Bhopal : Victims of the Bhopal gas tragedy may have got just a pittance as compensation. But Doctors at Bhopal Memorial Hospital and Research Centre (BMHRC) made a killing trying out drugs on the patients.
Documents reveal that BMHRC collected nearly Rs 1 lakh per patient for enrolling and testing a foreign drug ‘illegally’ on the victims.
According to the documents, Wyeth Research — a US-based pharma behemoth — paid Rs 90,488 per patient to doctors at BMHRC for studying the safety and efficacy of their drug tigecycline on hospitalised patients with complicated stomach infection.
Out of the 34 patients enrolled by the BMHRC doctors for the clinical trial, 32 were gas victims. Two patients died of adverse events during the study conducted in 2006, documents reveal.
According to the Wyeth Research’s budget and payment schedule, it was agreed that the doctor (investigator) will receive Rs 90,488 per completed patient for the study.
The per patient amount was intended to cover the study-related costs incurred by the hospital — BMHRC — including costs related to patient visits (day care cost, stay), costs for study-related communications, salaries of staff and investigator and institute service charges and overheads. The monitory transactions were made through the contract research organization (CRO) – Quintiles.
Though the BMHRC officials said they had taken the consent of patients subjected to the trials, they failed to provide substantial evidence of the consents to a team of Central Drugs Standard Control Organisation (CDSCO), which is probing the issue.
The CDSCO team in its report to the Directorate General of Health Services (DGCI) said that the patients were compensated neither for their time, travel, nor for any expense incurred in connection with participation in the study.
The Indian Good Clinical Practice (GCP) guidelines clearly say that subjects (patients used for trial) should be reimbursed for expenses incurred.
The GCP guidelines also prohibit use of patients from vulnerable groups for drug trials.
“Instead of giving warning or advisories, the DGCI should immediately cancel the license of the doctors who subjected poor gas victims to illegal drug trials for own monitory benefits. It’s a criminal act,” says Bhopal Group for Information and Action’s Rachna Dingra.
“Three gas victims died during the course of this trial. The families of the gas victims who died did not receive no compensation. And how would they claim the compensation when they have no information about the drugs that were tested on the patient?” Dhingra said quoting documents she obtained from the office of the DCGI.
Source: Daily Bhaskar