Tuesday, Aug 13, 2002
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The participants, many of them believed to be from Hyderabad, had taken the drug for six to seven months before the Scandinavian firm NovoNordisk, on its own, suspended the trials last month for ethical reasons.
Pushpa Bhargava, a biomedical researcher in Hyderabad and former president of the Society for Scientific Values, said he was surprised that the drug was given to patients before knowing its full effects on animals. ``It is unethical. It should not have been done.''
The drug, code named NN622, was originally developed by Dr. Reddy's Lab (DRL) in Hyderabad. After carrying out preliminary animal toxicology studies, DRL sold the molecule to NovoNordisk in August 1998 for further development and commercialisation.
To allay fears in those who participated in the abortive trial, DRL and NovoNordisk claim that although the anti-diabetic drug caused ``bladder tumours in a number of rats and one mouse,'' any potential risk to trial participants is ``very small.''
While establishing the real risk will take time, the Health Ministry has got itself into a controversy by permiting large scale (phase-3) trial of a new drug before getting complete toxicological data on animals including the drug's potential to cause cancer.
The Drug Controller General of India, Ashvini Kumar, said the trial was done with approval from his office but refused to elaborate on how permission was given for the large scale trial.
While the Norwegian firm says it followed the ``international procedure,'' Indian guidelines insist that carcinogenicity study on animals must be completed prior to launching phase-3 trial of any new drug.
Says the Health Ministry's website: ``Acute and long- term toxicity studies in different species in animals, special toxicity studies including reproductive studies, mutagenicity and carcinogenicity are examined before considering grant of permission for clinical trial of new drugs in India.''
Corroborating this, a spokesman for the Indian Council of Medical Research said carcinogenic data on at least two species of animals is at present necessary before proceeding with phase-3 trial. ``We are now insisting that this data must be available even before starting phase-1 trial.''
The public relations officer of DRL said that his company was not directly responsible for the trial. He said due to confidentiality reasons he could not disclose ``where exactly the trial was done in India, the exact number of participants, names of investigators and if the drug was injected or swallowed.''
NovoNordisk was more forthcoming. In a July 22 press release, it said it had conducted clinical trials on 2,500 people in 32 countries including 42 in Denmark.
It, however, refused to divulge the names of other countries or whether most participants belonged to developed countries or the third world.
The release said the company ``conducted the trials in full compliance with all requirements for good clinical practice'' and is now trying to find out what caused the bladder tumours in animals.
If they were found to be specific for the rodent species, those who participated in the trial have nothing to worry about, the company said. PTI
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