Probe Opens on Study Tied to s Hopkins

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http://www.washingtonpost.com/ac2/wp-dyn/A49123-2001Aug22?language=3Dprinter

Probe Opens on Study Tied to s Hopkins=20

By Roig-Franzia

Washington Post Staff Writer

Thursday, August 23, 2001; Page B01=20

BALTIMORE, Aug. 22 -- The federal agency that monitors research involving

human subjects has opened an investigation into a lead paint study overseen

by s 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 s 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 land 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.

s 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. s Hopkins receives more

federal research dollars than any other medical school in the country.

s 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 s 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 s Hopkins faculty members, known as an institutional review

board, oversaw the Kennedy Krieger lead paint study. land 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 and Catina Higgins,

whose children were involved in the study. '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.=20

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 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.

=A9 2001 The Washington Post Company=20

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