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By Tamar Lewin
Amid growing concern about the safety
of medical research involving humans, the Department of Health
and Human Services opened an investigation on Wednesday into
a lead-paint study in Baltimore overseen by Johns Hopkins
University.
The study was criticized in August 2001
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 months 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."
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.
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.
The New York
Times, August 24, 2001
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