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.
Monday, July 25, 2016
Imposing regulations without evidence
“Experts” consistently champion evidence based medicine. Policy wonks opine that we could greatly improve patient care if we more consistently followed the evidence. Evidence has become a major buzzword in health care.
Yet too often regulations impact physicians that have no evidence base. I have argued against the clinical skills exam for many years. Please read this Washington Post article about the exam, “$1,300 to take 1 test? Med students are fed up.“
How about the method of note writing that Centers for Medicare and Medicaid Services inspired? Does anyone believe that our notes have improved with the billing requirements?
Do these impositions follow evidence? No! A regulation body imposes something that has face validity to them, but not to us.
As children we often learn the famous saying “What is good for the goose is good for the gander.” If evidence is really important (and why else do we even consider performance measurement), then we should hold the same standard to these regulations. We should not have regulations that impact health care imposed without a strong evidence base.
But then the world does not always act rationally.
db is the nickname for Robert M. Centor, MD, FACP. db stands both for Dr. Bob and da boss. He is an academic general internist at the University of Alabama School of Medicine, and is the Regional Associate Dean for the Huntsville Regional Medical Campus of UASOM. He still makes inpatient rounds over 100 days each year. This post originally appeared at his blog, db's Medical Rants.
Friday, July 22, 2016
Medical statistics and the art of deception
“There are 3 kinds of lies: lies, damned lies, and statistics.”
There is much truth in this quotation of uncertain provenance. We see this phenomenon regularly in the medical profession. We see it in medical journals when statistics are presented in a manner that exaggerates the benefit of a treatment or a diagnostic test. Massaging numbers is raised to an art form by the pharmaceutical companies who will engage in numerical gymnastics to shine a favorable light on their product. It's massaging, not outright mendacity. The promotional material that pharmaceutical representatives present to doctors is riddled with soft deception.
A favorite from their bag of tricks is to rely upon relative value rather than absolute value. Here's how this works in this hypothetical example.
A drug named Profitsoar is tested to determine if it can reduce the risk of a heart attack. Two thousand patients are participating in the study. Each patients receives either Profitsoar or a placebo at random. Here are the results. Of 1,000 Profitsoar patients, 4 had heart attacks. Of 1,000 placebo patients, 6 had heart attacks.
As is evident, only 2 patients were spared a heart attack by the drug. This is a trivial benefit, as only 6 of 1,000 patients in the placebo group suffered a heart attack. This means that taking the drug provides no meaningful protection for an individual patient. However, the drug companies will highlight the results in relative terms to package the results differently. They will claim that Profitsoar reduced heart attack rates by 33%, which would lure many patients and a few doctors to drink the Kool Aid.
Check out this promotional piece below which was recently mailed to me about Uceris, a steroid that I use at times for colitis patients.
See how low the actual remission rates are for the drug. Only 18% of patients responded to the drug, a small minority, and the placebo rate was 6%. No worries. Just brag that Uceris is 3 times more effective than placebo!
Is this a lie? Not exactly. Is it the truth? Technically yes.
Most physicians are tuned into this deception. I know from my own patients that the public is easily seduced by this slick presentation of data. The next time you see a TV ad for a medication, which will be about 5 minutes after you turn on the TV, see if you can spot the illusion. You'll have to watch quickly and repeatedly. Like all skilled magicians, these guys are expert at distraction and sleight of hand. Hint: Whenever you hear the word “percent,” as in “35% of patients responded …,” you should pay particular attention.
When we used to see a woman sawed in half on stage, we knew it was a trick even if we couldn't explain how it was done. I've taken you behind the curtain here. Let's make it a fair fight between us and illusionists.
This post by Michael Kirsch, MD, FACP, appeared at MD Whistleblower. Dr. Kirsch is a full time practicing physician and writer who 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.
Thursday, July 21, 2016
Freedom versus control in a private vs. public health care system
This is my 12th year as a physician in the United States. I was born in London, grew up in Berkshire, and decided to become a doctor when I was a teenager. I remember being asked what I thought about the National Health Service (or NHS, the UK's government-run health system) during my medical school interview. That question is almost a rite of passage for anyone applying to medical school in the UK. My answer was an idealistic one, probably identical to what most people in England—if not Europe—would say. Health care is a birthright.
The NHS is a wonderful concept and immensely fair and just. Nobody should ever have to pay for medical care in their hour of need, right? I speak too as someone of Indian heritage, who has seen up close and personal how unexpected illnesses in relatives can completely bankrupt families, causing untold anxiety and stress. Surely nothing could be worse than that free-market extreme with no public system backup?
During medical school, I also worked for a couple of months in Adelaide, Australia, primarily in Accident & Emergency/Trauma in a major tertiary care center. I also did a stint with the Royal Flying Doctor Service going on airborne missions to the outback, mainly rescuing very sick indigenous (Aboriginal) people and bringing them back to the city. The system Down Under is an interesting mix of both public and private health care, but still with a solid government-run backbone for people who really can't afford insurance. However, at that time, even the thought of having to pay for health care at all still seemed very foreign to me as I began my career as a physician.
Before I came to the U.S. back in 2005 to start my medical residency, these were my views on the funding of health care. Fast forward to 2016, and my opinions have shifted rather dramatically in terms of what a health care system should look like and whether people should contribute more themselves. Looking back to when I first moved here, one of the things that first struck me about U.S. medical care was the sheer speed and freedom of it all. Patients appeared free to choose their physicians, were in more control over their care, and didn't have to wait so long to get things done. My jaw dropped when one of my first patients was admitted from the ER, and had already had most of their tests and scans done, including an MRI. They would then be seen by all of the doctors they needed to, including any necessary specialists, within a very short period of their hospitalization. These attending physicians would follow-up with them daily (unlike in the UK, where the vast bulk of the work is left to more junior doctors).
We can get into a debate about fee-for-service and incentives, but it's human nature that people and organizations work harder when they are incentivized to do so. Documentation was also much more thorough than the couple of lines that I was used to seeing scribbled in a patient's chart (True, a lot of this was for billing purposes, but it's still always good to be thorough). Since my very first week working as a medical resident, I've said, and continue to say, that a homeless person presenting with an acute illness such as sepsis or a myocardial infarction in America, will get better and more outstanding care than a rich person almost anywhere else in the world. There's a very common misconception overseas that patients in America are left dying on roads outside the hospital if they cannot afford care! This simply isn't true, and I learned it very fast. Clinical care in the United States is top-notch (albeit at a high cost). As are the central issues of patient dignity, patient rights, and accountability of any hospital or clinic to seriously address any complaints.
Physicians too in America, appeared to have a much better deal than in the system I'd just come from. They were more in control of where and how they worked, weren't restricted in terms of their career progression by the government, and were also compensated a great much more for their hard work (granted however, they also had a much higher debt burden). Despite the problems and changes in U.S. health care over the last decade, it remains the case that doctors here have an unprecedented amount of freedom in how and on what terms they work, compared to almost any other country.
Having all these different experiences over the years, if you were to ask me today, I don't believe such a centrally controlled system like the NHS is an ideal system to aspire to. It restricts patients and physicians alike. It is too much at the whim of transient politicians, with no medical knowledge, who can enforce a universal country-wide policy change almost overnight (such as a change in patient rights, physician scheduling, or even banning all doctors from wearing white coats and ties, which is what happened in the UK). Neither does a centralized system foster the best environment for innovation or individualized care. Go to any patient floor in a socialized system, and it often has a Soviet-style aura about it, with rows of patients lined up, little personal space, monolithic designs, and staff wearing the same uniform. The collective American psyche is very different from Europeans, and the consumer-driven mentality here probably wouldn't endear itself to an NHS-type system anyway.
With regards to funding, I don't think it's necessarily a bad thing for patients to contribute themselves for doctor visits and hospital stays, as long it is capped at a very manageable level for the individual, with absolutely no “surprise bills”. There's an argument to be made that if people in England are so willing to spend £30 ($50) for regular restaurant visits, haircuts and other entertainment—why not a small co-pay for a doctor visit? Anything that's completely free can easily foster an increasing culture of entitlement, reduced self-responsibility, and sadly sometimes abuse of the system.
At the other end of the spectrum, is the idea of caring for peoples' health from cradle to grave a noble one? Yes, it is. Should anyone be refused coverage because of a pre-existing condition or go bankrupt and lose sleep because of unforeseen medical bills? No, they shouldn't in any civilized country. Do many of the socialized healthcare systems produce better outcomes than us? Yes, they do. Is the high-cost system we currently have sustainable over the long term? No, it isn't.
Perhaps something in-between the two extremes would be best, like Australia, which gives tax breaks for people who take out private insurance, but still offers a public system as backup to anyone who needs it?
For this debate at least, I'm stuck between a rock and a you-know-what.
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. This post originally appeared at his blog.
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- How salt shakes out
- Imposing regulations without evidence
- Medical statistics and the art of deception
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- The argument for time based billing
- Naturopaths (unfortunately) just took a small step...
- Can we talk about mental illness?
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Members of the American College of Physicians contribute posts from their own sites to ACP Internistand ACP Hospitalist. Contributors include:
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.
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, 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
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.
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.
Toni Brayer, MD, FACP, blogs about the rapid changes in science, medicine, health and healing in the 21st century.
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.
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.
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.
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.
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.
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.
Kevin Pho, MD, ACP Member, offers one of the Web's definitive sites for influential health commentary.
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.
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.
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).
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
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)
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,
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
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.
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.
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.
The Public Library of Science's open access materials include a blog.
One of the most popular anonymous blogs written by an emergency room physician.