Thursday, January 28, 2016

'Freakish'

“I remember,” she said, “the day when it crossed into something else. Into that freakish range where mothers hiss to their kids to stop staring. At first you think that, just maybe, it's an accident. Then you realize that it isn't. They're whispering and pointing at you.”

I squinted my eyes and tried to imagine it. My patient, minding her own business and moving slowly through the aisles of a store. Maybe even doing something like picking up lightbulbs and hand towels in the home improvement section at Target. People walking by and doing those not-so-subtle double takes and her trying her best to not notice it. But she was right. This was more than just a little out of the range of normal. And though I wouldn't choose a word like “freakish” to describe it, I'd be lying if I said that it didn't somewhat fit the definition of that word. Even if it sounds mean to think that way.

Sigh.

Patients like her require special provisions. They bring in a special bed aptly or rather, horribly, referred to as a “big boy bed” to accommodate such a large body. It's hard not to hitch your breath and stare for a beat when you first see her and others of her body habitus. Legs easily larger than my husband's torso and a midsection that appears far too heavy to be supported even by those extremities. The adult in you tries not to see the large pannus lying flaccid over their thighs and fights those silly juvenile thoughts like, “What happens when it's time to go to the bathroom?” or, I'm even more embarrassed to admit, “How would she or he make love? “ I timidly raise my hand and admit that I do have these fleeting thoughts. The adult in me flicks them away. But every time, they appear and require that flick.

Yeah.

This encounter with me certainly wasn't helping her self-image. My patient had some shortness of breath and was, literally, too big to receive any of the diagnostic studies that we'd considered. She could not have a CT scan. Her circumference exceeded that of the scanner and her weight was more than 150 pounds beyond the limit of the table. A stress test or even an echocardiogram would be so limited in accuracy that it was almost deemed futile and a waste of her money and time to pursue. And to make matters worse, even if a stress test did find even some equivocal result, the cardiac catheterization lab wouldn't be able to handle 650 pounds on their support structure either.

Nope.

Ever since I was a resident physician in Cleveland, Ohio back in the 1990's, this kind of issue has periodically come up. Without fail, no matter where you practice, some well-meaning person speaks of the urban legend of the city zoo being an option. And no, not with cackling mean-person sarcasm but with a full-on, dead serious expression. A medical student looks stunned and queries whether or not a patient can truly go to the zoo for such a thing at which point whomever is speaking affirms it as the gospel. All of it reminds me of those stories of funny names in newborn nurseries, like the woman who named her twins “Oranjello” and “Lemonjello” since that's what they fed her in labor and delivery before she had them. Somehow the mother of those twins has managed to live in Cleveland, Ohio; Nashville, Tennessee; and Atlanta, Georgia. That, or she doesn't exist.

The zoo thing, though, I must admit always intrigued me. So, a few years after I came to Atlanta, I called Zoo Atlanta on behalf of a patient of mine. He needed a cardiac catheterization and I wanted to actually sniff out this trail to see if it truly would lead somewhere. Several of my calls were met with chuckles. Even when I reached some nice tech in the Large Animal area, he notified me that the zoo veterinarians did have X-ray machines and even a cath lab made special for elephants and such, but that actually having human cardiologists come in to use them on humans wasn't something he was aware they did. After that I spoke to our cardiologists who calmly answered me (while staring incredulously) telling me that logistically, it would be too much.

“We couldn't really do interventions either, Kim.”

“Like place a stent or something?”

“Yes. And even if there was something significant enough for bypass, that wouldn't be an option either. The anesthesia risk would just be too great,” the cardiologist said.

“I appreciate you actually thinking this through,” I recall mumbling.

“This is really a sad, Catch-22 of a situation. I hate when it comes up.”

And that was just sort of where we left that. But some piece of me has always felt this weird mixture of better because I actually checked before and discouraged for the very same reason.

Yeah.

So the truth is that, there wasn't anything I could do other than talk to her and listen to her story. And since she'd navigated the last several years of her life as what some would deem a “freak” I just made up my mind to humanize her the best I could.

I noticed her light brown eyes that almost appeared amber, framed with sprawling black eyelashes. She had a dimple in her chin that I thought was cute, whether she was smiling or not. The right cheek had a beauty mark on it, the kind that many women wished for but she'd obviously been blessed with at birth. And her teeth were unusually straight, large and strong appearing. Even though she didn't smile so much.

And so. I listened to her story of the transition from “always a chunky kid” to “overweight” to “really obese” to “freakish.” I didn't rush her either. I just sat and paid attention and focused on her lovely eyes, her beauty mark and that cleft in her chin wondering what I could possibly do.

“Those surgeries scare me,” she finally said.

“Surgery is a big deal,” I replied.

“Yeah. I just feel like it would be such a failure to get an operation just because you couldn't stop eating.”

I twisted my mouth and paused before speaking. “Food relationships are complicated. I think of weight loss surgery as an option that is now available that wasn't before, you know? But yeah, surgery isn't something to treat lightly.”

“My relationship with food has never been healthy.”

“I understand.” I wondered if I should say the next thing in my head, but then decided not to overthink it. “I say just look into it. Make a decision after you look into it, you know?”

“Guess I'd not have much to lose, right?” After she said that we both chuckled at the unintended pun.

“Um … you could also look into … okay, have you ever heard of this organization called ‘Overeaters Anonymous?‘” I inwardly cringed when saying the name of it but felt she should consider it. I hoped she wasn't offended. But she shook her head and looked intrigued.

I told her about this 12-step organization that tackled food relationships much like other tried and true organizations helped patients deal with substance abuse issues. And we looked at the website right then and there on our cell phones and she promised me she'd check it out.

And that was that.

We discharged her a few hours after that. Honestly, there wasn't really any more tests I could order and, fortunately, she was doing well enough where most weren't indicated anyway after all was said and done. But I have found myself thinking of her. Pondering her world and that threshold of going from overweight into, to use her words, “freakish.” And usually it just leaves me feeling kind of sad.

That is, until this morning when I allowed myself to reflect on what I remember the most about her. Her smile, her enviously stunning eyes, that beauty mark that Marilyn Monroe had nothing on, the tiny indentation in her chin and especially her fearless transparency in describing her life. I realized that this is what I see in my mind when I think of her. And I see that part in greater clarity than anything else.

And that? That leaves me feeling hopeful that at some point something will happen that allows the entire world to see that, too.

Yeah.

Kimberly Manning, MD, FACP, FAAP is an associate professor of medicine at Emory University School of Medicine in Atlanta, Georgia where she teaches medical students and residents at Grady Hospital. This post is adapted from Reflections of a Grady Doctor, Dr. Manning’s blog about teaching, learning, caring and growing in medicine and life. It has been adapted and reprinted with permission. Identifying information has been changed to protect individuals’ privacy.
Wednesday, January 27, 2016

Was granny sent home from the hospital too soon?

Over the years, I have heard families bemoan that their relative who was just readmitted to the hospital was sent home too early just a few days ago. Are they right?

First, let me say that in some instances they may be correct. It is certainly possible that the hospital, under increased pressure to kick folks out, may have pulled the discharge trigger too soon. The hospital is not always right even if their discharge check list seemed to be in order. Of course, patients are not adequately represented by a check list any more than physicians' quality can be fairly measured in the check-off, cook-book method that the government and insurance companies are now championing.

The hospital discharge check list may indicate that a patient with pneumonia can be safely discharged home as she has no fever or need for supplemental oxygen. However, this patient may be 89 years old, riddled with arthritis and needs to attend to a spouse suffering from Alzheimer's disease. Is she really ready for home life?

Hospitals these days are more careful than ever about premature discharge, not so much from newfound compassion, but because they will suffer a financial penalty if a patient is readmitted within 30 days under certain circumstances. For example, if a patient with congestive heart failure is sent home, but then returns 2 weeks later with worsening heart failure, then the hospital will lose money. This has created a robust outpatient follow-up industry with visiting nurses, physicians and social workers to try to keep folks from coming back to the hospital, at least within 30 days. (Joke alert: The terminal phrase of the last sentence was in jest.) I applaud this system which serves everyone's interests.

In the hospital, care coordinators cruise through the corridors leafing through charts to initiate discharge planning. These are nurses who have left the wards for a cleaner administrative function. Although I did disparage the hospital discharge check list mentality above, and rightly so, I have found these care coordinators to be compassionate and understanding with regard to individual patient circumstances. They know when to bend some rules, perhaps because they were once hands on nurses themselves.

Sometimes, a patient needs to be readmitted to the hospital and it's simply no one's fault. It is a difficult concept for many Americans to grasp that an adverse event could occur without an individual or an institution to blame. Remember, we live in a society where folks sued Burger King alleging the company was responsible for their kids' obesity.

I counsel families that when we are sending their relative home, particularly when they suffer from chronic diseases or other incurable conditions, that we do so based on what I and the others on the team know at the time. We are not clairvoyant. If we had this power and knew that the patient would become more ill 3 days hence, we wouldn't sent him home. It's may not be quite fair, but would be quite understandable, to wonder if a patient who is readmitted should never have been discharged home in the first place. There are some patients who are so fragile, that they can tilt backwards anytime and for very small reasons.

What we know for sure is that life and illness are unpredictable.

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.
Tuesday, January 26, 2016

DNA is not destiny? Well, duh

A high profile paper just published in the highly prestigious journal Nature suggests that overwhelmingly, cancer results from “extrinsic factors,” namely behaviors and exposures, rather than the “intrinsic” transgressions of our chromosomes. The media response is a proclamation that no, cancer is not just about “bad luck.” So august a platform for so salient a proposition seems to demand a highly erudite response, and I've got just the one: duh.

Didn't we know this already?

Yes, it's true, that almost exactly a year ago, a paper was published in the only journal that competes with Nature for prestige, Science, attributing cancer risk to the frequency of stem cell divisions, and propagating a spate of media coverage about the randomness of cancer. But the fallacy in that reporting is a long-established fact of epidemiology: Cancer rates vary substantially with lifestyle and environments. While variation in stem cell divisions might say something about the aggregation of mutations in any given tissue, we have long had cause to know it does not meaningfully account for differential cancer risk among people, or populations.

The novelty of the new paper is not the emphasis on environmental and behavioral explanations for many cases of cancer. One might call that yesterday's news, but in reality, it was yesterday's news long before yesterday; it was yesterday's news in 1982. Sir Richard Doll and Richard Peto published a famous paper in the Journal of the National Cancer Institute in 1981 characterizing the substantial preventability of cancer. A recent reassessment of their estimates concluded they appear to be valid after 35 years of scrutiny. And, of course, when McGinnis and Foege told us in 1993 that premature deaths in the United States were overwhelmingly preventable, again by modifying behaviors and exposures, cancer deaths were certainly in that mix.

The novelty in the new paper in Nature was to apply what we have long known about the salience of “extrinsic” causes of cancer directly to the proposition about “intrinsic” causes in the prior Science paper. What the current group concluded is that more frequent stem cell divisions does, indeed, create more opportunity for carcinogenic mutations- but that external factors provoke those mutations. Nature, in other words, has come down on the side of nurture.

In this epigenetic age, there is an expression that captures this interplay: Genes load the gun, but lifestyle pulls the trigger.

Even more bluntly: DNA is not destiny. There are exceptions, of course. If you are dealt two copies of the sickle cell anemia gene, you develop sickle cell anemia inevitably. The same is true with just one copy of the gene for Huntington's disease. Such exceptions are rare enough, however, to reaffirm rather than refute the basic proposition: generally, DNA is not destiny.

To a large, and largely neglected degree, dinner is. Or could be.

Of course, the alliteration is nice, but it's not really just “dinner.” It's breakfast, too. It's our overall dietary pattern. And it's not just diet either. It's our lifestyle.

Lifestyle, in turn, is accountable to and dependent on social and environmental factors. Even causes have causes. The choices we make are ultimately subordinate to the choices we have. Some whole cultures serve up choices that foster health. Some do rather the contrary.

Still, we might constructively collate these insights. Whether by virtue of behaviors chosen and practiced by individual bodies, or by exposures, environments, and policies referable to the body politic, the underlying causes of cancer, as for other major chronic diseases, are overwhelmingly preventable. The new paper posits the arrestingly high figure of up to 90% so. Whether it is that, or the more modest 60% that has long been touted by those in the know, it is a luminous and tantalizing proposition just the same.

Even as we concede that the daily choices we make as individuals are to varying degrees subordinate to the choices we have by virtue of our culture, we might acknowledge one choice we could make any time. We could choose to stop rediscovering what we already know.

We have long known that lifestyle practices, whether born of personal choice, or public action, could eliminate the majority of cancers, and an even higher majority of other chronic diseases. We have long known how to prevent some 80% of premature deaths.

But as long as we remain interested in rediscovering what we know rather than putting it to good use, knowledge isn't power. And while DNA isn't destiny, at present, neither is dinner, at least not the favorable destiny it might be. Rather, our destiny seems much consigned to our collective, cultural dysfunction.

We are ill-served by headlines that made cancer random a year ago and overwhelmingly preventable this year. Both studies in both prestigious journals contributed something to our basic understanding, but neither changed our options or the prevailing view from altitude. We don't know how to prevent every case of cancer, certainly, but cancer, along with every other major chronic disease, occurs far less often in populations that eat well, don't smoke, and stay active. The numerous centenarians in the Blue Zones are obviously not just not dying of heart attacks at age 70 or 80. Living to 100 means they are also not dying of anything else then either, cancer included.

A new year dawns, and with it, the alluring promise of new knowledge. We may hope that some of that knowledge will pertain to advances in the prevention and effective treatment of cancers, particularly those that defy our best efforts, and those that do seem truly random. But perhaps one of its greatest prospects for us all resides with the opportunity to renounce the need to rediscover next year what we knew and failed to apply last.

May this, then, be the year the wishful proposition about knowledge and power comes true. May it be the year we come together to lay hold of the master levers of medical destiny that have long been in our hands, and heave together. May this be the year we stop rediscovering what we already know, and actually, finally, do something with it.

David L. Katz, MD, FACP, MPH, FACPM, 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. He is a board certified specialist in both Internal Medicine, and Preventive Medicine/Public Health, and Associate Professor (adjunct) in Public Health Practice at the Yale University School of Medicine. He is the Director and founder (1998) of Yale University's Prevention Research Center; Director and founder of the Integrative Medicine Center at Griffin Hospital (2000) in Derby, Conn.; founder and president of the non-profit Turn the Tide Foundation; and formerly the Director of Medical Studies in Public Health at the Yale School of Medicine for eight years. This post originally appeared on his blog at The Huffington Post.
Monday, January 25, 2016

An organization for improving health care IT

On this blog, I've written about many subjects pertinent to the practice of medicine. This has always been from my perspective as a frontline physician, focusing on some of the challenges we see every day in hospital care. There is however one topic that I've written about more than any other, and it's one that is of particular interest to me: our interaction with health care information technology. Simply put, it is one of the biggest issues facing frontline health care at the moment—and for a number of reasons.

A massive change we've witnessed over the last several years has been the proliferation of technology at the frontlines of medicine. This is due in no small part to Meaningful Use, which is the federal government's financial incentive program to make hospitals and clinics across the United States fully computerized. And while I don't doubt that there may have been some noble intentions behind the push to make health care more technologically advanced, the way the process has unfolded, and the current IT solutions that exist are largely suboptimal, inefficient and cumbersome.

Ask any frontline physician (or nurse), and they will list health care IT as one of their biggest daily frustrations, as we are having to spend increasing amounts of our day navigating these systems. Even the simplest of tasks, such as ordering a Tylenol, simply takes too long to accomplish in what is supposed to be the faster world of information technology. Studies back up these concerns too, with research suggesting that physicians are now spending as little as 10% of their day in direct patient care. A statistic that is, quite frankly, a little sick.

So rather than just keep writing about the problem, I decided to actually do something more substantive. I founded HealthITImprove.com (HITI), an organization dedicated to working towards better and more efficient health care IT at the frontlines of medicine. We are guided by our core principles:

Health care IT represents the future of medicine but must be reconciled with frontline clinical workflow

Physicians (and nurses) should spend as much time as possible in direct patient care

Health care IT solutions should be designed to enable physicians to spend maximum time with patients

Health care IT should be discouraged from being used when talking to patients, because the core of good bedside medicine is direct eye contact and good face-to-face communication

All health care IT should be designed to be efficient, seamless and user-friendly

Are you a doctor, nurse or even a patient who agrees with our values and mission? Then visit www.HealthITImprove.com today and join us in our campaign to make health care IT better.

Follow us on Twitter:

https://twitter.com/HealthITImprove

Follow us on Facebook:

https://www.facebook.com/Health-Information-Technology-Improvement-1612311329034603/?ref=hl

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.
Friday, January 22, 2016

On becoming a better educator

Readers are slowly learning about my admiration for the Farnam Street Blog. The “about” page describes the blog in this way: My goal is to help you go to bed each night smarter than when you woke up. I'll do this by giving you tools, ideas, and frameworks for thinking. I'm not smart enough to figure all of this out myself. I try to master the best of what other people have already figured out. Sounds simple, doesn't it? The best way to do this is to read a lot. And so I make friends with the eminent dead. Along the way I write about what I'm learning. I'd encourage you to look around and decide for yourself if this is something that interests you.

Last week he reviewed The Laws of Simplicity by John Maeda. I read the book, and loved the approach to knowledge. As an educator, he has evolved to a BRAINy approach:

BASICS are the beginning.

REPEAT yourself often.

AVOID creating desperation.

INSPIRE with examples.

NEVER forget to repeat yourself.

I love this conceptualization. These lines seem counterintuitive to newly minted educators, but over time many evolve to understanding the wisdom in these lines.

As I work with medical students, interns and residents, these words accurately describe my evolution as an educator. We should never assume that our learners really understand the basics. Unfortunately (in my opinion) the first 2 years of medical school which should emphasize the basics, quickly get too complicated. We have not defined the basic, must know physiology, biochemistry, anatomy, pharmacology, histology and microbiology. Rather we try to teach the basics as well as the more advanced concepts all in one package. This style of teaching makes it more difficult for our learners to separate the important signals from the noise. The national testing (STEP 1) drives how we teach because of the way they test.

So too often our clinical learners do not really understand the basics. We who teach in the clinical years, therefore, must always start with the basics, and not assume that our learners “own” those basics.

Too many educators assume that when they brilliantly explain something that the learners will absorb that teaching. Unfortunately, cognitive psychology teaches us that learning often does not occur at the first exposure to a concept or fact. Try teaching something and asking questions about that teaching a week later. Neuroscience research teaches that we will help our learners actually learn the material when we repeat our teaching. As educators we then must teach the same concepts repeatedly. I have had 3rd year residents who rounded with me as 3rd year students, 4th year, interns and 2nd year residents. When I give the same short talk at morning report about a subject, they tell me afterwards that they have learned new things. Repetition actually works.

As medical educators we must acknowledge the difficulty of learning our field. Internal medicine is difficult. When we acknowledge that and encourage our learners that the road towards excellence is a long road, we decrease their anxiety and therefore increase their ability to concentrate and learn.

Examples in medicine are patient stories. Our teaching always improves when we focus on patient stories. When a point needs emphasis, tell a patient story about success or failure.

Finally, never fear repetition. It may seem that you are boring the learners, but believe me you are not. The learners appreciate your efforts to make certain that they are learning. Separate the concept of teaching from learning. Our job is not to teach but rather to induce learning. Teaching is meaningless if it does not result in learning.

And when in doubt repeat yourself.

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.
Thursday, January 21, 2016

The real reason infectious disease docs are the lowest paid physicians

In keeping with our annual tradition, Dan recently posted on the declining interest in ID fellowship slots filled through the match. Re-reading his 2013 and 2014 posts, it's quite clear things have not improved. It's also clear that IDSA takes the decline very seriously. In fact, 2 IDSA presidents, Dr. Stephen Calderwood and Dr. Johan Bakken, have taken time to post IDSA's diagnosis and responses to the public health problem. Both described the relatively poor compensation provided for ID services.

Quoting Dr. Bakken: ”There is no question in my mind that the financial student loan burden and inadequate reimbursement for ID services are major disincentives for young physicians contemplating a career in ID. IDSA alone does not have the power or means to rectify the problem, but we are working very hard with legislators and policy makers on Capitol Hill.”

Without getting too much into the weeds, I wanted to share with you why I think Infectious Diseases is so poorly reimbursed compared to every other subspecialty. The reason is as old as politics. We have no representation on the AMA's Relative Value Scale Update Committee (RUC). Since 1991, CMS has collected advice from this AMA Committee on how much “physician work” is involved in delivering a particular service. This committee is important, since CMS agrees with the committee's recommendations almost90% of the time. There is unequal and unfair representation on this committee. Some specialties are under-represented based on the number of services they provide (i.e. primary care) and certain medical subspecialties (e.g. nephrology, hematology) are only represented on a rotating basis while others (e.g. cardiology) have a permanent seat. Looking closely at the list of subspecialties, I don't see any Infectious Diseases representation!

So, if we want to fix ID, we need permanent representation on this committee. It is a complete travesty that the highly reimbursed procedure-focused subspecialties are fully represented but the “cognitive” subspecialties (endocrinology, ID, rheumatology) are invisible. IDSA needs to demand equal and fair representation.

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). This post originally appeared at the blog Controversies in Hospital Infection Prevention.

Letting the dumpster fire burn on and on

Over the past few weeks, we've seen a flurry of activity on the blog surrounding the decline of interest in the specialty of infectious diseases, as judged by the ever worsening Match results with fewer physicians entering the field. My post on IDSA's response (or lack thereof) generated a number of postings from IDSA officers. I appreciate their comments and have thought about them carefully. In the end, I'm sorry to say that I remain unconvinced that IDSA has a handle on either the problem or the solutions. I guess we'll know in a year when the next Match results are released.

In a nutshell, I think the present inability to recruit resident physicians into infectious diseases is due to loss aversion. We humans seem to be hard wired to avoid loss. Losses have been shown to be twice as powerful as gains in decision making. Thus, the resident weighing their career options gets fixated on the fact that 2-3 additional years of training will result in a significant loss of income likely over their entire career. All of this is magnified by educational debt. And to add insult to injury, choosing infectious diseases over hospital medicine will also mean longer hours and less control over their work schedule. Thus, the disparities in income and lifestyle between the 2 options are impossible for most to overcome, even when ID may be seen as more interesting, satisfying, and intellectually challenging. Putting myself into the shoes of an internal medicine resident, I have to admit that I probably would have chosen the hospitalist path but for the fact that it didn't exist in 1989.

Much of what IDSA is focused on (e.g., generating more interest in the field), while noble, doesn't address the core problem. Most worrisome is the fatalism in the comments made on Eli's Perencevich's post regarding compensation. The message in essence was: RVUs are low for cognitive specialties; that's just the way it is, get over it. The hospitalists, who are victims of the same E&M coding/RVU system have been much more creative. They have convinced hospital administrators to subsidize their operations. Moreover, in most compensation models, full time clinical activity means just that (full time clinical activity), with perhaps some reduction given for scholarly activity for those in academic settings. But the hospitalists have redefined math. For them 0.5 = 1.0; that is, full time clinical activity for a hospitalist means working every other week. And at a fair wage, I might add.

Economically punishing individuals who undertake more training to become specialists is and will continue to be a losing proposition for ID. From a results-oriented perspective, IDSA's approach isn't working. Solutions will need to be out-of-the-box game changers not incremental baby steps. As the field of infectious diseases continues to die a slow death, I fear IDSA's response will be the same as it ever was: too little, too late.

Michael B. Edmond, MD, FACP, is a hospital epidemiologist in Iowa City, IA, with a focus on improving the quality and safety of health care, and sees patients in the inpatient and outpatient settings. This post originally appeared at the blog Controversies in Hospital Infection Prevention.
Wednesday, January 20, 2016

No vaccination, no camp. Finally

In 2013, Emily Stillman developed a headache. Within hours she was dead. Emily died from one of the dozens of diseases that medical science has managed to control through vaccination. Unfortunately, she had not been vaccinated against the type of meningitis that took her. Despite the existence of a safe and effective vaccine, type B meningococcal meningitis was not seen as enough of a threat for mass vaccination in the U.S.

Thanks to efforts led by her mother Alicia, the meningitis B vaccine is now available in the U.S. to protect our children from Emily's fate.

Vaccination is a type of immunotherapy. For over 100 years, people have had their immune systems trained to defend against diseases that in the past caused great suffering and millions upon millions of deaths.

The concept is fairly simple: expose a person's immune system to an important part of a germ, and the immune system develops a “memory” for the germ. When you encounter, say, measles after having been vaccinated, your immune system's memory cells start to divide quickly and crank out antibodies to defend against the disease.

Smallpox was the first global killer eliminated completely as a human disease. Polio is getting close. All of this is due to exceptional public health efforts centered around vaccination.

There has been a seemingly-bizarre backlash against vaccination over the last decade led by people living mostly in affluent communities. There are a ton of great books on this phenomenon, especially Seth Mnookin's The Panic Virus, and Paul Offit's Deadly Choices.

Leaving aside the details, about which much has been written, the medical and public health communities are unanimous in support of childhood vaccination. Of course there are always individual doctors who go against what science has shown us. One of them lives and practices near me.

Dr. David Brownstein is a family doctor whose “goal is to inform the world about the power of holistic health solutions,” whatever that might mean. Yesterday he posted a dangerous and poorly-informed piece on his website. First a bit of cultural background.

Dr. Brownstein practices in the heart of Michigan's Jewish community. Among American Jews, summer camping has been an important part of childhood for nearly a century. In the early part of the 20th century, it was felt that city children would benefit greatly from exposure to nature. Jews were not allowed to attend most camps and started their own. The tradition has remained strong.

I spend a week every summer helping to keep an eye on the kids at 1 such camp. During the flu epidemic of 2008–09, I watched as dozens of kids came down with a new flu strain, 1 for which a shot had not yet been developed. It was a frightening lesson in what can happen in unvaccinated populations. Thankfully, the strain wasn't deadly in this population. Among the hardest hit were pregnant women.

Still, it did put a damper on the summer for many kids. Last winter, another in which we had a flu strain not well-covered by the vaccine, I lost nearly half a dozen patients. All were elderly, and really didn't stand much of a chance. But if the people around them had been immune they might have lived through the winter never knowing what might have happened.

My daughter, who attends the same camp as I did, has had every shot, always on schedule. Thankfully so have her friends. I'd be very hesitant to let her play with kids who weren't vaccinated, both because of the small but real risk she could catch something, and because I would not want her to give an illness to someone else.

One of our largest summer camps here reportedly sent out a letter this week informing the community that all staff and campers must be fully immunized to attend camp next summer. This is great news for our kids.

But Dr. Brownstein doesn't think so. His blog lists the usual arguments against requiring vaccination, all of which are, to be blunt, total bullshit. It's not even good bullshit, but bullshit that has long been known to be, well, bullshit.

For those of you who want the detail, read on. If you don't, feel free to skip to the final paragraph for a summary. So let's go through Brownstein's arguments point-by-point:

“You might assume that Tamarack Camps, which has been around for over 100 years, must have had an outbreak of a communicable disease. However, if that is true, I missed it. In fact, I would be interested in any data from Tamarack Camps of any outbreak of a communicable disease in its 100-year history.”

I call this the “seat belt” argument. I've never been in a serious crash, but studies clearly show that if I were, wearing a seat belt could make the difference between life and death. The same is true for vaccination. While we may not see a lot of tetanus in this country, we still need to protect ourselves. Tetanus is a particularly hideous death, and we see so little precisely because of our vaccination efforts.

“Perhaps Camp Tamarack is unaware that over $3 billion has been awarded by the Federal Government to children and adults injured by vaccines. Maybe Camp Tamarack can assure all who will have to be fully vaccinated to attend camp that it is safe to inject numerous doses of neurotoxins like mercury, aluminum and formaldehyde into any living being. As far as I am aware, there are zero — ZERO — safety studies on injecting a neurotoxin into a living being. I would like to see where Jewish law says it is safe to inject a neurotoxin into a baby or any living being.”

This is completely wrong in every conceivable way. First, the “$3 billion” thing: vaccines are not very profitable, and people who listen to Brownstein might be tempted to sue a drug company after getting a vaccine and having something bad happen. Serious vaccination reactions are vanishingly rare, but in order to protect the public and to protect the companies that make vaccines, the government has set up a “vaccine court.” While you may sue a drug company for causing injury through a poorly manufactured vaccine, you cannot sue them simply because you think you had a reaction. This court liberally awards money to people who feel they have been injured by a vaccine. The level of evidence needed is minimal. It is meant as a safety net both for those who are truly injured and for those who think they are, even if they might not be able to prove it in a normal court.

The “toxin” gambit uses scary words out of their scientific context. Aluminum is used in some vaccines in order to help create a stronger immune reaction. This allows us to use less of the actual antigens derived from the germ. It is not present in amounts that cause harm. Formaldehyde is sometimes present in tiny amounts left over from the preservation process. Your own body manufactures more formaldehyde in a day during its normal chemical processes than you would get from a lifetime of vaccines. The tiny amount that might be left in your shots is trivial for your body to deal with.

Mercury is not present in most vaccines. It is present in a few in the form of thimerosal, a preservative that keeps vaccinations from becoming contaminated. Thimerosal in vaccines has been found in study after study to be harmless. No “neurotoxins” are injected into our children as part of the vaccination process. That is either a lie or profound ignorance of biology. Tetanus, on the other hand, produces a potent neurotoxin that kills people in a uniquely painful way.

“Maybe Camp Tamarack should take notice that there is a whistle blower at the CDC — a senior scientist who authored research papers on childhood vaccinations — who has stated that the CDC has hidden and altered data that confirmed a link with the MMR vaccine to autism. Or, perhaps they could provide an explanation of why another whistleblower scientist who worked at Merck (who manufactures the MMR vaccine) has filed a federal lawsuit saying the mumps data used to justify the MMR vaccine was falsified by Merck.”

This bears repeating: There is no link between MMR vaccines and autism. None. The “link” was from a fraudulent paper published in a British medical journal by Dr. Andrew Wakefield. The paper has been retracted and his license has been revoked due to his fraud.

Dr. Brownstein goes on to make an argument that would be funny if it weren't so dangerous. He argues that as vaccination rates have risen, so have childhood disabilities. Any 7th grade forensics student could tell you what the problem is here: just because 2 things occur at the same time does not mean 1 is the cause of the other.

For example, in the same time period cited by Brownstein, lead exposure in kids decreased dramatically, mostly due to the elimination of leaded gasoline. So was lead exposure protecting our kids from learning disabilities and autism? (For the definitive, ground-breaking book on the “rise” of autism, see Steve Silberman's Neurotribes.)

Maybe you skipped the details above and have arrived down here to the bottom of the page. Here's the short version.

Vaccination, along with water sanitation, has saved billions of lives. Most of us are too young to remember life before vaccines, but before the fifties, being a parent was terrifying. Vaccination has been shown over and over to be safe and effective, so much so that there is nothing that unites the medical community more strongly. Failing to vaccinate your child puts them at risk, and puts others' kids at risk.

Summer camps are intimate environments, with kids sharing space, clothes, water bottles. I've seen what an outbreak of a mild disease can do. Can you imagine what would happen if, say, meningitis broke out at a camp? You don't have to imagine it, all you have to do is read history.

Camp Tamarack should be lauded for their policy of full vaccination. If there is a kid who for some medical reason can't get all their vaccines, this policy will protect them from unvaccinated cabin-mates. And there is no downside to the policy.

Dr. Brownstein is wrong on the facts. That's not my opinion. What is my opinion is that doctors like him are a threat to public health. Doctors who spread incorrect information about health and disease are endangering my child and yours. They are a threat to public health. It is my personal belief that doctors who practice so strongly against the standard of care should lose their license to practice.
Tuesday, January 19, 2016

Fishy claims about best diets

We have all heard that eating fish is good for us, and the proposition is valid both empirically, and epidemiologically. But it begs a vital question just the same: good for us, compared to what?

What we know is that in general, people with diets that routinely include fish have better health outcomes than people with diets that don't. There are inevitably, however, systematic differences in such diets. People eating more fish may well benefit from fish-specific attributes, such as the omega-3 content of fatty fish, notably salmon, trout, and albacore tuna. They (we) may also benefit, however, because fish as a protein source supplants other, less salutary fare. Is the observable benefit principally derived from what the diet includes, or excludes? This is not an easy question to answer even when we wrestle with it directly, which to date we have mostly not done.

Fish is clearly good for us in the context of the prevailing, typical American diet, propagating around the globe, alas, in which the meat of pigs (i.e., bacon) is routinely garnish for the meat of cattle (i.e., burgers). Such meat-on-meat is further embellished as a matter of routine with everything from a bun of refined white flour (to say nothing of additions of not only rather copious salt, but also high fructose corn syrup), to ketchup (with more high fructose corn syrup), to such ominously vague concoctions as “special” sauce. Trading up in such context is not a challenge.

But what of the addition of fish to an already quite optimal vegetarian diet? Can we say if human health outcomes are demonstrably better with an optimized vegan diet, or an optimized pescetarian diet?

To date, to the best of my knowledge, we cannot.

To the extent that we mean what really matters most when we say “human health outcomes,” that is not a problem we are likely to redress any time soon. What really matters most is the combination of longevity and vitality; life in years, and years in life.

To show beyond meaningful doubt that any contender for best diet laurels is truly “the” champion using such a metric is a daunting challenge. We know, for instance, that nutritional effects, and inchoate taste preferences, originate in utero. We know as well that diet quality continues to influence health quality across the full expanse of the lifespan.

To prove, therefore, that Diet A is “better” than Diet B, to say nothing of Diets C-Q waiting in the wings, likely requires the randomization of women early in their pregnancies to the competing options. Because health differences are apt to be small when variations on the theme of “optimal” are being compared, the sample size would have to be huge, probably well into the thousands.

So, thousands of pregnant women would need to adhere to their assigned diet throughout their pregnancies, and then adhere to it some more during a required, standardized period of breast-feeding. Nutrients, after all, are transmitted through breast milk, as are flavors.

The true study participants, the babies, only get into the act once they are weaned and start eating solid food. At that point, the babies need to adhere to the assigned diet, forever.

Since our study metric includes longevity, and since people eating (and living) optimally see their 100th birthday far more often than the rest of us, we should plan for our study to run the better part of 100 years. The challenges are by now self-evident, I trust. Leaving alone the logistical nightmare of managing perfect fidelity to assigned diets by thousands of mothers at first, and then their newborns, we are left with a study that will cost an oppressively staggering sum, and will outlive any of the investigators involved at the start.

Suffice to say, it has not been done, and I advise against holding your breath while waiting.

Of course, we might content ourselves with lesser metrics. We certainly could compare equitably high-quality versions of vegetarian and pescetarian diets in a relatively short-term randomized trial, looking at such measures as cardiac risk markers, inflammatory cytokines, body composition, and more. Not only could such a trial be done, but frankly, it should be. My lab is working on related protocols as we speak, so we might get into the game.

We have had limited forays in this direction, looking over the years at the health effects of various foods. We have reported, for instance, that daily egg ingestion produces no discernible harms in healthy adults, hyperlipidemic adults, or even adults with coronary artery disease. But of course, this egg intake is against the backdrop of a rather typical American diet. We may well be better off eating more eggs, and fewer doughnuts, which was the thinking that motivated this line of inquiry in the first place.

My vegan colleagues, however, are quick to point out that the alleged “harmlessness” of eggs, and cholesterol, would disappear if superimposed on an optimal, plant-based diet at baseline. They may well be right, and it is a reminder to ask always about the attribution of effects to any given element of diet: compared to what?

In other cases, we have studied foods of such clearly established health benefit that our findings are of more reliably universal relevance. Nuts, for example, figure in all of the world's healthiest diets, and are consistently associated with an array of health benefits in epidemiologic research. In such context, our findings related to beneficial effects of walnuts in Type 2 diabetes and pre-diabetes may, perhaps, be spared the “compared to what?” proviso. The best of foods are good for us compared to just about anything.

By and large, though, my lab is much more about “how to” rather than “what to” when it comes to eating. We accept that the basic theme of salutary eating has been rather clear for decades, and that making far better use of what we already know is crucial, eminently possible, and much neglected. I thus hope other researchers take up the mantle for such studies as vegetarian versus pescetarian, because my team and I contend there may be a bigger fish to fry. Most of our time and energy is directed to a project all about putting what we do reliably know about diet and health to far better use for the benefit of people and planet alike.

There is, in general, something rather fishy about most claims regarding the single best way to eat. Namely, such tales tend to wag at us far more dogma than data. The matter is only decisively settled with research that for the most part has not been done, and at its logical extreme, almost certainly never will be.

As for fish per se, I am quite convinced that eating them is good for us in general, although maybe not compared to every conceivable baseline diet. But increasingly, I am preoccupied that eating them is clearly not good for the fish, or the oceans. The environmental impacts of our dietary choices are profound, and should be of increasing concern to all of us with an affection for this planet, or our children for that matter.

Claims about any given food or diet that go beyond the evidence are, in essence, fish tales- notorious for exaggeration. They are unfortunate, as they tend to obscure the reliability, volume, and consistency of evidence underlying genuinely common ground. Let us make our stand there, waders, optional.

David L. Katz, MD, FACP, MPH, FACPM, 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. He is a board certified specialist in both Internal Medicine, and Preventive Medicine/Public Health, and Associate Professor (adjunct) in Public Health Practice at the Yale University School of Medicine. He is the Director and founder (1998) of Yale University's Prevention Research Center; Director and founder of the Integrative Medicine Center at Griffin Hospital (2000) in Derby, Conn.; founder and president of the non-profit Turn the Tide Foundation; and formerly the Director of Medical Studies in Public Health at the Yale School of Medicine for eight years. This post originally appeared on his blog at The Huffington Post.
Monday, January 18, 2016

My Newark airport information technology (bad) experience

A couple of weeks ago I flew into Newark Liberty airport in transit to another destination. I had a few hours to spare, and after a very early flight from Boston, felt hungry and in need of a good breakfast. After looking around for options, I sat down in what appeared to be a reasonably upscale restaurant.

The first thing I noticed was that there were glistening iPads mounted on each table. Well, this appeared nice and modern! After activating the iPad, I had to scan my boarding pass, which after some difficulty, the iPad managed to register. I then began scrolling through the breakfast options and shortly afterwards a hostess came by and told me how the process works: I would order my food, swipe the credit card, and then the food would duly arrive. Seemed straightforward enough.

The only problem was that some of the options seemed rather complicated, with various additions and extras, and I had to keep scrolling back and forth to get to different screens. When I finally decided on an option, I attempted multiple times to swipe my credit card, but the reader appeared to be not working. The hostess tried to help, even using another credit card, but still no success. At that point, hungry and frustrated, I got up and told them I would find somewhere else to eat. Ideally, a good old-fashioned bagel shop. However, to my surprise, as I walked around the airport I noticed that almost every single eatery, be it a cafeteria or bar, had this iPad system of ordering.

When I finally settled on a small cafe in the food court, there seemed to be utter chaos in the ordering line. Customers were being told to use the iPad, get a receipt and then pay at another iPad. There was total confusion, and when I finally got my breakfast, I spoke to one of the cafe workers, expressing my frustration and asking what happened to normal traditional ordering of food. The young lady, who seemed sincere and hard-working, told me that this new system at Newark airport had been installed just 3 weeks previously. They were clearly having difficulty with it to say the least.

So it appears human contact while ordering food is going out of fashion, certainly at this airport anyway. This is a problem on a multitude of different levels:
• Customers find it more difficult to ask routine questions about their food or make special requests.
• Elderly people in particular have a hard time, as I could clearly see.
• The process takes longer, because the main rate-limiting step is not ordering or paying, but actually making the food.
• We are taking an essentially social human experience, dining, and attempting to computerize it (albeit at an airport).
• On a personal safety and hygiene front, it is a terrible idea—especially in an airport—to have hundreds of people who are about to eat touching the same screen

Undoubtedly this experiment at Newark airport has cost hundreds of thousands of dollars, paid to IT folks and consultants. But has it really improved anything and is it what customers really want? Unfortunately, what many people from the IT world don't fully grasp is that while information technology is definitely the way of the future, not every human process is amenable or desirable to mechanization and technology.

Just as what we've seen at the frontlines of healthcare over the last decade, more IT isn't necessarily always the answer, and at a point actually reduces the user experience and customer satisfaction. Certain technically inclined people, who are happy spending their whole day sitting behind a screen, need to realize this.

Service is a human experience and people appreciate good service. Let's take supermarket checkouts as an example. As much as corporations want to promote self-service kiosks, most people simply have no interest in using them for their weekly shops.

I personally hope that Newark's experiment with this IT system fails. Not just because of the bad experience of customers, but because I also remembered my interaction with that sincere and hard-working cafeteria worker who told me all about this new system. No doubt she was just told by her superiors a few weeks ago, “Here is the new product; make it work,” perhaps not realizing another fundamental truth as she works so hard to get the new system up and running. People like her are just pawns in the process. Because if this works out the way some of her bosses intend, she and many others will almost certainly not be needed there anymore. That's what happens when the bottom line trumps good service and common sense.

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.

Drug prices and costs

Drug pricing has become a hot topic. Maybe I have become sensitized to it, but it seems like there is something about the cost of pharmaceuticals everywhere I turn in medical journals, online discussion groups and mainstream news outlets. Just this past week, the front page story in the business section of the New York Times ran a long profile of a pharmaceutical executive that centered on his company's controversial pricing practices. The article mentioned that pricing is now generating lawsuits and potential Congressional action.

Why all the attention? I am guessing (really, just guessing) that there are a few reasons.

First, despite the overall modest growth in health expenditures in the U.S., pharmaceutical spending is rising more rapidly. In fairness, other costs may be slowing precisely because the wider use of more effective and more expensive medications is preventing the need for other treatments. Think, for example, of an anti-TNF monoclonal antibody “biologic” that reduces the need for hospitalizations and GI surgery for patients with Crohn's disease. It is much easier to “see” and quantify the drug expenditure than the downstream “savings.”

Second, more and more people have high deductible health insurance plans and narrow benefits packages, so that it is increasingly common for patients to face pharmaceutical costs. This is exacerbated in many cases by coincident facility fees for infusion therapies, which are already among the most expensive agents. More patients facing higher costs leads to greater public awareness.

Finally, everybody loves an outrageous anecdote, so drug company moves like the “repricing” of a drug from $13.50 per pill to $750 per pill, as detailed in the Times story, become irresistible evidence of just how insane U.S. health care financing really is.

Despite all the attention, there's at least 1 issue that is not getting much play. I haven't seen a lot written about the difference between drug prices and drug costs. In fact, the terms often get used more or less interchangeably because we are used to normal commercial exchanges where the seller's price is equal to the buyer's cost. In the anything-but-normal world of pharmaceutical pricing, variable pharmacy benefits, negotiated coverage, deductibles, co-pays and the like, it is worth pointing out that patients are all facing different costs, and the only constant is the manufacturer's price. Just to make things a little more complicated, that price is generally quite arbitrary and disconnected from the actual costs of production, leading to a different kind of cost/price discordance.

The bottom line is that we might be able to make more sense of this if we are a little more careful in our choice of words. I think we should explicitly call out the drug makers for their crazy prices, which only become our costs if we are willing to pay the bill.

What do you think?

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. He then held a number of senior positions at Mount Sinai Medical Center prior to joining North Shore-LIJ. He is married with two daughters and enjoys cars, reading biographies and histories, and following his favorite baseball team, the New York Yankees, when not practicing medicine. This post originally appeared at his blog, Ausculation.
Friday, January 15, 2016

Sherpas wanted

2015 was a hard year for my father. He's a remarkably healthy 89-year-old, with no diabetes, no hypertension, and (most importantly) he's got a sharper mind than I do on most days. Perhaps that's a low bar to cross, but it's pretty good for him. I think this is from all the crossword puzzles he's done over the years.

Dad's troubles started around the middle of the year when he started having low back pain. This pain progressed from mild pain to being so severe that he required a wheelchair to get around the house. This is the man who, a year after breaking a hip, was impossible to keep off of a stepladder to fix something on his roof. It was a big change. After trials of conservative treatment, he was eventually diagnosed with a compression fracture of his lumbar spine (presumably from steroids he took for an inflammatory problem).

Given the severity of his pain, he ended up going to a back specialist to get a procedure to fix the compression fractures and, presumably, reduce his pain. Unfortunately, his pain increased and changed after the procedure. It got so bad, in fact, that he ended up being hospitalized in November for pain control.

The hospitalization was confusing for both him and me. It wasn't clear if his pain was from a problem in his back, as it had moved to his leg. Yet while in the hospital he didn't get any radiological study to determine the source. Plus, he's quite resistant to the effects of narcotic pain medications. I really don't like to intervene on behalf of family members unless it's absolutely necessary, but I finally ended up talking to the hospitalist who was quite nice, but not much help. Dad was being discharged to rehab the next day and I still wasn't clear on what was wrong after a week in the hospital.

He spent the next few weeks in bed most of the time, continuing in significant pain despite increasing dose of narcotic medications. His primary care provider (who I like) has had enough and feels Dad's pain is from spinal stenosis, an arthritic condition that causes compression of the nerves in the back. There is a surgical cure for this, which, despite Dad's age, he's a reasonable candidate for. Any surgical risk is outweighed by the near 100% chance of things being terrible if we do nothing.

The reason I'm writing about this is not that I think his care was unusually bad; the problem is that his experience, especially in the hospital, is a frequent experience many of my patients have with their care. My dad has the great advantage of having a doctor he can talk to any time, which is a lot more than most people get. He colorfully described his hospital stay as “kicking the can down the road,” explaining that it seemed like nobody was trying to fix the actual problem but rather just do enough on him so they could pass him on to someone else and move on to the next thing.

I see this with painful frequency in my practice, which is especially frustrating since I am willing and able to talk to other doctors participating in the care of my patients. As much as I want to coordinate their care, I can't help them if the other folks caring for them aren't interested in working along with me. Calling the hospitalist and primary care provider for my dad was not a simple process, and I couldn't help (despite their absolute cordiality) feeling like I was adding extra to their already busy days. They aren't bad, they're just normal in this. It's obvious that our system is anything but patient-centered.

This all got me thinking about how to use my unique situation to improve this problem. It seems to me that what people need is some sort of medical Sherpa that can trek with them through the unfriendly and unfamiliar world of health care that exists outside of my office. People are quick to accept non-answers from specialists, to be misconstrued by ER doctors, and to spend a week in the hospital without knowing what is going on. Other doctors are far too willing to accept fragmented care, not knowing the context of the current hospitalization or outpatient consultation.

I'm not sure how this could work, but I'm pretty sure that care will continue to be fragmented until we do something to defragment it. This costs money, causes errors, and, as is the case of my father, puts people through far too much unnecessary pain. He's getting help now, but I'm pretty sure he's gotten far better care because of my advice to him and my intervention. How much more would he have had to suffer to get attention? How many folks are there out there who are in pain (or worse) because of this problem?

I'll let you know what I come up with. And keep my dad in your thoughts/prayers. It sucks to have someone you love suffer and to feel powerless to help.
Thursday, January 14, 2016

Orange is the new nudge

A few years ago, I read the book Nudge, and ever since I've been fascinated by the concept. A nudge is a stimulus that leads to a desired behavior but doesn't force it. For example, in school cafeterias placing fruit at eye level results in more fruit consumption. No one is forced to eat more fruit and potato chips aren't banned, but more fruit gets eaten. Another example is painting horizontal lines on highways, which causes drivers to slow down. So, the million dollar question for hospital epidemiologists is: how can we nudge health care workers to wash their hands?

There's a very interesting paper in Health Psychology that attempts to identify hand hygiene nudges (free full text here). At the University of Miami, investigators randomized approximately 400 health care workers and visitors at the entrance to an ICU into 3 groups: a control group that received no stimulus, a group that was given an olfactory stimulus (citrus smell dispersed by an aroma dispenser), and a group given a visual stimulus (a photograph of eyes placed above the alcohol gel dispenser). The last group was subdivided: for some the photo was middle age male eyes and for others the photo was female eyes.

Hand hygiene in the control group (no stimulus) was 15%. Those who received the olfactory stimulus had a hand hygiene compliance of 47% (P=0.0001). The photo of female eyes was associated with a compliance of 10% (P=0.626), and male eyes, 33% (P=0.038). So, a photo of male eyes above the alcohol gel dispenser doubled hand hygiene compliance and citrus smell tripled it.

The same investigators in a previous study showed that citrus scent was associated with significantly higher rates of hand hygiene compliance when medical students and interns examined standardized patients in a simulation center.

Start slicing the oranges!

Michael B. Edmond, MD, FACP, is a hospital epidemiologist in Iowa City, IA, with a focus on improving the quality and safety of health care, and sees patients in the inpatient and outpatient settings. This post originally appeared at the blog Controversies in Hospital Infection Prevention.
Wednesday, January 13, 2016

Am I too old for a colonoscopy?

Most of us are familiar with the concept of medical guidelines. These are sets of criteria that are supposed to “guide” physicians facing certain medical circumstances.

As physicians know, and often lament, guidelines over time morph to become mandates. Even though by definition, a guideline is voluntary, many hospital oversight committees and insurance companies require physicians who deviate from guidelines to explain their actions.

The U.S Preventive Services Task Force guideline states that folks 75 and older should not receive screening colonoscopies. The reason is that medical studies have demonstrated that the benefits of colon cancer screening in this age group is not justified by the risk and expense of the effort. Of course, there is an age when colonoscopy does not make sense, but I'm just not sure what this

magic number is.

Consider these 2 hypothetical patients.

(1) A 78 year old man in excellent health has never had a screening colonoscopy. Should he be denied this as it will violate the guideline even though this guy has a decent chance of living another decade?

(2) A 60 year old comes to my office from his dialysis session dragging his oxygen tank behind him. He's never had a colonoscopy. Does a screening study really make sense here?

Guidelines and all their ilk are a 1-size-fits-all approach to a profession that needs to individualize its advice to living, breathing human beings. There's more absurdity to come. Insurance companies and the government are increasingly tracking physicians to assure that they are following all appropriate guidelines. Those who deviate face the prospects of decreased reimbursements and being highlighted publicly on websites and elsewhere as being deficient.

How easy do you think it would be to argue your case to an insurance company that a particular guideline didn't apply to a particular patient? Having had the thrill and pleasure of dealing with medical insurance companies and the government, I can answer this in a quiz format, 1 of my preferred educational tools. Please arrange the following 4 actions in increasing order of difficulty.
(1) Stumbling into a bee hive while walking in the woods
(2) Swallowing glass shards
(3) Watching C-SPAN for 24 hours without interruption
(4) Reversing a claim of Medical Guideline Violation

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.
Tuesday, January 12, 2016

A world with no pharmacies

Industry funding of research has always been a rather fraught topic. In the immediate aftermath of what we might reasonably call the “Coca-Cola calorie debacle,” or perhaps “GEBNgate,” it is all the more so. But in this domain, as in so many, the rush to summary judgment (in either direction) obliterates nuance fundamental to real understanding, and obscures a middle path conducive to important and even crucial advances.

Consider, for instance, that were we to take admonishments against industry funding to their logical extreme, 1 thing they would yield for certain is a world with no pharmacies. Virtually everything in the modern pharmacopoeia is a product of industry-funded research.

For some few of you, devoted, perhaps to natural remedies, and thus far spared by happenstance or youth the need for modern medical intercession, a world with no pharmacies may sound good. But most of us, even those of us very devoted to lifestyle as medicine, and very disinclined to take actual pharmaceuticals, have at times unavoidably been their beneficiary. I am, and I have, and thus have cause to be grateful that somebody funded the studies of the drugs I happened to need. So, too, for surgery, the tools of which also advance preferentially through the advent of industry funding.

So here, as in virtually all such scenarios where a complex topic warrants a good scrubbing, we have baby and bathwater in the same tub, and a perilous tendency to overlook the distinction.

Are there important liabilities of industry funding, of pharmaceuticals and anything else? Of course. Interested parties infuse a research agenda with a predictable bias. That bias in turn can corrupt methods from the outset, sometimes rather subtly, and foster the propagation of systematically misleading results.

That is not the only risk. When research costs are covered by private rather than public dollars, the funder might choose to suppress unfavorable findings, or to release findings selectively, or slowly. We might thus wind up with the truth, and maybe even nothing but the truth, but something so far removed from the whole truth as to constitute a falsehood. The famous case of Vioxx is a precautionary tale occupying just such terrain.

But on the other hand, were there no industry funding of pharmacotherapeutic advance, the noteworthy declines in cancer mortality would almost certainly not have been seen. The variety of antibiotics that, thus far at least, defend us admirably against all but the most exceptionally resistant microbes, would not be at our disposal.

Of comparable relevance, funding by the most ostensibly unimpeachable sources is no assurance against just such liabilities. The premier source of biomedical research funding in the U.S., the National Institutes of Health, is by no means devoid of its own native biases, and even potential for conflicts of interest.

Just like any other funder, the NIH favors positive results. The occasional study may be aimed at debunking, but most studies are infused by the hope of positive outcomes. This means that the researchers funded by the NIH are biased as well, hoping to show positive results. There are rather salient reasons why.

For 1 thing, all funders, ultimately, have funders of their own. In the case of NIH, it is the U.S. Congress, processing the money we, the people, provide in our tax dollars. NIH must remake the case for its slice of the pie as the federal budget is renegotiated every year, and breakthrough results certainly help. The expenditure by NIH last year on lackluster results does not help this cause.

Another problem is that our statistical conventions make positive results generally more reliably positive (albeit, far from perfectly so) than negative results are reliably negative. I will spare you the analytical weeds here, and keep it at a very high level: one of the most common explanations for a negative result at odds with hope and expectation is lack of statistical power to find the effect being sought. This, in turn, results from too small a sample.

So, you think, just use a larger sample! Good idea, but human clinical trial costs are related directly to sample size. I have a precautionary tale to tell.

My lab received funding from the NIH some years ago to run the first ever, placebo-controlled, randomized trial of an intravenous nutrient infusion in widespread, but unproven, use for fibromyalgia (among other things). The funding was for a preliminary, rather small, pilot study, with the understanding that the conduct of the trial, and outcome, would determine next steps.

Our treatment group did improve significantly. In fact, the effect size we saw was greater than reported for FDA-approved drugs for the same condition. However, our intravenous placebo produced a very robust placebo effect, so our control group improved substantially as well, albeit less. The result was that the between-group differences favored active treatment, but were not statistically significant. These results were negative, but not reliably so.

This seemed to be a perfect argument for a larger, definitive study. The pilot had proven our ability to apply appropriate methods, and run the study in this challenging population, but left efficacy in doubt. But we could not secure funds for a definitive trial. Reviewers at the NIH simply referred to the “negative” pilot results, and said: no thanks. We struggled to get our results published as well, despite the robustness of the study methods, because journals were no more favorably disposed to such murky outcomes than were funders. We prevailed, but only in a far from top-tier journal.

Such is the peril of pilot studies and negative results: One may not be able to say whether there is a true lack of effect, or merely lack of evidence of effect. In the case of intravenous nutrients for fibromyalgia, the result was a very unfortunate dead-end, leaving the matter unresolved to this day.

There is yet another problem with federal funding. While individual grants receive excruciating review, there is concern that the overall allocation of biomedical research dollars may be misdirected. This concern has been voiced by colleagues in Preventive Medicine, and echoed by none other than a Nobel Prize-winning, former NIH director.

In addition, politics may introduce bias directly. Colleagues directly affected tell me that during the Bush years (the second Bush), NIH grants addressing harm reduction strategies, such as needle exchange, were summarily rejected on ideological grounds, despite their clear, epidemiologic promise.

There is one more handicap to NIH, or other federal agency funding: these sources are none too enthusiastic about any proprietary advance, and tend not to fund studies of same. But what if there is legitimate hope that a proprietary, branded app, technology, device, program, algorithm, or even food has specific, favorable health effects? The only likely source of proof one way or the other is funding from the intellectual property owner, because no one else is apt to pay.

Having received funding from the NIH, the CDC, private foundations, and industry sources over the years, I can attest to personal bias in every instance, i.e., with every study, my team and I were “hoping” for a particular outcome. Why on earth would we even bother to do a study (they are rather tedious to design, fund, and run) if we didn't care about the outcome? The answer is, we wouldn't; no one would. As soon as one does care about the outcome, bias is inescapable.

But that is biased preference. Biased methods, in contrast, are avoidable, or nearly so. Methods, then, and safeguards against bias in the study protocol, are the more robust measure of a study's merits than the funding source, or the native preferences of funder or investigators.

We actually have a very good template in place for the research equivalent of having our cake and eating it too, i.e., allowing for industry funding and protecting against systematic distortion. That template is the very matter with which we began: funding of drug studies. The for-profit pharmaceutical companies pay these (often colossal) bills, but the FDA standardizes the criteria. A variation on that same theme could work for all industry funded research.

My initial, fairly obvious standards for industry-funded research include:

1) the customary defenses against bias and confounding, whenever practicable: randomization; double blinding; concomitant control

2) contractual protection of the right to publish, independent of study outcomes

3) complete research team autonomy with regard to study management

4) complete research team autonomy with regard to data analysis, interpretation, and manuscript preparation

A final consideration might be disclosure at the time of publication regarding satisfaction of these criteria. Funding sources are already disclosed routinely. We might add, without much fuss: “This study does/does not satisfy Standard Criteria for Research at Low Risk for Undue Influence by the Funding Source.” The papers that did should be more trusted, and indeed published preferentially, as compared to those that did not. The same check list could be applied to all entries at clinicaltrials.gov.

To the best of my knowledge, every research contract at my lab over the past 20 years has met the criteria above. As a result, we certainly have published industry-funded studies with negative results the funder did not love.

Absent industry funding, research in pharmacotherapeutic advances would be set back decades. I think few propounding the perils of industry funding, of which there clearly are, pause to consider what its abolition would mean to the offerings of any modern pharmacy; they would be all but annihilated. One might even argue that the problem is less industry funding, and more the lack of a level playing field. The pockets of some funders, namely those who deal routinely in patents, are much deeper than those of others, and this in turn produces a distinct lack of parity in the capacity to generate evidence. When evidence-based medicine becomes revenue-based medicine, we all have a problem.

That problem will not be solved by summary judgments, dismissive of such subtleties. We have in our culture, arguably, killed expertise. We do the same to dialogue at our peril.

Use of the word “conflict“ has become an almost reflexive disparagement of industry funded research; a meme, of sorts, invoked presumably to highlight one's own virtue. Those addressing the matter thoughtfully, however, have begun to note that such funding may portend confluence rather than conflict, and the distinction should be made.

That distinction can be all but self-evident. Coca-Cola, clearly, should not be subsidizing our understanding of “energy balance.” Trade organizations representing nuts, or produce, or oils funding legitimate examinations of specific health effects of their products, or wearable health tech companies funding studies of their proprietary offerings, are another matter. But for the confluence of their interest and funding, research in such areas may simply lag behind.

Propriety can lead to credible funders, and clear criteria for research findings we can trust. Sanctimony leads reliably only toward the domain of history's greatest blunders.

It is also, predictably, parent to hypocrisy when the thing you assert with self-righteous zeal is wrong, becomes the very thing you need. I have yet to meet anyone with acute ureteral colic, or pancreatitis, holding forth in the Emergency Department about who funded the trials of the drugs they need. Their message tends to be much more primal: Help me!

We generally can do so, and industry funded research is much of the reason. In a world with no pharmacies, we would look on at such misery rather helplessly. We should take steps to foreclose on true conflicts in research. But we should allow for confluence, too, and keep the pharmacies open.

This post by John H. Schumann, MD, FACP, originally appeared at GlassHospital. Dr. Schumann is a general internist. His blog, GlassHospital, seeks to bring transparency to medical practice and to improve the patient experience.

Hedge fund to the rescue of charitable care

Tucked away amid the deluge of awful news from California in the wake of a mass shooting was a story about a tentative deal in which a hedge fund (BlueMountain Capital Management) received a green light to manage a chain of non-profit hospitals (Daughters of Charity Health System) that is on the brink of bankruptcy. Said hospitals span the state from San Jose to Los Angeles.

Notable facts about the deal include:
• It'll be the largest transaction involving a non-profit system in California history.
• It'll be the first time a state-level decision governing non-profit hospitals has included a hedge fund.
• The hedge fund is paying $100 million up front for the right to purchase the hospitals within 3 years. (Final costs of which will be many hundreds of millions more.)

California's attorney general had to give her blessing to the deal. She instituted strict conditions to permit the option, which are listed at the bottom of this post. On the plus side, community-serving hospitals stay open, and stay non-profit for a period of years. They are infused with cash which a) keeps them open b) allows capital improvements c) keeps their employees working and d) keeps their pensions funded.

Potential downsides are that the hedge fund has no prior experience managing a hospital system. It will create a spin-off to do the managing. Some community advocates are worried the hedge fund will (years from now) turn the hospitals for-profit, consolidate them, shed employees, and thus hurt the various communities' access to care.

It will be an interesting deal to watch. No one has ever said health care is simple. Or that it's cheap.

From the San Jose Mercury News article:

AMONG THE CONDITIONS [California AG Kamala] HARRIS IMPOSED:
1. For 10 years, O’Connor Hospital, Saint Louise Hospital and Seton Medical Center and St. Francis Hospital in Los Angeles must operate as acute care hospitals and offer emergency services.
2. For 10 years, Seton Coastside must operate as a skilled nursing facility with 24-hour emergency services and a minimum of 116 licensed skilled nursing beds.
3. For 10 years, the 6 facilities must provide the same types and/or levels of emergency and nonemergency services to Medi-Cal beneficiaries and maintain Medi-Cal managed care contracts at each of the facilities.
4. A sum of $180 million must be invested in capital improvement expenditures at the facilities.
5. Charity care for needy patients and community benefits must be provided at historical levels.
6. All facilities must meet seismic compliance requirements until 2030.

Is this a Faustian bargain or was it the only viable option?

This post by John H. Schumann, MD, FACP, originally appeared at GlassHospital. Dr. Schumann is a general internist. His blog, GlassHospital, seeks to bring transparency to medical practice and to improve the patient experience.