How do public health experts handle research when they know they cannot offer subjects the best medical treatment possible — only "less than the best" solutions?
It poses serious ethical issues, especially when children are involved in the research, as a controversial Kennedy Krieger Institute study shows.
Just 20 years ago, most houses in East Baltimore contained lead paint that was known to be poisoning children at epidemic levels. Amid the crisis, researchers at the pediatric hospital sought cheap, effective abatement techniques because full-scale cleanup could cost $20,000 or more per house — more than many of the properties were worth.
But the study has triggered lawsuits from families who say they were not properly warned of the risks of moving into partially abated homes. It's also prompted wide debate among researchers over the ethics of involving children in studies.
David S. Wendler, head of the vulnerable populations unit in the National Institutes of Health's Department of Bioethics at the Clinical Center, says institutions must consider how studies are designed when it comes to "less than the best" therapies.
Some believe the studies can be ethical, he said. For example, children in developing countries who have no access to expensive bone marrow transplants to cure their leukemia could be enrolled in a study to test a less effective pill because the alternative is most likely death. And potentially, families with no access to lead-free homes could be enrolled in a study to test the effectiveness of partial abatement.
"When you do these less-than-the-best studies, they are complicated and raise ethical issues, and they are hard to get them right," he said. "You need a sufficient reason to do these studies; that they are valuable for the population and not making people worse off compared to … what would happen absent the trial."
David Rosner, a professor at Columbia University's Mailman School of Public Health, called the Kennedy Krieger work a "terrible study."
He added, "It's especially unfortunate that children were harmed. ... This was a failure of public health, that we felt it was more important to get good data than to do what was obviously right. That was to get lead off the walls and make sure these kids were protected."