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Sunday, December 7, 2014

Intentions are only part of the picture

I am no great fan of empowering the police to intervene in our citizens lives. I look at the current wave of outrage regarding police killing with a great deal of ambivalence. The deaths are a culmination of a host of circumstances and addressing police over reach will not be fixed easily. Drawing attention to these killings using protests is a step toward holding those responsible accountable. However, I believe it is reasonable to consider taking a broader view of who is accountable.

We need to remember who the police are and why they are employed. They are agents of the state and employed to enforce the law. The more laws and rules we have, the more we will need to employ police to enforce them. The more we desire to the state to micromanage the affairs of its citizens, the more intrusive the it becomes, through the actions of its enforcement agents which include the police.

At the most simple level, we need to understand that not all undesirable behaviors should be prohibited using the power of the law. However, that concept seems to be ignored as we increasingly embrace the view that many if not all undesirable actions should be curbed primarily via the use of state force.

Attempts to curb the use of alcohol resulted in an unmitigated failure which are understood under the term Prohibition. Prohibition (capital P) resulted in expansion of state powers, corruption of law enforcement, and creation of powerful crime syndicates. While prohibition of alcohol has all but ended, we have not abandoned a variety of other prohibitions (small P) including various drug prohibitions. They have has the same effects as alcohol prohibition and have been equally unsuccessful and perhaps even more destructive in terms of unintended consequences.

Prohibitions in general have resulted in resulted in expansion of police powers (all in the name of the war on drugs) and have served as the basis for civil seizure statues (blogged on earlier). The death of Eric Garner would not have happened if not for the state of NY heavily taxing cigarettes and creating incentives for creation of an underground economy.  Professor Stephen Carter is cited by Ilya Somin (Professor of Law at George Mason University) in the Washington Post (Link):
On the opening day of law school, I always counsel my first-year students never to support a law they are not willing to kill to enforce. Usually they greet this advice with something between skepticism and puzzlement, until I remind them that the police go armed to enforce the will of the state, and if you resist, they might kill you.
I wish this caution were only theoretical. It isn’t. Whatever your view on the refusal of a New York City grand jury to indict the police officer whose chokehold apparently led to the death of Eric Garner, it’s useful to remember the crime that Garner is alleged to have committed: He was selling individual cigarettes, or loosies, in violation of New York law…..

The problem is actually broader. It’s not just cigarette tax laws that can lead to the death of those the police seek to arrest. It’s every law. Libertarians argue that we have far too many laws, and the Garner case offers evidence that they’re right. I often tell my students that there will never be a perfect technology of law enforcement, and therefore it is unavoidable that there will be situations where police err on the side of too much violence rather than too little. Better training won’t lead to perfection. But fewer laws would mean fewer opportunities for official violence to get out of hand.It’s not just cigarette tax laws that can lead to the death of those the police seek to arrest. It’s every law. Libertarians argue that we have far too many laws, and the Garner case offers evidence that they’re right.

As Carter notes, “activists on the right and the left tend to believe that all of their causes are of great importance. Whatever they want to ban or require, they seem unalterably persuaded that the use of state power is appropriate.” But we should always remember that “[e]very new law requires enforcement; every act of enforcement includes the possibility of violence.” If we really want to curb police abuses, we should think carefully about whether all the laws we have on the books are really worth killing for.

All powerful tools have the potential to do great good or great harm.  

Politics, transparency, and appealing to our emotional brains

"It is hard to reason someone out of belief they did not reason into".  I am not sure where I heard this quote. I know it was not mine but I do not who to credit it to. However, it really summarizes what I observed in the last political season.

When the campaigns began, candidates for the most part tried to take the high road, appealing to the voters on the basis of intellect and reason. I came to realize that these appeals were directed to what Kahneman and Tversky called system two, our cognitive brains. However, as the campaigns progressed and became more competitive, the focus of ads changed. The term often used by the commentators was "going negative". I realized that going negative simply meant changing from focusing on the cognitive brains of voters to their emotional brains or what Kahneman and Tversky called system one.

It only makes sense to do this given the role that our emotional brains play in decision making. Politics will always ultimately be decided by emotion. We are emotional creatures. Move something into the political realm and this is what you should expect. Don't be surprised when this happens.

Recognizing that voters respond at an emotional level to issues they may not fully comprehend on a cognitive level may be interpreted as believing that voters are stupid. The world is so complex and the amount of information out there to assimilate to understand the huge universe of issues is beyond the comprehension of any given human. When we run into situations where we do not have all the information to make deliberative decisions, we default to using our emotional brains.

The arrogant pricks out there use these circumstances to call the public stupid. I use these circumstances to highlight why certain decisions should not be moved into political spheres.

Truth and Error - Tragedy in Charlottesville

I am reading a book by Kathyrn Schulz entitled "Being wrong: adventures in the margin of error". The chapter I am reading now is Chapter 4: Our minds, part one: Knowing, not knowing, and making it up. At the same time I have been listening to and reading about the accounts from the campus of the University of Virginia that first appeared in Rolling Stone magazine. I have realized that what is in Schulz's book is relevant to the events in Charlottesville.

Everyone who has read the accounts was mortified by just how awful the events described were. I have to admit that when my wife first told me about this and read me excerpts, I was very disturbed but there were elements to this story which began to remind me of the fantastic accounts of preschool molestations (nicely summarized in Wikopedia When the preschool molestation cases broke, which were high profile stories for more than a decade and resulted in likely innocent people spending substantial time in jail, I had a difficult time how people could report such stories, which were ultimately found to be false.

The UVA rape story now also appears to be coming unravelled. The account provided by "Jackie" turns out to be riddled with inconsistencies, so many that it is hard to fathom how a magazine such as Rolling Stone could have released such a story, without what appears to be very basic due diligence.

An explanation for these events may reside in our brains and how we remember. Our brains are much less than perfect in terms what and how we remember things. For example, in her book Schulz describes a woman who was literally blind to her own blindness. When asked to described an object placed in front of her, she would described it in detail. The problem was she was blind, literally. Despite this reality she created a detailed description of what she thought she saw and fully believed that object was there. She was blind to her own blindness. While these examples represented an extreme case of blindness to error and current state, we all seem to exhibit blindness to our own realities and errors. As Schulz notes:
In sum: we love to know things, but ultimately we can't know for sure that we know them; we are bad at recognizing when we don't know something; and we are very, very good at making stuff up.
Which now brings me back to the controversies in Charlottesville. It seems that what people recall, particularly the details of especially traumatic events in their lives, is almost always wrong when examined later in their lives. Schulz tells the story of Ulric Neisser, who vividly remembered the day the Japanese bombed Pear Harbor (oddly enough 73 years ago today). The narrative he carried with him was that of a radio announcer interrupting a professional baseball game, telling the story of the surprise attack. Only later did he realize that the details of the story he carried with him were wrong.  Professional baseball is not played in December.

Neisser went on to become a psychology professor and study memory failure, calling into question dogma about the veracity of recalled memories. As it turns out, our recollections of events such as the Kennedy assassination, the Challenger disaster, and the Twin Towers disaster may seem vivid but are almost always wrong, despite feeling so right. The numbers are pretty staggering. Neisser studied the Challenger disaster, asking students details the day after it happened and then three years later. Less than 7% of the second reports matched the initial reports. 50% were wrong in 2/3 of their assertions and 25% were wrong in every major detail.

How does this relate to what has happened in Charlottesville? The story broke two years after the events happened, although even the timeline must be called into question. When something happened is simply another detail which may or may not be recalled correctly. How does one call into question the recollections of someone who suffered a traumatic event without accusing this individual of lying or making things up? It seems that the norm is to recall things with many errors and it should not come as a surprise that her account has serious inconsistencies. All accounts of events in the past will have errors and we will be blind to them.

Truth can only be verified by some sort of recording which is done at the time of the event which ideally can be done independent of human filtering. That is a reality we have to live with. We will be frequently wrong but unfortunately often not in doubt, even when we might be completely wrong.

Saturday, October 11, 2014

Civil Asset Forfeiture

I was trolling my usual set of blogs and came across this video of John Oliver (John Oliver). It is truly frightening. I am not sure how we have gotten to the current state, but it seems that we have empowered various law enforcement entities to take our property without cause. The stories he tells, which are similarly recounted in recent stories written in the New Yorker and the Washington Post (washingtonpost asset forfeiture), are strangely reminiscent of tales of local speed traps, only much worse.

As noted in the New Yorker article published by Sarah Stillman a little more than one year ago (Taken), what we are seeing now is due to the unintended consequences of laws passed in the 1970's.
"Forfeiture in its modern form began with federal statutes enacted in the nineteen-seventies and aimed not at waitresses and janitors but at organized-crime bosses and drug lords. Law-enforcement officers were empowered to seize money and goods tied to the production of illegal drugs. Later amendments allowed the seizure of anything thought to have been purchased with tainted funds, whether or not it was connected to the commission of a crime. Even then, forfeiture remained an infrequent resort until 1984, when Congress passed the Comprehensive Crime Control Act. It established a special fund that turned over proceeds from forfeitures to the law-enforcement agencies responsible for them. Local police who provided federal assistance were rewarded with a large percentage of the proceeds, through a program called Equitable Sharing. Soon states were crafting their own forfeiture laws.
Revenue gains were staggering. At the Justice Department, proceeds from forfeiture soared from twenty-seven million dollars in 1985 to five hundred and fifty-six million in 1993. (Last year, the department took in nearly $4.2 billion in forfeitures, a record.)..."

 The power to take down the likes of Pablo Escobar has been transformed into the power to terrorize innocent people. Numerous examples of local police using routine traffic stops to  seize (steal) cash from people who have committed no crime, only the indiscretion of carrying cash or other valuables in their cars. The seizures did put a dent in the activities of criminals. However, they also provided a tool for law enforcement to steal of the innocent public without due process or recourse.

Sunday, September 21, 2014

Lack of price transparency and the normalization of deviance

I am confident that the story is not going away. Again on the front page of the Sunday Times today is yet another story about the lack of transparency in health care billing which is accompanied by a litany of comments from people who reinforce the message. (NYT- Billing surprises)

The story itself is about a young man who had the acute onset of a neck injury; a herniated set of disks which resulted in pain and neurological dysfunction. He thought he had his ducks lined up and had properly researched his options and the costs. However, he was blindsided by a bill from an assistant surgeon who he did not recall actually meeting. The bill for the assistant surgeon...$117K. What did this surgeon do to justify such a fee? That was not so clear and oddly enough the payment to his primary surgeon ended up being less than 1/10th of this amount.

The stories from those who wrote in that followed the Times story showed a consistent theme. Providers who swooped in during a medical stay, delivered some sort of perfunctory service (or not?), and dropped some sort of outrageous a bill. How common is this? Who knows but perhaps this is not such a rare event.

In my opinion, this phenomena can be traced back to two fundamental issues. The first issue is the widespread and apparently expanding gaming of the billing system. There is no question that the current system has opportunities for exploitation. In the earlier part of my career, the relative lack of financial pressures and the anchor of professionalism served as a brake on such activities. As individual actors identified and leveraged opportunities and their financial windfalls became more apparent to the broader medical communities, the brake exerted by professionalism weakened and the outrage previously expressed over outrageous billing practices disappeared. Why be a chump and "leave money on the table?"

We rationalize such beliefs by looking at all the activities we engage in which provide no or insufficient financial compensation and do some balancing math. However, once you have made that transition and are comfortable with accepting payment not commensurate with activity and value you  added, it becomes a slippery slope. There may be no upper limit on what some will ask for, especially when third parties pay the fee and insulate the patient from the bill.

However, the other issue is no one is really in charge. Patients are cared for a "team" of people who operate in different silos and who are not coordinated in their efforts. There is no big picture person who has the incentives to make team roles explicit. One might think that the lead surgeon would be this person but that is generally not the case. Review a chart of a patient hospitalized for a particular intervention and look for specific orders regarding consultations. You are not likely to find them and if you do you are not likely to find anything specific of what the actual deliverables might be. There we have it; no defined team, no defined roles,  no one in charge, and little or no accountability.

Creations of well functioning teams would go a long way to solve this problem. A team leader should be accountable in terms of everything that happened before, during, and after surgery. Before this person would make sure that the patient was aware of  who was on the team, what their roles would be, and what the costs should be. However, this would require a change is how we are paid since at this point in time, there is no financial value associated with this type of activity, even though there might be tremendous value brought to the patients involved.

I believe we either fix this issue or we undermine the trust of patients to a point where it becomes irreparable.

Sunday, August 24, 2014

Continued disruptions in health care

The New York times published a piece this morning titled " Blood Industry Shrinks as Transfusions Decline". The story contains multiple elements reflective of the changes and disruptions affecting the health care industry.

What is more fundamental in medicine than blood transfusions? There is some controversy regarding the first transfusion. It has been reported that Pope Innocent VIII received the blood of three ten year old boys in 1492 although it is not clear when the blood was infused or ingested. Jean Denis transfused lamb blood into a young woman in 1667, a procedure complicated by a hemolytic reaction which fortunately for the patient, she survived. Unfortunately for Denis, reactions in subsequent reactions were not so benign, resulting in madness and death. The practice was dropped and not undertaken at all for the next 150 years.

In the 19th century, various attempts to revive the practice lead to variable successes. However, it was not until Karl Landsteiner began to define human blood groups in 1900 that more widespread deployment of human to human transfusions could be undertaken. Blood group characterization was then refined over the next 100 years. In addition, a host of other technological breakthroughs including anti-coagulants, preservatives, refrigeration, sterile (or clean)  technique, material science (plastics), and screening for infectious diseases made the practice safer and more effective. It was during war that the much of the practical improvements were driven with life saving impacts.

As noted in the NYT piece, blood banking and the American Red Cross moved to an industrial scale after WWII, about 70 years ago. However, the heyday of transfusion medicine may be behind us. The demands for transfusions are down a almost by a stunning one third in the past five years. This appears to be due to multiple factors including the use of minimally invasive surgery, substitute products, and changing indications for use of transfusions.

Regarding the last factor, decision support tools linked to electronic health records may be having a profound effect. While changing recommendations regarding medical indications may have limited effects if deployments are dependent upon individual physicians embracing the changing recommendations, the same recommendations tend to be adopted more readily if reminders and prompts are embedded in computerized physician order entry systems (CPOE). Orders entered which are at odds with guidelines require some sort of physician action to override the defaults which are also tracked. This has changed the use of transfusions and discouraged what is now viewed as inappropriate use.

The drop in use has prompted a host of consolidations and cost savings activities. The industry is shrinking in terms of employment footprint. As noted in the Times article (emphasis mine):
The change has come as a shock to workers. Marjorie Krueger, the administrative director of the Communications Workers of America for the area including Virginia, West Virginia, Maryland, Pennsylvania and Delaware, said that when the Red Cross began laying off union-represented workers in 2010, “We honestly didn’t know how it would work, because no one ever expected to have layoffs.” The layoffs have been few, but the hours of many full-time workers have been involuntarily cut to part time, she said.
Basically, transfusion medicine is 100 years old. In some sense the history of transfusion medicine tracks the history of recent modern medicine. Changes comes both rapidly and slowly. None of us practicing now has any recollection of what practice of medicine was like without transfusions, creating the illusion of a practice which has always been with us. However, the reality is it is a very recent addition to the ancient practice of caring for the sick and injured. Because of our biases, we are surprised when technology disrupts our world changes what we view as a practice which will be with forever.

The truth may very well be that use of blood is an expensive and labor intensive approach to care where the public will be best served if it can be replaced by approaches which are safer, cheaper, and simpler. Come to think about it, this sounds like the current health care system in general. Be prepared for change. Be prepared for disruption. Don't be surprised.

Friday, August 22, 2014

Would I want to be in GI training now?

First came the paper suggesting that flexible sigmoidoscopy (average cost $500-$750)  perhaps was as effective as  colonoscopy (10x the cost) in preventing colon cancer deaths. The FDA has recently approved the Cologuard test (FDA story) and Medicare wants to fast-track the approval of coverage. The estimated cost will be around the same as the cost for flexible sigmoidoscopy.

In the clinical trial Cologuard detected 92% of colorectal cancers (8% false negative rate) and 42% of precancerous lesions. The trial involved over 10,000 patients scheduled for screening colonoscopy, which subsequently identified colorectal cancer in 65 patients and advanced precancerous lesions in 757. The test reportedly has an approximately 13% false positive rate of diagnosis. Doing the math, this means that the test detected 60 of the 65 cancers and 325 of the adenomas. However, it was found to detect almost 70% of the adenomas believed to be most likely to progress to cancer. With a 13% false positive rate, this means that about 1300 people were found to be positive for the test who were clear on colonoscopy. 

How does this compare to fecal occult blood testing? Fecal immunological testing (FIT)  was 73% sensitive detecting only 48 cancers. However, it had only a 5% false positive rate.

Of course there are questions and doubters. In the LA Times, they quoted the head of the endoscopy unit at UCLA:
Dr. Bennett Roth, a professor of gastroenterology at UCLA, took a more measured approach to Cologuard. He said the test is still a work in progress, "but it's a move in the right direction." Roth said, is that it could encourage more people to have a colonoscopy, which remains the gold standard for diagnosing and treating colon cancer. "Maybe if you get a positive test with Cologuard, you'd be convinced to have the more definitive test," he said. "It doesn't replace the need for a colonoscopy."
I am not so sure I would interpret the results this way.  Colonoscopy is not without its issues. There is reported incidence of serious adverse events of 2.8/1000 procedures. Eight people per 10,000 patients screened will have a perforation. Hemorrhage occurs in 1-6 per 1000 colonoscopies.

Furthermore, colonoscopy is far from perfect (reference). The cancer miss rate (false negative) is reported to be as high as 6% and the adenoma miss rate for tumors greater than 1 cm is 12-17%. Perhaps some of the false positives detected by DNA testing may not be false positives at all?

I have news for Dr. Roth. Perhaps your position heading an endoscopy group has clouded your thinking about value. I cannot help but think that if I were to go and ask a president of a life insurance company about the value of life insurance, I might get a similar skewed perspective. Of course everyone should have life insurance!

I have had my colonoscopy when I was around age 50 and  soon enough someone will raise this with me again. Hmmm... let me think about this? There is a test available which is nearly as sensitive, with no prep, no anesthesia, no invasive risks, and it can be obtained at a fraction of the cost....Can you say no-brainer!

Let me do some additional math. This test roughly may eliminate the need to do over 80% of the $14 billion colonoscopy market. As Dr. Roth noted, perhaps this test may convince selected people to undergo colonoscopy, since 1/3 of the targeted screening group (50-75 year olds) are not screened. Even capturing this entire group, you would only expect perhaps 10% of these people to undergo colonoscopy.

I think any way you look at this this test represents a likely disruptive technology which will change the economics of GI medicine. Perhaps there are aesthetic medicine opportunities. Everyone else is doing it!

Sunday, August 17, 2014

Medicare care coordination payments

Medicare announced that it will begin to pay selected primary care physicians for care coordination beginning early next year. The article describing the announcement was published in the NY Times today. I welcome the idea that there is value in activities which happen outside of the office but as far as I can determine from the limited information available, the way that Medicare is undertaking deployment is seriously flawed.

It seems that the value to care coordination is assessed to be very modest with estimates of payments of about $42/month. The specifics of the deliverables is somewhat vague, with the exception being the requirement of 24/7 on call coverage. The language noted in the Times was:
Under federal rules, these patients will have access to doctors or other health care providers on a doctor’s staff 24 hours a day and seven days a week to deal with “urgent chronic care needs.”
Who knows what urgent chronic care needs might be? I suspect it will be defined as anything which is deemed urgent by the patient at any given point in time, which is a rather open ended commitment for 42 bucks per month.  However, if one has a large Medicare practice, it is not an insignificant sum of money which we are talking about. It is "concierge-iod" but at the low end of fees. At about $500/year, a practice which has 500 medicare patients will see an additional $250,000 per year. Is that enough to provide the additional services and enough left over for a bit or margin?

I have to raise the question as to whether now that Medicare offers this as a covered service, whether it makes the marketing of non-Medicare concierge services to Medicare patients  illegal?

While the story was reported on in major newspapers, I could not find anything on the CMS Website giving further details.  The one size fits all pricing fits with the typical contempt Medicare has with price signals in health care. It is an open invitation to cherry pick, assign the relevant chronic disease designations whenever possible, and look to amass the least sick, chronically ill populations that you can while developing the most effective strategies for avoiding patients who require after hours attention.

Let the games begin.. yet again

Economics always trumps evidence

One of the basic tenants of economics is that people respond to incentives. One of the most powerful incentives are monetary ones. As my oldest child describes this, "We are coin operated. "

Which brings me to a recent study published in JAMA - “Effect of Flexible Sigmoidoscopy Screening on Colorectal Cancer Incidence and Mortality“. This study demonstrated that screening patients with flexible signmoidoscopy decreases the incidence of colon cancer and death from colon cancer. It was a large study involving tens of thousands of people in Norway. This was the fourth study which showed similar effects. They were not huge in terms of absolute numbers, lowering the mortality from 4/1000 to 3/1000 over the 11 year interval in which patients were studied.

In the accompanying commentary by Allan Brett, the author points out that while flexible sigmoidoscopy demonstrates this benefit, the same has not been shown for colonoscopy, the more difficult, expensive, and risky approach to screening. Yet, colonoscopy has all but completely replaced the use of flexible sigmoidoscopy. Will this new information cause the pendulum to swing back toward use of the flexible sigmoidoscopy? I doubt it since the economics are so compelling.

As Dr. Brett notes in his commentary, patients are nudged by AGA guidelines identifying that the colonoscopy approach is the "preferred" strategy. Attempts to have a more nuanced discussion are really not feasible (likely true) and why not drive patients to the procedure that creates this highest margins? One does not need to be in the pocket of drug companies in order to be financially conflicted. You just need to be practicing medicine.

Perhaps it is not fair to single out the gastroenterologists,  since this type of thinking is absolutely rampant within current medical practice. It just seems that the economic underpinnings of this particular specialty may become unraveled rather quickly. As noted by Dr. Brett and in a cited piece by Stacey Butterfield in the ACP internist (Changes in colon cancer screening), next generation stool DNA testing may replace an expensive and cumbersome test with a simple stool test. I am sure that this will not happen without a real fight because as noted by David Lieberman, MD who was quoted in the ACP piece, "Colonoscopy has been really good to the specialty. It has been the goose that laid the golden egg".

I guess gooses don't live forever. The question is whether we should be working toward goose immortality.

Saturday, August 16, 2014

Everything you know is wrong

I recently read a book titled "The big fat surprise" by Nina Teicholz. In this book she reviews the history of low fat diets as a healthy approach to eating. As the pages turned, I could not help but recall the movie "Sleeper". In this movie,  Miles Monroe (played by Woody Allen), a jazz musician and owner of the 'Happy Carrot' Health-Food store in 1973, is subjected to cryopreservation without his consent, and not revived for 200 years. After waking his requests for breakfast are viewed with some disbelief.

Dr. Melik: This morning for breakfast he requested something called "wheat germ, organic honey and tiger's milk."
Dr. Aragon: [chuckling] Oh, yes. Those are the charmed substances that some years ago were thought to contain life-preserving properties.
Dr. Melik: You mean there was no deep fat? No steak or cream pies or... hot fudge?
Dr. Aragon: Those were thought to be unhealthy... precisely the opposite of what we now know to be true.
Dr. Melik: Incredible.
It seemed as though it was a joke when the movie aired in 1973 but the truth does not appear so humorous. The joke may have been on us for buying into what may very well be low fat nonsense. As the book describes, the origins of the diet which can be traced back to Ancel Keys, an American physiologist from mid 20th century. The book goes a long way into discrediting the purported science behind the diet, convincing me for one that perhaps significant harm has been foisted upon the American public. The data to support such a massive experiment upon the public was thin at best and perhaps better described as a massive fraud. The work represents a terrible indictment of the scientific peer review system as well, where peer review functioned only to squelch contrary (and what appear to be more accurate) opinions for over 60 years. I have already begun to change what I eat, incorporating more fat and in particular saturated fat. 

This particular set of dogma is not the only dogma now coming into question. Just this week there was a study published in the NEJM which followed more 100,000 people from 17 countries and found that those who consumed less than 3 grams of sodium a day had a 27% increased risk of death. The follows on the heels of a recent IOM report calling into question any cardiovascular or mortality benefits from lowering sodium intake below 2300 mg/day. The American Heart Association remains unconvinced, much as they remain unconvinced about issues with low fat diets. 

Although it garnered limited press, the Cochrane group reviewed studies which examined the benefits conferred from the treatment of mild systolic (140-159 mm Hg) or diastolic hypertension (90-99 mm Hg). (Cochrane Review) They reviewed studies including almost 9000 participants. They were able to demonstrate no effect on morbidity or mortality in the treated group and almost 10% of those treated had to discontinue treatment due to side effects. So why is aggressive treatment of BP in the demographic being used as a quality metric?

There is a theme here. In an attempt to improve the health of people, influential organizations have undertaken grand plans and schemes and based upon the trust which the public has placed in these organizations, massive campaigns have been undertaken. Driven by "hedgehogs" who pressed their agendas forward with little doubt they were doing the right thing, staggering numbers of people were the subjects of what amounts to be huge and uncontrolled experiments. Very disturbing...

Saturday, June 28, 2014

How best to communicate?

I had a very interesting conversation with colleagues tonight regarding optimizing communications within a health care network. It has always been a pet peeve of mine that communication networks among physicians tend to be very ad hoc in their functioning and information exchange. There was agreement within the group that something needed to be done. However, there was no consensus on exactly what optimal communication strategies should look like.

One of my colleagues who is an orthopedic surgeon, thought the best tool for his communication needs was the phone. It was his opinion that this approach afforded him with the fastest way to get the information he needed to ascertain whether he needed to see the patient or not and he was perfectly willing to use his time in a non-compensated fashion to avoid filling one of his new patient slots with a patient that would not feed his operative machine. For him, it seemed that the only reason to communicate with his fellow docs was to make sure that he did not interrupt the flow of good operative candidates into his office. There were merits in this communication approach in that it can address the concerns of primary care physicians and patients in real time and perhaps serves their immediate needs.

Still I have somewhat of a different perspective on the need for synchronous, real time communication, particularly by using the phone. When that encounter he describes is over, the only record of what was asked and what was said exists in various parties' minds. Presumably there was some sort of information shared with the consultant, some of which he heard, some of which he did not, and of the part he heard, there is some fraction of that he retained. In response, he made an assessment which was communicated to the consulting party, likely with a set a recommendations. What parts of the assessment and recommendations were heard and retained by the consulting physician shares the same limitations.

At some point, the assessment and recommendations get transmitted to some part of the medical record. I would venture to guess that at least part of this will be attributed to the physicians who gave his recommendations over the phone. How closely these track with what was said or intended is anyone's guess. Whether this note gets forwarded to the consultant is unlikely, meaning in some sense hearsay is documented in the medical record. Alternatively, nothing is recorded at all. It may be that none of this actually matters in that little or nothing was really at stake. Who really knows? We will never know since the record of this type of encounter and call will always be incomplete and error filled until we deploy software which records and parses everything we say and hear.

Am I being a nit picker about this? Is accurate communication important when dealing with someone's health? Imagine the legal system where a similar standard for communication was used? What is it about health care where we settle for spoken instructions and written records riddled with errors and imprecision?

I think this is part of a much larger issue regarding the best use of information to support decision making and coordination of care. Neither of these tasks are really priorities in the current world. Information collection is ad hoc. Decision making is very intuitive and system one based. In a world where there are few consistent feedback loops, any decision which is roughly equivalent in terms of financial outcomes becomes acceptable. Coordination of care is much talked about but also done in an ad hoc manner with no real rules of engagement. I talk to you and you talk to me. I think I hear what you tell me and you think that you hear what I tell you. I think I get what I want and you think you get what you want, and no one has any real idea of whether the patient gets what they need, unless their only priorities are to be dealt with quickly but not necessarily effectively. We prioritize speed and "efficiency" and that is what we get, nothing more and nothing less.

Thursday, June 26, 2014

Unbridled Power - The IRS and record keeping

The latest news regarding the IRS and emails reminded me of a book I read over 15 years ago titled "Unbridled Power: inside the secret culture of the IRS" by Shelley Davis. Ms. Davis was the first and likely last official historian of the IRS. She had a long career as a government historian, working for the Air Force and Defense Department Mapping agency before her employment at the IRS.

Throughout the federal government, there a professionals whose job is to manage documents in their agencies, reviewing them and forwarding relevant ones to the National Archives. This is what Mrs. Davis did in her previous roles in the Department of  Defense. When she arrived at the IRS she discovered that the IRS basically had no clear record retention policy and were engaged in a struggle with the National Archives to resist archiving IRS records. She testified to this effect to before the Senate finance Committee Oversight Hearing on Internal Revenue Service, Tuesday, September 23, 1997 (Shelley Davis Senate Testimony).
From her testimony:
My introduction to the culture of the IRS came during my earliest days with the tax agency, in the fall of 1988. Although I had been hired as the first historian for the IRS, I found little interest or support for my efforts. I found even less history. By history I mean both an awareness of the heritage of the IRS as well as the raw material (the documentation) from which narrative history is distilled. Neither the documents nor the heritage were to be found. Initially, I found this curious. Later, I found it alarming. At the IRS National Headquarters, there seemed little connection between the work of employees and actual tax collection what I presumed to be the mission of the IRS. Rather than possessing any basic curiosity about the past, the IRS employees I encountered exhibited a wariness, a suspicion assuming that anyone looking for records must have some definite agenda. An agenda presumed to be negative.
This reluctance to think about the past translated into routine day-to-day operations, meaning that all documents were tossed, shredded, whatever, when a program was completed or shut down, as in the case of many IRS computer projects. No records. No paper trail. No history.......
......A corollary to this defensive shield is the penchant of the IRS to destroy its paper trail. There were virtually no records of IRS actions throughout the twentieth century in any of the repositories where one would normally find federal records: the IRS itself, the National Archives (including the permanent archives in Washington, D.C., the 10 records centers around the country, or the Presidential libraries.)
In my early years with the IRS, a good question to ask was, "Where are the records?" What I learned was shocking. The records had been destroyed. Gone. Shredded. Tossed. They no longer exist due to a lack of attention to, or concern for, the law which requires all federal agencies to preserve records of what they do. It is as though the IRS assumed that laws which apply to the FBI, to the CIA, to every other part of the federal establishment can be ignored. No other agency of our government could get away with this. I questioned the reason why it had taken so long for anyone to realize that the records were not just missing, but destroyed. I believe the answer is based on fear. As taxpayers, why would we ever question the one agency that can truly bite back? 
Does this sound familiar? While at first I simply could not believe that the IRS could believe they could get away with such flagrant abuse of the law, I now realize that why shouldn't they believe so. They have been doing this for years. Shred paper documents or shred hard drives. What is the difference?

This has been going on for years. 1997 GAO report

Monday, June 23, 2014

Worth watching

All about what people want as opposed to what they need

and a contrary perspective:

Saturday, June 14, 2014

Telling people "You should not want that"

We are increasingly steeped in the evidenced based medicine culture. In a nutshell, this culture promotes interventions which we can demonstrate objectively that patients benefit from. Interventions which fail to demonstrate positive benefits are viewed with skepticism. I am very much a data driven person and I embrace the idea that if I am to push something as adding value to patients lives, I want to have a substantial degree of confidence that it really does accomplish this.

However, throughout the health care delivery system we are grappling with a very difficult problem. Patients frequently desire interventions which evidenced based enthusiasts believe provide them little or no value. We find ourselves taking time to convince patients that "You should not want this".

Our measurements and assessments are based upon the rational patient and doctor model. Measuring what we measure to assess value, we conclude that no rational person presented this evidence should want to have particular interventions or tests done. However, human needs are not always based upon rational desires and the value provided by a host of medical interventions and tests may not be what we think them to be. The actual value which patient derive may be based upon fears and wants which are emotionally based and have little or no basis in what we view as solid evidence of benefit.

As an example I can point out the entire industry based upon screening for early disease. Companies send mobile vans with testing equipment into a host of environments. The idea is there is the potential to reach patients who might benefit but because of accessibility issues, are not normally reached. However, those reached also who are already undergoing care who seek out these additional interventions because they provide some additional level of reassurance which they derive from the believe this action provides some additional protection from bad outcomes. Patients under the care of dermatologists go to skin cancer screenings, patients under the care of their internists get free PSA or lipid panels at the mall, and patients under the care of cardiologists pay additional sums to get a scan to look for calcium in their cardiac vessels from the van cruising their streets.

Another example is the recent decision of Medicare to cover gender reassignment surgery. This is the quintessential example of where human needs and wants are confused and confusing. There is absolutely no objective measure which can be used to justify this specific human desire, to change one's sex. If it is acceptable to say that there is a medical indication for this particular intervention  based upon this unique set of human desires, I am hard pressed to find any other human emotional desire which cannot be justified similarly. Whether one medical professional or another believes it unwise for a particular patient to desire a particular intervention based upon some sort of objective criteria becomes completely irrelevant, no matter what the data might show.

Based upon everything we know, patients should not want particular things but some (many?) do, because at an emotional level, these actions provide something which makes them feel better. This type of behavior is not unique to customers buying products in the health care arena. We purchase many products where either the product provides little or no objective benefit or we move to a higher end of the market to purchase higher priced variants which provide no greater objective value than the more basic products that can be obtained at steeply lowered costs.

We humans have desires which cannot be explained by the objective outcomes which can be measured. That we believe that the mechanisms to meet health care needs and wants can be segmented from the mechanisms we use to meet rest of human wants and needs is simply folly. We end up telling people that they shouldn't want things that they want, not really understanding their motivations and denying human nature.

Thursday, June 12, 2014

Telehealth and the absurdity of "place"

I have become very active in the delivery of health care via remote tools. This is one arena where the VA system is leapfrogging the civilian health care sector. The VA does not worry whether a telehealth encounter is billable. If it deliver the service faster at lower cost, so be it.

Our attempts to apply similar principles outside of the VA have been more challenging and shed light on a legacy model of care which is fixated on a host of details where are essentially divorced from actually adding value to patients. In order to fully appreciate just how off target these concerns are, it is helpful to simply step back and ask the questions:

1. What do we as physicians (and other health care workers) actually do which enhances our patient's lives?
2. What information do we need in order to succeed in these specific endeavors?
3. When communicating with patients and assisting them in making decisions, what approaches are optimal?
4. What role do direct, face to face encounters have in facilitating these activities which are central to delivery of services and adding value to our patients?

The last question is really the key one since the current payment system hold on to an uncompromising link between payment to the practitioner and some sort of real time and direct link to the patient. No face to face real time encounter, no payment. It prompts me to ask the obvious question, why? Is there overwhelming data that demonstrates that such an encounter is essential to the collection and processing of information critical for the diagnostic encounter or to the communication and shared decision making in a time frame most conducive to optimal care. I think not.

From my perspective, the hurried nature of the current models is awful. We force people to wait in "waiting rooms", waiting for their paltry 15 minutes of doctor time. The incentives are to try to do everything you can because any work done outside the confines of this frantic quarter of an hour does not count for billable work. Furthermore, it is all driven my how we are paid.

Current approved (billable) methods of telehealth drive to recapitulate the dysfunctional office encounters in the virtual world. We must stop thinking about telehealth in the terms and instead think about what we want to accomplish, what information do we need, how best to communicate, and which of those functions outlined above can be done remotely. The answer is basically all of them and they can be done better, as long as we stop trying to reconstitute the current model at a distance.

This perspective creates a whole new series of challenges relating to licensure. At this point in time, I still practice office based medicine. Patients come to me, where I practice in a state where I hold a license. However, some of these patients come from neighboring states. In addition, there are times where I may call them in follow up or communicate with them in some way. I may use a secure patient portal or my cell phone. I have no idea where they might be at the time and after they answer, I still have no idea where they are. I might be out of state when I answer and they might out of state or out of the country.

Does that mean I am in violation of state licensing laws, if I make diagnostic or therapeutic decisions and I happen not be be in the state where I am licensed at the time I am making these decisions? Similarly, if the patient who I am caring for is in another state when they are reading my instructions, is that a violation? Should they be required to come back into the state where I am licensed to read my instructions?

As the exchange of information and the delivery of care becomes less visit based and moves to a more continuous and remote data collection model, what is the meaning of the term "place" when discussing where care is delivered? Will we be required to put GPS devices on both our patients and ourselves and refuse to render care if either patient or provider is outside the licensed domain? Unless we freeze the current dysfunctional model in place, we are going to have to rethink state based licenses and the idea that care is delivered in one place.

Saturday, April 19, 2014

Making sure that everyone is rowing and in the right direction

I really enjoy courses I get from the Teaching Company. The two most recent ones I have listened to (and am currently listening to) are the courses on Behavioral economics delivered by Dr. Scott Huettel (Duke) and Why economies rise and fall taught be Peter Rodriguez (Princeton/UVA). These course have given me additional insights into the challenges I face personally and the challenges we face in aggregate in getting people motivated to create a better world for all.

In Dr. Rodriguez's presentations, he reflects upon human history to identify when and why specific peoples have thrived or failed. Improvement of our circumstances over time is completely dependent upon effective human action to increase productivity. It is through human action that we have lifted ourselves from abject poverty and misery. The more people who are working productively, the more wealth comes into existence, and the better off we are in aggregate.

When human operated primarily singly or in small groups, it was likely  not particularly hard to motivate individuals toward productive behavior. Without being individually productive, people went hungry, were exposed to the elements, and likely were miserable. However, as we moved more and more toward labor specialization and working in groups, it became easier for people to not be productive and potentially get away with this. Imagine a giant galley ship with millions of people all rowing. Suppose one stops rowing. Is that a big deal? What about if 1000 stop rowing? What about 100,000? At what point does the ship stop moving? At what point does the behavior of those not rowing entice a critical mass of those still rowing to stop?

Dr. Huettel's presentations in behavioral economics are focused on what motivates people to do things, including being productive and how cooperative behavior came to be and can be effective. Unlike the simple concept of productivity, human motivation and the tools to drive human action are extremely complex since they involve motivating people who are not entirely rational. Remarkably, we will engage in behaviors which will hurt ourselves if we perceive they will hurt potential free-riders even more (Altruistic punishment). Furthermore, this is not a unique human behavior and can be found in animals such as fish.

Understanding human motivation is devilishly complicated and just when you think you know how to manage a situation with a person or persons, everything changes. While human motivations is not just about money, money is a huge human motivator.  It occurred to me that the real function of money is it simply functions as a reasonably good marker of those who engage in productive behavior. Granted it is an imperfect marker but it perhaps is the best marker we have. Is it important for people to be engaged in productive activity? I would suggest it is critical since the aggregate well being of a population is directly related to the ability of those within the population to produce goods and services needed to make the lives of people better. There is a huge moral hazard associated with the widespread ability of people to game a system which allows them access to the products of the labors of others without needing to be productive themselves.

For those who decry those of us within affluent societies that feel driven to work hard and be productive, think of the alternative. We avoid misery and abject poverty because a critical mass of the population feels obligated to some degree to engage in activities which provide value to other people. To undermine the incentives which motivate that segment of the population is to undermine the foundations of the institutions that lift people out of poverty. The default mode in the world is still life on the edge.

Sunday, April 13, 2014

Being blind to human wants

I do not watch much television but there are a few programs that capture my attention. A few years ago I got
hooked on "Deal or no deal". I was fascinated by the decisions made by contestants and their reasons for decided as they did. I saw it as a trove of data which would ultimately serve to someone's doctoral thesis in behavioral economics. Now I am fascinated by "Shark Tank" and what draws me to this is the laser focus of the sharks, the venture capitalists and how any given product or service will meet the wants of the public. Whatever you might feel about any of the sharks as people, you have to admit they are gifted in terms of seeing what the public might desire and spend their own precious treasure to acquire.

The last episode I watched highlighted a pair of inventors who developed what I thought was a remarkable
product, one that converted boiling water into electricity. I thought it was an extremely cool technology. However, most of the sharks were not so turned on to it because they thought the markets in the US would be limited. Most of them really disliked the idea of camping and thought their views were representative of the public at large. I could not help but think of my experiences in Haiti where such a device would be extremely useful and the discussion ultimately focused in on this. Mark Cuban asked about whether the inventors had considered developing world applications, which they had. Everyone on the panel thought that people in these circumstances would use this device primarily to charge small battery operated devices such as cell phones This was also the initial thought of the inventors. However, they were surprised to discover that when they inquired, their potential customers desired something else; they wanted the capacity to generate electricity to produce lighting. They were less concerned about charging their cell phones and more interested in prolonging daylight. Everyone on the panel thought they understood what their customers wanted until they asked them.

There is a lesson here for those of us to are in health care. One characteristic of the current delivery system is that our patients, our customers, baffle us by not doing what we recommend. We call this non-compliance. There are impressive numbers floated regarding the scope the problem: 20-30% of prescriptions are never filled and around half are not taken as prescribed. The knee jerk reaction among those of us within the medical fraternity (sorority) is that this behavior is a marker of some sort of  basic human character flaw which warrants remedial training. I would suggest that it may me more indicative that we are trying to sell a product which our patients for which they detect little value.

There are data which support this contention. It has been demonstrated that reducing the copays on medications increases patient compliance. This is consistent with the value theory I propose. If the interventions proposed by us cost substantially more than nothing, patients make the assessment that even at nominal cost they do not provide sufficient value to their lives to make the investment of their own resources.  The articles in the medical literature for the most part make it a given that the interventions we recommend are slam dunks and no one but fools would decline them. Of course you want a parachute when you jump out of an airplane! Duh!  I would suggest the data are not so compelling.  The truth may be substantially more nuanced. As noted in a NYT blog piece by By DANIELLE OFRI, M.D. (Orfri blog, Nov 2012):

“It’s an immense oversimplification” to reduce compliance to whether or not a patient swallows a pill, says the author, Dr. John Steiner, a researcher at Kaiser Permanente in Colorado.
To illustrate his point, he constructed a chart for a theoretical 67-year-old patient with diabetes, hypertension and high cholesterol and tabulated what it would take to be “adherent” with all medical recommendations.
Besides obtaining five prescriptions and getting to the pharmacy to fill them (and that’s assuming no hassles with the insurance company, and that the patient actually has insurance), the patient would also be expected to cut down on salt and fat at each meal, exercise three or four times per week, make it to doctors’ appointments, get blood tests before each appointment, check blood sugar, get flu shots – on top of remembering to take the morning pills and then the evening pills each and every day.
Added up, that’s more than 3,000 behaviors to attend to, each year, to be truly adherent to all of the doctor’s recommendations. Viewed in that light, one can see how difficult it is for a patient to remain fully compliant.

This perspective does not even begin to touch upon the question of whether patients are even close be being convinced they derive value from any of this.  Like the sharks described above who thought they knew what wants motivated their target populations, we are often clueless as to what wants drive our patient decisions. However, unlike the sharks who generally have proven masterful in understanding human wants and have become wealthy because of this, the culture of health care delivery has historically tended to ignore what patients want and focused primarily on what we think they need. In some sense it is remarkable we get as much buy in from our patients as we do. While 20-30% of patients may not fill their prescriptions, that means that 70-80% fill them.

In order to better get our hands around these issues, let's take a hypothetical example from outside of the health care industry. Imagine that you find that your old computer is slow and runs on Windows XP, no longer supported by Microsoft. You have heard about security risks and decide to investigate whether a new machine is in order. You go to a big box retailer (Best Buy) to look into the purchase of a new computer and try to explain to the sales associate what you think you need. The salesman immediately directs you to the highest end machine they sell and also tries to sell you an extended warranty. When you balk, believing that the high end investment does not actually bring you the value you need, the salesman suggests that you are ignorant and calls you "non-compliant". He points out to you that you obviously don't understand the risks involved in buying a cheaper machine or sticking with an obsolete XP operating system. There is much at stake here with your valuable photos and financial records which all could be lost if you are not covered with an extended warranty. People lose their valuable data every day! We will just mark your Best Buy customer record with the "Non-compliant" check mark.

We in health care are involved a service industry. We need to realize that recent history has placed this service industry within a very peculiar  financial environment which has insulated many if not most of its customers from many of  the actual costs of service delivery and thus has created a perverse set of incentives and a skewed set of perspectives on the value placed by patients upon the services we deliver. However, as the cost of the medical services becomes increasingly transferred on to patients, it appears patients perhaps value the services we offer much less than we thought they would or should.  This comes as a surprise to those of us delivering the services since our impressions of value have formed by seeing demand within an environment of almost no cost to those demanding the service. Raise the price just a little and oh how the demand seems to evaporate. Perhaps we should try harder to convince patients that what we offer really does bring them value, convincing them to sped their time and resources on what we recommend. That can be viewed as education and/or marketing but the onus is on us, not on our patients. We should work hard to ask them what they they view their needs to be, where their priorities are, and what they want. We will need to be prepared for answers we do not expect or want to hear.

Sunday, April 6, 2014

Physician as craftsman

Physicians operate as craftsmen. We are organized into guilds and use the power of the state through licensing laws to keep competitors out. We train new practitioners using the apprentice model. We link our pay to directly touching our products, one at a time, whether it be in the operating room, the exam room, and less so in the lab or reading room.  We understand that people love craftsman and are suspect of things that are mass produced. We resist mass production in medicine.  However, we tend to lose sight of the fact that our standard of living and life expectancy has improved remarkably over the past 300 years because we have moved from craftsman produced goods and services to mass produced items. We can value craft items now only because mass production has made us wealthy enough to have the disposable income to acquire such luxuries.

Still we maintain medicine as a craft industry and place the most expensive craftsman (us) in the center of delivery. Can we afford to continue to do this? We have deployed increasingly complex sets of interventions and recommendations where the yield from the complexities are marginal. The increase of complexity has been
underwritten by insurance which has for the most part has insulated the consumer from the cost increases, until now. Obviously patients have liked this situation because they are insulated from costs. Deliverers of care have liked this situation because it has allowed them to deliver increasingly complex and expensive (high margin) care without the risk of sticker shock. Furthermore, this could all be delivered without disrupting the craftsman model of care, until now.

Throughout history fields controlled by craftsman have evolved away from the craft model. The major transitions and disruptive innovations were generally not driven by craftsman. It is hard to imagine that medicine will be any different. Craftsman, including physicians, are loathe to drive innovation which will disrupt their status and livelihoods. Furthermore, physicians tend to value their services to patient more than patients value them. In contrast, patients value convenience and cost more than those delivering the services. This disconnect in terms of value has been hidden due to a payment system which insulates those receiving the services from the full costs.

The time and convenience value issue is coming to the forefront. The use of various surveys of patients probing their impressions of the experience of care delivery almost invariably highlights convenience issues. It appears that patients may value convenience and cost more than they value quality. Patients can be just as happy or happier with cheap and good enough as opposed to the best.  Our responses as medical professionals historically has been like the old phone company, "We don't care because we don't have to". Addressing patient priorities has not been our priority because, unlike our patients, we value quality of the care we deliver more than convenience of delivery. What will happen when other non-craftsman parties who get into the health care delivery business have priorities which align more closely with what patients want more (cheaper, good enough, and convenient) than what we physicians believe they should desire (the best quality possible)? I believe the results are predictable.

Furthermore, the craft model of health  care delivery looks increasingly like a trap. The exploding cost of care now exerts substantial price pressures which physicians have responded to by increasing volume and through put. However, there are limits to how fast one can run the craft model. It is not particularly scalable and by insisting we touch every patients, we become bottlenecks, and expensive ones at that. The product we attempt to deliver becomes more and more divorced from what the public desires.

What is a craftsman to do? Should we remain true to our ancient craft or should we embrace new non-craftsman based care models recognizing different priorities?  If we have interventions and delivery approaches which can reach more people at lower cost and make lives better, we should strive to deploy them in ways which are affordable and scalable. However, our training programs are based upon the legacy of apprenticeship of the craftsman and guilds. Should training programs be the bastions of past, are we preparing our trainees for a world which is not likely to exist in the future with skills sets that the public is not particularly interested in using? The key question becomes, will physicians lead movements driving change, be dragged kicking and screaming into new models, or simply be bypassed and left behind?

Wednesday, April 2, 2014

What is science without replication?

Dr. Mina Bissell published a commentary in Nature in November (Reproducibility Risks) which was in response to questions raised by a study by Amgen scientists where they could only reproduce 11% of work published in high impact journals. She took what I view as a very peculiar tack on these observations. Her major concern was that the drive to improve the reproducibility of research findings could serve as a stumbling block to  promising research and researchers. She believed her concerns were justified based upon the time required and the technical difficulties associated with reproducing studies:
"People trying to repeat others' research often do not have the time, funding or resources to gain the same expertise with the experimental protocol as the original authors, who were perhaps operating under a multi-year federal grant and aiming for a high-profile publication. If a researcher spends six months, say, trying to replicate such work and reports that it is irreproducible, that can deter other scientists from pursuing a promising line of research, jeopardize the original scientists' chances of obtaining funding to continue it themselves, and potentially damage their reputations."
"Many scientists use epithelial cell lines that are exquisitely sensitive. The slightest shift in their microenvironment can alter the results — something a newcomer might not spot. It is common for even a seasoned scientist to struggle with cell lines and culture conditions, and unknowingly introduce changes that will make it seem that a study cannot be reproduced."
My question is how biologically relevant are observations if they are only reproducible under very narrow and difficult to replicate (impossible to replicate?) circumstances? Shouldn't one's reputation be somewhat dependent upon doing and reporting scientific studies which others can replicate? Substitute the term magic for science and wizard for scientist. Magic and alchemy became discredited because it was not reproducible and it was dependent upon special proprietary talents held as secrets by the purported practitioners. Where have we gone if our models begin to resemble magic tricks or at best difficult to duplicate scientific parlor tricks?

What brought this to light was the biotech company Amgen invested a huge sum of money and the product of their investment was not what they expected (Begley). The rest of us in the biomedical establishment should understand what they uncovered. Prior to their work, we had no way of measuring the quality of biomedical research work in terms of a metric which is central to research in general: reproducibility. One must assume that when they undertook this endeavor, they were not intentionally testing the reproducibility hypothesis. I can only imagine this was believed to be a given since it is so central to research activities.

To be faced with a reproducibility percentage which almost reached into single digits must have been staggering to the Amgen scientists. How can this be?  The assumption that scientific work is self correcting does not appear to be valid.  Thus, Dr. Bissell's response to this is to find all sorts of reasons that under the current circumstances with complex systems that reproducible findings are hard to generate. She misses the point. If we have arrived at a place where only one in ten studies published in the most reputable journals can be reproduced, we have an awful quality control problem in science. It is likely worse than these numbers reveal since these results come from the most reputable journals.

Given the extent of the problem highlighted by the Amgen work, one must also wonder how much of this problem may be due to scientific fraud. I came across a report of an investigation in Germany published in 2000 (Hermann and Brach) regarding two cancer scientists who operated in Germany in the 1980's and 1990's. The commission that investigated them and found rampant issues. However, little structural action has been taken to address the underlying problems. It is sad to admit but humans functioning in science will be representative of people in general. If money, fame, power are involved, some will stretch the rules and in the absence of mechanisms to identify undesirable activities, the culture will devolve into whatever it takes to be successful in the increasingly competitive funding climate.  The Wikipedia page on scientific misconduct continues to expand (WIKI).

This is simply unacceptable. The fact that any attempt to address these observations will be disruptive of current operations should be taken as a given, not as a barrier. How valuable is this multi-billion dollar enterprise if the models only work is a few hands and there are no consistent quality control tools? The arguments placed are highly reminiscent of the points put forth when the safety and quality movement came on the scene in health care delivery. Prior to the late 1990's it was difficult to track quality in health care delivery. Thus, consistent with the mantra that if you can't measure it, you cannot improve it was operational. Since there are few incentives to measure reproducibility in biomedical sciences, few focus on this. What the field values in general is productivity, whether valid and reproducible observations are made or not is of secondary value. I fear that the absence of  reproducibility feedback loops has taken us to a very undesirable place from the stand point of those investing financial resources in the research.

Dr. Bissell offers a few anecdotes from her lab to refute the concerns. When sophisticated scientists in industry spending hundreds of millions of dollars cannot duplicate your work, they might have a problem in that they burned through resources that could have been better invested elsewhere. However, if they cannot reproduce your results you have a bigger problem.  The fact that under the current system that this issue can be viewed as someone else's problem is a HUGE PROBLEM. One cannot and should not deflect the onus on someone else. Magicians and wizards can resort to secret spells and incantations. That is not science.

Sunday, March 30, 2014

Taking oaths of poverty...Not!

Those who deliver health care often express a very conflicted view of money in their profession. No one admits to being in it for the money. Yet,  I have yet to hear of any of my colleagues commit to an oath of poverty. There is a desire to live well enough, but what is enough is open to interpretation. That figure has different anchors from which various parties base their perception of what is good but not greedy.

What creates almost constant tension is the concern that the sources of the money, which drives the engines that are health care, make a difference. There are assumptions and perceptions about these sources which tend to go unquestioned, which I question. They include:

1. Money from commercial sources is unclean and corrupting.
2. Money from grants from non-profits or the state are not corrupting
3. Revenues from clinical practice are OK, unless somehow corrupted by funds from for profit entities

We have gone through various cycles of self reflection, accepting and rejecting funding partnerships with for profit entities, particularly pharmaceutical companies. In my opinion, the tensions arise because we make assumptions which simply are not true and can never be true. Institutions which deliver key services to people will always be less than perfect. The most important piece to recall is that the void left behind when key institutions fail is almost always worse than when they exist but function imperfectly.

I experience and try to direct a modestly sized operating unit which provides service to patients, training to various learners, and drives scholarly and performance improvement work. All of these endeavors require fuel, that is money. That is because those participating in these activities are almost exclusively "coin operated". Missions which provide their own margins are the easiest to sustain. Those which don't are at risk of going away, despite perceptions that they are important. Money is not everything but for activities which require the commitment of parties who require financial incentives to come to work, the economics become very uncompromising in a hurry.

Thus, what is the impact when we start to be picky about the sources of funds to support missions. I call into question the hierarchy of sanctity of fund sources as noted above. Wherever the money comes from will cloud our judgement. Yes, taking funds from commercial sources has its risks. I would argue that these risks can be mitigated by explicit transparency as to where the money comes from, how much was transferred, and where the funds went. I have seen the effects of the virtual complete cessation of industry money into medical training programs. We primarily used these funds to buy books and support small research projects. The hit occurred at the very time our other funding options became more limited. Our goals and missions are at times aligned with commercial entities such as drug companies. We should recognize this and use this alignment to maintain a differentiated source of funding.

The health delivery system and particularly academic health systems, have seen the federalization of their funding sources. I recently asked on of our finance heads what percentage of our revenues come from the federal government. They remarked that this was a very good question but they did not know off hand. I am fairly sure it is a large and growing percentage. Whether it be research grants, Medicare funds, Medicaid dollars passed through state middle men, or tuition backed by federal loans, a large percentage of key funds comes from a single source. Not such a good business model for long term sustainability in my opinion.

Furthermore, the assumption that federal or other state monies do not influence our thinking or behavior is to be questioned. These monies are by definition monies disbursed with primarily political considerations in mind. With money, there is always an underlying quid pro quo and with political monies, the payback must be something which has political value. In my opinion, the political leanings of academic health centers reflects the influence of federalization of the funding process. We have created an insular culture with few dissenting voices, which drives the expansion of state power in health care. It is unfortunate that the entire model based upon a narrowing source of funding becoming more and more sole source based is likely to prove unsustainable.

Finally, we derive huge sums of revenue from clinical activities. I am always annoyed when I read articles in clinical journals where authors claim they have not financial conflicts, yet the articles center around clinical activities which serve as their major source of revenue. Are we blind? If the intervention described in the paper focuses on a procedure which creates substantial margins to support you and your operating unit, is this not a fundamental financial COI, even you work for a non-profit entity?

If we are driven to a great degree by financial concerns (and we are), it really does not matter where the money comes from. Each source of money will create biases and blind spots, and influence our behaviors in both subtle and not so subtle ways. The effects will vary depending upon the sources but all sources provide incentives for both desirable and not so desirable behaviors. The beliefs that certain sources of funds are always substantially more corrupting than others is mistaken. Wherever the funds come from to support important missions, the rules in place with always drive certain parties to behave in less than virtuous ways, whether the monies derive from commercial or political activities. We cannot meet our missions without the financial resources unless we get buy in regarding oaths of poverty from those involved. That is not going to happen. We might as well be realistic and tap into robust and differentiated funding sources which includes both commercial and non-commercial sources to create a sustainable model.