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Tuesday, July 26, 2016

How salt shakes out

From what I know courtesy of friends and colleagues who work there, it's always busy at the Food and Drug Administration (FDA). Still, the agency seems to be in the midst of a particular flurry of activity. Even if the activity has not picked up, the profile of it certainly has. In quick succession of late, the FDA has made headlines for updating food labels, revisiting the definition of “healthy,” and now, shaking up the salty status quo.

Specifically, the FDA has issued “draft voluntary targets for reducing sodium in commercially processed and prepared food both in the short-term (2 year) and over the long-term (10 year).” We might constructively pause and reflect on the particulars of that phrasing. First, the current guidance is just a “draft,” and has been put on display to invite public commentary. Thus, nothing yet has been finalized.

Second, the targets, even once they become final and official, are “voluntary.” The FDA in this instance is talking about guidance, not regulation. Players in the food service space still get to decide if they want to play by these rules or not. There is no proposed penalty for opting out, other than the potential rebuke of customers. In effect, FDA guidelines give consumers a standard by which to judge industry practice.

And third, even once final and official, the voluntary targets are delayed and in phases. Nothing happens right away, and when something happens, it happens small. The targets thought suitable for public health don't really kick in for a decade.

All of this to say that objections to the FDA action, of which there are many, are phenomenally out of proportion to the action itself. I side with those celebrating the FDA's announcement, but frankly, the basis for celebration is slim. The basis for protest is slimmer still. There simply isn't any drama here.

As for why I side with the FDA, and not with the protesters, who happen to include some colleagues and even friends, it's all but self-evident with cursory attention to the real world. The FDA is attempting to fix what's broken; the protesters are fretting about a problem that not only doesn't exist, but is far from likely to exist. I'll expound, but first note that this is a position I have mapped out before, more than once, and more than twice.

Until fairly recently, the public health community would likely have been universal in its support of FDA's efforts to constrain the grains of salt populating processed food. While not everyone has agreed with the contention that excess sodium, resulting in high blood pressure, leading in turn to strokes, implicates sodium in 150,000 premature deaths in the U.S. each year, pretty much everyone was comfortable with the idea that we eat too much, and too much is generally bad for us in a variety of ways.

What happened recently is that some studies began to reveal the potential harms of too little sodium ingestion. The most notable paper on this topic was a review in the Lancet that garnered high-profile media attention.

The literature suggesting potential harms of overzealous sodium reduction has spawned a secondary literature warning against efforts to reduce sodium intake at all. In at least 1 case, the argument was made that attention to sodium would divert attention from sugar. With regard to that last one, I certainly differ. I think attention to any one nutrient at a time has diverted attention from the overall wholesomeness of foods, and the quality of the diet, and that's where the action really is. But that's no reason to ignore the relevant effects of any given nutrient for favor of another, but rather a mandate to address both, along with all the others, holistically.

In any event, there is now a large volume of noise arguing against sodium reduction, and many in that chorus are now protesting the FDA action. The Lancet paper is among those invoked to justify this position, but that pushes the envelope to the tearing point. Here is the conclusion the authors of that paper reached: “lowering sodium intake is best targeted at populations with hypertension who consume high sodium diets.”

Well, pretty much all Americans consume high-sodium diets. And, there are about70 million hypertensives in the United States now. That's a figure that bears repeating: 70 million.

But that's just now. A study recently told us that half the population of California is prediabetic. Why California? Not because the problem is worse there than elsewhere, but because the data are better. This is the situation throughout the U.S. There are many liabilities attached to prediabetes, and hypertension is frequently in that mix.

So, while “only” a third of adults in the U.S. are hypertensive now, we have portents of that rising to half. We also, by the way, have ever more prehypertension and hypertension, and prediabetes and diabetes, for that matter, in children.

OK, but since not EVERYONE is hypertensive, shouldn't sodium reduction efforts just be directed to the tens of millions who are? Maybe, except that doesn't work. Given the copious quantities of sodium in most commercially prepared food, experts have long concluded that the only effective strategy for meaningful sodium reduction is to change the food supply.

But won't the FDA efforts to do just that impose the risk of too little sodium on the other half of the population? Hardly. Leaving aside the improbability of an action catalogued as draft, voluntary, and delayed having the impact to hurt anyone, the crux of the matter here is dose.

While there has long been concern about the potential harms of too little sodium (no, it's not new), and rebuttal to that concern for just as long, that concern is most acute for sodium intake well below 2000 mg per day, and only begins at intake below 3000 mg per day. The average intake in the U.S. among adults is 3400mg per day. Stated differently, Americans would have to reduce mean sodium intake by about 12% before hitting even the top end of the range where even a small minority of researchers see even the start of any basis for concern.

For what it's worth, I find it highly implausible that harms would result from sodium reduction well below 3000 mg, and not because of clinical trials. Rather, we already know that many populations around the world, including some of the healthiest, routinely consume dramatically less sodium than we do, simply because they don't eat processed foods. We also know, from the best papers by the best experts, that our native, Paleolithic intake was even more dramatically lower than the current norm. The likelihood of being harmed by a sodium intake commensurate with our native adaptations would be hard to explain.

And lastly, there is always recourse to a salt shaker. Tepid as it is, the FDA statement says nothing at all about obligating anyone to reduce their sodium intake. Rather, this is an attempt to remove the virtual obligation we have now to over-consume sodium. In a world where commercially prepared food is routinely lower in salt than it is now, there is at least the chance of getting down to reasonable intake levels. Those concerned about getting too little on the basis of idle anxiety, or their medical status and physician advice, can shake it on as the spirit moves them.

That, then, is how this all shakes out for me. Sodium reduction to reasonable levels is uncontroversially good for those with hypertension, and that is already a third of U.S. adults, and rising. It is probably good for everyone else, too, since current intake is far above reasonable. The risks of too little sodium in the context of the horribly sorry, typical American diet are both theoretical, and rather far-fetched. The risks of too much are clear, and all but omnipresent.

You are no more obligated to wait for the FDA's draft, voluntary, and deferred guidance to kick in than you are to reduce your personal sodium intake if disinclined. Eat less processed, more wholesome foods right now — and fix your sodium intake by looking right past salt to the character of your diet. We have long had abundant evidence that people who do just that move from health risk, not into it.

Risks of too little sodium are a valid concern only at levels massively below mean intake in the U.S., while the harms of excess are with us right now. The priority, obviously, is fixing what's broken. Kudos to the FDA. Their action on salt does not yet have traction in the real world, but it does pertain to it.

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Blog log

Members of the American College of Physicians contribute posts from their own sites to ACP Internistand ACP Hospitalist. Contributors include:

Albert Fuchs, MD
Albert Fuchs, MD, FACP, graduated from the University of California, Los Angeles School of Medicine, where he also did his internal medicine training. Certified by the American Board of Internal Medicine, Dr. Fuchs spent three years as a full-time faculty member at UCLA School of Medicine before opening his private practice in Beverly Hills in 2000.

And Thus, It Begins
Amanda Xi, ACP Medical Student Member, is a first-year medical student at the OUWB School of Medicine, charter class of 2015, in Rochester, Mich., from which she which chronicles her journey through medical training from day 1 of medical school.

Auscultation
Ira S. Nash, MD, FACP, is the senior vice president and executive director of the North Shore-LIJ Medical Group, and a professor of Cardiology and Population Health at Hofstra North Shore-LIJ School of Medicine. He is Board Certified in Internal Medicine and Cardiovascular Diseases and was in the private practice of cardiology before joining the full-time faculty of Massachusetts General Hospital.

Zackary Berger
Zackary Berger, MD, ACP Member, is a primary care doctor and general internist in the Division of General Internal Medicine at Johns Hopkins. His research interests include doctor-patient communication, bioethics, and systematic reviews.

Controversies in Hospital Infection Prevention
Run by three ACP Fellows, this blog ponders vexing issues in infection prevention and control, inside and outside the hospital. Daniel J Diekema, MD, FACP, practices infectious diseases, clinical microbiology, and hospital epidemiology in Iowa City, Iowa, splitting time between seeing patients with infectious diseases, diagnosing infections in the microbiology laboratory, and trying to prevent infections in the hospital. Michael B. Edmond, MD, FACP, is a hospital epidemiologist in Iowa City, IA, with a focus on understanding why infections occur in the hospital and ways to prevent these infections, and sees patients in the inpatient and outpatient settings. Eli N. Perencevich, MD, ACP Member, is an infectious disease physician and epidemiologist in Iowa City, Iowa, who studies methods to halt the spread of resistant bacteria in our hospitals (including novel ways to get everyone to wash their hands).

db's Medical Rants
Robert M. Centor, MD, FACP, contributes short essays contemplating medicine and the health care system.

Suneel Dhand, MD, ACP Member
Suneel Dhand, MD, ACP Member, is a practicing physician in Massachusetts. He has published numerous articles in clinical medicine, covering a wide range of specialty areas including; pulmonology, cardiology, endocrinology, hematology, and infectious disease. He has also authored chapters in the prestigious "5-Minute Clinical Consult" medical textbook. His other clinical interests include quality improvement, hospital safety, hospital utilization, and the use of technology in health care.

DrDialogue
Juliet K. Mavromatis, MD, FACP, provides a conversation about health topics for patients and health professionals.

Dr. Mintz' Blog
Matthew Mintz, MD, FACP, has practiced internal medicine for more than a decade and is an Associate Professor of Medicine at an academic medical center on the East Coast. His time is split between teaching medical students and residents, and caring for patients.

Everything Health
Toni Brayer, MD, FACP, blogs about the rapid changes in science, medicine, health and healing in the 21st century.

FutureDocs
Vineet Arora, MD, FACP, is Associate Program Director for the Internal Medicine Residency and Assistant Dean of Scholarship & Discovery at the Pritzker School of Medicine for the University of Chicago. Her education and research focus is on resident duty hours, patient handoffs, medical professionalism, and quality of hospital care. She is also an academic hospitalist.

Glass Hospital
John H. Schumann, MD, FACP, provides transparency on the workings of medical practice and the complexities of hospital care, illuminates the emotional and cognitive aspects of caregiving and decision-making from the perspective of an active primary care physician, and offers behind-the-scenes portraits of hospital sanctums and the people who inhabit them.

Gut Check
Ryan Madanick, MD, ACP Member, is a gastroenterologist at the University of North Carolina School of Medicine, and the Program Director for the GI & Hepatology Fellowship Program. He specializes in diseases of the esophagus, with a strong interest in the diagnosis and treatment of patients who have difficult-to-manage esophageal problems such as refractory GERD, heartburn, and chest pain.

I'm dok
Mike Aref, MD, PhD, FACP, is an academic hospitalist with an interest in basic and clinical science and education, with interests in noninvasive monitoring and diagnostic testing using novel bedside imaging modalities, diagnostic reasoning, medical informatics, new medical education modalities, pre-code/code management, palliative care, patient-physician communication, quality improvement, and quantitative biomedical imaging.

Informatics Professor
William Hersh, MD, FACP, Professor and Chair, Department of Medical Informatics & Clinical Epidemiology, Oregon Health & Science University, posts his thoughts on various topics related to biomedical and health informatics.

David Katz, MD
David L. Katz, MD, MPH, FACP, is an internationally renowned authority on nutrition, weight management, and the prevention of chronic disease, and an internationally recognized leader in integrative medicine and patient-centered care.

Just Oncology
Richard Just, MD, ACP Member, has 36 years in clinical practice of hematology and medical oncology. His blog is a joint publication with Gregg Masters, MPH.

KevinMD
Kevin Pho, MD, ACP Member, offers one of the Web's definitive sites for influential health commentary.

MD Whistleblower
Michael Kirsch, MD, FACP, addresses the joys and challenges of medical practice, including controversies in the doctor-patient relationship, medical ethics and measuring medical quality. When he's not writing, he's performing colonoscopies.

Medical Lessons
Elaine Schattner, MD, FACP, shares her ideas on education, ethics in medicine, health care news and culture. Her views on medicine are informed by her past experiences in caring for patients, as a researcher in cancer immunology, and as a patient who's had breast cancer.

Mired in MedEd
Alexander M. Djuricich, MD, FACP, is the Associate Dean for Continuing Medical Education (CME), and a Program Director in Medicine-Pediatrics at the Indiana University School of Medicine in Indianapolis, where he blogs about medical education.

More Musings
Rob Lamberts, MD, ACP Member, a med-peds and general practice internist, returns with "volume 2" of his personal musings about medicine, life, armadillos and Sasquatch at More Musings (of a Distractible Kind).

Prescriptions
David M. Sack, MD, FACP, practices general gastroenterology at a small community hospital in Connecticut. His blog is a series of musings on medicine, medical care, the health care system and medical ethics, in no particular order.

Reflections of a Grady Doctor
Kimberly Manning, MD, FACP, reflects on the personal side of being a doctor in a community hospital in Atlanta.

The Blog of Paul Sufka
Paul Sufka, MD, ACP Member, is a board certified rheumatologist in St. Paul, Minn. He was a chief resident in internal medicine with the University of Minnesota and then completed his fellowship training in rheumatology in June 2011 at the University of Minnesota Department of Rheumatology. His interests include the use of technology in medicine.

Technology in (Medical) Education
Neil Mehta, MBBS, MS, FACP, is interested in use of technology in education, social media and networking, practice management and evidence-based medicine tools, personal information and knowledge management.

Peter A. Lipson, MD
Peter A. Lipson, MD, ACP Member, is a practicing internist and teaching physician in Southeast Michigan. The blog, which has been around in various forms since 2007, offers musings on the intersection of science, medicine, and culture.

Why is American Health Care So Expensive?
Janice Boughton, MD, FACP, practiced internal medicine for 20 years before adopting a career in hospital and primary care medicine as a locum tenens physician. She lives in Idaho when not traveling.

World's Best Site
Daniel Ginsberg, MD, FACP, is an internal medicine physician who has avidly applied computers to medicine since 1986, when he first wrote medically oriented computer programs. He is in practice in Tacoma, Washington.

Other blogs of note:

American Journal of Medicine
Also known as the Green Journal, the American Journal of Medicine publishes original clinical articles of interest to physicians in internal medicine and its subspecialities, both in academia and community-based practice.

Clinical Correlations
A collaborative medical blog started by Neil Shapiro, MD, ACP Member, associate program director at New York University Medical Center's internal medicine residency program. Faculty, residents and students contribute case studies, mystery quizzes, news, commentary and more.

Interact MD
Michael Benjamin, MD, ACP member, doesn't accept industry money so he can create an independent, clinician-reviewed space on the Internet for physicians to report and comment on the medical news of the day.

PLoS Blog
The Public Library of Science's open access materials include a blog.

White Coat Rants
One of the most popular anonymous blogs written by an emergency room physician.

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