TERATOLOGY 41:479-481 (1990)
Letters
Response to Letters Dealing With Warning Labels on Alcoholic Beverages To the Editor: Seegmiller et al. (’87), Willhite et al. (’881, and Brent (’88) have voiced their concern about alcohol abuse in pregnancy and have urged the members of the Teratology Society to support the introduction of warning labels on alcoholic beverages. Brent (’88) indicated that as scientists and teratologists, the Society should support policies which will lead to the prevention of birth defects, a sentiment that is impossible not to support. We would, however, like to express concern regarding the communications of Seegmiller et al. (’87) and Willhite e t al. (’88)and the use of a legislative approach (Willhite, et al., ’88) to address the problem of advice to pregnant mothers on toxic substances. About 60% of the adult female population drink alcohol to some extent. Three percent of the adult female population are thought to be alcohol abusers-drink more than 12 drinks per day (U.S. Dept. of Health, Education, and Welfare, ’78). Epidemiological studies have real difficulties in determining how much alcohol a pregnant woman needs to take for a significant effect on the fetus. This is due to the underestimation of alcohol intake by abusers and nonabusers, which is at least 50% and probably much higher in alcohol abusers (Little, ’81; Russell, ’81). Most of the epidemiological studies which show a n effect of low or moderate intake during pregnancy on offspring are flawed by “lumping.” This is when subjects who drink different amounts of alcohol are considered in a single analysis. The alcohol abusers skew the study to show a higher incidence of abnormalities-adverse reproductive parameters-compared to a nondrinking group. In the example put forward
0 1990 WILEY-LISS, INC.
by Abel(’851, in a group of five women, four of whom consume one drink per day and one of whom consumes six drinks per day, the average intake would be two drinks per day. Increasing the sample size to 50, and again given the same proportions, one can find that ten out of 50 or 20% of the sample would be responsible for the estimated relationship between drinking and abnormality. Studies that narrow the alcohol consumption to one or two drinks or their equivalent per day are reporting averages. This apparently lower level of intake includes women who consume one drink per day for a week and those who consume nothing for 6 days and then have 14 drinks on the last day of the week (Raymond, ’87). When the groups are divided into real per-day amounts, it is in the offspring of the high-intake group that a n adverse effect occurs. Alcohol acts as a “typical” teratogen in animals, inducing a wide range of malformations which vary with the stage of embryonic development a t the time of exposure. This applies whether the exposure has been chronic or acute (acute meaning binge drinking). The level of alcohol to which the embryo is exposed when it is passing through its many critical stages of morphogenesis together with a genotype of the conceptus and mother will largely determine the pattern of congenital malformation. The evidence from animal studies indicates that alcohol acts in a dose-dependent manner with some evidence of a no-effect level when blood alcohol is below 200 mgidl (Webster, ’89). In comparison with other teratogens, alcohol is exceptionally weak, requiring enormous doses in the human to produce ab-
480
A.H. LIPSON AND W.S. WEBSTER
normalities. A typical teratogenic dose in the human may well be above the LD50 for the general population; hence only women with marked alcohol tolerance would be able to consume sufficient alcohol to damage their embryolfetus. The alcohol abuser becomes tolerant to the drug and can easily manage and function with blood alcohol levels above 200 mgidl (Davis and Lipson, '86). Current calls for total abstinence during pregnancy arise from the 1981 report of the Surgeon General of the United States (Surgeon General, '81). The cry to label alcoholic beverages has been more recent (Holden, '86). It must be asked whether advocating abstinence (or implying it) could do more harm than good. Tragically, those women whose unborn children are a t the greatest risk of developing the fetal alcohol syndrome (FAS) are the chronic alcoholic women who will not stop their drinking as a consequence of reading labels or signs or obtaining advice from their doctors (Pierog et al., '79; Streissguth et al., '83). The credibility of such a warning is weakened by exaggeration of possible dangers from relatively small amounts of alcohol. Such a warning in our view is frightening and disturbing. This view is shared by others (Miller, '82; Abel, '85; Rosett and Weiner, '82; Kotala, '81): frightening and disturbing to a woman who finds she is pregnant and remembers she had consumed two or three drinks a week or 2 before and also to a woman who has had a baby with a birth defect or mental retardation or growth disturbance who remembers that she had some drinks during the pregnancy. A campaign advocating abstinence will cause unnecessary worry, fright, and guilt. A common-enough scenario in our experience is for a woman to consider termination of pregnancy on the basis of occasional or light drinking. In addition there may be exaggeration of the mother's guilt if her baby is born with a birth defect or a developmental problem. The recommendation for total abstinence is irrelevant to the mother in these circumstances and warnings (or implied statements) that total abstinence is the only safe course of action
are frightening. As the majority of women are light drinkers and many do not appreciate or find out they are pregnant until 6 to 8 weeks gestation, a large volume of women would be directly exposed to the misrepresentation that any alcohol during pregnancy will be harmful. The use of legal loopholes (Willhite et al., '88) and legislation to establish mandatory warnings on alcoholic beverages (Holden, '86) is not helpful in prevention and runs counter to a scientific evaluation of this problem. Studies have already shown a high level of knowledge in pregnant women about the dangers of alcohol and pregnancy (Fox et al., '87; Streissguth et al., '83). There are no studies showing that labelling would increase this awareness and there is no apparent intention to undertake such studies. We should be honest in evaluating our scientific results and in particular observe the dictum to "first do no harm" to the families and children that we claim to treat or represent. This is by no means implies that the tragedy of a child with a Fetal Alcohol Syndrome should be underestimated. Alcohol abuse is a serious problem in our community. It is the greatest known cause of mental retardation in the Western world (Abel, '86). A communication such a s this cannot cover all the scientific evidence in a structured way. Two of the authors cited by Seegmiller et al. ('87) have expressed similar views to us (Abel, '85; Rosett and Weiner, '82). Members of the Teratology Society and readers of this Journal should not have the impression that the views of Seegmiller et al. ('87) and Willhite et al. ('88)are universal. What should we do about alcohol in pregnancy? It is a problem for all the community. It is a lifestyle problem that requires continuing professional education and the detection and treatment of the at-risk groups-the alcohol abusers. The teratologist may feel better advocating labelling and abstinence and may thus respond to political and social pressures, but such measures are unlikely to reduce the incidence of the Fetal Alcohol Syndrome.
48 1
LETTER TO THE EDITOR LITERATURE CITED Abel, E.L. (1985) Fetal alcohol effects: Advice to the advisors. Alcohol Alcohol., 2Ot189-193. Abel, E.L. (1986) Fetal alcohol syndrome is now a leading cause of mental retardation. Lancet, 2r1222. Brent, R.L. (1988) Editorial comment. Schould alcoholic beverages have warning labels concerning their risks to the developing embryo and fetus? Teratology, 37: 612. Davis, A,, and A. Lipson (1986)Central nervous system tolerance to high blood alcohol levels in chronic alcoholics. Med. J. Aust., 144t9-15. Fox, S.H., C. Brown, A.M. Koonitz, and S.S. Kessel (1987) Perceptions of risks of smoking and heavy drinking during pregnancy: 1985 NHIS findings. Public Health Rep., I02:73-79. Holden, C. (1986) Congress considers warning labels on liquor. Science, 233r517-518. Kotala, G.B. (1981)Fetal alcohol advisory debated. Science, 241:642-643. Little, R.E. (1981) Epidemiological and experimental studies in drinking and pregnancy: The state of the art. Neurobehav. Toxicol. Teratol. 3t162-172. Miller, M. (1982) Prenatal alcohol effect disputed. Pediatrics, 70,322-323. Pierog, S., 0. Chandavasu, and I. Wexler (1979) The fetal alcohol syndrome: Some material characteristics. Int J. Gynecol. Obstet., 46t442-445. Raymond, C.A. (1987) Birth defects linked with specific level of maternal alcohol abuse but abstinence still is the best policy. JAMA, 258:177-178. Rosett, H.L., and L. Weiner (1982) Prevention of fetal alcohol effects. Pediatrics, 69:813-816. Russell, M. (1981) The epidimiology of alcohol related
birth defects. In: The Fetal Alcohol Syndrome, Vol. 11. E.L. Abel, ed. CRC Press, Boca Raton, FL, pp. 93-95. Seegmiller, R.E., J.C. Casey, and R.M. Fineman (1987) The hazards of drinking alcoholic beverages during pregnancy: Should the public be warned? Teratology, 35t479. Streissguth, A.P., B.L. Darby, H.M. Barr, J.R. Smith, and D.C. Martin (1983) Comparison of drinking and smoking patterns during pregnancy over a six year interval. Am. J. Obstet. Gynecol., 145:716-724. Surgeon General (1981) Surgeon General’s advisory on alcohol and pregnancy. FDA Drug Bull., l l t 2 . U.S. Dept. of Health, Education, and Welfare (1987) Alcohol and Health. DHEW 9-10, DHEW, Washington, DC. Webster, W.S. (1989) Alcohol as a teratogen: A teratological perspective of the fetal alcohol syndrome. In: Human Metabolism of Alcohol, Vol. I. R.D. Batt and K. Crow, eds. CRC Press, Boca Raton, FL, chap. 8. Willhite, C.C., A.G. Hendrickx, D.T. Bruk, and S.A. Book (1988) Warnings and the hazards of drinking alcoholic beverage during pregnancy. Teratology, 37: 609-61 1.
ANTHONY H. LIPSON Genetics & Dysmorphology Unit Children’s Hospital Camperdown 2070 Sydney, Australia
WILLIAM S. WEBSTER Department of Anatomy University of Sydney 2006 Sydney, Australia
Letters
Response to Letters Dealing With Warning Labels on Alcoholic Beverages To the Editor: Seegmiller et al. (’87), Willhite et al. (’881, and Brent (’88) have voiced their concern about alcohol abuse in pregnancy and have urged the members of the Teratology Society to support the introduction of warning labels on alcoholic beverages. Brent (’88) indicated that as scientists and teratologists, the Society should support policies which will lead to the prevention of birth defects, a sentiment that is impossible not to support. We would, however, like to express concern regarding the communications of Seegmiller et al. (’87) and Willhite e t al. (’88)and the use of a legislative approach (Willhite, et al., ’88) to address the problem of advice to pregnant mothers on toxic substances. About 60% of the adult female population drink alcohol to some extent. Three percent of the adult female population are thought to be alcohol abusers-drink more than 12 drinks per day (U.S. Dept. of Health, Education, and Welfare, ’78). Epidemiological studies have real difficulties in determining how much alcohol a pregnant woman needs to take for a significant effect on the fetus. This is due to the underestimation of alcohol intake by abusers and nonabusers, which is at least 50% and probably much higher in alcohol abusers (Little, ’81; Russell, ’81). Most of the epidemiological studies which show a n effect of low or moderate intake during pregnancy on offspring are flawed by “lumping.” This is when subjects who drink different amounts of alcohol are considered in a single analysis. The alcohol abusers skew the study to show a higher incidence of abnormalities-adverse reproductive parameters-compared to a nondrinking group. In the example put forward
0 1990 WILEY-LISS, INC.
by Abel(’851, in a group of five women, four of whom consume one drink per day and one of whom consumes six drinks per day, the average intake would be two drinks per day. Increasing the sample size to 50, and again given the same proportions, one can find that ten out of 50 or 20% of the sample would be responsible for the estimated relationship between drinking and abnormality. Studies that narrow the alcohol consumption to one or two drinks or their equivalent per day are reporting averages. This apparently lower level of intake includes women who consume one drink per day for a week and those who consume nothing for 6 days and then have 14 drinks on the last day of the week (Raymond, ’87). When the groups are divided into real per-day amounts, it is in the offspring of the high-intake group that a n adverse effect occurs. Alcohol acts as a “typical” teratogen in animals, inducing a wide range of malformations which vary with the stage of embryonic development a t the time of exposure. This applies whether the exposure has been chronic or acute (acute meaning binge drinking). The level of alcohol to which the embryo is exposed when it is passing through its many critical stages of morphogenesis together with a genotype of the conceptus and mother will largely determine the pattern of congenital malformation. The evidence from animal studies indicates that alcohol acts in a dose-dependent manner with some evidence of a no-effect level when blood alcohol is below 200 mgidl (Webster, ’89). In comparison with other teratogens, alcohol is exceptionally weak, requiring enormous doses in the human to produce ab-
480
A.H. LIPSON AND W.S. WEBSTER
normalities. A typical teratogenic dose in the human may well be above the LD50 for the general population; hence only women with marked alcohol tolerance would be able to consume sufficient alcohol to damage their embryolfetus. The alcohol abuser becomes tolerant to the drug and can easily manage and function with blood alcohol levels above 200 mgidl (Davis and Lipson, '86). Current calls for total abstinence during pregnancy arise from the 1981 report of the Surgeon General of the United States (Surgeon General, '81). The cry to label alcoholic beverages has been more recent (Holden, '86). It must be asked whether advocating abstinence (or implying it) could do more harm than good. Tragically, those women whose unborn children are a t the greatest risk of developing the fetal alcohol syndrome (FAS) are the chronic alcoholic women who will not stop their drinking as a consequence of reading labels or signs or obtaining advice from their doctors (Pierog et al., '79; Streissguth et al., '83). The credibility of such a warning is weakened by exaggeration of possible dangers from relatively small amounts of alcohol. Such a warning in our view is frightening and disturbing. This view is shared by others (Miller, '82; Abel, '85; Rosett and Weiner, '82; Kotala, '81): frightening and disturbing to a woman who finds she is pregnant and remembers she had consumed two or three drinks a week or 2 before and also to a woman who has had a baby with a birth defect or mental retardation or growth disturbance who remembers that she had some drinks during the pregnancy. A campaign advocating abstinence will cause unnecessary worry, fright, and guilt. A common-enough scenario in our experience is for a woman to consider termination of pregnancy on the basis of occasional or light drinking. In addition there may be exaggeration of the mother's guilt if her baby is born with a birth defect or a developmental problem. The recommendation for total abstinence is irrelevant to the mother in these circumstances and warnings (or implied statements) that total abstinence is the only safe course of action
are frightening. As the majority of women are light drinkers and many do not appreciate or find out they are pregnant until 6 to 8 weeks gestation, a large volume of women would be directly exposed to the misrepresentation that any alcohol during pregnancy will be harmful. The use of legal loopholes (Willhite et al., '88) and legislation to establish mandatory warnings on alcoholic beverages (Holden, '86) is not helpful in prevention and runs counter to a scientific evaluation of this problem. Studies have already shown a high level of knowledge in pregnant women about the dangers of alcohol and pregnancy (Fox et al., '87; Streissguth et al., '83). There are no studies showing that labelling would increase this awareness and there is no apparent intention to undertake such studies. We should be honest in evaluating our scientific results and in particular observe the dictum to "first do no harm" to the families and children that we claim to treat or represent. This is by no means implies that the tragedy of a child with a Fetal Alcohol Syndrome should be underestimated. Alcohol abuse is a serious problem in our community. It is the greatest known cause of mental retardation in the Western world (Abel, '86). A communication such a s this cannot cover all the scientific evidence in a structured way. Two of the authors cited by Seegmiller et al. ('87) have expressed similar views to us (Abel, '85; Rosett and Weiner, '82). Members of the Teratology Society and readers of this Journal should not have the impression that the views of Seegmiller et al. ('87) and Willhite et al. ('88)are universal. What should we do about alcohol in pregnancy? It is a problem for all the community. It is a lifestyle problem that requires continuing professional education and the detection and treatment of the at-risk groups-the alcohol abusers. The teratologist may feel better advocating labelling and abstinence and may thus respond to political and social pressures, but such measures are unlikely to reduce the incidence of the Fetal Alcohol Syndrome.
48 1
LETTER TO THE EDITOR LITERATURE CITED Abel, E.L. (1985) Fetal alcohol effects: Advice to the advisors. Alcohol Alcohol., 2Ot189-193. Abel, E.L. (1986) Fetal alcohol syndrome is now a leading cause of mental retardation. Lancet, 2r1222. Brent, R.L. (1988) Editorial comment. Schould alcoholic beverages have warning labels concerning their risks to the developing embryo and fetus? Teratology, 37: 612. Davis, A,, and A. Lipson (1986)Central nervous system tolerance to high blood alcohol levels in chronic alcoholics. Med. J. Aust., 144t9-15. Fox, S.H., C. Brown, A.M. Koonitz, and S.S. Kessel (1987) Perceptions of risks of smoking and heavy drinking during pregnancy: 1985 NHIS findings. Public Health Rep., I02:73-79. Holden, C. (1986) Congress considers warning labels on liquor. Science, 233r517-518. Kotala, G.B. (1981)Fetal alcohol advisory debated. Science, 241:642-643. Little, R.E. (1981) Epidemiological and experimental studies in drinking and pregnancy: The state of the art. Neurobehav. Toxicol. Teratol. 3t162-172. Miller, M. (1982) Prenatal alcohol effect disputed. Pediatrics, 70,322-323. Pierog, S., 0. Chandavasu, and I. Wexler (1979) The fetal alcohol syndrome: Some material characteristics. Int J. Gynecol. Obstet., 46t442-445. Raymond, C.A. (1987) Birth defects linked with specific level of maternal alcohol abuse but abstinence still is the best policy. JAMA, 258:177-178. Rosett, H.L., and L. Weiner (1982) Prevention of fetal alcohol effects. Pediatrics, 69:813-816. Russell, M. (1981) The epidimiology of alcohol related
birth defects. In: The Fetal Alcohol Syndrome, Vol. 11. E.L. Abel, ed. CRC Press, Boca Raton, FL, pp. 93-95. Seegmiller, R.E., J.C. Casey, and R.M. Fineman (1987) The hazards of drinking alcoholic beverages during pregnancy: Should the public be warned? Teratology, 35t479. Streissguth, A.P., B.L. Darby, H.M. Barr, J.R. Smith, and D.C. Martin (1983) Comparison of drinking and smoking patterns during pregnancy over a six year interval. Am. J. Obstet. Gynecol., 145:716-724. Surgeon General (1981) Surgeon General’s advisory on alcohol and pregnancy. FDA Drug Bull., l l t 2 . U.S. Dept. of Health, Education, and Welfare (1987) Alcohol and Health. DHEW 9-10, DHEW, Washington, DC. Webster, W.S. (1989) Alcohol as a teratogen: A teratological perspective of the fetal alcohol syndrome. In: Human Metabolism of Alcohol, Vol. I. R.D. Batt and K. Crow, eds. CRC Press, Boca Raton, FL, chap. 8. Willhite, C.C., A.G. Hendrickx, D.T. Bruk, and S.A. Book (1988) Warnings and the hazards of drinking alcoholic beverage during pregnancy. Teratology, 37: 609-61 1.
ANTHONY H. LIPSON Genetics & Dysmorphology Unit Children’s Hospital Camperdown 2070 Sydney, Australia
WILLIAM S. WEBSTER Department of Anatomy University of Sydney 2006 Sydney, Australia
