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.