Groups target study limits

Medical institutions seek lawmakers' aid on child research

`Getting universal support'

Legislation an option if appeal is denied

September 30, 2001|By Tom Pelton | Tom Pelton,SUN STAFF

The Johns Hopkins University and the Kennedy Krieger Institute are lobbying top state lawmakers to win support for possible legislation that would negate a recent court decision restricting medical experiments on children.

The legislation would be necessary if the Maryland Court of Appeals turns down the institutions' request for the court to modify the sweeping prohibitions on pediatric research it imposed Aug. 16.

Using harsh language to criticize the ethics of a Kennedy Krieger lead paint study that may have left two children with lead poisoning, the court issued a ruling last month that barred future experiments that present "any risk" to children.

Top Kennedy Krieger and Hopkins officials have met with at least 18 legislators to express their concerns that the decision will harm medical research in Maryland, said Lainy Lebow-Sachs, senior vice president of external relations at Kennedy Krieger.

"We're talking to everybody, and we're getting universal support for Kennedy Krieger. The leaders of the state are outraged that this is happening to us," said Lebow-Sachs.

Kennedy Krieger, Hopkins and the University of Maryland Medical System asked the court last week to reconsider its ruling in the lead paint case, saying the restrictions imposed would cripple the pursuit of critical medical and public health research.

Hopkins and Krieger administrators warn that the court decision would not only bar the study of vaccines on children, but also research on mentally ill adults or people who lack the ability to consent to their own enrollment in studies, such as patients with Alzheimer's disease. The court's prohibitions could drive tens of millions of dollars in research grants out of state, according to Hopkins President William R. Brody.

The medical institutions want Maryland to follow the standard set by federal law, which allows research that poses minimal risks to children if their guardians give consent.

"I think it was overkill by the Maryland Court of Appeals," said Sen. Barbara A. Hoffman, a Democrat representing Baltimore and Baltimore County.

"I think that whoever wrote that opinion went so far that we really do think it would stifle all research on children, to the extent that it would hurt the health of children," said Hoffman, who said she had spoken to Brody and Dr. Gary Goldstein, president of Kennedy Krieger.

A lawyer representing one of the two children who may have suffered lead poisoning during the Kennedy Krieger study was unimpressed by the lobbying campaign.

"It's a public relations campaign by Kennedy Krieger to try to salvage their image," said Saul Kerpelman, an attorney for Myron Higgins.

The parents of Higgins and of Ericka Grimes contend that their children suffered lead poisoning during a 1993-1995 study of the effectiveness of partial lead abatement techniques in about 100 Baltimore rowhouses.

In a pair of lawsuits pending in Baltimore City Circuit Court, the plaintiffs contend that the researchers put children at risk, knowing that some would ingest toxic lead dust during a study of cheap alternatives to total abatement.

Kennedy Krieger officials have asserted that their institution has worked for more than 30 years to prevent lead poisoning and that it would not intentionally poison children.

Researchers said that during the study they worked with tenants and landlords to clean and partially renovate rowhouses to reduce lead dust by at least 80 percent. The improvements were made in a neighborhood where about 95 percent of the homes contain lead hazards.

"The real answer would be to build new houses," said Kennedy Krieger head Goldstein. "But if you're talking about $100,000 per house, that's very expensive. The question is, until you build the new houses, do you do anything to decrease the risk of lead poisoning?"

Kennedy Krieger has gained an unexpected ally in its campaign in the Public Justice Center.

The center, a Baltimore-based nonprofit organization that provides legal services for the poor, filed a brief in support of the plaintiffs last year. But after the Aug. 16 appellate decision, the center filed a second brief asking the court to modify its opinion.

Deborah Thompson Eisenberg, director of the appellate advocacy program at the center, said the court went further than her group wanted when it prohibited parents from consenting to children's participation in studies that pose any risk. "We don't think that parents should never consent to have their children in studies," she said. "There may be situations in which such consent would be appropriate."

State Del. Howard P. Rawlings of Baltimore said he and House Speaker Casper R. Taylor Jr. had discussed the matter and would be willing to sponsor legislation negating the court's restrictions on pediatric research.

"We think the courts went too far in their decision, and they did it without any expert testimony to back it up," said Rawlings.

Byron L. Warnken, a professor at the University of Baltimore School of Law, said that the Maryland Court of Appeals is "slightly more liberal and slightly more activist than most courts." He said the court is sometimes "creative" in addressing public policy questions.

Warnken added that it is both legal and fairly common for legislatures to pass laws that negate court decisions. The practice happens five to 10 times a year in Maryland, he said.

Warnken gave as an example a state law that imposed extra penalties on drug dealers who used guns. The court interpreted the law to mean that prosecutors had to prove that suspects carried a gun during a drug transaction. But the legislature passed another law saying that there only needed to be proof that a dealer had a weapon hidden somewhere, not necessarily on his or her person.

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