Читать книгу Toxic Shock - Sharra L. Vostral - Страница 10

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Mystery

People get sick all the time. It is easy enough to minimize symptoms such as fever, chills, or sweats. Imagine then, that a person’s fever keeps rising, diarrhea and vomiting are unremittent, and fatigue and muscle weakness make it a Herculean effort to get out of bed. Deciding to seek professional, allopathic medical help carries an economic cost in the United States, so the decision to stay home and wait for the symptoms to subside is not unusual. In the late 1970s when a woman possessing these symptoms finally decided it was time to see her doctor, or a family member insisted she needed more immediate care at an emergency room, she would likely get an IV drip to replenish fluids and electrolytes, with further orders to rest at home. The sudden illness might take a turn for the worse, with her getting rushed into acute care and then suffering the onset of kidney failure. Still no one knew what was wrong. This all seemed very unusual for a healthy, young person, and it was likely that the attending physician would diagnose a severe viral infection.

Toxic shock syndrome (TSS) became this mystery illness in the late 1970s. What made it unique was that it challenged traditional forms of knowledge production about sickness. A direct causal model was insufficient to identify TSS. A paradigmatic shift to include a medical device as a cofactor was necessary for scientists and researchers to effectively associate tampons with TSS. Without a biocatalytic model as part of the usual scope of medical inquiry, recognizing this alternative pathway was not obvious. The politics of whether or not this should be “obvious” falls within the context of long-standing and systematic practices dismissing women’s reproductive health. However, with numbers on the rise, the life-and-death emergency-room cases could not so easily be ignored because the sufferers were mostly white teenagers and young mothers. This unknown malady needed to be framed in new ways, recognizing tampon technology in the illness process and challenging the long-held view that tampons were inert. It also required public health officials to argue for an unusual etiology, and one that manufacturers of tampons initially disputed.

This chapter examines how TSS gained traction as an illness and also how medical practitioners and epidemiologists further associated it with superabsorbent tampons. Within the milieu of the time period, it was neither intuitive nor “common sense” and took a good deal of research, contested at multiple levels, to conclude that TSS was a real illness with the potential of becoming an epidemiological event. In addition, the Centers for Disease Control (CDC) was under a good deal of pressure after some less-than-ideal outcomes with the 1976 swine flu pandemic that never arrived, and Legionnaires’ disease, which took nearly a year to analyze and identify. It could not afford to be the agency responsible for the deaths of thousands of young, mostly white, women, so it mobilized to thwart this emerging illness before it could unleash untold damage.

As researchers pondered what this set of symptoms might indicate, some possibilities emerged as potential culprits. Christian Schrock, an infectious disease specialist writing in the Journal of the American Medical Association (JAMA) in 1980 wondered whether it was a manifestation of herpes.1 Bruce Dan, an epidemiologist at the CDC, hypothesized it may be a variant of scarlet fever.2 Though it is the job of the epidemiologist to track outbreaks, both known and unknown, positively identifying an emergent and novel illness carries implications. Though sometimes medical-device technologies carry the risk of injury, postoperative infection, or even simply wearing out, they had not been assumed to catalyze illness in healthy individuals via bacteriological toxins. The very assumption of the safety of all tampons was called into question, which held both serious financial costs for corporations and also major adjustments to daily menstrual management practices for millions of women. How to identify an unknown syndrome, and the methodology used to do so, carried political consequences for federal agencies, corporate scientists, and women users, with ramifications still resonating today. In order to understand the scope of research and the marshaling of resources to contain the TSS outbreak in the late 1970s and early 1980s, it is useful to trace how this epidemiological event unfurled in the United States, looking at the relationship of state systems of public health with the national CDC, while acknowledging tensions not just between the public good and an individual’s health, but also between an individual’s health and corporate interests.

TSS: Background Facts

Though the exact numbers do not tell the story of TSS, from 1970 to 1980 the CDC counted 941 confirmed cases, 928 in women, and 905 at the onset of the menstrual period. The majority of women were white, but there were also seven black women, three Asian women, three Hispanic women, and two American Indian women.3 In total, seventy-three women died during that time period. A 1983 summary in the CDC’s Morbidity and Mortality Weekly Report (MMWR) outlined 2,204 cases of TSS, of which 96 percent were women, 90 percent occurred at the onset of menses, and 99 percent were tampon users.4 A bar graph entitled “Reported Cases of Toxic-Shock Syndrome, by Date of Onset” in the same report represented the rising numbers of cases, as well as the general decline, over the ten-year period from 1970 to 1980. Though there were many reasons for the decline of TSS in the latter half of 1980, ranging from better treatment to the successful message about risk associated with tampons, the correlation of the Rely tampon recall on September 22, 1980, with waning occurrences is hard to dismiss.

Figure 2.1. This bar graph regarding TSS represents the cases reported to the CDC, with 135 cases and 13 deaths in 1979, and 725 cases and 45 deaths in 1980. The number of reported cases reflected a steep rise leading up to 1980 and a sharp decline after Rely tampons were withdrawn from the market, according to CDC data. Source: U.S. Department of Health and Human Services, “Toxic Shock Syndrome—United States, 1970–1980,” Morbidity and Mortality Weekly Report 30.3 (January 30, 1981): 25–36.

Many have argued that thousands more were sickened but were not ill enough to have all the symptoms meeting the strict criteria of TSS (as defined in the introduction). Even those who likely died as a result of the toxin produced by Staphylococcus aureus did not always present all the symptoms associated with the clinical definition. There is not a mechanism to count these cases that fell outside what was reported to the CDC, and cases were collected with a “passive” system in which health providers contacted the CDC and not the other way around, so the numbers are presumably low. In comparison, 3,652 individuals died from influenza in the United States in 1980, for instance, and in the third week of January 1981, there were 21,125 reported civilian cases of gonorrhea.5 By now it is clear that HIV/AIDS is endemic to every stratum of society and was not contained at that time. In relative terms, the scope of TSS was far less than other communicable diseases, yet its legacy can be found on every tampon box purchased today.

The narrative constructed about TSS was critical to its reception as an illness worth fighting. In a 1981 report by Arthur Reingold from the CDC, he noted that 99 percent of the women studied were white, and 97 percent of 1,020 cases were women in middle-class families with incomes from $15,000 to $25,000.6 These young, white women were not constructed as derelict drug users; elderly, ill veterans; or irresponsible, gay men. They were future mothers and wives. No doubt the invisible hand of white privilege played a dominant role in constructing them as people worth saving. Additionally, an old trope of paternalism to rescue young women is evident as well. This is not to dismiss the good intentions of the researchers and agencies, or their ability to fulfill the mission of protecting public health. But, as a social practice, disease narratives carry meaning and consequences, and TSS initially benefited from its association with white women. However, TSS also suffered the stigma of being related to the disparaged female-specific bodily process of menstruation and the stigmatized tampon used to contain menstrual flow.

Identifying Illness

Recognizing, naming, and then treating a new disease is no small feat, and there should be a high bar for collectively agreeing that a set of symptoms and biological markers amount to an illness with social meaning. Recognizing the biological sense of disease is one thing, but socially responding to it is quite another. According to Charles Rosenberg, a historian of medicine, “it is fair to say that in our culture a disease does not exist as a social phenomenon until we agree that it does—until it is named.”7 Rosenberg identifies five major areas when “framing” a disease: (1) cognitive and disciplinary elements; (2) institutional and policy responses; (3) adjustments that individuals and families undertake; (4) relationships between doctors and patients; and (5) societal attitudes, values, and their rationalizations associated with the disease. In the case of TSS, these elements that frame disease are also at play. Medical experts identify a phenomenon of illness and name it; state and national health institutions weigh in to alert women; doctors, nurses, and healthcare providers must be educated to recognize symptoms; broader society reacts to the illness; patients incorporate the experience of illness into their personal identities. However, the unique elements in the framing of tampon-related TSS are both its association with technology and the biocatalytic quality of superabsorbent tampons. That is to say, the relationship of TSS to tampons muddied more traditional ways of identifying disease, raising difficult questions about causation, correlation, and association of technology with illness. It did not fit a typical pattern.

Furthermore, it is a bit inaccurate to call TSS a disease. It is neither communicable like the flu nor degenerative like arthritis. According to James Todd, the pediatrician who coined the name, a syndrome more accurately describes this illness. As he explained it, “A syndrome is a group of signs and symptoms and laboratory findings which seem to occur together and describe a single disease entity. But as it exists only that far, that is a syndrome.” The illness moves to the category of disease when researchers “know the cause of those signs and symptoms” with laboratory findings to corroborate the diagnosis. When clinicians “can prove this cause,” he affirmed, “then that’s a disease.”8 This distinction of a syndrome is quite important, because it is a way to acknowledge the unknown elements while still recognizing and legitimizing an illness with its associative social components.

Agreeing on the elements of an illness is one thing, but the social system to keep tabs on it, as well as to determine its threat to large segments of the population, is a different set of skills addressed by epidemiology. According to Mark Pendergrast, an independent scholar, “epidemiology is a science of probability, not proof.”9 This succinct description captures the inherent tensions about methods used by Epidemic Intelligence Service (EIS) officers at the CDC in determining normal disease patterns or novel, unusual, or increased incidents of illness. The goals of epidemiologists are different from basic research scientists. The outcomes of halting an outbreak or stemming the spread of a disease call on different methods and reliance on correlation, and optimally direct proof, as basis for policy.

In many ways, the identification of TSS followed similar patterns characteristic of other epidemics. Mark Dworkin, an epidemiologist by training, outlines fourteen steps of an outbreak investigation, though they may overlap or happen in a different order. The first step is to verify an outbreak by examining what is referred to as surveillance data. This, of course, assumes known infections rather than those illnesses of unknown origins. After analyzing the data, a diagnosis must be confirmed, which again relies on known tests and lab practices. Beyond this, more severe outbreaks require an investigative team with a leader to delegate tasks and set agendas for more complex situations, and even create a case definition. The team counts cases and conducts “epidemiologic analysis,” such as identifying variables, demographics, and patterns, for instance. This allows the team to develop a hypothesis about what may be going on and then determine control measures. Depending on the nature of the outbreak, more studies may be necessary, followed by analysis and additional control measures of individuals, treatments, or follow-up regimes. Epidemiologists use the language of “compliance” to describe how infected individuals, patients, or publics follow and conform to the recommended protocol. The last steps include communicating about the findings, establishing measures to prevent future outbreaks, and collecting surveillance data about the disease progression and its hopeful reduction through the outlined interventions.10 Though this provides a distinct process of how ideal organizational operations would unfold within the CDC or a state department of health when confronted with an outbreak, a theoretical epidemic does not always account for real-life unknowns, the messy work of detection, and its relationship to the social world.

Epidemiology is part science and part social detective work, and it is this component that is problematic to other fields of science, and under scrutiny in light of evidence-based medicine. Epidemiologists must gather pieces of evidence, which become factors, and judge whether or not correlation is significant to causation. Researchers readily rely on inklings, hunches, and past experiences, and they depend on both creative problem solving and stringent methods to identify known and unknown outbreaks. However effective this approach may be, its weakness lies in its inability to eliminate sufficient variables, or even provide significant proof. Lack of an occurrence can constitute evidence, which also becomes questionable methodologically in other scientific settings. Epidemiology is also reactive and thus does not have the luxury of long-term clinical studies to lean on for legitimacy.11

This is important because at issue is whether or not the recommendations set forth by the CDC should be believed. Steven Epstein, a sociologist of health and medicine, discusses how trustworthiness is at stake with methods and procedures, and he suggests “knowledge emerges out of credibility struggles.”12 Scientists’ claims must be believable in order to elicit support, shape arguments, and garner recognition. Yet the very thing that propels some of these research aims is characterized by differences in fastidious science and pragmatic science, as pointed out by Epstein, and defined by Alvan Feinstein, an authority on clinical trials at the Yale University School of Medicine.13 Fastidious science relies on “clean” data and “elegant” research designs, and it is likely carried out by academically trained researchers, promoting an ideology of purity leading to truth. This method seeks ways to reduce ambiguity and bias, and produce clear findings. By contrast, the pragmatic approach accepts messiness, ordinary variables in field and clinical settings, as well as occasionally ambiguous results. These differences are linked to power struggles between science-based academic researchers and clinic-based physicians, but the tensions are inherent to epidemiology as well. Epidemiology embodies this conflict, with both its need for scientific rigor and also its requirement to act quickly on behalf of the public good, in the messy theater of human life, when there is no time to wait for “clean” results from a well-designed study. It is here where politics and health collide.

New Diseases, New Difficulties