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September 20, 2001-Lead paint rule could limit research in Md.

U.S. chemical companies, trying to gain strategic advantage in a lead-poisoning lawsuit by California municipalities, have made another attempt to punch a hole in the case by attacking one of its chief claims -- the contention that paints sold through the mid-1950s were a "public nuisance."

The president of the Johns Hopkins University, Dr. William R. Brody, says he is worried that a recent court decision limiting medical experiments on children in Maryland could drive tens of millions of dollars in research grants out of the state.

The Johns Hopkins University, Kennedy Krieger Institute, University of Maryland Medical System and Association of American Universities asked the state's highest court Monday to modify an Aug. 16 decision that criticized the ethics of a Kennedy Krieger lead paint study. The ruling by the Maryland Court of Appeals also prohibited any future medical experiments on children that pose "any risk" and do not directly benefit the children. "This decision could have enormously broad implications, because almost all studies involve risk," Brody said. "The polio vaccine could never have been developed with this court decision." Hopkins and the other institutions want the court to limit its decision so that it is no more restrictive than federal regulations on experimentation, which allow studies that pose a "minimal risk" to children if their parents consent. An attorney representing a family that sued Kennedy Krieger, a children's center affiliated with Johns Hopkins, said the universities are exaggerating the threat to future research. Saul Kerpelman, lawyer for Catina Higgins, said the court's decision will not stop important research, only irresponsible and needlessly risky research.

"The Kennedy Krieger study was unethical because they knowingly exposed children to poison to see how poisoned they would get, and they didn't warn the parents about the dangers involved, because they knew the parents would never agree to it," said Kerpelman. The court's decision last month means that Higgins, a mother from East Baltimore, and another parent, Viola Hughes, can move ahead with lawsuits against Kennedy Krieger in Baltimore Circuit Court.

The parents claim that their children suffered lead poisoning during a 1993-1995 study that examined 108 children living in homes with varying levels of partial lead abatement. Because researchers allowed children to live in homes with incomplete removal of old lead paint, the courts compared the experiment to the infamous Tuskegee Syphilis Study, which withheld medical treatment from poor black men so researchers could watch the progress of the disease. Dr. Gary Goldstein, president of Kennedy Krieger, said that the high court did not have all of the facts about the study when it issued its opinion, and that he's confident the judges will reverse their decision once they have all the facts.

Goldstein said that researchers and landlords removed all visible lead paint from all of the homes in the study, cleaned lead dust out of each house, and gave each child regular blood tests and checkups.

About 95 percent of homes in the poor Baltimore neighborhoods where the study subjects lived have lead paint in them. The cleanup by the researchers ensured that the families in the study had at least 80 percent less lead paint than the rest of the homes in the neighborhood, according to Kennedy Krieger's brief.

"When the facts are considered by the lower courts, that court will agree with us that the lead paint abatement study brought benefits to all participating children and their families (and) was properly planned and conducted," Goldstein said in a written statement. Dr. David Ramsay, president of the University of Maryland, Baltimore graduate schools, said that $19 million a year in grants that his professors receive for about 190 studies involving children could be put in jeopardy if the court's decision is interpreted narrowly.

"It's not just a matter of losing research dollars to other states. It would be depriving the children of this state cutting-edge treatments of life-threatening diseases, such as cancer. That's what really bothers me. It's the kids who ultimately suffer," said Ramsay.

Central to the concerns of both Maryland and Hopkins is how the courts interpret the prohibition on "any risk" in the Aug. 16 decision. University officials are concerned that this selection of wording could have "vast and presumably unanticipated consequences," forcing the termination of hundreds of important studies. If the term "any risk" is interpreted literally, Ramsay said he worries that studies into measles vaccines and HIV in pregnant mothers could be halted, among many other areas of research.

The court decision could also restrict research on adults who cannot make decisions for themselves, such as elderly patients who suffer from strokes, Alzheimer's disease and mental illnesses. Hopkins officials worry that 40 percent of their pediatrics research and much of their psychiatric and Alzheimer's research could be disrupted. Pediatricians at the Johns Hopkins Children's Center received $33.7 million this year to conduct 175 studies. The School of Medicine's division of psychiatry received about $28 million in federal grants to conduct 70 studies this year. Vera Sharav, president of the New York-based Alliance for Human Research Protection, said it's important that the court's decision remain in place.

"The court opinion is a powerful reaffirmation of the rights of children not to be exploited as laboratory animals," said Sharav.

Ruth Ann Norton, executive director of the Baltimore-based Coalition to End Childhood Lead Poisoning, said removing lead contamination in homes is an enormously complex issue.

As many as 8,000 children in the city may have elevated lead levels in their blood, meaning that their ability to learn in school and hold jobs later in life could be damaged, said Norton.

"Even after 50 years of research, it's an extremely difficult problem," said Norton. "But what has become increasingly clear is that we have to push harder for full abatement, because interim measures will not keep kids safe."

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