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Collections under which this article appears: International health Diabetes Adverse drug reactions

BMJ 2002;325:353 ( 17 August )

News

Researchers question ethics of diabetes drug trial

Ganapati Mudur, New Delhi

Indian scientists have questioned the ethics of clinical trials of a candidate drug for diabetes conducted by the European company Novo Nordisk in 32 countries, including India, before the drug was fully tested in animals.

Novo Nordisk suspended clinical trials of the new molecule ragaglitazar in July after it discovered that several rats and one mouse treated with the drug had developed urinary bladder tumours. The company said it was suspending the trials until the cause of the tumours had been determined. The drug had been discovered by an Indian company, Dr Reddy's Laboratories, and licensed to Novo Nordisk.

The clinical trials across Asia, Europe, the United States, and Latin America had been approved in each country, said Mike Rulis, a spokesperson for Novo Nordisk. He said short duration toxicity tests on animals had been completed before the human trials started.

For drugs that treat chronic conditions such as diabetes, it is permissible to conduct long duration toxicity tests on animals in parallel with human clinical trials, he said.

But a senior official of the Indian Council of Medical Research said that Indian regulations insist that results of toxicity studies on drugs for chronic diseases are available before phase III clinical trials begin. "We do not know on what basis the drug control agency here approved the trials," the official said.

The company said that US and European health authorities had not questioned the continuation of clinical trials when they were told of the tumours in the rats earlier this year. It was only when tumours were detected in a mouse, that the trials were suspended.

"It is unethical for human trials to run concurrently with chronic toxicity tests on animals," said Pushpa Bhargava, founder director of India's Centre for Cellular and Molecular Biology and member of the ethics panel at the Nizam Institute of Medical Sciences, Hyderabad.

"This may be justified for drugs against life threatening conditions like cancer for which no drug exists at all, but this is not the case for diabetes," he said.

He added there was suspicion that countries like India are favoured for trials that might not gain approval in developed countries. Last year, an Indian hospital admitted conducting unapproved trials of a new cancer drug developed in a US university (BMJ 2001;323:299)[Full Text].

© BMJ 2002
 

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Collections under which this article appears: International health Diabetes Adverse drug reactions

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