Abstract
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The paper stimulated polarized responses. Those in the medical mainstream tended to react with defensiveness, attacking the report's assumptions and merits. 2 Those associated with alternative and integrative healthcare models reacted as quickly, though with different conclusions: aren't these deaths proof that significant shifts in the U.S. medical industry are long overdue? 3
I played my part in this polarizing dialogue through two articles at The Huffington Post. I was familiar with the series of stories on medical errors dating back to the 1999 To Err is Human that kicked off the safety movement. A quality director for a multi-state medical delivery organization, Catholic Health Initiatives, had written a piece in 2006 that included his reference to data that placed error in that startling position among causes of death. 4 My discomfort with those data is part of my motivation to change medical delivery. So, I readily accepted Makary's conclusion and wrote a piece called “In Defense of ‘Alternative Medicine.’” 5 Curiosity about why the analysis was published out of the United States led to a query to Makary. My second piece was stimulated by his blunt e-mail response: “NEJM said not relevant to practicing docs. JAMA said pass. So we went to next highest impact journal [in] medicine.” 6
Some colleagues, on reading critiques of the analysis from the Hopkins team, urged me to take another and perhaps more balanced look at the paper, and the subsequent controversy. With this column, I report my reflections. My accent is ultimately on practical questions: what contributions from integrative health approaches and practices might diminish the likelihood of such errors that do occur, and what are the implications for the research community?
Production Orientation, Reductive Approach, Poor Evidence Base: A Perfect Storm?
The most significant critique of Makary's work is that it hit as original research when in fact the team was only arriving at an estimate based on prior studies. This is, in strict terms, a reasonable challenge, supporting the “pass” decisions for the U.S. journals. Yet, given the enormity of the issues—even if all the assumptions throw the data off by two-thirds—is this not an important area to which to return our attention, especially given the apparent intractability of the problems?
My reflections led me down the following path. Consider these three characteristics of U.S. medicine. The first is that the vast majority of medical delivery continues to be organized around industrial principles rather than healthcare values. Otherwise, why is there a movement for value-based medicine? 7 The dominant drivers remain production of services and generation of income over expense. We live in a context that is perversely incentivized against health. 8 Success comes from doing more. Organization of office visits favors shorter visits in which practitioners are paid more per minute. Business management focuses on the place of greatest margin—tertiary care—rather than the place of health, out in communities. Tertiary care is the principal setting for the thousands of family dramas rolled into the Hopkins team's estimate of 251,000 medical deaths.
The second characteristic of U.S. medicine is that only a fraction of what is done has quality evidence to support it. Estimates vary. One blunt assessment was recently offered by Steven D. Shapiro, MD, chief medical and scientific officer for the University of Pittsburgh Medical Center: “Only a quarter of what we do has strong evidence and we only do that half the time.” 9 With this uncertainty, clear tracks on which the engines of production can run are impossible to lay. So the industry is incentivized to do more even though the direction is murky.
The third characteristic is a reductive biomedical orientation that favors suppression. The industry prefers simplistic assessment—though often via complex methods—and prescription of single agents. Much of what the whole system of the presenting human life might teach is poorly examined and addressed. The portrait of medical delivery that is emerging is of a hyped up adolescent: fast-paced activity amid significant ambiguity, guided via compromised vision. Is this not a perfect storm for running a car into a telephone pole?
The Issue Is Not Errors—It's the Context
The authors' definition of an “error” denies the evidence ambiguity. Here is the broad net that Makary and Daniel cast: an unintended act (either of commission or omission); an act that does not achieve its intended outcome; the failure of a planned action to be completed (an error of execution); the use of a wrong plan to achieve an aim (an error of planning); or deviation from the process of care.
Consider the second category. If the first half of the University of Pittsburgh medical director's statement on evidence is correct, achieving “intended outcomes” is likely to be quite uncertain, in the best of conditions, roughly three-quarters of the time. Then throw in the additional fraction from the 50% who are not taking the 25% of clinical pathways that are engineered with quality data. The accent should definitely be on “intended” rather than “anticipated” outcomes. Evidence ambiguity raises additional red flags in the fourth category. Whether a physician has set a “wrong plan to achieve an aim” is a judgment call if there is poor evidence for a right plan.
I learned this in a throat-cancer experience in 2009. Three radiation oncologists and four medical oncologists who my spouse and I interviewed yielded five separate courses of action. If I hadn't survived, would some reviewer call it a wrong plan? And might evidentiary uncertainty that necessarily surrounds the “planned action” be likely to foster a tendency toward “deviation” and a “failure to complete” on a set course?
“Error” suggests a backdrop of clarity on what is right. Yet, this is not what prevails. Understood in this way, the mortality in the authors' sights is linked to something bigger than errors. Rather, the issue is the context of industrial overproduction of services in which we know already that at least 30% considered unnecessary and waste. 10 The foundational strategy for limiting medical deaths is less to reduce the problem to one of errors. What is needed is a focus on shifting the incentive structure and the approach in the core operation. Replace the production driver and reductive models with value-based, whole person decision making.
The best in U.S. medicine are moving in these directions. At the Institute for Healthcare Improvement, this has been captured as the Triple Aim: bettering patient experience, enhancing population health, and lowering per capita costs. 11 The more recent “Quadruple Aim” construct adds enhancing practitioner experience to the values. 12 Evidence of cost savings and positive human outcomes are prioritized over biomedical markers and production of services.
Opportunities Amid Alignment with the Value-Based Transformation
The emerging cluster of value-based aims makes clear that solving the harm-prone medical industry—at whatever level of medical death—requires a whole-system response. Not surprisingly, those who are bringing multiple approaches that are called traditional or complementary or alternative or integrative report significant alignment with the emerging movement. A survey that I reported on behalf of colleagues Jennifer Olejownik, PhD, Melinda Ring, MD, and Jeffrey Dusek, PhD, in an oral poster session at the May 2016 International Congress on Integrative Medicine and Health found that 90% find alignment with the Triple Aim values, with 43% marking “strongly” so. 13,14 Many respondents—leaders of medical delivery organization-based integrative centers—shared that specialists in their sponsoring medical systems were showing greater interest in potential roles for integrative medicine approaches as a focus on values began to poke through the cement of the freeway of production of procedures and of revenue. Notably, however, only a minority of the integrative center leaders who were surveyed believed that they had a thorough understanding of the emerging context.
This whole-system solution to medical errors suggests many roles for traditional, alternative, complementary, and integrative approaches and practices. First, better use of these new therapies and provider types expands the tools and strategies for keeping the locus of care out in communities instead of in the problematic hospital environment. One of the commentators at Medscape for instance pointed out that when it comes to “errors” that lead to death, the most significant culprits are the errors individuals make in living the standard U.S. life-style. 2 A starting place in limiting medical deaths is for us to take better care of ourselves. We'll be less likely to need treatment or to be admitted if we do. The across-the-board engagement by multiple integrative and traditional medicine practitioners with life-style medicine, there are clearly important roles for integrative and traditional practices and practitioners.
Match the Values Focus in Study Designs and Selections of Outcomes
More evidence that integrative practice keeps people healthy and out of hospitals would be useful. Our research needs to capture these life-changing outcomes better. The values movement is toward primary care and community medicine. Outpatient care offers a home-field advantage for traditional medical systems and licensed integrative health practitioners, from yoga and massage therapists to acupuncture and Oriental medicine specialists and integrative, chiropractic, and naturopathic doctors. And when people are admitted to hospitals, broader integrative teams need to be available to catch, hold, and treat the whole person and help keep them from being biomedically reduced. Such efforts would be served by research data that measure quadruple-aim outcomes. Think patient experience, enhancing life-style skills, faster healing times, diminished hospital stays, and more pleasure of practitioners in their caregiving. Some have begun gathering these outcomes. We need bushels more. We'll also have a growing need for reports that delineate processes and obstacles overcome in highly functioning integrative care teams.
The whole-system response to medical deaths is opening minds and doors to integrative practices and to leadership from the integrative community. In one remarkable example, the state of Oregon is seeking to reduce the morbidity and mortality associated with opioids through prioritizing the care of chiropractors, acupuncturists, and massage and yoga therapists. 15 To maximize our effectiveness as agents of change in helping create health in those we serve, more of us need to study up on the emerging language, goals, and methods of the value-based movement, then match up to these aims in our study designs and selections of outcomes. Advancing whole-person care and linking to the emerging values appear to be our best opportunities to help shape the path away from death and toward safety and health.