Johns Hopkins admits scientist used Indian patients as guinea pigs

The Johns Hopkins University has admitted that a staff scientist collaborated with Indian doctors to test an experimental cancer drug in Indian patients without establishing its safety through animal tests.

The university announced last week that it had initiated sanctions against the scientist for participating in clinical trials that did not meet the university's standards for human research.

The scientist had provided the drug to doctors at the Regional Cancer Centre in India's southern state of Kerala. The doctors injected it into 26 patients with oral cancer between November 1999 and April 2000.

The university declined to name the scientist involved in the trial, but doctors at the publicly funded cancer centre have named Ru Chih Huang, a professor of biology at the university, as their collaborator.

Earlier this year a radiobiologist at the centre had accused his colleagues of breaching ethics by conducting an unauthorised clinical trial on unapproved drugs without appropriate consent (11 August, p 299).

The charges by Dr V Narayan Bhattathiri that patients in India were being used as “guinea pigs” had prompted the Indian health ministry and Johns Hopkins to launch independent investigations of the trials.

A committee appointed by the Indian health ministry has submitted its findings to the government, but its report has not been made public. The health ministry had said that it would order a change in the institutional ethics review panel at the centre.

Senior doctors at the centre declined to comment on whether any other clinical trials have been ordered to stop. “The attitude now is to just forget that it ever happened,” said Dr Bhattathiri. “There are lessons to be learnt from this episode,” he said.

Health authorities in India have expressed concern that the country's large pool of patients, trained medical researchers, and lack of strict laws to govern clinical trials make it an attractive site to test new drugs.

The Johns Hopkins University committee said that there was inadequate safety testing of the drugs (synthetic derivatives of a plant product called nordihydroguaiaretic acid) in animals before they were injected into human patients. It also confirmed Dr Bhattathiri's claims that consent forms used to recruit patients were inadequate.

The university has barred its scientist from serving as principal investigator on any future research involving human subjects.