Unhealthy Politics: The Battle over Evidence-based Medicine - Rilegato

Patashnik, Eric M.; Gerber, Alan S.; Dowling, Conor M.

Rilegato

ISBN 10: 0691158819 ISBN 13: 9780691158815

Casa editrice: Princeton Univ Pr, 2017

Riassunto

How partisanship, polarization, and medical authority stand in the way of evidence-based medicine

The U.S. medical system is touted as the most advanced in the world, yet many common treatments are not based on sound science. Treatments can go into widespread use before they are rigorously evaluated, and every year patients are harmed because they receive too many procedures—and too few treatments that really work. Unhealthy Politics sheds new light on why the government’s response to this troubling situation has been so inadequate, and why efforts to improve the evidence base of U.S. medicine continue to cause so much political controversy and public trepidation.

This critically important book draws on public opinion surveys, physician surveys, case studies, and political science models to explain how political incentives, polarization, and the misuse of professional authority have undermined efforts to tackle the medical evidence problem and curb wasteful spending. It paints a portrait of a medical industry with vast influence over which procedures and treatments get adopted, and a public burdened by the rising costs of health care yet fearful of going against “doctor’s orders.” The book shows how the government’s efforts to promote evidence-based medicine have become mired in partisan debates. It also proposes sensible solutions that can lead to better, more efficient health care for all of us.

Unhealthy Politics offers vital insights not only into health policy but also into the limits of science, expertise, and professionalism as political foundations for pragmatic problem solving in American democracy.

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Informazioni sull?autore

Eric M. Patashnik is the Julis-Rabinowitz Professor of Public Policy and Political Science at Brown University. His books include Reforms at Risk (Princeton). Alan S. Gerber is the Charles C. and Dorathea S. Dilley Professor of Political Science at Yale University. His books include Field Experiments. Conor M. Dowling is associate professor of political science at the University of Mississippi. He is the coauthor of Super PAC!

Dalla quarta di copertina

"If you want to know why we're so lousy at avoiding wasteful, expensive care in the United States, read Unhealthy Politics. It’s an invaluable resource for understanding why commonsense solutions get mired in political controversy—and how we might get out of the partisan rut we’re in."--Nicholas Bagley, University of Michigan Law School

"Why is American health care so wasteful? In a masterstroke of political economy, Patashnik, Gerber, and Dowling show that it is not just that every treatment has its own constituency, but also that the political coalition for evidence-based treatment is weak, publicly doubted, corroded by partisanship, and includes few doctors. Following their advice might save us hundreds of billions."--Daniel Carpenter, Harvard University, author of Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA

"A searing indictment of American medicine and health-care policy. Unhealthy Politics is a provocative, compelling exploration of the dismal state of evidence-based medicine in the United States. Original, persuasive, and essential reading."--Jonathan Oberlander, author of The Political Life of Medicare

"Much of the $3 trillion America spends on health care is expended on care of little demonstrated value. At the same time, much care proven to genuinely work is not reliably delivered to the patients who need it most. In principle, comparative effectiveness research (CER) provides tools to do better. Yet in matters large and small, physicians, politicians, and the American public itself combine to oppose the use of rigorous clinical evidence to guide medical care. Eric Patashnik, Alan Gerber, and Conor Dowling straddle the boundaries of political science and policy analysis to explore why this is so. This is a magnificent book. It will be read for years to come."--Harold Pollack, University of Chicago

"With U.S. health care in critical condition, we as Americans must ask: How did we get here? In Unhealthy Politics, Patashnik, Gerber, and Dowling provide a convincing explanation as they illuminate and guide the reader through the labyrinth of current health policy."--Jonathan S. Skinner, Dartmouth College

"If you want to know why we're so lousy at avoiding wasteful, expensive care in the United States, read Unhealthy Politics. It’s an invaluable resource for understanding why commonsense solutions get mired in political controversy--and how we might get out of the partisan rut we’re in."--Nicholas Bagley, University of Michigan Law School

"Unhealthy Politics sheds light on the political forces that have limited the development of a better evidence base for health care in the United States. The book is beautifully written, succinct, and addresses an important topic. It will be widely read."--Michael K. Gusmano, coauthor of Health Care in World Cities

"Unhealthy Politics brings together numerous insights from political science along with new empirical evidence to shed light on one of the most important debates in health-care policy in the United States—the issue of how to produce better evidence to guide decisions about medical care. The book is timely, given rising health-care costs and increasing polarization about the role the state might play in addressing them. An informative and stimulating read."--Ann Campbell Keller, author of Science in Environmental Policy

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Unhealthy Politics

The Battle over Evidence-Based Medicine

By Eric M. Patashnik, Alan S. Gerber, Conor M. Dowling

PRINCETON UNIVERSITY PRESS

Copyright © 2017 Princeton University Press
All rights reserved.

ISBN: 978-0-691-15881-5

Contents

List of Figures and Tables, vii, 
Acknowledgments, xi, 
Introduction, 1, 
1 The Medical Guesswork Problem, 21, 
2 Sham Surgery: A Case Study of the Use of Medical Evidence, 37, 
3 Doctor Knows Best: The Influence of Physician Leadership on Public Opinion, 60, 
4 The Limits of Professional Self-Regulation: Findings from a National Physician Survey, 79, 
5 Zero-Credit Politics: The Government's Sluggish Effort to Promote Evidence-Based Medicine, 1970s–2008, 110, 
6 Electoral Competition, Polarization, and the Breakdown of Elite-Led Social Learning, 142, 
Conclusion: Postenactment Coalition Building (and Other Strategies for Sustaining Reform in a Polarized Age), 161, 
Appendixes, 181, 
Notes, 197, 
Bibliography, 225, 
Index, 255, 

CHAPTER 1

The Medical Guesswork Problem

The Centers for Disease Control (CDC), headquartered in Atlanta, is a national treasure. Staffed by a cadre of highly trained, dedicated professionals, the CDC protects the nation against dangerous health threats by detecting new germs as they spread around the globe, uncovering the most effective ways to combat disease, and disseminating new knowledge to physicians, policy makers and communities. The CDC sits alongside other crown jewels of America's medical system, including top private and nonprofit hospitals across the nation, such as Sloan Kettering. It is no wonder that the dominant impression is that the quality of American medical care is the best in the world — "a utopia of high-tech treatments, cutting-edge research, and expeditious and effective interventions."

The best American medicine is indeed excellent, and the nation is unambiguously a world leader in some areas. Yet much of the care that patients receive is not particularly effective for their clinical conditions. Moreover, the United States spends dramatically more per capita on medical care than do other advanced democracies and does not consistently outperform peers on quality measures or health outcomes.

For reasons that remain unclear, health care cost growth has moderated since 2002. Some experts suggest that possible explanations include "the rise in high- deductible insurance plans, state-level efforts to control Medicaid costs, and a general slowdown in the diffusion of new technology, particularly in the Medicare population." Yet health care costs are projected to grow at GDP plus 1.2 percent over the next twenty years, a rate high enough to cause serious pain for taxpayers and workers.

As figure 1.1 shows, in 2013 per capita spending on medical care in the United States (including out of pocket costs, insurance payments, and taxes to pay for health programs like Medicare) was $8,617 — nearly double the Organisation for Economic Co-operation and Development (OECD) average. The United States is wealthier than other nations, so it would be expected to spend more on medical care. Yet the United States also spends substantially more than peer nations, even though we have fewer physicians (and fewer physician consultations) relative to the population than other nations. This higher level of spending does not appear to produce consistently better results on health indicators such as life expectancy. To be sure, the United States has higher obesity and poverty rates than many European countries. But multivariate analysis that controls for income, environmental quality, and lifestyle across developed nations finds little connection between spending and health outcomes. Some experts believe that the U.S. medical system is distinctively inefficient. As economists Henry J. Aaron and Paul B. Ginsburg write, "Whatever the reason, it is hard to avoid the conclusion that the United States is buying less health than other nations do with its high outlays."

It is critical to distinguish between the total benefits of greater health spending over time and the benefits of extra health spending at the margin. Over time, new technologies are developed, and some of them are associated with substantial improvements in health outcomes. For example, the mortality rate from cardiovascular disease has declined by more than 50 percent since 1950, at least partly because of the development of better ways to treat heart disease. At any given moment, however, the knowledge about how to treat different conditions is fairly similar across developed countries. The key issues are "how much the technology is used and how much is paid for it. By comparison with other countries, the United States uses technology in lower value settings and pays more for the same care." This pattern likely stems from a combination of factors, including the absence of overall budgetary limits and supply-side constraints on medical capital equipment. In sum, all advanced democracies struggle with the cost and efficiency of health care delivery. However, the United States faces special challenges. Our financing and delivery systems are an unusually complex, decentralized, highly commercialized admixture of public and private plans that lack both the discipline of efficient markets and the authority of government control.

Most experts agree that a substantial portion of the U.S. medical outlay is spent inefficiently, leading to little improvement in quality or outcomes. The Institute of Medicine estimates that as much as one-third of overall U.S. medical spending is wasted annually. The United States spends $2.5 trillion annually in health care, so this corresponds to over $750 billion in waste each year — more than the budget for the Department of Defense.

As health economist David Cutler argues, waste is marbled throughout the health delivery system, making it hard to cut out. It comes in many forms, including excessive administrative costs, inflated prices, fraud, and — of especial concern in our analysis — overtreatment. Overtreatment includes "care that is rooted in outmoded habits, that is driven by providers' preferences rather than those of informed patients, that ignores scientific findings, or that is motivated by something other than provision of optimal care for a patient." According to some estimates, overtreatment added between $158 billion and $226 billion in wasteful spending in 2011. No area of medicine is immune. Overtreatment exposes patients to treatments that offer little or no health benefits as well as potential harms. Sometimes entire classes of care are inappropriate, but overtreatment also arises when a given treatment is used more intensively than clinical conditions warrant. An example is using back surgery as a first-line therapy for patients with simple cases of back pain/discomfort who would benefit from much less invasive procedures, such as drugs or physical therapy.

Consider this puzzling situation. According to a CDC study, every year about 60 percent of American women who have had a total hysterectomy and lack a cervix receive a Pap test for cervical cancer. While there are some posthysterectomy women who need to continue screening (such as those whose surgery was done to remove cancer), the number is small. As one obstetrician stated, "It's tough to get cervical cancer without a cervix." According to the CDC, "the net benefits of screening some women, particularly women who have undergone hysterectomy ... might be outweighed by the net harm (e.g., false-positive tests leading to needless patient anxiety and invasive procedures)." The U.S. Preventive Services Task Force, the American Congress of Obstetricians and Gynecologists, and American Cancer Society all recommend against Pap tests for posthysterectomy women over the age of 30. Yet despite the scientific consensus against routine screening for cervical cancer posthysterectomy, the proportion of women over 30 years of age who have had a hysterectomy and recently have been screened declined only 15 percentage points between 2002 and 2010 (figure 1.2).

Screening posthysterectomy women for cervical cancer points to a larger problem. Harvard Medical School researchers analyzed Medicare claims data, looking at 26 tests and procedures that empirical research has shown not to be beneficial for patients. They found that at least one in four — 25 percent of — Medicare recipients received one or more of those services in 2009. The 26 services "are just a small sample of the hundreds of services that are known to provide little or no medical value to patients." "We suspect this is just the tip of the iceberg," said study author J. Michael McWilliams.

Millions of Americans receive antibiotics, MRIs, blood tests, diagnostic screenings, and surgeries they don't need. Atul Gawande, a general surgeon who has been at the vanguard of the EBM movement, reports that he took a look at eight new patients who entered his clinic one afternoon. All had medical records complete enough to permit him to review their histories. Gawande found that seven of the eight had received unnecessary care. Two had expensive diagnostic tests of no value. A third patient had undergone a questionable surgery for a lump (which the surgery failed to remove).Four patients "had undergone inappropriate arthroscopic knee surgery for chronic joint damage." These results occurred at one of the most prestigious and sophisticated medical institutions in the world. All these unnecessary treatments not only increase costs, but they can also imperil health by exposing patients to a higher risk of side effects and medical errors. "What's remarkable is how much we do with so little evidence to support what we do, especially when it comes to the patient right in front of us," said Harlan Krumholz, a cardiologist at Yale University. As David Epstein wrote in an Atlantic magazine article, "When Evidence Says No, but Doctors Say Yes":

For all the truly wondrous developments of modern medicine — imaging technologies that enable precision surgery, routine organ transplants, care that transforms premature infants into perfectly healthy kids, and remarkable chemotherapy treatments, to name a few — it is distressingly ordinary for patients to get treatments that research has shown are ineffective or even dangerous. Sometimes doctors simply haven't kept up with the science. Other times doctors know the state of play perfectly well but continue to deliver these treatments because it's profitable — or even because they're popular and patients demand them. Some procedures are implemented based on studies that did not prove whether they really worked in the first place. Others were initially supported by evidence but then were contradicted by better evidence, and yet these procedures have remained the standards of care for years, or decades.

We live in an age of Big Government. There is no shortage of federal rules that govern the health care sector, and agencies like the Food and Drug Administration are among the most powerful and best known regulatory agencies in the world. Americans could be excused if they believe (without thinking much about it) that existing regulatory frameworks ensure that new treatments enter into clinical practice only after research has shown that they work as well as or better than alternatives, and that very expensive treatments must work at least as well as much cheaper alternatives. But this belief is mistaken.

To be sure, drugs and devices must be certified as safe and effective by the FDA before they can be marketed in the United States. There are three main reasons why the FDA approval process often fails to generate the information needed to promote evidence-based medicine, curb wasteful spending, and ensure the best outcomes for patients. The first reason is that the assessment of comparative effectiveness is typically not required for FDA marketing approval. Despite calls from medical reformers for greater attention to comparative effectiveness and the benefits of a new therapy over alternatives,

the FDA has stuck with the older (and industry preferred) model of placebo studies as the gold standard by which to measure the efficacy of new products, a decision that some have argued has escalated drug costs by facilitating the introduction of expensive 'me too' drugs which offer only marginal efficacy gains, if any, over existing off-patent therapies.

Clinical trials of new drugs typically compare them to alternative medications only when the manufacturer seeks to make a marketing claim that a product is superior to other treatments, "or when giving trial participants a placebo would be unethical." Furthermore, the FDA's evaluations of products are often designed only to see if they are more effective than placebo on a short-term surrogate endpoint, such as a blood test, which may or may not be a good proxy for long- term clinical outcomes. Physicians commonly prescribe FDA-approved drugs for "off-label" uses — that is, for uses (and types of patients) in which the drugs have not been tested in clinical trials. Most physicians are not being irresponsible in these practices; the evidence base simply does not exist for many of these uses, especially for the off-label use of drugs.

A second reason why FDA review fails to generate the information needed to determine what treatments work best for what patients is that the evidentiary standards for evaluating medical devices are typically lower than for prescription drugs and biologics. Many medical devices enter the market through an expedited pathway, in which manufacturers need only demonstrate (usually without evidence from randomized controlled trials) that a new device is "substantially equivalent" to a device already being sold. As mentioned, some point out that the 21st Century Cures Act, intended to expedite the approval of new drugs and devices, could affect the quality of evidence used by the FDA to evaluate new products and new uses for existing ones. In sum, federal regulation of medical products has been crafted to protect safety by keeping dangerous drugs and devices off the market, not to ensure that patients get the treatments that work best for their conditions.

The third gap in the FDA review process, less well known than the other two reasons but perhaps more important, is that many medical procedures undergo no rigorous evaluation at all. While the FDA does review devices used in medical procedures, it generally does not regulate the efficacy of the procedures themselves. This means that a doctor who invents a new kind of surgery can generally begin performing it without extensive evidence that it works better than less invasive alternative treatments. As Ashton and Wray observe, "Paradoxically, surgical innovations, generally costlier and riskier than pharmaceutical agents, can enter clinical practice with a much weaker evidential base than drugs and devices."

The weaknesses of the FDA are compounded by the federal government's incapacity to promote efficiency in programs like Medicare and Medicaid. While all advanced nations are struggling to eliminate waste in health care, the United States is somewhat of an outlier when it comes to the use of evidence to shape coverage and reimbursement decisions. Australia, France, Germany, and the United Kingdom, for example, all have CER entities with greater authority than PCORI. These organizations differ in their roles and responsibilities, but all focus "their priorities, design, generation, and implementation of CER evidence on the explicit objective of informing health care policy decisions on the use of and payment for clinical services." In comparison, CER entities in the United States have been given fewer tools to influence how health care resources are allocated.

In contrast to the agencies that administer public health insurance programs in other advanced nations, the Center for Medicare and Medicaid Services lacks the ability "to actively review the vast majority of new technologies that are adopted into clinical practice and to restrict coverage for those that lack sufficient evidence of effectiveness." Since its enactment in 1965, Medicare has focused primarily on clinical effectiveness, and covered any treatment that it deems "reasonable and necessary." It has not sought to constrain or limit patient choice about treatment options. Medicare delegates most coverage decisions to regional contractors, who generally defer to the clinical judgment of physicians. Even when national coverage policies are developed (which applies to only a small fraction of medical services), the lack of high-quality outcomes data means that "the vast majority of new technologies and services bypass any meaningful review." Medicare has not been a regular sponsor of clinical trials to address gaps in the medical evidence base, although on some occasions Medicare has sought to link the coverage of a new service to providers who participate in a prospective data collection activity by a process known as "coverage with evidence development." While Medicare has sometimes limited payments for a service to the rate paid for the "least costly alternative," Medicare reimbursement levels in the vast majority of cases are linked to the "underlying cost of providing services." Administrations of both parties have sought to rationalize Medicare's coverage policies to give greater weight to the costs and benefits of services, but reforms have been elusive. In the early 1990s, the George H. W. Bush administration proposed a Medicare coverage rule that would have included a limited cost-effectiveness analysis requirement for certain technologies. However, the proposal was opposed by the medical device industry, physician associations, and hospitals. Members of Congress and disease-advocacy groups argued that cost-effectiveness analysis would lead to rationing, and the proposed rule was buried before the 1992 elections.

(Continues...)

Excerpted from Unhealthy Politics by Eric M. Patashnik, Alan S. Gerber, Conor M. Dowling. Copyright © 2017 Princeton University Press. Excerpted by permission of PRINCETON UNIVERSITY PRESS.
All rights reserved. No part of this excerpt may be reproduced or reprinted without permission in writing from the publisher.
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Dettagli dell?edizione

• Editore: Princeton Univ Pr
• Data di pubblicazione: 2017
• ISBN 10: 0691158819
• ISBN 13: 9780691158815
• Rilegatura: Copertina rigida
• Lingua: Inglese
• Numero edizione: 1
• Numero di pagine: 259
• Contatto del produttore: non disponibile