Deadly Clinical Trials on Infants by A.I.I.M.S.
‘Heart bleeds! Eyes shed tears of blood!’ – These are the impotent reactions of Armchair Critic and Action less Wood like me on reading a news item of ‘Death of 49 infants due to outsourced clinical trials at A.I.I.M.S.’ I am ashamed of myself in just simply airing the agonies in an Editorial!
Bare Facts of the tragic episode are these:
· 139 new clinical trials were outsourced to India. Cost of conducting clinical trials in India is less – between 20-60% as compared to trials in industrialized countries.
· This clinical market trial was being undertaken for the past 2 ½ years. 4142 babies were undergone these trials. Of 4142 babies, 2728 were below the age of one. The parents of all these babies were poor and illiterates. They had been picked up by the hospital attending the outpatients and inpatients services. This itself goes to prove that the doctors would be more prone to catch the infants of these hapless parents rather than treating them for their ailments.
· Five foreign manufactured medicines were tested during the trials and the medicines contained zinc, which is harmful to liver. 42 sets of trials on these infants were conducted by A.I.I.M.S.
· A.I.I.M.S. declares that they got clearance from (1) Its own Ethics Committee (2) Health Ministry Steering Committee (HMSC) on ethics (3) National Ethics Committee of ICMR and DBT.
· Consent forms were obtained from all the parents of the babies agreeing to be part of the trial. It is a different matter, if the parents are poor and illiterates. A.I.I.M.S. is all worried about the foreign money that they will be getting for this heinous crime of clinical trial market.
The worst part of the episode had been unveiled when our honorable Health Minister Mr.Anbumani Ramadoss had said: ‘The clinical trial market is increasing in India. Hence we have stipulated a separate provision in the Bill to ensure that best practices are followed while conducting such trials. Soon, we will have a law.’
He had gone one step further, when he explained: ‘A.I.I.M.S. is a renowned research institution. The children must have died because they were already very ill. The controversy could have been avoided if the institute had taken care to draft better its response to a RTI query inquiring about deaths of children during clinical trials.’
I am posing these questions to the minister:
1.The duty of the doctors should be to save the children. All the more, how could the already sick children be put to the clinical trails? Who was responsible for the sufferings that might have been undergone by these helpless infants during the trials? How did the doctors become heartless, ethic less and mindless?
2. How could the Minister advise the A.I.I.M.S. to draft the reply in such a way as to hide the facts in order to avoid controversy?
‘Scrap this atrocious experiment of Clinical trails murdering poor kids being undertaken for the sake of foreign exchange’ – Let us raise our banner of revolt in all our sincerities.
Let the poor soul of 49 infants rest in peace. Let these angel souls – though poor, but powerful, haunt those doctors and the minister, till they stop this crime forthwith.
One of my friends' reactions to this horrid episode are heart consoling: “On reading the episode, I am of the opinion that All India Medical Council should be renamed as All India Murdering Council.“
Bare Facts of the tragic episode are these:
· 139 new clinical trials were outsourced to India. Cost of conducting clinical trials in India is less – between 20-60% as compared to trials in industrialized countries.
· This clinical market trial was being undertaken for the past 2 ½ years. 4142 babies were undergone these trials. Of 4142 babies, 2728 were below the age of one. The parents of all these babies were poor and illiterates. They had been picked up by the hospital attending the outpatients and inpatients services. This itself goes to prove that the doctors would be more prone to catch the infants of these hapless parents rather than treating them for their ailments.
· Five foreign manufactured medicines were tested during the trials and the medicines contained zinc, which is harmful to liver. 42 sets of trials on these infants were conducted by A.I.I.M.S.
· A.I.I.M.S. declares that they got clearance from (1) Its own Ethics Committee (2) Health Ministry Steering Committee (HMSC) on ethics (3) National Ethics Committee of ICMR and DBT.
· Consent forms were obtained from all the parents of the babies agreeing to be part of the trial. It is a different matter, if the parents are poor and illiterates. A.I.I.M.S. is all worried about the foreign money that they will be getting for this heinous crime of clinical trial market.
The worst part of the episode had been unveiled when our honorable Health Minister Mr.Anbumani Ramadoss had said: ‘The clinical trial market is increasing in India. Hence we have stipulated a separate provision in the Bill to ensure that best practices are followed while conducting such trials. Soon, we will have a law.’
He had gone one step further, when he explained: ‘A.I.I.M.S. is a renowned research institution. The children must have died because they were already very ill. The controversy could have been avoided if the institute had taken care to draft better its response to a RTI query inquiring about deaths of children during clinical trials.’
I am posing these questions to the minister:
1.The duty of the doctors should be to save the children. All the more, how could the already sick children be put to the clinical trails? Who was responsible for the sufferings that might have been undergone by these helpless infants during the trials? How did the doctors become heartless, ethic less and mindless?
2. How could the Minister advise the A.I.I.M.S. to draft the reply in such a way as to hide the facts in order to avoid controversy?
‘Scrap this atrocious experiment of Clinical trails murdering poor kids being undertaken for the sake of foreign exchange’ – Let us raise our banner of revolt in all our sincerities.
Let the poor soul of 49 infants rest in peace. Let these angel souls – though poor, but powerful, haunt those doctors and the minister, till they stop this crime forthwith.
One of my friends' reactions to this horrid episode are heart consoling: “On reading the episode, I am of the opinion that All India Medical Council should be renamed as All India Murdering Council.“
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