Act of wilful negligence

The issue of HPV trials on children in Andhra Pradesh (Khammam district) and Gujarat (Vadodara district) since April 2010, resulting in the death of seven children exposed the failures, irregularities and corruption in our regulatory system of both Centre and States.

The 72nd PSC report states that an American agency viz. Programme for Appropriate Technology in Health (PATH), funded by Bill and Melinda Gates Foundation, violated laws and regulations by carrying out clinical trials on the pretext of observation/demonstration project.

Experts appeared before the Committee pointed out defects in reporting and dealing with serious adverse events, lack of preparedness if risk occurred. The side effects mentioned by the manufacturers themselves were revised several times and now include serious health issues. Since there were contraindications to the use of the vaccines, the reasons for not ascertaining contra-indications before the girls were vaccinated is clearly an act of wilful negligence.

A number of discrepancies and gaps in the investigations of the deaths have also been pointed out. There was no diary card based reporting of adverse events for recording minor or major adverse events in the study protocol in such a large study. This resulted in gross under reporting of the adverse events.

Second expert, while analysing deaths and Adverse Events Following Immunizations (AEFI), has observed, after reviewing all seven deaths (five deaths from AP in the Gardasil group and two deaths in Gujarat from Cervarix group), that there was no common pattern to the deaths that would suggest that these were caused by the vaccine.

However, the reporting system as per Government of India surveillance of vaccine preventable disease guidelines notification was not done within time limits in two cases in AP and both the cases in Gujarat. There was no uniformity in the reporting system of AEFI in both the States. The primary end point of the study was to find out the number of girls having serious and non-serious adverse events following vaccination through routine UIP system. He has opined that in this regard, first of all, routine system of reporting should have been verified in both States.

Third expert has stated that the reporting of non-serious adverse effects (AE)s was grossly under reported and hence the accuracy of Serious Adverse Events (SAE) is doubtful as well. It has been observed that delay in reporting and investigations of deaths could have been due to sole dependence on routine UIP protocol. It was a significant lapse in the protocol and execution of the study.

While reporting on safety aspects in the study, it has been pointed out that there was absence of preparedness to handle (SAE) like anaphylaxis, cardiac arrest, seizures, etc., occurring at the sites of vaccine administration. Though such serious adverse events might be rare but it was advisable to be well-prepared for such an eventuality through adequate training of health workers.

Assessment of the immune status of the participants by the ANM, ASHA or the health workers was virtually non-existent. These issues needed to be addressed as prescribing information of the HPV vaccines specifically contra-indicates administration in immune-compromised subjects (such as HIV/AIDS etc.) The methodology and implementation of the study at both the places was full of flaws.

PSC advised utmost caution since the population under study was vulnerable, in the implementation of the study. It suggested an independent monitoring mechanism in such a study involving human participants so that the accurate recording of AEs and SAEs could be made.

The findings of the experts clearly indicate that the safety and rights of the children in this vaccination project were highly compromised and violated. PSC was also concerned over the fact that there was no insurance cover for the children.

The Committee strongly recommends that while allowing any such trial in future, all the lapses pointed out by the experts should be addressed effectively. ICMR and DCGI should ensure strict adherence to the guidelines, methodology and monitoring.

The Ethics Committees existed only as a formality and they did not play the role they were designated for. This is a clear dereliction of duty on the part of the Ethics Committees. There should be a mechanism in place to take appropriate action against such dereliction of duty on the part of the Ethics Committees. The Committee wanted specific guidelines for the Ethics Committee, which has to follow strictly, and its functioning needs to be regulated.
The Brajesh Pathak Committee in 72nd report recommended that such practices of diverting public funds for advancing interests of a private agency should never be allowed in future, and strongly recommended strict action against those officials for such lapses.

Considering the above lapses and irregularities committed by PATH during the course of conducting the trials on hapless tribal children in Andhra Pradesh and Gujarat, the Committee is convinced that the authorities concerned did not exercise due diligence in scrutinizing the publicity material of PATH. The Committee recommended Ministry to investigate into acts of omissions and commissions and take necessary action against responsible for breaches.

The Inquiry Committee pointed out: (i) Irregularities in obtaining consent forms and actual implementation of the consent process; (ii) Lack of monitoring and preparedness to deal with serious adverse events; (iii) Inclusion o f vulnerable and tribal population groups; (iv) Blurring of distinction between U n i v e r s a l Immunization Programme and PATH study; (v) Absence of insurance coverage for the study participants; and (vi) Inclusion of the statement in the consent form that "you will not be charged for your daughter to receive the vaccine" that could be construed as covert inducement. The PSC asked whether any action was taken and compensation was given to family of children for suppression of material information before administering vaccines.