Indian researchers accused of violating ethical guidelines
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《英国医生杂志》
Medical experts in India have accused government doctors of violating national guidelines on clinical ethics by treating patients in Mumbai with a new and unproved treatment developed abroad without insisting on parallel studies outside India. Wary of India抯 attractiveness as a site for clinical trials, the Indian government has maintained a policy of rejecting clinical trials of unproved treatments developed outside India when they are carried out only on Indian patients.
But doctors at the Institute of Immunohaematology, a centre of the Indian Council of Medical Research, used a stem cell therapy developed by a biotechnology firm based in Dublin and London to treat four patients with aplastic anaemia at Mumbai抯 King Edward Memorial Hospital last August.
It was claimed that the treatment, which used a proprietary "reverse differentiation" technology developed by TriStem Corporation, would transform peripheral white blood cells into pluripotent stem cells. TriStem抯 chief scientist, Dr Ilham Saleh Abuljadayel, took white blood cells from each patient and returned "transformed" cells for infusion into the patients.
The hospital抯 ethics committee suspended the study after it discovered that Dr Abuljadayel had contacted the patients and posted details of the study and the patients?photographs on TriStem抯 website. One of the four patients died in December from a respiratory infection that, hospital doctors said, was a complication of aplastic anaemia and not the result of the treatment.
The Indian Council of Medical Research has said that the study had been approved by its own expert committee as well as the hospital抯 ethics committee and had patients?consent. But experts say that the study has exposed "loopholes" in existing approval mechanisms.
"An institution wishing to conduct a study can抰 itself be the judge of whether to do it at all," said Dr Chandra Gulhati, editor of the Monthly Index of Medical Specialties India and an expert on clinical trials. "The council抯 committee approved the study for its own scientists."
Critics of the council抯 action also point out that the Indian government has a policy of rejecting clinical trials of new, experimental treatments developed abroad when they are not part of a multicentre study and are carried out exclusively on Indian patients.
Eight years ago, the council had itself declined to fund a study in India of fetal tissue transplantation for an eye disease under a protocol developed at a US university on the grounds that a parallel trial had not been done in the United States (BMJ 1997:314:165).
"Aplastic anaemia is not a particularly Indian disease, and there should have been patients outside India on whom this could have been tried," said Dr Samiran Nundy, editor of the Indian Journal of Medical Ethics. "Did our committees ask this question?"
Council doctors say treatment for aplastic anaemia in India is "unsatisfactory and toxic" and patients with this disease face the prospect of "steady decline and death within six to eight months."
The Institute of Immunohaematology抯 director, Dipika Mohanty, said that before the clinical study the institute had conducted animal tests to establish the safety of the transformed cells.
"We used the patients?own modified cells," he said. However, experts on regulatory affairs argue that stem cells from reverse differentiation should be deemed as "bioengineered" entities and should have been approved by India抯 advisory committee on genetic engineering.(New Delhi Ganapati Mudur)
But doctors at the Institute of Immunohaematology, a centre of the Indian Council of Medical Research, used a stem cell therapy developed by a biotechnology firm based in Dublin and London to treat four patients with aplastic anaemia at Mumbai抯 King Edward Memorial Hospital last August.
It was claimed that the treatment, which used a proprietary "reverse differentiation" technology developed by TriStem Corporation, would transform peripheral white blood cells into pluripotent stem cells. TriStem抯 chief scientist, Dr Ilham Saleh Abuljadayel, took white blood cells from each patient and returned "transformed" cells for infusion into the patients.
The hospital抯 ethics committee suspended the study after it discovered that Dr Abuljadayel had contacted the patients and posted details of the study and the patients?photographs on TriStem抯 website. One of the four patients died in December from a respiratory infection that, hospital doctors said, was a complication of aplastic anaemia and not the result of the treatment.
The Indian Council of Medical Research has said that the study had been approved by its own expert committee as well as the hospital抯 ethics committee and had patients?consent. But experts say that the study has exposed "loopholes" in existing approval mechanisms.
"An institution wishing to conduct a study can抰 itself be the judge of whether to do it at all," said Dr Chandra Gulhati, editor of the Monthly Index of Medical Specialties India and an expert on clinical trials. "The council抯 committee approved the study for its own scientists."
Critics of the council抯 action also point out that the Indian government has a policy of rejecting clinical trials of new, experimental treatments developed abroad when they are not part of a multicentre study and are carried out exclusively on Indian patients.
Eight years ago, the council had itself declined to fund a study in India of fetal tissue transplantation for an eye disease under a protocol developed at a US university on the grounds that a parallel trial had not been done in the United States (BMJ 1997:314:165).
"Aplastic anaemia is not a particularly Indian disease, and there should have been patients outside India on whom this could have been tried," said Dr Samiran Nundy, editor of the Indian Journal of Medical Ethics. "Did our committees ask this question?"
Council doctors say treatment for aplastic anaemia in India is "unsatisfactory and toxic" and patients with this disease face the prospect of "steady decline and death within six to eight months."
The Institute of Immunohaematology抯 director, Dipika Mohanty, said that before the clinical study the institute had conducted animal tests to establish the safety of the transformed cells.
"We used the patients?own modified cells," he said. However, experts on regulatory affairs argue that stem cells from reverse differentiation should be deemed as "bioengineered" entities and should have been approved by India抯 advisory committee on genetic engineering.(New Delhi Ganapati Mudur)