Hopkins Arm Sued Over Lead-Paint Study
But eight blocks north of the institute, at 1906 E. Federal St., a 4-year-old child was recruited to live in a lead-plagued house as part of a Kennedy Krieger study, according to a lawsuit now before the Maryland Court of Special Appeals--and he was poisoned by living there. The boy, now 11, was one of more than 75 children who were exposed to lead paint in houses that had been partially renovated so that researchers for Kennedy Krieger and the U.S. Environmental Protection Agency (EPA) could test the effectiveness of low-cost methods of controlling lead hazards.
The lawsuit was dismissed in Baltimore City Circuit Court last year, as was a different suit on behalf of another lead-poisoned child. This past June--the same month a healthy subject died while participating in a study at Hopkins' Asthma and Allergy Center, putting the school's medical institutions, including Kennedy Krieger, under the ethical microscope--the Court of Special Appeals heard arguments on whether to overturn those judgments and send both cases to trial. Whatever the eventual decision, the research reports from the study describe an experiment that plaintiffs' attorneys say ventured into ethically questionable territory--territory the attorneys say the institute has not even acknowledged.
In 1993, Kennedy Krieger was awarded a contract by the EPA to conduct the lead-abatement study, a three-year project co-funded by the state. The study involved more than 100 privately owned, mostly rental properties scattered throughout Baltimore City and divided into five groups. Two sets of presumably lead-free homes--16 constructed after 1979 and 16 older structures that had undergone full conventional lead abatements--served as control groups. The other three groups, of roughly 25 houses each, received varying degrees of repainting and repair that focused on trouble spots where lead paint was exposed or where lead-laced dust typically accumulates, on window wells, stairways, and floors. The repairs were funded by state loans and done to Kennedy Krieger's specifications.
All households in the study were required to include infants or toddlers young enough to be susceptible to lead poisoning. Half the experimental houses--including the ones that received the fewest repairs--already had families with small children living in them; the rest, including 1906 E. Federal St., were vacant, and researchers asked landlords to recruit appropriate occupants. At the beginning of the study and at regular intervals afterward, researchers visited all the houses and collected dust samples, as well as specimens of the children's blood, and tested the lead levels in both.
But the institution's view of the work, as expressed in a June legal filing, is that researchers had no obligation "to protect the health of the occupants of the premises" and that "there was nothing about KKI's relationship with [the occupants] that the law would impose such a duty." Or, as Kennedy Krieger lawyer Susan Boyce stated in a July 26, 2000, Circuit Court hearing, "The study that Kennedy Krieger was conducting was an environmental public-health research study. And it was primarily studying the properties. It wasn't studying any people, although minor children were participants in the study."
It's a line of reasoning Kenneth Strong, one of the lawyers suing Kennedy Krieger, calls "mind-boggling." He contends that his client, a 9-year old girl who lived in a fully abated study house at 1713 N. Monroe St., became poisoned while researchers took several months to notify her family that they'd found high levels of lead in the building. Strong says he expected Kennedy Krieger to question his assertions about how much lead was in the house and whether it was the source of the girl's poisoning, but "I never anticipated having to litigate the issue of whether [Kennedy Krieger] had an obligation to exercise reasonable care to protect the children in their study from being harmed."
The EPA, in its own published report on the study, supports the view that Kennedy Krieger was studying buildings, not children. In some sense, it was the houses that were sick, and it was the houses that were treated by full or partial abatement. The children were simply measuring devices, like the vacuum cleaners that picked up dust samples, to test how much lead was left in the buildings.
As such, the children had to meet certain standards. The study called for households that had "at least one child who was six months through 48 months of age at enrollment and was not mentally retarded or physically handicapped or had restricted movement." That is, the child had to engage in normal physical behavior--including a tendency to ingest household dust. Indeed, as the study reached the two-year mark, researchers noted that the interpretation of blood-lead data was complicated by the fact that the children had aged to "a range in which the frequency of mouthing behavior is likely to be less than in infants and young toddlers."
"It went one step too far," says Suzanne Shapiro, the lawyer suing Kennedy Krieger on behalf of the boy who lived on East Federal. "They weren't just observing the world as it existed."
The researchers did express some concern about exposing children to lead, in the abstract. "For ethical reasons," EPA's report explains, "the study did not include a non-intervention control group of houses that contained lead-based paint hazards." But the same reasoning apparently didn't apply to children in houses that contained partially treated lead risks.
Partial treatment was far better than none, argues Mark Farfel, a professor at the Hopkins School of Public Health. Farfel was one of the two main investigators in the study; the other was the late Dr. Julian Chisolm, a pioneer in lead-poisoning research. "We made the environment better in every one of those houses," Farfel says.
As Farfel notes and study data illustrate, most of the children involved had elevated levels of lead in their blood before the study began. "It is likely that the children in the [partially repaired] and previously abated houses had spent most or all of their lives prior to enrollment in low-income rental housing and thus were at risk of high exposure to lead in dust and paint due to poor housing conditions," the EPA report states. "[O]ne could hypothesize that, accounting for age, the [repair] interventions prevented increases in blood lead concentrations during the entire first year of follow-up that study children might have experienced otherwise."
Indeed, the average lead level of children in the study did go down. "The kids in this study [were] so much better off than the average kid in this city," Farfel says. "They benefited, and society benefited as well."
The institute's June brief says much the same, if a bit more portentously: "One can hardly imagine conduct that should be encouraged more than the work being done by KKI to improve the lives of infants and young children in Baltimore City."
But what's better for the average child--or better for the city, even--isn't necessarily good for the individual, attorneys Shapiro and Strong argue. And some of the children saw their lead levels rise, the lawyers contend, leading to cognitive damage. Tests on both children have found neurological deficits consistent with lead poisoning, the lawyers say; the girl from Monroe Street failed second grade and has been enrolled in special-education classes.
"I'm not quite sure," Shapiro says, "what the benefit of [the study] is to them."
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