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.            

Stupak shtup

Did Stupak finally shtup himself instead of millions of poor Americans, as he had intended to? I think so, and with the Catholic nuns, no less. The man who has been living up to his unfortunate name by trying to derail the healthcare bill because of the non-existent threat of public money funding abortions is now turning on himself, apparently. In a MSNBC interview, as reported here in the NYT, he evidently disparaged the importance of a large and influential group:

"With all due respect to the nuns, when I deal or am working on right-to-life issues, we don’t call the nuns."

Can we hear this again? You don't call the nuns?!!! I think what he meant to say is that we don't call on WOMEN! I for one, though not Catholic, am taking this very personally. I truly believe that it has to do with disparaging the opinions of those who do not hold economic power, particularly the poor women of our nation. "We do not need to listen to them because they are not the ones electing us" is the implication of this stupid stupid remark.

Well, Bart, I do hope that you enjoy the self-stupping that this represents. With this remark, more than any other in the previous few weeks or months, you have shown your true colors. Go back to where you came from and enjoy the fall-out!

Lies, big lies and... epidemiology?

Now, as you know, I am a big fan of epidemiology. I do not believe that a randomized controlled trial is the be-all-and-end-all in evidence generation, and a well done observational study can add to our reservoir of knowledge much more efficiently. Of course, I, as many others, acknowledge certain limitations of epidemiologic design. However, many of them can be overcome with careful design and analysis.

I have to confess, though, that over the last week I have bumped into two news stories that have made me cringe. The first, reported a couple of days ago and based on a Kaiser study, showed that people

drinking at least four cups of coffee a day were 18 percent less likely to be admitted with a heart rhythm disturbance than those who drank no coffee at all.

So, great, the public may take away the message that drinking coffee prevents a-fib. Well, I have to say that the reporting of this was measured and tried to avoid this unfortunate inference of causality. Yet, it left enough room to imply that yes, perhaps there is a causal link. So, what's wrong with that?

Bear with me while I bring in the second example of a study that bugged me this week, based on the Women's Health Initiative. You may recall that the WHI is the large NIH-sponsored study that a few years ago turned hormone replacement therapy on its head. The study had a randomized component and an observational component. So, the newest analysis shows that women

who drank the equivalent of one to two drinks a day -- be it beer, wine, or liquor -- were 30% less likely than non-drinkers to become overweight or obese.

 Do you see the similarities? So why am I bothered? To me this is the classic case of a high potential for confounding by indication. What's that you say? That is a situation in which a subject that has the exposure in question (in these two cases coffee and alcohol) is inherently different from one who does not, and this difference is what determines the probability of the exposure itself. Why should this present a problem in a study where the authors carefully adjusted for confounding, which is true for both of the studies? It is a problem because the kind of confounding that this represents is impossible to tease out without real-time attention to the subject.

Here is how it would work in the case of coffee study. Say I am a person with paroxysmal (occasional) a-fib, and I have noticed that if I drink so many cups of coffee per day, I get into brief episodes of palpitations. Not enough to send me to the doctor's office or the hospital, but enough to start thinking about cutting out caffeine. So, I stop drinking caffeine, and continue with my baseline frequency of a-fib attacks. You see the problem? Is it possible (or even probable) that those people who drink four or more cups of coffee per day somehow have an inherently higher threshold for slipping into their a-fib than those who do not? And if the answer is "yes", then the four cups become a marker for someone who can tolerate them, rather than the cure for a-fib. You can construct a similar explanation with the two drinks and weight.

So, while I love epidemiology and its methods, I am wary of hanging my hat on associations that may likely be explained by confounding by indication. And although the stories were reported with many caveats, human nature may prevent us from hearing the nuance. It is clear that in both these instances the burden of proof is on the researchers to show me that I am wrong.      

 

  

Republican healthcare paradox

Reading the transcript in the WSJ of the remarks at the President's Healthcare Summit by Paul Ryan, the ranking Republican on the House Budget Committee reminded me of an occasional altercation during my childhood. When a friend would break a favorite toy, the temptation was to ask for the impossible: I want it back exactly the way it was, right now! Over the years this kind of a debating style thankfully dwindled in favor of more reasonable and logical solutions. How is it that our political discourse has spiraled into the childish domain of the unreasonable?

Here is the disconnect: on the one hand, as Mr. Ryan points out, the Obama-supported healthcare bills may bend the cost curve in the wrong direction, increasing drastically the deficits and creating empty promises for the future generations. This is clearly undesirable. But where was Mr. Ryan when Sarah, Michelle and the tea baggers were crying "death panels" and government sanctioned euthanasia when the talk came around to curbing the potentially unnecessary and marginally effective care that ravages our healthcare system? How can we have it both ways? Is it not obvious that if tthe amount of healthcare delivery continues its upward trajectory, the bill accompanying it can do nothing but continue to go up as well?

The Republicans insist that they merely object to governmental intervention in the healthcare market, and they would be delighted to craft legislation that promotes free market solutions to this mammoth that is killing America. Really? When was the last time any congressional legislation promoting "free markets" helped the people who are struggling? If the fact that in 2004 the top 0.01% of the US population controlled 6% of the nation's wealth is any reflection of the success of such legislative efforts, well...

This spin machine has got to stop. We need to demand that our legislators speak honestly and rationally about this complex multifaceted issue. The reality is that all Americans need to do some soul-searching in order to make the adult decisions that need to be made. What are we willing to give up and what are the trade-offs we are willing to accept? As difficult and as unusual it is for us to think of giving something up, make no mistake about it: we must give some things up.

So, no more sound bites! Give us the respect of an informed and cordial debate without leaving out critical pieces. Stop running for office and govern!

Would you spend your entire paycheck on healthcare?

It is an absurd question, right? Well, not really. Bear with me for a bit.

As I half-listened to the White House healthcare summit yesterday, I was feeling the familiar sensation of nausea rising in response to the usual excuses and talking points from both sides. Talking at each other, parroting old memorized lines about the process rather than the substance, the illustrious group came away with no consensus. Nevertheless, this lack of results seems to be pushing the Democrats to plow through the opposition and unilaterally pass the legislation through the process of reconciliation. But will it be done well? This has always been the question.

I think this WSJ article from today has called our attention explicitly to something that has been hampering any sensible approach to the reform, the selfish blame game:

Insurers contend that they must pass on ever-higher bills from hospitals and doctors. Hospitals say they are struggling with more uninsured patients, demands by doctors for top salaries, and underpayments from Medicare and Medicaid.

And doctors say they are strong-armed by insurance monopolies and hampered by medical malpractice costs.

This is the ultimate case of missing the forest for the trees. Let's think about this in slightly different terms. You are noticing that your food bill is growing out of pace with your income, the growth of your family and the growth of the national inflation rates. Do you not stop and ask what is going on? And if the answer is that, without any other changes, your family is now consuming 20 pounds of potatoes per week, while 6 months ago you made do with 4 pounds, do you not stop and ask why? And if on top of that observation you have also noticed that your family is becoming obese, do you not stop and rethink what is going on? And if as you stop and think you notice that your obese family members are in fact making even more frequent trips to the kitchen to feed their increased hunger, do you not want to break the cycle?

Well, we are "eating" a lot more healthcare than we did 10 years ago, and in the next 10 years we are likely to be "eating"even more. If healthcare continue to grow at the current pace, we will be spending 100% of our income on healthcare before we know it; and on healthcare that continues to fall short of meeting our needs to boot. The levels of chronic disease in our society have never been higher, and the number of diseases that "require" treatment has never been more vast (think mild depression, erectile dysfunction, lactose intolerance, and many other marginal human woes, most best addressed by introspection and lifestyle modification). Reflecting this growth, our preoccupation with health and disease seems to be edging out other, far healthier pursuits. And the rhetoric of "best healthcare system in the world", emanating from the Republican opposition yesterday, is not only disingenuous, it is just stupid, especially coming from someone, in fact many someones, who should know better.

So, let's look at the big picture, folks. Let's walk away from the divisiveness of the blame game and get back to the basics. We are not the best, we are least accessible, and we are most expensive. In the world! Yes, we are special, we are Americans. But it is time to exercise that specialness by admitting the abject failure of this market experiment, get off our high horse of individuality and look to other nations and systems for a sensible solution. I for one am not willing to spend all of my time or money obsessing about my health. How about you?  

 

Does lactose intolerance really need a NIH panel?

I will go out on a limb: I think that lactose intolerance should not be medicalized.

I stumbled upon this story on WebMD discussing the NIH panel on lactose intolerance. First of all I was shocked that my tax dollars are even spent on a NIH panel on lactose intolerance. Reading the rest of the story provided ample opportunity for further shock. 

For example, did you know that we do not have an idea of what the prevalence of this scourge is? So, clearly, we need large representative studies to establish this. OK, so gathering evidence is never a bad idea. But in an odd juxtaposition to the call for evidence was this statement:

"The numbers may be elusive, but outcomes of a dairy-poor diet are easy to predict."

Really? Is this statement evidence-based, or is it setting up the argument that some associations are just too obvious to need evidence behind them? Because if it is the latter, I for one do not appreciate the double standard. In fact, the statement, though not ostensibly a direct quote from an "expert", seems rather irresponsible to me, implying that we should feel free to apply opinion-based and consensus-based principles to this question.

My final outrage came when reading that (I paraphrase) for a bona fide diagnosis one should really undergo a breath test, and other (by implication) more serious conditions need to be ruled out, such as irritable bowel syndrome and celiac disease.

Why, you might wonder, does this engender such a visceral reaction from me? Surely it is not because I do not feel compassion for those people who suffer these conditions. And it is not because I do not want to learn more about them. What worries me is that having a diagnosis requires treatment, usually with a drug directed at the symptom. I am very concerned that, instead of understanding and dealing with the underlying causes of, say lactose intolerance symptoms, we will slap the band-aid of a pill, a course much more expedient, though potentially far more detrimental, than looking for a preventive solution. In the case of lactose intolerance, the non-pharmacologic solution may have something to do with the way our milk is produced and processed: our terror of things microbial has driven us literally to sterilize milk prior to consumption. Some people feel that this "deadness", lack of organisms that through their own lactase production may potentially help us digest it, exacerbates the symptoms of the intolerance.

But this answer would be neither simple nor politically palatable. Who would support this type of research? Milk manufacturers, who would have to overhaul their operations completely? The government whose regulations drive our milk production? The small community of committed farmers who produce raw milk, but do not have corporate muscle behind them? Not likely. And what about public opinion, so durably skewed by the establishment to fear all microorganisms?

So, when a NIH panel begins looking at an issue like this, I naturally worry. And while I do want to know more about it, I am skeptical of the end-result. Are we going in the direction of 100% prevalence of chronic disease requiring 100% penetration of prescription drugs in the US?

Buddhism and antibiotic resistance

There is a concept called "samatha" in Buddhist meditation. It has to do with sitting quietly, doing nothing. The opposite of mindless action, samatha is the cornerstone of the mindfulness practice. But what does it have to do with antibiotic resistance?

Well, I came across this interesting slide presentation by Dick Zoutman from Canada. Starting at the top of page 5, the talk goes into several fascinating surveys about what influences antibiotic prescribing for upper respiratory tract infections (URTIs). The first survey was of 316 family MDs in Ontario, which, among other factors, determined "physician's desire to act" as a risk factor for prescribing an antibiotic. The next survey of 313 patients identified patient expectation to receive antibiotic as the most important driver of prescribing behavior. The latter can be interpreted as a). the patient's preference for some kind of an action or b). the patient's expectation of action on the part of the MD. Either way, "action" is the operative word.

So, what does this mean? Well, at the simplest, most immediate level, this finding confirms that education of both physicians and patients is a potentially fruitful target for antibiotic stewardship programs. But at a deeper level, perhaps something as fundamental as a re-evaluation of our approach to life is what is needed. Antibiotic overprescribing is a clear example where the philosophy that doing something is better than doing nothing is not just wrong, but threatens to send us back to the dark age of pre-antibiotic era.

Western medicine in general promotes rapid decision-making as its paradigm. In fact, when I was in practice, there used to be tremendous political capital in the bravado of rapid assessment and planning. But let's not kid ourselves: the majority of treatment decisions made in the outpatient setting do not necessarily need to be rushed in the way that our expectations have driven them to be rushed. So, let's take this sage advice and "don't just do something, sit there". It is time for some samatha in our decision-making as both physicians and patients, lest we continue knee-jerking our way into this escalating resistance catastrophe.    

 

Evidence-based... inquisition?

Remember the trial a couple of years ago that showed that group support participation was associated with prolonged survival among women with metastatic breast cancer? I've thought a lot about that over the years. Isn't it interesting that something as simple as a supportive environment can make a difference in what researchers consider to be the hardest endpoint there is: survival? In our dualistic view of the human organism, we think of support as acting in the realm of the psyche, and not the physical. And yet, here is the evidence of a psychological exposure somehow making a tangible physiologic difference.

Now, how do we do evidence-based medicine? Well, we look for clinical studies that tell us whether and how well a treatment works for a particular condition. For the rabid evidenistas among us the most valid design to provide such evidence is a randomized controlled trial, since it has the most internal validity (i.e., we are in fact likely to be studying what we think we are studying). When we pat ourselves on the back on a randomization well done, we cite the balance in the fairly obvious demographic and clinical characteristics in the two (or more) comparator groups, namely, age, gender, comorbidities, the burden of acute illness, and the like. We rarely bother with their social or psychological milieu; in fact edging up to evaluating that may be viewed by some as engaging in quackery. Well, true, these exposures are ephemeral and somewhat abstract, but look at the breast cancer study... Just because it is difficult to study and we do not have validated tools for them currently, does not mean that we can ignore, or worse yet, disparage, their potential influence. Isn't there a saying to the effect that we cannot discover that which we do not currently have the tools to understand?

And speaking of inadequate tools, a related sticky wicket comes to mind: heterogeneity. I say it is related because we do not even dare look at the underlying non-physiologic heterogeneity as I mentioned above. What may surprise the uninitiated more, however, is the fact that we do not have good tools to identify physiologic heterogeneity. And as most appreciate, heterogeneity demands large numbers of subjects to study to get a detectable effect. In fact, our research enterprise is set up to do mammoth studies for often a miniscule difference (think cardiology trials requiring 20,000 patients to demonstrate a fall in mortality from 0.5% to 0.25%). It is very likely that by using this sledge hammer method to craft the fine jewel of evidence we are missing huge chunks of useful information.

And if this is the case for our Western paradigm of medical treatment, how does it play out in our study of Eastern and other non-traditional modalities? Don't take me wrong; I am not suggesting having blind faith in homeopathy, for example. But I am curious about how cultural psychology may influence responses to such treatments as Ayurvedic medicine, say. Perhaps it only "works" in conjunction with meditation and yoga? An "Eastern bundle" anyone?

The point is I do not know the answers to these questions. What I do know is that with our approach to evidence building we are looking at a vast castle through a key hole: we are only seeing small swaths of reality. My final point is this: because so much remains in the dark, we need to be humble when exploring evidentiary basis for any intervention. A parochial attitude equating gaps in our understanding to lack of effectiveness makes us seem like the Inquisition persecuting Galileo for defining an alternate reality which turned out in the long run to be the truth we live by.  

Kids, schools and superbugs

What do the three have in common, you might wonder? Well, more than we used to think.

This story in today's UK's Telegraph reports on a school child who developed diarrhea and tested positive for C difficile. The alarming thing is that there did not seem to be any explicit risk factors for this. The appalling thing is the mis-information by the story that

Children rarely become ill with C-diff, which normally strikes elderly people in hospital. 

This is how things used to be, before the BI/NAP1/027 bug evolved in the early first decade of the millenium. We and others have shown that kids are not immune from it, and neither are other people previously thought not to possess any risk factors for it. In fact, we have a paper coming out shortly in the CDC's journal Emerging Infectious Diseases showing that in the US the rate of pediatric hospitalizations with C diff rose from 7.2 cases per 10,000 hospitalizations in 1997 to 12.8 cases/10,000 in 2006.

So why is this happening? Well, there are a couple of ways to answer this question. The proximal answer is that the new bug is better equipped to propagate. Its spore possesses greater stickiness than the old pathogenic version which we all knew and loved in the '90s, and thus is more difficult to eradicate from fomites and anatomic surfaces. It also produces on the order of 20-times more of the toxins responsible for wreaking havoc in the colon. So, clearly, this is a bug for the new millenium.

But here is the real reason for this, albeit a little more removed: antibiotic overuse. All physicians are aware of this, and we all get the connection. The way this works is that C diff is impervious to many of the antibiotics employed to treat other infections, while its neighbors in the gut are decimated. Thus, C diff proliferates to fill the void and takes a firm hold under the right circumstances. The new superbug is, of course, very likely the result of the all-too-familiar saga of resistance evolution.

Here is the frightening part: we are still overusing antibiotics! I frequently hear from my friends that their MDs offered antibiotics for something that to me is clearly a non-bacterial issue. The most frustrating situation is when I am convinced that the friend has a post-viral reactive airways cough and needs an inhaler, but instead comes home with a handful of antibacterial pills. And no one wants to take the chance. We are so risk averse that even when we are well educated about the perils of antibiotic overuse, we are still likely to take them if our doctor prescribes them. And for a doctor, with the shrinking appointment times, what is the most expedient course, particularly with a patient with an entitled attitude? You guessed it, antibiotics!

So, what do we do? My feeling is that the action has to be multi-pronged. Yes, physicians need to be held accountable for their treatment choices, but so do patients. We need to do a much better job educating the public about the dark underbelly of antibiotics, so that they can be partners in these decision. In my opinion, this may be the most critical healthcare issue of our time, given the concerns raised by both the WHO and the FDA that, if resistance emergence continues at this pace, we will be back to the dark ages of pre-antibiotic era.

To this end, The Surgeon General should pick up the banner of antibiotic education. In fact, I recently sent her a letter outlining why she might want to make this a part of her Public Health agenda. If anyone is interested in making it a more public effort, I am happy to share it and resend with more signatures than just my own. She after all puts the "Public" into Public Health.

We have got to start talking to the people about this. The resistance train needs to reverse direction. And now!        

  

HEOR as a non-clinical option

Read my post on HEOR as an option for former clinicians at the Non-Clinical Healthcare Professionals ning network blog here.

Health Economics and Outcomes Research: Too little too late?

So I went to this meeting in Washington, DC, last week, to be a part of the conversation on the value of HEOR in the industry. It was a great meeting, with about 50 attendees, most of whom are intimately involved in HEOR in their every-day lives. It was also somewhat spooky. None of the presenters had shared thoughts prior to the meeting. Yet everyone's message was oddly aligned: we need more quality HEOR studies earlier in technology development.

There was broad consensus that most companies do not have a good understanding of the role, methodologies, or value of HEOR within their development programs. And while clinical trialists are a well accepted asset to the industry, HEOR groups still tend to be the red-headed step children. They have little buy-in from other departments and minimal support from the leadership, and their output is viewed with suspicion. To be sure, there are companies who understand the role of HEOR, and these are the success stories. But majority are still in the dark.

This situation must change, and here are some of the compelling reasons why. While 20 years ago all of the emphasis in drug development was on the FDA approval, today, in our economically constrained healthcare system, no approved technology can succeed without understanding what value it brings to the table over what is already available on the market. No longer can marketers employ smoke and mirrors to develop the "winning" proposition. I would argue that, in general, the industry cannot afford to lag in its understanding of economic arguments behind the payor community.

I have always argued that manufacturers need to be the biggest experts on the diseases they are pursuing and their treatments. This by necessity must include the value proposition of their technologies beyond the statistically significant improvements over placebo required by the FDA for approval. We must develop objective milestones by which to judge worthiness of technologies in development at every point in the development process. Those who do, will adapt to and succeed in this atmosphere of cost controls. Those who do not do so at their own peril. As scientists, citizens, consumers and investors, we should make sure that manufacturers are engaging in this ongoing evaluation of their wares with a critical eye to what value they intend to bring to the society.

SCOTUS ruling: What would FDR say?

"The liberty of a democracy is not safe if the people tolerate the growth of private power to a point where it becomes stronger than their democratic state itself. That, in its essence, is fascism - ownership of government by an individual, by a group."

                                                ~Franklin Delano Roosevelt

We can argue about the strict definition of "fascism". But if we agree with Roosevelt's usage, then we must thank the SCOTUS for accelerating our transformation from a democratic to a fascist state.

Thank you also, SCOTUS, for equating my first amendment rights with those of a corporation, as if we needed to imbue these juggernauts with even more humanity. Is this confusion or is it a stubborn attempt to make the absurd true? Another Roosevelt quote comes to mind: "Repetition does not transform a lie into a truth".

On the other hand, is this an attempt to direct our human evolution down a certain path? Is the expectation that we humans are to become more like corporations? Goldman-Sachs, AIG, watch out, here I come!