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 Reddys Labs (DRL), was tested on at least
   135 human beings at the Nizams 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. Reddys 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:
   [1]http://timesofindia.indiatimes.com/articleshow.asp?artid=[2]19049806

References

   1. http://timesofindia.indiatimes.com/articleshow.asp?artid=19049806
   2. http://timesofindia.indiatimes.com/articleshow.asp?artid=19049806