Friday, July 20, 2018

OP-ED

OP-ED

A Clinical Trial By Any Other Name …

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Mosquito borne illnesses pose a significant threat to human health. In the past several years, drug makers have begun developing vaccines for viruses like dengue, Zika, and chikungunya, all of which pose unique risks to billions across the globe. One of them just went terribly, terribly wrong.

Sanofi Pasteur, the vaccine division of the multinational pharmaceutical company Sanofi, has the problem. In a press release distributed last Wednesday, Sanofi reported that new analysis of long-term safety data for its dengue vaccine, Dengvaxia®, revealed that the vaccine may not be safe or effective for individuals who have had no prior dengue infection. The Philippines was the first country in Southeast Asia to approve the vaccine. It has since been administered to more than 600,000 schoolchildren in three highly-endemic regions of the country in the world’s first public dengue immunization program.

The vaccine received regulatory approval in the Philippines in December 2015, and the school program took effect just over three months later. Numerous local public health officials have claimed that the program was initiated too hastily. Susan Pineda Mercado, the former undersecretary of the Philippine’s Department of Health (DOH), has characterized the program in a Facebook post as “the biggest government funded clinical-trial-masked-as-a-public-health-program scam in the history of the DOH.”

Orbiting ORBITA

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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.

How the Republican Tax Cuts Will Impact the Health Care System

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The U.S. tax system and health care are deeply intertwined. The Republican tax bills hurtling through Congress would make significant changes in this relationship.

The proposed changes, primarily a large cut in the corporate tax rate from 35 to 20 percent, would benefit health care (and most other) companies.

But none of the changes would, in the long run, benefit consumers, the public good, or public health. The major components of the proposed legislation are dangerously ill-conceived and ill-timed in the context of the overall economy and in particular health care policy and spending, which is projected to comprise 20 percent of the nation’s economy in 2025, up from 18.3 percent today.

That’s a difference and increase that reflects several trillion dollars of “additional” health care spending over the next decade. Amid this projected rise, the Trump administration and congressional Republicans propose to reduce the rate of growth of overall federal government spending and shift a sizable portion of health spending to other government entities and programs. These include the Pentagon, national security, homeland security, infrastructure projects, and—most notable in the context of the tax bills—a tax cut for corporations and upper income Americans.

It doesn’t and won’t add up—unless two (unlikely) things happen: (1) the economy grows at twice to three times the rate most economists predict and (2) the rate of growth in health spending is dramatically constrained.

Absent both, the Republican tax bills will cause the annual federal budget deficit and the nation’s long-term debt to balloon even more than already forecast.

Why “Precision Health” May Not Be the Precise Word

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The appeal of precision medicine is the promise that we can understand disease with greater specificity and fashion treatments that are more individualized and more effective.

A core tenet (or “central dogma,” as I wrote in 2015) of precision medicine is the idea that large disease categories – like type 2 diabetes – actually consist of multiple discernable subtypes, each with its own distinct characteristics and genetic drivers. As genetic and phenotypic research advances, the argument goes, diseases like “type 2 diabetes” will go the way of quaint descriptive diagnoses like “dropsy” (edema) and be replaced by more precisely defined subgroups, each ideally associated with a distinct therapy developed for that population.

In 2015, this represented an intuitively appealing idea in search of robust supporting data (at least outside oncology).

In 2017, this represents an intuitively appealing idea in search of robust supporting data (at least outside oncology).

The gap between theory and data has troubled many researchers, and earlier this year, a pair of cardiologists from the Massachusetts General Hospital (MGH) and the Broad Institute, Sek Kathiresan and Amit V. Khera, wrote an important – and I’d suggest underappreciated – commentary in the journal Circulation that examined this very disconnect, through the lens of coronary artery disease (CAD).

Practicing Medicine While Black
(Part II)

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Managed care advocates see quality problems everywhere and resource shortages nowhere. If the Leapfrog Group, the Medicare Payment Advisory Commission, or some other managed care advocate were in charge of explaining why a high school football team lost to the New England Patriots, their explanation would be “poor quality.”

If a man armed with a knife lost a fight to a man with a gun, ditto: “Poor quality.” And their solution would be more measurement of the “quality,” followed by punishment of the losers for getting low grades on the “quality” report card and rewards for the winners. The obvious problem – a mismatch in resources – and the damage done to the losers by punishing them would be studiously ignored.

This widespread, willful blindness to the role that resource disparities play in creating ethnic and income disparities and other problems, and the concomitant widespread belief that all defects in the US health care system are due to insufficient “quality,” is difficult to explain. I will attempt to lay out the rudiments of an explanation in this essay.

In my first article in this two-part series, I presented evidence demonstrating that “pay-for-performance” (P4P) and “value-base purchasing” (VBP) (rewarding and punishing providers based on crude measures of cost and quality) punish providers who treat a disproportionate share of the poor and the sick.

The P.A. Problem: Who You See and What You Get

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Recently, the New York Times published an article on excessive costs incurred by mid-level providers over-treating benign skin lesions. According to the piece, more than 15% of biopsies billed to Medicare in 2015 were done by unsupervised PA’s or Nurse Practitioners. Physicians across the country are becoming concerned mid-levels working independently without proper specialty training. Dr. Coldiron, a dermatologist, was interviewed by the Times and said, “What’s really going on is these practices…hire a bunch of P.A.’s and nurses and stick them out in clinics on their own. And they’re acting like doctors.”

They are working “like” doctors, yet do not have training equivalent to physicians. As a pediatrician, I have written about a missed diagnosis of an infant by an unscrupulous midlevel provider who embellished his pediatric expertise. This past summer, astute physician colleagues came across an independent physician assistant, Christie Kidd, PA-C, boldly referring to herself as a “dermatologist.” Her receptionist answers the phone by saying “Kidd Dermatology.”

The Doctors, a daytime talk show, accurately referred to Ms. Kidd on a May 7, 2015 segment as a “skin care specialist.” However, beauty magazines are not held to the same high standard; the dailymail.com, a publication in the UK, captioned a picture of “Dr. Christie Kidd”, as the “go-to MD practicing in Beverly Hills.”

The article shared how Ms. Kidd treats the Kardashian-Jenner family, “helping them to look luminous in their no-make-up selfies.”

Health Care Needs Its Rosa Parks Moment

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On Wednesday, October 25, 2017 I was at the inaugural Society for Participatory Medicine conference. It was a fantastic day and the ending keynote was the superb Shannon Brownlee. It was great to catch up with her and I’m grateful that she agreed to let THCB publish her speech. Settle back with a cup of coffee (or as it’s Thanksgiving, perhaps something stronger), and enjoy–Matthew Holt

George Burns once said, the secret to a good sermon is to have a good beginning and a good ending—and to have the two as close together as possible. I think the same is true of final keynotes after a fantastic conference. So I will do my best to begin and end well, and keep the middle to a minimum.

I have two main goals today. First, I want to praise the work you are doing, and set it into a wider context of the radical transformation of health care that has to happen if we want to achieve a system that is accountable to patients and communities, affordable, effective — and universal: everybody in, nobody out.

My second goal is to recruit you. I’m the co-founder of the Right Care Alliance, which is a grassroots movement of patients, doctors, nurses, community organizers dedicated to bringing about a better health system.  We have 11 councils and chapters formed or forming in half a dozen cities. I would like nothing more than at the end of this talk, for every one of you to go to www.rightcarealliance.org and sign up.

But first, I want to tell you a bit about why I’m here and what radicalized me. My father, Mick Brownlee, died three years ago this Thanksgiving, and through his various ailments over the course of the previous 30 years, I’ve seen the best of medicine, and the worst.

My father was a sculptor and a scholar, but he was also a stoic, so when he began suffering debilitating headaches in his early 50s, he ignored them, until my stepmother saw him stagger and fall against a wall in the kitchen, clutching his head. She took him to the local emergency room, at a small community hospital in eastern Oregon. This was the 1970s, and the hospital had just bought a new fangled machine—a CT scanner, which showed a mass just behind his left ear. It would turn out to be a very slow growing cancer, a meningioma, that was successfully removed, thanks to the wonders of CT and brain surgery. What a miracle!

Fast forward 15 years, and Mick was prescribed a statin drug for his slightly elevated cholesterol. One day, he was fine. The next he wasn’t, not because his cholesterol had changed, but the cutoff point for statin recommendations had been lowered. Not long after Mick began taking the statin, he began feeling tired and suffering mild chest pain, which was written of as angina. What we didn’t know at the time was the statin was causing his body to destroy his muscles, a side effect called rhabdomyolysis. Even his doctor didn’t recognize his symptoms, because back then, the drug companies hid how often patients suffered this side effect.

The statin caught up with Mick at an exhibit in Seattle of Chinese bronzes, ancient bells and other sculptures that my father had been studying in art books his whole career. Halfway through the exhibit, he told my brother to take him home; he was too tired to take another step.

Three days later, he was in the hospital on dialysis. The rhabdomyolysis had finally begun to destroy his kidneys. Three weeks later, he was sent home alive with one kidney barely functional. Soon his health would begin to deteriorate at a steady pace.

The Great American Hypertension Epidemic of 2017

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On November 15, 2017, an epidemic of hypertension broke out and could rapidly affect tens of millions of Americans.  The epicenter of the outbreak was traced back to the meeting of the American Heart Association in Anaheim, CA.

The pathogen was released in a special 488-page document labeled “Hypertension Guidelines.”  The document’s suspicious content was apparently noted by meeting personnel, but initial attempts to contain it with an embargo failed and the virus was leaked to the press.  Within minutes, the entire healthcare ecosystem was contaminated.

At this point, strong measures are necessary to stem the epidemic.  Everyone is advised not to click on any document or any link connected to this virus.  Instead, we are offering the following code that will serve both as a decoy and as an antidote for the virulent trojan horse.

Only a strong dose of common sense packed in a few lines of text can possibly save us from an otherwise lethal epidemic of nonsense.  Please save the following text on your EHR cloud or hard-drive, commit it to memory or to a dot phrase, and copy and paste it on all relevant quality and pay-for-performance reports you are asked to submit.

What Baseball Can Teach Doctors

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Baseball, like medicine, is deeply imbued with a sense of tradition, and no team more so than the New York Yankees, disdainful of innovations like placing players’ names on the backs of their jerseys and resistant to eroding strict standards related to haircuts and beards.

It’s why doctors and patients alike should pay special attention to why the Yankees parted ways with their old manager and what they now seek instead. In a word: “collaboration.”

That’s the takeaway from a recent New York Times article examining why the Yankees declined to re-sign manager Joe Girardi despite his stellar “outcomes” (to use a medical term); i.e., the best record in baseball during his 10 years at the Yankees’ helm. But Yankees executives believe the game has changed. The model for future success is the Los Angeles Dodgers, the tradition- and cash-rich franchise on the opposite coast that went to this year’s World Series while the Yankees sat home.

The new way to win? According to Dodgers executives, it requires a combination of statistical analysis, shared decisions and communication between and among all stakeholders based on collaborative relationships.

Why Hospitals Are Losing Serious Money And What That Means For Your Future

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A strange thing happened last year in some the nation’s most established hospitals and health systems. Hundreds of millions of dollars in income suddenly disappeared.

This article examines the economic struggles of inpatient facilities, the even harsher realities in front of them, and why hospitals are likely to aggravate, not address, healthcare’s rising cost issues.

According to the Harvard Business Review, several big-name hospitals reported significant declines and, in some cases, net losses to their FY 2016 operating margins. Among them, Partners HealthCare, New England’s largest hospital network, lost $108 million; the Cleveland Clinic witnessed a 71% decline in operating income; and MD Anderson, the nation’s largest cancer center, dropped $266 million.

How did some of the biggest brands in care delivery lose this much money? The problem isn’t declining revenue. Since 2009, hospitals have accounted for half of the $240 billion spending increase among private U.S. insurers. It’s not that increased competition is driving price wars, either. On the contrary, 1,412 hospitals have merged since 1998, primarily to increase their clout with insurers and raise prices. Nor is it a consequence of people needing less medical care. The prevalence chronic illness continues to escalate, accounting for 75% of U.S. healthcare costs, according to the CDC.