Hopkins investigates drug study in India

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Hopkins investigates drug study in India

July 31, 2001 Posted: 10:40 AM EDT (1440 GMT)

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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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RELATED STORIES:

• HHS faults Hopkins research procedures
July 20, 2001
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RELATED SITES:

• Regional Cancer Centre, Kerala, India
• The Johns Hopkins University: Medicine
• Office for Human Research Protections

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