Saheli finds Enquiry of PATH project on HPV vaccines still shielding the guilty
Our worst fears about unethical conduct of bio-medical research have been confirmed by the interim report of the enquiry panel set up by the Ministry of Health and Family Welfare to enquire into violations in PATH-ICMR project though on each count the enquiry has fallen short of full investigation and on fixing responsibilities.
It has drawn attention to the fact that in getting vaccines free of cost from the two companies does raise concerns about undeclared conflict of interest since the results of the study may be used to influence the decision by the government. But it has failed to note that PATH itself was funded for this exercise by Bill and Melinda Gates Foundation which had a substantial share in Merck at the time the formative research by PATH was conducted and its findings used to carry out the project under question.
The report has warned that vaccination should be viewed as a supplement to cervical cancer screening and not to replace such a programme. We have constantly drawn attention to the fact that in the entire district of Khammam where the said project is going on there are no screening facilities. The enquiry panel has not commented on this single minded pursuit of vaccines.
The enquiry panel has questioned the AP government for authorizing school authorities to sign consent on behalf of minor girls and said that everyone should desist from research on tribal population, except where it benefited them. We welcome this recommendation and hope it is taken seriously. However we wish to reiterate that the panel has not commented on the misinformation contained in the proect literature which mentioned none of the systemic side effects of the vaccines but only talked of minor irritations at the injection site. It has also failed to highlight that there are certain claims made such as no adverse effect on fertility which are as yet unsubstantiated. It has failed to link the unfounded claims to the formative research done by PATH where the villagers had raised concerns about these safety and future fertility very specifically.
The enquiry panel has accepted that the distinction between the regular immunization programme and research was blurred. When we look at findings of PATH formative research we find that this blurring was intentional as the villagers found the regular immunization by the government by and large acceptable and had stated that if the government endorsed the vaccine they would be willing to go ahead with it.
The panel has not commented on the failure of the project to administer three doses systematically. On the basis of information received by us from government records through RTIs filed by us it is amply clear that there have been gross violations in this regard at least in Gujarat where many girls received only two doses as against three and some received only one dose as no repeat visits were made.