American Patient Safety Crusade Politics

On May 3, 2016, the BMJ (formerly the British Medical Journal) renewed a patient safety and medical negligence scaremongering campaign by publishing an article authored by cancer surgeon Martin Makary, M.D. and Michael Daniel, a research fellow, both faculty of the Johns Hopkins School of Medicine.  In the article, the authors claim that 250,000 Americans die in hospitals every year due to neglectful and incompetent treatment by nurses and physicians.  Dr. Makary has, as an avocation, patient safety research and advocacy.

The title of the Makary article in the BMJ created a splash and coverage by the general media with widespread publicity, as intended.  For example, "Medical error – the third leading cause of death in the US."  However, it is our assertion that the authors' claim plays to publication bias and the propaganda of a patient safety crusade that repeatedly exaggerates and invents a scare about hospital care negligence.  Behind this is a crusade that promotes government control of health care.

Makary and Daniel wrote a ridiculously short and superficial essay for a major journal like the BMJ; put up their claim of negligence deaths, cobbling together references from studies that were 8-16 years old; and performed no original research here.

Dr. Makary has done this before, and this estimate of 250,000 annual in hospital deaths is a repeat of previous claims he has made.  It should be pointed out that this 250,000 number is not an accounting of deaths, but an extrapolation from the four studies that had fewer than 20 actual patient deaths where medical error "may have" contributed.  No journal with a serious peer review process would accept this paper.

Makary builds his case with the benefit of previous seminal and lauded, but flawed, studies on patient safety.  Two were done by a Harvard research group headed by Troyen Brennan, M.D., J.D., MPH in New York Hospitals in 1984, published in 1991.  The other was of Utah and Colorado hospitals from 1992, published in 2000.  The two Harvard studies, which had some serious methodological problems, were the foundation for an equally uncertain and unreliable monograph by the Institute of Medicine (IOM, subdivision of the National Academies of Science).  That paper had an early release online in 1999 with no peer review or public comment, and then a hard copy monograph in 2000, "To Err is Human."

The Makary and Daniel article in the BMJ cited cherry-picked information from these four studies to inflate claims of negligence deaths with gusto.  The studies cited are poisoned by methods and definitions that permeate the patient safety research and exaggerate the numbers, by various methods and for political reasons.  For example, the old and more rigid concept of medical negligence has been expanded by patient safety researchers to a broader, expansive concept of "preventable" so that the number of in-hospital deaths alleged to be due to poor medical care is amplified.  Their definition of medical error – which includes correct treatment that is unsuccessful – is so expansive as to be meaningless.

The claims of Makary and Daniel have reached the risible and easily rejected level of neglectful care deaths of 250,000 annual, one third of all hospital deaths in America annually, 0.7% (corrected) of the 31 to 34 million annual hospitalizations in the U.S.

This new paper by Makary and Daniel is superficial yellow journalism and very much like the Wall Street Journal essay the former wrote in September of 2012, "How to Stop Hospitals from Killing Us."  Dr. Makary was, and is, an irresponsible scaremonger.

The serious studies of patient safety, in spite of methodological problems that exaggerate negligence findings, still find a pattern of negligence with injury only of much less than 1%.  That's in spite of a strong tendency in these studies to find fault when the patient dies – that's called outcome bias.  This is striking, given that the studies were done by patient safety researchers who have a huge inherent bias – the need for large negligence death numbers to get published and for them to be heralded as rescuers and saviors.

The rate of negligent and preventable deaths claimed by Makary and Daniel, using their selected references, is much greater than reported by the previous major patient safety studies of care in 1974, California; 1984, New York; and 2001, Utah and Colorado.  Such a preposterous claim is the product of projections from data dredging small studies, selected by Makary and energized by researcher bias and ambition.  After all, what will a patient safety expert do if there is no patient safety crisis?

Underlying the potential for bias and exaggeration in these studies is a political agenda created by an elite chattering class that wants to control the vast business that is the health care system.  First knock it down and make people think it needs fixing and regulation, then propose government intervention and regulations – the strategy of all leftist good-intentions projects.

The Obamacare fiasco is partially a product of two things: the perceived need to fix the insurance system that was screwed up by excess government regulation and the desire to bring those evil and incompetent hospitals, physicians, and nurses under control.  The patient safety crusade of the last 30 years was a key to breaking down public confidence and raising the cry that the healthcare system must be fixed.  No one asked if it would be a good idea if the company that gave us the VA and the Post Office should be in charge of such a fix.

Patient safety studies are done by people who want to show negligence and danger, as Mencken succinctly said – so the populace will be clamorous to be led to safety.  This is the goal of practical politics through history.  Patient safety projects and the crusade are jobs program enhancers for wannabe mavens of patient safety in academia and in government agency work.

This paper by Makary and Daniel is another effort to buff up the patient safety expert image and their role as advisers and consultants in safety.  Of course, the consumer advocates, politicians, and the plaintiff attorneys will cheer that someone has pointed a finger and suggested a crisis along with new ideas for solutions.

In April of 2000, five months after "To Err is Human" announced the patient safety crisis and an epidemic of medical errors, Troyen Brennan, M.D., J.D., a lead Harvard researcher on the studies that were the backbone of the IOM report and the source of the negligence death numbers that scared so many, asserted in an essay in the New England Journal of Medicine that the research of the Harvard group was weak and was being misused by the IOM.

Brennan wrote:

- "I have cautioned against drawing conclusions about the numbers of deaths in these studies."

- "The ability of identifying errors is methodologically suspect."

- "In both studies [New York and Utah/Colorado] We agreed among ourselves about whether events should be classified as preventable[.] ... [T]hese decisions do not necessarily reflect the views of the average physician, and certainly don't mean that all preventable adverse events were blunders."

Imagine a prominent Harvard physician and faculty member warning the public about the inadequacies of the Harvard safety studies that he had led and that had been used by the IOM as the backbone of a national patient safety campaign.

Makary and Daniel would have the public and the health care community believe that 250,000 of the 700,000 in-hospital patients who die every year in America were killed by their medical care.  They also play the game of "we won't blame anyone – it's a systems problem we geniuses can fix."

A ginned up patient safety problem is perfect for confident patient safety experts.  However, the crisis is the product of bad research motivated by ambition and excess confidence.  Deaths by doctors and nurses are the problem?

Researchers in patient safety have created a crisis with big numbers by changing definitions, massaging the research, expanding the concept of "negligence" to include all sorts of "preventable" events, and projecting small, tortured research results to big national numbers that appear to represent a crisis in negligent care.  If you study the less than 20 deaths as the Makary Daniel referenced studies do, and dredge up a high rate of deaths by doctor or nurse, you can project to the 700,000 in hospital deaths a large number. Then you can get a headline in the BMJ on line.  Junk science success.

Every health care provider, at any level, trains and educates and drills to provide appropriate care and then acts in accordance with that training.  Mendacious patient safety doyens, encouraged by politicians and consumer grievance advocates, as well as plaintiff attorneys, try to take the stage.  They claim that great harm befalls anyone who seeks medical care, and people are dying from medical care – and that is a construct that is quite convenient to those who would be the caudillos of the patient safety movement.

The Makary-Daniel paper does nothing to advance safety of medical care.  Rather, it would advance the agendas of those who would tear down the system.  We need to care about the survival of the best medical care system on the planet.

Longer and more detailed discussions of the patient safety studies and the politics of the patient safety movement since the late 1980s are here and here.

John Dale Dunn, M.D., J.D. is an instructor in emergency medicine at Fort Hood, Texas.  His opinions should not be attributed to the U.S. Army or the Department of Defense.  Gerard J. Gianoli, M.D. is a physician at the Ear and Balance Institute in Covington, Louisiana and is a clinical associate professor at Tulane University School of Medicine.