Jun 04, 2010
The trial to compare two diabetic drugs is being carried out in 10 sites in India although it is well known that one of them increases the risk of heart attack. There is an urgent need to stop the unethical and inhuman trials which is putting hundreds of ill-informed patients at peril.
An "unethical" trial to compare two anti-diabetic drugs, one of which is known to increase the risk of heart failure and heart attack, is risking the lives of patients, said drug experts. They said the trial should be stopped immediately by the Drug Controller General of India.
The drugs rosilglitazone and pioglitazone are being compared at 10 sites in India - Bangalore, Karnal, Kottayam, Vijaywada, Mumbai, Nasik, Pune, Trichy, and two sites in Kochi - to see if rosiglitazone is associated with more risk for patients. The enrolment at Bangalore-based St John's Medical College has already begun.
The trial is proposed in some 170 sites across the world. Of late, those carrying out the trial are finding it difficult to recruit patients because of safety concerns. Two sites in the US recently withdrew from the trial on this count.
"It is most unethical and inhuman to administer a drug already known to be inferior to the comparator molecule. There is no justification to conduct the trial on Indian subjects by making them guinea pigs. It should be stopped," Dr C.M. Gulati, editor, Monthly Index of Medical Specialties, said.
It is now known that rosiglitazone is more likely than pioglitazone to induce heart attack by roughly 50 per cent, Gulati said. People participating in the trials in India are not even being given a true picture on the safety aspects of the drugs. The trial will put hundreds of ill-informed patients at risk.
In 2008, the American and the European Diabetes Associations had advised against using rosiglitazone in view of the safety data.
Doctors in the US have already switched from rosiglitazone to pioglitazone with four times as many prescriptions written for pioglitazone than for rosiglitazone in 2008.
In India, too prescriptions for rosiglitazone are shrinking by 2.8 per cent annually while pioglitazone are increasing by 17.9 per cent. Rosiglitazone sales are already 23 per cent lower than pioglitazone's sales.
"Trials have shown rosiglitazone causes excess risk of heart attack by 10-44 per cent. No study has shown any decreased risk of heart attack. Pioglitazone, in some studies, has shown decreased risk of heart attack by 10-15 per cent. Hence we have discontinued use of rosiglita rosiglitazone," Dr Anoop Misra, director, department of diabetes and metabolic disease at Fortis Hospital, said.
With other beneficial drugs such as metformin and exenatide available now, stopping the use of rosiglitazone is no longer a constraint.
"Such trials should not be carried out. It should be considered unethical," Misra said.
The US Food and Drug Administration in 2007 had asked GlaxoSmithKline to carry out the trial to know if rosiglitazone is more dangerous than pioglitazone.
Not much information was available on the two drugs in 2007.
However, since then, much data has been generated worldwide, Gulati said.
Rosiglitazone-induced heart failure also has an excess risk of death compared to pioglitazone.
Gulati said since enrolling people in such studies is difficult in western countries, sites in India and other developing countries such as Chile, Mexico, Colombia and Pakistan have been added by the company.
Officials in the Drug Controller General of India said rosiglitazone was under review.