Aug. 24, 2001 (Washington) -- Already reeling from a government inquiry into a patient death during an experiment last June, Johns Hopkins Hospital now faces another federal probe. This one involves a study conducted in the early '90s on ways to reduce the hazards of lead-based paint in children's blood.
A judge has already compared the research to the infamous Nazi experiments that blatantly ignored the rights of participants.
The Office for Human Research Protections (OHRP), part of the U.S. Department of Health and Human Services, started to investigate last week. In July, all research at Johns Hopkins was put on hold for five days after a 24-year-old lab technician died in an unrelated asthma experiment. The institution is the largest recipient of federal research dollars for medical studies.
Lead poisoning is known to damage a child's mental development. The lead study included five test groups, consisting of 25 houses each. According to court documents, the research was aimed at reducing the lead hazard in the homes so that they would be safe. But the repairs would also be economical enough so that Baltimore's inner-city landlords would not abandon these low-cost units. The research was done over a two-year period.
In some units, according to court papers, cleanup crews purposefully did not remove all the lead dust left from the paint, in order to measure the effectiveness of the lead clean-up approaches.
The research, done by the Kennedy Kreiger Institute, a Johns Hopkins affiliate, ultimately became an object of a negligence lawsuit by two mothers claiming that they weren't informed the experiment might intentionally expose their children to a lead hazard in order for the experiment to succeed.
Last week, the Maryland Court of Appeals reversed a lower court decision dismissing the litigation with the appellate judge drawing comparisons to Nazi atrocities, as well as the infamous Tuskegee experiment in which African-Americans infected with syphilis were left untreated.
"It can be argued that the researchers intended that the children be the canaries in the mines but never clearly told the parents," wrote Judge Dale Cathell in his 90-page opinion. Cathell also scolded the university ethics board for being "willing to aid researchers in getting around federal regulations designed to protect children used as subjects."
While declining to respond to WebMD's calls, the Kennedy Kreiger Institute said in a statement it didn't injure those involved in the experiment. "The study provided for every child to live in an improved environment that they would have otherwise. In this improved environment, the risk of lead poisoning was reduced for each and every child," according to the statement.
Kennedy Kreiger specializes in helping children overcome problems associated with childhood lead poisoning. It's estimated that in Baltimore alone, more than 100,000 homes have lead paint. Some 4,000 Maryland children annually are identified as having high levels of lead in their blood.
The U.S. Environmental Protection Agency originally funded the lead cleanup research for $200,000 in hopes of finding cheaper ways of reducing lead in house dust. Yet the problem persists.
Nationally, it's believed that lead poisoning afflicts as many as 900,000 children, leaving them with learning disabilities and other mental problems. Experts say, however, that the situation could be corrected by making homes lead-safe. And that is a relatively inexpensive proposition, says Jerome Paulson, MD, associate professor of health care sciences and pediatrics at The George Washington University Medical Center.
"It's where public policy should go in the United States if we are ever going to end the problem of lead-poisoned kids," Paulson tells WebMD. "If we continue to just screen kids, and therefore identify them once they have become poisoned, then we're never really going to get rid of this problem."