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.

 The enquiry panel has agreed that bio-medical guidelines have been violated and adverse events have not been monitored and investigated. This is a major problem because as per the package inserts of Gardasil and Cervarix almost all systems of the body – immune system, musculoskeletal system, blood, and nervous system can be affected by the vaccines. If these are not even recorded on what basis has the claim been made that deficiencies are minor in nature?

 Again death has been mentioned in the US package insert but conveniently removed from the Indian one without carrying out the necessary trials which would have laid the ground for changing the package insert. Yet the enquiry committee has not linked the seven deaths to the array of side effects but has merely drawn a conclusion that the deaths are “most probably unrelated to it, as there is no characteristic and uniform pattern of illness preceding the deaths, or temporal/spatial clustering going by the FIR”. We would like to which FIRs  have been used if the adverse event reporting itself was deficient.

 We had raised the question of ethics of bio-medical research which had been violated by the said project. In fact, the Andhra Pradesh Government had stated before the National Commission for Protection of Child Rights that the question of welfare of the research subjects was “irrelevant” as the vaccines had already been approved by the Drugs Controller General of India and endorsed by various professional bodies.

 Where we disagree totally with the enquiry panel is that it has maintained that the deficiencies are minor in nature. How can violation of rights of 24000 girls be a minor matter? How can printed misinformation overstating benefits and hiding known problems of the vaccines be a minor offence? How can death and debility arising from bio-medical research not even be monitored, treated and compensated? How can these be ignored in the context of  licences which have been granted without phase II and Phase III trials considered necessary by ICMR itself?

 We do not understand what good is going to be achieved from completing the paperwork from this project which has failed to deliver the vaccines, failed to record adverse events and has been conducted in disregard to ethics. No meaningful information or conclusions can be drawn from this exercise.

 The enquiry panel is correct in stating that no one agency could be held entirely accountable for the lapses but the lapses are serious and the case must be put before a competent authority to assess the damage and provide for medical attention and compensation to be recovered from the government, Bill and Melinda Gates Foundation, Merck and GlaxoSmithKline. It is a matter of criminal and financial liability.

 Lastly we welcome the suggestion of the enquiry panel for a review of all pending HPV research projects and demand that this review be held in public domain with full transparency. We demand that the authorities review the licensing of Gardasil and Cervarix which has been done with practically no Indian data and we recommend that in addition to future studies the licence for sale of these vaccines be kept under suspension till adequate data become available after well designed and ethically conducted research among the potential users who can afford the vaccines at the prevailing market price.