August 24, 2001
Additional details are emerging about the lead-paint study conducted on infants and children by researchers at the Kenney Krieger institute which is affiliated with Johns Hopkins University. Today's New York Times reports (below) that the child's blood level was "at a safe level" when enrolled into the lead paint study, but that after one month his "blood contained excessive lead, and that he had since had neurological problems." The experiment elicited a scathing decision by Maryland's highest court which compared the use of children in non-therapeutic medical experiments to the use of "canaries in the mines" and made reference to Nazi atrocities and the infamous Tuskegee experiments.
Yesterday's Washington Post (below) reported discrepant statements by federal officials from the Office of Human Research Protections (OHRP) and spokespersons for Hopkins. OHRP claimed the agency's investigation of the lead study "was launched before the court's opinion was issued [Aug 16]." Hopkins denied any request from OHRP until Wednesday, when OHRP faxed a letter asking "to review one aspect of the lead paint study." The Times reports that the Department of Health and Human Services opened the investigation on Wednesday. One wonders how this matter can be adequately assessed if only "one aspect" is to be questioned.
Furthermore, The Post reported that "Since the court issued its ruling regarding the lead paint study, the institute has continued its research with two studies related to lead paint. In one, half of the participants -- children ages 1 to 8 -- receive a drug known to reduce elevated levels of lead in the blood, while the other half receive a placebo." How can such experiments be allowed to continue inasmuch as these children may be similarly exposed to undue harm?
This failure to take proactive measures to protect children underscores AHRP's concerns about their safety in improperly evaluated, and hastily approved research projects. In the zeal to get research done, even blatant violations--such as the Court censured--are simply overlooked by the current dysfunctional research oversight system.
THE NEW YORK TIMES
AUG 24, 2001
U.S. Investigating Johns Hopkins Study of Lead Paint Hazard
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 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.
Copyright 2001 The New York Times Company
Probe Opens on Study Tied to Johns Hopkins
By Manuel Roig-Franzia,
Washington Post Staff Writer
Thursday, August 23, 2001; Page B01
BALTIMORE, Aug. 22 -- The federal agency that monitors research involving human subjects has opened an investigation into a lead paint study overseen by Johns Hopkins University and conducted by its affiliate, the Kennedy Krieger Institute, in the mid-1990s.
The same agency recently halted for five days all federally funded medical research at Johns Hopkins involving human subjects after a similar investigation into a Hopkins asthma study that resulted in the death of a healthy volunteer.
The lead-paint study, which recruited healthy children and their families to live in Baltimore houses with varying amounts of lead contamination, was denounced by the Maryland Court of Appeals in an opinion issued last week. Six of the seven judges who heard the case likened the study to an infamous 1940s Tuskegee, Ala., study that withheld treatment from black men infected with syphilis.
The investigation by the Office for Human Research Protections -- an agency of the U.S. Department of Health and Human Services -- was launched before the court's opinion was issued, although federal officials would not say exactly when it began.
Johns Hopkins and its affiliates, including Kennedy Krieger, have permission to conduct experiments involving human subjects under a blanket order approved by the Office for Human Research Protections that will expire in October 2003, said Bill Hall, a Health and Human Services spokesman.
Since 1990, 29 percent of the 700 investigations conducted by the Office for Human Research Protections have led to temporary or permanent bans on studies involving human subjects, Hall said. Johns Hopkins receives more federal research dollars than any other medical school in the country.
Johns Hopkins officials said they were contacted by the Office for Human Research Protections about the investigation for the first time late today. A faxed letter asked Johns Hopkins to review one aspect of the lead paint study, said spokeswoman Joann Rodgers.
Rodgers declined to say what aspect of the lead paint study was mentioned in the letter or to divulge other details about its contents.
A panel of Johns Hopkins faculty members, known as an institutional review board, oversaw the Kennedy Krieger lead paint study. Maryland Court of Appeals Judge Dale R. Cathell, who wrote last week's scathing opinion, said the board instructed Kennedy Krieger researchers to write consent forms for study participants that skirted federal regulations requiring disclosure about risks.
The Court of Appeals ruling ordered trials to be held in lawsuits filed against Kennedy Krieger by two women, Viola Hughes and Catina Higgins, whose children were involved in the study. Hughes's daughter now suffers from learning disabilities and cognitive impairments, both of which are often associated with lead poisoning, according to their attorney. Higgins says researchers withheld tests results that showed high levels of lead contamination from her.
Kennedy Krieger recruited 108 families for the study, which was designed to find cheaper ways to reduce lead contamination so that landlords in poor areas here would not abandon their property.
Kennedy Krieger is a major institution in the study of lead paint abatement. Marc Farfel, who conducted the study, said today that it identified more effective ways to remove lead hazards and prompted legislation forcing landlords to remove those hazards.
Farfel and Kennedy Krieger Chief Executive Gary W. Goldstein said they were concerned about the wording of Cathell's opinion and saw no parallels between their study and the Tuskegee experiments.
"It's very inflammatory, because there is a constituency out there that is very worried . . . about experiments on minority groups," Goldstein said. He declined to identify other participants in the study, which was conducted in East Baltimore neighborhoods with high concentrations of poor and minority residents.
Since the court issued its ruling regarding the lead paint study, the institute has continued its research with two studies related to lead paint. In one, half of the participants -- children ages 1 to 8 -- receive a drug known to reduce elevated levels of lead in the blood, while the other half receive a placebo, Goldstein said.
The other study, which is in the enrollment phase, will test whether zinc tablets reduce lead in the blood.
© 2001 The Washington Post Company