Junkfood Science: January 2009

January 30, 2009

Mercury in HFCS retake

What a week. The heightening panic-stricken rhetoric and scary claims in the media have become so-over-the-top, they’ve been truly frightening people, especially young women afraid for their children. That shouldn't be.

It is so important for people to get this and to understand enough basic science and chemistry to protect themselves from living in constant fear of everything! Next week, it will be something else said to be detected in our foods or bodies that will be used to try and scare us. So, it’s worth taking a moment to clarify some of the most common myths that have proliferated on the internet about this week’s scare: mercury in HFCS.

Be afraid, very afraid

A multitude of interests, it seems, appear to be ready to capitalize on another food scare. Some lawyers, who must see potentially lucrative class action lawsuits in the wings, have come out with some of the most irresponsible and factually inaccurate scares. A publication for San Francisco product liability attorneys, for example, even headlined with exclamation points: “Consumer alert: Mercury present in high fructose corn syrup!” and proceeded to call mercury a “brain toxin” and that it had been found in “high levels” in popular foods and claimed that the FDA had been unresponsive to concerns about “dangerous mercury levels found in high fructose corn syrup.” To add fear of the unknown, it claimed “the source of mercury remains a mystery to researchers and industry experts.” Because of the purportedly high amounts found, they said “it is important [consumers] are aware of the presence of mercury” and went on to claim that no level of mercury exposure is safe, especially for unborn babies and children.

Other bloggers have called mercury a poison and “witch's chemist's brew of industrial solvents and genetically engineered enzymes.” Conspiracy theories have been rampant, with claims that mercury is put into foods by evil food companies and the FDA has been part of “another potential cover-up.”

There is no conspiracy, no mystery, no high levels

Mercury (Hg) is a naturally-occurring element on the earth, and is found naturally in everything that lives and grows on the planet: air, water, soil, foods and us. As the World Health Organization’s latest guidance report produced in Geneva, Switzerland last summer by its Department of Food Safety, Zoonoses and Foodborne Diseases and the esperts at the UN’s Inter-Organisation Programme for the Sound Management of Chemicals, explained: “All humans are exposed to some low levels of mercury… as a result of normal daily activities.”

Virtually everyone, if tested, would find trace amounts in their own tissues, the chemists reiterated, but these low exposures are not anything to be afraid of and don’t cause health risks. We are not all mercury toxic! Detectible levels in parts per million or parts per billion do not equal risk. It is also not at all surprising to find mercury in foods and food ingredients. It’s always been there. Mercury exposure isn’t a mystery or a surprise to scientists.

Natural processes, such as forest fires and volcanoes, release the greatest amounts of mercury into the earth’s atmosphere, as it is a natural product of combustion. Mother Nature gives us the most mercury in our environment, up to 6,000 tons every year. Human activities produce a small fraction of that, with emission dropping for decades in developed countries. Perhaps that’s why 550-year old Alaskan mummies were found to have mercury levels in their hair many times higher than American people today, as ancient peoples lived in cramped, poorly ventilated places warmed by wood-burning fires.

Elemental mercury is used around the world in many artisanal processes and to make lots of products because of its unique properties, explained the WHO chemical experts. “For example, it is the only metal that exists in liquid form at room temperature,” they said. But in this form, as was explained by the Agency for Toxic Substances and Disease Registry, virtually none is absorbed from the gastrointestinal tract or through the skin.

It is false that “mercury is toxic in all its forms” or that any exposure at all is dangerous. Among the scares this week has been a lack of understanding that there are different forms of mercury and each has different effects on the human body. Whether something is harmless or potentially harmful depends on the type of mercury, the dose, the route of exposure (inhaled, eaten or skin contact) and the duration of exposure, as the WHO report explains.

As we reviewed when Jeremy Piven was said to have mercury poisoning from eating sushi, the only cases in the scientific literature of people being poisoned by mercury from eating fish or any food were from fish tainted after an industrial chemical accident in Minamata Bay, Japan in the 1950s, which resulted in fish with methylmercury levels 40 to 1,000 times higher than the fish Americans eat, and that most people around the world eat. And methylmercury is the organic form of mercury and absorbed at least ten times more than the inorganic forms, as in elemental mercury.

Read that again: except for industrial chemical accidents, so rare they make world history, there are no known cases of people (even unborn babies, children or pregnant women) being harmed from mercury or methylmercury in their food. This was covered here.

It is also false that any exposure at all is dangerous or that it is even possible to live on the planet and live in a mercury-free environment.

There will always be people who will try to take advantage of others by trying to make them believe that just because some scary-sounding substance has been found in detectible amounts, that it means danger. It’s so important for consumers to understand that the dose makes the medicine or the poison, with everything. Everything is toxic at high enough doses, but detected does not equal harm. It’s also helpful to understand how safety margins are arrived at for any chemical or substance. When we hear a scary claim purporting to have found “high” levels above “safe limits” in a food or our bodies, that does not mean danger. This was covered in Hair-raising fears.

The biggest give-away that this week’s mercury in HFCS story was nothing but a scare story was that it tried to use mercury to frighten us about an ingredient (and foods made from it) that some want us to believe are bad and supposedly making everyone fat and diseased. This was an egregious example of using fear to advance political ideologies about food production and sales — not good science, nutrition or medical information.

Consumers were not given the full story and weren’t able to make informed choices.

Why was HFCS chosen? Notice how there was no attempt to put the levels of mercury found in HFCS and HFCS-containing foods into context? They could have chosen countless other foods to report mercury levels on — but that information would have made it instantly apparent to consumers that they were being conned.

Lets look at one example. Scientists with Health Canada and its Bureau of Chemical Safety, Food Research Division in Ottawa evaluated the total mercury in foods eaten by Canadians. In order to make scientifically-based risk assessments, they wrote, it is important to have sound facts and they used the most reliable techniques to estimate the total mercury in people’s diets. They measured 259 different total diet food composites, foods as purchased and eaten by consumers, using the most advanced methods, and duplicating each sample’s analysis. To determine the potential daily total amount of mercury people consumed, they conducted in-depth 24-hour diet consumption surveys. They found that the total amount of mercury among Canadians of all ages and genders were well below safety guidelines [Joint FAO/WHO Expert Committee on Food Additives Provisional Tolerable Weekly Intakes, and Canadian guidelines] for both mercury and methylmercury.

The greatest fears in the media this week came from a report by the environmental group, Institute for Agriculture and Trade Policy, which tested 55 commercial foods containing HFCS and reported detecting mercury in 17 samples, at levels ranging from 0.02 parts per billion to 0.1 ppb. The average amounts of mercury found in a wide range of other foods by Health Canada can help us put these numbers into context.

The mercury detected in foods eaten in Ottawa (all numbers are also in ppb):

eggs 1.50

lamb 2.30

cottage cheese 0.97

cheddar cheese 1.02

beef steak 1.80

chicken and turkey 1.80

bran cereal 1.40

donuts <0.14

wholewheat bread 0.18

rice 1.80

beans 0.22

broccoli 0.67

carrots 0.47

celery 0.50

mushrooms 5.10

tomatoes 0.28

cherries 0.26

plums 0.30

milk 0.25

fish 24-69

corn 0.21

raisins 0.68

honey 0.16

beer <0.05

baby cereal 0.35

pizza 0.15

We could go on, but you get the idea. That's why, attempts to scare you over detecting mercury in HFCS made no biological sense. Mercury is in everything — and in nearly every food in greater amounts than reported in HFCS-foods — but the dose makes the poison. None of these foods are dangerous to eat as part of our diets, either. [Note: Be careful with some attempts to make numbers appear bigger by reporting in parts per trillion. That's the equivalent of one second in about 32 years.] As I had concluded earlier this week: Beliefs that we can only be safe by removing from our diets every trace of any substance that has ever been shown to be toxic, means not eating or drinking anything at all.

Science is your friend and understanding science may be the best thing you can do for your health and well being. Hopefully, this will help you arm yourself from being scared by every spooky-sounding thing “detected” in your food.

© 2009 Sandy Szwarc

Edited for calculations 2/5/09.

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January 29, 2009

Who decides what you can eat? Sating on salt

Most consumers trust that public health policies are guided by the best science and are enacted after medical experts have carefully weighed the health benefits for the public against the potential risks for harm. The fact that this does not happen was demonstrated this week with the launch of a major nationwide campaign that could put millions of people at risk. But this story received barely a blip of news coverage.

This new program is being led by the commissioner of New York City’s Department of Health and Mental Hygiene. — Yes, the same department that is requiring hospitals to give itself full access to your medical records and has also mandated that every lab in the state report to it all blood sugar results without patients’ knowledge (or informed consent or ability for patients to opt out) so that it can identify people for state “disease management.”

Dr. Thomas R. Frieden wants to put the entire population on a low-salt diet and is leading a nationwide low-salt initiative, partnering state, local and federal governments and private stakeholders to cut salt in our foods in half within the next decade. The significance of this initiative may have been lost on media. Perhaps it sounded harmless and intuitively helpful because “everyone knows salt is bad.”

It deserves to be out in the open, though, because the best science for nearly half a century — including the government’s own findings on examinations reflecting 99 million Americans; more than 17,000 studies published since 1966; and even a recent Cochrane systematic review of the clinical trial evidence — fails to support the hypotheses that salt reductions offer health benefits for the general public. Cochrane’s reviewers specifically concluded that such interventions are inappropriate for population prevention programs.

It’s not just that the salt reductions being proposed will be costly programs that won’t be of much help to people, but that they could hurt people. Even more troubling, the public health messages in this new campaign appear to be most targeting minorities, fat people, the elderly and poor.

Public health bulletins on the program’s website tell New York consumers that salt is harmful, bad for their health, and that eating too much salt means people are more likely to have high blood pressure, heart attacks and strokes. And “heart diseases is New York City’s biggest killer.” Echoed by the City’s director of cardiovascular health, Dr. Sonia Angell, M.D., MPH, consumers are being told that they’re eating twice the salt they need and that “a low salt diet (1,500mg) can help lower or even control blood pressure.” It even claims that those who don’t have high blood pressure can prevent high blood pressure by eating a low salt diet. “Lower sodium levels by 50 percent, and 150,000 American lives a year might be saved,” said Dr. Frieden.

None of these claims can be scientifically supported.

Missing: a crisis of heart disease. The latest vital statistics data from the CDC National Center for Health Statistics was just released and reported that age-related deaths from heart disease, cancer, diabetes, liver disease and hypertension — all of the causes some want us to believe are due to unhealthy lifestyles, rather than mostly aging — have continued to drop significantly for more than 50 years. The latest Health US report from the CDC found our life expectancy has reached another record high and age-adjusted mortality for the leading causes of death have been cut nearly in half since 1950, including heart disease.

Missing: a crisis of hypertension. The latest National Heart, Lung and Blood Institute study using National Health and Nutrition Examination Survey (NHANES) data found no epidemic of hypertension, either. Actual average blood pressures among American adults changed little between 1988 and 2004. There’s been no statistical change for some two decades in systolic blood pressures among people being treated for hypertension. And average systolic blood pressures among Americans without hypertension has gone from 115 to 117, changes too small to be clinically meaningful. Meanwhile, among all groups, average diastolic blood pressures has decreased during this period (an overall average of 73 to 72).

Missing: a crisis of high salt intake. It may be popular to believe that we’re eating dramatically more salt over recent decades, because of all that processed food and all. The evidence doesn’t support this oft-repeated claim, as was covered in the salt shaker article. Researchers at the Department of Epidemiology and Population Health at Albert Einstein College of Medicine in New York, found Americans aren’t eating anywhere near the amounts of salt being claimed. Their third study in a series examining NHANES data representing 99 million non-institutionalized adults in the United States between 1988 and 1997, showed average sodium intake among Americans has remained about 3,200 mg/day.

Missing: even an association between salt and heart disease or premature death. As covered here, even following the NHANES participants for nine more years through year 2000, the Albert Einstein researchers were unable to show among the general population that those eating the lowest salt diets had lower risks for developing cardiovascular disease or high blood pressure or dying prematurely. In fact, heart disease, high blood pressure and deaths were inversely related to salt intakes: the higher the sodium, the lower the risks; the lower the dietary salt, the higher the risks.

To parse out the effects of dietary sodium intake itself, they factored for confounding influences, including: age, gender, race, education, added table salt, exercise, alcohol use, smoking, history of diabetes, history of cancer, systolic BP, cholesterol, dietary potassium, weight, treatment for hypertension, and calories. [To rule out possibilities that the results could reflect the affects of cancers or illnesses, the authors excluded those Americans who’d died within the first 6 months or those who’d had a previous heart attack, stroke or heart failure.] The associations between low-salt diets and higher rates of cardiovascular disease and all-cause mortality held.

The lowest sodium intakes — the 1500 mg/day that the New York health department says everyone should be eating — were associated with an 80% higher risk of cardiovascular disease compared with those consuming the highest salt diets. The lowest salt intakes were also associated with a 24% higher risk of all-cause mortality. Clearly, low-salt diets are not associated with lower risks for the general population. Conversely, the Albert Einstein researchers were unable to show that even the highest salt intakes were associated with increased risks for developing cardiovascular disease or high blood pressure or for premature death.

A major international research project in thirty-two nations showed that while the incidence of hypertension varied widely, salt intake had little to do with it.

Another major peer-reviewed study published in the European Journal of Epidemiology, examined sodium and potassium intakes and their relationship to cardiovascular disease and mortality. Researchers from Wageningen University in The Netherlands followed a general population sample of people 55 years and older for five and a half years. Clinical exams were done at the beginning of the study, including body measurements, blood pressure, blood tests and 24-hour urine samples to measure sodium and potassium levels. Dietary data was obtained from food-frequency questionnaires.

They found no association between any of the levels of sodium, potassium or sodium/potassium ratios and cardiovascular or all-cause mortality, nor was there a tenable relationship among the overweight study participants. “The absence of a relationship between salt intake and mortality in our study corroborates the findings from the large Scottish Heart Health Study among almost 12,000 middle-aged subjects with 24-h urine samples,” they wrote, adding, “follow-up data of the MRFIT trial neither showed a relationship between dietary sodium intake estimated by 24-h recall and cardiovascular events or mortality.”

Decades of epidemiological evidence simply do not support fears that salt is deadly or that the amounts people naturally eat are associated with harm, or that low-salt diets are associated with improved health or longer life.

Benefits of salt

“By virtue of its central role in maintaining intravascular and extracellular volume, sodium is essential to human survival,” wrote Dr. Michael Alderman, M.D., in the International Journal of Epidemiology. Given free access to salt, humans consume surprisingly similar ranges of salt across a wide variety of diets, cultures, environments and heredities, he said.

In fact, some of the longest-living people in the world also have the highest salt consumptions. Many point to the Japanese, for example — they have one of the highest salt intakes in the world, as well as the highest life expectancy.

Salt not only makes food taste better, it also improves the flavor of foods for those whose tastes or appetites are diminished, helping to prevent nutritional deficiencies especially among vulnerable populations, such as children and elderly. Salt isn’t added to food for malevolent purposes, but because it has had invaluable roles in food preparation and preservation, baking, culturing cheese, and making our food safer to eat since the earliest days of mankind. The healthful benefits of salts, discussed here, also include the importance of the very first functional food: iodized salt.

The European Society of Cardiology guideline experts reported that randomized clinical trial evidence also suggests that “an abundant sodium intake may improve glucose tolerance and insulin resistance, especially in diabetic, salt-sensitive, and or medicated essential hypertensive subjects.”

Other unintended risks of low-salt diet

It’s extremely rare to have too much salt in our bodies, called hypernatremia, (it occurs in about 1% of debilitated hospitalized patients as a symptom of an underlying disease or inability to drink water). But, as covered here, low-salt diets significantly raise people’s risk for hyponatremia, where the amount of sodium in our bodies can become dangerously low. It’s the most common electrolyte disorder and a special risk for infants and elderly, according to Dr. Sandy Craig, M.D., at the Department of Emergency Medicine, University of North Carolina at Chapel Hill. It can result in swelling of our brain, seizures, coma, heat stroke, leg cramps, heart arrhythmias and circulatory collapse. Low-salt diets put elderly especially at added risk for hypodehydration and death.

Growing numbers of clinical studies in the medical literature are suggesting other unexpected negative health effects of low-salt diets, such as activating the rennin-angiotensin system and the sympathetic nervous system and increasing insulin resistance and worsen glucose tolerance, especially for diabetics. These effects could actually raise risks for cardiovascular disease, according to the European Society of Cardiology Guidelines.

Low-salt diets fail to lower blood pressure, heart disease and mortality

Cochrane recently released a systematic review of the clinical trial evidence on reduced dietary salt for the prevention of cardiovascular disease, as well as the effects of low-salt diets on blood pressure and mortality. After 1 to 5 years of follow-up, those who’d received low-salt diets and intensive behavioral interventions, saw their systolic blood pressures reduced by a mere 1.1 mmHg, and diastolic blood pressures by 0.6 mmHg, even while successfully lowering salt intakes as confirmed by urinary 24-hour sodium excretions by 35.5 mmol. As the reviewers wrote: “This reduction was not enough to expect an important health benefit.” Changes in blood pressures were also unrelated to the degree sodium had been reduced — in other words, more wasn’t better. Deaths were also no different between those on low-salt diets and control groups.

The Cochrane reviewers concluded that even “intensive interventions, unsuited to primary care or population prevention programmes, provide only minimal reductions in blood pressure during long-term trials.”

In fact, while there have been more than 17,000 studies published on salt and blood pressure since 1966, even following populations for decades, none has shown notable health benefits for the general population with low-sodium diets. According to Dr. David Klurfeld, Ph.D., professor and chairman of the Department of Nutrition and Food Science at Wayne State University, editor-in-chief of the Journal of the American College of Nutrition, “the better controlled studies fail to show a significant benefit on blood pressure for large groups with sodium restriction.”

The source of claims that reducing sodium intake by half would save 150,000 lives a year, used to petition the FDA to revoke salt as generally recognized as safe, was a CSPI paper. As reviewed here, the claims were not supported by the research, nor even the study researchers’ own conclusions. Similarly, media claims that salt kills or that cutting down on salt adds 12 years to your life also proved unsupported.

The Albert Einstein College of Medicine authors were especially cautious about establishing population guidelines based on currently available evidence. Guidelines calling for reductions are based on the modest blood pressure changes associated with low-sodium diets in short term clinical trials, they said. “However, these trials could not assess the long-term cardiovascular morbidity and mortality consequences.” They added:

[B]asing a lower sodium recommendation primarily on intermediate effects such as blood pressure reduction is also unsatisfactory. Unintended health consequences can result from seemingly reasonable expectations.... In the case of sodium, extrapolations from positive effects on blood pressure may be offset by extrapolations from potentially adverse effects on the sympathetic nervous system, the renin-angiotensin system, insulin resistance, and the potential that other important nutrients might be decreased when free-living individuals alter diets to decrease sodium...

The data here cannot sustain a conclusion that lower sodium is harmful. However, these findings, along with the inconsistent results of other epidemiologic studies, and the propensity for substantial variability among individuals, do not lend support to any universal prescription for salt intake.

In sum, the inverse associations of sodium to CVD mortality observed in this large, nationally representative sample, raise questions regarding the likelihood that a survival advantage will necessarily result from a universal recommendation for a lower dietary sodium intake.

Even the New York Times reported that Dr. Friedman might encounter resistance to his low-salt campaign “on scientific grounds.” Different people have different responses to sodium, dictated by genetics, with some people sensitive to high levels and for others low salt levels can be unhealthy, it concurred.

Dr. Michael Alderman found this campaign alarming. “Advocates of universal restriction of sodium intake,” he wrote, “base their case on the belief that this will produce a population-wide reduction of blood pressure which, in turn, will reduce cardiovascular morbidity and mortality. Indeed, these dogma are often preached with a fervour usually associated with religious zealotry.” He argued, however, “that the available data provides insufficient evidence to justify any universal target for sodium intake for either the whole population or for its hypertensive subset.”

What’s up?

As the New York City-led nationwide low-salt initiative is clearly not founded on a true health crisis, on the medical evidence, or on proven health interventions for the primary prevention of high blood pressure or heart disease, what might it really be about?

As the New York Times pointed out today, the target is going after packaged foods and chain restaurant meals. Reducing salt to levels unpalatable to their consumers appears to primarily be about getting people to eat less of foods these public officials don’t think people should eat or others should sell.

His plan is based on the UK’s traffic light program, reports the newspaper, earmarking such “prime suspects” as cheese, breakfast cereals, bread, pastas, cake mixes, condiments and soup. “Dr. Frieden says a quiet, mass reduction in sodium levels — stealth health, they like to call it around the department — might be more effective,” wrote the New York Times, than relying on people to comply with the government’s dietary recommendations.

Professor Lawrence O. Gostin, director of the Center for Law and the Public's Health at Georgetown and Johns Hopkins Universities, may have called it when he commented:

You can imagine it getting to the point where you have a public health worker showing up at your door and asking, ‘Did you remember to exercise, eat right and take your medication today?’

That appears to already be in the planning.

© 2009 Sandy Szwarc

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Efforts to preserve health care in the Southwest continue

New Mexico is following in Arizona’s footsteps. NM Senator William E. Sharer has introduced Senate bill SJR 1, patterned after Arizona’s “Freedom of Choice in Health Care Act” (Proposition 101), that would ensure the freedom of New Mexico residents to purchase private health insurance and to pay directly for lawful medical care. It would make it unconstitutional to penalize or fine someone for choosing to get or decline healthcare coverage or to participate in a particular healthcare system or plan.

As StateHouseCall.org reports, this legislation was proposed as the ultimate check against socialized medicine in a state where residents have no such protections and a Governor intent on enacting a State-run universal managed health care. As Paul Gessing noted, Governor Bill Richardson’s first managed healthcare proposal for the State failed last year. The Governor had promoted it, claiming that about 23% of New Mexicans didn’t have medical insurance — a figure that became disputed when it was revealed that the Southwest has a significant American Indian population serviced by the Indian Health Service, which isn’t counted as “insurance” in keeping with definitions used in health insurance studies.

The Governor’s series of ten separate healthcare bills introduced for the 2009 session creep New Mexico ever closer to State oversight of health care. His new proposals would require agencies that provide insurance for all public employees and retirees to be coordinated to save costs. His reform package focuses on mandated use of electronic medical records, based on the belief they will reduce medical errors and save costs.

It is now in New Mexico legislator’s hands to give the nation the gift of a good example, as George Will described. It would not only protect State residents “against abridgements of their liberties by their State government but also perhaps against comparable actions by the federal government.,” he wrote. “Clint Bolick, director of the Goldwater Institute's Center for Constitutional Litigation, believes that if Washington were to enact a national health insurance program of prescriptive regulations, Proposition 101 would trigger an epochal constitutional clash ‘between state sovereignty and national power.’”

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January 27, 2009

The latest Scare du Jour: mercury in HFCS

Our bodies are designed and have adapted to thrive on the planet earth. As such, our bodies naturally detoxify and can deal with elements, minerals, chemicals and even bugs, found naturally in our foods and environment. We’re made of tough stuff and not nearly as wimpy and vulnerable as some want us to fear. That resilience is a good thing for the survival of the human species!

There will always be people who try to scare us about some food (it’s always something they don’t think we should eat) by telling us a small amount of some “toxin” — or “neurotoxin” (that sounds even scarier) — has been detected. This is our heads up that we are being manipulated and someone’s trying to take advantage of the fact a lot of people think a chemical or toxin means danger.

With the refinement of modern scientific instrumentation, it is now possible to detect the tiniest traces of things in our bodies and foods — down to parts per billion. That means, there are even more things to try and scare us with. But just because something can be detected does not make it dangerous. Everything is toxic in high enough doses — including water, salt, iron or polonium — but perfectly safe at the levels we typically encounter them. The core principle of pharmacology and toxicology is “the dose makes the poison.”

The scare in the news this week combines two currently trendy evils: mercury and high fructose corn syrup (HFCS) — but attempts to worry us about the findings of a new study make no biological or scientific sense. Since the mainstream media isn’t reporting the science and is only giving the press release version, at reader request, let’s take a quick look at the facts.

The new study in the news was published in Environmental Health, an online open-access publication of BioMed that allows any member to publish an article for a fee. It was led by Renee Dufault, MAT [masters of art in teaching], at United Tribes Technical College in Bismarck, ND. Briefly, 20 samples of HFCS gathered in February 2005 were tested for mercury at the University of Wisconsin-Platteville. The average levels of mercury in the samples were 0.113 parts per million (μg/gram). In eleven of the samples, the levels were below the level of detection even using the most sophisticated equipment.

This led them to call for FDA testing of all foods containing HFCS for mercury and labeling to inform the public of “any detections.” The reason they gave is because “mercury in any form… is an extremely potent neurological toxin.” No exposure is the only safe exposure, they said.

Understanding science is the only way to protect ourselves from being continuously and needlessly scared. There were at least three inaccuracies in this story. Did you catch them?

Exaggerated consumption. To heighten concerns, the authors claimed that it “may be necessary to account for this source of mercury in the diet of children and sensitive populations” because the average daily consumption of HFCS is about 50 grams per person in the United States.

This claim, however, incorrectly used industry supply and production data from the Market and Trade Economics Division at the USDA’s Economic Resource Service to extrapolate actual dietary consumption among Americans. ERS data has been repeatedly been shown to be faulty and to wildly exaggerate what people really eat. For example, as we know, it doesn’t account for exports and only estimates waste. National Health and Nutrition Examination Surveys (NHANES) conducted by the U.S. Centers for Disease Control and Prevention, based on nationally representative dietary assessments, has been recognized among medical professionals as the most reliable data available on the foods eaten by Americans. Even still, the ERS data shows that market levels for HFCS in 2007 were unchanged from the early 1990s, with no statistical changes in total sweeteners during that time. In other words, we’ve been consuming this amount of sweets for decades. It turned out to be irrelevant, except the use of ERS data was our clue that something other than clinical understanding of nutrition was going on.

Failing to understand that all forms of mercury are not the same. Mercury is one of those ubiquitous elements on our planet and humans have always been exposed to low levels. It is everywhere, naturally. So, medical scientists know and, as expected, have always found mercury in food and in everyone’s bodies — bodies of normal, healthy people.

But an important fact the media has left out of this story is that elemental mercury is not a health threat when ingested (or handled) because virtually none (less than 0.1%) is absorbed through the digestive tract (or skin).

“The body does not readily absorb liquid mercury through the skin or stomach,” according to the Agency for Toxic Substances and Disease Registry. A fact confirmed by every scientific agency. “Virtually no elemental mercury is absorbed from the gastrointestinal tract or by the skin,” said the ATSDR.

So, the 0.113 ppm of mercury purportedly in HFCS makes even less sense to panic over. Even more, it’s biologically implausible for 0.000113 part per million that might be digested to be dangerous. We’d have to eat impossible quantities to get enough to worry about.

Only when breathed in and absorbed through the lungs, high levels of mercury vapor can be harmful. However, vaporization occurs very slowly over time, and the Association for Science Education in the UK reports that negligible amounts of mercury are released from small beads of mercury from old thermometers even after 7 months. That’s why all of us who played with little beads of mercury as kids didn’t drop dead or lose our marbles.

The infinitesimal amounts of mercury detected in the samples in this study are so far below any level that has ever been even remotely associated with the slightest effect on humans — even if it was absorbed in our gut — that the panic reaction and massive and costly interventions being proposed to test and label every food, or to create a mercury-free environment, in order to be safe are especially illogical.

The president of the Corn Refiners Association also told Reuters this morning that their industry hasn’t used mercury reagents mentioned in the study for years, leading her to question the information.

Bottom line evidence. Notice how this study only reported having detected mercury in HFCS, but didn’t measure the mercury level in a single person or child — they left it to our imaginations to assume that detectable levels in our foods meant dangerous levels in our bodies. There is no credible support to fear that the mere presence of mercury — in a fraction of a part per million — in HFCS, and other foods we regular eat, is dangerous.

The final reassuring proof comes from CDC tests of the actual amounts of mercury in our bodies. Since 1999, NHANES has studied mercury levels in our bodies and found that even in the most vulnerable groups of Americans, women and children, we don’t have values anywhere near actual unsafe levels.

The level used for safety regulations has an enormous built-in safety margin. To arrive at this level, they took the level where there was no observed effect at all in the most sensitive of the population with a lifetime of exposure — a level nearly ten times that found in most American women — and added another ten-fold safety cushion to that. This safety cushion is not a threshold where there is any possible actual risk to health — even though it’s used by those trying to scare us to define “high.”

Beliefs that we can only be safe by removing every trace of any substance that has ever been shown to be toxic [at high doses] from our foods, means not eating or drinking anything at all.

Science gives us better sense than that.

Part Two is here.

© 2009 Sandy Szwarc

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A bariatric patient wants other women to know…

A young nursing assistant had sought help for a back injury five years ago, and her doctor recommended bariatric surgery. She lost 120-pounds, but it has not been a happy ending. Looking shockingly decades older than her real age, malnutrition has cost her her health, her job, and most of her hair and teeth. She and other women around Modesto believe that more attention deserves to be given to the long-term complications of bariatric surgeries and bravely shared their stories with the Modesto Bee this weekend.

These are the truer pictures of the pain and complications of bariatric surgeries that those of us who’ve cared for these women see far more often than those glowing before-and-after stories in the media.

These women showed tremendous courage in opening their hearts and going public, hoping to help other women. Their stories deserve to be heard. Please be sure to watch Sandi’s touching video interview [halfway down the page]. As reporter Ken Carlson wrote:

Weight loss surgery's complications devastate some patients

Sandi Krueger of Turlock dropped 120 pounds with weight-loss surgery, but she is hardly a success story. The 2002 surgery led to chronic malnutrition and anemia. As the pounds melted away, so did her life. With a sunken face and protruding collar bones, she is too weak to work and spends most afternoons on the couch wrapped in a blanket. She has thoughts of giving up, but wants to be there for 12-year-old daughter Megan and 19-year-old son Dustin. "It's not acceptable leaving me like this," said the 103-pound Krueger, who at 38 looks closer to 50...

Krueger's options appear to be running out… "This isn't a life," said Robert De Kasha, her brother. "If she doesn't find an answer, she is just going to fade away."..

She had what's called a Roux-en-Y gastric bypass …[and] lost weight quickly as dumping syndrome made her sick for months. When she went to the doctor with complaints, he urged her to stick with the dietary instructions and take supplements, she said….

After a second surgery attempting to correct the complications, she gained 22 pounds, only to plummet down to 98 pounds and be hospitalized for severely low blood sugar.

Tests have shown that her pouch no longer holds food but dumps it directly into the small intestine. Even if she eats five times a day, she doesn't get the protein and other nutrients she needs… Krueger said it's heartbreaking for her daughter to see her tired and faint all the time. She has lost hair, her teeth are decaying and she's often out of breath. To treat her anemia, she's had a blood transfusion and three rounds of iron infusions. A reaction to the last infusion caused her blood pressure to plummet and nurses to come to her aid. Last year, she was considered for having the gastric bypass reversed at UCSF, but doctors told her in December that it was too dangerous. They were concerned that her remaining stomach would have inadequate blood flow and would rot, she said…

If they would put me on the operating table to take me back to 250 pounds, I would do it."

Two other Modesto-area women came forward to describe their situations. Donna also suffered from dumping, malnutrition and dehydration, as Carlson wrote:

Attempts to eat made her feel sick and sweat profusely, even though she followed the guidelines to eat pureed food and take small bites, she said. She went from 246 pounds to 123 in six months and landed in the emergency room, where she was treated for dehydration for several hours, she said… Five years after the surgery, she still is forcing herself to eat... She said one of her daughters had the same post- surgery troubles, as well as a calcium deficiency resulting in dental problems.

Another young mother told the paper that she’s had two hernia surgeries since her bariatric procedure and suffers from severe iron deficiencies and has had to have a port inserted into her chest for iron infusions. She faces yet another hernia surgery and has lost her hair. “I still get dumping syndrome,” she said. “If I don't chew my food 50 times, it collects at the bottom on my esophagus and I throw up.”

The strength of this newspaper article was in the reporting from original sources: the women telling their own stories. When the reporter moved away from original sources and attempted to balance this story by reporting the research, he didn’t go to the original studies himself. He went to bariatric surgeons and the information became confusing and contradictory, and the women’s situations were downplayed. In fact, it was falsely implied that they were to blame and complications could be avoided if patients are simply “responsible for complying with the recommendations for follow-up, nutrition, exercise and behavior change.”

The reporter cited unnamed studies and unnamed sources purportedly finding patients with long-term complications are the minority and such outcomes are rare. “[Bariatric surgery] has improved the lives of people who suffered from diabetes, high blood pressure, sleep apnea and other issues, experts say.”

Readers didn’t learn that these promotional claims have not been soundly supported in the medical literature. The Mayo Clinic also reported that 20-25% of gastric bypass patients develop life-threatening post-op complications and even the recent Lap-Band U.S. clinical trials done to earn FDA approval had reported 89% of patients had at least one adverse event, one-third of them severe. A recent study by researchers at Virginia Commonwealth University found that 56% of bariatric patients had 62 different gastrointestinal complications and abnormalities. The surgical complications and failures of bariatric surgeries are so significant, according to bariatric surgeons with Tampa General Hospital in Florida, that revisional (second) surgeries are required in up to 23% of gastric bypasses and in 5-36% of vertical banded gastrophy cases. Vomiting after gastric bypass procedures occurs in up to 68.8% of cases and can become chronic, resulting in severe malnutrition, according to Brazilian surgeons in a 2005 study published in Obesity Surgery. The long-term nutritional complications are even more extensive.

In fact, the complication rates are so high and the complications so severe that even Dr. Edward Eaton Mason M.D., Professor Emeritus of General Surgery at University of Iowa Hospital and inventor of gastric bypass, cautioned: “For the vast majority of patients today, there is no operation...without introducing risks and side effects that over a lifetime may raise questions about its use for surgical treatment of obesity.”

Concerning the risks and benefits, the reporter said “a 10-year Swedish study found many patients kept the weight off and had increased longevity.” Neither claim had been credibly demonstrated in that study, as we’ve learned. “The benefits by far outweigh the risks that are associated with the procedure,” another bariatric surgeon was quoted as saying. But the largest and strongest study to date on every bariatric surgery done on Pennsylvania residents during the entire decade from 1995 through 2004, revealed that by best estimates, bariatric surgery likely increased the actual mortality risks for these patients the first four years post-op by 363% to 250%.

When patients bravely come forward to share stories that confirm what the soundest studies show, their voices deserve to be heard. Most patients are experiencing complications, yet we almost never hear those stories in the news.

This article provided a rare attempt to offer that balance.

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January 25, 2009

Please keep your babies safe — new vaccine information for parents

If only it was possible to help every new parent understand and trust doctors on this one.

For those of us healthcare professionals who were practicing as recently as the 1970s and early 1980s, the latest news from the Centers for Disease Control and Prevention (CDC) went right through our hearts. The CDC just reported that a 7-month old infant died, and another four became seriously ill from Haemophilus influenzae type B (Hib) last year in Minnesota (which tracks illnesses more closely than many states).

The baby had not received any of his Hib immunizations, nor had two of the other children. The remaining two had only received two of their primary Hib series and none had had their 1-year booster shot. The CDC report, which was published in the January 23 issue of MMMR—Morbidity and Mortality Weekly Report, also found that fewer than half of the 7-month olds (46.5%) in the state had received their Hib series, a significant drop. That means we could be losing the herd immunity protection — that comes when high numbers are immunized to help protect others whose immune systems make them more vulnerable to getting sick, even when vaccinated, or protect babies too young to have yet received the full immunization series. And, in fact, one of the afflicted children was especially defenseless: a 3-year old who had an immunodeficiency.

With considerable relief, we thought Hib had been pretty much eradicated here, thanks to the Hib vaccine that became available in 1987, and most children were routinely getting the vaccine by the early 1990s. [Click on timeline image to enlarge.] Before then, about one in every 200 babies and children under age five came down with invasive Hib infections and it seemed like we cared for a child terribly sick with meningitis or pneumonia nearly every week.

By around 1994, Hib had become so rare — the CDC has found fewer than ten Hib-related deaths a year since then — that we didn’t have to worry about it much anymore. Neither did parents. And that’s a very good thing because, as Dr. Lance Chilton, M.D., professor of pediatrics at the University of New Mexico and co-chair of the Clinical Prevention Initiative Immunization group, explained, back in the 70s, about one in every 20 of those sick children died, and one in five was left with severe disability. We don't want to go back to those days.

Today, most younger doctors and nurses have never even seen a case of Hib and few parents have watched babies get sick or die from Hib. So, Hib might not seem a big deal. We can only hope that we can reach young parents and help them understand why it is a big deal and why it is important to get their babies vaccinated.

It might have been tempting to disregard these cases in Minnesota as possibly as statistical fluke — except for another troubling finding in the CDC report. The children who hadn’t been vaccinated weren’t because of a vaccine shortage, but because the parents or guardians had refused to have their children vaccinated.

There are so many claims out there trying to scare parents about vaccines. I was going to address some of them, but there isn’t any science to address. They are not grounded in any good science. “Vaccines are among the most tested drugs we have,” said Dr. Chilton. Nothing is risk-free in life, but the risks of not vaccinating our babies are so much greater.

The Hib vaccination series begins at a baby’s 2 month check-up. Please don’t worry that they’re too little for a shot — it hurts a lot less than getting sick with Hib. One mother, and a registered nurse, wrote about how she’d procrastinated getting her daughter immunized until it became too late. Her daughter got sick with Hib, which caused epiglottitis (the airway quickly swells shut), a scary thing you only need to see once to understand the value of vaccines. Sometime, we can’t even get a breathing tube in, but her little girl was lucky.

Another news story this week brought home the devastating reality of Hib. Reporting from the Pediatric Association of Nigeria Conference, Drs. Adegoke Falade and Dr. Kikelomo Osinusi described a tragic situation they have been facing every day in their practices — a reality that doctors and parents here would find unimaginable. While Nigeria is the one of the wealthiest countries on the African continent, it has one of the highest child mortality rates.

One out of every five Nigerian children dies before reaching their fifth birthday.

The disease that is responsible for the most deaths among Nigeria’s youngest children — killing more than 200,000 children a year — is pneumonia. Half of those deaths are due to Hib and pneumococcus. The greatest challenge these doctors face in working to improve child health there is trying to get Hib vaccines to children.

Googling for health information is increasingly becoming a tangled web of junk for parents to try and sort through. It is understandable why it’s hard to know what to trust or how to weigh the risks and benefits. Admittedly, there is also a lot of unsupportable preventive public health stuff out there, but basic childhood immunizations are not among them. Below, are some good sources of information, along with the vaccinations that are recommended by the CDC.

Please protect your babies.


HibDisease.com — information and research for parents, medical professionals and media from the National Association of Pediatric Nurse Practitioners

Information on Hib and other vaccinated diseases at Every Child by Two

CDC Hib Vaccine: What you need to know

CDC recommended immunizations for children

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January 24, 2009

National Patient Registry

The push to create a nationalized electronic medical records system has been stepped up with a massive influx of another $20 billion in government funding and new mandates. Independent studies estimate the real costs to taxpayers will run at least $75 billion to $100 billion over the next ten years, as CNN Money just reported. The goal is to put the health records of all citizens into a government computer network within the next five years. The medical records from every doctor office, clinic, hospital, laboratory, pharmacy and diagnostic facility in the country would be interconnected “to ensure the uninhibited flow of health data” among all stakeholders and federal agencies, according to the Department of Health and Human Services Department.

The accelerated adoption of a national health information technology (IT) has been led by a partnership of stakeholders and government officials. State governments have successfully enacted more than 130 health IT bills in the past 18 months, according to the National Conference of State Legislatures.

What is being envisioned, as we’ve seen*, is distinctly different from traditional health department disease registries. National health IT would put government officials in the position of overseeing the healthcare decisions made by consumers and their care providers, tracking chronic disease management, and monitoring compliance with public health performance measures. We’ve been told, though, that national electronic medical records (EMRs) under the direction of the HHS National Coordinator, will improve “quality” of health care, increase efficiency and cut healthcare costs, and reduce medical errors.

Once our personal heath information is in digital form and in a centralized government network, there will be no turning back, which makes going in with both eyes open so important. We continue our ongoing series* examining the evidence behind these promoted benefits and the various concerns being raised about EMRs, with a look at two documents few in the public have ever seen. Written by stakeholders, these reveal the real costs, risks and feasibility for hospitals and healthcare providers when instituting health IT. Most troubling, were the legal arguments being made to overcome issues of invasions of privacy and the inability of consumers to opt-out or give their consent for their personal health information to be accessed or used.

VA scandal

While the evidence to date has failed to provide credible support for claims that EMRs improve health outcomes for patients, save lives, reduce medical errors, or can yet protect privacy and security, problems were put in the national spotlight last week when the VA story broke.

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. Its universal medical records network is one of the few health systems in the country to go nearly paperless, and it’s been held up as an example of the benefits possible with health IT.

But, as we learned last week, continuing software glitches since August 2008 had not 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, some of which might have been life-threatening. As AP reported:

The VA's recent glitches involved medical data—vital signs, laboratory results and active medications—that sometimes popped up under another patient's name on the computer screen. Records also failed to clearly display a doctor's stop order for a treatment, leading to reported cases of unnecessary doses of intravenous drugs such as blood-thinning heparin.

As the AP uncovered: “VA medical centers reported that automated dispensing machines sometimes printed out the wrong patient name when filling prescriptions for outpatients, according to an internal VA memo dated Nov. 5.”

The chairman of the House Veterans Affairs Committee launched an investigation of the computer glitches last Thursday, calling the problems a sign of a “dangerous lack of accountability.” The problems had been kept quiet and then downplayed as inconsequential and nonthreatening, said Rep. Bob Filner. “VA bureaucrats consistently refuse to provide necessary information regarding the serious problems that affect veterans and this pattern of secrecy is disconcerting and does enormous harm,” he said.

If the VA’s electronic medical records, that are supposed to be the nation’s best example of how well they work, are having these major and ongoing problems surface, many called for caution before rushing forward to fund or mandate them throughout our entire nationwide healthcare system. As we’ve seen, doctors and hospitals are not adopting EMR to a notable degree and are voicing a wide range of problems in the reality of EMRs — from impractical costs of implementation, nonfunctionality in work flows especially in acute care and emergency settings, increasing inefficiencies and inaccuracies in charting, reducing productivity, failure of the performance measures to improve patient outcomes, and safety issues.

Even the Joint Commission, which accredits health care organizations and programs in the United States, has issued several Sentinel Event Alerts about adverse events due to “computerized provider order entry, automated dispensing cabinets, electronic medical records, clinical decision support, bar coding or RFID, virus threats to information security, CT scanning technology, and the loss of patient data.” Its December 11th report said “there is a dearth of data on the incidence of adverse events directly caused by HIT overall,” but the United States Pharmacopeia MEDMARX database includes 176,409 medication error records for 2006, of which about 25% involved computer errors.

Finding healthcare systems reticent to institute EMRs, government agencies are taking increasingly heavy-handed tactics. Last month, New York state began requiring hospitals to invest in EMR systems that are connected to, and are interoperable with, the State Health Information Network to enable the information to be shared, as part of its hospital certification of need process. This certification process is required before a hospital can expand, engage in any new construction or other capital improvements. The new mandate will cost Mount Sinai Hospital more than $34 million for a new EMR system, according to GovHealthIT.com.

Lori Evans, deputy commissioner of the New York State Department of Health in charge of its Office of Health IT Transformation, said the certificate of need process will help to rectify compliance with EMRs.

Before heading the NY health IT initiative, Ms Evans was Senior Advisor at the Office of the National Coordinator for Health Information Technology at the HHS, responsible for EMR adoption. Prior to that she was Vice-President of the eHealth Initiative and Director of the Connecting Communities for Better Health Program. Connecting for Health is a New York-based public-private collaboration of more than 100 stakeholders in health IT. It is operated by the Markle Foundation and supported by the Robert Wood Johnson Foundation. Its steering group, established in 2002, has taken the leadership role in developing the policy and technical frameworks to “clear the way for an interoperable health information infrastructure.”

Inside report: HIE (health information exchange)

This brings us to the first paper to share with you. It was written for health information exchange collaboratives, of stakeholders (RHIOs) working to implement EMRs to enable the sharing of electronic health information. In 2006, Ms Evans, along with co-authors at Manatt Health Solutions (which provides legal and consulting services in health IT) and the American Hospital Association, wrote an Executive Brief, “What Hospitals and Health Systems Need to Know.” It offered business and legal advice, based on the lessons learned from over 150 projects tried across the country.

Costs.The first revelation came in the exorbitant costs involved in the planning, development and implementation, and operating of EMRs. We never hear the full story of just how much healthcare resources must be diverted to implement these systems.

In the planning phase, alone, it revealed, the costs for a hospital “generally range from $300,000 to $1,000,000 and involve intensive educational sessions, meetings, business planning, readiness assessments, vendor selection, and legal and organizational costs.”

During the development and implementation phase, the costs “will depend on the scope of the project, including the technical and business approaches, as well as decisions about how different project costs are shared among the parties.” It explained:

Costs can range from $3 million to $10 million, depending on the technology platform selected, the vendor, and the number and complexity of the interfaces that need to be built, among other considerations. Costs will be considerably higher if they include implementing e-prescribing, EHRs or other information systems in provider settings, and/or population health improvement applications, such as disease management initiatives or public health surveillance and reporting.

Then, to keep the systems operational, it reported: “Generally speaking, operational budgets range between $2 million and $5 million annually.”

What’s in it for hospitals? The extent to which a hospital will benefit from information exchange will depend, the paper reported. “Hospitals show variable health IT adoption, depending on their size.”

[S]mall hospitals, especially those serving the safety net and rural areas, exhibit very low technology adoption rates, and nearly all small providers face economic hurdles to EHR adoption. For these hospitals, participation… is likely to impose significant economic hardship.

While not saving costs for most providers and hospitals, the Manett paper said, however, that hospitals are critical to making EMR work. “If you can’t get hospitals on board, you can’t do it.” But with healthcare providers operating in a competitive marketplace with thin margins, “competitive issues often pose the largest barrier in the early planning stages… and it is not uncommon for early meetings to include a number of cautious skeptics around the table.” Hospitals also have “practical concerns about the forces driving the initiative and how the information could be used.” State and federal funds were said to be necessary in order to build and support EMRs in hospitals.

While this paper said federal expenditures in supporting the institution of health IT have been limited, the amount of taxpayer dollars it described that had been spent just back in 2005 were not trifling. The Agency for Healthcare Research and Quality, for instance, had authorized $139 million in grants to drive the adoption of health IT, it reported. These grants were spread across 38 states to a number of health care stakeholders; five grants of $1 million annually for five years were awarded to states to specifically develop health information exchange networks.

Congress has also focused considerable attention on federal policy and funding for health IT, it said.

Federal agencies are also employing more heavy-handed techniques to compel compliance, as with the latest regulation in New York. The Centers for Medicare and Medicaid Services has a number of initiatives designed to encourage HIE, it reported, “including a pay-for-performance demonstration program for doctors who treat Medicare patients.”

New York state, where Connections for Health is based, has put special emphasis on EMRs and spent considerable amounts of state moneys, the report revealed. The $1 billion capital financing program, New York Health Care Efficiency and Affordability Law for New Yorkers Capital Grant Program, was created by the state in 2004. At the time of this Executive Brief, it revealed:

“The state is currently considering applications for the first phase of the health IT initiative in which it is anticipated that a total of $53 million in grants will be distributed. Grants will likely be between $50,000 and $10 million and will support the development of clinical information exchange projects, the creation of e-prescribing capabilities and the use of EHRs.

As the Executive Brief explained, the NYSDOH had created a high-level, multi-stakeholder committee to develop a plan for the stakeholder group by June 2006. The New York State Department of Health’s health IT implementation program then came under the direction of the paper’s co-author, Ms Evans.

Technology. The Executive Brief then addressed whether the technology was actually ready:

The short answer is that there is no one commercial technology product for RHIOs, and the suite of technology components for HIE is emerging but lacks standardization or commercial maturity. Stakeholders involved in RHIO projects today must be comfortable with being pioneers and navigating new terrain.

Privacy and Security. The most disturbing section was the one answering the question of whether privacy and security could actually be achieved. Instead of answering that, however, its focus was on whether HIPAA (Health Insurance Portability and Accountability Act of 1996) would in any way put up roadblocks to the free exchange of electronic health information among this collaboration of stakeholders. Regular JFS readers will already know the answer:

Fortunately, in most HIE projects, HIPAA creates parameters but not roadblocks. HIPAA permits hospitals to share protected health information for treatment, payment and health care operations (such as quality improvement) without patient authorization Given the fact that most HIE projects are focused on using data for these purposes, they generally can be implemented under HIPAA without establishing a patient authorization process.

State privacy laws, however, pose more formidable challenges. Many states have laws that are more stringent than HIPAA and require patient consent for the disclosure of health care information, particularly for highly sensitive information, such as mental health, HIV/AIDS and genetic testing data…

Collaborations may want to go beyond the letter of the law to build public trust, or for business or risk management purposes.

Which brings us to the second report you have to read to believe — just in case anyone still believes protecting privacy is a concern.

Outmaneuvering the law

In 2005, an important Policy Brief was produced by lawyers at The George Washington University School of Public Health and Health Services, Department of health Policy, funded by the Robert Wood Johnson Foundation. Titled “Charting the Legal Environment of Health Information,” it outlined the legal issues surrounding the gathering, sharing and disclosing of people’s health information, especially with the development of EMRs. While stakeholders read this, few consumers did.

Law has a profound impact on health care, since it offers a means of assuring that major advances in care are implemented in a manner consistent with equally important economic and social goals…. Notwithstanding the reluctance and slowness with which physicians have embraced the use of electronic health information… a major driver of this change has been the federal government itself.

What few consumers know is that HIPAA requires covered health care providers to comply with the electronic exchange of health information for claims payment and eligibility purposes for all federally subsidized health care, as this legal policy brief explained:

HIPAA requires covered entities, including health plans and most health care providers, to comply with electronic data interchange standards as well as transmit health data electronically for claims payment and eligibility purposes. More recently, the Medicare Prescription Drug, Improvement and Modernization Act (commonly known as the Medicare Modernization Act or MMA) authorizes the Centers for Medicare and Medicaid Services (CMS) to develop and administer electronic data systems to facilitate provider quality measurement activities in connection with Medicare program administration. The law also directs the Secretary to condition hospital payment on the electronic reporting of quality indicators and to tie the level of payment to quality measurement (i.e., “pay for performance”).

Under the Rule, covered entities are permitted to use or disclose personal health information (PHI) without specific individual authorization for treatment, payment and health care operations… Although the legal experts with whom we consulted believed that HIPAA poses some challenges to the establishment and use of electronic health data systems, the experts agreed that although the HIPAA issues needed to be addressed and carefully analyzed, rather than ignored, ultimately HIPAA was not likely to be a substantial legal barrier.

This report also explained to policy makers that the key motivations for creating a national electronic medical records system is to enable stakeholders to monitor and compel compliance of healthcare providers to their most profitable performance measures. While they are couched as being clinical “guidelines” for improving “quality” of care, by making them compulsory for accreditation and pay-for-performance measures, in reality they have the force and effect of law. Wavering from these “professional practice standards” could put doctors and hospitals at risk for being personally liable and vulnerable to claims of malpractice.

One of the most significant new drivers of modern health information systems is the incorporation of health information measurement and reporting capabilities into national industry accreditation standards. For instance, the National Committee on Quality Assurance (NCQA), an industry-based quality measurement and accreditation organization, measures the performance of health care organizations, health care institutions, and health professionals against quality metrics. Another example of quality measurement from a large purchaser perspective is the Leapfrog Group for Patient Safety, which has developed guidelines for hospital care and which is now focused on physician care. Even more significantly perhaps from a legal standpoint, the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) has now proposed to make the collection of data on patient race, ethnicity, and primary language spoken a basic aspect of organizational accreditation for managed care organizations and integrated systems, and in both ambulatory and institutional settings.

By themselves, industry accreditation standards do not have the force and effect of law, but standards such as practice guidelines prepared by NCQA, The National Quality Forum, The Leapfrog Group, and other measurement systems, as well as formal accreditation standards themselves, signal the increasing importance of quality benchmarking in practice and the need for effective information to support practice improvements. As government payers, private insurers, and industry-self monitoring enterprises all come to embrace information competency, these expectations become part of the standard of professional performance

Far from making people’s private health information more secure and protected from breaches of privacy, this policy paper acknowledged that EMRs would increase those risks. But it doesn’t take close reading to see that the ability of government officials to gain access to private health information without people’s knowledge or consent could also be viewed as a benefit to the government:

In the “pre-electronic” world of health information, breaches of privacy required overt physical acts of some sort. A health provider might impermissibly divulge information either orally or in writing, carelessly throw out medical records in unsecured trash receptacles, or leave files lying around. If the government wanted to seize private health information, authorities had to make a physical demand for it, thereby placing individuals or information custodians on notice that the information was being sought.

But electronic information increases both the ramifications that can flow from a privacy breach (i.e., the number of persons injured through a single unauthorized disclosure), as well as the potential for government officials (and others) to obtain access to information without individual knowledge or consent (i.e., by culling the data from health data warehouses or central repositories). As the diagrams set forth in Appendix A suggest, the very existence of data warehouses could be perceived as creating unprecedented opportunities for privacy breaches.

A lot of legal loopholes and unaddressed questions exist for which the public has no legal protections in place. Yet, government is moving forward with EMRs before protections to protect consumers’ privacy and rights on how their private health information is used are enacted. The paper listed eight such questions:

1. Whether patients own their own medical records and how their information could be accessed

2. The appropriate use and disclosure of personal health information to third parties (such as “releasing prescription drug practices or psychiatric treatment notes”)

3. The power of government to compel the collection and disclosure of personal health information as part of public health oversight or law enforcement (such as “federal requirements related to the provision of treatment data for purposes of quality measurement”)

4. The power of third-party payers to force the collection and disclosure of information (such as compliance with treatments) as a condition of payment or for purposes of “performance measurement”

5. How data could be accessed as for privately-mounted civil litigation claims based on one or more theories of liability (such as “demands for data as part of legal discovery requests, in order to aid an injured party in fashioning and proving a civil claim of medical negligence, breach of a legal duty, or violation of law”)

6. Questions regarding data access by government law enforcement agencies to support civil or criminal investigations (such as abortions performed)

7. When and how personal health information could be accessed for research, how the data is de-identified, and whether the publication of information is restricted

8. And finally, “the legality of race and ethnicity data collection by the government or private industry for ‘quality’ improvement purposes.”

The most disturbing section of this legal Policy Brief was when it brought out the Constitutional arguments and pointed out that people have no constitutional rights to informational privacy and that by centralizing the data into a national interoperational system, opportunities for breaches of confidentiality increase:

The Constitution itself does not expressly provide for a right to informational privacy. Outside of the Fourth Amendment, the Supreme Court has not articulated a strong standard for a constitutional right to informational privacy. However, the Supreme Court has recognized a limited right to informational privacy as a liberty interest within the Fifth and Fourteenth Amendments in the case of Whalen v. Roe. Specifically, Whalen stands for a narrow right to informational privacy with regard to the disclosure and security of data held in governmental databases – a right that must be protected through adequate safeguards in the governmental system. Yet attempts to interpret the breadth of the constitutional privacy protections articulated in Whalen have been inconsistent at best, leaving us with a right in progress. Thus Whalen has failed to create a powerful constitutional right to medical information privacy.

As a practical matter, how can individual requests for confidentiality regarding certain medical data be honored? This issue is related to the potential interaction of state law protections for patients regarding sensitive medical information, such as diagnoses and treatment for medical conditions, such as mental health, substance abuse, HIV-AIDS, and family planning services. However, breaches of confidentiality become less likely in decentralized system since the requested data is only aggregated for a moment in time to respond to a particular query and then reverts to its original source.

We live in a doublespeak world. Few words and phrases mean what we think they do. Nothing illustrates that better than: "A crisis is said to need immediate government action to modernize our healthcare system and make sure every doctor’s office and hospital in the country is using electronic medical records, because it can cut red tape, prevent medical errors, improve quality of care, and help save billions of dollars each year." Do you see what they are creating? Do you want the government to know everything about you, while it also controls what healthcare you can receive and what care your doctor can provide? Do you see how much control over your body, lifestyle and health decisions the government will have?

If we let evidence rather than rhetoric guide us, then up has become down, bad has become good, wrong has become right… Will enough people know to turn back around?

© 2009 Sandy Szwarc

* Electronic medical records

Health benefits:

Separating myth and evidence about electronic medical records

Security issues:

Electronic medical records — different perspectives sharing the same news pages

The hospital was unaware any medical records had been stolen…

Meaning of “quality of care”:

What doctors are talking about with healthcare reform

Patient lives and medical errors:

Costs don’t just mean financial — EMRs and patient lives

Privacy issues:

Electronic health records — we have ways of making you...

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