Differential diagnosis of climate change

When I was in medical school, I learned that the differential diagnosis was the cornerstone of any medical encounter. Differential diagnosis involves taking a detailed history of the patient's complaint, followed by a physical exam, to arrive at a few possible reasons for the person's symptoms. Once developed, this list of potential etiologies guides the doctor's further testing, so that there is little excuse for a shot-gun approach where every conceivable test is ordered.

Through training and practice I honed my differential diagnosis skills. I developed a risk stratification approach, where I had in mind about top 5 things that could likely underlie the patient's presentation, but also included 2-3 other possibilities that, if unaddressed promptly, could prove deadly. This list would serve as the roadmap for my investigation.

I am reminded of this approach as I read the developing story of the climate debate e-mails in the mainstream press. The manufactured magnitude of the furor is certainly good for news as entertainment. It is also prompting climate change skeptics to cry vindication. What has been missing from this coverage is the weight of the evidence that supports this as our current reality. While we can argue all we want about what our earth will look like in 50-100 years, what is clear is that the temperatures are on an overall rising trajectory, the glaciers are melting, and the green house gas emissions are accelerating. Put together, these facts beg the development of a sober differential diagnosis for what is causing this presentation. I would argue that in this list we need to include not only the most likely culprits, but also those that, if not stopped promptly, will result in irreversible and deadly changes in the near future. So, even if one is willing to ignore the broad scientific agreement with regard to the future of climate change or the likelihood that human activity is driving it, common sense of safeguarding against the worst case scenario demands we nevertheless do something about these factors.

And here is the contradiction of our human psyche. Take the mammography recommendations maelstrom and compare it to our attitude toward climate change. The outraged reactions to the new evidence-based recommendations are a reflection of our better-safe-than-sorry attitude toward a deadly disease, no matter what the cost to the individual or the society. So, why do we not adopt the same stance when it comes to climate change? Why not open our eyes to the possibility that, despite the poor judgment of the scientists involved in the e-mail scandal, there is a very real possibility that our climate is changing. Once this becomes a possibility, it matters little whether it is human activity that is driving it or just the natural order of things: the only modifiable risk factor that can affect this trajectory is human activity.

So, the debate becomes simply about two choices. First is to consider the idea of climate change honestly in the context of what we know to be the truth. Second is to keep our blinders on and continue to be condescended to by those whose financial interests would be affected by the resulting societal behavior change. The right choice is obvious.      

When an information disconnect does not create cognitive dissonance

Just posted this on the BMJ's doc2doc blog  

Is it rare for an information disconnect to be accompanied by a complete absence of cognitive dissonance? And does such an absence signal mere ignorance or deliberate intellectual dishonesty? There is such a gap present in our healthcare debate.

Think about this. The Republican Party has always touted itself as a fiscally responsible party. Under this banner they like to cut taxes and minimize what they call "entitlement" programs (these of course are just the programs that provide a modicum of support for those left out of our consumerist equation). So, given this as a top priority in the hierarchy of their agenda, there is no contradiction in their stance against public coverage of healthcare in the US. OK so far?

Well, here comes the disconnect (no pun intended): they do not wish to limit any and all existing and future healthcare interventions for our public, including the Medicare population. They have made up rows of dying grandmas whose ventilator access is rationed by the government death panels, and have equated the proponents of rational rationing with the Nazis. So, where is the disconnect? Well, given that Medicare expenditures have been growing at rates far outpacing the US annual inflation (up to 12% in some years), how do we propose to pay for this escalation if we are unwilling to limit care? Well, one way is by raising taxes. This thought, of course, sends the Republicans sobbing into their hankies -- such a solution is anathema to their pseudo-science of supply-side economics. In the meantime, a few years ago they added to the Medicare bill by creating Medicare Part D, or prescription drug coverage. In and of itself, this coverage is a good idea. Unfortunately, Medicare is not empowered to deny coverage based on cost or cost-effectiveness, and it is further prohibited from negotiating drug prices. Well, in 2006 this program cost Medicare over $40 billion. And George W. Bush insisted on lowering taxes at the same time. And he started two expensive wars, too. So, am I just dense because I cannot get these numbers to add up? Am I missing something that is indeed fiscally responsible about the Republican stance? Why does this disconnect not create any visible cognitive dissonance for them?

I think I know why. They are not the party of fiscal responsibility, but the party of survival of the fittest consumer. An entitlement program creating corporate profit is good, while one geared at improving our society is a manifestation of the Nanny state. In fact, the Nanny state has run rampant in the last 30 years wiping noses of our corporate giants with their supply-side religion, while shaking off the needs of the public as socialist propaganda. There is no fiscal responsibility here, only the single-minded pursuit of more for less. The US currently has a $12 trillion (this is worth writing out just for its shock value: $12,000,000,000,000) debt on the books. This does not take into account what is already committed to future debt, which by some accounts exceeds utterly unimaginable $60 trillion. In fact, by 2019 the US government's annual interest on its debt will be $500 billion more than it is today, going from $200 to $700 billion! Just the interest, folks!

So, while I can almost intellectualize the Republicans' selfish desire to keep 46 million people in the US from availing themselves of healthcare, I deplore their dishonesty in hiding behind the aegis of fiscal responsibility. The last time our budget was balanced, a Democrat was in the White House. A Republican started an ill-conceived war and cut taxes at the same time -- this is living in a fantasy of a most destructive kind! So, don't make the healthcare bill about anything other than what it is about: the potential profit to be made from keeping healthcare status quo on the backs of growing numbers of citizens of our nation. It makes you look not only hypocritical, but also supremely stupid!                  

The century of unintended consequences

Where to begin? The phrase "unintended consequences" has been making rounds in healthcare, politics, and other venues of late. It appears most pronounced in healthcare, and has been clearly brought out by the cancer screening debate last week: while taking for gospel that early detection saves lives, we have been subjecting countless people to unnecessary, invasive and sometimes deadly interventions. Oooops, we say, an unintended consequence of our good intentions. You do not have to look far to see others. The mounting problem of antimicrobial resistance due to egregious overuse of antibiotics, mounting data on the downsides of the widespread use of proton pump inhibitors, manifest as an increased risk for C diff diarrhea, pneumonia, and most recently, because of heretofore unappreciated interaction with Plavix, strokes and heart attacks.

Unintended consequences can also be seen in other areas of our lives. The thoughtless experiment of mortgage-backed derivatives and their implosion, the nearly irreversible effects our thirst for fossil fuels on the environment can on the one hand be attributed as unintended consequences. But I have to say, I am not buying it. Letting us all off the hook with this innocent statement is as simplistic as it is dishonest. It is like letting your kid off the hook for stealing a candy from the store because he did not foresee being caught. In fact, even the expression itself, "unintended consequences", is seemingly designed to demonstrate our sudden passive and victim-like situation. "But I did not intend for this to happen, so I am an innocent victim here". Pshaw! Much of what we call unintended could have been foreseen, if we had the will to plan ahead. The issue is that we are not, and are steamrolling ahead from moment to moment with no thought given to long-term consequences.

It is a fact that Nobel laureate Joshua Lederberg predicted in the 1970s that bugs would evolve resistance in response to our antibiotic warfare on them; even then he cautioned against overusing these agents. It is a fact that you cannot keep building a house of cards with imaginary assets without having it collapse. It is a fact that you cannot expect to keep drilling and emitting with one hand, while with the other eliminating vast carbon sinks, without noticeable climate change. It is also absurd to call our lack of viable fossil fuel alternative an unintended consequence: in what closed system can a resource be infinite? And once this resource is inevitably exhausted, what then?

In truth, the entire 20th century has been a cruel experiment in consumerism. Decisions made in the 1920s and the 1950s about converting the US citizens into a race of single-minded consumers were deliberate and well planned. And of course, the intention was clear: to increase the wealth of the few. I am confident that no one explicitly intended for this accumulation of wealth in a few hands to result in an ever-widening gap between the haves and have-nots. But is it so difficult to imagine that this is a not unexpected result of single-minded pursuit of wealth? Over the decades of industrialization, farmers and small-scale merchants, able until then to support themselves independently, abandoned their country seats and their communities to move to the cities to fulfill the shining promise of wealth and happiness unscrupulously promulgated in the name of this relentless pursuit of wealth. When the internal combustion engine became a reality, and as the city populations expanded, the suburban dream was born, isolating people further into their cookie-cutter homes away from organic communities of their ancestors. The last 30 years of the 20th century brought with them the proliferation of technology that has allowed us to work 24/7, be connected (only virtually), and, more importantly, to buy stuff any time of day and night from anywhere in the world. This American dream has left 80% of the US population behind economically, our main fuel source on the brink of disappearance, and American society more unhappy and fractious than any other time in the past century. Our politicians and business leaders unabashedly preach selfishness, greed and lies. All in the name of money and power. Unintended consequences? I think not.

Today, when divisive politics are playing out on Capitol Hill for all the world to see unequivocally our degraded values around social support and responsibility, it is worth pausing to contemplate what we are undertaking today that will result in "unintended consequences" tomorrow. Is it honest to say that the poverty, crime, disease and deprivations in migrant worker shanty towns in Mumbai and Namibia and China and countless other places in the third world, migrants who abandon their rural communities in search of the Western promise, are all truly unintended consequences? Or are they really collateral damage of our sick zero-sum economic game? And just because these consequences were not our primary intent, we cannot wrap up in their cloak of innocence: these consequences were and are entirely foreseeable, convenient or not. We are guilty!

So, while we in-fight about who should have access to healthcare, whether abortion or gay marriage is morally tenable, and what Jesus would do, we have been made accessory to the real catastrophic atrocities -- a growing local and global economic apartheid in the service to our corporate masters. The ones that are bleeding are we and our children. But of course, these are just unintended consequences.

The good news is that we can each do something to mitigate this overwhelming disaster: stop buying crap you do not need! Stop buying it because it is on sale -- you already have enough crap. Think about it: some of the sale prices are not even enough to pay for the fuel it takes to run the machines that made the piece of crap in the first place. And it will probably end up in your trash within the next 12 months anyway. How is this living with the future in mind? Really, before you make your next purchase of anything, think hard: there is no such thing as a free lunch. Chances are, your purchase will only better the bank account of a small minority of people who have produced the item, and in the process contribute to the environmental and spiritual devastation for many. Stop being helpless, stop pressing the lever and stop being a cooperative slave to this insidious juggernaut of consumerism. You will feel better if you can claim intentionality in building a better and more lasting world.                                        

Mammography and conflict of interest disclosure

I don't know about you, but I am really struck by the lack of support for the new USPSTF evidence-based recommendations for mammography screening by the heavy-weights in this area -- American Cancer Society, American College of Radiology, and several institutions that are known bellwethers for clinical practice. But why should I be surprised?

A couple of weeks ago I posted about conflict of interest in healthcare research here. There is a veritable witch hunt by professional organizations and peer-reviewed journals to rout out any appearance of a conflict of interest, but pretty much only as it applies to private research funding. What about mammography screening and the loud chorus of dissent with the recommendation? Well, consider the sources. Does it seem that their opinions may be somewhat tainted by their tremendous financial interest in maintaining and even extending the status quo?

I do not wish to accuse anyone of nefarious motives; I believe Hannah Arendt's considered assertion that evil is banal -- we do not plan it, we just slip into it. In fact I am not even willing to call the dissenters evil. I just want the conflict of interest disclosures to apply to everyone equally. The public relies on our healthcare institutions to promulgate policies with our health and not their financial advancement as the primary goal. As a researcher who takes research and consulting dollars from private industry I am expected to disclose meticulously all of my financial interest in a manuscript that I submit for publication or a talk I give. In the same spirit of full transparency, I call on all organizations voicing an opinion on the subject to disclose their financial stake in the mammography enterprise and how much revenue they stand to lose from adoption of the current USPSTF recommendations. Explicit disclosure of such conflicts of interest is an important step in helping the public understand the implications of the skirmish around this evidence.  

Is the art of medicine inefficient?

I was listening to NPR's Marketplace Morning Report today and heard that Hershey has an eye on the British confectioner Cadbury. Now, I love Cadbury Crunchies, the ones that you can only get in the UK, and dread the prospect of having them disappear. But that is off topic. The story talked about how the company, Cadbury, has become more efficient since it hired an American CEO, and it is looking to further those efficiencies. In this context the word "efficiency" was kind of like fingernails on a blackboard. Here is why.

When we talk about efficiency in the business world, we are basically talking about getting as much profit as possible. This profit is wrung out of the system by reducing production costs to the maximum extent possible and by charging the top price that the market allows. Some of the ways in which the US companies have increased their efficiencies over the last 30 years are 1). by moving manufacturing to developing nations, where labor is extremely cheap, 2). by reducing the US workforce to the bare minimum through increased use of automation (and don't we all look forward to talking to a computer when we are looking for customer service on the phone!), and 3). keeping down the US workers' wages at their 1975 levels, even as the productivity has grown exponentially.

So, now I come to my concerns about healthcare. Efficiency is one of the domains identified originally in the Institute of Medicine's report "Crossing the Quality Chasm" as a measure of a functional healthcare system. Since then, the Commonwealth Fund has consistently given a poor grade for efficiency in their annual report card. And there is no question that the system as it stands today breeds inefficiency.

On the other hand, I worry that in our traditional American single-minded zeal we will go overboard on efficiency in healthcare purely in the business sense. The Six Sigma models and similar lean techniques are designed for the world of business. Medicine, I would argue, is a densely cognitive field, and despite the illusion that computerization will obviate the need for human attention, we should always demand that a human being, not a computer, is thinking about our medical picture in a holistic way in our hour of need. So, while we really do need to get rid of the considerable amount of blubber in the system as it exists today, we should never tolerate the adoption of the the traditional business view of efficiency. We must be vigilant against reproducing the curve above in our healthcare system. And as much as health IT is seen as the holy grail of medicine, let us not work under the woeful misapprehension that this valuable and necessary tool can replace medicine's practitioners, who spend their careers cultivating the art of medicine, as well as the science. And if you do not believe that there is art to medicine, you have never had a serious encounter with it either as a clinician or as a patient.

News haiku

Hunger killing kids,
Soldiers are killing themselves,
Murdoch spewing lies.

Does number needed to treat help with rational decision-making?

Here is the perfect illustration of how irrational and emotional the issue of breast cancer is. Take the current maelstrom over the USPSTF's new screening mammography recommendations, which now advise against routine screening for women between the ages of 40 and 49 and change the recommended interval for women 50 to 74 years old from yearly to biennial screening. Let's focus on the number needed to invite (a diagnostic test's analogue of the number needed to treat, NNT). The NNT of mammography for a woman in her 40s is nearly 2,000, meaning that we need to screen 2,000 women to prevent 1 breast cancer death. Similarly, among women in their 50s, this number is about 1,300.

Let's not even talk about what the implications of over-diagnosis and over-treatment may be in all these women; I have written about this in the past here and here. Let's just focus on costs. An average cost of a mammogram is ~$100. So, multiplying the 2,000 NNT by $100 yields $200,000 per life saved. Again, if this were the only cost (and again, we are staying away from costs of repeat testing of false positives, invasive diagnostic testing and potential over-treatment and its attendant complications), I would say that it might be reasonable, especially when you take into account the number of years that can be saved for a woman in her 40s.

Now, let's look at the only therapy on the market that reduces mortality in patients with severe sepsis, drotrecogin alfa (activated). Its NNT is 16. That's right, it takes treating 16 patients to prevent 1 sepsis death. Given that a course of this drug costs ~$10,000, the cost to save 1 life is $160,000, or not that different from screening mammography in the 40-49 age group. Though the drug cost is 2 logs higher than that for mammography, the total population is about 2 logs less, so the total costs may be comparable. Yet, there is no battle going on for the use of drotrecogin alfa, and is has been all but abandoned by the ICUs in the US, mostly due to its expense.

So, without making any kind of a value judgment or a politically motivated statement, is this not a double standard? Is this not irrational and selective? Is this a result of a disease with a strong lobby versus one that does not have a patient advocacy group (mostly because 50% of these patients die in the hospital)? Or is it that mammography is perceived as prevention while drugs are disease treatment?

I am really not sure what the answer is to this apparent double standard. I also will refrain from proselytizing about the willingness to pay and whose money and the potential harm and even death due to over-diagnosis and over-treatment. But people, we do need to confront our irrational demons of inconsistency. On the other hand, if we cannot make these allocation decisions rationally as individuals, don't you think we would benefit from a body whose sole purpose it is to do this transparently and in an evidence-based manner?            

On Oprah's interview with Sarah Palin

While millions are hungry and broke,

Recession, our oil's up in smoke.

Fear not, because Oprah

Is charming the cobra.

The answer to all is "Go Rogue!"

The simple math of healthcare access

Look, here is the bottom line in broad strokes.

The costs of healthcare have been rising exponentially, but people's incomes have not. Despite the biggest economic expansion over the last 50 years, and despite astronomic rise in our productivity, the real wages for the bottom 80% of all earners have not increased one iota since 1975! This means that, while the costs for all products and services have grown at the pace of inflation or more rapidly (as in the case of healthcare), our buying power has remained stagnant.

What is the result of this disparity? Well, one result was the implosion of the mortgage-backed derivatives market. Some economists posit that the productivity-wages gap allowed corporations to stockpile enormous wealth. This wealth, in turn, was translated by the Wall Street Wizards into the obscure mortgage-backed derivatives Ponzi scheme, where mortgage loans lent to people with no way to pay them back were being used as collateral for these assets. The math is simple: productivity was up, wages stagnant, consumerism rampant, cash abundant -- bingo! The nation lived beyond its means for over a decade, imaginary wealth made and lost in a blink of an eye.

What does any of this have to do with healthcare? The connection is pretty obvious to me: rapidly escalating costs in the face of stagnant wages and diminished capital. Without any changes in the trajectory of the healthcare costs even more people will be unable to afford health coverage. This simple arithmetic should not be so difficult to grasp. Closer to home, anyone who now says "Not my problem, I can still get 'everything' ", prepare for it to become your problem. Who will pay for "everything"? Without the needed cost containment, the faces of those left behind by our cruelly inequitable system will be getting more and more familiar.

30 poems in 30 days

Check this out! Great fundraiser idea. If you want to sponsor me, please e-mail me at Healthcareetcblog@gmail.com.

Better late than never

Just heard about this fundraiser
To support literacy education.
Seemed like a good cause to get behind,
So here I am trying to rhyme.

I am not poetically inclined,
But do indulge me in this task.
Please do not judge these sorry lines,
Just go with the flow, and do not ask

For perfect rhymes -- they will not come.
I turn a phrase in mostly prose.
In fact I write about science,
And fear that poetry will expose

My inability to rhyme,
My inclination to be free
In how I say and what I find
To be of importance to me.

This verse is done for greater good.
So please won't you support this cause!
If you so choose, why then I would
Consider ending without pause.

Public Option: the Democrats' albatross

I have purposely held off on putting in my 2 cents on the House healthcare bill passed last weekend -- there has been enough noise about it. As the dust is settling, I am thinking this is a good time to weigh in.

The big elephant in the room is whether or not Public Option included in this version of the bill will achieve the essential goals of improved access and quality, and curbed expenditures. As I understand it, the Public Option is meant to make coverage available to a larger swath of the US population than who is covered today. It does so by qualifying people, particularly those too poor to afford private insurance yet too well-off to qualify for government-sponsored programs, and small business owners. It claims to have a lower overhead due to reduced emphasis on profit and lower administrative costs. It is also meant to contain costs by its ability to negotiate reimbursements at the point of care, though the legislation does not allow the government to pool its negotiating muscle across all of its subsidized healthcare programs (Medicare, Medicaid, CHIP). Therefore, the Public Option reimbursements are mandated to be no lower than Medicare and no higher than the average private payments.

So, the way I read the legislation, the downward cost pressure is still at the interface of the patient and the provider/intervention. So, how is this any different from what is happening today? I would argue that the private sector insurers are probably pretty aggressive at holding the providers' feet to the fire already, and so far they have been unable to contain costs. Additionally, if we look at Medicare, its expenditures have also been sky-rocketing, despite a strong negotiating position at the provider level. So, why would an additional government-funded mechanism, that is different from and weaker from negotiating standpoint than Medicare, succeed at this Sisyphean task?

The bill does provide the Department of Health and Human Services with the ability to develop and pilot new coverage and reimbursement schemes. So, down the road it is possible that the Public Option will provide a laboratory for how best to fix our perversely aligned incentives to promote better health and not schemes to maximize income. Some estimates by the CBO indicate that the Public Option for various reasons will enroll only 6 million people. In addition, while all providers who now accept Medicare will have the opportunity to be on the Public Option provider panels, they can also opt out. Taking into account the impending 21% proposed cut in Medicare reimbursements and the relatively small number of patients predicted to take advantage of the Public Option, why would providers not opt out aggressively, the way many have opted out of Medicaid patients? And while some of the remaining 40 million uninsured will now be covered under Medicaid and CHIP, too many will still be left in the crevasse of no healthcare coverage to fend for themselves.  

So, the House bill's Public Option does not seem to me to be the answer. If it is to be administered in a straight-jacket of making sure that profits in the private sector can continue to climb and patient-consumers can still operate under the misapprehension of being entitled to every touted "advance", no matter how insignificant, Public Option is a recipe for failure. I am also not sure how much attention will be paid to the output of the nascent comparative effectiveness enterprise or what statutory or political backing there may be to follow through on these data. The bill does not go nearly far enough to ensure equity in the US. It has been diluted by pandering to its vocal opponents who, while counting and recounting what is in their own purses, are content to continue a system that has created a disposable class of citizens who cannot afford healthcare. Its passage may send a short-term political message to its opponents, but its long-term failure will be an albatross around the neck of the Democratic Party for decades to come. Not to mention the travesty of continuing to abandon millions of our friends and neighbors to the whims of the profiteering healthcare marketplace.    

Our children's future: healthcare vs. peak oil

Do you believe in peak oil? What is peak oil? Peak oil, also referred to as Hubbert's peak, is a projection, based on our historic patterns of consumption, of when the demand for oil will outstrip its supplies. The world uses about 80 million barrels of oil per day, mostly in the transportation sector. So, to keep up with this demand, at least this much oil needs to be excavated from the ground daily. In reality, even more is needed to keep some in reserves. Hubbert was a geophysicist who in the 1950s predicted that, based on the current patterns of oil consumption, we would reach peak oil sometime early in the 21st century (see graph).

How is this possible, you ask? A better question is how can it be otherwise? If you really think about it, oil is the product of the earth's development and evolution. It is an alchemy of dead organic matter and glacial and volcanic catastrophes brewed slowly over hundreds of millions of years. In this sense, oil is not a renewable resource, at least not within the human time frame. And as you can see, the curve of the production until the peak appears mostly exponential, with some stops and starts. Exponential growth, by virtue of its accelerated trajectory, is unsustainable in a closed biological system, where the production of resources cannot keep up with their consumption.

So, peak oil is not hard to imagine, given our gluttonous consumption of it. So, why is it that the international body, the International Energy Agency (IEA), responsible for forecasting our oil situation has been so reluctant to admit to the impending peak oil? Turns out, according to a report in today's Guardian, that it has been cooking its numbers because of the pressure from the US. An unnamed whistle-blower has come forth to indicate that

"...the US has played an influential role in encouraging the watchdog to underplay the rate of decline from existing oil fields while overplaying the chances of finding new reserves."

Why would the US encourage such deception? Apparently because we are worried about the implications of this revelation to the markets. So, while shouting loudly about fiscal restraint and sloganeering about the impact of universal healthcare coverage on our children's financial future, our nation, with its eyes shut tightly, has been on a collision course with a very real and close wall of peak oil. This is simply unwise.

We can make up all kinds of stories about the potential reserves. I am not sure why these stories seem more plausible to the same people that energetically deny human contribution to the climate change, except to say that we believe what is convenient for us to believe. Everything you see on the graph below beyond the real oil reserves is imaginary. But, even if it were feasible to get at these potential resources, they would be fraught with an enormous carbon footprint, not only while mining, but also when used as fuel.

And, by the way, haven't we learned our lesson about investing in imaginary assets? Is that not what our investment banks were doing with the mortgage-backed derivatives?

Come on, people, the writing is on the wall. Fossil fuels are on the brink of exhaustion. And we have more "stuff" than we can use in multiple lifetimes! Let's stop for a moment and take the toll of what we have done to the planet. Let's really consider our children's future, and their children's and theirs. In fact, perhaps we can remind ourselves of this old Iroquois philosophy:

"In every deliberation, we must consider the impact on the seventh generation... even if it requires having skin as thick as the bark of a pine."

This is our opportunity to consume less and to tell President Obama to make a real difference in Copenhagen!

Conflict of interest in healthcare research

I have been in San Diego for nearly an entire week, and am eagerly getting ready to head back to my beloved New England tomorrow after I chair my last session in the morning on the extra-pulmonary complications of critical illness. Guess what my talk is on? That's right, C diff.

A hot topic at this meeting of the American College of Chest Physicians (affectionately known as Chest) has been conflicts of interest. Yesterday I chaired and spoke at a session talking about what good collaborations look like between the Industry and Academia. Today there was a fascinating session on a related topic, which included talks from Catherine DeAngelis, the Editor-in-Chief of JAMA, as well as Richard Irwin, the Editor-in-Chief of the journal Chest, and two other speakers: Jim Roach, MD, representing the Industry point of view, and Ian Nathanson, MD, who is a part of the Chest COI working group. Although all speakers attempted to be balanced, the sum total amounted, as one would expect, to at least some Industry bashing and finger-pointing. It is interesting to me that, while people do not hesitate, appropriately, to include all fraud and result falsification, they usually conflate these into the "Evils of the Industry", regardless of the funding received by those defrauding the system. Also, what is not mentioned are the denominators of this potential relationship of fraud with manufacturers. The story is usually told thusly: 1). Look at the proportion of research funded by private vs. public funds (~85% of all clinical research, according to Dr. DeAngelis). 2). Look at the systematic reviews that indicate that Industry-sponsored trials are more likely to show results favorable to the product in question (true, but could this be because Industry-funded studies are designed with more precision? Or perhaps it is because of the nature of our regulatory process: early phase studies shed light on what can be expected, and the later phase studies merely build on that information. It is possible that our regulatory path promotes lack of equipoise, but that is a discussion for a different time). 3). Here are a bunch of case studies of fraud that we have uncovered (usually quite a few from the Industry, but also a number not funded by private dollars), 4). Therefore, the fraud is a big problem with Industry-funded work.

If I were structuring a scientific argument in this manner, I would be accused of using ecological data for hypothesis testing. The leaps of faith required are considerable. I do not wish to minimize the abominable behavior exhibited by those with a considerable monetary interest at stake, or by those that have benefitted at the trough: their lack of ethics and concern for the public has brought public cynicism and apprehension about everything we do. However, it is not OK to mitigate this terrible situation by singling out only the most visible potential culprit, made visible simply because of the volume (denominator) of work it supports. This tactic reeks of scape goating for personal gain -- so as to divert the spot light from transgressions of other stake holders, no matter how egregious.

The reason that manufacturers present an easy target is that they have in the past been unethical in so many visible cases. Another reason is that the source of the conflict of interest that exists for the Industry and investigators they fund -- money given for work that will advance the cause of the particular technology the company owns and benefits from financially --is particularly easy to identify. To be sure, we do need to deal with this source of COI carefully if we do not want to lose our credibility completely as the scientific community. At the same time, turning this process into a witch hunt is a mistake. Barring Industry scientists from presenting their work in a CME forum at professional society meetings, fro example, runs counter to the transparency mandate of authorship guidelines. Further, it denigrates the achievements of often prominent and dedicated scientists, and assumes guilt until innocence is proven.

In so many ways, this reactive stance is a response to the Congress's interest in the issue, and the mad rush to deal with it surely reflects an earnest attempt to clean our house. While I salute journals and societies for addressing this difficult issue, if some of the parties are locked out of the discussion, the attempts will look like and amount to nothing more than window dressing. Unless we are willing to overhaul completely how we do medicine in this country and take out the profit motive altogether for everyone (this is in fact my preferred solution, but given how difficult it has been to pass even the current anemic public option, universal socialized healthcare system does not stand a chance), it is critical to be inclusive and to find the most sensible and well thought-out solution to this visible violation of public trust.

The BIL:PIL unconference: Challenges and opportunities

Yesterday and today I have been privileged to attend the BIL:PIL "unconference" in San Diego, organized by Jonathan Sheffi and colleagues. Yesterday was awesome with amazing speakers and brilliant ideas. For someone who is used to hard data presentations to and from physicians and scientists, it is great to get out of that silo and see what the rest of the world is thinking about the challenging state of healthcare. Some of the speakers dazzled us with new more efficient approaches to drug development, while others took us on futuristic voyages of the brain's dark matter, artificial intelligence and the promise of stem cells. I cannot wait to hear today's presentations -- tickles my brain just to think of all the new stuff I am learning! It is also neat to meet and rub elbows with such luminaries as Val Jones (speaking today at noon PST) and Gregg Masters, who are not just smart and eloquent, but also really delightful people.

Today I get to give my "untalk". Just by way of a preview, very little of what I will be talking about is new. In fact, when I was putting it together, I tried to look up the antonym of "innovation". Guess what? There is not one in the English language. So, I will have to call myself something else, since, though creative, I certainly do not rise to the ranks of the brilliant innovators I stand beside. At the same time, I believe my approach will bring something valuable to the table. Perhaps I need to come up with an adequate moniker that describes my philosophy. Wait, I think I've got it! But I think I'll wait to unveil it during my talk. It is at 3:00 PM PST and you can see the live stream here. See you at BIL:PIL!

Twitter and information accuracy

I am going out on a limb: I do not wish to offend anyone, particularly those for whom I have a great deal of respect. However, this is potentially a moment where opinions need to be exchanged in the name of improved mutual understanding.

The other day I re-tweeted a tweet from someone whose Twitter activity I enjoy very much.  I like where his links take me, and I appreciate the intellectual and emotional honesty of his own writing. The message I re-tweeted was about Gardasil, Merck’s HPV vaccine marketed in the US. Diane Harper of the University of Missouri is a prominent researcher who was heavily involved in the Gardasil development program. Over the last several months she has cast serious doubt on both the cost-effectiveness and the risk-benefit profile of the vaccine. One of the facts she pointed out at the recent 4th International Public Conference on Vaccination in VA was that, though the drug is marketed to girls as young as 11 years old, the vaccine has never been formally evaluated in girls under the age of 16 years. Neither its safety nor efficacy, let alone effectiveness, is known in the younger population.

A link in the re-tweeted message took me to a newspaper article summarizing Dr. Harper’s objections to the wide-spread use of Gardasil in the US. As luck would have it, shortly following the first tweet, the author re-tweeted another message. This one directed one to a blog post by a British EBM celebrity railing against a deliberate fabrication of information by anti-vaccination ideologue reporters to cast doubt on GSK’s Cervarix in a story published in the British tabloid Sunday Express. In this blatantly sensationalist anti-vaccination article, the journalists were allegedly quoting Dr. Harper’s objections to Cervarix, objections that seemed identical to those she has voiced with regard to Gardasil. Being dubious of the veracity of such claims, the blogger diligently fact-checked with Dr. Harper directly, who promptly denied ever making any claims, or indeed having more than superficial familiarity with the data on Cervarix. In fact, the journal has removed the story from its web site. So, the blog recounted a necessary he-said she-said anatomy of distorting facts in service of the tabloid rag's sales. Perhaps in the UK these disreputable pseudo-news outlets have wider credibility than in the US. But I do not see that I need to get involved in further discrediting a source that would just as likely put news of alien abductions on its front page as the lies about a vaccine.

Since I have been following the Gardasil saga, I was interested in Diane Harper’s views of the data in the context of the epidemiology of both HPV infection and cervical cancer. Additionally, being a health services researcher, the cost-effectiveness questions also caught my eye. Not to mention the information about the age thresholds in the trials. For these reasons I re-tweeted the story. And while the debunking of the anti-Cervarix rhetoric was interesting, it did not add to my knowledge base, other than to trust all tabloids even less, if that is even possible. The blog post thus made the point that there is no evidence to date for any of the dire events that the reporters in their anti-vaccination zeal had made up. This does not excite me: as I keep pointing out, the absence of evidence does not mean that there is evidence of absence. The best we can say is that the vaccine proved safe enough in trials to be approved, and to date we have not seen any red flags. No new information here, other than confirmation of the lies, though, given the source, no big surprise. So, the post being simply more of voyeuristic than scientific interest to me, I chose not to re-tweet the second tweet. Particularly since this is a “controversy” I had not been following closely.

Shockingly, when I got back on Twitter a few hours later, I had a polite but insistent request from the author of the tweet to re-tweet his second, Cervarix, tweet. Now, because I respect this person, and because I am confident that, being an accomplished journalist, he was simply seeking balanced information, I complied without further ado. After all, this was harmless enough. However, I got to thinking about when it might be OK for a tweeter to insist that a particular tweet get re-tweeted. Journalists seek balance in reporting. Scientists seek balance when summarizing evidence. Both are averse to cherry picking. I am sure that my esteemed colleague felt that I was cherry picking the information to fit my point of view. In fact, I wish to assure him that I was cherry picking simply on the basis of what advanced my knowledge on the subject: a story about an important public meeting on vaccination vs. a recount of a tabloid inaccuracy. And even if my intentions had been nefarious, Twitter is neither a responsible journalism vehicle nor a peer-reviewed publication. The cynical view is that information chaos reigns, and while we should all strive for responsible diffusion of information, there is no contract to this effect. The less cynical way to look at it is that Twitter is an egalitarian vehicle, where individuals can make up their own minds as to what they deem important.

So based on this experience, let me respectfully suggest an alternative course of action around similar future situations, should they arise. Rather than emphatically asking to re-tweet a specific post, why not inquire why the person chose not to in the first place. And though it may be challenging to give a full explanation in 140 characters, it is worth a shot, as it is guaranteed to advance our mutual understanding and to build better relationships.

Fellow consumers: we cannot escape history

The consumerist takeover of the US psyche which began in the 1950s is complete: While we have been in our gluttonous torpor, our citizenship title has been revoked in favor of "consumer". Appropriately enough, this blessed event took place yesterday in a location bearing the hopeful name of Sunrise, FL, where, in an Orwellian concession to the fans of "Going Rogue", the Speaker of the House of Representatives of the United States of America dropped the objectionable "Public Option" and replaced it with the promise of "Consumer Option".

Yes, ladies and gentlemen, we are no longer the public, we are merely consumers. Whodda thunk it? In the nation built upon the principles of life, liberty and the pursuit of happiness, we are officially empowered to pursue only STUFF. Of course, it was a matter of time. The success of the marketing enterprise over the last 50 years is astounding. What? You think this happened by accident? Ever heard of Victor Lebow? As an economist in the 1950s, he is credited with the following words:

Our enormously productive economy demands that we make consumption our way of life, that we convert the buying and use of goods into rituals, that we seek our spiritual satisfactions, our ego satisfactions, in consumption. The measure of social status, of social acceptance, of prestige, is now to be found in our consumptive patterns. The very meaning and significance of our lives today expressed in consumptive terms. The greater the pressures upon the individual to conform to safe and accepted social standards, the more does he tend to express his aspirations and his individuality in terms of what he wears, drives, eats- his home, his car, his pattern of food serving, his hobbies.

These commodities and services must be offered to the consumer with a special urgency. We require not only “forced draft” consumption, but “expensive” consumption as well. We need things consumed, burned up, worn out, replaced, and discarded at an ever increasing pace. We need to have people eat, drink, dress, ride, live, with ever more complicated and, therefore, constantly more expensive consumption. The home power tools and the whole “do-it-yourself” movement are excellent examples of “expensive” consumption.

Really! In broad daylight and with complete seriousness. Are you awake? We have been manipulated for 5 decades. We have generated tremendous wealth for a few, we have decimated our environment, and we are less healthy and happy now than we have been in the last 30 years! So, of course, what we need is more consumerist rhetoric; thanks, Nancy for doing the right thing.

What will it take to break us out of this hypnotic state? What will it take to alter this mystical-magical thinking that the next purchase is going to make our lives everything we had imagined? Stop pressing the lever, get off the spinning wheel, take your own pulse and a deep breath: we have hit the wall.

[Hat tip @ivanoransky, @epatientDave, @paulroemer]

Thomson Reuters: $700 billion in wasted healthcare costs annually -- UPDATED

Another report quantifying the staggering waste in our US healthcare system, "the best in the world". This one is from Thomson Reuters, and is awfully similar to that from PwC. They estimate that the waste is between $505 and $850 billion annually.

Because a picture is worth a thousand words, I created this graph based on their estimates. Enjoy!

Silly me, cannot upload an Excel graph into the blog, so here are the numbers:

Paper record/test duplication	6%
Overuse	37%
Fraud	22%
Administrative inefficiency	18%
Medical errors	11%
Preventable conditions	6%

Bohemian Bankruptcy, by Drag Queen

Oh, my God! This is scary great on so many levels! (hat tip to @Nika7k)

Are 37 minutes of sleep worth $800,000,000?

It seems appropriate to repost my blog from July 29, 2009, in view of this excellent article from Lisa Schwartz and Steve Woloshin from Dartmouth in the current NEJM -- it is a must read. You will not believe what some of the effectiveness claims in FDA-approved drug labels are based on!

Voodoo Medicine

An excellent post the other day on the Science-Based Medicine blog addressed "Incorporating Placebos into Mainstream Medicine". In it the author, Harriet Hall, rails against complementary and alternative medicine as inherently leveraging the placebo effect. She goes on to ask "What if scientific medicine were to co-opt the CAM movement? We could take these treatments out of the hands of the less ethical practitioners and outright scam artists and place it in the hands of those who are more likely to be altruistic". This mouthful grabbed my attention.

Here is what bothered me. The traditional healthcare providers believe that they are practicing scientific medicine. And why wouldn't they? The clinical research establishment (of which I am a part, mind you) is constantly touting new breakthrough results, and the FDA after all only approves therapies that are proven to be effective! Well, not so fast; there are an awful lot of assumptions in this statement. First, how much of the research out there is of high quality and how much is bovine excrement? Next, even the best of studies that find statistical advantages to one course of action over another show minute, potentially inconsequential differences that a lot of the time translate into zero benefit outside the laboratory of clinical trials. And as for the FDA, they are paid by the manufacturers to review and approve drugs and devices. And even though I trust in their earnestness, most of the time they require only statistically significant differences (microscopic ones can still emerge given a large enough study size) in outcomes that are not all that meaningful to one's well-being (e.g., drop in cholesterol as a surrogate for a reduced risk of death from cardiovascular disease, a less straight-forward relationship than you might suspect).

So, there is the science bit. As for ethics, I will give Dr. Hall that for the most part MDs do try to practice what is commonly accepted as scientific medicine. The key here is "for the most part". Remember Gawande's story of McAllen, TX? And lo' and behold, just a few hours ago Reuters reported a bust of a large Medicare fraud scheme, where, believe it or not, docs were charging $3,000 to $4,000 for simple knee and shoulder braces and heating pads, calling them "arthritis kits". And while I do not question the ethics of the majority of my brethren, this incident sure underscores that, just as CAM practitioners, the house we live in is also made out of glass.

We have a long way to go to achieve good health in this country. Our culture has become over-reliant on experts in everything, including healthcare and evidence, to slap our wrists when we have been "bad" and to give us marginally useful advice on how to cure our ills. We must question our assumptions. I agree with Dr. Hall, nothing replaces a combination of evidence and experience. Or the placebo effect.

Civic involvement: a communist plot?

Absurd, you say? Not at all!

That paragon of intellectual reasoning, Glenn Beck, has been conjecturing that the new call to volunteerism by the Entertainment Industry Foundation is a giant mind control experiment by Obama aimed at fostering zombie-like agreement from unquestioning public. Really? He is worried that we will soon find ourselves in Mao's China. Hmmm, very interesting.

Coincidentally, a recent study from the University of Massachusetts, Amherst, showed that in a large cohort of baby boomers, what determined happiness and fulfillment was not the relentless pursuit of money, but... you guessed it, giving back to the society through such activities as volunteerism!

So, why does Glenn, being an authority on everything, from politics to science to history, worry about rampant volunteerism promoting a totalitarian system? Well, the answer is he is not. That's right, he is not. These are the same tactics traditionally used to derail healthcare reform. Remember Reagan's ads in the Truman era equating socializing medicine to a descent into the Nazi Germany and Communist Russia? These are blatant lies, but they strike at the core of our national fears. This is exactly what Glenn and his cohorts are doing -- fanning the flames of the cold war left-overs. Why? The answer to this is surprisingly simple: to keep us down.

The message of the UMass study is very clear: single-minded pursuit of money leaves a spiritual void that can be filled only by civic engagement. This thought is subversive: if the population is fulfilled, they are potentially less prone to manipulations of consumerist marketplace, and they may even see through the deception of the wealth myth (work harder to make more has not been the case in the last 30 years for 80% of the American workers). Such mass epiphany would threaten the stranglehold that conglomerates such as Rupert Murdoch's has on our national consciousness. Simply put, Glenn and other minions are terrified by these developments because their message machine will become impotent and unable to sell us the bill of goods that has so successfully kept them in style and the rest of us in painful conflict.

So, be afraid, Glenn, be very afraid! Civic involvement builds communities. Strong communities can in turn guard from yours and other media propaganda. Strong communities create healthy and caring individuals, the best antidote to your cynical attempts to keep us isolated and unhappy and unsuccessfully filling the void with plasma screen TVs, new cars, in need of ever-increasing fixes of these false gods. Strong communities are anathema to anti-healthcare reform rhetoric: if we know and care about our neighbors, the impersonal healthcare disaster stories we hear today gain a very personal dimension. In strong communities your media noise is replaced with family conversations, and children learn to respect others and themselves. This is exactly why your fears are justified, Glenn (and Rupert). In a nation starved for real values and happiness, civic involvement will prevail, and your empire of cards is sure to collapse. Good riddance!