From over-the-counter pain relievers to illegal recreational substances, engineered drugs have become ubiquitous and increasingly influential in the making of our personal and social lives. Yet, in recent years, the pharmaceutical industry has come under public scrutiny for a series of controversies – from the implosion of the blood-testing company Theranos, to the Daraprim and EpiPen pricing scandals – that left many outraged and dismayed by Big Pharma’s blatantly commercial and seemingly unethical practices. As the interests of shareholders and patients continue to diverge, we sat down with BISR faculty and medical anthropologist Danya Glabau to discuss the state of the pharmaceutical industry, a topic which will be at the center of her upcoming course on Drugs and Society.
How did the pharmaceutical industry come to be? When did the industrial production of drugs begin and how has it evolved over time?
There is a myth that the Euro-American pharmaceutical industry started out as a noble endeavor and has only recently fallen from grace into opportunism and suddenly unconscionably high burdens upon patients. That is simply not true. The problems we think we’ve diagnosed in modern medicine are, in fact, constitutive of the pharmaceutical industry from its origins.
What we think of as the modern pharmaceutical industry has at least two distinct genealogies in the United States and Western Europe, where my research and this class are focused. One antecedent is the coal-tar industry. Many large pharmaceutical companies like Bayer, Geigy, Ciba, and Sandoz (all founded in Germany) entered the medicine space accidentally starting in the 1880s. As coal production grew, companies were looking for ways to use mining byproducts like coal-tar. Methods for manipulating carbon-based chemicals – what we call organic chemistry – provided new ways to do that, in particular providing the means by which to produce new kinds of red dyes. It turned out that some of these dyes had medicinal properties as well. These new products were easier to control and scale than the biologically-derived medications like morphine and quinine that were also being marketed in the late 19th century by American companies like Squibb, Wyeth, and Smith, Kline, and French.
The second antecedent is the network of small-scale operations for so-called “ethical” and “patent” medicines. Ethical medicines were substances marketed to and compounded for the patient by doctors, while patent medicines were marketed directly to consumers as all-purpose serums. It is hard to pin down a date for the start of this part of the drug industry, since people have always been making and sharing substances purported to improve health. But certain products gained visibility in the United States in the 19th century when medical “sectarians” – doctors representing different approaches to medicine before any professional body had taken training and licensing under control – became identified with different classes of cures. In the US, these products were heavily marketed and completely unregulated until 1906, and only lightly overseen until a 1951 amendment to the 1938 Food, Drugs, and Cosmetics Act gave the Food and Drug Administration (FDA) the authority to decide which drugs could be sold to the public or offered by prescription only.
What are the main vectors of regulation of the pharmaceutical Industry? Who regulates and why? What kind of power is circulated through the act of regulation?
The brief history I just provided of the pharmaceutical industry has obviously been affected by governmental regulation. From the creation of the US Food and Drug Administration (FDA) in 1938, to the allowance of direct-to-consumer (DTC) advertising in 1997, to the push and pull starting with AIDS drugs research in the late 1980s and early 1990s between ensuring the safety of new medicines and providing access to all of those who would benefit from them in a timely fashion embodied in procedures like Breakthrough Designation (BTD) and the Fast Track development program, government regulation has shaped how people encounter, buy, and consume pharmaceuticals in the United States. These developments are well-documented in official sources, though piecing together the history and figuring out its effects takes time.
Social scientists like myself are also interested in the social regulation of drugs. For example, what kinds of social networks and informal economies facilitate the circulation of illegal drugs, or of legal drugs for illicit purposes? Which uses of drugs are considered morally appropriate, and how do social attitudes become encoded in legally enforceable regulations (think, for example, about the difference between hormonal birth control and “abortion pills”, or about the ethics of using muscle relaxants for back injuries versus their use to immobilize prisoners during executions). When does allowable use cross into unsanctioned use?
To understand the power effects of drugs, it is important to understand how power is exerted and experienced at the individual level, not only as it is officially encoded. For that reason, these social questions are more difficult to map through the official historical archive, and are often probed through questionnaires, reading archives of private documents like correspondence, in-depth interviews, or long-term ethnographic immersion in communities engaged in prescribing, using, exchanging, and regulating these medications. As the American public is increasingly aware, there is often a gap between the intention of regulation and its real-world exercise and effects.
Either kind of regulation is an exercise of power. With pharmaceuticals, the two tend to converge, making drugs and their effects on the body a particularly potent site of social, epistemological, and legal regulation.
Do legal and illegal drugs perform the same social function or do they behave differently? Does the legal status of a drug inflect the way it circulates power, shapes identities, and functions in the world?
To continue with the theme of regulation, there is a different kind of regulation going with these two categories of drugs. With legal drugs, the targets of oversight and bodily manipulation are people who are embedded in the mainstream medical system, and by extension in the formal economy. To get access to legal drugs legally means having the money to pay for them at a store that holds various licenses and permits, to live in a place with the infrastructure to physically reach your provider, to have the means (such as a car) to use that infrastructure, to have the language skills to hear, understand, and enact a licensed medical provider’s advice – and to have many of these activities and interactions recorded and shared with third parties, like insurers, prescribing database companies, and hospital management. With illicit drugs (which may be illegal or may be legal drugs used in an unintended way), users get access through unofficial channels, learn how to use them from their social contacts who lack formal training, may be using them at a place other than their government-recognized address, may barter or exchange cash received in an undocumented way to get them, and so on.
The effects of these parallel systems of exchange come into relief when a system is disrupted. The current wave of the “opioid epidemic” is a great example. Opioids, of course, have a long historical association with deviance and cultural otherness that very much predates the current moral panic. But the recent uptick in use has been attributed to the ongoing popularity of long-acting prescription opioids. When this licit supply is disrupted, users may then look for illicit sources, from non-licensed sellers (those we call drug dealers) to the medicine cabinets of their friends, families, and neighbors. Suddenly a pharmaceutical customer seen as legitimate by the medical profession and regulatory infrastructure is an illegal drug addict. This movement can be particularly disastrous for people of color, people who are poor, and people who are socially isolated – people who, individually and historically, have fewer financial or cultural resources (including white privilege) to draw on for support or leniency when their slippage from licit to illicit is detected.
Like opioids, prescription antidepressants cause physical and psychological withdrawal when the supply is interrupted, prompting everything from relapse to self-harm to deadly seizures. Yet these drugs are not thought of as addictive, dangerous substances in the same way as opioids, and in fact a large apparatus – both cultural and medical – exists to perpetuate their continued, consistent use. Significantly, these drugs exist in a different cultural space, with a shorter history tied to the rise of middle class family life in the United States and Great Britain. Their social meaning is linked to economic mobility, medical progress, whiteness, and the nuclear family, which has serious implications for how their chemical effects are distributed and regulated. These are the kinds of interpenetrations of law, history, and social life that we will dig into more in my upcoming class.
In a recent piece on the EpiPen scandal, you urged science and technology scholars to pay closer attention to the political economy of drugs and the financialization of the pharmaceutical industry. What is to be gained in doing so?
Within the pharmaceutical sector, there is a great deal of enthusiasm for growth by acquisition. In many ways, this resembles the way Silicon Valley works, with successful, small start-ups scaled quickly with small teams and then gobbled up by bigger companies. There is a surprisingly direct connection between this strategy in pharma and in tech, as some of the biggest early-stage tech investors also invest in medical companies, and even those that focus solely on medicine learn from their colleagues in tech via the various companies they work with throughout their career and several cross-industry networking groups. The big companies benefit because they can shop around for later-stage, less risky technologies to trim development costs and “acqui-hire” strong employees. Small companies benefit because the possibility of such acquisitions eases their access to the investment community, even if their ideas are unconventional.
But I think this raises important questions. What does it mean for the same investment and corporate governance strategies that have been successful for Google and Facebook to be imported into healthcare? There are different ethical constraints in medicine than in tech that are important to protect – patient privacy and some version of autonomy are, I think rightfully, paramount values in medicine that tech doesn’t contend with to the same degree. There are different marketing and sales channels: I think most people are unaware that the government is a huge funder of healthcare through Medicaid, Medicare, the military, and the Department of Veteran’s Affairs, and that we all bear the cost of high-priced medications through our taxes and the national debt (to say nothing of private health insurance). There are also different timelines, since drug development is vetted for safety through multiple layers of checks and balances, from the local clinic where a new medicine is tested or sold up to the national level via FDA guidelines, that govern how safe is “safe enough.” It takes a long time – again, I think rightfully, because it builds in opportunities to detect problems before many people are exposed to a new chemical or device – yet Wall Street-style investors can exert incredible pressure, backed by the necessary legal resources, to condense the process.
So these are some of the things to think about carefully as we mix Wall Street and the clinic in the global pharmaceutical industry. And these are some of the things that are operating in the background when we talk about the price of EpiPens, or the ethics of using antipsychotics to control elderly people in nursing homes, or the subjective effects of amphetamine use starting in elementary-aged children, or the legal ramifications of withdrawing care at the end of life. As new, “financialized” models for the success of new drugs more explicitly drives decisions on the back end, we may see our options changing at the point of care.
To learn more about the pharmaceutical industry, consider taking Danya’s upcoming course on the topic, Drugs and Society, which begins on October 19th at The Studio in Little Italy.