Indian Institute Defends Conduct of Clinical Trials

Amid calls for an investigation, the All India Institute of Medical Sciences (AIIMS) denies that the deaths of 49 infants were caused by investigational drugs, saying the children already were seriously ill.

Daiichi Sankyo and Novartis, which sponsored two of the studies, say none of their participants died. The deaths occurred in studies conducted by the institute’s Department of Pediatrics beginning in 2006, which enrolled a total of 4,142 subjects — 2,728 of whom were younger than 1 year old, the institute says.

All the deaths “were due to the natural history of the severe disease that the children already suffered,” AIIMS says.

The Uday Foundation for Congenital Defects and Rare Blood Groups, an Indian nongovernmental organization, says in a letter to the country’s National Human Rights Commission that it had filed a right-to-information request with AIIMS, which has not said how many died in the treatment arms and how many died in the control arms of the studies. The foundation is calling for an investigation of the deaths as a serious human rights violation.

AIIMS says that “only six of the 42 trials done were funded by pharmaceutical industry and involved about 5 percent 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.”

Two of the industry-sponsored trials were for Daiichi Sankyo’s Benicar (olmesartan medoxomil) and Novartis’ Diovan (valsartan), both hypertension drugs. The Uday Foundation says neither drug had been tried on pediatric patients before the AIIMS studies.

“We have received no reports of any serious adverse events for any of our studies for valsartan,” Novartis spokesman Eric Althoff said. He said AIIMS serves as a contract research organization for the study, which is an ongoing Phase IV postmarketing trial.