News Media Home | Hopkins Medicine Home
September 17, 2001
MEDIA CONTACT: Joann Rodgers
PHONE: 410-955-6680
E-MAIL: jrodgers@jhmi.edu
MEDIA CONTACT: Gary Stephenson
PHONE: 410-955-6680
E-MAIL: gstephenson@jhmi.edu
In briefs filed today, The Kennedy Krieger Institute (KKI), Johns Hopkins University (JHU), the University of Maryland Medical System (UMMS) and other academic and medical organizations urged the Maryland Court of Appeals to reconsider or modify aspects of an August 16 ruling that revived lawsuits against Kennedy Krieger brought by two families who participated in a 1992 lead paint clean-up study.
The parties ask that the Court’s collateral ruling on the issue of parental and guardian consent for research on children and persons under legal disability be modified to realign Maryland law with rules that currently govern all federally sponsored and federally conducted research, and rules that are parallel with laws in the other 49 states.
If allowed to stand, the court’s August 16 ruling "would cripple pursuit of critical medical and public health research," according to the amicus, or friend of the court brief filed by JHU, the Association of American Medical Colleges (AAMC), the Association of American Universities (AAU) and UMMS.
Notably, the briefs from these parties do not ask the Court to reverse its decision on the lower court cases. Instead, they agree with the state’s highest court judges that these cases be sent back to the Circuit Court for trial to develop all of the facts regarding the lead paint study, which was approved by a Hopkins Institutional Review Board.
Gary Goldstein, M.D., president of KKI, said the Institute is "fully confident that when the facts are considered by the lower court, that court will agree with us that the lead paint abatement study, conducted beginning in 1992, brought benefits to all participating children and their families, was properly planned and conducted, that homes in the study all had lead clean-up, and families were promptly informed of blood test results." The lawsuits on behalf of two children in the study were dismissed by the Circuit Court without trial and were then appealed to the Court of Appeals.
"There has been much misunderstanding, misinformation and distortion surrounding this study, which was designed to confirm what experts have long known about how to prevent lead poisoning among inner city children and to demonstrate how well various methods of lead abatement work," said Goldstein.
"What is critical to know is that all of the methods worked and we knew that at the start. The study’s goal was to see how well each worked to actually reduce lead exposure and protect children. Every child who participated in this project was given regular blood tests and checkups. Every home visit was accompanied by clean-up and education. Visible lead paint was removed in every house," he said.
The study, he added, "provided a package of benefits to all participants they would not have had otherwise, and all the homes in the study had less lead dust than homes where no preventive action had been taken.
"We did this study to get these children out of lead-risk traps, inner-city homes that are awash in lead paint," said Goldstein. "Thirty years ago, one out of every three children admitted to KKI’s hospital was admitted for lead poisoning, and every year for decades a dozen children died of it. Because of our research and pursuit of achievable solutions to this epidemic, no children have died of lead poisoning in the last several decades in Baltimore.
"But ten years ago, children were still being poisoned with alarming frequency. That was so frustrating. We knew how to stop the poisoning, we knew what to do, but we needed to conduct the 1992 study to demonstrate how well these prevention methods worked. And that’s what the study accomplished." Lead poisoning still remains the No.1 one preventable environmental health hazard for children.
In their amicus brief, JHU, UMMS, the AAMC and AAU take strong issue with the language and scope of the Court’s opinion with respect to the issue of parental and guardian consent for participation of children and non-competent adults in research, saying "the Court should review, reconsider and rescind that portion of its decision" whose unintended consequences would seriously damage vital research. (The University of Maryland School of Medicine has filed a separate amicus brief regarding this issue of participation of children in research studies.)
The Court of Appeals had ruled that a "parent, appropriate relative or other...surrogate" cannot consent to such participation "in nontherapeutic research or studies in which there is any risk of injury or damage to the health of the subject."
Before this ruling, Maryland law and federal regulations specifically allowed parents and guardians to give such consent – under strict guidelines – for research even though it brought no direct benefit to the participant. The supporting brief argues that if the Court’s ruling stands, research in cases involving children and other legally disabled individuals cannot take place in Maryland and the "overall cost in terms of lost advances in medical and health knowledge (and ultimately lost opportunities to cure diseases and prevent suffering and loss of life) will far outweigh the asserted advantage of protecting individual rights."
Hopkins and KKI officials emphasized that they are not asking for any changes in Maryland’s consent laws. But they do say that the Court of Appeals fashioned a ruling that imposes radical consequences for all research in this state without benefit of full facts and arguments on these issues, and without consideration of the ramifications of this extraordinary ruling.
The amicus brief went on to say that while the issues of human research protection with which the Court grappled are serious, the very seriousness suggests a need for a "far more cautious approach and a far narrower decision than the one the Court issued."
Among the unintended consequences of the Court’s broad holding, the supporting brief states, even research involving no more than needle sticks to draw blood would be halted. In addition, children afflicted with serious diseases for which there is no treatment or cure "will be denied the benefit of any experimental therapy," and work on development of new vaccines would be prohibited because these could not be given to healthy children to demonstrate safety and the ability to cause an immune response.
If the Court opinion is allowed to stand, much valuable cutting edge research would also be forbidden, including efforts to identify early risk of Alzheimer’s Disease. Studies to learn whether normal children whose parents have diabetes are at risk for developing the disease would also grind to a halt.
"A number of very important academic organizations have come forward to say that the Court needs to reconsider parts of its ruling," according to William R. Brody, M.D., President of The Johns Hopkins University. "Their support underscores what is at stake, not simply for the research community but, more importantly, for the health of our children."
Adding further context to Kennedy Krieger’s brief today, Goldstein acknowledged that the study was, as many carefully designed research protocols are "enormously complicated. This is not a study that can be explained in 20 minutes or in quick sound bites and that has led to perhaps understandable confusion about the nature and goals of the study."
One such point of confusion, he added, involved tests for lead levels in the children participating in the study. Noting that any blood tests showing an elevation in lead levels in children were reported the same day to families and to the City of Baltimore for further action, he said that lead levels in nearly all the children dropped after the houses were cleaned -- some by significant amounts. According to Goldstein, there was "absolutely no delay in reporting the critical blood lead level test to families."
Added Goldstein, "This study’s success in demonstrating the effectiveness of preventative measures for reducing lead paint hazards is now a national model, embraced by the U.S. government and duplicated in 13 other cities."
For further facts and information about the lead paint study, Kennedy Krieger and Hopkins, go to www.hopkinsmedicine.org. For press inquiries only, contact Amy Elias at 410-382-8330 and Joann Rodgers or Gary Stephenson at Hopkins at jrodgers@jhmi.edu, gstephenson@jhmi.edu, 410-955-6680.