Statement from PATH: cervical cancer demonstration project in India

September 3, 2013 by PATH

Amy MacIver, 206.302.4522,

Updated September 3, 2013.

As media coverage and discussions unfold regarding the recently released report from the Indian Parliament's Standing Committee on Health and Family Welfare, PATH reaffirms its position on the report. While PATH welcomes the transparency and discussion of our work, we strongly disagree with the findings, conclusions, and tone of the released report and its disregard of the evidence and facts.

In particular, the report ignores the now voluminous evidence on the safety (225 KB PDF) and efficacy (176 KB PDF) of HPV vaccines and falsely suggests that deaths may be causally linked to the vaccines. This is not only inaccurate, but may have tragic consequences for delivering these and other lifesaving vaccines to those who need them most.

As with all public health projects that work to save lives through immunizations, the vaccines must be procured from a manufacturer. The vaccines used in this study were donated by the respective manufacturers, Merck & Co. Inc. (Merck) and GlaxoSmithKline (GSK). No pharmaceutical company was involved in the design, implementation, or evaluation of the project, nor did they fund any part of this work. PATH is a not-for-profit organization that has no financial stake in the vaccine and received no funding from the manufacturers for this work.  The study was fully funded by the Bill & Melinda Gates Foundation.

PATH works with hundreds of diverse partners, mobilizing the expertise and resources of in-country and public, private, and nonprofit entities. Any suggestion that inappropriate collusion existed in this project is baseless, wholly inaccurate, and defies the very spirit of our cross-sector partnerships, which are essential in India and around the world.

PATH has been a leader for the past 20 years in the effort to reduce the toll of cervical cancer, through screening and more recently through HPV vaccines. As India bears one-quarter of the world's burden of cervical cancer, which kills an estimated 72,825 Indian women annually, we believe that poor and low-income girls in India should not be denied the right or access to this proven, lifesaving, and safe vaccine that wealthy and middle-class girls in India and around the world have access to through the private market and other public immunization programs. We are committed to our institutional legacy of ethical, evidence-based work on transformative innovations that save lives.

Posted August 30, 2013.

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.

PATH, an international nonprofit organization, is committed to meeting the highest scientific, ethical, and legal standards in our work and to contributing our experience and expertise to address the burden of cervical cancer through transformative innovations such as vaccines. 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.       

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.

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.

It is important to note that the safety of HPV vaccines had already been scientifically established through clinical trials in India and other countries before any use of the vaccines in this demonstration project. Scientific evidence continues to show that the vaccines have excellent safety profiles, with more than 100 million vaccine doses delivered and not a single death causally associated with the vaccine anywhere in the world.

HPV vaccines are currently licensed and available in India and more than 120 other countries. At least 40 countries include them in their national immunization programs. The HPV vaccines used in the project had been licensed and approved by the Drugs Controller General of India before any vaccines were administered, and HPV vaccination had been recommended by the Federation of Obstetric and Gynaecological Societies of India, the World Health Organization, and the US Centers for Disease Control and Prevention, among others. HPV vaccines remain available in India today from private medical providers serving primarily wealthy families but not from the Indian public health system.

An essential goal of the project was to understand the challenges of equitable introduction of HPV vaccines in routine public-sector immunization services. In support of that goal, state authorities and PATH worked together to ensure an economically diverse group of project participants, including urban, rural, and tribal populations. Specific districts and blocks within those districts were selected in consultation with state officials, the ICMR, and state-level project advisory groups to ensure that project participants were representative of all segments of society. HPV vaccines were then made available to 10- to 14-year-old girls in the project sites, regardless of their social, economic, ethnic, or religious status, if their parents or guardians provided written, informed consent and if the girls provided verbal assent.

India bears a disproportionate share of the burden of cervical cancer deaths, and girls in low-income areas are least likely to have access to the vaccines that could save their lives. It is both scientifically sound and morally imperative to include underserved populations in our work to improve health in India and around the globe. For adult women, who would not benefit from the vaccine, PATH also worked to strengthen screening programs in the project areas.

The demonstration 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.

PATH's mission is to improve the health of people around the world by advancing technologies, strengthening systems, and encouraging healthy behaviors. We believe that no woman should die from cervical cancer because of where she lives or her economic circumstances. A comprehensive cervical cancer prevention strategy that includes vaccination and screening has the potential to save millions of lives over the next decades. PATH is committed to collaborating with our partners, in India and around the world, to help ensure that every girl has access to HPV vaccination and every woman has a chance to be screened for cervical cancer at least once in her adult life.