July 4th — Life, Liberty and the Pursuit of Happiness

This Independence Day is a good day to read the Declaration of Independence, signed by our Founding Fathers on July 4, 1776, and remember what this day means. Most importantly, to teach our children.

We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty and the pursuit of Happiness. That to secure these rights, Governments are instituted among Men, deriving their just powers from the consent of the governed…

Most importantly, to teach our children. “An understanding of government and history are crucial to the preservation of liberty and our democratic institutions,” wrote Matthew Ladner, Ph.D., Vice President for Research at the Goldwater Institute. “A major justification for supporting a system of public schools has long been the promotion of a general civic knowledge necessary for a well informed citizenry.”

A test of civic knowledge was given to a representative sample of Arizona high school students, asked them ten questions from the U.S. Citizenship and Immigration Services exam. This is the test administered to new immigrants in order to become U.S. citizens. More than 92 percent of first-time immigrants taking the exam pass.

These ten questions were the most basic imaginable. The results were released last week by the Goldwater Institute. Not one of 1,134 students answered all ten questions correctly, or nine questions correctly, or eight questions correctly. Less than 1% could answer seven questions correctly. Only 3.5 percent of public high school students could correctly answer even six of them, a score necessary to pass the basic citizenship test.

More than 96 percent of Arizona public high school students would get an F in Civics. The voting age is 18, but three out of four students don’t know the two parts of Congress, the Senate and House of Representatives; and three out of four don’t know that the President oversees the executive branch of the government.

Three out of four high school students didn’t know who was George Washington.

Three out of four high school students didn’t know who was Thomas Jefferson.

This study sounds an alarm, said the Goldwater Institute. Our Founding Fathers cautioned repeatedly that preserving individual liberties and a free society would only be possible with a well-informed citizenry that understood the virtues essential to preserving the Constitution.

Whenever the people are well-informed, they can be trusted with their own government… Enlighten the people generally and tyranny and oppressions of body and mind will vanish like evil spirits at the dawn of day. — Thomas Jefferson

In the Declaration of Independence, individual rights is an absolute. The Founding Fathers strongly advocated reason. A population taught to think rationally is freer. An uneducated populace is more easily controlled, made to feel they are helpless and dependent, to doubt their own reason and their own worth, to be led to elevate the State above the individual, and to be oppressed. Education is a threat to power and control over individuals.

Thinking and reasoning are critical to preserving independence, as well as people’s autonomy over their own bodies and how they choose to live their lives. The problem is even bigger than not knowing basic civics and history, dooming future generations to not understanding the hard-learned, hard-fought lessons of history. When students don’t know how to read, don’t understand math or have basic scientific literacy (critical thinking and reasoning), the door is opened to pseudoscience and believing anything they are told.

When two thirds of high school juniors flunked the state’s math proficiency exams — which students are given three tries to pass in order to graduate from high school — what was the Minnesota legislature’s solution? They decided to ditch the requirement that students pass basic math and reading tests to receive a high school diploma.

In Florida’s DeSoto County schools, as few as 20 percent of high school sophomores passed basic reading proficiency tests. Less than one-third of North Port high school juniors passed basic science proficiency. Statewide, only 37 percent of Florida sophomore students performed at or above their grade level in reading and less than half in science.

It’s not the students’ fault, it’s the failure of adults. In Massachusetts, two-thirds of aspiring elementary school teachers failed the math section of the state’s teaching licensing exam. That state’s solution was to allow the 73% who flunked to still get teaching licenses. The teachers would then have five years to pass the test.

This Independence Day is a day to remind ourselves of the vision of our Founding Fathers and to begin by teaching our children well. Our Government was founded by thinking men for a single purpose: to protect and defend our inalienable rights to life, liberty and the pursuit of happiness. It was a radical idea at that time and shouldn’t be today.

It’s a good day to read the Declaration of Independence.

Happy 4th of July!

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Even obesity paradoxes can’t “excuse” fatness

I wasn’t going to even cover this study looking for correlations between obesity and risks of dying. The predominance of evidence and carefully-designed studies have repeatedly failed to support BMI a measure of health or predictive of our risks for dying. The value of null studies is wasted with yet more research in that direction. But this study has been so widely misrepresented in the media, that a quick look at what the data actually revealed may be helpful and clear up some myths being floated about the obesity paradox.

Reporting research finding anything positive about fat is accompanied by disclaimers, caveats and every effort to minimize its significance. It’s even called an obesity paradox, perhaps hoping we’ll think it an anomaly, rather than where the strength of the evidence lies. You’ve probably caught the news stories about a Canadian study reportedly showing that people with “a few pounds,” who are “slightly overweight,” are carrying “a little extra weight,” have “excess pounds, but not too many,” and are “overweight but not obese” will “actually live longer than those of normal weight.” But that isn’t what this latest study found. It’s what the press release said it found.

What they did

This study, led by Heather M. Orpana, Ph.D., from Statistics Canada, set out to estimate the relationship between BMI and all-cause mortality in a nationally representative sample of Canadian adults, weighted to represent the total population of the ten Canadian provinces. The database they used to look for these correlations, using Cox proportional hazards computer modeling, was of 11,834 adults (25+ years old) who had participated in the National Population Health Survey in 1994-1995 conducted by Statistics Canada. The data was matched to the Canadian Deaths Database through 2005. During those 12 years of follow-up, 1,929 people had died. The authors adjusted for age, gender, smoking status, physical activity and alcohol consumption in their computer model. They didn’t factor in social and economic status.

Because the BMI data was self-reported, they also used a correction factor they had developed, which showed the same pattern of results. As they pointed out, self-reported height and weight “are considered valid for identifying relationships in epidemiological studies, with self-reported values being strongly correlated with measured values.”

What they found

The results of this epidemiological study were published in Obesity, the journal of the Obesity Society. This study found that none of the relative risks associated with mortality they examined were tenable [explained here], except for one. Age. At age 65, the relative risks of dying rose to 44.35 times compared to age 25; and by age 75, relative risks are 119-fold. We should stop right there, as tenable correlations are the only ones that deserve our focus. But that wouldn’t have made a news story, so what followed was splitting hairs among the rest.

Looking at corrected BMIs, according to the breakdowns adopted by the world’s governments, the authors found that compared to ‘normal’ BMIs (18.5 up to 25):

● being overweight (BMI 25 up to 30) was associated with a 25% lower risk of dying

● being obese (BMI 30 up to 35, which includes about 80% of all obese people) was associated with a 12% lower risk of dying.

● And the risks associated with the most ‘morbidly obese’ (BMIs 35+) — the uppermost 3% of this Canadian cohort— were statistically the same as those with ‘normal’ BMIs. [RR=1.09 (0.86-1.39, 95% CI) versus RR=1.0.]

Because physical activity could be a confounding factor, and also associated with age and health problems, they analyzed the data using models that excluded and included physical activity. Physical activity had no statistical effect on their findings.

They also analyzed the data to adjust for health by excluding the first four years of follow-up to account for possible reverse causation, where pre-existing illness and poor health could lead to lower BMI and earlier mortality. The results, again, were not statistically affected.

As the authors broke down the data into a multitude of variables looking to parse out correlations, the most significant relative risk they found was among underweight men (BMI less than 18.5) associated with a 2.5 relative risk of mortality, while higher weights were associated with no greater risks for men until those with the very highest BMIs — although the 72% risk was still untenable (attributable to random chance or confounding factors).

In contrast, the authors noted that among women, who comprise most of those at the uppermost extremes of obesity, even the most ‘obese’ (obesity class II and higher) was associated with no higher mortality risks, while being overweight and obese up to class II were associated with a 23%-19% lower risk.

Putting it into perspective: Rather than a population-wide weight problem, the vast majority of Canadians, according to the government’s Community Health Survey: Nutrition, have BMIs of 18.5 to 35. In other words, nearly every Canadian is at a "healthy weight" range — with no association to higher risks for death and even associated with lower risks. Far from a crisis of people at extremes of weight, only about 2% of Canadians have BMIs under 18.5 and 2.7% have BMIs 40+.

As Statistics Canada reports, overweight and obesity are most strongly correlated with rising age among the population. Countering another popular myth about fat people, its Community Health Survey found that 58.2% of overweight and obese Canadians are eating 5+ servings of fruits and vegetables a day, significantly higher than those of ‘normal’ weight.

The authors then reanalyzed the data by breaking the BMI ranges down into nine categories, and compared mortality risks to those in the upper half of the ‘normal’ range (BMI 22.5-<25). It was then obvious that being fat, whether overweight or obese, is mostly associated with a lower risk of death and that it doesn’t matter much how fat one is. [Remember, we’re still splitting hairs here.]

BMIs 27.5-<30, for example, were associated with a 13% lower risk, while BMIs 30-<32.5 were associated with a 8% higher risk, and BMIs of 32.5-<35 had an 8% lower mortality risk. There was no dose-response, lending additional strength to higher weights not being the actual cause for differences in mortality among people.

Risks rose steadily with BMIs under 22.5 (18% higher risk with BMIs 20-<22.5; 23% higher risk associated with BMIs 18.5-<20; and 89% higher mortality associated with BMIs under 18.5), yet there are no governments and industries devoted to massive public campaigns against slenderness.

The value of this study is that it is a null study, finding no strong association between overweight-obesity and mortality — meaning overweight-obesity itself can’t have a causal role in mortality. Blaming weight for differences in mortality isn’t scientifically supportable. But, like countless other null studies, how likely will this one be used to redirect massive programs and medical interventions and research into other directions with more fruitful potentials to help people?

Putting it into Perspective: This data from the Canadian government fails to support its vast obesity network of industry, stakeholder associations, government, obesity societies and other stakeholder interests in an imperative to enact a national policy to eradicate obesity. The Canadian Obesity Network (CON), supported by the government of Canada ($5.6 million NCE funding this year), said in its 2009 Progress Report that the “global health calamity” is emerging as a priority for researchers, health practitioners and policy makers,” adding:

It’s easy to see why the alarm bells are ringing. One in 10 premature deaths among Canadian adults aged 20–64 years is directly attributable to overweight and obesity. Notably, obesity is a significant risk factor for at least five of the top 10 leading causes of death in this country… As much work remains to be done for our vision to fully come to fruition for Canadians, this is also our call for increased government funding towards efforts to better understand the causes of obesity and identify effective treatments, as well as a call for a renewed commitment by all stakeholders who can and should play a role in that process. Solutions require urgent action on many levels, with broad stakeholder involvement matched by political will and grassroots community engagement.

Notice how correlations are made into causations and then used to support government action and medical interventions. Yet, other Statistics Canada data provides no support for claims of a population-wide health calamity, either. It has been reporting that life expectancy at birth among Canadians has been soaring steadily for the past century and has reached all-time highs. Just since 1980, for example, life expectancy among men has risen from 72 years to 77, and among women from 79 years to 82. According to Statistics Canada, age-adjusted mortality rates for all causes dropped 6 percent between 2001 and 2005, going from 6/1,000 to 5.63/1,000 of the population. Deaths from chronic diseases popularly associated with obesity are all dropping, too. Cancers down 4.7%, heart disease down 15%, cerebrovascular disease down 20% and diabetes down 1%. Even Statistics Canada acknowledged that it’s difficult to enumerate changes in obesity rates because of the differing methods that have been used to gather information on height and weight among Canadians.

What was reported they found

So, according to the authors' findings, compared to ‘normal’ BMIs, ‘overweight’ (BMI 25-<30) and ‘obese’ (BMI 30 up to 35, which includes about 80% of all obese people) are associated with a 25% to 12% lower risk of dying. And the risks associated with the ‘morbidly obese’ (BMIs 35+) are statistically the same as those with ‘normal’ BMIs. These findings coincide with other population studies we've examined.

We read a very different spin the media. It showed how afraid people are to be seen “excusing” obesity. The New York Times, for instance, reported:

Excess Pounds, but Not Too Many, May Lead to Longer Life

…The report, published online last week in the journal Obesity, found that overall, people who were overweight but not obese — defined as a body mass index of 25 to 29.9 — were actually less likely to die than people of normal weight, defined as a B.M.I. of 18.5 to 24.9…

False. The study found obesity (BMIs 30-<35) were also less likely to die than people of a “normal” weight, and that the highest BMIs had statistically the same mortality risks as “normal” weight people.

“Overweight may not be the problem we thought it was,” said Dr. David H. Feeny, a senior investigator at Kaiser Permanente Center for Health Research in Portland, Ore., and one of the authors of the study. “Overweight was protective.”

So was obesity. The relative risks for mortality associated with the corrected BMIs were 25% to 16% lower among the overweight and obese (BMI 30-<35), respectively, compared to “normal weight.” And the risks associated with the most “morbidly obese” — the highest 3% of the population — were effectively the same as those with “normal” BMIs (18.5-<25).

He said the finding may be due to the fact that a little excess weight is protective for the elderly, who are at greatest risk for dying…

While overweight was protective for people from age 60, associated with a 19% lower mortality risk, their data found that being obese (BMI 30-<35) was also protective. But, obesity (BMI 30-<35) was even more strongly associated with reduced mortality in younger adults (25-59 years of age) than among those 60 years and older (11% and 6%, respectively).

It is difficult for the public to realize that what seems intuitively correct about the dangers of being fat, and our diets and lifestyles, is not grounded in science, but in what is currently socially desirable, in vogue and what we hear EVERYWHERE we turn. Marketing and entertainment, packaged as news or information, however, is not science…regardless of the prestige or popularity of the source.

While, in reality, our body shapes and sizes are primarily the result of genetics and age, weight has long been a marker of social class, celebrity status, and an outward sign of adhering to advantageous ideologies. Once, fat was seen as healthful and desirable. There was no obesity paradox. Today, fat is out and thin is in. Even our celebrities keep getting thinner.

While fads and fashions may be entertaining and make some people loads of money, their danger comes when people believe they are much more than that. It can put lives and livelihoods at risk. People deserve public health policies and medical care based on sound evidence-based science, not beliefs or correlations. And changing the definition of “evidence-based” medicine to now mean computer modeling to identify correlations doesn’t count.

© 2009 Sandy Szwarc

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The Figure-Flaw Paradox: Does it really matter how your body measures up? Part 2

The “figure flaw paradox” is really a retake on the obesity paradox. As obesity has proven to be a poor measure of health or mortality risk, new renditions are being proposed. But the fallacies are the same.

We’ve encountered all sorts of spins trying to preserve the myths of the deadliness of fat — from claims that the studies only show a paradox with really old people to that being overweight might be okay but not obese — hoping we won’t actually read the studies to see that that’s not what they found. It’s unpopular to spread the news that most fat — most overweight, as well as most obese — people have lower risks for mortality than those with “healthy” weights; or that thin people, regardless of their age, fair the worst. Some discount the better outcomes among obese people by saying they get better healthcare than thinner people — something completely opposite of decades of documented discrimination against obese people in healthcare.

The suggestion we most hear trying to negate the obesity paradox is that BMI doesn’t differentiate fat (“bad”) from muscle (“good”), the assumption being that fat is bad. Increasingly trendy measurements to identify “unhealthy fat” have been proposed, including percentage body fat, waist circumference and waist-to-hip ratio (“belly fat”). Savvy readers could simply take all of the flawed studies and staticulations behind obesity and step and repeat for each new variation.

As with using weight or BMI, the same misuses of correlations in poorly controlled studies have been used to point to abdominal fat as a cause of ill health and higher mortality. Where our bodies store fat, as well as our body shapes and types, is largely genetically determined. But weight gain, especially in the mid-section, is a marker for age among the general population. Studies of populations consistently find that people who are heavier, especially in their mid-section, are older. [They’re also more apt to be yo-yo dieters and lower social class.] And age is the biggest risk for dying and diseases of old age. That’s why well-controlled and properly designed studies that remove biases such as these, are so important. A null study in epidemiology is most important to us. If a strong correlation can’t even be found, then that measurement can’t possibly be a credible cause for us to focus on.

Two independent* groups of researchers wanted to see if obesity or where fat is distributed on our bodies can predict our risks for premature death. They went to the most reliable and objective data available on Americans: actual measurements taken by specially-trained technicians on a large representative sample of the population and actual mortality data. The Third National Health and Nutrition Examination Survey (NHANES III, 1988–1994) conducted the most precise measurements of body size, measurements and composition available on a large representative sample of the U.S. population (including BMI; body fat percentage measured by bioelectrical impedance; skinfold thickness; circumferences of waist, hip and arm; waist-hip ratio; and waist-height ratio). National death certificate data in the national Death Index linked mortality data through 2000 to these detailed measurements in NHANES III.

We recently reviewed the findings from senior scientists at the National Center for Health Statistics at the Centers for Disease Control and Prevention (CDC) and the National Cancer Institute. In a nutshell, the data showed that no higher measurement of body shape or size, or body composition, is predictive of higher risks of dying from all causes, compared to people with “healthy” numbers and model figures. Nor was there a net benefit of using BMI versus another measurement. The data also found that NONE of the 21 diseases popularly attributed to obesity — those “obesity-related” diseases, including: cardiovascular disease, cancers (colon cancer, breast cancer, esophageal cancer, uterine cancer, ovarian cancer, kidney cancer, or pancreatic cancer) and diabetes or kidney disease — are actually associated with excess deaths at any BMI category, including obese.

Another group of researchers, led by professor Jared P. Reis, Ph.D., with Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland, used the same nationally representative data on adults aged 30 years and older, and applied different statistical modeling to investigate the associations between BM, body fat, and various body measurements to mortality. They approached it from a different perspective regarding hypotheses about causal relationships to obesity-related conditions, noting: “We did not adjust for physical activity or possible mediators of obesity effects, such as diabetes, hypertension, or high cholesterol, since doing so would have resulted in over adjustment because of their position on the causal pathway.”

Did they show the same null findings as the CDC scientists? It turns out “yes,” but you have to look closely to realize that.

Their data showed

Their findings, published in Obesity, the journal of the Obesity Society, weren’t widely published in mainstream media. And those who glanced only at the abstract missed the results demonstrated in the data itself.

First, not surprisingly, most predictive of mortality was age. The men and women who died during the 12 years of follow-up were significantly older (20.7 years older among the men and 21.3 years among women). Among the younger men (30-64 years), only 7.5% died over 12 years of follow-up compared to 48.5% of older men (65+ years); and only 4.9% of the younger women (30-64 years) died during those 12 years, compared to 36.76% of the older women.

In examining the risks associated with BMI and the various body measurements and ratios, they adjusted for baseline age, race/ethnicity, education, smoking status, alcohol use, heart disease, stroke, respiratory disease and cancer (except nonmelanoma skin cancer). Their findings revealed:

● Among younger men, there was no statistically significant correlation between BMI, waist circumference or waist-hip ratio and risks for death from all causes.

● Among older men, mortality risks were inversely associated with each measurement — risks of death were lower the higher the BMI and waist circumference — with the fattest men associated with a 30-40% lower mortality risk compared to those in the ‘normal’ range. Even the men with the highest waist-hip ratios were associated with nearly half the risk of death of lean men.

● Among the younger women, there was no statistical difference in BMIs or waist circumference and risks for dying. So few young women died in each quintile over the 12 years (0.4% a year in the national sample, 18 women), that looking at hazard ratios alone exaggerates perceptions of actual risks, anyway.

● Among the older women, BMI was inversely associated with mortality. The highest risk for death was among lean women with low BMIs. Fat women of all sizes were associated with lower risks. The most “obese” women with the highest BMIs had a 23% lower risk for mortality compared to “normal” weight women. There was no correlation between waist circumference or waist-hip ratios and the women’s risk for death, although all of the larger sizes had lower risks than thin women.

To limit potential confounding influence from existing or subclinical diseases, the authors also adjusted for “clinically manifest disease at baseline and excluded deaths within the first 5 years of follow-up” and the results were the same.

Do you see the grossly higher risks for death among obese people, according to their BMI, waist-hip ratio or waist-thigh ratio? If you can’t, it’s because they aren’t there, of course. The risks of adiposity have been exceedingly oversold to the public.

Abdominal fat, or central adiposity, has been a topic of frequent interest and some have suggested it be used rather than BMI to evaluate mortality, under the belief that unhealthy visceral fat is the underlying reason for morbidity and mortality associated with overall obesity, wrote Dr. Reis and colleagues. In their review of the literature, they noted that waist circumference has been more highly correlated with visceral fat than waist-hip ratio or waist-thigh ratio. However, studies to date have not consistently supported a correlation between abdominal fat or body fat distribution as predictive of mortality. Nor has waist circumference been consistently shown to be more strongly associated with type 2 diabetes, cardiovascular disease or mortality than waist-hip ratio, they said. “Therefore, it is clear that waist-hip ratio and waist-thigh ratio do not reflect variation in visceral fat accumulation,” they wrote. [We’ll look soon at the definitive clinical trial that disproved the visceral fat hypothesis.]

The only barely statistical correlation they found was waist-thigh ratio in young men and elderly women. While this may be of interest to those still selling those thigh masters made popular by Suzanne Somers, the notion of spot reducing our way to better health or longevity was debunked long ago. A biologically plausible explanation for continuing down the body to look at other measurements is so far removed from science — we’re sooo not going to go there. Of course, that hasn’t stopped people from marketing weight loss programs to treat “fat ankles” and surgeons even treating “toebesity” with surgery to slenderize generously-proportioned digits.

The belief in the unhealthiness of body fat is so ingrained that it can sadly lead anyone to be unable to grasp the reality of the evidence. Dr. Reis wrote that the findings in their study suggests “that it is not only important to have a low BMI but also a low amount of abdominal adiposity to lower your risk of death.” Dr. Reis and colleagues wrote in their concluding paragraph:

In conclusion, we provided evidence on the relative importance of well-defined measures of overall obesity and abdominal adiposity or body fat distribution in assessing risk of total and cardiovascular disease mortality in a nationally representative sample of US adults. Despite their limitations, ratio measures of body fat distribution were strongly and positively associated with risk of mortality in middle-aged adults. In addition, WHR and WTR increased prediction of mortality among normal weight and obese middle-aged adults. Among the elderly, a higher BMI in both sexes and WC in men were associated with a lower risk of mortality, while indicators of body fat distribution increased survival or did not influence risk of mortality. These results suggest that ratio measures of body fat distribution carry important information for identifying middle-aged adults at increased risk of mortality and therefore should not be abandoned in research or practice.

Are those the conclusions you would have reached after an objective examination of the findings? The importance of independently thinking and looking at what a study found, rather than taking abstracts and authors’ interpretations of the findings as the same thing, are especially evident when it comes to the obesity paradox.

© 2009 Sandy Szwarc

* In a private email from Dr. Reis, he indicated that they hadn't known that Dr. Katherine Flegal, Ph.D., and colleagues at the CDC had also examined body shapes, measurements and composition. “The major difference between our study and those of Katherine Flegal is that we added information regarding central obesity or body shape including waist circumference, waist-to-hip ratio and waist-to-thigh ratio,” he wrote.

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Real life evidence — government funded healthcare

Yesterday’s news provided updates on two healthcare stories we’ve been following, so here’s a quick update.

The Massachusetts Experiment

Readers will remember when Massachusetts signed the nation’s first state universal health insurance program into law. This program was to be the test ground to see how universal health coverage by the government would work here in the United States. “This is the healthcare plan seen by many as a model that could be replicated around the country,” the Boston Globe noted yesterday.

As is known, it made the purchase of state-approved health insurance mandatory for every resident, but within weeks of the law’s deadline for people to have purchased insurance, the state was scrambling. It hadn’t accurately budgeted for the program, and without enough doctors, 95% of doctors weren’t accepting more patients. Rationing of services, reductions in benefits and growing waits for care began. In efforts to keep the program solvent, Massachusetts cut payments to doctors and hospitals, reduced choices and benefits for patients, and was looking at increasing out of pocket expenses for patients.

By February of last year, the state was asking the Federal government and America’s taxpayers to bail it out and cover half of the program’s costs from 2009 through 2011. According to the Boston Globe, the program will cost taxpayers $1.35 billion annually by June 2011.

Yesterday, according to the Boston Globe, the near bankrupt Massachusetts healthcare program cut $115 million — 12 percent of its budget — from Commonwealth Care, which subsidies premiums for the poorest residents. The savings is planned to come from eliminating dental coverage for them; reducing enrollment of poor residents by no longer automatically enrolling those who forget to designate a health plan; and the bulk of the remaining “savings,” $32 million, will come from slowing payments to the managed-care health insurance companies with the plan. The board of the Connector Authority also dropped coverage for 28,000 legal immigrants beginning July 1^st.

“There’s no other place to go for money,” Lindsey Tucker, the organization’s healthcare reform manager, told the Globe. The Massachusetts Legislature just passed $1 billion in tax increases, in part trying to keep it afloat. State Treasurer Timothy P. Cahill came out strongly against the tax increases and proposed deep cuts in the state’s universal healthcare plan, calling it a luxury taxpayers can no longer afford, said the Boston Globe.

The plan had been sold to the public as helping to pay for itself by shifting more people into managed care. “We’re all still waiting for the savings,” Cahill said. “Universal healthcare was supposed to eventually save us money.” Instead, the Massachusetts Taxpayers Foundation, a business-funded group that had advocated for the healthcare law, has found that state spending on the healthcare plan has increased by about $88 million a year since it was implemented. Healthcare accounts for about a third of the state budget, although it is difficult to know precisely how much of that is attributed just to the state’s new healthplan.

“Nobody asked the tough questions. It was expensive, even in good times,” said Cahill. “In tough times, it just doesn’t seem doable… It’s a warning for the federal government as it looks to do something similar,” Cahill added.

The VA Example

The American Legion, which visits and inspects Veteran’s Administration health centers, reported that doctors at a facility in Pennsylvania gave 92 veterans incorrect radiation doses for treatment of prostate cancer, and that 53 veterans were possibly infected with hepatitis and HIV from unsterilized equipment at three VA health centers in Florida, Tennessee and Georgia.

At a hearing yesterday of the Senate Committee on Veterans Affairs, it was learned that staff from the Veteran’s Administration in Washington, DC, has been making unannounced visits to every VA health facility in the country and has found that fewer than half could provide any evidence of proper procedures and training for sterilizing of colonoscopy and endoscopy equipment, even after having received repeated alerts from the VA about the problem. The hearing revealed that improper sterilization had put more than 200 veterans at risk for HIV and hepatitis B infections after colonoscopies and other screening tests. As Associated Press reports, at the Senate hearing, it was learned that six patients have tested positive for HIV and 46 have tested positive for hepatitis after having colonoscopies or endoscopies.

More astounding, according to the Philadelphia Inquirer, soon after officials closed the prostate cancer program at the Philadelphia VA Medical Center for botching 92 out of 114 prostate cancer radiation treatments — in some cases causing grave injury by placing radioactive pellets in other organs and even giving too low of doses and/or unknown doses because they were “flying blind” because the equipment didn’t work — the medical center had been accredited by the Joint Commission, the main group that assures “quality” at our nation’s hospitals.

As we’ve covered, not only does the Veterans Administration offer insight into how well government-provided healthcare works in reality, the Veterans Administration has taken the lead on computerizing its entire medical record system throughout its 155 hospitals, 881 clinics, 135 nursing homes and 45 rehabilitation centers. It’s been held up as an example of the benefits possible with nationalized integrated health IT for reducing medical errors.

Continuing software glitches since August 2008 hadn’t been disclosed to the public until the Associated Press obtained internal documents under the Freedom of Information Act. These revealed that VA patients around the country have been being given the wrong doses of medications and exposed to medical errors due to electronic medical records, some of which might have been life-threatening.

As Fox News reported, veterans groups and lawmakers say that VA hospitals are underfunded and short staffed, leaving doctors overworked and largely unable to provide the best care, facilities and equipment are old and broken down, and the system is showing signs of an institutional breakdown. Joe Wilson, deputy director of the Veterans Affairs and Rehabilitation Commission for the American Legion, who testified before Congress, described disturbing problems.

This is how government-funded healthcare cares for our poorest citizens and those men and women who served our country. How well will it care for the rest of us?

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

Comparative effective research — what it means for us

This past week, when speaking to doctors about healthcare reform and the steps needed to reduce healthcare spending, the President answered a rhetorical question recently posed here about comparative effective research. JFS readers may find his answers interesting. His speech, however, didn’t receive widespread mainstream media coverage, at least in a form we would recognize. Before we look at what he said, it might be helpful to sort through some popular misconceptions about what comparative effectiveness research is and isn’t.

The American Recovery and Reinvestment Act (known as the stimulus package) expanded the Agency for Healthcare Research and Quality and increased its funding with $700 million for comparative clinical effectiveness research, with an additional $400 million to be allocated at the discretion of the Secretary of HHS. A new Federal Coordinating Council for Comparative Clinical Effectiveness Research was created to compare the merits of various competing medical treatments and strategies and make its recommendations to the Congress and Secretary of Health and Human Services about what medical interventions are effective, cost-effective and appropriate for the prevention, diagnosis and treatment of diseases and other health conditions.

That objective might sound rather benign: as if experts will be making sure our tax dollars are prioritized so they’ll go towards advancing health interventions that offer us the best quality of care.

But, that is not what it’s saying.

Reading comprehension

Follow along as we re-read what the text on pages 806-26 of the Stimulus Bill really says. The $1.1 billion funding will first encourage the adoption and use of electronic health registries and databases that the government can use to generate outcome data — in other words, to compile observational correlations, not to conduct randomized, controlled intervention trials that are the gold standards of evidence-based medicine. Note that electronic medical records are also included as a way to disseminate the government’s comparative effective research — that’s referring to those electronic prompts that tell healthcare professionals what tests, drugs and treatments they should order and records their performance.

The legislation says that about $1.2 million is to be given to the private organization, Institutes of Medicine, for it to recommend the national priorities that will be supported or funded by the government. The IOM Committee on Comparative Effectiveness Research Prioritization began work in March.* It held a meeting on March 19, largely closed to the public except for a presentation by the AHRQ and Congress, and invited stakeholders to present their requests on March 20^th. It will issue its final report this month (in little more than three months) — making its recommendations for what treatments and strategies will be supported, the IOM says, to enable “doctors and patients to make smart health decisions.”

The text of the stimulus bill goes on to specifically say that the funds must consider input from stakeholders and ensure the optimum coordination with research that’s supported or conducted by Federal agencies and departments. The Federal Coordinating Council will then consider this to make its final recommendations to the HHS Secretary and President. Yet, the members of the Council are all to be political appointees from senior management of each of those federal agencies responsible for the government’s health programs, appointed by the President and who work under the HHS Secretary.

Now, in reality, how likely will political appointees of Federal agencies, with huge programs and budgets under their control, and who are answerable to the President and HHS Secretary, be to recommend their programs be defunded or to go against the healthcare reforms outlined by the President and HHS Secretary?

Meaning and consequences

The ramifications are clear to medical professionals, even if they may not be to the public. The availability of health interventions that aren’t determined to be optimum, effective or consistent with national priorities will die from lack of funding. We might want to believe that this plan won’t interfere with the care that our individual doctors provide and that is will merely offer “information and guidance about best practices.” But doctors, who’ve had years of experience with Pay-for-Performance measures know the reality of third-party payer clinical guidelines.

They are concerned that their clinical judgment and knowledge about what care might be best for their individual patients, as well as consistent with the wishes of their patients, will be replaced by the determinations of a government agency. These aren’t clinical guidelines and recommendations for medical practitioners in their care of patients — instead, like other pay-for-performance measures, they will have the force of regulation and power of law in compelling compliance. Any healthcare professional whose practice fails to comply with what the government determines is effective, quality care will find himself uncompensated, as well as demoted as a “quality provider” and vulnerable to malpractice lawsuits. Doctors won’t, can’t, risk providing care outside the line — and insurers won’t cover care that isn’t government-approved — out of fear of liability or financial demise.

Understandably, medical researchers also won’t want to pursue costly research on innovative and potentially life-saving drugs, treatments and medical devices that aren’t in line with government supported programs. The dangers are evident: when government is given a greater role in determining what research is funded and what findings are endorsed and adopted, riskier research or research for rarer conditions or less politically popular issues could be jeopardized — and medical advancements could be held back.

History lessons

Experienced medical professionals also know the importance of anticipating the consequences of interventions that might sound good at the moment and of looking at what history and experience can teach us. They remember when Medicare was established as a Title XVIII amendment to the Social Security Act in 1965. It had promised consumers and medical professionals:

Sec. 1801. [42 U.S.C. 1395] Nothing in this title shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person.

Today, there are 153 P4P (“quality”) measures that Medicare lists as necessary, based on comparative effectiveness research. Doctors who don’t comply with these P4P measures, and who fail to use electronic medical records integrated with government databases, see their reimbursements cuts, receive bad quality ratings and find their patient referrals slashed. That is most certainly governmental supervision and control over the practice of medicine and the manner in which medical services are provided, isn’t it? Pay-for-performance measures are certainly governmental supervision or control over compensation of a person providing health services, isn’t it? The undeniable fact is that whoever pays calls the shots over the care we receive — not our doctors and not us.

Medicare recipients had also originally been assured that this program was voluntary and merely a safety net to cover major medical expenses for poor seniors and Congress had promised that the program (Section 1803) would not interfere with people’s ability to purchase private health insurance. Today, every senior who wants to receive the social security benefits they’ve paid into their entire working lives, is automatically enrolled into Medicare Part A. The only way to opt out of the government managed healthcare program and its mandatory government oversight is to sign away their monthly social security benefits. Did you know that?

More importantly, think about what is really being discussed here: putting the government in charge of deciding where limited healthcare dollars and resources will go; what therapies are appropriate for the government to pay for and not; and who gets life-saving drugs and medical care, and who should go without — this is inevitably making life-and-death decisions about how medical care should be rationed.

Other examples of comparative effective research in action

This effectiveness research model is similar to other programs used to establish government healthcare spending. In Britain, for example, the National Health Service uses the National Institute for Clinical Excellence (NICE) to determine which treatments it will offer. We would all like to believe that health care available to people would be free from influence by special interests or profit, and based on the soundest medical evidence. But as we’ve seen with the NICE guidelines, that isn’t what happens. Lots of things are supported and authorized by government committees that have failed to demonstrate that they improve health or clinical outcomes, reduce mortality, or reduce healthcare costs or hospitalizations; things that are even potentially harmful for significant numbers of people.

We’d also like to believe that human compassion and medical ethics would prohibit medical professionals from having to deny care to individual patients who are seen by the government as undeserving or not worth saving, or be forced to act in ways that may not be in the best interests of their individual patients. But last year when NICE released its Social Value Judgments, outlining its guiding principles for allocating National Health Services resources, the realities of the value of life versus the interests of the state and stakeholders were brought home.

Will you be denied knee replacement for a shattered knee because you are fat and “noncompliant” with the government’s weight loss advice? Will your grandmother, who could live another 20 active years, be denied a heart operation because she’s too old per government guidelines? Will a Down’s child be seen as a life not worth saving when he needs a life-saving surgery? Will you be denied medical care if you refuse to take statins, enroll in a weight loss program or get a mammogram the government says you must do?

It feels far more reassuring to believe that the government or a third-party payer will make the wisest, most evidence-based decisions about what health care is best for us and will take care of us, that we’ll all have access to the care we want, and that rationing will never happen. But that is not reality. There isn’t enough healthcare monies and resources. Cost-effectiveness analysis means looking at the most effective ways to divide a pot of money. It does not mean the inventions save healthcare costs, as is popularly believed, explained professor Louise B. Russell, Ph.D., at the Institute for Health, Health Care Policy and Aging Research at Rutgers University. Cost effective research means budgeting and making decisions about where to cut costs.

But will those very difficult decisions be made objectively, based on the best evidence, and grounded by medical ethics, or will they be politicized and money disproportionately going towards things with the most powerful lobbies and popular causes?

The evidence: government priorities

We don’t have to look at Britain to see how government comparative effective research will play out here and how politicians and government agencies prioritize healthcare spending. We already have an example right here at home.

The Oregon Legislature began the first and only project in our country to develop a policy for setting health care priorities for the state’s health plan. In 1989, it created the Health Services Commission to develop a prioritized list of health services ranked in order of importance to the entire population to be covered. The unpopular results were adjusted based on their relative importance as gauged by public input and the Commission’s judgment and individual condition/treatment criteria were prioritized according to their impact on health, comparative effectiveness, and (as a tie-breaker) cost.

“The resulting prioritized list is used by the Legislature to allocate funding for Medicaid and SCHIP,” according to the Oregon Health Services Commission. “The benefits based on the prioritized list are administered primarily through managed care plans, and approximately 1.5 million Oregonians have gained health coverage due to the expanded access made possible by explicitly prioritizing health services.”

Confusing health coverage with health care, and confusing quality with better health outcomes for people, misleads consumers every time.

The Commission’s prioritization report just released to the 75^th Oregon Legislature explains how government funding and oversight is irrevocably tied to compulsory clinical guidelines, those pay-for-performance measures, enforced through third party payer managed care plans:

As state resources continue to be stretched by competing demands, the Commission is constantly looking for ways to control costs to the Oregon Health Plan so that the largest number of people can be served. Practice guidelines are becoming an increasingly important mechanism in striving towards this goal. Sixteen new guidelines were developed over the past two years and seventeen previously existing guidelines were modified…

The first prioritized list of health services was released in 1993 and has been updated every two years, as part of the State’s budget process. The priority list for 2010-2011 is nearly identical to those currently in effect. Reading through the priority lists, you see a dramatic change in the conditions’ rankings over this decade. Life-saving medical care that used to be ranked high in 2000-2002 — such as head trauma, type 1 diabetes, peritonitis, acute kidney infection, pneumothorax and hemothorax, hernia and/or gangrene, etc. — has been shifted down. Meanwhile, interventions with poorer evidence for effectiveness or for reducing healthcare costs rank near the top, such as preventive services, substance abuse and smoking treatment, contraceptives and sterilization, obesity, and depression.

Interventions the government now prioritizes for funding and policy support are those of popular political causes and heavily lobbied financial interests, not those that are the most evidence-based.

For example, obesity treatment (including nutritional and lifestyle coaching) had been ranked at #645 in 2002. Today, obesity treatment ranks 8th. Chronic diseases of aging and conditions that most affect older and disabled people, such as chronic obstructive pulmonary disease (now ranking #305), cataracts (now #320), cirrhosis of liver (now #332), life threatening cardiac arrhythmias (now #303), knee surgeries (#448 and #618) and cancers have all been shifted significantly lower on the list. [It feels more palatable when people believe that diseases are victims' own fault and the result of failing to adopt healthy lifestyles. See how easily discrimination and eugenics can come to feel acceptable to a populace, especially when it rejects science?] Treating high cholesterol is ranked higher than appendicitis with abscess; intoxication is ranked higher than acute bacterial meningitis; dental cleanings is ranked more important than treating diabetic retinopathy, strokes or heart failure; treating attention deficit (ADHD) is ranked more important than treating cervical cancer, malaria or a ruptured spleen; and sleep apnea is higher than treating Parkinson’s Disease or a ruptured aortic aneurysm. And preventive wellness, smoking cessation and treating obesity is prioritized above all of these medical conditions — familiar stakeholder agendas, but offer little medical care when you need it, nor do they reduce medical costs.

Today’s preventive health strategies promote certain diet and lifestyle behaviors; as well as screenings, tests and treatments of health risk factors; with little credible evidence they improve outcomes for most people, no matter how intuitively correct they may sound. Prevention is not the slam dunk being marketed to consumers. More misleading, prevention, even disease management, has been sold to the public as a way to cut costs and has become the foundation of healthcare reform proposals. “If it costs $5,000 to save one year of life with smoking cessation programs, and $200,000 to save one year of life with statins, then we say smoking cessation is more cost effective than statins,” said Dr. Russell. “But neither one saves money.”

“We need to realize that prevention is not going to help reduce the growth of medical spending,” said Dr. Russell. “It’s touted as one [a panacea] but it is not. In fact, prevention has contributed to our rising medical costs.”

Most people don’t understand prevention or cost effective analysis, she explained. Prevention rarely saves money when studies examine actually costs. People don’t realize that studies claiming savings aren’t usually looking at medical costs and savings, she said. “You will see studies claiming that a preventive intervention saves five dollars for every one dollar spent,” she said. “What they are doing is valuing every life saved at the future earnings of the person and including those dollars along with medical costs and savings.”

Comparative effectiveness analysis means that the return on investment will always be lower among older people.

Comparative effectiveness analysis is not the same as evidence-based medical care, or that it’s been shown to be effective for improving the lives of people and reducing their risks of dying.

Comparative effectiveness analysis is not about reducing medical costs.

Back to that rhetorical question

Earlier this year, we asked if comparative effective research will mean the government will shut down its own programs, even though its own evidential reviews have shown them to be ineffective in improving health outcomes for people, reducing mortality or reducing healthcare costs —

● such as the CDC’s massive Division of Nutrition and Physical Activity and its war on obesity focused on diet and exercise

● such as the Centers for Medicare and Medicaid Services pay-for-performance measures

● such as preventive wellness and other alternative modalities

Or, is this not really about science and helping people, but about advancing ideologies and profiting stakeholders? Is the new Federal Coordinating Council for Comparative Clinical Effectiveness Research more about finding support for the government’s national healthcare reform agenda?

Here’s what the President said to doctors at the Annual Conference of the American Medical Association on June 15^th: [A Google Search tool on the right-hand sidebar is available to search by any issue if you need decoded information.]

Make no mistake: The cost of our health care is a threat to our economy. It's an escalating burden on our families and businesses. It's a ticking time bomb for the federal budget… So to say it as plainly as I can, health care is the single most important thing we can do for America's long-term fiscal health… How do we permanently bring down costs and make quality, affordable health care available to every single American? That's what I've come to talk about today. We know the moment is right for health care reform…

First, we need to upgrade our medical records by switching from a paper to an electronic system of record keeping. And we've already begun to do this with an investment we made as part of our Recovery Act…And that will not only mean less paper-pushing and lower administrative costs, saving taxpayers billions of dollars; it will also mean all of you physicians will have an easier time doing your jobs…It will prevent the wrong dosages from going to a patient. It will reduce medical errors, it's estimated, that lead to 100,000 lives lost unnecessarily in our hospitals every year.

No one stood up to show the President the medical literature disproving these claims.

The second step that we can all agree on is to invest more in preventive care so we can avoid illness and disease in the first place…It means quitting smoking. It means going in for that mammogram or colon cancer screening. It means going for a run or hitting the gym, and raising our children to step away from the video games and spend more time playing outside. It also means cutting down on all the junk food that's fueling an epidemic of obesity which puts far too many Americans, young and old, at greater risk of costly, chronic conditions…

Building a health care system that promotes prevention rather than just managing diseases will require all of us to do our parts. It will take doctors telling us what risk factors we should avoid and what preventive measures we should pursue. It will take employers following the example of places like Safeway that is rewarding workers for taking better care of their health while reducing health care costs in the process. If you're one of three-quarters of Safeway workers enrolled in their "Healthy Measures" program, you can get screened for problems like high cholesterol or high blood pressure. And if you score well, you can pay lower premiums; you get more money in your paycheck…

No one stood up to show the President the medical literature disproving these claims. Not one doctor explained risk factors or spoke out against discriminating against people based on numbers that are poor measures of anything but age, hereditary and social class.

Our federal government also has to step up its efforts to advance the cause of healthy living. Five of the costliest illnesses and conditions — cancer, cardiovascular disease, diabetes, lung disease, and strokes — can be prevented.

No one stood up to show the President the science disproving these beliefs.

Now, [reforming healthcare delivery] starts with reforming the way we compensate our providers — doctors and hospitals. We need to bundle payments so you aren't paid for every single treatment you offer a patient with a chronic condition like diabetes, but instead paid well for how you treat the overall disease… We need to give doctors bonuses for good health outcomes, so we're not promoting just more treatment, but better care…

With doctors paid more for treating healthier people with good numbers than older, sicker people with chronic diseases of aging, what do you think is going to happen?

So one thing we need to do is to figure out what works, and encourage rapid implementation of what works into your practices. That's why we're making a major investment in research to identify the best treatments for a variety of ailments and conditions… So replicating best practices, incentivizing excellence, closing cost disparities — any legislation sent to my desk that does not these — does not achieve these goals in my mind does not earn the title of reform.

So, will comparative effective research mean the government will shut down its own programs that have been found to be unsupported by the preponderance of sound evidence? Clearly not.

Politicians are not scientists and economists are not medical professionals, yet do we want politicians and economists making healthcare decisions for us and deciding what’s best? Will enough Americans see what is happening and where they are leading us?

© 2009 Sandy Szwarc

* The IOM’s Roundtable on Evidence-Based Medicine workshop entitled “Redesigning the Clinical Effectiveness Research Paradigm” was held on December 12-13, 2007. It offers an important glimpse at how what is considered evidence for the clinical effectiveness of drugs and medical interventions is being redefined, with stakeholders writing the script. As the published report of this Roundtable began:

In the face of this changing terrain, the IOM Roundtable on Evidence-Based Medicine has been convened to marshal senior national leadership from key sectors to explore a wholly different approach to the development and application of evidence for health care. Evidence-based medicine (EBM) emerged in the twentieth century as a methodology for improving care by emphasizing the integration of individual clinical expertise with the best available external evidence and serves as a necessary and valuable foundation for future progress. EBM has resulted in many advances in health care by highlighting the importance of a rigorous scientific base for practice and the important role of physician judgment in delivering individual patient care. However, the increased complexity of health care requires a deepened commitment by all stakeholders to develop a healthcare system engaged in producing the kinds of evidence needed at the point of care for the treatment of individual patients.

Chapter 2 “The Evolving Evidence Base” claimed that medical advancements of drugs and devices were happening too rapidly to make randomized clinical trials practical:

The latter emphasizes the need for improved statistical approaches and techniques to learn about the safety and effectiveness of medical device interventions in an efficient way… the utilization of Bayesian analysis to accelerate the approval process of medical devices…use of mathematical models is a promising approach to help answer clinical questions, particularly to fill the gaps in empirical evidence… Access to needed data will increase with the spread of electronic health records (EHRs) as long as person-specific data from existing trials are widely accessible…

To improve the specificity of treatment recommendations, Greenfield suggests that prevailing approaches to study design and data analysis in clinical research must change. The authors propose two major strategies to decrease the impact of HTE in clinical research: (1) the use of composite risk scores derived from multivariate models should be considered in both the design of a priori risk stratification groups and data analysis of clinical research studies; and (2) the full range of sources of HTE, many of which arise for members of the general population not eligible for trails, should be addressed by integrating the multiple existing phases of clinical research, both before and after an RCT.

The Roundtable went on to talk about the promising opportunities of genomics and pharmacogenetics and then “expanding sources of evidence, such as those related to the interoperability of electronic health records, expanding post-market surveillance and the use of registries, and mediating an appropriate balance between patient privacy and access to clinical data.”

IOM Roundtable Disclosures: “This project was supported by the contracts between the National Academy of Sciences and Agency for Healthcare Research and Quality, America’s Health Insurance Plans, AstraZeneca, Blue Shield of California Foundation, Burroughs Wellcome Fund, California Health Care Foundation, Centers for Medicare and Medicaid Services, Department of Veterans Affairs, Food and Drug Administration, Johnson & Johnson, sanofi-aventis, and Stryker.”

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

The importance of sound data — managing your healthcare costs

This week, Attorney General Andrew Cuomo announced that Health Net, Inc., a managed care company covering more than two million Californians and nearly a quarter million New Yorkers, had agreed to end its relationship with Ingenix and pay $1.6 million towards the creation of an independent database. This was Cuomo’s twelfth settlement against a network of health insurers across the country (including Aetna, MVP Health Care, Cigna, Wellpoint and Excellus Health Plan) using the Ingenix database, which he charged was a “conflict-of-interest-ridden system” with manipulated data and behind industry-wide consumer fraud and corrupt out-of-network reimbursement schemes.

Ingenix is owned by one of the nation’s largest insurers, UnitedHealth Group, Inc., and used by the nation’s largest managed care companies to determine reimbursement policies. Ingenix ran afoul of the Federal Trade Commission, which issued consent orders (Docket No. C-4214) against Milliman, Inc. and Ingenix, Inc. for engaging in “unfair and deceptive acts and practices.” Cuomo said Ingenix was “a conduit for rigged data” for the country’s largest third party payers, private and federal health plans and has intentionally skewed healthcare costs to bilk millions of consumers with higher out-of-pocket insurance bills and short change medical providers for expenses claimed to be over “usual and customary costs.”

Earlier this year, UnitedHealth Group had agreed to shut down Ingenix and pay $50 million towards creating an independent database, along with $350 million in class-action lawsuits.

But this story has far greater significance than is being recognized. It’s much bigger than insurance reimbursements and care management. The Ingenix database has also been used in medical research reaching spurious conclusions and supporting medical interventions, as well as public policies and healthcare reform calling for third-party payer oversight, that consistently benefit sponsoring stakeholder interests. Preserving the integrity of medical research has critical importance for the healthcare we receive and affects the lives and welfare of each one of us. The potential misuse of research to sell anything — including political agendas, healthcare reform or medical interventions — should concern everyone.

Ingenix, which says it’s a leader in health information solutions, also sells electronic medical records, and its consulting clients include more than 300 national and regional and Medicaid/Medicare managed health plans; more than 100 federal and state government agencies, and more than 50 healthcare delivery systems, including pharmacy benefit managers (PBMs). Ingenix benefited by the stimulus package, with the government making the adoption of national electronic medical records and preventive wellness programs key parts of organized efforts towards healthcare reform. Tom Daschle — former Senate Majority Leader and the President’s originally designated Health and Human Services Secretary and designer of the administration’s healthcare reform — was a special policy advisor, personally representing UnitedHealth Group, and keynote speaker for Ingenix.

Most importantly, Ingenix data has been used in published medical research — albeit terribly flawed — to convince Americans of skyrocketing costs of obesity, diabetes, depression, high blood pressure, high cholesterol and unhealthy lifestyles.

● The database was used, for instance, in a recent study (covered here) that claimed that bariatric surgeries save healthcare costs and has been used to coerce private and government payers to cover the surgeries. Will this flawed research be retracted and coverage for these surgeries be withdrawn? Not likely. A search of the American Journal of Managed Care, where the research was published, finds no retraction of the study or mention that its claims were based on discredited data.

● The database was used in a recently published study in Population Health Management commissioned by the National Changing Diabetes® Program, a lobbying organization of Novo Nordisk, Inc., to claim that undiagnosed diabetes cost the United States $18 billion in 2007 and that diabetes and pre-diabetes had cost the country about $218 billion in higher medical costs and lost productivity. This study remains prominent on the homepage of the organization’s website, with no mention it was based on discredited data.

● In fact, this database has been used in comparative effectiveness research of nearly every Pay-for-Performance measure (called “quality” measures); of electronic medical records; and of disease management, employer wellness and preventive health programs, claiming “to contain rising medical costs.”

● It’s been used in claims that compliance with P4P measures — for treating obesity, hypertension, hyperlipidemia, diabetes, depression, etc. — are “evidence-based medicine” and save healthcare costs.

● It’s been used to convince the public that managed care, electronic medical records, preventive wellness and fitness, employer wellness programs and compliance with health indices save healthcare costs and that noncompliance is costing everyone.

Credible scientists knew the studies weren’t convincing, even before hearing that the Ingenix data used was faulty. But, sadly, a lot of people readily believe the claims from anything said to come from a study or research, don’t realize that all studies are not created equal, and don’t examine the studies for themselves or recognize those that were never designed to be fair tests of anything to begin with.

If understanding the differing types of studies and clinical trials feels too overwhelming, here’s a helpful rule of thumb: Anytime you hear claims of body counts — a condition or behavior kills some huge number of people a year — or price tags — a condition or behavior costs society some huge amount in healthcare costs — you’re seeing statistical manipulations based on associations (attributable risk fractions calculated from relative risks and turning them into causations). Cost estimates are most used to sell a crisis, point blame on socially undesirable lifestyles or physical features, and convince the public of the need to “do something”... under the guise of public health and the common good.

If you’ve examined the various “costs of obesity” studies purportedly showing skyrocketing healthcare costs associated with obesity, for example, you’ve caught things like:

● failing to account for age or socioeconomic status;

● tallying any condition that’s ever been “associated” with obesity, and even others that aren’t (like dental services and eye glasses);

● double counting of the same conditions (with the same health risk factor used as the “cause” for as many as four different “obesity-related” diseases);

● incorrectly defining obesity to overstate the numbers of people crossing the threshold of “too fat”;

● piling on fallacious estimates of lost productivity and work hours;

● citing high healthcare costs among fat people, while failing to reveal they were lower than thin people;

● not factoring for the costs of weight loss pills, extra tests and interventions imposed on fat people and on children in mandatory obesity guidelines;

● blaming fat people for the adverse effects of weight loss treatments imposed on them;

● claiming fat workers cost employers more but failing to control for age, hours worked, and type of manual labor (which would reveal that fat workers actually file fewer worker’s comp claims per hour worked, have lower rates of lost workdays and lower medical claim costs than the general population of employees);

● and failing to reveal that healthcare costs aren’t rising in numbers of cases being treated as much as rising costs per treatment — 70% of costs due to more expensive drugs and technological interventions.

No matter how well conducted a study might be, however, when the data used is false or faulty, then the conclusions reached are unsupportable. Yet, how likely will the Ingenix scandal lead to calls for re-evaluating the premises behind healthcare reform with its managed care and third party oversight and interventions to reduce the costs of obesity, diabetes, depression, high blood pressure, high cholesterol and unhealthy lifestyles?

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

Paradoxes compel us to think — Part Two

Paradoxes Part One here.

Continuing with paradoxical correlations recently published in medical journals that we didn’t hear about, comes an analysis of the Helsinki Businessmen Study. As the authors noted, ‘obese’ or ‘overweight’ is associated in the medical literature with a better prognosis and lower death rates compared with ‘normal’ weight people, especially as people get older. They set out to see if losing or gaining weight during one’s adult life, or if traditional cardiac risk factors in middle-age, could potentially explain the obesity paradox. The authors reported finding that being overweight or losing weight in midlife had the worst prognosis and greatest risk of dying later in life.

Did you catch what they didn’t say?

Who had the best prognosis and lowest mortality risk? Those who gained weight and became fat.

This study offers some valuable take-home lessons, such as the importance for us to examine what a study’s data actually showed, to understand correlations and to read critically to get the full story.

Overview

Briefly, the Helsinki Businessmen Study cohort offered a valuable opportunity to test the obesity paradox because the men were similar in social and economic status, age, healthcare access and other factors that confound health and mortality outcomes. They were all healthy business executives who had participated in comprehensive medical check-ups during the 1960s and early 1970s at the Institute of Occupational Health in Helsinki. The study database had information on their BMIs and cardiovascular risk factors at multiple times during their lives, from the age of 25 through an average age of 73 years. The men who survived to the year 2000 were surveyed again to determine their BMI and health, and although self-reported, these health surveys had been validated in the Finnish population. The few men lost in follow-up were not different from the rest of the men by any measure examined. Mortality data was known on all the men because Finnish citizens are registered with the Population Information System, which keeps health and cause of death information.

The authors, led by Professor Timo Strandberg at the Institute of Health Sciences/Geriatrics at the University of Oulu, Finland, set out to explain the obesity paradox. They divided the men into those whose BMIs had remained in the ‘normal’ weight range and those who were fat (BMI >25) at each point in their lives that they’d been recorded, those who had been normal weight in 1974 but became fat later in life, and those who’d been fat in 1974 but lost weight and achieved a normal weight. Their results were published in the European Heart Journal.

How well did the traditional cardiac risk factors — health indices that included BMI, blood lipids (cholesterol), blood glucose and blood pressure; smoking habits and exercise — actually predict mortality and those men who went on to develop chronic diseases? Not surprising to regular JFS readers, regardless of the traditional cardiac risk factors, there was no statistical difference among those who went on to develop coronary heart disease, peripheral artery disease, cancer, pulmonary disease or dementia.

The only statistically significant inverse correlations to the men’s BMIs were with diabetes and hypertension — but they didn’t affect the men’s mortality rates, perhaps because, as we’ve seen, heavier people with both conditions have lower health complications compared to slender people with those conditions. Other popular myths weren’t supported in this study, which also won’t surprise regular readers who’ve followed the research. The men who gained weight as they aged and those who lost weight to achieve a normal weight had identical rates of developing diabetes, and the same cholesterol levels and blood pressures, as they aged.

Consistently overweight men made up the largest group of men who survived to the year 2000 (44% versus 30% of those who’d maintained normal weights). And, despite reports that the consistently overweight men had the worst prognosis, in follow-up through 2006, they actually had no statistical difference in mortality (HR=1.1 with confidence level 0.7-1.6) compared to the naturally normal weight men (HR=1.0).

But by every statistical analysis the authors attempted — including adjusting for potential confounding factors that included age, smoking status, and chronic diseases of aging (cancer, diabetes, dementia, cerebrovascular disorders, heart disease and heart failure, pulmonary disease, musculoskeletal disease and hypertension) — the men who’d been overweight but lost weight during middle adulthood to reach normal weights had about two times the risk of death compared to normal weight men or the men who’d just stayed fat. The risks steadily rose regardless of the years followed through 2006.

In comparison, the men who had gained weight during adulthood (gaining an average of 17.6 pounds from age 25, with about 15 pounds gained during middle age from around age 47) had the lowest mortality rates: 30 percent lower than the men who’d maintained normal or overweight status. While this hazard ratio isn’t tenable, as we know, gaining weight with age certainly isn’t the death sentence popularly believed.

Beliefs in the deadliness of weight gain and “middle-age spread,” and beliefs in the health benefits of watching your weight and losing weight, were not supported in this study. Even the authors appeared to struggle to interpret their own findings. These seeming paradoxes, though, weren’t paradoxes to obesity researchers. But decades of medical research which contradicts these popularized beliefs rarely reaches the public and their value as null studies was lost. Looking at just a few of those studies may give you an idea of how much inconvenient research never finds its way to consumers.

Mortality and weight loss

Beliefs about weight loss have become so widespread, few people stop to question if its benefits have ever been proven or, worse, if it could place people at greater risks for harm. Yet the potential health dangers of voluntary weight loss have been recognized among medical researchers for decades.

It goes beyond the recognized failures and side effects of weight loss prescriptions in nutritional shortfalls; diminished concentration, mental acuity, learning and productivity; cardiac arrhythmias; osteoporosis; heightened stigma of fat people; and eating disorders. The physiological and emotional changes that occur with chronic food restriction and restrained eating, as in eating disorders, for example, are similar to those experienced by starving people but are seldom understood as symptoms of hunger. The side effects of weight loss efforts, especially those begun at young ages, go beyond the effects on people’s lives, teaching generations to fear and have dysfunctional relationships with food and their natural bodies and appetites until many don’t know what normal eating is anymore.

The risks are downplayed and perceived to be warranted because, it’s believed, weight loss and maintaining normal weight is achievable and reduces mortality and prevents chronic diseases of aging — despite the fact that even the U.S. Preventive Services Task Force found little credible support for weight loss as having positive effects on overall mortality, mental health or daily functioning.

In 1992, the National Institutes of Health held what is still the most pivotal conference on Methods for Voluntary Weight Loss and Control, when experts reviewed nearly half a century of evidence on voluntary weight loss. It found that most studies, and the strongest evidence, showed voluntary weight loss regardless of the method, although seemingly to reduce risk factors, was strongly associated with increased rates of actual clinical outcomes including heart disease, stroke, type 2 diabetes and cancers, as well as increased rates for premature death — by as much as several hundred percent in some studies.

Time and again in randomized clinical trials of pharmaceuticals and other medical interventions, we’ve seen the importance of examining confirmed clinical endpoints — with all-cause mortality the most important — rather than surrogate endpoints. Not understanding risk factors and believing that these surrogate health indices are measures of health and future disease has been the greatest way the public been led to believe that weight loss is beneficial, even when it’s not supported in well controlled studies looking at actual clinical outcomes and mortality. With fasting, starvation/dieting and weight loss, most indices (blood sugar, cholesterol, blood pressure, weight, etc) temporarily drop and can be used to claim the short-term health benefits of dieting and weight loss — before they rebound, often to higher levels over the long-term.

German epidemiologists, examining 13,362 middle-aged adult men and women in the European Prospective Investigation into Cancer and Nutrition-Potsdam Study, for example, found that fat people who had normal blood pressures prior to weight loss had a nearly 7-fold increased risk of developing essential hypertension during the following two years after weight loss, and those whose weight yo-yoed had a 4.29-fold increase in hypertension.

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

In a later review published in a 1993 issue of the Annals of Internal Medicine, Dr. Andres and colleagues summarized the findings of 13 international studies on prolonged voluntary weight loss and mortality among adults who had been followed for eight or more years. The studies they included had made every effort to eliminate potential confounding influences of involuntary weight loss, which is generally seen as an important symptom of serious illness. For example, clinical exams were conducted at the end of weight loss to identify and exclude those with identifiable illnesses. They also applied a “temporal separation” period, excluding several years at the beginning of their analysis to eliminate people who may have had undetected illness at the time of enrollment. Ten of the 13 studies had factored for the effects of smoking, which is commonly associated with both lower weight and higher mortality. They noted, however, that: “Studies that have accounted for smoking habits have generally failed to show any significant effects of smoking on the association between weight change and death.”

The predominance of the research they examined showed that modest to moderate weight loss is associated with high mortality compared to those with no significant weight change or who gained weight. [The only study which hadn’t found high mortality was the Dutch Longitudinal Study (Deeg etal), conducted between 1955 and 1957. It was the smallest and had only reported longevity in terms of probabilities and found no statistically significant.] The preponderance of studies, eleven in all, found weight gain was associated with the lowest all-cause mortality.

Dr. Andres and colleagues concluded:

The current analysis of 13 studies of weight change now provides support for the concept that some degree of weight gain during adulthood is associated with lower all-cause mortality rates. The results of these analyses show that persons who gain some weight during adulthood survive longer, on average, than do those who maintain or lose weight and that long-term weight loss, even of a mild or moderate degree, is generally associated with high mortality rate.

The later Cardiovascular Health Study was a longitudinal observational study of 4,714 seniors, aged 65 years and older, sponsored by the National Heart, Lung, and Blood Institute. Participants were recruited from random samples of Medicare eligibility lists in four U.S. communities and their weights were measured at least five times between 1992 and 1999. The authors assessed the effects of weight change on mortality over another seven years of follow-up. After adjusting for confounding factors, such as illnesses, cancer, diabetes and overall health status, age, smoking, hospitalization, education, death of a spouse, disability, strength and gait speed, they found that even modest weight loss of just 5 percent or more was associated with an 82 percent higher risk of mortality, with those who were the slimmest at the beginning of the study had the highest mortality. Those whose weights yo-yoed were associated with a 2.2-fold higher risk for death compared to those with stable weights or who gained weight.

Studies have found similar results among adults of all ages. A study examining mortality among a nationally representative sample of the United States population — people who had had their weights measured as part of NHANES I — for example, failed to support the benefits of weight loss for fat people. Even after controlling for pre-existing disease, health and disability, weight fluctuations were associated with an 83 percent higher mortality risk. Among those who lost weight, mortality was 3.36-fold higher compared with those who stayed obese.

Obesity researchers have been questioning the long-term benefits on weight loss in the medical literature for decades, but these discussions — along with the null and negative studies — seldom get through the weight loss marketing to reach the general public. For example, in a 1999 issue of the International Journal of Obesity, Dr. Thorkild Sorensen with the Danish Epidemiological Science Centre at the Institute of Preventive Medicine in Copenhagen, Denmark, argued that sustained weight loss may not lead to decreased mortality and morbidity. Dr. Sorensen noted that major risk factors improve immediately during weight loss, but said that the reason to doubt the long-term benefits of weight loss is that “several epidemiological studies have been unable to demonstrate that long-term weight loss is followed by reduced mortality.” “To the contrary,” he said, “some studies suggest that weight loss is associated with increased mortality relative to the mortality associated with stable weight, and even that associated with stable overweight.”

The tempting explanation to explain away these findings has been that diseases associated with increased mortality cause unintentional weight loss. Another frequently proposed assertion is that those who lose weight have taken up adverse lifestyles, such as smoking or drinking. “However, in very carefully controlled population-based prospective studies, in which smoking, as well we preexisting and incident diseases, is taken into account, an increased mortality associated with weight loss remains,” he said. “Meta-analysis of long term results of weight loss indicate that after five years about 97 percent of subjects losing weight have regained that weight or even exceeded pre-treatment levels.”

It’s been argued, he summarized, that weight loss does not equal improvement in health and longevity, that staying fat is safer than weight fluctuations, and dieting has negative psychological effects. “In summary, we still do not have conclusive evidence that weight loss has overall beneficial effects.”

These researchers at the Danish Epidemiology Science Centre also investigated the effects on mortality of intentional weight loss alone. They examined mortality of nearly 3,000 fat people without pre-existing or current diseases who reported they had been trying to lose weight. The authors even controlled for behavioral and psychological risk factors and hypertension as potential confounding factors. Interestingly, those who were successful at weight loss had 86 percent increased risks of mortality compared to those who weren’t trying to lose weight and whose weight remained stable. While those who gained weight were associated with a 7 percent lower risk of mortality. Unintentional changes in weight — regardless of down and up, (which is rarely recognized as a symptom of disease rather than lifestyle) — were associated with higher risks. While none of the correlations were tenable or proof of causation, they did lead the authors to conclude that “deliberate weight loss in overweight individuals without known co-morbidities may be hazardous in the long term.”

Another valuable aspect of the study by Dr. Strandberg and colleagues was that it examined a group of men of similar occupational and economic status. Carefully controlled studies try to account for known influences on health and mortality — such as age and pre-existing disease. Epidemiological studies that claim to find associations between weight changes and mortality often poorly control for social class and economic status. Yet social standing and economic status have each been independently found to be strongly tied with health disparities. As regular JFS readers have seen, for instance, people living in socially disadvantaged settings and who experience social stigma have significantly higher rates of heart disease, diabetes and premature deaths compared to middle-incomes, even controlling for age, education, gender, healthcare access, cardiac risk factors (smoking, weight, blood pressure, blood cholesterol levels, etc.), diets and lifestyles .

Weight gain can be a marker of lower social class and economic status, yet weight is then inappropriately blamed for the poorer health and mortality. Popular beliefs and prejudices lead many to assume that poor people must be eating more, not be as physically active or eating unhealthy foods to explain their higher weight gains and mortality. But these prejudicial beliefs have not held up in the scientific literature.

A study of the European Prospective Investigation into Cancer and Nutrition—Norfolk cohort, for example, looked at data from medical examinations and lifestyle assessments that had been done on 14,619 healthy adults in 1993-7 and again during 1998-2000. People in low socioeconomic status gained more weight during middle-age — but the weight changes were unrelated to the calories they consumed or their activity levels, even after controlling for other traditional obesity risk factors.

Classism and prejudices have popularized beliefs, even among fat people, that lower-income people don’t know how to eat properly or how to feed their children and are eating mostly junk. If they ate “right” — i.e. more fresh fruits and vegetables — they would be healthier (and thinner), so the thinking goes. Besides the fact that the body of evidence consistently shows that fat and thin eat no differently to explain the diversities of their sizes, income doesn’t explain the diversities of their nutritional status, either. Population dietary studies published for well over 50 years have shown that in developed countries, low income children and families don’t eat appreciably different nutrients from higher income families.

A review of 196 published epidemiological studies examining diet quality and socioeconomic status in industrialized societies, for example, found that while people eat foods of different pedigrees, there is little biologically meaningful difference in total calories, fats, milk, protein, fruits and vegetables, or macronutrient compositions in the diets of people of differing socioeconomic status. The authors cautioned that poorly controlled studies, purportedly finding poorer nutrition among low socioeconomic groups, typically focus on at-risk groups and are not reflective of the general population. The recently published Low Income Diet and Nutrition Survey (LIDNS) of low-income families in the UK, monitored by the National Diet and Nutrition Survey (NDNS) programme, also found little difference in overall nutrients consumed among socioeconomic groups. This nationally representative survey of 3,728 of the most deprived households in the UK and is the most comprehensive medical exams and dietary analyses of its kind.

Mortality and weight gain

While decades of epidemiological and clinical studies have failed to support popular beliefs in the health benefits of weight loss, these beliefs continue unquestioned by the general public— few hear the evidence that could help them question their assumptions. Similarly, the fact that the natural weight gain that comes with aging might be healthful is just as unthinkable to consumers. Yet, as this study by Dr. Strandberg and colleagues found, weight gain in adulthood has been shown to reduce mortality in countless well-controlled studies the public never hears about.

The Honolulu Heart Program is just one of those reporting this paradox. It followed 6,537 middle-age Japanese American men over six years and after adjusting for age, smoking status, alcohol consumption, physical activity, socioeconomic status, caloric intake and preexisting disease, all-cause mortality was statistically higher among those who lost as little as 2.6 kg, while lower among those who gained 2.5 kg or more.

The adult years are characterized by a gradual and persistent physiologic increase in body weight, leading researchers to suggest that this age-related natural phenomenon may be protective and a major force in human longevity. The typical American adult gains 3–5 kg per decade beyond the age of 20 years, which translates into about 10–15 kg [22-33 pounds] between the third to fifth decades. The clinical research of Dr. Andres found that the fewest deaths occurred in those whose weights increased as they aged. Given the protective, fertility, immunological and nurturing benefits of fat stores, it is not surprising that the preponderance of medical research has failed to support beliefs that midlife weight gain is harmful to healthy women and men. With age, fat cells have also been shown to become less metabolically active, lessening their role in diseases associated with aging like diabetes.

“It’s acceptable, possibly even highly beneficial, for normal, healthy adults to gain gradually about a pound a year beginning around age 40,” said Dr. Andres in Food & Nutrition Digest, “so that by the time they’re in their 60s they weigh about 20 pounds more than the Met Life tables would suggest.”

The possible healthfulness of natural weight gain with aging, however, is a paradoxical idea in popular media. People may never think to question their beliefs about the deadliness of fat and benefits of weight loss when they never hear anything different.

The importance of research finding seeming paradoxes is that it make us think, question and not be afraid to learn where the evidence might really take us.

© 2009 Sandy Szwarc

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Cardiologist writes his patients

It's a shame that too few consumers understand what medical professionals do about what’s coming and being planned for them in healthcare reform and the woo that is today’s preventive health movement. Dr. Westby G. Fisher, M.D., a board certified internist, cardiologist and cardiac electrophysiologist at NorthShore University HealthSystem and Associate Professor of Medicine at the Feinberg School of Medicine at Northwestern University in Evanston, Illinois, writes a satirical letter to his patients, advising them to stay healthy!

Dear Mr. and Ms. Patient,

It has come to my attention that in order for your to enjoy success as patients in the new era of health care reform, you must start working now to prevent illnesses that might befall you. Do not, under any circumstances, eat or drink too much. Fast food might as well be considered illegal. Exercise three, four, five times a day, even if it means take time off from work. It goes without saying that you should not smoke. The government has data that demonstrates how you have become fat, lazy, and a huge burden on our health care system. Your non-compliance threatens the very fiber of our economy. Even employers realize this, and are using calculators to figure your financial burden to them.

Now, in the unfortunate circumstance where you might become sick, you will need to develop symptoms that follow a few simple rules….

Read the rest here.

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Sensation makes headlining news but not good science

The award for the most sensational swine flu story goes to The Age. The number of swine flu victims in Australia was overstated by 5,500–fold.

Today’s news headlined: “One-third of Victorians may have flu.” According to the story, “up to one-third of Victorians could now be infected with swine flu, an expert said yesterday, as the Federal Government announced it was preparing to ramp up its response to the virus in coming days.” Last night, Health Minister Nicola Roxon was reported as saying that the total number of people in Australia infected with the swine flu had hit 1,515.

Fact check: This equals about 0.006% of the Australian population — the Australian population was 21,814,135 people as of June 15, 2009, 12:26am, according to the Australia Bureau of Statistics.

Health surveillance finding about 0.006% of the Australian population infected with swine flu is a far cry from one in three, 33.33%, as is being claimed. Even if every single case of swine flu in Australia came from Victoria, that would only represent 0.028% of the Victorian population (5,364,800 people per Australia Bureau of Statistics).

Who were the experts suggesting that one-third of the Victorian population could now have swine flu? The Age reported:

Professor Greg Tannock, a virologist from the Burnet Institute, said that although it was difficult to estimate, up to one in three people could have picked up the virus by now. "I think one in three is a reasonable estimate, but that's based on sheer gut feeling rather than anything else. We need hard data," he said.

President of the Australian Medical Association Victoria, Dr Harry Hemley, said doctors had been inundated with people suffering respiratory infections, including whooping cough and influenza that could be the H1N1 virus, in recent weeks. "I would say about one-third of the population has some sort of upper respiratory infection right now, but I can't say how many of those have swine flu," he said.

More frightening than the swine flu is the fact medical experts would fall for the Land of Incognita fallacy. Reports of more flu-like symptoms being seen at clinics and emergency rooms is an indication of swine flu panic, not actual disease. Nor has there been any death from swine flu reported in Australia, according to the World Health Organization.

But Health Minister Roxon also repeated another faulty statistic, linking obesity to a greater risk for swine flu. The source of the claim that obesity is a risk factor for swine flu is the May 22^nd CDC Morbidity and Mortality Weekly Report about hospitalized cases of H1N1 seen in California from April to May. The MMWR report was released online on May 18^th and was covered in a widely syndicated article in the Washington Post titled: “Survey Finds Link Between Obesity and Flu Severity.” According to the newspaper, the CDC report suggested that obesity could be as much of a risk factor for serious complications from the flu as diabetes, heart disease and pregnancy.

“We were surprised by the frequency of obesity among the severe cases that we've been tracking,” CDC epidemiologist Dr. Anne Schuchat was quoted as saying. The Washington Post said scientists are “looking into the possibility that obese people should be at the head of the line along with other high-risk groups if a swine flu vaccine becomes available.”

The claim that obesity is a risk factor for swine flu has since spread around the world in more than 816,000 stories over the past month. News stories are reporting that obesity is one of the conditions that puts people at greater risk.

We can’t count on newspaper journalists or even medical experts and government officials to do much in the way of fact checking or to clarify the information. Going to the original source finds that the CDC had actually reported that four out of the 30 patients hospitalized in California for H1N1 had been obese — that’s 13%. According to the CDC National Center for Health Statistic, 34% of Americans are obese — which means fat people are decidedly under-represented among those hospitalized for the flu. Obesity would appear protective.

Looking more closely at the CDC report finds that most hospitalized cases occurred in people with other health problems. Among those obese patients were: two asthmatics (a 7 year old and a 40 year old who also had hypertension), a 30 year old diabetic, and a 41 year old patient with autoimmune hepatitis/biliary cirrhosis and liver transplant who was also hypertensive. The text of the report also described an 87 year old woman with multiple medical problems, including breast cancer with possible abdominal metastasis, hypertension, diabetes mellitus, coronary artery disease, cerebrovascular disease, chronic renal insufficiency… and obesity.

The obesity link has taken on a life of its own because few people understand what risk factor means. As we know, it means nothing more than that a correlation was found. Risk factor is not the same thing as a risk. But the correlation with obesity led many people to believe that obesity has a causal role and increases the risks of swine flu. And another obesity scare is born.

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Paradoxes — Compel us to think

We may know, intellectually, that correlations can never show causation, but when a correlation seems to confirm a reason we believe, it’s very easy to find ourselves falling for the fallacy, anyway, and to not even consider other explanations. We may call our belief “common sense” or what “everyone knows,” without realizing that we’ve come to believe it simply because it’s all we ever hear. It may never even occur to us to question an axiom — especially if we never hear about the evidence which contradicts or disproves it. The obesity paradox wouldn’t be a paradox at all, for example, if the public had been hearing objective reports of medical research all along.

The next four posts will share with you four recently published studies in peer-reviewed medical journals that the media ignored. Like countless other studies that the public never hears about, these articles probably didn’t come with press releases because there was nothing to sell you or to promote. In JFS’s objective to help you get a fuller story and to encourage all of us to think critically and for ourselves*, we’ll share these studies. They could be said to be about the obesity paradox, healthy lifestyle paradox and figure flaw-paradox…

Anymore, epidemiology has become a vehicle to find associations between every aspect of our everyday lives or our physical features and risks for some feared disease. And it’s being misused to convince us that our diets and lifestyles or appearances are the cause of ill-health. Blame, guilt and fear are the bread and butter of health marketing. That’s why carefully controlled epidemiological studies that find no link — those null studies that rarely get reported — are especially valuable. If there’s not even a strong link between two variables, then a variable can’t possibly have a causal role. Null studies tell credible scientists, and should tell us, to move on and stop worrying about that.

It can often be difficult for the public to understand what makes some epidemiological studies stronger than others — such as dredging through data compiled from self-reported questionnaires versus actual measurements from medical exams. Epidemiological studies have reported contradictory correlations between fatness and mortality risk among mature adults and it’s often suggested that it’s because cardiovascular fitness hadn’t been considered and could be an independent confounding factor.

Fat and fitness

Researchers, led by Dr. Paul McAuley with the Department of Human Performance and Sport Sciences at Winston-Salem State University in North Carolina, set to test the hypothesis that high cardiovascular fitness and high BMI were associated with a lower risk for death among healthy older men. As they noted, most studies, and the strongest ones, point to an inverse relationship between BMI among mature adults and mortality, with obesity having a protective role. Obesity’s survival advantage among patients with a wide range of diseases and health problems has also been especially well documented in the medical literature. Could being fat be associated with lower risk for premature death among healthy adults, and is fitness an independent risk factor?

Method. The researchers examined the data of 2,469 men consecutively enrolled in the Veterans Exercise Testing Study who had completed a full physical medical exam and maximal exercise testing** at one of two university-affiliated Veterans Affairs medical centers during 1987-2004. The men were age 65 years and older. Mortality data was gathered from the Social Security Death Index and the California Death Registry. They restricted their study to healthy men to rule-out those who might be underweight or physically inactive because of health problems. Their results were published in the Journal of Gerontology A Biological Sciences and Medical Sciences.

Findings. Among 981 healthy older men, 208 died during 6.9 years of follow-up. Compared to the reference ideal of a “healthy” BMI (20-24.9), men who were overweight were associated with a 34% lower risk for all-cause mortality, while the obese men (regardless of the degree of obesity) were associated with a 44% lower risk. In contrast, men with BMIs under 20 had more than a two-fold higher risk for premature death. When cardiovascular fitness was controlled for (as measured by MET = 3.5 mL/kg/min oxygen uptake on exercise tests), the slim men with BMIs below 20 were associated with an even higher 2.5 fold higher risk for premature death. Meanwhile, the most obese men had the lowest risk for all-cause mortality of all, at less than half (HR= 0.44) the “normal” weight men. As the authors noted, none of these correlations were significant. However, they do help to dispell popular beliefs about the deadliness of being fat as we age.

The researchers attempted to parse out these relationships by looking at obesity and physical fitness as they relate to risks for all-cause mortality. They eliminated all of the underweight men with BMIs below 20. Still, the overweight men had a lower risk for death than the “normal” weight men, and the obese men had the lowest risks of all (about half that of “normal” weight men), at every level of fitness.

In fact, the men who were the most obese and sedentary had a similar risk for all-cause mortality (HR=0.56) as the “normal” weight men who were the most physically fit (HR=0.49). This finding certainly didn’t make the headlines. Beliefs among the general public about both the benefits of exercise and the dangers of obesity as people age appear beyond what the evidence supports.

These results are consistent with the largest Aerobic Center Longitudinal Study (ACLS) at the Cooper Clinic in Dallas, Texas, on younger adults which had focused on fitness and reported it attenuates the risks associated with obesity. The ACLS had clinically followed more than 25,000 civilian men for over ten years and the data actually found a small, consistent survival advantage the heavier the men were. The Cooper Institute of Aerobics Research has performed similar studies on more than 113,000 women.

Lessons lost

Not surprisingly, the media largely ignored this latest study. While it’s an epidemiological study and not evidence of causation, its value as a null study was lost. The public also didn’t hear another point the authors made: that cardiovascular fitness is influenced by many factors, which includes age and heredity.

Yet the popular condemnation of people without high fitness levels is rarely recognized as a form of discrimination. Fitness and lifestyle preventive medicine have become such big business, and bigger politics, many people have come to believe that everyone must engage in similar types and intensities of activity (i.e. exercise) to live longer and be healthy. Those who don’t follow leisure-time exercise regimens are labeled as having sedentary lifestyles and blamed for putting themselves at risk for premature death, even when they're active all day in their work.

Besides wordsmith plays on definitions, correlations between exercise and lifespan can mislead us when we fail to remember that leisure-time exercise and sports activities are largely markers for youth and socioeconomic status — yet older age, and lower class and poverty, are two of the biggest risk factors for chronic diseases of aging and death. Fitness, body type, physical abilities and strength also have strong hereditary components. Yet a correlation between people who don’t have athletic physiques and their lower participation in sports activities is often mistaken for reverse causation.

Today’s beliefs in exercise can also mean we fail to explore other potential links that are equally, if not more, important to people’s overall health and well being. The most careful exercise intervention studies show that inappropriate conclusions about causes and effects have overlooked more significant social and productive activities.

Beliefs can also mean we fail to weigh the risks for harm of imposing our beliefs that everyone needs to have the same lifestyles and follow one-size-fits-all exercise prescriptions, in order to be healthy. What may be healthful for some 20-year olds, for example, may not be for a growing child or older adult or senior.

Babyboomers, the first generation to grow up exercising, have led to what’s known among medical professionals as boomeritis. Sports and exercise injuries have become the number two reason for doctor’s visits, behind the common cold, according to the CDC’s National Ambulatory Medical Care Surveys. Athletic activities among middle-aged adults were the source of 488 million work day restrictions in 2002, according to the Bureau of Labor Statistics, while the Consumer Product Safety Commission documented that by 1998, sports-related injuries among boomers were responsible for $18.7 Billion in medical costs. The AHRQ's Medical Expenditure Panel Survey (MEPS) found that injury-related medical care accounted for about 57 percent of all payments made by Worker's Compensation programs in 2002. The medical literature continues to bring reports of similar risks for injuries among children.

Scientists understand the importance of testing hypotheses about causes and effects — and balancing overall benefits over risks — using carefully designed randomized, controlled clinical trials and measuring hard clinical outcomes. Yet, every randomized, controlled clinical trial of “healthy lifestyles,” as popularly defined, has failed to significantly reduce premature deaths from all causes or to prevent chronic diseases of old age.

As the recent review in the Journal of the American Medical Association pointed out, this is what separates science from ideology.

© 2009 Sandy Szwarc. All rights reserved.

* Social media marketing is sadly helping to train us not to think. It’s more comfortable to see what everyone else says and what’s popular, such as on online forums, before deciding what we will believe.

** Clinical Evaluation and Exercise Testing

All participants completed a symptom-limited maximal exercise test using an individualized ramp treadmill protocol… Immediately prior to the exercise test, height and weight were measured using standard procedures, and BMI was calculated as weight in kilograms divided by the square of height in meters. A microcomputer automatically increased workload after an individualized walking speed was established and predicted values for maximal exercise capacity were entered. A 12-lead electrocardiogram was recorded each minute, and blood pressure was recorded on alternate minutes throughout the test. Standard clinical criteria for terminating the tests (e.g., fall in systolic blood pressure, STsegment depression >2.0 mm, dangerous arrhythmias) were followed, but no heart rate or time limit was imposed, and a maximal effort was encouraged. Standardized equations were used to determine the calculated peak METs on the basis of treadmill speed and grade . Exercise capacity was expressed as the maximal MET value attained during the exercise test.

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

Single payer visions

We’re beginning to learn what Senator Edward Kennedy’s secret meetings with key health insurance industry stakeholders have been creating in their vision for universal health coverage.

If you want to keep your health care separate from your job, you will no longer have that choice, according to reports of the plan’s 170-page draft. Employers would be required to provide health care to employees or be penalized. Step #1 to a single-payer government managed national health plan.

If you want to self-insure or receive care from independently-practicing doctors, you will no longer have that choice. Every American would be forced to buy health insurance or be penalized through their income taxes and the penalties would be collected by the Internal Revenue Service. As the Washington Post reports, this mandate provision will guarantee 20 million more customers for the insurance industry.

If you want to spend your money on a traditional type of insurance plan that insures against major medical expenses or that offers specific coverage you feel is best for you, you will no longer have that choice, according to reports of the plan. You would have to buy a plan that complies with the stipulations determined by a new government “Medical Advisory Council” under the auspices of the Health and Human Services Department. Plans would be required to cover certain preventive services. It is not health insurance, but managed care with compulsory preventive interventions.

In true doublespeak, the plan is called the American Health Choices Act.

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Step and repeat: the fast and easy way to use our noggins on flu fears

Sadly, judging by the news and internet buzz, a lot of innocent people are frightened all over again each and every time the same scare makes the news. But the lessons learned the first time you hear a scare can be applied the next time you hear it. Let’s look at three helpful adages:

1. Diagnosis ≠ incidence
More people diagnosed with a disease does not equal more cases of a disease. The corollary to this is more people seeking to be examined or tested for a disease does not equal more cases of a disease. This is sometimes referred to as the “seek and ye shall find” fallacy.

2. Bigger numbers ≠ better evidence
If claims of ten cases of some new disease are based on flawed science, the science doesn’t become more credible by claiming 100-fold more people are diseased. This is also sometimes referred to as “bigger numbers = bigger lies.” Don’t be scared by numbers.

3. “What-if” speculations ≠ science
Speculative scenarios and predictions with no credible evidence to back them up, or even their plausibility, are nothing more than scare marketing (aka scare mongering). Credible scientists and medical professionals don’t use scares to sell you on something, they objectively report the sound facts and body of evidence, along with risks and benefits, so that people and patients can make informed decisions for themselves. Try hard to look for the facts, then check them, and distinguish them from the “what-ifs.”

Let’s take a critical look at some of the latest scary news and myths about swine flu that give us an opportunity to apply these adages.

Media releases and news reports don’t always — okay, almost never — give us the complete story or leave us with accurate impressions. The subjectivity and play on our emotions, however, isn’t always apparent. A Reuters article titled “US Health officials troubled by a new flu pattern,” on May 18^th was typical of those we’ve been reading.

Reuters reported that, according to health officials, the new influenza strain spreading across the country is “putting a worrying number of young adults and children into the hospital and hitting more schools than usual.” The story went on to report that the virus had killed a school principal. Dr. Anne Schuchat of the U.S. Centers for Disease Control and Prevention [Interim Deputy Director for the Science and Public Health Program] was quoted saying that it’s “very unusual to have so many people under 20 to require hospitalization and some of them in (intensive care units).”

According to the news article, there’s more influenza this year overall. “We are seeing more reports of influenza-like illness from outpatient visits that we monitor than is typical for this time of year,” Dr. Schuchat said. Dr. Thomas Frieden, identified as the New York City Health Commissioner,* agreed, saying: “We’re seeing increasing numbers of people going to emergency departments saying they have fever and flu, particularly young people.”

● Gulp. Did the words “troubled,” “worrying” and “killed” leave you feeling anxious? As we know, any time health reporting leaves us feeling worried or anxious, that’s our baloney alert that our emotions are being played and what we’re hearing is more marketing rather than an objective presentation of the medical research and scientific evidence.

● Did you catch the most glaring fallacies in the claims? After incessant media hype about an impending swine flu pandemic, consumers have been scared and are running to the doctor for every sniffle and cold symptom, fearing they’re going to die of swine flu unless they seek immediate treatment. Reports of more flu-like symptoms being seen at clinics and emergency rooms is an indication of swine flu panic, not actual disease.

In fact, the problem of people flooding emergency rooms, fearing they are infected, became so extreme that on April 30^th, the nation’s two largest organizations of emergency medical professionals — the American College of Emergency Physicians and the Emergency Nurses Association — issued a joint statement urging consumers to apply the “prudent layperson standard” when considering going to the emergency room: “If the average prudent person would think you have the symptoms of a medical emergency, then you need to seek emergency care,” they said. If you don’t have emergent symptoms, don’t go to the ER.

Emergency medical professionals across the country have been inundated by people “seeking reassurance that they are not ill,” which both organizations said was “understandable, given the widespread news coverage.” They reminded the public, however, that while news reports about the swine flu may have raised alarm, the actual number of cases are very small. Their joint statement emphasized:

“If you have symptoms that would not ordinarily take you to the emergency department but are considering going because you are afraid you have swine flu, you probably do not need to go,” said Bill Briggs, RN, president of ENA.

Plenty of healthcare professionals probably wished they could just get away with this other approach in providing the answer to people wondering if they have the swine flu.

● Did anyone read the transcripts of the CDC’s briefing or look at the CDC flu reports to fact check? None of those scare words were used in the briefing. Reporters could easily have checked the facts, but almost no one did. [Click on any graphic to view enlarged.]

According to the CDC surveillance data, the numbers of children being hospitalized this 2008-9 influenza season [the dotted red line] are not greater than in other recent flu seasons:

Nor are the number of pediatric deaths associated with influenza this season any higher than recent years. In fact, they’re significantly lower. For example, there were 78 pediatric deaths associated with influenza in 2006-7, 88 deaths in 2007-8, and by May 30^th this season’s total number of pediatric deaths was 67.

There are also not inordinately more cases of influenza overall this season, even including this novel strain. With the heightened testing, more cases being identified of all influenzas would not have been unexpected. Yet, seasonal flu cases have not even been near epidemic thresholds. In fact, CDC surveillance data reveals that this year’s total influenza cases [the last red bump on the right] have generally been below seasonal baseline. In contrast to all of the flu panic, this year has been a mild year for influenzas of all types:

The CDC surveillance data also shows that, in contrast to this year, most years over the past decade have exceeded “epidemic thresholds,” especially years where H3N2 type A influenza is the predominant strain.

Testing. If you’re confused by these facts that conflict with what you’ve come to believe about an impending flu pandemic, you may have missed the earlier coverage, where we learned that the CDC had cautioned that this strain of swine flu (H1N1) could not credibly be said to be new. The reason is because they had never tested for it before and between the new test, along with the new mandatory reporting and increased testing, they could be identifying a strain of H1N1 that has always been part of regular seasonal influenza. More cases identified by a new test and increased surveillance does not necessarily mean there actually are more cases.

As Dr. Schuchat explained to the media on May 18^th:

Our CDC efforts [to test for this strain] continue fairly aggressively. We still have more than 80 people deployed in the field, and we have continued to support the laboratories and states here in the U.S., as well as in countries shipping our diagnostic kits to 95 labs in 50 states, and to 237 labs in 107 countries. At this point, 40 of the states here in the U.S. have got validated testing going on.

Prudence is also warranted when interpreting results of a new lab test. There are reports of contradictory results, depending on the lab and the test, and a lot of people heard they could have swine flu based on rapid tests which later proved to have been negative. The CDC’s recommended test for this novel H1N1 strain is the real-time reverse-transcription polymerase chain reaction (RT-PCR) test, or a viral culture. “Currently, novel influenza A (H1N1) virus will test positive for influenza A and negative for H1 and H3 by real-time RT-PCR, their guidance states. “If reactivity of real-time RT-PCR for influenza A is strong (e.g. Ct <30) it is more suggestive of a novel influenza A (H1N1) virus.”

The CDC also cautioned medical professionals that the sensitivity and specificity of various rapid tests is not known and that it has received reports of false positives and false negatives. The reliability of the new rapid tests of this strain of swine flu, the CDC said, “depends largely on the conditions under which they are used and are entirely based on the experience with seasonal influenza”:

For detection of seasonal influenza virus infection, sensitivities of rapid diagnostic tests are approximately 50-70% when compared with viral culture or RT-PCR, and specificities of rapid diagnostic tests for influenza are approximately 90-95%. Sensitivity and specificity of these tests for detection of the novel H1N1 flu virus are unknown. False-positive (and true-negative) results are more likely to occur when influenza is uncommon in the community…

Mutant virus.During the May 18^th CDC media briefing, Dr. Schuchat also said that “from the stains we’re testing there is no evidence right now of any mutation toward a more virulent strain.” We learned that genotyping of the virus by scientists showed that it never was a new mutant swine virus with unique dangers compared to ordinary seasonal flu and that there’s no evidence that it’s more likely to become deadly than any other swine flu virus has ever been.

Seasonal flu and H1N1. Let’s read the transcripts of a later CDC media briefing on May 28^th and look at a few supported facts that we haven’t been hearing, and try to keep them separate from the speculations and claims. Dr. Schuchat said they’re not seeing dramatic large increases in H1N1 cases. In fact, beginning next week, she said, the CDC is going to be issuing updates less frequently.

She went on to explain that H1N1 strains have always been part of seasonal flu and that this newly identified strain is behaving much like typical seasonal H1N1 influenza strains, and that seeing the virus in younger people is common for H1N1 strains (nothing ominous about this season's H1N1):

Next I want to talk a little about what we've learned about the virus so far. There are some respects in which this virus is behaving like the seasonal H1N1 influenza viruses. Remember that for seasonal influenza, we usually see H1N1, H3N2 and B strains of influenza. And when we look at this novel H1N1, there's some similarities between this and the seasonal H1N1. Seasonal H1N1 often causes more disease in younger people compared with the other strains that can be more common in older people. The seasonal H1N1 typically doesn't cause as many deaths as the H3N2 seasonal viruses do. In years when H3N2 predominates, we have a higher death toll than in years when the H1N1 predominates. So during the annual flu seasons, we've often found that H3N2 influenza viruses are most strongly associated with severe illness and more deaths. Back to the novel H1N1 virus, currently the attack rates that we're seeing, that's the percentage of contacts of an infected person who becomes ill, are fairly consistent with what we see with seasonal flu. In a typical influenza season, about 7% to 10% of the people in a community may become infected with an influenza virus.

Virulence. She also reported that they have information on 11 of the 12 deaths reported as being associated with the virus. Ten of those deaths, she said, occurred in people with serious underlying health conditions that put them at risk for severe complications — in other words, opportunistic infections such as the flu.

But this virus hasn’t proven to be anywhere near as virulent as the 1918 pandemic, she said, which had a mortality rate in the 2 percent range. Deaths from this strain of H1N1 are so low, she said, “it’s hard to be very precise in these ranges that we’re seeing right now of 0.15% or 0.2% of all cases resulting in death.”

As of Friday, WHO reports that the total number of deaths worldwide that have been linked to swine flu (H1N1) this year are 125. According to the CDC, between 250,000 and 500,000 people die worldwide each year from the seasonal flu. In comparison, about 1.2 million people die from walking, cycling or riding on roadways, the highest deaths are among children walking along a road.

As Dr. Peter Collignon, a microbiologist with Australian National University, said, “the virus is no worse than annual influenza strains.” “I don’t actually think this particular strain appears from the data... to be worse than what we do predictably see every year,” he said. “My major concern about what’s happening is the fear is out of proportion to what the data shows.”

The "fear factor" within the community, he said, needs to change. Yes, you can let yourself be scared senseless about all sorts of “what-ifs” but why would you want to?

Should swine flu be declared a pandemic?

How many times have we heard that when or if the World Health Organization calls swine flu a pandemic, then it’s time to feel really scared because that means a deadly virus is spreading around the world? Before we run for the hills or invest in a biohazard suit, we know that the very first question we should ask ourselves about any health statistic is the definition. The WHO definition of pandemic is based on “how widespread a disease has become, without regard to its severity.”

“People don't understand what 4, 5 or 6 means,” said Jose Angel Cordova, Mexico’s Health Minister. “They think that when you go to a higher level [of alert] things are worse.”

Much of the recent fears are based on beliefs that a new flu strain means we’re doomed to die because we have no immunities to it. But, as we’ve seen for nearly a century with every outbreak of influenza, just because we haven’t developed resistance to specific strains doesn’t make them any more deadly. While the word “pandemic” sounds scary to laypeople, every influenza pandemic we’ve had since 1918 has been no more deadly than a typical flu season.

How many times have we heard the dire warning that it’s only a matter of time before the next influenza pandemic strikes? “But the truth is that the threat is being hyped,” explained Philip Alcabes, Ph.D., MPH, professor of urban public health at Hunter College of the City University of New York. It’s a myth that we need to brace ourselves for another pandemic like the Spanish flu, he wrote in the Washington Post.

“Fortunately, we’ll never see another flu outbreak of that sort,” he said. The Spanish flu hit at a time when the population’s immune systems were severely weakened by widespread food shortages, displaced refugees and health consequences of World War I. Most flu deaths also weren’t from the flu itself, but from the bacterial infections that attacked weakened respiratory systems. People in developed countries are not only healthier today, antibiotics and modern medical care mean a repeat of a pandemic of that magnitude is simply improbable.

As we’ve seen with other purported epidemics (obesity, diabetes, metabolic syndrome, autism or toe fungus), even calling something an epidemic or pandemic brings vast financial, political and ideological interests — on even how we should eat and live — to bear. The same is true with influenza.

● For example, warnings of a global pandemic of bird flu several years ago — which the soundest scientific and medical evidence indicated were similarly improbable, and with equally implausible predictions of deaths — were used to put Homeland Security in charge of a national pandemic response plan, increase federal funding for this new agency, buy 2.7 million doses of vaccines and antivirals, and introduce a massive data collection and public health reporting system. Those opposed to commercial food production, meat consumption and globalization used it to heighten scares and denigrate the poultry industry and imports from China.

● This April, the Administration was already calling for $1.5 billion more in funds to address swine flu which, according to Congress Daily, was on top of $1.4 million additional spending for pandemic flu over last year and $6.1 billion for pandemic preparedness the HHS had been given in other spending bills. Three pharmaceutical giants Sanofi-Aventis, GlaxoSmithKline and Novartis were given $191 million, $181 million and $289 million, respectively, to rush a vaccine into development.

● This week, the White House asked for an additional $2 billion to prepare for a swine flu pandemic and the power to use another $3 billion from the discretionary stimulus funds.

● The same groups opposed to commercial food production, meat consumption and globalization have been directing scares to pigs and commercial pig farmers. That’s probably why we aren’t likely to see an epidemic declared, linking impending doom to cute little bunnies. Not many people eat bunnies and there’s not much of a movement against factory bunny farms. :)

But don’t blame the pig, said virus expert Dr. Robert Webster of St. Jude Children’s Research Hospital in Memphis, Tennessee. “It’s a human virus.” Those pointing the blame for creating new viruses at modern pig farming, with claims of crowded unnatural environments, can cite no science to support the claims, the Los Angeles Times reported. As it explained:

Animal scientists say that [the factory farming connection] is not so. The biologically secure facilities, they say, protect pigs from germs like flu. The air is filtered, and bacteria-rich animal waste is kept out of pens. There is virtually no exposure to wild birds or other animals.

The number of humans who come into contact with the animals is far lower than on traditional farms, reducing risk of infection either way. People entering the facilities must shower and change into special clothes. “You don't even wear your own underwear in these facilities,” said Dr. Liz Wagstrom, a veterinarian and officer of the National Pork Board…

Animal breeder Ronald Bates of Michigan State University said that should be a warning: "If you have flu-like symptoms, don't go near pigs."

When so many interests stand to gain from creating panic over epidemics and pandemics, it means we have to be especially diligent to look for factual information in order to not let ourselves get caught up in the fear marketing. Sadly, when fears get the better of people, they can even be led to welcome the label of an epidemic or pandemic to validate that their fears are real, even when they’re not.

But what does WHO raising the level of alert from 5 to 6 and declaring a pandemic really get you?

Declaring a pandemic has more to do with politics than with medicine or helping you to stay safer. In fact, responses to fears about a pandemic are far more frightening and dangerous than the flu itself.

The belief that “we can’t be too prepared” isn’t true. “Actually, we run the risk of doing more harm than good by overreacting to the threat of a pandemic,” said professor Alcabes. Remember the 1976 swine flu outbreak at Fort Dix, New Jersey? It also resulted in medical experts warning of a pandemic and led the president to call for a mass inoculation program of the population with a new swine flu vaccine that contributed to about 500 cases of Guillain-Barré syndrome and 32 deaths before it was shut down. “But there was no swine flu epidemic, just a handful of cases,” professor Alcabes reminded us.

A pandemic announcement itself comes with considerable risks to people’s lives, health and safety, while offering little benefit. As was reported from WHO’s annual meeting last month, declaring a pandemic has severe economic consequences for nations, triggering expensive trade and travel restrictions such as border closures, airport screenings and quarantines. Mexico is still reeling from the economic hit it took when it literally shut down its economy for nearly two weeks trying to protect others from the spread of the infection because of fears of a pandemic. Its tourism and restaurant businesses were hit especially hard, with about 25,000 workers losing their jobs in Mexico City alone after more than 2,500 restaurants closed.

In declaring a pandemic, “governments may also fear outbreaks of mass panic, social disruption and increased pressures on their health systems,” WHO reported. “Under public pressure, extraordinary measures such as large-scale pig slaughters like the recent one in Egypt could be taken, whether or not they are scientifically justified.”

Fear and a sense of crisis causes extraordinary levels of stress and anxiety among people that can linger long after the crisis is over. In Japan, school children who’d come down with the flu have suffered an onslaught of hostility, threats and discrimination from frightened members of the community, blaming them for the spread of the infection.

People who are worried and anxious also seek more medical care. Needless scares have very real consequences by putting more strain on overworked doctors, on limited healthcare resources, and on cash-strapped consumers, themselves.

“Today, about 85 percent of the burden of chronic diseases is concentrated in low and middle income countries,” said Margaret Chan, Director-General of WHO. “The implications are obvious,” she said. “The developing world has, by far, the largest pool of people at risk for severe and fatal H1N1 infections.” A pandemic declaration will most harm underdeveloped countries whose health systems are already unable to take care of the deadliest health problems, such as diarrheal diseases that kill about 600,000 children under five every year in India or malaria that kills more than 3,000 children a day in Africa. Countries should not let fears over a possible flu pandemic overshadow or interrupt other vital health programs, she cautioned.

The bottom line, the term “pandemic” can itself be deadly. Fear can lead people to respond emotionally and in ways that aren’t very sound or based on reasoned evaluations of the benefits and risks. For every country and every person of the world, diverting precious healthcare resources away from caring for actual deadly diseases to put towards poorly thought out public health measures, means more people will die.

© 2009 Sandy Szwarc

* Dr. Frieden had actually resigned the prior week when President Obama appointed him the new Director of the CDC.

Readers may recall Dr. Frieden when he lead the recent initiative to put the entire population on a low salt diet. Many of the other accomplishments Dr. Frieden cited in his media release about his resignation may also be familiar:

New York City now has the nation's largest community-based electronic health record project — one designed specifically to make prevention central to health care. More than 1,200 local health care providers — many of them practicing in the city's poorest and sickest neighborhoods — have joined the city's Primary Care Information Project.

New York City led the nation in eliminating artificial trans fat, a known cause of heart disease, from restaurant foods. [Dr. Friedman had equated the invisible dangers of trans fats to lead paint.]

By mandating the posting of calorie information in chain restaurants, the city's Board of Health empowered consumers to make healthier food choices at the point of purchase and encouraged restaurants to offer healthier options.

New York City created the country's first A1C registry to monitor blood sugar levels among people with diabetes. [Reviewed here and here.]

He also noted: “Since 2004, the Health Department has spearheaded Take Care New York, the City’s first comprehensive health policy, targeting ten leading causes of preventable illness and death for coordinated public and individual action.” We may all soon be familiar with this program. The Keep Your Heart Healthy: Take Care New York, says that being overweight or obese causes a wide range of health problems and that you can cut risk by just losing a few pounds, eating right and exercising, including cut your risk of diabetes in half; it tells everyone they must “know your numbers” to prevent disease; eat at least five servings of produce every day, eliminate any sugary sodas, and it offers a variety of tips for sustained weight loss.

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

Beware the false RCT

When we hear about a study from a randomized, controlled clinical trial, it’s easy to give the findings more importance than we would correlations derived from an observational study. But a study from a randomized controlled clinical trials isn’t always about a randomized controlled clinical trial. Increasingly, it’s an epidemiological study in disguise.

Even medical professionals get taken by this growing technique. It’s most common when secondary studies use the database from participants in a randomized controlled trial to look for correlations — not to scientifically test a hypothesis, let alone one the original trial had been designed to fairly test. Carefully controlled clinical trials are concerned with causes and effective treatments. In contrast, multivariate analyses of large databases, with their statistical manipulations and regression computer modeling, are statistics. Statistics is about correlations. It’s not biological research.

When we fail to look closely at a study’s methodology, it can be easy to miss when a randomized controlled trial has morphed into an observational study. This was seen last week when authors of a meta-analysis on tight blood sugar control for type 2 diabetics wrote in The Lancet:

More recently, extension of the initial randomised groups in the UKPDS study has shown a reduction in myocardial infarction and all-cause mortality with both metformin and sulphonylurea-insulin regimens.

By calling it an “extension” of a randomized intervention trial, did you think that this secondary study was a randomized clinical trial? As we examined, the original UK Prospective Diabetes Study (UKPDS) was designed to see if improving blood sugar control can help prevent the complications of type 2 diabetes. It had begun in 1977 and was completed in 1994 and the primary results published in 1998. The UKPDS found that the intensive medical management did not reduce any adverse clinical endpoint or all-cause mortality, and was possibly associated with higher risks for some patients.

The study cited by The Lancet authors as being an extension of the original trial and used to reverse the study’s original null findings to now suggest that the interventions were effective, was published last fall in the New England Journal of Medicine.*

Briefly, of the original 4,209 newly-diagnosed type 2 diabetics who had been randomized in the UKPDS trial, the authors used data compiled from questionnaires received on 1,525 of the participants, six and ten years after the trial had been completed when no further clinical follow-up was done. Information was also obtained from the Office of National Statistics. The authors noted that during the decade since the trial was completed, no efforts had been made to maintain the interventions the participants had received during the UKPDS trial. They then performed statistical modeling to calculate serial hazard ratios associated with seven outcomes, according to the intervention categories the participants had been assigned to during the original trial.

Did you catch when it stopped being a randomized controlled clinical trial?

When the original study ended.

It was nothing more than an observational study looking for correlations. Just because the questionnaires came from some people who once participated in a clinical trial doesn’t change that. The controlled interventions ended a long time ago.

If a dentist you hadn’t seen in ages attributed the beautiful smile you have today to a cleaning he once gave you fifteen years ago, would you find the evidence compelling? Or, would you think it might have more to do with the multiple dental procedures, sealants, teeth whitening and fluoride treatments you’d had since then?

If a randomized, double-blind, placebo-controlled clinical trial was completed 15 years ago, and you sent the participants a questionnaire today asking them about their health, would you find the correlations compelling evidence that the clinical trial intervention was the cause for their health status? Or, would you think the correlations might have more to do with countless other medical interventions, life situations and life-changing events, and doctors they’d seen in the interim?

Would you want the FDA to approve a drug based on questionnaires returned from only one-third (36%) of study participants, or would you want them to know what happened to the other two-thirds? Worse, would you want the randomized clinical trial evidence ignored and treatment guidelines based on this evidence — guidelines that become the performance measures (P4P) your doctor must follow to be paid and that you must follow to retain health insurance coverage?

By mistaking this observational study for a randomized, controlled clinical trial, peer reviewers may have not looked as closely to see its numerous weaknesses (“biases”) that made it fail as a fair test of anything. For example, the participants were not representative of the original cohort of type 2 diabetics (those who turned in the questionnaires were two years older and included significantly more minorities), no information about the diabetics’ treatment for the past decade was known or considered, and their computer modeling didn’t control for even the most significant factors in mortality, such as social-economic status. Even then, the results wouldn’t be considered tenable.

This is an example of why it’s important to understand that all studies are not created equal. Studies that are not designed to be fair tests of an intervention can lead to conclusions about treatment effects that are systematically different from the truth. The importance of sound science and randomized clinical trials properly designed to be fair tests of an intervention, with the findings objectively interpreted, really does matter.

But it may be up to you to know the difference.

© 2009 Sandy Szwarc

* The study’s published disclosure statements:

Dr. Holman reports receiving grant support from Asahi Kasei Pharma, Bayer Healthcare, Bayer Schering Pharma, Bristol-Myers Squibb, GlaxoSmithKline, Merck, Merck Serono, Novartis, Novo Nordisk, Pfizer, and Sanofi-Aventis, consulting fees from Amylin, Eli Lilly, GlaxoSmithKline, Merck, and Novartis, and lecture fees from Astella, Bayer, GlaxoSmithKline, King Pharmaceuticals, Eli Lilly, Merck, Merck Serono, Novo Nordisk, Takeda, and Sanofi-Aventis, and owning shares in Glyme Valley Technology, Glyox, and Oxtech;

Dr. Paul, receiving consulting fees from Amylin;

Dr. Bethel, receiving grant support from Novartis and Sanofi-Aventis and lecture fees from Merck and Sanofi-Aventis;

Dr. Matthews, receiving lecture and advisory fees from Novo Nordisk, GlaxoSmithKline, Servier, Merck, Novartis, Novo Nordisk, Eli Lilly, Takeda, and Roche and owning shares in OSI Pharmaceuticals and Particle Therapeutics; and

Dr. Neil, receiving consulting fees from Merck, Pfizer, Schering- Plough, and Solvay Healthcare. The Oxford Centre for Diabetes, Endocrinology and Metabolism (OCDEM) has a Partnership for the Foundation of OCDEM, with Novo Nordisk, Takeda and Servier. No other potential conflict of interest relevant to this article was reported.

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

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

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

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

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

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?

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

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

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

Science says isn’t always what science found

We haven’t covered a bird cage news story in awhile, so let’s test our critical reading skills with one that’s been in the news. It’s reported that researchers have found that women who take probiotics during pregnancy can ward off postpartum obesity. What tipped you off that this news story was worthy of lining your bird cage with the newspaper it was printed on?

More than 246,000 news stories about probiotics during pregnancy for reducing fat already appear on Google. The claim made its way around the world in nanoseconds and is well on its way to becoming a truism.

The headlines have become increasingly sensational this past week — reporting that probiotics “may help ward off” postpartum obesity, to probiotics “can” reduce obesity, to probiotics do “cut belly fat” and even telling the public that probiotics “could spell end to need for obesity treatment!”

Every news report, however, has presented the same version the story — the one that appeared in the press release. When we see countless news stories at the same time all giving the same version of a study, it’s a dead give-away that some marketing department issued a press release. Releasing research directly to the media is not how credible science is reported. Press releases rarely present research objectively and fully. They typically not only fail to reveal a study’s limitations, they also exaggerate the significance of the findings, explained Drs. Steven Woloshin, M.D. and Lisa Schwart, M.D.. Science by press release isn’t science at all, it’s marketing.

No reporter read the research to report the findings first-hand. Not a single medical professional read the research to peer-review its methodology and provide critical analysis of its findings to offer balance to the news accounts. Why? There was no newly published study on probiotics and postpartum obesity to examine. The research in the news was from an abstract (T1:RS1.3) released in a 15-minute oral presentation at a conference, the European Congress on Obesity in Amsterdam. In other words, the news was anecdote squared: we’re hearing what a reporter says a researcher said her research found. As we know, abstracts presented at scientific meetings often generate lots of media coverage but are typically so flawed that they rarely get published in peer-reviewed publications — that’s the case with at least six out of ten clinical trials, according to Kay Dickersin, Director of the Center for Clinical Trials at Johns Hopkins University.

According to the press release, the study was presented by Kirsi Laitinen, a nutritionist and senior lecturer at the University of Turku in Finland. In the study described, 256 women were randomly divided into three groups during their first trimester of pregnancy. Two groups were given special dietary counseling for “healthy weight gain and optimal fetal development” along with special foods with “healthy” fatty acids and added fiber; half of those women were given a special probiotic supplement (Lactobacillus rhamnosus and Bifidobacterium lactis) to take during their pregnancy and during postpartum while breastfeeding; the other women on the diet were given a placebo. A third group ate their normal diet and received only a placebo. The women were weighed and measured at the start of the study and again during their third trimester; and at 1, 6 and 12 months postpartum. One year after childbirth, the women who had been taking the probiotic supplement “had the lowest levels of central obesity as well as the lowest body fat percentage,” said Laitinen.

Their study, she said, was “the first to demonstrate the impact of probiotics-supplemented dietary counselling [sic] on adiposity.” This, however, contradicted her closing remarks: “There is growing evidence that this approach might open a new angle on the fight against obesity, either through prevention or treatment.”

The press release suggested that probiotic supplements could play a role in a range of diseases. The only limitations noted about this study was that it failed to control for the mother’s pre-pregnancy weight or determine if the probiotic supplements had any effect on the health outcomes of the mothers or babies. These limitations had far greater significance than was realized by most reporters, most of whom failed to even mention them. Did you catch the significance? Laitinen reported that the women taking probiotics were less fat than the other groups one year after delivery — but it turns out that these women were less fat to begin with! (And there was no difference between the groups in the changes in their weights during pregnancy or after delivery.)

Filling in the blanks

This study was conducted by researchers at the University of Turku Functional Foods Forum. Their research is in nutrigenomics [reviewed here and here] and probiotic supplements. As Seppo Salminen, head of the University’s Functional Foods Forum, explained last year at the Universität Bodenkultur in Vienna, Austria, they are working on probiotics for preventing or reversing allergies and eczema in infants and children, autism, respiratory infections and obesity; plus for detoxification, binding “toxins,” genomics, and to enhance longevity and slow the rate of aging and age-related diseases.

Laitinen and Seppo, along with study co-author Erika Isolauri, are the inventors of an international patent (application date 4.7.08) of probiotic supplements for women during pregnancy for preventing diabetes, for glucose normalization, for improving insulin sensitivity and reducing the risk of metabolic syndrome. Any pill that the public believes will do all that is sure to fly off the shelves.

In the patent documents, filed in 2007, the authors supported their patent application based on the findings of their NAMI-tutkimusohjelma study, “Effects of Maternal Nutrition During Pregnancy and Breast Feeding on the Risk of Allergic Disease in Child.” This study of probiotic supplements during pregnancy for treating and preventing allergic inflammation and atopic diseases — as registered at Clinicaltrials.gov NCT00167700 — was due to be completed on an estimated 600 women in September 2010.

The findings on only 256 pregnant women were reported in their patent application, and the following year were published in the November 2008 issue of the British Journal of Nutrition. No explanation was given for what happened to the rest of the planned study participants. Starting out, the study data showed that the women in the probiotic group weighed about 13.4 pounds less at the start of the study than the diet/placebo group, but there was no statistical difference in the amount of weight the women in the different groups gained during pregnancy or in their weight at one-year postpartum, or in changes in their BMIs. The diet and probiotics had no effect on the birthweights of their babies. Nor was there any difference among the women in how long they breastfed. As the authors reported:

There was no distinction between the groups in terms of pregnancy weight gain, baseline adjusted weights during pregnancy or postpartum BMI. The mean duration of exclusive breast-feeding and thus the duration of probiotics/placebo intervention did not differ amongst the study groups.

Concerning high blood sugars during pregnancy (a marker of gestational diabetes), the risk in the probiotic group was “not statistically significant” and the “relative risk was not significantly lowered as seen on glucose challenge tests given to 45% of the women during their pregnancy. Similarly, “mean glycated haemoglobin A1C were comparable amongst the study groups at the third trimester of pregnancy and 12 months postpartum.”

By all objective measures, this was a null study and probiotics had no effect on pregnancy weight gain, postpartum weight loss, infant weight or the women’s blood sugars.

Once again, we’re reminded that studies’ conclusions don’t always reflect their actual findings. The patent authors concluded: “This study provides the first evidence of an active dialogue between the host and the gut microbiota in glucose metabolism… Probiotics appeared to bring about a more profound glucose lowering effect than dietary counselling alone suggesting that probiotics may be of particular importance.”

Among this study’s methodological shortcomings was that it wasn’t double blinded. When researchers know which particpants are on a study drug, subjective outcome measures are more difficult to interpret. There was also no documentation that exercise was controlled for, even while looking at body composition measurements.

Only selected data was provided on body measurements, biceps skin fold thickness and waist circumference, and no pre-pregnancy measurements were reported, making credible conclusions impossible. Average bicep skinfold thickness measurements were only given for 1, 6 and 12 months postpartum. All of the measurements were higher at six months and lower at 12 months, but the differences were miniscule and all of the changes seen during postpartum were less than the standard deviations:

● The probiotic group went from 1.03 cm to 1.08 cm at one-year postpartum. Their skin fold thickness was 0.05 cm higher one year after delivery.

● This compared to a 0.02 cm reduction seen in both the placebo/diet and control groups.

In other words, the skin fold thickness changes seen during postpartum differed between the probiotic and nonprobiotic groups by biologically meaningless amounts. It was the same story with the waist circumferences, only the data provided was even skimpier. With only the 6- and 12-month data reported, the changes seen among the groups differed by only half a centimeter.

When we see beyond the media’s coverage of a press release of a 15-minute presentation at a conference, “science by press release” marketing becomes a lot clearer.

The sad thing is, most consumers take all studies as being equal and when they hear that new research by a team of scientists found something, it’s natural to believe it is true. And people so want to believe that eating some special foods or taking some supplement can prevent obesity or chronic diseases of aging and help them live longer. But that isn't true.

© 2009 Sandy Szwarc

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

You can trust us with your most private information — May 4, 2009

“The Virginia Department of Health Professions is currently experiencing technical difficulties which affect computer and email systems. We apologize for any inconvenience this may cause.”

“We hope this information is helpful to you and we sincerely regret any inconvenience this may cause you.” — H. Alan Rosenberg, LexisNexis Vice President, Investigations and Incident Response

Last Monday, 8,257,378 patient records and 35 million prescriptions were reported as stolen from the Virginia Dept. of Health Professions. An extortion note was posted on WikiLeaks, an online clearing house for leaked documents, demanding $10 million to return the prescription records to the State. Patients who went to the Virginia State website used by pharmacists, found the site down with the above “technical difficulties” message.

This didn’t make much news, perhaps because that would have meant it was news.

But security breaches of electronic records have become commonplace, as have extortion demands like this, reported InformationWeek. Last October, for instance, we watched as the pharmacy benefit manager, Express Scripts, received a similar extortion letter threatening to release millions of patient records unless the company ponied up. And last December, Cedar-Sinai hadn’t even been aware that its electronic medical records had been stolen and were being used for fraud, until hospital officials were alerted by prosecutors.

The same day news of the Virginia Dept. of Health Professions security breach came out, some 32,000 people received a letter from LexisNexis (I can show you mine), telling them that their sensitive personally identifiable information had been breached and that it had been contacted by the United States Postal Inspection Service (USPIS) about an ongoing investigation into alleged credit card fraud perpetrated by former customers of LexisNexis. The unauthorized use of customers’ personal information occurred between “June 14, 2004, and October 10, 2007, and the information accessed may have included your name, date of birth, and/or social security number.” People were just being notified that their personal information had been compromised two to five years later, and after up to 300 people had been victimized by a fraudulent credit card scheme that racked up charges on their credit cards, as well as set up fake credit cards in their names. CBS News reported that it’s linked to a Nigerian Scam artist.

This wasn’t the first security breach by people operating businesses with LexisNexis or its ChoicePoint customers, either. LexisNexis had disclosed in 2005 that hackers had gained access to the personal information on 32,000 people in its database. ChoicePoint is a spin-off of Equifax and had been acquired by LexisNexis in 2008. It also has a history of data security laxes and had gotten in trouble with the federal government in 2005 for selling reports on about 160,000 customers to identity thieves. ChoicePoint settled with the FTC and paid fines of $10 million in civil penalties and $5 million in consumer redress.

In fact, the problem of securing private information is growing dramatically, according to Identity Theft Resource Center^®, a nonprofit organization dedicated to education and prevention of identity theft. The number of cases of data security breaches in 2008 were 656 — a 47% increase over the 446 in 2007. And that represented a three-fold increase over 2005, when there were 158 incidences, affecting more than 64.8 million people. The problem is growing worse, not better.

According to the ITRC, nearly a quarter of breaches (24.5%) occurred from government agencies, another quarter from educational institutions and 14.5% from healthcare facilities. Its 2009 Breach Report already has a dizzying number of breaches — 37 pages with 170 breaches affecting 2,802,655 people. For example:

Federal Aviation Administration (45,000 employees), Oklahoma Dept. of Human Services (1 million people on Medicaid, WIC and other services), Ohio Dept. of Public Safety, Warrior Express, Marian Medical Center (3,200 patients), Washington State Dept. of Labor and Industries, Oklahoma Employment Security Commission (5,500 employees), New York State Dept. of Taxation and Finance, Atlas Collections, DFS Capital Funding, WalMart, Valeta School District, McAllsters, Penn State Erie-Behrend College (10,868 records), CBIZ Medical Management Professionals, Peninsula Orthopaedic Associates (100,000 patients), Moses Cone Memorial Hospital (14,380 patients), Tennessee Dept. of Education (18,541 students), City of Lawrence School Dept., Hawaii Dept. of Transportation, University of Washington (6,000 employees), Culpeper Taxpayers (7,845 taxpayers) Tennessee Dept. of Human Services Policy Studies (1,600 people), Maryland State Employees SHPS Human Resources (8,000 employees with health savings accounts), Palo Alto Medical Foundation (1,000 people), Metropolitan Insurance, LifeWatch, Massachusetts General Hospital, Ohio Dept. of Administrative Services, Sam Houston State University, Maryland Federal Court, Solano Community College, Jackson Memorial Hospital, NYC Housing Authority, Walgreens Health Initiative (28,000 retiree pharmacy records), University of West Georgia, Oklahoma Dept. of Human Services, NYC Office of Payroll Administration, FEMA, Agape Healthcare, St. Rita’s Medical Center, NYC Policy Dept. Pension Fund (80,000 policemen), Western Oklahoma State College, Pennsylvania State OPP (10,000 employees), United Healthcare Workers West-Kaiser (29,500 patients), City of Muskogee (4,500 people), Steamboat Springs School District, Children’s Hospital Boston, Arkansas Dept. of Information Services (807,000 records missing), University of Alabama Health Facility (17 computers with 37,000 patient lab records), Rio Grande Food Project (36,000 clients), University of Florida-Grove (97,200 records), Idaho National Laboratory (59,000 employees), Kaiser Permanente HMO (30,000 patient records), Indiana Dept. of Administration (8,775 people with worker compensation or disability claims) ….

Before this post was finished (I got side-tracked filing all of the fraud alerts and stuff), the University of California-Berkeley's health services center was notifying people that its computer database had been hacked and 160,000 records with social security numbers, health insurance information and nontreatment medical records (such as records of physicians seen for diagnoses and treatment, immunizations and screening tests) may have been stolen. The breach is believed to have begun last October 9^th and gone undetected until April 9^th, when maintenance administrators discovered messages left by hackers from overseas.

As more information is placed on electronic databases, risks for security breaches skyrocket. In 2008 alone, the ITRC reported 35,125,425 records of personal identifying information were breached from electronic records — 98.4% of all breaches of private information — compared to 565,830 breaches using paper records (1.6% of all breaches).

Am I the only one who has noticed that the very people who told us that electronic voting machines can’t be hacker-proofed are now telling us that electronic medical records will be perfectly safe and secure? — HealthcareBS.com

Security isn’t the only unsupported claim the public has heard about the new nationalized integrated electronic medical record system. Few people really understand that nationalized means centralized for federal government oversight (of both them and their doctors’ behaviors) and integrated means automatically populated from pharmacy, lab, diagnostic, hospital, clinic and medical records systems, and interconnected to ensure uninhibited sharing of information among all stakeholders and federal agencies. Imagine how people would feel if they knew that stakeholders and government officials believe Americans have no Constitutional right to informational privacy, leaving them “with a right in progress” to people’s personal information, and that stakeholders know that with the system they envision, security breaches will increase. Yet, the public is told to trust the government to protect the privacy and security of their information. It's reminiscent of that quote:

The most terrifying words in the English language are: “I’m from the government and I’m here to help.” — Ronald Reagan

© 2009 Sandy Szwarc

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

Pudge Police Coming — Part Two

Part One here.

North Carolina legislators voted to use discrimination to help bail out the State’s Health Plan. As troubling as that sounds, the legislation passed without much trouble, perhaps because it’s been easy to convince the public that certain people are costing them and to blame for having health problems.

Last week, the North Carolina State Auditor’s Office released its audit of the State Health Plan, entitled Performance Audit, NC State Health Plan FY 2008 Projected vs. Actual Results. The Beaufort Observer editors summed it up: “It is disgusting, to say the least.”

“The bureaucrats’ math in doing the projections was off by $137.6 million,” they reported. The state had signed a contract with Blue Cross and Blue Shield for a managed PPO type of plan (Preferred Provider Organization) with its “North Carolina HealthSmart wellness programs” that were supposed to make the state money ($57.9 million). As we know, these health management plans — focused on preventive wellness, risk assessments [risk factors do not mean risk] and disease management using their clinical guidelines; and with providers working under P4P (pay-for-performance) mandates — have not been shown to improve people’s health outcomes and have been shown to actually cost more and raise administrative costs.

Sure enough, the plan lost $79.7 million last year.

As the Business Journal explained, “increased claims and administrative expenses cost $200.1 million more than planned, wiping out $62.5 million in revenue over budget.” The PPO plan, started in 2006, was marketed as being less expensive because of discounts negotiated with providers. But as more State Health Plan members enrolled in the PPO plan, they used more medical services. The legislators who had instituted the State Health Plan’s contract with BCBS had also underestimated administrative expenses by $36.3 million. North Carolina’s General Assembly has had to dip into the state’s reserve funds to cover the plan’s growing losses, said the paper.

Last week, as the Sun News revealed, one of the ways the state has responded to its public health insurance boondoggle is a proposal to “peg the state’s funding for local health departments on benchmarks local officials say they can't control.” Brunswick Health Director Don Yousey explained that the state now plans to tie local public healthcare funding to each county’s incidences of tobacco use, obesity and diabetes. In other words, if there are more fat people, smokers or diabetics in a given county than the state allows, funding would be withheld.

How welcome in their communities do you think people with these risk factors will become, as local governments see them taking money from their coffers? Medical professionals know that the people who will be most targeted will be the aging, those with certain inherited traits and those of lower social-economic status. These are the people increasingly seen as less deserving of healthcare because of myths that any health problems they have are self-induced and were preventable.

The legislators had not consulted commissioners from the health department, the Sun News reported. Commissioners said they are concerned that linking funding to certain benchmarks will have the same outcomes the last time the government tried that with mental health services: patients have been forced away from local care to large regional state treatment facilities, and those who need care have not been able to get it.

The second half of the discrimination equation being used to try to bail out the state budget has already been activated. The News Observer reported that legislators recently adopted its State Health Plan bailout bill. It calls for specific “wellness provisions” that will, for instance, charge fat people and smokers more by forcing them into more expensive insurance plans. “The first step in the wellness program is to shift every State Health Plan enrollee into the most expensive insurance coverage option — the so-called ‘basic plan,’” said Adam Linker, with the N.C. Justice Center’s Health Access Coalition. “The burden of proof is then on the employees to verify that they, and all of their family members, are properly proportioned nonsmokers.”

Verification in hand, employees then earn the right to move back to the less expensive insurance coverage option known as the "standard plan." This is an administrative train wreck waiting to happen. The insurance enrollment process is confusing and chaotic enough without juggling families back and forth between health plans. But let's suspend disbelief for a moment and assume that administration and enrollment go smoothly….

[T]o ensure that none of those crafty state employees tries to sneak a cigarette, the State Health Plan will subject all enrollees to random blood and breathalyzer tests. Plan officials will conduct the random tests… The bill also authorizes plan officials to dream up additional punishments for employees caught lying about their smoking status. In 2011 the State Health Plan will institute a similar program to punish those with body mass indexes, in the words of the bill, “within a range determined by the Plan” based on undefined “clinical guidelines.”

Think about that for a moment. In order to receive affordable health care paid by the government, the State will force you to submit to blood, urine and breath tests to measure your health indices and monitor your compliance with what it determines best.

North Carolina is following the example of the Japanese government and its health ministry’s compulsory blood tests and “flab checks” for older workers, with BCBS taking the lead to impose similar mandates here. Japan’s mandatory health assessments were purportedly to identify those with metabolic syndrome (“metabo”) and charge stiff penalties to those who fail to conform, most notably older and naturally heavier people. More than half of all adults will be hit with penalties under Japan’s metabo campaign, which is said to really be part of efforts to shift costs of Japan’s failing government health care program to the private sector.

As we’ve seen, the preponderance of sound medical evidence and objective population data continues to show that these health indices are not measures of health or risks for chronic disease (from diabetes, cancers to heart disease) or premature death. Nor are they measures of those eating right, exercising or following healthy lifestyles.

No body measurement is. Instead, they are primarily indicators of aging, as well as genetics and social disadvantage, and hence discriminatory.

Today’s intense marketing of lifestyle medicine and preventive wellness has popularized beliefs that chronic diseases are people’s own fault and could have been prevented by 'healthy' diets (defined differently depending on the source) and lifestyles. The results of every major randomized, controlled clinical trial of healthy eating and lifestyles to date, however, have failed to demonstrate credible benefit in preventing chronic diseases of old age (like the big three diabetes, heart disease or cancers) or in living longer. Nor has any healthy eating intervention been shown to give everyone a government-approved BMI.

Achieving and maintaining the low metabo numbers now being required by third-party payers can only be achieved by profitable prescription medications, for nearly all older adults, and increasingly radical weight loss measures, none of which have ever been proven to improve actual health outcomes, but to put people at increased risks.

The only way that lifestyle medicine has been able to achieve such popularity and why these compulsory interventions and penalties aren’t immediately apparent to everyone as discriminatory, is because of today’s widespread lack of scientific literacy. That’s simply how to think and reason logically.

Such discrimination can be made to seem appropriate when society has a poor understanding of science and credible information, and when it comes to believe that certain people are less deserving of healthcare.

As the paper points out, no other state has such far-reaching “wellness initiatives” and Alabama has the only law on its books charging a fee for obesity. This will only hurt people — fat, elderly and poor people most of all. “Health researchers know that if a state employee is suddenly required to pay steeper deductibles it will likely deter him from seeking needed medical care,” Linker pointed out, adding:

State Health Plan officials and legislators claim they want to save money and improve the lives of state employees by showing them tough love. The problem is that state actuaries have not predicted any savings from these ill-defined wellness programs.

Even under the rosy assumptions presented by the plan’s director, they might only break even in three years, he wrote. But that’s not likely to happen, either, because these wellness programs aren’t based on sound science to begin with and have never been shown to improve actual health outcomes or reduce healthcare costs.

Had Joseph Goebbels, in the 1920s, correctly pegged people as easily manipulated by media disinformation campaigns, groupthink and fallacies of logic? Without an understanding of sound science, discrimination can be made to seem acceptable and “for their own good” … and for the greater public good. Societies have been down this road before, with tragic consequences for humanity. People didn’t see then until was too late. That’s why science is more important than ever today.

© 2009 Sandy Szwarc

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

Innocence lost — health messages are not always healthful

The current focus on teaching children “healthy” eating is popularly believed to be so healthful, helpful and necessary, that confirmation bias cannot let us see the evidence that suggests it isn’t. A major 3-year study found disturbing clinical evidence that children are being harmed by such initiatives… children as young as five. Yet, not only has the media not widely report this important study, even its authors missed the biggest story in its findings.

What was reported

A small troubling piece in the Australian news reported that children as young as five are suffering from eating disorders and being hospitalized with life-threatening malnutrition. They are “literally starving themselves to death.”

Dr. Sloane Madden, child and adolescent psychiatrist at Children’s Hospital at Westmead, Sydney, said that they’ve seen a 50 percent increase in children aged 10-12 and younger needing hospitalization for eating disorders, an increase not seen among older teens.

These young children are critically ill by the time they arrive at the hospital, he said, and are medically unstable, with very low blood pressure, heart rate and temperature and are so malnourished they need tube feedings. In fact, he said, during the three years of their study, children were in increasingly critical condition by the time a diagnosis is made. That’s a concern because it means that disordered eating is going undiagnosed until children’s health and lives are in danger.

According to Dr. Madden, the children say “they believe they are fat and want to be thinner, and they have no insight into the fact that they are malnourished and they are literally starving themselves to death.” “The number of cases is expected to rise,” Dr. Madden said, “unless there is a change in the media's obsession with fat and weight.”

Because of the way the study was reported, it might have been easy to dismiss it. Readers may have thought that it was the experience of a single medical center offering pediatric anorectic services and a matter of more children coming to their center, not a nationally representative trend. But that wasn’t the case.

The study

The study, published in the Medical Journal of Australia, reported the findings of the first national prospective study of early-onset eating disorders (EOEDs) in young children. It was based on active surveillance data from the Australian Paediatric Surveillance Unit from July 2002 to June 2005, which gathered data from physicians, primarily paediatric Fellows of the Royal Australasian College of Physicians, of all Australian children aged 5-13 years who had received a diagnosis of EOED. The definition was developed in consultation with paediatric EOED specialists, and “was based on existing diagnostic criteria from the DSM-IV; the International classification of diseases, 10th revision (ICD-10); and the Great Ormond Street Hospital for Children Feeding and Eating Disorders Service.”

The authors from Children’s Hospital at Westmead, the Department of Paediatrics and Child Health at the University of Sydney and the Australian Paediatric Surveillance Unit in Sydney received detailed reports on a sampling of 101 children, about 90 percent of those diagnosed with EOED. What may be surprising, they found “no significant differences between boys and girls in terms of age, presenting symptoms, psychological comorbidities, family history or outcome.”

Eating disorders are most recognized as beginning during adolescence, the authors noted, when they’re the third most common chronic illness in women. “Eating disorders have the highest lifetime mortality rate of any psychiatric disorder (up to 20%), and mortality rates are 12 times higher for women with eating disorders than for unaffected women,” they wrote.

Children with eating disorders, however, continue to get younger. It was only in 2003 that Australian news had reported that the average age of young people being hospitalized for eating disorders across the country had dropped from 14 years in 2001 to 12.

In this study, three out of four young people diagnosed with eating disorders were female and the average age was 12.2 years. But nearly one in five patients were under the age of ten.

Disordered eating in young people and teens who are still growing puts them at special risk of complications that can have serious implications for their health and futures, such as “growth retardation, impaired bone health, cognitive impairment, disruption of pubertal development, infertility, depression, anxiety and death,” the authors noted.

How myths can be deadly

Of those children who had to be hospitalized, nearly two-thirds (61%) had life-threatening complications of malnutrition, yet only 37% had met the DSM-IV official diagnostic criteria of anorexia nervosa. The most significant failure of the commonly used definition of anorexia nervosa was that half of children suffering disordered eating — so severe that their malnutrition was even life-threatening — appeared ‘overweight’. Weight is a poor measure of eating disorders or health. Only 51% of those hospitalized and 23% of outpatients were under 85% on the BMI growth curves. As we’ve seen, failing to understand the natural diversity among people and believing the myth that fat people are fat because they overeat, means that children who are seriously below a weight that’s natural for them and who are failing to grow and develop normally per their individual growth curves, can look fat or even a ‘normal, healthy’ weight. You cannot tell from looking at people which ones are starving.

“Our study also highlights the absence of a threshold body weight or body mass index in children below which medical compromise occurs,” Dr. Madden and colleagues wrote. They cautioned that any young person who is falls off his/her growth curve should be taken seriously. Rapid weight loss is more likely to result in life-threatening complications. Of the young people who required hospitalization, nearly all of them had lost weight (89%) or failed to gain weight (8%), “as would be expected during normal growth,” the authors reported.

Among the young people diagnosed with eating disorders, half of which were potentially life-threatening, about three-fourths (74%) presented with fear of gaining weight or of being fat and preoccupation with their weight (73%).

But to believe that eating disorders are just about fat and weight is to miss the much more serious findings in this study — findings with wide implications: how today’s “healthy eating and physical activity” messages, largely driven by the war against obesity, are affecting young people. Yet, even the authors didn’t see them.

“I think that there needs to be a move away from this focus on weight and numbers and body fat, and a focus on healthy eating and exercise,'” Dr. Madden told reporters.

The study, however, found that compared with weight and fat, far more children were preoccupied with food and trying to avoid eating foods — foods they believed were unhealthy or feared were bad for them or would make them fat — 98% of these young children were avoiding foods and 90% were preoccupied with foods. Another worrisome finding was that more than half of the youngsters (54%) were already exhibiting excessive exercise, another anorectic behavior.

This study provided important indications that the incessant messages being given to children about healthy eating and exercise to prevent obesity are having serious adverse consequences. The evidence certainly provides no support that children need more of the same. Yet, the belief in healthy eating and activity has become so strong, the cognitive disconnect isn’t recognized. This is an example of one of the most common fallacies of logic, known as confirmation bias.

The evidence not seen through the cognitive disconnect

This study is not the first to suggest that healthy eating and activity interventions to address an “epidemic of childhood obesity” are not only groundless, but harming young people. The largest, most comprehensive statewide program ever enacted in our country, the Arkansas Act 1220, is one such example of a program that has failed children.

Confirmation bias doesn’t just lead advocates to design evaluation tools to support what they believe, or want us to believe, is true, but to report the findings in such a way, too. As we saw last fall, when the fourth annual report of the Arkansas 1220 was quietly released, this immense program was shown to have had no effect on children and adolescent weight classifications and to have failed to demonstrate improved health outcomes. Meanwhile, troubling evidence of its unintended consequences is growing. The results of this major healthy eating and activity intervention for children showed the importance of not looking at what we are teaching children, but what they are learning.

Beginning with children’s programming and Saturday morning cartoons, toddlers and preschoolers cannot escape the nonstop barrage of ‘eat right and exercis’ messages. They proliferate on Nickelodeon’s “Lazy Town,” PBS' “Boohbah” and the Disney Channel's “JoJo's Circus.” Ronald McDonald is pushing fitness and even the Cookie Monster on Sesame Street and Barney tells kids about eating “right” and that his favorite treat should only be a “sometime food.” Children’s programming is filled with examples of fat children being ridiculed. The messages to eat healthy and be active to prevent child overweight become even more pronounced once they start school.

Child nutrition and eating experts have been cautioning for years that even “positive” nutritional messages are beyond children’s understanding and disregard their developmental ability to grasp the complexities or to apply such concepts as “moderation.” Children are black-and-white thinkers and when they are told sweets or fats should be “sometimes foods” and eaten in moderation, they take that to mean all sweets or fats must be bad. By 1995, for instance, more than eight out of ten American children, aged 9-15, already believed healthy meant avoiding all high-fat foods. And a recent British Heart Foundation poll of 1,100 UK children, 8- to 15-years old, reported that a quarter of the youngsters believed “bad” foods would shorten their lives. And nearly half of the kids polled said they believed that ‘junkfood’ would make them fat and unpopular, cause their teeth to decay and their skin to break out.

According to the research of international child nutrition and eating expert, Jennifer O’Dea, MPH, Ph.D., from the University of Sydney in Australia, health education messages and government dietary guidelines since the 1970s, with their “control your weight” messages, have resulted in an exponential rise in disordered eating and most young people have mistakenly come to believe that they are eating “healthy,” when they are actually dieting. Food fears and unsound beliefs about healthy eating continue into adulthood, with many suffering lifelong disordered relationships with food.

Yet it’s been recognized for decades, such as research from the Centre for Adolescent Health at the University of Melbourne, Australia, that restrictive eating and dieting behavior among girls is associated with five to 18 times greater risk of developing an eating disorder. So, the increase in eating disorders seen among children exposed to increasingly intense healthy eating and exercise messages should not really be a surprise at all.

Saddest of all, is that children have never grown up in a safer world. — Most have enough to eat, safer foods and better diets, not nearly as bad as some are trying hard to convince us to believe. They are as fit and active as ever. They have better access to medical care and immunizations that have enabled far more to survive infancy and childhood; and far fewer to spend their childhoods sickly, with childhood illnesses, foodborne illnesses and nutritional deficiencies. Children are healthier and have the longest life expectancies of any time in our history. There is no credible science that the diets of today’s children are shortening their lives or causing them to develop adult diseases. There is no credible scientific support that low-fat, low-sugar, low-salt foods define healthier foods for youngsters, prevent heart disease or obesity, or lead to longer lives. [Background: here, here, here, here, here and here.]

This should be the best time to be a child. Instead, today’s young people are surrounded by scares about their foods, their bodies, their futures and the world they live in. Kids as little as five years old are being hospitalized for starvation because they’re afraid to eat. What is wrong with this picture? When will adults see past their own biases and the special interest scare mongering, and see what is being done to their children… and give kids back their childhoods?

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

The faces of child obesity

Australian parents are realizing that they’ve been deluded about an epidemic of childhood obesity. Lesson One — Never forget to ask the most important question of any health statistic: How is it being defined?

It’s easy to lie with statistics, graphs and scary marketing, and even to get people to believe the opposite of reality, such as in an epidemic of obese, unhealthy and sedentary children. As alarming claims are repeated and the most extreme examples are depicted as representative of the crisis, few people stop to question how a statistic is being defined.

With today’s new definition of “overweight” (children ≥95^th percentile on new BMI growth curves, also called “obese” depending on the author), a mere 5 pounds makes the difference between a first grader being labeled as “normal” or “obese.” Even doctors are unable to recognize the children who meet the definition and few people understand what most “obese” and “overweight” children really look like. If they did, of course, they’d realize how incredible the claims of a crisis really are.

In The Australian, Richard Guilliat profiled a perfectly healthy, typical “cherubic first grader” who had been subjected to a government health check in school, where her BMI had been assessed. Her parents had been notified by the health department that she was overweight and suggested the family come to the local health centre to have their family’s eating habits and physical activities analyzed and participate in a “Talk about Weight” group session.

As Guilliat explains, parents who recognize that their own children don’t match the depictions of childhood obesity, or the “fat and unhealthy” labels being placed on them by health officials, are increasingly questioning the obesity “epidemic” being “touted as the greatest health crisis facing the western world.” For years, we’ve heard the dire warnings. “Our children are said to be a generation of bloated couch-potatoes destined for a life of clogged arteries and diabetes,” he wrote. “Obesity could rival smoking and the Black Death as a killer, according to high-profile overseas experts.”

Although the sound scientific evidence fails to support the scares, so do parents’ own eyes. These parents have begun to think critically and question the hype of an epidemic. They’ve taken the first step. Next, they have to examine what they’ve been led to believe about what healthy children look like, the deadliness of fat and the natural variation of sizes among children.

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

An acronym that explains a lot of things!

A financial publication isn’t a place you might expect to find an insightful article on health, but Financial Times proved the exception. Last weekend, Stuart Blackman explored how seemingly helpful educational health messages can be bad for our health. In fact, they can lead us to believe we are unhealthy and to actually feel quite unwell.

His article, “Why health warnings can be bad,” began by describing the nocebo effect. That’s the powerful phenomenon of developing the most extraordinary physical symptoms when we believe or fear that something is bad for us. It’s the negative stepsister of the placebo effect and the full significance of both isn’t understood by many people. The nocebo effect is behind the confirmation for most food fears, for example. People who’ve been taught to believe certain foods are bad for them actually feel sick, experiencing such things as headaches, chest pain, nausea and indigestion, rashes, cough, congestion, weakness and fatigue, and even paralysis when they believe they’ve eaten them. It’s the stepsister of the placebo effect, at work when we feel healthier after eating foods or taking dietary supplements we believe are healthy.

Even simply reading about scary diseases triggers the nocebo effect, such as the well-known syndrome among students reading medical textbooks who self-diagnose their benign symptoms and become convinced they are sick with exotic diseases. Yet, look how much medical information is on the internet and surrounding all of us in newspapers and magazines today! According to Blackman, research is accumulating that the nocebo effect may be behind a host of 21st century ailments*.

“Some experts are concerned that the situation is being compounded by the efforts of health professionals to raise awareness of threats,” he writes. When we hear that something could be bad for us, has side effects or puts us at risk for health problems, we start looking for signs of illness.

And we’ll probably find some, says [Brian Hughes, a psychologist at the National University of Ireland, Galway], even if the pill is a dummy one or the electric field a sham. That is because unpleasant physical symptoms are a normal part of life for perfectly healthy people. Headaches come and go. Some nights it is hard to get much sleep, and some days it is difficult to keep our eyes open. We might feel light-headed one moment and in a bad mood another. These are all experiences that we would not think twice about were we not looking for signs that things are wrong. But when we are looking, it is easy to interpret a bad night’s sleep as insomnia, tiredness as fatigue, light-headedness as dizzy spells or a bad mood as depression – and then to reattribute those symptoms to whatever it was that we expected to harm us. And once we start believing that something is making us ill, we get anxious, which can itself exacerbate existing symptoms or induce others…

As Arthur Barsky, professor of psychiatry at Harvard Medical School, said, when “you induce negative expectations – whether it’s through a pill, a health warning or advertising by a drug company – you set in motion the same process of symptom reattribution, which then amplifies the symptom, which further solidifies the reattribution.”

According to John Adams, professor emeritus at University College London and Britain’s leading risk expert and author of Risk, a major contributor to our negative expectations is the popular trend among health professionals and health agencies to issue precautionary advice concerning health risks, even when there is no evidence for any credible risk to people’s health. He labeled it a “syndrome” he calls C.R.A.P.

I discovered CRAP recently when I was invited to speak to a conference of psychiatrists. They, like the rest of the medical profession, practice defensively, and labour under incessant demands for the assessment of the risks of everything they do. I boasted that I had found a new mental disorder called compulsive risk assessment disorder. One of them volunteered that the condition I was describing they would call a psychosis - a mental disorder in which contact with reality is lost or highly distorted. Certainly Compulsive Risk Assessment Psychosis produces a more compelling acronym.

As we’ve seen, being surrounded by people, news and information that reinforces our fears about unseen dangers in our food, bodies or exposures can escalate our perceptions of risks, far beyond any credible danger, and let our minds run wild. Soon, we’re afraid of practically everything … and feel increasingly sickly. Thinking too much about health doesn’t make us healthier.

Fear sells

Fear is a well-known marketing technique, yet few people realize how often it’s used. No one profits from quelling fear and giving us the facts that we’re healthier and living longer than ever in the history of humankind.

Fear-based marketing is often presented as health education or health advice. You can tell the difference, though. Once you understand what makes sound science and fair tests of hypotheses, the scare mongering and junk science — “what-if” speculations, biologically implausible arguments, subjective or anecdotal evidence rather than biological/clinical outcomes, flawed and misleading research methodology, and untenable findings — quickly stick out like sore thumbs.

Today, even the normal human condition and our natural diversity is being medicalized. As Dr. Nortin M. Hadler, M.D., professor of Medicine and Microbiology-Immunology at the University of North Carolina, Chapel Hill and rheumatologist, wrote in a recent Journal of Rheumatology:

If questioned closely, nearly all of us can recall low back pain last year, a third of us recall pain at the shoulder, hand or wrist, and 15% of us at the elbow. These memorable episodes last at least a week and often are recurring. Regional musculoskeletal pain is an intermittent and remittent predicament of normal life... These challenges are as much a part of life as heartache, heartburn, headache, and the like.

Yet fear marketing can take advantage of the nocebo effect and use everyday normal aches and pains to frighten people into believing they have real health problems.

Dr. Hadler and professor Adams are not alone in cautioning that health warnings about health risks, including our obsession with health screenings and tests to monitor health risk factors, are teaching people to be patients and leading to growing numbers of those who doctors call “the worried well.” Even healthy little kids are being taught to worry about getting adult diseases of aging. Fat children and adults, for example, live under the constant threat of being told that their size is a death sentence.

Being health conscious versus one of the worried well is an increasingly tenuous distinction. The worried well not only lose their sense of well-being, they seek more tests and visit clinics and doctors more often, accounting for one-third of all primary care visits, and incur healthcare costs 14 times higher than average.

The preventive health movement, concerns over health risk factors, and being inundated by health information has also changed our very concept of what it means to be healthy. We’ve come to believe that we must be continually diligent and get regular medical attention to stay well, rather than realize that most of us are healthy most of the time and only occasionally get sick and then get better again. David Wainwright said: “Health policy is promoting this belief that we’re all at risk from absolutely everything we come into contact with, and that just encourages us to feel more vulnerable and to interpret our normal experiences as health problems. It’s all just amplifying this epidemic of non-specific illness, which has incredibly disabling effects on people.”

It’s not the diseases of aging which actually kill us that are rising — in fact, their rates are dropping and we’re actually freerer from the serious illnesses our grandparents faced. Yet, we are more worried about our health than ever before. As Blackman wrote, the concern of these scientists “is the rise of conditions such as back pain, fibromyalgia (chronic fatigue syndrome) and food allergies, which are characterized by the symptoms expressed rather than by the underlying biology.”

These symptoms may have a biological basis in some individuals and a psychological one in others. So, while rare and tragic deaths resulting from extreme food allergies can be attributed to physiological anaphylactic shock, health warnings on food that “may contain nuts” might be contributing to the rise of food allergies in general, and to the statistics that less than 20 percent of teenagers who believe they have a food allergy actually test positive.

Food labels, product warnings and health information accentuate this focus on fear. “I think it’s become a kind of hysteria,” said Dr. Barsky. And the downfalls are appearing to outweigh the upsides, as people’s confidence in conventional medicine and food production is undermined, which can create its own nocebo effects and lead people to place increasing faith in alternative modalities. If they don’t watch out, wrote Blackman, health professionals and policy makers could find themselves becoming the target of lawsuits over their health warnings “on the grounds that it exacerbates illness through the nocebo effect.” At least, he said, the plaintiffs “would have some scientific evidence to support their claims.”

© 2009 Sandy Szwarc

*Disregarding his example that our body type and weight is under the power of suggestion, sigh...

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

All of humanity under threat…

There are now nearly 2.3 million news stories on Google News about swine flu. The World Health Organization is now backing off it’s pandemic rhetoric and reports a total of 19 people worldwide have died from this particular strain of the flu, all from Mexico except for one child from Mexico who died in a Houston hospital in the United States.

Despite last week’s exaggerated death count speculations in the media, Mexico’s health secretary Jose Angel Cordova admits the virus isn’t as lethal as feared and Dr. Nancy Cox, director of the CDC’s influenza division, again tried to tell the media this morning that even preliminary genotyping of the virus had suggested there was no support for comparing it to the 1918 flu pandemic. (Her cautionary notes, once again, didn't make the official stance on the Sunday talk shows.) This newly tested for strain of the flu appears less lethal than the common flu, just as other swine flu strains have proven to be for decades.

Yet the priorities of governments and media highlighted that the swine flu hysteria is not really about sound risk assessments:

More than 433 public school in the United States had closed over swine flu fears as of Friday, and graduation ceremonies have been cancelled, with diplomas being mailed.

Only one school system in the entire United States, Maricopa County Valley schools in Arizona, has reopened its schools. On Saturday, Maricopa County Public Health Director Bob England, said such drastic containment measures aren’t necessary because medical evidence suggests that the swine flu virus is no more virulent than common influenza strains, which kill more than 30,000 every year. “Frankly, this virus doesn't warrant that. It ain't that bad,” he said. “It's just a regular flu with a fancy name.”

New York City cancelled Cinco de Mayo, the festival is popular with Mexicans and organizer Carmelo Maceda said they “couldn’t afford to take a chance” and risk the “contamination of thousands of thousands of people.”

Proms, concerts, sporting events and church services across the country have been canceled.

Chinese authorities have confined nearly 70 asymptomatic Mexican business and tourist travelers, keeping them hostage in hotels in what is being described as unacceptable conditions and government discriminatory action.

President Obama told the public that his administration was “making every recommendation based on the best science possible” and was taking aggressive action. “Out of an abundance of caution,” the government requested another $1.5 billion in funds to buy more antivirals and for the development of a swine flu vaccine. That’s on top of $156 million already appropriated in March for pandemic influenza research and $6.1 billion previously earmarked for flu pandemic preparedness. What many found disturbing is that the government is actually considering sacrificing some of the 30,000-50,000 Americans who die each year of the seasonal flu to pay pharmaceutical companies to divert their resources from producing their usual winter flu vaccine to a vaccine for swine flu.

Dallas Morning News reports concern is growing within the Mexican community, which is poorer and where families have less access to health care, that they could face continued discriminatory backlash. Community leader, Jorge Navarrete, said the bashing of Mexican immigrants is wrong: “The virus isn’t going to distinguish between Anglo, Mexican or African-Americans.”

Reuters reports that Egyptian police fired tear gas on Sunday at garbage collectors who pelted them with rocks and bottles over fears they had come to seize their pigs as a precaution against swine flu and at least ten people were injured. Egypt, which Reuters reported was “already hit hard by bird flu,” had ordered the slaughter of all 300,000 to 400,000 pigs in the country on April 29 as a precaution. The number of cases of swine flu in Egypt, according to the WHO: zero. Not even a single suspected case. According to journalist Pierre Tristam in an article titled “Swine Flu Unleashes Epidemic of Prejudice,” the pig farmers are Coptic Christians, a minority in the Muslim country and often victims of prejudice.

While a strain of influenza has resulted in 19 deaths worldwide — the world’s greatest disease, malaria, kills 1.5 to 3 million every year — one person every 12 seconds; 3,000 children a day in Africa alone — mostly killing poor people in Africa. Malaria afflicts more than 2,400 million people around the world, over 40% of the world’s population, in more than 100 countries, including 1,324 cases in the United States, according to CDC 2004 figures. WHO statistics show a 16% growth in malaria cases each year, yet the entire world combined has spent only $58 million on malaria research.

In contrast to about 2.3 million news stories about swine flu on Google News, how many news stories have there been about a malaria pandemic?

Two.

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

Swine Flu update: April 29, 2009

Part One of the Swine Flu epidemic here.

By the end of the day, panic over swine flu had reached pandemic proportions, with more than 117,607 news stories appearing on Google News. As media professor, Robert Thompson, at Syracuse University in New York, told Reuters this morning: “If as many people had swine flu as those [in media] that are covering swine flu, then it would be a pandemic to reckon with.”

He was more right than readers realize. As of tonight, the World Health Organization’s Swine Influenza Update reports 91 confirmed cases of the swine flu in the United States and one death; while Mexico has 26 confirmed cases, including seven deaths.

117 cases

117,607 news stories

That’s 1,005 news stories for each case of the flu.

It’s been heartbreaking to realize how many people have become truly frightened by the news stories. For consumers trying to find balanced information in the news, they’re encountering similarly overwhelming odds. But there have been tiny droplets of science and sense coming from experts that you can find — if you have time to wade through a thousand panic stories to find each one.

Death has come to the U.S.

The first U.S. death to swine flu instantly became all the proof needed to raise the panic bar about the threat of swine flu for our children and lead to schools being closed across the country.

What hasn’t been widely reported is that the 23-month old boy who became the first U.S. death to swine flu was from Mexico and had undisclosed “underlying medical problems.” He had been airlifted to Texas Children’s Hospital in Houston in critical condition. “While tragic and alarming, the case does not prove that the recently emergent virus has established a foothold in Southeast Texas,” health officials cautioned in the Houston Chronicle. “The boy was isolated in a hospital environment that made transmission of the virus unlikely, and no one in his family has exhibited symptoms.” As Dr. David Persse, Houston’s emergency medical services director said, this death doesn’t change the situation here.

Never before seen mutant virus

Media continues to describe the virus as an unexplained combination of swine, bird and human strains, lending to endless conspiracy theories and scares of mutant viruses. The core of beliefs that this strain of influenza could hold unique dangers to humans compared to ordinary seasonal influenzas originated from misinterpretations of CDC reports that the virus is a combination of bird, pig and human viruses, said Dr. Steven Salzberg, Ph.D., professor at the University of Maryland and Director of the Center for Bioinformatics and Computational Biology. The simplistic explanation reaching the public is incorrect. As we know, viruses naturally reshuffle their genetic material as they replicate. Dr. Salzberg explained that the current swine flu virus is actually a combination of two “already-circulating pig strains.”

The reason for the "triple reassortant" story is a bit complex, but (to simplify a bit): the history of one of the two parental swine flu strains indicates that part of that strain originated in birds — well over a decade ago. That strain is sometimes called "avian-like" as a result, but it's not an avian flu strain now. Second, the history of the other strain includes a small piece (one gene) that appears to have originated in humans — over 15 years ago. Again, it's a swine flu virus now, but there's a piece of it that might have come from humans. The event that created today's swine flu — the one we're worried about — is a combination (called a reassortment) between two pig strains, pure and simple.

There is no reason to suspect that this combination of flu viruses is any more deadly than any other recent swine influenza virus has been.

Pandemic around the corner

The most over-the-top rhetoric has come from the World Health Organization director general, Margaret Chan, when she raised the level of alert of an impending pandemic. “It is all of humanity that is under threat during a pandemic,” she said at a news conference in Geneva. “The biggest question right now is this: How severe will the pandemic be? All countries should immediately now activate their pandemic plans.”

The World Health Organization’s own data fails to support the scary proclamations of its director. WHO reports 91 confirmed human cases in the U.S., with one death, and Mexico has 26 confirmed cases, including seven deaths. Scattered cases have also been confirmed abroad, with no deaths. And, no different from earlier this week: “WHO advises no restriction of regular travel or closure of borders.”

The Department of Homeland Security instructed healthcare providers of the procedures they must follow should the government decide quarantines are necessary. Its notice said: “The Department of Justice has established legal federal authorities pertaining to the implementation of a quarantine and enforcement. Under approval from HHS, the Surgeon General has the authority to issue quarantines.” Under federal law, a quarantine order can be enforced by U.S. law enforcement agencies, including Federal Marshals, the FBI, U.S. Customs and Coast Guard Officers and the Bureau of Alcohol, Tobacco, Firearms and Explosives. Anyone violating a quarantine order can be punished by a $250,000 fine and one year prison term. As CBS News reports, a Defense Department planning document summarizing the military's contingency plan says the Pentagon is prepared to assist in “quarantining groups of people in order to minimize the spread of disease during an influenza pandemic” and aiding in “efforts to restore and maintain order.” Congress enacted the first federal quarantine law in 1796 during the yellow fever epidemic.

The CDC’s own influenza data fails to support any parallels of this swine flu outbreak as being as threatening as a yellow fever epidemic from two centuries ago or Spanish flu from nearly a century ago! The actual number of people sickened by any viral infection is naturally considered to be higher than confirmed cases, but today’s active surveillance by health departments enable reasoned estimates of disease prevalence. The actual numbers aren’t remotely close to tens of millions of deaths. But we don’t hear much about just how few cases there have really been — facts that offer a sense of perspective and balance.

While increasing number of cases of swine flu are being confirmed as testing increases, the number of cases and deaths continue to pale to those seen even with the typical seasonal influenza. As we’ve seen, government health statistics report 30,000 to 50,000 deaths each year in the U.S. attributed to typical seasonal influenzas, and the number of cases is considerably higher. Every week, the CDC reports the number of confirmed cases and this month, in just one week (April 12-18, 2009), for example, the CDC confirmed 25,925 cases of influenza in the United States and 55 child deaths.

Imagine what the media could do with those numbers to scare us. At the same rate of news coverage, that would be more than 25 million stories every week about the deadliness of the flu.

Mexico harboring a deadly form of the virus

Speculations abound as to why there have been more deaths in Mexico than here or any other developed country in the world. Scares are circulating that viruses from south of our border are somehow more deadly and dangerous and that we must keep “those people out.” As we’ve examined, the general health of people in poverty stricken countries such as Mexico is poorer, as is most people’s access to the quality and advanced medical care that we currently enjoy in our country — medical care that makes the difference for surviving the complications of viral infections. There’s a reason our healthcare is seen as the best in the world and our neighbors from Mexico come here for care.

But the “swine flu virus” (influenza A/H1N1) in Mexico is no different than here. Dr. Salzberg and colleagues and several other research groups around the country gained access to GISAID, where the genetic sequencing of flu viruses have been deposited. They found that the genetic sequencing of the virus from Mexico is virtually identical to those from the United States. “It would appear that any differences in virulence are due to differences in the people being infected, not to the virus itself,” he wrote. People living in situations of poverty are at higher risk of dying from all sorts of things that those in more developed countries no longer fear.

Health scams abound

The Better Business Bureau is already warning consumers about scams capitalizing on swine flu fears. McAfee, a computer monitoring company, has been tracking swine flu scams and reports there’s been a huge jump of sites selling supposed swine flu treatments and products, offering everything from face masks to phony vaccines, many websites masquerading as offering medical information. Face masks sales are booming, even though the CDC is not recommending that people wear masks because of limited evidence that they effectively prevent the spread of the disease. As Peter Palese, a microbiologist and infectious-diseases expert at Mount Sinai Medical Center, told the Washington Post, face masks don’t do much good:

Face masks do one thing — they protect people in terms of preventing other people from getting close to them. So you get a sphere of privacy from wearing a mask, but it's largely psychological. The masks do help if someone sneezes right at you. However, the pore size of these masks lets viruses go through. Again it is not a clear-cut yes or no; there is some benefit, but there is not as much benefit as we would like.

Yet, nearly every news story about swine flu is accompanied by scary images of people wearing masks.

What’s really playing on our fears?

Frank Furedi, sociology professor at the University of Kent and author of Culture of Fear, explained that what we are seeing is a moral drama. His thought-provoking article in Spiked-online began:

Recent events show that, while society has the scientific know-how to cope with outbreaks of flu, it still sees disease as a harbinger of apocalypse. The explosion of global fear about the outbreak of a deathly flu virus in Mexico is more a response to the dramatisation of influenza than to the actual threat it poses. There is nothing unusual about the outbreak of flu. Every year, thousands of people die from the flu, and, in normal conditions, society has learned to cope with the flu threat. From time to time, an outbreak of flu turns into a global pandemic, leading to a catastrophic loss of life. However, there is no evidence that the so-called swine flu, which has so far claimed a relatively small number of lives, will turn into a pandemic. Rather, what we are faced with is a health crisis that has been transformed into a moral drama.

As he explains, actual health risks are being inflated today far beyond any real danger. The World Health Organization’s escalation of the pandemic threat of swine flu, he said, “is acting on a script that was cobbled together in the early years of the twenty-first century.”

Since the turn of the new millennium, the term ‘pandemic’ has become normalised and is increasingly used to frame global anxieties and fears. ‘Health alerts’ have been transformed into rituals, through which fear entrepreneurs remind us, in a quasi-religious fashion, that human extinction is a very real possibility. Terms like ‘epidemic’ and ‘pandemic’ appear with increasing frequency in newspapers, and are now used in everyday conversation, too. This tendency to inflate the dangers that we face leads to a situation where fearmongers now speculate about hundreds of thousands, millions or even billions of casualties occurring as a result of some crisis or disaster. Even highly prestigious journals and media outlets seem incapable of resisting the temptation to spread alarmist high-casualty scenarios.

Increasingly, public health officials sound as if they are rehearsing their roles for a disaster movie. They frequently argue that, since we had deathly flu pandemics in the past, it is inevitable that we will face another one very soon…The fatalistic view of an inevitable global flu catastrophe is made more ominous still by linking it with our anxieties about terrorism. Leading British scientist Hugh Pennington also made this link, when he stated in 2005 that avian flu ‘is the biggest threat to the human race’ and it ‘far outweighs bioterrorism; this is natural terrorism’. Inevitably, the dramatisation of the flu has spawned various apocalyptic stories about how viruses can be ‘weaponised’ and used to threaten human survival… In line with Hollywood fantasy plotlines, the report invited us to imagine the possibility of a terrorist purchasing ‘genes for use in the engineering of an existing and dangerous pathogen into a more virulent strain’. Alongside fears about the ‘weaponisation’ of viruses, the internet is awash with rumours about the conspiracy responsible for the current outbreak of swine flu…

As he concluded: “It seems the swine flu outbreak has infected our imaginations, giving shape and tangibility to our anxieties about everyday life. We should give the pigs a rest, and get on with living.”

Not everyone’s imaginations are running overtime, though. The internet has also been the source of some comical perspectives, none better than xkcd.com:

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

Flu Fears

The media loves a good scare and the word pandemic is a guaranteed headline grabber. By this evening, there were nearly 70,000 news stories about an influenza pandemic, many accentuated by pictures of crowds of people wearing blue surgical masks. But scaring you half to death with speculations of a new pandemic does little to help you. The known facts, offered in a balanced perspective, is really news you can use.

As is the case with virtually everything scary in the media, reputable scientists and health experts provide reassuring facts and information. The world is not coming to an end and there is surprisingly little cause for panic.

Words for shock value

Why have the words epidemic or pandemic been used in nearly every headline? The numbers of people who’ve tested positive for the flu are actually so low, these cases don’t come close to meeting either definition.

But the words strike fear into the hearts of people. Most consumers think pandemic means something like the Spanish flu pandemic of 1918-1919, which is said to have killed between 20 million to 100 million people. Something like that is unlikely to happen today, however. Nearly a century ago, the standards of living and medical care, for humans and animals, were vastly different. The country was recovering from World War I, with widespread poverty, hunger and unsanitary living conditions, coupled with no available antibiotics or flu medications or modern medical care.

In fact, most of us have lived through a flu pandemic and never even realized it. The Hong Kong flu pandemic in 1968-69, for example, killed an estimated 33,800 Americans. That sounds like a lot, but it’s about the same number of Americans who die from the flu in a typical year.

Swine flu has even been around us for years. It’s not new. Did you know that influenza as a disease of pigs was first recognized during that Spanish flu pandemic of 1918-1919? Swine flu was first isolated in laboratory tests from a human in 1974. Sporadic cases of swine influenza viral infections in humans have been reported in the United States, Canada, Europe and Asia for decades. “There are no unique clinical features that distinguish swine influenza in humans from typical influenza,” said Dr. Kendall P. Myers at the Center for Emerging Infectious Diseases at the University of Iowa, Iowa City, and colleagues.

Every few years, we are surrounded by dire warnings of an impending pandemic — such as the SARS, avian flu, and 1976 swine flu scares — pandemics that never materialized. As JFS covered during the avian flu scare (when we were being told that 81 million of us could die), these scary pandemic projections are based on computer models that assume the worse case scenarios: a world without medical care or medications, without veterinary medicine, and such social demise and unsanitary living conditions that people will die at the same rates they did a century ago during the Spanish flu pandemic. Most of all, they ignore the science.

Let’s look at some of that science. Because this story is evolving, the specifics will evolve, too, but the main point won’t. For a good scare, filled with sensationalized, exaggerated dangers, turn to mainstream media. For facts, go to the source.

The scientific information given to the media during the U.S. Centers for Disease Control and Prevention’s public briefings bears little resemblance to the versions that have made most of our nightly news and newspapers.

Seek and ye shall find

A point repeatedly emphasized to the media yesterday by Dr. Anne Schuchat, Director for the National Center for Immunization and Respiratory Diseases, was that they couldn’t credibly say the cases being identified in the laboratory are indicative of a new situation. Cases identified with increased surveillance is not the same thing as actual increased incidents.

As she said, we might never have even known about this a few years ago because health departments weren’t testing for unusual strains of influenza viruses. They only recently stepped up laboratory capabilities and in 2007 launched a new reporting system that now makes it mandatory for state health departments to report the detection of untypable influenza strains during their routine influenza season surveillance. “Ten years ago we were not doing that, so we may be seeing something and actively investigating something that has happened many times before,” said Dr. Schuchat. So, we really cannot say that this is anything new.

All of the cases have been detected through routine surveillance for seasonal flu after state labs found strains they couldn’t type and sent the samples to them. “We are doing more testing now and looking more aggressively for unusual influenz