Statement from PATH: Cervical cancer demonstration project in India

Statement from PATH: Cervical cancer demonstration project in India
30 August 2013
Excerpt
Today, the Indian Parliament’s Standing Committee on Health and Family Welfare released a report critical of a cervical cancer vaccine demonstration project conducted in India from 2009 to 2010 through a collaboration among PATH, the Indian Council of Medical Research (ICMR), and the state governments of Andhra Pradesh and Gujarat.

PATH welcomes public discussion about the role of vaccines in preventing life-threatening diseases such as cervical cancer, and we thank the committee members for their time and effort in reviewing this matter. We support the adoption of reasonable measures to further strengthen and clarify protections for individuals participating in research projects. However, we are troubled by the report’s inaccurate characterization of this important work.

…The demonstration project in India was part of a four-country project to explore suitable vaccine delivery strategies and help provide evidence for national health authorities to make informed decisions about the potential benefits and challenges of introducing vaccines against human papillomavirus (HPV), the primary cause of cervical cancer.

…The ICMR, India’s highest medical research authority, reviewed and approved the protocol for this project, including its design and methodology. At the time of its review, the ICMR 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.

The ICMR’s view was crucial, as it established the approval processes and protocols for the work that followed. PATH designed the project protocols in compliance with the ICMR’s instructions and fully complied with the ICMR’s requirements regarding the necessary approval processes and the requirements of state governments regarding consent processes.

We believe that by following the guidance provided by the ICMR, as well as two state governments and three ethical review committees, we designed a project that met or exceeded the country’s existing regulatory standards for demonstration projects while providing the greatest health benefit to Indian women…

–       Full PATH statement: http://www.path.org/news/press-room/642/
–       Standing Committee Report: [no link provided in PATH statement; no web version apparent after google search]