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Sunday, May 27, 2012

Policing our own

The Secret Service is in the news. I am be fairly certain that the leadership of the Secret Service basically never wants its agency to be front and center in the news. It is hard to keep it "secret" when what it is up to is not so secret.

The gist of the story is that agents in Columbia, who were acting as an advance team for President Obama, were caught with prostitutes in their hotel rooms. This was not the product of a specific sting effort but actually was the consequence of one particular agent trying to stiff (no pun intended) a prostitute who had spent the night with him. She was not awed by the vaunted Secret Service and went through her usual channels to expose a customer who failed to live up to their end of the bargain. Thus, this particular episode ended up with a Congressional hearing. Who would have figured.

As a consequence of all this, all sorts of interesting tidbits of information have become public, relating to less than desirable behaviors of Secret Service agents through the ages. The famous stories about the Secret Service leading up to the assassination of President Kennedy have been rehashed. On top of this, numerous other anecdotes regarding isolated misbehaviors of  agents have been described. We have no idea of how prevalent these behaviors are but two things are obvious. First, the Secret Service is made up of young people, primarily young men and these people, particularly young men, have urges..frequent ones. Second, if the local culture does not provide them with prompt feedback not to succumb to urges, they will succumb to those urges. The most important part of the local culture are their immediate peers and local supervisors. In the case of the Secret Service, this local culture was not inclined to act when they observed their peers engaging in activity which we could characterize as not desirable.

I read Maureen Dowd's piece in the New York Times this morning and perhaps the most intriguing port were the comments. What I took away from the comments was that the specific behaviors which the agents engaged in are view is many different lights by the public at large. I suspect that there is also a similar spectrum of belief held by  their fellow agents. From the perspective of the Secret Service, there is no question that hiring prostitutes, while technically not illegal in Columbia, places the agency and their charges at some additional risk and is therefore unwise. However, the magnitude of the risk is undefined and from the perspective of the agents involved, it may appear to be very small since it is highly likely that they have been watching behaviors like this for years and nothing has happened.  They likely view this in the same light we view coming to a rolling stop at a stop sign or having a few glasses of wine with dinner and driving home. Probably not the smartest thing to do but everyone does it.

While the Secret Service story holds the public because of the obvious titillation factor; sex, powerful men and wasteful and inept government, there is a broader message here. Congress is now up in arms because the Secret Service appears to be incapable of policing itself. This is not surprising but what should also not be surprising is that the inability to self police is not unique to the Secret Service. Look elsewhere and what you will see is the same phenomena, in financial markets, in education, in biomedical research, in health care, the Catholic Church, and the Penn State athletic programs to name but a few in the news recently.

What all of these have in common is that these entities are made of communities of people who have a wide range of views as to acceptable and not acceptable behaviors. Furthermore, most people are inclined to leave other people alone and not challenging their peers, short of the most egregious activities. I can attest to situations within health care and biomedical research where I have observed varying degrees of  compulsiveness in adhering to particular norms.

In the health care practice realm, we are constantly faced with scenarios where we are in a position to second guess someone else's judgment, almost always without a complete story. When does a particular behavior reach the threshold for a response? Was that informed consent really adequate? Was that really the indicated procedure? Did that patient warrant treatment with that drug and were they really aware of the risks involved?  The default mode is to take care of what you can take care of and ignore the rest. Periodically we face situations where particularly egregious examples of behavior hit the press where physicians have been committing outlandish acts and it appears that no one appears to care or they may even be viewed in very positive lights until the OIG or other oversight body brings the hammer down.

In the case of biomedical research, the recent observations that much published high impact basic and clinical trials cannot be repeated would imply that a similar dynamic exists in this realm. We have peer review but the recent revelations point to limits of the peer review system in dealing with issues like these. Within our own research programs we grapple with the tension between publishing good vs. perfect data. Waiting for perfect results means that you will never publish anything. However, within the scientific community there exists a range of standards for what constitutes good enough and a potential for a funding advantage to redefine that good enough standard to a more minimal threshold. Does something constitute sloppiness if actual dishonesty? Where does that stop and how do we police this?

I have no pat answers. Self policing has its real limits. These types of quandaries are reflective of a broader range of behaviors both within and outside of medicine and research which can best be characterized as gaming behaviors. Wherever we find ourselves, we find that there are people who are very comfortable pushing to find where the boundaries are for acceptable behavior and actions. All of us are likely to be called upon the judge and blow the whistle on others are likely guilty of at least some gaming behavior and likely worse. We will be hesitant to hold their peers accountable when  we are aware of their own actions which fall short of perfection.  We remember when we looked for that particular angle to maximize our own gains.

However, before we call for creating  of in increasingly complex regulatory environment, we need to recall that this does not appear to work so well either. Those regulated and those who do the regulation often become partners in what has been termed regulatory capture.  Human nature being what it is means that we are not to be trusted and not amount of third party oversight can domesticate the risks of dealing with people. The world works on trust but the truth is no one or things made up of people can be completely trusted. Good institutions are compatible with bad outcomes and our quest to perfect them and perfect people may result in unintended and less desirable results.

Saturday, May 26, 2012

Unintended consequences of not profit seeking in medicine - The Fable of the Bees all over again

Paul Rubin wrote a nice piece in the WSJ Op-Ed section last Thursday. In it, he addresses the bias against profit seeking behavior and the lack of understanding this appears to indicate (
We economists assume that firms always maximize profits, and that profit maximization by firms (all firms, not just private-equity ones) is a very good thing. But this is not because profits are in themselves good. Rather, profit maximization is good because it leads directly to maximum benefits for consumers. Profits provide the incentive for firms to do what consumers want.
Consider what contributes to profit maximization. In simple terms, profit maximization means producing the products earning the highest returns, and producing these products at the lowest possible cost. Both are socially useful behaviors that benefit consumers.
Which products produce the highest returns? The answer is the products that consumers want and are currently underproduced. If there are excess returns (profits) to be earned in some market, that is because consumers are willing to pay more for those products than the current cost of production.
Profits are earned by producing more of these products—that is, by satisfying unmet consumer demands. 
The last line is is the punch line. Ideal economic systems reward those who meet unmet demands. While Dr. Rubin's purpose was to link these concepts back to Bain Capital and the presidential election debates, I could not help but reflect upon how the profit motive is viewed by leadership in health care. It is viewed in an extremely negative light. Legitimate health care entities are not for-profit entities and for profit health care entities who strive to maximize shareholder returns lack legitimacy. They are only in it for the profits they can earn.  

At a superficial level, this might feel right. Medicine should be a calling and the motivation which drives those of us who devote our lives to delivering care to the sick should not be in it for the money. However, Professor Rubin's words highlight what may be counter intuitive; that striving for individual gain may be the best way to accomplish the most good for the greatest number. Bernard Mandeville in his 18th Century work "The Fable of the Bees; Private Vices, Public benefits first attempted to popularize this concept (not very successfully) while this was ultimately built upon by Adam Smith. This concept has been controversial and not widely accepted.

Obviously one of the realms it has not been accepted is within health care leadership. What is the problem with taking the profit motive out of what now is approaching 20% of the US economy? The problem is the loss of the unintended consequences of the search for private gain. No where is the misalignment of  what the public wants and what an industry strives to deliver more evident than in health care. What other industry creates large marketing budgets to sell services with a paucity of buyers when simultaneously there is huge unmet demand  for services the public is clamoring for?

If the profit motive within a market system existed within medicine, there would be a rapid re-deployment of resources where there was limited demand and these resources would be deployed to where maximum profit could be made by offering services which the public clamored for at prices which attracted new entrees into the market. Those interested in maximizing profits would be also be incentivized to cut prices and costs to maximize their own returns while be able to deliver services to the public at lower costs as well. Too many expensive scanners and not enough primary care physicians, let the power of supply, demand, and price find a better equilibrium.

That basically does not exist in health care. Floors to prices are set by Medicare. Only a fool would charge less than Medicare will pay. Profit seeking happens but via mechanisms divorced from responding to consumers, unless one views health insurers as the customers, which may hold more than a shred of the truth. It has been said that if you are not paying for the service, you are not he customer but are the product.  That is where many patients now stand.

If we want to create a better health care system, we need to re-infuse the profit motive back in with the idea being we will be rewarded for providing better service to patients at lower cost. Without recognizing the role of profits in moving toward this end, the outcomes will almost certainly be less optimal than if we recognized the basic concepts which Paul Rubin reminded us of.  

Sunday, May 20, 2012

The impact will be faster than we think

Google's driverless cars -

I found it interesting that there are no laws regulating this...yet. While pricey now, the cost will plummet. First, no one will know how to drive a manual transmission. Quickly thereafter, no one will know how to drive!

Unintended consequences

The Chicago Tribune has released a multi-part series on the history of deployment of flame retardant materials in household furniture.  (  It is quite the eye-opener. I am not at all certain about the actual risks of the materials but the history of how these materials got incorporated into our household things and ultimately into ourselves provides lessons into a spectrum of interventions which may lead to unintended consequences.

The idea was quite simple. Make furniture less flammable and prevent household fires which start when furniture is ignited, particularly by an unattended cigarette. What harm could come from this? The problem with this model is that in order to avoid the bad outcome to a small number of people, you need to deploy an intervention that touches millions who would have never been affected. Furthermore, when you start to deal with millions of people, you can never anticipate the nature of the impact you will have. Even impacts on a small percentage of a large number of people can be a large number. Remember Janet Napolitano and her confusion of a small percentage of people screened by the TSA equating to a small number of people.

Now years later, we have entire entire public awash in flame retardants, turning up in breast milk. At best, this is a public relations nightmare. At worst, we have a public health nightmare. We simply do not know. It would have been great if the materials deployed actually had a demonstrable positive impact on public health. That appears to be at best contestable. From the Tribune article:
Many couches, love seats and chairs sold nationwide contain flame retardants to comply with a California flammability rule. But studies by the U.S. Consumer Product Safety Commission have concluded that this standard provides no meaningful protection from deadly fires.

The standard requires that raw foam withstand a candle-like flame for 12 seconds. But, Babrauskas said, upholstered furniture is covered with fabric, and if the cover ignites, the flames from the fabric quickly grow larger than that of a candle and overwhelm even flame retardant foam.

"The fire just laughs at it," Babrauskas said.

The bottom line: Household furniture often contains enough chemicals to pose health threats but not enough to stem fires — "the worst of both possible worlds," he said.

What I like about this story is it embodies so many elements of unintended consequences. The angle of the flame retardant companies was they were the champions of protecting people, especially children from being injured by burns. In order to do so, the approach taken was to expose countless millions of people to flame retardant chemicals, thus posing a different set of risks to the public, including children. Much of this played out the political realm in a relatively but not entirely data free world. There is some data supporting incorporating of flame retardants into sleep wear ( As controversy began to rage and the EPA found itself in the middle, what is an agency to do. It was being forced to choose between taking a position against "life saving" chemicals which prevented baby flambe' and the exposure of millions of people to undefined risks associated with those same "life saving" chemicals.
In a statement, the EPA said it is largely powerless to do anything about chlorinated tris. The agency cited industry's continued use of the chemical as a stark example of why it supports "much needed reform" of the nation's chemical safety law.

Jerome Paulson, a George Washington University pediatrician who last year wrote a stinging critique of the law for the American Academy of Pediatrics, said the system especially fails to protect children. The group wants safety standards for industrial chemicals to be more like those governing pharmaceuticals and pesticides, with chemicals being approved only if a "reasonable certainty of no harm" can be verified.
The system fails children? Children were a major reason these chemicals were added to fabrics and furniture in the first place! I could not find specifics but I strongly suspect the same organization warning us about flame retardants was likely at the forefront pushing for flame resistant clothing. Furthermore, other "experts in the burn world were issuing cautions against any relaxation of regulations requiring incorporation of flame retardants into infant sleepwear. From Pubmed...
J Burn Care Rehabil. 1997 Sep-Oct;18(5):469-76.

Children's sleepwear: relaxation of the Consumer Product Safety Commission's flammability standards.


Via Christi Regional Medical Center, Wichita, Kansas, USA.

Erratum in

  • J Burn Care Rehabil 1998 May-Jun;19(3):267.


The Consumer Product Safety Commission voted on April 30, 1996, to relax the existing children's sleepwear flammability standard under the Flammable Fabrics Act. The new amendments will permit the sale of tight-fitting children's sleepwear and sleepwear for infants aged 9 months or younger-even if the garments do not meet the flammability standards ordinarily applicable to such sleepwear. The relaxed standards became effective January 1, 1997. These changes have the potential to increase the number of childhood injuries and deaths resulting from burns associated with children's sleepwear. Burn care practitioners and fire prevention educators must understand the significance of these changes and their associated impact. It is essential that this information be disseminated throughout communities to make the public aware of the potential hazards emanating from these changes. Furthermore, organized and systematic data gathering and appropriate pressure should be exerted on the Commissioners of the Consumer Product Safety Commission to force a reversal of the newly amended regulations.

Then there is California Technical Bulletin 117. This is described in a Scientific American article "Foam Alone" from (
At issue is something called Technical Bulletin 117 (or TB 117), an obscure California law enacted in the late 1970s. It requires all furniture stuffing foam in the state to withstand 12 full seconds of open flame, analogous to a cigarette lighter held against a couch with the upholstery ripped off. Furniture flammability is largely regulated by states, and California is by far the toughest. 
While there is no Federal law requiring the addition of flame retardants to furniture foam, this California rule essentially forces all furniture manufacturers to comply with this rule because of fear of being sued. Thus, an  ill conceived rule on one state has unintended consequences in the remaining 49 states.  We are awash in flame retardants to protect us against something, the frequency of which we did not know when we implemented the requirements.

Perhaps the most striking unintended consequences in all of this are those initiated by and those impacted on Dr. David Heimbach.  Dr. David Heimbach has devoted his medical career to improving the care of burn victims. He has over 160 peer reviewed publications and was the Tanner-Vandeput-Boswick Burn Prize winner in 2010. I do not know him but his accomplishments and life's work appear to be something to admire. However, he screwed up. In reviewing his bibliography, I could find nothing in his corpus of scholarly work which would qualify him as an expert in fire retardants. He apparently was effective as an advocate because he could tell stories. He might have been perceived as an expert and he might have even viewed himself as an expert as well. I hope he can come up with the data which can support the positions that he advocated for. I hope this does not serve as the defining issue of his career. They have already scrubbed the University of Washington site of his bio.

The story  has lessons for the medical community. When you take a stand, think hard about whether the stand you take is data driven and you can represent yourself as an expert or whether you can tell only stories and you are just one of many advocates pushing for something that your feel is the right thing to do. You might be believed and your agenda might have unintended consequences, for yourself as well as others.

Saturday, May 19, 2012

Timing is everything

I am involved in planning for major transitions in health care, working for a major health care system in the southeast. Everyone knows that something is coming. We have a basic idea of the nature of the transitions; moving from being paid "per click" to receiving bundled payments of some sort for the care delivered to populations of people. I work with very smart people with the right intentions and motivations. No matter how smart we are, we are only guessing as to exactly how this will all play out.

I think there are a few guiding principles which we need to stick to. First,  timing will be essential. This will not a work where the earliest adopters will be rewarded. I am reminded of an experience I had when growing up in upstate New York. We would regularly drive to visit my grandmother in Brooklyn, piling into the car late Friday afternoon for the 8+ hour drive on the NY Thruway. My father would stoically drive and we would arrive exhausted after midnight with cranky children. To add insult to injury, he would then need to get up early the next morning to move the car to the other side of the street since the alternate side parking rules were in effect.

Now if the challenge were that he simply had to drag himself out of bed, that would be one challenge. However, when moving the car, timing was important. Get up to move the car at 6 am when the change was required meant that all the good spots were already taken. Move too early and you could get ticketed for parking illegally. Early and late responders were both punished. People would sit in their cars waiting for the right time to make their move.

This is similar to what we face in the health care arena. Activities which generate large margins now run the risk of being cost centers some undefined time in the future. Moving from the "per click" world to the bundled payment world is analogous to moving from one side of the street to the other.  In the health care realm, we are pretty sure something will happen but we are not quire sure of what it will be and when it will happen.  At least my father knew that the parking switch had to happen and there was a fairly specific timetable (plus or minus a few key minutes).

We end up making all sorts of plans and hedges. When we are paid via bundled payments, we will want to care for patients in the lowest cost realm we can identify, without compromising care. Does that mean we should keep patients out of the hospital now even if hospitalizations are the engine which finances the system now? This highlights the second major principle. Systems which will survive will be ones that are nimble and can change course quickly. No matter how good your planning might be, most of the plan will be off base because the future is not knowable. The key to survival will be knowing the present and being able to define how the present present is different from the recently passed present in real time.

We will need to know what it costs to deliver specific elements of care and what value these elements actually deliver to patients. In a world where our payments are bundled and we care for populations for flat fees, delivery of expensive care which provides no value to patients is the fast track to extinction. Presently we are rewarded for doing high end things which enrich health systems and providers and may of may not do much for patients. When the switch happens, we are not going to be so inclined to continue expensive approaches when the expense is our own.

The distinction between being efficient and stinting on care is a nuanced one. Withholding something that provides patients value is stinting.  Failure to deliver what patients do not need is efficiency.  To make this distinction, you need to be able to measure the value delivered. We are not so good at this yet but we better get good at this soon. Our ability to define what we should provide and what we can afford to provide in a world of bundled payments is is the difference between enduring institutions and oblivion.