Seeing the evidence: Tighter control of blood sugars in type 2 diabetics

Mainstream media paid little attention to this study, even though it provided a comprehensive look at the clinical trial evidence to date on whether keeping tighter control over blood sugars benefits people with type 2 diabetes. The facts could have extraordinary impact on support for population HbA1c surveillance programs with obligatory diabetes management that are being enacted by growing numbers of government health departments, health plans and employee wellness programs. It could also be important information for people with type 2 diabetes. But facts that few people hear about can’t help many people.

Researchers, led by Dr. Kausik K. Ray, M.D., with the Department of Public Health and Primary Care at Strangeways Research Laboratory in Worts Causeway, Cambridge, UK, noted that type 2 diabetes is widely seen as a risk factor for cardiovascular disease, and clinical management of the disease is focused on glycemic control in hopes of reducing cardiovascular and microvascular outcomes. Some have suggested that clinicians should aim for increasingly lower blood sugar levels, which has led to randomized controlled clinical trials trying to see if more intensive control of blood sugars can reduce long-term clinical events and lengthen lifetimes, compared to standard treatments. To date, however, “individually these trials have failed to show consistent beneficial effects on cardiovascular events,” they wrote.

Suggesting that, perhaps, these trials may have been too underpowered to show a clinical benefit, these researchers conducted a meta-analysis of randomized controlled clinical trials done between 1970 and 2009 that had studied the effect of tight blood sugar control on cardiovascular outcomes. The study was just published in The Lancet, but it deserves a closer look to distinguish what the data itself revealed from interpretations.

Methodology

The authors stated that their methodology was robust. They included only randomized, placebo-controlled trials that compared standard treatment to more intensive lowering of blood sugars, and which had cardiovascular events as their primary endpoint and reported measured clinical endpoints, including all-cause mortality. Their search to identify trials and obtain the needed clinical data was intense and included published and unpublished data, and they assessed the probability of publication bias with funnel plots and the Egger test.

They excluded six trials that failed to meet their criteria for fair tests, such as failing to use a placebo, failing to examine diabetics, or failing to report clinical endpoints. One study was excluded for not having cardiovascular events as its primary endpoint: the RECORD Study. This randomized controlled clinical trial on 4,447 type 2 diabetes patients had compared standard treatment to those receiving additional medications (rosiglitazone) for glycemic control. The interim analysis, cited by the Cambridge authors, reported that after nearly four years, there was no difference between the groups in deaths from any cause or from cardiovascular events. The rosiglitazone group also had more than a double risk for heart failure, compared to standard treatment.

The Cambridge authors also excluded trials conducted on hospitalized patients. The reasons for this may not be clear to the general public, but it is widely known among medical professionals that tighter blood sugar control among critically ill patients has never been shown to lower their mortality, the need for dialysis or mechanical ventilation, or the number of hospitalized days; but has even been shown to increase risks of dying and raise risks for serious hypoglycemia by up to 13-fold.

Last year, for example, the VA Outcomes Group had noted that recommendations for tight glucose control in critically ill patients are “based largely on one trial that shows decreased mortality in a surgical intensive care unit” but similar studies have not and are reporting that tight glucose control can cause dangerous hypoglycemia. They felt “the data underlying this recommendation should be critically evaluated.” They examined 29 randomized controlled trials involving 8,432 critically ill adult patients. Their results, published in the August 2008 issue of the Journal of the American Medical Association, found that tight glucose control was not associated with significant reduced mortality or need for dialysis, but with a five-fold higher risk of hypoglycemia.

A large international analysis of 26 randomized clinical trials on critically ill patients, just publishedCanadian Medical Association Journal, found no benefit in overall mortality with tighter blood sugar control, but it was associated with a six-fold increase in risks of severe hypoglycemia. last month in the

Doctors with Stamford Hospital, an adult ICU at a large university-affiliated hospital, examined about six years of patient records and found that a single episode of severe hypoglycemia was associated with more than doubled risk of dying among their critically ill patients.

The most recently reported randomized clinical intervention study was the large international NICE-SUGAR Study. In this study, 6,104 patients with type 2 diabetes admitted to intensive care units were randomized to receive either standard blood sugar control (with a blood sugar target of 180 mg/dl or less) or tighter control (81-108 mg/dl). Regardless of the different conditions among the critically-ill patients (medical or surgical), the 90-day mortality was higher among those whose blood sugars were more intensively controlled: 27.5% died compared to 24.9% receiving standard control. There was no difference between the groups in the number of days in the ICU or in the hospital, or those needing dialysis or mechanical ventilation. But life-threatening severe hypoglycemic episodes occurred in 6.8% of the intensive control group compared to only 0.5% in the standard care group.

In the end, five trials were included in the Cambridge authors’ meta-analysis, all varying greatly in the demographics of the participants, progression of their diabetes, duration of follow-up, and drugs used for intensive glucose control.

Findings

While mainstream media didn’t widely report Dr. Ray and colleagues’ study, industry trade publications for medical professionals did. They consistently reported the study as supporting intensive glucose control, all emphasizing that lowering mean A1c levels by nearly 1% had been shown to significantly reduce cardiovascular events.

The study authors, themselves, concluded: “Our quantitative analysis of randomised controlled trials provides reliable large-scale evidence of a consistent beneficial effect of intensive treatment on non-fatal myocardial infarction and coronary heart disease, without increased risk of all-cause mortality.”

The review articles reported the authors’ findings, for example, that the intensive medical and pharmacological blood glucose management was associated with a 15% lower risk for all coronary heart disease events, compared to standard treatment. The authors had calculated odds ratios, which makes risks seem more significant, while actual compiled incidences of coronary heart disease events were 6.8 percent in the intensive treatment group and 7.2 percent among the standard treatment groups, with a difference of a mere 0.4%. Absolute values aren’t headline material.

Heartwire said this study reinforces the recommendations of the American Diabetes Association, American Heart Association, and American College of Cardiology, to get diabetics’ HbA1c levels below 7.0%. No one drug is capable of doing that in the vast majority of patients, and the use of three or more drugs in combination is common. Dr. Ray told Heartwire, “what this study does is help those individuals out there with diabetes and their caregivers and lets them know that what they’ve been doing is likely safe and is justified.”

The full picture

But is that really what this study demonstrated? Did you catch the more important piece of the story — the one that patients care about?

If handfuls of drugs might lower your risk of dying from one thing, but raise your risks of dying from something else, that’s an important part of the story. Medical professionals care for the whole patient and the most important clinical endpoint is death. The more intensive drug regimens were not shown to improve lifespans. Overall deaths were slightly higher in the intensive treatment group compared to the standard treatment. It was an untenable 2% higher risk (0.8% higher actual incidences), but clearly this meta-analysis didn’t provide evidence to justify exposing patients to more drugs to lower a single health index, which comes with additional financial costs and concomitant side effects.

This paper didn’t examine what the causes of the higher deaths were among the patients receiving more intensive management or side effects that may have impacted the patients’ quality of life, although the authors did note that severe hypoglycemic episodes were doubled in the intensive treatment group.

In contrast to the industry coverage of this meta-analysis, an evidence-based perspective might more accurately have said: "The clinical trial evidence to date fails to show that tight glucose control offers significant benefits to patients."

Instead, medical professionals saw headlines focused on reduced nonfatal heart attacks and coronary heart disease events, leading most readers to come away thinking overall benefits had been shown.

In fact, the meta-analysis found greater risks of dying among those with the most intensive pharmacological management of blood sugars. The two trials (VADT and ACCORD) showing the highest risks for overall deaths were on patients with the more advanced diseases (10-12 years from first diagnosed compared to 8 years in all but one* of the other trials). The patients also had the highest HbA1c levels at the start of the trials (9.4 - 8.3% compared to 7.9 - 7.1% in the other trials), meaning they also required more medications to bring their HbA1c levels below 7%. More intensive pharmacological management and advanced disease was associated with greater risks of dying. The authors said they didn’t have sufficient data when calculating their odds ratios to control for confounding factors, such as age, gender, duration of diabetes, baseline HbA1c, and comorbidities. In other words, they couldn’t credibly conclude that tighter glucose control was behind the purported lower risks seen primarily in the type 2 diabetes whose disease was less advanced.

A second look

Did you see the controversial study included in their analysis? The trial that the authors showed with the most significant reduction in risks of dying (-21% odds ratio) associated with intensive glucose management to get HbA1c levels below 7% was the UKPDS Study (United Kingdom Prospective Diabetes Study). Without this trial, the reported risks of dying associated with tighter glycemic control would have been higher.

* This was also the one trial with newly diagnosed patients (<1 year from diagnosis) and with starting HbA1c levels of only 7.1%. These HbA1c levels were much lower than those seen in the VADT study participants (average 9.4%) and in the ACCORD patients (average 8.3%).

But the UKPDS Study had reported no statistically significant (p=0.44) reduction of all-cause mortality among the intensive blood sugar managed group compared to standard treatment. As covered here in “Are you sure about that?”, the evidence found in the UKPDS Study had contradicted the claims of benefits that were being reported by reviews in industry publications and written by experts in the medical community. The UKPDS data itself showed that early and intensive management was not associated with significant reduction in any adverse outcome. The trial showed no reduction in any macrovascular (large blood vessel) complication, such as cardiovascular events (heart attacks, heart failure, strokes or amputations), and no reduction in deaths.

As Dr. Kenneth G. Marshall, M.D., with the Department of Family Medicine at the University of Western Ontario, wrote in the Journal of the Canadian Medical Association, the UKPDS documented that intensive pharmacological treatment of type 2 diabetes did not lessen illness or reduce deaths from macrovascular causes. A sub analysis on ‘obese’ diabetics was widely reported has showing that the intensive therapy reduced cardiovascular disease in these patients, but few heard that it had no effect on microvascular or cardiovascular outcomes or that these patients had higher rates of death compared to obese controls receiving standard care (RR=1.60).

“The UKPDS reported a 25% reduction of microvascular [small blood vessel] disease with intensive treatment,” noted Dr. Marshall, but this was defined by using a surrogate outcome: progression of retinopathy as identified by ophthalmologic examination. The study was not blinded, lending further caution with such subjective assessments. The claim was not based on clinical endpoints related to microvascular disease, such as visual acuity or blindness. “No difference was seen in the more important clinical outcome of vision loss between patients treated intensively and those who received conventional treatment,” Dr. Marshall wrote.

Never the less, the UKPDS Study’s abstract concluded: “Intensive blood-glucose control by either sulphonylureas or insulin substantially decreases the risk of microvascular complications.” And this is the source of beliefs that tighter blood sugar control reduces the complications of the disease.

As a busy family GP of 17 years , I have many NIDDM patients and get to know them all quite well. I have looked at the actual evidence ie UKPDS to see if I can decide for myself how to advise the diabetic who is torturing themselves physically and psychologically to seek the supposed targets promoted in Diabetic Education Brochures. I have read UKPDS 33 over and over and over and am just astounded at the rampant interpretative bias…On a final cynical note I wonder how the BMJ/Lancet could have ever allowed the abstract for UKPDS33 to include the comment, "SUBSTANTIALLY reduces the risk of diabetic complications." It is the abstract that is quoted and requoted, and there is the origin of the mythology. — Dr. Paul C. Neeskens, “UKPDS—Emperors New Clothes,” British Medical Journal, September 11, 2003.

To this day, no sound clinical study has ever shown that treating type 2 diabetics to achieve even lower blood glucose levels provides added benefits that outweigh the harms. Treating a number that is a symptom of a disease doesn’t mean the disease process has been changed. Lowering health indices in elderly patients to match those of healthy 20 year olds doesn’t mean their risks will be lowered to those of 20-year olds again. And minimizing the risks associated with extremely high lab values doesn’t mean that “how low can you go” is better for patients.

Busy medical practitioners rely heavily on experts’ assessments of research findings, but those assessments are fraught with biases. As Dr. John P. Ioannidis, M.D., at the University of Ioannina School of Medicine in Ioannina, Greece, and with the Institute for Clinical Research and Health Policy Studies at Tufts-New England Medical Center, Tufts University School of Medicine in Boston, cautioned: “Empirical evidence on expert opinion shows that it is extremely unreliable.” As we also see time and again, the analyses and conclusions made by study authors and industry experts often differ from what the data actually shows. Bias doesn’t always come from financial conflicts, but can come simply from a belief in a popular scientific theory. It can lead even medical professionals to see only what supports a theory: confirmation bias.

Myths can take on lives of their own even in medicine unless we look objectively and carefully at the evidence. Only with unbiased discussions can we ever hope to turn evidence-based medicine into evidence-based medicine.

© 2009 Sandy Szwarc

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Weighing the risks of vaccinating children for whooping cough

Loving parents have a hard job. They want to protect their children from harm and make the best healthcare decisions for them, but with all of the health information and misinformation swirling around, it can seem impossible to know what to believe. One question for some parents is whether childhood immunizations are necessary anymore. With fewer children dying of childhood illnesses today, it can seem like the diseases are no longer serious and that the vaccines might be putting their children at needless risk.

Researchers, led by Dr. Jason Glanz, Ph.D., a senior scientist at Kaiser Permanente's Institute for Health Research, wanted to get parents the most accurate information possible on immunizations in order to help them make the best decisions for their children. They conducted a study, just published in the June issue of Pediatrics, looking at every case of pertussis infection identified in children in the Kaiser Permanente of Colorado health plan over more than a decade, between 1996 and 2007. They randomly matched each case to four controls and looked at the children’s vaccination records. The differences were striking. Only 0.5% of the healthy children had not been vaccinated, compared to 12% of the children who had gotten sick with pertussis.

That means, unvaccinated children are associated with a nearly 23-fold higher risk of getting the disease compared to vaccinated children. [Now this is a tenable correlation and real relative risk.] Deciding not to vaccinate children does not keep them safer from childhood diseases, but puts them at considerably greater risk.

Pertussis, commonly called whooping cough, is a highly contagious infection due to Bordetella pertussis. It is a serious respiratory infection that begins with cold symptoms that last a week or so, when people are the most contagious. Then, it progresses to the paroxysmal stage, which can last up to ten weeks. That’s characterized by intense attacks of severe coughing, around 15 episodes a day, that result in “whoop” sounds as the patient tries to gasp for breath between coughs. Babies and others can stop breathing and turn blue, and often vomit from coughing so hard.

The vast majority of pertussis cases (88.2%) are in children under ten years old. Before the vaccine was introduced in the 1940s, pertussis was a major cause of death among infants and children in the United States. It still is in many parts of the world. The World Health Organization reported more than 200,000 pertussis-related deaths in 2000. With our increasingly mobile society and people traveling around the world, the likelihood of children in our country being exposed to someone who is infected also increases.

Parents clearly cannot rely on other children in their local schools being vaccinated to offer sufficient “herd immunity” to eliminate the need for their own children to be vaccinated. But vaccinating isn’t only to protect their own child — it’s to help protect the most vulnerable children in the community, especially infants who are too young to be vaccinated.

Nearly all fatal cases of pertussis occur in infants under six months of age, who are too young to have been immunized, said pediatrician Dr. Hazel Guinto-Ocampo, M.D., with Nemours Children’s Clinic. Young infants this age are more likely to get sickest with pertussis, with 69% requiring hospitalization. They’re also more likely to develop complications that include pneumonia, which affects one in five babies, brain swelling encephalopathy and seizures in one percent, and failure to thrive. Among older children, teens and adults, the complications can include pneumonia, rib fractures, incontinence and exhaustion.

Preemies and young infants; and children with heart, lung or neurological health problems; are at special risk for contracting pertussis and developing complications. Young babies are at the greatest risk of dying, with 1.8% of babies under two months dying, according to the June 6, 2008 issue of the MMWR from the Centers for Disease Control and Prevention (CDC). Pertussis causes an estimated 10–20 deaths each year in the U.S., said the CDC.

Newborns most often get pertussis from being around adults and teens who don’t realize they have the disease. During the first weeks of the illness, symptoms can mimic a common cold or flu, but that’s also when people are the most contagious. That’s why medical professionals are stressing the importance of the DTaP booster shot, which was introduced in 2005, for teens and adults whose immunities wear off. Its importance was learned during the 1980s and 1990s, when reported cases of pertussis increased, most notably among teens and adults, and pertussis-related deaths among babies rose — rising from 61 to 93 deaths between 1980-89 and 1990-99.

Pertussis vaccines are more than 90% effective and after their introduction, pertussis cases dropped to the lowest rates in U.S. history by 1976, according to the CDC. Because of vaccinations, reported cases of pertussis are 50-fold less than they were during the prevaccine era. Childhood vaccinations are one of the safest and most proven measures parents can take to protect their children.

There are so many claims out there trying to scare parents about vaccines, but they are not grounded in any good science. “Vaccines are among the most tested drugs we have,” said Dr. Lance Chilton, M.D., professor of pediatrics at the University of New Mexico and co-chair of the Clinical Prevention Initiative Immunization group. Sure, there are lots of unsupportable preventive public health claims out there, but basic childhood immunizations are not among them. The risks of not vaccinating children are so much greater than the risks of the vaccine.

With this latest study, parents now have information on just how significant those risks can be.

For more information on pertussis and the DTaP vaccine:

Pertussis — Centers for Disease Control and Prevention

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Pills with consequences

The media has widely covered the Hydroxycut recalls issued by the FDA earlier this month, making it unnecessary to repeat the recall notices here in detail. JFS readers aren’t the customers for dietary supplements marketed as being for weight loss, as fat burners, as energy-enhancers, and as low-carb diet aids. But one aspect of the news story hasn’t caught the attention of media and may provide a helpful cautionary note for readers.

Background

On May 1st, the FDA issued a consumer release, warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, New York. After receiving 23 reports of serious health problems, including liver damage resulting even in the need for a liver transplant and one death from liver failure, associated with use of the dietary supplements, the FDA announced that Iovate had agreed to recall all of its Hydroxycut products, except for Hydroxycut Cleanse and Hoodia products. The FDA’s Hydroxycut website provides a list of the recalled products, the warning letter issued to Iovate, and updates.

In 2002, the FDA’s Center for Food Safety and Applied Nutrition’s adverse event monitoring system, CAERS, began receiving reports of liver-related problems in people also taking the dietary supplements. Some people have experienced liver complications after taking the supplement only a week. As MedWatch — FDA’s Safety Information and Adverse Event Reporting Program — noted, however, the agency hasn’t yet figured out which ingredients, doses or health-related factors may be associated with the problems being reported with Hydroxycut products. The FDA’s Health Hazard Evaluation (HHE) board noted that the products contain a wide variety of ingredients, including proprietary mixtures, making it hard to isolate the ingredient(s) that might be contributing to health problems.

The FDA’s job is made especially challenging because products sold as dietary supplements don’t have to be registered with the FDA or undergo safety evaluations before they can be sold; nor can the FDA validate a manufacturer’s claims or test supplements to make sure they contain what the labels say, are not contaminated and are safe. With the Dietary Supplement Health and Education Act (DSHEA) of 1994, it can only act to protect consumers after a product is already on the market and the FDA proves the product is unsafe or is putting consumers at undue risk. It has only voluntary adverse event reports, which are understandably incomplete, and other sources of information, such as the medical literature, to rely upon.

The labels on Hydroxycut products say they contain minerals and herbs, as well as extracts Garcinia cambogia, Guarana, gymnema sylvestre, Rhodiola rosea and Camellia sinensis [green tea], the HHE board said. These ingredients are popular with nutraceutical companies and are claimed to offer a range of wellness, energy and weight loss benefits… and have been subsequently issued fines by the FTC for deceptive advertising, and warning letters from the FDA.

No weight loss product on the market has evidence for safety and effectiveness. One natural ingredient marketed to the public for weight loss, for example, is Garcinia cambogia. Few consumers heard that this was shown to be ineffective in clinical trials more than a decade ago. A randomized, double-blind, placebo-controlled trial by Columbia University obesity researchers found that the herbal compound failed to produce any statistical weight loss or fat mass loss over that seen in the placebo group.

At first, the FDA believed that the reports of Hydroxycut-related liver injuries may have been due to ephedra or Ma Huang, alone or in combination with the other ingredients, in the products. However, since Hydroxycut became ephedra-free in 2004, the liver-related adverse events have continued. The products have also undergone numerous formulation changes, making it difficult for the FDA to identify the potentially hazardous ingredient(s). Another ingredient that’s been found in variable amounts in the supplements is caffeine and the HHE board said that the doses recommended on the product labels would give people two to three times the average consumption of caffeine. The FDA identified 46 reports in CAERS of cardiovascular-related complications associated with Hydroxycut products, 19 after 2004.

Given the available information on liver and heart problems, most medical professionals are echoing the FDA’s concerns, as the potential serious risks outweigh taking supplements that offer no demonstrated health benefits.

Another health problem included in the CAERS reports provides an opportunity to better understand a condition that most consumers know little about, even though many might wish to.

Rhabdomyolysis

The FDA’s HHE report noted a case report of rhabdomyolysis involving a 23-year-old man who had been taking Hydroxycut intermittently for eight months in 2002. “On the day of hospital admission, he had taken two tablets for energy prior to working out,” the FDA said. The board said it was also aware of another case report in the medical literature seen in an 18-year old male.

That case report had come from the Department of Pharmacy Services at the University of Utah in Salt Lake City and described a previously healthy patient diagnosed with rhabdomyolysis. “His medications before symptom onset included Hydroxycut four caplets by mouth daily, naproxen sodium 220 mg by mouth as needed for pain, dextroamphetamine saccharate-amphetamine salts (Adderall) 15 mg by mouth once five days prior for a school examination, and hydrocodone-acetaminophen and cyclobenzaprine for pain,” said the authors. His history also revealed a recent increase in his exercise regimen.

These two case reports likely raised a questioning eyebrow among many medical professionals. Do you know why?*

It's the same reason seen yesterday in the Los Angeles Times. As so often happens whenever a health complication is linked to a pill or medical treatment, it becomes a potential class action windfall for lawyers. Yesterday, a feature story appeared in the newspaper describing a former Army serviceman, 27 years old, who had been diagnosed with rhabdomyolysis after an intense physical training session under his sergeant in July 2007. When the FDA’s recall of Hydroxycut made the news as being linked to two cases of rhabdomyolysis, the young man reportedly told the paper he’d remembered taking the supplement for three months in 2007. He is now a plaintiff in a planned lawsuit against maker Iovate Health Sciences, according to the newspaper. The story goes on to report:

Tropea says he was "completely shocked": How could an herbal supplement he took to trim down do all that?... Because rhabdomyolysis is most often the result of crush injuries, heat stroke, alcoholism or drug use, doctors thought it was unusual to see the condition in a fit, active-duty serviceman who, according to his military records, drank alcohol very rarely, had regularly passed drug tests, and had no recent history of trauma. Fearing a potentially disastrous recurrence, Tropea's physicians have warned against physical exertion of any kind…

Hydroxycut, Tropea believes, has left his health — and his future — uncertain. Tropea, who still lives in Stuttgart, is among the first wave of plaintiffs in a planned lawsuit against Iovate Health Sciences Inc., the maker of Hydroxycut… Tropea had not even thought to inform his doctors that he had been taking Hydroxycut steadily for the three months leading up to his hospitalization, in an effort to boost his fitness level and get down to the weight limits set for active-duty soldiers.

This news story was sad and may sway a future jury pool and garner additional clients for personal liability lawyers, but it raised some eyebrows among medical professionals.

Here’s why. Rhabdomyolysis has been widely recognized in the medical literature and among medical professionals for the past century as induced by exercise and even occurring in young, healthy people. Military physicians and military officers are especially cognizant of this common complication seen in recruit training. Doctors would not have found it shocking or unusual to see it in fit military trainees.

For example, a 1994 issue of Annals of Emergency Medicine, the journal of the American College of Emergency Physicians, reported on 35 patients seen in a New York emergency room with rhabdomyolysis after a history of strenuous exercise. All of them were men, with an average age of 24.4 years, and all had no medical history of health problems. “Exercise-induced rhabdomyolysis accounted for 47% of our admissions for rhabdomyolysis but was not responsible for a single case of acute renal failure,” the ER doctors concluded.

As Dr. Richard Sinert, and colleagues explained, since the syndrome was first described in 1910:

[N]numerous case reports have linked rhabdomyolysis to such strenuous activities as military basic training and weight lifting. Knochel has termed exercise-induced rhabdomyolysis "white collar rhabdomyolysis" because of its high incidence in intelligent, well-educated professionals who can arrange their work schedules to allow for daily running… this syndrome also has been reported commonly in professional athletes during marathon races and ice skating competitions.

Rhabdomyolysis appears to be a relatively common sequela of strenuous exercise. In the largest screening to date, Olerud et al sampled blood for myoglobin in 337 military recruits during their first six days of conditioning and found approximately 40% to have some degree of rhabdomyolysis.

“Rhabdomyolysis is a relatively common complication of strenuous exercise, as evidenced by the military recruit data and the large number of reports of "white collar rhabdomyolysis,” said Dr. Sinert and colleagues. “Reports of exercise-induced rhabdomyolysis in professional athletes support our experience that neither the amount of exercise nor the level of training appears to be a reliable predictor for the development of rhabdomyolysis.”

Reports of rhabdomyolysis occurring after exercise continue to appear regularly in the medical literature. In fact, while believed to be underreported, cases are increasing, as more and more people exercise, according to a 2004 article in The Physician and Sports Medicine, and it can develop at any level of physical exertion. For example, the Centers for Disease Control and Prevention reported exercise-induced rhabdomyolysis and acute renal impairment among New York City Fire Department recruits during competitive physical fitness tests in June 1988, resulting in 32 hospitalizations and one death. A 2005 report in the British Journal of Sports Medicine described 119 cases in high school students after repetitive exercise outside in cold weather. And the current issue of Clinical Advisor, reports a young 25 year old woman developed rhabdomyolysis after an aerobic spinning class. This syndrome can occur at any age. Beginning an exercise program precipitated rhabdomyolysis in a 63-year old woman who had also been taking a statin and using saunas for years.

Take-home information

Rhabdomyolysis means: striated (rhabdo) muscle (myo) disintegration (lysis). It is a series of potentially life-threatening complications that occur after muscles break down or are injured due to a variety of causes. When muscle breaks down, it releases muscle cells’ components (potassium, phosphate, myoglobin, creatine kinase and urate) into the bloodstream, leading to more muscle breakdown, shock, metabolic acidosis and hyperkalemia, kidney failure and disseminated intravascular coagulation. It accounts for up to 15 percent of cases of acute renal failure in the United States and is fatal for about 5 percent of patients.

Patients can develop any number of symptoms but about half will have darkened urine, prolonged weakness or aching muscles, cramps, muscle tenderness, swelling, confusion, seizures, nausea and/or fever. If you develop these symptoms, it’s important to seek medical care right away.

Exercise-induced rhabdomyolysis is more prevalent when physical activity is accompanied by heat and humidity, exposure to cold, dehydration and not drinking enough fluids. Sports medicine and emergency room doctors advise people to exercise wisely and not increase workouts more than 10 percent a week, even less in hot and humid weather, and to drink plenty of fluids. Early and generous hydration is the quickest way emergency room physicians also treat the condition to help prevent potentially life-threatening complications.

There are two other categories of causes of rhabdomyolysis. Genetic conditions are associated with about 10 percent of all cases. But the largest category of risk factors, which can work alone or synergistically, includes trauma, injury (crush or burn), substance abuse, toxins (such as tetanus or snake venom), infections, electrolyte abnormalities, inflammatory processes and a wide range of drugs. In the last one, prescription drugs, is the most common cause, accounting for nearly half of all cases. With prescription drugs being prescribed in greater number than ever before, awareness of this serious complication is more important than ever, too.

Rhabdomyolysis is a side effect of Adderall, mentioned in that FDA case report. But the public has most heard of rhabdomyolysis in connection with statins. Just between November 1997 and March 2000, the FDA received 871 reports of statin-associated cases of rhabdomyolysis, representing 601 cases. As reported in the Annals of Pharmacotherapy, the cases were associated with each of these statins: simvastatin, 215 (35.8%); cerivastatin, 192 (31.9%); atorvastatin, 73 (12.2%); pravastatin, 71 (11.8%); lovastatin, 40 (6.7%); and fluvastatin, 10 (1.7%). “Statins were designated as the primary suspect in 72.0% of the cases. Death was listed as the outcome in 38 cases.”

The FDA has issued repeated Consumer Alerts and Public Health Advisories about rhabdomyolysis and statins over recent years, such as:

August 8, 2001: FDA announcement of the recall of Baycol

March 2, 2005: Crestor (rosuvastatin) advisory

August 8, 2008: FDA alert on Zocor (simvastatin), especially at doses over 20mg daily and taken with amiodarone.

The Health Canada Advisory provides consumers with especially helpful safety information on rhabdomyolysis. Its 2005 advisory said rhabdomyolysis is “a serious side effect of all cholesterol-lowering drugs known as statins” which include:

Crestor (rosuvastatin)

Lipitor (atorvastatin)

Zocor (simvastatin)

Mevacor (lovastatin)

Lescol and Lescol XL (fluvastatin)

Pravachol (pravastatin)

Its statin advisory gave specific guidance for people, noting conditions that appear to place people at special risk for rhabdomyolysis from statins, including people with: thyroid, kidney or liver problems; diabetes; taking other medications or taking other cholesterol-lowering medications such as fibrates or niacin, do physical exercise, have had surgery or other injury, or family history of muscular disorders.

The bottom line, is that the decision to take any pill — all-natural dietary supplement, over-the-counter, or prescription — should not be made lightly. The decision means carefully balancing the demonstrated health benefits in treating an actual medical problem with the potential side effects. All drugs have side effects. Popping a pill, any pill, isn’t recreation. It can have serious consequences.

© 2009 Sandy Szwarc

* Looking back to those two case reports cited by the FDA of rhabdomyolysis occurring in two young men — both following intense physical workouts of increased intensity and taking Hydroxycut supplements — the correlation alone makes it impossible to parse out with certainty if the cause was the exercise or the supplement, or both. Or, it could have been the Adderall? Or some combination?

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Memorial Day 2009

Today, we remember and pay tribute to the men and women who have paid the ultimate sacrifice to defend our country and ensure our freedoms. Thank you for your service, strength and valor.

Flags will be flying at half staff in honor of another hero, John Brown, Jr., one of the original Navajo Code Talkers and a Navajo Councilman, who died this past week.

The 29 Navajo Code Talkers had developed a secret code based on their native language, which was never deciphered by the Japanese and is credited with contributing to victory in the Pacific theater of World War II and saving thousands of lives.

"We have seen much in our lives; we have experienced war and peace; we know the value of freedom and democracy that this great nation embodies. But, our experiences have also shown us how fragile these things can be, and how we must stay ever-vigilant to protect them. As Code Talkers — as Marines — we did our part to protect these values. It is my hope that our young people will carry on this honorable tradition as long as the grass shall grow and the rivers flow." — John Brown, Jr. (1921-2009)

The secret project wasn’t declassified until 1968. As Navajo Tribal President Joe Shirley said: “For so long, these brave men were the true unsung heroes of World War II, shielding their valiant accomplishments not only from the world but from their own families. The recognition and acknowledgment of their great feats came to them late in life but, for most, not too late. These heroes among us are now a very precious few, and we, as a nation, mourn their loss. We offer our deepest condolences to the family of Mr. John Brown Jr.”

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

Junkfood lowers children's IQ and other myths

Last week, more than 400 news stories in just two days reported that a study had found conclusive evidence that fast food makes children stupid and lowers their school tests scores. How many journalists do you think actually went to the original source and read the study?

None.

How can we be so sure?

Because there is no published study in a peer-reviewed journal. There was no ability for educational or health professionals, let alone a journalist, to examine the research and its methodology, data and interpretations.

The study turned out to have been an abstract and paper* presented at a table at the American Educational Research Association’s annual conference in San Diego, California, more than a month ago — on April 16th between 1:15 pm and 1:55 pm. The American Educational Research Association is a professional organization of educators; administrators; directors of research; people working with testing or evaluation in federal, state and local agencies; counselors; evaluators; graduate students; and behavioral scientists. The abstract submitted to the conference program had been presented by a student from Vanderbilt University’s Peabody College of Education and Human Development in Tennessee, the nation’s #1 rated graduate school for education by U.S. News.

Going to the AERA’s meeting program finds the abstract:

Abstract:

That children in the United States are experiencing an epidemic of overweight and obesity is largely accepted by both the popular media and the educational research community. What has not yet been shown by research, however, is a link between consumption of one of the suspected obesity culprits, fast food, and students’ academic performance in school. This paper reports the results of a preliminary regression analysis, using propensity-score matched ECLS-K data, demonstrating a negative relationship between 5th graders’ reported fast-food consumption patterns and their reading and math test scores. Possible policy implications and directions for further research are discussed.

Before we examine this abstract in more detail, why did this obscure student paper suddenly make news headlines more than a month later? Here we have an example of media and ‘studies’ being used for marketing to advance an ideology and agenda.

Plenty of people want us to fear that foods that are not processed from scratch by Mom at home contain unseen ingredients that somehow make the foods unhealthy, “junkfood” and dangerous for children. They count on us to not understand nutritional science, or biology or cooking or chemistry or statistics.

The source of this recent media blitz was an article published in the Times Educational Supplement on May 22nd. TES is an online social network and job search engine for teachers in the UK. It was written by Adi Bloom, a reporter who covers the arts for TES. Within hours, her report had found its way around the world and to the United States.

Ms Bloom’s article was widely repeated nearly verbatim in the UK press — where the campaigns of young celebrity chef Jamie Oliver and the government’s Change 4 Life have been actively trying to eradicate “unhealthy” foods from children’s diets to slim them down— in stories with headlines like: “Fast food diet makes children more stupid” and “Too much fast food 'harms children's test scores.” The scary thing was that the Press Association thought being written up in a social media publication made this a “published study,” and even the education editor of a national newspaper took the TES article as its source for reporting the research.

It’s like that old game of telephone, where a string of people repeat what they’ve heard, with the story becoming more inaccurate and sensationalized with each telling. Although today, news can spread via the internet faster than Mark Twain might ever have imagined.

A lie can travel halfway around the world while the truth is putting on its shoes. — Mark Twain (1835 - 1910)

As Ms Bloom reported:

Fast-food diet can result in slow-brain children

US study finds direct link between consumption of junk food and academic performance. Eating too much fast food can affect pupils’ intelligence, seriously undermining their academic ability, according to new research. Kerri Tobin, of Vanderbilt University in Tennessee, studied the impact of a fast-food diet on the schoolwork of more than 5,500 10 and 11-year-olds. She found that those who ate higher-than-average amounts of junk food scored significantly lower than their classmates in a range of academic tests…

Until now, however, no research has shown a conclusive connection between high-fat and sugary foods and low academic results. Inspired by Jamie Oliver’s campaign to expunge the Turkey Twizzler from school lunch menus, most British schools have removed unhealthy snacks from vending machines, tuck shops and dining halls. But Dr Tobin decided to test whether eating habits out of school also had a significant impact on pupils’ achievement. She therefore asked 5,500 primary pupils to record how many times a week they ate at fast-food restaurants such as McDonald’s or Wendy’s…

Dr Tobin found no correlation between pupils’ fast food consumption and their weight, or between their parents’ income and the amount of fast food they ate. But there was a direct correlation between how much junk food they ate and their scores in a series of literacy and numeracy tests.

Ms Bloom went on to report that students who said they ate fast food daily scored 16.07 points below average in reading and those who ate it three times a day dropped 19.34 points. Math scores were similarly lower by 14.82 points and 18.48 points, respectively. “Overall, higher-than-average consumption of fast food resulted in lower- than-average test scores: 12.79 points less for reading and 12.35 points for numeracy,” she reported. According to a fast food restaurant spokesperson, most customers visit their restaurants two to three times a month.

Tobin was quoted as speculating that perhaps “the propensity to eat fast food is correlated with unobserved characteristics, like parental involvement in homework, which would also affect test scores” and proposing other nonsensical explanations like “the types of food served at fast-food restaurants cause cognitive difficulties that result in lower test scores” or that “pupils eat fast food as a means of coping with low test scores, reversing the cause-and-effect pattern.”

Had any reporter or editor gone to the original source material and understood it, they would have instantly realized that none of the claims they were hearing were credible. Since no one has cared to in more than a month, let’s take a look.

ECLS-K database

This study wasn’t a study as most consumers think that term means. It wasn't an intervention trial and dietary analyses or academic testings were not performed on the children and the children then followed to see if those eating more of certain types of fast food ended up with lower academic scores than a control group. The fifth grade reports in the ECLS-K database were dredged and, using computer modeling, a correlation found between undefined “junkfood” and selective test scores.

The Early Childhood Longitudinal Study, Kindergarten Class of 1998-99 (ECLS-K) is a national observational study database under the U.S. Department of Education’s National Center for Education Statistics. It includes five surveys of descriptive information: student assessments, parent interviews, self-administered questionnaires from principals and teachers, and abstracts of student records from a nationally representative sample of children from kindergarten to eighth grade.

The most recent information on the children in eighth grade (from 2007) was not used. Instead, the fifth grade data was used. As the ECLS-K Psychometric Report for the Fifth Grade states, “the fourth- and fifth-graders in the field test were different children, not longitudinal measurements of the same children.”

The dietary information available from the fifth graders came from a self-administered questionnaires, containing 19 questions asking the kids to remember how many times they had consumed a list of foods and beverages over the previous seven days. Few adults could probably accurately remember everything they’d eaten for a week, let alone elementary school age kids. But none of the children’s answers were even confirmed by their parents or guardians.

Interestingly, correlations between test scores and any of the other foods or beverages the children reported eating were not reported. It called to mind the example given by Eric Meyer, with the College of Media at the University of Illinois, Urbana-Champaign, cautioning us to beware of incomplete data and seeing only what we think makes sense:

My personal favorite was a habit we use to have years ago, when I was working in Milwaukee. Whenever it snowed heavily, we'd call the sheriff's office, which was responsible for patrolling the freeways, and ask how many fender-benders had been reported that day. Inevitably, we'd have a lede that said something like, "A fierce winter storm dumped 8 inches of snow on Milwaukee, snarled rush-hour traffic and caused 28 fender-benders on county freeways" — until one day I dared to ask the sheriff's department how many fender-benders were reported on clear, sunny days. The answer — 48 — made me wonder whether in the future we'd run stories saying, "A fierce winter snowstorm prevented 20 fender-benders on county freeways today."— Eric Meyer

The focus was on Question #19, which asked the children about fast food:

Notice that the children were given no information on how a portion or snack was defined, they were asked only how many times they had eaten something from a fast food restaurant. The children were likely easily misled by the multiple choices, but how many parents do you know who drive their children to a fast food restaurant three or four times a day? Nor was there any attempt made to determine the type of food or the amount of food eaten: a bite, a nibble, a single fry or a fast food salad, fruit cup or carton of milk.

With this dubious dietary information, she then reported correlations to math and reading scores from the fifth grade assessments on just over 5,500 children. Going to the actual Psychometric Report for the Fifth Grade, however, finds that reading and math tests had been done on 11,267 children during the 2003-4 school year. We have no explanation for why more than half of the data was not used and we know nothing about the children who were included or excluded. Like studies released at meetings, this study wasn’t published in a journal and available to the scientific community for any critical peer review.

As we know, data dredges can find just about any correlations a researcher sets out to find, along with plenty of meaningless and spurious correlations, depending on the data selected, the assumptions made in their regression computer modeling, and the confounding factors considered or ignored. Even then, correlations can never prove causation.

As the ECLS fifth grade findings report cautions:

Readers are cautioned not to draw causal inferences... It is important to note that many of the variables examined in this report are related to one another, and complex interactions and relationships have not been explored here. The variables examined here are also just a few of the variables that can be examined…

According to the fifth grade findings from the ECLS-K, issued by the U.S. Dept. of Education, a multitude of factors were seen associated with test scores, such as:

● health and learning disabilities of children are known to affect performance on standardized tests

● poverty status (61 percent of students in households below the poverty line scored in the lowest third of reading scores, compared with 25 percent of students in households at or above the poverty threshold)

● economic and food security (children living continually in poverty scored lower than those moving in and out of poverty)

● mother’s education level (children of mothers with at least a bachelor’s degrees scored higher)

● educational focus and learning opportunities at home, also seen in ethnic disparities (whites and Asian students scored higher than other minority or disadvantaged children)

● primary language at kindergarten (children from homes where English was the home language when they started school had higher reading scores than those where English was not spoken at home)

● type of school (children in private schools scored higher than those in public schools)

● school and home stability (children who transferred from private to public, or who changed schools frequently and lived in multiple different places between kindergarten and fifth grade scored lower than children from more stable situations)

● absenteeism, especially in kindergarten, was also found to affect school achievement, according to the ECLS-K data (kindergarteners who missed 10% or more of the school year scored lower than those who were able to attend more classes during the school year)

● computer access and type of computer learning opportunities (children in the ECLS-K class with access to computers at home and school were found to associated with higher social skills and academic performance, especially language development, than youngsters without computer access)

● and more.

Yet, while all of these variables were available in the database, we were provided no evidence that any of these factors were considered in Tobin’s computer regression model… or if they were used… when deriving the correlations.

In the end, the faulty methodology was made even more meaningless by the inaccessible findings. We don’t know the children’s mean test scores and standard deviations to make any credible comparisons. As the ECLS-K fifth grade report noted: The mean reading scores among all the children was 136.7, with a 24.3 standard deviation. The math mean score was 111.2 with a standard deviation of 22.4.

The reported small 12-point average differences in the reading and math scores among children supposedly eating fast food three times a day compared to those with average consumptions was less than the wide standard deviations among the ECLS-K tests. There was no tenable correlation demonstrated. Hearing only what we were supposed to conclude doesn’t mean that’s what the data actually supports.

Yet, reported correlations were turned into causations and then flipped into reverse and used to make school policy recommendations for interventions that had never been tested and had absolutely no evidence to support their safety or effectiveness. That is not, ideally, how education or health professionals decide the best care for children. Never the less, Tobin insisted, according to Ms Bloom, that “continued investment in school nutrition plans, and curricula designed to make pupils and parents aware of the academic consequences of their food choices, would be one positive step that schools could take.”

“If you eat that, it will make you stupid” is not a positive, helpful or credible nutritional message for young children or their parents.

© 2009 Sandy Szwarc

* Correction: It was not a poster, as originally noted per the conference program.

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

The new national school health policy — a look at the evidence

How much money does it take to buy your child’s educational curriculum?

$269,000

That’s all it took to get curriculum standards for our nation’s schools published, as well as policies “to fight childhood obesity and promote healthy eating and physical activity” developed and mandated in schools by State Boards of Education… without any sound evidence that they are effective or safe.

The National Association of State Boards of Education had been awarded $269,000 from Robert Wood Johnson Foundation to fund its Obesity Prevention Project. The NASBE Obesity Prevention Project was tasked with providing school boards and education officials nationwide with the “best and promising practices, evidence-based research, and access to top school health and nutrition experts to help states develop education policy solutions to the childhood obesity epidemic,” said Brenda Welburn, NASBE Executive Director. Working with 14 state teams, the NASBE revised the State Education Standard with a special Obesity Prevention edition and issued a policy brief on obesity prevention policies. The NASBE State School Healthy Policy Database describes the curriculum standards that its participating states have mandated for nutrition and healthy lifestyles to date.

The NASBE Obesity Prevention Project just published its “Preventing Childhood Obesity: A School Health Policy Guide.” Its opening paragraph, presenting its rationale for obesity prevention, states:

Preventing childhood obesity is a pivotal issue for the United States that requires top priority attention from policymakers at all levels of government. An ever-expanding base of credible evidence indicates the childhood obesity epidemic has far-reaching consequences for the nation’s public health system, economy, and overall prosperity. The epidemic is even more pronounced for children, whose development is being adversely impacted not only physically and mentally but also academically.

Let’s look at the credible evidence-based information and practices presented in this new national school policy for our children and families.

Child obesity epidemic and health crisis

The NASBE School Health Policy Guide says: “This nation is facing a serious childhood obesity epidemic. Today 16.3 percent of children and adolescents ages 2 to 19 are obese [defined as ≥ 95th percentile on new the BMI growth curves], and 31.9 percent are obese or overweight [defined as ≥ 85th percentile on the growth curves]... During the past four decades, the obesity rate for children ages 6 to 11 has more than quadrupled (from 4.2 to 17 percent) and more than tripled for adolescents ages 12 to 19 (from 4.6 to 17.6 percent).”

Fact checks: The epidemic that wasn’t (since the childhood growth charts and NHANES surveys were redesigned a decade ago by the CDC, there have been no statistical change in the percentages of young people at or above the 95th percentile on those growth curves), Where’s the crisis (creating an epidemic based on “prevalence” — the numbers of children crossing the threshold of new cutoffs defining overweight, not on actual weight and height changes, which have been surprisingly small over the past half century…), Misplaced priorities for children (how perceptions of an epidemic are created), Obesity staticulations (misleading with staticulation and chartsmanship; the difference between natural diversity of physical shapes and sizes and a contrived epidemic), New Age Numerology (child and teen normal growth and development, growth curves and definitions), Advocacy for whom? (media images and marketing versus reality)

The NASBE School Health Policy Guide says: “Obese and overweight children are likely to suffer health consequences not only during childhood and adolescence, but also throughout their adult lives. They are at greater risk as children and as adults for bone and joint problems, sleep apnea, social and psychological problems, heart disease, type 2 diabetes, stroke, cancer, and osteoarthritis... it is critical to prevent obesity and overweight in childhood before these chronic health problems arise.”

Fact checks: Is it for real? (obesity and diet has nothing to do with the extremely rare genetic disorder of familial hypercholesterolemia; National Health and Nutrition Examination Survey data shows there’s been no increase in lipid and lipoprotein levels in children, adolescents or adults since at least the 1960s; U.S. Preventive Services Task Force examined 81 quality clinical studies and found no evidence that diet or exercise interventions in childhood improve lipid profiles or result in better health outcomes in adulthood; USPSTF found that low-fat diets, most popularly referred to as ‘healthy eating,’ not only lack evidence of effectiveness in reducing obesity, cholesterol levels or risks for heart disease, but they found evidence to suggest harm for children and teens, who need fats; body fat itself is unrelated to atherosclerosis), Helping to protect children from wrong diagnoses (blood pressures have not increased for decades and blood pressures in children and teens have not been shown to identify those at risk of later getting heart disease), How real is the crisis of undiagnosed hypertension in children?, Does it really matter how your numbers measure up? (no body measurement or body composition is predictive of higher risks of dying from all causes; National Center for Health Statistics at the CDC found all-cancer mortality was unrelated to any BMI category), Fat and long life — The “obesity” crisis is crumbling (there were no significant relations between BMI and overall, cardiovascular disease, or cancer mortality risk), One more time: fatness not linked to overall cancer risks, and the Obesity Paradox series

The NASBE School Health Policy Guide says: “Early indicators of atherosclerosis, which is associated with poor dietary habits and is the most common cause of heart disease, can already be found in many children and youth... In fact, a recent study conducted by the University of Missouri Kansas City’s School of Medicine shows that obese children as young as 10 had thickened arteries more commonly seen in 45-year-old adults. The findings, one researcher said, suggest that cardiovascular disease could someday become a pediatric illness.” The reference cited for this claim was the New York Times newspaper article.

Fact checks: Questions media didn’t ask.

There is no evidence linking child nutrition to heart disease or that “heart healthy” diets are healthy for children: The big one — results of the biggest clinical trial of healthy eating ever, Food and heart attacks — is a link for real?, Low-fat is not for kids, Making it up on volume, Feeding our children well, Brain food for kids: Having enough to eat, Toddlers and bunnies.

The NASBE School Health Policy Guide says: “Of particular concern is the rapidly rising rate of diabetes. Overweight and obesity, especially at younger ages, substantially increase a person’s lifetime risk of diagnosed diabetes; the risk of diabetes among 18 year olds who are obese is 70 percent for men and 74 percent for women.”

Fact checks: Phantom epidemic of child diabetes (NHANES data of actual physical exams and blood tests on representative samples of the population have tracked type 2 diabetes in young people for more than two decades and show no change in the prevalence of type 2 diabetes for more than two decades; rates among young children are so low they can’t even be measured and appear in only about 0.04% to 0.15% of teens; there’s not even a hint of an impending epidemic; obesity is not a factor for impaired glucose tolerance; prediabetes isn’t predictive of anything; type 2 diabetes is considerably more genetic than type 1 diabetes and moreso than even height; and type 2 diabetes is not brought on by eating bad foods or having a bad lifestyle; “Bad eating habits such as too much refined sugars, empty carbohydrates and fructose do not cause diabetes.”) A costly truism that’s not true — obesity has led to an epidemic of type 2 diabetes in young people, Government health officials decide it’s acceptable to bully fat children

The NASBE School Health Policy Guide says: “1 in 3 children born in the new millennium can be expected to live substantially shorter lives than those in the previous generation.”

Fact checks: The sky is not falling, Health of the nation — Did you hear the good news? (we are not dying in record numbers from unhealthy lifestyles and modern life is not killing us; children today are not sicker or expected to live shorter lifespans than their parents; according to the CDC, babies born in 2006 are expected to live 80.7 years for girls and 75.4 years for boys, a steady increase for more than a century; today’s children are nearly five times less likely to die in childhood compared to children born in 1950; CDC data reports 98.2% of American children and teens are in good or excellent health)

The NASBE School Health Policy Guide says: “Obese children are two to three times more likely to be hospitalized and are about three times more costly to care for and treat than the average insured child… Children covered by Medicaid account for $3 billion of those expenses. Annually, the average health expenses for a child treated for obesity under Medicaid is $6,730, while the average expenditure for all children on Medicaid is $2,446.”

Fact checks: Fat children burdens? (It turns out, there is no correlation between a young person’s BMI and emergency room usage or visits to the doctor. Higher medical expenses are not because fatter children are sicker. They were 5.5 times as likely to have extensive laboratory and screening tests ordered in accordance with Medicaid guidelines for fat children or children with a family history of obesity, despite no evidence for efficacy. Then, the costs of those added medical tests are used to blame the fat children for raising health costs!)

Increasingly, Medicaid recipients must follow the state’s prescribed healthy diets and preventive wellness management in order to receive benefits, such as care for their special needs children.

BMI screenings — weighing the efficacy and harm

The NASBE School Health Policy Guide says: “Arkansas’ Act 1220 was the first state policy to mandate BMI screenings in school. The results are kept confidential and sent to the parents in a Child Health Report that contains evidence-based guidance for parents to help improve their child’s weight status, tailored to the individual students’ BMI screening results.”

Fact checks: School childhood obesity and BMI screening legislation update (a review of the CDC policy brief “Body Mass Index Measurement in Schools”; after its comprehensive review of the evidence, the U.S. Preventive Services Task Force concluded that there is no quality evidence to support that childhood “overweight” or “obesity” is related to health outcomes and that the evidence shows that BMI fails to predict fitness, blood pressure, body composition or health risk. A recent 50-year prospective study found no association between children’s BMI and heart disease later in life, and other research found weight to be unrelated to children’s risks for insulin resistance. The USPSTF found no evidence to support routine screening for overweight in children and adolescents as a means to improve health outcomes, but did note potential harms of screening programs. The USPSTF concluded that no scientific review has been able to find any quality evidence that any programs to reduce or prevent childhood obesity — no matter how well-intentioned, comprehensive, restrictive, intensive, long in duration, and tackling diet and activity in every possible way — have been effective, especially in any beneficial, sustained way; nor have they been able to demonstrate improved health outcomes or physiological measures, such as blood lipids (“cholesterol”), glucose tolerance, blood pressure or physical fitness. Nor has any diet or exercise interventions in children been shown to lead to better health outcomes in adulthood. The USPSTF found no evidence to support the effectiveness of counseling for healthy eating in young people or to support low-fat diets in children, but growing evidence for harm.), When schools grade looks (parents share the actual BMI letter received from school officials and found the guidance was far from evidence-based), parents can just say “no”, BMI screening and BMI report cards

The NASBE School Health Policy Guide says: “Recent studies have found that many families of overweight and obese children do not recognize that fact, with most families underestimating the severity of their child’s weight situation. Thus, BMI screening can prove to be a powerful tool for both schools and families.”

Fact checks: The faces of childhood obesity (a mere 5 pounds makes the difference between a first grader being labeled as ‘normal’ or ‘obese’), By who’s definition?, Clueless parents? Not necessarily, Actual pictures of childhood overweight, Reader feedback and reactions

The NASBE School Health Policy Guide says: “Many parents worry that their child, if labeled as obese or overweight, will be subject to bullying and harassment. A University of Arkansas study of the Act 1220 policy [sponsored by RWJF] has found that there has yet to be any increase in teasing since the state implemented mandatory BMI measurement.” [No mention was made of any other adverse effects being shown from childhood obesity programs.]

Fact checks: Does the evidence really show that school obesity policies and weigh-ins don’t increase taunts against fat kids?, Innocence lost. Health messages are not harmless, Remember the BMI report card debate? (Act 1220 has failed to have any measurable effect on children’s weight status; failed to demonstrate meaningful improvement in their overall diets or physical activity levels; failed to demonstrate improved health outcomes; and there are growing indications that it is causing harm, especially to girls and minorities), The country’s most massive childhood obesity program — has it helped children?, Teaching tots — what our youngest children are internalizing from the war on obesity (striking and disturbing evidence of adverse consequences for children and teens of anti-childhood obesity programs promoting healthy eating and exercise)

If we forge ahead with an intervention (whether therapeutic, preventive or even diagnostic) without knowing whether it is beneficial, we run the risk of causing unintentional harm. — U.S. Preventive Services Task Force Childhood Obesity Working Group, “Screening and Interventions for Childhood Obesity”

Physical activity

The NASBE School Health Policy Guide says: “[A] large number of students still do not receive opportunities to be physically active, as 64 percent of high school students do not meet their quota for daily recommended physical activity.”

Fact checks: Telly tubby myth (no correlation found between TV watching and levels of physical activity; CDC data found walking and biking among young people haven’t declined in decades, but children are bicycling nearly three times more and walking has increased 12% since 1977; time spent in organized sports and outdoor activities increased by 73 minutes per week between 1981 and 1997 for younger children, with no change among teens), Myth of sloth (the government’s own evidence doesn’t support fears that we’re a nation of couch potatoes or that sedentary behaviors are a new public health crisis), Myth of sloth slayed again (using doubled labeled water method and direct measures of basal energy expenditure by respirometry, researchers found no indication that physical activity or calories burned in activity have declined since the 1980s), No support for finger pointing teens (the Steering Committee of the National Institute of Child Health and Human Development Study of Early Child Care and Youth Development found no support for the popular belief that low-income kids are more sedentary, as they were actually significantly more active than kids from higher incomes), Fact or Fiction? Kids today are fat because they’re not getting enough PE (the largest systematic review of the evidence on school-based physical activity interventions to date found no statistical difference between the BMIs of children who received school based physical activity interventions and those in the control groups and concluded: “Current population-based policies that mandate increased physical activity in schools are unlikely to have a significant effect on the increasing prevalence of childhood obesity.”), Whipping kids into shape (examining evidence on fitness and overweight among school-age youth found no credible support that levels of physical activity and fitness among fat children are less than thinner kids to explain their diversity in sizes)

The NASBE School Health Policy Guide says: “A scientific consensus has emerged that every young person needs to participate in at least 60 minutes of moderate to vigorous physical activity daily… If time is made for physical education and supervised recess, then kids are more physically active; and if they are more physically active, then they expend more calories and are closer to achieving an energy balance.” [The only paper cited had no evidence for 60 minutes a day of exercise in young people, it looked at short-term intervention studies of supervised programs of moderate to vigorous physical activity of 30-45 minutes and the “panel believed that a greater amount of physical activity would be necessary…”]

Fact checks: Is school PE really the answer to “childhood obesity?” (U.S. studies of fitness, examining actual peak oxygen consumption measurements, indicated that there has been little change in absolute and relative peak V-O2 levels in children from the 1930s through the 1990s; reduced participation or time spent in school athletics or physical education does not translate into significant differences in total daily energy expenditures among children; child exercise physiologists caution that young people are not little adults and 60-90 minutes a day of sustained activity in structured or organized activities, exercise or sports is inappropriate; there have been dramatic increases in extracurricular sports and physical activities among young people since the 1960), Fact or Fiction? Kids today are fat because they’re not getting enough PE (not one study has found physical activity interventions — no matter how intense, prolonged or type — to have an effect on children’s BMI)

The NASBE School Health Policy Guide says: “[T]he evidence is compelling that regular physical activity improves academic performance...The study found that physical activity has a positive influence on concentration, memory, and classroom behavior and that the addition of P.E. to the curriculum can result in small positive gains in academic performance.”

Fact check: Take home message from school: Kids, spend as little time reading as possible (examining the research claiming fitness improves academic scores, underscoring the importance of “correlation is not causation”)

Healthfulness of school lunches and kids’ diets

The NASBE School Health Policy Guide says: “[T]he latest findings from the third School Nutrition Dietary Assessment Study (SNDA-III)...shows that among schools participating in the National School Lunch Program, only 6 percent offered lunches that met all of the School Meal Initiative standards for energy, fat, saturated fat, protein, Vitamin A, Vitamin C, calcium and iron. Other SNDA-III findings showed that 42 percent of schools did not offer any fresh fruits or raw vegetables in the reimbursable school lunch on a daily basis. In addition, the study indicated that one or more sources of competitive foods, typically characterize as low-nutrient, energy dense foods and beverages, were available in 73 percent of elementary schools, 97 percent of middle schools and 100 percent of high schools.”

Fact checks: School lunches — Are kids eating healthfully? (an examination of the third School Nutrition Dietary Assessment (SNDA) study found the data didn’t support the claims and alarm about the unhealthfulness of children’s diets), Brain food for kids — having enough to eat (school lunch reports from School Nutrition Association and NHANES dietary surveys found the majority of children’s dietary intakes are well within the 2005 Dietary Guidelines), Another from the recommended reading file (stories of the horrible diets of today’s children found to be gross exaggerations), We're not eating so badly, Are kids really eating that badly? (government data reveals that since the 1960s, children and teens are eating less fat, fewer calories, more fruits and vegetables, and more dairy), Our kids are doomed-not!

Healthy eating and nutritional education being taught in schools

The NASBE School Health Policy Guide says: “Additionally, nutrition education and physical education should be closely aligned to reinforce the importance of the “calories-in/calories-out” energy balance equation that is critical to maintaining healthy weight.”

Fact checks: First law of thermodynamics, No tomorrows, Cradle to grave customers

The NASBE School Health Policy Guide says: “Integrated Policy to Promote Healthy Eating. All schools shall encourage and provide opportunities for students and staff members to practice making healthy eating choices on a daily basis, and shall educate every student on essential knowledge and skills for a lifetime of healthy eating... The integrated policy shall include...a sequential program of behavior-focused nutrition instruction that aims to influence students’ knowledge, attitudes, planning skills and eating habits; is part of the comprehensive school health education curriculum.”

Fact checks: We’ve seen the government’s and schools’ unsound ideas of healthy eating education for young people in Government diet plan for girls, "Eat Smart" teaches children, Of concern to parents: what are children really being told in school?, What do healthy eating and lifestyles have in common with woo?, This is scholastic achievement?

The NASBE School Health Policy Guide says: “Because schools are singular entities where the interests of community, families, and government intersect, we can start to reverse the obesity epidemic by implementing and enforcing positive policies and practices in schools nationwide... If schools limit competitive foods and provide appetizing school meals that meet dietary guidelines, in appealing circumstances with sufficient time to eat, then they will consume appropriate calories and come closer to achieving an energy balance. If schools have a healthy environment for eating and physical activity, and community and family environments are also healthy, then children will achieve an energy balance and maintain healthy weight.”

Fact checks: The two-year Comprehensive School Nutrition Policy Initiative study for reducing childhood obesity — an intensive study which included every school-based program recommended in the U.S. Centers for Disease Control and Prevention’s “Guidelines to Promote Lifelong Healthy Eating and Physical Activity” — was supposed to have provided the evidence for school wellness policies. It failed on all counts. The results were reported in a JFS Special Report: Major findings on childhood obesity programs.

Overwhelmingly, school, community and clinical child obesity prevention programs continue to fail: Stepford kids (the results of the “Shape Up Somerville” project, where every exercise, sports, healthy eating and weight management program in town and in schools focused on losing weight), New CME for doctors — What wasn’t said about childhood weight management (findings issued by the U.S. Preventive Services Task Force after examining 40 years of evidence, about 6,900 studies and abstracts, on childhood obesity initiatives), Experimenting on a new generation, Evidence-based childhood obesity programs — another case of mistaken definition, What you may not know about childhood obesity programs, The country’s most massive childhood obesity program — has it helped children? (the findings of Arkansas 1220, the most extensive and costly childhood obesity program in the nation, focused on schools and communities), Remember the BMI report card debate?, Innocence lost — health messages are not always healthful, and If we passed out grades for science (national data shows that after 15 years, the entire 5-A-Day for Better Health Program first launched by the National Cancer Institute to increase consumption of fruits and vegetables as part of a low-fat, high-fiber diet, has been a dismal failure)

They knew there was no evidence for their childhood obesity prevention proposals when they started.

Presently, there is limited experimental evidence regarding the best ways to prevent childhood obesity and the extent to which various potential factors contribute to weight gain.— Institutes of Medicine, “Preventing Childhood Obesity: Health in the Balance,” commissioned and funded by RWJF

But that wasn’t a deterrent then.

There are ‘natural experiments’ taking place...but we can’t afford to surrender an entire generation of kids to the obesity epidemic while we wait for perfect answers. — Risa Lavizzo-Mourey, M.D., President and CEO of RWJF, which committed $500 million “to reverse the epidemic of childhood obesity in the United States by 2015”

And the evidence since then hasn’t been a deterrent, either. — Evidence that continues to show that promoting ‘healthy eating and physical activity’ fails to reduce child ‘obesity’ rates or to benefit children’s health, and is increasingly showing harm. — Evidence that isn’t surprising at all, since their proposals weren’t based on sound premises to begin with.

Only in a doublespeak world is it possible to create so much from so little… to convince people to believe and see a reality that is far from real.

© 2009 Sandy Szwarc

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