Drug trial found unsafe

Hopkins biologist barred from leading human research

Unapproved cancer study

Officials say toxicity of chemical injected into 26 is unknown

November 13, 2001|By Tom Pelton | Tom Pelton,SUN STAFF

The Johns Hopkins University barred a biologist yesterday from directing experiments on humans after concluding that she performed a cancer drug trial in India without following safety procedures.

Ru Chih C. Huang, a professor at the school of arts and sciences, didn't seek university or government approval for a test of a chemical derived from the creosote bush on the oral cancers of 26 people, according to the university.

Huang, a faculty member at the Homewood campus since 1965, should have tested the chemicals more thoroughly on animals to determine whether they were toxic before giving them to people, according to university officials.

Administrators have no evidence that anyone was harmed by Huang's activities. But because of the potential for danger, the university has prohibited the professor from leading similar research, university officials said yesterday.

"This is a very serious matter," said Richard McCarty, dean of arts and sciences. "We are doing everything necessary to make sure that it won't be repeated in the future."

Hopkins began investigating the study after an Indian doctor complained about its safety to Indian newspapers. The disclosures about Huang's errors occur at a sensitive time for the university, when its medical school is working to rebuild its image after the death of a young woman in an asthma experiment June 2. After that incident, the federal Office of Human Research Protection briefly suspended human experimentation at Hopkins.

The agency is not looking into Huang's drug trial because the university seems to have aggressively investigated the problem on its own, said Bill Hall, an agency spokesman.

Huang will be allowed to assist other researchers as they experiment on humans in the future if she is closely supervised by a senior faculty member, according to a university statement.

The biologist said yesterday that Hopkins was partially responsible because it did not tell her that she had to seek approval from the university's internal review board for a trial at a foreign medical center.

"I am a basic science researcher, and I just did not know that Johns Hopkins approval was needed for a trial in India," said Huang.

Very few professors in the school of arts and sciences conduct experiments on humans. Most research of that kind is conducted by the medical school or other affiliated institutions.

Huang said her intention in carrying out the trial was "to help patients with oral cancer with a very promising new compound." She said she chose India because of the high incidence of the disease in the population.

Without university approval, Huang signed several documents committing Johns Hopkins to collaborating on the cancer trial with Regional Cancer Center in the southern India state of Kerala, according to a three-member faculty panel that examined Huang's study.

Huang extracted a chemical called M4N from creosote bushes, which Native Americans have used for medicinal purposes for centuries. From November 1999 to April last year, she and her fellow researchers in India injected the chemical into tumors on the lips of 26 people who were scheduled to have the growths surgically removed.

After surgeons removed the tumors, Huang examined the cells and found that the cancers showed signs of shrinking or dying. All but two of the patients lived. One died of heart disease and the other died of cancer, according to Huang.

Johns Hopkins Treasurer William E. Snow Jr. signed checks for at least $19,400 that were sent to the Kerala cancer center, the newspaper The Hindu has reported. Huang said she and her husband donated that money to the university for the project because they thought it was important for the fight against cancer and that the university wired the money to the Kerala center.

"The university says they didn't know about it, but that is wrong. They knew about it since 1999, and they wired the money to pay for it," said Huang.

University officials said yesterday that the treasurer's office had apparently endorsed checks for the project, not knowing that the university's Institutional Review Board had not approved the project.

"The process of making funds available is different from the process of IRB approval," said Hopkins spokesman Dennis O'Shea.

Huang said she and colleagues plan to conduct a series of experiments with the cancer drug. After the Indian study, Singapore businessman Ang Tiong Loi pledged a "multimillion-dollar" investment in her research, according to the Johns Hopkins University Gazette.

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