Over 88 per cent of the clinical trials conducted on children are proving to be fatal across India. The Ethics Committee or Institutional Review Boards are not involved in assessment of the health condition of paediatric subjects selected for the trial, according to a section of doctors in the government hospitals.
Even doctors at hospitals where the trials are conducted do not take adequate responsibility to ensure that these child subjects undergo proper medical check ups and diagnosis before they go in for the study. Many a time, the child is extremely weak or serious when he or she is pulled in for the trial.
According to the latest estimates, of the current 703 trials carried out in India 14 percent constitute paediatric studies for drugs to treat fever, pneumonia, Crohn disease, respiratory infections, diarrhoea, viral hepatitis, heart disease, tumours, neurology disorders, to name a few. The world's top ten global pharma majors are currently carrying out the largest number of clinical trials in India which include Wyeth, GSK, Pfizer, Merck and sanofi-aventis. The drugs include vaccines, oral drugs and inhalers.
"Attractive payments to research subjects, poor patient consent practices because of illiterate parents and easy availability of paediatric cases manifesting varied diseases make developing countries including India a much sought-after destination for conduct of clinical trials. Almost 90 percent of the studies are for multinational drug companies who are only keen to get an Indian report about the drug safety. The global pharma majors are also known to offer attractive payments to the doctors who conduct the trial which is passed on as cash incentives to the poor parents of sick children who are coaxed into the trial because the drug is free and at times they are reassured that there could a be possibility for recovery.
Hospitals in India are proving to be ideal to recruit patients at a faster pace, pointed out sources. Children are from uneducated parents or destitute kids. There are instances of unethical and illegal trials. Many deaths reported are attributed to adverse drug reactions after these trials which go unreported. The fatal cases occur due to serious adverse drug reactions. Death certificates indicate cause of death as natural and resulting out of a serious brain fever or a sudden infection which the child has acquired. There is absolutely no mention about the fact that the sick child was part of a paediatric clinical trial, stated sources.
"Trials in children are complex and fraught with risk," said Dr Sandhya Ravi, chief of Clinical Services, Lotus Labs and surgical oncologist. "Several factors must be considered before deciding to conduct a clinical trial in children. These include distribution of the disease in the paediatric population, severity of the disease, availability of alternative therapy, safety/efficacy versus toxicity ratio and practicality of study conducted," she added.
According to Shekhar Gupta, COO, D2L Pharma Research Solutions, the clinical research industry is certainly facing challenges from time to time on safety issues which include paediatric human studies. However these can be overcome by combined efforts from the industry and the Drugs Control General of India (DCGI). Deaths of paediatrics during a clinical trial need to be thoroughly evaluated for setting good standards for human studies in India."