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Drug trial sparks controversy
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.
Dr Reddy's Lab (DRL) in Hyderabad originally developed the drug in question, code named NN622. After carrying out preliminary animal toxicology studies, DRL sold the molecule to NovoNordisk in August 1998 for an undisclosed amount for further development and commercialisation. To allay fears in those who participated in the abortive trial, both 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".
In a telephone interview Ashvini Kumar, the drug controller general of India said the trial was done with approval from his office but refused to elaborate how permission was given for the large scale (phase-3) trial of the drug before obtaining data on its potential to cause cancer in animals.
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".
Senior officials of DRL were unavailable for comment. Its public relations officer told reporters 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, the names of investigators and if the drug was injected or swallowed".
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 says. (Agencies) Published on 13th August, 2002
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Copyright
2008, Chennai Interactive
Business Services (P) Ltd. |
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Hundreds of Indian diabetics are hapless participants in a controversial clinical trial by a European pharmaceutical company with a drug that has been subsequently found to cause cancer in rats and mice.
Pushpa Bharagava, a leading biomedical researcher in Hyderabad and former president of the Society for Scientific Values said he was surprised the drug was given to patients before knowing its full effects on animals. "It is unethical. It should not have been done."
While establishing that the real risk will take time, the Health Ministry has got itself into a controversy by permitting large scale (phase-3) trial of a new drug before getting complete toxicological data on animals including the drug's potential to cause cancer.
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 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".
NovoNordisk was more forthcoming. In a July 22 press release, it said the company had conducted clinical trials on 2,500 persons in 32 countries including 42 in Denmark. It, however, declined to divulge the names of other countries or whether most participants belonged to developed countries or the third world.
