THCB

The Dangerous Patient Safety Delusions of Eminence-Based Medicine

The eminent physicians Martin Samuels and Nortin Hadler have piled onto the patient safety movement, wielding a deft verbal knife along with a questionable command of the facts.

They are the defenders of the “nobility” of medicine against the algorithm-driven “fellow travelers” of the safety movement. On the one side, apparatchiks; on the other, Captain America.

They are the fierce guardians of physician autonomy, albeit mostly against imaginary initiatives to turn doctors into automatons. By sounding a shrill alarm about straw men, however, they duck any need to define appropriate physician accountability.

Finally, as befits nobility, they condescend to their inferiors. How else to explain the tone of their response to the former chief executive officer of Beth Israel Deaconess Medical Center, Paul Levy? As for patients, Samuels and Hadler defend our “humanity.” How…noble.

To me, healing the sick is an act of holiness, not noblesse oblige. Fortunately, we Jews cherish a long tradition of arguing even with God Himself. A famous Talmudic story ends with God acknowledging that even Divine opinion isn’t enough to override the rule of law. Let’s take a closer look at Samuels’s and Hadler’s opinions in relation to the rules of medical evidence.

Samuels, a neurologist, began this controversy with a post that segues from erudite musings about memes into a jeremiad against the danger of believing medical error constitutes a big danger. He writes:

“The current medical culture is obsessed with perfect replication and avoidance of error. This stemmed from the 1999 alarmist report of the National Academy of Medicine [formerly the Institute of Medicine], entitled “To Err is Human,” in which the absurd conclusion was propagated that more patients died from medical errors than from breast cancer, heart disease and stroke combined; now updated by The National Academy of Medicine’s (formerly the IOM) new white paper on the epidemic of diagnostic error.”

The evidence for a cabal of obsessives pushing an “absurd” perfectionist agenda is meager, as some commenters pointed out. This pushback perturbed Hadler, who jumped in to support his “renowned” colleague by agreeing that the 1999 report, which concluded that preventable medical errors in hospitals kills from 44,000 to 98,000 Americans annually, only “purported to expose an alarming frequency of fatal iatrogenic error.” Hadler then added a comment that immediately rang a bell. Here’s Hadler:

Dr. Samuels reads the Report as a documentation of the price we pay for imperfect knowledge.

And here’s Dr. David Barr, in a JAMA article noting that errors may be regarded as the price that we, as responsible physicians, must pay for the inestimable benefits of modern diagnosis and therapy.

That article , entitled, “Hazards of Modern Diagnosis and Therapy­–The Price We Pay,” appeared in 1955. Like Dr. Barr, Drs. Samuels and Hadler seem confused about who, exactly, is paying what price. More broadly, their assertions exhibit little familiarity with the patient safety literature that has appeared throughout their own careers.

A couple of quick examples: back in the 1970s, when Samuels and Hadler were both brilliant young physicians, the first multi-hospital study of medical error was published by Don Harper Mills. Mills, a physician and attorney investigating soaring malpractice costs, comfortingly concluded that few “potentially compensable events” resulted in lawsuits.

However, Mills’s tally of the actual death toll ran into the thousands even when he deducted deaths of patients who seemed likely to have died soon, anyway – as Hadler does in his blog post. Nonetheless, when you extrapolated Mills’s findings from California to the nation, as I did, the total was about 121,000 premature deaths every year from medical care in hospitals alone.

But Mills in 1978, like Barr in 1955, cautioned that “no one should remain unaware that benefits and adverse risks [of modern medicine] are inseparable.” As Samuels and Hadler apparently wish were still true, the medical culture back then took those deaths in stride and did not become “obsessed” with error. In 2015, Samuels seems equally fatalistic about patient fatalities as his professional forbears were many decades ago. He writes: “Focusing on the evil of errors takes our attention away from the real enemy, which is illness.”

Translation: “We doctors are trying to cure people here, so you alarmists have to expect some unavoidable collateral damage.”

(A personal note: As an adjunct academic, I’ve contributed to, peer-reviewed and read the literature on patient safety for 20 years and written about it from its earliest roots.)

Samuels, by the way, offers no evidence to justify his dismissal of the 1999 report. He also swipes at the IOM report on diagnostic error released earlier this year, but in doing so he fails to distinguish between errors of execution (the earlier report) and errors of intent (2015). Samuels might have offered constructive insights from a master clinician about diagnostic precision. Instead, he indulges in captious kvetching about some presumed push for industrial-scale perfection.

Hadler appears to have read more of the literature. That doesn’t mean, though, he’s willing to conduct a serious discussion. Instead, he declares:

“Most of the fatal errors that led to the horrifying statistics that elicit national outrage were judgment calls, defined as errors either by peers reviewing medical records or by virtue of the voluntary reporting of errors by doctors and hospitals.”

To begin with, since voluntary reporting has largely failed, it would result in under-reporting the statistics, not magnifying them. More important is Hadler’s reference to “judgment calls.” This seems to be a put-down of the Harvard Medical Practice Study, whose findings were a major part of the 1999 IOM report.

By way of context, that study’s inter-rater reliability was deemed sufficiently reliable for publication in the New England Journal of Medicine. Perhaps the only Harvard doctor Hadler trusts is Samuels?

There’s another study from the New England Journal that may have hit Hadler closer to home. A team of researchers examined error-reduction efforts in North Carolina, where Hadler is based, in the wake of the “To Err is Human” report.

They concluded: “Harm to patients resulting from medical care was common in North Carolina, and the rate of harm did not appear to decrease significantly during a 6-year period.”

The researchers prescribed a need “to translate effective safety interventions into routine practice.” Hadler, based on his blog post, likely would have responded that “the preventability of hospital deaths due to medical errors was very much ‘in the eye of the reviewer.’”

You get the point. Samuels and Hadler are correct in their comfortable complacency, while the New England Journal, JAMA, BMJ and a host of other journals have been duped by the “alarmists.”

A last point: the perils of disrespect.

The reliability of the IOM numbers and the Office of Inspector General methodology have been questioned, examined and debated in the scholarly literature a long time ago. More recent studies done by the Agency for Healthcare Research and Quality have updated data. Samuels and Hadler address none of this.

Everyone who seriously studies patient safety would agree that an estimate of at least 100,000 preventable deaths from preventable medical errors in hospitals is conservative. That conclusion is supported by a raft of studies with different methodologies at different times. Slogans like “pursuing perfection” are aspirational, presumably reflecting the ethical ideals which Samuels and Hadler purport to uphold, rather than a grim requirement of an industrial improvement czar come to stamp out humanism and human variability.

The mens’ legitimate concerns about overreaching by data enthusiasts are washed out by their wackiness about patient safety. In this regard, Samuels and Hadler are the guy pointing to sub-zero temperatures in January as conclusive evidence of the “absurdity” of global warming. They are Ben Carson, boasting that his success as a brain surgeon makes him an authority on the moral capability of Muslims to serve as president.

A response to Samuels and Hadler in this space might have come from physicians like Bates, Berwick, Blumenthal and Leape from Harvard; Makary and Pronovost from Johns Hopkins; Krumholz from Yale; or Wachter from University of California-San Francisco. Like Samuels and Hadler, they are accomplished clinicians and gifted writers on the faculty of prestigious institutions. Peers, not peasants.

But these patient safety research pioneers know, as I do, that neither evidence nor eloquence will change closed minds. Moreover, in the hierarchical world of academic medicine, Samuels and Hadler are Very Big Names. I suspect they have no desire to refight old battles with powerful colleagues.

Me? I’ve been contributing to this blog since it was first established, so I couldn’t just pick up my coffee cup and go elsewhere. In my 2003 article for Health Affairs, “The Silence,” I quoted Eli Wiesel. I invite Samuels and Hadler to read that article and “Why We Still Kill Patients” and “Still Demanding Medical Excellence.” While you’re at it, take 20 minutes to watch “The Bizarre Business Case for Patient Safety.”

I have nothing but respect for the many and varied accomplishments of Samuels and Hadler. Unfortunately, their ill-informed dismissal of the magnitude of preventable patient deaths and of the systematic efforts to prevent them represents a self-inflicted stain on the holiness of all the past good works they have done.

Michael Millenson is a patient safety advocate and the president of Health Quality advisors

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lawyerdoctorWilliam Palmer MDLeahBindercharliekenney@gmail.comMillenson Recent comment authors
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lawyerdoctor
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lawyerdoctor

One of the primary differences between doctors and lawyers is the way in which we disagree. Attorney X opposes Attorney Y, they argue all day in court, “zealously representing” their clients, in a civil but aggressive fashion. Then they go out and play golf together, and have a few drinks. Doctor A and Dr. B disagree on the best treatment for pneumonia. Dr. A says every patient should get rocephin plus Zithromax, Dr. B says Levaquin is treatment of choice. Dr. A thereby thinks Dr. B is an idiot. Dr. B refuses to speak to Dr. A. That’s because Doctors… Read more »

Millenson
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Millenson

Thanks to all for the feedback. Dr. Palmer, I have heard it said that every physician has 3 patients: his parent, his spouse and his child.

William Palmer MD
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William Palmer MD

Wouldn’t the safest hospital be the one where every worker and professional thought that the patient he cared-for was his mother?

A way to mimic this might be to have all claim money go through the patient first. Like the old indemnity system, And the patient can pay provider claimants their charge or whatever he feels they were worth.

LeahBinder
Member

This is a terrific post, Michael. The reason the numbers are wildly imprecise in estimating deaths from errors is that safety problems don’t readily appear in administrative data. Providers don’t bill for the cost of treating an infection, they bill for the individual services associated with it. So the fact we have to estimate lives lost is a symptom of the overall problem in health care that everything, including data collection, tends to pivot around the priorities of physicians, not the experience of patients.

charliekenney@gmail.com
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charliekenney@gmail.com

Vy interesting, thoughtful piece, thank you. One additional thought re To Err Is Human. I think it can reasonably be argued that the report was an awakening for many health care professionals re the nature and breadth of preventable errors. The full extent and impact of this awakening may not be measurable but it is real.

@RogueRad
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Admittedly, I have not had much experience arguing with God. We Hindus have so many that it’s easier to bribe them, than argue with them. I do have an incurable habit of arguing with methodology. I blame my partial knowledge of statistics. The thing that strikes me with the research about patient errors is the estimate of deaths caused by errors – 44,000, no 98, 000, no 440, 000, no 4.4 million. There seems to be a power law operating, like a Richter scale. I have no idea why this is. But it strikes me as odd. I’m aware of… Read more »

Millenson
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Millenson

RogueRad: Without getting too much into methodology, estimates from HealthGrades, Hearst investigative journalists and AHRQ end up around 100,000, plus or minus, while some other methodologies publishes in the medical literature using the trigger tool (and other work by Dr. Brent James) go up to 400,000. The IOM report from 1999 had the broad range it did because it was based on two or three studies, if memory serves.

Much has been done since 1999, though some people obviously believe none of it.

I, am of course, flattered to be mentioned in the same breath as Dr. Ben Carson.