- The Washington Times - Tuesday, November 13, 2001

BALTIMORE 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 yesterday.
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. The panel investigated a study conducted 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 also found that Miss Huang did not conduct adequate preliminary tests of the cancer drugs on animals, but did not find any evidence that patients were harmed.
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 harshly rebuked 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 study, researchers were criticized for giving cocaine addicts up to $700 to get them to participate in a study.
In the Huang case, the university said it has barred the researcher from serving as lead investigator on any 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.
"It was a diligent and thorough investigation, and the dean has imposed sanctions that he feels are consistent with and appropriate, given the results of the investigation," university spokesman Dennis O'Shea said.
The committee's report was not made public, Mr. O'Shea said, and Miss Huang was not named in the university's statements because of an internal confidentiality policy.
Miss Huang's study was conducted with collaborators at the Regional Cancer Centre (RCC) 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 the 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.
Miss Huang said consent was received from all patients involved, and blamed the dispute on confusion between the chemical used, M4N, and NDGA, a toxic derivative of the creosote plant. M4N is not toxic, Miss Huang said.
The committee's findings released yesterday addressed some of those concerns. Among them:
Miss Huang failed to submit a proposal for the clinical trial to an internal JHU review board, which must approve all studies involving human subjects, whether conducted in the United States or abroad.
The drugs had not been adequately tested on animals before they were injected into human subjects.
Consent forms used to recruit patients were inadequate.
Miss Huang carried drugs used in the study to India with neither an "investigative new drug" approval from the U.S. Food and Drug Administration, nor FDA export permission.
The scientist, without authority, signed several versions of a document committing JHU to collaboration with the RCC.
Miss Huang, a faculty member since 1965, has the option to appeal the decision.


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