Diabetes drug prematurely tested on humans

TIMES NEWS NETWORK [ WEDNESDAY, AUGUST 14, 2002 12:04:59 PM ]
HYDERABAD: Ragaglitazar, the controversial dual-acting insulin sensitiser developed by Dr Reddy’s Labs (DRL), was tested on at least 135 human beings at the Nizam’s Institute of Medical Sciences (Nims) even before trials on rats and mice were completed.
The experts realised the dangerous side-effects of the drug only after Novo Nordisk, the Scandinavian company assigned to develop the medicine, stopped testing on July 22, after the experimental rats and mice began developing tumours and symptoms of cancer.
The tests of the drug at Nims continued for well over six months, sources in the hospital confirmed. The trials on human beings — phase-III of the drug test — were conducted under the supervision of the Diabetic School of the hospital. The sources insisted that trials conducted by them were approved by the Medical Council of India and the Drug Controller-General of India.
However, it is not known if any or all of the 135 human guinea pigs at Nims were informed that they were being administered a yet-to-be proven diabetes drug. It is also not clear if they were told that the drug was being simultaneously tested on rats and mice.
Dr. Reddy’s Labs, though, has disowned the phase-III trials, saying it had licensed the drug for further development to Novo Nordisk.
“Testing of yet-to-be proven and potentially dangerous drugs on human beings is common here. Our hospitals are places where patients take medicines administered to them without asking a question. And, in the course of a trial, if a patient dies, all the doctor does is change the dosage for the others and continue with the test,” a source said.
“This is not the first time that an unproven drug has been tested on human beings, sometimes perforce in the city,” the sources added. Meanwhile, government sources said they were unaware of the tests conducted by Nims and were at a loss to explain anything about the trial.
Ragaglitazar, codenamed DRF 2725 and NN662, was developed by DRL. After carrying out preliminary animal toxicology studies, DRL sold the drug to Novo in 1998 for further development and commercialisation.
To ally fears in those who participated in the abortive trial, both the Hyderabad-based laboratory and Novo Nordisk claim that though the anti-diabetes drug caused “bladder tumours in rats and in one mouse,” potential risk to the trial participants is ‘very small’.
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