http://www.cnn.com/2001/HEALTH/07/31/hopkins.drug.trial.ap/index.html
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Hopkins
investigates drug study in India
July 31, 2001 Posted: 10:40 AM EDT (1440
GMT)
BALTIMORE, Maryland (AP) -- In another blow
to Johns Hopkins University, a faculty member who did a cancer study in India
is being investigated for possible violations of rules on research involving
human subjects. The announcement of the investigation Monday
comes nearly two months after the death of Ellen Roche, a healthy 24-year-old
lab worker who was taking part in an asthma study at Hopkins' medical school.
The Office for Human Research Protections, a
division of the Department of Health and Human Services, temporarily shut
down nearly all of Hopkins' federally funded research on human subjects
because of Roche's death June 2. The researcher in the India study, biology
professor Ru Chih C. Huang, did not receive a Hopkins review board's approval
for the cancer study and was ordered to stop working on it, the university
said. The school also is investigating whether the drug used had been
properly screened and other questions. Huang said she did not submit her study,
conducted at the Regional Cancer Centre in Kerala, India, to a Hopkins review
board because the research was approved by a similar panel at the center.
Huang, a faculty member since 1965, said she was not aware that Hopkins
requires internal approval for studies on humans conducted abroad. The study, conducted on 26 patients in 1999 and 2000,
tested whether a chemical derived from the creosote plant could stop the
growth of oral cancer. It was done in India because the type of tumor is more
prevalent in that part of the world, Hopkins spokesman Dennis O'Shea said. "I will never do this again in this
way," Huang told The Sun. "But certainly I did not hurt the people
in that country in any way, and I think that this will prove to be an
effective anticancer drug." Estelle Fishbein, Hopkins' vice president and
general counsel, informed the federal Office for Human Research Protections
of the investigation in a letter dated Friday. "We are not aware of any information that
would lead us to believe that the university was either aware of, or
otherwise condoned, any possible misconduct," Fishbein wrote. Bill Hall, a spokesman for the federal agency,
said Hopkins handled the incident appropriately. Hall would not speculate on
whether the federal agency would launch its own investigation. Hopkins receives more federal research money
than any other institution in the country -- more than $300 million last
year. The university said it learned of the study in
March and told Huang the study should have had the board's approval. The
university also ordered her to follow university procedures for a follow-up
study. The university said Indian media reports cited
concerns about the study raised by doctors at the cancer center. The doctors reportedly questioned whether the
researchers received proper permission from patients, whether surgery or
other treatments were delayed, and whether the drug had been screened for
toxicity. Huang said consent was received from all
patients involved, and blamed the safety concerns on confusion between the
chemical used in the study, M4N, and another derivative of the creosote plant
which is toxic. M4N is not toxic, Huang said. "You try to help people in a poor country,
and they are putting out all of these false and evil things about you,"
she said. Copyright 2001
The Associated Press.
All rights reserved. This material may not be published, broadcast,
rewritten, or redistributed.
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© 2001 Cable News Network LP, LLLP. |
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