An RTI application filed by the NGO Uday Foundation led to the startling disclosure that around 49 babies had died after allegedly being administered drugs during clinical trials at India’s premier medical institution, the All-India Institute of Medical Sciences. AIIMS denies the charge saying the infants had succumbed to their illnesses

Taking serious note of a complaint about the death of 49 infants reportedly due to the use of drugs meant for adults during clinical trials, the National Human Rights Commission (NHRC) has issued a notice to the Union health ministry and the All-India Institute of Medical Sciences (AIIMS), where the trials were conducted, seeking a reply within four weeks. 

“This is a show-cause notice and we have sought comments from the secretary of the health ministry and the AIIMS director on a complaint filed with us,” said an NHRC official. 

The NGO, Uday Foundation, whose RTI query led to the startling disclosure earlier this month of clinical trial deaths at AIIMS, sought the NHRC’s intervention in the case following reports that adult drugs had been tried on babies at the premier medical institute. Reports also suggested that the babies involved mostly belonged to weaker sections of society. 

Rahul Verma of the NGO, in his petition to the NHRC, alleged violations of the right to life under Article 21 of the Constitution. “We are seeking the NHRC’s intervention because we have no faith in any internal inquiry by the institute,” Verma said. 

AIIMS, in response to a right to information (RTI) query, admitted that 49 babies had died during clinical trials over the past two-and-a-half years. AIIMS’s paediatrics department had conducted 42 sets of trials on 4,142 babies -- 2,728 of them below the age of one -- over two-and-a-half years since January 1, 2006. 

AIIMS authorities, however, say the deaths were not due to drugs used in the trials but resulted from the diseases suffered by the children. “We want to clarify that none of the deaths was due to the medication or interventions used in the clinical trials,” said Dr V K Paul, head of the paediatrics department. 

“Clinical research is the mandate of AIIMS clinicians. Novel therapies are examined keeping in mind the utmost safety of all patients. The research protocol undergoes intense scrutiny by the internationally-recognised Institute Ethics Committee. Written informed consent is taken (from parents and guardians),” Paul said. 

“Most of the 42 clinical trials have reported no deaths. The deaths are mainly due to inherent diseases and not due to the medicines used,” Paul added in answer to the RTI question. 

However, Verma maintains the babies were administered drugs not meant for them. “The drugs were given to children without any classification of age; they were, in fact, used as guinea pigs during the tests at India’s premier health institute,” he said.  

The findings have drawn AIIMS into the centre of a controversy, and questions are being raised as to why the hospital was given permission to try drugs on children. Accusations are also flying thick and fast about children from poor families being targeted because they are vulnerable. 

Meanwhile, the authorities at AIIMS has kept a stony silence on the details of the case although the NGO claims to have information that the drugs, which are on test primarily for adults suffering from hypertension in other parts of the world, had been tested on children below 16 years in India even though there was neither the permission nor the need for such tests to be done (as children rarely suffer from hypertension).  

Consumer activists and scientists have long been claiming that India is being used either as a dumping ground for banned medicines or as a testing ground for medicines that are yet to be introduced in the ‘civilised’ world. The government has failed to use its regulatory powers to curb such malpractice.  

In light of this latest incident, activists say if a premier government-controlled institute like AIIMS can allow such unethical and blatantly inhuman practices on research subjects, the research protocol being followed at other institutes can only be imagined.  

Source: DNA, September 1, 2008
       PTI, August 27, 2008
       IANS, August 27, 2008
       http://india.merinews.com, August 2008