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Johns Hopkins admits staff used Indians as guinea pigs

Johns Hopkins admits staff used Indians as guinea pigs

Author: Pallava Bagla
Publication: The Indian Express
Date: November 14, 2001
URL: http://www.indian-express.com/ie20011114/top3.html

NEW DELHI, NOVEMBER 13: A researcher from America's highly rated medical school, the Johns Hopkins University in Baltimore, has been found guilty of using Indians as human guinea pigs in the now well-publicised illegal cancer drug trials at the Regional Cancer Center (RCC), Thiruvananthapuram.

An internal investigation by JHU has found that its faculty member ''tested experimental cancer drugs on patients in India without required federal or university approvals and without adequate preliminary tests in animals''.

Though the official release from JHU does not identify the 'sanctioned researcher', it is widely known that biologist Ru Chih C. Huang of its school of arts and sciences was collaborating with RCC director Dr. M. Krishnan Nair to test an un-approved experimental cancer drug that had been smuggled into India.

The drug trial was being funded through private sources which had already invested $2.5 million in the development of the experimental drug was set to raise its investment to about $50 million shortly. A central committee appointed by Union health minister C P Thakur in mid-September - and well before the American enquiry report was made public - had also found irregularities in this particular drug trial.

It had suspended all human trials at RCC for six months and asked for a show cause notice to RCC on why further action should not be taken. Reacting to the report, Thakur said the government would take severe action against all those proved guilty. ''It is a human right violation since it may be injurious to health and after investigations we will ask for very severe action against the guilty.''

The Americans have ''barred the scientist from serving as principal investigator on any future research involving human subjects'', among other other oversight requirements and limitations imposed on the scientist's work.

And, taking no chances, the university is also reporting the results of the damning investigation to the U.S. Food and Drug Administration. JHU has been under fire ever since this summer, when a healthy volunteer died while participating in drug trials in America. The investigation involved a study of two experimental cancer drugs conducted by the Hopkins scientist, as principal investigator, and Indian collaborators.

The trial at the RCC, involving 26 oral cancer patients, ran from November 1999 to April 2000. The drug in question is M4N, a methylated extract of the wild American bush creosote. Coming down severely on Dr Huang, the Johns Hopkins faculty committee found her ''negligent for failing to submit a proposal'' for the clinical trial to a Johns Hopkins University Institutional Review Board. Under university policy and federally mandated procedures, faculty experiments involving human subjects must have prior IRB approval, whether conducted in the United States or abroad.

What is worse, the report said, is that ''the trial did not meet Johns Hopkins standards for research with human subjects''. For example, the committee found there was inadequate safety testing of the drugs in animals before they were injected into human patients. The committee also said that consent forms used to recruit patients for the study were inadequate.

In fact Dr. V. N. Bhattathiri, the faculty member from RCC who blew the whistle on the controversy, had noted in front of the Kerala human rights commission that patients knowing only Tamil were made to sign consent forms drafted in Malayalam.

What might be a saving grace for both the Indian and American collaborators is that the committee said it found no evidence that any patient had been harmed or that any patient's conventional treatment was delayed by the clinical trial.

The committee report also criticized the university's initial handling of the case. It said that an inquiry should have begun in March 2001, when the university - which had earlier been aware of the 1999-2000 trial - first learned that the scientist had run it without university IRB approval.

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