The Generic that is Right for You

Jeremy Greene’s Generic: The Unbranding of American Medicine fascinates because the very meaning of the key term  “generic” is so unstable. Every time the reader thinks they have a handle on its dimensions, another four open up. The main cluster that grabbed me involved the seemingly endless variability in what constitutes a copy of a pill. Beyond the so-called “same active ingredient” (let’s call it a molecule for the moment), Greene traces the ways that the “inactive” ingredients, the coating, the processing, and even the look and feel of the pill, all might matter for the pill’s effectiveness and for its side effects. He also details specific cases where each of these did matter, noting that most of the time they did not. But who can know for sure?

And there’s the rub. Who is supposed to know, and who gets to judge that what is claimed to be same is same enough? One of the lines running through Generic is the burden of proof. Furthermore, are copies that meet some current standard assumed to be good enough until proven otherwise? And then are they fully substitutable in all cases? Or is it up to the maker of the copy to prove that the pills behave the same in all relevant people – at the limit this means running another full-scale clinical trial.

Greene exquisitely demonstrates how burden of proof is not a technical decision but a thoroughly business concept that works socially and politically in the U.S. The profits and growth of industries – big brand Pharma, small and big Generics, as well as insurance companies, HMOs, pharmacy benefits managers, and drugstore chains – are shaped by the time, delays, and costs of proof. Bruno Latour once argued, “Give me a laboratory and I can raise the world.” Here we have: Make me use a lab and I will lose a market.

Greene provides us with an historical kaleidoscope of public relations campaigns by all of the above industries that historically repeatedly repositioned the fate of “generics”: their destiny as good (because they are “the same but cheaper”, the trademark phrase of Dr. Simi and Farmacias Similares in Mexico – a social and political powerhouse I have learned to admire from Cori Hayden’s work on generics in Latin America), or their destiny as evil (because copies are dangerous the way that fakes and pirates are dangerous – adding unnecessary risk to your life). How any of us thinks of generics is the product of these public relations.

But Greene complicates this provocative cultural-political semantic line with a clinical biological one: the main reason why the sameness of generics to brand medicine measured one way is often not the same measured clinically is that humans are so variable, as are their so-called diseases (categories that continue to be adjusted, split, and invented). What Greene cannot do in this book is what he covered so well in previous one (Prescribing by Numbers), is explore the difficulty in stabilizing any one mass illness condition with a drug indicated for it. The very attempt to design a clinical trial for a condition affecting millions means creating a broad indication and a drug that works in only 1 in 10, or even 1 in 500 sufferers (see also my Drugs for Life). Perhaps it is because the efficacy of the branded pills is so hard to just “see” (by doctor or patient or even the FDA), that the question of whether a generic is the same “hard to see” enters the economic field with such political semantic reverberations.

I would love to see Greene explore this question a bit further in a future publication: the relationship between prescribing by numbers and regulating generics by those numbers. Especially, I’m struck by the fact that so much data on specific symptom and illness patterns and treatment practices now exists – electronically – in all of our patient records, yet they are not being used by governments as the giant clinical trial that they are, to figure out what works, for whom, and at what costs. (If we have already been datamined, at least we could be taking less medicine with better health results!). Greene mentions the 1933 book 100 Million Guinea Pigs, written before electronic patient records were imagined. Now we can make this 200 million clinical trial a reality. I say let it be studied. This may be one solution to the tyranny of choice.

Joseph Dumit is Professor of Anthropology and Director of Science & Technology Studies, UC Davis.  He is most recently author of Drugs for Life: How Pharmaceutical Companies Define Our Health (Duke, 2012).