Page 17

1
Introduction

It sounds simple: women who drink excessively while pregnant are at high risk for giving birth to children with birth defects. Therefore, to prevent these defects, women should stop drinking alcohol during all phases of pregnancy. Alternatively, women who drink alcohol should not become pregnant unless and until they can control their drinking. More than 20 years ago, when fetal alcohol syndrome (FAS) was first described in the published medical literature, there were high hopes for its prevention. In fact, this has not been simple, and the biomedical and public health communities are still struggling to eliminate a birth defect that should be absolutely preventable.

HISTORY

Although references to the effects of prenatal exposure to alcohol can be found in classical and biblical literature, fetal alcohol syndrome was first described in the medical literature in France by Lemoine et al. in 1968. Researchers in the United States soon also published a landmark report describing a constellation of birth defects in children born to alcoholic women (Jones and Smith, 1973). FAS has since been described in most countries of the world. Briefly, FAS refers to a constellation of physical abnormalities, most obvious in the features of the face (see Figure 1-1) and in the reduced size of the newborn, and problems of behavior and cognition. These latter features lead to the most concern.

The degree of abnormality in any one measure can vary greatly between individuals and can change with time in the same individual. For example,



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 17
Page 17 1 Introduction It sounds simple: women who drink excessively while pregnant are at high risk for giving birth to children with birth defects. Therefore, to prevent these defects, women should stop drinking alcohol during all phases of pregnancy. Alternatively, women who drink alcohol should not become pregnant unless and until they can control their drinking. More than 20 years ago, when fetal alcohol syndrome (FAS) was first described in the published medical literature, there were high hopes for its prevention. In fact, this has not been simple, and the biomedical and public health communities are still struggling to eliminate a birth defect that should be absolutely preventable. HISTORY Although references to the effects of prenatal exposure to alcohol can be found in classical and biblical literature, fetal alcohol syndrome was first described in the medical literature in France by Lemoine et al. in 1968. Researchers in the United States soon also published a landmark report describing a constellation of birth defects in children born to alcoholic women (Jones and Smith, 1973). FAS has since been described in most countries of the world. Briefly, FAS refers to a constellation of physical abnormalities, most obvious in the features of the face (see Figure 1-1) and in the reduced size of the newborn, and problems of behavior and cognition. These latter features lead to the most concern. The degree of abnormality in any one measure can vary greatly between individuals and can change with time in the same individual. For example,

OCR for page 17
Page 18 FIGURE 1-1 Photographs of children with fetal alcohol syndrome. SOURCES: Figures 4C and 4D: Reprinted with permission from Jones et al. (1973). Copyright 1973 by the Lancet Ltd. Figure 4B: Reprinted with permission from Clarren and Smith (1978). Copyright 1978 by the New England Journal of Medicine, Massachusetts Medical Society.

OCR for page 17
Page 19 people diagnosed with FAS can have IQs from well within the normal range to the severely mentally retarded range. The physical anomalies can be slight or quite striking. Some people with FAS live fairly normal lives if given adequate and structured support throughout their lives, whereas others are severely impaired. The defects may or may not be apparent or easily diagnosed at birth. Although the manifestations of the damage might change with age, FAS never completely disappears and, as with many developmental disabilities, there is no cure, although there might be some amelioration in some individuals. FAS does not refer to signs of acute alcohol exposure or withdrawal at birth. Newborns can have blood alcohol levels high enough to affect acutely their central nervous system function and not have FAS. Newborns can also have no alcohol in their bloodstream at time of delivery but still have FAS. FAS is not a "drunk" baby. The costs of FAS and related conditions can be quite high—for the individual, for the family, and for society. Three groups have tried to estimate these costs, and these estimates vary greatly (Bloss, 1994). These estimates are problematic, because of uncertainties regarding the incidence and prevalence of FAS and uncertainties related to the full extent of health (and other) problems experienced throughout the lifetime of people with FAS. Estimates of the occurrence of FAS in North American communities range from 0 per 1,000 (incidence; Abel and Sokol, 1987, 1991) to 120 per 1,000 (prevalence; Robinson et al., 1987), although rates in several of the most complete studies are similar—on the order of 0.5 to 3 cases per 1,000 births. Assuming an annual birth cohort of approximately 4 million, this translates into 2 to 12 thousand FAS births per year in this country. As described in the report, there is a lack of longitudinal data on the extent of possible problems of adults with FAS. Therefore, cost estimates for the United States range from $75 million (Abel and Sokol, 1991) to $9.7 billion (Harwood and Napolitano, 1985). The total lifetime cost per typical case of FAS for a child born in 1980 was estimated to be $596,000 undiscounted1 (Harwood and Napolitano, 1985). These incidence and cost figures are offered not as established facts but they are intended to emphasize that regardless of the details, or any one specific estimate, the costs of FAS to the individual and society are high. Since publication of the papers by Lemoine and by Jones and Smith, the biomedical, public health, research, and public policy communities have devoted much time and energy to a fascinating problem of teratology (the study of the effects of chemical exposure on the developing fetus), neurobiology, disease prevention, and social disarray. The U.S. Public Health Service has spent millions of dollars in research, public education, and service programs related to the 1Discounting is a tool used in economic analyses to assign smaller weights to costs incurred in the distant future. Undiscounted amounts represent simple sums, regardless of when the costs would be incurred.

OCR for page 17
Page 20 topic. Important concepts have been established through research. For example, well-controlled research studies on rats, mice, and nonhuman primates has demonstrated that alcohol exposure causes FAS. However, while alcohol is the necessary teratogen, it alone may not be sufficient to produce FAS in humans or birth defects in animals. As with most teratogens, not every fetus exposed to significant amounts of alcohol is affected. The outcomes might be modulated by numerous biologic and environmental factors, such as nutrition, threshold, timing, genetic susceptibility, pattern of alcohol exposure, or fetal resilience. Further research is needed to fully elucidate the factors that influence the expression of alcohol teratogenesis. Public education campaigns have taught many women and their partners, as well as the medical community and society at large, that excessive alcohol consumption is dangerous during pregnancy. Reduction in the occurrence of substance abuse during pregnancy, reduction in the incidence of FAS, and an increase in the questioning of patients by health care providers about alcohol and other drug use are goals of the Public Health Service's Healthy People 2000 initiative (U.S. Department of Health and Human Services, 1991). See Table 1-1. Prevention of birth defects as a salient public health goal presents some exemplary success stories. A good example is the advocacy for and impact of rubella immunizations for children and women of childbearing age with no history of natural rubella or rubella immunization. An outbreak in the United States in the mid-1960s resulted in an estimated 20,000 children born with congenital rubella syndrome (CRS). CRS occurs in 20 to 25 percent of babies born to mothers who get rubella in the first trimester of pregnancy and results in congenital heart disease, deafness, mental retardation, and other fetal abnormalities. An estimate of the lifetime cost of CRS is about $330,000 per case. With widespread introduction of rubella vaccines in the late 1960s and the requirement for rubella immunization prior to school entry, the number of reported cases of CRS in the TABLE 1-1 Examples of Healthy People 2000 Goals Relevant to Fetal Alcohol Syndrome (FAS) Objective 1987 Baseline Target 2000 Incidence of FAS (per 1,000 live births) 0.22 0.12 Abstinence from alcohol during pregnancy 79% Increase by 20% Screening by obstetrician/gynecologist for alcohol use 34% 75% Referrals by obstetrician/gynecologist for alcohol treatment 24% 75% Screening by obstetrician/gynecologist for drug use 32% 75% Referrals by obstetrician/gynecologist for drug treatment 28% 75%

OCR for page 17
Page 21 United States hit a low of 225 in 1988. As another example, new findings that folic acid deficiency during pregnancy can result in neural tube defects have led to recommendations that grain be fortified with folic acid to prevent these birth defects. Availability of effective prevention strategies led to public policy debates and recommendations for action. The emergence of crack cocaine as a major medical and public health problem in the 1980s led to worries about a generation of crack babies who would cost the medical care system, primarily neonatal intensive care wards, huge amounts of money and who would overburden the education and social service systems with problems attributable to prenatal exposure to cocaine. Further research has shown that crack cocaine can lead to serious obstetrical complications and that some of the exposed newborns do have problems. Cocaine-exposed children have not been followed as extensively or for as long a time as alcohol-exposed children; what data have been published show some effects of prenatal cocaine exposure at three years of age, but the problems do not seem to be nearly as devastating as predicted, nor as severe as the long-term problems associated with alcohol exposure. In fact, some of the long-term effects associated with prenatal cocaine exposure may be due in part to the concurrent use of alcohol during pregnancy. The federal government invested millions of dollars in demonstration projects for services for substance-abusing women. Some of these programs included services for women who abuse alcohol, but the emphasis was usually on drugs, particularly illegal ones, other than alcohol, or on polydrug use. The attention to crack cocaine and its effects on the fetus is curious given that the percentage of pregnant women who drink (approximately 20 percent) far exceeds the percentage who use cocaine (approximately 1 percent; National Institute on Drug Abuse, 1994). At the time, however, the cocaine epidemic and its potential risks to unborn children led to heated public policy debates. Policies of mandatory urine testing in delivery wards, and subsequent removal of a child from the care of a mother who tested positive for illegal substances, were instituted in many places (Blume, in press; Chavkin, 1990). The unintended negative consequences of these actions have led to a reconsideration and reversal of these policies more recently. THE FEDERAL RESPONSIBILITY FOR FAS RESEARCH As will be described in many parts of this report, FAS is a complicated health and social problem, involving many different sectors of the government. The U.S. Public Health Service (USPHS) contains the agencies with primary responsibility for research in the area. The National Institute on Alcohol Abuse and Alcoholism (NIAAA) of the National Institutes of Health (NIH) has the lead role in research on FAS. However, NIAAA is a relatively small institute of NIH. The NIAAA appropriation in 1993 was $177 million, compared with more than $400 million for the National Institute on Drug Abuse (NIDA) and slightly less than

OCR for page 17
Page 22 $2 billion for the National Cancer Institute (U.S. Department of Health and Human Services, 1993). NIAAA programs related to FAS include very basic animal research, which has been the mainstay of research in this area; clinical and epidemiologic research on the effects of low to moderate alcohol use by pregnant women; and prevention research. The alcohol and pregnancy program at NIAAA included $9.8 million to $13.5 million for approximately 70 grants in each of fiscal years 1990-1994. Most of these research grants were RO1, investigator-initiated awards. NIAAA funds one fetal alcohol research center. In addition, many research programs sponsored by NIAAA have ancillary importance to FAS, for example, the research it funds on the epidemiology of drinking by women or on general approaches to the prevention and treatment of alcohol abuse. As an example of the level of commitment by NIAAA to this issue, the prevention research program at NIAAA has ranged from $15 million to $19.8 million annually in recent years. As the lead research agency on alcohol, the institute and the USPHS can serve as a bully pulpit for the prevention of FAS and other alcohol-related problems. In fact, this has been the case. The U.S. Surgeon General first issued a warning against the dangers of alcohol during pregnancy in 1981. In addition to funding and conducting research, NIAAA publishes information for the public on FAS, sponsors research workshops on FAS, and has its staff speak at public meetings. Other NIH institutes fund research relevant to, but not directly about, FAS. For example, NIDA funded a $4 million National Pregnancy and Health Survey on substance abuse, including alcohol, during pregnancy. The data on alcohol were a small part of the entire project. In addition, NIDA funds epidemiologic and clinical research on the effects of substance abuse during pregnancy, and alcohol is frequently one of the substances used by these populations. A rather large study funded by NIDA was the Perinatal 20 demonstration project assessing prevention of substance abuse during pregnancy. Although the major purpose was to look at the abuse of illegal substances, some data were collected on alcohol use, as well. Another key USPHS agency involved in FAS work is the Centers for Disease Control and Prevention (CDC). The FAS Prevention Section is housed in CDC's National Center for Environmental Health, Division of Birth Defects and Developmental Disabilities. CDC's role is to collect data to define the scope of the problem; support the development and evaluation of FAS prevention projects; and build state capacity for coordinated, state-based FAS surveillance and prevention programs (CDC submission to IOM committee). The CDC maintains and analyzes surveillance programs that include FAS, such as the Birth Defects Monitoring Program. In addition, CDC sponsors and supports efforts to prevent FAS. The CDC currently has FAS prevention and surveillance projects supported through states and universities. As with NIAAA, CDC has ancillary programs related to maternal and child health, alcohol abuse, and epidemiologic surveillance that can support and inform FAS programs.

OCR for page 17
Page 23 Other agencies in the USPHS maintain important programs related to FAS, but these programs have much less emphasis on research. The Indian Health Service, the Health Resources and Services Administration (HRSA), and the Substance Abuse and Mental Health Services Administration (SAMHSA) fund services or demonstration projects directly or indirectly related to FAS. At this time, no agency has been able to support research on the clinical aspects of FAS, on the medical treatment of children with FAS, or on the education and remediation of these children. A notable USPHS program is the Pregnant and Postpartum Women and Their Infants (PPWI) initiative. This program was authorized by the Anti-Drug Abuse Act, passed by Congress in 1988. The demonstration grant program focuses on the development of innovative, community-based models of drug prevention, education, and treatment, targeting pregnant and postpartum women and their infants (National Center for Education in Maternal and Child Health, 1993). The program is funded jointly by the Center for Substance Abuse Prevention (CSAP) of SAMHSA and the Maternal and Child Health Bureau of HRSA. It has funded 147 demonstration projects. The most common drug addressed was cocaine, followed by alcohol and polydrug use. Because demonstration projects are rigorously evaluated only infrequently, the nature, utility, and transferability of their findings are difficult to assess. The Center for Substance Abuse Treatment (CSAT), a part of SAMHSA, was charged by Congress to support grants for residential and outpatient substance abuse treatment for pregnant and postpartum women and their infants (information provided to the committee). CSAT funded 31 residential projects in 20 states in the PPWI program and 34 projects in 24 states in its Residential Treatment for Women and Their Children program. The five treatment programs that serve Native American women include comprehensive services specific to FAS. In addition, CSAT has other activities, such as its Treatment Improvement Protocols, relevant to FAS, but the abuse substance of focus is usually cocaine or opiates, not alcohol. CONGRESSIONAL INTEREST In recognition of the seriousness of this problem, which affects both the health and the societal functioning of many Americans, several times in the past few years, members of Congress have introduced legislation related to FAS (see Table 1-2). The bills have focused largely on creating an interagency task force on FAS and increasing resources for prevention programs and prevention research. These bills, with one exception, have never been passed. The U.S. Congress mandated in Section 705 of Public Law 102-321, the ADAMHA Reorganization Act, that the Institute of Medicine (IOM) of the National Academy of Sciences conduct a study of FAS and related birth defects. The National Institute

OCR for page 17
Page 24 TABLE 1-2 Congressional Bills Related to Fetal Alcohol Syndrome (FAS) or Women and Alcohol Bill No. and Date Introduced Bill Name Major Sponsor Overview H.R. 1322 3/7/91 Comprehensive Indian Fetal Alcohol Syndrome Prevention and Treatment Act Campbell (D-CO) Authorize services for the prevention, intervention, treatment and aftercare of American Indian and Alaskan Native children and their families at risk for FAS and fetal alcohol effect (FAE). Authorization of grants to Native American tribes for training, prevention, and intervention programs. Convening of FAS/FAE task force including federal representation and representation from Native American tribes. Would have authorized $10 million annually for FY 1993-1995 and $15 million annually for FY 1996-2000. S. 923 5/7/93 Comprehensive Fetal Alcohol Syndrome Prevention Act Daschle (D-SD) Expand resources for basic and applied epidemiological research related to FAS/FAE. Establish programs to coordinate and support national, state, and community-based public awareness, prevention, and educational programs on FAS/FAE. Establish and facilitate a national surveillance program to monitor the incidence of FAS/FAE and the effectiveness of prevention programs. Establish a task force to foster coordination among federal agencies that conduct FAS/FAE research, prevention, and treatment. H.R. 3569 11/19/93 Women and Alcohol Research Equity Act of 1993 Morella (R-MD) Provide for an increase in the amount of federal funds expended to conduct research on alcohol abuse and alcoholism among women. Would have authorized up to $23,250,000 to enable NIAAA to increase such research.

OCR for page 17
Page 25 H.R. 3783 2/2/94 Comprehensive Fetal Alcohol Syndrome Prevention Act Richardson (D-NM) Establish a comprehensive program to help prevent FAS and FAE and to coordinate federal efforts to prevent FAS and FAE. CDC to coordinate and support applied epidemiologic research on FAS and FAE. NIAAA to conduct and support basic research targeted to developing data to improve prevention and treatment of FAS and FAE. Develop a plan to disseminate diagnostic criteria to health care and social services providers. Establish an interagency task force on FAS and FAE. SAMHSA to support, conduct, and evaluate training programs for professionals; and prevention and education programs for the public. S 170 1/5/95 Comprehensive Fetal Alcohol Syndrome Prevention Act Daschle (D-SD) Establish interagency task force on FAS and FAE. Organize a program of basic research on services and effective prevention, treatment and intervention for pregnant alcohol-dependent women and those with FAS or FAE [Originally introduced as S. 1821 in previous session but died in committee.] H.R. 1649 5/16/95 Comprehensive Fetal Alcohol Syndrome Prevention Act Richardson (D-SD) Establish a program for the conduct and support of research and training and the dissemination of health information about the cause, diagnosis, prevention and treatment of FAS and related conditions. Establish an Interagency Coordinating Committee on Fetal Alcohol Syndrome. Develop uniform criteria for the collection and reporting of data on FAS and related conditions. NOTE: CDC = Centers for Disease Control and Prevention; NIAAA = National Institute on Alcohol Abuse and Alcoholism; and SAMHSA = Substance Abuse and Mental Health Services Administration.

OCR for page 17
Page 26 on Alcohol Abuse and Alcoholism of the National Institutes of Health funded the project. This report is in response to that mandate. The Committee to Study Fetal Alcohol Syndrome was convened in mid-1994. Committee expertise included pediatrics, developmental psychology and neurology, obstetrics, nosology, teratology, epidemiology, sociology, substance abuse prevention and treatment, and psychiatry. The charge to the committee was to improve the understanding of available research knowledge and experience on: • tools and approaches for diagnosing FAS and related disorders, • the prevalence of FAS and related disorders in the general population of the United States, • the effectiveness of surveillance systems, and • the availability and effectiveness of prevention and treatment programs for these conditions. As part of its work, the committee assessed and reviewed U.S. Department of Health and Human Services agency research on the topic and provided guidance for the future. THE COMMITTEE'S FOCUS AND PROCESS The committee understood its charge to focus on the effects of exposure to large amounts of alcohol, that is, on FAS and what had historically been called fetal alcohol effects (FAE). The committee studied data on the relation between low or moderate levels of prenatal alcohol exposure and more subtle psychologic, educational, developmental, and behavioral abnormalities associated with such exposure, but given the currently available data it was unable to conclude that these subtle abnormalities do or do not represent a distinct clinical entity. Thus, the committee concluded that it was inappropriate to develop diagnostic criteria or establish incidence or prevalence estimates for this putative condition. However, some discussion of these data is warranted. Large prospective studies conducted in several U.S. cities, which are described more fully in other sections of this report, have found statistical associations between low to moderate levels of prenatal alcohol exposure (levels not documented or believed to cause FAS) and effects on a variety of behavioral, educational, and psychological tests. These statistical associations are typically weak and the estimated average effects are usually small, so these results seem to have little clinical significance for individual children (Day et al., 1991; Russell, 1991). The population implications, in theory, can be important for the following reasons. First, one interpretation of these results is that the small shift in the average behavioral, educational, and psychological scores in children prenatally exposed to low levels of alcohol theoretically may translate into increases in the

OCR for page 17
Page 27 number of children below low performance thresholds and decreases in the number of children above high thresholds. Second, these weak population results could also suggest that prenatal exposure to low levels of alcohol occasionally but only rarely lead to behavioral, educational, and psychological effects in an individual that do have clinical significance. The clinical significance of small population effects on an individual has not been demonstrated empirically for low-level prenatal alcohol exposure. Finally, these population effects suggest at least a teratologic potential for low-level prenatal alcohol exposure and can provide directions for further research. It is also possible that these effects are spurious, given the difficulties of excluding confounding variables such as stress or nutrition by history alone. Given the current state of our knowledge it is impossible to conclude whether low-level alcohol intake in pregnancy has clinically significant deleterious effects on the individual or not. The committee is cognizant of the grave concern of many pregnant or preconceptional women and their partners about possible effects of less than heavy consumption of alcohol, and it is also aware that this issue has been and will continue to be debated in the lay press. The committee hopes its report will clarify research questions and design issues for further work in this area. The lack of diagnostic criteria for or more definitive statements regarding possible effects of low to moderate exposure to alcohol should not be interpreted as contradictory to the Surgeon General's warning against drinking alcohol during pregnancy. This will be discussed in more detail in Chapter 7. The committee did not establish precise lower limits of alcohol exposure associated with significantly increased risk of FAS. Some researchers have attempted such calculations, but the committee felt that it is premature to make such a statement. Maternal factors such as parity, age, history of heavy drinking, and general health status all influence how much alcohol exposure is necessary for FAS. The level of alcohol exposure is generally very high and likely found in only a small percentage of women who drink while pregnant. Recent data suggest that although approximately 40 percent of all women in the United States are abstinent (Wilsnack et al., 1994), approximately 14 percent of women consume 6 or more drinks at least occasionally when they drink (Wilsnack et al., 1994) and approximately 4 percent of women have alcohol abuse or alcohol dependence problems (Grant et al., 1994). The committee did not establish an incidence or prevalence rate for FAS in the general U.S. population. Rather, the committee reviewed estimates from the scientific literature. Rates in several of the most complete studies are similar—on the order of 0.5 to 3 cases per 1,000 births. The difficulties in determining the extent of the problem are discussed in this report. Clinical experience has accumulated with helping pregnant alcoholic women to decrease their drinking and with helping children with FAS to learn and perform more like unaffected children (Kleinfeld and Wescott, 1993). However, most of this rich clinical literature derives from anecdote and uncontrolled

OCR for page 17
Page 28 projects. As such, it is difficult to distinguish what treatments of either the mother or the child are effective and should be implemented on a larger scale—a potentially expensive endeavor. Therefore, the committee has focused its efforts on reviewing and commenting on the knowledge and experience base that derives from research. As such, the report focuses on NIAAA and CDC. The committee felt it more important to discuss gaps in the knowledge base about FAS and to indicate possible directions for new research endeavors that may ultimately lead to the prevention of what some call the only 100 percent preventable birth defect. The committee met four times for a total of 10 days, reviewed the published literature, and requested and analyzed information from researchers in the field and from relevant USPHS agencies regarding past and future research efforts in this area. Such information included but was not limited to program budgets an d grant and contract abstracts. These were provided by NIAAA and CDC. A major source of information about past work in the area is the published literature. For example, most of the published research using animal models of FAS has been funded by NIAAA. Likewise, CDC-funded work on FAS surveillance is published in Morbidity and Mortality Weekly Reports. Representatives of NIAAA and CDC, who sponsor or conduct most of the USPHS research on FAS, met with the committee at its first meeting, described their programs and subsequently also submitted their vision of their future role in FAS. In addition, much of the published literature on FAS was funded by these agencies and stands as a record of their involvement in the area—many CDC and NIAAA grantees (past and present) were available for consultation by the committee. Several state FAS programs, many of which have some CDC funding, also sent in materials about their programs. Much has been written recently about FAS and related disorders. The Secretary of Health and Human Services submits a special report to Congress every three years on the current state of knowledge about alcohol and health (U.S. Department of Health and Human Services, 1993). These reports contain superlative reviews of the current state of the published scientific literature on FAS research. In addition, during the course of its deliberations, the committee had access to a volume of papers, published by NIAAA (1994), on FAS. Rather than duplicate those efforts, the committee briefly reviews the established scientific literature on FAS where needed and the reader is referred to the sources cited above for background or more extensive information. As such, this report is relatively brief. The experimental literature regarding FAS can be complicated. Research in teratology can be intricate and complex. The report lays out some of the basic principles of teratology and how they apply to the study of alcohol and FAS, particularly with animal models, in Chapter 2. Studies in animals are compelling in the context of the human situation. FAS is important because it is a condition caused by human behavior that affects human health and behavior. The committee has tried to paint a portrait of the wide-ranging human dilemmas involving

OCR for page 17
Page 29 FAS through vignettes in Chapter 3. These are intended to illustrate the scope and impact of FAS more fully than any individual chapter could. To address the many issues raised by FAS, such as ascertaining its prevalence and assessing therapeutic or prevention interventions, it is essential to maintain well-defined diagnostic criteria. In Chapter 4, the committee has elaborated the principles of setting diagnostic criteria and has presented revised FAS diagnostic criteria, which it recommends for general usage. The diagnostic criteria are essential for surveillance and epidemiologic research on FAS. Current challenges in epidemiology and surveillance of FAS are discussed in Chapter 5. Chapter 6 provides an overview of the epidemiology of women's drinking, an understanding of which is crucial for FAS prevention efforts. Chapter 7 discusses FAS prevention, including treatment for maternal alcohol abuse, while Chapter 8 lays the foundation for research in treatment of the child and the adult with FAS. Chapter 9 consists of a brief summary statement and recommendation concerning the integrative nature of FAS diagnosis, surveillance, prevention, and treatment, and how that impacts on research and treatment challenges. SOME IMPORTANT DEFINITIONS Before going further, some clarification of terms is warranted. Several terms are used in this report to refer to drinking patterns and problems. The terms used here are intended to be consistent in spirit with an earlier IOM report Broadening the Base of Treatment for Alcohol Problems (IOM, 1990), particularly in their emphasis on the heterogeneity of alcohol problems, the course of alcohol use disorders, patterns of consumption, and etiology. In this schema, alcohol consumption is seen as ranging from none to light to moderate to heavy. Alcohol-related problems (e.g., medical, legal, social, psychological) also range from none to mild to moderate to severe. Research has pointed to a positive correlation between level of alcohol consumption and level of alcohol problems, with the most severe problems generally seen at the highest levels of drinking. This relationship is, however, variable across individuals; that is, in some cases, severe problems can be seen at comparatively moderate levels of drinking. The fourth edition of the American Psychiatric Association's Diagnostic and Statistical Manual (DSM-IV; 1994) defines alcohol use disorders as alcohol dependence and alcohol abuse. In general, these terms refer to maladaptive patterns of drinking and consequences which constitute a syndrome, usually associated with moderate to heavy alcohol consumption and moderate to severe alcohol-related problems (Edwards et al., 1981; IOM, 1990). In DSM-IV, alcohol dependence is diagnosed when the individual meets three or more of the following seven criteria in a 12-month period: (1) tolerance; (2) withdrawal; (3) drinking in larger amounts or over a longer period than intended; (4) persistent desire or unsuccessful efforts to cut down on drinking; (5) a great deal of time spent drinking or recovering from alcohol effects; (6) declining involvement in social,

OCR for page 17
Page 30 occupational, or recreational activities because of alcohol use; and (7) use of alcohol despite knowledge of a persistent or recurrent physical or psychological problem caused or exacerbated by that use. Alcohol abuse is a less severe syndrome characterized by significant adverse consequences associated with alcohol use and is diagnosed when at least one of the following four criteria is met recurrently during a 12-month period: (1) failure to fulfill major role obligations because of alcohol use; (2) recurrent alcohol use in situations when it is physically hazardous; (3) recurrent alcohol-related legal problems; or (4) continued use despite social or interpersonal problems. In addition, the symptoms have never met the criteria for alcohol dependence (American Psychiatric Association, 1994). Alcohol abuse and alcohol dependence have fairly specific meaning in DSM-IV. However, these terms are frequently used as umbrella terms for maladaptive patterns of alcohol use. In this report on FAS, the committee has chosen to use alcohol abuse as an umbrella term to indicate heavy drinking, including binge drinking, that is risky for the given individual circumstances. If it is clear that a strict DSM-IV diagnosis is intended, it will be so noted. Similar conventions will be used for substance abuse, which is treated very similarly in DSM-IV (American Psychiatric Association, 1994). DSM-IV does not define the term alcoholic, but the National Council on Alcoholism and Drug Dependence does (Morse et al., 1992). Alcoholism, too, is used but only occasionally in this report. It should be noted that there are no specific levels of consumption associated with alcohol abuse, either as used in DSM-IV or as an umbrella term in this report. Survey data from 1992 show that approximately 4 percent of all women and approximately 4 percent of women between the ages of 30 and 44 years of age could be considered to satisfy the DSM-IV criteria for alcohol abuse and alcohol dependence (Grant et al., 1994). As described in the report, the relation between levels and patterns of drinking during pregnancy and the risk of delivering an infant with FAS is complex. In this report, terms such as ''heavy drinking" and "heavier drinking" are used to refer to levels of drinking associated with the highest risk for delivering an infant with FAS. "Binge drinking" is used to refer to a pattern of episodic heavy drinking, which is also associated with higher risk for FAS. Terms such as "risk drinking," or "moderate drinking" are used to indicate lower levels of drinking, usually not associated with FAS, but which may be associated with alcohol-related effects in infants. It is important to note that definitions of these terms have varied across studies, settings, and samples. In particular, operational definitions of terms used to describe the level and pattern of drinking in studies of pregnant women frequently have not corresponded to definitions for women in general, which in turn often do not correspond to definitions for men. For example, a prospective study of the effects of prenatal alcohol exposure defines heavy drinking as an average of one or more drinks per day (Day et al., 1989); a seminal FAS prevention

OCR for page 17
Page 31 intervention project defined heavy drinking as five or six drinks on some occasions and at least 45 drinks per month (Rosett et al., 1981); large-scale surveys of drinking in women usually define heavy drinking as two or more standard drinks per day, where a standard drink contains approximately 0.5 ounce of absolute alcohol); some clinical research projects define heavy drinking in women as four or more drinks per day (Wilsnack et al., 1994), which differs from parallel definitions of heavy drinking in men (six or more standard drinks per day). The lack of consistency in terms regarding level of alcohol consumption across studies has led to confusion regarding the relationship between specific levels of drinking and risk for fetal alcohol syndrome and alcohol-related effects (see Abel and Kruger, 1995 for a review of this problem). The committee defines the relevant history for diagnosis of FAS (see Chapter 4) as one of a pattern of excessive intake characterized by substantial, regular intake or heavy episodic drinking. Evidence of this pattern may include: frequent episodes of intoxication, development of tolerance or withdrawal, social problems related to drinking, legal problems related to drinking, engaging in physically hazardous behavior while drinking, or alcohol-related medical problems such as hepatic disease. REFERENCES Abel EL, Kruger ML. Hon v. Stroh Brewery Co.: What do we mean by "moderate" and "heavy" drinking? Alcoholism: Clinical and Experimental Research 1995; 19:1024-31. Abel EL, Sokol RJ. Incidence of fetal alcohol syndrome and economic impact of FAS-related anomalies. Drug and Alcohol Dependence 1987; 19:51-70. Abel EL, Sokol RJ. A revised conservative estimate of the incidence of FAS and its economic impact. Alcoholism: Clinical and Experimental Research 1991; 15:514-524. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders: 4th Edition. Washington, DC: American Psychiatric Association, 1994. Bloss G. The economic cost of FAS. Alcohol Health & Research World 1994; 18:53-54. Blume SB. Women and Alcohol: Issues in Social Policy in Alcohol and Gender. R. W. Wilsnack and S. C. Wilsnack (eds.). New Brunswick, New Jersey: Rutgers University Center of Alcohol Studies, in press. Chavkin W. Drug Addition and Pregnancy: Policy crossroads. American Journal of Public Health 1990; 80:483-487. Clarren SK, Smith DW. The fetal alcohol syndrome. New England Journal of Medicine 1978; 298; 1063-1067. Day NL, Jasperse D, Richardson G, Robles N, Sambamoorthis U, Taylor P et al. Prenatal exposure to alcohol: Effect on infant growth and morphologic characteristics. Pediatrics 1989; 84:536-541. Day NL, Robles N, Richardson G, Geva D, Taylor P, Scher M et al. The effects of prenatal alcohol use in the growth of children at three years of age. Alcoholism: Clinical and Experimental Research 1991; 15:67-71. Edwards G, Arif A, Hodgson R. Nomenclature and classification of drug- and alcohol-related problems: A WHO memorandum. Bulletin of the World Health Organization 1981; 59:225-242. Grant BF, Harford RC, Dawson DA, Chou P, Dufour M, Pickering R. Epidemiologic Bulletin No. 35: Prevalence of DSM-IV alcohol abuse and dependence: United States, 1992. Alcohol Health & Research World 1994; 18:243-248.

OCR for page 17
Page 32 Harwood HJ, Napolitano DM. Economic implications of the fetal alcohol syndrome. Alcohol Health & Research World 1985; 10:38-43. Institute of Medicine. Broadening the Base of Treatment of Alcohol Problems. Washington, DC: National Academy Press, 1990. Jones KL, Smith DW. Recognition of the fetal alcohol syndrome in early infancy. Lancet 1973; 2:999-1001. Jones KL, Smith DW, Ulleland CH, Streissguth AP. Pattern of malformation in offspring of chronic alcohol mothers. Lancet 1973; 1:1267-1271. Kleinfeld J, Wescott S. Fantastic Antone Succeeds!: Experiences in educating children with fetal alcohol syndrome. Fairbanks: University of Alaska Press, 1993. Lemoine P, Harouseau H, Borteryu JT, Menuet JC. Les enfants des parents alcooliques: Anomalies observees apropos de 127 cas. Ouest Medical 1968; 21:476-482. Morse RM, Flavin DK. The Definition of Alcoholism. Journal of the American Medical Association 1992; 268:1012-1014. National Center for Education in Maternal and Child Health. Prevention of Perinatal Substance Use: Pregnant and Postpartum Women and Their Infants Demonstration Grant Program—Abstracts of Active Projects Fiscal Year 1993. Arlington, VA: National Center for Education in Maternal and Child Health. 1993. National Institute on Alcohol Abuse and Alcoholism. Alcohol Health & Research World—[Special Focus: Alcohol-Related Birth Defects]. Dianne M. Welsh (ed.). 18. 1994. National Institute on Drug Abuse. NIDA survey examines extent of women's drug use during pregnancy. NIDA Media Advisory. Rockville, MD: NIDA, 1994. Robinson GC, Conry JL, Conry RF. Clinical profile and prevalence of fetal alcohol syndrome in an isolated community in British Columbia. Canadian Medical Association Journal 1987; 137:203-207. Rosett HL, Weiner L, Edelin KC. Strategies for prevention of fetal alcohol effects. Obstetrics and Gynecology 1981; 57:1-7. Russell M. Clinical implications of recent research on the fetal alcohol syndrome. Bulletin of the New York Academy of Medicine 1991; 67:207-222. U.S. Department of Health and Human Services. Alcohol and Health [Eighth Special Report to the U.S. Congress]. DC: U.S. Department of Health and Human Services, 1993. U.S. Department of Health and Human Services. NIH Data Book—1993. Bethesda, Maryland: National Institutes of Health, 1993. U.S. Department of Health and Human Services. Healthy People 2000. Rockville, Maryland: U.S. Department of Health and Human Services, 1991. U.S. Public Health Service. Surgeon General's Advisory on Alcohol and Pregnancy. Federal Drug Administration Bulletin 1981; 11:9-10. Wilsnack SC, Wilsnack RW, Hiller-Sturmhofel S. How women drink: Epidemiology of women's drinking and problem drinking. Alcohol Health & Research World 1994; 18:173-181.