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Evidence-Based Medicine”: Rationing Care, Hurting Patients

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Evidence-Based Medicine”: Rationing Care, Hurting Patients Jeffersonian Principles in Action December 2008 “EVIDENCE-BASED MEDICINE”: RATIONING CARE, HURTING PATIENTS by Twila Brase, R.N., P.H.N. Introduction This paper will explain the debate surrounding EBM, question the emphasis on evidence and Evidence is said to be the new bright star of guidelines for medical decisionmaking, demonstrate health care. A growing chorus of voices is calling for how EBM harms the doctor-patient relationship and physicians and other health care clinicians to follow why EBM won’t guard against frivolous lawsuits, “evidence-based medicine” (EBM) or so-called and describe various iterations of evidence-based “best practices.” To practice EBM, proponents say medicine being enacted and implemented today—in doctors must follow evidence-based clinical practice particular, Medicaid Preferred Drug Lists. guidelines. A word about terminology: this report uses At fi rst glance, this concept seems to make sense. “guidelines,” “best practices,” “practice parameters,” Any term with the word “evidence” automatically and “protocols” interchangeably. confers a sense of scientifi c authority. Assuming that to be true, the United States Congress and some state legislatures have begun adding “evidence-based” The Evidence-Based Medicine Debate requirements to health care laws. Several laws even Best Practices? link physician payment for medical services to Evidence-based medicine has been defi ned as compliance with EBM in an initiative called “pay for “the conscientious, explicit and judicious use of performance.” current best evidence in making decisions about the 2 Of concern to patients and doctors, the terms care of individual patients.” EBM advocates say “evidence-based medicine” and “evidence-based best evidence should be derived from the fi ndings of randomized controlled trials (RCTs)3—the so-called guidelines” are often not defi ned in these laws, 4 access to individualized care is not preserved, and “gold standard” in research—and meta-analysis, a the integrity of medical decisionmaking has not been systematic review of research studies. protected. Supporters of EBM argue that there are no systems in place for ensuring that best practices are Some say EBM is “the development of best 5 health-care practices based on data that show which consistently implemented. Many claim physician treatment and protocols work and which do not.”1 compliance with clinical guidelines—essentially practice directives—will reduce “overuse,” Others say EBM-based guidelines are dangerous, 6 7 outdated, value-laden, politicized, and biased. Claims “underuse” and “misuse” of health care services. of health care rationing have also emerged. According to the Institute of Medicine (IOM)—the federally funded organization providing the United 1101 Vermont Avenue, NW 11th Floor Washington, DC 20005 202-466-3800 f 202-466-3801 www.alec.org States Congress with health care policy research— To many doctors, these CPGs are viewed as a these three terms describe the primary “quality” regimented “cookbook” for patient care.18 According problem in health care today.8 to University of Pennsylvania Professor Arnold Rosoff, EBM supporters further claim, “Although we perceive the U.S. health care system as superior, “Some decry the spread of CPGs as the advent there are serious and widespread quality problems. of ‘cookbook medicine,’ having the potential to There is a gulf between ideal care and what actually turn doctors into automatons and lower the quality takes place.”9 Others point to a 2003 RAND study of health care by subordinating and subverting which concludes that Americans receive about half of professional skill and judgment.”19 recommended medical care processes.10 The American Medical Association is said to But some physicians, like Earl P. Steinberg, endorse guideline fl exibility that avoids “cookbook counter that assertion. Writing in The New England medicine.”20 However, guidelines often do not Journal of Medicine, Steinberg contends that the feel like guidelines. One doctor, talking about RAND study does not mean adults have only a 50 administrators who question his treatment decisions, percent chance of getting adequate care. Instead, he told The Seattle Times, “It’s always, ‘Why wasn’t it notes that the actual outcomes of patients may be done this way?’…From where I sit, I see guidelines much better than indicated by simply ascertaining become law, mandates.”21 compliance with a list of treatment protocols.11 More often than not, EBM proponents want Advocates say that the goal of EBM is the guidelines to feel like mandates. Steinberg later standardization, not individualization, of patient says he left the fi eld of health services research out care.12 But relatively few patients, perhaps less of frustration that health care was being “delivered than 25 percent, fi t the evidence-based therapeutic in a fashion that was [in]consistent with evidence- paradigm.13 In fact, individuals vary by physiology, based guidelines and the results of outcomes mental capacity, emotional stamina, time constraints, research.” Instead, he wanted to “try to focus on family and cultural considerations, fi nancial status, the development of practical tools to facilitate drug and food allergies, willingness to comply, ethnic compliance with what we already knew to be the right background, ability to travel, relationship resources, thing to do.”22 [emphasis added] and side effects to medication, among other factors. As genetic researchers increasingly demonstrate, Why Science Is Subjective patients are as different as their DNA. Built-In Bias Cookbook Medicine? What is the “right thing”? Researchers caution Clinical practice guidelines (CPGs) are the against depending solely on research evidence for 14 embodiment of evidence-based medicine. the answer, noting the potential for harmful bias HMOs and other managed care organizations in treatment decisions. Authors Ian Kerridge et al., began developing these guidelines in the 1990s to writing in The British Medical Journal, say, identify medical care they deemed inappropriate or unnecessary.15 As renowned Princeton University “[T]he large quantities of trial data required to professor and health economist Dr. Uwe Reinhardt meet the standards of evidence based medicine says, “EBM is the sine qua non of managed care, the are available for relatively few interventions. whole foundation of it.”16 Evidence based medicine may therefore introduce a systematic bias, resulting in allocation of Evidence-based treatment guidelines are being resources to those treatments for which there is developed to drive physician adherence to corporate rigorous evidence of effectiveness, or toward medical decisions. Some managed care executives those for which there are funds available to would prefer that physician training include show effectiveness (such as new pharmaceutical compliance training from the start.17 agents).”23 2 December 2008 Such allocation, they add, “My fear is that medicine will slide into the same intellectual morass in which economists “May be at the expense of other areas where now wallow, often with politics practiced in the rigorous evidence does not currently exist or is guise of science. In medicine, it might be profi t- not attainable (such as palliative care services). maximizing in the guise of science.”28 Allocating resources on the basis of evidence may therefore involve implicit value judgments, and Canadian physician R. Brian Haynes says it may only be a short step from the notion that evidence-based medicine is not authoritative in a therapy is ‘without substantial evidence’ to it medical decisionmaking. Invited to travel from being thought to be ‘without substantial value.’”24 McMaster University in Canada to present at a federally-funded U.S. conference on medicine and Dr. Gary Belkin, author of one of the most law, Haynes told the audience, comprehensive papers on the motivation and philosophy behind EBM, further questions the “Evidence-based medicine in practice defi nes the scientifi c claims purported by managed care: likelihood of something happening. It is never 100%. It is not absolute truth. Evidence never tells “[T]echniques that people see as objective proof, you what to do. The same evidence applied in one when more carefully examined, are easily seen case may not apply in another. The circumstances to be the result of a multitude of subjective of the individual may be different, or the choices (my subjectivity of objectivity). Health circumstances may be the same, but patients may services research and the foundational practices of refuse one treatment in favor of another. What managed care that...appear to offer new scientifi c evidence-based medicine does is inform one about rigor to medicine are a perfect example of this. what the best options are—but it doesn’t make the decision.”29 “Measuring outcomes of medical interventions and paying for, approving, and rewarding those Belkin critiques the evidence-based scientifi c treatments with desirable outcomes seems focus of medicine today, writing, “There is great obvious, straightforward, and long-delayed. But variability within scientifi c communities as to what the value-laden nature of what is ‘desirable,’ the evidence, techniques, assumptions, and so on, count innumerable choices and disagreements as to as scientifi c.”30 He adds, outcome variables, interventions, and observed population defi nition, make the measuring of “Social roles, needs and political agendas often outcomes anything but straightforward.”25 determine what scientifi c
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