Drugs, risk and society: Government, governance or governmentality?

Abstract

This themed issue of Health, Risk & Society on Drugs, Risk and Society brings together six articles reflecting the importance of drugs in the study of health risks. The articles fall into three groups. The articles by Davis and Abraham (2011) and Gardner and Drew (2011) explore the government of risk and the ways in which regulators use scientific expertise to identify and control risks. Both articles show the limitations of such expertise and the influence of other processes. Davis and Abraham (2011) examine the ways in which political pressure on the US Federal and Drug Administration has made it more sympathetic to pharmaceutical companies. Gardner and Drew (2011) analyse the ways in which regulators in New Zealand were forced to respond to patient and media claims that a new formulation of Eltroxin caused side effects even though there was no scientific evidence for such claims. The second group of articles (Himmelstein et al. 2011, Jin et al. 2011) explore the governance of drugs and the ways in which governments seek to influence drug use through public health measures. This approach involves the sharing of the responsibility for the management of the potentially harmful effects of drugs with experts providing potential users with information on these effects and encouraging rational and the responsible use of drugs. Both articles show that this approach is likely to have limited effects if it does not address the underlying reasons for drug misuse, in the case of Chinese villages the pressure on local doctors to prescribe and sell antibiotics to their patients to maintain their incomes (Jin et al. 2011), or there is a lack of awareness or trust of the source of information, as is the case of parents in the UK and US buying over-the-counter cough and cold medicines for their young children (Himmelstein et al. 2011). If governments and their agents disregard individual understanding and perceptions they can be seen as using risk to construct social problems; those threatening the established order of society. The papers in the final section of this issue consider ways in which individual drug users resist such control and develop their own assessment of risk and their own patterns of drug use. Harrison and her colleagues (2011) consider the Australian government efforts to control the consumption of alcohol, in order to minimise its harmful effects and in particular to reduce young people's harmful ‘binge’ drinking habits. The participants in this study saw themselves as engaging in ‘controlled drunkenness’. These young people were interested in the pleasurable not the harmful aspects of alcohol consumption. In terms of the public health guidelines, most of these young people were binge drinking however they saw their drinking as reasonable and safe. McGovern and McGovern (2011) examine crack cocaine: an illegal ‘heavy-end’ drug which drug regulators consider causes considerable harm to its users and others and wish to prohibit. However for the crack cocaine users it was a purposeful activity. It enabled users to create meaning in otherwise meaningless lives. Crack cocaine enabled individuals to develop and demonstrate specialist and valued skills and knowledge and negotiate the dangerous ‘edge’ inherent in heavy-end crack cocaine use and control the uncontrollable.

Keywords:

• risk
• drugs
• government
• governance or governmentality

Introduction

This issue of Health, Risk & Society on Drugs, Risk and Society groups together a number of papers independently submitted to the journal. This themed issue reflects the importance of drugs in the study of health risks. This interest was evident in earlier volumes of the journal. In the special issue on globalisation (Volume 3.1) Yi-Mak and Harrison (2001) explored the ways in which eighteenth and nineteenth century imperialists deliberately encouraged the consumption of opium in China to balance Imperial trade and the ways in which such policies underpinned more recent patterns of consumptions of illicit drugs. This broad approach to the political and cultural contexts of drug use is unusual; most of the articles published in Health, Risk & Society on drugs and risk have focussed either on the ways in which governments try to regulate and manage the risks associated with drugs or on the ways in which individuals perceive the risks associated with drugs and how this influences patterns of use. The articles in this issue reflect and build on these themes: the first two articles explore the government of risk and the regulation of drug production; the second two articles explore the governance of drugs and the ways in which governments seek to share the responsibility for the management of the potentially harmful effects of drugs by sharing information about these effects and encouraging responsible use of drugs; and two papers in the final section explore governmentality and drugs and in particular the ways in which users resist and reject government attempts to shape their behaviour to ensure the safe and responsible use of drugs.

The government of drug risk: The nature of regulatory regimes and their response to evidence of the harmful effects of drugs

In late modern societies legal drugs are created and manufactured by ‘pharmaceutical companies … [who] have real commercial interests in making profits from the drug products they (seek to) market’ (Abraham 2002, p. 319) and are consumed by individuals who have ‘real health interests in both minimising the toxic risks and maximising the therapeutic efficacy of the drug products made available to them’ (Abraham 2002, p. 319). Given the asymmetry in access to information on risks and the ways in which drug side effects may have major impact on some individuals, it is very difficult for individuals to opt out of these risks. As Hood and his colleagues (1999) note, in such circumstances it is rational for the government to intervene in the market through regulation. Such regulation is usually designed to balance the benefits of supporting the development of profitable and innovative pharmaceutical companies with protecting the public from the potential harmful effects of consuming drugs.

The Thalidomide disaster of the late 1950s indicated the limitations of self-regulation by pharmaceutical companies, and governments in industrial democracies have taken on the responsibility for regulating pharmaceutical products; approving or licensing the use of new drugs and withdrawing or limiting the use of existing drugs as and when evidence emerges of particularly harmful side effects. Such regulation is usually delegated to an agency which uses technical and scientific expertise to assess the evidence derived from the trials undertaken by the pharmaceutical company seeking to market a new drug or, in the case of existing drugs, from post-approval surveillance. As Davis and Abraham (2011) note in their article in this issue, in the case of the United States of America this regulation is undertaken by the Food and Drug Administration, while in Europe drug regulation is undertaken by the European Medicines Evaluation Agency and its expert Committee for Proprietary Medicinal Produces.

The regulatory system is designed to maintain public trust in the safety of drugs by using independent scientific expertise to assess the benefits and hazards of drugs. However Davis and Abraham (2011) argue that there is evidence of ‘risk colonization’, particularly in the USA where ‘powerful industry interests have combined to produce permissive, rather than precautionary, risk management within pharmaceutical regulation’. This represents a major change as in the 1970s and 1980s regulation in individual European states such as the United Kingdom was ‘light touch’ while the FDA had a relatively confrontational relationship with pharmaceutical companies. Davis and Abraham (2011) argue that the FDA has been subject to political pressure especially from neo-liberals committed to minimising state intervention. In contrast in Europe the regulators are expert scientists seconded from individual nations who are insulated from political pressure and less vulnerable to pressure to minimise regulation.

Davis and Abraham (2011) show that in recent periods the US Food and Drug Administration avoided withdrawing approval for drugs when potentially fatal side effects emerged by ‘risk managing’: communicating information on these side effects to potential users of the drugs. As Osimani (2010) has pointed out communicating or sharing information about hazards with potential users of drugs is a major way of managing uncertainty enabling producers to transfer the responsibility for decision making and risk taking to the users. Davis and Abraham (2011) argue that the FDA approach was not successful as risk communication did not result in the safer use of the dugs involved, and the drugs involved had to be removed from the market.

Since the regulatory systems that Davis and Abraham (2011) are analysing are operating in large complex settings, they are unable to explore the minutiae of drug regulation and decision making. In contrast Gardner and Drew (2011) examine the case of Eltroxin, a medicine used to treat hypothyroidism, in New Zealand. In the relative small-scale and open context of New Zealand the underlying decision-making process comes into clearer focus and the process is influenced by claims making (see Alaszewski and Brown 2012) in which the regulators effectively disregarded expert evidence and opinion.

Gardner and Drew (2011) describe how in 2007 a new formulation of Eltroxin was introduced in New Zealand and within a year there were reports of non-fatal side effects such as joint and muscle pains, depression and visual disturbances. The government drug regulation agency, Medsafe, and the committee responsible for monitoring adverse drug effects, Medicines Adverse Reaction Committee, both investigated and found no evidence of a medical or physiological basis for the reported side effects. The drug manufactures and drug regulators argued that there should be no difference between the new and previous formulation of Eltroxin as the active ingredients were the same. However claims by patients suffering from hypothyroidism that the new formulation was causing unpleasant side effects and was therefore unsafe received wide-spread media coverage enabling patients both to share their experience and to report their side effects directly to the Centre for Adverse Reactions Monitoring. The issue was then taken up by politicians. In response to media coverage and politicians’ concerns, regulators in New Zealand decided to approve and make Goldshield, a drug manufactured in the UK, available to patients suffering from hypothyroidism in addition to Eltroxin.

These articles analyse the ways in which the expert rationally-oriented drug regulatory systems are structured by and influenced by their political and social contexts. In Davis and Abraham (2011), political pressure on drug regulators in the USA has resulted in regulation which is more sympathetic to drug company interests and a greater willingness to shift responsibility for managing serious drug side effects from producers to users through risk communication. In contrast in New Zealand the proximity of drug regulators to the drug users, the media and politicians has made them more receptive to claims that Eltroxin caused side effects and offer an alternative even where there was no scientific evidence to support the claim.

The governance of drug risks: Communicating and sharing risks

As we have argued in the previous section, governments in industrial democracies have taken on the responsibility for regulating pharmaceutical products, and these regulatory systems reflect their political and social contexts. In industrial democracies, systems of regulation have changed in line with changes in the structure and nature of governments. In the United Kingdom the cosy club culture of the mid-twentieth century with either light-touch or self-regulation with close relations between policy makers and producers has been replaced with more formal relations with structured regulation with some user representation (Moran 2003). This change can be seen as a shift from government to governance with elitist top down decision making being complemented by broader participatory processes. The shift to governance can be seen as part of the neo-liberal programme of shrinking ‘Big Government’ by enabling citizens to take over state activities. For example, in the Davis and Abraham (2011) analysis of the Food and Drug Administration, communication of the risks of serious side effects can be characterised as shifting some of the cost and responsibility of risk and risk management to citizens.

The shift to governance can also be seen as recognition of the limitations of government power and the ability of government to influence or control harmful activities or behaviours. This is particularly pertinent in relationship to drugs. While much drug use is beneficial, there are also uses which are collectively harmful which the government would like control. In the field of drugs the shift from a paternal relationship to one based more on partnership can be seen at individual or patient level in a shift of rhetoric from patient compliance with drug regimens to concordance (Bissell et al. 2004, p. 852).

The two articles in the second section of this issue examine two examples of such use and the factors which limit government impact on the potentially harmful use of drugs. The article by Jin et al. (2011) focuses on an area of drug misuse that causes considerable concern; the excess prescription and use of antibiotics contributing to the development of drug resistant diseases. They focused on four villages in China; examining the factors contributing to the misuse of antibiotics, for example their intravenous delivery to treat common colds.

Paradoxically Jin et al. found considerable concordance between the villagers and their doctors. The villagers, especially those coming from poorer families, felt they knew very little about drugs and relied completely on local doctors who they trusted to provide them with information about drugs and treat them. This trust was grounded in a number of factors; villagers had developed relationships with their local practitioners when they were barefoot doctors under the pre-market communist system, and had confidence in (expensive) western scientific medicine. Indeed their confidence in scientific medicine was so high that they expected it to develop new drugs to deal with diseases that have developed resistance to existing drugs. The villagers’ trust in their local doctors was to some extent misplaced. Following the market reforms of health care in China, ex-barefoot doctors could no longer rely on government funding and had to develop new sources of income; particularly selling expensive drugs to villagers. Unscrupulous ex-barefoot doctors (and other providers) abused villagers’ trust to over-prescribe antibiotics.

Himmelstein et al. (2011) consider the ways in which parents in the UK and USA respond to drug regulators’ concerns about the purchase and use of over-the-counter cough and cold medicines for young children. Both the USA's Food and Drug Administration and the UK's Medicines and Healthcare Products Regulatory Agency have issued guidelines discouraging parents from using such medicines with children under six years old. Himmelstein et al. (2011) found that despite the efforts of regulators to communicate their concerns about the risks of such drugs to young children the message was not getting through to parents and when it did get through most parents were unwilling to act on it. For example in the UK there was widespread media coverage of the MHRA recommendations but one third of the parents in Himmelstein and her colleagues’ sample were unaware of the MHRA's concerns about use of over-the-counter cough and cold medicines for young children. Furthermore half of the participants who did know about the MHRA concerns and the recommendation that they should not give such drugs to their children did not believe the drugs were potentially harmful or were not sure what to believe. These parents showed a lack of trust in the regulatory body. There was a similar lack of trust amongst American parents.

Himmelstein et al. (2011) argue that drug regulatory bodies in both the UK and USA need to build public trust and improve the communication of risk information. However there may be an intrinsic flaw in this approach to the management of drug risks. Governance can be seen as a more sophisticated way of managing the potentially harmful effects of drugs than the traditional government approach. The governance approach seeks to develop partnership through the communication of relevant information. However as the articles in the second section of this themed issue make clear, this approach will also fail if it is not grounded in realities of drug production, marketing and use. If the government agencies seek to impose their definitions of risk and prescribe how drugs should be safely used without regard to those of drug users then their intervention can be seen as a form of governmentality or social control.

Governmentality and drug risks: Resistance and rebellion

Governmentality can be seen as the construction and use of knowledge to manage behaviours that challenge the established order of society. It involves a ‘broad shift in forms of surveillance and control from those based upon direct, face-to-face relationships between experts and subjects to those based upon the abstract calculation of risk’ (Petersen 1997, pp. 189–204). The papers in the final section of this issue consider ways in which individual drug users resist such control and develop their own assessment of risk and their own patterns of drug use.

Harrison et al. (2011) consider the Australian government efforts to control the consumption of another drug, alcohol, in order to minimise its harmful effects and in particular to reduce young people's harmful ‘binge’ drinking habits. The National Health and Medical Research Council argued that binge drinking is likely to adversely affect the development of the brain before it is fully developed at 25 years. Governments do not consider that alcohol has a therapeutic or medicinal effect but in most countries adults can legally buy and consume alcohol, and its (moderate) consumption is generally considered to be pleasurable. Harrison et al. (2011) identify the public health strategy proposed by the Australian government in draft guidelines produced. These are based on the concordance model and provide information on the risks of drinking to persuade individuals to minimise harm to themselves and others through ‘low-risk’ drinking: a maximum of two standard drinks per day.

Harrison et al. (2011) argue that such strategies are limited and unlikely to achieve the desired effect. In particular they note that these strategies define young people in a particular way; ascribing particular rationality, choices and risks to young people. They argue that such strategies seek ‘to engineer in young people forms of personhood that are characterised by similar understandings of the risks they face, and choices that they should make, in relation to their uses and consumption of alcohol’. The young people in the study by Harrison et al. saw the risks they faced and the choices they made in relationship to the consumption of alcohol in a different way. In particular they saw the consumption of alcohol as pleasurable and socially desirable. The participants in this study saw themselves as engaging in ‘controlled drunkenness’. For all of the young people in the study, alcohol provided a sense of confidence. They used alcohol to improve their mood and sociability while maintaining self-control. In terms of the public health guidelines, most of these young people were binge drinking however they saw their drinking as reasonable and safe.

McGovern and McGovern (2011) examine use of crack cocaine; an illegal ‘heavy-end’ drug which drug regulators consider causes considerable harm and wish to prohibit. Public health experts tend to focus on the individual and collective harm of heavy-end drug use, treating it as an addiction and seek to provide the knowledge and treatment which users need to kick the habit. As Harrison et al. noted, in relationship to binge drinking, regulators do not consider the perceived benefits of drug taking such as the pleasure of drug taking or the sense of self which users can derive from drug taking.

In their article, McGovern and McGovern (2011) provide an alternative account of heavy-end drug use derived from the accounts by drug users of their crack cocaine use. They use Lyng's (1990) analysis of voluntary risk taking as edgework in which individuals experience excitement and develop their sense of themselves by challenging themselves through undertaking dangerous activities such as mountain climbing. Viewed from this perspective, using crack cocaine is a purposeful activity. It enabled users to create meaning in otherwise meaningless lives. Heavy-end crack cocaine use enabled individuals to develop and demonstrate specialist and valued skills and knowledge and negotiate the dangerous ‘edge’ inherent in heavy-end crack cocaine use and control the uncontrollable.

Final comment: Government, governance or governmentality?

The development and use of drugs is an important feature of late modern society. The development of science and technology has enabled legal and illegal producers to create and manufacture an extensive array of substances that affect the bodies and minds of individuals living in these societies. While most of the effects are highly beneficial, there are also harmful effects from the side effects of some drugs and the misuse of others. It seems reasonable that the government in these societies should seek to control the production, marketing and consumption of drugs so as to maximise their benefits and minimise the harm they can cause. Such regulation is presented as rational, being based on expert evaluation of scientific evidence about the benefits and risks of specific drugs. Actual analysis of regulatory decisions indicate that they are open to other influences: in the case of the US Food and Drug Administration, pressure from neoliberal politicians has made regulators more sensitive to the interests of pharmaceutical companies and more willing to transfer risk to users through risk communication; while in New Zealand, regulators were responsive to users claims that the new formulation of Eltroxin caused side effects although there was no scientific evidence to support these claims.

While governments seek to control the risks associated with the production of drugs through regulation, controlling consumption requires a more subtle approach and is generally done through public health measures: the communication of risks of using specific drugs and advice on safe use. The success of the public health approach depends on the effectiveness of the communication, the extent to which potential users trust the source of information and advice and the extent to which those targeting the advice understand the perceptions and motivations of those using the drugs. The articles in the second and third part of this issue indicate limitations in all three areas but particularly in tailoring information and advice to potential users’ perceptions and motivations. The assumption that users will accept that drug use can be harmful and will rationally wish to reduce the levels of harms to which they are exposed does not take into account the benefits that users perceive, for example the pleasures of binge drinking or of using crack cocaine.