49 babies died during clinical trials at AIIMS in last 30 months
Aug 17, 2008 - 11:35:21 AM
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The reply to another query partly answered this question, saying that the consent form the parents have to sign 'is read out by the treating physician for parents who are not able to read themselves'.
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By Mayank Aggarwal,
[RxPG]
New Delhi, Aug 17 - As many as 49 babies have died during clinical trials at the premier All India Institute of Medical Sciences - during the last two-and-a-half years, the reply to a Right to Information - query has revealed.
The AIIMS paediatrics department conducted 42 sets of trials on 4,142 babies - 2,728 of them below the age of one - since Jan 1, 2006.
Forty-nine babies died during the trials. AIIMS says the deaths amounted to a 1.18 percent mortality rate, according to its reply to the RTI query.
'A total of 49 deaths corresponding to 1.18 percent mortality among the enrolled patients were recorded in the studies. These include deaths both in the control and intervention groups, as per the designs of individual studies,' the reply says.
The reasons for the babies' deaths, their ages or their gender are not contained in the reply - since these were not specifically asked by the applicant, Rahul Verma, founder of NGO Uday Foundation for Congenital Defects and Rare Blood Groups.
Verma, in fact, had filed separate queries with the same set of questions with the paediatrics department and the paediatrics surgery department. He says he received an unsatisfactory reply from the latter and is going to file an appeal in the case.
Clinical trials are research studies that test how well new medical formulations work on people. Each study attempts to find better ways to prevent, screen for, diagnose, and treat a disease.
If carefully conducted, clinical trials are the safest and fastest way of finding treatments that work.
In reply to a query on who the five top funding agencies for the trials were, AIIMS named the institute itself, the Indian Council of Medical Research -, the Department of Biotechnology -, the World Health Organisation - and the Johns Hopkins Bloomberg School of Public Health in the US.
Five foreign-manufactured medicines were tested during the trials. They were:
* Zinc tablets for treating Zinc deficiency and serving as a nutritional supplement,
* Olmesartan and Valsartan for treating blood pressure related problems,
* Rituximab for treating chronic focal encephalitis, a condition affecting the brain, and
* Gene-activated human glucocerebrosidase - for treating Gaucher disease that affects the liver.
In reply to another query, AIIMS said that before conducting the trials, it had taken clearance from its own Ethics Committee, the Health Ministry Steering Committee - on ethics and the National Ethics Committees of ICMR and DBT.
Verma, however, maintained that there were legal and ethical lacunae in the system as permissions had to be sought from different agencies depending on the nature of the trials.
'There needs to be a nodal agency, like the Care Prevention Control for Experimental Animals -, whose permission has to be sought before using animals as guinea pigs,' he contended.
According to Verma, 'the unquestionable ease with which clinical trials can be conducted on human beings in India makes international agencies first test their products on the Indian population.'
'This prompted me to find out the details and the ethical procedures involved if any.
'The fact that of the 4,142 babies on whom clinical trials were conducted, 2,728 were under one year of age is scary,' Verma maintained.
In reply to a query on whether the babies on whom the trials were conducted belonged to the lower socio-economic strata of society, AIIMS said: 'Children eligible for clinical studies conducted in department represents a mix of those attending the out-patient and in-patient services.
'No studies selectively target children belonging to low socio-economic status -. The eligibility is based on the aims of respective studies,' the reply stated.
The institute, however, was silent to a query on the number of babies from families living below the poverty line who were part of the trials.
The reply to another query partly answered this question, saying that the consent form the parents have to sign 'is read out by the treating physician for parents who are not able to read themselves'.
'The question is: If the parents can't read or write, do you really expect them to understand the implications of these trials?' Verma wondered.
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