The Mortality Effect: Counting the Dead in the Cancer Trial
In its attempt to recruit patients with late-stage and metastatic renal cancer for a new trial of an experimental cancer treatment, Oxford Biomedica took the standard form of asking and answering an array of imagined patient questions in its patient pamphlet. The trial was organized as a standard randomized control trial (RCT), in which one group of patients would receive the new treatment and the other group would be given the standard treatments. No one would know which group they were in until the end of the trial, at which time the survivors would be counted, the side effects measured, and a decision made about whether to take the drug to the next stage of testing.
Among the questions appears one that addresses the key issue patients must struggle with when considering signing up themselves, and their caretakers, for a trial that will take a great deal of time and energy at what will likely be the end of their lives. The pamphlet puts the question in this form: “What happens if I get placebo and TroVax® is then shown to work?” Although the five-year survival rate for metastatic renal cancer is less than 5 percent, the answer to the question is given as: “If the study shows TroVax® prolongs survival and you received the placebo, you will be given the opportunity to be treated with TroVax®, following regulatory approval.”1 As with the vast majority of such trials, the drug was found to be ineffective; the trial was canceled after nearly a third of the patients died.2 To say, then, that the answer given to this imaginary patient question foregrounded hope would drastically understate the politics of recruitment for trials of experimental treatments for late-stage cancer.
The pamphlet might, after all, have had the imaginary patient ask: “What if I were in the TroVax group and it were shown not to work, or to work but with impossibly brutal side effects? Would I be paid for my time, which would be expensive, since there isn’t much left?” But the gut-splitting effect of the question and answer as given lies in its elision of two simple but critical facts. First, a person with metastatic renal cancer has virtually no hope of surviving long enough for this drug to come to market. Nevertheless, the inevitable deaths serve a critical role in the trial. Second, the vast majority of cancer drug experiments do not prolong survival. While diminishing this fact may well underwrite a patient’s search for a miracle cure, the question and answer rely on a serious misrecognition and misrepresentation of the temporal scope of the trial in relation to its mortal subjects.
Together, these effects result in a sort of ghosting of the lives that move through these trials; deaths maintain an everywhere and nowhere quality, even as they hold the statistics and results of the trials in place. I refer to this ghosting as the “mortality effect,” which I will elucidate through an analysis of how these cancer deaths, removed from particulars of individuals, produce paradoxical subject positions for the vast range of players involved in cancer culture. Consider, for example, that the immortal and mystical survival prognoses given to individuals at diagnosis require deaths to predict lives; they rely on an impossible future thinking since, as I have explored elsewhere, an individual does not 70 percent die, he or she lives or dies. Here I examine the infinite time line and life-or-death binary of the mortality effect as structured by the firm logic of the randomized control trial. But my concern with tracing one of the many paradoxes of cancer culture also includes an argument about the science. The logics and paradoxes I trace cannot be dismissed as merely cultural, for they fundamentally affect, justify, and enable the actual chemicals that are pumped into peoples’ bodies.
This recruitment pamphlet offers insight into one of many ways that both patients and oncologists are invited to live in a space organized through both hope and progress as virtually inescapable, ubiquitous tropes. Venues as distinct as marches for a cure, fund-raisers for children’s camps, and clinical interactions between doctor and patient parry the concept of hope. As cancer scholars Mary-Jo DelVecchio Good, Ilana Löwy, Helen Valier, and Carsten Timmermans note, the RCT plays a critical role in such infrastructures, building on a cultural presumption of progress in cancer treatment and providing the basis for highly protocol-driven treatments for cancer.3 The RCT method offers a site in which the structures of hope and future orientation are produced, represented, and deployed through the wider culture of cancer and its treatments and therefore offers a critical site of the cultural production of cancer. My ethnographic, literary, and historical research bears out the further observation that not only participation in trials but the very form and phantasmic role of the trial centrally structure experiences and understandings of cancer not only through the production of statistics about risk and prognoses but also in the ways some people with cancer orient themselves toward possible participation in future trials, in the ways people research their own and others’ disease (through drug selection, for example), in advertisements for cancer drugs, and in doctor-patient interactions.
No doubt the ubiquitous requirements for hope serve the interests of obscuring both cancer’s profitability and scientific uncertainty. Such obfuscation takes place through insidious slippages with a series of consequences. A lecture given at the annual San Antonio Breast Cancer Symposium (SABCS) in 2007 strikingly captured the temporal fissure I take as central to my analysis. Introducing his research with a roundabout acknowledgment, verging on thanks, of the people who partake in such trials, Mitchell Dowsett declared, “1,050 people would have to relapse before we had data.”4 Neither Dowsett’s translation of lives into data, nor the third-person voice of the “would have to,” nor the transference of people’s lives into terms of ownership over data fully accounts for the startling effect of this remark. Rather, the temporal shiftiness creates a counterfactual disjuncture: one knows only after the data are in that 1,050 recurrences were suffered. Yet Dowsett’s phrasing implies advance knowledge of the 1,050 recurrences. A subject in the trial may have hoped to be in the nonrecurrence group, yet after the data were in, the subject would know which group he or she had been in. These central, structuring temporal paradoxes of cancer culture — its inevitability, its predictability, the possibility and impossibility of early detection, the mystery of relapse — form the counterfactual hopes and histories made so vivid in these different views on the trial.
Here I suspend questions of whether the trial methodology itself works, or whether it would work if there were better oversight, exactitude, or basic science. Rather, I analyze the RCT as an actual, material, present structure — as a representational form — in and through which people live and die, and in and through which people eke out an understanding about the disease, medicine, and mortality. In examining the centrality of RCTs as a primary material practice in which cancer patients are constituted as material and conceptual objects and subjects, I aim to better understand how cancer is lived and reproduced in the United States.5
Because futurity so centrally informs American understandings of cancer research, fund-raising, survivorship, and treatment, the argument I pose may seem both counterintuitive and in some way abhorrent. As I have witnessed many times in talks and academic reviews, hope as a charitable emotion, a life raft, or a habit is not given up easily. One dispenses with it personally, analytically, and politically at one’s peril, regardless of survivor status, not only because of its obvious attraction but because of the identity politics that so often adheres to efforts to speak and write about cancer.
So to be clear, I do not question the intent of oncologists. Oncologists, like other experts, practice their profession for various reasons, both complementary and contradictory and with greater or lesser skill, which I neither question nor affirm. Similarly, I remain agnostic on questions of hope, survival, and treatment. I point no fingers at researchers, at people choosing among a sparse set of treatments, or those raising money for more research, camps, awareness, or rides to the hospital. Many patients, caretakers, and doctors tell their stories sincerely and sympathetically, albeit with a great deal of anger, trust, frustration, resignation, and grief, and this affect and these emotions remain central to any possibility of understanding the cultural traumas of cancer and the high stakes in this mode of critique.6 I am not arguing that the personal and social costs of cancer research are too high (though they are), and I am not attempting to determine how such an assessment should be made. I am not arguing that people are dying from chemotherapy and not from cancer (though many do); indeed, the complication in determining cause through ideologies of natural cancer and scientific treatment protocols holds a critical spot in the story about the ethics and cultural constitution of the dying body. Finally, I am not arguing that the logic directing the trials is nonsensical or inefficacious or that they should be banned. I provide no alternative format for drug testing.
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I want to thank audiences at the University of California, San Francisco; the University of Michigan; and Harvard University, as well as Gail Hershatter, Sharon Kaufman, Jake Kosek, Michelle Murphy, Diane Nelson, Elizabeth Roberts, Elaine Scarry, Derek Simons, Sylvia Sokol, Miriam Ticktin, Fred Turner, Kate Zaloom, the editors and reviewers of Public Culture, and the many people who have discussed cancer with me from so many angles. This article is dedicated to the Oxidate Working Group.
- Patient Information Leaflet FINALver.1.0, TroVax Renal Immunotherapy Survival Trial TRIST™ (accessed August 12, 2007). My italics.
- Action to Cure Kidney Cancer, www.ackc.org/trovax (accessed June 16, 2009).
- Mary-Jo DelVecchio Good, “The Biotechnical Embrace,” Culture, Medicine and Psychiatry 25 (2001): 395–410; Ilana Löwy, Between Bench and Bedside: Science, Healing, and Interleukin-2 in a Cancer Ward (Cambridge, Mass.: Harvard University Press, 1996); Helen Valier and Carsten Timmermans, “Clinical Trials and the Reorganization of Medical Research in Post–Second World War Britain,” Medical History 52 (2008): 509. Cancer trials have often “delivered at best marginal benefits” with controversial endpoints and success difficult to assess. “Nevertheless, such controversy did not undermine the progress of the clinical trial as an increasingly essential feature of clinical bio-medical research” (Valier and Timmermans, “Clinical Trials,” 501–2). “One of the new technologies that changed the face of clinical research was the clinical trial. The meaning of clinical trials has changed significantly since the 1950s.... Arguably this is a consequence of repeated reports on hopes associated with new experimental treatments since the 1960s (especially for childhood cancers) and the rigorous promotion of the randomized controlled trial as the gold standard of modern clinical research” (509).
- Mitchell Dowsett, “William L. McGuire Memorial Lecture: Biomarking the Estrogen Dependence of Breast Cancer” (lecture presented at the San Antonio Breast Cancer Symposium [SABCS], San Antonio, Tex., December 14, 2007). The SABCS is the main forum in which breast cancer study results and interim research findings are presented each year.
- Cancer trials differ from most other disease and drug trials in that they are typically not outsourced, though they may take place at several medical centers.
- Lauren Berlant writes of obesity as a form of “slow death,” by which she means “the physical wearing out of a population and the deterioration of people in that population that is very nearly a defining condition of their experience and historical existence” (“Slow Death,” Critical Inquiry 33 : 756). Cancer, like obesity, may be thought of as a form of slow death in that it can be analyzed and understood as related to forms of violence distributed in arbitrary and not so arbitrary ways and as a by-product of systems that require consumers and exposures.