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~ ~ ~ ~ ~ ~ hi Changing Consumer Aptitudes The empowerment of certain groups in U.S. society, from minorities to women, from gays and lesbians to health care consumers and patients, has contributed new and distinct voices to the debate surrounding advances in medicine and health policy. Society's Choices: Social and Ethical Decision Making in Biomedicine (1995' ~ s patients, purchasers of health care and health products, and [] subjects of clinical research, consumers are becoming activists. AThey demand and use ~nfo~ation about medical treatments, drugs, and dietary supplements, as well as about the standards that are applied to protect their health through regulatory policies or other gov- ernment actions. Activism will increase as education levels rise and the Internet democratizes access to information- some scientifically sound, some unreliable. Growing numbers of consumers also are be- coming wary of institutions and health professionals arid distrusted of government. These changes In public attitudes and actions offer both opportunities and challenges to public officials at the national, state, and local levels who will shape and manage health care programs. The Institute of Medicine conducts studies that directly assist con- sumers by providing authoritative advice on pressing, and often con- fi~sing, health issues. Consumers also benefit indirectly, as our reports guide health professionals, institutions providing health care services, and federal agencies in designing and managing programs that offer high-quality care and support informed choice. 41

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Informing the Future: Critical Issues in Health Acute Respiratory FailurelMOSF w ith Sepsis MOSF w ith Malignant Condition Cone Lung Cancer Colon Cancer Cirrhosis Congestive Heart Failure Chronic Obstructive Pulmonary Disease Persons ~ 80 Years Old 0 10 20 30 40 50 60 70 80 90 Patients (%) O Able to CorTrr~nicate Conscious Rates of consciousness and the ability to communicate in the 3 days before death as reported by family members of severely ill hospitalized patients. A pa- tient's cognitive abilities may have a significant effect on caregivers, including their inclination to deny impending death or to become more emotionally distant. MOSF = multiple organ system failure. SOURCE: Approaching Death: Improving Care at the End of Life, 1997; page 43. SUPPORTING CONSUMER CHOICE Just as more people are paying attention to the quality of their lives, they also are becoming increasingly concerned about how they may die. Approaching Death: Improving Care at the Erldt of fife (~1997) focuses on the numerous complex is- ~Just as more people are paying sues that face people who are dying, attention to the quality of their their families, and their caregivers. lives, they also are becoming The report presents what we know increasingly concerned about how about care at the end of life, what we they may clie. have yet to learn, and what we know 42

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Changing Consumer Attitudes but do not adequately apply. It seeks to build understanding of what constitutes good care for the dying and offers recommendations to policyrnakers that address specific barriers to achieving good care. More than I.5 million women in the United States have silicone breast implants. Most of these women say they are very satisfied with their implants, but some women have experienced complications that require sur- gery or even removal of the implants. Others claim that their implants have caused even more serious health problems. Safety of Silicone Breast Implants (2000) evaluates the evidence for associations of these devices with human health conditions. Implants do not appear to cause major diseases of the whole body. Problems with implants appear to be local, but not life-threatening, com- plications. Dunng the early years of breast implants, women considenng surgery often were not given much information about possible complications or the likelihood that the implants would not last forever. ~~W ..-...-.. Hi. I,..,. : ..... -;,.,. ,~ ~ .~ ~ IF Can marijuana relieve health problems? Is it safe for medical use? Public opinion on the medical value of manjuana has been sharply divided, with proponents on both sides citing "scientific evidence" to support their views. Marijuana andt Medicine: Assessing the Science Base (1999) reviews the science behind manjuana's actions aIld ex- amines the efficacy of therapeutic uses of manjuana. The report finds that can- Public opinion on the medical nabinoid drugsthat is, drugs that act in value of marijuana has been ways similar to the primary active in- sharply divicled, with proponents gredient in marijuana may have a role on both sides citing "scientific to play in medicine in such areas as pain eviclence" to support their views. relief and appetite stimulation. Yet, for several reasons, the fixture of cannabinoid drugs lies not in smoked marijuana but in chemically defined drugs whose actions can be bet- ter controlled. To cover the penod until such drugs are available, the report calls for continued basic research and for clinical trials under limited circumstances and with strict oversight. 43

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Informing the Future: Critical Issues in Health For each of these three reports, the lOM has produced consumer- onented surnmanes to help members of the general publicespe- cially individuals and their families who face or expect to face such issues understand the scientific facts and the available options. PROVIDING AUTHORITATIVE ADVICE Better information about food and nutrition can help improve con- sumer choices. Numerous reports by our Food arid Nutrition Board have established the recommended daily intake levels of vitamins and minerals and the maximum levels of nutrients which pose no risk of adverse effects due to overconsumption. Changes in food labeling laws, the use of nutrient recommendations in determining minimum levels of foods provided in public and private programs, and other recent developments point to a need for a Better information about food comprehensive approach to reviewing cur- and nutrition can help improve rent dietary recommendations. A series of consumer choices. IOM reports on Dietary Reference Intakes (DRIB) provide quantitative estimates of nutrients individuals need to optimize their health, prevent disease and deficiencies, arid avoid adverse affects due to consuming too much of a nutrient. DRIs have been developed for a variety of vita- mins and minerals; macronutnents, such as protein, fat, and carbohy- drates; trace elements, such as iron and zinc; and antioxidants, such as selenium. DRIs for water and electrolytes, such as sodium and potas- sium, and for other food components, such as fiber and phytoestro- gens, are in the process of being reviewed and developed. The number of Americans who use complementary and alterna- tive medical therapies has grown rapidly in recent years. With in- creased use comes increased need for scientific investigation and un- derstanding of whether these therapies are safe and effective. The lOM is reviewing complementary and alternative therapies used by the American public. In addition to examining issues of safety and effectiveness, the report will explore whether people using these therapies delay seeking conventional treatments, differences in how diverse cultural and ethnic groups use these therapies, how open and 44

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Changing Consumer Attitudes under what conditions physicians make referrals for these therapies, and the extent that insurance companies pay for them. Of the many interventions that appear to be important in preserv- ing and maintaining physical arid mental health in older women, hor- mone replacement therapy has attracted the greatest interest. The lOM plans to review the current science related to hormone replace- ment therapy. The resulting report will address issues regarding dos- age, delivery mechanisms, and timing of initiation and cessation of therapy to maximize health outcomes and reduce adverse effects. It also will examine the role of hormone replacement therapy as part of a comprehensive health promotion and disease prevention program, when combined with other healthy behaviors, such as diet, exercise, and weight control. For nearly 50 years, public concern and scientific de- bate have surrounded the program of aboveground nu- clear weapons testing that the United States conducted in Nevada dunng the period from 19S] to 1962. Concern about radioactive fallout north and east of the Nevada Test Site began to emerge soon after weapons testing be- gan. During the late 1980s, the National Cancer Institute INCH began assessing the level of radiation exposure that Americans may have received from radioactive iodine released dunng atomic bomb tests, and NCT later issued a report with this information. The NOM/NRC report Expo- sure of the American People to Iodine-131 from Nevada Nuclear-Bomb Tests: Review of the National Cancer In- stitute Report and Public Health Implications (1999) provides art evaluation of the soundness of the methodologies used by the NCT to estimate past radiation doses, detect possible health consequences of exposure to iod~ne-13l, identify implications for clinical practice, arid construct possible public health strategies to respond to the exposures, such as systematic screening for thyroid cancer. The report also pro- vides an evaluation of the NCI estimates of the number of thyroid cancers that might result Tom the nuclear testing program and offers guidar~ce on approaches the U.S. government might use to communi- cate with the public about iodine-13 1 exposures and health risks. EXPOSURE UF THE AA,ERICAS PEOPLE TO IODINE-] 31 FB851 NEVABA \IUCLEAR-B8~MB TESTS 45

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Informing the Future: Critical Issues in Health EXPOSURE RISK ASSESSMENTS Veterans, they relatives, and their representatives have long been an active voice arguing for more infonnation and for a larger say on issues that affect their health. The TOM has conducted a number of studies designed to assess the health effects on Unitary personnel and civilians of exposure to toxic substances during deployment ~ themes of war or proximity to nuclear weapons testing. Congress, veterans groups, and These studies not only provide the other interested parries have relied government agencies that request them upon the lOM to provide authorita- with the latest scientific information and evaluations, but also serve as ~bi- tive assessments of these risks and what is known about their ased sources of information for the in- consequences. dividuals whose health may have been jeopardized by their service or by de- fense weapons production. A legacy of cold war secrecy is the con- tinliing distrust of the gove~nment's honesty in assessing and revealing these nsks. Congress, veterans groups, and other interested parties have relied upon the TOM to provide authoritative assessments of those risks and what is known about their consequences. Among the studies, Veterans at Risk (1993) assessed the long-tenn health consequences among World War II veterans of exposure to mustard agents. A series of studies, beginning with Veterans arid Agent Orange: Health Effects of Herbicides Used ir' Vietnam (~1993), has focused on exposure to herbicides (and their contaminants, nota- bly dioxin) used during the Vietnam War. We currently are working on Update 2000, the fourth volume in this senes. Gulf War Veterans: Measuring Health (1999) examined He evidence of adverse health effects from exposure to certain chemicals, drugs, and vaccines known to be present dunug the war in the Persian Gulf. Much remains un- known about such effects, and we now have a major study ureter way to assess exposures to 33 toxic agents that Gulf War veterans may have encountered dunug their service. All U.S. military personnel now are vaccinated against anthrax. The first service-related vaccinations occulted in 199~199l, when reports that Iraq had produced weapons containing anthrax spores 46

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Changing Consumer Attitudes during the Gulf War fi~eled fears of the potential use of anthrax as a biological weapon. Since vaccination became the official military pol- icy in ~ 99S, some soldiers and other observers have expressed concern about the safety of receiving the vaccine. The TOM has two studies un- der way to evaluate the health risks associated with anthrax vaccine. The Safety and Efficacy of Anthrax Vaccine for the U.S. Military, re- Sincevaccination [against anthrax] quested by the Department of De- became the official military policy in fense, will examine such issues as the 199B, some soldiers and other types and seventy of adverse reac- observers have expressed concern lions, including gender differences; about the safety of receiving the long-term health implications; effi- vaccine. cacy of the vaccine against all known anthrax strains; validation of the manufacturing process; and gaps in existing research. Review of the CDCAr~thrax Vaccine Safety and Effi- cacy Collaborative Research Program will advise the Centers for Dis- ease Control and Prevention on the completeness and appropriateness of its proposed plan for assessing the range of issues related to ensuring safe and efficient use of the vaccine. 47

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Seiectec! Recommendations for Behavioral and Social Science . . . Investments in Young Children: The president should establish a task force to review all public investments in childcare and early childhood educa- tion, with the goal of making the most of scientific knowledge about early childhood. The task force should be charged to develop a 10-year plan that focuses on ways to foster sustained relationships between preschoolers and qualified caregivers; that addresses the special needs of children with devel- opmental disabilities or chronic health conditions; and that ensures that all child-care settings are safe, stimulating, and responsive to families' concerns. Further, the major current sources of funding for childcare and early educa- tion should support initiatives aimed at increasing the qualifications, pay and benefits of child-care professionals. (From Neurons to Neighborhoods: The Science of Early Childhood Developmenfl Interdisciplinary Research and Training: Because behavioral change is complex, successful intervention efforts are similarly complex and require the contributions of behavioral and social sciences, clinical medicine, and genet- ics, as well as other fields such as education. Advances in the behavioral and social sciences depend upon research that draws on multiple disciplines. Training programs need to provide scientific breadth to encourage work across disciplinary boundaries. The NIH and other federal research agencies should implement peer-review procedures that facilitate cross-disciplinary efforts and require universities to implement supportive policies for scientists working across disciplines. (Bridging Disciplines in the Brain, Behavioral, and Clinical Sciences) . Focus on Minorities: The newly established program of behavioral and so- cial science research at NCI addresses an area of research that has been neglected in the past. The program should identify as one of its highest pri- Orities a focus on cancer prevention, control and treatment needs of ethnic minority and medically underserved groups. (The Unequal Burden of Cancer: An Assessment of NIH Research and Programs for Ethnic Minorities and the Medically Undersexed Social and Behavioral Determinants of Health: Social and behavioral factors have a broad and profound impact on health across a wide range of conditions and disabilities. A better balance is needed between the clinical approach to disease, presently the dominant public health model for most risk factors, and research and intervention efforts that address generic social and behavioral determinants of disease, injury, and disability. (Promoting Health: Intervention Strategies from Social and Behavioral Research)