Carefully coordinated, even choreographed, the anti-salt campaign launched another publicity barrage today, announcing that the UK CASH (Consensus Action Against Salt) has been superseded by WASH, the World Action Against Salt. CASH experts (Dr. Graham MacGregor, et al) will be in Paris tomorrow and Friday, having persuaded the World Health Organization to host a one-sided symposium on salt to build pressure for action. The announcement was made in foodnavigator.com .

Meanwhile, the science is unchanged, trending against WASH as public health agencies consider whether their earlier focus on the blood pressure effects of salt reduction should remain the scientific focus or whether, as advocated by the presidents of the International Society of Hypertension and American Society of Hypertension, the focus should broaden to consider whether reducing dietary salt will improve public health .

Researchers from the University of California at Berkeley argue in an article published yesterday in the British Medical Journal recommending the "Parachute approach to evidence based medicine ," that there are times when it is unethical to wait for controlled trials of a health intervention. People die before the intervention is tested, they say, citing as their most impressive evidence the case of Oral Rehydration Therapy (ORT). They explain:

In 1980 childhood diarrhoea was killing an estimated 4.6 million children annually. Treatment with an intravenous drip is life saving but requires health facilities. Studies from 1977 onwards showed that infant diarrhoea could be treated with oral rehydration. The World Health Organization initiated a highly successful programme of oral replacement therapy in 1981 after it became obvious that the treatment saved lives and no alternative home based treatment was possible. Randomised controlled trials were later conducted in health facilities, confirming that oral replacement therapy was as effective as intravenous therapy. The initiation of large scale programmes for oral replacement therapy before the randomised trials meant that by 2000 there were three million fewer deaths from diarrhoea annually.

Treating diarrhea with a mixture of salt, sugar and water has, indeed, saved millions of lives. The authors advocate the "parachute" principle, explaining:

Evidence based medicine and randomised controlled trials are not synonymous. The parachute approach can be the most appropriate, especially in situations of high mortality and low resources, when a simple intervention can have a large impact. Randomised controlled trials are essential in many other settings and they have defined many life saving strategies and corrected some important mistakes. They are often needed when mortality has reached a low level because new treatments require large investment for relatively small improvements in therapy that may be difficult to distinguish.

All that may be well and good, but BMJ has also editorialized that they feel confident in recommending universal sodium reduction. Perhaps a caveat is needed before we call in the airborne assault on salt. In the case of ORT, the small scale studies produced strong consensus of a health benefit. While there is no such concensus that reducing salt would reduce blood pressure to a meaningfull degree, because the effect is so heterogeneous, the UC-Berkeley authors and BMJ editorial staff should be chastened by the consensus of the observational studies of low-salt diets -- there is no benefit in terms of reducing heart attacks or reducing mortality.

Let's not "parachute" in to reduce dietary salt -- at least until the clouds clear and we can see the landing area.

Used to be all dietitians would chant the mantra of varied diets where all foods could find a place. "We need to focus on the question of "good diets" and "bad diets," they'd say, and avoid labeling individual foods as "good foods" or "bad foods."

The science is unchanged, but the mantra is gone. When nutrition experts gather these days, they're shaking their heads and wringing their hands: the public doesn't "get it." While consumers pretty well understand the concepts of the dietary guidelines, they don't buy into them in terms of personal eating decisions. What to do?

Demonize foods, say some like the Center for Science in the Public Interest which has pushed the "good food/bad food" dichotomy for 30 years. Make people feel that the foods they eat are poisoning them. Ostracize foods with "bad" nutrients and limit diet choices to "good foods" with plentiful "good" nutrients.

The food industry is buying into the "good foods/bad foods" story too -- for marketing reasons. Food companies want to deliver what their customers want. If you can put a "healthy" label on your foods, it makes a difference in product placement and sales -- if you can make it taste good!

A new study reported by the European Food Information Council sums up this way:

There is widespread interest for nutrition information on food packages. Consumers generally understand the link between food and health, and many are interested in using information about the nutritional properties of the food they eat. However, the degree of interest differs between consumers and varies across situations and products. In addition, it can conflict with other interests in food, notably taste, traditional eating, and indulgence.

Consumers like the idea of simplified front-of-pack information but differ in their liking for the various formats. These include health logos, 'traffic lights', GDA-based systems and energy labels. Differences can be related to conflicting preferences for ease of use, being fully informed, and not being pressurised into behaving in a particular way. For example, many consumers like colour coding, but some regard reds and greens on food products as too coercive.

Most consumers understand the most common signposting formats in the sense that they themselves believe that they understand them and they can replay key information presented to them in an experimental situation.

There is still virtually no insight into how labelling information is, or will be, used in a real world shopping situation, and how it will affect consumers' dietary patterns.

The real question is will food buyers follow the red-yellow-green stoplight the same way they follow traffic speed limits -- by applying their own judgment in the absence of an officer writing speeding tickets? As EUFIC points out: "There is still virtually no insight into how labelling information is, or will be, used in a real world shopping situation." Are we ready to buy another set of unintended consequences?

The latest issue of Food Technology, the foundation publication of the Institute of Food Technologists has an article in the Food, Medicine & Health section devoted to the issue of salt and hypertension. The knee-jerk response by certain regulatory agencies to very limited and inconclusive evidence is highlighted along with the dangers of developing policies based on the vocal opinions of a few commited anti-salt advocates. The authors, Clemens and Pressman, go out of their way to remind us that that hypertension is not a discrete disease nor is it a clinical end point, but rather a multifaceted risk factor steeped in myth-information and too-often passed off as a proxy for cardiovascular disease - a misleading representation.

More articles like this one, in widely circulated journals pointing will get rid of the hype and reduce the tension in the whole hypertention debate.

As Mort blogged earlier this morning, the Salt Institute gets calls constantly from the media. In an exchange yesterday with another Chicago area reporter writing on salt and health, I drew an analogy that may help explain the basic point of the Salt Institute's advocacy on salt and health. See what you think.

We argue that the relevant question that should be asked with regard to a public health advisory to reduce dietary sodium is "Will cutting salt intake improve health?" Instead, some frame the question as "Will cutting salt improve blood pressure?" They aren't the same thing. When you cut salt, you "buy" all the consequences, intended and unintended, that are triggered as the body recognizes it is consuming less salt.

I likened public confusion on the issue with the current flap over national security policy. Those who characterize our national security challenge as combatting terrorism have a very different worldview from those who define our challenge in terms of our engagement in Iraq. It's not a matter of patriotism; it's a matter of focus and context.

In the war against cardiovascular mortality, some would test our weapons systems for their impact on overall health and mortality; others would focus on the specific problem of blood pressure. Without doubt, blood pressure is related to cardiovascular health, but it is one of several important "theaters." It's important to identify specifically and correctly our rules of engagement before we sally forth to meet the enemy. We want to avoid any "friendly fire" casualties.

Unfortunately, experts lack consensus over the right questions to ask in both challenges: national security and cardiovascular health.

My "in" box is filling up today with news on salt and exercise, interupting (and affecting) my final edits on a story on salt and obesity. First, CBS Radio News medical consultant Dr. Gabe Mirkin wrote calling my attention to his "August" article (all senses of the word) "Why You Need Salt During Exercise " followed closely by an article filed today by Ivana Bisaro, "See Salt: You Need More Sodium Than You Think ." The Bisaro article was perfect for hot August days, reminding us of the new guidelines presented by the American College of Sports Medicine calling for replacing 500-700 mg of sodium and 3/4 to 1 liter of fluid for every hour of exercise. ACSM warns to pay special attention to getting enough salt if your sodium intake is less than 3,000 mg day (US average = 3,500 mg, but some recomend 2,300 mg, below the ACSM warning level). The US Dietary Guidelines call for a half hour of at least moderate exercise a day beyond normal activities. When it's hot outside, you may need even more than the 250-350 mg of sodium called for by the ACSM.

House Energy and Commerce chair Joe Barton (R-TX), the committee's ranking minority member John Dingell (D-MI), oversight subcommittee chairman Ed Whitfield (R-KY) and Rep. Bart Stupak (D-MI) have called on the National Institutes of Health to come clean on conflicts of interest at the agency. The Los Angeles Times reported that the letter is focused on the activities of NIH cancer researcher Dr. Thomas J. Walsh and involves his receipt of corporate support and his appearance at regulatory hearings related to his corporate sponsors.

The effort remains the tip of the larger iceberg. Current regulations address the issues of financial conflicts with for-profit organizations, but conflicts of interest inherent in both funding and professional advancement growing from support by NIH itself is a big (perhaps, bigger) concern because its subtlety has the same effect: determining policy that may support private interests and agendas more than the public good.

In previous posts, I've noted that concern for investigator bias is a serious threat to the integrity of medical research -- and public confidence in the results. It's getting to the point of "piling on" for the Wall Street Journal and the editor-in-chief of the Journal of the American Medical Association to add their strong voices to the crescendo of the chorus.

But it's a lot like the future funding for Social Security: everyone recognizes a serious problem, but sometimes the remedies suggested are half-measures that will surely only paper-over the fundamental problem.

Last Friday, the Wall Street Journal ran a story "Simply Disclosing Funds Behind Studies May Not Erase Bias " about how researchers would likely deal with toughened disclosures of financial ties to for-profit firms. Tuesday, Catherine DeAngelis, JAMA's editor-in-chief weighed in with a powerful salvo in "The Influence of Money on Medical Science ." Of course they're both right. Bias is a cardinal sin and must be stamped out.

Unfortunately, the remedies being discussed are focused narrowly on bias from a for-profit funding source. They ignore the bias based on funding from a non-profit or government source, though that influence can be even more pernicious because the public is gulled into believing the sponsors genuinely represent the "public interest." The truth is, there are policy and bureaucratic biases fully as important as taking money from a drug company or medical device manufacturer.

Sure, let's deepen our concern -- but let's widen it as well!

The Journal of the American Dietitic Association has just published a study suggesting that low-energy-dense diets lead to lower overall calorie consumption. Evidence in both human and animal nutrition suggest that mineral-dense diets are associated with body leanness. It is the general consensus of nutrition professionals that our diet would be improved if it contained fewer calories and more more minerals, so the stars seem to be lining up for the "high quality" DASH Diet, developed for blood pressure reduction, but seemingly appropriate to solving a myriad of dietary problems. Could it be that sodium isn't just irrelevant (DASH), but actually part of that "high quality" mineral-dense diet?

I've blogged on the subject of research integrity and conflicts of interest by researchers and research funders -- whether they be pharmaceutical companies or government health agencies. This past week, Dr. David A. Shaywitz, an endocrinologist at Mass General Hospital, weighed in with a helpful op ed piece in the Boston Globe. Said Shaywitz: "The quaint notion that university researchers operate on a higher moral plane than business people might be charming if the implications weren't so profound: attention-getting results can lead directly to employment, promotion, and prizes, all leading to personal gain. Not surprisingly, some of the most notorious perpetrators of research misconduct have been academic investigators with no company relationships." Shaywitz doesn't offer the funding source for those "with no company relationships," but it seems clear: government agencies.

Shaywitz concludes sagely:

Coming up with novel treatments for dreadful diseases is a difficult enough task under the best of circumstances; let's not complicate this mission further by misjudging either the intrinsic virtue of academic scientists or the alleged venality of drug companies; instead let us learn how to foster productive, transparent collaborations so that the promise of modern science can be realized inthe treatment of our patients.

Nice touch, ending with a call for a health outcomes focus.

FDA announced today it will act to safeguard the integrity of its advisory commitee process "to provide greater clarity and transparency in the disclosure of waivers of relationships that could present the appearance of conflicts of interest."

Recognizing that important expertise lies outside the realm of government scientists, agencies with scientific policymaking roles (HHS, EPA, DOL, etc.) routinely employ outside advisory panels. With appropriate safeguards they well serve the public interest.

The FDA news release continues:

"The advisory committee process is integral to examining the intersection between medical practice and clinical research, to spark debate about it, and to subject scientific work to close public scrutiny," said Dr. Scott Gottlieb, FDA's Deputy Commissioner for Medical and Scientific Affairs. "Some of the most valuable input often comes from people who are active practitioners but also heavily engaged in clinical research and we need to make sure that we continue to have the ability to recruit top clinical trialists."

FDA believes it is crucial that the public have complete confidence in the integrity of the advisory committee process. Therefore, in the next few months, the agency plans to take the following steps to help ensure that our advisory committees continue to be scientifically expert and independent and that the advisory committee process is transparent:

Issue a guidance identifying more clearly the conditions under which conflict of interest waivers are granted. Currently, for example, waivers can be granted to committee members under certain circumstances for participation in scientific endeavors related to the work of the committee, as well as for certain unrelated activities. Issue a guidance specifying when waivers of conflict of interest will be disclosed to the public and what information will be made available.

Issue a guidance specifying when briefing materials used at advisory committee meetings will be made publicly available.

Provide greater public dissemination of advisory committee schedules through increased mailings to public groups, and providing electronic notifications through an FDA advisory committee list serve and posting on the FDA web site.

Implementation of a more streamlined approach to the appointment of members to the agency's drug-related advisory committees.

Unfortunately, the plan has an enormous blind spot. As we observed a couple weeks ago when the Journal of the American Medical Association also sought to preserve its integrity:

JAMA's new rules are fundamentally flawed. They limit consideration of financial conflicts of interest to those with funding ties to private industry, totally ignoring the fact that many researchers sustain their professional careers fulfilling the agendas of government health agencies. Major studies can bring in nine-figure grants or contracts and lead to career-enhancing publications, professional visibility -- and more grants. Public health agencies have their own special interests, including promoting favored public health strategies. These are not disclosed and rarely considered. But they're real.

FDA would do well to introduce transparency and safeguards into the process by ensuring that its advisors' funding ties to the Agency itself and to other government funding sources be fully disclosed as well as those to private industry. Whether the dollar is provided by a taxpaying, for-profit organization, a tax-exempt "public interest" organization or a tax-funded agency, we need to recognize that these institutions all have agendas and bias. Full disclosure and rigorous attention to research quality will be required.

CBS News correspondent Andy Rooney has a way of speaking for the common man. Yesterday, "60 Minutes" revisited a 1996 commentary where Rooney complains about the difficulty consumers like him would have choosing a low-sodium diet. You can read the transcript or watch a video clip of "Diet Guidelines Get Andy Salty " online.

Presumably, Rooney is supported by a research staff that should protect him from such gaffes as equating salt and sodium. Instead, this "common man" highlights that ignorance, suggesting that he feels normal consumers have a hard time with the distinction (yes, Andy, they are different; about 40% of salt -- sodium chloride -- is sodium and the other 60% chloride). Interesting. He concludes, observing that the American Heart Association advises against more than one stalk of celery n a pot of stew; "the other day at a party I ate two stalks of celery so, if I'm not on next week because I dropped dead, blame that second stalk of celery."

Respect for authority, of course, doesn't lead to compelling, humorous commentary, so there are likely many who share Rooney's disdain for such dietary strictures. Where needed, then, the credibility of advice to reduce dietary sodium is undermined because of the over-reaching, picayune nannying delivery of what may be life-saving advice.

Whether the advice is life-saving is the real question. Difficult as it may be to effectuate a low-sodium diet, the real question is the other side of the equation: why reduce sodium in the first place? Most Americans consume a moderate sodium diet (3,500 mg sodium, right in the middle of the global average and about midway in the 2,300 - 4,600 "hygienic safety range" identified by Swedish expert Dr. Bjorn Folkow). All studies of the health consequences of reducing dietary sodium fail to identify any population benefit for Americans; some find additional risk.

So, Andy, before you dust off that commentary for a third re-run, we suggest you change your focus and lament that this nutritional advice is not only unpalatable, it is likely unnecessary -- and join the Salt Institute in its call for a controlled trial of the health consequences of reducing dietary salt - or sodium.

"Sodium: the missing link" is timely advice for ulta-endurance Ironman competitors, but it contains useful information about the importance of sodium (salt) to a healthfully-functioning body. RaceAthlete.com has this advice:

Sweat rate, genetics, fitness level and acclimatization will affect the amount of sodium lost during a race. A well-conditioned, heat acclimatized athlete would lose about 920-1840 mg per liter of sweat per hour of racing. If you can get an idea of your personal sweat rates, a good place to start with Na supplementation would be in the middle of that range. For example, if the average sweat rate is = 1.5 liters per hour, about 1380 mg Na per liter = 2070 mg Na (about 2 grams) is lost per hour.

We are making assumptions since we can never really know how much sodium a person looses unless tested. For instance, another elite Australian Ironman triathlete went to the Gatorade Sports Institute to determine his Na needs. Through testing, they found he needed 3,000 mg per hour! This demonstrates the wide range of Na intake between individuals.

With hot summer weather here and still ahead, this advice could make your outdoor exercise enjoyable or even save your life.

The U.S. Food and Drug Administration is always between a rock and a hard place. Consumers want the latest and best drugs NOW and they want them thoroughly tested for safety and effectiveness, a process that takes years.

Seeking to introduce efficiencies into the process of conducting the trials to speed them up and lower costs that are passed along to consumers, FDA's deputy commissioner Scott Gottlieb has announced plans to develop guidelines for "adaptive trials." An "adaptive trial" would allow a very different model from the classic scientific testing where the hypothesis is clearly stated at the outset and "post-hoc" adjustments are greeted with great skepticism or rejected automatically. Only an ethical or safety issue would adjust, or more likely, terminate, a clinical trial under the current rules.

Nobody can be for long and costly trials, but "trials" are what they are: not the real thing. If we shortcut the careful and objective science, already compromised by hidden agendas of funding agencies or researchers out to bolster their credentials and their careers, we risk undermining the credibility of our regulatory watchdog. This will bear careful watching.

For example, if the new rules were to apply to non-pharmacolgic investigations as well as trials of new drugs, the reported conclusions of the massive, to-be-definitive Intersalt Study back in 1998 would have been far different. The primary hypothesis was stated that evidence would show that sodium excretion (salt intake) was directly related to population systolic blood pressure. The secondary hypothesis was that sodium excretion (salt intake) was directly related to population diastolic blood pressure. The evidence did NOT confirm these hypotheses, but the reseachers wanted to conclude that salt was problematic so they performed a cohort analysis and constructed a new hypothesis of "blood pressure rise with age" (also subsequently debunked).

Another example, the federal government conducted its Trials of Hypetension Prevention Part II and found that in the first six months, systolic blood pressure fell sharply by about 6-7 mmHg from 127.7 mmHg. It issued news releases and has continued to tout this result for years. But the trial was a 36-month trial and, although sodium intakes remained 920 milligrams below baseline after 36 months after initally declining by 1,150 mg, blood pressure regressed back to its high "normal" of 127.1 mmHg, a statistically insignificant change -- so insigificant that the government sponsors decided to ignore it and use only the 6 months figures which did find the "correct" change.

If the government cooks the books under the current, more rigorous rules, we need to put into place additional guidelines to restore the credibility of its analyses, not further erode the process and our confidence in its conclusions.

Cornell University researchers have discovered why gorillas eat rotting wood: for the salt. Remote areas often lack sufficient salt for their human and animal denizens and, recognizing that salt is an essential nutrient to survival, all species go to often-disgusting extremes to get the salt they need. The research will be published shortly by the Royal Society of Biology, according to a Fox News report July 10th.