Limits of Science and Boundaries of Access

OUP UNCORRECTED PROOF – First Page Proofs, 28/03/2012, CENVEO

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Limits of Science and Boundaries of Access

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Alternative Health Care

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E . H A AV I M O R R E I M

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INTRODUCTION Recent years have witnessed a rapid growth of interest in complementary and alternative medicine (CAM)—approaches to health, illness, and healing that often differ markedly from conventional Western medicine. The range is broad, from spiritual and mind-body approaches, to manual healing approaches, to dietary and nutritional emphases and beyond.1 Eisenberg et al. found that in 1990 Americans spent nearly $14 billion on such alternatives, three quarters of that sum out of pocket. There were more visits to unconventional providers than to all primary care physicians combined, and the people most commonly using alternatives were relatively affluent and well educated.2 By the time Eisenberg et al. revisited the question in 1997, there had been a 47% increase in the number of visits to alternative practitioners, and a 45% increase in spending. The great majority of people declined to tell their regular physicians about their use of alternative care.3 Several years later another study showed that nearly 68% of people used at least one CAM modality during their lifetime, and that this proportion has increased steadily since the 1950s.4 Meanwhile, funding for scientific research into CAM modalities has grown from $2 million in 1992, when Congress established the Office of Alternative Medicine at the National Institutes of Health (NIH), to $50 million when that office became the National Center for Complementary and Alternative Medicine in 1998. By 2003, overall NIH funding for CAM research had increased to over $220 million.5 Commentators point to a variety of factors behind this rising interest. Medical science achieves dazzling rescues for life-threatening illnesses but offers rather less for debilitating chronic illnesses. Moreover, some of the alternatives at

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which Western medicine once scoffed are now seen to have merit, including acupuncture, chiropractic, guided imagery, support groups, nutrition, herbs, even leeches.6 Additionally, physicians working under “productivity” expectations have less time for the personal touch many patients deeply desire. Partly through these limits, and partly through headlines trumpeting medical errors and malpractice litigation, physicians’ halo seems a bit tarnished. Across the spectrum of these changes, society faces some interesting issues. On the one hand, many people believe they should have better access to alternative care, and some health plans and even legislatures have expanded financial coverage for patients to visit nonmedical providers.7 On the other hand, with annual costs of health care roughly $2.5 trillion dollars,8 and with millions of Americans soon to be added to the ranks of the insured, many critics caution against wasting money on alternatives that may be quackery.9 As we assess such criticisms and consider whether society should accept or perhaps even fund alternatives, we need to look at a few issues more deeply. In particular, it will be important to examine the view that alternative modalities should be accepted—or more commonly, rejected— on the basis of their scientific validity. As this essay will argue, these critics tend to overestimate the extent to which traditional medical practice is science-based, while potentially underestimating the value of at least some alternative modalities. Instead, a temperate approach should guide our decisions about whether and when society should accept or fund access to alternative health care. This essay does not purport to resolve these difficult issues, nor should it be read as an assault against conventional Western medicine. Rather, the goal is to dislodge a few preconceptions and

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dilemmas and priorities

thereby to enable a fresher, more carefully reasoned assessment as we weigh profoundly different healing approaches against one another.

R A D I C A L LY D I F F E R E N T PERSPECTIVES Perhaps the most common complaint about alternative modalities is that they typically embrace metaphysical entities and forces that cannot possibly be evaluated scientifically. For instance, “[i]n many traditional medical systems, the primary explanation for biological phenomena is based on the existence of a ‘vital force,’ an elusive entity designated Qi in China, Ki in Korea and Japan, prana in India, and vital force in Western traditions (e.g., homeopathy).”10 In Chinese medicine, qi is said to move “through the body along invisible meridians. Good health depends on the proper flow of this energy; disease and pain are the result of qi out of kilter.”11 Such invisibles, postulated to be the foundation of both wellness and disease, inherently elude the scientific measurement that is the hallmark of Western medicine, thus inviting some commentators to conclude they must surely be fictional.12 Moreover, critics argue, such fantasies can usually be explained much more straightforwardly. Where that is the case, then “we have wasted a lot of time and effort. The time has been wasted on all the people who have spent years learning falsehoods about acupuncture points and the principles of homeopathy. And the patients have wasted their time, money, and efforts receiving treatments that were not what they were represented to be or were harmful.”13 Such criticisms seem to presuppose that medicine itself is free of metaphysics—that the science on which it relies is the direct, unencumbered product of observation available to all who care to look, leading to conclusions that are available to anyone who cares to be rational. No unseen “Mysterious Forces.” On closer inspection, however, medical science has a rich metaphysic of its own. It presupposes a certain picture of the way the world is and how it functions. That picture has its distinctive epistemology (i.e., its own description of how we identify and gather knowledge), and on the whole is just as unprovable as any spiritual entity or life-force. Several elements are prominent in this implicit picture. First, the world is seen to be finite and sensible. That is, its constituent entities are observable to the senses, and can be measured and counted.


If something can’t be observed, measured, and counted, then it is “off the radar screen,” at least from the perspective of medical science. Second, it is assumed that all people with the requisite sensory capacities have basically the same sensory experiences of the world, so that observations about the world’s phenomena are intersubjectively confirmable. Thus, what I personally experience in association with the words “blue” or “acrid” is essentially the same as your experience. A phenomenon or experience that only one person can perceive is relegated to the domain of anecdote or even illusion, not a fit object of scientific knowledge. Third, the world is deemed thoroughly orderly, and this order persists through time via immutable laws of nature. Ultimately everything can be explained by being subsuming under broad laws of nature, and accurate generalizations will be just as true tomorrow as they are today. Otherwise there would be no point in doing science at all, because we could not build our knowledge over time by relying on yesterday’s observations as we add today’s. In this way, the truths of science are found in reliable patterns, not lone events. Finally, science holds that understanding the laws of nature gives us predictability and control. We can use the forces of nature as tools to make things happen the way we want them to, at least up to the limits of our knowledge and power. Although these precepts are regarded as obvious and immutable truths, such empiricism and materialism14 are no more “provable” than qi, prana, or any other metaphysic. Philosophers have long pointed out, for example, that no argument or evidence can possibly justify our presumption that the world is orderly or that this order must persist over time. Illustrating this “problem of induction,”15 as it is called, they note that we cannot conclude the sun will rise in the east tomorrow by pointing to the fact that it always has done so in the past. After all, the reliability of the past as a predictor of the future is the very issue in question. Neither can we prove that everything in the world is (at least in principle) available to human empirical observation and measurement, because we cannot possibly see what is beyond human vision nor can we hear what is beyond our auditory apparatus, in order to document that “there’s nothing more out there.” The upshot is that, for any healing approach, whether religious, metaphysical, or scientific, certain fundamental beliefs must simply taken as “givens” without any possibility of conclusive

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proof, lest we land in an infinite regress of proofsfor-the-proof. Accordingly, on the epistemic plane at least, we are left with a collection of irreducible contrasts. Just as science assumes everything is controlled by natural laws, a religious approach may hold that its healing God is not obligated to follow laws of nature, because the God who made those laws can change or override them at will. For Western medicine, even thousands of years of accumulated experience within a given tradition, such as Ayurvedic medicine, will not count as evidence in the absence of properly controlled trials to distinguish between a law-governed pattern and pure happenstance. In contrast, many alternative approaches are willing to find knowledge in received traditions, in lone events, or in subjective experiences such as personal revelations from a deity. Each perspective then interprets its successes or failures from within the rules and framework of that perspective. The faith healer will confront a failure with “he just needed a little more faith” or “God works in mysterious ways.” He will not conclude, if his patient dies, that “there is no God, after all.” By the same token, the physician whose patient dies will not conclude that “science is bogus.” He will say we just need a little more data or perhaps a better theory. Analogously, where an alternative approach ostensibly cures a patient whom medicine had declared to be incurable— the “miracle” cancer cure—the medical scientist will not conclude the alternative approach is correct after all. Rather, he will question the original diagnosis or call the healing unexplained, with the proviso that one day it will be scientifically accounted for. In this way, conventional medicine stands philosophically more on a par with alternatives than its proponents may recognize. If Western medicine can criticize Chinese medicine or faith healing because it “violates fundamental scientific laws,”16 an alternative approach can criticize medicine for its own failure (e.g., to honor the supreme principles of balance and harmony in the universe). Each criticism is made from within a framework that is itself presupposed to be true.17

MEASURING UP TO S C I E N C E Proponents of conventional medicine have sometimes proposed that alternatives might be acceptable, but only if they measure up to the rigorous standards of science. There are two problems with such a requirement. First, many alternatives are


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not conceptually oriented toward the tidy world of measurability, quantifiability, orderliness, predictability, and control embodied in a scientific approach. To require them to do so would be to distort their essential character. Second, often medical practice itself cannot measure up to its own scientific standards, for reasons of both principle and practicality. Hence, this section will suggest that a rigid demand for thoroughgoing science cannot be met even by medicine, and hence should not necessarily be required of alternatives.

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Science and Alternatives From some alternative approaches’ perspective, gathering empirical data is a fundamentally wrong-headed way to search for truth. Spiritual healing, for instance, may emanate from historic teachings or divine revelations that come through opening one’s heart rather than opening one’s eyes, ears, or toolbox. Other kinds of alternative medicine are more amenable to tracking empirical connections between healing inputs and patients’ outcomes. But they do not necessarily lend themselves well to classic science, in which study subjects are narrowly selected to exclude confounding factors, and in which all study subjects receive the same inputs in order to facilitate the cleanest statistical analysis. Homeopathy, for instance, emphasizes highly individualized diagnoses and treatments— not entirely compatible with the standard randomized controlled trial (RCT) in which everyone in a given arm of a study receives exactly the same dose of the same treatment.18 Analogously, acupuncture cannot easily accommodate classical placebo controls without introducing conceptual distortions into its theory and practice.19 Accordingly, to require alternative modalities to meet medicine’s criteria of scientific validity may do them an injustice. A science-style “controlled evaluation of alternative medicine therapies may require its practitioners to undertake a fundamental conceptual shift from a view of patients as requiring individualized treatment that may vary at each session to one in which trial participants are regarded as members of an equivalence class, defined by the diagnosis, who all will be given a standard prescribed treatment.”20 Again, this does not entail that alternatives are excluded from science altogether. More will be said on this below. But it may mean that the science by which they are evaluated may look more like paleontology or geology than like highly controlled laboratory experiments.21

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Science and Medicine If various alternatives do not quite fit with classical bench science, conventional medicine actually shares that difficulty. There are many respects in which medical practice does not, and in important respects can never, meet its own scientific ideal. The reasons are both philosophical and practical. Philosophical Obstacles to Science in Medicine Science’s focus on that which can be defined, observed, measured, enumerated, and statistically analyzed tends to leave out whatever is not amenable to such precision. If something can’t be counted, it doesn’t count. And yet even devoted scientists recognize that this rigorous standard leaves out many factors that can be hugely important in medicine and other human endeavors.22 For instance, one obviously important aspect of health and health care is quality of life. Although various measures are available, none is entirely satisfactory.23 We can itemize and tally the physical impediments in a person’s life, for example, yet we know well that some people with grave disabilities will deem their quality of life to be excellent, as they find joy and meaning in things that able-bodied persons might overlook. As a result, many studies of medical interventions look only at the intervention’s effects on major morbidity and mortality, while those that do assess quality of life (QL) are subject to criticism because the QL measures are so flawed. An even more potent example is the placebo effect. Although placebos usually take the form of a pill, injection, or infusion with no medically active ingredient, the more important factor is the placebo effect—that is, the power of belief, expectation, hope, and trust that comes with the patient’s anticipation of healing. With placebo alone, patients can experience marked improvement in their condition, or can even suffer significant side effects.24 That much is well documented. This effect can be so powerful it will confound virtually any research if not appropriately controlled for. Indeed, evidence indicates that the placebo effect may actually be growing more powerful in recent years.25 Hence, gold-standard science requires double-blinding: where neither the investigator nor the subject knows which treatment he is receiving, it is more difficult for their hopes and expectations to precipitate biological changes that could distort any findings regarding the drug, device, or other intervention under study.26


Interestingly, however, once such carefully controlled research has deemed an intervention effective, placebo tends to be regarded essentially as “nothing,” so that the conclusions investigators draw from their research typically imply that the active intervention is better (or not) than no treatment at all. Sullivan explains the implications:

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The healing power of the placebo arises from the therapeutic encounter and alters the physiology of the body according to the nature of that encounter. It is unlikely that this power has any single biochemical identity within the body throughout its varied applications. It is thus essentially different from the specific/ pharmacological healing proffered by orthodox medicine. . . . Within placebo-mediated healing, knowing and healing are directly linked. A shift in beliefs is therapeutic. . . . [Thus, p]lacebo-induced therapeutic changes are specifically those successes which are illegitimate for orthodox scientific medicine.27

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The result is almost paradoxical. On the one hand, medical science recognizes the extraordinary power of placebo, and must design research around its overwhelmingly confounding effects. Yet in the aftermath of those studies, medicine relegates this avowedly powerful mode of influencing body processes to merely the “art” of medicine. It is not an art that many physicians study or cultivate, and when alternative healers harness it effectively, it is usually disdained as “mere” placebo.28 Reciprocally, if a patient is made considerably better by placebo, a common inference is that the problem must not have been real to begin with. So, one wonders, which is it: a force so powerful it can thwart the best research and overshadow powerful medicinals, or a meager result that alternative approaches produce because they cannot produce genuine healing? Aside from discounting whatever cannot be precisely measured and enumerated, medical science faces other philosophical limits. Ethical constraints, for instance, restrict research topics and methods. Theoretically, the best way to learn how a new drug treats an illness would be to give people the disease—exactly the same strain of the bacterium or virus to each person—and then administer the drug and measure its effects. But such a research design is ordinarily unethical, and so we must find people who already have the illness in question. And then we can only request, not require, them to participate. In the same vein,

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randomization is sometimes precluded by patients’ preferences. In studies comparing lumpectomy with mastectomy for breast cancer, women’s refusal to leave such an important choice to chance required modification of the usual randomization procedures.29 Ethical concerns have also constrained testing potentially harmful drugs on children and pregnant women, and have limited the use of placebo (“sham”) arms in surgery trials. Efforts are emerging to improve the rigor of surgical research.30 Similarly, requirements have emerged to test products more thoroughly on women and children,31 because where these populations remain untested, then in essence the intervention is experimental for everyone. Still, such research can only place limited risk on study subjects.32 Accordingly, the rigor of research designs must be attenuated to accommodate other values. In sum, science cannot, even in principle, tell us about everything that is significant in illness and healing. Important factors will always be left out, namely those that aren’t amenable to satisfactory quantification and those that cannot be studied for other reasons, such as ethical constraints.

Practical Obstacles to Science in Medicine Science in medicine also faces practical constraints. For instance, it is impossible to do double-blinded trials in surgery, since obviously the surgeon must see what she is doing. Likewise, differences in skills among practitioners, and evolution of each practitioner’s skills over time, are difficult to control for. The same is true for psychotherapy, which is additionally complicated by variations in the interpersonal chemistry between individual therapists and patients. Research is also very costly, particularly because studies must usually be large in order to attain statistical significance. We cannot afford to study everything that needs scientific evaluation, nor to replicate important results, nor to undertake new studies every time a technology or its use is revised. Further, funding for the great majority of medical research comes either from manufacturers of drugs, devices, and other products, or from government. Thus a research proposal must usually be either commercially or politically attractive if it is to be funded.33 Garas et al. observed this close connection between science and funding in conjunction with clonidine, a very effective and inexpensive drug for congestive heart failure:


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despite multiple efforts, there has been no interest so far from anyone to fund large controlled studies to demonstrate the long-term impact of these alterations on patient outcome. The clinically observed benefits of clonidine in heart failure are known to a small circle of academic cardiologists, but the primary care physicians who treat 90% of patients with chronic heart failure are totally unaware of them.34

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As a result of these myriad impediments, many important topics in medicine have never been studied, or are not studied soon enough.35 For instance, as of 1988, a national conference on antithrombotic therapy (anti-clotting treatments used to prevent stroke, pulmonary embolism, and the like) evaluated the scientific foundation for various recommendations on which physicians based treatment. The American College of Chest Physicians found that only 24% of those recommendations were based on appropriately scientific studies, while 55% were based on uncontrolled clinical observations. Ten years later, 44% of the recommendations were science-based, though this was largely because of Food and Drug Administration requirements for the testing of new drugs.36 Similarly, although coronary artery bypass surgery was first performed in 1964, its efficacy was not scientifically evaluated until 1977; likewise, angioplasty to open up clogged arteries in the heart was “performed in hundreds of thousands of patients prior to the first randomized clinical trial demonstrating efficacy in 1992.”37 “When The U.S. Preventive Services Task Force reviewed more than 6,000 studies on 200 clinical preventive practices, it concluded that very few are supported by sound scientific evidence.”38 The now-defunct Office of Technology Assessment “estimated that fewer than 30% of procedures currently used in conventional medicine have been rigorously tested,” and some other assessments conclude the figure is even smaller.39 Aside from these significant limits on the content and scope of scientific research, the translation of research into the clinical care of individual patients deviates even further from science. For one thing, physicians may not always quickly adopt well-documented findings. “In the current health care system, scientific knowledge about best care is not applied systematically or expeditiously to clinical practice. An average of about 17 years is required for new knowledge generated by randomized controlled trials to be incorporated into practice, and even then application is highly uneven.”40

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Additionally, the more pristine the science, the less it is applicable to actual clinical care. This is because, to test strictly for the effects of a specific drug or procedure, study design must be limited to patients fitting a narrow set of eligibility criteria—typically, patients with a minimum of other diseases and medications that could confound the results.41 Once the study is complete, however, its findings are applied to all those complex patients who would never have been eligible for the study.42 Thus, the more perfectly scientific and highly controlled a study is, the less its enrolled subjects resemble the ordinary souls, with their multiple problems, for whom ordinary physicians care. One result of this misfit between the research populations and the broader clinical population is that sometimes even well-researched new drugs and procedures must be quickly withdrawn from the market because of unanticipated problems. Between September 1997 and September 1998, five FDA-approved drugs were removed from the market because of unexpected side effects or interactions with other drugs. For instance, by the time mibefradil (Posicor) was removed, it was known to interact with 26 different drugs.43

Implications Between the dearth of studies and the compromised applicability of existing studies to the care of individual patients, physicians would be hard pressed to claim that their care is exclusively or even primarily a direct application of science to practice. This is not to deny that clinical medicine is science-based in many respects. Physicians are increasingly practicing “evidence-based” medicine, in which the routine care of routine situations is based on the most up-to-date, scientifically validated approaches to a given problem. Additionally, there are many illnesses and injuries for which a broad consensus can guide care. In puzzling situations physicians can also of course refer to their basic knowledge of human physiology, anatomy, and the like, to hypothesize what should, in theory at least, be the right approach for the patient. While important and useful, these strategies cannot entirely compensate for the lack of studies or for the limited applicability of existing studies. In actual practice, “doctors usually rely on a combination of habit and casual intuition, using tests and treatments they are familiar with, have heard good things about, or seem to work in test tubes or laboratory animals.”44


Moreover, treating patients on the basis of hypotheses, absent real research, can be disastrous. Two examples of theoretically attractive interventions can show those hazards. Pulmonary artery catheterization, widely in use for three decades, eventually came under scientific scrutiny as reports began to suggest it may actually do more harm than good.45 Similarly, high-dose chemotherapy with autologous bone marrow transplantation was used to treat breast cancer for more than a decade. There was never any real evidence the treatment would work,46 only a bit of theory and physicians’ desire to do something—anything—to help patients for whom they had little to offer. Not until 1999, when studies were finally completed, did it become evident that the treatment was no better than conventional chemotherapy.47 Numerous treatments in the history of medicine have been widely adopted and then later found to be ineffective.48 The upshot is a mixed review. Medicine can justly pride itself on a wide array of stunning successes, attributable in large part to scientific research. At the same time, science cannot possibly be the sole basis on which physicians care for patients. There is too much that has never been studied and too much that, for many reasons, can never be adequately studied. Much research leaves out or vastly underrates avowedly important aspects of illness and healing, and even the best studies cannot be applied in any straightforward way to individual patients. Physicians’ practices vary widely, in ways that cannot be explained by differences among patients.49 As a further practical reality, physicians’ actual practices often do not implement what science is available. Overuse, underuse, and misuse of recognized treatments is now recognized as a major problem throughout medicine.50 Although best-evidence approaches are steadily improving clinical care, large portions of medicine are not, and never will be, scientific. Interestingly, many practicing physicians have articulated a similar conclusion when protesting managed-care efforts to reduce the variation in clinical practices or to control costs.51 Partly they note that many of the guidelines on which health plans rely are not based on good science.52 But even with scientifically credible guidelines, medicine cannot be practiced by “cookbook,” they argue, because no guidelines can be sufficiently accurate, complete, up to date, and detailed to dictate the care of specific patients; care must be individualized. This becomes, perhaps, the most important conclusion from all the foregoing discussion: medical

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research and clinical care, while related, are very different enterprises. While the former can strive for great precision in the strongest traditions of science, the latter will forever be a far more intuitive, use-your-best-judgment, rely-on-experience, kind of enterprise—the “art” of medicine. It is the very sort of cumulative experience-based healing on which many alternatives also heavily rely.

ADDRES SING THE T E N S I O N S : H OW S H O U L D H E A LT H PLANS RESPOND? At this juncture important questions arise concerning how society, and its health plans in particular, should respond to the public’s increasing interest in alternative approaches. Simplistic answers will not suffice since, as observed above, medicine cannot fully conform to its own scientific ideal, and in any case science cannot claim a monopoly on effective healing. A temperate approach thus seems appropriate, acknowledging that there may be more than one way to understand what illness is, and that healing might come through a diversity of avenues. As an initial move, it is important to avoid double standards that would hold alternative modalities to a standard of proof that medicine itself cannot meet.53 When alternative providers emphasize individualizing care they should not be called “unscientific” if, at the same time, clinical physicians who likewise individualize their interventions are approvingly regarded as practicing the “art” of medicine.54 The successes of alternative modalities cannot be dismissed as mere “anecdotes” and “testimonials,” if we accept as authoritative physicians’ statements that “my patients have done well/poorly with this treatment,” or “in my clinical experience X has worked well.” When alternative providers invoke the power of belief and expectation it should not be dubbed “mere placebo,” if at the same time we permit physicians to invoke the “power of the white coat” or to foster “a certain mystique” in the physician–patient relationship. An alternative practitioner is not “peddling false hope” if, in a comparable situation, physicians might paint overly optimistic pictures on the ground that “we can’t take away the patient’s hope.”55 At the same time, even an open-minded approach to alternative treatments does not resolve the challenges that health plans and society now face. If some alternatives offer bona fide help for some patients and some conditions, there is also


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undoubtedly a significant measure of quackery and sheer hucksterism in the current turbulent health care market. Society thus faces an array of questions, such as whether to regulate alternatives, requiring them to demonstrate that they are at least safe if not also effective; whether to license alternative practitioners such as homeopaths or acupuncturists and, if so, how to set the applicable standards; and whether to add any alternative healing modalities to government-sponsored health plans such as Medicare, or to require such coverage in federal employees’ health plans. Such societal issues are beyond the scope of this essay, but it will be useful to explore a related question: how health plans should respond to increasing pressures to cover alternative care. The issues will not be resolved in this brief forum, but a few basic considerations can be suggested. We will first consider benefits and harms, then economic concerns.

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Benefits and Harms Perhaps the most powerful reason Western medicine has such pre-eminence is the simple fact that, for many diseases and injuries, its treatments often work well.56 Infectious diseases are a classic example: a pathogen is identified and drugs are developed that literally, dramatically, save a life. Organ transplants, joint replacements, and limb reattachments are but a small sampling from the rest of the list. Still, it is widely agreed that there are many problems, particularly those involving chronic illness, that medicine does not address so well. Moreover, medicine’s treatments sometimes carry a terrible price. One meta-analysis found that more than 100,000 persons die annually from adverse drug reactions in U.S. hospitals, placing these events between the fourth and sixth leading cause of death.57 Many of those drug reactions are not the product of error, but rather are side effects reflecting a known incidence whose possibility has been accepted as part of a risk–benefit assessment. In a related area, a widely cited study by the Institute of Medicine estimated that as many as 98,000 people per year may be dying from medical errors—ranking medical error as the eighth leading cause of death, killing more Americans than motor vehicle accidents, breast cancer, or AIDS.58 To be sure, one cannot blame conventional medicine per se for these errors. And yet health care delivery has become so complex that quite likely some significant level of error will always be a problem, even if that level can be reduced from present levels.

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On the other side of the coin, relatively few data have been gathered regarding the risks of various alternatives, though surely there are hazards. Herbal preparations, for instance, can react with other drugs, although exact profiles have yet to be established. Manufacturing problems can hamper quality, and there may be toxicities that have not yet been precisely identified.59 In the same vein, chiropractic, improperly applied, can potentially cause serious injury. Nevertheless, many alternative approaches, such as acupuncture, homeopathy, biofeedback, or guided imagery,60 use such noninvasive, benign modalities that they pose few obvious risks so long as they do not prompt patients to forego treatments of proven value. At the same time, many patients have found great benefit in alternative treatments—enough value that by the late 1990s they were willing to invest over $20 billion in alternatives, including more than $12 billion out of their own pockets— more than the out-of-pocket expenditures for all U.S. hospitalizations.61 Willingness to pay does not equate with successful outcomes, of course. And yet it is reasonable to suppose that some significant measure of value was perceived, or else these figures would not have risen so markedly from earlier counts.62 If this risk–benefit picture is anywhere near accurate, it is difficult to argue that alternatives should be simply forbidden, or even that people should always be required to try Western medicine first. Autonomous adults are entitled to make their own choices for their own reasons, even if sometimes foolishly.63 In fact, use of alternative modalities generally appears to be quite judicious. Most people still seek out Western medicine where it offers clear, major benefits, and turn to alternatives where medical science has the least to offer—chronic illnesses, disabling conditions, medically incurable diseases, and the like.64 The major exceptions include people with univocal dedication to a faith tradition such as Christian Science. Accordingly, so long as an alternative is not demonstrably harmful or fraudulent it ought, prima facie at least, to be permitted. If various alternatives should still be freely available in the marketplace,65 the more pressing question is whether and under what conditions health plans should cover them.

criteria come to mind. As a first attempt, if one wants to be sure that the common funds health plans use for all their enrollees are not wasted, one might propose that plans should cover only interventions that are shown to be of value by the bestquality science. Such a stiff criterion must quickly be discarded, however. As noted above, many well-accepted areas of medicine, from surgery to psychiatry to epidemiology, do not always lend themselves to classic “gold-standard” RCTs. And much of clinical medicine can make only limited use of RCT science, since ordinary patients are more complex than the narrowly chosen population in research trials. This first criterion would surely save money, but only by denying patients a wide array of helpful care—hardly the purpose of a good health plan. An alternative, looser criterion might require that there be at least some science to substantiate the value of an intervention, or a healing approach, before it will be covered. There is much to recommend this criterion. One reason an empirical, science-based approach is attractive is its intersubjectivity. We needn’t simply trust one person’s report that something works or doesn’t; we can use a fairly clear set of rules for gathering evidence via shared observation, and for discerning which conclusions are warranted by that evidence. We can be reasonably confident that treatments passing such a test will work for many people, even if there is no guarantee. Indeed, the Institute of Medicine issued a report in 2005 recommending additional research and identifying a variety of methodologies that can be acceptable ways of exploring CAM.66 By data on Medline’s indexing services, articles on CAM research increased from fewer than 200 in 1982 to more than 7,500 by 2008.67 When common funds are involved, that intersubjective agreement is appealing, because we want shared resources to be well used. At the same time, it should be recognized that simply obtaining information about relevant research in the area can be challenging.68 In that spirit, a number of studies suggest that, under such a criterion, health plans might have reason to cover a number of alternative modalities, although close attention to mixed evidence would seem to be indicated. Research has suggested that:

Costs and Coverage As we consider whether health plans should cover alternatives, and if so which ones, several potential

*Transcendental Meditation appears to be just as effective as drugs in the treatment of mild hypertension.69


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* Spinal manipulation may be the most effective, cost-effective treatment in many cases of acute low back pain, and as well for acute and subacute neck pain.70 * Hypericum perforatum (St. John’s wort) does not appear effective for treatment of ADHD in children and adolescents.71 * Echinacea does not appear to provide statistically significant relief for cold symptoms.72 * Auricular acupuncture appears to be of significantly greater value in treating cocaine dependence than relaxation treatment or “sham” needle insertion.73 * Glucosamine combined with chondroitin does not appear to be better than placebo for symptomatic osteoarthritis of the knee.74 * Individualized Chinese herbal preparations can be of significant value in treatment of irritable bowel syndrome.75 * Herbal remedies such as black cohosh appear to be no better than placebo for relief of menopausal symptoms.76 * A yoga-based regimen is more effective than wrist splinting or no treatment in relieving symptoms and signs of carpal tunnel syndrome.77 * Saw palmetto extract produces similar improvement with fewer side effects in the treatment of benign prostatic hypertrophy, compared with the drug finasteride.78 * Asthma patients who wrote about their stressful experiences in a journal experienced significant, clinically relevant changes in their health status.79 * Horse chestnut seed extract is significantly effective in treating chronic venous insufficiency.80 * Willow bark extract may be safe and effective for exacerbations of low back pain.81 * A specific nutrition regimen can not only stop but reverse some coronary artery disease.82 * Aromatherapy has shown success in treatment of alopecia areata.83 * Remote intercessory prayer appears effective in improving the overall condition of critically ill patients and may be an effective adjunct to care.84


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* Weekly support groups and self-hypnosis were associated with doubling the survival of women with advanced breast cancer,85 and other CAM modalities such as relaxation, acupuncture, and imagery appear helpful generally for patients with cancer.86 Thus, this second, looser criterion would admit a much wider array of care, both conventional and alternative, than the first one. Yet even here, some very helpful modalities might still be excluded. After all, Western medical practice unavoidably goes well beyond the limited number of studies for which scarce research funding is available, and a mandate to provide specific scientific backing for each intervention—even shy of gold-standard RCTs—would obligate us to throw out a substantial portion of day-to-day medicine. Up to a point, such pruning would be desirable. The quest for evidence-based medicine is based on a growing recognition that medical care could and should be more effective, and that ineffective care can cause harm as well as waste resources. Still, a requirement that every intervention have at least some specific scientific support would arguably be hasty. From the bare fact that “there is no evidence” it is simply fallacious to conclude “there is no value.” There is simply not enough money to study everything that merits research, whether conventional or alternative. And so it is certain that some quite clearly useful interventions will never have their value adequately documented. However, once we embrace unsubstantiated conventional medicine, it is not clear on what grounds we can exclude equally unsubstantiated alternative treatments. As pointed out earlier, some alternative modalities, such as spiritual healing, do not lend themselves to standardization and quantification, yet this does not mean they are worthless. We remain in a quandary, then, if our objective is to draw some sort of fairly “bright line” between that which health plans should fund and that which they should pass by. A third criterion might focus on avoiding waste and harm. There is wide agreement that conventional medicine has enormous benefits for most people, and thus is unlikely to waste much money. In contrast, so long as alternatives have only minimal scientific documentation, the argument might go, they should find their own funding. If and when a particular alternative approach gains scientific ascendancy by proving its worth, then health plans can accept it for coverage.

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This approach may sound initially attractive, because it resembles quite closely what most health plans already do. However, its problems quickly become evident. A closer look at conventional medicine suggests that the vast amounts of money it sometimes wastes can make the costs of alternative approaches pale by comparison. During the decade in which 30,000 women received bone marrow transplants for breast cancer, as described just above, some $3.4 billion was spent on this non-beneficial, and often harmful, treatment.87 In the process, additional enormous sums were spent on hundreds of lawsuits that often required plans to pay for the treatment and in some cases levied millions of dollars in punitive damages against plans.88 Many families incurred overwhelming personal debts, sometimes losing their homes and retirement funds,89 to pay for the treatment because doctors said it represented the patient’s best or only hope. In another example, arthroscopy and lavage for osteoarthritis of the knee was once a common procedure, provided to more than 650,000 per year. At $5,000 each, the total cost was $32.5 billion each year. Although uncontrolled studies suggested that it improved patients’ comfort and function, eventually a carefully conducted randomized, placebo-controlled trial, in which both patients and outcomes assessors were blinded, concluded that the procedure was no better than sham surgery.90 Other once-popular, later-disproven treatments tell similar tales of wasted money, from glomectomies for asthma, to photodynamic therapy and organic solvents for herpes simplex infection, to gastric freezing for ulcers.91 To these we can add ongoing instances of overuse,92 such as prescriptions for antibiotics that are either clearly unnecessary or more powerful and costly than the patient’s illness requires. As also noted above, physicians’ clinical practices are seen to vary widely, in ways not justified by differences in patients’ conditions.93 While we cannot be certain “which rate is right”94 for various surgeries, diagnostic interventions, and drug prescriptions, it is safe to suppose that at least some of this variation represents unnecessary care and thereby additional wasted money. Decades of generous fee-for-service funding, combined with defensive medicine and other inflationary pressures, have almost certainly raised medical customs to a level above that which is truly useful. If high-technology Western medicine is thus capable of such size-large, unwise expenditures, it


would be awkward to conclude that alternatives should be automatically excluded from coverage simply because they might waste money. At the same time, a reciprocal point should also be emphasized. The bare fact that an alternative may be cheaper does not mean it should be endorsed, let alone favored. As health plans, and the governments and employers who purchase most of them, face relentless pressures to contain the costs of care, and as more information comes to light about the limited evidentiary basis on which conventional medicine often must practice, the possibility exists that plans will not only cover alternatives, but might even mandate or at least encourage their use in cases where there is no evidence to show a superiority of costlier conventional modalities. However, just as “no evidence” does not mean “no value,” neither can we conclude that, where two interventions that are equally unsupported by evidence, the two must be equally good. Accordingly, perhaps the proper task should not be understood as a need to identify some criteria by which health plans will “correctly” include or exclude this or that healing modality. Rather, the proper task should be for health plans to find ways to shepherd their resources prudently, whether for conventional or for alternative remedies, while maximizing the good those funds achieve.

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Promoting Good Care Within Prudent Limits A balanced approach would seem to need several elements. First, plans should leave room for patients themselves to define what constitutes the “good” that health care will provide for them. So long as the evidence is equivocal regarding the benefits and harms of so many modalities, and so long as some of the alternatives that people find very helpful are not amenable to scientific quantification, across-the-board exclusions of alternatives seem inappropriate. Perhaps a reasonable approach might use the test of time. Longstanding traditions with widespread support, such as acupuncture or chiropractic, might be more readily embraced, while giving “overnight sensations” less credence if they cannot provide more substantial evidence of value. Such an approach would essentially be equivalent to the “physician acceptance” standard that many plans currently include for determining whether a new intervention is “medically necessary” or is instead “experimental.” Second, health plans need not all have identical coverage. For a variety of reasons that are

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discussed elsewhere,95 plans should be permitted openly to provide varying levels of coverage, ranging from basic care to more generous packages. In this setting, the most basic plans might limit coverage—whether of medical or of alternative interventions—to care that has been reasonably well demonstrated to be safe and effective. Broader packages might include various alternatives, alongside broadening access to less well-proven medical procedures. Third, plans can institute some of the same kinds of cost containment for alternative treatments, ranging from incentive systems to utilization management and fee scales, that they now exert upon conventional medicine. Admittedly, there is hot debate concerning how appropriate these economic measures are. And yet with the rising cost of care, and millions still uninsured, some kind of cost control is as appropriate as it is inevitable. Arguably, patients should play a role in the cost containment that governs their own care. The point will be made only briefly here because it has been detailed elsewhere.96 In a system where patients share in the costs of their own choices, as where patients have high deductibles accompanied by health savings accounts to cover those costs, they have reason to be prudent about the value and the cost of their requests. These financial incentives should not pose barriers to needed care, but they should provide rewards for prudence and an opportunity to consider carefully which care is worthwhile. An array of options have been described, from graduated copays for prescription medications, to health savings accounts,97 to other options. Via whatever plan, the more patients take responsibility for their own utilization management, the less health plans will need to dictate, detail by detail, what they will receive, and the less plans may feel impelled to incentivize physicians to work against their own patients. Where patients have access to alternative modalities, combined with incentives to be prudent, health plans can conduct a further kind of research, assessing which alternatives their enrollees actually prefer, whether those modalities produce favorable outcomes, and how the costs for patients who use alternative treatments compare with those who use only conventional providers. It might be found that a fairly broad access to alternative modalities can actually save money, for instance, if people suffering from somewhat vaguely defined conditions like fibromyalgia find better and cheaper relief from massage than from costly drugs.


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With a combination of prudence and openmindedness, coverage for a reasonable range of alternative approaches might enhance patients’ outcomes and satisfaction without necessarily increasing health care costs.

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CONCLUSION This is a time of turbulent transition throughout health care. From within and from outside conventional medicine, traditions hitherto unquestioned are being challenged. And as millions of citizens are expected soon to enter the ranks of the insured, careful shepherding of common resources is imperative. While it is deeply unsettling for many people, wonderful opportunities are also emerging, in which medicine can be improved by its encounters with the strangers from outside, and perhaps even more so by examining its own most cherished assumptions.

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AC K N OW L E D G M E N T The author acknowledges with gratitude the very helpful comments provided on earlier drafts of this paper by Lawrence J. Schneiderman, M.D., Rosamond Rhodes, Ph.D., and Anita Silvers, Ph.D.

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Notes

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1. A lengthy but still incomplete list would include chiropractic, massage, exercise therapy such as Tai Chi or yoga, acupuncture, coining, cupping, homeopathy, naturopathy, herbal medicine, self-help groups, folk remedies, energy healing, relaxation techniques, guided imagery, therapeutic touch, spiritual or faith healing, nutrition and special diets such as macrobiotics or megavitamin therapy, biofeedback, hypnosis, folk remedies, root medicine, aromatherapy, reflexology, prayer, and purification ceremonies. 2. Eisenberg, D.M., R.C. Kessler, C. Foster, et al. (1993). Unconventional medicine in the United States. New England Journal of Medicine 328:246–252. 3. Eisenberg, D.M., R. B. Davis, S.L. Ettner, et al. (1998). Trends in alternative medicine use in the United States, 1990–1997. Journal of the American Medical Association 280:1569–1575. 4. Kessler, R.C., R.B. Davis, D.F. Foster, M.I. Van Rompay, E.E. Walters, S.A. Wilkey, T.J. Kaptchuk, & D.M. Eisenberg DM. (2001). Long-term trends in the use of complementary and alternative medical therapies in the United States. Annals of Internal Medicine 135:262–268; Chan, E. (2008). Quality of efficacy research in complementary and alternative medicine. Journal of the American Medical Association 299:2685– 2686; Druss, B.G., S.C. Marcus, M. Olfson, T. Tanielian, & H.A. Pincus. (2003). Trends in care by nonphysician clinicians in the United States. New England Journal of Medicine 348:130–137.

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5. Miller, F.G., E.J. Emanuel, D.I. Rosenstein, & S.E. Straus. (2004). Ethical issues concerning research in complementary and alternative medicine. Journal of the American Medical Association 291:599–604, at 599. 6. See below, “Addressing the Tensions.” 7. The state of Washington, for instance, has mandated that health plans cover some forms of alternative health care—a statute that its Supreme Court upheld. See WA Rev. Code § 48.43.045. For cases concerning this statute see Certification v. Regence Blue Shield, 991 P.2d 77 (WA 2000); Washington Physicians Services Ass’n v. Gregoire, 967 F.Supp. 424 (W.D. Wash. 1997). See also Grandinetti, D.A. (1997). “Integrated medicine” could boost your income. Medical Economics 74(8): 73–99, at 74; YaDeau, R. (1996). Cost-effectiveness and complementary medicine. American Journal of Managed Care 2:460; Grandinetti, D.A. (1999). Your newest competitors: alternative-medicine networks. Medical Economics 76(10):44–51. 8. Kaiser Family Foundation. Trends in Health Care Costs and Spending, March 2009; available at http://www.kff.org/insurance/upload/7692_02.pdf. 9. “Roughly a third of unconventional practices entail theories that are patently unscientific and in direct competition with conventional medicine.” Campion, E.W. (1993). Why unconventional medicine? New England Journal of Medicine 328:282–283, at 282. “It is time for the scientific community to stop giving alternative medicine a free ride. There cannot be two kinds of medicine—conventional and alternative. There is only medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work.” Angell, M., & J.P. Kassirer. (1998) Alternative medicine—the risks of untested and unregulated remedies. New England Journal of Medicine 339:839–841, at 841. 10. Eskinazi, D.P. (1998). Factors that shape alternative medicine. Journal of the American Medical Association 280:1621–1623, at 1621; see also Kaptchuk, T.J., & D.M. Eisenberg DM. (1998). The persuasive appeal of alternative medicine. Annals of Internal Medicine 129:1061–1065. 11. Kanigel, R. (1998). Taking acupuncture seriously. Hippocrates 12(5): 23–24, at 24. 12. “Most alternative systems of treatment are based on irrational or fanciful thinking and false or unproven factual claims. Their theories often violate basic scientific principles and are at odds not only with each other, but with current knowledge of the structure and function of the human body as now taught in our medical schools.” Relman, A.S. (1999). Is integrative medicine the medicine of the future? Archives of Internal Medicine 159:2122–2126, at 2123. Relman continues: “Alternative medicine stands apart from modern science, challenging many of its assumptions and methods and depending for its verification largely


on personal belief and subjective experience . . . alternative medicine teaches that faith in a method will make it effective and that the strongest kind of evidence is the patient’s belief that a treatment is working.” 13. Schneiderman, L.J. (2000). Alternative medicine or alternatives to medicine? A physician’s perspective. Cambridge Quarterly of Healthcare Ethics 9: 83–97, at 91. 14. Eskinazi summarizes the metaphysics of medical science:

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Biomedicine is founded in part on materialism (in contrast to the vital force explanation). Materialism in this context refers to the theory that “physical matter is the only or fundamental reality, and that all beings and processes and phenomena are manifestations or results of matter.” While biomedicine does not necessarily reject religion or spirituality, it does not routinely incorporate these aspects into diagnosis and treatment . . . . Consistent with this philosophical theory, biomedicine considers biological entities more or less as equal to the sum of their anatomic parts . . . and endeavors to elucidate molecular, physiological, and pathological mechanisms believed to form the basis of biological processes. Allopathic medical treatment often logically consists of interventions chosen to interfere with identified pathological molecular processes.

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Eskinazi, D.P. (1998). Factors that shape alternative medicine. Journal of the American Medical Association 280:1621–1623, at 1621–22. 15. Black M. (1967). Induction. In: Edwards P, editor-in-chief. The Encyclopedia of Philosophy. New York: Macmillan Publishing Co., vol. 4, pp. 169–181. 16. Angell, M., & J.P. Kassirer. (1998). Alternative medicine—the risks of untested and unregulated remedies. New England Journal of Medicine 339:839–841, at 839. See also Boozang, K.M. (1998). Western medicine opens the door to alternative medicine. American Journal of Law & Medicine 24:185–212, at 204, defining quackery as any treatment that:

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“a. is implausible on a priori grounds (because its implied mechanisms or putative effects contradict well-established laws, principles, or empirical findings in physics, chemistry or biology), b. lacks a scientifically acceptable rationale of its own, c. has insufficient supporting evidence from adequately controlled outcome research (i.e. double-blinded, randomized, placebo-controlled trials), or

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d. has failed in well-controlled studies done by impartial evaluators and has been unable to rule out competing explanations for why it might seem to work in uncontrolled settings.”

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17. As noted by Vandenbroucke and deCraen: “We should be grateful for debates about alternative medicine: They open our eyes to the nature of our reasoning in conventional medicine. We should forever keep an open mind, but, according to the late Petr Skrabanek, not so open that our brain falls out.” Vandenbroucke, J.P., & A.J.M. de Craen. (2001). Alternative medicine: a “mirror image” for scientific reasoning in conventional medicine. Annals of Internal Medicine 135:507–513, at 512. 18. “[H]omeopathic treatments are highly individualized and homeopaths do not comply with orthodox diagnostic criteria. This can create problems when conducting a standard randomized clinical trial.” Ernst, E., & T. Kaptchuk. (1996). Homeopathy revisited. Archives of Internal Medicine 156:2162–2164, at 2164. “Homeopaths often claim that modern trial methods are not applicable to homeopathy” and that “`controlled, randomized, double-blind studies have little significance with respect to homeopathic medical therapy.’” Id., at 2164. “[T]he efficacy of its therapies is intrinsically unmeasurable because therapy for every individual patient is, by definition, unique, an assumption that makes it difficult if not impossible to assemble meaningful study cohorts.” Davidoff, F. (1998). Weighing the alternatives: lessons from the paradoxes of alternative medicine. Annals of Internal Medicine 129:1068–1070, at 1069. 19. Margolin, A., S.K. Avants, & H.D. Kleber. (1998). Investigating alternative medicine therapies in randomized controlled trials. Journal of the American Medical Association 280:1626–1628. See also Shekelle, P.G., S.C. Morton, M.J. Suttorp, N. Buscemi, & C. Freisen. (2005). Challenges in systematic reviews of complementary and alternative medicine topics. Annals of Internal Medicine 142:1042–1047, at 1043. Traditional Chinese medicine does not have the concept of “placebo”, and it is difficult for practical as well as philosophical reasons even to construct a viable concept of “sham” insertion points for the needles. Moreover, within this approach there is no biochemical “marker” for active treatment, “nor is there one that would differentiate an active from a control treatment.” Id., at 1627. 20. Margolin, A., S.K. Avants, & H.D. Kleber. (1998). Investigating alternative medicine therapies in randomized controlled trials. Journal of the American Medical Association 280:1626–1628, at 1627–1628. 21. Kaptchuk, T.J., & D.M. Eisenberg. (1998). The persuasive appeal of alternative medicine. Annals of Internal Medicine 129:1061–1065. 22. For instance, we have little understanding about the nature of consciousness, of how it is that brain, or any other sort of matter, can have awareness. As suggested by one observer, “[n]obody has the slightest


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idea how anything material could be conscious.” Dossey, L. (2000). Prayer and medical science: a commentary on the prayer study by Harris et al and a response to critics. Archives of Internal Medicine 160:1735–1738, citing philosopher Jerry A. Fodor, at p. 1736. Science remains similarly puzzled over other mental/physical issues, such as evidence indicating that psychokinesis—the apparent ability of a human mind to affect physical events at a distance—may be a bona fide phenomenon.

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“For example, in Foundations of Physics, one of physics’ most prestigious journals, Radin and Nelson reported a meta-analysis of 832 studies from 68 investigators that involved the distant influence of human consciousness on microelectronic systems. They found the results to be ‘robust and repeatable.’ In their opinion, . . . ‘there is no escaping the conclusion that [these] effects are indeed possible.’ While these hundreds of studies do not involve actual prayer, they nonetheless deal with whether human intention can, in principle, affect the physical world at a distance. In recent years, researchers have also studied the effects of mental efforts to change biological systems. Scores of controlled studies have examined the effects of intentions, often expressed through prayer, on biochemical reactions in vitro, on the recovery rate of animals from anesthesia, on the growth rates of tumors and the rate of wound healing in animals, on the rate of hemolysis of red blood cells in vitro, and on the replication rates of microorganisms in test tubes. Testing prayer in lower organisms makes sense for the same reason we test drugs in nonhumans. We share physioloogical similarities with animals and bacteria; if prayer affects them, it may affect us as well.”

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Dossey, L. (2000). Prayer and medical science: a commentary on the prayer study by Harris et al and a response to critics. Archives of Internal Medicine 160: 1735–1738, at 1735. 23. For discussion of the difficulties in measuring quality of life, see, e.g., Morreim, E.H. (1992). The impossibility and the necessity of quality of life research. Bioethics 6(3):218–232; Leplege, A., & S. Hunt. (1997). The problem of quality of life in medicine. Journal of the American Medical Association 278:47–50; Morreim, E.H. (1995). Quality of life in health care allocation. In: Encyclopedia of Bioethics, 2nd ed., ed. W.T. Reich. New York: Simon & Schuster MacMillan, Volume 3, pp. 1358–1361; Morreim, E.H. (1986). Computing the quality of life. In: The Price of Health: Cost Benefit Analysis in Medicine, eds. G. Agich & C. Begley. Dordrecht: D. Reidel Pub. Co, pp. 45–69; Testa, M.A., & D.C. Simonson. (1996). Assessment of quality-of-life outcomes. New England Journal of Medicine 334:835– 840; Coates, A., V. Gebski, J.F. Bishop, et al. for the Australian-New Zealand Breast Cancer Trials Group,

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Clinical Oncological Society of Australia. (1987). Improving the quality of life during chemotherapy for advanced breast cancer. A comparison of intermittent and continuous treatment strategies. New England Journal of Medicine 317:1490–1495; Gill, T.M., & A.R. Feinstein. (1994). A critical appraisal of the quality of quality-of-life measurements. Journal of the American Medical Association 272:619–626; Lehman, A.F. (1995). Measuring quality of life in a reformed health system. Health Affairs 14(3):90–101; Smith, A. (1987). Qualms and QALY’s. Lancet 1987; May 16: 1134–1136; Guyatt, G.H., D.H. Feeny, & D.L. Patrick. (1993). Measuring health-related quality of life. Annals of Internal Medicine 118:622–629; LaPuma, J., & E.F. Lawlor. (1990). Quality-adjusted life-years: Ethical implications for physicians and policymakers. Journal of the American Medical Association 263:2917–2921. 24. “The record of medical treatments is largely the chronicle of placebos. When subjected to scrutiny, the overwhelming majority of treatments, old and new, turn out to have no inherent therapeutic activity. And it is worth remembering that treatments now known to be of questionable value, from bloodletting to routine tonsillectomy, rested on compelling theories. Each theory may have been invalid, even wacky, but it made sense at the time. . . . But placebo treatment is not the same as no therapy. Studies have shown that although up to 70 percent of depressed patients improve after taking a placebo, depressed patients rarely improve while awaiting treatment. And in a placebo-controlled study assessing propranolol’s effect on mortality in myocardial infarction survivors, patients who took a placebo regularly (more than 75 percent of the prescribed dose) had half the mortality rate of those who took it less steadily. Finally, a recent study showed that people with schizophrenia who took placebos were less likely to relapse than those who didn’t receive any treatment.” Brown, W.A. (1998). The power of the placebo. Hippocrates 12(6):47–52, at 48–49. See also Jaret, P. (1997). The mind has the power to heal. Hippocrates 11(5):71–77. See also Horwitz, R.I., & S.M. Horwitz. (1993). Adherence to treatment and health outcomes. Archives of Internal Medicine 153:1863–1868; Brody, H. (1980). Placebos and the Philosophy of Medicine. Chicago: University of Chicago Press. 25. By one study of antidepressant medications, the placebo response in 2005 appears to be twice as powerful as it was in 1980. Spiegel, A. (March 8, 2010). The Growing Power of the Sugar Pill. National Public Radio; available at http://www.npr.org/templates/story/story. php?storyId=124367058; Stolk, P., M. ten Berg, M.E.H. Hemes, & T.R. Einarson. (2003). Meta-analysis of placebo rates in major depressive disorder trials. Annals of Pharmacotherapy 37:1891–1899.


26. A further purpose of blinding is also to minimize the chance that the perceptions and the reports of scientists and of research subjects will be shaded by the goals they hold for participating in the research. 27. Sullivan, M.D. (1993). Placebo controls and epistemic control in orthodox medicine. Journal of Medicine and Philosophy 18:213–231, at 223–225. 28. Schneiderman, L.J. (2000). Alternative medicine or alternatives to medicine? A physician’s perspective. Cambridge Quarterly of Healthcare Ethics 9:83–97, at 94. 29. Angell, M. (1984). Patients’ preferences in randomized clinical trials. New England Journal of Medicine 310:1385–1387. 30. Miller, F.G. (2003). Sham surgery: an ethical analysis. American Journal of Bioethics 3(4):41–48; Macklin, R. (1999). The ethical problems with sham surgery in clinical research. New England Journal of Medicine 341:992–996. 31. Merkatz, R.B., R. Temple, S. Sobel, et al. (1993). Women in clinical trials of new drugs. New England Journal of Medicine 329:292–296; Bennett, J.C. (1993). Inclusion of women in clinical trials—policies for population subgroups. New England Journal of Medicine 329:288–292; Freeman, T.B., D.E. Vawter, P.E. Leaverton, et al. (1999). Use of placebo surgery in controlled trials of a cellular-based therapy for Parkinson’s disease. New England Journal of Medicine 341:988–992; Macklin, R. (1999). The ethical problems with sham surgery in clinical research. New England Journal of Medicine 341:992–996. 32. Freeman, T.B., D.E. Vawter, P.E. Leaverton, et al. (1999). Use of placebo surgery in controlled trials of a cellular-based therapy for Parkinson’s disease. New England Journal of Medicine 341:988–992; Macklin, R. (1999). The ethical problems with sham surgery in clinical research. New England Journal of Medicine 341:992–996. 33. The manufacturer of a costly new drug for arthritis is hardly likely, for instance, to do a scientific comparison between its products and copper bracelets. Even a remote possibility of finding such an inexpensive remedy to be effective is enough to discourage such a study from being undertaken. And because copper is so inexpensive, the bracelet manufacturers can’t make enough profit to justify the expense of the research—particularly since they are not required to do any science so long as they make no health claims. Indeed, science is not merely unlikely in such scenarios. History has shown that sometimes even when high-quality scientific trials have been done, their results may not see the light of day if they are unfavorable to the study’s sponsor. See Rennie, D. (1997). Thyroid storm. Journal of the American Medical Association 277:1238–1243. 34. Garas, I., & A.J. Manolis. (1999). The economics of therapeutic advances: the paradigm of sympathetic

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suppression in chronic heart failure. Archives of Internal Medicine 2634–2636, at 2635. Others have likewise observed that inexpensive, effective therapies tend to be ignored. See Goodwin, J.S., & J.M. Goodwin. (1984). The tomato effect: rejection of highly efficacious therapies. Journal of the American Medical Association 251: 2387–2390; Goodwin, J.S., & J.M. Goodwin. (1981). Failure to recognize efficacious therapy: the history of aspirin treatment for rheumatoid arthritis. Perspectives in Biology & Medicine 25:78–92; Lederle, F.A., W.A. Applegate, & R.H. Grimm, Jr. (1993). Reserpine and the medical marketplace. Archives of Internal Medicine 153:705–706. 35. As noted by Feinstein, clinical research, as opposed to basic science and laboratory research, has long been looked down upon as being somehow inferior “applied” work. As a result, until recently funding has focused mainly on the latter and not on the former. Feinstein, A.R. (1994). Clinical judgment revisited: the distraction of quantitative methods. Annals of Internal Medicine 1230:799–805. And as noted by other commentators, those who use guidelines “cannot help but notice that guideline developers must often reckon with research that is modest in rigor, discordant, or nonexistent. Although most guidelines are an amalgam of evidence and expert opinion, methods of integrating knowledge and experience into guidelines, particularly when data are sparse, are neither as mature nor as transparent as methods of incorporating research results.” Cook, D., & M. Giacomini. (1999). The trials and tribulations of clinical practice guidelines. Journal of the American Medical Association 281:1950–1951, at 1950. 36. Dalen, J.E. (1998). “Conventional” and “unconventional” medicine. Archives of Internal Medicine 158:2179–2181, at 2179. 37. Dalen, J.E. (1998). “Conventional” and “unconventional” medicine. Archives of Internal Medicine 158:2179–2181, at 2180. 38. Berwick, D.M. (1996). We can cut costs and improve care at the same time. Medical Economics 73(15):180–187, at 186. 39. Relman, A.S., & A. Weil. (1999). Is integrative medicine the medicine of the future? Archives of Internal Medicine 159:2122–2126, at 2125. Another estimate puts the figure even lower. “Richard Smith, editor of the British Medical Journal, [states that] ‘only about 15% of medical interventions are supported by solid scientific evidence. . . . This is partly because only 1% of the articles in medical journals are scientifically sound and partly because many treatments have not been assessed at all.’” Dossey, L. (2000). Prayer and medical science: a commentary on the prayer study by Harris et al and a response to critics. Archives of Internal Medicine 160:1735–1738, at 1736.


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40. Committee on Quality of Health Care in America, Institute of Medicine. (2001). Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academy Press, at p. 13 (citing E.A. Balas & S.A. Boren. [2000]. Managing Clinical Knowledge for Health Care Improvement. Yearbook of Medical Informatics. National Library of Medicine, Bethesda, MD, pp. 65–70). 41. In scientific research, evaluation of diseases and treatments “generally requires a priori hypotheses, randomization (to eliminate selection bias and confounding), homogeneous patients at high risk for the outcome, experienced investigators who follow a protocol, a comparative measure such as a placebo (if ethical), and intensive follow-up to ensure compliance. Under these circumstances, if a treatment proves to be better than a placebo (or a comparative measure), one can be reassured that the treatment can work. However, questions may remain about the ability of the treatment to work adequately in a broader range of patients and in usual practice settings in which both patients and providers face natural barriers to care.” Epstein, R.S., & L.M. Sherwood. (1996). From outcomes research to disease management: a guide for the perplexed. Annals of Internal Medicine 124:832–837, at 833. See also Feinstein, A.R., & R.I. Horwitz. (1997). Problems in the “evidence” of “evidence-based medicine.” American Journal of Medicine 103:529–535; Wells, K.B., & R. Sturm. (1995). Care for depression in a changing environment. Health Affairs 14(3):78–89, at 80. “Clinical trials are not real life. To assess efficacy in as unconfounded a manner as possible, trials sometimes exclude certain patients (e.g., the elderly, the very young, those too sick, or those taking certain other medications). Any special vulnerability to adverse events in those groups will be missed.” Friedman, M.A., J. Woodcock, M.M. Lumpkin, J.E. Shuren, A.E. Hass, & L.J. Thompson. (1999). The safety of newly approved medicines: do recent market removals mean there is a problem? Journal of the American Medical Association 281:1728–1734, at 1733. 42. Epstein, R.S., & L.M. Sherwood. (1996). From outcomes research to disease management: a guide for the perplexed. Annals of Internal Medicine 124:832–837. “The failure to account for the effects of comorbid and associated conditions on the clinical outcome of chronic diseases is reflected in the common disjunction that occurs between the efficacy of an intervention, such as a drug used in a clinical trial, and the lack of effectiveness of the same drug used in clinical practice. For example, as many as 60% to 80% of patients with heart failure have been excluded from clinical trials of angiotensin-converting enzyme inhibitor therapy owing to comorbid and associated conditions that tend to obscure the efficacy of the drug in improving functional capacity or prognosis.

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This standard practice in research has a rational basis. However, the clinician must treat 100% of the patients with heart failure, not just the 20% to 40% who are free of comorbidities and associated conditions. Moreover, the clinical effectiveness of drug therapy is often limited by the very comorbid and associated conditions for which patients were excluded from drug trials.”

DeBusk, R.F., J.A. West, N.H. Miller, & C.B. Taylor. (1999). Chronic disease management. Archives of Internal Medicine 159:2739–2742, at 2740. Regarding coronary bypass surgery, Gellins et al. observed that “only 4 to 13 percent of the patients who now undergo this operation would meet the eligibility criteria for the randomized controlled trials that established its efficacy.” Gellins, A.C., N. Rosenberg, & A.J. Moskowitz. (1998). Capturing the unexpected benefits of medical research. New England Journal of Medicine 339:693–697, at 694. See also Feinstein, A.R. (1994). Clinical judgment revisited: the distraction of quantitative methods. Annals of Internal Medicine 1230:799–805. 43. Friedman, M.A., J. Woodcock, M.M. Lumpkin, J.E. Shuren, A.E. Hass, & L.J. Thompson. (1999). The safety of newly approved medicines: do recent market removals mean there is a problem? Journal of the American Medical Association 281:1728–1734, at 1729. 44. Zugar, A. (1998). New way of doctoring: going by the evidence. Physician’s Management 38(2):41–44, at 42. As Eisenberg notes, “there is sufficient evidence to suggest that most clinicians’ practices do not reflect the principles of evidence-based medicine but rather are based upon tradition, their most recent experience, what they learned years ago in medical school, or what they have heard from their friends.” Eisenberg, J.M. (2001). What does evidence mean? Can the law and medicine be reconciled? Journal of Health Policy, Politics & Law 26:369–381. See also Mold, J.W., & H.F. Stein. (1986). The cascade effect in the clinical care of patients. New England Journal of Medicine 314:512–514; Fisher, E.S., & H.G. Welch. (1999). Avoiding the unintended consequences of growth in medical care. How might more be worse? Journal of the American Medical Association 281:446– 453; Franks, P., C.M. Clancy, & P.A. Nutting. (1992). Gatekeeping revisited—protecting patients from overtreatment. New England Journal of Medicine 327:424– 429; Burnum, J.F. (1987). Medical practice a la mode. New England Journal of Medicine 317:1220–1222; Hardison, J.E. (1979). To be complete. New England Journal of Medicine 300:193–194. 45. Hall, J.B. (2000). Use of the pulmonary artery catheter in critically ill patients: was invention the mother of necessity? Journal of the American Medical Association 283:2577–2578; Rapoport, J., D. Teres, J. Steingrub, T. Higgins, W. McGee, & S. Lemeshow S.


(2000). Patient characteristics and ICU organizational factors that influence frequency of pulmonary artery catheterization. Journal of the American Medical Association 283:2559–2567; Bernard, G.R., G. Sopko, F. Cerra, R. Demling, et al. (2000). Pulmonary artery catheterization and clinical outcomes: NHLBI and FDA workshop report. Journal of the American Medical Association 283:2568–2572. 46. ECRI. High-dose chemotherapy with autologous bone marrow transplantation and/or blood cell transplantation for the treatment of metastatic breast cancer. Healthy Technology Assessment Information Service: Executive Briefings, February 1995. 47. Stadtmauer, E.A., A. O’Neill, L.J. Goldstein, et al. (2000). Conventional-dose chemotherapy compared with high-dose chemotherapy plus autologous hematopoietic stem-cell transplantation for metastatic breast cancer. New England Journal of Medicine 342: 1069–1076; Lippman, M.E. (2000). High-dose chemotherapy plus autologous bone marrow transplantation for metastatic breast cancer. New England Journal of Medicine 342:1119–1120. 48. For example, Roberts et al.

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“carefully examined the data obtained from open studies at a time when they were considered highly effective by the patients as well as their physicians. They analyzed the use of glomectomies as a treatment for asthma, levamisole as an immunomodulator, photodynamic therapy and organic solvents for herpes simplex infection, and gastric freezing for ulcers. Seventy percent of the almost 7000 patients who participated in these open studies in the 1960s and early 1970s were found to have obtained good to excellent results from these modalities. This report shows that belief and expectancy of patients, and especially of their health care providers, played a critical role in determining the effectiveness of treatments later found to be nonspecific by scientific measures.”

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Tausk, F.A. (1998). Alternative medicine: is it all in your mind? Archives of Dermatology 134:1422–1425, at 1423 (citing A.H. Roberts, D.B. Kewman, L. Mercier, & M. Hovell. [1993]. The power of nonspecific effects in healing: implications for psychosocial and biological treatments. Clinical Psychology Review 13:375–391). 49. Though physician practices vary relatively little in situations where strong consensus guides practice, as in the treatment of hip fractures, in areas where there is little consensus, practices vary widely, in ways not correlated with differences in patients’ condition.

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“The recent Dartmouth Atlas details less than a 2-fold variation in the treatment of hip fractures—30% higher than the national average to 25% below the average—most likely because there is strong evidence about the most effective interventions, and the medical community agrees on this evidence. . . . On the other hand, Wennberg also found an almost 6-fold variation in the rates of carotid

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duplex diagnostic procedures, from 20 to more than 115 per 1000 Medicare enrollees, due largely to ‘no consensus among physicians about which patients should be screened with carotid duplex.’ In another example, there was a 5.5-fold variation in the use of coronary angiography, from 9.6 to 53.1 per 1000 Medicare enrollees, because ‘physicians disagree about how severe patients’ symptoms must be to warrant’ its use.”

Eisenberg, J.M. (1999). Ten lessons for evidencebased technology assessment. Journal of the American Medical Association 282:1865–1869, at 1866. See Wennberg, J.E. (1986). Which rate is right? New England Journal of Medicine 314:310–311; Chassin, M.R., R.H. Brook, R.E. Park, et al. (1986). Variations in the use of medical and surgical services by the Medicare population. New England Journal of Medicine 314:285– 290; Wennberg, J.E., J.L. Freeman, & W.J. Culp. (1987). Are hospital services rationed in New Haven or overutilized in Boston? Lancet 1:1185–1188; Welch, H.G., Miller, M.E., & Welch, W.P. (1994). An analysis of inpatient practice patterns in Florida and Oregon. New England Journal of Medicine 330:607–612; Wennberg, J.E. (1987).The paradox of appropriate care. Journal of the American Medical Association 258:2568–2569; Chassin, M.R., et al. (1987). Does inappropriate use explain geographic variations in the use of health care services? Journal of the American Medical Association 258:2533–2537; Wennberg, J.E. (1990). Outcomes research, cost containment, and the fear of rationing. New England Journal of Medicine 323:1202–1204; Leape, L.L., R.E. Park, D.H. Solomon, et al. (1990). Does inappropriate use explain small-area variations in the use of health care services? Journal of the American Medical Association 263:669–672; Leape, L.L., R.E. Park, D.H. Solomon, et al. (1989). Relation between surgeons’ practice volumes and geographic variation in the rate of carotid endarterectomy. New England Journal of Medicine 321:653–657; Wennberg, J.E. (1991). Unwanted variations in the rule of practice. Journal of the American Medical Association 265:1306– 1307; Cleary, P.D., S. Greenfield, A.G. Mulley, et al. (1991). Variations in length of stay and outcomes for six medical and surgical conditions in Massachusetts and California. Journal of the American Medical Association 266:73–79; Fisher, E.S., H.G. Welch, & J.E. Wennberg. (1992). Prioritizing Oregon’s hospital resources: An example based on variations in discretionary medical utilization. Journal of the American Medical Association 267:1925–1931; Greenfield, S., E.C. Nelson, M. Subkoff M, et al. (1992). Variations in resource utilization among medical specialties and systems of care: Results from the medical outcomes study. Journal of the American Medical Association 267:1624– 1630; Welch, W.P., M.E. Miller, H.G. Welch, et al. (1993). Geographic variation in expenditures for physicians’ services in the United States. New England


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Journal of Medicine 328:621–627; Miller, M.G., L.S. Miller, B. Fireman, & S.B. Black. (1994). Variation in practice for discretionary admissions. Journal of the American Medical Association 271:1493–1498; Detsky, A.S. (1995). Regional variation in medical care. New England Journal of Medicine 333:589–590; Guadagnoli, E., P.J. Hauptman, J.Z. Avanian, et al. (1995). Variation in the use of cardiac procedures after acute myocardial infarction. New England Journal of Medicine 333: 573–578; Pilote, L., R.M. Califf, S. Sapp, et al. for the GUSTO-1 Investigators. (1995). Regional variation across the United States in the management of acute myocardial infarction. New England Journal of Medicine 333:565–572; Ashton, C.M., N.J. Petersen, J. Souchek, et al. (1999). Geographic variations in utilization rates in Veterans Affairs hospitals and clinics. New England Journal of Medicine 340:32–39; O’Connor, G.T., H.B. Quinton, N.D. Traven, et al. (1999). Geographic variation in the treatment of acute myocardial infraction: the cooperative cardiovascular project. Journal of the American Medical Association 281:627–633; Wennberg, J.E. (1999). Understanding geographic variations in health care delivery. New England Journal of Medicine 340:52–53. 50. For an extensive discussion of the ways in which actual clinical practices can constitute overuse, underuse, and misuse of available diagnostic and therapeutic interventions, see Morreim, E.H. (1999). Playing doctor: corporate medical practice and medical malpractice. Michigan Journal of Law Reform 32(4):939– 1040, at 989–998. See also Chassin, M.R., R.W. Galvin, National Roundtable on Health Care Quality. (1998). The urgent need to improve health care quality. Journal of the American Medical Association 280:1000–1005; Bodenheimer, T. (1999). The American health care system: the movement for improved quality in health care. New England Journal of Medicine 340:488–492; Chassin, M.R. (1998). Is health care ready for Six Sigma quality? Milbank Quarterly 76(4):565–591. 51. In some cases clinicians point out, quite correctly, that the guidelines imposed by health plans sometimes have a very poor scientific basis. And yet other times the protests, based on an insistence that “every patient is individual” and “my patients are different,” amount to a claim that clinical medicine cannot be scientific in any thoroughgoing way. The clinical physician begins to resemble his rival providers in the alternatives. 52. For further discussion on the limits of guidelines’ scientific basis, see Morreim, E.H. (1999). Playing doctor: corporate medical practice and medical malpractice. Michigan Journal of Law Reform 32(4):939– 1040, at 981–989. 53. “[M]ainstream medicine can be criticized for overselling its own scientific legitimacy. ‘It’s reasonable to say that much of existing medicine has not met the

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standards that alternative medicine is being asked to meet.’” Brown, C. (1995). Alternative medicine comes to the OR. Medical Economics 72(17):207–219, at 218–219. 54. As one commentator observed, one view holds that everything that makes an individual an individual is outside of science. This is the art of medicine. However, as an alternate view has noted: “`Art kills. It was the art that gave us purging, puking, leeches, the gastric freeze, all that sort of stuff. There’s a science to the art of medicine.’” Zugar, A. (1998). New way of doctoring: going by the evidence. Physician’s Management 38(2):41–44, at 44. 55. Accordingly, the scorn that sometimes marks medicine’s appraisals of alternative approaches should be avoided. In a variety of instances, derision has been used as a weapon where better-quality arguments are unavailable. Through the 1950s, 1960s, and 1970s, for instance, standard medical textbooks like Harrison’s and Cecil’s treated vitamin therapy with a scornful, dismissive tone, using terms like “massive,” “carelessness,” “useless,” “indiscriminate,” “false,” “indefensible,” “wasteful,” “insidious,” “unnecessary,” “deplored.” Goodwin, J.S., & M.R. Tangum. (1998). Battling quackery: attitudes about micronutrient supplements in American academic medicine. Archives of Internal Medicine 158:2187–2191. Similarly, in the mid-1980s, one article in the New England Journal of Medicine scoffed at the notion of “antioxidants” (Gillick, M.R. [1985]. Common-sense models of health and disease. New England Journal of Medicine 313: 700–703), while another in the same journal pronounced dead the idea that human emotions have a causal role in illness. “[I]t is time to acknowledge that our belief in disease as a direct reflection of mental state is largely folklore.” Angell, M. (1985). Disease as a reflection of the psyche. New England Journal of Medicine 312:1570–1572, at 1572. Subsequent research findings have challenged such dismissals with considerable force. “[O]ne should remain humble about physicians’ own mixture of art and science. Not so long ago, leeches and frozen stomachs were in their domain, and many of their beliefs today must remain tentative.” Delbanco, T.L. (1994). Bitter herbs: mainstream, magic, and menace. Annals of Internal Medicine 121:803–804, at 804. 56. As noted by Paul Starr, medicine’s dominance of the health-care market is also a political phenomenon. Starr, P. (1982). The Social Transformation of American Medicine. New York: Basic Books. 57. Lazarou, J., B.H. Pomeranz, & P.N. Corey. (1998). Incidence of adverse drug reactions in hospitalized patients. Journal of the American Medical Association 279:1200–1205. 58. Institute of Medicine. (1999). To Err is Human: Building a Safer Health System. Washington DC: National Academy Press.


59. Coppes, J.M., R.A. Anderson, R.M. Egeler, & J.E.A. Wolff. (1998). Alternative therapies for treatment of childhood cancer [letter]. New England Journal of Medicine 339:846; Ko, R.J. (1998). Adulterants in Asian patent medicines [letter]. New England Journal of Medicine 339:847; LoVecchio, F., S.C. Curry, & T. Bagnasco. (1998). Butyrolactone-induced central nervous system depression after ingestion of RenewTrient, a “dietary supplement” [letter]. New England Journal of Medicine 339:847–848; Angell, M., & J.P. Kassirer. (1998). Alternative medicine—the risks of untested and unregulated remedies. New England Journal of Medicine 339:839–41; Winslow, L.C., & D.J. Kroll. (1998). Herbs as medicines. Archives of Internal Medicine 158:2192–2199. 60. See supra note 1. 61. Eisenberg, D.M., R.B. Davis, S.L. Ettner, et al. (1998). Trends in alternative medicine use in the United States, 1990–1997. Journal of the American Medical Association 280:1569–1575. 62. In 1990, the estimated total expenditure for alternatives was $13.7 billion, of which $10.3 billion was out of pocket. Eisenberg, D.M., R.C. Kessler, C. Foster, et al. (1993). Unconventional medicine in the United States. New England Journal of Medicine 328:246–252. 63. In the very different case of children, mandates for medicine can indeed be appropriate in cases where the illness or injury is life-threatening, and the ability of medical treatment to help is clear and substantial. Issues regarding children and alternative treatments would take this essay too far afield, however, and will thus at this point be left for another forum. 64. In recent studies, alternative treatments were mainly used for chronic conditions such as back problems, headache, anxiety, and depression. Eisenberg, D.M., R.B. Davis, S.L. Ettner, et al. (1998). Trends in alternative medicine use in the United States, 1990– 1997. Journal of the American Medical Association 280:1569–1575; Campion, E.W. (1993). Why unconventional medicine? New England Journal of Medicine 328:282–283; Eisenberg, D.M., R.C. Kessler, C. Foster, et al. (1993). Unconventional medicine in the United States. New England Journal of Medicine 328:246–252. 65. Exceptions can be made if some particular alternative were shown to be clearly, seriously harmful and without redeeming benefit—just as some drugs are removed from the market when their risks are determined to exceed their potential benefits. 66. Voelker, R. (2005). IOM points to need for more research, regulation in alternative medicine. Journal of the American Medical Association 293: 1178–1180. 67. Chan, E. (2008). Quality of efficacy research in complementary and alternative medicine. Journal of the American Medical Association 299:2685–2686.

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Moral justice and legal justice in managed care: the ascent of contributive justice. Journal of Law, Medicine, and Ethics 23(3):247–265; Morreim, E.H. (1995). Diverse and perverse incentives in managed care; bringing the patient into alignment. Widener Law Symposium Journal 1(1):89–139; Morreim, E.H. (2000). Saving lives, spending money: shepherding the role of technology. In: Ethical Issues in Health Care on the Frontiers of the Twenty-First Century, eds. S. Wear, J.J. Bono, G. Logue, & A. McEvoy; Philosophy and Medicine Series; Dordrecht: Kluwer Academic Publishers, pp. 63–110; Havighurst, C.C. (1995). Health Care Choices: Private Contracts as Instruments of Health Reform. Washington, DC: The AEI Press; Kalb, P.E. (1990). Controlling health care costs by controlling technology: a private contractual approach. Yale Law Journal 99:1109–1126; Hall, M.A., & G.F. Anderson. (1992). Health insurers’ assessment of medical necessity. University of Pennsylvania Law Review 140:1637– 1712, at 1689–1693. 96. Morreim, E.H. (2006). Consumer-defined health plans: Emerging challenges from tort and contract. Journal of Health Law 39(3):307–348; Morreim, E.H. (1994). Redefining quality by reassigning responsibility. American Journal of Law and Medicine 20(1– 2):79–104; Morreim, E.H. (1995). Diverse and perverse incentives in managed care; bringing the patient into alignment. Widener Law Symposium Journal 1(1):89– 139; Morreim, E.H. (2000). Saving lives, spending money: shepherding the role of technology. In: Ethical Issues in Health Care on the Frontiers of the TwentyFirst Century, eds. S. Wear, J.J. Bono, G. Logue, & A. McEvoy; Philosophy and Medicine Series; Dordrecht: Kluwer Academic Publishers, pp. 63–110. 97. Morreim, E.H. (1995). Diverse and perverse incentives in managed care; bringing the patient into alignment. Widener Law Symposium Journal 1(1):89–139.

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Limits of Science and Boundaries of Access

Limits of Science and Boundaries of Access

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