The project’s aim was, in PATH’s own words, “to generate and disseminate evidence for informed public sector introduction of HPV vaccines”.
It was conducted in four countries: India, Uganda, Peru and Vietnam.
Another Gates-funded organization, Gavi, had originally been considered to run the project, but responsibility was ultimately delegated to PATH. The project was directly funded by BMGF.
Significantly, each of the countries selected for the project had a different ethnic population and each had a state-funded national immunisation program.
The use of different ethnic groups in the trial allowed for comparison of the effects of the vaccine across diverse population groups (ethnicity being a factor in the safety and efficacy of certain drugs).
It’s worth noting here the relationship between BMGF and one of the companies whose drugs were being tested. In 2002, BMGF had, controversially, bought $205m worth of stocks in the pharmaceutical sector, a purchase which included shares in Merck & Co. The move had raised eyebrows because of the obvious conflict of interest between the foundation’s role as a medical charity and its role as an owner of businesses in the same sector.
The Wall Street Journal reported, in August 2009, that the foundation had sold its shares in Merck between 31st March and 30th June of that year, which would have been around the same time that the field trials of the HPV vaccine were starting in India.
So for the entirety of this project (which was already in operation by October 2006), right up to its final field trials, BMGF had a dual role: as both a charity with a responsibility for care, and as a business owner with a responsibility for profit.
In March 2010, members of Sama visited Khammam to find out more about the emerging stories. They were told that up to 120 girls had experienced adverse reactions, including epileptic seizures, severe stomach ache, headaches and mood swings. The Sama representatives remained in Khammam to investigate the situation further.
The involvement of Sama finally brought the matter to the attention of the Indian media and, amid a barrage of negative publicity, the Indian Council of Medical Research (IMCR) suspended the PATH project. At this point the Indian Parliament’s Standing Committee on Health began an investigation into the affair.