Weight loss surgery results in FDA warning

A bariatric surgeon who invented a type of bariatric surgery was issued a federal warning today for implanting 175 patients with an experimental, unapproved medical device without obtaining full informed consent.

Newsday also reports:

Dr. Mathias A.L. Fobi also implanted 185 patients with an experimental device before receiving approval to do so from either the Food and Drug Administration or the institutional review board overseeing the study, amid other violations of federal regulations, according to the Jan. 24 letter....Fobi, of the Center for Surgical Treatment of Obesity in Hawaiian Gardens, Calif., invented the Fobi pouch. This type of gastric bypass surgically reduces the size of the stomach to a one- or two-tablespoon pocket, vastly restricting the amount patients can eat.

The FDA warning can be read here.

It is important for anyone considering any of these surgical procedures to understand that dozens of types and variations of bariatric procedures are being regularly developed and performed by surgeons around the world, yet all remain unproven. In the more than forty years that bariatric surgeries have been performed, no randomized, controlled clinical trials have yet shown any long-term improvements to actual health or that lives are saved or extended by any of these surgeries, and especially not for the newer variations coming out. As obesity researcher, Dr. Ernsberger, Ph.D., of Case Western Reserve School of Medicine, Cleveland, Ohio, noted in an overview or risks and benefits of bariatric surgeries, only three animal tests had been reported before the procedures were begun in humans—highly unusual as most surgical operations are first perfected with extensive animal testing, he said.

Doctors discussed the ethical concerns of bariatric surgeries in the April 2003 issue of the Journal of the American Medical Association. “This is the classic problem in surgery-innovation without the research to guide it,” said Laurence B. McCullough, Ph.D., a professor of medicine and medical ethics at Baylor College of Medicine in Houston, Texas. “So all this should be brought under experimental protocols...That’s how you handle the conflict of interest. Make sure you tell the patient: ‘The procedure is investigational; we don’t know if it will help you.’”

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Anatomy of an epidemic

When you hear claims of an epidemic — of obesity, type 2 diabetes or whatever — have you ever stopped to critically question if they’re really true?

The news is filled with alarming statistics, nonstop images of the most extreme examples, and rhetoric that becomes more frantic with each passing day. How many epidemics are we told are now reaching “pandemic proportions” and that we must save the children?

Hearing the word “epidemic,” let alone “pandemic,” leads us to instantly think of danger and crisis. It’s easy to believe the claims, repeat them or, worse, act on them without knowing if the information is even correct. It never occurs to most of us to even consider that an epidemic can be created and not be due to anything ominous at all.

What if you learned that most scientists don’t see an epidemic of obesity or type 2 diabetes, but that the evidence shows very modest increases in actual numbers and that what really is at work is an epidemic of diagnosis, with a hefty dose of marketing spin?

A study released in the journal of the American Psychological Society in 2005 provides an invaluable insight into how an epidemic is created and how public perceptions can become completely disconnected from the scientific evidence. The parallels between the epidemic they chose to examine for their study and the epidemics of obesity, diabetes and others are remarkable and can help us begin to think critically and see past epidemic hype. So, as you read this study, keep other popularized epidemics in mind. Later, we’ll come back and begin to put the pieces together.

Researchers at the University of Wisconsin-Madison and the University of Montreal-Quebec, Canada examined the scientific evidence behind an epidemic of autism that mainstream media was calling mysterious and frightening and that new cases were “exploding in number.” What they found was that more people were fitting into the current criteria for autism — not because there was more autism but because:

· the diagnostic criteria had been purposely broadened

· public awareness had been deliberately increased through effective marketing, and

· greater lengths were being intentionally taken to identify cases

“The phenomenon of autism has existed most likely since the origins of human society,” they wrote. Autism didn’t exist as a diagnosis, however, until the 1940s when a constellation of differences that had always existed in the population came to be named “autism.” But it wasn’t until 1980 that autism was first added to the Diagnostic and Statistical Manual of Mental Disorders (DSM-III) using six mandatory criteria. Most of the cases in this first tightly-defined criteria had severe associated problems. But over the years those criteria underwent several changes, each one widening the definition to include more subthreshold symptoms and milder variations. The most recent DSM-IV has 16 criteria, only half of which need to be met to be diagnosed autistic. The evidence shows that it’s these mild variants that now account for most of the currently diagnosed cases, they found. They added:

Consider also the recent practice of codiagnosing autism alongside known medical and genetic conditions (e.g., Down syndrome, Tourette’s syndrome, and cerebral palsy); the contemporary recognition that autism can exist among people at every level of measured intelligence, the deliberate efforts to identify autism in younger and younger children, and the speculation that many individuals who would meet present-day criteria were previously mis- or undiagnosed, including some of the most accomplished, albeit idiosyncratic, historical figures such as Isaac Newton, Lewis Carroll, W.B. Yeats, Thomas Jefferson, and Bill Gates.

Most crucial to understand, they cautioned, is that “broadening the criterion will result in a dramatic increase in diagnosed cases.” They illustrated how simply lowering the cutoff for the definition of “tall” from 6’-2” to 6’ a decade later would create a 27.3% surge in the cases of tall males — without any real increase in height among a population of men. Similarly, they found that the broader definition for autism alone could explain the 27.3% increase in California children receiving labels of autism from 1987 to 1998. When the earlier criteria was applied for all the years, there was no clinically significant difference.

A surge in perceived cases, coupled with growing media attention to the mysterious increases, led to legislation being introduced, research being funded, and school and medical resources being mobilized to identify and report more cases so as to ensure that children were made eligible for new special programs. “Child count” screenings and reporting were made mandatory and the data further “used as supportive evidence of an autism epidemic.” They exampled a message that was distributed in October 2003 by the Autism Society of America, saying: ‘‘Figures from the most recent U.S. Department of Education’s 2002 Report to Congress on IDEA [Individuals With Disabilities Education Act] reveal that the number of students with autism [ages 6 to 21] in America’s schools jumped an alarming 1,354% in the eight-year period from the school year 1991-92 to 2000-01.’’ [emphasis added]

What the Autism Society failed to reveal, they said, was that the Report to Congress had included this note: “Prior to the 1991–1992 school year, there was no child count of students with autism; autism did not even exist as an IDEA reporting category. Moreover, in 1991–1992, use of the autism reporting category was optional (it was required only in subsequent years).”

A very common and easy mistake to make is to think “diagnosis” means actual disease. As was discussed in an earlier post, more screening leads to more diagnosis — that is not the same thing as more disease. It’s the ‘seek and ye shall find’ principle. Such an epidemic is “an epidemic of diagnoses.”

But there are larger reasons for the popularity of epidemics. Cries of “epidemic” bring in more money — for research; for foods, products and programs to identify and address the epidemic; and for “health” initiatives to prevent the epidemic. Cries of “epidemic” bring more stature to one’s research; academic and government promotions; votes for political office and support for one’s programs; invitations to speak and sit on important committees; book sales; and more notice and prominence to one’s agency, program, institute, publication or foundation.

“Epidemics solicit causes; false epidemics solicit false causes,” said the researchers.

If there is no real epidemic, then there is also nothing to blame — no child or parent, person, food, lifestyle, big corporation or environmental evil. Speaking out against an epidemic is a very unpopular thing to do as it goes against a lot of vested interests dependent on that epidemic, as these authors discovered, and few are willing to do so.

The researchers ask readers to consider the harm resulting from cries of an epidemic. What message is being sent to children and adults when their increasing numbers are called an epidemic, a pandemic, a scourge? It’s not advocacy, helpful or healthful. True scientific inquiry, medical advances, and our compassion need not be lessened by following scientific reasoning and acknowledging there is no epidemic.

Lead author, Dr. Morton Ann Gernsbacher at the University of Wisconsin has made their paper, “Three Reasons Not to Believe in an Autism Epidemic,” available free at her website, here. She and Dr. Hill Goldsmith are parents of an autistic child and the third research associate, Michelle Dawson at the University of Montreal, is autistic.

© 2007 Sandy Szwarc

Addendum: Their article is merely used as an illustration of an excellent portrayal of the creation of an epidemic, but autism is not the focus of this blog. For discussions on autism, please refer to bloggers devoted to this issue, such as Autism Diva and Autism Street.

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

Home bakers rise up

Crisco has just announced its shortening is going to a new formula with zero grams of transfats per serving. The new formula “uses less partially hydrogenated cottonseed and soybean oils and more fully hydrogenated cottonseed oil — which contains no transfat.”

Some home bakers reacted to the news just as Wendy Mitchell did in this humorous piece in the Ledger Independent of Maysville, KY:

Leave my Crisco alone

The food Nazis have gone too far. They are messing with an American icon, apple pie. What is pie without a firm, flaky crust? There are too few pleasures in life and my pie crust, with REAL Crisco is one of them. You need Crisco for that.

Now the company that makes Crisco has caved to the food Nazis and is changing the recipe. Leave my Crisco alone. Thanks to some transfat Mafia I will have to go shopping for Crisco tonight. A lot of it.

How long does Crisco last? I will be finding out. I have also been trying to calculate how much Crisco I will need to make it through the rest of my life without having to purchase the trans fatless concoction the company claims tastes and cooks the same.

Say five pounds a year, plus an extra can for holidays and special events, like the time I made 65 pies for a benefit sale in one day. That took five pounds all by itself....

How do you take something like transfat out ... by adding something else. How do I know that the something else won't be bad for me...

Crisco lovers unite! Put your cans on the line. Demand equal product access with the trans fatless and cookie on!

Others who grew up on shortening likely had similar reactions.

Spry, Crisco and other shortenings have been staples in American kitchens since the turn of the last century. The old cookbooks of our mothers, grandmothers and great grandmothers hold some of America’s still-favorite family recipes, made with shortening. All-vegetable shortenings were welcomed by home cooks for their purity and clean taste when they were first introduced in 1911. They were considerably safer than the often contaminated and adulterated lards and fats sold before their introduction. For many home bakers, shortening is the secret to achieving flaky pie crusts, delicate cookies and light cakes. That’s because the these fats inhibit long strands of gluten from forming in wheat doughs — hence, their name “shortening.” Shortening has enabled many women over the past century to win coveted blue ribbons at state and county fairs.

Partially hydrogenated oils, as in shortening, have other benefits for home cooks and commercial cooks, alike.

They help to keep cookies softer and lighter. [Make a batch of cookies with butter and one with shortening and see how much higher and lighter the shortening cookies are.]

Shortening has a higher smoke point (the temperature that an oil or fat breaks down, smokes or burns, and gives food an awful taste) than butter, margarine and many other oils, making it safer for frying and more ideal for achieving crisp French fries and donuts that have a delicate crust without being greasy inside. Deep fat fryers were standard kitchen items in many homes during the middle of the last century. Our Mother made donuts nearly every weekend and even more often made potato fries to go with her burgers, sloppy joes or fried chicken. Because these foods are eaten away from home moreso today and not made by Mom, many people fear they are somehow less good-for-us. But there is no credible evidence for such fears. (Although some Moms may have been better cooks than the kids in the red uniforms.)

Partially hydrogenating vegetable oils also makes them more stable and go rancid less quickly, meaning they can be safely stored for much longer periods than other oils. They came to be pantry stables, especially during war times and the Great Depression.

A lot of people today are being led to believe that transfatty acids are some new chemical being snuck into processed foods by evil food corporations and that they are totally unnecessary. This conspiracy thinking fails to understand history and the science of fatty acids. As Dr. David Klurfeld said in Nutrition News Focus: “Transfats are not there because the manufacturers don’t care about your health. If you want a cracker that does not go rancid during the summer or leaves a greasy stain on the pantry shelf, you cannot make it with a highly unsaturated fat like soybean oil. You either use lard or hydrogenated vegetable oils.”

Is there any evidence that whatever is going to be substituted for partially hydrogenated oils is any better for us? Of course not. This was never really a health issue. The dreaded transfats in our foods are a tiny fraction of the calories and fats in our diet. There is no need for most of us to fear that a minuscule amount of some nutrient in our food might harm us (or conversely, believe it has curative properties). “The dose makes the poison,” as the scientific adage goes. Thank goodness for that, too, or the human race wouldn’t have survived millennia, oftentimes eating stuff that would curl the toes of many today.

But consumers might find it reassuring to learn that since 1910, our consumption of total fats in cooking and baking has remained constant, averaging about 22 pounds per person per year (peaking at 23.5 pounds in 1950), according to the U.S. Department of Agriculture. Meanwhile, as recently explained, we’re healthier and living longer than ever.

Yet this panic over transfats has led many to believe there is something especially dangerous about partially hydrogenated fats. Yes, transfats are not all “manufactured.” They also occur naturally in many other healthful foods such as meat and dairy products. The U.S. Department of Agriculture estimates that 25 percent of transfats in a typical diet come from natural sources like beef, milk or lamb. In fact, trying to needlessly eliminate transfats from our diet could actually create health problems and lead to shortages in many important food nutrients found in baked goods, meats and dairy foods, according to the FDA.

Ms Mitchell may be right to be concerned that eliminating transfats from shortening could make a taste difference. When Mister Bee, the only producer of potato chips in West Virginia, went to a “healthier” cottonseed oil to fry its potato chips last summer, customers noticed immediately and the company received 15 angry customer calls a day and their sales dropped 6%. Customers said the new chip was darker in color, greasier and left an aftertaste. Mister Bee President Alan Klein admitted to the San Francisco Chronicle that there was a 'noticeable difference' in the new chip’s taste after being in the package for a couple of days. The company listened to customers and went back to the old oil.

P.S. Crisco says an unopened can of shortening can be kept at room temperature for 2 years. But things keep longer when cooler, so maybe devoting a deep freezer to your Crisco stash is the answer. But, I’m afraid it’s too late for Girl Scout cookies. :)

© 2007 Sandy Szwarc

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

“But Mommy, they made me do it!”

When we hear an idea that disagrees with something we’ve come to believe, our first instinct is to dismiss it and the science supporting it. To let ourselves critically question and think about something that goes against everything we’ve come to feel comfortable believing, is hard and unnerving.

The most careful, evidence-based science on dietary and body fat, transfats and cholesterol can be especially hard to embrace. The misinformation has been repeated so often, it has become the most believable. Recognizing the most supportable evidence is made even harder when trusted health authorities let us down.

The food fear of the day is transfats. It has become impossible to discuss it calmly and intelligently anymore because so many can’t get past the “transfats are evil, toxic and deadly” belief. It’s not surprising this misconception has become so widespread, we hear it everywhere.

David Katz, a professor of public health at the Yale University School of Medicine in New Haven, CT, was in the news equating transfats to “mercury and lead, slow poisons that consumers would be shocked to find in their food” and telling consumers “it’s a poison...This is really bad stuff. It’s got to go.”

Transfats have been equated to lead paint by Thomas R. Frieden, New York City’s health commissioner. He was quoted in the New York Times saying: “Like lead paint, artificial transfat in food is invisible and dangerous.”

And the panic has spreads on the internet with one worried poster saying of a Harvard study: “It found that increasing transfatty acid intake by 2% of total calories doubled the risk of MI! That’s equivalent to a 9-11 every year, just from one teaspoonful a day of trans fats per person!”

It would be funny if it wasn’t so sad that people have really become that afraid.

As a recent post discussed, the evidence for transfats endangering our health and leading to heart disease, cancer or other health problems is weak. How many remember thirty years ago when we were being led to believe that transfats and all-vegetable margarines were better for us, and animal fats and tropical oils were the bad fats? No wonder consumers are confused — they’re stuck in the middle of a ping-pong ball game that isn’t about their health at all. But a look at the science presented back then to dispel concerns about transfats can offer some reassuring help for us today.

Elaine Blume, now Senior Science Writer at the National Cancer Institute of the National Institutes of Health, wrote an article, “The truth about trans: hydrogenated oils aren’t guilty as charged - trans fats,” and its science was surprisingly solid and remains so today. No evidence has ever shown transfats to be a public health concern in the amounts we eat them. Even rats fed extraordinarily high concentrations for 46 generations lived normally and just as long as other rats. Interestingly, her article had been published and distributed by the Center for Science in the Public Interest (CSPI), the same group now leading the scares that transfats are bad for us.

What may be leading consumers to feel that fears about transfats were confirmed was the FDA’s ruling that transfats be added to food labels. But it is important to look behind the spin and read their July 9, 2003 ruling closely and understand what it really said and what was behind it. They were careful to word it to make it clear that transfats were like saturated fats in changing cholesterol levels and they downplayed any actual proven health problems. They specifically noted that eliminating transfats from our diet was not necessary and that their ruling wasn’t banning their use or setting recommended dietary intakes. There wasn’t any credible evidence for that.

But they did something very unusual for an FDA ruling that normally would have been based solely on the soundness of the scientific evidence. Their 260-page ruling [an abbreviated version for consumers is here] explained that it was done “in part to a citizen petition from CSPI on February 14, 1994” and the subsequent 1,720 letters it had received. The FDA had been targeted by a well-organized media campaign and legal intimidation led by CSPI for a decade. It finally gave in.

© 2007 Sandy Szwarc

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

Pediatric Grand Rounds

The new edition of Pediatric Grand Rounds has just been published and has a uniquely fun theme as Dr. Clark Bartram takes readers on a fascinating journey into dreamland. The collection of pediatric articles looks at the scientific reality and debunks popular beliefs about children in this make-believe world, such as food intolerance explanations for general symptoms that lack medical diagnosis, the epidemic of food allergies, the association between ear infections and later developmental problems, heavy metals as causing autism, “poor excretors,” benefits of dietary manipulations in preventing or treating autism, and the labeling obesity and overweight in children. And there’s something about a talking twinky in a cowboy hat....

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

Program cited by the FTC for fraud is now government funded

Three weeks ago, we read of the Federal Trade Commission’s crackdown on fraudulent weight loss products, fining them $25 million. The FTC has filed more than 80 cases in the past ten years against such deceptive weight loss advertising — as many actions as in the prior seven decades combined. How effective have they been?

In a statement to the FTC on October 8, 2002, J. Howard Beales, III, Director, Bureau of Consumer Protection, said: “Even with an increase in enforcement actions by the FTC and other agencies in the past decade, deceptive claims continue to rise.” As Dr. David Klurfeld noted in a November issue of Nutrition News Focus, diet and weight loss makes companies millions of dollars and an FTC letter or a fine still leaves them with substantial profit and little incentive for discontinuing their products.

Throughout the years, five of the country’s largest commercial diet companies have been charged with deceptive advertising for making unsubstantiated weight-loss and weight-loss maintenance claims; for using consumer testimonials without substantiation that the testimonials represented the typical experience of dieters on the programs; and some also for deceptive pricing, weight-loss rate or safety-related claims. Those companies included Weight Watchers International, Inc.; Jenny Craig, Inc.; Diet Center, Inc.; Physicians Weight Loss Center of America; and Nutri/System Inc.

In the Final Decision issued by the FTC (Docket No. 9261) on Christmas Eve 1997, Weight Watchers International, Inc. was ordered to “cease and desist from making any representation, directly or by implication, about the success of participants on any weight loss program in achieving or maintaining weight loss or weight control unless, at the time of making any such representation, respondent possesses...reliable scientific evidence...that:

(1) any weight loss achieved or maintained through the weight loss program is typical or representative of all or any subset of participants of respondent's program..

(2) any weight loss is maintained long-term, said evidence shall, at a minimum, be based upon the experience of participants who were followed for a period of at least two years ...

(3) any weight loss is maintained permanently...”

Since then, no reliable scientific evidence has been produced in accordance with the FTC’s directives. The only trial published was in 2003 in the Journal of the American Medical Association and showed a mere 6 pounds average weight loss after two years but all dieters were gradually regaining their weight after the first year. Nor were results reported on all the participants as attrition rates were so high that one-third had dropped out, but their weight losses were carried forward in the data as having been maintained.

Since the FTC ruling, Weight Watchers International, Inc. became a founding Board member of the National Business Group on Health and its Institute on the Costs and Health Effects of Obesity; a corporate sponsor of the American Obesity Association; a major sponsor of the national launch of the Department of Health and Human Services’ Healthy People 2000; a founding sponsor of the Surgeon General’s Shape Up America!; and a partner in the Partnership for Healthy Weight Management. On January 26, 2007, Weight Watchers International had a $5.16 billion market capitalization (stock value).

Today, the news reports that taxpayers will now fund Weight Watchers. It will be provided free to Medicaid recipients in West Virginia and similar programs are being considered for roll out in California, Colorado Connecticut, Georgia, Indiana, Kentucky, Maine, Missouri, Nevada, New Hampshire, New York, Ohio, Virginia and Wisconsin. It is unknown how much profit this will mean for Weight Watchers, but in West Virginia, Medicaid is the single largest item in the state budget at more than $2.1 billion and in 2002 spent about $140 million on obesity-related treatments.

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Being a fat child a criminal offense

This is an example of the incomprehensible harm that results when myths — in this case about childhood obesity and its causes and dangers — are allowed to perpetuate; and when the myths of the effectiveness and safety of weight loss measures are allowed to persist.

This is a worst case example of what can happen when science is disregarded. The Times UK reports:

‘Fat police’ put children on abuse list

SOCIAL workers are placing obese children on the child protection register alongside victims thought to be at risk of sexual or physical abuse. In extreme cases children have been placed in foster care because their parents have contributed to the health problems of their offspring by failing to respond to medical advice.

The intervention of social services in what was previously regarded as a private matter is likely to raise concerns about the emergence of the “fat police.” Some doctors even advocate taking legal action against parents for ill treating their children by feeding them so much that they develop health problems.

Dr Russell Viner, a consultant paediatrician at Great Ormond Street and University College London hospitals, said: “In my practice, I can think of about 10 or 15 cases in which child protection action has been taken because of obesity. We now constantly get letters from social workers about child protection due to childhood obesity.”...

Dr Alyson Hall, consultant child psychiatrist at the Emmanuel Miller Centre for Families and Children in east London, said that in some cases children were put into foster care to ensure their safety....

Earlier this month two brothers were convicted of causing unnecessary suffering by letting their dog become obese. The labrador, Rusty, was 11 stone, more than double the weight he should have been, and could hardly stand. “We wonder whether the same charge should be applicable to the parents of dangerously obese children,” said Dr Tom Solomon, a neurologist at Royal Liverpool University hospital....

Tam Fry, chairman of the Child Growth Foundation, a charity that fights childhood obesity, agreed. “It should be a punishable offence,” he said. “Very obese children are taking up NHS resources that should be used for legitimate purposes. Parents have got to be held accountable for overfeeding their children or letting their children become fat without taking action.”...

There is only one word for this news story:

Prejudice --

1. injury or damage resulting from some judgment or action of another in disregard of one's rights; especially detriment to one's legal rights or claims

2 a. preconceived judgment or opinion; an adverse opinion or leaning formed without just grounds or before sufficient knowledge

b. an instance of such judgment or opinion

c. an irrational attitude of hostility directed against an individual, a group, a race, or their supposed characteristics

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Dare we believe what a study says if it was industry-funded?

Examples are being volleyed from all sides of this debate. We can find some of the best, most meticulous, carefully-conducted research with responsible conclusions and interpretations of the results that has been funded by industry. Really! We can find equally good studies or perfectly dreadful ones that don’t appear to have corporate interests. We also can find the best analyses that alert us to unsound studies coming from those outside the fray altogether. By making blanket assumptions because of the source, we can shoot ourselves in the foot and never learn what the best science shows. What’s most needed is critical thinking...

A recent commentary in a food technology publication brought some industry points to this issue that aren’t often considered in the popular rush to distrust anything from industry. In an article called “Death to the industry conspiracy theories,” reporter Stephen Daniells, Ph.D., wrote: “Let’s just think about this for a moment....when industry plans to fund a study, it is natural that it would select a product with a potentially favorable nutritional profile...if industry gives you a project then it’s more likely to succeed than not.... proposing paying for a clinical trial into unfavorable effects won’t make you too many friends at a company.” And concerning the phenomenon of publication bias, where more favorable results are published than negative or null results, he said: “these may go unpublished for a variety of reasons – a null or negative result may mean the company goes back to the drawing board (no need to draw attention to something that doesn’t work); or a null or negative results, while no use to the company, may alert competitors to sensitive areas of research.”

The simple fact of the matter, he said, is research has to be paid for by someone and transparency is imperative, but that “should not be used against [authors] because they report positive or favorable results.”

It’s important to take this a step further. When we do encounter mischief in a study’s methodology, or conclusions and abstracts that don’t match what the study data show, or the importance of a study being exaggerated and its results overstated, then more often than not, something is motivating that. If close examination of a study makes you wonder: “What were they thinking?” or “How on earth did this get published?” that’s when understanding the “why” and potential influences can be helpful. The challenge for consumers, healthcare professionals and policy makers is that those interests are often not evident, nor are they always found in financial disclosures. This latter point is often overlooked.

Industry isn’t the only source of conflicts of interest, either, although it’s the one getting the most attention. Nonprofits, advocacy organizations and foundations that may sound well-meaning and beyond reproach, are shaping things more than most people realize. They typically have extensive financial and political interests behind them which can be challenging to discern. More than 90% of foundations in the United States award grants in the health field, about $4.6 billion in 2000, according to the Center on Philanthropy and Public Policy.

By believing that financial interests are the only ones that might lead a study to have bias also means we could be lured into a false sense of confidence and miss some of the most flawed studies with agendas behind them that aren’t always easy to spot. Non-transparent motivations that could affect objectivity can even be unintentional and unconscious. Researchers are not evil and corrupt just because they might conduct poor studies. Remember that recent Nobel prize winner story? Recognition and acceptance by one’s peers, prestige and notoriety, academic promotion, continued funding for a life’s work and even the personal beliefs and agendas of a researcher can cloud the picture and influence even the most well-intentioned studies and their interpretations.

Studies announced to the public and medical community through PR firms and media marketing campaigns can often be a good clue for us that a study may be motivated by something other than objective science. But not always! And few of us fully grasp the extent and marketing techniques used today, so we can even miss a lot of marketing passed off as science. The lines between marketing and education or advocacy are becoming increasingly blurred. While studies published in peer-reviewed journals tend to be stronger, and most certainly have proven to be sounder than those generally presented at meetings, publication does not guarantee a study’s soundness, either. Peer-reviewers and publishers can also have their own biases. And as we see daily, a lot of poor research gets published, funded and supported!

The bottom line is, the source of a study is not what it important, it is the quality of the research itself. Not all studies are created equal. That’s why to protect ourselves, it is imperative for us to learn basic skills in how to look at studies and media reports with a critical eye. Another valuable aspect of the scientific process is that it builds a body of credible, replicable evidence over time, meaning we are best served by not letting ourselves become frightened by something a single study might suggest. Please, let’s be careful out there!

© 2007 Sandy Szwarc

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

Some bones to pick

A post by Ariel Feldman at the Splendora Style blog — a website based in San Francisco with notes about salons, spas, boutiques, restaurants, vacations spots, and things hot in chic — asks why more aren’t concerned with today’s obsession with thinness and how much girls are exposed to its pressures.

It’s a rant from a female perspective that offers some food for thought.

Pro-Ana/Mia: Where Did This Freakish Cult Come From?

So I was browsing...and found myself in the middle of a heated discussion. The group, which is for the abolishment of Pro-Ana cults (just want to make that clear) lists the top websites for "Ana/Mias" and... I couldn't truly figure out what all the fuss was about until I got to this quote from a girl about my age:

"You can learn to love anything, I think, if you need to badly enough. I trained myself to enjoy feeling hungry. If my stomach contracts, or I wake up feeling nauseated, or I'm light-headed or have a hunger headache, or better yet, all of the above, it means I'm getting thinner, so it feels good. I feel strong, on top of myself, in control. "

I actually think I almost yelled out loud at my computer screen upon seeing that. Seriously, if you're not appalled, re-read that again and then let me know what you think....

...I don't want to go on and rant about this, and believe me I can (If you've read any of my other posts you know the only thing I tend to DO is rant...), but I feel this speaks for itself. The anorexic movement circa Kate Moss in the early 90's is so not over with. In fact, it's probably worse than it's ever been before, and as a teenage girl with friends that are at the most vulnerable age to be affected, I'm worried. I'm worried because if no one had brought this to my attention in the first place, I wouldn't have known about it. I'm worried because if this isn't being brought to the attention of myself or other girls my age, then who does know about it? Who knows about these girls that are building these websites and clearly struggling with some pretty heavy shnikey? And who, if they already know, is pro-active enough to do something more than say that there's a problem? Feeding them Mickey D's won't help, and clearly that's not even an option.

I'd like to know the answers to those questions, but more importantly I'd like people other than myself to read those forums and have some type of reaction....Yes, they look sick; that's the point. What happened to empathy? Since when do we look at girls who are literally BONES and disregard it because that seems to be the norm? Perhaps it's not just these girls who are suffering from a sickness—perhaps its a possibility that our over-exposure to spindly shots of MK and Ms. Bosworth are, frankly, warping our minds.

All I can say is someone better figure out what's sparking this skinny pandemic, and figure it out fast, 'cause the next thing you know the government's gonna start banning fries and make trans-fat illegal...

...oh wait, they already did.

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

Hidden truths about hidden fats — a special note for women on the latest scare

This past week, women were threatened that eating fats hidden in processed foods — even as little as a single donut or serving of chips — could harm their chances of having a baby. The study behind this news story showed nothing to support such a claim. But it appears already well on its way to becoming conventional wisdom. The news reported:

Food fats threaten women’s fertility

Scientists warn that hidden fats can increase the risk of fertility problems by 70 per cent or more. Fats hidden in thousands of foods can harm a woman’s chance of having a baby, scientists said yesterday....Eating as little as one doughnut or a portion of chips a day can have a damaging effect.

The scientists behind the study advised women who want to have a baby to avoid the fats, known as trans fats...Nutrition campaigners said the research provided ‘considerable new weight and urgency’ for trans fats to be banned.

This last sentence may be the actual point of the story, but if you are wanting to become a new mother, you just want the facts, not the political-driven scares.

The study behind this news story was published in the American Journal of Clinical Nutrition and was conducted in Boston at Harvard School of Public Health and Brigham and Women’s Hospital. If you’re a regular reader of this blog, you know that this group is famous for its data dredges and this was another one, with all of the concurrent weaknesses. They culled through a database of food-frequency questionnaires looking for correlations between types of dietary fats and pregnancies among a subgroup of women in the Nurses Health Study who said they had been trying to get pregnant for longer than a year.

There were 438 women who had problems conceiving due to ovarian causes. That is your Trojan number. The data from them were compared to that of married women with planned pregnancies.

So, what did the authors find? That the more total fat the women ate, the less likely they were to have problems conceiving. Those eating lower fat were more likely to have problems getting pregnant. Each quintele of higher fat intake was associated with an improved ability to conceive. (Saturated fats had a 31% reduced risk of infertility for the highest compared to the lowest consumptions.) Boy, you didn’t hear that in the news!

Not only that, but the type of fat made no statistical difference. Saturated, monounsaturated, total polyunsaturated, omega-3 and omega-6 fatty acids were not associated with ovulatory infertility. Nor was dietary cholesterol.

The only newsworthy correlation they could create was an untenable relative risk that wasn’t outside what could have mathematically popped up by random chance or statistic error. They claimed that “an increase of 2% in the intake of energy from trans-unsaturated fats, if substituted for carbohydrates was associated with a 73% higher risk of ovulatory infertility.” Not only is this an uncredible relative risk that does not equate with clinical relevance to begin with, but it is important to look closely at the wording they carefully chose to use. Otherwise, it’s very easy to come away with the wrong conclusions, as news reports did.

This relative risk associated with transfats, while actually inconsequential to begin with, is not referring to fertility or a woman’s chance of having a baby, as the news reported. It is referring to “ovulatory infertility,” an unusual term these researchers have popularized. There are many reasons for infertility and female factors account for only 32% of them, as Dr. Jairo E Garcia, M.D., associate professor and director of the Fertility Center and In Vitro Fertilization at the Department of Gynecology and Obstetrics of Johns Hopkins University School of Medicine reports. Remember, men are part of the equation!

And within those female causes there are all sorts of things, including the fallopian tubes (damage, blockage), endometrial (such as endometriosis), peritoneal, cervical, uterine (such as fibroids), pelvis (such as adhesions), ovaries (such as cysts, ovulation disorders and hormones), thyroid problems, medications, and other medical conditions such as amenorrhea (pituitary tumors, excessive exercise or excessive dieting). So, they are claiming a relative risk not of overall infertility, not just female causes, but only for ovarian factors within those. This week’s study is probably beginning to sound much less worrisome. But there’s more.

The phrasing of an increase of “2% in the intake of energy from transfats” sounds like the merest morsel of transfats increases your risk by 73% because 2% doesn’t sound like much at all. Neither the researchers nor the mainstream media made any attempt to clarify this misconception. I’ll leave the reason for that for you to surmise.

As all nutrition scientists and health professionals know, according to the FDA, the amount of transfats Americans eat is about 2.6% of total calories. So increasing that by an additional 2% would be nearly doubling the amount of pure transfats we would have to consume. But that is not ever likely to happen, anymore than eliminating them, and these researchers know that most of all.

Why? Because it was Harvard researchers, including Dr. Walter C. Willett in this study, who documented and reported in the New England Journal of Medicine last year that the average amount of transfats eaten by Americans has not changed since the 1960s.

Yes, contrary to all of the panic we hear about transfats, we are eating the same amounts we have for nearly half a century. While transfats in margarines dropped with softer versions, they increased in baked goods and other foods.

Meanwhile, the actual health of Americans has greatly improved and we’ve gained more than seven years in life expectancy. Heart disease; most cancers, including colon cancer; and premature deaths have been dropping for more than 50 years. Overall mortality from heart disease alone has dropped by half since 1960, according to the latest U.S. 2006 National Center for Health Statistics, National Vital Statistics Reports. And, according to Dr. Garcia, the fecundability (the chance of getting pregnant each month) remains fairly constant among the population and is about 0.22/month.

That’s why the FDA, after years reviewing all available evidence on transfats, said in its July 2003, 260-page ruling (Docket No. 94P-0036), that any fears of a public health concern from the small amounts of transfats in our diets were not supported by the evidence. These fatty acids, in reality, haven't been shown to be better or worse than any other dietary fat. The FDA expert panel specifically stated that transfats needn’t be eliminated from the diet and they refused to establish a daily recommended intake due to lack of evidence.

Transfats make up a tiny part of the fats in our diet (we eat 5 times more saturated fats) and they have never been shown to actually harm health in human studies. At high levels (beyond real-life consumptions in many such studies), the most they have been shown to do is temporarily increase blood “cholesterol” levels. But such changes in blood chemistry haven’t been shown to increase heart attacks, cholesterol in women most of all. [Remember to be cautious of false surrogate endpoints.]

“None of the eight human population studies comes close to linking transfats with heart disease,” said Steve Milloy, now adjunct scholar with Competitive Enterprise Institute and publisher of Junkscience.com. His critical examination of the scientific evidence was an good look at what the studies actually found, the researchers, and how the public was been misled.

Professor David Klurfeld, chairman of the Department of Nutrition and Food Science at Wayne State University, editor-in-chief of the Journal of the American College of Nutrition wrote a special series of articles in Nutrition News Focus examining the evidence on transfats. He concluded that any association between transfats and health problems is weak. For example, he noted that the Nurses Health Study, conducted by Harvard researchers, has failed to find a link between transfats or any other dietary fats and heart disease in more than 20 years.

In this week’s study, the Harvard researchers said infertility might be another reason to avoid transfats but that it wasn’t clear how transfats might affect ovulation and fertility. Just two months ago, the Harvard researchers reported another dietary correlation from the Nurses Health Study: higher iron intakes were associated with improved fertility.

With their new finding that higher dietary fats and saturated fats are also associated with improved fertility, those burgers don’t seem so “bad” for you.

© 2007 Sandy Szwarc

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A cautionary tale of poor science, politics and money gone astray

The media reports were all in favor of the program, public officials funded it with massive amounts of taxpayer dollars, legislators were honored for bringing it to the public, credentialed experts endorsed it, and there even seemed to be lots of science-sounding studies to back it up. It all seemed so good and intuitively right.

The only problem was, it defied plausible, rational explanations in proven science. It didn’t have any credible evidence that it was effective. There was, however, evidence for potential harm by following it.

Yes, this could be describing weight loss programs, but it also describes a lot of other things.

There was a recent story in the news that I thought might be helpful to write about. I thought it would just be a quick, little reassuring explanation of a needless food fear and untenable alternative therapy. But the more I delved into it, the bigger it got and the more uncomfortable I became. If it weren’t for the fact that it might be hurting people, especially kids, and costing all of us, it would have been easier to not say anything....

First the news story

On January 12, 2007, Representative Anna Crook was in the local Clovis, New Mexico newspaper when the Chamber of Commerce honored her with its 2006 Citizen of the Year Award at a black-tie affair. She was recognized for being instrumental in bringing to New Mexico the Second Chance Program, a holistic treatment program for substance abuse inmates. She had secured $350,000 in federal funding for the alternative program in Albuquerque. Another $160,000 in state funds had been earmarked and it had just asked the state for $3.6 million to continue operations.

Earlier in the month, four articles praising the program appeared in publications everywhere, saying “a unique social rehabilitation model is now in place in the criminal justice system of New Mexico, which offers not only drug rehab but also a program that engenders self-respect in the incarcerated as a way to help reduce criminal tendencies.” They were all authored by Kris Nickerson, Editor-in-Chief of Press Direct International, a global web information source for business and media markets. The articles can be read here, here, here and here.

The program is based on “The Way to Happiness” by L. Ron Hubbard, described by Nickerson as “a non-religious moral code.” His DPI articles quoted Dr. Alfonso Paredes, M.D., Professor Emeritus of UCLA School of Behavioral Science as saying:

I have had opportunity to do many visits to substance abuse rehabilitative programs throughout the US for the National Institute on Alchohol [sic] Abuse and Alchoholism [sic] and the National Institute on Drug Abuse. I have had administrative responsibilities for statewide substance abuse rehabilitative systems as well as for programs in major academic institutions in the US. I have never been as deeply impressed as I was during my visit to the Second Chance Program.

The program is also called the Purification Rundown and according to Nickerson, “has been used throughout the world, not only to assist in getting people off drugs, but also to remove chemicals and other toxins from the system and has been used by many of the NY Fire Department and others who worked at Ground Zero after the disaster of 9/11.”

In striking contrast to this press, just days after the Clovis article, Maria Szalavitz of STATS criticized a Wall Street Journal article as being “paralyzed by [a] quack therapy dispute” and failing to report the facts. Exploring further, it is hard to disagree.

The Wall Street Journal had published a cautiously worded article describing a controversy among judges about the Second Chance Program, while noting that 24 New Mexico district judges have already sentenced more than 50 prisoners to the residential treatment program to date. Claims of the program’s success were weaved throughout the 1670-word article. Only at the very end was there a guarded note about possible lack of evidence, saying:

Bill Miller, an addiction expert and retired professor of psychiatry at the University of New Mexico, reviewed Second Chance at the request of the city of Albuquerque. “There's a lot of use of sauna with the idea that you sweat out toxins in the system. I don't know of any scientific basis for that,” he says. “It wasn't clear to me what sort of scientific basis there was even for the conception of the program to begin with.” Does it work? “Basically we just don't know,” he says.

As it turns out, there is a lot of information known about this program — in fact, there are more than 793,000 websites discussing it. It’s more incredible that this program has reached the stature it has among government officials, given the body of evidence against it. Here is some of what we didn’t hear.

The Journal described the program as being based on the principles of L. Ron Hubbard (1911-1986), a pulp fiction and science fiction writer who founded the Scientology religion. Hubbard argued that “toxins from drugs and pesticides accumulate in the body’s fatty tissues, making it difficult for addicts to kick their habit.” According to the Journal, “saunas and vitamins are intended to purge these residues....Inmates eat organic beef. They choose from an array of vitamins to ingest, including potassium pills if they’re feeling dizzy, or bioplasma pills to offset salt depletion. Inmates addicted to heroin can get a massage, called a ‘nerve assist,’ from another inmate. Scientologists believe nerve assists help drugs depart the body.”

But there are more details on this program available on its website. Detoxifying the body by sweating is one of the core premises of the Purification Rundown program. The program claims to eliminate drugs, heavy metals and other environmental contaminants from the body by heat stress and that at the end of its detoxification program the subjects’ IQ will have risen by 6.7 points and their psychiatric and antisocial behavior problems will have improved. It prohibits use of any psychiatric medication, however.

According to Hubbard, exposure to environmental contaminants leads to them build up in fat tissue and sebum of the skin. Supplementation with large amounts of vitamins, such as niacin, is claimed to cause free fatty acid mobilization and the “metabolism of chemicals,” that large amounts of vitamins and minerals are lost in the sweat necessitating large doses to correct deficiencies, and that large doses of polyunsaturated oils increase excretion of chemicals by “blocking the reabsorption of the chemical or altering the rate at which the compound is excreted and the supplements replace some of the mobilized fats so that an exchange is effected.”

Reviews of the evidence

Scientists have been speaking out and debunking these ideas for decades. The detox principles are centered around what proponents say is a medical specialty called clinical ecology, which holds that many common psychological and physical health symptoms can be triggered in sensitive people by low-levels of exposure to environmental chemicals or foods. According to William Jarvis, Ph.D., President of the National Council Against Health Fraud, these beliefs were popularized in a book by David Steinman titled, Diet for a Poisoned Planet, which espoused dangerous toxins were lurking in our foods.

In 1981, the California Medical Association published a position that clinical ecology is not a valid medical discipline and its claims are not supported by scientific and clinical evidence. The American Academy of Allergy and Immunology and the American College of Physicians followed suit in 1986 and 1989, respectively. The American College of Physicians stated:

Review of the clinical ecology literature provides inadequate support for the beliefs and practices of clinical ecology. The existence of an environmental illness as presented in clinical ecology theory must be questioned because of the lack of a clinical definition. Diagnoses and treatments involve procedures of no proven efficacy. Case reports by clinical ecologists and evaluation of these patients by other physicians indicate that this diagnosis is applied most frequently to persons with symptoms of physiologic (somatic) or psychologic dysfunction, or both.

An FDA Talk Paper on October 15, 1990 pointed out its invalidity and potential hazards. But fears about minute amounts of contaminants in our foods and environment have only grown more widespread. As have detox and purification diets and treatments, some with very real risks.

Hubbard’s detox programs have been around for decades, all virtually identical programs under various names such as Second Chance, Inc., Criminon, Narconon, and the New York Rescue Workers Detoxification Project (and New York Firefighters Detoxification Project). One of the best known based on these principles is Narconon, founded by an inmate of Arizona State Prison in 1966. Like Second Chance, Narconon centers are now scattered across the country and number more than 100 worldwide. The largest Narconon drug and alcohol treatment facility, and its international training center, is in Arrowhead, Oklahoma. Tuition for its students is $21,700 (in 2003) for an average of 2 to 3 months. The Church of Scientology says it has provided major financial support to the Narconon programs since their inception.

An especially prolific collection of medical expert analyses of the detox drug treatment program and the evidence behind it was published from 1989-1991, when Indian Health Services and the Oklahoma Board of Mental Health and Substance Abuse Services was asked to license and approve a center at Chilocco, Oklahoma. The State Health Planning Commission as part of the Chilocco Development Authority had leased property to Narconon stipulating its program had to be state approved and certified, and in turn the five Indian tribes involved would receive $16 million in lease payments over 25 years. It sparked tremendous debate and public commentary, and public hearings on the science, safety and effectiveness of the treatment. The scenario was chronicled by multiple tribal groups, as well as by the Vice President of Australian Skeptics, Peter Bowditch, who has followed these programs around the world.

The supportive evidence for clinical ecology and the Purification Rundown principles provided by the Hubbard detox programs remains unchanged today. The papers cited may look impressive but their relevancy and credibility aren’t. Here are a few of the expert opinions on that evidence and claims:

[I]n general, because of a lack of empirical data, the "Purification Rundown" concept cannot be considered medically sound. — Everett R. Rhoades, M.D., Assistant Surgeon General

[T]here is an absolute lack of data to support his assertion that the Purification Program succeeds in doing what the presently adopted programs fail to do. The documents reviewed also contain many truths and half-truths....Overall, the program proposed by Mr. Hubbard is pure unadulterated "cow pies." It is filled with some scientific truth but mainly is illogical and the conclusions drawn by Mr. Hubbard are without any basis in scientific fact. — Bruce A. Roe, professor and director of the Department of Chemistry and Biochemistry, University of Oklahoma, Norman

[I]n reference to other nutritional faddists, i.e., the megavitamin myth...Excesses of Vitamin A can cause brain swelling (pseudotumor cerebri) with transient losses of vision. Niacin does increase vascular circulation but in the acid form, it has been linked to high bilirubin (jaundice) and liver damage. The appropriate use of niacin is in deficiency states. Excessive use can be toxic to the liver....Excesses of various minerals can cause GI problems and, of more concern, can cause kidney problems including kidney stones. Basically, Hubbard's theories are ...theories without controlled proof. He flings facts around wildly in excess, i.e., to drown the reader in facts in order to convince him that he knows. But he has little to reference and document the facts. — William B. Svoboda M.D., Neurology & Epileptology, Wichita, Kansas

My recommendation about detoxification is to keep away from it. You don't need it. I'm not sure it does what this book describes. It's dangerous. I don't think L. Ron Hubbard has credibility in the scientific world. The author's suggestions about detoxification can be detrimental to your health. — C. Everett Koop, M.D.

I think that it is fair to say that the Purification Rundown is without merit....There is certainly no scientific documentation that exercise significantly speeds up the detoxification process. A significant portion of the Purification Rundown is devoted to running and Sauna Treatments from four to five hours a day. The author states throughout, that sweating increases the rate at which drugs in general leave the body. This is certainly untrue of many drugs, as most drugs of abuse are eliminated from the body by detoxification through the liver, or by passage through the kidneys, or occasionally by passage through the lungs....The author's recommendation for taking Vegetable Oil to replace the oil in our fat tissues that are contaminated with drugs has no documentation or basis in fact....There is no scientific documentation that niacin in any way gets radiation out of the body....In addition there are aspects of the program which I find medically unsafe. — Mark Palmer, M.D., Internal Medicine,Ponca City, Oklahoma

As a member of the board of directors of The National Council Against Health Fraud and a diplomat of The American Board of Nutrition, I am an expert at separating fact from fraud in the nutrition field....the scientific evidence shows the exact opposite of what Hubbard's theory predicts. There is no credible support for claims that large doses of niacin clear toxins from the brain, fatty tissue or any other part of the body. To make matters worse, large doses of niacin are hepatotoxic and can cause serious liver damage. It may also trigger gout, raise blood sugar into the diabetic range, cause itching, flushing and a rash. Nausea and gastritis are other side effects of large doses of niacin. To subject people to these potentially serious side effects on the pretense that they are being "detoxified," "cleared" or "purified" is quackery. — James J. Kenney, Ph. D., R.D.

There is no evidence at all that L.S.D. or any of the other street drugs Hubbard mentions "lodge in the tissues for years." Indeed, these drugs, being water soluble, are excreted quickly....No vitamin deficiencies are due to a toxic effect of street drugs...It is of historical note that no one received a Nobel prize in 1973 for "curing insanity with niacin," as Hubbard claims....Vitamins A and D, if taken in large doses, may be quite harmful....He consistently demonstrates a complete and at times dangerous lack of knowledge concerning biochemistry, physics, and medicine. His theories are based on fallacies and lies; there is no scientific data to support any of them. Furthermore, his program not only fails to deliver what it promises, but may actually be detrimental to the health of those taking it. — David Hogg, M.D., Toronto

There have been multiple official evaluations of the evidence on these detox programs, archived by Australian Skeptics, such as by doctors with the State Department of Health in Sacramento, California in October 1974; the Michigan Ionia State Prison, Department of Corrections in April 1980; and the Swedish National Board of Health and Welfare in November 1996. Professor Folke Sjoqvist, Scientific Advisor of Clinical Pharmacology for the Swedish National Board of Health and Welfare summarized their findings stating:

As evident from this compilation, there is no documentation to show that the Hubbard method of detoxification from drug abuse conforms to scientific standards and medical experience.

For decades, Narconon literature around the world has claimed to have a 78.6% to 85% effective rehabilitation rate. Typically no evidence is provided but when it is, Narconon-commissioned reports are cited. A Swedish investigation of one such report in 1981 found the claims to be false and that only 23% of participants had actually completed the program, with only 6.6% saying that they had remained drug free for one year afterwards.

After hearing the evidence presented at several hearings, the Oklahoma State Board of Mental Health released is Findings of Fact on December 13, 1991. After describing the evidence in detail, it concluded:

Drug treatment program offered by Narconon-Chilocco is an experimental treatment and not proven safe or effective and is not in accord with the highest standards accepted in medical practice as required by statute. No scientifically well-controlled independent, long-term outcome studies were found that directly and clearly establish the effectiveness of the Narconon program for the treatment of chemical dependency and the more credible evidence establishes Narconon's program is not effective. The Board determines that the Narconon Program is not effective in the treatment of chemical dependency. The Board concludes that the program offered by Narconon-Chilocco is not medically safe. Certification is denied.

So what happened? After years of lawsuits, the Oklahoma Board of Mental Health and Substance Abuse Services finally capitulated and exempted the Narconon facility in Chilocco from its requirement to be certified by the state on September 20, 1992. Narconon eventually moved to the Arrowhead location, where it is today.

School children programs

Hubbard detox programs, notably backed by lawmakers despite no new credible evidence, are now found across the country, including prevention and education programs for school children. Few school officials have investigated these anti-drug programs that had been in schools across the country for two decades. But in 2004, San Francisco and Los Angeles school superintendents called for an extensive scientific review of the health curriculum of Narconon Drug Prevention and Education programs that had been being taught in at least 34 California districts.

San Francisco Chronicle writer, Nanette Asimov, wrote a recognized series on those programs that summer. No medical doctors or substance abuse experts were able to find any evidence to support the program’s claims. Parents and medical experts were especially concerned with her report, “What Narconon tells students.” The children were being taught that drugs and chemicals were locked up in body fat and could cause mental and physical symptoms for years and make their body toxic, necessitating sweating out in saunas to release. Maria Reza, Los Angeles’ assistant superintendent of student health and human services, sent a memo to all Los Angeles schools halting use of the program pending the review, saying: “The information that is delivered in (Narconon’s) presentations is not based on science, and there have been serious questions raised about the accuracy of this information.” Children do not need to fear that being fat or that their fat friends are harboring toxic chemicals causing them any harm.

In October 2004, the findings of the extensive investigation were released. According to Steve Heilig, director of health and education for the San Francisco Medical Society, the Narconon Drug Prevention and Education programs exemplified “non evidence-based and sometimes factually inaccurate approach, which has not served students well for decades.” As the Chronicle reported: “The medical experts minced no words in their harsh assessment of Narconon.”

Heilig said: “One of our reviewers opined that this (curriculum) reads like a high school science paper pieced together from the Internet, and not very well at that... and that the curriculum contained ‘factual errors in basic concepts such as physical and mental effects, addiction and even spelling.’” According to the Chronicle, a Scientology spokeswoman said that Narconon was the secular version of their religious purification regimen and “at least 39 school districts have recently hosted Narconon in the classroom.”

Including in New Mexico, which is part of Narconon Rio Grande, Inc. based in Rio Rancho and incorporated since May 4, 2001. The Narconon program organizes presentations for children in grades two through 12 in Bernalillo and Sandoval county schools. PNM granted Narconon $7,500 in 2002, enabling the program to reach 8,000 New Mexico students.

Political support

Across the country, Hubbard programs are being prominently funded and endorsed by public officials, although their actual natures are rarely identified.

The U.S. Senate Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Bill, 2007, recommendations include $60 million for “responsible reintegrations of youthful offender programs.” It commends the work of the Second Chance Program, saying: “The Committee expects the Department to support Second Chance through funding to expand and replicate its recidivism prevention program.”

The Second Chance Program brochure for the La Mesa, California location includes endorsements from six Arizona Senators and Representatives.

As the Clovis News Journal reported, Representative Anna Crook said she’s worked with legislators across the country to implement the Second Chance program. She is a member of the National Foundation for Women Legislators and its National Policy Committee on Crime, Justice, Terrorism and Substance Abuse. The National Foundation for Women Legislators is supported, at its highest “Leadership Circle” level, by the Second Chance Program.

In the May 2005 issue of the NFWL newsletter, The Connection, Representative Anna Crook was noted as Chair of the Crime, Justice, Terrorism & Substance Abuse Sub-Committee on Prison Reform and said she had “met with Governor Bill Richardson to discuss the facility’s successful history in Mexico and other locations and to encourage its establishment in New Mexico.” The program in New Mexico would accept not just inmates, but also Native Indian peoples, she said. According to Governor Richardson’s Campaign Reporting Act filing with the Secretary of State, the Second Chance Program had donated $1,000 on July 25, 2006 to his 2006-2007 election campaign. Robert J. Desiderio, former Dean of the University of New Mexico School of Law and former executive director of Con Alma, was registered as a State lobbyist employed by Governor Bill Richardson and Second Chance Program throughout 2006. The Governor announced on January 15, 2007 “a far reaching package of proposals to combat substance abuse in New Mexico through law enforcement and treatment funding.” It is unclear from the “more than $20 million in substance abuse prevention and treatment funding” how much was to go to Hubbard programs.

The center in Albuquerque opened its doors in October, 2006, according to a press release. A local KRQE News investigation of the local Second Chance Program reported it found only a drop box at the office location listed in their brochure.

According to the KRQE investigative report last September, the $100,000 allocation of state moneys for Second Chance had originated from a request by the Governor and the $60,000 for Highlands University had been brokered by former Highland’s president Manny Aragon. But in light of the media attention, KRQE said the $160,000 in state moneys were being returned to the general fund and wouldn’t be going to Second Chance in Albuquerque.

Interestingly, the comments on television made by Dr. Miller, the UNM clinical psychologists quoted in the Wall Street Journal, were considerably stronger than those in the Wall Street Journal. He told local viewers that the program’s claims of effectiveness “are fairly outrageous claims well beyond anything that’s been documented in the literature and of the programs methods, he said: “They certainly aren’t coming from a scientific basis.”

The history of health care is filled with well-intentioned interventions that have received large amounts of government funding and the support of top officials and experts. But that is never proof that they have been carefully researched and shown to be sound, effective ... or safe.

© 2007 Sandy Szwarc

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Change of Shift

The latest issue of Change of Shift is up at Emergiblog. Kim has compiled a varied collection of essays from nurses. Some are sure to leave you feeling as exhausted as the nurses did after working endless 12 hour shifts.

A story I found especially moving was by Erica at Blissful Entropy who wrote about nurses' instincts. She has learned to trust her gut when something doesn’t feel right. She described two situations with children in the ER and the difficult decision of whether to call child protective services when signs seem to point to abuse. The heartbreaking details of what she discovered will stop your heart, too.

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The Great Cholesterol Con

The Daily Mail reports that the long-anticipated release of The Great Cholesterol Con by Malcolm Kendrick, Medical Director of Adelphi Lifelong Learning, Cheshire, UK, and long-time cholesterol researcher, is January 29. Dr. Kendrick writes:

Have we been conned about cholesterol?

...So how can I say saturated fat doesn't matter when everyone knows it is a killer? Could all those millions who have been putting skinless chicken and one per cent fat yoghurts into their trolleys really have been wasting their time? The experts are so busy urging you to consume less fat and more statins that you are never warned about the contradictions and lack of evidence behind the cholesterol con. In fact, what many major studies show is that as far as protecting your heart goes, cutting back on saturated fats makes no difference and, in fact, is more likely to do harm.

So how did fat and cholesterol get such a bad name? It all began about 100 years ago…Major trials since have been no more successful. One involved nearly 30,000 middle-aged men and women in Sweden, followed for six years. The conclusion? "Saturated fat showed no relationship with cardiovascular disease in men. Among the women, cardiovascular mortality showed a downward trend with increasing saturated fat intake." (In other words, the more saturated fat, the less chance of dying from heart disease).

It's a bit of a paradox, isn?t it? That's one of the features of the dietary hypothesis - it involves a lot of paradoxes. The most famous is the French Paradox. They eat more saturated fat than we do in Britain; they smoke more, take less exercise, have the same cholesterol/LDL levels, they also have the same average blood pressure and the same rate of obesity.

And you know what? They have one quarter the rate of heart disease we do. The official explanation is that the French are protected from heart disease by drinking red wine, eating lightly cooked vegetables and eating garlic. But there is no evidence that any of these three factors are actually protective. None. By evidence, I mean a randomised, controlled clinical study…

The Framingham study in the US found that people whose cholesterol levels fell were at a 14 per cent increased risk of death from heart disease for every 1mg/dl. Set up in 1948, the study screened the whole population of Framingham near Boston for factors that might be involved in heart disease and then followed them to see what happened to them. It is still going today, making it the longest running and most often quoted study in heart-disease research. A massive long-term study that looked specifically at cholesterol levels and mortality in older people in Honolulu, published in The Lancet, found that having low cholesterol concentration for a long time increases the risk of death.

Low cholesterol levels greatly increase your risk of dying younger. So the cholesterol hypothesis looks something like this: There is no evidence that saturated fat is bad - and there are lots of 'paradoxes' where countries with a high cholesterol intake don't have a higher death rate from heart disease....

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