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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.
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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 ½ 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 ½ 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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