What does $750 billion in wasted spending look like?

Here is an infographic (I know) from the Institute of Medicine who just released this report. According to it, we are wasting $750 billion annually in unnecessary healthcare costs, and here is the breakdown. Note the ~$250 billion on overdiagnosis and overtreatment. Now,what are we going to do about it?

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Blind and toothless: The future of middle class in America?

Since it's Friday, we'll steer clear of academic subjects and just tell a story. This is a story of a good friend of mine who works in an editorial position for an interdisciplinary humanities journal. This journal is based at a prestigious private liberal arts institution, and thus she is on staff at that institution. This story is about her, but also about how well the Massachusetts health law is working for people like her. I will call her Jo.

Jo is in her early 50s, a single mom of two lovely teenage boys. Their father who is separated from Jo, although in the picture, does not provide any child support for various reasons. Thus she carries sole financial responsibility for her family.

Well, you say, she is on the journal's editorial staff, she is loaded, right? Nah, surely you are not so naïve as to think that this is a high-paid position at a humanities publication. Let's just say that she is not the 1%; why, she is not even in the top one-half. Would you believe me if I told you that a high-ranking editorial staffer gets a salary that is only 2x above the federal poverty level threshold? So much for those wealthy elite academic East Coast types! But she does get her healthcare insurance through her employer, and this is fortunate, right? Well, here is the rub.

Jo has a complex health condition that affects her entire body, including skin, teeth, eyes, heart, lungs and viscera. Despite this, she is optimistic, upbeat and one of the most patient parents I have ever met. But here is what gets her goat: it is the very fact that she gets her health insurance through her employer! How can this be?

Here is how. The cost of her basic restrictive HMO insurance through her employer is over $5,000 per year. And this flat rate is not affected by the salary level of the employee; in other words, the janitor and the university president get to pay the same amount of money for the same plan. In addition to this, her office visit copay is $20, and her medication co-pays are between $10 and $30 for a month's worth of medication. As you can imagine, for someone with a complicated chronic condition, these co-pays can add up quickly, and they do, to a shocking $2,500 per year. And this is before any allowance for the boys' medical needs or dental or eye care for any of them. Once you add everything up, Jo spends over 1/4 of her entire not-so-stellar income on healthcare. But if we do add dental and eye expenses into the mix (remember, her condition affects these organ systems as well), her healthcare expenditure comes to 40-50% of her annual income! And this is just for draconian restrictions of an HMO! AND, this does not cover all of the time that she spends on the phone finding providers that take her insurance and on schlepping miles away to see that single specialist that the HMO will pay for.

But wait, you say, you live in Massachusetts, the land of socialism, gay marriage and healthcare for all. Why can't she just dump this lousy and expensive employer-provided coverage and go to the Mass Connector, where everyone is equal and all get what they need for what they can pay? And furthermore, you say, isn't the PPACA, the new healthcare law of the land that is fashioned after Romneycare in MA, going to take the choice away from people and MAKE them get insurance through these exchanges rather than through their employers? Jo must be an idiot not to be taking advantage of this communist healthcare state! Hmmm, let's see now.

Jo has had a number of discussions with the staff at the Connector. And yes, you are right in that, if she switched to one of their plans, she would qualify for a plan very similar to her present one for about 1/5 of what she pays now. And the co-pays? Why those would shrink to $0 to $10. How's that for a deal? But here is the catch: According to people she has spoken with at the Connector, a person who has health insurance offered through her employer is not permitted by law to take advantage of the Connector deals if the employer plan offers coverage that meets the minimum standard in the law. And hers does. Ironic, isn't it?

So Jo goes on struggling with the financial burden of her crappy and expensive employer-provided insurance, only now she has to pick and choose: Can she afford to replace her failing dental bridge ($4,700) or should she just choose something so frivolous as feeding her children instead? This is a choice that is not a choice at all, is it? And if these are the choices that we can expect with the PPACA, well, then, we have the law that we deserve: one that will make sure that the investors in the "healthcare" marketplace continue to get handsome returns. But start getting used to people who cannot see their computer screens showing up to work without their teeth!        


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How I fell in love at TEDMED

Over the exhilarating four days this past week, we all fell in love a little bit -- with the city, the Center, the meeting, the ideas, and one another. The city was Washington, DC, a touch past its cherry-blossom blush; the meeting was, of course, TEDMED. The ideas were of about honoring our health, environment, food, and about making health and healthcare efficient and kind for all.

I fell in love with dreamers. Though their dreams were varied, their paths to fulfilling them all converged into the same stream. Like a trip down the Amazon that the biggest dreamer of all, Jay Walker, the curator and the force behind the meeting used as a metaphor for TEDMED 2012, they accepted their tortuous and demanding journeys and, much to our delight and benefit, made a stop at the Kennedy Center. And although I will only mention a few, many others will stay with and inspire me for the months to come until TEDMED 2013.

I fell in love with Bryan Stevenson, who spoke about his grandmother and identity and justice.

I fell in love with Rebecca Onie, who, while transforming the care of the urban poor is also transforming the face of student activism.

I fell in love with Traces, a Montreal performance group who made my heart stop with their daring acts of precision. Our healthcare system can learn a lot from these young people.

I fell in love with Jacob Scott and Sandeep Kishore, both of them young, energetic and passionately committed to changing the face of medical education.

I fell in love with Ed Gavagan, who told the story of his confrontation with death with courage, humor and honesty.

And yes, I fell in love with and was made to weep by Robert Gupta's transcendent violin and Stephen Petronio's defiant vulnerability.

TEDMED 2012 was a feast, and now I am back to the journey of my real life: calls to make, e-mails to return, analyses to do, papers to write, talks to give, a book to get to market. It all seems just a little drab compared to the four days I spent in this intellectual and emotional climax. But like a great yoga session, TEDMED was restorative, rejuvenating, and remarkably inspirational. The mix of hard core science, the arts, history and frank curiosity sparked personal ideas and renewed personal commitments to executing my dreams for a better society. Spurred by Sekou Andrews' and Steve Connell's raw poetry performance, like a youngster in love for the first time, I am ready to GO! So I am off to do what E.O. Wilson suggested a scientist needs to do: think like a poet and work like a bookkeeper.              

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Infographics: devil in details

I got an e-mail yesterday asking me if I would be interested in displaying an info graphic on my blog. After a few back and forths, I decided to do it. After all, a picture is worth a thousand words. But as with everything, buyer beware: the devil is in the details.

A couple of caveats:
1. I cannot back up all of the numbers myself, and the references at the bottom seem to represent single source data, rather than the totality of the evidence. So take with a grain of salt.
2. There are a couple of notable errors in the graphics:
a. The graphic on other first world nations' spending says that the US spends 2x what they do in Japan. What the graph shows is that this is the case as the proportion of the GDP (also the x-axis is not labeled as such). So, the statement is not entirely accurate.
b. In hospitals overcharging, the caption states that hospitals charge 200% more for meds compared to ex US. The number adds up to 100% more, which is 2x.
3. In general, there are actually some valid reasons why we pay more for stuff in the US. I do not, for example, know if the international data are adjusted for various economic factors, such as purchasing power.
4. The statement that doctors are overpaid is a laugh -- take it from someone who has been in the trenches. I worked dawn till dusk and beyond, nearly every day of every week. I was making barely enough to keep food on the table and a roof over our heads. No lavish vacations, no BMWs, etc. It is not the MDs that are overpaid. Go to the C-suites and corporations, and then you are getting warmer.

Despite the disagreements that I have with the data, I thought it might be a good point of discussion. Would love to hear your thoughts about it.


Created by: Medical Billing and Coding Certification
 
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Why the PPACA hearing is the very definition of insanity

I haven't said much about the SCOTUS hearing of the PPACA, but it is time to break my silence. I have been listening to some of the details of the arguments, and I cannot help but be nauseated. It feels to me like the Justices are behaving like my teen: they take literalness to its absurd limit. Health insurance and cell phones, really? This betrays a complete disregard for probability. What are the chances that you will within your lifetime in the US need to dial 911 in the absence of a landline or another human with a cell phone within shouting distance? And what are the odds that you will at some point in your life require a medical consultation? I rest my case.

The more I think about it, the more convinced I am that the bill should have introduced single payer a priori -- funding our access to medicine through a tax. Yes, a tax. Perhaps the government is not the most efficient agent of this, and the overhaul could have been accomplished through some public-private hybrid model. In the end, as I have said here, our priorities are misaligned, as are our perceptions of what is important in this debate. We spend 97% of all the healthcare money on medicine, and we spend well over 97% of our national discussion about health on access to healthcare and medical interventions, which can only make a 10% difference in our health. The real money, so-to-speak, is in public health, which contributes 60% to our true health and gets only 3% of the expenditures and practically no conversational energy.

So, once again I find myself turning to the wisdom of Albert Einstein, who defined insanity as "doing the same thing over and over again, and expecting different results." The SCOTUS circus is the poster child for this insanity. Whatever the outcome, and I am not at all optimistic about the individual mandate, my sense is that nothing will change until we start paying attention to the root causes of our collective illness.

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How our healthcare spending is like that drunk joke

You know that joke about the drunk crawling around under a street light? A cop comes up to him and asks what he is doing. The drunk explains that he is looking for his wallet. The cop, getting ready to help the man, asks where exactly he dropped it. The drunk points to a distant corner of the dark side of the street. The cop, baffled, inquires why the man is looking here. With inimitable logic the drunk responds, "This is where the light is."

What does this story have to do with anything? Well, I went to a great HIT tweet-up in Cambridge yesterday, organized by Scratch Marketing and led by Janice McCallum. No, they did not at all remind me of the drunk in the joke. But the lively discussion about data by about two dozen attendees inspired by Janice's thoughtful presentation certainly made me realize that our healthcare policy is like that drunk. Here is what I mean.

Our healthcare expenditures are completely devoid of any attempt at probabilistic thinking. I thought about the old Rand Corporation data, which I have presented here before. Juxtaposing them with the data on our National Healthcare Expenditures really drives home my message that we need to get a whole lot better at applying probabilities to our decisions. And this specifically applies to policy.

Just look at the glaring imbalance: while fully 60% of all premature deaths are due to behavioral, social and environmental factors which reside in the realm of public health, 97% of all NHE is spent on the medical side. If I add the 2% of the total NHE spent on research into the public health piece of the pie (this is exceedingly generous, as public health research gets a bafflingly tiny portion of the total US research budget), we still have 95% spent on personal health and its administration and only 5% on public health. 

So, if the probability of premature death due to a public health-related condition is 60%, why are we only spending 3% of all the healthcare dollars on fixing it? Another way of posing this question is, if the probability  of premature death from issues related to access to adequate medical care is 10%, why are we spending 97% of all the NHE on that piece of the pie?

If this isn't just like that joke, I don't know what is. Only in this case it is much less funny than in the case of the drunk.



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A good week

So, it has been a great week here at Healthcare, etc, and I am grateful.  Here are the highlights:

1. I did a guest post on plagiarism at Retraction Watch, and not only did it generate a fantastic conversation there, but it also brought other stories of plagiarism to us right here on this site. The story is not finished, and I will update when I can.

2. Gary Schwitzer of Health News Review cited 2 posts from Healthcare, etc. on his extremely popular and well-respected site here and here. The corresponding stories that he referenced were "Unpacking the meat data" (which incidentally is the most popular post of all time on this blog) and "PSA screening: Does it or doesn't it" (a niche post with a lively discussion in the comments).

3. The crowning glory of the week was being cited by Mark Bittman in his New York Times column on May 16th, which drove hordes of readers to Healthcare, etc.

4. Finally, my book is progressing through editing and design, and it is all beginning to seem more real. It feels like I am realizing my dream of bringing a critical approach to evaluating medical evidence to all who are interested. If you want to get news about it in your inbox, please sign up here.

In the next few weeks you can expect to hear about my experience attending and presenting at the Ignite Boston conference at MIT on March 29, as well as coverage from TEDMED 2012 in DC, which I am thankful to be attending as a Frontline scholar.

Thanks again to everyone for visiting, tweeting, linking and sharing in all other ways. Looking forward to seeing you here again.

Time to get the goblins out of our healthcare system

Just when you thought you could predict my blog topics, I am going to foil you and not do a post on the rice study in BMJ. I feel like after the last two days with the "meat kills" and "PSA screening saves lives but does not reduce mortality" posts you are not only fed up, but also competent enough to do your own debunking. Let me know if you need any help with that, by the way.

No, in honor of Friday, I will do a fluff post about a show that my family and I are hooked on. Yes, we are addicted to the BBC series "Merlin." Guess what it's about. The new twist is that it is set when both Merlin and Arthur are young men, and it is Merlin's job to keep Prince Arthur from succumbing to his enemies or to his own folly, so that he can lead Camelot forever and ever amen. It has everything you would expect: castles, bloody sword-fight scenes, dragons. Its heroes and villains are an epidemiologist's dream, since they are all evil or all good with nothing in between. It has magic, though that mostly stays in the closet, as Arthur's misguided father King Uther is quite magic-phobic.

Well, last night we witnessed a first in the Episode 3 of Season 3 -- a mischievous goblin got inadvertently released from his lead-lined wooden box and invaded the body of the court physician and Merlin's mentor and friend Gaius. As we all know, of course, goblins are hungry for gold (almost literally -- you'll have to watch the episode). Normally a caring and reasonable man, the pillar of his community, the elderly physician became a raucous and self-centered party animal in search of gold coins at all costs, so-to-speak. In one scene while making a house call to a sick peasant he indicated that the man would die without the potion that Gaius was holding in his hands. Yet he would not part with the potion unless the sick man and his wife produced a gold coin as payment. "But we are so poor," the family explained, " and you have never charged us before." Well, the new and improved market-driven Gaius could not be swayed, and the family ended up giving up their meager wealth to "cure" the husband, who incidentally was merely suffering from a broken rib.

In the next scene, in his continued search for gold coins, Gaius-come-goblin is accosted by Guinevere (in this version she is merely a servant to Lady Morgana -- long story), who is suffering from some ill-defined but clearly innocuous symptom. He takes this opportunity to sell her a potion without which he claims she will succumb to the deadly infection that is gripping Camelot. And despite her obvious skepticism, she is so driven by the fear of the "what if," that she hands over her coin for the tonic and peace of mind.

If all of this seems familiar, but you just can't put your finger on how, I'll give you a hint: our US healthcare "system." It's like there is a goblin in it, who in his relentless pursuit of gold is bankrupting the nation and disease-mongering to increase profit. Of course this allegory has no nuance, and why should it: this is after all a TV series about a magical medieval kingdom whose name itself has come to mean "utopia." Yet it is jarring to realize just how close to our reality this story is.

I am sure you are all anxious to find out how the episode ended. Did the peasant survive? Was Gaius able to regain his body? Did the goblin get back into his box? For answers to all these questions you can go to Netflix. As for our healthcare system, isn't it time we chased the goblins out?

Three central questions about medical technologies

Every day my inbox gets filled with announcements for and invitations to attend all kinds of conferences. While many of them are of the traditional medical education sort, more and more I hear about meetings where new technologies and gadgetry in healthcare are the focus. And while the former feature healthcare professionals speaking medicalese from the stage to rapt audiences of other healthcare professionals in dimly lit halls, the latter capture their audience' imaginations with the promise of the future, in all its glitter and glory. And naturally, the latter are what attract techies and patients alike, steamrolling over our staid medieval medical conventions. I heard that the HIMSS conference in Las Vegas last month attracted 37,000 attendees! And the excitement was palpable even through Twitter feeds. This is clearly the preferred way to effect public engagement with healthcare.

But here is the thing: medical advances happen much more slowly than the speed of technology development. That is why, year after year, we go to our professional society meetings and have deja vus all over again. Year after year we hear the same people present the same studies, sometimes, if we are lucky, with a slightly different twist. The last group of breakthroughs I heard about at one of our critical care meetings was over a decade ago. And we have had to backpedal from that quite a bit with the removal of Xigris from the market, and with the realization that tight glucose control had to be used with extreme caution, so as not to kill more critically ill patients than it was meant to save.

This disconnect between the glacial pace of true progress in the clinical sciences and the lightening speed of technological progress raises some obvious questions about our assumptions. If we are not making dramatic breakthroughs in medicine every day, what is this breakneck pace of technology innovation delivering, save for the glitter and a seductive promise of health and wealth? Is there evidence supporting this promise? You might counter by saying that we have years, maybe even decades, of translational catching up to do, bringing all the advances from the bench to the bedside. I would have to say that the magnitude of such advances, as well as clinicians' resistance to them, may have been overstated. You might also point out that the vast advances in computing capabilities have not penetrated sufficiently into our healthcare system, and there I cannot disagree. But whether bringing these advances into clinic without careful planning will improve our health or our healthcare finances remains in question.

Moreover, I see numerous downsides to rushing ahead without thinking through what we are rushing toward. Ostensibly, the light at the end of this bright technological tunnel is better health. What concerns me is that the journey has become a sort of an end in itself: the sheer beauty of the tunnel has itself become the prize. To regain our compass, we need to ask three tough questions, each of them central to understanding the impending advent of too much out-of-context information:
1. Do we really want to walk around with sensors (pdf document, see page 16)? Personally, I find 24/7 monitoring of our vital functions to be a depressing prospect. Furthermore, I sincerely doubt that this is a better (or more cost-effective) way to achieve health than through focus on public health and socioeconomic equity.
2. What is the use of having your genome in your pocket?
How is that going to help us at the stage where all we can do is identify certain levels of risk (bracketed by broad intervals of uncertainty) in isolation from all the influences that modify that risk?
3. Do we want an epidemic of false positive findings and pseudo-disease?
We have enough trouble interpreting positive findings from medical screening tests. Do we really want the public falling prey to the anxiety and over-testing that false positives bring? As a healthcare system, can we sustain such an avalanche? As clinicians are we able to mange these screening snafus?
(I have done so many posts on this issue that you can barely navigate this site without stumbling over their debris).

All of the above is not sexy or shiny, and it brings in the ugly four-letter word "risk" to balance the discussion of the holy grail of benefit. So, how do we sell it to people so hypnotized by technology? I am asking this question quite seriously. I, and many of you out there, really would like people to become more cognizant of these nuances, but how do we accomplish this? Do we need to change our byzantine approach to medical meetings to start attracting a broader audience for our messages? If so, let's get started. Perhaps other forums that are already exceedingly successful can teach us how. I commend TEDMED (which I am attending as a Front-Line Scholar) for starting to bring this important viewpoint to their audiences. Now, how about having HIMSS, Health 2.0 and others join to clarify this other edge of the medical sword? Perhaps we can prevent the wild pendulum swings by thinking things through now. And think how much more credibility we all will have if, by thinking and debating now, we minimize the unintended consequences later?                            

Teach one thing, or the rule of thirds

When I was a medical student, I did a lot of rotations at the Boston VA in JP. I loved my patients there -- they were patient and kind and stoic. One of the best rotations I did was Hematology, where Lou Fiore was my preceptor. Lou was not only an excellent teacher, but also a terrific doctor and a good human being all around. He used to start our days together by saying, "I'm gonna teach you one thing today." And teach us he did, at least one thing per day. Now I teach. And on occasion I have used the Lou Fiore "I'm gonna teach you one thing today" promise. Well, today is one of those days: I'm gonna teach you one thing.

And here is that thing. I am sure I am not the first one to notice this, but I still think of it as the "Zilberberg rule of thirds." The gist of it is that, for clinical research purposes, one can think of patient populations crudely in thirds: there is one third who are too sick to benefit from any of our interventions, there is one third who are too healthy, so that no matter how we try to tweak, their outcomes will not change, and the middle third, which comprises the "sweet spot" for intervention. So it is a fool's errand to pursue proof of concept studies in either of the bracketing thirds, since it is only the middle third that is likely to show a signal.

Pharmaceutical manufacturers do not always appreciate this trichotomy. Look at Vioxx, for example: when used in patients who were essentially healthy, an unacceptable safety signal arose that drove the drug off the market. Same for SSRIs, where the ill-conceived enthusiasm for treating marginal depression cases seems to be debunking the entire serotonin hypothesis. The flip side is sepsis research: septic shock patients are so far gone that it is difficult for any single therapy to alter their outcomes. Just look at the Xigris story, as well as myriad other therapies that tried and failed. This is the rule of thirds at its most pronounced.

In HEOR the rule of thirds holds as well. To prove cost effectiveness the following questions need to be asked:
1. Is the disease in question prevalent?
2. Is the economic impact of the disease known and substantial?
3. Does the diagnostic/therapy in question alter the course of the disease in such a way as to be significant?
If the answer to any of the questions above is "no," you really need to think carefully about the value proposition.

Some of you will bring up the inter-individual differences, the heterogeneous treatment effect, etc. And yes, these are supremely important. However, though the framework I propose here is simplistic, we have to start somewhere. To be sure, there is a more nuanced approach to this beast, but generally, one will not go wrong by asking these questions before committing huge resources to a project, particularly if the answer to question 2 or 3 is a resounding "no." So, even in health economics it behooves one to know the Zilberberg rule of thirds: choose the right population where the diagnostic/therapeutic advance and its costs can be justified by a substantial gain in the outcomes.

And that is your one thing for today.    

3 ways to sink a new drug

I don't just rant about methods and evidence -- in my work life I also rant about health economics and outcomes! This is why I was so interested in this post by the health economist Ulf Staginnus called
"New Models for Market Access." I want to give a hat tip to Healtheconomics.com for pointing me here.

The thesis of the article is that we need to refocus our discussion from market access to true innovation in the biopharma sector. There are some priceless quotes here, like this one, for example:

It is amusing, at least to me, to see the continued flood of articles, consultant presentations, blogs, congress announcements, workshops, summits, reorganizations, speeches, etc. all over the place, basically suggesting how the industry just needs to throw a few more people with fancy titles here and there, coupled with slight organizational changes, onto the problem and involve stakeholders and—guess what?!—actually talk to patients and perhaps even payers and all of a sudden, like Alice in Wonderland, everything will be good, after all.

The uncomfortable truth is, it won't be. All this “noise” is only good for one thing, paying the bills of the consultants, which is fine, too, as I have been one myself so I can understand. But it will not address the problem the research-based pharmaceutical industry and its employees are facing. Without a substantial increase in R&D productivity, the pharmaceutical industry's survival (let alone its continued growth prospects), at least in its current form, is in great jeopardy.

Don't you love it? It is hard to disagree. He also calls for more of a focus on the long-term returns than the short-term (duh!), as well as more internal honesty, or having the courage to stand up to the pathologic internal enthusiasm about a late-stage product that will obviously go nowhere. And all of this is on target.

He has this to say about health economics and outcomes and such:

Of course, you need experience in areas such as HE, outcomes research, pricing, economics, policy, advocacy, etc. and all needs to work in sync and early on and with the payer in mind and, yes, most people have understood that by now. So the problem is essentially not in the capabilities, although some are more advanced than others, but rather in the company cultures.

And this, I think, is where I have to disagree with him. In my experience there are glaring deficits in the approach to HEOR within biopharma, though of course there are exceptions to the rule. It starts with the fact that disease burden, and especially its costs, are initially assessed through less than, shall we say, rigorous methods. I have seen this critical information get pieced together through market "research", where 5-10 "thought leaders" are asked for their opinions, and the quantification is based on this tiny non-representative sample of nothing more than guesses. This is a shame because the data usually exist which can give a much more bona fide estimate of the extent of the problem.

The second problem is that articulating the value proposition of a nascent technology is usually an afterthought. In fact it is self-evident that drug pricing must be fed using the information on the burden of disease, and the impact the new technology can make in mitigating such burden. Unfortunately, time and time again I see companies backing into a price simply in reaction to what their Boards perceive the returns should be. And frequently this is based on the overly optimistic market projections flowing from, you guessed it, market "research."

So, the direct result of all this short-sightedness and business as usual is that even innovative useful products are driven into oblivion because there is no realistic look at what the technology is worth or where best to use it. And fixing the problem after the drug or device is on the market is a much bigger challenge for several reasons. First, the acquisition costs of new technologies are bound to be higher than of those already in use. This puts them at a disadvantage in that they get niched into populations that have much greater burdens of illness and therefore less of a chance of doing well. In other words, they are used as a last ditch therapy, which very rarely ends well. Ironically, these are usually not the populations who were studied in the pre-approval studies, and thus the use turns out to be off-label. But here is the real problem: When these technologies are in the "kitchen sink" category, they will almost always end up looking worse in terms of the outcomes than their older counterparts. And to the untrained eye, or an eye who does not have the time to discern the truth, particularly in the setting of perceived high expenses on the new product, this rings the death toll for the drug. But the reality, of course, is that the abysmal outcomes are the result of confounding by indication, where the drug was inappropriately given to those patients who were very unlikely to benefit from in the first place. But you see how this early lack of attention to the articulation of appropriate populations and health economic data can snowball into failure of a promising therapy.

So, if you want your drug to fail, do the opposite of what I recommend below. In other words DO NOT
1. Develop your market understanding
Do it not from the opinions of a handful of "experts" -- experts will rarely tell you the truth. Instead, do epidemiology studies to understand your population and its subpopulations so as to get the most reasonable idea of the disease.
2. Start thinking about the value proposition early 
At the end of a successful Phase 2 program is a good time to do this. The surprise to most companies is how little HEOR studies cost in comparison with their clinical trials program. Yet, as you can see from above, this drop in the ocean can make or break a product.
3. Focus on transparent pricing methods
When pricing the technology, be very very sure that you have all of the ducks in a row, meaning:
                    a. do understand your market 
                    b. do understand the burden and costs of the disease
                    c. do understand how your product impacts these costs
                    d. do price the product to reflect this balance
It is truly embarrassing to have to admit that your price reflects nothing more than the greed of your investors. Trust me, you will not score points with your customers.

Staginnus makes one other important point which I generally agree with:

And let's face it, if you need a major workshop and intensive external “coaching” to help define the value of your product … well, there actually is little to none. If it was really good, it would have been obvious from the start. So maybe we ought to stop beating around the bush and move on if there is nothing to be done anymore. 

There is a nuance here, however, as in most things. Given what I have said above, products are more likely to gut than sell themselves. So, while I agree that you do not need a throng of consultants in suits and hair gel to pollute your offices, you do need to understand how to articulate this value, even when it appears obvious.

          

Clinician as the Politbureau of medicine?

Do you think that medicine in the US is centralized? I do, but not in the way that we generally understand centralization. And furthermore, it is this centralization that I believe is making the idea of shared decision making so intimidating to some. Here is what I mean.

If you read management texts, centralization refers to an organization that is run predominantly top-down. In other words, a couple of oligarchs at the top of the ladder make all the decisions without consulting anyone below. In this way all the power is concentrated in the hands of the few. In an antithesis to this, in a decentralized organization, grassroots input and initiatives are incorporated into the fabric of the organization. And while in the times of a great crisis, when rapid decisions are necessary, the benefits of centralization may outweigh its risks, during normal day-to-day operations, such unilateral power can result in obviously negative consequences, from discontent among the employees to making the wrong choices. Furthermore, as organizations grow in size, it gets that much more difficult to run them effectively within the centralized paradigm.

Now, let us look at medicine. The traditional model of the doctor-patient relationship relies on the clinician to know what is right for the patient: take this pill and don't worry about the side effects, dear. Now, clearly, when someone shows up to the emergency room in septic shock, there is very little room for a democratic process; we want the doctor to do rapidly what needs to be done to save the patient. But this is a catastrophic exception to the rule of what modern medicine cares for. From pre-diabetes to pre-hypertension to "borderline cholesterol" to osteopenia to mild depression, these are the "diseases" that are prevalent in the office of the 21st century. None of these is particularly urgent or life-threatening. And if we are honest with ourselves, even a devastating diagnosis of cancer does not demand an instantaneous intervention: in the vast majority of cases there is ample time for discussion and contemplation. So, the centralized approach is the wrong way to go. Thus enter the robust discussion about shared decision making. 

Another reason that centralization of medical decisions is crumbling is the expanding patient panels that clinicians need to engage with in order to stay solvent, all within the context of increasing compliance and regulatory burdens along with decreasing reimbursements. Without an equal growth in one's cognitive ability to multi-task, this escalating imbalance is creating a rising risk for unilateral decisions to be plain wrong.

So, in my mind, this is yet another argument for all parties to embrace shared medical decision making to the extent we as patients are willing and able to do so. Because what is the alternative?          

The price of marginal thinking in healthcare policy

I find it fascinating how our brains have this propensity to latch on to what is at the margins at the expense of seeing the bulk of what sits in the center. This peripheral only vision is in part responsible for our obscene healthcare expenditures and underwhelming results.

I have blogged ad nauseam about the drivers of early mortality in the US. In one post I reproduced a pie chart from the Rand Corporation, wherein they show explicitly that a mere 10% of all premature deaths in the US can be attributed to being unable to access medical care. The other 90% is split nearly evenly between behavioral, social-environmental and genetic factors, of which 60%, the non-genetic drivers, can be modified. Yet instead of investing the bulk of our resources in this big bucket of behavioral-environmental-social modification, we put 97% of all healthcare dollars towards medical interventions. This investment can at best produce marginal improvements in premature deaths, since the biggest causes of the effect in question are being all but ignored.

A couple of other striking examples of this marginal magical thinking have surfaced in a few recent stories covered with gusto in the press. One of the bigger ones is the obesity epidemic (oh, yes, you bet it was intended), and its causes. This New York Times piece with its magnetic headline "Central Heating May Be Making Us Fat" entertains the possibility that because of the more liberal use of heat in our homes we are no longer engaging our brown fat, which is a furnace for burning calories. And this is all well and good and fascinating, in a rounding out sort of a way. And it is just as interesting to hear that lack of sleep may be contributing to our expanding waistlines. But it is also baffling that we are still expending these enormous amounts of energy (OK, this one was not intended) on finding the silver bullet, when the target is not a supernatural being, but a super-sized expectation. Is it really that mysterious that we are fatter now than we were 20 years ago, when our current portion sizes are 70% bigger and we spend our days worshipping at the temple of the screen, in all its manifestations? While I am all for learning as much as we can, what we need right now is immediate action to abrogate this escalating epidemic, and I think we can all agree that the way to do it is not through lowering house temperatures. Plenty of behavioral research is available to inform our strategies to get people to eat less and move more. Let's start translating it into practice rather than latch on to one marginal magical idea after another.

And finally, I have to touch upon lung cancer, of course. The current fodder for this was provided by the Washington Post with this story about the growing advocacy among lung cancer patients for early detection. You may recall that recently I did several posts on the heels of the large NCI-sponsored study National Lung Screening Trial (NLST) whose purpose was to understand whether early detection of lung cancer in heavy smokers may improve lung cancer survival. I do not wish to go into all of the specifics of this study and my interpretation of the results -- you can find my thoughts on this study in particular and on screening in general here. What I do want to reiterate is that 85% of all lung cancer is caused by a single exposure: smoking. And guess what? The same behavioral strategies that can help people stop overeating can be deployed towards smoking cessation. Yet, instead of spending 85% of all expenditures on smoking cessation efforts, we prefer to allocate it to early detection. My point is that we need both, but the balance has to be informed by pragmatism, not the marginal magical thinking.

And so it goes that the Pareto principle is bleeding into our healthcare policy decisions -- this is the steep price of the marginal magical thinking. What will it take to get the blinders off and face up to the idea that some intervention points are just more impactful than others? Marginal panaceas will improve our lives, but only at the margins. And without being addressed, the big elephants in the room are likely to stampede us.

SoMe in medicine: It's about communication, stupid!

My generation of doctors was almost proud of its paternalistic overbearing know-it-all archetype, with the my-way-or-the-highway attitude to patient care. Even today there are inter-specialty fights in medicine that demonstrate these entrenched and seemingly fundamental, albeit willfully exaggerated, differences of opinion and clinical approach. It used to be, and still is to an extent, a badge of honor for an internist to disagree with a surgeon, for a pulmonologist to recommend a course of action diametrically opposed to that suggested by the infectious diseases specialist, and for everyone to disparage neurologists (apologies to my neuro friends). The extent of the discussion with patients as modeled by some of my senior colleagues was to say "You have this, and I am giving you this prescription, and see you in 2 months." And even today, I have observed the best of doctors still respond to a cogent "why?" question from a patient with a "because this is how we do it" answer.

My peers' lack of communication skills is the stuff of urban legends. Yet here we are at what seems like a pivotal moment for so many aspects of medicine -- science, healthcare system, communication technologies -- where effectively communicating outside the profession is a make-or-break proposition. Along these lines, in this BBC documentary Sir Paul Nurse, the head of the Royal Society, examines the societal forces that are coalescing to bring "Science Under Attack." The unifying message that comes out of his inquiry is that other less informed parties with political agendas are co-opting the discussion. Yet there is a distinct lack of the antidote of countervailing communication by scientists in terms that are understandable to the lay public. Nurse's battle cry is that scientists need to do a better job communicating their craft themselves, and not just to each other.

In some ways the prevailing elitism of medicine in the 20th century set the stage for the backlash we are experiencing today. The erosion of trust in the profession, commodification and consequent devaluation of medicine, while multifactorial at their root, could no doubt have been mitigated with better communication. Yet, great communicators rarely choose medicine as the path.

And this brings me to the contentious topic of the role of social media in medicine. For many of the early adopters, the question is no longer "should we", but "how best to." But my sense is, that physicians engaging in social media are still a minority. I am not even sure what proportion of MDs are amenable to communication via e-mail with their patients, though these data may be out there. So, for what seems to me as the majority of MDs who are not sold on e-mail, Twitter, Facebook, blogging or Quora, the value must not be that obvious. This makes me wonder if there are certain unifying characteristics of these docs, one being lack of perceived value of communication outside the profession across all media, including in-person contact.

I am friends with many docs on Twitter and in the blogosphere. The vast majority of them have shown themselves to be patient-centric, knowledgeable and collaborative, the kind of people I would not hesitate to send a loved one to. Yet, this is a skewed sample born out of a selection bias. These are the people who are interested and confident in their ability to communicate outside medicine. These are the people to whom medicine is a humanistic pursuit, where communities of patients and doctors strengthen the discussion of how to transform our system and the patient encounter. My guess is, and this is purely unscientific, that many of those who are skeptical of social media are also skeptical of communication itself, or just do not see the value of it in the equation of providing good patient care within the crushing time constraints of today's healthcare.

So my point is this: before social media tools can be expected to diffuse broadly into the medical community, the value of all communication needs to become clear to physicians in general. At this moment of increasing societal skepticism of science and of usefulness and integrity of the medical profession, against the backdrop of healthcare changes and increasingly unfiltered media noise, willingness and skills to communicate clearly may be as useful to today's doctors as a stethoscope. Once communication becomes the backbone of all medicine, tweets and blog posts are sure to start flowing freely from the fingers of physicians everywhere. And that will be good for the patients, the science and the healthcare system.

1,000 lives per day or 45 lives every hour

In the wake of the recent studies confirming our suspicions that we are no better off today than a decade ago as far as the safety of our healthcare system is concerned, I have been doing a lot of thinking and writing about this issue. The other day I blogged about the fact that there are no simple solutions, yet we must pursue change. Today, this e-mail from 350.org really stopped me in my tracks:

Dear friends,
Climate negotiations can seem quite abstract sometimes.

I'm here in Cancún, Mexico, where UN delegates from around the world spend hours debating details of complex regulations.  Sometimes it seems that everyone has forgotten a crucial fact: the climate is changing much faster than these negotiations are moving. 

Meanwhile, out in the real world, climate impacts are all too visible. Since the negotations began 10 days ago, climate disasters have struck all over the world: flooding in Australia, Venezuela, the Balkans, Columbia, India; wildfires in Israel, Lebanon, Tibet; freak winter storms in Europe and the United States. These events have been devastating--hundreds are dead, and hundreds of thousands have been affected.

To put it in the context of our healthcare system, the unnecessary mortalities and morbidities are happening faster than our quality improvements are moving! In other words, if there are approximately 400,000 avoidable deaths annually attributable to healthcare encounters, this means that every day we delay implementing a viable solution we lose over 1,000 lives per day or about 45 lives every hour or 1 life every 1 and 1/2 minutes! In the time that it took me to write this post, 20 patients have lost their lives unnecessarily. Are any of them your loved ones?

All these lives come with stories, all these lives are loved by someone, and all these lives cannot just be written off as sacrificial lambs in the name of a growing bureaucracy that cannot move the meter. We can wring our collective hands and say that we wish we knew how to stop this gushing bleed. Yet, we continue to conduct business as usual, increasing revenues and testing and interventions and cognitive loads and questionable evidence. Ultimately, should eleven years of doing the same thing and getting the same woefully inadequate result encourage us to continue in the same direction, or should we just come to a full stop for a moment?

I realize that medicine cannot stop -- illness will not stop. But the lifestyle that feeds the gluttonous homicidal machine of healthcare can be altered. A combination of prevention, reduction of interventions of questionable effectiveness and safety, more time for doctors to think about their patients and make decisions together -- this is the path. It is not easy, but neither is losing a partner, a brother or a child to the very idol at whose altar we have come to worship and atone for all of our individual and societal bad choices. Today is the day. Who is with me?  

Healthcare quality: 5 ways to stop the insanity

It was Einstein, I think, who defined insanity as doing the same thing over and over again and expecting a different result. You could say that perhaps we are living this definition in the healthcare system today.

I talk a lot on this blog about quality and harms associated with healthcare. My take all along has been that we are continuing to miss the mark. I have known this because I follow and contribute to the emerging literature indicating that we continue to cause healthcare-associated infections and other complications at an alarming rate, even after the massive issue of avoidable hospital deaths was uncovered and popularized by the landmark Institute of Medicine 1999 report "To Err Is Human". And sure enough, over a decade after defining the problem, we now have not one but two studies coming our in tandem to indicate that we have not advanced an inch. At virtually the same time we are also learning that screening heavy smokers with CT scans can reduce lung cancer mortality by a whopping 20% (which in reality turns out to be only 0.3%, alas), with an accompanying risk of a false positive of 25%, as well as the fact that nearly 1/3 of all end-stage cancer patients die in our already overcrowded ICUs. Amid all of this bustle, there are breathless reports of eliminating nosocomial infections through simple checklists and hand washing, yet why are we not seeing any improvement in what really matters -- whether a patient who is meant to leave the hospital alive does in fact do so?

Well, to me this is what defines madness in our healthcare system. The news of the studies coming out of the Office of the Inspector General of the Department of Health and Human Services and from Harvard were not really new, as I have already indicated. More than any other specialty, the ICU community is well aware of the ongoing issues that arise from an onslaught of ever escalating numbers of patients with increasingly complex burdens of illnesses, a spiraling cognitive load of checklists and "evidence-based" quality indicators, and crushing documentation burdens in the face of overwhelming personnel short-falls and diminishing bedside time. Yet the Dartmouth researchers continue to show what they have been showing for decades: we are generously extending limited resources (both of interventions and human cognitive capital) to all who care to partake, without any limitation in the name of appropriateness or humanity. Death panels indeed! And, as the NLST underscores, we continue to look for salvation at the margins, where it is not only financially costly, but, because of the risk of adverse outcomes following invasive work-ups in patients with false positive CT findings, is likely to create an additional cadre of the chronically ill out of people who might not otherwise need to risk exposure to our already overwhelmed healthcare system.

At the same time, because patient turnover is what drives the bottom line, clinicians are compelled by the business of medicine to care for more and more patients. This discourages the time consumption of a thoughtful clinical encounter in favor of quick reactions usually involving multiple expensive tests, many of which may be avoidable with more time and attention to the specific patient at hand. Alas, clinicians who are willing to spend this kind of time do so at the peril to themselves, their families, and their sanity, putting themselves at a high risk for burnout, as their work days bleed into any semblance of personal time they might have hoped for. Because these are the very clinicians highly sought after by many in their communities, they end up giving up sleep in order to serve, and, well you know the story of how sleep deprivation affects judgment adversely, blah blah blah... And then they up and quit medicine.

Is this enough to diagnose insanity yet? Well, if not, then let's go to "evidence" in the relentless juggernaut of evidence-based practice guidelines and policies and reimbursement and quality metrics and and and... We have talked ad nauseam about evidence -- incomplete, invalid in some respects, non-individualizable. Yet, in the buzzing beehive of today's healthcare, it is this very evidence that must replace physician's thoughtfulness about any specific patient. Given its unavailability and inadequacy, coupled with the rush of a typical encounter, is it any wonder we are failing to fix our little quality quagmire? In fact are we not likely to make it even worse by continuing in this vein and rewarding behaviors that ostensibly impact the outcomes but in fact may represent nothing but noise?

So, here are my five potential solutions to the problem. They are not easy fixes, and they will not fit easily in a fortune inside a cookie or on a bumper sticker. All of them require broad educational efforts and social and scientific changes. Yet, we need to consider them seriously if we want to get back to first doing no harm:

1. Empower clinicians to provide only care that is likely to produce a benefit that outweighs risks, be they physical or emotional.
2. Reward the signal and not the noise. I wrote about this here and here.
3. Reward clinicians with more time rather than money. Although I am not aware of any data to back up this hypothesis, my intuition is that slowing down the appointment may result not only in reduction of harm by cutting out unnecessary interventions, but also in overall lowering of healthcare expenditures. It is also sure to improve the crumbling therapeutic relationship.
4. We need to re-engineer our research enterprise for the most important stakeholder in healthcare: the clinician-patient dyad. We need to make the data that are currently manufactured and consumed for large scale policy decisions more friendly at the individual level. And as a corollary, we need to re-think how we help information diffuse into practice and adopt some of the methods of the social sciences.
5. Let's get back to the tried and true methods of public health, where an ounce of prevention continues to be worth a pound of cure. Yes, let's strive for reducing cancer mortality, but let us invest appropriately in stuffing that tobacco horse back into its barn -- getting people to stop smoking will reduce lung cancer mortality by 85% rather than 0.3%, and at a much lower cost with no complications or false positives. Same goes for our national nutrition and physical activity struggles. Our social policies must support these well-recognized and efficient population interventions.

This may be the watershed moment to stop the treadmill of insanity that the business of medicine has created and continues to fuel. We must do better. And to do better, we must change course.           

Our nation's shocking Lady Macbeth moment

I am just cynical enough not to be easily shocked. This cynicism extends to our societal woes, and particularly our social and economic inequities driven by the worship of the free market theories. Yet, I truly was shocked by this article in Scientific American. And no, it was not the scientific confirmation of our intuition that poverty breeds stress, which in turn breeds difficult behaviors. What got me was this paragraph:

The United States currently leads the developed world with the highest maternal infanticide rate (an average of 8 deaths for every 100,000 live births, more than twice the rate of Canada). In a systematic analysis of maternal infanticide in the U.S., DeAnn Gauthier and colleagues at the University of Louisiana at Lafayette concluded that this dubious honor falls on us because “extreme poverty amid extreme wealth is conducive to stress-related violence.” Consequently, the highest levels of maternal infanticide were found, not in the poorest states, but in those with the greatest disparity between wealth and poverty (such as Colorado, Oklahoma, and New York with rates 3 to 5 times the national average). According to these researchers, inequality is literally killing our kids. [emphasis mine]

So, here we are, in the 21st century dystopia of escalating social inequities that are "literally killing our kids"! Yet, people who should know better, knowingly or unknowingly, continue to advocate the failed philosophy of objectivism, a system that advocates pursuit of rational self-interest, the supremacy of individual rights (selectively applied to the haves), and the cheer-leads for keeping government out of private market interactions (yeah, that worked really well with the banking industry).

But why let facts get in the way of our reality? Let me say it again: "inequality is killing our kids"! And it is doing it by relegating mothers to abuses of abject poverty, to be perpetuated by these holy "free" market forces (which incidentally are not free at all, but are sold to the highest bidder by the government, with each of us standing by eager to defend our own piece of the pie at all costs). This is not just deplorable, it is criminal. These maternal infanticide statistics, along with other less visible abuses concentrated in the socially expendable poor masses are on all our consciences. We may try to evade the crushing weight of this responsibility by robotically parroting free market mantra and personal responsibility lies. This will not change the fact of the blood on our hands.

The level of our healthcare debate is but a symptom of our willingness to walk away from this maternal holocaust. And no, this is not a socialist view, it is not a conspiratorialist view, and it is not anti-freedom view to acknowledge the moral bankruptcy of sweeping this problem, invisible to most of us privileged Americans, under the rug.

The realization is viscerally painful, yet the time has come. For those of us who need scientific evidence before we make any move to change our behaviors, there it is, for the taking. Science has spoken: "inequality is literally killing our kids". This is a call to social action. This is a call to save our future!

Quality improvements: Rewarding the signal and not the noise

In my post yesterday I questioned whether our current incentives are truly promoting quality or just prettier looking documentation. I used Dan Ariely's discussion on the fallacy of rewarding outcomes in the world of business as a jumping off point. But today it occurs to me that some of his suggestions about changing course to start moving in the direction of best achievable quality need to be further adapted to healthcare environment. So, I will try to do it here, and would love feedback, if you have any.

Here are Dan Ariely' recommendations on how to start rewarding the signal instead of noise:

1. Change the mind-set. Publicly recognize that rewarding outcomes is a bad idea, particularly for companies that deal in complex and unpredictable environments.

2. Document crucial assumptions. Analyze a manager’s assumptions at the time when the decision takes place. If they are valid but circumstances change, don’t punish her, but don’t reward her, either.

3. Create a standard for good decision making. Making sound assumptions and being explicit about them should be the basic condition for getting a reward. Good decisions are forward-looking, take available information into account, consider all available options, and do not create conflicts of interests.

4. Reward good decisions at the time they’re made. Reinforce smart habits by breaking the link between rewards and outcomes.

I think that I need to deconstruct some of them to make them applicable to healthcare. So, here are my healthcare equivalents of culture and incentive change, so that we can start focusing on better care.

1. Change the mind-set -- This applies to public reporting of never events. Tracking these on a large scale, say, city, state, country, is necessary so that we know how we are doing at not inflicting harm. However, at the level of an individual institution, there is so much variability in events such as infections, mortality, etc., that using them as a public humiliation tool is not sensible.

2. Document crucial assumptions -- We can adapt this to a healthcare setting to reflect how we build our systems to maximize prevention efforts. That is, in the setting of perpetually imperfect and oftentimes substandard evidence, in addition to tremendous inter- and intra-patient variability, a sensible evaluation of how best to approach each patient in the context of preventing complications is needed. If the evidence for interventions is valid, but the circumstances of how we understand the patient's condition change, we should not either reward or punish the provider or the institution for the associated outcome.

3. Create a standard for good decision making -- This is pretty easily adapted to our setting. Transparency, being up to date on the evidence, as well as the information on the particular patient, considering all that is reasonably available, and without conflicts of interest, are all part of the mandate for intentional quality improvement and individualized care. This also sets the criteria for what good decision support should look like.

4. Reward good decisions at the time they are made -- No translation necessary here, I think. The only thing I want to say is that there are ways other than financial to reward good performance, and we need to understand how they can be used to promote desirable behaviors among clinicians.

So, public lashings for having blood stream infections, ventilator-associated pneumonia and similar complications are not sensible. Relying on them simply reinforces the God complex in medicine and punishes the wrong link in the chain of events.

In general, it is time to let what we are learning in behavioral and cognitive sciences about what makes us tick help effect good behaviors at the bedside (and in the executive suite).          

When the fuel gauge is on empty: Gadgetry at the end of life

Today's post was going to be about false positives in screening trials, but this article in the NYT derailed me. So I will talk about false positives in a future post.

The NYT article talks in general about telemonitoring of elderly and chronically ill patients as it might impact both their health and the need for more acute and intensive encounter with the healthcare system. One specific case discussed is the Mayo randomized trial of home telemonitoring, complete with physiologic measurements and adaptive leading questions based on the derived data. If I understand correctly, the data are automatically conveyed to a nurse who can then contact the patient if something seems out of the ordinary. This sounds great, except for a few minor considerations.

One of these considerations, the fact that several recent studies have failed to show any differences in clinical outcomes of patients undergoing monitoring versus usual care, is well explored in the article. And of course, the newer and better studies use newer and better technologies that do not rely on patients to call in their results, and this is why we can expect better results from the Mayo study. Maybe. Or this could be a case of rescue and auxiliary hypothesis biases, no? I guess we will see.

But there is another elephant that stands in the corner without being discussed. This elephant is of course costs. Now, if I were designing the trial, I would also try to demonstrate that these monitoring devices and protocols will save healthcare dollars by reducing hospitalization rates and the need for other acute and costly interventions. Of course, in this case you have to ask "Compared to what?" Well, of course, this is compared to our usual care. And here is where I run into a problem, and in my mind this is the place where we should be intervening.

At the risk of sounding inhumane, I wish to point out several things. The patient discussed at the very beginning of the NYT story is 94 years old and has a chronic lung disease. Later on in the story, we learn that the average age of patients enrolled in the Mayo trial is 80; and we presume that they all have at least one chronic disease that requires monitoring. What am I driving at? No, it is not death panels, but it is a sensible approach to care at the end of life. Has anyone asked the 94 year old Ms. Hofstad with chronic lung disease whether she would prefer to see the healthcare dollars spent on prolonging her life or would she prefer that these dollars were used to provide Ms. Hofstad's daughter with prenatal care and her grandkids with vaccines? For this is the true trade-off: do we continue to invent ways to keep ourselves from facing our own mortality, or do we spend the limited yet wildly escalating healthcare dollars on sensible interventions that assure health for the next generation?

If any of this sounds unethical, I would submit that it is our current blinders-on discussion that is unethical. My guess is that the elderly who were manipulated by the "death panel" rhetoric are not aware of the very real choices having to be made between going on as we are, spending shocking amounts of money for infinitesimal gains at the close of life, being subjected to heroic interventions despite their futility, and allocating this money in favor of public health interventions that will ensure a huge incremental gain in our children's and grandchildren's future. These are personal questions, but when they are wrapped in political rhetoric, they lose their personal meaning. I can tell you unequivocally that, if it came to a choice for assuring ongoing life for me versus a healthy future for my children, even today, while I am still healthy and reasonably young, I would choose the latter. Is it conceivable that Ms. Hofstad and her peers would choose otherwise? I do not thinks so. So, we need to reposition our discussion of ethics of decisions at the end of life. The choices I gave as examples are real and need to be addressed explicitly, and we all need to be aware of these trade-offs in explicit terms.

I am not interested in terminating any life that is not ready to end. However, as I always say, the number one risk for death is being born -- we have not fooled nature or evolution yet to evade this outcome. Nor, in my opinion, should we try. We should all do our best to live a healthy and full life and learn to be comfortable with the idea of our own mortality. It is our evolutionary imperative to insure the durability of our species. Electronic monitoring at the end of life, although sexy and market-friendly, is not the way to set up the future generations for health and success. And it is certainly not a way to address our fear of death, the perennial third rail of our culture. It would be more ethical and responsible to start learning more about how to do this effectively than to continue developing new gadgets to keep the vessel moving even when the gauge is on empty.

I acknowledge that this is only one person's view, and the subject is complex and emotionally jarring. I am sure there are a lot of dissenting opinions on this subject, as there should be. We need a debate, where we name all of the factors and arrive at at a global solution that comports with our personal, societal and global interests. Let us start here and now.

CMS "never events": Are we rewarding the right thing?

A while ago I promised to write more about my thoughts inspired by Dan Ariely's Predictably Irrational. I still plan to do this, but in the meantime, this blog post by him made me think of medicine, and more specifically our incentives structure to prevent hospital-acquired complications (HACs). I am sure that by now everyone has heard of the "never events", so named because in the view of the Centers for Medicare and Medicaid Services (CMS) they should never happen. CMS is so convinced that they can be eradicated completely that they have eliminated payments for these complications in their effort to get hospitals to get serious about prevention. I do not have to tell you that hospitals these days are in dire financial straights, and every penny counts; so CMS is really getting them where it hurts. Here is the current list of never events, and it is likely to grow over time:

In fact, these very events are now being publicly reported as well, to help healthcare consumers navigate the quality labyrinth.

While waging an all out assault on these HACs is the absolute right thing to do, the question remains: Is it reasonable to expect zero rates of these complications? Well, for some definitely, while others I am not so sure. Take for example an object left inside the body during a surgery. Or how about amputation of the wrong limb? Or what about getting the wrong unit of blood intended for another patient? All of these examples are egregious consequences of human and systems error, and it is completely reasonable and even desirable to expect them never to happen. On the other hand, complications such as catheter-associated UTI or catheter-associated blood stream infection may not be as easily eliminated, and in fact may be impossible to eliminate completely. Why? Here is where Dan Ariely's analysis comes in.

He starts off by presenting a scenario of a soccer player kicking a ball with his eyes closed. It is clear that in the absence of intervening meddling from the wind or a playful dog (Fluffy, if you must know), the player can quickly perfect his aim despite not seeing the goal. However, it is these unpredictable events that interfere with the direction of the ball that are precisely the point, and can be applied to a business situation:

The problem is that there’s plenty of random noise in competitive strategic decisions. Predicting where the ball will go is equivalent to deciding whether to open a chain of seafood restaurants on the Gulf Coast. The dog running off with the ball is the BP oil spill. When the board reviews the manager’s performance, they’ll focus on the failed restaurants. The stock is down. The chain lost money. Since the manager’s compensation is tied to results, he’ll incur financial penalties. To save face and appear to be taking action, the board may even fire him—thus giving up on someone who may be a good manager but had bad luck.

So, in business what is rewarded or punished is not a systematic approach to decision making, but that random noise responsible for either getting the ball into the goal or alternatively diverting its trajectory. And this of course says nothing about either the soccer player or the business manager.

This situation is certainly analogous to the incentive structure for never events, where the hospital becomes the soccer player with its eyes closed aiming for the goal, but gets derailed by Fluffy, in this case in the persona of the patient's susceptibility to infection, say, and gets dinged for something that is completely random and not in the control of the clinician. In fact, Ariely unequivocally states something rather startling:

The oil spill example is an extreme case. In the real world, the random noise is often more subtle and various—a hundred little things rather than one big thing. But the effect is the same. Rewarding and penalizing leaders based on outcomes overestimates how much variance people actually control. (This works both ways: Just as good managers can suffer from bad outcomes not of their own making, bad managers can be rewarded for good outcomes that occur in spite of their ineptitude.) In fact, the more unpredictable an environment becomes, the more an outcomes-based approach ends up rewarding or penalizing noise. [emphasis mine]

Unpredictable you say? What can be more unpredictable and filled with uncertainty than the interaction of human biology with disease and external interventions? This repositioning of the argument really confirms for me that demanding never events is really just window dressing. For a long time there has been a joke among health services researchers that, over the next few years, these events will disappear, but not because these events actually disappear. Sophisticated hospital coders will simply stop putting these outcomes in their documentation to the payers. And will this achieve better care or just better looking documentation? I think you know what I am driving at.

What is the answer? Well, here is what Ariely suggests:

We can’t entirely avoid outcome-based decisions. Still, we can reduce our reliance on stochastic outcomes. Here are four ways companies can create more-sound reward systems.

1. Change the mind-set. Publicly recognize that rewarding outcomes is a bad idea, particularly for companies that deal in complex and unpredictable environments.

2. Document crucial assumptions. Analyze a manager’s assumptions at the time when the decision takes place. If they are valid but circumstances change, don’t punish her, but don’t reward her, either.

3. Create a standard for good decision making. Making sound assumptions and being explicit about them should be the basic condition for getting a reward. Good decisions are forward-looking, take available information into account, consider all available options, and do not create conflicts of interests.

4. Reward good decisions at the time they’re made. Reinforce smart habits by breaking the link between rewards and outcomes.

And even though this advice is aimed at business leaders, it can be easily adapted to medicine. If we heed this warning, we may avoid having to wring our hands in another 10 years about the "unintended consequence" of losing critical data needed to understand how we are really doing with improving healthcare outcomes.

I will end with Ariely's own words, since I can do no better to summarize (you can substitute appropriate healthcare related terms for the business ones):

Our focus on outcomes is understandable. When a company loses money, people demand that heads roll, even if the changes are more about assuaging shareholders than sound management. Moreover, measuring outcomes is relatively easy to do; decision-making–based reward systems will be more complex. But as I’ve said before, “It’s hard” is a terrible reason not to do something. Especially when that something can help reward and retain the people best able to help you grow your business.