Bangalore: The death of 49 babies in clinical trials at the All India Institute of Medical Sciences (AIIMS) in New Delhi may have opened a Pandora’s box as two of the trial drugs have never been tried on patients below 18 years, an expert said.
How many of the children died because of the trial drugs will be known only when an enquiry committee submits its report this month, but doctors have already raised questions of ethics.
The AIIMS Paediatrics Department conducted 42 sets of trials on 4,142 babies – 2,728 of them below the age of one – since January 1, 2006.
Two of the trial drugs – olmesartan and valsartan, meant for reducing blood pressure – have never been tried on patients below the age of 18 years, said Chandra M Gulhati, editor of the Monthly Index of Medical Specialties and a keen observer of clinical trials in India. “The sponsors are trying to determine their efficacy and safety on children and adolescents” by conducting the trials in India at AIIMS, he said.
Gulhati asked: “Is hypertension in this age group (1-16 years) a problem in India? If yes, what is the incidence and prevalence? If it is not a major problem, why conduct a trial in India and put children at risk without any benefit?”
According to the US Food and Drugs Administration, the “pharmacokinetics” (what the body does to the drug) of valsartan has not been investigated in patients below 18 years of age.
Studies on another trial drug – rituximab for treating a type of cancer – have so far been done only on adult patients.
Gulhati said the phase III clinical trials are normally conducted as pre-approval requirement for marketing a new drug. “If the company has not applied for marketing approval to use the drug on children, why were phase III trials permitted?”