Question of Ethics

By T.K. Rajalakshmi

The effectiveness of the HPV vaccine in preventing cervical cancer was tested without proper consent from vulnerable subjects.

EARLY last year, an ambitious, population-based, post-licensure study of the effectiveness of the human papillomavirus (HPV) vaccine to prevent cervical cancer conducted in selected districts of Andhra Pradesh and Gujarat by PATH, an international non-governmental organisation, ran aground following the death of seven girls. The conduct of the study has now come in for much criticism from a government inquiry committee constituted to look into it. It has drawn flak mostly for deficiencies in obtaining consent in the case of vulnerable groups. The report is not yet in the public domain.

India is said to have one-fourth of the world’s cervical cancer patients, and PATH initiated a five-year project to advance the prevention of the disease. The three-phase study was done in collaboration with the Indian Council of Medical Research (ICMR) to generate “evidence that would enable policymakers to decide on possible public sector introduction of the HPV vaccine”. The Rs.250-million project, titled “HPV Vaccine: Evidence for Impact”, was funded by the Bill and Melinda Gates Foundation. The vaccine for the project came as donations from GlaxoSmithKline and Merck Sharp & Dohme. The project had all the approvals from the designated agencies.

The objectives of the study were threefold: to demonstrate suitable HPV vaccine delivery strategy for 10- to 14-year-old adolescent girls; to raise community awareness of HPV, cancer of the cervix and its prevention; and to gain experience in HPV vaccination and to build the evidence base of vaccine delivery strategies for the future introduction of HPV vaccine in the universal immunisation programme. The target group of the demonstration project was 16,000 girls in three blocks each in Khammam district in Andhra Pradesh and Vadodara district in Gujarat.

The project was carried out in a public-private partnership (PPP) model with the approval of the two State governments, with the ICMR involved in it from the beginning as an adviser and facilitator. The vaccination started in Khammam in July 2009 and in Vadodara the following month. As many as 14,091 girls in Khammam were given the first dose of the vaccine, 13,930 the second dose and 13,791 a third dose. The corresponding numbers in Vadodara were 10,686, 10,259 and 9,637.

The project attracted wide attention in the media following the death of seven girls (five in Andhra Pradesh and two in Gujarat), and the Central government decided to suspend the study. On April 15, 2010, a four-member (later reduced to three) committee was constituted to look into the alleged “irregularities in the conduct of studies using HPV vaccine by PATH in India”. The committee comprised Professor S.P. Agarwal, former Director-General, Health Services, Ministry of Health and Family Welfare and current Secretary-General of the Indian Red Cross Society; Dr Suneeta Mittal, professor and head of the Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences (AIIMS); and S.S. Agarwal, former Director, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow. The committee was further assisted by three experts. Early this year, the findings of the interim report of the committee were selectively leaked to the media. The final report, which was out in February, is yet to be placed in the public domain. It is interesting to note that though the inquiry committee did not find any link between the deaths and vaccination, it found lapses as far as protocols of clinical trials and ethical issues of consent, particularly in the case of vulnerable groups, were concerned.

The committee has come out with many damaging conclusions, which throw light on the manner in which health care and the financing of projects under PPP arrangements are managed in the country.

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