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Paternalism and policy Kari Poikolainen, University of Helsinki, Finland Drugs and Alcohol Today, Publication date: 23 September 2020 https://doi.org/10.1108/DAT-07-2020-0048

Abstract Purpose - To investigate to what degree scientific evidence supports contemporary paternalistic alcohol policy practices targeting fully competent adults.

Design/methodology/approach - Paternalism may be acceptable if it is effective, fair and protects the safety of the citizen or a third party from the harms caused by the citizen's autonomic actions. To be justifiable, paternalistic actions should bring about clearly more benefits than harms. Otherwise autonomy should prevail. The evidence related to alcohol control policies is assessed against these principles.

Findings - In peaceful civilized societies alcohol control policies (high prices, restrictions on supply and marketing) have no or only insignificant effectiveness. Some policies are unfair and may bring about more harms than benefits. There is strong evidence showing that brief interventions aiming to reduce alcohol intake are inefficient. Wide-scale screening for such interventions is likely to waste health service resources. There is sufficient evidence to refute the claim that the above policies are effective measures to reduce alcohol-related harms. Heavy alcohol use during pregnancy and driving motor vehicles while intoxicated may bring about harm to others than the user. Behavioural interventions to reduce heavy use in pregnancy have been shown to be inefficient. Light alcohol use may have no harmful effect on the developing embryo while heavy use is likely to cause harm. There is moderate evidence for enforcing legal blood alcohol concentration limits to reduce traffic accidents and fatalities.

Originality - This is the first review on the acceptability of paternalism in currently recommended alcohol policies. It shows that in only a few cases paternalism is effective and compatible with freedom and fairness.

Keywords Alcohol policies, Efficiency, Fairness, Freedom, Paternalism, Autonomy Paper type Research paper

Introduction What kinds of paternalism are acceptable in alcohol policy? Has the state the right to interfere with the adult citizen's alcohol use? What types of interference might be fair? Has the state the right to lie in order to protect its citizens? Have health authorities similar rights to the state? These are serious, difficult and often neglected questions. I shall first set up the background and criteria for acceptable paternalism, then review the evidence related to alcohol policies supporting or refuting paternalism and finally discuss the appropriate role of paternalism. The state is parens patrie of its population. Like a good father and mother its duty is to take care of those in need of help. The state keeps order and protects the weak, infirm and handicapped. In the parent-child and caregiver-patient relationships paternalism has an important role to play. However, the extent of paternalism is always debatable and can be criticized, depending on particular historic, cultural and social circumstances in various countries. In spite of this, the prevailing view on alcohol policy focuses on global and universal measures to diminish alcohol- related problems. Good parents also give as much freedom as possible to the adults of the family. Fully competent citizens should have as much autonomy as reasonable and possible. For them, the balance between actions of authority and autonomy of the citizens must be carefully considered (Dworkin, 2020). Focusing on this adult population, paternalism will be appraised. In my view, paternalism may be acceptable if it is effective and fair, if a paternalistic action protects the safety of a third party and if paternalistic actions clearly bring about more benefits than harms (proportionality principle). Otherwise autonomy should prevail. The proportionality principle implies that weighing the pros and cons should take account of the values of the citizens in addition to the aforementioned criteria. Harm to others requires to be clearly established, as for example in the transmission of serious contagious disease. Paternalism is not acceptable if all it does is weaken the citizen's own welfare. Citizens should have the right to live according to their own values. This is the liberalistic view, supported among others by the champions of the Enlightenment, Immanuel Kant, John Stuart Mill, Benjamin Constant and Alexis de Toqueville. In our times, the Ottawa Charter on health promotion has endorsed empowerment of citizens, defending their rights against coercive paternalism (WHO, 1986).

Findings Target 1: the whole adult population State alcohol policies aim to protect citizens from harms due to alcohol intake. The paternalistic aim is to improve the welfare or good of the citizen even against his own will. The “nanny state” knows what is best for the citizen: all citizens should drink as little alcohol as possible, preferably none, in order to avoid alcohol-related harms. To this end, it applies the following measures: to reduce any alcohol intake by high alcohol prices (excise tax, minimum price laws), restrictions on the supply (availability) of alcohol (restrictions on hours of on- and off-premise sales, mail order sales, sales to underage persons and intoxicated ones), and marketing (restrictions on advertising, discounts and free samples). All these efforts go under the name population alcohol control policies. We should ask which, if any, of these measures are effective and fair. A common belief in some academic and administrative circles is that the above measures are effective. World Health Organization endorses these ideas stating that “the most cost-effective actions to reduce the harmful use of alcohol include increasing taxes on alcoholic beverages, enforcing restrictions on exposure to , and restrictions on the physical availability of retailed alcohol” (WHO, 2010, 2020). The above view was put together originally from three types of findings: 1) the distribution of alcohol consumption was found to be roughly lognormal in surveys of various population samples, 2) higher price and restricted availability of alcohol decreased alcohol consumption in some populations and 3) alcoholics had higher mortality than the general population after treatment. The conclusion was: if the consumption is decreased in a population then alcohol-related harms will decrease (Bruun et al., 1975). In this argument, there are several errors and weaknesses. The effects of population alcohol control policies on per capita alcohol consumption. In Italy, France and Spain, decrease in alcohol consumption started years before the first control policy measures were implemented (Allamani et al., 2014). Some effect on alcohol consumption has been observed in some studies but others have not found any effect (Wagenaar et al., 2009, Dumont et al., 2017). The effect or lack of effect varies between studies and depends on what selected population groups have been studied and how alcohol consumption has been measured (Nelson and McNall, 2017). It is noteworthy that heavy drinkers and alcoholics are influenced less than the rest (Ayyagari et al., 2009, Wagenaar et al., 2009). The effects of population alcohol control policies on various types of harm. To find out the effects of changes in price and restrictions and other control policy measures, before-and-after studies, including time-series studies, are commonly carried out. No consistent picture emerges when these studies are reviewed; the types of harms under study vary; there are studies on liver disease, composites of alcohol-specific diseases and injuries, hospitalizations and deaths from the aforementioned outcomes, crimes and other harms. For all the studies that have found some positive association of control policies there is at least an equal number of studies that have found no association or negative one (Nelson and McNall, 2016). This is understandable since most studies have several deficiencies (Poikolainen, 2020). One probable reason is that drinking habits and patterns (not usually measured) are more important than the average alcohol consumption in determining the harmful consequences. Another is that cultures change slowly, driven by inputs and processes nobody really understands (chaos theory, emergence). Inputs that have much impact at certain point in time may have no impact at all in different situations. The evidence for positive effects of comes largely from before-after comparisons in populations suffering from some undesirable circumstances. These include repression by totalitarian regimes, catastrophes, war, economic crisis and famine. In 1917, Denmark was not in a state of war but because of a grain shortage, large tax increases on alcohol were enacted. These were followed by big decreases in mortality from alcohol psychosis and poisoning. During World War II, liver mortality decreased sharply in Paris when wine was rationed during the occupation of France. During in the USA in 1920-1933, liver cirrhosis mortality decreased while crime and drunkenness increased.. In the Soviet Union, mortality decreased for the first three years of the glasnost temperance campaign which decreased alcohol availability. Then the backlash kicked in. More and industrial alcohol, laced with toxic substances, was consumed (Poikolainen, 2020). Mortality was higher after than before the reform (Leon, 2011). Fortunately, many of these "natural experiments" are but history. But who can say that such calamities may not await some populations in future. To get a comprehensive and up-to-date picture of the relation between restrictions and harms it is best to focus on the number of disability-adjusted life years (DALYs) lost due to alcohol. DALYs are composites of the number of years lost due to ill-health, disability and premature death. One DALY equals one lost year of healthy life. In civilized societies and under normal conditions, stringent alcohol policy, gauged by the Alcohol Policy Index, did not correlate at all with the number of DALYs lost due to alcohol. Moreover, the rate of excise tax on alcoholic beverages was not related to alcohol-related DALYs (Poikolainen, 2016). This study had several strengths: a comprehensive outcome measure, control of confounding built into the risk estimates attributed to alcohol, either derived from studies adjusting for confounding factors or from judgements by the cause-of-death examiners, and high power because R2 was large and the number of explanatory variables limited. In contrast to the general belief in the usefulness of restriction of alcohol advertising, a recent systematic review of randomized controlled trials (RCTs) and other studies found no robust evidence that banning or restricting marketing would decrease alcohol consumption. The evidence from RCTs in this systematic review was rated as very low (Siegfried et al., 2014). To sum up, the evidence shows that in normal civilized societies alcohol control policies have no or little effectiveness There is sufficient evidence to refute the claim that increasing taxes on alcoholic beverages, enforcing restrictions on exposure to alcohol advertising, and restrictions on the physical availability of alcohol are effective measures to reduce the harmful use of alcohol. Are population alcohol control policies fair? Most cohort studies have shown that moderate drinkers have lower mortality than lifelong abstainers while the mortality rate of heavy drinkers exceeds that of the former two groups, with similar findings for several diseases. The highest risk of death is among alcoholics, or those with using current diagnostic criteria. To my knowledge, there are only two studies that have distinguished between alcoholics and other groups of drinkers. Compared with lifelong abstainers, subjects both with (DSM-IV alcohol dependence criteria) and a daily average alcohol intake of four standard drinks or more had a 1.65-fold risk of death in the USA. There was no material difference in mortality between lifelong abstainers and very heavy drinkers who were not alcoholics, even if their long-term daily average drinking level was approximately equal to that of alcoholics (Dawson, 2000). A large Swedish study has found similar results (Lundin et al., 2015). It is not only the amount consumed but also the context, rhythm and speed of drinking that is associated with negative outcome. Moreover, randomized controlled trials have shown that moderate drinking brings about favourable changes in biological risk factors relevant to some major diseases and causes of death (Poikolainen, 2020). It seems inequitable that moderate drinkers are subjected to the same high taxes and restrictions as abusers of alcohol. Stringent alcohol policies may force moderate drinkers to decrease their intake more than heavy drinkers and alcoholics. Under such policies the latter two groups are likely to favour cheap alcoholic beverages, self-made spirits and surrogates like industrial ethanol products, which may contain methanol or other highly toxic substances. Thus, stringent alcohol policies are not fair and moreover, they are counterproductive because both the health benefits and revenue from alcohol taxes will be reduced when moderate drinkers, influenced by high prices, decrease their intake. Nudges. A soft form of paternalism is the so-called nudge: the choices are presented in such a way that people were more likely to choose options that are thought by the nudger to be best for them. For example, bottles of smaller sizes could be displayed in front of the larger ones in shops, bars could favour small serving sizes and restaurants offer tiny bottles on the wine lists. For the nudger, the smaller the serving, the better. It is difficult to identify nudges to promote moderate alcohol intake. While warning labels have often been proposed these pose at least three problems. First, since moderate drinking is beneficial and heavy intake harmful a simple 'no' will not be truthful. Hence, long messages are required, but there is not enough room in most bottles and other containers. Thirdly, although warning labels are sometimes noticed and read they have not been found to affect behaviour (Stockwell, 2006).

Target 2: the high-risk subjects and situations Screening and brief interventions are often advocated as a way to decrease heavy drinking. The idea is to ask the users of health services how much they drink and advise those drinking over a certain risk level to cut down. But there is no consensus about what is an appropriate risk level. The newer the recommendation, the lower it seems to be. The actual harmful level for various health outcomes is not known and probably impossible to ascertain with reasonable accuracy by the measures currently available. However, a large body of evidence suggests that the usually proposed risk levels are too low (Poikolainen, 2020). This raises the suspicion that adopted very low risk levels are a conspiracy against the common man, an example of a "noble lie", put forward because the well- meaning authorities are afraid that if you give the devil a little finger he'll take the whole hand and therefore dishonesty will be the best policy. This kind of cynical attitude towards the competence of the common man has a long history, starting at least from Plato's Republic (380 BC). In civilized societies, the public have the right to know the scientific truth. The best current evidence, including its uncertainty, should be presented as completely as possible, without purposeful selection and bias. It is known that the way information is being presented influences the conclusion drawn, the so called framing effect. Both lay people and physicians are susceptible to framing (Perneger and Agoritsas, 2011). The advice to cut down is typically given by physicians or nurses in short sessions known as . Randomized trials have shown that the effectiveness of these interventions is minimal in ideal conditions and trivial in normal health care practice. A Cochrane review and meta‐analysis including 34 RCTs found that participants who received brief intervention consumed only 3 g/day less alcohol than minimal or no intervention participants after one year according to self-report (Kaner et al., 2018). There was no difference in the gamma-glutamyltransferase levels, a test that correlates with alcohol intake. An observational study in the USA found that brief intervention based on AUDIT-C scores was not effective in real-world conditions (Williams et al., 2014). Large scale application of brief interventions will waste heath care resources and cause unnecessary worry among the patients (Poikolainen, 2020). It is not fair that a help-seeking patient will be interrogated about a topic unrelated to the present complaint before he or she can get to the point of their visit or treatment. Screening and brief interventions are ineffective and unethical. Pregnancy. In contrast to passive smoking there is no similar case of passive drinking. The only exception is pregnancy. The developing embryo is exposed to the mother's alcohol intake, and if the intake is substantial the risk of adverse fetal health outcomes is high. Suggestive scientific evidence of fetal damage this was first published in France in the 1960's (Lemoine et al., 1968). Alcohol exposure during pregnancy can cause growth deficits, low birth weight, congenital anomalies and cognitive deficits. However no studies have shown that that light alcohol intake is related to any of these impairments. Congenital anomalies are also called malformations, dysmorphic features or abnormalities and are therefore birth defects or congenital disorders. One meta-analysis focused on facial and brain anomalies thought to be alcohol-related. In data on over 130,000 newborn, there was no difference in the incidence of anomalies between abstaining mothers and mothers with an alcohol intake of 24-168 g/week (Polygenis et al., 1998). No differences in birth weight were found between mothers drinking below or above the level of 35 g/day (Kaminski et al., 1978). A meta- analysis found that drinking 12 g/day or less was not related to birth weight or to premature birth (Henderson et al., 2007). Premature births were not significantly more common at the intake level of 24-168 g/week compared with abstaining (Makarechian et al., 1998). In a combination index of motor, language and cognitive performance, no material differences were found between children born to mothers who abstained or consumed alcohol during pregnancy (Testa et al., 2003). Compared with never-drinkers during pregnancy, maternal intake of 8-16 g/week was followed by better cognitive ability among boys at the age of three, five and seven years. The boys were more mature and showed less hyperactivity or conduct problems (Kelly et al., 2013, Kelly et al., 2012, Kelly et al., 2009). Another prospective study found that there was no association between moderate drinking during pregnancy and executive function ratings in the offspring ( Skogerbø et al., 2012). For low birthweight, preterm birth and small for gestational age, a dose-response relation has been found, showing increased risk with heavy use and no risk with light use (Patra et al., 2011). As a result, the risk level is unknown. Because of this, some authorities recommend total abstinence during pregnancy even though many studies have failed to show that light drinking is associated with any harm to the unborn. In the absence of a clear risk level, recommendations are based on the precautionary principle. This does not exactly agree with the present research findings and does not justify categorical demands for total abstinence during pregnancy. There are only four RCTs of psychosocial or educational interventions for reducing alcohol intake in pregnancy. Outcomes were heterogeneous and the effects were mostly not significant. Meta-analysis was not feasible (Stade et al., 2009). Traffic and motor vehicle injuries. The performance of intoxicated persons is undoubtedly impaired, and legal limits of blood alcohol concentration (BAC) are a crude but feasible indicator of impaired performance. Levels above 0.5 g/L increase the risk of driving accidents. Levels lower than 0.5 g/L have been found to have no effect on crashes (Desapriya et al., 2007). For obvious reasons, randomized trials of legal blood alcohol limit laws are not feasible. Before and after and cross-regional studies have been carried out. Some have found significant decreases in traffic accidents (Desapriya and Iwase, 1998, Mann et al., 2001, Hingson et al., 2000), others no decrease (Desapriya et al., 2007) or even an increase (Bernhoft and Behrensdorff, 2003). A review concluded that where beneficial effects are observed they seem to be due to general deterrence, and not restricted only to drivers at blood alcohol concentrations affected by the legal change (Mann et al., 2001). The above studies are subject to several biases, such as changes in criminal activities, drug addiction, drunken comportment, moral attitudes, citizen activism, weather conditions and traffic density. When several types of actions to decrease drunken driving are introduced during the same period of time, it is impossible to isolate the impact of each of these actions. Such has been the situation in the USA, where the public’s attitude toward drink-driving was substantially transformed in the 1980s. Citizen activism, expressed through organizations such as Remove Intoxicated Drivers and Mothers Against , is usually credited for the change that stimulated the passage of key drunk-driving legislation (Fell and Voas, 2013). The actions included driving licence revocation upon arrest for driving while intoxicated, lowering the legal BAC limit for driving from 1.0 to 0.8 g/ L, raising the minimum to 21 years, zero-tolerance of any detectable BAC for drivers aged 20 or younger, and laws providing for vehicle immobilization confiscation for a driving while intoxicated conviction. The important thing is that the laws and their enforcement protect not only the drinker but also other citizens. The effectiveness of laws depends on law enforcement and penalties. This is a just case for paternalism, and applies to all motor vehicles except self-driving ones. Costs of treatment. If heavy, unrestrained drinking causes harm to others, the drinker might be held to be responsible for covering the related costs. This is not fair. First, in certain cases drinking is a way to self-medicate primary somatic, psychiatric or social problems, not the result of irresponsible drinking. This would decrease the need for treatment. Secondly, the causal effects are hard to prove at individual level. Solid evidence is needed but only available in a few, typically acute cases, if at all. It is not fair to demand that a chronic alcohol abuser should pay for the treatment of his or her liver disease or cancer, as long-term consequences of heavy drinking cannot be ascertained at individual level. Increased risk of disease and the number of cases attributable to heavy drinking can be estimated from studies of large population samples but not all harms among the heavy drinkers are due to heavy drinking. Diseases have multiple causes.

Discussion

Evidence on alcohol as a risk factor or cause for various disease and injury outcomes is based mainly on observational epidemiologic studies. A dose-response relation has been found between blood alcohol levels and several types of injuries, especially traffic crashes. Heavy alcohol use probably harms the unborn child, while light use is probably harmless. Insufficient epidemiologic evidence is available on the possible effects of heavy drinking on various negative behaviours, like bullying, verbal aggression and violence. Observational studies may, or may not, be biased because of less than optimal adjustment for both known confounders and residual confounding. Randomized controlled trials (RCTs) have shown that moderate alcohol use has beneficial effects on certain risk factors for some diseases. Findings on alcohol-related risks are the motivation for evaluating opportunities for prevention. It is commonly thought that strongest evidence comes from randomized controlled trials (RCTs). Brief interventions and marketing have been studied in such designs and no marked effects have been found. Moreover, wide scale screening of subjects for brief interventions would waste precious health care resources at the expense of treatment of patients. Lacking RCTs, evidence on restrictions, high taxation and legal BAC limits in traffic are based mostly on before-after and interrupted time-series studies. These designs have several drawbacks. Data series are often too short. Confounding has usually not been controlled, often because relevant data are lacking. In large data sets, even tiny differences can be statistically significant, even if they are not significant in practice. When several different population groups are studied within the same data set, as in before-after and time-series comparisons, multiple testing will produce some significant results just because of randomness. Nevertheless, such studies are often used to support stringent alcohol control policies, including restrictions and high taxation. A careful cross-sectional study has shown that stringent alcohol control policies do not show a relationship with alcohol-related diseases (Poikolainen, 2016). Totalitarian societies favour coercive paternalism. Libertarian societies try to keep paternalism in tight rein and give the citizens as much freedom as possible. Autonomy is a pivotal right to be cherished because it allows us to reach for the goals we value. We are free if we are masters of our goals and determine our own destiny, so as to be able to realise the best in us when we achieve our goals (Margalit, 2000). Isaiah Berlin believed that there are many goals whose pursuit enables us to realise the best in ourselves, and it is for us to choose among them (Berlin, 2000). He wrote: “Paternalism is a major enemy of freedom. It is ‘the greatest despotism imaginable’, according to Immanuel Kant. Paternalism is despotic, not because it is more oppressive than naked, brutal, unenlightened tyranny, but because it is an insult to man’s conception of himself as a human being, determined to make his own life in accordance with his own (not necessarily rational or benevolent) purposes, and, above all, entitled to be recognised as such by others”, Thus, the less paternalism, the more free the society. Having said this, I understand that a certain amount of paternalism is needed to keep a society organized and in peace. But that amount should be as little as possible. The more civilized the society the less it needs paternalism. The forms of paternalism should also be as gentle as possible. Nudging can be seen as gentle manipulation. One problem here is that manipulation is not a well understood concept. It is not clear what kinds of influence are manipulative and the conditions under which they are ethically acceptable (Dworkin, 2020). The same rules should apply to nudges as to the harsher forms of paternalism: it should be effective, fair and ethical. The soft and strong forms of paternalism in alcohol policies does not seem to meet these criteria. To sum up, the available evidence on effects and fairness weigh the scales against the alcohol control policies in general. There are but two exceptions: legal limits in driving motor vehicles and heavy drinking during pregnancy. Instead of globally uniform alcohol policies, countries should base their policies both to local cultural, historic and social circumstances as well as known facts.

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