the specificity of Generic

It is a pleasure to have the opportunity to respond to four careful readings of Generic so soon after its publication, especially from four scholars whose work has been so instrumental in shaping the nascent field of pharmaceutical studies.  Part of my goal in writing Generic was to take a mundane, everyday object (who will ever win a Nobel prize for inventing a generic drug?) and use it to explore the many layers of political contest and social context required to produce the sciences of similarity, laws of substitution, and markets of equivalence which undergird modern biomedical practice.  It is deeply gratifying to see these questions engaged on so many different levels of scope and scale.

To research the history of generic drugs is to research a series of controversies which are not merely scientific, political, and economic but also moral.  As Anne Pollock and Nancy Campbell have captured so well in their comments, generic drugs are frequently glossed in popular discourse as instruments of vice or virtue but rarely as both.  I must confess that I began the research for this book with a sort of tacit preference for the virtuous “little pharma” over the more venal “Big Pharma.”  But in the process of researching the history of the generic market, what emerged (as Pollock so nicely puts it) was a realization not only of the possibility of immoral behavior on the part of certain generic manufacturers, but of the amoral status of the industry as a whole, neither more nor less likely to engage in graft or collusion than the multinational corporations they were so pluckily arrayed against.  The American generic drug industry was encouraged to grow as a private sector solution to a public health problem; the moral practices that have emerged at that intersection are highly ambiguous.

Campbell’s nostalgic reverie for the passing of an era of pharmaceutical branding illustrates another important insight: that the generic drug is a tool for understanding the value of the pharmaceutical brand.  It is tempting to see the brand name as a veneer of marketing plastered awkwardly over an underlying chemical which could be better known by its generic name. That inner, generic drug becomes the true drug: it possesses efficacy, safety, pharmacokinetics, pharmacodynamics, all the things one needs to practice medicine. By contrast, the superficial, brand name drug represents everything commercial about biomedicine: advertising budgets, market share, return on investment. The difference between brand and generic seems to recapitulate Marx’s distinction between use-value and exchange-value: if the brand-name symbolizes all that is wasteful in commodified, profit-driven healthcare, the generic drug represents medicine at its most useful, affordable, and accessible.  Except that it does not.  Generic drugs have exchange-values as well, it’s just that the nature of that exchange differs between brand-name and generic markets (and, even among different forms of generic drug markets).  The generic drug, like the branded drug that came before it, is not a timeless ideal but a dynamic and historically contingent object that emerged at the intersection of key economic and political fault lines in the business and practice of American medicine.

Dumit’s comments invite further exploration of this generic specificity.  More specifically, he asks what kinds of knowledge is involved in making specific claims about generic medicines, and how generic medicines could in turn be used to produce different kinds of knowledge about different kinds of people.  In the course of research for this book I found many kinds of arguments as to why ‘generic’ was a normative concept that applied to people as well as drugs, and could also be a site of distinction and resistance.  If generic drugs worked the same in most bodies, did that mean they worked the same in all bodies?  Or were some kinds of bodies more sensitive to brand-generic difference than others?  This question could be asked using a taxonomy of diseases (was the use of a generic beta-blocker during a heart attack more troublesome than in the treatment of high blood pressure?) or of life stages (did the difference in kidney function in geriatric populations raise new concerns for the generic equivalence of renally cleared medicines? What about pediatric formulations?) or by other markers of distinction, including gender, race, and ethnicity. Extending some of Pollock’s earlier work on the racialized meanings of generic thiazide diuretics, I found a number of historical alliances between brand-name pharmaceutical manufacturers and minority health groups, who pointed towards the emerging science of pharmacogenetics to argue that—as with other forms of health-related knowledge—sciences of similarity assumed a mainstream white human subject population, and nonwhite patients might have good reason to suspect that they would be more likely to receive substandard care with a cheaper generic drug.  These controversies persist today in the guise of pharmacogenomics research.

More recently, patient advocacy groups like the Epilepsy Foundation argue that similarities in brand-generic switching in populations might mask more important differences in small subpopulations of “generic-brittle” patients.  Transplant surgeons ask whether higher standards of similarity should be applied to generic immunosuppressants since the costs of losing a transplanted organ are so much higher than the costs of needing to retitrate blood pressure medication.  New subdisciplines of pharmacoepidemiology are beginning to study how experience with brand-name and generic drugs play out in real time. In the past decade, the FDA has commissioned a project to link electronic medical records from various public and private health plans into a networked “Sentinel Initiative” to monitor in real-time the safety of drug products.   As an exercise in big data and drug experience, the pilot version of this—known as “mini-Sentinel”—currently represents the lived pharmacological experience of nearly 180 million Americans, which comes pretty close to the 200 million person clinical trial that Dumit calls for.

I am glad that Dumit mentions Cori Hayden’s comparative ethnography on generic drugs in North and South America, as I had initially imagined my own research project (an exploration of the many different historical ontologies of the generic drug in the limited geography of the American healthcare system) in conversation with Hayden’s  (an exploration of the many different local ontologies of the generic drug in the limited time period of the early 21st century) as an example of how historical and ethnographic investigations can work in complement to situate the same (or similar) biomedical object in different dimensions of social context.  The potential to foment this line of inquiry is one of the strengths I see in Somatosphere more generally: a space for overlaying thick descriptions of science, medicine, and technology using both historical and ethnographic methods.

Yet as Ecks deftly points out in his comments, it is not that easy for historians and anthropologists to simply divvy up the synchronic and the diachronic, the local and the global.  It was impossible for me to even begin the story of generic drugs in the United States without also discussing controversies over generic drug naming at the World Health Organization in Geneva; conversely it was impossible for me to close without describing the recent globalization of the generic drug industry and the outsized role that “generic giants” like Ranbaxy and Teva now play in the export economies of countries like India and Israel.  What emerges in Generic, however, is not a global history of generics, but rather a history that tries to situate US practices in a broader world in which the flow of information and commodities is increasingly more complicated—and more important—to trace.

Ecks is right to caution against reading a diffusionist narrative in this generic history, and though our analysis of the impact of TRIPS may differ, I fully agree with him that there are many generic histories not told in this volume, and that these histories are not merely subsequent to some ur-generic-history that took place in the United States, but parallel.  Compared to many European countries (and Japan), the US was much earlier to rely on a private generic drug industry to help bring health care costs down—in part because countries like France, Germany, and the UK used the bargaining power of their single-payer health systems to negotiate cheaper prices for brand-name drugs.  But alternate histories of generic drugs emerge in places like Brazil, Sri Lanka, Pakistan, and Bangladesh, where generic drug policy supported the development of state-based public generic manufacturers in postwar (and postcolonial) decades—a very different kind of endeavor than the private generic formations in the US.  And yet it would also be wrong to think these parallel streams are insulated from one another. As Victor Manuel Garcia has recently described, several of the principal actors responsible for establishing the Colombian generic drug industry were influenced by the generic drug hearings held by Senator Estes Kefauver in 1960, yet generic drug policies in Colombia succeeded where many of Kefauver’s initiatives failed.   This is not diffusion, but something much more tangled: a complex circulation of concepts and commodities between North and South.  Garcia’s work on Colombian generic history was featured as part of a panel on at the 4S conference in Buenos Aires this past August highlighting the growing network of scholars working to tell histories of essential medicines across a wide range of pharmaceutical geographies. These histories of generic pharmaceuticals are multiple and rich in their specificities, and beg for a collective reckoning along questions of ethics, markets, economics, and justice. It is my hope that Generic, far from the final word on the subject, will later be read as early effort in this vibrant new area of pharmaceutical studies.

 

Jeremy A. Greene, M.D., Ph.D., is Associate Professor of Medicine and the History of Medicine, the Elizabeth Treide and A. McGehee Harvey Chair in the History of Medicine, at the Johns Hopkins University. He is the author of Prescribing by Numbers: Drugs and the Definition of Disease (Johns Hopkins, 2009) and (with Elizabeth Siegel Watkins) Prescribed: Writing, Filling, Using, and Abusing the Prescription in Modern America (Johns Hopkins, 2012).