The Andhra Pradesh government had issued an order for the smooth implementation of the ‘cancer cervix vaccination programme' in Khammam district. It had ordered all educational institutions to support the efforts of the Health Department in implementing the Human Papilloma Virus (HPV) vaccine programme.
The Deputy District Medical and Health Officer of Bhadrachalam, P. Mohan Rao, had written on June 2, 2009 to the Project Officer of the Integrated Tribal Development Authority (ITDA) instructing him to issue orders to all the “hostel wardens and ashram schools to sign the consent forms on behalf of the adolescent girls to have the vaccine, as contacting parents will be difficult in agency area (Bhadrachalam area).”
“Teachers will help guide in consent process for the day scholars, by inviting the parents to attend the parent teacher meeting if needed. Teachers will support health officials to monitor the vaccination campaign in schools,” he said, further instructing the project officer to issue orders to private school coordinators to support the initiative and participate in the HPV project and provide necessary support to the officials.
As many as 23,000 girls in Andhra Pradesh and Gujarat were vaccinated under the ‘Post-licensure observational study of HPV vaccination Demonstration Project,' carried out by an international non-governmental organisation, PATH, for two American pharmaceutical companies.
However, the Centre suspended the programme following the death of seven girls who had been vaccinated and allegations of violation of ethics in conducting the trial.
‘Casual approach'
Talking to reporters here on Monday, Rajya Sabha member Brinda Karat said the final report of the committee, appointed by the Centre in April last to look into “alleged irregularities in the conduct of studies using Human Papilloma Virus (HPV) vaccine” by PATH in India, had stated that “from the numerical analysis it is obvious that the team involved in conducting the study on HPV has been very casual in its approach and has ignored many ethical issues such as signatures of parents/guardians, witness and there are discrepancies in the date of receiving the vaccine and date of signature.”
A three-member expert committee set up to assist the main committee has, in its report, said that the most significant deficiency in the implementation of the project was obtaining the consent. “The ambivalent sentences in the consent form tantamount to covert inducement and indirect coercion especially in the light of the high cost of the vaccine,” Rani Kumar, Dean of All-India Institute of Medical Sciences, has said in her observation. “This authorisation runs contrary to the basic principles of obtaining consent as students cannot be considered to have full autonomy in front of their teachers.”
“It is extremely alarming that despite clear evidence regarding serious lacunae in such a fundamental aspect of any form of research, no action has been recommended against those involved in the designing and implementation of these projects nor against those ethics committees who approved of such a design,” Ms. Karat said at the press conference which was attended by representatives of Jan Swasthya Abhiya, Sama—Resource Group for Women and Health and Human Rights Law Network among others.
Ms. Karat further pointed out that that one of the roles assigned to the Indian Council of Medical Research (ICMR) in the memorandum of understanding with PATH was to “advise on plans for results dissemination to support decision-making in the use of the HPV vaccine.''
“How could the ICMR have committed itself to support the use of the HPV vaccine in an MoU signed in 2007, even before the vaccine was licensed for sale in India which actually happened in 2008,” she asked.
