Dr Rat.

[Matthew X]

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’.
Related Stories:
http://timesofindia.indiatimes.com/articleshow.asp?artid=19049806
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