E-drug: Unethical anticancer drug trial India
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[Copied as fair use. HH]
BMJ 2001;323:299 (11 August 2001)
News - Indian doctors defend "unethical" anticancer drug trial
Ganapati Mudur, New Delhi.
Indian doctors, accused of having breached ethics in trials of a
candidate drug against cancer, have said that the study was done
with the consent of patients, hospital ethics panels, and
government officials.
India's health ministry and Johns Hopkins University in Baltimore,
Maryland, are investigating charges that doctors breached ethics
when they tested the drug, developed at Johns Hopkins, on Indian
patients with oral cancer. Johns Hopkins University is already at the
centre of concerns over its use of inhaled hexamethonium in trials
of drugs for asthma (see story below).
The investigation into the trials in India, announced last week,
comes after a doctor at the publicly funded Regional Cancer Centre
in Trivandrum, Kerala, alleged that his colleagues injected the drug
into at least 20 patients without the appropriate approval from
health authorities.
Dr V Narayan Bhattathiri, associate professor and head of clinical
radiobiology at the centre, complained to the State Human Rights
Commission that the study violated Indian health ministry guidelines
that drugs developed abroad should not be trialled exclusively on
Indian patients.
Doctors associated with the cancer trials have defended the study,
saying it was done with the informed consent of the patients and
approval from hospital ethics committees.
"The drug also did not harm any patient and it did not interfere with
standard therapy, whether surgery or radiation," Dr M Krishnan
Nair, director of the centre, told the BMJ. He said approval for the
study was obtained through "discussions" with the drugs
controller's office, and the patients had been informed that the drug
was experimental.
Johns Hopkins University has said that at no time had any of its
institutional review boards approved the collaborative study,
conducted between November 1999 and April 2000. A faculty
member at the university who initiated the study is now under
investigation.
The Kerala centre initiated the study after a biology professor at
Johns Hopkins, Ru Chih Huang, approached it for clinical trials of a
synthetic derivative of the plant product nordihydroguaiaretic acid.
Her laboratory had earlier shown that this derivative, M4N (a
tetramethyl), could arrest the growth of artificially induced mouse
tumours.
"When it was time to test the drug on humans, they moved their
experiments to India," Bhattathiri said.
The controversy has sparked concerns that India is emerging as an
attractive testing ground for experimental drugs. "India has a vast
pool of patients, qualified doctors, and good hospitals that make it
an attractive site," says Ashwini Kumar, India's chief drugs
controller.
Earlier this year health authorities began asking how 16 patients in
a private hospital in New Delhi received vascular endothilial growth
factor, an experimental treatment for coronary artery disease that
was developed by doctors in the United States.
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