Dr. Kaveh Shojania, a prominent patient safety expert who scoffs at the numbers and laughs at the tragedy inflicted on countless victims of medical error, should step down as editor of a leading hospital safety journal.

About three years ago, a scientist named John James published a study proclaiming that — at minimum — 210,000 people die every year from hospital errors, making it the third leading cause of death in this country. At the high-end, “the true number of premature deaths associated with preventable harm to patients was estimated at more than 400,000 per year,” James wrote. “Serious harm seems to be 10 to 20-fold more common than lethal harm.”

Even though James was on solid ground as a meticulous statistician, publishing these figures was a pretty bold act.

The medical establishment had been posting a casualty rate of about 98,000 unnecessary hospital deaths a year since the Institute of Medicine (IOM) came up with that figure in 1999. The IOM report caused a big media stir at the time. There was finger-pointing and soul-searching. There were conferences galore. Commissions and committees and foundations sprang up.

The medical community’s defensive interpretation of the findings is reflected in a handbook for nurses written in 2008:

What was often lost in the media attention … was the original intent of the IOM [which] believed it could not address the overall quality of care without first addressing a key, but almost unrecognized component of quality; which was patient safety.

Not killing people by accident in the hospital is a “component of quality.” Patient safety is a concept. Media attention is bad. There is also an assertion that people aren’t harmed by lack of competence or good intentions; that when someone is hurt or killed in the hospital, it’s not the fault of anyone who works there.

Who, then, is to blame? The system.

It’s all about systems and processes. Patient safety is “a property of a system of care,” a system in which “imposing reporting requirements and holding people or organizations accountable do not, by themselves, make systems safer.”

Reporting, accountability, and responsibility are overrated. It is this conservative, institutional posture that has given rise to increasingly vocal grassroots patient safety activism, people who get involved because they have been maimed, crippled, disfigured, or have lost husbands or wives or children to negligence or error. This depersonalization of a very real problem into abstract concepts of systems analysis just doesn’t cut it for these people, and they are tired of endless bureaucratic bromides that flow from the permanent patient safety industry spawned and sustained by corporate medicine itself.

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John James, an activist whose son died due to a series of hospital mistakes in 2002, might as well have nailed his paper to the door of the National Institutes of Health — except for one thing: he didn’t have Martin Luther’s name recognition.

But in the world of patient safety, Dr. Marty Makary at Johns Hopkins does. He is one of the many high-profile medical professionals who have seen the currency in patient safety, and has run with it. They like to think of themselves as renegades within the system, working for change from the inside. They write books and come up with checklists and manifestos and shocking revelations which, in the end, don’t really change much.

But these people are very good at marketing.

Makary took John James’ work and spun it into a new piece for BMJ, asserting that more than 250,000 people die every year from medical mistakes. While the establishment could live with James’s devastating assessment lurking beneath the public consciousness, Makary’s showboating had broken through and was attracting the kind of unwanted public attention the IOM report generated 17 years ago.

So, naturally, the establishment had to strike back.

Makary’s sloppy interpretations of James’ work made for an easy target. Described by one expert as a “statistical abomination and affront to logic,” the paper has been denounced in journals, and critics have called for the paper to be retracted. Basically, what Makary did was put a new spin on John James’ work, using a strikingly similar table as James’, but leaving out a pilot study which James considered essential. In addition, Makary’s method of averaging previous studies lacks a third grader’s understanding of what averaging means.

This gave ammunition to the institutional patient safety careerists who are loath to admit that a) anything is seriously wrong, and that b) the problem has actually gotten worse since the IOM report came out — thereby confirming their irrelevance.

Among the chief establishment scoffers is Dr. Kaveh Shojania, editor-in-chief, BMJ Quality & Safety, keynote speaker at the recent National Patient Safety Foundation’s annual gathering.

“I can’t be clear enough about this,” Shojania said. “I have no idea how this got published. They claim that medical error is the third leading cause of death. I’m not sure why 16 years into a successful movement they thought they needed to ratchet it up from eighth to third.” Shojania conflated Makary’s paper with John James’ work, alluding to a Consumers Union public awareness campaign employing the metaphor of two jumbo jets crashing every day to put annual hospital casualties in perspective.

“I think it was originally three jumbo jets crashing every two days,” he said, shaking his head and chuckling. “That was too much of mouthful, and even one every day and a half was too much, so I think most just said it was a jumbo jet every day.”

The room full of patient safety experts laughed.

Shojania had his own paper published in BMJ, claiming only 25,000 inadvertent hospitals deaths annually. Of course, he wouldn’t count those people who were old and sick, or just very sick, because they would have died anyway.

“We need,” Shojania said, to be “reining ourselves in when we are tempted to just grab people’s attention. We need to be a little more careful about the messages we send. I think we may have to be happy with just one Jumbo jet a day and no more than that, and stop saying it is the third leading cause of death.”

It’s all so silly. Nothing to see here, folks.

By all accounts, BMJ should retract Makary’s paper. But by the same token, BMJ Quality and Safety should replace Kaveh Shojania with a true patient safety expert, one who doesn’t disrespect the victims of medical error and belittle their plight.

Dan Walter is a patient safety advocate and author of Collateral Damage: A Patient, a New Procedure, and the Learning Curve.

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