VISAKHAPATNAM: Human Resource Development Minister Ganta Srinivasa Rao on Monday said a committee would be constituted to investigate the allegation that clinical trials were conducted in King George Hospital (KGH).
A few months ago, the Central Drugs Standard Control Organisation (CDSCO) revealed that unethical drug trials were carried on children aged between 9 and 12 years in the paediatric department and issued notices to the hospital and the head of the wing, seeking an explanation and answers to certain queries.
Taking the issue seriously, the Institutional Ethics Committee (IEC) of the hospital, which was formed two months ago, started questioning the AMC and KGH authorities and the paediatric department officials for full information regarding the issue. Having not been satisfied with the information given by the officials, IEC had several doubts over the clinical trials in the hospital. Against this background, the CDSCO objections, notices and other developments came to light recently.
According to the CDSCO, the KGH paediatric department conducted ‘drug trials’ on around 300 patients instead of 100 subjects as per the permission was given to them. Questions were also raised on precautions they had taken during the new drug administration, whether the prior consent of the individuals was taken, the amount they spent on each patient who underwent drug trial, periodic health check-up and maintenance of records regarding these tests.
After the death of a patient, Rama Rao, the Ethics Committee found that though permission was taken for trials on a specified number of people, the hospital conducted trials beyond that number. It was alleged that some children were also administered drugs without taking the signature of parents or guardians. Not satisfied with the answers given by KGH and AMC, IEC informed the Principal Secretary (Health) and demanded the intervention of the government in the issue.
On Monday, reacting to the IEC’s demand for government intervention, Srinivasa Rao, addressing media at Andhra Medical College, said a committee comprising outside experts would be constituted and it would be asked to submit a report within a month.
The minister said they observed a few violations and there were no records of the trials. The expert committee will look into the trials conducted, a total number of people who underwent these tests, and how many children beyond the permitted number were subjected to the clinical trials. The scope of inquiry will include checking of the records of previous five years on all the drug trials conducted in the hospital.
Admitting the fact that there are no records of many trials, AMC principal PV Sudhakar said, “The records stored in the surgery department were damaged during Hudhud cyclone. ” After recent allegations made by drug control authorities that the KGH had conducted trials on more than 300 patients against the permitted 100, they had sent a report to the Principal Secretary, Health, on it.
Meanwhile, the postmortem report of Rama Rao, who died on May 17, said that the death was ‘natural’ and due to bilateral bronchopneumonia. A native of Vizianagaram, he worked in a private firm here and enrolled for drug trial. He was treated for kidney disease. On the inordinate delay in Rama Rao’s postmortem report, KGH Superintendent G Arjuna blamed the forensic department.
Issue blown out of proportion: Superintendent
KGH Superintendent G Arjuna said that 18 clinical trials are being conducted in various departments at present. “These are not drug trials, but clinical trials. Clinical trials are done for medicine which is already being used and the medicine is used on other patients in different systems. It is not a new medicine. This is being done at other centres also. Drug trials are being done on a new medicine on patients. For lack of proper awareness among the members of the ethics committee, the issue has been blown out of proportion,” said the KGH Superintendent.