Jacqueline Sherris

Introduction of Human Papillomavirus Vaccines into Developing Countries -International Strategies for Funding and Procurement

This paper explores different international vaccine financing and procurement strategies used by the Pan American Health Organization, United Nations Childrens Fund, the Global Alliance for Vaccines and Immunization, the Gulf Cooperation Model, and the Advanced Market Commitments. The aim is to identify lessons learned to help ensure equitable distribution of life-saving vaccines for cervical cancer prevention, with particular emphasis on sustainability. A critical first step in the cascade of activities necessary for Human papillomavirus (HPV) vaccine introduction should be the creation of an informed policy decision making process that is grounded in the best available information at a national level. This process will help ensure that decisions are financially sustainable. Any vaccine purchasing mechanisms should address the following essential points: 1) prioritization of cost-saving interventions; 2) flexible participation; 3) sufficient support to confront in-country challenges for managing vaccine procurement mechanisms; 4) a definite time-line for country ownership of vaccine purchases; 5) accuracy of vaccine demand forecasting; 6) maintenance of vaccine supply chains; and 7) well-functioning surveillance and regulatory bodies. In mapping the way forward, using the lessons learned and maintaining flexibility of financing and procurement mechanisms remain critical issues.

Cervical cancer: evolving prevention strategies for developing countries.

Abstract Although highly preventable, cervical cancer is a leading cause ofillness and death from cancer among women in many regions, 80 per cent of deaths occur in women in developing countries. Scarce resources, limited infrastructure and competing health priorities have prevented most developing country health systems from implementing successful cervical cancer prevention and control programmes. Existing resources have typicallybeen allocated to high-cost treatment for late-stage disease, which rarely saves womens lives. Alternate approaches, including visual inspection techniques for screening and treatment on an outpatientbasis by health workers, may help to make prevention programmes more viable where resources are limited. Public health approaches for preventing cervical cancer are essential to reducing mortality.

ALLIANCE FOR CERVICAL CANCER PREVENTION: SETTING THE RECORD STRAIGHT

The recently published article by Suba et al.1 advocates for expanded access to Papanicolaou testing worldwide and for analysis of obstacles to effective screening programs. We are pleased to see discussion of this important topic in the Journal. Suba et al. criticized the work of the Alliance for Cervical Cancer Prevention (ACCP), an alliance of 5 organizations with a goal of reducing cervical cancer deaths among the world’s poorest women. The article repeats previous criticisms the authors have made,2 including about the safety of visual screening approaches, the ethics of several ACCP studies, the assertion that ACCP leaders are “loath to recommend”1(p50) cytology, and the theoretical underpinnings of ACCP cost analyses. We strongly disagree with the authors’ comments about our work and have responded in detail to these criticisms previously. We refer Journal readers to our most recent response to Suba et al.3 and to the voluminous evidence describing our work, a small portion of which is cited here.4–10 The comprehensive work of the ACCP can be reviewed online (http://www.alliance-cxca.org); we invite readers to visit the site and make their own determinations regarding ACCP’s ethical, clinical, scientific, and public health value. Another recurring criticism that Suba et al. make about ACCP’s work is that it is influenced by private-sector interests. We would like to take this opportunity to set the record straight. The ACCP has never received funding from any commercial entity. An erroneous statement about an ACCP link with Digene Corporation in a 2004 editorial has been corrected.11 Suba et al. may be misinterpreting PATH’s separate START project (http://www.path.org/projects/start_project.php), which is working to develop simple, rapid, and affordable biochemical screening tests (including a simpler human papilloma-virus test) in partnership with 2 private-sector companies. The START project is funded by the Bill & Melinda Gates Foundation and the National Institutes of Health; PATH receives no funding from commercial partners for START work. It is regrettable that Suba et al. discourage new approaches to cervical cancer prevention, often with arguments based on uninformed or inaccurate information. We believe that there are multiple strategies to prevent cervical cancer, including well-run cytology-based programs, human papilloma-virus DNA testing–based programs, “screen-and-treat” programs, and human papilloma-virus vaccine introduction. Women in developing countries clearly will benefit from the new policies, programs, and pilot efforts related to these approaches.

Reply to: Austin et al. CytoJournal 2009;6:12 (Unfounded claims mar scientific critique)

To the Editor, Austin and Zhao[1] raise accusations of anticytology bias and conflict of interest in the cervical cancer screening study published by Sankaranarayanan et al.,[2] which was very surprising as these were a repetition of the same previously published (and refuted) charges. The authors note that “questions have been raised” about the Alliance for Cervical Cancer Prevention (ACCP; see www.alliance-cxca.org) and its objectivity with regard to human papillomavirus (HPV) tests. They fail to acknowledge that all these questions have been repeatedly raised by the same person (lead author on all three references cited) and that they have also been answered in a peer-reviewed journal.[3] They also fail to acknowledge that the ACCP, for the past 8 years and in 20 countries, has assessed a variety of approaches to cervical cancer screening, including cytology.[4] Contrary to what is implied by Austin and Zhao, the ACCP—and, in particular, its coordinating organization, PATH—has not received any funding from the HPV test manufacturer for this or any other ACCP study. PATH has, in fact, been working with the manufacturer to develop a lower cost and simpler alternative to their current HPV test that would be more suitable for developing-country use. Unless the authors are charging that the supposed conflict of interest led to a flawed study design (in which case they should point out the flaw) or to deliberate data manipulation (a serious charge of scientific misconduct for which they must provide solid evidence), the claims simply cloud the scientific debate with unfounded accusations and do a disservice to readers. We, as members of the ACCP, are committed to making screening and treatment technologies available that are feasible and effective in low-resource settings. If our pragmatic and evidence-based approach means that we are “enamored of the promise of science,” we have no difficulty with that charge. ACCP, without industry funding, continues to undertake a coordinated research agenda to assess cervical cancer screening and treatment approaches suited to low-resource settings, to improve service delivery systems, to ensure that community perspectives and needs are considered in programs, and to heighten awareness of cervical cancer prevention. We will continue to evaluate new data as it becomes available, but we will not sit by and watch women die needlessly when we can get started now with the tools we already have at hand and for which solid data exist—including visual inspection and, when less-expensive tests become available, HPV testing.