http://bmj.com/cgi/content/full/323/7323/1204/b
BMJ 2001;323:1204 ( 24 November )
News
Johns Hopkins admits scientist used Indian patients as guinea pigs
Ganapati Mudur
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.
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More Whistle Blowers Needed !
Prof K.R. Sethuraman. MD, PGDHE.,,
Professor of Medicine , JIPMER, Pondicherry, India
bmj.com, 22 Nov 2001 [Response]
Indian Patients as Guinea pigs.
Dr.MS
Basharuthulla,MD.,FACP,FRCP.Ire,FRCP.Glasg., Consultant Physician &
Cardiologist/Clinical Tutor , Adan Hospital Kuwait
bmj.com, 23 Nov 2001 [Response]
patients of third world- who cares
Dr Akhtar Sherin, Medical Officer
Khyber Teaching Hospital , Peshawar NWFP Pakistan
bmj.com, 23 Nov 2001 [Response]
Drug studies and tragedies in India
Romesh Khardori, MB.,MD.,FACP,
Professor-Director: Division of Endocrinology, Metabolism & Molecular
Medicine , Southern Illinois University School of Medicine;801 N.
Rutrledge; Springfield, IL 62794-9636
bmj.com, 24 Nov 2001 [Response]
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