the Indian Council of Medical Research (icmr), the custodian of medical ethics in the country , is embroiled in a controversy concerning clinical trials on human beings. The Institute of Immunohaematology (iih), Mumbai, which is under icmr, seems to have flouted basic ethics while using an untested technology in its trial on four patients suffering aplastic anaemia, a condition that prevents the bone marrow from producing blood cell components. iih collaborated with a little known British biomedical company, TriStem Corporation (tsc), in the trial. Although it now blames tsc for all the wrongs, a close look at the incident raises serious questions about the way it went about conducting the trial.
The promise iih carried out the trial at King Edward Medical Hospital (kemh) , using a novel therapeutic approach "retrodifferentiation' developed by tsc. Retrodifferentiation is a technique that allows creation of stem cells from the bone marrow. Stem cells are a class of wonder cells which, given the right signal, can turn into different cells in the human body. tsc's earlier laboratory studies had shown that the technique could effectively treat leukaemia cells. But though it looked promising, it wasn't tested on humans before this study.
One advantage of this technique is that as it produces stem cells from bone marrow, it doesn't involve the ethical issue of harvesting them from human embryos. It is also not toxic or expensive like the other treatments available.
The blunder tsc had approached icmr in 2003 to conduct the trials. Though icmr officials are vague about how the collaboration came about, tsc's chief scientific officer Ilham Abuljadayel told Down To Earth: "We were invited by a Chandigarh-based medical consultancy firm gg Haemhealth Technologies Private Limited (gghtpl) to conduct trials in India.' It is surprising how gghtpl came to acquire such importance. Experts believe it acted as a go-between in the collaboration. "Investigations reveal that a triangular relationship was somehow established between London-based tsc, an unheard of gghtpl and the icmr to undertake the study in gross violation of ethical guidelines for biomedical research,' said the journal Monthly Index of Medical Specialities.
The proposal for the trial was approved by an icmr expert group on April 20, 2004, after studying in vitro and experimental studies conducted by iih. But it is not clear why these studies weren't subjected to peer-review before the trials, as is the usual practice.
Worse followed The trial began in August 2004. It was conducted with Dipika Mohanty, iih director, as the principal investigator and Farha Jijina, haematology professor at kemh, as the co-investigator. Abuljadayel was "allowed to perform the laboratory procedure in the peripheral blood cell obtained from the patients and hand over the
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