NHRC issues notice to AIIMS(http://timesofindia.indiatimes.com)

29 Aug 2008 The Times of India NEW DELHI: The National Human Rights Commission (NHRC) has issued a showcause notice to the health ministry and the All India Institute of Medical Sciences (AIIMS) over the deaths of 49 infants during clinical trials, even as the nationally renowned institution defended the experiments.

"This is a show cause notice. We have sought comments from the secretary of the health ministry and the AIIMS director on a complaint filed with the NHRC within four weeks," a commission official said.Rahul Verma of the NGO ‘Uday Foundation' had submitted a petition to the NHRC, alleging violation of right to life under Article 21 of the Constitution.

In a statement, the institute said the drugs used in the tests were safe and the children were not selected from a particular socio-economic group. It added that none of the 49 deaths were due to the treatment modalities under trial. The drugs studied had been found safe in earlier studies, and were not known to have fatal complications. In fact, the deaths were due to high risk and serious disease conditions which the children suffered from.

The statement said: "Only six of the 42 trials done were funded by the pharmaceutical industry and involved about 5% of all enrolled children. All the study protocols were approved by the nationally acclaimed Ethics Committee of AIIMS in which half of the members are from outside, including one eminent jurist. The mandatory permissions of the Drugs Controller General (India) were duly obtained for all these studies. There were no deaths in these six studies."

It added, "In one of the six above mentioned studies, immunogenicity of an indigenously manufactured DTPw-Hib tetravalent vaccine was tested. For the other five studies, AIIMS was one of the many centres in these multi-country, multi-site drug trials which included a significant number of children from US, Europe and Russia and several sites in India. Altogether, only 25 children were enrolled at AIIMS. It is emphasized that none of these trials were done exclusively on Indian children. None of the drugs were tested on healthy children."

The statement then went on to say, "The 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.

This group of medicines has been safely and effectively used with children having high blood pressure worldwide. The 49 deaths reported occurred in children with sepsis, and those with respiratory failure receiving life support. The deaths were due to the natural history of the severe diseases the children suffered from."
Source:- http://timesofindia.indiatimes.com/Delhi/NHRC_issues_notice_to_AIIMS/articleshow/3418981.cms