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| Image from Doctors Without Borders |
By David Concar
"When a deadly epidemic of bacterial meningitis swept through northern Nigeria in 1996, Samaila Musa's parents did the obvious thing. They took their stricken 7-year-old to the infectious disease hospital in the nearby city of Kano.
Amidst an anguished dispute over what happened next, one thing is clear: The world's richest pharmaceutical company enrolled Samaila, and hundreds of infected children like him, as test subjects in a now-notorious drug trial.
A team from Pfizer Inc. had learned of the outbreak on the internet and flown to Kano armed with a promising new antibiotic called Trovan (trovafloxacin). With meningitis rare in the West, it was a golden opportunity to put the drug through its paces, compare it to a rival company's approved treatment, and gather the data needed for a license to market the potentially lucrative drug.
Trovan, alas, was no miracle cure. Several (the exact number is disputed) of the sick children given the experimental drug died. Many more suffered lasting injuries from their infections. Samaila, now a teenager, was struck deaf and dumb.
Pfizer says that Trovan worked better than any other treatment administered in Kano. But lawyers representing outraged Nigerian families dispute that view and claim that the trial violated international agreements, including the Nuremberg Code. These international guidelines were drawn up in 1949 to protect human subjects from the kind of appalling experiments Nazi doctors performed on concentration camp inmates.
"The Kano patients didn't know they were being enrolled into a for-profit study. It is absolutely abhorrent that you can use sick children as guinea pigs without informed consent," says Elaine Kusel, the legal partner handling the case at Milberg Weiss in New York.
Pfizer spokesperson Kate Robins disagrees. "The study was conducted in accordance with standard international legislation on clinical trials and the verbal consent of family members of all treated patients," she wrote in a statement sent to Amnesty International Magazine.
Whoever triumphs in the lawsuit, the Trovan affair is just one of several cases from the past decade that have begun to expose the secretive, ethically fraught nature of the pharmaceutical business and the globalization of human experimentation.
Shoe and clothing companies were among the first to seek out the cheap labor, tax breaks, and looser regulations of developing countries in the recent wave of globalization. Pharmaceutical companies discovered that they, too, could save money and time by moving the costliest part of their business — clinical trials — overseas.
It's easy to see why. While pharmaceutical companies face complex regulations and wary patients in the West, the developing world is filled with patients whose only hope of treatment is enrollment in a clinical trial. Add improving infrastructure to the mix and the attraction gets stronger. Chile, Argentina, and Thailand, while poor, have aspiring doctors, hospitals, and health ministers eager for the prestige, money, and access to medicines and equipment that accompany major drugs trials.
The pharmaceutical industry denies using the developing world as the medical equivalent of a sweatshop. "No matter where clinical trials are held, they're held to the same ethical standards," says Mark Grayson of Washington-based Pharmaceutical Research and Manufacturers of America.
Grayson points out that Western-sponsored clinical trials often spur access to better treatments and help countries develop medical expertise and understanding. "A medicine must at some point be tested where a disease exists, and this is why Pfizer sent its doctors to Nigeria," adds Pfizer's Kate Robins in her statement. It is "simply not the case" that the pharmaceutical industry is "conducting more and more trials in less developed countries to avoid regulations."
But that's not the perception of some experts and human rights activists in poorer countries. "The companies don't want to apply the U.S. regulations because they are too tight," says Miguel Kottow Lang, an ethicist at the University of Chile in Santiago. "So they come here and say 'We will use your regulations, or the regulations we are going to teach you.' "
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The clinicians, public health advocates, and a myriad of groups in the healthcare industry who entangle themselves in the complex web of global health encounter ethical dilemmas when they commit to health promotion in the developing world. That being said, the image above from a press release on Doctors Without Borders’ website represents an illegal drug trial that occurred in Nigeria. The Amnesty International article “A Bitter Pill” explains that Pfizer, the most affluent pharmaceutical company worldwide, entered Nigeria in 1996 with a drug recently developed to cure bacterial meningitis, a deadly infectious disease. However, the drug remained untested and its side effects on humans unknown. Anxious to beat competing pharmaceutical companies with a rival drug, Pfizer neglected to include this caveat. A human rights catastrophe ensued as the untested drug led to physical deformity, loss of physiological functions, neurological defects, and even death.
The moneymaking intentions of Pfizer in this example seem irrefutable but statistics cited in “A Bitter Pill” point to an increasing number of situations in which companies take advantage of vulnerable populations. The article cites a 2000 report from U.S. Health and Human Services Department's Inspector General's Office about experimentation in the third world, “From 1990 to 1999, the number of foreign clinical scientists seeking FDA approval to market new drugs increased six fold…which raised concerns about "aggressive recruiting" of human subjects”.
Vincanne Adams in “Against Global Health?” acknowledges this shortfall in the global health system when she alludes to varying perspectives of each actor involved. Adams investigates “how the commitment to health- the singular goal of global health programs- often becomes the means by which such programs authorize subtle shifts between epistemological frames”, a phenomenon evidenced by the drug trial in Nigeria (Adams 41). Under the pretext of providing health services and resources to developing regions, actors in global health can reach their objective- whether that is developing a cheaper alternative drug like Pfizer or truly attempting to address health issues relevant to the community of interest; historically, the latter paved the way for ethnocentrism in regards to non-Western beliefs about medicine and perhaps, even set the precedent for the structural violence that meningitis-afflicted Nigerians experienced.
From the epistemological frame of science, the interconnectedness of polities under global health permits scientists and researchers to uncover the hidden secrets of pathogens and to develop treatment plans. Vulnerable populations receive this scientific probing in the hopes of health betterment and increased resources while Western providers get insight into their beliefs and cultures that sharply contrast the scientific method and medical knowledge. “…Traditional beliefs were not merely non-scientific in the colonial medical mind-set; they seemed to be “nonsense” as empirical explanations of medical facts”, Adams relates from her study of the scientific perspective on global health (Adams 43).
Are health care providers and scientists, specifically physicians, to be blamed for the disconnect between viewing the patient as a fellow human being versus a patient whose body, or machinery, needs repair? The vicious cycle of ethnocentrism and structural violence perpetuates when global health actors fail to consider not only the significance of cultural beliefs but also the interest of the individuals in the community. Focusing again on the physicians’ role, how does a perspective of the human body as a machine develop?
“Learning Medicine” by Byron and Mary-Jo Good provides ethnographies of a class of Harvard medical students. The authors follow them as they internally transform and their perspectives of “the dual discourse” and the body change (Good 91). In the initial interviews, first-year medical students express this discourse as the importance of being a competent health provider while leaving intact the humanistic demeanor that allows for empathy. A common critique, that Western physicians omit the “caring” component of healthcare, points back to the statistics listed earlier about increased medical experimentation in the developing world. If physicians forget the “language of relationships, of attitudes and emotions, and of innate qualities of persons” and reduce patients to a body in which scientific reactions merely occur, human beings may become commodities to entities like pharmaceutical companies (Good 93).
However, physicians do not collectively deserve the position of global health scapegoat. Products of a system that Western academicians designed, physicians labor for several years to essentially learn a new medical vocabulary “as large as most foreign languages” and then dissect, dissect, dissect (Good 97). After year two of medical school, Harvard students recalled that anatomy lab marked the beginning of an alternate reality when their perception of the body reconstructed to become “machinelike” and “a thing of compartments” (Good 96). This reduction of a human being to organs and appendages reminds me of the Nigerians who served as study subjects for the experimental drug.
Nigerians enrolled in Pfizer’s 1996 study experienced commodification in that they represented an abstract variable with no agency in an experiment that put their lives in danger. Global health interventions service many deprived populations but also open up the same communities to possible exploitation. While physicians and members of the healthcare field claim to promote global health, perspectives among them form along the way that can lead to structural violence and in effect, do more harm than good.
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