Flouting Ethics, A PATH of Violations. 7 Dead in India Vaccine Trials
Christof Lehmann (nsnbc) , – Flouting Ethics and a PATH of Violations were words used after a parliamentary panel in India looked into the conduct of clinical trials for HPV (cervical cancer) vaccines in Andhra Pradesh and Gurajat three years ago.
Seven tribal girls died as a consequence of the trials, which according to the parliamentary panel have “violated all laws and regulations”.
PATH, involved in promoting the vaccine, is sponsored by the Bill and Melinda Gates Foundation, which also is implicated into the Polio vaccine related paralysis death of 47.500 Indian children.
In its 72nd report, tabled in the Lok Sabha on Friday, 30 August, the parliamentary panel has stated, that the trials have violated all laws and regulations which the government has laid down for clinical trials. The trials have been conducted by the US – based Program for Appropriate Technology in Health (PATH), under the pretext of an observation – demonstration project. PATH is receiving funding from the Bill and Melinda Gates Foundation, which has also been implicated in another, vaccine-related scandal in India, with the Polio vaccine being the most likely cause of the paralysis death of 47.500 children in India.
The parliamentary panel has sought action against “the wrong doers” and stresses, that the government ought to be more vigilant and tighten regulatory measures and instruments further. The parliamentary panel questions the role of the ICMR in the 2010 episode and accuses PATH of exployting, with impunity the loopholes in the system during the trial of Human Papillomavirus (HPV) vaccines. The panel also questioned the role of the Indian Council of Medical Research and the Drug Controller General in the episode.
The trials were conducted on tribal school girls in the Khamman district in Andhra Pradesh and Vadodara in Gujarat, and were only brought to an end after the scandal received the media´s attention, following the tragic death of seven of the schoolgirls.
In the panel´s report, titled “Alleged Irregularities in the Conduct of Studies using HPV vaccines by PATH in India”, the panel criticized the ICMR apparently to act at the behest of PATH in promoting the interests of the vaccine manufacturers.
The panel also stressed the role of the DCGI in the matter, saying that approvals of clinical trials, marketing approval and import licensing by the DCGI “appear to be irregular and that this entire matter also should be inquired into”.
The panel criticized the Department of Health Research /ICMR for having failed completely to perform their mandated role and responsibilities, describing them as over-enthusiastic and as acting as a willing facilitator of the machinations of PATH by transgressing into the domain of other agencies. The panel stressed, that this conduct deserves the strongest condemnation, saying:
“The committee failed to understand why the ICMR took so much interest and initiative in this project when the safety, efficacy and introduction of vaccines in India are handled by the National Technical Advisory Group on Immunization”.
The panel asked, how the ICMR could commit itself to supporting the use of the HPV vaccine in an MoU, signed in 2007, even before it was even approved for use in the country, which actually happened in 2008 ? Moreover, the panel asked, how the ICMR could explain its decision to commit itself to promoting the drug for inclusion in the Universal Immunization program, before even any independent study on its utility and rationale for inclusion in the program had been undertaken, saying that:
“The entire matter is very intriguing and fishy”.
The panel stressed, that gross violations of ethics have been committed during the trials, pointing out gross irregularities with regards to informed consent. In Andhra Pradesh, so the panel, out of 9.543 consent forms, 1.948 had thumb impressions, while hostels wardens signed 2.763 others. In Gurajat, out of 6.217, 3.944 had thumb impressions. The panel stressed, that the data revealed, that a very large number of the parents or guardians were illiterate and could not even write in their own, local language, Telugu or Gujarati. In its report, the panel stated:
“It was shocking to find from one of the reports that out of 100 consent forms for Andhra Pradesh, project signatures of witnesses were missing in 69 forms. In many forms there were no dates. One particular person had signed seven forms. In fact, the legality of the State government directing headmasters of all private/government/ashram/schools to sign the consent forms on behalf of parents/guardians was highly questionable. The absence of photographs of parents/guardians/wardens on consent forms and of signatures of investigators, the fact that the signatures of parents/guardians did not match with their names; and the date of vaccination being much earlier than the date of signature of parents/guardian in the consent forms spoke of grave irregularities”.
The committee stressed, that PATH should be held accountable and that the government should take appropriate steps, including legal action against PATH, for its breaches of the laws of the land and for possible violations of the laws of its country of origin. The panel emphasized, that the conduct of PATH in this case is a clear-cut violation of human rights and a case of child abuse.
The panel recommended, that the National Human Rights Commission and the National Commission for the Protection of Children Rights should take up this matter, and that the National Commission for Women should also take suo motu cognisance of this case as all of the trial subjects were female. The panel also encouraged the government to report PATH´s violations to the World Health Organization and the United Nations Children´s Fund.