The once hotly tipped Indian clinical trial sector has slowed in recent years as criticisms of overseas organizations have intensified and factions have fought over how best to regulate studies. Nonprofit PATH is the latest to come under attack.
PATH made headlines in India this week after a parliamentary committee accused it of subterfuge. The accusation relates to a human papillomavirus (HPV) vaccine project that gave GlaxoSmithKline's ($GSK) Cervarix and Merck's ($MRK) Gardasil to girls in two Indian states. PATH described the work as a "demonstration project" designed to help understand how best to roll out Cervarix and Gardasil in the developing world. The committee rejected this description. In a report it called the project a clinical trial that Indian authorities failed to properly monitor.
Work on the project stopped in 2010 amid concerns about ethical irregularities. After investigating the allegations, the parliamentary committee claims people administering the vaccines failed to get genuine informed consent from the parents or guardians of the girls. PATH maintains that vaccines were given after parents or guardians provided written, informed consent and girls gave verbal assent. Informed consent is one of several topics on which PATH and the committee have differing opinions.
In a statement PATH called the report an "inaccurate characterization" of an important project. "The Indian Council of Medical Research determined the project was a post-licensure observational study and not a clinical trial. The project did not seek to evaluate the efficacy or long-term safety of the vaccines, which had already undergone clinical evaluation in India and had been licensed and approved by the Drugs Controller General of India," PATH wrote.