Lead Wars. Gerald Markowitz

some, the Johns Hopkins study was an attempt by dedicated researchers to address the discoveries about the effects of low-level lead exposure and determine the cost of reducing harm to children living in leaded environments. This was the view the Baltimore City Circuit Court took in granting KKI’s motion for summary judgment and dismissing the suit initially. But others, including the plaintiffs on appeal, clearly saw things in a different light. In reversing the lower court’s decision and ordering the lawsuits to proceed to trial, the Maryland Court of Appeals in 2001, quite aware that the subjects of the KKI study were African American children, saw the case through the lens of a long history of ethical and social debate over the use of vulnerable populations in human subjects research, as well as through the lens of the ongoing environmental justice movement that joined the civil rights and environmental movements of the previous three decades. Since the 1970s, and particularly following revelations about the Tuskegee experiments, in which an initial sample of 399 African American men with syphilis were “observed” over a forty-year period from the early 1930s through the early 1970s and to whom state-of-the-art treatments were denied, historians, ethicists, and others had explored instances where scientific research has crossed generally accepted ethical and social boundaries. They had detailed the evolution of standards for human subjects research, the importance of informed consent, and other ethical issues involved in nontherapeutic and sometimes harmful experimentation.

      The Baltimore study was organized in the wake of a dramatic rethinking of the use of human subjects in scientific experiments. During the preceding two decades researchers had become acutely aware of the ethical dilemmas presented by human subjects research, especially when it involved “vulnerable populations.” The legacy of Nuremberg, the revelations about the Tuskegee experiments, and publication in the late 1970s of the “Belmont Report,” the landmark federal report that expanded and codified the principles of ethical research with human subjects, all combined to cast doubt on the morality and ethical basis of the KKI research.⁵² But this framework may be too simple, incapable of acknowledging the complexity of the issues at hand.

      Two contending interpretations of the events in Baltimore indicate fissures in the public health community over the ethics and politics of the KKI study, echoing the debates over research on vulnerable populations that emerged in the 1970s, 1980s, and 1990s and the debates over what was feasible to accomplish in a conservative political environment. In one common interpretation, the KKI study was intrinsically unethical because the means of protecting children by complete abatement from lead poisoning were well known, and to knowingly subject children to lead by placing them in homes where only partial abatement had been performed put them needlessly at risk. In the main contending interpretation, research such as Farfel and Chisolm’s on incremental improvements that could lessen exposures was necessary and important because, in the context of the social realities of housing and income inequalities in America, complete abatement on a large scale was a utopian idea. As two subscribers to this general interpretation explained, “Powerfully appealing egalitarian principles cannot be regarded as a sufficiently compelling reason to totally shut down research that offers a realistic prospect of improving conditions [in this instance, complete abatement] or to what many might consider a minimally just standard of living. . . . We contend that it is the failure to conduct such research that causes the greater harm, because it limits health interventions to the status quo of those who can afford currently available options [complete abatement] and deprives disadvantaged populations of the benefits of imminent incremental improvements in their health conditions.”⁵³

      In this light, the history of the KKI research could be seen as a tragedy rather than a melodrama: a fight between two defensible conceptions of the public good rather than a fight between the forces of good and evil. Of course, this raises different questions: Are two defensible conceptions of the public good both ethically justifiable with respect to putting others knowingly in harm’s way? Could not valuable research be—and have been—done on levels of abatement without putting children in harm’s way, with a differently designed study? Lurking here, too, is another question that, as we will see, adds a further twist: was it justified to assume that partial and complete abatement could be conducted safely and effectively in the early 1990s?

      The decision of the Maryland Court of Appeals to let the case go forward unleashed a storm of controversy and argument, not just about the KKI study but more generally about the ethics of what was called “nontherapeutic research” on children. Until the Maryland court decision, discussion about the use of children as research subjects, according to bioethicist Lainie Friedman Ross, had been largely “pragmatic.” She notes that “unless research is done with children the advances of modern medicine cannot accrue to them or to future generations of children.”⁵⁴ Following the KKI decision, the questions became more complex as ethicists began weighing in.

      The first article laying out the issues raised by the court’s ruling was written by Robert Nelson, a professor of anesthesia and pediatrics at Philadelphia’s Children’s Hospital, and published in late 2001. Nelson addressed three basic considerations relating to the use of children as vulnerable populations in research: (1) whether or not “the interventions or procedures of the research offered the prospect of direct benefit to enrolled children”; (2) whether or not the “interventions or procedures involved in the research provided greater-than-minimal risk”; and (3) whether or not the parents of the children were properly informed of the potential risks of the study. On each of these issues Nelson argued that the court had acted properly in remanding the case to trial. With regard to the first question, for half of the children (those already living in housing that was to be abated as part of the study) the study “offered the prospect of direct benefit,” he said. But this was not true for those children who were moved into potentially more dangerous situations. Ethically, the partially abated home was a potential danger and therefore moving a child into it could not be considered a direct benefit. This was related to the second issue, whether the study presented these children with greater than minimal risk. Addressing this question was critical because the Belmont Report in 1977 argued, according to Nelson, “that a parent lacks the moral authority to expose a healthy child to more than minimal risk research.” Because the KKI researchers did not know for certain how partial lead abatement would affect the blood lead levels of the children, “the risk of continued lead exposure compared to the standard or full lead abatement procedure is more than minimal.” In addition, Nelson maintained, intentionally exposing children to lead by moving them into partially abated homes “cannot be considered as minimal risk” because “a ‘reasonable parent’ would not intentionally expose a child to environmental lead without making every effort to reduce or eliminate the lead exposure.”⁵⁵

      Were the parents properly informed about the critical matters that might concern a parent of a young child exposed to lead? The KKI study consent forms offered to the parents, Nelson said, “did not contain information that the ‘reasonable parent’ would want to know,” specifically, that the aim of the study was to evaluate “the effectiveness of three different methods of lead abatement,” what the impact on young children would be of the resulting lead exposure, and what the risks were “of inadequate lead abatement.”⁵⁶ Further, what action was reasonable to expect from public health and housing officials in this conservative political era?

      In the end, Nelson concluded, the court of appeals’s decision was consistent with the recommendations of the Belmont Report that “parents do not have the moral or legal authority to enroll healthy children in research that does not offer the prospect of direct benefit unless the risks of that research are no greater than the ordinary risks of daily life—a standard referred to as ‘minimal risks.’”⁵⁷ In short, healthy children should not be encouraged to move into potentially dangerous situations.

      Following the court’s decision, the critical issue that emerged for researchers, policy makers, and the public alike was the meaning of “minimal risk” and, more specifically, the relationship between socioeconomic inequality and the everyday risks of being poor in American society. The KKI study and the court’s response to it begged the question of whose life should be the standard of “the ordinary risks of daily life.” Did the dangers inherent in being poor mean, for example, that the children in the KKI study, because their everyday experience carried with it greater potential for harm, could