Johns Hopkins under fire over children's exposure to lead
Mix it with water and the lead dust will go away, Martin remembers being told. Clean the windowsills. Clean the floors. Everything will be OK.
But it wasn't. Anquenette's lead levels got worse.
"I felt betrayed," said Martin, whose other daughter, 5-year-old Ashley Partlow, also lived in the row house. "I felt like my kids were used as guinea pigs."
There is now a pitched debate about the ethics of the mid-1990s Kennedy Krieger study that encouraged landlords to rent lead-contaminated homes to Martin's family and many of the 107 other poor Baltimore families with young children in the research project. The study, overseen by Johns Hopkins University, was denounced recently by Maryland's highest court. Baltimore judges had dismissed two lawsuits filed against Kennedy Krieger by mothers of children in the study. Now that those decisions have been reversed and trials have been ordered, the study's methods will finally get a public airing.
The Kennedy Krieger study also is being scrutinized by the federal agency that last month halted for five days federally funded research involving human subjects at Hopkins after the death of a healthy volunteer in an asthma experiment.
The single mothers who filed suit against Kennedy Krieger are Catina Higgins, Martin's roommate, and former West Baltimore resident Viola Hughes. Martin's attorneys also are preparing a suit.
The lead-paint study focused on the hardscrabble neighborhoods in West and East Baltimore, where Kennedy Krieger researchers estimate that 95 percent of the thousands of row houses built before World War II are contaminated by lead paint. The purpose of the study was to determine the minimum amount of lead cleanup that could be undertaken and still protect the health of children.
The researchers split their subjects into four groups of row houses, each receiving varying degrees of lead cleanup. Kennedy Krieger's lawyers, S. Allan Adelman and Michael I. Joseph of Rockville, Md., have said in court papers that the homes the children were to live in had to have elevated lead levels to be included.
A fifth group lived in modern homes with no lead paint.
Instructions to landlords
The researchers doled out grants for cleanup work in the contaminated homes to landlords, who were given instructions to rent the homes to families with small children.
The children could not be mentally disabled or have sickle-cell anemia. All of the children in the study were tested to measure the effectiveness of the different cleanup methods.
Hughes lived in a house that Kennedy Krieger's lawyers said had undergone a complete cleanup before she moved in, though her attorneys contend that test results showing high lead levels in the house were withheld from her. Higgins and Martin moved into a home that had been given a partial cleanup, which included established lead-removal techniques such as using sealants to make floors easier to clean and installing aluminum covers on door trims.
Kennedy Krieger officials say placement was a matter of chance. When houses in the study were available, landlords placed ads. Sometimes the houses had received major cleanup work, sometimes not.
Kennedy Krieger Chief Executive Gary W. Goldstein and Mark Farfel, the study's supervising researcher, have adamantly defended the research methods, though they have declined to talk in detail about the cases of the plaintiffs.
They say the three-year research effort took an innovative approach by identifying rental homes that might have been abandoned by landlords concerned about high cleanup costs.
Consent forms
Lawyers for Higgins, Martin and Hughes have argued that Kennedy Krieger did not do enough to warn their clients about the risks of the study, an accusation that was affirmed in Appeals Judge Dale Cathell's opinion.
The women signed consent forms that stated "lead poisoning in children is a problem in Baltimore," but the forms made no mention of specific health effects or of researchers' anticipation that children in the study would accumulate lead in their blood.
Kennedy Krieger's lawyers have argued that the institute did not have a legal obligation to warn the study's subjects about the risks, saying the consent forms signed by participants are not binding contracts.
Such positions, relying on technical interpretations of the law, have drawn the ire of groups that advocate reforms.
"There is a culture that has grown up among researchers; it puts science above human beings — and that's a very dangerous thing," said Vera Hassner Scharav, of the Alliance for Human Research Protection, a privately funded New York advocacy group.
When the Kennedy Krieger study started, the children of Higgins, Martin and Hughes all had lead levels below or slightly above the 10 microgram per deciliter safety standard set by the Centers for Disease Control and Prevention, according to the children's attorneys. But those levels rose quickly.
In seven months, the levels for Myron Higgins, now 11, went from six micrograms to 21, according to Suzanne C. Shapiro, who represents the Higgins family. The levels for Hughes' daughter, Ericka Grimes, went from 9 micrograms to 32, her attorney, Kenneth W. Strong, said; the levels for Martin's daughter Anquenette, whose name was recently changed to Charnice, went from 10.7 micrograms to 24, said Shapiro, who also represents the Martins. No test results are available for Martin's other daughter, Ashley.
Effects of lead levels
Lead levels of 20 or above have been shown in studies to lead to reduced IQs, while levels of 24 or above have been shown to increase the chances of mental retardation, according to the American Academy of Pediatrics.
Goldstein and Farfel say rising lead levels were not the norm in the study. They said researchers tracked declining lead levels for most children who registered above 15 on the contamination scale and that children with blood levels around 10 did not get worse.
Kennedy Krieger will not release the names of the study subjects, citing the confidentiality of medical records. The hospital's last contact with study subjects was about 1-1/2 years ago for routine follow-ups, Farfel said.
Goldstein and Farfel said no notifications are necessary and that the study already has improved the lives of most participants. They describe poor Baltimore neighborhoods as awash in lead hazards.
If the study subjects hadn't moved into homes linked to the Kennedy Krieger research, Goldstein said, they would have ended up in other contaminated homes, maybe ones that were receiving no treatments.
Asked whether he would change anything about the study, Goldstein thought for a moment, then said, "I don't think so."
Then, he paused again, adding, "That's not to say a mistake couldn't have been made."