The Johns Hopkins University is investigating a researcher who tested an experimental anti-cancer drug on patients in India without seeking the permission of an internal review board that considers the safety of human studies, a spokesman said yesterday.
The experiment, which was conducted on 26 patients in 1999 and 2000, sought to determine whether a chemical derived from the creosote plant could stop the growth of oral cancer.
Ru Chih C. Huang, a Hopkins biology professor, said yesterday that she did not submit her study to a Hopkins review board because it was approved by a similar panel at the Indian cancer center where the trial was performed. A faculty member since 1965, Huang said she did not realize that Hopkins requires internal approval of experiments conducted abroad.
"I will never do this again in this way," Huang said. "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 anti-cancer drug."
Hopkins knows of no reports of anyone being injured in the study, said spokesman Dennis O'Shea.
The inquiry comes on the heels of a federal investigation of human experiments at the Johns Hopkins School of Medicine, its two teaching hospitals and several affiliated institutions.
This month, a federal agency briefly suspended human studies throughout the Hopkins medical complex after finding widespread lapses in safety procedures. Regulators said the review boards were not providing enough scrutiny of medical experiments. The federal investigation was triggered by the death June 2 of a young, healthy woman who had volunteered for an asthma experiment at Hopkins' Bayview Medical Center.
Huang's study was unusual because she holds a faculty position at the School of Arts and Sciences on the Homewood campus, where comparatively little drug research is done. The school was not a target of the federal investigation.
The trial has been criticized recently by an Indian physician who works at the Regional Cancer Center in Kerala, where the research was conducted. In a complaint to an Indian human rights commission, he said the drug was used on patients before standard therapies were given, thus delaying potentially helpful treatment.
Dr. V.N. Bhattathiri, a radiologist, also alleged that doctors did not get informed consent from patients and that the drug was not adequately screened for toxicity, according to an Indian newspaper, The Hindu. He said the experiment exposed patients to risks that would not have been permitted in the United States.
Research by Western scientists and drug companies in developing nations has proven controversial in recent years, with critics alleging that safety precautions are weakened when studies are conducted overseas.
In an interview yesterday, Huang said all the patients received standard surgical treatment in addition to the experimental drug. She said the drug was injected into patients' tumors several days before the surgery.
She said she found that in all of the patients, the tumors showed signs of shrinking before the surgery. All but two of the 26 patients survived the term of the study. One died of heart problems, another of cancer, she said.
"The patients all had consent forms," 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."
Huang said the recent dispute arose because of an misunderstanding. She said Bhattathiri had confused NDGA, a toxic derivative of the creosote plant, with M4N, the chemical she was using. Huang said her compound is not toxic.
She said she chose India for the clinical trial because she wanted a population with a high rate of oral cancer, a deadly disease caused mainly by smoking and chewing tobacco.
O'Shea said the study came to the attention of Hopkins officials in March when the researcher told a university administrator of plans to conduct a follow-up experiment.
The official was not aware of the original study and was surprised to learn it had taken place without the approval of a Hopkins institutional review board, O'Shea said. Huang was told that any further study would need review board approval, he said.
There was no indication of anything more than procedural problems until July 16, when Hopkins officials read accounts of a simmering controversy in the Indian press. Hopkins immediately began a preliminary inquiry to determine whether there had been violations of policies on the protection of human subjects, O'Shea said.
"This inquiry found that the study in question had not been authorized by any department," said O'Shea. Neither had it been approved by any of the university's institutional review boards.
Hopkins has appointed a new panel of experts to conduct a formal investigation. The university reported the matter Friday to two federal agencies, the Office for Human Research Protections and the Food and Drug Administration.
Bill Hall, a spokesman for the Office for Human Research Protections, said it is not investigating the incident but asked Hopkins to keep regulators informed about its findings.
Though the research does not involve the medical school, Huang's follow-up study is now before a medical school review board.
Huang said Hopkins may be especially sensitive about issues of review board approval because of the death of the asthma study volunteer. "When the asthma incident happened, naturally they want to be more careful, and I understand that," Huang said. "I did not do anything wrong."
The study was funded by $2 million from Biocure Medical of Minnesota. Hopkins holds a patent on the drug and could profit if the company can bring it to market as a cancer treatment, Huang said.