines all share surprising similarities.

To some, this may sound like an outlandish notion. But seasoned dieters and health food advocates will be familiar with many of professor Waxman’s comments in his British Journal of Medicine article, “Shark Cartilage in the Water”:

...It is estimated that up to 80% of all patients with cancer take a complementary treatment or follow a dietary programme to help treat their cancer, writes Jonathan Waxman, Professor of Oncology at Imperial College London. Yet the rationale for the use of many of these approaches is obtuse – one might even be tempted to write misleading...

So why do patients take alternative medicines? Why is science disregarded? How can it be that treatments that don't work are regarded as life saving? Waxman believes that it is because the complementary therapists offer something that doctors cannot offer – hope. If you eat this, take that, avoid this, and really believe this then we can promise you sincerely that you will be cured.

And if the patient is not cured, it is the patient who has failed, not the alternative therapy. The patient has let down the alternative practitioner and disappointed his family who have encouraged his "treatment." As well as the complementary medicines they take, many patients will have changed their diets in order to cure their cancers, says the author....Why do patients change their diet? For some it is a way of taking back some control of a situation that is entirely out of their control, says Waxman. For others it is because of the pressure put on them by families, friends or vested interest groups to "go organic."...

Feel-good beliefs are also big business, he said. What many of these emotionally-charged diet and alternative ploys have in common is that they appeal through beliefs, faith and hope, and take advantage of the placebo effect. This effect describes how we all can be made to believe water or a sugar pill, an energy modality, a supplement or “healthy” food really helps us. Our minds can make our bodies manifest an extraordinary array of physical symptoms and make us believe we are experiencing better health, improvement from our ills (or worsening health), when nothing has actually changed. The power of placebos was described by Dr. Steven Barrett, MD, vice president of the National Council Against Health Fraud.

If we had to choose one thing to learn that could most protect ourselves from being taken in or harmed by fraudulent products, practices or worries, this would be it: the power of placebos...Yet it is one of the hardest things to understand.

It is so unbelievable, that no one realizes it is happening to them ... when it is. As incredibly as it may seem, we cannot rely on anecdotal evidence or experiences, even when they’re our own! When we expect to feel better, we very often think we do.

It is so profound that doctors and patients can be fooled. The placebo effect is so intense, clinical experiments are necessary to know if a health or dietary intervention is really effective or if it was the placebo effect.

In a recent placebo controlled clinical trial, people undergoing fake knee surgeries had just as good of results as those getting real arthroscopic knee surgeries, and the patients were so pleased they recommended the treatment to their friends! Imagine the surgeons’ surprise to learn that a treatment even they believed in was a sham!

This illustrates an important way that mainstream medicine and alternative modalities traditionally differ. When an alternative modality is shown to work, it is no longer “alternative” and becomes part of mainstream medicine. But when a treatment is shown to not work, medicine ideally looks for something that does, alternatives never do. Clearly, there are a lot of treatments the medical community has come to believe work. And, like alternative practitioners, they can be just as resistant to those who question them or want them tested, as Dr. Judith S. Hochman, director of the cardiovascular clinical research center at New York University medical school, found when she dared to test the belief in angioplasty that cardiologists have long held. But mainstream medicine generally embraces science and tests theories. And, in time (which can seem awfully slow, as in the case of “obesity”-related science), the medical community responds to clinical evidence and treatments change. “This is why we have clinical trials,” said Dr. Hochman. Trial results often surprise even doctors. Dr. Hochman and her colleagues expected to find that angioplasty would reduce heart failure, subsequent heart attacks and death, but it didn’t. With this knowledge, medical practice should change, she said, affecting some 50,000 patients a year in our country.

So when we are confronted with steadfast claims about the effectiveness of alternatives, the benefits of certain foods or diets, or any treatment, it can be beneficial to look closely at the evidence.

Oftentimes, the weakest evidence relies on subjective feelings, such as fatigue or energy level. Those are typically the placebo effect and suggestible. Simply doing something we believe in can also make us unconsciously change our habits, such as get more rest or activity, leading us to falsely attribute the changes in us to the placebo. Even participating in a study can also make us unconsciously change our habits, which is why control groups are necessary in clinical trials. The power of suggestion in affecting how we think we feel has been demonstrated in many investigations.

“In many disorders, one third or more of patients will get relief from a placebo,” said Dr. Barrett. “Temporary relief has been demonstrated, for example, in arthritis, hay fever, headache, cough, high blood pressure, premenstrual tension, peptic ulcer and even cancer. A large percentage of symptoms either have a psychologic component or do not arise from organic disease.” Perceptions, however, don’t mean that the actual disease process has been altered and relying on a placebo to cure real diseases, such as cancer, can be deadly.

Of concern to medical professionals is not only that patients may delay seeking medical care that has been proven to help or could cure them, but that nonscientific practitioners using placebo therapies often are those leading patients to believe other imagined dangers and illnesses, discouraging them from seeking healthcare and preventive care (such as immunizations), and selling dangerous quack therapies.

Pain is especially subjective. What we feel physically is partly emotion and anxiety, the body’s reaction to tension. So very often, things that help us feel less anxious, redirect our attention, or give us a sense of control can lessen the distress part of the pain and make us reinterpret our symptoms. Someone taking the time to talk to us can be all it takes sometimes to make us feel better. While this is used to support many healing modalities that work by placebo, many doctors believe that their relationship with their patients should be based on honesty, trust and respect. As patients, many of us would probably agree, and feel deceived to learn we had been sold a placebo.

Health professionals also note that placebos are not necessarily a cost effective use of oftentimes limited healthcare resources. In a clinical study of 321 people with low back pain, for example, chiropractic manipulations were helpful, but no moreso than giving patients an educational booklet on low back pain, at one-third the price. A recent review of 100 scientific studies found no credible evidence to support claims that organic food is more nutritious or better tasting — a point even echoed by the Organic Trade Association. Yet, while biologically no different and offering the same nutrition to our bodies as conventionally-produced foods, “healthy” all-natural foods can cost many times more.

What most often outwits even the most skeptical of us, however, is forgetting that most of our ailments are self-limiting and improve over time regardless of what we do. Or they have natural waxing and waning of symptoms — which can coincide with something we did, leading us to attribute our action to the change in how we feel. It is like suffering from a cold for 6 days, taking a special vitamin and feeling better the next day! We would have improved just as quickly had we done nothing, but it is easy to believe it must have been that vitamin. We can even believe our child or animal appears more comfortable, when their illness may have simply run its natural course or they’re calmer simply because we are!

Nocebo is the opposite effect: illness and unpleasant effects caused by the suggestion or belief that something is harmful. Nocebos are commonly used to scare us about “bad” foods and “obesity.” We are surrounded by real-life attempts at “aversion therapy!” But there is no credible evidence that any food is actually harmful (excluding, of course, rotted, germ-ridden foods and people with severe allergies or rare metabolic disorders) or that people die from being fat.

Trying to scare people that they’ll develop cancer or another horrible chronic disease, get fat, or die prematurely if they eat “bad” foods or are exposed to contaminants has become a familiar marketing tactic over recent years and the nocebo effect is at work in many. Yet, using fear is not benign and the nocebo effect can have very real harmful effects on our bodies. It is well known among scientists that beliefs and fears can create mass psychosomatic illness and shared delusions. There are growing examples of the nocebo in the scientific literature.

People who are told that they have high blood pressure (when they don’t) begin to feel sick and call in sick much more often. In double blind clinical trials, when healthy people are given a placebo drug and told of possible side effects, about 20% develop dizziness, nausea, vomiting and even depression. In another study, when patients breathed in a vapor they were told contains a chemical or allergen about half developed breathing problems, including some with full-blown asthma attacks. When given what they believed was a bronchodilator, they recovered promptly. In actuality, both the “irritant” and the “medicine” were nothing more than salt water.

Food and health scares have never been more rampant, and so are the fears. People who believe sugars, fats, refined white ingredients, processed foods, meat products or chemicals in their food are bad actually think they get sick when they eat them. Sadly, the belief behind forbidden foods is so strong that when they eat something they believe bad or wrong to eat, they have extreme symptoms, including headaches, chest pain, nausea, rashes and weakness.

We are not what we eat, we are what we believe.

Our memories are shaped by who we are and what we have been led to believe. We seem to reinvent our memories, and in doing so, we become the person of our own imagination. — Elizabeth Loftus, Make-believe memories, 2003.

© Szwarc 2006

Click here for complete article (and single page version).