Could a Personal Letter Start a Medical Revolution?

Oct. 4, 2016
Could Dr. Martin Makary’s letter to Dr. Thomas Frieden, CDC director, asking for a change in how deaths are recorded, change how the U.S. healthcare system approaches medical errors in hospital care?

There are letters—and then there are letters. And this one, dated Sunday, May 1, and written by Martin Makary, M.D., M.P.H., and addressed to Thomas Frieden, M.D., director of the federal Centers for Disease Control and Prevention (CDC) is absolutely exceptional.

Here’s what it’s about: Dr. Makary, a professor of surgery and health policy & management at Johns Hopkins University in Baltimore, and his co-author, research assistant Michael Daniel, have just published a very important study, published Tuesday in The BMJ (formerly the British Medical Journal. An online report from National Public Radio (NPR) has summarized it very well. NPR’s online report, by Marshall Allen and Olga Pierce, explains that “A study by researchers at Johns Hopkins Medicine says medical errors should rank as the third-leading cause of death in the United States — and highlights how shortcomings in tracking vital statistics may hinder research and keep the problem out of the public eye. The authors, led by Johns Hopkins surgeon Dr. Martin Makary, call for changes in death certificates to better tabulate fatal lapses in care. In an open letter, they urge the Centers for Disease Control and Prevention to immediately add medical errors to its annual list reporting the top causes of death.”

Allen and Pierce note that, “Based on an analysis of prior research, the Johns Hopkins study estimates that more than 250,000 Americans die each year from medical errors. On the CDC's official list, that would rank just behind heart disease and cancer, which each took about 600,000 lives in 2014, and in front of respiratory disease, which caused about 150,000 deaths. Medical mistakes that can lead to death range from surgical complications that go unrecognized to mix-ups with the doses or types of medications patients receive,” they add. But the problem is that no one knows exactly how many deaths are really caused by medical errors, in part because the coding system used by the CDC to record death certificate data “doesn't capture things like communication breakdowns, diagnostic errors and poor judgment that cost lives,” the NPR story notes.

Indeed, in The BMJ article itself, Dr. Makary and his co-author, research assistant Michael Daniel, note the following:

“The most commonly cited estimate of annual deaths from medical error in the US—a 1999 Institute of Medicine (IOM) report7—is limited and outdated. The report describes an incidence of 44 000-98 000 deaths annually.7 This conclusion was not based on primary research conducted by the institute but on the 1984 Harvard Medical Practice Study and the 1992 Utah and Colorado Study. But as early as 1993, Leape, a chief investigator in the 1984 Harvard study, published an article arguing that the study’s estimate was too low, contending that 78% rather than 51% of the 180 000 iatrogenic deaths were preventable (some argue that all iatrogenic deaths are preventable).10 This higher incidence (about 140,400 deaths due to error) has been supported by subsequent studies which suggest that the 1999 IOM report underestimates the magnitude of the problem. A 2004 report of inpatient deaths associated with the Agency for Healthcare Quality and Research Patient Safety Indicators in the Medicare population estimated that 575,000 deaths were caused by medical error between 2000 and 2002, which is about 195,000 deaths a year. Similarly, the US Department of Health and Human Services Office of the Inspector General examining the health records of hospital inpatients in 2008, reported 180,000 deaths due to medical error a year among Medicare beneficiaries alone. Using similar methods, Classen et al described a rate of 1.13 percent. If this rate is applied to all registered US hospital admissions in 2013, it translates to over 400,000 deaths a year, more than four times the IOM estimate.”

Yes, that’s right—Dr. Makary and Michael Daniel, based on their research, are stating that in 2013, the U.S. experienced over 400,000 deaths a year. In other words, medical errors that occur in hospitals are the third-highest cause of death in the U.S., behind only heart disease and cancer, and ahead of respiratory disease. That is an astonishing statistic.

And thus, Dr. Makary’s letter to Dr. Frieden, which begins thus: “Dear Dr. Frieden, We are writing this letter to respectfully ask the Centers for Disease Control and Prevention (CDC) to change the way it collects our country’s national vital health statistics each year. The list of most common causes of death published is very important-it informs our country’s research and public health priorities each year. The current methodology used to generate the list as what we believe to be a serious limitation,” Dr. Makary states. “As a result, the list has neglected to identify the third leading cause of death in the U.S.—medical error.”

As Dr. Makary points out, “Currently, the CDC uses a deaths collection system that only tallies causes of death occurring from disease, morbid conditions, and injuries.” Instead, he writes, “We suggest that the CDC allow clinicians to list medical error as the cause of death, and in the interim, the CDC should list medical error as the third most common cause of death in the U.S. after heart disease (611,106 deaths per year) and cancer (584,881 deaths per year) and replacing respiratory disease (149,205 deaths per year).”

He goes on to state that “Appropriately recognizing the role of medical error in health care has enormous implications for medicine. Drawing on reliable data, deaths from care, rather than from the disease that brought the person into care, should be addressed with the same resources and vigor as other scientific endeavors. At minimum, listing the death burden of medical error would help create an open dialog about the problem. Currently, deaths due to medical error result only in internal discussions in confidential forums such as a hospital’s internal root cause analysis committee or a department’s morbidity and mortality conference.”

So—wow. Yes. Imagine if Dr. Frieden were to take Dr. Makary up on his suggestion and change the IDC coding system to allow medical error to be listed as the cause of death. It is hard to imagine that that change would not cause a revolution in public awareness around medical errors, and would not force clinicians and patient care organizations into a new era of transparency and accountability.

Now, what are the chances that the CDC would try to force a change in this area? It’s very hard to say. At the moment, they are probably not significant. But things are changing fast, and healthcare consumers are becoming more and more aware by the day. What’s more, healthcare policy leaders, including federal legislators and senior officials in federal agencies, are shifting, too.

Only time will tell; but not since 1999, when the Institute of Medicine’s ground-shifting report, and book, To Err Is Human: Building a Safer Health System, came out, with its estimate of 98,000 medical error-caused deaths a year, has a number been embedded with so much potential significance.

So we’ll see what, if anything comes of this BMJ article and this letter. But I have to say, this letter was and is quite exceptional—and has the potential to be a game-changer, depending on what happens next.

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