'Johns Hopkins funded joint venture'

By M. Dinesh Varma

THIRUVANANTHAPURAM, AUG. 3. Adding to the controversies surrounding the clinical trial on a group of cancer patients at the Regional Cancer Centre (RCC) here, the hospital authorities were today forced to issue a statement confirming that the collaborative venture was funded by the Baltimore-based Johns Hopkins University.

The RCC statement follows media reports about the Johns Hopkins University's disowning of the clinical trial during 1999-2000 in the wake of controversy about alleged violation of patient rights.

The media statement on Johns Hopkins University's official website says that the Hopkins-RCC drug trial study had not been authorised by any of its departments.

The university's officials had in late March, 2001, become aware of a 1999-2000 clinical trial in India of an experimental anti- cancer drug developed by a faculty member of one of its medical schools, the Krieger School of Arts and Sciences, the statement said.

``The faculty member reported that the trial had been approved by the appropriate reviewing authorities in India and that proper informed consent had been obtained from patients enrolled in the study.'' At that time, the University counselled the faculty member that, because of his involvement in the trial, the protocol should also have been submitted to and approved by the Johns Hopkins institutional review board before the study had commenced, the statement said.

Accordingly, the faculty member was required to submit the protocol for a planned follow-up study to an institutional review board. However, according to the version of Johns Hopkins, that protocol had duly been submitted and was under review, but most significantly, ``not been approved''.

The University claimed that it was alerted to the controversy over the clinical trial by a media report on July 16 and had immediately launched a preliminary inquiry, which uncovered ``credible evidence that the university's policies (regarding research involving human patients) were violated, and the university has now appointed a panel of experts who will conduct a formal investigation''.

In today's terse statement, the RCC's Finance Manager (Projects), said that there was sufficient documentary proof that the University had released funds for the clinical trial led by Dr. Ru Chih Huang, Professor of Biology at Hopkins and the principal investigator for the project. The RCC possessed documents to prove that the ordering bank was the First Union National Bank, New York, and the ordering customer, the Johns Hopkins University, Baltimore.

In fact, the RCC had been regarding the collaborative venture with Johns Hopkins as a much-prized partnership. As recently as in February, the RCC authorities had issued an official statement stating that the university had decided to given an assistance of Rs. 25 lakhs per annum to the RCC for further research on the NDGA-derived medicine.

The RCC statement on February 28 had said that the NDGA-derived drug had been jointly developed by the two institutions. Preliminary studies had found that the drug was effective for some types of virus-induced cancers. The statement added that the assistance from Johns Hopkins was expected to be raised to Rs. 1.5 crores.

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