http://www.nytimes.com/aponline/national/AP-Hopkins-Drug-Trial.html

 

November 12, 2001

Johns Hopkins Sanctions Scientist

By THE ASSOCIATED PRESS

 

 

Filed at 2:38 p.m. ET

BALTIMORE (AP) -- Johns Hopkins University sanctioned a researcher who tested experimental cancer drugs on patients in India without the approval of a university review board, the school announced Monday.

The sanctions, the latest in a series of embarrassments for the university involving human subjects, were based on the findings of a faculty committee appointed in July. It investigated a study by Ru Chih C. Huang, a biology professor in the Krieger School of Arts and Sciences, which is separate from the medical school.

The committee did not find any evidence that patients were harmed. It also found that Huang did not conduct adequate preliminary tests of the cancer drugs on animals.

The university said it has barred Huang from serving as lead investigator on future research involving human subjects and mandated that a senior faculty member supervise her if she participates in any studies on humans led by other researchers.

The committee's report was not made public, university spokesman Dennis O'Shea said, and Huang was not named in university statements due to a confidentiality policy.

Huang's study was conducted with collaborators at the Regional Cancer Centre in the southern India state of Kerala. The study, involving 26 oral cancer patients, ran from November 1999 to April 2000. Researchers tested whether a chemical derived from the creosote plant could stop the growth of oral cancer.

In July 2001, reports appeared in Indian news media of complaints by physicians that the trial had been improperly conducted.

The doctors reportedly questioned whether researchers had received proper permission from patients, whether surgery or other treatments were delayed, and whether the drug had been screened for toxicity.

Huang said all the patients consented, and blamed the dispute on confusion between the chemical used, M4N, and NDGA, a toxic derivative of the creosote plant. M4N is not toxic, Huang said.

She said she did not submit her study to a Hopkins review board because the research was approved by a similar RCC panel. She said she was not aware that Hopkins requires internal approval for studies conducted abroad.

Huang, a faculty member since 1965, can appeal the decision.

In July, federal regulators shut down most human research at the university for five days after a healthy 24-year-old volunteer died after participating in an asthma study. In August, Maryland's highest court criticized a study conducted by the Kennedy Krieger Institute on poor children exposed to lead-based paint.

On Friday, the federal Office of Human Research Protection said the university's medical school and affiliated institutions should be commended for changes made since the volunteer's death, but criticized two other studies.

In one study, the regulators said a researcher failed to warn parents about serious side effects of hormones used in a study on children. In the other, researchers were criticized for giving cocaine addicts up to $700 to get them to participate.

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On the Net:

The Johns Hopkins University: http://www.jhu.edu

Regional Cancer Centre in Kerala, India: http://rcctvm.org/index.htm

 

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