The Pharmaceutical Industry and the Definition of Norms

How diseases are defined in contemporary biomedicine? What kind of interests are involved in drawing the line between the normal and the pathological? Why pharmaceutical companies have become such crucial actors in today’s medical knowledge? Should profit-driven businesses play a role in determining health? These questions represent the starting point of Jeremy Green’s book Prescribing by Numbers: Drugs and the definition of disease published in 2007.

By looking at the American context from 1957 until 2000, this work focuses on the emergence of risk factors therapeutics in order to highlight the central relationship between drugs and diseases in contemporary medicine. The main point of the book is that the influence of the pharmaceutical industry now permeates the global economy of medical knowledge. While acknowledging the diversity of stakeholders, the author argues that pharmaceuticals have become central agents in establishing the boundaries between the normal and the pathological.

Greene develops this thesis using three case-studies. The first case narrates the interaction between the advent of hypertension as a worrying condition and the introduction of Diuril as a specific medication for asymptomatic high-blood pressure patients during the 1960s. This episode shows how hypertension became a substantial different disease after Diuril. By transforming antihypertensive treatment into a simple pill to swallow, Diuril lowered the threshold for the prescription of antihypertensive medications and enlarged the population of potential patients in both clinical trials and clinical practice (Greene, 2007, p. 54).

Such mutually defining relationship between the drug and disease is also the theme of the second case-study focused on diabetes and Orinase. Similar to Diuril, Orinase promoted a shift in the basic understanding of chronic conditions from a model of degeneration to a model of surveillance and early detection. The strategic marketing of oral medications such as Orinase, fueled a movement to make the screening and treatment of so-called «hidden diabetics» into a public health priority during the 1960s and 1980s (ibid., p. 134). Though never explicitly a disease, prediabetes came to be configured as a «borderline zone» determined by the logic of disease inclusion –and consequently– market expansion.

The third case-study examining the vicissitudes of cholesterol and Mevacor offers further concerns regarding the influence of pharmaceutical companies in today’s biomedicine. Regardless of the industrial shortcomings in proposing safe drugs (i.e. MER/29) and the theoretical doubts about the relevance of high-cholesterol as a disorder, the introduction of Mevacor in the 1980s transformed cholesterol into a worrying condition requiring screening, detection, and treatment. If knowing one’s cholesterol level eventually became an essential «act of self-surveillance», explains Greene, this is to be linked to the public-private effort to make awareness of blood cholesterol a priority for American physicians and consumers (ibid., p. 196).

«This argument was formally incorporated into the report of the National Institutes of Health Consensus Conference on Cholesterol and Atherosclerosis in 1985, a collective pronouncement of enthusiasts for cholesterol treatment that subtly but fundamentally redefined high blood cholesterol, at the same time announcing the creation of a federally funded program to fight it. The report of the Consensus Conference shifted the boundary between normal and abnormal in a step that retained normative statistical techniques while refusing
to acknowledge that the mean of the American population represented the state of health: “Often, an abnormally high level of a biologic substance is considered to be that level above which is found the upper 5% of the population (the 95th percentile). However, the use of this criterion in defining ‘normal’ values for blood cholesterol levels in the United States is unreasonable; because, in part at least, a large fraction of our population probably has too high a blood cholesterol level. A review of available data suggests that levels above 200 to 230 mg /dL are associated with an increased risk of developing premature coronary heart disease. It is staggering to realize that this represents about 50% of the adult population of the United States.” The Consensus Conference report detached the distribution of the normal population from the distribution of the American population and relocated the desirable mean leftward toward the distribution of an idealized “preindustrial” population. In this value-laden shift, the U.S. population was neatly transformed from arbiter of normality to locus of pathology. In place of a threshold defining the upper 2.5 percent as abnormal (300 mg /dL), the committee inserted a new threshold, 240 mg /dL, that intentionally defined the upper 25 percent of the adult population as abnormal, while labeling those with levels over 300 mg /dL as pathologically severe hypercholesterolemics» (Greene, 2007, p. 197).

Amidst the many interesting arguments presented in this book, a remarkable point to highlight is Greene’s idea of contemporary diseases as negotiated entities. In a sense, it can be said that one of the book’s major goals is to destroy –if there is still the need– an idealistic image of medicine as a value-free enterprise. According to the author, in fact, conceptual categories used by everyday physicians are not emanating from an independent éliteof experts taking decisions outside social forces. On the contrary, medical concepts such as diseases represent the product of a complex negotiation among many stakeholders including researchers, marketers, funding agencies, and public officials. The definition of health and illness, therefore, takes place within a delicate balance of interests where the fluid boundaries between normality and pathology are incessantly drawn and re-drawn.

While the book clearly addresses an audience interested in the history and social studies of Western biomedicine, some further connections can be advanced. In particular, Greene’s discussion of the «hidden diabetic» as a concerted therapeutic and marketing maneuver, might be linked to the consistent literature of critical mental health. Using historical, sociological, and philosophical methods, such a diverse group of scholars is concerned with various critical aspects of today’s mental health services including diagnostic expansion, stigma, and drug effectiveness, all topics relevant to Greene’s book (Bassett & Backer, 2015; Batstra & Francis, 2011; Beveridge, Oyebode & Ramsey, 2016; Gornall, 2013; Moncrieff, 2014; Rose, 2006; Starcevic, 2002).

Another possible connection can be drawn between Greene’s intensive focus on the issue of normality and a specific scholarship focused on such notion. In fact, Prescribing by Numbersoffers an important contribution to those historians and philosophers of science that have been dealing not only with the emergence of the normal/abnormal duality as a category of knowledge (Canguilhem, 1966; Foucault, 2003), but also with the production of norms and deviances over time (Crenner, 2014;Ernst, 2006; Igo, 2007; Lunbeck, 1994; Rose, 2009; Tiles, 1993).

«The recent history of elevated-cholesterol-as-disease uniquely demonstrates the fluid contemporary boundaries between physiology and pathology. Elevated cholesterol is a disorder of pure number, in which the diagnostic process is now as much a negotiation between the pharmaceutical industry and
guideline-setting committees as it is a negotiation between doctor and patient. Once the bodily perceived symptom is no longer necessary for the delineation of disease—once the number and the guideline themselves effectively become symptoms—the arbitration of normality floats free from the individual body into the broader logics of bureaucratic systems and the marketplace» (Greene, 2007, p. 219).

In conclusion, Greene’s book represents an authoritative account on the role of social forces in biomedicine and contemporary science at large. One question can be raised, however. Given the predominant influence of profit-driven companies in defining health and illness, what kind of subjectivity emerges from this negotiation? How are such procedures of perpetual screening and extensive therapeutics influencing our way of conceiving ourselves?

References

Greene, J. A. (2007). Prescribing by numbers: drugs and the definition of disease. Baltimore, ML: Johns Hopkins University Press.

Bassett, A. M., & Baker, C. (2015). Normal or Abnormal? ‘Normative Uncertainty’ in Psychiatric Practice. Journal of Medical Humanities, 36(2), 89–111

Batstra, L., & Frances, A. (2011). Holding the line against diagnostic inflation in psychiatry. Psychotherapy and Psychosomatics, 81(1), 5–10.

Beveridge, A., Oyebode, F., & Ramsay, R. (2016). Overdiagnosis in Psychiatry: How Modern Psychiatry Lost Its Way While Creating a Diagnosis for Almost All of Life’s Misfortunes. The British Journal of Psychiatry, 208(4), 400–400.

Canguilhem, G. (1966). Le normal et le pathologique. Paris: Éditions Gallimard.

Crenner, C. (2014). Race and Laboratory Norms The Critical Insights of Julian Herman (1891-1989). Isis, 105(3), 477–507.

Cryle, P., & Stephens, E. (2017). Normality: A critical Genealogy. Chicago, IL: University of Chicago Press.

Ernst, W. (Ed.). (2006). Histories of the normal and the abnormal: social and cultural histories of norms and normativity. London: Routledge.

Foucault, M. (2003). Abnormals: Lectures at the Collège de France (1974-1975). London: Verso.

Gornall, J. (2013). DSM-5: a fatal diagnosis? BMJ, 346(may22 21), f3256–f3256.

Igo, S. E. (2007). The Averaged American: Surveys, citizens, and the making of a mass public.Cambridge, MA: Harvard University Press.

Lunbeck, E. (1994). The Psychiatric Persuasion: Knowledge, Gender, and Power in Modern America. Princeton, NJ: Princeton University Press.

Moncrieff, J. (2014). The medicalisation of “ups and downs”: The marketing of the new bipolar disorder. Transcultural Psychiatry, 51(4), 581–598.

Rose, N. (2006). Disorders Without Borders? The Expanding Scope of Psychiatric Practice. BioSocieties, 1(4), 465–484.

Rose, N. (2009). Normality and pathology in biomedical age. Sociological Review, 57(Suppl), 66–83.

Starcevic, V. (2002). Opportunistic “rediscovery” of mental disorders by the pharmaceutical industry. Psychotherapy and Psychosomatics, 71(6), 123–145.

Tiles, M. (1993). The Normal and Pathological: The Concept of a Scientific Medicine. British Journal for the Philosophy of Science, 44(4), 729–742.

2 thoughts on “The Pharmaceutical Industry and the Definition of Norms”

  1. Thanks for sharing this with us, Filippo.

    BTW, Marga and I have known the Jeremy for many years as he and Marga were in Harvard’s history of science PhD program at the same time back in the early 2000s.

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    1. Hi Mark! Thanks a lot for reading this. I’m glad you’re receiving updates from my page 🙂 I really enjoyed this book and it’s great to hear that you guys know Jeremy Greene’s work too! I’m sure we’ll have the chance to talk more about this in your seminar. Cheers

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