A parliamentary standing committee on health has found in its report, with regard to the Alleged Irregularities in the Conduct of Studies Using Human Papilloma Virus (HPV) Vaccine, that the US based non profit agency PATH violated all laws and regulations laid down for the clinical trials while conducting HPV vaccines trials in Andhra Pradesh and Gujarat.
The report validates the critique by various organizations working on this issue, including AIDWA, SAMA, Jan Swasthya Abhiyaan, etc, who had protested against the unethical nature of the HPV trials carried out by PATH in Andhra Pradesh
(AP), and Gujarat, and demanded a proper enquiry, and action against those responsible for it.
The Standing Committee took up the report on the complaint of the former MP, Brinda Karat, who was a member of the Committee, and on whose detailed report to the Committee, the investigation was conducted. All the points raised in the complaint have been proven right.
The HPV vaccination programme was launched with young tribal girls in certain districts of AP and Gujarat, with the approval of the respective state governments, and the Indian Council of Medical research (ICMR) as a demonstration project from July 2009.
“Though the vaccination’s efficacy in preventing cervical cancer amongst pre puberty girls, as claimed by its producers Merck, Sharpe and Dohme, was unproven, the drug Gardasil had been allowed to be administered in backward districts of our country under the aegis of PATH, which is one of the world’s largest health care NGOs,” AIDWA said in a statement.
In Khammam district of AP alone, 14,000 girls were identified - a large percentage of them from poor, tribal families- for vaccination with three doses of Gardasil, in the three zones selected in the district were Thirumalayapalem (urban), Kothagudem (rural) and Bhadrachalam (tribal). There was virtually no dissemination of information before the actual vaccination about the nature of the drug or its side effects.
The Andhra state unit of AIDWA brought the issue to the attention of the authorities, after the death of two young tribal girls – (Sode Sayamma and Kudumula Saritha) were registered as suicides due to intake of poison when in fact these deaths were related to the administration of the HPV vaccine.
Four tribal girls lost their lives as a result of the side effects linked to the drug. Many more girls suffered from severe headache, stomach ache, vomiting, etc.
“The current report has rightly concluded that by conducting clinical trials on the pretext of observation/demonstration project, PATH has violated all laws and regulations laid down for clinical trials by the Government of India. It is shocking that no action has been taken yet against those responsible,” added AIDWA.
The report holds the Government accountable for the gross irregularities in the HPV trial, and has been held to task for the grave weaknesses in the monitoring of cases. The report has indicted the ICMR representative who, “instead of ensuring highest levels of ethical standards in research studies, apparently acted at the behest of PATH in promoting the interests of the manufacturers of the HPV vaccine.”
It has recommended that the Government should take action against PATH for its violation, and has suggested that the “National Human Rights Commission (NHRC) and National Commission for Protection of Children Rights (NCPCR) may take up this matter further from the point of view of violation of human rights and child abuse”.
Moreover, the report has recommended that the ministry of health and family welfare (MoHFW) should report to the WHO and UNICEF about the unethical practices adopted by PATH, so as to ensure appropriate remedial action at the international level. These are significant recommendations, and need to be taken up seriously.
AIDWA has demanded that the 72nd Parliamentary Standing Committee's report be acted upon immediately. Those responsible for the violations should be penalized. All the victims must receive the compensation they are entitled to, and rehabilitation must be assured for them and the families of the girls who died. The regulatory procedures should be stringently applied, and not be tweaked for the benefit of multinational concerns.
AIDWA said that unless proved totally safe, and cost effective, no such drugs should be administered through the public health system. The haste with which permission was given to private agencies for marketing of the HPV drugs in India, in violation of rules, remains an important issue to be addressed.
AIDWA urged the Government to ensure that the recommendations made by the Standing Committee Report are implemented effectively, without delay or procrastin.