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Harvard Health Policy Review Spring 2002; Volume 3, Number 1 [Note: This online edition of the Spring 2002 issue is slightly modified from the original version only to accommodate formatting changes. All the content of the pieces remains the same as the original unless noted in text.]

Editor's Note The "Clinical Research" Features topic in the Spring 2002 issue of the Harvard Health Policy Review addresses some of the more pressing challenges in conducting safe, effective, and ethical medical research. Clinical trials with human subjects offer more promise than ever before, but we must balance their rewards with their potential dangers. As the articles in this Features section make clear, the patient's interest must always remain the top priority in medical research. In his interview to begin the section, Harvey V. Fineberg, President of the Institute of Medicine (IOM), discusses a wide range of issues in medical research including its expanded scale since the end of the Second World War. He describes the development of "a very different model for shared decision making," in which patients are entitled to more information and have greater opportunity to express their preferences in clinical research. In the following article, "Swinging on the Pendulum: Shifting Views of Justice in Human Subjects Research," Anna Mastroianni and Dr. Jeffrey Kahn argue that the concept of justice in human subjects research has also shifted over time - from a focus on "protection" to one on "access." They note that the pendulum of research ethics policy swings freely between these two principles. The section's final article, by Ronald S. Newbower, Vice President of Research Management at Partners Healthcare, examines more closely the necessity of protecting patient safety by preventing financial conflicts of interest in human subjects research. Dr. Newbower analyzes the relationship between institutions and researchers in establishing and upholding the highest possible research standards. The In Focus section that follows tracks three critical areas of focus for the coming generation of health policymakers: the issues of long-term care, managed care, and human cloning. Tomoko Shinoda-Tagawa and Soichi Koike conduct a comparative analysis of how the United Kingdom, Germany, and Japan are facing the challenge of providing quality long-term care to a growing population of elderly persons. In the subsequent article, Marty Shanahan outlines the regulatory framework that will govern another issue for the future: the appropriate uses of human cloning technology. The last article in the section, by Michael Housman, asks, "Can Managed Care Consumers Make Informed Decisions?" Now that managed care has developed into a mainstay in the American health care system, the challenge going forward is to understand its impact on enrollees. As Housman's regression analysis of a survey he conducted demonstrates, the Â

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public is still struggling to understand the various characteristics of managed care plan types. The first of three articles in this issue's Health Highlights section considers the issue of medical ethics in a managed care environment. Dr. Allan M. Brandt, Director of the Division of Medical Ethics at Harvard Medical School, argues that, "as medicine changes, so must our medical ethics." Dr. Jonathan L. Burstein, Chief of Disaster Medicine at Beth Israel Deaconess Medical Center, discusses the research priorities for public health authorities attempting to develop their ability to respond to bioterrorism. Finally, Gillian Warmflash contrasts how the publishing of surgical outcomes data has provoked a strong response among health care providers but a surprising level of apathy among patients. In this issue, the Harvard Health Policy Review is proud to introduce an International Health section for the first time in its publication. The HHPR will devote this section to health policy in other nations as well as to international health policy regarding topics of global significance. In this first edition of the section, we include an interview with Professor Jeffrey Sachs, Director of the Center for International Development at Harvard University. Professor Sachs recently chaired the World Health Organization's Commission on Macroeconomics and Health (CMH), which published its report on poverty reduction and global economic development in December 2001. A summary of the report by Derek Willis is published alongside the interview. In addition, Yanzhong Huang's article, "The Paradoxical Transition in China's Health System" studies how China's transition between a Maoist health system and marketoriented reform and argues that elements of the Maoist system continue to maintain their influence. Finally, Jordan Swanson addresses the poignant issue of acid violence in Bangladesh, where efforts to monitor and control acid violence have only recently been developed and are struggling to decrease the incidence of these damaging attacks. The Harvard Health Policy Review would like to encourage its readers to visit our website at www.hhpr.org. Our archived content is available online, as well as additional information about the HHPR's history, goals, and contact information. Please contactepihc@hcs.harvard.edu with general questions or subscription requests. David Sclar Editor-in-Chief Spring 2002

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Table of Contents Features: Clinical Research Interview with Harvey V Fineberg Fellow at the Center for Advanced Study in the Behavioral Sciences in Palo Alto 5 Swinging on the Pendulum: Shifting Views of Justice in Human Subjects Research Anna Mastroianni, JD, MPH and Jeffrey Kahn, Ph.D., MPH 10 Conflicts of Interest in Medical Research Ronald S. Newbower, Ph.D. 19

In Focus Long-Term Care: Lessons from the United Kingdom, Germany, and Japan Tomoko Shinoda-Tagawa, MD, MPH and Soichi Koike, MD, MPH 28 Unfamiliar Regulatory Risks: Lessons to be Learned from Federal Regulation of Human Cloning J. Martin Shanahan, CPA, JD 36 Can Managed Care Consumers Make Informed Decisions? Michael Housman 42

Health Highlights Bioethics: Then and Now Allan M. Brandt, Ph.D. 51 Sparks or Smarts: Defending Against Bioterrorism Jonathan L. Burstein, MD 55 Patient and Physician: Responses to Publicized Medical Outcomes Gillian Warmflash 58

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International Health Interview with Jeffrey D. Sachs Director of the Center for International Development 60 Establishment of the Commission on Macroeconomics and Health Derek Willis 66 The Paradoxical Transition in China’s Health System Yanzhong Huang, Ph.D. 75 Acid Attacks: Bangladesh’s Efforts to Stop the Violence Jordan Swanson 82 © 2002 by President and Fellows of Harvard University. All rights reserved. No part of this publication may be reproduced in any form without permission in written form from the publisher.

Features: Clinical Research Interview with Harvey V Fineberg Conducted by Edward Sun HHPR: Given your extensive background in medical ethics, we'd like to ask how ethical decisions are currently made in biomedicine. HVF: I think it goes to the heart of the challenge that we don't have routinized standards, or forms for reaching those policy choices. So in the case of stem cells, for example, there have been scientific groups (like those assembled by the National Academies), and there are ethical panels (like that the president assembled in the White House); there may be more following that. We don't have a kind of constitutional definition of procedure and this makes the debate very rich, opening up opportunity for many participants. This is good because it ensures that no one or no one group will prevail merely because they are delegated authority by society, because they're going to have to make arguments that persuade people. HHPR: The editors of the book entitled Understanding Risk: Informing Decisions in a Democratic Society, of which you are one, stress the need for a "broad understanding of the relevant losses, harms, or consequences" of risk situations. Do you believe that the medical community and the government have adequately created this "broad understanding" in matters such as stem-cell research and the cloning of humans? HVF: It's a very interesting juxtaposition of issues of risk in the stem-cell search. And the reason I say it's interesting is because the most problematic aspect of the issues around stem-cell research is not so much the risks to people, as it is the moral questions about the process of doing the research. When we wrote about risk, and awareness of risk, and communication of risk, and involvement of the public, we had more in mind situations where technology in its application introduced, or might have inadvertently introduced, certain risks and the way in which people were aware of them. In the situation with stem-cell research, we're at an earlier stage, where the public issues are moral judgements about the meaning of human life and the correctness of using embryonic forms for research. The issues have been mainly concerned with the validity of using tissues or cells that have life potential in research intended to aid others than the being, who is perhaps in formation. And then, there's the deep concern from some about the being in potential, the objection even reaches then to stem-cells that themselves have no prospect whatsoever, for physical or practical reasons, of ever becoming a being. So this is where the objection is raised even for stem cells that are otherwise going to be destroyed or left in the freezer. But it emanates from a kind of slippery-slope argument that we are at risk of then losing sight of what is considered a more dangerous use by these critics, namely cells that might otherwise become a human being. I see the issues around stem-cell research as being, in a sense, tangents to the issues around risk in a more general sense. HHPR: Has the public's understanding of risk in human research been influenced by the Â

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tremendous scientific technological advancements witnessed in the past decade or so? HVF: Many people are more aware of danger in technology for medical care and for other aspects of our lives, energy use and the environment. Some of the difficulties, for example, are in the form of contending or alternative risks. It's a very interesting illustration of this with a chemical additive for gasoline that was introduced after the 1990 Clean Air Act. Its abbreviation is MTBE for Methyl Terbutyl Ether, and it's an oxygenation compound that's designed to reduce carbon monoxide and other precursors of air pollutants that are produced by combustion gasoline. The problem is that it fouls the water and the ground water in the U.S. is now contaminated with this chemical. That's an illustration of where you're trying to solve one risk problem, mainly carbon monoxide and air pollution, and another risk problem is introduced in the contamination of our ground water. The parallel to that is where you introduce a technology with which you tend to have benefits, but inadvertently have unforeseen side effects. It happens with procedures, it happens occasionally with vaccines and in each case, you have to judge whether the benefit outweighs the burden of the risk. HHPR: This summer, a healthy patient died while participating in a Johns Hopkins asthma study. How has the public's perception of research changed in light of such instances? HVF: I think such incidents give research and researchers a black eye in the public mind, and in that way they do harm not only to the particular researchers and to the questions that they're asking but really to the enterprise of science. So, in that instance, the problem was not that there were risks (which there may be); the problem was that the way this research was carried out did not provide informed consent or provide adequate safeguards to the individuals participating in the research. That was the flaw. It's one thing if you are a patient and you may have a very dire disease, perhaps it's life threatening, and you volunteer to enter a trial because you may want to help other people and you want to do something worthwhile. It's very important when you make that judgement that you have all the information about what is known. And you are entitled to the very best care consistent with the treatment that you'll be given. In the cases that you cited, that was actually a healthy volunteer, not a patient, and the safeguards were not put into place. The stem cell research, clinical research, and the application of technology each raise slightly different aspects of the worry or the concern we've been discussing. You have a scientific experiment, and whether you're going to do it (like in stem-cell research) depends mainly on the moral question. When you have the experimental intervention in a disease, or to understand better a disease process (as you mentioned inside the Hopkins case), the important obligation there is for informed consent and adequate safeguards. When you have other treatments or interventions, whether they're clinical, individual, or population-based, or even, if they involve social intervention, you have the obligation then to do the kind of communication you started to ask about and to make sure, as best you can, that the benefits really will outweigh the risks. HHPR: This necessity for informed consent seems to result from a greater public involvement in scientific research. Perhaps the introduction of such parties as the public Â

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began with the Second World War. Before World War II, research decisions were largely relegated to the scientific community itself. Afterwards, the government began to decide if not define the nature and direction of scientific advancement. Today, major players include both the public and private sectors. How has the nature of research evolved given the broadening audience? HVF: I think, first, the most salient feature of research over the last 50 years is how the scale of research has grown so much in the period after the war. I would say that the Second World War was a really an eye-opening time for understanding the power of science to affect our lives. That was so obvious, the war effort and the critical role the scientists played in the development of nuclear devices at the end of the war, and indeed technology throughout the war. It was just a higher order of intensity than in any previous epoch in history. And then you have real visionaries like Vannevar Bush [Director of the Office of Scientific Research and Development] with his essay, "Science: The Endless frontline, the Endless Frontier" (United States Government Printing Office, Washington: 1945), outlining a vision of the way in which science could progress. With the investment that followed in the government, particularly in biomedical research, with the growth of the NIH, the private sector, the kind of multiplication of investment that you alluded to (the enterprise nationally) became much more complicated and far-reaching. And then you compound that with the more recent advent of what we might call non-government organizations. On the international scene, they're usually referred to as non-government organizations, but in the U.S., domestically, we tend think of them as volunteer interest groups. We have, for example, with the AIDS epidemic, and especially in some of the cancer populations, groups who are playing particularly active and effective roles in shaping policy, not just in research but also in care. So you've got a series of trends that have combined over the last decade, which have produced a more complicated, grander, and riskier enterprise of scientific research. HHPR: And it certainly seems that the more complicated the enterprise gets, the more informed all the parties involved need to be about all the risks, especially patients and research participants. HVF: I think that that's a very valid point. It may be that people were always entitled to the same degree of information, but they weren't always insisting in the same way about it, or it wasn't as much on everyone's mind. You know, medicine -- as it was practiced a generation ago -- was very different in the degree of paternalism that physicians exercised. The old, classical model in the post-war period, certainly throughout the seventies was really that of the senior physician (typically a man) who told you what to do and as a patient, you did it. Now you've got a very different model for shared decisionmaking and mutual responsibility, and the focus has shifted more on informing and less on just directing. People have come to appreciate that individual' preferences and values are just as valid parts of the decision making as the physician's clinical and technical expertise. HHPR: One benefit from such a different model of practice and decision-making is that such atrocities as the Tuskegee Syphilis experiment are inconceivable today. For forty Â

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years between 1932 and 1972, the U.S. Public Health Service (PHS) conducted an experiment on 399 black men without informed consent. These men, largely illiterate sharecroppers from the poorest parts of Alabama, were left to degenerate under the horror of tertiary syphilis (which could include tumors, heart disease, paralysis, blindness, and death). HVF: I think we'd like to say that it's inconceivable, but who would have thought in the early part of the 20th century that the 20th century would have witnessed so much unbelievable horror that humans have inflicted on one another. You would like to believe science progresses in a fashion that makes that sort of exploitation unthinkable and I hope it's true. But I believe the lesson I take away from Tuskegee and from all other experiences of the last century is that we, as citizens, have to remain ever vigilant. We cannot take for granted that unspeakable things are unthinkable and cannot happen. It requires a vigilant populous. HHPR: Has biomedical research become more "vigilant" with respect to health risk after the September 11th tragedy? HVF: It gave attention to a host of problems that were present, pre-existing the anthrax and "Nine-eleven episode," which were not as evident or as appreciated before. For example, vaccine development and deployment in the United States represents one such issue. The state of the public health infrastructure, by which I mean things like laboratories, local capacities, communication, all the things that enable prevention and rapid response, is another. The technical issues around surveillance and monitoring, both the sense of security from a physical harm point of view, and in terms of security from microorganisms represent a third pressing issue of risk that has only now taken a greater role in scientific research. All of these are much more prominent on the research agenda today than they were a few months ago. Deficiencies in such areas have been shown to have significant costs and that has made us more ready to put the investment into fixing them. HHPR: What are some responsibilities that the medical and scientific community can assume in preparing for bio-terrorism? HVF: Quite a lot actually, in my opinion, because if you even look at the anthrax experience, it was an alert clinician who first identified the initial cases. The readiness and ability of medical professionals everywhere in the country to be able to detect and report findings (which could be related to bio-terrorism) is a very important characteristic today's scientists need to possess. Secondly, people do turn to health professionals for guidance and advice, and so the public health system and infrastructure need to be able to provide clear and forceful advice that will help those professionals give their guidance to the public and to their patients. So, the responsibilities extend all up and down the chain of medical practice from individual doctors seeing their patients, and nurses in a community clinic or a local office, all the way up to the highest levels of management and leadership and government.

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Harvey V. Fineberg, MD, Ph.D., the former Provost of Harvard University, is currently a fellow at the Center for Advanced Study in the Behavioral Sciences in Palo Alto. He will begin a sixyear term as president of the Institute of Medicine (IOM) in July 2002.

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Swinging the Pendulum: Shifting Views of Justice in Human Subjects Research Anna Mastroianni, JD, MPH and Jeffrey Kahn, Ph.D., MPH Justice has long been one of the central principles in the ethical conduct of research on human subjects. But its application, as reflected in federal policies pertaining to human subjects research, has undergone a remarkable shift over a relatively short span of time. Understanding this shift is important not only for interpreting claims about justice in human subjects research, but also for assessing the status and adequacy of policies for protecting subjects. In the 1970s, these policies emphasized the protection of human subjects from the risks or harm in research, and justice was seen as part of this protection. Since the early 1990s, however, justice as applied in research ethics has emphasized the need to ensure access to the potential benefits that research has to offer. That such a dramatic shift could occur so quickly is extraordinary, especially in light of the understanding, coalescing over the same period, that subjects have an inadequate understanding of the research in which they are participating and are inadequately protected by existing practices and policies. The tension between these developments offers an important lesson for research protection as the context of human subjects research becomes more complex. Our goal here is to attempt to understand how the pendulum has swung from protection to access, where in its arc we are, and where we should be. Justice in the Belmont Era: Protection from Exploitation The development of human subject protection policy in the United States was driven by a history of exploitation of subjects, most notably by research on "vulnerable" subject population that came to light between the mid-1960s and the early 1970s. The landmark examples were the Willowbrook State School hepatitis vaccine research on institutionalized children; the Jewish Chronic Disease Hospital cancer research, involving the injection of cancer cells into elderly nursing home residents; and the so-called Tuskegee Syphilis Experiment, which had been under way for decades but exposed to an appalled nation in 1972. Those examples contributed to a sense that human subjects research in the United States permitted scandalous practices-inadequate attempts to inform subjects about research and obtain their consent, exploitive recruitment strategies, the use of vulnerable subject populations, and a willingness to expose subjects to significant risk without any potential for direct medical benefit. Further, there was a sense that the risks and benefits of research were split apart-the risks were borne by subjects, the benefits accrued to others. Thus the early history of U.S. research ethics policy focused on the risks rather than the benefits or research, and on preventing subjects from being exposed to unacceptable or exploitive levels of risk, particularly without the prospect of offsetting direct medical benefits. The Belmont Report, issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1978, identified justice as requiring the fair distribution of the burdens and benefits of research in subject selection Â

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and recruitment; in practice, however, justice was interpreted as requiring the prevention of any further exploitation of vulnerable groups. The emphasis was realized through the promulgation of research policies that staked much on protection and that singled out particular groups-namely, prisoners, children, and pregnant women and fetuses-for additional protections. Prisoners were deemed vulnerable because of the nature of their living environment. Adequate informed consent, it was believed, was not possible when subjects lived in a setting that constrained the autonomy on which the concept of informed consent is based. This view actually ran counter to information collected by the National Commission, which found in interviews with prisoners who participated in research that the prisoners wanted to be enrolled in studies and were highly motivated research subjects, for a variety of reasons-the opportunity to earn a few extra dollars, the perks that might come with research participation, access to more frequent and potentially improved health care, and a belief that participating in research offered a way for them to make a contribution to society. Most interesting was the finding that it was not the least powerful and arguably most vulnerable prisoners who participated in research, but the most powerful. Prisoners often viewed research as an opportunity to be seized rather than a hazard to be avoided; they apparently did not worry that anyone was taking advantage of them. Even so, policies were promulgated, and remain in place today, that made it impossible to perform research on prison populations unless the research either offers a prospect of direct medical benefit to the individual subjects themselves, as in clinical trials for HIV infection, or aims at understanding or improving the prison environment, such that it would potentially benefit prison populations generally. Children were deemed vulnerable because of similar concerns about informed consent and the potential for taking advantage of their reliance on others. Such concerns were vividly illustrated in the infamous Willowbrook case, where hepatitis vaccine research was performed on institutionalized, mentally retarded children whose parents seemed to have little choice but to agree to their children's participation, thereby picking out the most vulnerable from among the potential pool of children. The rules developed to prevent this sort of exploitation limited research in which children could participate to studies involving either minimal risk or direct medical benefit. Pregnant women and fetuses were deemed especially vulnerable and deserving of protection. Influenced by the abortion debate and memories of thalidomide, policymakers protected pregnant women from research that carried risk of harm to protect them and their fetus. The implementation of this policy was expanded in practice to include not only pregnant women but also women of childbearing capacity, both to prevent unwitting risk to refuses and to protect the future health of the women. This practice represented the logical conclusion of a regulatory culture and process that emphasized the protection of subjects from risk as paramount. From Protection to Access The research regulatory culture that emphasized protection from risk in the 1970s began to shift during the late 1980s and early 1990s. Due to a growing belief that Â

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research increasingly offered real benefits, the application of justice in research began to emphasize the fair distribution of the benefits of research instead of its risks. Advocacy groups, particularly those representing the interests of people with AIDS and women's health groups, argues this view to great effect before Congress and elsewhere. The thrust of their position was that fairness demands not only protection from the risks of research, but increasingly demand the opportunity for inclusion in research. The shift was taking place: from justice as protection to justice as access. The HIV/AIDS advocacy community was at the forefront of making the case for justice as access. As the first clinical trials for AZT were being undertaken, groups like ACTUP organized rallies protesting the limited enrollments in them. At a time when subjects were sharing their research medication with friends to spread around whatever potential benefit could be had from these drug trials, protestors were marching in large cities across the country carrying placards proclaiming, "Clinical trials are health care too!" Such a sentiment, conflating research participation with medical care, represented not just a shift in emphasis but total reversal of the ethics of research from protection to access. Through the late 1970s and 1980s, there was a growing sense that cutting edge therapy could be found in research participation, particularly for cancer, where the best therapeutic outcomes were thought to be in research protocols, and where standard treatment modalities were largely viewed as less effective. It was certainly true that the benefits from the major investment in biomedical research were being realized and applied. The problem was that those benefits were limited to the populations represented in the subject populations-largely although not exclusively adult males. Whatever the complex of reason for excluding women, racial and ethnic minorities, and children from research participation, the policy was largely predicated on protection from harm and exploitation. But as advocates began to point out, such policies had the effect not only of preventing harm and exploitation, but also of preventing benefit-resulting, claimed one commentator, in a climate that protected some groups to death. Exclusion denies access to the benefits of research at two levels-first to the individuals who may themselves receive the direct medical benefit of research participation, and more notably to the groups from which the subjects come. There are numerous examples of the research system's failure to provide equitable benefits to women. Among the most notable is the United States Physicians Study, and longitudinal study that assessed the effectiveness of low dose aspirin for preventing heart attacks. It yielded strong evidence of success, but it couldn't be applied outside the research population, comprised exclusively of men, because women are not merely smaller versions of men. Similarly, children are not merely smaller versions of adults, and racial and ethnic groups may differ from each other in disease pathology, drug response, and the like. The realization that policy and practice had emphasized protection and a denial of the real and perceived benefits of research pushed the pendulum of research policy toward recognizing the importance of access to the benefits of biomedical research, by means of policies requiring inclusion in research set against a background of protection. In 1994, Â

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less than twenty years after the first federal policies on research protections were promulgated, the NIH issued the first policy requiring inclusion of particular groups in research-the Guideline on Inclusion of Women and Minorities in Research. The guideline represents an unprecedented sea change in thinking about the ethics research on human subjects. Implementing Justice in Policy The implementation of the 1994 NIH guideline flipped the presumption about research participation from exclusion to inclusion. Researchers were and are now required to include representative populations of women and minorities in their protocols unless there are special reasons for excluding them. It would make no sense, for example, to include women in a clinical trial testing a new drug for prostate cancer, nor would it be reasonable to conduct research on conditions in racial or ethnic groups in which those conditions are not found. Policy on the participation of children in research is following a similar path, driven by similar arguments. In an effort to protect children, children have been excluded from research that carried greater than minimal risk unless the research also had the potential to provide direct medical benefit to the subjects. Thus federal regulations (subpart D of 45 CFR 46) bar the participation of children in phase I drug trials, which are used to assess the safety of new drugs before their approval. But excluding children from such research has meant there is limited information about the safety of drugs in pediatric populations. This information has instead been pieced together after the drugs are approved and marketed for adults: children have received drug doses based only on the most general calculations of their size relative to the adults for whom drugs are approved, and on the clinical experience (read "trial and error") of pediatricians who have begun to try the drugs on children. Recent directions from both the NIH and the Food and Drug Administration are changing the presumption from exclusion to inclusion, and requiring a special justification to exclude children. The change in approach has not been completely achieved, however. Reversing the presumption about participation has resulted in a policy that reflects the tension between ensuring access to the benefits of research and protecting the subject from research harms. The dictates of subpart D, as currently written, do not easily coexist with a policy of inclusion. It appears that the long-standing commitments to protection will be weakened as part of the trend toward assuring access to the benefits of research. Changes in the rhetoric of health policy are further evidence of the emphasis on access to the benefits of research, reaching to the highest levels of our government. Richard Klausner, director of the National Cancer Institute, testifying before Congress in 1998 about the need for large increases in the overall NIH budget (which were eventually granted), argued that substantial additional resources were required "to ensure that all people who wish to participate in a clinical trial are able to do so." The comment both presupposes that there is a real benefit to be had by the subjects of clinical research and reflects a remarkable commitment to universal access to research participation, Â

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particularly in a country where there is no similar commitment concerning basic health care. Klausner's commitment has now been realized in policy, at least for those who have health insurance or are eligible for Medicare. In 1999, United Healthcare, one the largest managed care organizations in the country, became the first third-party payer to agree to pay the cost associated with their subscribers' participation in clinical trials. The decision was hailed as a major step in removing one of the substantial barriers to participation in clinical trials, since the policy of most health insurers has been to deny payment for the costs of clinical trial participation on the grounds that the treatment rendered is experimental. Whether the change in policy is a function of a changed view of the benefits of research participation, a response to the demands of its customers, or a commitment to supporting the research that yields the clinical advances on which health care depends, it certainly delivers a message to patients. If your insurance company thinks research is worth paying for, it must be worth participating in. Not long after the decision was announced, then-President Bill Clinton directed the Health Care Financing Administration to ensure that all Medicare recipients would enjoy similar access to clinical trial participation, leaving it to policy-makers to determine the conditions under which patients would be eligible for such a benefit. This theme even became part of the rhetoric of the presidential campaign when Al Gore incorporated a reference to access to research participation in his standard stump speech on health care issues. The final piece of evidence that the pendulum has swung fully from protection to access is the waiver of informed consent in research in emergency settings, written into federal regulations in 1996. The waiver is the ultimate endorsement of an emphasis on the benefits of research since it suggests that research participation is so beneficial, to individuals and society, that we must guarantee access even for those unable to consent. With this step we have now backed away from the cornerstone concept of informed consent, dating back to the Nuremberg era, in the protection of research subjects. A New Era in the Protection of Human Subjects? What are the implications for research oversight of the wing from protection to access? The protection of the rights and interests of research subjects is rightly the preeminent concern in research oversight, but how do we ensure that protection is adequately balanced against access? There is ample evidence that even in an environment stressing protection there are serious shortcomings in the process of informed consent, and subjects are persistently confused about the distinction between research and clinical care and the benefits they stand to realize by participating in research. Thus an overemphasis on the benefits of research participation can undermine the reality that research inherently carries risk and very often holds no benefits to the subject. It is a confusing time to be a subject-or to be thinking about becoming one. The media presents stories about the need for more research and research funding alongside reports of serious harms to subjects in research trials. The death of Jesse Gelsinger in a gene transfer study at the University of Pennsylvania resulted in a swirl of reportage, congressional hearings, university investigations, and new restrictions and reporting Â

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policies for gene transfer research. The Seattle Times recently reported on alleged conflicts of interest and failures to obtain informed consent in two clinical trials in which some subjects died unexpectedly, both at Seattle's Fred Hutchinson Cancer Research Center. The Los Angeles Times ran a story on "seven deadly drugs" that were fasttracked to approval by the Food and Drug Administration and were subsequently withdrawn from the market after they were discovered to have serious side effects, sometimes leading to death. And it was recently reported that the FDA has asked for an additional $36 million in the next fiscal year to increase its "emphasis on high-risk trials, such as those enrolling vulnerable populations (mentally impaired and pediatric populations, for example) and sponsor-investigators who have proprietary interest in the product under study. How do we reconcile these divergent messages to subjects, investigators, IRBs, and institutions, and properly balance the requirements of justice in research? If we fail to answer this question adequately we risk serious erosion of trust in the research enterprise. Looking Ahead Accountability for balancing protection and access falls to those at every level in the conduct of research: the physicians who refer their patients to investigators, the investigators themselves, the IRBs that oversee research, and the institutions where research is performed. Policy-making does not occur in a vacuum; regulatory and spending decisions respond to the perceived needs and expressed desired of the public. Without trust from the public, there can be no research, as there will be no research subjects willing to participate and no willingness on the part of the public to support research with tax dollars. Research is a privilege not to be presumed or exploited, but earned through building and maintaining the public trust. This requires a careful balancing of access and protection. Recent announcements by the Department of Health and Human Service's Office of Human Research Protections focus on conflicts of interest in research-at base an effort to secure public trust by ensuring that investigators are not motivated to overlook subjects' protection. The Institute of Medicine recently completed a study recommending, among other things, the accreditation of IRBs. But both of these steps seem to be aimed at assuring that paperwork requirements are met, which is at best a weak proxy for assuring adequate protection of subjects. Thus both efforts seems to miss the point-certification and oversight provide a way of inspecting the implementation of policies aimed a protection rather than a way of exercising them. And thus these approaches encourage us to overlook the nagging, recurring, and fundamental shortcomings in research protections that continue to undermine the trust central to any effort to protect the rights and interests of research subjects, including ensuring their access to the benefits of research. In the current research climate, the pendulum may have swung as far as it can toward an emphasis on benefits. When a pendulum has finished swinging in one direction, it inevitably starts back in the other, and it eventually comes to a rest in the middle. But the direction in which research ethics policy is swinging at any given time will be a function of how well we manage the balance between policies and practices at either end of its two ends. Increasing policy attention to conflicts of interest, reporting, and regulatory Â

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oversight of the research environment seems to imply that the pendulum has begun its swing back towards an emphasis on protection. But paperwork requirements are not enough, and may distract us from efforts that will modulate the swing. What remains to be seen is how far the pendulum will go, and whether we have the tools to control it. This article orginally appeared in the May-June, 2001 issue of the Hastings Center Report. Reprinted here with permission. Anna C. Mastroianni, JD, MPH, is an Assistant Professor at the University of Washington School of Law and teaches courses in health law and bioethics for the the university's Institute for Public Health Genetics. Jeffrey Kahn, Ph.D., MPH, is the Director of the Center for Bioethics at the University of Minnesota. He writes a bi-weekly column about ethics for CNN.com.

References 1. J. Jones, Bad Blood (New York: Free Press, 1993). 2. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for for the Protection of Human Subjects of Research (Bethesda, Md.: Department of Health, Education, and Welfare, 1978). 3. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Report and Recommendations: Research Involving Prisoners (Bethesda, Md.: Department of Health, Education, and Welfare, 1976); V. Cohn, "Prisoner Test Ban Opposed," Washington Post, 14 March 1976. 4. R. Shilts, And the Band Played On: Politics, People, and the AIDS Epidemic (New York: St. Martin's Press, 1987). 5. R.A. Charo, "Protecting Us to Death: Women, Pregnancy, and Clinical Research Trials," Saint Louis University Law Journal 38, no. 1 (1993): 135-87. 6. J.E. Manson et. al., "Aspirin in the Primary Prevention of Angina Pectoris in a Randomized Trial of United States Physicians,"American Journal of Medicine 89 (1990): 772-76. 7. "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," Federal Register 59 (28 March 1994): 14508. 8. "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects," NIH Guide, 6 March 1998, www.nih.gov/grants/guide/1998/98.03.03. 9. R. Pear, "Medical Research to Get More Money from Government," New York Times, 3 January 1998. 10. G. Kolata and K. Eichewald, "Insureres Come In from the Cold on Cancer," New Â

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York Times, 19 Decemebr 1999. 11. R. Pear, "Clinton to Order Medicare to Pay New Costs," New York Times, 7 June 2000. 12. J. Dao, "Gore Urges Doubling of Funds in War against Cancer,"New York Times, 2 June 2000. 13. "Waiver of Informed Consent Requirements in Certain Emergency Research," Federal Register 61 (2 October 1996); 51531; "Protection of Human Subjects; Informed Consent," Federal Register 61 (2 October 1996): 51498. 14. Advisory Committee on Human Radiation Experiments, "Research Proposal Review Project," in The Human Radiation Experiments (New York: Oxford University Press, 1996), 439-58; C.H. Braddock, "Advancing the Cause of Informed Consent: Moving from Disclosure to Understanding." American Journal of Medicine 105 (1988): 354-55; E.D. Kodish et. al., "Informed Consent in the Children's Cancer Group: Results of Preliminary Research," Cancer 82 (1988): 2467-81. 15. Advisory Committee on Human Radiation Experiments, "Subject Interview Study," in The Human Radiation Experiments(New York: Oxford University Press, 1996), 45981; N.F. Kass et. al., "Trust: The Fragile Foundation of Contemporary Biomedical Research," Hastings Center Report 19 (1989): 25-29. 16. P.S. Appelbaum, I.H. Roth, and C.W. Lidz, "The Therapeutic Misconception: Informed Consent in Psychiatric Research,"International Journal of Law and Psychiatry 5 (1982): 319-29; C. Daugherty et. al., "Perceptions of Cancer Patients and Their Physicians Involved in Phase I Trials," Journal of Clinical Oncology 13 (1995): 1062-72. 17. D.S. Greenberg, "Stricter Regulation Proposed for U.S. Gene Therapy Trials," Lancet 355 (1977): 2000. 18. D. Wilson and D. Heath, "Uninformed Consent," The Seattle Times, 11-15 March 2001. 19. D. Willman, "How a New Policy Led to Seven Deadly Drugs,"Los Angeles Times, 20 December 2000. 20. Health Daily News, 11 April 2001. 21. J. Brainard, "U.S. Agency Seeks Power to Fine Universities That Violate Rules on Human Research Subjects," Chronicle of Higher Education, 24 May 2000. 22. S.G. Stolberg, "Experts Call for New Rules on Research," New York Times, 18 April 2001.

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23. J.P. Kahn and A.C. Mastroianni, "Moving From Compliance to Consent: Why We Can and Should Improve on the Ethics of Clinical Research," Archives of Internal Medicine 161 (2001): 925-28.

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Conflicts of Interest in Medical Research Ronald S. Newbower, Ph.D. Biomedical research depends on public support, the strength of which is tangibly demonstrated by the rapidly increasing funding of the NIH. Research institutions cannot take the public's trust for granted if they expect this support to continue. The recent deaths of healthy patients in studies at respected U.S. institutions have focused attention on researchers' conduct. Institutions must understand what factors could lead an investigator to circumvent policies regarding the ethical treatment of human research volunteers. Beyond statistical errors, sloppy science, or flawed logic in analysis, several temptations may conflict with the simple passion for truth. Two such temptations are ambition for advancement in one's field and personal financial gain. Money as a motivating factor for studies is generally greeted with resentment, particularly when it results in lapses of conduct in medical research. In general, financial conflicts of interest are viewed less favorably than conflicts involving personal career ambition, such as the desire to publish or to achieve academic promotion. Institutional policies and practices must address this reality if the public's trust is to be secured. Although the public expects "zero-risk" for research involving healthy subjects, injuries or adverse outcomes occur even in the best of studies. Occasionally, adverse events are associated with lapses in the conduct of the study's investigators, despite the institution's best efforts at education and vigilant adherence to policies regarding research with human subjects. Investigators' misconduct draws scrutiny to the parent institutions - and potentially serious consequences. After a healthy volunteer died last June while participating in a Johns Hopkins asthma study, the federal Office of Human Research Protection (OHRP) withdrew federal funding for most of the university's medical research. This federal punishment drew more attention to a story that had been covered by newspapers across the country. The public pardons institutions only if the misconduct appears aberrant. For the sustenance of the institution's credibility in its total portfolio of research, it is critical that retrospective reviews of an accident or adverse event show strong institutional leadership. Managers may need to guide or even police the conduct of faculty and staff to demonstrate this leadership. Ambition and potential financial gain can lead to subtle bias in the design or conduct of research, including clinical trials of a therapy. In more dramatic scenarios, they may lie behind the deliberate deviation from proper conduct of a study in order to accelerate its conclusion or exaggerate the findings. In the worst case, they may motivate deliberate attempts to deceive the readers of a publication, through the production of falsified results. Â

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Nevertheless, a desire to trust characterizes many consumers' relationships with institutions and companies that deliver goods and services necessary in any field of endeavor, including health services and research. One would like to believe, for example, that our food is always safely prepared. Consumers understand, however, that financial profit - and not simply serving needs responsibly and carefully - motivates suppliers. These financial motivations also affect non-profit institutions and government agencies. When safety or personal welfare are at stake, we set our expectations at a particularly high level. For example, we expect that the government officials who inspect our food, judge court cases, or set the standards for transportation industries are free from personal financial interests and have the public good at heart. Biomedical research and health policy, which deliver unique goods and services, have a greater responsibility to assure quality because patients and consumers have little or no say in these areas. When patients enter a hospital, they have essentially no choice in the discretion of the provider. Even if initial medical need is elective, patients cannot control the many human factors that will govern the quality of care. When patients or healthy volunteers sign "informed-consent" forms for participation in clinical trials, they know little about the backdrop of national or local institutional policy. It goes without saying that the quality of treatment must be the primary interest of care providers. The Institution's Challenge The challenge for the institution is complex because its operation depends on the actions of hundreds or thousands of professional staff, many who have ties with for-profit sponsors, funding agents, and pharmaceutical and medical-device companies. These networks of relationships contribute to the faculty's effectiveness. Similarly, the institution functions as part of a larger national framework which includes governmental sponsors of research and evaluators of research claims for drugs and devices, the National Institutes of Health and the Food and Drug Administration, respectively. For years, proper strategies for an institution's management of research activity have been the subject of extended discussion and debate. After three decades of continuing dialogue marked by highly visible scandals, we now have an overlapping web of guidelines and policies designed to minimize the actual or perceived bias of financial interest in the conduct of biomedical research. Institutions operate within this confusing national framework but are allowed wide latitude of action due to the vagueness of those policies. As a result, institutional policies adopted to meet those vague constraints vary widely. Lo, et al. have demonstrated the range of variation by assessing clinical research guidelines from ten large medical institutions.[1] However, the frequency of exceptions has not been generally reported or collated. Some institutions, and not just individual investigators, are direct or indirect investors in the financial success of companies sponsoring trials conducted in those very institutions, creating a potentially dangerous climate for public trust. These actions seem to contradict the biomedical research enterprise's desire to prevent further erosion of trust in the health care system. As a response, Dean Joseph Martin of Harvard Medical School Â

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is leading an effort to develop voluntary consensus among institutional players.[2]Meanwhile, the General Accounting Office and others recommend federal regulatory policies towards the same ends.[3] Why is consensus so elusive? One reason is the potential for policies designed to regulate ties between researchers and industry to interfere with productive interactions that institutions feel are necessary for the advancement of research and technology transfer. Leading researchers legitimately serve as consultants and on advisory boards for companies, and are entitled to get paid for the time they invest, which is over and above the time required to fulfill their responsibilities to their primary employer. Should that involvement bar these stars from conducting biomedical research, specifically research with human subjects? Should they be forced to choose between these potentially synergistic activities, or are there other ways to accomplish the same goals without the appearance of a conflict? The answers divide opinion leaders and policy makers, public and institutional officials, business executives and faculty members. A compelling case for a clearly defined approach has not yet been made. Case Experience Few institutions have case experience with analyzing and managing conflicts., and many have lack these kinds of policies.[1] Nevertheless, opinions and even national policies seem to be based on oversimplified philosophical analysis, without the benefit of reality testing. The Partners HealthCare System has had over two decades of experience in managing the issues of conflict of interest in biomedical research due to early interest by the Boards of Trustees of the constituent institutions in meeting these challenges. Partners has found that applying consistent standards in resolving conflicts is extremely difficult. However, it is clear that avoiding the "us versus them" paradigm is essential. For an institution such as Partners to work effectively with its faculty and staff the goal must be to align interests. If a patient is injured, both the investigator and the institution will face the public's wrath. We believe that accumulation and use of case experience are critical elements in developing policies that will earn respect from faculty, principal investigators, and patients alike. Developing case experience is a complex and specialized task requiring a large collection of skills - administrative, scientific, managerial, financial, and legal. Basic protections for human subjects have existed for decades in biomedical research. Based on principals laid down three decades ago, healthcare institutions that conduct biomedical research are expected to have every single study protocol reviewed by an institutional review board (IRB). The IRB must meet federally defined expectations for its makeup and its methodology (45 CFR 46). Lay representation as well as scientific expertise is required on the Board. Very careful documentation is necessary to demonstrate that each proposed protocol is carefully reviewed by the Board for the merit of the study, the adequacy of its protection of human subjects, the thoroughness of its procedures for establishing informed consent, the fairness of its recruitment procedures and other factors. Though set up and staffed by the institution, they operate with great independence, and their rulings are not controlled by anyone in the institution's Â

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leadership. The IRB system is generally regarded as having worked well. The details of approval are not micro-managed federally. The process is specified and the outcome is audited and judged. The process has come under fire in recent years because of some highly visible lapses in the performance of IRB's at prominent institutions. Some of these institutions have had their privileges to conduct human research suspended for brief periods of time while they remedied flaws in the constitution or operation of their IRB's. A watershed event was the suspension of privileges at Duke University in May of 1999 - the largest clinical-research program in the country. But these flaws and lapses have not changed the fundamental agreement by almost all parties that the IRB system has made an enormous contribution to increasing the integrity and quality of research with human subjects. Accordingly, the Federal government's efforts in the past two years have been to strengthen the clarity of their expectations, increase their oversight of the process, develop an independent accreditation system, but not to alter the basics.[4] Most of the proposals put forth by critics are for incremental changes of one sort or another, not for radical change. Members of IRBs are typically concerned about the existence of personal financial interests on the part of the Principal Investigator. But the IRB's roles in the disclosure of such interests and in the management of disclosed conflicts have not received systematic attention until very recently. Within the past few years, substantial numbers of the major scientific journals have mandated disclosure of an investigator's relevant financial interests in the outcome of a study reported in a publication.[5] No formal, nationally defined mechanism guides approaches to dealing with financial conflicts in bench, or non-clinical, research. Yet, the Public Health Service, the National Science Foundation, and some major private foundations require investigators to disclose personal financial interests relate to their research. The disclosures are made to the individual's institution, and the institution is expected to "manage" the conflict - a task that leaves much to the imagination of administrators. The methodology and the intensity of that management are undefined, and few useful examples are offered, other than remedying the conflict by divestiture of the financial interest or stopping the research. No mechanism analogous to the IRB, in representing the public interest, is explicitly required; the mechanism of a review committee is suggested as one approach. Characteristics of Conflict of Interest Within this context, what should institutions, as custodians of the public trust do to manage conflicts of interest? To act effectively, it is necessary to understand some characteristics of the issue that are not immediately self-evident. Several important characteristics of conflicts of interests are often overlooked. Problems are always viewed in hindsight. Financial conflicts previously viewed as trivial look terrible after a tragedy has occurred. For example, a human volunteer died during a recent study at the University of Pennsylvania. Both the investigator and the institution had financial interests in the company sponsoring the research. An elaborate Â

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investigation found, in retrospect, that the patient had not meet all of the criteria for enrollment that had been specified in the IRB-approved protocol. Although only one individual died, the tolerance for fatalities in this context is, as previously noted, essentially zero. The lapse in care might have been viewed with more forgiveness had no financial conflict of interest existed. Another point, which researchers themselves tend to overlook, is that individuals generally cannot objectively evaluate their own conflicts of interest. Scientists are not immune to subjective self-assessment despite a strong sense of professional responsibility and objectivity. Public expectations, as moving targets, are another challenge to managing conflicts of interest. Recent concern over inventors receiving a share of royalties from a product represents a new shift in expectations surrounding biomedical research. Historically, royalties were not considered a significant financial conflict of interest if the institution processed them. In fact, most institutional policies require that a fraction of royalties go directly to the inventor for proven successes and innovations. Royalties are relatively modest in most cases. Although rigorous review and verification precede the receipt of royalty income, equity in a company can represent a major windfall even without a product or replicable research. In spite of this key difference, the Association of American University's (AAU) recently proposed guidelines restricting royalties. These AAU guidelines represent the belief that receipt of royalties creates a financial conflict and should be subject to institutional management or should disqualify an investigator from involvement in clinical research that might affect that royalty stream or the company involved.[6] Finally, managing financial conflicts requires the understanding that personal financial conflicts bother the public more than career advancement conflicts of interests. Academic investigators seeking fame are acceptable - but not if they want fortune as well. This unstated but real expectation regarding a researcher's motivation is strongest when a researcher is given the privilege to conduct research on human beings. The one exception, which has been readily accepted for years, is the receipt of royalties processed through the institution, as mentioned above. These characteristics define the context as institutions consider how to manage conflicts. Partners HealthCare System and others would argue that the IRB cannot manage these conflicts of interests.[7] The IRB should instead focus on the scientific protocol proposed and whether the ratio of risk and benefit for the subjects is reasonable. The IRB lacks the expertise to analyze business situations and to weigh whether a financial interest is large or small, volatile or not, closely related to the research outcome or not, and, hence, acceptable or unacceptable. The increasing volume of protocols requiring IRB review already overwhelms the boards. Institutional Review Boards rely on the voluntary efforts of a wide array of members, including community members. Additional workload is not a tactical option, even if it is an appealing theoretical one. A Conflict Review Process Â

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A thoughtfully constituted "conflict-of-interest committee" could serve the review purpose that the IRB cannot - and is not designed - to serve. A conflict-of-interest (COI) committee is, indeed, one of the mechanisms proposed in guidelines drafted by national organizations and agencies. Direct dialogue must be established between any separate conflict-of-interest process and the IRB process. The IRB must be informed of any residual financial conflicts that have not been eliminated by the conflict of interest review process. And the IRB must wrestle with whether adding information about financial conflicts to the informed consent form for patients is useful and appropriate. The difficulty of resolving this ethical dilemma may be the single most powerful argument for elimination of all financial conflicts for studies involving human subjects. An institutional conflict-of-interest review committee must have the kind of autonomy and clout that the Institutional Review Board has. The IRB is set up and staffed by the institution, but it has the ability to act independently and to work directly with the Public Health Service if necessary to revolve an issue. That arms-length independence is central to the strength of the protective process. The IRB has a federal mandate for its grounding. A parallel conflict-of-interest review process or committee has no natural connection with authority which offers that independence and clout. Thus, for effectiveness, the COI committee must have ties to the highest levels within the institution. In the Partners structure, the COI committee reports to the parent corporation's senior management and its Board of Trustees. Trustees are most likely to have the clearest long-range view. Although they may have some conflict of interest from wanting to see the institution's research program and its financial health prosper, they are acutely aware of the damage a scandal could cause to the institution. The COI committee should develop, disseminate and enforce clear institutional standards. General guidelines, in our experience, do not work. Nor do simplistic and arbitrary rules. These rules fail to earn the respect of faculty. The staff should handle analysis and mediation of conflict cases that fall into the acceptable or unacceptable categories. The COI committee must be available to review Specific cases that fall in the gray zone of existing policy should go to the COI committee, which will make the hard judgements and modify policy when necessary. An appeal process should be available to faculty, if they feel their arguments were misunderstood. Utilization of that mechanism, with personal appearance before the committee, has been rare in our experience, and thus does not add significant workload, but its availability adds substantially to the credibility of the process. One assumption runs through this article and all of the publications and proposals on this topic. This assumption is that the institution can rely on the personal disclosures that faculty make under institutional or journal policy. Yet, disclosures may not be complete. Â

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They may not be honest. They may be tilted toward incompleteness by splitting hairs, perhaps where an unwritten commitment of money or stock exists in the background, without a written agreement. As a practical matter, there is nothing that an institution can do to verify the completeness of disclosures. Stock options in companies which are not publicly held are not discernible with any administrative search. Consulting agreements, written or unwritten, are generally private as well. And unwritten understandings are inaccessible. The institution make clear, in the most potent terms, that full disclosure is required and must be signed by the faculty members as a matter of professional responsibility. Anything beyond trivially explained errors that later emerge must be treated as dishonest acts. Sanctions must be available and employed in those rare situations for a policy to have significance. Yet, as a General Accounting Office review indicates, the use of sanctions has been extremely rare.[3] Areas of Consensus Harvard Medical School has long been considered extremely conservative because of its prohibition of all financial interests in clinical trials. Currently, many institutions and opinion leaders across the country are moving towards that conservative position. It is certainly not yet a universal policy but it is the direction in which institutions are moving after seeing how scandals involving a few subjects destroyed public trust. That trend raises special issues, specifically with respect to medical-device studies, where involvement of the inventor may be needed in some way in the clinical trial. Innovative approaches are needed to deal with that area. Even in bench research, which does not directly involve human subjects, equity (stock or stock option) interests in one's research sponsor are sensitive. The reason for that is simple. It is possible for hype, whether justified or not by the research, to inflate the value of the stock of a company even with no product yet in sight. Any fraction of that equity increase can have enormous dollar value to a researcher. That volatility in value is the underlying reason behind the additional feature of in the current Harvard Medical School policy: equity holdings are not allowable for bench research. Other financial interests such as consulting income are allowed, but not equity. There is no national consensus on whether they should be disallowed in all institutions or whether, conversely, the Harvard policy should be liberalized to allow them. The consensus is simply that this is a sensitive area that requires thoughtful treatment. A level playing field would be desirable, amongst institutions, with respect to policies affecting faculty members' involvement with industry as well as competition amongst institutions for recruitment of faculty. Any unacceptable conflicts must be eliminated promptly. Allowing a study to begin under a cloud of the conflict only complicates matters. The final point of consensus is that any significant conflicts which have not been eliminated must be disclosed to the reader of a manuscript. Journals are requiring this more uniformly, additional institutional policies are requiring this, and ultimately the patients expect this.[5] If disclosures are required to the institution on a calendar cycle Â

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then any subsequent changes in the facts of any relevant situation will be reported promptly. If investigators were allowed to begin a study with no financial interest and then allowed to later acquire a financial interest without reporting that change, it would mock the routine mandatory disclosure system. In short, episodic disclosure in the event of any change of circumstances is essential. In summary, progress toward consensus on at least some core principles has occurred within the last few years. Principles exist; accepted or validated methodologies do not. Sharing the experience of those institutions which have had operative mechanisms will advance the national debate beyond the philosophical level. It may lead to nationally accepted methodologies which command respect of both faculty and patients. If we can create a nationally consistent mechanism for processing conflict-of-interest situations, and approximate the under-appreciated success of the IRB process for protecting human subjects, we will have done a good thing. Ronald Newbower, Ph.D., is the Vice President for Research Management for the Partners HealthCare System. He also serves as Senior Vice President for Research and Technology at Massachusetts General Hospital and as Associate Professor at Harvard Medical School and Harvard-MIT Division of Health Sciences and Technology.

Endnotes 1. Lo, B., Wolf, L.E., Berkeley, A. "Conflict-of-Interest Policies for Investigators in Clinical Trials." New England Journal of Medicine, 2000. 343:1616-1620. 2. Martin, J, Kasper, D. "In Whose Best Interest? Breaching the Academic-Industrial Wall." New England Journal of Medicine, 2000. 343:1646-1649. 3. United States General Accounting Office. "HHS Directions Needed to Address Financial Conflicts of Interest." November, 2001. 4. Koski, G. "Risks, Benefits, and Conflicts of Interest in Human Research: Ethical Evolution in the Changing World of Science." Journal of Law, Medicine & Ethics, 2000. 28:330-331 5. Van McCrary, S, Anderson, C, Jakovljevic, J, Khan, R, McCullough, L, Wray, N, Brody, B. "A National Survey of Policies on Disclosure of Conflicts of Interest in Biomedical Research." New England Journal of Medicine, 2000. 343:1621-1626. 6. Association of American Universities Task Force on Research Accountability. "Report on Individual and Institutional Financial Conflict of Interest." October, 2001. 7. Association of American Medical Colleges Task Force on Financial Conflicts of Interest in Clinical Research. "Protecting Subjects, Preserving Trust, Promoting Progress - Policy and Guidelines for the Oversight of Individual Financial Interests in Human Subjects Research ." December, 2001.

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References Gilijns, A, Thier, S. "Medical Innovation and Institutional Interdependence - Rethinking University-Industry Connections". Journal of the AMA, 2002. 287:72-77. Morin, K., Rakatansky, H., Riddick, R, Morse, L, O'Bannon, J, Goldrich, M., Ray, P, Weiss, M, Sade, R, Spillman, M. "Managing Conflicts of Interest in the Conduct of Clinical Trials". Journal of the AMA, 2002. 287:78-84.

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In focus Long-Term Care: Lessons from the United Kingdom, Germany, and Japan Tomoko Shinoda-Tagawa, MD, MPH and Soichi Koike, MD, MPH [Editorâ€™s Note: We apologize that figures and tables for this article are currently unavailable. We hope to resolve this soon.] The populations of industrialized nations are aging faster than they have ever been.[1] The need to provide care for a growing population of elderly people is an urgent problem in most industrialized countries.[2] However, there is no definite answer as to what kind of long-term care system works best for meeting the increasing needs of the elderly. An international comparison of long-term care systems for the elderly provides useful lessons for any country developing its own such policy. Here, we examine three industrialized countries - the United Kingdom (UK), Germany, and Japan - that have had universal healthcare systems and have recently struggled to implement new policies for increasing public, long-term care. Since the demand for long-term care will increase significantly in many countries in the next quarter- to half-century,[1,2] the healthcare experiences of those nations that have already worked with a large elderly population provide useful insights. In this article, our definition of long-term care includes both institutional care (e.g., nursing home, residential care home, rest house, and geriatric hospital) and community-based care (e.g., nursing care in the community, home care, day care, temporary respite stay, and assistive devices like grab rails or wheel chairs). We will first explain the nature of care for the elderly in terms of how it differs from care for other age groups. Secondly, we will describe the long-term care systems for the elderly in these countries. Finally, we will identify common challenges and lessons that other countries can learn from their examples. The Nature of Care for the Elderly Care for the elderly differs from care for other age groups in several important ways. Both community-based care and institutional care play especially substantial roles. Given the often complex and multifaceted needs of the elderly, reliable coordination among different types of care - physicians offices, hospitals, nursing homes, residential care facilities, and home care in the community - is particularly essential for successful, longterm care. Additionally, care for the elderly depends heavily on informal, unpaid care by families, relatives, friends, and neighbors as both a supplement to, and substitute for, formal paid care.[1,3,4] Long-Term Care Systems in the UK, Germany, and Japan An Overview of Long-term Care Systems in These Countries

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Universal, long-term care coverage, based on the principle of social equity, is a primary policy goal for the UK, Germany, and Japan. Long-term care in these countries was historically financed through taxes, and provided for mainly by local governments through a means-tested welfare mechanism. This welfare system, however, only offers benefits to the most needy subscribers. To deal with both demand increase by aging populations and the cost of this care, all three countries have implemented new policies over the last decade. In Germany and Japan, social insurance programs for long-term care were introduced in 1994 and 2000, respectively. In the UK, following a report by the Royal Commission on Long Term Care, a new kind of organization to provide integrated services was planned.[5] Long-term care in the UK, Germany, and Japan is now financed by either taxes or by social insurance premiums, as outlined in Table 1. Long-term care programs in these countries cover both institutional care and community-based care. The German program also provides a cash benefit as part of its community-based care component. Beneficiaries are required to contribute to the programs financially, either through "spend-down," premium payment, or co-payment.[3] To make community-based care more accessible, programs use various facilitation mechanisms like capitation-based payments to integrated care organizations, cash benefits for community-based care, and service provisions for elderly persons with relatively mild disabilities. Background Data on the UK, Germany, and Japan International trends in the percentage of select countries' populations over 65 years of age are shown in Table 2. In all four countries including the US, the proportion of the population aged 65 and older will be about 1/5 to 1/4 of each country's total population in 2025. Japan houses both the world's highest percentage of elderly people, and the most rapidly-growing population of this age subset, and the population percentage aged 80 and over in both Japan and Germany is expected to double in 25 years from now. Background data for demography and healthcare expenditure are shown in Table 3. In all three countries, public long-term care expenditures currently consist of about 1% of GDP (Table 4). Within publicly-financed long-term care, the proportion of publiclyfinanced institutional care and community-based care varies among nations. The United Kingdom (UK) The long-term care system in the UK is currently in transition. Long-term care for elderly people is provided mainly by Departments of Social Services in local governments, after the application of a means-test. Following this assessment, eligible individuals are provided with a package of care.[6] Services provided by local governments are called "social care" or "social services," and include institutional care (in either nursing homes or residential homes), and community-based care (e.g., home care services and personal assistance such as lifting, washing and bathing, food delivery, rehabilitation service, adult day care in centers, assistive devices, and nursing care).[7,8] The National Health Service (NHS) also covers some geriatric hospital units and nursing care in the community.[3] Social care in the UK is financed through general revenue. However, after the Â

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implementation of the NHS and Community Care Act of 1990, anyone with assets in excess of GBP 10,000 (USD 16,000) is required to contribute to the costs of institutional care, and anyone with assets in excess of GBP 16,000 (USD 25,600) is required to meet the cost in full.[6,9] In practice, however, local authority has some discretion over how much people have to share the cost of care, resulting in a large variation among local councils.[3,6,11] After the Labor Government was instated in 1996, the UK transformed its principle of health policy into what is called the "new partnership."[12] The Report of the Royal Commission on Long Term Care of 1999 recommended that the costs of care should be split between living costs and personal care categories.[5] In the near future, nursing care will be available for free after an assessment according to need, while living costs will be subject to a co-payment of older people based on their means. The Health Care Act of 1999 allowed the NHS and Departments of Social Services in local governments to work more closely.[10] They were allowed to pool budgets, delegate responsibilities to each other, and merge services to deliver coordinated care.[11] In the future, new organizations called "Care Trusts" will hold the full health service budget for patients, and will provide integrated services of medical and so-cial care for their enrolled patients.[11] A capitation mechanism is expected to provide the incentive for Care Trusts to deliver adequate rehabilitation services, increase community equipment services (assistive technology like grab rails, pressure relief mattresses, and fall alarms), and provide emergency care for people at home while preventing unnecessary hospital admissions.[11] Germany Long-term care in Germany has been provided through compulsory social insurance programs for people of all ages, regardless of the individual's financial status, since 1994.[13] This social insurance program for long-term care is financed solely through premiums, without general revenue. Collected premiums are pooled and redistributed depending on need under this system. Germany's long-term care program provides older people with either institutional care or community-based care depending on an individual's functional status. If eligible individuals choose community-based care, they have the option of either a cash benefit or a service benefit, which serve as an income supplement or voucher, respectively.[13] The German long-term care insurance program is administered by "sickness funds," which are also insurers of medical insurance programs, and are financed by an employment-based premium. Employees and their employers jointly pay for the premium, fixed at 1.7% of monthly gross income (0.85% each).[14] Retirees pay half of the premium, while the other half is paid by pension funds. Total expenditure for longterm care has been increasing since the program was introduced in 1994, and cost DM 31 billion (USD 15.5 billion) in 1998. Of this DM 31 billion, 44% was spent for institutional care, 51% for community-based care (27% for cash benefit, 13% for home service benefit, 8% for respite care and pension contribution for caregivers, 2% for assistive devices, 1% for day care), and 5% for administrative costs.[13] Of the 1.8 million beneficiaries of the long-term care program, 54% chose a cash benefit, 25% chose an institutional service benefit, 8% chose a home care service benefit, and 10% chose a combination of a home care service and cash benefit.[13] Â

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One of the challenges for the German program is coordination of care; the social insurance program itself does not have an official "care manager." Instead, beneficiaries are responsible for choosing the care they think they need.[13] However, for the elderly with dementia, a legal program called "Adult Guardianship for the Cognitively Impaired" plays an important role in coordinating necessary care.[15] The guardianship program includes coordination of the necessary support, such as administration of property, housing, and general supervision in daily life for cognitively impaired adults. In short, the most vulnerable population receives coordinated care from the system, while others are responsible for making their own decisions. In this respect, the German system seems to search for the right balance between social support and consumer choice. Japan Japan introduced a compulsory social insurance program for long-term care in 2000. Japan's former welfare program gave priority to individuals with low incomes and those without family caregivers. As a result, long-term care was not usually available for elderly people if they had family caregivers with middle or high income, and medical care was often provided as a substitute for long-term care for elderly - even for those who didnt need much medical supervision (a.k.a., "social admissions").[15,16,17] The current long-term care insurance (LTCI) program provides older people either institutional care (e.g., nursing homes, health facilities for the elderly, and designated long-term-care beds in hospitals), or community-based care (e.g., visiting nurse care, housekeeping services, bath service, rehabilitation, and loan of welfare devices like wheelchairs). Eligibility for benefits is based solely on an applicants physical and mental condition through eligibility assessment, performed by municipalities.[17] In order to help the elderly remain in the community as long as possible, the Japanese program covers home care services for those with relatively mild disabilities whose eligibility criteria is deemed "assistance required."[17] The Japanese LTCI program is financed through a combination of social insurance premiums and taxes. Half of the funding comes from two kinds of new premiums: (1) people aged 40-64 pay a supplement to their health insurance premium; and (2) people aged over 65 pay a premium deducted from their public pension, depending on their income. The other half of funding comes from general revenue, 50% of which comes from national revenue, 25% from prefectures, and another 25% from municipalities. Maximum monthly benefits for an eligible beneficiary of the long-term care program vary depending on the disability level and the setting of care (in the community vs. in institutions). Beneficiaries are required to pay a co-payment, which is 10% of the benefit. It is estimated that in 2000, 30% of Japanese expenditure on this program was used for care in the community setting, and 70% was used for institutional care.[18] Among the program's 1.9 million beneficiaries, 32% were provided institutional care and 68% were provided community-based care.[19] The Japanese program includes a care manager to coordinate necessary care for beneficiaries. Care managers are paid JPY 6500-8400 (USD 50-65) per month per beneficiary as a care management fee (depending on the beneficiary's care need rank), for which the beneficiary is not required to provide a co-payment. Individuals who want to make a care plan on their own can choose to do so. Some experts are concerned that care Â

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plans developed by provider employees may not be based solely on the needs of beneficiaries, but on the interests of providers.[15,17] How the LTCI program may assure quality care management is currently being debated. Common Challenges and Their Lessons Coordinating acute care and long-term care A care-management mechanism providing both acute and long-term care in a wellbalanced manner is indispensable for elderly people. The elderly often need a combination of these care types because of the nature of aging. However, coordination between the two care types is difficult, particularly because of the unclear boundary between acute and long-term care. Furthermore, care for elderly people is affected by various kinds of non-medical factors like living arrangement, income, and family, especially for elderly people with physical and/or mental disabilities. Lastly, care coordination should be matched with an individual's preference. Thus, reliable coordination between acute and long-term care requires that various healthcare professionals remain involved in care for the elderly, while beneficiaries themselves alter their perspectives on care. Preventing cost shifts between acute care and long-term care Due to the indefinite boundary between medical care and social services in long-term care settings, patients may be inappropriately treated in the medical care sector, and cost shifting between medical care programs and social service programs may occur. In the three aforementioned countries, local authorities were responsible for long-term care, which generally resulted in such inconsistencies among available services and in cost sharing among localities or states. In the UK, the NHS and departments of social services in local governments have begun to hold a joint budget and work together.[11] Thus, cost-shifting is prevented, resulting in a lower consumer cost of acute care services that allows the NHS to provide patients free medical care while simultaneously bearing the cost of social care.[3] Before that reform, patients may have resisted transfer to nursing homes, residential care homes, or community settings, due to their reluctance to pay for such provisions. In Germany, because of the lack of a care manager, the potential cost shifting between the medical insurance program and the long-term care insurance program has not been solved.[13] Japan, where most institutionalized care has been traditionally paid for by the medical insurance program,[17] is still struggling to develop ways to clearly differentiate the roles of acute and long-term care, although it has established a new social insurance program for long-term care. Supporting the informal caregivers Generating increased support for informal caregivers is a common challenge for Germany, Japan, and the UK. Germany created a cash benefit as a part of the communitybased service component of its social insurance program, based on the assumption that most of the elderly give at least some of the cash benefit to their informal caregivers. In contrast, the Japanese program does not include cash benefits, partly because such Â

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benefits might bind families to informal care-giving. The UK government plans to generate informal caregiver support by increasing the types of social services for caregivers, like night-sitting services, adult day care in centers, and respiratory care.[7,8] Assuring quality care Quality assurance in long-term care has been challenging for the programs established in each of these three countries.[3] Elderly people comprise one of the most vulnerable populations, since they are prone to physical disability and cognitive impairment. Traditionally, quality assurance mechanisms for the elderly focused mainly on structural issues such as building and staffing requirements. Since each country is now putting emphasis on community-based care, developing quality assurance mechanisms for this sort of care is an important priority, and is just getting started.[3] At this point, each country is trying to standardize care at the national level. The UK has made the greatest progress in this area, as its National Institute for Clinical Excellence organized the National Service Framework for Older People in late 2000, which aimed to establish clear service standards for the elderly.[20] Setting up quality assurance schemes for home care is still challenging these countries, and is under current debate.[3,13] In the UK, the new National Care Standards Commission planned to start working on home care standards with the turn of this new year, 2002.[11] Conclusion As the percentage of the elderly population increases rapidly all over the world, individual nations must establish their own long-term care systems. The introduction of social insurance programs in two of the three countries mentioned in this article (Germany and Japan) was based on the realization that the provision of care should be founded on an individual's functional status, rather than his financial or family status. All three countries have attempted to establish long term-care through universal coverage by either taxation or social insurance programs. While the UK, Germany, and Japan have taken different routes to meet the needs of their older people, they share the characteristic of emphasizing community-based care to assure independent living with dignity and autonomy, and other developed nations may learn from their experiences. Acknowledgements We thank Deb Azrael, PhD, for valuable comments and careful reading of this manuscript. We also thank Nancy Turnbull, Lecturer of Harvard School of Public Health, Department of Health Policy and Management, and Yoshinori Hiroi, Associate Professor of Chiba University Faculty of Law and Economics, for their valuable comments and suggestions. Tomoko Shinoda-Tagawa, MD, MPH is a Master of Science student in the Department of Health Policy and Management, Harvard School of Public Health. Soichi Koike, MD, MPH works for the Ministry of Health, Labor, and Welfare in Japan.

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References 1. Anderson GF, Hussey PS. "Population Aging: A Comparison Among Industrialized Countries." Health Affairs, 2000, 19(3): 191-203. 2. Jacobzone S. "Coping with Aging: International Challenges."Health Affairs, 2000, 19(3): 213-225. 3. Merlis M. "Caring for the Frail Elderly: An International Review ."Health Affairs, 2000, 19(3): 141-149. 4. Feder J, Komisar H, Niefeld M. "Long-Term Care in the U.S.: An Overview." Health Affairs, 2000. 19(3): 40-56. 5. The Royal Commission on Long Term Care. "With Respect to Old Age: Long Term Care - Rights and Responsibilities," 1999. 6. European Observatory on Health Care Systems. "Health Care Systems in Transition, the United Kingdom," 1999. 7. Department of Health. "Better Care, Higher Standards: A Charter for Long-Term Care," http://www.doh.gov.uk/longtermcare/ 8. The Department of Health. "Modernizing Social Services: Promoting Independence, Improving Protection, Raising Standard," 1998. http://www.doh.gov.uk/scg/pop.htm 9. Wistow G. "Decentralization from Acute to Home Care Settings in England." Health Policy 41 Supplement, 1997, S91-S108 10. Health Act 1999 Sections 29 and 30 - New Guidancehttp://www.doh.gov.uk/jointunit/28a28bb.htm 11. The NHS Plan http://www.nhs.uk/nationalplan/,http://www.nhs.uk/nationalplan/nhsplan.pdf 12. The White Paper, The New NHS: Modern Dependablehttp://www.officialdocuments.co.uk/document/doh/newnhs/contents.htm 13. Cuellar AE, Wiener JM. "Can Social Insurance for Long-term Care Work? The Experience of Germany." Health Affairs, 2000, 19(3): 8-25. 14. European Observatory on Health Care Systems. "Health Care Systems in Transition, Germany," 2000http://www.who.dk/DOCUMENT/e68952.pdf 15. Hiroi Y. "Medical Care and Social Services." Care-Gaku (Tokyo: Igaku-Shoin), 2000, 184-222 (in Japanese).

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16. Council on Elderly Health and Welfare, Ministry of Health and Welfare, Japan. "The Interim Report on Establishment of New Long-Term Care System," July 26, 1995 (in Japanese). 17. Cambell JC, Ikegami N. "Long-Term Care Insurance Comes to Japan." Health Affairs, 2000: 19(3): 26-27. 18. Ministry of Health and Welfare. "29th Joint subcommittee on Health and Welfare for the Elderly and Payment Systems for Long-term Care Insurance, Council on Medical Insurance and Welfare for the Elderly," November 1, 2000 (in Japanese). 19. Ministry of Health and Welfare. "Meeting for Local Government Officials in Charge of long-Term Care Insurance," May 28, 2001 (in Japanese). 20. National Service Framework for Older Peoplehttp://www.doh.gov.uk/nsf/olderpeople.htm 21. Saltman RB. "The Context for Health Reform in the United Kingdom, Sweden, Germany, and United States." Health Policy 41 Supplement, 1997, S9-S26.

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Unfamiliar Regulatory Risks: Lessons to be Learned from Federal Regulation of Human Cloning J. Martin Shanahan, CPA, JD In July 1996, a sheep named "Dolly" was born in Scotland as a monumental result of cloning technology.[1] In March 2001, a scientist affiliated with the "Raelian Religion," described by many as a cult, testified before a Congressional Committee that he intends to move forward with plans to clone a dead, 10-month-old boy.[2] In January 2001, Advanced Cell Technologies, a Worcester, Massachusetts biotechnology firm, announced the birth of the first animal from a cloned, endangered species.[3] In November 2001, Advanced Cell Technologies announced successful human somatic cell nuclear transfer (cloning) and pathogenesis.[4] Throughout the hearings, members of Congress criticized officials from the United States Food and Drug Administration (FDA) for doing "too little, too late to regulate the quickly-evolving field of cloning research."[5] This comment reflects a critical sentiment that modern rulemaking by federal regulatory agencies is slow-moving, cumbersome, and inefficient. Nevertheless, the modern system of government regulation in the United States has certainly evolved over the past two hundred years, and government action has established methodical and predicable methods for regulatory agencies to promulgate rules. These regulatory procedures are affecting the implementation of a legal framework to govern human cloning. Investigating the policies of the current cloning debate, along with the governmental structures framing it, may elucidate and guide future paths of action. Moreover, lessons learned from the problems encountered by regulators in the cloning debate may someday be applied to other areas of emerging technology and uncertain risk, like global warming, bioterrorism, and Internet regulation. Current Regulatory Framework The United States federal government and its federal agencies enjoy limited and enumerated powers. Through representatives in Congress, the people pass laws to memorialize their will. As our republic has become more complex over the past two centuries, Congress has generally taken responsibility for administrative lawmaking at the macro, or "big picture" level, while delegating micro-level rulemaking authority to the executive and judicial branches. Reasoning for this Congressional delegation of power is twofold. First, the 435 members of the House of Representatives and 100 members of Senate would have great difficulty agreeing on something as complex as cloning human beings. Second, a specialized agency (like the FDA) is more likely to develop fair rules in scientifically complex arenas like genomics, genetic engineering, and human cloning technology. An important principle of American administrative and constitutional law is that an agency receives only the authority that it is legislatively delegated. If an agency acts outside the statutory "box" created by Congress, its actions are deemed unconstitutional Â

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by violation of the Doctrine of Ultra Vires.[6] In this doctrine, the Supreme Court stipulates that "When Congress passes an Act empowering an agency to carry on governmental activities, the power of that agency is expressly limited by the authority granted."[7] While Ultra Vires allows Congress to grant a modicum of agency to institutions like the FDA, an excessively broad grant of rulemaking authority is equally unconstitutional, by violation of the Non-Delegation Doctrine. Under this doctrine, the U.S. Constitution states that "all legislative power herein granted shall be vested in a Congress."[8] The U.S. Supreme Court has construed this statement to formulate the following interpretation: "That Congress cannot delegate legislative power is a principle universally recognized as vital to the integrity and maintenance of the system of government ordained by the constitution."[9] Consequently, for regulatory action like human cloning technology to be upheld as constitutional, it must be carefully crafted to fall within a "box" constructed from a limited grant of authority. Furthermore, the Administrative Procedure Act (APA) of 1946 outlines Congressional procedure requiring regulators to adhere to rulemaking authority. To change or add a rule, an agency like the FDA must: (1) issue a notice of proposed rulemaking; (2) publish the proposed rule in the Federal Register; (3) give the public time to comment in writing on the proposed rule; (4) read and consider each and every written comment concerning the proposed rule; (5) revise the proposed rule accordingly; and (6) publish regulation based on the proposed rule in the Federal Register, where it becomes final. The Supreme Court may strike down government action that violates the Doctrine of Ultra Vires, Non-Delegation Doctrine, or the APA. Review court standards hold unlawful, and set aside agency action, findings and conclusions that they deem: (1) arbitrary, capricious, or an abuse of discretion; (2) contrary to the Constitution; (3) in excess of statutory jurisdiction; and (4) without observance of procedure required by law.[10] Thus, lawful regulation requires that Congress delegate limited rulemaking and enforcement authority.[11] Existing Federal Regulations of Cloning Technology The FDA has authority to regulate medical products including drugs, procedures, and devices. The use of cloning technology to clone a human being would be subject to both the biologics provisions of the Public Health Service Act, and to the drug and device provisions of the Federal Food, Drug, and Cosmetic Act.[12] Existing FDA regulations merely outline the FDA's authority and define standard procedure. As an example, a recent regulation, published as a note in the Federal Register on October 14, 1993, stated the FDA's statutory authority over human somatic cell therapy and gene therapy products (human cloning technology).[13] This ordinance served as a notice that Congress had delegated rulemaking authority to the FDA, but did not impose an outright ban. Similarly, in March 1997, the FDA proposed additional regulations concerning somatic cell therapy products, requiring that researchers disclose cloning plans to the FDA and request approval for their research. Many people recognize Â

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that a requirement of FDA approval does not result in any bans on human cloning and feel that additional federal intervention is necessary.[14] Under former president Bill Clinton's administration, Congress imposed a ban on federal funding for research in human cloning technology.[15] The federal ban declared that any institution receiving direct or indirect federal funds would be forced to forfeit federal financial support if found engaging in human cloning technology research.[16] Since this research moratorium, neither the FDA nor the Department of Health and Human Services has reported violations of the ban. In addition to this regulation, President Clinton established the National Bioethics Advisory Commission to study and make recommendations in the area of genomics and human cloning technology.[17] Constitutional Limitations Without Further Congressional Action Traditionally, the American government assumes freedom of action in the absence of specific, justifiable prohibitions.[18] This tradition is enshrined in the constitutional language of liberty used in case law, ranging from freedom of unreasonable search and seizures to an individual's freedom to refuse medical treatment. Regulatory agencies like the FDA may not lawfully impose rules, levy fines, or impose criminal penalties in the absence of congressionally granted rulemaking or enforcement authority. Unilateral FDA action, without a specific grant of rulemaking or enforcement authority from Congress, would be unconstitutional. If the FDA were to outlaw human cloning based on its broad statutory authority to regulate "medical products, including drugs, procedures and devices," the Supreme Court could strike down that action under Ultra Vires, based on the FDA's assumption of "Congressional authority."[19] Similarly, if Congress passed legislation to regulate any and all medical products, (including drugs, procedures and devices), that action would be equally invalid for violation of the NonDelegation Doctrine. The Supreme Court would interpret any such actions circumventing current safeguards as those of a "tyrannical government [where] the right of making and enforcing the laws is vested in one and the same body of men."[20] Therefore, in order for the FDA to prohibit human cloning, Congress must forge a new path of action. The National Bioethics Advisory Commission has proposed that legislation should extend human subjects protection and ban somatic cell nuclear transfer to produce a human being. With this counsel in mind, and in absence of Congressional action, the FDA is left with two options: (1) to continue the moratorium on the use of federal funding for the creation of a human using somatic nuclear transfer; or (2) to appeal to the private sector for adherence to the intent of federal moratorium on cloning human beings. General Recommendations for Regulators in Areas of Unknown Risks While finding appropriate methods to restrict human cloning technology, regulators must not circumvent lawful procedure. The U.S. Supreme Court has a long history of invalidating government action it deems unconstitutional, and federal regulation of human cloning will not serve its purpose if they are subsequently nullified. Lawmakers in Â

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the FDA and Congress must carefully craft legislation that will stand the test of time. On the other hand, it is advisable that resultant legislation include a sunset provision, so that Congress can reexamine issues at a later date. The National Bioethics Advisory Commission recommends that, "as scientific information accumulates and public discussion continues, we as a society need to retain the flexibility to adjust our course... A sunset provision would dictate that the prohibition would expire and that a review body [could examine the issue further]."[21] Several general lessons may be gleaned from the FDA's experience regarding the technology used to clone human beings. For all regulators, gathering intelligence to identify areas of potential risk is absolutely imperative. Similarly, if regulators determine areas of risk to be valid, they must work with Congress to educate and discuss policy implications from the onset. Additionally, policy regulators should work carefully with Congress to craft appropriate legislation within the strict boundaries of Constitutional law. Finally, they should revisit their decisions over time and modify them in accordance with changing historical contexts. J. Martin Shanahan, CPA, JD is pursing an MPH degree at the Harvard School of Public Health, and works as a federal investigator for the United States Department of Labor.

References 1. West R. "Scientists Testify on Human Cloning Plans." The Washington Post, March 29, 2001, A: 10. 2. "Proposed Regulation of Human Cloning Technology": Hearing Before the House Committee on Energy and Commerce, Subcommittee on Oversights and Investigations, March 28, 2001[Testimony of Kathryn Zoon, Ph.D.] Dated March 28, 2001. Note: Other members of the Raelian Religion testified that they believe that life on Earth was created through genetic engineering by extraterrestrials. 3. Advanced Cell Technology Press Release: "Advanced Cell Technologies Announces Birth of First Cloned Endangered Species - Noah is Born," dated January 12, 2001. 4. Advanced Cell Technology Press Release: "Advanced Cell Technologies Reports Publication of Results of Human Somatic Cell Nuclear Transfer and Pathogenesis," dated November 25, 2001. A somatic cell is any cell except egg or sperm cells. In normal reproduction involving mammals, an egg or sperm contains half the number of chromosomes. A somatic cell contains all chromosomes. Cloning, or somatic cell nuclear transfer, involves removing the nucleus from a human egg and fusing the baron egg with a somatic cell. 5. "Proposed Regulation of Human Cloning Technology": Hearing Before the House Committee on Energy and Commerce, Subcommittee on Oversights and Investigations, March 28, 2001[Testimony of Kathryn Zoon, Ph.D.]

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6. See similar example: Ferry S. "Environmental Law and Regulation." Aspen Law and Business, 1997, 29. 7. Stark v. Wickard, 321 U.S. 288, 309 (1944). 8. U.S. Constitution, Article I, Section I. 9. Field v. Clark, 143 U.S. 649, 692 (1892). 10. Louis Jaffe, Administrative Law Cases and Materials, 39 (1998). 11. Government action violated Ultra Vires Doctrine in Immigration and Naturalization Service v. Chadha, 462 U.S. 919, 944 (1983). The Department of Transportation's decision to rescind regulations concerning "passive restraint regulation in automobiles" was declared unconstitutional based on an "arbitrary and capricious" standard under the Ultra Vires Doctrine, Motor Vehicle Manufactures Association v. State Farm, 103 U.S. 2856, 2857 (1983). Similarly, the Department of Transportation's action of constructing a highway through Memphis, Tennessee (thus necessitating the demolition of Overton Park), as "arbitrary and capricious" and thus violated the Ultra Vires Doctrine in Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 420 (1971). As additional examples, the Environmental Protection Agency could not implement the costs of promulgating regulations because their legislation never specified such criterion. (For more information, see Christine Todd Whitman, Administrator of the Environmental Protection Agency, et al. v. American Trucking Association, et al., 175. F.3rd 4, 5, 2001). The Supreme Court also declared the Line Item Veto Act as unconstitutional under the Non-Delegation Doctrine, for the Veto Act delegated too much authority to the President. In this case, the court stated, "In all tyrannical governments, the supreme majesty, or the right of both making and enforcing laws, is vested in one in the same man, or one in the same body of men." For more information on this case, see City of New York, et al. v. William Jefferson Clinton, et al., 985 F. Supp. 168, 170 (1998). 12. National Bioethics Advisory Commission Publication, VI: Report and Recommendations, June 1997. See also Federal Register, 58 FR 53248, October 14, 1993. 13. Federal Register, 58 FR 53248, October 14, 1993. 14. West R. "Scientist Testify on Human Cloning Plans." The Washington Post, March 29, 2001, A: 10. 15. White House Press Release, March 4, 1997; and House Committee on Energy and Commerce, Subcommittee on Oversights and Investigations, Statement of Kathryn Zoon, Ph.D., Dated March 28, 2001. 16. "Proposed Regulation of Human Cloning Technology": Hearing Before the House

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Committee on Energy and Commerce, Subcommittee on Oversights and Investigations, Dated May 8, 1997. [Testimony of William F. Raub, Ph.D., Deputy Assistant Secretary for Science Policy, Office of the Secretary, U.S. Department of Health and Human Services]. 17. Ibid. 18. National Bioethics Advisory Commission Publication, "Volume I: Report and Recommendations," June 1997. See also Federal Register, 58 FR 53248, October 14, 1993. 19. Christine Todd Whitman, Administrator of the Environmental Protection Agency, et al. v. American Trucking Association, et al., 175 F.3rd 4, 5, (2001). 20. City of New York, et al. v. William Jefferson Clinton, et al., 985 F. Supp. 168, 170 (1998). 21. National Bioethics Advisory Commission Publication, "Volume I: Report and Recommendations, June 1997, Page 101. 22. Sparrow M. The Regulatory Craft: Controlling Risks, Solving Problems, and Managing Compliance. Washington, D.C: Brookings Press, 2000.

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Can Managed Care Consumers Make Informed Decisions? Michael Housman [Editorâ€™s Note: We apologize that the appendices for this paper are not available. We hope to resolve this soon.] Over the past two decades, the idea of competition in the healthcare market has gained momentum. Relying on traditional microeconomic principles, healthcare plans compete for cost and quality while consumers subscribe to, and provide revenue for, those providing the highest quality at the lowest price. This competition is a purchasing strategy whose goal is to obtain maximum value for employers and consumers. However, the strategy is not based on the mere hope that the market will somehow generate better models of care; it is based on demonstrations of successful, high-quality, cost-effective, and organized systems of care that have existed for years. Healthcare competition relies on the assumption that informed consumers can evaluate health plans on the basis of both cost and factors like provider choice, covered benefits, quality, patient satisfaction indicators, and convenience. When consumers neglect these factors, plans may compete on cost alone, thus granting plans and providers a strong incentive to skimp on the health care provided to their enrolled populations. With the shift in the healthcare market from fee-for-service indemnity plans to managed care organizations, consumers have been presented with an entirely different set of variables upon which to base their enrollment decisions. Previously, plans varied in their levels of financial protection from the costs of medical care, which involved premiums, deductibles, co-payments, and out-of-pocket maximums. Thus choosing a health plan traditionally meant determining the arrangement that best protected an individual from financial loss in the event that health care was needed. With the emergence of managed care, the finance and delivery of health care were combined into one package, and restrictions were placed on provider choice and care access. Thus, health plan choice is no longer simply a matter of selecting a system for financing medical care; instead, the decision now involves choosing one's own providers and care delivery system. Therefore, consumers must understand the varying characteristics of the plans from which they are to choose, in addition to possessing an adequate knowledge of managed care and the financing mechanisms that differentiate it from traditional fee-forservice indemnity insurance. Several studies have been conducted measuring consumers' knowledge of the healthcare market and the sort of information that facilitates their decision-making process. In 1981, Joseph Newhouse et al., sought to measure consumer sophistication about the healthcare delivery system on the assumption that more knowledgeable and sophisticated consumers will make better choices.[1] They created a 10-item questionnaire in which subjects were given statements and responded whether they "agree," "disagree," or "don't know." Researchers were able to reject the extreme point of view that consumers are totally ignorant when it comes to healthcare services, since well over half of the respondents answered five questions correctly. The study concluded that consumers have at least a modicum of knowledge about the delivery system and display Â

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more sophistication in discerning a physician's opinion than in choosing a physician in the first place. Another study, conducted in 1993 by Deborah Garnick et al., determined how well Americans understand their health coverage.[2] After asking consumers which services are covered by their health insurance plans, Garnick compared her data to national statistics on the number of workers covered by specified benefits, collected by surveying employers or reviewing benefit plans. After conducting the survey, researchers concluded that consumers are knowledgeable about certain aspects of their insurance coverage but uninformed about others. More specifically, while almost all privately-insured Americans understand a basic element of their insurance plan - that they have coverage for hospital care and physician visits - they underestimate their coverage for mental health care, substance abuse treatment, and prescription drugs, while overestimating their coverage for long-term care. The public's limited knowledge of health coverage suggests an inability on the part of consumers to evaluate multiple plans on criteria other than cost. A third study by Judith Hibbard et al., in 1998, focused on the elderly population to determine whether Medicare beneficiaries could make informed choices between traditional Medicare and Medicare health maintenance organizations. By administering a 20-question test, researchers attempted to assess beneficiaries' knowledge of the basic differences between HMOs and traditional Medicare. It was assumed that the beneficiaries interviewed, particularly those currently enrolled in Medicare+Choice, needed to possess an adequate knowledge of this difference in order to make a wellinformed healthcare choice. However, researchers found that only 11 percent of subjects had adequate knowledge to choose between the two, and 30 percent knew almost nothing about HMOs. The results of these studies speak rather poorly of the consumer's ability to make informed decisions and promote managed competition. To counteract this trend, many managed care organizations have begun providing consumers with report cards on health plan performance. In addition to assessing care quality, these report cards also tend to contain a great deal of information on the managed care organization, so that informed consumers may make wiser decisions. However, there is strong evidence that most beneficiaries are still unfamiliar with health plan performance measures and their meaning. These studies suggest that most consumers can understand and utilize only a limited number of variables in arriving at their health plan decisions. To date, no study has focused on an unrestricted sample population and how population members' knowledge of managed care correlates with the variables they considered when choosing a health plan. Armed with this knowledge, health plan administrators and government officials may gauge the consumer's responsibility in health care choices, while learning to provide requisite information for consumers to make educated decisions. Methodology Data collection for this study began with the construction of a survey divided into three sections. The first section asked respondents for some general information, including age, sex, level of education, and income. These characteristics are commonly Â

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used demographic variables indicating the diversity of a study population. One hypothesis at this study's onset was that a respondent's age, level of education, and income would be positively correlated with his/her knowledge of the health care system. The second section of the survey requested information on the respondent's experience with health care. It included 7 questions, 6 of which asked respondents to characterize their current health and insurance status. These questions were included to obtain an accurate picture of how extensive their familiarity with the healthcare system was while focusing on managed care. Once again, it was predicted that those who had health insurance, favorable experience with managed care, or had been to the doctor more frequently during the past year would score significantly better on the quiz. The seventh question asked respondents to rank the importance of the following eight measures in choosing their health plan: price, quality indicators, choice of provider, benefit/coverage breadth, convenience, reputation, recommendation by a friend or family member, and recommendation by a physician. The third part of the survey was intended to test the respondents' knowledge of managed care. Because almost no existing instruments assess knowledge about managed care, instrument development was a major focus of the research effort, and earlier research was often drawn upon in the subject matter. The ten items on the quiz were carefully designed to adequately reflect the knowledge needed for consumers to make informed choices. The first 4 questions asked respondents to match the type of managed care plan with its best description and included four types of plans: Health Maintenance Organization, Preferred Provider Organization, Point of Service, and Independent Practice Organization. This list was based on the belief that if consumers are to make informed choices between these varying forms of managed care, they need to understand the basic concept behind each. Questions 5 through 7 provided respondents with a health plan description and asked whether it most closely characterized traditional indemnity insurance, managed health care, both, or neither. The items focused on plan mechanisms involved with primary care providers, physician payment, and emergency care. Questions 8 through 10 presented respondents with a given preference and asked whether the type of consumer described should enroll in traditional indemnity insurance, managed care, or if these plans are about the same. The questions focused on the implications of choice relating to treatment, preventive care, and physician autonomy. Educated consumers should be able to understand the basic distinguishing characteristics between indemnity insurance and managed care, as presented in the last 6 questions, if they are to make informed decisions. Respondents were encouraged to mark "I don't know" if they didn't know the answer to a question, but were given credit only for a correct answer. In interpreting the results, scores of 8 to 10 reflect "adequacy to mastery"; scores of 6 to 7 reflect "poor to near-adequate knowledge"; and scores of 5 or lower reflect "inadequate knowledge" of the healthcare system. The survey's design tested an initial hypothesis that respondents with higher scores on the quiz would rank quality indicators, choice of provider, and benefits/coverage breadth significantly higher on the survey than those who scored lower on the quiz, thus demonstrating their ability to evaluate plans more effectively on intrinsic qualities other than price. The survey was distributed to a population of individuals at least 18 years of Â

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age at Los Angeles International Airport. This site was chosen because it would be possible to get a geographically diverse sample assuming that many of the individuals chosen to participate were flying home after the holidays. It eliminated the need to survey consumers in different geographic regions in the interest of obtaining a nationally representative sample. An unbiased sample population was forged with the random selection of subjects according to row seating. Unfortunately, some bias may have been introduced to the study in light of the fact that certain characteristics (i.e. higher income) may make an individual more likely to use airline travel. Of the individuals approached with the survey, approximately 70 percent agreed to participate in the study. Those that refused to participate did not predominantly belong to any particular sex, age group, or race. Of the 100 surveys distributed, 8 were returned without any answers to the managed care questions, and were therefore removed from the sample. Though a larger sampling size would lend more reliability to research results, 92 surveys nevertheless provide enough information from which to draw conclusions in this small-scale study. Results Scores on the 10-item quiz on managed care were remarkably low. Respondents got an average of 4 answers correct, a score well below adequacy. Based on the criteria established earlier in the study, only 7 percent of subjects demonstrated adequate knowledge (scores of 8 or higher) to make an informed choice in the managed care marketplace. Approximately 78 percent scored in the "inadequate" range (scores of 5 or lower) and 28 percent scored in the lowest quartile (equal to or worse than guessing). Although respondents were encouraged to mark "I don't know," random guessing may still comprise a large majority of the wrong answers. Scores on the first four questions, in which respondents were asked to match the type of managed care plan with its description, were much lower than those of the last six questions, in which respondents were asked to distinguish the differences between indemnity insurance and managed care. Respondents scored an average of 29 percent on the questions in the first section, 52 percent on the second section, and 43 percent on the third section. However, several respondents also claimed that the descriptions of different managed care entities were very similar whereas the differences between indemnity insurance and managed care are actually more distinct. As hypothesized, age, level of education, and income were found to be statistically significant variables. Older males with higher levels of education and higher incomes had higher knowledge scores. Furthermore, the strongest correlation was found to result from differences in levels of education followed by age, income, and sex. The section asking respondents for their experience with health care was also fairly consistent with current statistics on health care regressed knowledge scores on: (1) Whether the respondent had health insurance; (2) Whether the respondent had experience with managed care; (3) How the respondent characterized his or her experience with managed care; and (4) How many times the respondent had been to the doctor in the past year. In none of the above variables was a statistical significance observed.

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The last question of survey's second part asked respondents to rank eight measures in terms of their importance in choosing a health plan. The median ranking for each criterion was determined, and dummy variables were then assigned to each measure, giving respondents a 1 if they ranked a particular measure higher (more important) than the median and a 0 if they ranked it lower. This divided the population evenly in half and formed the basis from which a comparison of knowledge scores could be drawn. All eight variables were regressed on the knowledge scores. Although there was no statistical significance for any of the variables, it was determined that those respondents who had ranked choice of provider, reputation, benefits/coverage breadth, recommendation by a friend, and convenience higher than the median for each category, scored higher on the knowledge exam. Discussion The results of this study yield some very interesting implications relating to competition in the healthcare market. Survey results suggest that consumers are illequipped to make informed decisions in their choice of health plans, as only 7 percent have adequate knowledge to do so. Based on knowledge exam scores, consumers seem to fully understand that managed care may restrict their choice of provider and/or procedure, but are relatively uninformed of the advantages of managed care over indemnity insurance in terms of over-treatment and preventive care. Choosing between managed care plans would appear almost impossible considering consumer ignorance of the fundamental differences among various types of managed care plans. If effective competition relies on the informed consumer being able to make an educated judgment of the cost/quality tradeoff, it is extremely unlikely that this purchasing strategy can act as an effective market force to reduce health care expenditures and encourage health plans to operate more efficiently. The correlation of scores with individual characteristics also supports the study's original hypothesis, and confirms data previously observed in related studies. Those who were older performed better on the knowledge exam, presumably because they had more contact with the health care system and a greater awareness of its transformation over the past decade. One would expect that consumers who had attained a higher level of education are generally more knowledgeable and more likely to learn about their options before making a decision, and this expectation was confirmed by their higher exam scores. Consumers with higher incomes also fared significantly better on the exam, possibly because higher economic status provides more choices in the healthcare market and allows information rather than cost restraints to sway consumer. Contrasting the relationship between general characteristics and knowledge scores, none of the measures related to health care produced a statistical significance when regressed. As one would expect, those who were currently insured had more experience with the healthcare market and demonstrated that they knew more about it firsthand by scoring higher on the exam. The same is true of those who had experience with managed care and consequently scored higher on the managed care exam. However, the fact that neither difference was statistically significant suggests that these populations have not learned a tremendous amount more from either their experiences with their health plans, Â

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or from the information provided by their plans. Consumers may view this information as relevant at the time of plan choice but forget its details thereafter. The respondents who had visited the doctor more often during the past year scored higher on the knowledge exam as their utilization of medical care services increased. It was expected that greater usage of medical services would most likely lead to increased familiarity with one's health plan and a more complete knowledge of the plan's features. However, no statistical significance was observed within this trend. In what was perhaps the most surprising result, respondents who were more satisfied with their experience with managed care received lower scores on the knowledge exam than those who were relatively unsatisfied. This contradicts previous literature that states that if consumers lack an understanding of how managed care works, the likelihood of consumer dissatisfaction is greater. Most likely, this result was due to the fact that those who are more knowledgeable about managed care may have higher standards and expectations for the performance of their health plans whereas the relatively ignorant consumers have no standard for comparison. Such results would encourage policy makers to focus on efforts to educate consumers not only to allow them to make educated decisions but also so that they demand a higher quality of care from their health plans and are not so easily satisfied. Since no statistical significance was observed, this trend is one that should be explored in the future in similar surveys with a larger sampling size. On the final survey question which asked respondents to rank the importance of 8 measures in choosing a health plan, the results that were found have serious implications for some of our most established beliefs about decision-making in health care. First and foremost, one must notice that respondents ranked price as only the third most important criterion in choosing a health plan. This strongly contrasts all previous literature on the subject in which cost has been found to be the most common feature of importance to consumers in several studies examining decisions about health insurance choice. If accurate, this finding speaks very well toward the ability of competition to work in the health care market and is further supported by the fact that consumers ranked benefits/coverage breadth and choice of provider first and second, indicating than they do evaluate plans on qualities more than just price. Nevertheless, its credibility is undermined by the contrasting studies which unquestionably place price at the top of the decision-making ladder and furthermore because the results of the knowledge exam would indicate that consumers can't possibly evaluate plans on their other qualities with their current level of knowledge about managed care. Perhaps this phenomenon is best explained by the heightened level of morality found when people fill out a survey and often answer what they think they should do rather than what they actually do. Another surprising result was the fact that quality indicators ranked fifth on respondents' list of decision-making criterion which would suggest that they are generally unhelpful. Although the availability of informational materials to aid consumer health care purchasing decisions is increasing, very little has been done to learn about how useful and valuable they are to consumers. These results would suggest that a great deal must be done to make this information more understandable and helpful. It also supports the notion of taking a slightly different approach in educating consumers about their choices and trying to teach them about managed care outside of the decision-making context Â

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instead. Regressing those eight measures on knowledge scores also yielded some interesting results. Those with a lack of knowledge about managed care were more likely to rely heavily on price in coming to their decision whereas a greater understanding made one much more inclined to consider choice of provider and benefits/coverage breadth. In fact, when choice and benefits were combined into one variable, the result was a statistically significant positive correlation between knowledge and ranking, which affirms the major hypothesis stated at the onset of this study. Apparently, those who are sufficiently educated will be more inclined to take into consideration these factors in arriving at what researchers call an "informed decision." Keeping this in mind, knowledge of managed care is a critical component of competition if consumers are to make managed care choices based on intrinsic qualities other than price. Surprisingly, those receiving higher scores on the knowledge exam tended not to utilize quality indicators when arriving at their health plan decision. This may be due to the fact that more knowledgeable consumers are often increasingly critical and skeptical of not only health plans but also with regards to report cards and health plan ratings. They will need to be convinced that the organization that gives them this kind of information does not represent any particular special interest group and can be trusted while those who understand managed care less fully will be more inclined to trust them and take them at face value. As consumers learn more about managed care, this issue will have to be explored more fully and perhaps several different measures will emerge to provide more support and credibility. Conclusions Current strategies to reform health care rely on encouraging consumers to make informed choices in order to help discipline the market. However, it would appear that due to their lack of knowledge, most consumers are unable to do so. Though respondents claimed that price played less of a role in their decision to enroll in a health plan than choice and benefits, one should very seriously question this statement. It's clear that a greater understanding of managed care makes one more inclined to consider plan design and coverage when choosing a health plan while a lesser understanding makes resort to price when making this crucial decision. On the basis of the extremely low scores on the knowledge exam which revealed an "inadequate" knowledge of managed care, it doesn't seem possible that consumers can equally evaluate plans on qualities other than price. What seems more likely is that consumers make the cost decision first and then compare the quality of offerings within the cost strata. This, however, may create incentives for plans to reduce quality in order to simply decrease prices and attract as many enrollees as possible. In opposition to the principles of competition, this situation can be characterized as a market failure. To remedy this problem, we may look towards increased involvement on the part of government and employers. To date, very little consumer education has been available to help enrollees understand differences among their options. If a pro-competitive strategy is to be employed in the managed care marketplace, special efforts are needed to educate and inform the general population about their managed care options. This task must go beyond the sort of information dissemination found in brochures, pamphlets, and report Â

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cards to an active education program that reaches out not only to managed care enrollees but everyone. The government should take a strong role in this educative process by distributing general information on managed care and providing toll-free phone numbers that people can call with questions on health care delivery. Employers must give their employees some degree of choice and should provide intermediaries who can teach them about health care and explain their options. Together, they can promote competition in the healthcare market by teaching the consumer about delivery system options and allowing them to apply this knowledge to make an informed decision. Michael Housman is an undergraduate at Harvard University.

References 1. Newhouse J, et al. "How Sophisticated Are Consumers About the Medical Care Delivery System?" Medical Care, March 1981, 19(3): 316-328. 2. Garnick D, et al. "How Well Do Americans Understand Their Health Coverage?" Health Affairs, Fall 1993, 12(3): 204-212. Engelmann S, Carnine D. Theory of Instruction: Principles and Applications. New York: Irvington, 1982. Enthoven A. "The History and Principles of Managed Competition."Health Affairs Supplement, 1993, 10: 24-48. Gaus C. Consumer Survey Information in a Reforming Health Care System. Rockville, Maryland: Health Systems Research, Inc., 1994. Hanes P. Grading Health Care: The Science and Art of Developing Consumer Scorecards. San Francisco: Jossey-Bass Publishers, 1998. Hibbard J, et al. "Can Medicare Beneficiaries Make Informed Choices?" Health Affairs, November/December 1998, 17(6): 181-193. Hibbard J, et al. "Informing Consumer Decisions in Health Care: Implications from Decision-Making Research." Millbank Quarterly, 1997, 75(3): 395-414. Martino JM. Returning to Consumer-Based Healthcare. New York: The Conference Board, 1998. McCormack L, et al. "Consumer Information Development and Use." Health Care Financing Review, Fall 1996, 18(1): 15-30. Miselli M. "What Information for the Patient? Large Scale Pilot Study on Experimental Package Inserts Giving Information on Prescribed and Over the Counter Drugs." BMJ, December 1, 1990, 301(6763): 1261-1265.

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Mushkin S. Consumer Incentives for Health Care. New York: Neale Watson Academic Publications, Inc., 1974. Scanlon D, et al. "Consumer Health Plan Choice: Current Knowledge and Future Directions." Annual Review of Public Health. 1997, 18: 507-528. Somers A. Promoting Health: Consumer Education and National Policy. Germantown, Maryland: Aspen Systems Corporation, 1976

Health Highlights Bioethics: Then and Now Allan M. Brandt, PhD From the viewpoint of a medical historian looking back at the last quarter of the twentieth century, the rise of bioethics as a movement and a discipline is nothing short of remarkable. During this period, an intensive medical and public discourse emerged that identified and debated critical moral dilemmas in medical care and research. The signs of this bioethics "revolution" are all around us. Hardly a day goes by when some moral conundrum of medicine is not aired on the front page, or, even more significantly, on television or the Internet. In our clinical institutions, the impact of bioethics is readily apparent: IRBs (Institutional Review Boards) actively assess the ethics of virtually all proposed human subjects research; the Joint Commission on Accreditation of Healthcare Organizations has mandated that hospitals have a mechanism for resolving ethical dilemmas. In most American medical schools, the teaching of medical ethics has become an important component. National Board exams test candidates for their understanding of key ethical principles. And now, interactive sites on the Internet provide immediate instruction and counsel for vexing ethical dilemmas.[1] This impressive set of activities marks an opportune moment to briefly assess the historical origins of bioethics, as well as its effectiveness in addressing contemporary moral problems in American medicine. As recently as 1970, the world of medicine was sacrosanct; its considerable cultural and political authority made it almost unthinkable that so much could become open to public debate, and that patients might reclaim authority over medical decisions and practice. In this respect, many observers of the rise of bioethics have declared it a dramatic victory in the name of moral progress.[2] Bioethics offered a sharp critique of the insular world of medical research and the paternalistic tradition in medical practice. Among the most powerful triggers for the emergence of bioethics were a series of public revelations of gross abuses of human subjects who had been unknowingly coerced into participation in dangerous, nontherapeutic research. The Tuskegee Syphilis Study, the Willowbrook Hepatitis Study, and a long list of studies identified in anesthesiologist Henry Beecher's heroic 1966 analysis in the New England Journal of Medicine[3] are but the most prominent examples of tragic failures within research medicine to respect basic human rights. Together these revelations - and others like them - exposed a research culture in which the interests of subjects had been fundamentally disregarded in the name of science.[4] Rising concern about research ethics also pointed to more fundamental questions about the character of medical authority within clinical medicine. Informed consent soon became the most basic premise for both research and clinical care.[5] The rise of bioethics can only be fully understood in the broader context of the rights-based movements for self-determination in the 1950s and 1960s; these include the civil rights movement, the rise of a new women's rights movement, and the early patient rights activities focused principally on psychiatric issues of civil commitment and the right to refuse treatment.[6,7,8] There can Â

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be little doubt that the rise of bioethics had a substantial impact in reorienting certain aspects of research and therapeutic practice. It led to a new patient-centered ethic, often advocating patients as genuine participants in their care rather than only the objects of diagnosis and treatment. Assessing the deeper impact of bioethics in medical and research practice is, however, no easy task. A much-needed fuller assessment would require considerable historical and sociological investigation of a range of variables that are under any circumstances quite difficult to measure. Do patients today really exercise more autonomy over medical decision-making? Are research subjects better protected from the intensive and competitive demands of new scientific knowledge? Just as we might assess equity in access to medical care, we might ask if all patients have had equal access to the advantages of new ethical precepts. Is there a socio-economic gradient? Do bettereducated patients, for example, benefit more significantly from informed consent than less well-educated ones? No doubt, much has changed over recent decades, but there are still significant problems. And indeed, some critics have actually argued that bioethics, regardless of its progressive intent, has actually had the effect of enhancing medical power over patients and research subjects by legitimating medical institutions and practices. To cite but one obvious example, the consent form - in both research and therapeutic contexts - is often viewed by subjects and patients as but a legal apparatus to protect researchers and physicians from liability. In short, the development of bioethics was historically contingent; it reflected - and responded to - a series of specific contemporary critiques of biomedical practice and was fundamentally shaped by the social and political conventions of the time in which it emerged. Therefore, the bioethics that emerged in this period may no longer be a particularly good "fit" for the range of moral and ethical dilemmas currently confronting American medicine. Informed consent, the hallmark of bioethics, takes physicians' authority as a given. The prevailing assumption was that if physicians adequately respected patients' autonomy, their considerable authority would pass (through knowledge) back to their patients. Patient autonomy, therefore, rested upon an a priori physician autonomy. Bioethics in this form rarely considered the broader social and institutional contexts in which this ethical transaction occurred. But today we see the authority and autonomy of the provider under attack. Importantly, if patient autonomy was at the center of discussion over the past decades, today physician autonomy seems to be the critical issue. A brief and perhaps typical clinical vignette illustrates aspects of this problem: A patient with moderate back pain of relatively short duration comes to see her primary care physician. After taking a history and carefully examining the patient, the physician recommends ibuprofen and rest. He explains that if there is no improvement in the next week the patient should let him know so that they can follow-up. As the patient is leaving, she asks if she might need an MRI. He explains that it currently isn't indicated, but that if she doesn't improve - as he expects she will - they can pursue other diagnostic options, perhaps including an MRI. The patient then asks if he is not ordering the MRI Â

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now because of financial incentives. The doctor is troubled by this exchange and what it represents about his relationship with his patient. This vignette indicates that forces external to the doctor-patient interaction have altered the character of the relationship. Even though the doctor may believe that he would never compromise a patient's appropriate care regardless of financial incentives, his patient is concerned. The quality of trust has been altered, perhaps permanently. The patient worries that the doctor has lost his authority to care, and that his autonomous capacity to act in the patient's interest is eroded by new and often hidden rules and financial incentives. Such issues are, of course, not new to managed care. Physicians have always operated under the influence of considerable external (sometimes hidden) incentives. The point here is that bioethics - as it came to be constituted in the 1970's and 1980's - offered little in the way of analyzing such forces, be they economic, cultural, or psychological. Nonetheless, managed care has challenged the authority upon which bioethics was constituted. As bioethics evolved over recent decades, the central question for healthcare providers confronted with an ethical dilemma was typically "what should I do?" Today, many of the dilemmas of medical care focus instead on the question: "what can I do?" This question recognizes essential constraints on clinical and moral choices. This change reflects an important historical shift in assumptions about our health care system and aspects of agency within it and suggests that we may need to rethink medical ethics in critical new ways. Although the parameters of a new bioethics are far from clear, several broad questions are already apparent.[9] We will need more empirical research on practices associated with ethics both in patient-provider relationships and in our healthcare institutions and systems. Medical ethics is moving beyond the assertion of critical principles to assess concretely the obstacles that may inhibit our ability to realize them. This agenda requires a wide-range of disciplines from clinical caregivers to the humanities and social sciences, as well as stronger assessment of the relationship of health policy to medical ethics. Only a complex dialogue that helps to reveal consensual social and moral values in a diverse culture - a dialogue among experts and the many constituencies doing medical work and seeking medical care - is likely to result in a new and effective medical ethics. In this respect it seems likely that as medicine changes, so too must our medical ethics. This article originally appeared in the Spring, 2000 issue of the Lahey Clinic Medical Ethics Newsletter. Allan M. Brandt, Ph.D., is the Amalie Moses Kass Professor of the History of Medicine at Harvard Medical School and the Director of the Division of Medical Ethics at Harvard Medical School.

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Endnotes 1. National Institutes of Health. Bioethics Resources on the Web www.nih.gov/sigs/bioethics. 2. Rothman DJ. Strangers at the Beside. New York: Basic Books, 1991. 3. Beecher HK. Ethics and clinical research. N Engl J Med 1966;274(24):1354-60. 4. Jonsen AR. The Birth of Bioethics. New York: Oxford University Press, 1998. 5. Faden RR, Beauchamp TL. A History and Theory of Informed Consent. New York: Oxford University Press, 1986. 6. See e.g., Kluger R. Simple Justice: the History of Brown v. Board of Education and Black America's Struggle for Equality. New York: Knopf, 1975. 7. Echols A. Daring to Be Bad: Radical Feminism in America. 1967-1975 Minneapolis: University of Minnesota Press, 1989. 8. Filene PG. In the Arms of Others: a Cultural History of the Right-to-Die in America. Chicago: I.R. Dee, 1998. 9. Kleinman A, Fox, RC, Brandt AM (eds). Bioethics and beyond. Daedalus 1999;128 (4).

Sparks or Smarts: Defending Against Bioterrorism Jonathan L. Burstein, MD The pleasant New England spring is darkened by the shadow of illness. As May turns to June, and on into the summer and fall, a growing number of Bostonians are struck down by smallpox. Nearly 1 in 5 of the infected dies, and by the time the epidemic is over, about 1500 people will have become "cases". The Board of Health is forced to establish emergency quarantines and hospitals. The police enforce mandatory vaccination laws with truncheons and guns. They are especially vigorous in pursuing the homeless. Opponents of these laws charge that the board has "forcibly assaulted persons to vaccinate them."[1,2] Little expensive medical technology is available for either diagnostic or therapeutic purposes. Nevertheless, the efforts of the city's medical system and public health offices manage to containing the epidemic and limiting its effect to 3 of 1000 citizens. Following the recent mail-borne anthrax attacks, we have witnessed increased advocacy by both academic and commercial entrepreneurs for massive spending on research and deployment of the latest biotechnology and information systems to ward off a bioterrorist threat. Claims have been made that new detectors will detect approaching anthrax clouds from miles away, and that new automated surveillance systems will alert the nation about outbreaks without ever needing to involve a human decision-maker.[3] Many argue that the absolute priority for new research and funding should be devices, whether electronic or biochemical. Yet, the fact is that public health responses already utilize a strong base of effective medical and informatics technology to identify and treat infectious disease. The work of researchers in harnessing this technology has made the greatest contribution to our ability to understand and address public health risks. Keep in mind that humans and microbes have been locked in struggle for millennia, and we are quite able to rapidly identify infectious organisms with existing techniques. Treatment of the agents of potential bioterrorism is reasonably well understood at present, largely because of the general knowledge of infectious diseases we have developed through statistical analysis, medical and biological research, and outbreak control. Despite our best public health initiatives, it is sobering to think about the actual public health threats we continue to face. Every year, over 5,000 Americans die from foodborne illness, and about 325,000 require hospitalization for the same cause.[4] Facing this enemy, on our behalf, is our overburdened public health system. Dr. Leslie Beitisch of the Oklahoma state health department notes that "we have seen declining support and investment in public health for four or five decades."[5] In fact, some public health departments still use pencil and paper to keep records (3). In this context it seems easy to argue that the money flooding into bioterror defense should be spent on technology, but a closer look at the actual response to recent anthrax attacks points out some very different lessons. The major weaknesses in the country's Â

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response to the recent attacks were problems with communications, collaboration, and mass testing and treatment.[6] None of these issues can be solved solely by the application of technology. Instead, they require training of personnel, study of how people react to explanations of threats, and practice in the use of plans. The "paper plan syndrome" is a common problem in disaster response, and no more so than here. Without training, drills, and practice, a disaster plan is simply a document of questionable value.[7] It is especially interesting that a task force formed by the U.S. Public Health Service's Office of Emergency Preparedness had named these very issues as those most critical to disaster response in their report of April 23, 2001.[8] But where was the lapse? Funding, whether from government or private sources, usually is directed towards particular tools rather than the towards people who must use the tools. Money should be directed to expanding the staff of public health agencies, training medical professionals in the general infectious disease threats we face, and developing methods for better teaching and better communication with the public. Agencies must not focus on the latest whiz-bang detector, or on yet another regurgitation of outdated and poorly written texts listing bioterror agents. They must encourage better training methods, support the development of validated, accurate, and useful educational materials, and support improved response efforts. Medical professionals of all kinds cannot train and practice for an actual bioterrorist attack unless someone pays for their time and the salaries of those who cover for them during their absence for training. Money should go to training, not to contractors and companies who repackage and edit free government documents and sell them back to public agencies while posing as experts, or who offer authoritative training to hospitals and medical professionals when they themselves are poorly versed in the subjects they teach. Of course, this is not to say that money should never be spent on new technology. Clearly, such expenditures have brought us to our current level of medical sophistication. The focus of such research, however, should be more general. Instead of an anthrax detector chip, how about an automated, reliable, and cheap system to process blood cultures for all common infecting organisms? How about encouraging the use of consistent electronic medical record format, which could allow many public health surveillance and research projects to be conducted? Focusing our efforts proactively on public health resources generally rather than reactively on specific diseases or "quick-fix" technologies would allow us to spread public health benefits across a wider range of maladies and a broader group of vulnerable or affected populations. Historically, technologically unsophisticated public health works have made the most significant impacts on the prevention and detection of outbreaks. The smallpox outbreak actually occurred in Boston in 1901, and was stopped through "shoe-leather" epidemiology (steady and comprehensive data collection and analysis) and good routine medical practice.[1] Another smallpox outbreak, which struck New York in 1947, was stopped by the same techniques after only 12 cases and 2 deaths.[9] The lesson appears to be that our society should be spending more on training people, rather than focusing on perfecting technology. Without trained physicians and nurses, and without public health Â

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workers to conduct surveillance and interpret the results of the technology, the best tools will remain impotent in the face of a plague. Jonathan Burstein, MD, is a physician in the Department of Emergency Medicine at the Beth Israel Deaconess Medical Center and a research scientist for the Centers for Disease Control and Prevention. He serves on the American College of Emergency Physicians Terrorism Task Force and Veterans' Administration Technical Advisory Group for Emergency Management.

References 1. Albert et al. "The last smallpox epidemic in Boston and the vaccination controversy, 1901-1903." New England Journal of Medicine, 344:375-379 (February 2001). 2. "Vaccination bills in." Boston Evening Transcript. February 20, 1902:3. 3. "Bioterror fears prod warning systems." CNN.com, January 6, 2002. 4. "Beyond bioterror: everyday threats in nearby shadows." Boston Globe, December 30, 2001, D1-D2. 5. "Greater expectations [for public health]." American Medical News, January 7, 2002, 28-29. 6. "Anthrax missteps offer guide to fight next bioterror battle." New York Times, January 6, 2002, A1. 7. Auf der Heide, Erik. "Disaster Response: Principles of Coordination and Planning." http://www.coe-dmha.org/dr/flash.htm 8. "Developing Objectives, Content, and Competencies for the Training of Emergency Medical Technicians, Emergency Physicians, and Emergency Nurses to Care for Casualties Resulting from Nuclear, Biological, or Chemical Incidents." Final Report of the Joint Committee, United States Public Health Service Office of Emergency Preparedness and American College of Emergency Physicians. April 23, 2001. 9. "When smallpox failed." New York Times, December 2, 2001.

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Patient and Physicians: Responses to Publicized Medical Outcomes Gillian Warmflash The New York State Department of Health made evaluations of the quality of heart surgery publicly available for the first time in 1989 when it created a new potential target for public scrutiny of health care. The release of hospital and surgeon-specific data on the quality of care provided to the state's surgery patients who received a coronary artery bypass graft raised many concerns among the medical community. Hospitals and physicians feared that the dissemination of such information could threaten their patient bases and reputations or lead providers to select specific patients to treat to boost their own quality ratings. Hospitals and physicians were also skeptical of the accuracy of the state researchers' analysis of the risk factors involved in the serious surgical procedure known as coronary artery bypass grafting (CABG). Precise adjustment of risk factors is crucial for allowing valid comparisons of quality of care. Over the course of a decade, however, the public - which is more inclined to trust family and friends than statistics - has paid little attention to the reports. Meanwhile, the publication of the reports led hospitals to identify their surgical programs' weaknesses and to improve their patients' health outcomes. The hospitals met the report's original goal of reducing CABG-related death rates and have remained competitive in the health marketplace. The CABG reports reliably assessed heart surgery performance and gave providers detailed rankings of the quality of their care. In response, some institutions have restricted, or even terminated, the surgery privileges of doctors with high risk-adjusted mortality rates.[1] Others have used the data to assign patient to surgeons who excelled in certain aspects of patient risk.[2] The CABG reports also succeeded in identifying programs whose deficiencies in quality of care were systematic, not doctor-specific. Overall, provider adjustments led to significant improvements in quality of care. Just three years after the CABG data was published, the CABG mortality rate dropped by 41 percent. In contrast, the CABG quality of care reports have only had a minimal effect on consumers' choices. Providers worried that patients might overreact to the reports and steer clear of hospitals and doctors with high mortality rates, but their fear has gone unrealized. In fact, high mortality rates did not drive patients to seek treatment elsewhere, nor did low mortality rates result in an influx of new patients.[3] Public availability does not imply public intake. Simply the fact that information is available does not guarantee that it will ever be read. The general population may not have known that CABG quality of care reports were available. Consumers may also have judged cardiac surgery ratings to be irrelevant to their own health care needs. Their healthcare plans could have prevented the possibility of switching to another health care provider. Consumers who read the reports may have had difficulty interpreting them. Medical data and jargon can baffle the average reader. Â

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Consumers tend to act according to habit and familiarity and do not suddenly alter behavior based on new information, even if it is from a reputable source. A person may prefer a particular health care provider because of a history of satisfactory care. Quality ratings for care which fall below average won't necessarily drive patients away. Additionally, the advice of family and friends can outweigh expert opinion.[4] Researchers must track consumer responses to the public release of medical outcomes in order to understand how those outcomes are affecting patient behavior. Currently, data releases like the Department of Health's release on CABG surgery are rather rare, but demands for quality measurement are on the rise. As more state health agencies release quality of care data, and the value and accuracy of such reports are repeatedly confirmed, consumers may increasingly trust such reports and use them as a guide when making their healthcare decisions. Gillian Warmflash is an undergraduate at Harvard College.

Endnotes 1. Chassin, Mark R., Edward L. Hannan, Barbara A. DeBuono. "Benefits and Hazards of Reporting Medical Outcomes Publicly," The New England Journal of Medicine. Vol. 334 (6), 8 February 1996, 396. 2. Ibid, 396. 3. Ibid, 395. 4. Edgman-Levitan, Susan, and Paul Cleary, "What Information do Consumers Want and Need?" Health Affairs. Vol. 15 (4), 1996, 45. References Epstein, Arnold. "The Role of Quality Measurement in a Competitive Market Place," Strategic Choices for Changing a Health Care System (editors U. Reinhardt and S. Altman). Chicago, IL, 1996, pp. 207-34. Health Administration Press.

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International Health Interview with Jeffrey D. Sachs Interview Conducted by Neha Jadeja HHPR: The Commission on Macroeconomics and Health Report for the World Health Organization (WHO) indicates that poorer governments have not yet realized the extent to which underdevelopment in health structure impedes their economic growth, and perhaps more importantly that richer governments have not sufficiently directed their aid towards health sectors. What previous action has been taken to combat this insufficient attention to health, and how do you expect the effects of this report to differ from those of efforts in the past? JDS: It's sad to say there have been many, many calls for increased attention to health over the years, including the very dramatic appeal that was known as Health For All by the Year 2000. This was a major commitment of governments taken in the late 1970s, and of course the world didn't come close to achieving it. So with this report I recognize that it's adding to a list of very nice documents in the past that have made a similar plea. I'm hoping, though, that the lessons of the last quarter-century will mean that this report might have some impact even if other wonderful statements did not achieve what they had hoped previously. What I mean by that is that there has been a period of incredible neglect. Despite the calls for help, the rich countries turn their backs on the poor in the face of the AIDS pandemic and in the face of the economic crises that have hit so much of Africa, parts of Asia, and parts of Latin America in the last 20 years. During that period, the rich countries essentially told the poor countries, "Get your act together, reform your economies, and somehow reform will be its own reward." And while the rich countries did have programs of support for the poor, those programs were completely insufficient compared to the scale of need. So what did we learn in the last 25 years? We learned that reform can't work if diseases are running rampant. We learned that the IMF-World Bank strategy over the past 20 years did not succeed. We learned that the stingy and hands-off approach did not lead to economic recovery but rather led to a downward spiral of impoverishment and even worse health in many, many countries of the world, with hundreds of millions of people caught in this vicious circle. So our report comes after a long period of trying the opposite, essentially, and almost ignoring the problem. And I'm hoping that the lessons of recent history combined with the evidence that we present in this report will make the difference - or make a difference, let's say. HHPR: The recommendations of this report were mainly formed before the September 11th attacks. In view of the current situation and the great push for military build-up, which has garnered both political and public support as never before, how realistic do you find the re-routing of funds from, say, defense spending to international aid spending? Besides good will and humanity, are there other motivating factors, perhaps of Â

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an economic nature, which you and the Commission for Macroeconomics and Health would use to convince U.S. officials to donate to developing countries? JDS: As a matter of fact, September 11 dramatically strengthens the case that we're making rather than weakens it. It's been known in the intelligence community and by foreign policy observers for many years that the problems of impoverishment and ill health contribute directly to security risks in the United States and in other parts of the world. In fact, the CIA issued an important report, its so-called Task Force on State Failure, which found that infant mortality rates are an important predictor of the risk of failed states or collapsed states, which lead to civil war or to violence and often to U.S. military intervention. So the CIA for many years has been aware of the fact that pandemic disease, high death rates, and impoverishment are all contributing factors to the kinds of risks that we face regarding terrorism. But those who hold the purse strings - the Congress and the President - have not responded even to their own intelligence community beforehand. This past summer before September 11th, I published a paper which I entitled, "The Strategic Significance of Global Inequality," and I argued in that paper that we would indeed face risks of increased terrorism and increased instability if we didn't attend to the problems of the very poor countries. People have made the point that Osama bin Laden is not an example of an impoverished individual, so they've argued against the link from poverty to security risk. But they're wrong, actually. The question isn't so much whether Osama bin Laden himself is impoverished or not, but whether the ability to use Afghanistan as a staging base was directly the result of the chaos of that country - a chaos of impoverishment, of course the chaos of a long war, and so forth. So even if individual terrorists are not the direct product of poverty, it is the disarray in the world, whether in Somalia or in Afghanistan or in other impoverished countries, that provides the seedbed or the staging posts for a lot of the risks that we face, and not just in terrorism but in other forms of international criminality - drug trafficking, money laundering, slave trade, and so forth. Now, September 11th obviously makes the immediate budget situation tougher in the United States, and this does pose a challenge on the very specific side of getting the U.S. to put in the funding that is absolutely necessary for our own security and for addressing the global health crisis. But the point we make in this report is that the amounts that we're talking about, even though they sound large - $27 billion from the donor world - amount to no more than 0.1 percent of GNP of the rich countries. That's one penny out of every $10 that we have in the United States each year in our income. This country can afford, before September 11th and after September 11th, spending one penny out of every $10 of income to save, we estimate, eight million lives a year. It's a very clear call in my view. HHPR: Besides convincing the richer countries to fully cooperate with the report's proposal, what will be the biggest obstacle in implementing the solutions and remedying the problems that are outlined in this report? JDS: I think by far, as you've noted, money is the toughest point. And I'm quite frustrated at hearing repeatedly this simple-minded statement that money's not the obstacle; the Â

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obstacle is infrastructure, the obstacle is politics, or the obstacle is corruption and so forth. Well I want to say something very clearly: the obstacle is money. I've just come back from Africa, and I saw a situation in a major hospital, the likes of which I could not have dreamt, even after working on this for so many years. In one ward of this hospital, there was basically a room filled with dying people. It was 70 percent HIV-related inpatients. There were no medicines in the ward, and there were three or four people to a bed. This is something that you can't even imagine: two people in the bed, usually, and then one or two people underneath the bed, literally on the floor, because there's no room in the hospital anymore because it's being flooded with dying AIDS patients. Now the doctors - the few doctors - that were in the ward had nothing to treat the people with, so it was a room full of dying people. Next door was an outpatient service, where the very few people in this country that could afford to buy the AIDS medicines were getting them. And there were a few hundred people on anti-retroviral therapy because they could afford out of their own pocket - a tiny fraction out of those who need it, but still a sizeable number. Those people were responding beautifully to the drugs. The drugs work on Africans just like they work on Americans. They're working very well, very effectively, allowing people to return to their normal lives, allowing people to return to their families, to tending to their children, to staying on the job - to keeping life going in a normal way, to preventing the number of orphans from growing, as they are by the millions in Africa. So here's a case where the delivery of the medicines is absolutely feasible - it's a hospital service; the medicines are working - and yet, nonetheless, thousands and thousands of people are dying in this hospital on a routine basis because they can't afford the medicines. If the money was there, the people would be alive, there would be hope, there would be a chance. So I want to really stress that this mythology that it's not the money, that it's some other factor, is a myth. Of course if the money is there, there will be challenges, but not insurmountable challenges. It's true that in some places in the world, governments are so bad, so corrupt, so authoritarian, that probably not a lot can be done right now. But most of the world, we found in our study, lives in places where the obstacles, however real they are - whether it's not enough clinics, or not enough hospitals, or not enough doctors can be overcome through training, or through building new buildings, or through getting diagnostic equipment in. We found that there are ways to monitor the delivery of this kind of assistance. There are ways to track it, there are ways to audit it, and so forth. Even though money would be wasted, I'm confident that the vast majority of the funds that would flow would go to the people that need it. And when countries fail to deliver the funding to the communities that need it and it fails to reach the people, I think there'll be ways for us to know and to stop the errant funding and to insist that it go to the right place or to cut off communities or countries that can't bring themselves to do it the way it needs to be done. So my point is that we need to scale up - we've looked at a fifteen-year timescale; we didn't say that everything could be done at once. We know that there are lots of new systems that have to be put in place, lots of new managers brought on line, lots of new doctors and nurses that need to be trained, lots of new community health workers that can be brought into this. But none of it is an impossible obstacle. It's a matter of good, Â

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sensible management, funded at a realistic level so that the job can get done. HHPR: What about the case in which a great amount of political instability exists in a developing nation, as is the case in many sub-Saharan African nations? Help can be given to lessen corruption and increase efficiency in a certain regime, but if a new government steps in a year later that needs just as much improvement, what would have been the point? What do you recommend the policy of donor countries be in such a case? JDS: A lot of the political instability in Africa is a result of the impoverishment and disease in the first place, so over the long term, the kind of effort that we're recommending will be an important instrument of reducing that kind of state failure. That is precisely the kind of evidence that the CIA and others have uncovered in recent years, and why we stress that investing in this area actually will lessen that instability. It's also true that some places are so unstable that you can't really envision a scaling-up taking place right now. So what we recommend, and what I, personally, strongly recommend, is that we adequately fund those places that are ready to move. And generally those places that are ready to move - and I'm thinking of places like Botswana, or Tanzania, or Ghana, or Mozambique, or Uganda - have shown a long period of stability, but a long period of impoverishment and difficulty of getting out of the poverty trap. So the idea is that we can direct ample and realistic flows of money to governments that already have some track record and that have been begging us for help, that have even designed programs that show step-by-step how they would do it. And that's where we ought to start, not the very hardest cases. In those cases, certain things can work like immunization campaigns, definitely. But other things which involve very detailed building-up of the health systems probably are too hard in the middle of extreme violence. You have to attend to the violence first and get it under control. But there are lots of surprises when one starts to look stops generalizing in this. I was in Malawi in January. Malawi is one of the most impoverished countries in the world: it's got an average income of just $190 per year, which is just a little bit more than 50 cents per day. This is a remarkably impoverished country. Yet the government has been utterly committed to primary health and to designing a strategy for AIDS control, and they have one of the clearest-thinking strategies that I've seen anywhere in the world. So even in places as impoverished as Malawi, you can find stable government, ready to take the lead and able to design very ingenious and coherent strategies of how to get out of the crisis. But they just don't have the money. HHPR: This question is a bit more personal: As someone who is recognized for his deep compassion and humanitarian instincts, how do you personally deal with creating an "essential services" plan? While it's more economically feasible than a more expensive program, and it's certain to alleviate a lot of the health problems of poorer countries, it still does not provide for a lot of treatments and procedures that are readily available in richer countries. How do you think about this situation in a way that enables you to handle it? JDS: Well it's a very good question, and in fact our report focused very heavily on infectious disease burden: AIDS, malaria, TB, diarrheal disease, respiratory infection, Â

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and maternal health and safe childbirth, and micronutrient deficiency. It did not focus on a lot of chronic diseases where a lot of sick people die also - of cardiovascular disease, cancers, diabetes - very serious conditions that take a lot of lives. I am actually getting started this year on a follow-up study to address those conditions for the noncommunicable disease conditions that we did not focus on because I think that, while it made sense to look at the killer pandemic diseases, one doesn't want to forget this other category. And in fact, there isn't a simple link to say, "Infectious disease, those are the cheap interventions; and non-communicable or chronic disease, those are too expensive." There are going to be plenty of things to do with the chronic disease side that are also absolutely affordable with the realistic levels of help from the donor countries. So one quick answer is: I don't want to stop; I want to try to figure out health as an economist, help the public health community figure out the broader range of interventions. The other part is that I do have a lot of concern of aiming too low in a way: on the one hand, we're asking for $27 billion - is that enough to ask for? I'm not sure, but it's gonna be a heck of a fight to get this far, so I think that this is really worth the fight, and we'll see through further study what other areas ought to be attended to. HHPR: What has been the response of leaders in the third world to this report so far? JDS: So far the response has been extremely exciting, but not yet as broad-based as it needs to be, because information percolates step-by-step. So I've discussed this with the leadership of the government of India, with a very enthusiastic response. They wanted to get moving on a lot of the recommendations, and they want help also internationally to get moving. I've discussed this with the health leadership in China, with a tremendous enthusiasm. So that's already almost 40 percent of the world's population. Last week, I presented the report to the 15 heads of state of the southern African developing community. These are the countries of southern Africa which are bound together in a regional grouping. And they invited me to present the report as the only outside item on a summit meeting that they were holding that focused on strategic issues of war and peace, mainly in the Democratic Republic of the Congo. So this was a wonderful sign for me that the presidents wanted to hear about health in the middle of what was basically a conference on national security. Naturally, I stressed to them that the issues of disease and especially the AIDS pandemic were as much a part of their national security as the rest, and the response was very good. I'm hoping that that presentation to the summit will be followed up by meetings of the technical staffs of these countries to help them get prepared to access funding from the global funding to fight AIDS, tuberculosis, and malaria. And I'm also trying to help them follow up on the recommendation in the report that each country should now have a national commission of macroeconomics and health to get really to the specifics of that country, because our report focused on very broad beams, but each country has to work out its own specific strategies based on its own specific disease epidemiology and its own specific political and geographical and economic conditions. Now, bottom line: very exciting so far, but I expect that I'm going to spend a lot of this year talking to world leaders to help us spread the message even further.

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HHPR: If all goes well and the steps in this report are implemented immediately or in very short order, do you think that the changes in the state of health in these third-world countries will be apparent sooner rather than later? What kind of timeline do you envision? JDS: I think we could see marvelous, exciting, thrilling results within two or three years. It is shocking that even with 65 million people into the AIDS pandemic - 25 million of whom have already died, 40 million people living, infected with HIV - there still is not one single individual in the world that is on an anti-retroviral treatment program supported by official donor funds. So it's a shocking fact of neglect of the rich countries vis-a-vis the poor. Within a very short period of time, we could have hundreds of thousands of people alive as a result of getting onto drugs which will work, which will keep them as fathers and mothers and keep them in their community. We'll see that happening. We could have a spread of anti-malaria programs: increased use of bed-nets, environmental control of the mosquitoes that breed the disease, better case management to save hundreds of thousands of lives within a short period of time. We could help safe childbirth: there are now half-a-billion mothers dying in childbirth, with virtually every one of them in an impoverished country, who with attended-to-skill childbirth would be alive today, or whose deaths could be avoided each year. This could also be introduced very quickly. So I'm very optimistic on the one hand that if we pursue this path, the number of skilled and dedicated people throughout the developing world that will pitch in, that will donate time, that will contribute to this scaling-up of health will be dramatic, and that we'll see the results. Of course, we also stress and spend a lot of time pointing out that this is a long-term effort. Even if certain things can get done quickly, to sustain them and to reach the more distant populations, the poorest people in the rural areas, this is an effort that we really need to invest in for a whole generation to come. And so the early gains will be there, but they should not be a cause for complacency; they should be a reason for inspiration to get on and continue the task for the next 20 years at least. HHPR: Thank you so much for your time and insight. Jeffrey D. Sachs is the Director of the Center for International Development, the Galen L. Stone Professor of International Trade at Harvard University, a Research Associate of the National Bureau of Economic Research, and Chairman of the Commission on Macroeconomics and Health of the World Health Organization, 2000-2001. In January 2002 he was appointed by UN Secretary General Kofi Annan as Special Advisor for the Millennium Development Goals.

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Establishment of the Commission on Microeconomics and Health Derek Willis The World Health Organization's Director-General Dr. Gro Harlem Brundtland established the Commission on Macroeconomics and Health (CMH) on January 18, 2000 to study how health interventions can promote economic growth in developing countries.[1] Professor Jeffrey D. Sachs, a Harvard economist and Director of the Center for International Development at Harvard University, was appointed as chair of the Commission, which presented its final report on December 20, 2001. The Commission also includes 15 economists and policy makers from organizations such as the World Bank, the International Monetary Fund, the United Nations Development Program and the Organization for Economic Cooperation and Development.[2] Dr. Brundtland described the reasons for establishing the CMH and its goals at the launching of the Commission in January 2000, "...few finance officials and development economists have so far explored the potential importance of health investment as an instrument for reducing poverty. The goal of this Commission and its pre-eminent thinkers is to show once and for all that health must be at the heart of development."[3] The Report A global commitment to the poor was made in September 2000 at the Millennium Summit of the United Nations with the creation of the Millennium Development Goals (MDGs). [4] The MDGs created targets for not only reducing poverty but also improving the health of the world's poorest in specific areas by 2015. In regards to health the MDGs focused on the following goals: 1. A two-thirds reduction of 1990 child mortality levels 2. A three-fourths reduction of 1990 maternal mortality ratios 3. An end to the rising prevalence of major diseases, especially HIV/AIDS.[5] Globalization has not only created the possibility of achieving these goals through advancements in technology and the resources of rich countries, but has also made the MDGs a priority for both rich and poor countries. The worldwide spread of AIDS is a perfect illustration of how diseases are no longer confined to the country, or even continent, of their origin. However, diseases in poor countries can exert costs on the rich countries indirectly as well. The Commission cites a study conducted for the United States Central Intelligence Agency in which infant mortality rates were determined to be one of the principal predictors of state collapse (an unconstitutional change in regime) from 1960 to 1994.[6] The subsequent military interventions of the United States into some of these countries were costly both in financial terms and lives lost. Finally, poor management of drug distribution and treatment in a country can lead to drug resistant strains of a disease that can then spread to neighboring countries and render their drugs ineffective as well. Unfortunately however, an increasingly globalized world has not led to a coordinated globalized response to the dangers posed by the dire health conditions in the world's Â

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poorest countries. Both inadequate resources and inappropriate tools for accomplishing their goals have hampered institutions focused on alleviating poverty and improving health. Therefore, one of the main goals of the CMH was to outline not only the amount of financial resources needed and where they should be targeted, but also to highlight how a global partnership can be forged between the rich and poor countries to reach the MDGs of poverty reduction and improved health. The importance of this new approach cannot be overstated: "According to the United Nations Development Program (2001), 62 percent of the population of developing countries are in nations that are 'lagging, far behind, or slipping' in meeting the infant and child mortality goals."[7] Targeted Investments in Health The Commission's studies found overwhelming evidence that targeted investments in health will allow poor countries to make substantial progress in reaching the targets of the MDGs for both poverty reduction and improved health. The Commission identified three channels through which disease impedes economic development. The most obvious is the effect of a lowered healthy life expectancy on the lifetime productivity of people in high disease areas. Lowered life expectancy, measured in the hundreds of billions of US dollars per year, also has a secondary impact on how households determine how much to invest in the health and education of their children.[8] Regions with high infant and child mortality, the Commission notes, are found to have higher rates of fertility due to the households' tendency (being risk-adverse) to compensate for the high probability that some of their children will die. [9] Finally, high disease areas are less attractive for investments by the private sector, especially in the areas of agriculture, manufacturing and tourism.[10] This represents a major constraint to economic growth in Africa where foreign direct investment is extremely depressed. The macroeconomic evidence at a cross-country level also shows a strong relationship between health and economic growth even in the presence of other economic variables. The consensus estimate is that a 10 percent increase in life expectancy at birth is generally associated with a 0.3 to 0.4 percentage point increase in economic growth per year.[11] [Note: We apologize that an image is missing from this article here. We hope to resolve this soon] On the other hand there are those who believe that poor health in low-income countries is due primarily to poor governance and that providing aid to these countries will simply result in misuse of these resources and poor results. A central finding of the Commission from close examination of the epidemiological evidence is that, "the vast majority of the excess disease burden is the result of a relatively small number of identifiable conditions, each with a set of existing health interventions that can dramatically improve health and reduce the deaths associated with these conditions."[12] The primary constraint for the vast majority of countries that prevents them from implementing these known interventions is the lack of financial resources.[13] This identification of specific diseases responsible for a large proportion of the disease burden in poor countries, coupled with a recognition that the lack of resources was the major constraint created the basis for the Commission's report on how to improve the health of the poor as a means of promoting economic development. Â

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The Commission's Report specifically targets low-income countries, with a population of 2.5 billion people. Controlling communicable diseases and improving maternal and child health were identified as the most important areas to be addressed in order to lower mortality rates in these countries.[14] The Report specifically targets the proposed increase in donor aid at the following health conditions:[15] • HIV/AIDS • Malaria • Tuberculosis • Childhood infectious diseases • Measles, tetanus, diphtheria, acute respiratory infection, diarrheal disease • Other vaccine preventable illnesses • Maternal and perinatal conditions • Micronutrient deficiencies (malnutrition) • Tobacco-related illnesses The primary advantage in targeting the above illnesses is that they generally are not technically exacting. Vaccines exist for several of the illnesses targeted and effective interventions are known for the remaining diseases. The reason that these diseases have been so poorly addressed is primarily the lack of financial resources to improve public health institutions and purchase appropriate vaccines and drugs. The Costs of Interventions in Low-Income Countries The Commission closely analyzed the cost of expanding coverage in low-income countries with 1999 GNP per capita below $1,200 (plus the remaining countries in subSaharan Africa with GNP levels above this amount). Their analysis yielded the data presented in Table 1. Their assessment Ð the following steps are needed to achieve minimum expenditure by 2007 - 2015 in least developed countries: (1) an increase in aggregate health expenditures of $57 billion by 2007 and $94 billion by 2015,[19] (2) aggregate budgetary outlays of $35 billion by 2007 and $63 billion by 2015,[20] and (3) to address financing gap, donors will need to provide $27 billion per year by 2007 (in addition to the current aid of $6 billion a year) and $38 billion per year by 2015.[21] The least-developed countries, with an average annual income of $296 and population of 643 million, will receive the majority of this donor money. This is due primarily to the inability of the least-developed countries to generate revenues domestically because of their extreme poverty. The large number of least-developed countries in Africa coupled with the high prevalence of disease there makes this region the recipient of the largest amount of donor assistance.[22] As mentioned earlier, the region that would receive the largest proportion of aid would be Africa. The two diseases that are responsible for the largest share of the public health problem in Africa are HIV/AIDS and malaria. To illustrate the costs imposed by these diseases on the continent the Commission uses the concept of disability adjusted life years (DALYs). DALYs are defined as, "A measure that considers the burden of disease to a population in terms of years of lost life, adjusted for the effect on health to those living with the disease."[23] DALYs can be used to estimate the total economic loss to a

region from a specific disease by multiplying the number of DALYs associated with a disease in a given area by a multiple of average per capita income for that region. Taking this approach, the economic value of lost life years in Africa due to malaria in 1999 is 5.8 percent of the GNP of sub-Saharan Africa.[24] Using the same conservative approach for AIDS in this part of Africa, the Commission found that its 72 million DALYs was equivalent to 11.7 percent of the region's GNP.[25] HIV/AIDS In its Report the Commission specifically highlights the importance of addressing HIV/AIDS, "The HIV/AIDS pandemic is a distinct and unparalleled catastrophe in its human dimension and its implications for economic development. It therefore requires special consideration."[26] In 2000 AIDS was responsible for 3 million deaths worldwide, with 2.4 million of these deaths occurring in sub-Saharan Africa.[27] HIV/AIDS constrains economic growth by primarily affecting people during the prime of their working life. The disease also reduces investment into areas of Africa that would otherwise be favorable due to natural resource deposits and the low cost of labor. In terms of prevention, the Commission recommends targeting adolescents and commercial sex workers because these groups are particularly susceptible to infection and transmission to others.[28] Treatment of HIV/AIDS by focusing on opportunistic infections (OIs) and the use of highly active antiretroviral therapy (HAART) will be costly. The Commission estimated that the total cost of treating AIDS by 2007 will be $14 billion and will be $22 billion by 2015.[29] This amount of donor spending will allow approximately two-thirds of individuals in low-income countries with HIV to receive treatment.[30] However, a portion of these costs will be covered by the new Global Fund to Fight AIDS, Tuberculosis, and Malaria (GFATM), with the Commission recommending the GFATM to fund $8 billion per year by 2007 and $12 billion per year by 2015.[31] Worldwide, the Report predicts that it will be possible to scale up HAART coverage so that by the end of 2006 around 5 million people will be receiving treatment in low-income countries.[32] Malaria The Global Fund will also be a key component in the fight to reduce malaria levels in poor countries. Contrary to the relatively recent outbreak of HIV/AIDS, malaria has represented a sustained threat to public health, especially in Africa, for centuries. Today, in terms of DALYs, malaria is responsible for around 3 percent of the worldwide burden of disease.[33] Recent research has also shown that malaria represents a major impediment to economic growth, with the presence of high levels of malaria associated with a lowering of economic growth of 1 percent per year.[34] The Commission identified several channels through which malaria restricts economic growth, "Diseases such as malaria pose risks to all individuals who may enter a particular location, and therefore depress tourism, block otherwise profitable investments, or prevent the effective economic use of arable land or other natural resources."[35] One of the major problems with malaria control programs of the last two decades has been the lack of reliable, sustained funding for a long period of time. The need for donors to see immediate results in order to deem their spending as being "cost-effective" has naturally biased their selection of malaria control interventions away from methods that require longer time Â

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periods to see results. This has led to the exclusion of traditional methods of controlling malaria, such as environmental management for mosquito control, that have proved to be successful in the past. Although it has a successful track record in the long term, environmental management typically requires at least three to five years to see significant results.[36] The Commission recognized the importance of sustainability of funding for malaria, as well as other diseases, and noted that, "...donor assistance will be required for a sustained period of time, perhaps 20 years, but will eventually phase out as countries achieve higher per capita incomes and are thereby increasingly able to cover essential health services out of their own resources."[37] The Report outlines a plan for scaling up malaria prevention activities from an estimated current coverage of 2% (2002) to 50% by 2007 and 70% by 2015.[38] Malaria treatment coverage would be increased from a present coverage of 31%, to levels of 60% and 70% by 2007 and 2015 respectively. The Commission estimates that for 2007 and 2015 the cost of malaria prevention programs will be $2 billion and $3 billion, while the cost of malaria treatment programs will be $500 million and $1 billion. Addressing Local Conditions One important distinction that the Report makes is that in order to develop a coherent and effective public health strategy to deal with diseases such as HIV/AIDS, malaria, and the other targeted diseases it is important to understand local conditions beyond the traditional health sector itself.[39] Local conditions could generally be described as the ecological, social, and demographic characteristics of an area. The Commission specifically notes three characteristics that are critical to creating an effective health policy for a country:[40] 4. Underlying health infrastructure and technology (clean water, urban sew age, trash collection services, and advances in agricultural technology) 5. Ecological conditions (effect of temperature, rainfall, specific disease vectors, and clean water availability on disease prevalence) 6. Social conditions (literacy rates, women's social status, sexual practices) Addressing these underlying and unique traits is necessary in order for low-income countries to develop appropriate strategies for addressing the key diseases relevant for their given setting. Recognizing the importance of not imposing a universal blueprint to improving public health on all low-income countries the Commission recommends the creation of a National Commission on Macroeconomics and Health (NCMH) by each country. Each NCMH would have two years to assess which diseases should receive the highest priority and how extending coverage to address these diseases should be coordinated with existing health services while remaining consistent with the country's macroeconomic policies.[41] The NCMH would be chaired by the country's Ministers of Health and Ministers of Finance and would also include key representatives of civil society involved in the provision of health services.[42] At a sub-national level the Report identifies the scaling up of the delivery of health services to communities as the highest priority.[43] The Commission outlines a plan for strengthening the staffing and infrastructure for providing health services at the community level by creating a system referred to as the close-to-client (CTC) delivery Â

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system.[44] The CTC system would be made up of a range of health facilities, including basic hospitals, health centers, and health posts. The non-technical nature of many of the essential interventions the Commission focuses on do not require hospitals or doctors.[45] Health centers will therefore represent a key point of delivery for the essential interventions with nurses and trained paramedical staff being the principal providers.[46] The Commission recommends that the creation of a CTC system in a lowincome country complement, rather than replace, existing national programs focused on diseases such HIV/AIDS, malaria, and TB because of the expertise that has been developed using this categorical approach.[47] Financing Strategies The challenge to donors to significantly increase international financing in the form of grants and to recipient countries to use these new resources efficiently to scale up interventions using the CTC system is daunting. Overcoming this challenge is essential to meeting the MDGs of 2015 but will require a new type of partnership between the rich and poor countries as the provision of assistance will be in the form of grants, rather than the traditional approach of nonconcessional loans. While the Commission recommends that the World Bank extend long-term, nonconcessional loans to middle-income countries in order to ensure universal access to essential interventions, it recognizes that this approach is not feasible for low-income countries. The Report, therefore, recommends that a useful framework for shaping this new partnership between donors and low-income countries is the emerging Poverty Reduction Strategy Paper (PRSP) process, along with the Heavily Indebted Poor Countries Initiative (HIPC).[48] The Commission defines the PRSPs as providing, "...the basis for assistance from the World Bank and the International Monetary Fund as well as debt relief under the HIPC initiative. PRSPs should be country-driven, comprehensive in scope, partnership-oriented, and participatory."[49] The PRSP process is particularly relevant for a partnership designed around investing in health to promote economic development because it is a multi-sectoral process focusing on a broad array of social investments in areas such as health, education, sanitation, and gender relations.[50] The Commission has identified all of these areas as being relevant to developing a comprehensive approach to improving health in lowincome countries. The successful submission of PRSPs is tied closely to the debt relief provided to heavily indebted poor countries under the HIPC Initiative. The Initiative will, "...reduce debt servicing by around 2 percent of GNP for some 30 heavily indebted poor countries, and perhaps around one-fourth of that will be allocated directly to the health sector."[51] The PRSPs, combined with the HIPC Initiative, therefore represent a promising way in which to develop a new partnership between donor agencies and recipient countries while also increasing the capacity of low income countries to raise more revenues internally for health. Implications for the future Jeffrey D. Sachs, the Commission's Chairman, described his vision for the Report in an email to his colleagues, "I can be 'realistic' and 'cynical' with the best of them-giving all Â

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the reasons why things are too hard to change. We must dream a bit, not beyond the feasible but to the limits of the feasible, so that we inspire."[52] The challenges facing the implementation of the plan described in the Report of the Commission on Macroeconomics and Health are many. Generating the political will in rich countries to drastically scale up their commitment to helping the world's poorest will be difficult in this time of increasing donor fatigue. Developing new sustainable partnerships between donor and recipient countries might prove to be even more challenging. The potential benefits, however, are enormous. The Commission estimates that implementation of the outlined essential health interventions could save approximately 8 million lives per year by 2010.[53] This improved health will occur primarily in the least developed countries and will promote economic growth and poverty alleviation in a number of ways. Successful implementation of the Commission's plan will also aid greatly in achieving the Millennium Development Goals for 2015. More importantly, the generation of a sustained commitment by the rich countries to the health of the world's poorest will prove that globalization can indeed create a more united, healthy, and economically prosperous world. Derek Willis is a graduate student of economics at Harvard's Kennedy School of Government in the Master in Public Administration in International Development program.

Endnotes 1. World Health Organization. 2000. Press Release: "WHO, Internationally-Renowned Economists Launch Commission on Macroeconomics and Health." http://www.who.int/inf-pr-2000/en/pr2000-02.html (cited 18 January 2000). 2. Ibid. 3. Ibid. 4. World Health Organization. 2001. Report of the Commission on Macroeconomics and Health. Macroeconomics and Health: Investing in Health for Economic Development. Geneva: World Health Organization, 1. 5. Ibid, 28. 6. Ibid, 28. 7. Ibid, 29. 8. Ibid, 30. 9. Ibid, 30. 10. Ibid, 30. 11. Ibid, 1.

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12. Ibid, 4. 13. Ibid, 4. 14. Ibid, 2. 15. Ibid, 16 and 42. 16. Ibid, 16. 17. Ibid, 16. 18. Ibid, 16. 19. Ibid, 11. 20. Ibid, 18. 21. Ibid, 11. 22. Ibid, 11. 23. Ibid, 187. 24. Ibid, 31. 25. Ibid, 31-32. 26. Ibid, 16. 27. Ibid, 47. 28. Ibid, 49-50. 29. Ibid, 53. 30. Ibid, 53. 31. Ibid, 53. 32. Ibid, 51. 33. Ibid, 79. 34. Ibid, 25. 35. Ibid, 38.

36. Utzinger, Juerg, Tozan, Yesim, and Singer, Burton. 2001. "Efficacy and costeffectiveness of environmental management for malaria control." Tropical Medicine and International Health. 6(9): 1-11. 37. World Health Organization. 2001. Report of the Commission on Macroeconomics and Health. Macroeconomics and Health: Investing in Health for Economic Development. Geneva: World Health Organization, 12. 38. Ibid, 54. 39. Ibid, 73. 40. Ibid, 74-75. 41. Ibid, 10. 42. Ibid, 10. 43. Ibid, 64. 44. Ibid, 64. 45. Ibid, 7. 46. Ibid, 65. 47. Ibid, 68-69. 48. Ibid, 27. 49. Ibid, 196. 50. Ibid, 27. 51. Ibid, 61. 52. Ibid, cover page. 53. Ibid, 11.

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The Paradoxical Transition in Chinaâ€™s Health System Yangzhong Huang, PhD During the early 1980s, Chinese health policy was marked by an emphasis on marketdriven reforms, undermining the collective-based healthcare system set in place during the Mao era (1949-1976). Health policy under Mao was such a salient and contentious issue that Mao and the party center became directly involved in the policy process, minimizing the role of state bureaucrats in the Ministry of Health. In his infamous "June 26 Directive," Mao vehemently criticized the Ministry for paying attention only to "urban lords" and called for "putting the emphasis on the countryside." As a result, formal medical education was discouraged and a large number of urban medical personnel wassent to rural areas. Given the shortages of health resources, preventative care became a key feature of China's health system. Thus by the 1970s, China was able to provide affordable primary care by establishing a well-articulated rural health system. However, the success of this arrangement relied on the endurance of a collective agriculture in the countryside, the cornerstone of Maoist socio-economic structure. When policymakers liberalized agriculture in the early 1980s, communal welfare funds (the main source of rural health financing) were eliminated. Post-Mao fiscal decentralization, which required each level of subnational government to be responsible for its own health care services, further eroded the local health resource base. Thus each administrative unit at the lower level controlled fewer health resources. Under such financial constraints, the proportion of villages offering Cooperative Medical Care, a community-based health insurance scheme, dropped rapidly from 90 percent in 1979 to just 11 percent in 1983.[1] Meanwhile, the number of "barefoot doctors," practitioners with an informal medical education, fell by one-fifth, reducing the number of available medical personnel in the countryside.[2] China's market-oriented reforms, widely credited for fueling its economic growth, thus put a universally acclaimed and well-documented health care system in disarray. Creating a market-based health sector was a priority for China's central leadership, who viewed delivering high rates of eco-nomic growth as essential for its political legitimacy, and thus retreated from government involvement in health care. Leaving the health system to market dynamics, however, not only worsened the public health but also sparked dissatisfaction among China's masses, who still believed in a strong state role in health care and other social programs. Resolving this social tension will be crucial for the Chinese state to firmly establish its legitimacy, just as protecting the public health will be required for sustainable development. Market-Oriented Healthcare Reform Broad changes in the post-Mao political economy encouraged health bureaucrats to aggressively disassemble the rural-oriented health policies that Mao had fostered. Reflecting the party center's attempt to move contentious issues from the political arena to the more "neutral" zone of administration, the Ministry of Health regained its control of healthcare policymaking in the early 1980s. Free from the constant involvement of top Â

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party leaders, health bureaucrats who were purged by Mao after 1965 reasserted themselves, criticizing or even abandoning Maoist health policy. A national agenda shift held these bureaucrats under sway, as the slogan "politics takes command" gave way to "economic construction prevails." Applying this emphasis on economic development and modernization, the Ministry directed its provincial branches to modernize medical care. Attempts were made to professionalize rural health personnel by tightening the screening and supervision of "barefoot doctors." The Ministry formally abolished the title in January 1985. By the end of that year, 40 percent of barefoot doctors had already attained the position of middle medical school graduates (physician assistants) and, upon passing a qualifying examination, were certified as "village doctors" (xiangcun yisheng).[3] The call for modernization provided stimulation for updating and improving urban health facilities. Under Mao, urban interests in health care had been deemphasized, and his death spurred the reemergence of a coalition he had sought to destroy: party cadres, city administrators and the urban medical community, who united to ensure increasing levels of urban care. Ironically, the behavior of rural patients, who bypassed dilapidated township health centers in favor of urban hospitals, reinforced the urban bias in healthcare policy. Responding to the increasing demand for urban health services, the government invested heavily in urban hospitals, resulting in the flow of health resources to the cities. This new urban focus was evident in the demise of Mao's catch phrase "putting the emphasis on rural areas," in favor of the line preferred by the new Minister of Health, Cui Yueli - "equal treatment of the city and the countryside." In practice, this equal treatment policy was only a pretense for urban bias. The National Seventh FiveYear Plan (1986-1990) proposed the addition of 400,000 urban hospital beds, but did not take any remedial measures for the floundering township health centers.[4] The emphasis on economic efficiency also redefined the role of the Chinese government in the healthcare sector. Central party leaders in the early 1980s directed institutions (shiye danwei) capable of generating revenue to operate as enterprises (qiye) responsible for their own profits and losses. To reduce the government's own financial burdens, the Ministry encouraged the coexistence of state, collective, and individual ownership of health institutions. In September 1980, the State Council approved the Ministry's request to permit private practice, which had been phased out during the Cultural Revolution (1966-1976). Buoyed by Cui's criticism of the Maoist model, private clinics flourished in the countryside, and by 1985, had replaced collectively run health stations as the dominant health institution at the village level. The increasing competition from private practitioners saddled township health centers with severe financial problems. With Cui advocating their disintegration, about 42 percent of these centers collapsed in the late 1980s.[5] By endorsing the fee-for-service system, Ministry leaders made their distaste for Cooperative Medical Care an open secret. State subsidies to Cooperative Medical Care dropped rapidly, and in 1987 the government simply stopped its funding entirely.[6] Thus, many of the Maoist rural health programs effectively came to a close by the end of the 1980s. Revenge of Reform

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The health care reforms of the 1980s were characterized by attempts to reduce the role of the state while expanding the functions of the market. At the heart of these policies was the belief that a hardened budget constraint and increased competition would raise economic efficiency and improve access to health care. To be sure, the market-oriented reforms provided people with more alternatives in seeking care, which to some extent alleviated the quality problems inherent in the Maoist health system. Yet the perverse effects of such reform measures were equally glaring. The boom in private practice exacerbated inequality of access in rural areas, and failed at the public health tasks that Maoist system performed so well. Between 1983 and 1990, the number of village health stations rose by 19.2 percent.[7] Yet the proportion of villages lacking a health unit actually increased as well over the same period, from 13 percent to 13.8 percent.[8] Hence, many private clinics failed to fill in the niche cleared by the collapse of collective village health stations. Village doctors practicing on a feefor-service basis had few incentives to trek out to distant villages to vaccinate children or provide prenatal care, preferring to concentrate on more lucrative services. Preventive health and planned immunization were consequently ignored in many areas, leading to the resurgence of infectious diseases.[9] At the same time, market-oriented reforms transformed public health institutions into profit-making machines. With stagnant government subsidies and restrictions on medical service charges, public hospitals sought to maximize revenues through aggressive and loosely regulated drug sales. Between 1985 and 1994, hospitals increased their drug sales by almost six-fold, leading to excessive prescriptions.[10] This problem became even worse in the countryside, where many health units were in dire need of funds and unable to offer new and better services. According to a national health survey sponsored by the Ministry of Health in 1998, 70-80 percent of outpatient fees was spent on drugs in rural areas, compared with about 62 percent in cities.[11] The information asymmetry between health providers and consumers only spurred further overprescription and corruption, completing the transition of health facilities from "institutions" to "enterprises." Such unregulated entrepreneurial efforts drove up the share of private spending in China's health care sector. Between 1978 and 1999, real health expenditures grew at a 12 percent annual rate, outstripping the 8 percent annual growth in real government spending on health. As a result, the share of government spending as a percentage of total health spending dropped from around 32.8 percent to 15.3 percent.[12,13] The government share shrank, despite the lack of a social safety net. The same 1998 survey found that 87.4 percent of the rural population and 44.1 percent of the urban residents were not covered by any medical insurance. This drove up the private share of health spending. In 1998 private spending exceeded the government share for the first time, and in 1999 further expanded to 59.2 percent of health expenditures.[14] With such a dependence on private spending, low-income households faced increasingly restricted access to medical care. Rising medical care costs led to a further deterioration of accessibility. A national survey conducted by the Ministry of Health in 1988 revealed that affordability problems prevented 20 percent of the rural patients from seeking timely outpatient care and 16 Â

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percent of the peasants to be admitted to hospitals seeking inpatient care.[15] The situation only worsened in the 1990s. According to the aforementioned 1998 survey, between 1993 and 1998, the average medical fees per outpatient visit saw an annual growth of 35.5 percent (current price), far higher than the annual income growth. These rising costs consequently deterred many from seeing doctors except in extreme emergencies. About 36 percent of the rural patients in the survey cited "economic difficulties" as the main reason that they did not seek outpatient care. Those afflicted by serious illness were trapped in a vicious cycle of poverty. According to a U.S. study, in 1998, catastrophic medical expenses forced nearly half of China's 60 million poor, defined by the government as earning less than 2 yuan (25 cents) a day, into poverty.[16] Thus, market-oriented health care reforms were detrimental to China's public health by depleting rural areas of health facilities and personnel, promoting unnecessary drug sales as an engine of revenue growth, and requiring private consumers to shoulder the burden of rising health care costs. Back to Mao? In contrast to the determined efforts of the 1980s, the health care reform movement had lost momentum in the 1990s. The political climate following the 1989 Tiananmen crisis, in which the central government crushed a student democracy campaign, opened a window for rolling back some of the market-oriented reforms. In tandem with the onset of a conservative "rectification and consolidation" economic agenda and the purge of the reform-minded party leader Zhao Ziyang, the government targeted private practicing and moonlighting, for cleaning out alleged abuses in health care delivery.[17] More importantly, however, the negative experiences of the 1980s convinced the central leadership of the weaknesses in marketizing health care. In December 1996, the party center formally abandoned the idea of marketizing the health sector by defining China's health care undertakings as "a social public benefit undertakings in which the government implemented certain welfare policies." If we look back at why market-centered reforms were unsuccessful, we see that such reforms were inaugurated when welfare institutions had already been established and internalized, leading to public expectation of a strong government role in the health care sector. Rural and urban fieldwork conducted in the reform era indicates that most respondents believed in the government's responsibility to provide social welfare programs. This notion of entitlement, according to Elisabeth Croll, "is rooted in a rhetorical and practical legacy of state socialism and such expectations of welfare support by the state have been fostered by an increasing sense of insecurity as a result of the rapid pace of market of welfare services and a new sense of inequality."[18] A simple state withdrawal from health care was thus considered a violation of an implicit contract between state and society, a source of disorder and confusion. The entrenched belief in strong government social programs, coupled with the lack of an effective alternative policy paradigm, prevented the post-Mao government from accomplishing a full reversal of the Maoist health policy. Overwhelmed by the problems and complexities in the healthcare reform, policymakers naturally chose to lean heavily on the preexisting policy frameworks, adjusting only at the margins. This path-dependent Â

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feature of China's health care reform was reinforced by the post-Mao bureaucratic decentralization, which allowed some health policy initiatives not favored by the Ministry to find avenues at the sub-national level. As early as 1985, when the Ministry was ardently promoting private practicing by village health workers, 39 percent of the village clinics remained collectively run.[19] By the end of 1987, around 20 provinces had made it clear that collectively run health institutions should be the primary form of village-level health institutions.[20] The local initiatives were then taken by Cui's opponents in the Ministry to justify the policy position of maintaining rural collective health institutions.[21] In January 1988, the new Minister of Health, Dr. Chen Minzhang, formally threw his support to public ownership of health organizations at the village level, although in doing so he seemed to be only underwriting the decisions made at the local level. In 1989, the share of collective village health stations stopped shrinking and started expanding. By the end of 1996, the share of collective village health stations exceeded that of private clinics as the primary form of village health institutions.[22] A similar process can be observed in the rural health insurance system change. While most Cooperative Medical Care plans disintegrated between 1978 and 1983, the remaining 5 percent survived and stabilized in the following years. In some areas where Cooperative Medical Care had collapsed, government-led efforts were made to rebuild the scheme. In other areas, new and affordable insurance schemes emerged to provide modest coverage for preventive care such as childhood immunization. These programs were all based on peasants' mutual cooperation in fund collection, thus bearing the firm imprint of Cooperative Medical Care. The local initiatives, in turn, pressured the central government to clarify its relevant policy position. In 1991, the State Council formally endorsed the rebuilding of Cooperative Medical Care. At the urging of the central government, fledgling insurance plans or cost-sharing programs are being developed, especially in prosperous counties where farm incomes are supplemented by small businesses. The 1998 survey found that by 1997, 22.2 percent of the villages had implemented Cooperative Medical Care. Such developments were apparently encouraged by the new guidelines for health work promulgated in December 1996, which demanded "treating the rural areas as priority." The policy rhetoric of the top leaders in the 1990s suggested that post-Mao Chinese government has formally turned back to Maoist health doctrine, signaling at least a partial reversal of market-oriented reform. Challenges Ahead In their partial readoption of Maoist health policy, Chinese decision makers failed to realize that the success of pre-reform health institutions depended their integration within the politicized landscape. Since the 1980s, however, politically ambitious officials especially those at the local level - have instead been preoccupied with promoting economic growth instead. Situated in a climate biased towards economic development, the current health system is not only ill-prepared for the transition from acute to chronic, non-communicable disease control, but is also increasingly unable to tackle ongoing public health challenges. Infectious diseases remain rampant - about 10 percent of Chinese are still infected with hepatitis B, compared with just 1 percent in the United Â

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States and Japan, with some 30 million people having the chronic variety of the infection.[23] Official documents indicate that 31 percent of the population is infected with TB, claiming one quarter of the world's TB patients.[24] The 1998 national survey finds that Chinese people are actually getting sicker; even controlling for population growth, between 1993 and 1998 the number of patients increased by 304 million, including 1 million who suffer from chronic diseases. In the absence of fundamental changes in the distribution and financing of health care, the health policy structure has become disjoined, incoherent, and particularistic. In 2000, the WHO analyzed the health systems of 191 member countries, ranking China 144th, close to the bottom.[25] This low priority placed on public health may have important implications for the current regime's legitimacy. If legitimacy is classified in terms of the rational justification of state power, there are essentially three types of legitimation: legal-electoral, ideological, and performance-based legitimacy.[26] In view of the dying communist ideology and the official resistance to democracy, the legitimacy of the current regime is performance-based, rooted in delivering economic growth. Chinese leaders assumed that the decline in social services would at least be checked by the trickle-down effect of economic growth. Yet as this article suggests, economic development cannot be automatically translated into corresponding gains in human development. Market-based reform transformed the health sector into a profit-maximizing growth engine, an approach that neglected social needs and worsened health outcomes. Poor health reduces the quality and productivity of the labor force, tempering the economic growth so keenly sought by the central leadership. More importantly, it breeds social discontent, which has the potential to further destabilize the political arena, jeopardizing economic growth. China can still aim for economic expansion, but will need to create a health system dedicated to improving public health for its own sake, in order to gain the social capital and political stability necessary for sustainable long-term development. Yanzhong Huang, Ph.D., is an Assistant Professor of Political Science at Grand Valley State University and a research associate of the Center for East Asian Studies at the University of Chicago.

Endnotes 1. Ministry of Health. Zhongguo nongcun yiliao baojian zhidu yanjiu (Studies on Health Care System in Rural China). Shanghai: Shanghai kexue jishu chubanshe. 1991. 2. Zhongguo weisheng nianjian (China public health yearbook) (1983). 3. Ibid. (1986) 4. Ibid. 5. Jiankang bao (Health daily), 13 January 1991. 6. Zhongguo weisheng nianjian (1989)

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7. Ministry of Health. Zhongguo weisheng tongji ziliao zhaibian, 1978-1990 (Selected edition on health statistics of China, 1978-90). Beijing: Ministry of Health. 1991. 8. Ibid. 9. Jiankang bao, 28 June 1996. 10. State Council Research Office. Wanshan weisheng jingji zhengche (Perfect health economic policy). Beijing: Zhongguo jingji chubanshe. 1996. 11. Ministry of Health. Guojia weisheng fuwu yanjiu (Research on National Health Service). 1999. 12. State Council Research Office 1996. 13. Zhongguo weisheng nianjian (2001) 14. Ibid. 15. Jiankang bao, 23 February 1992. 16. "For Chinese farmers, injury or illness can mean financial ruin", AP, December 31, 2001. 17. China Daily, 18 August 1989. 18. Croll, EJ. "Social welfare reform: Trends and tensions." China Quarterly, 1999. 159: 684-99. 19. Zhongguo weisheng nianjian (1997) 20. Zhongguo weisheng nianjian (1988) 21. Zhang Z. Lun nongcun weisheng ji chuji weisheng baojian (On rural health care and primary health care). Shanxi: Shanxi renmin chubanshe, 1992. 22. Zhongguo weisheng nianjian (1997) 23. Nanfang zhoumu (Southern weekly), 13 July 2001. 24. Zhonguo weisheng nianjian (2001) 25. World Health Organization. World Health Report 2000. 26. Zhao D. "State legitimacy, state policy, and the development of the 1989 Beijing student movement." Asian Perspective, 1999. 23: 245-284.

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Acid Attacks: Bangladeshâ€™s Efforts to Stop the Violence Jordan Swanson Just after midnight on April 16, 2000, 13-year-old Jannatul Ferdous awoke from her sleep with the sensation that an extra linen sheet was being pulled over her body. Seconds later, excruciating pain enveloped her chest and face. A sudden pain jolted the back of her brother, who was sleeping beside her in the small bed. A cup of battery acid thrown through the window engulfed the young girl and her brother as they lay sleeping. The perpetrator was a young man in his twenties, angry that Jannatul had refused his wedding proposals. Jannatul's family had heard about acid attacks on women, but it was not until after daybreak that her parents realized the severity of the situation and took her to a nearby medical clinic in the rural Lakshmipur region of Bangladesh, several hundred kilometers north of downtown Dhaka. The next day she was treated at the Dhaka Medical College Hospital, having spent hours in the waiting room despite her third-degree burns.[1] Approximately 300 people in Bangladesh share Jannatul's experience each year, and 41 percent of victims are under the age of 18. Tragically, the attack on Jannatul was characteristic for several reasons. It is often the case that attacks take place in the middle of the night, that a nearby family member is also victim to the attack, and that the victim does not get quick or adequate medical attention despite his or her urgent need of it. Further, 78 percent of reported acid violence happens to women, with the most common reasons for attack being the refusal of marriage, the denial of sex, and the rejection of romance.[2] Acid attacks leave victims horribly disfigured. Because most attacks are directed at the face in order to permanently scar the victim and destroy her physical appearance, often times the victim is left blinded. Jannatul is considered fortunate with regard to the extent of medical care she has received: she spent ten weeks in the Dhaka hospital and returned in June, 2001 from a year-long stay in Florida to receive special plastic surgery. Despite this care, permanent scars still mar her face. Even after extensive treatment gauges inevitably remain, making social reintegration and marriage very difficult. Victims usually become depressed and are treated as outcasts by family, neighbors, and friends. Despite the frequency of acid attacks and the high traumatic acuity of each, acid violence is a little known phenomenon; what little is known has not resulted in substantially improved care nor a decreased prevalence of attacks. The following pages document a front line investigation of acid violence in Bangladesh and what is being done about it, with subsequent analysis of the current challenges of intervention programs. Acid violence is among the grossest of human rights violations, and the goal of this examination is to focus the debate and the point of intervention in order to more effectively address the problem. This inquiry draws substantially on privileged interviews conducted by the author in June 2001 with survivors of acid attacks, as well as with those Â

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working to help them and to prevent future violence against others A Cheap and Available Weapon A decade ago, acid attacks were committed almost exclusively against women, and only as a crime of vengeance. However, there has been a pronounced increase in acid attacks overall and against men in recent years.[3] Now, nearly 25 percent of reported victims are male. Recently, victims as old as 60 have been targets of this type of violence.[4] A cup of acid, usually sulfuric acid poured from any car battery or purchased from auto repair shops, costs only a few cents, and is therefore both a cheap and available weapon. Some perpetrators throw acid in an attempt to obtain the victim's land, believing that the family will be forced to sell their property in order to pay for medical treatment. A common myth both within Bangladesh and in the external development community holds acid violence to be permanently and historically engrained in Bangladeshi society. Such a perspective is clearly inconsistent with historical evidence. Acid violence was first identified as a problem in the region of Bangladesh in the 1960s.[5] Although acid attacks may have occurred prior to this time, political turnover and a lack of documentation preclude conclusive evidence. Demystifying the notion of intrinsic acid violence, or even gender inequality more broadly, is a crucial first step to enabling the alleviation of this problem.[6] The number of acid attacks increased steadily in the two decades following Bangladesh's independence in 1971, from approximately a dozen each year to about 50 per year in the mid-1990s. But in the late 1990s, cases reported by non-governmental organizations (NGOs) and the government shot up to 250 per year and have leveled off at that point since then. Although both NGOs attribute the steady increase of attacks since 1960 to the increasingly public role of women, neither can explain the explosion of cases in the mid-1990s. Representatives of both NGOs assert that while improved NGO efforts to track cases coincided with the increase in reported cases in the late 1990s, there was a real increase in cases not just an apparent increase due to more thorough coverage. NGOs recognize that some cases do go unreported, but given the strength of the reporting system now in place, it is thought that less than 50 cases go unreported each year, putting the total cases at about 300 annually.[7] The 1990s also saw the arrival of the first strong NGO efforts to counteract acid violence. Naripokkho, formed in 1995, is a women's advocacy organization, and the Dhaka-based Acid Survivors Foundation (ASF), founded in 1999, is an NGO spearheading collaborative work against the attacks. Prior to the late 1990s, the lack of an official reporting infrastructure led to inconsistent tracking of acid throwing incidents and made it difficult to trace acid violence as a countrywide phenomenon, even though acid burns were on the Ministry of Health's list of reportable cases. Tracking the cases should theoretically be very convenient, given that acid violence nearly always necessitates hospitalization and that there are few private facilities in Bangladesh. Although victims sometimes do not see the perpetrator, and at other times do not want to mention his name for fear that he will punish the victim's Â

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family, victims are usually candid in saying that they received the burns from an acid attack. A Broader Problem While acid violence is treated here as a specific, isolatable human rights violation, it is part of a broader type of brutality and cruelty prevalent beyond Bangladesh. Despite the growing number of male victims, the majority of acid violence and certainly its historical roots are seen as a component of a broader phenomenon of gender violence. According to Ivy Rahman, chairperson of the organization Jatiya Mahila Sagstha in Bangladesh, the "attitude of the male-dominating society towards women has to be changed first to put a stop to acid pouring."[8] And although acid violence was initially thought to be a problem endemic to Bangladesh, it is becoming increasingly identified in other South Asian countries. This is consistent with a broader sphere of gender violence. In India, 174 cases were reported in 2000, a per capita incidence of about 1/15 that of Bangladesh, but an absolute number approaching those of Bangladesh.[9] It has been detected also in Pakistan, Nepal, Cambodia, Vietnam, and Laos. ASF has proposed an international workshop for early 2002 to bring NGO and government leaders together to collaborate on a regional effort to combat acid violence. NGO Efforts to Combat Acid Violence Although the specific approach to countering acid violence varies between Naripokkho and ASF, both have a general five-prong approach: public awareness, case reporting, short-term treatment, long-term treatment, and legal justice. Public campaigns have been successful in educating residents throughout Bangladesh about what to do in case of an attack, as well as conveying the importance of finding competent medical care within three days. Further, through interventions such as a program which recently placed acid survivors and national celebrities side by side at a musical concert, NGOs and national media are attempting to inform society about acid violence and the need to accept victims back into society as survivors Ă‘ not to reject them and treat them as outcasts. In an effort to provide medical care for acid victims, the Bangladeshi government established a burn unit at the Dhaka Medical College Hospital. This unit, created in the late 1990s, contains 8 beds and employs 3 plastic surgeons. It is the only burn facility in this country of 130 million people; therefore, it is frequently inaccessible to acid victims. Long delays in medical care have hampered recovery for most past victims, and, once provided, the medicine was very limited in scope. The ASF has been instrumental in establishing a response network that utilizes float-planes and other NGO resources to ensure that victims receive treatment at Dhaka Medical College within three days of the attack, and at no cost to the victim or his/her family.[10] The ASF also created and maintains Thikana House, the only care facility exclusively for acid victims. Currently, Thikana provides limited medical care for less serious burns and follow-up care after surgery. Thikana also offers counseling, skills training, and other rehabilitation programs Â

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to help survivors reintegrate into society. Within two months, Thikana will open a 15-bed surgery unit at the Center for Rehabilitation of the Paralyzed, thereby eliminating dependence on local hospitals. In the last two years, 50% of all attack victims have benefited from the services of ASF.[11] Victims need long-term as well as short-term care, primarily in the form of specialized plastic surgery. In 1999, European donors sent a group of six Bangladeshi survivors to Spain for six months to receive high-quality care. The intervention, while costly, was very successful in raising morale among the survivors being treated. It also offered hope to those survivors in Bangladesh who had not yet received definitive care. Since then, nearly two dozen survivors have traveled to the U.S. and Europe for six to twelve months to receive long-term care. In March, 2001, Healing the Children, a U.S.-based NGO, sent a 9-person surgery team to Bangladesh that performed 34 high-quality plastic surgery operations in 5 days. According to John Morrison, the Executive Director of ASF, as well as the US Embassy in Dhaka, the trip was highly successful from a treatment standpoint.[12] Morrison hopes to bring physicians to Bangladesh again to perform the operations rather than send patients abroad to the U.S. and Europe, becausedoing so would have a much wider impact for the same cost. He hopes eventually to have a resident surgery team at Thikana comprised of foreign physicians who serve temporary tours of service. Prosecution Until recently, perpetrators of acid violence largely went unpunished. According to Dhaka's The Daily Star on 14 January 2001, "participants at an opinion exchange programme on 'social initiatives to prevent acid pouring'... observed that despite the enactment of a new women repression prevention law, such crime continues unabated thanks to lack of proper implementation of the law and negligence by the law enforcing agencies [sic]."[13] However, some victories have occurred in the past several years. Of approximately 750 reported assaults since 1998, 25 perpetrators have been found guilty. A sentence is commensurate with the extent of burning sustained by the victim, and is usually a life sentence or the death penalty. Of the 25 guilty sentences handed down, 9 have prescribed the death penalty in cases where the victim was partially or fully blinded. Punishment is harsh because acid violence is always considered a pre-meditated crime; a perpetrator must plan out the attack in order to obtain acid and sneak up on the victim. According to both ASF and Naripokkho, the judicial system is the key interface in fighting acid violence. Morrison points out that acid violence was rampant in Europe and the U.S. in the 1800s, but died out by the 1840s due to improvements in police forces and the court system.[14] However, the legal system in Bangladesh, especially in the lower levels of courts, is fraught with corruption, political influence, and delays. In July, the annual world corruption rankings compiled by Transparency International named Bangladesh as the most corrupt country in the world.[15] For example, the case brought against Jannatul's assailant has been held up because the magistrate in her district recently decided to take a two-month vacation. Police and attorneys are known to prosecute scapegoats in place of the accused perpetrator if he or his family has political influence.

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Some culprits are able to post bail, despite the severity of their cases.[16] According to Naripokkho officials, a prison warden even directed the execution of a scapegoat who was in prison for a minor crime but loathed by the guards, in place of the real attacker, who paid off the warden.[17] Recently, the Bangladesh National Women Lawyers Association, a partner of ASF, has drafted public interest litigation against easy access to acid and presented it to the Bangladeshi government. Although it is currently under review by the Ministry of Law, progress was hampered by the quintannual national election process, which essentially closed the government for several months before and after the October election. In addition to NGO efforts to publicize the inefficiency of Bangladesh's criminal justice system, foreign diplomatic pressure has progressively addressed acid violence. Urging from British dignitaries during recent meetings in Dhaka and London apparently provoked high-ranking Bangladeshi officials, including the Prime Minister, to personally direct the judicial system to devote attention to particular cases receiving high international visibility. While this is a noble start, political pressure on a case-by-case basis is far from a sustainable solution to a problem that claims hundreds of victims per year. The United States Department of State and the United States Agency for International Development have also been active in promoting judicial expedience and financing police training in basic investigative techniques and evidence presentation in courts. According to U.S. officials, "this sorely needed training is Bangladesh's best hope for bringing criminals to justice, thereby sending a message that no society will tolerate such horrors."[18] Conclusion Acid violence is another horrible chapter in the book of human rights abuses in Bangladesh. The NGO efforts launched in the 1990s have led to significant gains in public awareness campaigns and medical treatment, as well as contributed to the creation of an environment of concern, sympathy, and compassion. One especially positive aspect of efforts against acid violence is that Bangladeshis, especially women, have been a strong driving force against them. Explains Dr. Morrison, "Bangladeshis are outright shocked and ashamed that the attacks happen here."[19] Naripokkho officials agree with Morrison. By a similar token, in a society that has historically oppressed women, it is encouraging to see men vigorously campaigning against a crime that predominantly affects women. ASF reports that for its first nine months of operation, it was sustained solely by donations from Bangladeshi people. Since then, it has reached out to international resources, but indigenous support is very strong. Also, Morrison reports that all but two ASF staff members are female and many are acid survivors. Nonetheless, it is concerning that the work of NGOs has not resulted in a significant decrease in the annual number of attacks in the past several years. This is clearly an indication of the complexity of the problem rather than an implication of unworthy efforts against it. In looking for a conclusive solution, we are guided by the words of Bangladeshi physician Dr. Samonta Lal Sen, who believes that proper treatment can Â

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improve the condition of an acid victim but the loss inflicted is not completely recoverable. "We have no other option than stopping incidents of acid pouring."[20] While the recent increase in the number of convictions is encouraging, Bangladesh still suffers from a poorly trained police force and a backlogged court system, both rife with corruption. Therefore, most perpetrators still go unpunished. If history is a lesson, a marked decrease in acid attacks will not occur until the Bangladeshi police and legal systems become more quick and effective, the prerequisite for which is probably a revolution at the heart of the Bangladeshi political system. Jordan Swanson is an undergraduate at Harvard University.

Endnotes 1. Ferdous, Jannatul. Acid Violence Survivor. Personal Interview. 14 June 2001, Dhaka, Bangladesh. 2. Acid Survivors Foundation. Acid Throwing Fact Sheet. Dhaka, Bangladesh, 2001. 3. Acid Survivors Foundation. Acid Throwing Fact Sheet. Dhaka, Bangladesh, 2001. 4. Morrison, John. Executive Director, Acid Survivors Foundation. Personal Interview. 18 June 2001, Dhaka, Bangladesh. 5. Huq, Nasreen. Executive Director, Naripokkho. With victims and other leadership personnel of Naripokkho. Personal Interview. 14 June 2001, Dhaka, Bangladesh. 6. For related commentary, see an exceptional work by Kenah, Eben. Poverty and the English Language. Senior Thesis, Harvard University. 2001. 7. Morrison, John. Executive Director, Acid Survivors Foundation. Personal Interview. 18 June 2001, Dhaka, Bangladesh. 8. "Gender Gap Cause of Acid Throwing." The Daily Star. 14 Jan 2001. Electronic Source. http://www.dailystarnews.com/200101/14/n1011410.htm. Accessed 13 December 2001. 9. Acid Survivors Foundation. Acid Throwing Fact Sheet. Dhaka, Bangladesh, 2001. 10. Acid Survivors Foundation. Acid Throwing Fact Sheet. Dhaka, Bangladesh, 2001. 11. Morrison, John. Executive Director, Acid Survivors Foundation. Personal Interview. 18 June 2001, Dhaka, Bangladesh. 12. Morrison, John. Executive Director, Acid Survivors Foundation. Personal Interview. 18 June 2001, Dhaka, Bangladesh. 13. "Gender Gap Cause of Acid Throwing." The Daily Star. 14 Jan 2001. Electronic Â

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Source. http://www.dailystarnews.com/200101/14/n1011410.htm. Accessed 13 December 2001. 14. For a brief reference to acid throwing in Europe, see Davis, Jennifer. "A Poor Man's System of Justice: The London Police Courts in the Second Half of the Nineteenth Century." The Historical Journal, Vol. 27, No. 2. (Jun., 1984), pp. 309-335. 15. Transparency International. Corruption Perceptions Index 2001. Electronic Source. Accessed 13 October 2001. http://www.transparency.org/documents/cpi/2001/cpi2001.html. 16. "Gender Gap Cause of Acid Throwing." The Daily Star. 14 Jan 2001. Electronic Source. http://www.dailystarnews.com/200101/14/n1011410.htm. Accessed 13 December 2001. 17. Huq, Nasreen. Executive Director, Naripokkho. With victims and other leadership personnel of Naripokkho. Personal Interview. 14 June 2001, Dhaka, Bangladesh. 18. US Dept of State. Unclassified Cable 2000 Dhaka 1108. 2000. 19. Morrison, John. Executive Director, Acid Survivors Foundation. Personal Interview. 18 June 2001, Dhaka, Bangladesh. 20. "Gender Gap Cause of Acid Throwing." The Daily Star. 14 Jan 2001. Electronic Source. http://www.dailystarnews.com/200101/14/n1011410.htm. Accessed 13 December 2001.

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