http://bmj.com/cgi/content/full/323/7308/299
BMJ 2001;323:299 ( 11 August )
News
Indian doctors defend "unethical" anticancer drug trial
Ganapati Mudur
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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© BMJ 2001
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