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Cardiologist, Private Practice

Mrs. Verma Goes to Washington

By ANISH KOKA MD 

Seema Verma, the Trump appointee who runs Medicare, has had an active week. The problem facing much-beloved Medicare is one that faces every other government-funded healthcare extravaganza: it’s always projected to be running out of money. Medicare makes up 15% of the total federal budget. That’s almost $600 billion dollars out of a total federal outlay of $4 Trillion dollars. The only problem here is that revenues are around $3.6 trillion. We are spending money we don’t have, and thus there there is constant pressure to reduce federal outlays.

This is a feat that appears to be legislatively impossible.  The country barely is able to defund bridges to nowhere let alone try to reduce health care spending because, as everyone knows, any reduction in health care spending will spawn a death toll that would shame the black plague. The prior administration’s health policy wonk certified approach was to change the equation in health care from paying for volume to paying for value. This, we were assured, would allow us to get better healthcare for cheaper! And so we got MACRA, The Medicare Access and CHIP Reauthorization Act, that introduced penalties for doctors unable to provide ‘good’ care. Never mind that in some years good care means you treat everyone with a statin, and in others it means treat no one with a statin. When in Rome, live like the Romans. In 2018 parlance, that roughly translates to “check every box you can and everything will be all right.”Continue reading…

Expensive Hospitals: The Enemy Within

By ANISH KOKA MD

Everyone agrees that health care is bankrupting the nation. The prevailing winds have carried the argument that a system that pays per unit of health care delivered and thus favors volume over value is responsible. The problem, you see, was the doctors. They were just incentivized to do too much. This incontrovertible fact was the basis for changes in the healthcare system that favored hospital employment and have made the salaried physician the new normal. Yet, health care costs remain ascendant.

Why?

It turns out overutilization in the US healthcare system isn’t what its cracked up to be.

utilizationFigure 1. Utilization rates in different health care systems

A recent analysis (Figure 1) by Papanicolas et al., in JAMA demonstrates that while the United States is no slouch with regards to volume of imaging and procedures in a variety of different categories, it does not explain a health care system twice as expensive as its nearest competitor. The problem turns out not to be volume, rather its the unit price of healthcare in the United States.

Health Care Costs and Glass Houses

There are many stones cast by all the various players in healthcare when it comes to cost, and of course, everyone bears some degree of responsibility, but it’s also clear that some folks live in larger glass houses than others. The most beautiful of all the glass houses are those built by hospitals. From 1996 to 2013, it was not population growth, health status, doctors visits, or prescription drugs that drove spending increases. Sixty-three percent of the increase in cost over an almost 20-year time span can be attributed to hospital stays and testing during doctor visits. Consider that the average hospital stay in the US costs $18,142, and lasts 4.9 days compared to other industrialized countries where average hospital stays last 7.7 days, and cost $6,222. But despite these exorbitant prices hospital systems in the United States complain they barely stay afloat.

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Does Free Medical School Decrease Social Justice?

BY ANISH KOKA, MD

The hottest medical school in the country right now is the New York University School of Medicine thanks to the gift of a generous benefactor that promises to make medical school free for all current and future medical students.  The news was met with elation from the medical community of physicians that groans frequently about student debt loads routinely north of $200,000 upon matriculation.  Not surprisingly, the technocrat class of public health experts and economists did not share in the jubilation.  The smarter-than-the-rest-of-us empiricists are, after all, trained to think in terms of social justice and net benefits to society.   The needs of medical students are far down the list of priorities when forming this social justice utopia.

Contemporary arguments for social justice in some form or the other trace their roots to the philosopher John Rawls and his 1971 magnum opus – “A Theory of Justice”.  In words that would infuse liberal thought for a generation, Rawls laid out a blueprint for a just society by proposing a thought experiment called “the original position”.  This was a hypothetical scenario where a group of people are asked to form the rules of a society which they will then occupy. The catch is that the people making the decision do so behind a ‘veil of ignorance’ not knowing the disadvantages conferred by any number of attributes (age, sex, gender, intelligence, beauty, etc. ) they may be reincarnated with. Rawls posited that under conditions in which there was a possibility of being born as a disadvantaged member of society, social and economic inequalities would be arranged to be of greatest benefit to the least advantaged members of society.

At first glance, it would seem that the objections to tuition-free medical school rest on a social justice framework that does not seem to comport with gifts to the soon-to-be-wealthy.  After all, the $200,000 investment for medical school pales in comparison to the lifetime earnings of the average physician who is assured at least a six-figure income in seeming perpetuity. But it is not entirely clear that one has to even combat Rawlsian ideals to rebut the social justice do-gooders with strong opinions on how other people should spend their money.  A Rawlsian framework never intended that everyone in society would be able to achieve the same outcome regardless of starting position.  Rawls actually went out of his way to argue that inequalities were justified in society as long as the operating rules served to raise the position of those worst off in society.  A rising tide should lift all boats – the rich may become richer, as long as the poor become richer as well.

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The Evidence Crisis: Causal Inference – Don’t be a chicken (Part 3)

By ANISH KOKA

Part 1

Part 2

Physicians have been making up numbers longer than people have been guessing weights at carnivals.  How much does this statin lower the chances of a heart attack? How long do I have to live if I don’t get the aortic valve surgery?

In clinics across the land confident answers emerge from doctors in white coats.  Most of the answers are guesses based on whatever evidence about the matter exists applied to the patient sitting in the room.  The trouble is that the evidence base used to be the provenance of experts and anecdotes that have in the past concluded leeches were good for pneumonia.

And so came the randomized control trial to separate doctors from homeopaths.  Random assignment seeks to achieve balance between two groups for everything but the treating variable to isolate the effect of the treatment.  But does randomization really guarantee a balance between groups?  At least the known confounders may be measured in the two groups, but what about unknown confounders?

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The EBM Wars: When Evidence has a Price – The ECMO Trials (Part 2)

By ANISH KOKA

The year was 1965, the place was Boston Children’s and a surgery resident named Robert Bartlett took his turn at the bedside of a just born baby unable to breathe.  This particular baby couldn’t breathe because of a hole in the diaphragm that had allowed the intestines to travel up into the thoracic cage, and prevent normal development of the lungs.  In 1965, Robert Bartlett was engaged in the cutting edge treatment of the time – squeeze a bag that forced oxygenated air into tiny lungs and hope there was enough functioning lung tissue to participate in gas exchange to allow the body to get the oxygen it needed.  Bartlett persisted in ‘bagging’ the child for 2 days.  As was frequently the case, the treatments proved futile and the baby died.

The strange part of the syndrome that had come to be known as congenital diaphragmatic hernia was that repairing the defect and putting the intestines back where they belonged was not necessarily curative.  The clues to what was happening lay in autopsy studies that demonstrated arrested maturation of lung tissue in both compressed and uncompressed lung.  Some systemic process beyond simple compression of one lung must be operative.  It turns out that these little babies were blue because their bodies were shunting blood away from the immature lungs through vascular connections that normally close off after birth.  Add abnormally high pressures in the lungs and you have a perfect physiologic storm that was not compatible with life.

Pondering the problem, Bartlett wondered if there was a way to artificially do what the lungs were supposed to do – oxygenate.  Twelve years later in 1977, while most pediatric intensive care units were still figuring out how to ventilate babies, a team lead by Bartlett was using jerry rigged chest tube catheters to bypass the lungs of babies failing the standard treatments of the day.  In a series of reports that followed, Bartlett described the technique his team used in babies that heretofore had a mortality rate of 90%.  A home made catheter was placed in the internal jugular vein and pumped across an artificial membrane that oxygenated blood before it was returned via a catheter to the carotid artery.  The usual hiccups ensued.  The animal models didn’t adequately model the challenges of placing babies on what has come to be known as ECMO (Extra Corporeal Membrane Oxygenation).

bartlett1977

Patient 1 developed a severely low platelet count, hemorrhaged into the brain and died. Patient 2 survived but was on a ventilator for 7 weeks.  Patient 3 developed progressive pulmonary hypertension and died.  Patient 4 died because of misplacement of one of the ECMO catheters.

The team improved, and mortality in this moribund population improved to 20%.  The pediatric journals of the day refused to publish the data because they felt ECMO for neonates was irresponsible.  Once published, the neonatology community came out in force against ECMO, and some penned editorials implying the children only became supremely ill because Bartlett’s team was incompetent.  The team persisted, as is anyone that is driven by the desperate need of patients.  None of this should be surprising.  The constant battle between skeptics and proponents is a recurring theme known to anyone with even a limited understanding of  medical history.  But this is where the story goes off the rails.Continue reading…

The EBM Wars: Manufacturing Equipoise (Part 1)

By ANISH KOKA

The phone rings.  It’s not supposed to be ringing.  It’s 2 am.   The voice on the other line is from an apologetic surgery resident.

Resident: There is this patient..

Me: Yes, go ahead. Please.

Resident: He’s tachycardic.

Me: How fast?

Resident: 160 ?

Me: What’s the blood pressure?

Resident: 130/90

Me: Rhythm?

Resident: An SVT I think.. I gave adenosine.  Nothing happened

Me: Audibly groaning.  I’ll be in..

Forty five minutes later I’m at the bedside of a decidedly ill appearing man.

I want to be triumphant that his heart rate is only 145, and a quick glance at the telemetry monitor above his bed uncovers juicy p waves in a cadence that suggests this is no primary electrical arrhythmia.

Something is very wrong somewhere – the heart in this case is an innocent bystander being whipped into a frenzy to compensate for something.

At the moment the whip is a norepinephrine infusion being used to keep his blood pressure up.

I ask the nurse if the amount of norepinephrine infusing has been stable.  She replies that his dose has been slowly escalating.

Eureka! I think – the heart rate response in this case is being driven by the norepinephrine – a powerful adrenaline that acts on beta receptors and alpha receptors within the body that increase heart rate and constrict the blood vessels to raise blood pressure.  Fix the cause of the low blood pressure, come down on the norepinephrine, and perhaps the heart rate would be better.

But it turns out this particular post surgical patient doesn’t have a medical cause of low blood pressure I can find.  I cycle through cardiac ultrasounds, blood gases, steroid and volume challenges, and try inching down on the norepinephrine.

All of it is to no avail.  I’m growing more and more convinced this problem is surgical in nature. Perhaps an infarcted piece of bowel?  All I know is that the man acts like he has no peripheral vascular tone.

An interesting thing happens shortly after.  The norepinephrine drip runs out.

As one nurse runs to get another bag from the pharmacy – a quick cascade of events unfolds.

The brisk upstroke from the arterial line that marks the pressure wave generated with every beat of the heart starts to dampen.  The color seems to visibly drain from the patients face, and he begins to complain that his vision is getting blurry.  His systolic blood pressure is 70 – an almost forty point drop within a minute of the norepinephrine running out.

I call for help.

I try to keep a level tone.  Project control, not panic.

“Open the code cart, I need a half a milligram of epinephrine”

“You’re going to be ok, sir.  Hang with me.”  I squeeze his hand.

He closes his eyes

The code cart – a fully stocked cabinet on wheels with almost everything you need for resuscitation efforts – is wheeled into the room. The epinephrine vial is handed to the nurse, and hurriedly pushed.

Within seconds, I can see the blood pressure and heart rate rise.  The patient’s grip on my hand relaxes.  Or maybe its my grip on his hand.  I forget which.  His vision returns to normal as his blood pressure ‘normalizes’.

Of course nothing has been fixed.  Why his blood pressure remains low continues to be a mystery.  The bag of norepinephrine soon isn’t enough even at its maximal dose.  The same scenario (hypotension -> pallor -> vision loss ) recurs 30 minutes later, and another bolus of epinephrine aborts a rapid spiral towards pulselessness.

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Fighting Hubris in Medicine

By ANISH KOKA

The weekend started with a tweet about an elderly man with atrial fibrillation.  Atrial fibrillation is an arrhythmia of the heart that predisposes those who suffer with it to strokes.  The strokes are a  result of clots being thrown from the heart into the brain.  The typical treatment for this condition in those deemed high enough risk is to thin the blood to help prevent these clots from forming, and thus reducing the risk of stroke.

The problem with thinning the blood is that the risk of bleeding increases, and it does so especially as one advances in age.  It doesn’t help matters that the risk of having a stroke also increases with age.

In a 101 year old deciding on the best course of action is thus a challenging one.  It is easiest when patients are adamant about a certain path.  Far be it from me to tell a centenarian what to do.   In this case, the man who had been alive for two world wars chose to come off the anticoagulant he had been dutifully prescribed.

I queried the audience

Most leaned towards stopping Pradaxa, and some responded that there wasn’t a wrong answer.

I asked the question because this was a decision that had been made four years earlier.  The consequences of that decision were playing out now.

No one lives forever.  In a parallel world, the anticoagulant continues and this is a discussion about the brain hemorrhage that resulted.  These aren’t the only two possibilities. He could also have avoided both types of stroke, attended a few more great grand kids birthdays and passed away in his sleep from a cardiac arrhythmia.

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A Tale of 2 FDAs

By ANISH KOKA

Frances Oldham Kelsey by all accounts was not mean to have a consequential life.  She was born in Canada in 1914, at a time women were meant to be seen and not heard.  Nonetheless, an affinity for science eventually lead to a masters in pharmacology from the prestigious McGill University.  Her first real break came after she was accepted for PhD level work in the pharmacology lab of a professor at the University of Chicago.  An esteemed professor was starting a pharmacology lab and needed assistants, and the man from Canada seemed to have a perfect resume to fit.  That’s right, I said man.  Frances was thought to be a man’s name, and the acceptance letter accepted Mr. Frances Oldham.  Given the times, her Canadian mentor advised the young Frances she not write to inform the Chicago professor of the mistake but to simply sign the acceptance letter as Miss Oldham.  The rest, as they say, is history.  Ms. Frances Oldham arrived in Chicago in 1936, and just two years later was asked to work on figuring out what caused one of the worst poisonings in American history by the nascent US Food and Drug Administration (FDA).

The FDA at the time was a small organization within the federal government that had come into being a few decades earlier after the passage of one of many progressive laws passed to protect consumers from rapacious pharmaceutical companies of the day.  At the time there was no standard for claims that could be made to an unsuspecting public and no requirement that drug companies specify what ingredients were being consumed by the public.  The companies of the day would take alcohol, water and coloring mixed together – give the formulation a name, get a US patent, and make millions by heavily marketing testimonials of cures to all that ails directly to the consumer.  At one point, it was estimated that there was more alcohol being sold via ‘patent medicines’ than at liquor stores.

Sadly, it was not medical professionals that put a stop to this, but muckraking journalists like Samuel Hopkins Adams who exposed the seamy underside in a series of articles for Collier’s Weekly entitled The Great American Fraud.   Popular outrage followed publication of this series in 1905 and in response, the first draft of the FDA came into being by order of Congress in 1906.

The initial purpose of the FDA was a small, but important one – ensure the correct labeling of drugs being sold to the public.  The 1906 act – fought tooth and nail by industry – mandated that ingredients such as alcohol, cocaine, heroin, morphine and cannabis be accurately labeled with contents and dosage.  To understand the scope of the problem at the turn of the century, understand that Coca-Cola (Coke) was sold initially as a ‘patent medicine’ that was marketed as a cure for headaches, impotence, morphine addiction as well as a number of other ills.  The main ingredients?  Cocaine and Caffeine.  Current drinkers of Coke will be happy to know that cocaine was eliminated from the formula in 1903.

The FDA as we know it now is a result of the passage of the Federal, Food, Drug and Cosmetic Act (FFDCA) of 1938 that came as a reaction to national tragedy in 1937 that once again drove home the point that the public needed protection from private corporations.   The matter was a simple one that involved an ingredient that actually worked – sulfanilamide.  Sulfanilamide was an antibiotic that killed bacteria by preventing the synthesis of Folic Acid.  Humans are relatively primitive and don’t make Folic acid – so it isn’t toxic to humans.  That is, unless you’re the chief chemist of  S. E. Massengill Company, and you create a preparation of sulfinilamide that is dissolved in di-ethylene glycol (DEG).  DEG is toxic to humans – the first case reports of toxicity had been reported six years earlier.  Unfortunately the chemist, Harold Watkins, who worked for the company was unaware as this was not widely known at the time.  Watkins simply added some raspberry flavor to the sulfa dissolved in DEG, and the company founded by a Tennessee medical student who saw more opportunity in selling drugs to doctors than practicing medicine started distributing the drug widely.  No animal studies or any type of premarket testing was required at the time, and so the drug went straight from the lab to the consumer.  More than a hundred people died.

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The Barbershop Study: How an Unorthodox Study on Black Men’s Health Brought Down the House and Where It Went Wrong

The study that changed everything was published last week.  An alien visiting the national cardiology meeting in Orlando may have thought that the trial of note was the one that featured the culmination of one hundred years of lipid research to develop an inhibitor of the enzyme PCSK9 (Proprotein convertase subtilisin/kexin type 9) that lowers lipids and reduces the risk of future heart attacks.

The Martian would be wrong.

The trial that has cardiologists across the land choking back tears is a hypertension study done in black barbershops.  The idea is fairly simple.  Black men have the highest rates of disability related to uncontrolled hypertension, in large part related to a difficulty in engaging black men with the health care system.  The end result of poorly controlled hypertension in this community was on full display where I did much of my medical training as a student and resident in the heart of North Philadelphia.  Ensconced in the walls of Temple we learned to manage the end organs ravaged by hypertension.  I have to say I never stopped to think what we could have done to interrupt this process even though we were located in the heart of an underserved black community.

Luckily, Ronald Victor has been thinking about this problem for some time.  A Cedars Sinai physician, his research focuses on community interventions to rectify health care disparities.  His first study in 2007 sought to examine the feasibility of blood pressure screenings in black barbershops because this was where black men congregated and may be susceptible to influence by important peer influencers: barbers.

The 2007 study by Victor proved that it was feasible to enlist barbers to measure blood pressures, correctly stage hypertension, and make a referral to a clinician for treatment.  This opened up funding for the next step in the process- actually affect blood pressure control in barbershops.  The trial was wildly positive.  In stark contrast to the multibillion dollars of research that lead to a $1000/month PCSK9 inhibitor that gives us a 15% relative risk reduction of a composite outcome of stroke/death/heart attack, the Victor barbershop protocol resulted in a staggering average 27mmHg blood pressure drop in 6 months.  The potential ramifications are large for a 20mmHg drop – a 30% reduction in risk of a heart attack or a 40% reduction in risk of a stroke.

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The Price of Progress

No one knows who Bennie Solis is anymore.

He had the misfortune of being born in the early 1960s marked for death. He had a rare peculiar condition called biliary atresia – a disease defined by the absence of a conduit for bile to travel from his liver to his intestinal tract. Bile acid produced in the liver normally travels to the intestines much like water from a spring travels via ever larger channels to eventually empty into the ocean. Bile produced in the liver with no where to go dams up in the liver and starts to destroy it.

That the liver is a hardy organ was a fact known to the ancient Greeks who told the tale of the punishment given to the god Prometheus for stealing fire from the gods. Chained to a mountain, an eagle would feast on his liver by day. The liver would regenerate by night to allow the eagle a full meal on its return making this a truly eternal punishment.

So it is that the poisoned human liver remarkably continues to function to allow beautiful appearing normal children to be born. It would make the eventual discovery of the disease all the more painful. How could that beautiful child harbor something so black inside?

When Bennie was born, every child with his condition had one fate. Death.

And it did not come slowly. As the liver becomes progressively damaged and scarred, the flow of blood through the liver is impeded. The obstructed blood, seeking a way to return to the heart, travels through collateral channels. These vessels, normally minute and invisible in the esophagus and the stomach, now become engorged and thin walled and prone to rupture. Complicating matters even further, the body lacks clotting factors that were normally synthesized by the liver, giving blood the consistency of water. The horrors only multiply. Blood pours from the mouth and rectum when vessels rupture, free fluid fills the abdominal cavity, the lack of bile in the intestine means fat isn’t absorbed, and the body starves. When death mercifully does intervene, it arrives as the liver completely loses its ability to manage toxins, sending the children into a coma.

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