More MS news articles for Aug 2001

Safety Concerns About Medical Research Triggered by Johns Hopkins Study

http://www.reutershealth.com/archive/2001/08/27/professional/links/20010827ethc001.html

PHILADELPHIA (Reuters Health) Aug 27 - A federal probe of a lead paint study conducted at Johns Hopkins University has pushed the school to the forefront of a debate about the safety of research on humans, medical experts and attorneys say.

The US Department of Health and Human Services said last week that it was investigating Johns Hopkins, the leading recipient of federal research funds, after a Maryland court compared its study of lead-paint hazards with the infamous Tuskegee study that withheld treatment from black men infected with syphilis.

The probe by HHS's Office for Human Research Protection (OHRP) came a month after the government temporarily suspended Johns Hopkins research programs over the death of a research volunteer in an asthma study.

Now the school's Kennedy Krieger Institute, a champion of efforts to eliminate lead from US homes, faces a possible multimillion-dollar class-action suit by Baltimore parents who claim the Institute risked the health of their children to study the hazards of different lead-contaminated environments.

"Kennedy's been the main treatment center for kids with lead poisoning in Baltimore city. Up to the point of this case, they've been among the good guys," said attorney Saul Kerpelman on Friday. Kerpelman is filing the suit on the grounds that Kennedy Krieger failed to inform parents that their children were being put at risk.

Kennedy Krieger officials, angered by comparisons with Tuskegee, declined to comment on the government investigation.

The Kennedy Krieger study was designed to test lead levels in homes with five different hazard levels. Seventy-five lead-contaminated homes were subjected to three methods of lead abatement - minimal, mid-level and extensive. There were also two control homes - one in which lead had been eliminated and another in which it had never been present.

The study included more than 100 families from a section of Baltimore with large numbers of poor people and minorities.

"In the ideal situation, all of these homes would be torn down and rebuilt," Kennedy Krieger said in a statement Friday, noting that funds have never been available to replace the homes. The institute added that "the risk of lead poisoning was reduced for each and every child" in the study.

Medical ethics experts say problems faced by Johns Hopkins illustrate a flawed US medical research system in which the interests of test subjects can be lost in the race for research grants and successful test results.

"If this study design got through because they weren't monitoring it carefully, then that's a real indictment of the whole system," Arthur Kaplan, director of bioethics at the University of Pennsylvania, said on Friday.

"The entire system for protecting human subjects is broken. Informed consent doesn't work very well. Peer-review is a problem because you've got people reviewing their friends and their buddies," Kaplan said. "And the pressure to get grants is making for conflicts of interest all over the place."