PATH rejects standing commitee's report on cervical cancer project

While it acknowledged the role of parliamentary panel on health for initiating public dialogue, PATH has at the same time cautioned against undermining of scientific experiments and data collection as done in case of cervical cancer demonstration project


Politics vs Science: The parliamentary standing commitee's critcal remarks on cancer projects has reviewed debate on the immature political understanding of scienctific methods.

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

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. These projects in India, Peru, Uganda, and Vietnam generated important new evidence on the best ways to introduce HPV vaccines and are informing the work of governments across Africa, Asia, and Latin America to help prevent cervical cancer deaths. The results paved the way for Peru and Uganda to launch national immunization programs against HPV and contributed to the GAVI Alliance's decision to subsidize HPV vaccines for the world's poorest countries.

Responding to the report, PATH issued a statement that welcomeed public discussion about the role of vaccines in preventing life-threatening diseases such as cervical cancer but also rejected the unneccessary crticism of the vaccine project. It mentioned, "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."

Cervical cancer is a preventable disease, yet it kills 275,000 women every year, nearly all of them in low-resource countries. India bears one-quarter of the world's burden of cervical cancer, which kills an estimated 72,825 Indian women annually.

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.

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