http://www.nytimes.com/2001/08/24/health/children/24LEAD.html
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August 24, 2001 U.S. Investigating Johns Hopkins Study of Lead Paint Hazard
By TAMAR LEWIN
The study was criticized last week in a decision by the Maryland Court of
Appeals, which likened it to the infamous Tuskegee syphilis study decades
ago. The investigation by the department's Office for Human Research
Protections comes just a month after a five-day suspension of federally
financed medical research on humans at Johns Hopkins following the death of a
healthy young volunteer in an asthma study on June 2. The lead-paint study was conducted in the early 1990's to test how well
different levels of repair in Baltimore rental housing worked to reduce lead
in the blood of inner-city children. Two mothers later filed negligence lawsuits against the Kennedy Krieger
Institute, an affiliate of Johns Hopkins, saying that the research institute
had failed to warn them about the risks of the study and the danger that
their children could be poisoned by lead in the houses. Last week, the Maryland Court of Appeals overturned lower court decisions
dismissing those cases and sharply criticized the researchers and their
institutions as failing to see the basic impermissibility of a study that
enlisted healthy children to live in potentially dangerous housing. "It can be argued that the researchers intended that the children be
the canaries in the mines but never clearly told the parents," Judge
Dale R. Cathell said in a scathing decision that compared the Baltimore study
to Nazi medical experiments and the study in Tuskegee, Ala., that withheld
treatment from black men with syphilis. Neither researchers nor parents, Judge Cathell said, have the legal right
to put healthy children into a study that offers them no benefit and carries
real hazards. Children who ingest lead can suffer brain damage. Dr, Gary Goldstein, the chief executive of Kennedy Krieger, defended the
study and the institute's record in treating and preventing lead poisoning in
the poor neighborhoods of Baltimore. "We were not trying to put children in houses and watch them get
lead-poisoned," Dr. Goldstein said. "We did not expect anyone to
get lead-poisoned. The point was to show, in a neighborhood where 95 percent
of the houses contain lead and 35 percent of the kids have lead poisoning,
that with some repairs, you could move into a house like this and stay and
not get lead-poisoned." He added: "For the majority of kids in the study, lead levels did go
down. To compare this to Tuskegee makes no sense." Late on Wednesday, the Office for Human Research Protections sent a letter
asking Johns Hopkins, which receives more federal money for medical research
than any other university, to review the procedures used in the lead study. Neither the agency's spokesman, Bill Hall, nor the Hopkins spokeswoman,
Joann Rodgers, would provide details of the investigation. Kennedy Krieger is an outpatient institute specializing in developmental
disabilities. The procedures for its research projects are reviewed and
approved by an institutional review board at Johns Hopkins, where its
professional staff holds faculty appointments. The study was designed to test lead levels in five groups of housing. The
75 homes in three of the groups received maintenance and repairs to reduce
lead levels: 25 had minimal repairs, including scraping lead- based paint; 25
had a middle level of repairs; and 25 had extensive work, including
replacement of windows and covering floors. The study also included two
control groups, one of homes in which all lead hazards had been eliminated
and the other of houses that never had lead paint. For two years, the researchers took periodic blood, dust and water samples
to measure contamination. Kennedy Krieger helped landlords get public financing for eliminating lead
and encouraged them to rent the premises to families with young children.
Children already living in the houses were encouraged to remain, so that
their blood could be analyzed. "Through the repairs and cleaning, the homes in the study had 70 to
90 percent reduction in their lead levels, but all the families knew that
lead was still a potential, because we gave them cleaning tips about what
they should be doing to keep lead levels down," Dr. Goldstein said.
"The impression of everyone doing the study was that everyone understood
the situation." But Suzanne Shapiro, the lawyer for Catina Higgins, one of the mothers who
filed suit, said that was not the case. In May 1994, Ms. Shapiro said, when
Ms. Higgins and her 4- year-old son, Myron, moved into a rented house at 1906
East Federal Street, the lead in Myron's blood was at a safe level and his
mother knew nothing about the study. "After she moved in, Kennedy Krieger enrolled her in the study, and
she signed the informed consent, but no one ever told her, `There's lead in
this house, and and it can cause brain damage,' " said Ms. Shapiro, who
specializes in lead-poisoning cases and has other clients who participated in
the study. Ms. Shapiro said that a month later Myron's blood contained excessive
lead, and that he had since had neurological problems. |
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