The controversy surrounding the suspension of clinical trials on the diabetic drug, DRF-2725 (NN622), by Novo Nordisk has taken a new turn with reports of hundreds of Indian diabetic patients becoming hapless participants in the Swedish pharmaceutical company's clinical trials.
The drug, ragaglitazar, was developed by Dr Reddy's Laboratories, which had out-licensed the dual-acting insulin sensitizer for type-II diabetes to Novo Nordisk in August 1998. However Nordisk had suspended the Phase III clinical trial on the drug on July 22, 2002, saying it had discovered bladder tumours in some rats and mice, which had been administered the drug.
Pushpa M Bhargav, biometical researcher in Hyderabad and former president of the Society of Scientific Values, said he was surprised the drug was given to patients before knowing its full effects on animals, "It is unethical and should not have been done," he is reported to have told the PTI. Reacting to the PTI report, Dr.Reddy's said, "Whatever has to be clarified on the issue has been done by Novo Nordisk and we are not part of the trials."
However, late on Monday night the company issued a clarification. It reads: "The PTI news items suggests that appropriate carcinogenecity studies were not conducted prior to the commencement of trials in humans. This is wholly untrue. All the prescribed regulatory toxicology studies were rigorously conducted and adhered to. Novo Nordisk conducted long-term toxicology studies apart from the regulatory toxicology studies. It was in these long-term toxicological studies that several rats were observed to have developed urine bladder tumours in February 2002. It is a known fact that the development of such tumours in rats is species-specific and does not have any implications for humans."
"Prior to the initiation of clinical trials, Novo Nordisk had performed genotoxic studies with NN622 (DRF-2725). All genotoxic studies were negative, which means there is very strong evidence that NN 622 is not a genotoxic compound," it said. A genotoxic carcinogen is a compound that causes cancer by damaging genetic material.
Bhargava said, " Dr Reddy's cannot be blamed because it was upto Novo Nordisk to provide all the pre-clinical data on NN 622 to the volunteers."
Novo Nordisk earlier said it had conducted clinical trials on 2500 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 nations or the third world.
The company said, "It conducted 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 trials have nothing to worry about.