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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PANOS PICTURES/LIBA TAYLOR
India would be an attractive testing ground for drugs