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LIVELY CAPITAL
BIOTECHNOLOGIES, ETHICS, AND GOVERNANCE IN GLOBAL MARKETS
DUKE UNIVERSITY PRESS
Copyright © 2012 Duke University Press
All right reserved.
ISBN: 978-0-8223-4820-7
Chapter One
JOSEPH DUMIT
PRESCRIPTION MAXIMIZATION AND THE ACCUMULATION OF SURPLUS HEALTH IN THE PHARMACEUTICAL INDUSTRY
The_BioMarx_Experiment
The late Roberto Goizueta transformed Coca-Cola in the early 1980s. He had an insight—a simple but stunningly powerful one that he shared with his senior executives. What, he asked almost casually, was the average per-capita daily consumption of fluids by the world's 4.4 billion people? The answer was: 64 ounces. And what, he asked, is the daily per-capita consumption of Coca-Cola? Answer: less than 2 ounces (Charan and Tichy 1998). "We remain resolutely focused on going after the other 62," Mr Goizueta said (Coca-Cola Company 1996, 6). However absurd Goizueta's redefinition of the Coca-Cola Company's market might seem, it has been taken as a key transformative insight throughout the business world, demonstrating that "every business is a growth business" (Charan and Tichy 1998, 435). And that "virtually infinite growth" is a matter of finding the right formulation for the virtual and then actualizing it. One pharmaceutical parallel to global human liquid consumption is illness risk and the capacity to take drugs to ward it off. The more I read about markets and talk with pharmaceutical marketers, the more it seems as if this unbelievable growth in therapeutic consumption to ward off the risk of illness is happening. In this chapter, I elaborate the logics within the pharmaceutical industry that naturalize such growth.
Over the last twenty years, many scholars in medical anthropology and allied fields, including myself, have studied pharmaceutical resistance—pill diversion, strategic noncompliance, complementary and alternative medicine, and organized antimedicalization movements—as positive, creative, agentive challenges to the U.S. health system. While such resistance is widespread, the scale of our analyses has been enveloped (though not eclipsed) by the more general, macro scale of continued growth of pharmaceutical prescriptions.
According to the data,1 which I have reviewed extensively with statisticians and economists, the average insured American purchases ten to thirteen different prescriptions per year. Over 10 percent of all Americans, and 50 percent of those over forty-five years of age, are buying cholesterol-lowering drugs, a number comparable to that for antihypertensives. The growth rate in users of chronic treatments has been and is conservatively projected to be over 10 percent per year, and the total number of pills taken grows 3 percent per year (Express Scripts 2007). Antidepressant use, despite negative publicity on suicidal side effects, is projected to increase 5 percent a year, and the rates of use remained steady in children even where such drugs were more or less banned. Stimulants, especially attention-deficit drugs, are growing 15 percent per year overall and 30 percent per year among those under nineteen years old. The scale of the market in prescription drugs is $500 billion per year. This does not include over-the-counter drugs, vitamins, nutraceuticals, alternative medicines, and so on. The challenge is to account for the sheer amount of drugs being consumed and the mechanisms of their continued growth.
The numbers arrest me, even if I don't know how to believe them. What has abducted my interest is the problem of accumulation—the state of biochemical accumulation in the bodies of Americans continues at a rate that seems unbelievable, absurd, and unsustainable. At the center of the prescription growth in the United States are clinical trials as the key modality for determining facts about health and treatment, and guidelines that use those trials to redefine illness as a threshold. In this manner, health is reframed in the way that Goizueta reframed the potential consumability of soft drinks as something that can be grown in a virtually unlimited manner.
"We want to recommend more aggressive treatment to people who are at very high risk," said Dr. James I. Cleeman, the coordinator of the group that issued the guidelines, the "National Cholesterol Education Program" of the National Heart, Lung and Blood Institute.
"And," he added, paraphrasing Shakespeare, "there are more of them out there than are dreamt of in your philosophy." (Kolata 2001, 1)
Cleeman's suggestion is that clinical-trial implications exceed not only what one thinks, but also one's very imagination. To imply a failure of imagination is to propose a need to reframe the problem. The people-at-risk (patients-in-waiting), he intimates, are not visible, even to themselves. If Americans want to be healthy in the future, they must necessarily trust clinical trials and treat the numbers that they propose. Cleeman is talking about guidelines, introduced in 2001, which lowered the recommended level of bad cholesterol, thus tripling the number of people defined as high risk. Within his declaration is an order of reality in which epistemology (where clinical trials redefine high risk) determines that people who fall into the newly identified category are now ontologically at high risk, and being at high risk, they should (as in need to, ethically, imperatively) be put on treatment. Even as Cleeman pronounced these words, though, new clinical trials were under way that three years later, in 2004, would take the undreamed of numbers of people he referred to in 2001 and triple them, to 200 million. And in 2006 the thresholds were lowered even further.
In a paragraph taken from an article in the Wall Street Journal published in 2004, the author emphasizes a set of population statistics that intensify an argument about the dangers of not listening to doctors and clinical-trial data: "Only a fraction of people with high cholesterol are on statins, despite a barrage of drug-company advertising backed up by guidance from public-health officials. About 11 million Americans currently take one of the statins, while some public-health experts say that at least 36 million should probably be on one. Globally, the discrepancy is even more dramatic: About 25 million are taking the pills while an estimated 200 million meet guidelines for treatment" (Winslow 2004, 1). The new target number, of 200 million people worldwide, represented one out of every thirty persons on the planet.
Universal screening programs and mass pharmaceutical regimes continue to regularly appear in the news, with the line between good use and abuse being increasingly hard to draw. The twenty-first century has already seen recommendations for mandatory cholesterol screening starting at age twenty for all Americans and for prescribing standard pharmaceutical treatments for the approximately 30 percent of the population expected to be at high risk when tested. Children are subject to screening for obesity and other risk factors for heart disease in similar ways. Each of these screens works by setting a number, a threshold, which, when crossed, triggers a diagnosis of risk or disease and a recommendation for treatment. Underlying the controversies surrounding mammograms, PSA prostate-cancer tests, and other screens is a concern as to whether, in light of evidence suggesting that lower thresholds might help more people, there could be any reason not to make the test more sensitive.
Looking at the growth rates and the projected rates of growth, I am confused. How does "our" pill-taking continue to grow? My conversations with colleagues, doctors, and economists invariably end with the interim conclusion that an ever-increasing prescription rate makes no sense. However, despite actively looking for projections that prescription rates will taper off in the future, I cannot find them. Instead, rates are predicted to grow 8–15 percent per year. While the number of prescriptions must surely, logically, stop growing at some point, it seems there are other logics at work.
Rereading Marx, I heard echoes of this pharmaceutical logic, where increases in productivity paradoxically create more work: "Hence, too, the economic paradox, that [machinery,] the most powerful instrument for shortening labour-time, becomes the most unfailing means for placing every moment of the labourer's time and that of his family, at the disposal of the capitalist for the purpose of expanding the value of his capital" (Marx 1976 [1867]). Could it be that health has become expandable? Doctors, government health officials, pharma marketers, all pronounce the most mystical, teleological sentences, as if they were channeling Marx about an infinite imperative for accumulation, substituting pharmaceuticals in the body for hours of labor: "We want to maximize the number of new prescriptions"; "We want to identify people at risk at the earliest possible point."
Marketers want to maximize the number of prescriptions in order to maximize profits. They see clinical trials as investments whose purpose is to increase sales of medicines: "Important clinical studies to conduct from a scientific or medical perspective are sometimes not important studies to conduct from a drug development perspective" (Spilker 1989, 372). Pharmaceutical researchers openly express their unhealthy predicament: "One of the significant problems for the Pharma industry is that of the 400 disease entities identified, only 40 are commercially attractive by today's requirements of return on investment" (Bartfai and Lees 2006, 14). They see patients as points of resistance: "Pharma's New Enemy: Clean Living" (title on cover of Forbes, 29 November 2004).
Just substitute a few words and these marketers and researchers could be quoting Capital. This is not surprising, for Marx was, after all, quoting the industrialists of his day. What has shifted are the terms: it is Illness as Value that is now being maximized, and the Health of Patients rather than their Labor that is being exploited. There is a parallel in form: perhaps marketers see unproductive health the ways capitalists saw unproductive labor. That is, marketers may see clinical trials as investments that increase the extent and intensity of prescriptions the way capitalists saw machinery as an investment that increased the extent and intensity of labor hours. The grammar and logic of capitalists that Marx studied in Capital, in other words, seem to be mirrored by strategies of pharmaceutical executives and marketers.
Step-by-step, the logic is impeccable. Everyone agrees with the basic points and the underlying framework: first, since medicine is so expensive, pharmaceutical companies are required to fund much of the research; second, as companies, they must of course be able to earn a return on these "investments." This framework is not scandalous. If the analogy holds, then it makes clear a strange dynamic: health as a growth field through treatments; surplus health growth via clinical trials. Mickey Smith, the author of a dozen classic works on pharmaceutical marketing, describes this indefinite resource of health as growth. "For as long as everyone is destined to die from some cause, a decline in one can only come at the expense of an increase in another. This is an inescapable truth, yet there seems to be some failure to recognize it. What society, and the pharmaceutical industry to some degree, is doing is making conscious or unconscious decisions about 'tolerable' causes of death" (Smith, Kolassa, Perkins, and Siecker 2002, 32).
Smith is pointing out that if health is defined as reducing risk, then health is an infinite phenomenon, since for every risk you reduce or eliminate, you still have a 100 percent risk of dying from something else. The limit to health research is not, then, a realizable healthy body, but a risk-free body, which instigates a virtually infinite process. There is always room for another study and another treatment, until patients can't take any more treatment due to side-effects, costs, or effort. To put this back in Coca-Cola terms, where Goizueta took the prospective soft-drink market from a measure of people's desires for Coke to the limit of their capacity to consume liquid, pharmaceutical companies have redefined health from a measure of symptom reduction to the limit of our body's capacity to consume treatments. How many drugs could we be mandated to take?
It looks therefore as if pharmaceutical companies have found a way to grow health through clinical trials, redefining health as treatment, in part by expropriating the means of diagnosing illness, through screening tests that tell us and the doctor that we need treatment. Consequently, the interests of the pharmaceutical industry lie not in reducing treatments, but in increasing them. No matter how obvious this might seem now, I didn't immediately see the connections, even when pharmaceutical researchers said it directly: "No one is thinking about the patients, just market share" (Bartfai and Lees 2006, 73).
The dilemma might be summarized this way: clinical trials are by and large conducted in order to test new treatments for healing a disease state or reducing the risk of future disease. Clinical trials designed to reduce the amount of medication people take and still save lives sounds like a win-win solution—the company will have a better, more targeted drug to sell, and people will get better faster—but in practice this kind of trial is remarkably rare, even counterintuitive. If successful, such a trial would remove a large number of people from a risk category, essentially assuring them that they had less risk than they had thought, and the drugs they had been taking for health would no longer be understood to provide such. As I have talked with doctors as part of my fieldwork, they, too, have registered a sense of how odd this dilemma is. Most trials are set up so that either they are successful and a new, more intensive treatment regimen is indicated, or they fail and the status quo prevails. Only the trials that backfire and find excessive side effects result in reduced treatment. Doctors are particularly struck by how easy it is to put people on medication because they meet guideline criteria and how difficult it is to get them off. There are often no studies conducted to determine when it would be better or safer to stop giving a medication to a patient, while at the same time there are very few studies of the long-term effectiveness or safety of those medications (Klein et al. 2002). Such studies do not interest drug companies, because, again, they could conceivably shrink the market for treatments. The general trend, therefore, is for the industry to conduct only trials that would grow the market by increasing the amount of medication in our collective lives, and the empirical data for U.S. pharmaceutical consumption bears this out.
run the_biomarx_experiment.prog in all [marx.works]: replace [Capital] with [biomedicine]
Marx's categorical analysis seeks to explain some of the apparent anomalies of modern social life as intrinsic aspects of its structuring social forms: the continued production of poverty in the midst of plenty, the apparently paradoxical effects of laborsaving and time- saving technology on the organization of labor and social time, and the degree to which social life is controlled by abstract and impersonal forces despite the growing potential ability of people to control their social and natural environment. MOISHE POSTONE, TIME, LABOR, AND SOCIAL DOMINATION
Rereading Capital, I found what I felt to be remarkable parallels between the pharmaceutical growth process and especially the chapters on machinery. Machinery both multiplied labor power and therefore seemed to be a reason to labor less, and yet in the industrial system, it had the paradoxical effect of increasing the amount of labor needed, in order to continue to produce surplus labor. Theoretically this was worth pursuing. Thus, in order to better understand the pharmaceutical industry and the logic and political economy of treatment maximization, I have conducted an experiment: I have attempted to channel Marx, twenty-first century Marx, using twenty-first century technology. Karl BioMarx is the author of a future automatic translation of Capital into Biomedicine. I use biomedicine as the general term because I think this analysis has relevance to the broad set of health industries that are science, statistical, information-based, and for-profit.
(Continues...)
Excerpted from LIVELY CAPITAL Copyright © 2012 by Duke University Press. Excerpted by permission of DUKE UNIVERSITY PRESS. All rights reserved. No part of this excerpt may be reproduced or reprinted without permission in writing from the publisher.
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