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Misdiagnosis: Obamacare Tried to Fix the Wrong Things and Prescribed the Wrong Treatments

Today THCB is happy to publish a piece reflecting the learnings from Charles Silver and David Hyman’s forthcoming book Overcharged: Why Americans Pay Too Much For Health Care, shortly to be published by the libertarian leaning Cato Institute. In subsequent weeks we’ll feature commentary from the right radical libertarian zone on the political game board (Michael Cannon) and from the left (Andy Slavitt) about the book and its proposals. For now please give your views in the comments–Matthew Holt

There are many reasons why the United States is “the most expensive place in the world to get sick.” In Part 1 of Overcharged: Why Americans Pay Too Much For Health Care, we show that the main reason is that we pay for medical treatments the wrong way. Instead of having consumers purchase these treatments directly, we route trillions of dollars through third-parties payers – both government and private insurers.

Relying on third party payers has many consequences — few of them good. To start with, this arrangement removes the budgetary constraint that would otherwise cap the amount consumers are willing to spend. By minimizing the direct cost of treatments at the point of sale, third party payment arrangements alter everyone’s incentives fundamentally. Consumers no longer need worry about balancing marginal costs against marginal benefits; instead, they have an incentive to use all treatments that have any potential to help, regardless of their prices. When millions of consumers act on these incentives, total spending skyrockets and consumers collectively wind up worse off, because their fixed costs spiral upward too. Heavy reliance on third party payers creates a classic failure of collective action.

It isn’t just consumers. Providers love third party payment as well. And why not? Once providers have access to the enormous bank accounts of third party payers, the sky is the limit, at least until third party payers start setting limits on the amounts they will pay and saying no to unproven and/or cost-ineffective treatments that doctors want to provide and patients want to receive.

Not surprisingly, it has turned out to be extraordinarily difficult and politically unpopular for third party payers to set such limits. Obamacare’s appeal derives largely from two requirements: health insurance plans must accept all comers, including applicants with preexisting conditions that require expensive medical treatments; and health plans must provide unlimited benefits (i.e., no annual or lifetime spending caps). From an individual consumer’s perspective, what could be better than having access to unlimited amounts of money to spend on medical needs? From society’s point of view, though, this combination is a recipe for disaster.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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The verdict is in: All three of CMS’s “medical home” demonstrations have failed

Between September of 2016 and last month, CMS released “final evaluations” of all three of its “medical home” demonstrations. All three demos failed.

This spells bad news not just for the “patient-centered medical home” (PCMH) project, but for MACRA. The PCMH, along with the ACO and the bundled payment (BP), is one of the three main “alternative payment models” (APMs) within which doctors are supposed to be able to find shelter from the financial penalties inflicted by the MIPS (Merit-based Incentive Payment System) program which was recently declared to be unworkable by the Medicare Payment Advisory Commission. Medicare ACOs and virtually all Medicare BP programs are also failing. Thus, we may conclude what some predicted a long time ago – that neither arm of MACRA (the toxic MIPS program and the byzantine APM program) will work.

In this post I describe each of CMS’s three PCMH demos, review the findings of the final evaluations of the three demos, and then explore the reasons why all three demos failed. I’ll conclude that the most fundamental reason is that the PCMH is so poorly defined no one, including the doctors inside the PCMHs, knows what it’s supposed to do. That’s not to say that the hopes and dreams of PCMH proponents were never clear. They have always been clear. PCMH proponents have said over and over the PCMH is supposed to lower costs and improve care. But a clear expression of hopes and dreams is not the same thing as a clear description of what it is you’re dreaming about.Continue reading…

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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Bringing “care” back to healthcare by caring about those who care

In the depths of winter, America was shocked by the video of a young, bruised and confused woman being discharged from a Maryland Hospital – alone into the cold night, wearing nothing but a thin hospital gown and socks. Hospital security officers dropped her at the nearby bus-stand and then briskly wheeled away the chair in which they had brought her out, deftly avoiding the questions of a concerned citizen who bore witness to this inhumane act. Most healthcare workers in the U.S., physicians and nurses, allied health professionals, and janitors alike felt a wretched sadness watching the video, recognizing as they did another sign of the sickness that ails the healthcare system today.

As our culture has become increasingly more consumeristic, healthcare has become increasingly more commercialized. A “provider interaction” has become a commodity; and hospitals have become the factories producing that commodity. This has shifted the balance of power from healthcare providers to professional managers. This change, ostensibly done to provide doctors more time to practice their art, instead has insidiously but surely changed the culture of our healthcare institutions.

The daily-lived values of our institutions have changed from the core values of medicine – caring, compassion and empathy for the patient, to more corporate values of productivity metrics and profits. What was to be a properly balanced socio-economic model for hospitals has gone tragically wrong. The goal was efficacy – efficient and effective patient-centric care. However, the disproportionate focus on efficiency, achieved by applying industrial engineering and productivity standards to patient care, has compromised effectiveness. More importantly, this has eroded the core of patient-centric care – compassion and empathy. That the CEO of the Maryland hospital insisted that the patient was provided appropriate medical care, even as he acknowledged the failure of humanity and compassion, sadly demonstrates that compassion and empathy are no longer the core values of healthcare.

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Double Standards, Trojan Style

The University of Southern California (USC) appears to look the other way when male physicians harass or assault women. In reality, sexual violence spares no occupation, including medicine, but the way an organization responds to crime against women indicates a certain level of integrity. The World Health Organization estimates sexual violence affects one-third of all women worldwide. In a nation where women make up 50% or more of each incoming medical school class, only sixteen percent of medical school deans are female, making gender imbalance in leadership positions nearly impossible to overcome.

For the second time in less than a year, USC President C.L. Max Nikias is grappling with sexual misconduct allegations against a physician faculty member. Complaints go back to the early 1990s from staff and patients about inappropriate comments and aggressive pelvic exams done by Dr. George Tyndall, the only full-time gynecologist for the past three decades at the campus clinic. USC ignored complaints until a nurse contacted the campus rape crisis center.

Dr. Tyndall was initially suspended pending inquiry and forced to resign shortly thereafter. More than 100 complaints have been received and five are suing USC.Continue reading…

The Ethics of Keeping Alfie Alive

By SAURABH JHA

Of my time arguing with doctors, 30 % is spent convincing British doctors that their American counterparts aren’t idiots, 30 % convincing American doctors that British doctors aren’t idiots, and 40 % convincing both that I’m not an idiot.

A British doctor once earnestly asked whether American physicians carry credit card reading machines inside their white coats. Myths about the NHS can be equally comical. British doctors don’t prostate every morning in deference to the NHS, like the citizens of Oceania sang to Big Brother in Orwell’s dystopia. Nor, in their daily rounds, do they calculate opportunity costs for keeping patients alive on ventilators.

Conversations such as this are vanishingly rare.

Administrator: “It’s costing an arm and leg keeping this sick baby alive – to balance the annual budget we need to stop dialyzing a granny.”

ICU doctor: “We’ll have to send poor Ethel to her grave. That’s a shame. She was beginning to grow on me.”

Health Ethicist: “Wait, let me check with National Institute of Clinical Excellence, the rationing experts, who should be relieved of intensive care first. Perhaps it should be Winston, not Ethel – because Winston is an alcoholic. We need to make rationing scientific and fair.”

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Will Cancer Drugs Ever Be As Affordable As Retrovirals in Low and Middle Income Countries?

In 2014, the majority of international health aid was dedicated to HIV. So, one might reasonably assume that this is the largest health problem facing the world. Yet, HIV only constitutes 4% of the global burden of disease. In 2014, noncommunicable diseases (NCDs) made up 50% of the entire disease burden, but only received 2% of all global health funds.

The disease burden of NCDs is fast outpacing that of infectious diseases. Despite this, the proportion of global health financing dedicated to combatting NCDs has remained constant over the past 15 years at 1 to 2%.

Currently, 32.6 million individuals are living with cancer (diagnosed in the last five years). In 1970, 15% of new cases were in low- and middle-income countries. In 2008, 56% were in low- and middle-income countries. By 2030, this proportion is expected to be 70%. So, not only is the burden of NCDs rising globally, but it is also beginning to disproportionately affect countries with the least resources to deal with them.

But, if NCDs have been steadily increasing in low- and middle-income countries, why has global action not followed suit? Continue reading…

The Case For Real World Evidence (RWE)

Randomized control trials – RCTs – rose to prominence in the twentieth century as physicians and regulators sought to evaluate rigorously the performance of new medical therapies; by century’s end, RCTs had become, as medical historian Laura Bothwell has noted, “the gold standard of medical knowledge,” occupying the top position of the “methodologic heirarch[y].”

The value of RCTs lies in the random, generally blinded, allocation of patients to treatment or control group, an approach that when properly executed minimizes confounders (based on the presumption that any significant confounder would be randomly allocated as well), and enables researchers to discern the efficacy of the intervention (does it work better – or worse – than controls) and begin to evaluate the safety and side-effects.

The power and value of RCTs can be seen with particular clarity in the case of proposed interventions that made so much intuitive sense (at the time) that it seemed questionable, perhaps even immoral, to conduct a study. Examples include use of a particular antiarrhythmic after heart attacks (seemed sensible, but actually caused harm); and use of bone marrow transplants for metastatic breast cancer (study viewed by many as unethical yet revealed no benefit to a procedure associated with significant morbidity).

In these and many other examples, a well-conducted RCT changed clinical practice by delivering a more robust assessment of an emerging technology than instinct and intuition could provide.

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