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Online edition of India's National Newspaper Friday, September 07, 2001 |
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'Panels delaying probe into RCC issue'
By Our Staff Reporter
THIRUVANANTHAPURAM, SEPT. 6. The committees probing the
controversial drug trials in the Regional Cancer Centre (RCC)
here were seeking to prolong the proceedings so that the issue
would fade away from public memory, the health researcher, Dr. C.
R. Soman, has charged.
He was speaking at a seminar on the topic, "RCC and drug
trials: are the people of the Third World guinea-pigs of
multinational companies?", organised by the Yuvajana Vedi here
today.
Dr. Soman said the real facts about the Johns Hopkins-linked
drug trails could be unearthed if answers could be found to
questions such as whether the tests were carried out on animals
and whether the patients, mostly illiterate, were told about the
tests.
He said the unethical drug trials carried out on 25 patients at
the RCC was a "criminal act" and those who conducted the test
would be held responsible if any of the patient who underwent the
test died.
Dr. Soman, who is also the chairman of the voluntary agency,
Health Action by People (HAP), said the public should exert
pressure on the authorities to bring out the truth.
According to the health researcher, it was clear from all
available documented information, including the RCC's official
press releases, that there were several claims by the RCC
authorities that failed to tally with the facts.
The trial was outside the ambit of the project cleared by the
RCC's ethical committee and the Drugs Controller General of
India's clearance.
Dr. Soman said the human trials of the two chemicals, M4N and
G4N, which were isolated at the Johns Hopkins University, were
carried out on 25 patients at the RCC between November 12, 1999
and April 8, 2000.
The tests were carried out on oral cancer patients awaiting
surgical treatment without testing the drug on animals and
without following the laid down norms in the country.
According to Dr. Soman, the biopsy samples taken from first four
patients were later taken to Johns Hopkins University from the
RCC.
According Dr. Soman, the RCC received Rs. 17 lakhs in the first
year and Rs. 23 lakhs for the study. The drug was brought to the
RCC without obtaining the mandatory licence from the Drugs
Controller General of India (DCGI).
It was when the Benares Hindu University and the JK Cancer
Institute asked for the licence for carrying out the study at the
two centres, that the licence from the DCGI was obtained in seven
days, he said.
Dr. Soman said large-scale drug trials were being clandestinely
carried out on the people of the Third World countries in order
to ascertain the real consequences of the medicines and the
effects on human subjects at low cost.
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