"Clinical Decision Making: Evidence Is Never Enough"

A senior resident, a junior attending, a senior attending, and an emeritus professor were discussing evidence-based medicine (EBM) over lunch in the hospital cafeteria.
"EBM," announced the resident with some passion, "is a revolutionary development in medical practice." She went on to describe EBM's fundamental innovations in solving patient problems.
"A compelling exposition," remarked the emeritus professor.
"Wait a minute," the junior attending exclaimed, also with some heat, and presented an alternative position stating that EBM merely provided a set of additional tools for traditional approaches to patient care.
"You make a strong and convincing case," the emeritus professor commented.
"Wait a minute," the senior attending exclaimed to her older colleague, "their positions are diametrically opposed. They can't both be right."  

The emeritus professor looked thoughtfully at the puzzled physician and, with the barest hint of a smile, replied, "Come to think of it, you're right too."

So begins the Users' Guide to Medical Literature issue #XXV, "Principles of Applying the Users' Guides to Patient Care", published 10 years ago, almost to the day in JAMA (JAMA 2000;13:284;1290-6). I am enjoying re-reading it, as I now appreciate the authors' evolving positions acknowledging the complexities of modern practice and the need to hold together apparent dualities. They acknowledge their continued commitment to the scientific rigor of EBM:

In 1992, in an article that provided a background to the Users' Guides, we described EBM as a shift in medical paradigms.² In contrast to the traditional paradigm, EBM acknowledges that intuition, unsystematic clinical experience, and pathophysiologic rationale are insufficient grounds for clinical decision making, and stresses the examination of evidence from clinical research. The philosophy underlying EBM suggests that a formal set of rules must complement medical training and common sense for clinicians to effectively interpret the results of clinical research. Finally, EBM places a lower value on authority than the traditional paradigm of medical practice.

However, they point out that the complexities of the world often call for more than one way of approaching problems:

While we continue to find the paradigm shift a valid way of conceptualizing EBM, as the scenario suggests, the world is often complex enough to invite more than 1 useful way of thinking about an idea or a phenomenon. In this article, we describe the 2 key principles that clinicians must grasp to be effective practitioners of EBM. One of these relates to the value-laden nature of clinical decisions; the other to the hierarchy of evidence postulated by EBM. 

A few paragraphs into the paper, we come to a surprising heading, which serves as the title for today's post: "Clinical Decision Making: Evidence Is Never Enough". Wow, is this not a bit heretical, especially coming from the cradle of EBM? What do the authors mean by this? To illustrate this they develop three scenarios, each involving a patient with pneumococcal pneumonia, a disease for the treatment of which plenty of strong evidence exists. Yet, depending on the context of the patient's situation, treatment decisions may or may not be straightforward. Their examples of a terminal cancer patient who herself may forgo treatment, an elderly demented nursing home patient with no family, whose treatment decisions have to be made solely by the clinicians, and a 30-year-old mother of two, whom only Lord Voldemort would consign to non-treatment. The point being that evidence of effectiveness, in this case for the treatment of pneumococcal pneumonia, is necessarily applied to the particular circumstance at the bedside. In other words, some value judgments are employed to apply the existing evidence to a trade-off decision. Quantifying this process is far from a clear science:

Acknowledging that values play a role in every important patient care decision highlights our limited understanding of eliciting and incorporating societal and individual values. Health economists have played a major role in developing a science of measuring patient preferences.^14-15 Some decision aids are based on theassumption that if patients truly understand the potential risks and benefits, their decisions will reflect their preferences.¹⁶ These developments constitute a promising start. Nevertheless, many unanswered questions concerning how to elicit preferences, and how to incorporate them in clinical encounters already subject to crushing time pressures, remain. Addressing these issues constitutes an enormously challenging frontier for EBM.

Switching gears somewhat to delve into some of the pragmatic issues, the authors talk about the hierarchy of evidence, acknowledging the superiority of systematic clinical observation over ad hoc anecdotal evidence as a tool to reduce common threats to inference validity. However, they loudly and clearly state that in practice one size does not fit all:

Clinical research goes beyond unsystematic clinical observation in providing strategies that avoid or attenuate the spurious results. Because few, if any, interventions areeffective in all patients, we would ideally test a treatment in the patient to whom we would like to apply it. Numerous factors can lead clinicians astray as they try to interpret the results of conventional open trials of therapy, which include natural history, placebo effects, patient and health worker expectations, and the patient's desire to please.

... and offer the following hierarchy of evidence for individual treatment decisions:

Table 1. A Hierarchy of Strength of Evidence for Treatment Decisions

So, for a patient encounter, the most robust kind of evidence is the N of 1 trial! Not too coincidentally, I came to the same conclusion here. With a few caveats, the authors confirm the feasibility of this undertaking:

N of 1 RCTs are unsuitable for short-term problems; for therapies that cure (such as surgical procedures); for therapies that act over long periods of time or prevent rare or unique events (such as stroke, myocardial infarction, or death); and are possible only when patients and clinicians have the interest and time required. However, when the conditions are right, N of 1 RCTs are feasible,^24-25 can provide definitive evidence of treatment effectiveness in individual patients, and may lead to long-term differences in treatment administration.²⁶

They go on to say that applying results based on group data may be fraught with erroneous assumptions:

When considering any source of evidence about treatment other than N of 1 RCTs, clinicians are generalizing from results in other people to their patients, inevitably weakening inferences about treatment impact and introducing complex issues of how trial results apply to individuals.

They again stress the importance of the individual encounter and making collaborative decisions in the context of the patient's values:

Thus, knowing the tools of evidence-based practice is necessary but not sufficient for delivering the highest-quality patient care. In addition to clinical expertise, the clinician requires compassion, sensitive listening skills, and broad perspectives from the humanities and social sciences. These attributes allow understanding of patients' illnesses in the context of their experience, personalities, and cultures.

They rightfully treat scientific evidence as the foundation of practice, but not the whole of it. Indeed, they conclude that

A continuing challenge for EBM, and for medicine in general, will be to better integrate the new science of clinical medicine with the time-honored craft of caring for the sick.

I really like the tempered tone of this paper, paying homage not only to the science, but also to the art of medicine. It is clear that the authors have evolved with the field, and if these giants can evolve, so can we. Clearly, in the art of medicine, "evidence is never enough".

    

  

   

   

      

Assume a spherical cow

You know that joke about the farmer whose cows are not producing enough milk? A university panel gathers under the leadership of a theoretical physicist. They analyze each aspect of the problem thoroughly and carefully, and after much deliberation produce a report, the first line of which is "First, assume a spherical cow in a vacuum". This joke has become short-hand for some of the reductionist thinking in theoretical physics, but it can just as easily personify the field of statistics, upon which we rely so heavily to inform our evidence-based practices.

Here is what I mean. Let us look at four common applications of statistical principles. First, descriptive statistics, usually represented by Table 1 in a paper, in which we are interested in understanding the measures of central tendency such as the mean and median values. I would argue that both measures are somewhat flawed in the real world. As we all learned, a mean is a bona fide measure of central tendency in a normal or Gaussian distribution. And furthermore, in such a distribution 95% confidence intervals are bounded by 2.5x the standard deviation from the mean. Although this is very convenient, few things about human biology are actually distributed normally, while many cluster to the left or to the right of the center creating a tail on the opposite side. For these skewed distributions a median is the recommended measure to be used, bracketed by the boundaries of the 25% to 75% range of the values, or the interquartile range. But in a skewed distribution it is exactly the tail that is its most telling feature, as described so eloquently and personally by Stephen J. Gould in his "The Median Isn't the Message" essay. This is especially true when more specific identification of characteristics precipitates the numbers dwindle; e.g., if instead of such general measures as blood pressure among all-comers you want to focus on morning blood pressures in such specific group as African-American males with a history of diabetes and hypercholesterolemia who attend a smoking cessation program, say. And this is important because at the level of the office encounter each patient is a universe of his/her own risk factors and parameters that does not necessarily obey the rules of the herd.  

Second, analytic modeling relies on the assumption of normality. To overcome this limitation we transform certain non-normal distributions to their log forms, for example, to normalize them in order to force them to play nicely. Once normalized, we perform the prestidigitation of a regression, reverse-transform the outcome to its anti-log, and, voila, we have God's own truth! And even though statisticians tend to argue about such techniques, in the real world of research, where evidence cannot wait for perfection, we accept this legerdemain as the best we can do.

The next example I will use is that of pooled analyses, specifically meta-analyses. The intent of meta-analyses is to present the totality of evidence in a single convenient and easily comprehended value. One specific circumstance in which a meta-analysis is considered useful is when different studies are in conflict with one another, as for example, when one study demonstrates that an intervention is effective, while another does not show such effectiveness. In my humble opinion, it is one thing to pool data when studies suffer from Type II error due to small sample sizes. However, what if the studies simply show opposite results? That is, what if one study indicates a therapeutic advantage of treatment T over placebo P, but another shows the exact opposite? Is it still valid to combine these studies to get at the "true" story? Or is it better to leave them separate and try to understand the potential inherent differences in the study designs, populations, interventions, measurements, etc.? I am not saying that all meta-analyses mislead us, but I do think that in the wrong hands this technique can be dangerous, smoothing out differences that are potentially critical. This is one spherical cow that needs to be milked before it is bought.    

The last cow is truly spherical, and that is the one-on-one patient-clinician encounter, wherein the doctor needs to cram the individual patient with his/her binary predispositions into the continuous container of evidence. It is here that all of the other cows are magnified to obscene proportions to create a cumbersome, at times incomprehensible and frequently useless pile of manure. It is one thing for a clinician to ignore evidence willfully; it is entirely another to be a conscientious objector to what is known but not applicable to the individual in the office.

But let's remember that I, as a health services researcher and a self-acknowledged sustainability zealot, am in awe of manure's life-giving properties. Extending the metaphor then, this pile of manure can and should be used to fertilize our field of knowledge by viewing each therapeutic encounter systematically as its own experiment. The middle way is that between the cynicism of discarding and blind acceptance of any and all evidence. That is where the art of medicine must come in, and the emerging payment systems must take it into account. Doctors need time, intellectual curiosity and skills to conduct these "n of 1" trials in their offices. If the fire hose of new data insists on staying on, this is the surest way to direct "conscientious and judicious" application of the resulting oceans of population data in the service of our public's health. And that should make the farmer happy, even if his cows are spherical.                  

Why medicine is not like groceries

When I was in training as a Resident and a Fellow, I remember taking only a couple of sick days over the entire 6-year period. And I had to stay home because I could not stop praying to the porcelain Goddess during a bout of a particularly nasty flu, despite a vaccination. I actually took pride in my health record, and attributed it directly to being rather sickly as a child. Well, not really sickly; I just contracted all of the childhood illnesses that prevailed at the time in my geography.

Yes, I spent my childhood in Odessa, Ukraine, where I got vaccinated against polio and smallpox, but not against measles, mumps, rubella, chicken pox, whooping cough or any other diseases that our children in the West will never contract. So, every couple of months I would succumb and have to stay home with a fever and a rash, and my mother would call my pediatrician who would come and visit me in our home promptly to examine me and, most of the time, reassure my mother that I would likely survive this time. And then, at the end, I was promptly seen at the clinic to be sure that I had recovered completely.

This is why Dr. Gaulte's entry on KevinMD got me thinking. I know that we have a hard time seeing shades of gray, but see them we must. Even if something seems bad to its core, some things about it may not be horrible. For example, we can argue whether home visits are the most efficient way to practice medicine, but we cannot argue the fact that healthcare in the USSR afforded me access to this primary care service. As it afforded it to every citizen, child or adult. Yes, I am thankful that I did not require any serious life-saving interventions, as those would surely have been either unavailable or substandard. But then again, why should the need for heroics be the rule and not the exception in a relatively healthy population? Should we not instead throw our energies into addressing common things? My point is that, despite its many undisputed flaws, the socialized medicine in the USSR provided access to a healthcare system when it was needed, albeit not one that I would want if I required some state-of-the-art intervention. But again, the vast majority of a reasonably healthy population should not routinely require high technology medicine. So, a modicum of access to a reasonable system is not something to sneeze at. Take it from someone who lived it and did a lot of sneezing. And lest I be misquoted, I want to be very clear that I am not in any way advocating emulation of the Soviet style system, but merely pointing out that some things about it were not all bad. Just as some things about our catastrophe-focused system are not all bad. What is needed, as always, is some middle way.

Another point about the post. Comparing healthcare access to food? As already pointed out by a commenter, our food system is far from an example of free market success, as it is heavily subsidized by our tax dollars. Of course, one can argue that this centralization of food production has been a huge environmental and health disaster for our nation. So, this would appear to be an argument for decentralizing everything. If only healthcare were as simple as food... 

Food happens to be a very bad analogy for our healthcare system, and here is why. Although we now indulge in high-technology food engineering, the reality is that food is a simple enterprise. If one has access to even a small plot of land, virtually anyone can produce their own food. As an example, people in cities and suburbs are beginning to raise their own back-yard chickens, and community gardens are springing up in large urban centers. If one cannot grow his/her own food, farmers' markets are making a big comeback, and not just in rural areas. These locally grown healthy alternatives to mass-produced E. coli and salmonella-contaminated products are inexpensive, and many farmers are willing to barter their wares for services and products that customers can offer. So, food, while necessary for survival, is fundamentally a low-tech enterprise. Along these lines, one could compare food to medicine, but the medicine prior to the Industrial era, when technology was non-existent and our doctors and farmers had far more similar business models. A doctor was a part of the community, there were no $10,000-a-week treatments, and bartering was acceptable in the doctor's office. Today's impersonal behemoth healthcare system with its fancy shiny and expensive gadgets, coupled with reimbursement rates in direct proportion to higher technology utilization, can hardly be compared to authentic food production. Simply put, while almost anyone in theory is able to access good food cheaply (the fact that we choose not to does not impact this point), no such possibility exists in the current healthcare system in the US.

Well, time to summarize my ramblings. 

Point #1: Not everything in an evil system is evil. It is useful to recognize paradoxically good points and see whether and how we can apply them to our situation. 

Point #2: Comparing access to healthcare to access to food is sophomoric at best, perpetuating a false analogy.

Point #3: Can it be that Roemer's rule is at play in our entire healthcare system? That is, since we have built a system for catastrophic health crises, now catastrophic health crises must be the rule and not the exception?

Think about it. Tell me if you think I am correct or completely out in the left field.            

        

Allopathic medicine and CAM: Nonoverlapping magisteria revisited?

Stephen J. Gould is known to most of us as the evolutionary biologist who brought much scientific thought on evolutionary science to the public. A self-acknowledged Jewish agnostic, he also struggled with how to help the world hold two seemingly conflicting philosophies: that of science and that of religion. He discusses some of his views in this essay and at more length in his book Rocks of Ages. In the essay he says the following:

The lack of conflict between science and religion arises from a lack of overlap between their respective domains of professional expertise—science in the empirical constitution of the universe, and religion in the search for proper ethical values and the spiritual meaning of our lives. The attainment of wisdom in a full life requires extensive attention to both domains—for a great book tells us that the truth can make us free and that we will live in optimal harmony with our fellows when we learn to do justly, love mercy, and walk humbly.

Gould coined the idea of "nonoverlapping magisteria" to describe the complementarity of rather than a conflicted relationship between these two domains of human condition. In this view he echoes another iconic scientist of the last century, Albert Einstein, who concluded that "Science without religion is lame. Religion without science is blind". Both scientists seem to boil the complementary nature of the two fields down to the idea that science asks the question "how?" and religion asks the question "why?", both so necessary for our understanding of life in this Universe. Thus, forcing oneself or others to choose between the two creates a false dichotomy so prevalent in our discourse today.

Along the same lines, I am struck by the nearly always contentious and occasionally hostile conversation about the role of complementary and alternative medical (CAM) modalities alongside of our traditional Western style allopathic medicine. Both sides seem to imply that there is no room for both in our healthcare. And while the allopathic side holds up scientific method and evidence as the oracle of their field, the CAM practitioners, with equal zeal, cite tradition, spirituality and mystery of the human body as the central dogma in theirs. And when each is subjected to a critical appraisal by the other's methods, failure is the most frequent, if not unexpected, result.

So what is the answer? Should allopathic medicine, the side that right now holds much greater power and sway over our healthcare system, let in these pseudo-scientific usurpers even without any scientific evidence that they do any good? Should the two just coexist side by side, much like suggested by Einstein and Gould for science and religion? Well, it's complicated.

It is hard to argue with a straight face that the earth is flat or that it is indeed only six thousand years old, given the plentiful fossil record to the contrary. Believing an ancient text verbatim and denying the reality of the evidence to the contrary is not only a logical fallacy, it betrays stupidity and petulance. Similarly, denying that uncontrolled hypertension is the cause of coronary disease is ridiculous. However, given the complexity of the organism, we know that it is not the only cause of coronary disease. Furthermore, there may be causes that we have not discovered yet because we have either not thought to look or are unable to discern because we do not yet have the necessary scientific tools. This is to say that we know a lot, but probably not everything.

Now, let's move on to treatment of hypertension. The way we establish whether a modality works is through randomized controlled trials, where we look for differences in outcome based on the differences in the main exposure, in our particular case, the treatment for hypertension. Randomization is meant to ensure that the two groups being compared are not different from one another in any systematic way, and we reassure ourselves that randomization worked by looking at aggregate physiologic measures of the two groups, such as average blood pressure, average age, etc, and seeing if they are the same in both groups. If they are roughly equivalent, we say that the randomization worked, and all the differences in the outcome we see must be due to the experimental intervention, in our case the blood pressure treatment.

But what are we unable to measure? Oh so much! The burgeoning science of neurobiology, for example, has raised so many interesting questions about not only what the mind can do to the body, but what the body can do to the mind (please forgive this dualistic language). Why is this important? Because, due to our lack of adequate tools until recently, and because of the overwhelming complexity of the subject, we have traditionally neglected to include any measures of our patients' and trial subjects' neurobiological milieu into the consideration of differences between groups. But if randomization takes care of other systematic differences, should it not take care of the neurobiological ones? Perhaps, but without understanding the magnitude of variability of these characteristics in a population, one cannot begin to know how large a swathe of the population has to be enrolled in a study in order to smooth out these potential differences. And this goes for other so far unknown or unidentifiable characteristics. So what we think we learn from these trials is, much like in any other branch of science, subject to interpretation within the context of our knowledge today, and is, therefore, far from the universal and immutable truth. And the more we learn, the less absurd certain heretical ideas of the past seem. It's OK, we are all in good company. Even Einstein was not infallible: when he said that "God does not play dice with the Universe", he was alluding to his skepticism with regard to randomness of quantum motion, which has since been confirmed.  

But I stray from my main question, which is "Is the dichotomy between allopathic medicine and CAM a false one?" Well, what if we broaden the argument. We know that a human being is a fairly complex animal. As I alluded to above, we are only now beginning to put the data from neurobiology behind the phenomena of the human condition that have been observed for millennia. Such human impulses as the need to be surrounded by nature, compassion and need for retribution are all gaining scientific underpinnings in neurobiological research. So, what we already knew and understood about ourselves is now being explained (the "how") by science. This is comforting, and it should make my evidence-based allopathic colleagues pleased. It should also please the CAM practitioners, as the traditional views of what it means to be human are being validated.

So, what am I driving at? Krista Tippett in the Introduction to her latest book Einstein's God says that "opinion polls create false dichotomies". Since we live in a time when polarization seems to be the norm (just look at our political discourse), it is natural for allopathic medicine and CAM to retreat more deeply into their own corners and to become more entrenched in and convinced of their own singularity. This is the wrong approach. Humans are not all easily-understood physiology, but we are also not all spirit and mystery. We are in fact both. Some of the conditions we define as physiologic illnesses are nothing more that the products of our distorted expectations and philosophies. Some of our impulses to treat cancer with CAM alone are misinformed. If acupuncture seems to help my neighbor with her subjective symptoms of menopause, so be it, I am happy for her, even if I do not fully understand how it works. If yoga gives me a sense of well-being, yet there are no randomized controlled trials to validate this assertion, so what? Perhaps more "N of 1" trials are the way to go for CAM, I don't know. But I do think there is something to the subjective experience, even if we call it placebo effect, which incidentally implies that it is your own organism, with the help of an external stimulus, that has achieved the desired end. Why is this bad? Especially if there is no adverse consequence to counterbalance it? Granted, we have to be conscious of the attendant costs in this mammoth healthcare system of ours. Well, I for one am not averse to subsidizing my neighbors' well-being, even if the science tells me the effect is no different from a placebo. We already pay a premium dollar for interventions that only seem to work in a small minority of individuals who qualify for them based on well-accepted scientific evidence. And this is not even getting into the discussion of how much adverse reactions cost, even when there is no individual benefit of treatment.

It is true that science sets a high bar for gathering evidence. But one must acknowledge the inherent subjectivity in how we define endpoints of importance, and a complete antithesis to clinical sensibility of pursuing the p value. Medicine is and will remain inexact, part science, part art. To hold these two seemingly different philosophies together does not present an internal conflict for anyone, just as holding the methods, aims and philosophies of allopathic practice and CAM should not. Bridging these as nonoverlapping magisteria in healthcare can eliminate much of the conflict felt by the medical profession, and promote a more open-minded and humanistic approach to our public's health.                              

    

   

Requiem for my father

My father passed away about two weeks ago after battling a brain tumor for some time. Initially diagnosed with an extensive inoperable mass one and one-half years ago, upon presenting with a focal seizure, he did well with only one medication for seizure control for about ten months. Around Christmas of 2009, however, he landed in the hospital in status epilepticus that took three days to control. After these days of florid hallucinations alternating with pharmacologically achieved stupor, he came out of it remarkably cognitively intact, still able to quote poetry and sing Italian opera arias in their entirety. Although he was now unable to use his legs, he eagerly accepted the prospect of getting back on his feet by working hard in physical therapy. And though this never came to be, he managed to survive for additional seven months.

But my Dad was not your average guy. A survivor of World War II, an immigrant from the Soviet Union, a retired professor of mechanical engineering, he was at once a brilliant and an infuriating man. His stubbornness knew no bounds, and, even though he did not have the affinity for competitive sports, his drive to win was strong. He was a survivor by his nature and by his experience. So, when he was faced with the choice of a rapid decline and death versus some form of treatment for his tumor, he opted for the latter. As he and my mother put it, "doing nothing was not an option". So, when offered 6 weeks of radiation (5 days/week, with the risk of cognitive decline, the prospect of which terrified him as much as dying) together with oral and intravenous chemotherapy, he bravely accepted all.

As the days and the weeks of his treatment wore on, he would give me regular updates on how many radiation sessions he had completed and how many were still left to go. He suffered side effects with minimal complaining and never lost hope that the treatment would help him achieve a measure of meaningful recovery. This was not to be.

While I accompanied my parents to many of his appointments, I did not go to them all. And for this reason, I cannot say for sure what was said in some of them, and how different the content might have been from what they actually heard. But I did make the point of talking to every one of the specialists on the phone after they saw my father. They were all appropriately measured in their enthusiasm and recommendations while talking with me. But did they have the same demeanor with my family? Did my parents, both highly educated but neither medically savvy, take their enthusiasm for palliation as a promise of a cure? More importantly, are similar offers to try to prolong life by well-meaning and compassionate physicians to their desperate patients routinely misinterpreted on a grand scale by thousands as promises of cure? Is it possible that most people accepting the wonders of Avastin and other high tech interventions do not really internalize the reality that this and similar wonder drugs may give them merely two months of additional life? And further, do they think that these added months will be "normal" life?

Well, in my father's case, he got superb care at every institution he went to. His doctors and nurses were knowledgeable, compassionate, humane; in other words they were everything that healthcare professionals should be. Yet their eagerness to help a desperate and scared man may have inadvertently registered as false hope for results that were unlikely. My father tolerated his treatments, but over time began to exhibit cognitive decline, at first subtle, then more pronounced and made exquisitely more painful by his over-achiever baseline. He eventually succumbed to aspiration pneumonia after we made the painful decision to provide him with comfort care only.

After seven months of this most intense good bye, my mother now understands end-of-life issues better than many healthcare professionals. She is a seasoned and experienced decision-maker in a grave situation. But this experience comes at a steep price and a little too late, since I hope she is never faced with having to apply it again to a highly personal situation. She will not regret any of the choices that she and my Dad made in this journey -- they were all correct for them. But I have once again to question the wisdom and utility of making available treatments that make a difference at the slightest of the margins, that cost the society enormous resources and exact such high emotional costs from patients and their families.

Death is a natural conclusion to a life. Since we are not that good at "just sitting there", the vocabulary of "do nothing" needs to change to "helping patients die with dignity and comfort". The manipulative rhetoric of "death panels" has to be replaced with empathy and compassion. We are not above the laws of the Universe, we are not above the laws of physics and biology. We have to reposition our societal attitude toward death as an avoidable nuisance. And we have to ask: what are we prolonging in many of the cases that we treat at the end of life -- life or death? In his better days, my Dad might have asked an analogous question: are we living longer or does it just seem longer? And then he would have chuckled. Rest in peace, Dad.                        

Microbiome: passenger or vehicle?

Remember how you learned in BIO 101 that many fluids in the human body are normally sterile? And you know how you laugh with condescension when someone dares to question this dogma? After all, we know that the gut and the skin are full of microorganisms, but the lung? The bladder? This is inconceivable, heretical!

Well, actually, this, like many other dogmas that seemed like God's word at the time, has been broken open by some very interesting research emerging from multiple laboratories around the world. I was first stopped in my tracks about a year ago, while listening to an NPR story in my car and learning that the number of bugs we carried on and in us was about 10-times greater than the number of our own cells. Then, in a farm house in Cornwall a couple of weeks ago, while on vacation, I read an article in an October 2009 issue of Eureka, The Times monthly science magazine, which once again made me ponder our sojourns in life, the bacteria that cohabitate with us. And finally, today I saw this story in yesterday's NYT, which galvanized me into writing action. This grabbed me in particular:

Scientists are even discovering ecosystems in our bodies where they weren’t supposed to exist. Lungs have traditionally been considered to be sterile because microbiologists have never been able to rear microbes from them. A team of scientists at Imperial College London recently went hunting for DNA instead. Analyzing lung samples from healthy volunteers, they discovered 128 species of bacteria. Every square centimeter of our lungs is home to 2,000 microbes.

It grabbed me for two reasons:
1). I am a lung doctor, and a lot of the research that I do centers around lung infections. One type of this infection, ventilator-associated pneumonia or VAP, is the subject of much scrutiny by policy makers and payers, and is emerging as a quality indicator. There are many challenging issue in VAP, not the least of which is its treatment: because it is likely to be caused by an antibiotic resistant organism, and because at least one-half of all cases of suspected VAP never grows out a specific microbe, the recommended empiric treatment is with broad-spectrum drugs. The clinician treads a fine line between undertreating the patient at the expense of increased mortality or overtreating and promoting antibiotic resistance.
2). I have already written here about my thoughts on evidence and how we tend to approach our knowledge with the arrogance that blinds us to the possibility of being either under-informed or plain wrong. Well, here is the case where we were so convinced of what we knew, yet it was plain wrong! With the scientific skepticism and appropriate tools we are learning something completely opposite to what we thought we knew.

Taking this line of thinking one step further, can we now conceive of the possibility that what we expose our bodies to actually plays a role in our long-term health? To be specific, I mean something as simple as food and the way our food is produced. Monoculture and food engineering have become staples of our food production. Animals are raised in CAFOs in conditions requiring them to be on antibiotics to ward off infections and to help with growth. Additionally, to leverage the subsidized and abundant corn supply, food animals are forced into diets completely unnatural to them. Cows, for example, evolved over millennia to be ruminants meant to eat grass and hay, are fed a corn-based grain diet, which, by altering their gut environment, makes them much more likely to carry toxigenic E. coli. Although there is much nay-saying about whether antibiotics (and hormones, by the way), are passed on to humans through meat or milk, I have never seen any convincing scientific evidence to the contrary. So, if we eat meat that is microbiologically altered, and may also be exposed to antimicrobial residues that may in turn change our own native microbiome, is it possible that at least some of the emerging health issues are due to the travesty of monoculture production?

I am not saying that I have all the answers -- clearly, this research has a long way to go to establish causal pathways and potential points of intervention. But let's exercise our common sense and at least ask the questions. Do it early and often. And let's please agree that there is a certain burden of proof here that resides with the food production oligopoly. Oh, yeah, and let's not forget to continue limiting the use of antibiotics in human health too. And have a little bit of dirt... for lunch... every day...  

How much for your vote, Senator?

It is not a secret that large sums of money have passed from the pharmaceutical and device manufacturers into physicians' hands. This money has been paid not only for such socially beneficial pursuits as research and consulting, but also for lavish gifts and junkets. And interestingly, despite disingenuous assertions to the contrary by many a stake holder, these gifts generated a return on investment -- surprise! It turns out that the spender companies could count on improving their prescription volumes in return for their magnanimity. Well, of course this is really no surprise. After all, we all know that money talks. What has been less clear over the years is whether small, almost inconsequential gifts, might also be influential in changing practices. Social sciences provided us with an answer to this: even gifts of small value create fertile soil for payback. OK, then, the answer became clear: remove all manufacturer influence from the day-to-day world of medicine. And so it has happened that pharmaceutical reps are no longer allowed to bring lunch or pens or pads of paper with the name of their wares on them to the hospitals or offices. Only educational gifts of a certain value are accepted. I will refrain from opining on the journals' and professional societies self-absolution from such rules, as my views on that are beyond the scope of the current post.

Is this removal of potential temptation bad? For someone who can argue each side with equal aplomb, the question is irrelevant: it just is. What interests me a lot more is this: how is it that a 25-cent pen can sway my brethren's prescribing practices, but $1 million in campaign contributions leaves a politician impartial to the contributor's cause? Take Senator Lieberman's claim that $1 million in campaign contributions from the health insurance lobby has not affected how he votes. See for yourselves, in this NYT piece from December 2009:

Campaign finance advocates have attacked Mr. Lieberman as “an insurance industry puppet,” suggesting that he wants to protect private health insurers from competition because he has received more than $1 million insurance company campaign contributions since 1998.

During his 2006 re-election campaign, Mr. Lieberman ranked second in the Senate in insurance industry contributions. Connecticut is a hub of the insurance business, with about 22,000 jobs specifically in health insurance, according to an industry trade group.

In the interview, Mr. Lieberman dismissed assertions that he was doing the industry’s bidding. “It’s hogwash and it’s weak,” he said, noting that he had often sided against the companies. 

Are we really supposed to believe that? What about Blanche Lincoln, when she asserts that $1/2 million in oil money that her campaign has taken has not swayed her legislative priorities, is she for real?

A spokesperson for the Lincoln campaign says that campaign contributions play no role in the senator's public policy decisions.

"This ad is nothing new, just more lies from another outside group seeking to malign Sen. Lincoln's record and bully voters into their agenda," spokeswoman Katie Laning Niebaum told CBS News. 

If a 25-cent pen can hijack a doctor's prescribing practice, how can these sums of money not be hijacking our democracy? And upon whom does the burden of proof fall in this situation?

Here is my solution: less advertising, less mud slinging, less dirty money (a.k.a. special interest contributions). Naïve? Maybe. But totally necessary. Let's do what medicine has done and, a-la Nancy Reagan's advice, "Just say 'NO'!" It's time to bring back our democracy!

Dear Dr. Val

Dear Dr. Val,

I enjoy reading your blog and the contributions from many of the leading medical bloggers that appear on it. Occasionally, the spirit moves me to post a comment, but for the second time in just a few months my comment has not made it to your blog. Why? I also tweeted you to ask if there are technical difficulties peculiar to my comments, but I did not get a reply. Why?

I know that some bloggers have a policy about what comments get rejected. I know that I will not accept abusive, profane or overtly marketing comments on my blog. I am sure you have the same standards. So, why not accept mine? I read Dr. Novella's post with great interest yesterday, and got passionate enough to write a pretty lengthy response. I am grateful to you and to Dr. Novella for allowing me to think through some of the issues that I commented on. But I was hoping for a dialogue... How will we ever arrive at mutual understanding or even better individual understanding without a cogent dialogue?

I do understand that the blog belongs to you, and you must have many reasons not to accept all comments, and that is your right. Perhaps you never even saw it, perhaps you no longer follow my tweets and thus did not get my queries. That is all fine. If I cannot get my comment on your blog next to the corresponding post, I will put it here and hope that you will come for a visit. If you do, I will welcome your comments. So, here it is:

What a great post! Dr. Novella makes the point that there is no evidence for the superiority of consuming organically produced foods over the conventionally produced ones in terms of health benefits. To arrive at this conclusion he relies heavily on a recent systematic review supported by the UK Food Standards Agency, which examined 12 studies, 8 of them in humans, 6 of which were RCTs and the remaining 2 observational studies. Because the article is available by subscription only, I could not access the whole paper. However, knowing what conducting clinical trials entails, I doubt that the 6 experimental studies followed the subjects for all that long. Perhaps not long enough to detect the benefit? Would love Dr. Novella to comment on this.

Additionally, divorcing the potential direct health effects due to consumption of organic products from the effects of the production on the environment is a false dichotomy. The pesticides do not just stay on the skin of the produce, but get into our water supply; the antibiotics given to the animals in CAFOs do not just get into their meat, but also get into the water and produce resistant pathogens -- there is plenty of work from the Netherlands to support the connection between agribusiness practices and human pathogen resistance emergence. Also, look at the staggering findings by the USGS about the contaminants found widely in our water supply and in what amounts.

The monoculture model of conventional agribusiness also requires enormous amounts of petroleum for fertilizers and pesticides as well, a resource that is dwindling. And, perhaps most importantly, the impact of monoculture farming on the land itself is devastating, decimating arable lands and creating essentially sterile deserts which need centuries to recover.

Having said all this, the mass-produced organic food business is not much more environmentally friendly than the conventional agribusiness, relying on monocultures and artificial fertilizing and pesticide management, as Dr. Novella aptly points out. Additionally, because it is concentrated in places remote from where it is consumed, its carbon footprint is still enormous. The really sustainable way to farm and eat, environmentally and human health-wise, is returning to small local farming, with a short distance from farm to table and a self-perpetuating cycle of earth's nutrient consumption and repletion by a diverse biome, just like nature intended.

My final sentiment is that, as people involved in healthcare of our nation, we must care about social and environmental justice. While these issues may fall more comfortably under the rubric of Public Health, doctors and nurses and other personnel at the bedside need to develop a greater appreciation for the context in which disease develops. This context includes healthy and sustainable food production and other social and environmental concerns.

  

When do tests improve mortality? A confusion worth clearing

This is a question well worth asking, particularly as we argue about the merits of mammography screening. The USPSTF has really stirred up the hornet's nest with this one, and the politicians cannot help but get on their populist pulpit, ignoring the facts completely. Oh well, what else is new?

But the question remains: do screening or diagnostic tests that are more sensitive save lives? A great talk on pulmonary embolism detection and outcomes by a recent graduate from the Dartmouth group at the American Thoracic Society last week prompted me to clarify this. We all hear that mortality from many diseases has decreased over the last few decades. But is this true? In order to answer this question, one has to ask what is meant by mortality. Even people well versed in epidemiology and biostatistics occasionally blur the lines between mortality and case fatality, and to our question the distinction is critical. Case fatality is defined as the proportion of patients with the disease that dies, while mortality is a population-based measure, a proportion of all of the population at risk for the disease that dies. The difference lies in our old friend the denominator, which will always keep us honest.

Let's go through a simple example to illustrate this concept. Let's pretend that the total number of cases of disease D diagnosed using stone-age test T 30 years ago was 100 in a population of 10,000 people. Of these cases, 90 died, giving us the case fatality of 90% and mortality of 9 per 1,000 population. Now, we have a new test for D, a super-Doppler-MRI-PET-cyberscan called über-T, a much more sensitive test than the old "gold standard" test T. And now we detect 1,000 cases of D in the population of 10,000 people. Of the 1,000 cases detected by über-T, 90 have died. The case fatality now has decreased dramatically from 90% to 9%, and we can pat ourselves on the back for a job well done, right? Not so fast, the population mortality from disease D has remained a steady 9 per 1,000 population!

So, what does this mean? Does it mean that über-T, which costs 2 orders of magnitude more than its predecessor, is worthless? Well, decide for yourselves. What it means to me is that the additional cases detected by über-T, though finding earlier stage disease, thus increasing the denominator for the case-fatality calculation, has had no impact on the numerator and therefore has not in fact improved the only mortality that matters: population mortality related to the disease.

So, next time a politician tells you how well we are doing with technological innovation in disease management, ask this simple question: Has all the money and innovation really altered the important outcomes, or is this all smoke in mirrors, a mirage created by our irrational belief that technology is our salvation? This may be an uncomfortable epiphany for some. But think about the 900 excess cases of the pseudo-disease diagnosed in our example above -- how many people could have been saved becoming a chronically ill person, how many complications of follow-up procedures could have been avoided, and yes, how much money could have been spent on something other than healthcare? And asking these questions may help us to identify technological advances that actually improve our lives, as opposed to those that merely create attractive business opportunities and stimulate the economy.          

Is synthetic happiness authentic?

Dan Gilbert asks, Why are we happy?

TED talk from 2004

I am preparing a talk on REMS (Risk Evaluation and Mitigation Strategies) that I will be giving in Philadelphia next week. Instead of my initial thought to present definitions and case studies, I decided to talk about risk perception, evolutionary reasons for it, and the ethics of risk mitigation. In chasing some of the sources for facts and factoids, I came upon this fascinating talk. Enjoy! 

Oh, and check out minute 9...

Nancy Etcoff's TED 2004 talk on happiness vs. absence of misery -- also awesome! She makes a great argument for synthesizing happiness.

Health, art and libraries: more in common than meets the eye

Our grandparents used to tell us, "if it ain't broke, don't fix it". Management gurus, in their race to the Finish line (and what a Finish line it will be!) have turned this sentiment on its head by telling us that, if it ain't broke now, it will be soon, and if you do not fix it before it breaks, you will be behind the competition. This sentiment drives the annual corporate reorganization at every corporation that I or any of my friends has worked at, and puts millions of dollars into these gurus' bank accounts. 

Politicians have adopted this philosophy as well, to much detriment to the citizens. I live in the rural and much neglected Western part of the state of Massachusetts. We like being neglected by the State House in Boston; we are used to it and we like it. What we do NOT like is paying disproportionate taxes for fewer services than our friends East of I-495 get. One pearl of our Western MA civic life is our libraries: they are so much more than a place to get a book. They are community centers, places for people to meet and discuss current events, for local poets and artists to show their wares, for children to learn the responsibility of civic engagement through volunteering. In the economic downturn, where else can an unemployed person find employment and training resources for free? Where else can someone without access to the internet come and use a computer without spending $4 on a cup of coffee? Libraries are what makes our communities what they are. So, how ironic is it that the MA Library system, the very system that is working remarkably well on a shoe-string budget, is under the damocles sword in the budget planning process? The very system that ain't broke is about to get quite a fix. And we, the citizens along with it.

So, you ask, what does this have to do with healthcare or health? A lot! Personally, I am sick of ever-increasing taxes buying ever-decreasing services. Yes, there is inflation, and what a convenient excuse! This all falls for me in the same bucket as the travesty of our educational system, our healthcare system, and, in general, the quackery of the trickle-down economic theory. 

Let's take education. The first things to be cut perennially are arts and gym. What does this do? A lot! Do we really think that the obesity epidemic is somehow not related to devaluing physical activity in the schools? Of course it is, and I do not need a randomized controlled trial, or even a cohort study, to recognize this. Do we really think that art is not an essential component of educational foundation? Just because it will not lend you a corporate job in the future does not mean that it is unimportant. And schools are but a sample of the society at large. Look where we are as a nation: addicted to consumption of trash, creation of trash, assimilation of trash. We are more miserable and demoralized than we have ever been before, we work harder than ever before for less money than ever before, and we pray to the god of the free market more ardently than our ancestors prayed to the god of rain ever before. We have created more disease than we had ever thought possible, and along with it a $2-trillion godzilla of a healthcare "system", only too happy to treat anything and everything under the sun. Like an out-of-control cartoon bulldozer, we are razing our earth, our children's future and our own sanity. 

Of course, I am not saying that all of these ills can be fixed by reintroducing art and phys ed back to our schools, but it sure would be a start. But, indeed, we have been manipulated, duped, sold a bill of goods, taken for a ride! Our market-focused utilitarianism as the single raison d'etre has brought us here, and it has to go; we need to find our way out of this spiritual isolationism and regain our sense of community. It is absolutely an issue of health! Nurses, physicians and other healthcare providers, I call on you to start addressing the civic health of our communities. Get involved in your local politics, and not just because you are interested in maximizing your Medicare reimbursements. The time to act is now. You can start at your local library: have a discussion about how to maintain and improve your community's health, physical, mental and spiritual. It may not be fiscally expedient. But most important stuff in life never is.                     

Earth day healthcare

This post is a continuation of the series looking at the cross-roads of peak oil and healthcare.


Happy anniversary of Lenin's birth, everyone! Yes, the Communist Revolution's leader was born on this day in 1870!

But much more seriously and importantly, happy Earth Day! No matter how cynical you may be about what this day has turned into, you can personally take this time to reflect on your interaction with our Mother. The Buddha felt that we are not distinct from anything, including the earth and the rest of the Universe. So, if you are an intermediate-to-advanced Buddhist, this is a good day to practice oneness. For the rest of us, perhaps we can engage our thoughts to be mindful and notice throughout our day how our actions impact the environment.

And this, as everything does eventually, brings me to healthcare. As I mentioned in my recent post, healthcare system is a tremendously heavy consumer of our natural resources and, as a result, a huge producer of the greenhouse gases. "But it is all in the name of health", you say! Is it really? Dig deep down and ask yourself why you ordered that EKG on the perfectly healthy asymptomatic guy who is starting an exercise regimen, or why you got an MRI for that chronic low back pain? "But look at the strides we have made diagnosing and curing disease", you say! Is this progress not a fair trade-off for the little energy expenditure and a slightly enlarged carbon footprint?

OK, so I have a couple of problems with this argument. First of all, some people would say that the vast majority of the strides we have made in health and longevity are due to such public health interventions as water and sewage treatment, municipal solid waste removal, and the advent of antibiotics. Most of the progress we are making today comes in minute increments at the cost of not only exorbitant dollar amounts, but also of the environmental resources. Not only does this "innovation" require an input of energy and materials, but the waste that its development and manufacturing produces can be staggering, counting not only the green house gas emissions, but also the garbage it yields on the back end. Similarly, the utilization of so much technological "advancement" requires materials, energy, as well as the means of waste disposal. And just because once the trash is hauled away we do not see it does not mean that there is no environmental toll from it.

At this time of healthcare reform, we as a nation are beginning to ask some questions previously regarded as heresy: Are the effects of this intervention worth the healthcare dollars spent on it? I believe that we must go way upstream from the technology being in use on the market, and must start factoring in the environmental toll of its evolution from the genesis of the idea itself. Only this way can we understand the true worth of what we are proposing to use in the name of healthcare.

I know that for most of us to feel one with the world around us is not feasible or desired at this moment. So if chanting Om does not unite us the Universe even for a moment, let us use our well developed minds. The resources of this earth are finite. And even it you do not believe in climate change (though it is difficult for me to imagine how one can believe in God and yet not see the verity of the science behind global warming), perhaps you can start to cultivate a little doubt in your conviction that we can continue as we are with impunity. Perhaps by using our resources mindfully, by asking ourselves several times whether opening that extra needle or ordering that extra head CT is really necessary prior to plunging into action, we can not only forestall the impending oil and climate crises, but also develop a closer relationship with the planet that is ours and our children's home.        

     

Imagining post-peak oil healthcare

This post is the first in a series that will examine some ideas on the potential impact of peak oil on healthcare, as well as some solutions for meeting this change in a prepared way. 

As you all know, I do believe in the peak oil theory. Think about it: in a closed system nothing is infinite. Since oil is a product of millions of years of decay, unless we use it at the same rate that is it produced, we will run out. I do not have a crystal ball any more than anyone else I know, so I will not hang my hat on when, but will commit to whether: yes, it will happen. And while a lot of people have conjectured about what the world will look like post-peak oil, there is a surprising paucity of hypotheses or suggestions about healthcare. So, I will try to use my imagination to start to fill this gap.

First, a few facts.
Fact 1: The world, including the healthcare system, runs on cheap oil. The world's daily use is 80 million barrels, 20 million barrels of which is used in the US, and 70% of those 20 million goes to the transportation sector.
Fact 2: The healthcare sector is a super-user of energy. The US Department of Energy estimates that

...hospitals use 836 trillion BTUs of energy annually and have more than 2.5 times the energy intensity and carbon dioxide emissions of commercial office buildings, producing more than 30 pounds of CO2 emissions per square foot.

As we know, hospitals are incredibly technology-heavy institutions. In addition, literally tons of medicines and plastic disposables made from petroleum are the cornerstone of our healthcare model.
Fact 3: There is no imminent technological solution for the impending oil shortage.

Now, why should you take my predictions of such doom and gloom seriously? Well, for one I am not prophesying doom and gloom. Rather, since forewarned is forearmed, I am reiterating a warning still with time enough for us to start preparing for a different way of life. You don't believe me that it is coming? Do you believe the US military? Their recent report clearly points to a drop in production and impending shortages of oil. They ought to know, being the biggest global consumer of this resource!

But back to medicine. What will it look like post-peak oil? I am happy to say that you still do not have to trust me, but perhaps Howard Frumkin's of the CDC thoughts on this topic (subscription required) in JAMA can make you scratch your heads a bit:

Petroleum scarcity will affect the health system in at least 4 ways: through effects on medical supplies and equipment, transportation, energy generation, and food production.

It is worth reading the entire editorial to get the flavor for what is likely to come. At the same time, one can easily engage one's not too wild imagination to start visualizing the situation. Taking it item by item, medical supplies and equipment are not only manufactured from or with petroleum, but they need oil to get to our hospitals and to run. Transportation needs very little explanation, given our reliance on emergency transportation by such modalities as ambulances and helicopters, as well as the need for regional and national referral centers based on expertise and availability of services. Frumkin does a nice job talking about energy generation, and the concern here is an increased reliance on coal with its propensity for green house gas emissions, and so on, and so on. Finally, our industrial food production, having moved away from local integrated traditional farming to monocultures supported by automation which runs on oil, relies on additional oil for pesticides and fertilizers and transportation from the farm to the table.

So, what will medicine be like under these circumstances? The reality is that, if we as communities fail to prepare for this change gradually, we will be hit with it abruptly, and, you have to admit that sudden and unplanned changes are tougher to deal with than anticipated ones. I myself do not have all the answers, but I would like to challenge everyone, clinicians, administrators, patients and public alike, to begin this conversation. It would behoove us all to keep this idea in the backs of our minds as we move through our days, so that we can mindfully note what changes have to be made and what infrastructures need to be built to optimize our collective future.

Your participation in this discussion and comments with specific solutions will be greatly appreciated.

        

      

  

What's in a name or the furor over the proposed PA name change

Much like many other news items, I came upon the one about the proposed name change for Physician Assistants quite by accident: it came to me as an e-mail notification of a new topic being discussed on one of the physician only discussion boards that I am a part of. Apparently, after 40+ years of the profession's existence, there is a grassroots effort afoot to upgrade the name, and presumably the clout, to Physician Associate.

Well, as you can imagine, while the move is met with praise by the PA profession, the MD profession is seething. Some of the comments that I have seen from my colleagues betray such tremendous pain and suffering as a profession that it threatens my equanimity: I feel organically how lost we are as a profession to be expressing such bile without much thought over what appears to be a relatively innocuous event. But surprised I am not, and here is why. The medical profession's victory over all other potential modalities is hard-won and filled with a history of major turf battles and occasional demagoguery. The historically either-or approach of modern-day practice of medicine is responsible for the current landscape of our healthcare. In short, physicians have been only too successful at becoming the final word in health, at the exclusion of all others. With the allied providers, such as nurse practitioners and PAs, gaining in importance, particularly at this time of great uncertainty about the future of our healthcare "system",  understandably the MDs are reflexively bracing themselves for any and all turf battles. So, the perception of a power grab that this proposed name change has engendered in my hallowed profession is a classic fight-or-flight response, an activation of the survival instinct.

There are several aspects of this response that I find disturbing. At the most basic level, the response betrays such tremendous emotional pain among so many good people that it is all I can do to keep myself from sinking into a depression. And while I feel compassion for them, I am also forced to remind them that, as Eleanor Roosevelt once said, "No one can make you feel inferior without your consent". Applying the thought to the current situation, how the society may view PAs, whether they are called assistants or associates, should have absolutely no bearing on how physicians are perceived. Simply put, this perceived elevation in the status of the PAs relative to that of the MDs should not in any way make the MD profession diminish in its or the public's view.

The next layer of why this is a dysfunctional response lies in a poor choice of battles that this represents. I once had a boss, whom, despite working for myself currently, I frequently allude to as "the best boss I have ever had". When I would get hot under the collar, she would pointedly ask me to clarify for myself whether this was an issue to fall on my dagger for, thus teaching me that falling on my dagger too many times would make me politically into Swiss cheese, or, worse yet, dead. Under the circumstances, do MDs and their organizations really feel that this is an important dagger to fall on? In the current atmosphere of public distrust rightly or wrongly bestowed upon the profession, such indiscriminate issue picking will rightfully appear self-serving.

Finally, for a profession with, on average, a very high intelligence quotient, I am amazed that we are focusing on the minutia instead of looking at the big picture. Healthcare is a behemoth, an inefficient and inequitable trough at which there has been a feeding frenzy for too long. We need to be reining it in to the best of our abilities. And yes, altruism, not unmitigated self-interest should be driving us to do this. Gentleness toward and respect for each other, our communities and our planet should be the values that determine our actions as a profession. I am convinced that these are the values that brought us into medicine.

These are difficult times, made more so by the external forces all ganging up to deprive us of our humanity. Let's get back to the reasons why we went into medicine; let's sit quietly and find that lost thread of contentment and pride. Or else, if there is no joy left for you in your practice, resolve to find something else that you can be happy about. And no, it is not easier said than done. It is much more difficult to go through life carrying the baggage of self-imposed misery than to set it down in favor of finding happiness in this brief sojourn that is our life.                

Evidence: What the bleep do we really know?

So I know that my blogging has fallen off a bit, and I am sure you are all sorely disappointed (or not). Let me try to explain why.

There are several things going on to nudge me toward the next rung in the evolution of my thinking about healthcare and evidence. The event most responsible for this re-examination of my assumptions is the previously-mentioned illness of a loved one, along with my need to be closely involved with his care decisions. I think that I have generally adequately voiced my frustration with how decisions are made in our healthcare system, and where the switches for these choices should be as opposed to where they are. I am even more convinced now that by the time the physician and the family are considering expensive options with marginal effectiveness, the cat is already out of the bag: how can either the distraught family or the committed healthcare provider not consider those, despite shaky evidence of the value?

But this is not all. I have actually been cogitating the entire way we do evidence and evidence-based medicine. When we invoke evidence, we generally talk about some scientific study's findings, or a group of studies either showing similar or differing results. Let's keep stepping back and looking at the components. The scientific community, based on some statistical and other methodological considerations has come to a consensus around what constitutes valid study designs. This consensus is based on a profound understanding of the tools available to us to answer the questions at hand. The key concept here is that of "available tools". As new tools become available, we introduce them into our research armamentarium to go deeper and further. What we need to appreciate, however, is that "deeper" and "further" are directional words: they imply the same direction as before, only beyond the current stopping point. This is a natural way for us to think, since even our tools are built on the foundation of what has been used previously.

So, what emerges is a picture of being emotionally committed to a certain way of viewing the question, the processes of answering it and the actual answers. And what if by narrowing ourselves to this one particular way of examining the world, to this one particular way to collect and interpret the evidence, we have effectively ignored all other possibilities?

Let me try to clarify what I mean a little further. We spend our days walking through waves. Some of these waves we can detect through our own senses: sound, light, for example. Others we need special external "receptors" to detect, such as radio and micro-waves. Is it possible that there are some other, heretofore unknown waves (or other phenomena) that are around us that we are unable to attune to because of our biology? Is it kooky to think that this is possible, or is it simply blind to walk away from such possibility?

The answer may be that it is both. Nevertheless, it is highly likely that there are many biological phenomena that are not amenable to being examined through our narrow prism of current methodology. We as scientists and clinicians need to be open to this possibility. The Buddha said that both preachers and scholars are blind because they constantly commit themselves to partially-seen truths. Given the shambles in which we find not only our nation's healthcare system, but also the health of its citizens, this would be a great time for this epiphany to penetrate our collective psyche and strive toward a broader view of possibilities. Let's give up the arrogance of ignorance in favor of the humbleness of enlightenment.

And these are my latest thoughts. I am not saying that they are the only way or that they are even remotely correct. But here they are nevertheless. Do with them what you will.