New Delhi, Aug 26 (UNI) The All India Institute of Medical Sciences today said none of the 49 deaths of children during clinical trials at AIIMS were due to the treatment modalities under trial.
''The deaths in children were due to high risk and serious disease conditions that the children suffered from,''the AIIMS said in a statement.
In a release issued here, the AIIMS public relations officer, refuting media reports that the deaths of children were due to the treatment under trials, said all the studies had undergone scientific scrutiny and had all the required regulatory and ethical approvals.
''Reports in some print and electronic media based on an RTI enquiry have erroneously created an impression that 49 babies died due to the treatments being investigated in clinical trials at AIIMS. Insinuations have been made that AIIMS used new drugs that had earlier been used in children, that these studies were conducted exclusively in India, and selectively on children from poor illiterate families.
However, none of these trials were done exclusively on Indian children. Also, medicines for treatment of high BP, namely, valsartan and olmesartan, have been marketed in India for over three years. These drugs have relatively much less side effects than other drugs for blood pressure. Further, this group of medicines has been safely and effectively used in children with high blood pressure worldwide,''the statement by AIIMS said.
Terming as ''absolutely inorrect'' the conclusions drawn by some sections of the media that the pharmaceutical funded trials were responsible for the deaths, AIIMS said,''only six of the 42 trials done were funded by pharmaceutical industry and involved about five per cent of the enrolled children.
The mandatory permissions of the Drugs Controller General (India) were duly obtained for all these studies. It is important to note that there were no deaths in these studies.'' Stating that ''there was no question of targeting any socio economic group selectively'', AIIMS said,''in none of the studies conducted by the department of pediatrics, socio economic status was a criterion for inclusion or exclusion. The enrolled children represented the prevailing mix of patients treated at the institute.'' UNI AR SB HS1707