Controversial HPV vaccination in AP becomes murkier

Seven adolescent girls in the state reportedly died during the trials

Andhra Pradesh government issued an official order asking hostel wardens and principals of schools to sign the consent form on behalf of their parents. In some cases, illiterate parents were asked to give their thumb impression on the consent without any explanation before their girls were administered the vaccine.

Following the widespread criticism, when the Centre began the investigation, ICMR, which approved the trial in 2007, asked the same officer, who was a part of the planning team, to also be a part of investigation giving him access to probe documents, which activists claim, may be used to clean up the tracks.

More than 24,000 adolescent girls were subject to HPV vaccination in one district of Andhra Pradesh and Gujarat each in 2009 as a part of the trial that was meant to find out whether the vaccine can later be introduced in the universal immunisation programme.

Seven girls died during the trials though it is not known whether the deaths are related to the vaccine trial. In a letter to Union Health Minister Ghulam Nabi Azad, CPM leader Brinda Karat  demanded the scrapping of the project and said in future no NGO should be allowed to take up such a project involving a large number of children.

Quoting a report submitted by a high-level committee appointed by the government to look into the vaccine drive, she said the report has brought out “shocking findings” about violations in the project and questioned the lack of ethical standards.

“Strong action is required against the officials at various levels starting with the ICMR. The project itself must be scrapped and in future no NGO should be allowed to take up such a project involving a large number of children,” the CPM’s Politburo member said in the letter.

“There has been a serious dereliction of duty by many of the institutions involved. In particular the role of the ICMR has been extremely questionable,” she said. An investigation panel set up by the Centre picked up many holes in the entire trial but stopped short of fixing the responsibility on any specific individual.

A team of three Delhi-based senior doctors who assisted the investigation panel found almost everything was wrong in the HPV vaccine trial, the most prominent one being “questionable lack of ethical standards.”

The most glaring example was related to consent form. In any drug trial involving the minors, informed consent of their parents is absolutely must before the inoculation. However, Andhra Pradesh government brought out an official order (dated June 2, 2009) asking the deputy medical and health officer in Bhadrachalam block to issue orders to all the hostel wardens and Ashram schools to sign the consent forms on behalf of the parents. In case of 2,763 girls, consent documents were signed en bloc by teachers, hostel wardens and head masters. This is illegal. In another 1948 cases, illiterate parents were asked to put thumb impressions on documents, which they could not understand.

There are 69 consent forms without the witness signature and there are four cases where the names of parents or guardians given in the consent form do not match with the signature.“All consent forms have been very carelessly filled and are incomplete and probably inaccurate,” said Rani Kumar, dean of All India Institute of Medical Sciences here who was one of the three doctors who assisted the probe panel.