Criminal Record
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Understanding the Opioid Crisis
State–corporate crime theorists contend that serious harm frequently arises where the economic ambitions of corporations intersect with governmental priorities, particularly when public policies, regulatory decisions, and enforcement practices—whether by design or neglect—align with corporate strategies (Kramer and Michalowski, 1990; Tombs and Whyte, 2015).
This conceptual framework proves especially illuminating when applied to the opioid epidemic. Here, the pharmaceutical industry's pursuit of market growth converged with governmental choices that fostered a permissive regulatory environment. These included the approval and labeling of extended-release opioids, reimbursement systems that incentivized liberal prescribing, and a broader public health narrative that framed pain as a “fifth vital sign,” legitimizing prolonged opioid use (Van Zee, 2009).
Further exacerbating this crisis were lax oversight, the aforementioned “revolving door” between regulators and industry, and enforcement mechanisms driven more by financial settlements than by deterrence. These factors effectively normalized harmful practices by converting potentially criminal actions into mere operational costs (Tombs and Whyte, 2015). Within this context, the devastating consequences of opioid overprescription are not anomalies, but rather foreseeable outcomes of a systemic entanglement between corporate objectives and state regulatory systems.
Analyzed through this lens, specific corporate behaviors—such as the misbranding of products, aggressive marketing strategies, deployment of influential “key opinion leaders,” suppression of risk information, and the failure of distributors to report suspicious orders—can be classified as corporate crimes enabled or overlooked by state mechanisms (Quinones, 2015; Van Zee, 2009).
The theory further distinguishes between two types of complicity: state-facilitated corporate crime, where regulatory failures enable harm, and state-initiated corporate crime, where government policy actively spurs harmful corporate behavior (Kramer and Michalowski, 1990). Both are evident in the opioid crisis. While permissive approvals and insufficient oversight represent facilitation, policy moves emphasizing pain relief and economic productivity illustrate initiation.
Legal responses to these harms—ranging from civil settlements and deferred prosecution agreements to eventual criminal pleas in high-profile cases—highlight a troubling trend: accountability is often negotiated rather than enforced. This perpetuates an imbalance between how corporate and individual offenders are treated (U.S. Department of Justice, 2020; Tombs and Whyte, 2015).
Ultimately, the social consequences—rising death rates, community destabilization, and deepening inequality—demonstrate the analytical value of state–corporate crime theory. It redirects the focus from individual culpability to the broader institutional landscape that systematically manufactured what have become known as the “deaths of despair” (Case and Deaton, 2020).
Reframing Pharmaceutical Harm: A Zymological Perspective
Zemiology redirects the analytical focus from strictly legal definitions of crime to the broader processes that generate and distribute social harm. This shift enables a more nuanced analysis of pharmaceutical corporations—one that moves beyond questions of criminal liability to consider the real-world consequences of practices that are “lawful but awful” (Hillyard and Tombs, 2004; Tombs and Whyte, 2015).
While traditional criminology often centres on illegal conduct and individual culpability, a zymological lens highlights how legal mechanisms—such as pricing strategies, patent evergreening, data secrecy, and market exclusivities—can nonetheless produce preventable suffering. These practices, though legally sanctioned, can lead to avoidable illness, death, and financial devastation when timely access to effective medicines is denied (’t Hoen, 2009; Pemberton, 2015).
Zemiology also expands the scope of analysis both temporally and spatially. Harms do not occur in isolation but accumulate across the pharmaceutical supply chain—from clinical trial sites to manufacturing plants—and extend across national borders. These harms disproportionately impact poorer populations, who often endure catastrophic healthcare costs and delayed treatment access (Pemberton, 2015; Shadlen, 2017).
In this way, zemiology reconceptualizes corporate pharmaceutical activity not merely as a regulatory issue but as a systemic engine of inequality and ill-health.
Methodologically, zemiology calls for a multi-faceted approach to harm assessment—one that integrates epidemiological data, economic indicators, and rights-based metrics. This allows researchers to capture outcomes that legal frameworks typically overlook (Dorling, 2010; Pemberton, 2015).
Examples include quantifying preventable deaths due to delayed access to generics, harms from suppressed or selectively reported clinical trial data, antimicrobial resistance linked to pharmaceutical waste, and the exploitation of labour in outsourced manufacturing (Braithwaite, 1984; Walters, 2013).
From a normative standpoint, zemiology reframes the policy question. Rather than asking whether corporations comply with existing rules, it asks whether the broader institutional structures—such as intellectual property regimes, pricing negotiations, and data governance—serve to prevent harm and promote public health.
This reorientation supports actionable reforms: mandating transparency in clinical trials, leveraging TRIPS flexibilities, developing delink age models for R&D financing, and investing in independent pharmacovigilance. These efforts are not to be judged merely by legal compliance, but by their capacity to reduce social harm (’t Hoen, 2009; Tombs and Whyte, 2015).
In essence, zemiology enhances both the explanatory depth and policy relevance of criminological inquiry by placing the prevention of avoidable suffering—not merely the identification of rule-breaking—at the heart of its analysis.
The Corporate Capture of Scientific Knowledge and Its Consequences
Corporate influence over medical research and clinical trials exerts a powerful and often distorting effect on the production of scientific knowledge. Pharmaceutical companies frequently fund the majority of research conducted on their own products, giving them significant control over study design, data ownership, and publication rights (Bekelman, Li and Gross, 2003; Light, 2010).
This control often manifests in biased trial methodologies—such as the strategic selection of comparators, dosing schemes, and outcome measures—that subtly predetermine favourable results. Additionally, corporate influence extends to publication practices, where ghost-writing, selective reporting, and the suppression of negative findings shape the scientific narrative to serve commercial ends (Lexchin, 2012; Sismondo, 2009).
The privatization of knowledge through intellectual property rights and data secrecy further obstructs independent verification, reinforcing asymmetries between corporate marketing claims and scientific transparency (Kapczynski, 2012).
As a result, what is often presented as an objective medical evidence base is in fact a curated knowledge environment—constructed to support market expansion, sustain monopolistic pricing, and safeguard corporate reputations.
These distortions cascade into public health policymaking and clinical practice. Regulatory bodies, heavily reliant on company-provided trial data, develop a structural dependency that can compromise the integrity of drug approval standards and post-market safety monitoring (Abraham, 2009; Davis and Abraham, 2013).
Clinical guidelines and treatment protocols are similarly shaped by published literature that disproportionately features positive outcomes. Meanwhile, professional medical associations, often recipients of substantial corporate funding, may issue recommendations that align more closely with sponsor interests than with unbiased clinical evidence (Light, 2010; Angell, 2005).
The result is a policy landscape that prioritizes pharmaceutical interventions—often prematurely or excessively—over non-drug or preventive approaches, with significant implications for how health priorities are set and how resources are allocated (Sismondo, 2009).
From the standpoint of critical criminology and semiology, this pervasive corporate influence constitutes a form of structural harm. It produces knowledge that legitimizes commercial strategies, conceals scientific uncertainty, and systematically steers health systems toward profit-driven solutions rather than toward public well-being (Tombs and Whyte, 2015).
Transnational Pharmaceutical Corporations and Structural Violence in the Global South
Transnational pharmaceutical corporations (TPCs) play a central role in perpetuating structural violence across the Global South. Their profit-driven strategies are embedded within global political and economic systems that systematically deny entire populations the fundamental conditions necessary for health and survival (Galtung, 1969; Farmer, 2004).
At the core of this harm are intellectual property regimes and market exclusivities—formalized through agreements like TRIPS and expanded via “TRIPS-plus” trade deals—which sustain prohibitively high drug prices, delay the entry of generic alternatives, and ration access to essential treatments. These mechanisms effectively transform otherwise curable illnesses into sources of preventable suffering and death (Sell, 2003; ’t Hoen, 2009; Shadlen, 2017).
This system is further entrenched by secrecy surrounding research and development (R&D) costs, actual drug prices, and clinical data. Such opacity undermines both national purchasing power and public accountability, deepening global health inequities (Kapczynski, 2012).
In these conditions, access to life-saving medicines becomes determined by purchasing power rather than medical need. For many, catastrophic healthcare costs drive families further into poverty, while breakthrough therapies often reach patients in low-income countries last—if ever. These are classic indicators of structural violence in health systems (Farmer, 2004; Benatar, 2005).
The harms produced by TPCs extend beyond pricing and intellectual property. The spatial distribution of research, manufacturing, and waste reveals how harm is offloaded to economically and politically vulnerable regions. Clinical trials are frequently outsourced to low- and middle-income countries, where weak regulatory frameworks, fragile ethics oversight, and widespread poverty are exploited. This raises serious concerns about informed consent, post-trial access to treatment, and the displacement of risk onto already burdened communities (Petryna, 2009; Seriola and Ravindran, 2015).
In pharmaceutical supply chains, environmental offshoring—particularly in antibiotic production—has resulted in the release of untreated industrial waste. This has fuelled antimicrobial resistance (AMR), a global health crisis that disproportionately affects the Global South (Walters, 2013; Laxminarayan et al., 2013; Review on AMR, 2016).
Meanwhile, exploitative labour practices in outsourced manufacturing further intensify the harm, and investor-state dispute settlement (ISDS) mechanisms threaten national efforts to regulate drug pricing or pollution in the public interest (Shadlen, 2017).
Viewed through a zymological lens, these are not isolated incidents or simple regulatory lapses. They are systematic, legally sanctioned mechanisms through which corporate power produces predictable, preventable suffering—what should be understood as structural violence on a global scale (Hillyard and Tombs, 2004; Tombs and Whyte, 2015).
Inequities Driven by Secrecy and Intellectual Property in Global Health
Corporate secrecy and intellectual property (IP) regimes intersect in ways that fundamentally structure global health inequalities. They do so by constraining the flow of pharmaceutical knowledge, delaying the introduction of generic alternatives, and concealing the real costs and pricing structures of medicines. Under the World Trade Organization’s TRIPS Agreement, patents and data exclusivity provisions establish legal monopolies over active pharmaceutical ingredients and regulatory test data. These monopolies embed high costs and restrict supply—effects that are especially severe in low- and middle-income countries (WTO, 1994; Sell, 2003; ’t Hoen, 2009).
These formal legal barriers are further compounded by informal practices of secrecy. Confidentiality around clinical trial data, non-disclosure clauses in drug procurement contracts, and the opaque nature of research and development (R&D) and manufacturing expenses collectively erode the bargaining power of healthcare payers and obscure public accountability (Kapczynski, 2012; WHO, 2018).
The cumulative effect is that scientific advancements are converted into high-cost, scarce commodities. This leads to stark inequalities in access to treatment, even for essential medicines, as poorer populations face either devastating healthcare expenses or outright exclusion from care (’t Hoen, 2009; WHO, 2018).
While legal tools exist to counterbalance these inequalities, they remain politically contentious. The Doha Declaration reaffirmed that TRIPS should be implemented in ways that support public health objectives, advocating for mechanisms such as compulsory licensing, parallel imports, and research exceptions akin to the Bolar provision (WTO, 2001; Abbott, 2005; Correa, 2007).
Country-level experiences underscore both the promise and the political friction surrounding these tools. For example, India’s landmark Section 3(d) ruling in Novartis AG v. Union of India effectively curtailed patent “evergreening,” and the country’s 2012 issuance of a compulsory license for sorafenib led to a drastic price reduction. However, such measures are increasingly undermined by “TRIPS-plus” provisions embedded in bilateral trade agreements and intensified diplomatic pressure, which discourage their widespread use (Basheer, 2013; Shadlen, 2017).
Structural secrecy also disrupts equitable drug procurement by hiding the true net prices and supply conditions, thus fragmenting the collective purchasing power of countries and exacerbating global disparities (WHO, 2018).
From the vantage point of critical criminology and zemiology, this confluence of secrecy and intellectual property transforms legally sanctioned exclusivity into a form of social harm. It suggests the urgent need for alternative innovation and access models—such as open science, patent pools, prize-based funding, and advance market commitments—that can decouple R&D incentives from monopoly pricing and promote equitable access to life-saving treatments (Kremer, 2001; ’t Hoen, 2009).
How Criminalizing Drug Users Masks Systemic Corporate Harm
The criminalization of people who use drugs (PWUD) places responsibility squarely on individuals and narrows the policy lens to visible, street-level deviance. In doing so, it obscures the broader corporate and regulatory mechanisms that generate widespread risk and harm (Reiman and Leighton, 2020; Hillyard and Tombs, 2004).
By framing drug-related issues primarily as matters for criminal justice—managed through policing, prosecution, and incarceration—governments construct a moral narrative that pathologizes the behaviors of marginalized users. This focus diverts attention from the less visible but far more consequential “suite crimes” committed by pharmaceutical corporations: from drug design and aggressive marketing to price manipulation and data suppression (Cohen, 1972; Seddon, 2010; Tombs and Whyte, 2015).
This punitive framework is perpetuated by media-driven drug panics and a governance model that legitimizes coercive state control over addressing structural inequalities (Reinarman, 2005; Wacquant, 2009).
Within such a regime, the opioid crisis is frequently mischaracterized as a problem caused by irresponsible users or rogue prescribers, rather than being recognized as the product of calculated corporate strategies—such as misbranding and the manipulation of medical influencers—made possible by permissive regulatory environments (Van Zee, 2009; Quinones, 2015).
The resulting injustice is stark: PWUD are saddled with criminal records, subjected to imprisonment, and stigmatized, while corporate actors avoid disruption to their business models by settling lawsuits without admitting guilt or changing harmful practices (Tombs and Whyte, 2015).
Zemiology—by focusing on harm rather than legal definitions—helps reveal how criminalization diverts attention away from the structural roots of suffering (Hillyard and Tombs, 2004). Evidence indicates that punitive drug policies do not reduce drug use or overdose deaths. Instead, they exacerbate harm by driving drug use underground and deterring individuals from seeking help (Global Commission on Drug Policy, 2011; Alexander, 2010).
Meanwhile, the harms produced by corporations—through misleading opioid marketing, suppression of adverse data, and delaying access to generics—are routinely dismissed as mere regulatory issues rather than crimes (Van Zee, 2009; Case and Deaton, 2020).
This imbalance is reinforced in public spending priorities. Governments invest heavily in law enforcement and incarceration while allocating comparatively little toward independent drug safety monitoring, transparency in clinical research, or community-based harm reduction programs (Fraser and Moore, 2011; Reiman and Leighton, 2020).
To truly address the roots of drug-related harm, drug policy must be reframed around principles of public health, human rights, and corporate accountability. This would involve decriminalizing drug possession, expanding harm-reduction initiatives, mandating transparency in clinical trial data, and utilizing TRIPS flexibilities to improve access to evidence-based treatments—aligning governance with the prevention of harm at its source (Global Commission on Drug Policy, 2011; Hillyard and Tombs, 2004).
Power, Control, and the Unequal Criminalization of Harm
Criminological theories of power and control offer a critical lens through which to examine the stark imbalance between the punitive treatment of street-level drug offenses and the leniency shown to pharmaceutical corporations implicated in large-scale harm.
Conflict theory and critical criminology argue that the law tends to reflect and serve the interests of powerful social groups. As a result, corporate actors are often insulated from accountability due to their economic power, political influence, and ability to frame their conduct as legitimate or technical rather than criminal (Quinney, 1977; Reiman and Leighton, 2020).
While individuals who use or sell drugs—often poor, racialized, or otherwise marginalized—are subjected to severe penalties through harsh sentencing laws, stop-and-search policing, and incarceration, pharmaceutical executives rarely face prison time for actions that result in mass public harm, such as deceptive opioid marketing or collusive price-fixing (Wacquant, 2009; Alexander, 2010).
Instead, corporate misconduct is typically recast as regulatory non-compliance. These infractions are resolved through civil fines or deferred prosecution agreements, mechanisms that transfer financial liability to shareholders while preserving the underlying corporate model (Tombs and Whyte, 2015).
This disparity reflects what scholars term the divide between “suite crime” and “street crime.” It is not merely a matter of legal categorization, but of structural power—determining which actions are criminalized, how they are punished, and whose suffering is deemed worthy of recognition.
Control theories, such as Michel Foucault’s concept of disciplinary power, further explain how state mechanisms enforce this asymmetry (Foucault, 1977). The coercive tools of the state—surveillance, mandatory drug testing, incarceration—are disproportionately applied to the poor. Meanwhile, corporations are governed through administrative negotiations and flexible regulatory frameworks that ensure profitability is preserved (Snider, 2000; Braithwaite, 1984).
This creates a bifurcated system of social control: one where the marginalized are subjected to punitive, stigmatizing legal regimes, while the powerful are managed through technocratic and often deferential processes.
Importantly, this imbalance is not incidental. It is a core feature of neoliberal governance, which intensifies downward punishment while shielding capital and corporate power from equivalent constraints (Wacquant, 2009; Tombs and Whyte, 2015).
By exposing how the harms produced by pharmaceutical corporations are normalized, while the behaviours of street-level drug users are criminalized, criminological theories of power and control call for a redefinition of accountability. Rather than measuring it through the lens of class status or market legitimacy, accountability should be grounded in the scale and severity of the harm caused.
