Four gastric cancer patients undergoing chemotherapy died two years ago at the CHL-Apollo Hospital in Indore after a drug trial was conducted on them, the MP government admitted in the assembly last week.
This came to light after Congress MLA Pratap Grewal questioned the manner in which drug trial practices in private hospitals were done.
MP health minister Mahendra Hardia in a written reply admitted to the deaths in the assembly on March 17.
The information provided by the health ministry is that of the six patients who were to undergo the trial, only one could complete it. One discontinued and the remaining four died during the trial. The trial was initiated in May 2008 and the deaths occurred in 2008-09.
Grewal told Hindustan Times: “There should be re-investigation into the matter to find out the real cause of the deaths.”
The sponsor of the trial, the Thrombosis Research Institute, London, was studying the use of Enoxaparin, a drug already being marketed and is known to prevent and treat deep-vein thrombosis or pulmonary embolism (blockage of the main artery of the lungs or their branches).
However, this study aimed at finding the effect of Enoxaparin on patients undergoing chemotherapy.
“The deaths occurred either due to organ failure or because of the patients' condition as they were in the age group 55-65 and were terminally ill,” said the CHL-Apollo Hospital’s Dr Ashvin Rangole, who conducted the trials.
The deaths had been documented in the study, but there was nothing to prove that they occurred due to the trial, Rangole said.
The Drug Controller General of India and the MP Medical Council are investigating the reported cases of allegedly unethical drug trials in the city.