Junkfood Science: January 2008

January 31, 2008

War on obesity a success in England, but not for England

The Information Centre’s latest Health Survey for England report, Statistics on Obesity, Physical Activity and Diet: England, January 2008, has just been released. It provides evidence that the war on obesity has been enormously successful ... for its corporate sponsors.

The number of prescriptions for weight loss drugs in England increased 800% from 1999 to 2006, to 1.06 million. Those skyrocketing figures show no sign of abating — the first half of 2007, the latest period data is available, were another 25% over the same period in 2006.

The costs of these diet drugs alone, born by the already financially strained national healthcare system, increased from £4.9 million to £47.5 million (that’s $94.5 million in U.S. dollars) from 1999-2006, while the price per prescription rose from £38 to £45. Orlistat costs rose the most.


Most of these prescriptions were for two drugs: Orlistat (73% of prescriptions) and Sibutramine (25%). What makes this so disturbing, besides the fact that the effectiveness of these drugs for weight reduction has been nominal, at best, in short-term trials, is that there is no evidence these drugs are safe for long-term use. Worse, these drugs have been approved for use with no evidence that they reduce premature deaths or reduce actual health problems. Nor is there evidence of long-term effectiveness or safety.

Their use is controversial and has been called into question by doctors and independent medical advocacy organizations around the world, as recently reported here. For example, a systematic review of fourteen randomized, placebo-controlled trials among adults with type 2 diabetes led by Dr. Susan Norris, M.D., of the Centers for Disease Control and Prevention; as well as a review by doctors at the University of Alberta Hospital in Edmonton, Canada, both expressed concern about the short-term trials, all of which have shown only minimal temporary weight loss; the lack of long-term safety data; and the significant adverse effects already seen with short-term use. Those include gastrointestinal problems with orlistat and high blood pressure and heart rate problems with sibutramine.

The U.S. Federal Trade Commission convened an expert panel to review the evidence for its 2003 investigation into deceptive weight loss advertising. Concerning orlistat (Xenical), the panel’s scientists concluded: “The biological facts do not support the possibility that sufficient malabsorption of fat or calories can occur to cause substantial weight loss.”

Diet drugs have a universally poor history of effectiveness and an even worse one for long-term health problems. But, sadly, it’s not hard to understand why people have come to feel so desperate to lose weight that they would consider risking their health to take drugs with such poor evidence. Nonstop threats directed at fat people have saturated media for years, reporting frightening stories of premature deaths and disease, denial of needed healthcare, and discrimination in consideration for jobs to adoption of children.

It’s also not hard to understand why doctors have come to believe that these drugs are effective and advised, because such information fills the medical literature. The pharmacological management for obesity has also been incorporated into the National Institute for Health and Clinical Excellence (NICE) guidelines — the clinical practice guidelines that doctors in the British National Health Services (NHS) must follow as part of their national contracts. It tells physicians: “Drug treatment should be considered for patients who have not reached their target weight loss or have reached a plateau on dietary, activity and behavioural changes alone.” And, as we know, that describes all fat people because ...diets don’t work.

Those same NICE obesity guidelines similarly advise bariatric surgery. And, not surprisingly, the Health Survey for England report found that bariatric surgeries had soared from 121 in 1996/7 to 997 in 2005/6 (all but 19 were on were women) — costing the NHS another £45 in 2006 ($89.53 US. dollars) — an increase of 823%.

Incidentally, diet drugs and bariatrics were among those rising “costs of treating obesity” that the report also accounts. But it pointed out that the increases were also due to a number of reasons, including higher NHS and drug costs, more detailed information (mandatory reporting) and the inclusion of more “comorbidities” into the figures.

As the report explains, the Quality and Outcomes Framework for 2006/07 included a mandate which rewards doctors for maintaining an obesity register of patients (aged 16 and over). “In England, in 2006/07, nearly 4 million people aged 16 and over had been recorded by GPs on obesity registers.”


Sponsors of the obesity crisis

As JFS readers will remember, the creation of the NICE guidelines, like the EU’s Public Health Action Programme, countless public obesity initiatives and this Health Survey report, have involved a range of stakeholders. Prominent among them are the Association for the Study of Obesity (ASO), Obesity TaskForce (IOTF) and the National Obesity Forum.

Professor Peter Littlejohns, Clinical and Public Health Director at NICE who led the development of the NICE obesity guidelines said: “Obesity is the most serious threat to the future health of our nation. Its risks are as serious as smoking and urgent action is needed to tackle this problem now. For the first time we have brought together all the people that can help solve the obesity problem – not just health professionals, but also local councils, employers and schools – to produce a piece of work that sets out the steps we must take as a nation in order to tackle the obesity epidemic.” The EU Commissioner for Health said nearly the identical thing in a 2003 issue of Eurohealth: “Obesity is the major emerging threat to public health in Europe,” he wrote. “Obesity is an issue on which the EU needs to pool its intellectual resources. Addressing obesity is a priority of the EU...Beating the obesity epidemic will require governments, stakeholders at all levels, local, national, European and international, to work together.”

National divisions of these same organizations are here in the United States. These international groups are not independent obesity advocacy or professional organizations, however, as their names might suggest.

The sponsors of the obesity crisis, explained Peter Marsh and Simon Bradle in an investigative report for the Social Issues Research Centre, are pharmaceutical companies whose campaigns are aimed at increasing “obesity awareness” but are nothing but “thinly disguised marketing” for diet drugs:

Dr. Ian Campbell, chair of the UK National Obesity Forum... includes a number of pharmaceutical companies in its list of sponsors who manufacture the drugs that he suggests can play a significant role in stemming the obesity 'epidemic'. Dr Campbell has also been listed on a help line advertised in Roche's 'Obesity Awareness Campaign' materials — a poster campaign criticised by GPs as being a thinly disguised marketing exercise for Xenical.

International Association for the Study of Obesity, of which the International Obesity Task Force (IOTF) is a major part... appear as joint 'working names' in the UK Register of Charities. Both the national organisations and the umbrella international bodies receive extensive financial support for conferences and other activities from the major pharmaceutical companies... The chair of IOTF, which shares offices and funding sources with IASO, is Professor Philip James — a well-known anti-obesity campaigner and a specialist adviser to the Health Committee's inquiry into obesity... was the lead researcher in trials of sibutramine, a weight-loss drug manufactured by the Knoll Pharmaceutical Company, and orlistat (Xenical) made by Roche, and is regularly engaged in what can only be described as PR activities for Roche....

The Health Survey for England report shows just how effective their campaign for an “obesity crisis” has been. Profitable for them, but considerably costly for the public.


© 2008 Sandy Szwarc


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No fat people allowed: Only the slim will be allowed to dine in public!

It has actually happened. Lawmakers have proposed legislation that forbids restaurants and food establishments from serving food to anyone who is obese (as defined by the State). Under this bill, food establishments are to be monitored for compliance under the State Department of Health and violators will have their business permits revoked.

House Bill 282 was introduced in the 2008 Mississippi legislative session on Friday by Representative W.T. Mayhall, Jr., a retired pharmaceutical salesman with DuPont-Merk. Its co-authors are Bobby Shows, a businessman, and John Read, a pharmacist.

The full text reads:

HOUSE BILL NO. 282

An act to prohibit certain food establishments from serving food to any person who is obese, based on criteria prescribed by the state department of health; to direct the department to prepare written materials that describe and explain the criteria for determining whether a person is obese and to provide those materials to the food establishments; to direct the department to monitor the food establishments for compliance with the provisions of this act; and for related purposes. Be it enacted by the legislature of the state of Mississippi:

SECTION 1.

(1) The provisions of this section shall apply to any food establishment that is required to obtain a permit from the State Department of Health under Section 41-3-15(4)(f), that operates primarily in an enclosed facility and that has five (5) or more seats for customers.

(2) Any food establishment to which this section applies shall not be allowed to serve food to any person who is obese, based on criteria prescribed by the State Department of Health after consultation with the Mississippi Council on Obesity Prevention and Management established under Section 41-101-1 or its successor. The State Department of Health shall prepare written materials that describe and explain the criteria for determining whether a person is obese, and shall provide those materials to all food establishments to which this section applies. A food establishment shall be entitled to rely on the criteria for obesity in those written materials when determining whether or not it is allowed to serve food to any person.

(3) The State Department of Health shall monitor the food establishments to which this section applies for compliance with the provisions of this section, and may revoke the permit of any food establishment that repeatedly violates the provisions of this section.

SECTION 2. This act shall take effect and be in force from and after July 1, 2008.

Should this pass, scales will appear at the door of restaurants, people with BMIs of 30 or higher won’t be allowed to be served. And to comply with government regulations, restaurants will have to keep records of patrons' BMIs.

Is this a tongue-in-cheek bill, meant to point out how absurd the war on obesity has become? Or do lawmakers actually believe the myths that gluttony is the cause for obesity and that it is the government’s role to force people to eat and live how it deems best?

I called lead author, Rep. Mayhall, and asked if this was serious legislation or tongue-in-cheek to make a point. He kindly took a moment to answer my question while the legislature was in session. He said that while, regrettably, he doesn’t believe his bill will pass, this is serious. He wrote it, he said, because of the “urgency of the obesity crisis and need for government action.” He hopes it will “call attention to the serious problem of obesity and what it is costing the Medicare system.”

So, yes, this is for real and these elected officials actually believe this stuff.

The time is now for all Americans who value their freedom to eat, look, breathe and live their lives how they choose to unite!



Thanks Dave!


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January 30, 2008

Super Bowl banned for 'causing' heart attacks?

Just imagine, New York Giants and New England Patriots fans might have to find something else to do this Sunday.

The Super Bowl, and all spectator competitive sports, may be a thing of the past, in accordance with current public health policies. A new study has found such sporting events are associated with a 326% increase in cardiac emergencies among men and nearly a doubled risk among women. These are actual myocardial infarctions and cardiac arrhythmias, not surrogate endpoints for heart problems. For those with heart disease, the risks are twice those of people without a history of heart problems.

Calls have already begun to ban all competitive sports to protect public health and contain healthcare costs...

In a study just published in the New England Journal of Medicine, German researchers examined cardiac emergencies during the Fédération Internationale de Football Association World Cup compared with the weeks before and after. Acute cardiovascular events among 4,279 patients in the Munich area increased nearly three-fold among men on days of matches involving the German team compared to the control period. Nearly half of those experiencing cardiac emergencies during the sporting events had known coronary heart disease, compared to about 30% of those during the control period. The researchers said preventive measures were urgently needed.

Canadian emergency room and sports medicine physicians at McGill University Health Centre in Montreal reported similar surges when Canadian teams competed in the Olympics. Games were thought to be too stressful.

Given the precedence of other bans in the interest of public health to prevent risks for heart problems, banning all spectator sports would make the only 'sensible' recourse.

Consider, for comparison, the bans on transfats. FDA’s scientific experts concluded that based on all evidence, eliminating transfats from our diet was not necessary and no research has ever found transfats to increase heart attacks or actual heart disease. Transfats make up a tiny part of the fats in our diet — we eat five times more saturated fats and the amounts we eat haven’t increased for at least the past half century. In fact, said the FDA, transfats have never been shown to actually harm health in human studies. No research has ever shown transfats to be a public health concern in the amounts we eat them. The Nurses Health Study has even failed to find any link between transfats (or any other dietary fats) and heart disease in more than 20 years. At high levels, the most that’s been shown in some studies is that transfats are associated with untenable increased relative risks, primarily for temporary changes in cholesterol levels (surrogate endpoints). Despite the evidence, transfats have been declared by certain public officials as too deadly to be permited in any amounts.

So, compare the correlation between transfats and untenable 0% to 53% higher relative risks largely relying on surrogate endpoints ... to the correlation between sporting events and the 326% higher risks for actual cardiac emergencies, and the answer is clear: All spectator sports must be eliminated for your protection.

It is only logical, right?

:)


Addendum: Clearly, this proposal is tongue-in-cheek. But if this latest sports study actually worried you, please see Dr. Wes for a healthy perspective. As he says: "Watch. Cheer. Socialize. Be Happy."


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TV diet doctor spreading the ‘gospel of healthy living’

Let’s face it. There are a zillion ways to make money selling a diet book. All anyone needs is a gimmick to cut calories, then write how easy your plan is to follow and that everyone is guaranteed to lose weight. Promise they’ll never need to diet again. Be sure to warn about the dangers of obesity and unhealthy lifestyles, then vow that your diet will save them and lead to a healthier, happier and longer life, prevent cancer, promote regularity or even give them youthful complexions. Give impressive explanations that make your plan sound like it’s based on science (no evidence is required as you’ll need only a few anecdotes and inspiring photos). Being able to say you’re a doctor or professor is certain to make people believe you know what you’re talking about. Finally, get endorsements from celebrities or high-profile television shows as they’ll guarantee your diet book will be a best seller. :)

By taking their diets directly to the media and public, TV diet doctors bypass the medical community, as well as any scrutiny that would come if they were published in the medical literature. So, not surprisingly, some of the wackiest fad diets are seen on TV.

But consumers deserve a special alert about the risks that come with one of the fastest-growing gimmicks.

Diets are creating online communities to provide support and send dieters targeted come-ons for other stuff, and the paid sponsors are rarely openly disclosed. The electronic tools that are offered for registered participants promise to track their progress for them online. Dieters type in health and other personal information, food records and weights. These are not unlike product warranty cards or new online medical records. They appear harmless, but the information is put into a database of consumer portfolios and can be sold to marketers, giving vast numbers of people access to your personal information and putting your privacy and safety in jeopardy.

Few people, however, stop to consider what protections are in place when they volunteer personal health information to third parties who aren’t their doctors or healthcare providers. The truth is, there is no protection for how their personal information can be shared, sold and used. And people have no control over what happens with their information. The federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy law does not even apply.

According to the U.S. Department of Health and Human Services, there is no protection for personal health information used by “noncovered entities” (all those other than healthcare payers, clearinghouses and medical providers), and the groups specifically exempt from having to comply with HIPAA privacy protections include personal health record or wellness services and other companies “such as life insurers...” The potential for abuse, such as using the information to financially penalize or deny insurance coverage or benefits, or employment is very real.


Diet challenge

Dr. Ian Smith* — a TV and radio diet doctor, and author of three diet books and diet expert for the VH1 Celebrity Fit Club — has launched a nationwide 50 Million Pound Challenge targeting African-American communities, the goal is 50 million pounds of weight loss among participants. Key to this marketing drive is a 14-city church tour, which began last fall, to the largest and most influential Black churches across the country. According to his press release, it’s backed by numerous African-American leaders, civic and health organizations.**

“In tandem, the online Challenge community and the church can be the ultimate support group,” said Dr. Smith. The African-American community is especially hard hit by ‘weight-related’ health risks, such as heart disease, stroke, cancer, diabetes and other health related problems, he said. His church tour and 50 Million Pound Challenge rallies and gatherings have added to his celebrity.

This Challenge is said to be the largest and most far-reaching national “health” initiative ever directed to the African American community. According to today’s press release, more than 310,000 people have signed up onto its online community thus far. He told Gail King (of Oprah) on her radio show on April 16th, that 80% of African-American women and 70% of men are too fat and he hopes to get 5 million people signed up.

To join the Challenge, participants can only register online, and then record the pounds they lose on its electronic database. In return, they’ll “gain support and motivation by working with others in the congregation on a similar journey.” They’ll also receive a free diet booklet that’s a scaled-down version of his full diet [you can download a copy here, without registering for the Challenge], a CD and pedometer. According to Dr. Smith, this online site will track everyone’s progress and registered users will be sent information and updates throughout the Challenge. “When we reach our goal we plan to let the whole country know about it!”

“We will continue to take the Challenge message and weight loss tools to the people,” he said. “The churches, traditional cornerstones in African-American communities, are a natural pulpit for delivering our important message. I thank our sponsor State Farm for making it possible for us to spread this ‘gospel of healthy living.’”

The sponsor of this 50 Million Pound Challenge is State Farm Insurance. State Farm says on the Challenge website:

Although each company has different underwriting requirements, those who are overweight may pay more for life and health insurance coverage. Losing weight can improve your health and can also help lower your insurance premiums. When you have any changes in your health relating to build, please talk to a State Farm agent about ways to get the right coverage at the right price.

On the FAQ page, State Farm says that the information participants provide in registering for this Challenge and weight tracking “will not be used by State Farm for underwriting or rating purposes.” Under the law, however, they can use this information any way they choose, and for more than marketing.

On the 50 Million Challenge website, State Farm’s Privacy Principles say they do not share customer medical information with anyone unless “it is permitted or required by law” — neglecting to say that the law already permits them to do so. For more information about the privacy of medical information, they merely provide a copy of HIPAA, which few people read closely or understand. There is no evidence that they intend to use this vast database in any way other than to benefit Black communities, but…

Should the potential value of this enormous database of African-Americans, all of whom are “overweight” or “obese,” prove irresistible, be requested for research or marketing by some entity, or become another of the third parties the CDC contracts with in its nationwide data collection efforts... they will be free to use or sell the information, with no recourse for participants.


Fat Smash celebrity diets

Dr. Ian Smith’s latest diet books are the Fat Smash Diet and Extreme Fat Smash Diet. These have helped stars through the Celebrity Fit Club lose weight quickly, he says. On the Extreme Fat Smash diet, Dr. Smith says most people will lose 12 pounds in just 3 weeks.

The Fat Smash diet is a 90-day program with four phases. The diet for the 50 Million Pound Challenge is based on this diet. In the promotional booklet, he says:

With a positive attitude and a willingness to work hard, you can accomplish almost anything you want. This is especially true when it comes to weight loss... One of the most important keys for success is getting your mind in the right place....Losing weight isn’t as complicated as people would have you believe.

He quotes the usual claims about an obesity epidemic and that obesity is linked to cancer. He repeats that discredited claim that 90,000 cancer deaths could be prevented every year if people had a “normal, healthy body weight,” which he defines as a “normal” BMI. And he says that cancers can be prevented by “good eating,” and that certain fruits and vegetables are “cancer fighters.”

The Fat Smash diet is the more conservative of the two. About it, he says:

Diets don’t fail people, rather people fail diets. The Fat Smash Diet is a 4-phase forgiving program that is as much about helping people make the necessary lifestyle changes to lead a healthier, happier, and longer life as it is about getting rid of all of the extra weight.

Dr. Smith and WebMD say that this is a simple plan that’s easy to follow and teaches a lifestyle approach focused on eating healthfully. But this is the furthest thing from a healthful, normal eating plan. It is a strict diet.

Phase One is a 9-day detox period “to rid your body of harmful toxins from processed foods and environmental factors, making it easier to lose weight.” You eat 5 times a day of “mostly fruits and veggies and clean your body and mind of impurities naturally without fasting or putting any toxins into your system.” It is a severely calorie-restricted phase with unlimited amounts of water and only limited amounts of unsweetened decaf herbal tea to drink. You’re also allowed limited portions of plain oatmeal, egg whites, low-fat milk and beans/tofu.

The remaining weeks’ menus begin by determining if you are an “alpha, beta or gamma,” based on how easily you’ve lost weight in the past, and then gives you a menu plan for your “dieting profile.” All foods are low-fat, low-salt and only to be eaten raw, grilled or steamed. Nothing fried. You are not allowed to eat within 1 1/2 hours of going to bed. There is an extensive list of forbidden and allowed foods.

Phase two is called a “foundation” phase when you can add small portions of lean meats to your detox diet. The next phase is called the “construction” phase which lets you add brown rice and whole grain foods with protein. The last phase is the “temple” phase which is supposed to be what you stay on for life and, with portion control, lets you add limited amounts of “white” starches and a few glasses of wine or beer per week.

If you fall off the wagon, you go back and repeat the detox phase and then continue. And if you want to lose more weight you can just keep cycling through the phases again. As one (hungry) reviewer wrote, there is a reason this diet book isn’t called the No Pain Happy Face Diet. Reading the countless diet forums of struggling dieters trying to follow these Fat Smash diets finds people absorbed by weighing themselves and what they can and can’t eat at various phases: beans are okay in phase 1, but not if they’re baked beans; pickles are okay in phase 1 but only 2 a day; veggie burgers are okay but not if they contain bread or cheese; only 2 cups of unsweetened decaffeinated tea is allowed per day; no honey in phase 1 and no more than 1 tablespoon a day in phase 2; no sugar-free jello or peanut butter until phase 3; no fruit juice or diet drinks in phase 1; air-popped popcorn is allowed but no butter or flavoring; etc...


Is there any evidence the Fat Smash diets are effective?

No results have ever been published. These new diets haven’t been around long enough to determine if anyone maintains a clinically meaningful weight loss for 5 years or, more importantly, if they improve long-term health. There is no reason to suspect that these fad diets will be any different than the half century of evidence of endless other weight loss diets. One person on the Fat Smash Forum reports that she’s just recently reached her goal weight.

Nor does any scientific or medical evidence support any of the claims made about detoxification; about special cancer preventive properties of produce or certain healthy foods; many of the claims about popularly-defined healthy eating or the ability of a healthy lifestyle to enable people to live longer; or even for the scare that obesity causes cancer. Nor is there any evidence that online dieting support and communities result in more effective sustained weight loss.


Diets do fail people, no matter how well-intentioned their authors might be. These diets will no doubt make this author loads of money and fame, but at what costs to those who buy his books and work hard to follow these diets, only to gain the weight back?


© 2008 Sandy Szwarc


* Dr. Ian Smith is a TV and radio diet doctor, rather than a practicing physician. The bio on his website describes his appearances in media. He received his M.D. credential from the University of Chicago Pritzker School of Medicine, a 4-year pass-fail curriculum, but there is no note that he ever went on to do the three to seven more years of residency training in order to practice medicine, or any additional fellowship training for any specialty. He is not listed as having a license to practice in Illinois or New York, the states he has listed as residing, or as having a membership in the American Medical Association.

** According to Diversity Inc., more than 50 leaders have joined the effort, including the American Diabetes Association, the Congressional Black Caucus Foundation, the National Urban League, the Institute for the Advancement of Multicultural & Minority Medicine, and the American Council on Exercise.


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January 29, 2008

A real and pure message

An inspirational and compassionate young women is creating this wonderful series of cards. Finally breaking free after a long battle with an eating disorder, the talented teen behind this project said the unrealistic ideals and body images among young women spurred her into action. She just had to do something real and pure to help others. She wanted something different that she thought would be meaningful to others like her.

“I want something with a youthful spirit and made by people who need help the most,” she said. “I want something that I know will legitimately make people feel better about themselves, even if just for a moment. I also want to spread knowledge” about eating disorders.

She hopes everyone will print out and spread these cards around, and learn more about eating disorders. Her website is: You Are Not Your Body.


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January 28, 2008

Children hungry to lose weight

A diet program to reduce childhood obesity among school children in Scotland was given an interesting name: Hungry for Success. According to NHS Health Scotland, the program has been a “substantial” success ... except it failed to work.

Graham Donaldson, senior chief inspector for Her Majesty's Inspectorate of Education (HMIE), said in the latest progress report issued last week, that Hungry for Success has been successful in meeting many of its goals to encourage school children to eat ‘healthy’ and increase their fruits and vegetables. “There have been notable improvements in the quality of school meals in Scotland...accompanied by greater encouragement and opportunity to eat healthily,” he said. “However, that the period of successful implementation of Hungry for Success has been paralleled by increasing levels of childhood obesity and inactivity.”

According to the news, the Inspectorate’s report recommended intensifying the program for greater diligence, increasing physical activity, and consider testing “lunch-time lock-ins” to prevent secondary school pupils from leaving the campus for lunch.


Background

Hungry for Success was part of the comprehensive Scottish Diet Action Plan to get everyone in Scotland to eat healthier and reduce “overweight/obesity” and related diseases. If anything was going to reduce obesity rates across the Scottish population, based on popular wisdoms, this vast government initiative would do the trick.

In July 1996, Eating for Health: A Diet Action Plan for Scotland, (known as the Scottish Diet Action Plan) was published by the Scottish government. It served as the “blueprint for action” for the next decade of governmental health policy to “result in better health for all.” Its recommendations encompassed every facet of society, including 71 actions across nine sectors. The Scottish Diet Action Plan “aimed to shape consumer tastes, increase consumer demand for healthier food; supply food for a healthier diet through changes in the supply chain; help people understand healthy eating better through training, labelling and better public sector catering and to influence those who govern and monitor changes in health.” Its “target of greatest importance” was to increase consumption of fruits and vegetables and complex carbohydrates.

This massive initiative included every popular healthy eating idea that’s probably ever been proposed, such as: nutritional advice was given to every household in Scotland; public health education campaigns ensued, cooking shows and resources were devoted to ‘healthy’ eating; expectant mothers were intensely targeted for education to breastfeed and improve infant and children’s diets; “sustainable agriculture” was employed ”to get more local produce eaten by local people;” farm shops and farmers markets grew; food labeling was expanded to increase proper choices; food producers reduced sugars, fats and salts in food products to comply with new healthier nutrient standards; dairy fats were discouraged and fish oils encouraged; supermarkets were employed to bring healthy food to low-income communities; livestock was bred to be leaner, and even sugar was to be removed from children’s medicines.

Hungry for Success, geared to school children, had “enormous public and political support” and was well-funded, with $126.09 million (US dollars) committed to its first three years and more for the next three.

As part of Hungry for Success, “whole school approaches” to healthy eating were undertaken and health education was heightened throughout school curriculums to “raise dietary awareness in schools.” All staff involved in health education were provided special training in nutrition and diet. Nutrition standards and diet policies were established for school meals and were monitored. According to the HMIE inspectors' report published by NHS Health Scotland, the Hungry for Success program succeeded well beyond the original recommendations and even ended the sale of sweets and fizzy drinks in school meal halls. They found “substantial” improvements had been made in food choices and food service throughout Scotland. School meal standards were restricted even more per expert recommendations in 2003, and primary schools were to have these fully implemented by 2004 and secondary schools in 2006, and the inspectors reported success in meeting these goals. All schools had become “health promoting” schools.

Hungry for Success also introduced a course on cooking for all secondary pupils nationally, established in the late 1990s. Other Hungry for Success initiatives that saw “substantial success” according to the inspectors included ensuring that all “tuck shops” and school vending machines “reinforced the health promotion and health education messages of the school,” which were monitored as part of school inspections. Primary children were provided free fruit (100% of pupils by 2005). Low income children were given free breakfasts and eligible for other healthy eating initiatives to provide free produce with meals.

To sum up, healthy eating to prevent childhood obesity has been made the focus in schools since 1999. So, how did it succeed?


Results

Its first target goal — increasing fruit and vegetable consumption in kids — proved a failure. Despite years of nonstop messaging and even giving children free fruit in school, the report concluded “there is no evidence as yet that it directly impacts the total fruit consumption of primary school children.” Remember the similar program — called the School Fruit and Vegetable Scheme — undertaken to distribute free produce to more than 2 million children in 18,000 British schools? It was designed to create lifelong healthy eating habits in the pupils and cost $284.24 million just during its first two years. The program failed to increase the long-term fruit and vegetable intake in the children.

And, [this will be of no surprise to JFS readers who understand the causes for the diversities of sizes among children] Hungry for Success also failed to have any impact in achieving its primary goal: reducing rates of “overweight and obesity” in children. Hence, those calls in the opening of this article for stepped up intensity of interventions. The HMIE inspectors lamented that Scotland “faces rapidly rising childhood obesity.” They said that these figures from Scottish NHS National Services “led to widespread concern,” as they exceeded goals for the UK:

Does this look like a rapidly rising epidemic to you?

By reporting only the percentages of growing children crossing new arbitrary thresholds labeling them “overweight or obese,” it’s easy to create the illusion of a problem. But it doesn’t reveal the changes in actual heights and weights among children or give you the larger picture.

Researchers at the Department of Public Health, UMDS, St. Thomas’ Campus in London, tracked the growth of English and Scottish children from 1972 through 1994, recording the actual data for heights and weights measured each year among representative samplings of thousands of children, ages 5 - 10, as part of the National Study of Health and Growth study. They published their results in the Archives of Diseases in Children. For this discussion, we’ll look at the data for Scottish boys and girls.

From a health perspective, the actual figures gave every indication of good news for the general well-being of Scottish children. The most dramatic change seen over the decades was an increase in height, said the researchers. This indicated improved nutrition and health. The ten year old boys were an average of 3.13 cm taller and girls 2.73 cm taller than just two decades earlier [this growth in height was nearly twice that recorded among children in England]:

Weights “increased reasonably linearly,” the researchers reported. The ten year olds, for example, gained an average of 3.32 kg over those same decades. The Scottish children naturally added more weight than the English children, since they also grew significantly taller.

Looking at the increases in weights in boys and girls, they do follow reasonably close to the increases seen in height.

Weights increased slightly more than heights proportionally, but this also indicates healthier children. Plotting actual heights and weights on growth curves finds, for example, that in the early 1970s the weights of average Scottish ten year old girls were below the 50% percentile for weight compared to heights that were above the 50% percentile. They were disproportionally thin. By the 1990s, their heights and weights were more balanced, both averaging just above the 50% percentile. This would indicate that they were healthier, had better nutrition, and possibly higher levels of maturity. But even these changes, seen over decades, are not extreme or warrant concern. The actual differences in mean weight for height index, according to the researchers’ report, had actually increased by only 0.012.

So, at the time the Scottish government developed its massive Hungry for Success program to eradicate childhood obesity, there was no epidemic of childhood obesity. Nor was there any indication that children were horribly nourished. And in the years since, its own evidence shows it has not succeeded in changing that. No one had asked the right questions.

Dr. Peter March, co-director of the Social Issues Research Centre in Oxford, UK, analyzed the Health Survey for England data since 1995 and 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.” He 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.” You now also have decades of earlier figures to add for the full picture, and are probably wondering how an entire nation, like us, could become convinced of a crisis.

When growth of children is couched in terms of BMI, it is easy to forget this includes their height and is not just a measure of their weight. (Body mass index = weight in kilograms to the square of height in meters.) When using the percentages of children crossing arbitrary thresholds on growth charts by BMI, rather than small changes in actual weight and height, it is also easy to create a false sense of a tremendous epidemic of gargantuan children.

The facts are so inconvenient to agendas.


© 2008 Sandy Szwarc


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January 27, 2008

Not losing sight of the real issue on the latest cholesterol-lowering trial

Inquiries into the ENHANCE statin clinical trial controversy continue to escalate. Politicians and lawyers are getting on the bandwagon and following the U.S. House of Representatives Committee on Energy and Commerce and its Subcommittee on Oversight and Investigation, which began its investigation last fall. The biggest issues in all of this may slip away from us if we aren’t careful to recognize them.

Senator Chuck Grassley of the Committee on Finance began his own investigation on Thursday, sending letters to the drug companies Schering-Plough and Merck, the American Heart Association, and the American College of Cardiology similar to those also sent by the U.S. House of Representatives Committee. These lawmakers are wanting explanations for when the companies learned of the trial results (possibly prior to corporate officers selling off significant amounts of stock and the companies continuing to advertise claims the research didn’t support), but also want answers on industry funding of AHA and ACC, “nonprofit organizations which purport to be independent in their viewpoints and actions,” and continuing education of medical professionals. They are asking for all communications between the companies and these organizations regarding recent public statements made that echoed the companies’ reassurances, and they want full accountings on industry-supported continuing medical education “regarding cardiovascular risk management, and/or cholesterol control, and/or Vytorin.”

Senator Grassley’s letters to drug makers Schering-Plough and Merck, also raised concerns over what the delay in reporting the trial results may have cost Iowa residents and American consumers, stating:

While the health benefits of Vytorin appear similar to a cheaper generic, the cost difference to the citizens of Iowa is certainly another matter. At a Wal-Mart pharmacy in Iowa City, generic simvastatin costs $54.54 for a month’s supply while Vytorin costs $112.46. I am confident that the citizens of Iowa would have appreciated knowing that a cheaper drug works just as well. Instead, Iowans and other Americans paid out their hard-earned dollars unnecessarily for almost two years, while waiting for Schering-Plough and Merck to announce the scientific results of ENHANCE.

That isn’t the half of it, though. As Brandweek reported, even “the generic Zocor pricing is a scam.” It called for an investigation into how generics, which are supposed to save us all money, are priced. This generic drug, they pointed out, costs as little as $11.66 at Costco to $221.89 at Walgreens in New York. Wide price variations exist with other generic drugs, too.

“The best kept secret by the retail pharmaceutical industry is the obscene profits made on generic drugs by the large chain stores,” said Dr. Cyril Wolf, a prescription sales researcher. “Whereas brand name drugs are all purchased, and therefore sold, for around the same price, generics are obtained for a fraction of that cost. The price at which the generics are sold is determined by the sellers, who thus have the ability to make exorbitant profits on these drugs.” These generics actually save customers “very, very little” money, said Dr. Wolf, as many generics aren’t sold at prices that much lower than brand names, but almost always above their true cost and most hurt people already having trouble affording medications.

But that isn’t the half of it, either. Drug prices at pharmacies is not the issue in a free market where customers can shop around for a better price. The bigger concern comes in, as JSF reported last September, when those who control the access (where we can purchase meds) and the costs of prescription medications are the same ones in control of our medical records, and manage the medical care we receive and the medications we must take in order to receive healthcare, health insurance or government benefits.

When these price mark-ups are not disclosed by insurer PBMs (pharmacy benefit managers), and insurers benefit from getting more of us onto medications they sell that make them the biggest profits, we need to be very concerned about the objectivity and the conflict of interest of their medical (“disease”) management. [See Generic formularies.]

How much more are we spending for medications due to excessive mark-ups, but also for medications that may not provide the clinical benefits they purport?

Amidst all of the congressional hearings and media notice, and amidst the recent infestation of shark lawyers filing class-action lawsuits across the country over alleged cover-ups of the ENHANCE trial results, we mustn’t lose sight of the far greater issue in all of this:

The integrity of the scientific process ... in how drugs are researched and approved, and clinical guidelines are developed.

JFS began covering the ENHANCE clinical trial issue last November. This trial provided an opportunity to examine the importance of randomized controlled clinical trials, the gold standards of evidence-based medicine. Sound trial designs that are fair tests include randomization; double-blinding; a placebo control group; control of study data and analysis of study data by bodies independent from drug company sponsors; and primary endpoints that are actual clinical outcomes, such as reduced premature deaths, versus false surrogate endpoints.

On January 17th, “How’d we get here?” described the foundations of clinical trial evidence for drugs approved by the FDA that have been abandoned, and called into question the use of surrogate measures, like cholesterol, as proxies for actual clinical benefits to lives. When surrogate endpoints are used in order to expedite R & D for new drugs, post-market clinical trials are supposed to follow to provide the FDA evidence that these markers are valid and that the drugs actually save lives. But those studies never seem to come.

Senator Grassley seems to have taken up this issue. According to KaiserNetwork Daily Reports, on Friday, Senator Grassley said that “in light of what’s happened with Avandia and Vytorin, maybe the FDA needs to examine when it’s appropriate to use surrogate endpoints.” The FDA had approved Vytorin and Avandia because of their effects on health risk factors, LDL-cholesterol and blood sugars, widely believed to be markers for clinical outcomes. But, as research has been showing more than 30 years, since the Framingham study, the traditional cardiac risk factors are proving poor predictors of those who get heart attacks, and most people who suffer heart attacks don’t have high LDL-cholesterol or the other popularized risk factors.

Perhaps this hubbub will lead everyone to question their own assumptions and fears about health risk factors and to look closely at the evidence on cholesterol lowering for prevention of heart disease and whether it extends lives. According to Dr. Malcomb Kendrick, M.D., who has researched cholesterol for years and authored The Great Cholesterol Con, it is biologically implausible for LDL-cholesterol to cause atherosclerosis. “High cholesterol levels do not cause heart disease and the benefits of statins have been hyped beyond belief,” he said.

Dear Doctor

There have been lighter notes this week, as doctors express their skepticism of lowering LDL-cholesterol as a key in preventing heart disease.

Dr. Matthew Mintz, an Associate Professor of Medicine at The George Washington University School of Medicine wrote an entertaining commentary about a letter that had been sent out to prescribing physicians from Merck/Schering-Plough. His article, “Dear Doctor,” responded to five points in the letter.

I might add one more point to think about, taken from Schering-Plough’s News Release issued on Friday. The press statement seemed to downplay the significance of the ENHANCE trial results by emphasizing that the trial “involved 720 patients with a rare form of inherited high cholesterol known as Heterozygous Familial Hypercholesterolemia that affects less than 0.2 percent of the population.”

If this medication is being tested on people with such a rare disorder, and hence appropriate for these rare situations, why is it being marketed to practically the entire adult population?

As Dr. Elena Citkowitz, M.D., Ph.D., FACP, Associate Clinical Professor of Medicine, Yale University School of Medicine and director of the Cardiac Rehabilitation and Cholesterol Management Center at the Hospital of St. Raphael in New Haven, CT explained: “Familial hypercholesterolemia is an autosomal dominant disorder that causes severe elevations in total cholesterol and low-density lipoprotein cholesterol.” It is not simply “high cholesterol.” These are extreme cases, where people are born with a defective LDL receptor gene. Also known as heterozygous familial hypercholesterolemia, it occurs in about 1 in 500 people worldwide, with the homozygous form even rarer, at about 1 in a million. The cholesterol levels in babies and children with heterozygous FH are at least twice normal — 350 to 500 mg/dl — and in the homozygous form with no functioning LDL receptors, cholesterol levels are 700 to 1,000 mg/dl.

Does this describe your cholesterol level?

Or is this another case of extreme health indice levels associated with a health problem — levels multiple times normal or off the charts — being used to scare us that the moderate ranges normal in most people pose similar dangers? Have “high” risk levels been magically redefined to include levels that are far less significant? Is there evidence that a treatment for these rare and extreme conditions make it is a necessary and effective preventative for everyone else?

Only science that applies a rigorous and fair test can determine the answers. Only quality, randomized controlled clinical trial evidence, independently conducted and evaluated, can help to ensure we are making informed decisions that are based on evidence rather than beliefs, tradition and authority.


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Generic formularies

It is not hard to understand why a major health insurer would pay doctors by how well they comply with medication prescribing guidelines, why it would pay doctors to switch patients to certain generic prescription medications (such as for cholesterol-lowering), and why it would team up with an electronic prescribing service to monitor physicians and ‘alert them’ to patients that should be enrolled into the company’s disease management program.

It’s not hard at all.

Three recent examples in the news and medical journals remind us to think of insurers and pharmaceuticals in the same breath. There are enormous profits on prescription drugs possible through pharmacy benefit management (PBM) companies and most major insurers own their own PBMs. As John Richardson with Health Strategies Consultancy, LLC, explained at FTC hearings on June 26, 2003, PBMs contract with managed care organizations, self-insured employers, insurance companies, Medicaid and Medicare managed care plans, the Federal Employees Health Benefits Program and other government entities to provide managed prescription drug benefits. “PBMs manage about 70% of the more than 3 billion prescriptions dispensed in the U.S. each year... [and] manage pharmacy benefits for nearly 200 million Americans, including 65% of the country’s seniors.”

The more prescriptions written, the greater the profits for PBMs, i.e. most of our insurers. Not that honest profits are a bad thing at all. The troubling aspects come when conflicts of interests enter into the picture:

· When these same insurers also have electronic databases with all of our medical records, lab results and prescription records

· When these insurers tie reimbursements made to our doctors to how well they comply with performance measures, screenings and prescribing practices the insurer decides

· When these insurers determine our premiums, or even ability to get insurance, by how well we comply with their health assessments and managed care — guidelines the insurer helped to create. And in order for most adults to meet the ever lower recommended health indices, means prescriptions.

The more prescriptions written, the greater the profits. As professors at Creighton University School of Pharmacy and Health Professions explained in a recent issue of U.S. Pharmacy Review, the profit point spread insurers make on each prescription written adds up to unfathomable amounts. And insurers, through drug formularies that tier drugs to member co-pays, steer utilization of pharmaceuticals to those with greater proven effectiveness and safety, but cost factors are undeniable. Even before health risk assessments and insurer disease management programs became widespread, the Creighton researchers estimated the typical plan could generate about 100,000 prescriptions a year per 6,000 covered members. Applying their most conservative mark-ups to Blue Cross Blue Shield Association, with a database on 79 million enrollees, for instance, translated to potential PBM profits for BCBS plans alone of about $4.74 billion a year, plus about $2.8 million in administration fees.


e-Rx

Friday, BCBS of Massachusetts announced a new partnership with Zix Corporation. Their pilot project will use Zix’ electronic prescribing service (eRx) to monitor patients and identify those ‘eligible’ for the insurer’s disease management program. BCBS has created the country’s largest electronic prescribing network and said they believe it “can be leveraged to provide additional value to the prescribers, further increase patient safety and reduce overall healthcare costs to payers, physicians and patients.”


Generic rewards

Generics typically offer the lowest costs and greatest mark-ups for PBMs. Insurance plans that offer financial incentives to entice doctors to prescribe certain medications, primarily generics said to save money, have drawn scrutiny, according to this week’s Wall Street Journal. Concerns have been raised about these financial kickbacks, that are unknown to patients, entering into doctors’ medical decisions. Blue Cross Blue Shield of Michigan, for instance, launched a three-month program, called Blue Reward$, which rewarded primary-care physicians $100 for every plan member they switched from a brand-name drug to a generic cholesterol-lowering statin. The insurer provided each doctor with a list of every patient in the network who were taking brand name statins, Lipitor and Lescol. This initiative, according to BCBS, was to take advantage of the generic Zocor, as in the ENHANCE trial. BCBS said it spent $2 million in payments to doctors, and saved the insurance company $5 million in drug costs and plan members $1 million in co-payments. That sounds truly good, but it did not report how much the insurer made off of the sales of the generics.

Other insurers make generic prescriptions part of the doctors’ pay-for-performance (P4P) measures, which typically reward doctors 2% to 8% more in reimbursements if they meet certain criteria, such as prescribe more drugs electronically and reduce cholesterol levels in their patients. Blue Cross Blue Shield of Massachusetts, for example, gives doctors a bonus of up to $4 per patient a month for meeting a list of goals that includes higher generic prescription rates.


P4P incentivization

A six-year study published in last month’s issue of Health Services Research examined the effectiveness of the P4P program of BCBS of Hawaii — the largest provider of health care coverage in Hawaii, ensuring about half the state’s population — in changing doctors’ practices. In 1998, it had launched a doctor incentive program among their PPO providers, giving them bonuses based on the doctors’ meeting certain P4P measures that included clinical metrics measurable on claims data, their use of electronic medical records, and complying with medical and drug utilization measures. Among the Quality Indicators was compliance with prescribing lipid lowering drugs for adult members with ‘high’ cholesterol.

Doctors who participated in the voluntary program were given a direct financial award calculated by ranking each practitioner’s overall score to other participating doctors. The monetary rewards ranged from 1 to 5 percent of their base professionals fees in 1998-200, and increased to 7.5 percent in 2002-2003.

The study authors noted that P4P measures didn’t consider the severity of illness or the individual preferences of patients when they evaluated the doctors. In other words, doctors caring for older or sicker patient populations, or for ‘noncompliant’ patients, would be rated poorer by the insurer, giving doctors increasingly fewer incentives for caring for these patients. “Patient compliance is an important factor in the measurement of physician quality,” said the health plan.

By 2003, fewer than one-quarter of all physicians had chosen to not participate in the Hawaii incentive program. But the compliance results on the eleven P4P measures were mixed. They found only an untenable 6% increased odds ratio of patients who were seeing doctors in the P4P program receiving the healthplan’s recommended interventions, compared to patients seeing nonparticipating doctors. In fact, among patients seeing doctors who were both participating and not participating in the healthplan’s P4P program, the likelihood of them getting the healthplan’s recommended care dropped by 6% during the study years.

The study found that older, male patient members were less likely to meet the healthplan’s clinical measures to ensure rewards for their providers. And doctors who had “higher performance” before participating in the program (patient acuities were not reported) “received a disproportional higher percentage of the overall incentive budget,” indicating the program didn’t appreciably change doctors’ practices. The average participating physicians brought in $2,428 to $4,785 over the 6-year period.

The concept of P4P measures is growing in popularity among health insurers despite the problematic evidence, however, because of its potential for increasing provider compliance with recommended performance indicators, the authors wrote. They noted that single-payer or managed care plans that don’t give patients the freedom to see providers outside the network are more likely to have success in increasing adherence to guidelines. That’s because of mandatory participation of members in disease management, monitoring of members, and members are more likely to be subjected to “systematic interventions to improve care processes and outcomes.” They concluded: “Notwithstanding the limitations of evaluating the effects of a quality-based incentive program in a real-world setting, it is important to recognize the wide dissemination and interest for this new breed of physician reimbursement models by some of the leading private and public payers in the United States.”

This has real-world significance for consumers and healthcare providers who want to make medical decisions based on what is best for individuals, not just best for insurers.


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January 26, 2008

National medical welfare

This story needs no introduction, but does deserve thoughtful consideration.

Don’t treat the old and unhealthy, say doctors

Doctors are calling for NHS treatment to be withheld from patients who are too old or who lead unhealthy lives. Smokers, heavy drinkers, the obese and the elderly should be barred from receiving some operations, according to doctors, with most saying the health service cannot afford to provide free care to everyone....

The findings of a survey conducted by Doctor magazine sparked a fierce row last night, with the British Medical Association and campaign groups describing the recommendations from family and hospital doctors as “outrageous" and “disgraceful"...


One in three said that elderly patients should not be given free treatment if it were unlikely to do them good for long. Half thought that smokers should be denied a heart bypass, while a quarter believed that the obese should be denied hip replacements...

Gordon Brown promised this month that a new NHS constitution would set out people's “responsibilities" as well as their rights, a move interpreted as meaning restrictions on patients who bring health problems on themselves. [A belief founded on pseudoscience that the natural diversity of sizes, health problems and aging are determined by compliance with ‘responsible’ or ‘good’ behavior.]

The survey found that medical professionals wanted to go much further in denying care to patients who do not look after their bodies.

Katherine Murphy, from the Patients' Association, said it would be wrong to deny treatment because of a “lifestyle" factor. “The decision taken by the doctor has to be the best clinical one, and it has to be taken individually. It is morally wrong to deny care on any other grounds," she said. Tony Calland, chairman of the BMA's ethics committee, said it would be “outrageous" to limit care on age grounds... "it's not our job to play God."


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Reading for thought


Inspired by George Santayana

What happens when a nation embraces the idea that people bring health problems on themselves through undesirable behaviors, that the common good is greater than that of the individual, and that government determines what is best for all? When government health and medical policies are based on the inherent worth of individuals, can those who are seen as more costly or less productive be cast aside? Mark P. Mostert, Ph.D., of Regent University, examined the history of medical and healthcare policies in Germany during the early 1900s, in an article for the Journal of Special Education:

Useless Eaters: Disability as Genocidal Marker in Nazi Germany

Societal tensions generated by deprivation, war, and notions of peoples’ relative worth based on their ability to contribute to society continued to affect people with disabilities in institutions across Germany until the late 1920s, precipitating rapid and radical attitudinal changes even as the medical and psychiatric communities continued to struggle with custodial issues related to asylum inmates. It was clear, however, that extensive and expensive care could not be expended on people who could not immediately aid Germany’s economic recovery... two perceptions were firmly fixed among German medical professionals and laypeople alike.

Those individuals viewed as economic burdens were increasingly seen as threats to society and their behaviors increasingly perceived as undesirable. The slippery slope had begun:

The distinction between voluntary euthanasia and involuntary killing was thus effectively eradicated, and an ominous term was coined for the first time: “life unworthy of life.” In 1920 the concept of living beings not worthy of the life they embodied gained impetus with a tract published by two university professors, Karl Binding and Alfred Hoche. Permission for the Destruction of Life Unworthy of Life articulated key implications for people with disabilities. Binding and Hoche called for the killing of people with disabilities... the imposition of others’ will upon them. This shifted the burden of human existence from simply being alive to requiring an explicit justification for living... the right to live was to be earned, not assumed. One earned the right to live by being a useful economic contributor to society....

Chief among the individuals they saw as being useless...whose only societal function was the consuming of precious resources while contributing nothing to society in return. In Binding and Hoche’s terms, they were “useless eaters” whose “ballast lives” could be tossed overboard to better balance the economic ship of state. Furthermore, Binding and Hoche drove home the economic argument by calculating the total cost expended in caring for such people. They concluded that this cost was “a massive capital in the form of foodstuffs, clothing and heating, which is being subtracted from the national product for entirely unproductive purposes.”

His depictions of differences among people have a similarity with current discussions surrounding the ‘obese:’

Social Darwinism, which held that in humans, both biological and social traits were passed from one generation to the next. Thus, as scientists busied themselves with measurement, classification, and definitions based on physical, biological, and social similarity and difference, they not only reinforced popular social prejudices but enshrined them as irrefutable scientific fact. By the early 20th century, scientists had amassed a great deal of pseudodata portending to show differences between individuals, genders, and ethnic groups by rank ordering any population trait from superior to inferior.

Having established the concept of social heritability and its consequences for individual inequality, similar rankings of desirability were soon applied to entire groups of people, including grouping people by class. That is, the more “inferior” (i.e., lower class) the person, the more likely they would be to engage in undesirable social behavior and often criminal behavior... By 1938 the tide of public and official benevolence toward people with disabilities had begun to turn. The public mind now characterized people with disabilities as a separate, different, often criminalized group of less economic value than their counterparts without disabilities. German literature and art soon depicted lives unworthy of living in a host of propagandistic projects....

This indepth historical examines the evolution of a political and social mindset that allowed medical professionals, science, and society to do the unthinkable. The year 1939 was designated by the Nazis as the year of “the duty to be healthy.” Its historical accounting of how the lives of children and elderly were decided is chilling. Professionals can use this historical touchstone when examining perceptions of discriminated peoples, “including the role of science, the power of ideas, the convergence of macrosocietal conditions, the complicity of the medical profession, and the role of propaganda.”

A major impetus for what followed, he explained, was the claim of legitimacy based on pseudoscience, “which drove perceptions of difference from benign recognition to active genocide:”

Not only was the pseudoscientific claimed as science (i.e., as established fact, data based, and replicated over time), but it was used as an instrument of deceit... In the marketplace of ideas, eugenics was embraced largely because it served a wider prejudicial purpose, namely, to control and then rid Germany of people deemed different, inferior, and asocial. The minority who resisted were soon silenced in the tidal wave of a demand for conformity...

Currently, there is evidence of the medical community’s again being willing agents in hastening the deaths of people deemed not viable... Once again, patients, including those with disabilities who are terminally ill, now bear the responsibility of justifying their existence and their need for treatment. This being the case, and with the clear understanding that not all physicians put the greater good ahead of their individual patients, there should at least be some debate about what this means for people with disabilities, many of whom rely extensively on the assumption that their physicians have their best individual treatment interests at heart and will treat them regardless of utilitarian arguments to the contrary.

The full article here.


Poster translation: "This genetically ill person will cost our people's community 60,000 marks over his lifetime. Citizens, that is your money. Read Neues Volk, the monthly of the racial policy office of the NSDAP." [1930s Nazi poster]


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January 25, 2008

Fishy sushi scares

We now have a national newspaper create a news story, then report it as news, incorrectly — and, incredibly, that is considered professional journalism.

New York Times bought tuna from twenty stores and select restaurants and had them all tested for mercury levels. What did it find?

All of the tuna it tested being sold commercially in New York had mercury levels nearly ten times below the lowest amount that has been shown might ever pose a danger to the most sensitive population (babies and children) with a lifetime of daily exposure.

Good news, reassuring news, helpful news. There is no evidence of anything to fear.

But that was not what the paper’s health reporter or editors reported this week. Instead, the paper put a different spin on the findings. In a story quoting well-known mercury activists, it headlined its sushi series with “High Mercury Levels Are Found in Tuna Sushi.”

The newspaper had samples of tuna tested by Dr. Michael Gochfeld of the environmental and occupational medicine department at Robert Wood Johnson Medical School, who also treats patients with mercury poisoning and is the former chair of the NJ Mercury Task Force. According to the paper, they found “so much mercury [in most of the samples] that a regular diet of six pieces a week would exceed the levels considered acceptable by the Environmental Protection Agency.”

The NY Times failed to mention what it meant by “high,” or put the science into factual context for readers. Even the highest mercury levels the Times found were far below what the FDA or EPA have identified as a level where potential health risk might begin: called the benchmark dose.

The benchmark dose is the lowest dose considered safe from any effect over a lifetime of daily exposure in the most sensitive population of children, explained Dr. Joseph Jacobson, of Wayne State University and a member of the National Academy of Sciences’ Committee on Methylmercury.

The FDA and EPA then add an arbitrary ten-fold safety cushion to that, to arrive at a “reference dose” — that’s the 1 part per million which the FDA uses for regulatory reporting (called its “Action Level”). That safety cushion is not a threshold where any possible risk begins; but that's what the Times incorrectly reported and used for its definition of "high."

The EPA does not determine or regulate safe levels of mercury in commercial seafood for human consumption, the FDA does. The EPA issues environmental fishing advisories for the small portion of recreational fishing. To minimize consumer confusion, however, they did jointly issue fish consumption advisories.

The Times found mercury levels in the tuna samples of 0.1 to 1.4 parts per million — all far below any potential risk. The levels were a tiny fraction within the regulatory safety cushion. And the results were not surprising. The FDA, which tests methylmercury levels in commercially-sold seafood, has found similar ranges and found that the 25 most popularly-eaten fish average methylmercury levels of 0.12 ppm.

The Times proceeded to warn of the risks for women who might become pregnant and children. It failed to mention that according to the U.S. Centers for Disease Control and Prevention’s National Health and Nutrition Examination Survey (NHANES), not a single woman of childbearing age or child in the United States has mercury levels anywhere close to unsafe levels.

In fact, it’s impossible for American women to eat enough fish to put their newborns at risk, according to the U.S. Department of Agriculture’s Human Nutrition Information Services. It analyzed the diets of American women of childbearing years using several available dietary surveys and factored in endless possibilities — such as heavy fish consumption, eating fish varieties with the highest methylmercury levels, repeatedly eating the same fish, and the amounts of methylmercury in a range of commercial fish samples. After 100,000 iterations, they found it was inconceivable for a mother to eat so much purchased fish she’d put her baby anywhere near harm’s way. Dr. James Heimbach, former associate administrator with the HNIS, reported at the FDA Methylmercury scientific meetings that American women “simply are not exposed to levels of methylmercury that would place the newborn children at risk.”

The Times also failed to mention any of the research of the world’s foremost experts on methylmercury and health — even though it has been widely reported and internationally recognized. For more than 30 years, researchers at the University of Rochester Medical Center, in Rochester, New York, have closely followed populations eating large amounts of fish, including Samoans, Peruvians and residents of the Seychelles, and found no associated adverse effects in adults or children. The most careful and exhaustive, double-blind, longitudinal methylmercury exposure study ever conducted on expectant mothers and children was done on the people of Seychelles. These people have the highest per capita consumption of fish in the world, typically 12 fish meals each week, the same types of fish Americans eat. Even though the Seychelles children get 10 to 20 times more methylmercury than U.S. children, the researchers have tested them for more than 14 years now (using multiple global tests and over 57 endpoints for neurocognitive, language, memory, motor, perceptual-motor, and behavioral functions) and found no detectable adverse effects.

As the FDA’s scientific experts concluded after reviewing the evidence, even among populations eating many times more fish than Americans eat, scientists have found no credible evidence of neurotoxicity, or anything remotely resembling brain damage, retardation or learning disabilities or other health concerns.

In fact, there has never been a case of an American eating so much fish as to be harmful. The only cases in the scientific literature of mercury poisoning from fish and subsequent neurological problems — a fact confirmed by Dr. Thomas Clarkson, a toxicologist at the University of Rochester School of Medicine — were the result of an industrial mercury spill in Minamata Bay, Japan in the 1950s, which resulted in fish with methylmercury levels 40 to 1,000 times higher than the fish Americans, and most people around the globe, eat. These tragic poisonings first pointed out that at extremely high exposures, mercury was a neurotoxin and might affect the developing fetus.

But poisonings from a rare toxic spill is much different from the amounts of methylmercury that have always naturally been in fish and in human bodies. Methylmercury — an organic compound produced by methane-generating bacteria deep in bodies of water as they ingest inorganic mercury — is nothing new. And despite all of the recent scares, the amounts we’re exposed to have been dropping for centuries. While a physiological basis for the neurodevelopmental effects of toxic levels from mercury poisoning is understandable, there is no biological basis why our natural, low-level exposures would pose any risks, according to Dr. Gary J. Myers, M.D., another methylmercury expert at the University of Rochester Medical Center.

The Times published an accompanying piece describing the findings of Dr. Jane Hightower in San Francisco, whose controversial work has been with women complaining of vague symptoms of fatigue, thinning hair, aches and trouble concentrating and who believe they are being poisoned. She tested their hair or blood and found some with those same “high” levels. After eliminating fish from their diet, the women — described as “high end consumers” — said their symptoms went away. [Evidence not of the effects of mercury, but of nocebo and placebo.]

But the Times failed to mention the conflicts of interests of the people quoted in their story, all of whom were with environmental groups lobbying against mercury, as the National Fisheries Institute noted. In a public statement about the Time’s “poorly-sourced sensational article,” it said it “presents a distorted report on sushi and seafood that is at odds with widely accepted science.”

One of the restaurants that the Times singled out for having “high” mercury levels was Nobu, owned by Drew Nieporent and Robert De Niro, and considered one of the finest Japanese restaurants in New York. Chef Nobu Matsuhisa’s creations are considered works of art and widely praised by celebrities from Madonna, Giorgio Armani, Bill Clinton, Andrea Agassi, Robin Williams, Cindy Crawford, Leonardo DiCaprio to Kate Winslet, who described them so good they are “quite simply heaven on earth and sex on a plate.” The Times failed to mention that Nobu has been in the crosshairs of environmental groups for selling seafood these groups oppose. Or was Nobu’s mention not a coincidence, either?

In the end, however, the Times series has been largely ignored by the media and it has not been widely disseminated by reputable publications and news outlets, much to their credit.

Even the largest consumers of tuna in the world — the Japanese, who consumed 610,000 tons just in 2004 — were unimpressed by the Times stories. Coming from the site of those tragic poisonings during the 1950s, these residents understand that real toxicology risks come in the dose. The Japanese government doesn’t consider these levels, that occur naturally in nearly all fish, to be a health concern and doesn’t set limits on mercury content in tuna. Teruo Tagaki, chief of the product safety office of Japan’s Fisheries Agency, said that “the newspaper is exaggerating the risk.” He told Bloomberg in Tokyo about the 2005 study by Japan’s Food Safety Commission that found ingesting as much as 100 micrograms of mercury each week presented no risk to health for a person weighing 50 kilograms.

It appears some Times readers bought this week’s hoax, however, with truly worried comments on their forums. A few television stations and newspapers also picked up the Times mercury story, even embellishing it further by claiming the FDA was behind it and was going to take legal action to ban tuna sushi, and that the levels found were what “the FDA considers so high that the food is legally adulterated.”

Did the Times actually believe readers would buy their made-up news scare? Or did they believe it themselves? It is difficult to imagine that national-scale professional journalists don’t understand the basics of fact checking and balanced reporting, or the basics of sound science and health (like the dose makes the poison). Or was it all a perverse joke on readers? That’s what it appears reading a side piece that was clearly satire, with an imaginary debate with the presidential candidates.

Whatever their motives, making up a news story, needlessly scaring readers, and failing to give readers the full story is not professional journalism. Not even close.

So, if you paused before heading to your favorite sushi or seafood restaurant, or began to wonder what is safe to eat during Lent, it pays to remember to be skeptical of scary things in the news.

The only thing anyone need concern themselves with is proper - sushi bar - etiquette. And, how you can possibly taste all of the delicious sashimi there is to enjoy.


© 2008 Sandy Szwarc


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