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CANADIAN WOMEN'S HEALTH NETWORK: HPV, Vaccines, and Gender: Policy Considerations
Ilena Rosenthal & The Humantics Foundation applaud this fine paper and
are dedicated to spreading this information for anyone considering being or having someone they love vaccinated with Gardasil. http://ilena-rosenthal.blogspot.com http://ilenarose.blogspot.com Health Lover http://www.cwhn.ca/resources/cwhn/hpv-brief.html A summary of this paper is to appear in the 28 August 2007 Canadian Medical Association Journal; a pre-released version can be found online now at: www.cmaj.ca. HPV, Vaccines, and Gender: Policy Considerations (PDF 238k/19p) http://www.cwhn.ca/PDF/CWHN_HPVjuly30.pdf Executive Summary Cancer prevention remains a high priority for women and men in Canada, and critical steps for cancer prevention are identifying and eliminating the causes of such diseases. The federal government's recently-announced $300 million investment toward a program for vaccinating girls and women with the currently available human papillomavirus (HPV) vaccine, Gardasil (manufactured by Merck Frosst) framed by some as a way to prevent cervical cancer in Canada, has generally been welcomed by a wide range of commentators. The policy commitment to improve the health of women and girls is laudable and emerging research about the effectiveness of immunization in reducing HPV prevalence is promising. However, although HPV infection is necessary for the development of cervical cancer, and while evidence suggests that Gardasil may prevent primary infection with HPV types 16 and 18 (currently thought to be a necessary cause of about 70 per cent of cervical cancer cases), we propose that these facts be assessed within a broad context, which at this moment contains many unknowns, before immunization policies are developed and implemented. A careful review of the literature, including that which was submitted by the manufacturer with its application for approval of Gardasil, reveals a sufficient number of unanswered questions to lead us to conclude that a universal immunization program aimed at girls and women in Canada is, at this time, premature and could possibly have unintended negative consequences for individuals and for society as a whole. We suggest that rather than giving widespread administration of this vaccine a “green light,” a more appropriate policy at this time would be a “yellow light” of caution. We recommend that the funding announced by the federal government be used to support the research needed to answer the many questions outlined below; to fund a public education campaign to quell the unfounded anxiety that has been instilled by marketers of the vaccine that HPV represents a “new” or “imminent” threat; and to ensure equal access to Pap testing, including timely follow-up and application of improvements in testing. Only when there is a solid evidence base and an appropriately-provisioned cervical screening program accessible to all can we determine the most appropriate holistic strategy – and the place of vaccination in it – to address cervical cancer and the transmission of HPV between and among Canadian girls, boys, women, and men. We have been given an exciting opportunity to establish effective guidelines and to create a model of how to approach future vaccines. We must take full advantage of it. In this paper, we summarize some of the major questions and concerns that need to be addressed before there is a full-scale roll-out of an HPV vaccination program. These closely reflect issues raised in the analytical framework created by Erickson et al.[i] in the context of the development of the National Immunization Strategy (NIS), and support efforts to ensure a comprehensive and systematic evaluation of all relevant factors before decisions regarding the importance of a new immunization program are made. As well, they echo some of the research questions identified as important in the Final Report from the Canadian Human Papillomavirus Vaccine Research Priorities Workshop held in Quebec City in 2005.[ii]We hope raising these questions now will contribute to the deliberations necessary to ensure a responsible and transparent evidence-based decision-making process. Our major points, summarized here, are discussed in detail in the text that follows. They are also summarized in a Commentary appearing in the 28 August 2007 issue of the Canadian Medical Association Journal (CMAJ), online as of 1 August 2007. There is no epidemic of cervical cancer in Canada . According to Canadian Cancer Statistics 2006,[iii] approximately 400 women were anticipated to die of this disease in 2006. Invasive cervical cancer typically follows a slowly progressive course that can be halted at one of various stages. Consequently, deaths associated with cervical cancer, relatively rare in Canada, but always unfortunate and not distributed evenly among women, must be considered as a failure in the adequate support of both the primary care and reproductive health services that would guarantee healthy living conditions for all women as well as ensure all women get appropriate Pap testing and follow-up. Most HPV infections are cleared spontaneously. Recent research using available molecular detection technologies suggests that clearance occurs within one year for about 70 per cent of those infected, and within two years for 90 per cent. Thus, HPV infection and cervical cancer must not be conflated: most women who are infected with even a “high-risk” strain of HPV will not develop cervical cancer.[iv] The nature of an immunization program is necessarily dependent upon the definition of clear and tangible goals. To date, such goals have not been made explicit with regard to a Canadian initiative. Is the aim of the vaccination program the eradication of high-risk HPV types from the population? Or is the aim to reduce the number of cervical cancer deaths? These different goals require different strategies. Information about the efficacy of Gardasil appears promising, but remains uncertain. Recent reports seem to suggest that Gardasil 's efficacy may be significant only for grade 2 cervical intraepithelial neoplasia (potentially removable pre-cancerous lesions 40 per cent of which regress spontaneously and which may not even be recommended for treatment), while the data are “insufficient to support a conclusion of efficacy for grade 3 cervical intraepithelial neoplasia or adenocarcinoma in situ.”[v] Related to this are other unknowns about the vaccine's effectiveness in the “real world” including the possible need for booster shots, concerns about altering the natural history of viral infection, and the impact of vaccination programs on safer sex practices and Pap screening rates, all of which highlight the essential need for careful health services research for the development of appropriate vaccination policies. Relatively few young girls (about 1200 aged 9 – 15 years) were enrolled in the clinical trials of Gardasil. Of these, a mere 100 were nine years of age, with the youngest being followed for only 18 months.[vi] Yet, based on the assumption that they will not yet have been exposed to HPV viruses, girls in this age group represent the priority “target” population for mass vaccination. Clearly, this is a very weak information base on which to construct a policy of mass vaccinations for all girls aged 9 to 13, as per the National Advisory Committee on Immunization's (NACI) recommendations.[vii] Rigorous collection and analysis of reports on adverse effects are needed for risk-benefit assessments that would allow for truly informed consent by individuals offered the vaccine. A list of adverse events is being compiled in the USA Food and Drug Administration (FDA) Vaccine Adverse Event Reporting System (VAERS)[viii] database, but because these reports are both incomplete and hard to interpret, there remains a need for careful and unbiased analyses of harm. Media and marketing claims about the impact of HPV prevalence are very misleading and the naming of Gardasil as the “cervical cancer vaccine,” implying the vaccine eliminates all cervical cancer, is incorrect. The marketing of Gardasil , which began in the United States even before it had been approved by the FDA, has made it difficult for there to be reflective discussions between parents and children, health care providers and their clients, as well as among the public and policy makers, about the nature and meaning of HPV and of vaccination. There is a great need for cost/effectiveness analyses of proposed vaccination programs, since the “added value” of the vaccine is far from clear: girls and women, even if vaccinated, will still need to practice safe(r) sex and have access to existing reproductive and primary care programs – not only for Pap testing, but for other aspects of reproductive care as well. Such analyses are usually done prior to the initiation of a mass vaccination program to ensure that the most efficient and appropriate approaches are taken. Notes: i Erickson LJ, De Wals P, and Farand L. An analytical framework for immunization programs in Canada . Vaccine . 2005; 23: 2468-2474. ii Public Health Agency of Canada . Canadian Human Papillomavirus Vaccine Research Priorities Workshop: Final Report. November 17 th -18 th , 2005 ; Quebec City . CCDR 2006;32S1:66. http://www.phac-aspc.gc.ca/publicat/...2s1/index.html. iii Canadian Cancer Society and National Cancer Institute of Canada . Canadian Cancer Statistics 2006. Toronto , Canada , 2006. iv Public Health Agency of Canada . What everyone should know about Human Papillomavirus (HPV): Questions and Answers. http://www.phac-aspc.gc.ca/std-mts/h...ph-qaqr_e.html (Accessed February 20, 2007 ). v Sawaya G, and Smith-McCune K. HPV Vaccination- More Answers, More Questions. The New England Journal of Medicine . 2007; 356: 1991-1993. vi Rabin, R. “A new vaccine for girls: but should it be compulsory?” New York Times , July 18 th , 2007 . vii National Advisory Committee on Immunization (NACI), Statement on human papillomavirus vaccine . Canada Communicable Disease Report . Februrary 2007; 33, ACS-2 15. viii U.S. Food and Drug Administration. Vaccine Adverse Event Report System (VAERS) http://www.fda.gov/cber/vaers/vaers.htm . Accessed 24 May 2007 . Posted: August 1, 2007 |
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