Volume 474 Number 7352 pp419-536 23 June 2011
Vaccine trial’s ethics criticized
Collapsed trial fuels unfounded vaccine fears.
A clinical trial that came under fire in India threatens to have a dual legacy: inflaming unfounded fears about a lifesaving vaccine and raising new questions about the management of medical research in the country. After four teenage girls taking part in a test of human papillomavirus (HPV) vaccines died last year, the Indian government faced accusations that its citizens were being used as guinea pigs to test dangerous vaccines. A scientific investigation has exonerated the vaccines but uncovered a more familiar problem in India: ethical irregularities.
The study, funded by the Bill & Melinda Gates Foundation and run by the international health charity PATH and the Indian Council of Medical Research (ICMR), vaccinated more than 23,000 girls aged 10–14 against HPV, which can cause cervical cancer. The vaccines — Merck’s Gardasil and GlaxoSmithKline’s Cervarix — are already in widespread use in the developed world, and the study was designed to assess the feasibility of launching an HPV-immunization programme in the Indian health system. The researchers hoped to gauge public acceptance of the vaccines and assess the costs of administering it in different parts of the country.
A committee of three scientists from the All India Institute of Medical Sciences (AIIMS) in New Delhi, commissioned by the government to look into the trial, confirmed that the deaths were not linked to the vaccines — two of the girls died of poisoning, one of drowning and the fourth of a fever. But its report, leaked to India’s media last month, said that the study involved several serious ethical violations. According to media reports, participants were recruited from vulnerable tribal populations, consent was improperly obtained — headmasters of the girls’ schools signed the forms — and adverse events were poorly recorded…