Conflict of interest in continuing medical education

I know I've been on a conflict-of-interest kick lately, and this post will continue in that vein. I have to thank the New England Journal of Medicine for the fodder, which also leads me back to my old assertion: healthcare should NOT be done for profit.

In this week's NEJM, there is a piece from the Office of Inspector General of the US Department of Health and Human Services titled "The Agenda for continuing Medical Education -- Limiting Industry's Influence". In this article Morris and Taitsman lay out the issues and potential solutions. And while the problems are quite apparent, sensible solutions are scarce. The problems may be summarized as the undue influence by the Industry stake holders on the content of physician education. To understand this mouthful, one has to be familiar with the structure of the CME establishment.

The overseeing body for CME accreditation is the Accreditation Council for Continuing Medical Education. ACCME's stated Mission is

...the identification, development, and promotion of standards for quality continuing medical education (CME) utilized by physicians in their maintenance of competence and incorporation of new knowledge to improve quality medical care for patients and their communities.

In their 2008 report the ACCME quantified the total income for the 725 CME providers they accredit to be $2.4 billion. Who are the CME providers? According to the NEJM article, in 2007 they included

...270 physician membership organizations, 150 for-profit medical-education and communication companies, 123 medical schools, 93 hospitals and health care systems, 38 other nonprofit organizations, 15 government entities, 14 insurance and managed-care companies, and 33 providers that were not classified.

It is interesting to note that all of these organizations derive significant revenue from Industry CME funding. While most suspicion of undue influence centers around the for-profit MECCs, it is a fact that MD membership organizations rely heavily on CME funding, in addition to registration fees, to bank-roll their annual congresses. So, the idea is that, since ACCME accredits CME providers and not their programs on the ground, these providers may cater to their Industry clientele by structuring CME programs so as to optimize the chance of being funded. In other words, the relationship between CME providers and Industry is seen as too cozy.

Some solutions are offered by the authors. The one they seem to favor most is a compromise between today's mechanisms of allowing Industry to target specific programs they want to fund and the extreme of removing Industry funding from the CME space altogether: allowing companies to pay dollars into a common pool, which in turn is to be used by a third party to pay for CME programs deemed worthy and without either credit to or input from a company with an interest in the specific area being covered.

So, let's go with this solution. This means that for a private manufacturer the choice now becomes either to play in the common sandbox without any guarantee of a return on their investment (granted, even today the ROI is not supposed to enter into the CME funding calculus), or to get out of the CME funding game and invest elsewhere. If too many manufacturers should choose the latter, the whole CME game will be in trouble, and the physicians will need to pay for their own continuing education. In addition, if you think that meeting registration is expensive now ($400 to $800 in my experience), think what professional societies will have to charge once there is no Industry funding! The whole paradigm as it stands now may tumble.

I personally do not think that this solution is viable. Why not expect the manufacturers to be good corporate citizens and continue to contribute vast sums of money even without direct tangible benefits to them? Well, the answer is surprisingly simple: economic theory. The entire foundation of our capitalist free market theory is the idea of selfish utilities. Simply put, this theory maintains that people will act in their own best interests; this constitutes the rational decision making as promoted by free market economists. The fact that this is a theory that has never been put to a test does not keep our economy, philosophically and pragmatically, from being mired in greed and selfishness. What is the mission of the Boards of Directors of Industry? To generate and maximize profit. Period. Being a good corporate citizen is acceptable only as a by-product of this mission. And this is not a negative judgment of the Industry philosophy; this is the direction backed even by most liberal left-leaning economists in the US today.

OK, then why would we expect Pharma and device manufacturers to "donate" money that will not let them get ahead of their competition? We shouldn't. Having chosen to throw the dice of healthcare on the roulette wheel of free market competition, is it not hypocritical of us to ask that sector to play by different rules? Does it not make more sense to take healthcare out of the for-profit game altogether? I don't know about you, but to me the message is quite clear: by demanding a private industry to give money without an expectation of any ROI is completely at odds with the mission proscribed by free market economic theory. De-profitizing (yes, in fact, it is a neologism; any problem with that?) healthcare is the only solution that I see to remove this dissonance. This is one baby that needs to be thrown out with the bath water.

$1 million vs. a free pen

Two items have grabbed me so far today: one on your favorite contemporary intellectual (and mine) Sarah Palin, and the other on the "Democratic" senator we love to hate, Joe Lieberman. The common thread is flip-flopping of opinion in favor of ideology.

An editorial in today's Washington Post by Eugene Robinson points out Palin's complete 180-degree turn in her views on climate change. Robinson writes:

Back then, Palin was the governor of a state where "coastal erosion, thawing permafrost, retreating sea ice, record forest fires, and other changes are affecting, and will continue to affect, the lifestyles and livelihoods of Alaskans," as she wrote. Faced with that reality, she sensibly formed the high-level working group to chart a course of action.

This sober view from just one year ago is a complete antithesis to her most recent call in a WaPo op-ed to President Obama to boycott Copenhagen and to deny the "shoddy" science of climate change.

In a similar vein, the New York Times talks about Joe Lieberman's ardent opposition to the Medicare buy-in provision in the Senate healthcare bill, the opposition that now looks to be resulting in complete removal of this provision in order to get the bill passed. What is fascinating about his stance is that just a few years ago, as Al Gore's running mate, Lieberman had proposed exactly the Medicare expansion as the solution to our healthcare woes. In fact, the story contends that even a few months ago the Senator was in favor of this strategy.

So, what has changed for each of these politicians in just a matter of months to make them turn completely away from what they had believed? For Sarah Palin, as Robinson astutely points out, it is clearly her political base:

I predict we'll see more artful dodges of this kind from Palin. She made any number of pragmatic, reasonable, smart decisions as governor -- and now, it seems, will be obliged to renounce them all. Her tea-party legions have one answer -- a shouted "No!" -- for every question.

As for Lieberman, he has his own base to cater to. While the NYT reporter hints at the motivation, the Senator is given full credence in his denial of the accusation:

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. He said he favored a proposal, not included in the health care bill, that would end the insurers’ limited exemption from federal antitrust laws.

Hogwash, really? I am not so sure that I am willing or gullible enough to dismiss $1 million in contributions as hogwash. Again I have to go back to my assertions here and here that it is incumbent upon the person taking the money to disclose any real or potential conflict of interest, and let the public decide whether or how this COI may affect one's stance.

So, is it possible that both Palin and Lieberman are just blowing with their financial winds? Well, if you think that a free pen with a drug's name can alter a physician's prescribing pattern, why is it so difficult to concede that $1 million in contributions and a strong political backing may hold some sway over our politicians?

Grand Rounds is Up!

It's Charlotte's Web over at the Florence dot com blog:

Welcome to this holiday edition of Grand Rounds! It's the time of year when friends and family gather, when stories are told and memories are made. But the winter weather and short days here in the northern hemisphere seem to prompt brevity in our everyday comings and goings. It seems like the right time to combine storytelling and brevity and channel Charlotte, one of the most masterful storytellers I met during a childhood spent with my nose in a book.

Great job and thanks, Barbara!

Tinkering and innovation: You can't have one without the other

Last week I blogged about the empty black box of evidence in medicine. Afterwards I got to thinking about black boxes in other parts of our lives in the 21st century -- seems to me they are everywhere and getting more and more prevalent.

To appreciate their proliferation, we must travel back in time to around the middle of the 19th century. I know, it is a bit anxiety-provoking, what no blogging, no tweeting, no iPhones... And yet, let's persist. The landscape is still dominated by small rural communities with farming as the major industry. Around these farming villages some small local businesses are making a successful run: furniture makers, dress makers, healthcare providers. Schools are also local and classrooms are multi-age and co-ed. School day follows the agrarian cycle, allowing the kids to maximize their farm time in every season. Most goods and services are created locally, if not in the home itself. When a shovel breaks, it is fixed. When socks rip, they are darned. When a child is having trouble with homework, she is helped by her parents and siblings. Evening entertainment is provided in the home by family members' stories and the stars in the sky. OK so far?

In comes industrialization. Furniture and dress making are automated, farmers begin to move into cities and schools become more regionalized and no longer need to observe the constraints of the agrarian lifestyle. The second half of the 20th century ushers in unprecedented advances in technology. Instead of fixing our broken shovels, we chuck them and buy new ones. Ditto for socks, cars, computers, couches. We used to be able to look under the hood of our 1967 Dodge Dart and fix the strange rattling noise. We used to bring our shoes to a shoe repair shop to re-sole when necessary. Today we discard the old and buy the new model.

I know what you are thinking: there she goes again railing against consumerism! Well, yes, but that is not where I am going with this. A byproduct of our rampant consumerism is the loss of the art of tinkering. Tinkering is our legacy. What were Thomas Edison and Ben Franklin if not tinkerers? How about Steve Jobs and Michael Dell? How many of us can build or fix a transistor radio? What about next generation life-altering technologies we cannot even conceive of yet?

Along with this loss of tinkering came the ceding of expertise. What I mean is that, since everything today seems infinitely more complicated, the public defers to the expert class, built around the black boxes clearly inaccessible to mere mortals. And guess what is the biggest black box... If you guessed our educational system itself, you are correct. Reading, math and social studies have been taught in the home, then in small school houses, for centuries. (And if you think that farmers did not learn math, think again: you cannot get around a farm without being facile with things mathematical.) Parents used to know how to help their children learn. Now, we defer our children's education to "experts" behind closed doors, who are likely to recommend pharmacologic solutions where individualized approach is needed. And what has this gigantic black box yielded? If you read award-winning secondary school teacher John Taylor Gatto's angry diatribe against our educations system, "Weapons of Mass Instruction", aside from a big headache, you will walk away with the understanding that we are now, as a nation, more cynical and dumber than we were 80, 50, and even 30 years ago. Thanks to experts.

So, we in effect have given away transparency and control over most of our daily lives. Distant industrial farms provide what passes for our food, distant manufacturing plants in China deliver our clothes, furniture, computers. Locked down institutions beyond our inquiry and constructive criticism have a hold on our children for 8 hours each day, and wish to prolong this hold by contracting vacation time to do what? Produce even more pervasive boredom, cynicism and ignorance? Even our entertainment has passed into the black box realm: distant producers selling their advertisers' wares by creating inane and irrelevant "entertainment" for the masses.

People, we are no better informed than our ancestors banging their drums to ward off solar eclipse. Our fancy gadgets separating us from what's under the hood of reality give us a false sense of complacency. If we want true innovation, we need to get back to our tinkering roots. Learn to darn your socks, help your child to read and teach her to tinker, so that she can stay curious. Question "experts": most of the time the mountains of complexity behind their concepts are useless or unnecessary, or created for the purpose of exclusion by obfuscation. Throw open these black boxes and shine a light in them. Play with stuff. Play with ideas. Tinker!              

When the black box of evidence is empty

A close friend of mine gave birth a few days ago to her second child. My friend is a slight woman whose infant came out at 6 lb 9 oz, even though she was calculated to be at 36 weeks' gestation. The infant and the mom have done great with absolutely no complications.

This is why, when I was talking to the Dad this morning, I was shocked to hear that the baby had to undergo a test I had never heard of: something to do with putting the child in its car seat and monitoring its heart rate and oxygen saturation for one hour. Mind you, my youngest is 9 years old, and I had never hear of this test, so I looked it up.

Turns out, this is a test formally known as a "pre-discharge car seat challenge". I went to the American Academy of Pediatrics web site to look for their take on it, and here it is:

Hospitals should develop a policy to ensure provision of a period of observation in a car safety seat before hospital discharge for each infant born at <37 weeks' gestation to monitor for possible apnea, bradycardia, or oxygen desaturation.

I went on a circuitous journey to trace the origin of this recommendation. Turns out, it is based on a consensus statement from an APP committee from 1996, the reference for which is this paper from 1993 about implementation of the 1990 AAP recommendations. Looking at the 1990 version, however, does not help in the least, as there is no mention at all of the test in question, or anything to do with infants under 37 weeks' gestation. So, this is where the dubious evidence trail ends. Period. No evidence near as I can see. [If someone knows of a more complete statement that does include the information I am interested in, please, point me to it].

Why did I go after this piece of information? Well it seemed to me to arise out of the "more is better" fallacy, and I wanted to understand a) the evidence that led to the recommendation, b) how the test alters practice, and finally, and most importantly, c) does this practice impact the desired outcomes (i.e., prevent something bad).

So, I went to one of the most trusted sources in evidence synthesis, the Cochrane Collaborative, to see if they have examined this issue. Lo' and behold, I found this 2006 review, whose findings were summarized thusly:

There is no evidence that undertaking a pre-discharge "car seat challenge" benefits preterm infants. The "car seat challenge" assesses whether preterm infants who are ready for discharge home are prone to episodes of apnoea (stopping breathing), bradycardia (slow heart rate), or desaturation (low oxygen levels) when seated in their car seat. However, it is not clear whether the level of oxygen desaturation, apnoea, or bradycardia detected in the car seat challenge is actually harmful for preterm infants. Additionally there is concern that the use of the car seat challenge may cause undue parental anxiety about the safety of transporting their infant in a car seat. Despite these uncertainties, and despite the widespread use of the test, we have not identified any randomised controlled trials that assessed whether undertaking a car seat challenge is beneficial or harmful to preterm infants.

So, here is a kid, born at supposedly 36 weeks gestation, but looking and acting like a full-term infant, having to sit in her car seat for 1 hour to undergo monitoring that has absolutely no evidence behind it. Putting aside the inconvenience, the false positives, the parental anxiety, let's think about the costs. I could not find published reimbursement rates for this useless test. However, if you think about the person-power, the equipment used, and the potential prolongation of hospitalization that it may induce, the price tag is likely not trivial.

This case is instructive to me. As I have said before, a pitiful minority of medical practice has good evidence behind it. It is precisely this type of testing, done to comply with what looks to be a self-propagating yet outdated recommendation, that healthcare reformers in Washington need to be addressing. Furthermore, when evidence is kept in a black box, we are likely to find that the box is indeed empty.a,

bradycardia, or oxygen desaturation. An appropriate

hospital staff person should conduct the observation.

Hospitals should develop policies to

  

Evidence-based free-market economics?

Seeing as I am an outcomes researcher, I thought I'd float this question to all the zealots of free market economic theories: Have their outcomes ever been examined in an evidence-based manner? Here is what I mean.

In medicine, the highest quality evidence comes from randomized controlled trials (RCT). In these deliberately and painstakingly planned and executed studies subjects are enrolled randomly into either a treatment group or a placebo (or standard of care) group, and certain relevant outcomes over time are compared between the two groups. This design works well for drug trials, for example, but not so well for something like environmental exposure studies. Thus, in order to understand the adverse effects of smoking on health, no RCT could be performed ethically, so these data come to us from epidemiologic studies. Though deemed by the EBM community to be somewhat inferior to an RCT, they have their advantages: they can enroll more and varied patients, they are cheaper, they are more feasible to do over long periods of time, and they do not require alterations in naturalistic practice. The flip side is that we have to be more careful about introducing such inaccuracies as bias, misclassification and others, though their most important limitation as cited by some is their inability to prove cause and effect.

Putting the limitations of epidemiologic methods aside, their practicality makes them attractive and ubiquitous in helping us understand healthcare. One of the most important issues we face in EBM is understanding the risk-benefit profile of what we do. To get at this, our studies have to be planned carefully to incorporate not only the important exposures, but also the relevant, valid and complete endpoints (or outcomes). Thus, it is not enough to pat ourselves on the back by saying that a drug decreases the risk of a clot; we also have to show that this benefit outweighs the attendant risk of bleeding in the specific population of patients.

Let's apply these principles to the free-market theory. Have its advocates examined its risk-benefit profile in a scientifically rigorous manner? According to Harvard's Stephen Marglin, they have not. In his book "The Dismal Science" he makes a strong argument that economists, by pushing their free market theories with religious fervor, have undermined the very structures of our communities. Furthermore, this noted professor of Economics maintains that free market theories have never been impartially evaluated. So, there you have it: the single unifying thread of the entire Western civilization today is just as faith-based as a rain dance around a fire. So, when we talk about evidence for climate change and peak oil and how a concerted effort to mitigate these phenomena would affect our economy, let's not fool ourselves: the evidentiary standards we demand for free market's detrimental effects are much more stringent than those for its benefits, which we have essentially swallowed on faith. Hook, line and sinker.      

An executive articulates the value of his drug

Allos Therapeutics is a small biopharmaceutical company located in Westminster, Colorado, with a single agent on the market. Pralatrexate, brand name Folotyn, is a small molecule therapy for a rare and aggressive hematologic malignancy peripheral T-cell lymphoma. The recently FDA-approved drug is stirring controversy by, you guessed it, pricing itself out of the market. The pricing giants at the company decided that a fair price for the drug, achieving parity with other compounds in the space and helping them recoup their investment, would be $30,000 per month.

In the area of cancer, such a price tag is certainly nothing unusual. Here, fancy and expensive-to-produce biologic therapies can run as high as $100,000 annually to treat such common cancers as those of the lung, breast and colon, even while only prolonging the patient's life by an average of 2 months. But here is the kicker: pralatrexate is not a biologic, but a small molecule, and not even first in class! So, essentially, it is a me-too drug that is not particularly expensive to manufacture.

But let's give the company the benefit of the doubt -- after all, clinical development, especially in a rare cancer, is prolonged, costly and generally resource-intensive. A few more pieces of the puzzle are in order before we can make the final judgment. The drug was approved based on a trial of 115 patients with recurrent PTCL refractory to, on average, 3 prior therapies. The outcome evaluated was a combined endpoint of complete response or complete response unconfirmed or partial response (each indicating degrees of tumor shrinkage). Among the 111 evaluable patients the response rate was 27%, and the median duration of response was 9 months (meaning that one-half of the 29 responders progressed by 9 months). And the median duration of use of the product in the trial was 70 days.  

So, let's do the math here: if 100 patients are prescribed this drug for 70 days (this is being conservative, as the median is usually lower than the mean value in similar distributions) at a cost of $30K per month, we have spent $7,000,000 to get a response in 27 patients that lasts under 1 year, or about $333,000 per year of life saved. So, this may be less reasonable in some books than others. Hmmm...

Well, in case you you have any shred of doubt remaining, look at what James Caruso, the Chief Commercial Officer for the company, is quoted as saying:

Patients, moreover, are likely to use the drug for only a couple of months because the tumor worsens so quickly, he said. So the total cost of using Folotyn will be less than for many other drugs with lower monthly prices.

So, the message is that our expensive drug should be used not because it saves lives, not because it improves quality of life, but because the expense will be limited by the its uselessness? Isn't is a little bit like saying that a gas-guzzling HUM-V is worth the expense because it will break down in two months anyway? I have to admire the manufacturer in speaking the truth this way: if more manufacturers do this, comparative effectiveness concept will become obsolete before it is even legislatively approved.  

Gossip: an untapped renewable energy source

Just out of curiosity I Googled news on "peak oil" and got 3,397 hits. Then, I Googled "Tiger Woods", and got a staggering 57,134 hits! What does this mean?

I have spoken of peak oil before, so will not belabor the issue right at the moment. On the other hand, this is the first time the name Tiger Woods is appearing on this blog. Why? Because a celebrity's personal life is none of my business, it is none of my children's business, and none of my community's business. I prefer to engage in life itself rather than waste my time on voyeuristic destruction of another life (actually several lives).

But here is my question: how can we harness this endless and renewable resource of gossip to power our post-peak lives? Why is the Department of Energy not exploring this abundant energy source? Oh, yeah, you are right, it is toxic to the environment.

Destruction of lives in the name of cheap entertainment has become a staple of "journalism" in America. If news outlets would only focus as much attention on the real issues that we are facing as a society as they do on meaningless infotainment, we might not be a nation of overgrown adolescents habituated to a steady diet of mindless pablum. That would be pretty subversive, would it not? I wonder what it would be like if we just said "No thanks, not today. Not any longer."

The wheels of corporate journalism are lubricated by oil. What would happen if the truth came out? The bottom would fall out of the market, as all of it is inextricably dependent on oil. You can press your nose to the glass of familiar narrative of someone else's fame, fortune and destruction and be content to live in the fairy tale being sold to you. Or you can demand the truth, so that you can make your own decisions within your community. The choice is yours.  

Can US agriculture reform inform the healthcare debate?

A rather shocking analysis by an otherwise astute observer of American history Athul Gawande, MD, in the New Yorker has sent me reeling from its short-sightedness. In his article Gawande argues that the Senate healthcare reform bill is on the right track by not demanding wholesale budget controls, but rather instituting small pilot programs to see what works best. Although pilot programs may not be a bad idea, Gawande's argument is deeply flawed. It relies on the theory that the changes in agriculture and food production in the beginning of the 20th century were also characterized by small pilot programs that eventually took over the nation, bringing our food budget under control and, by reducing drastically the proportion of population engaged in farming, provided a productive work force for manufacturing and growing the economy.

Indeed, the changes in the way we produce our food that took place in the first decades of the last century are remarkable, and one can stand breathless before this edifice of modern science with unabashed awe... but only if one truly believes that this movement has been a success. And clearly, Gawande subscribes to this opinion:

The history of American agriculture suggests that you can have transformation without a master plan...

I would beg to differ, and so would many who worry about our current agricultural practices. We raise corn and soy beans as monocultures, and douse them with petroleum-based fertilizer to make them grow. The humus that Gawande talks about in his article is not considered at all in today's industrial agriculture, and the level of the destruction of the topsoil in these gigantic swaths of potentially fertile land is unprecedented. Similarly, food animals are grown in inhumane, crowded, disease-laden conditions in so-called Concentrated Animal Feeding Operations, or CAFOs, where cows are fed corn and corn byproducts. Instead of grazing in pasture and putting their rich manure back as fertilizer, thus ensuring the sustainability of the humus, their effluent now contaminates water supplies. It was only a little over 20 years ago that the world was shocked by the revelation that these ruminants were in effect made into cannibals by being given parts of other cows in their feed, resulting in the emergence of the Mad Cow Disease. I doubt that I even need to mention that because of the unhealthy conditions of the CAFOs, animals are actually routinely given antibiotics to keep them from contracting infections, a practice that scientists agree is driving the evolution of a class of superbugs that are now threatening our species.

A couple of other effects of our wildly "successful" farming apparatus are the obesity epidemic, the combined contributions of deforestation for the sake of pasture and the exorbitant amount of methane gas produced on these farms to climate change. There are also the effects of the continuing fallout of the displacement of family farmers from their communities and their connection to ancestral ways to the impersonal and demoralizing widget-making in the cities. All in the name of the economy!

So, dear Dr. Gawande, forgive me if I disagree with you on each and every point about how industrialization of agriculture has been a wonderful thing for America. I believe you, much like most pundits, are confusing the almighty American Economy with the American citizens, who certainly fade in comparison to the riches derived on their backs.

I am not fundamentally opposed to pilot programs -- they may be the way to tweak incremental changes in how we do medicine. But to rely on them as the sole fundamental tool in the reform is a big mistake. In fact, the history of the American agricultural revolution is the strongest argument there is against a transformation without a master plan. It would be tragic to be lulled into the complacency of "act now think later" at this critical cross-roads of our time.        

Why medicine is not like a parachute

At the recent meeting of the American College of Chest Physicians I went to a session on hospital rapid response teams. This was a talk given by a senior and respected member of the Pulmonary and Critical Care academic community, well published and known. Now, if you are wondering what the heck is a rapid response team, I will tell you: it is a team composed variously of an ICU physician (or a hospitalist, depending on local patterns), a nurse or two, a pharmacist and sometimes other ancillary personnel. The role of this team is to be at the beck and call of the ward nursing staff to evaluate urgently any floor patient whose clinical condition may appear to be deteriorating. The ultimate goal, of course, is to avert a catasprophic emergency called a code, where the patient deteriorates to the point of needing emergent resuscitation.

While such a team makes a lot of sense, no study has convincingly shown that it does what it is meant to do -- either prevent codes or save lives. The presenter, a man quite invested in the sensibility of such teams, was making the point that perhaps we just have not focused on the correct outcomes to measure for this intervention. Ultimately, he said, we should continue to support such teams because of our gestalt that they work. After all, he went on, nobody has tested the effectiveness of the parachute in a randomized controlled trial.

When I heard this, I realized that I had been hearing this comparison a lot lately, of medical interventions to parachutes. And since his statement seemed somehow wrong to me, I started to think about why such an analogy is completely fallacious. And here is the startlingly obvious answer: the number needed to treat (NNT) for a parachute is 1! What this means is that one only needs to "treat" one person with a parachute (or strap it on before jumping out of a plane) to save one life. Now, is there really anything that we do in medicine whose margin of effectiveness comes even close? Last week we argued about a screening test with the NNT of 2,000. And we also talked about a therapy with a NNT of 16 which is not being utilized because of high costs.

So, let's not be intellectually lazy and let's not resort to comparing anything we do in medicine to a parachute. The parachute is made to mitigate the laws of physics, which are inherently more predictable, stable and generalizable than the laws of biology. Instituting a rapid response team may feel good to us, but, in addition to lending no measurable improvements to patient care, it may have the "unintended consequences" of abandoning patients who really need our attention at that moment to better their outcomes.

A similar argument can be made about many interventions whose mere face validity we take as God's own word. We and others have cautioned against such gullibility, particularly in a world that runs with half-truths and misinformation under the banner of quality measures. None of us has the cause to be so self-congratulatory as to compare our wares to the parachute. Now more than ever, experts need to think and present critically, soberly and objectively, lest we continue the trend of parochialism in our out-of-control disease care system.    

USPSTF recommendations: Demanding manipulation from science

The recent uproar over the new screening mammography recommendations got me thinking about a lot of stuff. One of the lessons cited by some journalists and pundits is on how potentially volatile information should be presented to the public. The USPSTF was excoriated by critics not only for what it said, but how it said it. While the objections over the former can be dismissed as ravings of loud and poorly informed voices deliberately trying to hijack public opinion, the latter criticism is more insidious.

Some intelligent and balanced observers noted that the USPSTF really should have foreseen the fallout and laid the groundwork to make the sting of the recommendation less pronounced. In the corporate world this is called "making the rounds". This means that, when you have an idea, it is not enough just to present it on its merits in a group forum. Indeed, you must go around to those whose opinions matter and get them to sign on to your idea before you make it public. In this way, by furthering your relationships, you manipulate the outcome in your favor. This can take countless hours, but this is how things generally get done in the world of business.

The world of politics is similar, in that many reforms and decisions are dependent on behind-the-scenes deal-making between politicians. These clandestine transactions, the theory goes, assure the appearance of a successful outcome in the light of day. And a victory necessarily begets other victories.

Well, to be sure, science and academia are not immune from such politicking and manipulation. In fact, I have heard some assert that our academic institutions are the most politically charged enterprises, even more so than business and politics. So, in that respect, it is not unreasonable to expect some round-making prior to spilling the mammography beans. But what if we question this premise? What if we insist that science remain the last frontier shielded from political influences? I would argue that this should be our only stance on science, be it climate science or medicine. Science should be judged on its merit only, and not on its political ramifications.

In a society where business and political message machines spend countless dollars on market research surveys to package their manipulations to get us to follow their political and consumerist directions, the public is now angry that the USPSTF, a scientific body, did not take the time to effect an elaborate manipulation scheme to get the loud dissenters, and the rest of us, on board with their recommendations. Is it not outrageous that we, American adults, expect, and even demand, such manipulation instead of the straight unadulterated truth?

This is a sad reality of our time, following decades of indoctrination by marketers, educators and other "experts", to become compliant little consumers that we are today. How easily we are stirred into a rage by callous reporting and special interest demagoguery is telling. We are a mirror-mirror-on-the-wall society: we will not tolerate any truth that does not fit our conveniently preconceived notions of specialness and entitlement. And while this attitude gives us a peaceful soporific feeling one gets following a psychotic rage, it will make it that much more painful when this consumerist fog is replaced by the reality of shortages, as our cheap energy supply dwindles. Unfortunately, by then, it will be too late for the truth to set us free.

There is still time, though! Turn off the television, stop listening to and reading mass-produced messages designed to make you a quiet lemming on its way off the cliff. Focus closer to home, build your local community. And, yes, talk to your doctor about your mammography concerns -- you will surely walk away with a more satisfying conclusion and a feeling of self-determination.

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%