In response to a request to Dr. William R. Brody, President, the Johns Hopkins University, seeking clarifications and comments on the drug trial controversy, the university's press spokesman and Executive Director, Communications and Public Affairs, Dennis O'Shea, wrote back to R. Krishnakumar on July 27, disclosing for the first time that the 'Hopkins-RCC drug trial study' had not been authorised by any department of the university. The text of the statement, sent by e-mail, is reproduced below:
In late March 2001, officials at the Johns Hopkins University became aware of a 1999-2000 clinical trial in India of an experimental anti-cancer drug developed by a faculty member in the university's Krieger School of Arts and Sciences. 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 the faculty member's involvement in the trial, the protocol also should have been submitted to and approved by a Johns Hopkins institutional review board before the study began. The faculty member was required to submit the protocol for a planned follow-up study to an institutional review board.
That protocol has been submitted and has been under review, but has not been approved.
On July 16, the university learned from a report in the news media in India that physicians at the Regional Cancer Centre in Kerala had raised serious allegations about the conduct of the 1999-2000 trial. Among these, reportedly, were allegations regarding whether proper informed consent had been secured from patients, whether surgery or other conventional treatment had been delayed because of the administration of the experimental drug and whether the drug had been properly screened for toxicity before it was administered.
When it learned of these allegations, the university immediately launched a preliminary inquiry to determine whether there had been violations of its policies regarding the protection of human subjects. This inquiry uncovered credible evidence that university policies were violated, and the university has now appointed a panel of experts who will conduct a formal investigation.
Among the findings of the preliminary inquiry was that the study in question had not been authorised by any department of the university, and confirmation that it had not been reviewed or approved by any of the university's institutional review boards.
The faculty member has been directed to cease all activities related to the study in question. As a member of the faculty, the researcher has the right to a fair and proper procedure to determine the truth of the allegations that university policies were violated. Johns Hopkins will respect those rights and will follow its procedures. It would be premature, therefore, to comment further on the facts of the case until the investigation is complete. In the meantime, we have informed the U.S. Food and Drug Administration and the Office of Human Research Protection of our investigation.
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