As the globe faces a novel, highly transmissible,
lethal virus, I am most struck by a medicine cabinet that is embarrassingly
empty for doctors in this battle. This
means much of the debate centers on mitigation of spread of the virus. Tempers flare over discussions on travel
bans, social distancing, and self quarantines, yet the inescapable fact remains
that the medical community can do little more than support the varying
fractions of patients who progress from mild to severe and life threatening
disease. This isn’t meant to minimize the
massive efforts brought to bear to keep patients alive by health care workers
but those massive efforts to support failing organs in the severely ill are in
large part because we lack any effective therapy to combat the virus. It is akin to taking care of patients with
bacterial infections in an era before antibiotics, or HIV/AIDS in an era before
It should be a familiar feeling for at least
one of the leading physicians charged with managing the current crisis – Dr.
Anthony Fauci. Dr. Fauci started as an
immunologist at the NIH in the 1960s and quickly made breakthroughs in
previously fatal diseases marked by an overactive immune response. Strange reports of a new disease that was
sweeping through the gay community in the early 1980’s caused him to shift
focus to join the great battle against the AIDS epidemic.
Even this cardiologist knows why. The not so subtle evidence lies in the cloudy
lens in front of his pupils. He is
afflicted with cataracts that obstruct his vision to the point he can’t really
do his job refurbishing antique furniture safely. His other problem is that he hates doctors.
He hasn’t had reason to see one for more than a decade. He’s 68, takes no medications, smokes a pack
of cigarettes a day, and is a master of one word answers. He’s in my office because
he needs a medical evaluation prior to his cataract procedure. Someone needs to
attest to medical safety. I’m it.
He just wants to get out of here.
His annoyance of being in the office is
justified. Cataract surgery is very low
risk. Unless he’s having an acute
medical problem, there is little to do.
The problem is that in an age of high volume, super specialized care,
the eye doctor can’t attest to this, and the anesthesiologists have little
interest in finding out the morning of his procedure that Mr. Smith has been
having more frequent episodes of chest pain over the last two weeks. Perhaps the chest pain is just acid reflux,
or maybe it’s because of a pulmonary embolism related to the tobacco induced
lung malignancy no one knows about. It’s possible, and highly likely, Mr. Smith
will survive his cataract surgery even if
he has a pulmonary embolism.
Cataract surgery really is pretty low risk.
But the doctor’s ethos has never been to
‘clear a patient for a cataract’, it is to commit to the health of the
patient. Mr. Smith deserves the
opportunity to receive good medical care that isn’t made threadbare just
because of the cataract surgery on the horizon.
It took some doing, but I had finally
made it to Bobby’s home.
It was a rowhome tucked into one of those
little side streets in the city that non-city folks wouldn’t dream of driving
down. As I step in, I’m met by the usual set up – wooden steps that hug the
right side of the wall leading up to the second floor. Bobby certainly hasn’t made it up to the
second floor in some time. At the moment she is sitting in her hospital bed in
the living room. The bed is the focal point to a room stuffed to the gills with
all manners of stuff. At least three quarters of the stuff seems to be food.
Cinnamon buns, Doritos, donut holes, chocolate frosted Donuts, crackers,
Twinkies. The junk food aisle at Wawa would be embarrassed by the riches on
Bobby weighs in at four hundred pounds, 5
foot 5 inches. She has a tracheostomy from multiple prior episodes of
respiratory failure that have required ventilatory support. I’m here at the
request of a devoted primary care physician that still makes home calls. I’ve
looked through the last number of hospital stays. The last few discharge
summaries are carbon copies of each other. Hypoxemic respiratory failure
related to pulmonary edema complicated further by morbid obesity. Time on the
vent. Antibiotics. Diuretics. Home. Return to the hospital 2 weeks later. The
last echocardiogram done was 3 admissions ago. A poor study. Not much could be
seen due to ‘body habitus’.
I sit on the side of the bed trying to acquire my own images of her heart. I talk to her as I struggle. Bobby is 58, the youngest of three sisters, and the only surviving member of the family. Her elder sisters died of respiratory complications as well. They both died with tracheostomies. The conversation is circular. The problem according to Bobby is the tracheostomy. Everything was fine before that. I explain that a prolonged period of time on the ventilator on a prior admission prompted the tracheostomy, and that the multiple recent admissions to the hospital that required a ventilator seemed to validate that decision. She doesn’t waver. Both her sisters died shortly after they got tracheostomies. Bobby thinks the physicians taking care of her sisters had a hand in their demise. “They didn’t care.” “We told them they were sick.”
It is commonly believed that deliberate, careful price regulation by enlightened technocrats trumps the haphazard and chaotic regulation of prices imposed by the free market—especially when the market is subject to greed and corruption.
A most interesting case study challenging that belief comes courtesy of the largest Democracy in the world: India.
In 2017, an arm of the Indian Government, the National Pharmaceutical Pricing Authority (NPPA) took action to control the price of coronary stents in India by capping their retail price. The problem that stimulated this action was their exorbitant price that made them unaffordable to many Indians.
The retail prices of US made drug-eluting stents ranged from Rs 80,000 – 150,000 (~$1000 – ~$2000), while the price of Indian made drug-eluting stents ranged from Rs 45,000 – 90,000 (~$600 – ~$1200). Considering that a good job for 90% of the Indian labor force pays about Rs 180,000 per year, these prices put most coronary stents out of the reach of a vast swath of the populace.
What regulators knew, however, was that the price point at which coronary stents were being imported into India was a fraction of the price being charged to Indians. The up-charge had everything to do with what happened after the stent was brought onto Indian soil: The Indian subsidiary of the US stent manufacturer would sell its product to a domestic distributor that would then employ all means necessary to ensure their stent was chosen by cardiologists to be implanted.
The message comes in over the office slack line at 1:05 pm. There are four patients in rooms, one new, 3 patients in the waiting room. Really, not an ideal time to deal with this particular message.
“Kathy the home care nurse for Mrs. C called and said her weight yesterday was 185, today it is 194, she has +4 pitting edema, heart rate 120, BP 140/70 standing, 120/64 sitting”
I know Mrs. C well. She has severe COPD from smoking for 45 of the last 55 years. Every breath looks like an effort because it is. The worst part of it all is that Mrs. C just returned home from the hospital just days ago.
The day after NBC releases a story on a ‘ground-breaking’ observational study demonstrating caramel macchiatas reduce the risk of death, everyone expects physicians to be experts on the subject. The truth is that most of us hope John Mandrola has written a smart blog on the topic so we know intelligent things to tell patients and family members.
A minority of physicians actually read the original study, and of those who read the study, even fewer have any real idea of the statistical ingredients used to make the study. Imagine not knowing whether the sausage you just ate contained rat droppings. At least there is some hope the tongue may provide some objective measure of the horror within.
Data that emerges from statistical black boxes typically have no neutral arbiter of truth. The process is designed to reveal from complex data sets, that which cannot be readily seen. The crisis created is self-evident: With no objective way of recognizing reality, it is entirely possible and inevitable for illusions to proliferate.
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…
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.
It turns out overutilization in the US healthcare system isn’t what its cracked up to be.
Figure 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.
As CVS-Aetna merger talks fill the air this Christmas season and experts weigh in on the impact this will have on the economy and consumers alike, I’m sitting at a little desk in a little office contemplating health insurance.
I run a little shop that’s about as far from CVS-Aetna as you can get in the health care space : a solo practice doctor with four full time employees and revenues a little south of $65 billion dollars. I shouldn’t feel too alone. Small businesses account for 99% of US firms and employ almost half of all private sector employees. But knowing my problem is one shared by many provides only partial solace.
Prior to arrival of the ACA, I provided health insurance to everyone through the company. At the time I had 3 full time employees and the insurance broker I worked with got me a quote for $1300 / month. Now, I really didn’t want to be in the providing healthcare business, so when the ACA arrived with its individual market I was happy to facilitate buying health insurance from the exchanges. So initially, I chose to pay for my employees plans on the individual market. I was quickly told by my accountant that paying for my employees insurance in this manner was running afoul of a three letter entity of the federal government called the IRS.
Apparently the individual ACA market premiums were allergic to being deducted in this pre-tax manner. Fine. So I went ahead and paid each employee $6000 per year extra with the understanding that they would use that money to buy health insurance on the individual market.
I’m sitting amidst a number of cardiologists to go over the most recent trials presented at the interventional cardiology conference in Denver. The cardiology fellow presenting goes quickly through the hors de oeuvres until finally getting to the main course – ORBITA.
ORBITA sought to test the very foundations interventional cardiology was built on – the simple idea that opening a stenosed coronary artery was good for patients. The trial was a double blind randomized control trial of patients with tightly stenosed arteries who either had a stent placed or had a sham procedure. Before the results are presented, the lay media headlines from cardiobrief, the New York Times, and the Atlantic are presented to guffaws from the audience. The indignant smirks are audible as the accompanying editorial remarks from Rita Redberg and David Brown are displayed :
”The results of ORBITA show unequivocally that there are no benefits for PCI compared with medical therapy for stable angina, even when angina is refractory to medical therapy.”
The trial results follow – no statistically significant difference in the primary outcome of exercise time increment between sham and stent, and no difference in angina between the two groups. The meat of the presentation involves the limitations of the trial that make the trial inapplicable – 200 patients total, 6 week follow up, the underlying heterogeneity of the patient angiograms that were randomized, and the wide confidence intervals of the primary outcome that swallowed the actual effect size. Two different angiograms were shown to the audience from the ORBITA appendix.
The images demonstrate two ‘blockages’. To the eye, at least, one appears tighter than the other. The audience was polled on each image – everyone voted to stent the tighter blockage and medically manage the lesser of the blockages. It could be all perception but I could feel the relief in the room as ORBITA was being made irrelevant. The implication clearly was that some angiograms used to show the lack of benefit from stents would not have needed stenting in the first place.
There was no real challenge to the presenter save for one:
“One of the authors – Rita Redberg – is very sharp – why do you think she wrote that editorial?”
There was no good answer – the presenter shrugged and muttered something about an anti-interventional cardiology bias.
It was at that moment that I realized why cardiologists were having such trouble with ORBITA – we were arguing like puritans. Everyone in the room already ‘knew’ stents worked. This was an exercise in bias confirmation when what was needed was an examination of the source of bias. Faced with the ultimate epistemological challenge we were resorting to authority to dismiss findings we didn’t like. Now I think cardiologists have authority with good reason, and certainly ORBITA may have limitations inherent in any small randomized control trial that’s performed, but we can do a better job answering the fundamental question raised here that relates to the primary evidence opening a narrowed artery actually can relieve angina.