-Caveat Lector-
'My kids were used as guinea pigs'
Lead paint study adds to debate on research
Viola Hughes, 29, has a 9-year-old daughter who lawyers claim
suffers developmental disabilities due to high levels of lead in
their Baltimore apartment.
By Manuel Roig-Franzia
THE WASHINGTON POST
Aug. 25 - The plastic cylinders of green cleaning powder kept
showing up at Jacqueline Martin's row house during that anxious
summer of 1994. Every time she complained about the increasing lead
levels in the blood of her 2-year-old daughter, Anquenette
Carpenter, she would get another supply of cleanser from the woman
she still calls "Miss Ruth," a researcher with the renowned Kennedy
Krieger Institute.
MIX IT WITH WATER and the lead dust will go away, Martin
remembers being told. Clean the windowsills. Clean the floors.
Everything will be okay.
But it wasn't. Anquenette's lead levels got worse. Soon,
Martin began to hate that green powder, which came to represent so
much to her.
"I felt betrayed," said Martin, whose other daughter,
5-year-old Ashley Partlow, also lived in the row house. "I felt
like my kids were used as guinea pigs."
There is now a pitched debate about the ethics of the
mid-1990s Kennedy Krieger study that encouraged landlords to rent
lead-contaminated homes to Martin's family and many of the 107
other poor, Baltimore families with young children in the research
project. The study, overseen by Johns Hopkins University, was
denounced last week by Maryland's highest court, which compared it
to the infamous Tuskegee, Ala., experiments that withheld treatment
from black men infected by syphilis.
RIGHTS AT ISSUE
The court's outraged opinion - which also accused Kennedy
Krieger of inadequately informing parents of the study's risks and,
in effect, using their children as "canaries in the mine" - is
further shaping the complex debate about the rights of human
research subjects.
Baltimore judges had dismissed two lawsuits filed against
Kennedy Krieger by mothers of children in the study even before
lawyers could finish gathering information. Now that Maryland's
highest court has reversed those decisions and ordered trials, the
study's methods will finally get a public airing, offering a window
into the veiled world of high-stakes human research.
At the same time, the Kennedy Krieger study also is being
scrutinized by the agency that last month halted for five days
federally funded research involving human subjects at Hopkins after
the death of a healthy volunteer in an asthma experiment. The probe
is being watched eagerly by the single mothers who filed suit
against Kennedy Krieger: Catina Higgins, Martin's roommate, and
former West Baltimore resident Viola Hughes. Lawyers for Martin
also are preparing a suit.
The federal probes, by the Office for Human Research
Protections, into the lead paint and asthma studies have focused in
large part on the actions of the panels of Hopkins faculty members,
known as institutional review boards, which are charged with
scrutinizing the methodology of medical studies. In his scathing
opinion last week for the Maryland Court of Appeals, Judge Dale R.
Cathell leveled blunt criticisms at the review board that oversaw
the lead paint study, saying "the medical and scientific
communities" should no longer be given sole authority for research
involving children.
Hopkins and Kennedy Krieger have close ties, but are
independently run. Kennedy Krieger is allowed to conduct human
studies because it has been listed as an affiliate on Hopkins's
federal human research permit.
The lead paint study focused on the hardscrabble
neighborhoods in West and East Baltimore, where Kennedy Krieger
researchers estimate that 95 percent of the thousands of row houses
built before World War II are contaminated by lead paint. The
purpose of the study was to determine the minimum amount of lead
cleanup that could be undertaken and still protect the health of
children.
The researchers split their subjects into four groups of row
houses, each receiving varying degrees of lead cleanup. Kennedy
Krieger's lawyers, S. Allan Adelman and Michael I. Joseph of
Rockville, have said in court papers that the homes the children
were to live in had to have elevated lead levels to be included.
A fifth group lived in modern homes with no lead paint.
The researchers doled out grants for cleanup work in the
contaminated homes to landlords, who were given instructions to
rent the homes to families with small children. Some occupied homes
also were included in the study, as long as there were small
children living there. The children could not be mentally disabled
or have sickle cell anemia. All of the children in the study were
tested to measure the effectiveness of the different cleanup
methods.
Hughes lived in a house that Kennedy Krieger's lawyers said
had undergone a complete cleanup before she moved in, though her
attorneys contend that test results showing high lead levels in the
house were withheld from her. Higgins and Martin moved into a home
that had been given a partial cleanup, which included established
lead removal techniques such as sealants to make floors easier to
clean and installation of aluminum covers on door trims.
Lawyers for Higgins and Martin say it was unfair that their
clients moved into a home that had received only a partial
abatement when others in the study got more extensive abatements.
Kennedy Krieger officials say placement was a matter of
chance. When homes in the study were available, landlords placed
ads. Sometimes the homes had received major cleanup work, sometimes
not.
WITHOUT WARNING
Kennedy Krieger chief executive Gary W. Goldstein and the
study's supervising researcher, Mark Farfel, have adamantly
defended the research methods, though they have declined to talk in
detail about the cases of the women who have sued. Goldstein and
Farfel say the three-year research effort took an innovative
approach by identifying rental homes that might have been abandoned
by landlords concerned about high cleanup costs.
"We would feel very differently if somehow we looked at it
and said 'We really screwed up here,' " Goldstein said this week.
"But we didn't do that."
Lawyers for Higgins, Martin and Hughes have argued that
Kennedy Krieger did not do enough to warn them about the risks of
the study, an accusation that was affirmed in Cathell's opinion.
The women signed consent forms that stated "lead poisoning in
children is a problem in Baltimore," but the forms made no mention
of specific health effects or that the researchers expected
children in the study to accumulate lead in their blood.
Kennedy Krieger's lawyers have argued that the institute did
not have a legal obligation to warn the study's subjects about the
risks, saying the consent forms signed by participants are not
binding contracts.
Such positions, relying on technical interpretations of the
law, have drawn the ire of groups that advocate reforms.
"There is a culture that has grown up among researchers; it
puts science above human beings - and that's a very dangerous
thing," said Vera Hassner Scharav, of the Alliance for Human
Research Protection, a privately funded New York advocacy group.
Dangerous Levels
When the Kenedy Krieger study started, the children of
Higgins, Martin and Hughes all had lead levels either below or
slightly above the 10 microgram per deciliter safety standard set
by the Centers for Disease Control, according to the children's
attorneys. But those levels rose quickly.
In seven months, the levels for Higgins's son, Myron
Higgins, now 11, went from six micrograms to 21, according to
Suzanne C. Shapiro, who represents the Higgins family. The levels
for Hughes's daughter, Ericka Grimes, went from 9 micrograms to 32,
her attorney, Kenneth W. Strong said; the levels for Martin's
daughter, Anquenette, whose name was recently changed to Charnice,
went from 10.7 micrograms to 24, said Shapiro, who also represents
the Martins. No test results are available for Martin's other
daughter, Ashley.
Blood levels of 20 or above have been shown in studies to
lead to reduced IQs, while blood levels of 24 or above have been
shown to increase the chances of mental retardation, according to
the American Academy of Pediatrics.
Goldstein and Farfel say rising lead levels were not the
norm in the study. They said researchers tracked declining lead
levels for most children who registered above 15 on the
contamination scale and that children with blood levels around 10
did not get worse.
NEW OPPORTUNITIES
Hughes, Higgins and Martin were all poor and had bounced
between welfare and low-paying jobs. Hughes, who has a general
studies degree from Baltimore City Community College, is the only
one who graduated from college.
Hughes, 29, lived in a row house about 3 ˝ miles from the
home that Martin and Higgins shared. She moved there in 1990, with
her sister and mother, after years living on the 11th floor of the
notorious Lafayette Gardens public housing development, with its
constant presence of guns and drugs.
The $425-a-month row house on North Monroe Street sat
between a funeral home and a liquor store on a busy street, but it
was a big improvement over the squalid environment at Lafayette
Gardens, which has since been torn down.
Hughes's daughter, Ericka, was born in 1992. The next year,
a Kennedy Krieger representative signed up the young mother for the
lead paint study.
At first, the study seemed like a great idea - free testing
and only a little inconvenience - and she certainly didn't mind
getting the $5 or $15 payments each time she filled out
questionnaires or brought in little Ericka for testing.
But, like Martin, Hughes said she was getting increasingly
worried during late 1993 and the summer of 1994. The reports she
got from Kennedy Krieger showed rising lead levels in Ericka's
blood. Hughes also turned to Miss Ruth. But the problem persisted.
Kennedy Krieger did not respond to requests to interview
Miss Ruth, and her last name could not be confirmed.
Now, Hughes wonders whether the lead is responsible for her
daughter's learning disabilities, attention problems and troubles
at George Washington Elementary School, where Ericka had to repeat
the second grade. Hughes wonders most on the days when Ericka comes
home crying and asks: "Mommy, I'm stupid?"
"I'm like, 'No baby, you're not stupid. We just have to work
harder,' " Hughes said this week.
Martin, 27, said her children also have struggled at school,
especially Ashley, who was 5 when the study started.
"She's slow; she's not on the level she should be," Martin
said.
Higgins could not be reached to discuss the case.
While the study was being conducted, Martin and Hughes said
they accepted small gifts from Kennedy Krieger when they took their
children in for testing. Martin remembers Ashley and Anquenette
getting a few stuffed animals and some stickers. Hughes was given
vouchers for free food at a Baltimore farmers market.
"I thought it was just an incentive," Hughes said. "A lot of
people pay you to take surveys. I didn't know a whole lot about
it."
'MY KIDS WERE IN DANGER'
Their homes also were being tested. There is much dispute
about the testing of Hughes's home, in particular, because Kennedy
Krieger gave her test results that showed low levels of
contamination and withheld results that showed high levels.
Strong accuses Kennedy Krieger of hiding critical
information, but the hospital's lawyers say the high-level results
were not disclosed because they were measured with an experimental
device.
Throughout the study, the mothers of children with high lead
levels were being told by Kennedy Krieger to share the test results
with their doctors, court documents state.
But such referrals were little comfort for Martin and
Hughes. Eventually, they decided to move, each leaving in 1995.
"I knew my kids were in danger," said Martin, who now lives
with her mother. "I needed to get out of that house. I even tried
to get subsidized housing."
Keeping It Quiet
Kennedy Krieger will not release the names of the study
subjects, citing the confidentiality of medical records. Farfel and
Goldstein say no attempts have been made to contact them though the
lawsuits have raised questions about the safety of the experiment.
The hospital's last contact with study subjects was about 1 ˝ years
ago for routine follow-ups, Farfel said.
Some lawyers who have represented human subjects say the
hospital should be reaching out.
"There's a moral, an ethical and a legal obligation to
notify the people and if they don't notify the people, to notify
the press so they can notify the people," said Alan Milstein, a New
Jersey lawyer.
But Goldstein and Farfel said no notifications are necessary
and that the study already has improved the lives of most
participants. They describe poor Baltimore neighborhoods as awash
in lead hazards. If the study subjects hadn't moved into homes
linked to the Kennedy Krieger research, Goldstein said, they would
have ended up in other contaminated homes, maybe ones that were
receiving no treatments.
"It's not that we intercepted people who were on their way
to some treasure trove of lead-safe houses in Baltimore and
directed them to houses with lead paint," Goldstein said.
Asked whether he would change anything about the study,
Goldstein thought for a moment, then said, "I don't think so."
Then, he paused again, adding, "That's not to say a mistake
couldn't have been made."
© 2001 The Washington Post Company
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