Perhaps because of its English origin, the image of a primrose path leapt to mind when I read about the UK's Food Standards Agency this week announcing a second round of "more challenging" sodium targets for British food manufacturers. The theory is that if people eat foods lower in sodium they will lower their overall sodium intake. The theory's beguiling simplicity is easy to embrace rather than the "steep and thorny way" of rigorous science.

William Shakespeare immortalized the expression in Hamlet where Ophelia warns her brother Laertes against succumbing to libertine indulgence, the feel-good path, if you will. Rather, she suggests, he practice what he's preached to her ("reck not his own rede"). Groups claiming to represent good science in pursuit of noble social causes should heed Ophelia's advice to "reck their own rede" and put science foremost.

Do not, as some ungracious pastors do,
Show me the steep and thorny way to heaven,
Whilst like a puffed and reckless libertine
Himself the primrose path of dalliance treads,
And recks not his own rede.
Hamlet, act 1, sc. 3, l. 47-51

The image of this enjoyable garden pathway, so easy to traverse, but ultimately leading to misery, not heavenly bliss, is the modern reading of Shakespeare's dialogue. Most people would think of the primrose path as being a path ease and pleasure; the easy path out of a hard situation. It implies that those taking the enjoyable stroll down the path do so in ignorance, and those who lead others down the primrose path deserve condemnation for misportraying the journey as easy, since it will not lead to the desired destination and leave the travelers in a desparate situation.

So it is with the new FSA targets. Remember, the objective isn't to have an enjoyable stroll through food choices, the idea is to use those choices to reach the goal of improved health.

We don't subscribe to the notion that healthy diets must be filled with unpalatable choices; just the opposite. But a quality diet, especially in society today, isn't a primrose path where choosing the foods that look, smell and taste best are always the best for you. FSA has persuaded food manufacturers to reduce the salt level of their foods; that was the first round of targets. Food companies were eager to please and removing a portion of salt seemed like a stroll in the garden. Now comes the second round. Tougher targets. Challenging to technologists. Closer to the line on food safety.

Worse, although British consumers have played along and added more low-sodium foods to their shopping baskets, the British diet has the same amount of salt in it that it had 20 years ago (and, probably a good deal longer than that). The Intersalt Study published in the British Medical Journal in 1998 confirmed sodium intakes of about 150 mmol Na; the same as it is today (and in the middle of the same consistent intake range that has endured ever since we've had the technology to measure it).

Small wonder that FSA feels it needs a second round of tougher targets. It has made no progress to date. Food manufacturers should be warned that if they haven't recognized their situation as a classic "primrose path" they will eventually make the connection. Perhaps it will be the still more agressive targets of round three or round four. To paraphrase the expression: "Beatings will continue until morale improves." Targets will continue to tighten until public health responds.

Guess what? Public health IS responding, FSA just doesn't recognize the response. They are looking for sodium intakes to fall. Ain't gonna happen. But if they looked at total food intake, they'd find that the sodium-calorie ratio IS responding to their stimulus. Britons are choosing more low-sodium foods, but their intakes take their marching orders from their unconscious brain, not their conscious behaviors. They are following their hard-wired salt appetite and just eating more calories to get the salt their brains are signaling they need.

The "brains" at FSA are wrong. The brains in our bodies are, by design, right. Taking the easy primrose path and foresaking the "steep and thorny" path of scientific integrity is the wrong path. Thanks, Ophelia. I'm sure her father, Polonius, would endorse her pre-trip advice to his son Laertes just as he added his own: "To thine own self be true." Let's be true to the science and shun the primrose path.

Many government public health agencies recommend universal salt reduction. Unfortunate. Unjustified. But true.

In the past couple weeks, however, nutri-fascists have been spewing forth wild and scary allegations about the "toxic" level of dietary salt. Their fact-free rants may have cost them their customary agency support. At least one agency has said "enough" and issued a fact sheet that their population intakes are normal.

In fact, Food Standards Australia New Zealand went the extra step to explain that 95% of the residents Down Under are consuming less than 8.5 grams of salt daily. The statement was prompted by local WASH agitators who claimed Australians were "regularly" consuming 40 grams of salt per day. The release notes there are no recorded invidividual intakes over 26 g/day much less the 40 g/day whopper. FSANZ had to speak out publicly attempting to save their scientific credibilty (something about which WASH seems unconcerned).

The head of the Aussie WASH group was quoted in FoodNavigator saying: "The real question is whether government will take on industry." Actually, the real question is whether government will take on those who would frighten the public with irresponsible charges that their current salt intakes are poisonous. At a news conference a week ago the U.S. counterpart group, Center for Science in the Public Interest (CSPI) claimed highly-salted restaurant meals are excessive, even poisonous.

More and more evidence is being published about how moderate -- and stable -- population salt intakes are around the world. Activists have claimed high and rising salt intakes. Neither is true.

A couple months ago, the European Journal of Clinical Nutrition published a study of salt intakes in Denmark. The study of a representative sample of the Danish population found population sodium exactly those found in the U.S. (148 mmol Na) and the UK (149 mmol). In Denmark, the population consumes 147 mmol. Interestingly, the study by Anderson et al adjusted the male average (182 mmol) and female average (122) for caloric intake and reported:

no difference was found if total salt intake was measured per energy intake. No significant difference was found between sexes regarding intake of household salt, and neither the educational level nor the age was associated to either total salt intake or intake of household salt.

I guess the citizens of the U.S., U.K., Australia and Denmark didn't get the WASH talking points. If these activists continue to play fast and loose with the evidence, perhaps more public health agencies will be forced to issue statements like that from FSANZ as they try to preserve their credibility.

Today’s Wall Street Journal reports a recent study on “The Preventable Causes of Death in the United States: Comparative Risk Assessment of Dietary, Lifestyle, and Metabolic Risk Factors ” published online by the Public Library of Medicine. With scientists from major institutions and high powered statistical techniques, the study addresses the public health burden of a dozen “modifiable dietary, lifestyle, and metabolic risk factors” including dietary salt. Putting aside evidence that salt intake may not be “modifiable,” the authors tip off readers as soon as Table 1, footnote h that they’ve failed to take advantage of their opportunity to address this important question of mortality related to salt intake.

The footnote reads:

The effect of reduction in salt intake on SBP and the effect of subsequent decline in SBP on the relevant disease outcomes, were estimated at the individual level to account for possible correlation between salt intake and SBP.

Actually, there’s no need to read any further. The authors confine their concern for dietary sodium to extrapolated “benefits” based solely on blood pressure, totally ignoring both the two published studies of a randomized trial of the health outcomes of reducing dietary sodium and the entire literature of observational health outcomes studies which does not support the conclusion that SBP is the only relevant variable in determining disease outcomes. The authors term blood pressure a “disease outcome,” further weakening their credibility as examiners of mortality.

Even employing a fundamentally and fatally flawed methodology, they employ high powered statistics to examine the same question addressed earlier in the week by the Center for Science in the Public Interest which claimed salt caused 150,000 American deaths each year. This study puts the figure about 35,000 – wrong, but underscoring how fast and loose CSPI and NHLBI have been in playing with these projections.

Unfortunately, as has become the pattern, journalists pick up the news release and run with the story line. For example, Daniel Akst in the WSJ story reports:

Too many of us appear to be bent on slow-motion suicide. Consider smoking; if we could get every American to stop, we'd save 467,000 lives annually. Solving high blood pressure (much of it arising from unhealthy lifestyles) would save 395,000. And if we could get everyone to slim down to an appropriate body weight, we'd save 216,000 lives.

Great headlines. Lousy science.

Generals are often accused of preparing to fight the last war, not recognizing that events have moved on. The grand strategy of reducing the global burden of chronic diseases should remain our mission, to be sure, but we need to understand whether we’re using the right weapons in our battlefield tactics. The “last war” mentality is represented in the simplistic, one-size-fits-all campaign against blood pressure. Now we know there are many ways to reduce blood pressure. Some improve health; others, don’t. We used to bleed patients to improve their health. That certainly reduced their blood pressure. And many died. We used to urge pregnant women to reduce salt intakes; today that would be medical malpractice. Some interventions work to advance our mission of improving human health, other well-intended tactics have proved counterproductive, creating “unintended consequences,” like the 37% greater cardiovascular mortality among Americans consuming (recommended) low-salt diets. Think of salt reduction as waterboarding. Extreme, for sure. Some would argue unethical. But, bottom line, ineffective and possibly counterproductive.

Headlines across the country , and the world , alerting the public that the DASH Diet reduces the rate of heart failure. As champions of the DASH Diet for the past dozen years, we feel vindication. It was distressing, therefore, to read the authors’ news release declaring their study provides support for salt reduction among the dietary improvements. It doesn’t. Actually, it’s just the reverse.

Lead author Emily Levitan et al, explains about the findings published in the Archives of Internal Medicine , as reported by Science Daily :

"High blood pressure is always of concern because it has the potential to lead to major adverse events, including strokes, heart attacks and heart failure," explains senior author Emily Levitan, ScD, a research fellow in the Cardiovascular Epidemiology Research Center at BIDMC. She and her coauthors, therefore, hypothesized that the DASH diet (short for Dietary Approaches to Stop Hypertension) would also reduce a woman's risk of heart failure through its blood pressure lowering effects as well as its secondary effects on cholesterol and other heart-disease risk factors. The DASH diet, which has been shown to lower blood pressure in randomized clinical studies, is plentiful in fruits, vegetables, low-fat dairy products and whole grains. "These foods are high in potassium, magnesium, calcium and fiber, moderately high in protein, and low in saturated fat and total fat," explains Levitan.

So far, so good, but a news release referenced by Cardiology Today continues:

Emily Levitan, ScD, a research fellow at Beth Israel Deaconess Medical Center, said the women’s diet did not have to exactly mirror the DASH diet to have a benefit. “Very few of the women we looked at had diets that shared all aspects of the DASH diet,” she said in a press release. “But we found that the closer they were, the lower their risk of HF.

“This suggests that making even moderate adjustments to your diet to include more fruits, vegetables, whole grains and low-fat dairy products, and less salt and sugar and less red meat and processed meats, can help improve cardiac health,” she said.

Levitan ignores her own data. Like previous studies that have shown higher quality diets are not lower in salt, this new study does the same. The original DASH Diet, of course, held salt constant to eliminate the possibility that its results might be confounded by salt reduction. The ensuing DASH-Sodium trial added a salt reduction intervention and its (salt reductionist) authors refuse to divulge the data for analysis, but what has been reported suggests any salt effect applies only to a small number of people , at most. But this new study found the DASH Diet – high in fruits, vegetables and low-fat dairy products – had double digit changes to typical diets in terms of fat, saturated fat, cholesterol (all down) and potassium, calcium, magnesium and fiber (all up). That’s what you’d expect. The salt intake was virtually unchanged (<2%). The study also reports that the “high quality” NHLBI diet, which does recommend reduced salt intakes, had the same magnitude double-digit changes to fat, saturated fat (both down) and potassium calcium, magnesium and fiber (all up) and, in addition, recorded double digit increases in protein and sodium. Repeat, a double digit increase in sodium, not a cut. This was the actual diet of those adhering most closely to the recommended diet.

So, this further evidence confirms exactly the opposite point the authors’ report: the Archives study shows no link of reduced-salt diets with heart failure rate.

Until a year ago, that would have been surprising. Until last year, heart failure patients were routinely placed on low-salt diets. “Everyone” knew low-salt diets would be medically helpful. Except that “everyone” was wrong. The first-ever clinical trial of the health outcomes of low-salt diets was done among congestive heart failure patients . Guess what? Those on the low-salt diets had far worse health outcomes . They died and were re-admitted to the hospital much more frequently. A year later, you’d think researchers who found no association of salt intake with heart failure would have referenced the only two studies on this very point. Peer reviewers missed it.

Unfortunately, most of the reading public did too, according to the media play of the authors’ news release.

Newspaper reports from around the country have reported the warning which the FDA delivered to General Mills over its claims regarding the cholesterol-lowering benefits of Cheerios. The concern was that the claims being made about the cholesterol-lowering ability of Cheerios gave the indication that the product possessed almost drug-like qualities when, in fact, its ability to lower cholesterol was far more limited. In other words, anyone who is on statins or any other type of cholesterol-lowering therapy should never consider the claims as a justification to replace them by eating Cheerios.

Perhaps the strangest press release came from the newsroom of CSPI . They applauded the FDA for taking action against misleading and exaggerated health claims on foods. This statement came exactly one day after a news conference in which CSPI representatives Michael Jacobson and cohorts claimed that salt was toxic and that our current levels of consumption are prematurely sending countless Americans to their graves. Talk about exaggerated health claims!

CSPI has long been known for their wildly exaggerated and factually baseless tales of terror in the food industry. The organization's current fantasy is salt consumption. Ignoring all the data indicating that our cardiovascular disease performance has improved dramatically over the last 30 years; that countries which consume the most salt have the best cardiovascular figures; that the famous Mediterranean diet contains 30-40% more salt than the typical American diet; and that, even for salt sensitive people, significant reductions in salt consumption results in clinically non-significant reductions in blood pressure, they continues to rant of impending doom to anyone who will listen. The problem is that many do listen, but either cannot discern fact from fancy or are unwilling to do the follow-up research to verify the CSPI statements.

Dietitians are in consensus: diets are important. Individual nutrients, specific foods or single meals need to be considered as part of a person’s dietary pattern before they rise to the level of health significance.

For years, it’s been annoying to see the creeping acceptance of the contrary view, embracing a “good food/bad food” dichotomy based on the obvious fallacy that any food or any meal raises or lowers the likelihood of good or bad health outcomes. Groups like the Center for Science in the Public Interest (CSPI) take this wrong road right to the very end; their membership solicitations try to frighten the gullible into shunning “10 foods you should never eat.” Truth is: all of these foods can be part of a healthy diet. Not only is the variety of nutrients, foods and meals important, but examining dietary patterns allows consideration for the complex nutrient interactions that take place when we eat.

We’ve known the importance of healthy diets for centuries. Five years ago, Dr. Ashima Kant documented how dietary patterns (not foods, not meals) are related to chronic disease outcomes (JADA , 2004;104:615-35). Now, just in time for the 2010 revision of the Dietary Guidelines for Americans, two studies published in the past month offer further support to reversing the slide into the “good food/bad food” fallacy. Both employ rigorous scientific methodology to reach their conclusions. And those conclusions are:

• With regard to coronary heart disease there is “strong evidence of a causal link between CHD and dietary patterns ” with cohort studies demonstrating the protective effect of vegetables, nuts and monounsaturated fatty acids and three defined dietary patterns that incorporate these elements: the Mediterranean Diet and what Dr. Andrew Mente and colleagues at McMaster University call the “prudent” and “high quality” dietary patterns. On the other side, the current “western diet” and diets with high glycemic loads create health risks. Of these, only the Mediterranean Diet has been proven effective in randomized controlled trials. Think about all the dietary recommendations – and, even more, recommendations on various foods or types of meals – that are advocated constantly but which lack a foundation in medical science.
• Using dietary recall to evaluate dietary quality is difficult, so a simple surrogate indicator, a biomarker, would be a valuable aid to determine if our individual – or our population – diets are meeting our quality objectives. And now such a boimarker has been validated . That marker is urinary potassium. The higher the urinary potassium, the better the diet. Given that sodium is the electrolyte that’s been accorded the most emphasis (on food labels, in advertising, etc.) the researchers also examined urinary sodium as a marker of diet quality. They found sodium to be a poor surrogate for overall dietary quality (despite the fact that the model included a sodium component whereby higher sodium intakes would be “unhealthy” so that modeled disadvantage was overcome by other dietary factors). Dr. Mente, this time with a team at Toronto’s Mount Sinai Hospital, conducted the analysis. They concluded that “a single 24-h urinary K+ measure is a clinically valid, simple, and inexpensive ($10.00 in Canada) test of overall diet quality.”

So, when you hear CSPI or some other do-good advocate suggest that eating a particular food or avoiding another is good for you, take it with a grain of salt. If they tell you that meals with too much of any nutrient (sodium, certainly, but also fat or some other target of opportunity) is bad for you, tell them to read the science first.

The Mediterranean Diet, the only one proven in controlled trials to actually improve health, has about 30% more salt than the average American diet today. Perhaps coincidentally the only randomized controlled trial of the health outcomes of a low-salt diet was also done in Italy. It confirmed that low-salt diets not only failed to deliver expected health benefits, but actually placed those cutting back on salt at additional risk.

Perhaps the quality science pushing forward our understanding of the importance of dietary patterns and overall diet quality will displace the loud, but scientifically-unsupported calls to cut out this nutrient or that, forego eating traditional and tasty foods and avoiding meals that don’t pass muster with the food police.

At the bottom, I'll fill-in-the-blanks (asterisks), but see if you don't see how accurately this reports the situation when the Salt Institute and US Chamber challenged HHS with a Data Quality Act petition on the DASH-Sodium study.

* Suit Says Law Requires Federal Agencies To Use Sound Science
Appeal Argues Statements on ** Must be Accurate

On April 14, the federal Ninth Circuit Court of Appeals heard arguments from * on why such federal agencies as Health and Human Services (HHS) and the Food and Drug Administration (FDA) must correct the inaccurate information they disseminate about **.

In late 2007, a lower court accepted the government's contention that there is no right to judicial review under the Data Quality Act, effectively reducing the law a friendly request, without ruling on the merits of *'s claims.

Arguing on behalf of *that the laws Congress passes have consequences that federal agencies cannot ignore was noted legal scholar Alan Morrison, who founded Public Citizen's Litigation Group and taught administrative law at Stanford. "Citizens have a right to expect the government to be transparent and to use the best available information for policy decisions," said Morrison. "Unfortunately, so far, the government has been anything but transparent and has failed to produce any evidence for its policy statements on **."

While the law says federal agencies must rely on sound science when disseminating information to the public, the petition filed by * in October 2004 marked the first serious test of the Data Quality Act, which was passed by Congress in 1999. After more than two years of delay by the federal government that culminated in a refusal to act on the petition, * filed a lawsuit in February 2007 asking the courts to direct the agencies to comply with the law.

The respected magazine Science published an editorial on the case that year, claiming that HHS had "violated its own DQA guidelines."

At issue are such statements as "there have been no studies that have scientifically assessed **"We welcome the Obama Administration's recently stated commitment to making policy decisions based on science, not politics," said ____, Chief Counsel with *. "This case is designed to ensure that the federal government's policy on ** is not politically motivated."

On March 9, 2009, President Obama issued a memorandum to the heads of executive departments and agencies stating that, "The public must be able to trust the science and scientific process informing public policy decisions," and calling for "transparency in the preparation, identification, and use of scientific and technological information in policymaking."

During oral arguments, attorney for the government told the three-judge panel that there were simply too many facts in the world to require the government's statements about them all to be accurate.

We'd only note that we think our Salt Institute v. Leavitt was the "first serious test of the Data Quality Act," but, otherwise this newsletter from *Americans for Safe Access (ASA) about **medical marijuana reads like a sequel to our attempt to compel HHS to comply with the DQA and make available replicable data it was using for policy decisions and (mis)portraying on its website.

We hope ASA fares better than we did. The appeals court in our case upheld, in the language of the ASA newsletter, "the government's contention that there is no right to judicial review under the Data Quality Act, effectively reducing the law (to) a friendly request without ruling on the merits." Good luck.

Every day, we learn more and more about the metabolism of salt and mechanism of its role in maintaining balance or homeostasis within our circulatory system. Some of the most interesting work continues to come from a Europe-wide collaborative group based in Germany. Their latest work entitled, “Macrophages regulate salt-dependent volume and blood pressure by a vascular endothelial growth factor-C–dependent buffering mechanism,” was just published online by Nature Medicine .

This new data provides valuable insights into the role of the mononuclear phagocyte system (MPS) cell and lymphatic function in the context of maintaining intracellular Na+ homeostasis. Cells of the mononuclear phagocyte system (MPS) are found in large numbers in every organ of the body, where they contribute to innate and acquired immunity and fluid balance. When rats are fed high salt diets, the extra accumulation of sodium ions that occurs in excess of compensating water results in local hypertonicity or increased pressures that provokes a tissue-specific regulatory cascade, with the macrophages releasing vascular endothelial growth factor-C (VEGF-C) which acts protective protein to maintain a constant intracellular volume. This mechanism then restructures the existing lymph capillary network and to manage this increased pressure.

The researchers conclude that the complex MPS-derived secretion of VEGF-C in states of sodium-induced intracellular hypertonicity functions to moderates blood pressure.

Their findings move the prevailing view of the salt volume–blood pressure relationship from a simpler two-compartment model to a more dynamic three-compartment model in which the interstitial (intracellular) spaces in tissues feature as a separately regulated space that also relies on tissue-specific mechanisms to maintain internal osmo- or pressure regulation.

While we caution that this work was done with rats -- and at experimentally huge salt intake levels to demonstrate the mechanism -- and, therefore, has no human health policy implications at this point, the study usefully reveals how complex a system we have evolved to manage and balance all components of our diet.

Mort Satin and I today filed a letter (pdf 103.06 kB) with the Dietary Guidelines Advisory Committee lamenting their decision to convert a public meeting next week into a webinar with no face-to-face interaction. We told the DGAC:

This runs directly counter to the Administration’s encouragement of greater transparency. We earlier registered our continued disappointment that the Committee has turned its back on another Administration commitment – to improve the process in considering science. By not pre-defining quality standards for inclusion in the evidence-based review process being utilized, the Committee invites the same kind of selective, expert opinion criticisms leveled at earlier panels.

Our letter registered process concerns on several issues:

1. Failure to upgrade to a true evidence-based process as recommended by the Institute of Medicine, the U.S. Preventive Services Task Force and the Cochrane Collaboration.
2. Failure to insulate against the prejudicial policy bias of DGAC leaders. We pointed out how the 2000 Guidelines had reversed course on its recommendations for fat when they determined "the recommendation to lower fat intake had been ill-advised and might actually create harm." With leaders pre-judging the issue, the DGAC will find it difficult to ease the salt guideline to reflect the failure of scientific studies to identify a health benefit.
3. Some DGAC members seem to equate salt "disappearance" data with human consumption, but government and university research shows that between 27% and 50% of foods are wasted and many food technologies using salt do not result in that salt ending up in the final product. We offered as examples of "wastage" that 80-90% of salt in koshering meats, 60-80% used in cheese curing, 80-95% used in processing frozen vegetables, 75-80% used in canning, 75-80% used in preparing pickles, sauerkraut and olives, 60-75% used in salting fish and 85-90% used in home cooking water for pasta, vegetables, etc. is discarded after the food is prepared and not ultimately ingested. Overall, we estimated 30-50% shrinkage.
4. We reminded Committee members that any successful replacement of salt in food products would require massive use of salt substitute chemicals with long chemical names that consumers might find problematic since none have been tested in the huge amounts that would be ingested if large-scale salt replacement was achieved.

Today's Wall Street Journal carried a story on "Why we need less sodium." While the question may provoke different opinions, I'm reminded of the observation that everyone is entitled to their own opinion, but nobody is entitled to their own facts.

The article collects oft-repeated myths, perpetuating public confusion. Consider:

• Americans consume the average amount of salt of societies around the world. The article states we consume "15 times" too much. The National Academy of Sciences says humans can survive on 500 mg. But good health requires more.
• The article states that salt intake has increased “50% since the 1970s.” The truth is that per capita salt intakes haven't increased at all. Not since the 1970s and not in the past century. That’s a total fabrication.
• Thus, the implication is that we eat too much salt. That is unfounded. Those with the best health outcomes consume salt at current levels. At the government’s “recommended” 2,300 mg level, cardiovascular mortality is actually higher, more than a third greater (37%), according to the federal government’s own National Health and Nutrition Examination Survey.

National policy should be based on more than opinion and that there should be a controlled trial to establish whether reducing dietary salt improves health. Evidence-based groups like the government’s U.S. Preventive Services Task Force and the Cochrane Collaboration which invented the concept, have concluded that there is insufficient evidence to ask everyone to reduce salt. Unfotunately, the article doesn't even hint at the controversy among expert scientists.

Elsewhere we cover the first rigorous examination of possible causal links between diet and heart disease . The study appeared in the April 13 edition of the American Medical Association's Annals of Internal Medicine . Its authors are with McMaster University in Hamilton, Ontario, the Canadian epicenter of "evidence-based medicine."

The authors provide context noting: "The relationship between dietary factors and coronary heart disease (CHD) has been a major focus of health research for almost a half century." The vast literature with discordant results, however, "has generated confusion among health care professionals, policy makers, and the population at large who are interested in this information to aid them in CHD prevention strategies."

The study sets the standard for evidence-based reviews and is entirely different from the approach being utilized right now by the U.S. Dietary Guidelines Advisory Committee which is utilizing the old traditional "expert panel" approach. Referencing the 2005 US Dietary Guidelines (and equally applicable to the ongoing 2010 revision process), the authors lament:

....little direct evidence from RCTs supports these recommendations. In come cases the RCTs have not been conducted, and RCTs that have been conducted have generally not been adequately powered or have evaluated surrogate end points rather than clinical outcomes. Despite this lack of information evidence-based recommendations derived from cohort studies have been advocated. This is cause for concern because dietary advice to limit the intake of a certain nutrient (i.e. dietary fat) may result in increased consumption of another (i.e. carbohydrates), which can have adverse effects on CHD risk factors. Moreover, without large prospective studies in which multiple health outcomes are evaluated, recommendations to modify a dietary component may decrease teh likelihood of one chronic disease (i.e. CHD) at the cost of increasing another (i.e. cancer)

The authors conclude that there is

strong evidence of a causal link between CHD and dietary patterns. Population-based cohort studies have demonstrated the protective effect of a quality diet against CHD and all-cause mortality. ...Dietary patterns have the advantage of taking into account the complex interactions and cumulative effects of multiple nutrients within the entire diet....

This study should become required reading for the Dietary Guidelines Advisory Committee which seems to be retreating both from objective science and transparent process. As these authors note: "Our study has a number of strengths because we undertook several measures to minimize bias" (which it proceeded to discuss). In contrast, the DGAC appointed an anti-salt zealot, a member of the rabidly anti-salt WASH advocacy group, to chair its salt subcommittee. So much for "measures to minimize bias."

Oh, and by the way, the study found

strong evidence of a causal relationship for protective factors including intake of vegetables, nuts and monounsaturated fatty acids and Mediterranean, prudent and high quality dietary patterns, and harmful factors, including intake of trans-tatty acids and foods with a high glycemic index or load and a western dietary pattern. Among these dietary exposures, however, only a Mediterranean dietary pattern has been studied in RCTs and significantly associated with CHD.

If trhat sound like what regular readers of the Salt Institute's Salt and Health newsletter have been reading about in recent years, particularly about the true nature of evidence-based reviews , how those standards are perverted in the US Dietary Guidelines process and the importance of dietary patterns , we hope that's because we, too, try to be evidence based -- but we cannot claim the exemplary rigor of these researchers who clearly practice what they preach.

The latest trend exposed by the NPD Group’s 23^rd Annual Report on Eating Patterns in America , is the focus on adding healthful ingredients to diets, rather than limiting food items. The percentage of adults supplementing their diets with beneficial ingredients such as whole grains, fiber, antioxidants and Omega-3 fatty acids has been increasing since 2005. According to NPD, a market research firm, the percentage of consumers trying to eliminate trans-fats, cholesterol, sodium, caffeine, sugar and carbohydrates has declined drastically since the late 1980s and early 1990s.

According to NPD’s report, the number of dieters reporting that they are adhering to a low salt diet has decreased significantly since 2001, when 5.4% indicated they were on a low salt diet. In 2008, only 3.4% of dieters reported adhering to a low salt diet.

Despite the efforts of the “food police” and alarmists who focus on single dietary items rather than whole diets, it appears that an increasing number of Americans are taking a more common sense approach to their overall diets. Bombarded with a constant barrage of mixed messages regarding nutrition perhaps they are getting back to the basics that most of us heard at the dinner table growing up: “Eat your vegetables so you will grow big and strong.” “Don’t eat too many cookies or you will get fat.” Note that our parents didn’t say, “Eat only vegetables” or “Don’t eat ANY cookies”. Yet public policy makers often take extreme approaches that make our parents look like they were complete pushovers.

Ultimately a vast body of data supports what our parents told us. We should eat a well balanced diet rich in vegetables, fruits, whole grains, low-fat dairy and lean meats. There is not one magic ingredient in our diets to make us healthy and there is not one “poison pill”. Or as my grandmother would say, “All things in moderation.”

A new publication in this week's Annals of Internal Medicine illustrates the importance of distinguishing evidence-based reviews from more political conclusions by expert groups as employed, for example, in the creation of the US Dietary Guidelines or the World Health Organization's diet recommendations. Andew Mente, et al released "A Systematic Review of the Evidence Supporting a Causal Link Between Dietary Factors and Coronary Heart Disease ." They followed an examplary procedure, defining how they would analyze the evidence before actually digging into the subject content of any of the studies. First they identifed 5,705 medical journal articles on diet and heart disease. They then applied pre-established rules on their strength, consistency, temporality (exposure before outcome) and coherence, and then considered biological gradient, experimental evidence, specificity (avoiding multiple risk exposures), biological plausibility and the avoidance of analogy. These comprise the rigorous Bradfor Hill Criteria for Assessing Causation.

The "blind" screening process netted 146 prospective cohort studies and 94 randomized controlled trials that were then analyzed to answer the question: what does medical science tell us about diet and heart disease? The results of the study, in the authors' words:

Strong evidence supports valid associations (4 criteria satisfied) of protective factors, including intake of vegetables, nuts, and "Mediterranean" and high-quality dietary patterns with CHD, and associations of harmful factors, including intake of trans–fatty acids and foods with a high glycemic index or load. Among studies of higher methodologic quality, there was also strong evidence for monounsaturated fatty acids and "prudent" and "western" dietary patterns. Moderate evidence (3 criteria) of associations exists for intake of fish, marine -3 fatty acids, folate, whole grains, dietary vitamins E and C, beta carotene, alcohol, fruit, and fiber. Insufficient evidence (2 criteria) of association is present for intake of supplementary vitamin E and ascorbic acid (vitamin C); saturated and polyunsaturated fatty acids; total fat; -linolenic acid; meat; eggs; and milk. Among the dietary exposures with strong evidence of causation from cohort studies, only a Mediterranean dietary pattern is related to CHD in randomized trials.

Some interpreted the finding as disappointing because the evidence found only a limited number of dietary causes of heart disease -- unlike the huge number of alleged relationships read about in the newspapers almost daily. As USA Today summed it up: "What we know for sure about diet and what protects the heart is a relatively short list." The Systematic Review validated the Salt Institute's dietary advocacy: a quality diet embodying the Mediterranean Diet without regard to any concern about salt intake is the best thing for heart health. No evidence implicated salt as a cause of coronary heart disease.

Rather than disappointment, we should cheer the conclusion that "evidence supports a valid association of a limited number of dietary factors and dietary patterns with CHD." Since we've been largely unsuccessful in changing Americans' dietary patterns, having greater agreement on a limited number of interventions that are proven effective sounds like a real breakthrough to us.

Dr. Steven R. Covey, management guru, teaches as one of his "Seven Habits" to "begin with the end in mind." The key here is that the focus of science and health is the end of preserving the integrity of the science by rigorously following quality scientific methods. The "end" is not finding evidence to support a pre-determined policy preference. Thank you, doctors, for this outstanding reminder that process can determine outcomes and that data-driven conclusions are far more valuable than expert opinion.

Stay tuned to see how the experts on the Dietary Guidelines greet this study.

Mort Satin, Director of Technical and Regulatory Affairs at the Salt Institute addressed the Institute of Medicine 's Committee on Strategies to Reduce Sodium on March 30 at their 2nd Information-Gathering Workshop . He cautioned the Committee to use great caution and to read all the peer-reviewed scientific and medical literature before making any recommendation for a population-wide reduction of salt intakes. He stated that "you cannot simply reduce salt - salt has to be replaced or enhanced with something else and once you begin to modify flavor profiles, you embark on an endless journey of adding nuances and counter-nuances to correct off-flavors or dis-functionalities introduced by the previous additive, until you are left with a cocktail of complex industrial chemicals in the final food product. The very concept of replacing salt with an arsenal of synthetic chemical that have never been tested for their interactions and toxicities at the levels they are projected to be consumed at, if they replace salt, is highly questionable. It is no different than replacing animal fats with trans fats or cane sugar with the several unpronounceable industrial chemicals we call sugar replacers today. All these chemical replacers distort the consumer’s perspective and promote greater overall consumption of food. Sooner or later, a fuller understanding of their toxicities will be revealed, and it is this Committee that will have to bear the responsibility for the ill-conceived strategy that prompted their widespread adoption."

You can read the full statement here (pdf 98.90 kB) .

Will President Obama's actions match his lofty rhetoric? He has charted an ambitious course. He is pursuing nuclear disarmament while North Korea launches ICBM missles. He's ended the "War on Terror" and apparently extending U.S. civil rights to law-breakers like the Somalian pirates. At home, he's promised the biggest spending program in history while being able to cut the deficit by half, all paid for by raising taxes on just 5% of American taxpayers. Lofty -- and oft-lauded -- rhetoric. A lot of these issues won't be sorted out in the near term.

Another rhetorical flourish, however, will be tested this coming Tuesday, April 14, in a federal appeals courtroom in California . Pres. Obama has promised major changes in his Administration to reform the way the federal government uses science . This was to include the Freedom of Information Act and other changes to federal policy to ensure that public policy follows the science. "Restoration" of scientific integrity resonated during the campaign. Now comes the acid test: a court case on the Data Quality Act.

The issue is medical marijuana . That's not a Salt Institute issue. The Salt Institute's issue is the statute being tested: the Data Quality Act (DQA). Signed into law by President Clinton, the DQA affirms that no federal policies will rely on scientific data that does not meet certain quality standards, among them that the data are available for independent verification.

Unfortunately, during the last Administration, the Department of Justice controverted the intent of the law and convinced a federal appeals court in the 4th district in the case, Salt Institute v. Leavitt , that the Data Quality Act was not judicially reviewable. The bureaucracy would determine for itself if its data followed the statute's strict requirements. The government had been asked to produce for independent review rudimentary statistical analysis of the DASH-Sodium study which it was using as justification for the 2005 Dietary Guidelines. Not wanting to divulge the information, the Department of Health and Human Services denied a DQA petition from the Salt Insitute and the U.S. Chamber of Commerce and refused to reconsider it on appeal. The court decision to leave the matter with the agency totally neutered the statute and, doubtless, contributed to the Adminstration's alleged arrogance in subverting science.

Now comes the DOJ again to court in a case that many Obama partisans support -- opening up use of medical marijuana. The argument is made that the government has no compelling data to deny states the right to allow the practice. Will DOJ on Tuesday adopt the stance of the former Administration that "Uncle Sam knows best" what data should be allowed into the policy discussion? Or will the new Obama DOJ implement the lofty ideals espoused by the President that scientific integrity be restored and only high quality data be the basis for federal policy.

The larger issue was captured in a "Power and Control " blog today by"M. Simon of Rockford, IL" noted in today:

It would seem that the Federal Government and Congress have not been keeping up. Justice Clarence Thomas got it right in a medical marijuana case (Raich) when he said

"Congress presented no evidence in support of its conclusions (that marijuana has no medical value - ed.) , which are not so much findings of fact as assertions of power," and Thomas concludes: "Congress cannot define the scope of its own power merely by declaring the necessity of its enactments."

So, who's in control? President Obama with his ideals? Or the federal bureaucrats who seek to avoid accountability by thwarting the Data Quality Act and its lofty, laudable requirements that federal policy follow the science. It doesn't take a new law. We hope it doesn't take a "Saturday Night Massacre" at the Justice Department to make the right moral choice.